Federal Register Vol. 80, No.245,

In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the Department of Homeland Security (DHS), U.S. Customs and Border Protection (CBP) is giving notice of a proposed rulemaking that DHS/CBP intends to update its regulations to exempt portions of a system of records from certain provisions of the Privacy Act. Specifically, the Department proposes to exempt portions of the “DHS/CBP-007 Border Crossing Information System of Records” from one of more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements. DHS reissued the current DHS/CBP-007 Border Crossing Information (BCI) System of Records in the Federal Register on May 11, 2015 (80 FR 26937), to provide notice to the public that DHS/CBP is updating the categories of records to include the capture of certain biometric information and Advance Passenger Information System (APIS) records at the border.

CBP's priority mission is to prevent terrorists and terrorist weapons from entering the country while facilitating legitimate travel and trade. To accomplish this mission, CBP maintains border crossing information about all individuals who enter, are admitted or paroled into, and (when available), exit from the United States regardless of method or conveyance. Border crossing information includes certain biographic and biometric information; photographs; certain mandatory or voluntary itinerary information provided by air, sea, bus, and rail carriers or any other forms of passenger transportation; and the time and location of the border crossing. Border crossing information resides on the TECS (not an acronym) information technology platform. DHS/CBP provided notice to the public about the update and expansion of the categories of records as part of DHS's ongoing effort to better reflect the categories of records in its collection of information. DHS/CBP published this updated system of records notice in the Federal Register on May 11, 2015 (80 FR 26937).

CBP is responsible for collecting and reviewing border crossing information from travelers entering and departing the United States as part of DHS/CBP's overall border security and enforcement missions. All individuals crossing the border are subject to CBP processing upon arrival in the United States. Each traveler entering the United States is required to establish his or her identity, nationality, and admissibility to the satisfaction of a CBP officer during the clearance process. To manage this process, CBP creates a record of an individual's admission or parole into the United States at a particular time and port of entry. CBP also collects information about U.S. citizens and certain aliens (in-scope travelers pursuant to 8 CFR 215.8, “requirements for biometric identifiers from aliens on departure from the United States”) upon departure from the United States for law enforcement purposes and to document their border crossing.

DHS is statutorily mandated to create and integrate an automated entry and exit system that records the arrival and departure of aliens, verifies alien identities, and authenticates alien travel documents through the comparison of biometric identifiers (8 U.S.C. 1365(b)). Certain aliens may be required to provide biometrics (including digital fingerprint scans, palm prints, photographs, facial and iris images, or other biometric identifiers) upon arrival in or departure from the United States. The biometric data is stored on the Automated Biometric Identification System (IDENT) information technology platform. IDENT stores and processes biometric data (e.g., digital fingerprints, palm prints, photographs, and iris scans) and links biometrics with biographic information to establish and verify identities. The IDENT information technology platform serves as the biometric repository for the Department, and also stores related biographic information.

Previously DHS established the United States Visitor and Immigrant Status Indicator Technology (US-VISIT) Program to manage an automated entry and exit system. On March 16, 2013, US-VISIT's entry and exit operations (including deployment of a biometric exit system) were transferred to CBP through the Consolidated and Further Continuing Appropriations Act of 2013 (Pub. L. 113-6, H.R. 933). The Act also transferred US-VISIT's overstay analysis function to U.S. Immigration and Customs Enforcement (ICE) and US-VISIT's biometric identity management services to the Office of Biometric Identity Management (OBIM), within the DHS National Protection and Programs Directorate (NPPD). CBP assumed biometric entry and exit operations on April 1, 2013.

CBP has continued to develop mechanisms to collect biometric information from departing aliens since assuming responsibility for US-VISIT's entry and exit operations. During these operations, CBP officers may employ technology (e.g., wireless handheld devices or standalone kiosk) to collect biographic and biometric information from certain aliens determined to be in-scope pursuant to 8 CFR 215.8 “Requirements for biometric identifiers from aliens on departure from the United States” prior to exiting the United States. Biometrics are checked against the IDENT system's watchlist of known or suspected terrorists (KST), criminals, and immigration violators to help determine if a person is using an alias or attempting to use fraudulent identification. Biographic and biometric data is encrypted when it is collected and the data is transmitted in an encrypted format to the IDENT system. The data is automatically deleted from the mobile device after the transmission is complete. The handheld mobile devices incorporate strict physical and procedural controls, such as Federal Information Processing Standard (FIPS)-compliant data encryption; residual information removal; and required authorization for users to sign-in using approved user account names and passwords.

Collection of additional biometric information from individuals crossing the border (such as information regarding scars, marks, tattoos, and palm prints) aids biometric sharing between the Department of Justice (DOJ) Integrated Automated Fingerprint Identification System (IAFIS)/Next Generation Identification (NGI) and the IDENT system. The end result is enhanced access to (and in some cases acquisition of) IAFIS/NGI information by the IDENT system and its users. DHS, DOJ/FBI, and the Department of State (DOS)/Bureau of Consular Services entered into a Memorandum of Understanding (MOU) for Improved Information Sharing Services in 2008. The MOUs established the framework for sharing information in accordance with an agreed-upon technical solution for expanded IDENT/IAFIS/NGI interoperability, which provides access to additional data for a greater number of authorized users.

CBP collects border crossing information stored in this system of records through a number of sources, for example: (1) Travel documents (e.g., a foreign passport) presented by an individual at a CBP port of entry when he or she provided no advance notice of the border crossing to CBP; (2) carriers that submit information in advance of travel through APIS; (3) information stored in the Global Enrollment System (GES) (see DHS/CBP-002 Global Enrollment System (GES) SORN, 78 FR 3441, (January 16, 2013)) as part of a trusted or registered traveler program; (4) non-federal governmental authorities that issued valid travel documents approved by the Secretary of DHS (e.g., an Enhanced Driver's License (EDL)); (5) another federal agency that issued a valid travel document (e.g., data from a DOS visa, passport including passport card, or Border Crossing Card); or (6) the Canada Border Services Agency (CBSA) pursuant to the Beyond the Border Entry/Exit Program. When a traveler enters, is admitted to, paroled into, or departs from the United States, his or her biographical information, photograph (when available), and crossing details (time and location) is maintained in accordance with the DHS/CBP-007 Border Crossing Information SORN.

DHS/CBP updated the categories of records to provide notice that CBP is collecting biometrics such as digital fingerprints, photographs, and iris scans from certain non-U.S. citizens at the time of the border crossing or in support of their use of Global Entry or another trusted traveler program. In addition, CBP updated the categories of records in the SORN to provide notice that CBP plans to collect information regarding scars, marks, tattoos, and palm prints from individuals at the border to aid biometric interoperability between the IAFIS/NGI and the IDENT system. Finally, CBP updated the categories of records associated with APIS transmissions to better reflect the information collected and maintained in the DHS/CBP-007 BCI SORN.

Consistent with DHS's information sharing mission, information stored in the DHS/CBP-007 BCI SORN may be shared with other DHS components that have a need to know the information to carry out their national security, law enforcement, immigration, intelligence, or other homeland security functions.

The exemptions for the system of records notice published May 28, 2013 (78 FR 31958) continue to apply for the updated system of records for those categories of records listed in the previous System of Records Notice. However, this document proposes to exempt portions of certain new categories of records ingested from APIS (see DHS/CBP-005 APIS SORN, 80 FR 13407 (March 13, 2015) claimed for those records in that system pursuant to 5 U.S.C. 552a(j)(2) and 5 U.S.C. 552a(k)(2). Furthermore, to the extent certain categories of records are ingested from other systems, the exemptions applicable to the source systems will remain in effect.

DHS is issuing this Notice of Proposed Rulemaking to exempt portions of DHS/CBP-007 Border Crossing Information System of Records from certain provisions of the Privacy Act.

The Privacy Act embodies fair information practice principles in a statutory framework governing the means by which the Federal Government collects, maintains, uses, and disseminates individuals' records. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of an individual or by some identifying number, symbol, or other identifying particular assigned to the individual. In the Privacy Act, an individual is defined to encompass U.S. citizens and lawful permanent residents. As a matter of policy, DHS extends administrative Privacy Act protections to all individuals when systems of records maintain information on U.S. citizens, lawful permanent residents, and visitors.

The Privacy Act allows government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a Notice of Proposed Rulemaking to make clear to the public the reasons why a particular exemption is claimed.

DHS is claiming exemptions from certain requirements of the Privacy Act for portions of DHS/CBP-007 Border Crossing Information System of Records. Specifically, certain records ingested from the DHS/CBP-005 Advance Passenger Information System (APIS) SORN into the DHS/CBP-007 Border Crossing Information System of Records will continue to be covered by the exemptions claimed for those records in that system pursuant to 5 U.S.C. 552a(j)(2) and 5 U.S.C. 552a(k)(2). Information in DHS/CBP-007 Border Crossing Information System of Records relates to official DHS national security and law enforcement activities. These exemptions are needed to protect information relating to DHS law enforcement investigations from disclosure to subjects of investigations and others who could interfere with investigatory and law enforcement activities. Specifically, the exemptions are required to preclude subjects of these activities from frustrating the investigative process; to avoid disclosure of investigative techniques; protect the identities and physical safety of confidential informants and of law enforcement personnel; ensure DHS's and other federal agencies' ability to obtain information from third parties and other sources; protect the privacy of third parties; and safeguard sensitive information. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension.

In appropriate circumstances, when compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case by case basis.

DHS will not assert any exemption with respect to information maintained in the system that is collected from a person at the time of crossing and submitted by that person's air, sea, bus, or rail carriers, if that person, or his or her agent, seeks access or amendment of such information. The DHS/CBP-007 Border Crossing Information System of Records Notice was published in the Federal Register on May 11, 2015.

For the reasons stated in the preamble, DHS proposes to amend chapter I of title 6, Code of Federal Regulations, as follows:

Under the authority of the AMA (7 U.S.C. 1621-1627), as amended, GIPSA establishes and maintains a variety of quality and grade standards for agricultural commodities that serve as a fundamental starting point to define commodity quality in the domestic and global marketplace. Standards developed by GIPSA under the AMA include rice, whole dry peas, split peas, feed peas, lentils, and beans. The AMA standards are voluntary and widely used in private contracts, government procurement, marketing communication, and, for some commodities, consumer information. The U. S. Standards for Rough Rice, Brown Rice for Processing, and Milled Rice standards were last revised in 2002 and appear in the AMA regulations at 7 CFR 868.202 through 868.316. The standards facilitate the marketing of rice in foreign and domestic trade, and provide a uniform measure of quality by providing a common language to describe commodity attributes for U.S. producers, exporters and their customers. Official procedures for inspections are provided in GIPSA's Rice Inspection Handbook for determining the various grading factors.

GIPSA inspects shipments of rice in accordance with AMA standards to establish the grade of the rice and issues inspection certificates for each shipment. GIPSA-issued certificates describing the quality and condition of graded rice are accepted as prima facie evidence in all Federal courts. U. S. rice standards and the affiliated grading and testing services offered by GIPSA verify that a seller's rice meets specified requirements, and ensure that customers receive the quality of rice they purchased. In addition to Federal usage, the rice standards are applied by one State and one private cooperator.

In order for U. S. standards and grading procedures for Rough Rice, Brown Rice for Processing, and Milled Rice to remain relevant, GIPSA is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U. S. Standards for Rice and inspection procedures.

The '34 Act provides that an entity must register as a transfer agent if it functions as a transfer agent with respect to any security registered under section 12 of the '34 Act (Section 12) or if it would be required to be registered except for the exemption from registration provided by Section 12(g)(2)(B) or Section 12(g)(2)(G).1 A transfer agent registers by filing an application for registration with the appropriate regulatory agency.2 Prior to the enactment of the Dodd-Frank Wall Street Reform and Consumer Protection Act 3 (Dodd-Frank Act), the FDIC was the appropriate regulatory agency only for a state-chartered (State) insured bank that is not a member of the Federal Reserve System and a subsidiary of any such bank, and the Office of Thrift Supervision (OTS) was the appropriate regulatory agency for a State or federal savings association.4

In 2010, the Dodd-Frank Act provided for a substantial reorganization of the regulation of State and Federal savings associations and their holding companies. On July 21, 2011, (the “transfer date” established by section 311 of the Dodd-Frank Act), the powers, duties, and functions formerly assigned to, or performed by, the OTS were transferred to (i) the FDIC, as to State savings associations; (ii) the Office of the Comptroller of the Currency (OCC), as to Federal savings associations; and (iii) the Board of Governors of the Federal Reserve System, as to savings and loan holding companies. The Dodd-Frank Act also amended the '34 Act to define the FDIC as the appropriate regulatory agency for insured State savings associations, and subsidiaries thereof, along with insured State nonmember banks, and subsidiaries thereof.5

In 2012, the JOBS Act increased the thresholds at which securities must be registered under Section 12(g)(1) with the Securities and Exchange Commission (SEC).6 As amended by the JOBS Act, Section 12(g)(1) generally requires securities' issuers to register their securities when the issuer has total assets exceeding $10,000,000 and a class of equity security (other than an exempted security) held of record by either— (i) 2,000 persons or (ii) 500 persons who are not accredited investors (as such term is defined by the SEC).7

The JOBS Act also amended Section 12(g)(1) to provide that in the case of an issuer that is a bank or a bank holding company, the issuer's securities must be registered when the issuer has total assets exceeding $10,000,000 and a class of equity security (other than an exempted security) held of record by 2,000 or more persons.8

Part 341 of the FDIC's regulations (part 341) implements Section 12 of the '34 Act by requiring State nonmember banks and subsidiaries thereof that are transfer agents of qualifying securities to register with the FDIC.9 (Part 341 does not currently include requirements for State savings associations or their subsidiaries.) Part 341 defines “qualifying securities” as securities registered on a national securities exchange; or securities issued by a company or bank with 500 or more shareholders and $1 million or more in total assets, except for securities exempted from registration with the SEC by Section 12(g)(2) (C, D, E, F and H).10 The second prong of the definition of qualifying securities, regarding securities issued by a company or bank with 500 or more shareholders and $1 million or more in total assets, is derived from the statutory requirements in Section 12(g)(1) for registering securities with the SEC.11 As a result of the amendments to the '34 Act made by the Dodd-Frank Act and the JOBS Act, the current exclusion of State savings associations and subsidiaries thereof and the regulatory definition of qualifying securities currently found in part 341 is inconsistent with the statutory threshold for registration requirements now provided in Section 12(g)(1).

The OTS did not issue a rule regarding the registration of securities transfer agents. Instead, the OTS issued a memorandum to covered financial institutions informing such institutions that because of statutory changes in the Financial Services Regulatory Relief Act of 2006,12 savings and loan associations, their subsidiaries, and savings and loan holding companies should register as transfer agents with the OTS rather than the SEC.13 Therefore, this proposed rule would not rescind any regulation issued by the OTS that was transferred to the FDIC following the transfer date.

The proposed rule is part of the FDIC's continuing efforts to enact rule changes required by the Dodd-Frank Act and more recent statutory changes, such as the JOBS Act, and would make it clear that part 341 would apply to insured State nonmember banks, insured State savings associations, and the subsidiaries of such institutions. Expanding the scope of part 341 to include State savings associations is consistent with provisions of the Dodd-Frank Act and serves to increase regulatory consistency for all FDIC-supervised institutions. To that end, the proposed rule would define the term “covered institution” to include an insured State nonmember bank, an insured State savings association, and the subsidiaries of such institutions.

The proposed rule would reconcile the regulatory definition of qualifying securities with the statutory amendments to the '34 Act required by the JOBS Act. The proposed rule would define qualifying securities as (1) securities registered on a national securities exchange pursuant to Section 12(b) (15 U.S.C. 78l(b)) or (2) securities required to be registered under Section 12(g)(1) (15 U.S.C. 78l(g)(1)), except for securities exempted from registration with the SEC by Section 12(g)(2) (C, D, E, F, and H). As such, securities exempted from registration with the SEC by sections 12(g)(2)(B) and (G) of the '34 Act would be included in the definition of qualifying securities. (Section 12(g)(2)(B) of the '34 Act includes securities issued by an investment company registered pursuant to section 8 of the Investment Company Act of 1940 (15 U.S.C. 80a-8), and Section 12(g)(2)(G) refers to securities of certain insurance companies.) Therefore, the proposed definition of qualifying securities would include: (a) Securities registered on a national securities exchange; (b) securities issued by (1) a company with total assets in excess of $10 million and a class of equity securities (other than exempted securities) held of record by either: (i) 2,000 persons, or (ii) 500 persons who are not accredited investors or (2) a bank with total assets exceeding $10 million and a class of equity securities (other than exempted securities) held of record by 2,000 or more persons; (c) securities issued by investment companies registered pursuant to section 15 U.S.C. 80a-8; and (d) securities issued by insurance companies exempt from registration under Section 12(g)(2)(G).

The proposed definition of “qualifying securities” would cite to Section 12(g)(1) instead of reciting specific quantitative standards to ensure that the FDIC's regulations remain consistent with any future statutory changes to Section 12(g)(1) .

The proposed rule would remove the delegations of authorities related to the registration of securities transfer agents from the rule. In the past, the FDIC has taken steps to remove delegations of authority from its regulations in order to provide the agency greater flexibility in the decision-making process.14 The proposed removal of the delegations of authority from the regulation would not change the existing delegation; it would simply move the delegation from the FDIC's regulations. Interested parties may access the FDIC's current delegations of authority on the agency's Web site, at www.fdic.gov.

The proposed rule would also make certain technical corrections to part 341, such as revising outdated citations and updating the name of the FDIC division granted delegated authority to act on disclosure matters.

The FDIC invites comment on all aspects of the proposed rule. Specifically, should the rule include the definition of “qualifying securities” instead of referring to the exemptions in the `34 Act?

In accordance with the requirements of the Paperwork Reduction Act of 1995 (PRA), the agencies may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.15 The FDIC has reviewed the proposed rule and determined that it would not introduce any new collection of information pursuant to the PRA.

The Regulatory Flexibility Act, 5 U.S.C. 601 et seq. (RFA), requires an agency, in connection with a proposed rule, to prepare an Initial Regulatory Flexibility Analysis describing the impact of the proposed rule on small entities (defined by the Small Business Administration for purposes of the RFA to include banking entities with total assets of $550 million or less) or to certify that the proposed rule would not have a significant economic impact on a substantial number of small entities. For the reasons provided below, the FDIC certifies that the proposed rule would not have a significant economic impact on a substantial number of small entities. Accordingly, an initial regulatory flexibility analysis is not required.

The proposed rule would not affect a substantial number of small entities.16 Currently only 17 entities are registered with the FDIC as registered transfer agents. Additionally, the FDIC has not received any new registrations for several years. In fact, over the last 10 years, 18 entities have deregistered as transfer agents (the most recent deregistration was in 2014). Furthermore, if any currently registered transfer agent does not meet the threshold requirements, it could deregister if the proposed rule were adopted as a final rule. Therefore, the proposed rule would likely reduce burden on small entities by increasing the number of entities that could deregister with the FDIC. As such, the proposed rule would not have a significant economic impact on a substantial number of small entities.

Section 722 of the Gramm-Leach-Bliley Act requires the FDIC to use plain language in all proposed and final rules published after January 1, 2000. The FDIC invites comment on how to make this proposed rule easier to understand. For example:

• Has the FDIC organized the material to suit your needs? If not, how could the FDIC present the rule more clearly?

• Are the requirements in the rule clearly stated? If not, how could the rule be more clearly stated?

• Do the regulations contain technical language or jargon that is not clear? If so, which language requires clarification?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the regulation easier to understand? If so, what changes would achieve that?

• Is this section format adequate? If not, which of the sections should be changed and how?

• What other changes can the FDIC incorporate to make the regulation easier to understand?

For the reasons stated in the preamble, the Federal Deposit Insurance Corporation proposes to amend part 341 of chapter III of title 12, Code of Federal Regulations as follows:

Sunlamp products are both “devices” under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(h)), and “electronic products” under section 531(2) of the FD&C Act (21 U.S.C. 360hh(2)). They are designed to incorporate one or more ultraviolet (UV) lamps intended for irradiation of any part of the living human body, by UV radiation with wavelengths in air between 200 and 400 nanometers, to induce skin tanning (see §§ 878.4635(a) and 1040.20(b)(9) (21 CFR 878.4635(a) and 1040.20(b)(9))). Sunlamp products include tanning beds and tanning booths. Sunlamp products, as defined in proposed § 878.4635, do not include—and this proposed rulemaking does not address—ultraviolet lamps for dermatological disorders regulated under 21 CFR 878.4630.1

The FD&C Act establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) defines three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

FDA regulates electronic products under chapter 5, subchapter C, of the FD&C Act (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products.

FDA is undertaking three initiatives to address the risks associated with sunlamp products. First, in a final reclassification order that issued June 2, 2014 (79 FR 31205 at 31213), FDA reclassified sunlamp products and UV lamps intended for use in sunlamp products from class I to class II, and established special controls and premarket notification (510(k)) requirements under the medical device authorities of the FD&C Act. The special controls include performance testing and labeling requirements, including a warning that sunlamp products are not to be used on persons under the age of 18 years.

Second, and simultaneously with this proposed rule, FDA is proposing amendments to the sunlamp products and UV lamps performance standard at § 1040.20, which includes technical and labeling requirements issued under the radiological health provisions of the FD&C Act. As explained elsewhere in this issue of the Federal Register, FDA is taking this action to reflect current scientific knowledge related to sunlamp product use, harmonize it more closely with International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12, and strengthen the warning statement required by § 1040.20(d)(1)(i) in accordance with the results of the study FDA conducted under section 230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85).

Finally, in this action, FDA is proposing device restrictions under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), which authorizes FDA to issue regulations imposing restrictions on the sale, distribution, or use of a device, if, because of its potentiality for harmful effects or the collateral measures necessary to its use, FDA determines that absent such restrictions, there cannot be a reasonable assurance of its safety and effectiveness. The proposed device restrictions would require that:

1. Tanning facility operators permit use of sunlamp products only if the prospective user is age 18 or older;

2. Tanning facility operators, upon request by the user or prospective user, provide a copy of the sunlamp product user manual or name and address of the manufacture or distributor from whom a user manual may be obtained;

3. 510(k) holders assure that a user manual accompanies each sunlamp product and, upon request, provide a copy of the user manual to any tanning facility operator, user or prospective user; and

4. Tanning facility operators obtain each prospective user's signature on a risk acknowledgement certification.

These device restrictions would primarily apply to tanning facility operators, and to a lesser extent, device manufacturers and distributors. FDA considers a tanning facility operator to be any person offering for sale the use of sunlamp products. FDA would not consider people who use their own tanning beds (home users) to be tanning facility operators.

Certain provisions of the FD&C Act relate specifically to FDA's authority over restricted devices. For example, sections 502(q) and (r) of the FD&C Act (21 U.S.C. 352(q) and (r)) provide that a restricted device distributed or offered for sale in any state shall be deemed to be misbranded if its advertising is false or misleading or fails to include certain information regarding the device, or it is sold, distributed, or used in violation of regulations prescribed under section 520(e), and section 704(a) of the FD&C Act (21 U.S.C. 374(a)) authorizes FDA to inspect certain records relating to restricted devices.

If this proposed rule becomes final, it may be enforced by means of seizure of the sunlamp product, under section 304 of the FD&C Act (21 U.S.C. 334); a suit for injunction, under section 302 of the FD&C Act (21 U.S.C. 332); imposition of civil money penalties, under section 303 of the FD&C Act (21 U.S.C. 333); or criminal prosecution, under section 303 of the FD&C Act. FDA expects to cooperate with counterpart agencies at the state level in enforcing the proposed requirements, if they become final. Consumer complaints to FDA and State Agencies would be important in identifying entities that violate the conditions for sale or use of these devices.

The General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (2010 Advisory Panel) met on March 25, 2010, to review and discuss recent information regarding the risks to the general public from exposure to sunlamp products, and identified the following risks to health for sunlamp products.2 These risks are well documented and discussed in published literature.

UV radiation exposure can lead to permanent damage to DNA in the skin, which has been shown to lead to an increased risk of skin cancer (Refs. 1-3). Skin cancers that have been associated with cumulative repeated UV radiation exposure include melanoma and non-melanoma skin cancers (NMSC) such as basal cell carcinoma and squamous cell carcinoma (Ref. 4). One study suggests that doses of UV-A radiation emitted by high power sunlamp products may be up to 10 to 15 times higher than that of the midday sun, resulting in an intense amount of exposure that does not exist in nature (Ref. 5). Users with a personal history of melanoma have an increased risk of skin cancer, as do users with familial melanoma—having one first-degree relative with melanoma doubles one's risk of developing melanoma (Refs. 6, 7). There is also evidence suggesting that individuals who begin indoor tanning at ages younger than 18 years are particularly vulnerable to the carcinogenic impact of indoor tanning (see section III.A for further discussion).

UV and visible radiation from sunlamp products can be harmful to the eyes if proper protective eyewear is not worn. The UV radiation from sunlamp products can cause keratitis and corneal burns, which can be painful and affect vision (Ref. 8). The intense visible light from some sunlamp products can damage the retina and permanently affect vision (Ref. 8). Artificial UV radiation has also been linked to ocular melanoma, which can cause vision loss and often spreads to other parts of the body (Ref. 9).

A recent study showed that, despite protective properties touted by commercial tanning facilities such as claims that indoor tanning limits exposure time and intensity, 66 percent of female college-age users reported skin erythema (or redness due to sunburn) from indoor tanning, and these users reported one episode of sunburn out of every five tanning sessions (Ref. 10). Those findings are in line with a previous report that found that 58 percent of sunlamp product users ages 11 years to 18 years had experienced sunburns from exposure to sunlamp products (Ref. 11).

In certain individuals who are photosensitive, skin exposure to UV radiation may induce unexpected reactions such as rash, severe burns, and hypersensitivity (Ref. 12). Various drugs may cause a photosensitivity reaction in the skin. Some drugs may cause a phototoxic reaction when they absorb UV-A radiation and cause cellular damage. These drugs include anti-infective drugs such as tetracyclines and fluoroquinolones, cardiovascular drugs like hydrochlorothiazide and amiodarone, psychiatric drugs such as phenothiazines, and retinoids such as isotretinoin (Ref. 13). Some dietary supplements may also cause photosensitivity (Ref. 13).

Sunlamp products, like most light sources, generate heat that can cause thermal skin burns, similar to any hot surface. Individuals with open wounds or lesions are particularly susceptible to burns from UV radiation because these individuals lack the protective epidermal layer of the skin that provides the body's greatest protection from UV irradiation (Ref. 14).

Cumulative, repeated exposure to UV radiation emitted by sunlamp products may lead to accelerated aging of skin due in part to DNA and skin cell damage (Ref. 15). UV irradiation inhibits the production of collagen precursor molecules such as type I and type III procollagen (Ref. 16). UV irradiation stimulates skin metalloproteinases, which break down skin proteins that then lead to photoaging (Ref. 17). On a cellular level, UV radiation has been known to cause DNA damage (Ref. 1).

FDA is proposing the following restrictions which, because of the potential for harmful effects from the device, are necessary for a reasonable assurance of safety and effectiveness of sunlamp products:

Although the risks associated with sunlamp products are applicable to all persons, FDA is proposing to restrict the use of this device to persons age 18 and older because children and adolescents who are exposed to UV radiation may be at higher risk of developing certain types of skin cancer than persons who begin exposure later in life as adults (Ref. 18). In the final reclassification order for this device, FDA established special controls labeling regarding minors' use of sunlamp products and UV lamps intended for use in sunlamp products (see § 878.4635(b)(6)). Based on the increased risk of developing skin cancer and minors' difficulty in appreciating the risks posed by the devices (see Refs. 19 to 24), FDA has determined that use of sunlamp products by minors is not appropriate and is therefore establishing a proposed restriction in this rulemaking action to complement the special controls labeling.

Published medical evidence demonstrates that there is a direct correlation between sunlamp product use among youths and their developing melanoma skin cancer, as well as other skin cancers (Refs. 25, 26). Melanoma is a leading cause of cancer death in women ages 15 years to 29 years and there is some evidence that suggests use of sunlamp products is an underlying cause (Refs. 27, 28).

