[Federal Register Volume 81, Number 103 (Friday, May 27, 2016)]
[Proposed Rules]
[Pages 33606-33609]
[FR Doc No: 2016-12497]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Proposed
Rules

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 29

[Docket No. FAA-2016-6939; Notice No. 29-038-SC]

Special Conditions: Bell Helicopter Textron, Inc. (BHTI), Model
525 Helicopters; Interaction of Systems and Structures

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed special conditions.

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SUMMARY: We propose special conditions for the BHTI Model 525
helicopter. This helicopter will have a novel or unusual design feature
associated with fly-by-wire flight control system (FBW FCS) functions
that affect the structural integrity of the rotorcraft. The applicable
airworthiness regulations do not contain adequate or appropriate safety
standards for this design feature. These proposed special conditions
contain the additional safety standards that the Administrator
considers necessary to establish a level of safety equivalent to that
established by the existing airworthiness standards.

DATES: Send your comments on or before July 11, 2016.

ADDRESSES: Send comments identified by docket number FAA-2016-6939]
using any of the following methods:
    [square] Federal eRegulations Portal: Go to http://www.regulations.gov and follow the online instructions for sending your
comments electronically.
    [square] Mail: Send comments to Docket Operations, M-30, U.S.
Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room
W12-140, West Building Ground Floor, Washington, DC 20590-0001.
    [square] Hand Delivery of Courier: Take comments to Docket
Operations in Room W12-140 of the West Building Ground Floor at 1200
New Jersey Avenue SE., Washington, DC, between 8 a.m., and 5 p.m.,
Monday through Friday, except Federal holidays.
    [square] Fax: Fax comments to Docket Operations at<PHONE_NUMBER>.
    Privacy: The FAA will post all comments it receives, without
change, to http://www.regulations.gov, including any personal
information the commenter provides. Using the search function of the
docket Web site, anyone can find and read the electronic form of all
comments received into any FAA docket, including the name of the
individual sending the comment (or signing the comment for an
association, business, labor union, etc.). DOT's complete Privacy Act
Statement can be found in the Federal Register published on April 11,
2000 (65 FR 19477-19478), as well as at http://DocketsInfo.dot.gov.
    Docket: Background documents or comments received may be read at
http://www.regulations.gov at any time. Follow the online instructions
for accessing the docket or go to the Docket Operations in Room W12-140
of the West Building Ground Floor at 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m., and 5 p.m., Monday through Friday,
except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Martin R. Crane, Aviation Safety
Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101
Hillwood Pkwy, Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite interested people to take part in this rulemaking by
sending written comments, data, or views. The most helpful comments
reference a specific portion of the special conditions, explain the
reason for any recommended change, and include supporting data.
    We will consider all comments we receive on or before the closing
date for comments. We will consider comments filed late if it is
possible to do so without incurring expense or delay. We may change
these special conditions based on the comments we receive.

Background

    On December 15, 2011, BHTI applied for a type certificate for a new
transport category helicopter designated as the Model 525. The aircraft
is a medium twin engine rotorcraft. The design maximum takeoff weight
is 20,000 pounds, with a maximum capacity of 16 passengers and a crew
of 2.
    The BHTI Model 525 helicopter will be equipped with a FBW FCS. The
control functions of the FBW FCS and its related systems affect the
structural integrity of the rotorcraft. Current regulations do not take
into account loads for the rotorcraft due to the effects of systems on
structural performance including normal operation and failure
conditions with strength levels related to probability of occurrence.
Special conditions are needed to account for these features.

Type Certification Basis

    Under the provisions of 14 CFR 21.17, BHTI must show that the Model
525 helicopter meets the applicable provisions of part 29, as amended
by Amendment 29-1 through 29-55 thereto. The BHTI Model 525
certification basis date is December 15, 2011, the date of application
to the FAA.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 29) do not contain adequate or
appropriate safety standards for the BHTI Model 525 because of a novel
or unusual design feature, special conditions are prescribed under the
provisions of Sec.  21.16.
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same or similar
novel or unusual design feature, the special conditions would also
apply to the other model under Sec.  21.101.
    In addition to the applicable airworthiness regulations and special
conditions, the BHTI Model 525 helicopter must comply with the noise
certification requirements of 14 CFR part 36, and the FAA must issue a
finding of regulatory adequacy under Sec.  611 of Public Law 92-574,
the ``Noise Control Act of 1972.''
    The FAA issues special conditions, as defined in 14 CFR 11.19, in
accordance with Sec.  11.38, and they become part of the type-
certification basis under Sec.  21.17(a)(2).

Novel or Unusual Design Features

    The BHTI Model 525 helicopter will incorporate the following novel
or unusual design features: FBW FCS, and

its related systems (stability augmentation system, load alleviation
system, flutter control system, and fuel management system), with
control functions that affect the structural integrity of the
rotorcraft. Current regulations are inadequate for considering the
effects of these systems and their failures on structural performance.
The general approach of accounting for the effect of system failures on
structural performance would be extended to include any system where
partial or complete failure, alone or in combination with any other
system's partial or complete failure, would affect structural
performance.

Discussion

    Active flight control systems are capable of providing automatic
responses to inputs from sources other than the pilots. Active flight
control systems have been expanded in function, effectiveness, and
reliability to the point that FBW FCS systems are being installed on
new rotorcraft. As a result of these advancements in flight control
technology, 14 CFR part 29 does not provide a basis to achieve an
acceptable level of safety for rotorcraft so equipped. Certification of
these systems requires issuing special conditions under the provisions
of Sec.  21.16.
    In the past, traditional rotorcraft flight control system designs
have incorporated power-operated systems, stability or control
augmentation with limited control authority, and autopilots that were
certificated partly under Sec.  29.672 with guidance from Advisory
Circular 29-2C, Section AC 29.672. These systems are integrated into
the primary flight controls and are given sufficient control authority
to maneuver the rotorcraft up to its structural design limits in 14 CFR
part 29 subparts C and D. The FBW FCS advanced technology with its full
authority necessitates additional requirements to account for the
interaction of control systems and structures.
    The regulations defining the loads envelope in 14 CFR part 29 do
not fully account for the effects of systems on structural performance.
Automatic systems may be inoperative or they may operate in a degraded
mode with less than full system authority and associated built-in
protection features. Therefore, it is necessary to determine the
structural factors of safety and operating margins such that the
probability of structural failures due to application of loads during
FBW FCS malfunctions is not greater than that found in rotorcraft
equipped with traditional flight control systems. To achieve this
objective and to ensure an acceptable level of safety, it is necessary
to define the failure conditions and their associated frequency of
occurrence.
    Traditional flight control systems provide two states, either fully
functioning or completely inoperative. These conditions are readily
apparent to the flight crew. Newer active flight control systems have
failure modes that allow the system to function in a degraded mode
without full authority and associated built-in protection features. As
these degraded modes are not readily apparent to the flight crew,
monitoring systems are required to provide an annunciation of degraded
system capability.

Applicability

    As discussed above, these special conditions are applicable to the
BHTI Model 525 helicopter. Should BHTI apply at a later date for a
change to the type certificate to include another model incorporating
the same novel or unusual design feature, the special conditions would
apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of rotorcraft. It is not a rule of general applicability.

List of Subjects in 14 CFR Part 29

    Aircraft, Aviation safety, Reporting and recordkeeping
requirements.

    The authority citation for these special conditions is as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701, 44702, 44704.

