[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60137-60140]
[FR Doc No: 2019-24150]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2019-0899]

Special-Issuance Medical Certification: Diabetes Protocol for
Applicants Seeking To Exercise Airline Transport, Commercial, or
Private Pilot Privileges

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice; request for comment.

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SUMMARY: With this notice, the Federal Aviation Administration (FAA)
informs applicants for airman medical certification with insulin-
treated diabetes mellitus (ITDM) of a new protocol available to
evaluate pilots seeking to exercise pilot privileges as airline
transport, commercial, or private pilots. The FAA may only certificate
pilots with ITDM through the special-issuance process with case-by-case
assessment of overall risk and available risk mitigation. Previously
available medical science, treatment, and monitoring have allowed the
FAA to safely provide special issue third-class medical certificates
for private pilot privileges since 1996, but was not sufficient to meet
the higher levels of safety demanded for applicants considered for
airline transport or commercial pilot duties. The new FAA risk
assessment protocol, based on established advances in medical science
since 1996, makes it possible to mitigate flight safety risk so that
applicants seeking first- or second-class special-issuance medical
certification may be considered for the exercise of either airline
transport or commercial pilot privileges. Applicants for third-class
special issuance may apply under the existing third-class-only protocol
or the new protocol.

DATES: The protocol is effective November 7, 2019.
    Send comments on or before January 6, 2020.

ADDRESSES: You may send comments identified by docket number FAA-2019-
0899 using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
     Mail: Docket Operations, M-30; U.S. Department of
Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West
Building Ground Floor, Washington, DC 20590-0001.
     Hand Delivery or Courier: Take comments to Docket
Operations in Room W12-140 on the ground floor of the West Building,
1200 New Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.
     Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments
from the public to better inform its rulemaking process. DOT posts
these comments, without edit, including any personal information the
commenter provides, to http://www.regulations.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Judi Citrenbaum, Office of Aerospace
Medicine, Federal Aviation Administration, 800 Independence Avenue SW,
Washington, DC 20591; telephone<PHONE_NUMBER>, email.
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

FAA Experience Applying Special-Issuance Procedures for Diabetes

    Under Title 14 of the Code of Federal Regulations (14 CFR),
Sec. Sec.  67.113(a), 67.213(a), and 67.313(a), insulin-treated
diabetes mellitus (ITDM) is considered medically disqualifying for
pilots. The Federal Air Surgeon has discretion under 14 CFR 67.401 to
authorize special issuance of airman medical certificates to applicants
who are otherwise disqualified. Historically, the FAA has used this
discretion to special issue only third-class medical certificates to
applicants with ITDM

seeking to exercise private pilot privileges.
    In determining whether an authorization for special issuance may be
granted to an applicant, the Federal Air Surgeon considers whether the
privileges permitted by the class of medical certificate requested can
be performed without endangering public safety for the duration of the
medical certificate. The FAA must always consider risk when
implementing its licensing and credentialing programs, and the medical
certification process is no exception. As specified in 14 CFR 67.401,
the Federal Air Surgeon ``considers the freedom of an airman,
exercising the privileges of a private pilot certificate, to accept
reasonable risks to his or her person and property that are not
acceptable in the exercise of commercial or airline transport pilot
privileges, and, at the same time, considers the need to protect the
safety of persons and property in other aircraft and on the ground.''
Much less risk is acceptable in the exercise of commercial or airline
transport pilot privileges in order to protect public safety.
    Long-term medical risks associated with diabetes include
cardiovascular, neurological, ophthalmological, and renal
complications. These factors pose additional hazards to aviation and
require special scrutiny. Of particular concern with insulin-treated
diabetes, more so than for oral hypoglycemic treated diabetes, is the
short-term or immediate risks posed by hypoglycemia or low blood
glucose. Hypoglycemia can produce impaired cognitive function,
seizures, unconsciousness, and even death. The functional
incapacitation associated with hypoglycemia may occur subtly and be
undetected by the individual or others. Inadequately controlled
diabetes (with resulting high blood sugar [hyperglycemia]) also can
lead to impaired function and, effectively, incapacitation. Thus, the
symptoms that result from both diabetes and its treatment can affect
flight safety.
    The FAA has incrementally updated the special-issuance medical
certification protocol for applicants with diabetes. The FAA initially
did so, in the early 1980's, for individuals who control their diabetes
with diet and non-insulin hypoglycemic drugs. In 1996, the FAA began
allowing insulin use for third-class medical certification, which
limits the applicant to exercising private pilot privileges. This
incremental approach has been very successful, and the FAA has now
authorized approximately 500 ITDM pilots for third-class medical
certification. The third-class special issuance protocol, in part,
requires a process of finger-stick glucose testing before and during
flight. The agency has a separate, internal program under FAA Order
3930.3B (Air Traffic Control Specialist Health Program) to permit FAA
Air Traffic Control Specialists (ATCSs) with ITDM to continue their
safety-related duties.
    Applicants with diabetes considered for third-class, special-
issuance medical certification are carefully evaluated and must submit
to monitoring under a specific medical protocol, just as they would for
any other specifically disqualifying medical condition under Part 67.
Special-issuance conditions include careful evaluation of the
individual's medical history, risk stratification, and the efficacy of
the individual in controlling the disease. To develop diabetes
protocols, the FAA considered the input of expert endocrinologists and
diabetes specialists. The FAA continually reviews its protocols (for
diabetes and other diseases) to ensure they remain viable and
appropriate given ever-evolving medical advances. In this regard, the
agency validates its experience and ensures that safety of flight is
maintained.

Discussion

Recommendations To Expand the Protocol

    Authorization for ITDM pilots to exercise pilot privileges beyond
private pilot has been a topic of much discussion for several years
within the aviation sector. While the FAA has discretion under Sec.
67.401 to consider allowing ITDM special issuance for higher-rated
pilots, it has chosen to proceed cautiously. The American Diabetes
Association and several affected pilots have urged the FAA to update
its special-issuance process for ITDM beyond third-class medical
certification by developing an ITDM special-issuance protocol to allow
the exercise of commercial and airline transport pilot privileges.
    In 2013, the FAA suggested the American Diabetes Association
consider convening a panel of experts to recommend how to risk stratify
ITDM pilots for consideration beyond the private pilot certification
level, to include recommending a protocol for identifying a subset of
individuals at very low risk for hypoglycemia. The American Diabetes
Association panel concluded that updating the protocol to airline
transport and commercial pilots was justified. In their findings
submitted to the FAA, the ADA panel indicated the following:

    The treatment of insulin treated diabetes has improved
dramatically over the past thirty-five years with the advent of
accurate determinations of blood glucose levels using meters with
sophisticated memory chips and built in analytical programs. These
developments also include continuous glucose monitors, continuous
subcutaneous insulin infusion pumps, and improvements in short and
long acting insulin analogues. These improvements permit real-time
measurement of blood glucose levels, and have made it far easier for
people with insulin treated diabetes to maintain near-normal blood
glucose levels. This, in turn, dramatically reduces the risk of both
short and long term complications of diabetes with significant
reduction in the rate of both hyper- and hypoglycemic glucose
levels. Careful monitoring and management of insulin treated
diabetes is now routine and the processes involved have become
streamlined such that school children often self-manage their
glucose levels with minimal or no adult intervention.

