[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21129-21130]
[FR Doc No: 2013-08218]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Orthopaedic and Rehabilitation Devices Panel of the Medical
Devices Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.
    Name of Committee: Orthopaedic and Rehabilitation Devices Panel of
the Medical Devices Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on May 21, 2013, from 8
a.m. to 5 p.m. and on May 22, 2013, from 8 a.m. to 4 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD 20879. The hotel phone number is<PHONE_NUMBER>.
    Contact Person: Jamie Waterhouse, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002,
<EMAIL_ADDRESS>301-796-3063, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.
    Agenda: On May 21, 2013, the committee will discuss and make
recommendations regarding the classification of one of the remaining
preamendments class III devices, shortwave diathermy for all other uses
except for the treatment of malignancies. The class III shortwave
diathermy is a device that applies electromagnetic energy to the body
in a radiofrequency band ranging between 13 megahertz to 27.12
megahertz and is intended for the treatment of medical conditions by
means other than the generation of deep heat within body tissues.
    On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if
made final, would make shortwave diathermy devices for all other uses
class III requiring premarket approval (PMA) applications. In response
to the proposed rule calling for PMAs, FDA received petitions under
section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360e(b)(2)(B)) requesting a change in
classification. The reclassification petitions are available for public
review and comment at www.regulations.gov under docket number FDA-2012-
N-0378. The prior regulatory history of shortwave diathermy for all
other uses has been discussed as part of the proposed rule (77 FR
39953).
    The discussion at the panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to PMA), or reclassify to class I or class II
(subject to premarket notification (510(k))), as directed by section
515(i) of the FD&C Act.
    On May 22, 2013, the committee will discuss and make
recommendations regarding the 515(i) order issued by FDA on April 9,
2009 (Docket No. FDA-2009-M-0101), for one of the remaining
preamendments class III devices, pedicle screw spinal systems, intended
to treat degenerative disc disease and spondylolisthesis other than
either severe spondylolisthesis (grades 3 and 4) at L5-S1, or
degenerative spondylolisthesis with objective evidence of neurologic
impairment. Pedicle screw spinal systems are posterior spinal screw and
rod systems intended as an adjunct to fusion for the treatment of
degenerative disc disease, trauma, deformity, failed previous fusion,
tumor, infection, and inflammatory disorders in the thoracolumbar
spine.
    On July 27, 1998 (63 FR 40025), FDA published a final rule
classifying certain previously unclassified preamendments pedicle screw
spinal systems and reclassifying certain postamendments pedicle screw
spinal systems. On May 22, 2001 (66 FR 28051), FDA published a
technical amendment to the final rule to include an intended use that
was inadvertently omitted from the codified language in the rule. As
described in the summary of revisions in the technical amendment, FDA
changed the intended uses for which pedicle screw spinal systems are
class III from ``all other uses,'' to ``when intended to provide
immobilization and stabilization of spinal segments in the thoracic,
lumbar, and sacral spine as an adjunct to fusion in the treatment of
degenerative disc disease and spondylolisthesis other than either
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative
spondylolisthesis with objective evidence of neurologic impairment.''
Since the technical amendment, FDA has not established an effective
date for the submission of PMAs for pedicle screw spinal systems with
these class III indications for use; consequently, these systems have
been subject to 510(k).
    The discussion at the panel meeting will involve making
recommendations regarding regulatory classification to either reconfirm
to class III (subject to PMA), or reclassify to class I or class II
(subject to 510(k)), as directed by section 515(i) of the FD&C Act.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.

    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before May
13, 2013. Oral presentations from the public will be scheduled between
approximately 12 p.m. and 1 p.m. on May 21, 2013, and between
approximately 10:45 a.m. and 11:45 a.m. on May 22, 2013. Those
individuals interested in making formal oral presentations should
notify the contact person and submit a brief statement of the general
nature of the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before May
3, 2013. Time allotted for each presentation may be limited. If the
number of registrants requesting to speak is greater than can be
reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public hearing session. The contact person will notify
interested persons regarding their request to speak by May 6, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
physical disabilities or special needs. If you require special
accommodations due to a disability, please contact AnnMarie Williams
<EMAIL_ADDRESS>301-796-5966) at least 7 days in
advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: April 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-08218 Filed 4-8-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 143 (Friday, July 24, 2020)]
[Notices]
[Page 44873]
[FR Doc No: 2020-16083]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Effectiveness of Exempt Wholesale Generator and Foreign
Utility Company Status

Wind Wall 1 LLC.....................................        EG20-111-000
Cedar Creek II, LLC.................................        EG20-112-000
Midlands Solar LLC..................................        EG20-113-000
Midlands Lessee LLC.................................        EG20-114-000
Briar Creek Solar 1, LLC............................        EG20-115-000
Elm Branch Solar 1, LLC.............................        EG20-116-000
Huntley Solar, LLC..................................        EG20-117-000
Cubico Huntley Lessee, LLC..........................        EG20-118-000
Richmond Spider Solar LLC...........................        EG20-119-000
Pleinmont Solar 2, LLC..............................        EG20-120-000
Pleinmont Solar 1, LLC..............................        EG20-121-000
Highlander Solar Energy Station 1, LLC..............        EG20-122-000
Highlander IA, LLC..................................        EG20-123-000
Lone Tree Wind, LLC.................................        EG20-124-000
Techren Solar III LLC...............................        EG20-125-000
Techren Solar IV LLC................................        EG20-126-000
Mountain Breeze Wind, LLC...........................        EG20-127-000
Assembly Solar, LLC.................................        EG20-128-000
Bighorn Solar 1, LLC................................        EG20-129-000
IP Aragorn, LLC.....................................        EG20-134-000
IP Juno, LLC........................................        EG20-135-000
IP Titan, LLC.......................................        EG20-136-000
AES ES Alamitos, LLC................................        EG20-137-000
Little Bear Master Tenant, LLC......................        EG20-139-000
Raymond Wind Farm, LLC..............................        EG20-140-000
West Raymond Wind Farm, LLC.........................        EG20-141-000
Boiling Springs Wind Farm, LLC......................        EG20-142-000
Cimarron Bend Wind Project III, LLC.................        EG20-143-000
Aurora Wind Project, LLC............................        EG20-144-000
Taygete Energy Project, LLC.........................        EG20-145-000
Biomasseheizkraftwerk Zolling GmbH..................          FC20-5-000
ENGIE Kraftwerke Farge GmbH & Co KGaA...............          FC20-6-000
ENGIE Kraftwerke Zolling GmbH & Co KGaA.............          FC20-7-000
ENGIE Kraftwerke Wilhemshaven GmbH & Co KG..........          FC20-8-000
Power Plant Rotterdam B.V...........................          FC20-9-000

    Take notice that during the month of June 2020, the status of the
above-captioned entities as Exempt Wholesale Generators or Foreign
Utility Companies became effective by operation of the Commission's
regulations. 18 CFR 366.7(a) (2019).

    Dated: July 10, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-16083 Filed 7-23-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 151 (Tuesday, August 6, 2019)]
[Proposed Rules]
[Pages 38150-38158]
[FR Doc No: 2019-16700]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2015-0174; FRL-9997-42-OW]
RIN 2040-AF94

Withdrawal of Certain Federal Water Quality Criteria Applicable
to Washington

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) proposes to amend
the

federal regulations to withdraw certain human health criteria
applicable to waters in Washington because Washington adopted, and the
EPA approved, human health criteria that the EPA determined are
protective of Washington's designated uses for its waters. The EPA is
providing an opportunity for public comment on this proposed withdrawal
of certain federally promulgated human health criteria. The withdrawal
will enable Washington to implement its EPA-approved human health
criteria, submitted on August 1, 2016, and approved on May 10, 2019, as
applicable criteria for Clean Water Act (CWA or the Act) purposes.

DATES: Comments must be received on or before October 7, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2015-0174, at https://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. 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.
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://www2.epa.gov/dockets/commenting-epa-dockets.
    The EPA is offering two public hearings so that interested parties
may also provide oral comments on this proposed rulemaking. For more
details on the public hearings and to register to attend the hearings,
please visit https://www.epa.gov/wqs-tech/water-quality-standards-regulations-washington.

FOR FURTHER INFORMATION CONTACT: Erica Fleisig, Office of Water,
Standards and Health Protection Division (4305T), Environmental
Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed rule is organized as follows:

I. General Information
    Does this action apply to me?
II. Background
    A. What are the applicable federal statutory and regulatory
requirements?
    B. What are the applicable federal water quality criteria that
the EPA is proposing to withdraw?
III. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Executive Order 13771: Reducing Regulations and Controlling
Regulatory Costs
    C. Paperwork Reduction Act (PRA)
    D. Regulatory Flexibility Act (RFA)
    E. Unfunded Mandates Reform Act (UMRA)
    F. Executive Order 13132: Federalism
    G. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    H. Executive Order 13045: Protection of Children From
Environmental Health and Safety Risks
    I. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    J. National Technology Transfer and Advancement Act of 1995
    K. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

Does this action apply to me?

    This proposed action is proposing to withdraw certain federal human
health criteria that are no longer needed due to the EPA's approval of
corresponding state human health criteria on May 10, 2019. Entities
discharging in Washington waters, citizens, as well as the state of
Washington may be interested in this rulemaking, as after the
completion of this rulemaking Washington's EPA-approved human health
criteria, rather than the federal human health criteria, will be the
applicable water quality standards in Washington waters for CWA
purposes. If you have questions regarding the applicability of this
action to a particular entity, consult the person identified in the
preceding FOR FURTHER INFORMATION CONTACT section.

II. Background

A. What are the applicable federal statutory and regulatory
requirements?

    Consistent with the CWA, the EPA's water quality standards (WQS)
program assigns to states and authorized tribes the primary authority
for adopting WQS.\1\ After states adopt WQS, they must be submitted to
the EPA for review and action in accordance with the CWA. The Act
authorizes the EPA to promulgate federal WQS following the EPA's
disapproval of state WQS or an Administrator's determination that new
or revised WQS are ``necessary to meet the requirements of the Act.''
\2\
---------------------------------------------------------------------------

    \1\ 33 U.S.C. 1313(a), (c).
    \2\ 33 U.S.C. 1313(c)(4).
---------------------------------------------------------------------------

    On September 14, 2015, the EPA proposed a federal rule to establish
updated human health criteria in Washington based on an Administrator's
determination that new or revised WQS were necessary to meet the
requirements of the Act. Specifically, in its 2015 proposed rulemaking,
the EPA considered data representing regional and local fish
consumption that reflected consumption levels much higher than the
National Toxics Rule (NTR) fish consumption rate of 6.5 grams/day, and
accordingly ``determined that the federal human health criteria in the
NTR as applied to Washington no longer protect the relevant designated
uses of Washington's waters.'' \3\ To address the Administrator's
determination pursuant to its section 303(c) authority, the EPA's
proposed rulemaking established human health criteria using a fish
consumption rate of 175 grams/day.\4\ As explained in the EPA's May 10,
2019, letter, the EPA also used all of the inputs from the EPA's
recently updated 2015 CWA section 304(a) recommendations to calculate
the proposed federal criteria.\5\
---------------------------------------------------------------------------

    \3\ Revision of Certain Water Quality Standards Applicable to
Washington, 80 FR 55063, 55066 (September 14, 2015).
    \4\ Id. at 55066-55067.
    \5\ May 10, 2019. Letter and enclosed Technical Support Document
from Chris Hladick, Regional Administrator, EPA Region 10 to Maia
Bellon, Director, Department of Ecology, Re: The EPA's Reversal of
the November 15, 2016 Clean Water Act Section 303(c) Partial
Disapproval of Washington's Human Health Water Quality Criteria and
Decision to Approve Washington's Criteria, at 7.
---------------------------------------------------------------------------

    Following the EPA's 2015 proposed rulemaking, on August 1, 2016,
Washington submitted human health criteria for the EPA's review.\6\
Washington's criteria were based on a fish consumption rate of 175
grams/day and incorporated most of the components of the EPA's updated
2015 CWA section 304(a) recommendations.\7\ By using a fish consumption
rate of 175 grams/day which is consistent with the EPA's proposed
rulemaking,

Washington's human health criteria addressed the basis for the EPA's
2015 Administrator's determination--that it is necessary to adopt new
or revised human health criteria based on a higher fish consumption
rate.
---------------------------------------------------------------------------

    \6\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025.
    \7\ Id.
---------------------------------------------------------------------------

    For the reasons explained in the EPA's 2016 disapproval letter and
final federal rule, the EPA partially disapproved certain human health
criteria that Washington submitted to the EPA.\8\ The EPA's final
federal rule was issued concurrent with its partial disapproval
letter.\9\ In explaining the rationale underlying the partial
disapproval of Washington's August 1, 2016, submittal, the EPA
``agree[d] with Washington's decision to derive the human health
criteria using a FCR of 175 g/day,'' noting that that value was
consistent with the EPA's final federal rule,\10\ however the EPA
disagreed with the risk management decisions the State made during the
development of its human health criteria and its decision not to
incorporate all components of the updated 2015 CWA section 304(a)
recommendations.\11\
---------------------------------------------------------------------------

    \8\ November 15, 2016. Letter (EPA Partial Disapproval Letter)
and enclosed Technical Support Document (Partial Disapproval TSD)
from Daniel D. Opalski, Director, Office of Water and Watersheds,
EPA Region 10 to Maia Bellon, Director, Department of Ecology, Re:
EPA's Partial Approval/Disapproval of Washington's Human Health
Water Quality Criteria and Implementation Tools; 81 FR at 85417
(``Concurrent with this final rule, EPA is taking action under CWA
303(c) to approve in part, and disapprove in part, the human health
criteria submitted by Washington.'').
    \9\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016). Contrary to at least
one comment letter EPA received prior to its May 10, 2019 Decision
to Approve Washington's criteria, the EPA did not provide the State
with 90 days to remedy the partial disapproval, as envisioned in
section 303(c)(3) of the Act. See May 7, 2019 Letter from the Lower
Elwha Klallam Tribe to Administrator Andrew Wheeler, EPA, Re:
Washington State Water Quality Standards at 4.
    \10\ Partial Disapproval TSD at 16.
    \11\ May 10, 2019. Letter and enclosed Technical Support
Document from Chris Hladick, Regional Administrator, EPA Region 10
to Maia Bellon, Director, Department of Ecology, Re: The EPA's
Reversal of the November 15, 2016 Clean Water Act Section 303(c)
Partial Disapproval of Washington's Human Health Water Quality
Criteria and Decision to Approve Washington's Criteria, at 7-9.
---------------------------------------------------------------------------

    Although the EPA promulgated human health criteria for Washington
in the NTR, and subsequently in November 2016, the EPA prefers that
states maintain primary responsibility and establish their own WQS. In
response to a February 21, 2017, petition from several entities asking
the EPA to reconsider the partial disapproval of Washington's August
2016 human health criteria,\12\ the EPA issued a letter on August 3,
2018 stating its intent to reconsider its partial disapproval of
Washington's human health criteria and its subsequent promulgation of
federal criteria.\13\ After a thorough review of the State's 2016
submittal and applicable provisions of the CWA, implementing
regulations and longstanding EPA guidance, on May 10, 2019, the EPA
reconsidered its partial disapproval of Washington's human health
criteria and approved all but two of the criteria that the EPA
previously disapproved.\14\
---------------------------------------------------------------------------

    \12\ February 21, 2017. Petition for Reconsideration of EPA's
Partial Disapproval of Washington's August 1, 2016 submission on
Human Health Water Quality Criteria and Implementation Tools, and
Repeal of the Final Rule Revision of Certain Federal Water Quality
Standards Applicable to Washington, 81 Fed. Reg 85,417 (Nov. 28,
2016) submitted by Northwest Pulp & Paper Association, American
Forest and Paper Association, Association of Washington Business,
Greater Spokane Incorporated, Treated Wood Council, Western Wood
Preservers Institute, Utility Water Act Group and Washington Farm
Bureau.
    \13\ August 3, 2018. Letter from David P. Ross, Assistant
Administrator, Office of Water, EPA to Penny Shamblin, Counsel for
Utility Water Act Group, Re: Petition for Reconsideration of the
Environmental Protection Agency's (EPA) Partial Disapproval of
Washington's Human Health Water Quality Criteria and Implementation
Tools submitted by the State of Washington on August 1, 2016, and
Repeal of the Final Rule Revision of Certain Federal Water Quality
Standards Applicable to Washington.
    \14\ May 10, 2019. Letter and enclosed Technical Support
Document from Chris Hladick, Regional Administrator, EPA Region 10
to Maia Bellon, Director, Department of Ecology, Re: The EPA's
Reversal of the November 15, 2016 Clean Water Act Section 303(c)
Partial Disapproval of Washington's Human Health Water Quality
Criteria and Decision to Approve Washington's Criteria.
---------------------------------------------------------------------------

    As provided in 40 CFR 131.21(c), federally promulgated WQS that are
more stringent than EPA-approved state WQS remain applicable for
purposes of the CWA until the EPA withdraws the federal standards.
Accordingly, the EPA is proposing to amend the federal regulations to
withdraw those federally promulgated human health criteria for which
the EPA has approved Washington's criteria and is providing an
opportunity for public comment on this proposed action.
    The EPA's proposal to withdraw federal criteria following approval
of state criteria is consistent with the federal and state roles
contemplated by the CWA. Consistent with the cooperative federalism
structure of the CWA, once the EPA approves state WQS addressing the
same pollutants for which the EPA has promulgated federal WQS, it is
incumbent on the EPA to withdraw the federal WQS to enable the EPA-
approved state WQS to become the applicable WQS for CWA purposes. That
is what the EPA is proposing to do in this proposed rulemaking. This
proposal is consistent with the EPA's withdrawal of other federally
promulgated WQS following the EPA's approval of state-adopted WQS.\15\
Further, although the state of Washington opposes the EPA withdrawing
the 2016 federal human health criteria, the State remains free to
promulgate the federal standards into state law if it so chooses.\16\
---------------------------------------------------------------------------

    \15\ See e.g., Withdrawal of Certain Federal Water Quality
Criteria Applicable to California: Lead, Chlorodibromomethane, and
Dichlorobromomethane, 83 FR 52163 (Oct. 16, 2018); Water Quality
Standards for the State of Florida's Lakes and Flowing Waters;
Withdrawal, 79 FR 57447 (Sept. 25, 2014); Withdrawal of Certain
Federal Water Quality Criteria Applicable to California, New Jersey
and Puerto Rico, 78 FR 20252 (Apr. 4, 2013).
    \16\ See May 7, 2019. Letter from Maia D. Bellon, Director,
Washington Department of Ecology, to Hon. Andrew R. Wheeler,
Administrator, EPA, Re: EPA's Intention to Reconsider Washington
State's Water Quality Standards for Human Health Criteria.
---------------------------------------------------------------------------

    Shortly before taking its action to approve Washington's human
health criteria, the EPA received several letters expressing concerns
about the EPA revising or repealing the federal criteria and the EPA's
authority under the CWA to ``propose new standards'' for a state.\17\
As described herein, the EPA reconsidered the human health criteria
that Washington submitted to the EPA in 2016 and approved the majority
of those criteria. In light of that approval, the EPA proposes to amend
federal regulations to withdraw the federal criteria the EPA previously
promulgated for Washington. Thus, in this proposed rulemaking, the EPA
is not proposing to promulgate any new or revised federal criteria for
Washington. The EPA's authority to promulgate new or revised federal
criteria is not at issue in this proposal to withdraw the federal
criteria.
---------------------------------------------------------------------------

    \17\ May 8, 2019. Letter from Bob Ferguson, Attorney General,
Washington, to Hon. Andrew R. Wheeler, Administrator, EPA; see also
May 7, 2019. Letter from Maia D. Bellon, Director, Washington
Department of Ecology, to Hon. Andrew R. Wheeler, Administrator,
EPA, Re: EPA's Intention to Reconsider Washington State's Water
Quality Standards for Human Health Criteria; May 7, 2019. Letter
from Frances G. Charles, Chairwoman, to Hon. Andrew R. Wheeler,
Administrator, EPA, Re: Washington State Water Quality Standards
(Human Health Criteria; May 3, 2019. Letter from Justin Parker,
Executive Director, Northwest Indian Fisheries Commission, to Hon.
Andrew R. Wheeler, Administrator, and Mr. David Ross, Assistant
Administrator, Office of Water, EPA, Re: EPA Action Regarding
Washington's Human Health Water Quality Criteria.
---------------------------------------------------------------------------

B. What are the applicable federal water quality criteria that the EPA
is proposing to withdraw?

    This action proposes to amend federal regulations to withdraw all
federal human health criteria promulgated for Washington in November
2016 at 40 CFR 131.45,\18\ with the exception of

criteria for arsenic, methylmercury, and bis(2-chloro-1-methylethyl)
ether. For arsenic, on May 10, 2019, the EPA reaffirmed its November
2016 disapproval of the two criteria Washington submitted for arsenic
(water + organism and organism only), and therefore the federal arsenic
criteria for Washington at 40 CFR 131.45 will remain in place.\19\ For
methylmercury and bis(2-chloro-1-methylethyl) ether, Washington did not
submit criteria for those pollutants and therefore the federally
promulgated criteria are the only criteria in effect for those
pollutants in the State. Although the EPA is proposing to maintain the
federally promulgated criteria for these pollutants, the EPA is also
soliciting comment on whether to withdraw the federally promulgated
criteria for methylmercury and bis(2-chloro-1-methylethyl) ether.
---------------------------------------------------------------------------

    \18\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016).
    \19\ May 10, 2019. Letter and enclosed Technical Support
Document from Chris Hladick, Regional Administrator, EPA Region 10
to Maia Bellon, Director, Department of Ecology, Re: The EPA's
Reversal of the November 15, 2016 Clean Water Act Section 303(c)
Partial Disapproval of Washington's Human Health Water Quality
Criteria and Decision to Approve Washington's Criteria.
---------------------------------------------------------------------------

1. Washington Human Health Criteria That the EPA Approved on May 10,
2019
    On May 10, 2019, the EPA revised its disapproval of 141 of
Washington's human health criteria and approved those criteria. In
addition, the EPA approved four criteria for two pollutants (thallium
and 2,3,7,8-TCDD [dioxin]) that the EPA previously deferred action on
in November 2016.\20\
---------------------------------------------------------------------------

    \20\ May 10, 2019. Letter and enclosed Technical Support
Document from Chris Hladick, Regional Administrator, EPA Region 10
to Maia Bellon, Director, Department of Ecology, Re: The EPA's
Reversal of the November 15, 2016 Clean Water Act Section 303(c)
Partial Disapproval of Washington's Human Health Water Quality
Criteria and Decision to Approve Washington's Criteria.
---------------------------------------------------------------------------

    Because Washington now has 145 additional human health criteria
approved by the EPA for CWA purposes, the EPA has determined that the
141 corresponding federally promulgated human health criteria are no
longer needed in Washington. As noted in the EPA's May 10, 2019,
action, the EPA determined upon reconsideration that Washington's 2016
human health criteria are scientifically sound and protective of the
applicable designated uses in the state.\21\ More information on the
EPA's action to approve Washington's human health criteria upon
reconsideration, including the EPA's approval letter and associated
Technical Support Document, can be accessed at https://www.epa.gov/wqs-tech/water-quality-standards-regulations-washington and in the docket
for this proposed rulemaking.
---------------------------------------------------------------------------

    \21\ May 10, 2019. Letter and enclosed Technical Support
Document from Chris Hladick, Regional Administrator, EPA Region 10
to Maia Bellon, Director, Department of Ecology, Re: The EPA's
Reversal of the November 15, 2016 Clean Water Act Section 303(c)
Partial Disapproval of Washington's Human Health Water Quality
Criteria and Decision to Approve Washington's Criteria.
---------------------------------------------------------------------------

    As explained above, the EPA seeks public comment before withdrawing
the federally promulgated criteria. Although the EPA has determined
that these state criteria are scientifically sound and protective of
the applicable designated uses for waters in the state and otherwise
meet the requirements of the CWA and EPA's implementing regulations at
40 CFR 131, the EPA recognizes that many of Washington's human health
criteria are less stringent than the EPA's federally promulgated
criteria which are based on the EPA's CWA section 304(a) criteria (see
Table 1). However, as explained in the EPA's May 10, 2019, approval and
Technical Support Document, the EPA's CWA section 304(a) criteria are
national recommendations and states retain discretion to adopt
different criteria, that may be less stringent, if the state's criteria
are based on sound science and protect the designated use. In issuing
the May 10, 2019, approval, the EPA determined that Washington's human
health criteria meet the requirements of the CWA and the EPA's
regulations because the State's inputs are based on sound science and
the resulting criteria protect the designated uses.

           Table 1--Comparison of Federally Promulgated Criteria and EPA-Approved Washington Criteria
----------------------------------------------------------------------------------------------------------------
                                              Washington's criteria that EPA        EPA Federally promulgated
                                                 approved on May 10, 2019        criteria at 40 CFR 131.45 that
                                           ------------------------------------   EPA is proposing to withdraw
           Chemical              CAS No.                                       ---------------------------------
                                                 Water &       Organisms only       Water &
                                                organisms       ([micro]g/L)       organisms      Organisms only
                                              ([micro]g/L)                        ([micro]g/L)     ([micro]g/L)
----------------------------------------------------------------------------------------------------------------
1. 1,1,1-Trichloroethane.....        71556  47000...........  160000..........  20000..........  50000.
2. 1,1,2,2-Tetrachloroethane.        79345  0.12............  0.46............  0.1............  0.3.
3. 1,1,2-Trichloroethane.....        79005  0.44............  1.8.............  0.35...........  0.90.
4. 1,1-Dichloroethylene......        75354  1200............  4100............  700............  4000.
5. 1,2,4-Trichlorobenzene....       120821  0.12............  0.14............  0.036..........  0.037.
6. 1,2-Dichlorobenzene.......        95501  2000............  2500............  700............  800.
7. 1,2-Dichloroethane........       107062  9.3.............  120.............  8.9............  73.
8. 1,2-Dichloropropane.......        78875  (*).............  (*).............  (*)............  (*).
9. 1,2-Diphenylhydrazine.....       122667  0.015...........  0.023...........  0.01...........  0.02.
10. 1,2-Trans-                      156605  600.............  5800............  200............  1000.
 Dichloroethylene.
11. 1,3-Dichlorobenzene......       541731  13..............  16..............  2..............  2.
12. 1,3-Dichloropropene......       542756  0.24............  2.0.............  0.22...........  1.2.
13. 1,4-Dichlorobenzene......       106467  460.............  580.............  200............  200.
14. 2,3,7,8-TCDD (Dioxin)....      1746016  0.000000064.....  0.000000064.....  0.000000013....  0.000000014.
15. 2,4,6-Trichlorophenol....        88062  (*).............  (*).............  (*)............  (*).
16. 2,4-Dichlorophenol.......       120832  25..............  34..............  10.............  10.
17. 2,4-Dimethylphenol.......       105679  (*).............  (*).............  (*)............  (*).
18. 2,4-Dinitrophenol........        51285  60..............  610.............  30.............  100.
19. 2,4-Dinitrotoluene.......       121142  (*).............  (*).............  (*)............  (*).
20. 2-Chloronaphthalene......        91587  170.............  180.............  100............  100.
21. 2-Chlorophenol...........        95578  (*).............  (*).............  (*)............  (*).
22. 2-Methyl-4,6-                   534521  7.1.............  25..............  3..............  7.
 Dinitrophenol.
23. 3,3'-Dichlorobenzidine...        91941  (*).............  (*).............  (*)............  (*).
24. 3-Methyl-4-Chlorophenol..        59507  (*).............  (*).............  (*)............  (*).
25. 4,4'-DDD.................        72548  0.000036........  0.000036........  0.0000079......  0.0000079.

26. 4,4'-DDE.................        72559  0.000051........  0.000051........  0.00000088.....  0.00000088.
27. 4,4'-DDT.................        50293  0.000025........  0.000025........  0.0000012......  0.0000012.
28. Acenaphthene.............        83329  110.............  110.............  30.............  30.
29. Acrolein.................       107028  (*).............  (*).............  (*)............  (*).
30. Acrylonitrile............       107131  (*).............  (*).............  (*)............  (*).
31. Aldrin...................       309002  0.0000057.......  0.0000058.......  0.000000041....  0.000000041.
32. alpha-BHC................       319846  0.0005..........  0.00056.........  0.000048.......  0.000048.
33. alpha-Endosulfan.........       959988  9.7.............  10..............  6..............  7.
34. Anthracene...............       120127  3100............  4600............  100............  100.
35. Antimony.................      7440360  12..............  180.............  6..............  90.
36. Arsenic..................      7440382  Disapproved.....  Disapproved.....  N/A............  N/A.
37. Asbestos.................      1332214  (*).............  (*).............  (*)............  (*).
38. Benzene..................        71432  (*).............  (*).............  (*)............  (*).
39. Benzidine................        92875  (*).............  (*).............  (*)............  (*).
40. Benzo(a) Anthracene......        56553  0.014...........  0.021...........  0.00016........  0.00016.
41. Benzo(a) Pyrene..........        50328  0.0014..........  0.0021..........  0.000016.......  0.000016.
42. Benzo(b) Fluoranthene....       205992  0.014...........  0.021...........  0.00016........  0.00016.
43. Benzo(k) Fluoranthene....       207089  0.014...........  0.21............  0.0016.........  0.0016.
44. beta-BHC.................       319857  0.0018..........  0.002...........  0.0013.........  0.0014.
45. beta-Endosulfan..........     33213659  (*).............  (*).............  (*)............  (*).
46. Bis(2-Chloroethyl) Ether.       111444  (*).............  (*).............  (*)............  (*).
47. Bis(2-Chloro-1-                 108601  Not submitted...  Not submitted...  See explanation  See explanation
 Methylethyl) Ether \a\.                                                         below.           below.
48. Bis(2-Ethylhexyl)               117817  0.23............  0.25............  0.045..........  0.046.
 Phthalate.
49. Bromoform................        75252  5.8.............  27..............  4.6............  12.
50. Butylbenzyl Phthalate....        85687  0.56............  0.58............  0.013..........  0.013.
51. Carbon Tetrachloride.....        56235  (*).............  (*).............  (*)............  (*).
52. Chlordane................        57749  0.000093........  0.000093........  0.000022.......  0.000022.
53. Chlorobenzene............       108907  380.............  890.............  100............  200.
54. Chlorodibromomethane.....       124481  0.65............  3...............  0.60...........  2.2.
55. Chloroform...............        67663  260.............  1200............  100............  600.
56. Chrysene.................       218019  1.4.............  2.1.............  0.016..........  0.016.
57. Copper...................      7440508  (*).............  (*).............  (*)............  (*).
58. Cyanide..................        57125  19..............  270.............  9..............  100.
59. Dibenzo(a,h) Anthracene..        53703  0.0014..........  0.0021..........  0.000016.......  0.000016.
60. Dichlorobromomethane.....        75274  0.77............  3.6.............  0.73...........  2.8.
61. Dieldrin.................        60571  0.0000061.......  0.0000061.......  0.000000070....  0.000000070.
62. Diethyl Phthalate........        84662  4200............  5000............  200............  200.
63. Dimethyl Phthalate.......       131113  92000...........  130000..........  600............  600.
64. Di-n-Butyl Phthalate.....        84742  450.............  510.............  8..............  8.
65. Endosulfan Sulfate.......      1031078  9.7.............  (*).............  9..............  (*).
66. Endrin...................        72208  0.034...........  0.035...........  0.002..........  0.002.
67. Endrin Aldehyde..........      7421934  (*).............  (*).............  (*)............  (*).
68. Ethylbenzene.............       100414  200.............  270.............  29.............  31.
69. Fluoranthene.............       206440  16..............  16..............  6..............  6.
70. Fluorene.................        86737  420.............  610.............  10.............  10.
71. Gamma-BHC; Lindane.......        58899  15..............  17..............  0.43...........  0.43.
72. Heptachlor...............        76448  0.0000099.......  0.00001.........  0.00000034.....  0.00000034.
73. Heptachlor Epoxide.......      1024573  0.0000074.......  0.0000074.......  0.0000024......  0.0000024.
74. Hexachlorobenzene........       118741  0.000051........  0.000052........  0.0000050......  0.0000050.
75. Hexachlorobutadiene......        87683  0.69............  4.1.............  0.01...........  0.01.
76. Hexachlorocyclopentadiene        77474  150.............  630.............  1..............  1.
77. Hexachloroethane.........        67721  0.11............  0.13............  0.02...........  0.02.
78. Indeno(1,2,3-cd) Pyrene..       193395  0.014...........  0.021...........  0.00016........  0.00016.
79. Isophorone...............        78591  (*).............  (*).............  (*)............  (*).
80. Methyl Bromide...........        74839  520.............  (*).............  300............  (*).
81. Methylene Chloride.......        75092  16..............  250.............  10.............  100.
82. Methylmercury............     22967926  (Not submitted).  (Not submitted).  See explanation  See explanation
                                                                                below.           below.
83. Nickel...................      7440020  150.............  190.............  80.............  100.
84. Nitrobenzene.............        98953  55..............  320.............  30.............  100.
85. N-Nitrosodimethylamine...        62759  (*).............  (*).............  (*)............  (*).
86. N-Nitrosodi-n-Propylamine       621647  (*).............  (*).............  (*)............  (*).
87. N-Nitrosodiphenylamine...        86306  (*).............  (*).............  (*)............  (*).
88. Pentachlorophenol (PCP)..        87865  0.046...........  0.1.............  0.002..........  0.002.
89. Phenol...................       108952  18000...........  200000..........  9000...........  70000.

90. Polychlorinated Biphenyls          PCB  0.00017.........  0.00017.........  0.000007.......  0.000007.
 (PCBs).
91. Pyrene...................       129000  310.............  460.............  8..............  8.
92. Selenium.................      7782492  120.............  480.............  60.............  200.
93. Tetrachloroethylene......       127184  4.9.............  7.1.............  2.4............  2.9.
94. Thallium.................      7440280  0.24............  0.27............  1.7............  6.3.
95. Toluene..................       108883  180.............  410.............  72.............  130.
96. Toxaphene................      8001352  (*).............  (*).............  (*)............  (*).
97. Trichloroethylene........        79016  0.38............  0.86............  0.3............  0.7.
98. Vinyl Chloride...........        75014  (*).............  0.26............  (*)............  0.18.
99. Zinc.....................      7440666  2300............  2900............  1000...........  1000.
----------------------------------------------------------------------------------------------------------------
\a\ Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
* EPA approved Washington's criteria for these pollutants in November 2016 and therefore did not promulgate
  corresponding federal criteria.

2. Methylmercury and bis(2-chloro-1-methylethyl) ether
    Washington did not submit human health criteria for methylmercury
or bis(2-chloro-1-methylethyl) ether in August 2016. For methylmercury,
Washington explained in its August 2016 submittal documents that it
``decided to defer state adoption of [human health criteria] for
methylmercury at this time, and plans to schedule adoption of
methylmercury criteria and develop a comprehensive implementation plan
after the current rulemaking is completed and has received EPA Clean
Water Act approval.'' \22\ To date, the EPA is not aware of any efforts
Washington has undertaken since 2016 to adopt methylmercury criteria or
develop associated implementation materials, likely because the EPA
promulgated a federal criterion. For bis(2-chloro-1-methylethyl) ether
(which was previously named `bis(2-chloroisopropyl) ether' in the NTR),
Washington explained its position that ``bis(2-chloroisopropyl) ether
does not have a [CWA section] 304(a) national recommended criteria
associated with it, thus the proposed criteria for this chemical were
deleted from the [state's] final rule. Ecology has determined that the
older NTR criteria for bis(2-chloroisopropyl) ether were incorrect, and
were not developed for that particular priority pollutant. Ecology is
adopting criteria only for the priority pollutants for which EPA has
published 304(a) criteria documents.'' \23\
---------------------------------------------------------------------------

    \22\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025. Page 80.
    \23\ Id.
---------------------------------------------------------------------------

    CWA section 303(c)(2)(B) requires states to adopt numeric criteria
for all toxic pollutants listed pursuant to CWA section 307(a)(1) for
which the EPA has published 304(a) criteria, as necessary to protect
the states' designated uses. In 1992, the EPA promulgated the NTR at 40
CFR 131.36, establishing chemical-specific numeric criteria for 85
priority toxic pollutants for 14 states and territories (states),
including Washington, that were not in compliance with the requirements
of CWA section 303(c)(2)(B). In the proposed NTR, the EPA provided
states three options for demonstrating compliance with section
303(c)(2)(B).\24\
---------------------------------------------------------------------------

    \24\ EPA. 1991. Amendments to the Water Quality Standards
Regulation to Establish the Numeric Criteria for Priority Toxic
Pollutants Necessary to Bring All States Into Compliance With
Section 303(c)(2)(B). 56 FR 58420, November 19, 1991. https://www.epa.gov/sites/production/files/2015-06/documents/ntr-proposal-1991.pdf.
---------------------------------------------------------------------------

     Option 1: Adopt statewide numeric criteria in state WQS
for all section 307(a) toxic pollutants for which the EPA has developed
criteria guidance, regardless of whether the pollutants are known to be
present.
     Option 2: Adopt chemical-specific numeric criteria for
priority toxic pollutants that are the subject of the EPA's section
304(a) criteria guidance, where the state determines based on available
information that the pollutants are present or discharged and can
reasonably be expected to interfere with designated uses.
     Option 3: Adopt a procedure to be applied to a narrative
WQS provision prohibiting toxicity in receiving waters. Such procedures
would be used by the state in calculating derived numeric criteria
which must be used for all purposes under section 303(c) of the CWA. At
a minimum, such criteria need to be developed for section 307(a) toxic
pollutants, as necessary to support designated uses, where these
pollutants are discharged or present in the affected waters and could
reasonably be expected to interfere with designated uses.
    For the NTR in Washington, the EPA applied Option 1, explaining
that Washington ``has not adopted numeric criteria for any human health
based criteria for priority pollutants, and EPA has reason to believe
that at least some additional criteria are necessary to comply with
section 303(c)(2)(B).'' \25\ The EPA further explained that it did not
attempt ``to determine the specific priority pollutants and water
bodies that require criteria. However, EPA has determined that at least
some Federal criteria are necessary to protect designated uses. This
determination is supported by information in the record which
demonstrates that priority toxic pollutants are discharged or present
in surface waters at levels that can reasonably be expected to
interfere with State designated uses. For some priority toxic
pollutants, available data clearly demonstrate use impairment and the
need for toxics criteria. For most priority toxic pollutants, however,
available data on the discharge and presence of priority toxic
pollutants are spatially and temporally limited. Nevertheless, EPA
believes that the data for many of these pollutants are sufficient to
satisfy the `reasonable

expectation' test established in section 303(c)(2](B).'' \26\
---------------------------------------------------------------------------

    \25\ Id.
    \26\ Id.
---------------------------------------------------------------------------

    In 2016, Washington explained in its submittal that it was
following Option 1 outlined in the NTR by adopting human health
criteria for all CWA section 307(a) priority toxic pollutants (except
mercury/methylmercury) for which the EPA has developed national
recommended CWA section 304(a) criteria, regardless of whether the
pollutants are known to be present in the state.\27\ The EPA followed
this same approach in 2016 when promulgating federal human health
criteria for Washington.\28\ However, while Washington concluded in
2016 that it wanted to retain the 1992 federally promulgated NTR
criteria for mercury and adopt methylmercury criteria in the future,
the EPA determined that revised criteria for all priority pollutants
were necessary in Washington and therefore promulgated a fish tissue
methylmercury criterion (replacing the NTR water column mercury
criteria) for Washington in 2016. Also, as explained in a memo to the
file in the docket for the 2016 rulemaking,\29\ the EPA disagreed with
Washington's conclusion that bis(2-chloro-1-methylethyl) ether was not
a CWA section 307(a) priority pollutant with associated CWA section
304(a) criteria, and therefore the EPA promulgated criteria for bis(2-
chloro-1-methylethyl) ether at 40 CFR 131.45. Because the EPA followed
the same Option 1 approach in 2016 as it used in the NTR and as
Washington used for its submittal in 2016, the EPA did not specifically
conduct a search for available information indicating that any of the
priority pollutants, including methylmercury and bis(2-chloro-1-
methylethyl) ether, are present or discharged in Washington and can
reasonably be expected to interfere with Washington's designated uses.
---------------------------------------------------------------------------

    \27\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025. Page 20.
    \28\ Revision of Certain Water Quality Standards Applicable to
Washington, 81 FR 85417 (November 28, 2016).
    \29\ EPA. 2016. Bis chem CAS 108-60-1 Memo to File clean.
https://www.regulations.gov/document?D=EPA-HQ-OW-2015-0174-0301.
---------------------------------------------------------------------------

    However, as Washington noted in its 2016 submittal, mercury
contamination is widespread across all 50 states, and Washington has
listed waters as impaired and issued fish advisories due to
mercury.\30\ Additionally, Washington's 2016 cost-benefit analysis for
its human health criteria rulemaking identified mercury as one of the
five most detected chemicals in three discharger categories (wastewater
treatment plants, pulp and paper mills, and resource extraction).\31\
For its final rulemaking in 2016, the EPA identified reasonable
potential for certain industrial dischargers in the state to cause or
contribute to exceedances of the federally promulgated methylmercury
criterion.\32\ Therefore, the available evidence indicates that mercury
is present and discharged in Washington and can reasonably be expected
to interfere with Washington's designated uses.
---------------------------------------------------------------------------

    \30\ Department of Ecology. Washington State Water Quality
Standards: Human health criteria and implementation tools, Overview
of key decisions in rule amendment. August 2016. Ecology Publication
no. 16-10-025. Page 80.
    \31\ Department of Ecology. Final Cost-Benefit and Least-
Burdensome Alternative Analyses. July 2016. Ecology Publication no.
16-10-019. Page 27.
    \32\ Abt Associates. Economic Analysis for Water Quality
Standards Applicable to the State of Washington. October 21, 2016.
https://www.regulations.gov/document?D=EPA-HQ-OW-2015-0174-0300.
---------------------------------------------------------------------------

    The available data on bis(2-chloro-1-methylethyl) ether are more
limited. The EPA did not identify reasonable potential for any
dischargers in Washington to cause or contribute to exceedances of the
federally promulgated criteria for bis(2-chloro-1-methylethyl) ether.
Washington did not evaluate bis(2-chloro-1-methylethyl) ether in its
cost-benefit analysis because it did not include this pollutant in the
state rulemaking. Therefore, the EPA is not aware of evidence on
whether bis(2-chloro-1-methylethyl) ether is present or discharged in
Washington and can reasonably be expected to interfere with
Washington's designated uses.
    Given the information outlined above, the EPA proposes to retain
(i.e., not withdraw) the methylmercury and bis(2-chloro-1-methylethyl)
ether human health criteria promulgated for Washington at 40 CFR 131.45
(81 FR 85417, November 28, 2016). This is consistent with the Option 1
approach and will ensure that Washington has CWA-effective human health
criteria for these two pollutants that may be present in Washington's
waters. The EPA specifically solicits any additional information on
whether mercury/methylmercury and/or bis(2-chloro-1-methylethyl) ether
are present or discharged in Washington and can reasonably be expected
to interfere with Washington's designated uses. Based on the public
comments received, the EPA may consider withdrawing the federally
promulgated criteria for one or both of these pollutants. If the EPA
withdraws the federal criteria for methylmercury and/or bis(2-chloro-1-
methylethyl) ether, there would be no applicable numeric criteria for
CWA purposes. Washington may, at any time adopt and submit to the EPA
human health criteria for either pollutant, consistent with CWA section
303(c) and the EPA's implementing regulations at 40 CFR part 131.

III. Statutory and Executive Order Reviews

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

    It has been determined that this proposed rule is not a
``significant regulatory action'' under the terms of Executive Order
12866 (58 FR 51735, October 4, 1993) and is, therefore, not subject to
review under Executive Orders 12866 and 13563 (76 FR 3821, January 21,
2011). The proposed rule does not establish any requirements directly
applicable to regulated entities or other sources of toxic pollutants.

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

    This action is expected to be an Executive Order 13771 deregulatory
action.

C. Paperwork Reduction Act (PRA)

    This action does not impose any new information-collection burden
under the Paperwork Reduction Act (PRA) because it is administratively
withdrawing federal requirements that are no longer needed in
Washington. It does not include any information collection, reporting,
or recordkeeping requirements. The Office of Management and Budget
(OMB) has previously approved the information collection requirements
contained in the existing regulations 40 CFR part 131 and has assigned
OMB control number 2040-0286.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the Regulatory
Flexibility Act (RFA). This action will not impose any requirements on
small entities. Small entities, such as small businesses or small
governmental jurisdictions, are not directly regulated by this rule.

E. Unfunded Mandates Reform Act (UMRA)

    This action contains no unfunded federal mandates under the
provisions of Title II of the Unfunded Mandates Reform Act of 1995
(UMRA), 2 U.S.C. 1531-1538, and does not significantly or uniquely
affect small governments. As

this action proposes to withdraw certain federally promulgated
criteria, the action imposes no enforceable duty on any state, local,
or tribal governments, or the private sector.

F. Executive Order 13132: Federalism

    This 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. This rule
imposes no regulatory requirements or costs on any state or local
governments. Thus, Executive Order 13132 does not apply to this action.

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

    This action may have tribal implications. However, it will neither
impose substantial direct compliance costs on federally recognized
tribal governments, nor preempt tribal law. In the state of Washington,
there are 29 federally recognized Indian tribes.
    The EPA initiated consultation with federally recognized tribal
officials under the EPA's Policy on Consultation and Coordination with
Indian tribes early in the process of developing this proposed rule to
allow meaningful and timely input into its development. The EPA
initially offered tribal consultation on this rule making on May 21,
2019. EPA staff then offered two informational calls for tribal staff
on June 4 and 5, 2019, to assist tribes with the consultation process,
including the tribes' decisions on whether to accept the offer to
consult. Many tribes have expressed dissatisfaction that EPA did not
offer consultation prior to its May 10, 2019, decision and have
questioned how meaningful the EPA's offer for consultation is on this
rule making as a result. To the extent tribes have been interested in
consulting on this rulemaking, they have emphasized the importance of
consultation occurring prior to publication of a proposed rule. A
number of tribes expressed the need for more time prior to the proposed
rule publication to conduct consultation, for more information provided
in advance to prepare for and engage in consultation and for the actual
EPA decision-maker to be present.
    Input received from tribes during consultation, meetings and
through letters received thus far, indicates tribes are opposed to this
proposed action. Tribes have raised health, economic and implementation
concerns, as well as the EPA's trust responsibility, treaty obligations
and consultation practices. While the EPA acknowledges it may not
satisfy the tribal consultation expectations of each tribe, the EPA
will continue to offer the opportunity to consult up to the point of
finalizing this rule and will evaluate the input received before making
a final decision.

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

    This rule is not subject to Executive Order 13045, because it is
not economically significant as defined in Executive Order 12866, and
because the environmental health or safety risks addressed by this
action do not present a disproportionate risk to children.

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

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution, or use of energy.

J. National Technology Transfer and Advancement Act of 1995

    This proposed rulemaking does not involve technical standards.

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

    Executive Order 12898 (59 FR 7629, February 16, 1994) establishes
federal executive policy on environmental justice. Its main provision
directs federal agencies, to the greatest extent practicable and
permitted by law, to make environmental justice part of their mission
by identifying and addressing, as appropriate, disproportionately high
and adverse human health or environmental effects of their programs,
policies, and activities on minority populations and low-income
populations in the United States. The EPA concludes that this action
does not have disproportionately high and adverse human health or
environmental effects on minority populations, low income populations
and/or indigenous peoples, as specified in Executive Order 12898 (59 FR
7629, February 16, 1994). The EPA has previously determined that
Washington's adopted and EPA-approved criteria are protective of human
health.

List of Subjects in 40 CFR Part 131

    Environmental protection, Indians-lands, Intergovernmental
relations, Reporting and recordkeeping requirements, Water pollution
control.

    Dated: July 23, 2019.
Andrew R. Wheeler,
Administrator.

    For the reasons set forth in the preamble, the EPA proposes to
amend 40 CFR part 131 as follows:

PART 131--WATER QUALITY STANDARDS

0
1. The authority citation for part 131 continues to read as follows:

    Authority: 33 U.S.C. 1251 et seq.

Subpart D--Federally Promulgated Water Quality Standards

0
2. Amend Sec.  131.45 by revising paragraph (b) to read as follows:

Sec.  131.45   Revision of certain Federal water quality criteria
applicable to Washington.

* * * * *
    (b) Criteria for priority toxic pollutants in Washington. The
applicable human health criteria are shown in Table 1 to paragraph (b).

                                                                 Table 1 to Paragraph (b)--Human Health Criteria for Washington
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                          A                                                                        B                                                                     C
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                       Cancer Slope                                                    Bio-            Bio-
                                                        factor, CSF         Relative source          Reference     accumulation    concentration      Water &
                Chemical                   CAS No.       (per mg/       contribution,  RSC (-)    dose, RfD (mg/   factor  (L/kg   factor  (L/kg     organisms     Organisms  only  ([micro]g/L)
                                                       kg[middot]d)                                kg[middot]d)       tissue)         tissue)      ([micro]g/L)
                                                                (B1)  (B2)                                  (B3)            (B4)            (B5)            (C1)  (C2)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1. Arsenic **..........................      7440382            1.75  ..........................  ..............  ..............              44       \a\ 0.018  \a\ 0.14.
2. Bis(2-Chloro-1-Methylethyl) Ether *.       108601  ..............  0.50                                  0.04              10  ..............             400  900.
3. Methylmercury.......................     22967926  ..............  2.7E-05                             0.0001  ..............  ..............  ..............  \b\ 0.03 (mg/kg).
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\a\ This criterion refers to the inorganic form of arsenic only.
\b\ This criterion is expressed as the fish tissue concentration of methylmercury (mg methylmercury/kg fish). See Water Quality Criterion for the Protection of Human Health: Methylmercury (EPA-
  823-R-01-001, January 3, 2001) for how this value is calculated using the criterion equation in the EPA's 2000 Human Health Methodology rearranged to solve for a protective concentration in
  fish tissue rather than in water.
* Bis(2-Chloro-1-Methylethyl) Ether was previously listed as Bis(2-Chloroisopropyl) Ether.
** These criteria were promulgated for Washington in the National Toxics Rule at 40 CFR 131.36, and are moved into 40 CFR 131.45 to have one comprehensive human health criteria rule for
  Washington.

* * * * *
[FR Doc. 2019-16700 Filed 8-5-19; 8:45 am]
 BILLING CODE 6560-50-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

11/6/13

MEMORANDUM

SUBJECT: Test Procedure Meeting with the Alliance of Automobile
Manufacturers and the Global Automakers

FROM: Christopher Laroo

TO:  EPA Docket # EPA-HQ-OAR-2009-0472

This memo documents a meeting held on 11/6/13 between representatives of
the Alliance of Automobile Manufacturers, Global Automakers, ARB, and
EPA to discuss light-duty vehicle test procedures in 40 CFR parts 85,
86, 600, 1065 and 1066.  The meeting attendees are enclosed.

The discussion topics included testing on partial hybrid electric
vehicles (PHEVs) and parts 86, 1065, and 1066.


[Federal Register Volume 82, Number 238 (Wednesday, December 13, 2017)]
[Notices]
[Page 58675]
[FR Doc No: 2017-26844]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Random Drug and Alcohol Testing Percentage Rates of Covered
Aviation Employees for the Period of January 1, 2018, Through December
31, 2018

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice.

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

SUMMARY: The FAA has determined that the minimum random drug and
alcohol testing percentage rates for the period January 1, 2018,
through December 31, 2018, will remain at 25 percent of safety-
sensitive employees for random drug testing and 10 percent of safety-
sensitive employees for random alcohol testing.

FOR FURTHER INFORMATION CONTACT: Ms. Vicky Dunne, Office of Aerospace
Medicine, Drug Abatement Division, Program Policy Branch (AAM-820),
Federal Aviation Administration, 800 Independence Avenue SW, Room 806,
Washington, DC 20591; Telephone<PHONE_NUMBER>.
    Discussion: Pursuant to 14 CFR 120 .109(b), the FAA Administrator's
decision on whether to change the minimum annual random drng testing
rate is based on the reported random drug test positive rate for the
entire aviation industry. If the reported random drug test positive
rate is less than 1.00%, the Administrator may continue the minimum
random drug testing rate at 25%. In 2016, the random drug test positive
rate was 0.610%. Therefore, the minimum random drug testing rate will
remain at 25% for calendar year 2018.
    Similarly, 14 CFR 120.2 17(c), requires the decision on the minimum
annual random alcohol testing rate to be based on the random alcohol
test violation rate. If the violation rate remains less than 0.50%, the
Administrator may continue the minimum random alcohol testing rate at
10%. In 2016, the random alcohol test violation rate was 0.121%.
Therefore, the minimum random alcohol testing rate will remain at 10%
for calendar year 2018.

SUPPLEMENTARY INFORMATION: If you have questions about how the annual
random testing percentage rates are determined please refer to the Code
of Federal Regulations Title 14, section 120 .109(b) (for drug
testing), and 120.217(c) (for alcohol testing).

Michael A. Berry,
Federal Air Surgeon.
[FR Doc. 2017-26844 Filed 12-12-17; 8:45 am]
 BILLING CODE P


[Federal Register: February 2, 2010 (Volume 75, Number 21)]
[Notices]
[Page 5318-5320]
[DOCID:fr02fe10-62]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0684; FRL-8809-8]

Notice of Receipt of Requests to Voluntarily Cancel Certain
Pesticide Registrations

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In accordance with section 6(f)(1) of the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA), as amended, EPA is issuing a
notice of receipt of request by registrants to voluntarily cancel
certain pesticide registrations.

DATES: Unless a request is withdrawn by or March 4, 2010 for
registrations for which the registrant requested a waiver of the 180-
day comment period, orders will be issued canceling these
registrations. The Agency will consider withdrawal requests postmarked
no later than March 4, 2010, whichever is applicable. Comments must be
received on or before March 4, 2010, for those registrations where the
180-day comment period has been waived.

ADDRESSES: Submit your comments and your withdrawal request, identified
by docket identification (ID) number EPA-HQ-OPP-2009-0684 by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2009-0684. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification,

EPA may not be able to consider your comment. Electronic files should
avoid the use of special characters, any form of encryption, and be
free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Daniel Peacock, Registration Division,
Office of Pesticide Programs, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(703) 305-5407; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this
action may be of particular interest to persons who produce or use
pesticides, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the information in this notice, consult the person listed
under FOR FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1.  Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2.  Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
     ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. What Action is the Agency Taking?

    This notice announces receipt by the Agency of applications from
registrants to cancel one pesticide product with several registrations
under section 3 or 24(c) of FIFRA. This product is listed in sequence
by registration number (or company number and 24(c) number) in Table 1
of this unit:

     Table 1.--Registrations with Pending Requests for Cancellation
------------------------------------------------------------------------
       Registration No.            Product Name        Chemical Name
------------------------------------------------------------------------
NE-060001                       Rozol Prairie Dog  Chlorophacinone
                                 Bait
------------------------------------------------------------------------
CO-060009                       Rozol Prairie Dog  Chlorophacinone
                                 Bait
------------------------------------------------------------------------
KS-070003                       Rozol Prairie Dog  Chlorophacinone
                                 Bait
------------------------------------------------------------------------
WY-070005                       Rozol Prairie Dog  Chlorophacinone
                                 Bait
------------------------------------------------------------------------
TX-070008                       Rozol Prairie Dog  Chlorophacinone
                                 Bait
------------------------------------------------------------------------
OK-080002                       Rozol Prairie Dog  Chlorophacinone
                                 Bait
------------------------------------------------------------------------

    Unless a request is withdrawn by the registrant within 180 days of
publication of this notice, orders will be issued canceling all of
these registrations. Users of this pesticide or anyone else desiring
the retention of a registration should contact the applicable
registrant directly during this 180-day period.
    Table 2 of this unit includes the name and address of record for
all registrants of the product in Table 1 of this unit.

         Table 2.--Registrants Requesting Voluntary Cancellation
------------------------------------------------------------------------
            EPA Company No.                  Company Name and Address
------------------------------------------------------------------------
7173                                     Liphatech
                                         3600 West Elm St.,
                                         Milwaukee, WI 53209
------------------------------------------------------------------------

III. What is the Agency's Authority for Taking this Action?

    Section 6(f)(1) of FIFRA provides that a registrant of a pesticide
product may at any time request that any of its pesticide registrations
be canceled. FIFRA further provides that, before acting on the request,
EPA must publish a notice of receipt of any such request in the Federal
Register. Thereafter, the Administrator may approve such a request.

IV. Procedures for Withdrawal of Request

    Registrants who choose to withdraw a request for cancellation must
submit such withdrawal in writing to the person listed under FOR
FURTHER INFORMATION CONTACT, postmarked before August 2, 2010. This
written withdrawal of the request for cancellation will apply only to
the applicable FIFRA section 6(f)(1) request listed in this notice. If
the product(s) have been subject to a previous cancellation action, the
effective date of cancellation and all other provisions of any earlier
cancellation action are controlling. The withdrawal request must also
include a commitment to pay any reregistration fees due, and to fulfill
any applicable unsatisfied data requirements.

V. Provisions for Disposition of Existing Stocks

    The effective date of cancellation will be the date of the
cancellation order. The orders effecting these requested cancellations
will generally permit a registrant to sell or distribute existing
stocks for 1 year after the date the cancellation request was received.
This policy is in accordance with the Agency's statement of policy as
prescribed in the Federal Register of June 26, 1991 (56 FR 29362) (FRL-
3846-4). Exceptions to this general rule will be made if a product
poses a risk concern, or is in noncompliance with reregistration
requirements, or is subject to a data call-in. In all cases, product-
specific disposition dates will be given in the cancellation orders.
    Existing stocks are those stocks of registered pesticide products
which are currently in the United States and which have been packaged,
labeled, and released for shipment prior to the effective date of the
cancellation order. Unless the provisions of an earlier order apply,
existing stocks already in the hands of dealers or users can be
distributed, sold, or used legally until they are exhausted, provided
that such further sale and use comply with the EPA-approved label and
labeling of the affected product. Exception to these general rules will
be made in specific cases when more stringent restrictions on sale,
distribution, or use of the products or their ingredients have already
been imposed, as in a special review action, or where the Agency has
identified significant potential risk concerns associated with a
particular chemical.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: January 26, 2010
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs

[FR Doc. 2010-2143 Filed 2-1-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 82, Number 21 (Thursday, February 2, 2017)]
[Notices]
[Pages 9083-9085]
[FR Doc No: 2017-02181]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. IC-32457; File No. 812-14149]

Allstate Assurance Company, et al.; Notice of Application

January 27, 2017.

AGENCY: Securities and Exchange Commission (``SEC'' or ``Commission'').

ACTION: Notice of Application for an order pursuant to Section 6(c) of
the Investment Company Act of 1940, as amended (the ``1940 Act'' or
``Act''), exempting Allstate Assurance Company Separate Account B from
all provisions of the Act, subject to certain conditions.

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

Applicants: Allstate Assurance Company (the ``Company'') and Allstate
Assurance Company Separate Account B (the ``Separate Account,'' and
together with the Company, the ``Applicants'').

Summary of Application: The Applicants seek an order pursuant to
Section 6(c) of the 1940 Act, exempting the Separate Account from all
provisions of the 1940 Act, subject to certain conditions.

DATES:  Filing Date: The application was filed on April 12, 2013, and
amended and restated on February 18, 2014, August 20, 2015 and November
21, 2016.

Hearing or Notification of Hearing: An order granting the application
will be issued unless the Commission orders a hearing. Interested
persons may request

a hearing by writing to the Secretary of the Commission and serving
Applicants with a copy of the request, personally or by mail. Hearing
requests should be received by the Commission by 5:30 p.m. on February
21, 2017, and should be accompanied by proof of service on Applicants
in the form of an affidavit or, for lawyers, a certificate of service.
Hearing requests should state the nature of the requester's interest,
the reason for the request, and the issues contested. Persons who wish
to be notified of a hearing may request notification by writing to the
Secretary of the Commission.

ADDRESSES: Secretary, SEC, 100 F Street NE., Washington, DC 20549-1090.
Applicants: Allstate Assurance Company and Allstate Assurance Company
Separate Account B, 3100 Sanders Road, Suite J5B, Northbrook, IL 60062.

FOR FURTHER INFORMATION CONTACT: Sally Samuel, Branch Chief, Disclosure
Review and Accounting Office, Division of Investment Management, at
(202) 551-6795.

SUPPLEMENTARY INFORMATION: The following is a summary of the
application. The complete application may be obtained via the
Commission's Web site by searching for the file number, or for an
applicant using the company name box, at http://www.sec.gov/search/search.htm, or by calling<PHONE_NUMBER>.

I. Applicants' Representations

    1. The Separate Account was established as a managed separate
account of the Company on August 21, 1967, for the purpose of funding
certain variable annuity contracts (the ``Contracts''). The Separate
Account is registered as an open-end management investment company
under the Act (File No. 811-01525).
    2. The Separate Account has retained Provident Investment
Management, LLC, to serve as the investment adviser to the Separate
Account and The Variable Annuity Life Insurance Company and The Paul
Revere Life Insurance Company to provide administrative services to the
Separate Account. A Board of Managers, a majority of which consists of
persons who are independent of the Separate Account within the meaning
of the Act, currently oversees the Separate Account's operations.
    3. The Separate Account is one of two investment options available
under the Contracts. The other investment option under the Contracts is
the Company's general account, which pays a fixed rate of interest
(``Fixed Account''). As of September 30, 2016, there were a total of
125 individual Contract owners, only 47 of whom were invested in the
Separate Account. Contract owners may transfer account assets between
the Fixed Account and the Separate Account but only once every 12
months.
    4. Redemptions have significantly reduced the Separate Account's
assets over the past decade and are likely to continue notwithstanding
any positive investment performance that may result in a net increase
in the Separate Account's assets. As of September 30, 2016, the
Separate Account had approximately $800,000 in total net assets.
    5. The public offering of the Contracts under the Securities Act of
1933 (``Securities Act'') was initially registered in 1967 (File No. 2-
27135). The Company discontinued the sale of new Contracts in 1984.
Although the Contracts allow Contract owners to make additional
contributions, the Company has not received an additional contribution
under the Contracts since November 2006, which was allocated to the
Fixed Account. No contributions or transfers have been allocated to the
Separate Account since 2002. The Company has no intention of offering
the Contracts to new purchasers, and conducts no solicitation or
marketing activities with respect to the Contracts.

II. Applicants' Legal Analysis

    1. Applicants respectfully request that the Commission, pursuant to
Section 6(c) of the Act, issue an Order granting an exemption from all
provisions of the Act, subject to the conditions set out in Section
III, below. Applicants believe, based on the grounds set out in the
application, that the requested exemption meets the standards of
Section 6(c) of the Act.
    2. Section 6(c) of the Act authorizes the Commission to
``conditionally or unconditionally exempt any person, security, or
transaction, or any class or classes of persons, securities, or
transactions, from the provisions of [the Act] or of any rule or
regulation thereunder, if and to the extent that such exemption is
necessary or appropriate in the public interest and consistent with the
protection of investors and the purposes fairly intended by the policy
and provisions of [the Act.]''
    3. Applicants believe that the requested exemption is appropriate
in the public interest and consistent with the protection of investors
and the purposes fairly intended by the policy and provisions of the
Act. Section 3(c)(1) of the Act makes clear that Congress intended to
exclude from the Act entities in which there is no significant public
interest.\1\ As noted above, only 47 individual beneficial owners are
currently invested in the Separate Account, well below the 100 person
limit of Section 3(c)(1). In addition, the Company discontinued the
sale of new Contracts in 1984. Likewise, the Separate Account has not
received any additional Contract owner money in over a decade. No
salesperson is engaged in any solicitation or marketing activity with
respect to the Contracts or the Separate Account, and no compensation
is being paid for any such activity. The Company has no intention of
offering the Contracts to new purchasers, or encouraging any
investments in the Separate Account and will not do so if the Order is
granted. Although the terms and conditions of the Contracts permit
Contract owners to make future allocations to or investments in the
Separate Account, Applicants assert that the Separate Account's
historical experience strongly suggests that the likelihood of
receiving any such allocation or investment is remote.
---------------------------------------------------------------------------

    \1\ H.R. Rep. No. 96-1341 at 35 (1980); S. Rep. No. 96-958 at 20
(1980). (``Section 3(c)(1) was intended to exclude from the Act
private companies in which there is no significant public interest
and which are therefore not appropriate subjects of federal
regulation.'')
---------------------------------------------------------------------------

    4. In addition, Applicants state that Contract owners do not need
the protections afforded by the Act. Applicants assert that Contract
owners are adequately protected by the fact that their longstanding
relationship with the Company of over 30 years is established by the
terms and conditions of the Contracts, which may not be changed without
Contract owner approval except where permitted or required by
applicable law. The Contracts, among other things, fix the fees and
charges (including management fees) associated with the Separate
Account, thus distinguishing the Separate Account from mutual funds
whose expenses can change periodically. The Contracts also confer upon
owners the right to receive at least annually a statement (a)
reflecting the investment results for the prior year, (b) listing the
investments of the Separate Account as of the date of the statement,
and (c) reflecting the value of the accumulation units credited to the
Contracts. Moreover, after the date of the Order requested by the
application, Applicants will provide Contract owners with annual
audited financial statements of the Company and the Separate Account
pursuant to proposed condition 5 described below. In addition, the
Contracts are governed by and administered according to state

insurance law, which requires that the Company maintain in the Separate
Account assets with a value at least equal to the reserves and other
contract liabilities with respect to the Separate Account; that the
income, gains and losses, realized or unrealized, from assets allocated
to the Separate Account be credited to or charged against the Separate
Account, without regard to other income, gains or losses of the
Company; and that assets of the Separate Account equal to the reserves
and other contract liabilities with respect to the Separate Account not
be charged with liabilities arising out of any other business the
Company may conduct. Furthermore, the requested relief would be subject
to the other conditions described in Section III, below.
    5. Applicants state that there is very little Contract owner
interest in the Separate Account. The last time a premium was received
under a Contract was in November 2006, and the last time a premium or
transfer was allocated to the Separate Account was in 2002. The
Separate Account's assets have been declining due to redemptions over
the past decade and are likely to continue to decline as the result of
redemptions.
    6. Applicants maintain that granting the requested relief would
enable Applicants to avoid the difficulties of trying to efficiently
manage the Separate Account in compliance with the diversification and
other requirements of the Act as assets dwindle down to zero. Further,
Applicants assert that granting the requested relief would enable
Applicants to avoid the significant ongoing legal, accounting, and
other costs of maintaining a registered investment company, which costs
currently exceed the amount of revenues generated by the fees under the
Contracts.
    7. Applicants submit that the relief is consistent with the
protection of investors and the purposes fairly intended by the policy
and provisions of the 1940 Act.

III. Conditions

    Applicants consent to the following conditions to any Order issued
by the Commission:
    1. The Company will continue to be responsible for satisfying all
the obligations to Contract owners as specified under the terms of
their Contracts. In addition, promptly after the issuance of the Notice
of the application, the Company will deliver a written document to all
Contract owners that will state that the Notice has been issued; that,
consequently, after the order granting the relief requested in the
Notice is issued, certain legal protections afforded to Contract owners
allocating assets to an investment company registered under the Act no
longer apply to them; that, nevertheless, the terms and conditions of
such Contracts have not changed; and that the Company continues to be
responsible for satisfying all the obligations to such Contract owners
as specified under the terms of their Contracts. In the event a
Contract owner transfers money from the Fixed Account to the Separate
Account, the Company and the Separate Account will notify such
transferring Contract owner that the Separate Account is no longer a
Separate Account registered under the Act and provide the Contract
owner a one-time opportunity to transfer the money back into the Fixed
Account prior to the 12 month holding period required by the Contracts.
Any subsequent transfer by the same Contract owner from the Fixed
Account to the Separate Account will be subject to the 12 month holding
period required by the Contracts.
    2. The Company will continue to be responsible for maintaining
records of the values under each owner's Contract, providing quarterly
statements and transaction confirmations to Contract owners, and all
other administrative functions in connection with the Separate Account.
As in the past, the Company may retain one or more administrators to
provide such services, but the Company will remain ultimately
responsible therefor.
    3. The Separate Account will at all times continue to be operated
in the manner contemplated by Rule 0-1(e)(1) and (2) under the Act.
Specifically:
    (a) The Separate Account will continue to be an account established
and maintained by an insurance company pursuant to the laws of a state
or territory of the United States under which income, gains and losses,
whether or not realized, from assets allocated to the Separate Account
are, in accordance with the Contracts, credited to or charged against
the Separate Account without regard to other income, gains or losses of
the insurance company,
    (b) the Separate Account shall be legally segregated and the assets
of the Separate Account will, at the time during the year that
adjustments in the reserves are made, have a value at least equal to
the Company's reserves and other contract liabilities with respect to
the Separate Account, and, at all other times, will have a value
approximately equal to or in excess of such reserves and liabilities,
and
    (c) that portion of the Separate Account's assets having a value
equal to such reserves and contract liabilities will not be chargeable
with liabilities arising out of any other business that the Company may
conduct.
    4. The Company and the Separate Account will operate in compliance
with applicable state insurance law, including but not limited to
filing annual audited financial statements of the Company and the
Separate Account with the insurance department of the Company's
domiciliary state.
    5. The Company will provide Contract owners invested in the
Separate Account with copies of the annual audited financial statements
of the Company and the Separate Account.
    6. The Company and the Separate Account will not solicit additional
contributions from Contract owners, or resume the sale of Contracts,
and will not use the Separate Account to issue any other annuity
contracts that would require the Separate Account to be registered
under the Act unless so registered. In addition, the Company and the
Separate Account will not solicit transfers from the Fixed Account into
the Separate Account. Furthermore, the Separate Account will not be
used for any other business other than as a funding vehicle for the
Contracts.
    7. The Separate Account will re-register under the Act should the
number of beneficial owners invested in the Separate Account exceed
100.
    8. The Separate Account will continue to create, maintain and keep
current the books and records as set forth in Rules 31a-1 and 31a-2
under the Act for the periods specified by these Rules.

IV. Conclusion

    For the reasons and upon the facts set forth above and in the
application, Applicants submit that their exemptive request meets the
standards set out in Section 6(c) of the Act and that the Commission,
therefore, should grant the requested Order.

    For the Commission, by the Division of Investment Management,
pursuant to delegated authority.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-02181 Filed 2-1-17; 8:45 am]
BILLING CODE 8011-01-P