Federal Register Vol. 83, No.20,

Background

The regulations in 7 CFR part 319 prohibit or restrict the importation into the United States of certain plants and plant products to prevent the introduction of plant pests and noxious weeds. The regulations in “Subpart—Plants for Planting,” §§ 319.37 through 319.37-14 (referred to below as the regulations) contain, among other things, prohibitions and restrictions on the importation of plants, plant parts, and seeds for propagation.

Paragraph (a) of § 319.37-8 of the regulations requires, with certain exceptions, that plants offered for importation into the United States be free of sand, soil, earth, and other growing media. This requirement is intended to help prevent the introduction of plant pests that might be present in the growing media; the exceptions to the requirement take into account factors that mitigate plant pest risks. Those exceptions, which are found in paragraphs (b) through (e) of § 319.37-8, consider either the origin of the plants and growing media (paragraph (b)), the nature of the growing media (paragraphs (c) and (d)), or the use of a combination of growing conditions, approved media, inspections, and other requirements (paragraph (e)).

Paragraph (e) of § 319.37-8 provides conditions under which certain plants established in growing media may be imported into the United States. In addition to specifying the types of plants that may be imported, § 319.37-8(e) also:

• Specifies the types of growing media that may be used;

• Requires plants to be grown in accordance with written agreements between the Animal and Plant Health Inspection Service (APHIS) and the national plant protection organization (NPPO) of the country where the plants are grown and between the foreign NPPO and the grower;

• Requires the plants to be rooted and grown for a specified period in a greenhouse that meets certain requirements for pest exclusion and that is used only for plants being grown in compliance with § 319.37-8(e);

• Requires that the parent plants of the exported plants in growing media are produced from seed germinated in the production greenhouse or from mother plants that are grown and monitored for a specified period prior to export of the descendant plants;

• Specifies the sources of water that may be used on the plants, the height of the benches on which the plants must be grown, and the conditions under which the plants must be stored and packaged; and

• Requires that the plants be inspected in the greenhouse and found free of evidence of plant pests no more than 30 days prior to the exportation of the plants.

A phytosanitary certificate issued by the NPPO of the country in which the plants were grown that declares that the above conditions have been met must accompany the plants at the time of importation. These conditions have been used to successfully mitigate the risk of pest introduction associated with the importation into the United States of approved plants established in growing media.

In response to a request from the NPPO of Taiwan, we prepared a pest risk assessment (PRA) in order to identify the quarantine plant pests that could follow the importation of orchid plants of the genus Dendrobium in approved growing media from Taiwan into the United States. (Under § 319.37-1 of the regulations, a quarantine plant pest is a plant pest that is of potential economic importance to the United States and not yet present in the United States, or present but not widely distributed and being officially controlled.)

Based on the findings of the PRA, we prepared a risk management document (RMD) to determine whether phytosanitary measures exist that would address this quarantine plant pest risk. The RMD suggested that the risk would be addressed if the plants met the general conditions of § 319.37-8(e).

As a result, on October 27, 2016, we published in the Federal Register (81 FR 74720-74722, Docket No. APHIS-2016-0005) a proposal 1 to amend the regulations by adding Dendrobium spp. from Taiwan to the list of plants established in an approved growing medium that may be imported into the United States. The plants will have to be produced, handled, and imported in accordance with the requirements of § 319.37-8(e) and be accompanied at the time of importation by a phytosanitary certificate issued by the NPPO of Taiwan that declares that those requirements have been met.

We solicited comments concerning our proposal for 60 days ending December 27, 2016. We received 11 comments by that date. They were from a scientific group, industry organizations, a State department of agriculture, and private citizens. They are discussed below by topic.

One commenter was supportive of the proposed action but requested that we also allow for the importation of carnivorous plants from Taiwan as they are grown in the same medium.

The request submitted by the NPPO of Taiwan concerned the importation of Dendrobium spp. orchids only. Were Taiwan to submit a request to import carnivorous plants in approved growing media we would consider and analyze that request as we would any other.

Another commenter, from the Florida Department of Agriculture and Consumer Services, Division of Plant Industry (FDACS' DPI), stated that U.S. stakeholders from those areas potentially affected by any pest or disease outbreak from imported commodities should be invited to participate in site visits prior to the proposal of any rulemakings such as the one finalized by this document.

APHIS is committed to a transparent process and an inclusive role for stakeholders in our risk analysis process. To that end, we are currently considering ways to facilitate further stakeholder involvement, including site visits, during the initial stages of the development of PRAs. However, since this comment relates to the structure of APHIS' overall risk analysis process, and not to the importation of Dendrobium spp. orchids from Taiwan, it is outside the scope of the current rulemaking.

A commenter requested that we take into consideration the increased workload of border inspectors and the potential impact of additional imports on inspection times and treatment facilities.

APHIS has reviewed its resources and consulted with U.S. Customs and Border Protection and believes there is adequate coverage across the United States to ensure compliance with APHIS regulations, including the importation of Dendrobium spp. orchids in approved growing media, as established by this rule.

One commenter wanted to know how the importation of Dendrobium spp. orchids in approved growing media would benefit domestic orchid growers and consumers. The commenter speculated that the imported Dendrobium spp. orchids would be of lower quality compared to the domestic flowers. The commenter wanted to know whether APHIS was planning to implement any programs to assist domestic orchid growers in the face of foreign competition.

It is beyond APHIS' statutory authority to prohibit importation of a commodity for any reason other than to prevent the introduction or dissemination of a plant pest or noxious weed within the United States. Under the Plant Protection Act (PPA), APHIS may prohibit the importation of a fruit or vegetable into the United States only if we determine that the prohibition is necessary in order to prevent the introduction or dissemination of a plant pest or noxious weed within the United States.

A commenter said that APHIS should further study the potential phytosanitary impacts and set out additional requirements prior to allowing for the importation of Dendrobium spp. orchids from Taiwan.

The PRA and RMD that accompanied the proposed rule evaluated the quarantine plant pest risk associated with the importation of Dendrobium spp. orchids in approved growing media from Taiwan into the United States. These documents provided scientific evidence that a prohibition on the importation of Dendrobium spp. orchids in approved growing media is not necessary in order to protect plant health in the United States, and the risk associated with such importation could be addressed by requiring the orchids and growing media to be produced in accordance with §  319.37-8(e). We prepared the PRA and RMD in accordance with relevant International Plant Protection Convention (IPPC) standards (see International Standards for Phytosanitary Measures (ISPM) No. 11, found at http://www.acfs.go.th/sps/downloads/34163_ISPM_11_E.pdf) and our own guidelines, and we are confident that they adequately evaluated the plant pest risk associated with the importation of Dendrobium spp. orchids in approved growing media from Taiwan into the United States.

Another commenter expressed concern that the NPPO of Taiwan or its designated representatives would not perform required inspections to a sufficiently high standard and therefore allow pests of concern to enter the United States.

The United States is a member of the World Trade Organization (WTO), and a signatory to the WTO's Agreement on Sanitary and Phytosanitary Measures (SPS Agreement) and the IPPC. In these capacities, the United States has agreed that any prohibitions it places on the importation of plants for planting will be based on scientific evidence, and will not be maintained without sufficient scientific evidence indicating that the prohibitions are necessary to protect plants within the United States. Like the United States, Taiwan is a signatory to the SPS Agreement. As such, it has agreed to respect the phytosanitary measures the United States imposes on the importation of plants and plant products from Taiwan when the United States demonstrates the need to impose these measures in order to protect plant health within the United States. Were pests of concern to be discovered in shipments of Dendrobium spp. orchids in approved growing media from Taiwan, we reserve the right to halt importation and address the issue with the NPPO of Taiwan.

Two commenters cited reports of unknown pests discovered in connection with orchids from Taiwan: microscopic mites in the flower pollen and sphagnum moss-eating insects in the growing media. These reports suggested to the commenters that the PRA and RMD prepared by APHIS might not be reliable.

After careful review of our pest interception data, we found that only 48 actionable pests were intercepted in connection with all species of orchids imported from Taiwan over the last 5 years, which is less than 10 interceptions per year. The pests intercepted specifically in connection with shipments of Dendrobium spp. orchids in the past 5 years were: Snails (three interceptions), mealybugs (one interception), thrips (two interceptions), and fungal plant pathogens (five interceptions). All orchid shipments containing actionable pests were fumigated, destroyed, or returned to Taiwan to ensure that no pests were able to enter the United States.

There have been no interceptions of mites on Dendrobium spp. orchids from Taiwan, nor have there been any interceptions of organisms in sphagnum moss. The approved growing media, including sphagnum moss, listed in paragraph (e)(1) of § 319.37-8 must be new and not have been previously used. Prior evaluation by APHIS has revealed that approved growing media not previously used for planting is unlikely to be colonized by quarantine pests. All growing media must be sourced, processed, packaged, handled and stored in a manner to ensure freedom from pests.

Another commenter argued that the potential for the presence of quarantine pests associated with approved growing media or plants is always present. The commenter said that these pests or evidence of their presence may not be visible upon inspection or may be missed during the inspection process.

If the provisions of the proposed rule are adhered to, there will be a negligible risk that Dendrobium spp. orchids in approved growing media from Taiwan that are imported into the United States will harbor quarantine plant pests.

That being said, pursuant to §§  319.37-3 and 319.37-11 of the regulations, lots of Dendrobium spp. orchids in approved growing media from Taiwan that consist of 13 or more plants must be imported to a United States Department of Agriculture plant inspection station for entry into the United States—we anticipate that almost all lots of Dendrobium spp. orchids in approved growing media from Taiwan that are exported to the United States will consist of more than 13 plants. Personnel at plant inspection stations are trained to detect plant pests and signs and symptoms of plant pests, including those that are difficult to detect, and have access to personnel with scientific expertise in identifying plant pests.

One commenter cited a previous rule (81 FR 5881-5888, Docket No. APHIS-2014-0041) that authorized the importation of Oncidium spp. orchids from Taiwan in approved growing media where we provided interception data related to the importation of Phalaenopsis spp. orchids in approved growing media from Taiwan. The commenter disagreed with our assertion that the average interception rate for pests of concern in connection with shipments of Phalaenopsis spp. orchids in approved growing media from Taiwan (23 consignments determined infested per year) is statistically insignificant.

We disagree and reiterate that an average of 23 infested shipments out of the approximately 20 million Phalaenopsis spp. orchids in approved growing media exported from Taiwan to the United States each year is a vanishingly small number that serves as proof of the efficacy of the systems approach. There is no evidence that any plant pests have been introduced into the United States through the importation of Phalaenopsis spp. orchids in growing media from Taiwan. The commenter provided no evidence to support the claim of statistical significance.

Another commenter referenced a 2012 study released by the European and Mediterranean Plant Protection Organization (EPPO) titled “EPPO Study on the Risk of Imports of Plants for Planting.” 2 The commenter highlighted several findings of that study which were determined by EPPO to represent high risk of plant pest introduction:

• Presence of growing medium, which could lead to the transport of many types of pests, including nematodes, fungi, insects, and invasive plants. The commenter cited the orchid snail (Zonitoides arboreus) in the State of Hawaii as an example, where the growth of the commercial potted orchid industry and that industry's use of moist bark and coconut fiber media were connected to a dramatic increase in snail damage and prevalence in the 1990s;

• Size of the plants. The commenter's assumption was that plants in growing medium would be larger than the bare root plants previously allowed importation. Larger plants are older and allow more time for pest infestation to occur and more places on the plant to infest;

• Production mode. Wild-collected plants are highest risk and easily disguised among cultivated plants when potted in identical containers and media;

• Unidentified risk. Those quarantine pests considered by the study were not known to represent a phytosanitary risk prior to their introduction, and their features would not have suggested a risk if assessed individually. The commenter cited the fungus Ceratocystis fimbriata, the causal agent of rapid Ohi'a death, which was previously unknown to science and was not on any list of quarantine pests, but is most similar to a disease shipped in potted plants.

The PRA contained an evaluation of the likelihood that quarantine snails, slugs, and nematodes that occur in Taiwan and are associated with Dendrobium spp. orchids will follow the pathway on Dendrobium spp. orchids in approved growing media to the United States. If the snails, slugs, or nematodes were considered to potentially follow the pathway, the PRA evaluated the likelihood of their introduction into the United States through this pathway, and the consequences of this introduction. Bark is not listed in § 319.37-8 as an approved growing medium and, while coconut fiber is among the approved growing media, as stated previously, all growing media must be new and not have been previously used, thus decreasing the risk that it will be infested.

Contrary to the commenter's assumption that plants imported in growing media would be older and therefore larger than the bare root plants already allowed importation, plants in growing media are subject to the same size and age restrictions as bare root plants. In addition, as mentioned earlier in this document, lots of 13 or more Dendrobium spp. orchids in approved growing media from Taiwan would have to be imported to a plant inspection station for entry into the United States where they will be carefully examined by trained inspectors.

Plants in growing media pose no greater risk of commingling with wild-collected plants than other types of plant material; indeed the more numerous inspections required of plants in growing media during the production process likely makes such commingling more difficult. However, if we determine that the standard of production agreed upon by APHIS and the NPPO of Taiwan is not being met (e.g., commingling wild-collected plants with greenhouse grown plants), we reserve the right to halt importations of Dendrobium spp. orchids in approved growing media from Taiwan until such time that we are confident that the required systems approach will be followed.

