Federal Register Vol. 81, No.11,

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (referred to below as the Bioterrorism Response Act) provides for the regulation of certain biological agents that have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products. The Animal and Plant Health Inspection Service (APHIS) has the primary responsibility for implementing the provisions of the Act within the United States Department of Agriculture (USDA). Veterinary Services (VS) select agents and toxins are those that have been determined to have the potential to pose a severe threat to animal health or animal products. Plant Protection and Quarantine (PPQ) select agents and toxins are those that have the potential to pose a severe threat to plant health or plant products. Overlap select agents and toxins are those that have been determined to pose a severe threat to both human and animal health or to human health and animal products. Overlap select agents are subject to regulation by both APHIS and the Centers for Disease Control and Prevention (CDC), which has the primary responsibility for implementing the provisions of the Bioterrorism Response Act for the Department of Health and Human Services (HHS).

Subtitle B (which is cited as the “Agricultural Bioterrorism Protection Act of 2002” and referred to below as the Act), section 212(a), provides, in part, that the Secretary of Agriculture (the Secretary) must establish by regulation a list of each biological agent and each toxin that the Secretary determines has the potential to pose a severe threat to animal or plant health, or to animal or plant products. Paragraph (a)(2) of section 212 requires the Secretary to review and republish the list every 2 years and to revise the list as necessary. In this document, we are proposing to amend and republish the list of select agents and toxins based on the findings of our fourth biennial review of the list.

In determining whether to include an agent or toxin on the list, the Act requires that the following criteria be considered:

• The effect of exposure to the agent or the toxin on animal and plant health, and on the production and marketability of animal or plant products;

• The pathogenicity of the agent or the toxin and the methods by which the agent or toxin is transferred to animals or plants;

• The availability and effectiveness of pharmacotherapies and prophylaxis to treat and prevent any illness caused by the agent or toxin; and

• Any other criteria that the Secretary considers appropriate to protect animal or plant health, or animal or plant products.

We use the term “select agents and toxins” throughout the preamble of this proposed rule. Unless otherwise specified, the term “select agents and toxins” will refer to all agents or toxins listed by APHIS. When it is necessary to specify the type of select agent or toxin, we will use the following terms: “PPQ select agents and toxins” (for the plant agents and toxins listed in 7 CFR 331.3), “VS select agents and toxins” (for the animal agents and toxins listed in 9 CFR 121.3), or “overlap select agents and toxins” (for the overlap agents and toxins listed in both 9 CFR 121.4 and 42 CFR 73.4).

On February 27, 2015, we published in the Federal Register (80 FR 10627, Docket No. APHIS-2014-0095) an advance notice of proposed rulemaking and request for comments (ANPR) 1 in order to announce our intention to review the select agent list. We solicited comments regarding potential additions and deletions from the list of select agents and toxins for 60 days ending April 28, 2015. We received 20 comments by that date. They were from scientists, scientific organizations, a State government, private individuals, and industry groups. Suggestions in these comments were used in order to inform our discussions on the content of the select agent list.

APHIS's PPQ program convened an interagency working group to review the list of PPQ select agents and toxins and develop recommendations regarding possible changes to that list. Using the four criteria for listing found in the Act, economic crop data, current Federal quarantine notices, and new scientific information, the working group revisited the currently listed PPQ select agents and toxins and evaluated a number of new plant pathogens for inclusion on the list. Based on this review, APHIS is proposing to amend the list of PPQ select agents and toxins listed in 7 CFR 331.3 by removing three PPQ select agents and toxins from the list. Specifically, we are proposing to remove the following:

• Peronosclerospora philippinensis (Peronosclerospora sacchari) and Sclerophthora rayssiae: There are no viable cultures of these corn pathogens currently held in U.S. laboratories, they are difficult to grow or maintain, difficult to keep viable during transport, and would require a large amount of inoculum to infect fields by artificial means due to the fact that they must spread via infected plant material; and

• Phoma glycinicola (formerly Pyrenochaeta glycines): This soybean pathogen's natural distribution is limited to two countries in Africa, it does not spread rapidly in the field, soybean importation pathways into the United States by which the pathogen might enter are limited, and while no U.S. soybean variety is immune to this pathogen, Environmental Protection Agency-approved fungicides are available to treat any infestation.

APHIS' VS program also convened an interagency working group to review the list of VS select agents and toxins and the list of overlap select agents and toxins in 9 CFR part 121 in order to consider changes to the lists. Based on the review, APHIS is proposing to remove three overlap select agents and toxins from the list set out in § 121.4(b):

• Bacillus anthracis (Pasteur strain): Historically, the B. anthracis Pasteur strain has been retained as a select agent to allow for continued oversight of laboratories in which the accidental (or intentional) combination of this strain with the excluded Sterne strain could occur to produce the wild type phenotype B. anthracis de novo. However, a recent study 2 indicates that bacterial transformation of B. subtilis with plasmid DNA is inefficient; indicating that transformation with bacteria such as B. anthracis (e.g., pXO1 into B. anthracis Pasteur strain) would also be inefficient. Given that B. anthracis Pasteur strain does not encode the plasmid which carries the pathogenic toxin genes, analogous to the Sterne strain which was excluded from Select Agent oversight in 2003, we believe there is no potential for high animal mortality rates or for misuse that might result in social or economic disruption. Therefore, we are proposing that the Pasteur strain be removed from the overlap select agent list.

• Brucella abortus and Brucella suis: While both of these organisms have been eradicated from the domestic livestock industry, they are currently endemic in wildlife and feral swine populations in the United States. However, there is an extensive regulatory control program in place for B. abortus in the remaining affected Designated Surveillance Area. APHIS has also recently enacted a national program to control feral swine that will include surveillance and disease monitoring for swine brucellosis. Therefore, we believe the effect of exposure to these agents on animal health and on the production and marketability of animal products is minimized. We are proposing that these two Brucella species be removed from the overlap select agent list. However, Brucella melitensis, as a foreign animal disease agent not currently found in the United States, would be kept as a VS select agent.

Accordingly, CDC will also be proposing a parallel change to its overlap select agent regulations.

We are proposing to make several changes to the regulations, including the addition of provisions to address the inactivation of select agents, provisions addressing biocontainment and biosafety, and clarification of regulatory language concerning security, training, incident response, and records. These changes, which are described in detail below, would increase the usability of the select agent regulations as well as provide for enhanced program oversight.

In 7 CFR 331.1 and 9 CFR 121.1, we are proposing to add definitions for inactivation and kill curve. We believe these definitions are necessary as they are included in the additional biocontainment and biosafety language we are proposing to add to the regulations.

The definition of inactivation would be established as “a method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.” This definition draws a distinction between inactivation for waste treatment and inactivation of regulated material for future purposes such as research. The definition of kill curve would be established as “the results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.”

We are proposing to amend 7 CFR 331.3(d)(2), 9 CFR 121.3(d)(2), and 9 CFR 121.4(d)(2), which currently exclude nonviable select agents or nonfunctional toxins from the requirements of the regulations, in order to clarify our policy that an entity must use a validated method to render a select agent nonviable or regulated nucleic acids non-infectious for future use. This means that the method must be scientifically sound and that it will produce consistent results each time it is used.

We are proposing that inactivation include the use of one of the following: The exact conditions of a commonly accepted method that has been validated as applied (e.g., autoclaving), a published method with adherence to the exact published conditions (i.e., extrapolations or deductions are to be avoided), or in-house methods, only if validation testing includes the specific conditions used and appropriate controls.

We are also proposing that the entity develop a site-specific kill curve in order to define conditions of inactivation for each select agent or regulated nucleic acid. If there are strain-to-strain variations in the resistance of a select agent to the inactivation procedure, then a specific kill curve would have to be developed for each strain that undergoes the inactivation procedure. A new kill curve would have to be created upon any change in procedure or inactivation equipment. In addition, a validated sterility testing protocol would have to be conducted in order to ensure that the inactivation method has rendered a select agent nonviable or regulated nucleic acids non-infectious.

In addition, we are proposing that an entity be required to report any viability of a select agent or infectivity of regulated nucleic acids that can produce infectious forms of any select agent virus that was subjected to a validated inactivation protocol to APHIS or CDC.

We are also proposing to require that an entity review annually, and revise as necessary, the following: (1) The kill curve procedure and results; (2) site-specific standard operating procedures to ensure that select agents or regulated nucleic acids that can produce infectious forms of any select agent virus are inactivated by a safety margin; and (3) the validated sterility testing protocol used to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent viruses non-infectious.

Finally, we are proposing that written records be kept for any select agent that has been rendered nonviable or regulated nucleic acids that have been rendered non-infectious. We are particularly requesting comments regarding whether there are more specific measures available to demonstrate that a select agent has been rendered nonviable, or a regulated infectious nucleic acid has been rendered non-infectious.

We are also proposing to add to 7 CFR 331.3(e), 9 CFR 121.3(e), and 9 CFR 121.4(e) a paragraph stating that an individual or entity may make a written request to the Administrator for reconsideration of a decision denying an exclusion application. The written request for reconsideration would have to state the facts and reasoning upon which the individual or entity relies to show the decision was incorrect. The Administrator would grant or deny the request for reconsideration as promptly as circumstances allow and will state, in writing, the reasons for the decision. This language was included in previous versions of the regulations and was erroneously removed by an earlier rulemaking.

Sections 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 concern conditions under which entities may be exempted from the requirements of the regulations. Paragraph (a) requires that the identification of the agent or toxin be reported to APHIS or CDC. Since select agents and toxins have the potential to pose a severe threat to both human and animal health, to animal health, to plant health, or to animal and plant products, clinical and diagnostic laboratories typically have their initial results confirmed by a registered or certified reference laboratory. We are proposing to require that in addition to notifying APHIS or CDC, the reference laboratory inform the specimen provider upon confirmation of the identification of a select agent or toxin. This change would clarify our expectations regarding communication and notification between the reference laboratory and the specimen provider.

We are also proposing to add language to paragraph (a) in sections 7 CFR 331.5, 9 CFR 121.5, and 9 CFR 121.6 that specifies that entities may be required to report identification of agents or toxins to other appropriate authorities when required by Federal, State, or local law. This language was added to the CDC select agent regulations in a previous rulemaking, but not to the APHIS regulations and this change is necessary in order to achieve uniformity across all regulations associated with the diagnosis and care for individuals infected with a select agent or toxin. Specifically, we are proposing to add provisions that state that we do not regulate material containing select agents or toxins when it is in a patient care setting and is not being collected or otherwise tested or retained, nor do we regulate waste generated during delivery of patient care. However, once delivery of patient care for the select agent or toxin infection has concluded, these specimens would become subject to the requirements of the regulations. If an entity cannot meet these requirements, then the material may be transferred to another entity according to the select agent regulations or destroyed using an approved method. The decision to retain, transfer, or destroy any specimens must be made within 7 calendar days of the conclusion of patient care. These requirements would be set out in new paragraphs 9 CFR 121.3(d)(4) and 9 CFR 121.4(d)(4).

The regulations in 7 CFR 331.7 and 9 CFR 121.7 set out registration requirements for those entities that wish to work with select agents and toxins and stipulates the individuals within those entities that must undergo a security risk assessment by the Attorney General.

We are proposing to state that an entity registered to possess, use, or transfer a select agent or toxin would have to meet the requirements of the regulations for those select agents and toxins listed on the entity's official registration regardless of whether the entity is in possession of those select agents or toxins and without regard to the amount of select agents or toxins in the entity's possession. This change would serve to codify existing policy and would be added as a new paragraph (b).

The regulations in 7 CFR 331.9 and 9 CFR 121.9 set out requirements for entities requesting to work with select agents and toxins to designate a responsible official, who ensures that the entity continues to meet the requirements of the regulations.

Paragraph (a)(6) requires the responsible official to ensure that annual inspections are conducted for each location where select agents or toxins are stored or used in order to determine compliance with the regulations. The responsible official also must document the results of each inspection and identify and address any deficiencies.

We are proposing to require that any corrections of deficiencies found must also be documented. This change is necessary to improve recordkeeping practices and to provide a more complete account of facility containment and security procedures. We are also proposing to replace the word “laboratory” with the phrase “registered space.” This terminology is more accurate, as registered spaces are not always laboratories.

We are also proposing to add a new paragraph (a)(7), which would require the entity's responsible official to provide contact information for the USDA or HHS Office of Inspector General Hotline, so that employees and other individuals may anonymously report any containment or security concerns they may have. Although the select agent program has established a whistleblower portal on its Web site, there is currently no requirement for employees at registered entities to be made aware of its existence or how to use it. Adding this requirement would allow for increased worker involvement in biosafety/biocontainment and security programs at registered entities and may also enhance the quality of Federal oversight in this area.

We are proposing to amend the regulations in 7 CFR 331.10 and 9 CFR 121.10. These regulations establish parameters for restricting access to select agents and toxins and the process by which individuals may be approved for access to select agents and toxins after the completion of a security risk assessment by the Attorney General.

Paragraph (e) states that a person with valid approval from the HHS Secretary or Administrator to have access to select agents or toxins may request, through his or her responsible official, that the HHS Secretary or APHIS Administrator provide their approved access status to another registered individual or entity for a specified period of time. We are proposing to also require that the responsible official at the visiting person's home entity notify the host entity if that person's approved access to select agents or toxins has been terminated. This would ensure that an individual whose permissions have been terminated would not be allowed further access to select agents and toxins.

The regulations require registered entities to develop and implement a number of plans in order to ensure the safety and security of the select agents they handle. These are:

• A security plan, as described by the regulations in 7 CFR 331.11 and 9 CFR 121.11, that provides for measures sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release;

• A biocontainment plan, in the case of PPQ select agents, or a biosafety plan, in the case of VS and overlap select agents, as described in the regulations in 7 CFR 331.12 and 9 CFR 121.12, that provides for measures sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards); and

• An incident response plan, as described in the regulations in 7 CFR 331.14 and 9 CFR 121.14, that provides for measures that the registered entity will implement in the event of theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin.

All of these plans require annual review and revision as necessary. Drills or exercises must also be conducted at least annually to test and evaluate the effectiveness of the plans. The plans must be reviewed and revised, as necessary, after any drill or exercise and after any incident. We are proposing to require that these drills or exercises be documented to include how the drill or exercise tested and evaluated the plan, any problems identified, any corrective action taken, and the names of the individuals who participated in the drill or exercise. This will provide a more thorough accounting of required activities as well as increasing the efficacy of the plans via testing and entity-directed improvements. We are proposing to add these requirements to 7 CFR 331.11(h), 331.12(e), 331.14(f), 9 CFR 121.11(h), 121.12(e), and 121.14(f).

We are also proposing to add a requirement that the biocontainment, biosafety, and incident response plans be submitted for initial registration, renewal of registration, or when requested. These additions would be located in 7 CFR 331.12(a), 331.14(a), 9 CFR 121.12(a), and 121.14(a). This change is necessary in order to bring the requirements for these plans in line with existing requirements for the security plan.

Details of the changes we are proposing to the security, biosecurity, and biosafety plans individually may be found below.

Paragraph (c)(5) of 7 CFR 331.11 and 9 CFR 121.11 requires that the security plan describe procedures for addressing loss or compromise of keys, passwords, combinations, etc. and protocols for changing access numbers or locks following staff changes. We are proposing to add keycards to that list as they are commonly used. We are also proposing to use the term “access permissions” instead of the term “access numbers,” as it covers a broader range of topics.

We are also proposing to add a new paragraph (c)(11) to the regulations in 7 CFR 331.11 and 9 CFR 121.11. This would require that the security plan contain a description of how the entity authorizes the means of entry into areas where select agents or toxins are stored or used, which would include a description of all centralized access control management systems (e.g., keycards) and/or mechanical key management. This requirement would allow us to directly ascertain the way in which entities allow individuals entry to areas containing select agents and toxins and potentially identify any weaknesses in that process.

In the same sections, paragraphs (d)(7)(i) through (d)(7)(v) encompass a list of activities that individuals with access approval from the Administrator or the HHS Secretary must immediately report to the responsible official. We are proposing to add a new paragraph (d)(7)(vi) to require that the responsible official must be notified of any loss of computer, hard drive, or other data storage device containing information that can be used to gain access to select agents or toxins. Such notification will facilitate notification of the Federal Bureau of Investigation if deemed necessary by the responsible official as the loss of such equipment may be criminal in nature.

Paragraph (a) of 7 CFR 331.12 and 9 CFR 121.12 requires that the biocontainment or biosafety plan contain sufficient information and documentation to describe the biosafety and containment procedures for each select agent or toxin that the registered entity will possess. The plan must also include a description of the biosafety and containment procedures for any animals (including arthropods) or plants intentionally or accidentally exposed to or infected with a select agent. We are proposing to additionally require that laboratory-specific biocontainment and/or biosafety manuals must be accessible to individuals working in those laboratories. This change would help to foster an enhanced culture of responsibility by ensuring that appropriate biocontainment and/or biosafety resources are available to all staff with access to select agents and toxins within a select agent laboratory.

In the aftermath of recent biosafety incidents involving an unintentional release of potentially viable anthrax within the CDC's Roybal Campus, in Atlanta, GA, and the inadvertent cross-contamination and shipment of a laboratory specimen of low-pathogenic avian influenza virus with the VS select agent highly pathogenic avian influenza virus, we believe that the biocontainment and biosafety plans should be designed according to a site-specific risk assessment in accordance with the risk posed by a select agent or toxin. Therefore, we are proposing to add specific provisions to the biocontainment and biosafety plans that would require completion of a written risk assessment for each procedure. This risk assessment would have to include the following elements: A description of the safeguards in place to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; decontamination procedures; waste management procedures; and procedures for handling select agents and toxins in the same spaces as non-select agents and toxins in order to prevent unintentional cross-contamination.

We are specifically requesting comments regarding any specific biocontainment or biosafety measures to prevent laboratory acquired infections or accidental or intentional release of the select agents and toxins from an entity into the community.

Finally, paragraph (c)(2) of 9 CFR 121.12 requires that entities should consider the guidance found in the Occupational Safety and Health Administration regulations in 29 CFR 1910.1200 and 1910.1450. We are proposing to remove this reference as the information in those regulations is also contained in the CDC/National Institutes of Health publication, “Biosafety in Microbiological and Biomedical Laboratories,” which is referenced in paragraph (c)(1) and a second reference is therefore duplicative.

We are proposing to amend the regulations in 7 CFR 331.15 and 9 CFR 121.15, which concern provision of mandatory training for staff and visitors who work in or visit areas where select agents or toxins are handled or stored. We are proposing to require that all individuals who have received approval to have access to select agents and toxins must undergo training regardless of whether they have access to those select agents or toxins. The training would have to be completed within a year of that individual's approval or prior to entry into an area where select agents and toxins are used or stored, whichever occurs first. This change is necessary in order to codify our position regarding which individuals at registered entities are required to receive training.

We are proposing to amend the regulations in 7 CFR 331.16 and 9 CFR 121.16, which concern the transfer of select agents and toxins to a registered entity. Specifically, paragraph (b) states that select agents and toxins may need a permit issued in accordance with 7 CFR part 330 or 9 CFR part 122. We have determined that a permit for the importation or interstate movement of a select agent or toxin listed in 7 CFR 331.3, 9 CFR 121.3, or 121.4 is not required for such importation and/or interstate movement provided that the select agent or toxin is authorized for transfer in accordance with 7 CFR 331.16(b) or 9 CFR 121.16(b).

The regulations in 7 CFR 331.17 and 9 CFR 121.17 concern required recordkeeping procedures for regulated entities as those records relate to select agents and toxins. Paragraph (a)(3)(x) requires that registered entities record the destruction of any toxins by specifically noting the quantity of toxin destroyed, the date of such action, and by whom. However, there is not an equivalent requirement regarding the destruction of select agents. We are proposing to add this requirement in order to ensure consistency with the toxin provisions and ensure proper tracking of select agents from acquisition to destruction. These requirements would be added in a new paragraph (a)(1)(ix).

We are also proposing to require that regulated entities maintain records concerning those select agents that have been rendered nonviable or regulated nucleic acids that have been rendered non-infectious. These records would specifically capture the activities detailed under the heading “Exclusions and Inactivation” above. Such recordkeeping is necessary in order to confirm that an entity has performed the procedures necessary. The select agent program would then have the ability to review those records in order to ensure that the entity is performing all procedures necessary for nonviability or inactivation. The requirements would be added in a new paragraph (a)(8) in 7 CFR 331.17 and 9 CFR 121.17.

We are also proposing to state that any records created that contain information related to an entity's registration or its select agents and toxins must be provided promptly upon request. This requirement would be added to revised paragraph (c). Given the wide variety of entities regulated under the Federal Select Agent Program, the scope of records readily available for program review will enhance the ability of the program to evaluate entity biosafety, biocontainment, security, and incident response programs. Paragraph (c) in both 7 CFR 331.17 and 9 CFR 121.17 would also be revised to specify that such records may include, but are not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs.

Finally, paragraph (b) in both 7 CFR 331.17 and 9 CFR 121.17 requires that regulated entities implement a system to ensure that all records and databases created under this part are accurate, have controlled access, and that their authenticity may be verified. To ensure the accuracy of handwritten records, we are proposing to specify that such records must be legible.

Paragraph (a)(1) in both 7 CFR 331.17 and 9 CFR 121.17 requires entities to maintain an accurate, current inventory for each select agent (including viral genetic elements, recombinant and/or synthetic nucleic acids, and organisms containing recombinant and/or synthetic nucleic acids) held in long-term storage. We continue to receive comments critical of that portion of the regulations. Criticism is typically focused on the belief that a container-based inventory requirement is not a useful mechanism to track inventory of biological agents, since small amounts could be stolen without detection and used to grow larger quantities.

However, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 obliges APHIS and CDC to include a requirement for “the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins” in the regulations. We are therefore soliciting comment regarding what regulatory requirement or requirements should be implemented such that a registered entity could quickly determine whether a select agent had been lost or stolen from long-term storage without that registered entity first having an accurate, current inventory for each select agent held in long-term storage. Additionally, we are soliciting ideas concerning ways in which the current regulations could be amended to address the possibility of theft of a select agent from a container held in long-term storage.

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

In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188) provides for the regulation of certain biological agents and toxins that have the potential to pose a severe threat to human, animal, or plant health, or to animal or plant products. APHIS has completed its fourth biennial review of select agent regulations and is proposing changes that would increase their usability as well as provide for enhanced program oversight. The proposed amendments include provisions to address the inactivation of select agents, provisions addressing biosafety, and clarification of regulatory language concerning security, training, incident response, and records.

The proposed rule would require that entities develop an agent-specific kill curve in order to define conditions of inactivation for each select agent or regulated infectious nucleic acid and maintain written records of having done so.3 Costs of complying with this amendment are therefore expected to be modest.

Currently, there are 291 entities registered with APHIS and CDC. Of these entities, there are 240 registered to possess Tier 1 select agents and toxins, including 78 academic, 29 commercial, 80 State government, 37 Federal government, and 16 private (non-profit) institutions, most of which are considered to be small entities. Based on proposed record keeping and reporting requirements, an additional 10 to 20 hours per year may be required. At an imputed cost of $33.40 per hour (GS-12, step 2), this additional time requirement per entity would cost between $334 and $668 per year, or in total for all registered entities between $80,000 and $160,000.

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

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

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), we have determined that there is burden associated with this action. We will publish a separate document in the Federal Register, announcing our determination of burden and soliciting comments on it.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

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Under the authority of the USGSA (7 U.S.C. 76), GIPSA establishes standards for sunflower seed and other grains regarding kind, class, quality and condition. The sunflower seed standards, established by USDA on September 1, 1984, were last revised in 1988 and appear in the USGSA regulations at 7 CFR 810.1801 through 810.1804. The standards facilitate sunflower seed marketing and define U.S. sunflower seed quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in GIPSA's Grain Inspection Handbook, Book II, Chapter 11, “Sunflower Seed” which also includes standardized procedures for additional quality attributes not used to determine grade, such as moisture content and official criteria. Together, the grading standards and testing procedures allow buyers and sellers to communicate quality requirements, compare sunflower seed quality using equivalent forms of measurement and assist in price discovery.

GIPSA's grading and inspection services are provided through a network of federal, state, and private laboratories that conduct tests to determine the quality and condition of sunflower seed. These tests are conducted in accordance with applicable standards using approved methodologies and can be applied at any point in the marketing chain. Furthermore, the tests yield rapid, reliable and consistent results. In addition, GIPSA-issued certificates describing the quality and condition of graded sunflower seed are accepted as prima facie evidence in all Federal courts. U.S. Standards for Sunflower Seed and the affiliated grading and testing services offered by GIPSA verify that a seller's sunflower seed meets specified requirements, and ensure that customers receive the quality of sunflower seed they purchased.

In order for U.S. standards and grading procedures for sunflower seed to remain relevant, GIPSA is issuing this request for information to invite interested parties to submit comments, ideas, and suggestions on all aspects of the U.S. Standards for Sunflower Seed and inspection procedures.

Under the authority of the USGSA (7 U.S.C. 76), GIPSA establishes standards for oats and other grains regarding kind, class, quality and condition. The oats standards, established by USDA on June 16, 1919, were last revised in 1988 and appear in the USGSA regulations at 7 CFR 810.1001 through 810.1005. The standards facilitate oats marketing and define U.S. oats quality in the domestic and global marketplace. The standards define commonly used industry terms; contain basic principles governing the application of standards, such as the type of sample used for a particular quality analysis; the basis of determination; and specify grades and grade requirements. Official procedures for determining grading factors are provided in GIPSA's Grain Inspection Handbook, Book II, Chapter 7, “Oats” which also includes standardized procedures for additional quality attributes not used to determine grade, such as dockage and moisture content. Together, the grading standards and testing procedures allow buyers and sellers to communicate quality requirements, compare oats quality using equivalent forms of measurement and assist in price discovery.