There is increasing epidemiological evidence that shows that tanning at ages younger than 18 years increases the risk of developing melanoma (Refs. 25, 29 to 32). Melanoma (of the types of skin cancer, this is the more concerning type due to greater potential for fatality) is currently the second leading type of cancer in persons age 20 years to 39 years, and many experts believe that at least one cause for this is the increasing use of sunlamp products (Refs. 30, 33). A 2009 International Agency for Research in Cancer (IARC) report linked UV exposure (including from indoor tanning devices) by individuals under age 35 to higher rates of melanoma as compared to a similar cohort of individuals who had not used sunlamp products, and recommended that minors not use sunlamp products. Similarly, a meta-analysis by Gallagher et al. that evaluated metrics of sunlamp product exposure, including in young adults, indicated a significantly increased risk of cutaneous melanoma subsequent to sunlamp product exposure (Ref. 34). In particular, the analysis showed a positive association between first exposure as a young adult and subsequent melanoma. Further, a case control study in Connecticut found a relative risk of 1.4 for melanoma diagnosis when individuals are exposed to sunlamp products before the age of 25 (Ref. 35).

In addition, there is increasing epidemiological evidence that shows that tanning at ages younger than 18 years increases the risk of developing NMSC. For example, recent studies found a significantly higher risk for basal cell carcinoma for individuals who used sunlamp products during high school and college as compared to those who used sunlamp products between the ages of 25 and 35 (Refs. 36, 37).

Individuals under 18 who are exposed to UV radiation are at an increased risk of developing skin cancer because (1) there is evidence suggesting that they are particularly vulnerable to the damaging effects of UV radiation and (2) the cumulative effects of exposure have been linked to higher incidence of skin cancer. First, evidence suggests that minors exposed to UV radiation are particularly vulnerable to developing skin cancer (Ref. 38). In particular, migration studies compare people who moved from less UV-intense environments to more UV-intense environments at a young age, for example, children who moved from the United Kingdom to Australia. A number of biological factors, such as skin development and formation of nevi at a young age, are identified as potentially causing the increase in the risk of developing melanoma from exposure to UV radiation, like that from sunlamps (Refs. 18, 39). Second, as with other radiation exposure, increased cumulative lifetime UV exposure results in increased skin cancer risk (Ref. 40).

The age restriction also is necessary because individuals under 18 often fail to appropriately evaluate the significant health risks associated with indoor tanning. For example, a study has shown that college age students often use sunlamp products despite awareness of the long-term risks (Refs. 41 to 43). Rather, persons under age 18 years appear to be discounting whatever risk information they are receiving or may have difficulty incorporating the information into their decisionmaking. For example, a recent study links indoor tanning by high school students to other risk-taking behaviors, including binge-drinking, unhealthy weight control, sexual intercourse, and illegal drug or steroid use (Ref. 20). This linkage suggests that, like other risk-taking behaviors, adolescents use sunlamp products for self-esteem or sensation seeking reasons, irrespective of known health risks (Ref. 20). Similarly, another recent study showed that psychosocial and demographic characteristics strongly correlated with adolescent indoor tanning (Ref. 22). By restricting sunlamp product use to individuals 18 and older, we would be protecting a subpopulation that generally tends to discount risk information and favor risk taking.

Based on the scientific evidence available at the time, some members of the 2010 Advisory Panel recommended an age restriction to preclude use by persons under 18 years of age to reduce the unintended health effects of these devices (Ref. 44). The scientific literature published since that meeting, as described in this document, offers further support for an age restriction (Refs. 20, 22, 41).

Various professional organizations also support an age restriction on sunlamp product use. The World Health Organization (WHO) has classified UV radiation from sunlamp products as a class I carcinogen based on the 2009 IARC report that linked sunlamp product use by individuals under age 35 to higher rates of melanoma and strongly urged consideration of restricting minors from using sunlamp products (Ref. 45). Accordingly, the WHO recommends that persons under age 18 not use sunlamp products (Ref. 46).

The American Academy of Dermatology (AAD) recognizes WHO's declaration that sunlamp products are cancer-causing agents and are in the same risk category as tobacco, and supports the position that minors should not use sunlamp products (Ref. 47). In 2011, the American Academy of Pediatrics published a policy statement similar to that of the AAD calling for a restriction on sunlamp product use by minors (Refs. 48, 49).

Experts in pediatrics, public health, and dermatology also support a legislative age restriction on sunlamp product use. For example, recent studies cited other peer reviewed articles to examine the effects of legislation on indoor tanning use (Refs. 22, 50, 51). They concluded that an age restriction or ban would be far more effective at reducing youth indoor tanning than other potential actions such as parental consent (Refs. 22, 50, 51).

This scientific evidence also has led many State and foreign governments to institute age restrictions in the last few years on the use of sunlamp products by minors (Ref. 50). To date, more than 40 states have age restrictions on sunlamp product use (Ref. 52). These restrictions have age limits ranging from ages 14 to 18. At least 11 countries have restricted the use of sunlamp products to adults age 18 and older, including Great Britain and France (Refs. 52 to 54).

Restricting use of these devices to individuals 18 and over should reduce future morbidity and mortality from melanoma and other skin cancers and would help to protect the public health, according to both expert advisory opinion and findings from current scientific, medical, and public health policy literature (Ref. 54). In the journal Health Policy in 2009, Hirst et al. estimated that preventing minors from indoor tanning has the potential to reduce the incidence of skin cancers and related medical costs (Ref. 54).

This restriction is particularly important because, as previously discussed, it has been shown that increased knowledge of the risks of UV exposure among adolescents and young adults does not appreciably alter their tanning behavior and attitudes (Refs. 19, 41, 42, 55). The use of sunlamp products has been suggested to have both a psychological reinforcing effect in minors due to feedback from others on minors' cosmetic appearance or self-perceptions that leads to continued or increased use, in addition to the physical reinforcing effect that has been linked to high rates of use (Refs. 19, 56).

This age restriction is also important because parental awareness of the risks, educational campaigns, and parental consent to the risks, on their own, have been shown to be insufficient in reducing indoor tanning in young age groups (Refs. 21, 22, 41).

The risks associated with use of sunlamp products by individuals under 18 are particularly concerning given the widespread use of these devices among high school students. The Centers for Disease Control and Prevention has documented high rates of use in U.S. high school students from its 2011 Behavioral Risk Survey: 13 percent of all high school students report indoor tanning, and 29 percent of white female high school students report usage in the last year (Ref. 53). There are a number of collaborative studies that have demonstrated that young women, in particular, use sunlamp products at increasingly high rates (Refs. 22 to 24, 57). For example, one study found that indoor tanning usage (defined as tanning during the previous 12 months) progressively increased in adolescents (age 14-17) from 5.5 percent at age 14 to 16.5 percent at age 17, which suggests that adolescents use indoor tanning more often as they get older (Ref. 22). Another study analyzed the results of a survey of over 10,000 U.S. individuals age 12 years to 18 years and found nearly 10 percent of respondents used a sunlamp product during the previous year and rates increased to 35 percent for females by age 17, highlighting that teenage girls are more likely than their male counterparts to use indoor tanning facilities (Ref. 24).

FDA seeks comments on its proposal to restrict use of these devices to individuals 18 years of age and over as well as data and information in support of any comments. In addition, although FDA has strong reservations about a parent-consent process in this setting, we recognize parents' decision-making role. We welcome comment on parental consent and its potential scope, including comments on experiences in jurisdictions that have a parental consent provision for use of sunlamp products.

User manuals provide valuable information to operators and users. Sunlamp product user manuals can include vital information such as instructions for use, exposure schedules, maintenance guidance, and device warnings. In order to help ensure the dissemination of this important information to sunlamp product users, FDA is proposing that tanning facility operators be required to provide a copy of the user manual or the name and address of the manufacturer or distributor that can provide a copy of the user manual to any user or prospective user that requests one. Similarly, FDA is also proposing that 510(k) holders be required to provide user manuals to any tanning facility operator, user, or prospective user that requests one. The electronic product performance standard currently requires manufacturers to provide manuals to purchasers and, upon request, to others for the life of the sunlamp product (see § 1040.20(e)). FDA believes that access to the information contained in the user manual would help prospective users make informed decisions when considering whether to use the device and would also inform tanning facility operators and users on how to use the device properly.

FDA is proposing that tanning facility operators would have to provide, and sunlamp product prospective users 18 and older would have to sign, the certification set forth in proposed § 878.4635(c)(4) prior to use of any sunlamp product, unless the prospective user has previously signed the risk acknowledgement certification within the preceding 6 months. The certification provides warnings regarding sunlamp products as well as information regarding the proper use of the devices. By making this information available to users in a direct and accessible manner, the certification would better enable consumers to make informed decisions about their use of sunlamp products. Moreover, and as discussed more fully in this section III.C, the information could counteract any false or misleading information that sunlamp product users may have received regarding the risks of indoor tanning.

Compliance with this proposed requirement would not be unduly burdensome for tanning facilities. The certification has already been drafted by FDA and, as discussed in the economic analysis in Docket FDA-2015-N-1765 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 58), tanning facility operators would need only a brief amount of time to explain to the user the purpose of the certification and to process or file the signed certification. Reading and signing the certification would not be overly burdensome for prospective users—the user would need only a brief amount of time to read and sign the form, if they choose to proceed (Ref. 58).

FDA proposes that the text of the risk acknowledgement certification would have to be at least 10-point font and that the tanning facility operator would have to provide a copy of the signed acknowledgement certification to the prospective user and retain a copy of the signed acknowledgement certification for 1 year or until the prospective user signs a new risk acknowledgement certification, whichever is sooner. The statements in the certification are intended to inform prospective users of the risks they may be exposing themselves to by using the device and the inherent risks posed by UV radiation, as well as provide information regarding the proper use of the device.

When developing the certification, FDA aimed to inform readers of the most serious risks in a clear and succinct manner in order to promote rapid comprehension and not take more time than necessary for the key information to be conveyed and understood. Readability analysis, human participants' usability testing, and human factors/risk communication analysis were conducted on the certification to ensure the certification achieved its intended goals clearly and succinctly (Refs. 58 and 59). After obtaining feedback from the testing, the certification was revised consistent with recommendations made in the testing and is presented in this proposed rule with its refined content and format. FDA welcomes comment on the proposed certification form.

Unlike a label that must be affixed to a device (see § 878.4635(b)(6)(i)(A)), a risk acknowledgement certification can include more comprehensive warnings to ensure that users are aware of the risks associated with the use of the devices (Refs. 50 and 59). FDA expects that users will consider the risks carefully when signing the certification. If users were provided the certification but not required to sign it, they would be less likely to read the risk information in the certification, and they may even opt not to read the certification, mistakenly thinking that it was promotional material provided by the tanning facility.

Members of the 2010 Advisory Panel recommended that sunlamp product users be required to read and sign an acknowledgement of risks related to sunlamp products before using the device. Since this meeting, FDA has become aware of additional information regarding the use of sunlamp products that further supports the need for risk acknowledgement certifications.

There are reports in the literature that document tanning facility operators failing to inform patrons of certain risks, causing various groups to call for “informed consent” or better informing users at indoor tanning facilities (Ref. 60).

In keeping with the literature, on February 1, 2012, staff of the U.S. House of Representatives Committee on Energy and Commerce released a report summarizing their findings regarding false and misleading information provided to patrons of indoor tanning salons, especially teenage women. They found, for example, that 90 percent of operators responded that indoor tanning presented no risks (Ref. 61). When pressed about skin cancer specifically, more than half of the operators claimed indoor tanning would not increase the risk (Ref. 61). Some operators who did inform their patrons of skin cancer risks nevertheless mischaracterized the magnitude and the vulnerable subpopulations (Ref. 60). Other operators provided misleading benefit information, including claims that indoor tanning would protect patrons from cancer or beneficially create vitamin D (Ref. 61).

These reported practices support the need for risk acknowledgement certifications, which could counteract any false or misleading information communicated to prospective users. This risk acknowledgment will provide prospective users with accurate information about the risks and proper use of the devices so that they can make informed decisions about their use of these devices.

The Agency has determined that under 21 CFR 25.34(f) this proposed action will not result in increases in the existing levels of use or changes in the intended uses of the product or its substitutes. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). OMB has determined that this proposed rule is a significant regulatory action as defined by Executive Order 12866.

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. We believe this proposed rule would result in a significant impact on a substantial number of small entities, but the impacts are uncertain.

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

The proposed rule would restrict the use of sunlamp products to individuals aged 18 years and over and require all prospective users to read and sign a risk acknowledgement certification before use (unless the prospective user has previously signed the form within the preceding 6 months). The social benefits from this proposed rule stem from a potential reduction in the incidence of skin cancer. The social costs of the proposed rule are associated with the value of time spent by users and tanning facility operators on the risk acknowledgement certifications and verifying proof of age, as well as other compliance costs. As discussed more fully in the complete assessment, analyzing the impact of the proposed rule is difficult because of the uncertainty of how users would be affected by reading and signing the risk acknowledgment certification and how nonuse when under 18 years of age would affect later adult use. Because of this uncertainty, we use a 1 to 10 percent range in the response rate to the risk information and age restriction, assuming that the age restriction reduces future tanning. Under these scenarios, assuming a discount rate of 7 percent the annualized cost over 10 years would range from $104 million to $114 million; annualized benefits would range from $70 to $115 million. With a 3 percent discount rate the annualized cost over 10 years would range from $122 million to $144 million; annualized benefits would range from $151 to $248 million.

In addition to the social costs, the proposed rule would likely generate distribution effects from the reduced demand for tanning services. The annualized reduction in indoor tanning revenues would range from about $500 million to $820 million at a 7 percent discount rate over 10 years and from about $500 million to $825 million at a 3 percent discount rate.

Tanning salons and most of the other establishments who offer commercial tanning services are classified as Other Personal Care Services under the North American Industry Classification System (NAICS 812199). We do not have information on the size distribution of this industry but most, if not all, entities are small businesses. There are 18,000 to 19,000 indoor tanning salons and 15,000 to 20,000 other facilities that offer indoor tanning services. The proposed rule would have a significant impact on a substantial number of small entities chiefly due to the loss of revenue.

The full assessment of the economic analysis is available in Docket FDA-2015-N-1765 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 62). Table 2 summarizes the analysis.

The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on November 28, 1990, transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of the Public Health Service Act to Chapter V, subchapter C of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products.

A sunlamp product is a device that emits UV radiation to induce tanning. The device incorporates one or more UV lamps as a radiation source. Examples of sunlamp products are tanning beds, which are used while lying down, and tanning booths, which are used while standing. UV radiation-emitting products not used for tanning would not be affected by this proposed rule. Devices emitting UV radiation to treat dermatological disorders are regulated separately and are not part of this proposed rule. As electronic products, sunlamp products are subject to the regulations for electronic product radiation control, including parts 1000 to 1010 (21 CFR parts 1000 through 1010) and § 1040.20 (21 CFR 1040.20).

Sunlamp products emit UV radiation to induce tanning. The adverse effects of UV radiation are well known. UV radiation can cause acute injuries such as sunburns and eye irritations (e.g., photokeratitis). Long-term UV exposure has been associated with skin cancer (including squamous cell carcinoma, basal cell carcinoma, and melanoma), skin aging, and cataracts. Epidemiological studies of the effects of UV radiation on incidence of cancer and other health problems are complicated by latency between exposure and disease, difficulty controlling for environmental exposure to UV radiation, and other factors. Nevertheless, a recent meta-analysis found an increase in the risk of melanoma for each additional session of sunlamp product use per year (Ref. 1).

FDA is concerned about the safety risks from UV radiation. Therefore, FDA is updating our requirements for sunlamp products which allow for indoor exposure to UV radiation. There have been many changes in our understanding of how UV radiation interacts with human skin since FDA published the document entitled “Sunlamp Products; Performance Standard” in the Federal Register of September 6, 1985 (50 FR 36548). There have also been many changes in the indoor tanning industry which affect the type of equipment on the market and the measurement techniques used by manufacturers. FDA is updating requirements for sunlamp products to bring our regulations up to date with current science. FDA also wants to improve consumers' understanding of the risks related to UV radiation exposure.

The objective of this proposed rule is to align the performance standards for sunlamp products with current scientific knowledge and our understanding of how these products are used. This proposed rule seeks to facilitate compliance, improve awareness among operators and consumers about risks of use, and ultimately improve public health.

FDA proposes to incorporate certain elements of the International Electrotechnical Commission (IEC) International Standard 60335-2-27, Ed. 5.0: 2009-12, “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,” by reference. Harmonizing the FDA standard with the current IEC standard would bring it up to date with current science and better protect consumers from the risks posed by these devices. Harmonization would have benefits for sunlamp product manufacturers as well. Currently, many firms producing sunlamp products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning these standards would mean that such firms would need to comply with a single set of rules instead of two different ones, at least for the particular clauses which are being adopted and incorporated by reference.

FDA proposes to amend the requirements of part 1002 as specified in table 1 to require that manufacturers of UV lamps intended to be used in sunlamp products are subject to the same record and reporting requirements as manufacturers of sunlamp products. FDA wants to ensure that all test data necessary to ensure compliance with § 1040.20 are collected and maintained. Currently, manufacturers of UV lamps are required to submit only product reports. Under proposed § 1002.1, manufacturers of UV lamps would also be required to submit supplemental reports and annual reports and to maintain test records and distribution records. Moreover, proposed § 1002.1 would also require that manufacturers of protective eyewear maintain test records demonstrating that the eyewear complies with applicable UV and visible transmittance requirements as well as distribution records. In addition, proposed § 1002.1 would also require that manufacturers of protective eyewear submit annual reports, supplemental reports, and product reports to FDA.

Proposed § 1040.20(c)(1) would set an absolute limit for UVC radiation. An absolute limit on UVC (200-290 nanometer (nm)) irradiance would provide greater assurance of user safety because a ratio permits higher doses of UVC (as long as they correspond to higher doses in the 260 to 320 nm range). UVC, which is not present in sunlight that reaches the Earth's surface, is potentially harmful to users while less effective for tanning than UVA or UVB. FDA has chosen not to adopt the limit for UVC radiation in Ed. 5.0 of IEC 60335-2-27 because this limit is 10 times lower than the limit in Ed. 4.2 and FDA believes that it would be difficult for some manufacturers to measure irradiance at this level.

Proposed § 1040.20(c)(2)(ii) would limit the maximum timer interval to one that would result in a biologically effective (also referred to as erythemal-effective) dose that would not exceed 500 joules/meter2 (J/m2) which is approximately equivalent to the 624 J/m2 value (weighted with the CIE LYTLE action spectrum) that was specified in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule. FDA has determined that a dose of 500 J/m2 (weighted with the CIE erythemal action spectrum) provides a biologically equivalent dose that is more closely matched to the current 624 J/m2 value than does the IEC dose limit of 600 J/m2.

Proposed § 1040.20(c)(3) would add a requirement that the control enabling manual termination of radiation emission (sometimes referred to as the “panic button” or “emergency stop”) be easily accessible and readily identifiable to the user. This would ensure that users could easily turn the sunlamp product off for any reason.

Proposed § 1040.20(c)(4)(ii) would expand application of the performance requirements to all protective eyewear intended to be used with sunlamp products, whether sold together with a sunlamp product or sold separately. UV wavelengths can cause serious eye damage, and exposure to the shorter wavelength region of the UV spectrum is especially dangerous. The spectral transmittance requirements for protective eyewear are necessary to protect users of sunlamp products from these risks, which directly result from the UV radiation emitted by the sunlamp product.

Proposed § 1040.20(d)(1)(i) would modify the warning statement required to appear on the label of all sunlamp products. FDA believes that the current warning statement is too long, not user-friendly, and that its content and format could be improved to more effectively communicate the risks of indoor tanning to users. Based on its analysis of the consumer testing, FDA concluded that the current warning statement could be made more effective by changing its required language, formatting, and location. FDA believes that the proposed warning statement would most effectively convey the risks of indoor tanning to users.

The proposed rule would also improve user safety by adopting the IEC's “equivalency code” system for ensuring compatibility between sunlamp products (e.g., tanning beds and booths) and the UV lamps that are used in them. Proposed § 1040.20(d)(1)(vi) would require the label of all sunlamp products to indicate the equivalency code range of the UV lamp to be used in the sunlamp product. Proposed § 1040.20(d)(2)(ii) would require the label of each UV lamp to indicate its UV lamp equivalency code. FDA believes the adoption of the IEC's absolute rating system for replacement UV lamps would eliminate confusion regarding proper lamp replacement, facilitate the enforcement of lamp compatibility requirements, and improve the safety of sunlamp products.

Proposed § 1040.20(d)(3) would retain the requirement of the current FDA standard that the required label information must be legible and readily accessible to view by a sunlamp product user immediately prior to use. Proposed § 1040.20(d)(3)(i) would incorporate specifications into the rule regarding the location, spacing, and font of the required warning statement. FDA believes that these label specifications would ensure that users see the required warning prior to use, and would result in a more comprehensive and effective standard.

Proposed § 1040.20(e)(3) would add a requirement for the provision of the required warning statement in all catalogs, specification sheets, and descriptive brochures intended for consumers in which sunlamp products are offered for sale, and on all consumer-directed Web pages on which sunlamp products are offered for sale. This requirement would ensure that consumers are fully informed of the risks presented by sunlamp products at the time they consider purchasing it.

Proposed § 1040.20(g) is also modeled after the proposed FDA Performance Standard for Laser Products (78 FR 37723, June 24, 2013). FDA believes the addition of these requirements, which have been used successfully over the past two decades for laser products, would improve safety by ensuring that modifications that affect performance would be held to the same standards as original manufacturing.

Estimated one-time costs are $20,917 to $113,240 and annual costs are $4,686 to $7,230. The present discounted costs are $57,181 to $151,390 at 7 percent and $61,498 to $165,883 at 3 percent. Annualized at 7 percent over 10 years, total costs are $8,141 to $21,498. At 3 percent, annualized total costs are $7,867 to $19,447.

The primary benefit of the proposed rule would be from reduced injuries, including sunburn, photokeratitis, skin cancer, cataracts and ocular melanoma, and from reduced exposure to UV radiation. We are unable to quantify the benefits, but where possible, demonstrate that they satisfy breakeven tests using very conservative assumptions. The benefits of this proposed rule would justify the costs.

The Safe Medical Devices Act of 1990 (Pub. L. 101-629), enacted on November 28, 1990, transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of the Public Health Service Act to Chapter V, subchapter C of the FD&C Act (21 U.S.C. 360hh et seq.). Under these provisions, FDA administers an electronic product radiation control program to protect the public health and safety. This authority provides for developing, amending, and administering radiation safety performance standards for electronic products, including sunlamp products.

Until recently, sunlamp products intended for tanning were class I medical devices and exempt from premarket notification requirements, subject to the limitation in 21 CFR 878.9 (see 53 FR 23856, June 24, 1988; 59 FR 63005, December 7, 1994). On March 25, 2010, FDA held a meeting of the General and Plastic Surgery Devices Panel of the FDA/Center for Devices and Radiological Health (CDRH) Medical Devices Advisory committee to seek input on whether the classification or regulatory controls needed to be changed. For a summary of this meeting, see http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/GeneralandPlasticSurgeryDevicesPanel/UCM206522.pdf. On June 2, 2014, based on the panel's recommendations, among other things, FDA reclassified UV lamps intended to tan the skin from class I and exempt from premarket notification to class II and subject to premarket notification, and renamed them sunlamp products and UV lamps intended for use in sunlamp products (see 21 CFR 878.4635; 79 FR 31205, June 2, 2014).

As electronic products, sunlamp products are subject to the regulations for electronic product radiation control, including parts 1000 through 1010 and § 1040.20. The sunlamp products performance standard in § 1040.20 was originally published in the Federal Register on November 9, 1979 (44 FR 65352). In the Federal Register of September 6, 1985 (50 FR 36548), FDA amended § 1040.20 and made it applicable to all sunlamp products manufactured on or after September 8, 1986.

FDA also issued several policy letters pertaining to specific aspects of its regulation of sunlamp products. On June 25, 1985, FDA issued a policy letter entitled “Policy on Warning Label Required on Sunlamp Products” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf) (Ref. 2). This document pertained to the location, spacing, and legibility of the required warning label. On August 21, 1986, FDA issued a policy letter entitled “Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095333.pdf) (Ref. 3). This document explained the criteria FDA uses to evaluate the adequacy of the exposure schedule and the recommended maximum exposure time for sunlamp products. On September 2, 1986, FDA issued another policy letter entitled “Policy on Lamp Compatibility,” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM095325.pdf) (Ref. 4). This document listed the criteria FDA uses to evaluate appropriate replacement lamps for sunlamp products.

Before prescribing any electronic product performance standards, FDA is required to consult a statutory advisory committee, the Technical Electronic Product Radiation Safety Standards Committee (TEPRSSC). See section 534(f)(1)(A) of the FD&C Act (21 U.S.C. 360kk(f)(1)(A)). At the September 23 and 24, 1998, meeting of TEPRSSC, FDA presented general concepts for amendments to the performance standard for sunlamp products, which are embodied in this proposed rule. The committee recommended that FDA pursue development of the amendments.

On February 9, 1999, CDRH published an Advance Notice of Proposed Rulemaking (ANPRM) (Docket No. 98N-1170), 64 FR 6288 (February 9, 1999), for the following reasons:

1. FDA was concerned that inadequate attention was being given to recommended exposure schedules, which are designed to minimize consumer risk.

2. FDA was concerned that the warnings for sunlamp products were not reaching many users of sunlamp products prior to their purchase and use, and that purchasers may not be aware of the risks associated with UV exposure from sunlamp products.

3. Sunlamp products technology has changed since the FDA Performance Standard was amended in 1985. These changes can affect both the intensity and spectral characteristics of the UV emission from sunlamps.

4. Because there is no uniform grading/rating system, choosing a replacement lamp can be confusing for sunlamp product owners and tanning facilities. It also makes the job of tanning facility inspectors more difficult because they cannot easily verify whether the correct lamps are installed in the sunlamp products. The use of incorrect replacement lamps can lead to sunburns.

The specific amendments under consideration were as follows:

1. Harmonizing the sunlamp product performance standard with IEC Standard 60335-2-27;

2. Revising and updating the August 21, 1986, guidance entitled “Policy on Maximum Timer Interval and Exposure Schedule for Sunlamp Products,” and incorporating the updated guidance into the sunlamp product performance standard;

3. Adding a provision clarifying that “manufacturing” under the FD&C Act includes a modification of a sunlamp product that affects any aspect of its performance or intended function for which § 1040.20 has an applicable requirement;

4. Updating the warning statement required by § 1040.20(d)(1)(i) to simplify the wording and to highlight the risk of developing skin cancers;

5. Requiring reproduction of the text of the warning statement specified in § 1040.20(d)(1)(i) in catalogs, specification sheets, and brochures; and

6. Developing a biological efficacy rating scale for UV lamps intended for use in sunlamp products to simplify appropriate lamp replacement.

In response to this ANPRM, FDA received 26 comments from State and local radiation control agencies, manufacturers, the American Academy of Dermatology, the Skin Cancer Foundation, an industry educational association, a tanning facility owner, and a trade organization. FDA considered these comments in developing this proposal.

FDA presented recommendations for amendments to the sunlamp performance standard to TEPRSSC on June 21, 2000. FDA explained to TEPRSSC that it was prepared to move forward with some of the amendments at that time, but did not have sufficient scientific data to move forward with the lamp classification or the exposure schedule amendment. TEPRSSC advised FDA to develop scientifically-based exposure schedule guidelines before incorporating these requirements into the Performance Standard itself. FDA scientists obtained special funding from FDA's Office of Women's Health to conduct this research. Upon completion, FDA presented guidelines for exposure schedules to the IEC TC (Technical Committee) 61, MT (Maintenance Team) 16 that is responsible for developing standards for these products. The IEC accepted these guidelines and incorporated them into IEC 60335-2-27 standard (Ed. 5.0), which published on December 14, 2009.

In February 2002, FDA held a 2-day meeting with the indoor tanning industry and representatives from the U.S. Army Environmental Hygiene Agency, Health Canada, the Swedish Radiation Protection Institute, and the North Carolina Department of Radiation Protection. The purpose of this meeting was to solicit input from the affected parties on the lamp equivalence issue and other possible amendments to the FDA Performance Standard for Sunlamp Products, which we considered in the development of this proposed rule.

The IEC TC 61, MT 16 committee met in October 2002, and decided to work with IEC SC (subcommittee) 34A to develop practical standardized test methods and a classification scheme for low-pressure, fluorescent tanning lamps to facilitate replacement of these lamps when they wear out. IEC SC 34A has responsibility for the IEC 61228 standard entitled “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method” (Ref. 5). At their meeting in 2003, IEC TC 61, MT 16 and IEC SC 34A reached a consensus position on lamp testing and classification. This position has now been incorporated into the IEC 60335-2-27, Ed. 5.0 standard (Ref. 6) and the IEC 61228, Ed. 2.0 standard (Ref. 5).

In October 2003, FDA presented six amendments to TEPRSSC and all were approved with modifications to two of the proposals. These six amendments, along with others, are being presented in this proposed rule and are outlined in section II.

