        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 372
        [TRI-2005-0004; FRL-7532-4]
        RIN 2025-AA17
        Addition of Diisononyl Phthalate Category; Community Right-to-Know Toxic Chemical Release Reporting; Notice of Data Availability

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule, notice of data availability.

          SUMMARY:
          On September 5, 2000, EPA issued a proposed rule, in response to a petition filed under section 313(e)(1) of the Emergency Planning and Community Right-to-Know Act (EPCRA), to add a diisononyl phthalate (DINP) category to the list of toxic chemicals subject to the reporting requirements under EPCRA section 313 and section 6607 of the Pollution Prevention Act (PPA). EPA proposed to add this chemical category to the EPCRA section 313 toxic chemical list pursuant to its authority to add chemicals and chemical categories because EPA believes this category meets the EPCRA section 313(d)(2)(B) toxicity criterion. The purpose of today's action is to inform interested parties that, in an effort to ensure adequate opportunities for input from all affected parties, EPA is making available for public comment a revised hazard assessment for DINP.

          DATES:
          Comments must be received on or before September 12, 2005.

          ADDRESSES:
          Submit your comments, identified by Docket ID No. TRI-2005-0004, by one of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the on-line instructions for submitting comments.
          • Agency Web site: http://www.epa.gov/edocket. EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow the on-line instructions for submitting comments.
          • E-mail: oei.docket@epa.gov.

          • Mail: Office of Environmental Information (OEI) Docket, Environmental Protection Agency, Mail Code: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC, 20460, Attention Docket ID No. TRI-2005-0004.
          • Hand Delivery: EPA Docket Center, (EPA/DC) EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC, 20004, telephone: 202-566-1744, Attention Docket ID No. TRI-2005-0004. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

            Instructions: Direct your comments to Docket ID No. TRI-2005-0004. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.epa.gov/edocket, 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 EDOCKET, regulations.gov, or e-mail. The EPA EDOCKET and the Federal regulations.gov Web sites are “anonymous access” systems, 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 EDOCKET or regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public 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 EDOCKET index at: http://www.epa.gov/edocket. Although listed in the index, some information is not publicly available, i.e., 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 electronically in EDOCKET or in hard copy at the OEI Docket, EPA/DC, EPA West, Room B102, 1301 Constitution Ave., NW., Washington, DC. 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 OEI Docket is 202-566-1752.

          FOR FURTHER INFORMATION CONTACT:

          Daniel R. Bushman, Toxics Release Inventory Program Division, Office of Information Analysis and Access (2844T), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 202-566-0743; fax number: 202-566-0741; e-mail: bushman.daniel@epamail.epa.gov, for specific information on this proposed rule, or for more information on EPCRA section 313, the Emergency Planning and Community Right-to-Know Hotline, Environmental Protection Agency, Mail Code 5101, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Toll free: 1-800-424-9346, in Virginia and Alaska: 703-412-9810 or Toll free TDD: 1-800-553-7672.

        SUPPLEMENTARY INFORMATION:
        I. General Information
        A. Does This Notice Apply To Me?

        You may be potentially affected by this notice if you manufacture, process, or otherwise use DINP. Potentially affected categories and entities may include, but are not limited to:

            Category
            Examples of potentially affected entities

            Industry

            SIC major group codes 10 (except 1011, 1081, and 1094); 12 (except 1241); or 20 through 39; or industry codes 4911 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce); or 4931 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce); or 4939 (limited to facilities that combust coal and/or oil for the purpose of generating power for distribution in commerce); or 4953 (limited to facilities regulated under the Resource Conservation and Recovery Act, subtitle C, 42 U.S.C. section 6921 et seq.); or 5169; or 5171; or 7389 (limited to facilities primarily engaged in solvent recovery services on a contract or fee basis).

            Federal Government
            Federal facilities.

        This table 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 the table could also be affected. To determine whether your facility would be affected by this action, you should carefully examine the applicability criteria in part 372 subpart B of Title 40 of the Code of Federal Regulations. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding FOR FURTHER INFORMATION CONTACT section.
        B. How Should I Submit CBI To the Agency?
        Do not submit information that you consider to be CBI electronically through EPA's electronic public docket or by e-mail. Commenters wishing to submit proprietary information for consideration must clearly distinguish such information from other comments and clearly label it as CBI. Send submissions containing such proprietary information directly to the following address only, and not to the public docket, to ensure that proprietary information is not inadvertently placed in the docket: Attention: OEI Document Control Officer, Mail Code: 2822T, U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC, 20460. You may claim information that you submit to EPA as CBI by marking any part or all of that information as CBI (if you submit CBI on disk or CD ROM, 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 CBI). The EPA will disclose information claimed as CBI only to the extent allowed by the procedures set forth in 40 CFR part 2.

        In addition to one complete version of the comment that includes any 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 and EPA's electronic public docket. If you submit the copy that does not contain CBI on disk or CD ROM, mark the outside of the disk or CD ROM clearly that it does not contain CBI. Information not marked as CBI will be included in the public docket and EPA's electronic public docket without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the FOR FURTHER INFORMATION CONTACT section.
        II. What Did EPA Propose and What Is the Purpose of This Notice?
        In response to a petition to add diisononyl phthalate (DINP) to the EPCRA section 313 list of toxic chemicals, EPA published a proposed rule to add a DINP category to the EPCRA section 313 list (65 FR 53681, September 5, 2000). The proposed rule was based on information contained in the hazard assessment for DINP that was developed in response to the petition (Ref. 1). In response to comments on the proposal, EPA revised its hazard assessment for DINP. The purpose of this notice is to allow the public an opportunity to comment on a revised hazard assessment that EPA has developed for DINP (Ref. 2).
        A. What Preliminary Determinations Did EPA Reach in the Proposed Rule?
        After a review of the data available at the time, the Agency preliminarily determined that there was sufficient evidence to support the conclusion that DINP can reasonably be anticipated to cause carcinogenicity and liver, kidney, and developmental toxicity. The preliminary findings were summarized as follows.

          DINP has been shown to cause developmental toxicity in prenatal rats. This developmental toxicity included significant decreases in the mean body weight of pups from two generations which may result in serious developmental delays in growth throughout the lifetime. In addition, skeletal variations were observed which may interfere with normal nerve function and blood flow. Kidney effects in fetuses were observed which might lead to progressive kidney damage and impaired kidney function.
          DINP has been shown to cause chronic liver and kidney toxicity in rats and mice. The liver effects are indicators of the serious liver damage produced by DINP and are early indicators of the tissue damage which leads to DINP-induced tumors. In addition to chronic liver toxicity, biochemical indicators of chronic kidney toxicity were evident in male and female rats. Also, chronic progressive irreversible kidney damage (nephropathy) occurred in female mice which lead to early mortality.
          DINP has been shown to be a liver carcinogen in rats and mice, to induce kidney tumors in male rats, and to increase the incidence of mononuclear cell leukemia. (65 FR 53686, September 5, 2000).

          EPA EAPA also stated that:

          EPA currently believes that it is reasonable to anticipate that all members of the DINP category as described will exhibit carcinogenicity and liver, kidney, and developmental toxicity in humans and that creating a category of DINP is the most appropriate way to list this class of chemicals. (65 FR 53686, September 5, 2000).

        B. Why Has EPA Issued This Notice?
        EPA received significant comments on its original hazard assessment for DINP both during the comment period for the proposed rule and in later submissions to the Agency. Based on the comments EPA received, the Agency decided to revise the DINP hazard assessment and subject the document to a peer review process. The revised DINP hazard assessment was reviewed by experts within EPA and then by a group of external peer reviewers. Based on these reviews EPA made additional revisions to the DINP hazard assessment. The comments received from the external peer reviewers and EPA's responses to those comments have been placed in the docket for this notice (Ref. 3). The revisions to the hazard assessment have an impact on the preliminary conclusions that EPA reached in the proposed rule. Therefore, EPA is making the revised DINP hazard assessment available for public comment through the publication of this notice.
        III. How Has the Hazard Assessment Changed?

        The original DINP hazard assessment has been updated to include the most recent data available on the toxicity of DINP and has been revised based on public comments and on feedback from internal and external peer reviewers. Based on public comment, the revised hazard assessment has been expanded to include a more extensive discussion of each human health endpoint of concern. The significant substantive changes to the hazard assessment are discussed in the following sections.
        A. What Changes Have Been Made to the Discussion of Carcinogenicity?
        1. Liver Cancer. In the original DINP hazard assessment (Ref. 1), EPA stated that DINP was a liver carcinogen in rats and mice and could reasonably be anticipated to cause cancer in humans. Liver tumors were demonstrated in three independent chronic studies in rats and mice (Refs. 4, 5, and 6). At that time, EPA acknowledged that there was an ongoing scientific discussion regarding the role of peroxisome proliferation and peroxisome proliferation activating receptor-÷ (PPAR÷) activation in rodent liver tumors and its relevance to human cancer.
        In accordance with EPA's cancer guidelines (Ref. 7), however, the data were considered insufficient to demonstrate that a response in animals was not relevant to any human situation. Therefore, the default assumption that positive effects in animal studies indicate that DINP could have carcinogenic potential in humans was warranted. Based on this default assumption, EPA's position in the original hazard assessment was that DINP could reasonably be anticipated to cause cancer in humans.
        Recently, the Office of Prevention, Pesticides and Toxics Substances (OPPTS) presented a draft of a proposed OPPTS science policy on PPARαmediated hepatocarcinogenicity to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Science Advisory Panel (SAP), a Federal advisory committee. The SAP serves as the primary scientific peer review mechanism of OPPTS under Section 25(d) of FIFRA. The guidance document described an approach OPPTS proposed to use to evaluate the scientific information regarding the mode of action of PPAR÷ activating chemicals, such as DINP, in rodent liver tumors and the relevance of this mode of action for human liver cancer. EPA is currently reviewing the responses from the FIFRA SAP and will notify the public on a science policy decision. EPA therefore reserves judgment on whether DINP can reasonably be anticipated to cause liver cancer in humans, pending the results of this EPA review. The revised DINP hazard assessment has been updated to include a discussion of EPA's ongoing review.
        2. Mononuclear Cell Leukemia. In the original DINP hazard assessment (Ref. 1), EPA stated that there were clear, statistically significant increases in the incidences of mononuclear cell leukemia (MNCL) in two independent chronic oral studies using Fischer rats. Fischer rats (F-344) had an increased mortality due to MNCL in DINP-treated rats suggesting that DINP is associated with the elevated incidence, progression and severity of MNCL. The tumor findings may be biologically significant because the time to onset of tumor was shorter and the disease was more severe in treated animals compared to the timing of onset and severity in control animals. EPA believes that it is therefore highly unlikely that these findings were unrelated to treatment. EPA notes, however, that there are several sources of uncertainty in the interpretation of the MNCL data. These include a high and variable background rate of MNCL and a lack of information on the mode of action for induction of MNCL. Furthermore, some scientists believe that MNCL may be a rodent-specific cancer of unclear relevance to human cancer. EPA is reviewing the scientific question of the biological relevance of MNCL and human cancer. As a result of these scientific uncertainties, EPA reserves judgment on the human significance of MNCL and whether DINP can reasonably be anticipated to cause cancer in humans.
        Because the data currently available do not permit a clear conclusion on the relevance of DINP-induced liver tumors and MNCL at this time, EPA reserves judgment on whether DINP can reasonably be anticipated to cause cancer in humans.
        B. What Changes Have Been Made to the Discussion of Chronic Liver Toxicity?

        In the original DINP hazard assessment (Ref. 1), EPA stated that DINP could reasonably be anticipated to cause chronic liver toxicity based on increased liver weight, increased liver enzyme activities, and chronic liver lesions based on two chronic studies in rats (Refs. 4 and 5). In the revised hazard assessment, the chronic liver lesion is described in more detail and identified as spongiosis hepatis. The incidence of spongiosis hepatis was dose-related and significantly elevated in male rats chronically treated with DINP in two independent studies conducted by different laboratories. The incidence of spongiosis hepatis was not elevated in female rats or in male or female mice. Based on the available data, the Agency has identified a No Observed Adverse Effect Level (NOAEL) of 15 milligrams per kilogram per day (mg/kg/day) and a Lowest Observed Adverse Effect Level (LOAEL) of 152 mg/kg/day for the Lington et al. study (Ref. 4) and a NOAEL of 88 mg/kg/day and a LOAEL of 359 mg/kg/day for the Moore study (Ref. 5), based on indications of serious liver damage (i.e., a statistically significant increased incidence of spongiosis hepatis and increased liver weight and liver enzyme activities) in male rats chronically exposed to DINP for two years.
        The Agency believes that the existing data support the conclusion that the increased incidence of spongiosis hepatis in dosed rats is clearly related to DINP treatment. In further evaluating the data for hepatic spongiosis, the Agency considered (1) The possibility that the occurrence of spongiosis hepatis and induction of peroxisome proliferation were related; (2) the possibility that the occurrence of spongiosis hepatis was a consequence of MNCL; (3) the relationship of spongiosis hepatis to hepatocellular cancer; and (4) the human relevance of hepatis spongiosis.

        EPA believes that the occurrence of spongiosis hepatis is not likely to be related to the occurrence of peroxisome proliferation, hepatocellular cancer, or MNCL. Spongiosis hepatis is a lesion of the perisinusoidal cells of the liver (the Ito cells) whereas the carcinogenic and other toxic effects of DINP on the liver involved hepatocytes, which are the predominant cell type in the liver. This lesion has been found in livers of rodents and fish following exposure to substances (e.g., nitrosamines) that induce cancer in these species (Ref. 8). Both chronic studies of DINP (Refs. 4 and 5) reported increased incidences of treated male rats with spongiosis hepatis. EPA has determined that spongiosis hepatis is relevant to human health and that determination is discussed in detail in the revised hazard assessment (Ref. 2, section II.E.1).

        Spongiosis hepatis was also considered to be a significant finding by the authoritative scientific panel, the U.S. Consumer Product Safety Commission's (CPSC) Chronic Hazard Advisory Panel (CHAP) on DINP in their final report (Ref. 9). In addition to the CPSC panel report, a Histopathology Peer Review and Pathology Working Group convened by Experimental Pathology Laboratories (ELP) (Ref. 10) independently evaluated the liver slides from rats chronically treated with DINP and confirmed that the spongiosis hepatitis was increased in male rats of both chronic rodent studies. These findings support EPA's position that chronic liver toxicity is an endpoint of concern for DINP. At the time of the development of the original DINP hazard assessment, EPA had not reviewed the ELP report (Ref. 10), or seen the CHAP report (Ref. 9) that discusses the ELP report conclusions because the final CHAP report was not available.
        IV. How Does the Revised Hazard Assessment Impact EPA's Previous Conclusions About the Toxicity of DINP?
        In the previous DINP hazard assessment (Ref. 1), carcinogenicity was determined to be a significant concern for DINP. However, based on the revised hazard assessment (Ref. 2), at this time EPA reserves judgment on whether cancer is an endpoint of concern for DINP. This conclusion may change in the future depending on how EPA resolves the issues concerning the human relevance of the types of tumors that DINP has been shown to cause. The revised hazard assessment also provides a more detailed and specific discussion about the ability of DINP to cause chronic liver toxicity than that contained in the previous hazard assessment. The revised discussion on chronic liver toxicity provides additional support to the previous conclusion that DINP causes chronic liver toxicity.
        The revised DINP hazard assessment does not affect the previous conclusions from the original DINP hazard assessment that developmental and chronic kidney toxicity are endpoints of concern for DINP. In addition, nothing in the revised DINP hazard assessment affects EPA's previous conclusion that the addition of DINP as a category of chemicals, rather than individual chemical listings, would be appropriate.
        V. What Type of Comments Is EPA Interested In Receiving?
        EPA is requesting comments on all parts of the revised hazard assessment. However, EPA is specifically interested in comments on the sections of the revised hazard assessment that deal with carcinogenicity and chronic liver toxicity. EPA also requests commenters to provide any additional data or information on the human relevance of any of the adverse effects discussed in the revised hazard assessment.
        VI. References

        EPA has established an official public docket for this action under Docket ID No. TRI-2005-0004. The previous docket number for the proposed rule was OEI-100004 and was assigned prior to the development of EPA's electronic public docket and comment system. Therefore, EPA is creating a new electronic docket number for this action. All the materials submitted to docket number OEI-100004 have been transferred to docket number TRI-2005-0004. The public docket includes information considered by EPA in developing this proposed rule, including the documents listed below, which are electronically or physically located in the docket. In addition, interested parties should consult documents that are referenced in the documents that EPA has placed in the docket, regardless of whether these referenced documents are electronically or physically located in the docket. For assistance in locating documents that are referenced in documents that EPA has placed in the docket, but that are not electronically or physically located in the docket, please consult the person listed in the above FOR FURTHER INFORMATION CONTACT section.
        1. USEPA, OEI. 2000. Technical Review of Diisononyl Phthalate. Office of Environmental Information, Becki Madison, Christine Augustyniak, Ron Bloom, Candace Brassard, Ossi Meyn, Nicole Paquette, Pam Russell, and John Scalera.
        2. USEPA, OEI. 2005. Revised Technical Review of Diisononyl Phthalate, March 4, 2005. Office of Environmental Information, Environmental Analysis Division, Analytical Support Branch. Amy Newman, Candace Brassard, Kathryn Montague, Nicole Paquette, Ph.D., and John Scalera.
        3. USEPA, OEI. 2005. Response to External Peer Review Comments on the Revised Technical Review for Diisononyl Phthalate, April 2005.
        4. Lington, A.W.; Bird M.G.; Plutnick, R.T.; Stubblefield, W.A.; and Scala, RA. 1997. Chronic toxicity and carcinogenic evaluation of diisononyl phthalate in rats. Fundam. Appl. Toxicol 36: 79-89.
        5. Moore, M.R., 1998. Oncogenicity study in rats with di(isononyl)phthalate including ancillary hepatocellular proliferation and biochemical analyses. TSCATS Doc# 89980000308. Old Doc 8EHQ099813083. Fiche # OTS05562832. Submitted by Aristech Chemical Corporation. Produced by Covance Laboratories 2598-104.
        6. Moore M.R., 1998. Oncogenicity study in mice with di(isononyl)phthalate including ancillary hepatocellular proliferation and biochemical analyses. TSCATS Doc# 89990000046. Old Doc 8EHQ119813083. Fiche # OTS05562833. Submitted by Aristech Chemical Corp. Produced by Covance 2598-105.
        7. USEPA. 1999. Draft Revised Guidelines for Carcinogen Risk Assessment. NCEA-F-0644, July 1999.
        8. Stoebel, P.; Mayer, F.; Zerban, H., Bannasch, P. 1995. Spongiotic pericytoma: a benign neoplasm deriving from the perisinusoidal cells in rat liver. Am. J. Pathol. 146:903-913.
        9. Chronic Hazard Advisory Panel on Diisononyl Phthalate. Report to the U.S. Consumer Product Safety Commission. June 2001. U.S. Consumer Product Safety Commission, Bethesda, MD.
        10. Experimental Pathology Laboratories, 1999. Histology peer review and pathology working group review of selected lesions of the liver and spleen in male and female F344 rats exposed to DINP. EPL Project number 303-013, Pathology Report.

          List of Subjects in 40 CFR Part 372
          Environmental protection, Chemicals, Community right-to-know, Hazardous substances, Intergovernmental relations, Reporting and recordkeeping requirements, Superfund.

          Dated: June 7, 2005.
          Kimberly T. Nelson,
          Assistant Administrator for Office of Environmental Information and Chief Information Officer.

      [FR Doc. 05-11664 Filed 6-13-05; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF THE INTERIOR
        Fish and Wildlife Service
        50 CFR Part 17
        [FWS-R8-ES-2007-0007; 92210-1117-0000-B4]
        RIN 1018-AU86
        Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for Acanthomintha ilicifolia (San Diego thornmint)

          AGENCY:
          Fish and Wildlife Service, Interior.

          ACTION:
          Proposed rule; reopening of public comment period and revisions to proposed critical habitat boundaries.

          SUMMARY:

          We, the U.S. Fish and Wildlife Service (Service), announce the reopening of the comment period on the proposed designation of critical habitat for Acanthomintha ilicifolia (San Diego thornmint) under the Endangered Species Act of 1973, as amended (Act). We are reopening the comment period because of new information we received following the close of the last public comment period on this proposed action. This new information leads us to propose revised boundaries for Subunit 1A and to update the areas we are proposing for exclusion from the final designation. The reopened comment period will provide the public; Federal, State, and local agencies; and Tribes with an additional opportunity to submit comments on the original proposed rule and the revisions proposed in this document. Comments previously submitted on the proposed critical habitat designation for A. ilicifolia need not be resubmitted as they have already been incorporated into the public record and will be fully considered in any final decision.

          DATES:
          We will consider comments and information received or postmarked on or before June 12, 2008.

          ADDRESSES:
          You may submit comments by one of the following methods:
          • Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
          • U.S. mail or hand-delivery: Public Comments Processing, Attn: RIN 1018-AU86; Division of Policy and Directives Management; U.S. Fish and Wildlife Service; 4401 N. Fairfax Drive, Suite 222; Arlington, VA 22203.

          We will not accept e-mail or faxes. 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:
          Jim Bartel, Field Supervisor, U.S. Fish and Wildlife Service, Carlsbad Fish and Wildlife Office, 6010 Hidden Valley Road, Carlsbad, CA 92011; telephone 760-431-9440; facsimile 760-431-5901. If you use a telecommunications device for the deaf (TDD), call the Federal Information Relay Service (FIRS) at 800-877-8339.

        SUPPLEMENTARY INFORMATION:
        Public Comments

        We will accept written comments and information during this reopened comment period on our proposed critical habitat designation for Acanthomintha ilicifolia published in the Federal Register on March 14, 2007 (72 FR 11945), the corrections to the proposed designation published in the Federal Register on November 27, 2007 (72 FR 66122), and the new information provided in this document. We will consider information and recommendations from all interested parties. We are particularly interested in comments concerning:

        (1) The reasons why we should or should not designate habitat as critical habitat under section 4 of the Act (16 U.S.C. 1531 et seq.), including whether the benefit of designation would outweigh threats to the species caused by the designation, such that the designation of critical habitat is prudent.
        (2) Specific information on:
        • The amount and distribution of Acanthomintha ilicifolia habitat,
        • What areas within the geographical area occupied at the time of listing that contain features essential for the conservation of the species we should include in the designation and why, and
        • What areas not occupied at the time of listing are essential to the conservation of the species and why.

        (3) Any proposed critical habitat areas covered by conservation or management plans that we should consider for exclusion from the designation under section 4(b)(2) of the Act. We specifically request information on any operative or draft habitat conservation plans that include Acanthomintha ilicifolia as a covered species that have been prepared under section 10(a)(1)(B) of the Act, or any other management plan, conservation plan, or agreement that benefits the species or its physical and biological features.
        (4) Land use designations and current or planned activities in the proposed critical habitat areas and their possible impacts on proposed critical habitat for the species.
        (5) Specific information concerning whether the benefits of excluding areas proposed for critical habitat within the City of San Diego subarea plan and the County of San Diego subarea plan under the San Diego Multiple Species Conservation Program (MSCP), the Carlsbad and Encinitas subarea plans under the San Diego Multiple Habitat Conservation Program (MHCP), and the Manchester Avenue Mitigation Bank under section 4(b)(2) of the Act outweigh the benefits of their inclusion in designated critical habitat.
        (6) Additional scientific or commercial information that will help us to better delineate areas that contain the primary constituent elements laid out in the appropriate quantity and spatial arrangement essential for the conservation of the species, specifically, information pertaining to the amount and distribution of the primary constituent elements in Subunit 1A.
        (7) Information about potential impacts that the designation of critical habitat in Subunit 1A may have on the operation of McClellan-Palomar Airport, specifically, whether the benefits of excluding this area would outweigh the benefits of including this area under section 4(b)(2) of the Act.
        (8) Any foreseeable economic, national security, or other relevant impacts resulting from the proposed designation and, in particular, any impacts on small entities.
        (9) Whether we could improve or modify our approach to designating critical habitat in any way to provide for greater public participation and understanding, or to better accommodate public concerns and comments.
        Comments and information submitted on the proposed rule (72 FR 11945) during the initial comment period from March 14, 2007, to May 14, 2007, or the second comment period (72 FR 66122) from November 27, 2007, to December 27, 2007, do not need to be resubmitted as they have already been incorporated into the public record. Our final determination concerning the designation of critical habitat will take into consideration all written comments and any additional information we receive during all comment periods. On the basis of information provided during the public comment periods on the critical habitat proposal and the associated draft economic analysis (DEA), we may, during the development of our final determination, find that areas proposed do not meet the definition of “critical habitat” under section 3(5)(A) of the Act, or are appropriate for exclusion under section 4(b)(2) of the Act.

        You may submit your comments and materials concerning our proposed rule by one of the methods listed in the ADDRESSES section. We will not consider comments sent by e-mail or fax or to an address not listed in the ADDRESSES section.
        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. 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. We will post all hardcopy comments on http://www.regulations.gov.

        Comments and materials we receive, as well as supporting documentation we used in preparing this notice, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Carlsbad Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT).

        You may obtain copies of the proposed rule and DEA by mail from the Carlsbad Fish and Wildlife Office (see FOR FURTHER INFORMATION CONTACT) or by visiting the Federal eRulemaking Portal at http://www.regulations.gov.

        Background

        It is our intent to discuss only those topics directly relevant to the designation of critical habitat in this notice. For more information on the taxonomy and biology of Acanthomintha ilicifolia, refer to the final listing rule published in the Federal Register on October 13, 1998 (63 FR 54938) and the proposed critical habitat rule published on March 14, 2007 (72 FR 11945).

        On August 10, 2004, the Center for Biological Diversity and California Native Plant Society challenged our failure to designate critical habitat for Acanthomintha ilicifolia as well as four other plant species (Center for Biological Diversity, et al. v. Norton, C-04-3240 JL (N. D. Cal.)). In settlement of the lawsuit, the Service agreed to submit to the Federal Register a proposed rule to designate critical habitat, if prudent, on or before February 28, 2007, and a final designation by February 28, 2008. On March 14, 2007, we published a proposed rule to designate critical habitat for A. ilicifolia (72 FR 11945), identifying a total of approximately 1,936 acres (ac) (783 hectares (ha)) of land in San Diego County, California. We proposed 1,302 ac (527 ha) of land for exclusion from the final designation of critical habitat under section 4(b)(2) of the Act. On November 27, 2007, we reopened the comment period on the proposed rule, announced the availability of the draft economic analysis for the proposed rule, and made several corrections to the proposed rule (72 FR 66122). As a result of the corrections, the proposed critical habitat (1,936 acres (ac) (783 hectares (ha))) was reduced by approximately 69 ac (27 ha) and the area being proposed for exclusion (1,302 ac (527 ha)) was reduced by 168 ac (68 ha). Therefore, the total amount of land proposed as critical habitat was 1,867 ac (756 ha). Of the total amount of land proposed as critical habitat, we proposed to exclude 1,134 ac (459 ha) from the final designation. Due to the substantive nature of the comments and new information received on this proposed rule, we requested an extension of the February 28, 2008, court-ordered date for the completion of the final designation. An extension was granted on April 15, 2008, which now requires us to submit to the Federal Register the final critical habitat designation by August 14, 2008.
        Section 3 of the Act defines critical habitat as the specific areas within the geographical area occupied by a species, at the time it is listed in accordance with the Act, on which are found those physical or biological features essential to the conservation of the species and that may require special management considerations or protection, and specific areas outside the geographical area occupied by a species at the time it is listed, upon a determination that such areas are essential for the conservation of the species. If the proposed rule is made final, section 7 of the Act will prohibit destruction or adverse modification of critical habitat by any activity funded, authorized, or carried out by any Federal agency. Federal agencies proposing actions affecting areas designated as critical habitat must consult with us on the effects of their proposed actions, pursuant to section 7(a)(2) of the Act.
        New Information Relating to the Proposed Critical Habitat, Revisions to Proposed Critical Habitat Boundaries, and Updated Areas Proposed for Exclusion

        On March 14, 2007, we proposed to designate critical habitat in four units comprising a total of 1,936 ac (783 ha) (72 FR 11945). At that time we proposed to exclude 1,302 ac (527 ha) under section 4(b)(2) of the Act (72 FR 11945, March 14, 2007). In the notice of availability for the draft economic analysis (DEA) published on November 27, 2007 (72 FR 66122), we announced corrections to the proposed designation that reduced the size of several subunits. As a result of those corrections, the total identified proposed critical habitat area was reduced from 1,936 ac (783 ha) to 1,867 ac (756 ha). Of the total amount of land proposed as critical habitat, the total area proposed for exclusion from the final designation was reduced from 1,302 ac (527 ha) to 1,134 ac (459 ha). Following publication of the November 27, 2007, document, we received new information for Subunit 1A that leads us to reduce the proposed critical habitat by an additional 17 ac (7 ha). Therefore, at this time we are proposing a total of 1,850 ac (749 ha) as critical habitat for Acanthomintha ilicifolia. Additionally, we have become aware of information indicating that excluding Subunits 1A, 1B, and 1C within the MHCP may not be appropriate. Of the 1,850 ac (749 ha) we are proposing as critical habitat, we are intending to exclude 964 ac (390 ha) from the final designation. The information we received that led to these intended changes is presented below. We are opening this comment period to provide the public the opportunity to comment on these items.

        We received two comments indicating some areas in Subunit 1A are developed as agricultural land and some areas are actively used for maintenance and navigation purposes for McClellan-Palomar Airport. Further, the Federal Aviation Administration (FAA) requested the Service to consider impacts associated with the designation of critical habitat in Subunit 1A (Palomar Airport) on the operation of McClellan-Palomar Airport. Specifically, the FAA requested that we not designate critical habitat in areas of Subunit 1A that encompass a series of navigational devices (i.e., Medium Intensity Approach Lighting System with Runway Alignment Indicator Lights (MALSRs)) and an associated dirt maintenance road. We met with the County of San Diego and the FAA at Subunit 1A on January 9, 2008, and we mapped agricultural fields and areas that are actively used for maintenance and navigation purposes at McClellan-Palomar Airport. We found that portions of the agricultural fields immediately adjacent to known occurrences of Acanthomintha ilicifolia do contain the primary constituent element (PCE) (PCE subparts 1b and 1c; clay lenses on gently sloping terrain and derived from gabbro and soft calcareous sandstone substrates) laid out in the appropriate quantity and spatial arrangement for the conservation of the species and contribute to the stability and function of the habitat in Subunit 1A. However, the developed agricultural areas farther than approximately 100 feet (ft) (30 meters (m)) from known occurrences of A. ilicifolia, and the entirety of the dirt maintenance road within Subunit 1A, no longer appear to contain the features essential to the conservation of A. ilicifolia. While the agricultural fields have the same clay soil that supports A. ilicifolia, these areas no longer support the species because the soil structure has been altered by discing and other agricultural practices, and the soil no longer has the crumbly texture and deep fissures that are indicative of this species' habitat (PCE subpart 1c). Additionally, the area is infested with nonnative plants, and open areas no longer exist to support A. ilicifolia (PCE subpart 1d). We have determined that the developed areas of Subunit 1A have been altered to a point where these areas no longer contain the features essential for the conservation of A. ilicifolia. Therefore, the developed areas in Subunit 1A greater than 100 ft (30 m) from known occurrences of A. ilicifolia and the entirety of the dirt maintenance road do not meet the definition of critical habitat. A total of 17 ac (7 ha) have been removed from the area proposed as Subunit 1A; the resulting area now identified as critical habitat in this unit is 71 ac (29 ha). As noted above, we are requesting additional information from the public pertaining to the proposed designation of critical habitat encompassing the MALSRs and whether the benefits of excluding this area would outweigh the benefits of including this area under section 4(b)(2) of the Act.

        In the March 14, 2007, proposed rule (72 FR 11945), we proposed the exclusion of and requested public comment on lands in Subunits 1A and 1B covered by the Carlsbad Habitat Management Plan (HMP; i.e., the Carlsbad Subarea Plan) under the MHCP from the designation of critical habitat under section 4(b)(2) of the Act. Upon further analysis of the Carlsbad HMP, we found that coverage of Acanthomintha ilicifolia under this habitat conservation plan (HCP) is contingent on a funded management plan being in place for this species and the completion of the San Marcos subarea plan under the MHCP. In the time that has elapsed since the development and publication of the proposed rule (March 14, 2007, 72 FR 11945), the City of San Marcos has not completed its subarea plan. Therefore, we believe that excluding land covered by the Carlsbad HMP in Subunits 1A and 1B is inappropriate. With the information we have at this time, we intend to designate the lands covered by the Carlsbad HMP in Subunits 1A and 1B as critical habitat. While we have received one comment indicating that some land in Subunit 1A is conserved and managed, we do not believe this meets the requirements for A. ilicifolia to be covered under the Carlsbad HMP. We are requesting additional information from the public on the appropriateness of excluding lands covered by the Carlsbad HMP.

        In the March 14, 2007, proposed rule (72 FR 11945), we proposed the exclusion of, and requested public comment on, the lands in Subunit 1C covered by the pending Encinitas subarea plan under the MHCP from the designation of critical habitat under section 4(b)(2) of the Act. At this time, the Encinitas subarea plan has not been completed and we believe excluding land based solely on its inclusion within the boundaries of this incomplete subarea plan would be inappropriate. Conversely, the majority of Subunit 1C (72 ac (29 ha)) is part of the Manchester Avenue Mitigation Bank and is actively managed for Acanthomintha ilicifolia (Spiegelberg 2005, pp. 1-33). We believe the benefits of exclusion may outweigh the benefits of including these lands in a critical habitat designation and that this exclusion would not result in extinction of the species. Therefore, we are considering the possibility of excluding 72 ac (29 ha) of Subunit 1C under section 4(b)(2) of the Act and designating the remaining 20 ac (8 ha) of private lands outside the Manchester Avenue Mitigation Bank as critical habitat. We are requesting public comment on benefits of including and benefits of excluding lands from critical habitat designation that are: (1) Covered by the Manchester Avenue Mitigation Bank; and (2) outside of the Manchester Avenue Mitigation Bank, but within the pending Encinitas subarea plan.

        We hereby notify the public that the final designation of critical habitat may differ from the proposed rule published on March 14, 2007 (72 FR 11945), as corrected on November 27, 2007 (72 FR 66122). We intend to use the best available scientific and commercial data available to delineate the specific geographic areas that contain the physical and biological features essential to the conservation of Acanthomintha ilicifolia (i.e., the PCE laid out in the appropriate quantity and spatial arrangement) or that are otherwise essential for the conservation of the species and in making decisions regarding exclusions under 4(b)(2) of the Act. Therefore, we are requesting any additional information that may be useful in reassessing the proposed boundaries of critical habitat. Additionally, we request any information that may be useful in determining whether or not the benefits of excluding areas from critical habitat under section 4(b)(2) of the Act outweigh the benefits of including areas in critical habitat, specifically regarding the exclusion of areas covered by the MHCP as discussed in the proposed rule (72 FR 11945, March 14, 2007) (i.e., the areas within the cities of Carlsbad and Encinitas, California), considering the new information summarized above. Additional comments and information on these issues will help make the final rule as accurate as possible.

        Table 1 contains the corrected area values based on revisions to proposed critical habitat Subunits 1A and 1C. The revisions to Subunit 1A change the boundary description published in the March 14, 2007, proposed rule. This document publishes the boundary description for Subunit 1A, incorporating the revisions described in this document, along with a map depicting the revised location of proposed critical habitat for Acanthomintha ilicifolia.

          Table 1.—Areas Proposed as Critical Habitat for Acanthomintha ilicifolia After the Corrections and Amendments to the Areas Proposed as Critical Habitat on March 14, 2007 (72 FR 11945), as Described in This Document and the Document Published on November 27, 2007 (72 FR 66122), and Areas Being Proposed and Considered for Exclusion From the Final Critical Habitat Designation Under Section 4(b)(2) of the Act (Acres (ac), Hectares (ha), CNDDB Element Occurrences (EO))

            Critical habitat unit
            Land ownership
            Area proposed as critical habitat in March 14, 2007, proposed rule
            Area proposed as critical habitat after corrections and amendments
            Area proposed for exclusion from final critical habitat
            Area being considered for exclusion from final critical habitat

              Unit 1: Northern San Diego County

            1A. Palomar Airport (EO 70)
            Private
            7 ac (3 ha)
            7 ac (3 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            State/Local
            81 ac (33 ha)
            64 ac (26 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            1B. Southeast Carlsbad (EO 47)
            Private
            73 ac (29 ha)
            73 ac (29 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            1C. Manchester (EO 28, EO 42 and EO 54)
            Private
            92 ac (37 ha)
            92 ac (37 ha)
            0 ac (0 ha)
            72 ac (29 ha).

              Unit 2: Central San Diego County

            2A. Los Peñasquitos Canyon (EO 19)
            State/Local
            63 ac (25 ha)
            63 ac (25 ha)
            63 ac (25 ha)
            0 ac (0 ha).

            2B. Sabre Springs (EO 36)
            Private
            1 ac (<1 ha)
            1 ac (<1 ha)
            1 ac (<1 ha)
            0 ac (0 ha).

            State/Local
            51 ac (21 ha)
            51 ac (21 ha)
            51 ac (21 ha)
            0 ac (0 ha).

            2C. Sycamore Canyon (EO 32)
            Private
            30 ac (12 ha)
            30 ac (12 ha)
            30 ac (12 ha)
            0 ac (0 ha).

            State/Local
            276 ac (112 ha)
            276 ac (112 ha)
            276 ac (112 ha)
            0 ac (0 ha).

            2D. Slaughterhouse Canyon (EO 64)
            Private
            77 ac (31 ha)
            77 ac (31 ha)
            77 ac (31 ha)
            0 ac (0 ha).

              Unit 3: Viejas Mountain and Poser Mountain

            3A. Viejas Mountain (EO 73)
            Private
            33 ac (13 ha)
            33 ac (13 ha)
            33 ac (13 ha)
            0 ac (0 ha).

            3B. Viejas Mountain (EO 50)
            Private
            156 ac (63 ha)
            156 ac (63 ha)
            156 ac (63 ha)
            0 ac (0 ha).

            Federal
            52 ac (21 ha)
            52 ac (21 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            3C. Viejas Mountain (EO 51)
            Private
            38 ac (15 ha)
            38 ac (15 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            Federal
            280 ac (113 ha)
            280 ac (113 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            3D. Viejas Mountain (EO 62)
            Private
            50 ac (20 ha)
            50 ac (20 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            Federal
            32 ac (13 ha)
            32 ac (13 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            3E. Poser Mountain (EO 74)
            Federal
            34 ac (14 ha)
            34 ac (14 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            3F. Poser Mountain (EO 12)
            Private
            7 ac (3 ha)
            7 ac (3 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            Federal
            156 ac (63 ha)
            156 ac (63 ha)
            0 ac (0 ha)
            0 ac (0 ha).

              Unit 4: Southern San Diego County

            4A. McGinty Mountain (EO 21)
            Private
            18 ac (7 ha)
            18 ac (7 ha)
            18 ac (7 ha)
            0 ac (0 ha).

            Federal
            0 ac (0 ha)
            2 ac (1 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            4B. McGinty Mountain (EO 22)
            Private
            210 ac (85 ha)
            141 ac (57 ha)
            141 ac (57 ha)
            0 ac (0 ha).

            State/Local
            10 ac (4 ha)
            7 ac (3 ha)
            7 ac (3 ha)
            0 ac (0 ha).

            4C. McGinty Mountain (EO 30)
            Private
            27 ac (11 ha)
            27 ac (11 ha)
            27 ac (11 ha)
            0 ac (0 ha).

            Federal
            0 ac (0 ha)
            1 ac (<1 ha)
            0 ac (0 ha)
            0 ac (0 ha).

            4D. Hollenbeck Canyon (EO L)
            Private
            23 ac (9 ha)
            23 ac (9 ha)
            23 ac (9 ha)
            0 ac (0 ha).

            State/Local
            61 ac (25 ha)
            61 ac (25 ha)
            61 ac (25 ha)
            0 ac (0 ha).

            Total *

            1,936 ac (783 ha)
            1,850 ac (749 ha)
            964 ac (390 ha)
            72 ac (429 ha).

          * Some columns may not sum exactly due to rounding of values.

        Below, we present brief descriptions of the revised proposed subunits and reasons why they meet the definition of critical habitat for Acanthomintha ilicifolia. These revised subunit descriptions replace those provided in the March 14, 2007, proposed rule (72 FR 11945). California Natural Diversity Database (CNDDB) element occurrences are identified as EO in the subunit descriptions below.
        Unit Descriptions
        Subunit 1A, Palomar Airport (EO 70)
        Subunit 1A was occupied by Acanthomintha ilicifolia at the time of listing. Subunit 1A contains several habitat patches known to support A. ilicifolia and contains the features essential for the conservation of the species. Subunit 1A is located in Carlsbad, California, northeast of the intersection of Palomar Airport Road and El Camino Real. Subunit 1A consists of 64 ac (26 ha) of land owned by the County of San Diego and 7 ac (3 ha) of private land. Subunit 1A meets our selection criteria because it supports a population on a unique soil type (criterion 1). This is the only area where A. ilicifolia is still known to occupy calcareous clay soils. The features essential to the conservation of the species may require special management considerations or protection in this subunit to address threats from exotic plant species and unauthorized recreational activities.
        Subunit 1C, Manchester (EO 42, EO 28, and EO 54)
        Subunit 1C was occupied by Acanthomintha ilicifolia at the time of listing. Subunit 1C contains several habitat patches known to support A. ilicifolia and contains the features essential for the conservation of the species. Subunit 1C is located in Encinitas, California, northeast of the intersection of Manchester Avenue and South El Camino Real. Subunit 1C consists of 92 ac (37 ha) of private land. Subunit 1C meets our selection criteria because it supports one of the most stable populations of A. ilicifolia (criterion 3). The features essential to the conservation of the species may require special management considerations or protection in this subunit to address threats from exotic plant species and unauthorized recreational activities.

        The majority of the land that meets the definition of critical habitat in this area (72 ac (29 ha)) is in the Manchester Avenue Mitigation Bank. The Manchester Avenue Mitigation Bank is owned and managed by the Center for Natural Lands Management (CNLM). There is long-term management in place on this site to conserve several sensitive species, including Acanthomintha ilicifolia (Spiegelberg 2005, p. 1). The Manchester Avenue Mitigation Bank is covered by the Manchester Habitat Conservation Area Management Plan (Spiegelberg 2005). This plan provides for the management and monitoring of the portion of Subunit 1C owned by CNLM. Additionally, there is funding in place to provide for the long-term management of this area in a manner that will conserve A. ilicifolia. Therefore, we are considering the possibility of excluding 72 ac (29 ha) of Subunit 1C under section 4(b)(2) of the Act and soliciting public comment based on this consideration (see “Public Comments” section).
        References Cited

        A complete list of all references we cite in the proposed rule and this document is available on http://www.regulations.gov.

        Author
        The primary author of this notice is the staff of the Carlsbad Fish and Wildlife Office.

          List of Subjects in 50 CFR Part 17
          Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

        Proposed Regulation Promulgation
        Accordingly, we propose to further amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as proposed to be amended at 72 FR 11945, March 14, 2007, as set forth below:

          PART 17—[AMENDED]
          1. The authority citation for part 17 continues to read as follows:

            Authority:
            16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; Pub. L. 99-625, 100 Stat. 3500; unless otherwise noted.

          2. Critical habitat for Acanthomintha ilicifolia (San Diego thornmint) in § 17.96(a), which was proposed to be added on March 14, 2007, at 72 FR 11945, is proposed to be amended by revising paragraph (6)(i) and by revising paragraph (6)(iv), as follows:

            § 17.96
            Critical habitat—plants.
            (a) Flowering plants.

            Family Lamiaceae: Acanthomintha ilicifolia (San Diego thornmint)

            (6) * * *
            (i) Subunit 1A. Land bounded by the following UTM NAD27 coordinates (E,N): 475760, 3666013; 475747, 3665994; 475724, 3665985; 475692, 3665974; 475699, 3665944; 475697, 3665944; 475678, 3665937; 475677, 3665937; 475667, 3665934; 475657, 3665931; 475655, 3665931; 475629, 3665949; 475547, 3665912; 475552, 3665862; 475586, 3665824; 475639, 3665823; 475697, 3665853; 475706, 3665850; 475706, 3665850; 475707, 3665847; 475709, 3665845; 475710, 3665842; 475711, 3665840; 475713, 3665837; 475714, 3665834; 475715, 3665832; 475716, 3665829; 475717, 3665826; 475718, 3665823; 475719, 3665821; 475720, 3665818; 475721, 3665815; 475721, 3665812; 475722, 3665809; 475723, 3665807; 475723, 3665804; 475724, 3665801; 475724, 3665798; 475725, 3665795; 475725, 3665792; 475726, 3665789; 475726, 3665787; 475726, 3665784; 475726, 3665781; 475726, 3665778; 475726, 3665775; 475726, 3665772; 475726, 3665769; 475726, 3665766; 475726, 3665763; 475726, 3665760; 475726, 3665758; 475725, 3665755; 475725, 3665752; 475725, 3665751; 475690, 3665758; 475660, 3665748; 475563, 3665702; 475501, 3665704; 475399, 3665720; 475354, 3665731; 475352, 3665670; 475356, 3665635; 475364, 3665617; 475351, 3665612; 475329, 3665607; 475298, 3665608; 475276, 3665597; 475267, 3665596; 475257, 3665597; 475244, 3665599; 475234, 3665595; 475221, 3665587; 475164, 3665590; 475133, 3665640; 475096, 3665684; 475097, 3665687; 475098, 3665697; 475100, 3665707; 475103, 3665716; 475107, 3665725; 475111, 3665735; 475114, 3665741; 475123, 3665756; 475124, 3665759; 475129, 3665767; 475135, 3665775; 475142, 3665783; 475148, 3665790; 475156, 3665797; 475161, 3665801; 475175, 3665813; 475178, 3665815; 475186, 3665821; 475195, 3665826; 475203, 3665831; 475212, 3665835; 475215, 3665836; 475216, 3665844; 475216, 3665854; 475218, 3665864; 475220, 3665873; 475223, 3665883; 475227, 3665892; 475231, 3665901; 475236, 3665910; 475241, 3665919; 475247, 3665927; 475253, 3665934; 475260, 3665942; 475267, 3665948; 475286, 3665965; 475286, 3665965; 475294, 3665972; 475302, 3665977; 475310, 3665983; 475319, 3665987; 475328, 3665991; 475337, 3665995; 475338, 3665995; 475372, 3666006; 475381, 3666009; 475390, 3666011; 475400, 3666013; 475410, 3666014; 475420, 3666014; 475430, 3666014; 475440, 3666013; 475450, 3666011; 475452, 3666011; 475478, 3666005; 475474, 3666011; 475472, 3666014; 475466, 3666022; 475461, 3666030; 475456, 3666039; 475452, 3666048; 475448, 3666057; 475445, 3666067; 475443, 3666077; 475441, 3666087; 475440, 3666096; 475440, 3666106; 475440, 3666116; 475441, 3666126; 475443, 3666134; 475446, 3666150; 475446, 3666152; 475448, 3666162; 475451, 3666171; 475455, 3666181; 475459, 3666190; 475464, 3666199; 475468, 3666205; 475479, 3666223; 475480, 3666225; 475486, 3666233; 475492, 3666241; 475496, 3666245; 475511, 3666260; 475514, 3666263; 475518, 3666267; 475517, 3666269; 475517, 3666272; 475517, 3666275; 475516, 3666278; 475516, 3666281; 475516, 3666284; 475516, 3666287; 475516, 3666289; 475516, 3666292; 475516, 3666295; 475516, 3666298; 475517, 3666301; 475517, 3666304; 475517, 3666307; 475518, 3666310; 475518, 3666313; 475519, 3666315; 475519, 3666318; 475520, 3666321; 475520, 3666324; 475521, 3666327; 475522, 3666330; 475523, 3666332; 475524, 3666335; 475524, 3666338; 475525, 3666341; 475526, 3666343; 475528, 3666346; 475529, 3666349; 475530, 3666351; 475531, 3666354; 475532, 3666357; 475534, 3666359; 475535, 3666362; 475536, 3666364; 475538, 3666367; 475539, 3666369; 475541, 3666372; 475543, 3666374; 475544, 3666376; 475546, 3666379; 475548, 3666381; 475550, 3666383; 475551, 3666386; 475553, 3666388; 475555, 3666390; 475557, 3666392; 475559, 3666394; 475561, 3666396; 475563, 3666398; 475565, 3666400; 475568, 3666402; 475570, 3666404; 475572, 3666406; 475574, 3666408; 475577, 3666410; 475579, 3666411; 475581, 3666413; 475584, 3666415; 475586, 3666416; 475589, 3666418; 475591, 3666419; 475594, 3666421; 475596, 3666422; 475599, 3666424; 475601, 3666425; 475604, 3666426; 475607, 3666427; 475609, 3666428; 475612, 3666430; 475615, 3666431; 475617, 3666432; 475620, 3666433; 475623, 3666433; 475626, 3666434; 475628, 3666435; 475631, 3666436; 475634, 3666437; 475637, 3666437; 475640, 3666438; 475643, 3666438; 475645, 3666439; 475648, 3666439; 475651, 3666439; 475654, 3666440; 475657, 3666440; 475660, 3666440; 475663, 3666440; 475666, 3666440; 475669, 3666440; 475671, 3666440; 475674, 3666440; 475677, 3666440; 475680, 3666440; 475683, 3666440; 475686, 3666439; 475689, 3666439; 475692, 3666439; 475695, 3666438; 475697, 3666438; 475700, 3666437; 475703, 3666437; 475706, 3666436; 475709, 3666435; 475712, 3666434; 475714, 3666433; 475717, 3666433; 475717, 3666433; 475720, 3666432; 475723, 3666431; 475725, 3666430; 475728, 3666428; 475731, 3666427; 475733, 3666426; 475736, 3666425; 475738, 3666424; 475741, 3666422; 475744, 3666421; 475746, 3666419; 475749, 3666418; 475751, 3666416; 475753, 3666415; 475756, 3666413; 475758, 3666411; 475761, 3666410; 475763, 3666408; 475765, 3666406; 475767, 3666404; 475770, 3666402; 475772, 3666400; 475774, 3666398; 475776, 3666396; 475778, 3666394; 475780, 3666392; 475782, 3666390; 475784, 3666388; 475786, 3666386; 475788, 3666383; 475789, 3666381; 475791, 3666379; 475793, 3666376; 475794, 3666374; 475796, 3666372; 475798, 3666369; 475799, 3666367; 475801, 3666364; 475802, 3666362; 475803, 3666359; 475805, 3666357; 475806, 3666354; 475807, 3666351; 475808, 3666349; 475810, 3666346; 475811, 3666343; 475812, 3666341; 475813, 3666338; 475814, 3666335; 475814, 3666332; 475815, 3666330; 475816, 3666327; 475817, 3666324; 475817, 3666321; 475818, 3666318; 475819, 3666315; 475819, 3666313; 475820, 3666310; 475820, 3666307; 475820, 3666304; 475820, 3666301; 475821, 3666298; 475821, 3666295; 475821, 3666292; 475821, 3666289; 475821, 3666287; 475821, 3666284; 475821, 3666281; 475821, 3666278; 475820, 3666275; 475820, 3666272; 475820, 3666269; 475820, 3666266; 475819, 3666263; 475819, 3666261; 475818, 3666258; 475817, 3666255; 475817, 3666252; 475816, 3666249; 475815, 3666246; 475814, 3666244; 475814, 3666241; 475813, 3666238; 475812, 3666235; 475811, 3666233; 475810, 3666230; 475808, 3666227; 475807, 3666225; 475806, 3666222; 475806, 3666222; 475810, 3666213; 475814, 3666204; 475818, 3666195; 475821, 3666185; 475823, 3666176; 475825, 3666166; 475825, 3666166; 475828, 3666141; 475829, 3666132; 475829, 3666122; 475829, 3666118; 475791, 3666114; 475770, 3666086; 475762, 3666044.

            (iv) Note: Map of Unit 1, subunits 1A, 1B, and 1C (Map 2), follows:
            BILLING CODE 4310-55-P

              EP13MY08.000

            Dated: May 1, 2008.
            Lyle Laverty,
            Assistant Secretary for Fish and Wildlife and Parks.

       [FR Doc. E8-10499 Filed 5-12-08; 8:45 am]
      BILLING CODE 4310-55-C


        FEDERAL COMMUNICATIONS COMMISSION
        47 CFR Part 5
        [ET Docket Nos. 10-236, 06-155; FCC 15-76]
        Radio Experimentation and Market Trials

          AGENCY:
          Federal Communications Commission.

          ACTION:
          Proposed rule.

          SUMMARY:
          In this document, the Commission proposes to modify the rules for program experimental licenses to permit experimentation for radio frequency (RF)-based medical devices, if the device being tested is designed to comply with all applicable service rules in Part 18, Industrial, Scientific, and Medical Equipment; Part 95, Personal Radio Services Subpart H—Wireless Medical Telemetry Service; or Part 95, Subpart I—Medical Device Radiocommunication Service. This proposal is designed to establish parity between all qualified medical device manufacturers for conducting basic research and clinical trials with RF-based medical devices as to permissible frequencies of operation.

          DATES:
          Comments must be filed on or before September 30, 2015 and reply comments must be filed on or before October 15, 2015.

          ADDRESSES:
          You may submit comments, identified by ET Docket Nos. 10-236 and 06-155, by any of the following methods:
           Federal Communications Commission's Web site: http://apps.fcc.gov/ecfs/. Follow the instructions for submitting comments.

           People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email: FCC504@fcc.gov or phone: 202-418-0530 or TTY: 202-418-0432.

          For detailed instructions for submitting comments and additional information on the rulemaking process, see the SUPPLEMENTARY INFORMATION section of this document.

          FOR FURTHER INFORMATION CONTACT:

          Rodney Small, Office of Engineering and Technology, (202) 418-2452, email: Rodney.Small@fcc.gov, TTY (202) 418-2989.

        SUPPLEMENTARY INFORMATION:
        This is a summary of the Commission's Further Notice of Proposed Rulemaking (FNPRM), ET Docket Nos. 10-236 and 06-155, FCC 15-76, adopted July 6, 2015, and released July 8, 2015. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Center (Room CY-A257), 445 12th Street SW., Washington, DC 20554. The full text may also be downloaded at: www.fcc.gov. People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).
        Summary of Further Notice of Proposed Rulemaking
        1. In two April 2015 filings, Medtronic, Inc. (Medtronic) observes that program licenses “may not be issued for operation on frequencies listed in § 15.205 of the rules, which includes the 401-406 MHz Medical Device Radiocommunications Service (`MedRadio') band often employed by makers of implanted and body-worn medical devices.” Medical testing licensees, on the other hand, may use those frequencies, if they comply with applicable service rules. Medtronic therefore argues that this disparity in frequencies contributes to program licensees being less flexible than medical testing licensees.
        2. As discussed in the companion Memorandum Opinion & Order in this proceeding, basic medical research and experimentation would be conducted under a program (or conventional) license by any manufacturer of RF-based medical devices, whether that manufacturer is eligible for a medical testing license or not. The Commission created the program experimental license to reduce regulatory delay and uncertainty and to promote innovation. A program license is granted for a five year term and allows the licensee to conduct multiple unrelated experiments within a broad range of frequencies. Because researchers can modify the scope of their experiments without having to obtain Commission permission to do so, the flexibility provided will accelerate innovation in RF technology, including RF-based medical devices. However, the program license rules do not permit experimentation in frequency bands that are restricted under § 15.205(a) of the Commission's Rules to protect the many safety-of-life and passive services that operate in these bands.
        3. Medtronic rightly points out that the 401-406 MHz band is a restricted band under § 15.205(a) and is not available for basic research under the program license rules. However, the 401-406 MHz band is used for implanted and body worn medical devices under the part 95 MedRadio rules. Consequently, manufacturers of certain RF-based medical devices cannot take advantage of the benefits provided by a program license to advance innovation in this area, even though the devices they ultimately develop could be authorized for use under the Commission's rules. Because clinical trials conducted under the medical testing license or as a market trial may be tested in these bands, the Commission sees no reason to impose greater frequency restrictions on program licensees conducting basic research on the same devices.

        4. Accordingly, the Commission proposes to modify the rules for program licenses to permit experimentation on frequencies listed in § 15.205(a) of the Commission's rules, provided that—comparable to the rules for medical testing licenses—the device being tested is designed to comply with all applicable service rules in part 18, Industrial, Scientific, and Medical Equipment; part 95, Personal Radio Services Subpart H—Wireless Medical Telemetry Service; or part 95, Subpart I—Medical Device Radiocommunication Service. The proposed rule changes are shown below. These changes would establish parity between all qualified medical device manufacturers for conducting basic research and clinical trials with RF-based medical devices (as defined in § 5.402(b) of the Commission's Rules) as to permissible frequencies of operation.
        Procedural Matters
        A. Ex Parte Rules

        5. This proceeding shall continue to be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 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 § 1.1206(b). In proceedings governed by § 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.
        B. Initial Regulatory Flexibility Certification
        6. The Regulatory Flexibility Act (RFA) requires that an agency prepare a regulatory flexibility analysis for notice-and-comment rulemaking 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 “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).
        7. This FNPRM proposes only a single change to the rules adopted in the Report and Order in this proceeding (78 FR 25138, April 29, 2013), and that proposed change would merely make available to program experimental radio licensees that undertake experiments with medical devices the same frequencies that are currently available to medical testing experimental radio licensees. The entities affected by the proposed rule change are equipment manufacturers seeking to test medical equipment designed to operate in the restricted frequency bands listed in § 15.205(a) of the Commission's rules, and such manufacturers are very limited in number. Thus, the proposal in the FNPRM will not have a substantial economic impact on a significant number of small entities.

        8. The Commission therefore certifies, pursuant to the RFA, that the proposal in this FNPRM, if adopted, will not have a significant economic impact on a substantial number of small entities. If commenters believe that the proposal discussed in the FNPRM requires additional RFA analysis, they should include a discussion of these issues in their comments and additionally label them as RFA comments. The Commission will send a copy of the FNPRM, including a copy of this initial certification, to the Chief Counsel for Advocacy of the SBA. In addition, a copy of the FNPRM and this initial certification will be published in the Federal Register.
        9. Initial Paperwork Reduction Act Analysis: This FNPRM does not contain a proposed information collection subject to the Paperwork Reduction Act of 1995, Public Law 104-13.
        10. Comment Filing Instructions: Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415, 1.419, interested parties may file comments and reply comments on or before the dates indicated on 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).

         Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS: http://fjallfoss.fcc.gov/ecfs2/.

         Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. If more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number.
        Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.

         All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
         Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
         U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.

          People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty). Comments, reply comments, and ex parte submissions will be available for public inspection during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street SW., CY-A257, Washington, DC 20554. These documents will also be available via ECFS. Documents will be available electronically in ASCII, Microsoft Word, and/or Adobe Acrobat.
        Ordering Clauses

        11. Pursuant to section 4(i), 301, 303 and 405 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 301, 303, and 405 and § 1.1, 1.2, and 1.429 of the Commission's rules, 47 CFR 1.1, 1.2, and 1.429, this Further Notice of Proposed Rulemaking is adopted.

        12. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this Further Notice of Proposed Rule Making, including the Initial Regulatory Flexibility Certification, to the Chief, Counsel for Advocacy of the Small Business Administration.

          List of Subject in 47 CFR Part 5
          Radio, Reporting and recordkeeping requirements.

          Federal Communications Commission.
          Marlene H. Dortch,
          Secretary.

        Proposed Rule Change
        For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 5 as follows:

          PART 5—EXPERIMENTAL RADIO SERVICE

        1. The authority citation for part 5 continues to read as follows:

          Authority:
           Secs. 4, 302, 303, 307, 336 48 Stat. 1066, 1082, as amended; 47 U.S.C. 154, 302, 303, 307, 336. Interpret or apply sec. 301, 48 Stat. 1081, as amended; 47 U.S.C. 301.

        2. Section 5.303 is revised to read as follows:

          § 5.303
          Frequencies.
          (a) Licensees may operate in any frequency band, including those above 38.6 GHz, except for frequency bands exclusively allocated to the passive services (including the radio astronomy service). In addition, licensees may not use any frequency or frequency band below 38.6 GHz that is listed in § 15.205(a) of this chapter.
          (b) Exception: Licensees may use frequencies listed in § 15.205(a) of this chapter for testing medical devices (as defined in § 5.402(b) of this chapter), if the device is designed to comply with all applicable service rules in part 18, Industrial, Scientific, and Medical Equipment; part 95, Personal Radio Services Subpart H—Wireless Medical Telemetry Service; or part 95, Subpart I—Medical Device Radiocommunication Service.

      [FR Doc. 2015-21294 Filed 8-28-15; 8:45 am]
       BILLING CODE 6712-01-P