The Proposed Special Conditions

    Accordingly, the Federal Aviation Administration (FAA) proposes the
following special conditions as part of the type certification basis
for Bell Helicopter Textron, Inc., Model 525 helicopters:

Interaction of Systems and Structures

    For rotorcraft equipped with systems that affect structural
performance, either directly or as a result of a failure or
malfunction, the influence of these systems and their failure
conditions must be taken into account when showing compliance with the
requirements of Title 14, Code of Federal Regulations (14 CFR) part 29
subparts C and D.
    The following criteria must be used for showing compliance with
these special conditions for rotorcraft equipped with FCSs, autopilots,
stability augmentation systems, load alleviation systems, flutter
control systems, fuel management systems, and other systems that either
directly or as a result of failure or malfunction affects structural
performance. If these special conditions are used for other systems, it
may be necessary to adapt the criteria to the specific system.
    (a) The criteria defined herein only address the direct structural
consequences of the system responses and performance. They cannot be
considered in isolation but should be included in the overall safety
evaluation of the rotorcraft. These criteria may in some instances
duplicate standards already established for this evaluation. These
criteria are only applicable to structure whose failure could prevent
continued safe flight and landing. Specific criteria that define
acceptable limits on handling characteristics or stability requirements
when operating in the system degraded or inoperative mode are not
provided in these special conditions.
    (b) Depending upon the specific characteristics of the rotorcraft,
additional studies may be required that go beyond the criteria provided
in this special condition in order to demonstrate the capability of the
rotorcraft to meet other realistic conditions such as alternative gust
or maneuver descriptions for a rotorcraft equipped with a load
alleviation system.
    (c) The following definitions are applicable to these special
conditions:
    (1) Structural performance: Capability of the rotorcraft to meet
the structural requirements of 14 CFR part 29.
    (2) Flight limitations: Limitations that can be applied to the
rotorcraft flight conditions following an in-flight occurrence and that
are included in the flight manual (e.g., speed limitations and
avoidance of severe weather conditions).
    (3) Operational limitations: Limitations, including flight
limitations, which can be applied to the rotorcraft operating
conditions before dispatch (e.g., fuel, payload, and Master Minimum
Equipment List limitations).
    (4) Probabilistic terms: The terms ``improbable'' and ``extremely
improbable'' are the same as those used in Sec.  29.1309.
    (5) Failure condition: The term ``failure condition'' is the same
as that used in Sec.  29.1309; however, these special conditions apply
only to system failure conditions that affect the structural
performance of the rotorcraft (e.g., system failure conditions that
induce loads, change the response of the rotorcraft to inputs such as
gusts or pilot actions, or lower flutter margins).

Effects of Systems on Structures

    (a) General. The following criteria will be used in determining the
influence of a system and its failure conditions on the rotorcraft
structure.
    (b) System fully operative. With the system fully operative, the
following apply:
    (1) Limit loads must be derived in all normal operating
configurations of the system from all the limit conditions specified in
Subpart C (or defined by special condition or equivalent level of
safety in lieu of those specified in Subpart C), taking into account
any special behavior of such a system or associated functions or any
effect on the structural performance of the rotorcraft that may occur
up to the limit loads. In particular, any significant nonlinearity
(rate of displacement of control surface, thresholds or any other
system nonlinearities) must be accounted for in a realistic or
conservative way when deriving limit loads from limit conditions.
    (2) The rotorcraft must meet the strength requirements of part 29
(static strength, residual strength), using the specified factors to
derive ultimate loads from the limit loads defined above. The effect of
nonlinearities must be investigated beyond limit conditions to ensure
the behavior of the system presents no anomaly compared to the behavior
below limit conditions. However, conditions beyond limit conditions
need not be considered when it can be shown that the rotorcraft has
design features that will not allow it to exceed those limit
conditions.
    (3) The rotorcraft must meet the flutter and divergence
requirements of Sec.  29.629.
    (c) System in the failure condition. For all system failure
conditions shown to be not extremely improbable, the following apply:
    (1) At the time of occurrence. Starting from 1-g level flight
conditions, a realistic scenario, including pilot corrective actions,
must be established to determine the loads occurring at the time of
failure and immediately after the failure.
    (i) For static strength substantiation, these loads multiplied by
an appropriate factor of safety that is related to the probability of
occurrence of the failure are the ultimate loads that must be
considered for design. The factor of safety is defined in Figure 1.
[GRAPHIC] [TIFF OMITTED] TP27MY16.018

    (ii) For residual strength substantiation, the rotorcraft must be
able to withstand two-thirds of the ultimate loads defined in paragraph
(c)(1)(i) of these special conditions.
    (iii) Freedom from flutter and divergence must be shown under all
conditions of operation including:
    (A) Airspeeds up to 1.11 VNE (power on and power off).
    (B) Main rotor speeds from 0.95 multiplied by the minimum permitted
speed up to 1.05 multiplied by the maximum permitted speed (power on
and power off).
    (C) The critical combinations of weight, center of gravity
position, load factor, and altitude.
    (iv) For failure conditions that result in excursions beyond
operating limitations, freedom from flutter and divergence must be
shown to increased speeds, so that the margins intended by paragraph
(c)(1)(iii) of these special conditions are maintained.
    (v) Failures of the system that result in forced structural
vibrations (oscillatory failures) must not produce loads that could
result in detrimental deformation of primary structure.
    (2) For the continuation of the flight. For the rotorcraft in the
system failed state, and considering all appropriate reconfiguration
and flight limitations, the following apply:
    (i) The loads derived from the following conditions (or defined by
special conditions or equivalent level of safety in lieu of the
following conditions) at speeds up to VNE (power on and
power off) (or the speed limitation prescribed for the remainder of the
flight) and at the minimum and maximum main rotor speeds, if
applicable, must be determined:
    (A) The limit maneuvering conditions specified in Sec. Sec.  29.337
and 29.339.
    (B) The limit gust conditions specified in Sec.  29.341.
    (C) The limit yaw maneuvering conditions specified in Sec.  29.351.
    (D) The limit unsymmetrical conditions specified in Sec.  29.427.
    (E) The limit ground loading conditions specified in Sec.  29.473.
    (ii) For static strength substantiation, each part of the structure
must be able to withstand the loads in paragraph (c)(2)(i) of these
special conditions multiplied by a factor of safety depending on the
probability of being in this failure state. The factor of safety is
defined in Figure 2.

[GRAPHIC] [TIFF OMITTED] TP27MY16.019

Qj = (Tj)(Pj)

Where:

Tj = Average time spent in failure condition j (in hours)
Pj = Probability of occurrence of failure mode j (per
hour)

    Note:  If Pj is greater than 10-\3\ per
flight hour, then a 1.5 factor of safety must be applied to all
limit load conditions specified in Subpart C.

    (iii) For residual strength substantiation, the rotorcraft must be
able to withstand two-thirds of the ultimate loads defined in paragraph
(c)(2)(ii) of these special conditions.
    (iv) If the loads induced by the failure condition have a
significant effect on fatigue or damage tolerance, then their effects
must be taken into account.
    (v) Freedom from flutter and divergence must be shown up to 1.11
VNE (power on and power off).
    (vi) Freedom from flutter and divergence must also be shown up to
1.11 VNE (power on and power off) for all probable system
failure conditions combined with any damage required or considered
under Sec.  29.571(g) or Sec.  29.573(d)(3).
    (3) Consideration of certain failure conditions may be required by
other sections of 14 CFR part 29 regardless of calculated system
reliability. Where the failure analysis shows the probability of these
failure conditions to be less than 10-\9\, criteria other
than those specified in this paragraph may be used for structural
substantiation to show continued safe flight and landing.
    (d) Failure indications. For system failure detection and
indication, the following apply:
    (1) The system must be checked for failure conditions, not
extremely improbable, that degrade the structural capability below the
level required by 14 CFR part 29 or that significantly reduce the
reliability of the remaining operational portion of the system. As far
as reasonably practicable, the flight crew must be made aware of these
failures before flight. Certain elements of the control system, such as
mechanical and hydraulic components, may use special periodic
inspections, and electronic components may use daily checks, in lieu of
detection and indication systems to achieve the objective of this
requirement. These other means of detecting failures before flight will
become part of the certification maintenance requirements (CMRs) and
must be limited to components that are not readily detectable by normal
detection and indication systems, and where service history shows that
inspections will provide an adequate level of safety.
    (2) The existence of any failure condition, shown to be not
extremely improbable, during flight that could significantly affect the
structural capability of the rotorcraft and for which the associated
reduction in airworthiness can be minimized by suitable flight
limitations, must be signaled to the flight crew. For example, failure
conditions that result in a factor of safety between the rotorcraft
strength and the loads of Subpart C below 1.25, or flutter and
divergence margins below 1.11 VNE (power on and power off),
must be signaled to the crew during flight.
    (e) Dispatch with known failure conditions. If the rotorcraft is to
be dispatched in a known system failure condition that affects
structural performance, or that affects the reliability of the
remaining operational portion of the system to maintain structural
performance, then the provisions of these special conditions must be
met, including the provisions of paragraph (b) for the dispatched
condition and paragraph (c) for subsequent failures. Expected
operational limitations may be taken into account in establishing
Pj as the probability of failure occurrence for determining
the safety margin in Figure 1 of these special conditions. Flight
limitations and expected operational limitations may be taken into
account in establishing Qj as the combined probability of
being in the dispatched failure condition and the subsequent failure
condition for the safety margins in Figure 2 of these special
conditions. These limitations must be such that the probability of
being in this combined failure state and then subsequently encountering
limit load conditions is extremely improbable. No reduction in these
safety margins is allowed if the subsequent system failure rate is
greater than 10-\3\ per hour.