In addition, FDA has informed radiological health representatives from the states of our intentions to amend the Sunlamp Products Performance Standard through semi-annual meetings with the state Conference of Radiation Control Program Directors. See Web site at http://www.crcpd.org/.

FDA is concerned about the safety risks from UV radiation. Therefore, FDA is updating our requirements for sunlamp products—which allow for indoor exposure to UV radiation.

FDA is undertaking three initiatives to address the risks associated with sunlamp products. First, in a final reclassification order that issued June 2, 2014 (79 FR 31205 at 31213), FDA reclassified sunlamp products and UV lamps intended for use in sunlamp products from class I to class II, and established special controls and premarket notification (510(k)) requirements under the medical device authorities of the FD&C Act. The special controls include performance testing and labeling requirements, including a warning that sunlamp products are not to be used on persons under the age of 18 years.

Second, and simultaneously with this proposed rule, FDA is proposing device restrictions under section 520(e) of the FD&C Act (21 U.S.C. 360j(e)), which authorizes FDA to issue regulations imposing restrictions on the sale, distribution or use of a device, if, because of its potentiality for harmful effects or the collateral measures necessary to its use, FDA determines that absent such restrictions, there cannot be a reasonable assurance of its safety and effectiveness. As explained elsewhere in this issue of the Federal Register, the proposed device restrictions would require that:

1. Tanning facility operators permit use of sunlamp products only if the prospective user is age 18 or older;

2. Tanning facility operators, upon request by the user or prospective user, provide a copy of the sunlamp product user manual or name and address of the manufacturer or distributor from who a user manual may be obtained;

3. 510(k) holders assure that a user manual accompanies each sunlamp product and, upon request, provide a copy of the user manual to any tanning facility operator, user or prospective user; and

4. Tanning facility operators obtain each prospective user's signature on a risk acknowledgement certification before use that states that they have been informed of the risks to health that may result from use of these devices.

These device restrictions would primarily apply to tanning facility operators, and to a lesser extent, device manufacturers and distributors. FDA would not consider people who use their own tanning beds (home users) to be tanning facility operators.

Finally, in this action, FDA is proposing amendments to the sunlamp products and UV lamps performance standard at § 1040.20 (21 CFR 1040.20) (last updated in 1985), which includes technical and labeling requirements issued under the radiological health provisions of the FD&C Act. FDA is taking this action to reflect current scientific knowledge related to sunlamp product use, harmonize it more closely with IEC International Standard 60335-2-27, Ed. 5.0: 2009-12, and strengthen the warning statement required by § 1040.20(d)(1)(i) in accordance with the results of the study FDA conducted under section 230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85).

This preamble will focus on the proposed changes to § 1002.1 and § 1040.20, which include:

• Requiring that UV lamp manufacturers follow the same reporting requirements as sunlamp product manufacturers,

• Requiring that protective eyewear manufacturers maintain distribution records and test records relating to the UV and visible transmittance of the eyewear as well as requiring the submission of annual reports, supplemental reports, and product reports to FDA,

• Changing the content, format, and location of the required warning statement to make it more effective at communicating the risks of indoor tanning to consumers,

• Replacing the current limit on the ratio of UVC to UVB irradiance with an absolute limit on UVC irradiance,

• Limiting the maximum timer interval to one that would not exceed a maximum dose of 500 J/m2, weighted with the CIE Reference Action Spectrum for Erythema (1999),

• Adopting the IEC “equivalency code” system for labeling and measuring the strength of replacement lamps to prevent original lamps being replaced with more powerful lamps, which can lead to sunburn,

• Changing the current subjective requirement regarding the visible transmittance of protective eyewear to an objective, quantitative requirement, adopted from the IEC standard,

• Adding a cap on the amount of visible transmittance allowed through the protective eyewear, to protect the users' retina from intense visible light,

• Updating the guidelines for the required manufacturer-recommended exposure schedule, by requiring conformity to the IEC standard, which is based on current science,

• Requiring that a reproduction of the warning label be provided in all catalogs, specification sheets, brochures, and consumer-directed Web pages on which sunlamp products are offered for sale, and

• Requiring that persons involved in significant modification of sunlamp products re-certify the product just as the manufacturer of a new product would. This requirement currently exists in the FDA Laser Standard (21 CFR 1040.10(i)).

FDA proposes to amend the requirements of part 1002 as specified in table 1 to require that manufacturers of UV lamps intended to be used in sunlamp products are subject to the same record and reporting requirements as manufacturers of sunlamp products. When table 1 was first codified, it was common for the manufacturers of UV lamps to be the same entity that manufactured the sunlamp product. Today, the market has changed and there are some manufacturers that manufacture only UV lamps. FDA wants to ensure that all test data necessary to ensure compliance with § 1040.20 are collected and maintained. Currently, manufacturers of UV lamps are required to submit only product reports. Under proposed § 1002.1, manufacturers of UV lamps would also be required to submit supplemental reports and annual reports and to maintain test records and distribution records. In addition, manufacturers of protective eyewear would also need to maintain distribution records as well as test records demonstrating that the eyewear complies with applicable UV and visible transmittance requirements. Proposed § 1002.1 would also require that manufacturers of protective eyewear submit annual reports, supplemental reports, and product reports to FDA.

FDA proposes to incorporate certain elements of the IEC International Standard 60335-2-27, Ed. 5.0: 2009-12 entitled “Household and Similar Electrical Appliances—Safety—Part 2-27: Particular Requirements for Appliances for Skin Exposure to Ultraviolet and Infrared Radiation,” by reference (Ref. 6). See proposed § 1040.20(a)(2). A similar approach has been used successfully with the FDA standard for laser products, § 1040.10, see FDA Guidance, “Laser Products—Conformance With IEC 60825-1 and IEC 60601-2-22” (Ref. 7), and FDA has proposed to incorporate by reference several provisions of IEC 60825-1, Ed. 2, into the laser products performance standard (78 FR 37723). Harmonizing the FDA standard with the current IEC standard would bring it up to date with current science and better protect consumers from the risks posed by these devices. FDA has representation on the IEC committee and has had significant influence on changes made to the IEC standard over the past decade. Working with this committee, which includes representatives from industry, government, and the medical community, has provided FDA with useful expertise and perspectives to which it may not otherwise have access.

Harmonization would have benefits for sunlamp product manufacturers as well. Currently, many firms producing sunlamp products for sale within the United States and abroad have to follow both IEC and FDA standards. Aligning these standards would mean that such firms would need to comply with a single set of rules instead of two different ones, at least for the particular clauses which are being adopted and incorporated by reference.

“Protective goggles” would be added to the definition of “protective eyewear” in proposed § 1040.20(b) since this is the synonymous term used in the IEC standard.

The definition of “sunlamp product” would be amended to make clear that tanning beds and tanning booths are included within this term.

We propose adding a definition for “tanning course.” This term is used in Annex DD of IEC 60335-2-27, Ed. 5.0, to aid the manufacturer in the development of its exposure schedule. In the context of exposure schedules, “tanning course” means the period of time over which a tan is developed, starting with the first short exposure and building up to longer exposures over time, usually requiring a period of 3 to 4 weeks. In an effort to ensure that a useful recommendation is provided to the user about maximum annual exposure, this concept is utilized in the exposure schedule requirements at proposed § 1040.20(d)(1)(iv) and the example exposure schedule provided therein. FDA is uncertain how users might best keep track of their exposure over many weeks and months, and is particularly interested in comments on the best approach for informing users about limiting their annual exposure.

Proposed § 1040.20(c)(1) would set the irradiance limit for UVC radiation (200-290 nm) at 0.03 Watts/meter2 (W/m2) at the shortest recommended exposure distance from the sunlamp product. This limit is the same as the one in the previous version of IEC 60335-2-27 (Ed. 4.2: 2007-04). This requirement would replace the current limit on the ratio of irradiance in the 200 to 260 nm wavelength range to the irradiance in the 260 to 320 nm wavelength range (see § 1040.20(c)(1)). One of the comments received in response to the 1999 ANPRM recommended that the current ratio limit in § 1040.20(c)(1) be dropped since it is no longer necessary, considering current low-pressure lamp technology, and because a limit on the UVC/UVB ratio provides less safety than an absolute limit on the UVC emissions from a sunlamp product. FDA agrees with this comment. An absolute limit on UVC (200-290 nm) irradiance would provide greater assurance of user safety because a ratio permits higher doses of UVC (as long as they correspond to higher doses in the 260 to 320 nm range). UVC, which is not present in sunlight that reaches the Earth's surface, is potentially harmful to users while less effective for tanning than UVA or UVB. FDA has chosen not to adopt the limit for UVC radiation in Ed. 5.0 of IEC 60335-2-27 because this limit is 10 times lower than the limit in Ed. 4.2 and FDA believes that it would be difficult for some manufacturers to measure irradiance at this level. FDA is particularly interested in comments on this proposal.

FDA proposes to change § 1040.20(c)(2) by adding a dose-based limit similar to the one in FDA's 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3) to the maximum timer interval requirement in paragraph (c)(2)(ii). FDA also proposes to remove paragraph (v) from § 1040.20(c)(2).

Proposed § 1040.20(c)(2)(ii) would incorporate by reference the action spectrum used in figure 103 of IEC 60335-2-27, Ed. 5.0 for calculating the effective dose that defines the maximum timer interval. This method uses the internationally-accepted CIE Reference Action Spectrum for Erythema (Ref. 8) instead of the CIE LYTLE action spectrum that was defined in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3). Since 1986, the CIE Action Spectrum for Erythema has been verified and accepted by research laboratories across the globe. As a result, it is used worldwide in the calculation of the UV Index.

The 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule also recommends the use of the Parrish 1982 melanogenesis action spectrum, in addition to the CIE LYTLE erythema action spectrum, as a secondary means of calculating the maximum timer interval. As it has been found that the two action spectra are highly correlated, this calculation does not provide independent characterization data and the requirement is redundant. Therefore, proposed § 1040.20(c)(2)(ii) would not require a second calculation of the maximum timer interval.

Proposed § 1040.20(c)(2)(ii) would limit the maximum timer interval to one that would result in a biologically-effective (also referred to as erythemal-effective) dose that would not exceed 500 J/m2, which is approximately equivalent to the 624 J/m2 value (weighted with the CIE LYTLE action spectrum) that was specified in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3). Although the FDA would like to harmonize its standard as much as possible with the IEC standard, consumer safety is our main concern. Based on spectral irradiance data submitted to the Agency and on data presented at the 2004 Commission Internationale de l'Eclairage (CIE) Symposium on “Light and Health: Non-visual effects” (Ref. 10), FDA has determined that a dose of 500 J/m2 (weighted with the CIE erythemal action spectrum) provides a biologically-equivalent dose that is more closely matched to the current 624 J/m2 value than does the IEC dose limit of 600 J/m2. FDA invites comment on this proposal.

Proposed § 1040.20(c)(3) would add a requirement that the control enabling manual termination of radiation emission (sometimes referred to as the “panic button” or “emergency stop”) be easily accessible and readily identifiable to the user. This would ensure that users can easily turn the sunlamp product off for any reason.

Proposed § 1040.20(c)(4)(ii) would expand application of the performance requirements to all protective eyewear intended to be used with sunlamp products, whether sold together with a sunlamp product or sold separately. As we have previously explained, UV wavelengths can cause serious eye damage, and exposure to the shorter wavelength region of the UV spectrum is especially dangerous. (See 42 FR 65189 at 65191, December 30, 1977.) Short-term risks include photokeratitis, which is very painful and causes temporary loss of vision, and there is also a risk of retinal damage from short-term or long-term exposure, which could cause blind spots to form in the retina. Repeated, long-term UV exposure increases the risk of cataracts, and there is evidence of an association between UV exposure and ocular melanoma (Ref. 11).

The spectral transmittance requirements for protective eyewear are necessary to protect users of sunlamp products from these risks, which directly result from the UV radiation emitted by the sunlamp product. Users of sunlamp products, especially those who tan in tanning facilities, often use protective eyewear manufactured by an entity other than the manufacturer of the sunlamp product. Use of sunlamp products with eyewear that does not meet these requirements would increase the risk posed by the radiation emitted by the sunlamp product and undermine the protection provided by the performance standard. Therefore it is necessary to apply the standard to all protective eyewear intended to be used with sunlamp products.

The proposal would also modify the protective eyewear transmittance requirements of § 1040.20(c)(4)(ii) to better ensure user safety and achieve harmony with the IEC standard. (See clause 32.102 of IEC 60335-2-27, Ed. 5.0.) The requirements for spectral transmittance in the UV range of 200-400 nm would remain the same as in the current FDA standard. The proposed rule would adopt the limit of 5 percent on the visible transmittance in the range of 400-550 nm from clause 32.102 of the IEC standard. This requirement would provide additional safety to protect the retina from intense visible light. Currently, there is no such requirement included in the FDA standard. The proposed rule would abandon the current requirement that spectral transmittance shall be sufficient over the wavelength range greater than 400 nm to provide visibility to the user, and instead adopt the lower limit of 1 percent on luminous transmission from clause 32.102 of the IEC standard. Replacing the subjective standard with an objective one would make compliance easier to verify and improve uniformity and consistency.

Proposed § 1040.20(d)(1)(i) would modify the warning statement required to appear on the label of all sunlamp products. FDA believes that the current warning statement is too long, not user-friendly, and that its content and format could be improved to more effectively communicate the risks of indoor tanning to users. As discussed in section I, FDA has been considering updating the required warning since 1999. In 2007, Congress required FDA to conduct consumer focus group testing to evaluate the adequacy of sunlamp product warning labels in conveying certain risk information to consumers, including the risk of skin cancer. (See section 230 of the Food and Drug Administration Amendments Act of 2007, Pub. L. 110-85.) Based on its analysis of the consumer testing, FDA concluded that the current warning statement could be made more effective by changing its required language, formatting, and location. See the FDA Report to Congress entitled “Labeling Information on the Relationship Between the Use of Indoor Tanning Devices and Development of Skin Cancer or Other Skin Damage” (Ref. 12).

FDA would like to harmonize its standard as much as possible with the IEC 60335-2-27 Ed. 5.0 standard. However, based on the results of the focus group testing, we believe it is appropriate for some differences to remain between the FDA warning statement and the IEC warning statement, especially since the IEC warning statement provides only the general substance to be conveyed (since it is intended for use in multiple languages) and does not provide formatting specifications. FDA believes that the proposed warning statement would most effectively convey the risks of indoor tanning to users. Specifically, the label of each sunlamp product would have to contain a warning statement with the following language and format:

UV can cause:

Wear FDA-compliant protective eyewear to prevent eye damage, such as burns or cataracts.

Follow the recommended exposure schedule to avoid severe skin burns.

Talk to your doctor or pharmacist before tanning if you use medicines and/or cosmetics. Some of these products can make you more sensitive to skin and eye damage from UV.”

Currently, § 1040.20(d)(1)(iv) requires sunlamp product labels to include a recommended exposure schedule containing certain information. FDA proposes to add a requirement that the exposure schedule be developed in accordance with the specific parameters in IEC 60335-2-27, Ed. 5.0, Annex DD, which would be incorporated by reference. The proposed rule provides an example of a recommended exposure schedule that would meet the guidelines/parameters in IEC 60335-2-27, Ed. 5.0, Annex DD. See proposed § 1040.20(d)(1)(iv). These parameters are different from those provided in the 1986 FDA Policy Letter on Maximum Timer Interval and Exposure Schedule (Ref. 3), and are based on current science, including recent human research conducted at FDA. This requirement is aimed at reducing the cumulative UV dose to sunlamp product users and attaining closer harmonization of FDA and the IEC standard.

Proposed § 1040.20(d)(1)(iv) would also require a warning to appear either directly above or below the exposure schedule stating “Skin Type I individuals (always burns, never tans) should never use sunlamp products.” This warning is based on years of published research showing that Skin Type I individuals sunburn easily and cannot tan and are therefore at the greatest risk for skin cancer. By “Skin Type” we are referring to the historical Fitzpatrick skin typing system (Ref. 13) developed in 1975 by dermatologist Thomas Fitzpatrick to predict skin reactivity in phototherapy. Under this categorization scheme, Skin Type I is the fairest and most sensitive while Skin Type VI is the darkest and least sensitive to UV radiation. The Skin Types that are most likely to tan through the use of sunlamp products are Skin Types II through IV. It has been shown (Ref. 14) that Skin Types III and IV can attain a tan with UV doses that are similar to what is needed for Skin Type II. Thus, the same dose can be used to develop and maintain a tan for all three Skin Types. This was confirmed in clinical studies performed at FDA (Ref. 15). This is a change from the approach of the 1986 Policy Letter, which called for exposure schedules to be differentiated by Skin Type.

The proposed rule would also improve user safety by adopting the IEC's “equivalency code” system for ensuring compatibility between sunlamp products (e.g., tanning beds and booths) and the UV lamps (sometimes referred to as light bulbs) that are used in them. Proposed § 1040.20(d)(1)(vi) would require the label of all sunlamp products to indicate the equivalency code range of the UV lamp to be used in the sunlamp product. The equivalency code range would have to be determined in accordance with clause 22.111 and Annex CC of IEC 60335-2-27, Ed. 5.0, which would be incorporated by reference. Proposed § 1040.20(d)(2)(ii) would require the label of each UV lamp to indicate its UV lamp equivalency code, as defined in Annex CC of IEC 60335-2-27, Ed. 5.0. In determining the “UV code” component of the UV lamp equivalency code, output would have to be measured in accordance with IEC 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps used for Tanning—Measurement and Specification Method,” (Ref. 5) which would be incorporated by reference.

FDA believes the adoption of the IEC's absolute rating system for replacement lamps would eliminate confusion regarding proper lamp replacement, facilitate the enforcement of lamp compatibility requirements, and improve the safety of sunlamp products. Currently, FDA relies on a relative system in which the lamp manufacturer has to provide to FDA and to users a list of lamps with which the manufacturer's lamp is compatible. (See §§ 1002.10 and 1040.20(e)(2)(iii).) As new lamp manufacturers and new lamp models enter the marketplace, while other manufacturers abandon old models of lamps or leave the marketplace, it is increasingly cumbersome to keep track of which lamps are compatible with the lamps originally provided with the sunlamp product. This can cause confusion for tanning facility owners, FDA, and State or local inspectors. When incorrect lamps are used as replacements, the erythema-effective intensity may be greater, resulting in burns. Therefore, FDA has decided that an absolute rating system is needed, which would require that a code be printed on the lamp to indicate its erythema-effective output, and a code range be printed on the sunlamp product, to indicate which lamps to use with it. Another advantage of adopting the provisions in both of these IEC standards is that they provide detailed measurement specifications, which would ensure consistency among manufacturers.

Proposed § 1040.20(d)(3) would retain the requirement of the current FDA standard that the required label information must be legible and readily accessible to view by a sunlamp product user immediately prior to use. FDA provided details regarding compliance with this requirement in its June 25, 1985, policy letter entitled “Policy on Warning Label Required on Sunlamp Products” (Ref. 2). Proposed § 1040.20(d)(3)(i) would incorporate similar specifications into the rule regarding the location, spacing, and font of the required warning statement. The proposal specifies that the warning statement would have to be readily accessible to view whether the tanning bed canopy or tanning booth door is open or closed when the user approaches, which may necessitate that it appear in more than one location on the sunlamp product. FDA believes that these label specifications would ensure that users see the required warning prior to use, and would result in a more comprehensive and effective standard.

Proposed § 1040.20(d)(3)(ii) specifies that required UV lamp information would have to appear on the packaging of the lamp in addition to being permanently affixed or inscribed on the lamp itself. This would ensure that anyone replacing a UV lamp would be aware of the lamp equivalency code and required warnings before and after purchase.

We propose revising § 1040.20(d)(3)(iv) to achieve consistency with the requirement in the device labeling regulations at 21 CFR 801.15(c)(1) that all words, statements, and other information required by or under authority of the FD&C Act to appear on the label or labeling of a device must appear in the English language (or a foreign language for articles distributed solely in Puerto Rico or in a Territory where the predominant language is not English). Since the labeling of UV lamps must comply with the labeling requirements of part 801 and § 1040.20, we propose to remove the language in § 1040.20(d)(3)(iv) that permits the manufacturer to express the manufacturer's name and month and year of manufacture as code or symbols. FDA is not aware of any request to use symbols or codes for this purpose in the past.

The proposal would remove § 1040.20(e)(1)(iv) since the recommended exposure schedule no longer needs to be differentiated by skin type and would be required to be prominently displayed at the beginning of the users' instructions under proposed § 1040.20(e)(1)(i).

Proposed § 1040.20(e)(1)(v) would add a requirement for the provision of instructions and warnings regarding assembly, operation, and maintenance, which is modeled on the proposed FDA Performance Standard for Laser Products (78 FR 37723). This would better protect individuals who assemble, test, and maintain sunlamp products.

Proposed § 1040.20(e)(3) would add a requirement for the provision of the required warning statement in all catalogs, specification sheets, and descriptive brochures intended for consumers in which sunlamp products are offered for sale, and on all consumer-directed Web pages on which sunlamp products are offered for sale. This requirement would ensure that consumers are fully informed of the risks presented by sunlamp products at the time they consider purchasing it.

Proposed § 1040.20(f) would add a requirement that the performance requirements for the measuring instrument in clause 32.101 of IEC 60335-2-27 Ed. 5.0 would apply.

Proposed § 1040.20(g) is also modeled after the proposed FDA Performance Standard for Laser Products (78 FR 37723). FDA believes the addition of these requirements, which have been used successfully over the past 2 decades for laser products, would improve safety by ensuring that modifications that affect performance would be held to the same standards as original manufacturing.

Section 532 of the FD&C Act (21 U.S.C. 360ii) authorizes FDA to establish and administer an electronic product radiation control program to protect the public health and safety. Section 534 of the FD&C Act gives FDA authority to issue regulations establishing performance standards for electronic products to control their emission of radiation. These standards may include requirements for product testing and radiation measurement, the attachment of warning signs and labels, and the provision of instructions for product installation, operation, and use. Section 1003(b)(2)(E) of the FD&C Act (21 U.S.C. 393(b)(2)(E)) requires FDA to ensure that public health and safety are protected from electronic product radiation. In addition, section 701(a) of the FD&C Act (21 U.S.C. 371(a)) authorizes the Agency to issue regulations for the efficient enforcement of the FD&C Act.

Section 230 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) directed FDA to determine whether changes to the warning statement would more effectively communicate the risks of indoor tanning, such as skin cancer, and to submit a report that includes an explanation of the measures being implemented to significantly reduce the risks associated with indoor tanning devices. As explained in section II, based on consumer testing, FDA determined that the proposed warning statement would better communicate the risks of indoor tanning to consumers, and is proposing these amendments to the sunlamp products performance standard to significantly reduce the risks associated with these products.

FDA proposes that any final rule issued based on this proposal become effective 1 year after the date of publication of the final rule in the Federal Register.

The Agency has determined under 21 CFR 25.34(c) that this proposed action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environment impact statement is required.

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

The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. We do not believe this proposed rule would result in a significant impact on a substantial number of small entities, but the impacts are uncertain so we are explicitly seeking comment on the impacts.

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

The proposed rule would affect several aspects of the performance standards to reduce risks associated with use. The costs are summarized in table 1. Estimated one-time costs are $20,917 to $113,240 and annual costs are $4,686 to $7,230. The present discounted costs are $57,181 to $151,390 at 7 percent and $61,498 to $165,883 at 3 percent. Annualized at 7 percent over 10 years, total costs are $8,141 to $21,498. At 3 percent, annualized total costs are $7,867 to $19,447.

The primary benefit of the proposed rule would be from reduced injuries, including sunburn, photokeratitis, skin cancer, cataracts and ocular melanoma and from reduced exposure to UV radiation. We are unable to quantify the benefits, but demonstrate that they satisfy breakeven tests using very conservative assumptions. The benefits of this proposed rule would justify the costs.

The full assessment of the economic analysis is available in Docket FDA-1998-N-0880 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 16).

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive Order requires Agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision at section 542 of the FD&C Act (21 U.S.C. 360ss) that preempts the States from establishing, or continuing in effect, any standard with respect to an electronic product which is applicable to the same aspect of product performance as a Federal standard prescribed under section 534 of the FD&C Act and which is not identical to the Federal standard. If this proposed rule is made final, the final rule would prescribe a Federal standard under section 534 of the FD&C Act. However, section 542 of the FD&C Act does not “prevent the Federal Government or the government of any State or political subdivision thereof from establishing a requirement with respect to emission of radiation from electronic products procured for its own use if such requirement imposes a more restrictive standard than that required to comply with the otherwise applicable Federal standard.” (Section 542 of the FD&C Act.)

This proposed rule contains information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in the paragraphs that follow with an estimate of the annual reporting, recordkeeping, and third-party disclosure burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.

FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Title: Sunlamp Products; Proposed Amendment to § 1002.1 (Record and Reporting Requirements) and § 1040.20 (Performance Standard).

Description: The Safe Medical Devices Act of 1990 (Pub. L. 101-629) transferred the provisions of the Radiation Control for Health and Safety Act of 1968 (Pub. L. 90-602) from Title III of the Public Health Service Act (42 U.S.C. 201 et seq.) to Chapter V, subchapter C of the FD&C Act (21 U.S.C. 301 et seq.). Under the FD&C Act, FDA administers an electronic product radiation control program to protect the public health and safety. FDA also develops and administers radiation safety performance standards for electronic products, including sunlamp products.

Current § 1002.1 requires that sunlamp product manufacturers submit product reports, supplemental reports, and annual reports and requires that test records and distribution records are maintained, used for summary data submitted in the annual report, and made available upon request. In addition, current § 1002.1 requires UV lamp manufacturers to submit product reports. Proposed § 1002.1 would require that manufacturers of UV lamps also submit supplemental reports and annual reports and maintain test records and distribution records.

Proposed § 1002.1 would also require that manufacturers of protective eyewear maintain test records and distribution records as well as submit annual reports, supplemental reports, and product reports. The eyewear must meet certain transmittance limits in the UV and visible wavelength range. Both manufacturers of sunlamp products that include eyewear with their products and manufacturers of protective eyewear that is sold separately would be responsible for maintaining records of the results yielded by the testing and reporting these results to FDA. (See § 1002.1.) There are no operating and maintenance costs associated with testing the eyewear because this requirement reflects current market practices.

Proposed § 1040.20(d)(2)(ii) would require that the UV lamp labeling include a replacement lamp code instead of a list of compatible replacement lamps. Although the single UV lamp manufacturer in the United States is already required to conduct spectral irradiance testing of lamps in order to demonstrate compatibility with other model lamps (whether made by that company or other manufacturers), proposed § 1040.20(d)(2)(ii) would require testing in accordance with test methods as specified in IEC 61228, Ed. 2.0, “Fluorescent Ultraviolet Lamps Used for Tanning—Measurement and Specification Method.” The spectral irradiance data obtained is used to calculate the UV code that would be required to be printed on the lamp by proposed § 1040.20(d)(2)(ii). Manufacturers would be responsible for maintaining and reporting records of the results yielded by the testing as well as imprinting the lamp with the replacement lamp code.

Proposed § 1040.20(d)(2)(iii) would require that each UV lamp have a label containing the model identification of the lamp, if applicable. Manufacturers would be responsible for printing the model number on the lamp itself.

Proposed § 1040.20(d)(3)(iii) would permit the manufacturer of the sunlamp product or UV lamp to submit a request to the Director, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health for an approval of alternate labeling if the size, configuration, design, or function of the sunlamp product or UV lamp would preclude compliance with the requirements for any required label or would render the required wording of such label inappropriate or ineffective. In these circumstances, manufacturers would be responsible for reporting the request to FDA. The operating and maintenance costs associated with this provision are based on correspondence costs (postage) for non-email communications.

Proposed § 1040.20(d)(3)(iv) would permit manufacturers of UV lamps to permanently affix or inscribe the tags or labels required by §§ 1010.2(b) and 1010.3(a) on the lamp packaging associated with the UV lamps, rather than the UV lamps themselves. The third party disclosure burden of this provision would be the time it takes to inscribe the label or tag on the UV lamp packaging.

Proposed § 1040.20(e)(1)(v) would require instructions for sunlamp “assembly, operation, and maintenance,” and would include a schedule of maintenance. This information would also protect those maintaining and assembling sunlamp products from inadvertent exposure to UV radiation by providing adequate instructions to avoid UV exposure during assembly or maintenance. We presume that the maintenance schedules would be developed from known information about how to properly maintain these devices. The third party disclosure burden of this provision would be the time spent bringing this known information into a user-friendly format and disclosing it to users. We also assume that this information would be identical for all units of a given model of sunlamp products.

Proposed § 1040.20(g) would require that those who change the function or performance characteristics of a sunlamp are manufacturers and would need to recertify and re-identify the device. This requirement applies only if the modification affects any aspect of the product's performance or intended function(s) for which § 1040.20 has an applicable requirement. We believe some sunlamp owners (e.g., tanning facility owners) view such modifications as a less expensive alternative to purchasing a new sunlamp product. We believe some owners, otherwise inclined to alter their sunlamp's performance characteristics, would be deterred from doing so by our proposal because recertification would cost a tanning facility owner more than $30,000 in operating and maintenance costs since tanning facility owners do not typically have the equipment necessary to recertify sunlamp products. However, if a tanning facility owner chooses to recertify the sunlamp product, documentation must be submitted to FDA.

Description of Respondents: Respondents for these information collections are manufacturers of sunlamp products and UV lamps intended for use in sunlamp products, and manufacturers of protective eyewear that is intended to be used with sunlamp products.

FDA estimates the burden of this collection of information as follows:

You may submit or retrieve comments online through the Federal eRulemaking portal at: http://www.regulations.gov. The Web site is available 24 hours each day, 365 days each year. Please follow the instructions. Electronic submission and retrieval help and guidelines are available under the help section of the Web site. An electronic copy of this document may also be downloaded from the Office of the Federal Register's home page at: http://www.archives.gov and the Government Printing Office's Web page at: http://www.access.thefederalregister.org/nara. Anyone is able to search the electronic form of all comments in any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, or labor union). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70, Pages 19477-78), or you may visit http://DocketsInfo.dot.gov.

The FHWA is interested in planning for future editions of the MUTCD 1 that will reflect the growing number and application of traffic control devices, changes in technology not only for traffic control devices, but for viewing content in the MUTCD, and developing a structure for the MUTCD that is efficient and easy to use. The FHWA initiated the public comment process by publishing an RFC at 78 FR 2347 (Docket ID: FHWA-2012-0118) on January 11, 2013, that included two options for restructuring the MUTCD and several questions regarding content and public use of the MUTCD. The FHWA's response to the comments, issued June 17, 2013 at 78 FR 36132 (Docket ID: FHWA-2012-0118-0187), indicated that over one half of the commenters recommended postponing any action to restructure the manual pending results from the ongoing National Cooperative Highway Research Program (NCHRP) strategic planning effort.2 That effort is now complete.

The purpose of this notice is to solicit comments from users of the MUTCD about the direction of future editions of the MUTCD. This notice includes a set of specific questions for which FHWA requests comments. Comments and input may be offered on any part of this notification.

The MUTCD is incorporated by reference within Federal regulations at 23 CFR part 655, approved by FHWA, and recognized as the national standard for traffic control devices used on all public roads. The MUTCD was incorporated by reference into the Code of Federal Regulations beginning with the publication of the 1971 edition. There have been 10 editions of the MUTCD, beginning with the first edition in 1935. The current MUTCD is the 2009 Edition, incorporating Revisions 1 and 2, dated May 2012 and is available to the public at http://mutcd.fhwa.dot.gov/kno_2009r1r2.htm.

Over the last several years, the transportation community has expressed concern over several issues related to the MUTCD: (1) Size, (2) complexity in finding information, (3) amount/type of information in the MUTCD, and (4) timeframe required for new traffic control devices or applications to be incorporated. To begin to address these issues, FHWA published an RFC at 78 FR 2347 (Docket ID: FHWA-2012-0118) on January 11, 2013, requesting comment on a potential restructuring of the MUTCD into two documents: The MUTCD and an Applications Supplement (herein referred to as “Restructuring RFC”). The FHWA's response to the comments, issued June 17, 2013, at 78 FR 36132 (Docket ID: FHWA-2012-0118-0187), indicated that given the lack of support from the MUTCD user community, FHWA would not proceed with restructuring the MUTCD into two documents. As discussed in the response to comments, more than 90 percent of the docket letters were either against splitting the MUTCD into two separate documents (approximately 56 percent of responses), or recommended postponing any action to split the manual pending results from the ongoing NCHRP strategic planning effort (approximately 34 percent of responses), which was expected to be available in January 2014. The strategic planning effort was to address many issues that would impact future MUTCD content and structure, including consideration of an MUTCD that would consist of more than one volume. In addition to requesting that FHWA wait for the results of the NCHRP strategic planning effort, many State and local agencies, associations, and consultants suggested that if a decision were to be made to restructure the MUTCD in any significant way, it would be critical for FHWA to partner with stakeholders to develop content for a restructured MUTCD.

The NCHRP task to which the commenters were referring, NCHRP 20-07/Task 323, is now complete. The objective of the task was to develop a long-range Vision and Strategic Plan for the MUTCD. The plan was delivered to the American Association of State Highway and Transportation Officials' Highway Subcommittee on Traffic Engineering, which approved it by ballot, and then to the National Committee on Uniform Traffic Control Devices (NCUTCD) where that organization adopted the plan (herein referred to as the Vision and Strategic Plan) at its January 2014 meeting.3 The Vision and Strategic Plan contains a discussion of opinions, challenges, needs and questions followed by a presentation of a vision for the MUTCD of the mid-2030s. To achieve that vision, the document includes a strategic plan for transitioning from the current edition to future editions through a series of incremental changes. With the NCHRP effort now complete, and in response to comments from the Restructuring RFC, FHWA believes it is now appropriate for a wider audience of MUTCD users to provide comments to FHWA on the direction of future editions of the MUTCD. It is important to note that FHWA is not seeking comments on the Vision and Strategic Plan document itself. Nor is FHWA seeking comment on any specific proposals for change.

Concurrent with this effort, FHWA is preparing a Notice of Proposed Amendments (NPA) for the next edition of the MUTCD. The publication date of the NPA is not yet known. Depending on the nature and extent of comments submitted for this RFC, FHWA may incorporate some of the suggestions in the next edition of the MUTCD. More importantly, FHWA is looking to begin planning for MUTCD editions further into the future with the comments submitted for this RFC.

As discussed above, the public may submit comments online through the Federal eRulemaking portal at: http://www.regulations.gov. In an effort to streamline the process for organizing and reviewing docket comments, the public is invited to submit comments in a spreadsheet that has been specifically developed for this notice. The spreadsheet is available for review and download on http://www.regulations.gov under the docket number listed in the heading of this document. Commenters who wish to use the spreadsheet for their comments are encouraged to download and fill in the spreadsheet, then upload the completed file as indicated in comment instructions. Alternatively, commenters may submit their comments in the comment box and/or via uploading a different file.

Over the years, the MUTCD has expanded in size, due in part to the belief that the MUTCD needs to contain information that is appropriate for all its users. The size and complexity of the MUTCD have significantly increased primarily because of an expansion of the number of devices included in the MUTCD and the desire to provide more specifics in conveying the intent of the language in order to avoid uncertainty. The first edition of the MUTCD, published in 1935, had 166 pages, whereas the current MUTCD contains 820 pages of technical provisions. As discussed in the Restructuring RFC in 2012, FHWA is interested in examining ways to simplify and streamline the MUTCD in a manner that is most user-friendly, while maintaining the appropriate amount of information.

The MUTCD is used by a wide audience, from State, local, and consulting traffic engineers, to traffic control device technicians, and to some extent, the public. The Vision and Strategic Plan suggests that the size and the complexity of the MUTCD may be reduced by targeting the MUTCD to a more specific audience or organizing it to provide information for different types of users. While FHWA understands that the MUTCD has gained a wide audience, writing or organizing the MUTCD accordingly may be cumbersome and may not have the intended result of simplifying the MUTCD. The MUTCD is currently designed as an engineering reference manual.

1A. Should MUTCD content continue to be written with a traffic engineer as the intended audience?

As indicated above, FHWA previously issued the Restructuring RFC to identify potential options for simplifying the MUTCD. Comments were not in favor of splitting the MUTCD into two separate documents and many suggested waiting on the results of the Vision and Strategic Plan before determining whether or not the MUTCD should be restructured in a significant way.

In addition to simplifying, FHWA is exploring several of the reorganizing suggestions received from the Restructuring RFC. The current structure of the MUTCD is based on the type of device and the specialized application of devices. The 2009 edition includes Parts 1 through 4 for types of devices and Parts 5 through 9 for specialized applications of devices. This has been the basic structure of the MUTCD since its inception. In the 2000 edition, FHWA added the current headings of content (Standard, Guidance, Option, and Support paragraphs). The headings provide a clear level of mandate associated with specific content. However, this division by level of mandate can create challenges in providing text that reads well and flows together.

In order to provide greater flexibility in the MUTCD, the Vision and Strategic Plan recommends an additional level of mandate that would include two versions of Standard statements rather than one. Both types would be requirements, but one level would relate to uniformity while the other would relate to consistency. The uniformity Standard would require the same action in every case and would not allow for deviation based on site conditions. The consistency Standard would require the same action in every case unless a deviation was warranted to accommodate local conditions. The meanings of Guidance (recommended) and Option (permissible) provisions would remain unchanged. The FHWA believes that this concept is not viable for several reasons. First, it would tend to make the MUTCD more complex rather than less complex. Second, because both conditions would be requirements, it is not likely that any legal distinction could be made between the two. The provisions of the current MUTCD do not preclude the application of engineering considerations.

Coordination within the MUTCD regarding the use of related devices at a single location is often limited. An MUTCD user that is trying to make decisions regarding aspects of traffic control devices used at a specific location might need to reference several different portions of the MUTCD to determine the optimal combination of devices and device features. For example, to review all provisions related to crosswalks, a reader could potentially need to consider Parts 2, 3, 4, 6, 7, 8, and 9, depending on the extent to which the design involves the basic devices of signs, markings, and signals; and specialized applications such as temporary traffic control, school zones, rail grade crossings, and shared-use paths. Cross referencing within the MUTCD is usually provided as appropriate to direct users to related provisions in other Sections or Parts of the MUTCD.

The tendency for future editions of the MUTCD is likely to expand the amount of content, potentially exacerbating the difficulty in using and finding information in the MUTCD. The FHWA is seeking comment to assess options for structuring the MUTCD to make it easier to use. The following are potential options for simplifying and reorganizing the MUTCD:

a. Maintain the current structure and format of the MUTCD.

b. Reorganize the MUTCD content. Potential reorganization structures include:

i. Traffic control devices by application. Parts 2, 3, and 4 in the current MUTCD would be combined to address applications such as urban intersections, rural highways, and collector streets. These applications would address the use of signs, markings, and signals within that context. Parts 5-9 of the current MUTCD currently use this approach. Such a structure would provide most of the content needed for a given application in a consolidated location within the MUTCD.

ii. By level of mandate (e.g., Standard and Guidance). Separating Standard, Guidance, Option, and Support provisions within each section may help MUTCD users find information more easily. For example, more experienced MUTCD users may only need to review specific requirements and would want to review only the Standard and Guidance provisions.

iii. By MUTCD user (e.g., field personnel and engineers). Field personnel typically focus on the field location, installation, and inspection of traffic control devices. Engineers and technicians typically focus on the overall design, operations, and context of a traffic control device in relation to the transportation facilities and other traffic control devices. Consolidating provisions related to user types may simplify the MUTCD for those individuals.

c. Relocate some of the content from the MUTCD into a companion document that has a similar structure as the MUTCD. The companion document would not contain requirements and could be revised without the rulemaking process. This restructuring would take place in a future edition, not the next edition.

i. The restructured MUTCD could include traffic control device standards that do not change such as the meaning, appearance, and other key standards.

ii. The companion document could include traffic control device guidelines that relate to selection, location, operation, and maintenance of devices. The companion document would need to be developed through a consensus-building process that involves appropriate stakeholders with expertise in the use of traffic control devices. The companion document could be revised more frequently than the MUTCD, because it would not be subject to rulemaking.

2A. In future editions, should FHWA strive to reduce the amount of explanatory language included in the MUTCD?

2B. If so, what types of explanatory language should be removed from the MUTCD?

2C. If explanatory/supplementary information is removed, should it be retained in a separate document?

2D. What organizational structure should be considered for future MUTCDs? Potential alternatives include:

a. Current structure.

b. Application information (e.g., urban intersections, rural highways, and collector streets).

c. By type of information (design and applications, installation, maintenance).

d. Other.

2E. If a different format is not appropriate, what potential alternatives/tools would help users more easily find information?

2F. As we move toward more electronic use of the MUTCD through computers, tablets, and handheld devices, what additional electronic formats or tools would be useful?

There have been 10 editions of the MUTCD (1935, 1942, 1948, 1961, 1971, 1978, 1988, 2000, 2003, and 2009). Timing of revisions of individual editions has varied, with most editions having a limited number of revisions between editions.

Changes to the MUTCD are made through the rulemaking process because the manual is regulatory in nature. Major changes to the MUTCD are incorporated and added through the publication of new editions of the manual. Occasionally, there is a need to initiate special rulemakings between editions of the MUTCD to incorporate important content without waiting for the next edition of the MUTCD. These are called “Revisions” and are incorporated into the official MUTCD on FHWA's MUTCD Web site. In between editions or revisions of the MUTCD, new traffic control devices or applications can be approved for use through the official experimentation and interim approval processes, as described in Section 1A.10 of the MUTCD.4 Information regarding these experimentations and interim approvals is also posted on FHWA's MUTCD Web site.

Developing technical content for inclusion in the MUTCD is a deliberative process. Material associated with new traffic control devices is based on laboratory and/or in-service research evaluations that consider the human factors and performance aspects of the device, which can take several years. The results are then used to develop technical provisions related to that device that can then be considered for a rulemaking activity to amend the MUTCD. The rulemaking process involves publishing a proposed revision for public comment, analyzing the public comments submitted to the docket, and then publishing a final rule that addresses the public comments. For a new edition of the MUTCD, this process typically takes approximately 2 years from the publication of the proposed rulemaking document to the final rule. After the final rule, States have up to 2 years to adopt the new MUTCD or their State equivalent. Given this timeline, it would be impractical to publish new editions of the MUTCD with significant new content at intervals less frequent than 6 years. The next edition of the MUTCD is currently targeted for publication in late 2018, representing 9 years between new editions.5

Currently, 18 States adopt the national MUTCD as their standard, without any supplement. Ten States develop their own MUTCD based on the national MUTCD. Twenty-two States and the District of Columbia and Puerto Rico develop supplements to the national MUTCD.

Developing supplements to the national MUTCD and developing State-specific MUTCDs is likely to be costly to the States and introduces a potential for conflicts with the national MUTCD. State agency resources are already provided to review and comment on national MUTCD rulemaking and many State agencies support their staff member participation in the NCUTCD meetings and activities. As a result, FHWA would like to better understand why States develop their own MUTCDs or supplements. The FHWA believes that a better understanding of why States develop their own MUTCDs could better inform the development of future editions of the national MUTCD. It should be noted that FHWA is not discouraging States from developing their own MUTCDs or supplements.

The FHWA is interested in comments related to the timing of new editions of the MUTCD and intermediate revisions of the MUTCD between editions, as well as the information about the development of State MUTCDs and supplements.

3A. If the minimum practical interval between editions is 6 to 8 years, should FHWA promulgate rulemakings to issue one or more revisions that are focused on individual traffic control devices between new editions of the MUTCD?

3B. What about the national MUTCD or State law makes it necessary for some States to develop their own MUTCDs or supplements?

3C. Is there anything in the national MUTCD that could be changed to reduce the burden for States to review, revise, prepare, and adopt their own State MUTCD or supplement?

Revisions to the rulemaking will be reported in future status updates as part of DoD's retrospective plan under Executive Order 13563 completed in August 2011. DoD's full plan can be accessed at: http://www.regulations.gov/#!docketDetail;D=DOD-2011-OS-0036.

10 U.S.C. 2495b prohibits the sale or rental of sexually explicit material on property under DoD jurisdiction. The section also requires DoD to establish the Resale Activities Review Board (the Board) to review material offered for sale or rental on property under DoD jurisdiction and to make recommendations to the Secretary of Defense, in accordance with section 2495b. Any material that is determined to be sexually explicit, as defined by section 2495b, is not offered and if materials are already on store shelves, they are removed.

This proposed rule will cost the DoD approximately $5,500 annually for the life of the rule to manage the Board. It is anticipated that the costs will recur for the life of the proposed rule varying for inflation. 10 U.S.C. 2495b authorizes Board members travel expenses while away from their homes or regular places of business in the performance of services for the Board. DoD implemented section 2495b by issuing DoD Instruction (DoDI) 4105.70, “Prohibition of the Sale or Rental of Sexually Explicit Material on DoD Property” (the Instruction). This instruction is available on the Internet from the DoD Issuances Web site at http://www.dtic.mil/whs/directives. The Instruction established DoD policy that prohibits the sale or rental of sexually explicit material on property under DoD jurisdiction, and no Service member or DoD civilian employee, acting in his or her official capacity, will provide for sale, remuneration, or rental any sexually explicit material to another person. This proposed rule facilitates DoD's compliance with the requirements of 10 U.S.C. 2495b and fulfills the requisite public notification of the DoD process to implement this statutory requirement.

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, distribute 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 proposed rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this proposed rule has been reviewed by the Office of Management and Budget.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) requires agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This proposed rule will not mandate any requirements for State, local, or tribal governments, nor will it affect private sector costs.

The Department of Defense certifies that this proposed rule is not subject to the Regulatory Flexibility Act (5 U.S.C. 601) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

It has been certified that 32 CFR part 235 does not impose reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This proposed rule will not have a substantial effect on State and local governments.

Background: On December 10, 2015, the President signed into law the “Every Student Succeeds Act” (ESSA), amending the Elementary and Secondary Education Act of 1965 (ESEA). The ESSA reauthorizes the ESEA and advances the ESEA's legacy of equity and opportunity by, among other things, requiring States to hold all students to high academic standards that prepare them for success in college and careers. The ESSA also requires that, if students fall behind in meeting these standards, States and local educational agencies (LEAs) implement evidence-based interventions to help them and their schools improve, with a particular focus on the lowest-performing schools, high schools with low graduation rates, and schools in which subgroups of students are underperforming.

The programs included in title I are designed to help disadvantaged children meet high academic standards. These programs include: Improving Basic Programs Operated by State and Local Educational Agencies (part A); State Assessment Grants (part B); Education of Migratory Children (part C); Prevention and Intervention Programs for Children and Youth who are Neglected, Delinquent, or At-Risk (part D); and Flexibility for Equitable Per-Pupil Funding (part E).

The ESSA maintained a number of requirements for, and made a number of significant changes to, the title I programs, including the following:

• Maintaining the requirement for statewide assessments in at least reading/language arts and mathematics in each of grades 3-8 and once in high school; and in science in each of three grade spans (3-5, 6-9, and 10-12), while adding flexibility related to locally selected high school assessments and innovative assessment systems.

• Eliminating the requirement to calculate adequate yearly progress (AYP) and replacing it with a requirement for each State educational agency to develop an accountability system that—

• Includes State-designed, long-term goals and measurements of interim progress for all students and separately for each subgroup of students, on academic achievement and graduation rate, that expect greater progress from groups that are further behind;

• Annually measures, for all students and separately for each subgroup of students, the following indicators: Academic achievement (which, for high schools, may include a measure of student growth, at the State's discretion); for elementary and middle schools, a measure of student growth, if determined appropriate by the State, or another valid and reliable statewide academic indicator; for high schools, the four-year adjusted cohort graduation rate and, at the State's discretion, the extended-year adjusted cohort graduation rate; progress in achieving English language proficiency for English learners; and at least one valid, reliable, comparable, statewide indicator of school quality or student success; and

• Establishes a system of meaningfully differentiating all public schools on an annual basis that is based on all indicators in the State's accountability system and that, with respect to achievement, growth or the other academic indicator for elementary and middle schools, graduation rate, and progress in achieving English language proficiency, affords: Substantial weight to each such indicator; and, in the aggregate, much greater weight than is afforded to the indicator or indicators of school quality or student success.

• Eliminating the requirement to identify schools for improvement, corrective action, or restructuring based on missing AYP over a number of years and instead requiring—

• Identification of, and comprehensive, evidence-based intervention in, the lowest-performing five percent of title I schools, all public high schools with a graduation rate below 67 percent, and public schools in which one or more subgroups of students are performing at a level similar to the performance of the lowest-performing five percent of title I schools and have not improved after receiving targeted interventions for a State-determined number of years; and

• Identification of, and targeted, evidence-based intervention and support in, schools in which any subgroup of students consistently underperforms.

• Maintaining and updating the requirement that State title I plans describe how low-income and minority children enrolled in title I schools are not served at disproportionate rates by ineffective (this term was “unqualified” in the prior version of the ESEA), out-of-field, or inexperienced teachers.

• Expanding the list of elements that must be included in State and district report cards (e.g., adding a requirement to report per-pupil expenditures of Federal, State, and local funds).

• Maintaining the requirement that title I, part A funds be used to supplement, and not supplant, non-Federal funds, but revising the manner in which an LEA must demonstrate compliance with this requirement by requiring an LEA to demonstrate that the methodology it uses to allocate State and local funds to each title I school ensures that the school receives all the State and local funds it would receive in the absence of participation in title I.

This list is not exhaustive. Interested parties should review the statute (available at: https://www.thefederalregister.org/fdsys/pkg/BILLS-114s1177enr/pdf/BILLS-114s1177enr.pdf) for complete information on the amendments made to the ESEA by the ESSA. Please also note that this list is not intended to restrict the topics or issues that commenters may address when providing advice and recommendations in response to this document.

The Secretary invites advice and recommendations from interested parties involved with the implementation and operation of programs under title I concerning topics for which regulations or nonregulatory guidance may be necessary or helpful as States and LEAs transition from NCLB and implement the ESSA. The Secretary specifically invites advice and recommendations from State and local education administrators, parents, teachers and teacher organizations, principals, other school leaders (including charter school leaders), paraprofessionals, members of local boards of education, civil rights and other organizations representing the interests of students (including historically underserved students), representatives of the business community, and other organizations involved with the implementation and operation of title I programs.

Under the ESSA, prior to issuing proposed rules under title I on standards, assessments under section 1111(b)(2), and the requirement under section 1118 that funds be used to supplement, and not supplant, State and local funds, the Department must establish a negotiated rulemaking process.

Negotiated rulemaking can improve the substance of regulations; increase understanding of, and support for, those regulations; encourage affected parties to communicate with each other and share information, knowledge, expertise, and analysis; and discourage expensive and time-consuming litigation concerning the regulations.

The Secretary is considering conducting negotiated rulemaking on academic assessments and the requirement that funds under title I, part A be used to supplement, and not supplant, State and local funds. The Secretary specifically invites comments on these issues.

If the Secretary determines to proceed with negotiated rulemaking, the Secretary will select individuals to participate in this process from among the individuals or groups providing advice and recommendations on title I regulatory issues. The Secretary will publish a separate document in the Federal Register announcing our intent to establish a negotiated rulemaking committee, soliciting nominations of potential negotiators, and providing details about the negotiated rulemaking process.

In addition to inviting specific comments on the issues on which the Secretary is considering conducting negotiated rulemaking, the Secretary invites comments on other regulatory issues concerning provisions under title I, including suggestions that regulations are not needed to resolve a particular issue.

The Secretary requests that each commenter identify his or her interest in education or organizational affiliation, if applicable (e.g., a representative of an association, agency, or school; an individual teacher, student, or parent). The Secretary urges each commenter to be specific regarding his or her recommendations.

During and after the comment period, you may inspect all public comments in response to this document by accessing Regulations.gov. You may also inspect the comments in person at U.S. Department of Education, 400 Maryland Avenue SW., Room 3E306, Washington, DC, between 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays. Please contact the person listed under FOR FURTHER INFORMATION CONTACT.

Regional Meetings: In addition to the invitation to provide written comments in response to this document, the Secretary is offering an opportunity at two regional meetings for the public to provide advice and recommendations concerning issues for which regulations may be helpful to clarify statutory ambiguities or to provide appropriate flexibility.

The regional meetings will be held, from 9:00 a.m. to 5:00 p.m., local time, on the following dates at the following locations:

1. January 11, 2016, at the U.S. Department of Education, 400 Maryland Avenue SW., Barnard Auditorium, Washington, DC.

2. January 19, 2016, at the University of California, Los Angeles (UCLA), Carnesale Commons, 251 Charles E. Young Drive West, Palisades Room, Los Angeles, CA.

Individuals who would like to present comments at the regional meetings must register by sending an email to [email protected] no later than 5:00 p.m. local time on January 5, 2016, for the Washington, DC meeting, and no later than 5:00 p.m. local time on January 12, 2016, for the Los Angeles meeting. The email should include the name of the presenter along with the name of the organization the presenter represents (if any), as well as the regional meeting at which the individual would like to speak. Note that it is likely that each participant will be limited to five minutes.

The Department will notify registrants whether they have been selected to present comments at a regional meeting. An individual may make only one presentation at the regional meetings. If we receive more registrations than we are able to accommodate, the Department reserves the right to reject the registration of an entity or individual that is affiliated with an entity or individual that is already scheduled to present comments, and to select among registrants to ensure that a broad range of entities and individuals is allowed to present.

We will accept walk-in registrations on the day of the meeting for any remaining time slots on a first-come, first-served basis, beginning at 8:30 a.m.

The regional meetings are open to the public. Registration is not required to observe the regional meetings. However, due to capacity limitations, space may be limited. Admission to observe the meetings will be provided on a first-come, first-served basis. Space for speakers will be reserved. The regional meeting in Washington, DC will be streamed live at: http://edstream.ed.gov/webcast/Play/7592f68fb7404eedb2b89ea72032188c1d.

If you need a sign language interpreter or any other accommodation for the regional meeting, please notify the program contact person listed under FOR FURTHER INFORMATION CONTACT at least seven days prior to the meeting you plan to attend, and indicate in your request which meeting you plan to attend.

The Department will post transcriptions of the hearings on the Department's Web site. The Department will be livestreaming the meeting in Washington, DC, but will not be filming the meeting in Los Angeles. As these are both public meetings, speakers should be aware that they may be filmed or recorded by members of the public.

Speakers, including any prospective presenter whose request to speak is rejected due to time limitations or other considerations, may also submit written comments at the regional meetings. In addition, the Department will accept written comments through January 21, 2016. See the ADDRESSES sections of this document for more information on how to submit comments.

Accessible Format: Individuals with disabilities can obtain this document in an accessible format (e.g., braille, large print, audiotape, or compact disc) on request to the program contact person listed under FOR FURTHER INFORMATION CONTACT.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register. Free Internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.thefederalregister.org/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Adobe Portable Document Format (PDF). To use PDF you must have Adobe Acrobat Reader, which is available free at the site.

You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Section 610 of the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), requires agencies to conduct periodic reviews of final rules that have a significant economic impact on a substantial number of small business entities. The purpose of the reviews is to determine whether such rules should be continued without change, or should be amended or rescinded, consistent with the objectives of applicable statutes, to minimize any significant economic impact of the rules on a substantial number of such small entities.

On November 24, 2008, NHTSA published in the Federal Register (73 FR 71401) a 10-year review plan for its existing regulations. The National Highway Traffic Safety Administration (NHTSA, “we”) has divided its rules into 10 groups by subject area. Each group will be reviewed once every 10 years, undergoing a two-stage process—an Analysis Year and a Review Year. For purposes of these reviews, a year will coincide with the fall-to-fall publication schedule of the Semiannual Regulatory Agenda, see http://www.regulations.gov. Year 1 (2008) begins in the fall of 2008 and ends in the fall of 2009; Year 2 (2009) begins in the fall of 2009 and ends in the fall of 2010; and so on.

During the Analysis Year, we will request public comment on and analyze each of the rules in a given year's group to determine whether any rule has a significant impact on a substantial number of small entities and, thus, requires review in accordance with section 610 of the Regulatory Flexibility Act. In each fall's Regulatory Agenda, we will publish the results of the analyses we completed during the previous year. For rules that have subparts, or other discrete sections of rules that do have a significant impact on a substantial number of small entities, we will announce that we will be conducting a formal section 610 review during the following 12 months.

The section 610 review will determine whether a specific rule should be revised or revoked to lessen its impact on small entities. We will consider: (1) The continued need for the rule; (2) the nature of complaints or comments received from the public; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates, or conflicts with other federal rules or with state or local government rules; and (5) the length of time since the rule has been evaluated or the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule. At the end of the Review Year, we will publish the results of our review. The following table shows the 10-year analysis and review schedule:

During Year 8, we will continue to conduct a preliminary assessment of the following sections of 49 CFR 571.201 through 571.212:

We are seeking comments on whether any requirements in 49 CFR 571.201 through 571.212 have a significant economic impact on a substantial number of small entities. “Small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations under 50,000. Business entities are generally defined as small businesses by Standard Industrial Classification (SIC) code, for the purposes of receiving Small Business Administration (SBA) assistance. Size standards established by SBA in 13 CFR 121.201 are expressed either in number of employees or annual receipts in millions of dollars, unless otherwise specified. The number of employees or annual receipts indicates the maximum allowed for a concern and its affiliates to be considered small. If your business or organization is a small entity and if any of the requirements in 49 CFR 571.201 through 571.212 have a significant economic impact on your business or organization, please submit a comment to explain how and to what degree these rules affect you, the extent of the economic impact on your business or organization, and why you believe the economic impact is significant.

