        DEPARTMENT OF HEALTH AND HUMAN SERVICES
        Centers for Medicare & Medicaid Services
        42 CFR Part 493
        [CMS-3271-P]
        RIN 0938-AS04
        Clinical Laboratory Improvement Amendments (CLIA); Fecal Occult Blood (FOB) Testing

          AGENCY:
          Centers for Medicare & Medicaid Services (CMS); Centers for Disease Control and Prevention (CDC), HHS.

          ACTION:
          Proposed rule.

          SUMMARY:
          This proposed rule would amend the Clinical Laboratory Improvement Amendments (CLIA) regulations to clarify that the waived test categorization applies only to non-automated fecal occult blood tests. In addition, the proposed rule would remove the hemoglobin by copper sulfate method from the list of waived tests if commenters confirm that the method is no longer used.

          DATES:
          To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 6, 2015.

          ADDRESSES:
          In commenting, please refer to file code CMS-3271-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
          You may submit comments in one of four ways (please choose only one of the ways listed):
          1. Electronically. You may submit electronic comments on this regulation to http://www.regulations.gov. Follow the “Submit a comment” instructions.
          2. By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3271-P, P.O. Box 8010, Baltimore, MD 21244-1850.
          Please allow sufficient time for mailed comments to be received before the close of the comment period.
          3. By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-3271-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
          4. By hand or courier. Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following addresses prior to the close of the comment period: a. For delivery in Washington, DC—Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445-G, Hubert H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 20201.

          (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)

          b. For delivery in Baltimore, MD—Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
          If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
          Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

          For information on viewing public comments, see the beginning of the SUPPLEMENTARY INFORMATION section.

          FOR FURTHER INFORMATION CONTACT:
          Nancy Anderson, CDC, (404) 498-2280. Judith Yost, CMS, (410) 786-3531.

        SUPPLEMENTARY INFORMATION:

          Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following Web site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to view public comments.
        Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
        I. Background
        The Clinical Laboratory Improvement Amendments of 1988 (CLIA) (section 353 of the Public Health Service Act, codified at 42 U.S.C. 263a) requires any facility performing examinations of human specimens (for example, tissue, blood, and urine) for diagnosis, prevention, or treatment purposes to be certified by the Secretary of the Department of Health and Human Services (HHS). The objective of the CLIA program is to ensure accurate and reliable laboratory testing. The Centers for Medicare & Medicaid Services (CMS) is responsible for the administration of CLIA. The Centers for Disease Control and Prevention (CDC) provides scientific and technical support/consultation to HHS/CMS. The Food and Drug Administration (FDA) is responsible for test categorization.
        To enroll in the CLIA program, laboratories must first register by completing an application; pay applicable certificate fees; be surveyed, if applicable; and become certified. CLIA fees are based on the type of certificate requested by the laboratory (that is, waived, provider-performed microscopy (PPM), accreditation, or compliance) and, for laboratories that perform moderate and high complexity testing, the annual volume and types of testing performed. Waived and PPM laboratories may apply directly for their certificates, as they are not subject to routine surveys.
        To receive a certificate of waiver (COW) under CLIA, a laboratory must only perform tests listed as waived in the CLIA regulations at 42 CFR 493.15(c) (for example, blood glucose by glucose monitoring devices cleared by the FDA for home use) or tests which the FDA has determined to be waived because they are simple with an insignificant risk of error. Waived tests are exempt from most CLIA requirements, and the laboratories that perform them receive no routine surveys.
        Waived laboratories must meet only the following requirements under CLIA:
        • Enroll in the CLIA program;
        • Pay applicable certificate fees biennially; and
        • Follow manufacturers' test instructions.

        Since the implementation of the CLIA program in 1992, the types of tests waived under CLIA have increased from 8 to currently119 tests; consequently, the percentage of laboratories issued a COW has grown significantly from 20 percent to almost 70 percent of the approximate 230,000 laboratories enrolled.

        Dipstick or tablet reagent urinalysis (non-automated) and fecal occult blood (FOB) are two of the original 8 waived tests published in the Federal Register in 1992, listed at 42 CFR 493.15(c)(1) and (c)(2). The regulation specifies that waived test status is applicable to the “non-automated” dipstick or tablet reagent urinalysis, but it does not specify “non-automated” for FOB tests. At the time the regulation was adopted, the FOB was a manual or non-automated test method. However, there are automated FOB analyzers that use complex and sophisticated technology, which do not meet the CLIA criteria for waiver and, therefore, should not be waived. It, therefore, is important to clarify these tests are not included in the list of tests waived in the CLIA regulations. As a result, we propose to revise the current regulation at § 493.15(c)(2) to clarify that only non-automated FOB tests are automatically waived by regulation.
        Furthermore, since the development and proliferation of the waived test for hemoglobin by single analyte instruments with self-contained or component features, as described at § 493.15(c)(9), it is our understanding that the non-automated hemoglobin by copper sulfate method at § 493.15(c)(6) may no longer be in use. Therefore, we are soliciting comments to determine if the waived test at § 493.15(c)(6) Hemoglobin—copper sulfate—non-automated is still in use. If comments support the premise that this test is not in use, we propose to remove the test from the regulation.
        II. Provisions of the Proposed Regulations
        We propose to revise § 493.15(c)(2) by adding the words “non-automated” following “fecal occult blood.” This change would clarify the categorization of the more complex automated FOB analyzers.
        In addition, we propose to remove the hemoglobin by copper sulfate method from the list of waived tests at § 493.15(c)(6) if commenters confirm that the method is no longer used.
        Finally, we propose to renumber the remaining paragraphs if § 493.15(c)(6) is removed.
        III. Collection of Information Requirements
        This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995.
        IV. Response to Comments

        Because of the large number of public comments we normally receive on Federal Register documents, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in the DATES section of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
        V. Regulatory Impact Statement
        We have examined the impact of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (Pub. L. 96-354, September 19, 1980), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
        Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach this economic threshold and thus is not considered a major rule.
        This proposed rule would amend the CLIA regulations at 42 CFR 493.15(c)(2) to clarify that only non-automated FOB tests are specifically waived by regulation. Automated test systems that detect FOB would, therefore, be subject to test categorization by the FDA as moderate or high complexity as described in § 493.17. These test systems would only be considered for waiver approval if the manufacturer submits a waiver application to FDA demonstrating the particular test system meets the statutory waiver criteria of being simple and having an insignificant risk by the user of an erroneous result.

        As of April 5, 2013, the FDA CLIA test categorization database includes 111 FOB test systems. Two of these test systems are automated and are categorized by the FDA as moderate (non-waived) complexity; all others are waived non-automated methods (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm). However, because of the language in the current regulation governing FOB, it could be construed that automated FOB test systems are available for use by laboratories with a COW. If this proposed rule is finalized, these two automated test systems and any automated FOB systems that are developed in the future, will not be available for use by a laboratory with a COW under § 493.15(c)(2). This means that testing sites using one or both of the two automated test systems noted above (that are categorized as moderate complexity tests) would be impacted by this rule if they are currently operating under a COW. Due to the low number of automated analyzers for FOB testing distributed in the United States, we estimate that less than 10 laboratories would be impacted by this proposed regulatory change.
        Furthermore, our second proposal, the removal of the provision governing hemoglobin by the copper sulfate method at § 493.15 (c)(6) is not expected to affect any laboratories, as we believe that it is no longer in use. Therefore, we believe the proposed regulatory changes outlined in this proposed rule would have little or no economic impact if they were to be finalized, and would not reach the economic threshold to be considered a major rule. We welcome comments and supporting data regarding the potential impact of this change.

        The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We believe approximately 73 percent of United States medical laboratories qualify as small entities based on their nonprofit status as reported in the American Hospital Association Fast Fact Sheet, updated January 3, 2013 (http://www.aha.org/research/rc/stat-studies/fast-facts.shtml). However, as previously described, due to the low number of automated analyzers distributed in the United States, we estimate that less than 10 laboratories would potentially be impacted by this regulatory change. As its measure of significant economic impact on a substantial number of small entities, HHS uses a change in revenue of more than 3 to 5 percent. We do not believe that this threshold would be reached by the requirements in this proposed rule because very few small entities would be subject to the provisions in this proposed rule.
        In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We do not expect this proposed rule, if finalized, would have a significant impact on a substantial number of small rural hospitals. The changes proposed in this rule would apply only to the laboratories previously described, which do not include any small rural hospitals at this time. Thus, an analysis under section 1102(b) of the Act is not required for this rulemaking.
        Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This proposed rule would not impose any mandates on state, local, or tribal governments. The impact on the private sector would be less than the threshold.
        Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this proposed regulation would not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
        For reasons listed above, we believe this regulatory change would result in little or no economic impact. This proposed rule does not reach the economic threshold and thus is not considered a major rule. We are requesting comments and additional data to assist us in making a more thorough and accurate prediction of impact in the final rule.

          List of Subjects in 42 CFR Part 493
          Administrative practice and procedure, Grant programs-health, Health facilities, Laboratories, Medicaid, Medicare, Penalties, Reporting and recordkeeping requirements.

        For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 493 as set forth below:

          PART 493—LABORATORY REQUIREMENTS

        1. The authority citation for part 493 continues to read as follows:

          Authority:
          Sec. 353 of the Public Health Service Act, secs. 1102, 1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence following 1395x(s)(11) through 1395x(s)(16)), and the Pub. L. 112-202 amendments to 42 U.S.C. 263a.

        2. Section 493.15 is amended by—
        A. Revising paragraph (c)(2).
        B. Removing paragraph (c)(6).
        C. Redesignating paragraphs (c)(7) through (c)(9) as paragraphs (c)(6) through (c)(8).
        The revision reads as follows:

          § 493.15
          Laboratories performing waived tests.

          (c) * * *
          (2) Fecal occult blood-non-automated;

          Dated: June 18, 2014.
          Marilyn Tavenner,
          Administrator, Centers for Medicare & Medicaid Services.

          Dated: June 18, 2014.
          Thomas R. Frieden,
          Director, Centers for Disease Control and Prevention, Administrator, Agency for Toxic Substances and Disease Registry.

           Dated: September 18, 2014.
          Sylvia M. Burwell,
          Secretary, Department of Health and Human Services.

      [FR Doc. 2014-26559 Filed 11-6-14; 8:45 am]
      BILLING CODE 4120-01-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 180
        [OPP-2002-0280; FRL-7278-3]
        Pesticides; Minimal Risk Tolerance Exemptions

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          This document proposes to reorganize certain existing tolerance exemptions.  All of these chemical substances were reviewed as part of the tolerance reassessment process required under the Food Quality Protection Act of 1996 (FQPA).  As a result of that review, certain chemical substances are now classified as “minimal risk,” and are therefore being shifted to the section of 40 CFR part 180 that holds minimal risk chemical substances. The Agency is merely moving certain tolerance exemptions from one section of the CFR to another section:   No tolerance exemptions are lost as a result of this action.

          DATES:
          Comments, identified by docket ID number OPP-2002-0280, must be received on or before January 21, 2003.

          ADDRESSES:

          Comments may be submitted electronically, by mail, or through hand delivery/courier.  Follow the detailed instructions as provided in Unit I. of the SUPPLEMENTARY INFORMATION.

          FOR FURTHER INFORMATION CONTACT:
          Kathryn Boyle, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (703)  305-6304; fax number: (703) 305-0599; e-mail address: boyle.kathryn@epa.gov.

        SUPPLEMENTARY INFORMATION:
        I.  General Information
        A.  Does This Action Apply to Me?
        You may be potentially affected by this action if you formulate or market pesticide products or if you market certain pesticides that have been exempted from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pursuant to section 25(b) of FIFRA.  Potentially affected categories and entities may include, but are not limited to:
        • Crop production (NAICS 111)
        • Animal production  (NAICS 112)
        • Food manufacturing (NAICS 311)
        • Pesticide manufacturing (NAICS 32532)
        • Antimicrobial pesticides (NAICS 32561)

        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. How Can I Get Copies of This Document and Other Related Information?
        1. Docket.  EPA has established an official public docket for this action under docket identification (ID) number OPP-2002-0280.  The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action.  Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.  The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.  This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.  The docket telephone number is (703) 305-5805.
        2. Electronic access.  You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/.   A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml _00/Title_40/40cfr180_00.html, a beta site currently under development.
        An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets.  You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically.  Once in the system, select “search,” then key in the appropriate docket ID number.
        Certain types of information will not be placed in the EPA Dockets.  Information claimed as CBI and other information whose disclosure is restricted by statute, which is not included in the official public docket, will not be available for public viewing in EPA's electronic public docket.  EPA's policy is that copyrighted material will not be placed in EPA's electronic public docket but will be available only in printed, paper form in the official public docket.  To the extent feasible, publicly available docket materials will be made available in EPA's electronic public docket.  When a document is selected from the index list in EPA Dockets, the system will identify whether the document is available for viewing in EPA's electronic public docket. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1.  EPA intends to work towards providing electronic access to all of the publicly available docket materials through EPA's electronic public docket.
        For public commenters, it is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EPA's electronic public docket as EPA receives them and without change, unless the comment contains copyrighted material, CBI, or other information whose disclosure is restricted by statute.  When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EPA's electronic public docket.  The entire printed comment, including the copyrighted material, will be available in the public docket.
        Public comments submitted on computer disks that are mailed or delivered to the docket will be transferred to EPA's electronic public docket.  Public comments that are mailed or delivered to the docket will be scanned and placed in EPA's electronic public docket.  Where practical, physical objects will be photographed, and the photograph will be placed in EPA's electronic public docket along with a brief description written by the docket staff.
        C.  How and To Whom Do I Submit Comments?
        You may submit comments electronically, by mail, or through hand delivery/courier.  To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your comment.  Please ensure that your comments are submitted within the specified comment period.  Comments received after the close of the comment period will be marked “late.”  EPA is not required to consider these late comments. If you wish to submit CBI or information that is otherwise protected by statute, please follow the instructions in Unit I.D.   Do not use EPA Dockets or  e-mail to submit CBI or information protected by statute.
        1. Electronically.  If you submit an electronic comment as prescribed in this unit, EPA recommends that you include your name, mailing address, and an e-mail address or other contact information in the body of your comment.  Also include this contact information on the outside of any disk or CD ROM you submit, and in any cover letter accompanying the disk or CD ROM.  This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment.  EPA's policy is that EPA will not edit your comment, and any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.  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.
        i. EPA Dockets.  Your use of EPA's electronic public docket to submit comments to EPA electronically is EPA's preferred method for receiving comments.  Go directly to EPA Dockets at http://www.epa.gov/edocket, and follow the online instructions for submitting comments.  Once in the system, select “search,” and then key in docket ID number OPP-2002-0280.  The system is an “anonymous access” system, which means EPA will not know your identity, e-mail address, or other contact information unless you provide it in the body of your comment.
        ii. E-mail.  Comments may be sent by e-mail  to opp-docket@epa.gov, Attention: Docket ID Number OPP-2002-0280.  In contrast to EPA's electronic public docket, EPA's e-mail system is not an “anonymous access” system.  If you send an e-mail comment directly to the docket without going through EPA's electronic public docket, EPA's e-mail system automatically captures your e-mail address.  E-mail addresses that are automatically captured by EPA's e-mail system are included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket.
        iii. Disk or CD ROM.  You may submit comments on a disk or CD ROM that you mail to the mailing address identified in Unit I.C.2.  These electronic submissions will be accepted in WordPerfect or ASCII file format.  Avoid the use of special characters and any form of encryption.
        2. By mail.  Send your comments to:  Public Information and Records Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC, 20460-0001, Attention: Docket ID Number OPP-2002-0280.
        3. By hand delivery or courier.  Deliver your comments to:  Public Information and Records Integrity Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket ID Number OPP-2002-0280. Such deliveries are only accepted during the docket's normal hours of operation as identified in Unit I.A.1.
        D.  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.  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).  Information so marked will not be disclosed except in accordance with 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 listed under FOR FURTHER INFORMATION CONTACT.
        E.  What Should I Consider as I Prepare My Comments for EPA?
        You may find the following suggestions helpful for preparing your comments:
        1. Explain your views as clearly as possible.
        2. Describe any assumptions that you used.
        3. Provide any technical information and/or data you used that support your views.
        4. If you estimate potential burden or costs, explain how you arrived at your estimate.
        5. Provide specific examples to illustrate your concerns.
        6. Offer alternatives.
        7. Make sure to submit your comments by the comment period deadline identified.

        8. To ensure proper receipt by EPA, identify the appropriate docket ID number in the subject line on the first page of your response. It would also be helpful if you provided the name, date, and Federal Register citation related to your comments.
        II.  What Action is the Agency Taking?
        In the Federal Register published on May 24, 2002 (67 FR 36534) (FRL-6834-8) EPA established a new § 180.950 to list the pesticide chemical substances that are exempted from the requirement of a tolerance based on the Agency's determination that these chemical substances are of “minimal risk.”  As the first step in populating this section, the Agency shifted the existing tolerance exemptions for commonly consumed food commodities, animal feed items, and edible fats and oils to this section.
        This proposed rule shifts existing tolerance exemptions for certain inert ingredients that have been classified by the Agency as List 4A, “minimal risk,” to 40 CFR 180.950.  The decision documents supporting the minimal risk, List 4A-Classification, are in the docket.
        The following tolerance exemptions are being shifted from 40 CFR 180.2:  Citric acid, fumaric acid, lime, sodium chloride, and sulfur.  The following tolerance exemptions are being shifted from 40 CFR 180.1001(c): Animal glue;  bentonite; calcareous shale; calcite;  calcium carbonate; calcium citrate; calcium silicate; α-cellulose; citric acid; coffee grounds; corn dextrin; dextrin; dolomite; graphite; guar gum; gypsum; hydroxyethyl cellulose; hydroxypropyl methylcellulose; iron oxide; kaolinite-type clay;  lecithin; licorice root; magnesium carbonate; magnesium-lime; magnesium oxide; magnesium silicate; magnesium sulfate; methylcellulose; mica; montmorillonite-type clay; potassium aluminum silicate; potassium chloride; potassium citrate; potassium sulfate; silica, hydrated; silicon dioxide, fumed, amorphous; sodium acetate; sodium alginate; sodium aluminum silicate; sodium bicarbonate; sodium carboxymethylcellulose; sodium chloride; sodium sulfate; vermiculite; xanthan gum; zeolite (hydrated alkali aluminum silicate); and zinc oxide.
        The following tolerance exemptions are being shifted from 40 CFR 180.1001(d): Cellulose acetate; graphite; hydroxypropylcellulose; locust bean gum;  paper fiber, deinked or recycled; paper fiber, produced by the kraft (sulfate) or sulfite pulping processes; silicon dioxide, fumed, amorphous; soap bark (quillaja); sodium citrate; and wool fat (anhydrous lanolin).  The following tolerance exemptions are being shifted from 40 CFR 180.1001(e): Calcium carbonate; calcium silicate (hydrated calcium silicate); calcium sulfate; castor oil, u.s.p.; α-cellulose; citric acid; dextrin; graphite; iron oxide; kaolinite-type clay; magnesium carbonate; methylcellulose; montmorillonite-type clay; potassium citrate; silica, amorphous, fumed (crystalline free); silica, hydrated silica; silica aerogel; sodium carboxymethylcellulose, sodium sulfate; sulfur; xanthan gum; and zinc oxide.

        The following tolerance exemptions are also being shifted from: § 180.1036: Hydrogenated castor oil, § 180.1176: Sodium bicarbonate, § 180.1177: Potassium bicarbonate, and § 180.1180: Kaolin.  Because this action merely moves certain tolerance exemptions from one section of the CFR to another section, it will have no substantive or procedural effect on the moved tolerance exemptions.  No tolerance exemptions are lost as a result of this action.
        III.  What is the Agency's Authority for Taking this Action?
        This proposed rule is issued under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170).  Section 408(e) of FFDCA authorizes EPA to establish, modify, or revoke tolerances, or exemptions from the requirement of a tolerance for residues of pesticide chemical substances in or on raw agricultural commodities and processed foods.
        IV.  What is “Minimal Risk?”

        The term “minimal risk” has been used by EPA for over 10 years, and has generally meant List 4A inert ingredient chemical substances. On April 22, 1987 (52 FR 13305), EPA created a series of four lists as part of an initiative to address the risks potentially posed by inert ingredients in pesticide products.  At that time all List 4 inert ingredients were classified as “inerts of minimal concern.”  The 4A Inert Ingredient List was created on November 22, 1989 (54 FR 48314) by subdividing List 4 into Lists 4A and 4B.  List 4B inert ingredients are “inerts for which EPA has sufficient information to reasonably conclude that the current use pattern in pesticide products will not adversely affect public health or the environment.”  List 4A inert ingredients are “minimal risk inert ingredients.”  Only substances on List 4A are permitted to be used as inert ingredients in certain pesticides that have been exempted from FIFRA, 7 U.S.C. 136 et seq., pursuant to section 25(b) of FIFRA, 7 U.S.C. 136w(b).
        Minimal risk does not imply no risk under any circumstances.  Every substance can present some risk in certain circumstances.  Minimal risk is used to indicate a substance for which there is no information to indicate that there is a basis for concern.  Many minimal risk or List 4A substances are naturally occurring substances to which some refinement has occurred, such as beeswax, limestone, red cedar chips, salt, and sugar.  The determination that a chemical substance is minimal risk would be based on a recognition of the overall safety of the chemical (such as very low toxicity or practically non-toxic) considering the widely available information on the chemical substances known properties, and a history of safe use under reasonable circumstances.  Minimal risk (List 4A) chemical substances are recognized as safe for use in all pesticide products subject only to good agricultural practices or good manufacturing practices.  Classification as a List 4A, minimal risk, chemical substance is a high standard to meet. As an example, chemical substances of high acute toxicity are usually not considered for classification to List 4A.  The critical distinction between List 4A minimal risk chemical substances and other chemical substances, is that the Agency does not define how, where, when or in what manner the chemical substance can be used.  Any reasonably foreseeable use of these chemical substances in a pesticide product is not expected to present a risk to humans. Accordingly, there should not be any unreasonable adverse effects from the inclusion of a List 4A chemical substance in a pesticide product to the person applying a pesticide product in and around their home, to a child in a daycare center, or when ingesting a food commodity that has been treated.  A List 4A chemical substance used as an inert ingredient, incorporated into a 25(b) product (meeting all the appropriate exemption criteria) is subject to no Federal regulation under FIFRA except as provided in 40 CFR 152.25(g).
        The Agency must give consideration to all routes of exposure to determine that a chemical substance used in a pesticide product can be classified as minimal risk.  Several of the chemical substances being shifted to the new section are naturally occurring materials that have been referred to as weathered materials.  Weathered materials is the term that the Agency is using to describe a group of substances that could also be referred to as rocks and minerals.  Generally, weathered materials are decayed or weathered rocks that are mostly unrefined, i.e., not altered or manufactured by man.  When referring to weathered materials as mostly unrefined, the Agency is including the mechanical grinding of larger rocks into smaller pieces that are essentially the same, but not the chemical or physical alteration of the rock into a different substance. Naturally occurring materials such as these can contain impurities such as asbestos or silica which can lead to health effects including pneumoconiosis, silicosis, or kaolinosis. To evaluate these effects, the Agency conducted a screening-level assessment on weathered materials that compared an estimated residential exposure to the OSHA threshold limit value (TLV).  A TLV is a limit on inhalation exposure in the workplace.  Only those chemical substances that passed this screening level assessment were considered for List 4A status.
        V.  Nomenclature Changes
        For some of the chemical substances that are being shifted to 40 CFR 180.950, EPA is making minor changes to the chemical substance names that were previously used.  Additionally, the Agency has attempted to identify each of the listed chemical substances using the Chemical Abstracts Service Registry Number (CAS  No.).  The CAS No. provides one of the most distinct and universally accepted means of identifying chemical substances. The lack of a CAS No. will not preclude the Agency from including substances in 40 CFR 180.950.  Generally, there will be only one CAS No. per listed substance; however, it is possible that more than one CAS No. may be appropriate for some substances, such as when there is both a hydrated and anhydrous form.  EPA has both broadened and consolidated names to account for differing terminologies and current usage status. Also, additional information to better define the impurities in some naturally occurring substances and thus limit the inhalation concerns that can occur with naturally-occurring materials in a respirable form may have been added.
        VI.  Issues for Future Agency Actions
        A.  Chemical Substances Being Transferred From List 4A to List 4B
        The proposed rule published in the Federal Register of January 15, 2002 (67 FR 1925) (FRL-6807-8) indicated that several allergen-containing food commodities would be moved from List 4A to List 4B.  The Agency has now determined that there are additional chemical substances that no longer meet the criteria of List 4A.  These chemical substances are acetic acid, activated charcoal, attapulgite clay, gum arabic, and granite.  These chemical substances will be transferred from the Agency's 4A list to the 4B list.  Pesticide products containing these inert ingredients will no longer be considered exempt under FIFRA section 25(b) once that transfer is made.  Manufacturers of such products will have the option of either reformulating their product, substituting a different List 4A inert ingredient, or of registering the product with the Agency. It is noted that vinegar (maximum of 8% acetic acid in solution), a commonly consumed food commodity, is still classified as List 4A.
        B.  Chemical Substances That Have Been Classified as List 4A

        The Agency has classified  more chemical substances as List 4A, and is likely to classify additional chemical substances as List 4A.  Shifting the existing tolerance exemptions for all of these chemical substances to 40 CFR 180.950 is a multi-step process that will continue.  Additionally, on its own initiative, the Agency will propose to establish tolerance exemptions in 40 CFR 180.950 for some chemical substances that are currently classified as List 4A, but do not have tolerance exemptions.  At the conclusion of this multi-step process, all chemical substances classified as List 4A will be included in 40 CFR 180.950 and will thus have tolerance exemptions.
        VII.   Regulatory Assessment Requirements

        This proposed rule merely reorganizes existing exemptions in 40 CFR part 180.  This has no substantive effect and hence causes no impact.  The Agency is acting on its own initiative under FFDCA section 408 (e) in shifting these existing tolerance exemptions to a new section.  Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” subject to review by the Office of Management and Budget (OMB).  Because the proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).

        This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

        Nor does it require any special considerations under Executive Order 12898 entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994) or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).  This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

        Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that these proposed actions will not have significant negative economic impact on a substantial number of small entities.  As noted in this unit, this action will have no substantive or procedural effect on the tolerance exemptions affected.  However, by grouping tolerance exemptions that have qualified as minimal risk inerts in one location in the CFR, this action will make it easier for small entities to efficiently use EPA's tolerance regulations.

        In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999).  Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.”  “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”  This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States.  This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

        For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000).  Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.”  “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, 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.”  This proposed rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175.  Thus, Executive Order 13175 does not apply to this proposed rule.

          List of Subjects in 40 CFR Part 180
          Environmental protection, Administrative practice and procedure, Pesticides and pests, Reporting and recordkeeping requirements.

          Dated:  October 27, 2002.
          Debra Edwards,
          Acting Director, Registration Division, Office of Pesticide Programs.

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

          PART 180—[AMENDED]

          1. The authority citation for part 180 would continue to read as follows:

            Authority:
            21 U.S.C. 321(q), 346(a) and 374.

            § 180.2
            [Amended]

          2. In § 180.2, paragraph (a), is amended by removing “citric acid,” “fumaric acid,” “lime,” “sodium chloride,” and “sulfur.”

          3.  In § 180.950, paragraph (e) is amended by alphabetically adding the following chemical substances to read as follows:

            § 180.950
            Tolerance exemptions for minimal risk active and inert ingredients.

            (e)  *  * *

                Chemical substances
                CAS No.

                Acetic acid, sodium salt
                127-09-3

                Animal glue
                None

                Bentonite
                1302-78-9

                Bentonite, sodian
                85049-30-5

                Calcium oxide silicate (Ca3O(SiO4))
                12168-85-3

                Carbonic acid, calcium salt, (limestone) (marble) (chalk) (mollusc/bivalve shells) (no asbestos and less than 1% crystalline silica)
                1317-65-3

                Carbonic acid, calcium salt (calcite) (no asbestos and less than 1% crystalline silica)
                13397-26-7

                Carbonic acid, calcium salt (1:1), (no asbestos and less than 1% crystalline silica)
                471-34-1

                Carbonic acid, calcium salt (1:1), hexahydrate
                15634-14-7

                Carbonic acid, magnesium salt (1:1) (less than 1% crystalline silica)
                546-93-0

                Carbonic acid, monopotassium salt
                298-14-6

                Carbonic acid, monosodium salt
                144-55-8

                Carob gum (locust bean gum)
                9000-40-2

                Castor oil
                8001-79-4

                Castor oil, hydrogenated
                8001-78-3

                Cellulose
                9004-34-6

                Cellulose acetate
                9004-35-7

                Cellulose, carboxy methyl ether, sodium salt
                9004-32-4

                Cellulose, 2-hydroxyethyl ether
                9004-62-0

                Cellulose, 2-hydroxypropyl ether
                9004-64-2

                Cellulose, 2-hydroxypropyl methyl ester
                9004-65-3

                Cellulose, methyl ether
                9004-67-5

                Cellulose, mixture with cellulose carboxymethyl ether, sodium salt
                51395-75-6

                Cellulose, pulp
                65996-61-4

                Cellulose, regenerated
                68442-85-3

                Citric acid
                77-92-9

                Citric acid, calcium salt
                7693-13-2

                Citric acid, calcium salt (2:3)
                813-94-5

                Citric acid, dipotassium salt
                3609-96-9

                Citric acid, disodium salt
                144-33-2

                Citric acid, monohydrate
                5949-29-1

                Citric acid, monopotassium salt
                866-83-1

                Citric acid, monosodium salt
                18996-35-5

                Citric acid, potassium salt
                7778-49-6

                Citric acid, sodium salt
                994-36-5

                Citric acid, tripotassium salt
                866-84-2

                Citric acid, tripotassium salt monohydrate
                6100-05-6

                Citric acid, trisodium salt
                68-04-2

                Citric acid, trisodium salt, dihydrate
                6132-04-3

                Citric acid, trisodium salt, pentahydrate
                6858-44-2

                Coffee grounds
                68916-18-7

                Dextrins
                9004-53-9

                Dolomite (CaMg(CO3)2) (no asbestos and less than 1% crystalline silica)
                16389-88-1

                Feldspar - group minerals (no asbestos and less than 1% crystalline silica)
                68476-25-5

                Fuller's earth
                8031-18-3

                Fumaric acid
                110-17-8

                Graphite (no asbestos and less than 1% crystalline silica)
                7782-42-5

                Guar gum
                9000-30-0

                Gypsum (sulfuric acid, calcium salt, dihydrate) (no asbestos and less than 1% crystalline silica)
                13397-24-5

                Iron oxide (FeO)
                1345-25-1

                Iron oxide (Fe2O3)
                1309-37-1

                Iron oxide (Fe2O3), hydrate
                12259-21-1

                Iron oxide (Fe3O4)
                1317-61-9

                Kaolin (no asbestos and less than 1% crystalline silica)
                1332-58-7

                *   *   *   *   *

                Lanolin
                8006-54-0

                Lecithins
                8002-43-5

                Lecithins, soya
                8030-76-0

                Licorice Extract
                68916-91-6

                Lime (chemical) dolomitic (magnesium and calcium carbonate) (magnesium-lime)
                12001-27-3

                Magnesium oxide
                1309-48-4

                Magnesium silicon oxide (Mg2Si3O8)
                14987-04-3

                Maltodextrin
                9050-36-6

                Mica - group minerals (no asbestos and less than 1% crystalline silica)
                12001-26-2

                Montmorillonite
                1318-93-0

                Paper
                None

                Perlite (no asbestos and less than 1% crystalline silica)
                130885-09-5

                Perlite, expanded  (no asbestos and less than 1% crystalline silica)
                93763-70-3

                Plaster of Paris (sulfuric acid, calcium salt, hemihydrate); (no asbestos and less than 1% crystalline silica)
                26499-65-0

                Potassium chloride
                7447-40-7

                Silica aerogel

                Silica, amorphous, diatomaceous earth (Kieselguhr)(less than1% crystalline silica)
                61790-53-2

                Silica, amorphous, fumed (crystalline free)
                112945-52-5

                Silica, amorphous, perlite,

                Silica, amorphous, precipitated and gel
                7699-41-4

                Silica (crystalline-free forms only)
                7631-86-9

                Silica gel
                63231-67-4

                Silica gel, precipitated, crystalline-free
                112926-00-8

                Silica, hydrate
                10279-57-9

                Silica, vitreous
                60676-86-0

                Silicic acid, aluminum potassium salt
                1327-44-2

                Silicic acid, aluminum salt
                1327-36-2

                Silicic acid, aluminum salt, hydrate
                1335-30-4

                Silicic acid, aluminum sodium salt (1:1:1)
                12003-51-9

                Silicic acid, aluminum sodium salt
                1344-00-9

                Silicic acid, calcium salt
                1344-95-2

                Silicic acid, calcium salt, (wollastonite) (no asbestos and less than 1% crystalline silica)
                13983-17-0

                Silicic acid, magnesium salt
                1343-88-0

                Silicic acid, magnesium salt, hydrate
                1343-90-4

                Silicic acid, magnesium salt (1:1)
                13776-74-4

                Soapbark (Quillaja saponin)
                1393-03-9

                Sodium alginate
                9005-38-3

                Sodium chloride (table salt)
                7647-14-5

                Sulfur
                7704-34-9

                Sulfuric acid, calcium salt (1:1)
                7778-18-9

                Sulfuric acid, calcium salt, dihydrate (1:1)
                10101-41-4

                Sulfuric acid, calcium salt, hydrate (2:2:1)
                10034-76-1

                Sulfuric acid, magnesium salt, (1:1)
                7487-88-9

                Sulfuric acid, magnesium salt (1:1) heptahydrate
                10034-99-8

                Sulfuric acid, magnesium salt (1:1) monohydrate
                14168-73-1

                Sulfuric acid, monopotassium salt
                7646-93-7

                Sulfuric acid, dipotassium salt
                7778-80-5

                Sulfuric acid, disodium salt
                7757-82-6

                Sulfuric acid, disodium salt, decahydrate
                7727-73-3

                Sulfuric acid, disodium salt, heptadydrate
                13472-39-4

                Vermiculite (no asbestos and less than 1% crystalline silica)
                1318-00-9

                Xanthan gum
                11138-66-2

                Zeolites (excluding erionite; CAS No. 12510-42-8)
                1318-02-1

                Zinc oxide
                1314-13-2

            § 180.1001
            [Amended]

          4.  In § 180.1001 the table in paragraph (c) is amended by removing the following entries:  “Animal glue;”  “Bentonite;” “Calcareous shale;” “Calcite;”  “Calcium carbonate;” “Calcium citrate;” “Calcium silicate;” “α-Cellulose;” “Citric acid;” “Coffee grounds;” “Corn dextrin;”  “Dextrin;”  “Dolomite;” “Graphite;” “Guar gum;”  “Gypsum;” “Hydroxyethyl cellulose;” “Hydroxypropyl methylcellulose;” “Iron oxide;” “Kaolinite-type clay;”  “Lecithin;” “Licorice root;” “Magnesium carbonate;” “Magnesium-lime;”  “Magnesium oxide;” “Magnesium silicate;” “Magnesium sulfate;” “Methylcellulose;” “Mica;” “Montmorillonite-type clay;” “Potassium aluminum silicate;” “Potassium chloride;” “Potassium citrate;” “Potassium sulfate;” “Silica, hydrated;” “Silicon dioxide, fumed, amorphous;” “Sodium acetate; “Sodium alginate;” “Sodium aluminum silicate;” “Sodium bicarbonate;” “Sodium carboxymethylcellulose;” “Sodium chloride;” “Sodium sulfate;” “Vermiculite;” “Xanthan Gum;”  “Zeolite (hydrated alkali aluminum silicate;” “Zinc oxide.”

          5.  In § 180.1001 the table in paragraph (d) is amended by removing the following inert ingredients: “Cellulose acetate (CAS Reg. No. 9004-35-7), minimum number average molecular weight, 28,000; “Graphite;” “Hydroxypropyl cellulose;” “Locust bean gum;” “Paper fiber, deinked or recycled, conforming to 21 CFR 109.30(a)(9) and 21 CFR 176.260;” “Paper fiber, produced by the kraft (sulfate) or sulfite pulping processes;” “Silicon dioxide, fumed, amorphous;” “Soap bark (quillaja);” “Sodium citrate;” “Wool fat (anhydrous lanolin).”

          6.  In § 180.1001 the table in paragraph (e) is amended by removing the following inert ingredients: “Calcium carbonate;” Calcium silicate (hydrated calcium silicate);” Calcium sulfate;” “Castor oil, U.S.P.;” “α-Cellulose;” “Citric acid;” “Dextrin (CAS Reg. No. 9004-53-9);”  “Graphite;” “Iron Oxide (CAS Reg. No. 1309-37-1);” “Kaolinite-type clay;” “Magnesium carbonate;” “Methylcellulose;” “Montmorillonite-type clay;” “Potassium citrate (CAS Reg. No. 866-84-2);” “Silica, amorphous, fumed (crystalline free) (CAS Reg. No. 112945-52-5);” “Silica, hydrated silica,;” “Silica aerogel (finely powdered microcellular silica foam having a minimum silica content of 89.5%);” “Sodium carboxymethylcellulose;” “Sodium sulfate;” “Sulfur (CAS Reg. No. 7704-34-9);” “Xanthan gum;” “Zinc oxide.”

            § 180.1036
            [Removed]

          7.  Section 180.1036 is removed.

            § 180.1176
            [Removed]

          8.  Section 180.1176 is removed.

            § 180.1177
            [Removed]

          9.  Section 180.1177 is removed.

            § 180.1180
            [Removed]

          10.  Section 180.1180 is removed.

      [FR Doc. 02-29172 Filed 11-19-02; 8:45 am]
      BILLING CODE 6560-50-S


        NATIONAL AERONAUTICS AND SPACE ADMINISTRATION
        48 CFR Parts 1827, 1828, 1829, 1830, 1831, 1832, and 1833
        RIN 2700-AC68
        Re-Issuance of NASA FAR Supplement Subchapter E

          AGENCY:
          National Aeronautics and Space Administration.

          ACTION:
          Proposed rule.

          SUMMARY:

          This proposed rule would amend the NASA FAR Supplement (NFS) by removing from the Code of Federal Regulations (CFR) those portions of the NFS containing information that consists of internal Agency administrative procedures and guidance that does not control the relationship between NASA and contractors or prospective contractors. This change is consistent with the guidance and policy in FAR Part 1 regarding what comprises the Federal Acquisition Regulations System and requires publication for public comment. The NFS document will continue to contain both information requiring codification in the CFR and internal Agency guidance in a single document that is available on the Internet. This change will reduce the administrative burden and time associated with maintaining the NFS by only publishing in the Federal Register for codification in the CFR material that is subject to public comment.

          DATES:
          Comments should be submitted on or before May 11, 2004 to be considered in formulation of the final rule.

          ADDRESSES:

          Interested parties may submit comments, identified by RIN number 2700-AC86, via the Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments may also be submitted to Celeste Dalton, NASA, Office of Procurement, Contract Management Division (Code HK), Washington, DC 20546. Comments can also be submitted by e-mail to: Celeste.M.Dalton@nasa.gov.

          FOR FURTHER INFORMATION CONTACT:

          Celeste Dalton, NASA, Office of Procurement, Contract Management Division (Code HK); (202) 358-1645; e-mail: Celeste.M.Dalton@nasa.gov

        SUPPLEMENTARY INFORMATION:
        A. Background

        Currently the NASA FAR Supplement (NFS) contains information to implement or supplement the FAR. This information contains NASA's policies, procedures, contract clauses, solicitation provisions, and forms that govern the contracting process or otherwise control the relationship between NASA and contractors or prospective contractors. The NFS also contains information that consists of internal Agency administrative procedures and guidance that does not control the relationship between NASA and contractors or prospective contractors. Regardless of the nature of the information, as a policy, NASA has submitted to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) and published in the Federal Register all changes to the NFS. FAR 1.101 states in part that the “Federal Acquisition Regulations System consists of the Federal Acquisition Regulation (FAR), which is the primary document, and agency acquisition regulations that implement or supplement the FAR. The FAR System does not include internal agency guidance of the type described in 1.301(a)(2).” FAR 1.301(a)(2) states in part “an agency head may issue or authorize the issuance of internal agency guidance at any organizational level (e.g., designations and delegations of authority, assignments of responsibilities, work-flow procedures, and internal reporting requirements).” Further, FAR 1.303 states that issuances under FAR 1.301(a)(2) need not be published in the Federal Register. Based on the foregoing, NASA is not required to publish and codify internal Agency guidance.

        This proposed rule will modify the existing practice by only publishing those regulations which may have a significant effect beyond the internal operating procedures of the Agency or have a significant cost or administrative impact on contractors or offerors. The NFS will continue to integrate into a single document both regulations subject to public comments and internal Agency guidance and procedures that do not require public comment. Those portions of the NFS that require public comment will continue to be amended by publishing changes in the Federal Register. NFS regulations that require public comment are issued as Chapter 18 of Title 48, CFR. Changes to portions of the regulations contained in the CFR, along with changes to internal guidance and procedures, will be incorporated into the NASA-maintained Internet version of the NFS through Procurement Notices (PNs). The single official NASA-maintained version of the NFS will remain available on the Internet. NASA personnel must comply with all regulatory and internal guidance and procedures contained in the NFS.

        This change will result in savings in terms of the number of rules subject to publication in the Federal Register and provide greater responsiveness to internal administrative changes.
        B. Regulatory Flexibility Act

        This proposed rule is not expected to have a significant economic impact on a substantial number of small entities with the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601. et seq., because this proposed rule would only remove from the CFR information that is considered internal Agency administrative procedures and guidance. The information removed from the CFR will continue to be made available to the public via the Internet.
        C. Paperwork Reduction Act

        The Paperwork Reduction Act does not apply because the changes do not impose recordkeeping or information collection requirements which require the approval of the Office of Management and Budget under 44 U.S.C. 3501, et seq.

          List of Subjects in 48 CFR Parts 1827 through 1833.
          Government Procurement.

          Tom Luedtke,
          Assistant Administrator for Procurement.

        Accordingly, 48 CFR parts 1827 through 1833 are amended as follows:
        1. The authority citation for 48 CFR parts 1827 through 1833 continue to read as follows:

          Authority:
          42 U.S.C. 2473(c)(1).

          PART 1827—PATENTS, DATA, AND COPYRIGHTS
          2. Amend part 1827 by removing sections 1827.305-3, 1827.305-370, 1827.305-371, paragraphs (d), (e), (f), (g)(3)(B), (g)(3)(C), (g)(3)(D), (h), and (i) in section 1827.404, sections 1827.405, 1827.406, 1827.408, and paragraphs (b), (c), (d), and (e) in section 1827.409.

          PART 1828—BONDS AND INSURANCE
          3. Amend part 1828 by removing sections 1828.106, 1828.106-6, Subpart 1828.2, and sections 1828.307, 1828.307-1, 1828.307-2, and 1828.307-70.

          PART 1829—TAXES
          4. Remove part 1829.

          PART 1830—COST ACCOUNTING STANDARDS ADMINISTRATION
          5. Amend part 1830 by removing Subpart 1830.2 and removing and reserving sections 1830.7001-1, 1830.7001-2, and 1830.7001-3.

          PART 1831—CONTRACT COST PRINCIPLES AND PROCEDURES
          6. Amend part 1831 by removing sections 1831.205-6, 1831.205-670, and 1831.205-32, and removing the phrase “under 1831.205-32” in section 1831.205-70.

          PART 1832—CONTRACT FINANCING
          7. Amend part 1832 by—
          (a) Removing sections 1832.006-2, 1832.007;
          (b) Removing “(see 1832.402)” in paragraph (b)(6) of section 1832.202-1; and
          (c) Removing sections 1832.402, 1832.406, 1832.407, 1832.409, 1832.409-1, 1832.409-170, 1832.410, 1832.501-2, 1832.502, 1832.502-2, 1832.503, 1832.503-5, 1832.504, 1832.702, 1832.702-70, 1832.704, 1832.704-70, Subpart 1832.9, and sections 1832.1001, 1832.1004, paragraph (b)(2) in section 1832.1005, and paragraph (c) in section 1832.1110.

          PART 1833—PROTESTS, DISPUTES, AND APPEALS
          8. Amend part 1833 by removing paragraph (f) in section 1833.103, and sections 1833.104, 1833.106, 1833.209, 1833.210, and 1833.211.

      [FR Doc. 04-5693 Filed 3-11-04; 8:45 am]
      BILLING CODE 7510-01-P


        ENVIRONMENTAL PROTECTION AGENCY
        40 CFR Part 52
        [EPA-R09-OAR-2007-1075, FRL-8506-3]
        Revisions to the California State Implementation Plan, Kern County Air Pollution Control District

          AGENCY:
          Environmental Protection Agency (EPA).

          ACTION:
          Proposed rule.

          SUMMARY:
          EPA is proposing to approve revisions to the Kern County Air Pollution Control District (KCAPCD) portion of the California State Implementation Plan (SIP). These revisions concern particulate matter (PM-10) emissions from ambient dust and propellant and rocket testing. We are proposing to approve local rules under the Clean Air Act as amended in 1990 (CAA or the Act).

          DATES:
          Any comments on this proposal must arrive by February 19, 2008.

          ADDRESSES:
          Submit comments, identified by docket number EPA-R09-OAR-2007-1075, by one of the following methods:
          • Federal eRulemaking Portal: www.regulations.gov. Follow the online instructions.
          • E-mail: steckel.andrew@epa.gov.

          • Mail or deliver: Andrew Steckel (Air-4), U.S. Environmental Protection Agency Region IX, 75 Hawthorne Street, San Francisco, CA 94105.

            Instructions: All comments will be included in the public docket without change and may be made available online at www.regulations.gov, including any personal information provided, unless the comment includes Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Information that you consider CBI or otherwise protected should be clearly identified as such and should not be submitted through www.regulations.gov or e-mail. www.regulations.gov is an “anonymous access” system, and EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send e-mail directly to EPA, your e-mail address will be automatically captured and included as part of the public comment. 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.

            Docket: The index to the docket for this action is available electronically at www.regulations.gov and in hard copy at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While all documents in the docket are listed in the index, some information may be publicly available only at the hard copy location (e.g., copyrighted material), and some may not be publicly available in either location (e.g., CBI). To inspect the hard copy materials, please schedule an appointment during normal business hours with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

          FOR FURTHER INFORMATION CONTACT:

          Al Petersen, Rules Office (AIR-4), U.S. Environmental Protection Agency, Region IX, (415) 947-4118, petersen.alfred@epa.gov.

        SUPPLEMENTARY INFORMATION:

        This proposal addresses the approval of KCAPCD Rules 404.1 and 431. In the Rules and Regulations section of this Federal Register, we are approving these local rules in a direct final action without prior proposal because we believe this SIP revision is not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule.
        Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
        We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.

          Dated: November 23, 2007.
          Alexis Strauss,
          Acting Regional Administrator, Region IX.

      [FR Doc. E8-192 Filed 1-16-08; 8:45 am]
      BILLING CODE 6560-50-P


        DEPARTMENT OF COMMERCE
        National Oceanic and Atmospheric Administration
        50 CFR Part 660
        [I.D. 020900B]
        Western Pacific Fishery Management Council; Public Meeting

          AGENCY:
          National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

          ACTION:
          Notice of public meeting; public scoping hearings; public hearing.

          SUMMARY:

          The Western Pacific Fishery Management Council will hold its 102nd meeting in Honolulu, HI. A public hearing will be held on alternatives for managing sharks and creating area closures in American Samoa. These measures will be implemented by amendments to the Fishery Management Plan for the Pelagic Fisheries of the Western Pacific Region (Pelagics FMP). A public scoping hearing will be held on the intent to prepare an Environmental Impact Statement (EIS) for the Fishery Management Plan for the Precious Corals Fisheries of the Western Pacific Region (Precious Corals FMP).

          DATES:

          The Council's Standing Committees will meet on February 28, 2000. The full Council meeting will be held on February 29, 2000 and March 1, and 2, 2000. The public hearings will be held on March 1 and 2, 2000. See SUPPLEMENTARY INFORMATION for specific dates and times for these meetings and hearings.

          ADDRESSES:
          The Council meeting will be held at the Hibiscus Ballroom I at the Ala Moana Hotel, 410 Atkinson Drive, Honolulu, HI 96814; telephone: 808-955-4811.

            Council address: Western Pacific Fishery Management Council, 1164 Bishop St., Suite 1400, Honolulu, HI, 96813.

          FOR FURTHER INFORMATION CONTACT:
          Kitty M. Simonds, Executive Director; telephone: 808-522-8220.

        SUPPLEMENTARY INFORMATION:
        Dates and Times
        Committee Meetings
        The following Council's Standing Committees will meet on February 28, 2000. Enforcement/Vessel Monitoring System (VMS) (including meeting with industry) from 7:30 a.m. to 9:30 a.m.; International Fisheries/Pelagics from 9:30 a.m. to 11:30 a.m.; Bottomfish, Crustaceans, and Ecosystem & Habitat from 1:00 p.m. to 3:00 p.m.; Native and Indigenous Rights from 3:00 p.m. to 4:00 p.m; Precious Corals from 3:00 p.m. to 4:00 p.m.; and Executive/Budget and Program from 4:00 p.m. to 6:00 p.m.
        Full Council meeting
        The full Council will meet on February 29, and March 1-2, 2000, from 8:30 a.m. to 5:00 p.m., each day.
        Public Hearings
        The public hearing on shark management options and area closures around American Samoa will be held on Wednesday, March 1, 2000, at 4:00 p.m. The scoping hearing to add the Commonwealth of the Northern Mariana Islands (CNMI) and the Pacific Remote Island Areas (PRIA) to the Fishery Management Plan for the Bottomfish Fisheries of the Western Pacific Region (Bottomfish FMP) will be held on March 2, 2000, at 9:30 a.m.The scoping hearing to add the CNMI and the PRIA to the Fishery Management Plan for the Crustacean Fisheries of the Western Pacific Region (Crustacean FMP) will be held on Thursday, March 2, 2000, at 4:00 p.m. The scoping hearing on the intent to prepare an EIS and to add the CNMI and the PRIA to the Precious Corals FMP will
        Agenda
        The agenda during the full Council meeting will include the items below. The order in which agenda items are addressed may change. The Council will meet as late as necessary to complete scheduled business.
        1. Introductions
        2. Approval of Agenda
        3. Approval of 101st Meeting Minutes
        4. Island Reports
        A. American Samoa
        B. Guam
        C. Hawaii
        D. Commonwealth of the Northern Mariana Islands (CNMI)
        5. Fishery Agency and Organization Reports
        A. DOC
        (1) NMFS
        (a) Southwest Region, Pacific Island Area Office
        (b) Southwest Fisheries Science Center La Jolla and Honolulu Laboratories
        (2) NOAA General Counsel, Southwest Region
        B. Department of the Interior, Fish and Wildlife Service (FWS)
        6. Enforcement
        A. U.S. Coast Guard (USCG) activities
        B. NMFS activities
        C. Cooperative agreements for Guam/CNMI
        D. Status of violations
        7. VMS
        A. Regional VMS report
        B. National VMS efforts
        C. Report on FFA VMS program
        8. Ecosystems and Habitat
        A. Draft Coral Reef Ecosystem FMP/Preliminary DEIS
        (1) Review of Council's preferred alternative
        (a) fishing permit and reporting
        (b) restriction of gear and methods
        (c) marine protected areas
        (d) framework provision
        (e) process for Plan Team (PT) coordination
        (2) Review of comments from region-wide public meetings
        (3) Federal initiatives
        (a) Congressional coral reef bills
        (b) U.S. Coral Reef Task Force action plan
        (4) Agency research plans for coral reefs
        B. Northwestern Hawaiian Islands (NWHI)
        (1) Concerns regarding existing fisheries
        (a) status of monk seals
        (b) Marine Mammal Commission
        (c) Monk Seal Recovery Team
        (d) agencies:
        (1) NMFS
        (2) Coral Reef Task Force
        (3) FWS
        (4) Hawaii Department of Land and Natural Resources (HDLNR)
        (5) U.S. Navy/USCG
        2. Hawaii advisory body recommendations
        (a) Coral Reef Ecosystem PT
        (b) Ecosystem and Habitat Advisory Panel (AP)
        (c) Bottomfish PT/AP
        (d) Crustacean PT/AP
        (e) Precious Corals PT/AP
        9. Fishery Rights of Indigenous People
        A. Status of Marine Conservation Plans (MCPs)
        B. Status of eligibility criteria for Community Development Program CDP and Demonstration Projects
        C. Limited entry permits for CDP
        10. Pelagic Fisheries
        A. 3rd and 4th quarters 1999 Hawaii and American Samoa longline fishery reports
        B. American Samoa, Framework measure (see agenda item under 10.H)

        The Council will hold a public hearing and take final action on a framework measure under the Pelagics FMP to implement a closed area for pelagic fishing vessels around the islands of American Samoa. In December 1997, at its 94th meeting, the Council voted to recommend a closed area from which large (greater than 50 ft (15.24 m)) pelagic fishing vessels would be excluded to protect the small vessel longline fishery in American Samoa. That proposed revision was adopted under the two meeting framework process. That measure would have established a 50- nautical mile (nm) closure to pelagic fishing vessels larger than 50 ft (15.24 m) around Tutuila and Manua Islands, and a 30-nm closure around Swains Island. The recommended closure was sent to the NMFS Southwest Regional Administrator in October 1998 but was disapproved in March 1999, with the advice that it could be revised to include greater justification for closed areas under National Standard 8 of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act).
        Subsequently, a revised draft of the framework measure has been drafted which includes a preferred alternative which would implement a 50-nm closure to pelagic fishing vessels larger than 50 ft (15.24 m) around Tutuila and Manua Islands, and a 30-nm closure around Swains Island. A copy of the draft document is available from the Council office.
        (2) MCP
        C. Shark management
        (1) Shark catch and disposition in 1999 in Hawaii longline fishery
        (2) Blue shark stock assessment
        (3) Report of cultural study of sharks and shark finning in the western Pacific region
        (4) National Plan of Action-Sharks
        (5) Proposals for shark management
        (6) Pelagics FMP amendment for shark management

        D. Seabird interactions in the Hawaii longline fishery
        (1) Status of amendment
        (2) Biological opinion
        (3) National Plan of Action-Seabirds
        E. Turtle management
        (1) Imposition of longline closed area north of Hawaii
        (2) Status of lawsuit
        F. International
        (1) Multilateral High Level Conference 6
        (2) International Pelagic Shark Workshop
        G. National Plan of Action-Fishing Capacity
        H. Public hearing, shark management options
        At its 101st Meeting, the Council voted to take action on the retention of sharks by the Hawaii longline fishery by setting an annual fleetwide harvest guideline (quota) of 50,000 sharks through an amendment to the Pelagics FMP. The need for a quota was generated by concerns about the level of blue shark mortality in the Hawaii-based longline fishery, since virtually all the shark catch comprises blue shark and the level of retention had risen from less than 14,000 in 1993 to 60,000 in 1998. The same amendment will also develop regulations to ban demersal longline fishing for pelagic management unit species in the Hawaii exclusive economic zone (EEZ). In 1998 and 1999, a fishing vessel from the U.S. mainland fished for sharks with a demersal longline in Hawaii in nearshore coastal waters. This type of longline fishing was not regulated by state and Federal regulations. Various Council advisory bodies found this type of longline fishing inappropriate for Hawaii but recognized that other islands in the western Pacific Region may wish to make use of this gear to exploit their shark stocks. Consequently, the Council was asked to ban its use in Hawaii, but not elsewhere in the region. A copy of the draft amendment is available from the Council office (see ADDRESSES).
        11. Bottomfish Fisheries
        A. Status of the fishery
        B. Review of public scoping comments on EIS alternatives
        C. Addition of CNMI and PRIA to FMP
        D. New entry to Mau Zone
        E. Public comment and scoping hearing on addition of fisheries off CNMI and PRIA to the FMP.
        The Council intends to develop amendments to the Fishery Management Plan for the Bottomfish FMP, and the Precious Corals FMP. In developing these amendments, the Council will consider a range of alternatives and impacts for management of bottomfish, crustacean, and precious coral fisheries of the PRIA and the CNMI. The PRIAs are defined as Kingman Reef, Johnston Atoll, and Howland, Baker, Jarvis, Wake, Midway, and Palmyra islands. The Council is evaluating the need to amend the bottomfish, crustacean, and precious corals FMPs to better achieve the management objectives of these FMPs. Currently, no Federal regulations are in place to manage the bottomfish, crustacean, and precious coral fishery resources in the EEZ waters surrounding the CNMI. There are also no Federal regulations for the bottomfish and crustacean fisheries for the EEZ waters surrounding the PRIAs. The amendments will be developed by considering a wide range of management alternatives to address data shortfalls and possible impacts from the bottomfish, crustacean, and precious coral fisheries in the PRIAs and the CNMI. The Council seeks to solicit public comment and input on a wide range of management alternatives, including, but not limited to, the following: Federal permit and data reporting requirements; limited access; VMS; observer program; closed season; closed areas; gear restrictions; size limits; catch quotas; and prohibitions on the use of destructive fishing techniques, including the use of explosives, poisons, bottomset gill-nets, bottom trawls, and tangle nets.
        12. Crustacean Fisheries
        A. Status of the stocks
        B. Harvest Guideline
        C. Review of public scoping comments on EIS alternatives
        D. Addition of the fisheries off the CNMI and PRIA to FMP
        E. Status of state regulations for NWHI import license
        F. Lawsuit to close lobster and bottomfish fisheries
        G. Public comment and scoping hearing on addition of the fisheries off the CNMI and PRIA (see agenda item 11.E)
        The Council intends to discuss the bank-specific harvest guidelines calculated by NMFS for the year 2000 lobster fishery in the NWHI, review new information presented by NMFS on the status of lobster stocks, and conservation and management issues raised by its advisory groups. In 1999, there was an estimated 20-30 percent decline in the NWHI exploitable lobster population (spiny and slipper lobster combined) based on commercial catch-per-unit-effort (CPUE) data. The overall drop is attributed to lower commercial CPUE in Area 4 which had a considerable increase in effort that was largely exploratory and unsuccessful. Between 1998 to 1999, the commercial CPUE in Area 4 lobster fishing grounds decline from 1.0 to 0.6. The Council will consider whether changes to the existing regulatory regime governing the NWHI crustacean fishery is needed, and if appropriate, may take action, possibly under FMP framework procedures, requesting NMFS to implement management measures. Alternative measures could include additional restrictions or a moratorium on lobster fishing NWHI-wide or at certain lobster fishing grounds.
        13. Precious Corals
        A. Status of the fishery
        B. Status of framework amendment
        C. Review of public scoping comments on EIS alternatives
        D. Addition of the fisheries off the CNMI to FMP
        E. Public scoping hearing on the EIS and public hearing on addition of the fisheries off the CNMI to FMP.

        The Council intends to prepare an EIS on the Federal management of precious corals in the western Pacific Region. The scope of the EIS analysis will include all activities related to the conduct of the fisheries and will examine the impacts of precious coral harvest on, among other things, protected species. A summary of the current Federal management system for precious corals in the western Pacific Region will be reviewed during the public scoping hearing. A principal objective of the scoping and public input process is to identify a reasonable set of management alternatives that, with adequate analysis, will sharply define critical issues and provide a clear basis for choice among the alternatives. The intent of the EIS is to present an overall picture of the environmental effects of fishing as conducted under the FMP. The EIS will discuss the impacts of potential precious coral harvest on the human environment and consider a range of alternatives. Alternatives will be assessed for impacts on essential fish habitat, target and non-target species of fish, discarded fish, marine mammals (Hawaiian monk seals and cetaceans), and other protected species present in the Western Pacific ecosystem. In addition, the environmental consequences section will contain an analysis of socio-economic impacts of the fishery on the following groups of individuals: (1) Those who participate in harvesting the fishery resources and other living marine resources; (2) those who process and market the fish and fish products; (3) those who are involved in allied support industries; (4) those who consume fish products; (5) those who rely on living marine resources in the management area either for subsistence needs or for recreational benefits; (6) those who benefit from non-consumptive uses of living marine resources; (7) those involved in managing and monitoring fisheries; and (8) fishing communities. (Also see agenda item 11.E. for adding CNMI to the FMP)
        14. Program Planning
        A. Magnuson-Stevens Act changes
        B. Report on program planning initiatives
        C. AP modifications
        D. WPacFIN
        E. Fisheries Data Coordinating Committee
        F. Recreational Fisheries Data Task Force
        15. Administrative Matters
        A. Administrative reports
        B. Advisory body membership changes
        C. Meetings and workshops
        D. 103rd Council meeting
        16. Other Business
        A. Election of Council Officers
        Although non-emergency issues not contained in this agenda may come before the Council for discussion, those issues may not be the subject of formal Council action during this meeting. Council action will be restricted to those issues specifically listed in this document and any issue arising after publication of this document that requires emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.
        Special Accommodations
        These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, 808-522-8220 (voice) or 808-522-8226 (fax), at least 5 days prior to the meeting date.

          Authority:
          1801 et
            seq.

          Dated: February 11, 2000.
          Bruce C. Morehead,
          Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.

      [FR Doc. 00-3720 Filed 2-15-00; 8:45 am]
      BILLING CODE 3510-22-F


        DEPARTMENT OF HOMELAND SECURITY
        Federal Emergency Management Agency
        44 CFR Part 67
        [Docket No. FEMA-D-7566]
        Proposed Flood Elevation Determinations

          AGENCY:
          Federal Emergency Management Agency (FEMA), Emergency Preparedness and Response Directorate, Department of Homeland Security.

          ACTION:
          Proposed rule.

          SUMMARY:
          Technical information or comments are requested on the proposed base (1% annual chance) flood elevations and proposed base flood elevation modifications for the communities listed below. The base flood elevations are the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).

          DATES:
          The comment period is ninety (90) days following the second publication of this proposed rule in a newspaper of local circulation in each community.

          ADDRESSES:
          The proposed base flood elevations for each community are available for inspection at the office of the Chief Executive Officer of each community. The respective addresses are listed in the following table.

          FOR FURTHER INFORMATION CONTACT:
          Mary Jean Pajak, P.E., FEMA, 500 C Street, SW., Washington, DC 20472, (202) 646-2831.

        SUPPLEMENTARY INFORMATION:
        The Federal Emergency Management Agency (FEMA or Agency) proposes to make determinations of base flood elevations and modified base flood elevations for each community listed below, in accordance with Section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).

        These proposed base flood and modified base flood elevations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own, or pursuant to policies established by other Federal, state or regional entities. These proposed elevations are used to meet the floodplain management requirements of the NFIP and are also used to calculate the appropriate flood insurance premium rates for new buildings built after these elevations are made final, and for the contents in these buildings.

          National Environmental Policy Act. This proposed rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. No environmental impact assessment has been prepared.

          Regulatory Flexibility Act. The Mitigation Division Director of the Emergency Preparedness and Response Directorate certifies that this proposed rule is exempt from the requirements of the Regulatory Flexibility Act because proposed or modified base flood elevations are required by the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and are required to establish and maintain community eligibility in the NFIP. As a result, a regulatory flexibility analysis has not been prepared.

          Regulatory Classification. This proposed rule is not a significant regulatory action under the criteria of Section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

          Executive Order 12612, Federalism. This proposed rule involves no policies that have federalism implications under Executive Order 12612, Federalism, dated October 26, 1987.

          Executive Order 12778, Civil Justice Reform. This proposed rule meets the applicable standards of Section 2(b)(2) of Executive Order 12778.

          List of Subjects in 44 CFR Part 67
          Administrative practice and procedure, Flood insurance, Reporting and recordkeeping requirements.

        Accordingly, 44 CFR part 67 is proposed to be amended as follows:

          PART 67—[AMENDED]
          1. The authority citation for part 67 continues to read as follows:

            Authority:
            42 U.S.C. 4001 et seq.; Reorganization Plan No. 3 of 1978, 3 CFR, 1978 Comp., p. 329; E.O. 12127, 44 FR 19367, 3 CFR, 1979 Comp., p. 376.

            § 67.4
            [Amended]
            2. The tables published under the authority of § 67.4 are proposed to be amended as follows:

                State
                City/town/county
                Source of flooding
                Location
                # Depth in feet above ground * Elevation in feet (NGVD)
                  • Elevation in feet (NAVD)

                Existing
                Modified

                New York
                Schuyler Falls (Town), Clinton
                Saranac River
                At upstream corporate limits
                * 735
                * 736

                At downstream corporate limits
                * 256
                * 245

                Maps available for inspection at the Schuyler Falls Town Office, 997 Mason Street, Schuyler Falls, New York.

                Send comments to Mr. Harold Ormsby, Town of Schuyler Falls Supervisor, P.O. Box 99, Schuyler Falls, New York 12962.

            (Catalog of Federal Domestic Assistance No. 83.100, “Flood Insurance”)

            Dated: June 18, 2003.
            Anthony S. Lowe,
            Mitigation Division Director, Emergency Preparedness and Response Directorate.

      [FR Doc. 03-16287 Filed 6-26-03; 8:45 am]
      BILLING CODE 6718-04-P