[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Proposed Rules]
[Pages 16620-16622]
[FR Doc No: 2013-06118]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0072; Directorate Identifier 2013-NE-04-AD]
RIN 2120-AA64

Airworthiness Directives; Pratt & Whitney Division Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Pratt & Whitney Division (PW) turbofan engine models PW4074, PW4074D,
PW4077, PW4077D, PW4084D, PW4090, and PW4090-3 with a certain 2nd-stage
high-pressure turbine (HPT) air seal part number (P/N) installed. This
proposed AD was prompted by discovery of cracks in the 2nd-stage HPT
air seals. This proposed AD would require, for those air seals that
meet certain cycles since new (CSN) criteria, inspection and removal
from service of HPT air seals that fail inspection. We are proposing
this AD to prevent failure of the 2nd-stage HPT air seal, which could
lead to an uncontained engine failure and damage to the airplane.

DATES: We must receive comments on this proposed AD by May 17, 2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this AD, contact Pratt &
Whitney, 400 Main St., East Hartford, CT 06108; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>. You may view this service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Ian Dargin, Aerospace Engineer, Engine
& Propeller Directorate, FAA, 12 New England Executive Park,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2013-0072;
Directorate Identifier 2013-NE-04-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We propose to adopt a new AD for all PW turbofan engine models
PW4074, PW4074D, PW4077, PW4077D, PW4084D, PW4090, and PW4090-3 with
2nd-stage HPT air seal, P/N 54L041, installed. This proposed AD was
prompted by cracks in 2nd-stage HPT air seals discovered during
fluorescent-penetrant inspection (FPI). This proposed AD would require,
for HPT air seals that meet certain CSN criteria, either on-wing eddy
current inspection (ECI) or in-shop FPI, and removal from service of
any HPT air seal that fails inspection. We are proposing this AD to
prevent failure of the 2nd-stage HPT air seal. This condition, if not
corrected, could lead to an uncontained engine failure, and damage to
the airplane.

Relevant Service Information

    We reviewed PW Alert Service Bulletin (ASB) PW4G-112-A72-330,
Revision 1, dated February 26, 2013. The ASB describes procedures for
inspecting the integrity of 2nd-stage HPT air seals and criteria for
their removal from service and replacement.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in the service information described previously.

Interim Action

    We consider this proposed AD interim action. PW has not determined
the root cause of the cracks discovered in 2nd-stage HPT air seals.

Costs of Compliance

    We estimate that this AD will affect 83 engines installed on
airplanes of U.S. registry. We also estimate that it would take about 5
hours to perform the inspection required by this proposed AD. The costs
of an ECI and an FPI are assumed to be equal. The average labor rate is
$85 per hour. Based on these figures, we estimate the total cost of the
AD to U.S. operators will be $35,275.

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 above, 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.

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):

Pratt & Whitney Division: Docket No. FAA-2013-0072; Directorate
Identifier 2013-NE-04-AD.

(a) Comments Due Date

    We must receive comments by May 17, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Pratt & Whitney Division (PW) turbofan
engine models PW4074, PW4074D, PW4077, PW4077D, PW4084D, PW4090, and
PW4090-3 with 2nd-stage high-pressure turbine (HPT) air seal, part
number 54L041, installed.

(d) Unsafe Condition

    This AD was prompted by discovery of cracks in the 2nd-stage HPT
air seals. We are issuing this AD to prevent failure of the 2nd-
stage HPT air seal, which could lead to uncontained engine failure
and damage to the airplane.

(e) Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) For 2nd-stage HPT air seals that have 1,200 or fewer cycles
since new (CSN) on the effective date of this AD, perform an on-wing
eddy current inspection (ECI) or in-shop fluorescent-penetrant
inspection (FPI) for cracks within 2,200 CSN.
    (2) For 2nd-stage HPT air seals that have more than 1,200 CSN on
the effective date of this AD, perform an on-wing ECI or in-shop FPI
for cracks within 1,000 cycles after the effective date of this AD.
    (3) Thereafter, reinspect with either an on-wing ECI or in-shop
FPI every 1,200 cycles since last inspection.
    (4) If you find a crack, remove the air seal from service before
further flight.
    (5) Use paragraph 7 of the Accomplishment Instructions of PW
Alert Service Bulletin (ASB) PW4G-112-A72-330, Revision 1, dated
February 26, 2013, to do the on-wing ECI, except the reporting
requirement of that step.

(f) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(g) Related Information

    (1) For more information about this AD, contact Ian Dargin,
Aerospace Engineer, Engine & Propeller Directorate, FAA, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) Refer to PW ASB PW4G-112-A72-330, Revision 1, dated February
26, 2013, for related information.
    (3) For service information identified in this AD, contact Pratt
& Whitney, 400 Main St., East Hartford, CT 06108; phone: 860-565-
8770; fax:<PHONE_NUMBER>. You may view this service information at
the FAA, Engine & Propeller Directorate, 12 New England Executive
Park, Burlington, MA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on March 4, 2013.
Colleen M. D'Alessandro,
Assistant Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2013-06118 Filed 3-15-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 152 (Monday, August 8, 2016)]
[Rules and Regulations]
[Pages 52348-52352]
[FR Doc No: 2016-18666]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0561; FRL-9949-19]

Flonicamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of
flonicamid in or on hops, tree nuts (crop group 14-12 except
pistachio), and pistachio. ISK Biosciences Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective August 8, 2016. Objections and
requests for hearings must be received on or before October 7, 2016,
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-2015-0561, 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), West William Jefferson Clinton 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan T. Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main 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-2015-0561 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 October 7, 2016. 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-2015-0561, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.

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

II. Summary of Petitioned-For Tolerance

    In the Federal Register of October 21, 2015 (80 FR 63731) (FRL-
9935-29), 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
5F8369) by ISK Biosciences Corporation, 7470 Auburn Road, Suite A,
Concord, Ohio 44077. The petition requested that 40 CFR 180.613 be
amended by establishing tolerances for residues of the insecticide
flonicamid, [(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide)
or (N-cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on
hops at 20 parts per million (ppm), tree nuts (crop group 14-12) except
pistachio at 0.15 parts per million (ppm), pistachio at 0.60 parts per
million (ppm). That document referenced a summary of the petition
prepared by ISK Bioscience Corporation, the registrant, which is
available in the docket, http://www.regulations.gov. There were no
comments received in response to the notice of filing.

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 flonicamid including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with flonicamid 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. Specific information on the studies received and the nature
of the adverse effects caused by flonicamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule
published in the Federal Register of November 14, 2012 (77 FR 67771)
(FRL-9368-7).

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for flonicamid used for
human risk assessment is discussed in Unit III.B of the final rule
published in the Federal Register of November 14, 2012.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to flonicamid, EPA considered exposure under the petitioned-
for tolerances as well as all existing flonicamid tolerances in 40 CFR
180.613. EPA assessed dietary exposures from flonicamid in food as
follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure. No such effects were
identified in the toxicological studies for flonicamid; therefore, a
quantitative

acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA's National
Health and Nutrition Examination Survey, What We Eat in America,
(NHANES/WWEIA). As to residue levels in food, the chronic dietary
exposure assessment was a conservative assessment conducted using
tolerance-level residues, conservative ground water/drinking water
estimates, and 100 percent crop treated (PCT).
    iii. Cancer. Based on the data referenced in Unit III.A., EPA has
concluded that flonicamid does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for flonicamid. Tolerance level residues and/or 100 PCT were assumed
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening
level water exposure models in the dietary exposure analysis and risk
assessment for flonicamid in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of flonicamid. 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.
    The drinking water assessment was conducted using both a parent
only exposure, and a total toxic residue approach, which considers the
parent compound and its major degradates of concern. Total toxic
residues include 4-trifluoromethylnicotinic acid (TFNA), 4-
trifluoromethylnictinamide (TFNA-AM), 6-hydro-4-
trifluoromethylnicotinic acid (TFNA-OH), N-(4-
trifluoromethylnicotinoyl)glycine (TFNG), and N-(4-
trifluoromethylnicotinoyl)glycinamide (TFNG-AM).
    Based on the Pesticide Root Zone Model Ground Water (PRZM GW), the
estimated drinking water concentrations (EDWCs) of flonicamid for
chronic exposures for non-cancer assessments are estimated to be 0.94
parts per billion (ppb) for surface water and 9.92 ppb for ground
water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 9.92 ppb was used to
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Flonicamid is not
registered for any specific use patterns that would result in
residential exposure.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.'' EPA has not found
flonicamid to share a common mechanism of toxicity with any other
substances, and flonicamid does not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has assumed that flonicamid does not
have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a
common mechanism of toxicity and to evaluate the cumulative effects of
such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal
toxicity database for flonicamid includes prenatal developmental
toxicity studies in rats and rabbits and a multi-generation
reproduction toxicity study in rats. There is no evidence of increased
susceptibility (qualitative or quantitative) in rats or rabbits exposed
to flonicamid in utero in the prenatal developmental studies or in
young rats in the multi-generation reproduction study. No developmental
effects were seen in rabbits. In the multi-generation reproduction
study, developmental delays in the offspring (decreased body weights,
delayed sexual maturation) were seen only in the presence of parental
toxicity (kidney and blood effects). Also, there are clear NOAELs and
LOAELs for all effects. The degree of concern for prenatal and/or
postnatal susceptibility is, therefore, low due to the lack of evidence
of qualitative and quantitative susceptibility.
    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, except as noted below. That decision is
based on the following findings:
    i. The toxicity database for flonicamid is nearly complete. The
database is missing a subchronic inhalation study. A subchronic
inhalation study is required because the use of an oral POD results in
MOEs which do not meet the target MOE for a waiver (MOE=1,000). The
Agency notified the registrant of the Data Call-In (DCI) for the 28-day
inhalation study on January 5, 2016 and is awaiting submission of the
study. In the absence of a subchronic inhalation study, EPA has
retained a 10X FQPA SF to assess risks for inhalation exposure
scenarios. However, residential inhalation exposures are not expected.
    ii. The available data base for flonicamid includes acute and
subchronic neurotoxicity studies. As discussed in Unit III.A., EPA has
concluded that the clinical signs observed in those studies were not
the result of a neurotoxic mechanism and therefore a developmental
neurotoxicity study is not required.
    iii. There is no evidence that flonicamid 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 chronic dietary food exposure assessment was based on
100 PCT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to flonicamid in drinking water. These assessments
will not underestimate the exposure and risks posed by flonicamid.

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. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
flonicamid is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
flonicamid from food and water will utilize 30% of the cPAD for
children 1-2 years old, the population group receiving the greatest
exposure. There are no residential uses for flonicamid. Based on the
explanation in Unit III.C.3., regarding residential use patterns,
chronic residential exposure to residues of flonicamid is not expected.
    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). A short-term
adverse effect was identified; however, flonicamid is not registered
for any use patterns that would result in short-term residential
exposure. Short-term risk is assessed based on short-term residential
exposure plus chronic dietary exposure. Because there is no short-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess short-term risk), no further
assessment of short-term risk is necessary, and EPA relies on the
chronic dietary risk assessment for evaluating short-term risk for
flonicamid.
    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). An intermediate-term adverse effect was identified; however,
flonicamid is not registered for any use patterns that would result in
intermediate-term residential exposure. Intermediate-term risk is
assessed based on intermediate-term residential exposure plus chronic
dietary exposure. Because there is no intermediate-term residential
exposure and chronic dietary exposure has already been assessed under
the appropriately protective cPAD (which is at least as protective as
the POD used to assess intermediate-term risk), no further assessment
of intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating intermediate-term risk for
flonicamid.
    5. Aggregate cancer risk for U.S. population. Based on the
information referenced in Unit III.A., EPA has concluded that the cPAD
is protective of possible cancer effects from flonicamid, and as
evidenced in Unit III.E.2, aggregate exposure to flonicamid is below
the cPAD.
    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 flonicamid residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (FMC Method No. P-3561M, a liquid
chromatography with tandem mass spectrometry (LC/MS/MS) method) is
available to enforce the tolerance expression for flonicamid and its
metabolites in or on plant commodities.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not proposed an MRL for flonicamid in or on
pistachio. The Codex has established an MRL for flonicamid in or on
hops at 20.0 ppm. These MRLs are the same as the tolerances established
for flonicamid in the United States. The Codex has also established
MRLs for flonicamid in or on almond and pecan at 0.01 ppm. These MRLs
are different than the tolerances established for flonicamid in the
United States. The U.S. cannot harmonize the Nut, tree, group 14-12,
except pistachio tolerance with the Codex MRLs on pecan and almond
because residue field trial data show residues well above 0.01 ppm.

C. Revisions to Petitioned-For Tolerances

    The Agency is removing certain commodities from the table at Sec.
180.613 (a) to eliminate redundancies upon the establishment of new
crop group tolerances that were not identified in the petition:
Cucumber at 1.5 ppm and okra at 0.40 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of flonicamid,
[(N-(cyanomethyl)-4-trifluoromethyl)-3-pyridinecarboxamide) or (N-
cyanomethyl-4-trifluoromethylnicotinamide (IUPAC))], in or on hops at
20.0 ppm, tree nuts (crop group 14-12) except pistachio at 0.15 ppm,
and pistachio at 0.60 ppm.
    Also, as a housekeeping measure, the Agency is removing three
individual tolerances that are subsumed within other crop group
tolerances contained in Sec.  180.613: Cucumber at 1.5 ppm is
superseded by inclusion in the established vegetable, cucurbit, group 9
tolerance at 1.5 ppm; and okra at 0.40 ppm is superseded by inclusion
in the established vegetable, fruiting, group 8-10 tolerance at 0.40
ppm.

VI. Statutory and Executive Order Reviews

    This action 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 action has been
exempted from review under

Executive Order 12866, this action 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 action 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 action 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 action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(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 (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: July 26, 2016.
Daniel J. Rosenblatt,
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.  180.613, amend the table in paragraph (a)(1) as follows:
0
a. Remove the commodities ``Cucumber'' and ``Okra''.
0
b. Revise the commodities ``Hop, dried cones'' and ``Nut, Tree, group
14-12''.
0
c. Add alphabetically the commodity ``Pistachio''.
    The revisions and addition read as follows:

Sec.  180.613  Flonicamid; tolerances for residues.

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

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

                                * * * * *
Hop, dried cones........................................            20.0
Nut, Tree, group 14-12 except pistachio.................            0.15

                                * * * * *
Pistachio...............................................            0.60

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

* * * * *
[FR Doc. 2016-18666 Filed 8-5-16; 8:45 am]
 BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's (FDA) Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed Reg 23, 142 and Federal Register No 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science-based and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on the proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 81, Number 223 (Friday, November 18, 2016)]
[Notices]
[Page 81858]
[FR Doc No: 2016-27796]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Ninety Seventh Plenary for RTCA SC-159 Navigation Equipment Using
the Global Positioning System

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Ninety Seventh Plenary for RTCA SC-159 Navigation Equipment
Using the Global Positioning System.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of Ninety Seventh Plenary for RTCA SC-159 Navigation Equipment
Using the Global Positioning System.

DATES: The meeting will be held December 13, 2016 10:30 a.m.-12:00 p.m.

ADDRESSES: The meeting will be held at: RTCA Headquarters, 1150 18th
Street NW., Suite 910, Washington, DC 20036.

FOR FURTHER INFORMATION CONTACT: Rebecca Morrison at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or The RTCA Secretariat, 1150 18th Street NW., Suite
910, Washington, DC, 20036, or by telephone at<PHONE_NUMBER>, fax at
(202) 833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a) (2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the Ninety Seventh RTCA SC-159 Navigation
Equipment Using the Global Positioning System. The agenda will include
the following:

Tuesday, December 13, 2016, 10:30 a.m.-12:00 p.m.
1. Introductory Remarks: DFO, RTCA and Chairman
2. Presentation by WG-6 of comments on the Ligado Proposal dated August
30, 2016 with discussion for review and approval by SC-159
3. Other Business
4. Adjourn

    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on November 15, 2016.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17,
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2016-27796 Filed 11-17-16; 8:45 am]
 BILLING CODE 4910-13-P


	ENVIRONMENTAL PROTECTION AGENCY

	40 CFR Part 52

[EPA-R03-OAR-2007-1139; FRL-        ]

Approval and Promulgation of Air Quality Implementation Plans; Virginia;
Control of Volatile Organic Compound (VOCs) Emissions from the Kraft
Foods Global, Inc.— Richmond Bakery located in Henrico County,
Virginia

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Proposed rule.

SUMMARY:  EPA is proposing to approve a State Implementation Plan (SIP)
revision submitted by the Commonwealth of Virginia on October 29, 2007.
This revision pertains to a federally enforceable state operating permit
containing terms and conditions for the control of emissions of volatile
organic compounds (VOCs) from the Kraft Foods Global, Inc.—Richmond
Bakery located in Henrico County, Virginia.  The submittal is for the
purpose of meeting the requirements for reasonably available control
technology (RACT) in order to implement the maintenance plan for the
Richmond 8-hour ozone maintenance area.  EPA is proposing to approve the
revision to the Virginia SIP in accordance with the requirements of the
Clean Air Act (CAA).

DATES: Written comments must be received on or before [insert date 30
days from date of publication].

ADDRESSES:  Submit your comments, identified by Docket ID Number
EPA-R03-OAR-2007-1139, by one of the following methods:

   HYPERLINK "http://www.regulations.gov"  www.regulations.gov .  Follow
the on-line instructions for submitting comments.

     B.    E-mail:    HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

     C.    Mail:  EPA-R03-OAR-2007-1139, Cristina Fernandez, Chief, Air
Quality Planning Branch, Mailcode 3AP21, U.S. Environmental Protection
Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103.

     D.   Hand Delivery:  At the previously-listed EPA Region III
address.  Such deliveries are only accepted during the Docket(s normal
hours of operation, and special arrangements should be made for
deliveries of boxed information.

Instructions:  Direct your comments to Docket ID No.
EPA-R03-OAR-2007-1139.  EPA's policy is that all comments received will
be included in the public docket without change, and may be made
available online at www.regulations.gov, including any personal
information provided, unless the comment includes information claimed to
be Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through www.regulations.gov or
e-mail.  The www.regulations.gov website is an (anonymous access(
system, which means EPA will not know your identity or contact
information unless you provide it in the body of your comment.  If you
send an e-mail comment directly to EPA without going through
www.regulations.gov, your e-mail address will be automatically captured
and included as part of the comment that is placed in the public docket
and made available on the Internet.  If you submit an electronic
comment, EPA recommends that you include your name and other contact
information in the body of your comment and with any disk or CD-ROM you
submit.  If EPA cannot read your comment due to technical difficulties
and cannot contact you for clarification, EPA may not be able to
consider your comment.  Electronic files should avoid the use of special
characters, any form of encryption, and be free of any defects or
viruses.

Docket:  All documents in the electronic docket are listed in the
www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute.  Certain other material, such
as copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form.  Publicly available docket
materials are available either electronically in www.regulations.gov or
in hard copy during normal business hours at the Air Protection
Division, U.S. Environmental Protection Agency, Region III, 1650 Arch
Street, Philadelphia, Pennsylvania 19103. Copies of the State submittal
are available at the Virginia Department of Environmental Quality, 629
East Main Street, Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT:  Irene Shandruk,<PHONE_NUMBER>, or by
e-mail at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>.

SUPPLEMENTARY INFORMATION:  On October 29, 2007, the Commonwealth of
Virginia submitted a revision to its State Implementation Plan (SIP) for
the control of emissions of VOCs from the Kraft Foods Global, Inc. –
Richmond Bakery located in Henrico County, Virginia.  The submittal is
for the purpose of meeting the requirements for Reasonably Available
Control Technology (RACT) in order to implement the maintenance plan for
the Richmond 8-hour ozone maintenance area.

I.    Background

RACT is the lowest emission limit that a particular source is capable of
meeting by the application of control technology that is reasonably
available with the consideration of technological and economic
feasibility.  When the Richmond area was originally designated as an
ozone nonattainment area under the 1-hour standard, it was classified as
moderate and thereby had to meet the non-CTG RACT requirements of
section 182 of the CAA.  As part of the 1-hour ozone attainment plan,
one of the sources located in the area identified as being subject to
non-CTG RACT was Nabisco Brands (now Kraft Foods).  Cookies, crackers,
and pretzels are produced at this plant.  The sources of VOC emissions
at this plant are proof-room, ovens for baking the dough, and oil
treatment facilities.

The Kraft Foods Global, Inc. in Henrico County, Virginia underwent RACT
analysis, and a federally-enforceable state operating permit was issued
to the facility, which became effective on April 24, 1991.  The permit
was then submitted to EPA as a SIP revision, and approved into the
Commonwealth’s SIP on March 6, 1992 (57 FR 8080).

On September 22, 2004, under the new 8-hour ozone standard, the Richmond
area was classified as a marginal nonattainment area.  On September 20,
2006, the Virginia Department of Environmental Quality (VADEQ) formally
submitted a request to redesignate the Richmond area from nonattainment
to attainment for the 8-hour ozone NAAQS.  On September 25, 2006, the
VADEQ submitted a maintenance plan for the Richmond area as a SIP
revision to ensure continued attainment.  The redesignation request and
maintenance plan were approved on June 1, 2007 (72 FR 30485).  Section
107(d)(3)(E) of the CAA stipulates that for an area to be redesignated,
EPA must approve a maintenance plan that meets the requirements of
section 175A.  All applicable nonattainment area requirements remain in
place.  The plan includes a demonstration that emissions will remain
within the 2005 levels for a 10-year period by keeping in place key
elements of the current federal and state regulatory programs, including
case-by-case RACT requirements for the area.  Because the Richmond area
in which this facility is located has continuously been classified as
either a nonattainment or a maintenance area, the RACT requirements
remain in effect.

II.   Summary of SIP Revision

In 2006, Kraft made modifications to its process that necessitated the
following revisions to its RACT permit:  (1) Kraft will demonstrate
compliance with RACT for oven #1 by testing the catalyst annually to
demonstrate that it is functioning properly; and (2) Compliance with the
exhaust gas flow through the catalytic oxidizer will be achieved by
installing and operating the fan model with a rated capacity no less
than 3,500 scfm.

III. General Information Pertaining to SIP Submittals from the
Commonwealth of Virginia

In 1995, Virginia adopted legislation that provides, subject to certain
conditions, for an environmental assessment (audit) (privilege” for
voluntary compliance evaluations performed by a regulated entity.  The
legislation further addresses the relative burden of proof for parties
either asserting the privilege or seeking disclosure of documents for
which the privilege is claimed.  Virginia's legislation also provides,
subject to certain conditions, for a penalty waiver for violations of
environmental laws when a regulated entity discovers such violations
pursuant to a voluntary compliance evaluation and voluntarily discloses
such violations to the Commonwealth and takes prompt and appropriate
measures to remedy the violations.  Virginia's Voluntary Environmental
Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege
that protects from disclosure documents and information about the
content of those documents that are the product of a voluntary
environmental assessment. The Privilege Law does not extend to documents
or information (1) that are generated or developed before the
commencement of a voluntary environmental assessment; (2) that are
prepared independently of the assessment process; (3) that demonstrate a
clear, imminent and substantial danger to the public health or
environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney
General provided a legal opinion that states that the Privilege law, Va.
Code Sec. 10.1-1198,  precludes granting a privilege to documents and
information “required by law,” including documents and information
“required by Federal law to maintain program delegation, authorization
or approval,” since Virginia must (enforce Federally authorized
environmental programs in a manner that is no less stringent than their
Federal counterparts. . . .”   The opinion concludes that
“[r]egarding ( 10.1-1198, therefore, documents or other information
needed for civil or criminal enforcement under one of these programs
could not be privileged because such documents and information are
essential to pursuing enforcement in a manner required by Federal law to
maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o
the extent consistent with requirements imposed by Federal law,” any
person making a voluntary disclosure of information to a state agency
regarding a violation of an environmental statute, regulation, permit,
or administrative order is granted immunity from administrative or civil
penalty.  The Attorney General's January 12, 1998 opinion states that
the quoted language renders this statute inapplicable to enforcement of
any Federally authorized programs, since “no immunity could be
afforded from administrative, civil, or criminal penalties because
granting such immunity would not be consistent with Federal law, which
is one of the criteria for immunity.”, EPA has determined that
Virginia's Privilege and Immunity statutes will not preclude the
Commonwealth from enforcing its program consistent with the Federal
requirements.  In any event, because EPA has also determined that a
state audit privilege and immunity law can affect only state enforcement
and cannot have any impact on Federal enforcement authorities, EPA may
at any time invoke its authority under the CAA, including, for example,
sections 113, 167, 205, 211 or 213, to enforce the requirements or
prohibitions of the state plan, independently of any state enforcement
effort.  In addition, citizen enforcement under section 304 of the CAA
is likewise unaffected by this, or any, state audit privilege or
immunity law.

IV.   Proposed Action

EPA's review of this material indicates that Virginia has met the
requirements for submitting a SIP revision concerning a federally
enforceable state operating permit containing terms and conditions for
the control of emissions of VOCs from the Kraft bakery in Henrico
County, Virginia.  This revision request is for the purpose of meeting
the requirements for RACT in order to implement the maintenance plan for
the Richmond 8-hour ozone maintenance area.  EPA is proposing to approve
Virginia’s SIP revision concerning this state operating permit, which
was submitted on October 29, 2007.  EPA is soliciting public comments on
the issues discussed in this document.  These comments will be
considered before taking final action.

V.  Statutory and Executive Order Reviews

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
proposed action is not a "significant regulatory action" and therefore
is not subject to review by the Office of Management and Budget.  For
this reason, this action is also not subject to Executive Order 13211,
"Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use"  (66 FR 28355 (May 22, 2001)).  This action merely
proposes to approve state law as meeting Federal requirements and
imposes no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this proposed rule will
not have a significant economic impact on a substantial number of small
entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
Because this rule proposes to approve pre-existing requirements under
state law and does not impose any additional enforceable duty beyond
that required by state law, it does not contain any unfunded mandate or
significantly or uniquely affect small governments, as described in the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4).  This proposed
rule also does 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, as specified by
Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132 (64 FR 43255, August 10, 1999),
because it merely proposes to approve a state rule implementing a
Federal requirement, and does not alter the relationship or the
distribution of power and responsibilities established in the CAA.  This
proposed rule also is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because it approves a state rule implementing a Federal
standard.

In reviewing SIP submissions, EPA(s role is to approve state choices,
provided that they meet the criteria of the CAA.  In this context, in
the absence of a prior existing requirement for the State to use
voluntary consensus standards (VCS), EPA has no authority to disapprove
a SIP submission for failure to use VCS.  It would thus be inconsistent
with applicable law for EPA, when it reviews a SIP submission, to use
VCS in place of a SIP submission that otherwise satisfies the provisions
of the CAA.  Thus, the requirements of section 12(d) of the National
Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do
not apply.  As required by section 3 of Executive Order 12988 (61 FR
4729, February 7, 1996), in issuing this proposed rule, EPA has taken
the necessary steps to eliminate drafting errors and ambiguity, minimize
potential litigation, and provide a clear legal standard for affected
conduct.  EPA has complied with Executive Order 12630 (53 FR 8859, March
15, 1988) by examining the takings implications of the rule in
accordance with the (Attorney General(s Supplemental Guidelines for the
Evaluation of Risk and Avoidance of Unanticipated Takings( issued under
the executive order.

This action proposing approval of Virginia’s SIP revision concerning a
federally enforceable State operating permit containing terms and
conditions for the control of emissions of VOCs from the Kraft Foods
Global, Inc. – Richmond Bakery does not impose an information
collection burden under the provisions of the Paperwork Reduction Act of
1995 (44 U.S.C. 3501 et seq.).

List of Subjects in 40 CFR Part 52

Environmental protection, Air pollution control, Ozone, Reporting and
recordkeeping requirements, Volatile organic compounds.

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

___January 23, 2008____________
___________/s/_________________

Dated:                                                      		William T.
Wisniewski, Acting

Regional Administrator,

Region III.

 PAGE

 PAGE   2

 PAGE  10


[Federal Register Volume 85, Number 186 (Thursday, September 24, 2020)]
[Notices]
[Pages 60153-60154]
[FR Doc No: 2020-21106]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP14-347-000; CP19-19-000; CP14-511-000]

Magnolia LNG, LLC; Kinder Morgan Louisiana Pipeline LLC; Notice
of Request for Extension of Time

    Take notice that on September 11, 2020, Magnolia LNG, LLC
(Magnolia) and Kinder Morgan Louisiana Pipeline LLC (KMLP)
(collectively, Applicants) requested that the Federal Energy Regulatory
Commission (Commission) grant an extension of time, until April 15,
2026, to construct and place into service the Magnolia LNG and Lake
Charles Expansion Projects, as authorized in the April 15, 2016 Order
Granting Authorization Under Section 3 of the Natural Gas Act and
Issuing Certificates (April 15, 2016, Order).\1\ The April 15th
Certificate Order required the Applicants to complete construction and
make the facilities available for service within five years of
issuance, or by April 15, 2021.\2\
---------------------------------------------------------------------------

    \1\ Magnolia LNG, LLC, 155 FERC 61,033 (2016), reh'g denied, 157
FERC 61,149 (2016).
    \2\ Id. at ordering paras. (B) and (D)(1).
---------------------------------------------------------------------------

    Magnolia states that global market conditions have impacted
Magnolia's ability to secure long-term offtake contracts and achieve a
final investment decision (FID) and that it is confident that it will
execute commercial agreements that will support a positive FID within
the requested timeframe. KMLP states that construction of the Lake
Charles Expansion Project is dependent upon Magnolia achieving FID for
the Magnolia LNG Project.
    This notice establishes a 15-calendar day intervention and comment
period deadline. Any person wishing to comment on the Applicants'
request for an extension of time may do so. No reply comments or
answers will be considered. If you wish to obtain legal status by
becoming a party to the proceedings for this request, you should, on or
before the comment date stated below, file a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the
Natural Gas Act (18 CFR 157.10).\3\
---------------------------------------------------------------------------

    \3\ Only motions to intervene from entities that were party to
the underlying proceeding will be accepted. Algonquin Gas
Transmission, LLC, 170 FERC 61,144, at P 39 (2020).
---------------------------------------------------------------------------

    As a matter of practice, the Commission itself generally acts on
requests for extensions of time to complete construction for Natural
Gas Act facilities when such requests are contested before order
issuance. For those extension requests that are contested,\4\ the
Commission will aim to issue an order acting on the request within 45
days.\5\ The Commission will address all arguments relating to whether
the applicant has demonstrated there is good cause to grant the
extension.\6\ The Commission will not consider arguments that re-
litigate the issuance of the April 15th Certificate order, including
whether the Commission properly found the project to be in the public
convenience and necessity and whether the Commission's environmental
analysis for the certificate complied with the National Environmental
Policy Act.\7\ At the time a pipeline requests an extension of time,
orders on certificates of public convenience and necessity are final
and the Commission will not re-litigate their issuance.\8\ The OEP
Director, or his or her designee, will act on those extension requests
that are uncontested.
---------------------------------------------------------------------------

    \4\ Contested proceedings are those where an intervenor disputes
any material issue of the filing. 18 CFR 385.2201(c)(1) (2020).
    \5\ Algonquin Gas Transmission, LLC, 170 FERC 61,144, at P 40
(2020).
    \6\ Id. P 40.
    \7\ Similarly, the Commission will not re-litigate the issuance
of an NGA section 3 authorization, including whether a proposed
project is not inconsistent with the public interest and whether the
Commission's environmental analysis for the permit order complied
with NEPA.
    \8\ Algonquin Gas Transmission, LLC, 170 FERC 61,144, at P 40
(2020).
---------------------------------------------------------------------------

    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the

Commission's Home Page (http://ferc.gov) using the eLibrary link. Enter
the docket number excluding the last three digits in the docket number
field to access the document. At this time, the Commission has
suspended access to the Commission's Public Reference Room, due to the
proclamation declaring a National Emergency concerning the Novel
Coronavirus Disease (COVID-19), issued by the President on March 13,
2020. For assistance, contact FERC at<EMAIL_ADDRESS>or
call toll-free,<PHONE_NUMBER> or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFile link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern Time on October 9, 2020.

    Dated: September 18, 2020.
Kimberly D. Bose,
Secretary.
[FR Doc. 2020-21106 Filed 9-23-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Notices]
[Pages 57445-57447]
[FR Doc No: 2019-23308]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2686]

Medical Devices; Exemptions From Premarket Notification: Class II
Devices; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing its intent to exempt a list of class II devices from
premarket notification requirements, subject to certain limitations.
The Agency has determined that, based on established factors, these
devices no longer require premarket notification to provide reasonable
assurance of safety and effectiveness. FDA is publishing this notice to
obtain comments regarding the proposed exemptions, in accordance with
the Federal Food, Drug, and Cosmetic Act (FD&C Act).

DATES: Submit either electronic or written comments on the notice by
December 24, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 24, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 24, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-2686 for ``Medical Devices; Exemptions from Premarket
Notification: Class II Devices; Request for Comments.'' Received
comments, those filed in a timely manner (see

ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jismi Johnson, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1524, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Statutory Background

    Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the
implementing regulations, 21 CFR part 807 subpart E, require persons
who intend to market a new device to submit and obtain clearance of a
premarket notification (510(k)) containing information that allows FDA
to determine whether the new device is ``substantially equivalent''
within the meaning of section 513(i) of the FD&C Act to a legally
marketed device that does not require premarket approval.
    The 21st Century Cures Act (Cures Act) (Pub. L. 114-255) was signed
into law on December 13, 2016. Section 3054 of the Cures Act amended
section 510(m) of the FD&C Act. As amended, section 510(m)(1)(A) of the
FD&C Act requires FDA to publish in the Federal Register a notice
containing a list of each type of class II device that FDA determines
no longer requires a report under section 510(k) of the FD&C Act to
provide reasonable assurance of safety and effectiveness. FDA is
required to publish this notice within 90 days of the date of enactment
of the Cures Act and at least once every 5 years thereafter, as FDA
determines appropriate. Additionally, FDA must provide at least a 60-
day comment period for any such notice required to be published under
section 510(m)(1)(A) of the FD&C Act. FDA published this notice in the
Federal Register of March 14, 2017 (82 FR 13609). Under section
510(m)(1)(B) of the FD&C Act, FDA must publish in the Federal Register,
within 210 days of enactment of the Cures Act, a list representing its
final determination regarding the exemption of the devices that were
contained in the list published under section 510(m)(1)(A). FDA
published that list in the Federal Register of July 11, 2017 (82 FR
31976).
    As amended, section 510(m)(2) of the FD&C Act provides that, 1 day
after the date of publication of the final list under section
510(m)(1), FDA may exempt a class II device from the requirement to
submit a report under section 510(k) of the FD&C Act upon its own
initiative or a petition of an interested person, if FDA determines
that a report under section 510(k) is not necessary to assure the
safety and effectiveness of the device. To do so, FDA must publish in
the Federal Register a notice of its intent to exempt the device, or of
the petition, and provide a 60-day period for public comment. Within
120 days after the issuance of this notice, FDA must publish an order
in the Federal Register that sets forth its final determination
regarding the exemption of the device that was the subject of the
notice. If FDA fails to respond to a petition under section 510(m)(2)
of the FD&C Act within 180 days of receiving it, the petition shall be
deemed granted. FDA is proposing to exempt a list of class II devices
from premarket notification requirements, subject to certain
limitations, upon its own initiative.

II. Factors FDA May Consider for Exemption

    There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1). Accordingly, FDA generally considers
the following factors to determine whether premarket notification is
necessary for class II devices: (1) The device does not have a
significant history of false or misleading claims or of risks
associated with inherent characteristics of the device; (2)
characteristics of the device necessary for its safe and effective
performance are well established; (3) changes in the device that could
affect safety and effectiveness will either (a) be readily detectable
by users by visual examination or other means such as routine testing,
before causing harm, or (b) not materially increase the risk of injury,
incorrect diagnosis, or ineffective treatment; and (4) any changes to
the device would not be likely to result in a change in the device's
classification. FDA may also consider that, even when exempting
devices, these devices would still be subject to the limitations on
exemptions.

III. Limitations on Exemptions

    FDA has determined that premarket notification is not necessary to
assure the safety and effectiveness of the class II devices listed in
table 1. This determination is based, in part, on the Agency's
knowledge of the device, including past experience and relevant reports
or studies on device performance (as appropriate), the applicability of
general and special controls, and the Agency's ability to limit an
exemption.

A. General Limitations of Exemptions

    FDA's proposal to grant an exemption from premarket notification
for class II devices listed in table 1 applies only to those devices
that have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type. FDA proposes
that a manufacturer of a listed device would

still be required to submit a premarket notification to FDA before
introducing a device or delivering it for introduction into commercial
distribution when the device meets any of the conditions described in
21 CFR 884.9 to 21 CFR 890.9.

B. Partial Limitations of Exemptions

    In addition to the general limitations, FDA may also partially
limit an exemption from premarket notification requirements to specific
devices within a listed device type when initial Agency assessment
determines that the factors laid out in the Class II 510(k) Exemption
Guidance (Ref. 1) do not weigh in favor of exemption for all devices in
a particular group. In such situations where a partial exemption
limitation has been identified, FDA has determined that premarket
notification is necessary to provide a reasonable assurance of safety
and effectiveness for these devices. In table 1, for example, FDA is
listing the proposed exemption of the optical position/movement
recording system but limits the exemption to such devices that are for
prescription (Rx) use only. FDA believes that FDA review (e.g.,
premarket notification) of an optical position/movement recording
system for over-the-counter (OTC) use is necessary to ensure that the
exercises and activities led by the system are appropriate for a user's
rehabilitation and to assess the measurement accuracy of the system.
Additionally, a therapeutic massager to internally massage trigger
points in the pelvic floor musculature would exceed the exemption
limitation and would require 510(k) review if it is indicated for OTC
use, lacks a quantitative feedback mechanism, or lacks a disposable
covering.

IV. List of Class II Devices

    FDA is identifying the following list of class II devices that, if
finalized, would no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. Sec.  884.9 to 890.9:

                        Table 1--Class II Devices
------------------------------------------------------------------------
                                                             Partial
                                                            exemption
     21 CFR section         Device type    Product code   limitation (if
                                                           applicable)
------------------------------------------------------------------------
884.6120................  Accessory,       MQG           Exemption is
                           Assisted                       limited to
                           Reproduction.                  assisted
                                                          reproduction
                                                          laminar flow
                                                          workstations.
884.6180................  Media,           MQL           Exemption is
                           Reproductive.                  limited to
                                                          phosphate-
                                                          buffered
                                                          saline used
                                                          for washing,
                                                          and short-term
                                                          handling and
                                                          manipulation
                                                          of gametes and
                                                          embryos;
                                                          culture oil
                                                          used as an
                                                          overlay for
                                                          culture media
                                                          containing
                                                          gametes and
                                                          embryos; and
                                                          water for
                                                          assisted
                                                          reproduction
                                                          applications.
888.4505................  Instruments      QBO           ...............
                           Designed for
                           Press-Fit
                           Osteochondral
                           implants.
890.5360................  System, Optical  LXJ           Exemption is
                           Position/                      limited to
                           Movement                       prescription
                           Recording                      (Rx) use only.
                           (Interactive
                           Rehabilitation
                           Exercise
                           Devices).
890.5670................  Massager,        OSD           Exemption is
                           Therapeutic,                   limited to
                           to Internally                  prescription
                           Massage                        (Rx) use only
                           Trigger Points                 devices which
                           in the Pelvic                  incorporate a
                           Floor                          quantitative
                           Musculature.                   feedback
                                                          mechanism and
                                                          a disposable
                                                          covering.
------------------------------------------------------------------------

    FDA will assign new product codes to the device types that will be
exempt subject to the partial limitations in order to ensure that these
devices can be separated from devices that do not fall within the
partial exemption limitation under the existing product code (i.e.,
exempt and non-exempt devices within a device type will have distinct
product codes).
    FDA is also revising the name of product code LXJ to further
clarify the device type that this product code is intended to
represent. The device type was previously ``System, Optical Position/
Movement Recording.'' This product code also includes types of
rehabilitation devices other than optical position/movement recording
systems; therefore, to more accurately reflect the devices which fall
within this device type (product code LXJ), the device type has been
renamed ``Interactive Rehabilitation Exercise Devices.''

V. Reference

    The following reference is on display in the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA Guidance, ``Procedures for Class II Device Exemptions from
Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at https://www.fda.gov/media/72685/download.

    Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23308 Filed 10-24-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 79, Number 31 (Friday, February 14, 2014)]
[Proposed Rules]
[Pages 8905-8907]
[FR Doc No: 2014-03252]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-0882; Directorate Identifier 2013-NE-29-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG
Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
Rolls-Royce Deutschland Ltd & Co KG (RRD) BR700-725A1-12 turbofan
engines. This proposed AD was prompted by reports of wear on the
receptors of the double-ended unions in the fuel metering unit (FMU)
housing on BR700-725A1-12 engines causing fuel leakage. This proposed
AD would require removal of the affected FMUs. We are proposing this AD
to prevent failure of the FMU, which could lead to damage to one or
more engines and damage to the airplane.

DATES: We must receive comments on this proposed AD by April 15, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this AD, contact Rolls-Royce
Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827 Blankenfelde-
Mahlow, Germany; phone: 49 0 33-7086-1883; fax: 49 0 33-7086-3276. You
may view this service information at the FAA, Engine & Propeller
Directorate, 12 New England Executive Park, Burlington, MA 01803. For
information on the availability of this material at the FAA, call 781-
238-7125.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2013-
0882; 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 mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The street address for the Docket Operations
office (phone:<PHONE_NUMBER>) is the same as the Mail address provided
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Glorianne Niebuhr, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 12
New England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>;
fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2013-0882;
Directorate Identifier 2013-NE-29-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed AD. Using the search
function of the Web site, anyone can find and read the comments in any
of our dockets, including, if provided, the name of the individual who
sent the comment (or signed the comment on behalf of an association,
business, labor union, etc.). You may review the DOT's complete Privacy
Act Statement in the Federal Register published on April 11, 2000 (65
FR 19477-78).

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
AD 2013-0229R1, dated November 21, 2013 (referred to hereinafter as
``the MCAI''), to correct an unsafe condition for the specified
products. The MCAI states:

    Occurrences have been reported of finding wear on the receptors
of the double-ended unions in the Fuel Metering Unit (FMU) housing
on BR700-725A1-12 engines.
    This condition, if not corrected, could lead to fuel leak
resulting in engine in-flight shutdown and consequent reduced
control of the aeroplane.

    Failure of the FMU due to these conditions will result in loss of
thrust control and damage to the engine. You may examine the MCAI in
the AD docket on the Internet at http://www.regulations.gov by
searching for and locating it in Docket No. FAA-2013-0882.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of
Germany, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the European Community, EASA has
notified us of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all information provided by EASA and determined the unsafe
condition exists and is likely to exist or develop on other products of
the same type design. This proposed AD would require removal of the
affected FMUs and their replacement with a part eligible for
installation.

Costs of Compliance

    We estimate that this proposed AD affects 24 RRD turbofan engines
installed on aircraft of U.S. registry. We also estimate that it would
take about 6 hours per engine to comply with this proposed AD. The
average labor rate is $85 per hour. Required parts cost about $293,960
per engine. Based on these figures, we estimate the cost of this
proposed AD on U.S. operators to be $7,067,280.

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 proposed 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 above, 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 a regulatory 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):

Rolls-Royce Deutschland Ltd & Co KG: Docket No. FAA-2013-0882;
Directorate Identifier 2013-NE-29-AD.

(a) Comments Due Date

    We must receive comments by April 15, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce Deutschland Ltd & Co KG (RRD)
BR700-725A1-12 turbofan engines.

(d) Reason

    This AD was prompted by reports of wear on the receptors of the
double-ended unions in the fuel metering unit (FMU) housing on
BR700-725A1-12 engines causing fuel leakage. We are issuing this AD
to prevent failure of the FMU, which could lead to damage to one or
more engines, and damage to the airplane.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) After the effective date of this AD, before the FMU has
accumulated 650 flight hours (FHs) since new, or within 30 days,
whichever occurs later, remove FMU part number (P/N) G3000FMU02 or
P/N G3000FMU03, and replace it with a part eligible for
installation.
    (2) Thereafter, remove the FMU at intervals not to exceed 650
FHs and replace it with a part eligible for installation.

(f) Installation Prohibition

    After the effective date of this AD, do not install FMU P/N
G3000FMU02 onto any engine, or install any engine with FMU P/N
G3000FMU02 onto any airplane.

(g) Definition

    For the purpose of this AD, an FMU eligible for installation is
a new FMU or an FMU with P/N G3000FMU03 that has accumulated fewer
than 650 FHs since installation on any airplane or since last repair
using RRD Alert Non-Modification Service Bulletin (NMSB) No. ALERT
SB-BR700-73-A900309, Revision 1, dated November 8, 2013.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, may approve AMOCs for
this AD. Use the procedures found in 14 CFR 39.19 to make your
request.

(i) Related Information

    (1) For more information about this AD, contact Glorianne
Niebuhr, Aerospace Engineer, Engine Certification Office, FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2013-
0229R1, dated November 21, 2013. You may examine the MCAI in the AD
docket on the Internet at http://www.regulations.gov by searching
for and locating it in Docket No. FAA-2013-0882.
    (3) RRD Alert NMSB No. ALERT SB-BR700-73-A900309, Revision 1,
dated November 8, 2013, which is not incorporated by reference in
this AD, can be obtained from RRD, using the contact information in
paragraph (i)(4) of this AD.
    (4) For service information identified in this AD, contact
Rolls-Royce Deutschland Ltd & Co KG, Eschenweg 11, Dahlewitz, 15827
Blankenfelde-Mahlow, Germany; phone: 49 0 33-7086-1944; fax: 49 0
33-7086-3276.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on February 6, 2014.
Colleen M. D'Alessandro,
Assistant Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2014-03252 Filed 2-13-14; 8:45 am]
BILLING CODE 4910-13-P