If the agency determines that there is a significant economic impact on a substantial number of small entities, it will ask for comment in a subsequent notice during the Review Year on how these impacts could be reduced without reducing safety.

Executive Order 12866 and the Presidential memorandum of June 1, 1998 entitled “Plain Language in Government Writing” require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that is not clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please include them in your comments on this document.

In conjunction with our section 610 reviews, we will be performing plain language reviews over a ten-year period on a schedule consistent with the section 610 review schedule. We will review 49 CFR 571.201 through 571.212 determine if these regulations can be reorganized and/or rewritten to make them easier to read, understand, and use. We encourage interested persons to submit draft regulatory language that clearly and simply communicates regulatory requirements, and other recommendations, such as for putting information in tables that may make the regulations easier to use.

Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number of this document in your comments.

Your comments must not be more than 15 pages long. (49 CFR 553.21.) We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.

Please submit one copy of your comments, including the attachments, to Docket Management at the address given above under ADDRESSES.

Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at http://www.whitehouse.gov/omb/fedreg_reproducible. DOT's guidelines may be accessed at http://dmses.dot.gov/submit/DataQualityGuidelines.pdf.

Privacy Act: Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://www.regulations.gov.

If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.

If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590. In addition, you should submit a copy, from which you have deleted the claimed confidential business information, to Docket Management at the address given above under ADDRESSES. When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation. (49 CFR part 512.)

We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under DATES. To the extent possible, we will also consider comments that Docket Management receives after that date.

You may read the comments received by Docket Management at the address given above under ADDRESSES. The hours of the Docket are indicated above in the same location.

You may also see the comments on the Internet. To read the comments on the Internet, take the following steps:

(1) Go to the Federal Docket Management System (FDMS) at http://www.regulations.gov.

(2) FDMS provides two basic methods of searching to retrieve dockets and docket materials that are available in the system: (a) “Quick Search” to search using a full-text search engine, or (b) “Advanced Search,” which displays various indexed fields such as the docket name, docket identification number, phase of the action, initiating office, date of issuance, document title, document identification number, type of document, Federal Register reference, CFR citation, etc. Each data field in the advanced search may be searched independently or in combination with other fields, as desired. Each search yields a simultaneous display of all available information found in FDMS that is relevant to the requested subject or topic.

(3) You may download the comments. However, since the comments are imaged documents, instead of word processing documents, the “pdf” versions of the documents are word searchable.

Please note that even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.

Why we need to publish a rule. Under the Act, if we determine that a species is an endangered or threatened species throughout all or a significant portion of its range, we must publish a proposed rule to list the species in the Federal Register and make a determination on our proposal within 1 year. Listing a species as an endangered or threatened species can only be completed by issuing a rule.

This rule proposes the listing of the Miami tiger beetle (Cicindelidia floridana) as an endangered species. This rule assesses all available information regarding the status of and threats to the Miami tiger beetle.

The basis for our action. Under the Act, we may determine that a species is an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. We have determined that the threats to the Miami tiger beetle consist of habitat loss, degradation, fragmentation, and proposed future development of habitat (Factor A); collection, trade, and sale (Factor B); inadequate protection from existing regulatory mechanisms (Factor D); and a small isolated population with a restricted geographical range, limited genetic exchange, and restricted dispersal potential that is subject to demographic and environmental stochasticity, including climate change and sea level rise (Factor E).

We will seek peer review. We will invite independent specialists (peer reviewers) to comment on our listing proposal to ensure that it is based on scientifically sound data, assumptions, and analyses.

We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from other concerned governmental agencies, Native American tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. We particularly seek comments concerning:

(1) The Miami tiger beetle's biology, range, population trends, and habitat, including:

(a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

(b) Taxonomy, including genetic information;

(c) Historical and current range, including distribution patterns and dispersal distances;

(d) Historical and current range or distribution, including the locations of any additional occurrences of the beetle, population levels, current and projected population trends, and viability;

(e) Past and ongoing conservation measures for the species, its habitat, or both;

(f) Survey methods appropriate to detect trends in tiger beetle population distribution and abundance; and

(g) The use of previously undocumented or altered habitat types (e.g., use of road edges and fire breaks), especially in areas that may not be burned regularly.

(2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization (e.g., collection, sale, or trade), disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.

(3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to the species and existing regulations that may be addressing those threats.

(4) Current or planned activities in the areas occupied by the species and possible impacts of these activities on the species.

(5) Overutilization for commercial, recreational, scientific, or educational purposes, including information regarding over-collection at permitted sites, evidence of collection or collection rates in general, and recreational or commercial trade and sale.

(6) The following specific information on:

(a) The amount and distribution of habitat for the Miami tiger beetle;

(b) Any occupied or unoccupied areas that are essential for the conservation of the species and why;

(c) Special management considerations or protections that may be needed for the essential features in potential critical habitat areas, including managing for the potential effects of climate change.

Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

Because we will consider comments and all other information we receive during the public comment period, our final determination may differ from this proposal.

Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act (16 U.S.C. 1531 et seq.) directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”

You may submit your comments and materials concerning this proposed rule by one of the methods listed in the ADDRESSES section. We request that you send comments only by the methods described in the ADDRESSES section.

If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. A public hearing will be held on January 13, 2016 from 6:00 p.m. to 9:00 p.m. at Miami Dade College—Kendall Campus, Building 6000, 11011 SW 104th Street, Miami, Florida 33176-3396.

In accordance with our joint policy with the National Marine Fisheries Service on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), we are seeking expert opinions of appropriate and independent specialists regarding this proposed rule. The purpose of peer review is to ensure that our proposed listing actions are based on scientifically sound data, assumptions, and analyses. The peer reviewers have expertise in insect biology, habitat, physical or biological factors, and so forth, which will inform our determination. We invite comment from these peer reviewers during this public comment period.

In 2013, we began assessing the status and threats to the Miami tiger beetle and considering the need to add the beetle to the List of Endangered and Threatened Wildlife. On December 11, 2014, we received a petition from the Center for Biological Diversity (CBD), the Miami Blue Chapter of the North American Butterfly Association, South Florida Wildlands Association, Tropical Audubon Society, Sandy Koi, Al Sunshine, and Chris Wirth requesting that the Miami tiger beetle be emergency listed as endangered, and that critical habitat be designated under the Act (CBD et. al. 2014, entire). The petition clearly identified itself as such and included the requisite identification information for the petitioner, as required by title 50 of the Code of Federal Regulations (CFR) at section 424.14(a) (50 CFR 424.14(a)). In a February 13, 2015, letter to the petitioners, we acknowledged receipt of the petition and stated that although we determined that emergency listing was not warranted, we would review the petitioned request for listing. The Service's review concluded that listing was warranted, and that we should proceed in an expeditious manner with the proposed listing of the species under the Act. Therefore, this document also constitutes, in addition to the proposed listing, both our 90-day and 12-month findings on the petition to list the Miami tiger beetle.

The Miami tiger beetle is an elongate beetle with an oval shape and bulging eyes, and is one of the smallest (6.5-9.0 millimeters (mm) (0.26-0.35 inches (in))) tiger beetles in the United States (Knisley 2015a, p. 3; 2015b, p. 3). The underside of the abdomen is orange to orange-brown in color like many other Cicindelidia species (Pearson 1988, p. 134; Knisley 2015a, p. 3; Knisley 2015b, p. 3). The Miami tiger beetle is uniquely identified by the shiny dark green dorsal surface, sometimes with a bronze cast and, without close examination in the field, may appear black; the pair of green hardened forewings covering the abdomen (elytra) have reduced white markings (maculations) consisting only of a small patch at the posterior tip of each elytron (Brzoska et al. 2011, pp. 2-6).

As is typical of other tiger beetles, adult Miami tiger beetles are active diurnal predators that use their keen vision to detect movement of small arthropods and run quickly to capture prey with their well-developed jaws (mandibles). Observations by various entomologists indicate small arthropods, especially ants, are the most common prey for tiger beetles. Choate (1996, p. 2) indicated ants were the most common prey of tiger beetles in Florida. Willis (1967, pp. 196-197) lists over 30 kinds of insects from many families as prey for tiger beetles, and scavenging is also common in some species (Knisley and Schultz 1997, pp. 39, 103).

Tiger beetle larvae have an elongate, white, grub-like body and a dark or metallic head with large mandibles. Larvae are sedentary sit-and-wait predators occurring in permanent burrows flush with the ground surface (Essig 1926, p. 372; Essig 1942, p. 532; Pearson 1988, pp. 131-132). When feeding, larvae position themselves at the burrow mouth and quickly strike at and seize small arthropods that pass within a few centimeters (cm) of the burrow mouth (Essig 1942, pp. 531-532; Pearson 1988, p. 132). An enlarged dorsal portion of the fifth abdominal segment, with two pairs of hooks, anchors the larvae into its permanent burrow while the upper portion of the body extends to capture prey (Pearson 1988, p. 127; Choate 1996, p. 2). Larvae prey on small arthropods, similar to adults.

The Miami tiger beetle (Cicindelidia floridana Cartwright) is a described species in the Subfamily Cicindelinae of the Family Carabidae (ground beetles). Previously, tiger beetles were considered a separate family, but are now classified as a subfamily of the family Carabidae on the basis of recent genetic studies and other characters (Bousquet 2012, p. 30). The Miami tiger beetle is in the C. abdominalis group that also includes the eastern pinebarrens tiger beetle (C. abdominalis), scrub tiger beetle (C. scabrosa), and Highlands tiger beetle (C. highlandensis). New treatments of tiger beetles (Bousquet 2012, p. 30; Pearson et al. 2015, p. 138) have also elevated most of the previous subgenera of tiger beetles to genera, resulting in a change of the genus of the tiger beetles in the C. abdominalis group from Cicindela to Cicindelidia. These genera were originally proposed by Rivalier (1954, entire) and are widely used by European scientists (Wiesner 1992, entire), but are considered subgenera by many American scientists. The return to Rivalier's system has also been supported by a new study using genetic evidence (Duran and Gwiazdowski, in preparation).

The four species in the Cicindelidia abdominalis group all share a small body size (7-11 mm (0.28-0.43 in) long) and orange underside, and they occur in inland sandy habitats. The four beetles maintain separate ranges along the U.S. east coast and exhibit a significant gradient in range size: The eastern pinebarrens tiger beetle occurs from New York south along the coastal plain to north Florida; the scrub tiger beetle is present throughout much of peninsular Florida, south to Ft. Lauderdale; the Highlands tiger beetle is restricted to the Lake Wales Ridge of Highlands and Polk Counties, Florida; and the Miami tiger beetle is found only in Miami-Dade County, Florida.

The Miami tiger beetle was first documented from collections made in 1934, by Frank Young (see Distribution, below). There were no observations after this initial collection, and the species was thought to be extinct until it was rediscovered in 2007, at the Zoo Miami Pine Rockland Preserve in Miami-Dade County. The rediscovery of a Miami tiger beetle population provided additional specimens to the 1934 collection and prompted a full study of its taxonomic status, which elevated it to a full species, Cicindelidia floridana (Brzoska et al. 2011, entire).

The Miami tiger beetle is distinguished from the three other species of the abdominalis group based on: (1) Morphology (color, maculation (spots or markings), and elytral (modified front wing) microsculpture); (2) distribution; (3) habitat requirements; and (4) seasonality (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138). This array of distinctive characters is comparable to the characters used to separate the other three species of the C. abdominalis group.

Although color is often variable and problematic as a sole diagnostic trait in tiger beetles, it is useful when combined with other factors (Brzoska et al. 2011, p. 4). In comparison with the closely related scrub tiger beetle, the Miami tiger beetle has a green or bronze-green elytra, rarely with a post median marginal spot, and without evidence of a middle band, while the scrub tiger beetle has a black elytra, with a post median marginal spot, usually with a vestige of a middle band (Brzoska et al. 2011, p. 6) (see Brzoska et al. 2011 for detailed description, including key). There are also noticeable differences in the width of the apical lunule (crescent shape), with the Miami tiger beetle's being thin and the scrub tiger beetle's medium to thick.

In addition, the Miami tiger beetle has a narrower, restricted range where its distribution does not overlap with the other three species in the C. abdominalis group (i.e., the Miami tiger beetle has only been documented in Miami-Dade County). The Miami tiger beetle also occupies a unique habitat type (i.e., pine rockland versus scrub or open sand and barren habitat).

Lastly, the Miami tiger beetle has a broader period of adult activity than the “late spring to mid-summer” cycle that is observed in the scrub tiger beetle (Brzoska et al. 2011, p. 6) (see also Distribution, Habitat, and Biology sections, below). Adult Miami tiger beetles have been observed from early May through mid-October; this is an unusually long flight period that suggests either continual emergence or two emergence periods (Brzoska et al. 2011, p. 6). In summary, the Miami tiger beetle is recognized as a distinct full species, based upon its differences in morphology, distribution, habitat, and seasonality (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138).

Genetic analyses for the Miami tiger beetle to date are limited to one nonpeer-reviewed study, and available techniques (e.g., genomics, which can better study the process of speciation) are evolving. A limited genetic study using mitochondrial DNA (mtDNA) suggested that the eastern pinebarrens tiger beetle, Highlands tiger beetle, scrub tiger beetle, and Miami tiger beetle are closely related and recently evolved (Knisley 2011a, p. 14). As with other similar Cicindela groups, these three sister species were not clearly separable by mtDNA analysis alone (Knisley 2011a, p. 14). The power of DNA sequencing for species resolution is limited when species pairs have very recent origins, because in such cases new sister species will share alleles for some time after the initial split due to persistence of ancestral polymorphisms, incomplete lineage sorting, or ongoing gene flow (Sites and Marshall 2004, pp. 216-221; McDonough et al. 2008, pp. 1312-1313; Bartlett et al. 2013, pp. 874-875). Changing sea levels and coincidental changes in the size of the land mass of peninsular Florida during the Pleistocene Era (2.6 million years ago to 10,000 years ago) is thought to be the key factor in the very recent evolutionary divergence and speciation of the three Florida species from C. abdominalis (Knisley 2015a, p. 5; Knisley 2015b, p. 4). Despite the apparent lack of genetic distinctiveness from the one non peer-reviewed, limited genetic study, tiger beetle experts and peer-reviewed scientific literature agree that based on the morphological uniqueness, geographic separation, habitat specialization, and extended flight season, the Miami tiger beetle warrants species designation (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138).

The most current peer-reviewed scientific information confirms that Cicindelidia floridana is a full species, and this taxonomic change is used by the scientific community (Brzoska et al. 2011, entire; Bousquet 2012, p. 313; Pearson et al. 2015, p. 138; Integrated Taxonomic Information System (ITIS), 2015, p. 1). One source researched for the Miami tiger beetle's taxonomic designation is the ITIS, which was created by a White House Subcommittee on Biodiversity and Ecosystem Dynamics to provide scientifically credible taxonomic information and standardized nomenclature on species. The ITIS is partnered with Federal agencies, including the Service, and is used by agencies as a source for validated taxonomic information. The ITIS recognizes the Miami tiger beetle as a valid species (ITIS, 2015, p. 1). Both the ITIS (2015, p. 1) and Bousquet (2012, p. 313) continue to use the former genus, Cicindela (see discussion above). The Florida Natural Areas Inventory (FNAI) (2015, p. 16) and NatureServe (2015, p. 1) also accept the Miami tiger beetle's taxonomic status as a species and use the new generic designation, Cicindelidia. In summary, although there is some debate about the appropriate generic designation (Cicindelidia versus Cicindela) based upon the best available scientific information, the Miami tiger beetle is a valid species.

The historical range of the Miami tiger beetle is not completely known, and available information is limited based on the single historical observation prior to the species' rediscovery in 2007. It was initially documented from collections made in 1934, by Frank Young within a very restricted range in the northern end of the Miami Rock Ridge, in a region known as the Northern Biscayne Pinelands. The Northern Biscayne Pinelands, which extend from the city of North Miami south to approximately SW 216th Street, are characterized by extensive sandy pockets of quartz sand, a feature that is necessary for the Miami tiger beetle (see Habitat section, below) (Service 1999, p. 3-162). The type locality (the place where the specimen was found) was likely pine rockland habitat, though the species is now extirpated from the area (Knisley and Hill 1991, pp. 7, 13; Brzoska et al. 2011, p. 2; Knisley 2015a, p. 7). The exact location of the type locality in North Miami was determined by Rob Huber, a tiger beetle researcher who contacted Frank Young in 1972. Young recalled collecting the type specimens while searching for land snails at the northeast corner of Miami Avenue and Gratigny Road (119th Street), North Miami. Huber checked that location the same year and found that a school had been built there. A more thorough search for sandy soil habitats throughout that area found no potential habitat (Knisley and Hill 1991, pp. 7, 11-12). Although the contact with Young did not provide habitat information for the type locality, a 1943 map of habitats in the Miami area showed pine rockland with sandy soils reaching their northern limit in the area of the type locality (Knisley 2015a, p. 27), and Young's paper on land snails made reference to pine rockland habitat (Young 1951, p. 6). Recent maps, however, show that the pine rockland habitat has been mostly developed from this area, and remaining pine rockland habitat is mostly restricted to Miami-Dade County owned sites in south Miami (Knisley 2015a, p. 7). In summary, it is likely that the Miami tiger beetle historically occurred throughout pine rockland habitat on the Miami Rock Ridge.

The Miami tiger beetle was thought to be extinct until 2007, when a population was discovered at the Richmond Heights area of south Miami, Florida, known as the Richmond Pine Rocklands (Brzoska et al. 2011, p. 2; Knisley 2011a, p. 26). The Richmond Pine Rocklands is a mixture of publically and privately owned lands that retain the largest area of contiguous pine rockland habitat within the urbanized areas of Miami-Dade County and outside of the boundaries of Everglades National Park (ENP). Surveys and observations conducted at Long Pine Key in ENP have found no Miami tiger beetles, and habitat conditions are considered unsuitable for the species (Knisley 2015a, p. 42; J. Sadle, 2015, pers. comm.). At this time, known extant occurrences are found on four contiguous sites of pine rockland habitat in the Richmond Pine Rocklands: (1) Zoo Miami Pine Rockland Preserve (Zoo Miami) (293 hectares (ha); 723 acres (ac)), (2) Larry and Penny Thompson Park (121 ha; 300 ac), (3) U.S. Coast Guard property (USCG) (96 ha; 237 ac), and (4) University of Miami's Center for Southeastern Tropical Advanced Remote Sensing property (CSTARS) (31 ha; 76 ac). Most recently (September 2015), Miami tiger beetles were found outside of and within approximately 5.0 km (3.1 mi) of the four Richmond Pine Rockland parcels listed above. Based on historical records, current occurrences, and habitat needs of the species (see Habitat section, below), the current range of the species is considered to be any pine rockland habitat (natural or disturbed) within the Miami Rock Ridge (Knisley 2015a, p. 7; CBD et al. 2014, pp. 13-16, 31-32).

The Miami tiger beetle is extremely rare and only known to occur in two separate locations within pine rockland habitat in Miami-Dade County. The Richmond population occurs on four contiguous parcels within the Richmond Pine Rocklands: Zoo Miami, Larry and Penny Thompson Park, CSTARS, and USCG. The second location, which was recently identified, is within approximately 5.0 km (3.1 mi) of the Richmond population and separated by urban development (D. Cook, 2015, pers. comm.).

Miami tiger beetles within the four contiguous occupied parcels in the Richmond population are within close proximity to each other. There are apparent connecting patches of habitat and few or no barriers (contiguous and border each other on at least one side) between parcels. Given the contiguous habitat with few barriers to dispersal, frequent adult movement among individuals is likely, and the occupied Richmond parcels probably represent a single population (Knisley 2015a, p. 10). Information regarding Miami tiger beetles at the new location is very limited, but beetles here are within approximately 5.0 km (3.1 mi) of the Richmond population and separated by ample urban development, which likely represents a significant barrier to dispersal, and the Miami tiger beetles at the new location are currently considered a second population.

The Richmond population occurs within an approximate 2 square kilometer (km2) (494 ac) block, but currently much of the habitat is overgrown with vegetation, leaving few remaining open patches for the beetle. Survey data documented a decline in the number of open habitat patches, and Knisley (2015a, pp. 9-10) estimated that less than 10 percent of the mostly pine rockland habitat within this area supports the species in its current condition.

Based on surveys to date, the Miami tiger beetle is found exclusively on the Miami Rock Ridge within the urbanized areas of Miami-Dade County and outside the boundaries of ENP (Knisley 2015a, pp. 6-7). This area extends from the ENP boundary, near the Park entrance road, northeast approximately 72 km (45 miles (mi)) to its end near North Miami. The pine rocklands are a unique ecosystem found on limestone substrates in three areas in Florida: The Miami Rock Ridge, the Florida Keys, and the Big Cypress Swamp. The pine rocklands differ to some degree between and within these three areas with regard to substrate (e.g., amount of exposed limestone, type of soil), elevation, hydrology, and species composition (both plant and animal).

Pine rockland occurs on relatively flat terrain, approximately 2.0-7.0 m (6.5-23.0 ft) above sea level with an average elevation of approximately 3.0 m (9.8 ft) (Service 1999, p. 3-167; FNAI 2010, p. 62). On the Miami Rock Ridge, oolitic limestone is at or very near the surface, and solution holes occasionally form where the surface limestone is dissolved by organic acids. There is typically very little soil development, consisting primarily of accumulations of low-nutrient sand, marl, clayey loam, and organic debris found in solution holes, depressions, and crevices on the limestone surface (FNAI 2010, p. 62). However, sandy pockets can be found at the northern end of the Miami Rock Ridge, beginning from approximately the city of North Miami Beach and extending south to approximately to SW 216 Street (Service 1999, p. 3-162). These microhabitat parameters (e.g., bare patches of sandy soil) are absent or limited throughout most of the extant pine rockland habitat (URS et al. 2007, p. 5).

Pine rockland has an open canopy of South Florida slash pine, generally with multiple age classes. The diverse, open shrub and subcanopy layer is composed of more than 100 species of palms and hardwoods (FNAI 2010, p. 1), most derived from the tropical flora of the West Indies (FNAI 2010, p. 1). These vegetative layers and habitat conditions (e.g., canopy height, percent cover, density) change depending upon fire frequency, fire intensity, and other factors. Plant composition includes species such as Serenoa repens (saw palmetto), Sabal palmetto (cabbage palm), Coccothrinax argentata (silver palm), Thrinax morrisii (brittle thatch palm), Morella cerifera. (wax myrtle), Myrsine floridana (myrsine), Metopium toxiferum (poisonwood), Byrsonima lucida (locustberry), Dodonaea viscosa (varnishleaf), Tetrazygia bicolor (tetrazygia), Guettarda scabra (rough velvetseed), Ardisia escallonioides (marlberry), Mosiera longipes (mangrove berry), Sideroxylon salicifolium (willow bustic), and Rhus copallinum (winged sumac). Short-statured shrubs include Quercus pumila (running oak), Randia aculeata (white indigoberry), Crossopetalum ilicifolium (Christmas berry), Morinda royoc (redgal), and Chiococca alba (snowberry).

Grasses, forbs, and ferns make up a diverse herbaceous layer ranging from mostly continuous in areas with more soil development and little exposed rock to sparse where more extensive outcroppings of rock occur. Typical herbaceous species include Andropogon spp., S. rhizomatum, and S. sanguineum (bluestems), Aristida purpurascens (arrowleaf threeawn), Sorghastrum secundum (lopsided indiangrass), Muhlenbergia capillaris (hairawn muhly), Rhynchospora floridensis (Florida white-top sedge), Tragia saxicola (pineland noseburn), Echites umbellatus (devil's potato), Croton linearis (pineland croton), several species of Chamaesyce spp. (sandmats), Chamaecrista fasciculata (partridge pea), Zamia pumila (coontie), Anemia adiantifolia (maidenhair pineland fern), Pteris bahamensis (Bahama brake), and Pteridium var. caudatum (lacy bracken) (FNAI 2010, p. 1).

Pine rockland habitat is maintained by regular fire, and is susceptible to other natural disturbances such as hurricanes, frost events, and sea-level rise (SLR) (Ross et al. 1994, p. 144). Fires historically burned on an interval of approximately every 3 to 7 years (FNAI 2010, p. 3), and were typically started by lightning strikes during the frequent summer thunderstorms (FNAI 2010, p. 3).

Presently, prescribed fire must be periodically introduced into pine rocklands to sustain community structure, prevent invasion by woody species, maintain high herbaceous diversity (Loope and Dunevitz 1981, pp. 5-6; FNAI 2010, p. 3), and prevent succession to rockland hammock. The amount of woody understory growth is directly related to the length of time since the last fire (FNAI 2010, p. 3). Herbaceous diversity declines with time since the last fire. The ecotone between pine rockland and rockland hammock is abrupt when regular fire is present in the system. However, when fire is removed, the ecotone becomes more gradual and subtle as hammock hardwoods encroach into the pineland (FNAI 2010, p. 3).

The lifecycle of the Miami tiger beetle occurs entirely within the pine rocklands. Adult Miami tiger beetles require patches of open sandy areas within the pine rocklands for behavioral thermoregulation (avoiding or seeking sources of heat to regulate body temperature) so that they can successfully capture small arthropod prey (Knisley 2015a, p. 8). They are visual hunters that use keen eyesight to locate and rapid movement to capture small arthropods. Females oviposit (lay eggs) in these same bare patches (Knisley 2015a, p. 8). The larvae, which are sit-and-wait predators, can capture prey and complete development in sandy areas, without interference from encroaching vegetation (Knisley 2015a, p. 8). At most of the remaining pine rockland sites on the Miami Rock Ridge, bare patches of sandy soil are absent or limited (URS et al. 2007, p. 5) (see “Microhabitat,” below).

Microhabitat conditions are not completely understood, due in part to few known occurrences and limited surveys at some parcels. At the Zoo Miami parcel, which was most thoroughly surveyed, adults and larvae were restricted to a small number of scattered patches of bare ground. The patches were small, typically 2 to 6 square meters (m2) (22 to 65 square feet (ft2)) in size and ovoid to linear in shape with encroaching and overhanging vegetation around the edges and with 15-30 percent ground cover of leaf, grass, and plant litter (Knisley 2015a, p. 8). Patches smaller than 2 to 6 m2 (22-65 ft2) typically had no adults (Knisley 2015a, p. 8). Some of the more linear patches were apparent current or past trails or paths, possibly maintained by animal activity. Soil in these open patches where adults and larvae were found was classified as sandy to loamy sand with primarily very fine (0.130 mm (0.005 in)) to medium grain (0.50 mm (0.02 in)), white to gray colored sand with less than 5 percent organic matter (Knisley 2011a, p. 32). Soil depth was 15.24 cm or more (6.00 in), and moist below the surface (Knisley 2015a, p. 8). This microhabitat is different from that used by either the Highlands or scrub tiger beetles, which in Florida are typically found in much larger, naturally open patches among the vegetation (usually greater than 25 m2 (269 ft2)) or along open paths, roads, and scrub edges (Knisley 2015a, p. 8). The sand for these other species is also white “sugar” sand, which is very deep, drier, and with less organic matter mixed in (Knisley 2015a, pp. 8-9).

In tiger beetles, the adult female determines the habitat and microhabitat of the larva by the selection of an oviposition (egg-laying) site (Knisley and Schultz 1997, p. 28). Generally, the same microhabitats are occupied by both larvae and adults. Females will often touch the soil with the antennae, bite it, and even dig trial holes, possibly to determine suitable soil characteristics (Willis 1967, p. 194) before placing a single egg into a shallow oviposition burrow (1 to 2 cm (0.39 to 0.79 in)) dug into the soil with the ovipositor. The egg hatches, apparently after sufficient soil wetting, and the first instar larvae digs a burrow at the site of oviposition. Development in tiger beetles includes three larval instars followed by a pupal and adult stage. In most species of tiger beetles, development requires 2 years, but can range from 1 to 4 or more years depending on climate and food availability. The life cycle of most tiger beetles in the United States follows either a summer or spring-fall adult activity pattern (Knisley and Schultz 1997, pp. 19-21). These life cycles patterns all indicate the length of the adult flight season is typically 2 to 3 months, but the life span of individual adults is likely to be less.

