[Federal Register Volume 85, Number 76 (Monday, April 20, 2020)]
[Proposed Rules]
[Pages 21793-21795]
[FR Doc No: 2020-08175]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0192; Airspace Docket No. 20-AEA-3]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Glens Falls, NY

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E surface airspace, and
Class E airspace extending upward from 700 feet above the surface at
Floyd Bennett Memorial Airport, (previously Warren County Airport),
Glens Falls, NY due to the decommissioning of the Glens Falls VORTAC,
and cancellation of associated approaches. Controlled airspace is
necessary for the safety and management of instrument flight rules
(IFR) operations in the area. This action also would update the
airport's name.

DATES: Comments must be received on or before June 4, 2020.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2020-0192; Airspace Docket No. 20-AEA-3, at the
beginning of your comments. You may also submit comments through the
internet at https://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at https://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 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, 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 would amend Class E airspace at Floyd Bennett Memorial Airport,
Glens Falls, NY to support IFR operations in the area.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2020-0192 and Airspace Docket No. 20-AEA-3) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number.) You may also submit comments through the
internet at https://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2020-0192; Airspace Docket No. 20-AEA-3.'' The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays at the office
of the Eastern Service Center, Federal Aviation Administration, Room
350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA proposes an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to amend Class E surface airspace and
Class E airspace extending upward from 700 feet above the surface at
Floyd Bennett Memorial Airport, Glens Falls, NY. In addition, the FAA
proposes to update the airport's name.
    Class E airspace designations are published in Paragraphs 6002, and
6005, respectively of FAA Order 7400.11D, dated August 8, 2019, and
effective September 15, 2019, which is incorporated by reference in 14
CFR 71.1. The Class E airspace designations listed in this document
will be published subsequently in the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed 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
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 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 7400.11D, Airspace Designations and Reporting
Points, dated August 8, 2019, and effective September 15, 2019, is
amended as follows:

Paragraph 6002 Class E Surface Airspace

* * * * *

AEA NY E2 Glens Falls, NY [Amended]

Floyd Bennett Memorial Airport, NY
    (Lat. 43[deg]20'28'' N, long. 73[deg]36'37'' W)
    That airspace extending upward from the surface within a 4-mile
radius of the Floyd Bennett Memorial Airport extending clockwise
from a 357[deg] bearing to a 275[deg] bearing from the airport and
within a 9.6-mile radius of the Floyd Bennett Memorial Airport
extending clockwise from a 275[deg] bearing to a 307[deg] bearing
from the airport and within a 6.6-mile radius of the Floyd Bennett
Memorial Airport extending clockwise from a 307[deg] bearing to a
357[deg] bearing fr124om the airport, and within 2 miles each side
of a 121[deg] bearing extending from the airport to 10-miles
southeast of the airport.

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

* * * * *

AEA NY E5 Glens Falls, NY [Amended]

Floyd Bennett Memorial Airport, NY
    (Lat. 43[deg]20'28'' N, long. 73[deg]36'37'' W)
    That airspace extending upward from 700 feet above the surface
within a 12.3-mile radius of Floyd Bennett Memorial Airport
extending clockwise from a 050[deg] bearing to a 220[deg] bearing
from the airport and within a 16.1-mile radius of the airport
extending clockwise from a 220[deg] bearing to a 050[deg] bearing
from the airport.

    Issued in College Park, Georgia, on April 2, 2020,
Ryan Almasy,
Manager, Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2020-08175 Filed 4-17-20; 8:45 am]
 BILLING CODE 4910-13-P


MEMORANDUM SUBJECT: Transmittal of the Meeting Minutes of the Endocrine Disruptor Methods Validation Subcommittee under the National Advisory Council for Environmental Policy and Technology ( NACEPT), held December 4, 2002.

TO: Dorothy Bowers, Chair National Advisory Council for Environmental Policy and Technology Office of Cooperation and Environmental Management And Gwen Whitt, Designated Federal Official National Advisory Council for Environmental Policy and Technology Office of Cooperation and Environmental Management FROM: Jane Scott Smith, Designated Federal Official / s/ NACEPT Endocrine Disruptor Methods Validation Subcommittee Office of Science Coordination and Policy/ OPPTS THRU: Joseph Merenda, Director / s/ Chair of Endocrine Disruptor Methods Validation Subcommittee Office of Science Coordination and Policy/ OPPTS Please find attached the minutes of the NACEPT Endocrine Disruptor Methods Validation Subcommittee sixth open meeting that was conducted as the second teleconference and held in Washington, D. C. December 4, 2002. The focus of this meeting was a Detailed Review Paper ( DRP), on the Fish Lifecycle Assay.

Information about NACEPT EDMVS meetings and activities can be obtained from the website at http:// www. epa. gov/ scipoly/ oscpendo, the OPPT Docket, [ OPPT 2002 0059] at ( 202) 566 0280, or by going to www. epa. gov/ epahome/ dockets. htm and searching for OPPT 2002 0059. Interested persons are invited to contact Jane Smith, EDMVS Designated Federal Official ( DFO), via e mail at smith. jane scott@ epa. gov. cc:

Sonia Altieri Charles Auer Daiva Balkus Dennis Deziel Susan Hazen Stephen Johnson James Jones William Jordan Marcia Mulkey Margaret Schneider Adam Sharp OPPT Docket 2002 0059 MEETING MINUTES OF ENDOCRINE DISRUPTOR METHODS VALIDATION SUBCOMMITTEE A Subcommittee of The National Advisory Council for Environmental Policy and Technology TELECONFERENCE ON DECEMBER 4, 2002 AT RESOLVE, 1255 23RD STREET, N. W. SUITE 275 WASHINGTON, D. C.

The Topic of this meeting was Presentation and Discussion of the Fish Lifecycle Detailed Review Paper ( DRP).

____________/ s/__ ________________ / s/________________________

Jane Scott Smith, DFO Joseph Merenda, Chair Endocrine Disruptor Methods Validation Endocrine Disruptor Methods Validation Subcommittee under the National Subcommittee under the National Advisory Council for Environmental Advisory Council for Environmental Policy and Technology Policy and Technology Date: ______ 2/ 6/ 2003_______ Date: 2/ 13/ 2003______ _ ____

i TABLE OF CONTENTS Page Official Signatures...................................................................... i Attendees................................................................................... 2 Presenters ................................................................................. 3 Public Commenters .................................................................... 3 Notice......................................................................................... 4 Meeting Agenda.......................................................................... 5 Meeting Introduction and Summary............................................ 7 Attachment A                       15 2 EDMVS Members in Attendance at the December 2002 Teleconference Attended in Person at RESOLVE Joseph Merenda, Chair William Benson, Ph. D., Co Chair U. S. EPA U. S. EPA William Stokes, D. V. M. NIEHS Attended Via Telephone Theodora Colborn, Ph. D Ron Miller, Ph. D World Wildlife Fund The Dow Chemical Company Robert Combs , Ph. D. Susan C. Nagel, Ph. D. Fund for Replacement of Animals University of Missouri Columbia In Medical Experiments James W. " Willie" Owens, Ph. D. Rodger D. Curren, Ph. D. The Procter & Gamble Company Institute for In Vitro Sciences, Inc ( on temporary detail to OECD)

J. Charles Eldridge, Ph. D. Thomas L. Potter, Ph. D. Wake Forest University USDA Agriculture Research Service Robert J. Kavlock, Ph. D. Theodore H. Schettler M. D., MPH U. S. EPA Science & Environ. Health Network William Kelce, Ph. D. Shane A. Snyder, Ph. D. Pharmacia Corporation Southern NV Water Authorilty Nancy K. Kim, Ph. D. James T. Stevens. Ph. D. NY State Department of Health Wake Forest University Timothy Kubiak, M. P. H. Glen Van Der Kraak, Ph. D. U. S. Fish and Wildlife Service University of Guelph Gerald A. LeBlanc, Ph. D. James D. Yager, Jr., Ph. D. North Carolina State University Johns Hopkins University Facilitator Designated Federal Official Paul De Morgan Jane Scott Smith RESOLVE Office of Science Policy and Coordination 3 Presenter Presenter Les Touart EPA, OSCP Public Oral Commenters Public Commenters Rick Becker ACC Troy Seidle PETA 4 NOTICE This meeting summary has been written as part of the activities of the National Advisory Council on Environmental Policy and Technology ( NACEPT), Endocrine Disruptor Methods Validation Subcommittee ( EDMVS). This meeting summary has not been reviewed for approval by the United States Environmental Protection Agency ( Agency) and, hence, the contents of the meeting summary do not necessarily represent the views and policies of the Agency, nor of other agencies in the Executive Branch of the Federal government, nor does mention of trade names or commercial products constitute a recommendation for use.

The NACEPT EDMVS was established in partial fulfillment of a Congressional statute. When Congress amended the Federal Food Drug and Cosmetics Act ( FFDCA) in the Food Quality Protection Act ( FQPA) of 1996, it directed the U. S. Environmental Protection Agency ( EPA) to develop a screening program to determine whether certain substances may have hormonal effects in humans. To ensure that EPA has the best and most up to date advice available regarding the validation of the screens and tests in the EDSP, EPA established the Endocrine Disruptor Methods Validation Subcommittee ( EDMVS) under the NACEPT. The EDMVS provides independent advice and counsel to the Agency through NACEPT on scientific and technical issues related to validation of the EDSP Tier I and Tier II assays, including advice on methods for reducing animal use, refining procedures involving animals to make them less stressful, and replacing animals where scientifically appropriate. The EDMVS held their first meeting in October of 2001, their second meeting in December 2001, and their third meeting in March 2002. The fourth meeting of the EDMVS was conducted as an international teleconference in June 2002. The fifth meeting was in July of 2002 and sixth was conducted as an international teleconference in December of 2002.

The December 4, 2002 open meeting ( teleconference) of the EDMVS was announced in the Federal Register on November 14, 2002 ( Volume 67, Number 220). Further information about NACEPT EDMVS meetings and activities can be obtained from its website at http:// www. epa. gov/ scipoly/ oscpendo or the OPPT Docket at ( 202) 566 0280. INTERESTED PERSONS ARE INVITED TO CONTACT Jane Smith, EDMVS Designated Federal Official ( DFO), via e mail at smith. jane scott@ epa. gov. 5 National Advisory Council for Environmental Policy and Technology ( NACEPT)

Endocrine Disruptor Methods Validation Subcommittee ( EDMVS)

Meeting by Conference Call December 4, 2002 10: 00 a. m.   12: 00 noon EST Proposed Agenda Members of the public may join this conference call in person at the conference room in the RESOLVE offices at 1255 23rd St. NW, Suite 275, Washington, DC. To register to participate by phone, please contact Jane Smith, designated federal official for the EDMVS, at smith. janescott epa. gov or ( 202) 564 8476. Also note that members of the public who would like to make comments during the conference call need to contact Ms. Smith prior to the meeting.

Meeting Objective:   Provide comments and advice on the Fish Lifecycle DRP ( Tier II).

10: 00   10: 05 Phoning in 10: 05  10: 10 Welcome and Opening Comments o Roll Call o Overview of FACA Requirements 10: 10   10: 30 Fish Lifecycle DRP ( Tier II) Presentation Dr. Les Touart, Office of Science Coordination and Policy ( OSCP), EPA 10: 30   11: 40 Discussion on Fish Lifecycle DRP The purpose of this DRP is to define the basis and purpose of the proposed two generation test for evaluating endocrine effects. The DRP summarizes, explains, and documents decisions regarding the relevant principles, methods, and techniques recommended for an initial protocol with four candidate species of fish ( fathead minnow, zebrafish, medaka, and sheepshead minnow), and identifies issues that might require prevalidation studies to adequately address information gaps. Please use the following questions as a guide for your feedback to EDSP:

1. Does the EDMVS agree that the two generation method recommended and applicable to four species of fish is appropriate?

2. Does the EDMVS agree that prevalidation should evaluate the increased sensitivity of a two generation design over the existing fish full life cycle standard practice?

3. Does the EDMVS agree that prevalidation should demonstrate the sensitivity and reproducibility for each species in the recommended protocol? 6 4. Does the EDMVS have suggestions to improve the DRP?

11: 40   11: 55 Public Comment Members of the public who would like to make comments during the conference call must contact Jane Smith, designated federal official for the EDMVS, at smith. jane scott@ epa. gov or ( 202) 564 8476. Members of the public are requested to focus their comments on issues related to the Fish Lifecycle DRP to the extent possible.

11: 55   12: 00 Next Steps 12: 00 Adjourn 7 Introduction The Office of Science Coordination and Policy's Endocrine Disruptor Screening program established the Endocrine Disruptor Methods Validation Subcommittee ( EDMVA) under The National Advisory Council for Environmental Policy and Technology ( NACEPT). All of the subcommittee meetings are held in accordance with the Federal Advisory Committee Act and are always open to the public with time available for public comment. The first EDMVS meeting was held in October 2001. That initial meeting brought the members together to review the mission statement, the operating procedures and discuss subcommittee roles and responsibilities. The second meeting, held in December 2001, was the first time the subcommittee members were presented with specific questions regarding assay protocols. The third meeting, held March 2002, continued discussions on protocols as well as some discussions on the validation process, Core Chemicals, ` low dose' and means of assessing human health effects. The fourth meeting, held as a teleconference, was wholly concerned with the Steroidogenesis assay. The fifth meeting continued discussions on protocols as well as some discussions on the EDMVS work plan, the criteria for screens and general dose setting issues.

Endocrine Disruptor Methods Validation Subcommittee ( EDMVS) Meeting by Conference Call December 4, 2002 Meeting Summary  Final

On December 4, 2002, the U. S. Environmental Protection Agency ( EPA) convened a meeting of the Endocrine Disruptor Methods Validation Subcommittee ( EDMVS) by conference call. The objective of the meeting was to provide comments and advice on the Draft Detailed Review Paper on a Fish Two Generation Toxicity Test. The meeting took place in Washington, DC; however, many of the EDMVS members, as well as some members of the public, participated by phone.

Copies of presentation slides and other materials distributed at the meeting may be obtained by contacting Jane Smith, the designated federal official for EDMVS, at smith. jane scott@ epa. gov or 202/ 564 8476. The materials also are available on the EPA website at http:// www. epa. gov/ scipoly/ oscpendo/ edmvs. htm. EPA has established an administrative record for this meeting under docket control number OPPT 2002 0059. The docket is available for public viewing at the EPA Docket Center, Rm. B102   Reading Room, EPA West, 1301 Constitution Ave., NW., Washington, DC. The center is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. 8 The center's phone number is ( 202) 566 1744 and the telephone number for the OPPT Docket, which is located in the EPA Docket Center, is ( 202) 566 0280.

I. Opening Comments, Roll Call, and Agenda Review Paul De Morgan, senior mediator with RESOLVE, welcomed EDMVS members and other participants to the meeting and thanked them for attending by phone or in person. He introduced Joe Merenda, Director of the Office of Science Coordination and Policy ( OSCP) and new chair of the EDMVS. Mr. Merenda highlighted the Endocrine Disruptor Screening Program ( EDSP) as one of the most visible and critical of that office's functions, and he expressed his enthusiasm for being involved with the subcommittee and learning more about the issues.

Jane Smith, designated federal official for the EDMVS, explained that the meeting was being held in accordance with the Federal Advisory Committees Act ( FACA) and all materials distributed would be available through the docket and on the website. She invited anyone experiencing problems with the website or other concerns to contact her. She asked participants to send her the comments. All written comments will be posted on the EDSP website at the address noted above.

Mr. De Morgan did a roll call of EDMVS members and public participants who had registered and asked other participants to announce their names. ( Please see attachment A for a list non member meeting attendees.) He asked subcommittee members to let him know at the end of the conference call if the two hour time period for the discussion was insufficient to address all topics. He encouraged participants to submit written comments to Ms. Smith if they were unable to raise them on the call. He then reviewed the meeting agenda.

II. Fish Two Generation Toxicity Test DRP Les Touart, OSCP, gave a slide presentation on A Fish Two Generation Toxicity Test Detailed Review Paper ( DRP). He noted the methods used in the DRP analysis, including an online literature search, interviews with experts, and an external/ internal peer review. He explained existing fish lifecycle tests do not address relevant biochemical, morphological, and behavioral endpoints. Further, transgenerational endocrine effects are not assessed in current tests. For these reasons, EPA recommends replacing existing lifecycle tests with a two generation test that addresses these factors. Dr. Touart covered characteristics and strengths and weaknesses of the fathead minnow ( Pimephales promelas), medaka ( Oryzias latipes), zebrafish ( Danio rerio), and the sheepshead minnow ( Cyprinodon variegates) test species. Other presentation comments included the following:

For candidate replacement tests, the principal route of administration of chemical 9 exposure is aqueous, other optional routes include dietary, intravascular, and intraperitoneal injection.

Measurement endpoints include morphological alterations, reproductive performance, and biochemical measures including vitellogenin induction.

Vitellogenin is measured using direct and indirect quantification of vitellogenin protein, quantification of vitellogenin mRNA, and mass spectrometry.

Candidate protocols include partial life cycle, full life cycle, multigeneration, and two generation tests, and the DRP recommends moving forward with the proposed two generation protocol.

This test exposes the adult P, full F1 generation, and measures F2 viability, measuring biological endpoints for the adults and both subsequent generations.

Dr. Touart noted the significant data gaps that exist but commented that information is improving quickly. He also outlined implementation considerations, including prevalidation studies and validation of the study design through interlaboratory comparisons.

Following his presentation, Dr. Touart answered questions of clarification from EDMVS members. He explained that the concept of the partial lifecycle test is similar to the short term reproduction test that uses breeding groups and exposure information to guide the selection of spawning groups for exposure and helps to reduce variability.

The purpose of the protocol, as a tier 2 test, is defined as definitively evaluating endocrine potential and adverse effects of a compound on the lifecycle, including survival, ability to reproduce, and growth. Further, transgenerational factors such as the viability of offspring are intended to be tested. This protocol will address endpoints relevant for predicting population effects, which are an important component for ecological risk assessments. The protocol would be triggered for a compound when the tier 1 screen or other available information indicate a potential for interfering with hormone activity.

A member asked whether there are differences between EPA's approach and that of OECD, in that OECD has a 3 tier approach with a step between mechanistic screens and two generation tests. Dr. Touart explained there is not discordance, as OECD has not established an official tiered framework. While endpoints used at the screening level are still under discussion, any indication that a compound will impact the endocrine system of a fish species will trigger a further evaluation of that compound. He agreed that additional information may sometimes be needed before beginning a twogeneration test, and an intermediate tier could help with range finding. However, a compound found to act on the endocrine system will require a definitive test such as the two generation test, regardless of whether a partial lifecycle test or other intermediate level test is run first. The member disagreed that a two generation test would be necessary in all cases. 10 III. EDMVS Member Discussion of the Fish Lifecycle DRP Mr. De Morgan referred members to the discussion questions listed in the agenda and asked for their input, noting that the first was a two part question ( as shown below). Because of interrelated nature of the questions, EDMVS members touched on all four questions throughout the course of the conference call. Thus, the comments summarized under each of the questions below may overlap across questions.

1a. Does the EDMVS agree that the two generation method recommended in the DRP is appropriate and an improvement over the previous fathead minnow tests?

A member emphasized the importance of assessing egg or embryo exposure to the chemical and expressed a concern that 14 21 days of exposure would not be sufficient to establish steady state for more lipophilic chemicals, and therefore would not expose the egg or embryo. He noted that the multigeneration test would better handle egg/ embryo exposure. Alternatively, the two generation test could forego the F2 generation and instead lengthen parental exposure and then take the F1 generation to full reproductive maturity. Another member noted that the multigeneration test has the advantage of exposing all lifecycle stages.

A member suggested comparing the two generation test with existing protocols to better understand the unique benefits of the proposed test. Dr. Touart responded that EPA is already considering doing an evaluation of the two generation and full lifecycle test. He also said they could consider conducting additional comparisons.

One member commented that since fish are not covered by the Animal Welfare Act, these validation studies should be conducted in accordance with the Public Health Service Policy on the Humane Care and Use of Laboratory Animals, which is applicable to all vertebrate species. He added that this would ensure that all animal care and use was reviewed and overseen by an animal care and use committee, and that such care and use was accomplished in accordance with the National Research Council Guide for the Care and Use of Laboratory Animals.

1b. Are the four species ( fathead minnow, medaka, zebrafish, and sheepshead minnow) appropriate candidates for this test?

A member asked why it is necessary to use four species of fish, and, if all four were used, how data would be interpreted. Another member pointed out that there are international species preferences, and the prevalidation stage is the time to determine how the different species compare. Dr. Touart explained that the medaka and zebrafish were included as candidates because of their favor in other countries. The sheepshead minnow was added for practicality, as this species has a historical context and brings in the ecological context of estuarine/ marine effects. Dr. Touart highlighted the importance of maintaining cross species comparisons and extrapolations. These species are advantageous both in EPA's familiarity with them as well as their potential to be 11 accepted and compared internationally. He noted that existing methodologies are somewhat limited in their international applicability. A member added that testing the protocol with all four species early on will result in more information and, hopefully, fewer animals would be needed once the test is validated and part of the battery.

A member suggested conducting a retrospective review of existing data to determine what is known about comparative sensitivity between species. A pilot study could also help determine differences in sensitivity for effects at low concentrations for weak acting chemicals and could save many animals in later testing. A member agreed that governments should be able to detect whether there are species specific effects, and another EDMVS member highlighted the importance of ensuring that data collected will have mutual acceptance in the international community.

One member said that EPA should consider using species for tier 2 tests for which data has been collected in tier 1 screens, especially if the sensitivity of all four species is comparable. Gary Ankley, EPA, said that there is no reason to suspect the species would differ greatly with respect to sensitivity, especially when tested in conserved systems. Differences in sensitivity would likely be related to experimental design rather than innate differences in the species. Dr. Ankley shared that the decision depends mostly on practicality and geopolitical preferences for particular species.

2. Does the EDMVS agree that prevalidation should evaluate the increased sensitivity of a two generation design over the existing fish full lifecycle standard practice?

A member suggested that the partial lifecycle test be considered along with the twogeneration design. Another member commented that the partial lifecycle test does not have full exposure for maternal uptake and exposure to offspring. Dr. Touart referenced the previous suggestion to investigate the multigeneration test as well. Another member agreed that the multigeneration test should be evaluated along with the two generation test, as it reflects co exposure to other types of information such as salinity levels in the aqueous environment.

A member supported using the historical database for the partial and full lifecycle test, noting that there is prevalidation information available for full lifecycle tests in the fathead and sheepshead minnows. Rather than proposing new compounds, he asked EDMVS members to share their thoughts about using the existing database of compounds to conduct multigeneration or two generation tests. One member encouraged this plan, adding that results should be compared to those of early life stage test results to determine the added value of the two generation test. Another member raised the issue that previous evaluations, such as early life stage studies, did not include endocrine endpoints.

Members asked about the contents of the database, conclusions that can be drawn from it, and the general practicality of using these data. Dr. Touart explained that the data reviews are secondary information within EPA's files, but the actual studies would have to be released from the companies involved. He added that there have been 12 previous reviews of EPA's fish lifecycle data set in combination with other data sets, and those discussions and conclusions could be made available to the subcommittee. Dr. Touart also called the subcommittee's attention to EPA's draft proposal to OECD on the fish two generation guideline, which highlights EPA's plan to make ample use of international resources and depend as much as is feasible on retrospective analyses.

3. Does the EDMVS agree that prevalidation should demonstrate the sensitivity and reproducibility for each species in the recommended protocol?

The group began by discussing routes of exposure. Members commenting on route of exposure indicated support for aqueous exposure as the most relevant and practical route, especially considering that the preponderance of data available is based on this route of exposure. Regarding other routes considered by EPA ( dietary and direct injection techniques), Dr. Touart indicated that these exposures would be used only in a special case. He agreed that, in general, aqueous exposure would be the most ecologically relevant route.

A member asked whether the fate of chemicals would be tested to determine whether they are detectable in water or food. Dr. Touart responded that if a compound has no strong exposure potential, it is unlikely that it would move into tier 2. He reiterated that EPA would focus on the aqueous route of administration in prevalidation because the majority of compounds would act through that route. A member suggested that using dietary exposure would require a validation or prevalidation study separate from tests using aqueous administration.

Some members revisited the issue of steady state, pointing out that for chemicals with special characteristics, such as lipophilic compounds, the route and length of exposure requires unique consideration. One member suggested that EPA consult the literature on this matter.

Mr. De Morgan summarized members' suggestions, noting that EPA should be explicit about steady state and its relevance to routes of exposure when completing protocols. A member added that EPA should be aware of any variability related to whether test subjects reach steady state and thus the comparability of endpoints.

4. Does the EDMVS have suggestions to improve the DRP?

Members asked EPA to include comparisons with database information relevant to the protocol in the DRP, as these comparisons would be helpful in getting a sense of the variability in endpoints. One member noted that some existing data are reflected in the DRP, and these references should be included. Dr. Touart explained that some data were from EPA studies and can be shared. EPA can also share their reviews of data from secondary research, but the actual studies would have to be released by registrants. Before proceeding, EPA would need to determine the relevance of existing data to this test. 13 A member suggested that bringing closure to the discussion of different protocols would improve the DRP. He added that some of the vitellogenin techniques seem time consuming and asked whether a more rapid method was available for tests. Dr. Touart agreed that the DRP could do a more thorough job of drawing conclusions. Regarding vitellogenin, Dr. Touart explained that there is ongoing research to compare methods.

In response to a question on steroid receptors, Dr. Touart encouraged members to send comments. These and any other comments from the EDMVS or the public would be most helpful if received by the first week of January.

IV. Public Comment Rick Becker, American Chemistry Council Dr. Becker commented that geopolitical realities need to be addressed, and EPA should take a leadership role with OECD in discussing comparability. He stressed that mutual acceptance of data is critical, and EPA should plan for it up front. A comparison of the protocols is needed and must determine the value added of the longer, more expensive studies. Dr. Becker asked EPA to consider both type 1 ( false positive) and type 2 ( falsenegative errors. EPA also should clarify the objective of the study as this will affect the measurement of successful validation.

Troy Seidle, People for the Ethical Treatment of Animals In regard to question 1, Mr. Seidle commented that, in principle, EPA should evaluate the sensitivity of a two generation design over the existing standard practice. EPA must be able to demonstrate a significant need as well as " value added" before a new test or endpoint is considered as a regulatory requirement. That being said, EPA's current requirement for a multiplicity of animal tests for the same or similar endpoints is redundant and unacceptable. As a matter of policy, EPA program offices must better coordinate their chemical assessment efforts in order to prevent duplication. Mr. Seidle said that in regard to question 2, from a strictly scientific perspective, the answer is yes, because it would be unwise to assume that data from one species are generalizable to another. On a policy level, however, it would be inappropriate for EPA to proceed into prevalidation of a test of this magnitude with four species; a single species is more than enough. In conclusion Mr. Seidle asked that immediate consideration be given to reducing the scope of Tier 2 to the single most sensitive species, and discontinuing efforts to develop and validate multigenerational studies in others.

V . Next Steps Dr. Touart summarized some of the comments he heard from the EDMVS members:

EPA should evaluate whether the two generation protocol is sufficient and should consider multigenerational protocol in order to cover exposure potential for eggs and embryos.

Species comparisons within the two generation method would be useful, as would comparisons to show the advantages of this protocol over lifecycle, partial lifecycle, and multigeneration tests. 14

EPA should consider geopolitical preferences in choosing a test species. A comparison across species would be valuable.

The aqueous exposure route seems most relevant. The DRP should include a discussion of the circumstances under which other exposure routes might be used.

Mr. De Morgan thanked Dr. Touart for his presentation and others for their comments and discussion. Mr. Merenda also thanked the members for the productive discussion. Noting that Ms. Smith was about to present the proposed meeting schedule, he asked members to remember that EPA is striving to balance the desire for momentum with the reality of needing to have information ready for each meeting in order to use members' time as efficiently as possible.

Mr. De Morgan asked members whether they felt the call had given them adequate time to discuss the DRP. Several members noted they had additional comments and could have used more time for the discussion. Some said they would submit written comments to Ms. Smith. Dr. Touart noted that comments would be most useful if they were received by January 10, 2003. Mr. De Morgan suggested that EPA should review the comments and then consider whether it would be beneficial to hold a second conference call or include further discussion of this DRP on the agenda of a future inperson meeting.

Proposed Future Meeting Schedule Ms. Smith presented the following proposed meeting schedule and asked members to reserve the dates, noting that the topics for each meeting are still tentative.

June 4 5, 2003 ( 2 full days) o June 4  Mammalian 2 generation ( Tier II): One generation extension study results; Avian Two Generation Assay ( Tier II) Detailed Review Paper o June 5   Steroidogenesis Assay ( Tier I): The Results of the Optimization of the Protocol using sliced testes ; Aromatase: The results of the optimization and performance comparison of the assay using placental tissues ( porcine, human, bovine) and human recombinant receptor

August 19 21, 2003 ( 2 1/ 2 days) o Aug 19 ( half day)  Fish Short Term Reproduction Assay ( Tier I): Evaluation of Vitellogenin Methods in Zebrafish & Medaka study results; Fish Reproductive: Evaluation of Vitellogenin Methods in Fathead Minnow study results o Aug 20  Fish Short Term Reproduction Assay ( Tier I): Comparative Evaluation of the Fathead Minnow Assays study results o Aug 21  Pubertals male and female: Multi dose demonstration study results; Pubertals male and female: Multi chemical Array study results The meeting was adjourned at noon. 15 Attachment A Non Members Who Joined by Phone Gary Ankley, EPA Karin Bentley, DuPont Crop Protection Ron Biever, SpringbornSmithers Laboratories Michael Blanton, Battelle Karen Bredam Scott Brown, National Water Research Institute Kristen Brugger, Crop Life of America Ralph Cooper, EPA Paul De Morgan, RESOLVE Norma Domey, Environment Canada Beth Doyle, EPA Reinhart Fischer, Bayer Crop Science Jerry Goldman, EPA Tilghman Hall, Bayer Corporation Charles Harper Kevin Henry Gary Henshaw Dave Houchens, Battelle Jerry Johnson, Battelle Susan Laws, EPA Ellen Mahaich, Rhodia Miriam Medina Vera, EPA Claudia Olivieri, BASF Troy Seidle, People for the Ethical Treatment of Animals Ann Skillman, Battelle Tim Springer, Wildlife International Tammy Stoker, EPA Non Members Who Joined the Meeting at the RESOLVE Conference Room, Washington, DC Elaine Francis, EPA Rick Becker, American Chemistry Council Sue Euling, EPA Sally Grady, EPA Jim Kariya, EPA Sara Litke, RESOLVE Rich Liroff, World Wildlife Fund Joe Nash, EPA Kazuhiko Nishroka, Japan External Trade Organization Jennifer Peyser, RESOLVE Greg Schweer, EPA 16 Jane Smith, EPA Kris Thayer, Environmental Working Group Gary Timm, EPA Les Touart, EPA Phil Zahodiakin, CRC Press, Pesticide and Toxic Chemical News


[Federal Register Volume 85, Number 222 (Tuesday, November 17, 2020)]
[Notices]
[Page 73334]
[FR Doc No: 2020-25260]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2020-1056]

Agency Information Collection Activities: Requests for Comments;
Clearance of a New Approval of Information Collection: Unmanned
Aircraft Systems (UAS) Market Survey

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval for a new information collection.
The collection involves an electronic distribution of a survey to
gather information on current practices for pilots of unmanned aircraft
systems (UAS). The target information to be gathered is the common
fatigue-related practices, and the minimum knowledge, skills, abilities
(KSAs), testing, and staffing procedures required for operating UAS.
The information to be collected will be used to inform future
rulemaking and the development of supporting guidance. The information
is necessary because the existing regulatory framework, to include the
certification of airmen, was not designed with remote pilots in mind.
To broadly integrate UAS and remote pilots into the National Airspace
System, further rulemaking will be required to address remote pilot
certification for air carrier operations and flight and duty time
periods applicable to remote pilot air carrier operations.

DATES: Written comments should be submitted by January 19, 2021.

ADDRESSES: Please send written comments:
    By Electronic Docket: https://www.regulations.gov (Enter docket
number into search field).
    By mail: Kevin Williams, Ph.D., Bldg. 13, Rm. 250D, 6500 S
MacArthur Blvd., Oklahoma City, OK 73125.
    By fax:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Ashley Awwad by email at:
<EMAIL_ADDRESS>phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including: (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.
    OMB Control Number: 2120-XXXX.
    Title: Unmanned Aircraft Systems (UAS) Market Survey.
    Form Numbers: List all forms.
    Type of Review: New information collection.
    Background: The FAA mission and vision are to provide the safest,
most efficient aerospace system in the world as new users and
technologies integrate into the system. Currently, unmanned aircraft
systems (UAS) operations are expanding beyond 14 Code of Federal
Regulations (CFR) part 107 via waiver and exemption. To broadly
integrate these expanded operations, to include air carrier operations,
further rulemaking will be necessary. To support revisions to current
regulations and the development of new regulations that will support
integration, the FAA plans to survey experts in industry and academia
on UAS. The survey seeks to collect data from industry leaders on the
common fatigue-related practices for the operation of UAS and the
minimum knowledge, skills, abilities (KSAs), testing, and staffing
procedures required for operating UAS.
    Respondents: 180 respondents.
    Frequency: One-time collection.
    Estimated Average Burden per Response: 45-minute burden per
response.
    Estimated Total Annual Burden: 135 hours, total burden.

    Issued in Oklahoma City, Oklahoma, on November 11, 2020.
Ashley Awwad,
Management & Program Analyst, Civil Aerospace Medical Institute (CAMI),
Flight Deck Human Factors Research Lab, AAM-510.
[FR Doc. 2020-25260 Filed 11-16-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 80, Number 102 (Thursday, May 28, 2015)]
[Notices]
[Page 30539]
[FR Doc No: 2015-12921]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

National Freight Advisory Committee

ACTION: Announcement of Charter Renewal for the National Freight
Advisory Committee.

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SUMMARY: This notice announces renewal of National Freight Advisory
Committee's charter for a period of 1 year (NFAC), effective May 28,
2015. The NFAC will provide information, advice, and recommendations to
the U.S. Secretary of Transportation on matters relating to U.S.
freight transportation.

FOR FURTHER INFORMATION CONTACT: Maria Lefevre, Designated Federal
Officer at<PHONE_NUMBER> or<EMAIL_ADDRESS>or visit the NFAC Web site
at www.dot.gov/nfac.

SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), DOT is giving notice of the
charter renewal for the NFAC. The NFAC is established under the
authority of the U.S. Department of Transportation, in accordance with
the provisions of the Federal Advisory Committee Act (5 U.S.C. App. 2).
The NFAC shall continue to undertake information-gathering activities,
develop technical advice, and present recommendations to the Secretary
to further inform this policy, including but not limited to
implementation of the freight provisions of the Moving Ahead for
Progress in the 21st Century Act (MAP-21), Public Law 112-141, and
other issues of freight transportation policy and programs, including
legislative recommendations. The NFAC is composed of up to 50 members
representing diverse modes of transportation; regional representation
across the Nation; relevant policy areas such as safety, labor,
environment; freight customers and providers; and government bodies.
The diversity of the Committee ensures the requisite range of views and
expertise necessary to fulfill its responsibilities.

    Issued: May 21, 2015.
Anthony R. Foxx,
Secretary.
[FR Doc. 2015-12921 Filed 5-27-15; 8:45 am]
 BILLING CODE 4910-9X-P