C. fimbriata was originally described in connection with sweet potato in 1890. It has since been found on a wide variety of annual and perennial plants. It is not yet known whether the C. fimbriata causing rapid Ohi'a death in Hawaii represents a new strain imported on an as-yet unknown commodity or an existing strain that mutated in Hawaii. The PRA that accompanied the proposed rule provided a list of all pests of Dendrobium spp. orchids in approved growing media from Taiwan. This list was prepared using multiple data sources to ensure its completeness. For this same reason, we are confident it is accurate. If, however, a new pest is detected in connection with Dendrobium spp. orchids in approved growing media from Taiwan (e.g., the causal agent for rapid Ohi'a death is conclusively linked to that commodity), APHIS will conduct further risk analysis in order to evaluate that pest to determine whether it is a quarantine pest, and whether it is likely to follow the importation pathway. If we determine that the pest is a quarantine pest and is likely to follow the pathway, we will work with the NPPO of Taiwan to adjust the pest list and related phytosanitary measures to prevent its introduction into the United States.

Another commenter expressed concern that APHIS would not have sufficient inspectors at the ports of entry into the United States, allowing for pest entry.

APHIS has reviewed its resources and believes it has adequate resources available to ensure compliance with the conditions of the final rule.

One commenter stated that there is no virus testing at U.S. ports of entry and wanted to know if such testing occurs prior to export.

We do not consider virus testing necessary given that the PRA did not identify any quarantine viruses that occur in Taiwan and are associated with Dendrobium spp. orchids. If that situation were to change we would work with the NPPO of Taiwan to develop requirements relating to viral testing for any quarantine viruses.

As part of the PRA, we prepared a list of plant pests that are associated with Dendrobium spp. orchids and that we determined to occur in Taiwan. We determined that three quarantine pests present in Taiwan could potentially follow the import pathway:

• Helionothrips errans (Williams), a thrips;

• Scirtothrips dorsalis Hood, the chili thrips; and

• Spodoptera litura (Fabricius), the Oriental leafworm moth.

FDACS' DPI stated that an accidental introduction of the Oriental leafworm moth would be particularly damaging to the State of Florida because it is a known pest of some of that State's most significant crops. The commenter said that Oriental leafworm moth is intercepted in connection with orchids at ports of entry on a regular basis and has been discovered at least five times in Florida nurseries since 2002; some of these finds were associated with Dendrobium spp.

The required systems approach will remove pests from pathway of importation of Dendrobium spp. orchids from Taiwan. Oriental leafworm moth eggs and larvae (the life stages of the pest associated with Dendrobium spp. orchids from Taiwan) are conspicuous pests that are relatively easy to detect upon visual inspection. Plants in growing media will be produced in pest exclusionary structures subject to required pest management programs. While it is true that Oriental leafworm moth has been intercepted at the ports, these interceptions have not been made in connection with orchids imported from China or Taiwan. Those Oriental leafworm moths associated with Dendrobium spp. orchids discovered in Florida greenhouses were likely associated with plants smuggled into the United States and not grown using the necessary containment methods to prevent infestation.

Another commenter said that because Helionothrips errans and the chili thrips are very small and insert their eggs into plant material, evidence of infestation may go undetected.

In addition to the pest exclusionary structures discussed previously, the post-harvest requirement that the plants be kept dry for 7-10 days prior to packing in approved growing media will allow for the emergence of any thrips previously undetected due to their location inside the plant.

One commenter pointed out that Fusarium (a genus of pathogenic fungi) exists in Taiwan and can be persistent in plant populations there since full control measures require the elimination of all contaminated plants and the implementation of strict disease control measures.

While we are aware that multiple species of Fusarium occur in Taiwan, none of these are known to be associated with Dendrobium spp. orchids. Further, when we have detected Fusarium spp. on susceptible commodities at ports of entry into the United States, the species detected have been ones that are already widely prevalent within the United States and therefore not considered to be quarantine pests.

Two commenters pointed out that APHIS data shows that the systems approach does miss quarantine pests and argued that this was proof that further study and implementation of additional phytosanitary measures are needed before additional importation is allowed.

We have stated in the past that if zero tolerance for pest risk were the standard applied to international trade in agricultural commodities, it is quite likely that no country would ever be able to export a fresh agricultural commodity to any other country and, thus, zero risk is not a realistic standard. We are confident, based on our knowledge and experience, that the required phytosanitary measures laid out in this rule and in the preceding proposed rule will be sufficient to reduce risk.

One commenter stated that because the required screens can be easily removed from greenhouse ventilators and reinstalled prior to the arrival of inspectors, we should implement a required monitoring system so that the screening cannot be removed between inspections.

We reserve the right to conduct monitoring of the development and implementation of the required pest management plans. However, we do not consider it necessary for us to require APHIS to monitor the development and implementation of each pest management plan within any specific place of production. For other export programs for plants and plant products from Taiwan to the United States, we have exercised joint monitoring responsibilities with the NPPO of Taiwan, and we have not encountered any issues that suggest we should modify this practice.

Another commenter said that a large percentage of plants imported into the State of Florida from China and Taiwan test positive for common orchid viruses. The commenter claimed that this is due to the use of large plant pieces for multiplication since, when this is done, any pathogens present on the original plant will also be present on those plants propagated from that plant's parts. The commenter argued that many pathogens, such as viruses, bacteria, and Liberibacters including zebra chip, citrus greening, and Xylella fastidiosa, may be present on plants but remain asymptomatic, thus escaping detection via visual inspection. As a result, the commenter recommended the following additional phytosanitary measures: The growing area should exclude all pests capable of vectoring pathogens and be inspected on a quarterly basis to ensure freedom from such pests; and a percentage of plants should be randomly indexed for pathogens at least biannually.

The PRA did not identify any viruses that can follow the pathway of importation of Dendrobium spp. orchids from Taiwan. In addition, the pathogens specifically referenced by the commenter are not orchid pests: Zebra chip is a pest of potatoes, citrus greening is a pest of citrus, and Xylella fastidiosa is the causal agent for diseases of olives, citrus, grapes, and landscape oleanders. Nonetheless, growers will be required to perform specific sanitary measures under the requirements of the rule and the operational workplan that APHIS enters into with the NPPO of Taiwan. The required greenhouse operating procedures will include measures designed to exclude pests from the greenhouse and implementation of a pest management plan to control disease vectors.

FDACS' DPI recommended that shipment of Dendrobium spp. orchids from Taiwan not be allowed into the State of Florida given that the climate in that State is particularly conducive to the establishment of the pests associated with Dendrobium spp. orchids.

We have determined, for the reasons described in the RMD that accompanied the proposed rule, that the measures specified in the RMD will effectively mitigate the risk associated with the importation of Dendrobium spp. orchids from Taiwan. The commenter did not provide any evidence suggesting that the mitigations are not effective. Therefore, we are not taking the action requested by the commenter.

One commenter stated that the increase of foreign-produced orchids in the domestic market will force most domestic orchid farmers out of business. A second commenter expressed the belief that this scenario would be driven by lower production costs, due mainly to lower labor rates in Taiwan and a climate more favorable to orchid production absent the need for artificial heating and cooling.

The importation Dendrobium spp. orchids into the United States from Taiwan is already allowed; it is only their importation in approved growing media that is not currently authorized. Taiwan may shift some exports from bare-rooted Dendrobium spp. orchids to rooted plants in approved growing media to meet U.S. consumer demand. We note that, by value, U.S. production of Dendrobium spp. orchids does not represent a large portion of U.S. orchid production (4 percent of production in 2014). While orchid producers in Taiwan may benefit from lower labor costs, the quantity of Dendrobium spp. plants in approved growing media exported to the United States will still depend on the ability of those producers and exporters to cover their production, transportation, and marketing costs in light of U.S. market prices. APHIS expects Taiwan orchid producers to incur higher production and shipping costs as compared to those for bare-rooted plants.

A commenter classified the proposed action as a lessening of regulatory requirements and predicted that it would prove detrimental to the domestic orchid industry by setting a precedent for less stringent regulations.

The Secretary considers many factors in making a determination to allow the import of a previously prohibited article, such as potential environmental effects and the economic effects associated with the introduction of a plant pest or noxious weed. The determination to allow an import under the PPA, however, is ultimately based on the Secretary's determination that the importation of a commodity will not result in the introduction into or dissemination within the United States of a plant pest or noxious weed. This approach is consistent with APHIS' obligations under the PPA and international trade agreements. Part of APHIS' mission is to facilitate exports, and we strive to do so. Success in this area is somewhat tied to factors out of our control, but we make every effort to assist domestic industry in securing access to export markets.

The same commenter expressed the belief that the Taiwanese orchid industry is given financial assistance by the government of that country that gives those growers an advantage over domestic producers who are not similarly assisted by the U.S. Government.

APHIS has no reason to believe that Dendrobium spp. producers or shippers are subsidized by Taiwan. However, even if they were, as stated elsewhere in this document, APHIS' determinations as to whether a new agricultural commodity can be safely imported are not affected by factors such as economic competitiveness.

Another commenter asked us to consider the future budgetary resources required for pest management programs and facilities given the likely increase the prevalence of quarantine pests overall.

APHIS allocates substantial resources for the identification of invasive pests, including pest identifiers and taxonomic specialists. We also allocate resources to States through the Cooperative Agricultural Pest Survey to ensure that the risk of invasive pests entering the United States is being sufficiently addressed. As stated previously, the required systems approach will allow Dendrobium spp. orchids in approved growing media to be safely imported into the United States from Taiwan.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, without change.

This rule is not an Executive Order 13771 regulatory action because this rule is not significant under Executive Order 12866. Further, APHIS considers this rule to be a deregulatory action under Executive Order 13771 as the action will enable U.S. nurseries that purchase these orchids to benefit from their improved quality and reduced production time in comparison to bare-rooted plants.

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

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the Regulations.gov website (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

Although the importation from Taiwan of bare-rooted Dendrobium spp. orchids is allowed, entry of this orchid genus in growing media is not authorized. In response to requests from the Taiwan Ministry of Agriculture and Forestry, APHIS is amending the regulations to allow the importation of Dendrobium spp. orchids in approved growing media into the United States, subject to specified growing, inspection, and certification requirements.

Orchids are the largest single group of potted flowering plants sold in the United States, and comprised about one-third of sales ($266 million of $788 million) for the potted flowering plants industry in 2014 (most recent data available). Sales of U.S.-produced Dendrobium spp. orchids in 2014 totaled $12.3 million. In 2016, the United States imported 5,948 metric tons (MT) of live orchids valued at $75 million, of which Taiwan supplied 79 percent (orchids valued at over $58.9 million).

The rule will enable Taiwanese exporters to bypass U.S. growers altogether and provide higher-valued, mature potted Dendrobium spp. orchids directly to wholesalers and retailers. However, such a scenario is considered unlikely, given the technical challenges and marketing costs incurred when shipping finished plants in pots. More likely, Taiwan will continue to export immature plants to U.S. nurseries to grow and sell as finished plants.

Import levels will depend on the ability of Taiwanese producers and exporters to cover their production, transportation, and marketing costs given U.S. market prices. U.S. nurseries that purchase Dendrobium spp. orchids will benefit from their improved quality and reduced production time in comparison to bare-rooted plants. The rule will increase competition for U.S. producers and importers of immature Dendrobium spp. orchids.

U.S. orchid producers numbered 158 in 2012, but the number of establishments that are small entities is not known. Given that orchid plants such as Oncidium spp. are already being imported from Taiwan in approved growing media and all orchid species are allowed importation without growing material, we expect that allowing the importation of Dendrobium spp. orchids in approved growing media will not significantly change the volume or value of orchids imported by the United States from Taiwan.

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

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.

An environmental assessment and finding of no significant impact have been prepared for this final rule. The environmental assessment provides a basis for the conclusion that the importation of Dendrobium spp. from Taiwan under the conditions specified in this rule will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The environmental assessment and finding of no significant impact may be viewed on the Regulations.gov website.3 Copies of the environmental assessment and finding of no significant impact are also available for public inspection at USDA, Room 1141, South Building, 14th Street and Independence Avenue SW, Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed under FOR FURTHER INFORMATION CONTACT.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection requirements included in this final rule, which were filed under 0579-0458, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.

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

Accordingly, we are amending 7 CFR part 319 as follows:

Comments Invited

This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we receive and may conduct additional rulemaking based on those comments.

EASA, which is the Technical Agent for the Member States of the European Union, has issued AD No. 2017-0175-E, dated September 13, 2017, to correct an unsafe condition for Leonardo S.p.A. (previously Agusta) Model AB139 and AW139 helicopters. EASA advises of an in-flight loss of an MRB tip cap on an AW139 helicopter where the pilot was able to safely land the helicopter. EASA further advises that an investigation determined the cause as incorrect bonding procedures used during production on MRB part number 3G6210A00131, serial numbers 3615, 3634, 3667, and 3729. According to EASA, this condition could result in loss of an MRB tip cap, increased pilot workload, and reduced control of the helicopter. To address this unsafe condition, the EASA AD requires a one-time inspection of the affected MRB tip caps within 5 hours and replacing the affected MRBs within 10 hours if not replaced as a result of the inspection. The EASA AD also prohibits installing the affected MRBs on a helicopter.

