[Federal Register Volume 87, Number 55 (Tuesday, March 22, 2022)]
[Notices]
[Pages 16172-16173]
[FR Doc No: 2022-06026]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP22-702-000.
    Applicants: Northern Border Pipeline Company.
    Description: Sec. 4(d) Rate Filing: Sequent Energy Management, LLC
Name Change Clean up to be effective 3/15/2022.
    Filed Date: 3/15/22.
    Accession Number: 20220315-5155.
    Comment Date: 5 p.m. ET 3/28/22.

    Docket Numbers: RP22-703-000.
    Applicants: Elba Express Company, L.L.C.
    Description: Compliance filing: Annual Interruptible Revenue
Crediting Report 2022 to be effective N/A.
    Filed Date: 3/16/22.
    Accession Number: 20220316-5009.
    Comment Date: 5 p.m. ET 3/28/22.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP16-1022-002.
    Applicants: Colorado Interstate Gas Company, L.L.C.
    Description: Compliance filing: Second Petition to Amend Docket No.
RP16-1022 Stipulation and Agreement to be effective N/A.
    Filed Date: 3/15/22.
    Accession Number: 20220315-5176.
    Comment Date: 5 p.m. ET 3/22/22.

    Docket Numbers: RP17-972-003.

    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Wyoming Interstate Company, L.L.C. submits tariff
filing per 154.203: Second Petition to Amend Docket No. RP17-972
Stipulation and Agreement to be effective N/A.
    Filed Date: 3/15/22.
    Accession Number: 20220315-5181.
    Comment Date: 5 p.m. ET 3/22/22.

    Docket Numbers: RP19-276-003.
    Applicants: Young Gas Storage Company, Ltd.
    Description: Young Gas Storage Company, Ltd. submits tariff filing
per 154.203: Second Petition to Amend Docket No. RP19-276 Stipulation
and Agreement to be effective N/A.
    Filed Date: 3/15/22.
    Accession Number: 20220315-5177.
    Comment Date: 5 p.m. ET 3/22/22.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at https://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: March 16, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-06026 Filed 3-21-22; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 19, 2008 (Volume 73, Number 161)]
[Proposed Rules]
[Page 48351-48352]
[DOCID:fr19au08-32]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 131

[EPA-HQ-OW-2008-0495; FRL-8706-8]

Withdrawal of the Federal Water Quality Standards Use
Designations for Soda Creek and Portions of Canyon Creek, South Fork
Coeur d'Alene River, and Blackfoot River in Idaho

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to take direct final action to withdraw the
Federal water quality standards designating cold water biota uses for
Soda Creek and portions of Canyon Creek, South Fork Coeur d'Alene
River, and Blackfoot River in Idaho. In July 1997, EPA promulgated a
Federal rule designating uses for water bodies in the State of Idaho,
including the designation of cold water biota for Soda Creek, and
portions of Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot
River, with the exception of any portion in Indian country. These
Federal water quality standards designating cold water biota uses are
no longer necessary since EPA approved Idaho's adopted uses that result
in protection for cold water biota. EPA is also withdrawing the water
quality standards variance provision applicable to these uses (40 CFR
131.33(d)), because this provision is no longer necessary with the
withdrawal of the Federal water quality standards designating these
uses.

DATES: Written comments must be received by September 18, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-OW-
2008-0495, by one of the following methods:
     www.regulations.gov: Follow the on-line instructions for
submitting comments.
     E-mail<EMAIL_ADDRESS>     Mail to either: Water Docket, U.S. Environmental
Protection Agency, Mailcode: 2822T, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460 or Lisa Macchio, U.S. EPA, Region 10, Mailcode:
OWW-131, 1200 Sixth Avenue, Suite 900, Seattle, Washington 98101,
Attention: Docket ID No. EPA-HQ-OW-2008-0495.
     Hand Delivery: EPA Docket Center, EPA West Room 3334, 1301
Constitution Avenue, NW., Washington, DC 20004 or Lisa Macchio, U.S.
EPA, Region 10, 1200 Sixth Avenue, Suite 900, Seattle, WA 98101,
Attention Docket ID No. EPA-HQ-OW-2008-0495. Such deliveries are only
accepted during the Docket's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2008-
0495. EPA's policy is that all comments received will be included in
the public docket without change and may be made available online at
www.regulations.gov, including any personal information provided,
unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through www.regulations.gov or e-mail.
The www.regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through www.regulations.gov
your e-mail address will be automatically captured and included as part
of the comment that is placed in the public docket and made available
on the Internet. If you submit an electronic comment, EPA recommends
that you include your name and other contact information in the body of
your comment and with any disk or CD-ROM you submit. If EPA cannot read
your comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.
    Docket: All documents in the docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at two docket facilities. The OW
Docket Center is open from 8:30 until 4:30 p.m., Monday through Friday,
excluding legal holidays. The OW Docket Center telephone number is
(202) 566-2426, and the Docket address is OW Docket, EPA West, Room
3334, 1301 Constitution Avenue, NW., Washington, DC 20004. 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 is<PHONE_NUMBER>. Publicly available docket materials are
also available in hard copy at U.S. EPA, Region 10, 1200 Sixth Avenue,
Suite 900, Seattle, WA 98101. Docket materials can be accessed from 9
a.m. until 3 p.m., Monday through Friday, excluding legal holidays. The
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Wendy Drake, U.S. EPA Headquarters,
Office of Water, Mailcode: 4305T, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number: 202-
566-0409; e-mail address<EMAIL_ADDRESS>or Lisa Macchio, U.S.
EPA, Region 10, Mailcode: OWW-131, 1200 Sixth Avenue, Suite 900,
Seattle, Washington 98101; telephone number:<PHONE_NUMBER>; fax number:
206-553-0165; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This action concerns EPA's withdrawal of the
Federal water quality standards designating cold water biota uses for
Soda Creek and portions of Canyon Creek, South Fork Coeur d'Alene
River, and Blackfoot River in Idaho. In the ``Rules and Regulations''
section of this Federal Register, we are withdrawing the Federal water
quality standards designating cold water biota uses for Soda Creek and
portions of Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot
River in Idaho and the water quality standards variance provision
related to these uses as a direct final rule without a prior proposed
rule. If we receive no adverse comment, we will not take further action
on this proposed rule.
    In July 1997, EPA promulgated a Federal rule designating uses for
water bodies in the State of Idaho, including the designation of cold
water biota for Soda Creek, and portions of Canyon Creek, South Fork
Coeur d'Alene River, and Blackfoot River, with the exception of any
portion in Indian country (62 FR 41183, July 31, 1997). In March 2000,
Idaho adopted a revised use for a segment of Blackfoot River, which
changed from ``Protected for Future Use'' to undesignated. In Idaho,
undesignated waters are protected for all recreational use in and on
the water and for the propagation of fish, shellfish, and wildlife
(IDAPA <IP_ADDRESS>.01). In March 2002, Idaho adopted a use designation
of cold water biota for segments of Canyon Creek and South Fork Coeur
d'Alene River. In March 2006, Idaho adopted a revised

