	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

	[EPA-R03-OAR-2008-0472; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Virginia;

Stafford County Reasonably Available Control Technology Under the 8-Hour
Ozone National Ambient Air Quality Standard

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

SUMMARY:  EPA is approving a State Implementation Plan (SIP) revision
submitted by the

Commonwealth of Virginia.  This SIP revision fulfills Virginia’s
reasonably available control technology (RACT) requirements under the
Clean Air Act (CAA or the Act) with respect to the 8-hour ozone national
ambient air quality standard (NAAQS) in Stafford County.  Virginia has
fulfilled these requirements by submitting a certification that 1-hour
ozone NAAQS RACT controls for sources in the Commonwealth subject to
control technology guidelines (CTGs) and for a single major source not
subject to any CTG, continue to represent RACT under the 8-hour NAAQS,
and submitting a negative declaration demonstrating that no facilities
exist in Stafford County that are subject to certain enumerated CTGs
that have not been adopted by Virginia.

EFFECTIVE DATE:  This final rule is effective on [insert date 30 days
from date of

publication].

ADDRESSES:  EPA has established a docket for this action under Docket
ID Number EPA-R03-OAR-2008-0472.  All documents in the docket are listed
in the www.regulations.gov

website. Although listed in the electronic docket, some information is
not publicly available, i.e., confidential business information (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 electronically through www.regulations.gov or in hard
copy for public inspection during normal business hours at the Air
Protection Division, U.S. Environmental Protection

Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.
Copies of the State submittal are available at the Virginia Department
of Environmental Quality, 629 East Main Street, Richmond, Virginia,
23219.

FOR FURTHER INFORMATION CONTACT:  Gregory Becoat,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I.  Background

On August 7, 2008 (73 FR 45925), EPA published a notice of proposed
rulemaking (NPR) for the Commonwealth of Virginia.  The NPR proposed
approval of Stafford County’s requirements of RACT under the 8-hour
ozone NAAQS set forth by the CAA.  The formal SIP revision was submitted
by the Virginia Department of Environmental Quality on April 21, 2008.

II.  Summary

Sections 172(c)(1) and 182(b)(2) of the CAA require that all SIPs
satisfy the nitrogen oxides (NOx) and volatile organic compounds (VOCs)
RACT requirements that apply in areas that have not attained the NAAQS
for ozone.  See 42 U.S.C. 7502(c)(1), 42 U.S.C. 7511a(b)(2), and 42
U.S.C. 7511a(f).  EPA has determined that States that have RACT
provisions approved in their SIPs for 1-hour ozone nonattainment areas
have several options for fulfilling the RACT requirements for the 8-hour
ozone NAAQS.  If a State meets certain conditions, it may certify that
previously adopted 1-hour ozone RACT controls in the SIP continue to
represent RACT control levels for purposes of fulfilling 8-hour ozone
RACT requirements.  See Final Rule To Implement the 8-Hour Ozone
National Ambient Air Quality Standard--Phase 2; Final Rule To Implement
Certain Aspects of the 1990 Amendments Relating to New Source Review and
Prevention of Significant Deterioration as They Apply in Carbon
Monoxide, Particulate Matter and Ozone NAAQS; Final Rule for
Reformulated Gasoline (Phase 2 Rule) 70 FR 71612, 71655, November 29,
2005.  Alternatively, a State may adopt new or more stringent
regulations that represent RACT control levels, either in lieu of or in
conjunction with a certification.

The Commonwealth of Virginia has submitted a certification that
previously adopted RACT controls in Virginia’s SIP that were approved
by EPA under the 1-hour ozone NAAQS continue to represent RACT for the
8-hour implementation purposes.  This previously adopted RACT consists
of Virginia’s adoption of EPA promulgated CTGs for those source
categories that apply to existing sources in Stafford County.  Virginia
has also submitted a negative declaration demonstrating that no
facilities exist in Stafford County for those CTGs that have not been
adopted by Virginia.

Virginia has also certified, based on consideration of additional
research, that the 1-hour ozone NAAQS RACT determination for the only
major stationary source located in Stafford County not covered by a CTG
continues to represent RACT under the 8-hour ozone NAAQS.  Other
specific requirements of RACT and the rationale for EPA's proposed
action are explained in the NPR and will not be restated here.

On September 8, 2008, EPA received adverse comments from State of New
Jersey Department of Environmental Protection on the NPR.  A summary of
the comments submitted and EPA(s response is provided in Section III of
this document.

III.  Summary of Public Comments and EPA Responses

Comment:  The commenter opposes the approval of the SIP revision
submitted by Virginia for Stafford County.  The commenter notes that
Stafford County is a moderate ozone nonattainment area, and is required
to implement RACT on all major VOC and NOx sources, and all sources
covered by a CTG.  The commenter also states that in the final rule to
implement the 8-hour ozone standard (i.e., the Phase 2 Rule) EPA
indicates that States may rely on existing CTGs and the prior 1-hour
RACT determinations as presumptive RACT.  The comment also states that
most CTGs and prior 1-hour RACT determinations were done over a decade
ago, and asserts that the emission limits are no longer RACT because of
advancements in air pollution control technology.  This is especially
the case, it argues, for nitrogen oxides.  Additionally, the commenter
appears to believe that section 108 of the Act requires EPA to review,
modify and reissue control technology in a timely fashion, that EPA has
failed to do so, and that this failure to do so prevents EPA from
allowing States the discretion of certifying that previous 1-hour ozone
RACT determinations fulfill obligations under the 8-hour ozone NAAQS.
The commenter also asserts that it is adversely affected because it is a
downwind state.  Finally, the commenter notes that and sections
110(a)(2)(D) and Part D of the CAA require upwind states to include
adequate controls in their SIPs prohibiting interstate transport of air
pollutants in amounts that contribute to nonattainment in any downwind
state.

Response:  The commenter correctly notes that Stafford County is a
moderate ozone nonattainment area and is required to implement RACT on
all major VOC and NOx sources, and all sources covered by a CTG.  The
RACT provisions of the CAA are set forth in sections 172(c)(1) and
182(b)(2) of Part D of the Act.  42 U.S.C. 7502(c)(1), 42 U.S.C.
7511a(b)(2).  Section 172 applies to RACT in so-called “subpart 1”
areas.  Stafford County is not a “subpart 1” area.  RACT, as it
applies in moderate or above ozone nonattainment areas, or within the
OTR, i.e., to Stafford County, is a specific requirement set forth in
Section 182(b)(2) of Part D of the Act.  Section 182(b)(2) identifies
the categories of sources to which RACT applies.  Section 182(b)(2) does
not specify the level of control required to meet the RACT requirement.

The commenter also correctly acknowledges that the Phase 2 Rule, 70 FR
71612, explicitly addressed whether, and the circumstances under which,
states may continue to rely on existing CTGs and the prior 1-hour RACT
determinations.  Specifically, in the Phase 2 Rule, EPA determined that
States may certify that “previously required RACT controls represent
RACT for 8-hour implementation purposes.” 70 FR at 71652.

The commenter does not allege that EPA’s approval of the SIP revision
is inconsistent with the provisions of the Phase 2 Rule.  The final
action establishing those provisions was taken by EPA, not in today’s
action, but in the Federal Register notice for the Phase 2 Rule
published on November 29, 2005, 70 FR 71612.   Challenges to the Phase 2
Rule have been brought by commenter and others in the U.S. Court of
Appeals for the District of Columbia.  Natural Resources Defense Council
v EPA (D.C. Cir. No. 06-1045 and consolidated cases).

The Phase 2 Rule, in fact, explicitly addresses the State’s obligation
to consider new information when deciding whether to certify that prior
RACT determinations remain valid for the 8-hour ozone NAAQS.  The
commenter does not allege that the State has failed to satisfy that
obligation, or that it has not met any other requirements in the Phase 2
Rule for certifying that its prior RACT determinations remain valid for
the 8-hour ozone NAAQS.  Thus, while we agree with commenter that many
of the CTGs have not been revised since they were issued, we do not
agree that it is therefore improper for EPA to approve this SIP
revision.  In the Phase 2 Rule, EPA specifically addressed concerns
arising from our recognition that “the CTGs/ACTs . . . may not provide
the most accurate picture of current control options.”  70 FR at
71655.