Based on available information, the Miami tiger beetle appears to have only limited dispersal abilities. Among tiger beetles there is a general trend of decreasing flight distance with decreasing body size (Knisley and Hill 1996, p. 13). The Miami tiger beetle is one of the smallest tiger beetles (less than half an inch in length); it is likely to be a weak flier based on its size and the limited flight distance of the closely related Highlands tiger beetle (usually flying only 5-10 m (16.4-32.8 ft)) (Knisley and Hill 2013, p. 39). Additionally, tiger beetle species in woodland, scrub, or dune habitats seem to disperse less than water edge species, and this could further explain the apparent limited dispersal of the species (Knisley and Hill 1996, p. 13). Evidence for longer distance dispersal has been reported for some tiger beetle species, but these are generally larger, coastal species that occupy more widespread habitats and use frequent winds or coastal storms to aid in dispersal. For example, a dispersal distance of 160 km (99 mi) was reported for the s-banded tiger beetle (Cicindelidia trifasciata), a coastal mud flat species, that was found in light traps on offshore oil platforms in the Gulf of Mexico (Graves 1981, pp. 45-47). Similarly, extensive mark and recapture studies of the northeastern beach tiger beetle (Cicindela dorsalis), a water edge species approximately twice the size of the Miami tiger beetle, found that the majority of marked adults moved 2 km (1.2 mi) or less, but a few individuals moved over 15-30 km (9-19 mi), some of which required crossing open water (Service 1993, pp. 15-17). Dispersal by storms is unknown to occur in the Miami tiger beetle, and is unlikely to be a successful dispersal strategy as the species is only known to occur in a narrowly distributed habitat type (i.e., remaining pine rocklands) that is interspersed among unsuitable habitat and mixed land uses within a restricted geographical range.

As a group, tiger beetles occupy ephemeral habitats where local extinction from habitat loss or degradation is common, so dispersal to establish new populations in distant habitat patches is a likely survival strategy for most species (Knisley 2015b, p. 10). Limited dispersal capabilities and other constraints (e.g., few populations, limited numbers, and barriers created by intervening unsuitable habitat), however, can disrupt otherwise normal metapopulation dynamics and contribute to imperilment.

Results of monthly surveys at the Zoo Miami parcel in 2009, and additional late summer and fall surveys through 2014, indicated the adult flight period for the Miami tiger beetle ranges from May 15 through October 17 (Knisley 2015a, p. 5). No adults were found during an April 18 survey, meaning emergence had not yet occurred (Knisley 2015a, p. 6). In 2009, only two adults were found on September 2, either because conditions were not ideal (although they seemed to be suitable) or activity may have ended earlier in the year. In 2014, some adults were active on September 10 and 30, but not on October 14. This 5-month long adult flight period is unusual in tiger beetles and is much longer than the seasonality of the other three species in the C. abdominalis group with ranges in Florida (Knisley 2015a, p. 6).

There is no clear explanation for the long adult flight period of the Miami tiger beetle, but it is possible that there are two cohorts of Miami tiger beetle adults emerging during this period (Knisley 2015a, p. 6). Adults emerging in May and June would mate, oviposit, and produce larvae that could develop and emerge as a second cohort of adults in late July and August as the earlier cohort of adults were dying off. Larvae from these later active adults would develop through fall and winter, emerging as adults the following May. The rapid completion of development within 2 months would not be unusual given the small size of this species and the continually warm temperatures in south Florida (Knisley 2015a, p. 6). Rate of development is likely increased during the summer rainy season when prey is more abundant (Knisley 2015a, p. 6).

The visual index count is the standard survey method that has been used to determine presence and abundance of the Miami tiger beetle. Using this method, surveyors either walk slowly or stand still in appropriate open habitats, while taking a count of any beetle observations. Although the index count has been the most commonly used method to estimate the population size of adult tiger beetles, various studies have demonstrated it significantly underestimates actual numbers present. As noted earlier, several studies comparing various methods for estimating adult tiger beetle abundance have found numbers present at a site are typically 2 to 3 times higher than that produced by the index count (Knisley and Schultz 1997, p. 15; Knisley 2009, entire; Knisley and Hill 2013, pp. 27, 29; S. Spomer, 2014, pers. comm.). Numbers are underestimated because tiger beetles are elusive, and some may fly off before being detected while others may be obscured by vegetation in some parts of the survey area. Even in defined linear habitats like narrow shorelines where there is no vegetation and high visibility, index counts produce estimates that are 2 to 3 times lower than the numbers present (Knisley and Schultz 1997, p. 152).

Information on the Richmond population size is limited because survey data are inconsistent, and some sites are difficult to access due to permitting, security, and liability concerns. Of the occupied sites, the most thoroughly surveyed site for adult and larval Miami tiger beetles is the Zoo Miami parcel (over 30 survey dates from 2008 to 2014) (Knisley 2015a, p. 10). Adult beetle surveys at the CSTARS and USCG parcels have been infrequent, and access was not permitted in 2012 through early summer of 2014. In October 2014, access to both the CSTARS and USCG parcels was permitted, and no beetles were observed during October 2014 surveys. As noted earlier, Miami tiger beetles were recently found at Larry and Penny Thompson Park (D. Cook, 2015, pers. comm.); however, thorough surveys at this location have not been conducted. For details on index counts and larval survey results from the three surveyed parcels (Zoo Miami, USCG, and CSTARS), see Table 2 in Supporting Documents on http://www.regulations.gov.

Raw index counts found adults in four areas (Zoo A, Zoo B, Zoo C, and Zoo D) of the Zoo Miami parcel. Two of these patches (Zoo C and Zoo D) had fewer than 10 adults during several surveys at each. Zoo A, the more northern site where adults were first discovered, had peak counts of 17 and 22 adults in 2008 and 2009, but declined to 0 and 2 adults in six surveys from 2011 to 2014, despite thorough searches on several dates throughout the peak of the adult flight season (Knisley 2015, pp. 9-10). Zoo B, located south of Zoo A, had peak counts of 17 and 20 adults from 2008 to 2009, 36 to 42 adults from 2011 to 2012, and 13 and 18 adults in 2014 (Knisley 2015a, pp. 9-10). These surveys at Zoo A and Zoo B also recorded the number of suitable habitat patches (occupied and unoccupied). Surveys between 2008 and 2014 documented a decline in both occupied and unoccupied open habitat patches. Knisley (2015, pp. 9-10) documented a decrease at Zoo A from 7 occupied of 23 patches in 2008, to 1 occupied of 13 patches in 2014. At Zoo B, there was a decrease from 19 occupied of 26 patches in 2008, to 7 occupied of 13 patches in 2014 (Knisley 2015, pp. 9-10). Knisley (2015a, p. 10) suggested this decline in occupied and unoccupied patches is likely the result of the vegetation that he observed encroaching into the open areas that are required by the beetle.

At the CSTARS site, the only survey during peak season was on August 20, 2010, when much of the potential habitat was checked. This survey produced a raw count of 38 adults in 11 scattered habitat patches, with 1 to 9 adults per patch, mostly in the western portion of the site (Knisley 2015a, p. 10). Three surveys at the USCG included only a portion of the potential habitat and produced raw adult counts of two, four, and two adults in three separate patches from 2009, 2010, and 2011, respectively (Knisley 2015a, p. 10). Additional surveys of the CSTARS and the USCG parcels on October 14 to 15, 2014, surveyed areas where adults were found in previous surveys and some new areas; however, no adults were observed. The most likely reasons for the absence of adults were because counts even during the peak of the flight season were low (thus detection would be lower off-peak), and mid-October is recognized as the end of the flight season (Knisley 2014a, p. 2). As was noted for the Zoo Miami sites, habitat patches at the CSTARS and USCG parcels that previously supported adults seemed smaller due to increased vegetation growth, and consequently these patches appeared less suitable for the beetle than in the earlier surveys (Knisley 2015a, p. 10).

Surveys of adult numbers over the years, especially the frequent surveys in 2009, did not indicate a bimodal adult activity pattern (Knisley 2015a, p. 10). Knisley (2015a, p. 10) suggests that actual numbers of adult Miami tiger beetles could be 2 to 3 times higher than indicated by the raw index counts. Several studies comparing methods for estimating population size of several tiger beetle species, including the Highlands tiger beetle, found total numbers present were usually more than two times that indicated by the index counts (Knisley and Hill 2013, pp. 27-28). The underestimates from raw index counts are likely to be comparable or greater for the Miami tiger beetle, because of its small size and occurrence in small open patches where individuals can be obscured by vegetation around the edges, making detection especially difficult (Knisley 2015a, p. 10).

Surveys for larvae at the Zoo Miami parcel (Zoos A and B) were conducted in several years during January when lower temperatures would result in a higher level of larval activity and open burrows (Knisley and Hill 2013, p. 38) (see Table 2 in Supporting Documents on http://www.regulations.gov). The January 2010 survey produced a count of 63 larval burrows, including 5 first instars, 36 second instars, and 22 third instars (Knisley 2013, p. 4). All burrows were in the same bare sandy patches where adults were found. In March 2010, a followup survey indicated most second instar larvae had progressed to the third instar (Knisley 2015a, p. 11). Additional surveys to determine larval distribution and relative abundance during January or February in subsequent years detected fewer larvae in section Zoo B: 5 larvae in 2011, 3 larvae in 2012, 3 and 5 larvae in 2013, 3 larvae in 2014, and 15 larvae in 2015 (Knisley 2013, pp. 4-5; Knisley 2015c, p. 1). The reason for this decline in larval numbers (i.e., from 63 in 2010, to 15 or fewer in each survey year from 2011 to 2015) is unknown. Possible explanations are that fewer larvae were present because of reduced recruitment by adults from 2010 to 2014, increased difficulty in detecting larval burrows that were present due to vegetation growth and leaf litter, environmental factors (e.g., temperature, precipitation, predators), or a combination of these factors (Knisley 2015a, pp. 10-11). Larvae, like adults, also require open patches free from vegetation encroachment to complete their development. The January 2015 survey observed vegetation encroachment, as indicated by several of the numbered tags marking larval burrows in open patches in 2010 covered by plant growth and leaf litter (Knisley 2015c, p. 1). No larvae were observed in the January 2015 survey of Zoo A (Knisley 2015c, p. 1). Knisley (2015d, p. 3) reported that the area had been recently burned (mid-November) and low vegetation was absent, resulting in mostly bare ground with extensive pine needle coverage.

Surveys for the beetle's presence outside of its currently known occupied range found no Miami tiger beetles at a total of 42 sites (17 pine rockland sites and 25 scrub sites) throughout Miami-Dade, Broward, Palm Beach, and Martin Counties (Knisley 2015a, pp. 9, 41-45). The absence of the Miami tiger beetle from sites north of Miami-Dade was probably because it never ranged beyond pine rockland habitat of Miami-Dade County and into scrub habitats to the north (Knisley 2015a, p. 9). Sites without the Miami tiger beetle in Miami-Dade County mostly had vegetation that was too dense and were lacking the open patches of sandy soil that are needed by adults for oviposition and larval habitat (Knisley 2015a, pp. 9, 41-45).

The Miami tiger beetle is considered as one of two tiger beetles in the United States most in danger of extinction (Knisley et al. 2014, p. 93). The viability of the remaining population is unknown, as no population viability analysis is available (B. Knisley, 2015d, pers. comm.). The Florida Fish and Wildlife Conservation Commission (FWC) (2012, p. 89) regarded it as a species of greatest conservation need. The Miami tiger beetle is currently ranked S1 and G1 by the FNAI (2015, p. 16), meaning it is critically imperiled globally because of extreme rarity (5 or fewer occurrences, or fewer than 1,000 individuals) or because of extreme vulnerability to extinction due to some natural or manmade factor.

In summary, the overall population size of the Miami tiger beetle is exceptionally small and viability is uncertain. Based upon the index count data to date, it appears that the two populations exist in extremely low numbers (Knisley 2015a, pp. 2, 10-11, 24).

Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on any of the following five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; and (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination. Each of these factors is discussed below.

The Miami tiger beetle is threatened by habitat loss and modification caused by changes in land use and inadequate land management, including the lack of prescribed burns and vegetation (native and nonnative) encroachment (discussed separately below). Habitat loss and modification are expected to continue and increase, affecting any populations on private lands as well as those on protected lands that depend on management actions (i.e., prescribed fire) where these actions could be precluded by surrounding development.

The Miami tiger beetle has experienced substantial destruction, modification, and curtailment of its habitat and range (Brzoska et al. 2011, pp. 5-6; Knisley 2013, pp. 7-8; Knisley 2015a, p. 11). The pine rockland community of south Florida, on which the beetle depends, is critically imperiled globally (FNAI 2013, p. 3). Destruction of the pinelands for economic development has reduced this habitat by 90 percent on mainland south Florida (O'Brien 1998, p. 208). Outside of ENP, only about 1 percent of the Miami Rock Ridge pinelands have escaped clearing, and much of what is left is in small remnant blocks isolated from other natural areas (Herndon 1998, p. 1).

The two known populations of the Miami tiger beetle occur within the Richmond Pine Rocklands, on parcels of publicly or privately owned lands that are partially developed, yet retain some undeveloped pine rockland habitat. In the 1940s, the Naval Air Station Richmond was built largely on what is currently the Zoo Miami parcel. Much of the currently occupied Miami tiger beetle habitat on the Zoo Miami parcel was scraped for the creation of runways and blimp hangars (Wirth 2015, entire). The fact that this formerly scraped pine rockland area now provides suitable habitat for the Miami tiger beetle demonstrates the restoration potential of disturbed pine rockland habitat (Possley 2015, entire; Wirth 2015, entire).

Any current known or unknown, extant Miami tiger beetle populations or potentially suitable habitat that may occur on private lands or non-conservation public lands, such as elsewhere within the Richmond Pine Rocklands or surrounding pine rocklands, are vulnerable to habitat loss. Miami-Dade County leads the State in gross urban density at 15.45 people per acre (Zwick and Carr 2006, pp. 1, 13), and development and human population growth are expected to continue in the future. By 2025, Miami-Dade County is predicted to exceed a population size of over 3 million people (Zwick and Carr 2006, p. 20). This predicted economic and population growth will further increase demands for land, water, and other resources, which will undoubtedly impact the survival and recovery of the Miami tiger beetle.

Remaining habitat is at risk of additional losses and degradation. Of high and specific concern are proposed development projects within the Richmond Pine Rocklands (CBD et al. 2014, pp. 19-24). In 2013, plans for potential development on portions of the Zoo Miami and USCG parcels were announced in local newspapers (Munzenrieder 2013, entire) and subsequently advertised through other mechanisms (https://www.miamidade.gov/dpmww/SolicitationDetails.aspx?Id=Invitation%20To%20Negotiate%20(ITN) [accessed April 24, 2014]). The proposed development is to include the following: Theme park rides; a seasonally opened water park; a 400-room hotel with a Sony Music Theatre performance venue; a 30,000-ft2 (2,787-m2) retail and restaurant village; an entertainment center with movie theaters and bowling; an outdoor area for sports; a landscaped pedestrian and bike path; parking; and a 2.4-km (1.5-mi) transportation link that unifies the project's parts (Dinkova 2014a, p.1). The proposed development will require at least a portion of the USCG parcel, which would occur through purchase or a land swap (Dinkova 2014b, p. 1).

The Service notified Miami-Dade County in a December 2, 2014, letter about proposed development concerns with potential impacts to listed, candidate, and imperiled species, including the Miami tiger beetle. Plans for the proposed development on the Zoo Miami and USCG parcels have yet to be finalized, so potential impacts to the Miami tiger beetle and its habitat cannot be fully assessed. However, based upon available information provided to date, it appears that the proposed development will impact suitable or potentially suitable beetle habitat.

In July 2014, the Service became aware of another proposed development project on privately owned lands within the Richmond Pine Rocklands. In a July 15, 2014, letter to the proposed developer, the Service named the Miami tiger beetle (along with other federally listed and proposed species and habitats) as occurring within the project footprint, and expressed concern over indirect impacts (e.g., the ability to conduct prescribed fire within the Richmond Pine Rocklands). Based upon applicant plans received in May 2015, the proposed project will contain a variety of commercial, residential, and other development within approximately 138 ac (56 ha) (Ram 2015, p. 4). It is unknown if the Miami tiger beetle occurs on the proposed development site, as only one limited survey has been conducted on a small portion (approximately 1.7 ha (4.3 ac)) of the proposed development area and more surveys are needed. Based upon available information, it appears that the proposed developments will likely impact suitable or potentially suitable beetle habitat, because roughly 33 acres of the proposed development are planned for intact and degraded pine rocklands (Ram 2015, p. 91). The Service has met with the developers to learn more about their plans and address listed, candidate, and imperiled species issues; negotiations are continuing, and a draft habitat conservation plan has been developed (Ram 2015, entire).

Given the species' highly restricted range and uncertain viability, any additional losses are significant. Additional development might further limit the ability to conduct prescribed burns or other beneficial management activities that are necessary to maintain the open areas within pine rockland habitat that are required by the beetle. The pattern of public and private ownership presents an urban wildland interface, which is a known constraint for implementing prescribed fire in similar pine rockland habitats (i.e., at National Key Deer Refuge and in southern Miami-Dade County) (Snyder et al. 2005, p. 2; Service 2009, p. 50; 79 FR 47180, August 12, 2014; 79 FR 52567, September 4, 2014). The Florida Department of Forestry has limited staff in Miami-Dade County, and they have been reluctant to set fires for liability reasons (URS 2007, p. 39) (see “Land Management,” below).

In summary, given the Miami tiger beetle's highly restricted range and uncertain viability, any additional losses of habitat within its current range present substantial threats to its survival and recovery.

The threat of habitat destruction or modification is further exacerbated by a lack of adequate fire management (Brzoska et al. 2011, pp. 5-6; Knisley 2013, pp. 7-8; Knisley 2015a, p. 2). Historically, lightning-induced fires were a vital component in maintaining native vegetation within the pine rockland ecosystem, as well as for opening patches in the vegetation required by the beetles (Loope and Dunevitz 1981, p. 5; Slocum et al. 2003, p. 93; Snyder et al. 2005, p. 1; Knisley 2011a, pp. 31-32). Open patches in the landscape, which allow for ample sunlight for thermoregulation, are necessary for Miami tiger beetles to perform their normal activities, such as foraging, mating, and oviposition (Knisley 2011a, p. 32). Larvae also require these open patches to complete their development free from vegetation encroachment. Without fire, successional change from tropical pineland to hardwood hammock is rapid, and displacement of native plants by invasive, nonnative plants often occurs, resulting in vegetation overgrowth and litter accumulation in the open, bare, sandy patches that are necessary for the Miami tiger beetle. In the absence of fire, pine rockland will succeed to tropical hardwood hammock in 20 to 30 years, as thick duff layer accumulates and eventually results in the appearance of humic soils rather than mineral soils (Alexander 1967, p. 863; Wade et al. 1980, p. 92; Loope and Dunevitz 1981, p. 6; Snyder et al. 1990, p. 260).

Miami-Dade County has implemented various conservation measures, such as burning in a mosaic pattern and on a small scale, during prescribed burns, to help conserve the Miami tiger beetles and other imperiled species and their habitats (J. Maguire, 2010, pers. comm.). Miami-Dade County Parks and Recreation staff has burned several of its conservation lands on fire return intervals of approximately 3 to 7 years. However, implementation of the county's prescribed fire program has been hampered by a shortage of resources, logistical difficulties, smoke management, and public concern related to burning next to residential areas (Snyder et al. 2005, p. 2; FNAI 2010, p. 5). Many homes and other developments have been built in a mosaic of pine rockland, so the use of prescribed fire in many places has become complicated because of potential danger to structures and smoke generated from the burns. The risk of liability and limited staff in Miami-Dade County have hindered prescribed fire efforts (URS 2007, p. 39). Nonprofit organizations, such as the Institute for Regional Conservation, have faced similar challenges in conducting prescribed burns, due to difficulties with permitting and obtaining the necessary permissions, as well as hazard insurance limitations (Bradley and Gann 2008, p. 17; G. Gann, 2013, pers. comm.). Few private landowners have the means or desire to implement prescribed fire on their property, and doing so in a fragmented urban environment is logistically difficult and costly (Bradley and Gann 2008, p. 3). Lack of management has resulted in rapid habitat decline on most of the small pine rockland fragments, with the disappearance of federally listed and candidate species where they once occurred (Bradley and Gann 2008, p. 3).

Despite efforts to use prescribed fire as a management tool in pine rockland habitat, sites with the Miami tiger beetle are not burned as frequently as needed to maintain suitable beetle habitat. Most of the occupied beetle habitat at Miami-Dade County's Zoo Miami parcel was last burned in January and October of 2007; by 2010, there was noticeable vegetation encroachment into suitable habitat patches (Knisley 2011a, p. 36). The northern portion (Zoo A) of the Zoo Miami site was burned in November 2014 (Knisley 2015c, p. 3). Several occupied locations at the CSTARS parcel were burned in 2010, but four other locations at CSTARS were last burned in 2004 and 2006 (Knisley 2011a, p. 36). No recent burns are believed to have occurred at the USCG parcel (Knisley 2011a, p. 36). The decline in adult numbers at the two primary Zoo Miami patches (A and B) in 2014 surveys, and the few larvae found there in recent years, may be a result of the observed loss of bare open patches (Knisley 2015a, p. 12; Knisley 2015c, pp. 1-3). Surveys of the CSTARS and USCG parcels in 2014 found similar loss of open patches from encroaching vegetation (Knisley 2015a, p. 13).

Alternatives to prescribed fire, such as mechanical removal of woody vegetation are not as ecologically effective as fire. Mechanical treatments do not replicate fire's ability to recycle nutrients to the soil, a process that is critical to many pine rockland species (URS 2007, p. 39). To prevent organic soils from developing, uprooted woody debris requires removal, which adds to the required labor. The use of mechanical equipment can also damage soils and inadvertently include the removal or trampling of other non-target species or critical habitat (URS 2007, p. 39).

Nonnative plants have significantly affected pine rocklands (Bradley and Gann 1999, pp. 15, 72; Bradley and Gann 2005, page numbers not applicable; Bradley and van der Heiden 2013, pp. 12-16). As a result of human activities, at least 277 taxa of nonnative plants have invaded pine rocklands throughout south Florida (Service 1999, p. 3-175). Neyraudia neyraudiana (Burma reed) and Schinus terebinthifolius (Brazilian pepper), which have the ability to rapidly invade open areas, threaten the habitat needs of the Miami tiger beetle (Bradley and Gann 1999, pp. 13, 72). S. terebinthifolius, a nonnative tree, is the most widespread and one of the most invasive species. It forms dense thickets of tangled, woody stems that completely shade out and displace native vegetation (Loflin 1991, p. 19; Langeland and Craddock Burks 1998, p. 54). Acacia auriculiformis (earleaf acacia), Melinis repens (natal grass), Lantana camara (shrub verbena), and Albizia lebbeck (tongue tree) are some of the other nonnative species in pine rocklands. More species of nonnative plants could become problems in the future, such as Lygodium microphyllum (Old World climbing fern), which is a serious threat throughout south Florida.

Nonnative, invasive plants compete with native plants for space, light, water, and nutrients, and make habitat conditions unsuitable for the Miami tiger beetle, which responds positively to open conditions. Invasive nonnatives also affect the characteristics of a fire when it does occur. Historically, pine rocklands had an open, low understory where natural fires remained patchy with low temperature intensity. Dense infestations of Neyraudia neyraudiana and Schinus terebinthifolius cause higher fire temperatures and longer burning periods. With the presence of invasive, nonnative species, it is uncertain how fire, even under a managed situation, will affect habitat conditions or Miami tiger beetles.

Management of nonnative, invasive plants in pine rocklands in Miami-Dade County is further complicated because the vast majority of pine rocklands are small, fragmented areas bordered by urban development. Fragmentation results in an increased proportion of “edge” habitat, which in turn has a variety of effects, including changes in microclimate and community structure at various distances from the edge (Margules and Pressey 2000, p. 248); altered spatial distribution of fire (greater fire frequency in areas nearer the edge) (Cochrane 2001, pp. 1518-1519); and increased pressure from nonnative, invasive plants and animals that may out-compete or disturb native plant populations. Additionally, areas near managed pine rockland that contains nonnative species can act as a seed source of nonnatives, allowing them to continue to invade the surrounding pine rockland (Bradley and Gann 1999, p. 13).

In 2005, the Service funded the Institute for Regional Conservation (IRC) to facilitate restoration and management of privately owned pine rockland habitats in Miami-Dade County. This initiative included prescribed burns, nonnative plant control, light debris removal, hardwood management, reintroduction of pines where needed, and development of management plans. The Pine Rockland Initiative includes 10-year cooperative agreements between participating landowners and the Service/IRC to ensure restored areas will be managed appropriately during that time. Although most of these objectives regarding nonnative plant control, creation of fire breaks, removal of excessive fuel loads, and management plans have been achieved, IRC has not been able to conduct the desired prescribed burns, due to logistical difficulties as discussed above (see “Land Management”). IRC has recently resolved some of the challenges regarding contractor availability for prescribed burns and the Service has extended IRC's funding period through August 2016. Results from anticipated fire management restoration activities will be available in the fall of 2016.

Fairchild Tropical Botanic Garden (FTBG), with the support of various Federal, State, local, and nonprofit organizations, has established the “Connect to Protect Network.” The objective of this program is to encourage widespread participation of citizens to create corridors of healthy pine rocklands by planting stepping stone gardens and rights-of-way with native pine rockland species, and restoring isolated pine rockland fragments. Although these projects may serve as valuable components toward the conservation of pine rockland species and habitat, they are dependent on continual funding, as well as participation from private landowners, both of which may vary through time.

We have identified a number of threats to the habitat of the Miami tiger beetle, which have occurred in the past, are impacting the species now, and will continue to impact the species in the future. Habitat loss, fragmentation, and degradation, and associated pressures from increased human population, are major threats; these threats are expected to continue, placing the species at greater risk. The species' occurrence on pine rocklands that are partially protected from development (see “Local” under Factor D, below) tempers some impacts, yet the threat of further loss and fragmentation of habitat remains. Various conservation programs are in place, and while these help to reduce some threats of habitat loss and modification, these programs are limited in nature. In general, available resources and land management activities (e.g., prescribed fire and invasive plant control) on public and private lands are inadequate to prevent modification and degradation of the species' habitat. Therefore, based on our analysis of the best available information, the present and future loss and modification of the species' habitat are major threats to the Miami tiger beetle throughout its range.

Rare beetles, butterflies, and moths are highly prized by collectors. Tiger beetles are the subject of more intense collecting and study than any other single beetle group (Pearson 1988, pp. 123-124; Knisley and Hill 1992a, p. 9; Choate 1996, p. 1; Knisley et al. 2014, p. 94). Interest in the genus Cicindela (and Cicindelidia) is reflected in a journal entitled “Cicindela,” which has been published quarterly since 1969 and is exclusively devoted to the genus. Tiger beetle collecting and the sale and trade of specimens have increased in popularity in recent years (Knisley et al. 2014, p. 138). Among the professional researchers and many amateurs that collect tiger beetles are individuals that take only small numbers; however, there are also avid collectors who take as many specimens as possible, often for sale or trade. At present, it is estimated that nationally 50 to 100 individuals collect tiger beetles, and approximately 50 individuals are avid collectors (Knisley 2015b, p. 14). Knowledge of and communication with many of these collectors suggest sale and trading of specimens has become much more common in recent years. The increased interest in collecting, along with photographing specimens, seems to have been stimulated in part due to the publication of the tiger beetle field guide (Pearson et al. 2006, entire). Collectors are especially interested in the less common forms, and may have little regard for their conservation (Knisley 2015b, p. 14). There is ample evidence of collectors impacting imperiled and endangered butterflies (Gochfeld and Burger 1997, pp. 208- 209) and even contributing to extirpations (Duffey 1968, p. 94). For example, the federally endangered Mitchell's satyr (Neonympha mitchellii mitchellii) is believed to have been extirpated from New Jersey due to overcollecting (57 FR 21567, May 20, 1992; Gochfeld and Burger 1997, p. 209).

Collection is serious threat to the Miami tiger beetle due to extreme rarity (a factor that increases demand by collectors) and vulnerability (i.e., uncertain status and viability with just two known populations and few individuals). Collection is especially problematic if adults are taken prior to oviposition or from small, isolated, or poor-quality sites. Because no large, high-quality sites are currently known, any collection can have serious ramifications on the survival of the remaining population(s).

The recent description of the species did not disclose the exact locations of occurrence, due to concerns with collection (Brzoska et al. 2011, p. 5); however, it is now believed that occurrences at Zoo Miami, USCG, and CSTARS in the Richmond population are fairly well known, especially in the tiger beetle collecting community (B. Knisley, 2014b, pers. comm.). We have no specific information on the collection pressure for the Miami tiger beetle, but it is expected to be high based upon what has transpired in comparable situations with other federally listed and imperiled tiger beetles and butterflies both nationwide and in Florida. For example, the federally endangered Ohlone tiger beetle (Cicindela ohlone) was collected from its type locality in California after its description in the scientific literature (66 FR 50340, October 3, 2001) (Knisley 2015a, p. 14). Similarly, overcollection of the Highlands tiger beetle may have contributed to the extirpation of that species from its type locality in Florida (Knisley and Hill 1992a, p. 9). An estimated 500 to 1,000 adult Highlands tiger beetles had been collected at this site during a several year period after its initial discovery (Knisley and Hill 1992a, p. 10).

Markets currently exist for tiger beetles. Specimens of two Florida tiger beetles, the Highlands tiger beetle, a federal candidate species, and the scrub tiger beetle are regularly offered for sale or trade through online insect dealers (The Bugmaniac 2015 and eBay 2015). Considering the recent rediscovery of the Miami tiger beetle and concerns regarding its continued existence, the desirability of this species to private collectors is expected to increase, which may lead to similar markets and increased demand.

Another reason it is not possible to assess actual impacts from collection is that known occurrences of the Miami tiger beetle are not regularly monitored. Two known occurrences on the USCG and CSTARS parcels are gated and accessible only by permit, so collection from these sites is unlikely unless authorized by the property owners. However, other occupied and potential habitats at neighboring and surrounding areas are much more accessible. Risk of collection is concerning at any location and is more likely at less secure sites. Collection potential at Zoo Miami and other accessible sites is high, in part because it is not entirely gated and only periodically patrolled (B. Knisley, 2014b, pers. comm.). Most of the remaining pine rockland habitat outside of ENP in Miami Dade County is owned by the County or in private ownership and not regularly monitored or patrolled.

We consider collection to be a significant threat to the Miami tiger beetle in light of the few known remaining populations, low abundance, and highly restricted range. Even limited collection from the remaining populations could have deleterious effects on reproductive and genetic viability of the species and could contribute to its extinction. Removal of adults early in the flight season or prior to oviposition can be particularly damaging, as it further reduces potential for successful reproduction. A population may be reduced to below sustainable numbers (Allee effect) by removal of females, reducing the probability that new occurrences will be founded. Small and isolated occurrences in poor habitat may be at greatest risk (see Factor E discussion, below) as these might not be able to withstand additional losses. Collectors may be unable to recognize when they are depleting occurrences below the thresholds of survival or recovery (Collins and Morris 1985, pp. 162-165).

With regard to scientific research, we do not believe that general techniques used to date have had negative impacts on the species or its habitat. Visual index surveys and netting for identification purposes have been performed during scientific research and conservation efforts with the potential to disturb or injure individuals or damage habitat. Limited collection as part of laboratory rearing studies or taxonomic verification has occurred at some sites, with work authorized by permits. Based on the extreme rarity of the species, various collecting techniques (e.g., pitfall traps, Malaise traps, light traps) for other more general insect research projects should be considered a potential threat.

Collection interest in tiger beetles, especially rare species, is high, and markets currently exist. While it is not possible to quantify the impacts of collection on the Miami tiger beetle, collection of the Highlands tiger beetle has been documented in large numbers, and collection is currently occurring. The risk of collection of the Miami tiger beetle from both occupied and other potential habitat is high, as some sites are generally accessible and not monitored or patrolled. Due to the few remaining populations, low abundance, and restricted range, we have determined that collection is a significant threat to the species and could potentially occur at any time. Even limited collection from the remaining populations could have negative effects on reproductive and genetic viability of the species and could contribute to its extinction.

There is no evidence of disease or pathogens affecting the Miami tiger beetle, although this threat has not been investigated. Parasites and predators, however, have been found to have significant impacts on adult and larval tiger beetles. In general, parasites are considered to have greater effects on tiger beetles than predators (Nagano 1982, p. 34; Pearson 1988, pp. 136-138). While parasites and predators play important roles in the natural dynamics of tiger beetle populations, the current small size of the Miami tiger beetle populations may render the species more vulnerable to parasitism and predation than historically, when the species was more widely distributed and therefore more resilient.

Known predators of adult tiger beetles include birds, lizards, spiders, and especially robber flies (family Asilidae) (Pearson et al. 2006, p. 183). Researchers and collectors have often observed robber flies in the field capturing tiger beetles out of the air. Pearson (1985, pp. 68-69; 1988, p. 134) found tiger beetles with orange abdomens (warning coloration) were preyed upon less frequently than similar-sized tiger beetles without the orange abdomens. His field trials also determined that size alone provided some protection from robber flies, which are usually only successful in killing prey that is smaller than they are. This was the case with the hairy-necked tiger beetle (Cicindela hirticollis) being attacked at a significantly higher rate than the larger northeastern beach tiger beetle in Maryland (Knisley and Hill 2010, pp. 54-55). On the basis of these field studies, it was estimated that robber flies may cause over 50 percent mortality to the hairy-necked tiger beetle and 6 percent to the northeastern beach tiger beetle population throughout the flight season (Knisley and Hill 2010, pp. 54-55). The small body size of the Miami tiger beetle, even with its orange abdomen, suggests it would be susceptible to robber fly attack. No robber flies have been observed during the limited field studies on the Miami tiger beetle; however, they are a common predator of the closely related Highlands tiger beetle (Knisley and Hill 2013, p. 40). In 24 hours of field study, Knisley and Hill (2013, p. 40) observed 22 attacks by robber flies on Highlands tiger beetles, 5 of which resulted in the robber fly killing and consuming the adult beetles.

Most predators of adult tiger beetles are opportunistic, feeding on a variety of available prey, and therefore probably have only a limited impact on tiger beetle populations. However, predators, and especially parasites, of larvae are more common and some attack only tiger beetles. Ants are regarded as important predators on tiger beetles, and although not well studied, they have been reported having significant impact on first instar larvae of some Arizona tiger beetles (Cicindela spp.) (Knisley and Juliano 1988, p. 1990). A study with the Highlands tiger beetle found ants accounted for 11 to 17 percent of larval mortality at several sites, primarily involving first instars (Knisley and Hill 2013, p. 37). During surveys for the Miami tiger beetle, various species of ants were commonly seen co-occurring in the sandy patches with adults and larvae, but their impact, if any, is unknown at this time.

Available literature indicates that the most important tiger beetle natural enemies are tiphiid wasps and bombyliid flies, which parasitize larvae (Knisley and Schultz 1997, pp. 53-57). The wasps enter the larvae burrows, and paralyze and lay an egg on the larvae. The resulting parasite larva consumes the host tiger beetle larva. Bombyliid flies (genus Anthrax) drop eggs into larval burrows with the resulting fly larvae consuming the tiger beetle larva. These parasitoids accounted for 20 to 80 percent mortality in larvae of several northeastern tiger beetles (Pearson and Vogler 2001, p. 172). Parasitism from bombyliid flies accounted for 13 to 25 percent mortality to larvae of the Highlands tiger beetle at several sites (Knisley and Hill 2013, p. 37). Generally, these rates of parasitism are similar to those reported for other species of tiger beetles (Bram and Knisley 1982, p. 99; Palmer 1982, p. 64; Knisley 1987, p. 1198). No tiphiid wasps or bombyliid flies were observed during field studies with the Miami tiger beetle (Knisley 2015a, p. 15); however, tiphiid wasps are small, secretive, and evidence of their attacks is difficult to find (Knisley 2015b, p. 16).

Potential impacts from predators or parasites to the Miami tiger beetle are unknown. Given the small size of the Miami tiger beetle's two populations, the species is likely vulnerable to predation and parasitism.

Section 4(b)(1)(A) of the Act requires the Service to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species. . . .” In relation to Factor D, we interpret this language to require the Service to consider relevant Federal, State, and Tribal laws, plans, regulations, and other such mechanisms that may minimize any of the threats we describe in threat analyses under the other four factors, or otherwise enhance conservation of the species. We give strongest weight to statutes and their implementing regulations and to management direction that stems from those laws and regulations. An example would be State governmental actions enforced under a State statute or constitution, or Federal action under statute.

The Miami tiger beetle currently has no Federal protective status and has limited regulatory protection in its known occupied and suitable habitat. The species is not known to occur on National Wildlife Refuge or National Park land. The Miami tiger beetle is known to occur on USCG lands within the Richmond Pinelands Complex, and there are limited protection for the species on this property; any USCG actions or decisions that may have an effect on the environment would require consideration and review under the National Environmental Policy Act (NEPA) (42 U.S.C. 4321 et seq.). No Federal permit or other authorization is currently needed for potential impacts to known occurrences on county-owned and private land. The Miami tiger beetle could be afforded limited protections from sections 7 and 10 of the Act based on its co-occurrence with listed species or their critical habitat, if applicable, within the Richmond Pine Rocklands, including species such as the Bartram's scrub-hairstreak butterfly (Strymon acis bartrami), Florida leafwing butterfly (Anaea troglodyta floridalis), Florida bonneted bat (Eumops floridanus), Florida brickell-bush (Brickellia mosieri), Carter's small-flowered flax (Linum carteri var. carteri), deltoid spurge (Chamaesyce deltoidea ssp. deltoidea), and tiny polygala (Polygala smallii). However, effect determinations and minimization and avoidance criteria for any of these listed species are unlikely to be fully protective to the Miami tiger beetle considering its extreme rarity. The listed species have broader distributions that allow for more flexibility with appropriate conservation measures. In contrast, with only two known populations and few remaining adults, the Miami tiger beetle has a much lower threat tolerance. Although the beetle is not currently federally protected, the Service has met with Miami-Dade County, the USCG, the University of Miami, and potential developers to express our concern regarding listed, proposed, candidate, and imperiled species in the Richmond Pine Rocklands, including the Miami tiger beetle. We have recommended that management and habitat conservation plans include and fully consider this species and its habitat.

The Miami tiger beetle is not currently listed as endangered or threatened by the State of Florida, so there are no existing regulations designated to protect it. The Miami tiger beetle is recognized as a species of greatest conservation need by the FWC (FWC 2012, p. 89). Species of greatest conservation need designation is part of the State's strategy to recognize and seek funding opportunities for research and conservation of these species, particularly through the State Wildlife Grants program. The list is extensive and, to date, we are unaware of any dedicated funding from this program for the beetle. The Miami tiger beetle is not known to occur on lands owned by the State of Florida; however, not all State-owned pine rockland parcels have been adequately surveyed. It is possible that some State-owned parcels do provide potentially suitable habitat, and support occurrences of, the Miami tiger beetle.

In 1984, section 24-49 of the Code of Miami-Dade County established regulation of County-designated Natural Forested Communities (NFCs), which include both pine rocklands and tropical hardwood hammocks. These regulations were placed on specific properties throughout the county by an act of the Board of County Commissioners in an effort to protect environmentally sensitive forest lands. The Miami-Dade County Department of Regulatory and Economic Resources (RER) has regulatory authority over NFCs, and is charged with enforcing regulations that provide partial protection on the Miami Rock Ridge. Miami-Dade Code typically allows up to 20 percent of a pine rockland designated as NFC to be developed, and requires that the remaining 80 percent be placed under a perpetual covenant. In certain circumstances, where the landowner can demonstrate that limiting development to 20 percent does not allow for “reasonable use” of the property, additional development may be approved. NFC landowners are also required to obtain an NFC permit for any work within the boundaries of the NFC on their property. The NFC program is responsible for ensuring that NFC permits are issued in accordance with the limitations and requirements of the code and that appropriate NFC preserves are established and maintained in conjunction with the issuance of an NFC permit. The NFC program currently regulates approximately 600 pine rockland or pine rockland/hammock properties, comprising approximately 1,200 ha (3,000 ac) of habitat (J. Joyner, 2013, pers. comm.). When RER discovers unpermitted activities, it takes appropriate enforcement action, and seeks restoration when possible. Because these regulations allows for development of pine rockland habitat, and because unpermitted development and destruction of pine rockland continues to occur, the regulations are not fully effective at protecting against loss of Miami tiger beetles or their potential habitat.

Under Miami-Dade County ordinance (section 26-1), a permit is required to conduct scientific research (rule 9) on county environmental lands. In addition, rule 8 of this ordinance provides for the preservation of habitat within County parks or areas operated by the Parks and Recreation Department. The scientific research permitting effectively allows the County to monitor and manage the level of scientific research and collection of the Miami tiger beetle, and the preservation of pine rockland habitat benefits the beetle.

Fee Title Properties: In 1990, Miami-Dade County voters approved a 2-year property tax to fund the acquisition, protection, and maintenance of environmentally endangered lands (EEL). The EEL Program identifies and secures these lands for preservation. Under this program to date, Miami-Dade County has acquired a total of approximately 255 ha (630 ac) of pine rocklands. In addition, approximately 445 ha (1,100 ac) of pine rocklands are owned by the Miami-Dade County Parks and Recreation Department and managed by the EEL Program, including some of the largest remaining areas of pine rockland habitat on the Miami Rock Ridge outside of ENP (e.g., Larry and Penny Thompson Park, Zoo Miami pinelands, and Navy Wells Pineland Preserve).

There are some regulatory mechanisms currently in place to protect the Miami tiger beetle and its habitat on non-Federal lands. However, there are no Federal regulatory protections for the Miami tiger beetle, other than the limited protections afforded for listed species and critical habitat that co-occur with the Miami tiger beetle. While local regulations provide some protection, they are generally not fully effective (e.g., NFC regulations allow development of 20 percent or more of pine rockland habitat) or implemented sufficiently (e.g., unpermitted clearing of pine rockland habitat) to alleviate threats to the Miami tiger beetle and its habitat. The degradation of habitat for the Miami tiger beetle is ongoing despite existing regulatory mechanisms. Based on our analysis of the best available information, we find that existing regulatory measures, due to a variety of constraints, are inadequate to fully address threats to the species throughout its range.

The Miami tiger beetle is vulnerable to extinction due to its severely reduced range, the fact that only two small populations remain, and the species' relative isolation.

Demographic stochasticity refers to random variability in survival or reproduction among individuals within a population (Shaffer 1981, p. 131). Demographic stochasticity can have a significant impact on population viability for populations that are small, have low fecundity, and are short-lived. In small populations, reduced reproduction or die-offs of a certain age-class will have a significant effect on the whole population. Although of only minor consequence to large populations, this randomly occurring variation in individuals becomes an important issue for small populations.

Environmental stochasticity is the variation in birth and death rates from one season to the next in response to weather, disease, competition, predation, or other factors external to the population (Shaffer 1981, p. 131). For example, drought or predation, in combination with a low population year, could result in extirpation. The origin of the environmental stochastic event can be natural or human-caused.

In general, tiger beetles that have been regularly monitored consistently exhibit extreme fluctuations in population size, often apparently due to climatic or other habitat factors that affect recruitment, population growth, and other population parameters. In 20 or more years of monitoring, most populations of the northeastern beach and puritan tiger beetles (Cicindela puritan) have exhibited 2 to 5 or more fold differences in abundance (Knisley 2012, entire). Annual population estimates of the Coral Pink Sand Dunes tiger beetle (Cicindela albissima) (have ranged from fewer than 600 to nearly 3,000 adults over a 22-year period (Gowan and Knisley 2014, p. 124). The Miami tiger beetle has not been monitored as extensively as these species, but in areas where Miami tiger beetles were repeatedly surveyed, researchers found fluctuations that were several fold in numbers (Knisley 2015a, p. 24). While these fluctuations appear to be the norm for populations of tiger beetles (and most insects), the causes and effects are not well known. Among the suggested causes of these population trends are annual rainfall patterns for the Coral Pink Sand Dunes tiger beetle (Knisley and Hill 2001, p. 391; Gowan and Knisley 2014, p. 119), and shoreline erosion from storms for the northeastern beach and puritan tiger beetles (Knisley 2011b, p. 54). As a result of these fluctuations, many tiger beetle populations will experience episodic low numbers (bottlenecks) or even local extinction from genetic decline, the Allee effect, or other factors. Given that the Miami tiger beetle is only known from two remaining populations with few adult individuals, any significant decrease in the population size could easily result in extinction of the species.

Dispersal and movement of the Miami tiger beetle is unknown, but is considered to be very limited. A limited mark-recapture study with the closely related Highlands tiger beetle found that adult beetles moved no more than 150 m (490 ft), usually flying only 5-10 m (16-33 ft) at a time (Knisley and Hill 2013). Generally, tiger beetles are known to easily move around, so exchange of individuals among separated sites will commonly occur if there are habitat connections or if the sites are within dispersal range—which is not the case with the population structure of the Miami tiger beetle. Species in woodland, scrub, or dune habitats also seem to disperse less than water-edge species (Knisley and Hill 1996, p. 13). Among tiger beetles, there is a general trend of decreasing flight distance with decreasing body size (Knisley and Hill 1996, p. 13). The Miami tiger beetle has a small body size. Given these factors, dispersal may be limited for the Miami tiger beetle.

Small, isolated population size was listed as one of several of the threats in the petition received to list the Miami tiger beetle (CBD et. al. 2014, pp. 17, 30). The effects of low population size on population viability are not known for tiger beetles, but population viability analyses for the northeastern beach, puritan, and Coral Pink Sand Dunes tiger beetles determined that stochasticity, specifically the fluctuations in population size, was the main factor accounting for the high risk of extinction (Gowan and Knisley 2001, entire; 2005, p. 13; Knisley and Gowan 2009, pp. 13-23). The long-term monitoring of northeastern beach and puritan tiger beetles found that, despite the fluctuations, some small populations with fewer than 50 to 100 adults experienced several fold declines, but persisted (Knisley 2015b, p. 20). Several Highlands tiger beetle sites with fewer than 20 to 50 adults were lost over the past 15-20 years, while several others have persisted during that period (Knisley 2015b, p. 20). Losses may have been due to habitat disturbance or low population size effects. Knisley predicts that the Highlands tiger beetle populations (extinct and extant) are isolated from each other with little chance for dispersal between populations and immigration rescues (B. Knisley, 2015d, pers. comm.). With only two known populations of the Miami tiger beetle, separated by substantial urban development, the potential for immigration rescue is low.

Pesticides used in and around pine rockland habitat are a potential threat to the Miami tiger beetle through direct exposure to adults and larvae, secondary exposure from insect prey, overall reduction in availability of adult and larval prey, or any combination of these factors. The use of pesticides for agriculture and mosquito control presents potential risks to nontarget insects, especially imperiled insects (EPA 2002, p. 32; 2006a, p. 58; 2006b, p. 44). The negative effect of insecticides on several tiger beetle species was suggested by Nagano (1980, p. 34) and Stamatov (1972, p. 78), although impacts from pesticides do not appear to be well studied in tiger beetles.

Efforts to control mosquitoes and other insect pests in Florida have increased as human activity and population size have increased. To control mosquito populations, organophosphate (naled) and pyrethroid (permethrin) adulticides are applied by mosquito control districts throughout south Florida, including Miami-Dade County. These compounds have been characterized as being highly toxic to nontarget insects by the U.S. Environmental Protection Agency (2002, p. 32; 2006a, p. 58; 2006b, p. 44). The use of such pesticides (applied using both aerial and ground-based methods) for mosquito control presents a potential risk to the Miami tiger beetle.

In order for mosquito control pesticides to be effective, they must make direct contact with mosquitoes. For this to happen, pesticides are applied using methods to promote drift through the air, so as to increase the potential for contact with their intended target organism. Truck-based permethrin application methods are expected to produce a swath of suspended pesticides approximately 91 m (300 ft) wide (Prentiss 2007, p. 4). The extent of pesticide drift from this swath is dependent on several factors, including wind speed, wind direction, and vegetation density. Hennessey and Habeck (1989, pp. 1-22; 1991, pp. 1-68) and Hennessey et al. (1992, pp. 715-721) illustrated the presence of mosquito spray residues long after application in habitat of the federally endangered Schaus swallowtail butterfly (Papilio aristodemus ponceanus), as well as the Florida leafwing butterfly (Anaea troglodyta floridalis), Bartram's scrub-hairstreak butterfly, and other imperiled species. Residues of aerially applied naled were found 6 hours after application in a pineland area that was 750 m (2,460 ft) from the target area; residues of fenthion (an adulticide previously used in the Florida Keys) applied via truck were found up to 50 m (160 ft) downwind in a hammock area 15 minutes after application in adjacent target areas (Hennessey et al. 1992, pp. 715-721).

More recently, Pierce (2009, pp. 1-17) monitored naled and permethrin deposition following mosquito control application. Permethrin, applied by truck, was found to drift considerable distances from target areas, with residues that persisted for weeks. Permethrin was detected at concentrations lethal to three butterfly species at a distance of approximately 227 m (745 ft) away from targeted truck routes. Naled, applied by plane, was also found to drift into nontarget areas, but was much less persistent, exhibiting a half-life (time for half of the naled applied to chemically break down) of approximately 6 hours. To expand this work, Pierce (2011, pp. 6-11) conducted an additional deposition study in 2010, focusing on permethrin drift from truck spraying, and again documented low but measurable amounts of permethrin in nontarget areas. In 2009, Bargar (2012, p. 3) conducted two field trials that detected significant naled residues at locations within nontarget areas up to 366 m (1,200 ft) from the edge of zones targeted for aerial applications. After this discovery, the Florida Keys Mosquito Control District recalibrated the on-board model (Wingman, which provides flight guidance and flow rates). Naled deposition was reduced in some of the nontarget zones following recalibration (Bargar 2012, p. 3).

In addition to mosquito control chemicals entering nontarget areas, the toxic effects of such chemicals to nontarget organisms have also been documented. Lethal effects on nontarget moths and butterflies have been attributed to fenthion and naled in both south Florida and the Florida Keys (Emmel 1991, pp. 12-13; Eliazar and Emmel 1991, pp. 18-19; Eliazar 1992, pp. 29-30). Zhong et al. (2010, pp. 1961-1972) investigated the impact of single aerial applications of naled on the endangered Miami blue butterfly (Cyclargus thomasi bethunebakeri) larvae in the field. Survival of butterfly larvae in the target zone was 73.9 percent, which was significantly lower than in both the drift zone (90.6 percent) and the reference (control) zone (100 percent), indicating that direct exposure to naled poses significant risk to Miami blue butterfly larvae. Fifty percent of the samples in the drift zone also exhibited detectable concentrations, once again exhibiting the potential for mosquito control chemicals to drift into nontarget areas. Bargar (2012, p. 4) observed cholinesterase activity depression, to a level shown to cause mortality in the laboratory, in great southern white (Ascia monuste) and Gulf fritillary butterflies (Agraulis vanillae) exposed to naled in both target and nontarget zones.

Based on these studies, it can be concluded that mosquito control activities that involve the use of both aerial and ground-based spraying methods have the potential to deliver pesticides in quantities sufficient to cause adverse effects to nontarget species in both target and nontarget areas. Pesticide drift at a level of concern to nontarget invertebrates (butterflies) has been measured up to approximately 227 m (745 ft) from truck routes (Pierce 2011, pp. 3-5, 7; Rand and Hoang 2010, pp. 14, 23) and 400 m (1,312 ft) from aerial spray zones (Bargar 2012, p. 3). It should be noted that many of the studies referenced above dealt with single application scenarios and examined effects on only one or two butterfly life stages. Under a realistic scenario, the potential exists for exposure to all life stages to occur over multiple applications in a season. In the case of a persistent compound like permethrin, whose residues remain on vegetation for weeks, the potential exists for nontarget species to be exposed to multiple pesticides within a season (e.g., permethrin on vegetation coupled with aerial exposure to naled).

Prior to 2015, aerial applications of mosquito control pesticides occurred on a limited basis (approximately two to four aerial applications per year since 2010) within some of Miami-Dade County's pine rockland areas. The Miami tiger beetle is not known to occupy any of these aerial spray zone sites, but any unknown occupied sites could have been exposed, either directly or through drift. The Richmond Pine Rocklands region is not directly treated either aerially or by truck (C. Vasquez, 2013, pers. comm.), so any potential pesticide exposure in this area would be through drift from spray zones adjacent to the Richmond area. Pesticide drift from aerial spray zones to the two known populations of Miami tiger beetles is unlikely, based on the considerable distance from spray zone boundaries to known occurrences of the beetle (estimated minimum distances range from 2.0-3.0 km (1.2-1.9 mi) from the Richmond population and 434 m (0.3 mi) for the second population). In the past, truck-based applications occurred within 227 m (745 ft) of known occupied Miami tiger beetle habitat, a distance under which pesticide drift at a concentration of concern for nontarget invertebrates had been measured (Pierce 2011, pp. 3-5, 7; Rand and Hoang 2010, pp. 14, 23). For the 2015 mosquito season (May through October), Miami-Dade Mosquito Control coordinated with the Service to institute 250-m truck-based and 400-m aerial spray buffers around critical habitat for the Bartram's scrub-hairstreak butterfly, with the exclusion of pine rocklands in the Navy Wells area, which is not known to be occupied by the Miami tiger beetle. These newly implemented buffers will also reduce exposure to any other imperiled species occurring on pine rockland habitat within Bartram's scrub-hairstreak butterfly critical habitat, such as the Miami tiger beetle. Assuming that the Miami tiger beetle is no more sensitive to pesticide exposure than the tested butterfly species, these spray buffers should avoid adverse impacts to the Miami tiger beetle population.

Based on Miami-Dade Mosquito Control's implementation of spray buffers, mosquito control pesticides are not considered a major threat for the Miami tiger beetle at this time. If these buffers were to change or Miami tiger beetles were found to occur on habitat that is not protected by Bartram's scrub-hairstreak butterfly critical habitat, then the threat of pesticide exposure would have to be reevaluated.

Human disturbance, depending upon type and frequency, may or may not be a threat to tiger beetles or their habitats. Knisley (2011b, entire) reviewed both the negative and positive effects of human disturbances on tiger beetles. Vehicles, bicycles, and human foot traffic have been implicated in the decline and extirpation of tiger beetle populations, especially for species in more open habitats like beaches and sand dunes. The northeastern beach tiger beetle was extirpated throughout the northeast coincidental with the development of recreational use from pedestrian foot traffic and vehicles (Knisley et al. 1987, p. 301). Habroscelimorpha dorsalis media (southeastern beach tiger beetle) was extirpated from a large section of Assateague Island National Seashore, Maryland, after the initiation of off- highway vehicle (OHV) use (Knisley and Hill, 1992b, p. 134). Direct mortality and indirect effects on habitat from OHVs have been found to threaten the survival of Coral Pink Sand Dunes tiger beetle (Gowan and Knisley 2014, pp. 127-128). However, there are other documented cases of the beneficial effects of these types of disturbances, by creating open areas of habitat for tiger beetles, particularly at sites where vegetation growth has eliminated these open habitat patches (Knisley 2011, pp. 44-45). The Ohlone tiger beetle has been eliminated from nearly all natural grassland areas in Santa Cruz, California, except where pedestrian foot traffic, mountain bike use, or cattle grazing has created or maintained trails and open patches of habitat (Knisley and Arnold 2013, p. 578). Similarly, over 20 species of tiger beetles, including Cicindela decemnotata (Badlands tiger beetle) at Dugway Proving Ground in Utah, are almost exclusively restricted to roads, trails, and similar areas kept open by vehicle use or similar human disturbances (Knisley 2011b, pp. 44-45).

Vehicle activity on seldom-used roads may have some negative effect on the Miami tiger beetle (i.e., lethal impacts to adults or larvae or impacts to the habitat), but limited field observations to date indicate that effects are minimal (Knisley 2015a, p. 16). Observations in 2014 at Zoo Miami found a few adults along a little-used road and the main gravel road adjacent to interior patches where adults were more common (Knisley 2015, p. 16). These adults may have dispersed from their primary interior habitat, possibly due to vegetation encroachment (Knisley 2015a, p. 16). Several of the adults at both CSTARS and the USCG parcels were also found along dirt roads that were not heavily used and apparently provided suitable habitat.

The parcels that comprise the two known populations of the Miami tiger beetle are not open to the public for recreational use, so human disturbance is unlikely. For any unknown occurrences of the species, human disturbance from recreational use is a possibility, as some of the remaining pine rockland sites in Miami-Dade County are open to the public for recreational use. Miami-Dade County leads the State in gross urban density at 15.45 people per acre (Zwick and Carr 2006, pp. 1, 13), and development and human population growth are expected to continue in the future. By 2025, Miami-Dade County is predicted to exceed a population size of over 3 million people (Zwick and Carr 2006, p. 20). With the expected future increase in human population and development, there will likely be an increase in the use of recreational areas, including sites with potentially suitable habitat and unknown occurrences of Miami tiger beetles. Projected future increases in recreational use, may increase levels of human disturbance and negatively impact any unknown occurrences of the Miami tiger beetle and their habitat.