The FAA is in the process of updating Agusta's name change to Leonardo Helicopters on its type certificate. Because this name change is not yet effective, this AD specifies Agusta.

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.

Leonardo Helicopters has issued Emergency Alert Service Bulletin No. 139-508, dated September 12, 2017, which describes procedures for inspecting the tip cap for disbonding using a tap test and replacing the main rotor blade.

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

For helicopters with an MRB part-number (P/N) 3G6210A00131 that has serial number (S/N) 3615, 3634, 3667, or 3729 installed, this AD requires:

• Within 5 hours time-in-service (TIS), tap inspecting each tip cap for disbonding.

• If there is any disbonding, this AD requires, before further flight, removing the MRB from service.

• If there is no disbonding, this AD requires, within 10 hours TIS, removing the MRB from service.

This AD also prohibits installing these serial-numbered MRBs on any helicopter after the effective date of this AD.

The EASA AD requires that you return the removed blades to Leonardo Helicopters, and this AD does not.

We estimate that this AD affects four helicopters of U.S. Registry.

At an average labor rate of $85 per work-hour, we estimate that operators may incur the following costs in order to comply with this AD. Tap inspecting the MRB tip caps will require 1 work-hour, for a cost per helicopter of $85. Replacing one MRB will require 4 work-hours, and $141,725 for required parts. Thus, we estimate a total cost of $568,345 per helicopter and $2,273,380 for the U.S. fleet to comply with this AD.

According to Leonardo Helicopters' service information, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by Leonardo Helicopters. Accordingly, we have included all costs in our cost estimate.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the corrective actions required by this AD must be accomplished within 5 hours TIS.

Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, we find that good cause exists for making this amendment effective in less than 30 days.

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

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

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

For the reasons discussed, I certify that this AD:

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

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

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

We are making a technical correction to Form MSD 1 under the Exchange Act.2

For the reasons set out above, title 17, chapter II of the Code of Federal Regulations is amended as follows:

I. Background

Upon request, FDA has classified the temporary catheter for embolic protection during transcatheter intracardiac procedures as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On September 20, 2016, Claret Medical, Inc., submitted a request for De Novo classification of the Sentinel® Cerebral Protection System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on June 1, 2017, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 870.1251. We have named the generic type of device temporary catheter for embolic protection during transcatheter intracardiac procedures, and it is identified as a single use percutaneous catheter system that has (a) blood filter(s) at the distal end. This device is indicated for use while performing transcatheter intracardiac procedures. The device is used to filter blood in a manner that may prevent embolic material (thrombus/debris) from the transcatheter intracardiac procedure from traveling towards the cerebral circulation.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120; and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:

I. Background

Upon request, FDA has classified the surgical smoke precipitator as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified as, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (see 21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate by means of the procedures for premarket notification under section 510(k) of the FD&C Act and part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act. Section 207 of the Food and Drug Administration Modernization Act of 1997 established the first procedure for De Novo classification (Pub. L. 105-115). Section 607 of the Food and Drug Administration Safety and Innovation Act modified the De Novo application process by adding a second procedure (Pub. L. 112-144). A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a 510(k) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA shall classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application in order to market a substantially equivalent device (see 21 U.S.C. 360c(i), defining “substantial equivalence”). Instead, sponsors can use the less-burdensome 510(k) process, when necessary, to market their device.

On May 26, 2015, Alesi Surgical submitted a request for De Novo classification of the UltravisionTM Visual Field Clearing System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on December 20, 2016, FDA issued an order to the requester classifying the device into class II. FDA is codifying the classification of the device by adding 21 CFR 878.5050. We have named the generic type of device surgical smoke precipitator, and it is identified as a prescription device intended for clearance of the visual field by precipitation of surgical smoke and other aerosolized particulate matter created during laparoscopic surgery.

FDA has identified the following risks to health associated specifically with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this order. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act.

At the time of classification, surgical smoke precipitators are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met (referring to 21 U.S.C. 352(f)(1)).

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

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the guidance document “De Novo Classification Process (Evaluation of Automatic Class III Designation)” have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval, have been approved under OMB control number 0910-0231; the collections of information part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120, and the collections of information in 21 CFR part 801, regarding labeling, have been approved under OMB control number 0910-0485.

On September 30, 2016, the Department published an interim final rule amending 22 CFR part 51, to create a “service passport” that would be used by non-personal services contractors to carry out critical security, maintenance and other functions on behalf of the U.S. government. As noted in the interim final rule, the Department estimates that this rulemaking will affect approximately 1,000 non-personal services contractors per year. Further information concerning the rationale for this rule can be found in the interim final rule.

The Department provided 60 days for the public to comment on this rule. This period expired on November 29, 2016. The Department received no public comments.

The Regulatory Findings included with the interim final rule are incorporated herein. This rule is not an E.O. 13771 regulatory action because it is not significant under E.O. 12866.

Multnomah County, the bridge owner, requested the Broadway Bridge be authorized to open half the span in single leaf mode to make adjustments to newly installed equipment. The Broadway Bridge crosses the Willamette River at mile 11.7, and provides 90 feet of vertical clearance above Columbia River Datum 0.0 while in the closed-to-navigation position, and provides 125 feet of horizontal clearance with half the span open. This bridge operates in accordance with 33 CFR 117.897. This deviation allows the double bascule span of the Broadway Bridge across the Willamette River, mile 11.7, to operate the bridge in single leaf mode to marine traffic. The deviation period will be from 1 a.m. on January 27, 2018 to 11:59 p.m. on February 23, 2018. The bridge shall operate in accordance to 33 CFR 117.897 at all other times.

Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. One particular shipping company regularly requests a full bridge span opening in order to transit the river. In anticipation of this deviation, the shipping company has agreed to give a 7 day notice and a 24 hour notice to the bridge owner for a request of a full bridge span opening. If this procedure is followed, the bridge owner has agreed to comply with these requests.

Vessels able to pass through the bridge in the closed-to-navigation position may do so at anytime. The bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

When Congress enacted the Copyright Act of 1976 (the “Act”), it authorized the Register of Copyrights (the “Register”) to specify by regulation the administrative classes of works for the purpose of seeking a registration, and the nature of the deposits required for each such class. In addition, Congress granted the Register the discretion to allow groups of related works to be registered with one application and one filing fee. See 17 U.S.C. 408(c)(1). Congress cited “the various editions or issues of a daily newspaper” as a specific example of a “group of related works” that would be suitable for a group registration. H.R. Rep. No. 94-1476, at 154 (1976), reprinted in 1976 U.S.C.C.A.N. 5659, 5770; S. Rep. No. 94-473, at 136 (1975).

On November 6, 2017, the Copyright Office (the “Office”) published a notice of proposed rulemaking (“NPRM”) setting forth proposed amendments to the current regulation governing the group registration option for newspapers. 82 FR 51369 (Nov. 6, 2017). The NPRM proposed modifying the requirements for this group registration option in several respects. First, the proposed rule would make any newspaper, as defined in the regulation, eligible for a group registration, regardless of whether the Library of Congress (the “Library”) has selected that newspaper for its collections. Second, it would require applicants to register their newspapers through the Office's electronic registration system in lieu of using paper applications. Third, it would amend the deposit requirements by requiring applicants to upload their newspapers in digital form through the Office's electronic registration system. Applicants would no longer be required to submit microfilm containing a complete copy of each issue (although they could submit microfilm on a voluntary basis, in addition to uploading digital copies) if the microfilm is received by December 31, 2019, after which the microfilm option would be eliminated. Fourth, applicants would be required to submit their claim within three months after the date of publication for the earliest issue in the group, rather than the most recent issue. Fifth, the proposed rule confirmed that deposits submitted for the purpose of group registration would satisfy the mandatory deposit requirement under section 407. Sixth, it confirmed that the Library may provide limited access to any digital newspaper deposits that it receives from the Office under the group registration option, subject to certain restrictions. Seventh, the proposed rule codified the Office's longstanding position regarding the scope of a registration for a group of newspaper issues, namely, that a group registration covers each issue in the group, as well as the articles, photographs, illustrations, or other contributions appearing within each issue—if they are fully owned by the copyright claimant and if they were first published in those issues. Finally, the proposed rule would implement some technical amendments to address certain inconsistencies in the current regulation.

In response to the NPRM, the Office received comments from the News Media Alliance (“NMA”),1 the Copyright Alliance, and three individuals.2 The NMA “strongly supports the Copyright Office's proposal to broaden the eligibility and formatting requirements for group registration of newspapers and to permit the submission of deposits in digital form rather than on microfilm.” NMA Comment at 3. The Copyright Alliance endorsed NMA's comments and “joins in applauding the Copyright Office for its proposal permitting broader group registration for newspapers and accepting deposits in PDF format rather than microfilm.” Copyright Alliance Comment at 1. Of the individuals submitting comments, one expressed support for the proposed rule, one provided non-substantive comments, and one expressed concern about charging a filing fee.3

Having reviewed and carefully considered the comments, the Office now issues a final rule that is almost substantively identical to the proposed rule.4 The NPRM stated that the Office will allow applicants to submit microfilm copies in addition to uploading digital copies (if the microfilm is received by December 31, 2019) in case publishers need time to develop quality assurance testing to ensure complete digital submissions. For avoidance of doubt, the final rule clarifies that microfilm copies may be used to cure deficiencies in the digital files at the Register's discretion. The final rule also clarifies that the microfilm copies must be submitted at the same time as the application, but the effective date of registration for this group option will be the date on which the Office receives an acceptable application, the digital files, and the proper filing fee.

The NMA asked the Office to clarify when the final rule will go into effect. As stated above, the final rule takes effect on March 1, 2018. Under the final rule, applicants will be required to submit their claims within three months after the date of publication for the earliest issue in the group. Thus, the final rule may be used to register newspaper issues published on or after December 1, 2017, provided that the claim is received in a timely manner.5 Because applicants will be required to include a full month of issues in each claim, and because they will be required to submit their claims within three months after the publication of the earliest issue in the group (rather than the most recent issue), it makes sense for the final rule to go into effect on the first day of March 2018.

The NMA also asked the Office to provide more information on what publishers will be expected to do when the final rule goes into effect. The Office is developing several new resources in response to this request. The Office will prepare a video tutorial explaining how to complete the application for the group registration option for newspapers, as well as revise the “help text” within the application itself to reflect the new registration requirements. In addition, the Office will update its various circulars discussing the Office's practices and procedures for this group registration option, and the Office intends to make similar changes to the sections of the Compendium of U.S. Copyright Office Practices, Third Edition that discuss this option.

For the reasons set forth in the preamble, the Copyright Office amends 37 CFR parts 201 and 202 as follows:

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

The Social Security Act (the Act) provides the Secretary with tools and resources to combat fraud, waste, and abuse in Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). In particular, section 1866(j)(7) of the Act provides the Secretary with authority to impose a temporary moratorium on the enrollment of new Medicare, Medicaid, or CHIP providers and suppliers, including categories of providers and suppliers, if the Secretary determines a moratorium is necessary to prevent or combat fraud, waste, or abuse under these programs. Regarding Medicaid, section 1902(kk)(4) of the Act requires States to comply with any moratorium imposed by the Secretary unless the State determines that the imposition of such moratorium would adversely impact Medicaid beneficiaries' access to care. In addition, section 2107(e)(1)(F) of the Act provides that the Medicaid provision in section 1902(kk) of the Act is also applicable to CHIP.

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

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

Based on this authority and our regulations at § 424.570, we initially imposed moratoria to prevent enrollment of new home health agencies, subunits, and branch locations 1 (hereafter referred to as HHAs) in Miami-Dade County, Florida and Cook County, Illinois, as well as surrounding counties, and Medicare Part B ground ambulance suppliers in Harris County, Texas and surrounding counties, in a notice issued on July 31, 2013 (78 FR 46339).2 We exercised this authority again in a notice published on February 4, 2014 (79 FR 6475) when we extended the existing moratoria for an additional 6 months and expanded them to include enrollment of HHAs in Broward County, Florida; Dallas County, Texas; Harris County, Texas; and Wayne County, Michigan and surrounding counties, and enrollment of ground ambulance suppliers in Philadelphia, Pennsylvania and surrounding counties. Then, we further extended these moratoria in documents issued on August 1, 2014 (79 FR 44702), February 2, 2015 (80 FR 5551), July 28, 2015 (80 FR 44967), and February 2, 2016 (81 FR 5444). On August 3, 2016 (81 FR 51120), we extended the current moratoria for an additional 6 months and expanded them to statewide for the enrollment of new HHAs in Florida, Illinois, Michigan, and Texas, and Part B non-emergency ambulance suppliers in New Jersey, Pennsylvania, and Texas. Our August 3, 2016 publication also announced the lifting of temporary moratoria for all Part B emergency ambulance suppliers.3 On January 9, 2017 (82 FR 2363) and July 28, 2017 (82 FR 35122), CMS again issued a document to extend the temporary moratoria for a period of 6 months. On September 1, 2017, CMS lifted the statewide temporary moratorium on the enrollment of new Medicare Part B non-emergency ground ambulance suppliers in Texas under the authority of § 424.570(d). This lifting of the moratorium also applied to Medicaid and CHIP in Texas. This decision was a result of the Presidential Disaster Declaration signed on August 25, 2017 for several counties in the State of Texas due to Hurricane Harvey. Upon declaration of the disaster, CMS carefully reviewed the potential impact of continued moratoria in Texas, and decided to lift the temporary enrollment moratorium on non-emergency ground ambulance suppliers in Texas in order to aid in the disaster response. CMS published a formal announcement of this decision on November 3, 2017 (82 FR 51274).

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

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

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

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

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

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

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

Under § 424.570(a)(1)(iii), a temporary moratorium does not apply to any of the following: (1) Changes in practice location (2) changes in provider or supplier information, such as phone number or address; or (3) changes in ownership (except changes in ownership of HHAs that require initial enrollment under § 424.550). Also, in accordance with § 424.570(a)(1)(iv), a temporary moratorium does not apply to any enrollment application that a Medicare contractor has already approved, but has not yet entered into the Provider Enrollment, Chain, and Ownership System (PECOS) at the time the moratorium is imposed.

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

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

Once a moratorium is lifted, the provider or supplier types that were unable to enroll because of the moratorium will be designated to the “high” screening level in accordance with §§ 424.518(c)(3)(iii) and 455.450(e)(2) if such provider or supplier applies at any time within 6 months from the date the moratorium was lifted.

CMS currently has in place statewide moratoria on newly enrolling HHAs in Florida, Illinois, Michigan, and Texas and Part B non-emergency ambulance suppliers in New Jersey and Pennsylvania. Under section 1932(d)(6)(A) of the Act, network providers in a Medicaid managed care organization are required to enroll with the State Medicaid agency no later than January 1, 2018. For purposes of these moratoria, providers that were participating as network providers in one or more managed care organizations before January 1, 2018 will not be considered “newly enrolling” when they are required to enroll with the State under this statutory requirement; and thus will not be subject to the moratoria.

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

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

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

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

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

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

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

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

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major regulatory actions with economically significant effects ($100 million or more in any 1 year). This document will prevent the enrollment of new home health providers and Part B non-emergency ground ambulance suppliers in Medicare, Medicaid, and CHIP in certain states. Though savings may accrue by denying enrollments, the monetary amount cannot be quantified. Since the imposition of the initial moratoria on July 31, 2013, more than 1187 HHAs and 24 ambulance companies in all geographic areas affected by the moratoria had their applications denied. We have found the number of applications that are denied after 60 days declines dramatically, as most providers and suppliers will not submit applications during the moratoria period. Therefore, this document does not reach the economic threshold, and thus is not considered a major action.

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

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

Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any regulatory action whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2017, that threshold is approximately $148 million. This document will have no consequential effect on state, local, or tribal governments or on the private sector.

Executive Order 13771, titled “Reducing Regulation and Controlling Regulatory Costs,” was issued on January 30, 2017 (82 FR 9339, February 3, 2017). It has been determined that this notice is a transfer notice that does not impose more than de minimis costs and thus is not a regulatory action for the purposes of E.O. 13771.

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

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

I. Background

On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74) (“the Act”). The Act requires Federal agencies to adjust the level of civil monetary penalties with an initial “catch-up” adjustment through rulemaking and then make subsequent annual adjustments for inflation no later than January 15 of each year.

The Office of Management and Budget (OMB) recently issued guidance to assist Federal agencies in implementing the annual adjustments required by the Act which agencies must complete by January 15, 2018. See December 15, 2017, Memorandum for the Heads of Executive Departments and Agencies, from Mick Mulvaney, Director, Office of Management and Budget, re: Implementation of Penalty Inflation Adjustments for 2018, Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (M-18-03). The guidance states that the cost-of-living adjustment multiplier for 2018, based on the Consumer Price Index (CPI-U) for the month of October 2017, not seasonally adjusted, is 1.02041. (The annual inflation adjustments are based on the percent change between the October CPI-U preceding the date of the adjustment, and the prior year's October CPI-U.) The guidance instructs agencies to complete the 2018 annual adjustment by multiplying each applicable penalty by the multiplier, 1.02041, and rounding to the nearest dollar. Further, the guidance instructs agencies to apply the multiplier to the most recent penalty amount that includes the catch-up adjustment required by the Act.

The annual adjustment applies to all civil monetary penalties with a dollar amount that are subject to the Act. A civil monetary penalty is any assessment with a dollar amount that is levied for a violation of a Federal civil statute or regulation, and is assessed or enforceable through a civil action in Federal court or an administrative proceeding. A civil monetary penalty does not include a penalty levied for violation of a criminal statute, or fees for services, licenses, permits, or other regulatory review. This final rule adjusts the following civil monetary penalties contained in the Department regulations implementing the Native American Graves Protection and Repatriation Act (NAGPRA) for 2018 by multiplying 1.02041 by each penalty amount as updated by the catch-up adjustment made in 2017:

Consistent with the Act, the adjusted penalty levels for 2018 will take effect immediately upon the effective date of the adjustment. The adjusted penalty levels for 2018 will apply to penalties assessed after that date including, if consistent with agency policy, assessments associated with violations that occurred on or after November 2, 2015. The Act does not, however, change previously assessed penalties that the Department is collecting or has collected. Nor does the Act change an agency's existing statutory authorities to adjust penalties.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.

Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.

This rule is not subject to E.O. 13771 because it is neither a significant regulatory action as defined in Section 3(f) of E.O. 12866 or a deregulatory action under E.O. 13771.

The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule. See 5 U.S.C. 603(a) and 604(a). The RFA does not apply to this final rule because the Office of the Secretary is not required to publish a proposed rule for the reasons explained below in Section III.M.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:

(a) Does not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This rule does not impose an unfunded mandate on State, local, or tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq.) is not required.

This rule does not effect a taking of private property or otherwise have taking implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.

This rule complies with the requirements of E.O. 12988. Specifically, this rule:

(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required.

This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) is not required. We may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rule is covered by a categorical exclusion. This rule is excluded from the requirement to prepare a detailed statement because it is a regulation of an administrative nature. (For further information see 43 CFR 46.210(i).) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects is not required.

The Act requires agencies to publish annual inflation adjustments by no later than January 15, 2018 and by no later than January 15 each subsequent year, notwithstanding section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553). OMB has interpreted this direction to mean that the usual APA public procedure for rulemaking—which includes public notice of a proposed rule, an opportunity for public comment, and a delay in the effective date of a final rule—is not required when agencies issue regulations to implement the annual adjustments to civil penalties that the Act requires. Accordingly, we are issuing the 2018 annual adjustments as a final rule without prior notice or an opportunity for comment and with an effective date immediately upon publication in the Federal Register.

For the reasons given in the preamble, the Office of the Secretary amends 43 CFR part 10 as follows:

This document contains correcting amendments to the Code of Federal Regulations to correct an erroneous date introduced in a Federal Register document published June 2, 2017 (82 FR 25535). A prior attempt to correct that date through a document published July 14, 2017 (82 FR 32489) was unsuccessful.

For the reasons discussed in the preamble, the Federal Communications Commission corrects 47 CFR part 36 by making the following correcting amendments:

Background

On September 21, 2015, we received a petition from Defenders of Wildlife to list the oceanic whitetip shark (Carcharhinus longimanus) as threatened or endangered under the ESA throughout its entire range, or alternatively, to list two distinct population segments (DPSs) of the oceanic whitetip shark, as described in the petition, as threatened or endangered, and to designate critical habitat. We found that the petitioned action may be warranted for the species; and, on January 12, 2016, we published a positive 90-day finding for the oceanic whitetip shark (81 FR 1376), announcing that the petition presented substantial scientific or commercial information indicating the petitioned action may be warranted range wide, and explaining the basis for the finding. We also announced the initiation of a status review of the species, as required by section 4(b)(3)(a) of the ESA, and requested information to inform the agency's decision on whether the species warranted listing as endangered or threatened under the ESA. On December 29, 2016, we published a proposed rule to list the oceanic whitetip shark as threatened (81 FR 96304). We requested public comments on the information in the proposed rule and associated status review during a 90-day public comment period, which closed on March 29, 2017. This final rule provides a discussion of the public comments received in response to the proposed rule and our final determination on the petition to list the oceanic whitetip shark under the ESA.

We are responsible for determining whether species meet the definition of threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). To make this determination, we first consider whether a group of organisms constitutes a “species” under the ESA, then whether the status of the species qualifies it for listing as either threatened or endangered. Section 3 of the ESA defines a “species” to include any subspecies of fish or wildlife or plants, and any distinct population segment of any species of vertebrate fish or wildlife, which interbreeds when mature. The oceanic whitetip shark is a formally recognized species with no taxonomic uncertainty and thus meets the ESA definition of a “species.”

Section 3 of the ESA defines an endangered species as any species which is in danger of extinction throughout all or a significant portion of its range and a threatened species as one which is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. We interpret an “endangered species” to be one that is presently in danger of extinction. A “threatened species,” on the other hand, is not presently in danger of extinction, but is likely to become so in the foreseeable future (that is, at a later time). In other words, the primary statutory difference between a threatened species and endangered species is the timing of when a species may be in danger of extinction, either presently (endangered) or in the foreseeable future (threatened).

When we consider whether a species might qualify as threatened under the ESA, we must consider the meaning of the term “foreseeable future.” It is appropriate to interpret “foreseeable future” as the horizon over which predictions about the conservation status of the species can be reasonably relied upon. The foreseeable future considers the life history of the species, habitat characteristics, availability of data, particular threats, ability to predict threats, and the reliability to forecast the effects of these threats and future events on the status of the species under consideration. Because a species may be susceptible to a variety of threats for which different data are available regarding the species' response to that threat, or which operate across different time scales, the foreseeable future is not necessarily reducible to a particular number of years.

Section 4(a)(1) of the ESA requires us to determine whether any species is endangered or threatened due to any one or a combination of the following five threat factors: the present or threatened destruction, modification, or curtailment of its habitat or range; overutilization for commercial, recreational, scientific, or educational purposes; disease or predation; the inadequacy of existing regulatory mechanisms; or other natural or manmade factors affecting its continued existence. We are also required to make listing determinations based solely on the best scientific and commercial data available, after conducting a review of the species' status and after taking into account efforts being made by any state or foreign nation to protect the species.

In assessing the extinction risk of the oceanic whitetip shark, we considered demographic risk factors, such as those developed by McElhany et al. (2000), to organize and evaluate the forms of risks. The approach of considering demographic risk factors to help frame the consideration of extinction risk has been used in many of our previous status reviews (see http://www.nmfs.noaa.gov/pr/species for links to these reviews). In this approach, the collective condition of individual populations is considered at the species level according to four demographic viability factors: abundance and trends, population growth rate or productivity, spatial structure and connectivity, and genetic diversity. These viability factors reflect concepts that are well-founded in conservation biology and that individually and collectively provide strong indicators of extinction risk.

Scientific conclusions about the overall risk of extinction faced by the oceanic whitetip shark under present conditions and in the foreseeable future are based on our evaluation of the species' demographic risks and section 4(a)(1) threat factors. Our assessment of overall extinction risk considered the likelihood and contribution of each particular factor, synergies among contributing factors, and the cumulative impact of all demographic risks and threats on the species.

Section 4(b)(1)(A) of the ESA requires the Secretary, when making a listing determination for a species, to take into consideration those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect the species. Therefore, prior to making a listing determination, we also assess such protective efforts to determine if they are adequate to mitigate the existing threats.

In response to our request for comments on the proposed rule, we received a total of 356 comments. Comments were submitted by multiple organizations and individual members of the public from a minimum of 19 countries (Australia, Brazil, Canada, Costa Rica, Ecuador, Egypt, England, Guatemala, India, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, South Africa, St. Kitts and Nevis, Sweden, and the United States). Most of the comments were supportive of the proposed listing of the oceanic whitetip shark as threatened. A few commenters argued that the oceanic whitetip should be listed as endangered, and some commenters were opposed to the proposed listing of the oceanic whitetip shark altogether. We have considered all public comments, and we provide responses to all relevant issues raised by comments. We have not responded to comments outside the scope of this rulemaking, such as comments regarding the potential economic impacts of ESA listings, comments suggesting that certain types of activities be covered or excluded in any future regulations pursuant to ESA section 4(d) for threatened species, or comments suggesting the ESA is not the appropriate tool for conserving the oceanic whitetip shark. Summaries of comments received regarding the proposed rule and our responses are provided below.

Comment 1: We received numerous comments that support the proposed listing of the oceanic whitetip shark as a threatened species under the ESA. A large majority of the comments were comprised of general statements expressing support for listing the oceanic whitetip shark as threatened under the ESA and were not accompanied by substantive information or references. Some of the comments were accompanied by information that is consistent with, or cited directly from, our proposed rule or draft status review report, including the observed population declines of the species, its prevalence in the international trade of shark fins, and the inadequacy of existing regulations to protect the species. Many comments also noted the importance of sharks as apex predators and their role in maintaining the balance of marine ecosystems. We also received two letters of support for our proposed rule to list the oceanic whitetip shark under the ESA that were accompanied by thousands of signatures: one letter had 3,306 signatures and the other had 24,020 signatures.

Response: We acknowledge the numerous comments and the considerable public interest expressed in support of the conservation of the oceanic whitetip shark.

Comment 2: We received several comments that disagreed with our proposed listing determination of threatened for the oceanic whitetip shark, and argued that the species should be listed as endangered instead for a variety of reasons. One commenter noted that the species should be listed as endangered (as opposed to threatened) because the species' stock is “much lower than accounted for in the finding.” Another commenter wrote that global warming, pollution (including increasing volumes of trash and plastic) and lack of genetic diversity all contribute to an endangered status. This particular commenter also disagreed that persistence at diminished abundance levels justifies a threatened listing, alleging that we characterized population declines of 70-80 percent as “reasonable.” Other commenters stated that while they agreed with us that the oceanic whitetip shark warrants listing under the ESA, they believe the best available scientific and commercial information indicates that the species warrants listing as endangered as opposed to threatened due to inadequate regulatory mechanisms. One commenter provided a substantive discussion of several regulatory mechanisms in the Eastern Pacific that were deemed inadequate (see Comment 11 below for a detailed summary and response). Another commenter asserted that the species is endangered because past regulatory efforts to protect sharks have been unsuccessful in the United States (e.g., Magnuson-Stevens Fishery Conservation and Management Act (MSA), Shark Finning Prohibition Act of 2000, and Shark Conservation Act of 2010). Other commenters noted that if the oceanic whitetip shark is likely going to be endangered in the foreseeable future, we should use a precautionary approach and list it as endangered now. Finally, a few commenters noted that listing the oceanic whitetip as threatened would not suffice to protect the species, and asserted that we can only promulgate take prohibitions for species that are listed as endangered.

Response: We disagree with commenters that the oceanic whitetip shark should be listed as endangered. As explained in the proposed rule, there are several reasons why the oceanic whitetip shark does not meet the definition of an endangered species under the ESA. The oceanic whitetip shark is a globally distributed species that has not undergone any range contraction or experienced population extirpations in any portion of its range despite heavy harvest bycatch. Given that local extirpations are often a precursor to extinction events range wide, we consider this one indication that the species is not presently in danger of extinction. We could also not find any evidence to suggest that the threats of global warming or plastic pollution are having negative population-level effects on this species and the commenter provided no substantive information to support their claim that these are operative threats on the species. With regard to the species' low genetic diversity, we addressed this threat in detail in the status review report and proposed rule. We explained that the Extinction Risk Analysis (ERA) team acknowledged the low genetic diversity of the species and concluded that it did not, in and of itself, necessarily equate to a risk of extinction, but when combined with the low levels of abundance and continued exploitation, it could pose a viable risk in the foreseeable future. In terms of oceanic whitetip shark abundance, we did not receive any information to suggest that the species' abundance is lower than what we accounted for in our status review report and proposed rule. We also never characterized this species' population declines as “reasonable;” in fact, the species' historical and ongoing declining trends in abundance is one of the major demographic risks we identified for the oceanic whitetip that led to our proposed determination of threatened for the species. However, based on analyses of fisheries observer data conducted by the ERA team and presented in the status review report (Young et al., 2017), the oceanic whitetip shark is showing stabilizing trends in abundance in a couple of areas, including the Northwest Atlantic and Hawaii. We concluded that these trends are likely attributable to U.S. fisheries management plans and species-specific regulations that have been in place for the oceanic whitetip for several years and will likely help maintain these trends in the near-term. Additionally, with respect to the adequacy of regulatory mechanisms, we concluded that the increase in species-specific regulatory mechanisms that prohibit the species in numerous fisheries throughout its range should help to reduce fisheries-related mortality and slow (but not necessarily halt) population declines to some degree, thus providing a temporal buffer in terms of the species' extinction risk. As such, we cannot conclude that the species is presently in danger of extinction throughout all or a significant portion of its range; rather, we maintain that the species is likely to become endangered throughout all or a significant portion of its range in the foreseeable future, and thus meets the statutory definition of a threatened species under the ESA.

With regard to comments about using a precautionary approach when making a listing determination, we are only able to consider the best available scientific and commercial information to determine whether the species meets the definition of a threatened or endangered species under the ESA. Therefore, we are unable to utilize a precautionary approach and list a species as endangered when it does not meet the statutory definition of an endangered species at the time of listing.

Finally, commenters are incorrect in their statements that only endangered species are afforded protections under the ESA in the form of take prohibitions. While it is true that only endangered species receive automatic protections under section 9 of the ESA at the time of listing, we have the discretion and ability to promulgate 4(d) regulations for threatened species to apply any or all of the same protections for threatened species, should we find them necessary and advisable for the conservation of the species.

Comment 3: In contrast to Comment 2 above, we also received a comment supporting our determination that the oceanic whitetip shark does not qualify as an endangered species. The commenter stated that the information in the proposed rule clearly does not support a conclusion that the species is presently “on the brink of extinction” and requested that we provide a more detailed explanation in our final decision as to why the oceanic whitetip shark does not qualify as an endangered species.

Response: Although we disagree with the interpretation of endangered as being equivalent to “on the brink of extinction,” we do agree with the commenter regarding our determination that the oceanic whitetip shark is not presently in danger of extinction throughout its range (i.e., endangered). We explain our final decision regarding the listing status of the oceanic whitetip shark in our response to Comment 2 above and in the Final Listing Determination section below.

Comment 4: One commenter asserted that we did not conduct the required analysis to determine that the oceanic whitetip shark is currently threatened. The commenter stated that although we provided a comprehensive summary of the present status of the oceanic whitetip shark, we did not provide an adequate analysis of the expected status of the species at the end of the foreseeable future. In other words, the commenter contends that we did not properly analyze whether, how, when and to what degree the identified threats will affect the species' status by the end of the foreseeable future (i.e., 30 years). The commenter also asserted that our reliance on the Extinction Risk Analysis (ERA) team's assessment is flawed because there were mixed results regarding the species' overall extinction risk (e.g., 20 out of 60 likelihood points were allocated to the “low risk” category; 34 out of 60 likelihood points were allocated to the “moderate risk” category; and 6 out of 60 likelihood points were allocated to the “high risk” category). The commenter concluded that we did not consider the factors relevant to our decision nor make a rational connection between the facts and our determination.

Response: We disagree with the commenter's characterization of our extinction risk analysis. With regard to the ERA team's methods and conclusions, the available data for the oceanic whitetip shark did not allow for a quantitative analysis or model of extinction risk into the foreseeable future. Therefore, the ERA team adopted the “likelihood point” (i.e., FEMAT; Forest Ecosystem Management Assessment Team 1993) method for ranking the overall risk of extinction to allow individuals to express uncertainty. As explained in the proposed rule, this method has been used in previous NMFS status reviews (e.g., Pacific salmon, Southern Resident killer whale, Puget Sound rockfish, Pacific herring, and black abalone) to structure the team's thinking and express levels of uncertainty when assigning risk categories. Therefore, while the ERA team distributed their likelihood points among all three risk categories to express some level of uncertainty, more than half of the available likelihood points were allocated to the “moderate risk” category. The ERA team's scientific conclusions about the overall risk of extinction faced by the oceanic whitetip shark is based on an evaluation of current demographic risks and identified threats to the species, and how these factors will likely impact the trajectory of the species into the foreseeable future. As noted in the proposed rule, the ERA team determined that due to significant and ongoing threats of overutilization and largely inadequate regulatory mechanisms, current trends in the species' abundance, productivity and genetic diversity place the species on a trajectory towards a high risk of extinction in the foreseeable future. In other words, given the likely continuation of present-day conditions over the next 30 years or so, the oceanic whitetip will more likely than not be at or near a level of abundance, productivity, and/or diversity that places its continued persistence in question, and may be strongly influenced by stochastic or depensatory processes. Therefore, while we were unable to quantify or model the expected condition of the species at the end of the foreseeable future, we thoroughly evaluated the best available scientific information regarding the species' current demographic risks and threats and made rational conclusions regarding the species' trajectory over the next 30 years based on the ERA team's expertise and professional judgement regarding the species, its threats, and fisheries management.

We received a few comments suggesting that we identify distinct population segments of the oceanic whitetip shark.

Comment 5: One group of commenters disagreed with the proposed global listing of the oceanic whitetip shark as a threatened species. The commenters asserted that we failed to reach conclusions regarding recent genetic studies discussed in the status review and proposed rule (Ruck 2016 and Camargo et al., 2016), which they argue supports the identification of at least two DPSs. They provided further discussion of theories proposed by Ruck (2016) and Camargo et al. (2016) that population structure may reflect thermal barriers and female philopatry. As such, they requested that we re-assess the extinction risk of the species following a thorough analysis of potential distinct population segments (DPSs), specifically the Atlantic and Indo-Pacific populations, because the commenters believe that extinction risk analyses of these individual DPSs may result in a different listing determination. The commenters asserted that “Even when listing is warranted for the global species, NMFS has a duty to analyze potential DPSs.” The commenter also stated that conducting an extinction risk analysis at the DPS level (as opposed to the global level) would be “more meaningful and scientifically relevant for the oceanic whitetip shark's future management, including critical habitat designation and recovery planning strategies.”

Response: We disagree with the commenters regarding our duty to analyze potential DPSs after finding the species warrants listing range-wide. The petition we received from Defenders of Wildlife clearly requested that we list the oceanic whitetip shark as threatened or endangered throughout its range. As an alternative to a global listing, the petition requested that if we found that there are DPSs of oceanic whitetips (specifically Indo-Pacific and Atlantic populations), that those DPSs be listed under the ESA. At the 90-day finding stage, we determined that the petition presented substantial scientific or commercial information indicating listing may be warranted for the oceanic whitetip shark range-wide, and therefore, we initiated the status review on the global population (81 FR 1376, January 12, 2016). We specifically explained in the 90-day finding that if after this review we determined that the species did not warrant listing range-wide, then we would consider whether the populations requested by the petition qualify as DPSs and warrant listing. We concluded that the oceanic whitetip shark warrants listing as a threatened species throughout its range. As such, we have discretion as to whether we should divide a species into DPSs, and the commenter is incorrect that we are required to commit additional agency resources to conduct an analysis and break up the species into the smallest listable entity (i.e., DPSs) despite a warranted listing for the species globally. Nonetheless, we re-reviewed the two available genetic studies for the species (Ruck 2016 and Camargo et al., 2016), particularly in regards to discreteness between Atlantic and Indo-Pacific subpopulations. These studies differ in genetic markers and sampling locations, but neither provides strong evidence for genetic discontinuity. Camargo et al. (2016) compared mitochondrial DNA sequences of samples collected in eight locations, including the southeast Atlantic and the southwest Indian Oceans (i.e., on either side of the southern tip of Africa). They concluded there was an absence of genetic structure between the East Atlantic and Indian Ocean subpopulations. Though the Indian Ocean sample size was small (n=9), it included four haplotypes, all of which were also found in Atlantic Ocean subpopulations. Camargo et al. (2016) explained that this genetic connectivity (i.e., the existence of only one genetic stock around the African continent) may be facilitated by the warm Agulhas current, which passes under the Cape of Good Hope of South Africa and may transport oceanic whitetips from the Indian Ocean to the eastern Atlantic. Ruck (2016) compared longer mitochondrial DNA sequences and 11 microsatellite DNA loci of samples collected in seven locations; however, there were no samples from the southeast Atlantic and the southwest Indian Oceans (i.e., the closest sampling locations were Brazil and Arabian Sea). Ruck (2016) found weak but statistically significant differentiation between West Atlantic and Indo-Pacific subpopulations but explained that her study shows genetic evidence for contemporary migration between the West Atlantic and Indo-Pacific as a result of semi-permeable thermal barriers (i.e., the warm Agulhas current). Thus, we compare one study which may lack resolution but demonstrates genetic connectivity between the southeast Atlantic and the southwest Indian Ocean subpopulations (i.e., across the Agulhas current; Camargo et al., 2016) to another that finds weak genetic structure and low-level contemporary migration across great distances (i.e., the West Atlantic and the northern Indian Ocean; Ruck 2016). We conclude that neither study provides unequivocal evidence for genetic discontinuity or marked separation (i.e., discreteness) between Atlantic and Indo-Pacific Ocean subpopulations. Therefore, the best available data do not support the identification of these populations as DPSs.

Overall, given the ambiguous nature of the genetics data, limited information regarding the movements of oceanic whitetip sharks, and our discretion to identify DPSs, we do not find cause nor are we required to break up the global population into DPSs. We also do not agree that breaking the global population up into two DPSs would enhance conservation of the species under the ESA. For a threatened species, we have the discretion to promulgate ESA section 4(d) regulations that can be tailored for specific populations and threats should we find it necessary and advisable for the conservation of the species. Recovery planning can also be tailored for the species in different parts of its range.

Comment 6: Another commenter also urged us to break up the global population into DPSs due to differences in regulatory mechanisms and management, specifically between the Northwest Atlantic and South Atlantic. The commenter argued that while regulatory measures in U.S. fisheries operating in the Northwest Atlantic are adequate for the oceanic whitetip, regulations for other fishing fleets in the South Atlantic (particularly Brazil) are likely inadequate. Therefore, the commenter asserted that oceanic whitetip sharks occurring in U.S. waters of the Northwest Atlantic should be identified as a DPS, such that the Northwest Atlantic population would not qualify as a threatened species.

Response: We disagree with the commenter's interpretation of the DPS Policy and its intent. As noted previously, we have discretion with regard to listing DPSs in the case of the oceanic whitetip shark, and Congress has indicated that the provision to list DPSs should be used sparingly. Furthermore, the DPS Policy (61 FR 4722, February 7, 1996) identifies two specific criteria that populations must meet in order to be listed as a DPS—discreteness and significance; and while management differences may be considered in our analysis, management differences are not a sufficient basis for delineating populations as DPSs. Additionally, in many cases recognition of DPSs can unduly complicate species management rather than further the conservation purposes of the statute. In this case, we could find no overriding conservation benefit to break up the global species into DPSs. Finally, as explained in the status review and proposed rule (Young et al., 2017; 81 FR 96304), despite the stabilizing trend in its current state, the Northwest Atlantic population represents a very small portion of the range of the species and is likely persisting at a diminished abundance, particularly given the common abundance documented historically for the oceanic whitetip in this part of its range. With no clear indication of population recovery to date, we still have some concern for the species in this part of its range. Therefore, given the species warrants listing as threatened throughout its range, we do not find cause to break up the population into smaller units.

Comment 7: One commenter asserted that the status review and proposed rule failed to analyze whether any particular regions of the oceanic whitetip shark's range qualify as significant portions of the species' range (SPR) under the SPR Policy. The commenter contended that had we conducted analyses of potential SPRs, we may have determined that oceanic whitetip sharks in a particular ocean basin (e.g., Atlantic and Pacific) or regions within an ocean basin (e.g., eastern and western Atlantic) face different levels of extinction risk and would result in a likely change of listing determination for the oceanic whitetip shark.

Response: We disagree with the commenter's interpretation of the SPR Policy (79 FR 37577, July 1, 2014), as well as their statement that we failed to analyze whether there are any portions of the oceanic whitetip shark's range that would qualify as an SPR, which implies we were required to do so. We believe Congress intended that, where the best available information allows the Services to determine a status for the species rangewide, such listing determination should be given conclusive weight. A rangewide determination of status more accurately reflects the species' degree of imperilment, and assigning such status to the species (rather than potentially assigning a different status based on a review of only a portion of the range) best implements the statutory distinction between threatened and endangered species. Maintaining this fundamental distinction is important for ensuring that conservation resources are allocated toward species according to their actual level of risk. We also note that Congress placed the “all” language before the “significant portion of its range” phrase in the definitions of “endangered species” and “threatened species.” This suggests that Congress intended that an analysis based on consideration of the entire range should receive primary focus, and thus that the agencies should do a “significant portion of its range” analysis as an alternative to a rangewide analysis only if necessary. Under this reading, we should first consider whether listing is appropriate based on a rangewide analysis and proceed to conduct a “significant portion of its range” analysis if (and only if) a species does not qualify for listing as either endangered or threatened according to the “all” language. We note that this interpretation is also consistent with the 2014 Final Policy on Interpretation of the Phrase “Significant Portion of its Range” (79 FR 37578 (July 1, 2014)), which provides that a portion of a species' range can be “significant” only if the species is not currently endangered or threatened throughout all of its range. The current SPR Policy defines “significant” as follows: “A portion of the range of a species is `significant' if the species is not currently endangered or threatened throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range” (79 FR 37578, July 1, 2014). For all of these reasons and based on the SPR Policy, because we determined the oceanic whitetip shark is currently threatened throughout all of its range, we did not conduct an additional SPR analysis to determine if a portion of the species' range is significant and whether the species is endangered in that portion.

Comment 8: We received a comment letter that articulated concern for an omission of information regarding various NMFS time/area seasonal closures for pelagic longline (PLL) gear in the United States Exclusive Economic Zone (EEZ) that have been in place for many years along the East Coast. The commenter asserted that these closures have resulted in a reduction of oceanic whitetip shark bycatch, and this information should have been included in the status review report as an example of management that has benefited the species.

Response: We acknowledge that the status review report did not specifically discuss the time/area seasonal closures for PLL gear in the U.S. EEZ along certain sections of the East Coast. We have since incorporated this information into the status review report. However, the commenter did not provide any details or data to show how these particular regulations have reduced oceanic whitetip shark bycatch in particular, and we are not aware of any scientific study or data that demonstrates the impacts of these closures on oceanic whitetip shark abundance. We agree that it's possible these particular regulations may have had a positive effect on reducing bycatch of oceanic whitetip shark in the Northwest Atlantic PLL fishery, particularly given the stabilizing trend shown by the ERA team's analysis of observer data from the fishery (which cover the aforementioned time/area seasonal closures), but there's no way to confirm this assertion based on the available data and information. Overall, as we explained in the status review report and proposed rule, we do agree that regulatory mechanisms in the Northwest Atlantic have likely improved the status of the oceanic whitetip shark in this portion of its range; however, the incorporation of this new information does not alter our overall assessment of the species' extinction risk throughout its global range.

Comment 9: We received a comment letter from the Blue Water Fishermen's Association that disagreed with our conclusion that inadequate regulatory mechanisms are contributing to an increased risk of extinction for the species, and thus, our decision to list the species as threatened. The substance of the comment focused on regulatory mechanisms implemented for U.S. fishing vessels in the Northwest Atlantic, and asserted that these measures adequately reduce bycatch-related mortality and protect the species from fishing pressure, thus rendering the impacts of U.S. fisheries to the oceanic whitetip shark negligible. The commenter also asserted that the relevant Regional Fishery Management Organizations (RFMOs) have taken adequate measures to protect the species globally by implementing measures to prohibit the retention of oceanic whitetip sharks in the fisheries over which they have competence. The commenter concluded that global regulations of both fisheries and trade (including the Convention on International Trade of Endangered Species of Wild Fauna and Flora (CITES)) are adequate to protect the oceanic whitetip shark, and therefore, the species does not warrant listing under the ESA.

Response: As discussed previously in the response to Comment 8 above, we agree that regulatory mechanisms implemented in the Northwest Atlantic for the U.S. PLL fishery have likely contributed to the stabilization of the oceanic whitetip shark population in this portion of its range. We also agree that the no-retention measures implemented by the relevant RFMOs will also likely help reduce fisheries-related mortality of the species to some degree, when adequately enforced. Although there is arguably high compliance with, and adequate enforcement of, U.S. fisheries regulations, the oceanic whitetip shark is a highly migratory species and thus a shared resource across the Atlantic Ocean basin. Several other pelagic longline fleets impact the species, many of which have poor compliance with and enforcement of fisheries regulations. As such, U.S. regulatory mechanisms have limited impact on the global stage in that they only provide protections to oceanic whitetip sharks while in U.S. waters. While this does not make U.S. regulations inadequate in terms of their purpose of protecting oceanic whitetip sharks while in U.S. waters, regulations are likely inadequate in other parts of the world to prevent further population declines of oceanic whitetip as a result of overutilization. For example, we explained in the status review report and proposed rule that Brazil, which is the top oceanic whitetip catching country in the Atlantic, has poor enforcement of its fisheries regulations to mitigate the significant fishing pressure on oceanic whitetip sharks in the region. In fact, a recent review paper of legal instruments to manage fisheries in Brazil noted a “complete disrespect for the regulations” and showed that fleets continued to land prohibited or size limited species, including the oceanic whitetip shark (Fiedler et al., 2017). This means Brazil is not only non-compliant with their own national regulations that prohibit the landing and retention of oceanic whitetip sharks, but with international management measures as well.

We also disagree that global regulations for fisheries and trade are adequate to control for the threat of overutilization via fishing pressure and the fin trade. For example, across the Pacific Ocean basin, the species has experienced and continues to experience concentrated fishing pressure and associated mortality in its core tropical distribution (Rice et al., 2015; Hall and Roman 2013). We also noted that implementation and enforcement of regulations to protect the species are likely variable across countries. Additionally, the retention-prohibition enacted by the Western and Central Pacific Fisheries Commission is not being strictly adhered to in longline fisheries (Rice et al., 2015) and will not likely decrease mortality from purse seine fisheries (Young et al., 2017). Given the depleted status of oceanic whitetip sharks across the Pacific Ocean basin, less-than-full implementation of management measures will likely undermine benefits to the species. In terms of the shark fin trade, we discussed in the status review and proposed rule several incidents of illegal oceanic whitetip fin confiscations from fishing vessels in violation of RFMO management measures. Additionally, since the listing of oceanic whitetip shark under CITES Appendix II went into effect in 2014 to control for trade, approximately 1,263 kg (2,784 lbs) of oceanic whitetip fins have been confiscated upon entry into Hong Kong because the country of origin did not include the required CITES permits. This provides evidence that some countries are not adhering to requirements under CITES and oceanic whitetip fins continue to be traded without the proper documentation certifying that the trade is not negatively affecting the species' status. Therefore, we reaffirm our conclusion in the proposed rule (see 81 FR 96320) regarding the adequacy of U.S. regulatory mechanisms in the context of the species' global range.

Comment 10: We received a similar comment from the Hawaii Longline Association (HLA) that emphasized the negligible effect of the Hawaii-based longline fisheries on the global population of the oceanic whitetip shark due to adequate regulatory mechanisms. The commenter stated that Hawaii-based longline fisheries do not engage in finning or targeting of oceanic whitetip sharks, they incidentally catch very few oceanic whitetip sharks relative to foreign fisheries, and almost all incidentally caught individuals are released alive. Specifically, the commenter pointed out that from 2005-2016, the oceanic whitetip shark only comprised 0.16 percent of all species landed in shallow-set and deep-set longline fisheries combined. Additionally, the commenter noted that in recent years, the percentage of oceanic whitetip sharks released alive is high, ranging from 91-96 percent in the shallow-set fishery, and from 78-82 percent in the deep-set fishery. They also noted that Hawaii-based longline fisheries use a variety of practices to reduce potential adverse effects on the species. Finally, the commenter warned of potential unintended conservation consequences that could result from additional regulations placed on the Hawaii-based longline fisheries as a result of a threatened listing of the oceanic whitetip shark. The commenters asserted that the extensive regulatory system that the Hawaii-based longline fisheries are managed under can create a shift in fishing effort to the very species we are trying to protect by foreign fisheries that are much less regulated (if at all).

We received comments from the Western and Central Pacific Regional Fishery Management Council (Council) along the same lines as comments from HLA, noting that the impact of the Hawaii and American Samoa longline fisheries on the oceanic whitetip shark population is likely limited relative to overall impacts occurring throughout the rest of the species' range. The Council emphasized that the combination of state and federal regulations to prohibit shark finning has likely resulted in increased amounts of oceanic whitetip sharks released alive and asserted that the stabilizing CPUE trend for the Hawaii-based PLL fishery might be attributable to the high proportion of oceanic whitetip sharks released alive over the last 15 years. Additionally, the Council noted that the Hawaii and American Samoa fisheries are operating with gear configurations recommended to reduce shark bycatch (e.g., use of circle hooks and non-use of shark lines), which further reduce the fisheries' impact on the status of the oceanic whitetip shark.

Response: We acknowledge the information provided by HLA and the Council regarding the impact of the Hawaii and American Samoa longline fisheries on the global oceanic whitetip shark population and largely agree with their comments. We explained in the proposed rule that although the Hawaii-based PLL fishery currently catches oceanic whitetip sharks as bycatch, the majority of individuals are released alive in this fishery and the number of individuals kept has shown a declining trend. In fact, the comment letter from HLA provided the same exact statistics that we discussed in the proposed rule regarding the percentage of oceanic whitetip sharks released alive in the shallow-set and deep-set fisheries (i.e., 91-96 percent and 78-82 percent, respectively). We agree that due to the extensive regulatory measures the Hawaii and American Samoa longline fisheries operate under, and the large proportion of individuals released alive, these fisheries may be less of a threat to the oceanic whitetip shark when compared to foreign industrial fisheries. However, while we agree that U.S. fisheries are not likely posing a significant threat to the species relative to foreign industrial fisheries, levels of implementation and enforcement of management measures by other fleets are likely variable across the region. As such, and as noted above in a previous comment response, given the depleted state of the oceanic whitetip population and significant level of fishing mortality the species experiences in this part of its range, less-than-full implementation across the Western and Central Pacific Ocean (WCPO) will likely undermine the benefits of any adequately implemented and enforced management measures in U.S. fisheries. Therefore, in addition to the response we gave to Comment 9 above regarding the adequacy of U.S. regulatory mechanisms in context of the species' global range, we reiterate our conclusion from the proposed rule regarding the status of oceanic whitetip sharks across the Western and Central Pacific region. Given the ongoing impacts to the species from significant fishing pressure across the WCPO as a whole, (with the majority of effort concentrated in the species' core tropical habitat area), including significant declines in CPUE, biomass, and size indices, combined with the species' relatively low-moderate productivity, we conclude that overutilization has been and continues to be an ongoing threat contributing to the extinction risk of the oceanic whitetip shark across the region (see 81 FR 96315).

With regard to unintended conservation consequences resulting from a threatened listing of the oceanic whitetip shark (i.e., a shift in fishing effort for the species by unregulated foreign industrial fisheries), we can only consider the best available scientific and commercial information regarding the biological status of the species when determining whether it meets the definition of threatened or endangered under the ESA. Therefore, we are unable to consider hypothetical ramifications of protective regulations that the commenter believes may result from listing a species. However, it should be noted that any decision to extend protective regulations to the species via a 4(d) regulation that would potentially affect U.S. fisheries will be addressed in a separate rule-making process with opportunity for public comment and input.

Comment 11: We received a comment letter from the Panama Aquatic Resources Authority within the Panama Ministry of the Environment with some new information regarding shark landings in Panama. The commenter explained that sharks are not reported at the species level in fisheries landing reports; therefore, there is no species-specific information regarding the oceanic whitetip shark in catch reports collected by the Authority. The commenter also reaffirmed information reported in the status review report and proposed rule regarding the significant decline in oceanic whitetip shark catches in the eastern Pacific purse seine fishery, which led to the Inter-American Tropical Tuna Commission's (IATTC) resolution on the conservation of the species. The comment then provided landings data for sharks in the Port of Vacamontes, and noted that sharks are caught under various types of licenses and combinations of licenses, which indicates that shark fishing in Panama is a combination of directed and incidental catch by both longliners (bottom and surface) and trawls. The commenter also included information regarding artisanal and industrial fishing fleets, noting that the oceanic whitetip shark likely has the most interaction with the longline fishery; however, there is no way to corroborate this information with the landings data from the Panama Aquatic Resources Authority. The commenter concluded that although there are no landings data for oceanic whitetip shark in Panama, this does not necessarily mean the species is not caught. Nonetheless, the commenter agreed that the available information on the species' status in the region suggests that the species warrants protection.

Response: We appreciate the information provided to us by the Panama Aquatic Resources Authority regarding shark fishing and landings data from Panamanian waters, and we have incorporated this information into our status review report for the oceanic whitetip shark. However, the information provided was very limited, and, as the commenter points out, species-specific information for oceanic whitetips in Panama is lacking. We agree with the commenter that although there is no species-specific catch or landings data, the oceanic whitetip likely interacts with the industrial longline fishery in these waters. Overall, because of the depleted status of the species in this region, any additional mortality in Panamanian waters due to bycatch in longlines supports our determination that overutilization is an ongoing threat to the species.

Comment 12: We received a report from the organization Fins Attached (Arauz 2017) stating that existing management measures and regulations in the Eastern Pacific (e.g., Resolutions passed by the IATTC and various national laws in Costa Rica) are inadequate for oceanic whitetip sharks. The report gave several examples from Costa Rica where existing regulations are failing to achieve their objectives, including a 5 percent fin-to-body weight ratio, the IATTC's Resolution C-11-10 on the Conservation of Oceanic Whitetip Sharks (which prohibits Members and Cooperating non-Members (CPCs) from retaining or landing any part or whole oceanic white tip carcass in fisheries covered by the Antigua Convention), and Costa Rica's ban on the use of fish aggregating devices (FADs).

Response: We appreciate the additional information provided in the Fins Attached report and have incorporated this information into our status review report for the oceanic whitetip shark. We agree with the commenter that existing regulatory mechanisms in the eastern Pacific are likely inadequate to halt or reverse population declines of the species in this portion of its range. As explained in the status review report and proposed rule, the IATTC's Resolution C-11-10 is not likely adequate to prevent capture and mortality in the main fishery that catches oceanic whitetip sharks in this region (i.e., the tropical tuna purse seine fishery). Therefore, because of the species' depleted status in the eastern Pacific and the ongoing fishing pressure from both purse seine and longline fisheries, we concluded that the retention prohibition for oceanic whitetip sharks in the eastern Pacific is not likely adequate in terms of effectively mitigating for the threat of overutilization in this region. The evidence provided of other inadequate regulations in this region further supports our conclusion that overutilization of oceanic whitetip shark in the Eastern Pacific is an ongoing, unabated threat contributing to the species' threatened status.

Comment 13: We received a comment letter from the Ministry of Foreign Affairs of Saint Kitts and Nevis, confirming that oceanic whitetip sharks are not targeted in the waters of St. Kitts and Nevis.

Response: We acknowledge the letter and information provided by the government of St. Kitts and Nevis. Although it is useful to know that oceanic whitetip sharks are not targeted in the waters of St. Kitts and Nevis, this information does not alter our determination regarding the species' listing status, as the main issue for the oceanic whitetip shark is incidental bycatch-related mortality and not targeted fishing.

Comment 14: We received a comment letter from an international conservation organization that expressed support for the proposed threatened listing for the oceanic whitetip shark, and concern for the species' low genetic diversity and its potential impact on the species' viability in the future. The commenter identified the African cheetah and northern elephant seal as examples of species in which severe genetic and population bottlenecks, respectively, occurred and led to low genetic variation in the seal and physiological impairments (e.g., decreased fecundity, high infant mortality and increased sensitivity to diseases) in the cheetah. The commenter urged us to continue to monitor the oceanic whitetip shark for any change in status, with particular concern for potential population or genetic bottlenecks that may result in increased inbreeding and subsequent impacts on the species' population viability in the future.

Response: We agree with the commenter that the oceanic whitetip shark has relatively low genetic diversity compared to several other circumtropical sharks. As we described in the proposed rule, the oceanic whitetip sharks' relatively low mitochondrial DNA genetic diversity raises potential concern for the future genetic health of the species, particularly in concert with steep global declines in abundance. Because only 5-7 generations of oceanic whitetip sharks have passed since the onset of industrial fishing (and hence, the intense exploitation of the species), the low genetic diversity observed in Ruck (2016) and Camargo et al. (2016) likely reflect historical levels, rather than current levels that would reflect the species' significant population declines (Ruck 2016). Thus, we agree with the commenter that genetic bottlenecks may be a cause for concern in the foreseeable future, since a species with already relatively low genetic diversity undergoing significant levels of exploitation may experience increased risk in terms of reduced fitness, evolutionary adaptability, and potential extirpations (Camargo et al., 2016). In terms of monitoring, once a species is listed under the ESA, we are required to conduct 5-year reviews to determine whether there has been any change in the species' status since the final listing rule went into effect. At that time, we can assess whether any new genetic information has become available that would indicate whether the species' extinction risk has increased due to any population or genetic bottlenecks. Additionally, any interested person can petition us to change the species' status, at which time we would evaluate any new information submitted as part of the petition.

We received numerous comments regarding actions that fall outside the scope of this rulemaking. Below are brief explanations to note the comments were received and explain why they are not considered relevant to the content of the proposed rule.

Comment 15: We received multiple comments regarding the designation of critical habitat for the oceanic whitetip shark in U.S. waters. One commenter urged NMFS to propose designated critical habitat for the oceanic whitetip shark in waters off the continental U.S., Puerto Rico, the U.S. Virgin Islands, Hawaii and the Pacific Trust Territories to the maximum extent prudent and determinable.

Response: We appreciate the submission of these comments regarding critical habitat. NMFS is required to designate critical habitat at the time of final rule publication, unless we determine that critical habitat is undeterminable at that time. We discuss our determination that critical habitat is not currently determinable for the oceanic whitetip shark in the Critical Habitat section below.

Comment 16: We received several comments related to ESA 4(d) rule making, which was discussed in the Protective Regulations Under Section 4(d) of the ESA section of the proposed rule. One commenter requested that NMFS not apply the ESA section 9 take prohibitions to licensed Hawaii-based commercial longline fishing vessels, as these prohibitions would not be necessary and advisable for the conservation of the species given that the Hawaii longline fisheries have a negligible impact on the oceanic whitetip shark relative to foreign industrialized fisheries. In contrast, another commenter requested that NMFS use its authority under ESA section 4(d) to extend the section 9(a) take prohibitions, particularly because “take” by fisheries was identified as a main threat to the oceanic whitetip shark in the status review and proposed rule, and thus take prohibitions would be necessary and advisable for the conservation of the species.

Response: The comments described above did not provide substantive information to help inform the final listing determination for the oceanic whitetip shark. For threatened species, the take prohibitions under section 9 of the ESA do not automatically apply, as they do for endangered species. Additionally, NMFS is not required to issue a 4(d) rule for threatened species in conjunction with a final ESA listing. We will do so only if we determine it is necessary and advisable for the conservation of the species. Issuance of a 4(d) rule would be done in a separate rulemaking process that would include specific opportunities for public input. As such, the comments above are noted but not responded to further in this final rule.

We did not receive, nor did we find, data or references that presented substantial new information to change our proposed listing determination. We did, however, make several revisions to the status review report (Young et al., 2017) to incorporate, as appropriate, relevant information that we received in response to our request for public comments or identified ourselves. Specifically, we updated the status review to include information regarding fisheries data and regulations from two countries that border the eastern Pacific (Costa Rica and Panama), which largely supports our determination that population declines as a result of overutilization and inadequate regulations in this region are contributing to the species' threatened status globally. We also revised the discussion of U.S. regulatory mechanisms in the status review report to include relevant time/area and seasonal closures to longline fishing gear along the East Coast of the United States. In addition, we identified a couple of new publications with relevant information regarding the life history of the oceanic whitetip shark from the Western and Central Pacific and Indian Oceans (D'Alberto et al., 2017 and Varghese et al., 2016, respectively). Specifically, these publications provide new information regarding age, growth and maturity for the species, which we incorporated into the status review report. We also identified a new paper regarding the inadequacy of fisheries regulations in Brazil (Fiedler et al., 2017), which further supports our determination that overutilization and inadequate regulations are ongoing threats to the species in the South Atlantic. Finally, we revised the discussion of the essential fish habitat (EFH) designation for the oceanic whitetip shark in U.S. waters of the Northwest Atlantic, because NMFS amended the designation in this region in 2017. We thoroughly considered the additional information we received and gathered; however, the inclusion of this new information did not alter the outcome of our risk assessment of the species.

We appointed a biologist in the Office of Protected Resources Endangered Species Conservation Division to undertake a scientific review of the life history and ecology, distribution, abundance, and threats to the oceanic whitetip shark. Next, we convened a team of biologists and shark experts (the ERA team) to conduct an extinction risk analysis for the species, using the information in the scientific review. The ERA team was comprised of a natural resource management specialist from NMFS Office of Protected Resources, a fishery management specialist from NMFS' Highly Migratory Species Management Division, and four research fishery biologists from NMFS' Southeast, Northeast, Southwest, and Pacific Island Fisheries Science Centers. The ERA team had expertise in shark biology and ecology, population dynamics, highly migratory species management, and stock assessment science. The status review report presents the ERA team's professional judgment of the extinction risk facing the oceanic whitetip shark but makes no recommendation as to the listing status of the species. The final status review report of the oceanic whitetip shark (Young et al., 2017) compiles the best available information on the status of the species as required by the ESA and assesses the current and future extinction risk for the species, focusing primarily on threats related to the five statutory factors set forth in section 4(a)(1) of the ESA. The status review report is available electronically at http://www.nmfs.noaa.gov/pr/species/fish/oceanic-whitetip-shark.html.

The status review report was subjected to independent peer review as required by the Office of Management and Budget Final Information Quality Bulletin for Peer Review (M-05-03; December 16, 2004). The status review report was peer reviewed by five independent specialists selected from the academic and scientific community, with expertise in shark biology, conservation, and management, and specific knowledge of oceanic whitetip sharks. The peer reviewers were asked to evaluate the adequacy, appropriateness, and application of data used in the status review as well as the findings made in the “Assessment of Extinction Risk” section of the report. All peer reviewer comments were addressed prior to finalizing the status review report.

We subsequently reviewed the status review report, its cited references, and peer review comments, and believe the status review report, upon which the proposed rule and this final rule are based, provides the best available scientific and commercial information on the oceanic whitetip shark. Much of the information discussed in the proposed rule and below on oceanic whitetip shark biology, distribution, abundance, threats, and extinction risk is attributable to the status review report. However, we have independently applied the statutory provisions of the ESA, including evaluation of the factors set forth in section 4(a)(1)(A)-(E), our regulations regarding listing determinations, and our DPS policy in making this final listing determination.

As stated previously and as discussed in the proposed rule (81 FR 96304; December 29, 2016), we considered whether any one or a combination of the five threat factors specified in section 4(a)(1) of the ESA is contributing to the extinction risk of the oceanic whitetip shark. Several commenters provided additional information related to threats, such as forms of overutilization, including bycatch-related fisheries mortality and the fin trade, as well as inadequate regulatory mechanisms. The information provided was consistent with or reinforced information in the status review report and proposed rule, and thus, did not change our conclusions regarding any of the section 4(a)(1) factors or their interactions. Therefore, we incorporate and affirm herein all information, discussion, and conclusions regarding the factors affecting the oceanic whitetip shark from the final status review report (Young et al., 2017) and the proposed rule (81 FR 96304; December 29, 2016).

As discussed previously, the status review evaluated the demographic risks to the oceanic whitetip shark according to four categories—abundance and trends, population growth/productivity, spatial structure/connectivity, and genetic diversity. As a concluding step, after considering all of the available information regarding demographic and other threats to the species, we rated the species' extinction risk according to a qualitative scale (high, moderate, and low risk). Although we did update our status review to incorporate the most recent life history information for the oceanic whitetip from two additional studies regarding age, growth and age of maturity, none of the comments or information we received on the proposed rule changed the outcome of our extinction risk evaluation for the species. As such, our conclusions regarding extinction risk for the oceanic whitetip shark remains the same. Therefore, we incorporate and affirm herein all information, discussion, and conclusions on the extinction risk of the oceanic whitetip shark in the final status review report (Young et al., 2017) and proposed rule (81 FR 96304; December 29, 2016).

In addition to regulatory measures (e.g., fishing and finning regulations, sanctuary designations, etc.), we considered other efforts being made to protect the oceanic whitetip shark. We considered whether such protective efforts altered the conclusions of the extinction risk analysis for the species; however, none of the information we received on the proposed rule affected our conclusions regarding conservation efforts to protect the oceanic whitetip. Therefore, we incorporate and affirm herein all information, discussion, and conclusions on the extinction risk of the oceanic whitetip shark in the final status review report (Young et al., 2017) and proposed rule (81 FR 96304; December 29, 2016).

Based on the best available scientific and commercial information, we conclude that the oceanic whitetip shark is not presently in danger of extinction but is likely to become so in the foreseeable future throughout all or a significant portion of its range. While the oceanic whitetip shark was historically one of the most abundant and ubiquitous shark species in warm tropical and sub-tropical seas around the world (Mather and Day 1954, Backus et al., 1956, Strasburg 1958), the best available scientific and commercial information suggests the species has experienced significant historical and ongoing abundance declines in all three ocean basins (i.e., globally) due to overutilization from fishing pressure and inadequate regulatory mechanisms to protect the species. Estimates of abundance decline range from 50-88 percent across the Atlantic Ocean (Northwest Atlantic, Gulf of Mexico, Southwest Atlantic; Baum and Meyers 2004, Cortés 2007, Driggers et al., 2011, Barretto et al., 2015, ICMBio 2014, Santana et al., 2004); 80-96 percent across the Pacific Ocean basin (Hall and Roman 2013, Rice and Harley 2012, Rice et al., 2015, Clark et al., 2012, Brodziak et al., 2013); and variable declines across the Indian Ocean, (IOTC 2015, Yokawa and Semba 2012, Ramos-Cartelle et al., 2012, IOTC 2011, Anderson et al., 2011). Due to the species' preferred vertical and horizontal habitat in the upper-mixed layer of warm, tropical and sub-tropical waters, the oceanic whitetip shark is extremely susceptible to incidental capture in both longline and purse seine fisheries throughout its range (Rice et al., 2015; Cortes et al., 2012, Murua et al., 2012), and thus experiences substantial levels of bycatch-related fishing mortality from these fisheries. Additionally, the oceanic whitetip shark is a preferred species in the international fin market for its large, morphologically distinct fins (CITES 2013, Vannuccini 1999), which incentivizes the retention and/or finning of the species. Although there has been some decline in the shark fin trade in recent years (Dent and Clarke 2015), we anticipate ongoing threats of fishing pressure and related mortality to continue, as the species is still regularly caught as bycatch in global fisheries and incidents of illegal finning and trafficking of oceanic whitetip fins have occurred recently despite CITES protections (Young et al., 2017, AFCD unpublished data). The oceanic whitetip shark is rendered more vulnerable to fishing pressure due its life history characteristics, including relatively slow growth, late age of maturity, and low fecundity due to its presumed biennial reproductive cycle, which limit the species' capacity to recover. Further, the species' low genetic diversity in concert with steep global abundance declines and ongoing threats of overutilization may pose a viable risk to the species in the foreseeable future. Finally, despite the increasing number of regulations for the conservation of the species, which we acknowledge may help to slow population declines to some degree, we determined that existing regulatory mechanisms are largely inadequate for addressing the most important threat of overutilization throughout a large portion of the species' range.

We conclude that the oceanic whitetip shark is not presently in danger of extinction for a number of reasons. First, the species is broadly distributed over a large geographic range and does not seem to have been extirpated in any region, even in areas where there is heavy harvest bycatch and utilization of the species' high-value fins. Given that local extirpations are often a typical precursor to range-wide extinction events, we consider this to be an indication (among others) that the species is not presently in danger of extinction. There also appears to be a potential for relative stability in population sizes 5 to10 years at the post-decline depressed state, as evidenced by the potential stabilization of two populations (e.g., NW Atlantic and Hawaii) at a diminished abundance, which suggests that this species is potentially capable of persisting at a reduced population size. Although these populations represent very small portions of the species' overall range, given that both of these populations are managed under strict fishing regulations in U.S. waters, we anticipate these stabilizing trends to continue in the near-term. We also conclude that the overall reduction of the fin trade and the marked increase in species-specific regulatory mechanisms in numerous fisheries throughout the species' range should help to reduce fisheries-related mortality and slow (but not necessarily halt) population declines to some degree, thus providing a temporal buffer in terms of the species' extinction risk. Given the foregoing reasons, we cannot conclude that the oceanic whitetip shark is presently in danger of extinction throughout all or a significant portion of its range. Therefore, based on the best available scientific and commercial information, as summarized here, in our proposed rule (81 FR 64110; September 19, 2016), and in the final status review report (Young et al., 2017), and after consideration of protective efforts, we find that the oceanic whitetip shark (Carcharhinus longimanus) is not presently in danger of extinction throughout all or a significant portion of its range, but is likely to become so in the foreseeable future (i.e., approximately 30 years). As such, we find that this species meets the definition of a threatened species under the ESA and list it as such.

Conservation measures provided for species listed as endangered or threatened under the ESA include the development and implementation of recovery plans (16 U.S.C. 1533(f)); designation of critical habitat, if prudent and determinable (16 U.S.C. 1533(a)(3)(A)); and a requirement that Federal agencies consult with NMFS under section 7 of the ESA to ensure their actions are not likely to jeopardize the species or result in adverse modification or destruction of designated critical habitat (16 U.S.C. 1536). For endangered species, protections also include prohibitions related to “take” and trade (16 U.S.C. 1538). Take is defined as to harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct (16 U.S.C. 1532(19)). These prohibitions do not apply to species listed as threatened unless protective regulations are issued under section 4(d) of the ESA (16 U.S.C. 1533(d)), leaving it to the Secretary's discretion whether, and to what extent, to extend the ESA's prohibitions to the species. Section 4(d) protective regulations may prohibit, with respect to a threatened species, some or all of the acts which section 9(a) of the ESA prohibits with respect to endangered species. Recognition of the species' imperiled status through listing may also promote conservation actions by Federal and state agencies, foreign entities, private groups, and individuals.

Section 7(a)(2) (16 U.S.C. 1536(a)(2)) of the ESA and NMFS/FWS regulations require Federal agencies to confer with us on actions likely to jeopardize the continued existence of species proposed for listing, or that result in the destruction or adverse modification of proposed critical habitat. Once a species is listed as threatened or endangered, section 7(a)(2) requires Federal agencies to ensure that any actions they fund, authorize, or carry out are not likely to jeopardize the continued existence of the species. If critical habitat is designated, section 7(a)(2) also requires Federal agencies to ensure that they do not fund, authorize, or carry out any actions that are likely to destroy or adversely modify that habitat. Our section 7 regulations require the responsible Federal agency to initiate formal consultation if a Federal action may affect a listed species or its critical habitat (50 CFR 402.14(a)). Examples of Federal actions that may affect the oceanic whitetip shark include, but are not limited to: Alternative energy projects, discharge of pollution from point sources, non-point source pollution, contaminated waste and plastic disposal, dredging, pile-driving, development of water quality standards, vessel traffic, military activities, and fisheries management practices.

Critical habitat is defined in section 3 of the ESA (16 U.S.C. 1532(5)) as: (1) The specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the ESA, on which are found those physical or biological features (a) essential to the conservation of the species and (b) that may require special management considerations or protection; and (2) specific areas outside the geographical area occupied by a species at the time it is listed if such areas are determined to be essential for the conservation of the species. “Conservation” means the use of all methods and procedures needed to bring the species to the point at which listing under the ESA is no longer necessary. Section 4(a)(3)(a) of the ESA requires that, to the extent practicable and determinable, critical habitat be designated concurrently with the listing of a species. Designation of critical habitat must be based on the best scientific data available and must take into consideration the economic, national security, and other relevant impacts of specifying any particular area as critical habitat.

In our proposal to list the oceanic whitetip shark, we requested information on the identification of specific features and areas in U.S. waters that may meet the definition of critical habitat for the oceanic whitetip shark (81 FR 96326; December 29, 2016). We have reviewed the comments provided and the best available scientific information. We conclude that critical habitat is not determinable at this time for the following reasons: (1) Sufficient information is not currently available to assess the impacts of designation; and (2) sufficient information is not currently available regarding the physical and biological features essential to conservation. We will continue to evaluate potential critical habitat for the oceanic whitetip shark, and we intend to consider critical habitat for this species in a separate action.

Because we are listing the oceanic whitetip shark as threatened, the prohibitions under section 9 of the ESA will not automatically apply to this species. As described below, ESA section 4(d) leaves it to the Secretary's discretion whether, and to what extent, to extend the section 9(a) prohibitions to threatened species, and authorizes us to issue regulations that are deemed necessary and advisable to provide for the conservation of the species.

As stated above, NMFS has flexibility under section 4(d) to tailor protective regulations based on the needs of and threats to the species. Section 4(d) protective regulations may prohibit, with respect to threatened species, some or all of the acts which section 9(a) of the ESA prohibits with respect to endangered species. We are not proposing such regulations at this time, but may consider potential protective regulations pursuant to section 4(d) for the oceanic whitetip in a future rulemaking.

In December 2004, the Office of Management and Budget (OMB) issued a Final Information Quality Bulletin for Peer Review establishing a minimum peer review standard. We solicited peer review comments on the draft status review report from five scientists with expertise on sharks in general and specific knowledge regarding the oceanic whitetip in particular. We received and reviewed comments from these scientists, and, prior to publication of the proposed rule, their comments were incorporated into the draft status review report (Young et al., 2016), which was then made available for public comment. Peer reviewer comments on the status review are available at http://www.cio.noaa.gov/services_programs/prplans/ID345.html.

A complete list of the references used is available upon request (see ADDRESSES).

We request interested persons to submit relevant information related to the identification of critical habitat and essential physical or biological features for this species, as well as economic or other relevant impacts of designation of critical habitat for the oceanic whitetip shark. Details about the types of information we are seeking can be found in the proposed rule (81 FR 96327; December 29, 2016). We solicit information from the public, other concerned governmental agencies, the scientific community, industry, or any other interested party as soon as possible but no later than April 2, 2018 (see ADDRESSES).

Section 4(b)(1)(A) of the ESA restricts the information that may be considered when assessing species for listing and sets the basis upon which listing determinations must be made. Based on the requirements in section 4(b)(1)(A) of the ESA and the opinion in Pacific Legal Foundation v. Andrus, 657 F. 2d 829 (6th Cir. 1981), we have concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA).

As noted in the Conference Report on the 1982 amendments to the ESA, economic impacts cannot be considered when assessing the status of a species. Therefore, the economic analysis requirements of the Regulatory Flexibility Act are not applicable to the listing process. In addition, this final rule is exempt from review under Executive Order 12866.

This final rule does not contain a collection-of-information requirement for the purposes of the Paperwork Reduction Act.

In accordance with E.O. 13132, we determined that this final rule does not have significant federalism effects and that a federalism assessment is not required.

For the reasons set out in the preamble, 50 CFR part 223 is amended as follows:

Need for Correction

The final 2018 specifcations for scup, summer flounder, and black sea bass published on December 22, 2017 (82 FR 60682). Following its publication, we became aware of two adjustments that need to be made that pertain to the scup and summer flounder commercial fishery quotas.

Although the 2017 scup annual catch limit (ACL) was not exceeded, landings during the summer commercial quota period exceeded the 2017 summer period quota by 46,753 lb (21,206 kg). The regulations at § 648.123(a)(2)(ii) require any landings in excess of the summer period quota be deducted, pound for pound, from the summer period quota for the following year. As a result, this action adjusts the final 2018 scup summer period quota from 9,340,986 lb (4,237 mt) to 9,294,233 lb (4,216 mt) to account for the 2017 landings overage. Because the overall 2017 ACL was not exceeded, this action does not adjust the final 2018 ACL published on December 22, 2017.

This action corrects the state quota allocated to Massachusetts by accounting for a transfer received in late December 2017. As a result of this transfer, Massachusetts received an additional 3,585 lb (1,626 kg) applied towards its 2017 quota. This results in an overage reduction from 37,816 lb (17,153 kg) to 34,231 lb (15,527 kg), which results in a revised 2018 quota of 404,742 lb (183,588 kg).

On page 60683 of the Federal Register published on December 22, 2017, Table 2 is corrected to read as follows:

Additionally, on page 60684, Table 6 is corrected to read as follows: