[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Rules and Regulations]
[Pages 72223-72226]
[FR Doc No: 2012-29248]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0202; FRL-9371-6]

Clodinafop-Propargyl; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation reduces the established tolerance for residues
of clodinafop-propargyl in or on wheat, grain. Syngenta Crop
Protection, LLC requested this tolerance change under the Federal Food,
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective December 5, 2012. Objections and
requests for hearings must be received on or before February 4, 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-2012-0202, 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: Mindy Ondish, 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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the
OCSPP test guidelines referenced in this document electronically,
please go to http://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.''

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-2012-0202 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
February 4, 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-2012-0202, 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 Confidential Business
Information (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 October 17, 2012 (77 FR 63782) (FRL-
9366-2), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
1F7955) by Syngenta Crop Protection, LLC, P.O. Box 18300, Greensboro,
NC 27419-8300. The petition requested that 40 CFR 180.559 be amended by
lowering the established tolerance for residues of the herbicide
clodinafop-propargyl in or on wheat, grain from 0.1 to 0.02 parts per
million (ppm). That document referenced a summary of the petition
prepared by Syngenta Crop Protection, LLC, the registrant, which is
available in the docket, http://www.regulations.gov. Comments were
received on the notice of filing. EPA's response to these comments is
discussed in Unit IV.C. Finally, EPA is revising the tolerance

expression for the reasons explained in Unit IV.D.

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 clodinafop-propargyl including
exposure resulting from the tolerance established by this action. EPA's
assessment of exposures and risks associated with clodinafop-propargyl
follows.
    In the Federal Register of June 22, 2000 (65 FR 38765) (FRL-6590-
7), EPA published a final rule establishing tolerances for combined
residues of the herbicide clodinafop-propargyl and its acid metabolite
in or on wheat (forage, grain, hay, and straw) based upon EPA's
conclusion that aggregate exposure to clodinafop-propargyl is safe for
the general population, including infants and children. Since 2000,
there have been no additional tolerance actions for clodinafop-
propargyl.
    This action decreases the established tolerance for residues of
clodinafop-propargyl in or on the commodity wheat, grain from 0.1 to
0.02 ppm, based upon a change to an enforcement method (Method MS 247)
with a lower limit of quantitation (LOQ) on wheat grain than the
current methods. Since an established tolerance is being reduced, which
is expected to have no significant exposure effect, no new dietary
exposure assessment, drinking water exposure assessment, or non-dietary
exposure assessment was conducted.
    Except as supplemented by the information described in this unit,
EPA is relying on the safety finding in the 2000 rulemaking and the
risk assessment underlying that action in amending the tolerance for
wheat grain. Further information regarding the safety finding for the
last rulemaking can be found in the Federal Register of June 22, 2000,
at http://www.epa.gov/fedrgstr/EPA-PEST/2000/June/Day-22/p15715.htm.
Although significant new data have been received since the 2000
rulemaking, as discussed in this unit, these data do not indicate that
risk from exposure to clodinafop-propargyl were understated. To the
contrary, these new data suggest that EPA's prior risk assessment
overstated clodinafop-propargyl risks. Further information about EPA's
risk assessment and determination of safety for this action can be
found at http://www.regulations.gov in document ``Clodinafop-propargyl.
Human Health Risk Assessment for Clodinafop-propargyl to Reduce the
Established Tolerance on Wheat Grain'' in docket ID number EPA-HQ-OPP-
2012-0202.
    For the 2000 rulemaking, the toxicity database for clodinafop-
propargyl was considered incomplete. Acute neurotoxicity, subchronic
neurotoxicity, developmental neurotoxicity, and in vitro cytogenetic
studies were required. The absence of these studies, along with
quantitative and qualitative evidence of increased susceptibility, and
evidence of potential endocrine disruption, led EPA to retain an
additional safety factor for the protection of infants and children as
provided by FFDCA section 408(b)(2)(C) (i.e., 10X for acute risk for
females 13+ and chronic risk; 3X for acute risk for infants and
children). With the exception of the cytogenetic studies, the required
studies have since been submitted and found acceptable. Studies were
submitted which removed mutagenicity concerns and thus the cytogenetic
studies were no longer required.
    In all likelihood, the submission of these data will lead EPA to
remove the additional safety factor for the protection of infants and
children when it formally revises the clodinafop-propargyl risk
assessment. The absence of these data was the primary reason for
retaining that additional factor. Currently, there is a data gap for an
immunotoxicity study. In 2007 changes to 40 CFR part 158 imposed new
data requirements for immunotoxicity testing (OPPTS Guideline 870.7800)
for pesticide registration. This study has not been submitted for
clodinafop-propargyl. The absence of this study is unlikely to result
in retention of an additional safety factor. EPA has only retained an
additional safety factor when there is a data gap for immunotoxicity
where the database shows clear evidence of immunotoxicity and
immunotoxic effects were seen at the LOAEL that defined the point of
departure (POD). For clodinafop-propargyl, there is evidence in the
current toxicological database that clodinafop-propargyl may perturb
immune function but this evidence is not strong and it did not affect
the choice of the POD. In the subchronic oral toxicity study in rats,
treatment-related effects were observed (37% decrease in thymus weight
and increased thymic atrophy). Thymus effects were observed only in
males at the highest treatment-dose (71 mg/kg/day), and were fully
reversed after a 4-week recovery period. No thymus effects were
observed in the chronic toxicity/carcinogenicity study in rats. No
other indicators of structural immunotoxicity were observed in the
current database. While an immunotoxicity study is required to complete
the database, the absence of this study is not expected to alter the
aRfD or cRfD for clodinafop-propargyl. Hence, by relying on the 2000
risk assessment and the additional safety factors retained in that
assessment, EPA has taken a conservative approach that is likely to
overstate the estimated risk of clodinafop-propargyl.
    The EPA has determined that the results of the neurotoxicity
studies adequately elucidate the hazard but do not affect EPA's
derivation of clodinafop-propargyl's acute reference dose (aRfD) or
chronic reference dose (cRfD). The NOAELs for adverse effects seen in
the neurotoxicity studies are well above the NOAELs in the studies used
as PODs. Thus, the PODs used in the risk assessment for the 2000
rulemaking for clodinafop-propargyl, as well as the aRfD and the cRfD
derived from those PODs, are protective of all effects, including
neurotoxicity, observed in the neurotoxicity studies.
    Previously, EPA considered clodinafop-propargyl as likely to be
carcinogenic to humans based on increased incidences of prostate tumors
in male rats, ovarian adenomas in female rats, liver tumors in male and
female mice, and blood vessel tumors in female mice and estimated
cancer risk using a linear (non-threshold) approach. Since that time,
additional data have been submitted, including a re-evaluation of the
proliferative lesions in the rat ovary and prostate as well as

mode of action data for mouse liver tumors. In 2006, EPA revised its
cancer determination on clodinafop-propargyl concluding that the
evidence was no greater than suggestive of carcinogenic potential and
thus did not support the finding that clodinafop-propargyl was likely
to be carcinogenic to humans. That conclusion was based on the
following:
    1. Prostate tumors (driven mainly by adenomas) were seen in one sex
(male) of one species (rat) at the high dose only.
    2. There is no mutagenicity concern for clodinafop-propargyl.
    3. The weight-of-evidence supports activation of peroxisome
proliferator-activated receptor alpha (PPAR'') as the mode of action
for clodinafop-induced hepatocarcinogenesis in mice. While the PPAR
mode of action for liver tumors in mice is theoretically plausible in
humans, hepatocarcinogenesis by this mode of action is quantitatively
implausible and unlikely to take place in humans based on quantitative
species differences in PPAR'' activation and toxicokinetics.
    4. Ovarian tumors in the rat and vascular tumors in the mouse were
not considered to be treatment-related in the Second Report of the
Cancer Assessment Review Committee.
    Given this limited evidence of carcinogenic effects in animals or
effects unlikely to be relevant to humans, the use of a linear (non-
threshold) approach for assessing cancer risk is no longer appropriate.
Instead, EPA has determined that the chronic threshold-based risk
assessment (i.e., the cRfD approach) will be protective of any cancer
risk.
    Based upon the 2000 rulemaking and the other information discussed
in this unit, EPA concludes that there is a reasonable certainty that
no harm will result to the general population and to infants and
children from aggregate exposure to clodinafop residues. EPA relies
upon those risk assessments and the findings made in the Federal
Register document in support of this action.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method using high-performance liquid chromatography
with tandem mass spectrometry detection (LC/MS/MS), Enviro-Test
Laboratories Report No. MS 247 (Method MS 247) was submitted in support
of reducing the tolerance for wheat grain.
    This LC/MS/MS method has a lower LOQ than the current HPLC-UV
methods (REM 138.01 for clodinafop-propargyl and REM 138.10 for
clodinafop) for the determination of residues of clodinafop-propargyl
(CGA-184927) and its metabolite clodinafop (CGA-193469) in or on wheat
commodities. Method MS 247 was adequately validated using fortified
samples of wheat grain, forage, and straw.
    The current enforcement methods (REM 138.01 for clodinafop-
propargyl and REM 138.10 for clodinafop) can serve as confirmatory
methods for Method MS 247 on wheat grain since they use a different
detection system. Therefore, the LC/MS/MS Method MS 247 is adequate as
an enforcement analytical method for determination of residues of
clodinafop-propargyl and its metabolite clodinafop in wheat grain at
0.02 ppm (0.01 ppm for each analyte). The methods referenced in this
unit may be requested from: Chief, Analytical Chemistry Branch,
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

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

C. Response to Comments

    EPA received an anonymous comment in response to the Notice of
Filing that objected to the proposed tolerance petition. The commenter
stated that the objection was to the ``Syngenta application to increase
[the tolerance] from .01 to .02 ppm''. Because this action is to
decrease the tolerance from 0.1 to 0.02 ppm, it is assumed that the
commenter misinterpreted the proposed petition and would have no
objections otherwise. The commenter made additional comments proposing
to eliminate tolerances and pesticides altogether. The Agency
understands the commenter's concerns and recognizes that some
individuals believe that certain pesticide chemicals should not be
permitted in our food. 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. When new or amended tolerances are
requested for residues of a pesticide in food or feed, the Agency, as
is required by section 408 of the FFDCA, estimates the risk of the
potential exposure to these residues. The Agency has concluded after
this assessment that there is a reasonable certainty that no harm will
result from aggregate human exposure to clodinafop-propargyl.
    EPA received a second anonymous comment in response to the Notice
of Filing which urged that regulations in general be stopped because
they are killing small businesses. This comment is considered
irrelevant to this action because the safety standard for approving
tolerances under section 408 of FFDCA focuses on potential harm to
human health and does not permit consideration of effects on any type
of businesses.

D. Revisions to Petitioned-for Tolerances

    Finally, the EPA is revising the tolerance expression to:
    1. Clarify that, as provided in FFDCA section 408(a)(3), the
tolerance covers metabolites and degradates of clodinafop-propargyl not
specifically mentioned; and
    2. Clarify that compliance with the specified tolerance levels is
to be determined by measuring only the specific compounds mentioned in
the tolerance expression.

 V. Conclusion

    Therefore, the established tolerance for residues of clodinafop-
propargyl in or on wheat, grain is reduced from 0.1 to 0.02 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and

Budget (OMB) has exempted these types of actions from review under
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993). Because this final rule has been exempted
from review under Executive Order 12866, this final rule is not subject
to Executive Order 13211, entitled ``Actions Concerning Regulations
That Significantly Affect Energy Supply, Distribution, or Use'' (66 FR
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of
Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: November 27, 2012.
G. Jeffrey Herndon,
Acting 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.  180.559, in paragraph (a), revise the introductory text;
and in the table, revise the entry for ``Wheat, grain'' to read as
follows:

Sec.  180.559  Clodinafop-propargyl; tolerances for residues.

    (a) General. Tolerances are established for clodinafop-propargyl,
including its metabolites and degradates, in or on the commodities in
the following table. Compliance with the tolerance levels specified in
the following table is to be determined by measuring only clodinafop-
propargyl [(2R)-2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]propanoic acid, 2-propynyl ester] and its
metabolite clodinafop [(2R)-2-[4-[(5-chloro-3-fluoro-2-
pyridinyl)oxy]phenoxy]propanoic acid].

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

                                * * * * *
Wheat, grain............................................            0.02

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

* * * * *
[FR Doc. 2012-29248 Filed 12-4-12; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 242 (Friday, December 16, 2016)]
[Proposed Rules]
[Pages 91086-91088]
[FR Doc No: 2016-30342]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0988]
RIN 1625-AA09

Drawbridge Operation Regulation; Detroit River (Trenton Channel),
Grosse Ile, MI

AGENCY:  Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to add permanent winter hours to the
operating schedule of the Grosse Ile Toll Bridge (Bridge Road) at mile
8.8, over Trenton Channel at Grosse Ile, MI. A review of the current
regulation was requested by the Grosse Ile Bridge Company, the owner of
the Grosse Ile Toll Bridge (Bridge Road).

DATES: Comments and related material must reach the Coast Guard on or
before: January 17, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2016-0988 using Federal eRulemaking Portal at http://www.regulations.gov.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Mr. Lee D. Soule, Bridge Management Specialist,
Ninth Coast Guard District; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
E.O. Executive order
FR Federal Register
NEPA National Environmental Policy Act of 1969
NPRM Notice of proposed rulemaking
RFA Regulatory Flexibility Act of 1980
SNPRM Supplemental notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose and Legal Basis

    This proposed rule was requested by the Grosse Ile Bridge Company,
the owner of the Grosse Ile Toll Bridge (Bridge Road) to align
drawbridge operating schedules with the Wayne County Highway Bridge
(Grosse Ile Parkway) Bridge at mile 5.6, at Grosse Ile. The Grosse Ile
Highway Bridge is authorized to remove drawtenders and open the
drawbridge if at least 12-hours advance notice is provided from
December 15 through March 15 each year. This proposed rule will make
the current regulation easier to follow for the mariners that use the
river system. The Grosse Ile Toll Bridge (Bridge Road) was not granted
permanent winter hours in the past due to regular commercial traffic
that required bridge openings during the winter months. Over the past
two winter seasons the commercial traffic has been reduced
significantly and waterway use through this drawbridge is equivalent to
the volume and type of traffic that passes through the Wayne County
Highway (Grosse Ile Parkway) Bridge that has had permanent winter hours
for approximately 10 years. Mariners will still be able to request
bridge openings with advance notice during times of light traffic
volume on the river, which is due to ice formation on the Detroit River
that typically prevents most vessel traffic from navigation in the
channel from December 15 through March 15 each year. Additionally,
Commander, Ninth Coast Guard District has granted annual authorization
to the owner/operator of the Grosse Ile Toll Bridge to assume the same
schedule during the past 10 years under authority granted in 33 CFR
117.35.

III. Discussion of Proposed Rule

    Currently, the regulation for Grosse Ile drawbridges (33 CFR
117.631) includes the operating schedule for the Grosse Ile Toll Bridge
(Bridge Road) and the Wayne County Highway Bridge (Grosse Ile Parkway)
Bridge at mile 5.6, both at Grosse Ile, MI. The purpose of this
proposed rule is to establish the same permanent 12-hours advance
notice for both bridges on the waterway from December 15 through March
15 each year. The only change in this proposed rule is to allow a
permanent requirement for 12-hours advance notice during the winter
months when ice typically prevents recreational navigation in the
channel. At all times both bridges will be required to open as soon as
possible for public vessels of the United States, State or local
government vessels used for public safety, and vessels in distress.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on these statutes and executive orders and discuss First
Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. This NPRM has not been designated
a ``significant regulatory action,'' under executive order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget.
    This regulatory action determination is based on the ability that
vessels can still transit the bridge given advanced notice during times
when vessel traffic is at its lowest. The proposed winter drawbridge
schedule for the Grosse Ile Toll Bridge (Bridge Street) would be the
same as the Wayne County Highway Bridge (Grosse Ile Parkway) Bridge.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities. While some owners or operators of
vessels intending to transit the bridge may be small entities, for the
reasons stated in section IV.A above this proposed rule standardizes
drawbridge schedules for both drawbridges on the waterway and would not
have a significant economic impact on any vessel owner or operator
because the bridges will open with advance notice during low traffic
times on the waterway, or when ice conditions hinder normal navigation.

    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section, above. The Coast Guard will not retaliate against small
entities that question or complain about this proposed rule or any
policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Government

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in executive order
13132.
    Also, this proposed rule does not have tribal implications under
executive order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, 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. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule will not
result in such an expenditure, we do discuss the effects of this
proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment. This proposed rule simply
promulgates the operating regulations or procedures for drawbridges.
Normally such actions are categorically excluded from further review,
under figure 2-1, paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this notice, and all public comments, are in
our online docket at http://www.regulations.gov and can be viewed by
following that Web site's instructions. Additionally, if you go to the
online docket and sign up for email alerts, you will be notified when
comments are posted or a final rule is published.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to revise 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. In Sec.  117.631, revise paragraph (a) to read as follows:

Sec.  117.631   Detroit River (Trenton Channel).

    (a) The draw of the Grosse Ile Toll Bridge (Bridge Road), mile 8.8,
at Grosse Ile, shall operate as follows:
    (1) From March 16 through December 14--
    (i) Between the hours of 7 a.m. and 11 p.m., seven days a week and
holidays, the draw need open only from three minutes before to three
minutes after the hour and half-hour for pleasure craft; for commercial
vessels, during this period of time, the draw shall open on signal as
soon as possible.
    (ii) Between the hours of 11 p.m. and 7 a.m., the draw shall open
on signal for pleasure craft and commercial vessels.
    (2) From December 15 through March 15, no bridge tenders are
required to be on duty at the bridge and the bridge shall open on
signal if at least a twelve-hour advance notice is given.
* * * * *

    Dated: November 30, 2016.
J.E. Ryan,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2016-30342 Filed 12-15-16; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 17080-17082]
[FR Doc No: 2023-05754]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2022-0047]

Qualification of Drivers; Exemption Applications; Epilepsy and
Seizure Disorders

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), Department
of Transportation (DOT).

ACTION: Notice of final disposition.

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

SUMMARY: FMCSA announces its decision to exempt 15 individuals from the
requirement in the Federal Motor Carrier Safety Regulations (FMCSRs)
that interstate commercial motor vehicle (CMV) drivers have ``no
established medical history or clinical diagnosis of epilepsy or any
other condition which is likely to cause loss of consciousness or any
loss of ability to control a CMV.'' The exemptions enable these
individuals who have had one or more seizures and are taking anti-
seizure medication to operate CMVs in interstate commerce.

DATES: The exemptions were applicable on February 28, 2023. The
exemptions expire on February 28, 2023.

FOR FURTHER INFORMATION CONTACT: Ms. Christine A. Hydock, Chief,
Medical Programs Division, FMCSA, DOT, 1200 New Jersey Avenue SE, Room
W64-224, Washington, DC 20590-0001,<PHONE_NUMBER>,
[email protected]. Office hours are from 8:30 a.m. to 5 p.m. ET
Monday through Friday, except Federal holidays. If you have questions
regarding viewing or submitting material to the docket, contact Dockets
Operations,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Comments

    To view comments go to www.regulations.gov. Insert the docket
number, (FMCSA-2022-0047) in the keyword box and click ``Search.''
Next, sort the results by ``Posted (Newer-Older),'' choose the first
notice listed, and click ``Browse Comments.'' If you do not have access
to the internet, you may view the docket online by visiting Dockets
Operations in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET Monday through Friday, except Federal holidays. To
be sure someone is there to help you, please call<PHONE_NUMBER> or
(202) 366-9826 before visiting Dockets Operations.

B. Privacy Act

    In accordance with 49 U.S.C. 31315(b)(6), DOT solicits comments
from the public on the exemption requests. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov. As described in the system of records
notice DOT/ALL 14 (Federal Docket Management System), which can be
reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices, the comments are searchable by the name of
the submitter.

II. Background

    On January 24, 2023, FMCSA published a notice announcing receipt of
applications from 15 individuals requesting an exemption from the
epilepsy and seizure disorders prohibition in 49 CFR 391.41(b)(8) and
requested comments from the public (88 FR 4286). The public comment
period ended on February 23, 2023, and no comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting exemptions to these individuals would likely
achieve a level of safety that is equivalent to, or greater than, the
level that would be achieved by complying with Sec.  391.41(b)(8).
    The physical qualification standard for drivers regarding epilepsy
found in Sec.  391.41(b)(8) states that a person is physically
qualified to drive a CMV if that person has no established medical
history or clinical diagnosis of epilepsy or any other condition which
is likely to cause the loss of consciousness or any loss of ability to
control a CMV.
    In addition to the regulations, FMCSA has published advisory
criteria \1\ to assist medical examiners (MEs) in determining whether
drivers with certain medical conditions are qualified to operate a CMV
in interstate commerce.
---------------------------------------------------------------------------

    \1\ These criteria may be found in APPENDIX A TO PART 391--
MEDICAL ADVISORY CRITERIA, section H. Epilepsy: Sec.  391.41(b)(8),
paragraphs 3, 4, and 5, which is available on the internet at
https://www.gpo.gov/fdsys/pkg/CFR-2015-title49-vol5/pdf/CFR-2015-title49-vol5-part391-appA.pdf.
---------------------------------------------------------------------------

III. Discussion of Comments

    FMCSA received no comments in this proceeding.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statutes allow the Agency to renew exemptions at the end
of the 5-year period. However, FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.
    The Agency's decision regarding these exemption applications is
based on the 2007 recommendations of the Agency's Medical Expert Panel.
The Agency conducted an individualized assessment of each applicant's
medical information, including the root cause of the respective
seizure(s) and medical information about the applicant's seizure
history, the length of time that has elapsed since the individual's
last seizure, the stability of each individual's treatment regimen and
the duration of time on or off of anti-seizure medication. In addition,
the Agency reviewed the treating clinician's medical opinion related to
the ability of the driver to safely operate a CMV with a history of
seizure and each applicant's driving record found in the commercial
driver's license Information System for commercial driver's license
(CDL) holders, and interstate and intrastate inspections recorded in
the Motor Carrier Management Information System. For non-CDL holders,
the Agency reviewed the driving records from the State Driver's
Licensing Agency. A summary of each applicant's seizure history was
discussed in the January 24, 2023, Federal Register notice (88 FR 4286)
and will not be repeated in this notice.
    These 15 applicants have been seizure-free over a range of 33 years
while taking anti-seizure medication and maintained a stable medication
treatment regimen for the last 2 years. In each case, the applicant's
treating physician verified his or her seizure history and supports the
ability to drive commercially.
    The Agency acknowledges the potential consequences of a driver
experiencing a seizure while operating a CMV. However, the Agency
believes the drivers granted this exemption have demonstrated that they
are unlikely to have a seizure and their medical condition does not
pose a risk to public safety.
    Consequently, FMCSA finds further that in each case exempting these
applicants from the epilepsy and seizure disorder prohibition in Sec.
391.41(b)(8) would likely achieve a level of safety equal to that
existing without the exemption, consistent with the applicable standard
in 49 U.S.C. 31315(b)(1).

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and include the following: (1)
each driver must remain seizure-free and maintain a stable treatment
during the 2-year exemption period; (2) each driver must submit annual
reports from their treating physicians attesting to the stability of
treatment and that the driver has remained seizure-free; (3) each
driver must undergo an annual medical examination by a certified ME, as
defined by Sec.  390.5T; and (4) each driver must provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy of their driver's
qualification file if they are self-employed. The driver must also have
a copy of the exemption when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

VI. Preemption

    During the period the exemption is in effect, no State shall
enforce any law or regulation that conflicts with this exemption with
respect to a person operating under the exemption.

VII. Conclusion

    Based upon its evaluation of the 15 exemption applications, FMCSA
exempts the following drivers from the epilepsy and seizure disorder
prohibition in Sec.  391.41(b)(8), subject to the requirements cited
above:

Andrew Briggs (WI)
Joel Clapper (MI)
Trent Clark (PA)
John Girdley (KY)
Larry Kirby (MO)
Matthew Lynch (PA)
Edward Malicki (NY)
Jared Meyers (MS)
James Niemoller (MD)
Joshua Pattyn (OR)
Joe W. Porath (ID)
Jon Rollins (OH)
Garrett Sager (IA)
Colin Trummer (OH)
Shawn Vanliew (MN)

    In accordance with 49 U.S.C. 31315(b), each exemption will be valid
for 2 years from the effective date unless revoked earlier by FMCSA.
The exemption will be revoked if the following occurs: (1) the person
fails to comply with the terms and conditions of the exemption; (2) the
exemption has resulted in a lower level of safety than was maintained
prior to being granted; or (3) continuation of the exemption would not
be consistent with the goals

and objectives of 49 U.S.C. 31136, 49 U.S.C. chapter 313, or the
FMCSRs.

Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2023-05754 Filed 3-20-23; 8:45 am]
BILLING CODE 4910-EX-P


DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

April 26 – 29, 2010

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2010-0125

The Hamilton Crowne Plaza Hotel

The Hamilton Ballroom

1001 14th Street, NW

Washington, DC 20005

202-682-0111

Reevaluation of the Human Health Effects of Atrazine: Review of
Experimental Animal and In Vitro Studies and Drinking Water Monitoring
Frequency

Please note that all times are approximate (see note at end of Agenda).

Monday, April 26,  2010

1:00   P.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

1:05   P.M. 	Introduction and Identification of Panel Members –
Kenneth Portier, Ph.D., FIFRA Scientific Advisory Panel Session Chair

1:15   P.M.	Welcome and Opening Remarks – Steven Bradbury, Ph.D.,
Acting Director, Office of Pesticide Programs, EPA

1:25   P.M.	Welcome and Introductions – Tina Levine, Ph.D., Director,
Health Effects Division, Office of Pesticide Programs, EPA

1:30   P.M.	EPA Presentation – Experimental Animal and In Vivo Studies

3:00   P.M.	Break

3:15   P.M.	Experimental Animal and In Vivo Studies Presentation
Continued

4:30   P.M.	EPA Presentation – Drinking Water Monitoring Frequency

5:30   P.M.	Adjourn

DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

April 26 – 29, 2010

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2010-0125

The Hamilton Crowne Plaza Hotel

The Hamilton Ballroom

1001 14th Street, NW

Washington, DC 20005

202-682-0111

Reevaluation of the Human Health Effects of Atrazine: Review of
Experimental Animal and In Vitro Studies and Drinking Water Monitoring
Frequency

Please note that all times are approximate (see note at end of Agenda).

Tuesday, April 27,  2010

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members – Kenneth
Portier, Ph.D., FIFRA Scientific Advisory Panel Session Chair

8:45 A.M.	Follow-up from Previous Day’s Presentations

9:15 A.M.	Public Comments

10:30 A.M.	Break

10:45 A.M.	Public Comments

12:15 P.M.	Lunch Break

1:30 P.M.	Charge to Panel – Question 1

In Vivo & In Vitro Experimental Toxicology in Mammals

In 2003, the human health risk assessment was based on a mode of action
in which exposure to atrazine leads to a reduced release of gonadotropin
releasing hormone (GnRH) from the hypothalamus thereby lessening the
afternoon pituitary luteinizing hormone (LH) surge in female Sprague
Dawley rats.  As a result, the estrus cycle lengthens.  This, in turn,
leads to increased estrogen levels and an increased incidence of mammary
tumors in female Sprague Dawley rats.  EPA determined that atrazine’s
cancer mode of action (i.e., premature reproductive aging) in the
Sprague-Dawley rat is not likely to be operative in humans (a conclusion
consistent with the SAP recommendation in 2000).  The Agency will be
evaluating the cancer classification further as the experimental
toxicology data are integrated with the epidemiology literature; new
experimental toxicology studies (Section 3.6 of the draft issue paper)
do not suggest a change to the Agency’s previous conclusion that
atrazine is “not likely to be carcinogenic to humans.”

Although the cancer mode of action may not be operative in humans, it is
not unreasonable to assume that atrazine might cause adverse effects on
hypothalamic-pituitary function in humans.  Thus, the same endocrine
perturbations that induce tumors in rats may play a role in at least
some reproductive/developmental effects (not associated with
reproductive aging) that may be relevant to humans.  Accordingly, the
Agency identified disruption of estrous cyclicity and delays in puberty
onset (males and females) occurring as a consequence of disruptions to
the hypothalamic-pituitary-gonadal (HPG) axis as the critical endpoints
of concern (Sections 2.0 & 3.2 of the draft issue paper).

The Agency continues to believe that this disruption of the HPG axis is
critical to affecting

 estrous cyclicity and delayed puberty onset.  However, as discussed in
Questions 1.2-1.6

(See Figure 3 of the draft issue paper), new information has been
published that indicates

a more expanded understanding of how atrazine may perturb the pathway
leading to

reproductive effects.   These new data indicate that atrazine disrupts
the hypothalamic-

pituitary-adrenal (HPA) axis altering the central nervous system’s
control of the pituitary

and adrenal which, in turn, disrupts the HPG axis. Furthermore, a
hypothesis for a direct

effect of atrazine on the adrenal cortex and the gonads which may impact
steroidogenesis

directly is also supported by the available data.

Question 1.1 – With the caveat that the review of the epidemiological
literature is still on-going, please comment on the Agency’s
preliminary conclusion that new experimental data from in vitro and in
vivo laboratory animal studies do not support a change in the
conclusions from the 2003 risk assessment that atrazine is unlikely to
be a human carcinogen.

2:15 P.M. 	Charge to Panel – Question 1(continued)

Question 1.2 – Based on an evaluation of the studies examining the
mode of action of atrazine on neuroendocrine function (Section 3.2 of
the draft issue paper), the Agency has preliminarily concluded that
atrazine affects both the HPG axis and the HPA axis.  With respect to
the temporal concordance, recent studies show that atrazine induces a
rapid (within minutes) increase in ACTH and adrenal cortical hormones
(corticosterone and progesterone) in both male and female rats (Fraites
et al., 2009; Laws et al., 2009; Pruett et al., 2009), while changes in
the HPG axis, such as the suppression of the LH surge, may take up to
2-3 days (Cooper et al., 2009).  This sequence of HPA alterations
followed by HPG changes indicates that the suppression of the surge may
be, in part, mediated by activation of the HPA axis (i.e., a
corticosterone suppression of the GnRH and LH release).  In addition,
with respect to dose-response concordance, atrazine-induced increases in
ACTH, corticosterone and adrenal progesterone are seen following a
single dose of atrazine (50 mg/kg).   In contrast, the HPG is not
altered following a single dose up to 200 mg/kg. However, when treated
for multiple days, the dose necessary to alter the HPA axis is lower
than or equal to the one needed to affect the HPG axis.

Please comment on the Agency’s preliminary hypothesis for the mode of
action involving atrazine’s alteration of both the HPA and HPG axes.
Does the document adequately and clearly describe the hypothesis in the
context of a “toxicity pathway” (i.e. cellular response pathways
that, when sufficiently perturbed, are expected to result in adverse
health effects)?  Does the document clearly describe the data used to
test the proposed hypothesis? To what extent do the available data
establish key events in the proposed mode of action hypothesis?  What
are the strengths and limitations of the data available on this
hypothesis?

Please include in your comments a discussion of the Agency’s
interpretations of the data linking the initial perturbations in HPA
axis to changes in the HPG axis.

Please comment on the evidence that the initial perturbations in the HPA
axis may lead to impairment in reproductive function and/or
developmental consequences.  Which event(s) is/are viewed as critical in
leading to health consequences? Are there data on other substances that
would inform this question?

3:15 P.M. 	Break

3:30 P.M.	Charge to Panel – Question 1 (continued)

Question 1.3 – The Agency has preliminarily concluded that atrazine
directly targets cells within the HPA axis (Sections 3.2 & <IP_ADDRESS> of
the draft issue paper) and that the increased activity of the adrenal
axis does not reflect nonspecific stress.  Evidence for this conclusion
is based on the following observations.

Several studies report increased adrenocorticotropic hormone (ACTH) and
corticosterone levels immediately following a single exposure to
atrazine and its two metabolites (deisopropyl-atrazine, DIA;
deethyl-atrazine, DEA) but not diamino-s-chlorotriazine (DACT; Laws et
al., 2009; Fraites et al., 2009; Pruett et al., 2009).

A single intravenous administration of DEA in vivo (Fraites et al.,
2009) also causes an immediate increase in ACTH and adrenal hormone
release, indicating that a chlorotriazine-induced gastrointestinal
distress is not driving the hormonal response.

The adrenal corticosterone response to continued oral exposure to
atrazine did not habituate in rats (Fraites et al., 2009; Laws et al.,
2009) or mice (Pruett et al., 2009).

Although, atrazine induced a rapid increase in ACTH, prolactin secretion
was not affected in the same animals (Laws et al., 2009).  This is
unusual in that an increase in both ACTH and prolactin are typically
observed in response to a number of physiological and psychological
stressors.

Please comment on the extent to which the available evidence supports
the preliminary conclusion that atrazine and its intermediate
metabolites (DIA and DEA) induce changes in the HPA axis as a result of
a direct action on the HPA tissue and such changes are not due to a
generalized or non-specific stress response.  Are there data on other
substances that would support this conclusion?

4:15 P.M.	Charge to Panel – Question 1 (continued)

Question 1.4 – Based on a review of in vitro studies evaluating the
effects of atrazine on estrogen production, the Agency has preliminarily
concluded that atrazine does not have a direct effect on the catalytic
activity of aromatase.  However, with continued exposure (> 24 hrs)
atrazine can cause increased estrone and estradiol production in the
H295R and JEG-3 cell lines (Sanderson et al., 2000; Laville 2006; Higley
et al., 2010).   These changes in estrogen production have been
associated with increased cAMP and CYP19 mRNA (Sanderson et al., 2000,
2001) that are part of a complex mode of action through which atrazine
up-regulates the gene expression of aromatase and possibly other enzymes
within the steroidogenic pathway (Section <IP_ADDRESS> & Figure 3, Arrow 7of
the draft issue paper).  The hypothesis that atrazine alters multiple
steroids is supported by  increased testosterone concentrations in H295R
cells following exposure to atrazine (Higley et al., 2010), and in vitro
studies demonstrating that atrazine affects a number of signal
transduction pathways and/or transcription factors in a variety of cell
lines (Suzawa and Ingraham, 2008; Albanito et al., 2008).  Up-
regulation of the expression of a group of major steroidogenic genes has
been observed in JEG-3 cells (Suzawa and Ingraham, 2008).  In vivo,
there is little evidence that atrazine alters aromatase per se (Modic,
2004) and the evidence associating atrazine exposures to increases in
serum estrogens appears to be related to a general increase in gonadal
and adrenal progesterone and androstanedione (Modic 2004; Laws et al.,
2009).

Please comment on the extent that the available data do or do not
support the Agency’s

preliminary conclusion that atrazine has a general stimulatory effect on
steroidogenesis,

as opposed to a direct effect on aromatase.

5:00 P.M. 	Adjourn

DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

April 26 – 29, 2010

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2010-0125

The Hamilton Crowne Plaza Hotel

The Hamilton Ballroom

1001 14th Street, NW

Washington, DC 20005

202-682-0111

Reevaluation of the Human Health Effects of Atrazine: Review of
Experimental Animal and In Vitro Studies and Drinking Water Monitoring
Frequency

Please note that all times are approximate (see note at end of Agenda).

Wednesday, April 28,  2010

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members – Kenneth
Portier, Ph.D., FIFRA Scientific Advisory Panel Session Chair

8:45 A.M.	Charge to Panel – Question 1 (continued)

Question 1.5 – A series of studies evaluating the effect of either
peripubertal or gestational exposure of atrazine in the male rat
indicate that atrazine decreases testosterone concentrations and may
lower androgen dependent tissue weights but that it has little effect on
basal LH secretion in the male.  This response generally occurs at doses
of 50 mg/kg and above.  In contrast, atrazine in vitro has been found to
consistently increase steroid hormone production.  Thus, there is an
apparent discrepancy between the in vivo and in vitro data.  However,
our understanding of the interplay between the adrenal and the gonadal
axes may provide an explanation.   At the doses used in the in vivo
studies, atrazine induces an activation of the adrenal axis (increased
ACTH and corticosterone) and the increase in corticosterone does not
habituate (i.e., it does not lessen with repeated dosing). There are a
number of studies in the literature demonstrating that prolonged
corticosterone stimulation will impair testosterone production by a
direct action on steroidogenesis in the Leydig cells. Therefore, the in
vivo effects on testosterone synthesis are likely the result of an
adrenal hormone-mediated down regulation of HPG axis (through
corticotropin releasing hormone [CRH] modulation of GnRH pulsatility) or
directly on the testis (through a glucocorticoid receptor mediated
change in steroidogenesis).

Please comment on the degree to which the proposed mode of action
(Figure 3 of the

draft issue paper) provides a biologically plausible explanation for the
decrease in serum

and testicular testosterone identified in the in vivo studies.  Please
comment on the extent

that the available data do or do not support this hypothesis.

10:00 A.M.	Break

10:15 A.M.	Charge to Panel – Question 1(continued)

Question 1.6 - Based on a review of the neurotoxicity studies (Section
3.4 of the draft issue paper), the Agency has preliminarily concluded
that several recent studies provided further support for the concern
that dopaminergic neurotransmission may be affected by atrazine, a
concern that was raised by studies prior to 2003.  However, the Agency
has also concluded that several aspects of these studies of the
dopaminergic neuronal pathways, in particular the changes noted in
stereological evaluations and the observed changes in behavior, should
be considered as preliminary findings.  This conclusion is based on the
notable limitations identified in the data including:  (1) lack of clear
dose-response relationships, (2) lack of inclusion of suitable positive
controls to confirm the competency and reliability of the procedures
utilized in examining dopaminergic systems in the brain, (3) limited
data to corroborate stereological findings, (4) limited or no supporting
histological and behavioral assessments, and (5) no consideration of the
potential role of the HPA axis (e.g. alterations in corticosterone).
EPA has further determined that two non-dopaminergic neurotoxicity
studies--one on brain somatostatinergic systems and the other on
neurobehavior in mice -- also have significant limitations (e.g., lack
of details on source and purity of atrazine, and age and body weights of
the mice; poor quality of amino cupric silver staining photomicrographs;
limited presentation of reverse-transcriptase polymerase chain results;
lack of data to corroborate conclusion of neuronal degeneration;
reference citations did not support statements made in the text; no
explanation of biological plausibility of alterations in
somatostatinergic receptor subtypes; inappropriate statistical
evaluation of data (litter vs. pup); discrepancies in number of pups
examined for behavioral endpoints, and lack of objective and validated
behavioral tests).  Please comment on these preliminary conclusions
regarding the neurotoxicity findings.

The Agency has preliminarily concluded that the available studies
indicate that the

neurotoxicity endpoints examined are not more sensitive than those
evaluated for

neuroendocrine function following atrazine exposure (e.g., attenuation
of LH surge and

estrous cycle disruptions in female Sprague-Dawley rats which form the
basis for the

current chronic RfD).  In addition, the Agency has concluded that there
is no association

 between atrazine exposure and development of Parkinson’s Disease on
the basis of non-

specificity of effects on brain dopaminergic systems, lack of
histological and behavioral

features characteristic of Parkinson’s Disease, and results of
epidemiological studies.

Please comment on this preliminary conclusion.

11:00 A.M.	Charge to Panel – Question 1(continued)

Question 1.7 – Based on a review of two studies of the potential
effects of atrazine on the prostate (Section <IP_ADDRESS> of the draft issue
paper), the Agency has concluded that the results of the Rayner et al.
(2007) study of pregnant rats treated during gestation support previous
observations (Stoker et al., 1999) that atrazine treatment to the rat
dam either perinatally or early postnatally can increase prostate
weights (due to an increase in inflammatory infiltrate) in the male
offspring.  This effect on the offspring was shown to be due to a
suppression of prolactin in the atrazine-exposed dams during lactation,
and is consistent with the mode of action of atrazine on neuroendocrine
function.   The Agency also preliminarily concluded that further
research is needed to provide more convincing evidence that
atrazine-mediated suppression of prostate cancer in the probasin/SV40T
antigen transgenic rat (androgen-dependent prostate cancer rodent model)
 may possibly be due to caloric restriction rather than
endocrine-related as postulated by Kandori et al. (2005).  Please
comment on these preliminary conclusions regarding the recent prostate
findings.

Please comment on the extent to which the available data support the
proposed mode of

action for prostatitis and the appropriateness of the rodent model in
the context of human

health.

12:00 noon	Lunch

1:15 P.M.	Charge to Panel – Question 1 (continued)

Question 1.8 – Based on data obtained in studies to assess the effects
of atrazine on the immune system following developmental and adult
exposure, as well as in vitro mechanistic studies, EPA concluded that
atrazine has the potential to affect the immune system (Section 3.5 of
the draft issue paper).  However, the Agency has also concluded that
underlying mechanisms of atrazine-mediated immunotoxicity and its
relevance to potential adverse health effects in humans are still not
thoroughly understood.  It is well established that products of the
endocrine system modulate immune function.  However, adult rodent
studies have not determined whether immune system effects are caused by
direct effects of atrazine and/or its metabolites or whether they are
the result of modulated endocrine hormone production, which in turn
affects immune cells.  Two published studies indicate that exposure to
atrazine during immune system development may result in altered immune
function in offspring, although no conclusions were drawn on the
potential adversity of the effects, because immunosuppression was
observed in one study and immunoenhancement was observed in the other.
Please comment on potential explanations for the disparate findings
reported by Rooney et al. and Rowe et al.  Many immunotoxicologists
consider immunomodulation, i.e., suppression or enhancement of immune
function, as a potentially adverse alteration of homeostasis, because
both have been associated with disease states.   Thus, while the results
Rooney et al. and Rowe et al. may appear to be contradictory, together
the data indicate unintended immunomodulation at approximately the same
dose in two species.  Please comment on characterizing the effects of
gestational atrazine exposure as immunomodulation, when describing the
immunotoxicological outcome of developmental immunotoxicity studies.

Appendix B of the draft issue paper describes experiments conducted by
EPA scientists on the potential developmental immunotoxicity of
atrazine.  The results of the experiments provide conflicting results.
Additional studies did not provide a suitable explanation of the
differences.  The Agency believes both sets of data are of high quality.
 However, in the context of hazard assessment, such differences are
difficult to interpret.  Please comment on the information contained in
Appendix B and provide suggestions for interpreting such data as part of
the atrazine re-evaluation.

The available data do not indicate that atrazine-induced immunotoxicity
is a more

sensitive endpoint than the atrazine-induced effects on neuroendocrine
function, (e.g.,

attenuation of LH surge and estrous cycle disruptions which form the
basis for the current

 chronic RfD) in female Sprague-Dawley rats.  Please comment on the
degree to which

 these preliminary conclusions are supported by the available data.

2:00 P.M.	Charge to Panel – Question 1(continued)

Question 1.9 – After the April 2010 SAP, the Agency will evaluate the
weight of evidence (WOE) for atrazine by integrating the experimental
toxicology data with the epidemiological studies.  As part of this work,
the Agency will consider the available data on hormonal changes and
functional outcomes that may be used as endpoints for deriving PoDs
across different durations of exposure and for different populations
(including potentially sensitive ones).  Important studies evaluating
the dose-response relationships for hormones involved in the HPA axis
are still on-going.  These studies are expected to provide high quality
data that can be used to characterize the entire dose response curve.
With the caveat that these data are not available now, given the current
understanding of atrazine’s mode of action, please comment on what
would be appropriate endpoints to consider for use in deriving points of
departure in a possible future risk assessment.

Given that the duration of the toxicological concern is a key factor in
evaluating the frequency of drinking water monitoring, please include in
your response a consideration of the magnitude and duration of changes
in key events in the toxicity pathway that are sufficient perturb normal
function and comprise human health.   In defining the exposure window of
interest, please comment on the toxicokinetic/dynamic considerations
with respect to atrazine's effects on the HPA/HPG axis.

3:00 P.M. 	Break

3:15 P.M.	Charge to Panel – Question 2

Approaches to Evaluating Water Sampling Strategies & Frequency of
Monitoring

In conjunction with the toxicological review presented in the issue
paper, the Agency has also discussed methods for re-evaluating the
sampling frequency that is necessary for determining, with confidence,
concentrations of the pesticide in water that sources drinking water.
These have included different methods for estimating pesticide
concentrations between known sampling events and examining the
performance of different sampling strategies for averaging periods of
different durations.  The Agency seeks feedback from the Panel with
regard to how the uncertainty and variability in both the monitoring
data and in the toxicity data (i.e., point of departure) can be
integrated to characterize and to interpret the potential significance
of atrazine concentrations in drinking water.

Question 2.1 – Given the nature of the temporal patterns of pesticide
occurrence in surface waters described in Section 5.2, including serial
correlations from day to day, periodicity in elevated concentrations
within seasons and from year to year, below quantitation data, and
uncertainty in the shape of the pesticide distributions in surface
waters--what statistical approaches should the Agency consider in
determining confidence bounds on exposure estimates from monitoring
data? Please comment on how the approach may vary depending on the
duration of concern.

4:00 P.M. 	Charge to Panel – Question 2 (continued)

Question 2.2 – The first two simulation methods presented in Section
5.5 are applicable to the specific data sets they describe, although
some generalities regarding shape patterns appear to exist.  Given this
information, please comment on the strengths and weaknesses of the
approaches and on the practical merits of pursuing them or some other
numerical approach with a larger set of higher concentration systems.
Please comment on how the methods for determining confidence bounds
might apply given these considerations.

5:00 P.M.	Adjourn

DRAFT AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

April 26 – 29, 2010

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone:<PHONE_NUMBER>

Docket Number: EPA-HQ-OPP-2010-0125

The Hamilton Crowne Plaza Hotel

The Hamilton Ballroom

1001 14th Street, NW

Washington, DC 20005

202-682-0111

Reevaluation of the Human Health Effects of Atrazine: Review of
Experimental Animal and In Vitro Studies and Drinking Water Monitoring
Frequency

Please note that all times are approximate (see note at end of Agenda).

Thursday, April 29,  2010

8:30 A.M.	Opening of Meeting and Administrative Procedures – Joseph
Bailey, Designated Federal Official, Office of Science Coordination and
Policy, EPA

8:35 A.M. 	Introduction and Identification of Panel Members – Kenneth
Portier, Ph.D., FIFRA Scientific Advisory Panel Session Chair

8:45 A.M.	Charge to Panel – Question 2 (continued)

Question 2.3 – As described in Section 5.4.2, the Agency is
considering the use of a confidence interval or prediction interval
approach to characterize the uncertainty of exposure estimates derived
from monitoring data of varying sampling frequencies.  Please comment on
the strengths and weaknesses of either placing confidence bounds on the
rolling average estimates and comparing the upper limit from monitoring
against the level of concern (LOC) or, conversely, placing confidence
bounds on the LOC.

9:45 A.M.	Charge to Panel – Question 2 (continued)

Question 2.4 – Please comment on the relative merits of the various
modeling approaches the Agency described in Section 5.4.1 and 5.6 for
interpolating pesticide concentrations between sampling points and, in
particular, on the strengths and weaknesses of these methods as the
frequency of samples decreases. Considering the health endpoint(s) being
considered for atrazine, particularly data for the HPA axis, and the
exposure time frame needed to induce the health effect(s) which is
shorter than that used in the 2003 risk assessment, please comment on
the advantages and disadvantages of each model for evaluating the likely
occurrence and exposure via drinking water of short, moderate, and long
duration concentrations.  Please comment on the Agency’s proposed
approach for evaluating these methods, as described in Section 5.7.1.
To what extent should the Agency consider other factors, such as the
shape of the chemograph (Section 5.5.3), weather patterns, stream flow,
and/or pesticide use patterns in evaluating the modeling approaches?

10:30 A.M.	Break

10: 45 A.M.	Charge to Panel – Discussion continued as needed

12:00 noon	Lunch

1:15 P.M.	Charge to Panel – Discussion continued as needed

3:00 P.M. 	Break

3:15 P.M.	Charge to Panel – Discussion continued as needed

5:00 P.M.	Adjourn

Please be advised that agenda times are approximate; when the discussion
for one topic is completed, discussions for the next topic will begin.
For further information, please contact the Designated Federal Official
for this meeting, Joseph Bailey, via telephone:<PHONE_NUMBER>; fax:
(202) 564-8382; or email<EMAIL_ADDRESS>
 PAGE

 PAGE   3


[Federal Register Volume 78, Number 77 (Monday, April 22, 2013)]
[Proposed Rules]
[Pages 23688-23690]
[FR Doc No: 2013-09415]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0349; Directorate Identifier 2012-SW-058-AD]
RIN 2120-AA64

Airworthiness Directives; Bell Helicopter Textron Canada Inc.
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Bell Helicopter Textron Canada Inc. (BHT) Model 206A, 206B, and
206L helicopters. This proposed AD would require replacing certain
part-numbered engine auto-relight kit control boxes. This proposed AD
is prompted by a design review that revealed the control box chipset
did not meet the required temperature range requirements, which could
cause the control box to malfunction, disabling the engine auto-relight
system. This condition could result in increased pilot workload during
a power loss emergency and subsequent loss of control of the aircraft.

DATES: We must receive comments on this proposed AD by June 21, 2013.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the

Docket Operations Office between 9 a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD docket contains this proposed
AD, the economic evaluation, any comments received, and other
information. The street address for the Docket Operations Office
(telephone<PHONE_NUMBER>) is in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.
    For service information identified in this proposed AD, contact
Bell Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir,
Mirabel, Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax
(450) 433-0272; or at http://www.bellcustomer.com/files/. You may
review the referenced service information at the FAA, Office of the
Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort
Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Rao Edupuganti, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    Transport Canada (TC), which is the aviation authority for Canada,
has issued TC AD No. CF-2012-19, dated June 12, 2012 (CF-2012-19), to
correct an unsafe condition for certain serial numbered BHT Model 206A,
206B, and 206L helicopters with an engine auto-relight kit control box
assembly (control box assembly) part number 206-375-017-101 or 206-375-
017-103 installed. TC advises that these control box assemblies have a
manufacturing defect which could disable the auto-relight system in the
event of an engine flameout, subsequently requiring the pilot to re-
start the engine manually. This condition could result in increased
pilot workload during a power loss emergency in-flight and subsequent
loss of control of the helicopter. CF-2012-19 specifies replacing the
affected control boxes within 4 months to correct the unsafe condition.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
our bilateral agreement with Canada, TC, its technical representative,
has notified us of the unsafe condition described in its AD. We are
proposing this AD because we evaluated all known relevant information
and determined that an unsafe condition is likely to exist or develop
on other products of the same type design.

Related Service Information

    BHT has issued Alert Service Bulletin (ASB) No. 206-11-127 for
Model 206A and 206B helicopters and ASB No. 206L-11-167 for Model 206L
helicopters, both dated May 2, 2011. Both ASBs specify replacing the
affected control box assembly with an upgraded control box assembly.

Proposed AD Requirements

    This proposed AD would require replacing the control box assembly
within 4 months.

Costs of Compliance

    We estimate that this proposed AD would affect 1,357 helicopters of
U.S. Registry. We estimate that operators may incur the following costs
in order to comply with this AD. If installed, replacing the control
box assembly would require about 2 work-hours at an average labor rate
of $85 per hour and required parts would cost about $18,974, for a cost
per helicopter of $19,144.
    According to BHT's service information, some of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. We do not control warranty coverage by
BHT. Accordingly, we have included all costs in our cost estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect 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.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

Bell Helicopter Textron Canada Inc (BHT): Docket No. FAA-2013-0349;
Directorate Identifier 2012-SW-058-AD.

(a) Applicability

    This AD applies to the following helicopters, certificated in
any category:
    (1) BHT Model 206A and 206B helicopters, all serial numbers (S/
N) except S/Ns 1, 2, and 3, with an engine auto-relight kit control
box assembly (control box assembly) part number (P/N) 206-375-017-
101 installed; and
    (2) BHT Model 206L helicopters, S/N 45001 through 45153 and
46601 through 46617, with a control box assembly P/N 206-375-017-103
installed.

(b) Unsafe Condition

    This AD defines the unsafe condition as an inoperative control
box assembly. This condition could result in a disabled auto-relight
system, failure of the engine to relight after a flame-out,
increased pilot workload during a power loss emergency, and
subsequent loss of control of the helicopter.

(c) Reserved

(d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    Within 4 months, replace the control box assembly:
    (1) For Model 206A and 206B helicopters, replace control box
assembly P/N 206-375-017-101 with a control box assembly P/N 206-
375-017-105.
    (2) For Model 206L helicopters, replace control box assembly P/N
206-375-017-103 with a control box assembly P/N 206-375-017-107.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, FAA, may approve AMOCs
for this AD. Send your proposal to: Rao Edupuganti, Aviation Safety
Engineer, Regulations and Policy Group, Rotorcraft Directorate, FAA,
2601 Meacham Blvd., Fort Worth, Texas 76137; telephone (817) 222-
5110; email<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) BHT Alert Service Bulletin (ASB) No. 206-11-127 for Model
206A and 206B helicopters and ASB No. 206L-11-167 for Model 206L
helicopters, both dated May 2, 2011, which are not incorporated by
reference, contain additional information about the subject of this
AD. For service information identified in this AD, contact Bell
Helicopter Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J1R4; telephone<PHONE_NUMBER> or<PHONE_NUMBER>; fax (450)
433-0272; or at http://www.bellcustomer.com/files/. You may review a
copy of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth,
Texas 76137.
    (2) The subject of this AD is addressed in Transport Canada AD
CF-2012-19, dated June 12, 2012.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 7410: Ignition
Power Supply.

    Issued in Fort Worth, Texas, on April 11, 2013.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2013-09415 Filed 4-19-13; 8:45 am]
BILLING CODE 4910-13-P