GIPSA's grading and inspection services are provided through a network of federal, state, and private laboratories that conduct tests to determine the quality and condition of oats. These tests are conducted in accordance with applicable standards using approved methodologies and can be applied at any point in the marketing chain. Furthermore, the tests yield rapid, reliable and consistent results. In addition, GIPSA-issued certificates describing the quality and condition of graded oats are accepted as prima facie evidence in all Federal courts. U.S. Standards for Oats and the affiliated grading and testing services offered by GIPSA verify that a seller's oats meets specified requirements, and ensure that customers receive the quality of oats they purchased.

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

This proposed rule is issued under the Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States (Standards), as amended (7 CFR part 996), as established pursuant to Public Law 107-171, the Farm Security and Rural Investment Act of 2002 (Act). The Standards regulate the quality and handling of domestic and imported peanuts marketed in the United States.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. This action has been designated as a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget (OMB) has waived the review process.

This action has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation would not have substantial and direct effects on Tribal governments and would not have significant Tribal implications.

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect and shall not abrogate nor nullify any other statute, whether State or Federal, dealing with the same subjects as this Act; but is intended that all such statutes shall remain in full force and effect except in so far as they are inconsistent herewith or repugnant hereto (7 U.S.C. 587).

There are no administrative procedures which must be exhausted prior to any judicial challenge to the provisions of this rule.

The Act requires that USDA take several actions with regard to peanuts marketed in the United States. These include ensuring mandatory inspection on all peanuts marketed in the United States; developing and implementing peanut quality and handling requirements; establishing the Board comprised of producers and industry representatives to advise USDA regarding the quality and handling requirements under the Standards; and modifying those quality and handling requirements when needed. USDA is required by the Act to consult with the Board prior to making any changes to the Standards.

Pursuant to the Act, USDA has consulted with Board members in its review of the changes to the Standards included in this proposed rule. This proposed rule invites comments on revisions to the minimum quality, positive lot identification, and reporting and recordkeeping requirements under the Standards. This proposal would also make numerous other changes to the Standards to better reflect current industry practices and to revise outdated language. The Board believes these changes would make additional peanuts available for sale, increase efficiencies, and reduce industry costs. These changes were recommended by the Board at its meetings on June 24, 2015, and November 18, 2015.

The Standards establish minimum incoming and outgoing quality requirements for domestic and imported peanuts marketed in the United States. Mandatory inspection is required to ensure that the quality regulations are met. The Standards also require positive lot identification (PLI) of peanuts so they can be identified and tracked during processing and disposition. Finally, the Standards specify reporting and recordkeeping requirements for handlers and importers.

Sections 996.30 and 996.31 of the Standards outline the incoming and outgoing quality standards, respectively, for peanuts. The incoming standards currently prescribe specific requirements for segregation, moisture content, and foreign material (stones, dirt, sticks, etc.). The outgoing standards include specific requirements for damage, foreign material, and moisture for both shelled and inshell peanuts. The outgoing standards also require peanuts to be positive lot identified and tested and certified as negative for aflatoxin. Both the incoming and outgoing standards require inspection and certification by the Federal-State Inspection Service.

Section 996.15 establishes a definition for PLI. Section 996.31 requires PLI on all peanuts designated for human consumption as part of the outgoing standards. Section 996.40 establishes handling standards for peanuts and includes specifics on how PLI will be used throughout the handling process, from initial identification through the sampling and testing process. Section 996.50 outlines the process for reconditioning failing lots and establishes PLI requirements to track and identify the peanuts throughout the reconditioning process. Section 996.74 outlines the compliance requirements for the Standards and includes penalties for failing to maintain proper PLI.

Sections 996.71 and 996.73 establish the reporting and recordkeeping requirements under the Standards. These sections specify, in part, the reports required and establish what records need to be maintained and for how long.

The Standards were last revised in 2005. In 2014, the American Peanut Shellers Association (APSA) started a review of the current Standards and developed a proposal to revise the Standards to reflect changes in the industry and to make other changes to bring the Standards up to date. These recommended revisions were shared with USDA and industry representatives and were then presented to the Board at its meeting on June 24, 2015. The Board voted to approve the recommendations from APSA in their entirety. In addition, a subcommittee was created to work with USDA to review and recommend any additional conforming changes to the Standards necessary to facilitate the revisions requested by the industry. At a meeting on November 18, 2015, the Board reviewed the modifications and conforming changes from the subcommittee and USDA, and approved them unanimously. Consequently, this proposed rule would make the following recommended changes.

This proposed rule would revise the minimum quality requirements under both the incoming and outgoing standards. The industry originally thought the presence of foreign material in incoming peanuts could promote the growth of aflatoxin. Therefore, a limit on the amount of foreign material in incoming peanuts was established. However, the industry no longer believes there to be a correlation between foreign material and aflatoxin. In addition, due to advances in technology, foreign material is easily removed from incoming peanuts, and handlers are able to remove foreign material from incoming peanuts to a level that is lower than the limit currently specified in the incoming standards. Further, most handlers are setting their own tolerances for the presence of foreign material. Eliminating the maximum amount of foreign material that incoming farmers stock peanuts may contain from the Standards would provide additional flexibility by allowing individual handlers to determine the amount of foreign material they would be willing to accept. As such, this proposal would remove the current limit of 10.49 percent on the amount of foreign material that incoming farmers stock peanuts may contain.

The outgoing quality standards include a table that outlines, in part, requirements for damage, minor defects, foreign material, and moisture. Two of the columns of the table deal with damage and defects. The first of these columns provides the allowance for major damage to unshelled peanuts and kernels, and the second column provides the allowance for minor defects. Currently, the allowance for major damage is 1.5 percent for lots excluding splits and 2 percent for lots of splits. The current allowance for minor defects is 2.5 percent, except for No. 2 Virginia peanuts, for which the allowance for minor defects is 3 percent.

Under the proposal from APSA, the two columns on damage would be merged into one column and would set one overall allowance for damage for unshelled peanuts, cleaned-inshell peanuts, and kernels of 3.5 percent. Over the years, the industry has found that growing practices such as no till farming and modern harvesting practices have increased the amount of damage to individual kernels. In addition, the shift to new peanut varieties that produce larger kernels has impacted the sampling of peanuts for damage. The larger kernels reduce the number of peanuts in the sample such that damaged kernels have a larger impact on the percentage of damage in the sample size. Increasing the allowable damage would allow additional peanuts to meet the Standards and be shipped for human consumption. In addition, relaxing the damage allowance would allow more lots of peanuts to move without being remilled, helping to reduce handling costs.

Peanuts are also used for many different products, including outlets where cosmetic damage is not as important, such as peanut butter, where the manufacturers are willing to purchase lots with a higher percentage of damage. Most manufacturers are setting their own tolerance levels for damage based on the products they manufacture. By increasing the amount of allowable damage, more peanuts would be available to be manufactured for human consumption, helping to maximize shipments and improving returns. Therefore, this proposed rule would relax the allowance for damage and defects to 3.5 percent for all unshelled peanuts, kernels, and for cleaned-inshell peanuts.

This rule would also make changes to the PLI requirements and the recordkeeping and reporting requirements under the Standards. In the Standards, the PLI requirements are used to help maintain the identity of peanuts throughout the handling process, thus maintaining the integrity of lots being shipped to human consumption outlets, lots that are subject to the reconditioning process, and lots that are disposed of in non-human consumption outlets. PLI also helps ensure that peanuts certified for human consumption meet the outgoing requirements for grade and aflatoxin. In addition, the PLI requirements are a useful tool in product traceability and helping to ensure compliance with the Standards.

The reporting and recordkeeping requirements also play a role in ensuring compliance. Handlers and importers are required to maintain all relevant documentation on the disposition of inedible peanuts. The documentation maintained must be sufficient to document and substantiate the proper disposition of all peanut lots failing grade or aflatoxin quality standards. Reports and records are used to track and document the disposition of peanuts and to substantiate handler and importer compliance with the Standards.

In 2009, the peanut industry began the process of completely restructuring its tracking and reporting systems under an industry-wide food safety system, utilizing industry experts as well as guidance from the Food and Drug Administration, the Grocery Manufacturers Association, and finished product manufacturers. The industry also decided to work toward meeting the Global Food Safety Initiative (GFSI) standards that were being mandated by many major food manufacturers. GFSI certification requires, in part, that a company shall be able to trace all raw material product lots, including packaging, from its suppliers through all stages of processing and dispatch to its customers. The industry reports that in 2010, the industry had its first audits performed against the GFSI standards, and many in the industry are now certified under a GFSI scheme.

The purpose of this effort was to reduce the need for multiple audits while providing ongoing assurance of compliance within the industry with food safety initiatives. Under these new industry procedures, all raw peanuts are lot coded, and there is a traceability system in place to track them throughout the handling process. Handlers currently trace all peanuts from the warehouse to final disposition, including edible, blanched, and oil stock. Further, lots are segregated throughout the handling process in order to maintain identity should there be a recall notice issued.

In reviewing the Standards, the APSA thought it is important to maintain PLI on all lots meeting outgoing requirements. This preserves the integrity of these lots and provides assurance to buyers that the peanuts have met all requirements, have not been commingled with lower grade peanuts, and are ready to be utilized for human consumption. In addition, all peanut manufacturers require the official grade and aflatoxin certificate before taking possession of the peanuts to confirm that the analytical and physical tests required by law have been conducted.

However, given the industry's new requirements for tracking and traceability, the APSA found the remaining PLI requirements in the Standards to be redundant and no longer necessary. When the Standards were implemented in 2002, the current industry traceability systems had not yet been developed, and PLI was an important tool in maintaining compliance. The new traceability systems are used by the industry to help maintain the identity of peanuts throughout the handling process, the same way PLI is used. These systems are also used to track peanuts that are to be reconditioned or disposed of in non-human consumption outlets, such as for seed or animal feed. The industry reports that each peanut handler has designed a traceability system that is specifically integrated into their operations, and the industry believes that these systems largely perform all the same functions as PLI. Further, these systems were also designed to meet the new demands under food safety requirements, such as the Food Safety and Modernization Act, and the food safety and handling requirements set by the manufacturers. The industry believes having to utilize PLI in addition to its own tracking systems requires additional time and recordkeeping to follow peanuts that already have documented traceability.

The APSA proposal, as approved by the Board, recommends revision of the Standards to reflect current industry traceability programs. The industry believes that these changes would reduce handling and inspection costs and help improve the efficiency of handling operations. Consequently, this proposed rule would add language to § 996.73 of the Standards to define the necessary requirements for an industry-based traceability system and would provide allowances for systems meeting these requirements to be used in place of PLI prior to inspection and certification. The existing PLI system would also remain in place as a requirement for any handler who does not have a system in place that would meet the requirements for an industry-based traceability system and for any handler who would like to use PLI in conjunction with their own traceability system. However, PLI would still continue to be required for all peanuts meeting the outgoing standards.

This proposed rule would also revise the reporting and recordkeeping requirements under the Standards. All handlers and importers are currently required to submit to USDA a monthly report documenting their monthly farmers stock acquisitions. Under the proposed changes, the requirement to submit this monthly report would be eliminated. The industry stated that the information contained within the form was already being submitted to USDA on a daily basis as part of the farmers stock inspection process. Further, industry representatives stated that this data is maintained as part of the traceability systems now in place. Therefore, the industry supported the removal of this requirement.

Additional changes were recommended to recognize the reporting and recordkeeping done by the industry to meet the tracking and traceability requirements now required of the industry for food safety initiatives. In addition to records relating to peanuts meeting the outgoing standards, handlers and importers are required to maintain all relevant documentation on the disposition of inedible peanuts as part of their food safety traceability requirements. Given the traceability and recordkeeping requirements recommended to be added to the Standards and the recordkeeping requirements demanded under food safety requirements, the industry questioned the continued need for USDA to have access to all such records under the Standards. Industry representatives stated that they no longer saw a need for USDA to require regular access to records other than those pertaining to peanuts meeting the outgoing requirements. Consequently, pursuant to the Board-approved recommendation, this proposed rule would modify the reporting requirements to specify that USDA would be permitted to inspect any peanuts meeting outgoing requirements and any and all records pertaining to peanuts meeting outgoing quality regulations. However, pursuant to the Act, the Secretary shall work to provide adequate safeguards regarding all quality concerns related to peanuts. Therefore, this change would not preclude USDA from having access to all materials and records necessary should there be a situation necessitating an investigation or review to ensure compliance. The documentation maintained must still be sufficient to document and substantiate the proper disposition of all peanuts failing grade or aflatoxin quality standards.

The APSA proposal as approved by the Board also recommended revising the Standards to clarify that handlers and importers are not producing a finished product and that the peanuts would require further processing prior to human consumption. This would include amending the definition for peanuts in the Standards to indicate that the peanuts covered under the Standards are raw peanuts and intended for further processing by manufacturers prior to human consumption. The definitions for inshell and shelled peanuts would also be revised to reflect that the peanuts covered by the Standards are in their raw, natural state. The definition of peanuts would continue to provide that green peanuts, which are raw, for consumption as boiled peanuts are not subject to regulation under the Standards. However, these green peanuts are sold mostly by producers, not by handlers and importers, and make up a small share of the peanut market. The change to the definition for peanuts would also provide that peanuts intended for wildlife are also not subject to regulation under the Standards.

This change would also eliminate all references to roasting in the Standards to further clarify that handlers and importers are not producing a finished product. At one time, roasting was used to reduce levels of aflatoxin and was included in the Standards for that purpose. However, roasting is no longer used to treat aflatoxin. The Board supported these proposed changes to reduce any confusion that handlers and importers under the Standards are delivering a finished product ready for human consumption.

Finally, this proposed rule would also make numerous other changes throughout the Standards to update language and to reflect current industry practices and changes. Such changes include a change to the crop year, eliminating language relating to the old quota system, and updating outdated information, such as incorrect addresses, titles, and other contact information. It would also remove the requirement that peanuts testing at or above 301 ppb of aflatoxin can only be disposed of through crushing or export, as cleaning technology has improved to the point that peanuts testing at or above this level may possibly be cleaned to meet the outgoing standards.

The proposed changes approved by the Board also included a recommendation to remove the lot size limit of 200,000 pounds on peanuts presented for outgoing inspection. However, the 200,000 pound limit is required by USDA and the inspection service to ensure an accurate sampling protocol. Therefore, the 200,000 pound lot limit would be maintained.

USDA is also adding an additional change under this proposed rule that would revise the requirements for imported peanuts under § 996.60(a). This change would modify how importers submit their entry information to USDA. This section currently references the “stamp and fax” entry process, which is being replaced by the International Trade Data System, a system that will automate the filing of import and export information. This proposed change would revise this section to reflect the new electronic entry process.

The Board believes these changes would bring the Standards closer in line with current industry practices, make additional peanuts available for sale, help reduce costs, and make operations more efficient. These proposed changes are consistent with the Standards and the Act.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened.

Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms, including handlers and importers, are defined as those having annual receipts of less than $7,000,000 (13 CFR 121.201).

There are approximately 7,500 peanut producers; 65 peanut handlers, operating approximately 70 shelling plants; and 25 importers subject to regulation under this peanut program.

An approximation of the number of peanut farms that could be considered small agricultural businesses under the SBA definition can be obtained from the 2012 Agricultural Census, which is the most recent information on the number of farms categorized by size. There were 3,066 peanut farms with annual agricultural sales valued at less than $500,000 in 2012, representing 47 percent of the total number of peanut farms in the U.S. (6,561). According to the National Agricultural Statistics Service (NASS), peanut production for the 2014 and 2015 crop years averaged 5.756 billion pounds. The average value of production for the two-year period was $1.088 billion. The average grower price over the two-year period was $0.25 per pound. Dividing the two-year average production value of $1.088 billion by the approximate number of peanut producers (7,500) results in an average revenue per producer of approximately $145,000, which is well below the SBA threshold for small producers. Based on information and reports received by USDA, more than 50 percent of handlers may be considered small entities. Further, the estimated value of peanuts imported into the United States in 2014 was approximately $64 million. Based on that number, the majority of importers would meet the SBA definition for small agricultural service firms. Consequently, a majority of handlers, importers and producers may be classified as small entities.

The current 10 custom blanchers, 4 custom remillers, 3 oil mill operators, and 1 USDA and 17 USDA-approved private chemical (aflatoxin) laboratories are subject to this rule to the extent that they must comply with reconditioning provisions under § 996.50 and reporting and recordkeeping requirements under § 996.71. These requirements are applied uniformly to these entities, whether large or small.

This proposed rule would revise the minimum quality, positive lot identification, and reporting and recordkeeping requirements under the Standards. This proposal would also make numerous other changes to the Standards to better reflect current industry practices and to revise outdated language. The Board believes these changes would make additional peanuts available for sale, help increase efficiencies, and reduce costs to the industry.

This proposed rule is issued under the Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States, as amended (7 CFR part 996), as established pursuant to Public Law 107-171, the Farm Security and Rural Investment Act of 2002.

It is not anticipated that this action would impose additional costs on handlers, producers, or importers, regardless of size. Rather, these changes should help the industry reduce costs by helping to increase efficiencies. The industry believes the requirement that they continue to use PLI in addition to its own internal traceability systems creates redundancy and additional costs. By recognizing its internal traceability programs as an alternative to PLI, this should improve efficiencies and reduce costs. In addition, this proposal should also make additional peanuts available for sale, helping to maximize shipments and improving industry returns.

This proposed rule is expected to benefit the industry. The effects of this rule are not expected to be disproportionately greater or less for small handlers, producers or importers than for larger entities.

USDA has considered alternatives to these changes. The Act requires USDA to consult with the Board on changes to the Standards. An alternative would be to continue the Standards in their current form. However, the industry believes the proposed changes would increase efficiencies, make additional peanuts available for sale, and help update the Standards. Therefore, because of the anticipated benefits of the recommended changes, this alternative was rejected. USDA has met with the Board, which is representative of the industry, and has included nearly all of its recommendations in this proposed rule.

The Act specifies in § 1601(c)(2)(A) that the Standards established pursuant to it may be implemented without regard to the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). However, USDA has considered the reporting and recordkeeping burden on handlers and importers under this program. Handlers and importers are only required currently to complete one form, the monthly acquisition of farmers stock peanuts. Under this proposed rule, this requirement would be removed, reducing the reporting burden. Recordkeeping requirements would remain the same. Accordingly, this rule will not impose any additional reporting or recordkeeping requirements on either small or large handlers or importers.

Section 1601 of the Act also provides that amendments to the Standards may be implemented without extending interested parties an opportunity to comment. However, due to the nature of the proposed changes, interested parties are provided with a 60-day comment period.

AMS is committed to complying with the E-Government Act to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

The Board's meetings were widely publicized throughout the peanut industry, and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 26, 2015, and the November 18, 2015, meetings were public meetings, and all entities, both large and small, were able to express views on these issues. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and informational impacts of this action on small businesses.

A 60-day comment period is provided to allow interested persons an opportunity to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.

For the reasons set forth in the preamble, 7 CFR part 996 is proposed to be amended as follows:

The revisions read as follows:

The revisions read as follows:

The revisions read as follows:

The revisions read as follows:

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-2015-8465; Directorate Identifier 2014-NM-239-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 11, 2001, we issued AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001). AD 2001-12-18 requires actions intended to address an unsafe condition on certain CASA Model CN-235 series airplanes.

Since we issued AD 2001-12-18, Amendment 39-12274 (66 FR 33014, June 20, 2001), we have received reports of new occurrences of cable disruption on part number (P/N) 72830-20; the disruption is caused by microcracks along the cable surface.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2014-0262, dated December 5, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Defense and Space S.A. Model CN-235-100 and -200 airplanes. The MCAI states:

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-2015-8464; Directorate Identifier 2015-NM-050-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.

Transport Canada Civil Aviation (TCCA), which is the aviation authority for Canada, has issued Canadian Airworthiness Directive CF-2014-43, dated December 18, 2014 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for all Bombardier, Inc. Model DHC-8-400 series airplanes. The MCAI states:

You may examine the MCAI in the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2015-8464.

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.

This AD requires revisions to certain operator maintenance documents to include new actions (e.g., inspections). Compliance with these actions is required by 14 CFR 91.403(c). For airplanes that have been previously modified, altered, or repaired in the areas addressed by this AD, the operator may not be able to accomplish the actions described in the revisions. In this situation, to comply with 14 CFR 91.403(c), the operator must request approval for an alternative method of compliance according to paragraph (h)(1) of this AD. The request should include a description of changes to the required inspections that will ensure the continued operational safety of the airplane.

We estimate that this proposed AD affects 82 airplanes of U.S. registry.

We also estimate that it would take about 1 work-hour per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $6,970, or $85 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);

3. Will not affect intrastate aviation in Alaska; and

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

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

In response to requests from members of the public, the Department has decided to extend the public comment period for the notice of proposed rulemaking it published on November 18, 2015 (80 FR 72296). The 60-day comment period that was originally scheduled to close on January 19, 2016 is being extended for another 30 days through February 18, 2016.

The notice of proposed rulemaking contains changes to the regulations governing the administration of the Energy Employees Occupational Illness Compensation Program Act of 2000, as amended (EEOICPA or Act), 42 U.S.C. 7384 et seq., which was originally enacted on October 30, 2000. The initial version of EEOICPA established a compensation program (known as Part B of the Act) to provide a uniform lump-sum payment of $150,000 and medical benefits as compensation to covered employees who had sustained designated illnesses due to their exposure to radiation, beryllium or silica while in the performance of duty for DOE and certain of its vendors, contractors and subcontractors. Part B of the Act also provides for payment of compensation to certain survivors of these covered employees, and for payment of a smaller uniform lump-sum ($50,000) to individuals (who would also receive medical benefits), or their survivors, who were determined to be eligible for compensation under section 5 of the Radiation Exposure Compensation Act (RECA), 42 U.S.C. 2210 note, by DOJ. Primary responsibility for the administration of Part B of the Act was assigned to DOL by Executive Order 13179 (“Providing Compensation to America's Nuclear Weapons Workers”) of December 7, 2000 (65 FR 77487).

The initial version of EEOICPA also created a second program (known as Part D of the Act) that required DOE to establish a system by which DOE contractor employees (and their eligible survivors) could seek assistance from DOE in obtaining state workers' compensation benefits if a Physicians Panel determined that the employee in question had sustained a covered illness as a result of work-related exposure to a toxic substance at a DOE facility. A positive panel finding that was accepted by DOE required DOE, to the extent permitted by law, to order its contractor not to contest the claim for state workers' compensation benefits. However, Congress amended EEOICPA in Subtitle E of Title XXXI of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005, Public Law 108-375, 118 Stat. 1811, 2178 (October 28, 2004), by abolishing Part D of the Act and creating a new Part E (codified at 42 U.S.C. 7385s through 7385s-15) that it assigned to DOL for administration. Part E established a new system of variable federal payments for DOE contractor employees, uranium workers covered by section 5 of RECA, and eligible survivors of such employees.

In 1974, Congress designated the 57-mile Chattooga River (and its 15,432-acre corridor) as a component of the National Wild and Scenic River System. The uppermost portion of the Chattooga Wild and Scenic River is located in the Nantahala National Forest (NF) in North Carolina. The river then flows in a southerly, south-westerly direction to form the boundary between Georgia and South Carolina, and also the boundary between the Chattahoochee NF (in Georgia) and the Sumter NF (in South Carolina).

In the initial 1976 river management plan for the Chattooga River, the U.S. Forest Service used zoning to manage the upper and lower segments of the river for different recreational opportunities. As part of the initial zoning effort, management direction prohibited floating on the upper segment above GA/SC Highway 28 (which includes a section of the river in the Sumter NF in South Carolina, a section of the river in the Chattahoochee NF in Georgia, and all of the sections of the river in the Nantahala NF in North Carolina).

Under the authority of 36 CFR 261.70(a)(7), these prohibitions were codified at 36 CFR 261.77 (Federal Register, 43 FR 3706, January 27, 1978). In general terms, 36 CFR 261.77 prohibits floating activities on the Chattooga Wild and Scenic River unless authorized by a permit. Consistent with the river management plan that is incorporated into the forest plans, the original terms and conditions of the permits issued pursuant to 36 CFR 261.77 allowed floating on the Chattooga Wild and Scenic River but only on that portion of the river located downstream of GA/SC Highway 28. Therefore, due to the combination of 36 CFR 261.77 and the terms of the self-registration permit issued pursuant to that regulation, floating was allowed on that section of the river downstream of GA/SC Highway 28 and prohibited upstream from that location. However, that management direction has changed, allowing for an increase in boating opportunities upstream of GA/SC Highway 28. To be consistent with this new management direction, the agency proposes to amend 36 CFR 261.77.

On January 31, 2012, the Chattahoochee, Nantahala and Sumter National Forests issued Decision Notices that amended their Forest Plans to incorporate new management direction for the Chattooga Wild and Scenic River. These changes are based upon an Environmental Assessment titled “Managing Recreation Uses in the Upper Segment of the Chattooga Wild and Scenic River Corridor”. Generally, these new decisions allow floating above GA/SC Highway 28 with certain restrictions.

In the existing regulations at 36 CFR 261.77, the sections of the river that lie within the Nantahala NF in North Carolina are not addressed. This area is instead regulated by Forest Supervisor's closure order pursuant to subpart B of 36 CFR part 261. In the interest of efficiency and clarity, and to be consistent with the new management direction, the Forest Service proposes to amend 36 CFR 261.77 to include sections of the river that lie within the Nantahala NF. Consistent with the new management direction, the Forest Service also proposes to amend 36 CFR 261.77 to include the Sumter and Nantahala NFs in certain provisions that currently only include the Chattahoochee NF. In the interest of further consistency and clarity, and to better serve the public, the Forest Service also proposes to amend 36 CFR 261.77 by eliminating reference to specific locations where self-registration permits are made available to the public. Instead, the Agency will use other means to inform the public of the variety of places where it can go to obtain permits to float the Chattooga Wild and Scenic River. Lastly, in an effort to use more accurate and consistent terminology, the Forest Service proposes to replace the term “special use permit” with the term “special use authorization.”

Currently, § 261.77(a) applies to the Sumter National Forest and the Chattahoochee National Forest abutting the Chattooga River. However, this regulation is silent about that section of the Chattooga Wild and Scenic River Corridor that is located upstream of the Sumter and Chattahoochee NFs which lies within the Nantahala NF in North Carolina. The January 31, 2012, decision by the Forest Service allows for additional boating to occur under permit in the upper section of the Chattooga River which in-part is located in North Carolina on the Nantahala NF. Therefore, the regulation needs to be revised to include the Nantahala NF. The Agency proposes that § 261.77(a) now be applicable to “any area of National Forest land abutting the Chattooga River.” A parenthetical sentence will then be added to clarify that “(The Chattooga River is located in the Nantahala National Forest in North Carolina, the Sumter National Forest in South Carolina and the Chattahoochee National Forest in Georgia.)”

Due to the allowance of additional floating on the Chattooga River, the Agency must be able to issue permits in a flexible and efficient manner that is consistent with the new management direction and in a manner that best serves the public. Rather than codifying the specific locations of self-registration permit stations in the regulations, these locations will be identified by the local Forest Service officials administering the different sections of the Chattooga River. Locations of the registration stations may need to be changed from time to time to better serve the public. In addition, the Forest Service may, in the future, develop an option where permits could be obtained online or through other more efficient and effective means. To achieve this need, the specific locations of the “Forest Service Registration Stations” are being removed and the regulation will simply state that the use will need to be “authorized by permit or through a special use authorization”.

Similar to § 261.77(a), § 261.77(b) currently applies to “. . . the Sumter National Forest and the Chattahoochee National Forest abutting the Chattooga River.” However, this regulation is also silent about that section of the Chattooga Wild and Scenic River Corridor that lies within the Nantahala NF in North Carolina. Again, since the January 31, 2012, decision by the US Forest Service allows for additional boating to occur under permit in the upper section of the Chattooga River, the regulation needs to be revised to include the Nantahala NF. The agency proposes that § 261.77(b) now is applicable to “any area of National Forest System land abutting the Chattooga River.” As noted above, a parenthetical sentence will then be added to clarify that “(The Chattooga River is located in the Nantahala National Forest in North Carolina, the Sumter National Forest in South Carolina and the Chattahoochee National Forest in Georgia.)” Finally, the term “unless authorized by special use permit” is also being replaced with the term “unless permitted under a special use authorization”.

Section 261.77(c) currently only applies to “. . . the terms or conditions of any permit authorizing the occupancy and use . . .” However, in § 261.77(a) and (b), a distinction is now being made between a “permit” and a “special use authorization”. So proposed § 261.77(c) is revised to apply to “. . .the terms or conditions of any special use authorization or permit authorizing the occupancy and use . . .”

Section 261.77(d) applies to “. . . any portion or segment of the Chattooga River within the boundaries of the Chattahoochee National Forest . . .” However, as stated above, the Chattooga Wild and Scenic River flows through all three forests; the Chattahoochee NF, the Sumter NF and the Nantahala NF. In addition, the new management direction applies to all three forests. Therefore, this provision needs to be revised to include all three forests. So, proposed § 261.77(d) is revised to apply to “. . . any portion or segment of the Chattooga River within National Forest System land . . .”

In addition, as discussed above, in the interest of consistency, efficiency and clarity, to best serve the public, specific locations to obtain self-registration permits will no longer be codified. Rather, these locations will be identified by the local Forest Service officials administering the different sections of the Chattooga River. The locations of the registration stations may need to be changed from time to time to better serve the public. It should also be recognized that the Forest Service may, in the future, develop an option where permits could be obtained online or in some other efficient manner that better serves the public. In order to address this, the specific locations of the “Forest Service Registration Stations” are being removed and the proposed regulation will simply state that the use will need to be “authorized by permit or through a special use authorization.”

Similar to § 261.77(d), the scope of the commercial or business operation prohibitions currently in § 261.77(e) only applies to “. . . any portion or segment of the Chattooga River within the boundaries of the Chattahoochee National Forest . . .” As described above, the regulation needs to be revised to also include all three national forests. Therefore, § 261.77(e) is revised to read, “Entering, going, riding, or floating . . . upon any portion or segment of the Chattooga River within National Forest System land . . .” Finally, the term “unless authorized by special use permit” is also being replaced with the term “unless permitted under a special use authorization.”

Section 261.77(f) currently only applies to “. . . the terms or conditions of any permit authorizing the occupancy and use . . .” However, in § 261.77(d) and (e), a distinction is now being made between a “permit” and a “special use authorization”. So proposed § 261.77(f) is revised to apply to “. . .the terms or conditions of any special use authorization or permit authorizing the occupancy and use . . .”

This proposed rule is to amend an existing regulation to make it consistent with a USDA, Forest Service decision on the management of the Chattooga Wild and Scenic River, which lies within the Chattahoochee, Nantahala and Sumter National Forests. The Decision Notices (one for each National Forest) were signed on January 31, 2012, which were based upon an Environmental Assessment (EA) titled “Managing Recreation Uses in the Upper Segment of the Chattooga Wild and Scenic River Corridor.” The social and environmental effects of this decision are documented in this EA. This proposed rule amendment is to update the Forest Service regulations to now be consistent with this new management decision.

This proposed rule has been reviewed under USDA procedures and Executive Order 12866 on regulatory planning and review. It has been determined that this is not a significant proposed rule. This rulemaking will not have an annual effect of $100 million or more on the economy, nor will it adversely affect productivity, competition, jobs, the environment, public health and safety, or State or local governments. This rulemaking will not interfere with an action taken or planned by another agency, nor will it raise new legal or policy issues. Finally, this proposed rule will not alter the budgetary impact of entitlement, grant, user fee, or loan programs or the rights and obligations of beneficiaries of such programs. Accordingly, this rulemaking is not subject to Office of Management and Budget (OMB) review under Executive Order 12866.

This proposed rule has been considered in light of the Regulatory Flexibility Act (5 U.S.C. 602 et seq.). The proposed rule makes minor, technical changes to the Forest Service's regulations. This rulemaking will not have a significant economic impact on a substantial number of small entities as defined by the act because the rulemaking will not impose recordkeeping requirements on them; it will not affect their competitive position in relation to large entities; and it will not affect their cash flow, liquidity, or ability to remain in the market.

This proposed rule has been analyzed in accordance with the principles and criteria contained in Executive Order 12630. It has been determined that the rulemaking will not pose the risk of a taking of private property.

This proposed rule has been reviewed under Executive Order 12988 on civil justice reform. After adoption of this proposed rule, (1) all State and local laws and regulations that conflict with this rulemaking or that impede its full implementation will be preempted; (2) no retroactive effect will be given to this rule; and (3) it will not require administrative proceedings before parties may file suit in court challenging its provisions.

The Department has considered this proposed rule under the requirements of Executive Order 13132 on federalism, and has determined that the rulemaking conforms with the federalism principles set out in this Executive Order; will not impose any compliance costs on the States; and will not have substantial direct effects on the States, the relationship between the Federal government and the States, or the distribution of power and responsibilities among the various levels of government. Therefore, the Department has determined that no further assessment of federalism implications is necessary.

Moreover, this proposed rule is not expected to have Tribal implications as defined by Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The Department does recognize that one or more Indian Tribes may have direct interest in the management of Chattooga Wild & Scenic River. Therefore, the Department will request consultation with all potentially affected Indian Tribes on this proposed rule. The tribal consultation will be held concurrently with the public comment period.

This proposed rule has been reviewed under Executive Order 13211 of May 18, 2001, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. It has been determined that this proposed rule does not constitute a significant energy action as defined in the Executive Order.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), which the President signed into law on March 22, 1995, the Department has assessed the effects of this proposed rule on State, local, and Tribal governments and the private sector. This rulemaking will not compel the expenditure of $100 million or more by any State, local, or Tribal government or anyone in the private sector. Therefore, a statement under section 202 of the act is not required.

This proposed rule does not contain any recordkeeping or reporting requirements or other information collection requirements as defined in 5 CFR part 1320 that are not already required by law or not already approved for use. Accordingly, the review provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and its implementing regulations at 5 CFR part 1320 do not apply.

Therefore, for the reasons set out in the preamble, we propose to amend part 261 of title 36 of the Code of Federal Regulations as follows:

This supplementary information is organized as follows:

This proposed rule applies to federally recognized tribal governments with reservations interested in seeking TAS eligibility to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program. Although this proposed rule would not apply directly to any other entity, state and local governments or other Indian tribes, as well as other entities, may be interested to the extent they are adjacent to the Indian reservation1 lands of TAS applicant tribes, share water bodies with such tribes, and/or discharge pollutants to waters of the United States located within or adjacent to such reservations. The table below provides examples of entities that could be affected by this action or have an interest in it.

If you have questions regarding the effect of this proposed rule on a particular entity, please consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.

Under section 518(e) of the CWA, 33 U.S.C. 1377(e), Indian tribes may seek TAS authorization to administer certain CWA programs pertaining to water resources of their reservations. Tribes are not eligible to administer CWA programs pertaining to any non-reservation Indian country 2 or any other type of non-reservation land. The term “federal Indian reservation” is defined at CWA section 518(h)(1) to include all land within the limits of any Indian reservation under the jurisdiction of the United States Government notwithstanding the issuance of any patent, and including rights-of-way running through the reservation. See CWA sections 518(e)(2), (h)(1); see also 40 CFR 131.3(k). EPA's longstanding position is that reservations include both formal reservations (e.g., named reservations established through federal treaties with tribes, federal statutes, or Executive Orders of the President) as well as tribal trust lands that may not be formally designated as reservations, but that qualify as informal reservations. See, e.g., 56 FR 64876, 64881 (December 12, 1991); Arizona Public Service Co. v. EPA, 211 F.3d 1280, 1292-1294 (D.C. Cir. 2000), cert. denied sub nom., Michigan v. EPA, 532 U.S. 970 (2001). Tribes may seek TAS authorization for both formal and informal reservations, and both types of lands are referred to herein as “reservations.”

Although this proposal would facilitate eligible tribes' administration of an additional regulatory program, nothing in this proposed rule changes, expands, or contracts the geographic scope of potential tribal TAS eligibility under the CWA.

1. Resubmitting Relevant Comments from Consultations and Listening Sessions. EPA held multiple consultations and listening sessions with tribes and states concerning TAS for CWA section 303(d) lists and TMDLs, and considered views and comments received from these sessions in developing this proposal. This proposed rule has evolved from the materials EPA shared at the time. Therefore, if you submitted comments based on these sessions and want EPA to consider them as part of the public comment opportunity for this proposed action, you must resubmit your comments to EPA in accordance with the instructions outlined in this document.

2. Submitting CBI. Do not submit CBI to EPA through http://www.regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disc that you mail to EPA, mark the outside of the disc as CBI and then identify electronically within the disc the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. EPA will not disclose information so marked except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

3. Tips for Preparing Your Comments. When submitting comments, remember to:

• Identify the proposed action by docket number and other identifying information (subject heading, Federal Register date and page number).

• Explain why you agree or disagree, suggest alternatives, substitute language for your requested changes.

• Describe any assumptions and provide any technical information and/or data that you used.

• If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

• Provide specific examples that help to illustrate your concerns.

• Explain your views as clearly as possible.

• Submit your comments consistent with the DATES section of this document.

Congress added section 518 to the CWA as part of amendments made in 1987. Section 518(e) authorizes EPA to treat eligible Indian tribes in the same manner as it treats states for a variety of purposes, including administering each of the principal CWA regulatory programs and receiving grants under several CWA funding authorities. Section 518(e) is commonly known as the “TAS” provision. Section 303 is expressly identified in section 518(e) as one of the provisions available for TAS.

Section 518(e) also requires EPA to promulgate regulations specifying the TAS process for applicant tribes. Section 518(h) defines “Indian tribe” to mean any Indian tribe, band, group, or community recognized by the Secretary of the Interior and exercising governmental authority over a federal Indian reservation.

Pursuant to section 518(e), EPA promulgated several final regulations establishing TAS criteria and procedures for Indian tribes interested in administering programs under the Act. The relevant regulations addressing TAS requirements for the principal CWA regulatory programs are:

• 40 CFR 131.8 for section 303(c) water quality standards, published at 56 FR 64876 (December 12, 1991) (final rule);

• 40 CFR 131.4(c) for CWA section 401 water quality certification, published at 56 FR 64876 (December 12, 1991);

• 40 CFR 123.31-34 for CWA section 402 National Pollutant Discharge Elimination System (NPDES) permits and other provisions, and 40 CFR 501.22-25 for the sewage sludge management program. Final rule published December 22, 1993 (58 FR 67966); and

• 40 CFR 233.60-62 for CWA section 404 dredge or fill permits. Final rule published February 11, 1993 (58 FR 8172).

In 1994, EPA amended the above regulations to simplify the TAS process and eliminate unnecessary and duplicative procedural requirements. See 59 FR 64339 (December 14, 1994) (the “Simplification Rule”). For example, the Simplification Rule eliminated the need for a tribe to prequalify for TAS before applying to administer the section 402 and section 404 permit programs. Instead, the rule provided that a tribe would seek to establish its TAS eligibility at the program approval stage (subject to notice and comment procedures in the Federal Register). However, the rule retained the separate TAS prequalification requirement (including local notice and comment procedures) for section 303(c) water quality standards and section 401 water quality certifications. Id.; see also, 40 CFR 131.8(c)(2), (3).3 The TAS regulations for CWA regulatory programs have remained intact since promulgation of the Simplification Rule. EPA is now proposing to address a gap in its current TAS regulations, by proposing regulations that would specify how tribes may seek TAS for the Section 303(d) Impaired Water Listing and TMDL Program.

TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program would provide a tribe with the opportunity to participate directly in restoring and protecting its reservation waters through implementing the Program, as Congress authorized under CWA section 518(e). In the rest of this document, EPA refers to the functions identified in CWA section 303(d) regarding listing of impaired waters and establishment of TMDLs as the “Section 303(d) Impaired Water Listing and TMDL Program” or “303(d) Program.” Section 303(d) provides for states and authorized tribes to: (1) Develop lists of impaired waters (and establish priority rankings for waters on the lists) and (2) establish TMDLs for these waters. By listing impaired waters, a state or authorized tribe identifies those waters in its territory that are not currently meeting EPA-approved or EPA-promulgated WQS (collectively referred to as “applicable WQS”). A TMDL is a planning document intended to address impairment of waters, including the calculation and allocation to point and nonpoint sources of the maximum amount of a pollutant that a water body can receive and still meet applicable WQS, with a margin of safety.

By obtaining TAS for section 303(d), tribes can take the lead role in identifying and establishing a priority ranking for impaired water bodies on their reservations and in establishing TMDLs and submitting them to EPA for approval. These are important informational and planning steps that tribes can take to restore and maintain the quality of reservation waters.

TMDLs must allocate the total pollutant load among contributing point sources (“waste load allocations” or “WLAs”) and nonpoint sources (“load allocations” or “LAs”) (40 CFR 130.2). Point source WLAs are addressed through the inclusion of water quality-based effluent limits in national pollutant discharge elimination system (NPDES) permits issued to such sources. Under EPA's regulations, NPDES permitting authorities shall ensure that “[e]ffluent limits developed to protect a narrative water quality criterion, a numeric water quality criterion, or both, are consistent with the assumptions and requirements of any available wasteload allocation for the discharge prepared by the State and approved by EPA pursuant to 40 CFR 130.7.” 40 CFR 122.44(d)(1)(vii)(B). WLAs under 40 CFR 122.44(d)(1)(vii)(B) would include WLAs developed by a tribe with TAS authorization and approved by EPA pursuant to 40 CFR 130.7. For water bodies impaired by pollutants from nonpoint sources, authorized tribes would not acquire new or additional implementation authorities when listing such impaired water bodies and establishing TMDLs. Instead, the mechanisms for implementing the nonpoint source pollutant reductions (LAs) identified in any tribal TMDLs would include existing tribal authorities, other federal agencies' policies and procedures, as well as voluntary and incentive-based programs.

This proposed rule would not require anything of tribes that are not interested in TAS for the 303(d) Program. Based on pre-proposal input, not all tribes will be interested in obtaining TAS for 303(d), and some may consider other approaches that might benefit their reservation waters. Clean Water Act section 319 watershed-based plans, for example, may help tribes protect and restore water resources threatened or impaired by nonpoint source pollution.4

The goal of the CWA is “to restore and maintain the chemical, physical, and biological integrity of the Nation's waters.” CWA section 101(a). Identification of impaired waters and TMDLs are important tools for achieving that goal. After a tribe receives EPA approval of its eligibility to implement a CWA Section 303(d) Impaired Water Listing and TMDL Program, it is treated in a manner similar to a state and, for purposes of list and TMDL development, it would become an “authorized tribe.” Generally, the federal statutory and regulatory requirements for state 303(d) programs would be applicable to authorized tribes (see proposed § 130.16(c)(5)). The following paragraphs identify important 303(d) Program responsibilities that tribes with TAS would assume and implement.

Under section 303(d) of the CWA, every two years authorized tribes would be required to develop lists of waters not meeting, or not expected to meet, applicable water quality standards. 40 CFR 130.7(d). These lists are commonly called “impaired waters lists” or “303(d) lists.” Impaired waters are waters for which technology-based limitations and other required controls are not stringent enough to meet applicable CWA water quality standards. Threatened waters are waters that currently attain applicable WQS, but for which existing and readily available data and information indicate that applicable WQS will likely not be met by the time the next list of impaired or threatened waters is due to EPA.5 The authorized tribe's section 303(d) list would include all impaired and threatened waters. In this document, EPA uses the term “impaired waters” to refer to both impaired and threatened waters.6 The authorized tribe would be required to “assemble and evaluate all existing and readily available information” in developing its section 303(d) list. 40 CFR 130.7(b)(5). EPA's regulations include a non-exhaustive list of water quality-related data and information to be considered. Id. The tribe would establish priorities for development of TMDLs for waters on its section 303(d) list based on the severity of the pollution and the uses to be made of the waters. 40 CFR 130.7(b)(4). The tribe would then submit its list of impaired waters to EPA for review and approval.

Like states, authorized tribes would be required to submit their “303(d) lists” to EPA for approval every two years on April 1 (lists are due April 1 of even-numbered years). As indicated in § 130.16(c)(5) of the proposed rule, a tribe gaining TAS status would be provided at least 24 months to submit its first impaired waters list to EPA. The tribe's first impaired waters list would be due to EPA the next listing cycle due date that is at least 24-months from the later of (1) the date the tribe's TAS application for 303(d) is approved, or (2) the date EPA-approved/promulgated WQS for the tribe's waters are effective. (See section VII for the procedure EPA would follow in reviewing a tribe's TAS application.). Thus, for example, if EPA approves a tribe's TAS application on March 15, 2016, and the tribe's WQS on June 30, 2016, the tribe's first list would be due on April 1, 2020. The tribe could submit its list to EPA prior to that date, if it chooses.

Most tribes that would be eligible for TAS authorization under today's proposed rule are likely to be recipients of CWA section 106 grants and would thus be required to submit section 106 grant work plans annually. If a tribe's CWA section 106 grant work plan includes ambient water quality monitoring activities, the tribe is also required to develop an assessment report pursuant to the CWA section 106 grant reporting requirements.7 EPA encourages tribes that obtain TAS for the CWA Section 303(d) Program and also develop CWA section 106 assessment reports to combine their CWA section 303(d) impaired waters list with their CWA section 106 assessment report, and submit the combined report electronically through the Assessment TMDL Tracking and Implementation System (ATTAINS).8 In this way such tribes could create a combined CWA 303(d)/106 report that is similar to a state's CWA 303(d)/305(b) 9 “Integrated Report.” 10

Under the CWA, each state and authorized tribe must, “from time to time,” establish and submit TMDLs for pollutants causing impairments in all the waters on its 303(d) list. CWA sections 303(d)(1)(C) and 303(d)(2). States and authorized tribes set priorities for developing TMDLs for their impaired and listed waters.

TMDLs must be established “at a level necessary to implement the applicable water quality standards with seasonal variations and a margin of safety which takes into account any lack of knowledge concerning the relationship between effluent limitations and water quality.” CWA section 303(d)(1)(C). Where a TMDL makes allocation tradeoffs between point and nonpoint sources, the TMDL record must also demonstrate “reasonable assurance” that the nonpoint source allocations will be achieved. 40 CFR 130.2(i). Calculations to establish TMDLs must be subject to public review. 40 CFR 130.7(c)(1)(ii). Once established, the state or authorized tribe submits the TMDL to EPA for review.

Once EPA receives a list or TMDL, it must either approve or disapprove that list or TMDL within 30 days. CWA section 303(d)(2). If EPA disapproves the list or TMDL, EPA must establish a replacement list or TMDL within 30 days of disapproval. 40 CFR 130.7(d)(2).

Consistent with the statutory requirement in section 518 of the CWA, the proposed rule would establish the procedures by which an Indian tribe may apply and qualify for TAS for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program. Such procedures would be codified in a new section 130.16 of the water quality planning and management regulation. Section 130.16 would identify (1) the criteria an applicant tribe would be required to meet to be treated in a similar manner as states, (2) the information the tribe would be required to provide in its application to EPA, and (3) the procedure EPA would use to review the tribal application. Proposed section 130.16 is intended to ensure that tribes treated in a similar manner as states for the purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program are qualified, consistent with CWA requirements, to conduct a Listing and TMDL Program. The procedures are meant to provide more opportunities for tribes to engage fully in the Program and are not intended to act as a barrier to tribal assumption of the 303(d) Program.

The TAS procedures in this proposed rule are closely based on the existing TAS regulation at 40 CFR 131.8, which establishes the TAS process for the CWA Section 303(c) WQS Program. EPA established the TAS process for WQS in 1991, and that program has been the focus of the great majority of TAS activity for regulatory programs under the CWA as well as all of the other environmental statutes administered by the Agency. The WQS TAS rule has proven very effective in ensuring that applicant tribes satisfy statutory TAS criteria and are prepared to administer WQS programs under the Act. It thus served as a useful model for this proposed TAS rule.

The TAS criteria tribes would be required to meet for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program originate in CWA section 518. As reflected in the proposed regulatory language, the tribe must: (1) Be federally recognized and meet the definitions in § 131.3(k) and (l); (2) carry out substantial governmental duties and powers; (3) have appropriate authority to regulate the quality of reservation waters; and (4) be reasonably expected to be capable of administering the Impaired Water Listing and TMDL Program. These criteria are discussed below.

The first criterion for TAS would require the tribe to be federally recognized by the U.S. Department of the Interior (DOI) and meet the definitions in § 131.3(k) and (l). The tribe may address the recognition requirement either by stating that it is included on the list of federally recognized tribes published periodically by DOI, or by submitting other appropriate documentation (e.g., if the tribe is federally recognized but is not yet included on the DOI list). The definition of “tribe” in § 131.3(l), along with requiring federal recognition, additionally requires that the tribe is exercising governmental authority over a Federal Indian reservation. “Federal Indian reservation” is defined in § 131.3(k) as “all land within the limits of any Indian reservation under the jurisdiction of the United States Government, notwithstanding the issuance of any patent, and including rights-of-way running through the reservation.” (See further discussion of the term “reservation” in section I B. of this preamble.). The governmental authority and reservation aspects of these definitions would be addressed in the tribe's application, including as part of its descriptive statements that it currently carries out substantial governmental duties and powers over a defined area, and that it has authority to regulate water quality over a reservation.

The second criterion would require the tribe to have a governing body “carrying out substantial governmental duties and powers.” The Agency considers “substantial governmental duties and powers” to mean that the tribe is currently performing governmental functions to promote the health, safety, and welfare of the affected population within a defined geographical area. See 54 FR at 39101. Examples of such functions may include, but are not limited to, the power to tax, the power of eminent domain, and police power. Federal recognition by DOI would not, in and of itself, satisfy this criterion. EPA expects that most tribes should be able to meet this criterion without much difficulty. Id.

To address the second criterion, the tribe would be required to submit a descriptive statement demonstrating that the tribal governing body is currently carrying out substantial governmental duties and powers over a defined area. The descriptive statement should: (1) Describe the form of tribal government; (2) describe the types of essential governmental functions currently performed, such as those listed above; and (3) identify the sources of authorities to perform these functions (e.g., tribal constitutions and codes).

The third criterion, concerning tribal authority, means that a tribe seeking TAS for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program must adequately demonstrate authority to manage and protect water resources within the borders of the tribe's reservation. To verify authority and satisfy the third criterion of the proposed rule, a tribe would be required to include a statement signed by the tribal legal counsel, or an equivalent official, explaining the legal basis for the tribe's regulatory authority, and appropriate additional documentation (e.g., maps, tribal codes and ordinances).

In promulgating prior CWA TAS regulations, EPA took an initial cautious approach that required tribes applying for eligibility to administer regulatory programs under the statute to demonstrate their inherent tribal authority over the relevant regulated activities on their reservations. See, e.g., 56 FR at 64877-81. This included a demonstration of inherent regulatory authority over the activities of non-tribal members on lands they own in fee within a reservation under the principles of Montana v. United States, 450 U.S. 544 (1981), and its progeny. Montana held that, absent a federal grant of authority, tribes generally lack inherent jurisdiction over nonmember activities on nonmember fee land, but retain inherent civil jurisdiction over nonmember activities within the reservation where (i) nonmembers enter into “consensual relationships with the tribe or its members, through commercial dealing, contracts, leases, or other arrangements” or (ii) “. . . [nonmember] conduct threatens or has some direct effect on the political integrity, the economic security, or the health or welfare of the tribe.” Montana, 450 U.S. at 565-66.

In addressing the second exception of Montana regarding the effects of nonmember conduct, EPA has previously described the Agency's operating approach to require a showing that the potential impacts of regulated activities on the tribe are serious and substantial. 56 FR at 64878. EPA also explained that the activities regulated under the various environmental statutes, including the CWA, generally have serious and substantial potential impacts on human health and welfare. Id. EPA described the Agency's expert assessment regarding the critical importance of water quality management to self-government and also explained that because of the mobile nature of pollutants in surface waters and the relatively small size of water bodies on reservations, it would be very likely that any water quality impairment on non-Indian fee land within a reservation would also impair water quality on tribal lands. Id. at 64878-79. EPA stated that its generalized findings regarding the relationship of water quality to tribal health and welfare would supplement the factual showing tribes would make in applying for TAS. Id. EPA reiterates the generalized statutory and factual findings set forth in those prior TAS rulemakings and believes they apply equally to TAS applications for the CWA Section 303(d) Program. As discussed below, EPA has also separately proposed to revise its interpretation of the CWA tribal provision by conclusively determining that Congress intended to delegate authority to eligible tribes to regulate their entire reservations under the CWA irrespective of land ownership. If and when this revised interpretation is finalized, it will be applied in reviewing any TAS application submitted under the regulations proposed today. Unless and until that revised interpretation is finalized, however, EPA will continue to evaluate TAS applications consistent with the Agency's current approach and will continue to apply the generalized findings set forth in prior CWA TAS rulemakings in making case-by-case determinations regarding tribes' inherent regulatory authority.

In prior CWA TAS promulgations, EPA recognized that there was significant support for the view that Congress had intended to delegate authority to eligible Indian tribes to administer CWA regulatory programs over their entire reservations, irrespective of land ownership, and EPA expressly stated that the issue of tribal authority under the CWA remained open for further consideration in light of additional congressional or judicial guidance. See, e.g., 56 FR at 64878-81. On August 7, 2015, EPA published in the Federal Register a proposed rule to reinterpret the CWA tribal provision as including such an express delegation of authority by Congress. 80 FR 47430. If EPA finalizes that reinterpretation, applicant Indian tribes would no longer be required to demonstrate inherent authority to regulate their reservation waters under the CWA. Among other things, tribes would thus no longer be required to meet the test established in Montana v. United States, 450 U.S. 544 (1981), and its progeny with regard to exercises of inherent tribal regulatory authority over nonmember activity. Id. Instead, a tribe would be able to rely on the congressional delegation of authority included in section 518 of the statute as the source of authority to administer CWA regulatory programs over its entire reservation as part of its legal statement.

The proposed TAS rule for the CWA Section 303(d) Impaired Water Listing and TMDL Program is intended to provide appropriate TAS application and review procedures irrespective of which interpretation of tribal authority under the Act applies. As explained in EPA's proposed reinterpretation, EPA's existing TAS regulations—including 40 CFR 131.8, upon which this proposed rule is modeled—accommodate either interpretation of tribal authority under the CWA and provide appropriate application procedures to ensure that relevant jurisdictional information is provided to EPA and made available for comment. 80 FR 47430. EPA thus proposes to establish the basic TAS application and review procedures proposed today notwithstanding that the proposed reinterpretation remains pending. Once these rules are finalized, EPA will review any TAS applications for the CWA Section 303(d) Program in accordance with the interpretation of CWA tribal jurisdiction that applies at the time.

The fourth criterion would require that the tribe, in the Regional Administrator's judgment, be reasonably expected to be capable of administering an effective CWA Section 303(d) Impaired Water Listing and TMDL Program. To meet this requirement, tribes would either: (1) show that they have the necessary management and technical skills, or (2) submit a plan detailing steps for acquiring the necessary management and technical skills. When considering tribal capability, EPA would also consider whether the tribe can demonstrate the existence of institutions that exercise executive, legislative, and judicial functions, and whether the tribe has a history of successful managerial performance of public health or environmental programs.

The specific information required for tribal applications to EPA is described in proposed § 130.16 (a) and (b). The application would be required, in general, to include a statement regarding federal recognition by DOI, documentation that the tribal governing body is exercising substantial duties and powers, documentation of tribal authority to regulate water quality on the reservation, a narrative statement of tribal capability to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program, and any other information requested by the Regional Administrator.

Consistent with EPA's other TAS regulations, the proposed rule also provides that where a tribe has previously qualified for TAS for purposes of a different EPA program, the tribe is only required to provide information that has not been submitted as part of a prior TAS application. To facilitate review of tribal applications, EPA would request that a tribal application inform EPA whether the tribe has been approved for TAS or deemed eligible to receive authorization for any other EPA program. See 59 FR at 64340.

The TAS application procedures and criteria for the CWA Sections 303(c) WQS and 303(d) Impaired Water Listing and TMDL Programs are similar in many respects, and a tribe interested in both programs may wish to streamline the application process by combining a request for TAS eligibility for 303(c) and 303(d) into a single application. Although a tribe would not be required to do so, EPA's proposed approach would allow a tribe to submit a combined application, which addresses the criteria and application requirements of § 131.8 and proposed § 130.16, to EPA if the tribe is interested in applying for TAS for both the CWA Section 303(c) and 303(d) Programs.

There could be rare instances where special circumstances limit or preclude a particular tribe's ability to be authorized to administer the 303(d) Program over its reservation. For example, there could be a separate federal statute establishing unique jurisdictional arrangements for a specific state or a specific reservation that could affect a tribe's ability to exercise authority under the CWA. It is also possible that provisions in particular treaties or tribal constitutions could limit a tribe's ability to exercise relevant authority.11

The application requirements of § 130.16 (a) and (b) would require tribes to submit a statement of their legal counsel (or equivalent official) describing the basis for their assertion of authority. The statement can include copies of documents such as tribal constitutions, by-laws, charters, executive orders, codes, ordinances, and resolutions. If EPA finalizes this proposed action, the requirement for a legal counsel's statement would ensure that applicant tribes appropriately describe the bases of their authority and address any special circumstances regarding their assertion of authority to administer the 303(d) Program. The proposed rule would provide an appropriate opportunity for “appropriate governmental entities” (i.e., states, tribes and other federal entities located contiguous to the reservation of the applicant tribe) to comment on an applicant tribe's assertion of authority and, among other things, inform EPA of any special circumstances that they believe could affect a tribe's ability to administer the 303(d) Program.

EPA is also aware that section 10211(b) of the Safe, Accountable, Flexible, Efficient Transportation Equity Act of 2005 (“SAFETEA”), Public Law 109-59, 119 Stat. 1144 (August 10, 2005) established a unique TAS requirement with respect to Indian tribes located in the State of Oklahoma. Under section 10211(b) of SAFETEA, tribes in Oklahoma seeking TAS under a statute administered by EPA for the purpose of administering an environmental regulatory program must, in addition to meeting applicable TAS requirements under the relevant EPA-administered environmental statute, enter into a cooperative agreement with the state that is subject to EPA approval and that provides for the tribe and state to jointly plan and administer program requirements. This requirement of SAFETEA applies apart from, and in addition to, existing TAS criteria, including the TAS criteria set forth in section 518 of the CWA. EPA's proposal relates solely to the CWA TAS requirement; it would thus have no effect on the separate requirement of section 10211(b) of SAFETEA.

The proposed EPA review procedure, included in § 130.16(c), specifies that the Regional Administrator, following receipt of tribal applications, would process such applications in a timely manner. EPA would promptly notify the tribe that the complete application has been received. Within 30 days after receipt of a tribe's complete TAS application for 303(d), EPA would provide notice to appropriate governmental entities (i.e., states, tribes, and other federal entities located contiguous to the reservation of the applicant tribe) of the complete application and the substance of and basis for the tribe's assertion of authority over reservation waters, and would provide a 30 day opportunity to comment to EPA on the tribe's assertion of authority. See, e.g., 56 FR at 64844. EPA would also provide, consistent with prior practice, sufficiently broad notice (e.g., through local newspapers, electronic media, or other appropriate media) to inform other potentially interested entities of the applicant tribe's complete application and of the opportunity to provide relevant information regarding the tribe's assertion of authority. As described below, this aspect of EPA's review procedure would apply unless such process would be duplicative of a notice and comment process already performed in connection with the same tribe's prior application for TAS for another CWA regulatory program.

EPA is proposing to include provisions intended to help avoid unnecessary and wasteful duplication of the notice and comment procedures described in VII A. Specifically, EPA proposes that, where a tribe has previously qualified for TAS for a CWA regulatory program12 and EPA has provided notice and an opportunity to comment on the tribe's assertion of authority as part of its review of the prior application, no further notice would be provided with regard to the same tribe's application for the 303(d) Program, unless the section 303(d) TAS application presents different jurisdictional issues or significant new factual or legal information relevant to jurisdiction to the Regional Administrator. Proposed § 130.16(c)(4). This proposed approach would apply to all tribes that have previously obtained TAS for the CWA Section 303(c) WQS Program, CWA Section 402 NPDES Program or Sewage Sludge Management Program, or CWA Section 404 Dredge and Fill Permit Program.

Where different jurisdictional issues or information are not present, additional notice and comment are likely to be duplicative of the process already undertaken during EPA's review of the prior TAS application. Under these circumstances, the proposed rule would avoid such duplication of efforts by authorizing the relevant EPA Regional Administrator to process a TAS application for the 303(d) Program without a second notice and comment process.

Where different jurisdictional issues or new or changed information is present, the notice and comment process described in § 130.16(c)(2) would apply. For example, if the geographic reservation area over which an applicant tribe asserts authority is different from the area covered by a prior TAS application or EPA approval, the process proposed in § 130.16(c)(2) would apply and would provide an appropriate opportunity for comment on the tribe's assertion of authority over the new area. In such circumstances, a tribe may find it appropriate and useful to update its prior TAS application at the same time it applies for TAS for 303(d). This would help ensure that the tribe's TAS eligibility for the various CWA programs covers the same geographic area. Such a combined TAS application would be subject to the § 130.16(c)(2) notice and comment process.

EPA requests comment on its proposed approach or alternative approaches. In addition, we request comment on whether the § 130.16(c)(4) notice and comment exemption should instead be available only prospectively—i.e., only where the applicant tribe obtains TAS for the CWA Section 303(c) WQS Program, CWA Section 402 NPDES Program or Sewage Sludge Management Program, or CWA section 404 Dredge and Fill Permit Program after this proposed rule is finalized (and, again, only if different jurisdictional issues or significant new factual or legal information relevant to jurisdiction are not present in the tribe's 303(d) TAS application). One practical result of this alternative approach would be that if one of the 50 tribes that has previously obtained TAS for the CWA Section 303(c) WQS Program were to apply for TAS for the 303(d) Program after this proposed rule is finalized, the notice and comment process would be required.

Where a tribe's assertion of authority is subject to a competing or conflicting claim, the proposed procedures provide that the Regional Administrator, after due consideration and in consideration of any other comments received, would determine whether the tribe has adequately demonstrated authority to regulate water quality on the reservation for purposes of the 303(d) Program. Where the Regional Administrator concludes that a tribe has not adequately demonstrated its authority with respect to an area in dispute, then tribal assumption of the CWA Section 303(d) Impaired Water Listing and TMDL Program may be restricted accordingly. If a dispute is focused on a limited area, this would not necessarily delay EPA's decision to treat the tribe in a similar manner as a state for non-disputed areas.

This proposed procedure does not imply that states, tribes, other federal agencies, or any other entity have veto power over tribal TAS applications. Rather, it is intended to assist EPA in gathering information that may be relevant to the Agency's determination whether the applicant tribe has the necessary authority to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program. EPA would not rely solely on the assertions of a commenter who challenges a tribe's assertion of authority, but rather make an independent evaluation of the tribal showing.

The proposed rule requires EPA to process a tribe's TAS application in a timely manner, but does not specify a precise time frame for review of tribal TAS applications. Each TAS application will present its own set of legal and factual issues, and EPA anticipates that in some cases it may be necessary to request additional information when examining tribal TAS applications. Similarly, the Agency's experience with states applying for various EPA programs and with tribes applying for TAS for the WQS Program indicates that additional engagement between EPA and the applicant may be necessary before final decisions are made. EPA expects that similar exchanges with tribes will often be helpful and enhance EPA's processing of tribal TAS applications for the CWA Section 303(d) Impaired Water Listing and TMDL Program.

Where the Regional Administrator determines that a tribal TAS application satisfies the requirements of proposed § 130.16(a) and (b), the Regional Administrator would promptly notify the tribe that the tribe has qualified for TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. A decision by the Regional Administrator that a tribe does not meet the requirements for TAS for purposes of the CWA Section 303(d) Impaired Water Listing and TMDL Program would not preclude the tribe from resubmitting the application at a future date. If the Regional Administrator determines that a tribal application is deficient or incomplete, EPA will identify such deficiencies and gaps so the tribe can make changes as appropriate or necessary.

EPA expects that the tribes most likely to be interested in applying for TAS for the 303(d) Program will be those that also have TAS for CWA section 303(c) and have applicable WQS for their reservation waters. EPA has taken final action approving TAS for WQS for 50 tribes. Forty-two of those tribes have EPA-approved WQS, and one tribe without TAS for WQS has federally promulgated WQS.13 By virtue of their involvement in the WQS Program, these tribes will already have demonstrated an interest in directly administering certain fundamental elements of the CWA as well as the resources and capacity to do so. Since applicable WQS are a foundation of the approach to protecting water quality under the CWA, establishing EPA-approved/EPA-promulgated WQS for reservation water bodies will be an important first step for tribes interested in protecting and restoring their reservation waters. As tribes gain experience developing and administering applicable WQS on their reservations, they may become interested in greater involvement in additional programs—such as the 303(d) Program—designed to ensure that applicable WQS are achieved. Obtaining TAS to implement a CWA Section 303(d) Impaired Water Listing and TMDL Program for its reservation waters is one potential next step for interested tribes. Under section 303(d), a tribe would use applicable WQS as the basis for identifying impaired waters and calculating TMDLs, which quantify the maximum amount of a pollutant that a water body can receive and still meet the WQS.

Table 1, below, is an example of one step-wise approach that tribes may follow in developing their water quality programs under the CWA and ultimately seeking TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. This is only one possible approach, and, under this approach, not all the identified steps would need to be taken sequentially (e.g., some could be completed in parallel).

The proposed rule does not require tribes to have applicable WQS in place on their reservations prior to applying for TAS eligibility for the 303(d) Program. Under section 303(d), however, states and authorized tribes must develop lists of impaired waters and TMDLs based on applicable WQS. CWA sections 303(d)(1) and (2). Although EPA expects that the tribes most likely to be interested in administering the 303(d) Program are those that do have such WQS, the proposed rule would not preclude other tribes from obtaining TAS status for section 303(d) purposes and thus ensuring that TAS eligibility requirements are satisfactorily addressed prior to expending resources on developing WQS. This approach would also allow tribes, at their discretion, to streamline and minimize expenditures on TAS procedures by combining TAS requests for sections 303(c) and 303(d) into a single application. Since authorized tribes must list waters and develop TMDLs based on applicable WQS, however, EPA also specifically invites public comment on whether applicable WQS should instead be a prerequisite for obtaining TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program.

The proposed rule also does not require tribes seeking TAS eligibility for the 303(d) Program to have previously obtained EPA approval for TAS for the WQS Program. EPA specifically invites public comment on whether a tribe applying for TAS for the 303(d) Program should instead be required to have already received EPA approval—or at least simultaneously apply—for TAS for CWA Section 303(c) WQS Program.

Pre-proposal input from tribes indicates that resources and funding available for TMDL development will be important considerations for tribes in deciding whether to apply for TAS for CWA section 303(d) purposes. The Impaired Water Listing and TMDL Program is not a grant program, and no federal grant funds are available directly from the Impaired Water Listing and TMDL Program. A tribe may be able to use its General Assistance Program (GAP) Grant under the Indian Environmental General Assistance Program Act to support development of a section 303(d) program and capacity to implement such a program, but GAP funds are not available for ongoing program implementation. Tribes interested in this approach would need to contact their Regional GAP Program coordinator. In addition, existing sources of tribal funding such as CWA section 319 grants and section 106 grants are already tightly constrained and may not be available to support additional work under section 303(d). Some tribes that receive CWA funding may be able to identify program activities that could also support 303(d) activities (e.g., assessing water quality to develop impaired water lists, developing a nonpoint source watershed plan that would also implement the nonpoint source portions of a TMDL), but the availability of such opportunities is uncertain.

As resources allow, EPA may be able to work cooperatively with tribes, as appropriate, on impaired water listing and TMDL issues in Indian country. For example, EPA may develop training and/or provide other technical support to tribes interested in obtaining TAS for 303(d) and implementing a CWA Section 303(d) Impaired Water Listing and TMDL Program if EPA staff and other resources are available to do so. As a general matter, however, EPA cannot assure that funding will be available for a tribe developing or implementing the 303(d) Program, and a tribe considering whether to apply to administer the Program will need to carefully assess its priorities and the availability of EPA assistance or other resources.

Additional information about these statutes and Executive Orders can be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget for review.

EPA has submitted the information collection requirements in this proposed legislative rule to OMB for approval under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR number 2515.01. You can find a copy of the ICR in the docket for this proposed rule, and it is briefly summarized here. If EPA finalizes the proposed rule, this ICR would supplement the current information collection requirements in EPA ICR number 1560.10 (National Water Quality Inventory Reports (Renewal)) and address the tribes' CWA Section 303(d) Impaired Water Listing and TMDL TAS application and 303(d) Program implementation burden, as well as EPA's burden for reviewing the tribes' applications and 303(d) Program submittals. OMB approved the existing ICR number 1560.10 in December 2012.

This proposed legislative rule would establish a process for tribes to obtain TAS for the 303(d) Program. As described in the ICR, EPA estimates the total burden on tribes to apply for TAS for the 303(d) Program would be 3,240 staff hours annually for an estimated 12 tribes that would apply for and receive TAS approval per year.

Tribes that receive TAS approval would then need to implement the requirements of section 303(d) to list impaired waters, set TMDL priorities, and develop TMDLs. EPA estimates that such 303(d) Program implementation burden would entail 86,664 staff hours for the estimated 12 tribes. ICR 1560.10 already includes the estimated burden for states to implement section 303(d), but does not include estimates for tribes. Therefore, the ICR for this proposed rule includes tribal section 303(d) implementation burden as well as the TAS application burden described in the previous paragraph.

As discussed in section V, EPA's regulations require that a tribe seeking to administer a CWA regulatory program must submit information to EPA demonstrating that the tribe meets the statutory criteria described in section V. EPA requires this information in order to determine that the tribe is eligible to administer the program. Similarly, EPA requires the information—in this case, the lists of impaired waters and the TMDLs—from the authorized tribes once they begin implementing the program.

Respondents/affected entities: Any federally recognized tribe with a reservation can potentially apply to administer a regulatory program under the CWA. Tribes with TAS for the 303(d) Program would then implement the Program, as described in section IV.

Respondent's obligation to respond: The information discussed in this proposed rule is required from a tribe only if the tribe seeks and is found eligible to administer a CWA Section 303(d) Impaired Water Listing and TMDL Program. See EPA's proposed regulations cited in section V of this document.

Estimated number of respondents: The total potential pool of respondents is the over 300 tribes with reservations. Although there are 566 federally recognized Indian tribes in the United States, the CWA allows only those tribes with reservations to apply for authority to administer programs. EPA estimates that an average of 12 tribes per year would apply under this proposed rule, and an average of 12 tribes per year would implement the 303(d) Program over the three year period of the ICR.

Frequency of response: Application by a tribe to be eligible to administer the 303(d) Program is a one-time collection of information. Tribes submit impaired water lists to EPA every two years, and submit TMDLs to EPA from time to time as described in section IV of this document.

Total estimated burden: 89,904 tribal staff hours per year for TAS for 303(d) Program application activities and 303(d) Program implementation activities. Burden is defined at 5 CFR 1320.3(b).

This estimate may overstate actual burden because EPA used a conservatively high estimate of the annual rate of tribal applications. This estimate was used to ensure that the ICR does not underestimate tribal burden, given that EPA used a simplifying steady-state assumption in estimating annualized tribal application costs. Also, EPA used conservatively high estimates of 303(d) implementation burden (i.e., 303(d) listing and number of TMDLs that tribes would submit to EPA annually), as further described in the draft ICR number 2515.01.

Total estimated cost: $4,185,269, including staff salaries and the cost of support contractors for an annual average of 12 tribes to apply for TAS and implement the 303(d) Program. This action does not entail capital or operation and maintenance costs.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified in the ADDRESSES section at the beginning of this proposed rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to [email protected], Attention: Desk Officer for EPA. Since OMB is required to make a decision concerning the ICR between 30 and 60 days after receipt, OMB must receive comments no later than February 18, 2016. EPA will respond to any ICR-related comments in the final rule.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. This action affects only Indian tribes that seek TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program.

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

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

This proposed action would only apply to tribal governments that seek eligibility to administer the 303(d) Program. Although it could be of interest to some state governments, it would not apply directly to any state government or to any other entity.

In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and state and local governments, EPA consulted with state associations and representatives of state governments to obtain meaningful and timely input for consideration in this proposal. By letter dated September 19, 2014, EPA invited 10 national and regional state associations to an October 1, 2014, informational meeting at EPA in Washington, DC.14 As a result of this meeting and other outreach, EPA participated in two follow-on meetings with a subset of these associations and their members as well as certain individual states during the month of October 2014. Records of these meetings and copies of written comments and questions submitted by states and state associations are included in the docket for this proposed rule.

Some participants expressed interest in: (1) the nature of comments received from tribes during the pre-proposal tribal consultation and coordination (April 8-June 6, 2014); (2) where they could find the list of tribes having TAS for the WQS Program; (3) whether the TAS process for CWA Section 303(d) Impaired Water Listing and TMDL Program would be consistent with other TAS processes; and (4) whether there is a process in place to consult with states where a tribe applies for TAS for 303(d). Some states also had questions about issues unique to their situations. EPA considered this input in developing the proposed rule, particularly in developing sections V to IX. EPA specifically solicits additional comment on this proposed action from state officials.

This action has tribal implications because it will directly affect tribes interested in administering the CWA Section 303(d) Impaired Water Listing and TMDL Program. However, it would neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. Tribes are not required to administer a 303(d) program. Where a tribe chooses to do so, the proposed rule will provide a regulatory process for the tribe to apply and for EPA to act on the tribe's application.

EPA consulted and coordinated with tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this proposed regulation to permit them to have meaningful and timely input into its development. A summary of that consultation and coordination follows.

EPA initiated a tribal consultation and coordination process for this action by sending a “Notification of Consultation and Coordination” letter on March 28, 2014, to all 566 federally-recognized tribes. The letter invited tribal leaders and designated consultation representative(s) to participate in the tribal consultation and coordination process. EPA held a webinar concerning this matter for tribal representatives on April 29, 2014. A total of 46 tribal representatives participated. Additionally, tribes and tribal organizations sent five comment letters to EPA. Records of this webinar and copies of written comments and questions submitted by tribes and intertribal consortia are included in the docket for this proposed rule.

Tribal comments generally supported EPA's plan to propose a TAS rule for the 303(d) Program. Some comments expressed the need for additional financial and technical support as tribes obtain TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. EPA considered the tribal comments in developing this proposal, and intends to remain sensitive to tribal resource issues in its budgeting and planning process. However, EPA cannot assure or assume that additional funding will be available for a tribe developing or implementing the 303(d) Program. A tribe choosing to administer such programs will need to carefully weigh its priorities and any available EPA assistance as described in section IX above.

EPA specifically solicits additional comment on this proposed action From tribal officials.

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

This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.

This rulemaking does not involve technical standards.

The proposed rule would not have potential to cause disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. This proposed rule would have no direct impacts on human health or the environment. The proposed rule would affect processes and information collection only. The proposed rule would put in place the procedures interested tribes would follow to seek TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program. The action is likely to result in the collection of information or data that could be used to assess potential impacts on the health or environmental conditions in Indian country (see sections III and IV). As described in sections III and IV, above, under CWA section 303(d), authorized tribes would be required to develop lists of impaired waters, submit these lists to EPA, and develop TMDLs for pollutants causing impairments in the waters on the 303(d) lists. TAS for 303(d) would provide authorized tribes the opportunity to participate directly in protecting their reservation waters through the Section 303(d) Impaired Water Listing and TMDL Program, as Congress intended through CWA section 518(e). EPA also expects this proposed rule would advance the goals of the CWA as interested tribes apply for TAS to administer the CWA Section 303(d) Impaired Water Listing and TMDL Program for reservation water bodies.

The action is likely to increase the availability of information to indigenous populations as interested tribes obtain TAS for the CWA Section 303(d) Impaired Water Listing and TMDL Program and begin implementing the Program. In short, tribes with TAS assume the primary role in deciding (1) what waters on their reservations are impaired and in need of restoration, (2) the priority ranking for TMDL development, and (3) what the TMDLs and pollutant source allocations for those waters should look like.

EPA provided meaningful participation opportunities for tribes in the development of this proposed rule, as described in “F. Executive Order 13175: Tribal Consultation and Coordination,” above.

For the reasons stated in the preamble, the U.S. Environmental Protection Agency proposes to amend 40 CFR part 130 as follows:

I. General Information A. Does this action apply to me?

Although this action only applies to the petitioners in question, it is directed to the public in general. Since various individuals or entities may be interested, the Agency has not attempted to describe all the specific entities that may be interested in this action. If you have any questions regarding this action, please consult the person listed at the end of the withdrawal summary for the pesticide petition of interest.

The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2014-0008, is available at http://www.regulations.gov or at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

EPA is announcing the withdrawal of pesticide petitions received under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of tolerances or tolerance exemptions in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities.

Pursuant to 40 CFR 180.7(f), a summary of each of the petitions covered by this document, prepared by the petitioner, was included in a docket EPA created for each rulemaking. The docket for each of the petitions is available online at http://www.regulations.gov.

1. PP 0E7820 (spirodiclofen). EPA issued a notice in the Federal Register of February 4, 2010 (76 FR 17374) (EPA-HQ-OPP-2011-0087), which announced the filing of a pesticide petition (PP 0E7820) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to establish tolerances in 40 CFR part 180 for residues of the insecticide spirodiclofen, 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate, in or on sugar apple, cherimoya, atemoya, custard apple, ilama, soursop, biriba, guava, feijoa, jaboticaba, wax jambu, starfruit, passionfruit, persimmon and acerola at 0.45 ppm; and lychee, longan, Spanish lime, rambutan and pulasan at 3.5 ppm. On April 17, 2014, IR-4 notified EPA that it was withdrawing this petition.

2. PP 9E7632 (spirodiclofen). EPA issued a notice in the Federal Register of February 4, 2010 (75 FR 5790) (EPA-HQ-OPP-2009-0861), which announced the filing of a pesticide petition (PP 9E7632) by Interregional Research Project No. 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to amend the tolerances in 40 CFR 180.608 by revising the tolerance expression under paragraphs (a)(1) and (a)(2) to read as follows: (a)(1). Tolerances are established for residues of the insecticide spirodiclofen, including its metabolites and degradates. Compliance with the tolerance levels specified is to be determined by measuring only spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate). (a)(2). Tolerances are established for residues of the insecticide spirodiclofen, including its metabolites and degradates. Compliance with the tolerance levels specified is to be determined by measuring only the sum of spirodiclofen (3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4,5]dec-3-en-4-yl 2,2-dimethylbutanoate) and its metabolite 3-(2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4,5]dec-3-en-2-one, calculated as the stoichiometric equivalent of spirodiclofen. On April 17, 2014, IR-4 notified EPA that it was withdrawing this petition.

3. PP 4G8247 (flutriafol). EPA issued a notice in the Federal Register of October 24, 2014 (79 FR 63594) (EPA-HQ-OPP-2014-0379), which announced the filing of a pesticide petition (PP 4G8247) by Cheminova, Inc., 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. The petition proposed to establish tolerances in the 40 CFR part 180 for residues of the fungicide flutriafol, (±)-α-(2-fluorophenyl)-α-(4-fluorophenyl)-1 H-1,2,4-triazole-1-ethanol, including its metabolites and degradates, in or on corn, sweet, forage at 5 parts per million (ppm); corn, sweet, kernel plus cob with husks removed at 0.01 ppm; and corn, sweet, stover at 15 ppm. On February 25, 2015, Cheminova, Inc., notified EPA that it was withdrawing this petition.

4. PP 1E7923 (clothianidin). EPA issued a notice in the Federal Register of December 8, 2011 (76 FR 76674) (EPA-HQ-OPP-2011-0860), which announced the filing of a pesticide petition (PP 1E7923) by Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08450. The petition proposed to establish tolerances in 40 CFR part 180 for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on strawberry at 1.4 parts per million (ppm); citrus fruit group 10-10 at 0.5 ppm; citrus, dried pulp at 1 ppm; and pistachio at 0.01 ppm. On April 7, 2015, IR-4 notified EPA that it was withdrawing this petition.

5. PP 3E8226 (gamma-cyhalothrin). EPA issued a notice in the Federal Register of May 23, 2014 (79 FR 29729) (EPA-HQ-OPP-2014-0207), which announced the filing of a pesticide petition (PP 3E8226) by Cheminova A/S, 1600 Wilson Blvd., Suite 700, Arlington, VA 22209-2510. The petition proposed to establish import tolerances in the 40 CFR part 180 for residues of the insecticide gamma-cyhalothrin, in or on fruit, citrus, group 10-10 at 0.07 ppm; citrus, dried pulp at 0.2 ppm; and citrus, oil at 3.5 ppm. On April 8, 2015, Cheminova A/S notified EPA that it was withdrawing this petition.

6. PP 3E8183 (1,3-dichloropropene). EPA issued a notice in the Federal Register of September 12, 2013 (78 FR 56185) (EPA-HQ-OPP-2013-0496), which announced the filing of a pesticide petition (PP 3E8183) by Interregional Research ProjectNumber 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to establish a tolerance in 40 CFR part 180 for the combined residues of the fungicide, cis- and trans-1,3-dichloropropene, including its metabolites and degradates, in or on pineapple at 0.02 ppm. It is proposed that compliance with the tolerance levels specified in § 180.636 is to be determined by measuring cis- and trans-1,3-dichloropropene and its metabolites cis- and trans-3-chloroacrylic acid, and cis-and trans-3-chloroallylalcohol, in or on the commodity. The proposed tolerances are to support post plant use in pineapple, similar to the established drip irrigation use of 1,3-dichloropropene in grapes. On May 20, 2015, IR-4 notified EPA that it was withdrawing this petition.

7. PP 2F8008 (clothianidin). EPA issued a notice in the Federal Register of September 28, 2012 (77 FR 59578) (EPA-HQ-OPP-2010-0217), which announced the filing of a pesticide petition (PP 2F8008) by Valent U.S.A. Corporation, P.O. Box 8025, Walnut Creek, CA 94596. The petition requested to establish tolerances in the 40 CFR part 180 for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruiting, vegetables, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm; and pepper/eggplant subgroup 8-10B at 0.7 ppm. The petition also requested to amend the tolerance in 40 CFR 180.586 (a) by deleting the tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on the vegetable, fruiting group 8 at 0.2 ppm, upon approval of fruiting, vegetables, group 8-10, except pepper/eggplant subgroup 8-10B at 0.2 ppm under “New Tolerance” for PP 2F8008; and replacing the tolerance for residues of the insecticide clothianidin, (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine, in or on fruit, pome at 1.0 ppm with fruit, pome group (11-10) at 1.0 ppm due to the expansion of crop groups. On June 24, 2015, Valent U.S.A. Corporation notified EPA that it was withdrawing this petition.

8. PP 4E8311 (flubendiamide). EPA issued a notice in the Federal Register of March 4, 2015 (80 FR 11611) (EPA-HQ-OPP-2014-0784), which announced the filing of a pesticide petition (PP 4E8311) by Interregional Research Project Number 4 (IR-4), 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition proposed to establish a tolerance in 40 CFR part 180 for residues of the insecticide, flubendiamide, (N2-1,1-dimethyl-2-(methylsulfonyl)ethyl-3-iodo-N1-2-methyl-4-1,2,2,2-tetrafluoro-1-(trifluoromethyl)ethylphenyl-1,2-benzenedicarboxamide) in or on the following: Bushberry subgroup 13-07B at 8.0 ppm; vegetable, fruiting group 8-10 at 0.60 ppm; fruit, pome, group 11-10 at 1.5 ppm; fruit, stone, group 12-12 at 1.6 ppm; nut, tree, group 14-12 at 0.06 ppm; and sunflower, subgroup 20B at 5.0 ppm. Upon the approval of the aforementioned tolerances, the petitioner requests to remove the established tolerances for flubendiamide in or on fruit, pome, group 11 at 1.5 ppm; fruit, stone, group 12 at 1.6 ppm; nut, tree, group 14 at 0.06 ppm; safflower, seed at 5.0 ppm; and sunflower, seed at 5.0 ppm. On September 3, 2015, IR-4 notified EPA that it was withdrawing this petition.

The NPRM is organized as follows:

Interested persons or organizations are invited to participate in this rulemaking by submitting written views, recommendations, and data. Comments are invited on any topic related to this rulemaking.

In addition, HHS/CDC invites comments specifically as to whether there are biological agents or toxins that should be added or removed from the HHS list of select agents and toxins based on the following criteria:

(1) The effect on human health of exposure to the agent or toxin;

(2) The degree of contagiousness of the agent or toxin and the methods by which the agent or toxin is transferred to humans;

(3) The availability and effectiveness of pharmacotherapies and immunizations to treat and prevent any illness resulting from infection by the agent or exposure to the toxin; and

(4) Any other criteria, including the needs of children and other vulnerable populations that the commenter considers appropriate.

HHS/CDC also invites comments on the following questions:

(1) Are there other methods that should be required to validate the rendering of a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious?

(2) Should there be changes to the toxin permissible limits for excluded toxins?

(3) Should Diacetoxyscirpenol (DAS) and T-2 be removed from the select toxin list because they do not have the potential to pose a severe threat to public health and safety?

(4) Does seven calendar days provide a sufficient amount of time for the entity to destroy or transfer the select agents or toxins after identification?

(5) Are there any specific biosafety measures that should be required to prevent laboratory acquired infections (LAIs) or accidental release of the select agents and toxins from an entity into the community?

(6) What alternative regulatory requirement could be constructed such that a registered entity would know whether it had a theft or loss of a select agent or toxin without that registered entity first having “an accurate, current inventory for each select agent . . . held in long term storage”?

Comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure. HHS/CDC will carefully consider all comments submitted in preparation of a final rule.

HHS/CDC is promulgating this rule under the authority of sections 201-204 and 221 of Title II of Public Law 107-188, 116 Stat 637 (42 U.S.C. 262a).

Subtitle A of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, (42 U.S.C. 262a), requires HHS to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to public health and safety (select agents and toxins). Subtitle B of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (which may be cited as the Agricultural Bioterrorism Protection Act of 2002), (7 U.S.C. 8401), requires the United States Department of Agriculture (USDA) to regulate the possession, use, and transfer of biological agents or toxins that have the potential to pose a severe threat to animal or plant health, or animal or plant products (select agents and toxins). Accordingly, HHS and USDA have promulgated regulations requiring individuals or entities that possess, use, or transfer select agents and toxins to register with the CDC or the Animal and Plant Health Inspection Service (APHIS). See 42 CFR part 73, 7 CFR part 331, and 9 CFR part 121 (the select agent regulations). The Federal Select Agent Program (FSAP) is the collaboration of the CDC, Division of Select Agents and Toxins (DSAT) and the APHIS Agriculture Select Agent Services (AgSAS) to administer the select agent regulations in a manner that minimizes the administrative burden on persons subject to the select agent regulations. The FSAP administers the select agent regulations in close coordination with the Federal Bureau of Investigation's Criminal Justice Information Services Division (CJIS).

The Bioterrorism Response Act also requires the HHS Secretary to establish by regulation a list of biological agents and toxins that have the potential to pose a severe threat to public health and safety. In determining whether to include an agent or toxin on the list, the HHS Secretary considers criteria such as the effect on human health of exposure to an agent or toxin; the degree of contagiousness of the agent and the methods by which the agent or toxin is transferred to humans; the availability and effectiveness of pharmacotherapies and immunizations to treat and prevent illnesses resulting from an agent or toxin; and the needs of children and other vulnerable populations. The current list of HHS select agents and toxins can be found at 42 CFR 73.3 (HHS select agents and toxins) and 42 CFR 73.4 (Overlap select agents and toxins). The list of HHS and Overlap select agents and toxins is also available at: http://www.selectagents.gov/SelectAgentsandToxinsList.html.

The HHS Secretary last republished the list of HHS select agents and toxins in the Federal Register on October 5, 2012 (77 FR 61084). The list of HHS select agents and toxins is divided into two sections. The select agents and toxins listed in section 73.3 (HHS select agents and toxins) are those regulated only by HHS under the authority of the Bioterrorism Response Act (42 U.S.C. 262a). The select agents and toxins listed in section 73.4 (Overlap select agents and toxins) are those regulated by HHS under the authority of the Bioterrorism Response Act and also regulated by the U.S. Department of Agriculture under the authority of the Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401).

The Bioterrorism Response Act requires the HHS Secretary to review and republish the list of select agents and toxins on at least a biennial basis. Using government subject matter experts, HHS/CDC conducts the biennial review process in consultation with the HHS/CDC Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC). The ISATTAC is comprised of Federal government employees from CDC, Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response, the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the Department of Homeland Security (DHS), the Department of Defense (DOD), the USDA/Animal and Plant Health Inspection Service (APHIS), USDA/Agricultural Research Service (ARS), and USDA Center for Veterinary Biologics (CVB). Based on the criteria outlined in the Bioterrorism Response Act, the ISATTAC considered the following criteria in their review of the HHS and Overlap lists of select agents and toxins: The degree of pathogenicity (ability of an organism to cause disease), communicability (ability to spread from infected to susceptible hosts), ease of dissemination, route of exposure, environmental stability, ease of production in the laboratory, ability to genetically manipulate or alter, long-term health effects, acute morbidity (illness), mortality, available treatment, status of host immunity, vulnerability of special populations, and the burden or impact on the health care system.

On February 27, 2015, HHS/CDC published an advance notice of proposed rulemaking (80 FR 10656) in which we requested public comment on (1) whether there are biological agents or toxins that should be added or removed from the HHS list of select agents and toxins; and (2) whether HHS/CDC should remove the following six select agents from the HHS list of select agents and toxins: Coxiella burnetti, Rickettsia prowazekii, Bacillus anthracis Pasteur strain, Brucella abortus, Brucella melitensis, and Brucella suis.

The following changes to the list of HHS select agents and toxins are proposed based on comments received to the advance notice of proposed rulemaking (80 FR 10656) referenced above, recommendations from the ISATTAC, information from the DHS Material Threat Determinations (DHS-MTD) of biological agents and toxins (https://www.medicalcountermeasures.gov/phemce/dhs.aspx), and the expertise of federal agencies and staff responsible for the oversight of the possession, use, and transfer of select agents and toxins. We are also proposing specific changes to the current regulations, as discussed below, addressing biosafety; clarifying regulatory language concerning security, training, incident response, and records; correcting an omission from the technical amendment (appeal process for exclusion); and revision of the select agent list with current taxonomic names.

We are proposing to add two new terms to section 73.1 (Definitions) of the regulations. We are proposing to define the term “Inactivation” as “a method to render a select agent non-viable but retain characteristic of interest for future use, or to render any nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use.” We are also proposing to define the term “Kill curve” as “the results of a dose-response experiment where a select agent is subjected to increasing amounts of the inactivating treatment to determine the minimum conditions required to render it non-viable or to render any nucleic acids that can produce infectious forms of any select agent virus as non-infectious.” The new definitions will help clarify proposed regulatory language in section 73.12 (Biosafety).

On February 27, 2015, HHS/CDC published an advance notice of proposed rulemaking (ANPRM) (80 FR 10656) in which we requested public comment specifically on whether there are biological agents or toxins that should be added or removed from the HHS list of select agents and toxins.

In that same docket, HHS/CDC also requested public comments as to whether biological agents specifically listed in the February 27, 2015 ANPRM should be removed or remain on the list. The listed agents were Coxiella burnetti, Rickettsia prowazekii, Bacillus anthracis Pasteur strain, Brucella abortus, Brucella melitensis, and Brucella suis. We are now proposing that these agents be removed from the HHS list of select agents based on the twenty-two comments received in response to the February 27, 2015 ANPRM, recommendations from the ISATTAC, and our review of current scientific data regarding these biological agents.

In response to the February 27, 2015 ANPRM, we received 11 comments concerning Coxiella burnetii. Only two commenters recommended that C. burnetii remain on the list because “antibiotic treatment should not be considered for removing the agent.” The other nine commenters argued that C. burnetii should not be included as a select agent based on the following assertions:

• Five commenters stated it is not easily transmitted from person to person.

• Three commenters referenced that even in the absence of antibiotic treatment, Q fever (the disease with acute and chronic stages caused by the bacteria C. burnetii) is generally a self-limited flu-like illness with low mortality (Ref. 1).

• All commenters acknowledged that most infections are inapparent and most seropositive individuals cannot remember an infection consistent with Q fever.

• Six commenters agreed that Coxiella is susceptible to a number of readily available antibiotics. Preferred treatments include tetracycline or doxycycline. Quinolones have also been used successfully and Co-trimoxazole is recommended in specific situations such as pregnancy.

The ISATTAC recommended the removal of C. burnetii from the HHS list of select agents and toxins because:

• It has a low mortality rate with antibiotic treatment and most seropositive individuals cannot remember an infection consistent with Q fever (Ref. 2); and

• A whole-cell killed vaccine (Q-Vax) with nearly 100% efficacy is licensed in Australia and has been used to vaccinate U.S. researchers whom were at risk (Ref. 3).

We are now proposing to remove C. burnetii from the HHS list of select agents (42 CFR 73.3). As discussed above, our proposal is supported by comments we received in response to the February 27, 2015 ANPRM and the recommendations of the ISATTAC. Both the commenters and the ISATTAC supported their recommendations with the scientific references noted above. We further conclude that, based on recent information provided by DHS-MTD, C. burnetii does not pose a severe threat to public health and safety. We are, however, still seeking comment from those who may believe that C. burnetii remains a severe threat to public health and safety and accordingly should be retained as a HHS select agent.

In response to the February 27, 2015 ANPRM, we received eight comments concerning Rickettsia prowazekii. Only one commenter recommended to retain Rickettsia prowazekii because “antibiotic treatment should not be considered for removing the agent.” The other seven commenters supported removal based on the following reasons:

• The risk of mass casualties is low because R. prowazekii can be treated with a single dose of doxycycline when symptoms are present;

• Transmissibility from person to person is low due to the fact that R. prowazekii is usually transmitted via blood, although it can be spread through inhalation of louse feces;

• The agent has poor environmental stability; and

• The difficulty in growing and purifying substantial quantities of these agents in vitro.

The ISATTAC recommended the removal of R. prowazekii from the HHS list of select agents and toxins because:

• It is treatable with available antibiotics (Ref. 4 and 5);

• The risk of mass casualties is low because R. prowazekii can be treated with a single dose of doxycycline when symptoms are present (Ref. 4 and 5); and

• Transmissibility from person to person is low due to the fact that R. prowazekii is usually transmitted via blood, although it can be spread through inhalation of louse feces (Ref. 5).

We are now proposing to remove R. prowazekii from the HHS list of select agents (42 CFR 73.3). As discussed above, our proposal is supported by the comments we received in response to the February 27, 2015 ANPRM and the recommendations of the ISATTAC. Both the commenters and the ISATTAC supported their recommendations with the scientific references noted above. We further conclude that, based on recent information provided by DHS-MTD, R. prowazekii does not pose a severe threat to public health and safety. We are, however, still seeking comment from those who may believe that R. prowazekii remains a severe threat to public health and safety and accordingly should be retained as a HHS select agent.

We received six comments to the February 27, 2015 ANPRM with all commenters agreeing that Bacillus anthracis Pasteur strain should not be included as a select agent based on B. anthracis Pasteur strain lacks the plasmid that encodes the toxin genes causing disease. The B. anthracis Sterne strain, which lacks the plasmid that encodes for the capsule, was excluded from the requirements of the regulations effective on February 27, 2003.

The ISATTAC recommended the removal of B. anthracis Pasteur strain from the overlap list of select agents and toxins because:

• B. anthracis Pasteur strain lacks the plasmid that encodes the toxin genes causing disease (Ref. 6);

• B. anthracis Sterne strain, which lacks the plasmid that encodes for the capsule, was excluded from the requirements of the regulations effective on February 27, 2003 (Ref. 7-8); and

• Historically, the B. anthracis Pasteur strain has been retained as a select agent to allow for continued oversight of laboratories in which the accidental (or intentional) combination of this strain with the Sterne strain could occur to produce de novo the wild type phenotype B. anthracis. However, a recent study indicates that bacterial transformation of B. subtilis with plasmid DNA is inefficient; indicating that transformation with plasmid pXO1 into closely related bacteria such as the Bacillus anthracis Pasteur strain would also be inefficient (Ref. 9).

We agreed with the commenters and ISATTAC. We propose to remove B. anthracis Pasteur strain because the transformation of a virulence plasmid from one Bacillus strain to another is difficult.

Responses were received from 16 commenters to the February 27, 2015 ANPRM, that addressed the retention of the three Brucella species (B. abortus, B. melitensis, and B. suis) currently on the overlap select agent list. Only two commenters recommended to retain these species because “antibiotic treatment should not be considered for removing the agent.” The other 14 commenters supported removal based on the rationale provided in the ANPRM.

The ISATTAC recommended the removal of B. abortus, B. melitensis, and B. suis from the overlap list of select agents and toxins because:

• B. abortus has a low human mortality rate (Ref. 10);

• B. abortus, B. melitensis, and B. suis are treatable with antibiotics (Ref. 10); and

• Human-to-human transmission is extremely rare, and wildlife carriers in the United States often come into contact with humans without significant transmission (Ref. 10).

We agreed with the commenters and ISATTAC. We propose to remove B. abortus, B. melitensis, and B. suis because although Brucella has a low infectious dose, it is treated, mortality is low, efficacy of treatment is good for all three Brucella strains.

We are proposing to add specific requirements to the biosafety section of the regulations (42 CFR 73.12) to address the requirements for rendering a select agent or an nucleic acids that can produce infectious forms of any select agent virus “non-viable.”

Sections 73.3 (HHS select agents and toxins) and 73.4 (Overlap select agents and toxins) both provide that a “non-viable” select agent is excluded from the requirements of the select agent regulations. We are proposing that for an agent to be “non-viable,” or to render a nucleic acids that can produce infectious forms of any select agent virus non-infectious for future use, an entity must use a validated method. A validated method means that the method must be scientifically sound such that method will produce consistent results each time the method is used. As outlined in our guidance for “Non-viable Select Agents and Nonfunctional Select Toxins and Rendering Samples Free of Select Agents and Toxins” (http://www.selectagents.gov/guidance-nonviable.html), an inactivation procedure may include (1) use of the exact conditions of an accepted method that has been validated, such as autoclaving, (2) a published method with adherence to the exact published conditions, or (3) for in-house methods, validation testing should include the specific conditions used and appropriate controls.

As part of the inactivation procedure, an entity would be required to develop a site specific kill curve to identify conditions of inactivation for each select agent or regulated nucleic acids that can produce infectious forms of any select agent virus. If there are strain-to-strain variations in resistance of a select agent to the inactivation procedure, then a specific kill curve would be required to be developed for each strain that undergoes the inactivation procedure. A new kill curve would also be required to be created upon any change in procedure or inactivation equipment. In addition, a validated sterility testing protocol to ensure that the inactivation method has rendered a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious would be required to be conducted.9ij

We are also proposing that written records be kept for a select agent or extracts that have been subjected to a procedure to render them non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus that have been subjected to a procedure to render them non-infectious.

We are also soliciting ideas as to whether there are other methods that should be required to validate the rendering of a select agent non-viable or regulated nucleic acids that can produce infectious forms of any select agent virus non-infectious.

Section 73.3(d)(3) of the select agent regulations (42 CFR 73.(d)(3))specifies the select toxin amounts under the control of a principal investigator, treating physician or veterinarian, or commercial manufacturer or distributor that are excluded from the requirements of the select agent regulations. However, this exclusion applies to the transfer of select toxins “only after the transferor uses due diligence and documents that the recipient has a legitimate need . . . to handle or use such toxins” (42 CFR 73.3(d)(3)(i)). This provision was added to the select agent regulations to address the concern that someone might be able to covertly stockpile toxins by receiving multiple orders below the excluded amount. The toxin “due diligence” provision requires a person transferring toxins in amounts which would otherwise be excluded from the provisions to: (1) Use due diligence to assure that the recipient has a legitimate need to handle or use such toxins; and (2) report to the FSAP if they detect a known or suspected violation of Federal law or become aware of suspicious activity related to the toxin.

“Due diligence” is generally understood to be such a measure of prudence, activity, or assiduity, as is properly to be expected from, and ordinarily exercised by, a reasonable and prudent person under the particular circumstances; not measured by any absolute standard, but depending on the relative facts of the specific case.

We are proposing to add a more specific documentation requirement to the toxin exclusion provision to require the transferor to document the identity of the recipient and the legitimate need (i.e., prophylactic, protective, bona fide research, or other peaceful purpose) claimed by the transferee. Information required to be documented would also include the name of the toxin and the total amount transferred. Identity information of the person requesting and using the toxins would include the individual's name, institution name, address, telephone number, and email address.

In conjunction with this biennial review, the FSAP solicited input from biological toxin subject matter experts to review the listed exclusion limits for select toxins in the HHS select agent regulations. To assess the amount necessary to weaponize a biological toxin, DHS developed toxin parameters and attack scenarios for potential inhalation and ingestion exposures to select toxins. DHS used the formulas described below to estimate ingestion scenarios while employing the “NIST CONTAM Multizone Modeling” software (http://www.bfrl.nist.gov/IAQanalysis/) for inhalation scenarios. To estimate the amount of toxin for each scenario, DHS analyzed a range of release sizes (in mg) for each biological toxin in order to estimate the number of people that would be exposed to LD-50 (lethal dose, 50% or median lethal dose, the amount of the substance required (usually per body weight) to kill 50% of the test population); or TD-50 (the median toxic dose of a toxin is the dose at which toxicity occurs in 50% of cases) levels of each toxin amount by ingestion of milk (using published TD-50 or LD-50) and/or indoor inhalation (using published LD-50). The inhalation models analyzed toxin releases in three different indoor public facilities that experience heavy commuter volume (population details for these facilities are given in Table 1). One hundred scenarios were generated for each facility using 1-10µm particle sizes. The models used 10 random locations within each facility (potential release locations and population evenly spaced throughout occupied area) at 10 random times. The inhalation models assumed:

• No immediate symptoms, so no changes in population movement due to attack

• Respiration rate 10L/min

• All people assumed to have the same mass = 70 kg (e.g., did not account for lower doses required for children)

The ingestion models investigated biological toxins introduced into a fluid (e.g., milk) that was purchased and consumed by consumers over a two day period. Production details and specifics of how the toxins were introduced were not considered. In particular, the largest scenarios involve contaminating greater than ten million servings, which was determined to be implausible in practice. The ingestion models made the following assumptions:

• Milk containing specified quantity of active toxin (1 mg to 1 kg) reaches store shelves.

• Milk is consumed over six days at a uniform rate.

• Contaminated milk is consumed daily until supply is depleted or a health advisory is issued.

• Milk contamination discovered and health advisory issued a minimum of one day, and a maximum of >1 week post attack (at which point all contaminated milk has been consumed).

• For toxins other than saxitoxin and tetrodotoxin, the attacker chooses a toxin concentration such that a person in the 45+ years old age group will consume 1 LD-50 (or TD-50) over 6 day consumption period.

• Since saxitoxin and tetrodotoxin are largely excreted in approximately one day after consumption, the attacker chooses a saxitoxin or tetrodotoxin concentration such that a person in the 45+ years old age group will consume 1 LD-50 (or TD-50) over a one day consumption period.

• Total volume of milk contaminated equals the number of grams of toxin available divided by the toxin concentration (i.e., total volume of milk contaminated depends on the mass of toxin assumed to be available (which varies from 1 mg to 1 kg) and the toxin ingestion LD-50 (or TD-50)).

• If the toxin ingestion LD-50 (or TD-50) is given by a range, the geometric mean of this range is used.

• Range of total volumes of milk contaminated is less than 1 L to approximately 108 L.

• The amount of milk contaminated is assumed to depend on how much toxin the attacker has available (i.e., the total volume of milk contaminated equals the number of grams of toxin available divided by the toxin concentration). For example, for a 1 g attack, with a toxin that has an LD-50 of 1mg/kg, the volume of milk contaminated would be 1000 mg/(0.056 mg/mL*1000 mL/L) = 18 L of milk.

• For small attack sizes, it is assumed the attacker would target appropriately-sized small holding tanks or containers, while for large attack sizes, the attacker would target large holding tanks or silos.

• If the toxin is degraded due to pasteurization or storage, the amount of toxin introduced pre-processing would have to be correspondingly larger than these masses.

Based on the data generated by the models described above, we are proposing the following exclusion limits based on the amounts estimated to expose less than 10 people by inhalation or less than 100 people by ingestion to the LD-50 or TD-50 levels of toxin:

• Increase the regulatory exclusion limit of Botulinum neurotoxin (BoNT) from 0.5 mg to 1 mg;

• Increase the regulatory exclusion limit of Staphylococcal enterotoxins from 5 mg to 100 mg;

• Increase the regulatory exclusion limit of saxitoxin from 100 mg to 500 mg;

• Increase the regulatory exclusion limit of tetrodotoxin from 100 mg to 500 mg;

• Increase the regulatory exclusion limit of abrin from 100 mg to 1,000 mg;

• Increase the regulatory exclusion limit of ricin from 100 mg to 1,000 mg; and

• Increase the regulatory exclusion limit of DAS from 1,000 mg to 10,000 mg.

• Increase the regulatory exclusion limit of T-2 from 1,000 mg to 10,000 mg.

We are, however, still seeking comment from those who may believe that we should retain the current exclusion limits. In addition, we are interested in receiving comments from the public on whether DAS and T-2 have the potential to pose a severe threat to public health and safety or whether these two toxins should be removed from the select toxin list given the high exclusion limit for DAS and T-2.

We are proposing short, paralytic alpha-conotoxins containing the following amino acid sequence (X1CCX2PACGX3X4X5X6CX7) be removed as a select toxin for the following reasons:

• The DHS model reported LD-50 value for inhalation delivery of alpha-conotoxin is 20 µg/kg, which is a low toxicity compared to other select toxins;

• A regulatory exclusion limit of 10,000 mg would require the depletion of the cone snail population to achieve this quantity.

Therefore, based on the low toxicity of short, paralytic alpha-conotoxins and the high dosage required for inhalation exposure, we are proposing that the alpha-conotoxin be removed from the select toxin list (Ref. 32).

Original food samples and clinical samples are those specimens that are submitted to laboratories for diagnosis or verification purposes to identify or verify a biological agent or toxin. For example, an original food sample could be a container of potato salad or juice. An original clinical sample could be serum or stool from a patient. Laboratories that test food sample and clinical samples for the presence of toxins generally do not know the level of toxin in a sample and do not extract and purify a toxin as part of their studies. Therefore, we are proposing to exclude the original food sample or clinical sample identified to contain an HHS select toxin to be consistent with the rationale for the current exclusion for animals exposed to toxins (42 CFR 73.3(d)(4)). The proposed exclusion is based upon input from biological toxin subject matter experts and our determination that quantifying the amount of toxin in these samples is problematic because (1) the amount of toxin is highly variable, which would require large amounts of food and clinical samples to quantify or purify, (2) laboratory procedures to extract toxin from samples are inefficient with most extractions producing low yields; (3) the resources that would be required to quantify toxins in clinical samples and food samples make sample quantification prohibitively expensive; and (4) procedures in these laboratories, based on the requirements of their public health mission, are designed only for toxin detection and not for purification and quantification. Therefore, we are interested in comments regarding our rationale that the original food sample or clinical sample identified to contain an HHS select toxin should be excluded from the select agent regulation.

Laboratories that are only registered for BoNT-producing species of Clostridium do not normally have a need to account for BoNT produced during the culturing of Clostridium since studying the toxin is not part of their work objective. Therefore, we propose to exclude toxins that are produced only as a byproduct to a study of the toxin producing host organism so long as the toxin has not been intentionally collected, purified, or otherwise extracted, and the material containing the toxin is inactivated and properly disposed of within 30 days of the initiation of the culture. The 30 day disposal time was recommended by biological toxin subject matter experts based on the time it would take to grow the organism and perform the extraction process. This exclusion allows laboratories whose purpose does not include purification of the toxin to more effectively conduct outbreak investigations, food studies, and molecular characterization of agents which produce toxin. In the case of BoNT, these laboratories would still be regulated for the BoNT-producing species of Clostridium and in the case of all other HHS select toxins the laboratories would be regulated if they wished to keep the material containing toxins for longer than 30 days from the initiation of culture of the toxin producing host organism. If at any time an entity manipulated the material that contains the select toxin, such as intentional collection, purification or extraction of the toxin from culture supernatant, such activities would void this exemption, and the entity would be required to be registered for the select toxin and meet all applicable select agent and toxin regulatory requirements.

Since a registered or certified reference laboratory typically confirms the identification of a select agent or toxin for public health and agriculture, clinical and diagnostic laboratories, we are proposing to require the registered or certified reference laboratory inform the specimen provider of the identification. This will ensure that the reference laboratory notifies the specimen provider of the identification of the select agent or toxin so that the specimen provider is aware that they are in possession of the agent or toxin and must meet the requirements outlined in 42 CFR 73.5, 73.6.

Once a clinical or diagnostic laboratory has identified a select toxin-positive specimen, an APHIS/CDC Form 4 (Report of the Identification of a Select Agent or Toxin) must be submitted to the FSAP. The select agent regulations currently require the laboratory to transfer or destroy the material within seven days of identification (42 CFR 73.5(a), 73.6(a)) because we determined through input from technical experts that the seven calendar days provides a sufficient amount of time for the entity to destroy or transfer the select agents or toxins after identification. In the past, we have received comments that argued that the seven day requirement for transferring or destroying select agents or toxins used for diagnosis or testing is too short a time limit. Therefore, we are seeking comments to determine if seven calendar days provides a sufficient amount of time for the entity to destroy or transfer the select agents or toxins after identification.

In addition, we are seeking comments to extend the exemption time period to 30 days for BoNT and Staphylococcal enterotoxin (Subtypes A-E) to allow clinical and diagnostic laboratories sufficient time to complete their investigations without having to transfer or destroy the sample. Laboratories would still be required to report the identification of BoNT immediately and Staphylococcal enterotoxin (Subtypes A-E) within seven days. We are proposing to amend the language in 42 CFR 73.5(a), and 42 CFR 73.6(a)to read: “Unless directed otherwise by the HHS Secretary, within seven calendar days after identification of the select agent and toxin (except for Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E)), or within thirty calendar days after identification of Botulinum neurotoxin and/or Staphylococcal enterotoxin (Subtypes A-E), the select agent or toxin is transferred in accordance with § 73.16 or destroyed on-site by a recognized sterilization or inactivation process,”

To clarify how the select agent regulations apply to activities associated with the diagnosis and care for individuals infected with a select agent or exposure to a select toxin, we are proposing to add provisions that HHS/CDC will not regulate material containing a select agent or toxin when it is in a patient care setting and is not being otherwise collected, tested or retained for non-patient care purposes. However, once delivery of patient care for an illness associated with a select agent or toxin has concluded these specimens would become subject to the regulatory requirements. An entity unable to meet all of the regulatory requirements necessary to retain the material will then have the option of transferring the material containing the select agent or toxin in accord with the select agent regulations or destroying the materials within seven calendar days of the conclusion of patient care.

We also are proposing to clarify that FSAP does not regulate waste generated during the delivery of patient care.

We are codifying in regulations the current FSAP policy that an entity is required to meet all of the regulatory requirements for those select agents and toxins listed on the entity's registration regardless of whether the select agent or toxin is in the actual possession of the entity; and without regard to the actual amounts of toxins in the possession of the entity.

Section 73.9(a)(6) of the select agent regulations currently states that the Responsible Official must ensure that an annual inspection is conducted for each laboratory where select agents and toxins are stored or used. This requirement also provides that the results of each inspection must be documented, and any deficiencies identified during an inspection must be corrected. We are adding a requirement that the Responsible Official must also document the corrective actions taken by the entity to address any identified deficiencies.

In response to a recommendation in the December 2014 Federal Experts Security Advisory Panel report, we are adding a requirement that the Responsible Official must ensure that individuals are provided the contact information of the HHS or USDA Office of Inspector General Hotline so that individuals are able to anonymously report a safety or security concern related to select agents and toxins. In its December 2014 report, the Federal Experts Security Advisory Panel recommended adding a specific requirement to include how individuals are informed so that they can access the HHS or USDA Office of Inspector General Hotline to anonymously report a safety or security concern.

Section 73.10(e) of the select agent regulations currently provides that a person with a valid approval from the HHS Secretary or APHIS Administrator to have access to select agents and toxins may request, through his or her Responsible Official, that the HHS Secretary or APHIS Administrator provide their approved access status to another registered individual or entity for a specified period of time. This allows a scientist registered to work with a select agent at a registered entity to work with the select agent at another registered entity. To ensure that the Responsible Official of the entity hosting the visitor is aware if a visiting individual loses approval for access to select agents and toxins, we are proposing to add a requirement that the Responsible Official at the home entity must immediately notify the Responsible Official of the visiting entity if the person's access to select agents or toxins has been terminated.

The select agent regulations require a registered entity to develop and implement a number of plans in order to ensure the safety and security of the select agents they handle. These are:

• A security plan that provides for measures sufficient to safeguard the select agent or toxin against unauthorized access, theft, loss, or release (42 CFR 73.11);

• A biosafety plan that provides for measures sufficient to contain the select agent or toxin (e.g., physical structure and features of the entity, and operational and procedural safeguards) (42 CFR 73.12); and

• An incident response plan that provides for measures that the registered entity will implement in the event of theft, loss, or release of a select agent or toxin; inventory discrepancies; security breaches (including information systems); severe weather and other natural disasters; workplace violence; bomb threats and suspicious packages; and emergencies such as fire, gas leak, explosion, power outage, etc. The response procedures must account for hazards associated with the select agent or toxin and appropriate actions to contain such agent or toxin. (42 CFR 73.14)

Drills or exercises must be conducted at least annually to test and evaluate the effectiveness of the plans. The plans must be reviewed and revised, as necessary, after any drill or exercise and after any incident. We are proposing to require that these drills or exercises be documented to include how the drill or exercise tested and evaluated the plan, any problems identified and corrective actions that were taken, and the names of the individuals who participated in the drill or exercise. This will provide a more thorough accounting of required activities via testing and entity-directed improvements.

Similar to the existing requirement for the security plan, we are also proposing to add a requirement that the biosafety and incident response plans be submitted for initial registration, renewal of registration, or when requested by FSAP.

We are proposing to amend the regulatory language in section 73.12 to update the name change of the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (Ref. 31).

Prior to the publication of the 5th edition of CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (Ref. 3), the Occupational Safety and Health Administration (OSHA) regulations in 29 CFR 1910.1200 and 1910.1450 provided specific requirements for handling hazardous chemicals in the laboratories. This regulation also provided recommendations for safely working with chemical including toxins and gave non-mandatory recommendations for prudent practices in laboratories handling chemical hazards. As such, we included this reference for entities to consider when developing biosafety plans for those facilities working with toxins. Since the current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories Appendix I provides guidelines for work with toxins of biological origin, we have removed the reference to the OSHA regulations in 29 CFR 1910.1200 and 1910.1450. It should be noted that regulated entities must still meet the OSHA regulatory requirements where applicable.

In addition, we want to ensure that laboratory personnel that are working with select agents and toxins are aware of the risks associated with these agents. As such, we are proposing to add a requirement that a laboratory-specific biosafety manual must be accessible to individuals. This is consistent with guidance provided by the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories. This requirement is proposed to foster an enhanced culture of responsibility by ensuring that appropriate biosafety resources are available to all staff with access to select agents and toxins within a select agent laboratory.

The current regulations require that the biosafety plan be written using performance standards. In the aftermath of recent biosafety incidents involving select agents, we are proposing that the biosafety plan should be designed according to a site-specific risk assessment in accordance with the risk of a select agent, given its intended use by adding specific provisions to the biosafety section that would require a written risk assessment for each registered select agent or toxin; written safety procedures to protect entity personnel, the public, and the environment from exposure to the select agent or toxin; written decontamination procedures; and written waste management procedures.

The FSAP would also like to solicit ideas regarding any specific biosafety measures that should be required to prevent LAIs or accidental or intentional release of the select agents and toxins from an entity into the community.

We are proposing to amend the requirement that the security plan contain a description of how the entity authorizes the means of entry into areas where select agents or toxins are stored or used, to include a requirement that the security plan must include a description of centralized access control management systems (e.g., keycards) and/or key management (mechanical keys).

Paragraphs (d)(7)(i) through (d)(7)(v) of section 11 of the select agent regulations encompass a list of events that individuals with access approval from the APHIS Administrator or the HHS Secretary must immediately report to the Responsible Official. We are proposing to add a new requirement that the Responsible Official must be notified of any loss of computer, hard drive, or other data storage device containing information that could be used to gain access to select agents or toxins. We believe that such notification will facilitate notification of the Federal Bureau of Investigation if deemed necessary by the Responsible Official as the loss of such equipment may be criminal in nature.

We are proposing to amend section 15 of the select agent regulations which concerns the provision of training for staff and visitors who work in or visit areas where select agents or toxins are handled or stored. Since individuals need to understand hazards associated with the select agents and toxins that they will be working with in the laboratory or are in the area they will be visiting, we are proposing to require that all individuals who have received approval to have access to select agents and toxins have training that address the particular needs of the individual and the risks posed by the select agent or toxin regardless of whether they have access to the select agents or toxins. The training would have to be completed within 12 months of that individual's anniversary of receiving access approval or prior to his or her entry into an area where any select agents and toxins are used or stored, whichever occurs first. This change is necessary in order to codify our policy regarding which individuals at registered entities are required to receive training.

We are also proposing to add a new paragraph (e) to section 15, which would require the entity's Responsible Official to provide contact information for the USDA or HHS Office of the Inspector General Hotline. Details of the proposed addition may be found under the heading “Responsible Official.”

Based on inspections of registered entities, we observed that entities are maintaining records of the destruction of select agents even though section 73.17 of the select agent regulations currently does not include a requirement for documenting when a select agent is destroyed. To ensure the proper tracking of a select agent from acquisition to destruction and to incorporate into the regulations what entities are currently doing, we are proposing to add the requirement for records to be created and maintained for the destruction of a select agent held in long-term storage to include the quantity (i.e., number of vials) of select agent destroyed, the date of such action, and by whom.

Section 73.17 of the select agent regulations currently states that records and databases need to be accurate. To ensure that handwritten records are accurate, we are proposing to clarify that hand-written record must be legible (i.e., capable of being read).

We are proposing to expand the scope of records required to be maintained to include any records that contain information related to the requirements of the regulations. Such records may include, but would not limited to, biocontainment certifications, laboratory notebooks, institutional biosafety and/or animal use committee minutes and approved protocols, and records associated with occupational health and suitability programs. We propose revision to the regulations will enhance the ability of FSAP to evaluate biosafety, security, and incident response programs and includes any record created under sections 73.5, 73.7, 73.9, 73.11, 73.12, 73.14, 73.15, 73.16, 73.17, and 73.19 of the select agent regulations.

The FSAP continues to receive comments that are critical of that portion of the select agent regulations that require a registered entity to maintain “an accurate, current inventory for each select agent . . . held in long term storage.” The comments typically focus on the belief that a container based inventory requirement is not useful to track inventory of biological agents of which small amounts of samples from the container could be stolen without detection and used to grow larger quantities. In the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Congress requires the Secretaries of Health and Human Services and Agriculture to include in the select agent regulations a requirement for “the prompt notification of the Secretary, and appropriate Federal, State, and local law enforcement agencies, of the theft or loss of listed agents and toxins.” HHS/CDC is soliciting ideas on any alternative regulatory requirement that could be constructed such that a registered entity would know whether it had a theft or loss of a select agent or toxin without that registered entity first having “an accurate, current inventory for each select agent . . . held in long term storage.”

Under Executive Order 12866 (EO 12866), Regulatory Planning and Review (58 FR 51735, October 4, 1993) HHS/CDC is required to determine whether this regulatory action would be “significant” and therefore subject to review by the Office of Management and Budget (OMB) and the requirements of the Executive Orders. This order defines “significant regulatory action” as any regulatory action that is likely to result in a rule that may:

• 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;

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

• Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients; or,

• Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in EO 12866.

Executive Order 13563 (EO 13563), Improving Regulation and Regulatory Review, (76 FR 3821, January 21, 2011), updates some of the provisions of EO 12866 in order to promote more streamlined regulatory actions. This EO charges, in part, that, while protecting “public health, welfare, safety, and our environment” that regulations must also “promote predictability and reduce uncertainty” in order to promote economic growth. Further, regulations must be written in plain language and be easy to understand.

HHS/CDC has determined that this NPRM is a significant regulatory action as defined in EO 12866. However, the Office of Management and Budget has waived their review of the document.

We have examined the impacts of the proposed rule under the Regulatory Flexibility Act (5 U.S.C. 601-612). Unless we certify that the proposed rule is not expected to have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. We certify that this proposed rule will not have a significant economic impact on a substantial number of small entities within the meaning of the RFA.

This regulatory action is not a major rule as defined by Sec. 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This proposed rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in cost or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), HHS/CDC has determined that the Paperwork Reduction Act does apply to information collection and recordkeeping requirements included in this rule. We note that the information collection and recordkeeping requirements are already approved by the Office of Management and Budget (OMB) under OMB Control Number 0920-0576.

This rule has been reviewed under E.O. 12988, Civil Justice Reform. Once the final rule is in effect, HHS/CDC notes that: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) No retroactive effect will be given to this rule; and (3) Administrative proceedings will not be required before parties may file suit in court challenging this rule.

HHS/CDC has reviewed this proposed rule in accordance with Executive Order 13132 regarding Federalism, and has determined that it does not have “federalism implications.” The rule does 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.”

In accordance with section 361(e) of the PHSA [42 U.S.C. 264(e)], nothing in this rule would supersede any provisions of State or local law except to the extent that such a provision conflicts with this rule.

Under the Plain Language Act of 2010 (P.L. 111-274, October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS/CDC has attempted to use plain language in promulgating this rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble, we propose to amend 42 CFR part 73 as follows:

The additions and revisions read as follows:

The revision and additions read as follows:

The revisions and addition read as follows:

The revision and addition read as follows:

The additions read as follows:

The revision and addition read as follows:

The additions read as follows:

The revision and additions read as follows:

This is a summary of the Commission's Further Notice of Proposed Rulemaking, FCC 15-142, adopted October 21, 2015, and released October 23, 2015.

The FNPRM contains proposed information collection requirements subject to the PRA, Public Law 104-13. OMB, the general public, and other Federal agencies are invited to comment on the proposed new and modified information collection requirements contained in this FNPRM.

Comments on the proposed information collection requirements should address: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”

In addition to filing comments with the Secretary, a copy of any Paperwork Reduction Act comments on the information collection requirements contained herein should be submitted to Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554, or via the Internet to [email protected], and to Nicholas A. Fraser, Office of Management and Budget (OMB), via the Internet to [email protected].

To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page http://www.reginfo.gov/public/do/PRAMain, (2) look for the section of the Web page called “Currently Under Review,” (3) click on the downward-pointing arrow in the “Select Agency” box below the “Currently Under Review” heading, (4) select “Federal Communications Commission” from the list of agencies presented in the “Select Agency” box, (5) click the “Submit” button to the right of the “Select Agency” box, (6) when the list of FCC ICRs currently under review appears, look for the Title of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed.

The proposed information collections are as follows:

OMB Control Number: 3060-0075.

Title: Application for Transfer of Control of a Corporate Licensee or Permittee, or Assignment of License or Permit, for an FM or TV Translator Station, or a Low Power Television Station, FCC Form 345.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit entities; Not for profit institutions; Local or Tribal Government.

Number of Respondents and Responses: 1,700 respondents; 2,700 responses.

Estimated Time per Response: 0.084-1.25 hours.

Frequency of Response: Third party disclosure requirement and on occasion reporting requirement.

Total Annual Burden: 2,667 hours.

Total Annual Cost: $3,958,125.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection of information is contained in Sections 154(i) and 310 of the Communications Act of 1934, as amended.

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information.

Privacy Act Impact Assessment: No impact(s).

Needs and Uses: Filing of the FCC Form 345 is required when applying for authority for assignment of license or permit, or for consent to transfer of control of a corporate licensee or permittee for an FM or TV translator station, or low power TV station.

This collection also includes the third party disclosure requirement of 47 CFR 73.3580 (OMB approval was received for Section 73.3580 under OMB Control Number 3060-0031). 47 CFR 73.3580 requires local public notice in a newspaper of general circulation in the community in which the station is located or providing notice over the air of the filing of all applications for assignment of license/permit. This notice must be completed within 30 days of the tendering of the application. A copy of the newspaper notice or a record of the broadcast notice and the application must be placed in the public inspection file.

On June 29, 2009, the Commission adopted a Report and Order, Amendment of Service and Eligibility Rules for FM Broadcast Translator Stations, MB Docket No. 07-172, FCC 09-59, 24 FCC Rcd 9642 (2009), 74 FR 45126,Sept. 1, 2009, 74 FR 46382, Sept. 9, 2009. In the 2009 Report and Order, the Commission adopted changes to the FM translator rules that allowed AM stations to use authorized FM translator stations to rebroadcast the AM signal locally, retransmitting their AM programming as a “fill-in” service. The adopted cross-service translating rules limited FM translators to providing “fill-in” service only, specifically within the AM primary station's authorized service area.

AM radio stations use Form 345 to apply for authority to assign or transfer such fill-in FM translator stations. Consistent with actions taken by the Commission in the 2009 Report and Order, the following changes were made to Form 345: Section III of Form 345 included a new certification concerning compliance with the AM station “fill-in” service requirements. Specifically, in the AM service, applicants certify that the coverage contour (1 mV/m) of the FM translator station is contained within the lesser of: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site.

On October 21, 2015, the Commission adopted a First Report and Order, Further Notice of Proposed Rulemaking, and Notice of Inquiry, in Revitalization of the AM Radio Service, MB Docket No. 13-249, FCC 15-142. In the Further Notice of Proposed Rulemaking component of this rulemaking proceeding (FNPRM), the Commission proposes to make the following rule (and Form) changes to this information collection: Modify Section 74.1201(g) of the rules to provide that the coverage contour (1 mV/m) of an FM translator station rebroadcasting an AM radio station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station, or a 25-mile radius centered at the AM station's transmitter site, but that in no event may the FM translator's 1 mV/m coverage contour extend beyond a 40-mile (64 km) radius centered at the AM station's transmitter site.

Consistent with actions proposed by the Commission in the FNPRM, the following change is made to Form 345: Section III of Form 345 includes a new certification concerning compliance with the new AM station “fill-in” service requirements. Specifically, applicants will now certify that the 1 mV/m coverage contour of the FM translator station is contained within the greater of either: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site, but the FM translator's 1 mV/m contour may not extend beyond a 40-mile radius centered at the AM station's transmitter site. The instructions for Section III—Assignee/Transferee have been revised to assist applicants with completing the modified question.

With this submission, the Commission is currently seeking to obtain OMB approval for the proposed revisions to 47 CFR 74.1201(g) and FCC Form 345 for this information collection. These revisions will not increase the number of respondents, number of responses, annual burden hours and annual cost for this collection.

OMB Control Number: 3060-0405.

Title: Application for Authority to Construct or Make Changes in an FM Translator or FM Booster Station, FCC Form 349.

Form Number: FCC Form 349.

Type of Review: Revision of a currently approved collection.

Respondents: Business or other for-profit; State, Local or Tribal Government; Not-for-profit institutions.

Number of Respondents and Responses: 1,200 respondents; 2,400 responses.

Estimated Time per Response: 1-1.5 hours.

Frequency of Response: On occasion reporting requirement; Third party disclosure requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in Sections 154(i), 303 and 308 of the Communications Act of 1934, as amended.

Total Annual Burden: 4,500 hours.

Total Annual Cost: $4,674,600.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this information collection.

Needs and Uses: FCC Form 349 is used to apply for authority to construct a new FM translator or FM booster broadcast station, or to make changes in the existing facilities of such stations.

Form 349 also contains a third party disclosure requirement, pursuant to 47 CFR 73.3580. This rule requires stations applying for a new broadcast station, or to make major changes to an existing station, to give local public notice of this filing in a newspaper of general circulation in the community in which the station is located. This local public notice must be completed within 30 days of the tendering of the application. This notice must be published at least twice a week for two consecutive weeks in a three-week period. In addition, a copy of this notice must be placed in the station's public inspection file along with the application, pursuant to 47 CFR 73.3527. This recordkeeping information collection requirement is contained in OMB Control No. 3060-0214, which covers Section 73.3527.

On June 29, 2009, the Commission adopted a Report and Order, Amendment of Service and Eligibility Rules for FM Broadcast Translator Stations, MB Docket No. 07-172, FCC 09-59, 24 FCC Rcd 9642 (2009), 74 FR 45126, Sept. 1, 2009, 74 FR 46382, Sept. 9, 2009. In the 2009 Report and Order, the Commission adopted changes to the FM translator rules that allowed AM stations to use authorized FM translator stations to rebroadcast the AM signal locally, retransmitting their AM programming as a “fill-in” service. The adopted cross-service translating rules limited FM translators to providing “fill-in” service only, specifically within the AM primary station's authorized service area.

AM radio stations use Form 349 to apply for authorizations to operate such fill-in FM translator stations. Consistent with actions taken by the Commission in the 2009 Report and Order, the following changes were made to Form 349: Sections II and III of Form 349 included new certifications concerning compliance with the AM station “fill-in” service requirements. Specifically, in the AM service, applicants certify that the coverage contour (1 mV/m) of the FM translator station is contained within the lesser of: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site.

On October 21, 2015, the Commission adopted a First Report and Order, Further Notice of Proposed Rulemaking, and Notice of Inquiry, in Revitalization of the AM Radio Service, MB Docket No. 13-249, FCC 15-142. In the Further Notice of Proposed Rulemaking component of this rulemaking proceeding (FNPRM), the Commission proposes to make the following rule (and Form) changes to this information collection: Modify 47 CFR 74.1201(g) of the rules to provide that the coverage contour (1 mV/m) of an FM translator station rebroadcasting an AM radio station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station, or a 25-mile radius centered at the AM station's transmitter site, but that in no event may the FM translator's 1 mV/m coverage contour extend beyond a 40-mile (64 km) radius centered at the AM station's transmitter site.

Consistent with actions proposed by the Commission in the FNPRM, the following changes are made to the Form 349: Sections II and III of Form 349 include new certifications concerning compliance with the new AM station “fill-in” service requirements. Specifically, applicants will certify that the 1 mV/m coverage contour of the FM translator station is contained within the greater of either: (a) The 2 mV/m daytime contour of the AM primary station being rebroadcast, or (b) a 25-mile radius centered at the AM station's transmitter site, but the FM translator's 1 mV/m contour may not extend beyond a 40-mile radius centered at the AM station's transmitter site. The instructions for Sections II and III have been revised to assist applicants with completing the modified questions.

With this submission, the Commission is currently seeking to obtain OMB approval for the proposed revisions to 47 CFR 74.1201(g) and FCC Form 349 for this information collection. These revisions will not increase the number of respondents, number of responses, annual burden hours and annual cost for this collection.

1. A number of commenters in this proceeding advocated reducing daytime, nighttime, and critical hours protection afforded to Class A AM stations, which operate with up to 50 kilowatts of power, day and night, and have large extended service areas, especially at night when skywave propagation allows signals to travel hundreds of miles. As a result, during daytime hours, over 200 licensed Class B and Class D AM stations are required to reduce power and/or change to a directional antenna system to meet the required critical hours protection afforded to Class A stations. During nighttime hours—if permitted nighttime operation at all—other stations often must invest in complex directional arrays to protect one of the 73 Class A stations, and/or must substantially reduce their power, sometimes resulting in their having only secondary nighttime facilities. Even for those Class B stations that are protected from interference by other AM stations at night, this often results in sub-standard nighttime coverage, in order to protect the secondary service area of a larger station a considerable distance, and often many states away. Commenters argue that they could provide better service, with more power to overcome the local noise floor, if the protections to Class A stations were relaxed.

2. Class A stations have traditionally provided wide-area service to different regions of the United States, including rural areas, and to travelers driving through their relatively large coverage areas. The high power and large extended service areas of these stations have also proved invaluable in emergencies, such as Hurricane Katrina and its aftermath. Some commenters, however, note that the utility of high-powered, wide-area AM stations has waned since the early days of radio, when the FM service was nonexistent or underutilized, more of the population lived outside of major metropolitan areas, and there were significantly fewer media choices than there are today. Because of this, many commenters believe that the current protection afforded to Class A stations should be reduced, in order to allow other, more local stations to add or increase day and nighttime power to their listening areas. The tradeoff between commenters urging caution in taking any steps that would diminish protection to Class A stations and those arguing that large protected coverage areas for Class A stations are unnecessary appears to be whether the Commission should take steps that would deprive Class A stations of listeners far outside of their primary service areas, if those steps would allow substantial numbers of other stations to improve their service, both day and night, to their communities of license and adjacent areas.

3. While the wide-area service of Class A stations has historically proved to be beneficial, the Commission has seen fit in the past to reduce protection to their skywave service (see, e.g., Clear Channel Broadcasting in the AM Broadcast Band, Report and Order, 78 F.C.C.2d 1345, 1364 (1980), in which the Commission noted that increasing spectrum demands required that protection of such stations (then designated Class I-A stations) beyond the nighttime 0.5 mV/m-50 percent contour, as well as certain restrictions on adjacent-channel stations, be abolished). In this proceeding, the overriding concern is the need for existing AM stations to overcome an increasing noise floor that inhibits local service, both day and night. While reducing protection to a Class A AM station may, in fact, reduce the coverage of that station, the areas of reduced coverage would be located at great distances from the transmitter and from the metropolitan area that constitutes the station's primary service area. At the same time, the reduction in protection may well allow other stations to increase their power to better serve their communities and, in the case of some stations, allow for the first-ever fulltime AM service to those communities. The Commission's goal of localism suggests that service from a local news and information source should be preferred over better reception of a more distant signal.

4. The Commission tentatively concludes, therefore, that (1) all Class A stations should be protected, both day and night, to their 0.1 mV/m groundwave contour, from co-channel stations; (2) all Class A stations should continue to be protected to the 0.5 mV/m groundwave contour, both day and night, from first adjacent channel stations; and (3) the critical hours protection of Class A stations should be eliminated completely. The Commission seeks comment on these proposals, specifically on the populations that would lose service from Class A stations under this proposal and, to the extent ascertainable, whether such populations currently avail themselves of the service that would be lost. The Commission also seeks data on areas and populations in the United States, if any, that receive service only from Class A AM stations, whether day or night. Conversely, it requests specific comment as to the numbers of stations that would be able to increase power, daytime and nighttime, under this proposal and what populations would gain service from those power increases. Additional comment is sought concerning the net effect on listeners that could result from the combination of reduced protection to Class A stations and power increases by co- and adjacent-channel stations that this proposal would allow. Would, in fact, such power increases cause more loss of service to listeners of Class A stations than gains in such service to listeners of upgrading stations? Would current listeners of Class A skywave service, not located near stations able to avail themselves of power increases due to this proposal, nevertheless experience a reduction in skywave service from Class A stations? Would the proposed changes disproportionately affect listeners in rural and/or tribal areas? What effects, if any, would changes in protection to Class A stations have on EAS Primary Entry Point stations during emergencies? Alternatively, should the Commission consider another level of protection to Class A stations, whether greater or less than that proposed and, if so, what should that protection be? The Commission also seeks comment on whether critical hours protection, if not eliminated, should alternatively be modified? Finally, the Commission seeks comment on any costs that are likely to result from adoption of these proposals or from any alternatives proposed by commenters.

5. Several commenters to the NPRM also proposed that the Commission return to the nighttime root-sum-square (RSS) prediction method in existence before the Commission's 1991 rule changes. These prediction methods are used to calculate values of both interfering field strengths from other AM stations and nighttime interference-free (NIF) coverage. Prior to 1991, nighttime RSS values of interfering field strengths and nighttime interference-free coverage were based on calculating the RSS of all interfering signals using the 50 percent exclusion method, considering only co-channel interfering signals. In the 1991 Technical Assignment Criteria order (6 FCC Rcd 6273 (1991)), the Commission changed its method of calculation to include adjacent-channel signals, and to use a tiered system of RSS calculations. Some commenters observed that, despite the Commission's intentions in Technical Assignment Criteria, which were to decrease station-to-station interference in the AM service, in practice the effect was to stifle facility improvements, resulting in very little in the way of decreased interference. They contend, for example, that the 25 percent exclusion method complicates nighttime allocation calculations and protection requirements and reduces flexibility for AM station improvement and relocation; that consideration of adjacent-channel stations in making interference calculations is unnecessary, claiming that the Commission instituted this rule in anticipation of wide-band AM receivers that never made it to market; and that a return to the 50 percent exclusion method used prior to 1991, considering only the skywave contributions to RSS calculations of co-channel stations, would enable AM broadcasters to improve their facilities and signals and, thus, overcome the increasing noise floor.

6. The Commission agreed that the 1991 nighttime skywave interference regulations were well-intentioned but, in retrospect, did not achieve their intended goals and have resulted in unintended adverse consequences, chiefly by impeding facility improvements that are more necessary now than 24 years ago, because the noise floor has increased as much as or more than station-to-station interference, and increasing signal strength to a station's primary service area has become more of a priority than maintenance of rules that offer a small return on interference reduction, compared to the burden they impose on signal improvement. The Commission therefore tentatively concluded that it should roll back the 1991 rule changes as they pertain to calculation of nighttime RSS values of interfering field strengths and NIF service, by amending 47 CFR 78.182(k) to return to predicting the NIF coverage area using only the interference contributions from co-channel stations and the 50 percent exclusion method. The Commission seeks comment on this proposal, and invites in particular comment from parties with differing views, or that have technical evidence demonstrating the effects on inter-station interference of a return to the pre-1991 rules for calculating nighttime skywave interference. In addition, the Commission seeks comment on any costs that commenters believe would result from this proposal.

7. Commenters also proposed changes to 47 CFR 73.37(a), the rule providing daytime protection to AM stations. The rule currently specifies a 26 dB daytime desired to undesired (D/U) protection ratio for co-channel stations, a 6 dB D/U daytime protection ratio for first adjacent channel stations, and a 0 dB daytime D/U protection ratio for second and third adjacent channel stations. Commenters proposed that the Commission return to the pre-1991 0 dB daytime 1:1 protection ratio for first adjacent channels; change second adjacent channel groundwave protection; and eliminate third adjacent channel groundwave protection. Additionally, several commenters suggested changes to the daytime protected contours for Class B, C, and D stations.

8. The Commission tentatively concludes that these rule changes should be adopted. The proposed 0 dB daytime 1:1 first adjacent channel protection ratio was the pre-1991 standard, and the post-1991 protection ratio does not appear to allow for sufficient signal strength to overcome current levels of environmental noise. Likewise, because third adjacent channel interference is relatively insignificant compared to environmental sources of interference, it would seem prudent to eliminate third adjacent channel groundwave protection and change second adjacent channel groundwave protection to match the current levels for third adjacent channel protection, thus allowing AM stations to increase power to overcome increased levels of environmental noise. Changing the daytime primary service contour for Class B, C, and D stations to the 2 mV/m contour harmonizes the protection with the definition of service area that was adopted in the Second Order on Reconsideration in the Rural Radio proceeding (27 FCC Rcd 12829, 12838 (2012)), and would allow AM broadcasters greater flexibility to make station modifications designed to increase signal strength to their primary service areas. The Commission therefore proposes to revise 47 CFR 73.37(a) to reflect the aforementioned changes to daytime protected contours for Class B, C, and D AM stations, and seeks comment on this proposal. Would the proposed reductions in protection result in greater flexibility for AM stations to improve their signals, or would they merely increase inter-station interference? Would the net effect be beneficial or harmful to AM broadcasters and listeners? To the extent possible, commenters should provide technical data in support of their arguments. In addition, commenters should discuss and, if possible, quantify any costs they believe the proposal would entail.

9. Several commenters to the NPRM request that the Commission reconsider the rules for locating cross-service fill-in FM translators. Currently, such translators must be located such that the 60 dBµ contour of any such FM translator station must be contained within the lesser of (a) the 2 millivolts per meter (mV/m) daytime contour of the AM station, or (b) a 25-mile radius centered at the AM transmitter site. Commenters argue that the current rule is too restrictive. Some commenters maintain that the 25-mile limitation is arbitrary, or that it unfairly penalizes stations located far from cities due to land costs or those that have deep nulls in their directional patterns. Others advocate eliminating the 25-mile restriction and would have us allow the translator to be sited anywhere within the 2 mV/m contour, and others suggest even more flexibility.

10. When the Commission adopted the current limits on siting of cross-service translators re-broadcasting AM stations, it re-affirmed that FM translators re-broadcasting AM stations were intended to fill service voids rather than to expand service, and that the adopted limits were to “ensure that fill-in cross-service translators are used in the AM station's core market area, rather than in a fringe area that may be part of or near another radio market.” Amendment of Service and Eligibility Rules for FM Broadcast Translator Stations, Report and Order, 24 FCC Rcd 9642, 9658-59 (2009). In the FNPRM, however, the Commission agreed that some additional degree of flexibility is appropriate, especially given the factual situations (e.g., highly directional antenna patterns with deep signal nulls) described by some commenters. The Commission also wished to continue to limit cross-service translator use to an AM station's core market. It therefore proposes to modify 47 CFR 74.1201(g) to provide that the coverage contour (1 mV/m) of an FM translator rebroadcasting an AM radio broadcast station as its primary station must be contained within the greater of either the 2 mV/m daytime contour of the AM station or a 25-mile (40 km) radius centered at the AM transmitter site, but that in no event may the translator's 1 mV/m coverage contour extend beyond a 40-mile (64 km) radius centered at the AM transmitter site. The Commission stated that this proposal provides sufficient flexibility to provide useful signal coverage, while not allowing a cross-service fill-in translator to extend the station's coverage beyond its core service area. The Commission invites further comment on this proposal, including comment on any costs that commenters believe are likely to arise from the proposal.

11. Partial proof of performance measurements are required for AM stations using directional antennas whenever the licensee has reason to believe that the radiated fields may be exceeding the limits for which the station is authorized, and whenever minor directional antenna system repairs are made that result in certain changes to the station's licensed operating parameters. Some commenters request that 47 CFR 73.154, the current rule governing partial proof of performance field strength measurements for AM directional antenna arrays, be modified to require measurements only on radials containing a monitoring point. Currently, the rule requires field strength measurements on all radials with a monitoring point, as well as on radials from the latest complete field strength proof of performance that are adjacent to the monitored radials, if the array has fewer than four monitored radials. Proponents claim that eliminating the requirement to take measurements on non-monitored radials will reduce the cost to maintain AM directional antenna systems in working order. The Commission agreed that the proposed reduction in measured radials would result in a cost savings for directional antenna system maintenance for AM broadcasters, and would not result in more AM directional antenna systems being out of adjustment. It therefore tentatively concludes, and proposes, that 47 CFR 73.154(a) be modified accordingly. The Commission seeks comment on this proposal, including comment on whether and to what extent the proposed rule modification would reduce costs to AM broadcasters employing directional antenna systems.

12. In 2008, the Commission adopted rules permitting use of Method of Moments (MoM) computer modeling to verify the performance of AM station directional antenna systems. Since then, over 220 MoM directional antenna proofs of performance have been prepared by AM station licensees and their engineers and submitted to the Commission in support of AM station applications for license. Based on their experience gained in the seven years since the adoption of the MoM proof rules, several technical commenters propose the following changes to the AM MoM proof rules: (1) eliminate or modify the recertification measurements requirements and removal of base sampling devices for periodic testing in 47 CFR 73.155; (2) eliminate the requirement for reference field strength measurements (47 CFR 73.151(c)(3)); (3) eliminate the requirement for surveying existing directional antenna arrays as long as tower geometry is not being modified and no new towers are being added to the array; (4) clarify that 47 CFR 73.151(c)(1)(viii) applies only when total capacitance used to model base region effects exceeds 250 pF and modify same to apply only when base current sampling is used; (5) Permit use of MoM modeling for skirt-fed towers; (6) Change MoM rules with regard to re-proofing when antennas are added to towers; and (7) Eliminate requirement for current distribution measurements for top-loaded or other unusual antenna configurations when MoM or other numerical analysis method is used to determine antenna characteristics.

13. Based on the Commission's experience with MoM proofs over the past seven years, it believed that, except as noted below, the changes listed above are well-founded, would improve the quality of the MoM proofs submitted to the Commission, would not result in inferior adjustments of AM directional antenna arrays, and would eliminate some unnecessary expenses for directional antenna array maintenance by AM station licensees. It therefore tentatively concludes that the above-listed procedural and rule changes, with the exception of the elimination of reference field strength measurements, should be adopted, and invites comment on these changes, particularly from AM broadcasters operating with directional antenna arrays. Rather than eliminate reference field strength measurements, which provide the only external verification that a directional antenna array is operating properly, the Commission tentatively concludes and proposes that 47 CFR 73.151(c)(3) be modified to require reference field strength measurements when the initial license application is submitted for a directional antenna system based on computer modeling and sample system verification. Subsequent licenses for the same directional antenna system and physical facilities will not require submission of new reference field strength measurements. The Commission seeks comment on whether, instead of eliminating recertification measurements, it should modify the rules to require them within a specific time period near, but prior to, the submission of the station's license renewal application, or at some other time interval. What constraints should the Commission impose on the physical model of a skirt-fed antenna element in the MoM computer program? Due to the complexity of modeling a skirt-fed tower, should it require use of specific MoM software to model them? What requirements should it specify for sampling systems for skirt-fed antenna elements? What costs, if any, are likely to arise as a result of any of the foregoing proposals?

14. In 1991, the Commission adopted rules and procedures for initial licensing of stations in the 1605-1705 kHz AM band (Expanded Band). In opening up the Expanded Band, the Commission's intent was to selectively open the ten Expanded Band frequencies to those existing AM stations that most significantly contributed to congestion and interference in the standard AM band, removing interference from the standard band and providing those stations with more robust, interference-free service in the Expanded Band. To ease the financial uncertainty of migrating to the then-new and untested Expanded Band, the Commission established a five-year transition period, during which migrating stations would hold licenses in both the Expanded Band and standard AM band, and could simulcast programming over both. This five-year period was set forth in a condition to each Expanded Band license, and began to run as of the date of initial licensing in the Expanded Band. After the five-year transition period, each dual-station licensee would be required to surrender either its standard band or its Expanded Band license. The Commission has never abandoned the requirement that the dual standard/Expanded band stations relinquish one of their authorizations, and many such stations have done so. The 25 remaining such station pairs, listed in Appendix F to the FNPRM, negate the Commission's goal to reduce interference in the standard AM band, and their retention of both authorizations disserves the other licensees who complied with the relinquishment requirement. A number of the stations still holding dual standard band/Expanded Band authorizations have filed requests for waiver of the surrender condition and prohibition against sale of one of the authorizations.

15. Given the Commission's consideration, in a Notice of Inquiry that follows the FNPRM, of further utilization of the Expanded Band, along with its general concern for revitalization of the AM service, there is no justification for allowing licensee retention of high-interfering standard band stations along with the Expanded Band stations meant to replace them. The Commission therefore tentatively concludes that any licensee with dual standard/Expanded Band authorizations should be required to surrender one of the two authorizations within one year of release of a future Report and Order in this proceeding adopting this proposal. The Commission tentatively concludes that the required election should be made by the station licensee in writing, by letter delivered to the Office of the Secretary, with copy to the Media Bureau, Audio Division, not later than twelve months following release of a future Report and Order adopting this proposal, or such other date as is established in the Report and Order and/or in any notice delivered to the licensee by the Media Bureau. The Commission further tentatively concludes that, should a station not make the election regarding which of the two authorizations it wishes to retain within the required time period, its standard band authorization should be canceled, and the station required to operate only as authorized in the Expanded Band. The Commission seeks comment on these proposals, including any comments in favor of licensee retention of dual authorizations, comments on whether it should adopt a shorter or longer deadline for the required election, comments regarding the effect of such retention of dual authorizations on the AM service generally and the Expanded Band specifically, and comments on any costs associated with surrender of these authorizations.

16. Utilization of AM Expanded Band. In Review of the Technical Assignment Criteria for the AM Broadcast Service, Report and Order, 6 FCC Rcd 6273, 6302-23 (1991), 56 FR 64842 (Dec. 12, 1991) (Technical Assignment Criteria), the Commission established rules and policies for stations initially licensed in the Expanded AM Band (1605-1705 kHz) (Expanded Band), including technical rules. See generally Technical Assignment Criteria, 6 FCC Rcd at 6311-14, 6321-23. For example, it decided to administer channels in the Expanded Band on an allotment basis based on fixed technical parameters, similar to allotments in the FM broadcast band, rather than on an assignment basis as in the standard AM band, in which the technical facilities of each station are uniquely designed to avoid interference to other stations on the band. 47 CFR 73.30. A total of 88 Expanded Band channels were originally allotted, and licenses were granted to 54 stations that migrated from the standard AM band to the Expanded Band. The Commission proposed, in the Further Notice of Proposed Rule Making (FNPRM) in this proceeding, to require the remaining 25 dual standard-Expanded Band station pairs to surrender one authorization each. Now that it has had experience with actual, operating Expanded Band AM stations, the Commission inquires whether to open up the Expanded Band to additional stations, and under what conditions.

17. Several commenters remark that the Expanded Band is underutilized and should be opened up to more stations. Some prefer, as before, that the Expanded Band be used for stations migrating from the standard band; others believe that preference should first be given to applicants for new AM stations, licensed daytime-only AM stations, or licensed or new AM stations proposing all-digital operation. Most who address the Expanded Band state that stations in that band should be assigned in the same way they are assigned in the standard AM band, rather than continuing the allotment procedures currently used in the Expanded Band. Commenters also urge that a station migrating from the standard band to the Expanded Band relinquish its standard band license shortly after initiating Expanded Band service. Although many commenters address the use of the Expanded Band in helping to revitalize the AM service, there are a number of procedural and practical decisions to be made before proposing rules for further utilization of that band. The Commission believes that a more complete record is needed before proposing rules regarding further expansion of the 1605-1705 kHz band.

18. As a threshold matter, the Commission asks commenters whether they believe that opening the Expanded Band to further development would be beneficial to revitalization of the AM service. Assuming agreement with that premise, who should be allowed to receive authorizations in the Expanded Band? Should preference be given to new stations, to migrators from the standard band, to stations planning all-digital operation, or should some other criterion be established? If the Expanded Band were opened to new stations, an auction filing window would need to be opened, and mutually exclusive applications would be subject to all competitive bidding procedures, including threshold Section 307(b) comparisons and possible auctions. Additionally, if the Expanded Band were opened to major modifications, any mutually exclusive groups including major modification applications would have the opportunity for settlements or technical resolutions. 47 CFR 73.5002(d)(1), (2). If the Commission were to reserve the Expanded Band for migrators from the standard AM band, should it open a window, waive the major change rule, and allow migrators to apply as minor modifications on a first-come, first-served basis, or use some other mechanism (as, for example, the initial assignment of stations to the Expanded Band by prioritizing major interferers)? With regard to migrating stations, the Commission tentatively agrees with those commenters who have suggested that, in the event such migration is allowed, a “flash cut” from the standard band authorization to the Expanded Band operation should take place, that is, the standard band authorization would be relinquished upon commencing Expanded Band transmissions. The Commission seeks other views on this matter, however.

19. With regard to Expanded Band technical facilities, currently stations in the Expanded Band are allotted on a minimum distance separation standard similar to FM stations, rather than the contour-protection procedures used for standard band AM stations. As noted in Technical Assignment Criteria, assigning channels based on contour protection maximizes the number of stations on each channel, whereas allotting stations based on spacing was believed to promote a higher-quality technical service in the Expanded Band. 6 FCC Rcd at 6311-12. Commenters favoring opening up the Expanded Band overwhelmingly prefer instituting contour protection standards. The Commission seeks comment on the relative merits of each method of channel assignment or allotment. Additionally, to the extent commenters favor contour protection, they should also address whether compliance with contour protection standards should be limited to use of M3 ground conductivity for contour prediction, or should the Commission allow use of measured ground conductivities in predicting contours?

20. The Commission also seeks comment on whether to allow other classes and powers of stations (except for Class D stations, which are no longer authorized), to the extent permitted by our international agreements, or whether it should authorize the same power (e.g., 10 kW day/1 kW night) for all new Expanded Band stations. A related question would be whether to allow complex directional patterns in the Expanded Band or limit applications to non-directional and simple directional (i.e., no more than three-tower array) stations. If commenters were to favor limiting the Expanded Band to all-digital stations, the Commission would seek comment as to the contour protections and allocation standards for all-digital operation. At the moment, testing is continuing with regard to all-digital (as opposed to hybrid digital) AM operations, and the record is not yet established on the technical standards needed to establish interference protection for digital-to-digital stations, much less digital-to-analog or digital-to-hybrid. The absence of a technical record leads the Commission to believe that it may be premature to discuss limiting the Expanded Band to all-digital operation; however it welcomes comments that include technical data that would further inform it on this issue.

21. Relaxed Main Studio Requirements. 47 CFR 73.1125(a) provides, in pertinent part, that “each AM, FM, and TV broadcast station shall maintain a main studio” at a location complying with paragraphs (a)(1)-(a)(3) of that section.1 Moreover, the Commission has long held that a station must, at a minimum, maintain full-time managerial and full-time staff personnel at its main studio. Jones Eastern of the Outer Banks, Inc., Memorandum Opinion and Order, 6 FCC Rcd 3615, 3616 (1991). Commenters Blount Masscom, Inc., et al. (Blount), note that the Commission often grants waivers of the main studio requirement to noncommercial educational (NCE) stations, allowing them to co-locate a station's main studio at the studio of another station licensed to the same licensee that may be outside the locations allowed by 47 CFR 73.1125(a), and that the rule language contemplates such waivers for commercial stations, although such waivers are seldom if ever granted. Blount proposes that AM station owners be allowed to request such waivers, or at a minimum that certain classes of AM stations, notably Class D stations, be allowed to do so. Blount further proposes that AM stations without co-owned main studios available should be allowed to adopt relaxed staffing requirements, such as requiring staffing only during part of the day or week, or allowing the use of technology to permit members of the public to contact station personnel who are not physically present at the main studio. Three other commenters support Blount's proposals.

22. The Commission has historically considered a station's main studio to constitute the location from which the station can adequately meet its function of serving the needs and interests of the residents of the station's community of license. This includes being adequately equipped to transmit programming, having a meaningful management and staff presence, and serving as a location for the station's public file. The Commission continues to emphasize a station's function of meeting the needs and interests of its community. At the same time, however, it is aware of the financial strain on many AM broadcasters. Moreover, advances in technology (e.g., email, mobile telephone, Internet) can enable members of the community to contact station personnel without having to physically visit the main studio. In fact, the Commission has recently proposed requiring AM and FM broadcast stations to post their public files to the Commission's online database, which would make them accessible without the need for visiting a station's offices or main studio. Expansion of Online Public File Obligations, Notice of Proposed Rule Making, 29 FCC Rcd 15943 (2014).

23. Despite these advances in accessibility to broadcast stations and their personnel, the Commission is reluctant to eliminate main studio requirements entirely, because of the aforementioned importance of the main studio to the goal of ensuring station compliance with local service obligations. The Commission therefore seeks comment on whether, and how, to modify the main studio rule in light of its goal in this proceeding to revitalize the AM service. Should it continue to address waivers of the main studio rule on a case-by-case basis, but be more open to such requests by commercial stations that can co-locate in studio facilities used by co-owned stations in a given market? Assuming that the Commission were to allow relaxation of the requirement that each station maintain a separate main studio, is there a maximum number of co-located stations that it should allow under one roof? If it were to allow co-location of two or more stations, should it further relax the requirements by allowing one or more of the stations to be located outside of the area dictated by 47 CFR 73.1125(a)(1) through (a)(3)? If one or more co-located stations are allowed to locate outside the rule requirements, should there be an absolute restriction on the distance a co-locating station may move its studio from its community of license? Moreover, should the Commission, as Blount suggests, relax the staffing requirement of full-time management and staff presence for AM stations that do not have co-owned stations with which to co-locate studio facilities? Should any such relaxation of staffing requirements necessarily be limited to such “stand alone” AM stations? If the Commission were to relax staffing requirements, what if any conditions should be put in place to ensure that members of the public could contact station personnel and receive timely responses? Should it require that local mobile phone numbers for station management and staff be posted or otherwise publicized? Should any relaxation of main studio or staffing rules be linked to a station's posting of its public file to the Commission online database? The Commission seeks comment addressing these and any other matters pertaining to AM stations' maintenance of fully staffed local main studios. In particular, the Commission invites comment on the cost reductions that may result from modification of the main studio rule.

24. Pursuant to §§ 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 the Commission's Electronic Comment Filing System (ECFS). See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).

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

• Commercial Mail sent by 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 should be addressed to 445 12th Street SW., Washington, DC 20554.

25. This is a summary of the Commission's document FCC 15-142, Revitalization of the AM Radio Service, Further Notice of Proposed Rulemaking (FNPRM) and Notice of Inquiry (NOI), adopted on October 21, 2015 and released on October 23, 2015, in MB Docket No. 13-249. The full text of document FCC 15-142 will be available for public inspection and copying via ECFS, and during regular business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. Document FCC 15-142 can also be downloaded in Word or Portable Document Format (PDF) at http://www.fcc.gov/ndbedp.

26. This proceeding shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 et seq. Persons making ex parte presentations must file a copy of any written presentation or a memorandum summarizing any oral presentation within two business days after the presentation (unless a different deadline applicable to the Sunshine period applies). Persons making oral ex parte presentations are reminded that memoranda summarizing the presentation must (1) list all persons attending or otherwise participating in the meeting at which the ex parte presentation was made, and (2) summarize all data presented and arguments made during the presentation. If the presentation consisted in whole or in part of the presentation of data or arguments already reflected in the presenter's written comments, memoranda or other filings in the proceeding, the presenter may provide citations to such data or arguments in his or her prior comments, memoranda, or other filings (specifying the relevant page and/or paragraph numbers where such data or arguments can be found) in lieu of summarizing them in the memorandum. Documents shown or given to Commission staff during ex parte meetings are deemed to be written ex parte presentations and must be filed consistent with 47 CFR 1.1206(b). In proceedings governed by 47 CFR 1.49(f) or for which the Commission has made available a method of electronic filing, written ex parte presentations and memoranda summarizing oral ex parte presentations, and all attachments thereto, must be filed through the electronic comment filing system available for that proceeding, and must be filed in their native format (e.g., .doc, .xml, .ppt, searchable .pdf). Participants in this proceeding should familiarize themselves with the Commission's ex parte rules.

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

28. As required by the RFA (5 U.S.C. 603), Commission has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the FNPRM. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments on the FNPRM provided in paragraph 94 of the FNPRM. The Commission will send a copy of this entire FNPRM, including this IRFA, to the Chief Counsel for Advocacy of the Small Business Administration (SBA). In addition, the FNPRM and the IRFA (or summaries thereof) will be published in the Federal Register.

29. This rulemaking proceeding is initiated to obtain further comments concerning certain proposals designed to revitalize the AM broadcast radio service. It is based in substantial part on proposals raised by commenters in this rulemaking proceeding, in response to the Commission's call in the original NPRM in this proceeding for further ideas and proposals.

30. Specifically, the Commission seeks comment on the following: (1) Whether to change the nighttime and critical hours signal protection to Class A AM stations; (2) whether to change the methodology for calculating nighttime root sum square (RSS) values; (3) whether to change daytime signal protection to Class B, C, and D stations; (4) whether to revise the rule on where an FM cross-service translator station, re-broadcasting an AM station's signal, may be located relative to the AM station's transmitter; (5) whether to modify the rules governing partial proofs of performance of directional AM antenna arrays; (6) whether to modify the rules for method of moments proofs for directional AM antenna arrays; and (7) whether to require licensees holding dual standard band-Expanded Band AM licenses to surrender one of the licenses within one year of release of the Second Report and Order in this proceeding.

31. The authority for this proposed rulemaking is contained in Sections 1, 2, 4(i), 303, 307, and 309(j) of the Communications Act of 1934, 47 U.S.C. 151, 152, 154(i), 303, 307, and 309(j).

32. The RFA directs the Commission to provide a description of and, where feasible, an estimate of the number of small entities that will be affected by the proposed rules. The RFA generally defines the term “small entity” as encompassing the terms “small business,” “small organization,” and “small governmental entity.” In addition, the term “small Business” has the same meaning as the term “small business concern” under the Small Business Act. A small business concern is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.

33. The proposed rules and policies could apply to AM radio broadcast licensees, and potential licensees of the AM radio service. A radio broadcasting station is an establishment primarily engaged in broadcasting aural programs by radio to the public. Included in this industry are commercial, religious, educational, and other radio stations. Radio broadcasting stations which primarily are engaged in radio broadcasting and which produce radio program materials are similarly included. However, radio stations that are separate establishments and are primarily engaged in producing radio program material are classified under another NAICS number. The SBA has established a small business size standard for this category, which is: Firms having $38.5 million or less in annual receipts. 13 CFR 121.201, NAICS code 515112 (updated for inflation in 2008). According to the BIA/Kelsey, MEDIA Access Pro Database on October 15, 2015, 4,691 (99.94%) of 4,694 a.m. radio stations have revenues of $38.5 million or less. Therefore, the majority of such entities are small entities. The Commission noted, however, that, in assessing whether a business concern qualifies as small under the above definition, business (control) affiliations must be included. See 13 CFR 121.103(a)(1). This estimate, therefore, likely overstates the number of small entities that might be affected by our action, because the revenue figure on which it is based does not include or aggregate revenues from affiliated companies. In addition, an element of the definition of “small business” is that the entity not be dominant in its field of operation. The Commission is unable at this time to define or quantify the criteria that would establish whether a specific radio station is dominant in its field of operation. Accordingly, the estimate of small businesses to which rules may apply do not exclude any radio station from the definition of a small business on this basis and therefore may be over-inclusive to that extent. Also as noted, an additional element of the definition of “small business” is that the entity must be independently owned and operated. It is difficult at times to assess these criteria in the context of media entities and Commission estimates of small businesses to which they apply may be over-inclusive to this extent.

34. The proposed policies could affect licensees of FM translator stations, as well as potential licensees in this radio service. The same SBA definition that applies to radio broadcast licensees would apply to these stations. The SBA defines a radio broadcast station as a small business if such station has no more than $38.5 million in annual receipts. See 13 CFR 121.201, NAICS code 515112. Currently, there are approximately 6,422 licensed FM translator and booster stations. In addition, there are approximately 225 applicants with pending applications filed in the 2003 translator filing window. Given the nature of these services, it is presumed that all of these licensees and applicants qualify as small entities under the SBA definition.

35. The proposed rule and procedural changes may, in some cases, impose different reporting, recordkeeping, or other requirements on existing and potential AM radio licensees and permittees. In the case of proposed changes to the technical rules regarding calculation of daytime and nighttime interfering contours, and changes to daytime, nighttime, and critical hours protection to some stations, there would be changes in the calculation of inter-station interference and reporting of same. However, the information to be filed is already familiar to broadcasters, and the nature of the interference calculations would not change, only the values that are acceptable, so any additional burdens would be minimal. Likewise, the proposed revision to the rules on where an FM translator providing fill-in service for an AM station may be sited will not require any additional calculations on the part of the AM station proposing to locate or relocate the translator. The proposal merely relaxes the siting requirement and expands the area in which such a cross-service fill-in translator may be located. Thus, there should be no additional reporting or recordkeeping burdens, and compliance with the siting rules will be easier. The proposed modifications to the partial proof of performance and Method of Moments rules would not change any reporting or compliance requirements, insofar as AM licensees and applicants would not be required to submit such proofs or models more frequently than is now the case. The only changes would be to relax the requirements for making proofs of performance or method of moments models. Thus, the required submissions of such proofs and models would be less burdensome on AM broadcasters with directional antenna arrays that are required to submit such information. Finally, the proposal to require surrender of licenses held by broadcasters with paired standard band-Expanded Band AM stations will not change any reporting, recordkeeping, or other compliance requirements, and will in fact reduce such requirements for such licensees by 50 percent.

36. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities. 5 U.S.C. 603(b). In the FNPRM, the Commission seeks to assist AM broadcasters by changing certain daytime, nighttime, and critical hours interference protection standards as they apply to certain classes of AM stations; proposes relaxing the rules on siting of FM translators providing fill-in service for AM broadcast stations; proposes to modify the measurement requirements for AM directional antenna system partial proofs of performance in order to make them less burdensome; and proposes to modify the rules for submitting method of moments models of proposed AM directional antenna systems, in order to make those rules less burdensome. The Commission also seeks either to reduce interference in the standard AM band or, alternatively, to create more spectrum in the Expanded AM Band, by requiring that the 25 remaining licensees holding paired authorizations in both bands surrender one of the paired licenses. Under the Commission's proposal, such a licensee would be given one year from adoption of this proposal in which to elect which authorization it would surrender. The Commission seeks comment as to whether its goal of revitalizing the AM service could be effectively accomplished through these means. The Commission is open to consideration of alternatives to the proposals under consideration, as set forth herein, including but not limited to alternatives that will minimize the burden on AM broadcasters, most of which are small businesses. There may be unique circumstances these entities may face, and the Commission will consider appropriate action for small broadcasters when preparing a Second Report and Order in this matter.

37. None.

38. To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (TTY).

39. Accordingly, it is ordered that, pursuant to sections 4(i), 301, 303(r), 316, and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 303(r), 316, 403, this Further Notice of Proposed Rulemaking is adopted.

40. It is further ordered that, pursuant to Sections 1, 303(g), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 303(g), and 403, and Section 1.430 of the Commission's rules, 47 CFR 1.430, that this Notice of Inquiry is adopted.

For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 73 and 74 as follows:

Motherships and Catcher/Processors

An at-sea scale program was developed for the Alaska groundfish fishery in 1998 to provide catch accounting that was more precise and verifiable at the individual haul level and less dependent on estimates generated by at-sea observers (February 4, 1998; 63 FR 5836). The at-sea scale program supported implementation of a large-scale quota share program that required verifiable and defensible estimates of harvest. Since implemenation of those weighing requirements in 1998, at-sea scales have been used to provide reliable, precise and accurate estimates of catch in the Alaskan groundfish fisheries. At the same time, scale technology has evolved and NMFS has developed greater expertise in monitoring processing activity.

Recent fraud on some vessels was found to have resulted in systematic underestimates of scale weights used for catch accounting. As a result, at-sea flow scale regulations for the Alaska Region at 50 CFR 679.28 were revised on December 18, 2014 (November 18, 2014; 79 FR 68610) to improve scale accuracy and reduce bias. Revisions to the Alaska regulations included a suite of modifications to the at-sea scales program that included the use of flow scales capable of logging and printing the frequency and magnitude of scale calibrations relative to previous calibrations as well as the time and date of each scale fault (or error) and scale startup time; revised daily scale test methods; and new requirements for video monitoring.

In 2011, a trawl rationalization program was implemented for the Pacific Coast groundfish fishery which included scale requirements specified in regulation at § 660.15(b) (December 15, 2010; 75 FR 78344). These regulations require mothership and catcher/processor vessels to use scales certified for the Alaska groundfish fisheries. Modifying the Pacific Coast groundfish fishery regulations to be consistent with the Alaska Region's 2014 regulation updates would bring the regulations up to date with current technology, reduce the potential for scale tampering, and improve catch accounting accuracy. Catch estimates based on inaccurate scale weights could systematically underestimate harvests. Given the importance of using accurate and reliable catch accounting data for management of the groundfish stocks, NMFS is proposing revisions consistent with the revisions made for the Alaska groundfish fishery and with the intent of enforcement and monitoring provisions implemented under Amendment 20 to the Pacific Coast groundfish fishery management plan (FMP).

This proposed rule would update the requirements for scales consistent with the Alaska regulations at § 679.28. Improved scale technology includes features that allow NMFS to determine how well the flow scales are performing, and improve the accuracy and reliability of flow scale measurements. Because the mothership and catcher/processor vessels already have upgraded scale systems for the Alaska Fisheries, and the scales are certified through annual testing provided by the Alaska Region, aligning the performance and technical requirements is reasonable and not expected to result in added costs to the vessels.

Regulatory revisions would include improvements to daily scale tests. The types of material used for the daily scale test would be limited to test materials (i.e., pre-weighed sand bags) supplied by the scale manufacturer or approved by a NMFS-authorized scale inspector. The minimum amount of weight for each test and the number of runs would be clearly stated in regulations. In addition, new requirements for documenting failed scale tests, and printing audit and calibration reports would be specified.

Regulatory revisions would require that all mothership and catcher/processors vessels use video monitoring systems that meet the Alaska fishery system requirements, specified at § 679.28(e), when they are fishing in the Pacific Coast groundfish fishery. The video monitoring systems allow the activities around the flow scale to be monitored to ensure that the flow scale is functioning properly (e.g., that the flow scale is not running while in a fault (error) state); ensure that all fish are being weighed; detect when crew members are working on the flow scale; and ensure that daily flow scale tests are being conducted on the required schedule and with the appropriate test weights. The video systems would be required to capture imagery of areas where the catch enters, moves across and leaves the scale; of any access points that may be adjusted or modified by crew; and of the scale display and the indicator of when the scale is operating in a fault state. Consistent with the Alaska requirements, the vessel operator would be required to maintain the video imagery for at least 120 days and make the imagery available to NMFS upon request. All of the vessels subject to at-sea scales requirements are already required to have video systems for the Alaska fisheries. Therefore, the increased burden to the processing vessels would primarily be the time to operate the systems while fishing in the Pacific whiting fishery.

Regulations at § 660.15(c) define the performance and technical requirements for scales used to weigh fish at Shorebased IFQ first receivers. Since the Shorebased IFQ program was implemented in 2011, some Shorebased IFQ first recievers located in Oregon and Washington have installed flow scales. The states of Oregon and Washington test the flow scales consistent with national weights and measures standards. This action would revise regulations to include performance and technical requirements for flow scales used at IFQ first receivers. In addition, several minor technical changes would be made. The regulatory changes for first receivers would include revisions to inseason scale test requirements specific to flow scales; adding catch monitors to the list of individuals that have access to scale displays and printouts; revisions to inseason scale test requirements specific to flow scales; and the correction of a value for maximum error in scale divisions.

Numerous minor changes would be made throughout the regulations at 50 CFR 660.15, 660.113, 660.150 and 660.160 for clarity, to better align different sections of the regulations, to update cross references, and for consistency in the use of terms. Paragraph 660.15(a) is revised to remove reporting requirements that are repeated in other more appropriate sections of the regulations. Regulatory language originally adopted from the Alaska Groundfish fisheries is not consistent with language used for the Pacific Coast groundfish fishery; therefore, minor revisions are made to paragraph § 660.15(b) for clarity and to be consistent with other sections of the Pacific Coast groundfish regulations. Minor changes are made at § 660.15(c) to revise terms for consistent use throughout the regulations. Minor changes are made at § 660.113 to revise terms for consistent use throughout the regulations and update cross references. Minor changes are made §§ 660.150(b) and 660.160(b) to revise terms for consistent use throughout the regulations, and update cross references, to add missing references for cease fishing reports and to add clarity to the vessel responsibilities relative to observer platform scale.

NMFS has made a preliminary determination that the proposed action is consistent with FMP, the Magnuson Stevens Conservation and Management Act, and other applicable laws. In making its final determination, NMFS will take into account the complete record, including the data, views, and comments received during the comment period.

The Office of Management and Budget has determined that this proposed rule is not significant for purposes of Executive Order 12866.

The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration (SBA) that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities.

The SBA has established size criteria for all major industry sectors in the United States, including fish harvesting and fish processing businesses. A business involved in fish harvesting is a small business if it is independently owned and operated and not dominant in its field of operation (including its affiliates) and if it has combined annual receipts not in excess of $20.5 million for all its affiliated operations worldwide. For commercial shellfish harvesters, the other qualifiers apply and the receipts threshold is $5.5 million. For other marine fishing, a small business is one with annual receipts not in excess of $7.5 million. For purposes of rulemaking, NMFS is applying the $20.5 million standard to catcher/processors because they are involved in the commercial harvest of finfish. A seafood processor is a small business if it is independently owned and operated, not dominant in its field of operation, and employs 500 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide. A wholesale business servicing the fishing industry is a small business if it employs 100 or fewer persons on a full time, part time, temporary, or other basis, at all its affiliated operations worldwide.

The mothership and catcher/processor vessels affected by the proposed action have gross revenues that exceed $20.5 million and thus are not considered to be small entities.

IFQ first receivers receive, purchase, or take custody, control, or possession of fish onshore directly from IFQ vessels. In 2012, a total of 26 companies accepted IFQ fish as first receivers: nine accepted Pacific whiting, 25 accepted fish from the IFQ non-whiting trawl, and 19 accepted fish from the non-trawl IFQ. Sixteen of the 26 IFQ first receivers are independently owned and operated, not dominant in their field of operation, and employ 500 or fewer persons on a full time, part time, temporary, or other basis, at all affiliated operations worldwide, and are considered small businesses under the SBA guidelines. First receiver earnings are comprised of fish sales, offloading revenue, custom processing revenue, and revenue from leasing or selling quota.

Although the inclusion of inseason flow scale testing criteria affects all first receivers, it is unlikely that smaller non-whiting first receivers will have the need to install flow scales. To date, flow scales have been used by Pacific whiting first receivers to weigh large volumes of unsorted fish. The only groundfish fishery allowed to land large volumes of unsorted fish is the Pacific whiting fishery. Two of the nine first receivers who accept and purchase Pacific whiting would be considered small according to the SBA guidelines. Some of the Pacific whiting first receivers share ownership of vessels and some companies own multiple first receiver facilities. In addition to Pacific whiting, the Pacific whiting first receivers process other Pacific Coast species including: Pink shrimp, non-whiting groundfish, crab, and coastal pelagic species.

Current regulations require IFQ first receivers to use scales that are tested for accuracy and approved for use by the state where the scale is located. During the fishing season NMFS staff, NMFS-authorized personnel, and authorized officers conduct accuracy tests on scales used to weigh IFQ fish. Inseason test criteria are needed to determine if the scales are functioning accurately between state testings. A scale that does not pass an inseason test may not be used to weigh IFQ catch fish until the scale passes an inseason test or is approved for continued use by the weights and measures authorities of the State in which the scale is located. Since the start of the Shorebased IFQ Program in 2011, three of the nine Pacific Whiting IFQ first receivers have installed flow scales. Two of the three Pacific whiting IFQ first receivers that have installed flow scales are considered small businesses.

The testing criteria defined by this action for flow scales are consistent with the National Institute of Standards and Technology and the criteria used by the states. Because state laws already require commercial scales to meet accuracy standards set out by the National Institute of Standards and Technology, the cost of inseason testing to ensuring compliance between state testings is expected to be minimal. The proposed action is not expected to result in a significant economic effect on a substantial number of small entities. Establishing inseason scale test criteria for this new type of scale would result in inseason scale test requirements that are more equitable between all first receivers. The proposed action is primarily administrative in bringing the regulations up to date with current practices. An initial regulatory flexibility analysis is not required and none has been prepared because this proposed rule would not have a significant economic impact on a substantial number of small entities.

This proposed rule contains a collection-of-information requirement subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been submitted to OMB for approval as revisions to OMB collection 0648-0619. The public reporting burden for the at-sea scale requirements, including daily test reports (30 minute per response), daily catch and cumulative weight reports (10 min per response), the audit trail (1 minute per response), calibration log (1 minute per response), fault log (1 minute per response) and video monitoring (0 minute per response), is estimated to average 43 minutes per response.

Public comment is sought regarding whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to West Coast Region at the ADDRESSES above, and by email to [email protected] or fax to (202) 395-7285.

Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.

For the reasons set out in the preamble, 50 CFR part 660 is proposed to be amended as follows: