P-17-0299 Sanitized Support Documents Index:
 P-17-0299 Sanitized Determination Document (linked)
 P-17-0299 Sanitized CHEM Report (attached)
 P-17-0299 Sanitized ECO Report (attached)
 P-17-0299 Sanitized ENG Report (attached)
 P-17-0299 Sanitized EXP Report (attached)
 P-17-0299 Sanitized Fate Report (attached)
 P-17-0299 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]
[Page 24711-24718]
[DOCID:fr05my10-102]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451] (formerly Docket No. 2004N-0226)

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 023'' (Recognition List Number: 023), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document
at any time. See section VII of this document for the effective date of
the recognition of standards announced in this document.

ADDRESSES:  Submit written requests for single copies of
``Modifications to the List of Recognized Standards, Recognition List
Number: 023'' to the Division of Small Manufacturers, International,
and Consumer Assistance, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66,

rm. 4613, Silver Spring, MD 20993-0002. Send two self-addressed
adhesive labels to assist that office in processing your requests, or
fax your request to<PHONE_NUMBER>. Submit written comments concerning
this document, or recommendations for additional standards for
recognition, to the contact person (see FOR FURTHER INFORMATION
CONTACT). Submit electronic comments by e-mail<EMAIL_ADDRESS>
This document may also be accessed on FDA's Internet site at http://
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm. See
section VI of this document for electronic access to the searchable
database for the current list of FDA recognized consensus standards,
including Recognition List Number: 023 modifications and other
standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 301-
796-6574.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1 of this
document.

      Table 1.--Previous Publications of Standard Recognition Lists
February 25, 1998 (63 FR 9561)       May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)       November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546)          March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)      June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)            November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774)        May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)        September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391)         December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712)          September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176)          March, 18, 2009 (74 FR 11586)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)        September 8, 2009 (74 FR 46203)
------------------------------------------------------------------------

    These notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The agency maintains ``hypertext
markup language (HTML)'' and ``portable document format (PDF)''
versions of the list of ``FDA Recognized Consensus Standards.'' Both
versions are publicly accessible at the agency's Internet site. See
section VI of this document for electronic access information.
Interested persons should review the supplementary information sheet
for the standard to understand fully the extent to which FDA recognizes
the standard.

II. Modifications to the List of Recognized Standards, Recognition List
Number: 023

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the agency will recognize for
use in satisfying premarket reviews and other requirements for devices.
FDA will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the agency's searchable database. FDA will use
the term ``Recognition List Number: 023'' to identify these current
modifications.
    In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others; (2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.

                           Table 2.--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                          Replacement
 Old Recognition No.    Recognition No.                      Standard                             Change
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-64                  2-153                ANSI/AAMI/ISO 10993-5:2009 Biological         Withdrawn and replaced
                                            Evaluation of Medical Devices--Part 5:        with newer version
                                            Tests for in vitro Cytotoxicity
----------------------------------------------------------------------------------------------------------------
2-67                  2-154                ASTM F756--08 Standard Practice for           Withdrawn and replaced
                                            Assessment of Hemolytic Properties of         with newer version
                                            Materials
----------------------------------------------------------------------------------------------------------------
2-82                  2-155                ASTM F2147-01 (Reapproved 2006) Standard      Withdrawn and replaced
                                            Practice for Guinea Pig: Split Adjuvant and   with newer version
                                            Closed Patch Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
2-87                  ...................  ISO 10993-10:2002 Biological Evaluation of    Title, Extent of
                                            Medical Devices--Part 10: Tests for           recognition, and
                                            Irritation and Delayed-Type                   Relevant guidance
                                            Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-93                  ...................  ASTM F 763--04 Standard Practice for Short-   Extent of recognition
                                            Term Screening of Implant Materials
----------------------------------------------------------------------------------------------------------------

2-94                  ...................  ASTM F 981--04 Standard Practice for          Extent of recognition
                                            Assessment of Compatibility of Biomaterials
                                            for Surgical Implants with Respect to
                                            Effect of Materials on Muscle and Bone
----------------------------------------------------------------------------------------------------------------
2-96                  ...................  ASTM F 1903--98 (Reapproved 2003) Standard    Title and Extent of
                                            Practice for Testing For Biological           recognition
                                            Responses to Particles in vitro
----------------------------------------------------------------------------------------------------------------
2-98                  ...................  ANSI/ AAMI/ ISO 10993-1:2003 Biological       Title, Extent of
                                            Evaluation of Medical Devices--Part 1:        recognition, and
                                            Evaluation and Testing                        Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-100                 ...................  ASTM E 1372--95 (Reapproved 2003) Standard    Title and Extent of
                                            Test Method for Conducting a 90-Day Oral      recognition
                                            Toxicity Study in Rats
----------------------------------------------------------------------------------------------------------------
2-108                 ...................  ASTM F 1905--98 (Reapproved 2003) Standard    Title and Extent of
                                            Practice For Selecting Tests for              recognition
                                            Determining the Propensity of Materials to
                                            Cause Immunotoxicity
----------------------------------------------------------------------------------------------------------------
2-114                 ...................  ASTM F 1877--05 Standard Practice for         Extent of recognition
                                            Characterization of Particles
----------------------------------------------------------------------------------------------------------------
2-115                 ...................  ASTM F 895--84 (Reapproved 2006) Standard     Title, Extent of
                                            Test Method for Agar Diffusion Cell Culture   recognition, and
                                            Screening for Cytotoxicity                    Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-117                 ...................  ANSI/AAMI/ISO 10993-3:2003 Biological         Title, Extent of
                                            Evaluation of Medical Devices--Part 3:        recognition, and
                                            Tests for Genotoxicity, Carcinogenicity,      contact person
                                            and Reproductive Toxicity
----------------------------------------------------------------------------------------------------------------
2-118                 ...................  ANSI/AAMI/ISO 10993-11:2006 Biological        Title, Extent of
                                            Evaluation of Medical Devices--Part 11:       recognition, and
                                            Tests for Systemic Toxicity                   Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-119                 ...................  ASTM F813-07 Standard Practice for Direct     Extent of recognition
                                            Contact Cell Culture Evaluation of
                                            Materials for Medical Devices
----------------------------------------------------------------------------------------------------------------
2-120                 ...................  ANSI/AAMI/ISO 10993-6:2007 Biological         Title and Extent of
                                            Evaluation of Medical Devices--Part 6:        recognition
                                            Tests for Local Effects after Implantation
----------------------------------------------------------------------------------------------------------------
2-122                 ...................  ASTM F 719-81 (Reapproved 2007)e Standard     Title, Extent of
                                            Practice for Testing Biomaterials in          recognition, and
                                            Rabbits for Primary Skin Irritation           Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-123                 ...................  ASTM F 720-81 (Reapproved 2007) Standard      Title, Extent of
                                            Practice for Testing Guinea Pigs for          recognition, and
                                            Contact Allergens: Guinea Pig Maximization    Relevant guidance
                                            Test
----------------------------------------------------------------------------------------------------------------
2-124                 ...................  ASTM F 750-87 (Reapproved 2007)e Standard     Title, Extent of
                                            Practice for Evaluating Material Extracts     recognition, and
                                            by Systemic Injection in the Mouse            Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-125                 ...................  ASTM F749-98 (Reapproved 2007)e1 Standard     Title, Extent of
                                            Practice for Evaluating Material Extracts     recognition, and
                                            by Intracutaneous Injection in the Rabbit     Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-126                 ...................  ASTM F748-06 Standard Practice for Selecting  Extent of recognition
                                            Generic Biological Test Methods for           and Relevant guidance
                                            Materials and Devices
----------------------------------------------------------------------------------------------------------------
2-133                 ...................  ASTM F1408-97 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for Subcutaneous Screening Test
                                            for Implant Materials
----------------------------------------------------------------------------------------------------------------
2-134                 ...................  ASTM F2065-00 (Reapproved 2006) Standard      Extent of recognition
                                            Practice for Testing for Alternative
                                            Pathway Complement Activation in Serum by
                                            Solid Materials
----------------------------------------------------------------------------------------------------------------
2-135                 ...................  ANSI/ AAMI/ ISO 10993-12:2007 Biological      Title, Extent of
                                            Evaluation of Medical Devices--Part 12:       recognition, and
                                            Sample Preparation and Reference Materials    Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-136                 ...................  ASTM E1262-88 (Reapproved 2008) Standard      Title, Extent of
                                            Guide for Performance of Chinese Hamster      recognition, and
                                            Ovary Cell/Hypoxanthine Guanine               Relevant guidance
                                            Phosphoribosyl Transferase Gene Mutation
                                            Assay
----------------------------------------------------------------------------------------------------------------
2-137                 ...................  ASTM E1263-97 (Reapproved 2008) Standard      Extent of recognition
                                            Guide for Conduct of Micronucleus Assays in
                                            Mammalian Bone Marrow Erythrocytes
----------------------------------------------------------------------------------------------------------------
2-138                 ...................  ASTM E1280-97 (Reapproved 2008) Standard      Extent of recognition
                                            Guide for Performing the Mouse Lymphoma       and Relevant guidance
                                            Assay for Mammalian Cell Mutagenicity
----------------------------------------------------------------------------------------------------------------
2-139                 ...................  ASTM E1397-91 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for the In Vitro Rat Hepatocyte
                                            DNA Repair Assay
----------------------------------------------------------------------------------------------------------------

2-140                 ...................  ASTM E1398-91 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for the In Vivo Rat Hepatocyte DNA
                                            Repair Assay
----------------------------------------------------------------------------------------------------------------
2-141                 ...................  ASTM F1984-99 (Reapproved 2008) Standard      Extent of recognition,
                                            Practice for Testing for Whole Complement     Relevant guidance and
                                            Activation in Serum by Solid Materials        Contact person
----------------------------------------------------------------------------------------------------------------
2-142                 ...................  ASTM F1983-99 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for Assessment of Compatibility of
                                            Absorbable/Resorbable Biomaterials for
                                            Implant Applications
----------------------------------------------------------------------------------------------------------------
2-143                 ...................  ASTM F1904-98 (Reapproved 2008) Standard      Extent of recognition
                                            Practice for Testing the Biological
                                            Responses to Particles in vivo
----------------------------------------------------------------------------------------------------------------
2-144                 ...................  ASTM F619-03 (Reapproved 2008) Standard       Extent of recognition
                                            Practice for Extraction of Medical Plastics   and Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-145                 ...................  ASTM F1439-03 (Reapproved 2008) Standard      Extent of recognition
                                            Guide for Performance of Lifetime Bioassay
                                            for the Tumorigenic Potential of Implant
                                            Materials
----------------------------------------------------------------------------------------------------------------
2-146                 ...................  ASTM F2148-07e1 Standard Practice for         Extent of recognition
                                            Evaluation of Delayed Contact                 and Relevant guidance
                                            Hypersensitivity Using the Murine Local
                                            Lymph Node Assay (LLNA)
----------------------------------------------------------------------------------------------------------------
2-147                 ...................  USP 32-NF26 Biological Tests <87> 2009        Extent of recognition
                                            Biological Reactivity Test, In Vitro--        and Relevant guidance
                                            Direct Contact Test
----------------------------------------------------------------------------------------------------------------
2-148                 ...................  USP 32-NF26 Biological Tests <87> Biological  Extent of recognition
                                            Reactivity Test, In Vitro--Elution Test       and Relevant guidance
----------------------------------------------------------------------------------------------------------------
2-149                 ...................  USP 32-NF26 Biological Tests <88> Biological  Extent of recognition
                                            Reactivity Tests, In Vivo, Procedure--        and Relevant guidance
                                            Preparation of Sample
----------------------------------------------------------------------------------------------------------------
2-150                 ...................  USP 32-NF26 Biological Tests <88> Biological  Extent of recognition
                                            Reactivity Tests, In Vivo, Classification     and Relevant guidance
                                            of Plastics--Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
2-151                 ...................  USP 32-NF26 Biological Tests <88> Biological  Extent of recognition
                                            Reactivity Tests, In Vivo, Classification     and Relevant guidance
                                            of Plastics--Systemic Injection Test
----------------------------------------------------------------------------------------------------------------
2-152                 ...................  ISO 10993-10:2002/Amd.1:2006(E) Biological    Extent of recognition
                                            Evaluation of Medical Devices--Part 10:       and Relevant guidance
                                            Tests for Irritation and Delayed-Type
                                            Hypersensitivity AMENDMENT 1
----------------------------------------------------------------------------------------------------------------
B. Cardiology
----------------------------------------------------------------------------------------------------------------
3-2                   3-72                 ANSI/AAMI EC53:1995/(R) 2008 ECG Cables and   Withdrawn and replaced
                                            Leadwires                                     with newer version
----------------------------------------------------------------------------------------------------------------
3-29                  ...................  IEC 60601-2-30 (1999-12) Medical Electrical   Withdrawn
                                            Equipment, Part 2: Particular Requirements
                                            for the Safety, Including Essential
                                            Performance, of Automatic Cycling Non-
                                            Invasive Blood Pressure Monitoring
                                            Equipment
----------------------------------------------------------------------------------------------------------------
3-45                  3-73                 ANSI/AAMI/ISO EC57:1998/(R)2008 Testing and   Withdrawn and replaced
                                            Reporting Performance Results of Cardiac      with newer version
                                            Rhythm and ST-Segment Measurement
                                            Algorithms
----------------------------------------------------------------------------------------------------------------
3-49                  3-74                 ASTM F2079-02 (Reapproved 2008) Standard      Withdrawn and replaced
                                            Test Method for Measuring Intrinsic Elastic   with newer version
                                            Recoil of Balloon-Expandable Stents\1\
----------------------------------------------------------------------------------------------------------------
3-50                  ...................  AAMI/ANSI DF2-1996 (Revision of ANSI/AAMI     Withdrawn
                                            DF2-1989) Cardiac Defibrillator Devices
----------------------------------------------------------------------------------------------------------------
3-51                  ...................  AAMI /ANSI DF-39-1993 Automatic External      Withdrawn
                                            Defibrillators and Remote-Control
                                            Defibrillators
----------------------------------------------------------------------------------------------------------------
3-53                  3-75                 ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI       Withdrawn and replaced
                                            SP10:2002/A1:2003/(R)2008 & ANSI/AAMI         with newer version
                                            SP10:2002/A2:2006/(R)2008, ANSI/AAMI
                                            SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/
                                            A1:2003/(R)2008 & ANSI/AAMI SP10:2002/
                                            A2:2006/(R)2008 Manual, Electronic, or
                                            Automated Sphygmomanometers
----------------------------------------------------------------------------------------------------------------

3-63                  ...................  ISO 11318:2002 Cardiac Defibrillators--       Contact person
                                            Connector Assembly DF-1 for Implantable
                                            Defibrillators--Dimensions and Test
                                            Requirements
----------------------------------------------------------------------------------------------------------------
3-67                  3-76                 ASTM F2129-08 Standard Test Method for        Withdrawn and replaced
                                            Conducting Cyclic Potentiodynamic             with newer version
                                            Polarization Measurements to Determine the
                                            Corrosion Susceptibility of Small Implant
                                            Devices
----------------------------------------------------------------------------------------------------------------
3-70                  ...................  AAMI/ANSI SP10:2002/A1:2003--Amendment 1 to   Withdrawn
                                            ANSI/AAMI SP10:2002 Manual, Electronic, or
                                            Automated Sphygmomanometers
----------------------------------------------------------------------------------------------------------------
3-71                  ...................  AAMI/ANSI SP10:2002/A2:2006--Amendment 2 to   Withdrawn
                                            ANSI/AAMI SP10:2002 Manual, Electronic, or
                                            Automated Sphygmomanometers
----------------------------------------------------------------------------------------------------------------
C. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-78                  4-180                ISO 9168:2009 Dentistry--Hose Connectors for  Withdrawn and replaced
                                            Air Driven Dental Handpieces                  with newer version
----------------------------------------------------------------------------------------------------------------
4-87                  ...................  ADA/ANSI ADA Specification No. 69 - Dental    Reaffirmation
                                            Ceramic:1999
----------------------------------------------------------------------------------------------------------------
4-91                  ...................  ADA/ANSI ADA Specification No. 80 - Dental    Reaffirmation
                                            Material-Determination of Color
                                            Stability:2001
----------------------------------------------------------------------------------------------------------------
4-99                  4-181                ISO 4049:2009 Dentistry-Polymer-Based         Withdrawn and replaced
                                            Filling, Restorative and Luting Materials     with newer version
----------------------------------------------------------------------------------------------------------------
4-117                 ...................  ADA/ANSI Specification No. 12 - Denture Base  Reaffirmation
                                            Polymers:2002
----------------------------------------------------------------------------------------------------------------
4-119                 ...................  ADA/ANSI Specification No. 82 - Dental        Reaffirmation
                                            Reversible/Irreversible Hydrocolloid
                                            Impression Material Systems: 1998/
                                            Reaffirmed 2003
----------------------------------------------------------------------------------------------------------------
4-120                 4-182                ISO 10139-2:2009 Dentistry--Soft Lining       Withdrawn and replaced
                                            Materials for Removable Dentures--Part 2:     with newer version
                                            Materials for Long-Term Use
----------------------------------------------------------------------------------------------------------------
4-160                 ...................  ANSI/ASA S3.1-1999 (R 2003) Maximum           Reaffirmation
                                            Permissible Ambient Noise Levels for
                                            Audiometric Test Rooms
----------------------------------------------------------------------------------------------------------------
4-161                 4-183                ANSI/ASA S3.2-2009 Method for Measuring the   Withdrawn and replaced
                                            Intelligibility of Speech Over                with newer version
                                            Communication Systems
----------------------------------------------------------------------------------------------------------------
4-164                 ...................  ANSI/ASA S3.7-1995 (R 2003) Method for        Reaffirmation
                                            Coupler Calibration of Earphones
----------------------------------------------------------------------------------------------------------------
4-166                 ...................  ANSI/ASA S3.20-1995 (R2003) Bioacoustical     Reaffirmation
                                            Terminology
----------------------------------------------------------------------------------------------------------------
4-167                 ...................  ANSI/ASA S3.21-2004 Methods for Manual Pure-  Reaffirmation
                                            Tone threshold Audiometry
----------------------------------------------------------------------------------------------------------------
4-168                 4-184                ANSI/ASA S3.25-2009 Occluded Ear Simulator    Withdrawn and replaced
                                                                                with newer version
----------------------------------------------------------------------------------------------------------------
4-174                 4-185                ANSI/ASA S3.45-2009 Procedures for Testing    Withdrawn and replaced
                                            Basic Vestibular Function                     with newer version
----------------------------------------------------------------------------------------------------------------
4-176                 4-186                ANSI/ASA S12.2-2008 Criteria for Evaluating   Withdrawn and replaced
                                            Room Noise                                    with newer version
----------------------------------------------------------------------------------------------------------------
D. General
----------------------------------------------------------------------------------------------------------------
5-18                  5-51                 ASTM D-4332-01 (Reapproved 2006) Standard     Withdrawn and replaced
                                            Practice for Conditioning Containers,         with newer version
                                            Packages, or Packaging Components for
                                            Testing
----------------------------------------------------------------------------------------------------------------
5-29                  ...................  AAMI/ANSI HE74-2001/ Human Factors Design     Reaffirmation
                                            Process for Medical Devices
----------------------------------------------------------------------------------------------------------------
E. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-35                  7-205                CLSI H47-A2 One-Stage Prothrombin Time (PT)   Withdrawn and replaced
                                            Test and Activated Partial Thromboplastin     with newer version
                                            Time (APTT) Test
----------------------------------------------------------------------------------------------------------------

7-42                  7-206                CLSI I/LA20-A2 Analytical Performance         Withdrawn and replaced
                                            Characteristics and Clinical Utility of       with newer version
                                            Immunological Assays for Human
                                            Immunoglobulin E (IgE) Antibodies and
                                            Defined Allergen Specificities
----------------------------------------------------------------------------------------------------------------
7-97                  7-207                CLSI GP16-A3 Urinalysis                       Withdrawn and replaced
                                                                                with newer version
----------------------------------------------------------------------------------------------------------------
7-187                 7-208                CLSI M44-S2 Zone Diameter Interpretive        Withdrawn and replaced
                                            Standards, Corresponding Minimal Inhibitory   with newer version
                                            Concentration (MIC) Interpretive
                                            Breakpoints, and Quality Control Limits for
                                            Antifungal Disk Diffusion Susceptibility
                                            Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-37                  ...................  NCCLS I/LA06-A Detection and Quantitation of  Withdrawn
                                            Rubella IgG Antibody: Evaluation and
                                            Performance Criteria for Multiple Component
                                            Test Products, Specimen Handling, and Use
                                            of Test Products in the Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
F. Materials
----------------------------------------------------------------------------------------------------------------
8-104                 8-189                ASTM F 1108--04 (Reapproved 2009) Standard    Withdrawn and replaced
                                            Specification for Titanium-6Aluminum-         with newer version
                                            4Vanadium Alloy Castings for Surgical
                                            Implants (UNS R56406)
----------------------------------------------------------------------------------------------------------------
8-145                 8-190                ASTM F 90-09 Standard Specification for       Withdrawn and replaced
                                            Wrought Cobalt-20Chromium-15Tungsten-         with newer version
                                            10Nickel Alloy for Surgical Implant
                                            Applications (UNS R30605)
----------------------------------------------------------------------------------------------------------------
G. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-19                 16-162               ISO 7176-4:2008 Wheelchairs--Part 4: Energy   Withdrawn and replaced
                                            Consumption of Electric Wheelchairs and       with newer version
                                            Scooters for Determination of Theoretical
                                            Distance Range
----------------------------------------------------------------------------------------------------------------
16-20                 16-163               ISO 7176-5:2008 Wheelchairs--Part 5:          Withdrawn and replaced
                                            Determination of Dimensions, Mass and         with newer version
                                            Manoeuvring Space
----------------------------------------------------------------------------------------------------------------
16-23                 16-164               ISO 7176-10:2008 Wheelchairs--Part 10:        Withdrawn and replaced
                                            Determination of Obstacle-Climbing Ability    with newer version
                                            of Electrically Powered Wheelchairs
----------------------------------------------------------------------------------------------------------------
16-26                 16-165               ISO 7176-14:2008 Wheelchairs--Part 14 Power   Withdrawn and replaced
                                            and Control Systems for Electrically          with newer version
                                            Powered Wheelchairs and Scooters--
                                            Requirements and Test Methods
----------------------------------------------------------------------------------------------------------------
H. Sterility
----------------------------------------------------------------------------------------------------------------
14-117                ...................  ANSI/AAMI ST35:2003 Handling and Biological   Withdrawn
                                            Decontamination of Reusable Medical Devices
                                            in Health Care Facilities and in
                                            Nonclinical Settings
----------------------------------------------------------------------------------------------------------------
14-263                14-280               ANSI/AAMI ST79:2006 and A1:2008, A2:2009      Withdrawn and replaced
                                            (Consolidated Text) Comprehensive Guide to    with newer version
                                            Steam Sterilization and Sterility Assurance
                                            in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
14-256                14-286               ASTM F2095-07e1 Standard Test Methods for     Withdrawn and replaced
                                            Pressure Decay Leak Test for Flexible         with newer version
                                            Packages With and Without Restraining
                                            Plates
----------------------------------------------------------------------------------------------------------------
14-255                14-281               ASTM F17-08 Standard Terminology Relating to  Withdrawn and replaced
                                            Flexible Barrier Packaging\1\                 with newer version
----------------------------------------------------------------------------------------------------------------
14-245                14-282               ASTM F2338-09 Standard Test Method for        Withdrawn and replaced
                                            Nondestructive Detection of Leaks in          with newer version
                                            Packages by Vacuum Decay Method\1\
----------------------------------------------------------------------------------------------------------------
14-237                14-283               ASTM F 88/F 88M--09 Standard Test Method for  Withdrawn and replaced
                                            Seal Strength of Flexible Barrier             with newer version
                                            Materials\1\
----------------------------------------------------------------------------------------------------------------
14-199                14-284               ASTM D4169-08 Standard Practice for           Withdrawn and replaced
                                            Performance Testing of Shipping Containers    with newer version
                                            and Systems\1\
----------------------------------------------------------------------------------------------------------------
14-228                ...................  ANSI/AAMI/ISO 11135-1:2007 Sterilization of   Guidance
                                            Health Care Products - Ethylene oxide -
                                            Part 1: Requirements for Development,
                                            Validation, and Routine Control of a
                                            Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------

14-70                 14-285               ANSI/AAMI/ISO 14161:2009 Sterilization of     Withdrawn and replaced
                                            Health Care Products - Biological             with newer version
                                            Indicators - Guidance for the Selection,
                                            Use and Interpretation of Results
----------------------------------------------------------------------------------------------------------------
I. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-6                  15-16                ASTM F2450-09 Standard Guide for Assessing    Withdrawn and replaced
                                            Microstructure of Polymeric Scaffolds for     with newer version
                                            Use in Tissue Engineered Medical
                                            Products\1\
----------------------------------------------------------------------------------------------------------------
15-9                  15-17                ASTM F2311-08 Standard Guide for              Withdrawn and replaced
                                            Classification of Therapeutic Skin            with newer version
                                            Substitutes\1\
----------------------------------------------------------------------------------------------------------------
15-13                 15-18                ASTM F2212-09 Standard Guide for              Withdrawn and replaced
                                            Characterization of Type I Collagen as        with newer version
                                            Starting Material for Surgical Implants and
                                            Substrates for Tissue Engineered Medical
                                            Products (TEMPs)\1\
----------------------------------------------------------------------------------------------------------------

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 023.

        Table 3.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                         Reference No. &
Recognition No.            Title of Standard                  Date
------------------------------------------------------------------------
A. Cardiology
------------------------------------------------------------------------
3-77             Active Implantable Medical Devices--   ANSI/AAMI
                  Electromagnetic Compatibility--EMC     PC69:2007
                  Test Protocols for Implantable
                  Cardiac Pacemakers and Implantable
                  Cardioverter Defibrillators
------------------------------------------------------------------------
B. In Vitro Diagnostics
------------------------------------------------------------------------
7-209            Performance Metrics for Continuous     POCT 05-A
                  Interstitial Glucose Monitoring
------------------------------------------------------------------------
C. Orthopedics
------------------------------------------------------------------------
11-219           Standard Specification for             ASTM F 2026-08
                  Polyetheretherketone (PEEK) Polymers
                  for Surgical Implant Applications
------------------------------------------------------------------------
D. Physical Medicine
------------------------------------------------------------------------
16-166           Wheelchairs--Requirements and Test     ISO 7176-21:2009
                  Methods for Electromagnetic
                  Compatibility of Electrically
                  Powered Wheelchairs and Scooters,
                  and Battery Chargers
------------------------------------------------------------------------
E. Sterility
------------------------------------------------------------------------
14-286           Processing of Reusable Surgical        ANSI/AAMI
                  Textiles for Use in Health Care        ST65:2008
                  Facilities
------------------------------------------------------------------------

IV. List of Recognized Standards

    FDA maintains the agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this notice into the database and,
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (See FOR FURTHER INFORMATION CONTACT). To be
properly considered such recommendations should contain, at a minimum,
the following information: (1) title of the standard; (2) any reference
number and date; (3) name and address of the national or international
standards development organization; (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply; and (5) a brief identification of the testing or performance or
other characteristics of the devices that would be addressed by a
declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal

computer with access to the Internet. Updated on a regular basis, the
CDRH home page includes the guidance as well as the current list of
recognized standards and other standards related documents. After
publication in the Federal Register, this notice announcing
``Modification to the List of Recognized Standards, Recognition List
Number: 023'' will be available on the CDRH home page. You may access
the CDRH home page at http://www.fda.gov/cdrh.
    You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/
stdsprog.html.
    This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/
cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Two copies of any mailed comments are to be submitted,
except that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. FDA will consider any comments received in determining
whether to amend the current listing of modifications to the list of
recognized standards, Recognition List Number: 023. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.

    Dated: April 30, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10562 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S


MEMORANDUM

SUBJECT: 	Technical Support Document for Approval of a Missouri State Implementation Plan Revision relating to Restriction of Particulate Matter to the Ambient Air Beyond the Premises of Origin

FROM: 		Steven Brown
                  ARD/APPB/APS

TO: 			EPA-R07-OAR-2023-0193; MO-422

THROUGH:  	Amy Algoe-Eakin, Branch Supervisor
                  ARD/APPB

SUMMARY:
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Missouri State Implementation Plan (SIP) received from the Missouri Department of Natural Resources (MoDNR) as a SIP revision submission on March 7, 2019.

Specifically, the revisions are to the existing rule, Title 10, Division 10 of the Code of State Regulations, (10 CSR 10-6.170) "Restriction of Particulate Matter to the Ambient Air Beyond the Premises of Origin", with a restructured version of the same rule. The rule was SIP approved in 40 CFR § 52.1320(c) on May 1, 2000 (65 FR 17164). The purpose of the state regulation is to restrict particulate matter to the ambient air beyond the premises of origin.

These proposed revisions restructure the rule to the MoDNR standard rule organizational format, add definitions specific to this rule and removes unnecessary words.

RULE REVISIONS:
Below is EPA's description of the changes made to each rule section and the text of the revised rule.
Revisions that are additions to MoDNR's existing approved SIP rule text are bold. Revisions that are deletions to the existing approved SIP rule text are stricken through. The rule text with changes is listed first and is followed by a summary of the EPA's review of the changes. In some sections there may be an EPA notation at the beginning of the section explaining rearrangement of language.

10 CSR 10-6.170 Restriction of Particulate Matter to the Ambient Air
 Beyond the Premises of Origin

     Restrictions to Limit Fugitive Particulate Matter Emissions. It shall be a violation of this regulation if, in the opinion of the staff director --

(A) Any person causes or allows to occur any handling, transporting or storing of any material; construction, repair, cleaning or demolition of a building or its appurtenances; construction or use of a road, driveway or open area; or operation of a commercial or industrial installation without applying reasonable measures as may be required to prevent, or in a manner which allows or may allow, fugitive particulate matter emissions to go beyond the premises of origin in quantities that the particulate matter may be found on surfaces beyond the property line of origin. The nature or origin of the particulate matter shall be determined to a reasonable degree of certainty by a technique proven to be accurate and approved by the
director; or

(B) Any person causes or allows to occur any fugitive particulate
matter emissions to remain visible in the ambient air beyond the
property line of origin.

EPA Analysis:  The revisions to section (1), (1)(A) and (1)(B) are administrative in nature and do not affect the stringency of the SIP.

Section 1. (A): This revision moves the language to section (3) "General Provisions" under subsection (A)1. and subsection (A)2. and  removes unnecessary words.

Section 1. (B):  This revision moves the language to section (3) "General Provisions" subsection (A)1B. and removes unnecessary words.

Note: At the bottom of this TSD, you can find the completed revised version of this rule in bold text.

Rule continues-

 (2) Should the director determine that noncompliance with section
 (1) has occurred at a location, the director may require reasonable control measures, as may be necessary. These measures may include, but are not limited, to the following:

 Revision of procedures involving construction, repair, cleaning and demolition of buildings and their appurtenances that produce particulate matter emissions;

 Paving or frequent cleaning of roads, driveways and parking

 lots;

      C.  Application of dust free surfaces;

      D.  Application of water; and

      E.  Planting and maintenance of vegetative ground cover.

EPA Analysis:  The revisions to section (2)(A)(B)(C)(D)(E) are administrative in nature and do not affect the stringency of the SIP.

Section (2) (A)(B)(C)(D)(E): This revision moves the unchanged language to Section (3) "General Provisions" under subsection (B) 1, 2, 3, 4, 5.

Note: At the bottom of this TSD, you can find the completed revised version of this rule in bold text.

Rule continues-

(3) Exceptions. Section (1) shall not apply to the following:

(A) Those portions of unpaved public roads that are not designated as nonattainment areas for
particulate matter;

(B) Agricultural operations including tilling, planting, cultivating or harvesting within a field,
the moving of livestock on foot or the hauling of produce within the confines of a farm; and

(C) Driveways limited to residential use.

EPA Analysis:  The revisions to the "Exemptions" section (3)(A)(B)(C) are administrative in nature and do not affect the stringency of the SIP.

Section (3) (A)(B)(C): This revision moves the unchanged language to Section (1) "Applicability" under subsection (A)(B)(C).

Note: At the bottom of this TSD, you can find the completed revised version of this rule in bold text.

Rule continues-

(4) The staff director may allow an exemption for unusual and
adverse weather conditions for any activity which would otherwise be
a violation of section (1). These conditions may include, but are not
limited to, high winds, extended dry weather periods and extreme cold
weather periods.
(D) Fugitive PM emissions in violation of this rule which, according
to the director, occurred due to unusual or adverse weather
conditions. These conditions may include, but are not limited to,
high winds, extended dry weather periods, and extreme cold weather
periods.

EPA Analysis:  The revisions to section (4) are administrative in nature and do not affect the stringency of the SIP.  See below for explanation of changes.

Section (4): This revision rewrites the paragraph and moves the language to Section (1) "Applicability" under subsection (D). The revisions do not substantively change the language from the previous Section (4). Therefore, the intent of the paragraph remains unchanged.

Note: At the bottom of this TSD, you can find the completed revised version of this rule in bold text.

Rule continues-

EPA Note: See below in bold text Missouri's completed version of the structural,  organizational and wording changes to this rule. Please see that Section 2 has been created as the "Definitions" section and adds six definitions that are specific to this rule. Over the years, MoDNR has gone away from referencing definitions within Missouri's state rules and have been adding the definitions to each rule as they are revised and/or created.

(1) Applicability. This rule applies to any operation, process, or
activity resulting in fugitive particulate matter (PM) emissions
throughout the state of Missouri, with the following exceptions:

(A) Fugitive PM emissions from unpaved public roads located in areas
not designated as nonattainment for PM;

(B) Agricultural operations including tilling, planting, cultivating
or harvesting within a field, the moving of livestock on foot, or the
hauling of produce within the confines of a farm;

(C) Fugitive PM emissions from driveways limited to residential use;
and

(D) Fugitive PM emissions in violation of this rule which, according
to the director, occurred due to unusual or adverse weather
conditions. These conditions may include, but are not limited to,
high winds, extended dry weather periods, and extreme cold weather
periods.

(2) Definitions.

(A) Control measure -- Any means which reduce the quantity of a
pollutant that is emitted into the air.

(B) Director -- Director of the Missouri Department of Natural
Resources or a representative designated to carry out the duties as
described in 643.060, RSMo.

(C) Facility -- All contiguous or adjoining property that is under
common ownership or control, including properties that are separated
only by a road or other public right-of-way.

(D) Fugitive particulate matter emissions -- Any particulate matter
emissions which could not reasonably be passed through a stack,
chimney, vent, or other functionally equivalent opening.

(E) Nonattainment area (NAA) -- Any geographic area of the United
States which has been designated as nonattainment under section 107
of the Clean Air Act and described in 40 CFR 81.

(F) Particulate matter -- Any liquid or solid material, except
uncombined water, that exists in a finely divided form with an
aerodynamic diameter smaller than one hundred micrometers (100 μm).

(3) General Provisions.

(A) Restrictions to Limit Fugitive Particulate Matter Emissions.

     1. No person shall cause or allow fugitive particulate matter
emissions to --

        A. Go beyond the premises of origin in such quantities
that the particulate matter may be found on surfaces beyond the
property line of origin due to the following activities:

          (I) Handling, transporting, or storing of any
material;

          (II) Construction, repair, cleaning, or demolition of
a building or its appurtenances;

          (III) Construction or use of a road, driveway, or open
area; or

          (IV) Operation of a commercial or industrial facility;
or

        B. Remain visible in the ambient air beyond the property
line of origin.

     2. The nature or origin of the particulate matter shall be
determined to a reasonable degree of certainty by a technique proven
to be accurate and approved by the director.

(B) Should the director determine that noncompliance with subsection
(3)(A) has occurred at a location, the director may require
reasonable control measures, as may be necessary. These measures may
include, but are not limited to, the following:

     1. Revision of procedures involving construction, repair,
cleaning, and demolition of buildings and their appurtenances that
produce particulate matter emissions;

     2. Paving or frequent cleaning of roads, driveways, and
parking lots;

     3. Application of dust-free surfaces;

     4. Application of water; and

     5. Planting and maintenance of vegetative ground cover.

(4) Reporting and Record Keeping. (Not Applicable)

(5) Test Methods. (Not Applicable)


COMPANY FEDERAL REGISTER DOCUMENT SUBMISSION TEMPLATE (7/1/2006)

EPA Registration Division contact: [insert name and telephone number
with area code]

INSTRUCTIONS:  Please utilize this outline in preparing tolerance
petition documents.  In cases where the outline element does not apply
please insert “NA-Remove” and maintain the outline.  The comment
notes that appear on the left margin represent hidden typesetting codes
designed to expedite the processing of the Federal Register document.
Please do not remove or alter these comment notes or change the margins,
font, or format in your document. Simply replace the instructions that
appear in italics and brackets, i.e., “[insert company name],” with
the information specific to your action.]

TEMPLATE:

[BASF Corporation]

[PP 5E6996]

	EPA has received an amendment to pesticide petition ([PP5E6996]) from
[BASF Corporation], [100 Campus Drive, Florham Park, NJ 07932]
proposing, pursuant to section 408(d) of the Federal Food, Drug, and
Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part 180.

(Options (pick one)

	2. to establish an exemption from the requirement of a tolerance for

	[Vitamin E (CAS no. 1406-18-4) in the form of Vitamin E Alcohol
(d-alpha tocopherol, CAS no. 59-02-9 and dl-alpha tocopherol, CAS no.
10191-41-0) and Vitamin E Acetate (d-alpha tocopheryl acetate, CAS no.
58-95-7 and dl-alpha tocopheryl acetate, CAS no. 7695-91-2)] in or on
raw agricultural commodities when used as an ingredient in pesticide
formulations used in accordance with good agricultural practices.
[Vitamin E is a chemical complex that includes eight naturally occurring
homologues having a chromanol ring and a twelve-carbon aliphatic side
chain containing two methyl groups in the middle and two or more methyl
groups on the end.  Vitamin E is found in many plant-derived foods and
is believed to be necessary for human health.  Vitamin E alcohol in the
form of d-alpha tocopherol has the highest biological activity of the
compounds in the Vitamin E complex.  Vitamin E alcohol and its ester,
Vitamin E acetate, are commonly consumed as dietary supplements.
Vitamin E alcohol and Vitamin E acetate are common food additives.
Vitamin E alcohol is used as an antioxidant for foods or food chemicals.
Vitamin E acetate is a common animal feed additive and is used widely in
topical skin care products.]  EPA has determined that the petition
contains data or information regarding the elements set forth in section
408 (d)(2) of the FDDCA; however, EPA has not fully evaluated the
sufficiency of the submitted data at this time or whether the data
supports granting of the petition. Additional data may be needed before
EPA rules on the petition.

A. Residue Chemistry

]

	3. Magnitude of residues. [Residues of Vitamin E were evaluated using
the EPA Tier I exposure level screening method, which is being used for
inert ingredients.  By the Tier I method, the maximum estimated chronic
exposures range from 0.087 mg/kg/day for adults to 0.422 mg/kg/day for
children ages one to two years.  Taking the chronic toxicity endpoint of
50 mg/kg/kay for adults (see toxicity data below), and using a safety
margin of 100, gives a calculated chronic population adjusted dose
(cPAD) of 17% for adults.  All other population subgroups give cPAD <100
except for children one to two years, where a chronic toxicity limit of
20 mg/kg/day gives a cPAD of 210%.  This subgroup therefore requires a
higher level of analysis.  The Tier I analysis assumes that the inert is
used at the same levels as active ingredients; in reality, the level of
Vitamin E use in a pesticide formulation would be far less than half
that of the typical active ingredient.  Therefore, the estimated
exposure can safely be reduced to less than 0.2 mg/kg/day for children
one to two years, giving a cPAD of <100%.

The estimated acute exposures at the 95th percentile of exposure range
from 0.199 mg/kg/day for adults to 0.939 mg/kg/day for children one to
two years.  An NOAEL for acute toxicity is not known, but the LD50 for
rats is >4,750 mg/kg.  Scaling this by 100 to estimate for humans, and
using a safety margin of 100 gives an acute PAD (aPAD) of 42% for
adults.  For children one to two years, this gives an aPAD of 198%.
Using similar rationale as with the cPAD analysis, the aPAD calculated
with a more realistic formulation use level would be <100% for all
population subgroups.

]

B. Toxicological Profile

Vitamin E in supplements is usually consumed as alpha-tocopheryl
acetate, a more stable form.  The body converts the esters to
tocopherols. Therefore, toxicology data presented for alpha-tocopherol
can be reliably bridged to alpha-tocopheryl acetate and vice versa.

Alpha-tocopherol and mixed tocopherol concentrate were evaluated for
acceptable daily intake at the sixth and seventeenth meetings of the
Joint FAO/WHO Expert Committee on Food Additives.  These evaluations are
summarized in the sections that follow.

	Alpha-tocopherol may be an essential nutrient.  The Institute of
Medicine, Food and Nutrition Board has published recommended daily
allowances (RDAs) and Tolerable Upper Intake Levels (ULs), listed below.
 A Joint FAO/WHO expert consultation report, Human Vitamin and Mineral
Requirements, was published in 2002, covering the 1998 consultation in
Bangkok.  It describes the difficulty in determining Recommended
Nutrient Intake (RNI) levels for vitamin E, but states that vitamin E
appears to have very low toxicity, with 100 to 200 mg/day of the
synthetic (dl-alpha-tocopherol) commonly taken as dietary supplements.
They note that pro-oxidant damage has been associated with feeding of
vitamin E supplements, but typically only at very high levels, e.g.,
exceeding 1,000 mg/day.

]

	2. Genotoxicty. [According to the Joint FAO/WHO committee reports,
alpha-tocopherol was nonmutagenic.  Ames salmonella assay: Not mutagenic
(BASF MSDS).]

	3. Reproductive and developmental toxicity. [According to the Joint
FAO/WHO committee reports, the results of reproduction/teratology
studies did not indicate that alpha-tocopherol had adverse effects on
reproductive function.  90-day study on d-alpha-tocopherol polyethylene
glycol 1000 succinate (TPGS), a water-soluble form of vitamin E:
Reproductive indices (mean gestation period, litter size, sex ratio, and
mortality of pups or parents) were unaffected by treatment.  Clinical
chemical and hematological parameters were normal in the Fo generation
10 days before terminal sacrifice.]

	4. Subchronic toxicity. [From The European Commission, Opinion of the
Scientific Committee on Food on the Tolerable Upper Intake Level of
Vitamin E, April 4th 2003:  In rats given alpha-tocopheryl acetate by
gavage at doses of 125 to 2,000 mg/kg bw/day, TSH levels were elevated
by 30 to 100%.  At a dose of about 100 mg/kg bw/day, biochemical indices
of hepatotoxicity (serum alkaline phosphatase, alanine aminotransferase,
and aspartate aminotransferase) were elevated and liver weight was
increased.  The NOAEL for these effects was 125 mg alpha-tocopherol
acetate/ kg body weight (Abdo et al., 1986).]

	5. Chronic toxicity. [Ingestion of large amounts of alpha-tocopherol
over long periods of time may cause gastrointestinal distress, muscle
weakness, and fatigue.  The following is reported in the FAO/WHO report
(complete references are listed in the original summary report):

Rats

Groups of weanling female Wistar rates were fed diets containing 0; 25;
250; 2,500; 10,000; or 25,000 IU vitamin E/kg diet for eight and 16
months. [1 IU=0.67 mg alpha-tocopherol].  Vitamin E depressed
body-weight gain at concentrations of 10,000 and 25,000 IU/kg diet, and
increased relative heart and spleen weights were seen at eight months
and 16 months, respectively.  There was an increase in plasma alkaline
phosphatase and a decrease in the ash content of bone after 16 months at
these two dose levels.  Prothrombin time was reduced at 12 months, but
not at nine or 16 months.  Urinary excretion of creatine and creatinine
was normal at 11 months.  No histological examinations were reported
(Yang & Desai, 1977).

Groups of 60 male and 60 female Charles River CD rats, initial body
weight 134 g (males) or 130 g (females), were fed a diet supplemented
with dl-alpha-tocopheryl acetate at levels calculated to give a dose of
500; 1,000; or 2,000 mg/kg bw/day.  Occasional difficulties in arresting
bleeding were observed when blood samples were collected after eight
weeks and frank hemorrhages were observed in males only from week 15
(high-dose), week 16 (intermediate-dose), or week 18 (low-dose).
Hemorrhages occurred variously in the gut, urinary tract, orbit and
meninges, and from minor injuries to the claws or vibrissal pits.
Vitamin K supplementation was effective in bringing about recovery
within one to three days.  In all other respects, the appearance and
behavior of treated animals were similar to controls, and food
consumption and body-weight gain were similar to or slightly greater
than controls.

Mortality due to hemorrhage in males during the first 26 weeks,
maximally 10% in the high-dose group, was balanced by a similar number
of deaths in control males between weeks 26 and 52, and thereafter
alpha-tocopherol did not adversely affect survival.  At termination,
there were no significant differences in mortality between any treatment
groups of either sex and their respective controls.  Prothrombin times
were prolonged in males of all treatment groups at week four until week
13, but these returned to normal by week 26 (after initiation of vitamin
K supplementation in week 24); females were unaffected.  No other
hematological differences between treated and control animals were seen
except for a transient, slight lowering of the hematocrit and hemoglobin
at week eight in both males and females in the highest dose group.
Serum alkaline phosphatase was occasionally significantly elevated
(p<0.05) in the high-dose group, but the differences were not consistent
nor progressive with time; no such changes were seen at lower-dose
levels.  A dose-related elevation of alanine aminotransferase was
observed in treated males at week four, persisting to week 26, but later
it lost statistical significance.  Aspartate aminotransferase and all
other blood chemical parameters were unaffected, and not significant
changes were seen on urinalysis.

At necropsy, no macroscopic changes related to treatment were observed.
 In females (but not males) of the high-dose group, a slightly elevated
absolute liver weight was seen at the interim sacrifice, but the
relative liver weight was not increased and no significant differences
in relative or absolute organ weights were seen at termination of the
study.  Histopathological examination of the livers did not reveal any
treatment-related changes with the exception of agglomerations of
vacuolated (“foamy”) macrophages in the centriacini of some treated
rats, distributed among the treated rats without dose-relation, but
never occurring in controls.  The foamy macrophages stained strongly
with periodic acid schiffs (PAS) and Oil Red O, which distinguished them
from occasional peribiliary macrophages seen in controls; they were seen
in 17% of treated males and 77% of treated females across the study as a
whole.  No other treatment-related effects were observed.  Whether
considered separately by tumor type, or in aggregate, the tumor
incidence did not reveal any neoplastic effects of treatment.  In both
sexes, there were indications of an inverse relationship between dosage
and incidence of mammary fibroadenomas, but this effect was
statistically significant only in females (Wheldon et al., 1983).

Humans

Adult humans have tolerated 1 g per day alpha-tocopherol for months or
larger doses for shorter periods with no undesirable effects.
Therapeutically, daily doses of 20 to 600 mg of alpha-tocopherol or its
acetate salt are often taken with no toxic effects (Finkler, 1949;
McLaren, 1949; Sebrell & Harris, 1954).

The clinical literature contains references to complaints of gastric
distress and other symptoms in patients receiving much smaller dosages;
these symptoms are probably attributable to fatty substances present in
alpha-tocopherol concentrates or, in some instances, to psychic factors
(Sebrell & Harris, 1954).

Side effects reported in clinical use of vitamin E supplements include
severe weakness and fatigue induced in healthy adults by daily doses of
around 720 mg alpha-tocopherol (Cohen, 1973a, b).  These side effects
were observed in a double-blind study on two healthy young males
receiving 720 mg alpha-tocopherol daily (Briggs, 1974; Briggs & Briggs,
1974).  In the latter study, the symptoms were associated with an
increase in serum creatine kinase activity and greatly increased 24-hour
urinary creatine excretion; asymptomatic creatinuria was reported in a
young male taking high doses of vitamin E (Hillman, 1957).

A 55 year-old patient presented with ecchymoses and prolonged
prothrombin time after self-administration of a vitamin E preparation at
up to 1,200 IU/day for two months while receiving warfarin and
clofibrate therapeutically.  The prothrombin time returned to its
baseline value after vitamin E administration was stopped while warfarin
and clofibrate treatment continued.  In a subsequent challenge study,
vitamin E (90% alpha-tocopherol) was given for seven weeks at a daily
dose of 800 IU/day; at the same time the patient received his normal
medication of digoxin (0.25 mg/day), sodium warfarin (5 mg/day
alternating with 2.5 mg/day), clofibrate (500 mg four times a day), and
procainamide (500 mg four times a day).  By the fourth week the
prothrombin time was increased from an initial value of 20.7 seconds to
24 seconds and continued to increase to 29.2 seconds after seven weeks;
levels of Factors II, VIII, IX, and X were depressed.  At this time,
multiple ecchymoses and a small hematoma were evident, so vitamin E was
discontinued.  The prothrombin time and levels of clotting factors
returned to baseline values within seven days and clinical signs of
hemorrhage disappeared (Corrigan & Marcus, 1974).

The hematological response to iron therapy by children with
iron-deficiency anemia has been reported to be significantly impaired if
vitamin E supplements are given simultaneously (Melhorne & Gross, 1969).

Allergic reactions shown by some individuals to topical creams or sprays
containing vitamin E were shown by patch tests to be due to
alpha-tocopherol (Brodkin & Bleiberg, 1965; Minkin et al., 1973; Aeling
et al., 1973).

Skin rashes and gastrointestinal irritation were reported in early
studies of oral vitamin E supplementation in the form of wheat-germ oil,
but it is not known whether this was due to alpha-tocopherol (Shute,
1938).

Effects of alpha-tocopherol on some biochemical parameters have been
reported in man.  A group of 52 patients (average age 72 years) showed a
mean increase in serum cholesterol of 74 mg/dl while receiving 300 mg
alpha-tocopherol daily (Dahl, 1974), but no such increase was seen in a
small group of healthy young men taking 800 mg daily (Briggs, 1974;
Briggs & Briggs, 1974).

When patients with porphyria cutanea tarda were given daily doses of
1,000 mg alpha-tocopherol for three months, there were marked increases
in 24-hour urinary excretion of androsterone and etiocholanone +
dehydroepiandrosterone and a large decrease in 24-hour excretion of
pregnanediol (Pinelli et al., 1972).

The Institute of Medicine, Food and Nutrition Board has determined the
following Tolerable Upper Intake Levels (UL) values for
alpha-tocopherol, reported in mg of alpha-tocopherol equivalents (ATEs):

Table 1: ULs for alpha-tocopherol.

Age (years)

Males

 (mg/day)

Females

(mg/day)

Pregnancy (mg/day)

Lactation (mg/day)

1-3

200 (=300 IU)

200 (=300 IU)

N/A

N/A

4-8

300 (=450 IU)

300 (=450 IU)

N/A

N/A

9-13

600 (=900 IU)

600 (=900 IU)

N/A

N/A

14-18

800 (=1,200 IU)

800 (=1,200 IU)

800 (=1,200 IU)

800 (=1,200 IU)

19-70

1,000 (=1,500 IU)

1,000 (=1,500 IU)

1,000 (=1,500 IU)

1,000 (=1,500 IU)

>70

200 (=300 IU)

200 (=300 IU)

N/A

N/A

	6. Animal metabolism. [When rats were given 3.5 mg alpha-tocopherol
daily by mouth, three to 15% appeared in the feces.  With larger doses,
up to 25% appeared in the feces.  There is practically no urinary
excretion of tocopherol but, from studies with labeled material, it
appeared that one or more metabolites of tocopherol are excreted in the
urine.  When more than the daily requirement is administered, there is
some storage of tocopherol in the liver.  The major pathway of
tocopherol metabolism is via phytyl side chain oxidation, leaving
carboxyethylhydroxychromans (CEHC) as metabolites.  Tocopheryl quinone
is also formed in animal metabolism via oxidation, followed by
conjugation to the glucuronate, which is excreted in the bile or further
degraded in the kidneys to alpha-tocopheronic acid, which is then
excreted in bile (2002 Joint FAO/WHO expert consultation report, Human
Vitamin and Mineral Requirements).]

	7. Metabolite toxicology. [Alpha and gamma CEHC are water soluble,
renally excreted, with known potent anti-inflammatory and antioxidative
properties.  (Himmelfarb et al., Kidney International, Volume 64 Issue 3
Page 978; September 2003).]

	8. Endocrine disruption. [Based upon the available data,
alpha-tocopherol is not anticipated to disrupt the endocrine system.]

C. Aggregate Exposure

	1. Dietary exposure. [Various forms of vitamin E are present in many
foods and consumed as dietary supplements.  Exposure to vitamin E within
reasonable limits is considered beneficial.]

	i. Food. [Vegetable oils, nuts, green leafy vegetables, and fortified
cereals are common food sources of vitamin E in the US.  The NIH Office
of Dietary Supplements lists the following sample of foods providing
vitamin E (Table 2).  Food values are listed in alpha-tocopherol
equivalents (ATE) to account for the variation in biological activity of
the different forms of vitamin E.

Table 2: Selected Food Sources of vitamin E

FOOD

Milligrams (mg) Alpha-tocopherol pre serving

Percent DV*

Wheat germ oil, 1 tablespoon

20.3

100

Almonds, dry roasted, 1 oz

7.4

40

Sunflower seed kernels, dry roasted, 1 oz

6.0

30

Sunflower oil, over 60% linoleic, 1 tablespoon

5.6

30

Safflower oil, over 70% oleic, 1 tablespoon

4.6

25

Hazelnuts, dry roasted, 1 oz

4.3

20

Peanut butter, smooth, fortified, 2 tablespoons

4.2

20

Corn oil, 1 tablespoon

1.9

10

Spinach, frozen, chopped, boiled, ½ cup

1.6

6

Vitamin E in supplements is usually consumed as alpha-tocopheryl
acetate, a more stable form.  The body converts the esters to
tocopherols.  Recommended daily allowances of vitamin E are:

Table 3: Recommended Dietary Allowances for vitamin E for Children and
Adults

Age (years)

Children (mg/day)

Men (mg/day)

Women (mg/day)

Pregnancy (mg/day)

Lactation (mg/day)

1-3

6 mg

(=9 IU)

4-8

7 mg (=10.5 IU)

9-13

11 mg (=16.5 IU)

11 mg (=16.5 IU)

15 mg (=22.5 IU)

19 mg (=28.5 IU)

14+

15 mg (=22.5 IU)

15 mg (=22.5 IU)

15 mg (=22.5 IU)

19 mg (=28.5 IU)

]

	ii. Drinking Food. [No significant exposure of vitamin E via drinking
water is anticipated, except in bottled water that contains dietary
supplements, where vitamin E may be added intentionally.]

	2. Non-dietary exposure. [Vitamin E is used in skin creams and lotions,
from small concentrations up to 100% vitamin E in some skin care
products.  Some absorption through the skin is expected.]

D. Cumulative Effects

	[Vitamin E has no significant toxic effects for consideration of
cumulative effects.]

E. Safety Determination

	1. U.S. population. [Alpha-tocopherol is a low toxicity vitamin that is
used as a food chemical antioxidant.  Alpha-tocopherol is utilized by
the body and is part of the current US diet.  Therefore the proposed new
use of alpha-tocopherol as an ingredient in pesticide formulations is
not anticipated to contribute significantly to the amount of
alpha-tocopherol in the US diet and has a reasonable certainty of no
harm to the US population.]

	2. Infants and children. [Alpha-tocopherol has no significant toxic
effects that are specific to infants or children.  The proposed new use
of alpha-tocopherol as an ingredient in pesticide formulations has a
reasonable certainty of no harm to infants or children.]

F. International Tolerances

	[In the 2002 Joint FAO/WHO Expert Consultation Report, a lack of
sufficient data was cited for not determining a global agreed-upon
Recommended Nutrient Intake (RNI).  This report, however, comments that
100 to 200 mg/day intake of supplements is common, and that toxicity is
not thought to be a problem except at high intake levels, e.g., >1000
mg/day.]

 PAGE

 PAGE   10

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{</P>}

{</P>}

{</P>}


[Federal Register Volume 88, Number 117 (Tuesday, June 20, 2023)]
[Notices]
[Page 39843]
[FR Doc No: 2023-13073]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 15054-001, 15059-001, 15060-001]

Kinet, Inc.; Notice of Surrender of Preliminary Permit

    Take notice that Kinet, Inc., permittee for the proposed Kentucky
River Lock and Dams Nos. 5, 6, and 8, has requested that its
preliminary permits be terminated. The permits were issued on June 9,
2021 \1\ and would have expired on May 31, 2025. The projects would
have been located at the Kentucky River Authority's Lock and Dams Nos.
5, 6, and 8 on the Kentucky River in Anderson, Garrard, Jessamine,
Woodford, Madison, and Mercer Counties, Kentucky.
---------------------------------------------------------------------------

    \1\ 175 FERC ] 62,151-153 (2021).
---------------------------------------------------------------------------

    The preliminary permits for Project Nos. 15054, 15059, and 15060
will remain in effect until the close of business, thirty days from the
date of this notice. But, if the Commission is closed on this day, then
the permit remains in effect until the close of business on the next
day in which the Commission is open.\2\ New applications for this site
may not be submitted until after the permit surrender is effective.
---------------------------------------------------------------------------

    \2\ 18 CFR 385.2007(a)(2) (2022).

    Dated: June 13, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-13073 Filed 6-16-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 132 (Tuesday, July 10, 2018)]
[Rules and Regulations]
[Pages 31857-31858]
[FR Doc No: 2018-14668]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2017-1188; Airspace Docket No. 17-AEA-23]
RIN 2120-AA66

Amendment of Class D Airspace and Class E Airspace; Wrightstown,
PA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class D airspace, Class E airspace
designated as an extension to a Class D surface area, and Class E
airspace extending upward from 700 feet above the surface by updating
the airport name to McGuire Field (Joint Base McGuire-Dix-Lakehurst).
This action also amends Class E airspace extending upward from 700 feet
above the surface in Wrightstown, NJ, by updating the name and
geographic coordinates of Ocean County Airport (formerly Robert J.
Miller Airpark, Toms River, NJ). Also, an editorial change is made
where necessary, removing the city from the airport name in the
airspace designation. Controlled airspace is necessary for the safety
and management of instrument flight rules (IFR) operations in the area.
This action also updates the geographic coordinates of the Lakehurst
(Navy) TACAN and Colts Neck VOR/DME.

DATES: Effective 0901 UTC, September 13, 2018. The Director of the
Federal Register approves this incorporation by reference action under
title 1, Code of Federal Regulations, part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11B, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11B at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Ave, College Park, GA 30337; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class D and Class E airspace in Wrightstown, NJ to support
IFR operations in the area.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (83 FR 12511, March 22, 2018) for Docket No. FAA-2017-1188 to
amend Class D airspace, Class E airspace designated as an extension to
a Class D surface area, and Class E airspace extending upward from 700
feet or more above the surface at McGuire Field (Joint Base McGuire-
Dix-Lakehurst), Wrightstown, NJ (formerly McGuire AFB (Joint Base
McGuire-Dix-Lakehurst), and Ocean County Airport, (formerly Robert J.
Miller Airpark).
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class D and E airspace designations are published in paragraph
5000, 6004, and 6005, respectively, of FAA Order 7400.11B dated August
3, 2017, and effective September 15, 2017, which is incorporated by
reference in 14 CFR part 71.1. The Class D and E airspace designations
listed in this document will be published subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11B, Airspace Designations and
Reporting Points, dated August 3, 2017, and effective September 15,
2016. FAA Order 7400.11B is publicly available as

listed in the ADDRESSES section of this document. FAA Order 7400.11B
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends Class D airspace, Class E airspace designated as an
extension to a Class D surface area, and Class E airspace extending
upward from 700 feet or more above the surface by updating the names of
McGuire Field (Joint Base McGuire-Dix-Lakehurst), (formerly McGuire
AFB), Wrightstown, NJ, and Ocean County Airport, (formerly Robert J.
Miller Airpark, Toms River, NJ).
    The geographic coordinates of the Ocean County Airport, Lakehurst
(Navy) TACAN, and Colts Neck VOR/DME also are adjusted in the
associated airspace listed above to coincide with the FAA's
aeronautical database. These changes enhance the safety and management
of IFR operations in the area.
    An editorial change is also made to the Class E airspace extending
upward from 700 feet above the surface by removing the city from the
airport names listed to comply with a change to FAA Order 7400.2L,
Procedures for Handling Airspace Matters, and removing the exclusionary
language from the airspace description.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a regulatory evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
only affects air traffic procedures and air navigation, it is certified
that this rule, when promulgated, does not have a significant economic
impact on a substantial number of small entities under the criteria of
the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11B, Airspace Designations and Reporting
Points, dated August 3, 2017, effective September 15, 2017, is amended
as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AEA NJ D Wrightstown, NJ [Amended]

McGuire Field (Joint Base McGuire-Dix-Lakehurst), NJ
    (Lat. 40[deg]00'56'' N, long. 74[deg]35'30'' W)

    That airspace extending upward from the surface to and including
2,600 feet MSL within a 4.5-mile radius of McGuire Field (Joint Base
McGuire-Dix-Lakehurst).

Paragraph 6004 Class E Airspace Designated as an Extension to a
Class D Surface Area.

* * * * *

AEA NJ E4 Wrightstown, NJ [Amended]

McGuire Field (Joint Base McGuire-Dix-Lakehurst), NJ
    (Lat. 40[deg]00'56'' N, long. 74[deg]35'30'' W)
McGuire VORTAC
    (Lat. 40[deg]00'34'' N, long. 74[deg]35'47'' W)

    That airspace extending upward from the surface within 1.8 miles
each side of the McGuire VORTAC 350[deg] radial extending from the
4.5-mile radius of McGuire Field (Joint Base McGuire-Dix-Lakehurst),
to 6.1 miles north of the VORTAC and within 1.8 miles each side of
the McGuire VORTAC 051[deg] radial extending from the 4.5-mile
radius of the airport to 6.1 miles northeast of the VORTAC and
within 1.8 miles each side of the McGuire VORTAC 180[deg] radial
extending from the 4.5-mile radius of the airport to 5.2 miles south
of the VORTAC, and within 1.8 miles each side of the McGuire Field
(Joint Base McGuire-Dix-Lakehurst), ILS localizer southwest course
extending from the 4.5-mile radius of the airport to 7 miles
southwest of the localizer.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AEA NJ E5 Wrightstown, NJ [Amended]

Lakewood Airport, NJ
    (Lat. 40[deg]04'00'' N, long. 74[deg]10'40'' W)
McGuire Field (Joint Base McGuire-Dix-Lakehurst), NJ
    (Lat. 40[deg]00'56'' N, long. 74[deg]35'30'' W)
Trenton-Robbinsville Airport, NJ
    (Lat. 40[deg]12'50'' N, long. 74[deg]36'06'' W)
Monmouth Executive Airport, NJ
    (Lat. 40[deg]11'12'' N, long. 74[deg]07'28'' W)
Ocean County Airport, NJ
    (Lat. 39[deg]55'34'' N, long. 74[deg]17'44'' W)
Lakehurst (Navy) TACAN
    (Lat. 40[deg]02'13'' N, long. 74[deg]21'11'' W)
Colts Neck VOR/DME
    (Lat. 40[deg]18'42'' N, long. 74[deg]09'35'' W)
Coyle VORTAC
    (Lat. 39[deg]49'02'' N, long. 74[deg]25'54'' W)
Robbinsville VORTAC
    (Lat. 40[deg]12'09'' N, long. 74[deg]29'42'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.4-mile radius of Lakewood Airport, and within a 10.5-mile
radius of McGuire Field (Joint Base McGuire-Dix-Lakehurst), and
within an 11.3-mile radius of the Lakehurst (Navy) TACAN extending
clockwise from the TACAN 310[deg] radial to the 148[deg] radial and
within 4.4 miles each side of the Coyle VORTAC 031[deg] radial
extending from the VORTAC to 11.3 miles northeast, and within 2.6
miles southwest and 4.4 miles northeast of the Lakehurst (Navy)
TACAN 148[deg] radial extending from the TACAN to 12.2 miles
southeast, and within a 6.4-mile radius of Trenton-Robbinsville
Airport and within 5.7 miles north and 4 miles south of the
Robbinsville VORTAC 278[deg] and 098[deg] radials extending from 4.8
miles west to 10 miles east of the VORTAC, and within a 6.7-mile
radius of Monmouth Executive Airport and within 1.8 miles each side
of the Colts Neck VOR/DME 167[deg] radial extending from the
Monmouth Executive Airport 6.7-mile radius to the VOR/DME and within
4 miles each side of the 312[deg] bearing from Monmouth Executive
airport extending from the 6.7-mile radius of the airport to 9 miles
northwest of the airport and within a 6.5-mile radius of Ocean
County Airport and within 1.3 miles each side of the Coyle VORTAC
044[deg] radial extending from the 6.5-mile radius to the VORTAC.

    Issued in College Park, Georgia, on July 2, 2018.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2018-14668 Filed 7-9-18; 8:45 am]
 BILLING CODE 4910-13-P