[Federal Register Volume 81, Number 201 (Tuesday, October 18, 2016)]
[Proposed Rules]
[Pages 71661-71667]
[FR Doc No: 2016-25162]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-HQ-OAR-2010-0682; FRL-9954-25-OAR]
RIN 2060-AT18

National Emission Standards for Hazardous Air Pollutant
Emissions: Petroleum Refinery Sector

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: On December 1, 2015, the Environmental Protection Agency (EPA)
finalized amendments to the National Emission Standards for Hazardous
Air Pollutants (NESHAP) Refinery Maximum Achievable Control Technology
(MACT) 1 and Refinery MACT 2 regulations and the New Source Performance
Standards (NSPS) for petroleum refineries. Subsequently, the EPA
received three petitions for reconsideration of the final rules. The
EPA is announcing reconsideration and request for public comment on
five issues raised in the petitions for reconsideration where
petitioners claim that the public was not afforded an opportunity to
comment. Additionally, the EPA is proposing amendments to the final
rule to clarify a compliance issue raised by stakeholders subject to
the final rule and to correct a referencing error. The EPA is seeking
comment only on the five identified petition issues and on the proposed
compliance issue clarification and referencing error amendments. The
EPA will not respond to comments addressing any other issues or any
other provisions of the final rule.

DATES: Comments must be received on or before December 2, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2010-0682, at http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be edited or removed from Regulations.gov. The EPA may publish any
comment received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. The EPA
is seeking comment only on the issues specifically identified in this
notice. The EPA will not respond to any comments addressing other
aspects of the final rules or any other related rulemakings. The EPA
will generally not consider comments or comment contents located
outside of the primary submission (i.e. on the web, cloud, or other
file sharing system). For additional submission methods, the full EPA
public comment policy, information about CBI or multimedia submissions,
and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.
    Instructions. Direct your comments to Docket ID No. EPA-HQ-OAR-
2010-0682. The EPA's policy is that all comments received will be
included in the public docket without change, and will be made
available online at http://www.regulations.gov, including any personal
information provided, unless the comment includes information claimed
to be 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 email. Send
or deliver information identified as CBI only to the following address:
OAQPS Document Control Officer (C404-02), Office of Air Quality
Planning and Standards, U.S. EPA, Research Triangle Park, North
Carolina 27711, Attention Docket ID No. EPA-HQ-OAR-2010-0682. Clearly
mark the part or all of the information that you claim to be CBI. For
CBI information on a disk or CD-ROM that you mail to the EPA, mark the
outside of the disk or CD-ROM as CBI and then identify electronically
within the disk or CD-ROM the specific information you claim as CBI. In
addition to one complete version of the comment that includes
information claimed as CBI, you must submit a copy of the comment that
does not contain the information claimed as CBI for inclusion in the
public docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
    The http://www.regulations.gov Web site is an ``anonymous access''
system, which means the EPA will not know your identity or contact
information unless you provide it in the body of your comment. If you
send an email comment directly to the EPA without going through http://www.regulations.gov, your email 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, the 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 the EPA cannot read your comment due to technical
difficulties and cannot contact you for clarification, the EPA may not
be able to consider your comment. Electronic files should not include
special characters or any form of encryption and be free of any defects
or viruses.
    Docket. All documents in the docket are listed in the
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, is not placed on the Internet and will be
publicly available only in hard copy. Publicly available docket
materials are available either electronically in regulations.gov or in
hard copy at the EPA Docket Center, EPA WJC West Building, Room 3334,
1301 Constitution Ave. NW., Washington, DC. 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 EPA Docket Center is
(202) 566-1742. Visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm for additional

information about the EPA's public docket.
    Public hearing. A public hearing will be held if requested by
October 24, 2016 to accept oral comments on this proposed action. The
hearing will be held, if requested, on November 2, 2016 at the EPA's
North Carolina Campus located at 109 T.W. Alexander Drive, Research
Triangle Park, NC 27711. The hearing, if requested, will begin at 9:00
a.m. (local time) and will conclude at 1:00 p.m. (local time). To
request a hearing, to register to speak at a hearing, or to inquire if
a hearing will be held, please contact Ms. Virginia Hunt at (919) 541-
0832 or by email at<EMAIL_ADDRESS>The last day to pre-register
to speak at a hearing, if one is held, will be October 31, 2016.
Additionally, requests to speak will be taken the day of the hearing at
the hearing registration desk, although preferences on speaking times
may not be able to be fulfilled. Please note that registration requests
received before the hearing will be confirmed by the EPA via email.
    Please note that any updates made to any aspect of the hearing,
including whether or not a hearing will be held, will be posted online
at https://www.epa.gov/stationary-sources-air-pollution/petroleum-refinery-sector-risk-and-technology-review-and-new-source. We ask that
you contact Ms. Virginia Hunt at<PHONE_NUMBER> or by email at
<EMAIL_ADDRESS>or monitor our Web site to determine if a hearing
will be held. The EPA does not intend to publish a notice in the
Federal Register announcing any such updates.

FOR FURTHER INFORMATION CONTACT: For questions about this proposed
action, contact Ms. Brenda Shine, Sector Policies and Programs
Division, Refining and Chemicals Group (E143-01), Office of Air Quality
Planning and Standards, U.S. Environmental Protection Agency, Research
Triangle Park, North Carolina, 27711; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; and email address<EMAIL_ADDRESS>
For information about the applicability of the NESHAP to a particular
entity, contact Ms. Maria Malave, Office of Enforcement and Compliance
Assurance, U.S. Environmental Protection Agency, EPA WJC South
Building, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone
number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; and email address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    Preamble Acronyms and Abbreviations. We use multiple acronyms and
terms in this preamble. While this list may not be exhaustive, to ease
the reading of this preamble and for reference purposes, the EPA
defines the following terms and acronyms here:

CAA Clean Air Act
CBI confidential business information
CFR Code of Federal Regulations
DCU delayed coking unit
EPA Environmental Protection Agency
FCCU fluid catalytic cracking unit
HAP hazardous air pollutants
lbs/day pounds per day
LEL lower explosive limit
MACT Maximum Achievable Control Technology
MIR maximum individual risk
MPV miscellaneous process vent
NESHAP National Emissions Standards for Hazardous Air Pollutants
NSPS New Source Performance Standards
NTTAA National Technology Transfer and Advancement Act
OAQPS Office of Air Quality Planning and Standards
OECA Office of Enforcement and Compliance Assurance
OMB Office of Management and Budget
OSHA Occupational Safety and Health Administration
PRA Paperwork Reduction Act
PRD Pressure Relief Devices
psig pounds per square inch gauge
PSM Process Safety Management
PTE potential to emit
RC/CA root cause analysis and corrective action
RFA Regulatory Flexibility Act
RMP Risk Management Plan
RTR residual risk and technology review
SRU sulfur recovery unit
SSM startup, shutdown and malfunction
STP standard temperature and pressure
TTN Technology Transfer Network
UMRA Unfunded Mandates Reform Act
VOC volatile organic compounds
[deg]F degrees Fahrenheit

    Organization of This Document. The information in this preamble is
organized as follows:

I. General Information
    A. What is the source of authority for the reconsideration
action?
    B. Does this action apply to me?
    C. Where can I get a copy of this document and other related
information?
II. Background
III. Reconsideration Issues and Request for Public Comments
    A. Work Practice Standards for PRDs
    B. Work Practice Standards for Emergency Flaring
    C. Assessment of Risk From the Refinery Source Categories After
Implementation of the PRD and Emergency Flaring Work Practice
Standards
    D. Alternative Work Practice Standards for DCUs Employing the
Water Overflow Design
    E. Reduced Frequency of Fenceline Monitoring
IV. Proposed Technical Clarifications
V. Statutory and Executive Order Reviews
    A. Executive Orders 12866: Regulatory Planning and Review and
Executive Order 13563: Improving Regulation and Regulatory Review
    B. Paperwork Reduction Act (PRA)
    C. Regulatory Flexibility Act (RFA)
    D. Unfunded Mandates Reform Act (UMRA)
    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 Risks and Safety Risks
    H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
    I. National Technology Transfer and Advancement Act (NTTAA)
    J. Executive Order 12898: Federal Actions To Address
Environmental Justice in Minority Populations and Low-Income
Populations

I. General Information

A. What is the source of authority for the reconsideration action?

    The statutory authority for this action is provided by sections 112
and 307(d)(7)(B) of the Clean Air Act (CAA)(42 U.S.C. 7412 and
7607(d)(7)(B)).

B. Does this action apply to me?

    Regulated Entities. Categories and entities potentially regulated
by this action are shown in Table 1 of this preamble.

   Table 1--Industrial Source Categories Affected by This Final Action
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                                                              NAICS \a\
                NESHAP and source category                      code
------------------------------------------------------------------------
Petroleum Refining Industry...............................       324110
------------------------------------------------------------------------
\a\ North American Industry Classification System.

    Table 1 of this preamble is not intended to be exhaustive, but
rather to provide a guide for readers regarding entities likely to be
affected by this action for the source categories listed. To determine
whether your facility is affected, you should examine the applicability
criteria in the appropriate NESHAP. If you have any questions regarding
the applicability of any aspect of these NESHAP, please contact the
appropriate person listed in the preceding FOR FURTHER INFORMATION
CONTACT section of this preamble.

C. Where can I get a copy of this document and other related
information?

    In addition to being available in the docket, an electronic copy of
this proposal will also be available on the

Internet through the Technology Transfer Network (TTN) Web site, a
forum for information and technology exchange in various areas of air
pollution control. Following signature by the EPA Administrator, the
EPA will post a copy of this proposed action at: https://www.epa.gov/stationary-sources-air-pollution/petroleum-refinery-sector-risk-and-technology-review-and-new-source. Following publication in the Federal
Register, the EPA will post the Federal Register version and key
technical documents at this Web site.

II. Background

    On June 30, 2014, the EPA published a proposed rule in the Federal
Register addressing the risk and technology review (RTR) for the
Petroleum Refinery NESHAP, 40 CFR part 63, subparts CC (Refinery MACT
1) and UUU (Refinery MACT 2). On December 1, 2015 (80 FR 75178), after
receiving and addressing public comments, the EPA finalized
determinations pursuant to CAA section 112(d)(6) and (f)(2) for the
Petroleum Refinery source categories and amended Refinery MACT 1 and 2
based on those determinations. The final December 2015 action included
a determination that the remaining risk after promulgation of the
revised NESHAP are acceptable and provide an ample margin of safety.
The December 2015 action also finalized changes to Refinery MACT 1 and
2 pursuant to CAA section 112(d)(2) and (3), notably revising the
requirements for flares and pressure relief devices (PRD). The December
2015 action also finalized technical corrections and clarifications to
Refinery NSPS subparts J and Ja to address issues raised by the
American Petroleum Institute (API) in their 2008 petition for
reconsideration of the final NSPS Ja rule that had not been previously
addressed. These include corrections and clarifications to provisions
for sulfur recovery plants, performance testing, and control device
operating parameters.
    Following promulgation, the EPA received three separate petitions
for reconsideration: Two jointly from API and the American Fuel and
Petrochemical Manufacturers (AFPM) and one from Earthjustice (submitted
on behalf of Air Alliance Houston, California Communities Against
Toxics, Clean Air Council, Coalition for a Safe Environment, Del Amo
Action Committee, Environmental Integrity Project, Sierra Club, Texas
Environmental Justice Advocacy Services and Utah Physicians for a
Healthy Environment). The petitions are available for review in the
rulemaking docket (see Docket ID No. EPA-HQ-OAR-2010-0682).
    On January 19, 2016, API and AFPM requested an administrative
reconsideration under section 307(d)(7)(B) of the CAA of certain
provisions of Refinery MACT 1 and 2, as promulgated in the December
2015 final rule. Specifically, API and AFPM requested that the EPA
reconsider the maintenance vent provisions in Refinery MACT 1 for
sources constructed on or before June 30, 2014; the alternate startup,
shutdown, or hot standby standards for fluid catalytic cracking units
(FCCU) constructed on or before June 30, 2014, in Refinery MACT 2; the
alternate startup and shutdown for sulfur recovery units (SRU)
constructed on or before June 30, 2014, in Refinery MACT 2; and the new
catalytic reforming units (CRU) purging limitations in Refinery MACT 2.
The request pertained to providing and/or clarifying the compliance
time for these sources. In response to this request and additional
information received relative to providing additional compliance time
for these provisions, the EPA issued a proposal on February 9, 2016 (81
FR 6814). A final rule was published on July 13, 2016 (81 FR 45232,
July 13, 2016), fully responding to the January 19, 2016, initial
petition for reconsideration submitted by API and AFPM.
    On February 1, 2016, Earthjustice filed a petition for
reconsideration of several aspects of the December 1, 2015, final rule,
and on that same day API and AFPM submitted a supplemental petition for
reconsideration, identifying additional issues on which they sought
reconsideration. In these petitions, both Earthjustice and API/AFPM
requested that the EPA reconsider certain aspects of the December 2015
revisions to Refinery MACT 1 and 2, noting that CAA section
307(d)(7)(B) authorizes the EPA to reconsider a rule where it is
impracticable to raise an objection during the period for public
comment (but within the time specified for judicial review) or if the
grounds for such an objection arose after the close of the public
comment period. In particular, Earthjustice claimed that several
aspects of the revisions to Refinery MACT 1 were not proposed, and,
thus they were precluded from commenting on them during the public
comment period: (1) Work practice standards for PRDs and flares; (2)
alternative water overflow provisions for delayed coking units (DCU);
(3) reduced monitoring provisions for fenceline monitoring; and (4)
adjustments to the risk assessment to account for these new work
practice standards. The API/AFPM petition outlined a number of specific
issues related to the work practice standards for PRDs and flares, and
the alternative water overflow provisions for DCUs, as well as a number
of other specific issues on other aspects of the rule. On June 16,
2016, the EPA granted the petitions for reconsideration from
Earthjustice and API/AFPM on the petitioners' claims as they relate to
the following aspects of the December 2015 revisions to the final rule
to provide an opportunity for public notice and comment: (1) The work
practice standards for PRDs; (2) the work practice standards for
emergency flaring events; (3) the assessment of risk as modified based
on implementation of these PRD and emergency flaring work practice
standards; (4) the alternative work practice standards for DCUs
employing the water overflow design; and (5) the provision allowing
refineries to reduce the frequency of fenceline monitoring at sampling
stations that consistently record benzene concentrations below 0.9
micrograms per cubic meter.

III. Reconsideration Issues and Request for Public Comment

    After reviewing the two February 1, 2016, petitions for
reconsideration as described above, we granted reconsideration to
provide the public an opportunity to comment on selected provisions of
the December 2015 amendments and the assessment of risk as modified to
account for the implementation of the PRD and emergency flaring work
practice standards included in the December 2015 final rule. To ensure
public participation in its final decisions, the Agency is requesting
public comment on these issues as described below. The EPA is seeking
comment only on these five specific issues. The EPA will not respond to
any comments addressing any other provisions of the December 1, 2015,
final Refinery Sector Rule or any other rule or issues.

A. Work Practice Standard for PRDs

    In the proposed rule (79 FR 36970, June 30, 2014), EPA proposed to
revise Refinery MACT 1 to establish operating and pressure release
requirements that apply to all PRDs and to prohibit atmospheric
releases of hazardous air pollutants (HAP) from PRDs. To ensure
compliance, we proposed to require that sources monitor PRDs using a
system that is capable of recording the time and duration of each
pressure release and notifying operators that a pressure release has
occurred. Many commenters suggested that a prohibition on atmospheric
PRD releases was not

indicative of the best performing facilities, was unachievable and/or
very costly, and would have negative environmental impacts due to
additional flares that would need to be installed and operated in
standby mode to accept the PRD releases. Some commenters suggested that
we should instead consider the rules on PRDs that apply to refineries
in the South Coast Air Quality Management District (SCAQMD) and the Bay
Area Air Quality Management District (BAAQMD).
    Based on these comments, we evaluated the two California district
rules and determined that 8 percent (or 12 refineries) are subject to
these requirements, which was a sufficient number of subject refineries
to establish work practice standards that represent the emissions
limitation achieved in practice by the best performers. The two rules
are similar in that they both establish comprehensive regulatory
programs to address the group or system of PRDs at refineries by
requiring monitoring, root cause analysis, and corrective action, and
by focusing on PRDs with the greatest emissions potential through a
combination of applicability thresholds (albeit with differing
thresholds between the two rules). In addition, both rules exclude
emissions from certain types of PRDs--typically lower-release potential
PRDs, liquid-type PRDs, or in the case of SCAAMD PRDs resulting from
events outside of the refinery's control. We considered the two rules
as the basis for determining the best performers for establishing the
work practice standard that is included in the December 2015 final
Refinery Sector Rule (see 40 CFR 63.648(j)(3)). In doing so, similar to
these two rules, we established a work practice standard that is a
comprehensive set of requirements that apply to the group of PRDs at
refineries, and that focuses on reducing the size and frequency of
atmospheric releases of HAP from PRDs, with an emphasis on prevention,
monitoring, correction, and limitations on the frequency of release
events. For further details on our analysis of the SCAQMD and BAAQMD
rules and our use of those rules to establish a comprehensive work
practice standard for PRDs that are representative of the best
performing refineries, refer to the December 1, 2015, notice at 80 FR
75216 and the memorandum in the docket titled, ``Pressure Relief Device
Control Option Impacts for Final Refinery Sector Rule, July 30, 2015
(Docket ID No. EPA-HQ-OAR-2010-0682-0750).
    In the final rule, we established a four-part work practice
standard in place of the prohibition on release to the atmosphere based
on what was achieved by the best performers, as represented by the two
California rules. Consistent with the proposed rule, the first
component of the work practice standard requires that owners or
operators monitor PRDs using a system that is capable of recording the
time and duration of each pressure release and notifying operators that
a pressure release has occurred. Second, the work practice standard
requires refinery owners or operators to establish preventative
measures for each affected PRD to prevent direct release of HAP to the
atmosphere as a result of pressure release events. Third, in the event
of an atmospheric release, the work practice standard requires refinery
owners or operators to conduct a root cause analysis to determine the
cause of a PRD release event. If the root cause was due to operator
error or negligence, then the release would be a violation of the work
practice standard. A second release due to the same root cause for the
same equipment in a 3-year period would be a violation of the work
practice standard. A third release in a 3-year period would be a
violation of the work practice standard, regardless of the root cause.
Force majeure events, as defined in the final rule, would not count in
determining whether there has been a second or third event. The fourth
component of the work practice standard is a requirement for corrective
action. For any event other than a force majeure event, the owner or
operator would be required to conduct a corrective action analysis and
implement the results of the corrective action analysis. Refiners have
45 days to complete the root cause analysis and implement corrective
action after the release event. The results of the root cause analysis
and corrective action are due with the periodic reports on a semi-
annual basis.
    We excluded the following PRDs that have very low potential to emit
(PTE) based on their type of service, size and pressure from the work
practice standard: PRDs that only release material that is liquid at
standard temperature and pressure (STP) and that are hard-piped to a
controlled drain system, PRDs that do not have a PTE of 72 pounds per
day (lbs/day) or more of volatile organic compounds (VOC), PRDs with
design release pressure of less than 2.5 pounds per square inch gauge
(psig), PRDs on mobile equipment, PRDs in heavy liquid service, and
PRDs that are designed solely to release due to liquid thermal
expansion. Although these PRDs are excluded from the work practice
standard, they are subject to the operating and pressure relief
requirements in 40 CFR 63.648(j)(1) and (2), which apply to all PRDs.
    We request public comments on the work practice standard for PRDs
as provided in 40 CFR 63.648(j)(3) and (5) through (7), including the
number and type of release/event allowances; the type of PRDs covered
by the work practice standard; and the definition of ``force majeure
event'' in 40 CFR 63.641. We also request public comments on the
recordkeeping and reporting requirements associated with the work
practice standard in 40 CFR 63.655(g)(10)(iii) and (i)(11).

B. Work Practice Standard for Emergency Flaring

    In the June 2014 proposed rule, the EPA proposed to amend the
operating and monitoring requirements for petroleum refinery flares. As
discussed in the proposal at 79 FR 36904, we determined that the
requirements for flares in the General Provisions at 40 CFR 63.18 were
not adequate to ensure compliance with the Refinery MACT standards. In
general, flares used as air pollution control devices are expected to
achieve a 98-percent HAP destruction efficiency. However, because flows
of waste gases to the flares had diminished based on reductions
achieved by the increased use of flare gas recovery systems, there were
times when the waste gas to the flare contained insufficient heat
content to adequately combust and, thus, a 98-percent HAP destruction
efficiency was not being achieved. In addition, the practice of
applying assist media to the flare (particularly steam to prevent
smoking of the flare tip) had led to a decrease in the combustion
efficiency of flares.
    To ensure that a 98-percent HAP destruction efficiency was being
met, as contemplated at the time the MACT standard was promulgated, we
proposed revisions to Refinery MACT 1 that required flares to operate
with a continuously-lit pilot flame at all times when gases are sent to
the flare, with no visible emissions except for periods not to exceed 5
minutes during any 2 consecutive hours, and to meet flare tip velocity
limits and combustion zone operating limits at all times when gases are
flared.
    During the comment period on the proposed rule, we received
comments that the concern over insufficient heat content of the waste
gas or over-assisting are less problematic in attaining a high level of
destruction efficiency at the flare in emergency situations, where the
flow in the flare

exceeds the smokeless capacity of the flare. Thus, commenters suggested
that better combustion was assured closer to the incipient smoke point
of the flare and that flow velocity limits and limits on visible
emissions should not apply during flaring events.
    In the final rule, we determined that it was appropriate to set
different standards for when a flare is operating below its smokeless
capacity and when it is operating above its smokeless capacity. We
finalized the proposed requirements (with minor revisions) to apply
when a flare is operating below its smokeless capacity.
    We established a separate work practice standard that applies when
a flare exceeds its smokeless capacity. As with flares operating below
the smokeless capacity, the work practice standard requires the
refinery to have a continuously-lit pilot flame and meet combustion
zone operating limits (e.g., heat content in the combustion zone) at
all times and meet the monitoring, recordkeeping, and reporting
requirements. These requirements are the most critical in ensuring that
a 98-percent destruction efficiency is being met. The work practice
standard also requires owners or operators to develop flare management
plans to identify the flare system smokeless capacity and flare
components, waste gas streams that are flared, monitoring systems and
their locations, procedures that will be followed to limit discharges
to the flare that cause the flare to exceed its smokeless capacity, and
prevention measures implemented for PRDs that discharge to the flare
header. The work practice standard requires refinery owners or
operators to conduct a specific root cause analysis and take corrective
action for any flaring event that exceeds the flare's smokeless
capacity and that also exceeds the flare tip velocity and/or visible
emissions limit. Refiners have 45 days to complete the root cause
analysis and implement corrective action after an event. The results of
the root cause and corrective action are due with the periodic reports
on a semi-annual basis.
    If the root cause analysis indicates that the exceedance of the
flare tip velocity and/or the visible emissions limit is caused by
operator error or poor maintenance, the exceedance is a violation of
the work practice standard. A second event causing an exceedance of
either the flare tip velocity or the visible emissions limit within a
rolling 3-year period from the same root cause on the same equipment is
a violation of the standard. A third exceedance of the velocity or
visible emissions limit occurring from the same flare in a rolling 3-
year period is a violation of the work practice standard, regardless of
the cause. However, force majeure events are excluded from the event
count. The requirements for a continuously-lit pilot flame, combustion-
zone operating limits and the monitoring, recordkeeping and reporting
requirements apply at all times (whether the flare is operating below,
at, or above its smokeless capacity), including during a force majeure
event.
    In reviewing the regulatory text for this proposed action, we
determined that 40 CFR 63.670(o)(1)(ii)(B) contains an incorrect
reference to pressure relief devices for which preventative measures
must be implemented. The correct reference is paragraph 40 CFR
63.648(j)(3)(ii) not 40 CFR 63.648(j)(5). We are proposing to correct
this referencing error.
    We request public comments on the above smokeless capacity work
practice standard in 40 CFR 63.670(o), including the requirements to
maintain records of prevention measures in 40 CFR 63.670(o)(1)(ii)(B)
and (o)(1)(vi); the requirement to establish a single smokeless design
capacity in 40 CFR 63.670(o)(1)(iii)(B); the number and type of
releases/events that constitute a violation; the phrase ``. . . and the
flare vent gas flow rate is less than the smokeless design capacity of
the flare'' in 40 CFR 63.670(c) and (d)''; the proposed correction to
paragraph 40 CFR 63.670(o)(1)(ii)(B); and other provisions in 40 CFR
63.670(o)(3) through (7). We also request public comments on the
recordkeeping and reporting requirements associated with these work
practice standards in 40 CFR 63.655(g)(11)(iv) and (i)(9)(x) through
(xii).

C. Assessment of Risk From the Refinery Source Categories After
Implementation of the PRD and Emergency Flaring Work Practice Standards

    The results of our residual risk review for the Petroleum Refinery
source categories were published in the June 30, 2014, proposal (79 FR
36934 through 36942), and included assessment of chronic and acute
inhalation risk, as well as multipathway and environmental risk, to
inform our decisions regarding acceptability and ample margin of
safety. The results indicated that the cancer risk to the individual
most exposed (maximum individual risk or ``MIR'') based on allowable
HAP emissions is no greater than approximately 100-in-1 million, which
is the presumptive limit of acceptability, and that the MIR based on
actual HAP emissions is no greater than approximately 60-in-1 million
but may be closer to 40-in-1 million. In addition, the maximum chronic
non-cancer target organ-specific hazard index (TOSHI) due to inhalation
exposures was less than 1. The evaluation of acute non-cancer risks,
which was conservative, showed acute risks below a level of concern.
Based on the results of a refined site-specific multipathway analysis
portion of the risk review, we also concluded that the cancer risk to
the individual most exposed through ingestion is considerably less than
100-in-1 million.
    In the final Refinery MACT 1 rule, we established work practice
standards for PRD releases and emergency flaring events, which under
the proposed rule would not have been allowed. Thus, because we did not
consider such non-routine emissions under our risk assessment for the
proposed rule, we performed a screening assessment of risk associated
with these emissions for the final rule as discussed in detail in
``Final Residual Risk Assessment for the Petroleum Refining Source
Sector'' in Docket ID No. EPA-HQ-OAR-2010-0682. Our analysis showed
that these HAP emissions could increase the MIR based on actual
emissions by as much as 2-in-1 million, which results in essentially
the same level of risk as was estimated at proposal. We also estimated
that chronic non-cancer TOSHIs attributable to the additional exposures
from non-routine flaring and PRD HAP emissions are well below 1. When
adding the additional chronic noncancer TOSHI risks from the screening
analysis with the analysis in the proposal, chronic noncancer TOSHI
risks still remain below 1. Further, our screening analysis also
projected that maximum acute exposure to non-routine PRD and flare
emissions would result in a maximum hazard quotient (HQ) of 14 from
benzene emissions based on a reference exposure level (REL). Based on
risk analysis performed for the proposed rule and the screening
assessment to consider how conclusions from that analysis would be
affected by the additional non-routine flare and PRD emissions allowed
under the final rule, we determined that the risk posed after
implementation of the revisions to the MACT standards is acceptable.
    We request public comments on the screening analysis and the
conclusions reached based on that analysis in conjunction with the risk
analysis performed for the proposed rule.

D. Alternative Work Practice Standards for DCUs Employing the Water
Overflow Design

    In Refinery MACT 1, we finalized MACT standards for DCU decoking

operations. Existing DCU-affected sources must comply with a 2 psig or
220 degrees Fahrenheit ([deg]F) limit in the drum overhead line
determined on a rolling 60-event basis prior to venting to the
atmosphere, draining, or deheading the coke drum. New DCU affected
sources must comply with a 2.0 psig or 218[emsp14][deg]F limit in the
drum overhead line on a per-event, not-to-exceed basis. In the final
rule, we also finalized an alternative requirement to address DCU with
water overflow design that we did not propose, where pressure
monitoring would not be appropriate. As part of these provisions, we
also included a new requirement in the final rule for DCU with water
overflow design to hard-pipe the overflow drain water to the receiving
tank via a submerged fill pipe (pipe below the existing liquid level)
whenever the overflow water exceeds 220[emsp14][deg]F.
    We request public comments on the alternative work practice
standard for delayed coking units employing a water overflow design
provided in 40 CFR 63.657(e).

E. Reduced Frequency of Fenceline Monitoring

    In the December 2015 final rule, we revised Refinery MACT 1 to
establish a work practice standard requiring refinery owners to monitor
benzene concentrations around the fenceline or perimeter of the
refinery. We promulgated new EPA Methods 325A and B which specify
monitor siting and quantitative sample analysis procedures. The work
practice is designed to improve the management of fugitive emissions at
petroleum refineries through the use of passive monitors by requiring
sources to implement corrective measures if the benzene concentration
in air attributable to emissions from the refinery exceeds a fenceline
benzene concentration action level. The work practice requires refinery
owners to reduce fenceline levels that exceed the concentration action
level to at or below that level. In the final rule, we included
provisions that were not proposed that would allow for reduced
monitoring frequency (after 2 years of continual monitoring) at
monitoring locations with consistently low fenceline concentrations.
    We request public comments on the provision allowing refineries to
reduce the frequency of fenceline monitoring at monitoring sites that
consistently record benzene concentrations below 0.9 micrograms per
cubic meter, as provided in 40 CFR 63.658(e)(3).

IV. Proposed Technical Clarifications

    In this action, the EPA is proposing to amend provisions related to
how to address overlapping requirements for equipment leaks that are
contained in Refinery MACT 1 and in the Refinery Equipment Leak NSPS
(40 CFR part 60, subpart GGGa). The Refinery MACT 1 provision at 40 CFR
63.640(p)(2) currently states that equipment leaks that are subject to
the provisions in the Refinery Equipment Leak NSPS (40 CFR part 60
subpart GGGa) are only required to comply with the provisions in the
Refinery Equipment Leak NSPS. However, the Refinery Equipment Leak NSPS
does not include the new work practice standards finalized in the final
Refinery MACT 1 at 40 CFR 63.648(j) which apply to releases from PRD.
Certain provisions of 40 CFR 63.648(j) detail a work practice standard
for the management of releases from PRD. We intended that these new
work practice standards would be applicable to all PRD at refineries,
including those PRD subject to the requirements in the Refinery
Equipment Leaks NSPS. In order to provide clarity and assure that
stakeholders subject to these provisions fully understand their
compliance obligations, we are proposing that equipment components that
are also subject to the provisions of the Refinery Equipment Leak NSPS,
are required to comply with the provisions specified in the Refinery
Equipment Leaks NSPS, except for PRDs in organic HAP service, which
must only comply with the requirements in Refinery MACT 1 at 40 CFR
63.648(j) for PRDs. We are also amending the introductory text in 40
CFR 63.648(j) to reference Refinery Equipment Leaks NSPS at 40 CFR
60.482-4a and amending paragraphs (j)(2)(i) through (iii) of Refinery
MACT 1 to correct the existing reference to 40 CFR 60.485(b), which
should refer to 40 CFR 60.485(c) and 40 CFR 60.485a(c).

V. Statutory and Executive Order Reviews

    Additional information about these statues and Executive Orders can
be found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders.

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

    This action is not a significant regulatory action and was,
therefore, not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose any new information collection burden
under the PRA. OMB has previously approved the information collection
activities contained in the existing regulations at 40 CFR part 63,
subpart CC and has assigned OMB control number 2060-0340. The proposed
amendments are the result of a clarification that does not affect the
estimated burden of the existing rule. Specifically, we are proposing
amendments clarifying that facilities using the equipment leak overlap
provisions must also comply with the PRD work practice standard in 40
CFR part 63, subpart CC. In our burden estimates for the December 1,
2015, final rule, we assumed that all major source refineries would
have to comply with the PRD work practice standards. Consequently, the
burden estimates provided with the December 1, 2015, final rule are
consistent with the proposed clarifying amendment. Therefore, we have
not revised the information collection request for the existing rule.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, the impact of concern is any significant
adverse economic impact on small entities. An agency may certify that a
rule will not have a significant economic impact on a substantial
number of small entities if the rule relieves regulatory burden, has no
net burden, or otherwise has a positive economic effect on the small
entities subject to the rule. The proposed rule consists of a
clarification which does not change the expected economic impact
analysis performed for the existing rule. We have, therefore, concluded
that this action will have no net regulatory burden for all directly
regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C. 1531-1538, and does not
significantly or uniquely affect small governments. The action imposes
no enforceable duty on any state, local, or tribal governments or the
private sector.

E. Executive Order 13132: Federalism

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

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

    This action does not have tribal implications as specified in
Executive Order 13175. It will not have substantial direct effect 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 action.

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

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because the EPA does not believe the environmental health or safety
risks addressed by this action present a disproportionate risk to
children. This action requests comment on a risk assessment that is
described in section III. C. of this preamble.

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

    This rulemaking does not involve technical standards.

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

    The EPA believes that this action does not have disproportionately
high and adverse human health or environmental effects on minority
populations, low-income populations, and/or indigenous peoples, as
specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The
proposed amendments serve to clarify one aspect of the rule. They do
not relax the control measures on regulated sources, and, therefore, do
not change the level of environmental protection.

List of Subjects in 40 CFR Part 63

    Environmental protection, Administrative practice and procedures,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: October 6, 2016.
Gina McCarthy,
Administrator.
    For the reasons stated in the preamble, title 40, chapter I, of the
Code of Federal Regulations is proposed to be amended as follows:

PART 63--NATIONAL EMISSION STANDARDS FOR HAZARDOUS AIR POLLUTANTS
FOR SOURCE CATEGORIES

0
1. The authority citation for part 63 continues to read as follows:

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

Subpart CC--National Emission Standards for Hazardous Air
Pollutants From Petroleum Refineries

0
2. Section 63.640 is amended by revising paragraph (p)(2) to read as
follows:

Sec.  63.640  Applicability and designation of affected source.

* * * * *
    (p) * * *
    (2) Equipment leaks that are also subject to the provisions of 40
CFR part 60, subpart GGGa, are required to comply only with the
provisions specified in 40 CFR part 60, subpart GGGa, except that
pressure relief devices in organic HAP service must only comply with
the requirements in Sec.  63.648(j).
* * * * *
0
3. Section 63.648 is amended by revising paragraphs (j) introductory
text and (j)(2)(i) through (iii) to read as follows:

Sec.  63.648  Equipment leak standards.

* * * * *
    (j) Except as specified in paragraph (j)(4) of this section, the
owner or operator must comply with the requirements specified in
paragraphs (j)(1) and (2) of this section for pressure relief devices,
such as relief valves or rupture disks, in organic HAP gas or vapor
service instead of the pressure relief device requirements of Sec.
60.482-4 of this chapter, Sec.  60.482-4a of this chapter, or Sec.
63.165, as applicable. Except as specified in paragraphs (j)(4) and (5)
of this section, the owner or operator must also comply with the
requirements specified in paragraph (j)(3) of this section for all
pressure relief devices.
* * * * *
    (2) * * *
    (i) If the pressure relief device does not consist of or include a
rupture disk, conduct instrument monitoring, as specified in Sec.
60.485(c) of this chapter, Sec.  60.485a(c) of this chapter, or Sec.
63.180(c), as applicable, no later than 5 calendar days after the
pressure relief device returns to organic HAP gas or vapor service
following a pressure release to verify that the pressure relief device
is operating with an instrument reading of less than 500 ppm.
    (ii) If the pressure relief device includes a rupture disk, either
comply with the requirements in paragraph (j)(2)(i) of this section
(not replacing the rupture disk) or install a replacement disk as soon
as practicable after a pressure release, but no later than 5 calendar
days after the pressure release. The owner or operator must conduct
instrument monitoring, as specified in Sec.  60.485(c) of this chapter,
Sec.  60.485a(c) of this chapter, or Sec.  63.180(c), as applicable, no
later than 5 calendar days after the pressure relief device returns to
organic HAP gas or vapor service following a pressure release to verify
that the pressure relief device is operating with an instrument reading
of less than 500 ppm.
    (iii) If the pressure relief device consists only of a rupture
disk, install a replacement disk as soon as practicable after a
pressure release, but no later than 5 calendar days after the pressure
release. The owner or operator may not initiate startup of the
equipment served by the rupture disk until the rupture disc is
replaced. The owner or operator must conduct instrument monitoring, as
specified in Sec.  60.485(c) of this chapter, Sec.  60.485a(c) of this
chapter, or Sec.  63.180(c), as applicable, no later than 5 calendar
days after the pressure relief device returns to organic HAP gas or
vapor service following a pressure release to verify that the pressure
relief device is operating with an instrument reading of less than 500
ppm.
* * * * *
0
4. Section 63.670 is amended by revising paragraph (o)(1)(ii)(B) to
read as follows:

Sec.  63.670  Requirements for flare control devices.

* * * * *
    (o) * * *
    (1) * * *
    (ii) * * *
    (B) Implementation of prevention measures listed for pressure
relief devices in Sec.  63.648(j)(3)(ii) for each pressure relief valve
that can discharge to the flare.
* * * * *
[FR Doc. 2016-25162 Filed 10-17-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 25, 2007 (Volume 72, Number 142)]
[Notices]
[Page 40853-40854]
[DOCID:fr25jy07-61]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2007-0612; FRL-8141-9]

Pesticide Program Dialogue Committee; Request for Nominations

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  EPA's Office of Pesticide Programs is inviting nominations of
qualified candidates to be considered for appointment to the Pesticide
Program Dialogue Committee (PPDC).

EPA's current Charter for the PPDC will expire in November 2007. EPA
intends to seek renewal of the PPDC Charter for another 2-year term,
November 2007 to November 2009, in accordance with the Federal Advisory
Committee Act.

DATES: Nominations must be e-mailed or postmarked no later than August
17, 2007.

ADDRESSES:  Nominations should be e-mailed or submitted in writing to
Margie Fehrenbach at the address listed under FOR FURTHER INFORMATION
CONTACT.

FOR FURTHER INFORMATION CONTACT: Margie Fehrenbach, Office of Pesticide
Programs (7501P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders, and especially to persons who
work in agricultural settings or urban settings and who are concerned
about implementation of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA); the Federal Food, Drug, and Cosmetic Act
(FFDCA); and the amendments to both of these major pesticide laws by
the Food Quality Protection Act (FQPA) of 1996. Potentially interested
entities may include but are not limited to: Environmental, consumer
and farmworker groups; agricultural workers and farmers; pesticide
industry and trade associations; pesticide users and growers, pest
consultants, public health organizations; food processors; State, local
and Tribal governments; academia; and the public. Since others also may
be interested, the Agency has not attempted to describe all the
specific entities that may be affected by this action. If you have any
questions regarding the applicability of this action to a particular
entity, consult the persons listed under FOR FURTHER INFORMATION
CONTACT.

B. How Can I Get Copies of this Document and Other Related Information?

    1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPP-2007-0612. Publicly
accessible docket materials are available either in the electronic
docket at http://www.regulations.gov, or, available in hard copy, at

the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm.
S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive
Arlington, VA. The hours of operation of this Docket Facility are from
8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays.
The Docket telephone number is<PHONE_NUMBER>.
    2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr.

II. Background

    The Office of Pesticide Programs is entrusted with the
responsibility to help ensure the safety of the American food supply,
protection and education of those who apply or are exposed to
pesticides occupationally or through use of products, and the general
protection of the environment and special ecosystems from potential
risks posed by pesticides.
    PPDC was established under the Federal Advisory Committee Act
(FACA), Public Law 92-463, in September 1995 for a 2-year term and has
been renewed every 2 years since that time. PPDC provides advice and
recommendations to OPP on a broad range of pesticide regulatory,
policy, and program implementation issues that are associated with
evaluating and reducing risks from use of pesticides.
    EPA is seeking to renew the current PPDC Charter, which expires in
November 2007, for another 2-year term. EPA intends to appoint members
to 2-year terms. An important consideration in EPA's selection of
members will be to maintain balance and diversity of experience and
expertise. EPA also intends to seek broad geographic representation
from the following sectors: Pesticide industry and trade associations;
environmental/public interest and consumer groups; farm worker
organizations; pesticide user, grower, and commodity groups; Federal/
State/local and Tribal governments; academia; and public health
organizations; individuals who work on urban pest management issues;
and the general public.
    Copies of the PPDC charter are filed with appropriate committees of
Congress, the Library of Congress, and are available upon request.

List of Subjects

    Environmental protection, Pesticides and pests.

    Dated: July 13, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
[FR Doc. E7-14332 Filed 7-24-07; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 87, Number 89 (Monday, May 9, 2022)]
[Rules and Regulations]
[Page 27530]
[FR Doc No: 2022-09991]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 214

Railroad Workplace Safety

CFR Correction

    This rule is being published by the Office of the Federal Register
to correct an editorial or technical error that appeared in the most
recent annual revision of the Code of Federal Regulations.
    In Title 49 of the Code of Federal Regulations, parts 200 to 299,
revised as of October 1, 2021, make the following corrections:

0
1. Amend Sec.  214.115 by revising paragraph (b) to read as follows:

Sec.  214.115  Foot protection.

* * * * *
    (b) Foot protection equipment required by this section shall
conform to the requirements of 29 CFR 1910.136(b), as established by
the U.S. Department of Labor, Occupational Safety and Health
Administration.

0
2. Amend Sec.  214.117 by revising paragraph (b) to read as follows:

Sec.  214.117  Eye and face protection.

* * * * *
    (b) Eye and face protection equipment required by this section
shall conform to the requirements of 29 CFR 1910.133(b), as established
by the U.S. Department of Labor, Occupational Safety and Health
Administration.
* * * * *
[FR Doc. 2022-09991 Filed 5-6-22; 8:45 am]
BILLING CODE 0099-10-P


[Federal Register: March 1, 2010 (Volume 75, Number 39)]
[Notices]
[Page 9201-9202]
[DOCID:fr01mr10-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 606-027-CA]

Kilarc-Cow Creek Hydroelectric Project; Notice of Intention To
Prepare an Environmental Impact Statement

February 19, 2010.
    The Federal Energy Regulatory Commission (FERC) has received an
application for surrender of license for the Kilarc-Cow Creek
Hydroelectric Project, FERC No. 606. The project contains two
developments and is located on Old Cow Creek and South Cow Creek in
Shasta County, northern California.
    In the March 13, 2009 application, Pacific Gas and Electric Company
(licensee) proposes to surrender the license, decommission and remove
project facilities, as described in its proposed decommissioning plan.
In general, (1) diversion dams would be removed to stop water
diversions and to allow for free passage of fish and sediment; (2) some
diversion dam abutments and foundations would be left in place to
protect stream banks and provide grade control; (3) both powerhouse
structures would be secured and left in place during decommissioning
and an option for future reuse of the powerhouse structures would be
preserved; (4) electric generators, turbines and other equipment would
be removed; (5) both forebays would be graded and filled; and (6) canal
segments would be left in place, breached, or filled in consultation
with affected landowners, and metal and wood flume structures would be
removed. The licensee consulted with federal, state, local agencies,
and other parties with potential interest, during the license surrender
application process.
    As a result of the public scoping process and environmental site
review, the FERC staff has determined that the proposed license
surrender would constitute a major federal action significantly
affecting the quality of the human environment. Therefore, the staff
intends to prepare an environmental impact statement (EIS) on the
surrendering of the hydroelectric project

in lieu of an environmental assessment (EA). The EIS will be prepared
in accordance with the National Environmental Policy Act (NEPA).

Scoping

    The FERC staff prepared a scoping document and held public scoping
meetings on October 19, 2009 in Palo Cedro, CA and October 22, 2009 in
Redding, CA. FERC staff held public environmental site reviews of the
project on October 20 and 21, 2009. The public meetings and
environmental site reviews assisted staff in identifying the scope of
the environmental issues that should be analyzed. The results of the
scoping were extensive and indicate than an EIS should be prepared for
this project rather than an EA, as staff had initially anticipated. The
upcoming EIS will reflect input received at the scoping meetings and
justify why staff has determined that an EIS should be prepared.

Process

    The FERC staff will first issue and circulate a draft EIS to all of
the interested parties for comment. All comments filed on the draft EIS
will be analyzed by the FERC staff and considered in the final EIS
pursuant to NEPA. The FERC staff will also hold a public meeting in
California before issuing the final EIS. The staff's conclusions and
recommendations will then be presented for the consideration of the
Commission in the order reaching its final decision.
    For further information please contact the project coordinator,
CarLisa Linton at<PHONE_NUMBER> or<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-4093 Filed 2-26-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: March 12, 2008 (Volume 73, Number 49)]
[Rules and Regulations]
[Page 13136-13141]
[DOCID:fr12mr08-32]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0331; FRL-8351-7]

Spiromesifen; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues
of spiromesifen and its enol metabolite in or on bean, dry; bean,
succulent; bean, edible podded; and cowpea, forage. 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, 2008. Objections and
requests for hearings must be received on or before May 12, 2008, 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-2007-0331. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov website to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. 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 Bldg.), 2777 S. Crystal Dr.,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Shaja R. Brothers, 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 those engaged in
the following activities:
     Crop production (NAICS code 111), e.g., agricultural
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural
workers; farmers; greenhouse, nursery, and floriculture workers;
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 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 to
provide 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 EPA's tolerance regulations at
40 CFR part 180 through the Government Printing Office's pilot e-CFR
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0331 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 as required by 40 CFR part 178 on or
before May 12, 2008.
    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 this copy, identified by docket ID number
EPA-HQ-OPP-2007-0331 by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket Facility telephone number is<PHONE_NUMBER>.

II. Petition for Tolerance

    In the Federal Register of May 9, 2007 (72 FR 26375) (FRL-8128-1),
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 7E7195)
by IR-4, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The
petition requested that 40 CFR 180.607 be amended by establishing
tolerances for combined residues of the insecticide spiromesifen, (2-
oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-4-yl 3,3-
dimethylbutanoate) and its enol metabolite (4-hydroxy-3-(2,4,6-
trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on bean, edible,
podded at 1.4 ppm; bean, succulent at 0.10 ppm; bean, dry at 0.02 ppm;
cowpea, forage at 35 ppm; cattle, fat at 0.20 ppm; cattle, meat at 0.01
ppm; cattle, meat byproducts at 0.30 ppm; goat, fat at 0.20 ppm; goat,
meat at 0.01 ppm; goat, meat byproducts at 0.30 ppm; hog, fat at 0.20
ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.30 ppm; horse,
fat at 0.20 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at0.30
ppm; sheep, fat at 0.20 ppm; sheep, meat at 0.01 ppm; sheep, meat
byproducts at 0.30 ppm; and milk at 0.01 ppm. This notice referenced a
summary of the petition prepared by Bayer Crop Science, the registrant,
which is available to the public 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
revised tolerance expressions for bean, edible, podded; cowpea, forage;
milk, whole; milk, fat; in meat of cattle, goats, horses, and sheep; in
meat, byproducts, of cattle, goats, horses, and sheep; and in fat of
cattle, goats, horses, and sheep. A tolerance for cowpea, hay was also
included. The reason for these changes 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....'' These provisions were added to FFDCA by the Food Quality
Protection Act (FQPA) of 1996.
    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 the petitioned-for tolerances
for combined residues of spiromesifen on bean, dry at 0.02 ppm; bean,
succulent at 0.10 ppm; bean, edible podded at 0.80 ppm; cowpea, forage
at 30 ppm; cowpea, hay at 86 ppm; cattle, fat at 0.10 ppm; cattle, meat
at 0.02 ppm; cattle, meat byproducts at 0.15 ppm; goat, fat at 0.10
ppm; goat, meat at 0.02 ppm; goat, meat byproducts at 0.15 ppm; horse,
fat at 0.10 ppm; horse, meat at 0.02 ppm; horse, meat

byproducts at 0.15 ppm; sheep, fat at 0.10 ppm; sheep, meat at 0.02
ppm; sheep, meat byproducts at 0.15 ppm; milk at 0.01 ppm; and milk,
fat at 0.20 ppm. EPA's assessment of exposures and risks associated
with establishing the tolerances follow.

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.
    Spiromesifen shows low acute toxicity via the oral, dermal and
inhalation routes of exposure. It was neither an eye nor dermal
irritant, but showed moderate potential as a contact sensitizer in a
Magnusson and Kligman maximization assay. Acute dietary-exposure limits
for all populations, including infants and children, were not necessary
because an endpoint of concern attributable to a single exposure (dose)
was not identified from the oral toxicity studies. In addition, there
are no developmental concerns based on rat and/or rabbit developmental
toxicity studies. The rat two-generation reproduction study was
selected for chronic dietary, as well as long-term dermal- and
inhalation-exposure risk assessments.
    In the 2-generation reproduction study in rat the following effects
were noted at the lowest observed adverse effect level (LOAEL):
Significantly decreased spleen weight (absolute and relative in
parental females and F1 males) and significantly decreased growing
ovarian follicles in females. Spiromesifen shows no significant
developmental or reproductive effects, is not likely to be carcinogenic
based on bioassays in rat and mouse, and lacks in vivo and in vitro
mutagenic effects. Spiromesifen is not a neurotoxic chemical based on
results of acute and subchronic neurotoxicity studies.
    Specific information on the studies received and the nature of the
adverse effects caused by spiromesifen as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found in the document
entitled ``Spiromesifen: Human Health Risk Assessment for a Section 3
Registration on Beans;'' pages 44-52 at www.regulations.gov. The
referenced document is available in docket EPA-HQ-OPP-2007-0331.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no
appreciable risk, the toxicological level of concern (LOC) is derived
from the highest dose at which no adverse effects are observed (the
NOAEL) in the toxicology study identified as appropriate for use in
risk assessment. However, if a NOAEL cannot be determined, the lowest
dose at which adverse effects of concern are identified (the LOAEL) is
sometimes used for risk assessment. Uncertainty/safety factors (UFs)
are used in conjunction with the LOC to take into account 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. Safety is assessed for acute and chronic
risks by comparing aggregate exposure to the pesticide to the acute
population adjusted dose (aPAD) and chronic population adjusted dose
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all
applicable UFs. Short-, intermediate-, and long-term risks are
evaluated by comparing aggregate exposure to the LOC to ensure that the
margin of exposure (MOE) called for by the product of all applicable
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of
exposure will lead to some degree of risk and estimates risk in terms
of the probability of occurrence of additional adverse cases.
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for spiromesifen used for
human risk assessment can be found at http://www.regulations.gov in the
document entitled ``Spiromesifen: Human Health Risk Assessment for a
Section 3 Registration on Beans;'' pages 18-19; docket ID number EPA-
HQ-OPP-2007-0331.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to spiromesifen, EPA considered exposure under the petitioned-
for tolerances as well as all existing spiromesifen tolerances in (40
CFR 180.607). EPA assessed dietary exposures from spiromesifen 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.
    No such effects were identified in the toxicological studies for
spiromesifen; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA 1994-1996,
and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-
level residues for all commodities with existing and proposed
tolerances except for the leafy-green and leafy-Brassica vegetable
subgroups (4A and 5B). An additional metabolite, BSN 2060-4-
hydroxymethyl, was observed in the metabolism studies of lettuce only.
Since this metabolite's toxicity is expected to be comparable to the
parent compound, it was included in the risk assessment for leafy crops
(subgroups 4A and 5B), but not in the tolerance expression. To account
for this additional toxicity exposure, the recommended tolerance level
was multiplied by a correction factor of 1.3x. For all commodities,
100%CT as well as DEEM\TM\ Version 7.81 default processing factors were
used.
    iii. Cancer. Spiromesifen has been classified as ``not likely to be
carcinogenic to humans.'' Therefore, a cancer dietary risk assessment
was not performed.
    2. Dietary exposure from drinking water.The Agency lacks sufficient
monitoring data to complete a comprehensive dietary exposure analysis
and risk assessment for spiromesifen 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 environmental fate characteristics of
spiromesifen. 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.
    Parent spiromesifen is not likely to persist in the environment as
it readily undergoes both biotic and abiotic degradation; however, its
primary degradate BSN2060 is expected to persist. While parent
spiromensifen strongly sorbs to sediment and is not likely to be
mobile, its enol degradate does not sorb to sediment and is expected to
leach into groundwater. Spiromesifen has limited solubility in water
and is some cases has been

reported to have a practical solubility limit of 40 to 50 [mu]g/L. The
pesticide degrades primarily through aerobic soil metabolism and
hydrolysis; however, in clear shallow water it will readily undergo
photolysis. Field studies indicate that spiromesifen readily dissipates
with dissipation half lives ranging from 2 to 10 days. The compound is
not likely to bioconcentrate appreciably given its relatively rapid
degradation and depuration.
    Spiromesifen and BSN 2060-enol are the predominant residues in
drinking water. BSN 2060-enol may account for 75% of the total acute
exposure and for over 90% for chronic exposure. Estimated drinking
water concentrations (EDWCs) were generated for the total toxic residue
which includes spiromesifen, the -enol and -carboxy metabolites, and
unextracted material. The highest estimated surface water
concentrations occurred with the NC sweet potato scenario.
    Based on the Pesticide Root Zone Model /Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated environmental concentration (EEC) of
spiromesifen for chronic exposure is estimated to be 11 parts per
billion (ppb) for surface water. The EEC for chronic exposure is
estimated to be 28 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 28 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).
    Spiromesifen 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 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 spiromesifen and any other
substances and spiromesifen 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 spiromesifen 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 EPA's Web site 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 (``10X'') 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. This additional
margin of safety is commonly referred to as the FQPA safety factor. 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 FQPA
safety factor value based on the use of traditional UFs and/or special
FQPA safety factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of rats or rabbits to in utero and/or
postnatal exposure to spiromesifen. In the prenatal developmental
toxicity studies in rats and rabbits and in the two-generation
reproduction study in rats, developmental toxicity to the offspring
occurred at equivalent or higher doses than parental toxicity.
    3. Conclusion. EPA has determined that reliable data show that it
would be safe for infants and children to reduce the FQPA safety factor
to 1X. That decision is based on the following findings:
    i. The toxicity database for spiromesifen is complete.
    ii. There is no indication that spiromesifen is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
    iii. There is no evidence that spiromesifen results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100%CT and tolerance-level residues or higher. Conservative ground
and surface water modeling estimates were used. Residential exposure is
not expected as spiromesifen will be registered for agricultural and
greenhouse/ornamental uses only. These assessments will not
underestimate the exposure and risks posed by spiromesifen.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and
cPAD are calculated by dividing the LOC by all applicable UFs. For
linear cancer risks, EPA calculates the probability of additional
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to
ensure that the MOE called for by the product of all applicable UFs is
not exceeded.
    1. Acute risk. No such effects were identified in the toxicological
studies for spiromesifen; therefore, acute exposure is not expected.
    2. Chronic risk.Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to
spiromesifen from food and water will utilize 42% of the cPAD for the
population group children 3-5 years old (the greatest exposure). There
are no residential uses for spiromesifen that result in chronic
residential exposure to spiromesifen.
    3. Short and intermediate-term risk. Short and Intermediate-term
aggregate exposure takes into account residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
    Spiromesifen 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.
    4. Aggregate cancer risk for U.S. population. Spiromesifen has been
classified as ``not likely to be carcinogenic to humans.'' Spiromesifen
is not expected to pose a cancer risk.
    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 spiromesifen residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology, high performance liquid
chromatography/mass spectroscopy (HPLC/MS/MS)/ Method 00631/M001, 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>; e-mail address<EMAIL_ADDRESS>
B. International Residue Limits

    No Codex, Canadian, or Mexican MRLs have been established for
residues of spiromesifen and its metabolites.

C. Explanation of Tolerance Revisions

    1. Bean, edible podded and cowpea, forage. The tolerances were
revised based on analysis with the Agency's tolerance spreadsheet in
accordance with the Guidance for Setting Pesticide Tolerances Based on
Field Trial Data SOP.
    2. Cowpea, hay. After reviewing the cowpea residue data, EPA
determined an additional cowpea tolerance was necessary on cowpea hay.
    3. Livestock feed and milk. Based on the dietary exposure levels
and the residue data from an available ruminant feeding study, data
indicate that a tolerance of 0.01 ppm is needed in milk, whole, 0.20
ppm in milk, fat, 0.02 ppm is needed for residues of spiromesifen in
the meat of cattle, goats, horses, and sheep, 0.15 ppm in meat,
byproducts, of cattle, goats, horses, and sheep, and 0.10 in the fat of
cattle, goats, horses, and sheep. Based on the transfer coefficients
for livestock tissues and the relatively low dietary burden for swine
of 0.04 ppm for spiromesifen, tolerances in hogs are not needed.

V. Conclusion

    Therefore, the tolerances are established for combined residues of
spiromesifen, (2-oxo-3-(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-
4-yl 3,3-dimethylbutanoate) and its enol metabolite (4-hydroxy-3-
(2,4,6-trimethylphenyl)-1-oxaspiro[4.4]non-3-en-2-one), in or on bean,
dry at 0.02 ppm; bean, succulent at 0.10 ppm; bean, edible podded at
0.80 ppm; cowpea, forage at 30 ppm; cowpea, hay at 86 ppm; cattle, fat
at 0.10 ppm; cattle, meat at 0.02 ppm; cattle, meat byproducts at 0.15
ppm; goat, fat at 0.10 ppm; goat, meat at 0.02 ppm; goat, meat
byproducts at 0.15 ppm; horse, fat at 0.10 ppm; horse, meat at 0.02
ppm; horse, meat byproducts at 0.15 ppm; milk at 0.01 ppm; milk, fat at
0.20 ppm; sheep, fat at 0.10 ppm; sheep, meat at 0.02 ppm; and sheep,
meat byproducts at 0.15 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, 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) 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 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.
    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 section 408(n)(4) of FFDCA. 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 6, 2000) do not apply to this rule. In addition, This
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) (Public Law 104-4).
    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).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report 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.

    Dated: March 4, 2008.
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 180.607 is amended by alphabetically adding commodities to
the table in paragraph (a)(1), and by revising the table in paragraph
(a)(2) to read as follows:

Sec.  180.607  Spiromesifen; tolerances for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Bean, dry..................................................         0.02
Bean, edible podded........................................         0.80
Bean, succulent............................................         0.10
                                * * * * *
Cowpea, forage.............................................           30

Cowpea, hay................................................           86
                                * * * * *
------------------------------------------------------------------------

    (2) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Cattle, fat................................................         0.10
Cattle, meat...............................................         0.02
Cattle, meat byproducts....................................         0.15
Goat, fat..................................................         0.10
Goat, meat.................................................         0.02
Goat, meat byproducts......................................         0.15
Horse, fat.................................................         0.10
Horse, meat................................................         0.02
Horse, meat byproducts.....................................         0.15
Milk.......................................................         0.01
Milk, fat..................................................         0.20
Sheep, fat.................................................         0.10
Sheep, meat................................................         0.02
Sheep, meat byproducts.....................................         0.15
------------------------------------------------------------------------

[FR Doc. E8-4920 Filed 3-11-08; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register: October 26, 2010 (Volume 75, Number 206)]
[Notices]
[Page 65641]
[DOCID:fr26oc10-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Risk Communication Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    The Food and Drug Administration (FDA) is announcing an amendment
to the notice of meeting of the Risk Communication Advisory Committee.
This meeting was announced in the Federal Register of September 20,
2010 (75 FR 57279). The amendment is being made to reflect a change in
the Agenda portion of the document. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Lee L. Zwanziger, Office of Policy,
Planning and Budget, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 3278, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:
301-847-8611, e-mail<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area), code<PHONE_NUMBER>. Please call the Information Line for up-to-date
information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of September 20,
2010, FDA announced that a meeting of the Risk Communication Advisory
Committee would be held on November 8 and 9, 2010. On page 57280, in
the first column, the Agenda portion of the document is changed to read
as follows:
    Agenda: On November 8 and 9, 2010, the Committee will hear and
discuss developments in FDA's ongoing communications programs, such as
FDA's Strategic Plan for Risk Communication, FDA's Transparency
Initiative, foodborne outbreaks and related recall communications, and
the challenges of effectively communicating with patients and
caregivers about appropriate use of medical devices when a patient is
prescribed a medical device for home use.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: October 21, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27060 Filed 10-25-10; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 29, 2005 (Volume 70, Number 228)]
[Notices]
[Page 71541-71542]
[DOCID:fr29no05-71]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[FEMA-1615-DR]

Kansas; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of Kansas (FEMA-1615-DR), dated November 15,
2005, and related determinations.

DATES: Effective November 15, 2005.

FOR FURTHER INFORMATION CONTACT: Magda Ruiz, Recovery Division, Federal
Emergency Management Agency, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated November 15, 2005, the President declared a major disaster under
the authority of the Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

    I have determined that the damage in certain areas of the State
of Kansas, resulting from severe storms and flooding from October 1-
2, 2005, is of sufficient severity and magnitude to warrant a major
disaster declaration under the Robert T. Stafford Disaster Relief
and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford
Act). Therefore, I declare that such a major disaster exists in the
State of Kansas.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide Public Assistance in the
designated areas and Hazard Mitigation throughout the State, and any
other forms of assistance under the Stafford Act you may deem
appropriate. Consistent with the requirement that Federal assistance
be supplemental, any Federal funds provided under the Stafford Act
for Public Assistance and Hazard Mitigation will be limited to 75
percent of the total eligible costs. If Other Needs Assistance under
Section 408 of the Stafford Act is later requested and warranted,
Federal funding under that program will also be limited to 75
percent of the total eligible costs.
    Further, you are authorized to make changes to this declaration
to the extent allowable under the Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Acting Director, under
Executive Order 12148, as amended, Thomas J. Costello,

of FEMA is appointed to act as the Federal Coordinating Officer for
this declared disaster.

    I do hereby determine the following areas of the State of Kansas
to have been affected adversely by this declared major disaster:
Atchison, Jackson, Jefferson, Leavenworth, and Shawnee Counties for
Public Assistance.
    All counties within the State of Kansas are eligible to apply
for assistance under the Hazard Mitigation Grant Program.

(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 Program; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services Program; 97.034,
Disaster Unemployment Assistance (DUA); 97.046, Fire Management
Assistance; 97.048, Individuals and Households Housing; 97.049,
Individuals and Households Disaster Housing Operations; 97.050,
Individuals and Households Program--Other Needs; 97.036, Public
Assistance Grants; 97.039, Hazard Mitigation Grant Program.)

R. David Paulison,
Acting Director, Federal Emergency Management Agency, Department of
Homeland Security.
 [FR Doc. E5-6657 Filed 11-28-05; 8:45 am]