use for Soda Creek, which changed from ``NONE'' to undesignated. As
described in the undesignated surface waters provision of Idaho's Water
Quality Standards (IDAPA <IP_ADDRESS>.01a), the Idaho Department of
Environmental Quality (IDEQ) applies cold water aquatic life criteria
to undesignated waters because it is presumed that most waters in the
State will support cold water aquatic life. Thus, cold water aquatic
life criteria now apply to Soda Creek and the segment of the Blackfoot
River. EPA approved Idaho's revised water quality standards for
segments of Canyon Creek and South Fork Coeur d'Alene River on June 24,
2005, and for Soda Creek on August 15, 2006. EPA approved Idaho's
revised water quality standards for the segment of the Blackfoot River,
except for any portion in Indian country, on August 22, 2006. Thus, the
Federal water quality standards designating Soda Creek and portions of
Canyon Creek, South Fork Coeur d'Alene River, and Blackfoot River for
cold water biota use (40 CFR 131.33(b)) is no longer necessary, and EPA
is withdrawing it with this action. EPA is also withdrawing the water
quality standards variance provision applicable to these uses (40 CFR
131.33(d)), because this provision is no longer necessary with the
withdrawal of the Federal water quality standards designating these
uses.
    For further information, including the regulatory text and various
statutes and executive orders that require findings for rulemakings,
please see the information provided in the direct final rule titled,
``Withdrawal of the Federal Water Quality Standards Use Designations
for Soda Creek and Portions of Canyon Creek, South Fork Coeur d'Alene
River, and Blackfoot River in Idaho'' located in the ``Rules and
Regulations'' section of this Federal Register publication.

I. Why EPA Is Issuing This Proposed Rule

    This document proposes to withdraw the Federal water quality
standards designating cold water biota uses for Soda Creek and portions
of Canyon Creek, Blackfoot River, and South Fork Coeur d'Alene River in
Idaho. We have published a direct final rule withdrawing the Federal
water quality standards designating the cold water biota uses in the
``Rules and Regulations'' section of this Federal Register because we
view this as a noncontroversial action and anticipate no adverse
comment. We have explained our reasons for this action in the preamble
to the direct final rule.
    If we receive no adverse comment, we will not take further action
on this proposed rule. If we receive adverse comment, we will withdraw
the direct final rule and it will not take effect. We would address all
public comments in any subsequent final rule based on this proposed
rule.
    We do not intend to institute a second comment period on this
action. Any parties interested in commenting must do so at this time.
For further information, please see the information provided in the
ADDRESSES section of this document.

II. What Entities May Be Affected by This Action?

    Citizens concerned with water quality in Idaho may be interested in
this rulemaking. Entities discharging pollutants to Soda Creek, Canyon
Creek, South Fork Coeur d'Alene, and Blackfoot River in Idaho could be
indirectly affected by this rulemaking because water quality standards
are used in determining National Pollutant Discharge Elimination System
(NPDES) permit limits. Because this action withdraws the Federal water
quality standards designating cold water biota uses that are no longer
necessary since EPA approved Idaho's adopted uses that result in
protection for cold water biota, the effect of this rulemaking may only
occur when entities seek variances to water quality standards. Entities
seeking variances from use designations on these waters will now apply
to the state, and EPA will act on the state's decision to grant the
variance.
    Categories and entities that may ultimately be affected include:

------------------------------------------------------------------------
                                               Examples of potentially
                 Category                         affected entities
------------------------------------------------------------------------
Industry..................................  Industries discharging
                                             pollutants to Soda Creek,
                                             Canyon Creek, South Fork
                                             Coeur d'Alene River, and
                                             Blackfoot River in Idaho.
Municipalities............................  Publicly owned treatment
                                             works discharging
                                             pollutants to Soda Creek,
                                             Canyon Creek, South Fork
                                             Coeur d'Alene River, and
                                             Blackfoot River in Idaho.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding NPDES regulated entities likely to be
affected by this action. This table lists the types of entities that
EPA is now aware could potentially be affected by this action.

List of Subjects in 40 CFR Part 131

    Environmental protection, Intergovernmental relations, Reporting
and recordkeeping requirements, Water pollution control, Water quality
standards.

    Dated: August 13, 2008.
Stephen L. Johnson,
Administrator.
 [FR Doc. E8-19199 Filed 8-18-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Proposed Rules]
[Pages 16350-16353]
[FR Doc No: 2011-6621]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2010-N-0029]

Medical Devices; Ovarian Adnexal Mass Assessment Score Test
System; Labeling; Black Box Restrictions

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the regulation classifying ovarian adnexal mass assessment score test
systems to restrict these devices so that a prescribed warning
statement that addresses a risk identified in the special controls
guidance document must be in a black box and must appear in all
labeling, advertising, and promotional material. The black box warning
mitigates the risk to health associated with off-label use as a
screening test, stand-alone diagnostic test, or as a test to determine
whether or not to proceed with surgery. Elsewhere in this issue of the
Federal Register, FDA is announcing a final rule that classifies the
ovarian adnexal mass assessment score test system into class II
(special controls).

DATES: Submit either electronic or written comments by May 23, 2011.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2010-
N-0029, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2010-N-0029. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Scott McFarland, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5543, Silver Spring, MD 20993-0002, 301-
796-6217.