    Issued in Fort Worth, Texas, on May 18, 2016.
Jorge Castillo,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2016-12497 Filed 5-26-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 184 (Friday, September 21, 2018)]
[Notices]
[Pages 47949-47950]
[FR Doc No: 2018-20592]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736

Extension:
    Rule 17Ad-15; SEC File No. 270-360, OMB Control No. 3235-0409

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17Ad-15 (17 CFR
240.17Ad-15) under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.). The Commission plans to submit this existing collection of
information to the Office of Management and Budget (``OMB'') for
extension and approval.
    Rule 17Ad-15 (17 CFR 240.17Ad-15) under the Securities Exchange Act
of 1934 (15 U.S.C. 78a et seq.) (the ``Act'')

requires the approximately 373 registered transfer agents to establish
written standards for the acceptance or rejection of guarantees of
securities transfers from eligible guarantor institutions. Transfer
agents are required to establish procedures to ensure that those
standards are used by the transfer agent to determine whether to accept
or reject guarantees from eligible guarantor institutions. Transfer
agents must maintain, for a period of three years following the date of
a rejection of transfer, a record of all transfers rejected, along with
the reason for the rejection, identification of the guarantor, and
whether the guarantor failed to meet the transfer agent's guarantee
standard. These recordkeeping requirements assist the Commission and
other regulatory agencies with monitoring transfer agents and ensuring
compliance with the rule.
    There are approximately 373 registered transfer agents. The staff
estimates that each transfer agent will spend about 40 hours annually
to comply with Rule 17Ad-15, or a total of 14,920 hours for all
transfer agents (373 x 40 hours = 14,920 hours). The Commission staff
estimates that compliance staff work at each registered transfer agent
will result in an internal cost of compliance (at an estimated hourly
wage of $283) of $11,320 per year per transfer agent (40 hours x $283
per hour = $11,320 per year). Therefore, the aggregate annual internal
cost of compliance for the approximately 373 registered transfer agents
is approximately $4,222,360 ($11,320 x 373 = $4,222,360).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information on
respondents; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted in
writing within 60 days of this publication.
    An Agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Director/
Chief Information Officer, Securities and Exchange Commission, c/o
Candace Kenner, 100 F Street NE, Washington, DC 20549, or send an email
to: [email protected].

    Dated. September 18, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-20592 Filed 9-20-18; 8:45 am]
 BILLING CODE 8011-01-P


OVERVIEW OF FENARIMOL RISK ASSESSMENT Introduction This document presents an overview of EPA's human health findings and conclusions for the fungicide fenarimol, as presented fully in the documents:" Fenarimol: HED Human Health Assessment for the Tolerance Reassessment Eligibility Decision ( TRED)," dated February 12, 2002, and " Drinking Water Assessment to Support TRED for fenarimol," dated August 6, 2001. The purpose of this overview is to assist the reader by identifying the key features and findings of this risk reassessment in order to better understand the conclusions reached in the tolerance reassessment. This overview was developed in response to comments and requests from the public, which indicated that the risk assessments were difficult to understand, that they were too lengthy, and that it was not easy to compare the assessments for different chemicals due to the use of different formats.

The Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996, requires EPA to review all the tolerances for registered chemicals in effect on or before the date of the enactment of FQPA. In reviewing these tolerances, the Agency must consider, among other things, aggregate risks from non occupational sources of pesticide exposure, whether there is increased susceptibility to infants and children, and the cumulative effects of pesticides with a common mechanism of toxicity. The tolerances are considered reassessed once the safety finding has been made or a revocation occurs.

FQPA stipulates that when determining the safety of a pesticide chemical, EPA shall base its assessment of the risk posed by the chemical on, among other things, available information concerning the cumulative effects to human health that may result from dietary, residential, or other non occupational exposure to other substances that have a common mechanism of toxicity. The reason for consideration of other substances is due to the possibility that low level exposures to multiple chemical substances that cause a common toxic effect by a common mechanism could lead to the same adverse health effect as would a higher level of exposure to any of the substances individually. A person exposed to a pesticide at a level that is considered safe may in fact experience harm if that person is also exposed to other substances that cause a common toxic effect by a mechanism common with that of the subject pesticide, even if the individual exposure levels to the other substances are also considered safe.

EPA did not perform a cumulative risk assessment as part of the Tolerance Reassessment Decision ( TRED) for fenarimol because the Agency has not yet initiated a comprehensive review to determine if there are any other chemical substances that have a mechanism of toxicity common with that of fenarimol. For purposes of this risk assessment, EPA has assumed that fenarimol does not have a common mechanism of toxicity with other substances. In the future, the registrant may be asked to submit, upon EPA's request and according to 2 a schedule determined by the Agency, such information as the Agency directs to be submitted in order to evaluate issues related to whether fenarimol shares a common mechanism of toxicity with any other substance and, if so, whether any tolerances for fenarimol need to be modified or revoked. The Agency has developed a framework for conducting cumulative risk assessments on substances that have a common mechanism of toxicity. This guidance was issued on January 16, 2002 ( 67 FR 2210 2214) and is available from the OPP Website at: http:// www. epa. gov/ pesticides/ trac/ science/ cumulative_ guidance. pdf.

The risk assessment, and documents pertaining to the Agency's report on FQPA tolerance reassessment progress and risk management decision for fenarimol are available on the Internet at http:// www. epa. gov/ pesticides/ reregistration/ status. htm and in the public docket for viewing. The Agency's report on FQPA tolerance reassessment progress and risk management decision for fenarimol will be announced in the Federal Register.

Use Profile $ Fungicide: Fenarimol is registered for treatment of apples, bananas, cherries, filberts, grapes, pears, pecans. It is also registered for use on ornamental plants, trees, and residential/ recreational turf. Fenarimol is a systemic fungicide that inhibits fungal growth.

$ Formulations: Formulated as flowable concentrate ( 2.4% ai), granular ( 0.78% ai, turf use only), soluble concentrate ( 11.6% ai), and emulsifiable concentrates ( 12% ai).

$ Methods of Application: Granules can be applied by hand or by granule applicator ( belly grinder, push type spreader). Other formulations are applied by high or low volume ground sprayers.

$ Use Rates: The maximum rate for fruit and nut trees is 0.09375 lb ai/ A. The maximum rate for ornamentals is 0.34 lb/ 350 gal. The maximum rate for turf is 2.73 lb ai/ A.

$ Registrants: Gowan Company, Riverdale, and Leesco.

$ Use Summary: Total annual domestic use averages approximately 61,000 thousand pounds of active ingredient. The largest markets, in terms of total pounds active ingredient are apples ( 33%), nursery outdoors ( 20%), turf for lawn ( 16%), and turf for golf courses ( 12%). The remaining usage is primarily on raisin and wine grapes, almonds, cherries, hazelnuts, and pears. Crops with a high percentage of the total U. S. planted acres treated include apples ( 25%), sweet cherries ( 13%), tart cherries, wine grapes, and hazelnuts ( 9% each), and table grapes ( 8%). 3 Human Health Risk Assessment Acute Dietary Risk ( Food)

No appropriate endpoint was identified in the toxicological data base to estimate risk from a single dose administration of fenarimol. Therefore, an acute dietary exposure assessment was not performed.

Chronic Dietary Risk ( Food)

( For a complete discussion, see section 4.2 of the Human Health Risk Assessment)

Chronic dietary risk is calculated by using the average consumption value for food and average residue values on those foods over a 70 year lifetime. A risk estimate that is less than 100% of the chronic RfD ( the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected) does not exceed the Agency's level of concern. The cPAD is the chronic reference dose ( cRfD) adjusted for the FQPA Safety Factor.

Chronic risk estimates from exposures to food do not exceed the Agency's level of concern. The chronic dietary ( food only) risk estimate is < 1% of the cPAD, for the U. S. Population and all subpopulations. This is not surprising based on: the lack of detectable residues for many commodities in the FDA monitoring data; no residues expected in milk, poultry and hogs; and, low anticipated residues for cattle meat, fat, and meat by products.

$ The toxicity endpoint for the chronic dietary assessment is decreased live born litter size in the F 1 and F 2 generations based on the results of a rat reproduction study ( NOAEL = 0.6 mg/ kg/ day). These effects were observed at 1.2 mg/ kg/ day ( LOAEL).

$ The Uncertainty Factor is 100x; 10x for inter species variation and 10x for intra species extrapolation.

$ The 10x FQPA Safety Factor has been reduced to 3x for chronic exposure scenarios to account for the potential increased sensitivity of young organisms to the hormonal effects elicited by fenarimol's inhibition of aromatase.

$ The chronic dietary exposure assessment for fenarimol is highly refined using anticipated residues based on 1996 1999 Food and Drug Administration ( FDA) monitoring data for apples, bananas, cherries, grapes and pears. Field trial residue data were used for pecans and filberts. Percent crop treated (% CT) information and processing factors, where 4 available, were used. There were no PDP monitoring data available for fenarimol.

$ The chronic Population Adjusted Dose ( cPAD) is 0.002 mg/ kg/ day ( chronic RfD 0.006 mg/ kg/ day ÷ 3x FQPA safety factor).

$ Drinking Water Dietary Risk ( For a complete discussion, see section 4.3 of the Human Health Risk Assessment)

Drinking water exposure to pesticides can occur through groundwater and surface water contamination. EPA considers both acute ( one day) and chronic ( lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. To determine the maximum allowable contribution of treated water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food, then calculates a " drinking water level of comparison" ( DWLOC) to determine whether modeled or monitoring concentrations exceed this level.

The DWLOCs represent the maximum contribution to the human diet ( in ppb or µ g/ L) that may be attributed to residues of a pesticide in drinking water after dietary exposure is subtracted from the aPAD or cPAD. Risks from drinking water are assessed by comparing the DWLOCs to the estimated environmental concentrations ( EECs) in surface water and groundwater. Drinking water modeling is considered to be an unrefined assessment and provides high end estimates. Modeling provides a screening level assessment, using conservative assumptions to estimate high end average concentrations ( EECs) of fenarimol in surface water and groundwater.

$ An acute toxicity endpoint was not identified, therefore, an acute drinking water exposure assessment was not required.

$ Comparison of the chronic DWLOCs with the chronic EECs, average concentrations of fenarimol in surface water are greater than the DWLOCs for all populations indicating a concern based on the application rate to turf.

$ The chronic surface water value of 84 ppb includes all residential uses and the golf course use of fenarimol. However, with the residential uses removed from the label a correction factor of .31 can be applied to the 84 ppb surface water number to account for the use of fenarimol only on tees, greens, and fairways on golf courses. This would reduce the chronic EEC to 26 ppb.

$ For groundwater, the EECs are below the DWLOCs for all populations indicating that chronic exposure to fenarimol in ground water is not of concern. 5 Table 1 Fenarimol  Comparison of Chronic DWLOC and EEC Calculations ( turf uses)

Population Subgroup Chronic DWLOC Estimated Environmental Concentrations Surface Water ( Chronic) ( ppb) Ground Water ( SCI GROW) ( ppb)

U. S. Population 70 ppb 84 ppb ( with residential and golf course turf uses)

26 ppb ( with residential uses removed and only golf course use remaining) 16 Females 13  50 yrs 60 ppb Children 1 6 yrs 20 ppb All Infants 20 ppb $ Estimated drinking water concentrations for ground water are based on the SCI GROW model, which is a Tier I assessment that provides a high end estimate.

$ Estimated drinking water concentrations for surface water are based on the FIRST model, which is a Tier I assessment that also provides a high end estimate.

$ The use of fenarimol on turf was modeled for both ground water and surface water. The turf use has the highest application rate of 2.7 lbs ai/ A. The turf use comprises 28% or approximately 17,000 lbs of the total fenarimol use of 61,000 lbs applied annually. About 9800 lbs are used on lawns and about 7000 lbs are used on golf course turf.

$ Model estimates can be refined when additional fate data become available.

$ For chronic risk to surface water, the EEC of 84 ppb is above the chronic DWLOCs of 70 ppb for general population, 60 ppb for females 13 50 years old, and 20 ppb for infants and children 1 6 years, indicating that chronic exposure to fenarimol in surface water may be of concern for residential turf uses.

$ Removing the residential turf uses from the labels and with only the golf course use remaining would reduce the chronic surface water DWLOC to 26 ppb.

$ Surface water modeling for drinking water uses a percent cropped area factor ( PCA). The PCA represents the fraction of a watershed that is cropped and treated with the pesticide being modeled. In the absence of having a PCA factor for a particular crop a default PCA of 0.87 is used. The 0.87 factor represents the maximum fraction of a watershed in the US that is agriculturally cropped. Given the relatively low usage of fenarimol across the country it is highly unlikely that the amount applied to the watershed in the model will be concentrated in any real watershed used to derive drinking water.

$ For chronic risk to groundwater, the EEC of 16 is below the chronic DWLOCs of 70 ppb for general population, 60 ppb for females 13 50 years old, and 20 ppb for infants and children 1 6 years, indicating that chronic exposure to fenarimol in ground water is not of 6 concern.

$ Additional data are being required that will provide important information on the mobility of fenarimol and its degradates. These studies will help refine the assessment.

$ Very limited water monitoring data are available for fenarimol.

Residential Risk The registrants have agreed to add prohibitions on the labels indicating that fenarimol products are not for use or sale to homeowners. Also, the registrants have agreed to delete residential uses from end use labels until data are developed to further clarify potential risk to children. The following summary is provided to outline the rationale for deleting this use as an interim mitigation measure.

Residential Postapplication Risk $ For the short term ( 1 30 day) incidental oral, dermal, and inhalation risk assessments, a LOAEL of 35 mg/ kg/ day was selected. This endpoint is based on decreased fertility and dystocia ( difficult labor), an indicator of hormonal effects, observed in a special nonguideline cross breeding reproduction/ developmental toxicity study in rats. Because a LOAEL is used an additional 3x uncertainty factor was applied in addition to the 10x interspecies, 10x intraspecies, and 3x FQPA factor. A Margin of Exposure or MOE, which is the ratio of the NOAEL to the exposure estimate, of greater than 900 does not exceed the Agency's level of concern for these risk assessments.

$ Increasing the minimum retreatment interval on residential/ recreational turf from 7 to 30 days would eliminate the residential postapplication intermediate term exposure scenarios. This is based on chemical specific data from a turf transferable residue ( TTR) study which estimates that the dissipation of fenarimol is approximately 8% per day.

$ Only short term risks from residential postapplication dermal and incidental oral exposures are anticipated and were estimated for fenarimol. No intermediate or long term exposure scenarios are anticipated due to proposed labeling changes. Postapplication inhalation exposures are not anticipated because the vapor pressure of fenarimol is low ( 2.2 x 10 7 mmHg).

$ A 5% dermal absorption factor was derived from a monkey study. Dermal absorption rates of 1.36%, 2.32%, 3.12% and 4.12% ( mean 2.73% ± 1.17%) were observed for the four individual monkeys. However, from 8 to 29% of the dermally applied radioactivity was not accounted for. Since there was variation in the dermal absorption in the four monkeys and there was radioactivity not accounted for, a value of 5% is appropriate.

$ The scenarios assessed for the purpose of determining risk estimates included adults and 7 children performing high contact play or work activities on treated lawns, and adults mowing lawns or golfing. Small children ( toddlers) were also assessed for incidental oral exposure from hand to mouth activities while playing on a treated lawn. Some of these exposures were combined, where it was deemed reasonably likely that activities would cooccur

$ Risk estimates for short term dermal contact with treated turf during high contact lawn activities ( e. g. playing) on day zero following application exceed the Agency's estimated level of concern, i. e. result in MOEs < 900 for children ( MOE = 660). Risk estimates for short term dermal contact with fenarimol residues on treated turf on the day of treatment do not exceed the level of concern for adults during the low contact activities of grass mowing ( MOE = 27,000) or golfing ( MOE = 14,000).

$ EPA assessed short term exposure of small children from incidental episodic ingestion of fenarimol granules following application to residential lawns. The risk calculations indicate that ingestion of fenarimol granules ( MOE = 220) exceed the level of concern ( MOEs < 900). However, EPA considers the incidental episodic risk of ingestion of fenarimol granules to be unlikely given the small particle size of fenarimol granules and the low percentage of active ingredient ( 0.78%). Approximately 93% of the product has a particle diameter range of 0.594 to 0.841 mm, with the remaining 7% in the 0.841 to 2 mm size. The granules are white in color. If evenly distributed, individual grains would be difficult to pick up, or even to see when applied on a lawn. Therefore, this product would be difficult for a small child to grasp and then mouth or ingest.

$ EPA also assessed short term exposures to small children from incidental episodic ingestion of residues following application to residential lawns. The risk calculations for small children's non dietary hand to mouth activities ( MOE = 860) indicate that risks exceed the level of concern ( MOEs < 900). Incidental ingestion of soil ( MOE = 260,000) and incidental turfgrass mouthing ( MOE = 3400) did not exceed the level of concern ( MOEs < 900). The small children's combined oral hand to mouth scenarios ( except granular ingestion) also exceeds the level of concern ( MOE = 690). When risk estimates to small children from short term dermal exposures are combined with risk estimates from all incidental oral exposures ( except episodic ingestion of fenarimol granules) the combined short term risk estimate exceeds the level of concern ( MOE = 340).

$ Chemical specific data from a turf transferable residue ( TTR) study were available. A dissipation rate of 8% daily was derived from this data and translated to residential application. The Residential SOPs were utilized to estimate initial residues ( i. e. DAT 0 residues) based on application rate and to estimate contact rates with turf. The data show that 6.1%, 0.85%, and 0.59% ( for CA, IN & MS, respectively) of the applied fenarimol was detected on DAT 0. By comparison, the Agency's SOP uses a transfer efficiency ( percent of application rate) of 5%. Therefore, due to the variability of the study transfer efficiency data, the poor quality of the study itself, and because no transfer coefficient exists for the California roller method that was used in this study, a 5% transfer efficiency 8 rate was used for risk assessment purposes. Additional TTR data would allow further refinement of the exposure estimate. Aggregate Risk ( For a complete discussion, see section 5.0 of the Human Health Risk Assessment)

$ The aggregate risk assessment for fenarimol examines the combined risk from exposure through food, drinking water, and residential exposure where applicable.

$ Because an acute toxicity endpoint was not identified, an acute aggregate risk assessment is not required.

$ Based on agreements with the registrant regarding amendments ( i. e., removal of residential uses) to product labels, the Agency anticipates neither residential handler nor residential postapplication exposure to children. Consequently, these scenarios were not included in an aggregate risks assessment.

$ Since the residential uses are being removed from the labels only the short term dermal postapplication exposures for adult golfers was combined with the average dietary ( food & water) exposures in a short term aggregate risk assessment. The aggregate risk estimate for the postapplication short term dermal exposure scenario of golfing did not exceed the Agency's level of concern. The exposure from food is zero for adults; therefore, the aggregate risk estimates include only dermal and water exposures. The short term DWLOCs are calculated to be 1267 ppb for adult males and 1086 ppb for adult females which are well above the estimated EECs for ground ( 16 ppb) and surface water ( 26 ppb), and indicate that combined short term dietary ( food & water) and dermal exposures do not exceed the Agency's level of concern.

$ The EEC for ground water is less than all DWLOCs; therefore, there is no concern for aggregate chronic exposure to fenarimol and its degradates from food and ground water.

$ Excluding the residential use, the EEC for surface water ( 26 ppb) slightly exceeds the DWLOC for children under 6. However, the estimated EEC for surface water is a very conservative estimate. The surface water EEC is not likely to underestimate exposure to fenarimol and its degradates based on the conservative inputs to the model ( i. e., default PCA, no decay via the major degradation pathway, and the concentrated application scenario modeled is unlikely to occur in a real watershed where drinking water is derived).

Occupational and Ecological Risk $ Because fenarimol is under review for tolerance reassessment only, no occupational or ecological risk assessment was not conducted. 9 Tolerance Reassessment Summary ( For a complete discussion, see Fenarimol, Product and Residue Chemistry Chapter for the Tolerance Reassessment Eligibility Decision, dated 10/ 18/ 2001.)

The Agency has reassessed all 42 tolerances for fenarimol and can make a FQPA safety determination.

Table 2 Tolerance Reassessment Summary For Fenarimol.

Commodity Established Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment [ Correct Commodity Definition]

Tolerance Listed Under 40 CFR § 180.421( a)( 1)

Apple pomace ( wet and dry) 2.0 0.3 The available data indicate that the tolerance for wet apple pomace should be reduced. Dry apple pomace is no longer considered a significant livestock feed item. [ Apple, wet pomace]

Apples 0.1 0.1 [ Apple]

Cattle, fat 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Cattle, meat 0.01 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Cattle, mbyp 0.01 0.05 [ Cattle, meat byproducts, except kidney] Residue data indicate that the tolerance should be reassessed at 0.05 ppm.

Cattle, kidney 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Cattle, liver 0.1 Revoke [ included in meat byproducts]

Eggs 0.01 Revoke There are no poultry feed items associated with presently registered uses.

Goat, fat 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Goat, meat 0.01 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Goat, mbyp 0.01 0.05 [ Goat, meat byproducts, except kidney] Residue data indicate that the tolerance should be reassessed at 0.05 ppm.

Goat, kidney 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Goat, liver 0.1 Revoke [ included in meat byproducts]

Hog, fat 0.1 Revoke There are no hog feed items associated with presently registered uses. Hog, meat 0.01 Revoke Hog, mbyp 0.01 Revoke Hog, kidney 0.1 Revoke Commodity Established Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment [ Correct Commodity Definition]

10 Hog, liver 0.1 Revoke Horse, fat 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Horse, meat 0.01 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Horse, mbyp 0.01 0.05 [ Horse, meat byproducts, except kidney] Residue data indicate that the tolerance should be reassessed at 0.05 ppm.

Horse, liver 0.1 Revoke [ included in meat byproducts]

Horse, kidney 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Milk 0.003 Revoke Category 3 of 40 CFR § 180.6( a)

Pears 0.1 0.1 [ Pear]

Pecans 0.1 0.02 [ Pecan] Residue data have been submitted to reassess the established tolerance for pecans.

Poultry, fat 0.01 Revoke There are no poultry feed items associated with presently registered uses. Poultry, meat 0.01 Revoke Poultry, mbyp 0.01 Revoke Sheep, fat 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Sheep, meat 0.01 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Sheep, mbyp 0.01 0.05 [ Sheep, meat byproducts, except kidney] Residue data indicate that the tolerance should be reassessed at 0.05 ppm.

Sheep, kidney 0.1 0.01 Residue data indicate that the tolerance should be reassessed at 0.01 ppm ( method limit of quantitation [ LOQ]).

Sheep, liver 0.1 Revoke [ included in meat byproducts]

Tolerance Listed Under 40 CFR § 180.421( a)( 2)

Bananas 1 0.5 ( Not more than 0.25 ppm shall be present in the pulp after peel is removed) 0.25 [ Banana] Residue data have been submitted to reassess the established tolerance for bananas.

Cherries 1.0 1.0 [ Cherry]

Grape juice 0.6 Revoke Not required based on reexamination of available grape processing data. Commodity Established Tolerance ( ppm) Reassessed Tolerance ( ppm) Comment [ Correct Commodity Definition]

11 Grape pomace ( wet and dry) 2.0 Revoke No longer considered a significant livestock feed item.

Grapes 0.2 0.1 [ Grape] Residue data have been submitted to reassess the established tolerance for grapes.

Raisin waste 3.0 Revoke No longer considered a significant livestock feed item.

Raisins 0.6 Revoke Not required based on reexamination of available grape processing data.

Tolerance to be Established Under 40 CFR § 180.421( a)( 1)

Filberts not applicable 0.02 Residue chemistry data support the establishment of a 0.02 ppm tolerance for filberts.

1 For tolerance reassessment purposes, the banana tolerance is counted as two tolerances to reflect the baseline count determined at the start of FQPA ( bananas and bananas, pulp).

Codex/ International Harmonization The Codex Alimentarius Commission has established several maximum residue limits ( MRLs) for residues of fenarimol in/ on various raw agricultural and processed commodities. The Codex MRLs are expressed in terms of fenarimol per se. A numerical comparison of the Codex MRLs and the corresponding reassessed U. S. tolerances is presented in the Table below. The Table shows that except for cattle liver, cherries, and pecans, the U. S. tolerances and Codex MRLs are not in harmony with respect to numerical levels.

Table 3 Codex MRLs and applicable U. S. tolerances for fenarimol. Recommendations are based on conclusions following reassessment of U. S. tolerances.

Codex Reassessed U. S. Tolerance, ppm Recommendation And Comments Commodity, As Defined MRL 1 ( mg/ kg)

Apple pomace, dry 5 wet apple pomace = 0.3 Dry apple pomace is no longer considered a significant livestock feed item.

Artichoke globe 0.1

Banana 0.2 0.25 Cattle kidney 0.02 (*) 0.01 (*)

Cattle liver 0.05 Revoke covered by tolerance for meat byproducts Cattle meat 0.02 (*) 0.01 (*)

Cherries 1 1 Dried grapes ( currants, raisins and sultanas) 0.2 Revoke Codex Reassessed U. S. Tolerance, ppm Recommendation And Comments Commodity, As Defined MRL 1 ( mg/ kg)

12 Grapes 0.3 0.1 Hops, dry 5

Melons, except watermelon 0.05

Peach 0.5

Pecan 0.02 (*) 0.02 (*)

Peppers, sweet 0.5

Pome fruits 0.3 apple/ pear = 0.1 Strawberry 1

1 All MRLs are at CXL step. An asterisk (*) signifies that the MRL or US tolerance was established at or about the limit of detection.

Fenarimol Data Gaps The following confirmatory data requirements have been initially identified by the Agency:

Environmental Fate Data:

835.1230 Sediment and Soil Adsorption/ Desorption for parent and degradates 835.2240 Direct Photolysis Rate of Parent and Degradates in Water 835.2410 Photodegradation of Parent and Degradates in Soil 835.4300 Aerobic Aquatic Metabolism for parent and degradates 835.4400 Anaerobic Aquatic Metabolism for parent and degradates 835.6100 Terrestrial Field Dissipation Product and Residue Chemistry Data:

Additional data are required concerning enforcement analytical methods, stability, storage stability, pH, UV/ Visible absorption, density, octanol/ water partition coefficient, and solubility ( OPPTS 830.1800, 6313, 6317, 7000, 7050, 7300, 7550, and 7840) of the T/ TGAI.

Storage stability data for livestock commodities are required to support the storage intervals used in the livestock feeding studies.

Toxicology Data:

870.2500 Primary Dermal Irritation Study 13 870.3465 28 Day Subchronic Inhalation Study 870.6300 Special Developmental Toxicity Study in Rats


[Federal Register Volume 82, Number 76 (Friday, April 21, 2017)]
[Notices]
[Pages 18822-18824]
[FR Doc No: 2017-08104]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2017-0002-N-11]

Proposed Agency Information Collection Activities; Comment
Request

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notice and comment request.

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SUMMARY: Under the Paperwork Reduction Act of 1995 (PRA), this notice
announces FRA is forwarding for renewal the Information Collection
Request (ICR) abstracted below to the Office of Management and Budget
(OMB) for review and comment. The ICR describes the information
collection and its expected burden. On December 21, 2016, FRA published
a notice providing a 60-day period for public comment on the ICR.

DATES: Comments must be submitted on or before May 22, 2017.

FOR FURTHER INFORMATION CONTACT: Mr. Robert Brogan, Information
Collection Clearance Officer, Office of Railroad Safety, Regulatory
Analysis Division, RRS-21, Federal Railroad Administration, 1200 New
Jersey Avenue SE., Mail Stop 25, Washington, DC 20590 (Telephone: (202)
493-6292); or Ms. Kim Toone, Information Collection Clearance Officer,
Office of Administration, Office of Information Technology, RAD-20,
Federal Railroad Administration, 1200 New Jersey Avenue SE., Mail Stop
35, Washington, DC 20590 (Telephone:<PHONE_NUMBER>). (These telephone
numbers are not toll free.)

SUPPLEMENTARY INFORMATION: The PRA, 44 U.S.C. 3501-3520, and its
implementing regulations, 5 CFR part 1320, require Federal agencies to
issue two notices seeking public comment on information collection
activities before OMB may approve paperwork packages. 44 U.S.C. 3506,
3507; 5 CFR 1320.5, 1320.8(d)(1), and 1320.12. On December 21, 2016,
FRA published a 60-day notice in the Federal Register soliciting
comment on the ICR for which it is now seeking OMB approval. See 81 FR
93725. On February 21, 2017, FRA received one comment in response to
the 60-day notice from Mr. Jeffrey S. Hollister, President and CEO of
American Railcar Industries (ARI), Inc.
    Many of ARI's comments focus on the substantive merits of the
Railworthiness Directive and Revised Railworthiness Directive
(collectively RWD or Directive unless stated otherwise) this ICR
pertains to and FRA's authority to issue the RWD. Because these
comments are outside the scope of the PRA burden analyzed in this
notice, and because the RWD is currently the subject of a legal action
brought by ARI, FRA cannot respond to those comments in this notice.
Consistent with the PRA, however, FRA is addressing each of ARI's
comments on the accuracy of FRA's estimates of the burdens of the
information collection activities associated with the RWD.
    In its comments, ARI expresses the view ``FRA dramatically
underestimates the burdens created by the information collection
activities required by the Directive.'' Specifically, ARI alleges FRA's
burden estimates are too low in the following eight instances:
    (1) To identify the 14,800 tank cars subject to the Directive, FRA
estimated the total annual burden as 80 hours, but ARI estimates 900
hours because ``the time calculated to respond to 100 lessees at 4
hours each is 400 hours, plus FRA failed to account for 500 hours ARI
already has invested in supporting customer requests for information on
the application of the Directive to their cars'';
    (2) To visually inspect the 14,800 tank cars prior to each loaded
trip, FRA estimated the total annual burden as 7,400 hours, but ARI
estimates 98,667 hours. ARI estimates an average of 20 railcar loadings
and 20 minutes for each inspection and the associated documentation
requirements;
    (3) To inspect and test the sump and bottom outlet valve (BOV) skid
groove attachment welds and maintain record results for over 2,200 tank
cars, FRA estimates the total annual burden hours as 6,600 hours, but
ARI estimates 53,200 hours based on the assumption that each inspection
and test will take 26.5 hours;
    (4) FRA estimated no total annual burden hours for removal of tank
linings to perform visual inspections on 0 percent of the cars to be
inspected. ARI estimates 2 hours per car or an additional 1,320 total
annual burden hours;
    (5) To train and test tank car mechanics who are not qualified on
non-destructive testing (NDT) procedures and record qualification, FRA
estimated the total annual burden as 132 hours, but ARI estimates 640
hours. ARI asserts FRA did not take into account the need to train 100
inspectors, develop the NDT procedures, or prepare specimens and
training procedures;
    (6) For tank car notification to all parties of the terms of the
Directive and inspection/testing schedule, FRA estimated the total
annual burden as 100 hours, but ARI estimates 8,800 hours. ARI notes
that ``FRA estimates only 100 notices at one hour each while ARI
assumes this task requires the development of over 2,200 plans at 4
hours per car to get each car to a shop, develop a freight plan, shop
schedule, and out-of-service time'';
    (7) For reports of inspection, test, and repair to FRA, ARI states
FRA estimated the total annual burden hours as 3,300 hours, but ARI
estimates 6,600 hours. (FRA notes that, in its approved Emergency
Clearance submission to OMB, it previously estimated this burden at
33,600 hours, not the erroneous 3,300 hours in its 60-day December 21,
2016, Federal Register notice which ARI cited in its comments). ARI
explains it estimates 3 hours per car/report ``in order to include the
time ARI spends to review the reports, correct factual errors, store
results, update the database and provide summaries to the FRA''; and
    (8) For tank car facility requests to tank car owners for written
permission and approval of qualification and maintenance programs, FRA
estimated the total annual burden as 7 hours, but ARI estimates 660
hours for 330 cars (15%) which will require owner's approval and
instructions prior to repair which will require 2 hours per car.
    After careful consideration of ARI's comments and estimates, FRA
reviewed its own estimates and either validated its initial estimates
or adjusted its estimates in light of ARI's comments. As a result, FRA
now estimates a total annual burden for this ICR in excess of the
68,953 hours originally approved by OMB on October 18, 2016, in FRA's

Emergency Clearance submission. FRA's modified burden estimates are as
follows:
    (1) To identify the railroad tank cars subject to the RWD, FRA
stands by its original estimate of 20 identifications/reports--one
report for each of the estimated 20 tank car owners/100 lessees (5
lessees per tank car owner are included/incorporated in each
identification/report)--and 80 hours (4 hours per identification/
report). FRA believes ARI's estimate of 900 hours is excessive because
tank cars built to the ARI or ACF Industries, LLC (ACF) 300 stub sill
design and subject to the Directive are easily identifiable based upon
their certificates of construction which all tank car owners are
required to retain;
    (2) To visually inspect the tank cars prior to each loaded move,
FRA has revised its previous estimate of 7,400 total annual burden
hours to 14,529 total burden hours. FRA believes the number of annual
load moves is 6 and each visual inspection/record takes approximately
10 minutes to complete, while ARI estimates there are 20 annual load
moves per year and each visual inspection/record takes 20 minutes to
complete. To arrive at its total burden of 98,667 hours, ARI more than
triples the number of annual load moves (20 moves instead of 6 moves)
and doubles the time to complete each visual inspection/record (20
minutes instead of 10 minutes). FRA subject matter experts state the
number of annual load moves is well under 10 and completing the
required visual inspection/record is not a time consuming process and
should take significantly less than 20 minutes;
    (3) To inspect and test the sump and BOV skid groove attachment
welds and maintain record results, FRA has revised its estimate to
reflect the 2,175 cars subject to this requirement (15 percent of the
estimated fleet of 14,500 cars subject to the Directive) \1\ and has
increased its estimate of the average time it takes to complete this
requirement from 2 hours to 19 hours (i.e., 4 hours for cleaning,
inbound inspection, and estimating (write-up), plus 3 hours for
inspection, testing, records preparation for visual and ultrasonic
testing, plus 12 hours for car repairs). Thus, FRA has raised its
previous estimate of 6,600 total annual burden hours to 41,325 total
annual burden hours. FRA's adjusted estimate of 41,325 hours
approximates the ARI asserted total burden of 53,200 hours. Again, the
experience of FRA subject matter experts supports this revised number
as closer to the true burden than either FRA's initial estimate or
ARI's estimate in its comments;
---------------------------------------------------------------------------

    \1\ FRA recognizes the total fleet of cars subject to this RWD
is approximately 14,800, but based on written and verbal reports
provided to FRA to date, FRA understands that 300 cars have already
been inspected under terms meeting the RWD.
---------------------------------------------------------------------------

    (4) For removal of the tank lining as part of the visual
inspection/testing/repair requirement, FRA believes it will be
necessary to remove the tank lining in 435 tank cars to conduct the
inspections and tests this RWD requires (20% of the 2,175 cars to be
inspected under this RWD (again, 2,175 is 15% of the estimated total
fleet subject to the RWD)). In its comments, ARI estimates it will be
necessary to remove the tank lining in 660 cars (approximately 30
percent of the cars required to be inspected under this RWD). FRA also
estimates this process will take an average of 2 hours per car to
complete. FRA's revised burden total amounts to 870 hours while ARI's
total burden is 1,320 hours. FRA believes this estimate is closer to
the actual burden, as supported by the experience of its subject matter
experts;
    (5) To train and test tank car mechanics who are not qualified on
NDT procedures and record qualification, FRA has revised its original
estimate of the total number of individuals who will need such training
to 90. FRA now estimates it will take approximately 2 hours to train
each person (for a total annual burden hours of 180 hours). ARI
estimates 100 individuals will be trained and it will take
approximately 6.4 hours to complete each person's training (for a total
annual burden of 640 hours). FRA and ARI are in the same vicinity
concerning the number of individuals to be trained, but disagree on the
average time to complete the necessary training. FRA has doubled its
original average time estimate and believes two hours is more than
adequate to complete this requirement;
    (6) For tank car notification to all parties of the terms of the
Directive and inspection/testing schedule, FRA is maintaining its
estimate of 100 notifications to the affected parties (i.e., tank car
lessees), but is doubling the average time to complete each
notification to 2 hours (for a total burden of 200 hours). ARI
calculates its estimated burden of 8,800 hours to include 2,200 cars
and 4 hours to complete each required notification. However, ARI
misinterprets the requirement and applies the notifications to cars
rather than all parties under contract to tank car owners.
Consequently, it vastly overestimates the number of notifications.
ARI's average time estimate of 4 hours per notification is double FRA's
revised estimate and because it is based on cars, not parties under
contract to the tank car owners, it is not based on facts and is
unrealistic;
    (7) For reports of inspection, test, and repair information to FRA,
FRA already accounted for this burden in its earlier 19-hour estimate
in (3) above for inspection, testing, repair, and corresponding records
that totaled 41,325 hours. ARI estimated this burden at 53,200 hours as
explained in (3) above, but then includes an additional burden here of
6,600 hours. Thus, ARI has mistakenly double-counted this burden;
    (8) For tank car facility requests to tank car owners for written
permission and approval of qualification and maintenance programs, FRA
stands by its original total annual burden estimate of 7 hours (20
written requests plus 20 written permissions at 10 minutes each). FRA
believes ARI's estimate of 660 hours misinterprets the requirement. ARI
includes a written permission by the tank car owner for 330 cars (15%
of 2,220 cars) rather than for the qualification and maintenance
program operated by the tank car facility. FRA does not believe it will
take triple the time (60 minutes as opposed to 20 minutes) to complete
each written request and triple the time to complete each written
permission (again 60 minutes as opposed to 20 minutes). Thus, FRA is
maintaining its original estimate for this requirement;
    (9) For reports by tank car facilities to tank car owners of all
work performed and all observed damage, deterioration, failed
components, or noncompliant parts under 49 CFR 180.513, FRA estimates
there will be 2,175 repair reports/records and it will take
approximately 12 hours to complete each weld defect repair and
associated report/record for a total annual burden of 26,100 hours. ARI
did not state its estimate for this requirement in its comment.
Nevertheless, based on its stated total burden of 176,092 hours, it
appears ARI estimated a total of 2,200 reports would be completed with
an average time of 2.411 hours to complete each repair report/record
(for a total of 5,305 hours). FRA believes ARI underestimated the time
necessary to complete repairs for weld defects and the corresponding
report/record and, thus, the true burden. FRA is once again relying on
the experience and knowledge of its subject matter experts; and
    (10) Finally, regarding the new exemption provision in the Revised
Directive, FRA estimates 10 tank car owners will request exemptions
from all

or part of the requirements of the RWD for a total of 149 hours (14.9
hours per petition). Neither FRA nor ARI accounted for this potential
burden previously.
    Overall, FRA's modified estimates amount to 83,440 hours. For the
reasons outlined above, FRA believes this revised total is more
accurate and more reasonable than its original estimates \2\ and ARI's
estimate of 176,092 hours.
---------------------------------------------------------------------------

    \2\ FRA notes its December 21, 2016, 60-day Federal Register
notice contained an error in math. The total burden in that notice
should have been 30,240 hours higher (for a total burden of 53,164
hours). See 81 FR 93725.
---------------------------------------------------------------------------

    Before OMB decides whether to approve these proposed collections of
information, it must provide 30 days for public comment. 44 U.S.C.
3507(b); 5 CFR 1320.12(d). Federal law requires OMB to approve or
disapprove paperwork packages between 30 and 60 days after the 30-day
notice is published. 44 U.S.C. 3507(b)-(c); 5 CFR 1320.12(d); see also
60 FR 44978, 44983, Aug. 29, 1995. OMB believes the 30-day notice
informs the regulated community to file relevant comments and affords
the agency adequate time to digest public comments before it renders a
decision. 60 FR 44983, Aug. 29, 1995. Therefore, respondents should
submit their respective comments to OMB within 30 days of this notice's
publication. 5 CFR 1320.12(c); see also 60 FR 44983, Aug. 29, 1995.
    The summary below describes the ICR and its expected burden. FRA is
submitting this renewal request for clearance by OMB as the PRA
requires.
    Title: Railworthiness Directive (RWD) RWD 2016-01 [REVISED]
(previously approved by OMB under the title Railworthiness Directive
for Certain Tank Cars Equipped with Bottom Outlet Valve Assembly and
Constructed by American Railcar Industries and ACF Industries).
    OMB Control Number: 2130-0616.
    Abstract: An FRA investigation identified a certain design of
specification DOT-111 tank cars that ARI and ACF manufactured using
welding practices not in conformance with Federal regulations and
Association of American Railroads' welding specifications. The cars are
built to the ARI and ACF 300 stub sill design and equipped with a two-
piece cast sump and BOV skid. As a result of the non-conforming welding
practices, these cars may have substantial weld defects at the sump and
BOV skid groove attachment welds, potentially affecting each tank's
ability to retain its contents during transportation. On September 30,
2016, FRA issued the initial RWD. On November 18, 2016, FRA issued a
Revised Directive. The Revised Directive requires owners to: (1)
Identify tank cars in their fleet covered by the Directive; and (2)
ensure appropriate inspection and testing of each tank car's sump and
BOV skid groove attachment welds to ensure no flaw exists which could
result in the loss of tank integrity. This ICR applies to the Revised
Directive.
    Type of Request: Regular clearance of an information collection
previously approved under emergency processing procedures.
    Affected Public: Businesses (tank car owners, shippers, and tank
car facilities).
    Form(s): N/A.
    Total Estimated Annual Responses: 92,250.
    Total Estimated Annual Burden: 83,440 hours.
    Addressee: Send comments regarding these information collections to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th Street NW., Washington, DC 20503, Attention: FRA
Desk Officer. Comments may also be sent via email to OMB at the
following address<EMAIL_ADDRESS>    Comments are invited on the following: Whether the proposed
collections of information are necessary for DOT to properly perform
its functions, including whether the information will have practical
utility; the accuracy of DOT's estimates of the burden of the proposed
information collections; ways to enhance the quality, utility, and
clarity of the information to be collected; and ways to minimize the
burden of the collections of information on respondents, including the
use of automated collection techniques or other forms of information
technology.

    Authority:  44 U.S.C. 3501-3520.

Sarah L. Inderbitzin,
Acting Chief Counsel.
[FR Doc. 2017-08104 Filed 4-20-17; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register: November 3, 2008 (Volume 73, Number 213)]
[Notices]
[Page 65384-65385]
[DOCID:fr03no08-49]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0572]

Agency Emergency Processing Under Office of Management and Budget
Review; Implementation of the Animal Generic Drug User Fee Act of 2008;
User Fee Cover Sheet Form FDA 3728

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for emergency processing under the
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of
information concerns the burden hours required for the Animal Generic
Drug User Fee Cover Sheet, Form FDA 3728 and the timeframe requirement
under the Animal Generic Drug User Fee Act of 2008 (AGDUFA) (21 U.S.C.
379j-21) for implementing the new user fee cover sheet Form FDA 3728.

DATES: Fax written comments on the collection of information by
November 10, 2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
``Implementation of the Animal Generic Drug User Fee Act of 2008 (21
U.S.C. 379j-21(a)); User Fee Cover Sheet Form 3728; Emergency
Request.'' Also include the FDA docket number found in brackets in the
heading of this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: FDA is requesting emergency processing of
this proposed collection of information under section 3507(j) of the
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The Federal Food, Drug, and
Cosmetic Act (the act), as amended by AGDUFA authorizes FDA to collect
user fees: (1) For certain abbreviated applications for a generic new
animal drug, (2) on certain generic new animal drug products, and (3)
on certain sponsors of such abbreviated applications for generic new
animal drugs and/or investigational submissions for generic new animal
drugs.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Implementation of the Animal Generic Drug User Fee Act of 2008; User
Fee Cover Sheet Form FDA 3728 (21 U.S.C. 379j-21); Emergency Request

    Section 741 of the act (21 U.S.C. 379j-21), establishes three
different kinds of user fees: (1) Fees for certain types of abbreviated
applications for generic new animal drugs, (2) annual fees for certain
generic new animal drug products, and (3) annual fees for certain
sponsors of abbreviated applications for generic new animal drugs and/
or investigational submissions for generic new animal drugs. Because
the submission of user fees concurrently with applications is required,
the review of an application cannot begin until the fee is submitted.
Form FDA 3728, the Animal Generic Drug User Fee Cover Sheet, is
designed to provide the minimum necessary information in order to: (1)
Determine whether a fee is required for review of an application, (2)
determine the amount of fee required, and (3) account for and track
user fees.
    FDA estimates the burden of this collection of information as
follows:

                                  Table 1--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
 21 U.S.C. 379j-      Respondents        per Response        Responses           Response         Total Hours
-------21.------------------------------------------------------------------------------------------------------
Form FDA 3728                     20                  2                 40                .08                3.2
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Respondents to this collection of information are generic new
animal drug applicants. Based on FDA's data base system, there are an
estimated 20 sponsors of new animal drugs potentially subject to
AGDUFA. The

annual reporting burden estimates in table 1 of this document are based
on FDA's previous experience.

    Dated: October 29, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-26162 Filed 10-31-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 211 (Wednesday, October 31, 2018)]
[Notices]
[Pages 54749-54750]
[FR Doc No: 2018-23750]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2018-0118; FRL-9985-42-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Servicing of Motor Vehicle Air Conditioners
(Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Servicing of Motor Vehicle Air
Conditioners (EPA ICR No. 1617.09, OMB Control No. 2060-0247) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through December 31,
2018. Public comments were previously requested via the Federal
Register on June 6, 2018 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Comments must be submitted on or before November 30, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2018-0118, to (1) EPA online using www.regulations.gov (our preferred
method), by email to [email protected], or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
[email protected]. Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Christina Thompson, Stratospheric
Protection Division, Office of Atmospheric Programs (Mail Code 6205T),
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Section 609 of the Clean Air Act Amendments of 1990 (Act)
provides general guidelines for the servicing of motor vehicle air
conditioners (MVACs). It states that ``no person repairing or servicing
motor vehicles for consideration may perform any service on a motor
vehicle air conditioner involving the refrigerant for such air
conditioner without properly using approved refrigerant recycling
equipment and no such person may perform such service unless such
person has been properly trained and certified.'' In 1992, EPA
developed regulations under section 609 that were published in 57 FR
31242, and codified

at 40 CFR Subpart B (Section 82.30 et seq.). The information required
to be collected under the section 609 regulations is: Approved
refrigerant handling equipment; approved independent standards testing
organizations; technician training and certification; and
certification, reporting and recordkeeping.
    Form Numbers: None.
    Respondents/affected entities: The following is a list of NAICS
codes for organizations potentially affected by the information
requirements covered under this ICR. It is meant to include any
establishment that may service or maintain motor vehicle air
conditioners.
4411 Automobile Dealers
4413 Automotive Parts, Accessories, and Tire Stores
44711 Gasoline Stations with Convenience Stores
8111 Automotive Repair and Maintenance
811198 All Other Automotive Repair and Maintenance
Other affected groups include independent standards testing
organizations and organizations with technician certification programs.
    Respondent's obligation to respond: Mandatory (40 CFR 82.36, 82.38,
82.40, 82.42).
    Estimated number of respondents: 45,902 (per year).
    Frequency of response: On occasion, biennially, only once.
    Total estimated burden: 4,130 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $218,009 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in estimates: There is a decrease of 33 hours in the total
estimated respondent burden compared with the ICR currently approved by
OMB. This decrease is due in part to a decrease in the number of new
technician certifications and the time allotted for maintenance of the
technician certification records. The time associated with the
maintenance of these records has decreased, recognizing the move
towards electronic recordkeeping which may be more efficient.
Additionally, a decrease in the market for small containers of CFC-12
refrigerant has also decreased the burden.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2018-23750 Filed 10-30-18; 8:45 am]
 BILLING CODE 6560-50-P45