In response, we decided that “States and other interested parties
should consider available information that may supplement the CTG and
ACT documents.  In cases where additional information is presented, for
example, as part of notice-and-comment rulemaking on a RACT SIP
submittal, States (and EPA) would necessarily consider the additional
data in reviewing what control obligation is consistent with RACT.”
70 FR at 71655.  Only after conducting this review may a State certify
that a 1-hour ozone RACT determination continues to represent an
appropriate RACT level of control for the 8-hour ozone program.  Id.
Absent data indicating that the previous RACT determination is no longer
appropriate, the State may certify that the existing 1-hour RACT
determination fulfills the requirement for 8-hour ozone RACT, and the
State need not submit in its SIP a new RACT requirement for those
sources. Id.

Although the commenter broadly alleges that the CTGs no longer reflect
RACT because they have not been updated recently, the commenter does not
identify any specific deficiencies or indicate which, if any, of the
particular CTGs adopted by Virginia it believes to be defective.
Furthermore, no evidence in the record indicates that Virginia either
determined -- or that anyone brought to its’ attention during the
notice and comment rulemaking for this SIP submission – that evidence
existed to cast doubt on the appropriateness under the 8-hour ozone
NAAQS of any of the previously adopted and SIP-approved CTGs.  A
commenter bears some burden of bringing to an agency’s attention at
least some particulars of an alleged defect in a rulemaking.  See,
International Fabricare Inst. v. EPA, 972 F.2d 384, 391 (D.C. Cir.
1992).

In sum, the commenter has not identified any new information that has
become available, but that the State did not consider and has not even
alleged that any particular CTG actually adopted into the Virginia SIP
fails to represent RACT under the 8-hour ozone NAAQS.  Thus, under the
specific terms of the Phase 2 ozone implementation rule, Virginia is
entitled to rely on that Rule’s presumption that absent evidence to
the contrary, a state may certify that CTGs previously adopted to meet
1-hour ozone NAAQS continue to meet the requirements for RACT under the
8-hour ozone NAAQS. See 70 FR at 71652, 71654-55.

With respect to the single major source in Stafford County that is not
subject to a CTG, Virginia took reasonable steps to seek out additional
information to assure that the 1-hour ozone NAAQS source-specific RACT
determination for this source continues to represent RACT under the
8-hour ozone NAAQs.  This is consistent with our determination in the
Phase 2 Rule that the certification must be submitted with appropriate
supporting information, including the consideration of new data.  In all
cases where additional information is presented, States (and EPA) must
consider the additional information as part of that rulemaking, and
absent such information, the State may certify existing RACT as meeting
the 8-hour ozone requirements. 70 FR at 71655.

Virginia reviewed EPA’s RACT/BACT/LAER clearinghouse for sources
within the same Standard Industrial Classification code as the sole
major non-CTG source in Stafford County, and determined that there was
no information to indicate that the 8-hour ozone RACT determination
should be different from the August 10, 1998 1-hour ozone RACT
determination for this facility, which has been approved by EPA.  See 66
FR 8, January 2, 2001.  Based on the forgoing, the low potential
emissions from the facility, and the even lower actual emissions from
the facility, Virginia determined in its SIP submission, consistent with
the Phase 2 Rule, that the existing 1-hour RACT determination could be
certified as fulfilling the 8-hour ozone RACT requirements.  As with our
analysis with respect to the CTG RACT certification, we believe that
Virginia is entitled to rely on the Phase 2 Rule’s presumption that
absent evidence to the contrary, a state may certify this 1-hour ozone
NAAQS determination as meeting the requirements for RACT under the
8-hour ozone NAAQS.

We also do not agree with commenter’s apparent beliefs regarding
section 108 of the Clean Air Act.  With respect to that section, the
commenter states that “[a]ccording to Section 108(c) of the Clean Air
Act, EPA has an obligation to review, modify and reissue control
techniques” and that “USEPA has failed to do so in a timely
fashion.”  Section 108 of the Act provides that “the Administrator
shall from time to time review, and as appropriate, modify or reissue
any criteria or information on control techniques. . .”  Section 108
does not establish time frames for the Administrator to review, modify,
or reissue control techniques.  Furthermore, section 108 provides that
the review, modification or reissuance of a RACT is only to be done
“as appropriate.” EPA believes that Congress left the decision
whether to review, modify or reissue a control technique to the
Administrator’s discretion.

Finally, with respect to the comments related to requirements of section
110(a)(2)(D) and Part D of the Act, EPA agrees with the commenter that
section 110(a)(2)(D) requires, among other things, that a State’s SIP
needs to contain provisions to regulate the interstate transport of air
pollution that significantly contributes to nonattainment or interferes
with maintenance of a NAAQS in another State. 42 U.S.C. 7411(a)(2)(D).
Although Title I, Part D of the Act does not contain similar language,
section 184 is within Title I, Part D of the Act.  Section 184 contains
specific provisions to address interstate transport of ozone and its
precursors within the Ozone Transport Region (OTR) (which includes both
New Jersey and Stafford County).  This comment, however, is not relevant
to the present action because EPA is not taking action here to determine
whether Virginia has satisfied the requirements of CAA sections
110(a)(2)(D) or 184.  EPA has never interpreted the RACT provisions in
section 172(c)(1) or 182(b)(2) as requiring States to address interstate
transport issues.  Indeed, EPA has expressly stated in the Phase 2 Rule
that we “believe [] that section 172(c) is not the appropriate section
of the CAA to address the transport of ozone and ozone precursors. .
.” 70 FR at 71653.  We believe, based on the forgoing, that the
section 182(b)(2) RACT requirements also are not intended as a mechanism
for addressing interstate transport of pollutants.

IV.  General Information Pertaining to SIP Submittals from the
Commonwealth of Virginia

In 1995, Virginia adopted legislation that provides, subject to certain
conditions, for an environmental assessment (audit) (privilege(' for
voluntary compliance evaluations performed by a regulated entity.  The
legislation further addresses the relative burden of proof for parties
either asserting the privilege or seeking disclosure of documents for
which the privilege is claimed.  Virginia's legislation also provides,
subject to certain conditions, for a penalty waiver for violations of
environmental laws when a regulated entity discovers such violations
pursuant to a voluntary compliance evaluation and voluntarily discloses
such violations to the Commonwealth and takes prompt and appropriate
measures to remedy the violations.  Virginia's Voluntary Environmental
Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege
that protects from disclosure documents and information about the
content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to documents
or information (1) that are generated or developed before the
commencement of a voluntary environmental assessment; (2) that are
prepared independently of the assessment process; (3) that demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney
General provided a legal opinion that states that the Privilege law, Va.
Code Sec. 10.1-1198,  precludes granting a privilege to documents and
information (required by law,( including documents and information
(required by Federal law to maintain program delegation, authorization
or approval,( since Virginia must (enforce Federally authorized
environmental programs in a manner that is no less stringent than their
Federal counterparts. . . .(   The opinion concludes that ([r]egarding (
10.1-1198, therefore, documents or other information needed for civil or
criminal enforcement under one of these programs could not be privileged
because such documents and information are essential to pursuing
enforcement in a manner required by Federal law to maintain program
delegation, authorization or approval.(

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that ([t]o
the extent consistent with requirements imposed by Federal law,(  any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or civil
penalty.  The Attorney General's January 12, 1998 opinion states that
the quoted language renders this statute inapplicable to enforcement of
any Federally authorized programs, since (no immunity could be afforded
from administrative, civil, or criminal penalties because granting such
immunity would not be consistent with Federal law, which is one of the
criteria for immunity.(

Therefore, EPA has determined that Virginia's Privilege and Immunity
statutes will not preclude the Commonwealth from enforcing its program
consistent with the Federal requirements.  In any event, because EPA has
also determined that a state audit privilege and immunity law can affect
only state enforcement and cannot have any impact on Federal enforcement
authorities, EPA may at any time invoke its authority under the CAA,
including, for example, sections 113, 167, 205, 211 or 213, to enforce
the requirements or prohibitions of the state plan, independently of any
state enforcement effort.  In addition, citizen enforcement under
section 304 of the CAA is likewise unaffected by this, or any, state
audit privilege or immunity law.

IV.  Final Action

EPA is approving the SIP revision submitted to EPA by the Commonwealth
of Virginia on April 21, 2008.  This SIP revision contains the
requirements of RACT set forth by the CAA under the 8-hour ozone NAAQS.

V.  Statutory and Executive Order Reviews

A.  General Requirements

Under the CAA, the Administrator is required to approve a SIP
submission that complies with

the provisions of the Act and applicable Federal regulations.  42 U.S.C.
7410(k); 40 CFR

52.02(a).  Thus, in reviewing SIP submissions, EPA’s role is to
approve state choices, provided

that they meet the criteria of the CAA.  Accordingly, this action merely
approves state law as meeting Federal requirements and does not impose
additional requirements beyond those

imposed by state law.  For that reason, this action:

is not a "significant regulatory action” subject to review by the
Office of Management and Budget under Executive Order 12866 (58 FR
51735, October 4, 1993);

does not impose an information collection burden under the provisions of
the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

is certified as not having a significant economic impact on a
substantial number of small entities under the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.);

does not contain any unfunded mandate or significantly or uniquely
affect small governments, as described in the Unfunded Mandates Reform
Act of 1995 (Public Law 104-4);

does not have Federalism implications as specified in Executive Order
13132 (64 FR

	43255, August 10, 1999);

is not an economically significant regulatory action based on health or
safety risks subject

	to Executive Order 13045 (62 FR 19885, April 23, 1997);

is not a significant regulatory action subject to Executive Order 13211
(66 FR 28355,

	May 22, 2001);

is not subject to requirements of Section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)
because application of those

	requirements would be inconsistent with the CAA; and

does not provide EPA with the discretionary authority to address, as
appropriate, disproportionate human health or environmental effects,
using practicable and legally permissible methods, under Executive Order
12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have tribal implications as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP
is not approved to apply in Indian country

located in the state, and EPA notes that it will not impose substantial
direct costs on tribal governments or preempt tribal law.

B.   Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the

agency promulgating the rule must submit a rule report, which includes a
copy of the rule, to

each House of the Congress and to the Comptroller General of the United
States.  EPA will

submit a report containing this action and other required information to
the U.S. Senate, the U.S. House of Representatives, and the Comptroller
General of the United States prior to publication

of the rule in the Federal Register.  A major rule cannot take effect
until 60 days after it is

published in the Federal Register.  This action is not a “major
rule” as defined by 5 U.S.C.

804(2).

C.  Petitions for Judicial Review

Under section 307(b)(1) of the Clean Air Act, petitions for judicial
review of this action must be filed in the United States Court of
Appeals for the appropriate circuit by [Insert date 60 days from date of
publication of this document in the Federal Register].  Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action.

This action, pertaining to the Stafford County RACT under the 8-hour
ozone NAAQS, may not be challenged later in proceedings to enforce its
requirements.  (See section 307(b)(2).)

List of Subjects in 40 CFR part 52

Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping
requirements, Volatile organic compounds.

__December 11, 2008_____
____________/s/______________

Dated:                            				 Donald S. Welsh,
               						                         Regional Administrator,

            Region III.

40 CFR Part 52 is amended as follows:

PART 52 - [AMENDED]

1.  The authority citation for 40 CFR part 52 continues to read as
follows:

               Authority:  42 U.S.C. 7401 et seq.

Subpart VV ( Virginia

2.  In Section 52.2420, the table in paragraph (e) is amended by adding
the entry for RACT under the 8-hour ozone NAAQS-Stafford County at the
end of the table to read as follows:

( 52.2420  		Identification of plan.

*		*		*		*		*

(e)* * *

Name of non-regulatory SIP revision

Applicable geographic area

State submittal date

EPA approval date

Additional

explanation

*                    *                      *                   *
           *                 *                    *

RACT under the

8-Hour NAAQS

Stafford County

4/21/2008

[Insert Federal Register page number where the document begins and date]

 PAGE

 PAGE  4


Docket ID No. EPA-HQ-OPPT-2013-0171

Response to Public Comments on the
Public Review Draft of the
Information Collection Request (ICR) entitled:
"Tier 2 Testing of Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)"
                         (78 FR 37803, June 24, 2013)
                                 June 25, 2015
Table of Contents
I.	Introduction	1
II.	Commenters	2
III.	Comments and Responses	3
A.	Evaluate whether the proposed collection of information is necessary for the
proper performance of the functions of the Agency including practical utility.	3
B.	Evaluate the accuracy of the Agency's estimates of the burden	4
C.	Enhance the quality, utility, and clarity of the information to be collected.	5
D.	Minimize the burden of the collection of information	5
E.	Time Alloted for the for the Reproduction and Fertility Effects test
(OCSPP Guideline 870.3800)..	6
F.	Additional Comments	6

Introduction

EPA's Endocrine Disruptor Screening Program (EDSP) was established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which required EPA to develop a chemical screening program using validated test methods and other scientifically relevant information (OSRI) to determine whether certain substances may have estrogenic effects in humans. The EDSP consists of a two-tiered approach to screen chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening is to identify substances that have potential bioactivity with the estrogen, androgen, or thyroid hormonal systems using a battery of assays. Based on a Weight of Evidence (WoE) analysis, substances that have potential bioactivity with estrogen, androgen or thyroid systems will be considered for Tier 2 testing. Tier 2 tests are designed to establish dose-response relationships for any potential adverse effect to be used in risk assessment. Additional information about the EDSP is available through the Agency's Web site at http://www.epa.gov/endo.

This "Response to Public Comments" document specifically addresses public comments EPA received on a draft information collection request (ICR) (EPA ICR No. 2479.01) under the Paperwork Reduction Act (PRA), 44 USC 3501 et seq., covering the information collection activities associated with Tier 2 testing of chemicals under EPA's EDSP. The ICR addresses the information collection activities for those List 1 chemicals that were screened under Tier 1 and are now proceeding to testing under Tier 2. The ICR covers the full range of information collection activities associated with Tier 2 of the EDSP, including the paperwork activities associated with the issuance of Tier 2 orders, initial responses from order recipients, paperwork activities associated with generating the data requested, and submitting the data to EPA pursuant to the order.

This "Response to Public Comments" document provides a summary of the comments specifically received on, and related to, to the ICR, and the Agency's responses to those comments.
Commenters

The following table identified the five sets of comments filed. Note that number 5 (EPA-HQ-OPPT-2013-0171-0007) included three signatures representing three separate affiliations.

                                    #[(1)]
                                   DCN[(2)]
                              Commenter Name[(3)]
                                  Affiliation
                                   Code[(4)]
                                       1
EPA-HQ-OPPT-2013-0171-0003
Clare Thorp
Senior Director, Human Health Policy, CLA
Administrator, EPF
Endocrine Policy Forum
                                      EPF
                                       2
EPA-HQ-OPPT-2013-0171-0004
S. Slaughter
The Center for Regulatory Effectiveness
                                      CRE
                                       3
EPA-HQ-OPPT-2013-0171-0005
Emily V. Tipaldo
Manager, Regulatory and Technical Affairs
American Chemistry Council
                                      ACC
                                       4
EPA-HQ-OPPT-2013-0171-0006
Not stated
Council of Producers & Distributors of Agrotechnology
                                     CPDA
                                       5
EPA-HQ-OPPT-2013-0171-0007
Patricia L. Bishop
Research Associate, Regulatory Testing Division
People for the Ethical Treatment of Animals
                                 PETA (et al.)

Kristie Sullivan, MPH
Director, Regulatory Testing Issues
Physicians Committee for Responsible Medicine

Catherine Willett, PhD
Director, Regulatory Toxicology, Risk Assessment and Alternatives
Animal Research Issues
The Humane Society of the United States

Key:
(1) This is the number that is used in this document to refer to this particular commenter/set of comments.
(2) This is the number that is used to identify this comment in the docket at www.regulations.gov
(3) This is the name of the individual that submitted the comments, along with their affiliation, if provided.
(4) This is the code used in this document to identify commenters.

Comments and Responses
This document summarizes the comments received and the Agency's response -- grouping similar topics together.  The first five groups reflect the five specific areas the Agency explicitly requested comment on in its federal register notice, as follows:
A. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.
B. Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
C. Enhance the quality, utility, and clarity of the information to be collected.
D. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.  In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.
E. EPA is specifically requesting comments on the duration of the time allotted for the Reproduction and Fertility Effects test (OCSPP Guideline 870.3800).  The Agency is considering a range from 24 to 48 months, but for the purpose of the ICR calculations, it is assumed that all work will be completed within the 3-year duration of the ICR.

Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility.

Commenter CRE: Asserts that EPA has not demonstrated that the Tier 2 tests have practical utility or that they meet Information Quality Act (IQA) guidelines.

Agency Response: EPA disagrees that the practical utility of the information obtained from the Tier 2 tests has not been demonstrated and that the tests do not meet Information Quality Act (IQA) guidelines.

The purpose of EDSP Tier 1 data are to determine if a chemical has potential endocrine bioactivity.  EDSP Tier 1 data are mechanistic in nature.  Endocrine bioactivity potential is identified for a chemical after the EDSP Tier 1 battery has been conducted and an EDSP Tier 1 WoE determination has been completed.  The EDSP Tier 1 WoE also identifies if any EDSP Tier 2 testing will be required.  The purpose of EDSP Tier 2 testing is to identify whether there is an interaction with the endocrine system and establish a quantitative, dose-response relationship for any adverse effects that might result from that interaction.  EDSP Tier 2 dose-response data will be critical to identifying the hazard associated with the chemical when conducting a risk assessment.  The practical utility of EDSP Tier 2 data are to provide this dose-response information for risk assessment purposes.  EDSP Tier 2 data will provide a hazard endpoint for potential regulation of the chemical.  Again, this is the practical utility of EDSP Tier 2 data and has been outlined in the EDSP Tier 2 ICR supporting statement.

EPA has extensive experience in using data from multiple sources to develop integrated assessments of hazard, modes of action/mechanisms of toxicity, and overall potential for risk. EPA scientists will continue to use such experience, together with data from EDSP Tier 2 tests, to address the potential of chemicals to cause adverse effects as a consequence of interaction with the endocrine system.  In fact, EPA has considered the potential interaction of a chemical with the endocrine system in making certain pesticide registration decisions.  For example, EPA considered endocrine-mediated effects in preparing the risk assessments of procymidone and vinclozolin.

The Agency is confident that it has reasonably projected and minimized paperwork burden and cost, and demonstrated practical utility of the data requested.

Commenters EPF:  Asserts that practical utility cannot be definitively judged until the Agency responds to, and implements the recommendations from two Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panels (SAP):

   1)	June 25-28, 2013, EDSP Tier 2 Ecotoxicity Tests
   2)	July 30-August 2, 2013, Weight-of-Evidence (WoE): Evaluating Results of EDSP Tier 1 Screening

According to EPF, the Tier 2 Ecotox Tests SAP report is expected to:

   "provide the SAP's opinion on the reproducibility of results and factors that may impact interpretation of whether or not the proposed Tier 2 tests are adequate to provide a more comprehensive assessment of the potential of a test chemical to cause endocrine-mediated adverse effects in the subject taxa."

The WoE SAP report:

   "is expected to provide recommendations to EPA that will help them determine how many compounds proceed to Tier 2 and which studies are needed

EPF specifically questioned:

   "If the [WoE] SAP recommendations are adopted, how will these costs be captured in a transparent fashion?  Will a specific Policies and Procedures section be added at a later date to a revised WoE document?"

Agency Response: EPA has reviewed the panel reports to which the commenter is refering to.  EPA has implemented the pertinent changes to the Tier 2 test methods suggested by the SAP.

The Agency received the FIFRA SAP's final report on the Tier 2 test methods in September 2013.  The report was generally supportive of EPA's Tier 2 tests and stated "the Panel supports the scientific rationale and purpose, representative species chosen, biological and toxicological relevance of the major endpoints selected and measured, and the validation process used by EPA for all four proposed Tier 2 ecotoxicity tests."  The FIFRA SAP did recommend some improvements to the Tier 2 tests, which the Agency considered and implemented.  However, EPA notes that the particular changes recommended by the FIFRA SAP pertained neither to the overall practical utility of the Tier 2 tests nor to the burdens and costs associated with these tests.

The Agency received the SAP's final report on the WoE methods in October 2013.  The report was generally supportive of EPA's approach to making EDSP Tier 1 WoE decisions.  The particular Tier 2 studies being requested (for chemicals identified as having potential endocrine bioactivity in the Tier 1 program) were not discussed at this FIFRA SAP meeting.  Discussion of these studies was not, therefore, a component of the meeting report.

Commenters ACC & PETA (et al.):  Assert that practical utility cannot be definitively judged until the Agency responds to, and implements the recommendations from two Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory Panels (SAP):

Agency Response: EPA disagrees with that the practical utility of the information obtained from EDSP Tier 2 testing cannot be determined until after the recommendations of the FIFRA SAP are responded to/implemented.  Furthermore, this concern has been "overcome by events," namely, the FIFRA SAP reports for these meetings have been issued and reviewed by EPA.

Commenter CPDA: Asserts that because the Agency has not demonstrated the practical utility of the Tier 1, List 1 screening ICR in accordance with OMB's Terms of Clearance; the Agency cannot demonstrate the practical utility of this Tier 2, List 1 testing ICR.

Agency Response: The Agency asserts: 1) that practical utility of the Tier 1, List 1 screening ICR has been established, 2) that EPA satisfied the Tier 1, List 1 Terms of Clearance, and 3) that the status of the Tier 1, List 1 ICR is a separate issue from the status of this Tier 2, List 1 testing ICR.

The May 21-23, 2013, EDSP Tier 1 Screening Assays and Battery Performance FIFRA SAP external peer review panel reconfirmed the practical utility of the Tier 1 battery to determine whether a chemical has potential endocrine bioactivity.  The performance of each assay and the Tier 1 battery were judged to have performed as anticipated (Tier 1 Assay SAP Final Report).

With respect to the terms of clearance related to OMB's approval of the Tier1, List 1 ICR, OMB's renewal of the ICR on July 31, 2013 is evidence that EPA satisfied the Terms of Clerance..  The Agency notes that the language the commenter refers to as the OMB Terms of Clearance was significantly revised by OMB for the renewal in 2013. EPA remains engaged in the process of fulfilling the conditions outlined in this revision.

Commenter PETA (et al.): Recommends that the Agency consider OSRI submissions in Tier 2 testing.
Commenter CPDA:  For EDSP List 1 Tier 1, EPA rejected an excessive proportion of EDSP OSRI, and without transparent review.

Agency Response: The Agency agrees with PETA's suggestion that EPA should consider OSRI submissions in Tier 2 testing.  The Agency will continue to consider OSRI submissions, including OSRI submissions in Tier 2 testing.  Furthermore, EPA has now included OSRI submissions in EDSP ICR calculations (which were not included in early ICRs related to the EDSP).

EPA disagrees, however, with CPDA comments related to the acceptance rate for OSRI.  In more than half of all the instances where OSRI was submitted for a chemical (27 of 47 or ~57.4%), EPA determined that the requirement for one or more EDSP Tier 1 study had been met because the OSRI submitted was determined to be sufficient.  All EDSP List 1 Tier 1 OSRI submissions and EPA's review of the submissions can be accessed at http://www.epa.gov/endo/pubs/EDSP_OSRI_Response_Table.pdf.  As for the transparency of OSRI reviews, again the table just cited provides ample support.  For every List 1 chemical that cited OSRI, the table provides a link to chemical specific docket at www.regulations.gov to both the rationale (supplied by the order recipient) and EPA's detailed review of this OSRI.
Also, an EDSP WOE Guidance document has been revised based on the public comments received and an amended document has been placed in the docket at www.regulations.gov under Docket ID No. EPA HQ OPPT 2010 0877.

Evaluate the accuracy of the Agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
Commenters EPF and ACC: Assert that the Agency cannot accurately estimate burden and costs until after the exact number of chemicals that will proceed to Tier 2 testing is known; and the Agency implements recommendations from both the Tier 2 Ecotox Tests and the WoE SAPs.  The commenters challenge the Agency's estimates of the number of List 1 chemicals that will proceed to Tier 2 testing (26), the estimated number of respondents (210), and both the industry and agency burdens associated with Tier 2 testing and data evaluation.

Agency Response:  The Agency agrees that the exact number of chemicals that will proceed to the EDSP Tier 2 are not known.  However, the Agency disagrees that the ICR cannot move forward until the exact number of chemicals that will proceed to Tier 2 testing is known.  EPA had previously estimated 210 respondents as a reasonable upper bound estimates in spite of the uncertainties.  For purposes of the ICR and the requirements of the Paperwork Reduction Act, it is more important that the burden is not underestimated than that it be exact.  The nature of the particular uncertainties surrounding the respondent estimate as described in the ICR supporting statement would tend to indicate that 210 is an overestimate.  The Agency was clear in the Tier 2 ICR supporting statement that 210 respondents is an overestimation.

As time has passed since the draft ICR went out for public comment, the Agency now believes that the estimate of 210 respondents can be reduced (for the purpose of ICR burdens and costs calculations) to 100 respondents.  100 respondents is still an upper-bound estimate that should not underestimate the number of respondents. When a clearer, more accurate estimation of the number of respondents is available, EPA will submit a revision to OMB.  The Agency continues to support its upper-bound estimate that no more than 26 chemicals from List 1 will proceed to Tier 2 testing.

See Agency Response in section A (above) for the Agency's position on the timing of the Tier 2 ICR as it relates to the FIFRA SAPs.

Commenters ACC and CPDA:  Assert that the Agency underestimates the industry cost associated with complying with the ICR.
Commenter ACC:  Requests that the Agency submit the final Tier 2 test guidelines to a representative number of qualified laboratories and requests detailed cost estimates, including costs for the analytical chemistry requirements to establish a solid basis for the cost calculation in the ICR.

Agency Response:  EPA disagrees with these comments.  The Agency is confident that the projections in the ICR are reasonable upper-bound estimations of the costs associated with the issuance of (and compliance with) EDSP Tier 2 orders.  As above, no factual evidence was submitted by the commenters that the industry costs are likely to be underestimates.  Furthermore, Tier 2 tests are similar to multi-generation studies currently required by EPA's Office of Pesticide Programs (OPP).  These studies are an established basis from which EPA reasonably extrapolated the estimated costs of the EDSP Tier 2 tests.  In particular, one of the four Tier 2 tests (Mammalian 2-Generation Rat) has been required for decades by OPP and those costs are especially well-known.

Enhance the quality, utility, and clarity of the information to be collected.
Commenters EPF, CRE, ACC, CPDA & PETA (et al.):  Assert that the agency cannot maximize the quality, utility and clarity of the information collection until the agency implements recommendations from 1) the Tier 2 Ecotox Tests SAP, 2) the WoE SAP, and 3) the May 21-23, 2013, Tier 1 Assay SAP.  Commenters assert that this ICR should not have been issued for comment until the final test guidelines and protocols were publically available.

Agency Response: See Agency Response in section A (above) for the agency's position on the timing of the Tier 2 ICR as it relates to the FIFRA SAPs.

Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.  In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.
Commenter EPF: Supports the agency's use of automated electronic submission processes and recommends that the agency issue Data Entry Spreadsheet Templates (DESTs) and Standard Evaluation Procedures (SEPs) before any tests commence to promote efficiency. Further, the commenter recommends increasing the amount of time alloted between the initial test order response (order date plus 90 days, plus 10 days) and the final submission of data (order date plus 24 to 48 months).  Furthermore EPA asserts that this will allow for discussion and resolution of questions and uncertainties, and minimize industry burden associated with processing extension requests.

Agency Response:  The Agency is planning on having the SEPs and DESTs, available in advance of issuance of Tier 2 orders.  These documents serve several purposes including clarifying some specific expectations of the guideline requirements.  Also, if the respondent knows they intend to generate the data, they are neither obligated to wait the 90 plus days to submit their response, nor to commence the study.  If the order recipients are concerned about the conduct of a study in the timeframe provided, a protocol can be submitted with your response "to generate the data" for agency review to minimize questions and issues.  The Agency established the timeframes for the studies after considering the amount of time one might reasonably expect is needed to complete each test, including the planning activities before commencement of testing, actual performance of the test, analyzing test results, completing the final study report, and submission preparations to the Agency.

EPA is specifically requesting comments on the duration of the time allotted for the Reproduction and Fertility Effects Test (OCSPP Guideline 870.3800). The Agency is considering a range from 24 to 48 months, but for the purpose of the ICR calculations, it is assumed that all work will be completed within the 3-year duration of the ICR.
Commenter EPF: 48 months should be the minimum time allotted for registrants to complete and report the Reproduction and Fertility Effects test when required.

Agency Response:  To ensure consistency and allow ample time for conducting the mammalian reproduction and fertility effects test (OCSPP Guideline 870.3800), the Agency will allow respondents 48 months to complete this test.  While the Agency will allow 4 years to complete the Tier 2 tests, the ICR calculates the total estimated costs rather than annualized cost over 4 years.

Additional Comments
Commenter EPF: Regarding alternative responses to Tier 2 test orders...

   # Request an exemption under FFDCA section 408(p)(4).
      The commenter questions whether exemption under FFDCA section 408(p)(4) is really a viable option for Tier 2, presuming the Agency would only issue a Tier 2 test order for a given chemical if it believed that there was in fact potential for the chemical to interact with endocrine systems based on the results of Tier 1 screening and OSRI.

      Agency Response: The Agency agrees.  The basis for an exemption order under FFDCA section 408(p)(4) would be that the substance is not anticipated to produce in humans or any other organism an effect similar to that produced by a naturally occurring estrogen, androgen, or thyroid hormone.  EPA acknowledges that the very same evidence justifying the initial issuance of a Tier 2 test order would also tend to weigh against issuing an exemption order under FFDCA section 408(p)(4).

      As suggested by the commenter, EPA is revising the ICR supporting statement and accompanying Tier 2 order templates to remove the discussion about requesting an exemption order under FFDCA section 408(p)(4) as one of the response options for Tier 2 test order recipients.  The determination to issue an exemption order under FFDCA section 408(p)(4) is one that must be made by the Agency.  In the context of the ICR, there is no paperwork burden associated with the Agency's issuance of such an exemption order, which does not involve any respondent activities.

Pre-enforcement challenges to the test order.
      Commenter EPF asserts that the existing guidance on this option is unclear.

      Agency Response: The Agency disagrees.  EPA's conclusions about the availability of pre-enforcement review of the validity of test orders are discussed in detail in the 2009 Policies and Procedures document.  With respect to informal administrative review, EPA disagrees that it is unclear what sufficient detail means.  Sufficient detail means "sufficient specificity and detail to allow the Agency to adequately and fairly evaluate the issue(s) presented."  74 FR 17560, 17576 (April 15, 2009).  EPA acknowledges the Commenter EPF's statement that it is currently unclear about "what types of situations" would give a test order recipient cause to challenge the validity of any particular test order.  But EPA disagrees that the identified uncertainty (relating to the potential to litigate the validity of a test order) represents an impediment to estimating the burden of complying with the test orders.

Additional EDSP testing is unnecessary because the chemical is an endocrine disruptor or was used as a "positive control" in the EDSP Tier 2 validation effort.
      The commenter asserts that this option does not make sense in relationship to Tier 2 testing.

      Agency Response: The Agency concurs as long as the EDSP Tier 2 validation is suitable for the regulatory need.  This option will be deleted.

Commenter CRE:  Asserts that EPA is planning to abandon the EDSP Tier 1 screening and Tier 2 tests in favor of the CompTox.

Agency Response:  The Agency articulated its vision for in vitro replacement of in vivo studies in the EDSP21 Work Plan.  The Agency is considering the use in vitro studies as alternatives or replacement of the EDSP Tier 1 screens over time.  When decisions are made to use computational and high throughput methods in the EDSP, those decisions will be based on sound science with the goals of reducing testing cost, reducing the use of live animals, reducing paperwork burden and increasing efficiency in providing both human health and environmental protection.  EPA does not have an imminent plan to replace the EDSP Tier 2 tests with computational and high throughput alternative tests.


[Federal Register: January 3, 2006 (Volume 71, Number 1)]
[Notices]
[Page 103]
[DOCID:fr03ja06-59]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM05-4-000; RM05-4-001]

Interconnection for Wind Energy; Notice Extending Compliance Date

December 22, 2005.
    On December 12, 2005, the Commission issued its order on rehearing
and clarification in these proceedings. Interconnection for Wind
Energy, Order No. 661-A, 70 FR 75005 (Dec. 19, 2005), 113 FERC ] 61,254
(2005); see also Interconnection for Wind Energy, Order No. 661, 70 FR
34993 (June 16, 2005), FERC Stats. & Regs. ] 31,186 (2005) (Final
Rule). In Order No. 661-A, the Commission maintained a previously
established date of December 30, 2005 as the date by which public
utilities that own, control, or operate transmission facilities in
interstate commerce are to adopt the tariff sheets in the Final Rule as
amendments to the Large Generator Interconnection Procedures and Large
Generator Interconnection Agreements in their Open Access Transmission
Tariffs. Southern California Edison Company, California Independent
System Operator Corporation, and San Diego Gas and Electric Company
have each submitted motions asking that the December 30, 2005,
compliance date be extended to January 18, 2006, the effective date of
Order No. 661-A.
    By this notice, the Commission hereby extends to January 18, 2006,
the date by which public utilities that own, control, or operate
transmission facilities in interstate commerce are to file the tariff
sheets required by both the Final Rule and Order No. 661-A as
amendments to the Large Generator Interconnection Procedures and Large
Generator Interconnection Agreements in their Open Access Transmission
Tariffs.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-8170 Filed 12-30-05; 8:45 am]

BILLING CODE 6717-01-P


Draft Agenda U. S. Environmental Protection Agency Office of Research and Development BOSC Global Change Subcommittee Conference Call Thursday, August 4, 2005, 10 a. m.   12 noon 10: 00 am Welcome  Introduction of Subcommittee Members Subcommittee Chair  Purpose of BOSC Program Review Subcommittee Vice Chair 10: 15 am Overview of Federal Advisory Committee Act ( FACA) Dr. Janet Gamble ( ORD) Designated Federal Officer 10: 30 am Overview of ORD To Be Determined 10: 45 am Overview of the Global Change Research Program ( GCRP) Dr. Joel Scheraga National Program Director 11: 15 am Review of BOSC Charge Questions Subcommittee Chair  Discussion of Charge Questions Subcommittee 11: 30 am Subcommittee Organization Subcommittee Chair 11: 45 am Public Comments 11: 55 am Administrative Procedures and Action Items Dr. Gamble


[Federal Register Volume 88, Number 68 (Monday, April 10, 2023)]
[Rules and Regulations]
[Pages 21103-21107]
[FR Doc No: 2023-07459]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2021-0274; FRL-10822-01-OCSPP]

Acetophenone; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of acetophenone when used as an inert
ingredient (solvent or co-solvent) in pesticide formulations applied to
growing crops. ADAMA Makhteshim Ltd. submitted a petition to EPA under
the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting the
establishment of this exemption from the requirement of a tolerance.
This regulation eliminates the need to establish a maximum permissible
level for residues of acetophenone, when used in accordance with the
terms of that exemption.

DATES: This regulation is effective April 10, 2023. Objections and
requests for hearings must be received on or before June 9, 2023, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2021-0274, is available at
https://www.regulations.gov or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket) in the Environmental Protection
Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg.,
Rm. 3334, 1301 Constitution Ave. NW, Washington, DC 20460-0001. The
Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room and the OPP docket is<PHONE_NUMBER>. For the latest
status information on EPA/DC services, docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Daniel Rosenblatt, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Office of the Federal Register's e-CFR site at
https://www.ecfr.gov/current/title-40.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2021-0274 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing and must be received by the Hearing Clerk on or before
June 9, 2023. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2021-0274, by one of
the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets#express.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 1, 2021 (86 FR 29229) (FRL-10023-
95), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP IN-11493) by
ADAMA Makhteshim Ltd., 3120 Highwoods Blvd., Suite 100, Raleigh, NC
27604. The petition requested that the existing exemption in 40 CFR
180.920 for residues of acetophenone (CAS Reg. No. 98-86-2) be amended
to include additional uses for acetophenone as a solvent or co-solvent
inert ingredient in pesticide formulations applied to growing crops.
That document referenced a summary of the petition prepared by ADAMA
Makhteshim Ltd., the petitioner, which is available in the docket,
https://www.regulations.gov. There were no comments received in
response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. When making a safety determination for an
exemption for the requirement of a tolerance FFDCA section 408(c)(2)(B)
directs EPA to consider the considerations in section 408(b)(2)(C) and
(D). Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .'' Section 408(b)(2)(D) lists other factors for EPA consideration
making safety determinations, e.g., the validity, completeness, and
reliability of available data, nature of toxic effects, available
information concerning the cumulative effects of the pesticide chemical
and other substances with a common mechanism of toxicity, and available
information concerning aggregate exposure levels to the pesticide
chemical and other related substances, among others.
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no harm to human health. In order
to determine the risks from aggregate exposure to pesticide inert
ingredients, the Agency considers the toxicity of the inert in
conjunction with possible exposure to residues of the inert ingredient
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings. If EPA is able to
determine that a finite tolerance is not necessary to ensure that there
is a reasonable certainty that no harm will result from aggregate
exposure to the inert ingredient, an exemption from the requirement of
a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for acetophenone including exposure
resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with acetophenone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by acetophenone as well as the no-
observed-adverse-effect-level (NOAEL)

and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity
studies are discussed in this unit.
    Available acute studies on acetophenone show moderate oral and low
dermal toxicity. An inhalation toxicity study showed moderate
inhalation toxicity. Acetophenone was shown to be a mild irritant to
the skin and a severe eye irritant but was not reported to be a dermal
sensitizer.
    Several repeat dose oral studies (i.e., a 17-week dietary toxicity
study in rats, a 90-day gavage study in rats, two developmental
toxicity studies in rats and rabbits and a repeat dose toxicity test
combined with a reproductive/developmental screening test in rats) have
been conducted with acetophenone. The most sensitive effect in the
acetophenone database is decreased body weight, which was observed
starting at 300 mg/kg/day in a developmental gavage study in rats and
at 500 mg/kg/day in the 90-day gavage study in rats.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which no adverse effects are observed (the NOAEL)
and the lowest dose at which adverse effects of concern are identified
(the LOAEL). Uncertainty/safety factors are used in conjunction with
the POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.
    No effects attributed to a single exposure were seen in the studies
provided and therefore, a point of departure (POD) for acute dietary
risk was not determined. The most sensitive effect in the acetophenone
database is decreased body weight, which was observed starting at 300
mg/kg/day in a developmental gavage study in rats and at 500 mg/kg/day
in the 90-day gavage study in rats. Therefore, both studies are
considered co-critical. The chronic dietary, incidental oral, dermal
and inhalation endpoints are selected from the NOAEL of 250 mg/kg/day
based on body weight changes observed starting at 300 mg/kg/day in
rats.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to acetophenone, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from acetophenone in food as follows:
    Because no acute endpoint of concern was identified, a quantitative
acute dietary exposure assessment is unnecessary. In conducting the
chronic dietary exposure assessment using the Dietary Exposure
Evaluation Model DEEM-FCID\TM\, Version 4.02, EPA used food consumption
information from the U.S. Department of Agriculture's National Health
and Nutrition Examination Survey, What we eat in America, (NHANES/
WWEIA). This dietary survey was conducted from 2005 to 2010. The Inert
Dietary Exposure Evaluation Model (I-DEEM) is a highly conservative
model with the assumption that the residue level of the inert
ingredient would be no higher than the highest tolerance for a given
commodity. Implicit in this assumption is that there would be similar
rates of degradation between the active and inert ingredient (if any)
and that the concentration of inert ingredient in the scenarios leading
to these highest of tolerances would be no higher than the
concentration of the active ingredient. The model assumes 100 percent
crop treated (PCT) for all crops and that every food eaten by a person
each day has tolerance-level residues. A complete description of the
general approach taken to assess inert ingredient risks in the absence
of residue data is contained in the memorandum entitled ``Update to
D361707: Dietary Exposure and Risk Assessments for the Inerts.'' (12/
21/2021) and can be found at https://www.regulations.gov in docket ID
number EPA-HQ-OPP-2018-0090-0002.
    2. Dietary exposure from drinking water. For the purpose of the
screening level dietary risk assessment to support this request for an
exemption from the requirement of a tolerance for acetophenone, a
conservative drinking water concentration value of 100 ppb based on
screening level modeling was used to assess the contribution to
drinking water for the chronic dietary risk assessments for parent
compound. These values were directly entered into the dietary exposure
model.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., textiles (clothing and diapers), carpets, swimming
pools, and hard surface disinfection on walls, floors, tables). Based
on the pesticide product labels reviewed, in a conservative effort to
assess exposure, the EPA has conducted a screening level assessment
using high-end exposure scenarios for pesticidal use on lawns/turf and
antimicrobial cleaning products.
    Risks were calculated using the Margin of Exposure (MOE) approach.
This is a ratio of the body burden to the toxicological Point of
Departure (POD). A MOE greater than 100 indicates that the exposure
scenario does not demonstrate a risk of concern for acetophenone. For
all residential handler and post-application scenarios, for both adults
and children, for application of pesticides containing this inert
ingredient to lawns and turf and use in cleaning produces, the MOEs
were greater than 100 and therefore, there is no risk of concern.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found acetophenone to share a common mechanism of
toxicity with any other substances, and acetophenone does not appear to
produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
acetophenone does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act (FQPA) Safety Factor (SF). In applying this provision,
EPA either retains the default value of 10X, or uses a different
additional safety factor when reliable data available to EPA support
the choice of a different factor.
    2. Prenatal and postnatal sensitivity. No evidence of offspring
susceptibility was observed in the available developmental studies in
rats and rabbits or the reproductive/developmental toxicity study in
rats. The offspring effects observed in all three studies occurred only
in the presence of maternal toxicity.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced from 10X to 1X. That decision is based on the
following findings:
    i. The toxicity database for acetophenone is complete.
    ii. Acetophenone is a known hypnotic. Clinical signs of
neurotoxicity were observed in the available studies. However, these
effects were seen at the same or higher doses than the body weight
changes. Therefore, the POD is protective of any potential
neurotoxicity effects.
    iii. There is no evidence that acetophenone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to acetophenone in drinking water. EPA used
similarly conservative assumptions to assess post-application exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
acetophenone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
acetophenone is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
acetophenone from food and water will utilize 41.2% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in this unit, regarding residential
use patterns, chronic residential exposure to residues of acetophenone
is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). Acetophenone
is currently used as an inert ingredient in pesticide products that are
registered for uses that could result in short-term residential
exposure, and the Agency has determined that it is appropriate to
aggregate chronic exposure through food and water with short-term
residential exposures to acetophenone.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in aggregate MOEs of 120 for adults
and 110 for children 1 to 2 years old. These MOEs are not of concern
because EPA's level of concern for acetophenone is a MOE of 100 or
below.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
acetophenone is not currently used as an inert ingredient in pesticide
products that are registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
acetophenone.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
structural alerts for carcinogenicity coupled with the result from the
studies indicating low concern for mutagenicity, there is low concern
for carcinogenicity with acetophenone. Therefore, acetophenone is not
expected to pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to acetophenone residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance
established under 40 CFR 180.920 for acetophenone (CAS Reg. No. 98-86-
2) can be amended to include the use as an inert ingredient (solvent or
co-solvent) in pesticide formulations applied pre-harvest to growing
crops only.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the tolerance requirement
under FFDCA section 408(d) in response to a petition submitted to the
Agency. The Office of Management and Budget (OMB) has exempted these
types of actions from review under Executive Order 12866, entitled
``Regulatory Planning and Review'' (58 FR 51735, October 4, 1993).
Because this action has been exempted from review under Executive Order
12866, this action is not subject to Executive Order 13211, entitled
``Actions Concerning

Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or Tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
Tribal Governments, on the relationship between the National Government
and the States or Tribal Governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian Tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999), and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000), do not apply to this action. In addition,
this action does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: March 31, 2023.
Daniel Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, for the reasons stated in the preamble, EPA is amending
40 CFR chapter I as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, amend table 1 to 180.920, by revising the entry
for ``Acetophenone'' to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.

* * * * *

                           Table 1 to 180.920
------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------

                              * * * * * * *
Acetophenone (CAS Reg. No. 98-86-   ..............  Attractant, solvent,
 2).                                                 co-solvent.

                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2023-07459 Filed 4-7-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Rules and Regulations]
[Page 13866]
[FR Doc No: 2018-06561]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2018-0195]

Drawbridge Operation Regulation; Willamette River at Portland, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Hawthorne Bridge across the
Willamette River, mile 13.1, at Portland, OR. The deviation is
necessary to accommodate the Walk MS Portland event. This deviation
authorizes the bridge to remain in the closed-to-navigation position to
allow safe roadway movement of event participants.

DATES: This deviation is effective from 9 a.m. to 11:30 a.m. on April
7, 2018.

ADDRESSES: The docket for this deviation, USCG-2018-0195 is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH.'' Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Steven Fischer, Bridge
Administrator, Thirteenth Coast Guard District; telephone<PHONE_NUMBER>,
email [email protected].

SUPPLEMENTARY INFORMATION: Multnomah County, the bridge owner, has
requested a temporary deviation from the operating schedule for the
Hawthorne Bridge across the Willamette River, mile 13.1, at Portland,
OR. The requested deviation is to accommodate the Walk MS Portland
event. To facilitate this event, the draw of the subject bridge will be
allowed to remain in the closed-to-navigation position and need not
open to marine traffic from 7 a.m. to 11:30 on April 7, 2018. The
Hawthorne Bridge provides a vertical clearance of 49 feet in the
closed-to-navigation position referenced to the vertical clearance
above Columbia River Datum 0.0. The normal operating schedule is in 33
CFR 117.897(c)(3(v). Waterway usage on this part of the Willamette
River includes vessels ranging from commercial tug and barge to small
pleasure craft. The Coast Guard requested objections to this deviation
from local mariners via the Local Notice Mariners, and email. No
objections were submitted to the Coast Guard.
    Vessels able to pass through the bridge in the closed-to-navigation
position may do so at any time. The bridge will be able to open for
emergencies, and there is no immediate alternate route for vessels to
pass. The Coast Guard will inform the users of the waterway, through
our Local and Broadcast Notices to Mariners, of the change in operating
schedule for the bridge so that vessel operators can arrange their
transits to minimize any impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: March 8, 2018.
Steven M. Fischer,
Bridge Administrator, Thirteenth Coast Guard District.
[FR Doc. 2018-06561 Filed 3-30-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: April 21, 2008 (Volume 73, Number 77)]
[Notices]
[Page 21343]
[DOCID:fr21ap08-78]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EC08-66-000]

JPMorgan Chase & Co., The Bear Stearns Companies Inc., and Its
Public Utility Subsidiaries; Notice Amending Prior Notice

April 14, 2008.
    The Commission hereby amends the notice issued April 11, 2008, in
the above-captioned proceeding. Take notice that on April 10, 2008,
JPMorgan Chase & Co., The Bear Stearns Companies Inc., and Bear
Stearns' public utility subsidiaries (Applicants) filed a supplement to
its March 31, 2008, section 203 application. The Applicants state that
the transaction as defined in the application will not have any effect
on the limited sales of reactive power at cost-based rates. In
addition, the Applicants submit a revised Exhibit M to the Application
in lieu of the Exhibit M previously submitted on March 31, 2008.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on April 18, 2008.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
 [FR Doc. E8-8573 Filed 4-18-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)] [Notices] [Pages 52824-52826] [FR Doc No: 2018-22728]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3023-014]

Blackstone Hydro, Inc.; Notice of Application Tendered for Filing

With the Commission and Soliciting Additional Study Requests and

Establishing Procedural Schedule for Relicensing and a Deadline for

Submission of Final Amendments

    Take notice that the following hydroelectric application has been

filed with the Commission and is available for public inspection.

    a. Type of Application: New Major License.

    b. Project No.: P-3023-014.

    c. Date filed: October 1, 2018.

    d. Applicant: Blackstone Hydro, Inc.

    e. Name of Project: Tupperware Hydroelectric Project.

    f. Location: On the Blackstone River in Providence County, Rhode

Island and Worcester County, Massachusetts. No federal lands are

occupied by the project works or located within the project boundary.

    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).

    h. Applicant Contact: Lewis C. Loon, General Manager, Operations

and Maintenance--USA/QC, KEI USA Power Management Inc., 423 Brunswick

Avenue, Gardiner, ME 04345; Phone at<PHONE_NUMBER>, or email at

[email protected].

    i. FERC Contact: Amy Chang at<PHONE_NUMBER>, or

[email protected].

    j. Cooperating agencies: Federal, state, local, and tribal agencies

with jurisdiction and/or special expertise with respect to

environmental issues that wish to cooperate in the preparation of the

environmental document should follow the instructions for filing such

requests described in item l below. Cooperating agencies should note

the Commission's policy that agencies that cooperate in the preparation

of the environmental document cannot also intervene. See, 94 FERC

61,076 (2001).

    k. Pursuant to section 4.32(b)(7) of 18 CFR of the Commission's

regulations, if any resource agency, Indian Tribe, or person believes

that an additional scientific study should be conducted in order to

form an adequate factual basis for a complete analysis of the

application on its merit, the resource agency, Indian Tribe, or person

must file a request for a study with the Commission not later than 60

days from the date of filing of the application, and serve a copy of

the request on the applicant.

    l. Deadline for filing additional study requests and requests for

cooperating agency status: November 30, 2018.

    The Commission strongly encourages electronic filing. Please file

additional study requests and requests for cooperating agency status

using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. For assistance, please contact FERC Online Support

at [email protected],<PHONE_NUMBER> (toll free), or (202)

502-8659 (TTY). In lieu of electronic filing, please send a paper copy

to: Secretary, Federal Energy Regulatory Commission, 888 First Street

NE, Washington, DC 20426. The first page of any filing should include

docket number P-3023-014.

    m. The application is not ready for environmental analysis at this

time.

    n. Project Description: The existing Tupperware Hydroelectric

Project consists of: (1) A 210-foot-long, 12-foot-high arch-type

masonry dam and spillway (Tupperware Dam) with 12-inch-high flashboards

and a crest elevation of 192.8 feet above mean sea level (msl) at the

top of the flashboards; (2) an approximately 2-mile-long impoundment

with a normal maximum elevation of 192.8 feet msl; (3) water conveyance

structures that consist of: (a) An 1,100-foot-long, 60- to 100-foot-

wide power canal located 700 feet upstream of the Tupperware Dam; (b)

an 11.5-acre headpond at a normal maximum elevation of 192.8 feet msl;

(c) a 300-foot-long, 40-foot-wide headrace canal structure; (d) a 46-

foot-long, 16-foot-high headgate dam structure with four 7-foot-high,

8-foot-wide intake gates; and (e) four 8-foot-diameter, 22-foot-long

buried penstocks; (4) a concrete and brick powerhouse containing four

vertical Francis turbine-generator units with a total authorized

capacity of 1,724 kilowatts; (5) a 100-foot-long, 40-foot-wide tailrace

channel that discharges into the Blackstone River; (6) outlet work

structures located upstream of the headgate dam structure in the

headrace canal that consist of: (a) A 37-foot-long, 12-foot-high

emergency spillway with a crest elevation of 196 feet msl located at

the north end of the headrace; (b) two 5-foot-wide, 5-foot-high outlet

gates; (c) a 60-foot-long outlet channel; and (d) two 36-inch-diameter,

150-foot-long concrete conduits that empty into a 190-foot-long, 20-

foot-wide channel that discharges into the Blackstone River downstream

from the tailrace channel; (7) a 90-foot-long, 4.16-kilovolt (kV)

transmission line, a 3,000 kV-amperes step-up transformer, and a 1,300-

foot-long, 13.8-kV transmission line connecting the project generators

to the regional electric grid; and (8) appurtenant facilities.

    The project bypasses approximately 1 mile of the Blackstone River,

and there is currently no required minimum instream flow for the

bypassed reach. Blackstone Hydro operates the project in a run-of-river

(ROR) mode with an annual average generation of approximately 4,027

megawatt-hours.

    Blackstone Hydro proposes to: (1) continue operating the project in

a ROR mode; (2) provide a year-round minimum flow of 35 cubic feet per

second into the bypassed reach; (3) provide upstream eel passage at the

project, following installation of an upstream eel passage facility at

the downstream Woonsocket Falls Project No. 2972; (4) implement

nighttime turbine shutdowns to facilitate downstream eel passage; and

(5) develop procedures for operating the outlet gates to address water

quality in the power canal.

    o. A copy of the application is available for review at the

Commission in the Public Reference Room or may be viewed on the

Commission's website at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the

docket number field to access the document. For assistance, contact

FERC Online Support. A copy is also available for inspection and

reproduction at the address in item h above.

    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp to be notified via email of new filings and issuances

related to this or other pending projects. For assistance, contact FERC

Online Support.

    p. Procedural schedule and final amendments: The application will

be processed according to the following preliminary schedule. Revisions

to the schedule will be made as appropriate.

Issue Deficiency Letter (if necessary)...............     December 2018.

Request Additional Information.......................     December 2018.

Issue Acceptance Letter..............................        March 2019.

Issue Scoping Document 1 for comments................        April 2019.

Request Additional Information (if necessary)........         June 2019.

Issue Scoping Document 2.............................         July 2019.

Issue Notice of Ready for Environmental Analysis.....         July 2019.

Commission issues Environmental Assessment...........      January 2020.

    q. Final amendments to the application must be filed with the

Commission no later than 30 days from the issuance date of the notice

of ready for environmental analysis.

    Dated: October 12, 2018.

Kimberly D. Bose,

Secretary.

[FR Doc. 2018-22728 Filed 10-17-18; 8:45 am]

BILLING CODE 6717-01-P