In summary, vehicular activity and recreational use within the known population of the Miami tiger beetle presents minimal impacts to the species. However, future negative impacts to unknown beetle occurrences on lands open to the public are possible and are expected to increase with the projected future population growth.

Climatic changes, including sea level rise (SLR), are major threats to Florida, and could impact the Miami tiger beetle and the few remaining parcels of pine rockland habitat left in Miami-Dade County. Our analyses include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). “Climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (IPCC 2007a, p. 78). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (e.g., temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to natural variability, human activity, or both (IPCC 2007a, p. 78).

Scientific measurements spanning several decades demonstrate that changes in climate are occurring, and that the rate of change has been faster since the 1950s. Based on extensive analyses of global average surface air temperature, the most widely used measure of change, the IPCC concluded that warming of the global climate system over the past several decades is “unequivocal” (IPCC 2007a, p. 2). In other words, the IPCC concluded that there is no question that the world's climate system is warming. Examples of other changes include substantial increases in precipitation in some regions of the world and decreases in other regions (for these and additional examples, see IPCC 2007a, p. 30; Solomon et al. 2007, pp. 35-54, 82-85). Various environmental changes (e.g., shifts in the ranges of plant and animal species, increasing ground instability in permafrost regions, conditions more favorable to the spread of invasive species and of some diseases, changes in amount and timing of water availability) are occurring in association with changes in climate (see IPCC 2007a, pp. 2-4, 30-33; Global Climate Change Impacts in the United States 2009, pp. 27, 79-88).

Results of scientific analyses presented by the IPCC show that most of the observed increase in global average temperature since the mid-20th century cannot be explained by natural variability in climate, and is “very likely” (defined by the IPCC as 90 percent or higher probability) due to the observed increase in greenhouse gas (GHG) concentrations in the atmosphere as a result of human activities, particularly carbon dioxide emissions from fossil fuel use (IPCC 2007a, pp. 5-6 and figures SPM.3 and SPM.4; Solomon et al. 2007, pp. 21-35). Further confirmation of the role of GHGs comes from analyses by Huber and Knutti (2011, p. 4), who concluded it is extremely likely that approximately 75 percent of global warming since 1950 has been caused by human activities.

Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of GHG emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions (e.g., Meehl et al. 2007, entire; Ganguly et al. 2009, pp. 11555, 15558; Prinn et al. 2011, pp. 527, 529). All combinations of models and emissions scenarios yield very similar projections of average global warming until about 2030. Although projections of the magnitude and rate of warming differ after about 2030, the overall trajectory of all the projections is one of increased global warming through the end of this century, even for projections based on scenarios that assume that GHG emissions will stabilize or decline. Thus, there is strong scientific support for projections that warming will continue through the 21st century, and that the magnitude and rate of change will be influenced substantially by the extent of GHG emissions (IPCC 2007a, pp. 44-45; Meehl et al. 2007, pp. 760-764; Ganguly et al. 2009, pp. 15555-15558; Prinn et al. 2011, pp. 527, 529).

In addition to basing their projections on scientific analyses, the IPCC reports projections using a framework for treatment of uncertainties (e.g., they define “very likely” to mean greater than 90 percent probability, and “likely” to mean greater than 66 percent probability; see Solomon et al. 2007, pp. 22-23). Some of the IPCC's key projections of global climate and its related effects include: (1) It is virtually certain there will be warmer and more frequent hot days and nights over most of the earth's land areas; (2) it is very likely there will be increased frequency of warm spells and heat waves over most land areas; (3) it is very likely that the frequency of heavy precipitation events, or the proportion of total rainfall from heavy falls, will increase over most areas; and (4) it is likely the area affected by droughts will increase, that intense tropical cyclone activity will increase, and that there will be increased incidence of extreme high sea level (IPCC 2007b, p. 8, table SPM.2). More recently, the IPCC published additional information that provides further insight into observed changes since 1950, as well as projections of extreme climate events at global and broad regional scales for the middle and end of this century (IPCC 2011, entire).

Various changes in climate may have direct or indirect effects on species. These may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as interactions of climate with other variables such as habitat fragmentation (for examples, see Franco et al. 2006; IPCC 2007a, pp. 8-14, 18-19; Forister et al. 2010; Galbraith et al. 2010; Chen et al. 2011). In addition to considering individual species, scientists are evaluating possible climate change-related impacts to, and responses of, ecological systems, habitat conditions, and groups of species; these studies include acknowledgement of uncertainty (e.g., Deutsch et al. 2008; Berg et al. 2009; Euskirchen et al. 2009; McKechnie and Wolf 2009; Sinervo et al. 2010; Beaumont et al. 2011; McKelvey et al. 2011; Rogers and Schindler 2011).

Many analyses involve elements that are common to climate change vulnerability assessments. In relation to climate change, vulnerability refers to the degree to which a species (or system) is susceptible to, and unable to cope with, adverse effects of climate change, including climate variability and extremes. Vulnerability is a function of the type, magnitude, and rate of climate change and variation to which a species is exposed, its sensitivity, and its adaptive capacity (IPCC 2007a, p. 89; see also Glick et al. 2011, pp. 19-22). There is no single method for conducting such analyses that applies to all situations (Glick et al. 2011, p. 3). We use our expert judgment and appropriate analytical approaches to weigh relevant information, including uncertainty, in our consideration of various aspects of climate change.

As is the case with all stressors that we assess, even if we conclude that a species is currently affected or is likely to be affected in a negative way by one or more climate-related impacts, it does not necessarily follow that the species meets the definition of an “endangered species” or a “threatened species” under the Act. If a species is listed as endangered or threatened, knowledge regarding its vulnerability to, and known or anticipated impacts from, climate-associated changes in environmental conditions can be used to help devise appropriate strategies for its recovery.

Global climate projections are informative, and, in some cases, the only or the best scientific information available for us to use. However, projected changes in climate and related impacts can vary substantially across and within different regions of the world (e.g., IPCC 2007a, pp. 8-12). Therefore, we use “downscaled” projections when they are available and have been developed through appropriate scientific procedures, because such projections provide higher resolution information that is more relevant to spatial scales used for analyses of a given species (see Glick et al. 2011, pp. 58-61, for a discussion of downscaling). For our analysis for the Miami tiger beetle, downscaled projections are available.

According to the Florida Climate Center, Florida is by far the most vulnerable State in the United States to hurricanes and tropical storms (http://climatecenter.fsu.edu/topics/tropical-weather). Based on data gathered from 1856 to 2008, Klotzbach and Gray (2009, p. 28) calculated the climatological probabilities for each State being impacted by a hurricane or major hurricane in all years over the 152-year timespan. Of the coastal States analyzed, Florida had the highest climatological probabilities, with a 51 percent probability of a hurricane (Category 1 or 2) and a 21 percent probability of a major hurricane (Category 3 or higher). From 1856 to 2008, Florida actually experienced more major hurricanes than predicted; out of the 109 hurricanes, 36 were major hurricanes. The most recent hurricane to have major impacts to Miami-Dade County was Hurricane Andrew in 1992. While the species persisted after this hurricane, impacts to the population size and distribution from the storm are unknown, because no surveys were conducted until its rediscovery in 2007. Given the few, isolated populations of the Miami tiger beetle within a location prone to storm influences (located approximately 8 km (5 mi) from the coast), the species is at substantial risk from stochastic environmental events such as hurricanes, storm surges, and other extreme weather that can affect recruitment, population growth, and other population parameters.

Other processes to be affected by climate change, related to environmental stochasticity, include temperatures, rainfall (amount, seasonal timing, and distribution), and storms (frequency and intensity). Temperatures are projected to rise from 2-5 degrees Celsius (°C) (3.6-9 degrees Fahrenheit (°F)) for North America by the end of this century (IPCC 2007a, pp. 7-9, 13). Based upon predictive modeling, Atlantic hurricane and tropical storm frequencies are expected to decrease (Knutson et al. 2008, pp. 1-21). By 2100, there should be a 10-30 percent decrease in hurricane frequency. Hurricane frequency is expected to drop, due to more wind shear impeding initial hurricane development. However, hurricane winds are expected to increase by 5-10 percent. This is due to more hurricane energy available for intense hurricanes. These stronger winds will result in damage to the pine rockland vegetation and an increased storm surge (discussed below). In addition to climate change, weather variables are extremely influenced by other natural cycles, such as El Niño Southern Oscillation, with a frequency of every 4-7 years; solar cycle (every 11 years); and the Atlantic Multi-decadal Oscillation. All of these cycles influence changes in Floridian weather. The exact magnitude, direction, and distribution of all of these changes at the regional level are difficult to project.

The long-term record at Key West shows that sea level rose on average 0.229 cm (0.090 in) annually between 1913 and 2013 (National Oceanographic and Atmospheric Administration (NOAA) 2013, p. 1). This equates to approximately 22.9 cm (9.02 in) over the last 100 years. IPCC (2008, p. 28) emphasized it is very likely that the average rate of SLR during the 21st century will exceed the historical rate. The IPCC Special Report on Emission Scenarios (2000, entire) presented a range of scenarios based on the computed amount of change in the climate system due to various potential amounts of anthropogenic greenhouse gases and aerosols in 2100. Each scenario describes a future world with varying levels of atmospheric pollution, leading to corresponding levels of global warming and corresponding levels of SLR. The IPCC Synthesis Report (2007a, entire) provided an integrated view of climate change and presented updated projections of future climate change and related impacts under different scenarios.

Subsequent to the 2007 IPCC Report, the scientific community has continued to model SLR. Recent peer-reviewed publications indicate a movement toward increased acceleration of SLR. Observed SLR rates are already trending along the higher end of the 2007 IPCC estimates, and it is now widely held that SLR will exceed the levels projected by the IPCC (Rahmstorf et al. 2012, p. 1; Grinsted et al. 2010, p. 470). Taken together, these studies support the use of higher end estimates now prevalent in the scientific literature. Recent studies have estimated global mean SLR of 1.0-2.0 m (3.3-6.6 ft) by 2100 as follows: 0.75-1.90 m (2.5-6.2 ft; Vermeer and Rahmstorf 2009, p. 21530), 0.8-2.0 m (2.6-6.6 ft; Pfeffer et al. 2008, p. 1342), 0.9-1.3 m (3.0-4.3 ft; Grinsted et al. 2010, pp. 469-470), 0.6-1.6 m (2.0-5.2 ft; Jevrejeva et al. 2010, p. 4), and 0.5-1.40 m (1.6-4.6 ft; National Research Council 2012, p. 2).

All of the scenarios, from small climate change shifts to major changes, indicate negative effects on pine rockland habitat throughout Miami-Dade County. Prior to inundation, pine rocklands are likely to undergo habitat transitions related to climate change, including changes to hydrology and increasing vulnerability to storm surge. Hydrology has a strong influence on plant distribution in these and other coastal areas (IPCC 2008, p. 57). Such communities typically grade from salt to brackish to freshwater species. From the 1930s to 1950s, increased salinity of coastal waters contributed to the decline of cabbage palm forests in southwest Florida (Williams et al. 1999, pp. 2056-2059), expansion of mangroves into adjacent marshes in the Everglades (Ross et al. 2000, pp. 101, 111), and loss of pine rockland in the Keys (Ross et al. 1994, pp. 144, 151-155). In one Florida Keys pine rockland with an average elevation of 0.89 m (2.9 ft), Ross et al. (1994, pp. 149-152) observed an approximately 65 percent reduction in an area occupied by South Florida slash pine over a 70-year period, with pine mortality and subsequent increased proportions of halophytic (salt-loving) plants occurring earlier at the lower elevations. During this same time span, local sea level had risen by 15.0 cm (6.0 in), and Ross et al. (1994, p. 152) found evidence of groundwater and soil water salinization. Extrapolating this situation to pine rocklands on the mainland is not straightforward, but suggests that similar changes to species composition could arise if current projections of SLR occur and freshwater inputs are not sufficient to prevent salinization. Furthermore, Ross et al. (2009, pp. 471-478) suggested that interactions between SLR and pulse disturbances (e.g., storm surges) can cause vegetation to change sooner than projected based on sea level alone. Effects from vegetation shifts in the pine rockland habitat on the Miami tiger beetle are unknown, but because the beetle occurs in a narrow range and microhabitat parameters are still being studied, vegetation shifts could cause habitat changes or disturbance that would have a negative impact on beetle recruitment and survival. Alexander (1953, pp. 133-138) attributed the demise of pinelands on northern Key Largo to salinization of the groundwater in response to SLR. Patterns of human development will also likely be significant factors influencing whether natural communities can move and persist (IPCC 2008, p. 57; USCCSP 2008, pp. 7-6).

The Science and Technology Committee of the Miami-Dade County Climate Change Task Force (Wanless et al. 2008, p. 1) recognized that significant SLR is a very real threat to the near future for Miami-Dade County. In a January 2008 statement, the committee warned that sea level is expected to rise at least 0.9-1.5 m (3-5 ft) within this century (Wanless et al. 2008, p. 3). With a 0.9-1.2 m (3-4 ft) rise in sea level (above baseline) in Miami-Dade County: “Spring high tides would be at about 6 to 7 ft; freshwater resources would be gone; the Everglades would be inundated on the west side of Miami-Dade County; the barrier islands would be largely inundated; storm surges would be devastating; landfill sites would be exposed to erosion contaminating marine and coastal environments. Freshwater and coastal mangrove wetlands will not keep up with or offset SLR of 2 ft per century or greater. With a 5-ft rise (spring tides at nearly +8 ft), Miami-Dade County will be extremely diminished” (Wanless et al. 2008, pp. 3-4).

Drier conditions and increased variability in precipitation associated with climate change are expected to hamper successful regeneration of forests and cause shifts in vegetation types through time (Wear and Greis 2012, p. 39). Although it has not been well studied, existing pine rocklands have probably been affected by reductions in the mean water table. Climate changes are also forecasted to extend fire seasons and the frequency of large fire events throughout the Coastal Plain (Wear and Greis 2012, p. 43). While restoring fire to pine rocklands is essential to the long-term viability of the Miami tiger beetle (see Factor A discussion, above), increases in the scale, frequency, or severity of wildfires could have negative effects on the species (e.g., if wildfire occurs over the entire area occupied by the two known populations during the adult flight season when adults are present).

To accommodate the large uncertainty in SLR projections, researchers must estimate effects from a range of scenarios. Various model scenarios developed at Massachusetts Institute of Technology (MIT) and GeoAdaptive Inc. have projected possible trajectories of future transformation of the south Florida landscape by 2060, based upon four main drivers: climate change, shifts in planning approaches and regulations, human population change, and variations in financial resources for conservation (Vargas-Moreno and Flaxman 2010, pp. 1-6). The scenarios do not account for temperature, precipitation, or species habitat shifts due to climate change, and no storm surge effects are considered. The current MIT scenarios range from an increase of 0.09-1.00 m (0.3-3.3 ft) by 2060.

Based on the most recent estimates of SLR and the data available to us at this time, we evaluated potential effects of SLR using the current “high” range MIT scenario, as well as comparing elevations of remaining pine rockland fragments and extant occurrences of the Miami tiger beetle. The “high” range (or “worst case”) MIT scenario assumes high SLR (1.0 m (3.3 ft) by 2060), low financial resources, a `business as usual' approach to planning, and a doubling of human population. Based on this scenario, pine rocklands along the coast in central Miami-Dade County would become inundated. The “new” sea level (1.0 m (3.3 ft) higher) would come up to the edge of pine rockland fragments at the southern end of Miami-Dade County, translating to partial inundation or, at a minimum, vegetation shifts for these pine rocklands. While sea level under this scenario would not overtake other pine rocklands in urban Miami-Dade County, including the known locations for the Miami tiger beetle, changes in the salinity of the water table and soils would surely cause vegetation shifts that may negatively impact the viability of the beetle. In addition, many existing pine rockland fragments are projected to be developed for housing as the human population grows and adjusts to changing sea levels under this “high” range (or “worst case”) MIT scenario. Actual impacts may be greater or less than anticipated based upon high variability of factors involved (e.g., SLR, human population growth) and assumptions made in the model.

When simply looking at current elevations of pine rockland fragments and occurrences of the Miami tiger beetle, it appears that an SLR of 1 m (3.3 ft) will inundate the coastal and southern pine rocklands and cause vegetation shifts largely as described above. SLR of 2 m (6.6 ft) appears to inundate much larger portions of urban Miami-Dade County. The western part of urban Miami-Dade County would also be inundated (barring creation of sea walls or other barriers), creating a virtual island of the Miami Rock Ridge. After a 2-m rise in sea level, approximately 75 percent of the remaining pine rockland would still be above sea level but an unknown percentage of these fragments would be negatively impacted by salinization of the water table and soils, which would be exacerbated due to isolation from mainland fresh water flows. Above 2 m (6.6 ft) of SLR, very little pine rockland would remain, with the vast majority either being inundated or experiencing vegetation shifts.

The climate of southern Florida is driven by a combination of local, regional, and global events, regimes, and oscillations. There are three main “seasons”: (1) The wet season, which is hot, rainy, and humid from June through October; (2) the official hurricane season that extends 1 month beyond the wet season (June 1 through November 30), with peak season being August and September; and (3) the dry season, which is drier and cooler, from November through May. In the dry season, periodic surges of cool and dry continental air masses influence the weather with short-duration rain events followed by long periods of dry weather.

Climate change may lead to increased frequency and duration of severe storms (Golladay et al. 2004, p. 504; McLaughlin et al. 2002, p. 6074; Cook et al. 2004, p. 1015). Hurricanes and tropical storms can modify habitat (e.g., through storm surge) and have the potential to destroy the only known population of the Miami tiger beetle and its suitable habitat. With most of the historical habitat having been destroyed or modified, the two known remaining populations of the beetle are at high risk of extirpation due to stochastic events.

The Miami tiger beetle is anticipated to face major risks from coastal squeeze, which occurs when habitat is pressed between rising sea levels and coastal development that prevents landward movement (Scavia et al. 2002, entire; FitzGerald et al. 2008, entire; Defeo et al. 2009, p. 8; LeDee et al. 2010, entire; Menon et al. 2010, entire; Noss 2011, entire). Habitats in coastal areas (i.e., Charlotte, Lee, Collier, Monroe, Miami-Dade Counties) are likely the most vulnerable. Although it is difficult to quantify impacts due to the uncertainties involved, coastal squeeze will likely result in losses in habitat for the beetles as people and development are displaced further inland.

Based on our analysis of the best available information, we have identified a wide array of natural and manmade factors affecting the continued existence of the Miami tiger beetle. The beetle is immediately vulnerable to extinction, due to the effects of few remaining small populations, restricted range, and isolation. Aspects of the Miami tiger beetle's natural history (e.g., limited dispersal) and environmental stochasticity (including hurricanes and storm surge) may also contribute to imperilment. Other natural (e.g., changes to habitat, invasive and exotic vegetation) and anthropogenic (e.g., habitat alteration, impacts from humans) factors are also identifiable threats. Climate change, sea-level rise, and coastal squeeze are major concerns. Collectively, these threats have occurred in the past, are impacting the species now, and will continue to impact the species in the future.

The limited distribution, small population size, few populations, and relative isolation of the Miami tiger beetle makes it extremely susceptible to further habitat loss, modification, degradation, and other anthropogenic threats. The Miami tiger beetle's viability at present is uncertain, and its continued persistence is in danger, unless protective actions are taken. Mechanisms causing the decline of this beetle, as discussed above, range from local (e.g., lack of adequate fire management, vegetation encroachment), to regional (e.g., development, fragmentation, nonnative species), to global influences (e.g., climate change, SLR). The synergistic effects of threats (such as hurricane effects on a species with a limited distribution consisting of just two known populations) make it difficult to predict population viability now and in the future. While these stressors may act in isolation, it is more probable that many stressors are acting simultaneously (or in combination) on the Miami tiger beetle.

We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the Miami tiger beetle. Habitat loss, degradation, and fragmentation have destroyed an estimated 98 percent of the historical pine rockland habitat in Miami-Dade County, with only two known populations remaining. The threat of habitat loss is continuing from development, inadequate habitat management resulting in vegetation encroachment, and environmental effects resulting from climatic change (see discussions under Factors A and E). Due to the restricted range, small population size, few populations, and relative isolation (see Factor E), collection is a significant threat to the species and could potentially occur at any time (see discussions under Factor B). Additionally, the species is currently threatened by a wide array of natural and manmade factors (see Factor E). Existing regulatory mechanisms do not provide adequate protection for the species (see Factor D). As a result, impacts from increasing threats, singly or in combination, are likely to result in the extinction of the species because the magnitude of threats is high.

The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that the Miami tiger beetle is presently in danger of extinction throughout its entire range based on the severity and immediacy of threats currently affecting the species. The overall range has been significantly impacted because of significant habitat loss, degradation, and fragmentation of pine rockland habitat. Newly proposed development is currently threating the only known population of this species. The fragmented nature of Miami-Dade County's remaining pine rockland habitat and the influx of development around them may preclude the ability to conduct prescribed burns or other beneficial management actions that are needed to prevent vegetation encroachment. The remaining two known, small populations of the Miami tiger beetle appears to occupy relatively small habitat patches, which make the population vulnerable to local extinction from normal fluctuations in population size, genetic problems from small population size, or environmental catastrophes. Limited dispersal abilities in combination with limited habitat may result in local extirpations.

Therefore, on the basis of the best available scientific and commercial information, we propose to list the Miami tiger beetle as an endangered species in accordance with sections 3(6) and 4(a)(1) of the Act. We find that a threatened species status is not appropriate for the Miami tiger beetle because of significant habitat loss (i.e., 98 percent of pine rockland habitat in Miami-Dade County) and degradation; the fact that only two known small populations of the species remain; and the imminent threat of large development projects in the Richmond pine rocklands.

Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. The threats to the survival of the species occur throughout the species' range and are not restricted to any particular significant portion of that range. Accordingly, our assessment and proposed determination apply to the species throughout its entire range.

Conservation measures provided to species listed as endangered or threatened under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies; private organizations; and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan also identifies recovery criteria for review of when a species may be ready for downlisting or delisting, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our Web site (http://www.fws.gov/endangered), or from the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of this species requires cooperative conservation efforts on private, State, and Tribal lands. If the Miami tiger beetle is listed, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Florida would be eligible for Federal funds to implement management actions that promote the protection or recovery of the Miami tiger beetle. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

Although the Miami tiger beetle is only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for this species. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action that is likely to jeopardize the continued existence of a species proposed for listing or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

Federal agency actions within the species' habitat that may require conference or consultation or both, as described in the preceding paragraph, include management and any other landscape-altering activities on Federal lands administered by the U.S. Coast Guard, U.S. Army Corps of Engineers, and other Federal agencies; issuance of section 404 Clean Water Act (33 U.S.C. 1251 et seq.) permits by the U.S. Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration.

The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to all endangered and threatened wildlife. The prohibitions of section 9(a)(2) of the Act, codified at 50 CFR 17.21 for endangered wildlife, in part, make it illegal for any person subject to the jurisdiction of the United States to take (includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these), import, export, ship in interstate commerce in the course of commercial activity, or sell or offer for sale in interstate or foreign commerce any listed species. Under the Lacey Act (18 U.S.C. 42-43; 16 U.S.C. 3371-3378), it is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to agents of the Service and State conservation agencies. 50 CFR 17.31 generally applies the prohibitions for endangered wildlife to threatened wildlife, unless a rule issued under section 4(d) of the Act is adopted by the Service.

We may issue permits to carry out otherwise prohibited activities involving endangered and threatened wildlife species under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22 for endangered species, and at 17.32 for threatened species. With regard to endangered wildlife, a permit must be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify, to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a proposed listing on proposed and ongoing activities within the range of species proposed for listing. Based on the best available information, the following activities involving the Miami tiger beetle (including all of its metamorphic life stages) may potentially result in a violation of section 9 of the Act; this list is not comprehensive:

(1) Unauthorized possession, collecting, trapping, capturing, killing, harassing, sale, delivery, or movement, including interstate and foreign commerce, or harming or attempting any of these actions, at any life stage without a permit (research activities where Miami tiger beetles are surveyed, captured (netted), or collected will require a permit under section 10(a)(1)(A) of the Act).

(2) Incidental take without a permit pursuant to section 10(a)(1)(B) of the Act.

(3) Sale or purchase of specimens, except for properly documented antique specimens of this taxon at least 100 years old, as defined by section 10(h)(1) of the Act.

(4) Unauthorized use of pesticides/herbicides that results in take.

(5) Release of biological control agents that attack any life stage.

(6) Discharge or dumping of toxic chemicals, silts, or other pollutants into, or other alteration of the quality of, habitat supporting the Miami tiger beetles that result in take.

(7) Unauthorized activities (e.g., plowing; mowing; burning; herbicide or pesticide application; land leveling/clearing; grading; disking; soil compaction; soil removal; dredging; excavation; deposition of dredged or fill material; erosion and deposition of sediment/soil; grazing or trampling by livestock; minerals extraction or processing; residential, commercial, or industrial developments; utilities development; road construction; or water development and impoundment) that take eggs, larvae, or adult Miami tiger beetles or that modify Miami tiger beetle habitat in such a way that take Miami tiger beetles by adversely affecting their essential behavioral patterns, including breeding, foraging, sheltering, or other life functions. Otherwise lawful activities that incidentally take Miami tiger beetles, but have no Federal nexus, will require a permit under section 10(a)(1)(B) of the Act.

Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

Section 3(5)(A) of the Act defines critical habitat as “(i) the specific areas within the geographical area occupied by the species, at the time it is listed . . . on which are found those physical or biological features (I) Essential to the conservation of the species and (II) which may require special management considerations or protection; and (ii) specific areas outside the geographical area occupied by the species at the time it is listed . . . upon a determination by the Secretary that such areas are essential for the conservation of the species.” Section 3(3) of the Act (16 U.S.C. 1532(3)) defines the terms “conserve,” “conserving,” and “conservation” to mean “to use and the use of all methods and procedures which are necessary to bring any endangered species or threatened species to the point at which the measures provided pursuant to this Act are no longer necessary.”

Section 4(a)(3) of the Act, as amended, and implementing regulations (50 CFR 424.12), require that, to the maximum extent prudent and determinable, the Secretary shall designate critical habitat at the time the species is determined to be an endangered or threatened species. Our regulations (50 CFR 424.12(a)(1)) state that the designation of critical habitat is not prudent when one or both of the following situations exist:

(1) The species is threatened by taking or other human activity, and identification of critical habitat can be expected to increase the degree of threat to the species, or

(2) Such designation of critical habitat would not be beneficial to the species.

There is currently an imminent threat of take attributed to collection or vandalism described under Factor B, above, for the species. However, it is believed that the majority of occurrences of Miami tiger beetles are well known. Although the location of the new population is less well known, awareness of this population is increasing in the natural resource community. We believe that the benefits of designating critical habitat will outweigh the risks associated with increased collection from mapping and identifying critical habitat.

Therefore, in the absence of finding that the designation of critical habitat would increase threats to a species, if there are any benefits to a critical habitat designation, a finding that designation is prudent is warranted. Here, the potential benefits of designation include: (1) Triggering consultation under section 7 of the Act, in new areas for actions in which there may be a Federal nexus where it would not otherwise occur because, for example, it is unoccupied; (2) focusing conservation activities on the most essential features and areas; (3) providing educational benefits to State or county governments or private entities; and (4) preventing people from causing inadvertent harm to these species.

Because we have determined that the designation of critical habitat will not likely increase the degree of threat to the species and may provide some measure of benefit, we determine that designation of critical habitat may be prudent for the Miami tiger beetle.

Our regulations (50 CFR 424.12(a)(2)) further state that critical habitat is not determinable when one or both of the following situations exists: (1) Information sufficient to perform required analysis of the impacts of the designation is lacking; or (2) the biological needs of the species are not sufficiently well known to permit identification of an area as critical habitat. On the basis of a review of available information, we find that critical habitat for the Miami tiger beetle is not determinable because the specific information sufficient to perform the required analysis of the impacts of the designation is currently lacking. Specifically, we are still in the process of obtaining all the information needed to properly evaluate the economic impacts of designation.

We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(1) Be logically organized;

(2) Use the active voice to address readers directly;

(3) Use clear language rather than jargon;

(4) Be divided into short sections and sentences; and

(5) Use lists and tables wherever possible.

If you feel that we have not met these requirements, send us comments by one of the methods listed in the ADDRESSES section. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act, need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

A complete list of references cited in this rulemaking is available on the Internet at http://www.regulations.gov and upon request from the South Florida Ecological Services Office (see FOR FURTHER INFORMATION CONTACT).

The primary authors of this proposed rule are the staff members of the South Florida Ecological Services Office.

Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the CFR, as set forth below: