[Federal Register: July 20, 2006 (Volume 71, Number 139)]
[Proposed Rules]
[Page 41192-41196]
[DOCID:fr20jy06-20]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[EPA-HQ-OAR-2003-0130; FRL-8200-1]
RIN 2060-AL90

Protection of Stratospheric Ozone: Minor Amendments to the
Regulations Implementing the Allowance System for Controlling HCFC
Production, Import and Export

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing to amend the current regulations governing
the production and trade of certain ozone-depleting substances to
address issues concerning the export of previously imported material,
heels, the exemption allowance petition process for HCFC-141b for
military and space vehicle applications, and the definition for
``importer.'' We are proposing these minor adjustments to our
regulations in response to requests from the regulated community, to
ensure equitable treatment of stakeholders, and to reduce burden where
the integrity of the requirements can still be sufficiently maintained.
These proposed amendments appear in the ``Rules and Regulations''
section of this Federal Register as a direct final rule.

DATES: Comments must be submitted by August 21, 2006, or by September
5, 2006 if a hearing is requested by July 31, 2006. If requested, a
hearing will be held on August 4, 2006 and the comment period will be
extended until September 5, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2003-0130, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Docket , Air and Radiation Docket and
Information Center, U.S. Environmental Protection Agency, Mail Code:
6102T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
     Hand Delivery: Docket EPA-HQ-OAR-2003-0130, Air
and Radiation Docket at EPA West, 1301 Constitution Avenue NW., Room
B108, Mail Code 6102T, Washington, DC 20460. 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-OAR-
2003-0130. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through http://www.regulations.gov or e-mail.

The http://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 http://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.

FOR FURTHER INFORMATION CONTACT: Cindy Axinn Newberg, EPA,
Stratospheric Protection Division, Office of Atmospheric Programs,
Office of Air and Radiation (6205J), 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: (1) Under the Montreal Protocol on
Substances that Deplete the Ozone Layer (Protocol), as amended, the
U.S. and other industrialized countries that are Parties to the
Protocol have agreed to limit production and consumption of
hydrochlorofluorocarbons (HCFCs) and to phase out consumption in a
step-wise fashion over time, culminating in a complete phaseout in
2030. Title VI of the Clean Air Act Amendments of 1990 (CAAA)
authorizes EPA to promulgate regulations to manage the consumption and
production of HCFCs until the total phaseout in 2030. EPA promulgated
final regulations establishing an allowance tracking system for HCFCs
on January 21, 2003 (68 FR 2820). These regulations were amended on
June 17, 2004 (69 FR 34024) to ensure U.S. compliance with the Montreal
Protocol. Today's proposed action would amend aspects of the
regulations that relate to exports of previously imported material, the
import of HCFC heels, the HCFC-

141b exemption allowance petition process, and the definition of
``importer.'' We are proposing these minor adjustments to our
regulations in response to requests from the regulated community, to
ensure equitable treatment of stakeholders, and to reduce burden where
the integrity of the requirements can still be sufficiently maintained.
    In the ``Rules and Regulations'' section of this Federal Register,
we are issuing these amendments as a direct final rule without prior
proposal because we view this as a non-controversial 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,
or particular provisions of the rule, and the rule or the particular
provisions will not take effect. We would address all public comments
in any subsequent final rule based on this proposed rule. We will not
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
direct final action that is located in the ``Rules and Regulations''
section of this Federal Register.
    (2) Tips for Preparing Your Comments. When submitting comments,
remember to:
     Identify the rulemaking by docket number and other
identifying information (subject heading, Federal Register date and
page number).
     Follow directions--The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
     Explain why you agree or disagree; suggest alternatives
and substitute language for your requested changes.
     Describe any assumptions and provide any technical
information and/or data that you used.
     If you estimate potential costs or burdens, explain how
you arrived at your estimate in sufficient detail to allow for it to be
reproduced.
     Provide specific examples to illustrate your concerns, and
suggest alternatives.
     Explain your views as clearly as possible, avoiding the
use of profanity or personal threats.
     Make sure to submit your comments by the comment period
deadline identified.

Table of Contents

I. Regulated Entities
II. Statutory and Executive Order Reviews
    A. Executive Order 12866: Regulatory Planning and Review
    B. Paperwork Reduction Act
    C. Regulatory Flexibility Act Regulatory Flexibility Act (RFA),
as Amended by the Small Business Regulatory Enforcement Fairness Act
of 1996 (SBREFA), 5 U.S.C. 601 et seq.
    D. Unfunded Mandates Reform Act
    E. Executive Order 13132: Federalism
    F. Executive Order 13175: Consultation and Coordination With
Indian Tribal Governments
    G. Executive Order 13045: Protection of Children From
Environmental Health & Safety Risks
    H. Executive Order 13211: Actions That Significantly Affect
Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act

I. Regulated Entities

    These minor amendments to the HCFC allowance allocation system
would affect the following categories:

------------------------------------------------------------------------
                                NAICS                    Examples of
          Category               code     SIC code   regulated entities
------------------------------------------------------------------------
Chlorofluorocarbon gas           325120       2869  Chlorodifluoromethan
 manufacturing.                                      e manufacturers;
                                                     Dichlorofluoroethan
                                                     e manufacturers
                                                     Chlorodifluoroethan
                                                     e manufacturers.
Chlorofluorocarbon gas           325120       2869   Chlorodifluorometha
 importers.                                          ne importers;
                                                     Dichlorofluoroethan
                                                     e importers;
                                                     Chlorodifluoroethan
                                                     e importers.
Chlorofluorocarbon gas           325120       2869  Chlorodifluoromethan
 exporters.                                          e exporters;
                                                     Dichlorofluoroethan
                                                     e exporters;
                                                     Chlorodifluoroethan
                                                     e exporters.
Polystyrene Foam Product         326140       3086  Plastics foam
 Manufacturing.                                      Products
                                                     (Polystyrene Foam
                                                     Products).
Urethane and Other Foam          326150       3086  Insulation and
 Product (Except                                     cushioning, foam
 Polystyrene) Manufacturing.                         plastics (except
                                                     polystyrene)
                                                     manufacturing.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in this table could also be affected. To determine whether
your facility, company, business organization, or other entity is
regulated by this action, you should carefully examine these
regulations. If you have questions regarding the applicability of this
action to a particular entity, consult the person listed in the FOR
FURTHER INFORMATION CONTACT section.

II. Statutory and Executive Order Reviews

A. Executive Order 12866: Regulatory Planning and Review

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the
Agency must determine whether this regulatory action is ``significant''
and therefore subject to OMB review and the requirements of the
Executive Order. The Order defines a ``significant'' regulatory action
as one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more,
or adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal government or communities;
    (2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
    (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
    It has been determined that this proposed rule is not a
``significant regulatory action'' within the meaning of the Executive
Order and is therefore not subject to OMB review.

B. Paperwork Reduction Act

    This action does not impose any new information collection burden.
Instead, this NPRM proposes to decrease the frequency of one specific
report and limit the range of types of containers subject to a specific
regulatory requirement. The Office of Management and Budget (OMB) has
previously approved the information collection requirements contained
in the existing regulations at 40 CFR part 82 subpart A under the
provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and
has assigned OMB control number 2060-0498 (EPA ICR No. 2014.02). A copy
of the OMB approved Information Collection Request (ICR) may be
obtained from the Collection Strategies Division; U.S. Environmental
Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC
20460 or by calling<PHONE_NUMBER>. Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements; train personnel to be able to
respond to a collection of information; search data sources; complete
and review the collection of information; and transmit or otherwise
disclose the information. An agency may not conduct or sponsor, and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number. The OMB control
numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

C. Regulatory Flexibility Act (RFA), as Amended by the Small Business
Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et
seq.

    The Regulatory Flexibility Act (RFA) generally requires an agency
to prepare a regulatory flexibility analysis of any rule subject to
notice and comment rulemaking requirements under the Administrative
Procedure Act or any other statute unless the agency certifies that the
rule will not have a significant economic impact on a substantial
number of small entities. Small entities include small businesses,
small organizations, and small governmental jurisdictions.
    For purposes of assessing the impacts of today's rule on small
entities, small entity is defined as: (1) A small business as defined
by the NAICS codes below (2) a small governmental jurisdiction that is
a government of a city, county, town, school district or special
district with a population of less than 50,000; and (3) a small
organization that is any not-for-profit enterprise which is
independently owned and operated and is not dominant in its field.

----------------------------------------------------------------------------------------------------------------
                                                                                NAICS small
                                                                                business size
                                                                                standard  (in
                            Category                                NAICS code       SIC code        number of
                                                                                employees or
                                                                                millions of
                                                                                dollars)
----------------------------------------------------------------------------------------------------------------
1. Chemical and Allied Products, NEC............................          424690            5169             100
2. Chlorofluorocarbon gas exporters.............................          325120            2869             100
----------------------------------------------------------------------------------------------------------------

    After considering the economic impacts of today's direct final rule
on small entities, I certify that this action will not have a
significant economic impact on a substantial number of small entities.
This direct final rule will not impose any requirements on small
entities. None of the entities affected by this rule are considered
small as defined by the size standards listed above.

D. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public
Law 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local and tribal
government and the private sector. Under section 202 of the UMRA, EPA
generally must prepare a written statement, including a cost-benefit
analysis, for proposed and final rules with ``Federal mandates'' that
may result in expenditures by State, local and tribal governments, in
the aggregate, or by the private sector, of $100 million or more in any
one year. If a written statement is required under section 202, section
205 of the UMRA generally requires EPA to identify and consider a
reasonable number of regulatory alternatives and adopt the least
costly, most cost-effective or least burdensome alternative that
achieves the objectives of the rule, unless the Agency explains why
this alternative is not selected or the selection of this alternative
is inconsistent with law.
    Section 203 of the UMRA requires the Agency to establish a plan for
obtaining input from and informing, educating, and advising any small
governments that may be significantly or uniquely affected by the rule.
Section 204 of the UMRA requires the Agency to develop a process to
allow elected state, local, and tribal government officials to provide
input in the development of any proposal containing a significant
Federal intergovernmental mandate.
    EPA has determined that this proposed rule does not contain a
Federal mandate that may result in expenditures of $100 million or more
by State, local and tribal governments, in the aggregate, or by the
private sector, in any one year. The provisions in this proposed rule
fulfill the obligations of the United States under the international
treaty, The Montreal Protocol on Substances that Deplete the Ozone
Layer, as well as those requirements set forth by Congress in the Clean
Air Act. Viewed as a whole, all of these proposed amendments do not
create a Federal mandate resulting in costs of $100 million or more in
any one year for State, local and tribal governments, in the aggregate,
or for the private sector. Thus, this proposed rule is not subject to
the requirements of sections 202 and 205 of the UMRA. EPA has also
determined that this proposal contains no regulatory requirements that
might significantly or uniquely affect small governments; therefore,
EPA is not required to develop a plan with regard to small governments
under section 203. Finally, because this proposal does not contain a
significant intergovernmental mandate, the Agency is not required to
develop a process to obtain input from elected state, local, and tribal
officials under section 204.

E. Executive Order 13132: Federalism

    Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August
10, 1999), 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.''
    Under Section 6 of Executive Order 13132, EPA may not issue a
regulation that has federalism implications, that imposes substantial
direct compliance costs, and that is not required by statute, unless
the Federal government provides the funds necessary to pay the direct
compliance costs incurred by State and local governments, or EPA
consults with State and local officials early in the process of
developing the regulation. EPA also may not issue a regulation that has
federalism implications and that preempts State law, unless the Agency
consults with State and local officials early in the process of
developing the regulation.
    This proposed rule does not have federalism implications. It will
not have substantial direct effects on the States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various levels of government,
as specified in Executive Order 13132. Today's proposal is expected to
primarily affect producers, importers and exporters of HCFCs. Thus, the
requirements of section 6 of the Executive Order do not apply. In the
spirit of Executive Order 13132, and consistent with EPA policy to
promote communications between EPA and State and local governments, EPA
specifically solicits comment on this proposed rule from State and
local officials.

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

    Executive Order 13175, entitled ``Consultation and Coordination
with Indian Tribal Governments'' (65 FR 67249, November 9, 2000),
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.'' This proposed rule does not
have tribal implications, as specified in Executive Order 13175. This
proposal does not significantly or uniquely affect the communities of
Indian tribal governments. It does not impose any enforceable duties on
communities of Indian tribal governments. Thus, Executive Order 13175
does not apply to this rule.

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

    Executive Order 13045: ``Protection of Children from Environmental
Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997) applies
to any rule that: (1) Is determined to be ``economically significant''
as defined under Executive Order 12866, and (2) concerns an
environmental health or safety risk that EPA has reason to believe may
have a disproportionate effect on children. If the regulatory action
meets both criteria, the Agency must evaluate the environmental health
or safety effects of the planned rule on children, and explain why the
planned regulation is preferable to other potentially effective and
reasonably feasible alternatives considered by the Agency. While this
proposal is not subject to the Executive Order because it is not
economically significant as defined in E.O. 12866, we nonetheless have
reason to believe that the environmental health or safety risk
addressed by this action may have a disproportionate effect on
children. Depletion of stratospheric ozone results in greater
transmission of the sun's ultraviolet (UV) radiation to the earth's
surface. The following studies describe the effects on children of
excessive exposure to UV radiation: (1) Westerdahl J, Olsson H, Ingvar
C. ``At what age do sunburn episodes play a crucial role for the
development of malignant melanoma,'' Eur J Cancer 1994: 30A: 1647-54;
(2) Elwood JM Japson J. ``Melanoma and sun exposure: an overview of
published studies,'' Int J Cancer 1997; 73:198-203; (3) Armstrong BK,
``Melanoma: childhood or lifelong sun exposure,'' In: Grobb JJ, Stern
RS Mackie RM, Weinstock WA, eds. ``Epidemiology, causes and prevention
of skin diseases,'' 1st ed. London, England: Blackwell Science, 1997:
63-6; (4) Whieman D., Green A. ``Melanoma and Sunburn,'' Cancer Causes
Control, 1994: 5:564-72; (5) Heenan, PJ. ``Does intermittent sun
exposure cause basal cell carcinoma? A case control study in Western
Australia,'' Int J Cancer 1995; 60: 489-94; (6) Gallagher, RP, Hill,
GB, Bajdik, CD, et al. ``Sunlight exposure, pigmentary factors, and
risk of nonmelanocytic skin cancer I, Basal cell carcinoma.'' Arch
Dermatol 1995; 131: 157-63; (7) Armstrong, DK. ``How sun exposure
causes skin cancer: an epidemiological perspective,'' Prevention of
Skin Cancer. 2004. 89-116. The public is invited to submit or identify
peer-reviewed studies and data, of which EPA may not be aware, that
assessed results of early life exposure to UV radiation.
    This proposal concerns minor changes to the existing regulatory
regime for the class II controlled substances. Theses minor changes are
not expected to increase the impacts on children's health from
stratospheric ozone depletion.

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

    This proposed rule is not a ``significant energy action'' as
defined in Executive Order 13211, ``Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 28355
(May 22, 2001)) because it is not a significant regulatory action under
Executive Order 12866.

I. The National Technology Transfer and Advancement Act

    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) directs EPA to use voluntary consensus standards in its
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs EPA
to provide Congress, through OMB, explanations when the Agency decides
not to use available and applicable voluntary consensus standards. This
proposed rulemaking does not involve technical standards. Therefore,
EPA is not considering the use of any voluntary consensus standards.

List of Subjects in 40 CFR Part 82

    Environmental protection, Administrative practice and procedure,
Air pollution control, Chemicals, Chlorofluorocarbons, Exports,
Hydrochlorofluorocarbons, Imports, Reporting and recordkeeping
requirements.

    Dated: July 13, 2006.
Stephen L. Johnson,
Administrator.
 [FR Doc. E6-11531 Filed 7-19-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 48 (Wednesday, March 12, 2014)]
[Rules and Regulations]
[Pages 13877-13882]
[FR Doc No: 2014-05399]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0161; FRL-9906-99]

Fenamidone; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenamidone in or on ginseng; bean, succulent, except cowpea; onion,
blub, subgroup 3-07A; and onion, green, subgroup 3-07B. This regulation
additionally removes several individual tolerances that are superseded
by inclusion in crop subgroup tolerances. Interregional

Research Project Number 4 (IR-4) requested these tolerances under the
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 12, 2014. Objections and
requests for hearings must be received on or before May 12, 2014, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2013-0161, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email 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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

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

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2013-0161 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 12, 2014. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2013-0161, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.

Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of June 5, 2013 (78 FR 33785) (FRL-9386-2),
EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C.
346a(d)(3), announcing the filing of a pesticide petition (PP 3E8150)
by IR-4, 500 College Road East, Suite 201 W., Princeton, NJ 08540. The
petition requested that 40 CFR 180.579 be amended by establishing
tolerances for residues of the fungicide fenamidone, 4H-imidazol-4-one,
3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-,(S)-, in
or on ginseng at 0.80 parts per million (ppm); bean, succulent at 0.80
ppm; onion, bulb, subgroup 03-07A at 0.20 ppm; and onion, green,
subgroup 03-07B at 1.5 ppm. The petition additionally requested to
remove the established tolerances in or on garlic at 0.20 ppm; garlic,
great headed at 0.20 ppm; leek at 1.5 ppm; onion, bulb at 0.20 ppm;
onion, green at 1.5 ppm; onion, welsh at 1.5 ppm; shallot, bulb at 0.20
ppm; and shallot, fresh leaves at 1.5 ppm, as they will be superseded
by the tolerances described in this unit. That document referenced a
summary of the petition prepared on behalf of IR-4 by Bayer
CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that cowpea should not be included in the tolerance in or on
bean, succulent. The reason for this change is explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    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. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data

and other relevant information in support of this action. EPA has
sufficient data to assess the hazards of and to make a determination on
aggregate exposure for fenamidone including exposure resulting from the
tolerances established by this action. EPA's assessment of exposures
and risks associated with fenamidone follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
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.
    The target organs in subchronic toxicity studies for fenamidone
were generally the liver; rarely, the thyroid or spleen were also
affected. Target organs for chronic toxicity studies were the liver in
the mouse and dog, and the liver and thyroid in the rat. In the chronic
toxicity rat study, diffuse C-cell hyperplasia of the thyroid in both
sexes was the most sensitive indicator of toxicity, and at higher doses
follicular cells and the liver were also affected. The similarity in
the systemic no-observed-adverse-effect-levels (NOAELs) and the type of
toxicity observed (primarily liver) for the subchronic rat studies with
the parent and plant metabolites (RPA 412636, RPA 412708, and RPA
410193) demonstrated that, on a subchronic basis, plant metabolites
were not more toxic than the parent.
    In the acute neurotoxicity study in rats, clinical signs included
staining of the anogenital region, mucous in the feces, hunched
posture, and unsteady gait. In the subchronic neurotoxicity study in
rats, marginal decreases in brain weights were observed only in high
dose males. Additionally, decreased brain weight occurred in the rat
reproduction study. In a developmental neurotoxicity study in Wistar
rats, no neurobehavioral effects and no neuropathological changes were
observed at any dose in the offspring, but decreased body weight was
observed during pre- and post-weaning.
    In prenatal developmental toxicity studies in rabbits and rats,
there were no developmental effects up to the highest dose tested
(HDT). Maternal toxicity in these studies was observed as increased
liver weights in maternal rabbits and decreased body weight gains and
food consumption in maternal rats. In the reproduction study in rats,
decreased absolute brain weight in F2 female pups occurred at the same
dose levels as decreased absolute brain weight in F1 parental females.
There were no effects on fertility or other measured reproductive
parameters conducted with fenamidone.
    An immunotoxicity study in rats showed a potential
immunosuppression at the HDT; however, the existing risk assessment
points of departure are lower and are therefore protective of this
potential effect. No carcinogenic potential was observed in chronic
studies in rat, mice, and dog; therefore, EPA has determined that
fenamidone is not likely to be a human carcinogen by all relevant
routes of exposure. All mutagenicity studies were negative for both the
parent and plant metabolites, except the parent induced mutant colonies
at the tk locus and increased chromosomal aberrations in human
peripheral blood.
    Specific information on the studies received and the nature of the
adverse effects caused by fenamidone as well as the NOAEL and the
lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies
can be found at http://www.regulations.gov in document: ``Fenamidone:
Human Health Risk Assessment to Support the Section (3) Registration
and the Establishment of Tolerances for Uses on Ginseng, Succulent
Beans (Except Cowpea), Bulb Onion (Subgroup 3-07A), and Green Onion
(Subgroup 3-07B).'' at pp. 30-34 in docket ID number EPA-HQ-OPP-2013-
0161.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL of concern are
identified. Uncertainty/safety factors are used in conjunction with the
POD to calculate a safe exposure level--generally referred to as a
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe
margin of exposure (MOE). For non-threshold risks, the Agency assumes
that any amount of exposure will lead to some degree of risk. Thus, the
Agency estimates risk in terms of the probability of an occurrence of
the adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for fenamidone used for
human risk assessment is discussed in Unit III.B., Table 1 of the final
rule published in the Federal Register of November 16, 2011 (76 FR
70890) (FRL-9325-4).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenamidone, EPA considered exposure under the petitioned-
for tolerances as well as all existing fenamidone tolerances in 40 CFR
180.579. EPA assessed dietary exposures from fenamidone 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. Such effects were identified
for fenamidone. In estimating acute dietary exposure, EPA used Dietary
Exposure Evaluation Model software with the Food Commodity Intake
Database (DEEM-FCID) Version 3.16, which uses food consumption data
from the U.S. Department of Agriculture's (USDA's) National Health and
Nutrition Examination Survey, ``What We Eat in America'' (NHANES/WWEIA)
from 2003 through 2008. As to residue levels in food, EPA used maximum
field trial residues for plant commodities and residues at the limit of
quantitation for livestock commodities, assumed 100 percent crop
treated (PCT) estimates for all commodities, and incorporated
DEEMTM default processing factors, when applicable.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment, EPA used the same dietary risk assessment assumptions as
for the acute dietary risk assessment.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that fenamidone does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use PCT
information in the dietary assessment for fenamidone; 100 PCT were
assumed for all food commodities. However, anticipated residues were
used as maximum field trial residues for plant

commodities and residues at the limit of quantitation for livestock
commodities. Section 408(b)(2)(E) of FFDCA authorizes EPA to use
available data and information on the anticipated residue levels of
pesticide residues in food and the actual levels of pesticide residues
that have been measured in food. If EPA relies on such information, EPA
must require pursuant to FFDCA section 408(f)(1) that data be provided
5 years after the tolerance is established, modified, or left in
effect, demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such data call-ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for fenamidone in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenamidone. 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 PRZM Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of fenamidone for surface water
are expected to be 41.7 parts per billion (ppb) for acute exposures and
11.9 ppb for chronic exposures for non-cancer assessments. For
groundwater, the EDWC of 207 ppb is estimated for all acute and chronic
exposures.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute and chronic dietary
risk assessments, the water concentration value of 207 ppb was used to
assess 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). Fenamidone is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
fenamidone to share a common mechanism of toxicity with any other
substances, and fenamidone does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that fenamidone does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. The pre- and postnatal
toxicity database for fenamidone includes rat and rabbit developmental
toxicity studies, a rat developmental neurotoxicity study (DNT), and a
2-generation reproduction toxicity study in rats. No evidence of
increased quantitative or qualitative susceptibility of rat or rabbit
fetuses to in utero exposure was observed in the developmental toxicity
studies. There was no developmental toxicity in rabbit fetuses up to
100 milligrams/kilograms/day (mg/kg/day), the HDT; maternal toxicity
was exhibited as an increase in absolute liver weight, observed at 30
and 100 mg/kg/day. In the rat developmental study, decreased fetal body
weight and incomplete fetal ossification were observed, but were
considered secondary to maternal toxicity observed as decreased body
weight and food consumption at the limit dose (1,000 mg/kg/day). No
quantitative or qualitative evidence of increased susceptibility was
observed in the 2-generation reproduction study in rats. In that study,
both the parental and offspring LOAELs were based on decreased absolute
brain weight in female F1 adults and female F2 offspring at 89.2 mg/kg/
day. Parental effects consisting of decreased body weight and food
consumption and increased liver and spleen weights were noted at the
same level as decreased pup body weight. There were no reproductive
effects up to the HDT.
    The results of the DNT study indicated an increased susceptibility
of offspring. There was no maternal toxicity at the HDT (429 mg/kg/
day). Effects in the offspring included decreased body weight (9-11%)
and body weight gain (8-20%) during pre-weaning, and decreased body
weight (4-6%) during post-weaning at 429 mg/kg/day (LOAEL). There were
no neurobehavioral effects and no neuropathological changes at any dose
in the offspring.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for fenamidone is complete.
    ii. The concern for the increased susceptibility observed in the
DNT is low because:
    a. There were no neurobehavioral or neuropathological changes in
the offspring at any dose;
    b. A clear NOAEL for the adverse effects in the study was
identified; and
    c. The endpoints used for the various risk assessment scenarios are
much more sensitive than that of the decreased bodyweight of the
offspring.
    Therefore, based on the information above, the available data and
the selection of risk assessment endpoints, EPA has determined that all
endpoints used in the risk assessment for fenamidone are protective of
neurotoxic effects. Accordingly, additional uncertainty factors (UFs)
to account for neurotoxicity are not necessary.
    iii. There is no evidence that fenamidone results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100 PCT, maximum field trial residues for plant commodities, and
residues at the limit of quantitation for livestock commodities. EPA
made conservative

(protective) assumptions in the ground and surface water modeling used
to assess exposure to fenamidone in drinking water. These assessments
will not underestimate the exposures and risks posed by fenamidone.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to fenamidone will occupy 4.8% of the aPAD for children 1-2 years old,
the population group receiving the greatest exposure.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenamidone from food and water will utilize 89% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenamidone.
    3. Short- and intermediate-term risk. Short- and intermediate-term
aggregate exposures take into account short- and intermediate-term
residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Short- and
intermediate-term adverse effects were identified; however, fenamidone
is not registered for any use patterns that would result in short- or
intermediate-term residential exposures. Short- and intermediate-term
risk is assessed based on short- or intermediate-term residential
exposure plus chronic dietary exposure. Because there are no short- or
intermediate-term residential exposures and chronic dietary exposure
has already been assessed under the appropriately protective cPAD
(which is at least as protective as the POD used to assess short-term
risk), no further assessment of short- or intermediate-term risks are
necessary, and EPA relies on the chronic dietary risk assessment for
evaluating short- and intermediate-term risks for fenamidone.
    4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, fenamidone 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 or to infants and children from aggregate
exposure to fenamidone residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, a liquid chromatography with
tandem mass spectrometry detection (LC/MS/MS), is available to enforce
the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for fenamidone.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, EPA has determined that
cowpea should not be included in the bean, succulent tolerance at 0.80
ppm, as was proposed. The bean, succulent definition includes cowpea,
and cowpea has forage and hay associated uses that are considered
significant livestock feedstuffs. Because of the significant livestock
feedstuffs for cowpea, the Agency requires a feeding study in order to
determine the dietary burden associated with cowpea. Because an
appropriate feeding study has not been submitted for fenamidone, cowpea
has been excluded from the tolerance in or on bean, succulent.

V. Conclusion

    Therefore, tolerances are established for residues of fenamidone,
4H-Imidazol-4-one, 3,5-dihydro-5- methyl-2-(methylthio)-5-phenyl-3
(phenylamino)-,(S)-, in or on bean, succulent, except cowpea at 0.80
ppm; ginseng at 0.80 ppm; onion, bulb, subgroup 3-07A at 0.20 ppm; and
onion, green, subgroup 3-07B at 1.5 ppm. This regulation additionally
removes established tolerances at 0.20 ppm in or on garlic; garlic,
great headed; onion, bulb; and shallot, bulb. Finally, this regulation
removes established tolerances at 1.5 ppm in or on leek; onion, green;
onion, welsh; and shallot, fresh leaves.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This 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.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes,

nor does this action alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of FFDCA section 408(n)(4). As such, the Agency has
determined that this action will not have a substantial direct effect
on States or tribal governments, on the relationship between the
national government and the States or tribal governments, or on the
distribution of power and responsibilities among the various levels of
government or between the Federal Government and Indian Tribes. Thus,
the Agency has determined that Executive Order 13132, entitled
``Federalism'' (64 FR 43255, August 10, 1999) and Executive Order
13175, entitled ``Consultation and Coordination with Indian Tribal
Governments'' (65 FR 67249, November 9, 2000) do not apply to this
final rule. In addition, this final rule does not impose any
enforceable duty or contain any unfunded mandate as described under
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C.
1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: February 28, 2014.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    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. In Sec.  180.579:
0
a. Remove the commodities ``Garlic''; ``Garlic, great headed'';
``Leek''; ``Onion, bulb''; ``Onion, green''; ``Onion, welsh'';
``Shallot, bulb''; and ``Shallot, fresh leaves'' from the table in
paragraph (a)(1).
0
b. Add alphabetically the following commodities to the table in
paragraph (a)(1). The amendments read as follows:

Sec.  180.579  Fenamidone; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, succulent, except cowpea............................          0.80

                                * * * * *
Ginseng...................................................          0.80

                                * * * * *
Onion, bulb, subgroup 3-07A...............................          0.20
Onion, green, subgroup 3-07B..............................          1.5

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

* * * * *
[FR Doc. 2014-05399 Filed 3-11-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Notices]
[Page 30927]
[FR Doc No: 2018-14123]

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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: PR18-60-000.
    Applicants: The Narragansett Electric Company.
    Description: Tariff filing per 284.123(b),(e): Revised Statement of
Operating Conditions to be effective 8/1/2018.
    Filed Date: 6/18/18.
    Accession Number:<PHONE_NUMBER>07.
    Comments/Protests Due: 5 p.m. ET 7/9/18.

    Docket Numbers: PR18-61-000.
    Applicants: Columbia Gas of Ohio, Inc.
    Description: Tariff filing per 284.123(b),(e)/: COH Rates effective
5-31-2018.
    Filed Date: 6/21/18.
    Accession Number:<PHONE_NUMBER>79.
    Comments/Protests Due: 5 p.m. ET 7/12/18.

    Docket Numbers: PR18-59-001.
    Applicants: Kinder Morgan Tejas Pipeline LLC.
    Description: Tariff filing per 284.123(b)(2): Errata to Petition of
Approval of Market-Based Rates to be effective 10/1/2018.
    Filed Date: 6/19/18.
    Accession Number:<PHONE_NUMBER>74.
    Comments/Protests Due: 5 p.m. ET 7/10/18.

    Docket Numbers: RP18-789-001.
    Applicants: Cheniere Corpus Christi Pipeline, LP.
    Description: Compliance filing Baseline Compliance Filing RP18-789-
000 to be effective 6/1/2018.
    Filed Date: 6/21/18.
    Accession Number: 20180621-5021.
    Comments Due: 5 p.m. ET 7/3/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    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 date(s). Protests may be considered,
but intervention is necessary to become a party to the proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 25, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-14123 Filed 6-29-18; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 247 (Wednesday, December 26, 2012)]
[Notices]
[Pages 76050-76051]
[FR Doc No: 2012-31043]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Public Workshop on Minimal Residual Disease; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA), in cosponsorship with
the American Society of Clinical Oncology, is announcing a public
workshop that will provide a forum for discussion of extending the
qualification of minimal residual disease (MRD) detection as a
prognostic biomarker to an efficacy/response biomarker in evaluating
new drugs for the treatment of acute myeloid leukemia (AML). Our
objective is for the workshop to provide a venue for an in-depth
discussion of potential endpoints for trials intended to support the
approval of new drugs or biologics for treatment of AML. Participants
in the workshop will examine if any currently used biomarker can be
used as a surrogate endpoint, identify the preferred technology
platform and performance characteristics for the assay of the
biomarker, discuss any issues regarding ongoing deficiencies in
methodological standardization for the biomarker, and determine the
need for additional FDA-approved in-vitro diagnostics for AML drug
development. The primary focus will be on the biomarkers that are or
will soon be ready for incorporation into clinical trials, and the
technical and regulatory challenges for use of these markers.

DATES: The public workshop will be held on March 4, 2013, from 8 a.m.
to 4 p.m.

ADDRESSES: The public workshop will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the
Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the
public workshop participants (non-FDA employees) is through Building 1
where routine security check procedures will be performed. For parking
and security information please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

FOR FURTHER INFORMATION CONTACT: Christine Lincoln, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6413, Silver Spring, MD 20993-0002, 301-
796-2340, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Complete remission, relapse-free survival, and overall survival are
frequently used as endpoints in clinical trials of new therapeutics for
AML. These endpoints have some limitations, especially in the context
of minimal residual disease. Use of morphological complete remission
may miss individuals with clinically significant residual disease who
are not truly in remission. For those being followed after remission
induction, new evidence of submorphological disease may prompt therapy
before morphological relapse. Additionally, for patients with good
prognosis, the length of the clinical trial followup may be very long
when survival is the outcome measured, raising logistical and financial
challenges for study conduct. More information is needed on whether MRD
in AML can be qualified as a response biomarker and then used as a
clinical trial endpoint and what the challenges would be to implement
use of such an endpoint.
    This Public Workshop on Minimal Residual Disease in AML will be one
of a series of FDA workshops to establish processes and procedures
necessary to qualify a prognostic biomarker, MRD, as a possible
response or efficacy biomarker in a group of hematological
malignancies. Evaluation of clinical data suggests that MRD can be
established as a potential surrogate endpoint for pivotal clinical
trials and drug approval given its prominent role as a prognostic
indicator in certain subtypes of acute and chronic leukemia. The Office
of Hematology and Oncology Products has explored, or plans to explore,
the potential utility of MRD as a surrogate endpoint in acute
lymphoblastic leukemia (ALL) (including the relapsed setting), chronic
lymphocytic leukemia (CLL), and AML. Given the diverse pathophysiology
and natural history of these diseases and current practice standards,
individualized consideration of MRD as a surrogate endpoint is
warranted. The ALL workshop was held on April 18, 2012, and the CLL
workshop will be held on February 27, 2013.

II. Structure and Scope of the Workshop

    The workshop's scope will include discussions of the use of flow
cytometry and molecular methods used to detect and measure minimal
residual disease in patients being treated for AML. The workshop will
consist of formal presentations examining the regulatory, scientific,
and clinical basis for use of biomarkers as potential clinical trial
endpoints in AML interspersed with discussions on issues associated
with these endpoints.

III. Attendance and Registration

    FDA encourages patient advocates, representatives from industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop. There is no
registration fee for the public workshop. To register electronically,
please use the following Web site: http://www.zoomerang.com/Survey/WEB22GPAXN9NQB (FDA has verified the Web site address, but we are not
responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register.) Seats are limited and
conference space will be filled in the order in which registrations are
received. Onsite registration will be available to the extent that
space is available on the day of the conference.
    Information regarding special accommodations due to a disability,
visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm. Under the heading
``Resources for You,'' click on ``Public Meetings at the FDA White Oak
Campus.''

    Dated: December 20, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-31043 Filed 12-21-12; 4:15 pm]
BILLING CODE 4160-01-P