SUPPLEMENTARY INFORMATION:

I. What is the background of this proposed rule?

A. Ovarian Adnexal Mass Assessment Score Test System

    An ovarian adnexal mass assessment score test system measures one
or more analytes in serum and combines the values into a single score
that is then used to determine the likelihood that the pre-surgical
adnexal mass in a woman not yet referred to an oncologist, is
malignant. An ovarian adnexal mass assessment score test system is
intended for use in those patients for whom surgery is planned, and
should not be used to decide whether or not a patient should receive
surgery. The test is used in conjunction with a clinical and
radiological evaluation of the patient by physicians in determining
whether the patient should be referred to a gynecologic oncologist for
surgery.

B. Identified Risk to Health

    The ovarian adnexal mass assessment score test system is not
indicated for use as a screening or diagnostic test for ovarian cancer.
Off-label use of the test (e.g., in patients who are not already

identified as needing surgery for pelvic mass or without reference to
an independent clinical/radiological evaluation of the patient), may
lead to a high frequency of unnecessary further testing and surgery due
to false positive results, or to delay in tumor diagnosis due to false
negative results.

II. Why is FDA proposing to require black box warnings on ovarian
adnexal mass assessment score test system labeling, advertising, and
promotional material?

    FDA has determined that in order to provide reasonable assurance of
safety and effectiveness, it is necessary to restrict the ovarian
adnexal mass assessment score test system to sale, distribution, and
use with labeling, advertising, and promotional material that bears a
warning statement in a black box that alerts users to the risk
associated with off-label use as a screening test, stand-alone
diagnostic test, or as a test to determine whether or not to proceed
with surgery. While FDA is establishing as a special control ``Guidance
for Industry and FDA Staff; Class II Special Controls Guidance
Document: Ovarian Adnexal Mass Assessment Score Test System'' which
recommends a black box warning to address the risk of off-label use,
FDA believes it is necessary to require this warning in labeling and
advertising by restricting the device under section 520(e) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360j(e)). A
notice of availability of this special controls guidance document is
published elsewhere in this issue of the Federal Register.
    In cases in which class II and class III devices have significant
risks that would make the devices unsafe if used inappropriately, FDA
believes the risks need to be explained in warning statements placed in
a black box that is displayed prominently in the labeling, advertising,
and promotional material to ensure awareness by the end user. Awareness
of these important risks by the end user enables these devices to be
used safely. In this case, a prominent black box warning, which alerts
the user to the limitations of this device, is necessary in all
labeling, advertising, and promotional materials to allow ovarian
adnexal mass assessment score test system devices to be used safely.
The proposed prominent black box warning would read as follows:
[GRAPHIC] [TIFF OMITTED] TP23MR11.000

III. What is the legal authority for this proposed rule?

    FDA is issuing this proposed rule under the authority of section
520(e) of the FD&C Act, which authorizes FDA to restrict sale,
distribution, and use of devices upon certain conditions. FDA is also
issuing this proposed rule under general device and administrative
provisions of the FD&C Act (sections 501, 510, 513, 515, 520, and 701
(21 U.S.C. 351, 360, 360c, 360e, 360j, and 371, respectively)).

IV. What is the environmental impact of this proposed rule?

    FDA has determined under 21 CFR 25.34(b) and (f) that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

V. What is the economic impact of this proposed rule?

    FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs Agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The Agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because this proposed rule would strengthen existing
cautions against misuse of a new product, the Agency proposes to
certify that the final rule will not have a significant economic impact
on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    An ovarian adnexal mass assessment test system is a device that
measures one or more proteins in serum to yield a single result for the
likelihood that an adnexal pelvic mass in a woman is malignant. Such a
test would identify women whose planned gynecologic surgery would
benefit from referral to a gynecological oncologist, despite negative
results from other clinical and radiographic tests for ovarian cancer.
    In considering the appropriate level of regulatory oversight for
this device, FDA concluded in classifying the device that general and
special controls to minimize the risk of false positive and false

negative results, and risks associated with improper off-label use
would provide a reasonable assurance of safety and effectiveness of the
ovarian adnexal mass assessment test system. The special controls
guidance recommends use of a black box warning to minimize these risks.
Without such a strong warning, ovarian adnexal mass assessment test
systems might be used as a screening test, stand-alone diagnostic test,
or as a test to determine whether or not to proceed with surgery. Off-
label use of the test or the use of test results without consideration
of other diagnostic testing and clinical assessment could pose a risk
for morbidity and mortality due to nonreferral for oncologic evaluation
and treatment.
    In order to require the specific black box warning on labeling and
on all advertising and promotional materials for the device, FDA is
issuing this proposed rule under section 520(e) of the FD&C Act.
Through this action, the Agency proposes to require a black box warning
on product labeling, advertising, and promotional materials for ovarian
adnexal mass assessment test systems. This warning would make users
aware of the limitations of this device and the serious risks
associated with its misuse. With the proposed addition of this black
box warning to product labeling, advertising, and marketing materials,
the Agency concludes there would be a reasonable assurance of the
safety and effectiveness of ovarian adnexal mass assessment test
systems.
    The economic impact of this proposed rule is expected to be very
small. We are aware of a single manufacturer producing a single product
that would be affected by this black box warning. The manufacturer
should be able to incorporate the warning in the course of developing
its product labeling. The admonition against off-label use for this
device already exists, so the addition of this type of warning is not
expected to have a significant effect on the market for this product.
The expected impact of this proposal on the market for this product
would be a reduction in off-label use among the small number of users
who would be undeterred by a less visible warning.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. This proposal would impose almost no cost on
manufacturers. The proposed black box warning would strengthen an
existing admonition against off-label use and would not significantly
affect usage. Impacts on any entities would be so small as to be
difficult to quantify. For these reasons, the Agency proposes to
certify that this rule would not have a significant economic impact on
a substantial number of small entities.

VI. How does the Paperwork Reduction Act of 1995 apply to this proposed
rule?

    FDA concludes that labeling provisions of this proposed rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the
black box warning on all labeling, advertising, and promotional
materials for ovarian adnexal mass assessment score test system devices
is a ``public disclosure of information originally supplied by the
Federal Government to the recipient for the purpose of disclosure to
the public.'' (see 5 CFR 1320.3(c)(2)).

VII. What are the federalism impacts of this proposed rule?

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires Agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' Federal law includes an express preemption
provision that preempts certain State requirements ``different from or
in addition to'' certain Federal requirements applicable to devices (21
U.S.C. 360k; See Medtronic v. Lohr, 518 U.S. 470 (1996); Riegel v.
Medtronic, Inc., 552 U.S. 312 (2008)). If this proposed rule is made
final, the final rule would create a requirement under 21 U.S.C. 360k
for a black box warning statement that must appear in all advertising,
labeling, and promotional material for ovarian adnexal mass assessment
score test systems.

VIII. How do you submit comments on this proposed rule?

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 866 as follows.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

    1. The authority citation for 21 CFR part 866 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

    2. In Sec.  866.6050 of subpart G, add new paragraph (c) to read as
follows:

Sec.  866.6050  Ovarian adnexal mass assessment score test system.

* * * * *
    (c) Black Box Warning. Under section 520(e) of the Federal Food,
Drug, and Cosmetic Act these devices are subject to the following
restriction: A warning statement must be placed in a black box and must
appear in all advertising, labeling, and promotional material for these
devices. That warning statement must read:

[GRAPHIC] [TIFF OMITTED] TP23MR11.001

    Dated: March 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6621 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 31, 2006 (Volume 71, Number 104)]
[Rules and Regulations]
[Page 30811-30818]
[DOCID:fr31my06-10]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2005-0215; FRL-8057-9]

Terbacil; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for combined residues
of terbacil in or on watermelon. The Interregional Research Project
Number 4 (IR-4), on behalf of the registrant, DuPont Crop Protection,
requested this tolerance under the Federal Food, Drug, and Cosmetic Act
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).
EPA is also deleting an existing time-limited terbacil tolerance that
is no longer needed as a result of this action.

DATES:  This regulation is effective May 31, 2006. Objections and
requests for hearings must be received on or before July 31, 2006, 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:  EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2005-0215. All documents in the
docket are listed in the index for the docket. Although listed in the
index, some information is not publicly available, e.g., 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 in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Docket Facility is (703) 305-
5805.

FOR FURTHER INFORMATION CONTACT: Sidney Jackson, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS 111), e.g., agricultural workers;
greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS 112), e.g., cattle ranchers and
farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS 32532), e.g., agricultural
workers; commercial applicators; farmers; greenhouse, nursery, and
floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under  FOR FURTHER INFORMATION
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this Federal Register document

electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a

frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr.
 To access the OPPTS Harmonized Guidelines

referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm
.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2005-0215 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before July 31, 2006.
    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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2005-0215, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
telephone number for the Docket Facility is<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of September 7, 2005 (70 FR 53180) (FRL-
7731-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
3E6640) by IR-4, on behalf of DuPont Crop Protection, P.O. Box 30,
Newark, Delaware 19714-0030. The petition requested that 40 CFR 180.209
be amended by establishing a tolerance for combined residues of the
herbicide terbacil, (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], in or on watermelon at 1.0 parts per million (ppm).
That notice included a summary of the petition prepared by DuPont Crop
Protection, the registrant. There were no comments received in response
to the notice of filing.
    EPA is also deleting an established tolerance in section 40 CFR
180.209(b) that is no longer needed, as a result of this action. The
tolerance deletion under section 40 CFR 180.209(b) is a time-limited
tolerance established under section 18 emergency exemptions that is
superceded by the establishment of a general tolerance for terbacil
section 40 CFR 180.209(a). The revision to 40 CFR 180.209 is as follow:
    Delete the time-limiting tolerance for watermelon at 0.4 ppm under
40 CFR 180.209(b). Tolerance for watermelon at 1.0 ppm is established
by this action under 40 CFR 180.209(a).
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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(b)(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.
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....''
    EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 of the FFDCA and a complete
description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/
 1997/November/Day-26/p30948.htm.

III. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D) of FFDCA, 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, consistent with section
408(b)(2) of FFDCA, for a tolerance for combined residues of terbacil
on watermelon at 1.0 ppm. EPA's assessment of exposures and risks
associated with establishing the tolerance 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 toxic effects caused by terbacil as well as the no observed
adverse effect level (NOAEL) and the lowest observed adverse effect
level (LOAEL) from available toxicity studies as summarized in Table 1
below:

 Table 1: Toxicity Profile for Terbacil -- Subchronic, Chronic and Other
                                Toxicity
------------------------------------------------------------------------
          Guideline No.               Study Type      Assessment Results
------------------------------------------------------------------------
870.3100                          90-Day oral         NOAEL = 500 ppm
                                   toxicity rat        (20 mg/kg/day)
                                  Dosage at 0, 8,     LOAEL = 5,000 ppm
                                   20, and 200         (200 mg/kg/day),
                                   milligrams/         based on focal
                                   kilogram/day (mg/   necrosis and
                                   kg/day).            triaditis in
                                                       females (F),
                                                       vacuolization in
                                                       males (M) and
                                                       increased
                                                       relative liver
                                                       weight and
                                                       hypertrophy of
                                                       hepatocytes in
                                                       both sexes.
------------------------------------------------------------------------
870.3200                          21-Day dermal       NOAEL = 5,000 mg/
                                   rabbit              kg/day
                                  Dosage at 0 and     LOAEL was not
                                   5,000 mg/kg/day.    established.
                                                       There were no
                                                       clinical signs of
                                                       toxicity, gross
                                                       or
                                                       histopathologic
                                                       changes.
------------------------------------------------------------------------
870.4100                          Chronic oral 2-     NOAEL = 250 ppm
                                   year dog            (equivalent to
                                  Dosage at 0, 1.0,    5.0 mg/kg/day)
                                   5.0, 50, and 200   LOAEL = 2500 ppm
                                   mg/kg/day.          (equivalent to 50
                                                       mg/kg/day), based
                                                       on increased
                                                       relative thyroid
                                                       weights and
                                                       thymic involution
                                                       in both sexes.
------------------------------------------------------------------------
870.4200                          Carcinogenicity     NOAEL = 162 mg/kg/
                                   mouse               day
                                  Dosage for M/F: 0/  LOAEL = 746 mg/kg/
                                   0, 6.5/8.0, 162/    day, based on
                                   199, and 746/895    increased liver
                                   mg/kg/day.          weights,
                                                       hyperplastic
                                                       nodules,
                                                       necrosis, and
                                                       vacuolation in
                                                       the liver in
                                                       males.
                                                      There was no
                                                       oncogenic
                                                       potential at the
                                                       doses tested.
------------------------------------------------------------------------
870.3700                          Developmental       Maternal NOAEL was
                                   toxicity rat        not established
                                  Dosage at 0, 24,    Maternal LOAEL =
                                   104 and 392 mg/kg/  24 mg/kg/day
                                   day.                based on
                                                       decreased body
                                                       weight gain.
                                                      Developmental
                                                       NOAEL = 24 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 104 mg/kg/
                                                       day, based on
                                                       decreased number
                                                       of live fetuses/
                                                       litter.
------------------------------------------------------------------------
870.3700                          Developmental       Maternal NOAEL =
                                   Toxicity rabbit     200 mg/kg/day
                                  Dosage at 0, 30,    Maternal LOAEL =
                                   200, and 600 mg/    600 mg/kg/day,
                                   kg/day.             based on
                                                       mortality,
                                                       clinical findings
                                                       (anorexia,
                                                       discharge),
                                                       decreased body
                                                       weight and body
                                                       weight gain.
                                                      Developmental
                                                       NOAEL = 200 mg/kg/
                                                       day
                                                      Developmental
                                                       LOAEL = 600 mg/kg/
                                                       day, based on
                                                       decreased body
                                                       weight, increased
                                                       incidence of
                                                       skeletal
                                                       malformations
                                                       (fused ribs) and
                                                       increase
                                                       frequency of
                                                       skeletal
                                                       variations.
------------------------------------------------------------------------

870.3800                          3-generation        Parental NOAEL =
                                   reproduction -      50 ppm
                                   rat                 (equivalent to2.0
                                  Dosage at 0, 2.0,    mg/kg/day)
                                   and 10 mg/kg/day.  Parental LOAEL =
                                                       250 ppm
                                                       (equivalent to 10
                                                       mg/kg/day) based
                                                       on decreased body
                                                       weight,
                                                      Reproductive NOAEL
                                                       = 250 ppm
                                                       (equivalent to 10
                                                       mg/kg/day)
                                                      Reproductive LOAEL
                                                       was not
                                                       established
                                                       Offspring NOAEL =
                                                       250 ppm
                                                       (equivalent to 10
                                                       mg/kg/day)
                                                      Offspring LOAEL
                                                       was not
                                                       established
------------------------------------------------------------------------
870.4300                          Combined Chronic    NOAEL (M/F)= 58/
                                   Toxicity/           1.4 mg/kg/day
                                   Carcinogenicity    LOAEL (M/F)= 308/
                                   rat                 83 mg/kg/day,
                                  Dosage M/F: 0/0,     based on
                                   0.9/1.4, 58/83,     decreased body
                                   308/484 mg/kg/day.  weight and body
                                                       weight gain and
                                                       increased
                                                       absolute and
                                                       relative liver
                                                       weights in males
                                                       and females.
                                                       There was no
                                                       oncogenic
                                                       potential at the
                                                       doses tested.
------------------------------------------------------------------------
870.4300                          Combined Chronic    Systemic NOAEL =
                                   Toxicity/           250 ppm
                                   Carcinogenicity     (equivalent to 10
                                   rat                 mg/kg/day)
                                  Dosage at 0, 2.0,   Systemic LOAEL =
                                   10 and 100/400 mg/  2,500/10,000 ppm
                                   kg/day).            (equivalent to
                                                       100/400 mg/kg/
                                                       day) based on
                                                       increased mean
                                                       relative liver
                                                       weights,
                                                       hepatocyte
                                                       centrilobular
                                                       hypertrophy in
                                                       males and females
                                                       and vacuolation
                                                       in females. There
                                                       was no oncogenic
                                                       potential at the
                                                       doses tested.
------------------------------------------------------------------------
870.5300                          Mutagenic- (HGPRT)  Did not induce
                                  Dosage at 0, 2, 3,   mutation in
                                   5 and 6 mM (-S9);   chinese hamster
                                   0, 1, 2, 2.5,       ovary cells with
                                   2.75, 3.25 and      or without
                                   3.50 mM (+S9).      metabolic
                                                       activation.
------------------------------------------------------------------------
870.5375                          In vitro            Negative for
                                   chromosome          clastogenic
                                   aberration assay    activity in the
                                   CHO cells           rat bone marrow
                                  Dosage at 0, 20,     cytogenetic
                                   100 and 500 mg/kg.  assay.
------------------------------------------------------------------------
870.5500                          Unscheduled DNA     Did not induce
                                   synthesis assay     unscheduled DNA
                                   rat primary         synthesis in
                                   hepatocyte          primary rat
                                  Dosage at 0,         hepatocytes.
                                   0.010, 0.033,
                                   0.10, 0.33, 1.0,
                                   2.5, 5.0, 7.5,
                                   and 10 mM.
------------------------------------------------------------------------
870.5100                           Mutagenicity       Did not show the
                                   study               suspected (5-
                                   (bacteriophage      bromo-uracil
                                   assay)              metabolite)
                                                       mutagenic action.
------------------------------------------------------------------------
870.7485                          Metabolism study    Approximately 57-
                                   rat                 82% of the
                                  Doseage at single    administered dose
                                   doses of 6.5 or     was absorbed in
                                   500 mg/kg.          24 hours. Ninety
                                                       one to 103% of
                                                       radioactivity was
                                                       recovered within
                                                       5 days; with 70
                                                       to 86% in urine
                                                       and 14-28% in
                                                       feces. The major
                                                       metabolites were
                                                       glucuronide,
                                                       sulfate and
                                                       sulfate/N-
                                                       acetylcysteine
                                                       conjugates. The
                                                       primary metabolic
                                                       pathway is
                                                       hydroxylation of
                                                       the 6-methyl
                                                       group to form the
                                                       alcohol which is
                                                       conjugated to
                                                       form the
                                                       glucuronide (35%
                                                       of the dose) and
                                                       the sulfate
                                                       derivatives
                                                       (11%). Terbacil
                                                       is also
                                                       metabolized to
                                                       the 5-hydroxy
                                                       intermediate,
                                                       which is further
                                                       conjugated to
                                                       form a sulfate
                                                       derivative (17%).
                                                       There was no
                                                       evidence
                                                       suggestive of
                                                       bioaccumulation.
------------------------------------------------------------------------

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the dose at which the NOAEL from the toxicology study
identified as appropriate for use in risk assessment is used to
estimate the toxicological level of concern (LOC). However, the LOAEL
is sometimes used for risk assessment if no NOAEL was achieved in the
toxicology study selected. An uncertainty factor (UF) is applied to
reflect uncertainties inherent in the extrapolation from laboratory
animal data to humans and in the variations in sensitivity among
members of the human population as well as other unknowns.
    The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify non-threshold hazards such as
cancer. The Q* approach assumes that any amount of exposure will lead
to some degree of cancer risk, estimates risk in terms of the
probability of occurrence of additional cancer cases. More information
can be found on the general principles EPA uses in risk

characterization at http://www.epa.gov/pesticide/health/human.htm.

    A summary of the toxicological endpoints for terbacil used for
human risk assessment is presented in the following Table 2:

       Table 2.--Summary of Toxicological Dose and Endpoints for terbacil for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                          Dose Used in Risk
                                             Assessment,          Special FQPA SF and
          Exposure/Scenario                Interspecies and       Level of Concern for   Study and Toxicological
                                         Intraspecies and any       Risk Assessment              Effects
                                            Traditional UF
----------------------------------------------------------------------------------------------------------------
Acute Dietary                          NA                       NA                       An endpoint of concern
(General Population and Females 13-50                                                     attributable to a
 years of age).                                                                           single dose for the
                                                                                general population or
                                                                                female 13+ was not
                                                                                identified
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)      NOAEL= 1.4 mg/kg/day     Special FQPA SF = 1X     Combined Chronic
                                       UF = 100X..............  cPAD = cRfD divided by.   Toxicity/
                                       Chronic RfD = cRfD=      Special FQPA SF........   carcinogenicity - rat
                                        0.014 mg/kg/day.         = 0.014 mg/kg/day.....  LOAEL = 83 mg/kg/day
                                                                                based on decreased
                                                                                body weight and body
                                                                                weight gain in females
----------------------------------------------------------------------------------------------------------------
Short (1-30 days) and Intermediate (1- Oral NOAEL = 2.0 mg/kg/  LOC for margin of        3-Generation
 6 months) Term Incidental oral         day (inhalation          exposure (MOEs) < 100     reproduction - rat
                                        absorption rate = 100%   (occupational and       LOAEL = 10 mg/kg/day
                                        oral equivalent)         residential)             based on decreased
                                                                                body weight
----------------------------------------------------------------------------------------------------------------
Dermal (any time period)               NA                       NA                       Quantification of
                                                                                dermal risk is not
                                                                                required; the lack of
                                                                                dermal or systemic
                                                                                toxicity at 5,000 mg/
                                                                                kg (5X the limit dose)
                                                                                in a 21 day dermal
                                                                                toxicity study in rats
                                                                                which indicates poor
                                                                                dermal absorption.
----------------------------------------------------------------------------------------------------------------
Short- (1 to 30 days) and              NOAEL= 2.0 mg/kg/day     LOC for MOEs < 100        3-Generation
 Intermediate- (1 to 6 months) term     (inhalation absorption   (residential)            reproduction - rat
 inhalation                             rate = 100% oral                                 LOAEL = 10 mg/kg/day,
                                        equivalent)                                       based on decreased
                                                                                body weight
----------------------------------------------------------------------------------------------------------------
Long-term inhalation (> 6 months)      Oral NOAEL= 1.4 mg/kg/   LOC for MOE <100         Combined Chronic
                                        day (inhalation          (residential and         Toxicity/Carcinogeni-
                                        absorption rate = 100%   occupational)            city - rat
                                        oral equivalent)                                 LOAEL = 83 mg/kg/day
                                                                                based on decreased
                                                                                body weight and body
                                                                                weight gain in females
----------------------------------------------------------------------------------------------------------------
Cancer (oral, dermal, inhalation)      NA                       NA                       Classification: Not
                                                                                likely to be
                                                                                carcinogenic to humans
----------------------------------------------------------------------------------------------------------------

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. Tolerances have been
established (40 CFR 180.209) for the combined residues of terbacil, in
or on a variety of raw agricultural commodities. Tolerances are
currently established for the combined residues of terbacil, (3-tert-
butyl-5-chloro-6-methyluracil) and its metabolites [3-tert-butyl-5-
chloro-6-hydroxymethyluracil], [6-chloro-2,3-dihydro-7-hydroxymethyl
3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-one], and [6-chloro-2,3-
dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a) pyrimidin-5-one], calculated
as terbacil, in/on alfalfa, apple, asparagus, blueberry, caneberry,
peach, peppermint, spearmint, strawberry, and sugarcane ranging from
0.1-2.0 ppm. A time-limited tolerance at 0.4 ppm in/on watermelon is
currently established under section 18 exemption of the FIFRA and
scheduled to expire June 30, 2007. Tolerances in/on livestock are not
currently established. There are no feed commodities associated with
watermelon.
    Risk assessments were conducted by EPA to assess dietary exposures
from terbacil in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    An appropriate endpoint attributable to a single dose for the
general population or females 13 years and older was not identified in
the toxicological studies for terbacil; therefore, a quantitative acute
dietary exposure assessment is not needed.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID\TM\ ver. 2.3), which
incorporates food consumption data as reported by respondents in the
U.S. Department of Agriculture (USDA) 1994-1996 and 1998 nationwide
Continuing Surveys of Food Intake by Individuals (CSFII), and
accumulated exposure to the chemical for each commodity. The following
assumptions were made for the chronic exposure assessments: The chronic
dietary analysis incorporated tolerance level residues, 100% crop
treated, and DEEM\TM\ (ver 7.81) default processing factors for all
registered/proposed crops. The chronic analysis also assumed the
Screening Concentration in Ground Water (SCI-GROW) modeled water
estimates for all water sources (direct and indirect). The ground water
estimate was generated using the highest registered/proposed
application rate. Although rotational crop tolerances are not currently
established, the Agency concluded that the dietary analysis should
incorporate residue estimates for rotated crops. Of the registered/
proposed crops, alfalfa, mint, strawberry, sugar cane, and watermelon
are crops which are rotated. Based on the field rotational crop data
(residues <

= 0.19 ppm, 0.3-2.1 x the maximum application rate, 30-day plant-back
intervals (PBIs)), the registered proposed PBIs, and the application
rates, residues in/on crops rotated into alfalfa, mint, and sugar cane
fields which were treated with terbacil are possible. Based on the
field rotational crop data, the dietary analysis assumed a residue of
1.0 ppm for cereal grains and soybean (these crops are commonly rotated
into alfalfa, mint, and sugarcane fields) Based on the tolerances for
the primary crops (0.1-2.0 ppm) and the field rotational crop data, EPA
anticipates that the 1.0 ppm residue for rotated crops is conservative.
    The Agency notes that the assessment assumes, based on cultural
practices, that only cereal grains and soybean are rotated into
alfalfa, sugar cane, and mint fields while the registered application
scenario for these crops permits the rotation of any crop. When the
residue estimates used to generate the dietary exposure estimates are
taken in total ((SCI-GROW) drinking water estimates, tolerance level
residue, 100% crop treated for all registered/proposed crops,
conservative residue estimates for cereal grain and soybean rotation
crops), EPA concludes that chronic dietary exposure to terbacil is
likely to be less than the estimates provided in this document.
    iii. Cancer. Terbacil is classified as not likely to be
carcinogenic to humans based on the lack of evidence of carcinogenicity
in a carcinogenicity study in mice and two combined chronic toxicity/
carcinogenicity studies in rats. Therefore, a cancer exposure
assessment was not performed.
    2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for terbacil in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of terbacil. Further information regarding EPA drinking
water models used in pesticide exposure assessment can be found at
http://www.epa.gov/oppefed1/models/water/index.htm.

    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and SCI-GROW models, the estimated environmental
concentrations (EECs) of terbacil for acute exposures are estimated to
be 123 parts per billion (ppb) for surface water and 111 ppb for ground
water. The EECs for chronic exposures are estimated to be 25.4 ppb for
surface water and 111 ppb for ground water.
    The drinking water estimates are based upon the crop with the
highest application rate (sugarcane). The use of terbacil on sugarcane
has the highest single application rate at 3.0 pounds active
ingredient/acre (lb ai/A), this application rate was used in the PRZM/
EXAMS and SCI-GROW models to estimate the concentrations of this
chemical in surface water and ground water, respectively.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model (DEEM\TM\ - FCID). For chronic
dietary risk assessment, the annual average concentration of 111 ppb
was used to access the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets).
    Terbacil is not registered for use on any sites that would result
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative
risk approach based on a common mechanism of toxicity, EPA has not made
a common mechanism of toxicity finding as to terbacil and any other
substances and terbacil does not appear to produce a toxic metabolite
produced by other substances. For the purposes of this tolerance
action, therefore, EPA has not assumed that terbacil has 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
the policy statements released by EPA's Office of Pesticide Programs
concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply
an additional tenfold 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. Margins of safety are
incorporated into EPA risk assessments either directly through use of a
MOE analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans. In
applying this provision, EPA either retains the default value of 10X
when reliable data do not support the choice of a different factor, or,
if reliable data are available, EPA uses a different additional safety
factor value based on the use of traditional uncertainty factors and/or
special FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no indication of
increased susceptibility of rat and rabbit fetuses to in utero and/or
postnatal exposure to terbacil.
    3. Conclusion. There is a complete toxicity database for terbacil
and exposure data are complete or are estimated based on data that
reasonably account for potential exposures. Based on analyses of
available exposure data, as outlined in Unit III.C.1.ii., the Agency
believes that exposure to terbacil from existing and potential sources
has been adequately assessed and is likely to be less than the
estimates provided. EPA concludes that the FQPA SF can be reduced to 1x
for the following reasons: (i) There is no evidence of increased
susceptibility in rat and rabbit fetuses to in utero exposure to
terbacil; (ii) there is no evidence of increased susceptibility to
terbacil following prenatal exposure in a 3-generation reproduction
study in rats; (iii) there are no residual toxicological uncertainties
or concerns for increased susceptibility; (iv) there are well
established NOAELs and LOAELs in the developmental and reproduction
studies; (v) the environmental fate database is adequate to access the
nature and magnitude of the residue in drinking water; (vi) the dietary
exposure analysis assumed tolerance-level residues and 100% crop
treated.

E. Aggregate Risks and Determination of Safety

    The Agency currently has two ways to estimate total aggregate
exposure to a

pesticide from food, drinking water, and residential uses. First, a
screening assessment can be used, in which the Agency calculates
drinking water levels of comparison (DWLOCs) which are used as a point
of comparison against estimated drinking water concentrations (EDWCs).
The DWLOC values are not regulatory standards for drinking water, but
are theoretical upper limits on a pesticide's concentration in drinking
water in light of total aggregate exposure to a pesticide in food and
residential uses. More information on the use of DWLOCs in dietary
aggregate risk assessments can be found at http://www.epa.gov/oppfead1/trac/science/screeningsop.pdf
.

    More recently the Agency has used another approach to estimate
aggregate exposure through food, residential and drinking water
pathways. In this approach, modeled surface water and ground water
EDWCs are directly incorporated into the dietary exposure analysis,
along with food. This provides a more realistic estimate of exposure
because actual body weights and water consumption from the CSFII are
used. The combined food and water exposures are then added to estimated
exposure from residential sources to calculate aggregate risks. The
resulting exposure and risk estimates are still considered to be high
end, due to the assumptions used in developing drinking water modeling
inputs.
    1.  Acute risk. An endpoint of concern attributable to a single
exposure was not identified in the hazard database and therefore no
acute risk is expected from exposure to terbacil.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to terbacil
from food and water will utilize 40% of the cPAD for the U.S.
population, 99% of the cPAD for all infants < 1 year old (subpopulations
at greatest exposure), and 94% of the cPAD for children 1-2 years old.
There are no residential uses for terbacil that result in chronic
residential exposure to terbacil. Based on the use pattern, chronic
residential exposure to residues of terbacil is not expected since
there are no registered residential use. The Agency believes that
exposure to terbacil from existing and potential sources has been
adequately assessed and that chronic exposure to terbacil is likely to
be less than the estimates provided in this document as discussed in
Unit III.C.1.ii.
    3. Short-term and Intermediate-term risk. Short-term and
intermediate-term aggregate exposure takes into account residential
exposure plus chronic exposure to food and water (considered to be a
background exposure level). Terbacil is not registered for use on any
sites that would result in residential exposure. Therefore, the
aggregate risk is the sum of the risk from food and water, which do not
exceed the Agency's level of concern.
    4. Aggregate cancer risk for U.S. population. Terbacil has been
classified as ``not likely to be carcinogenic to humans'' based on the
results of a carcinogenicity study in mice and the combined chronic
toxicity and carcinogenicity study in rats. Therefore, terbacil is not
expected to pose a cancer risk to humans.
    5. 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, and to infants and children from aggregate
exposure to terbacil residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    There is a practical analytical method gas chromatography/electron
capture detection (GC/ELCD) for detecting and measuring levels of
terbacil in or on food with residues at or above the level set by the
terbacil tolerance(Method II of PAM Vol. II). EPA has provided
information on this method to the Food and Drug Administration (FDA).
The method is available to anyone who is interested and may be
requested from: Chief, Analytical Chemistry Branch, Environmental
Science Center, 701 Mapes Rd. Ft. Meade, MD 20755-5350; telephone
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    There are no Codex, Canadian, or Mexican maximum residue limits in
or on watermelon.

C. Conditions of Registration

    Data gaps exist as follow and are required to be satisfactorily
filled as conditions of registration for this use.
    1. Petition Method Validation (PMV) of the plant method(s).
    2. FDA multiresidue testing of terbacil and its metabolites through
protocol D.
     3. Additional watermelon field trial, conducted with application
after crop emergence, in Region 3 (n=1), 5 (n=1), and 6 (n=1).

V. Conclusion

    Therefore, tolerance is established for combined residues of the
herbicide, terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], calculated as terbacil, in or on watermelon at 1.0
ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of
FFDCA 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 rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this rule is not subject to Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does
not contain any information collections subject to OMB approval under
the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose
any enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law
104-4). 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); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). 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 of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since
tolerances and exemptions that are established on the basis of a
petition under section 408(d) of FFDCA, 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. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10,

1999). Executive Order 13132 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by State and local
officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. For these same reasons, the Agency has
determined that this rule does not have any ``tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 6,
2000). Executive Order 13175, requires EPA to develop an accountable
process to ensure ``meaningful and timely input by tribal officials in
the development of regulatory policies that have tribal implications.''
``Policies that have tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian tribes, on the relationship between the Federal
Government and the Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.''
This rule will not have substantial direct effects on tribal
governments, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this rule.

VII. Congressional Review Act

    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 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 this final rule in the Federal Register. This final
rule 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.

    May 16, 2006.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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. Section 180.209 is revised to read as follows:

Sec.  180.209   Terbacil; tolerances for residues.

    (a) General. Tolerances are established for combined residues of
the herbicide terbacil, (3-tert-butyl-5-chloro-6-methyluracil) and its
metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro-
2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo(3,2-a) pyrimidin-5-
one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo(3,2-a)
pyrimidin-5-one], calculated as terbacil, in or on the following raw
agricultural commodities:

------------------------------------------------------------------------
                      Commodity                        Parts per million
------------------------------------------------------------------------
Alfalfa, forage......................................                1.0
Alfalfa, hay.........................................                2.0
Apple................................................                0.3
Asparagus............................................                0.4
Blueberry............................................                0.2
Canebserry...........................................                0.2
Peach................................................                0.2
Peppermint, tops.....................................                2.0
Spearmint, tops......................................                2.0
Strawberry...........................................                0.1
Sugarcane, cane......................................                0.4
Watermelon...........................................                1.0
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E6-8275 Filed 5-30-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: July 20, 2010 (Volume 75, Number 138)]
[Notices]
[Page 42116]
[DOCID:fr20jy10-75]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1907-DR; Docket ID FEMA-2010-0002]

North Dakota; Amendment No. 3 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of North Dakota (FEMA-1907-DR), dated April 30, 2010, and
related determinations.

DATES: Effective Date: July 13, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery Directorate,
Federal Emergency Management Agency, 500 C Street, SW., Washington, DC
20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of North Dakota is hereby amended to include the
following areas among those areas determined to have been adversely
affected by the event declared a major disaster by the President in his
declaration of April 30, 2010.

    Bottineau, Kidder, McHenry, Renville, and Ward Counties for
Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050 Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-17616 Filed 7-19-10; 8:45 am]
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[Federal Register Volume 85, Number 27 (Monday, February 10, 2020)]
[Notices]
[Page 7548]
[FR Doc No: 2020-02554]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP20-481-000]

BP Energy Company v. Natural Gas Pipeline Company of America LLC;
Notice of Complaint

    Take notice that on January 31, 2020, pursuant to Rule 206 of the
Federal Energy Regulatory Commission's (Commission) Rules of Practice
and Procedure, 18 CFR 385.206 (2019), BP Energy Company, (Complainants)
filed a formal complaint against Natural Gas Pipeline Company of
America LLC, (Respondent) requesting the Commission to direct the
Respondent to follow its presently effective FERC Gas Tariff (Tariff),
Section 4 of the Natural Gas Act (NGA), and the Commission's
regulations thereunder, all as more fully explained in the complaint.
    The Complainant certifies that copies of the complaint were served
on Respondent's corporate representatives designated on the
Commission's Corporate Officials List.
    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. The Respondent's
answer and all interventions, or protests must be filed on or before
the comment date. The Respondent's answer, motions to intervene, and
protests must be served on the Complainants.
    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 5 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 electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
``eSubscription'' link on the website that enables subscribers to
receive email notification when a document is added to a subscribed
docket(s). For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on February 20, 2020.

    Dated: February 4, 2020.
 Nathaniel J. Davis, Sr.,
 Deputy Secretary.
[FR Doc. 2020-02554 Filed 2-7-20; 8:45 am]
BILLING CODE 6717-01-P