    In addition, the ADA panel concluded the following:

    After considering all the evidence and clinical experience, the
expert panel concluded that there are pilots with insulin treated
diabetes whose risk of incapacitation in flight is equivalent to, or
lower than pilots who do not have insulin treated diabetes. Their
risk, like the risk presented by pilots who do not have insulin
treated diabetes, is nonzero, but extremely improbable. It is the
recommendation of the Expert Panel that FAA policy should be updated
to reflect current diabetes medicine and permit such pilots medical
certification at the first, second, and third class level.

    The FAA reviewed the ADA 2013 recommendations and determined they
provided impetus for a way forward. At the time, however, FAA medical
experts and consultants were not satisfied that the level of medical
treatment and technology was sufficiently advanced to consider moving
forward with higher-level ITDM certification. As such, the FAA
continued to pursue identifying a protocol that could be used for
identifying a subset of individuals at very low risk for hypoglycemia.
Unable to identify such a subset, the FAA turned to its own data on
third-class ITDM pilots.

FAA Study of Third-Class ITDM Protocol

    In 2015, the FAA Civil Aerospace Medical Institute (CAMI) evaluated
the experience of U.S. private pilots flying with ITDM in a study
entitled: ``Risk Assessment in the U.S. Pilot Population from 1983 to
2005: Diabetes Prevalence and Flight Safety.'' \1\ CAMI conducted this
study to evaluate trends for obesity and diabetes as reflected in the
U.S. pilot population and explore the effects on flight safety and
longevity of pilots

with these conditions. The study noted that the prevalence of diabetes
and obesity has increased worldwide, almost doubling between 1980 and
2014. This study found that the number of pilots with diabetes in the
U.S. active pilot population rose from 2,768 in 1983 to 10,806 in 2005,
an almost four-fold increase, reflecting both the increased prevalence
in the population and the 1996 change in FAA policy. Limited prior
evidence had suggested that aviators with reported diabetes controlled
by hypoglycemic medication and diabetes controlled by diet alone were
at greater accident risk than aviators without these conditions. The
study reviewed NTSB accident reports from 1997-2005, reporting only 18
general aviation events involving insulin-dependent pilots.\2\ Two
accidents resulted in fatalities; one resulted in non-fatal injuries,
and only one was conducted under instrument flight rules. All but one
incident (mechanical, not pilot-related) were human factors-related and
attributed to pilot error. The study concluded that, overall, the NTSB
data did not indicate that diabetes directly contributed to the
accidents.
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    \1\ See DOT/FAA/AM-15/5; March 2015.
    \2\ Id. at 11.
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Monitoring Innovations

    Subsequent to the 2015 CAMI study, the FAA continued to follow the
advances in diabetes medical science, including innovative progress
with diabetes treatment (e.g., medications), but most particularly with
an individual's ability to efficiently self-monitor using continuous
glucose monitoring (CGM) devices. CGM is wearable technology that
provides a reliable and accepted means for accurately monitoring blood
sugar levels, and predicting when a change is occurring. CGM
monitoring, along with standard clinical follow up, reduces the risk of
hypoglycemia, both inflight and outside the flight environment. CGM
technology allows affected pilots to address their particular situation
with good reassurance regarding short- and long-term stability. CGM
usage allows the FAA to identify a low-risk subset and consider
applicants whose glycemic stability is sufficiently controlled for
safety of flight, even for commercial operations. Whereas the existing
third-class protocol of finger-stick glucose testing before and during
flight has proven sufficient at the private pilot level, the FAA has
determined that CGM monitoring sufficiently increases the level of
safety necessary to effectively validate higher-level piloting. With
CGM, the FAA has been able to develop evidence-based protocols that
ensure that each applicant vetted and granted a special issuance to
their medical certificate is capable of maintaining diabetic control
appropriate for safety of flight.

Experience of Other Countries Allowing ITDM Pilots To Exercise Pilot
Privileges Commercially

    The FAA is aware of two civil aviation authorities (CAAs) with
experience in allowing individuals with ITDM to exercise their
equivalent of commercial and airline transport pilot privileges. The
Canadian CAA has approximately two decades of experience implementing a
more flexible ITDM policy for commercial operations. Pilots (both
commercial and airline transport pilots) with ITDM also are considered
for medical certification in the United Kingdom. These CAAs link
operational limitations and protocols to the medical certificate that
must be strictly followed. These protocols may include limiting flights
to multi-crew operations; informing the other pilot of the diabetes
diagnosis; and training the other pilot on the recognition and
treatment of hypoglycemia. Commercial pilots with ITDM from other CAAs
have been flying internationally, including in U.S. airspace, for many
years with no reported adverse impact on safety.
    While the ITDM protocols from other CAAs have resulted in safe
operations, the FAA has decided to take a different approach that it
believes will enhance safety. Rather than imposing operational
limitations and protocols via the medical certificate,\3\ the FAA has
developed an approach that is focused on the applicant's health. The
FAA's ITDM protocol employs updated and proven medical technologies and
best practices that allow for continuous monitoring and oversight of
the ITDM individual, thereby reducing the potential for incapacitation.
Under the FAA's ITDM protocol, the FAA will issue a first- or second-
class special issuance medical certificate to an ITDM applicant only if
the FAA has determined that safety of flight can be maintained with the
use of CGM technology.\4\
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    \3\ The FAA notes that it may not condition the continued effect
of any first-class medical certificate based on compliance with
functional limitations. See 14 CFR 67.401(d)(4); see also Delta Air
Lines, Inc., 490 F. Supp. at 918-919 (finding the FAA cannot
regulate, restrict, or place functional limitations on the cockpit
duties an airline transport pilot may perform because it usurps the
authority of the airline).
    \4\ As with all cases the FAA reviews, an authorization for
special issuance will be based on a favorable determination that
safety of flight can be maintained. See 14 CFR 67.401(a).
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Exercising Pilot Privileges Internationally With an FAA Special-
Issuance Medical Certificate

    Under International Civil Aviation Organization (ICAO) standards,
diabetes controlled by insulin is considered specifically disqualifying
just as it is in the United States. However, ICAO Annex 1 standard
<IP_ADDRESS> (like U.S. regulation 14 CFR 67.401) applies a flexibility
clause allowing signatory states (like the United States) to use
discretion in issuing medical certificates. U.S. regulation refers to
this discretion as special issuance, whereas ICAO standard refers to it
as ``accredited medical conclusion'' as follows:

    <IP_ADDRESS> If the medical Standards prescribed in [ICAO Annex 1]
Chapter 6 for a particular license are not met, the appropriate
Medical Assessment shall not be issued or renewed unless the
following conditions are fulfilled:
    (a) accredited medical conclusion indicates that in special
circumstances the applicant's failure to meet any requirement,
whether numerical or otherwise, is such that exercise of the
privileges of the license applied for is not likely to jeopardize
flight safety;
    (b) relevant ability, skill and experience of the applicant and
operational conditions have been given due consideration; and
    (c) the license is endorsed with any special limitation or
limitations when the safe performance of the license holder's duties
is dependent on compliance with such limitation or limitations.

    The ICAO Manual of Civil Aviation Medicine (Doc 8984) states:

    The methods used to treat diabetic patients have improved over
recent decades and individuals that require insulin to maintain
satisfactory blood glucose levels may apply, or re-apply, for a
license to fly or to undertake air traffic control work. Although
Annex 1, <IP_ADDRESS> (and <IP_ADDRESS>, <IP_ADDRESS> for Class 2 and 3,
respectively) normally precludes certification of insulin-treated
diabetic applicants for any class of Medical Assessment, several
Contracting States permit such applicants to exercise license
privileges, utilizing the flexibility Standard <IP_ADDRESS>, and others
may wish to consider doing so.

    U.S. pilots flying under special issuance on U.S.-registered
aircraft have always been recognized as ICAO-compliant. They have been
accepted flying in airspace outside of the United States, just as the
United States accepts foreign air carrier pilots with special issuance
(including for ITDM) exercising pilot privileges within U.S. airspace.

New FAA Protocol

Rationale for Considering ITDM Applicants Seeking To Exercise Higher-
Rated Pilot Privileges

    After extensive deliberation and careful consideration, the FAA has
developed a new FAA ITDM protocol to allow special issuance, based on
CGM technology, for any class of medical certificate for ITDM
individuals who meet specific criteria. As discussed, several factors
contributed to the FAA's decision to develop a new ITDM protocol: Input
from the expert medical community; years of experience with private
pilots being special-issued for ITDM; the 2015 CAMI study validating
safety; the experience of other CAAs with no adverse impact on flight
safety; medical advances in the treatment of diabetes; and maturation
of CGM technology.
    Individuals with ITDM seeking to exercise airline transport or
commercial pilot privileges may submit an application via MedXpress for
medical review and consideration. CGM use will be implemented for
first- or second-class special issuance medical certification for ITDM
applicants. As with all cases the FAA reviews, an authorization for
special issuance will be based on a favorable determination that safety
of flight can be maintained. Also, applicants for third-class special
issuance may apply under the existing protocol or the new CGM-based
protocol.
    Interested applicants should work with their Aviation Medical
Examiner, appropriate medical specialists (endocrinologist,
cardiologist, ophthalmologist, etc.), and the FAA to coordinate
submission of the appropriate documentation needed for consideration.
For consideration, potential applicants will need to demonstrate
stability and adequate control of ITDM using CGM technology for a
minimum of at least 6 months. In keeping with 14 CFR 67.413
requirements to provide the FAA with medical history to ensure
appropriate fitness for flight, applicants applying for the new
protocol must be able to provide the following:

(1) Initial comprehensive report from the treating, board-certified
endocrinologist
(2) Initial comprehensive laboratory panel
(3) Finger-Stick Blood Sugar (FSBS) glucose monitoring data
(4) Continuous Glucose Monitoring (CGM) data for at least the preceding
6-month period (using a device legally marketed in the United States in
accordance with Food and Drug Administration requirements and
containing protocol-specific features needed for appropriate in-flight
monitoring.).
(5) Excel spreadsheet or similar that identifies CGM data for all
flights for the past 6 months and any actions taken to address low or
high glucose levels.
(6) Eye evaluation (from a board certified ophthalmologist)
(7) Cardiac risk evaluation (from a board certified cardiologist)

    For more information, applicants interested in applying for an ITDM
special issuance should consult the specific ITDM protocols, including
CGM features needed for proper in-flight monitoring, by searching
``ITDM'' in the Guide for Aviation Medical Examiners at: www.faa.gov/go/ITDM.
    Individuals who may have submitted an application to the FAA in
advance of this announcement will be contacted if further information
is needed to process their submission.
    This notice is not legally binding in its own right and will not be
relied on by FAA as a separate basis for affirmative enforcement action
or other administrative penalty. Unless otherwise required by statute
or regulation, conformity with the new protocol described here is
voluntary only. Nonconformity will not affect rights or obligations
under existing statutes and regulations.

Inviting Comments

    The FAA is requesting comments on the new ITDM protocol described
herein. The agency will consider comments received on or before January
6, 2020. The new ITDM protocol may be revised based on comments
received.

    Issued in Washington, DC, on October 30, 2019.
Michael A. Berry,
Federal Air Surgeon.
[FR Doc. 2019-24150 Filed 11-6-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 75, Number 244 (Tuesday, December 21, 2010)]
[Rules and Regulations]
[Pages 79961-79964]
[FR Doc No: 2010-32018]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Parts 154 and 155

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 112

[Docket No. USCG-2010-0592; EPA-HQ-OPA-2010-0559]
RIN 1625-AB49; 2050-AG63

Temporary Suspension of Certain Oil Spill Response Time
Requirements To Support Deepwater Horizon Oil Spill of National
Significance (SONS) Response

AGENCIES: Coast Guard, DHS, and Environmental Protection Agency.

ACTION: Notice of no further regulatory action and alternative
arrangements.

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SUMMARY: The Coast Guard and the Environmental Protection Agency (EPA)
announce that we have considered the comments, materials, and evidence
received in response to the joint emergency temporary interim rule
issued on June 30, 2010, and do not intend to take further regulatory
action regarding the rule. As such, the rule will expire as scheduled
on December 31, 2010. The Coast Guard and EPA also provide notice of
the alternative arrangements under the National Environmental Policy
Act used for the joint emergency temporary interim rule.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of dockets USCG-2010-0592 and EPA-HQ-OPA-2010-0559
and are available online by going to http://www.regulations.gov,
inserting USCG-2010-0592 or EPA-HQ-OPA-2010-0559 in the ``Keyword''
box, and then clicking ``Search.'' They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays; and EPA Docket
Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW.,
Washington, DC 20460, Public Reading Room, between 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the EPA Docket Center Public Reading Room is<PHONE_NUMBER>,
and the telephone number to make an appointment to view the docket is
202-566-0276.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail:
    Coast Guard: (Facilities) Mr. David Condino, Ports and Facilities
Division, Coast Guard, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>(Vessels) LCDR Ryan Allain, Office of Vessel
Activities, Coast Guard, telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the USCG-2010-
0952 docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.
    EPA: Troy Swackhammer, U.S. Environmental Protection Agency,
telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 20, 2010, the Mobile Offshore
Drilling Unit (MODU) ``Deepwater Horizon'' exploded and sank, causing
an unprecedented discharge of crude oil into the Gulf of Mexico, which
was thereafter declared a ``Spill of National Significance'' (SONS). On
April 24, 2010, the Commandant of the Coast Guard designated a Federal
On-Scene Coordinator (FOSC) to coordinate Federal and State responses
to the oil spill.
    On June 16, 2010, the FOSC for the Deepwater Horizon SONS
determined, after consulting with appropriate Federal and State
agencies, that an adequate number of available oil spill response
resources could not be employed in a timely manner to recover the oil
released from the Deepwater Horizon SONS. (Memorandum from Rear Admiral
J.A. Watson, FOSC BP Deepwater Horizon Oil Spill, to National Incident
Command (June 16, 2010), available in the docket for this rulemaking).
    In response to the FOSC's determination, on June 30, 2010, the
Coast Guard and EPA issued a joint emergency temporary interim rule
permitting oil spill removal organizations (OSROs) and facilities and
vessels with oil spill response resources to relocate those resources
to the Gulf of Mexico Deepwater Horizon SONSat the FOSC's request. 75
FR 37712. The rule also confirmed that the FOSC for the Deepwater
Horizon SONS requested that the Armed Forces relocate response
resources, in particular those of the Navy, from their current
locations within the continental United States to the Gulf of Mexico to
aid in the response to the Deepwater Horizon SONS.
    The Navy did relocate response resources to the Deepwater Horizon
SONS. While many spare State and privately owned resources had already
relocated to the Gulf of Mexico before publication of the rule, no
State or private entity relocated response resources to the SONS under
the provisions of the rule.
    The Coast Guard and EPA also requested comments on the rule, and
stated that we would consider those comments and any other materials or
evidence received from the field on an ongoing basis every thirty days
to determine if changes to the rule might be necessary. The comment
period closed on August 16, 2010, with the Coast Guard and EPA
receiving 27 comments. We discuss those comments below. Neither the
Coast Guard nor EPA has received comments since the close of the
comment period. Although the rule will expire as scheduled on December
31, 2010, Coast Guard and EPA will continue to consider any new or
additional comments, material or evidence related to the provisions of
the rule until that date. If we decide to make changes to the rule
before its expiration, we will publish another joint notice, or other
appropriate document, in the Federal Register.
    For this emergency rulemaking, and in accordance with Council On
Environmental Quality (CEQ) Regulations Implementing the Procedural
Requirements of the National Environmental Policy Act (40 CFR parts
1500-1508) and the National Environmental Policy Act of 1969 (NEPA) (43
U.S.C. 4321-4370f), the Coast Guard, with the assistance of EPA,
consulted with CEQ about alternative arrangements pursuant to 40 CFR
1506.11. The Coast Guard, with the assistance of EPA, continued to
consult with CEQ as well as with the National Oceanic and Atmospheric
Administration (NOAA) and other key authorities in order to determine
appropriate environmental impact analysis. A discussion of these
consultations and determinations is below in B. Alternative
Arrangements under NEPA. As stated above and discussed in greater
detail below, the rule will expire as scheduled on December 31, 2010,
without changes.

A. Discussion of Comments

    The Coast Guard and EPA received 8 letters containing 27 comments
in response to the request for comments on the rule. Commenters
included individuals; an organization that represents companies that
own, operate or charter tankers, ships, and other merchant vessels
engaged in domestic

and international trade; an organization representing State
environmental and health agencies; and a trade association representing
companies involved in all aspects of the oil and natural gas industry.
We also received comments from the Makah Tribal Council (MTC), and
joint comments from the Governor of Washington and the Governor of
Oregon. The Coast Guard and EPA responded directly in writing to MTC
and the Governors. Those comments and responses, together with all
other public comments, are available in the docket for this rulemaking.
Also in the docket is a summary of an in-person communication that
occurred on July 1, 2010, between Coast Guard personnel and OSRO
community representatives regarding the rule. The in-person
communication touched on concerns and questions about the substance of
the rule, as well as questions relating to implementation of the rule.
These concerns and questions and Coast Guard responsive comments are
included in the summary of the communication, and are covered in the
discussion below.
    Several of the comments expressed support for the Coast Guard and
EPA efforts to respond to the Deepwater Horizon SONS, and we appreciate
the statements of support. Several other comments provided opinions
about the causes and effects of the oil spill. The Coast Guard and EPA
appreciate these commenters' participation in this rulemaking, however,
such comments are beyond the scope of this rulemaking and are not
addressed in this document. The remaining comments addressed the rule
and are discussed by topic below.
1. Plan Holder Liability
    Commenters were concerned about plan holder liability for damages
and penalties if a spill occurred in their original location after the
plan holder already contractually released its spill response providers
and equipment for use in the response to the Deepwater Horizon SONS.
Commenters were also concerned about liability under State requirements
as well as other penalties, such as natural resource damages, under
other Federal and State law.
    Response: The intent of the rule is to make available more response
resources for use in responding to the Deepwater Horizon SONS by
relieving certain Coast Guard and EPA regulatory requirements. Through
this rule, the Coast Guard and EPA encouraged plan holders to relieve
their contracted-OSROs of certain responsibilities in order for those
OSROs to be available to aid in responding to the Deepwater Horizon
SONS. The Coast Guard and EPA coordinated on the rule because many oil
spill response plans address both Coast Guard and EPA oil spill
response requirements. The rule was not meant to address all sources of
potential plan holder liability, including other Federal requirements
or State requirements.
2. Oil Spill Response Resources Return Time
    Several comments noted concerns about the return of assets to
original locations. One comment expressed concern that the rule does
not contain a timetable for returning assets used in response to the
Deepwater Horizon SONS. Other comments noted the distances and travel
time for response assets from the West Coast, especially for larger
vessels, to deploy to the Gulf in response to the Deepwater Horizon
SONS and to return to the assets' original locations if needed to
respond to an oil spill in those locations.
    Response: The rule does not address return times for assets
relocated in support of the response to the Deepwater Horizon SONS,
because under the rule such issues, including the relative
environmental impacts and other risks and impacts of the FOSC
requesting and accepting offers for specific response resources from
locations outside the Gulf of Mexico, are coordinated at the local
level with the cognizant Captains of the Port (COTPs), Regional
Response Teams, and Area Committees.
    Additionally, in the letter to the Governors of Washington and
Oregon dated September 3, 2010, (available in the docket) the Coast
Guard and EPA specifically stated: ``Any decision to request or accept
[deployment of equipment or personnel that would result in the loss of
response capability below worst case and maximum most probable
discharge response time requirements in the Pacific Northwest] will
consider carefully the distances and travel time from the West Coast to
the Gulf Coast spill.''
3. Adequate Coverage in Regions Outside the Gulf of Mexico
    Comments addressed concerns about whether the Average Most Probable
Discharge and Small Discharge standards in the rule provided adequate
coverage, especially for the West Coast and Pacific Northwest, as well
as delays in an adequate number of response resources responding to any
oil spill outside of the Gulf Region. One comment noted that almost all
new response equipment manufactured/built during the Deepwater Horizon
SONS will likely be purchased/deployed for response to the Deepwater
Horizon SONS, further lengthening the time to return other locations to
full preparedness levels under current response plan standards.
    Response: As discussed above, under the rule, any decisions about
equipment and personnel deployment are coordinated at the local level
with the cognizant COTPs, Regional Response Teams, and Area Committees.
Additionally, the letter to the Governors of Washington and Oregon
stated that Coast Guard and EPA will continue to work in close
coordination with state and local governments, affected local
industries, Regional Response Teams and Area Committees to maintain a
level of equipment able to best protect all localities.
4. Regional Approach for Moving Response Assets
    Two comments suggested that the Coast Guard and EPA develop a
regional approach rather than one nationwide rule for moving response
assets. The comments encouraged developing regional strategies to
ensure sufficient coverage remains in those regions before moving oil
spill response assets outside of those regions. Another comment
specifically requested utilizing Regional Response Teams for such a
regional approach.
    Response: The Coast Guard and EPA agree that the decision to
actually move response assets is best made at the local and regional
level. In order to allow those local and regional decisions to be made,
however, this nationwide rule is necessary to temporarily suspend
certain regulatory response time requirements. As stated in the rule,
the Coast Guard and EPA coordinate and consult with Regional Response
Teams and Area Committees, which include State representatives, for
such decisions. Additionally, in a letter to the Governors of
Washington and Oregon, the Coast Guard and EPA specifically stated:
``If there were to be a scenario in which more response resources were
needed in the Gulf, we would work closely with [state and local
governments and affected local industries] and the Regional Response
Teams and Area Committees, to ensure that we do not deploy equipment or
personnel that would result in the loss of response capability below
worst case and maximum most probable discharge response time
requirements in the Pacific Northwest.''
5. Plan Holders Included in the Decision To Move Assets
    At least one comment requested that plan holders be included in any
discussion regarding movement of

response assets to the Gulf or any future Spill of National
Significance.
    Response: The rule only addresses relocating assets in response to
the Deepwater Horizon SONS. The Coast Guard and EPA agree that plan
holders should be included in discussions regarding movement of
response assets in response to the Deepwater Horizon SONS. That is why,
as stated in the rule, any such relocation of assets is done only
through coordination with the cognizant COTPs and Regional Response
Teams and Area Committees, which include oil spill response community
and plan holder representatives.
6. State Consultation
    One comment requested that Coast Guard and EPA formally consult
with state environmental agencies prior to approving the deployment of
additional equipment and personnel out of their region that would
result in the loss of response capability below the federal Maximum
Most Probable Discharge standards.
    Response: As stated in the rule, States are involved in any
decisions about equipment and personnel deployment. The Coast Guard and
EPA stated that we coordinate and consult with Regional Response Teams
and Area Committees, which include State representatives, for such
decisions. Additionally, in the letter to the Governors of Washington
and Oregon, the Coast Guard and EPA stated that we will continue to
work in close coordination with state and local governments and
affected local industries.
7. Other Federal Laws and State and Local Laws
    Several comments noted that the rule addresses only Coast Guard and
EPA requirements, but that plan holders are also covered by other
Federal regulatory requirements as well as State and local laws. One
comment suggested revising the rule to address other Federal
requirements as well as State and local requirements. Another comment
suggested creating a permanent rule to address all Federal and State
response standards for use in such emergency situations. This comment
suggested working with States and Congress for a legislatively
established emergency procedure for such situations.
    Response: The Coast Guard and EPA coordinated on the rule because
many oil spill response plans address both Coast Guard and EPA oil
spill response requirements. The rule was not meant to address all
Federal requirements or State requirements. In the rule, we
specifically stated that States are authorized to establish oil spill
response standards more stringent than Coast Guard and EPA, and Coast
Guard and EPA coordinate and consult with State representatives,
regarding implementation of the rule. The rule will expire on December
31, 2010. The Coast Guard and EPA are considering whether a permanent
rule addressing this issue is necessary, but would initiate a separate
rulemaking for any such permanent rule.
8. Tribal Implications
    The MTC disagreed with the finding in the rule that the rule does
not have tribal implications under EO 13175 because tribal marine
resources could be significantly jeopardized by an uncontained oil
spill due to the depletion of government and private oil spill response
assets in this region.
    Response: In a letter to the MTC dated August 24, 2010, (available
in the docket), the Coast Guard reaffirmed its determination that the
rule does not have any tribal implications because the rule does not
require the movement of any oil spill response resources away from
current locations. Additionally, the letter noted that the MTC has been
appointed to the Northwest Area Committee and will be part of any
decision on whether to relocate oil spill response resources away from
that Committee's area. EPA has also reaffirmed, through a letter to the
MTC dated October 25, 2010, its determination that the rule does not
have any tribal implications because the rule does not require the
movement of any oil spill response resources away from current
locations.
9. Plan Holder Input Into the Rule
    One commenter felt that plan holders did not have sufficient input
into the development of the rule.
    Response: The Coast Guard and EPA note that the rule was issued as
an emergency rulemaking in response to the exigent circumstances
presented by the Deepwater Horizon SONS. Plan holders were given an
opportunity to comment on the rule during the comment period. All
comments, materials and evidence received on the rule are discussed
above in this section.

B. Alternative Arrangements Under NEPA

    Coast Guard and DHS, with the assistance of EPA, consulted with CEQ
pursuant to NEPA regulations found in 40 CFR 1506.11 to develop
alternative NEPA arrangements for implementation of this rule. These
alternative arrangements, which take the place of an Environmental
Impact Statement, provide that Coast Guard and DHS will consider the
potential for significant impacts to the human environment from this
rule during implementation of the rule. The Alternative Arrangements
were posted to the Deepwater Horizon Web site (http://www.dhs.gov/xabout/laws/gc_1283521666674.shtm) on July 13, 2010, and remain
available to interested parties at this Web site. The Alternative
Arrangements are also available in the docket as indicated under
ADDRESSES above.
    Under the alternative arrangements, each COTP consults with the
Area Committee and pertinent Regional Response Teams to determine what
assets may be made available to address the SONS using the Area
Contingency Plans (ACP). Each ACP includes an annex containing a Fish
and Wildlife and Sensitive Environments Plan prepared in consultation
with the U.S. Fish and Wildlife Service and NOAA and other interested
natural resource management agencies and parties (including coastal
zone management agencies). The annex addresses fish and wildlife
resources and their habitat, and other areas the Area Committee
recommends be considered sensitive environments. The annex provides the
information and procedures to immediately and effectively respond to
discharges that may adversely affect fish and wildlife and their
habitat and sensitive environments. Determination of the needed
response resources considers local and regional factors such as
environmental risks, logistic limitations, and unique local or regional
circumstances.
    The determination by each COTP regarding available assets in the
area includes considering the development of equipment relocation and
backfilling (i.e., cascade plans) which will expand the interlocking
response back up of the various OSROs, and integrates military
resources which have previously been kept independent of supporting the
civilian OSROs. The COTP also considers available information on the
availability of current response resources, particularly in areas with
large vessel traffic lanes, heavy vessel traffic, oil refineries, oil
storage and pipeline facilities, seasonal risks associated with
weather, and trends associated with weather, currents and tides.

    Dated: December 2, 2010.
Robert Papp,
Admiral, U.S. Coast Guard, Commandant.
 Lisa P. Jackson,
 Administrator, U.S. Environmental Protection Agency.
[FR Doc. 2010-32018 Filed 12-20-10; 8:45 am]
BILLING CODE 9110-04-P; 6560-50-P


[Federal Register Volume 78, Number 128 (Wednesday, July 3, 2013)]
[Rules and Regulations]
[Pages 40020-40027]
[FR Doc No: 2013-15867]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2012-0520; FRL-9390-5]

Fenbuconazole; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
fenbuconazole in or on pepper. Dow AgroSciences LLC requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective July 3, 2013. Objections and
requests for hearings must be received on or before September 3, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0520, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Erin Malone, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

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

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

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0520 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
September 3, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0520, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
2F8034) by Dow AgroSciences LLC, 9330 Zionsville Road, Indianapolis,
Indiana 46268. The petition requested that 40 CFR 180.480 be amended by
modifying the tolerance for residues of the fungicide fenbuconazole,
alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)-1-
propanenitrile, and its metabolites RH-9129, cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, and
RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3 H-furanone, in or on pepper from 0.4 parts per
million (ppm) to 1.0 ppm. That document referenced a summary of the
petition prepared by Dow AgroSciences LLC, the registrant, which is
available in the docket, http://www.regulations.gov. A comment was
received on the notice of filing. EPA's response to this comment is
discussed in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue. . .
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for fenbuconazole including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with fenbuconazole
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. The main target organ of fenbuconazole is the liver.
Increased liver weight, hepatocellular hypertrophy, and clinical
chemistry changes were observed in the rat, dog,

and mouse following subchronic and chronic exposure. In the rat (but
not the dog or mouse), effects on the thyroid were also observed. A
mechanistic study demonstrated that these findings are secondary to
changes in liver metabolic enzyme activities, which result in
alterations to levels of circulating thyroid hormone due to increased
clearance via increased liver metabolism and, eventually, thyroid
hyperplasia. The rat is significantly more sensitive to these effects
than other species. Clear NOAELs and LOAELs were established for these
findings, and the endpoints selected for human health risk assessment
are protective of the thyroid effects. The endpoints are also
protective of potential thyroid perturbation to offspring, as the
developmental NOAELs were significantly higher than the NOAELs for
thyroid and liver effects in adults (e.g., chronic dietary endpoint
based on rat chronic/carcinogenicity NOAEL of 3 mg/kg/day vs. rat
developmental NOAEL of 30 mg/kg/day), and no increased quantitative
susceptibility was observed for thyroid and liver effects among the
offspring relative to the parental animals. Kidney and adrenal weights
were increased in dogs after chronic exposure. Although acute and
subchronic neurotoxicity have not been submitted, EPA concluded that
these studies are not required, taking into consideration the lack of
observed neurotoxic effects in the available studies for fenbuconazole
as well as many other triazole fungicides. There was no evidence of
increased quantitative or qualitative susceptibility to in utero or
post-natal exposure to fenbuconazole. Since the previous assessment,
new rabbit developmental toxicity and rat metabolism studies were
submitted; the findings of these studies are consistent with the data
EPA assessed previously and do not affect the overall characterization
of hazard or selection of doses and endpoints for risk assessment.
Fenbuconazole is classified as a ``Group C,'' or possible human
carcinogen, based on an increased incidence of liver tumors in male and
female mice. A cancer potency factor has been used to quantify
potential cancer risk associated with fenbuconazole uses.
    Specific information on the studies received and the nature of the
adverse effects caused by fenbuconazole 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 at http://www.regulations.gov in document ``Fenbuconazole: Human Health Risk
Assessment for an Increased Tolerance for Residues in Peppers and a
Label Amendment for the Enable 2F Product'' at page 14 in docket ID
number EPA-HQ-OPP-2012-0520.

B. Toxicological Points of Departure/Levels of Concern

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

 Table 1--Summary of Toxicological Doses and Endpoints for Fenbuconazole for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute dietary (Females 13-49       NOAEL = 30 mg/kg/day  Acute RfD = 0.3 mg/  Developmental rat study
 years of age).                    UFA = 10x...........   kg/day.             LOAEL = 75 mg/kg/day based on
                                   UFH = 10x...........  aPAD = 0.3mg/kg/day   increased resorptions,
                                   FQPA SF = 1x........                        postimplantation loss and
                                                                               decreased live fetuses per dam.
----------------------------------------------------------------------------------------------------------------
Acute dietary (General population  None................  None...............  Not selected
 including infants and children).                                             No appropriate single dose and
                                                                               endpoint could be identified for
                                                                               these population groups.
----------------------------------------------------------------------------------------------------------------
Chronic dietary (All populations)  NOAEL = 3 mg/kg/day.  Chronic RfD = 0.03   Combined chronic toxicity/
                                   UFA = 10x...........   mg/kg/day.           carcinogenicity--Rat
                                   UFH = 10x...........  cPAD = 0.03 mg/kg/   LOAEL = 30.6/43.1 (M/F) mg/kg/day
                                   FQPA SF = 1x........   day.                 based on decreased body weight
                                                                               gain, increased thyroid weight,
                                                                               and hispathological lesions in
                                                                               the liver and thyroid gland.
----------------------------------------------------------------------------------------------------------------

Cancer (Oral, dermal, inhalation)  Under the 1986 cancer classification scheme, fenbuconazole was classified as
                                    a Group C--Possible Human Carcinogen, with a low dose extrapolation model
                                    applied to the animal data for the quantification of human risk (Q1*). This
                                    classification was based on a statistically significant increase in combined
                                    hepatocellular adenomas and/or carcinomas by pair-wise comparison with
                                    concurrent controls, and significantly increasing trend in both the
                                    incidences of adenomas, and combined adenomas/carcinomas, in female mice.
                                    The upper bound estimate of unit risk, Q1* (mg/kg/day)-1 is 3.59 x -3 in
                                    human equivalents.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
  milligrams/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute,
  c = chronic). RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human
  (interspecies). UFH = potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to fenbuconazole, EPA considered exposure under the
petitioned-for tolerances as well as all existing fenbuconazole
tolerances in 40 CFR 180.480. For the acute, chronic, and cancer
dietary exposure assessments, EPA used food consumption information
from the United States Department of Agriculture's (USDA) National
Health and Nutrition Examination Survey/What We Eat In America (NHANES/
WWEIA) collected from 2003-2008. In addition, EPA assessed dietary
exposures from fenbuconazole in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
    Such effects were identified for fenbuconazole only for females age
13-49. As to residue levels in food, EPA used tolerance-level residues
and assumed 100% crop treated for all commodities in the acute dietary
exposure assessment.
    ii. Chronic exposure. As to residue levels in food, EPA used a
combination of tolerance-level residues and, for many foods, average
residue levels from crop field trials. One-hundred percent crop treated
was assumed for all commodities in the chronic dietary exposure
assessment.
    iii. Cancer. EPA determines whether quantitative cancer exposure
and risk assessments are appropriate for a food-use pesticide based on
the weight of the evidence from cancer studies and other relevant data.
If quantitative cancer risk assessment is appropriate, cancer risk may
be quantified using a linear or nonlinear approach. If sufficient
information on the carcinogenic mode of action is available, a
threshold or nonlinear approach is used and a cancer RfD is calculated
based on an earlier noncancer key event. If carcinogenic mode of action
data are not available, or if the mode of action data determines a
mutagenic mode of action, a default linear cancer slope factor approach
is utilized. Based on the data summarized in Unit III.A., EPA has
concluded that fenbuconazole should be classified as ``Possibly
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk.
    In its assessment of dietary cancer risk, EPA used the same residue
levels as described for the chronic assessment. EPA also assumed 100%
crop treated, except for the percent crop treated estimates described
in Unit III.C.1.iv., below.
    iv. Anticipated residue and percent crop treated (PCT) information.
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide residues that have been
measured in food. If EPA relies on such information, EPA must require
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after
the tolerance is established, modified, or left in effect,
demonstrating that the levels in food are not above the levels
anticipated. For the present action, EPA will issue such Data Call-Ins
as are required by FFDCA section 408(b)(2)(E) and authorized under
FFDCA section 408(f)(1). Data will be required to be submitted no later
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data
on the actual percent of food treated for assessing chronic dietary
risk only if:
     Condition a: The data used are reliable and provide a
valid basis to show what percentage of the food derived from such crop
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any
estimates used. To provide for the periodic evaluation of the estimate
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows for the
cancer assessment: Almonds: 5%; apples: 5%; apricots: 5%; blueberries:
55%; cherries: 15%; grapefruit: 40%; nectarines: 5%; oranges: 5%;
peaches: 15%; pecans: 10%; plums/prunes: 1%; sugar beets: 1%; tangelos:
10%; tangerines: 1%.
    In most cases, EPA uses available data from United States
Department of Agriculture/National Agricultural Statistics Service
(USDA/NASS), proprietary market surveys and the National Pesticide Use
Database for the chemical/crop combination for the most recent 6-7
years. EPA uses an average PCT for chronic dietary risk analysis. The
average PCT figure for each existing use is derived by combining
available public and private market survey data for that use, averaging
across all observations, and rounding to the nearest 5%, except for
those situations in which the average PCT is less than one. In those
cases, 1% is used as the average PCT and 2.5% is used as the maximum
PCT. EPA uses a maximum PCT for acute dietary risk analysis. The
maximum PCT figure is the highest observed maximum value reported
within the recent 6 years of available public and private market survey
data

for the existing use and rounded up to the nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit
III.C.1.iv. have been met. With respect to Condition a, PCT estimates
are derived from Federal and private market survey data, which are
reliable and have a valid basis. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. As to Conditions b and c, regional consumption
information and consumption information for significant subpopulations
are taken into account through EPA's computer-based model for
evaluating the exposure of significant subpopulations including several
regional groups. Use of this consumption information in EPA's risk
assessment process ensures that EPA's exposure estimate does not
understate exposure for any significant subpopulation group and allows
the Agency to be reasonably certain that no regional population is
exposed to residue levels higher than those estimated by the Agency.
Other than the data available through national food consumption
surveys, EPA does not have available reliable information on the
regional consumption of food to which fenbuconazole may be applied in a
particular area.
    2. Dietary exposure from drinking water. The Agency used screening-
level water exposure models in the dietary exposure analysis and risk
assessment for fenbuconazole in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of fenbuconazole. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling
System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-
GROW) models, the estimated drinking water concentrations (EDWCs) of
fenbuconazole for acute exposures are estimated to be 24.1 parts per
billion (ppb) for surface water and 0.031 ppb for ground water, for
chronic exposures for non-cancer assessments are estimated to be 16.5
ppb for surface water and 0.031 ppb for ground water, and for chronic
exposures for cancer assessments are estimated to be 11.7 ppb for
surface water and 0.031 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 24.1 ppb was used to
assess the contribution from drinking water. For chronic dietary risk
assessment, the water concentration of value 16.5 ppb was used to
assess the contribution from drinking water. For cancer dietary risk
assessment, the water concentration of value 11.7 ppb was used to
assess the contribution from 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). Fenbuconazole is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    Fenbuconazole is a member of the triazole-containing class of
pesticides. Although conazoles act similarly in fungi by inhibiting
ergosterol biosynthesis, there is not necessarily a relationship
between their pesticidal activity and their mechanism of toxicity in
mammals. Structural similarities do not constitute a common mechanism
of toxicity. Evidence is needed to establish that the chemicals operate
by the same, or essentially the same, sequence of major biochemical
events. In conazoles, however, a variable pattern of toxicological
responses is found: Some conazoles are hepatotoxic and
hepatocarcinogenic in mice, some induce thyroid tumors in rats, and
some induce developmental, reproductive, and neurological effects in
rodents. Furthermore, the conazoles produce a diverse range of
biochemical events including altered cholesterol levels, stress
responses, and altered DNA methylation. It is not clearly understood
whether these biochemical events are directly connected to their
toxicological outcomes. Thus, there is currently no evidence to
indicate that conazoles share common mechanisms of toxicity and EPA is
not following a cumulative risk approach based on a common mechanism of
toxicity for the conazoles. For information regarding EPA's procedures
for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.
    Fenbuconazole is a triazole-derived pesticide. This class of
compounds can form the common metabolite 1,2,4-triazole as well as the
common triazole conjugates (triazolylalanine, triazolylacetic acid, and
triazolylpyrivic acid). To support existing tolerances and to establish
new tolerances for triazole-derivative pesticides, including
fenbuconazole, EPA conducted human health risk assessments for exposure
to 1,2,4-triazole and the common triazole conjugates resulting from the
use of all current and pending uses of any triazole-derived fungicide.
The risk assessment is a highly conservative, screening-level
evaluation in terms of hazards associated with common metabolites
(e.g., use of a maximum combination of uncertainty factors) and
potential dietary and non-dietary exposures (i.e., high end estimates
of both dietary and non-dietary exposures). The assessment includes
evaluations of risks for various subgroups, including those comprised
of infants and children. The Agency's complete risk assessment is found
in the propiconazole reregistration docket at http://www.regulations.gov, docket identification (ID) number EPA-HQ-OPP-2005-
0497.
    Aggregate risk from exposure to the common triazole metabolites
were recently estimated by the Agency (1 May 2013) and found to be not
of concern. An updated dietary exposure and risk analysis for the
common triazole metabolites 1,2,4-triazole (T), triazolylalanine (TA),
triazolylacetic acid (TAA), and triazolylpyruvic acid (TP), reflecting
the revised tolerance for residues of fenbuconazole in/on pepper was
completed on May 21, 2013. Given that the updated dietary risk estimate
increased by less than 1% relative to the previous assessment, new
aggregate risk estimates were not made, and aggregate risk estimates
for the common triazole metabolites remain below the Agency's level of
concern. These documents may be found on http://www.regulations.gov by
searching for the following titles and docket numbers: ``Common
Triazole Metabolites: Updated Aggregate Human Health Risk Assessment to
Address The New Section 3 Registrations For Use of Prothioconazole on
Bushberry Crop Subgroup 13-07B, Low Growing Berry, Except Strawberry,
Crop Subgroup 13-07H, and Cucurbit Vegetables Crop Group 9; Use of
Flutriafol on Coffee; and Ipconazole on Crop Group 6'' (located in
docket ID number EPA-HQ-OPP-2012-0876) and ``Common Triazole
Metabolites: Updated Dietary (Food + Water) Exposure and Risk
Assessment to Address the Revised

Tolerance for Residues of Fenbuconazole in Peppers'' (docket ID number
EPA-HQ-OPP-2012-0520).

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the FQPA Safety
Factor (SF). In applying this provision, EPA either retains the default
value of 10X, or uses a different additional safety factor when
reliable data available to EPA support the choice of a different
factor.
    2. Prenatal and postnatal sensitivity. In the rat and rabbit
developmental toxicity studies and the 2-generation study in rats, all
effects in the pups occurred in the presence of maternal toxicity,
including changes in body weight and body weight gains in rats and
decreased food consumption and clinical signs in rabbits. Developmental
effects included increased post-implantation loss and decreased live
fetuses per dam in the rat developmental study; increased early
resorptions in the rabbit developmental study; and decreased mean pup
body weight, increased number of stillborn pups, decreased number of
total offspring delivered, and decreased viability index of pups in the
two generation study in rats. No increased qualitative or quantitative
susceptibility was observed in any of the studies. In the rat
developmental toxicity study, although a decrease in the number of live
fetuses per litter was observed at the LOAEL, this effect was due
largely to reduced implantation sites, which may reflect maternal
toxicity. Additionally, the increases in postimplantation loss and
early resorptions were marginal at the LOAEL. Therefore, the findings
in this study were not considered indicative of increased offspring
susceptibility. In the rabbit developmental study, developmental
effects were observed at a higher dose than maternal effects. In the
rat reproduction study, effects on pup viability were observed at a
dose that resulted in maternal mortality during delivery. There was no
evidence of neurotoxicity in any of the studies available in the
toxicology database. Therefore, a developmental neurotoxicity study is
not required.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1x. That decision is based on the following
findings:
    i. The toxicity database is complete, except for an immunotoxicity
study; however, due to the lack of any evidence of immunotoxicity based
upon the available studies, EPA does not believe that an immunotoxicity
study will result in a lower point-of-departure than those being relied
upon for the present risk assessments. Therefore, an uncertainty factor
is not required to account for the lack of this study.
    ii. There is no evidence of neurotoxicity in the available
database, and a developmental neurotoxicity study is not required.
    iii. There is no evidence that fenbuconazole 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 acute dietary exposure assessment is a screening-level
assessment, utilizing tolerance-level residues and assuming 100% crop
treated. The chronic dietary exposure assessment is slightly refined,
utilizing some tolerance-level residues and some average residue levels
from crop field trials and assuming 100% crop treated. The cancer
dietary exposure assessment is also slightly refined, utilizing the
same residue estimates as for the chronic assessment and some percent
crop treated estimates. EPA made conservative (protective) assumptions
in the ground water and surface water modeling used to assess exposure
to fenbuconazole in drinking water. There are no registered residential
uses for fenbuconazole. These assessments will not underestimate the
exposure and risks posed by fenbuconazole.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. The only population subgroup that is relevant for an
acute assessment is females of child-bearing age (i.e., females 13-49
years old). The acute risk estimate that results from this analysis is
2.9% of the acute population adjusted dose (aPAD) at the 95th
percentile of exposure. This risk estimate is considerably lower than
EPA's level of concern (100% of the aPAD).
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
fenbuconazole from food and water will utilize 6.7% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for fenbuconazole.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level). For
fenbuconazole, there are no residential uses and therefore a short-term
aggregate risk assessment was not needed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). There are no residential uses for fenbuconazole at this time,
therefore an intermediate-term risk assessment was not needed.
    5. Aggregate cancer risk for U.S. population. Fenbuconazole is
classified as a Group C (possible human) carcinogen under the Agency's
1986 Cancer Guidelines, based on increased incidences of liver tumors
in male and female mice and thyroid tumors in male rats. Using the
conservative exposure assumptions described in this unit for cancer
risk from chronic exposure and an upper bound estimate of unit risk
(Q1*) of 3.59 x 10-3 (mg/kg/day)-1,
EPA has derived a cancer risk estimate of 2.2 x 10-6 from
dietary exposure to fenbuconazole.
    EPA generally considers cancer risks (expressed as the probability
of an increased cancer case) in the range of 1 in 1 million (or 1 x
10-6) or less to be negligible. The precision which can be
assumed for cancer risk estimates is best described by rounding to the
nearest integral order of magnitude on the logarithmic scale; for
example, risks falling between 3 x 10-7 and 3 x
10-6 are expressed as risks in the range of 10-6.
Considering the precision with

which cancer hazard can be estimated, the conservativeness of low-dose
linear extrapolation, and the rounding procedure described in this
unit, cancer risk should generally not be assumed to exceed the
benchmark level of concern of the range of 10-6 until the
calculated risk exceeds approximately 3 x 10-6. This is
particularly the case where some conservatism is maintained in the
exposure assessment. Although the fenbuconazole exposure risk
assessment is somewhat refined, it retains significant conservatism in
that the analysis relies on field trial data and assumes 100% crop
treated for many commodities. Accordingly, EPA has concluded the
aggregate cancer risk for all existing fenbuconazole uses and the uses
associated with the tolerances established in this action fall within
the range of 1 x 10-6 and are thus negligible.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population or to infants and children from aggregate
exposure to fenbuconazole residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (GC/NPD method, TR 34-940-47 and
TR34-90-47R) is available to enforce the tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has established an MRL for fenbuconazole in or on pepper
at 0.6 ppm. This MRL is different than the tolerance established for
fenbuconazole in the United States. The Codex MRL for pepper was most
likely established before the Enable[supreg] 2F formulation was
proposed for use on peppers and includes only residues of the parent
compound. This new formulation has higher residues values ranging up to
0.7 ppm, and the U.S. tolerance includes the two lactone metabolites.
Harmonization with the 0.6 ppm tolerance is not feasible given the
proposed new use pattern/formulation and the observed residue levels.

C. Response to Comments

    EPA received a comment to the notice of filing which said that
residue levels of fenbuconazole should not be raised. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that pesticides should be banned on agricultural
corps. However, the existing legal framework provided by section 408 of
the Federal Food, Drug, and Cosmetic Act (FFDCA) states that tolerances
may be set when persons seeking such tolerances or exemptions have
demonstrated that the pesticide meets the safety standard imposed by
that statute. This citizen's comment appears to be directed at the
underlying statute and not EPA's implementation of it; the citizen has
made no contention that EPA has acted in violation of the statutory
framework.

V. Conclusion

    Therefore, tolerances are modified to establish residues of
fenbuconazole in or on pepper at 1.0 ppm. Consistent with the petition
and EPA's policy for clarifying its tolerance expressions, EPA is
revising the tolerance expression for fenbuconazole to clarify that the
tolerance includes metabolites and degradates of fenbuconazole and that
compliance with the tolerance levels specified in the table is to be
determined by measuring only the sum of fenbuconazole, alpha-[2-(4-
chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-1,2,4-triazole)-1-
propanenitrile, and its metabolites RH-;9129, cis-5-(4-chlorophenyl)-
dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, and
RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-
triazole-1-ylmethyl)-2-3 H-furanone, calculated as the stoichiometric
equivalent of fenbuconazole,

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate

as described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: June 21, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.480 revise paragraph (a) introductory text and revise
the entry ``Pepper'' in the table in paragraph (a) to read as follows:

Sec.  180.480  Fenbuconazole; tolerances for residues.

    (a) Tolerances are established for residues of the fungicide
fenbuconazole, including its metabolites and degradates, in or on the
commodities in the table below. Compliance with the tolerance levels
specified below is to be determined by measuring only the sum of
fenbuconazole, alpha-[2-(4-chlorophenyl)-ethyl]-alpha-phenyl-3-(1H-
1,2,4-triazole)-1-propanenitrile, and its metabolites RH-9129, cis-5-
(4-chlorophenyl)-dihydro-3-phenyl-3-(1H-1,2,4-triazole-1-ylmethyl)-2-3
H-furanone, and RH-9130, trans-5-(4-chlorophenyl)-dihydro-3-phenyl-3-
(1H-1,2,4-triazole-1-ylmethyl)-2-3 H-furanone, calculated as the
stoichiometric equivalent of fenbuconazole, in or on the following
agricultural commodities.

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Pepper..................................................             1.0

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

* * * * *
[FR Doc. 2013-15867 Filed 7-2-13; 8:45 am]
BILLING CODE 6560-50-P