	SIP SUBMITTAL COMPLETENESS CRITERIA CHECKLIST

	(in accordance with 40 CFR Part 51 - App. V)

   SIP Submitted by:  Commonwealth of Virginia

     Date Submitted:   September 12, 2006

            Subject:

Completeness Review

Completed by:	           Ellen Wentworth

     Date Completed:   October 4, 2006

Administrative Materials

	ACCEPTABLE

	EPA REQUIREMENT

	STATE SUBMITTAL

(X)

1. A formal letter of submittal from the Governor or his designee, requesting EPA approval of the plan or revision thereof.

1.  Letter dated September 12, 2006 from David K. Paylor, Director, Virginia Department of Environmental Quality to Judith M. Katz, Air Protection Division, Region III.

 x

2. Evidence that the State has adopted the plan in the State code or body of regulations; or issued the permit, order, consent agreement in final form.  That evidence shall include the date of adoption or final issuance as well as the effective date of the plan, if different from the adoption/issuance date.

2.  Revision was adopted by the State Air Pollution Control Board on June 21, 2006, in accordance with the requirements of section 10.1-1308 of the Virginia Air Pollution Control Law, and 40 CFR part 51.  Effective date of the revision is October 4, 2006.

 x

3. Evidence that the State has the necessary legal authority under State law to adopt and implement the plan.

3.  Revision adopted pursuant to section 10.1-1308 of the Virginia Air Pollution Control Law.

 x

4. A copy of actual regulation, or document submitted for approval and incorporation by reference into the plan, including indication of the changes made to the existing approved plan, where applicable.  The submittal shall be a copy of the official State regulation/document signed, stamped, dated by the appropriate State official indicating that it is fully enforceable by the State.  The effective date of the regulation/document shall, whenever possible, be indicated in the document itself.

4.  Commonwealth of Virginia, Department of Environmental Quality, 9 VAC 5-20-206, volatile organic compound and nitrogen oxides emissions control areas, adopted on June 21, 2006, published in the Virginia Register on September 4, 2006, effective October 4, 2006.

x

5. Evidence that the State followed all of the procedural requirements of the State's laws and constitution in conducting and completing the adoption/issuance of the plan.

5.  A letter dated September 12, 2006, from  David K.Paylor, Director, Virginia Department of Environmental Quality to Judith M. Katz, Air Protection Division, EPA Region III.  Certification of Public Participation Activities.  Copy of public hearing notice run in the Richmond Times-Dispatch on November 28, 2005

 x

6. Evidence that public notice was given of the proposed change consistent with procedures approved by EPA, including the date of publication of such notice.

6.  Copy of hearing notice run in the November 28, 2005 Richmond Times-Dispatch indicating public hearing would be held on January 12, 2006

 x

7. Certification that public hearings were held in accordance with the information provided in the public notice and the State's laws and constitution, if applicable.

7.  Public hearing held on January 12, 2006; Certification of Public Participation Activities found in Enclosure 2 to the letter dated September 12, 2006 from David K. Paylor, Director, Virginia Department of Environmental Quality to Judith M. Katz, Air Protection Division, EPA Region III.

 x

8. Compilation of public comments and the State's response thereto.

8.  Record of Hearing and Summary of Testimony found in Enclosure 3 to the letter dated September 12, 2006 from David K. Paylor, Director, Virginia Department of Environmental Quality to Judith M. Katz, Air Protection Division, Region III.

 x

1. Identification of all regulated pollutants affected by the plan.

 1. VOC and NOx

  x

2. Identification of the locations of affected sources including the EPA attainment/nonattainment designation of the locations and the status of the attainment plan for the affected area(s).

2.  Fredericksburg, Richmond, and Hampton Roads, VA Emissions Control Areas.  The Fredericksburg Area is a moderate 8-hour ozone nonattainment area; the Richmond Area and Hampton Roads Areas are marginal 8-hour ozone nonattainment areas.

  x

3. Quantification of the changes in plan allowable emissions from the affected sources; estimates of changes in current actual emissions from affected sources or, where appropriate, quantification of changes in actual emissions from affected sources through calculations of the differences between certain baseline levels and allowable emissions anticipated as a result of the revision.

3.  N/A

 x

4. The State's demonstration that the national ambient air quality standards, prevention of significant deterioration increments, reasonable further progress demonstration, and visibility, as applicable, are protected if the plan is approved and implemented.

4.   This revision extends Chapter 40 VOC and NOx control measures into the new VOC and NOx emissions control areas established in 9 VAC 5-20-206.

x

5. Modeling information required to support the proposed revision, including input data, output data, models used,  ambient monitoring data used, meteorological data used, justification for use of offsite data (where used), modes of models used, assumptions, and other information relevant to the determination of adequacy of the modeling analysis.

5.  N/A

x

6. Evidence, where necessary, that emission limitations are based on continuous emission reduction technology.

6   N/A

x

7. Evidence that the plan contains emission limitations, work practice standards and recordkeeping/reporting requirements, where necessary, to ensure emission levels.

7.  N/A

x

8. Compliance/enforcement strategies, including how compliance will be determined in practice.

8.  N/A

x

9. Special economic and technological justifications required by any applicable EPA policies. (If a policy is not appropriate, explain why.)

9.  N/A

x

10. A Section 107 request must be accompanied by a maintenance plan demonstrating maintenance to the relevant NAAQS for at least 10 years after redesignation.

10.  N/A

X


[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31744-31745]
[FR Doc No: 2018-14559]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-507-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on June 19, 2018, Columbia Gas Transmission, LLC
(Columbia), 700 Louisiana Street,

Houston, Texas 77002-2700, filed in Docket No. CP18-507-000 a prior
notice request pursuant to sections 157.205, 157.208, and 157.216 of
the Commission's regulations under the Natural Gas Act (NGA), and
Columbia's blanket certificate issued in Docket No. CP83-76-000, to
perform installations and activities to enable the in-line inspection,
or pigging, of its 12-inch-diameter Line 5 (Line 5 Launcher & Receiver
Project: Freedom Way to Meade's Rest). The proposed project
installations and activities will include modifications to the existing
pipeline at 22 locations (Mod Points) along 22.7 miles of the existing
Line 5 right-of-way, and the installation of two bi-directional
launching and receiving stations and related appurtenances. The project
is located along the Ohio River in Brooke County, West Virginia, and
Jefferson and Columbiana counties, Ohio.
    Columbia's project proposes to perform installations and
modifications to Columbia's existing Line 5 to allow for the internal
passage of ILI devices, or pigging, in order to assess the integrity of
the pipeline. Columbia states that the project is required to ensure
compliance with the Pipeline and Hazardous Materials Safety
Administration requirements for inspections of pipeline systems to
ensure their safety and reliability.
    The project will consist of various modification activities at 22
Mod Points to enable the in-line inspection, or pigging, of Line 5.
Specifically, Columbia proposes to (1) install one new 24-inch x 20-
inch bi-directional launcher/receiver station, valves, fitting, and
pipe at Mod Point 1 in Brooke County, West Virginia; (2) install one
new 24-inch x 20-inch bi-directional launcher/receiver at Mod Point 18
in Columbiana County, Ohio; (3) install, replace, or remove
appurtenances, including valves, elbows, and pipe, at the remaining 20
Mod Points within Brooke County, West Virginia, and Jefferson and
Columbiana Counties, Ohio; and (4) abandon in-place existing pipeline
segments at Mod Point 1 in Brooke County, West Virginia, and at Mod
Points 3, and 11 in Jefferson County, Ohio, all as more fully set forth
in the application which is on file with the Commission and open to
public inspection.
    The filing may also be viewed on the web at http://www.ferc.gov
using the ``eLibrary'' link. Enter the docket number excluding the last
three digits in the docket number field to access the document. For
assistance, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to Linda
Farquhar, Manager, Project Determinations & Regulatory Administration,
Columbia Gas Transmission, LLC, 700 Louisiana Street, Suite 700,
Houston, Texas 77002-2700, by telephone at<PHONE_NUMBER>, by facsimile
at<PHONE_NUMBER>, or by email at [email protected].
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding, or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters, will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically should
submit an original and seven copies of the protest or intervention to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426.

    Dated: June 29, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-14559 Filed 7-6-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 198 (Thursday, October 13, 2016)]
[Notices]
[Pages 70670-70671]
[FR Doc No: 2016-24767]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER17-21-000]

Elevation Energy Group, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding
Elevation Energy Group, LLC's application for market-based rate
authority, with an

accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is October 25, 2016.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the Web site that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: October 5, 2016.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2016-24767 Filed 10-12-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: October 2, 2008 (Volume 73, Number 192)]
[Proposed Rules]
[Page 57270-57271]
[DOCID:fr02oc08-15]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 91

[Docket No. FAA-2007-29305; Notice No. 08-11]
RIN 2120-AI92

Automatic Dependent Surveillance--Broadcast (ADS-B) Out
Performance Requirements To Support Air Traffic Control (ATC) Service;
Reopening of Comment Period

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM); reopening of comment
period.

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

SUMMARY: On October 5, 2007, the FAA published a Notice of Proposed
Rulemaking (NPRM) that proposed performance requirements for certain
avionics equipment on aircraft operating in specified classes of
airspace within the United States National Airspace System. The comment
period closed on March 3, 2008. The FAA is reopening the comment period
for an additional 30 days to give the public an opportunity to comment
on recommendations received from an Aviation Rulemaking Committee
established by the Administrator on July 15, 2007.

DATES: Comments must be received on or before November 3, 2008.

ADDRESSES: You may send comments identified by Docket Number FAA-2007-
29305 using any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
     Hand Delivery: Bring comments to Docket Operations in Room
W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    For more information on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of this document.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketsInfo.dot.gov.
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to Docket Operations in Room
W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue,
SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Cindy Nordlie, ARM-108, Office of
Rulemaking, Federal Aviation Administration, 800 Independence Avenue,
SW., Washington, DC 20591, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites interested persons to participate in this
rulemaking by submitting written comments, data, or views on the ARC's
recommendations. The most helpful comments reference a specific portion
of the recommendation and include supporting data. To ensure the docket
does not contain duplicate comments, please send only one copy of
written comments, or if you are filing comments electronically, please
submit your comments only one time.
    We will file in the docket all comments we receive, as well as a
report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. We will consider all comments we
receive on or before the closing date for comments. We will consider
comments filed after the comment period has closed if it is possible to
do so without incurring expense or delay.

Availability of Rulemaking Documents

    You can get an electronic copy using the Internet by:
    (1) Searching the Federal eRulemaking Portal at http://
www.regulations.gov;
    (2) Visiting the Office of Rulemaking's Web page at http://
www.faa.gov/avr/arm/index.cfm; or
    (3) Accessing the Government Printing Office's Web page at http://
www.gpoaccess.gov/fr/index.html.
    You can also get a copy by sending a request to the Federal
Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence
Avenue, SW., Washington, DC 20591, or by calling<PHONE_NUMBER>. Make
sure to identify the docket number, notice number, or amendment number
of this rulemaking.

Background

    On October 5, 2007, the FAA published Notice No. 07-15, Automatic
Dependent Surveillance--Broadcast (ADS-B) Out performance requirements
to support Air Traffic Control (ATC) service (72 FR 56947; Oct. 5,
2007). Comments to that document were to be received on or before
January 3, 2008. On November 19, 2007, the FAA extended the comment
period until March 3, 2008 (72 FR 64966).
    On July 15, 2007, the Administrator established the ADS-B Aviation
Rulemaking Committee (ARC). The ADS-B ARC provides a forum for the U.S.
aviation community to discuss and review the ADS-B NPRM, formulate
recommendations on presenting and structuring an ADS-B mandate, and
consider additional actions that may be necessary to implement those
recommendations. On September 26, 2008, pursuant to its
responsibilities under the charter, the ADS-B ARC submitted to the FAA
specific recommendations addressing the NPRM. These ARC recommendations
have been placed in the docket.
    To give the public an opportunity to comment on the recommendations
received from the ARC, the FAA is reopening the comment period for an
additional 30 days. The purpose of the comment period is to receive
public

comments on the ARC recommendations; the FAA is not reopening the
comment period on the NPRM.

    Issued in Washington, DC, on September 29, 2008.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.
 [FR Doc. E8-23199 Filed 10-1-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1260-1261]
[FR Doc No: 2019-00629]

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

SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-774, OMB Control No. 3235-0727]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rules 400-404 of Regulation Crowdfunding (Intermediaries)

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') has submitted to the Office of Management
and Budget (``OMB'') a request for approval of extension of the
previously approved collection of information provided for in Rules
300-304 of Regulation Crowdfunding.\1\
---------------------------------------------------------------------------

    \1\ See Regulation Crowdfunding, Exchange Act Release No. 76324
(Oct. 30, 2015), 80 FR 71387 (Nov. 16, 2015) (Final Rule)
(``Regulation Crowdfunding'').
---------------------------------------------------------------------------

    The collections of information required under Rules 400 through 404
is mandatory for all funding portals. Form Funding Portal helps ensure
that the Commission can make information about funding portals
transparent and easily accessible to the investing public, including
issuers and obligated persons who engage funding portals; investors who
may purchase securities through offerings on funding portals; and other
regulators. Further, the information provided on Form Funding Portal
expands the amount of publicly available information about funding
portals, including disciplinary history. Consequently, the rules and
forms allows issuers and the investing public, as well as others, to
become more fully informed about funding portals in a more efficient
manner.
    Rule 400 requires each person applying for registration with the
Commission as a funding portal to file electronically with the
Commission Form Funding Portal. Rule 400(a) requires a funding portal
to become a member of a national securities association registered
under Section 15A of the Exchange Act. Rule 400(b) requires a funding
portal to file an amendment to Form Funding Portal if any information
previously submitted on Form Funding Portal becomes inaccurate for any
reason. Rule 400(c) provides that a funding portal can succeed to the
business of a predecessor funding portal upon the successor filing a
registration on Form Funding Portal and the predecessor filing a
withdrawal on Form Funding Portal.
    Rule 400(d) requires a funding portal to promptly file a withdrawal
of registration on Form Funding Portal upon ceasing to operate as a
funding portal. Rule 400(e) states that duplicate originals of the
applications and reports provided for in this section must be filed
with surveillance personnel designated by any registered national
securities association of which the funding portal is a member. Rule
400(f) requires a nonresident funding portal to: (1) Obtain a written
consent and power of attorney appointing an agent for service of
process in the United States; (2) furnish the Commission with the name
and address of its agent for services of process on Schedule C of Form
Funding Portal; (3) certify that it can, as a matter of law, and will
provide the Commission and any registered national securities
association of which it becomes a member with prompt access to its
books and records and can, as a matter of law, and will submit to
onsite inspection and examination by the Commission and any registered
national securities association of which it becomes a member; and (4)
provide the Commission with an opinion of counsel and certify on
Schedule C on Form Funding Portal that the firm can, as a matter of
law, provide the Commission and registered national securities
association of which it becomes a member with prompt access to its
books and records and can, as a matter of law, submit to onsite
inspection and examination by the Commission and any registered
national securities association of which it becomes a member.\2\
---------------------------------------------------------------------------

    \2\ Exchange Act Section 3(h)(1)(C) permits us to impose, as
part of our authority to exempt funding portals from broker
registration, ``such other requirements under [the Exchange Act] as
the Commission determines appropriate.''
---------------------------------------------------------------------------

    Rule 403(a) requires a funding portal to implement written policies
and procedures reasonably designed to achieve compliance with the
federal securities laws and the rules and regulations thereunder
relating to its business as a funding portal. Rule 403(b) provides that
a funding portal must comply with privacy rules. Rule 404 requires all
registered funding portals to maintain certain books and records
relating to their funding portal activities, for not less than five
years, the first two in an easily accessible place. Rule 404(e)
requires funding portals to furnish promptly to the Commission, its
representatives, and the registered national securities association of
which the funding portal is a member true, correct, complete and
current copies of such records of the funding portal that are requested
by the representatives of the Commission and the registered national
securities association.
    The Commission staff estimates that annualized industry burden
would be 17,554.35 hours to comply with Rules 400-404. The Commission
staff estimates that the costs associated with complying with Rules
400-404 are estimated to be approximately a total amount of $308,729.

    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following website: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to: Abate, Lindsay M. EOP/
OMB<EMAIL_ADDRESS>and (ii) Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549, or by
sending an email to<EMAIL_ADDRESS>Comments must be submitted to
OMB within 30 days of this notice.

    Dated: January 29, 2019.
Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-00629 Filed 1-31-19; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 72 (Tuesday, April 14, 2020)]
[Proposed Rules]
[Pages 20621-20624]
[FR Doc No: 2020-07223]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 147

[EPA-HQ-OW-2020-0123; FRL-10007-48-OW]

Wyoming Underground Injection Control Program; Class VI Primacy

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) has received a
complete Underground Injection Control (UIC) program revision package
from the State of Wyoming requesting approval of a revision to the
State's Safe Drinking Water Act (SDWA) section 1422 UIC program to
include Class VI injection well primary implementation and enforcement
authority (primacy). The EPA proposes to approve the application from
Wyoming under the SDWA to implement a UIC program for Class VI
injection wells located within the State, except those on Indian
country. This revision would allow the Wyoming Department of
Environmental Quality to issue UIC permits for geologic carbon
sequestration facilities as Class VI wells and ensure compliance of
Class VI wells with applicable requirements under the UIC program. The
EPA is requesting public comments and announcing that any member of the
public may request a public hearing.

DATES: The application is available for inspection and copying at the
address appearing in the ADDRESSES section of this document. Comments
must be received on or before May 29, 2020. Requests for a public
hearing will be accepted until April 29, 2020.

ADDRESSES: You may send comments, identified by Docket ID No. EPA-HQ-
OW-2020-0123, to the Federal eRulemaking Portal: https://www.regulations.gov/ (our preferred method). Follow the online
instructions for submitting comments.
    Instructions: All submissions received must include the Docket ID
No. EPA-HQ-OW-2020-0123 for this rulemaking. Comments received may be
posted without change to https://www.regulations.gov/, including any
personal information provided. For detailed instructions on sending
comments and additional information on the rulemaking process, see the
``Public Participation'' heading in the SUPPLEMENTARY INFORMATION
section of this document.

Public Hearing

    Only if requested, a public hearing will be held on May 14, 2020
from 9 a.m. to 5 p.m. at 200 West 17th Street, Room 210, Cheyenne,
Wyoming 82002. The hearing details will be provided in a Federal
Register publication if requested.

FOR FURTHER INFORMATION CONTACT: Molly McEvoy, Drinking Water
Protection Division, Office of Ground Water and Drinking Water (4606M),
U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-3754; email address<EMAIL_ADDRESS>or Wendy Cheung,
Underground Injection Control Unit, U.S. Environmental Protection
Agency, Region 8, 1595 Wynkoop Street, MSC 8WD-SDU, Denver, Colorado
80202; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Written Comments

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2020-
0123, at https://www.regulations.gov/ (our preferred method). Once
submitted, comments cannot be edited or removed from the docket. The
EPA may publish any comment received to its public docket. Do not
submit electronically any information you consider to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. If you need to submit CBI, contact Wendy Cheung,
contact information available in the FOR FURTHER INFORMATION CONTACT
section. Multimedia submissions (audio, video, etc.) must be
accompanied by a written comment. The written comment is considered the
official comment and should include discussion of all points you wish
to make. The EPA will generally not consider comments or comment
contents located outside of the primary submission (i.e. on the web,
cloud, or other file sharing system). For additional submission
methods, the full EPA public comment policy, information about CBI or
multimedia submissions, and general guidance on making effective
comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

B. Participation in Public Hearing

    Only if requested, a public hearing will be held on May 14, 2020
from 9:00 a.m. to 5:00 p.m. at 200 West 17th Street, Room 210,
Cheyenne, Wyoming 82001. Requests for a hearing may be sent to Wendy
Cheung, EPA Region 8, 1595 Wynkoop Street, MSC 8WD-SDU, Denver,
Colorado 80202. For additional information regarding the public
hearing, please contact Wendy Cheung at<PHONE_NUMBER> or
<EMAIL_ADDRESS>    The EPA will begin pre-registering speakers for the hearing upon
publication of this document in the Federal Register. To register to
speak at the hearing, please contact Wendy Cheung, EPA Region 8, 1595
Wynkoop Street, MSC 8WD-SDU, Denver, Colorado 80202. For additional
information regarding the public hearing, please contact Wendy Cheung
(303) 312-6242 or<EMAIL_ADDRESS>    The last day to pre-register to speak at the hearing will be May 8,
2020. On

May 13, 2020 the EPA will post a general agenda for the hearing that
will list pre-registered speakers in approximate order at: https://www.epa.gov/uic/underground-injection-control-epa-region-8-co-mt-nd-sd-ut-and-wy#public-notices.
    If the EPA convenes a hearing, the Agency with make every effort to
follow the schedule as closely as possible on the day of the hearing;
however, please plan for the hearing to run either ahead of schedule or
behind schedule. Additionally, requests to speak will be taken the day
of the hearing at the hearing registration desk. The EPA will make
every effort to accommodate all speakers who arrive and register,
although preferences on speaking times may not be able to be fulfilled.
    Each commenter will have five minutes to provide oral testimony.
The EPA encourages commenters to provide the EPA with a copy of their
oral testimony electronically (via email) or in hard copy form.
    The EPA may ask clarifying questions during the oral presentations
but will not respond to the presentations at that time. Written
statements and supporting information submitted during the comment
period will be considered with the same weight as oral comments and
supporting information presented at the public hearing. Commenters
should notify Wendy Cheung at<PHONE_NUMBER> or<EMAIL_ADDRESS>if
they will need specific equipment or if there are other special needs
related to providing comments at the hearings.
    Confirmation of the public hearing will be announced on May 14,
2020. Any updates made to any aspect of the hearing including
registration information and the hearing procedure, should a hearing be
requested, will be posted online at https://www.epa.gov/uic/underground-injection-control-epa-region-8-co-mt-nd-sd-ut-and-wy#public-notices. Please monitor our website to determine if there are
any updates. The EPA does not intend to publish a document in the
Federal Register announcing updates.
    The EPA will not provide audiovisual equipment for presentations
unless we receive special requests in advance. Commenters should notify
Wendy Cheung at<PHONE_NUMBER> or<EMAIL_ADDRESS>when they pre-
register to speak if they will need specific equipment. If you require
the service of a translator or special accommodations such as audio
description, please pre-register for the hearing and describe your
needs by May 7, 2020. We may not be able to arrange accommodations
without advanced notice.

C. Public Participation Activities Conducted by Wyoming

    In 2019, Wyoming held two public hearings with public comment
periods on the State's intent to adopt its Class VI UIC regulations.
The Wyoming Water and Waste Advisory Board (WWAB) held the first public
hearing on June 25, 2019, in Casper, Wyoming. The State accepted public
comments beginning on May 17, 2019, through the adjournment of the
public hearing. The Wyoming Environmental Quality Council held the
second public hearing on November 19, 2019, in Cheyenne, Wyoming. The
State accepted comments on proposed revisions from September 13, 2019
through October 30, 2019. The Wyoming Class VI regulations were signed
by the Governor on January 23, 2020. Documentation of all public
participation activities, including those associated with Class VI UIC
regulations and subsequent revisions that the State proposed before
2019, can be found in EPA's Docket ID No. EPA-HQ-OW-2020-0123.

II. Introduction

    Wyoming received primacy for Class I, III, IV, and V injection
wells under SDWA section 1422 on August 17, 1983, and Class II
injection wells under SDWA section 1425 on December 23, 1982. Wyoming
has applied to the EPA under section 1422 of the SDWA, 42 U.S.C. 300h-
1, for primacy for Class VI injection wells, except those located on
Indian lands. The UIC program revision package from Wyoming includes a
description of the State Underground Injection Control program, copies
of all applicable rules and forms, a statement of legal authority, a
summary and results of Wyoming's public participation activities, and a
Memorandum of Agreement between Wyoming and the EPA Region 8 office.
    This proposed action is based on a legal and technical review of
Wyoming's application as directed in the Code of Federal Regulations
(CFR) at 40 CFR part 145. As a result of this review, the EPA is
proposing to approve Wyoming's application for primacy, based on its
finding that the program meets all applicable requirements for approval
under SDWA section 1422 and the State is capable of administering a
Class VI UIC program in a manner consistent with the terms and purposes
of the SDWA and all applicable regulations.

III. Legal Authorities

    This proposed action would be taken under the authority of sections
1422 and 1450 of the SDWA, 42 U.S.C. 300h-1 and 300j-9.
    Section 1421 of the SDWA requires the Administrator of the EPA to
promulgate minimum requirements for effective State UIC programs to
prevent underground injection activities that endanger underground
sources of drinking water (USDWs). Section 1422 of the SDWA establishes
requirements for states seeking EPA approval of State UIC programs.
    For states that seek approval for UIC programs under section 1422
of the SDWA, the EPA has promulgated a regulation setting forth the
applicable procedures and substantive requirements, codified in 40 CFR
part 145. It includes requirements for state permitting programs (by
reference to certain provisions of 40 CFR parts 124 and 144),
compliance evaluation programs, enforcement authority, and information
sharing.

IV. Wyoming's Application

    On January 31, 2020, Wyoming submitted a program revision
application to add Class VI injection wells to the State's SDWA section
1422 UIC program. The UIC program revision package from Wyoming
includes a description of the State UIC program, copies of all
applicable rules and forms, a statement of legal authority, a summary
and results of Wyoming's public participation activities, and a
Memorandum of Agreement between Wyoming and the EPA's Region 8 office.
The EPA reviewed the application for completeness and simultaneously
performed a technical evaluation of the application materials.

V. EPA's Proposed Action--Incorporation by Reference

    In this action, the EPA is proposing to approve primacy for the
State of Wyoming's Class VI UIC program over Class VI injection wells
in the State, except for those located on Indian lands. Support of this
action is part of the public record in EPA's Docket No. EPA-HQ-OW-2020-
0123. When finalized, this action will amend 40 CFR 147.2550 and
incorporate by reference the EPA-approved state program. The EPA will
continue to administer its UIC program for Class I, II, III, IV, V, and
VI injection wells on Indian lands.
    The provisions of Wyoming's Code that contain standards,
requirements, and procedures applicable to owners or operators of Class
VI UIC wells, as described in the regulatory text, will be incorporated
by reference into 40 CFR 147.2550. Provisions of Wyoming's Code that
contain standards, requirements, and procedures applicable to owners or
operators of Class I, III, IV, and V injection wells

have already been incorporated by reference into 40 CFR 147.2550 but
are being reapproved for this new format. Any provisions incorporated
by reference, as well as all permit conditions or permit denials issued
pursuant to such provisions, will be enforceable by the EPA pursuant to
section 1423 of the SDWA and 40 CFR 147.1(e).
    In order to better serve the public, the EPA is reformatting the
codification of the EPA-approved Wyoming SDWA section 1422 UIC Program
Statutes and Regulations for Well Classes I, III, IV, V, and VI.
Instead of codifying Wyoming Statutes and Regulations as separate
paragraphs, the EPA is now codifying a notebook that contains the EPA-
approved Wyoming Statutes and Regulations for Well Classes I, III, IV,
V, and VI. This notebook will be incorporated by reference into 40 CFR
147.2550 and the documents will be available at https://www.regulations.gov in the docket for this rule. The EPA will also
codify a table listing the EPA-approved Wyoming Statutes and
Regulations for Well Classes I, III, IV, V, and VI in 40 CFR 147.2550.
    The EPA will continue to oversee Wyoming's administration of the
SDWA Class VI program. Part of the EPA's oversight responsibility will
require quarterly reports of non-compliance and annual UIC performance
reports pursuant to 40 CFR144.8. The Memorandum of Agreement between
the EPA and Wyoming, signed by the Regional Administrator on March 20,
2020, makes available to the EPA any information obtained or used by
Wyoming's Class VI UIC program without restriction.

VI. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review 13563

    This action is exempt from review by the Office of Management and
Budget (OMB) because it is a proposed approval of a state UIC program.

B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs

    This proposed action is not an Executive Order 13771 regulatory
action because this action is exempt under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

    This proposed action does not impose any new information collection
burden under the PRA. OMB has previously approved the information
collection activities contained in the existing regulations and has
assigned OMB control number 2040-0042. Reporting or recordkeeping
requirements will be based on Wyoming's UIC Regulations, and the State
of Wyoming is not subject to the PRA.

D. Regulatory Flexibility Act (RFA)

    I certify that this proposed action will not have a significant
economic impact on a substantial number of small entities under the
RFA. In making this determination, the impact of concern is any
significant adverse economic impact on small entities. An agency may
certify that a rule will not have a significant economic impact on a
substantial number of small entities if the rule relieves regulatory
burden, has no net burden or otherwise has a positive economic effect
on the small entities subject to the rule. This proposed action does
not impose any requirements on small entities as this proposed action
would approve a state program.

E. Unfunded Mandates Reform Act (UMRA)

    This proposed action does not contain any unfunded mandate as
described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or
uniquely affect small governments. The proposed action imposes no
enforceable duty on any state, local or tribal governments or the
private sector. EPA's proposed approval of Wyoming's program will not
constitute a federal mandate because there is no requirement that a
state establish UIC regulatory programs and because the program is a
state, rather than a federal program.

F. Executive Order 13132: Federalism

    This proposed action does not have federalism implications. It will
not have substantial direct effects on the states, on the relationship
between the national government and the states, or on the distribution
of power and responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This proposed action does not have tribal implications as specified
in Executive Order 13175. This proposed action contains no federal
mandates for tribal governments and does not impose any enforceable
duties on tribal governments. Thus, Executive Order 13175 does not
apply to this proposed action.

H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that the EPA has reason to believe may disproportionately affect
children, per the definition of ``covered regulatory action'' in
section 2-202 of the Executive Order. This proposed action is not
subject to Executive Order 13045 because it approves a state program.

I. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use

    This proposed action is not subject to Executive Order 13211,
because it is not a significant regulatory action under Executive Order
12866.

J. National Technology Transfer and Advancement Act

    This proposed action does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    The EPA has determined that this proposed action is not subject to
Executive Order 12898 (59 FR 7629, February 16, 1994) because it does
not establish an environmental health or safety standard. This proposed
action is simply proposing to provide that Wyoming has primacy under
the SDWA for the Class VI UIC program, pursuant to which Wyoming will
be implementing and enforcing a state regulatory program that is as
stringent as the existing federal program.

List of Subjects in 40 CFR Part 147

    Environmental protection, Incorporation by reference, Indian lands,
Intergovernmental relations, Reporting and recordkeeping requirements,
Water supply.

Andrew Wheeler,
Administrator.

    For the reasons set out in the preamble, the Environmental
Protection Agency proposes to amend 40 CFR part 147 as follows:

PART 147--STATE, TRIBAL, AND EPA-ADMINISTERED UNDERGROUND INJECTION
CONTROL PROGRAMS

0
 1. The authority citation for part 147 continues to read as follows:

    Authority: 42 U.S.C. 300f et seq.; and 42 U.S.C. 6901 et seq.

0
 2. Amend Sec.  147.2550 by:
0
a. Revising the section heading;
0
b. Revising the introductory text and paragraph (a); and
0
c. Adding paragraph (c) subject heading, and paragraphs (c)(6) and (7),
and (d)(3) and (4).
    The revisions and additions read as follows:

Sec.  147.2550  State-administered program--Class I, III, IV, V and VI
wells.

    The UIC program for Class I, III, IV, and V wells in the State of
Wyoming, except those located on Indian lands, is the program
administered by Wyoming Department of Environmental Quality, approved
by the EPA pursuant to the Safe Drinking Water Act (SDWA) section 1422.
The effective date of this program is August 17, 1983. The UIC Program
for Class VI wells in Wyoming, except those located on Indian lands, is
the program administered by Wyoming Department of Environmental
Quality, approved by the EPA pursuant to SDWA section 1422. Notice of
this approval was published in the Federal Register on [DATE OF FINAL
RULE]; the effective date of this program is [DATE OF FINAL RULE]. This
program consists of the following elements, as submitted to the EPA in
the State's program revision application.
    (a) Incorporation by reference. The requirements set forth in the
state statutes and regulations cited in the notebook entitled ``EPA-
Approved Wyoming SDWA Sec.  1422 Underground Injection Control Program
Statutes and Regulations for Well Classes I, III, IV, V and VI'', dated
March 31, 2020 (contained in Table 1 to paragraph (a) of this section),
are hereby incorporated by reference and made a part of the applicable
UIC program under the SDWA for Wyoming. The Director of the Federal
Register approves this incorporation by reference in accordance with 5
U.S.C. 552(a) and 1 CFR part 51. Copies of the State of Wyoming's
regulations that are incorporated by reference may be inspected at the
U.S. Environmental Protection Agency, Region 8, 1595 Wynkoop Street,
MSC 8WD-SDU, Denver, Colorado 80202; Water Docket, EPA Docket Center
(EPA/DC) EPA West, Room 3334, 1301 Constitution Ave. NW, Washington, DC
20460. If you wish to obtain materials from the EPA Regional Office,
please call<PHONE_NUMBER>; for materials from a docket in the EPA
Headquarters Library, please call the Water Docket at (202) 566-
2426.You may also inspect the materials at the National Archives and
Records Administration (NARA). For information on the availability of
this material at NARA, email<EMAIL_ADDRESS>or go to
www.archives.gov/federal-register/cfr/ibr-locations.html.

  Table 1 to Paragraph (a) EPA-Approved Wyoming SDWA Sec.   1422 Underground Injection Control Program Statutes
                              and Regulations for Well Classes I, III, IV, V and VI
----------------------------------------------------------------------------------------------------------------
                                                                           State
             State citation                      Title/subject        effective date     EPA approval date \1\
----------------------------------------------------------------------------------------------------------------
Wyoming Statutes sections 35-11-101       Wyoming Environmental                 1989  March 6, 1991, 56 FR 9421.
 through 35-11-115, and 35-11-301          Quality Act.
 through 35-11-305.
Water Quality Rules and Regulations,      Regulations for Permit to             1983  May 11, 1984, 49 FR 20197.
 Wyoming Department of Environmental       Construct, Install or
 Quality Chapter III: Regulations for      Modify Public Water
 Permit to Construct, Install or Modify    Supplies, Wastewater
 Public Facilities Capable or, (sic)       Facilities, Disposal
 Causing or Contributing to Pollution.     Systems, Biosolids
                                           Management Facilities,
                                           Treated Wastewater Reuse
                                           Systems and Other
                                           Facilities Capable of
                                           Causing or Contributing
                                           to Pollution.
Water Quality Rules and Regulations,      Quality Standards for                 1980  May 11, 1984, 49 FR 20197.
 Wyoming Department of Environmental       Groundwaters of Wyoming.
 Quality, Chapter VIII: Quality
 Standards for Groundwaters of Wyoming.
Water Quality Rules and Regulations,      Wyoming Groundwater                   1980  May 11, 1984, 49 FR 20197.
 Wyoming Department of Environmental       Pollution Control Permit.
 Quality, Chapter IX: Wyoming
 Groundwater Pollution Control Permit.
Water Quality Rules and Regulations,      Prohibitions of Permits               1989  March 6, 1991, 56 FR 9421.
 Wyoming Department of Environmental       for New Hazardous Waste
 Quality, Chapter XIII: Prohibitions of    Injection Wells.
 Permits for New Hazardous Waste
 Injection Wells.
Land Quality Rules and Regulations,       In Situ Mining............            1981  May 11, 1984, 49 FR 20197.
 Wyoming Department of Environmental
 Quality, Chapter XXI: In Situ Mining.
Water Quality Rules and Regulations,      Class VI Injection Wells              2020  [DATE and CITATION of
 Wyoming Department of Environmental       and Facilities                              FINAL RULE].
 Quality, Chapter XXIV: Class VI           Underground and Injection
 Injection Wells and Facilities            Control Program.
 Underground and Injection Control
 Program.
----------------------------------------------------------------------------------------------------------------
\1\ In order to determine the EPA effective date for a specific provision listed in this table, consult the
  Federal Register publication cited in this column for the particular provision.

* * * * *
    (c) Statements of agreement.
* * * * *
    (6) Memorandum of Agreement addendum between EPA, Region VIII and
Wyoming Department of Environmental Quality, signed by the EPA Regional
Administrator on March 20, 2020.
    (7) Letter from Governor of Wyoming to Regional Administrator, EPA
Region VIII, ``Re: UIC Program Class VI Application,'' January 23,
2020.
    (d) * * *
    (3) ``Attorney General's Statement--``Attorney General's Statement
to Accompany Wyoming's Underground Injection Control Program Class VI
Primacy Application,'' signed by Attorney General and Assistant
Attorney General for the State of Wyoming, January 9, 2020.
    (4) Letter form Attorney General for the State of Wyoming to
Regional Counsel, EPA Region VIII, ``Re: Wyoming Underground Injection
Control Program Class VI Regulations,'' October 25, 2019.
* * * * *
[FR Doc. 2020-07223 Filed 4-13-20; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 190 (Tuesday, October 1, 2013)]
[Notices]
[Pages 60301-60302]
[FR Doc No: 2013-23841]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2013-0041; OMB No. 1660-0118]

Agency Information Collection Activities: Proposed Collection;
Comment Request

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the general public and other Federal agencies to take this opportunity
to comment on a revision of a currently approved information
collection. In accordance with the Paperwork Reduction Act of 1995,
this notice seeks comments concerning the data collection activity
required to prepare the Homeland Security Exercise and Evaluation
Program (HSEEP) After Action Report (AAR) Improvement Plan (IP).

DATES: Comments must be submitted on or before December 2, 2013.

ADDRESSES: To avoid duplicate submissions to the docket, please use
only one of the following means to submit comments:
    (1) Online. Submit comments at www.regulations.gov under Docket ID
FEMA-2013-0041. Follow the instructions for submitting comments.
    (2) Mail. Submit written comments to Docket Manager, Office of
Chief Counsel, DHS/FEMA, 500 C Street SW., Room 8NE, Washington, DC
20472-3100.
    All submissions received must include the agency name and Docket
ID. Regardless of the method used for submitting comments or material,
all submissions will be posted, without change, to the Federal
eRulemaking Portal at http://www.regulations.gov, and will include any
personal information you provide. Therefore, submitting this
information makes it public. You may wish to read the Privacy Act
notice that is available via the link in the footer of
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Daniel St. Pierre, Exercise Program
Specialist, National Exercise Division (NED),<PHONE_NUMBER>. You may
contact the Records Management Division for copies of the proposed
collection of information at facsimile number<PHONE_NUMBER> or email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Presidential Policy Directive 8 (PPD-8:
National Preparedness) issued on March 30, 2011, establishes a National
Preparedness Goal (NPG) that identifies the core capabilities necessary
for preparedness and a National Preparedness System (NPS) to guide
activities that will enable the Nation to achieve the goal. The system
will allow the Nation to track the progress of our ability to build and
improve the capabilities necessary to prevent, protect against,
mitigate the effects of, respond to, and recover from those threats
that pose the greatest risk to the security of the Nation.
    A fully developed National Preparedness System will provide an
integrated approach to preparedness that can be implemented and
measured at all levels of government. The system should provide an all-
of-Nation and whole community approach to preparedness, from
neighborhood organizations to civic groups and private businesses. It
should contain a methodical approach integrated across the preparedness
cycle and link together programs and requirements into a comprehensive
system, driving rational decision-making and allowing for a direct and
defensible assessment of progress against clearly defined objectives.
    A fully implemented National Preparedness System will be based on a
consistent methodology for assessing the threats and hazards facing a
given jurisdiction. The findings of the assessment should then drive
planning factors and all other components of the preparedness cycle
including resource requirements, existing capabilities and capability
gaps, driving investments to close those gaps, making and validating
improvements in capabilities through training and exercising, and
continually assessing progress.
    Section 648(b)(1) of the Post-Katrina Emergency Management Reform
Act of 2006 (6 U.S.C. 748(b)(1)) also provides for these exercises and
states the Administrator ``shall carry out a national exercise program
to test and evaluate the national preparedness goal, National Incident
Management System, National Response Plan, and other related plans and
strategies.'' The Homeland Security Exercise and Evaluation Program
(HSEEP) provides the program structure, multi-year planning system,
tools, and guidance necessary for entities to build and sustain
exercise programs that enhance homeland security capabilities and,
ultimately, preparedness. The Homeland Security Exercise and Evaluation
(HSEEP) After Action Report (AAR) Improvement Plan (IP) provides a
standardized method for reporting the results of preparedness exercises
and identifying, correcting and sharing as appropriate strengths and
areas for improvement. Thus, the HSEEP AAR/IP--in line with the NPG and
the NPS--supports efforts across the whole community that improve our
national capacity to build, sustain, and deliver core capabilities.

Collection of Information

    Title: Homeland Security Exercise and Evaluation Program (HSEEP)
After Action Report (AAR) Improvement Plan (IP)
    Type of Information Collection: Revision of a currently approved
information collection.
    FEMA Forms: FEMA Form 091-0, Homeland Security Exercise and
Evaluation Program (HSEEP) After Action Report (AAR) Improvement Plan
(IP).
    Abstract: The Homeland Security Exercise and Evaluation Program
(HSEEP) After Action Report (AAR) Improvement Plan (IP) collection
provides reporting on the results of preparedness exercises and
provides assessments of the respondent's capabilities so that strengths
and areas for improvement are identified, corrected, and shared as
appropriate prior to a real incident. This information is also required
to be submitted as part of certain FEMA grant programs.
    Affected Public: State, Local or Tribal Government; Federal
Government.
    Number of Respondents: 175.
    Number of Responses: 511.
    Estimated Total Annual Burden Hours: 20,440 hours.
    Estimated Cost: There are no recordkeeping, capital, start-up or
maintenance costs associated with this information collection.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden

of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

    Dated: September 20, 2013.
Charlene D. Myrthil,
Director, Records Management Division, Mission Support Bureau, Federal
Emergency Management Agency, Department of Homeland Security.
[FR Doc. 2013-23841 Filed 9-30-13; 8:45 am]
BILLING CODE 9111-46-P


[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70667-70669]
[FR Doc No: 2023-22460]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3848]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Regulations for In Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collections of information in the
regulations for in vivo radiopharmaceuticals used for diagnosis and
monitoring.

DATES: Submit either electronic or written comments on the collection
of information by December 11, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 11, 2023. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the

public, submit the comment as a written/paper submission and in the
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-N-3848 for ``Regulations for In Vivo Radiopharmaceuticals Used
for Diagnosis and Monitoring.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and
Monitoring--21 CFR Part 315

OMB Control Number 0910-0409--Extension

    This information collection supports our regulations in part 315
(21 CFR part 315) that require manufacturers of diagnostic
radiopharmaceuticals to submit information that demonstrates the safety
and effectiveness of: (1) a new diagnostic radiopharmaceutical or (2) a
new indication for use of an approved diagnostic radiopharmaceutical.
Information about the safety or effectiveness of a diagnostic
radiopharmaceutical enables us to properly evaluate the safety and
effectiveness profiles of such radiopharmaceuticals.
    The information, which is usually submitted as part of a new drug
application (NDA) or biologics license application or as a supplement
to an approved application typically includes, but is not limited to:
(1) nonclinical and clinical data on the pharmacology; (2) toxicology;
(3) adverse events; (4) radiation safety assessments; and (5)
chemistry, manufacturing, and controls. The content and format of an
application for approval of a new drug are set forth in Sec.  314.50
(21 CFR 314.50) and have been approved under OMB control number 0910-
0001.
    In table 1, row 1, we estimate the annual reporting burden for
preparing the safety and effectiveness sections of an application. This
estimate does not include the time needed to conduct studies and
clinical trials or other research from which the reported information
is obtained.
    Based on past submissions of human drug applications, new
indication supplements for diagnostic radiopharmaceuticals, or both, we
estimate that three submissions will be received annually from three
applicants and that 2,000 hours would be spent preparing the portions
of the application that would be affected by this information
collection. We further estimate the total time needed to prepare
complete applications for diagnostic radiopharmaceuticals as
approximately 6,000 hours. This information collection does not impose
any additional reporting burden for safety and effectiveness
information on diagnostic radiopharmaceuticals beyond the estimated
burden of 2,000 hours, because safety and effectiveness information is
already required in Sec.  314.50 and has been approved under OMB
control number 0910-0001. In fact, clarification of our criteria for
the

evaluation of diagnostic radiopharmaceuticals in this information
collection is intended to streamline overall information collection
burdens, particularly for diagnostic radiopharmaceuticals that may have
well-established, low-risk safety profiles by enabling manufacturers to
tailor information submissions and avoid unnecessary clinical trials.
    In table 1, row 2, we estimate the annual reporting burden for
preparing the safety and effectiveness sections of a supplement to an
approved application. This estimate does not include the time needed to
conduct studies and clinical trials or other research from which the
reported information is obtained.
    Based on past submissions of human drug applications, new
indication supplements for diagnostic radiopharmaceuticals, or both, we
estimate that one submission will be received annually. We estimate the
total time needed to prepare complete applications for supplements to
new applications for diagnostic radiopharmaceuticals as approximately
between 500 and 1,000 hours. We calculated the median of this estimate
to arrive at approximately 750 hours. We further estimate that the
total time needed to prepare the portions of the application that would
be affected by this information collection as 750 hours. As previously
stated, this information collection does not impose any additional
reporting burden for safety and effectiveness information on diagnostic
radiopharmaceuticals beyond the estimated burden of 750 hours, because
safety and effectiveness information is already required in Sec.
314.50 and has been approved under OMB control number 0910-0001.
    We estimate the burden of this collection of information as
follows:

       Table 1--Estimated Annual Reporting Burden for NDAs and Supplements to Approved NDAs for Diagnostic
                                            Radiopharmaceuticals \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
 Manufacturers' activity (21 CFR     Number of     responses per   Total annual     burden per      Total hours
            section)                respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
NDAs (Sec.  Sec.   315.4, 315.5,               3               1               3           2,000           6,000
 and 315.6).....................
Supplements to Approved NDAs                   1               1               1             750             750
 (Sec.  Sec.   315.4, 315.5, and
 315.6).........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           6,750
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Since our last OMB approval, our estimated burden for the
information collection reflects an overall decrease of 11 responses
with a corresponding decrease of 12,000 burden hours. We attribute this
adjustment to a decrease in the number of submissions for NDAs for
diagnostic radiopharmaceuticals and new indication supplements for
diagnostic radiopharmaceuticals we received over the past few years.

    Dated: October 5, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22460 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P


Page 1 of 8 U. S. ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM PC Code No. 129106 DP Barcode: D279109 SUBJECT: EFED Review of Documents Relative to Section 24c Special Local Needs Registration of Carbaryl for Use on Oyster Beds.

TO: Anthony Britten, Chemical Review Manager Betty Shackleford, Product Manager Special Review and Reregistration Division FROM: Thomas M. Steeger, Ph. D., Senior Biologist Environmental Risk Branch IV/ EFED (7507C)

Through: Betsy Behl, Branch Chief Environmental Risk Branch IV/ EFED (7507C)

The Environmental Fate and Effects Division (EFED) has completed its review of the materials submitted relative to the Section 24c Special Local Needs registration of carbaryl for use on oyster beds in Willapa Bay and Grays Harbor, Washington, to control ghost shrimp (Callianassa californiensis) and mud shrimp (Upogebia pugettensis). The documents included 1) a report on concentrations of carbaryl and its degradate (1 naphthol) in marine sediments from sites treated with or adjacent areas treated with Sevin (Stonic 1999); 2) a fact sheet on chemicals of special concern in Washington State; 3) a memo from the State of Washington's Department of Ecology's review of data relevant to the environmental effects of applying Sevin ™ to control burrowing shrimp in Willapa Bay and Grays Harbor oyster beds; 4) a copy of the memorandum of agreement between the Washington State Department of Ecology, the Willapa/ Grays Harbor Oyster Growers' Association and other state government and private organizations; and 5) a Washington State Department of Ecology publication entitled Carbaryl Concentrations in Willapa Bay and Recommendations for Water Quality Guidelines (Johnson 2001). Except for more recent studies conducted by Washington State University and the Washington Department of Ecology, much of the older (pre 1996) data had procedural problems that limited the utility of the data. The more recent data indicate that carbaryl residues in the water column were generally at or below an effect threshold of 0.1 ug/ L Although large carbaryl applications can affect water quality in areas distant from spray sites, the Washington Department of Ecology concluded that "no widespread effects from carbaryl would be expected in Wallapa Bay after the end of the [carbaryl] application period."

Carbaryl has been used on approximately 600 acres of Willapa Bay and 200 acres of Grays Harbor at a rate of 7.5 to 10 lbs/ acre/ year since the 1960's. Carbaryl is applied as a wettable powder Page 2 of 8 to tidelands at low low [Spring] tide primarily by helicopter; however, hand spraying is used in some instances. The label restricts aerial applications within 200 feet of a channel or slough; hand spraying is prohibited within 50 feet of a channel or slough.

The data collected and/ or reviewed by the Washington Department of Ecology indicate that carbaryl residues drop below the level of quantitation (< 0.004 ug/ L) approximately 6 weeks after application. While concentrations in nontarget areas immediately following the carbaryl application period are likely to inflict mortality to aquatic organisms, no data are provided to demonstrate that threatened and/ or endangered species (e. g. salmonids) are adversely affected by the treatments to oyster beds.

While these documents provide additional information on the environmental fate and effects of carbaryl in estuarine/ marine environments, EFED's review of Washington's Section 24c petition was based on the required guideline fate and effects data provided by the registrant in support of the reregistration of carbaryl. Although the EFED reregistration eligibility document (RED) for carbaryl does not estimate environmental concentrations for applications directly to tidelands for control of burrowing shrimp in oyster culture, it does discuss the use. Data submitted in support of reregistration (MRID 419826 06) indicate that estuarine/ marine invertebrates will likely be impacted by this route of exposure and that certain species, e. g., Dungenese crab (Cancer magister), may experience 100% mortality in the application area. However, the assessment goes on to note that effects on aquatic invertebrates will likely be temporary as most populations show signs of recovery within 2 months. Additionally, the chapter suggests that carbaryl applications that reduce the potential for drift to nontarget sites, such as direct injection of carbaryl into the sediment, may help mitigate nontarget effects.

Review of Submitted Literature 1) Screening Survey of Carbaryl (Sevin) and 1 naphthol Concentrations in Willapa Bay Sediments The study was undertaken to determine the long term persistence of carbaryl and 1 naphthol; more specifically, the study objectives were to:

° Determine if there are residues of carbaryl and its degradate 1 naphthol in the marine sediments at historically sprayed sites and unsprayed adjacent sites ° Monitor the depletion of these compounds in sediments following applications of Seven ™ . ° Measure concentrations of carbaryl in centrifuged sediment pore water. ° Determine drift potential.

The study was divided into two phases, pre spray and post spray. Sampling was conducted in Willapa Bay in areas deemed to be conducive to carbaryl persistence. Thus, areas with muddy and/ or fine sediments were selected since they were believed to be more likely to retain both carbaryl and 1 naphthol. Sandy sediments were not believed to provide sufficient clay or organic material with which carbaryl and/ or its degradate could sorb. Page 3 of 8 0 500 1000 1500 2000 2500 3000 3500 010 2030 40 50 60 Days after Treatment Carbaryl (ppb)

Figure 1 Average carbaryl concentrations in sediment collected from Willapa Bay at 2, 30 and 60 days after treatment. Pre spray samples were collected from areas that had been sprayed in previous years or were adjacent to areas that had been sprayed in previously. A reference site, Nemah Oyster Reserve, was sampled as an area that had never been sprayed.

Post spray samples were collected immediately following carbaryl treatment and also included areas adjacent to spray sites. Treated sites included areas that had been sprayed in years past in addition to the recent treatment. Sampling was typically conducted 2, 30 and 60 days after treatment (DAT). Sediment samples were collected using a stainless steel 17 cm diameter device that allowed sediment samples to be stratified into 0  2 cm, 2  7.5 cm, and 7.5  15 cm depths. Total organic carbon (TOC) and sediment size were also analyzed. Carbaryl and 1 naphthol residues were measured both in whole sediment and in centrifuged pore water. Quality assurance spiked sediment samples suggest considerable amount of variability in recovery of standards. The results may be negatively biased.

Based on the pre spray study results, all of the historically sprayed sites, adjacent unsprayed sites and the reference site showed no carbaryl or 1 naphthol residues above the detection limit range of 21 to 58 ppb. One sample representing the shallowest area adjacent to historically sprayed beds had trace (29 ppb) residues of carbaryl.

Post spray study results indicate that carbaryl concentrations at sprayed sites ranged from 2,000 to 3,400 ppb by 2 DAT, 180 to 220 ppb by 30 DAT, and 86  120 ppb by 60 DAT (Figure 1). Although, adjacent sites contained as much as 2,000 ppb 2 DAT, residues in sediment at all adjacent sites at 60 DAT were close to detection limits and ranged from 27 to 32 ppb.

Residues for the 1 naphthol ranged from detection limits to as high as 170 ppb at 2 DAT and by 30 DAT all samples had dropped to detection limits (22 to 33 ppb); one sample at 60 DAT contained naphthol at 34 ppb. The report concluded that once carbaryl degrades to 1 naphthol, the degradate appears to readily leave the sediment. It did not however, allow for the fact that the degradate could have been present in deeper reaches of the sediment. At adjacent sites, 1 naphthol ranged as high as 120 ppb 2 DAT and then dropped to below detection limits for the remaining sample periods.

Carbaryl residues in pore water were only detected 60 DAT and ranged from 0.57 to 1.15 ppb. It is difficult to understand though how the limit of detection for pore water was so much lower than that for sediment. Carbaryl was only detected in one sediment pore water sample collected from an adjacent site; the residue was close to the limit of detection at 0.05 ppb. Page 4 of 8 Analyses of sediment grain size and total organic carbon revealed that the clay silt fraction of the post spray sites ranged from 25% to 73% while TOC ranged from 0.58% to 2.07%. Grain size and TOC were strongly correlated (Pearson R 2 range 0.89  0.96); however, there was no correlation between carbaryl residues and TOC.

The study concludes that carbaryl is clearly persistent in treatment areas with residues being detected up to 60 DAT. Additionally, residues in sites adjacent to treated areas indicate that drift does occur. Drift to nontarget sites was attributed to wind, depth of water sampled, and both surface and bottom water currents. Additionally, sediment pore water concentrations exceeded the National Academy of Sciences and Engineering water quality recommendation for carbaryl of 0.06 ppb. Additionally, historic sampling revealed that water column concentrations prior to application ranged as high as 9.2 ppb. The report notes that QA/ QC standards suggested that actual pore water concentrations may be higher than those reported. It is uncertain how much naphthol was present in the water column; however, given that naphthol is more toxic than the parent, the potential affect of the residues on aquatic animals is a legitimate concern.

Finally the report compares the sediment residue data to available toxicity data on carbaryl and concludes that Dungeness crab larvae exposed to carbaryl at concentrations ranging from 0.1 to 10 ppb for 25 days exhibited both molting effects and mortality. Although no formal data were provided on the numbers of organisms affected; the author reports that marine fish and invertebrate mortality was observed 2 DAT. The author proposes that the incidental kills could serve as forage for other fish and foraging birds that would then bioaccumulate carbaryl in their tissues. The report further suggests that indirect effects, such as endocrine disruption and mutagenicity, are not sufficiently characterized and that coupled with direct effects and the potential for bioaccumulation in the food chain, carbaryl and 1 naphthol have the potential to impact threatend and/ or endangered salmon stocks.

The study would have been more thorough had water column concentrations of carbaryl been measured. Given that the compound was applied using both aerial and hand held sprayers, it is difficult to assess the affect of drift relative to application method. It would have also been helpful to know how representative the areas sampled were of the total areas treated in terms of TOC and grain size. Additionally, the limit of detection (25  35 ppb) was not sufficiently low to document residues in sediment and pore water that may have been sufficiently high to effect benthic invertebrates.

2) Chemicals of Special Concern in Washington State Report published by the Washington Department of Ecology provides a brief overview of the environmental fate and effects of carbaryl. Although the overview has footnote numbers, no references were provided; therefore, data supporting carbaryl's characterization could not be verified. The report implies that carbaryl is relatively persistent and that recoveries of aquatic systems exposed to carbaryl have taken as long as 3 years. According to the overview, carbaryl is teratogenic, immunosuppressive, and degrades to carcinogenic compounds. Page 5 of 8 3) Washington Department of Ecology Review of Data Relevant to the Envrionmental Effects of Applying Carbaryl to Control Burrowing Shrimp in Willapa Bay and Grays Harbor Oyster Beds (1987).

The object of the Washington Department of Ecology review was to answer the following questions:

° How long do carbaryl and its primary hydrolysis product 1 naphthol persist in the water column? ° What concentrations of carbaryl and 1 naphthol in water are toxic to marine organisms? ° How long do carbaryl and 1 naphthol persist in the sediments? ° What concentrations of carbaryl and 1 naphthol in sediment are toxic to marine organisms? ° What are the effects on abundance and diversity of infauna? ° What are the effects on abundance and diversity of epifauna? ° What mortality is experienced by Dungenees crab and how does this affect the fishery? ° What mortality is experienced by fish? ° Are birds adversely affected? ° What are the potential ecological impacts of Sevin applications?

While the environmental fate studies on water column and sediment concentrations during and after application of carbaryl showed a decline in carbaryl and 1 naphthol concentrations, much of the data were discounted due to poor detection limits and procedural deficiencies. Open literature reviews of ecological effects revealed that carbaryl is more toxic to crustaceans than to molluscs or fish; however, the degradate 1 naphthol is less toxic to crustaceans than carbaryl but more toxic than the parent to molluscs and fish. Subacute effects of carbaryl were reported at concentrations below the detection limit (1 mg/ L) of most of the monitoring studies reported; the report states that circumstantial evidence suggests the potential for toxic effects at or below 0.1 mg/ L in sediment. Sublethal effects included reduced development of oysters and delayed molting of crab larvae, malformations in fish eggs and adults. Toxicity of carbaryl is reported to increase with temperature.

Although the report fails to conclusively resolve whether carbaryl and its 1 naphthol degradate are sufficiently persistent to effect aquatic life, it notes that the target population of burrowing shrimp take a number of years to recover. However, failure of a treated area to recover may be due to a number of factors and may not result exclusively on the toxicity of carbaryl or its degradate. Page 6 of 8 0 100 200 300 400 500 600 1976 1978 1980 1982 1984 1986 1988 Year Acres Treated Figure 2. Number of acres treated with carbaryl in Willapa Bay over years.

0 10000 20000 30000 40000 50000 60000 0 100 200 300 400 500 600 Number of AcresTreated Number of Crabs Killed Figure 3. Number of crabs killed versus number of acres treated with carbaryl in Willapa Bay. Fisheries data collected on Willapa Bay from 1977 to 1986 show (Figure 2) that the number of acres treated with carbaryl increased each year. And that the number of crabs killed by carbaryl treatment also increased (Figure 3) as the number of acres treated increased. The number of crabs killed was significantly correlated (Pearson Correlation coefficient = 0.72; p > rho = 0.0187) with the number of acres treated. Over the observation period an average of 53 crabs (standard error = 13) were killed per acre.

Follow70000 up studies by the University of Washington that [Dungeness] crab in treated areas are impacted but that further studies are required to establish population level effects in Willapa Bay.

Mortalities to fish were limited to small specimens which were entrapped in shallow pools by the outgoing tide and directly exposed to carbaryl during treatment; however, the reviewed literature did not address the potential for indirect mortality.

Althoughno studieswereconducted,the reportconcludedthatlikelihood ofacuteorchronic effects of carbaryl on birds was remote.

Whether there are broad ecological impacts associated with the use of carbaryl to control burrowing shrimp in Willapa Bay remains an uncertainty. The Environmental Impact Statement concluded that the use of carbaryl by the commercial oyster industry was not expected to cause significant impacts on the estuarine ecosystem when applied at current levels. It based this conclusion on the fact that:

° Carbaryl is not accumulated by any food chain component or transmitted to higher levels in the food chain. ° No chemically active radical group remains to contaminate the estuarine environment. ° Only a small percentage of the total intertidal lands are treated annually; 0.8% in Willapa Bay and 0.3% in Grays Harbor. Page 7 of 8 The report recommends though that further work be conducted to evaluate the persistence of carbaryl and 1 naphthol in sediment and to better document the effects of nontarget mortality.

4) Burrowing Shrimp Integrated Pest Management Memorandum of Agreement The memorandum of agreement (MOA) was established between the Washington State Department of Ecology, Washington State Department of Agriculture, the Washington State Commission on Pesticide Registration, the Washington Department of Fish and Wildlife, the Willapa/ Grays Harbor Oyster Growers Association, the Pacific Coast Shellfish Growers Association and the Pacific Shellfish Institute. The agreement acknowledges that while carbaryl and its 1 naphthol degradate affect nontarget species, are likely transported several hundred yards offsite by tidal action, and may persist for several weeks in the water column and sediments within Willapa Bay/ Grays Harbor, treatment for burrowing shrimp is necessary if economic losses due to diminished oyster harvests are to be avoided. The agreement acknowledges that additional data on the environmental fate and effects of carbaryl are necessary and that alternative methods of control should be explored to mitigate adverse effects especially on threatened/ endangered salmonids. The MOA establishes a process and time for the development of a "sustainable site specific, environmentally sound and ecologically based [integrated] pest management plan for the control of burrowing." The MOA outlines criteria to be met, i. e., demonstration that burrowing shrimp populations have reached a size sufficient to inflict economic losses, before which carbaryl can be applied.

5) Carbaryl Concentrations in Willapa Bay and Recommendations for Water Quality Guidelines.

In the summer of 2000, the Washington State Department of Ecology initiated a study of Willapa Bay. The study was a follow up on the Stonic (1999) study from 1996 to 1997 and concern that carbaryl persisted at a level of 0.7 ug/ L. The objectives of the study were to:

° determine if there is a carbaryl background that persists in Willapa Bay water outside the July to August spray period; ° analyzie carbaryl in other potential sources to Willapa Bay; ° achieve quantitation limits for carbaryl sufficiently low to evaluate the potential for causing toxicity to sensitive marine organisms; ° review the literature on carbaryl's effects on marine organisms and evaluate appropriate water quality guidelines for carbaryl in Willapa Bay.

Results from the study show that carbaryl was frequently detected in Willapa Bay up to 4 days after application to oyster beds and that carbaryl was transported several miles from the site of application. However, the study showed no evidence of carbaryl background in the Willapa Bay water column. Additionally, tributaries and cranberry bog drainages were not significant carbaryl sources. Carbaryl had dropped to levels below quantitation (0.004 ug/ L) approximately 1 month after application Page 8 of 8 Based on a review of toxicity data on 35 marine species, the report recommended 0.06 ug/ L as a probable safe level for marine organisms and a range of 0.1 to 0.7 ug/ L as a potential effects threshold. The value of 0.06 ug/ L was based on a National Academy of Science approach using an EC50 of 6 ug/ L for inhibiting molting in Dungeness crab larvae divided by a 100X safety factor. The data collected from open literature suggests that carbaryl is more toxic to crustaceans and echinoderms than to fish, molluscs, or polychaetes. The study notes that while similar information was not collected on the 1 naphthol degradate, one study has shown it to be roughly twice as toxic to fish as the parent compound but less toxic to crustaceans. Carbaryl was detected at concentrations within the proposed potential effects threshold several miles from treatment areas up to several days following application. The report recommended that future water quality monitoring focus on the period during or immediately after carbaryl applications and that data are collected on carbaryl's 1 naphthol transformation product. Additionally, the report recommends that future effects testing include more sensitive test species and indigenous aquatic species that serve as prey for endangered/ threatened species References Stonic, Cynthia. 1999. Screening Survey of Carbaryl (Sevin ™ ) and 1 naphthol Concentrations in Willapa Bay Sediments. Washington State Department of Ecology. Publication No. 99 323.

Johnson, Art. 2001. Carbaryl Concentrations in Willapa Bay and Recommendations for Water Quality Guidelines. Washington State Department of Ecology. Environmental Assessment Program. Publication No. 01 03 005.