Under the Virus-Serum-Toxin Act (the Act, 21 U.S.C. 151-159) and regulations issued under the Act, the Animal and Plant Health Inspection Service (APHIS) grants licenses or permits for biological products which are pure, safe, potent, and efficacious when used according to label instructions. The regulations in 9 CFR part 112, “Packaging and Labeling” (referred to below as the regulations), prescribe requirements for the packaging and labeling of veterinary biological products including requirements applicable to final container labels, carton labels, and enclosures. The main purpose of the regulations in part 112 is to regulate the packaging and labeling of veterinary biologics in a comprehensive manner, which includes ensuring that labeling provides adequate instructions for the proper use of the product, including vaccination schedules, warnings, and cautions. Complete labeling (either on the product or accompanying the product) must be reviewed and approved by APHIS in accordance with the regulations in part 112 prior to their use.

Although the science of immunology and our understanding of how veterinary biologics work have advanced substantially in recent years, communicating such information to consumers by way of updated labeling claims, cautions, and warnings has not kept pace. Therefore, we are proposing to amend several sections of the regulations in part 112 to make veterinary biologics labeling requirements more consistent with current science and veterinary practice.

We are proposing to amend § 112.2(a)(1) of the regulations concerning required labeling information to provide for the use of an abbreviated true name on labeling for small final containers of veterinary biologics. Currently, the regulations require the true name shown in the product license or permit under which a product is imported to be used in veterinary biologics labeling. However, due to the small size of the labeling used on small final containers of some veterinary biologics and the amount of label surface that must be devoted to emphasizing the true name of the product, there may not be adequate remaining space on such labeling for the legible presentation of other required information. Under the proposed amendment, when issuing or reissuing licenses for veterinary biologics, APHIS would assign abbreviated true names-shortened forms of the true name of the product shown in the product license/permit—which may be used in place of the long form of the true name on labeling for small final containers of veterinary biologics. While abbreviated true names may be used on small final container labels, the complete true name along with the abbreviation for such true name would be shown on carton labels and enclosures. Thus, the association between the true name of the product and its abbreviated true name would be readily apparent to consumers, veterinarians, and others who utilize veterinary biological products. The proposed change would mean that a greater proportion of the (small) container label surface may be used to improve the presentation and legibility of other required information. The proposed amendment also would clarify in this section the requirements for showing the true name of the product and/or a functional or chemical name for the reagent on labeling for cartons, and containers of interchangeable (non-critical) reagents included in diagnostic test kits. Carton or box labeling for diagnostic test kits is required to show the true name of the test kit as it appears on the product license or permit under which such kit is imported; labeling for containers of interchangeable reagents included in test kits may show the functional and/or chemical name of such reagent(s). The proposed change would facilitate the use of a single lot of such interchangeable reagent in a variety of test kit configurations.

We are proposing to amend the regulations in § 112.2(a)(2) to require labeling for veterinary biologics to bear a telephone number that consumers may use to contact the licensee or permittee to report adverse events or other unfavorable experiences associated with the use of such products. Currently, veterinary biologics labeling is not required to bear a telephone number for reporting adverse experiences to APHIS and/or the licensee or permittee. In the absence of immediately available contact information for reporting such adverse experiences, the probability of harm to animals and hazards to humans posed by the use of veterinary biologics may increase. The addition to veterinary biologics labeling of a telephone number that consumers may use to report adverse events and other unfavorable experiences to the manufacturer and to APHIS would facilitate the reporting of such adverse vaccine experiences and help to ensure that the licensee/permittee is able to initiate appropriate corrective action in a timely manner.

In order to better facilitate product identification, we are proposing to amend the regulations in § 112.2(a)(3) to: (1) Require labeling for veterinary biologics to bear the product code number (PCN) that APHIS assigns to such product and communicates to the manufacturer when the product license application is submitted, and (2) specify a revised format for showing the veterinary establishment license number (VLN) or veterinary establishment permit number (VPN) in veterinary biologics labeling. The license or permit number would be shown side-by-side with the product code number using the format VLN/PCN or VPN/PCN, as applicable. For example, the VLN/PCN relationship for a product prepared by veterinary biologics licensee number 100 (VLN 100) under product code number 1A34.XX (PCN 1A34.XX) would be shown in labeling as: VLN/PCN 100/1A34.XX. Currently, the regulations in § 112.2(a)(3) specify that the license number must be shown in labeling as “U.S. Veterinary License No. _,” or “U.S. Vet License No. _,” or “U.S. Vet Lic. No. _,” and the permit number must be shown as “U.S. Veterinary Permit No. _,” or “U.S. Permit No. _,” but there is no requirement for the PCN to appear in labeling. The true name of the product, the veterinary license or permit number, and the product serial or lot number, all currently required to be shown in labeling, are used for product identification. In most instances, such information is sufficient for product identification. However, such information may be insufficient if the licensee or permittee prepares or distributes two or more products that have the same true name and use an overlapping sequence of serial numbers; in those instances, consumers may need additional information in order to accurately identify a product. The addition of the PCN to veterinary biologics labeling would provide that additional piece of information. The side-by-side presentation of the VLN/VPN and PCN in veterinary biologics labeling, along with the true name of the product and its serial or lot number, would better facilitate product identification and help to ensure the accuracy of information provided to the manufacturer and/or APHIS concerning product performance.

We are proposing to amend the regulations in §§ 112.2(a)(4) and 114.11 regarding the storage temperature recommendation for veterinary biologics to prescribe a range of 2 to 8 °C (35 to 46 °F) as the recommended storage temperature for both released serials of veterinary biologics stored in distribution channels and completed serials of veterinary biologics stored at a licensed establishment. Currently, the regulations provide that the storage temperature for veterinary biological product in distribution channels should be stated as “not over 45 °F or stated as not over 7 °C or stated as not over 45 °F or 7 °C.” The regulations do not prescribe a minimum recommended storage temperature for released product in distribution channels. Under § 114.11 of the regulations, completed product stored at licensed establishments should be kept under refrigeration at temperatures that may range from 35 to 45 °F (2 to 7 °C). Under the proposed amendment, the maximum recommended storage temperature for released product in distribution channels would increase to 8 ΕC (the widely recognized standard, and 1 °C above the currently prescribed 7 °C), and 2 °C would be established as the minimum recommended storage temperature. For completed product stored in bulk or final containers at licensed establishments, the minimum recommended storage temperature of 2 °C would remain unchanged, and the maximum recommended storage temperature would be increased to 8 °C (1 °C above the currently prescribed 7 °C). The proposed amendment would standardize veterinary biologics storage temperature recommendations in the regulations and, thereby, reduce the likelihood that dissimilar recommendations may result in mishandling during storage.

We propose to amend the regulations in § 112.2 (a)(5) to clarify that “full instructions for the proper use of the product” refers to vaccination schedules, revaccination schedules (if necessary), indications for use, target species, recommended age for vaccination, vaccination route(s), and product license restrictions prescribed by APHIS that have a bearing on product use. Currently, the regulations in § 112.2(a)(5) specify that “full instructions for the proper use of the product” refers to “vaccination schedules, warnings, cautions, and the like.” Although APHIS has always considered indications for use, target species, age of vaccination, route of vaccination, and product license restrictions to be included under “full instructions for the proper use of the product,” the fact that such information is not specifically identified as “required” in the regulations may have caused some confusion with regard to interpretation, which resulted in requests for clarification from licensees and permittees. The proposed amendment would ensure consistency in labeling by setting forth under the regulations the minimum information that must be provided under instructions for use of the product.

We are proposing to amend the regulations in §§ 112.2(a)(7) and 112.3(f)(2) to require chemical treatment prior to disposal of containers of veterinary biologics containing viable or dangerous organisms or viruses. In addition, under § 112.2(a)(7) of the regulations, the proposed amendment would require labeling to bear statements that: (1) Warn persons who inject themselves with veterinary biologics to seek medical attention and, (2) warn against treating animals with mixtures of veterinary biologics that are not approved for administration as combination products. Currently, the regulations require labeling to bear the warning “Burn this container and all unused contents” if a biological product contains viable or dangerous organisms or viruses. At the time the regulation was promulgated, disposal of discarded veterinary biologics containers by burning was in accordance with existing environmental guidelines. At this time, however, environmental guidelines in many States prohibit disposal of potentially environmentally harmful materials by burning. The proposed amendment would update the regulations by specifying chemical inactivation as the method for ensuring that the unused contents of vaccine containers are made non-hazardous prior to disposal.

With regard to the use of unapproved combinations of veterinary biologics in the treatment of animals and what constitutes an appropriate course of action in the event of accidental self injection of a veterinary biologic, the regulations do not currently address either topic. In the case of using unapproved combinations of veterinary biologics in the treatment of animals, many veterinarians (and consumers) have made “judgment” decisions to inoculate animals using mixtures of two or more veterinary biologics that are not approved for administration as combination products. In addition to the fact that such mixing of product(s) is not recommended in labeling, such off-label use disregards the important consideration that antigen interference, a frequent occurrence when administering two or more antigens concurrently, may render the combined products ineffective and could present a disease and/or safety risk in animals. A label statement warning against administering unapproved combinations of veterinary biologics to animals would ensure that veterinary professionals and consumers have the information necessary to use veterinary biologics in a safe and effective manner. We propose to require labeling to bear a statement advising users to seek medical attention should they accidentally inject themselves with veterinary biologics because such products frequently contain chemical compounds that may cause serious injury or harm when left untreated. We believe that it is prudent to make consumers aware of the possibility of serious injury as a result of accidental injection of a veterinary biologic, and encourage such persons to seek immediate medical attention.

We are proposing to amend the regulations in § 112.2(a)(10) to require labeling to indicate the presence of non-antibiotic preservatives (anti-infective substances) added during the preparation of veterinary biologics. Currently, the regulations only require labeling to disclose the presence of antibiotics added at preservative levels during the production process. Such disclosure may help to identify, and aid in testing for drug residues that may be present in the edible portions of food-producing animals that are treated with veterinary biologics. In addition to antibiotic preservatives, many veterinary biologics also may contain non-antibiotic preservatives that are added during the production process. Non-antibiotic preservatives also may cause residues in food, unfavorable reactions in animals, and/or environmental harm. The proposed amendment would treat non-antibiotic preservatives added during the production process the same as antibiotic preservatives, and require labeling disclosure. Antibiotic preservatives used in the reagents that are included in diagnostic test kits would be exempted from this labeling requirement because they are not administered to animals and would not be expected to cause food residues. The proposed amendment would ensure that all anti-infective substances with the potential to cause harm would be disclosed in labeling.

We are proposing to amend the regulations in § 112.2(d)(3) to provide that carton labels and enclosures for veterinary biologics may bear the statement “For animal use only” in place of the statement “For veterinary use only.” Currently, the regulations specify that veterinary biologics labeling may bear the statement “For veterinary use only” or an equivalent statement when referring to product that is recommended specifically for animals, and not for humans. However, “For veterinary use only” is often confused with the similar statement in the regulations, “Restricted to use by or under the direction of a veterinarian,” which is required to be shown on labeling for products that have a restriction on the license specifying use by or under the direction of a veterinarian. Typically, special knowledge and/or expertise is not required when using veterinary biologics labeled for “animal use only,” whereas professional training and/or knowledge may be required for proper use of veterinary biologics that are labeled “restricted to use by or under the direction of a veterinarian.” For example, veterinary biologics for use in animal disease control and eradication and wildlife vaccination programs may be restricted to use by or under the direction of a veterinarian because of concern about disease spread and/or public health implications. The proposed amendment would help to clarify the distinction between product recommended for use in animals and product that should only be administered by or under the direction of a veterinarian.

We are proposing to amend the regulations in § 112.2(e) pertaining to the approval of special labels for use on biological products to be exported to a foreign country to specify that when the labeling requirements of a foreign country conflict with the requirements prescribed in the regulations in 9 CFR part 112, such request for the approval of special labeling for use on product to be exported must be accompanied by a signed document issued by the appropriate regulatory official of the importing country that affirms the need for such special labeling in order to satisfy the country's regulatory requirements. As a condition for the approval, we would specify that such special labeling may not contain false or misleading information. Currently, the regulations provide for the approval of special labels for use on biological products for export to a country in which labeling requirements conflict with the requirements of the United States; however, the regulations do not prescribe the requirements for obtaining approval of such special labeling. The proposed amendment would clarify the procedure for obtaining approval of special labeling for veterinary biological product for export.

We are proposing to amend the regulations in § 112.2(f) to specify that when carton tray covers are used to show required labeling information concerning veterinary biologics, all such information should appear on the outer face of the tray cover where it can be read without opening the carton. Currently, the use of carton tray covers to show required labeling information is not addressed under the regulations concerning packaging and labeling. However, carton tray covers have come to be extensively used in the packaging of diagnostic test kits. Frequently, such tray covers may be used for the presentation of required labeling information; and some firms have been placing required information on both the outer and inner faces of the tray covers. In such situations, information on the inner face of the tray cover cannot be read by the consumer because of its placement. The proposed change would ensure that required labeling information shown on carton tray covers is presented in a manner that is accessible to the consumer and consistent with the requirements in the regulations that pertain to other labeling media.

We are proposing to amend the regulations in § 112.5(c)(2) to specify additional minor changes that may be made to labeling for products with approved labels or master labels without prior approval from APHIS. The minor label changes that may be made include changes to labeling background color that do not affect legibility of the label; changing the telephone number used to contact the licensee or permittee; changing or revising an e-mail or Web site address; changing the name and/or address of a distributor; or adding, revising, or repositioning universal product code bars or other inventory control numbers. Changes to the name and/or address of the licensee or permittee and changes to the Veterinary License Number or Veterinary Permit Number that are made pursuant to the reissuance of an Establishment License or Product Permit by APHIS also would be considered minor label changes. Currently, § 112.5 of the regulations specifies that labeling for veterinary biological product must be submitted to APHIS for review for compliance with the regulations and approval in writing prior to use. In § 112.5, paragraph (c) provides that certain minor changes may be made in labels for products with approved labels or master labels, and the revised labels may be used prior to review by APHIS if the specified requirements are met. In § 112.5, paragraph (c)(2) provides a listing of such minor changes that may be made to approved labels and master labels. The proposed amendment would specify additional minor changes to labeling that need not be submitted to APHIS for review and written approval prior to use and, thereby, help to reduce and/or eliminate marketing delays.

We are proposing to amend the regulations in §§ 112.5(d)(1)(iii) and (iv) and 103.3(d) to specify that only two copies of each finished final container label, carton label, enclosure, and experimental label should be submitted for APHIS review and approval. Currently, the regulations require three copies of each finished final container label, carton label, enclosure, and experimental label to be submitted. The third copy of labeling is no longer needed as the result of a restructuring of the Center for Veterinary Biologics.

Currently, the regulations in § 112.5(d)(4) require that the reason for, and information relevant to, the submission of labels and sketches be added to the bottom of each page of label mounting sheets for the purpose of facilitating label review. The designations of label specimens are to be presented as:

• Master label dose sizes approved for code ___.

• Replacement for label, master label, and/or sketch No. ___.

• Reference to label or master label No. ___.

• Addition to label No. ___.

• License Application Pending ___.

• Foreign language copy of label No. ___.

We would amend paragraph (d)(4) of § 112.5 to make it clear that only the applicable designation or designations, and not all of them, need to appear at the bottom of the label mounting sheets. In addition, we would reduce the number of designations by combining some and eliminating others. Specifically, the specimen designations “Reference to label or master label No.” and “Addition to label No.” would be combined into a single “Refer to APHIS-assigned label number” designation, and the “License Application Pending” and “Foreign Language copy of Label No.” designations would be removed. These proposed amendments would clarify the regulations with regard to specimen designation and facilitate a more efficient label submission and review process.

We are proposing to amend the regulations in § 112.5(e) pertaining to special requirements for foreign language labels to require that an accurate English translation be provided with all foreign language labeling submitted for review and approval. The proposal also would require that the foreign language text of multilingual labeling for a veterinary biological product distributed in the United States must be an accurate translation of the approved English text. Currently, the regulations in § 112.5(e)(1) and (e)(2) provide, respectively, that either the addition of a statement affirming the wording of the foreign language label to be a direct translation from a corresponding domestic label, or the submission of an English version of the foreign language label with an explanation for the difference in texts may be used to certify that foreign language text in labeling complies with the regulations. Under the proposed amendment, the option to either affirm the foreign language label to be a direct translation of an approved domestic label or explain the difference in the English and foreign language text would be removed from the regulations. Instead, all foreign language labels would be required to include an accurate English translation and a statement affirming the accuracy of such translation that APHIS would keep on file.

The presence of foreign language text in labeling for product intended for domestic distribution is not currently addressed in the regulations. However, foreign language text and its translation have become a domestic labeling issue due to the implementation of multilingual labeling by multinational firms that market globally and the fact that such foreign language text may not translate word for word into English. The proposed amendment would standardize the presentation of information in multilingual labeling and help to facilitate the timely resolution of questions concerning approved labeling content.

We propose to amend the regulations in § 112.6(a) pertaining to the packaging of biological products by removing a requirement which specifies that multiple-dose final containers of veterinary biological products that require a diluent for administration must be packaged in an individual carton with a container of the proper volume of diluent for that dose. Currently, the regulations require multiple-dose containers of veterinary biologics to be packaged in individual containers in order to ensure that vaccine will be used within a reasonable time after reconstitution in order to prevent a significant loss of vaccine potency. This requirement was promulgated when much less was known about the stability of vaccines, and it was assumed that vaccine would lose potency after dilution faster than animals could be treated. However, advances in vaccine technology, improved husbandry practices, and new methods for administering vaccines have made the continued imposition of this requirement an unnecessary burden on the veterinary biologics industry.

Currently, the regulations in § 112.7 provide for labeling requirements that are “additional to” the labeling requirements prescribed elsewhere in 9 CFR part 112. These additional labeling requirements are only applicable to products that have characteristics which make the “special requirements” necessary. Paragraph (f) of § 112.7 requires that, unless otherwise authorized in a filed Outline of Production, labels for inactivated bacterial products shall contain an unqualified recommendation for a repeat dose to accomplish primary immunization to be given at an appropriate time interval. Similarly, paragraph (i) of that section has the special requirement that labels for feline panleukopenia vaccines shall include a recommendation for annual revaccination of cats.

Such recommendations for annual boosters and/or revaccination are predicated on the premise that the protective immunity achieved with the primary immunization diminishes with time and, in order to ensure continued protection, animals must be revaccinated; the typical recommendation is to revaccinate annually. Although all veterinary biologics must be shown to provide protective immunity prior to the issuance of a license, firms have not been required, except for rabies vaccines, to provide data to establish the duration of protective immunity and/or the need for and frequency of revaccination to maintain such immunity. Despite not having demonstrated that revaccination is needed, it is now common practice for veterinary biologics labeling to recommend annual booster vaccinations for most products. Consequently, for products that were licensed without duration of immunity data, the need for annual revaccination is uncertain, and may not benefit the animal under certain circumstances. In fact, annual revaccination may be harmful in some situations such as with administering feline panleukopenia vaccine to cats annually. Alternatively, it could be that optimal protection of the animal requires that booster vaccinations be administered more frequently that on an annual basis.

In the absence of data, it is difficult or impossible to prescribe the appropriate revaccination interval for the animal. Thus, we are proposing to amend § 112.7(f) to require annual booster (annual revaccination) recommendations in labeling to be supported by data acceptable to APHIS. If such data are not available, we would require labeling to bear the following statement: “A specific revaccination schedule has not been established for this product; consultation with a veterinarian is recommended.” In keeping with the above proposed requirement that annual revaccination recommendations should be based on a demonstrated need for same, we would also amend § 112.7(i) by removing the recommendation for annual revaccination of cats with feline panleukopenia vaccine.

We are also proposing to amend § 112.7 to require that labeling for all modified live and inactivated vaccines for use in mammals bear an appropriate statement concerning the use of the product in pregnant animals. Currently, the regulations in § 112.7(e) require that labeling for (infectious) bovine rhinotracheitis (IBR) vaccine containing modified live virus bear the statement: “Do not use in pregnant cows or calves nursing pregnant cows” unless the vaccine has been shown to be safe for use in pregnant cows and has been exempted from the labeling requirement by the Administrator. The purpose of the warning statement concerning use in pregnant animals is to inform users of the risk to the developing fetus should pregnant cows be treated with or exposed to IBR vaccine containing modified live virus. We would extend the requirement for such a warning statement to bovine virus diarrhea vaccine (BVDV) containing modified live virus.

For IBR vaccine containing modified live virus and BVDV containing modified live virus, labeling would have to bear the statement “Do not use in pregnant animals or in calves nursing pregnant animals.” However, the current exemption found in § 112.7(e) that states that a vaccine that has been shown by data acceptable to APHIS to be safe for use in pregnant animals may be exempted from this label requirement would remain. It should be noted that even when an exemption is granted, the label would still have to include a statement concerning residual risks, i.e.: “Fetal health risks associated with the vaccination of pregnant animals with this vaccine cannot be unequivocally determined during clinical trials conducted for licensure. Appropriate strategies to address the risks associated with vaccine use in pregnant animals should be discussed with a veterinarian.”

In the case of other modified live and inactivated vaccines, we would require that the labeling bear a statement that is appropriate to the level of safety that has been demonstrated in pregnant animals. For example, a statement such as “Do not use in pregnant animals” or “Unsafe for use in pregnant animals” would be an appropriate statement for a product that scientific evidence has shown to be unsafe in pregnant animals. For products that do not have safety documentation acceptable to APHIS, but are not known to be unsafe, the labeling would have to include the statement “This product has not been evaluated for safety in pregnant animals” or an equivalent statement that is acceptable to APHIS.

The extension of such a warning statement to labeling for BVDV, and the proposal that both IBR vaccine and BVDV bear a residual risk statement concerning the reliability of data developed during limited clinical trials in pregnant animals would be new requirements. APHIS is proposing to require labeling for BVDV containing modified live virus to bear this warning in response to reports in the veterinary literature showing that vaccination and/or exposure of pregnant cows to BVDV represents a risk to the developing fetus similar to that of IBR vaccine containing modified live virus. In proposing to require labeling for vaccine for use in pregnant animals to bear a residual risk safety statement, APHIS is responding to concerns expressed within the veterinary community about vaccine safety. The proposed amendment acknowledges the safety and risk considerations associated with vaccine use and would convey such considerations to consumers.

Currently, the regulations in § 112.7(l) require that all labels for autogenous biologics bear the statement “Potency and efficacy of autogenous biologics have not been established. This product is prepared for use only by or under the direction of a veterinarian or approved specialist,” but there is no requirement for the label to identify the microorganism(s) used in the preparation of the product and the animal species for which the product is recommended. However, for all other veterinary biologics, the identity of the microorganism(s) and/or antigen(s) used in the preparation of the product and the species of animal for which it is intended are incorporated into the true name and indications for use statement shown in the labeling. We would amend § 112.7(l) to require that labeling for autogenous biologics identify the microorganism(s) used in its preparation, and the species for which it is prepared. This proposed change would standardize veterinary biologics labeling requirements across product categories.

The regulations in § 102.6(c) set forth the requirements for the issuance of conditional licenses. These requirements include a restriction which specifies that “Labeling for the [conditionally licensed] product may be required to contain information on the conditional status of the license.” This restriction prescribes a special requirement applicable to labeling for conditionally licensed product, and therefore should be included in the packaging and labeling requirements specified in 9 CFR part 112. We would amend the regulations in § 112.7 by adding a new paragraph (o) to require that labeling for all conditionally licensed products must bear the statement, “This product license is conditional, efficacy and/or potency requirements have not been completed.” This proposed requirement would ensure that consumers receive clear information regarding a product's conditionally licensed status.

If adopted, veterinary biologics manufacturers would have 3 years to bring all of their product labeling into compliance with the rule.

This proposed rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.

For this proposed rule, we have prepared an economic analysis. The analysis, which is set out below, provides a cost-benefit analysis, as required by Executive Order 12866, as well as an initial regulatory flexibility analysis that considers the potential economic effects of this proposed rule on small entities, as required by the Regulatory Flexibility Act (RFA, 5 U.S.C. 601 et seq. ).

This proposed rule would amend the Virus-Serum-Toxin Act regulations regarding the packaging and labeling of veterinary biological products to provide for the use of an abbreviated true name on small final container labeling for veterinary biologics; require labeling to bear a consumer contact telephone number; change the format used to show the veterinary biologics establishment or permit number on labeling and require such labeling to show the product code number; change the storage temperature recommended in labeling for veterinary biologics; require vaccination and revaccination recommendations in labeling to be consistent with licensing data; require labeling information placed on carton tray covers to appear on the outside-face of the tray cover; remove the restriction requiring multiple-dose final containers of veterinary biologics to be packaged in individual cartons; require labeling for bovine virus diarrhea vaccine containing modified live virus to bear a statement warning against use in pregnant animals; reduce the number of copies of each finished final container label, carton label, or enclosure required to be submitted for review and approval; require labeling for autogenous biologics to specify the microorganism(s) and/or antigen(s) they contain; and require labeling for conditionally licensed veterinary biologics to bear a statement concerning efficacy and potency requirements. In addition, this proposed rule would amend the regulations concerning the number of labels or label sketches for experimental products required to be submitted for review and approval, and the recommended storage temperature for veterinary biologics at licensed establishments. These proposed amendments are necessary in order to update and clarify labeling requirements and ensure that information provided in labeling is accurate with regard to the expected performance of the product.

The proposed rule is not expected to have a significant economic impact on most veterinary biologics manufacturers. There are several reasons. First, most manufactures should be able to comply with the rule without having to acquire new labeling equipment or new supplies of labels; their existing equipment for generating labels, as well as their existing inventory of blank labels, should still be usable if the proposal is adopted. This is because the proposed rule primarily affects the type of information required to be shown on the label, not the volume of that information. Since any increase in the volume of information required on labels as a result of the rule should be small, most manufacturers should be able to continue using their existing label equipment and their existing inventory of blank labels. Even manufacturers' existing inventory of preprinted labels (based on the current label requirements) would still likely be usable under the proposal, since it would give manufacturers a total of 3 years to bring all their product labeling into compliance with the rule. It is very likely, therefore, that most or all manufacturers would be able to fully exhaust their existing inventories of preprinted labels before the new label requirements became effective.

Second, the new information that would be required on labels as a result of the rule is basic in nature and should be readily available from manufacturers' existing records; accordingly, manufacturers' cost of obtaining the new information should be negligible, at most.

Third, manufacturers' cost to prepare the new label prototypes (for submission to APHIS) should be minimal, since it is largely an exercise in label editing and formatting.

Finally, any cost increases stemming from the inclusion of the new information on labels should be minimal for most manufacturers.

Benefits of the Proposed Changes: The proposed rule has the potential to benefit consumers of veterinary biologic products ( e.g., farmers, veterinarians, and pet stores) and, ultimately, the animals they treat with those products. This is because it ensures that consumers have complete and up-to-date instructions for the proper use of those products, including vaccination schedules, warnings, and cautions. For animal owners, the monetary benefits are difficult to estimate, because they would depend on several factors that are currently unknown, i.e., the significance, or gravity, of the harm to animals that would be avoided with the rule in effect, and the number, and value, of animals that would avoid harm with the rule in effect. For some animal owners, especially those with large numbers of high value animals, the potential monetary benefits could be substantial.

Costs of the Proposed Changes: For the reasons discussed above, costs to comply with the rule should be minimal for most manufacturers.

The RFA requires agencies to evaluate the potential effects of their proposed and final rules on small entities. Section 603 of the RFA calls for an agency to prepare and make available for public comment an initial regulatory flexibility analysis describing the expected impact of a proposed rule on small entities, unless the head of the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. The following initial regulatory flexibility analysis is presented in order that the public may have the opportunity to offer comments on expected small-entity effects of the proposed rule.

The businesses most directly affected by the proposed rule are the approximately 125 U.S. veterinary biologics manufacturers, including permittees. We believe that all of these entities would be affected, as none is currently in full compliance with the proposed requirements on a voluntary basis. However, for the reasons stated above, the proposed rule is not expected to have a significant economic impact on most veterinary biologics manufacturers.

The size of the affected manufacturers is unknown. However, it is reasonable to assume that most are small in size, under the U.S. Small Business Administration's (SBA) standards (13 CFR 121.201). This assumption is based on composite data for providers of the same and similar services in the U.S. In 2002, there were 296 U.S. establishments in the North American Industry Classification System (NAICS) 325414, a classification comprised of establishments primarily engaged in manufacturing vaccines, toxoids, blood fractions, and culture media of plant or animal origin (except diagnostic). Of the 296 establishments, 285 (or 96 percent) had fewer than 500 employees, the SBA's small entity threshold for establishments in that NAICS category. Similarly, in 2002, there were 236 U.S. establishments in NAICS 325413, a classification comprised of establishments primarily engaged in manufacturing in-vitro diagnostic substances, including biological substances. Of the 236 establishments, 223 (or 95 percent) had fewer than 500 employees, the SBA's small entity threshold for establishments in NAICS 325413. 1

The proposed rule has no mandatory reporting, recordkeeping, or other compliance requirements for biologic manufacturers, other than the requirement that noncompliant labels would need to be revised and submitted to APHIS for review and approval.

APHIS has not identified any relevant Federal rules which may duplicate, overlap, or conflict with this proposed rule.

Finally, the RFA requires agencies to describe any significant alternatives to the proposed rule that accomplish the stated objectives of applicable statutes and that minimize any significant economic impact of the proposed rule on small entities. One alternative would be to leave the regulations unchanged. Leaving the regulations unchanged would be unsatisfactory, because it would perpetuate the current situation, i.e., one that does not provide full information to users of veterinary biologic products. Another alternative would be to require that manufacturers show less, or different, information on their labels. That alternative was rejected because APHIS considers the proposed label information to be of the type, and the minimum, necessary to accomplish the rule's objectives. A third alternative would be to require that manufacturers bring all their product labeling into compliance with the rule immediately, rather than 3 years after the rule becomes effective. This third alternative was unacceptable because it does not minimize the impact on manufacturers, especially those with an inventory of preprinted labels based on the current label requirements.

Notwithstanding the analysis above, APHIS invites public comment on the proposed rule's expected economic impact, including any comment on the impact for small entities.

This program/activity is listed in the category 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 7 CFR part 3015, subpart V.)

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. This rule would not preempt any State or local laws, regulations, or policies where they are necessary to address local disease conditions or eradication programs. However, where safety, efficacy, purity, and potency of biological products are concerned, it is the Agency's intent to occupy the field. This includes, but is not limited to, the regulation of labeling. Under the Act, Congress clearly intended that there be national uniformity in the regulation of these products. There are no administrative proceedings which must be exhausted prior to a judicial challenge to the regulations under this rule.

This proposed rule contains no new information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Accordingly, we propose to amend 9 CFR parts 103, 112, and 114 as follows:

Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal Rulemaking Web site, http://www.regulations.gov. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publicly disclosed.

You can access publicly available documents related to this document using the following methods:

NRC's Public Document Room (PDR): The public may examine and have copied for a fee publicly available documents at the NRC's PDR, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland.

NRC's Agencywide Documents Access and Management System (ADAMS): Publicly available documents created or received at the NRC are available electronically at the NRC's Electronic Reading Room at http://www.nrc.gov/reading-rm/adams.html. From this page, the public can gain entry into ADAMS, which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC's PDR reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to PDR.Resource@nrc.gov.

Federal Rulemaking Web site: Public comments and supporting materials related to this proposed rule can be found at http://www.regulations.gov by searching on Docket ID NRC-2011-0002.

For additional information, see the Direct Final Rule published in the Rules and Regulations section of this Federal Register.

On May 6 and 7, 2010, respectively, a direct final rule (75 FR 24786) and companion proposed rule (75 FR 25120) were published in the Federal Register to revise the cask system listing for the TN NUHOMS® HD System by adding Amendment No. 1 to the list of approved spent fuel storage casks in Title 10 of the Code of Federal Regulations (10 CFR) 72.214. After the rules were published, the applicant identified that a certain TS for Boral characterization (TS 4.3.1, “Neutron Absorber Tests”) was not written precisely and in a manner that could be readily and demonstrably implemented. On July 16, 2010, the NRC withdrew the direct final rule (75 FR 41369) and the companion proposed rule (75 FR 41404).The applicant submitted revised language for TS 4.3.1 (and Final Safety Analysis Report (FSAR) sections incorporated into the TS by reference) on July 26 and August 24, 2010, which NRC staff reviewed and found to be acceptable. This proposed rule includes the original Amendment No. 1 changes and the revised TS 4.3.1 and FSAR sections incorporated into the TS by reference.

This rule is limited to the changes contained in Amendment No. 1 to CoC No. 1030 and does not include other aspects of the NUHOMS® HD System design. Because NRC considers this action noncontroversial and routine, the NRC is publishing this proposed rule concurrently as a direct final rule in the Rules and Regulations section of this Federal Register . Adequate protection of public health and safety continues to be ensured. The direct final rule will become effective on March 29, 2011. However, if the NRC receives significant adverse comments on the direct final rule by February 14, 2011, then the NRC will publish a document that withdraws the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to the proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action in the event the direct final rule is withdrawn.

A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1) The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a) The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c) The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2) The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3) The comment causes the NRC staff to make a change (other than editorial) to the rule, CoC, or TS.

For additional procedural information and the regulatory analysis, see the direct final rule published in the Rules and Regulations section of this Federal Register .

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; the Nuclear Waste Policy Act of 1982, as amended, and 5 U.S.C. 553; the NRC is proposing to adopt the following amendments to 10 CFR Part 72.

Comments Invited

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2010-1310; Directorate Identifier 2010-NM-067-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The Agência Nacional de Aviação Civil (ANAC), which is the aviation authority for Brazil, has issued Brazilian Airworthiness Directive 2009-11-01, dated November 30, 2009, applicable to Model ERJ 170 airplanes; and Airworthiness Directive 2009-08-02, dated August 18, 2009, applicable to Model ERJ 190 airplanes; (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products.

MCAI 2009-11-01 states:

MCAI 2009-08-02 states:

The required actions include modifying the escape slides of the forward passenger and service doors, and doing boroscope inspections for damage of the aspirator body and inlet cross valve. Corrective actions include replacing the aspirator body. You may obtain further information by examining the MCAI in the AD docket.

Goodrich Interiors has issued Service Bulletin 4A4030-25A379, dated August 10, 2009, for Model ERJ 170 airplanes; and Service Bulletin 104003-25A380, Revision 2, dated July 7, 2009, for Model ERJ 190 airplanes. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a Note within the proposed AD.

Based on the service information, we estimate that this proposed AD would affect about 236 products of U.S. registry. We also estimate that it would take about 12 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $240,720, or $1,020 per product.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

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

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2010-1308; Directorate Identifier 2009-NM-069-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

On June 14, 2005, we issued AD 2005-13-19, Amendment 39-14156 (70 FR 37022, June 28, 2005). That AD required actions intended to address an unsafe condition on the products listed above.

Since we issued AD 2005-13-19, a further report of cracking has been received at an interval shorter than the repetitive inspection interval required by AD 2005-13-19. The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA Airworthiness Directive 2009-0070R1, dated July 2, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

BAE SYSTEMS (OPERATIONS) LIMITED has issued Inspection Service Bulletin ISB.53-167, Revision 4, dated June 10, 2010. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Based on the service information, we estimate that this proposed AD would affect about 1 product of U.S. registry.

The actions that are required by AD 2005-13-19 and retained in this proposed AD take about 40 work-hours per product, at an average labor rate of $85 per work hour. Based on these figures, the estimated cost of the currently required actions is $3,400 per product.

We estimate that it would take about 32 work-hours per product to comply with the new basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $2,720, or $2,720 per product.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

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

• We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2010-1309; Directorate Identifier 2010-NM-060-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD based on those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the aviation authority for the Member States of the European Community, has issued EASA Airworthiness Directive 2010-0021, dated February 9, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

Airbus has issued All Operators Telexes (AOTs) A330-55A3040 and A340-55A4036, both Revision 02, both dated September 30, 2009. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.

Currently, there are no affected airplanes on the U.S. Register. However, if an affected airplane is imported and placed on the U.S. Register in the future, the required actions would take about 21 work hours, at an average labor rate of $85 per work hour. Based on these figures, we estimate the cost of this AD to be $1,785 per airplane.

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

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

In a November 24, 2010, Notice of Intent published in the Federal Register (75 FR 71635), DEA announced its intention to temporarily place five synthetic cannabinoids into schedule I of the Controlled Substances Act (CSA) pursuant to 21 U.S.C. 811(h). Due to an administrative error, DEA included in that notice a paragraph addressing the Regulatory Flexibility Act (RFA) in the “Regulatory Certifications” section of that document. The provisions of the RFA have no application to temporary scheduling orders issued under 21 U.S.C. 811(h) or to notices of intention to issue such orders. Accordingly, DEA certification under the RFA is not legally required for this temporary scheduling order. Therefore, I hereby order that this paragraph (the first full paragraph in the right column on page 71637), as well as the “Regulatory Flexibility Act” heading that precedes it, be stricken.

DEA also inadvertently included in its Notice of Intent a certification relating to the Congressional Review Act. The Congressional Review Act only applies to “final” rules. Accordingly, inclusion of the paragraph relating to the Congressional Review Act in the Notice of Intent was premature. Therefore, I hereby order that this paragraph (the fifth paragraph in the right column on page 71637 and continued on the top of page 71638), as well as the “Congressional Review Act” heading that precedes it, also be stricken.

Currently, Reserve Component members who separate from active duty after serving for more than 30 days in support of a contingency operation are entitled to dental care under the transitional assistance medical program in the same manner as a dependent. This consists of only space-available dental care in a military dental treatment facility and is very limited.

This proposed rule amends the transitional health care dental benefit for Reserve Component members who were on active duty for more than 30 days in support of a contingency operation by providing those members' dental care the same as that for a member of the uniformed services on active duty for more than 30 days. This enhanced benefit does not apply to members' dependents.

As mentioned, the transitional health care dental benefits for Reserve Component members include space available care in military dental treatment facilities. Additionally, Reserve Component members are eligible for the TRICARE Dental Program (TDP). The TDP provides comprehensive dental care insurance and requires premium and cost-share payments but includes an annual maximum per enrollee per contract year for non-orthodontic services. This means that the total payments for covered dental services (except orthodontic services) for each enrolled member will not exceed the annual maximum amount in any contract year. The Government subsidizes 60 percent of the premium cost for enrolled Reserve Component members. If activated for more than 30 days in support of a contingency operation, a TDP enrolled Reserve Component member is automatically disenrolled from the TDP and automatically re-enrolled upon deactivation.

Under the proposed rule, a TDP enrolled Reserve Component member activated for more than 30 days is still automatically disenrolled from the TDP; however, the Reserve Component member will not be automatically re-enrolled upon deactivation because the member will be entitled to the same dental benefits as an active duty member. The Reserve Component member will be TDP eligible and automatically re-enrolled in the TDP after the Transitional Health Care period is completed.

Reserve Component family members are also eligible for the TRICARE Dental Program (TDP). These family members pay 100% of the premiums while their sponsor is in Reserve status. If their sponsor is activated for more than 30 days, the TDP enrolled Reserve Component family members obtain the same benefits as any other TDP enrolled active duty family members with the Government subsidizing 60 percent of the premium cost for enrolled active duty family members. This change in status and subsidy occurs automatically. Upon the sponsor's deactivation, the family members automatically revert to Reserve Component family member TDP status and pay 100% of the TDP premium cost. With the proposed rule, there is no change to status or eligibility for family members.

Executive Order 12866 requires that a comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act (RFA) requires that each Federal agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This rule is not an economically significant regulatory action and will not have a significant impact on a substantial number of small entities for purposes of the RFA. Thus this proposed rule is not subject to any of these requirements. This proposed rule would amend the Code of Federal Regulations to conform to the new statutory authority. Public comments are invited. All comments will be carefully considered. A discussion of the major issues received by public comments will be included with the issuance of the final rule.

This rule does not contain unfunded mandates. It does not contain a Federal mandate that may result in the expenditure by State, local and tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

This rule will not impose additional information collection requirements on the public under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3511).

We have examined the impact(s) of the proposed rule under Executive Order 13132 and it does not have policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, therefore, consultation with State and local officials is not required.

Accordingly, 32 CFR Part 199 is proposed to be amended as follows:

The TRICARE benefit was directed by Congress in section 1097 of the National Defense Authorization Act for Fiscal Year 1995. For further information on TRICARE, the reader may refer to the final rule regarding TRICARE published in the Federal Register on October 5, 1995.

Managed care support contractors are required to establish adequate networks throughout regions to complement military treatment facilities and support TRICARE Prime and Extra. However, there are many active duty members of the uniformed Services and their families who are required by the member's duty assignment to live in certain more remote areas where there are insufficient numbers or types of specialty or subspecialty providers to provide care within normal drive-time access standards notwithstanding the due diligence of the contractors in developing the network around the military treatment facilities or their diligence in finding network providers for those members or families enrolled in TRICARE Prime Remote. Under such exceptional circumstances as identified under procedures and guidelines issued by the Director, TRICARE Management Activity, reasonable travel expenses to obtained specialty care for which the enrollee has been referred may be reimbursed. The specific location or identity of these military treatment facilities and the specific TRICARE Prime Remote locations and the types of specialists or sub-specialists shall be determined in accordance with guidelines issued by the Assistant Secretary of Defense for Health Affairs. The guidelines shall include identity of the specific military treatment facility or TRICARE Prime Remote area, validation by either, or both, the facility commander and/or the Director of the TRICARE Regional Office that the specialty care provider or category of specialty care provider required to provide care to the active duty member and their dependents, are not available within a 60 minute drive time, but are available within 100 miles of the military treatment facility or primary care manager's office. The Director of the TRICARE Regional Office shall also verify that the Managed Care Support Contractor has used due diligence in attempting to enroll the needed specialists who do meet the drive time specialty care access standards, into the network. The Director, TRICARE Management Activity shall establish and make available a list of military treatment facilities and category of specialty providers for which these reasonable travel expenses shall be allowed. For members, and families, enrolled in TPR the Director shall ensure that adequate coordination of care and travel benefits is provided to those qualifying members and their families.

Executive Order 12866 requires that a comprehensive regulatory impact analysis be performed on any economically significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. The Regulatory Flexibility Act (RFA) requires that each Federal Agency prepare, and make available for public comment, a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This proposed rule is not a significant regulatory action and will not have a significant impact on a substantial number of small entities for purposes of the RFA. Thus this proposed rule is not subject to any of these requirements.

This rule will not impose additional information collection requirements on the public.

We have examined the impacts of the rule under Executive Order 13132 and it does not have policies that have federalism implications that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, therefore, consultation with State and local officials is not required.

This rule does not contain unfunded mandates. It does not contain a Federal mandate that may result in the expenditure by State, local and Tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year.

Accordingly, 32 CFR part 199 is proposed to be amended as follows:

I. Hospice

This proposed rule revises the regulation for hospice periods of care. The Defense Authorization Act for FY 1992-1993, Public Law 102-190, directed TRICARE to provide hospice care in the manner and under the conditions provided in section 1861(dd) of the Social Security Act (42 U.S.C. 1395x(dd)). Congress' intent was for TRICARE to establish a benefit in the same manner as Medicare. TRICARE originally had the same periods of hospice care used by Medicare; however, over time the Medicare benefit changed, but TRICARE's regulation has not. The TRICARE regulation currently provides for an initial period of 90 days, a subsequent period of 90 days, a second subsequent period of 30 days, and a final period of unlimited duration. Rather than maintaining this level of specificity in the regulation and to ensure that TRICARE and Medicare's benefit periods are equal, we are revising the regulation to state that the distinct periods of care available under the hospice benefit shall be the same as those offered under Medicare's hospice program. Currently under Medicare, patients are entitled to two 90-day election periods, followed by an unlimited number of 60-day periods. The level of specific benefits shall be included in the TRICARE Reimbursement Manual, and may be accessed at http://www.tricare.mil.

The current regulatory language references specific reimbursement percentages for assistant-at-surgery reimbursement. Rather than including these specific percentage amounts, which would require a regulatory change any time the percentage amounts change, we are making a general statement referring to the current percentages used by Medicare. Our authority for this is 10 U.S.C. 1079(h) which states: Except as provided in paragraphs (2) and (3), payment for a charge for services by an individual health care professional (or other noninstitutional health care provider) for which a claim is submitted under a plan contracted for under subsection (a) shall be equal to an amount determined to be appropriate, to the extent practicable, in accordance with the same reimbursement rules as apply to payments for similar services under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq. ). The Secretary of Defense shall determine the appropriate payment amount under this paragraph in consultation with the other administering Secretaries. The specific percentages are more appropriately included in the TRICARE Reimbursement Manual, and may be accessed at http://www.tricare.mil.

10 U.S.C. 1079(j)(2) provides that the amount to be paid to a provider of services for services provided under a plan covered by this section shall be determined under joint regulations to be prescribed by the administering Secretaries which provide that the amount of such payments shall be determined to the extent practicable in accordance with the same reimbursement rules as apply to payments to providers of services of the same type under title XVIII of the Social Security Act (42 U.S.C. 1395 et seq. ).

In accordance with the above statute, the TRICARE/CHAMPUS DRG-based payment system transitioned to adopting the Medicare Severity-DRG based payment system on October 1, 2008. When TRICARE transitioned to the severity-based system, it was necessary to renumber the existing DRGs, and to assign different narrative descriptions to the DRG numbers. As a result, the existing regulatory reference to specific DRG numbers and descriptions became obsolete, so we are removing the numeric references in the regulation and utilizing only the descriptive terminology.

Section 801 of title 5, United States Code, and Executive Order (E.O.) 12866 require certain regulatory assessments and procedures for any major rule or significant regulatory action, defined as one that would result in an annual effect of $100 million or more on the national economy or which would have other substantial impacts. It has been certified that this rule is not economically significant. It has been reviewed by the Office of Management and Budget as required under the provisions of E.O. 12866.

Section 202 of Public Law 104-4, “Unfunded Mandates Reform Act,” requires that an analysis be performed to determine whether any Federal mandate may result in the expenditure by State, local and Tribal governments, in the aggregate, or by the private sector of $100 million in any one year. It has been certified that this proposed rule does not contain a Federal mandate that may result in the expenditure by State, local and Tribal governments, in aggregate, or by the private sector, of $100 million or more in any one year, and thus this proposed rule is not subject to this requirement.

Public Law 96-354, “Regulatory Flexibility Act” (RFA) (5 U.S.C. 601), requires that each Federal agency prepare a regulatory flexibility analysis when the agency issues a regulation which would have a significant impact on a substantial number of small entities. This proposed rule is not an economically significant regulatory action, and it has been certified that it will not have a significant impact on a substantial number of small entities. Therefore, this proposed rule is not subject to the requirements of the RFA.

This rule does not contain a “collection of information” requirement, and will not impose additional information collection requirements on the public under Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35).

E.O. 13132, “Federalism,” requires that an impact analysis be performed to determine whether the rule has federalism implications that would have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. It has been certified that this proposed rule does not have federalism implications, as set forth in E.O. 13132.

Accordingly, 32 CFR Part 199 is proposed to be amended as follows:

In the Final Rules section of this Federal Register , EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If we do not receive any adverse comments in response to this rule, we do not contemplate taking any further action. If EPA receives adverse comments, we will withdraw the direct final rule, and will address all public comments in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment. For additional information, see the direct final rule, which is located in the Final Rules section of this Federal Register .

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

The proposed Sentinel Energy Project is designed to be a nominally rated 850 megawatt electrical generating facility covering approximately 37 acres within Riverside County, adjacent to Palm Springs, California. The Sentinel Energy Project will emit air pollutants from eight General Electric LMS100 combustion turbine generators equipped with oxidation catalyst and selective catalytic reduction equipment, eight single cell mechanical draft cooling towers, and a 240 brake horsepower Tier III diesel emergency fire pump engine.

The California Energy Commission (CEC) approved the application for certification for Sentinel on December 1, 2010. The District issued a Final Determination of Compliance (FDOC) and an Addendum to the FDOC, known as Appendix N, on March 2, 2010. Appendix N to the FDOC has evolved into the AB 1318 Tracking System submitted as part of this SIP revision. The CEC certification and the District's FDOC require the Sentinel Energy Project to install and operate stringent emissions controls to reduce emissions of NO X , VOC, CO and PM 10 to the lowest achievable emissions rates.

Pursuant to section 173 of the CAA, new major stationary sources are required to provide offsetting emission reductions for any non-attainment pollutants that continue to be emitted after operation of the most stringent emissions controls, if those levels exceed certain thresholds. 42 U.S.C. 7503(a)(1)(A). The District implements these requirements through its NSR program in Regulation XIII, which EPA approved into the SIP in 1996 as meeting the requirements for CAA Section 110, Part D. 61 FR 64291.

The District estimated the amount of offsetting emission reductions that Sentinel must provide to comply with District Rule 1303 and CAA § 173 for all non-attainment pollutants. For all pollutants other than PM 10 and SO X , Sentinel has purchased Emission Reduction Credits (ERCs) on the open market. Those ERCs comply with Rule 1309.

For PM 10 and SO X emissions, the California Legislature enacted California Assembly Bill (AB) 1318, which went into effect on January 1, 2010. AB 1318 requires the District, upon making a specified finding, to transfer SO X and PM 10 emission offsets from its internal bank to eligible electric generating facilities. The District determined that the Sentinel Energy Project met all of the requirements of an eligible electric generating facility and made the required finding.

AB 1318 also establishes requirements for the District's implementation of transferring the offsetting emission reductions from its internal bank to an eligible electric generating facility and for tracking the transfer of offsetting emissions reductions. The District completed those requirements as documented in Appendix N to the FDOC, which has evolved into the AB 1318 Tracking System for this SIP revision. The offsetting emission reductions transferred to the AB 1318 Tracking System from the District's internal bank were created by permitted equipment that permanently ceased or reduced operations in District. The District examined each of these offsetting emission reductions and determined that they met the “integrity criteria” established in CAA § 173(c). Specifically, the District determined that the offsetting emission reductions were real, permanent, quantifiable, enforceable and surplus. The District then transferred those specific PM 10 and SO X offsetting emission reductions out of its internal bank and into the AB 1318 Tracking System. These offsetting emission reductions are no longer available for use in any other action.

The amounts of offsetting emission reductions the District transferred from its internal bank to the AB 1318 Tracking System are based on estimated actual PM 10 and SO X emissions reported to the District according to its Annual Emissions Reporting Program. For each source of offsetting emission reductions from a permanent shutdown of equipment, the District has inactivated that source's permit. For each offsetting emission reduction created by a source reducing emissions, the District has revised the source's federally enforceable permit to ensure the reduction is permanent. The complete list of PM 10 and SO X offsetting emission reductions is provided in the AB 1318 Tracking System which is attached to EPA's Technical Support Document (TSD). Documentation for each of these offsetting emission reductions is included in the docket for this proposal.

The District adopted the CPV Sentinel Energy Project AB 1318 Tracking System on July 9, 2010. The California Air Resources Board (CARB) submitted the CPV Sentinel Energy Project AB 1318 Tracking System to EPA as a source specific SIP revision on September 10, 2010. EPA issued a completeness letter on October 27, 2010, finding that the submittal had met the completeness criteria in 40 CFR Part 51 Appendix V.

The package that the District, through CARB, submitted to EPA consists of text to be included as a revision to the District's portion of the California SIP, and the Sentinel Energy Project AB 1318 Tracking System created to implement this new SIP provision. The District's SIP text incorporates the Sentinel Energy Project AB 1318 Tracking System by reference. The AB 1318 Tracking System includes specific offsetting emission reductions that were identified from reductions of SO X and PM 10 occurring between 1999 and 2008 from permitted equipment that has either permanently ceased operations in the District or became subject to federally enforceable conditions that reduced actual emissions. The District has not issued any Rule 1309 ERCs for these specific emissions reductions and has inactivated the permits for the equipment that has been shut down. These SO X and PM 10 offsetting emission reductions were transferred out of the District's internal bank and into the AB 1318 Tracking System. These reductions have not been used by any other source and cannot be used for any other source in the future if they are used to construct the CPV Sentinel Energy Project. A copy of the AB 1318 Tracking System for CPV Sentinel is included as an attachment to the TSD for this action.

The text of the proposed source-specific SIP revision, in relevant part, is:

The SIP revision is intended to provide a federally approved and enforceable mechanism for the District to transfer PM 10 and SO X offsetting emissions reductions from the District's internal bank to the Sentinel Energy Project and to track those emissions credits through the AB 1318 Tracking System.

The South Coast Air Basin is an extreme non-attainment area for ozone and a serious non-attainment area for PM 10 . Sulfur oxide emissions are PM 10 precursors and are therefore also treated as a PM 10 non-attainment pollutant. As required by CAA § 110(a)(2)(C), SIPs are required to include provisions to comply with CAA Part D for non-attainment pollutants. Among the Part D requirements, § 173(a)(1)(A) requires offsetting emission reductions for new and modified major stationary sources. Section 173(c) requires the offsetting emission reductions to be real, quantifiable, surplus, permanent, and enforceable.

The District's NSR permitting program is contained in District Regulation XIII, which was approved into the South Coast portion of the California SIP on December 4, 1996, for purposes of complying with the CAA Part D. (61 FR 64291). District Rule 1303(b)(2) requires the District to deny a permit to construct a new source or modify an existing source unless it is exempt from offset requirements pursuant to Rule 1304, emissions increases are offset by ERCs approved pursuant to Rule 1309, or the source obtains allocations from the District's Priority Reserve accounts in accordance with the provisions of Rule 1309.1. For PM 10 and SO X emissions, Sentinel is not exempt pursuant to Rule 1304 and does not qualify for allocations from the Priority Reserve. 1

1. As recommended in the National Broadband Plan, this Notice of Inquiry (NOI) initiates a comprehensive proceeding to address how Next Generation 911 (NG911) can enable the public to obtain emergency assistance by means of advanced communications technologies beyond traditional voice-centric devices. In the telecommunications industry overall, competitive forces and technological innovation have ushered in an era of advanced Internet-Protocol (IP)-based devices and applications that have vastly enhanced the ability of the public to communicate and send and receive information. At the same time, our legacy circuit-switched 911 system is unable to accommodate the capabilities embedded in many of these advanced technologies, such as the ability to transmit and receive photos, text messages, and video. Accordingly, in this proceeding, we seek to gain a better understanding of how the gap between the capabilities of modern networks and devices and today's 911 system can be bridged. We also seek comment on how to further the transition to IP-based communications capabilities for emergency communications and NG911.

2. Since AT&T first made the digits “911” available nationally in 1968 for wireline access to emergency services, the American public increasingly has come to depend on the service. Today, the National Emergency Number Association (NENA) estimates that some form of 911 service is available to 99 percent of the population in 96 percent of the counties in the United States, and 240 million calls are made to 911 in the United States each year. “911” is as well known as any popular brand, and is what we routinely teach to children as the way to summon help from police, fire, and ambulance services. In more recent times, 911 has become increasingly important for homeland security, as the means for ordinary citizens—in some ways the true “first responders”—to report suspicious activity or summon emergency assistance for themselves and others in times of natural or man-made disasters. It should therefore come as no surprise that the American public has developed clear expectations with respect to the availability of 911 emergency services via certain classes of communications devices.

3. The availability of this critical service is due largely to the dedicated efforts of State, local, and Tribal authorities and telecommunications carriers, who have used the 911 abbreviated dialing code to provide access to increasingly advanced and effective emergency service capabilities. Indeed, absent appropriate action by, and funding for, states, Tribes, and local jurisdictions, there can be no effective 911 service.

4. At the same time, new voice communications technologies have posed technical and operational challenges to the 911 system, necessitating the adoption of a uniform national approach to preserve the quality and reliability of 911 services for such communications technologies. This was first recognized following the introduction of commercial mobile radio services (CMRS) in the United States, when the Commission in 1996 established rules requiring CMRS carriers to implement basic 911 and Enhanced 911 (E911) services.

5. In 1999, Congress continued this recognition when it enacted the Wireless Communications and Public Safety Act (911 Act) to promote and enhance public safety through the use of wireless communications services. The 911 Act directed the Commission to designate 911 as the universal emergency assistance number for wireless and wireline calls, and to establish a transition period for areas of the country where 911 was not yet available. In 2000, the Commission adopted an order which established 911 as the universal emergency telephone number in the United States. In 2003, the Commission revised “the scope of [its] enhanced 911 rules to clarify which technologies and services will be required to be capable of transmitting enhanced 911 information.” In adopting rules tailored to specific services, the Commission clarified, inter alia, the following matters: (1) Telematics service providers offering interconnected CMRS voice calling service may have an E911 service requirement and need to coordinate with the underlying wireless carriers, so that, regardless of the legal relationship between them, E911 requirements can be met; and (2) resold and prepaid mobile wireless service providers must meet 911 rules to the extent the underlying licensee has deployed the necessary technology for E911 service. The Commission declined, however, to impose E911 requirements on: (1) Telematics-only services providers, reserving the right to revisit E911 obligations in the future, (2) manufacturers of disposable phones or personal data assistants (PDAs) that contain a voice service component, and (3) multi-line telephone systems, except for the Commission's monitoring of states' progress on implementing E911 for those systems.

6. The next significant step in the evolution of 911 followed the introduction of Voice over Internet Protocol (VoIP) services in the United States. In this regard, in 2005, the Commission established rules requiring interconnected VoIP service providers to supply E911 capabilities to their customers as a standard feature from wherever the customer is using the service.

7. While the Commission and the 911 industry acted to enable 911 service availability for wireless and VoIP providers, today's 911 system remains reliant on increasingly antiquated analog or digital circuit-switched facilities. It is thus not capable of supporting certain functionalities made possible by a transition to broadband IP-based communications technologies—functionalities that have become commonplace in other communications systems. At the same time, the introduction of these new technologies has created the potential for development of and transition to NG911 to take advantage of the enhanced capabilities of IP-based devices and networks.

8. In the last few years, there have been several important efforts to address the need for a transition to a NG911 network. In the New and Emerging Technologies 911 Improvement Act of 2008, Congress tasked the National E9-1-1 Implementation Coordination Office (ICO) to develop “a national plan for migrating to a national [Internet Protocol] IP-enabled emergency network capable of receiving and responding to all citizen-activated emergency communications and improving information sharing among all emergency response entities.” The ICO, managed jointly by the Department of Commerce's National Telecommunications and Information Administration (NTIA) and the Department of Transportation's National Highway Traffic Safety Administration (NHTSA), released its migration plan in September 2009. In March 2010, NENA released a handbook to serve as a guide for public safety personnel and government officials responsible for ensuring that Federal, State, and local 911 laws and regulations effectively enable the implementation of NG911 systems. Specifically, the NENA Handbook provides an overview of key policy, regulatory, and legislative issues that need to be considered to enable the transition to NG911. The NENA Handbook states that “it is critical that State regulatory bodies and the FCC take timely and carefully scrutinized action to analyze and update existing 9-1-1, PSTN, and IP rules and regulations to ensure they optimize 9-1-1 governing authority choices for E9-1-1 and NG9-1-1 and foster competition by establishing a competitively neutral marketplace.”

9. On March 16, 2010, the Commission delivered the National Broadband Plan to Congress, which included several recommendations related to NG911. Specifically, the Plan noted that the Commission was already considering changes to its E911 location accuracy requirements and recommended that the Commission expand that proceeding to explore how NG911 may affect location accuracy and provision of automated location information. The Plan further recommended that the Commission initiate a new proceeding “to address how NG911 can accommodate communications technologies, networks and architectures beyond traditional voice-centric devices,” and to “explore how public expectations may evolve in terms of the communications platforms the public would rely upon to request emergency services.”

10. In September 2010, addressing the National Broadband Plan recommendation with respect to location accuracy, we adopted a Further Notice of Proposed Rulemaking and Notice of Inquiry in our E911 Location Accuracy proceeding, in which we sought comment on a number of issues pertaining to the Commission's location accuracy rules, including the impact of NG911 deployments on location accuracy and Automatic Location Identification (ALI). The FNPRM and NOI was published in the Federal Register at 75 FR 67321, November 2, 2010. In the Location Accuracy FNPRM/NOI, we limited the scope of our NG911 inquiry to location issues in the provision of voice-based services. In this Notice of Inquiry, we initiate the broader proceeding recommended in the National Broadband Plan concerning the migration to NG911.

11. Most recently, on October 8, 2010, the Twenty-First Century Communications and Video Accessibility Act of 2010 (Twenty-First Century Act) was signed into law. The Twenty-First Century Act directs the Chairman of the Commission to establish an advisory committee, to be known as the Emergency Access Advisory Committee (EAAC), for the purpose of achieving equal access to emergency services by individuals with disabilities as part of our nation's migration to NG911. The Twenty-First Century Act also directs the EAAC to conduct a national survey with people with disabilities and make recommendations on the most effective and efficient technologies and methods to enable NG911 access. The EAAC will be composed generally of State and local government representatives responsible for emergency management and emergency responder representatives, national organizations representing people with disabilities and senior citizens, communications equipment manufacturers, service providers, and subject matter experts.

12. In order to understand the opportunities and challenges involved with deploying an NG911 system across the country, it is instructive to first briefly review how, as a technical matter, the current 911 system operates for wireline, wireless and interconnected VoIP 911 calls, and how NG911 will differ from legacy 911 in its applications and network architecture. For brevity, the discussion simplifies some of the technical details of both legacy and NG911 systems.

13. In the United States, legacy 911 service generally falls into two categories—basic and enhanced. Basic 911 service transmits 911 calls from the service provider's switch to a single geographically appropriate Public Safety Answering Point (PSAP) or public safety agency, usually over dedicated emergency trunks. Basic 911 networks are not capable of taking into account the caller's location, but simply forward all 911 calls from a particular PSTN switch to the appropriate PSAP or public safety agency. E911 service expands basic 911 service by not only delivering 911 calls to the appropriate PSAP or agency, but also providing the call taker with the caller's call back number, referred to as Automatic Numbering Information (ANI), and location information—a capability referred to as Automatic Location Identification (ALI). Most areas of the country have now implemented E911 service.

14. Wireline E911. In wireline E911, PSAPs are connected to telephone switches by dedicated trunk lines. Wireline E911 networks generally have been implemented, operated, and maintained by a subset of incumbent LECs, and are largely paid for by PSAPs through tariffs. Network implementation varies from carrier to carrier and jurisdiction to jurisdiction, but usually is based on traditional circuit-switched architecture and implemented with legacy components that place significant limitations on the functions that can be performed over the network. Typically, a wireline E911 network utilizes a selective router, which receives 911 calls from competitive and incumbent LEC central offices over dedicated trunks. The selective router then queries an incumbent LEC-maintained selective router database (SRDB) to determine which PSAP serves the caller's geographic area. The selective router will then forward the call, along with the caller's phone number (i.e., ANI) to the PSAP that has been designated to serve the caller's area. The PSAP then forwards the caller's ANI to an incumbent LEC-maintained Automatic Location Identification database (ALI database). The ALI database returns to the PSAP the caller's physical address (that has previously been verified by comparison to the MSAG). Wireline E911 networks also include a Database Management System (DBMS), which provides a method for competitive and incumbent LECs to enter customer data into both the SRDB and the ALI Database.

15. Wireless E911. Under the Commission's wireless E911 rules, wireless carriers are obligated to provide the telephone number of the originator of a 911 call (i.e., ANI) and information regarding the caller's location ( i.e., ALI) to any PSAP that has requested that such information be delivered with 911 calls. As explained in the VoIP 911 Order and VoIP 911 NPRM, the mobile nature of wireless technology and other IP-enabled services presents significant obstacles to making E911 effective—in particular the provision to PSAPs of accurate ALI. Specifically, the mobility of wireless service renders the use of permanent street addresses as a location indicator useless, and often requires the provision of real-time location updates to the PSAP. In addition, the caller's phone number ( i.e., the ANI information) may not be usable by the selective router for PSAP routing purposes within the specific geographic region in which the mobile 911 call was placed. To overcome this mobility problem, wireless carriers have developed various techniques to provision ANI and ALI to the PSAP that involve enhancements or “add-ons” to existing Wireline E911 networks.

16. Interconnected VoIP E911. Under the Commission's rules, interconnected VoIP providers must provide E911 service to their customers. As with wireless service, the mobile nature of interconnected VoIP service presents challenges in making E911 effective. Since an emergency call may be placed from outside the caller's home area code, completing the call may require the use of “pseudo-ANI” (p-ANI). The most difficult challenge, however, is the inability of the VoIP device or service provider to determine the current geographic location of the caller. As a result, the Commission requires interconnected VoIP providers to obtain location information, called “Registered Location,” from their subscribers, which is either entered manually or based on the subscriber's billing record. Under this approach, if a VoIP subscriber does not update his or her location, the subscriber's 911 call may be routed to the wrong PSAP, which may delay the emergency response.

17. Beyond the basic functionality above, the Commission imposes additional obligations on interconnected VoIP service providers. Under the Commission's rules, interconnected VoIP providers must forward all 911 calls made over their interconnected VoIP service, as well as a call back number and the caller's Registered Location for each call, to the appropriate PSAP. These calls must be routed through the use of ANI and, if necessary, and similar to wireless carriers, p-ANI, via the dedicated wireline E911 network, and the caller's Registered Location must be available from or through the ALI Database. Additionally, interconnected VoIP providers must comply with several customer notification requirements that include apprising their subscribers of any limitations in providing E911 service.

18. Next Generation 911 relies on IP-based architecture rather than the PSTN-based architecture of legacy 911 to provide an expanded array of emergency communications services that encompasses both the core functionalities of legacy E911 and additional functionalities that take advantage of the enhanced capabilities of IP-based devices and networks. NENA defines NG911 as “a system comprised of hardware, software, data and operational policies and procedures * * *, to: Provide standardized interfaces from call and message services; process all types of emergency calls including non-voice (multi-media) messages; acquire and integrate additional data useful to call routing and handling; deliver the calls/messages and data to the appropriate PSAPs and other appropriate emergency entities; support data and communications needs for coordinated incident response and management provide a secure environment for emergency communications.”

19. In an NG911 environment, IP-based technologies and applications are used to provide call identification, location determination, call routing, and call signaling for emergency calls. Call identification determines that a call (which may be a voice call or some other form of communication) is indeed an emergency call, mapping a user-visible identifier (such as the digits 911 or 112) to a network-standard uniform emergency call identifier, such as an emergency service Uniform Resource Name (URN). Location determination provides the civic or geospatial location of the caller to the initiating call router, which will then use the emergency call identifier and the location information, along with other information, to route the call to the nearest IP-enabled PSAP.

20. The NG911 architecture also redefines the functions and capabilities of PSAPs, who receive and process emergency calls by means of Emergency Services IP Networks (ESInets). An ESInet is an IP-based network used by the PSAP and other agencies that may be involved in responding to an emergency. Emergency calls can be delivered to an ESInet from several types of originating networks, including both NG911 networks and legacy 911 networks. The ESInet, in turn, completes the call to the appropriate PSAP. The call signaling uses the same standard protocols as non-emergency calls, but user devices may use other protocols via gateways.

21. The nature of NG911 technology and architecture leads to certain key differences when compared to legacy 911, as detailed in the paragraphs below:

• NG911 networks can be accessed by a wide variety of end users and devices, many of which will have identifiers other than telephone numbers.

• NG911 networks are capable of supporting multiple voice and non-voice services, whereas legacy 911 supports voice only.

• In NG911, the difference between mobile, nomadic, and fixed services is blurred, because a single device may operate in mobile, nomadic, and fixed configurations at different times and locations.

• In NG911, network access and communications service may be provided by separate entities rather than the same entity.

• NG911 network services can be provided by servers largely independent of location.

22. As pointed out by the Internet Engineering Task Force, Emergency Context Resolution with Internet Technologies (IETF-ECRIT) working group, the use of the Internet rather than circuit-switched networks changes the requirements and operating conditions of IP-based emergency calling. For example, in an NG911 call scenario, the caller's provider of Internet access services may not be the same entity that provides voice calling services, i.e., that routes calls and bridges them to the PSTN when needed. Moreover, the voice service provider may be located far away from the caller, possibly in another country, while the Internet access provider remains, by physical necessity, local to the caller. The voice service provider may also not be a traditional telecommunications provider, particularly as the need to interconnect with the PSTN diminishes.

23. Unlike communications systems that interconnect with the PSTN, IP-based communication systems are media-neutral, i.e., they can transport any digital information, regardless of content, and are not limited to voice or voice-band data (TTY). As a result, a wide variety of voice and non-voice services can share the same Internet infrastructure. Moreover, while wireless or wireline E911 network users need no special capabilities to dial 911, current standards-based architectures for NG911 envision a more active role for end-user devices and systems in identifying emergency calls and acquiring the caller's location information. This makes it easier for NG911 networks to add media beyond voice, although it also creates additional challenges such as security.

24. NG911 will also require a new and more multi-faceted approach to caller identification. In legacy E911 networks, all callers have telephone numbers as identifiers, most of which are domestic (+1) numbers. Initially, most users of IP-based systems ( e.g. , interconnected VoIP) will also have telephone numbers, but an increasing percentage of these users are likely to have international rather than domestic numbers. Moreover, in the longer term, as IP-based networks support an increasing diversity of non-interconnected and non-voice services, potential NG911 end users and devices are less likely to have any type of telephone number and more likely to have identifiers such as email addresses, Session Initiation Protocol (SIP) URLs or service-specific “handles.”

25. In contrast to the device-specific connection protocols in legacy 911 networks for wireline, wireless, and interconnected VoIP phones, NG911 will need to provide IP-enabled devices with multiple means of accessing the NG911 network, resulting in a blurring of the difference between stationary, nomadic and mobile devices. For example, an IP-enabled mobile device may be capable of accessing the Internet via a Wi-Fi hotspot, a cable modem, or a 4G wireless broadband network. NG911 networks will need mechanisms to recognize which form of access the device is using when an emergency call is made and to provide the appropriate caller identification, location determination, call routing, and call signaling in each case.

26. NG911 also provides far more flexibility to provide network services that are not constrained by the location of the caller or the nearest PSAP to the caller. In circuit-switched networks, the location of many types of network services is constrained by the network topology. For example, a selective router has to be relatively close to the PSAPs it serves. For NG911, since call routing and media transport are completely disjoint, almost any network server can be located and replicated anywhere. As an example, a SIP proxy that routes call can be in a different part of the country, incurring only a few milliseconds of additional packet propagation delays.

27. While, as detailed above, the 911 system has been adapted to accommodate wireless and interconnected VoIP services, the success of the 911 system, combined with the antiquated aspects of today's 911 infrastructure and the development of advanced IP-based devices and applications in the telecommunications industry overall, creates a gulf between consumer assumptions about the system's robust capabilities and its actual limitations. Indeed, there is widespread concurrence among academics, industry experts, and politicians that “the current communications landscape is a far cry from the one for which the current 9-1-1 system was engineered” and, furthermore, that “our emergency communications networks are unable to accommodate what is increasingly viewed as basic functionality inherent in many of today's technologies.” In short, because 911 service was designed to succeed in the legacy wireline telephone environment, there are unmet consumer expectations concerning emergency service capability and reliability across new communications technologies (such as text messaging requests for help, sending IP-based information, including medical data, photos, videos, car collision telemetry, environmental sensors, gun shot sensors, etc. via smartphones, and delivering precise location information from behind MLTS systems).

28. The deployment of and transition to NG911 presents multiple opportunities for the benefit of public safety and homeland security. First, replacing today's system with a broadband-enabled, IP-based 911 network will offer far more flexibility, resilience, functionality, innovation potential, and competitive opportunities than is presently possible. NG911 holds the promise to bridge the gap between traditional means of voice-based communications and the advanced capabilities already in widespread use by consumers using smartphones, netbooks, and advanced wireless 4G. In particular these digital devices have powerful processor and storage capabilities and are capable of transmitting not only voice communications, but also text, data, telemetry, image, and video signals, which have benefits to particular communities such as persons with disabilities. Unlike the circuit-switched technology that lies at the heart of the legacy 911 system, today's wireless networks increasingly use all-digital packet switched technology based upon the Internet Protocol suite. Thus, while these networks are capable of conveying text, data, image, and video in addition to voice, the legacy 911 systems are not capable of receiving or processing these communications, and will not be until NG911 is deployed across the country.

29. The adoption of broadband IP-based technology also creates the potential for our 911 system to accommodate a full range of specialized devices and functionalities tailored to particular emergency response scenarios. For example, NG911 could permit the simultaneous transmission of critical health data along with a 911 call for help, both from the “caller” seeking assistance to a dispatcher, and back out from a dispatcher to a first responder arriving on scene or to an emergency room receiving the patient. Likewise, a vehicle's Automatic Collision Notification System could automatically call for help while conveying other relevant information such as the vehicle's location and the severity of the crash. NG911 will also enable 911 call routing based on caller characteristics, not just the location of the call. For example, a 911 call might be made via a video-enabled device by a deaf caller whose native language is American Sign Language. In this situation, rather than routing the call to the “geographically appropriate” PSAP, it may be preferable to enable the 911 system to route the 911 call to a PSAP that is video-enabled and has a 911 call taker prepared to respond to the caller using the caller's native sign language. NG911 will permit this to happen. NG911 will also create the ability to utilize a “virtual PSAP.” Today's 911 system generally requires a call taker to answer a 911 call from within the walls of a physical PSAP. In a NG911 network, however, a call taker will be able to answer a 911 call from virtually any location. This capability will be particularly advantageous during disasters and high call volume situations. NG911 will also complement the deployment of related next generation emergency communications networks, such as next generation alerting systems and advanced public safety broadband networks.

30. In this proceeding, we seek to gain a general understanding of NG911 and the applications that it supports. We examine and seek comment about how the applications and architecture of NG911 will affect the interface with the general public, the internal workings of PSAPs, and the interface with Emergency Medical Services (EMS) and other first responder organizations, including dispatch and database access. We then look at issues associated with implementing NG911 and how the transition from legacy 911 will impact the current architecture, structure, and costs of today's PSAPs over time. Finally, we seek comment on the proper roles of the FCC, other Federal agencies, and State, Tribal, and local governments in developing NG911 elements and facilitating the transition to NG911 over time.

31. In this section, we review the potential capabilities that the deployment of NG911 systems will provide to the public, and the likely architecture of NG911 networks. We seek comment on each of these elements as a component of NG911. Are there core elements that should be part of every NG911 system and standardized across all NG911 deployments? Are there non-core elements that could be part of NG911 but are optional or can be varied locally? How will these elements (both core and non-core) be affected by future technological change?

32. Because NG911 architecture is IP-based, NG11 networks have the potential to support a variety of non-voice communications applications or “media types.” There is broad consensus in the public safety community that NG911 should include some combination of non-voice media types, and to this end, NENA, the IETF, and others have been actively engaged in developing and harmonizing technical standards to support such IP-based NG911 solutions. In addition, the U.S. Department of Transportation and other Federal agencies have engaged in the development of standards in this area. We identify and discuss the most likely media types below, and seek comment on the potential for each of the media types to be supported in the development and deployment of NG911 networks. We also seek comment on whether there are any additional media types that we should consider for inclusion in NG911.

33. Message-Based Text. When using message-based text, two or more parties have the ability to send complete, typically short, text messages to each other. Examples include Short Message Service (“SMS”), instant messaging (“chat”) sessions, or web-based tools. To send a message-based text, a user must make an explicit action, such as hitting an SMS send key, or the return key on a keyboard. Chat sessions are bidirectional through their protocol definition. While services such as SMS consist of independent messages, they may be presented to the user as a thread of back-and-forth messages.

34. Real-Time Text. “Real-Time Text (RTT) is conversational text that is generally sent and received on a character-by-character basis. The characters are sent immediately (in a fraction of a second) once they are typed and are also displayed immediately to the receiving person(s). This functionality allows text to be used in the same conversational mode as voice.” RTT is viewed by many in the disability community as a replacement for the dated TTY technology and preferable, from a human interface perspective, to message-based text, as it more closely approximates the speed and flow of human voice conversation. RTT also prevents messages from crossing each other during a call, and for this reason may be preferred over SMS as a means of facilitating the exchange of information between the caller and the PSAP dispatcher.

35. Still Images (Photos). Still images are captured by a digital camera, typically encoded into a compressed file format, such as JPEG, and made available as a single data object (file). Still images may help 911 call takers and first responders assess the severity of an incident or apprehend a criminal suspect.

36. Real-Time Video. Real-time (live) video may be captured by a webcam, a camera built into a mobile phone, a networked security camera, or another video-capable device. The live nature of real-time video distinguishes it from streaming video, which is typically used for watching entertainment content. Real-time video will help first responders better gauge the scope and nature of an incident and will also help determine a caller's precise location.

37. Telemetry Data. Telemetry data includes all sensor measurements that quantify physical, chemical, or biological phenomena. Examples include vehicular information (such as current speed and crash-related data), biological and environmental sensors that measure wind and temperature, and physiometric sensors that measure human pulse rates.

38. Auxiliary Medical and other Personal Data. Auxiliary data would include relevant information about the caller's medical conditions and particular treatment needs, as well as information related to those categories. Such information could be provided on a prior-consent basis to the PSAP for forwarding to EMS personnel or other first responders.

39. We also seek comment on the degree to which each of the media types discussed above will be used as a primary versus a secondary form of communication on NG911 networks. By “primary” media, we refer to media that provide the basic communications link between the 911 caller and the PSAP during the emergency call. By “secondary” media, we refer to media that may convey additional information between the caller (or the device used by the caller) and the PSAP to augment the primary communication. Primary media will likely include voice, RTT, and text-based messaging (SMS, instant messaging), because to differing degrees, all of these media types will permit live conversations between the 911 caller and the PSAP. Thus, primary media can also be considered “conversational media.” Primary media will likely be used to convey the nature and location of an emergency to a PSAP. In some cases, primary media may not be available to a 911 caller ( e.g. , due to network congestion or end system limitations). In these cases, we seek comment on whether e-mail or social network status pages could possibly be used as the primary means of contacting a PSAP. Secondary media will likely include transmission of photos, live video, and sensor data ( e.g. , data acquired from sensors commonly found in mobile devices, vehicles, and medical monitoring systems). We envision a PSAP most frequently using secondary media to acquire supplemental information from a 911 caller or the caller's device.

40. The Commission seeks comment on what primary and secondary media types PSAPs and service providers will likely support. Should individual PSAPs be able to choose the media types that they will support, or should all PSAPs be expected or required to support a specific set of media types? Should different standards or requirements apply to primary conversational media as opposed to secondary non-conversational media? If secondary non-conversational media include the capability to transmit sensitive personal data, what privacy protection concerns are raised and how should they be addressed? Would changes in current laws, regulations, tariffs, and overall policies be needed to enable NG911 to support these media types and system features?

41. In light of the popularity and ubiquity of SMS, many consumers may assume that they are or will soon be able to text to 911. Indeed, consumer use of SMS has exploded in the past decade and billions of SMS messages are sent each day. Also, unlike some of the other media types discussed above, SMS is readily available on most mobile phones, and thus its implementation into the NG911 network may be one of the first steps in moving beyond a voice-only emergency calling framework. SMS, however, has limitations that will need to be addressed if it is to become a reliable means for emergency communications. For example, a recent study noted that SMS is an asynchronous messaging service that does not provide a means for the sender to know whether and when the message has reached its destination. In addition, the study noted that because each SMS is independent of its predecessors, it is difficult to ensure that messages within the same logical conversation are routed to the same destination.

42. Given these limitations, we seek comment on how the increasing use of SMS may impact emergency communications and whether NG911 networks should be configured to support SMS emergency communications. For example, are there any proposed technical standards or approaches that would sufficiently address routing and location concerns? Further, will it be possible to use the existing short code system to reach PSAPs? Are there measurement results for mobile-to-fixed messaging that indicate the reliability and delay of SMS delivery under specified circumstances? Would it be possible to add location information to SMS messages to help in routing such messages and, if so, how? Would it be possible to maintain session continuity across messages, e.g. , at the gateway between the cellular network and the IP network? Can end-system SMS applications address some of the location-related issues, e.g. , waiting to send an emergency SMS until location information has been acquired? Have there been trials or operational experiences using SMS within the NG911 architecture? Should SMS be considered primarily as a fall-back mechanism when voice communications are difficult or impossible to transmit? As wireless systems evolve to IP based 4G architectures, can the reliability and features of SMS messaging be improved for the purposes of emergency communications and if so, how?

43. We also seek comment on existing and future public expectations related to the use of SMS for emergency communications. Do consumers understand that currently available SMS generally does not support sending text messages to 911? Could the implementation of NG911 lead to changes in consumer expectations and public misunderstandings about SMS capabilities? Is there a need for programs to educate the public about the limitations of SMS for emergency communications, and if so, what entity should be responsible for developing such programs? Are there liability issues that could arise if consumers unsuccessfully attempt to use SMS for emergency communications?

44. According to the ICO Plan, “[t]he biggest gap between the technologies used for daily communication and those that can access 9-1-1 services is that for the deaf and people with hearing or speech impairments.” As noted in paragraph 11, supra, the Twenty-First Century Act directs the Commission to form the EAAC with the purpose of determining the most effective and efficient technologies and methods by which to enable access to NG911 emergency services by individuals with disabilities. Moreover, the Twenty-First Century Act provides that “[t]he Commission shall have the authority to promulgate regulations to implement the recommendations proposed by the [EAAC], as well as any other regulations, technical standards, protocols, and procedures as are necessary to achieve reliable, interoperable communication that ensures access by individuals with disabilities to an Internet protocol-enabled emergency network, where achievable and technically feasible.” In addition, the National Broadband Plan recommended that NHTSA include “an analysis of the needs of persons with disabilities and should identify standards and protocols for NG911 and for incorporating VoIP and ‘Real Time Text’ standards.” ICO has noted that when it analyzed trial deployments of IP-enabled emergency networks, texting access through various IP-devices, RTT, and third-party conferencing was successfully demonstrated. Additionally, streaming video and SMS were successfully demonstrated, but with key shortcomings.

45. The Commission seeks comment on what media types and devices (e.g., text, video) persons with disabilities will likely use to make an emergency call in an NG911 environment. We understand that some people with hearing and speech disabilities make emergency calls directly; others use telecommunications relay services (TRS), a more indirect method to make these calls. How can the Commission ensure that persons with disabilities receive the appropriate benefits from the NG911 system? What, if any, technical or accessibility requirements should be imposed to ensure that persons with disabilities have the necessary access to the NG911 system? To what extent can real-time text, which permits the live exchange of information with a PSAP during a call, assist individuals with hearing or speech disabilities who wish to call 911 directly? Finally, the Commission requires IP-based text and video relay providers to ensure the prompt and automatic call handling of emergency calls. What considerations are necessary to ensure effective access to NG911 services for callers who continue to rely on IP-based relay services for their 911 calls? Are there different considerations for individuals who continue to use PSTN-based relay services?

46. The Commission recognizes the significant public safety interest in ensuring that non-English speakers have access to emergency services. We seek comment on what media types non-English speakers likely will use to make an emergency call in an NG911 environment. What types of devices may non-English speakers use to make an emergency call in an NG911 environment? How can the Commission ensure that non-English speakers receive the appropriate benefits from the NG911 system?

47. The ability to share information—including medical information—could be of particular value to EMS and other first responders. Should such information be provided in the ordinary course to EMS and other first responders in a manner similar to the provision of medical condition information described in paragraph 37, supra? Since privacy protection concerns would seemingly be implicated in this case, as in the case of transmitted medical information, how should such concerns be addressed?

48. Independently of the Commission's efforts in connection with the EAAC, we seek comment on whether the Commission should conduct a separate rulemaking to ensure that individuals with disabilities have access to an Internet protocol-enabled emergency network, where achievable and technically feasible.

49. In this section, we seek comment on the mechanisms that will be used to transport digital content across NG911 networks. In an IP-based NG911 architecture, unlike a circuit-switched architecture, a variety of protocols can be used to transport media types across the network from the 911 caller to the PSAP. For example, still images can be carried: (1) As Multimedia Messaging Services (MMS) sent by mobile devices, (2) as attachments to Internet e-mail, (3) within instant images and uploaded to social network services, or (4) on other web services. We note that a diverse mix of physical infrastructures, networking protocols, applications, and devices may facilitate the carriage of potential NG911 media types from a 911 caller to a NG911-enabled PSAP. For example, some carriage scenarios may rely solely on “pure” IP-based solutions, some may rely heavily on existing legacy infrastructure, and some may rely on gateway packet-based communications between callers and PSAPs. We seek comment on each of these technical approaches and request that commenters discuss operational, business, and other policy strengths and weaknesses of each approach. For example, while application of IP-based approaches has generally led to robust and unexpected innovations in communications technologies, PSAPs could face operational and funding burdens from supporting a large number of IP-based NG911 architectures, and resources could be diverted from technical solutions that incorporate standardized features and implementation approaches. Similarly, introduction of operational requirements such as reliability, scalability, and standardized technology could result in tradeoffs between various legacy, proprietary, end-to-end open-standard, or other approaches for IP-based NG911 systems. We request that commenters identify these tradeoffs, or other relevant tradeoffs, and discuss the relative strengths and weaknesses of these technical approaches.

50. In the traditional 911 system, only a small number of entities participated in the provisioning of emergency calling services because an E911 call would originate from an end user device that was in practice tightly-coupled, both technically and administratively, with the service provider's transport network. Examples include a conventional wireline phone, a mobile phone, and an interconnected VoIP phone.

51. In a NG911 environment, however, end user devices are far more likely to be liberated from a particular transport network. This treatment acknowledges important industry trends, such as the increasing portability of devices among service providers, open access possibilities, and the increasing use of user-selected IP-based devices that may exploit widely-available sources of Internet access. As such, the number of participants in an NG911 environment will increase dramatically. The table below lists the potential NG911 participants and their possible roles in an NG911 environment.

52. Currently, only devices that provide telephone services are capable of transmitting 911 calls. In the future, however, most electronic devices will have communication capabilities, ranging from televisions, in-car systems, portable music players, tablet computers, and game consoles. We seek comment on what devices can usefully provide emergency calling services. Should every consumer device with Internet or cellular connectivity and a suitable user interface have the ability to request emergency assistance? Should such devices be certified and labeled as 911-capable? How will a user of a device or software be able to tell whether a device or communication software is capable of placing 911 calls? If this capability is conditional, e.g., on properly-configured network connectivity, can the user or device test 911 reachability?

53. In the E911 Scope Order, the Commission established the following four criteria for determining which licensees should be subject to the wireless enhanced 911 obligations: Those licensees that (1) offer real-time, two-way switched voice service, interconnected with the PSTN, either on a stand-alone basis or packaged with other telecommunications services; (2) whose customers clearly expected access to 911 and E911; (3) that competed with analog and broadband PCS providers; and (4) where it is technically and operationally feasible to provide enhanced 911 service. Should the Commission consider expanding or modifying the four criteria from the E911 911 Scope Order to apply to additional NG911 participants? For example, should hot-spot providers that are not traditional communications providers, such as coffee shops, hotels, bus lines, and public parks be expected to play a role in the deployment of NG911?

54. Many potential NG911 media types permit a range of encoding and performance parameters. For example, photos are typically compressed using the JPEG standard, but may also use other formats. Photos may also include meta data (EXIF), ranging from camera settings to embedded geographic location. Further, camera images can range from low-resolution web cam photos with less than one megapixel to professional-quality images with more than 15 megapixels and several megabytes in size. For text, accented and foreign language characters can be represented in a range of character encodings with Unicode in its UTF-8 encoding among the most popular. While a wide variety of digital formats are potentially available for encoding such information, NG911 will require use of compatible formats across the network, so that PSAPs can receive and process the text, photos, and other digital information that are sent by the public. We seek comment on how best to ensure such compatibility in the formatting and coding of text, photos, and other digital information. Should there be standards for media encodings? Should we specify minimal performance ranges, e.g., minimum file sizes for digital images, that NG911 networks must support and PSAPs be able to accept?

55. If there is a need to develop standards for digital information transported on NG911 networks, what entity should set and update these standards, or assist in their coordination? Should the standards be national or international? Are there standards efforts currently under way that could form the basis for future evolution in this regard? Should specific technical standards or architectures be mandated? How can the interoperability of end user devices and PSAP devices be ensured ( e.g., through interoperability testing)? Should there be a certification process that indicates whether a device or downloadable software application is compliant with certain standards? If so, what form of certification seems to be the most suitable, e.g., self-certification or approved certification organizations? Should all devices of a certain class be required to meet the certification criteria? As more people—especially within the disability community—begin to make video-based telephone calls, are there steps needed to ensure that NG911 networks interoperate seamlessly with the video software and applications being utilized in smart phones, tablets, computers and other devices? Similarly, are there steps needed to ensure interoperability with the video communication services provided by all video relay service providers?

56. As noted earlier, IP-based technology removes many of the location constraints of traditional circuit-switched technology. In particular, a PSAP no longer has to be in a single building at a fixed location. Call takers that are organizationally part of a single PSAP can be located virtually anywhere an Internet connection can be found, and a single call taker could be supporting multiple PSAPs. Such “virtual PSAP” arrangements may allow more flexible and efficient staffing and may allow PSAPs to better recover from major disasters by temporarily relocating operations. We seek comment on the potential for development of virtual PSAPs as part of the transition from legacy 911 to NG911. Are current technologies sufficient to support virtual PSAPs? Are there regulatory or legal barriers changes that are necessary to facilitate the development and operation of virtual PSAPs? Are there current PSAP databases that would need to be standardized to support a remote “virtual PSAP”? How could local data that is contained in current Computer Aided Dispatch Data Bases, MSAGs, and other repositories that are necessary for an efficient response by emergency personnel be distributed on a timely and reliable basis for use by non-local PSAPs?

57. While emergency service networks and PSAPs will continue to be operated and managed regionally, the deployment of NG911 may require a set of national infrastructure components. Based on the current NENA NG911 architecture, these may include: (1) A national PSAP and ESInet lookup directory, called the LoST “forest guide”; (2) a public-key cryptography certificate to ensure that other NG911 entities can authenticate PSAPs and to ensure that PSAPs are capable of receiving access to sensitive information; and (3) interconnection to an IP-based national network to ensure that emergency calls can be routed amongst PSAPs without PSAPs losing information. The Commission seeks comment on whether it is necessary to establish a national set of infrastructure components to ensure the deployment of NG911. If it is necessary, what entity should operate this national set of infrastructure components?

58. Device-Initiated Services for Emergency Communications. In an IP-based network architecture, emergency calls can be placed not only by human beings, but by a variety of automatically triggered devices. Examples of such devices include environmental sensors capable of detecting chemicals, highway cameras, security cameras, alarms, personal medical devices, telematics, and consumer electronics in automobiles. We seek comment on how the deployment of NG911 will facilitate the ability of device-initiated emergency services to reach PSAPs. What steps are needed to facilitate such deployment? Is there a need to modify existing laws, regulations, or tariffs to ensure that device-initiated emergency services have access to the NG911 network?

59. Social Media for Emergency Communications. How have consumers used social media to report an emergency or contact public safety during an emergency? How will consumers expect to use social media for emergency purposes in the future? To what extent might State and local public safety jurisdictions employ social media tools as a way to interact with the public? How will these tools impact the deployment of NG911?

60. N11 Numbers and Other Services for Emergency Communications. The basic functionality of NG911 is similar to many other location-based information and assistance services, such as 211 (community information and referral), 311 (non-emergency city services), 511 (traffic information), poison control, call-before-you-dig, and other similar services. Since these services share much of the same technical functionality, it may be possible to reduce cost and improve service by integrating some of these services to use a common technology platform. Further, callers may need to be transferred from one service to another, e.g., from 911 to 311 or 211. Can such coordination and integration be helpful and cut costs? How will the deployment of NG911 address N11 numbers, including N11 services such as 311, which is designated for non-emergencies? How will the deployment of NG911 impact other emergency services, such as poison control centers using 800 services? How will the deployment of NG911 affect TRS that use 711?

61. Auxiliary Data. NG911 offers the opportunity to provide additional data to PSAPs and first responders, such as the caller's medical history, a description of the caller's residence or business location, and related data, including building floor plans, information about hazardous materials, and building occupants with special needs. This data will often be maintained and provided by third parties, such as health care organizations that maintain electronic medical records or commercial landlords that maintain floor plans. How should the PSAP be informed about the availability of this data? What entity should associate this information with the call or message, such as the application service provider or a third party? Is there a need for regulations that require an application service provider to supply these services, e.g., by providing the appropriate call signaling or lookup functionality? Is there a need for standards to ensure that PSAPs and first responders receive access to this data without every PSAP having to make individual arrangements with each data source? Since this auxiliary data may be considered part of the 911 call record and therefore subject to public disclosure, is there a need to protect the privacy of this data differently than the remainder of the call information?

62. Disaster Planning and Recovery. How will NG911 facilitate disaster planning and recovery? How will NG911 interact with existing and future public alerting systems? Can national security be enhanced by the consistent implementation of interoperable NG911 systems across the nation? What key NG911 elements should be the focus for consistent implementation and interoperability?

63. MLTS for Emergency Communications in an NG911 Environment. Currently, MLTS operators are not subject to the FCC's E911 regulations. In 2003, the Commission found that economic and competitive factors existed that rendered it impracticable to adopt E911 requirements for MLTS. The Commission, however, sought comment on its “jurisdiction over MLTS operators, in light of the Commission's earlier interpretations of its section 4(i) authority and its prior statement that `the reliability of 911 service is integrally related to our responsibilities under section 1 of the Act.' ” In light of NG911's potential impact on MLTS, we seek comment on whether the Commission has the jurisdiction to regulate MLTS operators. How will the deployment of NG911 improve emergency services for MLTS users? Will MLTS operators be able to provide improved location information in an NG911 environment?

64. We seek comment on the potential operational, technical, and other challenges associated with the transition to NG911. As both the ICO Plan and the National Broadband Plan highlight, the transition to NG911 will be an evolutionary process, involving technological, economic, and institutional challenges. The ICO Plan also noted that “a timetable for national deployment of NG9-1-1 is difficult to estimate due to the lack of:

• Consistent funding for planning, training, deployment and implementation;

• Complete set of standards and time required to develop them; and

• Coordinated planning and implementation efforts by stakeholders at all levels (e.g., government, industry, OSPs, standards organizations).”

65. In light of these challenges, what actions should the Commission take to encourage the deployment of NG911? Have there been any recent developments that provide additional details on a potential timeline for NG911 deployment? Have there been any coordinated management efforts by State, Tribal, or local governments? Should there be a national set of milestones that provide a planning horizon? If so, what entity or entities should set those milestones, measure progress, and disseminate the measurement results? What are the milestones that will be useful to accelerate and measure NG911 deployment? What changes will need to take place in the emergency communications governance structures, at both the Federal and non-Federal levels, to facilitate NG911 planning and implementation? What policies can be established to enable and instigate the development and deployment of shared State-wide ESInet, and related cooperative working agreements between Federal, State, Tribal, and local agencies, as a fundamental 911 and emergency communications policy objective? Will waivers of certain rules and regulations be necessary during the transition to NG911? Should the FCC provide certain criteria for consideration of waiver grants?

66. Because the transition to NG911 is likely to be gradual rather than a large scale “flash cut,” what can be done to ensure that NG911 networks interoperate seamlessly with legacy networks? PSAPs will likely offer different capabilities for both primary and secondary media types during the transition to NG911; however, consumers in need of emergency services will also expect a uniform experience. For example, it may confuse consumers if they can use IP-based devices and applications to reach a PSAP in one county, but cannot use them to reach a PSAP in a neighboring county. Will the deployment of NG911 permit statewide or nationwide PSAPs to uniformly support new emergency communication capabilities? We seek comment on whether a timetable or deadline should be established for all PSAPs to support a minimal set of NG911 capabilities. Should we implement a timetable or deadline to ensure that all primary media types can be used to contact 911? Should certain media types, such as message-based text, only be permitted for emergency purposes when a threshold percentage of PSAPs across the country can accept these media types? Is fallback routing acceptable, where larger regional entities handle media types, such as SMS, when the local PSAP cannot? If this is not the best path forward, how should consumers determine what media types they can use to reach emergency services in their locality? Should NG911-enabled devices be able to automatically discover the local NG911 capabilities?

67. In the current 911 system, incumbent local exchange carriers are the primary 911 System Service Providers (SSPs); however, in the NG911 environment, there are likely to be multiple SSPs offering a variety of service capabilities and options. Thus, NG911 systems will provide the opportunity for competitive services to emerge in the 911 marketplace. However, as NENA has pointed out, there are many State, local, and Federal regulations that may inadvertently inhibit the transition to NG911. We seek comment on both the potential benefits and potential drawbacks of competition in the 911 marketplace. If competition does provide a benefit, what steps should be taken at both the Federal and non-Federal level to enable competition for the delivery of NG911 services?

68. Since many 911 laws and regulations were written in an era where the technological capabilities of NG911 did not exist, we seek comment on how legislative and regulatory bodies can modify their laws and regulations to ensure that they keep pace with the rapidly changing public safety marketplace. As NENA noted, “[d]uring the transition to NG9-1-1 * * * rights and obligations are unclear for those companies that are providers of IP services and seek to provide complete systems or components of 9-1-1 systems * * * [thus] * * * a clarification of rules impacting the delivery of 9-1-1 and emergency services is needed in the near term.” Given these new opportunities, what regulations should the Commission implement, or clarify, to facilitate an open and competitive NG911 environment?

69. How competitive is today's 911 system in terms of call routing, switching, transport, and database management services? Are there current laws and regulations that would inhibit an interoperable environment for NG911? Can these laws and regulations be modified to enable the IP-based, software, and database controlled structure of NG911? How do State laws and local ordinances that currently exclude non-voice based communications, automated 911 access, and sensors affect the deployment of NG911? Are disparate cost recovery mechanisms for originating 911 traffic and data costs and varying interconnection requirements impeding the transition to NG911? Do incumbent 911 system service providers have sufficient incentives to upgrade their technology absent regulatory change? Specifically, will NG911 architecture encourage more competition in the provision of 911 services? Should the FCC encourage such competition, and if so, how? What actions are necessary to optimize 911 governing authority choices for competitive NG911 SSPs, including the ability of governing authorities to act directly as SSPs? Should existing regulations, laws, or tariffs be modified to ensure that 911 governing authorities or new 911 SSPs are entitled to receive relevant routing, location, and other related 911 information at reasonable rates and terms? Should laws, regulations, and tariffs be modified to account for the responsibility of cost distribution for the decreasing use of shared legacy resources, such as legacy selective routers?

70. NENA has also recommended that the Commission examine its use of the term “wireline E9-1-1 network” as defined in section 9.3 of the Commission's rules. According to NENA, “[i]t could be argued that this definition would not allow for the routing of 9-1-1 calls via an IP-based NG9-1-1 system.” The Commission seeks comment on NENA's recommendation. What other regulations need to be modified or expanded to enable data based services and other NG911 capabilities, including the expansion of call routing from a location-only basis to more effective forms, such as caller characteristics or needs ( e.g., hearing or speech impaired, preferred language, etc. )?

71. NG911 will promote a more complex service delivery environment, with more types of services able to connect to NG911 systems, more external data sources available to PSAPs, and increased information-sharing options among emergency response agencies. While this flexibility promises to provide benefits to the public and PSAPs, it is also likely to create more complex liability issues and may require new forms of liability protection for providers of NG911-related services.

72. Liability concerns may arise in a variety of contexts, based on the variability and complexity of NG911 services. For example, PSAPs may face differing liability scenarios depending on whether they choose to receive all possible information from all devices or to limit their systems to receipt of certain information or devices. Moreover, because NG911 can provide far more detailed information in real time than legacy 911, new liability issues may arise if errors occur in the transition of such data. For example, a 911 call could arrive at a PSAP from a telematics-equipped vehicle with information on the severity of a crash along with information from the vehicle occupants' electronic health records. Based on this information, algorithms may be able to predict the probability of severe injury and suggest a certain type of response. These capabilities are intended to result in the appropriate level of care quickly being sent to victims in need of assistance; however, they may also result in unintentional errors and liability exposure. Liability issues may also arise from the transfer of emergency calls and data outside the NG911 system, such as among multiple national N11/800 numbers ( e.g., 211, 311, 811, 911, suicide hotline, poison control centers). The current ability to transfer calls and data among the multiple N11 entities is limited, but will not be as NG911 systems are deployed and N11 calls are able to be routed over shared networks. As a result, these entities may be exposed to liability.

73. These examples illustrate that NG911 may raise liability concerns both for PSAPs and for commercial providers of NG911-related services, and that liability protections may therefore need to be modified in an NG911 environment. Some of the new communication services that have been proposed for inclusion in the NG911 ecosystem may offer benefits to the intended user. However, in their present implementation, these services may not provide the reliability and quality of service that is associated with an emergency service. We seek comment on whether and how liability protections should be modified to ensure that NG911 service providers and PSAPs are adequately protected in an NG911 environment. How should the benefits of these new modes of communication be balanced against the potential liabilities they may introduce? Are there actions that the FCC can take, consistent with its statutory authority, in regard to modifying liability protections? Should liability protection extend to all forms of information pushed to a PSAP or pulled from external sources by a PSAP, regardless of the platform over which information travels? Should liability protection extend beyond the PSAP to all entities appropriately involved in the emergency response? Should the FCC review its requirement that all 911 calls be routed to the “geographically appropriate” PSAP to ensure that 911 calls are not prevented from being intelligently routed to the appropriate PSAP, even if it is not the geographically closest PSAP? Does the possibility of 911 calls being answered by a “virtual” PSAP give rise to liability concerns that would need to be addressed?

74. The legacy 911 system is a dedicated, closed, single-purpose system. Since information associated with a 911 call in today's system is generally stored in a single restricted location, preserving the confidentiality of the information and retaining appropriate records as required by law is relatively straightforward. Conversely, NG911 systems will be shared systems comprised of multiple entities. Indeed, the NG911 network may be only one part of a much larger system that will be shared with government, private sector, and other public safety entities. As previously noted, the number of media types that may be received by PSAPs and shared with emergency response agencies will greatly surpass that of current E911 systems.

75. In light of the shared nature of NG911 architecture, we seek comment on whether privacy laws or regulations will need to be modified to adapt to the NG911 environment. What privacy concerns will be introduced with the deployment of NG911? What existing or new regulations might be necessary to ensure appropriate privacy controls? Will the definition of a “911 call” need to be modified in certain statutes and rules? How should we address concerns regarding private personal information that may be transmitted as part of an NG911 communication, for example, personal medical information that NG911 can provide to PSAPs and other third parties? How can 911 call takers at virtual PSAPs legally access 911 call data when necessary, while requiring adherence to appropriate confidentiality, disclosure, and retention statutes and rules?

76. As noted in the ICO Plan, new location-based technologies and applications have generated an increased demand for location services, yet the decoupling of originating service providers from network operators will make the delivery of real-time, automatic location information more challenging. To what degree should Federal regulations require that access providers provide call location data to end systems and/or voice service providers on reasonable and non-discriminatory terms, using standard protocol interfaces? How can stationary, nomadic, and mobile end systems in wireline and non-cellular wireless networks (including Wi-Fi) reliably discover their location information to ensure call routing and dispatch? What, if any, obligations need to be imposed on Internet service providers, residential and enterprise equipment vendors, and other parties to ensure that location information can be discovered, conveyed, and validated? Is there a need for a national or regional certification entity that will allow a provider of location information to cryptographically sign the location information?

77. The IP-based nature of NG911 architecture, and its complex relationship with other systems, gives rise to concerns about maintaining the security, integrity, and reliability of NG911 networks and information. We seek comment on how to address these concerns. Will the deployment of NG911 allow increased security of information through role-based access control and data rights management that limits access to information only to authorized entities? What additional security concerns will be implicated by the transition to NG911 as compared to the legacy 911 security functionality? How can the NG911 network be protected against viruses, cyber attacks, fraudulent or harassing transmissions, and other unwarranted intrusions and interruptions?

78. What role will public information campaigns play in the transition to NG911? How can the Commission ensure that public safety personnel, consumers, and carriers are aware of NG911 deployments? What entities should lead and contribute to consumer education? Should the Commission foster common terms and terminology to facilitate the deployment of NG911? How can we ensure that other relevant organizations are aware of NG911's benefits, such as mobile health and telemedicine? Beyond the EAAC, how can we ensure that the disability community is involved with and aware of the transition to NG911?

79. Given the proliferation of services and devices that will be able to initiate emergency calls in an NG911 environment, there will likely be many more ways for callers to contact a PSAP, including those callers that do not have an active subscription with an application (voice) service provider, or do not have access privileges for the wireless network available at their current location.

80. We are concerned that unauthorized access to the NG911 network will increase the number of unintentional, prank, or malicious calls to a PSAP. However, there may be opportunities to reduce the risks by creating authorization models that are separate from traditional subscriber arrangements. As a hypothetical example, State motor vehicle authorities could provide, as part of their normal identity management operations, network and Application Service Provider (ASP) credentials that would be valid for emergency calls. We seek comment on whether such emergency-call-only credentials would be desirable and feasible? If so, how can they be implemented? What regulatory arrangements would be necessary to facilitate this emergency-call authentication?

81. Even if new authorization procedures can be developed, it may still be necessary for NG911 systems to support emergency communications in some circumstances where the caller cannot be identified. We seek comment on how this problem can be addressed. When would it be appropriate for the NG911 system to support emergency calls without authentication and/or authorization? Should ASPs be required to support emergency calls for zero-balance customers? Should providers of public and semi-public wireless data networks, such as 802.11 hot spots, be required to provide access for emergency calls?

82. Currently, an international traveler can make a 911 call in the United States as long as the traveler's mobile phone can connect to the local wireless network. In an NG911 environment, an international traveler's home ASP can route an emergency call to the appropriate PSAP in the United States, even if the ASP is located in another country. However, regulatory arrangements may be needed to make this call routing feasible. Should these types of calls be supported by NG911? What kind of arrangements and regulatory changes will be needed to facilitate these calls?

83. State, Tribal, and local governments are the primary administrators of the legacy 911 system and are responsible for establishing and designating PSAPs or appropriate default answering points, purchasing customer premises equipment, retaining and training PSAP personnel, and purchasing 911 network services. Certain communications technologies, however, necessitated the adoption of a uniform national approach. For example, following the introduction of CMRS in the United States, the Commission established rules requiring CMRS carriers to implement basic 911 and E911 services. In addition, Congress adopted the 911 Act to promote and enhance public safety through the use of wireless communications services. The 911 Act directed the Commission to designate 911 as the universal emergency assistance number for wireless and wireline calls, which the Commission accomplished in 1999. The 911 Act also required the Commission to consult and cooperate with State and local officials in its role of encouraging and supporting the deployment of “comprehensive end-to-end emergency communications infrastructure and programs.” Similarly, in applying E911 rules to interconnected VoIP in 2005, the Commission noted that a uniform national approach was necessary to ensure that the quality and reliability of 911 service would not be damaged by the introduction of new communications technologies that posed technical and operational challenges to the 911 system. In 2008, Congress codified these rules in the NET 911 Act.

84. The level and manner of State-level coordination of 911 services varies widely. In some states, 911 service is strictly a local matter. Other states have centralized the 911 program function or have otherwise established a statewide coordination mechanism, although their circumstances and authority vary widely. Another factor that varies widely is the extent to which states have coordinated their 911 systems with those of Tribal governments. Although the staffing of PSAPs and handling of 911 calls will generally remain a local function, certain aspects of transitioning to NG911 will require State-level planning and implementation coordination. For example, according to NENA, “ESInets will be developed and managed locally or regionally, but will need strong State-level leadership and coordination to ensure both operability and interoperability of State, local, and regional ESInets.” In light of the variation in State-level approaches to legacy 911, we seek comment on the ability of states to effectively coordinate the transition to NG911. Should each State designate an organization that will be responsible for planning, coordinating, and implementing the NG911 system in that particular State? Similarly, we seek comment on how coordination with Tribal governments is effectuated at the local level.

85. We also seek comment on whether there should be Federal oversight or governance of State deployment of NG911. The National Broadband Plan called on Congress to enact and the FCC to implement a Federal NG911 regulatory framework that confers Federal jurisdiction and oversight for the “development and transition to NG911 networks” while preserving “existing State authority for 911 services.” We seek comment on the extent of the FCC's jurisdiction to oversee the transition to NG911, since PSAPs, service providers, consumer device manufacturers, and software developers will all be involved. We also seek comment on the role that other Federal agencies, such as ICO and those entities with responsibilities to Tribal lands, should play. Should a single Federal entity be established to oversee the transition to NG911? Should there be a single Federal entity to ensure compliance with required standards, coordination, implementation, and policies? Should there be a national policy established by the Commission or another Federal entity to ensure consistent regulation? What entity should enable and instigate the development and deployment of shared State-wide ESInets and related cooperative working agreements between Federal, State, tribal, and local agencies? What functions and responsibilities should be performed at the Federal, regional, State, Tribal, and local levels in the implementation, transition to, and ongoing operation of NG911 in areas including networks, NG911 functional elements, databases, system operation, and PSAP operation? What statutory or regulatory changes, if any, would be necessary for the Commission, other Federal agencies, States, Tribes, or localities to facilitate and oversee NG911?

86. How should the FCC coordinate with other Federal agencies on issues related to the deployment of NG911, such as mobile health, telemedicine and disability access? How should the FCC and other Federal agencies coordinate with the states and Tribal governments? Should the FCC provide oversight to the states as they assume leadership roles in the transition to and implementation of NG911 systems within and between states?

87. This document does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 47 U.S.C. 3506(c)(4).

88. The inquiry this Notice initiates shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. Persons making oral ex parte presentations are reminded that memoranda summarizing the presentations must contain summaries of the substance of the presentations and not merely a listing of the subjects discussed. More than a one or two sentence description of the views and arguments presented generally is required. Other requirements pertaining to oral and written presentations are set forth in section 1.1206(b) of the Commission's rules.

89. Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed using: (1) the Commission's Electronic Comment Filing System (ECFS), (2) the Federal Government's eRulemaking Portal, or (3) by filing paper copies. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

• Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/ or the Federal eRulemaking Portal: http://www.regulations.gov.

• Paper Filers: Parties who choose to file by paper must file an original and four copies of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.

• Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

• All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St., SW., Room TW-A325, Washington, DC 20554. The filing hours are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.

• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.

• U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street, SW., Washington DC 20554.

90. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

91. Accordingly, it is ordered that, pursuant to the authority contained in sections 4(i), 4(j), 10, 218, 303(b), 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 160, 218, 303(b), 303(r), and 403, this Notice of Inquiry is adopted.

Section 203 of the National Traffic and Motor Vehicle Safety Act of 1966 directs the Secretary of Transportation to prescribe standards establishing “a uniform quality grading system for motor vehicle tires.” 49 U.S.C. 30123. Those standards are found at 49 CFR 575.104. To aid consumers in making an informed choice in the purchase of passenger car tires, the standards require motor vehicle and tire manufacturers and tire brand owners to label such tires with information indicating their relative performance in the areas of treadwear, traction and temperature resistance. See 49 CFR 575.104(a).

The Uniform Tire Quality Grading Standards (UTQGS), 49 CFR 575.104, state that tire traction is “evaluated on skid pads that are established, and whose severity is monitored, by the NHTSA both for its compliance testing and for that of regulated persons.” 49 CFR 575.104(f)(1). As further described in the standards, the test pads are paved with asphalt and concrete surfaces that have specified locked wheel traction coefficients when evaluated in a manner prescribed in the standards. The traction skid pads are located at NHTSA's San Angelo Test Facility. 49 CFR 575.104, App. B. In addition to this government test facility, traction skid pads have been constructed at several commercial facilities.

The current fees charged for use of the traction skid pads at the San Angelo Test Facility, as well as fees charged for course monitoring tires, were established by final rule published in the Federal Register on August 2, 1995. See 60 FR 39269 (Aug. 2, 1995). 1 Pursuant to Appendix D to 49 CFR 575.104, the fees charged to manufacturers for use of the Government traction skid pads continue in effect until adjusted by the Administrator of NHTSA.

This NPRM proposes to update, in accordance with Office of Management and Budget (OMB) Circular A-25, the fee charged to manufacturers for use of the agency's traction skid pads at the San Angelo Test Facility. It also proposes to remove provisions concerning the fees charged for course monitoring tires, as NHTSA no longer supplies these tires for purchase by manufacturers. Based on a current assessment using a “market price” analysis as outlined below, NHTSA proposes to update the fees for use of the facility from $34.00 an hour, established in 1995, to $125 an hour. As discussed below, NHTSA believes that this proposed fee reflects the current market price for use of traction skid pads.

OMB Circular A-25 establishes Federal policy regarding fees assessed for Government services and for sale or use of Government goods or resources. The Circular expresses the general policy that “[a] user charge * * * will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public.” According to the Circular, a “special benefit” accrues and a user charge is assessed when a Government service “is performed at the request of or for the convenience of the recipient, and is beyond the services regularly received by other members of the same industry or group or by the general public.” Manufacturer use of NHTSA's testing facility is a special benefit because use of the facility is beyond the services regularly received by the industry or the general public. 2 Accordingly, NHTSA assesses a user charge for the use of the traction track.

For the purposes of assessing user charges, the Circular requires that, when the Government is acting in its capacity as sovereign, user charges be sufficient to recover the full cost to the Government of providing the good or service. When the Government is not acting as sovereign, however, user charges are to be based on market prices. The Government acts in its capacity as sovereign when it uses powers over which it has a monopoly. See e.g. , U.S. v. Reyes , 87 F.3d 676, 681 (5th Cir. 1996). The Government may act in a sovereign capacity, for example, when it is the only source of a good or service, such as where the Government issues a license. See National Park Service—Special Park Use Fees , B-307319, *6 (Aug. 23, 2007).

The agency is not acting in its capacity as sovereign in making the San Angelo Test Facility available for traction testing by manufacturers. That facility serves primarily for NHTSA's own compliance testing of manufacturers' tires. As we recently stated with regard to the UTQGS regulations, manufacturers are not restricted to the use of the traction skid pads at the government facility in San Angelo. Rather, manufacturers may test their tires wherever they choose. See 75 FR 15894, 15913 (March 30, 2010). 3 Because NHTSA's own compliance tests are conducted at the San Angelo Test Facility, tire manufacturers often choose to do so as well.

Pursuant to Circular A-25, “`Market price' means the price for a good, resource, or service that is based on competition in open markets, and creates neither a shortage nor a surplus of the good, resource, or service.” Where there is substantial competitive demand for a good, resource, or service, the market price is determined by commercial practice, for example, by competitive bidding, or by reference to the prevailing price of the same or similar good, resources, or services, adjusted to reflect demand, level of service and quality of the good or service.

To determine the appropriate market price for use of the San Angelo Test Facility, NHTSA surveyed several commercial facilities with traction skid pads available for public use. Prices for the hourly use of traction skid pads ranged from approximately $115 per hour to approximately $200 per hour. From its own experience, NHTSA believes that discounted rates may be available based on volume use or advance planning. Accordingly, NHTSA believes it is appropriate to take the availability of discounts into account in arriving at a determination of market rate. Taking a conservative approach, we propose to set the rate for use of the traction skid pads at the lower end of this range—$125 per hour. NHTSA welcomes comments regarding whether our proposed rate for hourly use of the traction skid pads at the San Angelo Test Facility accurately reflects the market price for such services.

Interested persons are invited to comment on this notice of proposed rulemaking. The procedure for submitting comments is noted below.

Your comments must be written and in English. To ensure that your comments are correctly filed in the Docket, please include the docket number at the beginning of this NPRM in your comments. Your primary comments cannot exceed 15 pages. See 49 CFR 553.21. We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach additional documents to your primary comments. There is no limit to the length of the attachments.

Please submit your comments by any of the following methods:

• Federal eRulemaking Portal: go to http://www.regulations.gov. Follow the instructions for submitting comments to the electronic docket site by clicking on “Help” or “FAQ.”

• Mail: Docket Management Facility, M-30, U.S. Department of Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590.

• Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE., between 9 am and 5 pm Eastern Time, Monday through Friday, except Federal holidays.

• Fax: (202) 493-2251.

• If you are submitting comments electronically as a PDF (Adobe) file, we ask that the documents submitted be scanned using Optical Character Recognition (OCR) process, thus allowing the agency to search and copy certain portions of your submissions. 4

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

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

If you wish to submit any information under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Chief Counsel, NHTSA, at the address given above under FOR FURTHER INFORMATION CONTACT . When you send a comment containing information claimed to be confidential business information, you should include a cover letter setting forth the information specified in our confidential business information regulation. See 49 CFR 512.

In addition, you should submit a copy, from which you have deleted the claimed confidential business information, to the Docket by one of the methods set forth above.

We will consider all comments received before the close of business on the comment closing date indicated above under DATES. To the extent possible, we will also consider comments received after that date. Therefore, if interested persons believe that any new information the agency places in the docket affects their comments, they may submit comments after the closing date concerning how the agency should consider that information for the final rule.

You may read the materials placed in the docket for this document ( e.g. , the comments submitted in response to this document by other interested persons) at any time by going to http://www.regulations.gov. Follow the online instructions for accessing the dockets. You may also read the materials at the Docket Management Facility by going to the street address given above under ADDRESSES . The Docket Management Facility is open between 9 am and 5 pm Eastern Time, Monday through Friday, except Federal holidays.

Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), provides for making determinations whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and to the requirements of the Executive Order. The Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities or the principles set forth in the Executive Order.

NHTSA has considered the impact of this rulemaking action under Executive Order 12866 and the Department of Transportation's regulatory policies and procedures. This rulemaking is not significant as it does not implicate any of the above-enumerated concerns. Accordingly, the Office of Management and Budget has not reviewed this rulemaking document under Executive Order 12886. Further, NHTSA has determined that the rulemaking is not significant under the Department of Transportation's regulatory policies and procedures.

Based on the type of fees and the anticipated use of the test track, NHTSA believes that the costs of the final rule would be minimal and would not warrant preparation of a regulatory evaluation. The proposed rule would increase fees charged to private manufacturers for use of a government facility to prevailing market rates. Manufacturers have a choice as to whether to use this government facility or a private commercial facility. As a result, this action does not involve any substantial public interest or controversy. Furthermore, NHTSA anticipates that any impact on the sale price of tires would be minimal, because an increase in testing fees would likely be distributed across a manufacturer's sales volume. There would be no substantial effect upon State and local governments. There would be no substantial impact upon a major transportation safety program.

NHTSA has evaluated this proposed action for purposes of the National Environmental Policy Act and has determined that it would not have a significant effect on the quality of the human environment.

NHTSA has considered the impact of this proposed rulemaking under the Regulatory Flexibility Act (5 U.S.C. 601 et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996). NHTSA believes that the proposed rule would not have a significant economic impact on a substantial number of small entities.

The following is NHTSA's statement providing the factual basis for the certification (5 U.S.C. 605(b)). Tire manufacturers are not small entities. The proposed amendments would affect businesses that conduct contract traction testing, some of which are small businesses within the meaning of the Regulatory Flexibility Act; however, the agency does not believe that this proposed rule would result in a significant economic impact on these entities. Under the proposed standards, the fees paid for use of the government facility would be essentially equivalent to those paid to a commercial testing facility—the market rate. The agency believes that small governmental jurisdictions would be only minimally affected by the proposed rule since they are generally not large scale purchasers of vehicles tires. Furthermore, even in the case of substantial purchases, as noted above, costs passed on to consumers are expected to be minimal since testing fees would likely be distributed across a manufacturer's sales volume.

Executive Order 13132 on “Federalism,” 64 FR 43255 (Aug. 10, 1999), requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications.” Executive Order 13132 defines the term “policies that have federalism implications” to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, NHTSA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal Government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or NHTSA consults with State and local officials early in the process of developing the proposed regulation.

The proposed rule would not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government as specified in Executive Order 13132. Accordingly, Section 6 of the Executive Order does not apply to this rulemaking action.

Pursuant to Executive Order 12988 “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), NHTSA has considered whether this rulemaking would have any retroactive effect. The proposed rule would not have any retroactive effect.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or Tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with the base year of 2005). Adjusting this amount by the implicit gross domestic product price deflator for 2009 results in $135 million (109.770/81.536 = 1.35).

This proposed rule will not result in the expenditure by State, local, or Tribal governments, in the aggregate, of more than $135 million annually, and will not result in an expenditure of that magnitude by private entities. Because a final rule based on this proposal would not require expenditures exceeding $135 million annually, this action is not subject to the requirements of Sections 202 and 205 of the UMRA.

Under the procedures established by the Paperwork Reduction Act of 1995 (PRA), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. The proposed rule does not require the collection of information by a Federal agency. Accordingly, the PRA is not applicable to this action.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN that appears in the heading on the first page of this document to find this action in the Unified Agenda.

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

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

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that isn't clear?

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

• Would more (but shorter) sections be better?

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

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

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

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an organization, business, labor union, etc. ). You may review DOT's complete Privacy Act statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit http://www.dot.gov/privacy.html .

In consideration of the foregoing, NHTSA proposes to amend 49 CFR Part 575 as follows:

Atlantic tunas are managed under the dual authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Atlantic Tuna Conventions Act (ATCA), which authorizes the Secretary of Commerce (Secretary) to promulgate regulations as may be necessary and appropriate to implement recommendations of ICCAT. The authority to issue regulations under the Magnuson-Stevens Act and ATCA has been delegated from the Secretary to the Assistant Administrator for Fisheries, NOAA (AA). On May 28, 1999, NMFS published in the Federal Register (64 FR 29090) final regulations, effective July 1, 1999, implementing the Fishery Management Plan for Atlantic Tunas, Swordfish, and Sharks (1999 FMP). On October 2, 2006, NMFS published in the Federal Register (71 FR 58058) final regulations, effective November 1, 2006, implementing the 2006 Consolidated HMS FMP, which details the management measures for Atlantic HMS fisheries including the PLL fishery.

NMFS is issuing a proposed rule that would require the use of “weak hooks” by PLL vessels fishing in the GOM. A weak hook is a circle hook that meets NMFS' current size and offset restrictions but is constructed of round wire stock that is thinner-gauge ( i.e., no larger than 3.65 mm in diameter) than the circle hooks currently used in the PLL fishery. The purpose of the proposed action is to reduce PLL catch of Atlantic BFT in the GOM, which is the only known BFT spawning area for the western Atlantic stock of BFT. This measure would also be consistent with the ICCAT SCRS advice that ICCAT may wish to protect the strong 2003 year class until it reaches maturity and can contribute to spawning. Implementation of weak hooks in the GOM PLL fishery by spring 2011 is important because the strong 2003 year class is beginning to enter adulthood, and it is likely that some of them will begin to spawn in the GOM this spring. Also, reducing the incidental BFT catch in the GOM may enable the PLL fishery to continue to operate year-round by increasing the likelihood that landings and dead discards will remain below the quota. The proposed rule would require a new gear technology that could allow the GOM PLL fleet to continue routine directed fishing operations ( e.g., yellowfin tuna (YFT) and swordfish) while decreasing the numbers of incidentally caught BFT. Weak hooks can allow incidentally hooked BFT to escape capture because the hooks are more likely to straighten when a large fish is hooked, thus releasing the fish.

This action is necessary to achieve domestic management objectives under the Magnuson-Stevens Act, and to implement the 2006 Consolidated HMS FMP, including goals to rebuild stocks and end overfishing. Atlantic BFT has historically been documented as overfished with overfishing occurring. Since 1998, an ICCAT rebuilding plan, which was implemented in the Consolidated HMS FMP, has been in place with the goal of rebuilding the western BFT stock by 2019. Strict quotas and domestic regulations have been in place to achieve this goal, including a prohibition on all directed fishing on BFT in the GOM in recognition that is the sole known spawning area for the western BFT stock. Although directed fishing for BFT is prohibited in the GOM, the incidental catch of BFT has become an area of heightened concern due to the status of the stock and mortality of incidentally caught spawning BFT in the directed PLL fishery that targets YFT and swordfish. Furthermore, a recent stock assessment conducted by ICCAT's SCRS in October 2010, shows that a strong 2003 year class is expected to begin to contribute to an increase in spawning biomass after several years. In particular, the SCRS notes “that the 2010 assessment is the first time that this strong 2003 year-class has been clearly demonstrated, likely as a result of age assignment refinements resulting from the growth curve and additional years of data; more observations from the fishery are required to confirm its relative strength. A further concern is that subsequent year-classes, although even less well estimated, are the lowest observed values in the time series. The Commission may wish to protect the 2003 year class until it reaches maturity and can contribute to spawning.” While the increased presence of spawning BFT in the GOM could provide a positive impact on the stock, PLL interactions with spawning BFT could also be expected to increase with the higher number of fish in this year class. This could lead to increased incidental catches (and discards) of BFT, potentially diminishing the reproductive impact of this large year class to the western BFT stock.

Several other factors have also heightened concern about BFT recently, such as the April 2010 Deepwater Horizon/BP oil spill in the GOM and potential impacts on BFT, particularly in the GOM. In addition, some environmental groups have called for the suspension of the entire Atlantic BFT fishery and the creation of a permanent BFT sanctuary in the GOM spawning area. In May 2010, the Center for Biological Diversity petitioned NMFS to list BFT as threatened or endangered under the Endangered Species Act and to designate critical habitat for the species. NMFS published a 90-Day Finding on the Petition to List Atlantic Bluefin Tuna as Threatened or Endangered under the Endangered Species Act on Sept. 21, 2010 (75 FR 57431). The analysis of that petition is ongoing.

Tuna researchers working on tagging projects in the GOM have noted that almost all BFT caught by PLL vessels are dead due to the high metabolic stress endured during capture from the warm water. Promising research results, from an experiment (the weak hook study) conducted by the NMFS Harvesting Systems and Engineering Branch, Pascagoula, MS, have found over the past 3 years that the weak hook, which is designed to bend under pre-determined loads, could potentially result in the quick release of large BFT, as well as some large pelagic sharks in PLL fisheries. The PLL vessel operators and owners involved in the study have shown support for use of weak hooks. Initial results show the potential for increasing the biomass of the western BFT stock in the short- and long-term with some potential adverse impacts to directed fisheries (i.e., approximately a 7 percent reduction in YFT and 41 percent reduction in swordfish retained for sale).

On an annual basis, ICAAT issues the United States its BFT quota, which is further divided among fisheries under the Consolidated HMS FMP. Under the Consolidated HMS FMP, PLL vessels are currently allocated 8.1 percent of the available landings quota for the incidental retention (and dead discards) of BFT while directing on other target species such as YFT and swordfish in the GOM and swordfish in the North Atlantic. In the last few years however, the total PLL landings and dead discards, all of which must be reported to ICCAT, have exceeded the Consolidated HMS FMP-based PLL allocation ( i.e. , landings and dead discards comprised 23 percent of the U.S. catch in 2009, substantially more than the 8 percent allocation of the U.S. quota assigned for the PLL fishery). Beginning in 2007, to provide quota sufficient for the PLL fleet to operate for the entire fishing year (based on the best available estimates of discards and landings), NMFS has added to the Longline category sub-quota a substantial portion of quota unharvested by other categories in the prior year. In 2008 and 2009, NMFS provided 54 mt and 83 mt, respectively, during the annual quota specification process to cover the Longline category sub-quota overages. After 2010, the amount of unharvested ICCAT-issued quota that the United States may carry forward to the subsequent year will be substantially reduced (from 50 percent of the total U.S. quota to 10 percent). In addition, if U.S. quota for 2011 and beyond remains at current levels, or less, there is the potential that other directed BFT fisheries ( e.g. , commercial and recreational handgear fisheries) may fully utilize their sub-quotas. Under these types of quota constraints, NMFS may, in future years, have to consider closing the PLL target fisheries to avoid further incidental catch of BFT or consider closing directed BFT fisheries in order to manage the fishery within the available U.S. quota and FMP-based quota allocations.

The objectives of this proposed rulemaking are to: (1) Enhance stock rebuilding by increasing BFT spawning potential and subsequent recruitment into the fishery, ( i.e. , rapidly implement the proposed action to increase the survival of spawning BFT in 2011 in the GOM particularly the 2003 year class); (2) constrain PLL BFT catch to the incidental BFT quota allocation; (3) allow the PLL fleet to continue to participate in their directed fisheries ( e.g. , YFT and swordfish) year-round with less risk of fishery interruption due to insufficient incidental quota availability ( i.e. , minimize negative social and economic impacts to the PLL directed fisheries); (4) reduce the need for BFT quota reallocation from directed fisheries or the Reserve to cover PLL BFT bycatch ( i.e. , minimize negative and social impacts to BFT directed fisheries); and (5) minimize negative ecological impacts on non-target or protected species.

As required by current regulation under the authority of ATCA, the retention of BFT in the PLL fishery is allowed incidentally to the targeted catch of YFT and swordfish. This incidental catch of BFT must be within the target catch retention limits of one BFT per 2,000 lbs of target catch, two BFT per 6,000 lbs, and three BFT per 30,000 lbs. BFT that are caught in excess of these existing target catch retention limits must be discarded and, for purposes of the discussion in this proposed rule, may be considered bycatch. Bluefin tuna that are discarded dead are counted against the quota along with landed BFT. In this proposed rule and related to BFT in the PLL fishery, the terms “incidental catch” and “bycatch” are used within this context.

A brief history on the management of the PLL fishery is provided below as it pertains to this proposed action. A more complete summary of Atlantic HMS management can be found in the 2006 Consolidated HMS FMP, in the annual HMS SAFE Reports, and online at http://www.nmfs.noaa.gov/sfa/hms/.

NMFS has implemented a series of management measures designed to regulate the incidental catch of BFT in non-directed Atlantic fisheries. In 1981, NMFS prohibited the use of longlines for any directed BFT fishery, implemented incidental catch limits, and established northern and southern management areas where different catch limits applied (46 FR 8012, January 26, 1981). PLL fishermen were restricted to two BFT per vessel per trip in the southern region and 2 percent by weight of all other fish on board in the northern region. In 1982, ICCAT recommended a ban on directed fishing for BFT in the GOM. Over the following decade, the value of BFT increased dramatically and fishing practices evolved with respect to incidental catch of BFT. In response, NMFS established various management measures to discourage PLL vessels from developing a directed fishery for this valuable species while allowing for the retention of some incidentally caught BFT, which included altering target catch requirements and adjusting geographic management areas (57 FR 365, January 6, 1992).

Despite these efforts, incidental catch of BFT by U.S. PLL vessels continued. NMFS continued to evaluate management alternatives to achieve a balance between allowing the retention of true incidentally-caught BFT while preventing a directed fishery and reducing discards.

On May 28, 1999, NMFS published in the Federal Register (64 FR 29090) final regulations, effective July 1, 1999, implementing the Fishery Management Plan for Atlantic Tunas, Swordfish, and Sharks (1999 FMP). As part of the 1999 FMP, the regulations for all Atlantic HMS, including billfish, were consolidated into one part of the Code of Federal Regulations, 50 CFR Part 635. The 1999 FMP was the first FMP for Atlantic tunas and included numerous management measures governing all HMS fisheries including the sub-allocation of 8.1 percent of the United States' overall ICCAT allocated quota for BFT landed by PLL vessels incidental to directed fishing operations targeting other species. Other highlights from the 1999 FMP included a measure to close an area of ocean off the Mid-Atlantic Bight to PLL fishing during the month of June in an attempt to minimize bycatch of BFT and ensure compliance with ICCAT recommendations. The HMS FMP also considered, but did not implement, further modifications to target catch requirements because of the difficulty in determining catch levels and landings allowances that would likely reduce dead discards.

NMFS also stated that a comprehensive approach to time/area closures would be undertaken as part of a bycatch reduction strategy after further analysis of the data and consultation with the HMS and Billfish advisory panels. This led to the development of a draft Technical Memorandum, which was made available to the public on November 2, 1999 (64 FR 59162).

Subsequent to the release of the Technical Memorandum, NMFS considered three alternative actions to reduce bycatch and/or bycatch mortality in the Atlantic HMS PLL fishery: status quo, gear modifications that would decrease hook-ups and/or increase survival of bycatch species, and the prohibition of PLL fishing (closures) in areas where rates of bycatch are higher. A proposed rule was published December 15, 1999 (64 FR 69982), for which alternatives were identified and analyzed in a draft Supplemental Environmental Impact Statement (64 FR 73550, December 30, 1999), that included proposed closed areas for PLL gear in the western GOM and off the southeast coast of the United States.

During the comment period on the proposed rule, NMFS received comments on many issues related to the proposed time/area closures. In particular, commenters asserted that a proposed closure in the western GOM would not adequately address juvenile swordfish bycatch in the DeSoto Canyon area of the eastern portion of the Gulf. Additionally, commenters noted the significant economic impacts associated with large scale area closures on vessel operators and shoreside support services that would need considerable time for adjustment and relocation. Given these comments, NMFS analyzed the potential impacts of an additional closed area in the DeSoto Canyon area. Subsequently, NMFS published supplementary information regarding the potential impacts of closing the DeSoto Canyon Area together with a revised summary of the IRFA prepared for the proposed rule (65 FR 24440, April 26, 2000). The comment period for the proposed rule was reopened through May 12, 2000, and NMFS specifically requested comments on the extent to which delayed effectiveness of the closure could mitigate the economic impacts of area closures.

On August 1, 2000, NMFS published a final rule that prohibited live bait longlining in the GOM and prohibited PLL fishing at any time in the DeSoto Canyon area (beginning November 2000) and East Florida Coast (beginning February 2001), and from February through April of each year in the Charleston Bump area (beginning February 2001) (65 FR 47214, August 1, 2000). In the PLL fishery, some species of sea turtles are sometimes caught or become entangled in the fishing gear. Because sea turtle species are listed as threatened or endangered under the Endangered Species Act (ESA), provisions of the ESA, such as Section 7 Consultation apply to the PLL fishery. During the course of the August 1, 2000, rulemaking, the PLL fleet exceeded the incidental take statement for sea turtles established during the ESA Section 7 Consultation for the 1999 FMP. That, combined with new information on sea turtles and the uncertainty regarding the effect of the closures on sea turtles, resulted in reinitiation of consultation and issuance of a new Biological Opinion (BiOp) (June 30, 2000), which concluded that the continuation of the PLL fishery as proposed was likely to jeopardize the continued existence of leatherback and loggerhead sea turtles.

As a result of the June 2000 BiOp jeopardy finding, NMFS needed to implement certain measures to reduce sea turtle bycatch in the PLL fishery. NMFS decided that further analyses of observer data and additional population modeling of loggerhead sea turtles would be needed to determine more precisely the impact of the PLL fishery on sea turtles. Because of this, NMFS reinitiated consultation on the HMS fisheries on September 7, 2000. In the interim, NMFS implemented emergency regulations, based on historical data on sea turtle interactions, to reduce the short-term effects of the PLL fishery on sea turtles, including the closure of a portion of the Northeast Distant Statistical Area (NED) and a requirement that dipnets and line clippers be carried and used on PLL vessels to aid in the release of any captured sea turtle. These regulations published on October 13, 2000 (65 FR 60889).

NMFS issued a BiOp on June 8, 2001 (revised on June 14, 2001), which again concluded that the continued operation of the Atlantic PLL fishery was likely to jeopardize the continued existence of loggerhead and leatherback sea turtles. Accordingly, the BiOp provided a reasonable and prudent alternative (RPA) to avoid jeopardy. The RPA included the following elements: Closing the NED area effective July 15, 2001, and conducting a research experiment in this area on various PLL gear modifications to reduce sea turtle bycatch and bycatch mortality in the PLL fishery. The BiOp also included a requirement that all vessels permitted for HMS fisheries post sea turtle handling and release guidelines. This requirement was modified to specify its application only to bottom and PLL vessels by an August 31, 2001, memorandum from the Office of Protected Resources.

On July 13, 2001, NMFS published an emergency rule (66 FR 36711) to implement several of the June 2001 BiOp requirements. NMFS published an amendment to the emergency rule to incorporate the change in requirements for the handling and release guidelines that were published in the Federal Register on September 24, 2001 (66 FR 48812).

On July 9, 2002, NMFS published the final rule (67 FR 45393) implementing measures required under the June 14, 2001 BiOp on Atlantic HMS to reduce the incidental catch and post-release mortality of sea turtles and other protected species in HMS fisheries, with the exception of the gangion placement measure. The rule implemented the NED closure, required the length of any gangion to be 10 percent longer than the length of any floatline if the total length of any gangion plus the total length of any floatline is less than 100 meters, and prohibited vessels from having hooks on board other than corrodible, non-stainless steel hooks. The final rule also required all HMS bottom and PLL vessels to post sea turtle handling and release guidelines in the wheelhouse. NMFS did not implement the gangion placement requirement because it appeared to result in an unchanged number of interactions with loggerhead sea turtles and an apparent increase in interactions with leatherback sea turtles.

During this time frame, NMFS again proposed changes to the PLL BFT target catch requirements and other modifications to the Longline category regulations in December 2002 (67 FR 78404, December 24, 2002). The May 2003 final rule set the incidental retention/target catch requirements as follows: One large medium or giant BFT per vessel per trip may be landed, provided that at least 2,000 lb (907 kg) of species other than BFT are legally caught, retained, and offloaded from the same trip and are recorded on the dealer weighout slip as sold; two large medium or giant BFT may be landed incidentally to at least 6,000 lb (2,727 kg) of species other than BFT; and three large medium or giant BFT may be landed incidentally to at least 30,000 lb (13,620 kg) of species other than BFT (68 FR 32414 May 30, 2003). The final rule also set Longline category allocations at no more than 60 percent of the Longline category quota for landing in the area south of 31 degrees north latitude. Twenty-five mt are allocated for incidental catch by PLL vessels fishing in the Northeast Distant gear restricted area. The required advance notice for any inseason adjustment to target catch requirements was set at 21 days. These target catch requirements and subquota allocations remain in effect today.

On November 28, 2003, based on the conclusion of the NED experiment and based on preliminary data indicating that the Atlantic PLL fishery may have exceeded the ITS established in the June 14, 2001 BiOp, NMFS published a Notice of Intent (NOI) to prepare a Supplemental Environmental Impact Statement (SEIS) to assess the potential effects on the human environment of proposed alternatives and actions under a proposed rule to reduce sea turtle bycatch (68 FR 66783).

In January 2004, NMFS reinitiated consultation after receiving data that indicated the Atlantic PLL fishery exceeded the ITS for leatherback sea turtles in 2001-2002 and for loggerhead sea turtles in 2002. In the spring of 2004, NMFS released a proposed rule to require PLL fishermen to use certain hook and bait types, and take other measures to reduce sea turtle takes and mortality. The resulting June 1, 2004 BiOp considered these measures and concluded that the PLL fishery as proposed was not likely to jeopardize the continued existence of loggerhead sea turtles, but was still likely to jeopardize the continued existence of leatherback sea turtles.

On July 6, 2004, NMFS published a final rule (69 FR 40734) pursuant to the 2004 PLL BiOp implementing many gear and bait restrictions and requiring certain sea turtle handling and release tools and methods. Specifically, the 2004 final rule required vessel operators participating in the PLL fishery for Atlantic HMS operating outside of the NED, at all times, to possess onboard and/or use only 16/0 or larger non-offset circle hooks and/or 18/0 or larger circle hooks with an offset not to exceed 10 degrees. Only whole finfish and squid baits could be possessed and/or utilized with the allowable hooks outside of the NED. The 2004 rule also re-opened the NED to PLL fishing for Atlantic HMS, but required vessels with PLL gear onboard in that area, at all times, to possess and/or use only 18/0 or larger circle hooks with an offset not to exceed 10 degrees. Within the NED, only whole mackerel and squid baits may be possessed and/or utilized with allowable hooks. Finally, NMFS required specific sea turtle release equipment to be possessed on board PLL vessels and adherence to specific handling and release techniques for sea turtles. The sea turtle handling and release placards and protocols were revised, and a video showing proper sea turtle handling techniques was mailed to all PLL vessel owners. The placards, protocols, and video were made available in English, Spanish, and Vietnamese.

In 2006, NMFS merged the FMP for Atlantic Tunas, Swordfish, and Sharks and the Atlantic Billfish FMP into one Consolidated HMS FMP. The final rule implementing the 2006 Consolidated HMS FMP (71 FR 58058, Oct. 2, 2006) contained several management measures applicable to the PLL fishery. These included: (1) Mandatory workshops for the safe release, disentanglement, and identification of protected resources for PLL vessel owners and operators; (2) implementation of the Madison-Swanson and Steamboat Lumps Marine Reserves to complement Gulf of Mexico Fishery Management Council regulations; and, (3) a clarification of the definitions of bottom longline and PLL gear based upon the species composition of the catch onboard or offloaded.

NMFS also thoroughly considered and analyzed time/area closures as a means to minimize bycatch and bycatch mortality in HMS fisheries in the Environmental Impact Statement that supported the Consolidated HMS FMP. The EIS analyzed the ecological, economic, and social impacts of 12 alternatives and subalternatives for potential PLL closures in the Atlantic and GOM on blue and white marlin, sailfish, spearfish, BFT, pelagic and large coastal sharks, and leatherback, loggerhead, and other sea turtles as part of the management measures considered to reduce bycatch. To evaluate the potential overall conservation benefits of each closure scenario, NMFS analyzed the impacts of the redistribution of fishing effort under various redistribution schemes (e.g., fleet-wide redistribution of effort into all open areas or redistribution of effort only to open areas of the GOM). Redistribution of effort refers to fishing effort that is, or may be, applied in another location due to a closure. Previous research and requests for closures of portions of the GOM to protect BFT did not consider redistribution of effort when proposing a closure. These requests included research that presumed fishermen would simply stop fishing altogether if they could not fish in the closed areas. NMFS analyses were the only analyses at the time that modeled the potential for redistribution of effort related to closures in the GOM.

NMFS found that with some level of redistributed effort, no one closure, or combination of closures, would have reduced bycatch of all of the species considered. In addition to implementing complementary HMS management measures in the Madison-Swanson and Steamboat Lumps Marine Reserves, the final 2006 Consolidated HMS FMP established criteria to consider when assessing possible new time/area closures or making modifications to existing time/area closures. Criteria that would be considered may include, but are not limited to, the following: Any ESA-related issues, concerns, recommendations, or requirements including those in applicable Biological Opinions; bycatch rates of protected species, prohibited HMS, or non-target species both within the specified or potential closure area(s) and throughout the fishery; bycatch rates and post-release mortality rates of bycatch species associated with different gear types; applicable research; new or updated landings; bycatch and fishing effort data; social and economic impacts; and the practicability of implementing new or modified closures, including consistency with the FMP, Magnuson-Stevens Act, ATCA, and other applicable law. If the species is an ICCAT-managed species, NMFS would consider the effects of domestic and international fisheries on that species before implementing time/area closures. Other factors that NMFS would consider before implementing time/area closures include, but are not limited to, gear types and the location and timing of a closed area. NMFS would attempt to balance the ecological benefits with economic and social impacts. NMFS would also consider alternatives to closed areas, such as reducing quotas, mandatory gear modifications, or alternative fishing practices such as designated fishing days. Thus, before the implementation of a time/area closure, NMFS would determine that such a closure would be the best option for a given set of management goals, consistent with the FMP, the Magnuson-Stevens Act, and applicable law. Although NMFS decided at the time to not move forward with an HMS PLL closure in the GOM given the implications associated with redistribution of fishing effort, it stated its intent to continue to pursue other alternatives to reduce bycatch in the GOM, especially for BFT.

Since 2006, there have been additional regulatory and management actions potentially affecting PLL vessels in the GOM. These include Amendment 1 to the Consolidated HMS FMP (74 FR 28018, June 12, 2009), which revised HMS Essential Fish Habitat and designated a new Habitat Area of Particular Concern (HAPC) for BFT spawning areas in the GOM, and implementation of a small closure to protect reef species in the GOM named the “Edges 40 Fathom Closure” (74 FR 66585, December 16, 2009). There has also been a positive 90-Day Finding on a Petition to List Atlantic Bluefin Tuna as Threatened or Endangered Under the ESA (75 FR 57431, September 21, 2010), although this is a preliminary step in any listing process. With regard to sea turtles, NMFS has recently proposed to list the Northwest Atlantic loggerhead sea turtle as “endangered” under the ESA (75 FR 12598, March 16, 2010).

In the spring of 2007, observer coverage in the GOM was increased to better characterize the interaction of the PLL fleet with BFT on the spawning ground with coverage approaching 100 percent during the spawning season (April to mid-June). In 2010, approximately 50 percent of trips during the BFT spawning season were observed, which provides a reliable estimate of bluefin tuna bycatch. Starting in 2007, the NMFS Engineering and Harvesting Branch of the Southeast Fisheries Science Center (SEFSC), Mississippi Laboratories, began conducting scientific research in consultation and cooperation with the domestic PLL fleet in the GOM to develop and assess the efficacy of new technologies for reducing the bycatch mortality of BFT in the directed YFT fishery. During the first year of the research, experiments were conducted aboard the NOAA research vessel R/V Gandy to collect data on the relative force exerted by BFT and YFT when captured on PLL gear. Treatments of three different breaking strengths of monofilament leader were tested to determine which leader strength would effectively release BFT yet retain YFT. Based on promising results that indicated certain monofilament leaders were capable of releasing BFT of the sizes captured, NOAA researchers began working with hook manufacturers to develop a hook design that has less tensile strength than standard hook designs. Research conducted since has continued to evaluate the efficacy of a weaker 16/0 circle hook in reducing the bycatch of BFT by comparing it to a standard 16/0 circle hook used in the PLL fishery during targeted fishing operations. (See Research Experiment section below.)

Since January 1, 2007, shark limited access and swordfish limited access permit holders who fish with longline or gillnet gear have been required to attend a Protected Species Safe Handling, Release, and Identification Workshop and submit a certificate to NMFS indicating that they have attended a workshop in order to renew their shark and swordfish permits. These mandatory workshops teach longline and gillnet fishermen the required techniques for the safe handling and release of entangled and/or hooked protected species, such as sea turtles, marine mammals, and smalltooth sawfish. The overall goal of the workshops is to provide fishermen with the skills needed to reduce the mortality of protected species to meet the requirements of the 2004 PLL BiOp. Approximately two workshops are held monthly in locations along the Atlantic coast and the GOM. Over 100 workshops have been conducted since 2006.

On April 20, 2010, an explosion and subsequent fire damaged the Deepwater Horizon MC252 oil rig, which capsized and sank approximately 50 miles southeast of Venice, LA. Oil flowed for 86 days into the GOM from a damaged well head on the sea floor. In response to the Deepwater Horizon/BP oil spill, NMFS issued a series of emergency rules (75 FR 24822, May 6, 2010; 75 FR 26679, May 12, 2010; 75 FR 27217, May 14, 2010) closing a portion of the GOM exclusive economic zone (EEZ) to all fishing. The fishery closures ranged in size from 6,817 sq. mi. (<4 percent of the U.S. GOM) on May 2, 2010, to 88,522 sq. mi. (approx. 37 percent of the U.S. GOM) on June 2, 2010. NMFS continues to adjust the spatial dimensions of the fishery closed area as new information becomes available regarding areas affected by oil. Information regarding the current status of the oil spill related fishery closed area may be found at http://sero.nmfs.noaa.gov/ .

ICCAT's SCRS conducted their latest BFT stock assessments in September 2010. The text below (under the headings of “State of the Stock” through “Management Recommendations”) is quoted from the executive summary of the western BFT stock assessment found in the Report of the SCRS, Madrid, Spain, October 4-8, 2010. It is important to note that in its summary text, the SCRS made reference to only a few specific TAC levels and associated probabilities of success for purposes of illustrating the chances of rebuilding the stock (maintaining B above B MSY ) through the rebuilding period and preventing overfishing (maintaining F below F MSY ) around certain thresholds, under the low and high recruitment scenarios. However, SCRS considered and presented a broad range of TACs under the low recruitment, high recruitment, and combined scenarios in “Kobe II matrix” tables that were part of the SCRS report. Note that the SCRS uses the abbreviation “t” for tons; it is equivalent to mt.

At its November 2010 meeting, ICCAT adopted a measure for western Atlantic BFT that, among other things, reduced the TAC from 1,800 mt to 1,750 mt for both the 2011 and 2012 fishing seasons—a 2.8 percent reduction overall. The Kobe II matrices show that, under the low recruitment scenario, the new TAC has a 99 percent probability of maintaining the fishing mortality of western bluefin tuna for 2011 and 2012 below the fishing mortality associated with MSY and a 95 percent probability of maintaining the stock above the biomass that will support MSY (B MSY ) through the end of the rebuilding period, i.e., by 2019. Under the combined scenario, the TAC has a 54 percent probability of ending overfishing within 2 years and a 48 percent probability of rebuilding the stock to the B MSY level by the end of the rebuilding period. Under the high recruitment scenario, the TAC has an 8 percent probability of ending overfishing within two years and a zero chance of rebuilding the stock to the B MSY level by the end of the rebuilding period. Under any scenario, the agreed TAC is expected to support continued stock growth if compliance with agreed rules remains strong.

The 2010 ICCAT western Atlantic BFT recommendation is scheduled to enter into force in June 2011. NMFS plans to implement the U.S. portion of the TAC in the spring of 2011 via proposed and final rulemaking to set quotas for the domestic fishing categories.

Data are not available, at this time, to demonstrate any specific effects of the Deepwater Horizon/BP oil spill on the BFT, YFT, swordfish, or other HMS resources. However, it is possible that the oil spill could have impacts on fish eggs and larval stages of species (including BFT, YFT, swordfish, and other highly migratory species that occur in the GOM). Oil from the spill has dispersed on the surface as well as deep within the water column, but in the time since the well head was capped, oil has disappeared from some areas. BFT spawn from April to mid-June. Oil that was present in surface waters could have affected the survival of eggs and larvae and affected recruitment. Effects on the physical environment such as low oxygen and the inter-related effects that culminate and magnify through the food web could lead to impacts on the ability of larvae and post-larvae to survive, even if they never encountered oil. In addition, effects of oil exposure may not always be lethal, but can create sub-lethal effects on the eggs, larva, and early life stages of fish. There is the potential that the stressors can be additive, and each stressor may increase the susceptibility to the harmful effects of the other. Conversely, juvenile BFT, YFT, swordfish, and most other HMS are pelagic in nature, have a fast growth rate, and quickly gain the ability to swim over long distances. This capability may allow juvenile HMS to avoid areas of concentrated oil. In addition, there would be less potential impacts to HMS juveniles and adults if oil remains on the surface, continues to wash ashore, or continues to decompose to non-lethal levels.

As described above, the GOM PLL fishery targets YFT and, to a lesser extent, swordfish. These species, along with BFT and others, are managed by ICCAT. The ICCAT SCRS conducted a full stock assessment for YFT in 2008, applying both an age-structured model and a non-equilibrium production model to the available catch data through 2006. In summary, 2006 catches were estimated to be well below MSY levels, stock biomass was estimated to be near the Convention Objective (near B MSY or the level of biomass that can sustain MSY) and fishing mortality rates somewhat below F MSY . Trends through 2006 indicate declining effective effort and some recovery of stock levels. However, when the uncertainty around the point estimates from both models is taken into account, there was still about a 60 percent chance that stock status was not consistent with Convention Objectives.

The current SCRS results for swordfish indicate that the stock is at or above B MSY . The estimated relative biomass trend shows a consistent increase since 2000. The relative trend in fishing mortality shows that the level of fishing peaked in 1995, followed by a decrease until 2002, followed by small increase in the 2003-2005 period and downward trend since then. Fishing mortality has been below F MSY since 2005. The results suggest that there is a greater than 50 percent probability that the stock is at or above B MSY , and thus ICCAT's rebuilding objective has been achieved. However, it is important to note that, since 2003, the catches have been below the TAC, greatly increasing the chances for a fast recovery. Overall, the stock was estimated to be somewhat less productive than the previous assessment, with the intrinsic rate of increase, r, estimated at 0.44 compared to 0.49 in 2006.

The PLL fishery for Atlantic HMS primarily targets swordfish, YFT, and bigeye tuna in various areas and seasons. Secondary target species include dolphin (fish), albacore tuna, and, to a lesser degree, sharks. Although PLL gear can be modified (e.g., depth of set, hook type, hook size, bait, etc. ) to target swordfish, tunas, or sharks, it is generally a multi-species fishery. These vessel operators are opportunistic, switching gear style and making subtle changes to target the fish providing the most economic benefit for each individual trip. PLL gear sometimes attracts and hooks non-target finfish with little or no commercial value, as well as species that cannot be legally retained by commercial fishermen, such as billfish. PLL gear may also interact with protected species such as marine mammals, sea turtles, and seabirds. Thus, this gear has been classified as a Category I fishery with respect to the Marine Mammal Protection Act (MMPA). Any species (or undersized catch of permitted species) that cannot be legally landed is required to be released, regardless of whether the catch is dead or alive.

The U.S. PLL fishery has historically been comprised of five relatively distinct segments with different fishing practices and strategies. These segments are: (1) The GOM YFT fishery; (2) the South Atlantic-Florida east coast to Cape Hatteras swordfish fishery, although historical catches have decreased because of the Florida East Coast and Charleston Bump time/area closures; (3) the Mid-Atlantic and New England swordfish and bigeye tuna fishery; (4) the U.S. distant water swordfish fishery; and, (5) the Caribbean Islands tuna and swordfish fishery. In addition to geographical area, these segments have historically differed by percentage of various target and non-target species, gear characteristics, and deployment techniques. Some vessels fish in more than one fishery segment during the course of a year. Due to the various changes in the fishery ( i.e., regulations, operating costs, market conditions, species availability, etc. ) the fishing practices and strategies of these different segments may change over time.

GOM vessels primarily target YFT year-round; however, a handful of these vessels directly target swordfish, either seasonally or year-round. Longline fishing vessels that target YFT in the GOM also catch and sell dolphin (fish), swordfish, other tunas, and sharks. During YFT fishing, few swordfish are captured incidentally. Many of these vessels participate in other GOM fisheries (targeting shrimp, shark, and snapper/grouper) during allowed seasons. Home ports for this fishery include, but are not limited to, Madiera Beach, FL; Panama City, FL; Dulac, LA; and Venice, LA.

NMFS, Engineering and Harvesting Branch of the Southeast Fisheries Science Center (SEFSC), Mississippi Laboratories, worked with the GOM PLL fleet from 2007-2010, to collaboratively develop technology to address a growing concern about bycatch mortality of spawning BFT. Research efforts focused on how to take advantage of the difference in the relative larger size of spawning bluefin as compared to the target species, YFT. NMFS researchers worked with hook manufacturers to develop a hook design that has less tensile strength than standard hook designs. Research conducted in 2008-2010 evaluated the efficacy of a weaker 16/0 circle hook in reducing the bycatch of BFT by comparing it to a standard 16/0 circle hook used in the PLL fishery.

The control treatment was an industry standard Mustad 16/0 circle hook (model 39960D) with 0° of offset, constructed of 4.0 mm steel wire with Duratin coating. The experimental treatment was a custom made Mustad 16/0 circle hook (model 39988D) with 0° of offset, constructed from 3.65 mm steel wire with Duratin coating. Experimental hooks and standard 16/0 circle hooks were alternated on the longline during sets. Other than the experimental design requirements, captains were allowed to fish normally and chose the location of fishing, length of trips, total number of hooks fished, etc. All vessels participating in the experiment carried NMFS trained observers who collected fishery data as described by the SEFSC PLL Observer Program. Over the course of the study from 2008-10, data was collected from six vessels completing 34 trips with 311 PLL sets deploying 198,606 total hooks (99,303 of each hook type).

A total of 33 BFT were caught during the experiment, of which 10 were caught on the experimental hook for a statistically significant reduction of 56.5 percent compared to the control hook (95 percent confidence interval (CI) = 8.7 percent to 79.3 percent). Vessels landed a total of 2,065 YFT, of which 1,016 were caught on the experimental hook for a reduction of 3.2 percent (95 percent CI = 11.2 percent to −5.6 percent; a negative number denotes an increase), which was not statistically significant. Not all YFT caught are retained for sale mainly due to some fish not meeting the minimum size limit. The difference in YFT retained for sale between the control and experimental hooks was analyzed and showed a reduction of 7.0 percent (95 percent CI = 15.6 percent to −2.5 percent), which was not statistically significant.

The total swordfish catch per unit effort (CPUE) (number of fish per 1,000 hooks) for the control and experimental hooks (1.21 and 1.15, respectively) were not significantly different. The difference in the catch of swordfish retained for sale (0.34 control and 0.20 experimental) was not statistically significant. The difference in CPUEs for the control and experimental hooks for wahoo (1.48 and 1.09 respectively) was statically significant. The difference in CPUEs for dolphin fish (4.25 and 3.93 respectively) and escolar (1.81 and 1.78 respectively) were not significantly different. A total of 96 white marlin and roundscale spearfish combined were caught and discarded with 38 and 58 fish caught on the control and experimental hook, respectively, for an increase of 52.7 percent that was marginally significant.

The data presented suggest a weaker circle hook design may have the potential to mitigate bycatch mortality of BFT with minimal reduction in the retention of the YFT target catch and some potential reduction in swordfish retained. The evaluation of the condition of hooks that caught BFT shows that BFT interaction with control hooks (the currently required hook/industry standard) commonly results in deformation of the hook. These observations suggest some portion of the 53 straightened control hooks that resulted in fish escapement were likely due to BFT interactions.

There are several factors that contribute to the application of the level of force necessary to straighten a hook during the interactions with animals. It would be difficult to assess all of these factors. This research has shown that YFT weight is a contributing factor. It is reasonable to suspect the same is true for BFT. Other factors which may influence the level of force exerted on a hook by an animal during interaction include: Water temperature, currents, fishing depth, hooks between floats, distance to the nearest float, interaction with other animals on the longline, and vessel hauling practices.

The retention rate of YFT with the experimental hook was highly variable among the vessels participating in the experiment. The two vessels with the highest reduction of YFT also had the highest rate of fish escapement due to straightened experimental hooks. Attempts were made to standardize the gear configurations as much as possible during this fishery dependant research. Therefore, it is probable that variability in YFT retention rates was a result of the variability in hauling practices. NMFS anticipates that this variability in the performance of the new hook design will be reduced over time as fishermen become more familiar with fishing with the weak hook. As with any new conservation technology, minor adjustments in fishing practices are often needed in order to optimize the gear performance. However, the majority of the vessels involved with the study continue to use the new hook design. Additional vessels, not involved in the study, have purchased the experimental hook for use. Additional research will improve the statistical precision and confidence of the results and, if conducted on a year round basis, will help evaluate possible temporal effects of the weak hook on the target catch.

In this proposed rule, NMFS proposes to require all PLL vessels fishing in the GOM to use weak hooks. This alternative would limit vessel operators participating in the Atlantic HMS PLL fishery in the GOM, at all times, to possess and/or use only weak hooks immediately upon the effective date of the action. A weak hook would be defined as a circle hook, meeting current size and offset restrictions, constructed of only round wire stock that is no larger than 3.65 mm in diameter. All other existing requirements for the GOM PLL fishery would remain in effect including, but not limited to: Existing hook size and shape requirements; existing bait requirements; existing time/area closures and live bait restrictions in the GOM PLL fishery; and existing possession and use requirements for bycatch mitigation gear, as well as sea turtle handling and release training and guidelines currently specified by NMFS. The fishery would continue to comply with all requirements of existing biological opinions.

The agency would conduct simultaneously an outreach program and work with dealers and vessel operators to educate and ensure the requirement is understood and implemented. Research programs would continue to determine the effect on bycatch and discard mortality of BFT and other bycatch, as well as target catches.

Assuming similar reductions from gear modifications as reflected in the GOM PLL BFT mitigation research, implementation of weak hooks could reduce the bycatch of BFT in the GOM PLL fishery by approximately 56.5 percent. This would likely result in a reduction in the number of BFT caught in the GOM from an annual average of 285 individual fish from 2006-2009 to approximately 124 individual fish. Reductions in interactions of this magnitude could have positive impacts on the BFT population by minimizing bycatch of spawning BFT, and thus bycatch mortality due to incidental interactions with PLL gear. Post-release mortality is expected to be reduced because BFT straighten the weak hooks relatively quickly after being caught and likely do not incur as high a level of metabolic stress as when the fish stay on the hook until being retrieved upon haul-back of the gear. Due to the fact that BFT have the highest level of energy available at the moment when they become hooked, NMFS suspects that escapement occurs soon after hook-up. Years of observer data and research fishing have shown that most BFT are dead upon haul-back of PLL gear set in the GOM. A reduction in the number of BFT captured incidentally by PLL operations in the GOM could possibly save 124 spawning BFT annually. Some positive ecological impacts may be realized in the near future if the weak hook is implemented prior to the 2011 spawning season. Rapid implementation could aid in the survival of the large 2003 year class identified by the ICCAT SCRS as warranting particular management attention. Enhanced survival of spawners from this year class may improve spawning success and size of subsequent year classes, ultimately increasing stock biomass.

While research results indicated a reduction in BFT bycatch, the results indicated a 52.7 percent increase in bycatch of white marlin and roundscale spearfish, combined, with the use of weak hooks as compared to the catch rate of the standard circle hook currently used by the GOM PLL fleet. The weak hook research indicated an increase of 52.7 percent in white marlin/roundscale spearfish catch, and this analysis assumes that the increase in catch would be proportionally the same for live discards and dead discards, thus representing a 52.7 percent increase in each. For the purposes of this analysis, NMFS assumes a 52.7 percent increase in dead discards. White marlin are considered to be overfished, although much uncertainty exists about the current population status due in part to confusion of white marlin with roundscale spearfish in various databases. Roundscale spearfish were recently recognized as a distinct, separate species (75 FR 57698; September 22, 2010). The status of roundscale spearfish stocks is unknown. NMFS determined that listing white marlin as endangered or threatened under the ESA was not warranted in both 2002 and 2008.

According to logbook data, the average annual bycatch of white marlin in the GOM PLL fishery from 2006-2009 was 299 individual fish. With weak hook use in the GOM, the expected catch of white marlin in the GOM PLL fishery could increase by 158 to approximately 457 individual white marlin, annually. Due to the difficulty of distinguishing roundscale spearfish from white marlin, it is likely that some roundscale spearfish are included in the reporting of white marlin catches. Therefore, the estimate of additional white marlin catch would likely be a combination of white marlin and roundscale spearfish.

According to observer data, white marlin dead discards in the GOM PLL fishery in 2009 were 13,200 lbs, which equates to 275 individual fish (using the 2008 average white marlin dead discard weight of 48 lbs). NMFS fishery observers are trained to distinguish white marlin from roundscale spearfish; therefore, it is likely that roundscale spearfish are not included in the white marlin dead discard data for 2009. If white marlin dead discards increase by 52.7 percent (as found during research fishing), an additional 144 white marlin could be discarded dead. There may also be some additional roundscale spearfish dead discards that could occur with the use of weak hooks; however, NMFS is unable to provide an estimate at this time. NMFS found no significant difference in bycatch of blue marlin or sailfish while using industry standard circle hooks and the experimental weak hook on PLL gear in the GOM.

With regard to target species and other marketable catch, data from the GOM PLL BFT mitigation research indicate that the experimental weak hook facilitates the release of BFT but also decreases YFT and swordfish catch by 3.2 percent and 5.0 percent, respectively. The reduction in catch for YFT and swordfish was not statistically significant. Further, use of the weak hook may decrease the number of YFT and swordfish retained for sale (meaning fish equal to or larger than the minimum size) by 7.0 percent and 41.2 percent, respectively. The reductions in fish retained for sale were not statistically significant. With use of the weak hook, the number of wahoo caught may decrease by 26.6 percent. The results for pelagic and large coastal sharks were not significant; although, observations were mixed with reduction in catch observed for some species and increases in catch for others. These uncertain results are likely due to low numbers of observations during the experiment. The results of the weak hook study for species with low sample size (<10 individuals) cannot be relied upon to determine the effects of using the experimental hook.

With the use of weak hooks in the GOM PLL fishery, potential decreases in YFT, swordfish, and wahoo catches, by number of fish, may have positive ecological benefits for all three species by leaving more sexually mature individuals in the ecosystem. Decreased YFT and swordfish catches may have negative ecological impacts for species known to interact with PLL gear if an increase in fishing effort occurs in order to offset reduced YFT catches. Increased effort may result in an increase in bycatch and bycatch mortality of non-target species, including billfish and protected resources. With the use of weak hooks, potential decreases in lancetfish bycatch by 14.8 percent (which was statistically significant) may have positive ecological benefits for lancetfish by leaving more fish in the ecosystem to reproduce.

A reduction in catch of some pelagic and large coastal sharks did occur with the experimental hook; although only a few observations were recorded and the reduction was not statistically significant. If some reduction in catch of pelagic or large coastal sharks actually occurs with the use of weak hooks, some unquantifiable positive ecological benefits for pelagic and large coastal sharks may occur due to the reduction in marketable sharks retained.

The use of weak hooks in the GOM PLL fishery would continue to provide positive ecological impacts, similar to the existing required standard circle hook, by facilitating the removal of fishing gear, which is expected to increase post-hooking survival of species caught incidentally to target fishing operations, including protected species. Additionally, anecdotal reports from scientists that conducted the weak hook study indicated that the weak hook was easier to dislodge from incidentally captured/foul hooked leatherback sea turtles than the currently required standard circle hook.

Magnuson-Stevens Act National Standard 9 was identified in the 2006 Consolidated HMS FMP along with National Standard 1 as priority management goals for HMS fisheries, particularly the Atlantic PLL fishery. National Standard 9 states that “conservation and management measures shall, to the extent practicable, (A) minimize bycatch and (B) to the extent bycatch cannot be avoided minimize the mortality of such bycatch.” National Standard 9 applies to all species and fisheries. National Standard 1 states that “Conservation and management measures shall prevent overfishing while achieving, on a continuing basis, the optimum yield from each fishery for the United States fishing industry. The 2006 HMS FMP analysis of alternatives for time area closures and combinations of closures showed higher bycatch levels for some species and lower for others. NMFS did not prefer any new closures in the 2006 Consolidated HMS FMP, except the complementary measures in the Madison-Swanson and Steamboat Lumps Marine Reserves, and did not modify any closures at that time primarily because no closure alternative or combination of alternatives would substantially reduce the bycatch of all species considered, assuming redistribution of effort, and address other goals of the FMP, including minimizing any negative impacts.

This proposed action is expected to reduce BFT bycatch. The recent NMFS weak hook study was conducted in response to concerns for spawning age BFT PLL post release survivability in the GOM and provides information that may help to reduce bycatch and bycatch mortality of spawning age BFT. Preliminary results of the study showed a reduction, no change, or inconclusive results in the bycatch of species caught on PLL gear in the GOM except for an increase in bycatch of white marlin and roundscale spearfish. NMFS does not believe that this increase is likely to have population or ecosystem effects for those species because the predicted increase of 144 white marlin (or 1.05 mt in 2009 at 48 lb per fish) dead discards represents less than 0.8 percent of the total amount of international white marlin catch (which includes recreational landings and commercial dead discards) in the North Atlantic (406 mt in 2009). Due to misidentification of roundscale spearfish as white marlin, the total of white marlin international catch also includes some roundscale spearfish and, as such, indicates that any potential increase in roundscale spearfish that might occur in the GOM PLL fishery as a result of this proposed action should be very small in relation. In addition, NMFS already has comprehensive regulations in place to conserve these species in its domestic fisheries. Under current regulations, PLL vessels are not allowed to retain white marlin/roundscale spearfish, and any that are captured must be released alive or discarded if dead. Additionally, PLL vessels are currently required to possess and use protected species safe handling and release gears and techniques that aid in releasing hooked animals, including white marlin, and maximize post-release survival without removing the fish from the water. Most white marlin/roundscale spearfish that are hooked are released alive. Beyond PLL vessels, current regulations also include a ban on retention on all commercial fishing vessels, observer coverage and mandatory reporting on commercial fishing vessels, a recreational size limit, and an annual 250 marlin landings limit in recreational fisheries.

If this proposed action was finalized, NMFS would continue research with weak hook technology and closely monitor white marlin and roundscale spearfish catch through observer coverage in the fishery. Should the increased catches of white marlin and roundscale spearfish continue, NMFS would investigate potential mitigation measures that might be implemented if necessary to reduce the catches and/or reduce the bycatch mortality associated with the catches. Such measures could include adopting a seasonal application of the weak hook, modification or removal of the weak hook requirement or other measures as necessary and appropriate. NMFS would closely monitor fleet activities and catch statistics and consider making management measures adjustments, including use of inseason management authority, should the data warrant. Given the conservation and management measures in place and continued research and monitoring, and taking into account the National Standard 9 Guidelines, NMFS believes that this proposed rule minimizes bycatch and bycatch mortality to the extent practicable.

Implementation of weak hooks in the GOM PLL fishery would be expected to have moderate negative social and economic impacts in the short-term for those vessels able to successfully utilize the weak hook when fishing with PLL for YFT and other species in the GOM and greater temporary negative economic impacts for those vessels that are unable to quickly alter their fishing techniques to successfully utilize the weak hook technology. NMFS gear researchers have found that fishermen participating in research tend to work through a learning curve with new technology and generally improve their performance with a particular gear over time.

As mentioned above, a reduction in catch of some pelagic and large coastal sharks did occur with the experimental hook; although only a few observations were recorded and the reduction was not statistically significant. If some reduction in catch of pelagic or large coastal sharks actually occurs with the weak hook, some unquantifiable negative economic impacts may occur due to the reduction in marketable sharks retained. Conversely, some unquantifiable economic benefits may result if fishing efficiency increases and fishermen lose less fishing time clearing lines and handling large unmarketable sharks. Additionally, fishermen may experience a reduction in economic losses due to damaged or lost fishing gear.

A probability analysis of the potential change in numbers of BFT incidentally caught, but allowed to be retained due to target catch tolerances, showed only a small reduction with the use of the weak hook. Because only a small portion of the BFT caught are available for landing, the 56.5 percent reduction in catch observed with the weak hook design will not likely result in a 56.5 percent reduction in landings. The majority of trips that landed BFT actually caught more than twice as many BFT as they landed. Therefore, for a majority of trips, the new hook design will not affect the opportunity for vessels to land the allowable number of BFT under existing regulations. The probability analysis used observer data from 2009 and 2010, and estimated any changes in landings that might have occurred if the weak hook had been used. There were 68 observed trips in 2009 and 34 trips observed in 2010 during the BFT tuna observer coverage period. The estimates are based on 2009 and 2010 non-experimental data where 320 BFT were caught with 47 landed during observed trips in 2009, and 115 BFT were caught with 12 landed during observed trips in 2010. The maximum number of BFT caught during a trip was 18 and the maximum number of BFT landed from a trip was two. Results show that use of the weak hook is predicted to decrease the number of BFT retained by only 14 percent (i.e., from 59 observed landings to 51 predicted) with the use of weak hooks. This minor reduction in landings would likely result in minimal negative economic impacts.

The use of weak hooks in the GOM PLL fishery is predicted to have indirect positive economic and social impacts to both the PLL fishery and on the targeted BFT fishery. In past years, the PLL fishery has landed and discarded dead BFT substantially in excess of its allocated quota. If landings and discards can be brought more into alignment with FMP sub-quotas, then management actions with likely substantial negative impacts, such as closure of the PLL fishery, may not need to be considered for quota management purposes. Exceeding PLL allocated incidental quotas (landings and dead discards) has also meant that the BFT sub-quotas have had to be reallocated from prior year underage, the reserve, or directed categories with underharvest to ensure the United States does not exceed its total ICCAT allocated quota. In the near future, however, NMFS may not have the same ability to reallocate quota if ICCAT quotas decrease and directed BFT categories fully meet their own individual quota allocations. The anticipated increased availability of adult (and greater than or equal to the commercial minimum size limit of 73 inches curved fork length) BFT as the strong 2003 year class continues to mature increases the likelihood of, not only increased landings from directed fishing categories, but increased incidental interactions with PLL gear as well. Unless incidental BFT catch is brought into alignment with the available BFT incidental PLL quota, it is possible that quota may need to be transferred from directed quota categories resulting in early closures and negative social and economic impacts to these directed BFT fisheries or that the PLL fishery would have to be closed prior to the end of the fishing year.

Comments on this proposed rule may be submitted via http://www.regulations.gov, mail, or fax. Comments may also be submitted at a public hearing ( see Public Hearings and Special Accommodations below). NMFS solicits comments on this proposed rule by February 12, 2011 ( see DATES and ADDRESSES ).

NMFS will hold three public hearings for this proposed rule. The meeting times, dates, and locations follow. All meetings will begin with an opportunity for individuals to receive information and ask questions about the GOM PLL BFT Mitigation Research followed by a public hearing.

1. February 7, 2011, 2 p.m. to 5 p.m. Eastern Standard Time (EST), NOAA Science Center, 1301 East-West Highway, Silver Spring, MD, 20910.

2. February 9, 2011, 5 p.m. to 8 p.m. Central Standard Time (CST), NMFS Panama City Laboratory, 3500 Delwood Beach Road, Panama City, FL, 32408

3. February 10, 2011, 5 p.m. to 8 p.m. CST, Hilton New Orleans Airport Hotel, 901 Airline Drive, Kenner, LA, 70062

An operator-assisted conference call will be held to receive comments from HMS Advisory Panel members on February 8, 2011, from 2 p.m. to 4 p.m. EST (phone number 888-989-6419; participant code 3557004). This will be a conference call to hear comments from HMS Advisory Panel members; however, the public is invited to participate, and this is not an HMS Advisory Panel meeting. Priority will be given to comments from the Advisory Panel and comments from the general public will be heard as time allows.

The hearings will be physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Peter Cooper at (301) 713-2347 at least 7 days prior to the hearing date. The public is reminded that NMFS expects participants at the public hearings to conduct themselves appropriately. At the beginning of each public hearing, a representative of NMFS will explain the ground rules ( e.g., alcohol is prohibited from the hearing room; attendees will be called to give their comments in the order in which they registered to speak; each attendee will have an equal amount of time to speak; and attendees should not interrupt one another). The NMFS representative will attempt to structure the meeting so that all attending members of the public will be able to comment, if they so choose, regardless of the controversial nature of the subject(s). Attendees are expected to respect the ground rules, and, if they do not, they will be asked to leave the hearing.

Pursuant to section 304(b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that the proposed rule is consistent with the 2006 Consolidated HMS FMP and its amendments, other provisions of the MSA, ATCA, and other applicable law, subject to further consideration after public comment.

NMFS prepared an environmental assessment for this rule that discusses the impact on the environment as a result of this rule. In this proposed action, NMFS is considering requiring the use of weak hooks by PLL vessels fishing in the GOM. This measure is meant to provide a new gear technology for PLL vessels to continue routine fishing operations in the GOM on directed fisheries such as YFT while increasing the live release of incidentally caught Atlantic BFT to further stock recovery of this overfished species. A copy of the environmental assessment is available from NMFS ( see ADDRESSES ).

This proposed rule has been determined to be not significant for purposes of Executive Order 12866.

An initial regulatory flexibility analysis (IRFA) was prepared, as required by section 603 of the RFA (RFA). The IRFA describes the economic impact this proposed rule, if adopted, would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained at the beginning of this section in the preamble and in the SUMMARY section of the preamble. A summary of the analysis follows. A copy of this analysis is available from NMFS ( see ADDRESSES ).

In compliance with section 603(b)(1) of the Regulatory Flexibility Act, the purpose of this proposed rulemaking is, consistent with the Magnuson-Stevens Act and the 2006 Consolidated HMS FMP and its amendments, to further BFT stock recovery by increasing live releases of incidentally caught BFT and adding flexibility by providing a new gear technology for PLL vessels to continue routine fishing operations in the GOM.

In compliance with section 603(b)(2) of the Regulatory Flexibility Act, the objectives of this proposed rulemaking are to: (1) Enhance stock rebuilding by increasing BFT spawning potential and subsequent recruitment into the fishery, ( i.e., rapidly implement the proposed action to increase the survival of spawning BFT in 2011 in the GOM particularly the 2003 year class); (2) constrain PLL BFT catch to the incidental BFT quota allocation; (3) allow the PLL fleet to continue to participate in their directed fisheries (e.g., YFT and swordfish) year-round with less risk of fishery interruption due to insufficient incidental quota availability (i.e., minimize negative social and economic impacts to the PLL directed fisheries); (4) reduce the need for BFT quota reallocation from directed fisheries or the Reserve to cover PLL BFT bycatch (i.e., minimize negative and social impacts to BFT directed fisheries); and (5) minimize negative ecological impacts on non-target or protected species.

Section 603(b)(3) requires Federal agencies to provide an estimate of the number of small entities to which the rule would apply. NMFS considers all HMS permit holders to be small entities because they either had average annual receipts less than $4.0 million for fish-harvesting, average annual receipts less than $6.5 million for charter/party boats, 100 or fewer employees for wholesale dealers, or 500 or fewer employees for seafood processors. These are the Small Business Administration (SBA) size standards for defining a small versus large business entity in this industry.

The GOM PLL fishery is comprised of fishermen who hold an Atlantic Tunas Longline, a Swordfish Directed or Incidental Permit, and a Shark Directed or Incidental limited access permit and the related industries including processors, bait houses, and equipment suppliers, all of which NMFS considers to be small entities according to the size standards set by the SBA. The proposed rule would apply to PLL vessels that fish in the GOM. As of October 2010, there were 248 Atlantic tuna longline limited access permit holders. Of these, 136 were registered in states along the coast of the GOM (including all Florida vessels). However, based on logbook records from 2006 to 2009, on average, only 51 PLL vessels were actively operating in the GOM annually, with a high of 55 vessels in 2007 and a low of 47 in 2006 and 2009. During the summer of 2010, preliminary vessel monitoring system information indicated that the number of active PLL vessels in the GOM decreased by more than 79% due to the Deepwater Horizon/BP oil spill and associated fishery closures.

This proposed rule does not contain any new reporting or recordkeeping requirements, but would require a new compliance requirement (5 U.S.C. 603 (b)(4)). Fishing vessels with PLL gear onboard would be required, at all times, in all areas of the GOM open to HMS PLL fishing, to possess onboard and/or use only circle hooks meeting current size and offset restrictions, as well as being constructed of only round wire stock that is no larger than 3.65 mm in diameter. This proposed rule would not conflict, duplicate, or overlap with other relevant Federal rules (5 U.S.C. 603(b)(5)). Fishermen, dealers, and managers in these fisheries must comply with a number of international agreements, domestic laws, and other FMPs. These include, but are not limited to, the Magnuson-Stevens Act, the Atlantic Tunas Convention Act, the High Seas Fishing Compliance Act, the Marine Mammal Protection Act, the Endangered Species Act, the National Environmental Policy Act, the Paperwork Reduction Act, and the Coastal Zone Management Act. NMFS does not believe that the new regulations proposed to be implemented would duplicate, overlap, or conflict with any relevant regulations, Federal or otherwise.

Under section 603(c), agencies are required to describe any alternatives to the proposed rule which accomplish the stated objectives and which minimize any significant economic impacts. These impacts are discussed below and in the Environmental Assessment for the proposed action. Additionally, the Regulatory Flexibility Act (5 U.S.C. 603 (c) (1)-(4)) lists four general categories of significant alternatives that would assist an agency in the development of significant alternatives. These categories of alternatives are: (1) Establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) clarification, consolidation, or simplification of compliance and reporting requirements under the rule for such small entities; (3) use of performance rather than design standards; and, (4) exemptions from coverage of the rule for small entities.

In order to meet the objectives of this proposed rule, consistent with legal obligations, NMFS cannot exempt small entities or change the reporting requirements only for small entities. Thus, there are no alternatives discussed that fall under the first and fourth categories described above. In addition, none of the alternatives considered would result in additional reporting requirements (category two above). Fishing vessels with PLL gear onboard would be required, at all times, in all areas of the GOM open to HMS PLL fishing, to possess onboard and/or use only circle hooks meeting current size and offset restrictions as well as being constructed of only round wire stock that is no larger than 3.65 mm in diameter. NMFS does not know of any performance or design standards that would satisfy the aforementioned objectives of this rulemaking while, concurrently, complying with the Magnuson-Stevens Act. Perhaps there are performance or design standards that could be designed for weak hooks and BFT bycatch reduction, but they are not practical given the current understanding of this new technology.

NMFS considered and analyzed three main alternatives for this proposed rule. The first alternative was the status quo, no action alternative. This alternative would maintain existing hook and bait requirements in the Atlantic PLL fishery in the GOM. The second alternative would require all PLL vessels fishing in GOM to use weak hooks and is the preferred alternative. Finally, the third alternative would consider establishing additional time/area closures in the GOM. Under this alternative, an area of the GOM would be closed to PLL fishing and could extend over the entire GOM or a subarea. Temporal extents of a closure could be timed to the spawning season for BFT in the GOM, April to mid-June, or for shorter or longer time frames ( i.e. , year round). Areal extents of a closure could be restricted to portions of the GOM where particularly high concentrations of spawning BFT have been observed while minimizing inclusion of areas with high directed YFT fishing operations. Adaptive management programs might also be considered with the temporal/spatial extent of the time/area changes based on real-time information on distribution and abundance of target and non-target species as well as the socio-economic needs of the fishery. In addition to these three alternatives, NMFS also considered other options such as prohibition on all retention of BFT in the GOM ( i.e., no incidental retention of BFT allowed) and adjustment of target catch retention limits ( i.e., modify current limits of one BFT per 2,000 lbs of target catch, two BFT per 6,000 lbs and three BFT per 30,000 lbs). As these alternatives either do not reduce mortality of BFT but rather convert discards to landings (or vice versa), or may have substantial negative social and economic impacts and cannot be implemented in short time frames, these alternatives were determined to not meet the objectives of the action and were not considered further.

Alternative 1, the status quo, no action alternative would not result in any additional economic impacts to small entities in the short-term. NMFS does not anticipate a significant change in landings, ex-vessel prices, or operating costs relative to the “status quo” for small entities under this alternative. However, adverse economic impacts in the medium and long-term could result if no action is taken to address the incidental catch of BFT in the GOM PLL fishery. Adverse economic impacts could occur if the longline quota for BFT is exceeded and a partial or total closure of the fishery is implemented.

The preferred alternative, Alternative 2, would require vessels with PLL gear onboard, at all times, in all areas of the GOM open to PLL fishing, to possess onboard and/or use only circle hooks meeting current size and offset restrictions as well as being constructed of only round wire stock that is no larger than 3.65 mm in diameter. This alternative would result in some minor increases in equipment costs for the new hooks, would likely impact vessel operations, and would also potentially impact catch rates and thus potentially reduce vessel revenues.

Alternative 2 would result in moderate positive social and economic benefits if this measure is able to reduce the bycatch of BFT in the GOM sufficiently to allow the PLL fishery to continue operating in the GOM. However, there would likely be some increased economic costs associated with switching to the weak hook.

This alternative would result in some minor increases in equipment costs associated with acquiring the new weak hooks. Direct cost of purchasing weak hooks is anticipated to increase expenses by $.02 per hook. An informal telephone survey of hook suppliers provides a price of approximately $0.34 per hook for 16/0 commercial grade circle hooks and approximately $0.36 per hook for 16/0 circle hooks constructed of 3.65 mm diameter round wire stock. Assuming that an average of 1,600 hooks per vessel are needed initially to equip vessels with enough required hooks for one trip, the compliance cost, on a per vessel basis, would be approximately $576. NMFS intends to explore opportunities to mitigate costs for PLL fishermen with their initial purchase of the required supply of weak hooks once the weak hook gear is finalized as a requirement. Opportunities might include third party sponsorship of a voucher program where eligible PLL vessels that actively fish in the GOM would be eligible for their initial supply of weak hooks. NMFS specifically requests comments about such a potential voucher program.

Hook replacement rates are anticipated to increase with use of the weak hook. Researchers during the GOM PLL BFT mitigation research estimated that requiring the weak hook would result in a 4.41 hooks per 1,000 hooks increase in the rate of hook replacement due to straightened hooks and YFT hook deformation. The researchers anticipated that this rate was an underestimate; however, they estimated the cost of additional hook replacement with the weak hook to be less than $3.00 per 1,000 hooks set. The standard 16/0 circle hooks currently in use will continue to be used in the U.S. Atlantic and inventories of unused standard 16/0 hooks could be sold to vessels fishing Atlantic outside of the GOM.

With regard to PLL vessels fishing in the Atlantic, but outside the GOM, NMFS solicits specific comment on gear stowage procedures that could allow vessels entering or exiting the GOM with hooks not meeting the weak hook requirement. Such stowage procedures would need to allow vessels to transit the GOM while ensuring the enforceability of weak hook requirements.

Alternative 2 would also potentially impact vessel catch rates, and thus potentially reduce vessel revenues. Based on the GOM PLL BFT mitigation research results, catch rates for several commercially important species were found to be lower using the new weak hooks versus the standard 16/0 circle hooks. The researchers found a statistically significant (at the 5 percent level) reduction in the total catch of BFT and wahoo when weak hooks were used compared to conventional circle hooks. The total catch of BFT was reduced 56.5 percent when weak hooks were used in the experiment. This reduction includes both discards and BFT retained for sale. Based on observer reports of the number of BFT discarded versus retained in the GOM, the researchers estimate that the experimental results indicate that the use of weak hooks would result in approximately a 14 percent reduction in BFT retained for sale given the BFT incidental retention limits. The total catch of wahoo using the weak hook was reduced by 26.6 percent.

The research also observed reduction in the number of YFT and swordfish retained for sale. While these results were not statistically significant at the 5 percent level, the reductions in YFT and swordfish retained did have p-values ≤ 0.15. Weak hooks in the experiment resulted in a 7 percent reduction in YFT retained for sale and 41.2 percent reduction in swordfish retained for sale. No other commercially targeted species observed during the research exhibited catch rate differences between weak hooks and conventional circle hooks with p-values of ≤ 0.15. Therefore, given that YFT is often the target catch for PLL trip in the GOM and the heterogeneous nature of fishing vessel operations, this analysis conservatively includes the observed reductions in YFT and swordfish. In addition, NMFS also ran the analysis with just BFT and wahoo which exhibited statistically significant differences in catch at the 5 percent level to help illustrate the range of possible outcomes.

Using vessel logbook catch data, NMFS translated the reductions in catch observed in the research experiment into potential fishery revenue impacts that may result from requiring the use of weak hooks in the GOM. The calculations are detailed in the EA for this proposed rule which is available on request. Based on the research results, the estimated per trip reduction in revenues that would potentially result from requiring the use of weak hooks in the GOM is approximately $2,265.

Based on HMS logbook reports from 2006 to 2009, the average number of PLL trips taken per vessel per year in the GOM is 9.7. Multiplying 9.7 trips per vessel by the estimated $2,265 per trip reduction in catch revenues results in an estimated reduction of $21,974 in commercial fishing revenues per vessel per year in the GOM resulting from switching to weak hooks. Alternatively, if the analysis only considers the statistically significant reductions in catch at the 5 percent level, as used in the research study, the estimated reduction in annual catch revenues per vessel in the GOM for Alternative 2 would be $1,351 (9.7 trips × $139). This lower estimate may also represent the potential improvements in catch rates that may occur over time as fishermen adapt to the new weak hook technology. NMFS does not foresee that the national net benefits and costs would change significantly in the long term as a result of implementation of the proposed action.

Alternative 3 may cause some fishermen to shift effort to fishing areas outside the GOM and there could be changes in the distribution of the fleet with some fishermen possibly exiting the fishery. Predicting fishermen's behavior is difficult, especially as some factors that may determine whether to stay in the fishery, relocate, or leave the fishery are beyond NMFS' control (fuel prices, infrastructure, hurricanes, etc. ). While some fishermen will continue to fish in the remaining open areas of the Atlantic, Caribbean, and Gulf of Mexico, others may be forced to leave the fishery entirely, such as selling their permits and going out of business, as a result of the closure. Changes in fishing patterns may result in fishermen having to travel greater distances to reach more favorable grounds, which would likely result in increased fuel, bait, ice, and crew costs. While there may be a potential increase in travel, this is unlikely to raise significant safety concerns because the fleet is highly mobile. The potential shift in fishing grounds, should it occur, could result in fishermen selecting new ports for offloading. This would likely have negative social and economic consequences for traditional ports of offloading, including processors, dealers, and supply houses, and positive social and economic consequences for any new selected ports of offloading. NMFS conducted a detailed, comprehensive socio-economic analysis for the time/area alternatives considered in the 2006 Consolidated HMS FMP and found that the economic impacts of each of the closures considered may be substantial, ranging in losses of up to several million dollars annually, depending upon the closure and displacement of a significant number of fishing vessels. Since the data analysis conducted in the 2006 Consolidated HMS FMP, several events have affected the GOM including Hurricane Katrina, Hurricane Rita, and the DWH/BP oil spill among other events. These events resulted in negative economic impacts. While these further impacts have occurred, NMFS believes the closure analysis in 2006 still reflects the substantial impacts of the alternatives that are likely to occur. Cumulatively, the impacts of the closures would likely be adverse and greater than in 2006. Additionally, Alternative 3 in this proposed rule doesn't meet all of the objectives of this proposed rule because it doesn't rapidly enhance BFT stock rebuilding by increasing BFT spawning potential and subsequent recruitment into the fishery ( i.e. rapidly implement the proposed action to increase the survival of spawning BFT by spring 2011 in the GOM).

For the reasons set out in the preamble, 50 CFR part 635 is proposed to be amended as follows: