        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 152
        [EPA-HQ-OPP-2010-0427; FRL-8850-4]
        RIN 2070-AJ26
        Declaration of Prion as a Pest Under FIFRA and Amendment of EPA's Regulatory Definition of Pests To Include Prion

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          EPA proposes to declare a prion (i.e., proteinaceous infectious particle) a “pest” under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and to amend its regulations to expressly include prion within the regulatory definition of pest. EPA currently considers a prion to be a pest under FIFRA, so a product intended to reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion-related product”) is considered to be a pesticide and regulated as such. Any company seeking to distribute or sell a pesticide product regulated under FIFRA must obtain a section 3 registration, section 24(c) registration, or a section 18 emergency exemption before it can be distributed or sold in the United States. This proposed rule would codify the Agency's current interpretation of FIFRA, and provides interested parties the opportunity to comment about how it is adding prion to the list of pests in the regulatory definition of pest. This amendment, together with the formal declaration that a prion is a pest, will eliminate any confusion about the status of prion-related products under FIFRA. Codifying the Agency's current interpretation of FIFRA will not change the manner in which EPA currently regulates prion-related products under FIFRA sections 3, 24(c) and 18. Regulating prion-related products under FIFRA is appropriate for protecting human health and the environment against unreasonable adverse effects and ensuring that such products are effective.

          DATES:
          Comments must be received on or before March 28, 2011.

          ADDRESSES:
          Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2010-0427, by one of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
          • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
          • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

            Instructions: Direct your comments to docket ID number EPA-HQ-OPP-2010-0427. EPA's policy is that all comments received will be included in the docket without change and may be made available on-line at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or e-mail. The regulations.gov website is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

            Docket: All documents in the docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305-5805.

          FOR FURTHER INFORMATION CONTACT:

          Jeff Kempter, Antimicrobials Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703) 305-5448; fax number: (703) 308-6467; e-mail address: kempter.carlton@epa.gov.

        SUPPLEMENTARY INFORMATION:
        I. General Information
        A. Does this action apply to me?
        You may be potentially affected by this action if you apply for or own pesticide registrations. Potentially affected entities may include, but are not limited to:
        • Producers of pesticide products (NAICS code 32532).
        • Producers of antimicrobial pesticides (NAICS code 32561).
        • Veterinary testing laboratories (NAICS code 541940).
        • Medical pathology laboratories (NAICS code 621511).
        • Taxidermists, independent (NAICS code 711510).
        • Surgeons (NAICS code 621111).
        • Dental surgeons (NAICS code 621210).
        • Mortician services (NAICS code 812210).
        • Manufacturers of medical tissue devices of human and animal origin (NAICS code undetermined).
        • Manufacturers of other human cellular and tissue products (NAICS code undetermined).
        • Organ banks, body (NAICS code 621991).
        • Plasma, blood, merchant wholesalers (NAICS code 424210).

        This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
        B. What should I consider as I prepare my comments for EPA?
        1. Submitting CBI. Do not submit this information to EPA through regulations.gov or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM 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. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.
        2. Tips for preparing your comments. When submitting comments, remember to:

        i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).
        ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
        iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
        iv. Describe any assumptions and provide any technical information and/or data that you used.
        v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
        vi. Provide specific examples to illustrate your concerns and suggest alternatives.
        vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
        viii. Make sure to submit your comments by the comment period deadline identified.
        II. Background
        A. What action is the Agency taking?

        EPA has decided that under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) a prion is considered to be a pest, and proposes to declare a prion to be a pest and to explicitly include it in the lists of pests in 40 CFR 152.5. These actions would affirm the Agency's authority to regulate products distributed or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., prion-related products). Prion-related products are currently regulated under FIFRA and subject to all requirements and provisions of the Act based on EPA's September 10, 2003 decision that prions share enough characteristics of an “other micro-organism” or “form of life” (as those terms are used in FIFRA) to fall within the scope of FIFRA section 2(t) and 40 CFR 152.5(d). This proposal ensures that the regulatory definition reflects the Agency's authority to regulate products distributed or sold for the purpose of reducing the infectivity of prions on inanimate surfaces (i.e., prion-related products). The primary impact of declaring that a prion is a pest and including “prion” in the regulatory definition of “pest” is to provide regulatory clarity that prion-related products must be registered or exempted under FIFRA sections 3, 24(c), or 18 before such products may be distributed or sold in the United States.

        Note that not all prions and prion-related products are affected by the proposed rule. Firstly, EPA's regulations at 40 CFR 152.5(d) exclude pests “* * * in or on living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs * * * and cosmetics.” Therefore, the proposed rule would not apply to those uses of prion-related products. Secondly, the definition of “pesticide” in FIFRA section 2(u) excludes new animal drugs and liquid chemical sterilants intended for use on a critical or semi-critical device. Accordingly, products which fall into those categories would not be covered by the proposed rule.

        B. What is the Agency's authority for taking this action?
        This action is issued under the authority of sections 2 through 34 of FIFRA (7 U.S.C. 136-136y).
        III. Prion as a Pest Under FIFRA
        A. What is a prion?
        Prions (“proteinaceous infectious particles”) may occur in the central nervous system tissues of animals as an abnormal (“misfolded”), infectious form of prion protein. Prion protein in its normal form, or conformation, can be designated PrPc (“cellular” isoform) while abnormal conformations of prion proteins are generally called prions. Different types of prions are commonly designated by the type of diseases they produce, such as PrPSc (prions associated with scrapie) and PrPBSE (prions associated with bovine spongiform encephalopathy—mad cow disease).

        In the disease process, prions (such as PrPsc) recruit normal prion proteins (PrPc) and convert them into prions (e.g., another copy of PrPSc). This recruitment and conversion process results in the progressive accumulation of disease-producing prions. When this process takes place in the brain, it causes disease that slowly progresses from neuronal dysfunction and degeneration to death. These neurodegenerative prion diseases are known collectively as transmissible spongiform encephalopathies (TSEs). TSEs include scrapie disease in sheep, bovine spongiform encephalopathy (BSE) in cattle, chronic wasting disease (CWD) in deer and elk, kuru and variant Creutzfeld-Jakob Disease (vCJD) in humans, and similar diseases in other animals. EPA and other agencies are concerned that animal-related prions may spread to other animals (e.g., scrapie to sheep, CWD to cervids) or to humans (e.g., BSE), and that human-related prions may be passed to other humans (e.g., kuru or CJD). These diseases are always fatal in humans and animals alike, and there are no known treatments or cures.
        B. Legal/Regulatory Background
        Under section 25(c)(1) of FIFRA, the Administrator, after notice and opportunity for hearing, is authorized “to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the environment.” Therefore, the Agency has the authority to decide whether or not a prion should be considered to be a pest under FIFRA and whether to issue a regulation implementing that decision.

        On September 10, 2003, the EPA decided that a prion should be considered to be a “pest” under FIFRA and that products intended to inactivate prions (i.e., “prion-related products”) should be regulated under FIFRA (Ref. 1). This decision was made partly in connection with the widespread occurrence of chronic wasting disease (CWD) among deer and elk in a number of states, particularly in the Rocky Mountain region. Although CWD had been endemic to that region for a long time, concerns were growing inside and outside of EPA as to how to prevent or minimize the movement of what is believed to be the causative agent for CWD—prions—through the environment.
        At the same time, EPA was receiving inquiries from states about obtaining FIFRA section 18 exemptions to allow use of a disinfectant against prions on inanimate surfaces in government and commercial laboratories. EPA was also aware that the World Health Organization (WHO) recommended the use of sodium hydroxide or sodium hypochlorite for treating surfaces potentially contaminated with prions even though those chemicals were not registered by EPA for that specific purpose. Subsequent to the September 2003 decision, EPA has granted a total of 19 quarantine exemptions under FIFRA section 18 to numerous states (California, Colorado, Maine, Minnesota, Montana, North Dakota, South Dakota, Utah, and Wyoming) and the U.S. Department of Agriculture (USDA) for the use of a commercial aqueous acid phenolic product, Environ LpH, for treatment on hard, nonporous surfaces in government and commercial laboratories contaminated with CWD and other kinds of prions.
        Other Federal agencies are responsible for implementing controls to prevent the spread of prion diseases to animals and humans. For example, to eliminate scrapie within the United States, USDA's Animal and Plant Health Inspection Service (APHIS) administers the national scrapie eradication program (9 CFR parts 54 and 79). APHIS also intends to establish a herd certification program to prevent and control CWD from farmed or captive cervids in the United States (9 CFR parts 55 and 81). In addition, APHIS regulates the importation of animals and animal products into the United States to guard against the introduction of various animal diseases, including BSE (9 CFR parts 92, 93, 94, and 95). To prevent the spread of BSE through animal feed, the Food & Drug Administration (FDA) prohibits the use of most mammalian protein in the manufacture of animal feed used for ruminants and prohibits high risk cattle materials from all animal feed (21 CFR part 589). To prevent potential human exposure to the BSE agent, USDA's Food Safety and Inspection Service prohibits for use as human food cattle materials that could potentially contain the BSE agent (9 CFR 310.22). FDA has also issued an interim final rule (69 FR 42256, July 14, 2004) prohibiting the use of certain cattle materials in human food and cosmetics to address the potential risk of BSE (21 CFR 189.5 and 700.27).
        C. EPA's Interpretation of FIFRA
        1. Applicable FIFRA provisions. FIFRA section 25(c)(1) authorizes the Administrator “to declare a pest any form of plant or animal life (other than man and other than bacteria, virus, and other micro-organisms on or in living man or other living animals) which is injurious to health or the environment.” FIFRA section 2(t) defines a pest, in part, as “* * * any other form of terrestrial or aquatic plant or animal life or virus, bacteria or other micro-organism * * * which the Administrator declares to be a pest under section 25(c)(1).” These FIFRA sections provide EPA the authority to declare an entity to be a “pest” if it meets these statutory provisions.
        2. EPA's interpretation of FIFRA. EPA's decision to declare a prion to be a pest under FIFRA rests on its statutory interpretation of FIFRA sections 25(c)(1) and 2(t). EPA believes that Congress intended that the phrases “any other form of plant or animal life” and “other micro-organism” be broadly interpreted to include biological entities that are injurious to humans or the environment. The following points provide EPA's rationale for this interpretation.
        • In FIFRA, Congress has over the years used the term “other micro-organism” more broadly than most microbiologists currently would define the term because, as used in FIFRA, the term “micro-organism” includes viruses, which many microbiologists do not consider to be microorganisms. Therefore, the term “micro-organism,” as currently defined by many microbiologists, is narrower than the potential scope of the term “other micro-organism” in FIFRA.

        • As used in FIFRA, the term “other micro-organism” includes entities other than viruses and bacteria, but it is unclear which entities. It is reasonable to assume that it includes those entities that most microbiologists currently recognize as microorganisms (i.e., microfungi, yeasts, and protists). Because the statutory language explicitly includes viruses among micro-organisms in the definition of “pest,” the term “other micro-organism” in its statutory context reasonably may be interpreted to include some other entities that many microbiologists may not categorize as microorganisms.

        • Today, microbiologists do not generally classify viruses as microorganisms because they are not alive (i.e., they cannot reproduce sexually or asexually, grow or perform self-maintenance). Therefore, the term “other micro-organism” as used in FIFRA appears broad enough to include some entities that are not alive.
        • Congress' rationale for including viruses within the FIFRA definition of “pest” is not known as there is no available legislative history on this issue. However, it is reasonable to infer that Congress included viruses within the FIFRA definition of “pest” and within the scope of the meaning of “micro-organism” because viruses share important characteristics of other pests. The characteristics of a virus that make it resemble a micro-organism in the context of “pest” are pathogenicity, infectivity, transmissibility, the ability to increase in number, and the ability to evolve. EPA believes that Congress intended the terms “pest” and “other micro-organism” as used in FIFRA to be broadly inclusive.
        • One entity that shares the characteristics of pathogenicity, infectivity, transmissibility, the ability to increase in number, and the ability to evolve (but which, like viruses, is not alive) is the prion. A prion is an infectious agent occurring in the tissues of animals that is widely, though not universally, believed to be composed of an abnormal (misfolded) protein without nucleic acid. Prions are also unquestionably injurious to the health of humans and other animals. They cause TSE diseases that attack the nervous system, inflict irreversible damage, and are always fatal to infected animals and humans. Once introduced into an animal or human host, prions can induce the formation of new prions in the animal or human host. Prions are considered among the most difficult of all biological entities to mitigate and few methods are available for effectively doing so. Moreover, current test methods cannot demonstrate complete destruction or inactivation of prions. For these reasons, EPA believes that the public needs assurance of the safety and efficacy of products intended to reduce the infectivity of prions.
        • Congress expressly included “prion” within another statute's definition of “pest,” namely in the Animal Health Protection Act of 2002.
        For these reasons, EPA concluded that a prion is appropriately included in the phrase “other micro-organism.” Because prions are also severely injurious to human and animal health, EPA has also concluded that a prion is appropriately included in the FIFRA definition of “pest.”
         D. EPA's Prion Science Evaluation and Efficacy Test Guidance Documents
        To assure that this rulemaking is based on the best available scientific information, EPA reviewed and summarized the most relevant scientific studies and publications related to the issue of whether a prion is a pest in a “white paper” (Ref. 2). EPA presented the draft white paper to the FIFRA Scientific Advisory Panel (SAP) for peer review and comment on March 31 and April 1, 2009. The SAP provided comments to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA subsequently responded to the SAP's comments (Ref. 4) and made revisions to the white paper in response to the SAP comments (Ref. 5). All of these referenced documents are available in the docket for this declaration and proposed rule.
        IV. FIFRA Review Requirements
        In accordance with FIFRA section 25(a), EPA has submitted a draft of the proposed rule to the FIFRA SAP, the Secretary of Agriculture (USDA), and appropriate Congressional Committees. In addition, pursuant to FIFRA section 21(b), EPA submitted a draft of the proposed rule to the Secretary of Health and Human Services (HHS).
        The FIFRA SAP waived its review of this proposal on June 1, 2010, because the significant scientific issues involved have already been reviewed by the SAP and additional review is not necessary. A copy of this waiver is available in the docket.
        As required by FIFRA section 25(a), the written comments on the draft proposal received from USDA and HHS, along with EPA responses, are available in the docket. EPA addressed these comments as part of the interagency review process under Executive Order 12866, and changes made to the proposed rule in response to all comments received during that interagency review are documented in the docket as required by Executive Order 12866.
        V. Statutory and Executive Order Reviews
        A. Regulatory Review
        Pursuant to Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has determined that this proposed rule is a “significant regulatory action” because this action might raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this proposed rulemaking to OMB for review under Executive Order 12866. Any changes made in response to OMB comments have been documented in the docket for this rulemaking as required by the Executive Order.

        EPA has prepared an economic analysis of the potential costs associated with this proposed action, entitled Economic Analysis of the Notice of Proposed Rulemaking Concerning the Status of Prion as a Pest under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (Ref. 8). A copy of this document is available in the docket for this rulemaking, and is briefly summarized here.
        The Economic Analysis (EA) presents the Agency's assessment of the potential costs and benefits expected to result from the proposed rule. In terms of benefits, the proposed rule will ensure that EPA can protect human health and the environment by subjecting prion-related products to regulation under FIFRA, including all data and labeling requirements. In terms of costs, using pre-2003 costs as the baseline, the incremental costs of the proposed rule per registration action range from $424,000 to $4.72 million.
        The EA presents the costs of various types of registrations under the proposed rule and presents expected incremental costs for three product registration types. The three types of registration actions which are possible under the proposed rule are the registration of: (1) A new active ingredient, (2) a new use product, or (3) a new use amendment registration.

        The EA estimates that three firms may seek registrations for major new use products in the first year. If all uses are high exposure (e.g., indirect food uses), the maximum potential total cost to industry in the first year would be approximately $7.05 million, and costs per firm would be approximately $2.35 million. Given the uncertainty that characterizes the market for prion-related products at this time, the Agency did not speculate further on the expected number of registrations in subsequent years. However, registrations that occur after the initial major new use product registrations would probably be major new use amendments. Data requirements would entail only product-specific efficacy data for major new use amendments at a cost of approximately $431,000 per registration action. Approximately 80% of the firms in the pesticide manufacturing industry are small firms with revenues of $22 million, on average. A cost of $7.05 million suggests that the incremental cost per firm of $2.35 million dollars would equal nearly 11% of annual revenues. However, after the initial three registrations, a major new use amendment at a cost of $431,000 would represent fewer than 2% of average annual revenues.
        The EA identifies three categories of persons who could be affected by the proposed rule—pesticide registrants, users of prion-related products, and researchers. The registration related requirements under FIFRA, however, are imposed on the entity that registers the prion-related product. Users of prion-related products and researchers are affected indirectly. The EA summarizes potential qualitative impacts of regulating prion-related products that were expressed by product users to EPA during its outreach efforts to these users.
        The EA evaluates the impacts of the data required to support the registration of a prion-related product, specifically the need for a product performance test that will measure the ability of an individual product to reduce the infectivity of prions. The Agency has developed draft test guidelines for prions which will ensure that the Agency receives the data needed to make objective and reliable determinations as to whether a prion-related product meets the Agency's efficacy data requirements for registration. Providing clear guidance on EPA's efficacy data requirements for prion-related products will benefit registrants by enabling them to submit relevant, correct and complete data submissions in support of applications for registration to the Agency.

        One unintended consequence of using products approved for use under FIFRA section 18 exemptions is that at least one state, California, requires that such products be applied only by certified applicators. EPA further understands, however, that California has no such requirement for pesticide products that are registered under FIFRA section 3 or 24(c) that are not classified for restricted use. Hence, laboratories in California that use prion-related products registered under section 3 or 24(c) would not be subject to a certified applicator requirement. The initial cost of obtaining the certified applicator's license in California is $140, and the renewal fee is $60 every 2 years (see http://www.cdpr.ca.gov/docs/license/qac.htm). In addition, 20 hours of continuing education is required to obtain renewal. If a similar requirement is imposed by other states, the cost to laboratories for obtaining applicator licenses would probably be about the same. No such cost is associated with products registered under section 3 or 24(c).
        B. Paperwork Activities
        The information collection requirements, i.e., the paperwork collection activities, contained in this proposal are already approved by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. Specifically, the activities contained in this proposed rule are already addressed in the following information collection requests (ICRs):
        1. The activities associated with the establishment of a tolerance are currently approved under OMB Control No. 2070-0024 (EPA ICR No. 0597).
        2. The activities associated with the application for a new or amended registration of a pesticide are currently approved under OMB Control No. 2070-0060 (EPA ICR No. 0277).

        3. The activities associated with the generation of data in response to a Data-Call-In issued subsequent to registration (e.g., as part of the review of an existing registration), are currently approved under OMB Control No. 2070-0174 (EPA ICR No. 2288).
        The existing ICRs cover the paperwork activities contained in this proposal because the activities already occur as part of existing program activities. These program activities are an integral part of the Agency pesticide program and the corresponding ICRs are regularly renewed. Although this proposal involves already approved activities, the estimated frequency of those activities may increase as a result of this proposal. The total estimated average annual public reporting burden currently approved by OMB for these various activities ranges from approximately 8 hours to 3,000 hours per respondent, depending on the activity and other factors surrounding the particular pesticide product. According to EPA's EA for this proposed rule (Ref. 8), using the estimate of three major new use product registrations in the first year, the additional registration of three antimicrobial products making prion-related claims will result in an increase in new registration applications for the Agency from 140 to 143 and an increase in tolerance petitions of from 64 to 67. The increase in paperwork burden for the registrant will be nearly $38,000 (600 hours for three registrations) for registration activities and a little more than $423,000 (5,200 hours for three registrations) for paperwork for tolerance petitions (Ref. 8).

        An agency may not conduct or sponsor, and a person is not required to respond to an information collection request unless it displays a currently valid OMB control number, or is otherwise required to submit the specific information by a statute. The OMB control numbers for EPA's regulations, after appearing in the preamble of the final rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the related collection instrument (e.g., form or survey).
        Under the PRA, “burden” means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

        Comments are requested on the Agency's need for this information, the accuracy of the burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques. Send comments to EPA as part of your overall comments on this proposed action in the manner specified under ADDRESSES. In the final rule, the Agency will address any comments received regarding the information collection requirements contained in this proposed rule.
        C. Small Entity Impacts

        Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., after considering the potential economic impacts of this proposed rule on small entities, I hereby certify that this proposed rule would not have a significant adverse economic impact on a substantial number of small entities. This determination is based on the Agency's economic analysis (Ref. 8), and is briefly summarized here.

        Under the RFA, small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's proposed rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201 (in this case based on maximum number of employees or sales for small businesses in each industry sector, as defined by a 6-digit NAICS code); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. Since the regulated community does not include small governmental jurisdictions or small not-for-profit organizations, the analysis focuses on small businesses.
        According to the Agency's economic analysis (Ref. 8), only three firms are expected to apply for registrations of prion-related products. One of these firms is known to be a large firm. Given that approximately 79% of the firms in the antimicrobial industry are small firms, it is possible that any or all of the remaining two other firms could qualify as a small entity under the SBA definition.
        The incremental costs of the proposed rule could represent from 2% to 11% of the average annual revenues of a small firm. In general, the Agency does not believe that prion-related products are an important market segment for sodium hydroxide or sodium hypochlorite producing firms and does not anticipate a large number of product registrations beyond the first year the final rule would take effect. If small entities apply to register products for prion control, they would likely pursue a registration where they could likely cite a substantial amount of data and not incur 100% of the initial costs of testing (Ref. 8).
        EPA continues to be interested in the potential impacts of this proposed rule on small entities and welcomes comments on issues related to such impacts.
        D. Unfunded Mandates
        This action does not contain any Federal mandates for State, local, or tribal governments or the private sector under the provisions of Title II of the Unfunded Mandates Reform Act (UMRA), 2 U.S.C. 1531-1538. EPA has determined that this regulatory action will not result in annual expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or for the private sector. As described in Unit IV.A., the incremental costs for the proposed rule are estimated from $424,000 to $4.72 million. Since State, local, and tribal governments are rarely pesticide applicants, the proposed rule is not expected to significantly or uniquely affect small governments. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any affect on small governments. Accordingly, this action is not subject to the requirements of sections 202, 203 or 205 of UMRA.
        E. Federalism Implications
        Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), EPA has determined that this proposed rule does not have “federalism implications” because 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, as specified in the Order. As indicated previously, instances where a state is a registrant are extremely rare. Therefore, this proposed rule may seldom affect a state government. Thus, Executive Order 13132 does not apply to this proposed rule.
        In the spirit of the Order, and consistent with EPA policy to promote communications between the Agency and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.
        F. Tribal Implications
        As required by Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined that this proposed rule does not have “tribal implications” because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in the Order. As indicated previously, at present, no tribal governments hold, or have applied for, a pesticide registration. Thus, Executive Order 13175 does not apply to this proposed rule.
        In the spirit of the Order, and consistent with EPA policy to promote communications between the Agency and State and local governments, EPA specifically solicits comment on this proposed rule from tribal officials.
        G. Children's Health
        EPA interprets Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of Executive Order 13045 has the potential to influence the regulation. This action is not subject to Executive Order 13045 because it does not establish an environmental standard intended to mitigate health or safety risks, and it is not designated as an “economically significant” regulatory action as defined by Executive Order 12866 (see Unit V.A.). To the contrary, this action will provide added protection for children from pesticide risk.
        H. Energy Effects

        This action is not a “significant energy action” as defined in Executive Order 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), because it is not likely to have an effect on the supply, distribution, or use of energy as described in the Order.
        I. Technical Standards

        Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, and sampling procedures) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
        This action does not propose to require any technical standards that would require Agency consideration of voluntary consensus standards. This action proposes the types of data to be required to support the registration of antimicrobial pesticide products with prion-related claims but does not propose to require specific methods or standards to generate those data.

        The Agency invites comment on its conclusion regarding the applicability of voluntary consensus standards to this proposed rulemaking.
        J. Environmental Justice

        This proposed rule does not have an adverse impact on the environmental and health conditions in low-income and minority communities. Therefore, under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), the Agency does not need to consider environmental justice-related issues.
        VI. References
        As indicated under ADDRESSES, a docket has been established for this rulemaking under docket ID number EPA-HQ-OPP-2010-0427. The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA in developing this proposed rule, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical contact listed under FOR FURTHER INFORMATION CONTACT.

          1. U.S. Environmental Protection Agency. 2004. Considerations of Prions as a Pest under FIFRA. Memorandum to The Record from Susan B. Hazen, Principal Deputy Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances. April 29, 2004.
          2. U.S. Environmental Protection Agency. 2009. “Scientific Information Concerning the Issue of Whether Prions Are a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide Act.” Draft dated February 23, 2009.

          3. U.S. Environmental Protection Agency. 2009. Transmittal of Meeting Minutes of the FIFRA Scientific Advisory Panel Meeting Held March 31-April 1, 2009 on Scientific Issues Associated with Designating a Prion as a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods. Memorandum from Myrta R. Christian, Designated Federal Official, FIFRA Scientific Advisory Panel, Office of Science Coordination and Policy, to Debbie Edwards, PhD, Director, Office of Pesticide Programs. June 29, 2009. See http://www.epa.gov/scipoly/sap/meetings/2009/march/033109panelmembers.html.

          4. U.S. Environmental Protection Agency. 2010. EPA Responses to Comments by the FIFRA Scientific Advisory Panel Concerning “Scientific Information Concerning the Issue of Whether Prions Are a `Pest' under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).” February 17, 2010.
          5. U.S. Environmental Protection Agency. 2010. Scientific Information Concerning the Issue of Whether A Prion Is a “Pest” under the Federal Insecticide, Fungicide, and Rodenticide Act. February 17, 2010.
          6. U.S. Environmental Protection Agency. 2009. Product Performance Test Guidelines OPPTS 810.XXXX Products with Prion Related Claims. Draft dated February 23, 2009.
          7. U.S. Environmental Protection Agency. 2009. Product Performance Test Guidelines OPPTS 810.XXXX Products with Prion Related Claims. Draft dated December 8, 2009.
          8. U.S. Environmental Protection Agency. 2010. Economic Analysis of the Notice of Proposed Rulemaking Concerning that Status of a Prion as a Pest under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). February 17, 2010.

          List of Subjects in 40 CFR Part 152
          Environmental protection, Antimicrobial pesticides, Prion.

          Dated: January 14, 2011.
          Lisa P. Jackson,
          Administrator.

        Therefore, it is proposed that 40 CFR chapter I be amended as follows:

          PART 152—[AMENDED]
          1. The authority citation for part 152 continues to read as follows:

            Authority:
             7 U.S.C. 136-136y; subpart U is also issued under 31 U.S.C. 9701.

          2. Section 152.5 is amended by revising paragraph (d) to read as follows:

            § 152.5
            Pests.

            (d) Any fungus, bacterium, virus, prion, or other microorganism, except for those on or in living man or other living animals and those on or in processed food or processed animal feed, beverages, drugs (as defined in FFDCA section 201(g)(1)) and cosmetics (as defined in FFDCA section 201(i)).

      [FR Doc. 2011-1636 Filed 1-25-11; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        [Docket No. FWS-R2-ES-2012-0101; 4500030113]
        RIN 1018-AY25
        Endangered and Threatened Wildlife and Plants; 6-Month Extension of Final Determination for the Proposed Listing of the Zuni Bluehead Sucker as an Endangered Species

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Proposed rule; reopening of comment period.

          SUMMARY:

          We, the U.S. Fish and Wildlife Service (Service), announce a 6-month extension of the deadline for a final determination concerning the listing of the Zuni bluehead sucker (Catostomus discobolus yarrowi) as an endangered species. We also reopen the comment period on the proposed rule to list this species as an endangered species. We are taking this action because there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to our determination regarding the proposed listing rule, making it necessary to solicit additional information by reopening the comment period for 30 days.

          DATES:

          The comment period end date is February 10, 2014. If you comment using the Federal eRulemaking Portal (see ADDRESSES), you must submit your comment by 11:59 p.m. Eastern Time on the closing date.

          ADDRESSES:
          You may submit written comments by one of the following methods:
          (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R2-ES-2012-0101, which is the docket number for the proposed rule to list the Zuni bluehead sucker as endangered. Then, in the Search panel on the left side of the screen, under the Document Type heading, check on the Proposed Rules link to located the proposed rule. You may submit a comment by clicking on “Comment Now!”
          (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R2-ES-2012-0101; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, MS 2042-PDM; Arlington, VA 22203.

          We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see the Public Comments section below for more information).

          FOR FURTHER INFORMATION CONTACT:
          Wally “J” Murphy, Field Supervisor, U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office, 2105 Osuna NE., Albuquerque, NM 87113; by telephone 505-346-2525; or by facsimile 505-346-2542. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.

        SUPPLEMENTARY INFORMATION:
        Background

        The Zuni bluehead sucker is a small fish that is believed to be endemic to streams in east-central Arizona and west-central New Mexico. On January 25, 2013, we published in the Federal Register a proposed rule (78 FR 5369) to list the Zuni bluehead sucker (Catostomus discobolus yarrowi) as an endangered species under the Endangered Species Act of 1973, as amended (Act; 16 U.S.C. 1531 et seq.), because we found the subspecies in danger of extinction. On the same date, we also published in the Federal Register a proposed rule to designate critical habitat for the Zuni bluehead sucker (78 FR 5351; January 25, 2013). Identified threats to the subspecies included water withdrawals, sedimentation, impoundments, housing development, and predation by nonnative green sunfish (Lepomis cyanellus). We believe the range of the subspecies has already been reduced by approximately 90 percent in New Mexico, but we do not know the extent of potential range reduction in Arizona. Low water levels from drought and water withdrawals in remaining occupied streams have reduced the available habitat for the subspecies. The proposed listing rule had a 60-day comment period, ending March 26, 2013. For a description of previous Federal actions concerning the Zuni bluehead sucker, please refer to the proposed listing rule (78 FR 5369; January 25, 2013). Since the publication of the proposed rules, we have found substantial scientific disagreement about the status of the Zuni bluehead sucker as explained below, and we are therefore reopening the comment period for the proposed listing rule and extending the schedule for the final determination for 6 months in order to solicit and analyze information that will help to clarify these issues.
        Section 4(b)(6) of the Act and its implementing regulations at 50 CFR 424.17(a) require that we take one of three actions within 1 year of a proposed listing: (1) Finalize the proposed listing; (2) withdraw the proposed listing; or (3) extend the final determination by not more than 6 months, if there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the determination. Our review of the information described below suggests there is substantial disagreement regarding the taxonomic status of some populations that we considered Zuni bluehead sucker in the proposed rule. The following discussion describes these disagreements.

        In the proposed listing rule, we reported that the Zuni bluehead sucker has been documented in three discrete watersheds—the Zuni River watershed in New Mexico, the Little Colorado River watershed in Arizona, and the San Juan River watershed at the borders of New Mexico and Arizona. However, the taxonomy of the occurrences of the subspecies outside of the Zuni River watershed has been disputed and remains in question. In the Zuni River watershed of New Mexico, the subspecies is believed to be restricted to three isolated populations in the upper Rio Nutria drainage (Carman 2008, pp. 2-3). Streams in the upper Rio Nutria drainage of the Zuni River watershed include the Rio Nutria, Cebolla Creek, and Rio Pescado, in addition to Tampico Spring and Agua Remora Springs, which are headwater springs to Rio Nutria. In eastern Arizona, there is evidence that the subspecies occurs in low numbers in the Kinlichee Creek area of the Little Colorado River watershed and Canyon de Chelly area of the San Juan River watershed (Hobbes 2000, pp. 9-16; Albert 2001, pp. 10-14; David 2006, p. 35). Both the Kinlichee Creek and Canyon de Chelly areas occur on the Navajo Nation. Streams in the Kinlichee Creek area include Red Clay Wash, Black Soil Springs, Scattered Willow Wash, and Kinlichee Creek itself. Streams in the Canyon de Chelly area include Tsaile Creek, Sonsela Creek, Crystal Creek, Coyote Wash, Whiskey Creek, and Wheatfields Creek. These streams originate along the western slope of the Chuska Mountains in New Mexico, flow through Arizona, and eventually flow into the San Juan River. It is the taxonomic status of these populations in the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly areas in the San Juan River watershed that is in question. A map for geographical reference is available for review on the New Mexico Ecological Services Field Office Web site at http://www.fws.gov/southwest/es/NewMexico/.

        During the public comment period on the proposed listing rule, we received multiple comments regarding our interpretation of scientific literature related to the genetics of the Zuni bluehead sucker. Commenters were particularly concerned with whether or not populations on the Navajo Nation, which include the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly area of the San Juan River watershed, that were recognized in the proposed rule as Zuni bluehead suckers are appropriately classified as such rather than a different subspecies of the bluehead sucker (see Taxonomy and Genetics section, below). In addition, since the closing of the comment period, we have received additional information and genetic analyses of the bluehead sucker populations found on lands of the Navajo Nation, including both the Kinlichee Creek area and the Canyon de Chelly area (Unmack et al. 2012, entire; Hopken et al. 2013, entire; Douglas et al. 2013, entire). In particular, both the Hopken et al. (2013) and Douglas et al. (2013) reports find that the populations on the Navajo Nation should not be categorized as Zuni bluehead sucker, thereby contradicting the information we presented in the proposed rule. This new information and data, along with input we received during the comment period, have led to substantial scientific disagreement about the status of these populations as explained in more detail below.
        In conclusion, section 4(b)(6) of the Act allows the Service to extend the final determination by not more than 6 months, if there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the determination. In light of the substantial disagreement regarding the taxonomic status of some populations that we considered Zuni bluehead sucker in the proposed listing rule, we are reopening the comment period for the proposed listing rule and extending the schedule for the final determination for 6 months in order to solicit and analyze information that will help to clarify these issues. We will make a final determination no later than July 25, 2014.
        Taxonomy and Genetics

        Although there is disagreement regarding where the Zuni bluehead sucker occurs, our review of the available information has concluded that the Zuni bluehead sucker is a valid subspecies. It is believed that the first specimen of the Zuni bluehead sucker was collected from the Zuni River near Zuni Pueblo in McKinley County, New Mexico, in 1873 (Cope 1874, p. 138). The next collection was made in 1926, from the Zuni River, near Zuni Pueblo (Propst et al. 2001, p. 159). It was not subsequently collected in New Mexico until W.J. Koster (University of New Mexico, Museum of Southwestern Biology) collected the species in the Rio Pescado in 1948, and in the Rio Nutria in 1960 (Propst 1999, p. 49; Propst et al. 2001, p. 159).

        The Zuni bluehead sucker subspecies is believed to have originated as a hybrid of the Rio Grande sucker (Catostomus plebeius) and the bluehead sucker (C. discobolus) from the Little Colorado River. Historically, the bluehead sucker occurred in streams and rivers in Idaho, Wyoming, Colorado, Arizona, and New Mexico. Gerald R. Smith (University of Michigan) was the first person to provide evidence for the hybrid origin of the Zuni bluehead sucker (Smith 1966, pp. 87-90). Smith (1966, pp. 87-90) and Smith et al. (1983, pp. 37-38) hypothesized that the subspecies resulted from a prehistoric geological event in which two species of sucker that were formerly geographically separated came into contact with one another in the late Pleistocene (which occurred more than 11,700 years ago) and exchanged genes through hybridization over some time. Since collections of Zuni bluehead suckers occurred as early as 1873, Smith (1966, p. 88) discounted that the origin of the subspecies could be a product of human translocation and, instead, proposed that a stream capture occurred causing the two suckers to come into contact. A stream capture is a geomorphological phenomenon occurring when a river drainage system or watershed is diverted from its own bed and flows instead down the bed of a neighboring stream. During this particular stream capture, part of the headwaters of San Jose Creek (a Rio Puerco—Rio Grande tributary where Rio Grande sucker occurred) were brought into the headwaters of the Zuni River (a Little Colorado River tributary where bluehead sucker occurred); this caused Rio Grande suckers from San Jose Creek to intermingle with resident bluehead suckers in the Zuni River (Smith et al. 1983, p. 45). Unmack et al. (2012, p. 29) estimated that the introgression (gene flow from one species into the gene pool of another species) between the Rio Grande sucker and bluehead sucker occurred about 1.1 million years ago based on aging fossils.
        In 1983, Smith et al. (entire) formally designated Zuni bluehead sucker as a subspecies. Based on a review of morphological (pertaining to the physical form and structure of the fish), meristic (quantitative features of fish, such as fins or scales), and biochemical genetic data, Smith et al. (1983, pp. 1, 45-47) determined that that the Zuni bluehead sucker subspecies is an intermediate between Rio Grande sucker and bluehead sucker, with the Rio Nutria population (Zuni River watershed) characters (characters are attributes or features that distinguish a subspecies, such as coloration) more like Rio Grande sucker and Kinlichee Creek (Little Colorado River watershed) characters more like bluehead sucker. Based on morphology, they assigned fish samples in Kinlichee Creek (Little Colorado River watershed) as Zuni bluehead suckers and Whiskey Creek fish samples (in the Canyon de Chelly area of the San Juan River watershed) as bluehead suckers. However, Smith et al. (1983, p. 46) could not genetically differentiate Kinlichee Creek samples from Whiskey Creek fish samples. In other words, based on genetics, fish from Kinlichee Creek (Little Colorado River watershed) and Whiskey Creek (in the Canyon de Chelly area of the San Juan River watershed) are the same.

        Further study by Crabtree and Buth (1987, p. 843) replicated and expanded upon the Smith et al. (1983, entire) genetic analysis and reevaluated their data and interpretation. This study provided supporting evidence confirming assignment of populations in the Zuni River headwater streams as the Zuni bluehead sucker subspecies based on the presence of unique alleles at several loci (loci are specific locations of a gene or DNA sequence on a chromosome). However, they recognized that Smith et al. (1983, pp. 42, 46) attributed a broader geographical range to the Zuni bluehead sucker. The genetic analysis by Crabtree and Buth (1987, p. 852) did not support the geographical range identified by Smith et al. (1983, pp. 42, 46). Crabtree and Buth (1987, pp. 851-852) suggested that the genetic interaction between the Rio Grande sucker and bluehead sucker is limited to the upper Rio Nutria populations in the Zuni River watershed. Thus, the findings of Crabtree and Buth (1987, entire) suggest that the Zuni bluehead sucker subspecies occurs only in the Zuni River watershed of New Mexico.

        Our analysis of morphological and genetic information supports the recognition of the Zuni bluehead sucker as being distinct from both the Rio Grande sucker and the bluehead sucker (Smith 1966, pp. 87-90; Smith et al. 1983, pp. 37-38; Crabtree and Buth 1987, p. 843; Propst 1999, p. 49). Based on our review of the best available scientific and commercial data, we concluded in the proposed listing rule that the Zuni bluehead sucker is a valid subspecies.
        Although the Zuni bluehead sucker is a valid taxon, there is substantial disagreement as to which populations of the fish should be assigned to the Zuni bluehead sucker subspecies based on various interpretations of the morphological and genetic analyses. In the discussion below, we review the results of three recent studies related to the evolutionary relationships of the populations we have considered to be Zuni bluehead sucker.
        In 2012, Thomas Dowling (a geneticist at Arizona State University) presented the Schwemm and Dowling (2008, entire) data that some bluehead sucker found in the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly area of the San Juan River watershed also contain Rio Grande sucker alleles, suggesting that these fish may be the result of the introgression between Rio Grande sucker and bluehead sucker described above (Service 2012, entire). Schwemm and Dowling (2008, entire) investigated the extent of introgression of Rio Grande sucker within bluehead sucker within the Little Colorado River drainage (Kinlichee Creek area and Zuni River watershed area) and San Juan River drainage (Canyon de Chelly area) through analysis of both mitochondrial and nuclear DNA sequences. The mitochondrial DNA analysis identified three distinct lineages (ancestry) and one distinct sublineage: (1) Mainstem Colorado River/San Juan River bluehead sucker lineage; (2) Canyon de Chelly bluehead sucker sublineage (in San Juan River watershed); (3) Little Colorado River bluehead sucker lineage; and (4) Rio Grande sucker lineage. The Rio Grande sucker lineage was found in only one upper Little Colorado River population: the Rio Nutria of the Zuni River watershed in New Mexico. However, the nuclear DNA not only identified Rio Grande sucker alleles in the Rio Nutria in New Mexico (consistent with mitochondrial DNA analysis), but also identified Rio Grande sucker alleles in bluehead sucker populations in Black Soil Springs and in Kinlichee Creek as it flows through Bear Canyon (both populations are in the Kinlichee Creek area of the Little Colorado River watershed), and in Wheatfields Creek (in the Canyon de Chelly area of the San Juan River watershed). Therefore, the nuclear DNA analysis presented by Dowling in 2012 suggests that, based on the presence of Rio Grande sucker alleles (via nuclear DNA), the Zuni bluehead sucker subspecies occurs in certain streams of all three watersheds: the Zuni River watershed, the Little Colorado River watershed, and the San Juan River watershed.
        Unmack et al. (2012, p. 20) assigned Zuni bluehead sucker to a complex (group of related species) of ancient Arizona and New Mexico lineages that share molecular, meristic, and osteological (osteology is the study of bone structure and function) characteristics of bluehead sucker and Rio Grande sucker. Their study included populations found in the headwaters of the San Juan and Little Colorado Rivers (including the Zuni River headwaters) in northeastern Arizona. This assignment was based on the information provided above (Smith 1966, entire; Smith et al. 1983, entire; Crabtree and Buth 1987, entire; Schwemm and Dowling 2008, entire). Their assignment suggests that the Zuni bluehead sucker subspecies originated from three separate but adjacent drainages (San Juan River, Little Colorado River, and the Rio Grande) in the Pleistocene via multiple stream captures. Therefore, the Zuni bluehead sucker subspecies is not restricted to the headwaters of the Zuni River watershed, but includes others areas in the Little Colorado River (Kinlichee Creek area) and San Juan River drainages (Canyon de Chelly area).
        Hopken et al. (2013, entire) published a paper after the publication of the proposed listing rule that evaluates bluehead suckers rangewide using both mitochondrial and nuclear DNA to infer evolutionarily significant units and management units. These researchers looked at 39 sampling locations; however, only 2 (Canyon de Chelly in the San Juan River watershed and Agua Remora in the Zuni River watershed) were relevant to the Zuni bluehead sucker. The mitochondrial DNA only detected bluehead sucker haplotypes (combination of alleles at adjacent locations on a chromosome) in Canyon de Chelly (San Juan River watershed in Arizona) and Agua Remora (Zuni River watershed in New Mexico). Results are consistent with the Schwemm and Dowling (2008, pp. 7-10) mitochondrial DNA analysis of the fish in the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly area of the San Juan River watershed, both of which are located within the Navajo Nation. Similar results were concluded for both Agua Remora and Tampico Springs in the Zuni River watershed of New Mexico (Turner and Wilson 2009, p. 8). Conversely, the nuclear DNA (via microsatellites) analyses by both Schwemm and Dowling (2008, entire) and Turner and Wilson (2009, p. 8) found alleles related to both bluehead and Rio Grande suckers, albeit in low frequency for Agua Remora and Tampico Springs in the Zuni River watershed of New Mexico. Note that these results were based on one specific microsatellite, whereas the Hopken et al. (2013, entire) nuclear DNA test analyzed 16 different microsatellites to identify levels of introgression with other species of suckers known to hybridize with bluehead suckers (e.g., Rio Grande sucker) and tested distinctiveness of the bluehead sucker across several drainages. Hopken et al. (2013, p. 966) did not find fish in the Canyon de Chelly area of the San Juan River watershed or in Agua Remora of the Zuni River watershed to be introgressed and, therefore, concluded that fish from both sampling locations belonged to the bluehead sucker species of the Colorado River rather than the Zuni bluehead sucker subspecies. Canyon de Chelly in the Little Colorado River watershed and Agua Remora in the Zuni River watershed were both identified to have distinct gene pools from one another and other bluehead suckers (Hopken et al. 2013, p. 966). In other words, the Hopken et al. (2013, entire) paper indicates that the populations in the Little Colorado River watershed and Zuni River watershed are geographically isolated and reflect low gene flow. These results are in disagreement with the results of the nuclear DNA analysis provided by Dowling in his 2012 presentation of the Schwemm and Dowling (2008, entire) report.

        Despite their analysis of the Canyon de Chelly populations (San Juan River watershed) of bluehead suckers, Hopken et al. (2013, entire) did not analyze the Kinlichee Creek populations within the Little Colorado River watershed in Arizona. In cooperation with the Navajo Nation, the Service collected additional genetic tissue samples for analysis in 2013. Douglas et al. (2013, entire) used these additional genetic tissue samples to expand upon the Hopken et al. (2013, entire) paper results, applying the same methods. The results of the mitochondrial DNA analysis by Douglas et al. (2013, pp. 19-20) were very similar to Hopken et al. (2013) for samples within the Navajo Nation (Kinlichee Creek area of the Little Colorado River watershed and Canyon de Chelly area of the San Juan River watershed), except a third bluehead sucker haplotype was identified and the Rio Grande sucker haplotype was present in Rio Nutria in the Zuni River watershed in New Mexico. This is consistent with Schwemm and Dowling (2008, entire). As in Hopken et al. (2013, p. 966), Douglas et al. (2013, pp. 15-16) evaluated levels of introgression with other species of suckers known to hybridize with bluehead sucker (e.g., Rio Grande suckers) and tested for distinctiveness between the Zuni River watershed populations and populations in the Little Colorado River watershed and the San Juan River watershed, and they compared the results with other drainages of the Colorado River Basin (Colorado River in the Grand Canyon and Upper Colorado River areas in Utah, Colorado, and Wyoming). No introgression was detected with any other suckers, except for samples from Rio Nutria, which exhibited genotypes of a mixed origin consistent with the subspecies assignment. These results suggest that the Zuni bluehead sucker is restricted to the Zuni River watershed. In addition to Hopken et al. (2013, entire), Douglas et al. (2013, p. 16) identified one more population of bluehead suckers that constitutes a unique gene pool (Kinlichee Creek in the Little Colorado River watershed). These combined results conclude that bluehead suckers from the headwaters of the Little Colorado River watershed (Zuni River area where the Zuni bluehead sucker recognized subspecies occurs and Kinlichee Creek area) and the San Juan River watershed (Canyon de Chelly area) are distinct from each other and any other bluehead suckers within the species' range.
        Since the publication of the proposed rule to list the Zuni bluehead sucker as an endangered species (78 FR 5369; January 25, 2013), there has been substantial disagreement regarding whether the bluehead suckers found within the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly area of the San Juan River watershed are appropriately characterized as Zuni bluehead suckers. This has led to substantial disagreement regarding the current range of the subspecies in Arizona and New Mexico.

        As illustrated by the above discussion, the best available scientific information is unclear as to which populations of fish should be attributed to the Zuni bluehead sucker subspecies. Some studies support that Zuni bluehead sucker subspecies occurs only in the Rio Nutria within the Zuni River watershed in New Mexico (Crabtree and Buth 1987,entire; Hopken et al. 2013, entire; Douglas et al. 2013, entire), whereas other studies support that Zuni bluehead sucker is also found in the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly areas of the San Juan River watershed (Smith et al. 1983, entire; Schwemm and Dowling 2008, entire; Unmack et. al. 2012, p. 20). All of the literature discussed in this document and a map for geographical reference is available for review on the New Mexico Ecological Services Field Office Web site at http://www.fws.gov/southwest/es/NewMexico/.

        As discussed earlier, section 4(b)(6) of the Act and its implementing regulations at 50 CFR 424.17(a) require that we take one of three actions within 1 year of a proposed listing: (1) Finalize the proposed listing; (2) withdraw the proposed listing; or (3) extend the final determination by not more than 6 months, if there is substantial disagreement regarding the sufficiency or accuracy of the available data relevant to the determination. Therefore, in consideration of the substantial disagreements surrounding the Zuni bluehead sucker's taxonomic status in some locations, we are extending the final determination for 6 months in order to solicit and analyze additional information that will help to clarify these issues. Consequently, our final determination on the critical habitat designation for the Zuni bluehead sucker will be also delayed until we make a final listing determination for this subspecies. Therefore, we will make a final determination on the proposed listing rule no later than July 25, 2014.
        Public Comments

        We will accept written comments and information during this reopened comment period on our proposed listing for the Zuni bluehead sucker that was published in the Federal Register on January 25, 2013 (78 FR 5369). We will consider information and recommendations from all interested parties. We intend that any final action resulting from the proposals be as accurate as possible and based on the best available scientific and commercial data.
        In consideration of the disagreements surrounding the data used to support the proposed rulemaking, we are extending the final determination for 6 months in order to solicit information that will help to clarify these issues. In addition to the information requested in the proposed listing rule, we are particularly interested in new information and comments regarding:
        (1) The historical and current status and distribution of the Zuni bluehead sucker, its biology and ecology, specific threats (or lack thereof) and regulations that may be addressing those threats, and ongoing conservation measures for the subspecies and its habitat.
        (2) Whether or not the populations in the Kinlichee Creek area of the Little Colorado River watershed and the Canyon de Chelly area of the San Juan River watershed should be considered the Zuni bluehead sucker subspecies.
        (3) Additional information relevant to the genetic analysis of Zuni bluehead sucker populations.
        (4) Additional information relevant to the morphology of Zuni bluehead sucker populations.
        (5) Information regarding genetic disagreements related to other suckers or similar species of fish that could be used as a surrogate to better understand the genetics of Zuni bluehead sucker

        (6) An explanation for the apparent discrepancy between nuclear DNA analyses. We are seeking clarification to explain the presence of Rio Grande sucker alleles by using a singular microsatellite marker (Schweem and Dowling 2008) whereas 16 different microsatellites did not detect any Rio Grande sucker alleles (Douglas et al. 2013).

        (7) An explanation for the overlap in morphological characteristics in Smith et al. (1983, entire) where he assigned bluehead suckers in Kinlichee Creek (the Little Colorado River watershed) as Zuni bluehead sucker.
        If you previously submitted comments or information on the proposed listing rule, please do not resubmit them. We have incorporated them into the public record, and we will fully consider them in the preparation of our final determination. Our final determination concerning this proposed listing will take into consideration all written comments and any additional information we receive.

        You may submit your comments and materials concerning the proposed rule by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.
        If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the Web site. We will post all hardcopy comments on http://www.regulations.gov as well. If you submit a hardcopy comment that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so.

        Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule, will be available for public inspection on http://www.regulations.gov at Docket No. FWS-R2-ES-2012-0101, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT). You may obtain copies of the proposed rule on the Internet at http://www.regulations.gov at Docket No. FWS-R2-ES-2012-0101, or by mail from the New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).
        References Cited

        A complete list of references cited and a geographical reference map in this rulemaking is available on the Internet at http://www.regulations.gov and http://www.fws.gov/southwest/es/NewMexico/ and upon request from the New Mexico Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).
        Authority

        The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531 et seq.).

          Dated: December 30, 2013.
          Stephen Guertin,
          Acting Director, Fish and Wildlife Service.

      [FR Doc. 2014-00164 Filed 1-8-14; 8:45 am]
      BILLING CODE 4310-55-P


        LIBRARY OF CONGRESS
        Copyright Office
        37 CFR Part 201
        [Docket No. RM 2010-3]
        Refunds Under the Cable Statutory License

          AGENCY:
          Copyright Office, Library of Congress.

          ACTION:
          Notice of Proposed Rulemaking.

          SUMMARY:
          The Office seeks comment on whether a cable operator may receive refunds in situations where it has failed to pay for the carriage of distant signals on a system-wide basis under the Copyright Act, before it was amended to allow a cable system to calculate its royalty fees on a community-by-community basis.

          DATES:
          Written comments must be received in the Office of the General Counsel of the Copyright Office no later than November 3, 2010. Reply comments must be received in the Office of the General Counsel of the Copyright Office no later than November 3, 2010.

          ADDRESSES:
          If hand delivered by a private party, an original and five copies of a comment or reply comment should be brought to the Library of Congress, U.S. Copyright Office, Room 401, 101 Independence Avenue, SE, Washington, DC 20559, between 8:30 a.m. and 5 p.m. E.D.T. The envelope should be addressed as follows: Office of the General Counsel, U.S. Copyright Office. If delivered by a commercial courier, an original and five copies of a comment or reply comment must be delivered to the Congressional Courier Acceptance Site (“CCAS”) located at 2nd and D Streets, NE, Washington, DC between 8:30 a.m. and 4 p.m. The envelope should be addressed as follows: Office of the General Counsel, U.S. Copyright Office, LM 403, James Madison Building, 101 Independence Avenue, SE, Washington, DC 20559. Please note that CCAS will not accept delivery by means of overnight delivery services such as Federal Express, United Parcel Service or DHL. If sent by mail (including overnight delivery using U.S. Postal Service Express Mail), an original and five copies of a comment or reply comment should be addressed to U.S. Copyright Office, Copyright GC/I&R, P.O. Box 70400, Washington, DC 20024.

          FOR FURTHER INFORMATION CONTACT:
          Ben Golant, Assistant General Counsel, and Tanya M. Sandros, Deputy General Counsel, Copyright GC/I&R, P.O. Box 70400, Washington, DC 20024. Telephone: (202) 707-8380. Telefax: (202) 707-8366.

        SUPPLEMENTARY INFORMATION:

        Section 111 of the Copyright Act (“Act”), title 17 of the United States Code (“Section 111”), provides cable operators with a statutory license to retransmit to the public a performance or display of a work embodied in a primary transmission made by a television station licensed by the Federal Communications Commission (“FCC”). Cable systems that retransmit broadcast signals in accordance with the provisions governing the statutory license set forth in Section 111 are required to pay royalty fees to the Copyright Office (“Office”). Payments made under the cable statutory license are remitted semi-annually to the Office which invests the royalties in United States Treasury securities pending distribution of these funds to those copyright owners who are entitled to receive a share of the fees. Section 111 was recently amended by the Satellite Television Extension and Localism Act of 2010 (“STELA”), Pub. L. No. 111-175, which made some changes to the design of the royalty payment structure, as noted below.

        Cable operators have long paid royalties for the retransmission of non-network programming carried by distant broadcast television signals under the Section 111 statutory license. The royalties are based on a percentage of gross receipts generated by a cable system. Under the licensing framework established by Congress in 1976, cable operators had to pay for the number of distant signals carried, even though some such signals were not received or made available to every subscriber of a particular cable system. Distant broadcast signals that were not made available on a system-wide basis, but on which operators were required to pay royalties, have been called “phantom signals.” The Copyright Office has been aware of the phantom signal situation since at least 1983, see NCTA Petition for Issuance of Notice of Proposed Rulemaking (filed August 22, 1983), but the matter has only recently received legislative attention.
        Section 104 of STELA, entitled “Modifications to Cable System Secondary Transmission Rights Under Section 111,” directly addresses phantom signals. Specifically, it amends Section 111(d)(1) of the Copyright Act which sets forth the methodology for a cable operator to calculate royalty fees. Cable operators now pay royalty fees based on the communities where the distant broadcast signal is actually offered rather than on a broader cable system basis as had been the case since 1978.
        Specifically, STELA amends subparagraph (C) of Section 111(d)(1) to state that if a cable system provides secondary transmissions of primary transmitters to some, but not all, communities served by the cable system, the gross receipts and distant signal equivalent values for each secondary transmission may be derived on the basis of the subscribers in those communities where the cable system actually provides such secondary transmission. Where a cable system calculates its royalties on a community-specific (“subscriber group”) basis, the operator applies the methodology in Section 111(d)(1)(B)(ii)-(iv) to calculate a separate royalty for each subscriber group.
        The legislation also amends subparagraph (D) of Section 111(d)(1) to state that:

          A cable system that, on a statement submitted before the date of the enactment of the Satellite Television Extension and Localism Act of 2010, computed its royalty fee consistent with the methodology under subparagraph (C)(iii), or that amends a statement filed before such date of enactment to compute the royalty fee due using such methodology, shall not be subject to an action for infringement, or eligible for any royalty refund or offset, arising out of its use of such methodology on such statement.

          In other words, operators who have heretofore based royalty payments on subscriber group calculations will not face liability for having done so. The amendments also make clear that cable operators who have paid for phantom signals in the past are not entitled to now seek refunds or offsets for those payments in any Statement of Account period from 2010/1 onward. With regard to offsets, cable operators cannot deduct the amount they paid for a phantom signal prior to STELA (e.g., 2009/1) from the royalties they must pay in future Statement of Account periods.

        While STELA eliminates the possibility of an action for infringement against those cable systems that did not pay for the carriage of phantom signals historically, it did not alter how a cable system was to calculate its royalty fee obligation for carriage of these signals under Section 111 prior to the passage of this legislation. Nevertheless, certain cable systems have concluded that the language which prevents a copyright owner from bringing an infringement suit against a cable system which had computed its past royalty fee obligation in a manner consistent with the methodology in new Section 111(d)(1)(D) also nullifies their obligation to have paid for carriage of all signals on a system-wide basis for the accounting periods ending prior to January 1, 2010. This approach represents one interpretation of the effect of the new provision, but it is not the only one. A more literal reading of the new statutory language is that it only shields a cable system from an infringement action and that it does not erase a cable system's obligation to have paid for the carriage of each distant signal on a system-wide basis prior to the 2010/1 accounting period. Under the latter interpretation, any underpayment for carriage of a phantom signal still remains even though the operator cannot be sued for infringement under Section 111.

        We raise this issue because some cable systems which, prior to the 2010/1 accounting period, did not pay for carriage of phantom signals are now requesting refunds in cases where there are other non-related issues. In these cases, the cable system is just now replying to a pending Licensing Division initiated letter and is requesting a refund for a reporting mistake, e.g., identifying a local signal as a distant signal for the 2009/2 accounting period (or an earlier accounting period), even though, according to the Copyright Office's examination of the statement of account, the cable system still has an outstanding royalty fee obligation for the retransmission of a phantom signal during the same period.
        At this time, the Office is not inclined to refund any fees for a non-phantom reporting error in the case where the operator has an outstanding balance owed for the carriage of a phantom signal without accounting for that obligation too because, prior to STELA, section 111 required that royalty fees be calculated on a system-wide basis. Moreover, the language in STELA protecting a cable system from an infringement suit for failure to make these payments prior to the 2010/1 accounting period does not address a cable system's past obligation to have paid the royalty fees owed by the cable system at the time it filed the statement of accounts. Historically, cable operators have been expected to pay for each distant signal on a system-wide basis and when that did not occur, the Office would write to the cable system noting the underpayment and record it as an outstanding obligation. Moreover, the Office would not provide a refund for an overpayment for misreporting a local signal as a distant signal or similar reporting error until the outstanding obligation for carriage of the phantom signal had been satisfied. Nothing in the legislation appears to have altered this approach. Nevertheless, in light of the requests from certain cable operators, we seek comment on whether to offset the outstanding balance owed for carriage of phantom signals before providing a refund for an error unrelated to phantom signals that occurred in an accounting period prior to 2010/1.

          List of Subjects in 37 CFR 201
          Copyright

        Proposed Regulation
        For the reasons set forth in the preamble, the Copyright Office proposes to amend part 201 of title 37 of the Code of Federal Regulations as follows:
        PART 201 - GENERAL PROVISIONS
        1. The authority citation for part 201 continues to read as follows:

          Authority:
          17 U.S.C. 702

          2. Amend section 201.17 by redesignating paragraphs (m)(1) through (4) as paragraphs (m)(2) through (5) and adding a new paragraph (m)(1) to read as follows:

        § 201.17 Statements of Account covering compulsory licenses for secondary transmissions by cable systems.
        (m) Corrections, supplemental payments and refunds.
        (1) Royalty fee obligations under 17 U.S.C. 111 prior to the effective date of the Satellite Television Extension and Localism Act of 2010, Pub.L. No. 111-175 are determined based on carriage of each distant signal on a system-wide basis. Refunds for an overpayment of royalty fees for an accounting period prior to January 1, 2010, shall be made only when all outstanding royalty fee obligations have been met, including those for carriage of each distant signal on a system-wide basis.

          Dated: September 28, 2010
          Tanya Sandros,
          Deputy General Counsel,
          U.S. Copyright Office.

      [FR Doc. 2010-24779 Filed 10-1-10; 8:45 am]
      BILLING CODE 1410-30-S