Federal Register Vol. 81, No.12,

Under the Animal Health Protection Act (AHPA, 7 U.S.C. 8301 et seq.), the Secretary of Agriculture may prohibit or restrict the exportation of any animal, article, or means of conveyance if the Secretary determines that the prohibition or restriction is necessary to prevent the dissemination of any pest or disease of livestock from or within the United States. The AHPA also authorizes the Secretary to prohibit: (1) The exportation of any livestock if the Secretary determines that the livestock is unfit to be moved; (2) the use of any means of conveyance or facility in connection with the exportation of any animal or article if the Secretary determines that the prohibition or restriction is necessary to prevent the dissemination of any pest or disease of livestock from or within the United States; and (3) the use of any means of conveyance in connection with the exportation of livestock if the Secretary determines that the prohibition or restriction is necessary because the means of conveyance has not been maintained in a clean and sanitary condition or does not have accommodations for the safe and proper movement and humane treatment of livestock.

The Secretary has delegated this authority to the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). Pursuant to this authority, APHIS has issued the regulations in 9 CFR part 91, “Inspection and Handling of Livestock for Exportation” (“the regulations”).

We had not substantively amended these regulations for many years and some revisions were needed. Some provisions, such as those that require pre-export inspection of livestock at an export inspection facility associated with the port of embarkation and those that set forth specific construction and maintenance standards for export inspection facilities and ocean vessels, sometimes interfered with exports. Other requirements, particularly those that required certain tests and certifications for all livestock intended for export from the United States, were not always required by importing countries or necessary for us to have assurances regarding the health and welfare of the livestock at the time of export.

For these reasons, on February 26, 2015, we published in the Federal Register (80 FR 10398-10417, Docket No. APHIS-2012-0049) a proposed rule 1 to remove requirements that we determined to be unnecessary or overly prescriptive from the regulations in order to provide exporters and APHIS with more options for inspecting and handling livestock intended for export.

Additionally, we proposed to amend the regulations so that, when an importing country is known to require an export health certificate for any animal other than livestock or for any animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes intended for export to that country, the animal or other commodity would have to have an export health certificate in order to be eligible for export from the United States.

Finally, we proposed to group certain provisions that were located in disparate sections of the regulations, and to make certain other editorial changes to make the regulations easier to read.

We solicited comments concerning our proposal for 60 days ending April 27, 2015. We received 48 comments by that date. They were from exporters, brokers, non-profit animal welfare organizations, and private citizens. We discuss the comments that we received below, grouped by topic in the following order:

• General comments on the proposed rule;

• Comments regarding specific sections of the proposed rule; and

• Comment regarding the Program Handbook.

One commenter stated that we had issued the proposed rule based on the erroneous assumption that the AHPA allows APHIS to regulate exports of livestock solely in order to protect and promote the welfare of the animals to be exported. The commenter stated that the AHPA does not delegate such authority to APHIS. In the commenter's opinion, the AHPA limits the scope of APHIS' regulation of livestock exports to those requirements that are necessary to ensure that livestock arrive in the importing country in acceptable condition and do not disseminate diseases or pests of livestock within or from the United States. Moreover, the commenter stated that, within these parameters, APHIS may only issue regulations with the intent of protecting and promoting international markets for U.S. livestock. The commenter stated that this is reflected in section 8301 of the AHPA, which provides that regulation of exports pursuant to the Act is necessary in order to “prevent and eliminate . . . burdens on foreign commerce” and to “protect the economic interests of the livestock and related industries of the United States.” The commenter concluded that the rule should be withdrawn on the grounds that APHIS had exceeded its statutory authority in issuing it.

We agree with the commenter that the primary purpose of the AHPA is to ensure that livestock that are imported into, exported from, or moved interstate within the United States do not contribute to the dissemination of pests or diseases of livestock within or from the United States. However, we disagree with the commenter's interpretation of the AHPA with regard to livestock exports.

As we noted earlier in this document, the AHPA authorizes the Secretary to prohibit the exportation of any livestock if the Secretary determines that the livestock is unfit to be moved and to prohibit the use of any means of conveyance in connection with the exportation of livestock if the Secretary determines that the prohibition or restriction is necessary because the means of conveyance has not been maintained in a clean and sanitary condition or does not have accommodations for the safe and proper movement and humane treatment of livestock. The section of the AHPA that contains these authorizations, 7 U.S.C. 8304, does not limit our authority in the manner suggested by the commenter.

Additionally, we disagree with the commenter that the Congressional findings in section 8301 of the AHPA necessarily imply such limitations. In addition to the findings cited by the commenter, Congress also finds in that section that “the health of animals is affected by the methods by which animals are transported in interstate commerce or foreign commerce.” We note, in that regard, that the AHPA does not define the term “health,” either explicitly or contextually.

The same commenter asserted that APHIS had overstated the rigidity of the previous regulations in part 91. The commenter pointed out that, at the time the proposed rule was issued, § 91.4 of the regulations provided that the Administrator may permit the exportation of livestock not otherwise permitted under the regulations, under such conditions as the Administrator may prescribe to prevent the spread of livestock diseases and to insure the humane treatment of the animals while in transit. The commenter also pointed out that paragraph (b) of § 91.14 had allowed for the use of temporarily designated ports of embarkation in conjunction with such exports. Because of these two provisions, the commenter asserted that the regulations allowed for any variances APHIS saw necessary to implement, that there was, accordingly, no need for the proposed rule, and that APHIS should therefore withdraw it.

The provisions of § 91.4 and paragraph (b) of § 91.14 were intended for specific unusual or unforeseen situations. They were not intended as a means to establish generally applicable exemptions from the regulations or alternate conditions for the exportation of livestock from the United States. Given that we considered numerous revisions to the regulations to be necessary, and given the scope of the revisions that we proposed, we consider it to have been appropriate and necessary to issue a proposed rule.

The same commenter stated that, while we had cited a recent and appreciable increase in the volume of livestock exports from the United States as part of the reason for the rule, we had provided no evidence that the previous regulations could not accommodate this increase.

The proposed rule pointed to several inefficiencies in the previous regulations that were exacerbated by the recent increase in the volume of livestock exports from the United States. For example, we pointed out that the regulations required all animals offered for exportation to undergo pre-export inspections within 24 hours of embarkation at an export inspection facility associated with the port of embarkation and additionally required most animals to be afforded 5 hours of rest at this export inspection facility. We also stated that, in our experience, it can take more than 24 hours to unload a large lot of animals into an export inspection facility for inspection. We stated that this sometimes creates a tight timeframe for unloading the animals into the facility and subsequently loading the animals for export, increased the possibility of hastened loading and unloading, and increased the likelihood that the animals could become injured or distressed because of this haste. Finally, we pointed out that some export inspection facilities associated with ports of embarkation simply lack the ability to accommodate a large lot of livestock.

Several commenters stated that we should prohibit the export of livestock, prohibit the use of shipping containers to transport livestock, set an annual limit on the number of livestock exported from the United States, prohibit the export of livestock for slaughter, or prohibit any movement of animals to slaughter. Similarly, a number of commenters suggested that we prohibit the export of horses for slaughter purposes.

Such prohibitions are outside the scope of our statutory authority.

One commenter stated that we should make an inquiry regarding the use of the livestock to be exported. The commenter pointed out that, under section 8314 of the AHPA, APHIS may “gather and compile information” that APHIS “considers to be necessary for the administration and enforcement” of the AHPA, and that such an inquiry would be consistent with this statutory authority.

We disagree with the commenter that such an inquiry is within our statutory authority. With regard to livestock exports, the section of the AHPA that the commenter cited allows APHIS to gather and collect information in order to administer the section of the AHPA that pertains to live animal exports and the inspections related to such exports. Accordingly, we can collect and gather information in order to have assurances that: (1) Animals exported from the United States will not disseminate pests of diseases of livestock within or from the United States; (2) livestock exported from the United States are fit to be moved; (3) the means of conveyance or facilities used in conjunction with the exportation of such livestock will not contribute to the dissemination of pests and diseases of livestock within or from the United States; and (4) the means of conveyance used in conjunction with the export of such livestock has been maintained in a clean and sanitary condition and has accommodations for the safe and proper movement and humane treatment of the livestock. Inquiring regarding the intended use of the livestock in the importing country does not further any of these goals and is, accordingly, outside the scope of our statutory authority.

That being said, many countries have different importation requirements for various classes of livestock. To facilitate the export of livestock to those countries, as part of our export health certification processes, we inquire regarding the intended use of the livestock in the importing country. It is important to note, however, that in such instances, this inquiry is a service that we provide at the behest of the importing country.

Several commenters asked us to modify the proposed rule to prohibit the export by sea of horses for slaughter. One commenter pointed out that, under 15 CFR 754.5, the Department of Commerce (DOC) prohibits the export by sea of horses for slaughter, and states that they will consult with USDA in order to enforce this prohibition.

While APHIS is committed to coordinating with DOC to enforce this prohibition, we do not consider it necessary to modify the proposal in such a manner. This is due to the manner in which DOC enforces 15 CFR 754.5. Under the section, exporters who wish to export horses for slaughter must obtain a short supply license from DOC. One of the conditions on the license itself prohibits the exportation by sea of horses for slaughter, and makes the licensee subject to possible revocation of his or her license, as well civil and criminal penalties, for noncompliance with this prohibition. Based on our interaction with DOC and knowledge of the slaughter horse industry, these conditions have proven to be successful, and slaughter horses are currently exported from the United States via aircraft or overland conveyance.

Several commenters asked us whether the rule pertains to animals temporarily exported from the United States for a particular event or exhibition. If it did not, they asked that provisions regarding temporary exportation of livestock and other animals be added to this final rule.

The regulations in part 91 do not pertain to the export of livestock or other animals for a temporary show or exhibition. However, requirements for the temporary export and subsequent reimportation of several species of animals are contained in 9 CFR part 93. For example, paragraph (b) of § 93.317 of the 9 CFR contains requirements for horses exported to Canada for subsequent reimportation into the United States within a period of 30 days, and paragraph (f) of § 93.101 of the 9 CFR contains requirements for U.S.-origin birds intended for reimportation into the United States following a particular theatrical performance or exhibition in Canada or Mexico.

One commenter suggested that the regulations in part 91 should state that APHIS may collaborate with other Federal agencies to implement and enforce the regulations.

Since section 8310 of the AHPA explicitly authorizes such collaboration, we do not consider it necessary to include this statement in part 91.

One commenter suggested modifying the proposed rule to require exporters to maintain contingency plans to respond to adverse events that may befall a shipment of livestock during movement from their premises of export to the port of embarkation.

We see merit in such a requirement, particularly when pre-export inspection of the livestock intended for export is conducted at a facility other than the export inspection facility associated with the port of embarkation. Accordingly, in this final rule, we require that, in order for us to authorize pre-export inspection at such facilities, among other requirements, the exporter must maintain contact information for a veterinarian licensed in the State of embarkation to perform emergency medical services, as needed, on the animals intended for export.

The same commenter also suggested modifying the proposed rule to specify that APHIS personnel must visually monitor aircraft and ocean vessels as they depart from the port of embarkation.

The commenter did not explain how such monitoring would promote or safeguard the health and safety of the livestock aboard the aircraft or ocean vessels, nor is the purpose of such monitoring readily apparent to us.

Finally, one commenter stated that APHIS had insufficient resources to implement the rule. The commenter's assertion, however, was based in large part on the stated assumption that APHIS would not abide by provisions of the rule that make certain of our services contingent on the availability of APHIS personnel. We will, however, adhere to these provisions.

In proposed § 91.1, we proposed definitions of terms that would be used in the revised regulations. We received several comments on our proposed definitions.

We proposed to define date of export as “the date animals intended for export are loaded onto an ocean vessel or aircraft, or if moved by land to Canada or Mexico, the date the animals cross the border.”

One commenter pointed out that several foreign countries define the term differently in their import requirements. In such instances, the commenter asked whether exporters should abide by the importing country's understanding of the term or APHIS'.

In such instances, exporters should abide by the importing country's understanding of the term. However, APHIS continues to collaborate with our trading partners to harmonize their definitions regarding U.S. livestock exports with our own.

We proposed to define livestock as “horses, cattle (including American bison), captive cervids, sheep, swine, and goats, regardless of intended use.”

One commenter pointed out that the AHPA defines livestock as “all farm-raised animals,” and that our proposed definition was significantly more restrictive than the AHPA's definition. The commenter asked whether our definition should be considered a statement of Agency policy regarding the animals APHIS considers to be livestock. If so, the commenter expressed concern that it could adversely impact ongoing domestic surveillance and disease control efforts in other species of animals that APHIS has traditionally considered to be livestock.

The definition of livestock that we proposed in § 91.1 pertains solely to the regulations in part 91, and is not intended as a statement of general APHIS policy. The restrictive definition of livestock reflects the classes of livestock that can feasibly be inspected at an export inspection facility associated with a port of embarkation. Moreover, these are the primary classes of livestock exported from the United States.

We proposed to replace premises of origin, used in the previous part 91, with premises of export. We stated that this was because premises of origin is often used in common speech to mean the premises where animals were born and/or raised, whereas we meant the premises where the animals are assembled for pre-export isolation (if such isolation is required by the importing country) or, if the importing country does not require pre-export isolation, the premises where the animals are assembled for pre-export inspection and/or testing, or the germplasm is collected and stored, before being moved to a port of embarkation or land border port.

One commenter stated that exporters do not construe premises of origin to mean the premises where animals are born and/or raised. For this reason, the commenter stated that we should retain the term premises of origin within the regulations.

While it may be true that, in the commenter's experience, exporters do not construe the term premises of origin to mean the premises where animals are born and/or raised, this is a misconstrual that we do encounter as an Agency from time to time.

The same commenter stated that, if we retain the term premises of origin, we should also retain the term origin health certificate, which we proposed to replace with the term export health certificate. Since we have decided not to retain premises of origin, however, we are also not retaining the term origin health certificate.

In proposed § 91.3, we proposed general requirements for the export of livestock, animals other than livestock, and animal germplasm.

Paragraph (a) of proposed § 91.3 concerned the issuance of export health certificates. In proposed paragraph (a)(1) of § 91.3, we proposed that livestock would have to have an export health certificate in order to be eligible for export from the United States.

One commenter suggested that we should instead require export health certificates for livestock when either APHIS or the exporter is aware that the importing country requires such certificates. If APHIS is not aware of such a requirement, the commenter suggested that we should authorize the export of the animals based on a good-faith effort by the exporter to determine whether the importing country requires export health certificates for the animals.

We are making no revisions in response to this comment. As we stated in the proposed rule, regardless of whether a foreign country allows livestock to be imported into their country without an export health certificate, pursuant to the AHPA, we need assurances that the livestock were fit to be moved for export from their premises of export at the time that movement occurred, and the export health certificate provides such assurances.

The commenter also asked whether this general requirement means that APHIS no longer intends to maintain IRegs, our Web site containing information regarding the animal and animal product import requirements of foreign countries.

We intend to the maintain IRegs.

In proposed paragraph (a)(2) of § 91.3, we proposed that, if an importing country is known to require an export health certificate for any animal other than livestock or for any animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes intended for export to that country, the animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes would have to have an export health certificate in order to be eligible for export from the United States. We stated that this requirement was necessary because several countries have entered into export protocols with the United States for animals other than livestock or animal germplasm in which these countries require export health certificates, and we have operationally required such export health certificates out of deference to these export protocols for many years.

One commenter stated that it was not long-standing APHIS operational policy to require such certificates.

This policy has been in effect for 9 years.

Several commenters pointed out that “known to require” is passive voice, and asked whether APHIS or the exporter would be expected to know whether an importing country required an export health certificate for animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes.

While it is the responsibility of the exporter to make a reasonable effort to determine the requirements of the importing country for particular animals and commodities, for purposes of the proposed requirement, we meant when APHIS knows the importing country to require export health certificates.

One commenter understood “known to require” in the sense that we intended it, but also understood the proposed rule to suggest that the only way by which APHIS learns of such requirements is through export protocols with foreign countries. The commenter pointed out that many foreign countries have import requirements for animals other than livestock, germplasm, and hatching eggs that were not established through export protocols negotiated with APHIS. The commenter also pointed out that export protocols for animals other than livestock, animal germplasm, and hatching eggs sometimes do not require export health certification.

We acknowledge that many export protocols do not require export health certification for animals other than livestock, germplasm, and hatching eggs. The reference to export protocols was intended to illustrate one of the means by which APHIS becomes aware of such requirements. We also learn of them through routine dialogue with foreign countries, exporters, and brokers, among other means.

Several commenters pointed out that our authority under the AHPA with regard to exports of animals other than livestock, as well as animal germplasm and hatching eggs, is limited to determining that the animals, animal germplasm, or hatching eggs will not present a risk of disseminating diseases or pests of livestock within or from the United States. In instances when the importing country requires export health certificates but has not demonstrated such a risk, the commenters questioned our authority under the AHPA to impose a Federal requirement requiring export health certificates for such animals and commodities. The commenters acknowledged that, in the absence of such certificates, the animals and commodities could not be validly exported to the country, but stated that export health certificates are more aptly characterized in such instances as a discretionary service to facilitate trade. One of these commenters construed the proposed rule to suggest that we were issuing the provisions pursuant to the World Trade Organization's Agreement on Sanitary and Phytosanitary Measures (SPS Agreement), and pointed out that the SPS Agreement is not a statute and does not provide APHIS with authority to regulate exports.

In a similar vein, one commenter stated that we should require export health certificates for animals other than livestock, animal germplasm, and hatching eggs only when we consider the animals or commodities to be potential vectors of pests and diseases of livestock. The commenter also asked whether APHIS has any efforts underway or planned in the future to encourage trading partners to relieve restrictions on the importation of animals and articles that we do not consider to be potential vectors of pests and diseases of livestock.

Several foreign countries consider any animal, germplasm, or hatching egg offered for importation to their country without an export health certificate issued by the competent veterinary authority of the exporting country to present a risk of disseminating pests or diseases of livestock within their country, and accordingly prohibit such importation.

Because of this, if we are aware that the importing country has such requirements, we consider it necessary to require export health certificates for the animals, germplasm, or hatching eggs in order to provide assurances to the importing country that, in our determination as the competent veterinary authority of the United States, we do not consider the animals, germplasm, or hatching eggs to present a risk of disseminating pests or diseases of livestock. In other words, the export health certificate functions as a requirement that we impose in order to communicate our determination that the animals or articles do not present a risk of disseminating pests or diseases of livestock from the United States. Accordingly, while we acknowledge that issuing such export health certificates is consistent with the SPS Agreement, insofar as it respects the measures that other countries impose on the importation of animals other than livestock, animal germplasm, or hatching eggs in order to protect animal health within their country, we also consider it consistent with our statutory authority under the AHPA.

We disagree that such certification should more accurately be considered a discretionary service offered by APHIS, rather than a Federal requirement. Such an approach could be construed to suggest that APHIS has evaluated all classes of animals or articles subject to such certification requirements by importing countries and determined that they present no risk of disseminating pests or diseases of livestock from the United States. We have not done so.

Finally, when we have concerns regarding the risk basis for a foreign country's import requirements, we dialogue with the country to encourage them to revise the requirements.

One commenter asked whether the proposed provisions mean that APHIS will provide export health certification for invertebrate animals, if required by an importing country. If so, the commenter asked which staff in APHIS he should contact regarding such certification.

We will do so to the extent possible. The commenter should contact the National Import Export Services staff in APHIS' Veterinary Services program.

A commenter pointed out that the paragraph would not regulate exports of animal products. The commenter stated that such products can disseminate pests and diseases of livestock, and that importing countries sometimes require export health certificates for such commodities.

The regulations in part 91 have historically pertained to live animals. The proposed rule sought to extend their scope to germplasm and hatching eggs. Such commodities are potentially viable. Animal products, however, are not viable. Thus, we are not adding provisions for the certification of such commodities to part 91.

Finally, in light of the comments received on proposed paragraph (a)(2) of § 91.3 discussed above, we are modifying its provisions from those in the proposed rule. In this final rule, it requires that, if APHIS knows that an import country requires an export health certificate endorsed by the competent veterinary authority of the United States for any animal other than livestock or for any animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes intended for export to that country, the animal or other commodity must have an endorsed export health certificate in order to be eligible for export from the United States.

Paragraph (b) of proposed § 91.3 concerned the content of export health certificates. In paragraph (b)(1) of proposed § 91.3, we proposed minimum requirements for export health certificates for livestock. In paragraph (b)(2) of proposed § 91.3, we proposed that, in addition to such minimum requirements, the export health certificate would have to meet any other information or issuance requirements specified by the importing country.

Some commenters construed these two paragraphs to mean that the requirements of the importing country would supersede our own requirements. Other commenters understood the information or issuance requirements specified by the importing country to be in addition to our minimum requirements.

The latter interpretation is correct.

Paragraph (d) of proposed § 91.3 concerned testing requirements for livestock intended for export from the United States. Among other provisions, we proposed that samples must be taken and tests made by an accredited veterinarian or APHIS representative within the timeframe allowed by the importing country. If the importing country does not specify a timeframe, we proposed that the samples would have to be taken and tests made within 30 days prior to export, except that tuberculin tests could be conducted within 90 days prior to the date of export.

One commenter pointed out that APHIS representatives, as we proposed to define them, could include individuals without doctorates of veterinary medicine. The commenter stated that the AHPA requires animal health certificates to be issued by veterinarians, and that allowing non-veterinarians to do so is outside the scope of our statutory authority.

The AHPA does not set such limits on the issuance of certificates. Additionally, as we mentioned in the proposed rule, for certain species of aquaculture, we consider employees of the United States Fish and Wildlife Service best qualified to provide such certification.

One commenter pointed out that an importing country could specify a timeframe for sampling and testing that allows the samples to be taken and tests made outside the period of time that APHIS considers the samples or tests to reliably indicate the animals' freedom from disease at the time of export. The commenter suggested that this could result in diseased animals being exported from the United States. For that reason, the commenter stated that we should instead require all samples to be taken and tests made 30 days prior to the date of export, except for tuberculin tests, which could be conducted 90 days prior to export.

We disagree with the commenter that allowing the tests to be taken outside of the period of time that we consider to reliably indicate the animals' freedom from disease at the time of export could result in diseased animals being exported from the United States. Testing is not the sole requirement for export. The livestock must also be visually inspected by an APHIS veterinarian prior to embarkation for fitness to travel. This includes inspecting the animal for signs and symptoms of infection with a disease of livestock. Any animals with signs or symptoms of such infection are subject to a full veterinary examination.

One commenter suggested that we should require follow-up tests for Program diseases, which we proposed to define as “diseases for which there are cooperative State-Federal programs and domestic regulations in subchapter C of the 9 CFR,” at the port of embarkation in order to ensure that diseased livestock are not exported from the United States.

We do not consider such testing to be necessary in order to ensure that diseased livestock are not exported from the United States; as we mentioned above, this is one of the primary purposes of pre-export inspection. Additionally, we note that many tests for Program diseases must be administered at set intervals in order to produce statistically reliable results, and that certain tests, such as the tuberculin test, can lead to anergy, i.e., erroneous results due to a lack of sensitivity to a test brought about by overtesting, if they are administered too frequently.

Finally, one commenter suggested that we should also require testing for chemical residues that would make the livestock unsuitable for human consumption.

APHIS does not have statutory authority to require such tests. We note, however, that most foreign countries have regulatory bodies that specify the maximum chemical residues that may be present in food for human consumption in that country.

In proposed § 91.4, we proposed to prohibit the export of any animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes under Federal, State, or local government quarantine or movement restrictions for animal health reasons unless the importing country issues an import permit or other written instruction allowing that animal or other commodity to enter its country and APHIS concurs with the export of the animal, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes.

One commenter asked us what the term “under quarantine” meant. The commenter pointed to various scenarios under which an exporter may voluntarily place movement restrictions on animals or commodities prior to export, such as to fulfill animal isolation requirements of the importing country.

For purposes of this section, a Federal, State, or local animal health authority must place the movement restrictions on the animal or commodity in order for it to be considered under quarantine.

The same commenter pointed out that the definition of the term “quarantine” can vary from State to State and locality to locality, and that a State or locality may impose a “quarantine” for purposes other than to prevent the dissemination of pests and diseases of livestock.

For the purposes of the section, we consider a quarantine to be the imposition of movement restrictions in order to prevent the dissemination of pests and diseases of livestock that are under official control at the Federal, State, or local level.

In proposed § 91.5, we proposed identification requirements for livestock intended for export. With one exception, we proposed to require the livestock to be identified in accordance with 9 CFR part 86. That part contains national identification standards for livestock moving in interstate commerce. We considered this requirement to be necessary in order to align our export requirements with our domestic regulations, and to facilitate the interstate movement of animals intended for export from their premises of export to an export inspection facility, port of embarkation, or land border port.

The exception that we proposed to this general requirement was for horses. We proposed to allow horses to be identified by an individual animal tattoo alone, without an accompanying description of the horse, if allowed by the importing country. We stated that this was because the United States has several long-standing export protocols with other countries that allow horses to be identified solely by individual animal tattoos.

One commenter stated that movement for export differs from movement in interstate commerce, that the movement channels are understood by States and localities to be distinct, and that such identification would not substantially facilitate the movement of livestock from their premises of export. The commenter suggested that, for export purposes, livestock only need to be uniquely identified in a manner which allows the animals intended for export to be correlated to the animals listed on the export health certificate. The commenter stated that, while identification in accordance with part 86 would allow for such correlation, it was not the only means of ensuring it.

We agree with the commenter, and have revised the section accordingly. As a result of this revision, the exception for horses is no longer necessary, and has not been finalized.

In proposed § 91.6, we proposed cleaning and disinfection requirements for means of conveyance, containers, and facilities used during movement of livestock to ports of embarkation. Among other requirements, we proposed that the means of conveyance, containers, and facilities would have to be cleaned and disinfected with a disinfectant approved by the Administrator for purposes of the section. Whereas the regulations had previously required disinfectants listed in § 71.10 of the 9 CFR to be used, we proposed to list all approved disinfectants in the Program Handbook that accompanied the proposed rule.

Several commenters expressed concern that, by moving the list of approved disinfectants to the Program Handbook, we could change the list arbitrarily and without notifying the public.

Section 91.6 sets forth the criteria we will use for amending the list of approved disinfectants. APHIS will approve a disinfectant if we determine that the disinfectant is effective against pathogens that can be spread by the animals intended for export and, if the disinfectant is a chemical disinfectant, if it is registered or exempted for the specified use by the U.S. Environmental Protection Agency (EPA) pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 135 et seq., FIFRA). We will remove a disinfectant from the list if it no longer meets these conditions for approval. We will notify the public of any changes to the list of disinfectants approved for use.

Several commenters stated that the criteria for approval of a disinfectant in § 71.10 are significantly more stringent than those that we proposed in § 91.6, and that the former should be used to ensure the safety and efficacy of all disinfectants used to disinfect means of conveyances, containers, and facilities used in conjunction with the export of livestock from the United States.

Section 71.10 contains no criteria for approving or withdrawing approval of disinfectants. The absence of such criteria in § 71.10 was, in fact, our stated purpose for proposing criteria in § 91.6.

One commenter suggested that we should ensure that chemical disinfectants used for purposes of § 91.6 do not pose a risk to the health of livestock.

When such disinfectants are registered with EPA under FIFRA, or EPA grants an FIFRA exemption for a specified use, EPA takes the risks to the environment, including to livestock, associated with the use of that disinfectant into consideration.

In proposed § 91.7, we proposed requirements regarding pre-export inspection of livestock intended for export from the United States.

The regulations had previously required livestock offered for exportation to any country other than Mexico or Canada to be inspected by an APHIS veterinarian within 24 hours of embarkation of the animals at an export inspection facility associated with the port of embarkation. In proposed paragraph (a) of § 91.7, we proposed that all livestock intended for export by air or sea would have to receive a visual health inspection from an APHIS veterinarian within 48 hours prior to embarkation. We proposed to extend the period of time within which livestock would have to receive pre-export inspection from 24 to 48 hours prior to embarkation based on the fact that we proposed to allow such inspection to take place at a facility other than the export inspection facility associated with the port of embarkation, under certain circumstances. We also did so out of recognition that, even when such inspection occurs at the export inspection facility associated with the port of embarkation, it can take more than 24 hours to load a large lot of animals safely into an ocean vessel.

One commenter pointed out that, unlike the previous regulations, the proposed regulations would not require pre-export inspection for livestock destined for overland export through Mexico.

The commenter is correct; we did not propose to retain this requirement. This is because the Secretariat of Agriculture, Livestock, Rural Development, Fisheries, and Food, the competent veterinary authority of Mexico, inspects both livestock destined for overland importation into Mexico and livestock destined for overland transit through Mexico at the U.S./Mexico border. The previous regulations were written in a manner which took into consideration the inspection afforded to livestock intended for overland importation into Mexico, but not that afforded to livestock intended for overland transit through Mexico. We additionally note that overland exports of livestock from the United States through Mexico are minimal.

Several commenters stated that extending the time period within which livestock must receive pre-export inspection from 24 to 48 hours prior to embarkation increased the likelihood that livestock unfit to travel would be exported from the United States.

The commenters provided no evidence in support of this assertion. In contrast, in our experience, animals are at an increased risk of stress or injury if they are offloaded or inspected hastily.

Several commenters stated that a visual health inspection was insufficient to detect signs or symptoms of diseases and pests of livestock, and suggested that we should require full veterinary examinations of all livestock destined for export from the United States in order to ensure that no diseased animals are exported from the United States. Similarly, one commenter asked us what a visual health inspection entails.

A visual health inspection entails careful examination of livestock for signs and symptoms that the livestock may not be fit to travel. Signs and symptoms include, but are not limited to, warts, growths, rashes, abscesses, abrasions, unhealed wounds, or unusual discharge of fluid.

APHIS veterinarians are trained to identify signs and symptoms of infection with a disease of livestock, and perform a full veterinary examination on any animal that exhibits such signs or symptoms during pre-export inspection.

We consider this protocol, coupled with the testing prescribed in § 91.3 of the regulations, to be sufficient to ensure that diseased livestock are not exported from the United States.

In proposed paragraph (a) of § 91.7, we also proposed a list of conditions that, if discovered during pre-export inspection, would make an animal unfit to travel. We proposed that the following classes of animals are unfit to travel:

• Livestock that are sick, injured, weak, disabled, or fatigued.

• Livestock that are unable to stand unaided or bear weight on each leg.

• Livestock that are blind in both eyes.

• Livestock that cannot be moved without causing additional suffering.

• Newborn livestock with an unhealed navel.

• Livestock that have given birth within the previous 48 hours and are traveling without their offspring.

• Pregnant livestock that would be in the final 10 percent of their gestation period at the planned time of unloading in the importing country.

• Livestock with unhealed wounds from recent surgical procedures, such as dehorning.

Several commenters stated that evidence of infection with a disease of livestock was not included among the proposed conditions, and suggested that the list be modified to include evidence of infectious disease as a condition that renders an animal unfit to travel.

Sick livestock, which we proposed to be unfit to travel, include livestock with evidence of infection with a disease of livestock.

One commenter asked whether a navel with a dried remnant of an umbilicus would be considered unhealed.

In some instances, such a navel could be considered healed. It will be at the discretion of the APHIS veterinarian whether to consider a particular navel healed.

The commenter also asked when APHIS considers wounds from a medical procedure to be healed.

APHIS veterinarians determine on a case-by-case basis whether a wound is healed. This determination is based on the age and general health status of the animal, the nature of the medical procedure performed, the usual recovery period associated with the procedure, and the nature of the wound.

A commenter asked how APHIS determines that animals other than livestock, animal gerplasm, or hatching eggs are fit to travel for export from the United States.

If the animals or commodities meet the conditions for importation specified by the importing country, APHIS considers them to be fit to travel.

Finally, in paragraph (a) of § 91.7, we proposed that the owner of animals or the owner's agent would have to make arrangements for any livestock found unfit to travel.

Several commenters suggested that we specify what type of arrangements the owner must make for livestock found unfit to travel. One of the commenters suggested that humane euthanasia should be listed as a type of approved arrangement, while another suggested that we should require humane euthanasia of all livestock considered unfit to travel.

If an APHIS veterinarian determines that an animal is unfit to travel for export, the owner of the animal or owner's agent must make arrangements to remove the animal from the lot of animals intended for export. Unless we consider the animal unfit to travel because we consider it a risk of disseminating a pest or disease of livestock, we do not have authority to specify the manner of arrangements which must be made.

Accordingly, while we recommend euthanasia of certain animals that we consider unfit to travel, such as animals that cannot be moved without further suffering or animals that are unable to stand unaided, we cannot require such euthanasia.

Finally, we do not recommend that all classes of animals that we consider unfit to travel be euthanized. Certain conditions that render an animal unfit to travel, such as pregnancy, are not terminal, and should not be considered as such.

In proposed paragraph (b) of § 91.7, we proposed that the APHIS veterinarian conducting pre-export inspection would either have to do so at the export inspection facility associated with the port of embarkation of the livestock; at an export isolation facility approved by APHIS, when use of such a facility is authorized by the Administrator in accordance with proposed paragraph (c) of § 91.7; or at an export inspection facility other than the export inspection facility associated with the port of embarkation, when use of such a facility is authorized by the Administrator in accordance with proposed paragraph (d) of § 91.7. We also proposed that, if the facility used to conduct the inspection is a facility other than the export inspection facility associated with the port of embarkation, it would have to be located within 28 hours driving distance under normal driving conditions from the port of embarkation, and livestock would have to be afforded at least 48 hours rest, with sufficient feed and water during that time period, prior to movement from the facility. We proposed that the facility would have to be located within 28 hours driving distance because we could not foresee any instances which would suggest authorizing inspections at an export isolation facility located more than 28 hours driving distance from the port of embarkation, and because, pursuant to the 28 hour law (49 U.S.C. 80502), the maximum amount of time that most livestock may be transported in interstate commerce without rest, feed, and water is 28 hours.

Several commenters stated that a 28 hour driving distance under normal conditions would allow pre-export inspection to be done at a significant distance from the port of embarkation. The commenters expressed concern that such travel could be stressful to the livestock and increase the risk of injury or illness befalling the animals being exported, and asked us to set a significantly lower maximum driving distance between the location at which pre-export inspection takes place and the port of embarkation. One of these commenters suggested a maximum driving distance of 60 miles or 90 minutes, whichever is further.

We agree that, under certain conditions, such travel could be stressful to the livestock. The rigors of up to 28 hours of continuous travel were, in fact, why we proposed that the livestock would need at least 48 hours of rest, with sufficient feed and water during that time period, prior to movement to the port of embarkation. It is also, in part, why we proposed conditions that would limit the use of facilities other than an export inspection facility associated with the port of embarkation to conduct pre-export inspections.

However, if livestock are properly rested, fed, and watered and if the means of conveyance transporting the livestock is equipped for such travel, with APHIS exercising monitoring and oversight, we do not consider a significant driving distance between the facility at which pre-export inspection takes place and the port of embarkation to present an intrinsic and irresolvable risk to livestock health. We have, on occasion, authorized pre-export inspection of livestock at a facility a considerable distance from the port of embarkation in order to facilitate the timely export of the animals, and have not encountered significant adverse impacts to the health or wellbeing of the livestock transported due to the distance traveled. Rather, in our experience, as well as the experience of several commenters, it is frequent loading and unloading, rather than travel itself, which puts animals at the greatest likelihood of sustaining injury or other significant adverse impacts to their health or wellbeing.

For these reasons, we do not consider it necessary to lessen the maximum allowable driving distance between the facility at which pre-export inspection is conducted and the port of embarkation from that in the proposed rule. In this regard, we note that a maximum driving distance of 60 miles or 90 minutes could impede the orderly export of certain lots of livestock and is not necessary to ensure the health and wellbeing of the livestock exported.

One commenter pointed out that the 28 hour law allows livestock to be transported more than 28 hours without rest, feed, and water, if the animals have food, water, space, and an opportunity for rest aboard the means of conveyance. The commenter stated that, if our intent was to have the regulations in § 91.7 align with the provisions of the 28 hour law, then we should provide an exemption from the maximum allowable driving distance for livestock provided such food, water, space, and opportunity for rest.

Our reference to the 28 hour law was to illustrate that a long-standing statute considers there to be potential adverse impacts to livestock health and wellbeing if the animals are moved for more than 28 hours within the United States without rest, feed, and water. Accordingly, we used the statute as one of our reference points in determining what maximum allowable driving distance to propose between the facility at which pre-export inspection is conducted and the port of embarkation. Another reference point was importer requests to date for pre-export inspection of livestock at facilities other than an export inspection facility associated with the port of embarkation. A 28 hour maximum driving distance between the facility at which the pre-export inspection is conducted and the port of embarkation would accommodate all such requests to date.

One commenter suggested that, instead of a mandatory 48 hour rest period for livestock inspected at a facility other than an export inspection facility associated with the port of embarkation prior to movement from the facility, the rest period should be tiered to the class of livestock being moved and the distance between the facility and the port of embarkation. Alternatively, the commenter asked us to explain our rationale for the 48 hour rest period.

We intended to propose a 48 hour rest period prior to the pre-export inspection of the livestock. This rest period was intended to serve in lieu of a rest period at the export inspection facility associated with the port of embarkation, so that livestock inspected at a facility other than the export inspection facility associated with the port of embarkation could be loaded directly into aircraft or ocean vessels at the port of embarkation. Since there would not be visual health inspection of the animals at the export inspection facility associated with the port of embarkation, and since the animals could travel a significant distance from the facility at which the pre-export inspection is conducted to the port of embarkation, it would be commensurately important for us to be assured that the livestock are fit for travel before they leave the facility at which the pre-export inspection is conducted. Therefore, we considered a somewhat prolonged rest period warranted.

However, we did not clarify that livestock inspected at a facility other than the export inspection facility associated with the port of embarkation would be exempt from requirements for rest, feed, and water at the export inspection facility associated with the port of embarkation.

In this final rule, we have amended both paragraph (b) of § 91.7 and § 91.8, which contains our rest, feed, and water requirements for livestock inspected at an export inspection facility associated with the port of embarkation, to clarify our intent.

As we mentioned earlier in this document, in proposed paragraphs (c) and (d) of § 91.7, we proposed conditions under which we may authorize pre-export inspection at an export isolation facility, or an export inspection facility not associated with the port of embarkation, respectively. In both paragraphs, we proposed that such authorization could occur if the exporter could show, to the satisfaction of the Administrator, that the livestock would suffer undue hardship if they had to be inspected at the export inspection facility associated with the port of embarkation.

One commenter stated that this condition was subjective.

While we agree that the condition relies on a subjective determination, the factors that we will consider in making this determination are objective. For example, we will consider the species to be inspected, the size of the lot, the likelihood of adverse climatic conditions that could affect loading the animals into and unloading the animals from the export inspection facility, and the resources that would be available at the facility the day that the livestock would be expected to arrive.

In proposed § 91.8, we proposed that all livestock intended for export by air or sea would have to be allowed a period of at least 2 hours of rest prior to being loaded onto an ocean vessel or aircraft for export. We also proposed that an inspector could extend the required rest period up to 5 hours, at his or her discretion and based on a determination that more rest is needed in order for the inspector to have assurances that the animals are fit to travel prior to loading. Finally, we proposed that adequate food and water would have to be available to the livestock during this rest period.

In the previous regulations in part 91, we had required livestock intended for export from the United States by sea or air to be allowed a period of at least 5 hours for rest at the export inspection facility associated with the port of embarkation, with adequate feed and water available, before movement to an ocean vessel or aircraft for loading for export, unless the livestock had food and water in the carrier that transported them to the export inspection facility, and they will reach the destination country within 36 hours after they were last fed and watered in the United States, or, if they are under 30 days of age, within 24 hours after they were last fed and watered in the United States.

A number of commenters stated that our proposed minimum rest period was too short. Several of these commenters suggested that we maintain a rest period of at least 5 hours. One of the commenters suggested a 3 hour minimum rest period. Another cited a peer-reviewed study that, in the commenter's opinion, suggested the need for a minimum rest period of 8 hours for livestock destined for export.2

We are making no change in response to these comments. As several commenters pointed out, movement from the premises of export to the port of embarkation may be of relatively short duration. If, for example, livestock have traveled 90 minutes to the port of embarkation, a mandatory rest period that is two to four times as long as this travel time appears excessive. For livestock that have traveled a longer distance, as we stated in the proposed rule, it is not generally our experience that they appear taxed by movement from the premises of export to the port of embarkation, and usually need time merely to become limber for the rigors of sea or air travel.

We disagree with the commenter who cited Knowles that the article suggests an 8-hour rest period is necessary for all ruminants. The article states that it pertains only to sheep destined to slaughter, and notes that, for other livestock moved for breeding or production purposes, “welfare problems rarely arise” that would suggest the need for significant rest, feed, and water. It also is worth noting that the article is from 1998, and examines conditions governing the transport of sheep to slaughter as these existed in the European Union during the 1990s. We do not consider the article applicable to current livestock export practices in the United States.

One commenter asked us whether a rest period of less than 5 hours would violate the 28 hour law.

This rest period is distinct from any rest period that must be afforded to livestock under the 28 hour law.

Finally, as we mentioned in our discussion of the comments received on proposed § 91.7, we have modified § 91.8, including its title, to clarify that it pertains only to animals inspected at an export inspection facility associated with the port of embarkation.

As modified, it states that all livestock that are intended for export by air or sea and that will be inspected for export at an export inspection facility associated with the port of embarkation must be allowed a period of at least 2 hours rest at an export inspection prior to being loaded onto an ocean vessel or aircraft for export. Adequate food and water must be available to the livestock during the rest period. An inspector may extend the required rest period up to 5 hours, at his or her discretion and based on a determination that more rest is needed in order to have assurances that the animals are fit to travel prior to loading. Pre-export inspection of the animals must take place at the conclusion of this rest period.

In proposed § 91.11, we proposed standards for APHIS approval of isolation facilities associated with the export of livestock from the United States. We stated that we considered such standards necessary because several importing countries require an “officially approved” or “APHIS-approved” period of isolation for livestock.

One commenter stated that such isolation is solely a requirement of an importing country, rather than an APHIS requirement, and that establishing standards for export isolation facilities could be construed to suggest that APHIS has identified a need for such requirements to prevent the dissemination of pests and diseases of livestock within the United States. The commenter also pointed out that the isolation required for livestock destined for export differs from importing country to importing country, and sometimes from species to species, is usually highly prescriptive, and is subject to change. For these reasons, the commenter questioned the need for standards for export isolation facilities and suggested that we not finalize the section.

We agree with the commenter that pre-export isolation is conducted solely to fulfill the requirements of an importing country, and is not required by APHIS for animal health purposes. We also agree with the commenter that the variety of export isolations required by foreign countries, as well as the prescriptive nature and mutability of those requirements, are significant impediments to establishing general standards for approval of export isolation facilities. Accordingly, we have decided not to finalize the section, as proposed.

However, we do consider it necessary to specify in the section that, if an importing country requires export isolation for livestock, such isolation must occur before the animals may be moved to a port of embarkation, and both the manner in which this isolation occurs and the facility at which it occurs must meet the requirements specified by the importing country.

As a result of this revision, § 91.11 does not contain conditions for APHIS approval of export isolation facilities. Accordingly, we have removed a reference to such approval that was in proposed § 91.7.

We have, however, retained the guidance in the Program Handbook regarding construction and operational standards for export isolation facilities. While this guidance is no longer tiered to a requirement of the regulations, it may aid exporters in fulfilling the requirements of an importing country regarding such isolation.

In proposed § 91.12, we proposed requirements regarding the ocean vessels on which livestock are exported from the United States.

In proposed paragraph (a) of § 91.12, we proposed that such vessels would need to be inspected and certified prior to initial use to transport any livestock from the United States.

We proposed that this certification would be valid for up to 3 years; however, the ocean vessel would have to be recertified prior to transporting livestock any time significant changes are made to the vessel, including to livestock transport spaces or life support systems; any time a major life support system fails; any time species of livestock not covered by the existing certification are to be transported; and any time the owner or operator of the ocean vessel changes.

Several commenters suggested that we should also require a vessel to be recertified if there is a significant mortality rate of livestock transported aboard the vessel during a particular voyage.

The purpose of the inspection and certification is to determine whether an ocean vessel is suitable for the export of livestock. High livestock mortality rates during a particular voyage do not necessarily suggest that a vessel is unsuitable for the export of livestock. For example, they could be the result of significant and unforeseen adverse weather conditions.

However, we do note that, under paragraph (f) of § 91.12, the owner or operator of an ocean vessel is required to submit a written report to APHIS within 5 business days after completing a voyage. In the report, the owner or operator must document the number of each species that died and provide an explanation for those mortalities. The owner or operator must also document whether a major life support system failed during the voyage.

If a significant number of the livestock aboard the vessel died during the voyage, and either the report indicates or APHIS has reason to believe that failure of a major life support system aboard the vessel directly contributed to the death of the livestock, the vessel will need to be recertified before it can be used again to export livestock from the United States.

In proposed paragraph (c) of § 91.12, we proposed feed and water requirements for livestock exported from the United States aboard ocean vessels. We proposed that sufficient feed and water would have to be provided to livestock aboard the ocean vessel, taking into consideration the livestock's species, body weight, the expected duration of the voyage, and the likelihood of adverse climatic conditions during transport.

One commenter stated that we did not require that livestock must be fed during the voyage. Similarly, two commenters pointed out that the previous regulations in part 91 had required ocean vessels to provide livestock with feed and water immediately after the livestock are loaded onto the vessel unless an APHIS representative determines that all of the livestock are 30 days of age or older and the vessel will arrive in the country of destination within 36 hours after the livestock were last fed and watered within the United States, or, if any of the livestock in the shipment are younger than 30 days, that the vessel will arrive in the country of destination within 24 hours after the livestock were last fed and watered within the United States.

One of the commenters acknowledged our rationale for proposing to remove this requirement from the regulations—that we have discovered that livestock can sometimes go more than 36 hours without feed or water without suffering duress—but also pointed out that we proposed to require livestock to have adequate access to feed and water during the voyage, and suggested that it is difficult to discern what adequate access to feed and water constitutes if livestock can go an indefinite amount of time aboard an ocean vessel without being fed or watered.

The other commenter pointed out that the previous regulations ensured that livestock over 30 days old would be fed at least once within a 36 hour period, and that this previous requirement was itself significantly less stringent than the 28 hour law. The commenter suggested that, in this final rule, we should specify that livestock aboard an ocean vessel must be fed and watered within 36 hours of departure from the port of embarkation.

In light of the concerns raised, we have modified paragraph (c) of § 91.12 to specify that livestock aboard the vessel must be fed and watered within 28 hours of the time they were last fed and watered within the United States. This provision is generally consistent with the 28 hour law.

A commenter stated that proposed paragraph (c) of § 91.12 does not require ocean vessels to maintain a surplus of feed in the event that the voyage takes significantly longer than expected.

In the Program Handbook that accompanied the proposed rule, we stated that, in order for us to consider feed maintained aboard an ocean vessel to be sufficient for a voyage, it would have to include a 15 percent surplus for unforeseen circumstances.

In proposed paragraph (d) of § 91.12, we proposed general requirements for the accommodations for livestock exported from the United States by ocean vessel.

In proposed paragraph (d)(1) of § 91.12, we proposed requirements for pens for livestock.

One commenter expressed concern that these proposed requirements did not require the pens to house species that are compatible with each other. The commenter pointed out that the World Organisation for Animal Health's (OIE's) standards for the transport of animals by sea recommend that animals that are likely to be hostile to other animals that are housed in the same pen should not be commingled.

We have modified paragraph (d)(1) of § 91.12 to specify that animals that may be hostile to each other may not be housed in the same pen.

In proposed paragraph (d)(2) of § 91.12, we proposed that livestock would have to be positioned during transport so that an animal handler or other responsible person could observe each animal regularly and clearly to ensure the livestock's safety and welfare.

A commenter suggested that we modify the paragraph to require the animals to be observed at least once every 12 hours.

In our experience, in order to provide routine care to livestock aboard ocean vessels, handlers observe the animals several times a day. Therefore, we do not consider it necessary to modify the paragraph to specify that the livestock must be observed at least once every 12 hours.

In proposed paragraph (d)(7) of § 91.12, we proposed that the vessel must have a system or arrangements, including a backup system in working order or alternate arrangements, for managing waste to prevent excessive buildup in livestock transport spaces during the voyage.

A commenter suggested modifying the paragraph to require the waste management system to have an alarm if the system malfunctions.

Malfunctions to waste management systems tend to be easily detectable because of the odor of the waste. Provided that the vessel maintains a backup system in working order or has alternate arrangements, we do not consider it necessary that it also maintain an alarm in the event of a system malfunction.

In proposed paragraph (d)(8) of § 91.12, we proposed that the vessel must have adequate illumination to allow clear observation of the livestock during loading, unloading, and transport.

A commenter suggested that we modify the paragraph to require the vessel to maintain a back-up lighting system.

Ocean vessels are constructed with back-up lighting systems. Therefore, we do not consider it necessary to require them.

In proposed paragraph (d)(12) of § 91.12, we proposed that the owner or operator of the ocean vessel must have on board during loading, transport, and unloading at least 3 persons (or at least 1 person if fewer than 800 head of livestock will be transported) with previous experience with ocean vessels that have handled the kind(s) of livestock to be carried, as well as a sufficient number of attendants with the appropriate experience to be able to ensure proper care of the livestock.

Several commenters suggested that we require at least one of these personnel to be a licensed veterinarian. One of these commenters asked us to delineate what we meant by “a sufficient number of attendants with the appropriate experience to be able to ensure proper care of the livestock,” and asked whether we intended one of these attendants to be a veterinarian.

We can foresee instances, such as a particularly short voyage to the importing country, when it may not be necessary for the vessel to have a veterinarian on board. However, we do agree that, for certain voyages, having a veterinarian on board may be necessary to ensure proper care of the livestock. Accordingly, in this final rule, we have modified paragraph (d)(12) of § 91.12 to specify that the APHIS representative assigned to inspect the vessel prior to loading will determine whether the personnel aboard the vessel are sufficient and possess adequate experience, including, if necessary, veterinary experience, to ensure proper care of the livestock.

A number of commenters suggested additional general requirements for ocean vessels.

Several commenters suggested that we should require ocean vessels to maintain a means of humanely euthanizing sick or injured livestock aboard the vessel, and should require at least one of the personnel aboard the ship to be trained in humanely euthanizing livestock by using the means of euthanasia carried by the vessel.

We have added such a requirement.

Several commenters suggested that we should require ocean vessels to maintain an alarm system when major life support systems aboard the vessel malfunction.

Malfunctioning major life support systems are usually easy to detect. However, we have added a requirement that the vessel must have replacement parts for major life support systems and the means, including qualified personnel, to make the repairs or replacements.

Several commenters suggested that we require ocean vessels to have a system that monitors ammonia levels aboard the vessel and alerts personnel aboard the ship if the levels exceed certain thresholds.

Excessive ammonia is easily detectable; therefore we do not consider such a requirement to be necessary.

Several commenters suggested that we require ocean vessels to maintain a system to monitor temperature, humidity, and carbon monoxide levels aboard the vessel.

Ocean vessels are constructed with such monitoring systems. Therefore, we do not consider such requirements to be necessary.

A commenter suggested that we require ocean vessels to have fire extinguishers on each level that contains livestock.

In 46 CFR 95.05-10, the United States Coast Guard requires shipping vessels to have fire extinguishers installed in all cargo compartments, unless they carry exclusively coal or grain in bulk.

Finally, one commenter suggested that ocean vessels that export livestock maintain contingency plans for emergencies. The commenter pointed out that the OIE's standards for the transport of animals by sea suggest that ocean vessels maintain such plans.

The OIE standards suggest that a “major adverse event” constitutes an emergency, but the standards do not define this term nor delineate the content of such plans. An ocean vessel may experience what we consider to be a major adverse event for any number of reasons, from adverse weather to system malfunctions to human error, and asking the vessel owner or operator to develop standard procedures for any major adverse event that could occur would place a significant paperwork burden on ocean vessel owners and operators.

Accordingly, we consider it appropriate, instead, to require ocean vessel owners or operators to document major adverse events that led to livestock deaths aboard a particular voyage. Additionally, when the major adverse event was a failure to a major life support system, the vessel will have to be inspected and recertified by APHIS before it may be used to export livestock from the United States again.

In proposed paragraph (e) of § 91.12, we proposed that an inspector could exempt an ocean vessel that uses shipping containers to transport livestock to an importing country from the requirements in proposed paragraph (d) of § 91.12, if the inspector determines that the containers themselves are designed, constructed, and managed in a manner to reasonably assure the livestock are protected from injury and remain healthy during loading, unloading, and transport to the importing country.

Several commenters understood that the intent of the rule was to acknowledge that certain of the requirements in paragraph (d) of § 91.12 are not applicable to ocean vessels that use shipping containers. However, they questioned the breadth of the exemption, and stated that certain of the requirements in paragraph (d) of § 91.12 are necessary to ensure that livestock exported from the United States remain healthy during the voyage to the importing country. Several of these commenters stated that, at a minimum, the requirements pertaining to feed and water, ventilation, and lighting, appear to be generally applicable to all ocean vessels used to export livestock.

In proposed paragraph (e) of § 91.12, we stated that guidance regarding the paragraph could be found in the Program Handbook that accompanied the proposed rule. In the Program Handbook, we provided guidance regarding the manner in which APHIS representatives would inspect ocean vessels that use shipping containers to transport livestock. We provided four areas that would be subject to particular scrutiny: The size of the containers; the materials used to construct the containers; the waste management and ventilation systems in the containers; and the manner in which potable water would be provided to the livestock.

Accordingly, it was not our intent to suggest that an inspector could exempt an ocean vessel that uses shipping containers from any of the requirements of paragraph (d) of § 91.12 that he or she so chooses. The inspector could only exempt the vessel after determining that it had in place an alternate means of meeting the aim of the requirements in paragraph (d), which is to provide reasonable assurances that livestock are protected from injury and remain healthy during loading, unloading, and transport to the importing country.

However, we do agree with the commenters that the paragraph should mention the particular areas that an inspector will evaluate as part of his or her inspection of ocean vessels that use shipping containers to transport livestock. Accordingly, we have modified paragraph (e) of § 91.12 to specify that particular attention will be paid to the manner in which the containers are constructed, the space the containers afford to livestock transported within them, the manner in which the owner or operator of the vessel would provide feed and water to the animals in the containers, and the manner in which air and effluent are managed within the containers.

As we mentioned earlier in this document, in proposed paragraph (f) of § 91.12, we proposed that the owner or operator of any ocean vessel used to export livestock (including vessels that use shipping containers) from the United States would have to submit a written report to APHIS within 5 business days after completing a voyage. Among other information requirements, we proposed that the report would have to include the number of each species that died and an explanation for those mortalities.

A commenter suggested that the report should also include the number of livestock injured during the voyage, and the nature of these injuries.

Injuries could include minor wounds or abrasions from which the livestock recovered quickly during the voyage. Conversely, animals that suffered significant or debilitating injuries during the voyage are likely to have died or been humanely euthanized. Accordingly, we do not consider it necessary to maintain a report regarding all animals injured aboard the vessel.

However, the commenter does identify a third category of animals that we did not consider in our proposed rule: Animals that sustained injuries or exhibited symptoms of illness that were significant enough to require medical attention from the personnel entrusted with care of the animals. Information regarding the number of such animals, as well as the nature of their injuries or illnesses, helps us interpret other aspects of the report accurately. Additionally, we have reason to believe that ocean vessels already maintain such information as part of their daily logs. We have modified paragraph (f) accordingly to specify that this information must be included in the report.

In proposed § 91.13, we proposed requirements regarding aircraft used to export livestock from the United States.

A number of commenters pointed out that, unlike ocean vessels, we did not propose general requirements regarding accommodations for the humane transport of livestock aboard aircraft. The commenters suggested that we should add such requirements in this final rule.

Unlike ocean vessels, an international trade association stringently regulates aircraft. The International Air Transport Association (IATA) represents more than 250 commercial airlines worldwide, including those used to export livestock from the United States. IATA's “Live Animals Regulations” set forth minimum space requirements, feed and water requirements, ambient temperature requirements, ventilation requirements, and handling requirements for aircraft that transport livestock. These requirements are at least as stringent as our requirements for ocean vessels.

Additionally, we note that, in 14 CFR part 25, the Federal Aviation Administration has its own Federal requirements for airworthiness of aircraft used to transport people, animals, or cargo.

Because of these existing regulations, we did not consider it necessary to propose our own regulations regarding accommodations for the humane transport of livestock aboard aircraft.

As we mentioned earlier in this document, we made a draft Program Handbook available along with the proposed rule. The Program Handbook provided guidance and other information regarding the proposed regulations. In instances in which the proposed regulations specified a performance or construction standard, the Program Handbook provided a means of meeting that performance or construction standard.

One commenter expressed concern that we would change the guidance in the Program Handbook arbitrarily, and without an opportunity for public participation.

It is Agency policy to take public comment on proposed substantive changes to Program standards and similar policy documents.

In paragraph (e) of § 91.3, we proposed that an original signed export health certificate would have to accompany livestock destined for export for the entire duration of movement from the premises of export to their port of embarkation or land border port, except when the export health certificate had been issued and endorsed electronically. Similarly, we also proposed that, except when an export health certificate had been issued and endorsed electronically, the original signed export health certificate would have to accompany animals other than livestock, animal semen, animal embryos, hatching eggs, other embryonated eggs, or gametes destined for export to their port of embarkation or land border port.

The intent of these provisions was to clarify that the means of issuing and endorsing an electronic export health certificate differs from the means of issuing and endorsing a paper-based export health certificate. However, we realize that the provisions could also be construed to mean that, if an export health certificate is issued and endorsed electronically, no export health certificate needs to accompany the animals or commodities destined for export or otherwise be available for review when the animals or commodities arrive at their port of embarkation or land border port.

This is not necessarily the case. Some importing countries require a paper-based export health certificate to accompany the animals or commodities destined for export, even if the export health certificate was issued and endorsed electronically. Other countries recognize electronically issued and endorsed export health certificates, but require them to accompany the animals or commodities destined for export.

Additionally, some importing countries allow the export health certificate for certain commodities to be issued and endorsed at the port of embarkation or land border port, regardless of the means of issuance and endorsement.

Accordingly, we have modified paragraph (e) of § 91.3 in this final rule. The paragraph now provides that an export health certificate for livestock must be issued and endorsed before the livestock move from the premises of export, and an export health certificate for animals other than livestock or other commodities must be issued and, if required by the importing country, endorsed by an APHIS representative prior to departure of the animals from the port of embarkation or the crossing of the land border port.

In light of this modification, we have also modified paragraph (a)(1) of § 91.3 to specify that livestock must have an endorsed export health certificate in order to be eligible for export from the United States. In the proposed rule, we did not indicate that the export health certificate needs to be endorsed.

In proposed paragraph (b) of § 91.6, we proposed that livestock for export could be unloaded only into a facility which has been cleaned and disinfected in the presence of an APHIS representative or an accredited veterinarian. We also proposed that a statement certifying to such action would have to be attached to the export health certificate by the APHIS representative or accredited veterinarian.

While this proposed requirement was also in the previous regulations in part 91, operationally we have long allowed facilities to be cleaned and disinfected without the presence of an APHIS representative or accredited veterinarian, provided that an APHIS representative or accredited veterinarian inspects the cleaned and disinfected facility, certifies that he or she has conducted this inspection, and attaches a statement certifying to this action. Whether an APHIS representative or accredited veterinarian conducts this inspection depends on the requirements of the importing country. In this final rule, we have revised paragraph (b) of § 91.6 to reflect this long-standing operational practice.

In proposed paragraph (b) of § 91.7, we proposed that, if, as a result of pre-export inspection, the APHIS veterinarian inspecting the animals deems clinical examination to be necessary to determine the animal's health, any testing or treatment related to this clinical examination would have to be conducted by an APHIS veterinarian or an accredited veterinarian.

In reviewing the proposed rule, we realized that this requirement could be construed to suggest that APHIS provides treatment as part of our clinical examinations. We do not. Rather, we coordinate with a licensed veterinarian; it is this veterinarian who provides the treatment. In this final rule, we have modified paragraph (b) of § 91.7 to make this clear.

Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.

This final rule has been reviewed under Executive Order 12866. This 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 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT.

This rule amends 9 CFR part 91, which contains requirements for the inspection and handling of livestock (cattle, horses, captive cervids, sheep, goats, and swine) to be exported from the United States. Among other things, the rule removes some prescriptive requirements applicable to livestock, either completely or by replacing them with performance standards, and makes other adjustments in inspection and handling requirements to assist exporters. These changes will provide APHIS and exporters more flexibility in arranging for the export of livestock from the United States while continuing to ensure the animals' health and welfare.

The rule also adds requirements for individual identification of livestock intended for export. The rule also specifies that, if APHIS knows that an importing country requires an export health certificate endorsed by the competent veterinary authority of the United States for any animal other than livestock, including pets, or for any hatching eggs or animal germplasm, the animal, hatching eggs, or animal germplasm must have such a health certificate to be eligible for export from the United States. These changes will help ensure that all live animals, hatching eggs, and animal germplasm exported from the United States meet the health requirements of the countries to which they are destined and that APHIS has assurances regarding their health and welfare at the time of export.

Entities directly affected by this rule include exporters of live animals, hatching eggs, and animal germplasm. While we do not know the size distribution of these exporters, we expect that the majority are small by Small Business Administration standards, given the prevalence of small entities among livestock producers. Operators of export inspection facilities, export isolation facilities within 28 hours driving distance from a port of embarkation, and ocean vessels would also be directly affected. These industries are also largely composed of small businesses. The provisions of the rule would facilitate the export process for affected parties.

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

This 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.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0432, 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 final rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

Accordingly, we are revising 9 CFR part 91 to read as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes controlled airspace at Bowman Regional Airport, Bowman, ND and removes Class E airspace at Bowman Municipal Airport, Bowman, ND.

On September 15, 2015, The FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to establish Class E airspace extending upward from 700 feet above the surface at Bowman Regional Airport, Bowman, ND (80 FR 55275) and remove Class E airspace extending upward from 700 feet above the surface at Bowman Municipal Airport, Bowman, ND (80 FR 55275, September 15, 2015). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This document amends FAA Order 7400.9Z, airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this final document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

This amendment to Title 14, Code of Federal Regulations (14 CFR) Part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6-mile radius, at Bowman Regional Airport, Bowman, ND. New standard instrument approach procedures were developed for the safety of IFR operations at the airport. Additionally, this action removes Class E airspace extending upward from 700 feet above the surface at Bowman Municipal Airport, Bowman, ND, due to closure of the airport. This action accommodates new standard instrument approach procedures at Bowman Regional Airport and enhances the safety and management of IFR operations at the airport.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (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); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA issued a Federal Finding of No Significant Impact/Record of Decision (FONSI/ROD) for the proposed relocation of the Bowman County Airport and associated actions at Bowman County, North Dakota on August 2, 2010. This action to establish Class E airspace extending upward from 700 feet above the surface at Bowman Regional Airport, Bowman, ND, and to remove Class E airspace extending upward from 700 feet above the surface at Bowman Municipal Airport, Bowman, ND, due to closure of the airport is a part of the associated actions covered in the FONSI/ROD and evaluated in the Environmental Assessment dated June 2010.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies the air traffic service route structure in the north central United States to maintain the efficient flow of air traffic.

In 1962, the FAA published in the Federal Register a rule that extended V-443 from the Cleveland, OH, VHF Omnidirection Range Tactical Air Navigation (VORTAC) navigation aid (NAVAID) over the Aylmer, Ontario, Canada, Omnidirection Range/Distance Measuring Equipment (VOR/DME) NAVAID to the Toronto, Ontario, Canada, VOR/DME NAVAID, excluding the airspace within Canada (27 FR 11497, November 22, 1962). The route extension was established in concert with the Canadian Department of Transport to provide a more direct route between Cleveland and Toronto.

In 1989, the FAA published in the Federal Register a rule to amend V-443 (54 FR 39166, September 25, 1989). The amendment inserted an intersection fix between the Aylmer, ON, Canada, VOR/DME and the Toronto, ON, Canada, VOR/DME NAVAIDs to adjust the arrival/departure routes to/from Toronto, ON, Canada, and alleviate the congestion and compression of air traffic in that area. As a result, the V-433 description was amended to reflect the route being realigned from the Aylmer, Ontario, Canada, VOR/DME, to an intersection fix defined by the Aylmer 051° and Toronto 210° radials, to the Toronto, ON, Canada, VOR/DME.

In November 2014, Canada removed the V-443 route segment from the Aylmer, ON, Canada, VOR/DME, to the Toronto, ON, Canada, VOR/DME, as part of their WTM airspace redesign program; however, corresponding action amending the FAA's V-443 legal description was not accomplished. This disconnect led to the charted depiction of V-443 being amended in the Instrument Flight Rules (IFR) low altitude enroute charts and the FAA National Airspace System Repository (NASR) database being updated, but the V-443 legal description published in FAA Order 7400.9, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR part 71, remaining unchanged.

Since the basis for establishing the V-443 route segment between the Alymer, ON, Canada, VOR/DME to the Toronto, ON, Canada, VOR/DME no longer exists, the FAA is amending the route description in FAA Order 7400.9 and 14 CFR part 71.

VOR Federal airways are published in paragraph 2010 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airway listed in this document will be subsequently amended in the Order.

This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.9Z lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending Title 14 of the Code of Federal Regulations (14 CFR) part 71 by removing the route segment of V-443 that extends from Aylmer, ON, Canada, to Toronto, ON, Canada. The remaining portion of V-443 is unchanged. This action responds to the route changes made by Canada as part of their WTM airspace redesign project. Canada has subsequently removed this route segment and it no longer exists on aeronautical charts. Therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.

All radials in the route description below are unchanged and stated in True degrees.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a. This airspace action consists of modifying an airway and it is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exists that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

I. Table of Abbreviations BNM Broadcast Notice to Mariners CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security E.O. Executive order FR Federal Register ILR Illinois River NPRM Notice of proposed rulemaking Pub. L. Public Law § Section UMR Upper Mississippi River U.S.C. United States Code II. Background Information and Regulatory History

The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because of the increased safety risks caused by high waters on the UMR and ILR. On December 28, 2015, the Coast Guard determined that immediate action is necessary to establish emergency safety zones to protect life and property from the hazards associated with and resulting from high waters. It is impracticable to publish an NPRM because we must establish these safety zones by December 28, 2015. Broadcast Notices to Mariners (BNM) and information sharing with waterway users will update mariners of the closures and enforcement times during this emergency situation.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. Providing 30 days notice would be contrary to public interest because immediate action is needed to protect life and property from the hazards associated with and resulting from high waters.

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Upper Mississippi River determined that potential hazards associated with and resulting from high waters and related recovery efforts are present in the area. These hazards require additional safety measures in the form of safety zones extending from mile 109.9 to 185.5 on the UMR and mile 0 to 128.9 on the ILR to protect those operating in the area and for the Coast Guard to maintain navigational safety.

The Coast Guard is establishing two temporary emergency safety zones prohibiting access to the UMR between miles 109.9 and 185.5 and the ILR between miles 0 and 128.9, extending the entire widths of the rivers beginning at 3:00 p.m. on December 28, 2015, through 11:59 p.m. on January 22, 2016 or until waters recede and conditions allow for safe navigation, whichever occurs earlier. Deviation from the emergency safety zones may be requested and will be considered on a case-by-case basis as specifically authorized by the COTP or a designated representative. Deviation requests will be considered and reviewed on a case-by-case basis. The COTP may be contacted by telephone at 314-269-2332 or can be reached by VHF-FM channel 16.

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

E.O.s 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget. This rule establishes temporary emergency safety zones placing restrictions on vessels transiting the UMR between miles 109.9 and 185.5 and the ILR between miles 0 and 128.9. Notifications of enforcement times will be communicated to the marine community via BNM. The impacts on navigation will be limited to ensure the safety of mariners and vessels during hazardous conditions associated with high waters.

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a closure of the UMR between miles 109.9 and 185.5 and the ILR between miles 0 and 128.9. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. A preliminary environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

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

Section 172(c)(1) of the CAA provides that SIPs for nonattainment areas must include reasonably available control measures (RACM), including RACT, for sources of emissions. Section 182(b)(2)(A) provides that for certain nonattainment areas, states must revise their SIP to include RACT for sources of VOC emissions covered by a CTG document issued after November 15, 1990 and prior to the area's date of attainment. In 2008, EPA developed new CTGs for miscellaneous metal and plastic parts coatings, automobile and light-duty assembly coatings, miscellaneous industrial adhesives, and fiberglass boat manufacturing materials.

On November 15, 2013, the Pennsylvania Department of Environmental Protection (PADEP) submitted to EPA on behalf of ACHD a SIP revision concerning the adoption of the EPA CTGs for miscellaneous metal and/or plastic parts surface coating processes, automobile and light-duty truck assembly coatings, miscellaneous industrial adhesives, and fiberglass boat manufacturing materials in Allegheny County. These ACHD regulations, with a state effective date of June 8, 2013, are contained in the ACHD Rules and Regulations, Article XXI, Air Pollution Control sections 2105.83 (Control of VOC Emissions from Miscellaneous Metal and/or Plastic Parts Surface Coating Processes), 2105.84 (Control of VOC Emissions from Automobile and Light-Duty Truck Assembly Coatings), 2105.85 (Control of VOC Emissions from Miscellaneous Industrial Adhesives), and 2105.86 (Control of VOC Emissions from Fiberglass Boat Manufacturing Materials) in order to establish: (1) Applicability for miscellaneous metal and/or plastic parts surface coating processes, automobile and light-duty truck assembly coatings, miscellaneous industrial adhesives, and fiberglass boat manufacturing materials; (2) exemptions; (3) record-keeping and work practice requirements; and (4) emission limitations. Upon review of the November 15, 2013 submittal, EPA found that the table of average monomer VOC content limits for fiberglass boat manufacturing materials was referenced; however, the table was erroneously not included in the regulation. Pursuant to section 110(k)(4) of the CAA, PADEP submitted on behalf of ACHD a letter dated July 16, 2014 committing to submit a SIP revision to EPA addressing this error.

On March 26, 2013 (78 FR 18241), EPA conditionally approved the SIP revision concerning the adoption of these CTGs. On September 9, 2015, PADEP submitted to EPA on behalf of ACHD a supplemental SIP revision containing the regulation with the missing table of average monomer VOC content limits, and thereby addressed its July 16, 2014 commitment. On November 10, 2015, EPA published a notice of proposed rulemaking converting the conditional approval to a full approval. 80 FR 69627. Other specific requirements and the rationale for EPA's proposed rulemaking action are explained in the NPR and will not be restated here. No public comments were received on the NPR.

In this rulemaking action, EPA is converting to a full approval the conditional approval of the Commonwealth of Pennsylvania SIP revision submitted on November 15, 2013, as supplemented with the September 9, 2015 SIP submittal, which consists of amendments to the ACHD Rules and Regulations, Article XXI, Air Pollution Control for adopting RACT for sources covered by EPA's CTG standards for the following categories; miscellaneous metal and/or plastic parts surface coating processes, automobile and light-duty truck assembly coatings, miscellaneous industrial adhesives, and fiberglass boat manufacturing materials. Pursuant to section 110(k)(4) of the CAA, the conditional approval was based upon a letter from PADEP on behalf of ACHD dated July 16, 2014 committing to submit to EPA an additional SIP revision to address the deficiency in the regulation for fiberglass boat manufacturing materials. On September 9, 2015, PADEP on behalf of ACHD, submitted a supplemental SIP revision containing the table of monomer VOC content limits for fiberglass boat manufacturing materials. EPA has determined that ACHD has satisfied this condition. Therefore, EPA is removing the conditional nature of its approval and replacing it with a full approval of Allegheny County's adoption of CTGs for miscellaneous metal and/or plastic parts surface coating processes, automobile and light-duty truck assembly coatings, miscellaneous industrial adhesives, and fiberglass boat manufacturing materials.

In this rulemaking, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference the ACHD regulations regarding control of VOC emissions discussed in section II of this preamble. EPA has made, and will continue to make, these documents generally available through www.regulations.gov and/or may be viewed at the EPA Region III office (see the ADDRESSES section of this preamble for more information).

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by March 21, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action pertaining to ACHD's adoption of CTG standards for miscellaneous metal and/or plastic parts surface coating processes, automobile and light-duty truck assembly coatings, miscellaneous industrial adhesives, and fiberglass boat manufacturing materials may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 52 is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0457 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before March 21, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0457, by one of the following methods:

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

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

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

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www2.epa.gov/dockets.

In the Federal Register of October 24, 2014 (79 FR 63594) (FRL-9916-03), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition ((PP) 4F8251) by J.R. Simplot Company, 5369 W. Irving St., Boise, ID 83706. Also, in the Federal Register of December 17, 2014 (79 FR 75107) (FRL-9918-90), EPA inadvertently re-announced the filing of this same petition. The petition requested that 40 CFR part 174 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Potato Late Blight Resistance protein VNT1 in or on potato. Those documents referenced a summary of the petition prepared by the petitioner J.R. Simplot Company, which is available in the docket EPA-HQ-OPP-2014-0457, http://www.regulations.gov. Upon determining that such exemption meets the FFDCA safety standard, EPA established a temporary exemption from the requirement of a tolerance for residues of Potato Late Blight Resistance protein VNT1 in or on potato when used in accordance with the terms of EUP 8917-EUP-2, with an expiration date of December 31, 2015, in the Federal Register of February 23, 2015 (80 FR 9387) (FRL-9922-53).

In the Federal Register of September 9, 2015 (80 FR 54257) (FRL-9933-26) EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition ((PP) 5G8375) by J.R. Simplot Company, 5369 W. Irving St., Boise, ID 83706. The petition requested that 40 CFR 174.534 be amended. That document referenced a summary of the petition prepared by the petitioner J.R. Simplot Company, which is available in the docket EPA-HQ-OPP-2014-0457, http://www.regulations.gov. No comments were received on this FR notice.

Because the pesticide petition ((PP) 5G8375) was submitted concurrently with a request to amend the EUP linked to this tolerance exemption, EPA only considered amendments to the tolerance exemption relevant to the pending request to extend the associated EUP. The request to amend the EUP involved increased acreage, locations and extending the expiration date of EUP No. 8917-EUP-2 to April 1, 2017. Because EPA is extending the EUP until April 1, 2017, EPA is revising the expiration date of the existing tolerance exemption to April 1, 2017.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe ” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

The Agency previously assessed the toxicological profile of the VNT1 protein and the likely exposure from its use as a plant-incorporated protectant in or on potato in accordance with the terms of EUP No. 8917-EUP-2. Based on the Agency's assessment, the Agency concluded that there is a reasonable certainty that no harm will result from aggregate exposure to VNT1 protein when used as a plant-incorporated protectant in or on potato in accordance with the terms of EUP No. 8917-EUP-2. See (80 FR 9387) (February 23, 2015). Because the toxicological profile has not changed, any additional exposure to the VNT1 protein as a result of the extension of the associated EUP will not affect the Agency's previous safety finding. Therefore, the Agency is relying on its previous assessment to support the extension of the expiration date for 40 CFR 174.534. Therefore, based on its previous assessment, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues of VNT1 protein in potato when it is used as a plant-incorporated protectant. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information.

The Agency has determined that an analytical method is not required for enforcement purposes since the Agency is establishing a temporary exemption from the requirement of a tolerance without any numerical limitation in association with use under EUP No. 8917-EUP-2.

The Agency is extending the expiration date of this temporary tolerance exemption to April 1, 2017. The temporary tolerance exemption will expire on the same date as the concurrent EUP for VNT1 protein (8917-EUP-2).

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

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

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

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

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

Therefore, 40 CFR chapter I is amended as follows:

HHS is correcting its regulations in line with FR Doc. 2014-28697, published on December 19, 2014 (79 FR 75871), entitled “Federal Awarding Agency Regulatory Implementation of Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards”, the “Guidance for Reporting and Use of Information Concerning Recipient Integrity and Performance” to 2 CFR part 200, published on July 22, 2015 (80 FR 43301), and “Universal Identifier and System of Award Management; Corrections”, published on September 10, 2015 (80 FR 54407), made by the Office of Management and Budget (OMB). HHS adopts the correcting amendments made by OMB. HHS is also making amendments to address citation or grammatical inconsistencies, to amend incomplete statements in the regulation, and to update existing HHS regulations to incorporate 45 CFR part 75. The correcting amendments will go into effect at the time of publicatio

Under the authority of (5 U.S.C. 301), the Department of Health and Human Services amends 42 CFR parts 38, 50, 51, 51a, 51b, 51c, 51d, 52, 52a, 52b, 52c, 52d, 52e, 55a, 56, 57, 59, 59a, 62, 63a, 64, 65, 65a, 66, 67, 124, 136, 403, 417, 430, 433, 434, 435, 436, 438, 440, 441, 456, 457, and 1001, and 45 CFR parts 16, 63, 75, 87, 95, 98, 261, 262, 263, 265, 286, 287, 301, 302, 303, 304, 309, 400, 1000, 1301, 1304, 1309, 1321, 1326, 1328, 1336, 1355, and 1357 by making the following correcting amendments:

Background

On July 15, 2013, we received a petition from WildEarth Guardians to list 81 marine species as threatened or endangered under the Endangered Species Act (ESA). We found that the petitioned actions may be warranted for 27 of the 81 species and announced the initiation of status reviews for each of the 27 species (78 FR 63941, October 25, 2013; 78 FR 66675, November 6, 2013; 78 FR 69376, November 19, 2013; 79 FR 9880, February 21, 2014; and 79 FR 10104, February 24, 2014). On December 16, 2014, we published a proposed rule to list the dusky sea snake (Aipysurus fuscus) and three foreign corals (Cantharellus noumeae, Siderastrea glynni, and Tubastraea floreana) as endangered species, and we proposed to list the Banggai cardinalfish (Pterapogon kauderni) and Harrisson's dogfish (Centrophorus harrissoni) as threatened species (79 FR74953). We requested public comment on information in the status reviews and proposed rule through February 17, 2015. This final rule provides a discussion of the information we received during the public comment period and our final determination on the petition to list the Banggai cardinalfish (Pterapogon kauderni) and Harrisson's dogfish (Centrophorus harrissoni) under the ESA. Our final determinations for the other species proposed for listing in the December 16, 2014, proposed rule (dusky sea snake and three foreign corals) were made in a prior rule (80 FR 60560). The status of the findings and relevant Federal Register notices for those and the other 21 species can be found on our Web site at http://www.nmfs.noaa.gov/pr/species/petition81.htm.

We are responsible for determining whether species are threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). To make this determination, we consider first 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.”

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 and an 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, 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 making a listing determination, we first determine whether a petitioned species meets the ESA definition of a “species.” Next, using the best available information gathered during the status review for the species, we complete a status and extinction risk assessment. In assessing extinction risk for these two species, we consider the demographic viability factors developed by McElhany et al. (2000) and the risk matrix approach developed by Wainwright and Kope (1999) to organize and summarize extinction risk considerations. The approach of considering demographic risk factors to help frame the consideration of extinction risk has been used in many of our status reviews, including for Pacific salmonids, Pacific hake, walleye pollock, Pacific cod, Puget Sound rockfishes, Pacific herring, scalloped hammerhead sharks, and black abalone (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, growth rate/productivity, spatial structure/connectivity, and diversity. These viability factors reflect concepts that are well-founded in conservation biology and that individually and collectively provide strong indicators of extinction risk.

We then assess efforts being made to protect the species, to determine if these conservation efforts are adequate to mitigate the existing threats. 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 to protect the species.

In the solicitation for information from the public on the proposed rule, we received information and/or comments on the Banggai cardinalfish and Harrisson's dogfish proposals from 13 parties. These comments are broken out by species and summarized below.

Twelve commenters submitted information and/or commented on the proposed listing of the Banggai cardinalfish.

Comment 1: One commenter felt that instead of listing under the ESA, the Banggai cardinalfish would derive a greater benefit if we would engage in direct talks and support for Indonesia's internal efforts to conserve the species. The commenter also felt that continued efforts to list the species under the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) should be undertaken.

Response: We were petitioned to list the Banggai cardinalfish and found that the petitioned action may be warranted for the species (see Background). Thus, we are required to review the best available scientific and commercial data to determine whether the species is threatened or endangered under the ESA (16 U.S.C. 1531 et seq.). We agree that Indonesia's efforts to conserve and protect the Banggai cardinalfish are essential to the long-term viability of the species and should be supported. The ESA recognizes the international instruments, including CITES, to conserve and protect various species. Further, the ESA calls for a suite of engagements to enhance international cooperation with foreign nations where listed species occur. Through the ESA, we are encouraged to work with foreign countries to enter into bilateral or multilateral agreements to provide for conservation of species. Regarding CITES, in 2007, due to overharvest concerns, the Banggai cardinalfish was proposed to be listed under CITES Appendix II. Appendix II includes species that are vulnerable to overexploitation, but not at risk of extinction under CITES criteria; trade must be regulated to avoid exploitation rates that are incompatible with species survival. Indonesia did not support the proposal and it was withdrawn. The next Conference of the Parties (COP) will be held in 2016. The United States has not determined which species it will propose for listing at the next COP. The United States has a public process to determine which species it will propose.

Comment 2: One commenter stated that requiring the aquarium trade to only buy captive-bred or maricultured specimens through a section 4(d) protective regulation would not control commercial trade in wild-caught fish because there is no way to discern a captive-bred or maricultured specimen from a wild-harvested one.

Response: We agree that identifying a captive-bred from a wild-harvested fish would be difficult. We have not decided which, if any, of the section 9 prohibitions to apply to the Banggai cardinalfish. We intend to announce an advance notice of proposed rulemaking to solicit public comment and information on any section 4(d) protective regulation, if proposed, for the Banggai cardinalfish.

Comment 3: Many commenters felt that the data do not support a listing under the ESA. Rather, they stated that the Banggai cardinalfish should be listed as a species of concern. They recommended continued data collection on population trends and structure, stratified by habitat in both the historical and introduced ranges, establishment of a sampling regime to quantify habitat trends in abundance and quality, studies of the Banggai cardinalfish's use of alternative microhabitats, and consultations with the Republic of Indonesia on current and future management plans for wild harvest and captive propagation. One commenter felt the population abundance transect surveys need to be standardized, given the species' patchy distribution and variable density. They felt this was necessary for future evaluations on the species' population status and trends. However, they agreed with the overall conclusion that abundance has declined due to unsustainable harvest in the early years. One commenter recommended we extend the period to make a final determination, citing a lack of data to support the proposed listing and the need to solicit additional data.

Response: We disagree that the data are insufficient to make a listing determination. Data exist on the Banggai cardinalfish's biology, population structure, abundance, trends, habitat use and threats that were reported in the proposed rule and the status review. We agree that standardized surveys across years would be ideal. However, the existing data indicate an overall population decline, and decreases in population density are also evidenced by significant declines in the catch per unit effort. Prior to 2003, collectors from Bone Baru typically required one day to capture approximately 2,000 specimens. In 2007, they reported requiring one week to capture the same number. For Banggai Island, reported mean catch declined from about 1,000 fish/hour in 2000 to 25-330 fish/hour in 2004. Extirpations of populations within the Banggai cardinalfish's natural range have occurred. In particular, extirpation of local populations has been documented in areas with increased harvest of microhabitat, such as Diadema sea urchins and sea anemones, combined with fishing pressure on Banggai cardinalfish. Further fragmentation of an already small endemic population, which exhibits high genetic population substructuring, increases the extinction risk for the Banggai cardinalfish.

Comment 4: One commenter felt that the species' life history represents an adaptation of a small-bodied fish to its physical environment (i.e., shallow waters separated by deep channels with swift currents). They contend that its early maturity, low fecundity, and extended parental care are manifestations of a reproductive strategy in a physically limited environment. They state that situational cannibalism is further evidence of a behavior adapted to maintain abundance within the carrying capacity of its microhabitat-oriented habitat. Therefore, they do not concur with the assertion that these characteristics lower Banggai cardinalfish resilience.

Response: While we agree the Banggai cardinalfish life history characteristics are likely adaptive, we disagree that these traits do not render the species less resilient and vulnerable to threats. The Banggai cardinalfish lacks dispersal ability and exhibits high site fidelity, and new recruits stay within parental habitat. Thus, population discreteness is high and recolonization is unlikely once a local population is extirpated. Local populations off Liang Island, Peleng Island, and Masoni Island are reported extirpated, and interviews with local fishermen indicate extirpation of local populations throughout the Banggai Archipelago.

Comment 5: Several commenters provided information on their shift from purchasing wild-harvest to mariculture specimens, including from domestic facilities. Many commenters felt that directed harvest for the live marine ornamental reef fish trade no longer poses a significant threat to the Banggai cardinalfish.

Response: We appreciate the information submitted, as it supports the proposed rule's statement that Banggai cardinalfish exports for the ornamental live reef fish trade may be decreasing, although systematic data are lacking. We reported that the large-scale aquaculture facility based in Thailand and efforts to captive-breed the species in the United States may alleviate some of the pressure to collect fish from wild populations, but the degree to which aquaculture would affect harvest of wild populations is unknown. As we explain in more detail in the response to the next comment, the evidence shows that directed harvest for the live marine ornamental reef fish trade and harvest of microhabitat remain concerns.

Comment 6: One commenter felt that the improved harvest practices, development of significant aquaculture production, and Indonesian management initiatives undertaken since 2007 were not fully considered in the proposed rule.

Response: We disagree. All section 4(a)(1) factors that are found to pose an extinction risk to the Banggai cardinalfish, as well as ongoing conservation efforts and other mitigating factors, were considered in the proposed rule. In the proposed rule, we considered the improved harvest practices, the increasing aquaculture facilities, and the local management initiatives under these factors. If the species is endangered or threatened with extinction because of any one of the 4(a)(1) factors, then we must determine that listing is warranted. In our synthesis of the extinction risk to the Banggai cardinalfish, we stated that overutilization from direct harvest for the ornamental live reef fish trade has significantly impacted the Banggai cardinalfish and remains a concern. We further stated an increase in compliance with the Fish Quarantine regulations and improved trade practices have occurred in recent years, and we anticipated compliance and trade practices will likely continue to improve in the future, which may mitigate impacts through sustainable trade. However, since the proposed rule, interviews were held in March 2015 with Indonesian government officials and Banggai cardinalfish collectors. The interviews were conducted by Dr. Vagelli, New Jersey Academy for Aquatic Sciences, who served as a peer reviewer (Information Quality Act, Pub. L. 106-554) for the Banggai cardinalfish status review. The March 2015 report (Vagelli unpublished report 2015) is available upon request (see FOR FURTHER INFORMATION CONTACT). Indonesian officials and collectors reported that compliance with the Fish Quarantine regulations was largely voluntary and that improved trade practices had not been implemented (Vagelli unpublished report 2015). Thus, reports are conflicting on whether compliance and trade practices have improved and are likely to improve in the future. Participation in collection of Banggai cardinalfish for the live ornamental reef trade has dropped in recent years. Captive-bred facilities have recently started in the United States and Thailand and are anticipated to decrease the threat of directed harvest of the wild populations in the future, but the degree to which aquaculture would affect harvest of wild populations is unknown. Data also indicate that by 2007, harvest of microhabitat (sea urchins and sea anemones) had negatively impacted cardinalfish populations, and the harvest had increased by 2011, and will continue in the future, which negatively impacts Banggai cardinalfish and their ability to avoid predators. Overutilization from direct harvest for the ornamental live reef fish trade has significantly impacted the Banggai cardinalfish and remains a concern. Data from several sources reported an increase in compliance with the Fish Quarantine regulations and improved trade practices, but an updated survey in 2015 reported voluntary compliance and a lack of improved trade practices. For these reasons, we conclude that directed harvest for the live marine ornamental reef fish trade harvest and harvest of microhabitat remain concerns.

Comment 7: One commenter stated that the introduced populations in Palu Bay and Luwuk Harbor must be considered in the listing process.

Response: We considered these introduced populations. The introduced populations are an artifact of the commercial ornamental live reef trade and are not part of any conservation program to benefit the native populations. The introduced populations were introduced through the practice of high-grading (i.e., discarding live specimens determined to be of low quality/non saleable) or escapement near trade centers for the ornamental live reef market. The introduced population at Lembeh Strait is considered invasive and may be impacting local diversity through interspecific competition for resources in the area, but specific data on ecological impacts are lacking. Because one of the purposes of the ESA is to provide a means whereby the ecosystems upon which endangered and threatened species depend may be conserved (16 U.S.C. 1531(b)), we consider a species' natural range to be biologically and ecologically important to the species' viability to persist in the face of threats. The introduced populations are outside of the Banggai cardinalfish's natural range and may not contribute to the species' ability to persist and therefore were not included in the analysis of the overall extinction risk to the species.

Comment 8: One commenter disagreed with the statement in the proposed rule that designation of critical habitat was not proposed for any of the species, including the Banggai cardinalfish, because critical habitat shall not be designated in foreign countries or other areas outside U.S. jurisdiction (50 CFR 424.12(h)). The commenter argued that we should construe areas under U.S. “jurisdiction,” as used in § 424.12(h), to include Taiwan and areas under U.S. military protection. The commenter cited multiple sections in U.S. Code Title 22, Foreign Relations and Intercourse, and referenced “U.S. Navy Okinawan Dugong litigation” without citation.

Response: We found one line of cases involving the Department of Defense and the Okinawa dugong (Ctr. for Biological Diversity v. Hagel, 80 F. Supp. 3d 991 (N.D. Cal. 2015); Okinawa Dugong v. Gates, 543 F.Supp.2d 1082 (N.D. Cal. 2008); Okinawa Dugong v. Rumsfeld, No. 03-4350, 2005 WL 522106 (N.D. Cal. Mar. 2, 2005) (unpublished)). These cases interpret specific provisions of the National Historic Preservation Act, not the ESA, and have no bearing on interpretation or application of 50 CFR 424.12(h). We also note that the Banggai cardinalfish's natural historical and present range does not occur within the area mentioned by the commenter, and therefore, the question of critical habitat designation is irrelevant.

We received a single submission on the proposal to list Harrisson's dogfish from the Australian Government Department of the Environment. We briefly summarize their comments below and respond with references to our prior documents where relevant.

Comment 9: The proposal to list Harrisson's dogfish suggests that lower catches in recent years reflect a decreasing population. This conclusion appears not to have taken into account restrictive catch limits for Harrisson's dogfish in the last five years in the Southern and Eastern Scalefish and Shark Fishery (SESSF). Since 2010, a limit of 15 kg per day of Harrisson's dogfish has been implemented, which has contributed to reductions in catch rates by stopping targeted fishing and encouraging active avoidance of dogfish.

Response: The text in the proposed rule, to which this comment refers, states “However, even before the prohibition, reported catch rates of Harrisson's dogfish in the SESSF have been minimal in recent years, likely due to the low abundance of the species on the continental margin where the fisheries operate.” While we agree that the 2010 catch limit does, in part, contribute to the observed low catches of the species, we would like to point out that even before the 2010 catch limit, C. harrissoni catches were rare. According to Walker et al. (2009), annual catches of Harrisson's dogfish in the SESSF from 2000-2006 were <1 t. Catches of all gulper sharks (C. harrissoni, C. moluccensis, C. zeehaani) have also been decreasing since the mid-1990s (Georgeson et al. 2014). Given that Harrisson's dogfish's relative abundance on the upper-slope is estimated to have declined by over 99 percent between 1976-77 and 1996-97 (Graham et al. 2001), we find that the minimal catches of the species, even prior to 2010, are more likely a reflection of the low abundance and rarity of the species on the continental margin.

Comment 10: The proposal to list Harrisson's dogfish notes that there is potentially high at-vessel mortality of Harrisson's dogfish in auto-longline (ALL) gear and cites to Williams et al. (2013a). However, the proposal does not appear to have considered tagging studies, which indicate post-capture survival rates on ALL gear to be between 65 and 95 percent, potentially downgrading capture on longline to a lower risk method (Williams et al. 2013a).

Response: The Status Review Report (Miller 2014), upon which the proposed rule for Harrisson's dogfish was based, discusses the potential for high at-vessel mortality in ALL gear. Citing the Williams et al. (2013a) paper, Miller (2014) notes that mortality of Harrisson's dogfish after capture on ALL gear ranged from 4 percent (if estimates included only confirmed dead sharks immediately after capture) to as high as 73 percent (if estimates included sharks that swam away slowly after capture, indicating stress or shock, as potential mortalities). The comment above appears to refer to the estimates of post capture survival on ALL gear from tagging studies on a different gulper species, the Southern dogfish (C. zeehaani), as reported in Williams et al. (2013a) which further cited Williams et al. (2012). Based on detections from 70 tagged Southern dogfish, post-capture mortality rate was estimated to be low, around 3 to 16 percent (Williams et al. 2013a). However, as part of this tagging study, steps were taken to maximize survivorship (such as restricting soak times to 2-4 hours and careful de-hooking and handling of the sharks) that may not be followed during commercial fishing operations (Williams et al. 2012). In fact, Williams et al. (2012) notes that soak times of up to 13.45 hours are more common during normal commercial fishing operations. Given the methods taken to maximize survivorship, as well as the fact that the study focused on Southern dogfish, we find that the estimates reported in Williams et al. (2012; 2013a) and referred to by the commenters may not be an accurate representation of post-capture survivorship for Harrisson's dogfish on ALL gear. As such, we find no reason to change our initial characterization of risk from incidental capture on ALL gear.

Comment 11: Since the publication of the proposed rule, there has been a reduction in ALL effort in the SESSF, with one boat leaving the fishery. There are now only two dedicated longline boats remaining in the fishery, as opposed to the three vessels considered in the proposed listing. Both of the remaining vessels have now been fitted with electronic monitoring systems which are required to monitor all fishing operations. This allows assessment of dogfish handling practices, as well as evaluation of the effectiveness of the industry code of conduct.

Response: We appreciate the new information and have updated the status review accordingly. After review, we do not find that the removal of this single vessel from the fishery would significantly change the overall conclusions of the extinction risk analysis.

Status reviews for the petitioned species addressed in this finding were conducted by NMFS staff. Separate draft status reviews were completed for the Banggai cardinalfish (Conant 2014) and Harrisson's dogfish (Miller 2014). In order to complete the status reviews, we compiled information on the species' biology, ecology, life history, threats, and conservation status from information contained in the petition, our files, a comprehensive literature search, and consultation with experts. We also considered information submitted by the public and peer reviewers. Prior to publication of the proposed rule, all status reviews were subjected to peer review. Peer reviewer comments are available at http://www.cio.noaa.gov/services_programs/prplans/PRsummaries.html.

The status review reports provide a thorough discussion of life history, demographic risks and threats to the particular species. We considered all identified threats, both individually and cumulatively, to determine whether the species responds in a way that causes actual impacts at the species level. The collective condition of individual populations was also considered at the species level, according to the four demographic viability factors discussed above.

The proposed rule (79 FR 74953, December 16, 2014) summarizes general background information on the natural history, range, reproduction, population structure, distribution and abundance of the Banggai cardinalfish and Harrisson's dogfish. All of that information is incorporated herein by reference. In addition, an update on the Banggai cardinalfish population abundance and conservation efforts (Vagelli unpublished report 2015) is available upon request (see FOR FURTHER INFORMATION CONTACT).

Based on the best available scientific and commercial information described above and in the status review reports, we have determined that the Banggai cardinalfish (Pterapogon kauderni) and Harrisson's dogfish (Centrophorus harrissoni) are taxonomically-distinct species and therefore meet the definition of “species” pursuant to section 3 of the ESA and are eligible for listing under the ESA.

Next we considered whether any one or a combination of the five threat factors specified in section 4(a)(1) of the ESA contribute to the extinction risk of these species. For Harrisson's dogfish, none of the information we received from public comment on the proposed rule affected our discussion or conclusions regarding any of the section 4(a)(1) factors or their interactions, so we incorporate the discussion of these factors from the proposed rule (79 FR 74953, December 16, 2014) by reference herein. For the Banggai cardinalfish, the report received from the peer review on the Banggai cardinalfish status review indicated that compliance with the Fish Quarantine regulations was largely voluntary and that improved trade practices had not been implemented (Vagelli unpublished report 2015). Thus, we are less certain that compliance and trade practices will improve in the future under the “inadequacy of existing regulatory mechanisms” threat factor.

None of the information we received from public comment on the proposed rule affected our extinction risk evaluation of Harrisson's dogfish. As such, our evaluation remains the same as in the original status review report and the discussion in the proposed rule (79 FR 74953, December 16, 2014), and that discussion is incorporated herein by reference. For the Banggai cardinalfish, as stated above, the report received from the peer review on the Banggai cardinalfish status review indicated that compliance with the Fish Quarantine regulations was largely voluntary and that improved trade practices had not been implemented (Vagelli unpublished report 2015). Thus, we are less certain that compliance and trade practices will improve in the future. However, the updated information on the inadequacy of existing regulatory mechanisms did not result in a higher risk of extinction because we previously had considered that enforcement was weak, and illegal, unregulated, and unreported capture and trade were still a major problem in the extinction risk assessment (Conant 2014).

Finally, we considered conservation efforts to protect each species and evaluated whether these conservation efforts are adequate to mitigate the existing threats to the point where extinction risk is significantly lowered and the species' status is improved. None of the information we received from public comment on the proposed rule affected any of our discussion or conclusions regarding conservation efforts to protect Banggai cardinalfish, so we incorporate the discussion of these efforts from the proposed rule (79 FR 74953, December 16, 2014) by reference herein.

For Harrisson's dogfish, we specifically requested information during the public comment process on the conservation efforts that were identified in the proposed rule (79 FR 74953; December 16, 2014) and their certainty of implementation and effectiveness. We received no comments or information on our conclusions regarding the effectiveness of the conservation efforts. As such, our discussion and conclusion from the proposed rule remains the same (and is incorporated herein by reference); namely, that the implemented conservation efforts are likely to improve the present status of the species by effectively decreasing the threat of overutilization by fisheries in the near term to the point where the species is no longer presently in danger of extinction.

We did receive information on the other aspect of our evaluation of conservation efforts, namely, the certainty of implementation of these conservation efforts. Specifically, we received information from the Australian Government, the organization in charge of implementing the conservation efforts. This information, as well as additional information collected during the comment period and our analysis of this new information, is discussed below.

In the proposed rule (79 FR 74954), we concluded that the regulatory measures from the Upper-Slope Dogfish Management Strategy (the “Strategy”; see AFMA, 2012), which the Australian Fisheries Management Authority (AFMA) implemented for the conservation of the species, were likely to be effective in improving the present status of the species. However, we also noted in the proposed rule that the certainty of the conservation efforts remaining in place after 5 years could not be predicted at this time. As such, we concluded that the time frame over which the conservation efforts would certainly be in place was insufficient to increase the species' chances of survival or prevent its extinction through the foreseeable future.

Our conclusion was primarily based on our understanding that the legal instrument (i.e., the “SESSF Fishery Closures Direction No. 1 2013”) used to implement the conservation efforts within the Strategy expires in 5 years, with no certainty of implementation of conservation efforts past this point in time. Additionally, we interpreted the listing of the species as “conservation dependent” under Australia's Commonwealth Environment Protection and Biodiversity Conservation Act 1999 (EPBC Act) to mean that it is not afforded protection by the EPBC Act because it is not considered to be a “matter of national significance.” However, upon review of the information received from the Australian Government, as well as information we collected during the comment period, briefly discussed below, we now have a high degree of certainty that conservation efforts will continue to be implemented beyond a 5-year period.

In Australia, Commonwealth fisheries are managed by AFMA, which is governed by the legislative objectives in Australia's Fisheries Management Act 1991 (FM Act). One of AFMA's main legislative objectives under the FM Act is “Ensuring that the exploitation of fisheries resources and the carrying on of any related activities are conducted in a manner consistent with the principles of ecologically sustainable development (which include the exercise of the precautionary principle), in particular the need to have regard to the impact of fishing activities on non-target species and the long-term sustainability of the marine environment” (FM Act subsection 3(1)(b)). In addition, AFMA also has the objective of “Ensuring, through proper conservation and management measures, that the living resources of the AFZ [Australian Fishing Zone] are not endangered by over-exploitation” (FM Act subsection 3(2)(a)).

In 1999, the EPBC Act was passed and is considered to be the key legislation for conserving the biodiversity of Australian ecosystems and protecting the natural environments that support these ecosystems. Broadly, the EPBC Act requires that fishing actions do not have a significant impact on the Commonwealth marine environment, including protected species or ecological communities. Objectives of the EPBC Act include providing for the protection of the environment, especially matters of national environmental significance (which includes Commonwealth marine areas), conserving Australian biodiversity, and promoting ecologically sustainable development through the conservation and ecologically sustainable use of natural resources.

Part of AFMA's obligations under the EPBC Act is the requirement to prepare strategic assessment reports for all Commonwealth fisheries, particularly those with an export component. These reports are prepared to address the Australian Government's Guidelines for the Ecologically Sustainable Management of Fisheries—2nd Edition, which specifies principles and objectives designed to ensure a strategic and transparent way of evaluating the ecological sustainability of fishery management measures. These reports also provide updates on the implementation of conditions and recommendations from the previous assessments of the fishery. These reports are then submitted to and assessed by Australia's Department of Environment for accreditation. The Department of the Environment ultimately evaluates the environmental performance of fisheries, including: The strategic assessment of fisheries under Part 10 of the EPBC Act; assessments relating to impacts on protected marine species under Part 13 of the EPBC Act; and assessments for the purpose of export approval under Part 13A of the EPBC Act.

This accreditation process is extremely important for the SESSF. As noted in the proposed rule, Harrisson's dogfish are primarily caught as bycatch by the SESSF, which operates over an extensive area of the AFZ around eastern, southern, and southwestern Australia. In fact, the management area covers almost half of the AFZ (Georgeson et al. 2014). In 2012-2013, the SESSF was the largest commonwealth fishery in terms of production value, and also the most valuable, with a gross value of production (GVP) of $91.8 million (28 percent of the total GVP for Commonwealth fisheries) (Georgeson et al. 2014). As such, ensuring that the SESSF is managed in an ecologically sustainable way so that commercial export of Australian native wildlife from this fishery may continue appears to be a priority for the Australian Government.

The most recent assessment of the SESSF occurred in 2013, before the EPBC Act listing of Harrisson's dogfish. However, in recognition of the decline in Harrisson's dogfish and the potential impacts that continued SESSF operations may have on the shark, the Department of Environment recommended that the accreditation be subject to a number of conditions that must be addressed by AFMA within the period of the approved wildlife trade operation declaration for the fishery. For Harrisson's dogfish, these conditions were: (1) Implement long-term management measures, including fisheries closures and other actions, that are clearly directed towards stopping the decline and supporting the recovery of Harrisson's dogfish and southern dogfish, and (2) continue, in consultation with relevant experts, to monitor and review the adequacy of management measures designed to stop the decline and support the recovery of Harrisson's dogfish and southern dogfish (Department of Environment 2013). On February 25, 2013, Australia's Minister for the Environment officially declared the harvest operations of the SESSF an approved wildlife trade operation but subject to a number of conditions, including the ones concerning Harrisson's dogfish stated above (Commonwealth of Australia Gazette S 30; 25 February 2013). This approval is valid until February 25, 2016, at which point the SESSF will have to be re-assessed to ensure the sustainability of the fishery, including AFMA's progress on meeting the conditions from the approval declaration.

The state-managed New South Wales Ocean, Trap, and Line Fishery (OTLF) and Ocean Trawl Fishery (OTF) also potentially bycatch Harrisson's dogfish and were assessed in March and May 2014, respectively, after Harrisson's dogfish was listed as conservation dependent under the EPBC Act. Similar to the conditions set forth for the SESSF accreditation, the OTLF and OTF are also subject to conditions for protecting Harrisson's dogfish. Specifically, the New South Wales Department of Primary Industries, in consultation with AFMA, must: (1) Maintain long-term management measures that are clearly directed towards stopping the decline and supporting the recovery of Harrisson's dogfish and southern dogfish, and (2) continue, in consultation with relevant experts, to monitor and review the adequacy of management measures designed to stop the decline and support the recovery of Harrisson's dogfish and southern dogfish (Commonwealth of Australia Gazette C2014G00735; 8 May 2014 (OTLF); C2014G01029; 20 June 2014 (OTF)). These approvals are valid for 3 years, after which, again, the fisheries must be re-assessed to ensure ecological sustainability. If any of these fisheries fail to follow the conditions set forth in the wildlife trade operation declaration, then they would be prohibited from exporting products derived from the fishery, essentially shutting down the fishery operations.

To meet the approval conditions and satisfy the management requirements for a conservation dependent listing under the EPBC Act (TSSC 2013), AFMA identified and implemented fishery management measures in the Strategy that were deemed necessary to stop the decline of, and support the recovery of, the species so that its chances of long term survival in nature are maximized. In the proposed rule, we determined that these conservation efforts would be effective at preventing the extinction of Harrisson's dogfish (see 79 FR 74954, discussion of Harrisson's Dogfish Protective Efforts). These measures have ultimately been given legal effect through legislative instruments under the FM Act, including the Fishery Closure Direction (“SESSF Fishery Closures Direction No. 1 2013”). Although the current closure direction will expire in 5 years (which is the longest time period that closure directions are in effect; G. Day, AFMA, personal communication 2014), the objectives of and requirements under the FM Act and the EPBC Act (as stated above) compel ongoing management measures to be implemented to protect Harrisson's dogfish from extinction through the foreseeable future.

To assist with these ongoing conservation efforts, AFMA published the “Upper-Slope Dogfish Management Strategy Research and Monitoring Workplan,” (“Workplan”; AFMA 2014) which uses the principles of adaptive management to assess the effectiveness of the Strategy in stopping the decline of and promoting the rebuilding of Harrisson's dogfish. According to the Workplan, the scheduled periodic reviews of its outcomes “provides for a feedback loop whereby arrangements in the Strategy can be adapted as necessary to meet developments in the fishery and the improved understanding of Harrisson's dogfish biology and stock structure” (AFMA 2014). The Workplan also outlines explicit incremental objectives for the conservation effort, steps needed to achieve the objectives, timeframes associated with the steps, as well as performance indicators, monitoring mechanisms and progress reporting on the implementation and evaluation of the success of the objectives.

Given the implementation of current conservation efforts, with a published Workplan that allows for the continued monitoring and reporting on the implementation and effectiveness of these conservation efforts, as well as legislative obligations that compel these efforts, we find there to be a high likelihood that management measures for the protection of Harrisson's dogfish will continue to be implemented through the foreseeable future. As noted by the Australian Government in their public submission, “following the expiration of the current Closure Direction, management measures will be reviewed and subsequent spatial closure decisions or other conservation efforts will be implemented for the protection of Harrisson's Dogfish in light of the performance of the Strategy against its objectives and the objectives of the FM Act and EPBC Act.” Based on the above, we have determined that the conservation efforts protecting Harrisson's dogfish from risk of extinction through the foreseeable future have a high certainty of being implemented.

In the proposed rule we also noted that the protection of the species is not required under the EPBC Act due to its conservation dependent status. However, as noted above, there are a number of legislative protections for Harrisson's dogfish. In addition, although the species is not directly characterized as a matter of national significance due to its conservation dependent status under the EPBC Act, the species is indirectly protected by the EPBC Act through the designation of Commonwealth Marine Areas as matters of national significance. Under this designation, an action that is likely to have a substantial adverse effect on a population of a marine species (such as Harrisson's dogfish), including its life cycle (for example, breeding, feeding, migration behavior, life expectancy) and spatial distribution, is considered to have a significant impact on the environment in a Commonwealth Marine Area and must be referred to Australia's Minister of the Environment and undergo an environmental assessment and approval process. This is an additional protection afforded to Harrisson's dogfish under the Australian Government's legal framework that was not considered in the proposed rule.

In light of the new information received and collected during the public comment period regarding Australia's legislative objectives, requirements, and actions, especially as they pertain to Harrisson's dogfish, we no longer find that the timeframe over which conservation efforts will certainly be in place is insufficient to increase the species' chances of survival or prevent its extinction through the foreseeable future. Rather, we now have a high degree of certainty that conservation efforts to protect the species from further decline (and with the primary objective of rebuilding) will continue to be implemented after 5 years and through the foreseeable future, effectively mitigating existing threats to the species and improving the status of the species to the point where extinction is unlikely now or in the foreseeable future.

We have reviewed the best available scientific and commercial information, including the petition, the information in the status review reports, public comments, and the comments of peer reviewers. Based on the information presented, we find that the Banggai cardinalfish (Pterapogon kauderni) is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. We assessed the ESA section 4(a)(1) factors and demographic risk factors and conclude that habitat destruction and overutilization affect Banggai cardinalfish. After considering efforts being made to protect Banggai cardinalfish, we could not conclude that the proposed conservation efforts would alter the extinction risk for the species. Therefore, we are listing the Banggai cardinalfish as threatened under the ESA.

Based on the information presented, we find that Harrisson's dogfish is not in danger of extinction, or likely to become so in the foreseeable future, throughout all or a significant portion of its range. We assessed the ESA section 4(a)(1) factors and demographic risk factors and conclude that Harrisson's dogfish faces threats from overutilization, with the species' natural biological vulnerability to overexploitation and demographic risks exacerbating the severity of the threats. However, we also conclude that ongoing conservation efforts implemented by the Australian Government are currently effective in decreasing this main threat of overutilization to the point where the species is not presently in danger of extinction. In addition, we conclude that these conservation efforts are sufficiently certain to be implemented and effective over a timeframe necessary to stop the decline of, and support recovery of, the species so that its chances of long term survival in nature are maximized, thereby making it unlikely that the species will become in danger of extinction in the foreseeable future. Therefore, we find that listing Harrisson's dogfish as an endangered or threatened species under the ESA is not warranted at this time.

We will continue to monitor the status of Harrisson's dogfish and if, at any time, data indicate that protective status under the ESA may be necessary and should be considered again, including information that the implementation of necessary conservation efforts has ceased, or if we become aware of noncompliance issues with the conservation measures, or if there are new or increasing threats, we can initiate listing procedures, including, if appropriate, emergency listing pursuant to section 4(b)(7) of the ESA.

Conservation measures provided for species listed as endangered or threatened under the ESA include recovery actions (16 U.S.C. 1533(f)); concurrent designation of critical habitat, if prudent and determinable (16 U.S.C. 1533(a)(3)(A)); Federal agency requirements to consult with NMFS under section 7 of the ESA to ensure their actions do not jeopardize the species or result in adverse modification or destruction of critical habitat should it be designated (16 U.S.C. 1536); and prohibitions on taking (16 U.S.C. 1538). Recognition of the species' plight through listing promotes 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/USFWS regulations require Federal agencies to consult with us to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of listed species or destroy or adversely modify critical habitat. It is unlikely that the listing of the Banggai cardinalfish under the ESA will increase the number of section 7 consultations, because this species occurs outside of the United States and is unlikely to be affected by Federal actions.

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 upon a determination that such areas are 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 (16 U.S.C. 1532(3)). Section 4(a)(3)(A) of the ESA (16 U.S.C. 1533(a)(3)(A)) requires that, to the extent prudent and determinable, critical habitat be designated concurrently with the listing of a species. However, critical habitat shall not be designated in foreign countries or other areas outside U.S. jurisdiction (50 CFR 424.12 (h)).

The best available scientific and commercial data as discussed above identify the geographical areas occupied by Pterapogon kauderni as being entirely outside U.S. jurisdiction, so we cannot designate critical habitat for this species. We can designate critical habitat in areas in the United States currently unoccupied by the species, if the area(s) are determined by the Secretary to be essential for the conservation of the species. Based on the best available information, we have not identified unoccupied area(s) in U.S. waters that are currently essential to the conservation of the Banggai cardinalfish. Therefore, based on the available information, we will not designate critical habitat for Pterapogon kauderni.

Section 9 of the ESA prohibits the take of endangered species. The term “take” means 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)). In the case of threatened species, ESA section 4(d) leaves it to the Secretary's discretion whether, and to what extent, to extend the section 9(a) “take” prohibitions to the species, and authorizes us to issue regulations necessary and advisable for the conservation of the species. Thus, we have flexibility under section 4(d) to tailor protective regulations, taking into account the effectiveness of available conservation measures. The 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. These section 9(a) prohibitions apply to all individuals, organizations, and agencies subject to U.S. jurisdiction. We will consider potential protective regulations pursuant to section 4(d) for the Banggai cardinalfish in a future rulemaking.

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

The 1982 amendments to the ESA, in section 4(b)(1)(A), restrict the information that may be considered when assessing species for listing. Based on this limitation of criteria for a listing decision and the opinion in Pacific Legal Foundation v. Andrus, 675 F. 2d 825 (6th Cir. 1981), NMFS has concluded that ESA listing actions are not subject to the environmental assessment requirements of the National Environmental Policy Act (NEPA) (See NOAA Administrative Order 216-6).

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 therefore a Federalism assessment is not required.

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

The snapper-grouper fishery of the South Atlantic includes greater amberjack and is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) by regulations at 50 CFR part 622.

The commercial quota (equivalent to the commercial ACL) for greater amberjack in the South Atlantic is 769,388 lb (348,989 kg), gutted weight, as specified in 50 CFR 622.190(a)(3).

Under 50 CFR 622.193(k)(1), NMFS is required to close the commercial sector for greater amberjack when the commercial quota (commercial ACL) is reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS projects that commercial landings of South Atlantic greater amberjack will reach the commercial ACL by January 21, 2016. Accordingly, the commercial sector for South Atlantic greater amberjack is closed effective 12:01 a.m., local time, January 21, 2016, until 12:01 a.m., local time, March 1, 2016.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper with greater amberjack on board must have landed and bartered, traded, or sold such greater amberjack prior to 12:01 a.m., local time, January 21, 2016. During the commercial closure, harvest and possession of greater amberjack in or from the South Atlantic EEZ is limited to the bag and possession limits, as specified in § 622.187(b)(1) and (c)(1). Also during the commercial closure, the sale or purchase of greater amberjack taken from the South Atlantic EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of greater amberjack that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, January 21, 2016, and were held in cold storage by a dealer or processor, as specified in § 622.190(c)(1)(i).

For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the bag and possession limits and the sale and purchase provisions of the commercial closure for greater amberjack would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.190(c)(1)(ii).

The Regional Administrator, Southeast Region, NMFS, has determined this temporary rule is necessary for the conservation and management of greater amberjack and the South Atlantic snapper-grouper fishery and is consistent with the Magnuson-Stevens Act and other applicable laws.

This action is taken under 50 CFR 622.193(k)(1) and is exempt from review under Executive Order 12866.

These measures are exempt from the procedures of the Regulatory Flexibility Act, because the temporary rule is issued without opportunity for prior notice and comment.

This action responds to the best scientific information available. The Assistant Administrator for Fisheries, NOAA (AA), finds that the need to immediately implement this action to close the commercial sector for greater amberjack constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures are unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure. Such procedures are contrary to the public interest because of the need to immediately implement this action to protect greater amberjack since the capacity of the fishing fleet allows for rapid harvest of the commercial ACL (commercial quota). Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established commercial ACL (commercial quota).

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).