Federal Register Vol. 82, No.113,

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

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

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

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

On September 13, 2013, Embraer applied for an amendment to Type Certificate No. A57NM to include the new Model ERJ 190-300 airplane. The Model ERJ 190-300 airplane, which is a derivative of the Embraer Model ERJ 190-100 STD airplane currently approved under Type Certificate No. A57NM, is a 97- to 114-passenger transport-category airplane, designed with a new wing with a high aspect ratio and raked wingtip, and a new electrical-distribution system. The maximum take-off weight is 124,340 lbs (56,400 kg).

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Embraer must show that the Model ERJ 190-300 airplane meets the applicable provisions of the regulations listed in Type Certificate No. A57NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model ERJ 190-300 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Embraer Model ERJ 190-300 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

The Embraer Model ERJ 190-300 airplane will incorporate the following novel or unusual design feature: A digital-systems network architecture requiring isolation or protection from unauthorized internal access.

Networks, both in safety-related and non-safety-related applications, have been implemented in existing commercial-production airplanes. However, network security considerations and functions have played a relatively minor role in the certification of such systems because of the isolation, protection mechanisms, and limited connectivity between these networks.

To provide an understanding of the airplane electronic equipment, systems, and assets, these special conditions use the concept of domains. However, this does not prescribe any particular architecture.

The aircraft-control domain consists of the airplane electronic systems, equipment, instruments, networks, servers, software and hardware components, databases, etc., which are part of the type design of the airplane and are installed in the airplane to enable the safe operation of the airplane. These can also be referred to as flight-safety-related systems, and include flight controls, communication, display, monitoring, navigation, and related systems.

The operator-information domain generally consists of functions that the airplane operator manages or controls, such as administrative functions and cabin-support functions.

The passenger-entertainment domain consists of all functions required to provide the passengers with information and entertainment systems.

The Embraer Model ERJ 190-300 airplane design introduces the potential for access to the aircraft-control domain and airline-information-services domain by unauthorized persons through the passenger-information-services domain; and the security vulnerabilities related to the introduction of viruses, worms, user mistakes, and intentional sabotage of airplane networks, systems, and databases.

For electronic systems-and-assets security in these domains, the level of protection provided against security threats should be based on a security-risk assessment, noting that the level of protection could differ between domains and within domains, depending on the security threat. For each security vulnerability and airplane electronic asset, Embraer should identify in which domain the asset will be addressed.

In addition, the operating systems for current airplane systems are usually and historically proprietary. Therefore, they are not as susceptible to corruption from worms, viruses, and other malicious actions as are more-widely used commercial operating systems, such as Microsoft Windows, because access to the design details of these proprietary operating systems is limited to the system developer and airplane integrator. Some systems installed on the Embraer Model ERJ 190-300 airplane will use operating systems that are widely used and commercially available from third-party software suppliers. The security vulnerabilities of these operating systems may be more widely known than are the vulnerabilities of proprietary operating systems that the avionics manufacturers currently use.

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

As discussed above, these special conditions are applicable to the Embraer Model ERJ 190-300 airplane. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

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

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Embraer Model ERJ 190-300 airplanes.

1. The applicant must ensure that the airplane design provides isolation from, or airplane electronic-system security protection against, access by unauthorized sources internal to the airplane. The design must prevent inadvertent and malicious changes to, and all adverse impacts upon, airplane equipment, systems, networks, or other assets required for safe flight and operations.

2. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post-type-certification modifications that may have an impact on the approved electronic-system security safeguards.

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

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

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

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

On September 13, 2013, Embraer applied for an amendment to Type Certificate No. A57NM to include the new Model ERJ 190-300 airplane. The Model ERJ 190-300 airplane, which is a derivative of the Embraer Model ERJ 190-100 STD airplane currently approved under Type Certificate No. A57NM, is a 97- to 114-passenger transport-category airplane, designed with a new wing with a high aspect ratio and raked wingtip, and a new electrical-distribution system. The maximum take-off weight is 124,340 lbs (56,400 kg).

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Embraer must show that the Model ERJ 190-300 airplane meets the applicable provisions of the regulations listed in Type Certificate No. A57NM, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Model ERJ 190-300 airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

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

In addition to the applicable airworthiness regulations and special conditions, the Embraer Model ERJ 190-300 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34 and the noise-certification requirements of 14 CFR part 36.

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

The Embraer Model ERJ 190-300 airplane will incorporate the following novel or unusual design feature:

A digital-systems network architecture composed of several connected networks. This network architecture and network configuration will have the capability to allow access to or by external network sources, and may be used for or interfaced with a diverse set of functions, including:

• Flight-safety-related control, communication, and navigation systems (airplane-control domain);

• Operator business and administrative support (operator-information domain); and

• Passenger information and entertainment systems (passenger-entertainment domain)

The Embraer Model ERJ 190-300 airplane's digital-systems network architecture is novel or unusual for commercial transport airplanes as it allows connection to airplane electronic systems and networks, and access from sources external to the airplane (e.g., operator networks, wireless devices, Internet connectivity, service-provider satellite communications, electronic flight bags, etc.) to the previously isolated airplane electronic assets. Airplane electronic assets include electronic equipment and systems, instruments, networks, servers, software and electronic components, field-loadable software and hardware applications, databases, etc. This proposed design may result in network security vulnerabilities from intentional or unintentional corruption of data and systems required for the safety, operation, and maintenance of the airplane.

The existing regulations and guidance material did not anticipate these types of digital-system architectures, nor access to airplane systems. Furthermore, 14 CFR part 25, and current system-safety assessment policy and techniques, do not address potential security vulnerabilities by unauthorized access to airplane data busses and servers. Therefore, these special conditions are issued to ensure that the security, integrity, and availability of airplane systems are not compromised by certain wired or wireless electronic connections between airplane data busses and networks.

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

As discussed above, these special conditions are applicable to the Embraer Model ERJ 190-300 airplane. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.

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

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

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for electronic system-security protection from unauthorized external access on Embraer S.A. Model ERJ 190-300 airplanes.

1. The applicant must ensure that the airplane electronic systems are protected from access by unauthorized sources external to the airplane, including those possibly caused by maintenance activity.

2. The applicant must ensure that electronic system-security threats are identified and assessed, and that effective electronic system-security protection strategies are implemented to protect the airplane from all adverse impacts on safety, functionality, and continued airworthiness.

3. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post-type-certification modifications that may have an impact on the approved electronic system-security safeguards.

On September 20, 2016, BIS published a final rule entitled, “Wassenaar Arrangement 2015 Plenary Agreements Implementation, Removal of Foreign National Review Requirements, and Information Security Updates” (81 FR 64656-64692), (WA15 rule). The Wassenaar Arrangement (WA) on Export Controls for Conventional Arms and Dual-Use Goods and Technologies is a group of 41 like-minded states committed to promoting responsibility and transparency in the global arms trade, and preventing destabilizing accumulations of arms. As a Participating State, the United States has committed to controlling for export all items on the WA control lists. The lists were first established in 1996 and have been revised annually thereafter. Proposals for changes to the WA control lists that achieve consensus are approved by Participating States at annual Plenary meetings. Participating States are charged with implementing the agreed list changes as soon as possible after approval. The United States' implementation of WA list changes ensures U.S. companies have a level playing field with their competitors in other WA Participating States. This rule affects three sections of the EAR by correcting citations, replacing text that was inadvertently removed, and correcting other errors associated with the publication of the September 20th WA15 rule.

The introductory paragraph of § 740.13 (License Exception TSU) of the EAR is corrected by removing the reference to “encryption source code (and corresponding object code) that would be considered publicly available under § 734.3(b)(3) of the EAR,” because the publicly available provisions for encryption were moved to § 742.15(b) in the WA15 rule. This action also adds to the introductory paragraph a reference to “release of technology and source code in the United States by U.S. universities to their bona fide and full time regular employees” as that authorization was added in § 740.13(f) of the EAR by the initial implementation rule (78 FR 22718), April 16, 2013.

This correcting action makes three changes to § 740.17 of the EAR, as described below.

In § 740.17, a Note that was inadvertently removed by the WA15 rule is added to introductory paragraph (b). The Note was omitted by error when the mass market provisions were moved from § 742.15(b) to § 740.17(b) in order to consolidate these provisions in one place.

Also in § 740.17, paragraph (b)(2)(i) is amended by replacing the incorrect reference to non-existing paragraph (a)(i)(A) and adding in its place the correct reference to paragraph (b)(2)(i)(A).

This correction rule amends the Notes to paragraph (a) by revising paragraph (6) to replace the reference to Note 1 to Category 5, Part II with a reference to Supplement No. 2 to part 774 of the EAR because Note 1 to Category 5, Part II was removed by the WA15 rule and replaced with the Supp. No. 2 reference.

Although the Export Administration Act of 1979, as amended, expired on August 21, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations (EAR) in effect under the International Emergency Economic Powers Act (50 U.S.C. 1701 et seq.). BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222, as amended by Executive Order 13637.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” as defined under Executive Order 12866.

2. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

3. The provisions of the Administrative Procedure Act requiring notice of proposed rulemaking, the opportunity for public participation, and a 30-day delay in effective date (5 U.S.C. 553) are inapplicable, because this regulation involves a military and foreign affairs function of the United States (5 U.S.C. 553(a)(1)). Immediate implementation of these amendments fulfills the United States' international obligation to the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies (Wassenaar Arrangement). The Wassenaar Arrangement contributes to international security and regional stability by promoting greater responsibility in transfers of conventional arms and dual use goods and technologies, thus preventing destabilizing accumulations of such items. The Wassenaar Arrangement consists of 41 member countries that act on a consensus basis, and the changes set forth in this action make technical corrections to regulations implementing agreements reached at the December 2015 plenary session of the Wassenaar Arrangement. Because the United States is a significant exporter of the items covered by this rule, implementation of this rule is necessary for the Wassenaar Arrangement to achieve its purpose. Any delay in implementation will create a disruption in the movement of affected items globally, because of disharmony between export control measures implemented by Wassenaar Arrangement members, resulting in tension between member countries. Export controls work best when all countries implement the same export controls in a timely manner. Delaying this rulemaking to allow for notice and comment and a 30-day delay in effectiveness would prevent the United States from fulfilling its commitment to the Wassenaar Arrangement in a timely manner, and would injure the credibility of the United States in this and other multilateral regimes.

In addition, issuing a notice of proposed rulemaking would be inappropriate and contrary to the public interest in this instance, as this rule is merely making corrections to a previously published final rule.

Although there is no formal comment period, public comments on this final rule are welcome on a continuing basis. Comments should be submitted to Sharron Cook, Office of Exporter Services, Bureau of Industry and Security, Department of Commerce, 14th and Pennsylvania Ave. NW., Room 2099, Washington, DC 20230.

4. Because this action merely makes technical correcting amendments to the previously published WA15 final rule, the analysis required by the the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) that is contained in the WA15 final rule continues to apply to the regulatory text that is corrected by this action, and no additional analysis is necessary.

Accordingly, parts 740 and 774 of the Export Administration Regulations (15 CFR parts 730 through 774) are amended as follows:

I. Table of Abbreviations COTP Captain of the Port Duluth CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background, Purpose, and Legal Basis

On March 30, 2017 the Coast Guard published an NPRM in the Federal Register (82 FR 15662) entitled “Special Local Regulation; Breakers to Bridge Paddle Festival, Lake Superior, Keweenaw Waterway, MI.” The NPRM proposed to establish a no-wake zone within the Keweenaw Waterway on an annual basis during the Breakers to Bridge Paddle Festival, and invited comments on our proposed regulatory action related to this fireworks display. The aforementioned NPRM was open for comment for 30 days, in which no comments were received.

As noted above, we received no comments on our NPRM published on March 30, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.

This rule creates a permanent special local regulation in the Keweenaw Waterway for the annual Breakers to Bridge Paddle Festival that historically takes place in the within the first two weeks of September. The no-wake zone will be enforced on all vessels entering a portion of the Keweenaw Waterway beginning at the North Entry at position 47°14′03″ N., 088°37′53″ W.; and ending at the Portage Lake Lift Bridge at position 47°07′25″ N., 088°34′26″ W. All vessels transiting through the no-wake zone will be required to travel at an appropriate rate of speed that does not create a wake except as may be permitted by the Captain of the Port Duluth (COTP) or a designated representative. The precise times and date of enforcement for this special local regulation will be determined annually.

The COTP will use all appropriate means to notify the public when the special local regulation in this rule will be enforced. Such means may include publication in the Federal Register a Notice of Enforcement, Broadcast Notice to Mariners, and Local Notice to Mariners. The regulatory text appears at the end of this document.

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

E.O.s 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits including potential economic, environmental, public health and safety effects, distributive impacts, and equity. E.O.13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”), directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

The Office of Management and Budget (OMB) has not designated this rule a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has not reviewed it.

As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum titled “Interim Guidance Implementing Section 2 of the Executive Order of January 30, 2017 titled `Reducing Regulation and Controlling Regulatory Costs' ” (February 2, 2017).

This regulatory action determination is based on the size, location, duration, and time-of-year of the Special Local Regulation. Vessel traffic will be able to safely transit through the no-wake zone which will impact only a portion of the Keweenaw Waterway between the North Entry and the Portage Lake Lift Bridge located in Houghton, MI during a time of year when commercial vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16.

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

While some owners or operators of vessels intending to transit through the no-wake zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a no-wake zone being enforced for no more than 6 hours along a prescribed route between the North Entry & Portage Lake Lift Bridge within the Keweenaw Waterway in Michigan. Normally such actions are categorically excluded from further review under paragraph 34(h) of Figure 2-1 of Commandant Instruction M16475.lD. A preliminary environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES.

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

I. Table of Abbreviations CFR Code of Federal Regulations DHS Department of Homeland Security FR Federal Register LCDR Lieutenant Commander LNM Local Notices to Mariners LWRP Low Water Reference Plane MNSA Maritime Navigation Safety Association ANPRM Advanced Notice of Proposed Rulemaking NPRM Notice of Proposed Rulemaking §  Section U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard establishes anchorage grounds under authority in 33 U.S.C. 471. As stated in title 33 Code of Federal Regulation (CFR) 109.05 (33 CFR 109.05), this authority has been delegated to U.S. Coast Guard District Commanders. On April 3, 2015, the Coast Guard published an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register (FR) (80 FR 18175) proposing to expand existing and establish new anchorages. An ANPRM is used to test a proposal or solicit ideas, involving interested persons in a potential regulatory action before issuing a formal rulemaking or a Notice of Proposed Rulemaking (NPRM). An agency is not required to publish an ANPRM but may choose to do so.

The Coast Guard is issuing this interim rule without the prior notice and opportunity to comment through the NPRM process, pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment through the NPRM process when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because it is impracticable. This rule will reduce vessel traffic congestion, and decrease the distance between anchorages during the most congested and demanding navigation period. This rule will also assist in maintaining safe navigation and movement of commerce during the high water and increased current conditions present now on the Lower Mississippi River. Delaying implementation of this rule would deny a safer working environment for all mariners utilizing the waterway. Soliciting and responding to comments on an NPRM would delay the margin of safety these new and additional anchorage areas have to offer both the mariners and the port until after the most congested and demanding time of the year—see additional details of hazards and risks in Purpose and Legal Basis section below. This interim rule follows an ANPRM requesting public participation and comments to better assess the need for additional anchorage areas. Comments to the ANPRM included support for additional anchorage areas in general, constructive suggestions, and a request to expand an additional anchorage. Zero comments opposed the new anchorage areas as proposed in the ANPRM. Additionally, the Coast Guard seeks to receive comment while this interim rule is in effect during the most congested and demanding time of the year.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date to provide a full 30 days' notice is impracticable. Immediate implementation is needed to provide a safer working environment for all mariners utilizing this waterway.

The Coast Guard received requests from the Crescent River Port Pilots' Association and the New Orleans Baton Rouge River Pilots Association to amend an existing anchorage and establish two new anchorages. These requests were presented and discussed at a Maritime Navigation Safety Association (MNSA) meeting on August 12, 2014 and at a Port Safety Council Meeting on September 10, 2014. Attendees at those meetings did not comment on or object to the requests presented. The Coast Guard received a subsequent request, via a comment to the April 3, 2015 ANPRM, requesting expansion of an additional anchorage. The Coast Guard also observed that during grain season, typically occurring annually from December through May, the anchorages were at maximum capacity. This creates a hazardous condition as vessels experiencing a casualty had no safe anchorage to stop in and the closest safe anchorage for the vessel was further away than was prudent to transit with the casualty. Finally, due to high water conditions on the Lower Mississippi River, the Coast Guard received emergency requests from industry for additional anchorage area as these conditions are causing increased reliance on safe anchorage to manage transits during both high traffic season and high water. This rule will improve the overall safety of anchored vessels in the White Castle and Cedar Grove Anchorages and provide for two additional anchorage areas to address the increased waterway congestion and improve the overall safe and efficient flow of vessel traffic and commerce.

The distance between the two upper anchorages in the Lower Mississippi River, White Castle Anchorage MM 190.4 and Baton Rouge General Anchorage MM 228.5 is so great that a vessel suffering a casualty between them would become a hazard to the waterway. Plaquemines Point Anchorage was created to help mitigate the risk by reducing the distance between safe anchorage for deep draft vessels in the reach between White Castle Anchorage and Baton Rouge General Anchorage. The addition of the Plaquemines Point Anchorage reduces the greatest distance between anchorages at this stretch from 38.1 miles to 24.1miles.

The legal basis and authorities for this rule are found in 33 U.S.C. 471, 1221 through 1236, 2071; 33 CFR 1.05-1, Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to propose, establish, and define regulatory anchorages. Through this rulemaking, the Coast Guard is amending two existing anchorage grounds; Cedar Grove Anchorage, 33 CFR 110.195(a)(12) and White Castle Anchorage, § 110.195(a)(29), and is establishing two new permanent anchorage grounds; Point Michel Anchorage, § 110.195(a)(35), and Plaquemines Point Anchorage, § 110.195(a)(36).

The Coast Guard has consulted with the Chief of Engineers the Army Corps of Engineers, New Orleans District about the specific provisions of this interim rule, and the Chief of Engineers has recommended that we proceed with our amendment of two existing anchorage grounds and establishment of two addition anchorage grounds as specified in this rule.

This interim rule establishes two new anchorages and amends two established anchorages to provide necessary additional anchorage area while also requesting comments. While vessels are occupying the new and amended anchorage areas, the impact of this rule will be more apparent to mariners operating in these areas. We believe the mariner will therefore be more inclined to provide input and feedback on how the increased anchorage area is used and if such changes address the needs of the waterway. This feedback will aid the Coast Guard in finalizing these changes and designing better anchorage systems as needed in the future. Additionally, this rule is being timed to take effect during the most demanding maritime environment. During this time the river historically experiences high water levels with faster currents, low river levels with increased shoaling, fog season, and the increased outflow of goods due to grain harvest.

During the ANPRM comment period, the Coast Guard received support for establishing new anchorages and expanding existing anchorages. Four comments were submitted in support of Point Michel Anchorage and Cedar Grove Anchorage. Additionally, one comment requested that the Coast Guard also expand the White Castle Anchorage at Mile Marker 191 Above Head of Passes on the Lower Mississippi River. Therefore, this rule also expands White Castle Anchorage, as requested. It also adjusted the three anchorages discussed in the ANPRM and establishes Plaquemines Point Anchorage. One comment requested that the Coast Guard include latitude and longitude coordinates for the anchorage limits in addition to the textual description. The Coast Guard considered transitioning the anchorage geographic boundaries from Low Water Reference Plane (LWRP) and River Mile Markers (MM) to latitude and longitude coordinates while developing the ANPRM and found it would not add to the mariners' experience or clarity of the anchorage locations. Due to the ever-changing nature of the Lower Mississippi River, using LWRP as a reference for the anchorage boundaries will allow an anchorage to move with the river in the event that it shifts in vicinity of the anchorage. Using latitude and longitude could require the Coast Guard to amend the anchorage definition every time the U.S. Army Corps of Engineers adjusts the LWRP based on hydrographic survey data.

Therefore, through this interim rule with request for comments, the Coast Guard is establishing two new anchorages and increasing the size of two established anchorages. The two new anchorages are known as the Point Michel Anchorage, § 110.195(a)(35), and the Plaquemines Point Anchorage, § 110.195(a)(36). The two anchorages increased in size are the Cedar Grove Anchorage, § 110.195(a)(12), and the White Castle Anchorage, § 110.195(a)(29).

By increasing existing anchorages and establishing new anchorages, this interim rule increases the available anchorage areas in this section of the river necessary to accommodate vessel traffic; improves navigation safety, providing for the overall safe and efficient flow of vessel traffic and commerce; and aids and assists the economy through increased anchorage capacity, streamlining vessel throughput and increasing ship to port interactions. The additional anchorage area established by this interim rule and request for comments increases the safety of life and property on navigable waters, while ensuring that the needs and concerns of all stakeholders are addressed through the rulemaking comment process before making the new and increased anchorages permanent through a final rulemaking.

The Coast Guard is establishing Point Michel Anchorage as an area, 1.4-miles long and 500-feet wide along the right descending bank of the river extending from mile 40.8 to mile 42.2 Above Head of Passes. Its inner boundary is a line parallel to the nearest bank 325 feet from the water's edge into the river as measured from the LWRP. Its outer boundary of the anchorage is a line parallel to the nearest bank 825 feet from the water's edge into the river as measured from the LWRP.

Currently the Cedar Grove Anchorage, under § 110.195(a)(12), is an area extending 1.2 miles in length along the right descending bank of the river from mile 69.9 to mile 71.1 Above Head of Passes. The current width of the anchorage is 500 feet, and the inner boundary is a line parallel to the nearest bank 200 feet from the water's edge into the river as measured from the LWRP, with the outer boundary at a line parallel to the nearest bank 700 feet from the water's edge into the river as measured from the LWRP.

The Coast Guard is amending the Cedar Grove Anchorage to increase the anchorage's overall length by fourteen hundredths of a mile, shifting the lower limit down river from mile 69.9 to mile 69.56 and shifting the upper limit down river from mile 71.1 to mile 70.9.

Currently, the White Castle Anchorage, under § 110.195(a)(29), is an area extending 0.7 miles in length along the right descending bank of the river from mile 190.4 to mile 191.1 Above Head of Passes. The current width of the anchorage is 300 feet and its inner boundary is a line parallel to the nearest bank 400 feet from the water's edge into the river as measured from the LWRP, with an outer boundary at a line parallel to the nearest bank 700 feet from the water's edge into the river as measured from the LWRP.

The Coast Guard is amending the White Castle Anchorage to increase the anchorage's overall length by fourteen hundredths of a mile, shifting the lower limit down river from mile 190.4 to mile 190.3 and shifting the upper limit up river from mile 190.1 to mile 191.14.

The Coast Guard is establishing Plaquemines Point Anchorage as an area, 0.5 miles in length along the right descending bank of the river extending from mile 203.9 to mile 204.4 Above Head of Passes. The anchorage is 500 feet wide and its inner boundary is a line parallel to the nearest bank 400 feet from the water's edge into the river as measured from the LWRP. Its outer boundary is a line parallel to the nearest bank 900 feet from the water's edge into the river as measured from the LWRP.

We have placed illustrations of each of the four anchorages as amended or established by this rule in the docket, accessible as indicated under ADDRESSES.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

The impacts on routine navigation are expected to be minimal because the anchorage areas are established outside of the navigation channel and will not unnecessarily restrict vessel traffic. When the anchorages are not occupied, vessels will be able to maneuver in and through the anchorage areas, and when occupied there is still room for two-way deep draft traffic to pass.

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

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. This rule is amending two existing anchorage grounds and establishing two new anchorage grounds on a portion of the Lower Mississippi River. The new anchorages are being established and managed like all existing anchorages on the Lower Mississippi River. These anchorages are in the Federal Channel, a safe distance from shore, off revetment, in safe water, do not conflict with any other permit and do not impede safe navigation.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule will have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves amending two existing anchorage grounds and establishing two new anchorage grounds on a portion of the Lower Mississippi River. It is categorically excluded from further review under paragraph 34(f) of Figure 2-1 of Commandant Instruction M16475.lD. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

We encourage you to submit comments through the Federal eRulemaking Portal at http://www.regulations.gov. If your material cannot be submitted using http://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this interim rule, and all public comments, are in our online docket at http://www.regulations.gov and can be viewed by following that Web site's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted or a final rule is published.

We accept anonymous comments. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 110 as follows:

The Coast Guard will enforce the regulations in 33 CFR 165.1124 for a safety zone on the Colorado River in Laughlin, Nevada for the Avi Resort and Casino Labor Day Fireworks in 33 CFR 165.1124, Table 1, Item 4 of that section from 8 p.m. through 10 p.m. on September 3, 2017. This enforcement action is being taken to provide for the safety of life on navigable waterways during the fireworks event. Our regulation for annual fireworks events on the Colorado River within the San Diego Captain of the Port Zone identifies the regulated area for this event. Under the provisions of 33 CFR 165.1124, a vessel may not enter the regulated area, unless it receives permission from the Captain of the Port, or his designated representative. Spectator vessels may safely transit outside the regulated area but may not anchor, block, loiter, or impede the transit of participants or official patrol vessels. The Coast Guard may be assisted by other Federal, State, or Local law enforcement agencies in enforcing this regulation.

This document is issued under authority of 33 CFR 165.1124 and 5 U.S.C. 552 (a). In addition to this document in the Federal Register, the Coast Guard will provide the maritime community with advance notification of this enforcement period via the Local Notice to Mariners and local advertising by the event sponsor.

If the Captain of the Port or his designated representative determines that the regulated area need not be enforced for the full duration stated on this document, he or she may use a Broadcast Notice to Mariners or other communications coordinated with the event sponsor to grant general permission to enter the regulated area.

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

On April 11, 2017, Gilligan's Pier of Newburg, MD, notified the Coast Guard that it will conduct a fireworks display starting at 9 p.m. on June 17, 2017. The fireworks display will be launched from a barge located on the Potomac River, in Charles County near Newburg, MD. In the event of inclement weather, the fireworks display will be rescheduled for June 24, 2017. On May 5, 2017 the Coast Guard published a notice of proposed rulemaking (NPRM) titled “Safety Zone; Potomac River, Newburg, MD” (82 FR 21153). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to this fireworks display. During the comment period that ended June 5, 2017, we received no comments.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Delaying the effective date of this rule would be contrary to public interest because immediate action is needed to respond to the potential safety hazards associated with a fireworks display from a barge on navigable waters.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The COTP has determined that potential hazards associated with the launching of fireworks over navigable waters scheduled for June 17, 2017 will be a safety concern for anyone within 200 yards of the firework barge. The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within the safety zone before, during, and after the scheduled event.

As noted above, the Coast Guard received no comments on its NPRM published May 5, 2017. There are no changes in the regulatory text of this rule from the proposed rule published in the Federal Register.

This rule establishes a safety zone from 8:30 p.m. through 10 p.m. on June 17, 2017, and if necessary due to inclement weather, from 8:30 p.m. through 10 p.m. on June 24, 2017. The safety zone will cover the navigable waters of the Potomac River, within 200 yards radius of a fireworks barge in approximate position latitude 38°23′45.2″ N., longitude 076°59′31.8″ W., located near Newburg, MD. The duration of the safety zone is intended to ensure the safety of vessels and the navigable waters before, during, and after the scheduled twenty minute fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.

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

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget.

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which will impact a small designated area of the Potomac River for 11/2 hours during the evening when vessel traffic is normally low. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting 1-1/2 hours that will prohibit entry within 200 yards of a fireworks discharge barge. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of Commandant Instruction M16475.lD. A Record of Environmental Consideration (REC) supporting this determination is available in the docket where indicated under ADDRESSES.

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

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

I. Background

The SIP is a living document which a state revises as necessary to address its unique air pollution problems. Therefore, EPA, from time to time, must take action on SIP revisions containing new and/or revised regulations as being part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference federally-approved SIPs, as a result of consultations between EPA and the Office of the Federal Register (OFR). The description of the revised SIP document, IBR procedures and “Identification of plan” format are discussed in further detail in the May 22, 1997 Federal Register document. On February 10, 2005 (70 FR 7024), EPA published a Federal Register document beginning the new IBR procedure for West Virginia. On February 28, 2007 (72 FR 8903), February 10, 2009 (74 FR 6542), December 28, 2010 (75 FR 81474) and July 25, 2013 (78 FR 44884), EPA published updates to the IBR material for West Virginia.

Since the publication of the last IBR update, EPA has approved into the SIP the following regulatory changes to the following West Virginia regulations:

1. EPA-Approved Regulations and Statutes 6B-1-3 (West Virginia Code 6B-Ethics Standards and Financial Disclosure), sections 6B-1-3, 6B-2-6 and 6B-2-7.

1. 45 CSR 8 (Ambient Air Quality Standards), sections 45-8-1 through 45-8-4.

2. 45 CSR 13 (Permits for Construction, Modification, Relocation and Operation of Stationary Sources of Air Pollutants, Notification Requirements, Temporary Permits, General Permits, and Procedures for Evaluation), section 45-13-1 through 45-13B.

3. 45 CSR 14 (Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution for the Prevention of Significant Deterioration), section 45-14-1 through 45-14-26.

4. 45 CSR 19 (Permits for Construction and Major Modification of Major Stationary Sources of Air Pollution which Cause or Contribute to Nonattainment), section 45-19-1 through 45-19B.

1. 45 CSR 8, sections 45-8-5 through 45-8-7.

In this action, EPA is announcing the update to the IBR material as of July 1, 2016 and revising the text within 40 CFR 52.2520(b).

EPA is revising our 40 CFR part 52 “Identification of Plan” for the State of West Virginia regarding incorporation by reference, § 52.2520(b). EPA is revising § 52.2520(b)(1) to clarify that all SIP revisions listed in paragraphs (c) and (d), regardless of inclusion in the most recent “update to the SIP compilation,” are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking in which EPA approved the SIP revision, consistent with following our “Approval and Promulgations of Air Quality Implementation Plans; Revised Format of 40 CFR part 52 for Materials Being Incorporated by Reference,” effective May 22, 1997 (62 FR 27968). EPA is revising § 52.2520(b)(2) to clarify references to other portions of paragraph (b) with paragraph (b)(2). EPA is revising paragraph (b)(3) to update address and contact information.

EPA is also revising entries at 40 CFR 52.2520(c) in the “State Citation” column for Regulation 45 CSR 8 (Ambient Air Quality Standards) to read “Section 45-8-1,” “Section 45-8-2,” “Section 45-8-3,” and “Section 45-8-4.”

EPA has determined that this rule falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedures Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make a rule effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This rule simply codifies provisions which are already in effect as a matter of law in federal and approved state programs. Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment is “unnecessary” and “contrary to the public interest” since the codification only reflects existing law. Immediate notice in the CFR benefits the public by removing outdated citations and incorrect table entries.

In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of previously EPA approved regulations promulgated by the State of West Virginia and federally effective prior to July 1, 2016. Therefore, these materials have been approved by EPA for inclusion in the SIP, have been incorporated by reference by EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of EPA's approval, and will be incorporated by reference by the Director of the Federal Register in the next update to the SIP compilation.1 EPA has made, and will continue to make, these materials generally available through www.regulations.gov and/or at the EPA Region III Office (please contact the person identified in the “For Further Information Contact” section of this preamble for more information).

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

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

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

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

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

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

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

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

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

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

In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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

EPA has also determined that the provisions of section 307(b)(1) of the CAA pertaining to petitions for judicial review are not applicable to this action. Prior EPA rulemaking actions for each individual component of the West Virginia SIP compilations had previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, EPA sees no need in this action to reopen the 60-day period for filing such petitions for judicial review for this “Identification of plan” update action for West Virginia.

40 CFR part 52 is amended as follows:

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

The background for this action is discussed in detail in our November 21, 2016 proposal (81 FR 83184). In that proposed rule, we proposed to partially approve and partially disapprove the June 16, 2016, infrastructure SIP submission from Oklahoma, which addresses the requirements of CAA sections 110(a)(1) and (2) as applicable to the 2012 PM2.5 NAAQS. We also proposed to disapprove a portion of the January 28, 2015 i-SIP submission for the 2010 SO2 NAAQS. We proposed disapproval for both submissions only as to the portions that address CAA section 110(a)(2)(D)(i)(II); the requirement for visibility protection in other States. CAA section 110(a)(2)(D)(i)(II) requires the SIP for a new or revised NAAQS to contain adequate provisions to prohibit emissions which will interfere with required measures for any other State for (1) prevention of significant deterioration (PSD) of air quality or (2) visibility protection. We did not receive any comments regarding our proposal.

At this time, we are not acting on the portions of the 2012 PM2.5 and 2010 SO2 NAAQS i-SIP submissions that address CAA section 110(a)(2)(D)(i)(II) as it relates to visibility protection in other States. We also note that the State did not address CAA section 110(a)(2)(D)(i)(I) 1 in the June 16, 2016 submittal for the 2012 PM2.5 NAAQS, thus we are not taking action to approve or disapprove the requirements for that section. The State submitted an i-SIP revision to address the requirements in CAA section 110(a)(2)(D)(i)(I) for the 2012 PM2.5 NAAQS on December 19, 2016; we expect to act on that submittal at a later time.

We are approving the portions of the June 16, 2016 Oklahoma infrastructure SIP submission for the 2012 PM2.5 NAAQS that address CAA sections 110(a)(2)(A), (B), (C), (D)(i)(II) as it relates to the prevention of interference with PSD, (D)(ii), (E)(i), (E)(ii), (F), (G), (H), (J), (K), (L) and (M). The i-SIP addresses how the existing SIP provides for implementation, maintenance, and enforcement of the 2012 PM2.5 NAAQS and is adequate to meet the State's responsibilities under the CAA.

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 14, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

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

In 2008 we revised the 8-hour ozone primary and secondary NAAQS to a level of 0.075 parts per million (ppm) to provide increased protection of public health and the environment (73 FR 16436, March 27, 2008). The 2008 8-hour ozone NAAQS replaced the 1997 8-hour ozone NAAQS of 0.08 ppm. The DFW area was classified as a “Moderate” ozone nonattainment area for the 2008 8-hour ozone NAAQS and initially given an attainment date of no later than December 31, 2018 (77 FR 30088 and 77 FR 30160, May 21, 2012). The DFW area consists of Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall, Tarrant and Wise counties.

On December 23, 2014, the D.C. Circuit Court issued a decision rejecting, among other things, our attainment deadlines for the 2008 ozone nonattainment areas, finding that we did not have statutory authority under the CAA to extend those deadlines to the end of the calendar year. NRDC v. EPA, 777 F.3d 456, 464-69 (D.C. Cir. 2014). Consistent with the court's decision we modified the attainment deadlines for all nonattainment areas for the 2008 ozone NAAQS, and set the attainment deadline for all 2008 Moderate ozone nonattainment areas, including the DFW area as July 20, 2018 (80 FR 12264, March 6, 2015).

On July 10, 2015, Texas submitted a SIP revision for the DFW area based on an attainment date of December 31, 2018. Texas further revised the SIP to address an attainment date of July 20, 2018 and submitted it on August 5, 2016. Copies of the SIP revisions are available at www.regulations.gov, Docket number EPA-R06-OAR-2015-0833.

As a moderate ozone nonattainment area and under the anti-backsliding requirements of the previous standards, Texas is required to implement I/M and NNSR programs. These were also requirements under the previous ozone standards. In the August 5, 2016 SIP revision Texas discusses these requirements and noted: (1) That the DFW area meets the CAA requirements to implement an I/M program and (2) since the Dallas/Fort Worth 1997 ozone nonattainment area was not redesignated to attainment prior to the revocation of the 1979 1-hour ozone NAAQS and the 1997 ozone NAAQS, anti-backsliding NNSR requirements for Serious areas still apply. Texas also noted that a redesignation substitute demonstration was submitted for the 1997 ozone NAAQS to satisfy anti-backsliding requirements for the revoked NAAQS in the DFW area. Anti-backsliding requirements ensure air quality in nonattainment areas does not get worse after an air quality standard is revoked (81 FR 81276, 81288, November 17, 2016). The EPA approved Texas SIP (Texas SIP) that incorporates by reference the state's regulations can be found at 40 CFR 52.2270(c).

I/M refers to the inspection and maintenance programs for in-use vehicles required under the CAA. The applicable requirements for ozone nonattainment areas that are required to adopt I/M programs are described in CAA sections 182(a)(2)(B), 182(b)(4), 182(c)(3), and 184(b)(1)(A) and further defined in 40 CFR 51.350 (“Applicability”) of the I/M rule (40 CFR part 51, subpart S). Under these cumulative requirements, Moderate ozone nonattainment areas in urbanized areas with 1990 Census populations of 200,000 or more are required to adopt basic I/M programs, while Serious and higher classified ozone nonattainment areas outside of the northeast Ozone Transport Region with 1980 Census-defined urbanized populations of 200,000 or more are required to adopt enhanced I/M programs (40 CFR 51.350(a)(2) and (4)).

Previously, we revoked (1) the 1979 1-hour ozone NAAQS (69 FR 23951, April 30, 2004 and 70 FR 44470, August 3, 2005) and (2) the 1997 8-hour ozone NAAQS (80 FR 12264, March 6, 2015). Because the DFW area was classified as Serious nonattainment for these revoked ozone NAAQS, an enhanced I/M program is required in the DFW area for anti-backsliding purposes (40 CFR 51.1100(o)). Ozone classifications can be found in CAA section 181 and 40 CFR 51.1103. The Serious classification is one classification higher than the Moderate classification.

The Texas SIP includes 30 TAC Section 114.2 (Inspection and Maintenance Definitions) and 30 TAC Section 114.50 (Vehicle Emissions Inspection Requirements) except for 30 TAC Section 114.50(b)(2). In a 2001 final rule, we did not approve 30 TAC Section 114.50(b)(2) as part of the Texas SIP as (1) it placed an additional reporting burden upon commanders at Federal facilities regarding affected Federal vehicles that is not imposed upon any other affected non-federal vehicle and (2) additional reporting requirement is not an essential element for an approvable I/M program, since affected Federal vehicles are also subject to the same reporting requirements as other affected non-federal vehicles (66 FR 57261, 57262, November 14, 2001).

Under these provisions Collin, Dallas, Denton, Ellis, Johnson, Kaufman, Parker, Rockwall and Tarrant counties are included in an enhanced I/M program. An enhanced program is required for anti-backsliding purposes since these counties were classified as Serious nonattainment for the 1997 8-hour ozone NAAQS (75 FR 79302, December 20, 2010). The program requires that gasoline powered light-duty vehicles, and light and heavy-duty trucks between two and twenty-four years old, that are registered or required to be registered in the I/M program area, including fleets, are subject to annual inspection and testing. Wise County is not required to be included in the I/M program as it is not included in the urbanized area. See www2.census.gov/geo/pdfs/reference/ua/1990uas.pdf and www.census.gov/population/metro/files/lists/historical/90mfips.txt. Therefore, since the provisions in the Texas SIP already include the CAA I/M requirements for the DFW area, we are approving this portion of the SIP revisions.

The applicable NNSR requirements for the various ozone nonattainment classifications are described in CAA section 182 and further defined in 40 CFR part 51, subpart I (Review of New Sources and Modifications). Under these requirements new major sources or major modifications at existing sources in an ozone nonattainment area must comply with the lowest achievable emission rate and obtain sufficient emission offsets. The emission offset ratio required for Moderate ozone nonattainment areas is 1.15 to 1 (CAA section 182(b)(5)).

The Texas SIP includes 30 TAC Section 116.12 (Nonattainment and Prevention of Significant Deterioration Review Definitions) and 30 TAC Section 116.150 (New Major Source or Major Modification in Ozone Nonattainment Area). These provisions require new major sources or major modifications at existing sources in the DFW area to comply with the lowest achievable emission rate and obtain emission offsets at the Moderate classification ratio of 1.15 to 1. Therefore, since the provisions in the Texas SIP already include the CAA NNSR requirements for ozone nonattainment areas classified as Moderate, we are approving this portion of the SIP revision.

We note that at the time of the SIP revisions, except for Wise County, the Serious area NNSR permitting requirements for the 1997 8-hour ozone NAAQS applied for the DFW area to meet anti-backsliding requirements. Moderate area NNSR permitting requirements applied to Wise County. In November 2016, we approved a redesignation substitute for the DFW area, which addressed both the 1-hour and 1997 ozone standards. This action found that the area was meeting these standards and was expected to continue to meet these standards. Based on this finding, EPA, as part of the redesignation substitute, removed the Serious area NNSR requirement so that only Moderate area NNSR requirements apply to the DFW area (81 FR 78688, November 8, 2016).

We are approving revisions to the Texas SIP submitted on August 5, 2016, that pertain to 2008 ozone NAAQS requirements for vehicle I/M and NNSR for the DFW area. As discussed above, the Texas SIP includes provisions to implement these Moderate area ozone nonattainment requirements.

The EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on September 12, 2017 without further notice unless we receive relevant adverse comment by July 14, 2017. If we receive relevant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive relevant adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 14, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Samuel Coleman was designated the Acting Regional Administrator on June 1, 2017 through the order of succession outlined in Regional Order R6-1110.13, a copy of which is included in the docket for this action.

40 CFR part 52 is amended as follows:

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

For the purpose of this document, we are giving meaning to certain words or initials as follows:

(i) The word or initials CAA mean or refer to the Clean Air Act, unless the context indicates otherwise.

(ii) The initials CARB mean or refer to the California Air Resources Board.

(iii) The initials CFR mean or refer to Code of Federal Regulations.

(iv) The initials or words EPA, we, us or our mean or refer to the United States Environmental Protection Agency.

(v) The word or initials ICAPCD or District mean or refer to the Imperial County Air Pollution Control District, the agency with jurisdiction over stationary sources within Imperial County.

(vi) The initials NSR mean or refer to New Source Review.

(vii) The initials SIP mean or refer to State Implementation Plan.

On December 19, 2016, the EPA proposed a full approval of two rules and a limited approval and limited disapproval (LA/LD) of one rule (as noted in Table 1) submitted by CARB for incorporation into the ICAPCD portion of the California SIP. 81 FR 91895. Table 1 also lists the dates the rules were adopted by ICAPCD and submitted by CARB, which is the governor's designee for California SIP submittals.

Throughout this document “we,” “us,” or “our” each mean “the EPA.”

The background for this action is discussed in detail in the EPA's November 3, 2015 proposal.1 In that document, the EPA proposed to approve New Mexico's regional haze progress report SIP revision (submitted on March 14, 2014) as meeting the applicable regional haze requirements set forth in 40 CFR 51.309(d)(10). In addition, the EPA proposed to approve New Mexico's determination that the current regional haze SIP is adequate to meet the State's RPGs for the first planning period and requires no further substantive revision to achieve established goals for visibility improvement and emission reductions.

The proposal and the accompanying technical support document (TSD) provide detailed descriptions of New Mexico's SIP revision and the rationale for the EPA's proposed approval of the State's submittal. Please see the docket for these and other documents regarding the proposal.

The public comment period for the proposal closed on December 3, 2015. The EPA received one set of comments in a letter dated December 3, 2015, from the National Parks Conservation Association and the San Juan Citizens Alliance regarding the EPA's proposal. The comment letter is included in the publicly posted docket associated with this action at http://www.regulations.gov. Below, the EPA provides a summary of the comments received and corresponding responses. After careful consideration of the comments and the information provided, the EPA is approving the progress report, as proposed.

Comment: The commenter noted that New Mexico's progress report indicated that the State is no longer implementing its State Mobile Source Regulation but is relying on federal programs that will achieve the same reductions. The commenter argued that the progress report does not meet 40 CFR 51.309(d)(10)(i)(A) because it was not clear about the start date of the State's reliance on federal programs for mobile source reduction or the impact that a delayed start had on visibility.

Response: The comment does not demonstrate a failure to meet § 51.309(d)(10)(i)(A). This element requires a description of the status of implementation of all control measures included in the regional haze SIP for achieving RPGs for Class I areas both within and outside the State. As discussed in the proposal, New Mexico stated in the progress report that it is implementing all long-term control strategies with the exception of the formerly adopted, and now repealed, State Mobile Source Regulation. The State Mobile Source Regulation, when adopted in 2007, would have applied the California motor vehicle standards within New Mexico. We do not agree that the provided details for § 51.309(d)(10)(i)(A) are lacking or inadequate. Section 51.309(d)(10)(i)(A) requires only a description of the status of the implementation of the measures in the regional haze SIP, not an assessment of the effect of the implementation or failure to implement each specific measure. New Mexico's reliance on the federal program is unlikely to have a significant impact on visibility. At the time the regulation was adopted by New Mexico, the California standards were projected to substantially differ from federal motor vehicle emissions standards. Since that time, as the progress report notes, the California and federal programs for emissions standards for motor vehicles are more aligned with each other than was expected by New Mexico when it adopted the State Mobile Source Regulation.2

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(A) because it was not clear whether certain Western Regional Air Partnership (WRAP) policies, including the WRAP Policy on Enhanced Smoke Management Programs for Visibility and the WRAP Policy on Annual Emissions Goals for Fire, were incorporated into the State's Smoke Management Plan (SMP) and are being implemented.

Response: Consistent with the recommendation of the Grand Canyon Visibility Transport Commission, the regional haze program under 40 CFR part 309 brings special attentiveness to smoke management. New Mexico adopted a revision to the New Mexico Administrative Code (NMAC) addressing smoke management to meet these regional haze rule requirements. The EPA previously approved New Mexico's regional haze SIP in 2012 as meeting the requirements of 40 CFR 51.309(d)(6), which deals with implementation plan requirements related to fire.3 In doing so, the EPA noted that the SMP operating within New Mexico was consistent with the WRAP Policy on Enhanced Smoke Management Programs for Visibility and the Wrap Policy on Annual Emissions Goals for Fire, both of which were appendices to the approved Regional Haze SIP.4 The progress report stated that New Mexico, aside from its update regarding State Mobile Source Regulation, is implementing the long-term strategies adopted into the regional haze SIP. This sufficiently indicates the status of implementation for the State's SMP. Therefore, we disagree that the progress report's discussion of the State's SMP failed to meet the requirements of 40 CFR 51.309(d)(1)(i)(A).

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(B) because it did not include any information about emission reductions provided by the State's SMP. Annual emissions related to fire and estimated benefits should be readily available.

Response: We do not agree with the assertion that the progress report fails to meet the requirements of 40 CFR 51.309(d)(10)(i)(B). While this provision requires a summary of the emission reductions achieved in the State through the implementation of the measures in its regional haze SIP, nothing in this provision requires the State to include estimates in its progress report of the emission reductions achieved by specific measures. Namely, there is no requirement for a detailed, causal analysis that pinpoints or links certain emission reductions to actual regional haze SIP measures. It is acceptable for the State to provide a summary of overall emission changes, rather than an analysis that attributes particular emission reductions from specific sources to certain measures in the plan, mainly when such a higher level summary does not indicate any problem with the direction and magnitude of these overall changes. We address in the response to a later comment the adequacy of the State's summary of overall emissions.

Additionally, the comment misperceives the basis for inclusion of the SMP in the SIP. The visibility goal announced in section 169A of the CAA is both to prevent future impairment as well as remedy existing impairment. Regional haze SIPs accordingly may include programs to avert increases in emissions. The SMP is generally designed to limit increases in emissions, rather than to reduce existing emissions. As such, there would be little purpose for the State to try to estimate the specific emission reductions achieved through implementation of the program.5

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(B) because there were no estimates of reductions by the new source review (NSR) and prevention of significant deterioration (PSD) programs. The progress report did not indicate what emissions were avoided or allowed by the implementation of these programs.

Response: As explained above, nothing in 40 CFR 51.309(d)(10)(i)(B) requires the State to include estimates in its progress report of the emission reductions achieved by specific measures included in the regional haze SIP.

Additionally, although the regional haze SIP also cited the PSD and NSR programs, the primary benefit from these programs is to limit emission increases rather than precisely working to achieve reductions in existing emissions. Given this, there would be little purpose for New Mexico to try to estimate the specific emission reductions achieved through the implementation of these programs.

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(B) because point source data for sources reporting to the Clean Air Markets Database should be included.

Response: This comment does not identify a basis to disapprove the SIP revision. Source-specific information on all electric generating units (the sources reporting to the Clean Air Markets Database) is not required in summarizing the emission reductions in the progress report. The submitted progress report provided detailed information on anticipated emission reductions at the San Juan Generating Station (SJGS). This facility is the largest point source in the State and the most significant New Mexico emission source in the Clean Air Markets Database. More importantly, it is the only electric generating unit with definite emission limits in the New Mexico regional haze SIP. The progress report provided statewide point source emission data from 2008-2012 and compared it to the 2018 projected emission levels.6 While additional information from the Clean Air Markets Database regarding emissions from other electric generating units may be useful, it is not essential for the approval of the submitted progress report. As noted in the proposal, we compared the point source data in the progress report to that reported by the Clean Air Markets Database and found that the reported emissions were consistent with that data.

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(B) because the inventories did not address all haze-related pollutants. Emission inventories specific to particulate organic matter, coarse mass, ammonia (NH3), and volatile organic compounds (VOCs) should be included.

Response: 40 CFR 51.309(d)(10)(i)(B) requires a summary of the emission reductions achieved throughout the State through implementation of the control measures mentioned in 40 CFR 51.309(d)(10)(i)(A). Because this provision does not call for a summary of all pollutants that could contribute to visibility impairment, we do not agree that the progress report is inadequate. The initial regional haze SIP focused on reducing emissions of sulfur dioxide (SO2), nitrogen oxides (NOX), and particulate matter (PM) emissions, and New Mexico's progress report summarized the changes in emissions in these pollutants from 2008-2012. Even if no information on other pollutants was included in the progress report, we would consider it reasonable and sufficient if New Mexico's progress report only provided a summary of emission reductions for these pollutants.

New Mexico's progress report, however, also provided information on other visibility-impairing pollutants. Section 3.5 of the progress report discussed New Mexico's baseline emissions inventory for 2002 and an estimated emissions inventory for 2008. The 2002 inventory was developed by the WRAP for use in the initial WRAP regional haze SIP strategy development. The 2008 inventory was based on WRAP inventory work for the West-wide Jumpstart Air Quality Modeling Study (WestJumpAQMS) and the Deterministic & Empirical Assessment of Smoke's Contribution to Ozone (DEASCO3) modeling project efforts. The pollutants inventoried were SO2, NOX, NH3, VOCs, primary organic aerosol (POA), elemental carbon (EC), fine soil, and coarse mass. The inventories were categorized for all major visibility-impairing pollutants under major source groupings either as anthropogenic or natural. The anthropogenic source categorization included point and area sources, on and off-road mobile sources, area oil and gas, fugitive and road dust, and anthropogenic fire. The natural source categorization included natural fire, wind-blown dust, and biogenic sources.

Comment: The progress report presented information on visibility levels within section 3.3 of the progress report, which is titled as addressing the requirement of 40 CFR 51.309(d)(10)(i)(B). The commenter does not consider this presentation as satisfying the requirement of 40 CFR 51.309(d)(10)(i)(B) concerning emissions because the progress report failed to explain how much of the monitored improvements in visibility impairment were the result of emission reductions from control measures in the New Mexico SIP or from factors outside of the SIP. Furthermore, the trends outlined in section 3.5 were seven years out of date.

Response: We agree with the commenter that information on visibility levels is not an adequate substitute for the summary of emissions that is specifically required by § 51.309(d)(10)(i)(B). However, we are not basing our approval of the progress report as meeting the requirements of 40 CFR 51.309(d)(10)(i)(B) on the information on visibility levels presented in section 3.3 of the progress report. The summary of emissions requirement is satisfied for the reasons explained in our earlier responses.

Comment: The goal of the progress report is to document progress and changes over the past five years and to make informed decisions on that basis. To meet the requirements of 40 CFR 51.309(d)(10)(i)(C), the progress report should include information that describes the preceding five-year period as closely as possible. The progress report discussed the 2005-2009 period. Although information from 2007-2011 was included, the EPA should require the use of the most recent data available.

Response: Although New Mexico used 2005-2009 data to estimate current conditions, it also included additional IMPROVE data in its progress report. The 2007-2011 visibility information was specifically included in Tables 3.3-3.18 of the progress report. We do not agree that the information was not addressed such that the requirements of the section were not met. Because the progress report was not submitted until March 14, 2014, however, there was an understandable lag between its drafting, its adoption, and submission. We do not consider the non-inclusion of visibility data more recent than 2011 to be a basis for disapproval. Visibility data for all Class I areas through 2013 were available to the public as of the date of the commenter's letter via the IMPROVE program's Web site, and the commenter did not argue that the more recent data supports disapproval of the progress report.

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(D) because it did not use the most up-to-date emissions information nor provide sufficient forward projections.

Response: Section 3.8 of the progress report contains a detailed analysis of 2008 emissions from all source types. In addition, Figure 3.6 of the SIP revision presents SO2 and NOX point source emission data for 2008-2012. The year 2012 was the most recent emission information covering all types of point sources available at the time of the progress report's development. The progress report does not include any emissions information for non-point sources for any year more recent than 2008. However, we note that the 2011 National Emissions Inventory (NEI) Version 1.01 was published by the EPA in July 2013,7 only about 8 months before the State submitted the progress report. In light of this, we consider the progress report to adequately meet the requirement of 40 CFR 51.309(d)(10)(i)(D), which calls for an analysis tracking the changes “over the past 5 years” in emissions from “all sources” based on “the most recent updated emissions inventory.”

Regarding the issue of projected inventories, § 51.309(d)(10)(i)(D) states that emission estimates must be projected forward as necessary and appropriate to account for emissions changes during “the applicable 5-year period.” This phrase is meant to refer to “the past 5 years,” a phrase that itself is not clearly defined in the rule. The progress report was required to be submitted in 2013 and was submitted in February 2014. Thus, a projection for point sources would at most have included estimates for 2013. In light of this, we do not believe that a projection for point sources beyond 2012 is necessary. With regard to non-point sources, a projection could have addressed projected-emissions several years beyond the 2008 information presented in the progress report; however, the SIP focuses primarily on the control of point source emissions. With respect to changes in fire-related emissions, projections would inherently be highly uncertain in any case. Consequently, we do not believe that projections of non-point source emissions beyond 2008 were needed in the progress report.

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(E) because it drew an unsupported conclusion that no anthropogenic emissions within New Mexico limited or impeded progress in reducing pollutant emissions or improving visibility. For example, White Mountain had visibility degradation.

Response: We disagree with the comment. 40 CFR 51.309(d)(10)(i)(E) requires an assessment of any significant changes in anthropogenic emissions within or outside the State that have occurred over the past five years that have limited or impeded progress in reducing pollutant emissions and improving visibility in Class I areas impacted by the State's sources. In its progress report, New Mexico concluded that no such changes had occurred. The proposal noted that there have been significant reductions in emissions of SO2 and NOX from point sources within the State. Also, the State has relied on the history of visibility levels at affected Class I areas to assess whether there have been changes in emissions that limit or impede progress. While we do not consider information on visibility levels to be a substitute for the required summary of emissions that is exactly required by § 51.309(d)(10)(i)(B), we consider this approach to be an acceptable method for making the assessment of whether there have been changes in emissions that limit or impede progress. Overall visibility at each of the seven Class I areas in New Mexico had improved since the baseline period, with the exception of visibility at the White Mountain Wilderness Area for the most recent period. Specifically, for White Mountain, the five-year average deciview trend for the 2007-2011 period showed slightly worse visibility (0.2 dv higher) for the 20% worst days, as compared to average conditions for 2000-2004. The commenter relied on this degradation in visibility at White Mountain to support its argument that anthropogenic emissions within New Mexico have limited progress in improving visibility. The slight visibility degradation at White Mountain, however, was the result of elevated coarse mass levels from non-anthropogenic sources in 2011 compared to baseline levels.8 Overall SO2 and NOX emissions in New Mexico have actually been going down, or are at least stable. The proposal also indicated that White Mountain showed a 0.3 dv improvement in visibility on the 20% best days.9

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(E) because it failed to address anthropogenic emissions outside of New Mexico that may have limited or impeded progress in visibility improvement.

Response: The progress report is required to assess significant changes outside the State that have limited or impeded progress, as specified by § 51.309(d)(10)(i)(E). As in the case of assessing in-state emissions, we believe it was acceptable for the State to use trends in visibility levels to make this assessment. Visibility conditions at the Class I areas are improving, as discussed in response to the comment above, and there do not appear to be significant changes that would call for explicit discussion. We also note that the State's Regional Haze SIP and its participation in the section 309 program addressed anthropogenic emissions from outside of the borders that limit or impede visibility improvement.

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(F) because it cited 2000-2010 visibility monitoring data to conclude that New Mexico's approach was sufficient to meet the RPGs. The progress report offers little support to show that visibility is causally linked to New Mexico's SIP measures rather than to changes in natural or out-of-state sources. The EPA should require quantitative evidence to show the link between visibility benefits and the SIP measures.

Response: We view the requirement of this section as a qualitative assessment that should evaluate emissions and visibility trends, including expected emission reductions from measures that have not yet become effective. Even though section 3.7 of the progress report (titled as addressing the requirement of 40 CFR 51.309(d)(10)(i)(F)) cited visibility monitoring data from 2000-2010, visibility data through 2011 is presented in other sections of the progress report. In particular, tables 3.3-3.18 presented visibility values of the 20% worst and 20% best days of periods 2000-2004, 2005-2009, 2006-2010, and 2001-2011 for each affected Class I area. Table 2.1 of the progress report showed the RPGs for each area.

The five-year average deciview values for the most recent period 2007-2011 indicated visibility improvement for all Class I areas (relative to 2000-2004 baseline period) except White Mountain, which was slightly worse by 0.2 dv. It is important to note that White Mountain visibility improved in the 2005-2009 and 2006-2010 periods compared to the baseline period 2000-2004. The data supports the conclusion that the 2007-2011 visibility conditions at White Mountain were higher than the 2000-2004 baseline due to elevated coarse mass levels in 2011 from high wind events.

The 2007-2011 visibility conditions at Bandelier and San Pedro parks were higher than in the intermediate periods, due to elevated particulate organic matter levels in 2011 from impacts of fires, but better than in 2000-2004.

For all the areas, the 2007-2011 visibility levels were better than the RPGs for the 20% best days. This is also true for five of the areas for the 20% worst days. The commenter did not suggest any particular reasons to expect that visibility will degrade in these areas for the best/worst days where it is already better than the 2018 RPGs.

As noted, three Class I sites were not yet meeting the 2018 RPGs for the 20% worst days in 2007-2011. The progress report explains that in this period White Mountain was adversely affected by coarse mass from high wind events, and San Pedro and Bandelier were affected by particulate organic matter from natural and anthropogenic fires. In 2005-2009, these three areas were below or very close to the 2018 RPGs.

In summary, we conclude that the State's visibility assessment is adequate. Wildfires or dust storms might again affect visibility in the 2018 timeframe, but New Mexico expects further reduction of SO2 and NO2 emissions, principally from the implementation of Best Available Retrofit Technology (BART) controls. These control measures should contribute toward improved visibility conditions at all New Mexico Class I areas, including Bandelier, San Pedro, and White Mountain for 2018. Further progress will also occur through recently adopted or proposed regulatory programs. The State was reasonable to rest on these positive overall visibility trends and future expectations regarding emission reductions in determining that the existing SIP requires no further revision to achieve established RPGs. New Mexico demonstrated progress toward meeting the RPGs and no substantive revisions to the Regional Haze SIP are necessary for the first planning period. We also note that § 51.309(d)(10)(i)(F) does not impose a requirement for a demonstration of a causal linkage between improvements in visibility and measures in New Mexico's SIP.

Comment: The progress report does not meet 40 CFR 51.309(d)(10)(i)(F) because it did not offer sufficient evaluation of the lack-of-progress or backsliding at Class I areas, like White Mountain, that indicated degradation in the 2007-2011 time-period relative to 2005-2009 values. A more detailed account of visibility issues at these Class I areas should be required before concluding that the existing SIP is adequate.

Response: We disagree with this comment. Based on the speciation information in Tables 3.3-3.18, the data supports the conclusion that dust storms and/or wildfires are responsible for the limited cases of degradation in visibility between 2005-2009 and 2007-2011, rather than any backsliding on the control of emissions from anthropogenic sources.

Comment: According to 40 CFR 51.308(d)(1)(B)(vi), RPGs should reflect all reductions in the SIP and in any other CAA requirement. RPGs for Class I areas impacted by SJGS should be lower. The EPA should require the progress report to include a list of Class I areas impacted by future reductions from SJGS and clarify that RPGs are those that would be consistent with that source's reductions.

Response: The progress report was prepared with emphasis on New Mexico's improvement in meeting established RPGs for 2018. There were no changes to the State's RPGs in the progress report nor were there any submitted for review as any separate SIP revision. Whether the RPGs should be lower is not in the scope of the proposed action. We agree that future reductions at SJGS will improve visibility at Class I areas inside and outside of New Mexico. Having already approved the RPGs,10 we noted that with the additional future two-unit shut down and two-unit selective non-catalytic reduction (SNCR) installation at the SJGS, New Mexico emissions will improve on the RPGs in its SIP. New Mexico is not impeding other states in meeting analogous RPGs, and the additional BART controls will decrease visibility-impairing pollutants more than anticipated from the RPGs based on the WRAP modeling for NOX, SO2 and PM.

New Mexico does not have a progress report requirement to list all Class I areas impacted by future reductions from the SJGS. However, state and federal technical records for the BART determination at SJGS provide information on this area of interest.

Comment: The commenter requested that the EPA require revisions to the progress report to ensure Class I areas in New Mexico and surrounding states are on the glide path to achieve natural visibility conditions by 2064.

Response: In the progress report SIP, New Mexico was required to assess whether the SIP was sufficient to meet the RPGs that were established for the first ten-year planning period. There is no requirement for a state to include an assessment of whether a SIP is sufficient to ensure that Class I areas (in the State or those in nearby states) are on track to meet the uniform rate of progress (URP).11 The State followed the proper approach in setting the RPGs through 2018 by considering the URP and the factors established in section 169A of the CAA and in the EPA's Regional Haze Rule at 40 CFR 51.308(d)(1)(i)(A). In doing so, the RPGs reflected a slower rate of progress than the URP for the first planning period. Those established RPGs for each Class I area in New Mexico were approved by the EPA in a previous action.12 Looking forward, New Mexico will be required to provide new updated RPGs for 2028 in the next comprehensive regional haze SIP revision planning period.

The EPA is approving New Mexico's regional haze progress report SIP revision (submitted on March 11, 2014) as meeting the applicable regional haze requirements set forth in 40 CFR 51.309(d)(10).13 The EPA is also approving New Mexico's determination that the current regional haze SIP requires no further substantive revision at this time in order to achieve established RPGs for 2018 for visibility improvement and emission reductions.

40 CFR 51.309(d)(10)(i)(A) requires a description of the status of implementation of all control measures included in the regional haze SIP for achieving RPGs for Class I areas both within and outside the State. New Mexico adequately addressed the status of control measures in the progress report regional haze SIP as required by the provisions under 40 CFR 51.309(d)(10)(i)(A). All major control measures (including BART) were identified and the emission reduction strategy behind each control was explained. New Mexico included a summary of the implementation status associated with each control measure and quantified the benefits where possible. In addition, the progress report SIP adequately outlined the compliance time-frame for all controls.

40 CFR 51.309(d)(10)(i)(B) requires a summary of the emission reductions achieved throughout the State through implementation of control measures mentioned in 40 CFR 51.309(d)(10)(i)(A). The progress report must identify and estimate emission reductions to date in visibility-impairing pollutants from the SIP control measures identified for implementation. New Mexico has adequately summarized the emission reductions achieved throughout the State in the progress report regional haze SIP as required under 40 CFR 51.309(d)(10)(i)(B).

40 CFR 51.309(d)(10)(i)(C) requires that for each mandatory Class I Federal area within the State, the State must assess visibility conditions and changes, with values for most impaired and least impaired days expressed in terms of five-year averages of these annual values. New Mexico has adequately addressed the requirements under 40 CFR 51.309(d)(10)(i)(C) to include summaries of monitored visibility data as required by the Regional Haze Rule.14

40 CFR 51.309(d)(10)(i)(D) requires an analysis tracking the change over the past five years in emissions of pollutants contributing to visibility impairment from all sources and activities within the State. The analysis must be based on the most recent updated emissions inventory, with estimates projected forward as necessary and appropriate, to account for emissions changes during the applicable five-year period. New Mexico has adequately addressed the requirements under 40 CFR 51.309(d)(10)(i)(D) to track changes in emissions of pollutants contributing to visibility impairment from all sources and activities within the State. The analysis in the progress report was based on appropriate data.

40 CFR 51.309(d)(10)(i)(E) requires an assessment of any significant changes in anthropogenic emissions within or outside the State that have occurred over the past five years that have limited or impeded progress in reducing pollutant emissions and improving visibility in Class I areas impacted by the State's sources. New Mexico has adequately addressed the requirements under 40 CFR 51.309(d)(10)(i)(E) to show that the major contributors of anthropogenic emissions are being reduced and visibility is improving without having limited or impeded progress.

40 CFR 51.309(d)(10)(i)(F) calls for an assessment of whether the current implementation plan elements and strategies in the regional haze SIP are sufficient to enable the State, or other states with mandatory Federal Class I areas affected by emissions from the State, to meet all established RPGs. New Mexico has adequately addressed the requirements under 40 CFR 51.309(d)(10)(i)(F). New Mexico referenced the improving visibility trends with appropriately supported data with a focus on future implementation of BART controls.

40 CFR 51.309(10)(i)(G) requires a review of the State's visibility monitoring strategy and any modifications to the strategy as necessary. New Mexico has adequately addressed the sufficiency of the monitoring strategy as required by the provisions under 40 CFR 51.309(d)(10)(i)(G). New Mexico reaffirmed the continued reliance upon the IMPROVE monitoring network. New Mexico also explained the importance of the IMPROVE monitoring network for tracking visibility trends at the Class I areas and identified no expected changes in this network.

Under 40 CFR 51.309(d)(10)(ii), states are required to submit, at the same time as the progress report SIP, a determination of the adequacy of the existing regional haze SIP and take one of four possible actions based on information in the progress report. New Mexico stated in the progress report SIP that the current Section 309 and 309(g) regional haze SIPs are adequate to meet the State's 2018 RPGs and require no further revision at this time. The EPA is approving this negative declaration from New Mexico.

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

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

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

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

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

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

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

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

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this rulemaking does not involve technical standards; and

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 14, 2017. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce the requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

This final rule applies to those facilities, referred to as “stationary sources” under the Clean Air Act (CAA), that are subject to the chemical accident prevention requirements at 40 CFR part 68. This includes stationary sources holding more than a threshold quantity (TQ) of a regulated substance in a process. Table 5 provides industrial sectors and the associated NAICS codes for entities potentially affected by this action. The Agency's goal is to provide a guide for readers to consider regarding entities that potentially could be affected by this action. However, this action may affect other entities not listed in this table. If you have questions regarding the applicability of this action to a particular entity, consult the person(s) listed in the introductory section of this action under the heading entitled FOR FURTHER INFORMATION CONTACT.

This final action and pertinent documents are located in the docket (see Addresses section). In addition to being available in the docket, an electronic copy of this document and the response to comments document will also be available at https://www.epa.gov/rmp/final-amendments-risk-management-program-rmp-rule.

Under CAA section 307(b)(1), judicial review of this final rule is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit (the Court) by August 14, 2017. Under CAA section 307(d)(7)(B), only an objection to this final rule that was raised with reasonable specificity during the period for public comment can be raised during judicial review.

On January 13, 2017, the EPA issued a final rule amending 40 CFR part 68, the chemical accident prevention provisions under section 112(r)(7) of the CAA (42 U.S.C. 7412(r)). The amendments addressed various aspects of risk management programs, including prevention programs at stationary sources, emergency response preparedness requirements, information availability, and various other changes to streamline, clarify, and otherwise technically correct the underlying rules. Collectively, this rulemaking is known as the “Risk Management Program Amendments.” For further information on the Risk Management Program Amendments, see 82 FR 4594 (January 13, 2017).

On January 26, 2017, the EPA published a final rule delaying the effective date of the Risk Management Program Amendments from March 14, 2017, to March 21, 2017, see 82 FR 8499. This revision to the effective date of the Risk Management Program Amendments was part of an EPA final rule implementing a memorandum dated January 20, 2017, from the Assistant to the President and Chief of Staff, entitled “Regulatory Freeze Pending Review.” This memorandum directed the heads of agencies to postpone until 60 days after the date of its issuance the effective date of rules that were published prior to January 20, 2017 but which had not yet become effective.

In a letter dated February 28, 2017, a group known as the “RMP Coalition,” 1 submitted a petition for reconsideration of the Risk Management Program Amendments (“RMP Coalition Petition”) as provided for in CAA section 307(d)(7)(B) (42 U.S.C. 7607(d)(7)(B)).2 On March 13, 2017, the Chemical Safety Advocacy Group (“CSAG”) also submitted a petition for reconsideration and stay.3 On March 14, 2017, the EPA received a third petition for reconsideration and stay from the State of Louisiana, joined by Arizona, Arkansas, Florida, Kansas, Kentucky, Oklahoma, South Carolina, Texas, Wisconsin, and West Virginia. The petitions from CSAG and the eleven states also requested that EPA delay the various compliance dates of the Risk Management Program Amendments.

Under CAA section 307(d)(7)(B), the Administrator may commence a reconsideration proceeding if, in the Administrator's judgement, the petitioner raises an objection to a rule that was impracticable to raise during the comment period or if the grounds for the objection arose after the comment period but within the period for judicial review. In either case, the Administrator must also conclude that the objection is of central relevance to the outcome of the rule. The Administrator may stay the effective date of the rule for up to three months during such reconsideration.

In a letter dated March 13, 2017, the Administrator announced the convening of a proceeding for reconsideration of the Risk Management Program Amendments (a copy of “the Administrator's Letter” is included in the docket for this rule, Docket ID No. EPA-HQ-OEM-2015-0725).4 As explained in the Administrator's Letter, having considered the objections raised in the RMP Coalition Petition, the Administrator determined that the criteria for reconsideration have been met for at least one of the objections. EPA issued a three-month (90-day) administrative stay of the Risk Management Program Amendments, which delayed the effective date of the Risk Management Program Amendments rule for 90 days, from March 21, 2017 until June 19, 2017 (see 82 FR 13968, March 16, 2017). EPA will prepare a notice of proposed rulemaking in the near future that will provide the RMP Coalition, CSAG, the states, and the public an opportunity to comment on the issues raised in the petitions that meet the standard of CAA section 307(d)(7)(B), as well as any other matter we believe will benefit from additional comment.

The Administrator's authority to administratively stay the effectiveness of a CAA rule pending reconsideration (without a notice and comment rulemaking) is limited to three months (see CAA section 307(d)(7)(B)) EPA believed that three months was insufficient to complete the necessary steps in the reconsideration process for the Risk Management Program Amendments and to consider other issues that may benefit from additional comment.5 Since we expect to take comment on a broad range of legal and policy issues as part of the Risk Management Program Amendments reconsideration, on April 3, 2017 (82 FR 16146), we proposed to further delay the effective date of the Risk Management Program Amendments to February 19, 2019.

The statutory authority for this action is provided by section 307(d) of the CAA, as amended (42 U.S.C. 7607(d)), which generally allows the EPA to set effective dates as appropriate unless other provisions of the CAA control, and section 112(r)(7) of the CAA (see section IV.A below).

EPA received a total of 54,117 public comments on the proposed rulemaking. Several public comments were the result of various mass mail campaigns and contained numerous copies of letters or petition signatures. Approximately 54,000 letters and signatures were contained in these several comments. The remaining comments include 108 submissions with unique content (including representative copies of form letter campaigns and joint submissions), and nine duplicate submissions. EPA also held a public hearing on April 19, 2017 where EPA received five written comments and 28 members of the public provided verbal comments (three of the speakers later submitted their testimony as written comments). Comments received during the public hearing are included in the 107 submissions with unique content. A transcript of the hearing testimony is available as a support document in the docket EPA-HQ-OEM-2015-0725 for this rulemaking. A summary of public comments and EPA's response to the comments can be found in the Response to Comments document, also available in the docket. 6

In the proposed rulemaking, EPA noted that under CAA section 307(d), the Agency may set effective dates as appropriate through notice and comment rulemaking unless another provision of the CAA controls. In the past, EPA has used this authority in conjunction with the reconsideration process when the administrative stay period of three months, which the Administrator may invoke without notice and comment, would be insufficient to complete the necessary process for reconsideration.

Several industry trade associations agreed that EPA had authority under CAA section 307(d) to conduct a notice and comment rulemaking delaying the effective date for this rulemaking. Some noted that, unlike other CAA provisions, there are no provisions in CAA section 112(r)(7) requiring a specific, earlier effective date. Some pointed out that, in contrast to several other CAA provisions (see, e.g., CAA section 112(e)(1), CAA section 112(i)(3)(A), and CAA section 112(j)(5)), CAA section 112(r)(7)(A) gives the Administrator the flexibility to make a rule effective with no specific outside date beyond that which “assur[es] compliance as expeditiously as practicable.” In light of EPA's commitment to take further regulatory action in the near future, with the potential for a broad range of rule revisions (82 FR 16148 through 16149, April 3, 2017), and the substantial resources required to prepare for compliance mentioned in the final Risk Management Program Amendments (82 FR 4676, January 13, 2017), these commenters agreed that the 20-month delay in the effective date would be as expeditiously as practicable. Several of these commenters also identified 5 U.S.C. 705 in the Administrative Procedure Act as a potential vehicle for postponing the effective date indefinitely in connection with the pending litigation.

Other commenters contested EPA's authority to delay the effective date as proposed. A group of advocacy organizations, as well as a legal institute affiliated with a law school, argued that the 90-day stay provision in CAA section 307(d)(7)(B) is the maximum period that a rule can be stayed or have its effectiveness delayed in connection with a reconsideration. Noting that, except for the 90-day stay provision, the subparagraph provides that “reconsideration shall not postpone the effectiveness of the rule,” one commenter contends no additional exceptions can be implied. The commenter supports its position by citing Natural Resources Defense Council v. Reilly, 976 F.2d 36, 40-41 (D.C. Cir. 1992). Another commenter argues that EPA had “no excuse” for not seeking comment on its first two delays of effectiveness, making further delay impermissible.

More generally, commenters opposed to the proposed delay of effectiveness sought to rely on previous findings in the rulemaking record for the Risk Management Program Amendments. Noting that CAA section 112(r)(7)(B) provides that the regulations under that paragraph should provide for the prevention and detection of, and the response to, accidental releases “to the greatest extent practicable,” one commenter argues that a 20-month delay in effectiveness would run counter to the statute when EPA in the Risk Management Program Amendments already determined it was practicable to implement these regulations sooner. The commenter notes that paragraph (B) of CAA section 112(r)(7) requires rules to be applicable to a stationary source no later than three years after promulgation, so extending the effective date 20 months would “inevitably result in pushing some or all of the compliance deadlines far beyond three years.” The commenter viewed EPA as needing a more complete justification than if it were setting “a new policy created on a blank slate.” According to the commenter, EPA failed to justify its changed position. In the view of the commenter, EPA's discussion of compliance dates for new provisions in the Risk Management Program Amendments final rule (82 FR 4675-80, January 13, 2017) demonstrates that the 20-month delay in effectiveness does not comply with “as expeditiously as practicable” under CAA section 112(r)(7)(A).

Commenters also dispute the basis for convening a reconsideration proceeding by criticizing the BATF West finding itself and whether its publication two days before the close of comments made it impracticable to comment on the report. One commenter noted several of the parties requesting reconsideration in fact mentioned the BATF West finding in their comments. Another commenter objected to EPA not specifying what other issues met the reconsideration standard. More generally, commenters opposed to the delay of effectiveness found EPA lacked sufficient detail in its explanation of the basis for proposing to delay effectiveness of the Risk Management Program Amendments for them to be able to comment. Commenters further asserted that a further delay makes it more likely that another incident like the West Fertilizer explosion and other events discussed in the record, will occur. Commenters also expressed a concern that EPA could repeatedly delay the effective date based on the logic in the proposed rule.

Response: EPA notes that CAA section 112(r)(7)(A) does not contain any language limiting “as expeditiously as practicable” to an outside date (e.g., “in no case later than date X”). The volume of comments received on the proposed rule validates our expectation that there will be a high level of interest in the broad range of issues we expect to take comment on. For example, in this rulemaking, several commenters have criticized the methodology of the BATF West finding and raised substantive concerns about various rule provisions. We have consistently stated that, beyond those issues that meet the CAA section 307(d)(7)(B) standard for reconsideration, we intend to raise other matters that we believe would benefit from additional comment (see, the Administrator's Letter).7 Many of the decisions underlying the Risk Management Program Amendments are policy preferences based on weighing factors in the record that could be rationally assessed in different ways. We continue to believe that evaluating these issues will be difficult and time consuming. A delay of effectiveness will allow EPA time for a comprehensive review of objections to the Risk Management Program Amendments rule without imposing the rule's substantial compliance and implementation resource burden when the outcome of the review is pending.

A delay of 20 months is a reasonable length of time to engage in the process of revisiting issues in the underlying Risk Management Program Amendments. Contrary to some commenters assertions (and contrary to the urging of those commenters who asked that we invoke the Administrative Procedure Act (APA) section 705), we did not propose and are not finalizing an indefinite delay of effectiveness. During this period, the pre-Amendments 40 CFR part 68 rules will remain in effect. As we noted when we proposed and finalized the Risk Management Program Amendments, “[t]he [Risk Management Program] regulations have been effective in preventing and mitigating chemical accidents in the United States” (see 82 FR 4595, January 13, 2017). We discuss additional bases for the delay of effectiveness for 20 months in section V of the preamble. For all of these reasons, we conclude that the delay of effectiveness for 20 months is as expeditious as practicable for allowing the rule to go into effect.

We disagree with the view that the three month stay provision in CAA section 307(d)(7)(B) prohibits the use of rulemaking to further delay the effectiveness of rules that are not in effect. As an initial matter, were no reconsideration involved, a rule with a future effective date could have its effective date delayed simply by a timely rulemaking amending its effective date before the original date. Cf. NRDC v. EPA, 683 F.2d 752, 764 (3d Cir. 1982) (discussing application of rulemaking procedures to action to postpone effective date of rule); NRDC v. Abraham, 355 F.3d 179, 203 (2d Cir. 2004) (discussing amendment of effective date of rule through notice-and-comment process). While one commenter criticizes the initial delay of effectiveness for relying on the good cause exception (arguing that, in lieu of the initial good cause delay, we should have used a notice and comment procedure to delay the effective date), and the subsequent 90-day stay for continuing that delay, neither of those actions were challenged. There is no reasonable dispute that the Risk Management Program Amendments are not yet in effect. EPA has explained in both the proposed rule and in the Administrator's Letter of March 13, 2017,8 that part of its purpose in proposing to delay the effective date 20 months is to not only to conduct a reconsideration on the issues identified in that letter but also to solicit comment on any other matter that will benefit from additional comment. The interpretation of CAA section 307(d)(7)(B) urged by the commenters would say that EPA's ability to use a notice and comment procedure to delay the effective date for these matters that EPA seeks to solicit additional comment on is negated when there is a reconsideration ongoing as well.

We also disagree with the commenters' view that the phrase “reconsideration shall not postpone the effective date of the rule” is meant to prohibit using a notice and comment procedure or any means other than the three month stay in CAA section 307(d)(7)(B) to delay a rule that is not in effect. In quoting the statute, the comment omits the word “[s]uch.” In context, “such reconsideration” follows a discussion of the process for convening reconsideration and precedes the three month stay provision. A natural reading of the language is that the act of convening reconsideration does not, by itself, stay a rule but that the Administrator, at his discretion, may issue a stay if he has convened a proceeding. The three-month limitation on stays issued without rulemaking under CAA section 307(d)(7)(B) does not limit the availability or length of stays issued through other mechanisms. Furthermore, CAA section 307(d) expressly contemplates the “revision” of rules to which it applies. See CAA section 307(d)(1); see also CAA section 112(r)(7)(E) (regulations under CAA section 112(r) “shall for purposes of sections 113 . . . and 307 . . . be treated as a standard in effect under subsection (d) of [section 112]”). EPA is issuing this rule as a revision of the Risk Management Program Amendments.

The case of Natural Resources Defense Council v. Reilly, 976 F.2d 36 (D.C. Cir. 1992) (NRDC) does not prohibit EPA from using rulemaking procedures under CAA section 307(d) to modify and delay the effective date of the Risk Management Program Amendments. In that case, EPA had made the finding that radionuclides were hazardous air pollutants under the pre-1990 CAA. That finding, in turn, triggered a series of mandatory duties under the CAA that required promulgation of emission standards. EPA did so after several court orders but, under a series of rules under CAA section 301 and the pre-1990 CAA section 112, continuously stayed the effectiveness of those rules. The 1990 Amendments added special provisions for radionuclides, saving the former rules, delaying the effectiveness of a category of rules impacting medical facilities regulated by the Nuclear Regulatory Commission (NRC), and establishing specific procedures for exempting NRC-licensed sources. See CAA section 112(d)(9), CAA section 112(q). EPA conducted a rulemaking under CAA section 112(d)(9) but lacked sufficient data to promulgate an exemption for most NRC-licensed facilities. Nevertheless, EPA promulgated a stay of effectiveness of the radionuclide rules, using CAA section 301, while it gathered the necessary information to establish exemptions. (See NRDC at 38-39.) EPA characterized its rule as a transitional rule necessary to implement the intent of the 1990 Amendments. Id. at 40.

The NRDC court observed that the pre-1990 CAA had a highly circumscribed schedule for promulgating hazardous air pollutant rules. NRDC at 41. Recognizing that its past precedents did not allow the grant of general rulemaking authority to override specific provisions of the CAA, the court held that “[i]n the face of such a clear statutory command, we cannot conclude that section 301 provided the EPA with the authority to stay regulations that were subject to the deadlines established by [former] section 112(b).” Id.

In contrast to the “clear statutory command” to promulgate rules for radionuclides once they were found to be hazardous air pollutants, CAA section 112(r) contains no similar mandate to promulgate the Risk Management Program Amendments. There is no dispute that EPA discharged its mandatory duty under CAA section 112(r)(7)(B) to promulgate “reasonable regulations” when it promulgated the Risk Management Program rule in 1996. These rules have been in effect and stationary sources that have present a threshold quantity of a regulated substance must comply with 40 CFR part 68 as in effect. The Risk Management Program Amendments were not promulgated to comply with a court order enforcing a mandatory duty. In contrast to the specific deadlines in the pre-1990 CAA for hazardous air pollutant regulation and the detailed structure in CAA section 112(d)(9) and CAA section 112(q) for addressing radionuclides under the amended CAA, CAA section 112(r)(7)(A) provides the Administrator substantial discretion regarding the setting of an effective date. The statutory framework for a discretionary rule under CAA section 112(r)(7) differs greatly from the “highly circumscribed schedule” analyzed by the NRDC court. Absent an otherwise controlling provision of the CAA, CAA section 307(d) allows EPA to set a reasonable effective date.

We view the provision in CAA section 112(r)(7)(B) regarding when regulations shall be “applicable” to a stationary source to not prohibit the delay of effectiveness we promulgate in this rule. First, we note that February 2019 is before January 2020 (three years after the January 2017 promulgation), so even assuming the provision in question requires compliance by three years after promulgation of the Risk Management Program Amendments,9 it is speculative to say that it is “inevitable” that some compliance dates will be “pushed off far beyond three years” from promulgation. Even if the commenter's intuition is correct, the argument is premature. A challenge to compliance dates after January 2020 should be brought in litigation over a rule that establishes such a date. Second, the appropriate rule to challenge compliance dates set in the Risk Management Program Amendments would be the underlying rule (i.e., the Risk Management Program Amendments rule promulgated on January 13, 2017) that established compliance dates. This rule does not impact compliance dates except for those dates that would be triggered prior to February 2019. If EPA proposes amending compliance dates beyond January 13, 2020, then this issue will need to be addressed.

While CAA section 112(r)(7)(B) contains a requirement that EPA's regulations “provide, to the greatest extent practicable,” for prevention, detection, and response to accidental releases, that subparagraph places this requirement in the context of a mandate for the regulations to be “reasonable.” The phrase “to the greatest extent practicable” does not prohibit weighing the difficulties of compliance planning and other implementation issues.

This action itself is not the convening of reconsideration, therefore, the questions of whether the arson finding by the BATF was proper are outside the scope of this rule. Even if the comment were within the scope of this rulemaking, the mention of the BATF finding in a few scattered comments does not mean that it was practicable for the public generally and the hundreds of commenters to meaningfully address the significance of the finding for a rule with multiple issues and hundreds of supporting documents. EPA is not taking action under APA section 705 at this time.

Many commenters supported EPA's proposal to delay the effective date of the final rule to February 19, 2019. These commenters included industry associations, regulated facilities, state government agencies, and others. These commenters gave various reasons for delaying the final rule's effective date.

Several commenters indicated the final rule included changes on which the public was never offered an opportunity to comment as required by the CAA. These commenters highlighted a new provision in the final rule requiring regulated facilities to disclose any information relevant to emergency planning to local emergency planners, and a new final rule trigger for third-party audits allowing an implementing agency to require such an audit due to “conditions at the stationary source that could lead to the release of a regulated substance” as issues that warrant reconsideration and delaying the effective date of the final rule. These commenters argued that the public was deprived of effective notice and opportunity to comment on the new provisions.

Response: EPA agrees that the final rule included some rule provisions that may have lacked notice and would benefit from additional comment and response.

Many commenters indicated that the finding by the Bureau of Alcohol, Tobacco, and Firearms (BATF) that the West Fertilizer explosion was caused by arson undermined the basis for the rule and that this necessitates delaying the final rule's effective date, in order to reconsider its provisions, in light of the BATF finding. Some complained the timing of BATF's announcement a few days before the end of the rule comment period precluded the development and submission of meaningful comments addressing this change in circumstances and its implications.

Response: EPA agrees that the timing of the BATF finding on the West Fertilizer incident made it impracticable for many commenters to meaningfully address the significance of this finding in their comments on the rule. Additionally, delaying the effective date of the final rule to February 19, 2019, will give the Agency an opportunity to consider comments on the BATF finding and take further action to reconsider the rule, propose any necessary changes, and provide opportunity for public comment on any changes made.

Many commenters indicated that the effective date of the rule should be delayed because its information disclosure provisions create security risks, and these risks have not been adequately addressed by EPA in the final rule. Other commenters objected to other specific provisions of the final rule (e.g., third-party audits, safer technology and alternatives analysis (STAA), incident investigation requirements, etc.), indicating that EPA had provided no evidence that these provisions would produce the benefits claimed by EPA, and that EPA should delay the effective date of the final rule either to provide such evidence or remedy these deficiencies by making substantive changes to the rule. Numerous commenters argued that EPA failed to show that the benefits of the final rule outweigh its costs and made other flaws in the regulatory impact analysis, which the commenters contended were grounds for delaying the effective date of the final rule and reconsidering its provisions. One trade association stated that the Risk Management Program Amendments are not needed and that the current Risk Management Program has been effective in identifying and reducing risks and preventing offsite impacts based on EPA data showing that between 2004 and 2013 there has been a decrease of over 60% of all RMP-reportable events. Another trade association believes that the amendments raise substantial questions of policy and significantly increase the regulatory burden without corresponding benefits and should be considered for repeal under Executive Orders 13771, “Reducing Regulation and Controlling Regulatory Costs” 10 and 13777, “Enforcing the Regulatory Reform Agenda.” 11

A commenter representing a group of State agencies argued that the effective date should be delayed because the final rule created unjustified burdens on state and local emergency responders. Several commenters indicated that EPA did not adequately coordinate with OSHA during the rulemaking process, and that EPA should delay the effective date of and reconsider the rule in order to coordinate any amendments to the Risk Management Program with changes made by OSHA to its Process Safety Management standard.

Some commenters also argued that the effective date should be delayed because EPA did not adequately address small business concerns, or made other procedural errors during the rulemaking process.

Response: While it is not necessary for EPA to address the substance of these claims in this rulemaking, we note they represent a wide-ranging and complex set of policy and procedural issues. Some of these issues would not meet the standard for reconsideration under CAA section 307(d)(7)(B), but present substantial policy concerns that EPA may wish to address while it conducts the reconsideration process for issues that meet that reconsideration standard. Whether or not EPA agrees with commenters on the merits of these claims, the Agency believes the existence of such a large set of unresolved issues demonstrates the need for careful reconsideration and reexamination of the Risk Management Program Amendments. Therefore, while EPA does not now concede that it should make the particular regulatory changes that these commenters have recommended, or that the Agency made errors in its regulatory impact analysis or rulemaking procedures, EPA concurs with commenters to the extent that they argue for finalizing the proposed delay in the effective date of the Risk Management Program Amendments rule in order to conduct a reconsideration proceeding. That proceeding will allow EPA to address commenters' issues as appropriate.

Many commenters opposed EPA's proposal to further delay the effective date of the final rule to February 19, 2019. These commenters included environmental advocacy groups, other non-governmental organizations, private citizens, an association representing fire fighters, an academic institution, and others. These commenters gave various reasons for opposing EPA's proposal to delay the final rule's effective date, which are discussed individually below.

Many commenters indicated that EPA should not delay the effective date because delaying the rule's implementation will fail to prevent or mitigate chemical accidents that will cause harm to workers at regulated facilities and members of the public in surrounding communities.

Response: EPA disagrees that further delaying the final rule's effective date will cause such harm. EPA notes that delaying the effective date of the Risk Management Program Amendments rule simply maintains the status quo, which means that the existing RMP rule remains in effect. EPA also notes that compliance dates for most major provisions of the Risk Management Program Amendments rule were set for four years after the final rule's effective date, so EPA's delay of that effective date has no immediate effect on the implementation of these requirements. As EPA has previously indicated, the existing RMP rule has been effective in preventing and mitigating chemical accidents, and these protections will remain in place during EPA's reconsideration of the Risk Management Program Amendments.12

Three commenters claimed that EPA's rulemaking to extend the effective date of the Risk Management Program Amendments rule to February 19, 2019 is arbitrary and capricious. Commenters stated several reasons that the proposed delay is arbitrary and capricious, including: The issues presented for reconsideration do not meet the statutory requirement for reconsideration under CAA section 307(d)(7)(B), and, even if any met the CAA section 307(d)(7)(B) standard, EPA lacks authority to extend a rule's effective date beyond 90 days pending reconsideration; EPA failed to explain why it is appropriate to forgo the benefits of the rule during the period of the stay; EPA failed to adequately justify its change in position; and EPA has not shown that a delay of 20 months assures compliance “as expeditiously as practicable”, as required under CAA section 112(r)(7)(A) or provides to “the greatest extent practicable” for prevention, detection, and response, as required under CAA section 112(r)(7)(B). One commenter also stated that EPA appeared “to pick the duration it proposes—20 months—out of a hat,” and provided no explanation or justification for this timeframe.

Response: EPA disagrees that this rulemaking is arbitrary and capricious. In order to conduct a rulemaking that is reasonable, and therefore not arbitrary and capricious, the courts have held that an agency must “set forth its reasons” for its decision and “establish a rational connection between the facts found and the choice made.” 13 EPA has done so here. First, the reconsideration process that EPA has initiated does meet the statutory test for such a process. As EPA stated in the proposed rule, under CAA section 307(d)(7)(B), the Administrator must commence a reconsideration proceeding if, in the Administrator's judgement, the petitioner raises an objection to a rule that was impracticable to raise during the comment period or if the grounds for the objection arose after the comment period but within the period for judicial review, and the objection is of central relevance to the outcome of the rule.

The Administrator's Letter of March 13, 2017,14 specified at least one issue—BATF's West finding—met the CAA section 307(d)(7)(B) standard for reconsideration. The letter does not reach conclusions on other issues in the RMP Coalition petition that meet this standard, but notes that at least some issues may have lacked notice and would benefit from additional comment and response. All three petitioners argued that the final rule included new requirements that were not included in the proposed rule, requirements that petitioners would have strongly objected to if they had been afforded an opportunity to comment. In particular, the petitioners cited a provision in the final rule requiring regulated facilities to disclose any information relevant to emergency planning to local emergency planners and a requirement to perform a third-party audit when an implementing agency requires such an audit due to “conditions at the stationary source that could lead to the release of a regulated substance.” Without conceding that these provisions lacked adequate notice, EPA recognizes that these provisions include core requirements for major rule provisions, and so are of central relevance to the outcome of the rule. Thus, BATF's West finding meets the criteria for reconsideration under CAA section 307(d)(7)(B), and it make practical sense for EPA to provide an opportunity for comment on these other issues in the reconsideration proceeding.15

EPA also disagrees with one commenter's assertion that the lack of discussion in the proposed rule of the forgone benefits of the rule during the period of the delay of effectiveness makes the delay arbitrary and capricious. As an initial matter, the regulatory impact analysis for the Risk Management Program Amendments was unable to conclusively show that the benefits of the final rule exceeded its costs. The lack of a quantification of benefits in the final rule regulatory impact analysis would make a quantification of forgone benefits during the period of a delay speculative at best. However, as noted above, most provisions have a compliance date of 2021, therefore any benefits from compliance would not be impacted.

In deciding whether to implement a regulation, EPA may reasonably consider not only its benefits, but also its costs. Petitioners have claimed that the final Risk Management Program Amendments' new provisions that were not included in the proposed rule may actually increase the risks and burdens to states, local communities, emergency responders, and regulated entities rather than fixing the problems identified in the proposed rule. It is completely reasonable for EPA to delay implementation of and reexamine the Risk Management Program Amendments when the Agency becomes aware of information, such as that provided by petitioners, that suggests one or more of these provisions may potentially result in harm to regulated entities and the public.

Petitioners' claims that the new final rule provisions may cause harm to regulated facilities and local communities, and the speculative but likely minimal nature of the forgone benefits, form another rational basis for EPA to delay the effectiveness of the Risk Management Program Amendments and determine whether they remain consistent with the policy goals of the Agency.

EPA also disagrees with a commenter's assertion that delaying the final rule's effective date by 20 months violates the requirement under CAA section 112(r)(7)(A) to assure compliance as expeditiously as practicable, or the requirement under CAA section 112(r)(7)(B) to promulgate reasonable regulations to the greatest extent practicable. EPA believes that the language of these sections of the CAA gives the Administrator broad authority to determine what factors are relevant to establishing effective dates that are practicable (unlike other sections of the CAA, where Congress constrained “as practicable” to include certain defined time limits). In exercising this authority, EPA believes effective dates must account for all relevant factors. In this case, delaying the effective date of the rule during the reconsideration proceeding is reasonable and practicable because the Agency does not wish to cause confusion among the regulated community and local responders by requiring these parties to prepare to comply with, or in some cases, immediately comply with, rule provisions that might be changed during the subsequent reconsideration. This is particularly true for provisions that might result in unanticipated harm to facilities and local communities, as petitioners have alleged may occur. The Agency notes that compliance with most major provisions in the final rule would not be required until 2021, so delaying the effective date of the final rule would have minimal effect on the benefits derived from compliance with these provisions.

Lastly, EPA disagrees that it picked the 20-month duration for the proposed delay in effective date “out of a hat,” or provided no explanation or justification for this timeframe. As EPA explained in the proposed rule (82 FR 16148 through 16149, April 3, 2017): “As with some of our past reconsiderations, we expect to take comment on a broad range of legal and policy issues as part of the Risk Management Program Amendments reconsideration . . .,” and,

This rationale for the proposed duration of the effective date is neither arbitrary nor capricious.

Several commenters argued that EPA did not provide a valid basis or reasoned explanation for its proposal to delay, for why the petitions should take more than three months to consider, or how the 20-month delay period was determined.

Response: The three petitions for reconsideration cover numerous policy and legal issues with the Risk Management Program Amendments. As stated in the April 3, 2017 proposal (82 FR 16148 through 16149) these issues may be difficult and time consuming to evaluate, and given the expected high level of interest from stakeholders in commenting on these issues, we proposed a longer delay of the effective date to allow additional time to open these issues for review and comment. Additionally, in both the Administrator's Letter of March 13, 2017 16 as well as the proposed delay of effectiveness rule, EPA indicated it may raise other matters we believe will benefit from additional comment (82 FR 16148 through 16149, April 3, 2017). Resolution of issues may require EPA to revise the amendments through a rulemaking process, which would involve a developing a proposal to focus comment of specific issues as well as other issues for which additional comment may be appropriate, allowing sufficient opportunity for public comment, review and respond to comments, and develop any final revisions. The rulemaking process also must allow time for Agency, inter-agency and OMB review of the proposed and final rule. Based on EPA rulemaking experience, EPA decided that a 20-month delay was warranted. Some industry commenters have pointed out that without such a delay, regulated parties would need to expend resources to prepare for compliance with the Risk Management Program Amendments final rule provisions while further changes to the program are being contemplated.

Many commenters indicated that the BATF finding of arson should not cause EPA to reconsider the final rule. These commenters indicated that Executive Order 13650 was not specifically based on the West Fertilizer event, and that EPA did not justify the Risk Management Program Amendments rule on that single incident, but rather that EPA indicated an average of approximately 150 chemical accidents have occurred each year, and the rule's provisions were intended to address all such accidents. Other commenters noted that conditions at West Fertilizer enabled the fire to escalate into a massive detonation, and lack of effective communication contributed to the needless deaths of emergency responders—issues that some rule amendments addressed by improving emergency preparedness. Some commenters also stated that the BATF finding was not actually based on evidence of arson, but rather relied on a process of elimination called “negative corpus” to project a conclusion without evidence, and therefore the BATF finding does not provide grounds for the petitioner's objection to the final rule.

Response: As an initial matter, the Agency's decision to convene a proceeding for reconsideration was made in a separate action—the Administrator's Letter of March 13, 2017. The merits of that decision are not properly subject to collateral attack in this rule. The substantive impact of the BATF finding on the policy issues opened in the reconsideration-related proposed rule may be addressed in the notice and comment period for that rule. The focus of this delay of effectiveness rule is to provide sufficient time to conduct a proceeding on the complex set of issues identified by the petitions as well as other issues that merit additional comment.

EPA disagrees that the BATF finding of arson as the cause of the West Fertilizer explosion does not provide grounds for reconsideration of the Risk Management Program Amendments final rule. While EPA agrees that the incident was not the sole justification for Executive Order 13650, and the Agency did not solely rely on it as justification for the Risk Management Program Amendments, there is no question that the event was the proximate trigger for Executive Order 13650 17 and prominently featured in the Agency's Risk Management Program Amendments proposed rule.18 EPA believes the prominence of the incident in the policy decisions underlying Executive Order 13650 and the Risk Management Program Amendments rule makes the BATF finding regarding the cause of the incident of central relevance to the rule amendments. If the cause of the West Fertilizer explosion had been known sooner, the Agency may have possibly given greater consideration to potential security risks posed by the proposed rule amendments. All three of the petitions for reconsideration and many of the commenters discuss potential security concerns with the rule's information disclosure requirements to LEPCs and the public. The RMP Coalition petition and some commenters argue that knowing that the West Fertilizer incident was an intentional, rather than an accidental act, would likely have resulted in more focus on enhanced facility security measures and justifications for the need for third-parties to obtain facility information, with protections on data use and further disclosure.

Clearly, EPA does not desire to establish regulations that increase security risks. While EPA has not concluded that the final rule would increase such risks, the petitioner's concerns, which are echoed by many other commenters, require careful consideration, and cannot be dismissed out of hand.

Regarding these commenters claims that the BATF relied on an invalid form of reasoning (i.e., “negative corpus”) to reach its conclusion regarding the cause of the West Fertilizer explosion, EPA cannot evaluate these commenters claims without obtaining detailed information on the BATF investigation. The decision to reconsider simply acknowledges the fact that BATF made this finding, that the finding went to issues of central relevance to the Risk Management Program Amendments and that the finding was late enough in the comment period to make it impracticable for many commenters to meaningfully comment on the finding's significance for the rule. The substantive merits of the BATF methodology and its conclusion would be more appropriate to consider in a reconsideration rulemaking process addressing the Risk Management Program Amendments issues impacted by the finding. To the extent questions remain concerning the cause of the West Fertilizer explosion, EPA believes these argue for finalizing the delay of effective date of the Risk Management Program Amendments in order to give the Agency time to better understand the basis for BATF's conclusions.

Accordingly, EPA has decided to finalize the proposed delay of the effective date to February 19, 2019. This delay will give the Agency an opportunity to reconsider the Risk Management Program Amendments rule, propose changes to the rule as necessary, and provide additional opportunity for members of the public to submit comments on the proposal to EPA.

Some commenters stated that EPA and the petitioners for reconsideration failed to identify objections that either arose after the period for public comment or were impracticable to raise during this period, as required under CAA section 307(d)(7)(B). One of these commenters stated that most of the objections that were raised by petitioners were “simply recycled from the comment period” and that the “remainder address issues that cannot possibly be considered “of central relevance” to the “Chemical Disaster Rule.” This commenter also indicated that several parties commented on the BATF finding during the public comment period for the Risk Management Program Amendments rulemaking, and that this demonstrated that it was not impracticable to raise the issue during the comment period. This commenter noted that EPA had responded to these comments and found that “it would be inappropriate to suspend the rulemaking based on outcomes of the incident investigation of the West Fertilizer explosion.”

Response: EPA disagrees that petitioners have failed to identify one or more objections that either arose after the period for public comment or were impracticable to raise during that period. The decision to convene a proceeding for reconsideration was made in the Administrator's Letter of March 13, 2017.19 The substance of that decision is a separate action from this rule on the length of a delay of effectiveness. Petitioners, as well as numerous commenters, including industry trade associations, regulated facilities, state government agencies, and others asserted the final rule imposed extensive new requirements on covered facilities that were not contained in the proposed rule. These commenters maintained that two major provisions of the final rule were not contained in the proposal, including a new provision in the final rule requiring regulated facilities to disclose any information relevant to emergency planning to local emergency planners, and a new trigger for third-party audits. EPA agrees that these concerns warrant additional public comment and can be incorporated into the reconsideration process for the Risk Management Program Amendments rule.20

While EPA acknowledges that several commenters included the BATF arson finding in their comments on the Risk Management Program Amendments proposed rule, the Agency does not view two days (i.e., the amount of time between BATF's announcement of its arson finding and the close of the public comment period for the Risk Management Program Amendments proposed rule) as a sufficient time period to evaluate the full implications of such important new information. Several commenters also noted that the BATF's arson finding was announced too late for them to adequately consider this information within their comments to EPA.

Also, when EPA stated, in responding to comments on the proposed Risk Management Program Amendments, that it would be inappropriate to suspend the rulemaking based on outcomes of the incident investigation of the West Fertilizer explosion, the Agency had not yet received the petitions that prompted its reconsideration proceeding, as well as comments on the proposal to delay the rule's effective date, both of which assert that the information disclosure provisions contained in the final Risk Management Program Amendments may actually increase or introduce new security risks to RMP facilities, emergency responders, and communities. EPA believes it would be remiss for the Agency to allow the final rule to become effective without fully evaluating this new information. As previously indicated, EPA does not desire to establish regulations that increase security risks.

Finally, several commenters also stated that EPA added more than 100 new documents to the rulemaking docket after the close of the comment period, and indicated that several of these documents were used by EPA to support the Agency's position on core provisions of the final rule, including the STAA and third-party audit provisions. These commenters stated that because the comment period had already closed when this information was added to the docket, the public was denied an opportunity to review and comment on the additional information. Without taking a position on whether these documents required additional comment under the rulemaking procedures of CAA section 307(d), a benefit of reopening comment on the topics that meet the reconsideration standard of CAA section 307(d)(7)(B) will be to allow for comment on some or all of these documents.

While noting their opposition to many provisions of the final regulation, an association of state and local emergency planning officials recommended that EPA allow the emergency response coordination activities provisions of § 68.93 and the emergency response program provisions of § 68.95 (and particularly paragraph (c)) 21 to go into effect immediately. This association argued that these two requirements are simple, direct, not burdensome, and in the case of § 68.95(c), essentially identical to requirements contained in the Emergency Planning and Community Right-to-Know Act (EPCRA).

Response: EPA disagrees that the emergency response coordination activities provisions of § 68.93 should immediately go into effect. These provisions contain language (i.e., “Coordination shall include providing to the local emergency planning and response organizations . . . any other information that local emergency planning and response organizations identify as relevant to local emergency response planning”) for which two petitioners (the RMP Coalition and Chemical Safety Advocacy Group) specifically objected, based on their concerns that the rule included no limitations on the information requested to be disclosed or how sensitive information can be protected. In agreeing to convene a proceeding for reconsideration of the final rule, EPA agreed to provide the public with an opportunity to comment on other issues that may benefit from additional comment and response. By finalizing these provisions immediately, EPA would not be allowing the public an additional opportunity to comment on them. Additionally, § 68.93(b) requires coordination to include consulting with local emergency response officials to establish appropriate schedules and plans for field and tabletop exercises required under § 68.96(b). As § 68.96(b) is a new section created in the final rule, EPA cannot finalize § 68.93(b) as currently written without also finalizing § 68.96(b).

Regarding this commenter's recommendation that EPA allow the emergency response program provisions of § 68.95, and particularly paragraph (c), to immediately go into effect, EPA notes that § 68.95(a)(4) also contains a reference to the new exercise requirements of § 68.96, and therefore this provision cannot go into effect without § 68.96. However, § 68.95(c) is already contained in the existing rule. In the Risk Management Program Amendments final rule, EPA simply replaced the phrase “local emergency planning committee” with the acronym “LEPC.” therefore, this requirement will remain in effect with or without the Risk Management Program Amendments final rule becoming effective.

EPA is delaying the effective date of the Risk Management Program Amendments final rule until February 19, 2019. Given the degree of complexity with the issues under review, and the likelihood of significant public interest in this reconsideration, we believe the delay we are adopting in this action is adequate and necessary for the reconsideration. While it is possible that we may require less time to complete the reconsideration, we believe delaying the effective date by a full 20 months is reasonable and prudent. This additional delay of the effective date enables EPA time to evaluate the objections raised by the various petitions for reconsideration of the Risk Management Program Amendments, provides a sufficient opportunity for public comment on the reconsideration in accordance with the requirements of CAA section 307(d), gives us an opportunity to evaluate and respond to such comments, and take any possible regulatory actions, which could include proposing and finalizing a rule to revise or rescind the Risk Management Program Amendments, as appropriate. During the reconsideration, EPA may also consider other issues, beyond those raised by petitioners, that may benefit from additional comment, and take further regulatory action.

The EPA recognizes that compliance dates for some provisions in the Risk Management Program Amendments coincided with the rule's effective date, while compliance dates for other provisions would occur in later years, i.e., 2018, 2021, or 2022, depending on the provision. Compliance with all of the rule provisions is not required as long as the rule does not become effective. The EPA did not propose and is not taking any action on any compliance dates at this time, as EPA plans to propose amendments to the compliance dates as necessary when considering future regulatory action.

Section 553(d) of the APA, 5 U.S.C. Chapter 5, generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register. EPA is issuing this final rule under § 307(d)(1) of the CAA, which states: “The provisions of section 553 through 557 * * * of Title 5 shall not, except as expressly provided in this section, apply to actions to which this subsection applies.” Thus, section 553(d) of the APA does not apply to this rule. EPA is nevertheless acting consistently with the policies underlying APA section 553(d) in making this rule effective on June 14, 2017. APA section 553(d) provides an exception when the agency finds good cause exists for a period less than 30 days before effectiveness. We find good cause exists to make this rule effective upon publication because a delay of effectiveness can only be put in place prior to a rule becoming effective. Waiting for 30 days for this rule to establish the new effective date of February 19, 2019 at this time would cause the Risk Management Amendments to become temporarily effective on June 19, 2017 (existing effective date). Avoiding this situation alleviates any potential confusion and implementation difficulties that could arise were the Risk Management Program Amendments to go into effect for a 30-day period and then be stayed during reconsideration or modified as a result of the reconsideration process.

The effective date of the Risk Management Program Amendments, published in the Federal Register on January 13, 2017 (82 FR 4594), is hereby delayed to February 19, 2019.

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

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.

This action does not impose an information collection burden under the PRA. This final rule would only delay the effective date of the Risk Management Program Amendments finalized on January 13, 2017 (see 82 FR 4594) and does not contain any information collection activities.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This final rule would not impose a regulatory burden for small entities because it only delays the effective date of the Risk Management Program Amendments finalized on January 13, 2017 (see 82 FR 4594). We have therefore concluded that this action will have no net regulatory burden for all directly regulated small entities.

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

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175. This final rule would only delay the effective date of the Risk Management Program Amendments finalized on January 13, 2017 (see 82 FR 4594) and does not impose new regulatory requirements. Thus, Executive Order 13175 does not apply to this action.

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

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This final rule only delays the effective date of the Risk Management Program Amendments finalized on January 13, 2017 (see 82 FR 4594) and does not impose any regulatory requirements.

This action does not involve technical standards.

The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This final rule only delays the effective date of the Risk Management Program Amendments finalized on January 13, 2017 (see 82 FR 4594) and does not impose any regulatory requirements.

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

Only one major rule provision of the Risk Management Program Amendments has a compliance date that will be extended by delaying the effective date to February 19, 2019. As a result, the costs for that provision are delayed and will not be incurred by the regulated community while the rule is not yet in effect. As discussed below, the costs for this delayed compliance date is small relative to the total costs of the Risk Management Program Amendments and thus, the rule further delaying the effective date is not a major rule.

In the Risk Management Program Amendments, EPA finalized the following compliance dates:

• March 14, 2018—Require compliance with emergency response coordination activities within one year of an effective date of a final rule;

• Provide three years for the owner or operator of a non-responding stationary source to develop an emergency response program in accordance with § 68.95. No specific date was established in the final rule. Instead, the three-year timeframe begins when the owner or operator determines that the facility is subject to the emergency response program requirements of § 68.95;

• March 15, 2021—Comply with new provisions (i.e., third-party compliance audits, root cause analyses as part of incident investigations, STAA, emergency response exercises, and information availability provisions), unless otherwise stated, four years after the original effective date of the final rule; and

• March 14, 2022—Provide regulated sources one additional year (i.e., five years after the original effective date of the final rule) to correct or resubmit RMPs to reflect new and revised data elements.

The compliance dates of March 15, 2021 and March 14, 2022 are not affected by this rule. Therefore, the costs for the majority of the rule provisions are not affected by this rule (i.e., third-party compliance audits, root cause analyses as part of incident investigations, STAA, emergency response exercises, and information availability provisions). We are also delaying costs associated with minor rule provisions that would have become immediately effective on June 19, 2017. However, we did not estimate any costs for these provisions. These provisions include:

• § 68.48 Safety information—revised to change “Material Safety Data Sheets” to “Safety Data Sheets (SDS);”

• § 68.50 Hazard review—revised to clarify that that the hazard review must include findings from incident investigations;

• § 68.54 & 68.71 Training—revised to clarify that employee training requirements apply to supervisors responsible for directing process operations (under 68.54) and supervisors with process operational responsibilities (under 68.71);

• § 68.60 & 68.81 Incident investigation—revised to require incident investigation reports to be completed within 12 months of the incident, unless the implementing agency approves, in writing, an extension of time;

• § 68.65 Process safety information—revised to require that process safety information be kept up-to-date;

○ Also, changed the note to paragraph (b): To replace “Material Safety Data Sheets” with “Safety Data Sheets (SDS);” and

• § 68.67 Process hazard analysis—revised to require that the PHA must now address the findings from all incident investigations required under § 68.81, as well as any other potential failure scenarios.

The only major rule provision that would be affected by this rule (because its March 14, 2018 compliance date is before the delayed effective date of this rule) is the emergency response coordination provision, which has an estimated annualized cost of $16 M.22 23 Therefore, based on the costs of the provisions that would be affected by this action, EPA has concluded that this action is not a “major rule” as defined by 5 U.S.C. 804(2).

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0255 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 14, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0255, by one of the following methods:

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

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

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

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

In the Federal Register of Wednesday, June 22, 2016 (81 FR 40594) (FRL-9947-32) and Monday, August 29, 2016 (81 FR 59165) (FRL-9950-22), EPA issued documents pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PPs) by IR-4 (PP 6E8467); and Bayer CropScience (PP 6F8461). These petitions request that 40 CFR 180.641 be amended by establishing tolerances for residues of the insecticide spirotetramat, (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, calculated as the stoichiometric equivalent of spirotetramat, in or on several commodities as follows:

Pesticide petition 6E8467 submitted by IR-4 Project Headquarters, 500 College Road East, Suite 201 W., Princeton, NJ 08540 requests tolerances for carrot, roots at 0.15 parts per million (ppm); fruit, stone, group 12-12 at 4.5 ppm; and nut, tree, group 14-12 at 0.25 ppm.

Pesticide petition 6F8461 submitted by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709 requests tolerances on sugar beet, molasses at 0.20 ppm and sugar beet, root at 0.15 ppm.

Summaries of the petitions prepared by the registrant, Bayer CropScience, are available in the docket, http://www.regulations.gov under document ID EPA-HQ-OPP-2016-0255. One comment was received in response to the notices of filings. EPA's response to the comment is discussed in Unit IV.C.

Based upon review of the data supporting the petitions, EPA has revised the tolerance levels for several proposed commodities and corrected several commodity listings. The reason for these changes are explained in Unit IV.D.

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

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

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

The target organs of toxicity following subchronic and chronic oral exposures to spirotetramat were different in rats and dogs. The thyroid and thymus glands were the target organs identified in subchronic and chronic toxicity studies in dogs while the testes were the target organs identified in rats. The dog was the most sensitive species, and in both rats and dogs, males were more sensitive than females. The thyroid effects in the dog consisted of lower circulating levels of thyroid hormones (T3 and/or T4) along with a reduction in follicle size, a possible indication of reduced amount of colloid. In all dog studies, thymus effects were observed (reduced size, atrophy). In the one-year study, this was described microscopically as involution.

In rats, reported testicular effects consisted of abnormal spermatozoa and hypospermia in the epididymis, decreased testicular weights, and testicular degenerative vacuolation. An investigative subchronic study where rats were dosed with a primary enol metabolite of spirotetramat reproduced the same testicular effects as the parent chemical, suggesting that this metabolite is, at minimum, a primary contributor to the observed male reproductive toxicity. Consistent with this notion, orally administered spirotetramat was demonstrated in rats to be extensively metabolized, and males were noted to achieve much higher systemic exposures than their female counterparts, which helps explain the higher sensitivity of males. Other effects reported in a rat chronic toxicity study were associated with kidney effects consisting of decreased organ weight and tubular dilatation.

In one- and two-generation rat reproductive toxicity studies, male reproductive toxicity (abnormal sperm cells and reproductive performance) similar to that reported in subchronic toxicity studies with adult rats was reported in the first generation (F1) males at relatively high dose levels. In all cases, a well-defined no-observed adverse-effect level (NOAEL) was established.

There was evidence of increased qualitative susceptibility in the rat developmental study with reduced fetal weight and increased incidences of malformations and skeletal deviations observed at the limit dose, while maternal effects at this dose consisted of only body-weight decrements. There was no evidence of increased quantitative or qualitative susceptibility to offspring following pre- or post-natal exposure to spirotetramat in the rabbit developmental or two-generation reproduction studies.

The only evidence of neurotoxicity in the rat acute neurotoxicity study was based on decreased motor and locomotor activity, which occurred only at relatively high dose levels. The rat subchronic neurotoxicity (SCN) study does not indicate a concern for neurotoxicity, even at relatively high dose levels. The results of an immunotoxicity study in rats do not indicate any functional deficits in immune function.

There is no evidence of carcinogenicity in chronic toxicity/carcinogenicity studies performed in rats and mice. Spirotetramat has been classified as “not likely to be carcinogenic to humans” based on lack of evidence for carcinogenicity in rodent studies. Spirotetramat was also negative for mutagenicity and clastogenicity in in vivo and in vitro assays.

Specific information on the studies received and the nature of the adverse effects caused by spirotetramat as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: “Spirotetramat. Human Health Risk Assessment for the Tolerance Petition for Residues in/on Sugar Beet and Carrot and Crop Group Conversions for Tree Nut Group 14-12 and Fruit, Stone, Group 12-12.” at pages 25-30 in docket ID number EPA-HQ-OPP-2016-0255.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for spirotetramat used for human risk assessment is discussed in Unit III. B. Toxicological Points of Departure/Levels of Concern of the final rule published in the Federal Register of Tuesday, October 25, 2016 (81 FR 73342) (FRL-89951-80).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to spirotetramat, EPA considered exposure under the petitioned-for tolerances as well as all existing spirotetramat tolerances in 40 CFR 180.641. EPA assessed dietary exposures from spirotetramat in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for spirotetramat.

In estimating acute dietary exposure, EPA used food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA) from 2003 through 2008. As to residue levels in food, EPA assumed tolerance-level residues, 100 percent crop treated (PCT) information for all commodities and Dietary Exposure Evaluation Model (DEEM) 7.81 default processing factors where available.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA's 2003-2008 NHANES/WWEIA. As to residue levels in food, EPA used 100 PCT, average field trial residues for some commodities, and tolerance-level residues for the remaining commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that spirotetramat does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

The Agency did not use percent crop treated estimates.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for spirotetramat in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of spirotetramat. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of spirotetramat and its metabolites and degradates of concern for acute exposures are estimated to be 395 parts per billion (ppb) for surface water and 7.99 ppb for ground water.

Chronic exposures for non-cancer assessments are estimated to be 395 ppb for surface water and 5.36 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For both acute and chronic dietary risk assessment, the water concentration value of 395 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Spirotetramat is currently registered for the following uses that could result in residential exposures: Citrus trees grown in residential areas and turf grass including sod farm and golf course turf only. There is the potential for post-application dermal exposure from both residential citrus tree and golf course uses. The golf course use could result in potential post-application dermal exposure; however, there is no dermal hazard and therefore, quantification of dermal risk is not necessary. For the residential citrus tree use, because the product is sold in bulk packaging for agricultural uses and the label requires that handlers wear specific clothing (e.g., long-sleeve shirt/long pants) and the use of personal-protective equipment (e.g., gloves), based on current Agency policy, EPA has made the assumption that this product is not meant for homeowner use, and therefore, there is no need to conduct a quantitative residential handler assessment.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to spirotetramat and any other substances and spirotetramat does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that spirotetramat has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at: http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no evidence of quantitative susceptibility of offspring following pre- or postnatal exposure to spirotetramat. There is evidence of qualitative susceptibility in the rat developmental study, where developmental effects, including reduced fetal weight and increased incidences of malformations and skeletal deviations, were observed in the presence of body weight decrements in maternal animals. However, concern is low since effects were only seen at the limit dose and selected endpoints are protective of the observed effects.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for spirotetramat is complete.

ii. Although spirotetramat was shown to elicit neurotoxic response in the acute neurotoxicity study; however, concern is low since the effects are well-characterized with clearly established NOAEL/LOAEL values, the selected endpoints are protective of the observed neurotoxic effect, there are no neurotoxic effects seen in the subchronic neurotoxicity study, and the existing toxicological database indicates that spirotetramat is not a neurotoxic chemical.

iii. There is no evidence of quantitative susceptibility of offspring following pre- or postnatal exposure. There is evidence of qualitative susceptibility in the rat developmental study; however, there is no residual uncertainty concerning these effects due to the clear NOAEL/LOAELs in the study for these effects. Moreover, concern for these effects is low since effects were only seen at the limit dose, effects were seen in the presence of maternal toxicity, and selected endpoints are protective of the observed effects.

iv. There are no residual uncertainties identified in the exposure databases. The acute dietary food and drinking water exposure assessment utilizes tolerance-level residues and 100 PCT information for all commodities. The chronic dietary food and drinking water exposure assessment utilizes average field trial residues for some commodities, tolerance-level residues for the remaining commodities, and 100 PCT. The chronic assessment is somewhat refined; however, since it is based on reliable data, it will not underestimate exposure and risk. There are no quantifiable potential exposure/risks from residential citrus tree and golf course uses. The drinking water assessments provide conservative, health-protective, high-end estimates of water concentrations that will not likely be exceeded. These assessments will not underestimate the exposure and risks posed by spirotetramat.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to spirotetramat will occupy 16% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to spirotetramat from food and water will utilize 77% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short- and Intermediate-term risks. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposure to food and water (considered to be a background exposure level). A short- and intermediate-term inhalation adverse effect was identified; however, spirotetramat is not registered for any use patterns that would result in either short- or intermediate-term inhalation residential exposure. In a dermal toxicity study, no evidence of dermal hazard was found; therefore, dermal risk was not included in the aggregate assessment. Short- and intermediate-term aggregate risks are assessed based on short- and intermediate-term residential exposures plus chronic dietary exposure. Because there is no short- or intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short- or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short- and intermediate-term risks for spirotetramat.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, spirotetramat is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to spirotetramat residues.

Adequate enforcement methodology (high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS)) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

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

The Codex has not established a MRL for spirotetramat.

One comment was received from an anonymous source requesting that the Agency deny IR-4's petition for use of spirotetramat on all food items claiming it is a toxic chemical and its use would result in harm to humans.

The Agency's Response: The Agency recognizes that some individuals believe that certain pesticides are “toxic chemicals” that should not be permitted in our food; however, the commenter provided no information demonstrating toxicity of spirotetramat or that EPA could use to evaluate the safety of the pesticide. The existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. When new or amended tolerances are requested for residues of a pesticide in food or feed, the Agency, as is required by Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), estimates the risk of the potential exposure to these residues. The Agency has concluded after this risk assessment, which includes the consideration of long-term animal studies with spirotetramat, that there is a reasonable certainty that no harm will result from aggregate human exposure to spirotetramat and that, accordingly, the use of spirotetramat on petitioned-for food commodities is “safe.”

Based on available residue data, EPA is establishing tolerance level on sugar beet molasses at 0.30 ppm instead of 0.20 ppm, to cover anticipated residues. In addition, EPA corrected the commodity terminology for “sugar beet root” and “sugar beet molasses” to “beet, sugar, roots” and “beet, sugar, molasses,” respectively, in order to conform to terms used in the Agency's Food and Feed Commodity Vocabulary.

Therefore, tolerances are established for residues of spirotetramat, (cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl-ethyl carbonate) and its metabolites cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]dec-3-en-2-one, cis-3-(2,5-dimethylphenyl)-3-hydroxy-8-methoxy-1-azaspiro[4.5]decane-2,4-dione, cis-3-(2,5-dimethylphenyl)-8-methoxy-2-oxo-1-azaspiro[4.5]dec-3-en-4-yl beta-D-glucopyranoside, and cis-3-(2,5-dimethylphenyl)-4-hydroxy-8-methoxy-1-azaspiro[4.5]decan-2-one, calculated as the stoichiometric equivalent of spirotetramat, in or on beet, sugar, molasses at 0.30 ppm; beet, sugar, roots at 0.15 ppm; carrot, roots at 0.15 ppm; fruit, stone, group 12-12 at 4.5 ppm; and nut, tree, group 14-12 at 0.25 ppm. In addition, EPA is revoking the existing tolerances for fruit, stone, group 12 and nut, tree, group 14 as they are superseded by the new tolerances for groups 12-12 and 14-12 established under this final rule.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0263 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 14, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0263, by one of the following methods:

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

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

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

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

In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956-86), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6F8457) by ISK Biosciences Corporation, 7470 Auburn Rd., Suite A, Concord, OH 44077. The petition requested that 40 CFR 180.681 be amended by establishing tolerances for residues of the fungicide isofetamid, N-[1,1-dimethyl-2-[2-methyl-4-(1-methylethoxy)phenyl]-2-oxoethyl]-3-methyl-2-thiophenecarboxamide, in or on caneberry subgroup 13-07A at 3.0 parts per million (ppm); apple, wet pomace, at 2.0 ppm; bushberry, subgroup 13-07B at 6.0 ppm; cattle, fat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; cherry subgroup 12-12A at 5.0 ppm; fruit, pome, group 11-10 at 0.6 ppm; fruit, small vine climbing, except grape, subgroup 13-7E at 9.0 ppm; goat, fat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; horse, fat at 0.01 ppm; horse, meat byproducts at 0.01 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, except cowpea and field pea at 0.05 ppm; pea and bean, succulent shelled, subgroup 6B, except cowpea at 0.04 ppm; peach subgroup 12-12B at 3.0 ppm; plum, prune, dried at 3.5 ppm; plum subgroup 12-12C at 0.8 ppm; sheep, fat at 0.01 ppm; sheep, meat byproducts at 0.01 ppm; and vegetable, legume, edible podded, subgroup 6A at 1.5 ppm. That document referenced a summary of the petition prepared by ISK Biosciences Corporation, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised some of the proposed tolerances; determined that tolerances for residues in livestock commodities are not required; and corrected some of the commodity definitions. The reason for these changes are explained in Unit IV.D.

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

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

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The toxicology database is complete for isofetamid. In repeated dose studies, the liver was the primary target organ in the rat, mouse, and dog, as indicated by increased liver weights, changes in the clinical chemistry values, and liver hypertrophy. A second target organ was the thyroid in the rat and dog, as indicated by changes in thyroid weights and histopathology. Adrenal weight changes were observed in the subchronic rat and dog studies. In the rat and dog, the dose levels where toxicity was observed were similar or higher in the chronic studies compared with the respective subchronic studies, showing an absence of progression of liver toxicity with time. There was no evidence of carcinogenicity in the rat or mouse cancer studies; the mutagenicity battery was negative. There are no genotoxicity, neurotoxicity, or immunotoxicity concerns observed in the available toxicity studies. Developmental toxicity was not observed in the rat or rabbit, and offspring effects such as decreased body weight were seen only in the presence of parental toxicity in the multi-generation rat study. Isofetamid is classified as “Not Likely to be Carcinogenic to Humans” based on the absence of increased tumor incidence in acceptable/guideline carcinogenicity studies in rats and mice. Isofetamid is not acutely toxic; it is classified as Toxicity Category III for acute oral and dermal exposure, and Toxicity Category IV for inhalation exposure. Furthermore, it is not irritating to the eye or skin, and it is not a dermal sensitizer.

Specific information on the studies received and the nature of the adverse effects caused by isofetamid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are can be found at http://www.regulations.gov in document Isofetamid. Aggregate Human Health Risk Assessment for the Proposed New Agricultural Uses on Bushberry, Subgroup 13-07B; Caneberry, Subgroup 13-07A; Cherry, Subgroup 12-12A; Dried Shelled Pea and Bean, Except Soybean, Subgroup 6C; Edible-Podded Legume Vegetables, Subgroup 6A; Peach, Subgroup 12-12B; Plum, Subgroup 12-12C; Pome Fruit, Group 11-10; Small Vine Climbing Fruit, Except Grape, Subgroup 13-07E; Succulent Shelled Pea and Bean, Subgroup 6B; as well as Livestock Commodities; in Addition to Uses on Ornamental Plants (including Residential Use Sites). pages 12-18 in docket ID number EPA-HQ-OPP-2016-0263.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for isofetamid used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of July 30, 2015 (80 FR 45440) (FRL-9923-86).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to isofetamid, EPA considered exposure under the petitioned-for tolerances as well as all existing isofetamid tolerances in 40 CFR 180.681. EPA assessed dietary exposures from isofetamid in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for isofetamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. An unrefined chronic (food and drinking water) dietary assessment was conducted for all registered and proposed food uses of isofetamid using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic dietary (food and drinking water) exposure assessment for isofetamid incorporated existing tolerance-level residues, Agency-recommended tolerance-level residues for proposed tolerances, DEEM default processing factors, and 100 PCT (percent crop treated). Some tolerance levels were adjusted to include residues of the metabolite, GPTC (a residue of concern for risk assessment). DEEM default processing factors were used for dried apples, apple juice, dried pear, cherry juice, dried apricot, dried peach, plum, prune juice, cranberry juice, and grape juice. The EDWC of 110 microgram/Liter (µg/L) was incorporated directly into the dietary assessment.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that isofetamid does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for isofetamid. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for isofetamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of isofetamid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Pesticide Flooded Application Model and the Pesticide Root Zone Model Ground Water (PRZM GW) the estimated drinking water concentrations (EDWCs) of isofetamid for chronic exposures for non-cancer assessments are estimated to be 110 parts per billion (ppb) for surface water and 43 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration value of 110 ppb was used to assess the contribution from drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Isofetamid is currently registered for the following uses that could result in residential exposures: Turfgrass including golf courses, residential lawns, and recreational turfgrass. It is currently under review for registering use on ornamental plants. The proposed ornamental use is not intended for homeowner use and therefore a quantitative residential handler assessment was not conducted. Additionally, post-application exposures for adults and children are expected to be negligible. However, the existing turf use may result in short- and intermediate-term exposures. Residential exposure may occur by the dermal and incidental oral routes of exposures following the application of isofetamid on residential turf. However, since dermal hazard has not been identified for isofetamid, the only exposure scenario quantitatively assessed is for post-application incidental oral (for children 1 to <2 years old). These exposures have been assessed with current policies, which include the Agency's 2012 Residential Standard Operating Procedures (http://www.epa.gov/pesticides/science/residential-exposure-sop.html) along with policy changes for body weight assumptions.

Even though a previous risk assessment identified residential handler risk estimates for use in aggregate assessment, based on current policy and that isofetamid products are intended for sale/use to/by professional applicators, residential handler exposure assessments for turf are no longer applicable to the isofetamid aggregate risk assessment. Therefore, the aggregate assessment for this action only includes a risk contribution from residential post-application incidental oral exposure for children 1 to <2 years old.

There is the potential for post-application exposure for individuals as a result of being in an environment that has been previously treated with isofetamid such as residential ornamental lawns. Since dermal hazard has not been identified for isofetamid, a quantitative assessment for dermal exposure is not necessary and the only exposure scenarios quantitatively assessed are for children 1 to <2 years old who may experience short-term incidental oral exposure to isofetamid from treated turf. Intermediate-term incidental oral post-application exposures are possible (i.e., from soil ingestion due to the persistence of isofetamid); however, the short-term incidental oral exposures are protective of the possible intermediate-term incidental oral exposures because the POD for both durations is the same. Post-application inhalation exposure is expected to be negligible for the proposed residential uses.

The post-application incidental oral MOE values were calculated based on the scenario of liquid application of isofetamid to turf. Post-application risk estimates for all incidental oral scenarios are not of concern (MOEs range from 5,900 to 4,000,000). The incidental oral scenarios (i.e., hand-to-mouth and object-to-mouth) should be considered inter-related and it is likely that they occur interspersed amongst each other across time. However, combining these scenarios would be overly-conservative because of the conservative nature of each individual assessment. Incidental oral risk estimates are highly conservative because the short- and intermediate-term incidental oral POD is based on a 90-day exposure duration which represents daily exposure for 90 days. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

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

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no evidence of developmental toxicity or reproductive susceptibility, and there are no residual uncertainties concerning pre- or post-natal toxicity or exposure.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for isofetamid is complete.

ii. There is no indication that isofetamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that isofetamid results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to isofetamid in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by isofetamid.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, isofetamid is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to isofetamid from food and water will utilize 4.0% of the cPAD for children (1-2 years old), the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of isofetamid is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Isofetamid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to isofetamid.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in an aggregate MOE of 1,600 for children (1-2 years old). Because EPA's level of concern for isofetamid is a MOE of 100 or below, this MOE is not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, isofetamid is not registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for isofetamid.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, isofetamid is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to isofetamid residues.

Adequate enforcement methodology liquid chromatography with tandem mass spectrometry (LC-MS/MS) method is available to enforce the tolerance expression. Multiresidue methods testing data have been submitted for isofetamid and GPTC. The data indicate that multiresidue methods are not suitable for analysis of isofetamid and GPTC, so the multiresidue methods cannot serve as enforcement methods. The multiresidue data have been forwarded to the Food and Drug Administration (FDA).

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

The Codex has not established MRLs for isofetamid. There are no Canadian, Codex, or Mexican maximum residue limits (MRLs) for isofetamid in/on the commodities included in this petition.

All tolerance levels are based upon the Organization for Economic Co-operation and Development's (OECD) tolerance calculation procedures. Thus, the tolerance levels established in this notice for isofetamid in/on bushberry, subgroup 13-07B; cherry, subgroup 12-12A; plum, prune, dried; dried shelled pea and bean, except soybean, subgroup 6C; and succulent shelled pea and bean, subgroup 6B are lower than those requested by the petitioner. The tolerance levels established in this notice for caneberry, subgroup 13-07A and fruit, small vine climbing, except grape, subgroup 13-07E are higher than those requested by the petitioner based on the OECD calculation procedures.

Additionally, the Agency has determined that tolerances requested for residues in livestock commodities are not required. These tolerances fall under 40 CFR 180.6(a)(3) regarding secondary residues in livestock commodities, i.e., it is not possible to establish with certainty whether finite residues will be incurred, but there is no reasonable expectation of finite residues.

The following commodity definitions have been corrected: Bushberry subgroup 13-07B; fruit, small vine climbing, except grape, subgroup 13-07E; pea and bean, dried shelled, except soybean, subgroup 6C; and pea and bean, succulent shelled, subgroup 6B.

Therefore, tolerances are established for residues of isofetamid, in or on apple, wet pomace, at 2.0 parts per million (ppm); bushberry subgroup 13-07B at 5.0 ppm; caneberry subgroup 13-07A at 4.0 ppm; cherry subgroup 12-12A at 4.0 ppm; fruit, pome, group 11-10 at 0.60 ppm; fruit, small vine climbing, except grape, subgroup 13-07E at 10.0 ppm; pea and bean, dried shelled, except soybean, subgroup 6C, at 0.040 ppm; pea and bean, succulent shelled, subgroup 6B, at 0.030 ppm; peach subgroup 12-12B at 3.0 ppm; plum, prune, dried at 1.50 ppm; plum subgroup 12-12C at 0.80 ppm; and vegetable, legume, edible podded, subgroup 6A at 1.50 ppm. Additionally, the existing time-limited tolerances are being removed for both Caneberry subgroup 13-07A at 4.0 ppm, and for Bushberry subgroup 13-07B at 5.0 ppm.

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

Entities potentially regulated by this action include:

This section is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated or affected by this final rule. Other types of entities that do not meet the above criteria could also be regulated. To determine whether your facility would be regulated by this final rule, you should carefully examine the applicability criteria listed in § 441.10 and the definitions in § 441.20 of this final rule and detailed further in Section VI of this preamble. If you still have questions regarding the applicability of this final rule to a particular entity, consult the person listed for technical information in the preceding FOR FURTHER INFORMATION CONTACT section.

This final rule is supported by a number of documents including the Technical and Economic Development Document for the Final Effluent Limitations Guidelines and Standards for the Dental Category (TEDD), Document No. EPA-821-R-16-005. The TEDD and additional records are available in the public record for this final rule and on EPA's Web site at https://www.epa.gov/eg/dental-effluent-guidelines.

EPA promulgates this regulation under the authorities of sections 101, 301, 304, 306, 307, 308, and 501 of the CWA, 33 U.S.C. 1251, 1311, 1314, 1316, 1317, 1318, 1342 and 1361 and pursuant to the Pollution Prevention Act of 1990, 42 U.S.C. 13101 et seq.

The purpose of this final rule is to set a uniform national standard that will greatly reduce the discharge of mercury-containing dental amalgam to municipal sewage treatment plants, known as POTWs, in the United States. Mercury is a potent neurotoxin that bioaccumulates in fish and shellfish, and mercury pollution is widespread and a global concern that originates from many diverse sources such as air deposition from municipal and industrial incinerators and combustion of fossil fuels. Across the U.S., 12 states and at least 18 localities have established mandatory programs to reduce discharges of mercury to POTWs. As a result of these efforts, along with outreach from the ADA to promote voluntary actions to reduce such discharges, approximately 40 percent of the dentists subject to this rule already have installed amalgam separators. Amalgam separators greatly reduce the discharge of mercury-containing amalgam to POTWs. Amalgam separators are a practical, affordable and readily available technology for capturing mercury at dental offices. The mercury collected by these separators can be recycled. This rule will ensure that mercury discharges to POTWs are effectively controlled at dental offices that discharge wastewater to POTWs.

Many studies have been conducted in an attempt to identify the sources of mercury entering POTWs. According to the 2002 Mercury Source Control and Pollution Prevention Program Evaluation Final Report (DCN DA00006) prepared by the Association of Metropolitan Sewerage Agencies (AMSA), dental offices are the main source of mercury discharges to POTWs. A study funded by the ADA published in 2005 estimated that dental offices contributed 50 percent of mercury entering POTWs (DCN DA00163). Mercury is discharged in the form of waste dental amalgam when dentists remove old amalgam fillings from cavities, and from excess amalgam waste when a dentist places a new amalgam filling.

While dental offices are not a major contributor of mercury to the environment generally, dental offices are the main source of mercury discharges to POTWs. EPA estimates that across the United States 5.1 tons of mercury and an additional 5.3 tons of other metals found in waste dental amalgam are collectively discharged into POTWs annually. Mercury entering POTWs frequently partitions into the sludge, the solid material that remains after wastewater is treated. Mercury from waste amalgam therefore can make its way into the environment from the POTW through the incineration, landfilling, or land application of sludge or through surface water discharge. Once released into the aquatic environment, certain bacteria can change mercury into methylmercury, a highly toxic form of mercury that bioaccumulates in fish and shellfish. In the U.S., consumption of fish and shellfish is the main source of methylmercury exposure to humans. Removing mercury when it is in a concentrated and easy to manage form in dental amalgam, before it becomes diluted and difficult and costly to remove, is a common sense step to prevent mercury from being released into the environment where it can become a hazard to humans.

The ADA, which supported removal and recycling of mercury from wastewater discharged to POTWs in its comments on the 2014 proposed rule (See DCN EPA-HQ-OW-2014-0693-0434), developed best management practices (BMPs) to facilitate this goal and shared its recommendations widely with the dental community (DCN DA00165). The ADA's voluntary amalgam waste handling and disposal practices include the use of amalgam separators to reduce mercury discharges. In addition, some states and localities have implemented mandatory programs to reduce dental mercury discharges that include the use of amalgam separators.

EPA has concluded that requiring dental offices to remove mercury through relatively low-cost and readily available amalgam separators and BMPs makes sense. Capturing mercury-laden waste where it is created prevents it from being released into the environment. This final rule controls mercury discharges to POTWs by establishing a performance standard for amalgam process wastewater based on the use of amalgam separator technology. The rule also requires dental dischargers to adopt two BMPs, one which prohibits the discharge of waste (“or scrap”), and the other which prohibits the use of line cleaners that may lead to the dissolution of solid mercury when cleaning chair-side traps and vacuum lines.

In addition, the rule minimizes the administrative burden on dental offices subject to the rule, as well as on federal, state, and local regulatory authorities responsible for oversight and enforcement of the new standard. Administrative burden was a concern of many of the commenters on the 2014 proposed rule and EPA has greatly reduced that burden through streamlining the administrative requirements in this final rule.

When EPA establishes categorical pretreatment requirements, it triggers additional oversight and reporting requirements in EPA's General Pretreatment Regulations. The General Pretreatment Regulations specify that Control Authorities (which are often the state or POTW) are responsible for administering and enforcing pretreatment standards, including receiving and reviewing compliance reports. While other industries subject to categorical pretreatment standards typically consist of tens to hundreds of facilities, the dental industry consists of approximately 130,000 offices. Application of the default General Pretreatment Regulation oversight and reporting requirements to such a large number of facilities would be much more challenging. Further, dental office discharges differ from other industries for which EPA has established categorical pretreatment standards. Both the volume of wastewater discharged and the quantity of pollutants in the discharge on a per facility basis are significantly less than other industries for which EPA has established categorical pretreatment standards. Accordingly, this final rule exempts dental offices from the General Pretreatment Regulations' oversight and reporting requirements associated with categorical pretreatment standards, reflecting EPA's recognition that the otherwise-applicable regulatory framework for categorical dischargers would be unlikely to have a significant positive impact on overall compliance with the rule across the dental industry, while imposing a substantial burden on state and local regulating authorities.

In order to simplify implementation and compliance for the dental offices and the regulating authorities, the final rule establishes that dental dischargers are not Significant Industrial Users (SIUs) as defined in 40 CFR part 403, and are not Categorical Industrial Users (CIUs) or “industrial users subject to categorical pretreatment standards” as those terms and variations are used in the General Pretreatment Regulations, unless designated such by the Control Authority. While this rule establishes pretreatment standards that require dental offices to reduce dental amalgam discharges, the rule does not require Control Authorities to implement the traditional suite of oversight requirements in the General Pretreatment Regulations that become applicable upon the promulgation of categorical pretreatment standards for an industrial category. This significantly reduces the reporting requirements for dental dischargers that would otherwise apply by instead requiring them to demonstrate compliance with the performance standard and BMPs through a one-time compliance report to their Control Authority. This regulatory approach also eliminates the additional oversight requirements for Control Authorities that are typically associated with SIUs, such as permitting and annual inspections of individual dental offices. It also eliminates additional reporting requirements for the Control Authorities typically associated with CIUs, such as identification of CIUs in their annual pretreatment reports. At the same time, the final rule recognizes the Control Authority's discretionary authority to treat a dental discharger as an SIU and/or CIU if, in the Control Authority's judgement, it is necessary.

EPA estimated the annual costs associated with this rule. EPA's analysis reflects that many dental offices have already taken steps to reduce dental amalgam discharges by discontinuing the use of dental amalgam, adopting the ADA's voluntary best practices, or by meeting existing mandatory state or local requirements. On a national basis, EPA estimates that approximately 40 percent of dental offices subject to this final rule already use amalgam separators (DCN DA00456). Of the remaining 60 percent of dental offices that do not have amalgam separators and that are subject to this final rule, EPA estimates that 20 percent do not place or remove dental amalgam (DCN DA00161). These dentists that do not place or remove dental amalgam—which correspond to 12 percent of the dental offices subject to this final rule—will incur little to no costs as a result of the rule. EPA estimates the remainder (representing 48 percent of the dental offices subject to this final rule) will incur an approximate average annual cost of $800 per office. The total annual cost of this final rule is projected to be $59-$61 million.

This final rule will produce human health and ecological benefits by reducing the estimated annual nationwide POTW discharge of dental mercury to surface water from 1,003 pounds to 11 pounds. Studies show that decreased point-source discharges of mercury to surface water have resulted in lower methylmercury concentrations in fish, and that such reductions can result in quantifiable economic benefits from improved human health and ecological conditions (DCN DA00148). While not quantified, as noted above, this rule will also reduce mercury releases to the environment associated with the incineration, landfilling, or land application of POTW sludges. Instead, EPA expects all of the collected amalgam will be recycled, rather than released back into the environment.

Congress passed the Federal Water Pollution Control Act Amendments of 1972, also known as the Clean Water Act (CWA), to “restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” (33 U.S.C. 1251(a)). The CWA establishes a comprehensive program for protecting our nation's waters. Among its core provisions, the CWA prohibits the discharge of pollutants from a point source to waters of the U.S. except as authorized under the CWA. Under section 402 of the CWA, EPA authorizes discharges by a National Pollutant Discharge Elimination System (NPDES) permit. The CWA establishes a two- pronged approach for these permits: Technology-based controls that establish the floor of performance for all dischargers, and water quality-based limits where the technology-based limits are insufficient for the discharge to meet applicable water quality standards. To serve as the basis for the technology-based controls, the CWA authorizes EPA to establish national technology-based effluent limitations guidelines and new source performance standards for discharges from different categories of point sources, such as industrial, commercial, and public sources, that discharge directly into waters of the U.S.

Direct dischargers (those discharging directly to surface waters) must comply with effluent limitations in NPDES permits. Technology-based effluent limitations in NPDES permits for direct dischargers are derived from effluent limitations guidelines (CWA sections 301 and 304) and new source performance standards (CWA section 306) promulgated by EPA, or based on best professional judgment where EPA has not promulgated an applicable effluent guideline or new source performance standard (CWA section 402(a)(1)(B) and 40 CFR 125.3). The effluent guidelines and new source performance standards established by regulation for categories of industrial dischargers are based on the degree of control that can be achieved using various levels of pollution control technology, as specified in the Act.

EPA promulgates national effluent limitations guidelines and standards of performance for major industrial categories for three classes of pollutants: (1) Conventional pollutants (total suspended solids, oil and grease, biochemical oxygen demand, fecal coliform, and pH) as outlined in CWA section 304(a)(4) and 40 CFR 401.16; (2) toxic pollutants (e.g., toxic metals such as chromium, lead, mercury, nickel, and zinc) as outlined in section 307(a) of the Act, 40 CFR 401.15 and 40 CFR part 423, appendix A; and (3) non-conventional pollutants, which are those pollutants that are not categorized as conventional or toxic (e.g., ammonia-N, formaldehyde, and phosphorus).

The CWA also authorizes EPA to promulgate nationally applicable pretreatment standards that restrict pollutant discharges from facilities that discharge pollutants indirectly, by sending wastewater to POTWs, as outlined in sections 307(b), (c) and 304(g) of the CWA. EPA establishes national pretreatment standards for those pollutants that may pass through, interfere with, or may otherwise be incompatible with POTW operations. CWA sections 307(b) and (c) and 304(g). The legislative history of the 1977 CWA amendments explains that pretreatment standards are technology-based and analogous to technology-based effluent limitations for direct dischargers for the removal of toxic pollutants. As further explained in the legislative history, the combination of pretreatment and treatment by the POTW is intended to achieve the level of treatment that would be required if the industrial source were making a direct discharge. Conf. Rep. No. 95-830, at 87 (1977), reprinted in U.S. Congress. Senate. Committee on Public Works (1978), A Legislative History of the CWA of 1977, Serial No. 95-14 at 271 (1978). As such, in establishing pretreatment standards, EPA's consideration of pass through for national technology-based categorical pretreatment standards differs from that described in EPA's General Pretreatment regulations at 40 CFR part 403. For categorical pretreatment standards, EPA's approach for pass through satisfies two competing objectives set by Congress: (1) That standards for indirect dischargers be equivalent to standards for direct dischargers; and (2) that the treatment capability and performance of the POTWs be recognized and taken into account in regulating the discharge of pollutants from indirect dischargers. CWA 301(b)(1)(A)(BPT); and 301(b)(1)(E).

EPA develops Effluent Guidelines Limitations and Standards (ELGs) that are technology-based regulations for specific categories of dischargers. EPA bases these regulations on the performance of control and treatment technologies. The legislative history of CWA section 304(b), which is the heart of the effluent guidelines program, describes the need to press toward higher levels of control through research and development of new processes, modifications, replacement of obsolete plants and processes, and other improvements in technology, taking into account the cost of controls. Congress has also stated that EPA need not consider water quality impacts on individual water bodies as the guidelines are developed; see Statement of Senator Muskie (October 4, 1972), reprinted in U.S. Senate Committee on Public Works, Legislative History of the Water Pollution Control Act Amendments of 1972, Serial No. 93-1, at 170).

There are standards applicable to direct dischargers (dischargers to surface waters) and standards applicable to indirect dischargers (dischargers to POTWs). The types of standards relevant to this rulemaking are summarized here.

BAT represents the second level of stringency for controlling direct discharge of toxic and nonconventional pollutants. In general, BAT-based effluent guidelines and new source performance standards represent the best available economically achievable performance of facilities in the industrial subcategory or category. Following the statutory language, EPA considers the technological availability and the economic achievability in determining what level of control represents BAT. CWA section 301(b)(2)(A). Other statutory factors that EPA considers in assessing BAT are the cost of achieving BAT effluent reductions, the age of equipment and facilities involved, the process employed, potential process changes, and non- water quality environmental impacts, including energy requirements and such other factors as the Administrator deems appropriate. CWA section 304(b)(2)(B). The Agency retains considerable discretion in assigning the weight to be accorded these factors. Weyerhaeuser Co. v. Costle, 590 F.2d 1011, 1045 (D.C. Cir. 1978).

NSPS reflect effluent reductions that are achievable based on the best available demonstrated control technology (BADCT). Owners of new facilities have the opportunity to install the best and most efficient production processes and wastewater treatment technologies. As a result, NSPS should represent the most stringent controls attainable through the application of the BADCT for all pollutants (that is, conventional, nonconventional, and toxic pollutants). In establishing NSPS, EPA is directed to take into consideration the cost of achieving the effluent reduction and any non-water quality environmental impacts and energy requirements. CWA section 306(b)(1)(B).

Pretreatment standards apply to dischargers of pollutants to POTWs; Pretreatment Standards for Existing Sources are designed to prevent the discharge of pollutants to POTWs that pass through, interfere with, or are otherwise incompatible with the operation of POTWs, including sludge disposal methods of POTWs. Categorical pretreatment standards for existing sources are technology-based and are analogous to BAT effluent limitations guidelines, and thus the Agency typically considers the same factors in promulgating PSES as it considers in promulgating BAT. See Natural Resources Defense Council v. EPA, 790 F.2d 289, 292 (3rd Cir. 1986).

Like PSES, PSNS are designed to prevent the discharges of pollutants that pass through, interfere with, or are otherwise incompatible with the operation of POTWs. New indirect discharges have the opportunity to incorporate into their facilities the best available demonstrated technologies. In establishing pretreatment standards for new sources, the Agency typically considers the same factors in promulgating PSNS as it considers in promulgating NSPS (BADCT).

Section 304(e) of the CWA authorizes the Administrator to publish regulations, in addition to effluent limitations guidelines and standards for certain toxic or hazardous pollutants, “to control plant site runoff, spillage or leaks, sludge or waste disposal, and drainage from raw material storage which the Administrator determines are associated with or ancillary to the industrial manufacturing or treatment process . . . and may contribute significant amounts of such pollutants to navigable waters.” In addition, section 304(g), read in concert with section 501(a), authorizes EPA to prescribe as wide a range of pretreatment requirements as the Administrator deems appropriate in order to control and prevent the discharge into navigable waters, either directly or through POTWs, any pollutant which interferes with, passes through, or otherwise is incompatible with such treatment works. (see also Citizens Coal Council v. U.S. EPA, 447 F3d 879, 895-96 (6th Cir. 2006) (upholding EPA's use of non-numeric effluent limitations and standards); Waterkeeper Alliance, Inc. v. U.S. EPA, 399 F.3d 486, 496-97, 502 (2d Cir. 2005) (EPA use of non-numerical effluent limitations in the form of BMPs are effluent limitations under the CWA); and Natural Res. Def. Council, Inc. v. EPA, 673 F.2d 400, 403 (D.C. Cir. 1982) (“section 502(11) [of the CWA] defines `effluent limitation' as ‘any restriction’ on the amounts of pollutants discharged, not just a numerical restriction.”))

EPA published the proposed rule on October 22, 2014, and took public comment through February 20, 2015. During the public comment period, EPA received approximately 200 comments. EPA also held a public hearing on November 10, 2014. Administrative burden was a concern of many of the commenters on the 2014 proposed rule, particularly from regulatory authorities responsible for oversight and enforcement of the new standard. Commenters also provided additional information on amalgam separators (e.g., costs, models, and design) as well as information on some other approaches to reduce pollutant discharges from dentists. Commenters also offered ways to improve and/or clarify the proposed pretreatment standards, including the proposed numerical efficiency and operation and maintenance requirements. See DCN DA00516 for these comments and EPA's responses.

Currently, 12 states (Connecticut, Louisiana,1 Maine, Massachusetts, Michigan, New Hampshire, New Jersey, New Mexico, New York, Rhode Island, Vermont, and Washington) have mandatory programs to reduce dental mercury discharges. Additionally, at least 18 localities (located in California, Colorado, Ohio, and Wisconsin) similarly have mandatory dental amalgam reduction pretreatment programs. EPA analyzed readily available information about these programs and found commonalities (DCN DA00524). For example, all require the use of amalgam separators and most specify associated operating and maintenance requirements. The majority of these programs also require some type of best management practices, and at least a one-time compliance report to the regulating authority.

The National Pretreatment Program requires industrial dischargers that discharge to POTWs to comply with pretreatment standards. The General Pretreatment Regulations in 40 CFR part 403 establish roles and responsibilities for entities involved in the implementation of pretreatment standards. This section summarizes the roles and responsibilities of Industrial Users (IUs), Control Authorities, and Approval Authorities. For a detailed description, see the preamble for the proposed rule (79 FR 63279-63280; October 22, 2014).

An IU is a nondomestic source of indirect discharge into a POTW, and in this rule is the dental discharger. The Control Authority may be the POTW, the state, or EPA, depending on whether the POTW or the state is approved by EPA to administer the pretreatment program. The Control Authority is the POTW in cases where the POTW has an approved pretreatment program. The Control Authority is the state, where the POTW has not been approved to administer the pretreatment program, but the state has been approved. The Control Authority is EPA where neither the POTW nor the state have been approved to administer the pretreatment program. The Approval Authority is the State (Director) in an NPDES authorized state with an approved pretreatment program; or the EPA regional administrator in a non-NPDES authorized state or NPDES state without an approved state pretreatment program.

Typically, an IU is responsible for demonstrating compliance with pretreatment standards by performing self-monitoring, submitting reports and notifications to its Control Authority, and maintaining records of activities associated with its discharge to the POTW. The Control Authority is the regulating authority responsible for implementing and enforcing pretreatment standards. The General Pretreatment Regulations require certain minimum oversight of IUs by Control Authorities. The required minimum oversight includes receipt and analysis of reports and notifications submitted by IUs, random sampling and analyzing effluent from IUs, and conducting surveillance activities to identify occasional and continuing non-compliance with pretreatment standards. The Control Authority is also responsible for taking enforcement action as necessary. For IUs that are designated as Significant Industrial Users (SIUs), Control Authorities must inspect and sample the SIU effluent annually, review the need for a slug control plan, and issue a permit or equivalent control mechanism. IUs subject to categorical pretreatment standards are referred to as Categorical Industrial Users (CIUs). The General Pretreatment Regulations define SIU to include CIUs. The Approval Authority is responsible for ensuring that POTWs comply with all applicable pretreatment program requirements. Among other things, the Approval Authority receives annual pretreatment reports from the Control Authority. These reports must identify which IUs are CIUs.

On November 6, 2013, the United States joined the Minamata Convention on Mercury, a new multilateral environmental agreement that addresses specific human activities that are contributing to widespread mercury pollution. The agreement identifies dental amalgam as a mercury-added product for which certain measures should be taken. Specifically, the Convention lists nine measures for phasing down the use of mercury in dental amalgam, including promoting the use of best environmental practices in dental offices to reduce releases of mercury and mercury compounds to water and land. Nations that are parties to the Convention are required to implement at least two of the nine measures to address dental amalgam. This final rule contributes to the U.S.'s efforts to meet the measures called for in the treaty.

The industry category affected by this final rule is Offices of Dentists (NAICS 621210), which comprises establishments of health practitioners primarily engaged in the independent practice of general or specialized dentistry, or dental surgery. These practitioners operate individual or group practices in their own offices or in the offices of others, such as hospitals or health maintenance organization medical centers. They can provide either comprehensive preventive, cosmetic, or emergency care, or specialize in a single field of dentistry.

According to the 2012 Economic Census, there are 133,221 U.S. dental offices owned or operated by 125,275 dental firms.2 Only 2 percent of all dental firms are multi-unit, the rest are single-unit. The growth of the number of dental offices remained steady over the past decade with an average increase of 1 percent per year.

The industry includes mostly small businesses with an estimated over 99 percent of all offices falling below the Small Business Administration (SBA) size standard ($7.5 million in annual revenue). Using Census Bureau data, EPA estimates an average revenue for offices at $787,190 per year with an average of 6.6 employees per establishment.

According to ADA data, approximately 80 percent of the dental industry engages in general dentistry. Approximately 20 percent are specialty dentists such as periodontists, orthodontists, radiologists, maxillofacial surgeons, endodontists, or prosthodontists (DCN DA00460).

Dentistry may also be performed at larger institutional dental offices (military clinics and dental schools). Since EPA does not know if these offices are included in the 2012 Economic Census data, EPA conservatively assumed the largest offices are not present in the data, and so added an estimate of 415 larger institutional dental offices across the nation. For the final rule, EPA updated this number based on comments received on the proposed rule.

Dental amalgam consists of approximately 49 percent mercury by weight. Mercury is the only metal that is in its liquid phase at room temperature, and it bonds well with powdered alloy. This contributes to its durability in dental amalgam. The other half of dental amalgam is usually composed of 35 percent silver, 9 percent tin, 6 percent copper, 1 percent zinc and small amounts of indium and palladium (DCN DA00131).

Sources of dental amalgam discharges generally occur in the course of two categories of activities. The first category of discharges may occur in the course of treating a patient, such as during the placement or removal of a filling. When filling a cavity, dentists overfill the tooth cavity so that the filling can be carved to the proper shape. The excess amalgam is typically rinsed into a cuspidor, or suctioned out of the patient's mouth. In addition to filling new cavities, dentists also remove old restorations that are worn or damaged. Removed restorations also may be rinsed into a cuspidor or suctioned out of the patient's mouth. Based on information in the record (DCN DA00456), removed restorations is the largest contributor of mercury in dental discharges.

The second category of dental amalgam discharges occurs in the course of activities not directly involved with the placement or removal of dental amalgam. Preparation of dental amalgam, disposing of excess amalgam, and flushing vacuum lines with corrosive chemicals present opportunities for dental amalgam to be discharged.

The use of dental amalgam has decreased steadily since the late 1970s as alternative materials such as composite resins and glass ionomers have become more widely available. Estimates show that placements of dental amalgam have decreased on average by about 2 to 3% per year (74 FR 38686; August 4, 2009). Based on this information, EPA estimates that mercury in dental amalgam discharges to POTWs will decrease by about half within the next 25 years. While the use of dental amalgam continues to decline, EPA estimates that approximately 2 tons of mercury would continue to be discharged to POTWs in 2040.

The typical plumbing configuration in a dental office consists of a chair-side trap for each chair, and a central vacuum pump with a vacuum pump filter. Chair-side traps and vacuum pump filters remove approximately 78 percent of dental amalgam particles from the wastewater stream (DCN DA00163). EPA identified three major technologies that capture dental amalgam waste, in addition to chair-side traps and vacuum pump filters, before it is discharged to the POTW: Separators, ion exchange, and wastewater containment systems. EPA also identified BMPs that have a significant impact on dental amalgam discharges.

An amalgam separator is a device designed to remove solids from dental office wastewater. Amalgam separators remove amalgam particles from the wastewater through centrifugation, sedimentation, filtration, or a combination of any of these methods. Practically all amalgam separators on the market today rely on sedimentation because of its effectiveness and operational simplicity.

The vast majority of amalgam separators on the market today have been evaluated for their ability to meet the current American National Standards Institute's (ANSI) Standard for Amalgam Separators (ANSI/ADA Standard No. 108 for Amalgam Separators). This standard incorporates the International Organization for Standardization (ISO) Standard for Dental Amalgam Separators (http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=42288).3 The current ISO standard for amalgam separators is ISO 11143. ISO established a standard for measuring amalgam separator efficiency by evaluating the retention of amalgam solids using specified test procedures in a laboratory setting. In order to meet the ISO standard, a separator must achieve 95 percent removal or greater of total solids. The ISO standard also includes certain design requirements and requirements for instructions for proper use and maintenance. For example, for non-sedimentation amalgam separators, the ISO 11143 standard requires a warning system such as an auditory or visual sign to indicate when the separator's efficiency is compromised to ensure that the operator is aware that the separator is not operating optimally. For sedimentation separators, the requirement can be met by providing instructions that would allow the operator to ascertain the operating status of the amalgam separator.

Based on reported removal efficiencies of a range of amalgam separators currently on the market that meet the ISO standard, separators obtain a median of 99 percent removal efficiency (see Chapter 7 of the TEDD) of total dental solids. When existing chair-side traps and vacuum pump filters are used upstream of the amalgam separators, the combined treatment system can achieve total mercury removal rates exceeding 99 percent (DCN DA00008).

Solids collected by the amalgam separator may be a combination of dental amalgam, biological material from patients, and any other solid material sent down the vacuum line. The collected solids must be handled in accordance with federal, state and local requirements. EPA regulates the disposal of mercury-containing hazardous waste under the Resource Conservation and Recovery Act (RCRA). A mercury-containing waste can be considered hazardous in two ways: (1) As a listed hazardous waste; or (2) as a characteristic hazardous waste. Unused elemental mercury being discarded would be a listed hazardous waste (waste code U151). Persons who generate hazardous waste, such as a waste that exhibits the hazardous characteristics for mercury, are subject to specific requirements for the proper management and disposal of that waste. The federal RCRA regulatory requirements differ depending upon how much hazardous waste a site generates per month. Most dental practices generate less than 100 kilograms of non-acute hazardous waste per month and less than 1 kilogram of acute hazardous waste per month. Such facilities are therefore classified as “Very Small Quantity Generators” (VSQGs). VSQGs are not subject to most of the RCRA hazardous waste requirements.

Many states have additional requirements for the handling of mercury, including waste dental amalgam. Chapter 6 of the TEDD provides additional details on the handling requirements for states that require dentists to control dental mercury dischargers. To facilitate compliance with state and local requirements, several amalgam separator manufacturers offer services that facilitate the transport of waste amalgam to facilities that separate mercury from other metals in dental amalgam and recycle the mercury, keeping it out of the environment. EPA recommends that dental dischargers take advantage of such services. In 2012, ADA posted a directory of amalgam recyclers on its Web site. See DCN DA00468.

For more information about amalgam separators, see the proposed rule (79 FR 63265; October 22, 2014).

Mercury from dental amalgam in wastewater is present in both the particulate and dissolved form. The vast majority (>99.6 percent) is particulate (DCN DA00018). An additional process sometimes referred to as “polishing” uses ion exchange to remove dissolved mercury from wastewater. Dissolved mercury has a tendency to bind with other chemicals, resulting in a charged complex. Ion exchange is the process that separates these charged amalgam particles from the wastewater. For ion exchange to be most effective, the incoming wastewater must first be treated to remove solids. Then the wastewater needs to be oxidized (creating a charge on the amalgam particles) in order for the resin or mercury capturing material to capture the dissolved mercury. Therefore, ion exchange will not be effective without first being preceded by a solids collector and an oxidation process. The data available to EPA indicate that total additional mercury reductions with the addition of polishing are typically about 0.5 percent (DCN DA00164). This is not surprising since, as indicated above, dissolved mercury contributes such a small portion to the total amount of mercury in wastewater. In addition to polishing as described above, EPA is aware that vendors are developing amalgam separators with an improved resin for removing dissolved mercury. For additional discussion on polishing, see proposal (79 FR 63266; October 22, 2014).

Commenters on the proposed rule identified wastewater retaining tanks as a third technology to reduce mercury discharges from dental offices to POTWs. Where currently used, these systems collect and retain all 4 amalgam process wastewater. The wastewater remains in the wastewater retention tank until it is pumped out of the tank and transferred to a privately owned wastewater treatment facility. This eliminates the discharge of amalgam process wastewater and the associated pollutants from a dental office to a POTW.

In addition to technologies, EPA also identified best management practices currently used in this industry (and included in the ADA BMPs) to reduce dental amalgam discharges. In particular, EPA identified two BMPs to control dental amalgam discharges that would not be captured by an amalgam separator and/or polishing unit. Oxidizing line cleaners can solubilize bound mercury. If oxidizing cleaners are used to clean dental unit water lines, chair side traps, or vacuum lines that lead to an amalgam separator, the line cleaners may solubilize any mercury that the separator has captured, resulting in increased mercury discharges. One BMP ensures the efficiency of amalgam separators by prohibiting use of oxidizing line cleaners including but not limited to, bleach, chlorine, iodine and peroxide, that have a pH lower than 6 or greater than 8.5

Flushing waste amalgam from chair-side traps, screens, vacuum pump filters, dental tools, or collection devices into drains also presents additional opportunities for mercury to be discharged from the dental office. The second BMP prohibits flushing waste dental amalgam into any drain.

Consistent with the proposal, dental offices that discharge to POTWs are within the scope of this final pretreatment rule.6 EPA solicited information in the proposal from the public on its preliminary finding that, with few exceptions, dental offices do not discharge wastewater directly to surface waters. EPA did not receive any comments containing data to contradict this finding. Therefore, EPA is not establishing any requirements for direct wastewater discharges from dental offices to surface waters at this time.

The final rule applies to wastewater discharges to POTWs from offices where the practice of dentistry is performed, including large institutions such as dental schools and clinics; permanent or temporary offices, home offices, and facilities; and including dental offices owned and operated by federal, state, or local governments including military bases. The final rule does not apply to wastewater discharges from dental offices where the practice of dentistry consists exclusively of one or more of the following dental specialties: Oral pathology, oral and maxillofacial radiology, oral and maxillofacial surgery, orthodontics, periodontics, or prosthodontics. As described in the TEDD, these specialty practices are not expected to engage in the practice of amalgam restorations or removals, and are not expected to have any wastewater discharges containing dental amalgam.

The final rule also does not apply to wastewater discharges to POTWs from mobile units. EPA proposed to apply the standards to mobile units (typically a specialized mobile self- contained van, trailer, or equipment from which dentists provide services at multiple locations), soliciting comments and data pertaining to them (79 FR 63261; October 22, 2014). However, EPA is not establishing requirements for mobile units at this time because it has insufficient data to do so. EPA does not have, nor did commenters provide, data on the number, size, operation, or financial characteristics of mobile units. EPA also has minimal information on wastewater discharges from mobile units, and/or practices employed to minimize dental amalgam in such discharges. Therefore, any further evaluation of requirements for mobile units is not possible at this time, and the final rule requirements do not apply to mobile units.

After considering all of the relevant factors and dental amalgam management approaches discussed in this preamble and TEDD, as well as public comments, EPA decided to establish PSES based on proper operation and maintenance of one or more ISO 11143 7 compliant amalgam separators and two BMPs—a prohibition on the discharge of waste (or “scrap”) amalgam to POTWs and a prohibition on the use of line cleaners that are oxidizing or acidic and that have a pH higher than 8 or lower than 6. EPA finds that the technology basis is “available” as that term is used in the CWA because it is readily available and feasible for all dental offices subject to this rule. Data in the record demonstrate that the technology basis is extremely effective in reducing pollutant discharges in dental wastewater to POTWs as the median efficacy of ISO compliant amalgam separators on the market in the U.S. is 99.3 percent. Moreover, ADA recommends that dentists use the technology on which this rule is based (ISO compliant amalgam separators and BMPs). Further, as described in Section III, EPA estimates that approximately 40 percent of dental offices potentially subject to this rule currently use amalgam separators on a voluntary basis or are in states or localities with laws requiring the use of amalgam separators. Many dentists have used amalgam separators and BMPs for at least a decade. For those dental offices that have not yet installed an amalgam separator, EPA estimates this is a low-cost technology with an approximate average annual cost of $800 8 per office. EPA's economic analysis shows that this rule is economically achievable (see Section IX). Finally, EPA also examined the incremental non-water-quality environmental impacts of the final pretreatment standards and found them to be acceptable. See Section XII.

EPA did not establish PSES based on technologies that remove dissolved mercury such as polishing. EPA is not aware of any state or local regulations that require ion exchange or that require removal of dissolved mercury. Commenters raised operational concerns with ion exchange citing a pilot study for the department of Navy. EPA also lacks adequate performance data to assess the efficacy of polishing for nationwide use. While even very small amounts of mercury have environmental effects, EPA lacks sufficient data to conclude that there is a significant difference in the performance between traditional amalgam separators and polishing. Moreover, current information suggests that polishing is not available for nationwide use because the typical dental office may not have adequate space to install the treatment train needed for effective polishing and because there are few polishing systems on the market today in comparison to traditional amalgam separators. Lastly, EPA estimates that the capital costs of the polishing system, as a stand-alone system, are approximately four times that of the amalgam separator even though the costs for chemical use, regenerating the resin, filter replacement, and other operational costs were not reported (DCN DA00122). These factors led EPA to find that polishing is not “available” as that term is used in the CWA.

EPA also did not establish PSES based on wastewater retention tanks. Capital costs for wastewater retention tanks are approximately twice that of the amalgam separator (DCN DA00461). EPA does not have information on the costs incurred by the dental office to send the collected wastewater off-site to a privately owned treatment facility (may also be referred to as a centralized waste treatment facility or CWT). Furthermore, wastewater retention tanks require space, and EPA determined that the typical dental office may not have adequate space to install the tanks. In addition, EPA is only aware of one vendor currently offering this technology and service combination (vendor transfers the collected wastewater to a privately owned treatment facility), and the vendor's service area is limited to a few states. Therefore, EPA did not find this technology to be available to the industry as a whole.

After considering all of the relevant factors and technology options discussed in this preamble and in the TEDD, as well as public comments, EPA decided to establish PSNS based on the same technologies identified above as PSES. As previously noted, under section 307(c) of the CWA, new sources of pollutants into POTWs must comply with standards that reflect the greatest degree of effluent reduction achievable through application of the best available demonstrated control technologies. Congress envisioned that new treatment systems could meet tighter controls than existing sources because of the opportunity to incorporate the most efficient processes and treatment systems into the facility design. The technologies used to control pollutants at existing offices, amalgam separators and BMPs, are fully available to new offices. In addition, data from EPA's record show that the incremental cost of an amalgam separator compared to the cost of opening a new dental office is negligible; therefore, EPA determined that the final PSNS present no barrier to entry (see Section IX below). Similarly, because EPA projects that the incremental non-water quality environmental impacts associated with controls for new sources would not exceed those for existing sources, EPA concludes the non-water quality environmental impacts are acceptable. Therefore, this final rule establishes PSNS that are the same as those for PSES.

EPA rejected other technologies as the basis for PSNS for the same reasons the Agency rejected other technology bases for PSES.

EPA finalized the performance standards based on the same technology identified in the proposed rule, amalgam separators.

EPA proposed a standard that would require dental dischargers to remove a specified percentage of total mercury from amalgam process wastewater and to follow the BMPs. Recognizing the impracticality of collecting and analyzing wastewater samples to demonstrate compliance with the standard for this industry, EPA included a provision by which dental offices could demonstrate compliance by certifying they were following the required BMPs and using an amalgam separator that achieved the specified percentage when tested for conformance with the ISO standard. EPA received comments regarding the proposed requirement. Commenters questioned the specified percent reduction, and raised concerns that the proposed standard could require dental offices to measure the percent removal being achieved by their amalgam separator, which was not the Agency's intent. In response to these comments, the final rule specifies a performance standard—BMPs and the use of an amalgam separator(s) compliant with the ISO standard rather than specifying a numerical reduction requirement. The final rule also includes a provision such that the performance standard can be met with the use of an amalgam removing technology other than an amalgam separator (equivalent device). EPA included this provision to incorporate future technologies that achieve comparable removals of pollutants from dental discharges as amalgam separators but that may not fall under the amalgam separator classification. Because the rule does not include a numerical limit, the performance standards also specify certain operation and maintenance requirements for the amalgam separator or comparable device to ensure they are operated optimally.

The final rule allows dental offices to continue to operate existing amalgam separators for their lifetime or ten years (whichever comes first), as long as the dental discharger complies with the other rule requirements including the specified BMPs, operation and maintenance, reporting, and recordkeeping requirements. Once the separator needs to be replaced or the ten-year period has ended, dental offices will need to replace the amalgam separator with one that meets the requirements of the final rule. EPA does not want to penalize existing dental offices or institutional dental offices that have already installed amalgam separators voluntarily or to comply with state or local requirements. EPA recognizes that these offices may currently have amalgam separators in place that do not meet the ANSI ADA specification or the criteria of the ISO 11143 2008 standard. EPA did not want to establish a rule that would require dental offices with existing separators that still have a remaining useful life to be retrofitted with new separators, both because of the additional costs incurred by dental offices that adopted technology to reduce mercury discharges ahead of EPA's requirements and because of the additional solid waste that would be generated by disposal of the existing separators.

In addition to installing one or more amalgam separators compliant with the ISO 11143 standard (or its equivalent) and implementing the required BMPs, the pretreatment standards specify certain operating and maintenance requirements for the amalgam separator. For example, the final rule requires a documented amalgam separator inspection to ensure the separator is performing properly. As explained in Section V, malfunctioning separators or separators that have reached their capacity are ineffective. Therefore, in order to ensure that mercury is not discharged from the facility, it is important that dentists know the operational status of their amalgam separator (see 40 CFR 441.40(c)). As such, the final rule requires the separator to be inspected per the manufacturer's instructions. In addition, as explained in Section V, the ISO standard specifies non-sedimentation separators must have a visual or auditory warning indicator when the separator is nearly full or operating in by-pass mode. While not required for sedimentation amalgam separators, some manufacturers of sedimentation amalgam separators include visual or auditory warning indicators. Because warning indicators make it easy to detect when the separator is not operating optimally, EPA encourages dental offices to select an amalgam separator with a warning indicator when installing a new amalgam separator.

EPA is aware that some amalgam separator vendors (in addition to providing the needed equipment) or service providers offer service contracts to maintain the system. These vendors also typically provide waste management services for the collected solids. Some vendors also provide the necessary documentation and reports required by existing state and local programs. EPA encourages but does not require dental offices to consider such services, as they may aid compliance with the rule.

In the final rule, dental dischargers that do not place dental amalgam, and do not remove dental amalgam except in limited emergency or unplanned, unanticipated circumstances are exempt from any further requirements as long as they certify such in their One-time Compliance Report to their Control Authority. In this way, if, over time, the use of dental amalgam is phased out as a restorative material, the requirements of this rule will no longer apply. By limited circumstances, EPA means, dental offices that remove amalgam at a frequency less than five percent of its procedures. As described below, based on the record, on average, this percent approximates to 9 removals per office per year (DCN DA00467).

Dental amalgam traditionally has been used as a restorative material for cavities because the malleability of newly mixed amalgam makes it easy to place into cavities and because of its durability over time. While still used in many dental offices in the U.S., some dental offices have elected not to use dental amalgam and instead use only non-mercury based filling materials, such as composite resins and glass ionomer cements (DCN DA00495). As explained in Section IV, removed restorations are the largest contributor of mercury in dental discharges. Some dental offices have also elected not to remove amalgam restorations.

EPA recognizes some dental offices only remove dental amalgam extremely infrequently, where there is an unplanned, unanticipated procedure. At the same time, for accepting new patients during the normal course of business, EPA would expect offices to inquire as to whether the patient has mercury fillings and not accept patients that have such fillings unless they install a separator or equivalent treatment in accordance with this rule. EPA proposed that dental offices that certify that they do not place or remove amalgam except in limited emergency circumstances would be exempt from any further requirements of the rule. EPA is clarifying in the final rule that the limited circumstances provision applies to the removal, but not to the placement of dental amalgam. A dental office that stocks amalgam capsules clearly intends to place amalgam, and does not represent the type of limited circumstance this provision is intended to address. Commenters largely supported this approach, and most commenters suggested EPA define limited emergency circumstances. The frequency recommended by these commenters ranged from once a quarter to 96 times a year (DCN DA00467).

EPA is including the limited circumstances provision in the final rule to allow a dental office that does not reasonably expect to place or remove dental amalgam to provide immediate treatment, such as where unplanned, unanticipated removal of the amalgam is necessary at that facility at that time, in the professional judgment of the dentist. EPA's intent is to exclude dental offices from the rule's requirements, other than a one-time report, for unplanned removals. In EPA's view, dental offices that remove amalgam at a frequency more often than five percent of its procedures are not likely engaging in only limited, unplanned removals. EPA estimates that on average, a single chair dental office would remove amalgam 183 times per year (DCN DA00467). An amalgam removal rate that represents less than five percent of this frequency consists of approximately nine removals per year, on average, respectively. However, because EPA does not have, nor did commenters provide, data on the frequency of such unplanned and unanticipated instances nationwide, the final rule does not include a specific definition of limited circumstances. Rather, EPA expects a dental office to carefully consider its operation in light of the information provided above and only certify accordingly to their Control Authority if it meets the situation EPA described.

Dental dischargers subject to this rule must comply with a one-time reporting requirement specified in the final rule in lieu of the otherwise applicable reporting requirements in 40 CFR part 403. Submission of reports as specified in this rule satisfies the reporting requirements in 40 CFR parts 403 and 441. For dental offices that do not place or remove dental amalgam except in limited circumstances, dental offices must submit a One-Time Compliance Report that includes information on the facility and a certification statement that the dental discharger does not place dental amalgam and does not remove amalgam except in limited circumstances. For dental offices that place or remove dental amalgam, the One-Time Compliance Report must include information on the dental facility and its operations and a certification that the dental discharger meets the requirements of the applicable performance standard. Dentists that utilize a third party to maintain their separator must report that information in their One-Time Compliance Report. Dentists that do not utilize a third party to maintain the amalgam separator(s) must provide a description of the practices employed by the office to ensure proper operation and maintenance. EPA suggests dental offices consider use of signs displayed prominently in the office or electronic calendar alerts to remind staff of dates to perform and document monthly inspections, cartridge replacement, etc.

If a dental practice changes ownership (which is a change in the responsible party, as defined in 40 CFR 403.12(l)), the new owner must submit a One-Time Compliance Report that contains the required information.

The One-Time Compliance Report must be signed by (1) a responsible corporate officer if the dental office is a corporation; (2) a general partner or proprietor if the dental office is a partnership or sole proprietorship; or (3) a duly authorized representative of the responsible corporate officer, or general partner or proprietor. This does not preclude a third party from submitting the report on behalf of a dental office as long as the submission also includes a proper signature as described above.

The final rule does not require electronic reporting nor does it prevent electronic reporting. EPA received several comments requesting that EPA develop an electronic compliance reporting system as a part of this final rule. These commenters generally advocated for electronic reporting due to the size of the industry and the proposed annual reporting requirement. During development of the final rule, EPA considered several variations of requirements for dental dischargers to report electronically (which would have necessitated an electronic system). Most commonly, electronic systems are preferable when reports must be submitted on a periodic basis. EPA ultimately decided not to specify electronic reporting in the final rule after it determined the final rule would only require a one-time compliance report from each affected dental discharger.

Still, EPA recognizes that some Control Authorities may prefer to receive the one-time reports electronically or to provide affected dental dischargers with the option to report electronically. EPA also recognizes that electronic submittal of required reports could increase the usefulness of the reports, is in keeping with current trends in compliance reporting, and could result in less burden on the regulated community and the Control Authorities. EPA may develop and make available, via its E-Enterprise portal, an electronic reporting system that Control Authorities could use to facilitate the receipt of reports from dental dischargers, if they choose to do so. At some future date, EPA could decide to revise this final rule to require electronic reporting. If it chose to do so, EPA would first propose the revisions and provide an opportunity for public review and comment.

Finally, the final rule requires dental offices to document certain operation and maintenance requirements and maintain all records of compliance, as described in the regulation, and to make them available for inspection.

EPA proposed to amend selected parts of the General Pretreatment Regulations (40 CFR part 403) in order to simplify oversight requirements for the approximately 117,000 dental offices subject to the proposed rule. Specifically, EPA proposed to amend 40 CFR part 403 to create a new classification of categorical industrial users specifically tailored to pretreatment standards for dental offices, dental industrial user (DIU). EPA proposed that as long as a dental office complied with the requirements for DIUs, that it would not be considered an SIU. Among other things, this would have reduced the General Pretreatment Regulation oversight requirements for Control Authorities, such as the requirement to issue a control mechanism and annual inspection and sampling.

EPA received numerous comments related to the proposed change, particularly from the Control Authorities. These commenters largely supported the reduced oversight requirements in the proposal, but encouraged EPA to reduce them further so that dental offices would never be SIUs, primarily due to concerns over the associated burden given the large number of dental offices potentially subject to the rule. In addition, Control Authorities raised concerns that they would have to update state and local laws to take advantage of the proposed changes to part 403 that would reduce the oversight requirements. They also raised concerns about additional reporting requirements for the Control Authorities typically associated with CIUs, such as identifying CIUs in their annual pretreatment report to the Approval Authority.

In response, EPA did not revise the General Pretreatment Standards to create the proposed DIU category and associated requirements. Rather, this rule establishes for the purposes of part 441, that dental dischargers are not SIUs or CIUs as defined in 40 CFR part 403 unless designated as such by the Control Authority. This regulatory structure achieves the same goal as the proposed revisions to the General Pretreatment Standards—simplification of oversight requirements—without creating a need for updates to state and local laws. By establishing that dental dischargers are not SIUs or CIUs in the final rule, EPA eliminates the application of specific oversight and reporting requirements in 40 CFR part 403 such as permitting and annual inspections of dental dischargers for SIUs and CIUs unless the Control Authority chooses to apply these requirements to dental offices. This means that Control Authorities have discretion under the final rule to determine the appropriate manner of oversight, compliance assistance, and enforcement.9 Further, the final rule reduced reporting for dental offices (and associated oversight requirements by Control Authorities) in comparison to reporting requirements for other industries subject to categorical pretreatment standards, as it requires only a One-Time Compliance Report be submitted to the Control Authority. The One-Time Compliance Report requirements specific to dental dischargers are included in this rule rather than in the General Pretreatment regulations so that they may be implemented directly. In summary, for this final rule, the Control Authorities must receive the One-Time Compliance Reports from dental dischargers and retain that notification according to the standard records retention protocol contained in § 403.12(o).

Where EPA is the Control Authority, EPA expects to explore compliance monitoring approaches that support sector-wide compliance evaluations, to the extent practicable. States and POTWs that are the Control Authority may elect to use the same approach but are not required to do so. One approach may be periodic review and evaluation of nationwide data on releases of dental amalgam metals (e.g., mercury), relying on Discharge Monitoring Reports from POTWs, Annual Biosolids Reports from POTWs, emissions data from sludge incinerators, and supplemental data submitted to EPA under the Toxic Releases Inventory program. EPA may utilize an approach to compliance inspections that focuses on a statistically valid sample of the regulated community. EPA may then use the inspection findings from such an approach to identify common areas of noncompliance, which would inform decisions about needed outreach, compliance assistance, and training materials. EPA will work with state and local Control Authorities, the ADA and other partners to tailor oversight and outreach to the issues where such oversight and outreach is most likely to achieve compliance across the dental sector.

The final rule applies to both dental offices that are subject to existing mandatory state or local dental amalgam reduction programs and those that are not. Some proposal commenters, many of whom are in states and localities with existing programs, questioned the application of this rule to dentists already subject to state and local programs noting the duplicative requirements. While EPA found that many of the existing programs contained at least one attribute of this final rule (e.g. separators, reporting, BMPs, operation and maintenance), the majority did not contain all of the attributes. Generally, the additional requirements (and associated costs) of this final rule are incremental over existing mandatory state or local dental amalgam reduction requirements. For example, a dentist located in a state or locality that does not require one or both of the BMPs specified in this rule must implement both BMPs. While the requirements of this rule are incremental to existing state and local regulatory requirements, EPA finds they are necessary to achieve the intended environmental objectives of the rule. Applying categorical pretreatment standards to pollutant discharges from dental offices irrespective of existing discharge requirements is consistent with the general approach to pretreatment standards under the CWA in that it establishes uniform requirements that form the floor of performance for all dischargers in a regulated category.

In addition, requiring all dental offices to meet the same requirements, regardless of the applicability of other state or local requirements, avoids substantial implementation challenges and potential confusion associated with alternative approaches. EPA considered several approaches for accommodating dentists in states and localities with existing and local requirements. For example, EPA considered exempting dentists subject to equivalent state and local requirements from the scope of this rule. EPA rejected this approach, in part, due to the complexities and potential confusion associated with evaluating and communicating the equivalency of state and local requirements to this rule, particularly as they may change over time.

The rule establishes clear requirements for all parties and compliance with the final rule is simple and straightforward for dental offices and the regulating authorities. It requires dental offices to install and operate a separator, to implement two BMPs, and to submit a One-time Compliance Report to the Control Authority. Thereafter, the dental office will be required to conduct ongoing operation and maintenance and maintain associated records. These activities can be facilitated by third parties such as dental office suppliers and amalgam separator manufacturers. EPA does not expect the federal requirements to conflict with existing state or local mandatory amalgam reduction requirements. Rather, EPA concludes this final rule imposes only incremental additional requirements (e.g., one-time compliance report) to their Control Authority, if any, on dental offices already subject to state or local amalgam reduction requirements. For Control Authorities, because EPA significantly reduced the oversight requirements associated with this rule, the incremental costs and burden to apply the final rule's requirements to dental facilities subject to some existing mandatory dental amalgam reduction requirements are minimal. The only incremental requirement associated with this rule is for the Control Authority to receive, review, and retain a One-time Compliance Report from dentists subject to this rule.

The provision of this rule establishing that dental dischargers are not SIUs or CIUs unless designated as such by the Control Authority does not change the otherwise applicable variances and modifications provided by the statute. For example, EPA can develop pretreatment standards different from the otherwise applicable requirements for an individual existing discharger subject to categorical pretreatment standards if it is fundamentally different with respect to factors considered in establishing the standards applicable to the individual discharger. Such a modification is known as a “fundamentally different factors” (FDF) variance. See 40 CFR 403.13 and the preamble to the proposed rule (79 FR 63278-63279, October 22, 2014). FDF variances traditionally have been available to industrial users subject to categorical pretreatment standards. Whether or not a dental discharger is an SIU or CIU, it is subject to categorical pretreatment standards and therefore eligible to apply for an FDF variance.

CWA section 301(b) directs EPA to eliminate the discharge of all pollutants where it is technologically available and economically achievable (after a consideration of the factors specified in section 304(b) of the Act). The first step in such an analysis is typically to identify Pollutants of Concern (POCs)—or the pollutants potentially regulated in the effluent guideline. For this rule, EPA identifies the primary metals in dental amalgam as pollutants of concern: Mercury, silver, tin, copper, and zinc.

Generally, in determining whether pollutants pass through a POTW when considering the establishment of categorical pretreatment standards, EPA compares the median percentage of the pollutant removed by POTWs achieving secondary treatment with the median percentage of the pollutant removed by facilities meeting BAT effluent limitations. EPA deems a pollutant to pass through a POTW when the percentage removed by POTWs is less than the percentage removed by direct dischargers complying with BPT/BAT effluent limitations. In this manner, EPA can ensure that the combined treatment at indirect discharging facilities and POTWs is at least equivalent to that obtained through treatment by a direct discharger, while also considering the treatment capability of the POTW. In the case of this final rulemaking, where EPA is only developing pretreatment standards, EPA compares the POTW removals with removals achieved by indirect dischargers using the technology that otherwise satisfies the BAT factors.

Historically, EPA's primary source of POTW removal data is its 1982 “Fate of Priority Pollutants in Publicly Owned Treatment Works” (also known as the 50 POTW Study). This well documented study presents data on the performance of 50 POTWs achieving secondary treatment in removing toxic pollutants. As part of the development of ELGs for the Centralized Waste Treatment (CWT) Industry promulgated in December 2000, EPA developed and documented a methodology, including data editing criteria, to calculate POTW percent removals for various toxic pollutants from the data collected in the study. EPA provided the opportunity for public comment on the percent removal methodology and the resulting percent removals in the CWT proposal. EPA similarly used and presented this methodology and data in subsequent ELG proposals and final rules. Using its long-standing approach, for this final rule, EPA determined the median percent removal by POTWs achieving secondary treatment is 90.2 percent for total mercury, and 42.6 percent to 88.3 percent for the other pollutants of concern.

As described above, the 50 POTW Study measured pollutant reductions on the basis of total metals. Total metals include particulate (suspended) and dissolved (soluble) forms of the metal. As discussed above, while mercury is present in dental amalgam in both the particulate and dissolved form, the vast majority (>99.6 percent) is particulate. While EPA does not have information on the distribution of the other metals, EPA reasonably assumes the same distribution for the other metals. Because secondary treatment technologies are not designed to remove dissolved metals, EPA assumes dissolved metals are not removed by POTWs and that the percent reductions for POTWs represent particulate reductions.

To determine the median percent removal of the pollutants of concern by amalgam separators, EPA collected information on the efficacy of existing separators. EPA excluded those separators that did not meet the 2008 ISO standards. At proposal, EPA determined the median percent removal of total mercury to be 99.0 percent, which is the reported removal when testing each of the amalgam separators marketed in the U.S. as conforming to the ISO standard (DCN DA00233). Commenters noted that existing data on the effectiveness of separators is measured as a percent reduction in mass, reflecting the dental amalgam particulates (rather than total mercury) collected by the device. EPA agrees the ISO standard evaluates particulates from dental amalgam rather than total mercury, and has adjusted its terminology accordingly. Based on updated information in the record, EPA determined the median percent removal of particulates by amalgam separators that meet the 2008 ISO standards is 99.3 percent. As such, because the median percent removal of amalgam separators exceeds the median percent removal of well-operated POTWs employing secondary treatment for mercury and the other POCs, EPA determines that mercury and the other POCs pass through.

In addition to comments relating to dissolved mercury, EPA received other comments and data pertaining to the proposed median percent removal of ISO compliant amalgam separators. Some commenters supported the percentage identified in the proposal, noting that certain states require the same level of performance, or identifying separators documented as achieving or exceeding that removal efficiency. Other commenters questioned EPA's use of the data collected when laboratories certify amalgam separators to meet the ISO standard. More specifically, they asserted that the 2008 ISO standard requires the removal efficiency of the amalgam separator to be at least 95 percent on a mass fraction basis and as such, the ISO standard is not a validated test for measuring higher efficiencies. These commenters offered no data to demonstrate that the reported removals in excess of 95 percent were inaccurate, nor did commenters provide other efficiency data for amalgam separators. As it represents the best data available for the final rule, EPA appropriately used the data as reported to estimate the efficacy of amalgam separators for these purposes. EPA notes that even if commenters correctly characterized the minimum percent removal efficiency of amalgam separators meeting the 2008 ISO standard as 95 percent, this is a higher removal rate than the median percent removal by POTWs for all POCs. Therefore, while EPA based its analysis in the final rule on the percent removals as reported, under either case, EPA determines that mercury and the other POCs pass through.

Other commenters stated the 50 POTW Study data were old, and that current POTW removals are higher than 90 percent. Some provided case studies, many of which reflected POTWs with advanced treatment capabilities rather than secondary treatment. In particular, the National Association of Clean Water Agencies (NACWA) submitted data from a nationwide voluntary survey of its members regarding mercury reductions at POTWs. Based on its analysis of the data collected in this survey, NACWA calculated a three-year average removal efficiency of 94 percent.10 EPA notes that even if EPA were to accept these data and analyses as presented by NACWA without further review, it would confirm EPA's conclusion that pass through of POCs occurs because this percentage is less than the median efficiency of 2008 ISO compliant amalgam separators of 99.3 percent.

EPA, however, gave full consideration to the NACWA survey and subjected the mercury influent and effluent data from the 41 POTWs from that survey to similar review and data editing criteria as influent and effluent data collected for the 50 POTW Study. In this way, EPA attempted to give the NACWA data full and equal consideration as the historical data from the 50 POTW Study. EPA created a database of the raw data in order to conduct its analysis. (DCN DA00463). When EPA calculated the median percent removal of the non-edited raw data as submitted by NACWA, the median plant performance was 93.8 percent, with a range of 57.2 percent to 99.1 percent. In reviewing the data used in that calculation, EPA identified numerous data points that would not satisfy the data editing criteria applied in the 50 POTW Study, including data points representing combined data rather than raw data, order of magnitude outlier concentrations, and incorrectly reported units of measure. Other discrepancies between data and analyses from the 50 POTW Study and NACWA survey include upward bias of using data from voluntary respondents, representing non-detect influent concentrations as zero,11 inclusion of several POTWs using BNR (biological nutrient removal) and other advanced treatment expected to perform better than secondary treatment, overrepresentation of areas with existing dental amalgam reduction programs, and underrepresentation of certain geographical areas. Sensitivity analyses around these data are found in the record. (DCN DA00464).

Consequently, for all of the reasons identified above, for this final rule, EPA finds that data from the 50 POTW Study continues to represent the best data available to determine the percent removed nationwide by well operated POTWs employing secondary treatment. Based on the information in its record including full consideration of comments, EPA appropriately concludes that the median percent removal of amalgam separators is higher than the median percent removal of POTWs for mercury and the other pollutants of concern. As such, EPA concludes mercury and the other POCs pass through.

This section summarizes EPA's approach for estimating incremental compliance costs to implement changes associated with this rule, while the TEDD provides detailed information on the methodology. The costing methodology for the final rule is the same as that described in the proposal (79 FR 63269; October 22, 2014); however, EPA updated some of the specific data elements. EPA estimated compliance costs using data collected through EPA's Health Services Industry Detailed Study (August 2008) [EPA-821-R-08-014], a review of the literature, information supplied by vendors, and data submitted with comments on the proposed rule. In estimating the total cost of the regulatory options, EPA estimated costs for the following components: Capital costs and other one-time costs; installation costs; annual operation and maintenance costs; and recordkeeping and reporting costs. EPA incorporated information received in comments pertaining to specific elements of the cost analysis, resulting in an increase in the initial installation cost and a minor increase in the average costs of dental amalgam separators that meet the 2008 ISO standard. In addition, EPA adjusted the reporting and recordkeeping costs to reflect the final rule requirements.

The cost estimates reflect the incremental costs attributed only to this final rule. For example, offices required by a state or local program to have an amalgam separator compliant with the 2008 ISO 11143 standard will not incur costs to retrofit a separator as a result of this rule. Others may certify that they do not place or remove amalgam. Such offices may still have costs under this final rule such as those associated with the one-time reporting requirement to certify that they do not place or remove amalgam. EPA's cost methodology assumes dental offices would use the required BMPs in combination with 2008 ISO 11143 amalgam separators to comply with the rule. All final cost estimates are expressed in terms of 2016 dollars.

EPA used a model office approach to calculate costs of this rule. Under this approach, EPA developed a series of model dental offices that exhibited the typical characteristics of the regulated dental offices, and then calculated costs for each type of model office. EPA then determined how many of each model office accurately represented the full universe of affected offices. While this part of the methodology remains unchanged from the proposal, EPA updated the number of offices in each model to reflect current existing state and local programs and, in the case of very large offices, to reflect new data obtained in public comments on the number of clinics and schools subject to this rule.

EPA used the model approach to estimate costs for offices that place or remove amalgam for this final rule. EPA developed compliance costs for seven models, where each model is based on the number of chairs in an office. The ranges for each model are as follows: 1 to 2 chairs, 3 chairs, 4 chairs, 5 chairs, 6 chairs, 7-14 chairs (average of 10 chairs), and 15 chairs. EPA developed the 15 chairs model specifically to represent large institutional offices. This is discussed separately below in Section VII.B. EPA developed two sets of costs for each model: One for offices that do not use an amalgam separator and one for offices that do use an amalgam separator.

For those offices that currently do not use an amalgam separator, EPA estimated one-time and annual costs. One-time costs include purchase of the separator and installation, and preparation of the One-time Compliance Report. Annual costs, for those offices that do use an amalgam separator, include visual inspection, replacement of the amalgam-retaining unit (e.g., cartridge or filter), separator maintenance and repair, recycling (preparation and services), and recordkeeping. Recordkeeping costs include documentation of inspection, separator maintenance and repair, and recycling (preparation and services). EPA also estimated periodic recordkeeping costs associated with repairs and One-Time Compliance Reports for new offices, which are included in the total of recordkeeping costs. Annual costs also include a cost offset, reflecting a cost savings as a result of changes that occur in the dental office due to the final rule requirements. More specifically, EPA received data in comments that an amalgam separator would protect the vacuum system filter and impeller blade from small particles, resulting in less frequent replacement and servicing of these elements when an amalgam separator has been installed. In the final rule cost analysis, EPA accordingly reduced the overall operation and maintenance costs for those dental offices that do not already have an amalgam separator. This cost offset reflects the reduced cost to dental offices of servicing the vacuum system filter and impeller blade. A summary of costs for dental offices that do not currently use amalgam separators may be found in Tables VII-1 and VII-2, see the TEDD for more details.

For those offices that already have an amalgam separator, EPA calculated costs for certain incremental annual costs associated with the amalgam separator required for this rule. Because these offices have separators, EPA only included a one-time cost for a One-Time Compliance Report ($23/office). Annual costs for such offices include visual inspection, replacement of the amalgam-retaining unit, separator maintenance and repair, recycling (preparation and services), and recordkeeping. Because these offices have amalgam separators in place, they are already incurring the majority of these costs irrespective of this final rule. As such, for those components (e.g., replacement of the cartridge and operation and maintenance), EPA calculated their incremental costs as a portion (percentage) of annual costs for dental offices without technology in place. Recordkeeping costs include documentation of inspection, separator maintenance and repair, and recycling (preparation and services). EPA also estimated periodic recordkeeping costs associated with repairs and One-Time Compliance Reports for new offices, which are included in the total of recordkeeping costs. EPA did not include the cost offset in this model, as described above. A summary of these annual costs may be found in Table VII-3, see the TEDD for more details.

In assessing the long term costs of rule compliance for these model offices (those with and without existing separators), EPA assumed that amalgam separators would have a service life of 10 years, at which time the amalgam separators would need to be replaced (DCN DA00163). Furthermore, the cost model assumes all dental amalgam separators installed prior to this rule would need to be replaced within 10 years of the effective date of this rule. Therefore, for the purposes of estimating compliance costs, EPA assumed that all offices subject to this rule would incur the cost of installing a new amalgam separator 10 years after the effective date of this rule. However, because various modifications needed by the office for initial amalgam separator installation would have already been completed, EPA has projected the installation costs for amalgam separators would be one-half of the cost of the original installation. EPA assumed that all dental offices would continue to incur recurring expenses such as O&M beyond year 10 in the same way as described for the initial installation. To the extent dental offices either close or certify they no longer remove or place amalgam, the costs are likely overstated.

EPA projects that there will be no incremental costs associated with the required BMPs because (1) costs for non-oxidizing, pH neutral line cleaners are roughly equivalent to other line cleaners; and (2) dental offices will not incur additional costs by changing the location for flushing waste amalgam.

Institutional dental offices (e.g., military clinics or dental schools) have a larger number of chairs than the typical dental office. For these institutional dental offices, EPA developed a costing methodology based on the methodology for offices described above. For purposes of costs, consistent with the proposal, EPA assumed the average institutional office has 15 chairs.15 As shown in Chapter 9 of the TEDD, EPA has cost information for five amalgam separators that have a maximum design ranging from 17-22 chairs. EPA also has costs for a unit that can be custom sized for chair sizes of 16 or greater. EPA used the information for these six separators to estimate costs for institutional facilities. See DCN DA00454. These costs are likely overstated as they do not reflect opportunities the largest offices may have to share costs,16 and they do not assume any economies of scale. In addition, it is possible that the largest offices have multiple plumbing lines, allowing the installation of dental amalgam separators (or equivalent devices) only for those chairs used for placing or removing amalgam. See the proposed preamble and the TEDD for additional details on the costing methodology for institutional offices.

As was the case for costing, EPA does not have office-specific discharge data for the approximately 117,000 dental offices potentially subject to this rule. Instead, EPA modeled the baseline, pre-rule discharges of mercury based on nationwide estimates of amalgam restorations and removals, and did not calculate the pollutant reductions on a per office basis. Rather, EPA calculated average mercury loadings by dividing the total number of annual procedures by the total number of dentists performing the procedure.17 The technology basis used to estimate the compliance costs of this rule includes 2008 ISO 11143 amalgam separators available on the market today, and certain BMPs. The median performance of these separators is 99.3 percent. EPA assumes all offices have chair-side traps or a combination of chair-side traps and vacuum filters that result in 68 percent and 78 percent collection of dental amalgam, respectively (DCN DA00163). After accounting for mercury reductions achieved through existing chair-side traps and vacuum pump filters, EPA's analysis reduces remaining mercury loads to reflect the combination of chair-side traps, vacuum filters, and amalgam separators. Therefore, EPA assumed a post-rule reduction in mercury loads to POTWs based on a 99.8 percent removal rate. This is the same approach and data that EPA presented in the proposal (79 FR 623275; October 22, 2014).

Amalgam is comprised of roughly 49 percent mercury, 35 percent silver, 9 percent tin, 6 percent copper and 1 percent zinc (DCN DA00131). As explained earlier in Section VI, EPA concludes that the technology basis would be equally effective in reducing discharges of silver, tin, copper, and zinc as it is in reducing mercury. EPA therefore applied the same approach to estimating reductions of other metals found in dental amalgam. In other words, EPA assumes chair-side traps and the combination of chair-side traps and vacuum filters will result in 68 percent and 78 percent collection of these metals, respectively. Remaining amalgam metals are further reduced by an amalgam separator, as discussed above.

EPA estimates the approximately 55,000 offices that install separators would obtain 99.3 percent removal of particulate mercury through the use of amalgam separators (median removal efficiency of amalgam separators; see Chapter 7 of the TEDD). This would result in reduction of particulate mercury discharges to POTWs by approximately 5.1 tons. Amalgam separators are not effective in removing dissolved mercury. However, dissolved mercury accounts for much less than 1 percent of the total mercury, so the form of mercury removed from discharges to POTWs is assumed to consist of particulate (solids) only.

As explained earlier in Section VI, EPA concludes that the technology basis for this final rule would be equally effective in reducing discharges of silver, tin, copper, and zinc as it is in reducing mercury. Accordingly, EPA estimates a reduction of these metal discharges to POTWs of approximately 5.3 tons.

EPA estimates this final rule would annually reduce particulate mercury and other metal particulate discharges by a total of 10.3 tons.

In order to evaluate final discharges of mercury (and other metals) to waters of the U.S. by the POTW, EPA used its 50 POTW Study to calculate POTW removals of each metal. As explained above, at baseline and prior to implementation of this rule, EPA estimates 5.1 tons of dental mercury particulates are collectively discharged annually to POTWs. Based on the 50 POTW Study, EPA estimates POTWs remove 90.2 percent of dental mercury from the wastewater. Thus, POTWs collectively discharge 1,003 pounds of mercury from dental amalgam to surface waters annually. Under this final rule, 99.8 percent of mercury particulates currently discharged annually to POTWs will be removed prior to the POTW. The POTWs then further remove 90.2 percent of the remaining particulate mercury from the wastewater. This reduces the total amount of dental mercury particulates discharged from POTWs nationwide to surface water to 11 pounds of mercury annually. In other words, discharges of dental mercury to waters of the U.S. from POTWs are expected to be reduced by 992 pounds per year.19 Similarly, EPA's 50 POTW Study data shows 42.6 percent to 88.3 percent of other metals in the wastewater are removed by POTWs. As explained above, EPA estimates 5.3 tons of other metals are also collectively discharged annually from dental offices to POTWs. Thus, POTWs collectively discharge approximately 2,178 pounds of other dental metals to surface waters annually. Following compliance with this rule, the total amount of other dental metal discharges from POTWs nationwide to surface waters will be approximately 24 pounds or a reduction of 2,153. See Chapter 11 of the TEDD for more details.

This section summarizes EPA's assessment of the total annual costs and impacts of the final pretreatment standards on the regulated industry.

As described earlier in Section VI of this preamble, EPA based the technology standard for the final rule on a widely available technology, amalgam separators, and employment of readily available BMPs. Section VII provides a detailed explanation of how EPA estimated compliance costs for model dental offices. As applicable, EPA annualized the capital costs over a 20-year period at a discount rate of 7 percent and 3 percent 20 and summed these costs with the O&M and reporting/recordkeeping costs to determine an annual compliance cost estimate for each model facility. See the TEDD for more details.

In order to develop a national estimate of social costs 21 based on these model offices, EPA estimated the number of dental offices represented by each model office. EPA categorized dental offices based on the number of chairs in each office.22 The 2012 Economic Census does not provide information on the distribution of dental offices by the number of chairs in each office. However, two studies, the ADA National Study and a Colorado Study, estimate distribution of dentist offices by number of chairs (DCN DA00141 and DCN DA00149). EPA used these two data sources to correlate the number of chairs per office to the revenue range of dental offices. EPA averaged the correlation of these two studies to estimate the number of dental offices by the number of chairs. The results are reported in table IX-1:

To estimate nationwide social costs, EPA multiplied the estimated total annualized costs of rule compliance for each model office by the estimated number of dental offices represented by that model (i.e. with the indicated number of chairs and with/without existing amalgam separators). In EPA's analysis, for dental offices that do not place or remove amalgam, EPA assigned them costs for a baseline-compliance report. EPA then summed the values for each chair range over the number of chair ranges to yield the total estimated compliance cost. Similarly, EPA calculated costs for institutional offices by multiplying the compliance cost for its model institutional offices (15-chair model) by the number of estimated institutional offices indicated in Section V. Lastly, EPA estimated costs for Control Authorities to administer the final rule. Details of this cost analysis can be found in the TEDD. See Table IX-2 for EPA's estimate of total nationwide annualized social costs for this final rule using a 3 percent discount rate.23

EPA devised a set of tests for analyzing economic achievability. As is often EPA's practice, the Agency conducted a cost-to-revenue analysis to examine the relationship between the costs of the rule to current (or pre-rule) dental office revenues as a screening analysis. In addition, EPA chose to examine the financial impacts of the rule using two measures that utilize the data EPA has on dental office baseline assets and estimated replacement capital costs: (1) Ratio of the Final Rule's Capital Costs to Total Dental Office Capital Assets and (2) Ratio of the Final Rule's Capital Costs to Annual Dental Office Capital Replacement Costs.

EPA did not conduct a traditional closure analysis for this final rule because EPA does not have detailed data on baseline financial conditions of dental offices. Also, closure analyses typically rely on accounting measures such as present value of after-tax cash flow, and such accounting measures are difficult to implement for businesses that are organized as sole proprietorships or partnerships, as typically is the case in the dental industry. EPA considered whether it should exclude these offices from the analyses, which is described further in EPA's proposal (79 FR 63272; October 22, 2014). Because EPA did not receive any comments to the contrary, EPA used the same assumptions for this final rule as it did at proposal with regard to low-revenue offices. EPA concluded that offices making less than $25,400 were baseline closures as traditionally accounted for in cost and economic impact analysis for effluent guidelines rulemakings. Using the Economic Census, EPA estimated that to be approximately 531 offices. Still, because of the uncertainty here, EPA analyzed the impacts twice: (1) Excluding dental offices that could represent baseline closures and (2) including all offices in the analysis. For each of the three analyses conducted below, EPA used the same methodology for the final rule's impact analysis as described in the proposal because EPA did not receive any comments to suggest a different approach for each impact analysis. Lastly, EPA used a 7 percent discount rate for the costs used in these three analyses described below. See the proposed rule for further description of the analyses below (79 FR 63272; October 22, 2014).

To provide an assessment of the impact of the rule on dental offices, EPA used a cost-to-revenue analysis as is standard practice when looking at impacts to small businesses under the Regulatory Flexibility Act (RFA) to determine if a rule has the potential to have a significant impact on a substantial number of small entities. The cost-to-revenue analysis compares the total annualized compliance cost of each regulatory option with the revenue of the entities.

EPA estimated the occurrence of annualized compliance costs exceeding the 1 percent and 3 percent of revenue thresholds for the final rule twice: (1) Excluding dental offices that could represent baseline closures (excluding baseline set-aside offices), and (2) including all offices in the analysis (including baseline set-aside offices).

Table IX-3 summarizes the results from this analysis. As shown there, under either scenario, over 99 percent of dental offices subject to this rule would incur annualized compliance costs of less than 1 percent of revenue. With baseline set-asides excluded from the analysis, 808 offices (0.7 percent of offices using dental amalgam and exceeding the set-aside revenue threshold) are estimated to incur costs exceeding 1 percent of revenue; no offices are estimated to incur costs exceeding 3 percent of revenue. With baseline set-asides included in the analysis, 1,217 offices (1 percent of offices using dental amalgam) are estimated to incur costs exceeding 1 percent of revenue; 174 offices (0.1 percent of offices using dental amalgam) are estimated to incur costs exceeding 3 percent of revenue.

This ratio examines the initial spending on capital costs of compliance in relation to the baseline value of assets on the balance sheet of dental office businesses. EPA assumes a low ratio implies limited impact on dental offices' ability to finance the initial spending on capital costs of the final rule. A high ratio may still allow costs to be financed but could imply a need to change capital planning and budgeting.

Table IX-4 reports the findings from this analysis, specifically the weighted average of the initial spending on the proposed rule's capital costs divided by total assets of dental office across the revenue range/number-of-chairs analysis combinations. With baseline set-asides excluded from the analysis, the resulting initial capital costs to total capital assets values are low, with an average value 0.4 percent to 0.7 percent for the no technology in-place case and zero percent for the technology in-place case. With baseline closures included in the analysis, the resulting initial capital costs to total capital assets values are low, with an average value 0.4 percent to 0.7 percent for the no technology in-place case and 0 percent for the technology in-place case.

EPA also compared the initial spending on capital costs of compliance associated with this rule to the estimated capital replacement costs for a dental office business (e.g., computer systems, chairs, x-ray machines, etc.) across all chair sizes. The capital replacement costs represent a value that dental offices may reasonably expect to spend in any year to replace and/or upgrade dental office capital equipment. EPA assumes a low ratio implies limited impact on dental offices' ability to finance the initial spending on capital costs of the final rule. A high ratio may still allow costs to be financed but could imply a need to change capital planning and budgeting. As expected, the results for this ratio are higher than the previous ratio in the test above, given that EPA expects replacement costs would be smaller than total capital assets. EPA performed this test because this ratio is based on a different data source, and so it provides an independent check that abstracts from the limitations of the data used in the test above. The resulting values for the final rule range from 2.0 percent to 2.8 percent, with a weighted average of 2.4 percent across all chair size ranges.

The analyses performed above inform the potential economic impact of this final rule on the dental office sector. In the cost-to-revenue analysis, EPA found that no more than 0.1 percent of offices, mostly in the lower revenue ranges, would potentially incur costs in excess of 3 percent of revenue. The two financial ratios reported in Tables IX-3 and IX-4 show that the final rule will not cause dental offices to encounter difficulty in financing initial spending on capital costs of the final rule. Based on the combined results of the three analyses and that EPA had no data since proposal to suggest otherwise, EPA determined that the final rule is economically achievable. Regarding large offices, EPA notes that, due to a lack of data, the economic impact analyses did not include large institutional offices. EPA did not receive comments indicating large offices would be impacted more or less than other dental offices subject to this rule. Given the results of the economic analysis performed on a range of office sizes indicating that the rule is economically achievable, EPA finds the rule would similarly be achievable for large institutional offices.

EPA determined that the final pretreatment standard for new sources will not be a barrier to entry. EPA relied on data describing the equipment needs and costs for starting a dental practice as compiled in Safety Net Dental Clinic Manual, prepared by the National Maternal & Child Oral Health Resource Center at Georgetown University (see DCN DA00143). Information from the Georgetown Manual demonstrates that the amalgam separator capital costs (based on costs for existing model offices as described in Section VII) comprised 0.2 percent to 0.3 percent of the cost of starting a dental practice as shown in Table IX-6 and, therefore, does not pose a barrier to entry.

EPA often uses cost-effectiveness analysis in the development and revision of ELGs to evaluate the relative efficiency of alternative regulatory options in removing toxic pollutants from effluent discharges to our nation's waters. Although not required by the CWA, and not a determining factor for establishing PSES or PSNS, cost-effectiveness analysis can be a useful tool for describing regulatory options that address toxic pollutants.

EPA defines the cost-effectiveness of a regulatory option as the incremental annual cost (in 1981 constant dollars to facilitate comparison to ELGs for other industrial categories promulgated over different years) per incremental toxic-weighted pollutant removals for that option. For more information about the methodology, data, and results, see Chapter 12 of the TEDD. EPA determines toxic-weighted pollutant removals for a particular pollutant by multiplying the number of pounds of a pollutant removed by an option by a toxic weighting factor (TWF). The toxic weighting factor for each pollutant measures its toxicity relative to copper,24 with more toxic pollutants having higher toxic weights. The use of toxic weights allows EPA to express the removals of different pollutants on a constant toxicity basis as toxic-pound- equivalents (lb-eq). In the case of indirect dischargers, the removal also accounts for the effectiveness of treatment at POTWs and reflects the toxic-weighted pounds after POTW treatment. The TWFs for the pollutants of concern are shown in Table X-1.

The costs used in the cost-effectiveness analyses are the estimated annual pre-tax costs described in Section IX, restated in 1981 dollars as a convention to allow comparisons with the reported cost effectiveness of other effluent guidelines. Collectively, the final PSES requirements have a cost-effectiveness ratio of $190-$195/lb-equivalent as shown in Table X-2 below. This cost-effectiveness ratio falls within the range of cost-effectiveness ratios for PSES requirements in other industries. A review of approximately 25 of the most recently promulgated or revised categorical pretreatment standards shows PSES cost-effectiveness ranges from less than $1/lb-equivalent (Inorganic Chemicals) to $380/lb-equivalent (Transportation Equipment Cleaning) in 1981 dollars.

EPA conducted a literature review concerning potential environmental impacts associated with mercury in dental amalgam discharged to surface water by POTWs (DCN DA00148). As discussed above, studies indicate that dental offices are the largest source of mercury entering POTWs. The total annual baseline discharge of dental mercury to POTWs is approximately 10,239 pounds (5.1 tons): 10,198 pounds are in the form of solid particles (99.6 percent) and 41 pounds (0.4 percent) are dissolved in the wastewater (DCN DA00018). Through POTW treatment, approximately 90 percent of dental mercury is removed from the wastewater and transferred to sewage sludge. The 10 percent of dental mercury not removed by POTW treatment is discharged to surface water. EPA estimates that POTWs annually discharge approximately 1,003 pounds of dental mercury nationwide.

The CWA regulations known as Standards for Use and Disposal of Sewage Sludge, 40 CFR part 503, control the land application, surface disposal, and incineration of sewage sludge generated by POTWs. Of the 11.2 billion dry pounds of sewage sludge generated annually, about 60 percent, or 6.7 billion pounds, are treated to produce biosolids for beneficial use as a soil amendment and applied to about 0.1 percent of agricultural lands in the United States (DCN DA00257). Approximately 5,500 pounds per year of dental mercury are contained in land- applied biosolids.

Approximately 18 percent, or 2 billion pounds, of the sewage sludge generated annually by POTWs are surface disposed in sewage sludge mono-fills or municipal landfills. Approximately 1,700 pounds per year of dental mercury are contained in surface disposed sewage sludge. Pollutant limits and monitoring requirements for surface disposed sewage sludge mono-fills are set by 40 CFR part 503 and by 40 CFR part 258 for municipal landfills. There may be additional state or local regulations that are more stringent than the federal biosolids regulations.

The remaining 22 percent, or 2.5 billion pounds, of sewage sludge generated annually by POTWs is disposed of through incineration. Approximately 2,000 pounds per year of dental mercury are contained in incinerated sewage sludge. 40 CFR part 503, subpart E sets requirements for the incineration of mercury and other toxic metals in sludge. For mercury, subpart E provides that incineration of sludge must meet the requirements of the National Emissions Standards for Mercury in subpart E of 40 CFR part 61.

Environmental assessment of impacts associated with POTW discharges of dental mercury is complicated by uncertainties about the fate and transport of mercury in aquatic environments. The elemental form of mercury used in dentistry has low water solubility and is not readily absorbed when ingested by humans, fish, or wildlife. However, elemental mercury may be converted into highly toxic methylmercury in aquatic environments by certain forms of anaerobic sulfate-reducing bacteria. Methylmercury has high potential to become increasingly concentrated up through aquatic food chains as larger fish eat smaller fish. Fish commonly eaten by humans may have methylmercury levels 100,000 times that of ambient water. The neurological effects of consumption of methylmercury-contaminated fish are well documented. Developmental effects to fetuses, infants, children, and fish consumption by women of childbearing age are of special concern. Neurological effects from predation of methylmercury-contaminated fish have been documented to occur in wild populations of fish, birds, and mammals in many areas of the United States (DCN DA00202). A plausible link has been identified between anthropogenic sources of mercury in the United States and methylmercury in fish. However, fish methylmercury concentrations also result from existing background concentrations of mercury which may consist of mercury from natural sources and atmospheric deposition of mercury in the United States from sources in other countries. Given the current scientific understanding of the environmental fate and transport of mercury, it is not possible to quantify how much of the methylmercury in fish consumed by the U.S. population is contributed by U.S. emissions relative to international mercury sources or natural mercury sources.

EPA was unable to assess the specific environmental impacts of dental mercury discharged by POTWs due to insufficient data needed to evaluate several fundamental factors about the discharge, fate, and transport of dental mercury in aquatic environments, including: the degree and geographic extent of dental mercury methylation in aquatic environments, the amount of methylated dental mercury that is taken up by fish and wildlife, the human consumption rates of fish contaminated with methylated dental mercury, and the extent and magnitude of naturally- occurring mercury in aquatic environments.

While EPA did not perform a quantitative environmental benefits analysis of the final rule, due to insufficient data about the aquatic fate and transport of dental mercury discharged by POTWs, EPA was able to assess the qualitative environmental benefits based on existing information. For example, EPA identified studies that show that decreased point-source discharges of mercury to surface water result in lower methylmercury concentrations in fish. Moreover, several studies quantify economic benefits from improved human health and ecological conditions resulting from lower fish concentrations of methylmercury (DCN DA00148). The final pretreatment standards will produce human health and ecological benefits by reducing the estimated annual nationwide POTW discharge of dental mercury to surface water from 1,003 pounds to 11 pounds.

Eliminating or reducing one form of pollution may cause other environmental problems. Sections 304(b) and 306 of the Clean Water Act require EPA to consider non-water quality environmental impacts (including energy requirements) associated with effluent limitations guidelines and standards. To comply with these requirements, EPA considered the potential impact of the technology basis on energy consumption, air pollution, and solid waste generation. As shown below, EPA anticipates that the rule would produce minimal non-water quality environmental impacts and as such determined they are acceptable. Additional information about the analysis of these non-water quality impacts is contained in the TEDD.

Net energy consumption considers the incremental electrical requirements associated with operating and maintaining dental amalgam separators used in combination with BMPs that form the technology basis for the standards. As described in Section V, most amalgam separators use sedimentation, either alone or in conjunction with filtration to remove solids in the waste stream. Most separators rely on gravity or the suction of the existing vacuum system to operate, and do not require an additional electrical power source. As noted in Section V, some separators have warning indicators that require a battery or power source. EPA does not anticipate this would pose any considerable energy requirements. Moreover, the addition of an amalgam separator is likely to reduce energy consumption at dental offices that do not currently employ an amalgam separator as it will prevent small particles from impeding the vacuum pump impeller. A clean impeller is more efficient than a dirty impeller, and thus will draw less energy (DCN DA00465). Upon consideration of all of these factors, EPA concludes there will be no significant energy requirements associated with this final rule.

Unbound mercury is highly volatile and can easily evaporate into the atmosphere. An estimated 99.6 percent of dental mercury discharges are in solid bound form; i.e. elemental mercury bound to amalgam particles (DCN DA00018). Because the majority of dental mercury is bound to solid particles, it likely will not volatize to the atmosphere. Therefore, EPA expects the final PSES and PSNS will not pose any increases in air pollution.

In the absence of amalgam separators, a portion of the amalgam rinsed into chair-side drains is collected by chair-side traps. The remainder is discharged to the POTW where the vast majority is removed from the wastewater and becomes part of the POTW sludge that may be land-applied, disposed of in landfills or mono-fills, or incinerated. EPA expect the final rule to increase the use of amalgam separators nationwide by one and a half times with a corresponding increase in collection and recycling of used amalgam from the spent separator canisters. EPA expects the operation and maintenance requirements associated with the amalgam separator compliance option included in the final rule will further promote recycling as the primary means of amalgam waste management, because many amalgam separator manufactures and dental office suppliers have begun offering waste handling services that send dental amalgam waste to retorting and recycling facilities. Nationally, EPA expects less dental amalgam will be discharged to POTWs leading to reductions in the amount of mercury discharged to surface waters and land-applied, landfilled, or released to the air during incineration of sludge. Instead, EPA expects that the waste will be collected in separator canisters and recycled. After the amalgam containing waste has been recycled, the canisters are either recycled or landfilled. For purposes of assessing the incremental solid waste generation, EPA conservatively assumes all of the canisters are landfilled. EPA finds that if each dental office generated an average of 2 pounds of spent canisters per year, the total mass of solid waste generated would still comprise less than 0.0001 percent of the 254 million tons of solid waste generated by Americans annually (DCN DA00496). Based on this evaluation of incremental solid waste generation, EPA concludes there will not be a significant incremental non-water quality impact associated with solid waste generation as a result of this final rule.

This rule references standards from the American National Standards Institute/American Dental Association and the International Organization for Standardization, and in compliance with the National Technology Transfer and Advancement Act (see Section XIV). They are available either at EPA's Water Docket (see ADDRESSES section above) for inspection, or on their respective Web sites to everyone at a cost determined by the respective Web site, generally from $100 to $150. The cost of obtaining these standards is not a significant financial burden for a discharger or environmental laboratory, making the standards reasonably available. The individual standards are discussed in greater detail below.

The installation, operation, and maintenance of one or more amalgam separators compliant with either the ADA 2009 standard with the 2011 addendum, or the ISO standard when removing dental amalgam solids from all amalgam process wastewater:

• ANSI/ADA Specification No. 108:2009, American National Standard/American Dental Association Specification No. 108 Amalgam Separators.

• ANSI/ADA Specification No. 108:2009 Addendum, American National Standard/American Dental Association Specification No. 108 Amalgam Separators, Addendum.

• International Standard ISO 11143;2008, Dentistry—Amalgam Separators.

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

This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review because it raises novel legal or policy issues. Any changes made in response to OMB recommendations have been documented in the docket. The economic analysis is available in the docket (DCN DA00458) and is briefly summarized in Section IX. The benefits are summarized in Section XI.

The information collection requirements in this final rule have been submitted for approval to the OMB under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. The Information Collection Request (ICR) document prepared by EPA has been assigned EPA ICR number 2514.02. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.

EPA estimates it would take a total annual average of 402,000 hours and $7.2 million for affected dental offices to collect and report the information required in the final rule. This estimate includes effort for each dental office associated with completing a one-time compliance report. EPA based this estimate on average labor rates from the Bureau of Labor Statistics for the dental office personnel involved in collecting and reporting the information required. EPA estimates it would take a total annual average of 34,000 hours and $2.02 million for Control Authorities to review the information submitted by dental offices. EPA estimates that there would be no start-up or capital costs associated with the information described above. Burden is defined at 5 CFR 1320(b).

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce the approval in the Federal Register and publish a technical amendment to 40 CFR part 9 to display the OMB control number for the approved information collection activities in this final rule.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are defined as: (1) A small business in the Dental Office sector (NAICS 621210) with annual receipts of 7.5 million dollars or less (based on SBA size standards); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for- profit enterprise which is independently owned and operated and is not dominant in its field.

The Agency has determined that 116,014 dental offices out of 116,720 dental offices potentially subject to this final rule meet the small business definition. EPA's analysis of projected impacts on small dental offices is described in detail in Section IX. EPA projects less than 1 percent of 116,720 affected dental offices would incur compliance costs exceeding 1 percent of revenue and no more than 0.2 percent would incur compliance costs exceeding 3 percent of revenue.

Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this final rule on small entities. First, this final rule will allow dental offices with existing separators to satisfy the requirements for a period of up to 10 years. Second, EPA significantly reduced the rule's reporting requirements for all affected dental offices as compared to the reporting requirements for other industries with categorical pretreatment standards.

This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The annual cost of the final rule is $59 to $61 million; thus, this final rule is not subject to the requirements of sections 202 or 205 of UMRA.

This final rule is also not subject to the requirements of section 203 of UMRA, because it contains no regulatory requirements that may significantly or uniquely affect small governments. EPA has not identified any dental offices that are owned by small governments. While this final rule impacts government entities required to administer pretreatment standards, small governments will generally not be affected. By statute, a small government jurisdiction is defined as a government of a city, county, town, school district or special district with a population of less than 50,000 (5 U.S.C 601). Control authorities are responsible for oversight and administration associated with this final rule. A POTW is required to become a Control Authority when it (or a combination of POTWs operated by the same authority) has a design flow of at least 5 million gallons per day and receives pollutants from industrial users that would pass through or interfere with the operations and cause a violation of the POTW's NPDES permit. The average water use per person is 100 gallons per day so a POTW with a population less than 50,000 would likely have a flow less than 5 MGD. Therefore, EPA does not expect small government owned POTWs to be required to become a Control Authority. EPA is aware that some small POTWs have approved pretreatment programs so they serve as a Control Authority. To the extent small POTWs with pre-existing approved pretreatment programs receive dental discharges subject to this rule, they would incur some incremental oversight requirements as described in Section VI. However, EPA expects such cases to be limited.

This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This final rule does not have tribal implications, as specified in Executive Order 13175. It does not have substantial direct effects on Tribal governments, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes. This final rule contains no Federal mandates for Tribal governments and does not impose any enforceable duties on Tribal governments. Thus, Executive Order 13175 does not apply to this final rule.

This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not project the environmental health or safety risks addressed by this action present a disproportionate risk to children. This final rule will reduce the amount of mercury from dental amalgam entering POTW's and eventually the nation's waters, which will reduce impacts to the neurological development of children.

This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. EPA determined that any additional energy usage would be insignificant to the total energy usage of Dental Offices and total annual U.S. energy consumption.

This final rule involves technical standards. The Agency decided to use the American National Standards Institute (ANSI) American National Standard/American Dental Association (ADA) Specification 108 for Amalgam Separators (2009) with Technical Addendum (2011) or the International Organization for Standardization (ISO) 11143 Standard (2008) or the International Organization for Standardization (ISO) efficiency standards for amalgam separators (ISO 11143) developed in 1999 and updated in 2008. One approach to meet the standards in this rule is to install and operate an amalgam separator(s) compliant with one of these standards or their equivalent. These voluntary standard setting organizations established a standard for measuring amalgam separator efficiency by evaluating the retention of amalgam mercury using specified test procedures in a laboratory setting. They also include requirements for instructions for use and operation and maintenance.

EPA determined that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). While EPA was unable to perform a detailed environmental justice analysis because it lacks data on the location of POTWs to which dental discharges currently occur, this final rule will increase the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This final rule will reduce the amount of mercury from dental amalgam entering POTW's and eventually the nation's waters, to benefit all of society, including minority communities.

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

This is a summary of the Commission's Report and Order, ET Docket No. 15-99, FCC 17-33, adopted March 27, 2017, and released March 29, 2017. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The full text may also be downloaded at: https://apps.fcc.gov/edocs_public/attachmatch/FCC-17-33A1.pdf. People with Disabilities: 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 & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

1. On April 23, 2015, the Commission adopted a Notice of Proposed Rulemaking (WRC-12 NPRM) in this proceeding, 80 FR 38315, July 2, 2015. In this Report and Order (WRC-12 R&O), the Commission amended the Table of Frequency Allocations (Allocation Table) in § 2.106 of its rules and a number of related service rules to implement certain radio frequency (RF) allocation decisions from the Final Acts of the World Radiocommunication Conference (Geneva, 2012) (WRC-12 Final Acts). The following are the major actions that the Commission took to support non-Federal spectrum requirements:

• Allocated the 472-479 kHz band to the amateur service on a secondary basis and amended part 97 to provide for amateur service use of this band and of the 135.7-137.8 kHz band.

• Amended part 80 to authorize radio buoy operations in the 1900-2000 kHz band under a ship station license.

• Allocated eight frequency bands in the 4 to 44 MHz range to the radiolocation service for Federal and non-Federal use, limited to oceanographic radars. The Commission also amended part 90 to provide for licensing of oceanographic radars, and required those radars currently operating under an experimental license to conform their operations to the adopted rules within five years of the effective date of this Order.

• Reallocated the 156.7625-156.7875 MHz and 156.8125-156.8375 MHz bands to the mobile-satellite service (MSS) (Earth-to-space) on a primary basis for Federal and non-Federal use, limited to the reception of Automatic Identification Systems (AIS) broadcast messages from ships. The Commission also amended part 80 to permit ships to transmit AIS broadcast messages in these bands, and amended part 25 to permit MSS satellites to receive in these bands and in the existing AIS bands.

• Allocated the 5000-5091 MHz band to the aeronautical mobile (route) service (AM(R)S) on a primary basis for Federal and non-Federal use. AM(R)S use of the 5000-5030 MHz band extends the tuning range for the recently-established Aeronautical Mobile Airport Communications System (AeroMACS) that will support surface applications at airports. AM(R)S use of the 5030-5091 MHz band will support unmanned aircraft systems (UAS).

2. In the WRC-12 R&O, the Commission amended Parts 2, 15, 25, 80, 90, and 97 of its rules to implement specific allocations from the WRC-12 Final Acts that affect a number of frequency bands between 8.3 kHz and 3000 GHz and to adopt related service rules. These actions are described in greater detail below.

3. As proposed in the WRC-12 NPRM, the Commission allocated the 472-479 kHz band to the amateur service on a secondary basis and limited the maximum equivalent isotropically radiated power (EIRP) of amateur stations using this band to five watts in the United States, except for that portion of Alaska that is within 800 kilometers of the Russian Federation's borders, where the maximum EIRP is limited to one watt.

4. The amateur service will share this band with Power Line Carrier (PLC) systems, which electric utility companies use and operate in the 9-490 kHz range under part 15 of the Commission's rules on an unprotected and non-interference basis with respect to authorized radio users. While the Utilities Telecom Council (UTC) objected to the Commission's allocation proposal on the basis that an increased interference potential between amateur operations and PLC systems could deprive utilities of the flexibility needed to deploy PLC systems, the amateur radio community supported this allocation as useful for improving technical knowledge on radio propagation and because they believed that co-existence with PLC systems is possible due to existing amateur service operations on frequencies near 500 kHz under experimental licenses that have not resulted in any interference complaints.

5. The Commission agreed that adding a secondary amateur service allocation to the 472-479 kHz band will provide new opportunities for amateur operators to experiment with equipment, techniques, antennas, and propagation phenomena. The 472-479 kHz band offers amateur service operators different propagation characteristics from the 135.7-137.8 kHz band, which was allocated on a secondary basis to amateur service in the WRC-07 Report and Order. Further, a secondary allocation to the amateur service harmonizes the United States and international allocations for this band and provide new opportunities for amateur service experimentation. At the same time, the Commission recognized the importance of PLC systems and their impact on utility safety, security and reliability of utility operations, and found that co-existence between PLC systems and amateur radio operations in these bands is possible under the service rules the Commission adopted in this Order.

6. As proposed in the WRC-12 NPRM, the Commission removed several allocations from the 135.7-137.8 kHz and 472-479 kHz bands. It deleted the non-Federal fixed service (FS) and maritime mobile service (MMS) allocations from the 135.7-137.8 kHz band because there are no non-Federal stations in the FS and MMS that are licensed to operate in this band, and because it found that any future requirements for non-Federal stations in the FS or MMS can be accommodated in other frequency bands. However, because there is some limited Federal use of this band, the Commission maintained the existing primary FS and MMS allocations in the Federal Table. The Commission deleted the Federal MMS and aeronautical radionavigation service (ARNS) allocations and the non-Federal MMS allocation from the 472-479 kHz band. NTIA has not authorized any Federal stations in the ARNS or MMS to operate in the 472-479 kHz band, and there is only limited use of the non-Federal MMS allocation. Any future requirements for non-Federal MMS stations can be accommodated in other frequency bands. However, there are two non-Federal licensees that operate three public coast stations under their current licenses on a primary basis. The Commission grandfathered operation of these stations by amending § 80.357(b)(1) to limit the use of the 472-479 kHz band to public coast stations that were licensed as of the effective date of this Report and Order and by adding a footnote to the Table of Allocations that grandfathers the following licensees to operate public coast stations on a primary basis in the 472-479 kHz band pursuant to their current radio station authorization, subject to periodic renewals: Global HF Net LLC (call signs KFS and WNU) and New England Historical Radio Society, Inc. (call sign WNE).

7. The Commission adopted service rules for the amateur radio service in the 135.7-137.8 kHz (2200 meter band) and 472-479 kHz (630 meter band) bands that will ensure the compatibility of amateur radio operations and PLC systems that operate in these bands, and promote the shared use of these bands. Under these rules, electric utilities will not be required to modify existing PLC systems to accommodate amateur operations, and previously notified amateur stations will not be required to alter their operations to accommodate new or modified PLC operations.

8. As proposed, the Commission will permit amateur stations to operate in the 135.7-137.8 kHz and 472-479 kHz bands when separated by a specified distance from electric power transmission lines with PLC systems that use the same bands. To support the operations of both the amateur service and PLC systems in these bands, the Commission adopted a minimum horizontal separation distance of one kilometer between the transmission line and the amateur station when operating in these bands.

9. Regarding operations in the 135.7-137.8 kHz band, ARRL provided a technical analysis in ET Docket No. 12-338, which concluded that PLC systems “will be sufficiently protected from amateur stations transmitting at an EIRP of 1 W with a separation distance of 1 km from the transmission lines carrying the PLC signals, beyond which there is no interference potential.” UTC agreed with this conclusion and supported a separation distance of at least one kilometer for amateur operation in this band. While ARRL preferred that amateur stations have the option to be located closer to the transmission lines with PLC systems and recommended a notification procedure to address any potential interference to PLC systems, the Commission found that a one kilometer separation distance reasonably ensures that PLC systems and amateur radio stations are unlikely to experience interference. In addition, establishing a zone where amateur use is not authorized will simplify and streamline the process for determining whether an amateur station can transmit in these bands when in proximity to transmission lines upon which PLC systems operate.

10. The Commission adopted the same separation distance for amateur operations in the 472-479 kHz band, as it did for the 135.7-137.8 kHz band, since these bands share the same considerations for co-existence of the two uses.

11. The Commission restricted amateur service operations to fixed locations and prohibited mobile operations in these bands. This restriction will ensure that amateur stations remain at the locations specified in their notification and comply with the separation distance requirements discussed below. UTC and some amateur service commenters supported this restriction. The Commission will allow temporary fixed use at sites that meet its technical rules and follow its notification requirements. In other words, the location of the amateur station must not be located within one kilometer of PLC systems and its operations must be in accordance with part 97 rules.

12. The Commission required amateur operators to notify UTC of the location of their proposed station prior to commencing operations, to confirm that the station is not located within the one kilometer separation distance. Even though several amateur service commenters claimed that they can readily identify transmission lines and compute the separation distance, the Commission found that transmission lines are not always readily identifiable. Further, amateur operators may not be able to determine whether PLC systems operate in the relevant bands on the subject transmission lines. The notification requirement will entail notifying UTC of the operator's call sign and coordinates of the proposed station's location for confirmation that the location is outside the one kilometer separation distance, or the relevant PLC system is not transmitting on the requested bands. UTC, which maintains a database of PLC systems must respond to the notification within 30 days if it objects. If UTC raises no objection, amateur radio operators may commence operations on the band identified in their notification. The Wireless Telecommunications Bureau will issue a public notice providing the details for filing notifications with UTC.

13. The notification procedures the Commission adopted seek to strike a balance between amateur operations used for experimental purposes and PLC operation used by electric utilities for the reliability and security of electric service to the public. These procedures are the least burdensome considering the Commission seeks to ensure that no potential interference occurs from these two uses. A simple notification to UTC with a 30-day waiting period does not appear to be burdensome. Amateur operations can commence as soon as that period expires. While ARRL sought direct access to the PLC database, the Commission noted that UTC has control of the PLC database which can be updated, and found no reason to mandate its release to another party especially considering the sensitive nature of information it contains.

14. If an electric utility seeks to deploy a new or modified PLC system on a transmission line that is within one kilometer of a previously coordinated amateur station, the electric utility must employ a frequency in the 9-490 kHz range that has not been included in the amateur station's notification, as ARRL suggests. If the previously coordinated amateur station no longer operates in the band, the electric utility may deploy a PLC system in that band.

15. As discussed in the WRC-12 NPRM, the Commission adopted maximum EIRP limits and transmitter power limits for the new amateur service bands. Amateur stations may operate in the 135.7-137.8 kHz band with a maximum radiated power of one watt EIRP. The Commission found that amateur stations operating in the 135.7-137.8 kHz band should be subject only to the general part 97 limit of 1.5 kW peak envelope power (PEP). The Commission found it unnecessary to limit the transmitter power beyond what it is already provided for in its rules, because antennas used in this frequency band are highly inefficient in converting the RF power delivered to the antenna terminals.

16. The Commission also adopted the power limits proposed in the WRC-12 NPRM for amateur stations operating in the 472-479 kHz band. For such stations, the maximum radiated power will be five watts EIRP, except for stations located in the portion of Alaska that is within 800 kilometers of the Russian Federation, where the EIRP will be limited to one watt. The Commission also limited the transmitter power for amateur radio operations in the 472-479 kHz band to 500 watts PEP; provided, however, that the resulting radiated power does not exceed five watts EIRP. In other words, it may be necessary to reduce transmitter power below 500 watts PEP to avoid exceeding the five watts EIRP limit.

17. As discussed in the WRC-12 NPRM, the Commission required that the antennas used to transmit in these bands not exceed 60 meters in height above ground level, as ARRL proposed. The adoption of this height restriction will aid in the sharing of these amateur service bands with PLC systems by limiting the potential for amateurs' signals to exceed the adopted EIRP limits with longer, higher gain antennas, and could reduce the number of antenna structures that must comply with the Federal Aviation Administration notification and obstruction marking and lighting requirements in part 17 of the Commission's rules.

18. As discussed in the WRC-12 NPRM, the Commission made these bands available for Amateur Extra, Advanced and General Class licensees. Consistent with its proposal in the WRC-12 NPRM and with the existing rules in § 97.305 for the frequency bands below 30 MHz, the Commission authorized amateur stations to transmit the following emission types throughout the new amateur bands: CW (international Morse code telegraphy), RTTY (narrow-band direct-printing telegraphy), data, phone, and image emissions. These emission types provide amateur operators with maximum flexibility, and the Commission found that additional restrictions would needlessly hinder experimentation.

19. The Commission amended § 97.303 to list the radiocommunication services that must be protected from harmful interference. Specifically, amateur stations transmitting in the 135.7-137.8 kHz band must not cause harmful interference to, and must accept interference from, stations authorized by the United States Government in the fixed and maritime mobile services and stations authorized by other nations in the fixed, maritime mobile, and radionavigation services. Amateur stations transmitting in the 472-479 kHz band must not cause harmful interference to, and must accept interference from, stations authorized by the Commission in the maritime mobile service and stations authorized by other nations in the maritime mobile and aeronautical radionavigation services.

20. The Commission declined to prohibit automatically controlled stations from operating in these bands. Further, as proposed in the WRC-12 NPRM, the Commission added definitions for the terms effective radiated power, isotropically radiated power and LF (low frequency) in section 97.3 of its rules. Finally, the Commission declined to permit previously licensed experimental stations—some of which have been authorized with significantly more radiated power than the adopted EIRP limits for these new amateur service bands—to communicate with amateur stations operating in these bands. Amateur operations in these bands currently authorized under experimental licenses should transition their operations in accordance with the adopted rules and not circumvent such rules by use of experimental licenses.

21. The Commission allocated the 1900-2000 kHz band to the MMS on a primary basis for non-Federal use in ITU Regions 2 and 3, and limited the use of this allocation to radio buoys on the open sea and the Great Lakes. Section 80.5 of the Commission's rules define open sea as the water area of the open coast seaward of the ordinary low-water mark, or seaward of inland waters. This allocation addresses the limited situations where radio buoys cannot be authorized under the radiolocation service allocation because of newer technology that uses features like GPS rather than radiodetermination.

22. In the WRC-07 R&O, the Commission recognized the public benefit associated with the use of radio buoys by the U.S. commercial fishing fleet, and in the WRC-12 NPRM the Commission proposed revisions to its rules that would provide radio buoy operators with a legitimate path to operate. In doing so, the Commission proposed to geographically limit the use of the MMS allocation, and the existing radiolocation service allocation, to radio buoys used by the U.S. commercial fishing fleet on the open sea, but sought comment on whether the geographic area should be extended to include the Chesapeake Bay, Great Lakes, or other inland waters.

23. The Commission recognized ARRL's concerns that radio buoy manufacturers will not be able to ensure where fishing vessels will be using radio buoys. However, the Commission believes that amateur radio and radio buoys can continue to share this frequency band as they have done for many years. Because radio buoys are low-power and narrow-bandwidth devices, while amateur stations tend to use much higher power, the Commission believes that they can continue to be accommodated with minimal impact on amateur radio operations. Any intermittent interference amateur operators may receive in the 1900-2000 kHz band from lower-powered radio buoys is not expected to significantly hamper amateur operations in the band because amateur operators can readily tune around these narrow radio buoy signals and because the adjacent 1800-1900 kHz band is allocated exclusively for amateur radio use. Although the Commission had requested comment on rules that would have effectively permitted radio buoys to operate on any waters where the United States exercises sovereignty, the Commission was persuaded by ARRL's comments to adopt final rules that are better tailored to the places where the commercial fishing fleet can make reasonable and productive use of radio buoys. The Commission thus found it in the public interest to permit commercial fishing vessels to use these buoys on the open sea and the Great Lakes.

24. Also, the Commission amended, as proposed, footnote NG92 to provide that the co-primary services in the 1900-2000 kHz band are protected from harmful interference only to the extent that the offending station is not operating in accordance with the technical rules. This statement clarifies that co-primary allocations in the 1900-2000 kHz band (i.e., the amateur, radiolocation, and maritime mobile services) share the same type of interference protection—one that protects only from a violation of the technical rules. Radio buoys and amateur stations have co-equal status and therefore have the same level of interference protection from each other.

25. The Commission declined to make additional spectrum available for radio buoy use. In the WRC-12 NPRM the Commission sought comment on alternative approaches that would allow continued radio buoy use by the U.S. commercial fishing fleet, including allocating additional spectrum. Several amateur radio commenters requested that new radio buoys be transitioned to another nearby frequency band. However, the Commission did not agree that additional spectrum is necessary for radio buoy operations because the 1900-2000 kHz band can be successfully shared with amateurs and the number of radio buoys does not appear to be significant enough to require a different allocation. In addition, as stated above, the 1800-1900 kHz band is already allocated for exclusive amateur use, and the record does not indicate that this exclusive allocation is insufficient and that the public interest would be served by creating an additional exclusive allocation for amateur use at 1900-2000 kHz. Therefore, it appeared unnecessary for the Commission to make additional spectrum available for exclusive amateur use at this time by relocating low-power radio buoys out of the 1900-2000 kHz band.

26. The Commission amended part 80 of its rules to authorize the use of frequencies in the 1900-2000 kHz band for radio buoy operations under a ship station license provided that the use of these frequencies is related to commercial fishing operations, the transmitter output power does not exceed 8 watts, and the station antenna height does not exceed 4.6 meters above sea level in a buoy station or 6 meters above the mast of the ship on which it is installed.

27. In the WRC-12 NPRM, the Commission proposed to authorize buoy stations in the 1900-2000 kHz band, provided that the output power does not exceed 10 watts and the station antenna height does not exceed 4.6 meters above sea level in a buoy station or 6 meters above the mast of the ship on which it is installed. While part 90 did not establish power limits in this band, no equipment authorization has been sought with an output power over 8 watts. To address some of the amateur community's concerns over potential interference from these radio buoys, the Commission limited radio buoys transmitter output power to 8 watts.

28. The Commission found it unnecessary to provide the proposed six-month phase-out period for part 90 equipment authorizations considering that no applications for radio buoy equipment operating in the 1900-2000 kHz band have been submitted since the adoption of the WRC-12 NPRM. Hence, applications for equipment authorization of radio buoys must meet the new part 80 rules, as of the effective date of this Order. Also as proposed, the Commission grandfathered radio buoys authorized under § 90.103(b) prior to the cutoff date so they may continue to be manufactured, imported, and marketed under the previously approved equipment authorization.

29. The Commission took actions in support of aeronautical mobile (route) service (AM(R)S) surface applications at airports in the 5000-5030 MHz band and unmanned aircraft systems (UAS) in the 5030-5091 MHz band. As proposed, the Commission allocated the 5000-5030 MHz bands to the AM(R)S on a primary basis for Federal and non-Federal use, for systems operating in accordance with international aeronautical standards, limited to surface applications at airports (i.e., AeroMACS). AeroMACS refers to a collection of high data rate wireless networks that are used for airport surface operations (i.e. ground-to-ground communications) to provide broadband communications between aircraft and other ground vehicles, as well as between critical fixed assets. AeroMACS is designed to support a wide variety of services and applications, including Air Traffic Control/Air Traffic Management and infrastructure functions, as well as airline and airport operations.

30. In the WRC-07 R&O, the Commission made the globally harmonized 5091-5150 MHz band available for AeroMACS, expecting that it will be the main frequency band for deployment of AeroMACS. The Commission found that there is a need for additional spectrum, especially at the nation's busiest airports. This action extended the tuning range for AeroMACS to include the 5000-5030 MHz band in the United States.

31. The Commission allocated the 5030-5091 MHz band to the AM(R)S on a primary basis for Federal and non-Federal use and added international footnote 5.443C to this band limiting the use to internationally standardized aeronautical systems and setting limits for unwanted emissions from AM(R)S stations to adjacent band radionavigation-satellite service (RNSS) downlinks to an EIRP density of -75 dBW/MHz. The WRC-12 NPRM proposal, which was based on the U.S. Proposals for WRC-12, noted that the 5030-5091 MHz band would be appropriate to satisfy the terrestrial, line-of-sight, spectrum requirements for command and control of UAS in non-segregated airspace. The Commission adopted the AM(R)S allocation to support the anticipated growth of UAS and promote their safe operation. Technical and operational rules relating to altitude, weight, or other requirements will be addressed in the service rules for this band, which will be promulgated in a separate proceeding.

32. As proposed, the Commission added an entry in the U.S. Table that reflects the primary aeronautical mobile-satellite (R) service (AMS(R)S) allocation in the 5000-5150 MHz band, previously reflected in a footnote. Further, the Commission adopted two international footnotes that limit the AMS(R)S allocation to internationally standardized aeronautical systems.

33. The Commission did not adopt proposed footnote US162, which would have encouraged fixed service operators transmitting in the adjacent bands (81-86 GHz and 92-94 GHz) to take all reasonable steps to ensure that their unwanted emissions power in the 86-92 GHz passive band does not exceed WRC-12's non-mandatory unwanted emissions levels.

34. The 86-92 GHz band is allocated to the Earth exploration-satellite service (EESS) (passive), radio astronomy service, and space research service (passive). WRC-12 sought to protect the EESS passive sensors that receive in this band, proposed non-mandatory protection requirements from out-of-band emissions from active services in adjacent bands and “urge[d] administrations to take all reasonable steps to ensure” that such emissions do not exceed the recommended maximum levels. The WRC-12 NPRM proposed the adoption of a footnote that would “encourage operators of fixed stations [. . .] to take all reasonable steps to ensure that their unwanted emissions in the 86-92 GHz does not exceed WRC-12's non-mandatory unwanted emission levels” (emphasis added).

35. The Commission recognized that the proposed footnote US162 provides emission limits that are significantly more stringent than those in part 101 and concluded that adoption of the footnote would be confusing for incumbent users of the adjacent bands and would not provide any meaningful protection for the EESS passive sensors in the 86-92 GHz band beyond that already required under part 101 of the rules. Further, the adoption of the underlying emission limits for the protection of the EESS passive sensors in the 86-92 GHz band, an action supported by CORF, would require a proceeding in order to develop a record that could support changes to the existing rules. The current proceeding does not provide the appropriate proper framework to address such changes. In addition, there are other proceedings underway addressing part 101 emission mask rules governing fixed operations in these bands that may be better suited in examining these considerations.

36. As proposed, the Commission extended the U.S. Table of Allocations past the 275-1000 GHz band to 3000 GHz. These bands are “not allocated” to specific services, though passive services such as the EESS, space research service (SRS), and radio astronomy service already utilize portions of the 275-3000 GHz range for scientific observation. The Commission adopted a revised footnote US565 which incorporates language of the new international footnote 5.565 and of the proposed footnote US565.

37. WRC-12 revised international footnote 5.565 to identify an additional 226 gigahertz of spectrum for passive spaceborne sensor use in the 275-990 GHz range. The footnote further urges administrations, when making those frequencies available for active service applications to take all practicable steps to protect these passive services from harmful interference, until the date when the Table of Frequency Allocations is established in the 275-1000 GHz frequency range. CORF, in its comments, generally supported the sharing of frequency allocations where practical, stating that technical factors associated with radio transmission in these high frequencies may well support shared use in many cases. However, CORF objected to the proposed U.S. footnote because it appears to be at odds with international footnote 5.565's “explicit goal of protecting passive uses.”

38. The Commission did not agree with CORF's interpretation and was concerned that the text of international footnote 5.565 could be construed as placing a reservation for future passive service allocations in the U.S. Table, which would inhibit development of other radiocommunication services in this spectrum. Consistent with its tentatively conclusion in the WRC-12 NPRM, the Commission found that it is premature to establish a specific allocation in the U.S. Table in this frequency range and that it is unnecessary to place spectrum use restrictions in these frequencies. Instead, maintaining spectrum flexibility in these bands will encourage the development of new uses in the future.

39. The Commission recognized that the 275-3000 GHz frequency range is used—and may be used more extensively in the future—for experimentation with, and development of, an array of active service applications. Because international footnote 5.565 can be interpreted as establishing an “allocation” for passive uses only, the Commission found that the text of this international footnote must be clarified. In particular, the Commission was not prepared to determine whether the frequency bands identified for use by passive service applications in international footnote 5.565 are entitled to interference protection from a yet-to-be proposed active service. For these reasons, the Commission revised existing footnote US565 to identify expected passive uses of the 275-1000 GHz range and to clarify that this footnote does not establish any priority of use in the U.S. Table, and does not preclude or constrain any active service use or future allocation of frequency bands in the 275-3000 GHz range. This clarifying text is sufficient, given that passive and active services can share frequencies above 275 GHz without constraints, especially considering the atmospheric absorption at these frequencies and the narrowness of the antenna beamwidths, which make sharing among different services possible.

40. The Commission amended §§ 2.100, 2.102, 2.106, 80.215, 80.373, 80.871, 90.7, 90.103, and 90.425 of its rules to implement proposals in the WRC-12 NPRM that were not addressed by any of the commenters. It found these proposals implement important U.S. policy goals and serve the public interest for the reasons stated in the WRC-12 NPRM.

41. Passive Systems for Lightning Detection (8.3-11.3 kHz). The Commission allocated the 8.3-9 kHz and 9-11.3 kHz bands to the meteorological aids service on a primary basis for Federal and non-Federal use. The Commission also adopted international footnote 5.54A, limiting use of these frequency bands to passive use only. Consequently, the Commission revised Section 2.102(a) to require that the assignment of frequencies between 8.3 kHz and 275 GHz be in accordance with the Allocation Table.

42. Maritime Mobile Service Use of the Frequency 500 kHz. The Commission allocated the 495-505 kHz band to the maritime mobile service, removes the aeronautical mobile and land mobile service portions of the existing allocation, and removes the existing distress and calling restriction.

43. Oceanographic Radar Applications in the 4-44 MHz Range. The Commission allocated seven frequency bands (4.438-4.488 MHz, 5.25-5.275 MHz, 16.1-16.2 MHz, 24.45-24.65 MHz, 26.2-26.42 MHz, 41.015-41.665 MHz, and 43.35-44 MHz) to the radiolocation service (RLS) on a primary basis for Federal and non-Federal use, and allocate the 13.45-13.55 MHz band to the RLS on a secondary basis for Federal and non-Federal use. The Commission added footnotes to the U.S. Table that prohibit oceanographic radars transmitting in these bands from causing harmful interference to, or claiming protection from, existing and future stations in the incumbent fixed and mobile services. The Commission also raised to primary status the secondary mobile except aeronautical mobile service allocation in the 5.25-5.275 MHz band, so that existing and future stations in this service can also be protected from interference from oceanographic radars. Next, the Commission amended part 90 of its rules by adding the oceanographic radar bands to the Radiolocation Service Frequency Table and took other associated actions that incorporate WRC-12's operational requirements for oceanographic radars and allowed licensees of existing experimental stations to apply for part 90 licenses. Finally, the Commission required that all oceanographic radar licensees currently operating under part 5 of the rules transition their operations to frequencies within an allocated band within five years of the effective date of this Report and Order.

44. Improved Satellite-AIS Capability. To improve satellite detection of messages from maritime Automatic Identification Systems (AIS), the Commission reallocated two bands—156.7625-156.7875 MHz (AIS 3) and 156.8125-156.8375 MHz (AIS 4)—to the mobile-satellite service (MSS), restricted to Earth-to-space (uplink) operations, on a primary basis for Federal and non-Federal use. The Commission revised footnote US52 to restrict the use of these MSS uplink allocations to the reception of long-range AIS broadcast messages from ships. The Commission removed the primary MMS allocation from these bands and amends the relevant rules to remove references to these MMS frequencies. The Commission further revised footnote US52 to grandfather the single MMS licensee (BKEP Materials, LLC) until the expiration date of its licenses (August 26, 2019). The Commission amended Section 80.203 to clarify that it will no longer accept applications for certification of non-AIS VHF radios that include channels 75 (156.775 MHz) and 76 (156.825 MHz) as of the effective date of this Report and Order. Finally, the Commission added to Section 80.393 the simplex channels at 156.775 MHz (AIS 3) and 156.825 MHz (AIS 4) and it added to Section 25.202 these bands and the existing AIS bands (161.9625-161.9875 MHz and 162.0125-162.0375 MHz).

45. Allocating the 22.55-23.15 GHz and 25.5-27 GHz Bands to the Space Research Service. The Commission amended the U.S. Table to allocate the 22.55-23.15 GHz band to the SRS (Earth-to-space) on a primary basis for both Federal and non-Federal use and to add a reference to international footnote 5.532A. In addition, the Commission added a primary non-Federal SRS (space-to-Earth) allocation to the companion 25.5-27 GHz band, which currently is allocated to the SRS (space-to-Earth) only for Federal use.

46. Deletion of Aeronautical Mobile Service from the 37-38 GHz Band. The Commission amended the U.S. Table to limit the existing primary mobile service allocation in the 37-38 GHz band only to the land mobile and maritime mobile services. In other words, this primary allocation entry will read “MOBILE except aeronautical mobile” service.

47. Allocating the 7850-7900 MHz Band to the Federal Meteorological-Satellite Service. The Commission allocated the 7850-7900 MHz band to the meteorological satellite-service (MetSat) (space-to-Earth) on a primary basis for Federal use and adopt international footnote 5.461B restricting use of the allocation to non-geostationary systems. As consequence of this action, the larger 7750-7900 MHz band is now allocated to the fixed service and the meteorological satellite-service (space-to-Earth) on a primary basis for Federal use, and per international footnote 5.461B, MetSat use of this band is limited to non-geostationary satellite systems.

48. Allocating the 15.4-15.7 GHz Band to the Federal Radiolocation Service. The Commission allocated the 15.4-15.7 GHz band to the RLS on a primary basis for Federal use. The Commission also added international footnotes 5.511E and 5.511F to the Federal Table, which require that RLS stations operating in the 15.4-15.7 GHz band not cause harmful interference to, or claim protection from, stations operating in the aeronautical radionavigation service, and not exceed the power flux-density level of −156 dB(W/m2) in a 50 MHz bandwidth in the 15.35-15.4 GHz band, at any radio astronomy observatory site for more than 2 percent of the time. Also, the Commission adopted footnote US511E, which limits RLS use of the 15.4-15.7 GHz band to Federal systems requiring a necessary bandwidth greater than 1600 MHz that cannot be accommodated within the band 15.7-17.3 GHz, except that radar systems requiring use of the band 15.4-15.7 GHz for testing, training, and exercises may be accommodated on a case-by-case basis.

49. Other Administrative Matters. The Commission adopted its proposal to update footnote NG49 and renumbered this footnote as NG16. Specifically, the Commission no longer lists the individual frequencies within the footnote, and it removed the geographic restriction from this footnote. These updates will bring the U.S. Table in line with existing service rules. The Commission also amended Section 2.100 of its rules to state that the ITU Radio Regulations, Edition of 2012, have been incorporated to the extent practicable in part 2.

50. The Regulatory Flexibility Act of 1980, as amended (RFA) 1 requires that a regulatory flexibility analysis be prepared for rulemaking proceedings, unless the agency certifies that “the rule will not have a significant economic impact on a substantial number of small entities.” 2 The RFA generally defines “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 3 In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act.4 A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA).5

51. In this Report and Order, the Commission took three actions that will cause a direct cost to regulated entities. First, the Commission required that all commercial fishing vessels that operate radio buoys in the 1900-2000 kHz band be authorized under a ship radio station license. Based on the comments of ITM Marine in ET Docket No. 12-338, there are between 750 and 1000 active commercial fishing vessels that operate such radio buoys.6 The Commission expects that some of these fishing vessels are owned by small businesses that do not already have a ship radio station license. Because the total cost for a ship radio station license is $215, the Commission found that the direct cost of this requirement will be far less than one percent of revenue for any future small business licensee.

52. Second, the Commission required that oceanographic radars, which currently operate under experimental license authority, operate in accordance with the adopted part 90 rules within five years of the effective date of this Report and Order. Based on its review of licenses in the Commission's Experimental Licensing System, the adopted rules will affect nine universities and one manufacturer. Based on information provided by the National Oceanic and Atmospheric Administration, the Commission believes that, in most cases, existing oceanographic radars can transition to the nearest allocated band without major hardware modification.7 The Commission noted that only two of these universities are private institutions (Cornell University and San Francisco University) that meet the definition of small organization, see 5 U.S.C. 601(4). The Commission further noted that there “are 1,600 private, nonprofit institutions nationwide,” 8 and the great majority of these are clearly small organizations. Therefore, the Commission found that requiring oceanographic radars to operate under the adopted part 90 rules will impact far less than one percent of private, nonprofit academic institutions that are small organizations. The Commission also believes that the single licensee that is a manufacturer (CODAR Ocean Sensor, Ltd.) will be positively impacted because it has committed to “produce, sell, and support [oceanographic radars] that operate in all of the ITU allocated bands and conform to any local regulations.” 9

53. Third, the Commission reallocated the 156.7625-156.7875 MHz and 156.8125-156.8375 MHz bands from MMS to the mobile-satellite service, and requires that MMS operations in these bands cease as of August 26, 2019. There is a single licensee (BKEP Materials, LLC) authorized to operate three private coast stations in these bands. Based on its review of licenses in the Commission's Universal Licensing System, the Commission has issued 2770 licenses for private coast stations to operate in the 156-157.1 MHz band. The Commission estimated that at least 1000 of these licensees are small entities. Therefore, the Commission found that these reallocations will impact far less than one percent of the total number of small entities operating in the 156-157.1 MHz band.

54. Therefore, the Commission certified that the requirements of this Report and Order will not have a significant economic impact on a substantial number of small entities. The Commission will send a copy of this Report and Order including this final certification, in a report to Congress pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996, see 5 U.S.C. 801(a)(1)(A). In addition, the Report and Order and this certification will be sent to the Chief Counsel for Advocacy of the Small Business Administration, and will be published in the Federal Register. See 5 U.S.C. 605(b).

55. This Report and Order contains new information collections subject to the PRA, Public Law 104-13. It will be submitted to OMB for review under Section 3507(d) of the PRA. The Commission will publish a separate notice in the Federal Register inviting comment on the new information collection requirements adopted herein. The requirements will not go into effect until OMB has approved it and the Commission has published a notice announcing the effective date of the information collection requirements. In this document, the Commission has assessed the potential effects of the prior notification requirement for amateur service operations in the 135.7-137.8 kHz and 472-479 kHz bands, and found that there will in the great majority of instances be a de minimis paperwork burden for amateur service licensees resulting from the collection of information by the Utilities Telecom Council. Finally, the Commission noted that, because “small entities,” as defined in the Regulatory Flexibility Act of 1980, as amended, are not persons eligible for licensing in the amateur service, this rule does not apply to “small entities.” Therefore, the requirement in the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4), that the Commission seek to further reduce this information requirement burden for small business concerns with fewer than 25 employees does not apply.

56. The Commission will send a copy of this Report and Order to Congress and the Government Accountability Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

57. Pursuant to sections 1, 4, 301, 302, and 303 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154, 301, 302a, and 303, this Report and Order is hereby adopted and the Commission's rules are amended as set forth below.

58. The rule amendments adopted herein shall be effective 30 days after date of Federal Register publication of the Report and Order, except for §§ 97.3, 97.15(c), 97.301(b) through (d), 97.303(g), 97.305(c), and 97.313(k) and (l), because § 97.303(g)(2) contains a new information collection requirement that requires approval by OMB under the PRA. These rules sections shall be effective after the Commission publishes a notice in the Federal Register announcing such approval and the relevant effective date.

59. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Report and Order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

60. It is further ordered that the Commission shall send a copy of this Report and Order in a report to be sent to Congress and the General Accounting Office pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A).

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 2, 15, 25, 80, 90, and 97 as follows: