from the 3 runs.

*	*	*	*	*

9. Section 63.1513 is amended by:

a. By revising paragraph (b)

b. By revising paragraph (b)(1);

c. By revising paragraph (e)(1);

d. By revising paragraph (e)(2); and

e. By revising paragraph (e)(3)to read as follows:

§63.1513 Performance test/compliance demonstration requirements and
procedures.

*	*	*	*	*

(b) PM, HCl/HF and D/F emission limits. (1) Use Equation 7 of this
section to determine compliance with an emission limit for PM or HCl/HF:

 Where:

E = Emission rate of PM or HCl/HF, kg/Mg (lb/ton) of feed;

C = Concentration of PM or HCl, g/dscm (gr/dscf);

Q = Volumetric flow rate of exhaust gases, dscm/hr (dscf/hr);

K1= Conversion factor, 1 kg/1,000 g (1 lb/7,000 gr); and

P = Production rate, Mg/hr (ton/hr).*	*	*	*	*

(e) *	*	*

(1) Use Equation 9 to compute the mass-weighted PM emissions for a
secondary aluminum processing unit. Compliance is achieved if the
mass-weighted emissions for the secondary aluminum processing unit
(EcPM) is less than or equal to the emission limit for the secondary
aluminum processing unit (LcPM) calculated using Equation 1 in
§63.1505(k).

Where,

EcPM= The mass-weighted PM emissions for the secondary aluminum
processing unit;

EtiPM= Measured PM emissions for individual emission unit, or group of
co-controlled emission units, i;

Tti= The average feed rate for individual emission unit i during the
operating cycle or performance test period, or the sum of the average
feed rates for all emission units in the group of co-controlled emission
unit i; and

n= The number of individual emission units, and groups of co-controlled
emission units in the secondary aluminum processing unit.

(2) Use Equation 10 to compute the aluminum mass-weighted HCl/HF
emissions for the secondary aluminum processing unit. Compliance is
achieved if the mass-weighted emissions for the secondary aluminum
processing unit (EcHCl/HF) is less than or equal to the emission limit
for the secondary aluminum processing unit (LcHCl/HF) calculated using
Equation 2 in §63.1505(k).

Where,

EcHCl/HF= The mass-weighted HCl and HF emissions for the secondary
aluminum processing unit; and

EtiHCl/HF= Measured HCl/HF emissions for individual emission unit, or
group of co-controlled emission units i.

(3) Use Equation 11 to compute the aluminum mass-weighted D/F emissions
for the secondary aluminum processing unit. Compliance is achieved if
the mass-weighted emissions for the secondary aluminum processing unit
is less than or equal to the emission limit for the secondary aluminum
processing unit (LcD/F) calculated using Equation 3 in §63.1505(k).

Where,

EcD/F= The mass-weighted D/F emissions for the secondary aluminum
processing unit; and

EtiD/F= Measured D/F emissions for individual emission unit, or group of
co-controlled emission units i.

*	*	*	*	*

10. Section 63.1514 is revised to read as follows:

§63.1514 Change of Furnace Classification.

(a) Changing from a group 1 controlled furnace processing other than
clean charge to group 1 uncontrolled furnace processing other than clean
charge.

An owner or operator wishing to change operating modes must conduct
performance tests to demonstrate to the delegated permitting authority
that compliance can be achieved under both modes. Operating parameters
relevant to each mode of operation must be established during the
performance test.

(1) Operators of major sources must conduct performance tests for PM,
HCl/HF and D/F, according to the procedures in §63.1512(d) with the
capture system and control device operating normally.

(i) The performance tests must be conducted with the scrap containing
the highest level of contamination expected to be processed, at the
highest throughput expected and using the highest rate of reactive flux
injection expected to be processed in controlled mode.

(ii)Parameters for capture, flux rate, and lime injection must be
established during these tests.

(iii) The emission factors for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(2) Operators of major sources must conduct additional performance tests
for PM, HCl/HF and D/F, according to the procedures in §63.1512(e)
without operating a control device.

(i) Testing under this paragraph may be conducted at any time after the
furnace has completed 1 or more charge to tap cycles, or 24 operating
hours with scrap of the highest level of contamination expected to be
processed in uncontrolled mode.

	(ii) Testing under this paragraph must be conducted with furnace
emissions captured in accordance with the provisions of §63.1512(e)(4)
and directed to the stack or vent tested.

(iii) Parameters for capture and flux rate must be established during
these tests.

(iv) The emission factors for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(3) Operators of area sources must conduct performance tests for D/F,
according to the procedures in §63.1512(d) with the capture system and
control device operating normally.

(i) The performance tests must be conducted with the scrap containing
the highest level of contamination expected to be processed, at the
highest throughput expected to be processes and using the highest rate
of reactive flux injection expected to be processed in controlled mode.

(ii) Parameters for capture, flux rate, and lime injection must be
established during these tests.

(iii) The emission factors for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(4) Operators of area sources must conduct performance tests for D/F,
according to the procedures in §63.1512(e) without operating a control
device.

(i) Testing under this paragraph may be conducted at any time after the
furnace has completed 1 or more charge to tap cycles, or 24 operating
hours with scrap of the highest level of contamination expected to be
processed in uncontrolled mode.

(ii) Testing under this paragraph must be conducted with furnace
emissions captured in accordance with the provisions of §63.1506(c) and
directed to the stack or vent tested.

(iii) Parameters for capture and flux rate must be established during
these tests.  In addition the number of cycles of furnace operation with
scrap of the highest level of contamination expected to be processed in
uncontrolled mode that elapsed prior to the performance test(s)
conducted in uncontrolled mode is established as a parameter.

(iv) The D/F emission factor for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(5) To switch modes of operation from uncontrolled to controlled, the
owner or operator must, before charging scrap to the furnace that
exceeds the contaminant level established for uncontrolled mode,

(i) Change the label on the furnace to reflect controlled operation,

(ii) Direct the furnace emissions to the control device, and

(iii) Begin lime addition to the control device at the rate established
for controlled mode.

(6) To switch modes of operation from controlled to uncontrolled, the
owner or operator must, before turning off or bypassing the control
device,

(i) Change the label on the furnace to reflect controlled operation,

(ii) Charge scrap with a level of contamination no greater than that
used in the performance test for uncontrolled furnaces for the number of
charge to tap cycles that elapsed with scrap of a contamination level no
higher than that used in the uncontrolled mode performance test(s), and

(iii) Decrease the flux addition rate to no higher than the flux
addition rate used in the uncontrolled mode performance test.

(7) In addition to the recordkeeping requirements of §63.1517, the
owner or operator must maintain records of the nature of each mode
switch (controlled to uncontrolled, or uncontrolled to controlled), the
time the switch is initiated, and the time the exhaust gas is diverted
from control device to bypass or bypass to control device.

(b) Changing from a group 1 controlled furnace processing other than
clean charge and to group 1 uncontrolled furnace processing clean
charge. An owner or operator wishing to operate under controlled mode
with other than clean charge and uncontrolled mode with clean charge
must conduct performance tests to demonstrate to the delegated
permitting authority that compliance can be achieved in both modes.
Operating parameters relevant to each mode of operation must be
established during the performance test.

(1) Operators of major sources must conduct performance tests for PM,
HCl/HF and D/F, according to the procedures in §63.1512 with the
capture system and control device operating normally.

(i) The performance tests must be conducted with the scrap containing
the highest level of contamination expected to be processed, at the
highest throughput expected to be processed and using the highest rate
of reactive flux injection expected in controlled mode.

(ii) Parameters for capture, flux rate, and lime injection must be
established during these tests.

(iii) The emission factors for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(2) Operators of major sources must conduct performance tests for PM,
HCl and D/F, according to the procedures in §63.1512 without operating
a control device.

(i) Testing under this paragraph  may be conducted at any time after the
furnace has completed 1 or more charge to tap cycles with clean charge.

(ii) Testing under this paragraph must be conducted with furnace
emissions captured in accordance with the provisions of §63.1506(c) and
directed to the stack or vent tested.

(iii) Parameters for capture and flux rate must be established during
these tests.

(iv) Emissions of D/F during this test must not exceed 1.5 µg TEQ/Mg of
feed/charge processed, or this mode of operation is not allowed.

(v) The emission factors for PM and HCl/HF for this mode of operation,
for use in the demonstration of compliance with the emission limits for
SAPUs specified in §63.1505(k) must be determined.

(3) Operators of area sources must conduct additional performance tests
for D/F, according to the procedures in §63.1512 with the capture
system and control device operating normally.

(i) The performance tests must be conducted with the scrap containing
the highest level of contamination expected to be processed, at the
highest throughput expected to be processed and using the highest rate
of reactive flux injection expected in controlled mode.

(ii) Parameters for capture, flux rate, and lime injection must be
established during these tests.

(iii) The D/F emission factor for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(4) Operators of area sources must conduct additional performance tests
for D/F, according to the procedures in §63.1512(e) without operating a
control device.

(i) Testing may be conducted at any time after the furnace has completed
1 or more charge to tap cycles with scrap of the highest level of
contamination at the expected to be processed in uncontrolled mode at
the highest throughput expected to be processed in uncontrolled mode.

(ii) Testing under this paragraph must be conducted with furnace
emissions captured in accordance with the provisions of §63.1506(c) and
directed to the stack or vent tested.

(iii) Parameters for flux rate must be established during these tests.
In addition the number of cycles of furnace operation with scrap of the
highest level of contamination expected to be processed in uncontrolled
mode that elapsed prior to the performance test(s) conducted in
uncontrolled mode is established as a parameter.

(iv) The D/F emission factor for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(5) To switch modes of operation from uncontrolled to controlled, the
owner or operator must, before charging scrap to the furnace that
exceeds the contaminant level established for uncontrolled mode,

(i) Change the label on the furnace to reflect controlled operation,

(ii)Direct the furnace emissions to the control device, and

(iii) Begin lime addition to the control device at the rate established
for controlled mode.

(6) To switch modes of operation from controlled to uncontrolled, the
owner or operator must, before turning off or bypassing the control
device,

(i)  Change the label on the furnace to reflect controlled operation,

(ii) Charge clean charge for the number of charge to tap cycles that
elapsed before the uncontrolled mode performance test was conducted, and

(iii) Decrease the flux addition rate to no higher than the flux
addition rate used in the uncontrolled mode performance test.

(7)  In addition to the recordkeeping requirements of §63.1517, the
owner or operator must maintain records of the nature of each mode
switch (controlled to uncontrolled, or uncontrolled to controlled), the
time the switch is initiated, and the time the exhaust gas is diverted
from control device to bypass or bypass to control device.

(c) Changing from a group 1 controlled or uncontrolled furnace to a
group 2 furnace. An owner or operator wishing to change operating modes
must conduct additional performance tests to demonstrate to the
delegated permitting authority that compliance can be achieved under
group 1 mode and establish the number of cycles of operation with clean
charge and no reactive flux addition necessary to elapse before
switching to group 2 mode.  Operating parameters relevant to group 1
operation must be established during the performance test.

(1) Operators of major sources must conduct additional performance tests
for PM, HCl/HF and D/F, according to the procedures in §63.1512.
Controlled group 1 furnaces must conduct performance tests with the
capture system and control device operating normally.

(i) The performance tests must be conducted with the scrap containing
the highest level of contamination expected to be processed, at the
highest throughput expected to be processed and using the highest rate
of reactive flux injection expected to be processed in controlled mode.

(ii) Parameters for throughput, capture, flux rate, and lime injection
must be established during these tests.

(iii) The emission factors for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(2) While in compliance with the operating standards of §63.1506(o) for
group 2 furnaces, operators of major sources must conduct additional
performance tests for PM, HCl/HF and D/F, according to the procedures in
§63.1512(e) without operating a control device.

(i) Testing under this paragraph may be conducted at any time after the
furnace has completed 1 or more charge-to-tap cycles, or 24 operating
hours with clean charge, and without reactive flux addition.

(ii) Testing under this paragraph must be conducted with furnace
emissions captured in accordance with the provisions of §63.1506(c) and
directed to the stack or vent tested.

(iii) Owners or operators must demonstrate that emissions are no greater
than:

(A) 1.5 µg D/F (TEQ) per ton of feed/charge,

(B) 0.04 lb HCl/HF per ton of feed charge, and

(C) 0.04 lb PM per ton of feed/charge.

(iv) The number of charge-to-tap cycles, or operating hours elapsed
before the group 2 furnace performance tests were conducted is
established as an operating parameter to be met before switching to
group 2 mode.

(3) Operators of area sources must conduct additional performance test
for D/F, according to the procedures in §63.1512. Controlled group 1
furnaces must conduct performance tests with the capture system and
control device operating normally.

(i) The performance test must be conducted with the scrap containing the
highest level of contamination expected to be processed, at the highest
throughput expected to be processed and using the highest rate of
reactive flux injection expected to be processed in group 1 mode.

(ii) Parameters for throughput, flux rate, and lime injection must be
established during these tests.

(iii) If the furnace is equipped with a control device parameter(s) for
capture must be established.

(iv) The D/F emission factor for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(4) While in compliance with the operating standards of §63.1506(o) for
group 2 furnaces, operators of area sources must conduct an additional
performance test for D/F, according to the procedures in §63.1512(e),
without operating a control device.

(i) Testing under this paragraph may be conducted at any time after the
furnace has completed 1 or more charge-to-tap cycles, or 24 operating
hours with clean charge, and without reactive flux addition.

(ii) Testing under this paragraph must be conducted with furnace
emissions captured in accordance with the provisions of §63.1506(c) and
directed to the stack or vent tested.

(iii) Owners or operators must demonstrate that emissions are no greater
than 1.5 µg D/F (TEQ) per ton of feed/charge.

(iv) The number of charge-to-tap cycles, or operating hours elapsed
before the group 2 furnace performance tests were conducted is
established as an operating parameter to be met before switching to
group 2 mode.

(d) Changing from a group 1 controlled or uncontrolled furnace to group
2 furnace, for tilting reverberatory furnaces capable of completely
removing furnace contents between batches. An owner or operator of a
tilting reverberatory furnace capable of completely removing furnace
contents between batches, wishing to change operating modes, must
conduct additional performance tests to demonstrate that compliance can
be achieved under group 1 mode. Operating parameters relevant to group 1
operation must be established during the performance test.

(1) Operators of major sources must conduct additional performance tests
for PM, HCl/HF and D/F, according to the procedures in §63.1512.
Controlled group 1 furnaces must conduct performance tests with the
capture system and control device operating normally. The performance
tests must be conducted with the scrap containing the highest level of
contamination expected to be processed, at the highest throughput
expected to be processed and using the highest rate of reactive flux
injection expected to be processed in controlled mode.

(i) Parameters for throughput, capture, flux rate, and lime injection
must be established during these tests.

(ii) The emission factors for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(2) Operators of area sources must conduct an additional performance
test for D/F, according to the procedures in §63.1512. Operators of
controlled group 1 furnaces must conduct performance tests with the
capture system and control device operating normally.

(i) The performance test must be conducted with the scrap containing the
highest level of contamination expected to be processed, at the highest
throughput expected to be processed and using the highest rate of
reactive flux injection expected to be processed in group 1 mode.

(ii) Parameters for throughput, flux rate, and lime injection must be
established during these tests.

(iii) If the furnace is equipped with a control device parameter(s) for
capture must be established.

(iv) The D/F emission factor for this mode of operation, for use in the
demonstration of compliance with the emission limits for SAPUs specified
in §63.1505(k) must be determined.

(3) To switch modes between group 1 and group 2, the operator must

(i) Completely remove all aluminum from the furnace;

(ii) Change the furnace label;

(iii) Use only clean charge; and

(iv) Use no reactive flux;

(4)To switch modes between group 2 and group 1, the owner or operator
must, before charging other than clean charge or reactive flux to the
furnace;

(i) Change the label on the furnace to reflect group 1 operation,

(ii) Direct the furnace emissions to the control device, if any, and,

(iii) Begin lime addition to the control device, if any.

(5) In addition to the recordkeeping requirements of §63.1517, the
owner or operator must maintain records of the nature of each mode
switch (group 1 to group 2, or group 2 to group 1), the time the switch
is initiated, and, if the furnace is equipped with a control device, the
time the exhaust gas is diverted from control device to bypass or bypass
to control device.

(e) Frequency of switching furnace status. Switching furnace status as
provided in paragraphs (a) through (c) of this section may not be done
more frequently than once every 6 months unless necessary to perform
maintenance on the furnace.

*	*	*	*	*

11. Section 63.1515 is amended by removing paragraph (b)(10).

12. Section 63.1516 is amended by:

a. By removing and reserving paragraph (a);

b. By revising paragraph (b)(2)(iii);

c. By adding paragraph (b)(3);

d. By revising paragraph (c); and

e. By adding paragraph(d)to read as follows:

§63.1516 Reports.

*	*	*	*	*

(a) [Reserved]

(b) *	*	*

(2) *	*	*

(iii) For each sidewell group 1 furnace with add-on air pollution
control devices: “Each furnace was operated such that the level of
molten metal remained above the top of the passage between the sidewell
and hearth during reactive fluxing, and reactive flux, except for cover
flux, was added only to the sidewell or to a furnace hearth equipped
with an add-on air pollution control device for PM, HCl/HF, and D/F
emissions during this reporting period.”

*	*	*	*	*

 (3)(i) Within 60 days after the date of completing each performance
test(defined in §63.2) as required by this subpart you must transmit
the results of the performance tests required by this subpart to EPA’s
WebFIRE database by using the Compliance and Emissions Data Reporting
Interface (CEDRI) that is accessed through EPA’s Central Data Exchange
(CDX) (www.epa.gov/cdx). Performance test data must be submitted in the
file format generated through use of EPA’s Electronic Reporting Tool
(ERT) (see http://www.epa.gov/ttn/chief/ert/index.html). Only data
collected using test methods on the ERT website are subject to this
requirement for submitting reports electronically to WebFIRE. Owners or
operators who claim that some of the information being submitted for
performance tests is confidential business information (CBI) must submit
a complete ERT file including information claimed to be CBI on a compact
disk or other commonly used electronic storage media (including, but not
limited to, flash drives) to EPA. The electronic media must be clearly
marked as CBI and mailed to U.S. EPA/OAPQS/CORE CBI Office, Attention:
WebFIRE Administrator, MD C404-02, 4930 Old Page Rd., Durham, NC  27703.
The same ERT file with the CBI omitted must be submitted to EPA via CDX
as described earlier in this paragraph. At the discretion of the
delegated authority, you must also submit these reports, including the
confidential business information, to the delegated authority in the
format specified by the delegated authority.

(ii) All reports required by this subpart not subject to the
requirements in paragraphs (1)(i) and (ii) of this section must be sent
to the Administrator at the appropriate address listed in §63.13. The
Administrator or the delegated authority may request a report in any
form suitable for the specific case (e.g., by commonly used electronic
media such as Excel spreadsheet, on CD or hard copy). The Administrator
retains the right to require submittal of reports subject to paragraph
(1)(i) and (ii) of this section in paper format.

*	*	*	*	*

(c) Annual compliance certifications. For the purpose of annual
certifications of compliance required by 40 CFR part 70 or 71, the owner
or operator of a major or area source subject to this subpart must
certify continuing compliance based upon, but not limited to, the
following conditions:

*	*	*	*	*

(d) If there was a malfunction during the reporting period, the owner or
operator must submit a report that includes the number, duration, and a
brief description for each type of malfunction which occurred during the
reporting period and which caused or may have caused any applicable
emission limitation to be exceeded. The report must also include a
description of actions taken by an owner or operator during a
malfunction of an affected source to minimize emissions in accordance
with §§63.1506(a)(5) and 63.1520(a)(8), including actions taken to
correct a malfunction.

*	*	*	*	*

13. Section 63.1517 is amended by:

a. By revising paragraph( b)(3);

b. By revising paragraph (b)(10);

c. By revising paragraph (b)(16)(i);

d. By adding paragraph (b)(18); and

e. By adding paragraph (c)to read as follows:

§63.1517 Records.

*	*	*	*	*

(b) *	*	*

(3) For each scrap dryer/delacquering kiln/decoating kiln and group 1
furnace, subject to D/F and HCl/HF emission standards with emissions
controlled by a lime-injected fabric filter, records of 15-minute block
average inlet temperatures for each lime-injected fabric filter,
including any period when the 3-hour block average temperature exceeds
the compliant operating parameter value +14 °C (+25 °F), with a brief
explanation of the cause of the excursion and the corrective action
taken.

*	*	*	*	*

 (10) Operating logs for each group 1 sidewell furnace with add-on air
pollution control devices documenting conformance with operating
standards for maintaining the level of molten metal above the top of the
passage between the sidewell and hearth during reactive flux injection
and for adding reactive flux only to the sidewell or a furnace hearth
equipped with a control device for PM, HCl/HF, and D/F emissions.

*	*	*	*	*

 (16) *	*	*

(i) Startup and shutdown plan;

*	*	*	*	*

 (18) For each malfunction for which the owner or operator chooses to
claim coverage under the affirmative defense provisions, the owner or
operator must maintain the following records;

(i) Records of the occurrence and duration of each malfunction of
operation (i.e., process equipment) or the air pollution control
equipment and monitoring equipment.

(ii) Records of actions taken during periods of malfunction to minimize
emissions in accordance with §§63.1506(a)(5) and 63.1520(a)(8),
including corrective actions to restore malfunctioning process and air
pollution control and monitoring equipment to its normal or usual manner
of operation.

 (c) All reports required by this subpart not subject to the
requirements in paragraph (b) of this section must be sent to the
Administrator at the appropriate address listed in §63.13. If
acceptable to both the Administrator and the owner or operator of a
source, these reports may be submitted on electronic media. The
Administrator retains the right to require submittal of reports subject
to paragraph (b) of this section in paper format.

*	*	*	*	*

14. Section 63.1520 is revised to read as follows:

§63.1520 Affirmative defense for exceedance of emission limit during
malfunction.

In response to an action to enforce the standards set forth in this
subpart, you may assert an affirmative defense to a claim for civil
penalties for exceedances of such standards that are caused by
malfunction, as defined at §63.2. Appropriate penalties may be
assessed, however, if you fail to meet your burden of proving all of the
requirements in the affirmative defense. The affirmative defense shall
not be available for claims for injunctive relief.

(a) To establish the affirmative defense in any action to enforce such a
limit, you must timely meet the notification requirements in paragraph
(b) of this section, and must prove by a preponderance of evidence that:

(1) The excess emissions:

(i) Were caused by a sudden, infrequent and unavoidable failure of air
pollution control and monitoring equipment, process equipment, or a
process to operate in a normal or usual manner; and

(ii) Could not have been prevented through careful planning, proper
design or better operation and maintenance practices; and

(iii) Did not stem from any activity or event that could have been
foreseen and avoided, or planned for.

(iv) Were not part of a recurring pattern indicative of inadequate
design, operation, or maintenance; and

(2) Repairs were made as expeditiously as possible when the applicable
emission limitations were being exceeded. Off-shift and overtime labor
were used, to the extent practicable to make these repairs; and

(3) The frequency, amount and duration of the excess emissions
(including any bypass) were minimized to the maximum extent practicable
during periods of such emissions; and

(4) If the excess emissions resulted from a bypass of control equipment
or a process, then the bypass was unavoidable to prevent loss of life,
personal injury, or severe property damage; and

(5) All possible steps were taken to minimize the impact of the excess
emissions on ambient air quality, the environment and human health; and

(6) All emissions monitoring and control systems were kept in operation
if at all possible, consistent with safety and good air pollution
control practices; and

(7) All of the actions in response to the excess emissions were
documented by properly signed, contemporaneous operating logs; and

(8) At all times, the affected source was operated in a manner
consistent with good practices for minimizing emissions; and

(9) A written root cause analysis has been prepared, the purpose of
which is to determine, correct, and eliminate the primary causes of the
malfunction and the excess emissions resulting from the malfunction
event at issue. The analysis shall also specify, using best monitoring
methods and engineering judgment, the amount of excess emissions that
were the result of the malfunction.

(b) Notification. The owner or operator of the affected source
experiencing an exceedance of its emission limit(s) during a
malfunction, shall notify the Administrator by telephone or facsimile
transmission as soon as possible, but no later than two business days
after the initial occurrence of the malfunction, if it wishes to avail
itself of an affirmative defense to civil penalties for that
malfunction. The owner or operator seeking to assert an affirmative
defense, shall also submit a written report to the Administrator within
45 days of the initial occurrence of the exceedance of the standards in
this subpart to demonstrate, with all necessary supporting
documentation, that it has met the requirements set forth in paragraph
(e) of this section. The owner or operator may seek an extension of this
deadline for up to 30 additional days by submitting a written request to
the Administrator before the expiration of the 45 day period. Until a
request for an extension has been approved by the Administrator, the
owner or operator is subject to the requirement to submit such report
within 45 days of the initial occurrence of the exceedance.

*	*	*	*	*

15. Table 1 to Subpart RRR is amended to read as follows:

Table 1 to Subpart RRR – Emission standards for New and Existing
Affected Sources

Affected source/Emission unit	Pollutant	Limit	Units

All new and existing affected sources and emission units that are
controlled with a PM add-on control device and that choose to monitor
with a COM; and all new and existing aluminum scrap shredders that
choose to monitor with a COM or to monitor visible emissions	Opacity	10
Percent

New and existing aluminum scrap shredder	PM	0.01	Gr/dscf

New and existing thermal chip dryer	THC	0.8	lb/ton of feed

	D/Fa	2.5	ug TEQ/Mg of feed

New and existing scrap dryer/delacquering kiln/decoating kilnh

or	PM	0.08	lb/ton of feed

	HCl/HF	0.8	lb/ton of feed

	THC	0.06	lb/ton of feed

	D/Fa	0.25	ug TEQ/Mg of feed

Alternative limits if afterburner has a design residence time of at
least 1 second and operates at a temperature of at least 1400 F	PM	0.08
lb/ton of feed

	HCl/HF	0.8	lb/ton of feed

	THC	0.06	lb/ton of feed

	D/Fa	0.25	ug TEQ/Mg of feed

New or existing sweat furnaceh	D/Fa	0.8	ng TEQ/dscm @ 11% O2 b

New or existing dross-only furnaceh	PM	0.3	lb/ton of feed

New or existing in-line fluxer footnote	HCL/HF	0.04	lb/ton of feed

	PM	0.01	lb/ton of feed

New and existing in-line fluxer with no reactive fluxing

No limit	work practice: no reactive fluxing

New and existing rotary dross cooler	PM	0.04	gr/dscf

New and existing clean furnace (Group 2)

No limit	Work practices: clean charge only and no reactive fluxing

New and existing group 1 melting/holding furnace (processing only clean
charge)c, h 	PM	0.8	lb/ton of feed

	HCL/HF	0.4	lb/ton of feed

or

	10	percent of the HCl upstream of the add-on control device

New and existing group 1 furnacec, h	PM	0.4	lb/ton of feed

	HCL/HF	0.4	lb/ton of feed

or

	10	percent of the HCl upstream of the add-on control device

	D/Fa	15	ug/TEQ/Mg of feed

New and existing group 1 furnace with clean charge onlyh	PM	0.4	lb/ton
of feed

	HCL/HF	0.4	lb/ton of feed

or

	10	percent of the HCl upstream of the add-on control device

	D/Fa	No limit	Clean charge only

New and existing group 1 furnace, uncontrolled for HCl/HF, and using
flux containing fluorineh	Combined HCl and HF	0.40	lb/ton of feed

New and existing secondary aluminum processing unita,d (consists of all
existing group 1 furnaces and existing in-line flux boxes at the
facility, or all simultaneously constructed new group 1 furnaces and new
in-lie fluxers)

PMe

HCl/HF

	D/Fg

	a D/F limit applies to a unit at a major or area source.

b Sweat furnaces equipped with afterburners meeting the specifications
of § 63.1505(f)(1) are not required to conduct a performance test.

c These limits are also used to calculate the limits applicable to
secondary aluminum processing units.

d Equation definitions: LiPM = the PM emission limit for individual
emission unit i in the secondary aluminum processing unit [kg/Mg
(lb/ton) of feed]; Ti = the feed rate for individual emission uniti in
the secondary aluminum processing unit; LtPM = the overall PM emission
limit for the secondary aluminum processing unit [kg/Mg (lb/Ton of
feed)]; LiHCL/HF = the HCL/HF emission limit for individual emission
unit i in the secondary aluminum processing unit [kg/Mg (lb/Ton) of
feed]; LtHCl/HF = the overall HCl/HF emission limit for the secondary
aluminum processing unit [kg/Mg (lb/ton) of feed]; LiD/F = the D/F
emission limit for individual emission unit i [µg TEQ/Mg (gr TEQ/ton)
of feed]; LtD/F = the overall D/F emission limit for the secondary
aluminum processing unit [µg TEQ/Mg (gr TEQ/Ton) of feed]; n = the
number of units in the secondary aluminum processing unit. (Need to
check. These are slightly different that what is in the text of the
rule)

e In-line fluxers using no reactive flux materials cannot be included in
this calculation since they are not subject to the PM limit.

f In-line fluxers using no reactive flux materials cannot be included in
this calculation since they are not subject to the HCL/HF limit.

g Clean charge furnaces cannot be included in this calculation since
they are not subject to the D/F limit.

h During periods of startup and shutdown, affected source is not subject
to numerical emissions limits but must be operated according to the work
practice provisions in section §63.1506(q).

*	*	*	*	*

16. Appendix A to Subpart RRR is amended to read as follows:

Appendix A to Subpart RRR of Part 63 – Applicability of General
Provisions 40 CFR 63, Subpart RRR

Citation	Requirement	Applies to RRR	Comment

§63.1(a)(1)–(4)	General Applicability	Yes.

	§63.1(a)(5)

No	[Reserved].

§63.1(a)(6)–(8)

Yes.

	§63.1(a)(9)

No	[Reserved].

§63.1(a) (10)–(14)

Yes.

	§63.1(b)	Initial Applicability Determination	Yes	EPA retains approval
authority.

§63.1(c)(1)	Applicability After Standard Established	Yes.

	§63.1(c)(2)

Yes	§63.1500(e) exempts area sources subject to this subpart from the
obligation to obtain Title V operating permits.

§63.1(c)(3)

No	[Reserved].

§63.1(c)(4)–(5)

Yes.

	§63.1(d)

No	[Reserved].

§63.1(e)	Applicability of Permit Program	Yes.

	§63.2	Definitions	Yes	Additional definitions in §63.1503.

§63.3	Units and Abbreviations	Yes

	§63.4(a)(1)–(3)	Prohibited Activities	Yes.

	§63.4(a)(4)

No	[Reserved]

§63.4(a)(5)

Yes.

	§63.4(b)–(c)	Circumvention/ Severability	Yes.

	§63.5(a)	Construction and Reconstruction—Applicability	Yes.

	§63.5(b)(1)	Existing, New, Reconstructed Sources—Requirements	Yes.

	§63.5(b)(2)

No	[Reserved].

§63.5(b)(3)–(6)

Yes.

	§63.5(c)

No	[Reserved].

§63.5(d)	Application for Approval of Construction/ Reconstruction	Yes.

	§63.5(e)	Approval of Construction/ Reconstruction	Yes.

	§63.5(f)	Approval of Construction/Reconstruction Based on State Review
Yes.

	§63.6(a)	Compliance with Standards and Maintenance—Applicability
Yes.

	§63.6(b)(1)–(5)	New and Reconstructed Sources—Dates	Yes.

	§63.6(b)(6)

No	[Reserved].

§63.6(b)(7)

Yes.

	§63.6(c)(1)	Existing Sources Dates	Yes	§63.1501 specifies dates.

§63.6(c)(2)

Yes.

	§63.6(c)(3)–(4)

No	[Reserved].

§63.6(c)(5)

Yes.

	§63.6(d)

No	[Reserved].

63.6(e)(1)(i)

No	See 63.1506(A)(5) and 63.1520(a)(8) for general duty requirement.

63.6(e)(1)(ii)

No

	63.6(e)(1)(iii)

Yes

	§63.6(e)(2)	Operation & Maintenance Requirements	Yes	§63.1510
requires plan.

§63.6(e)(3)	Startup, Shutdown Plan	No	Startup and Shutdown Plan Only

§63.6(f)	Compliance with Emission Standards	Yes.

	§63.6(g)	Alternative Standard	No

	§63.6(h)	Compliance with Opacity/VE Standards	Yes.

	§63.6(i)(1)–(14)	Extension of Compliance	Yes.

	§63.6(i)(15)

No	[Reserved].

§63.6(i)(16)

Yes.

	§63.6(j)	Exemption from Compliance	Yes.

	§63.7(a)–(h)	Performance Test Requirements-Applicability and Dates
Yes	Except §63.1511 establishes dates for initial performance tests.

§63.7(b)	Notification	Yes.

	§63.7(c)	Quality Assurance/Test Plan	Yes.

	§63.7(d)	Testing Facilities	Yes.

	§63.7(e)	Conduct of Tests	Yes.

	§63.7(f)	Alternative Test Method	Yes.

	§63.7(g)	Data Analysis	Yes.

	§63.7(h)	Waiver of Tests	Yes.

	§63.8(a)(1)	Monitoring Requirements—Applicability	Yes.

	§63.8(a)(2)

Yes.

	§63.8(a)(3)

No	[Reserved]

§63.8(a)(4)

Yes

	§63.8(b)	Conduct of Monitoring	Yes.

	63.8(c)(1)(i)

No	See 63.843(f) and 63.844(f) for general duty requirement.

§63.8(c)(1)(ii)–(3)	CMS Operation and Maintenance	Yes.

	§63.8(c)(4)–(8)

Yes.

	§63.8(d)	Quality Control	Yes.

	§63.8(e)	CMS Performance Evaluation	Yes.

	§63.8(f)(1)–(5)	Alternative Monitoring Method	No	§63.1510(w)
includes provisions for monitoring alternatives.

§63.8(f)(6)	Alternative to RATA Test	Yes.

	§63.8(g)(1)	Data Reduction	Yes.

	§63.8(g)(2)

No	§63.1512 requires five 6-minute averages for an aluminum scrap
shredder.

§63.8(g)(3)–(5)

Yes.

	§63.9(a)	Notification Requirements—Applicability	Yes.

	§63.9(b)	Initial Notifications	Yes.

	§63.9(c)	Request for Compliance Extension	Yes.

	§63.9(d)	New Source Notification for Special Compliance Requirements
Yes.

	63.9(e)	Notification of Performance Test	Yes.

	§63.9(f)	Notification of VE/Opacity Test	Yes.

	§63.9(g)	Additional CMS Notifications	Yes.

	§63.9(h)(1)–(3)	Notification of Compliance Status	Yes	Except
§63.1515 establishes dates for notification of compliance status
reports.

§63.9(h)(4)

No	[Reserved].

§63.9(h)(5)–(6)

Yes.

	§63.9(i)	Adjustment of Deadlines	Yes.

	§63.9(j)	Change in Previous Information	Yes.

	§63.10(a)	Recordkeeping/Reporting—Applicability	Yes.

	§63.10(b)	General Requirements	Yes	§63.1517 includes additional
requirements. See 63.1517(x),(y) and (z) for recordkeeping of occurrence
and duration of malfunctions and recordkeeping of actions taken during
malfunction.

§63.10(c)(1)	Additional CMS Recordkeeping	Yes.

	§63.10(c)(2)–(4)

No	[Reserved].

§63.10(c)(5)

Yes.

	§63.10(c)(6)

Yes.

	§63.10(c)(7)–(8)

Yes.

	§63.10(c)(9)

No	[Reserved].

§63.10(c)(10)–(13)

Yes.	See 63.1517(e)(4)(xvi) and (xvii)for recordkeeping of malfunctions.

§63.10(c)(14)

Yes.

	§63.10(d)(1)	General Reporting Requirements	Yes.

	§63.10(d)(2)	Performance Test Results	Yes.

	§63.10(d)(3)	Opacity or VE Observations	Yes.

	§63.10(d)(4)–(5)	Progress Reports/Startup, Shutdown, and Malfunction
Reports	Yes.

	§63.10(e)(1)–(2)	Additional CMS Reports	Yes.

	§63.10(e)(3)	Excess Emissions/CMS Performance Reports	Yes	Reporting
deadline given in §63.1516.

§63.10(e)(4)	COMS Data Reports	Yes.

	§63.10(f)	Recordkeeping/Reporting Waiver	Yes.

	§63.11(a)–(b)	Control Device Requirements	No	Flares not applicable.

§63.12(a)–(c)	State Authority and Delegations	Yes.	EPA retains
authority for applicability determinations.

§63.13	Addresses	Yes.

	§63.14	Incorporation by Reference	Yes	ACGIH Industrial Ventilation
Manual for capture/collection systems; and Interim Procedures for
Estimating Risk Associated with Exposure to Mixtures of Chlorinated
Dibenzofurans (CDDs and CDFs) and 1989 Update (incorporated by reference
in §63.1502).

§63.15	Availability of Information/Confidentiality	Yes.

 “Adverse environmental effect” is defined in CAA section 112(a)(7)
as any significant and widespread adverse effect, which may be
reasonably anticipated to wildlife, aquatic life or natural resources,
including adverse impacts on populations of endangered or threatened
species or significant degradation of environmental qualities over broad
areas.

 Although defined as “maximum individual risk,” MIR refers only to
cancer risk. MIR, one metric for assessing cancer risk, is the estimated
risk were an individual to be exposed to the maximum level of a
pollutant for a lifetime.

 U.S. EPA SAB. Risk and Technology Review (RTR) Risk Assessment
Methodologies: For Review by the EPA’s Science Advisory Board with
Case Studies – MACT I Petroleum Refining Sources and Portland Cement
Manufacturing, May 2010.

 U.S. EPA. Revision to the Guideline on Air Quality Models: Adoption of
a Preferred General Purpose (Flat and Complex Terrain) Dispersion Model
and Other Revisions (70 FR 68218, November 9, 2005).

 A census block is generally the smallest geographic area for which
census statistics are tabulated.

 These classifications also coincide with the terms "known carcinogen,
probable carcinogen and possible carcinogen," respectively, which are
the terms advocated in the EPA's previous Guidelines for Carcinogen Risk
Assessment, published in 1986 (51 FR 33992, September 24, 1986). Summing
the risks of these individual compounds to obtain the cumulative cancer
risks is an approach that was recommended by the EPA's SAB in their 2002
peer review of EPA's NATA entitled, NATA - Evaluating the National-scale
Air Toxics Assessment 1996 Data -- an SAB Advisory, available at:
http://yosemite.epa.gov/sab/sabproduct.nsf/214C6E915BB04E14852570CA007A6
82C/$File/ecadv02001.pdf.

 NAS, 2001. Standing Operating Procedures for Developing Acute Exposure
Levels for Hazardous Chemicals, page 2.

 ERP Committee Procedures and Responsibilities. November 1, 2006.
American Industrial Hygiene Association.

 See http://www.tceq.state.tx.us/compliance/field_ops/eer/index.html or
docket to access the source of these data.

 The SAB peer review of RTR Risk Assessment Methodologies is available
at:
http://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668
381/$File/EPA-SAB-10-007-unsigned.pdf.

 Short-term mobility is movement from one micro-environment to another
over the course of hours or days. Long-term mobility is movement from
one residence to another over the course of a lifetime.

 U.S. EPA. National-Scale Air Toxics Assessment for 1996. (EPA
453/R–01–003; January 2001; page 85.)

 IRIS glossary (http://www.epa.gov/NCEA/iris/help_gloss.htm).

 An exception to this is the URE for benzene, which is considered to
cover a range of values, each end of which is considered to be equally
plausible and which is based on maximum likelihood estimates.

 According to the NRC report, Science and Judgment in Risk Assessment
(NRC, 1994) “[Default] options are generic approaches, based on
general scientific knowledge and policy judgment, that are applied to
various elements of the risk assessment process when the correct
scientific model is unknown or uncertain.” The 1983 NRC report, Risk
Assessment in the Federal Government: Managing the Process, defined
default option as “the option chosen on the basis of risk assessment
policy that appears to be the best choice in the absence of data to the
contrary” (NRC, 1983a, p. 63). Therefore, default options are not
rules that bind the Agency; rather, the Agency may depart from them in
evaluating the risks posed by a specific substance when it believes this
to be appropriate. In keeping with EPA’s goal of protecting public
health and the environment, default assumptions are used to ensure that
risk to chemicals is not underestimated (although defaults are not
intended to overtly overestimate risk). See EPA, 2004, An Examination of
EPA Risk Assessment Principles and Practices, EPA/100/B–04/001
available at:

http://www.epa.gov/osa/pdfs/ratf-final.pdf.

 Although defined as “maximum individual risk,” MIR refers only to
cancer risk.  MIR, one metric for assessing cancer risk, is the
estimated risk were an individual exposed to the maximum level of a
pollutant for a lifetime.

 The EPA’s responses to this and all other key recommendations of the
SAB’s advisory on RTR risk assessment methodologies (which is
available at:
http://yosemite.epa.gov/sab/sabproduct.nsf/4AB3966E263D943A8525771F00668
381/$File/EPA-SAB-10-007-unsigned.pdf) are outlined in a memo to this
rulemaking docket from David Guinnup, UESPA/OAQPS entitled, EPA’s
Actions in Response to the Key Recommendations of the SAB Review of RTR
Risk Assessment Methodologies.

***E.O. 12866 Review – Draft (12/30/2011) Do Not Cite, Quote or
Release During Review***

<Page   PAGE  149  of   NUMPAGES   234 >

***E.O. 12866 Review – Draft (12/30/2011) Do Not Cite, Quote or
Release During Review***


[Federal Register Volume 83, Number 53 (Monday, March 19, 2018)]
[Rules and Regulations]
[Pages 11881-11883]
[FR Doc No: 2018-05461]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2018-0096]
RIN 1625-AA08

Special Local Regulation; Clinch River, Oak Ridge, TN

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary special local
regulation for all navigable waters of the Clinch River, extending the
entire width of the river, from mile marker (MM) 49.5 to MM 52.0. This
special local regulation is necessary to provide for the safety of life
on these navigable waters near Oak Ridge, TN during the Cardinal
Invitational Regatta marine event. Entry into, transiting through, or
anchoring within this regulated area is prohibited unless authorized by
the Captain of the Port Sector Ohio Valley (COTP) or a designated
representative.

DATES: This rule is effective from 6 a.m. on March 16, 2018 through 5
p.m. on March 18, 2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0096 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Petty Officer Vera Max, Marine Safety Detachment
Nashville, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Sector Ohio Valley
DHS Department of Homeland Security
FR Federal Register
MM Mile marker
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable. We must
establish this restricted area by March 16, 2018 and lack sufficient
time to provide a reasonable comment period and then consider those
comments before issuing this rule. The NPRM process would delay the
establishment of the special local regulation until after the scheduled
date of the marine event and jeopardize public safety.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying this rule would be
impracticable and contrary to the public interest because immediate
action is necessary to protect persons and property from the dangers
associated with the marine event.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1233. The Captain of the Port Sector Ohio Valley (COTP) has determined
that potential hazards associated with the Oak Ridge Rowing Association
Cardinal Invitational Regatta marine event, occurring from 6 a.m.
through 5 p.m. each day from March 16, 2018 through March 18, 2018,
will be a safety concern for all navigable waters on the Clinch River,
extending the entire width of the river, from mile marker (MM) 49.5 to
MM 52.0. The purpose of this rule is to ensure the safety of life and
vessels on these navigable waters before, during, and after the
scheduled event.

IV. Discussion of the Rule

    This rule establishes a special local regulation from 6 a.m.
through 5 p.m. each day from March 16, 2018 through March 18, 2018 for
all navigable waters of the Clinch River, extending the entire width of
the river, from MM 49.5 to MM 52.0. Enforcement of the regulated area
will occur from 6 a.m. to 5 p.m. daily. The duration of the special
local regulation is intended to ensure the safety of life and vessels
on these navigable waters before, during, and after the scheduled
event. No vessel or person will be permitted to enter the special local
regulated area without obtaining permission from the COTP or a
designated representative. A designated representative is a
commissioned, warrant, or petty officer of the U.S. Coast Guard
assigned to units under the operational control of USCG Sector Ohio
Valley. They may be contacted on VHF-FM Channel 16 or by telephone at
1-800-253-7465. Persons and vessels permitted to enter this regulated
area must transit at their slowest safe speed and comply with all
lawful directions issued by the COTP or the designated representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive Orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive Orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the special local regulation.
The Coast Guard will issue written Local Notice to Mariners and
Broadcast Notice to Mariners via VHF-FM marine channel 16 about the
temporary special local regulation.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
special local regulation, may be small entities, for the reasons stated
in section V. A. above, this rule will not have a significant economic
impact on any vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain

about this rule or any policy or action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it 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. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, which guides the Coast Guard in complying with the
National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and
have determined that this action is one of a category of actions that
do not individually or cumulatively have a significant effect on the
human environment. This rule involves the establishment of a special
local regulation lasting eleven hours on three days extending a
distance of less than three miles that will prohibit entry on all
navigable waters of the Clinch River from MM 49.5 to MM 52.0. It is
categorically excluded from further review under paragraph L63(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

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

List of Subjects in 33 CFR Part 100

    Marine safety, Navigation (water), Reporting and recordkeeping
requirements, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority:  33 U.S.C. 1233.

0
2. Add Sec.  100.35T08-0096 to read as follows:

Sec.  100.35T08-0096  Special Local Regulation; Clinch River, Oak
Ridge, TN.

    (a) Location. The following area is a temporary special local
regulation: All navigable waters of the Clinch River, extending the
entire width of the river, between mile marker (MM) 49.5 and MM 52.0,
Oak Ridge, TN.
    (b) Effective period. This section is effective from 6 a.m. on
March 16, 2018 through 5 p.m. on March 18, 2018.
    (c) Special local regulations.
    (1) Entry into this area is prohibited unless authorized by the
Captain of the Port Sector Ohio Valley (COTP) or a designated
representative. A designated representative is a commissioned, warrant,
or petty officer of the U.S. Coast Guard assigned to units under the
operational control of USCG Sector Ohio Valley.
    (2) Persons or vessels seeking to enter the regulated area must
request permission from the COTP or a designated representative on VHF-
FM channel 16 or by telephone at 1-800-253-7465.
    (3) Persons and vessels permitted to enter this regulated area must
transit at their slowest safe speed and comply with all lawful
directions issued by the COTP or the designated representative.
    (d) Informational broadcasts. The COTP or a designated
representative will inform the public through local notice to mariners
and Broadcast Notices to Mariners of the enforcement period for the
regulated area as well as any changes in the planned schedule.

    Dated: March 12, 2018.
M.B. Zamperini,
Captain, U.S. Coast Guard, Captain of the Port Sector Ohio Valley.
[FR Doc. 2018-05461 Filed 3-16-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 84, Number 249 (Monday, December 30, 2019)]
[Notices]
[Pages 72120-72121]
[FR Doc No: 2019-28160]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2019-0017]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 11 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs) to operate a commercial motor vehicle (CMV) in interstate
commerce. They are unable to meet the vision requirement in one eye for
various reasons. The exemptions enable these individuals to operate
CMVs in interstate commerce without meeting the vision requirement in
one eye.

DATES: The exemptions were applicable on December 3, 2019. The
exemptions expire on December 3, 2021.

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

SUPPLEMENTARY INFORMATION:

I. Public Participation

A. Viewing Documents and Comments

    To view comments, as well as any documents mentioned in this notice
as being available in the docket, go to http://www.regulations.gov/docket?D=FMCSA-2019-0017 and choose the document to review. If you do
not have access to the internet, you may view the docket online by
visiting the Docket Operations in Room W12-140 on the ground floor of
the DOT West Building, 1200 New Jersey Avenue SE, Washington, DC 20590,
between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal
holidays.

B. Privacy Act

    In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On October 31, 2019, FMCSA published a notice announcing receipt of
applications from 11 individuals requesting an exemption from vision
requirement in 49 CFR 391.41(b)(10) and requested comments from the
public (84 FR 58441). The public comment period ended on December 2,
2019, and two comments were received.
    FMCSA has evaluated the eligibility of these applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to, or greater than, the level
that would be achieved by complying with Sec.  391.41(b)(10).
    The physical qualification standard for drivers regarding vision
found in Sec.  391.41(b)(10) states that a person is physically
qualified to drive a CMV if that person has distant visual acuity of at
least 20/40 (Snellen) in each eye without corrective lenses or visual
acuity separately corrected to 20/40 (Snellen) or better with
corrective lenses, distant binocular acuity of a least 20/40 (Snellen)
in both eyes with or without corrective lenses, field of vision of at
least 70[deg] in the horizontal meridian in each eye, and the ability
to recognize the colors of traffic signals and devices showing red,
green, and amber.

III. Discussion of Comments

    FMCSA received two comments in this proceeding. Taylor Deist
submitted a comment disagreeing with the Agency's decision to grant
exemptions to the 11 individuals, citing safety concerns related to
their vision. The basis for granting the exemptions is explained in
Section IV of this document. FMCSA has evaluated each applicant and
determined that granting an exemption is likely to achieve a level of
safety greater than, or equal to, that which would be achieved absent
such exemption.
    Tara Coffey submitted a comment disagreeing with the Agency's
decision to grant exemptions to the 11 individuals, citing safety
concerns related to their vision. The basis for granting exemptions is
explained in Section IV of this document. FMCSA has determined that all
of the individuals listed in this notice meet the criteria required for
an exemption.

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315(b), FMCSA may grant an exemption
from the FMCSRs for no longer than a 5-year period if it finds such
exemption would likely achieve a level of safety that is equivalent to,
or greater than, the level that would be achieved absent such
exemption. The statute also allows the Agency to renew exemptions at
the end of the 5-year period. FMCSA grants medical exemptions from the
FMCSRs for a 2-year period to align with the maximum duration of a
driver's medical certification.

    The Agency's decision regarding these exemption applications is
based on medical reports about the applicants' vision, as well as their
driving records and experience driving with the vision deficiency. The
qualifications, experience, and medical condition of each applicant
were stated and discussed in detail in the October 31, 2019, Federal
Register notice (84 FR 58441) and will not be repeated here.
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their
limitation and demonstrated their ability to drive safely. The 11
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, cataract, complete loss of vision,
corneal scar, glaucoma, optic nerve atrophy, partial optic nerve
atrophy, prosthesis, and retinal detachment. In most cases, their eye
conditions did not develop recently. Six of the applicants were either
born with their vision impairments or have had them since childhood.
The five individuals that developed their vision conditions as adults
have had them for a range of 6 to 25 years. Although each applicant has
one eye that does not meet the vision requirement in Sec.
391.41(b)(10), each has at least 20/40 corrected vision in the other
eye, and, in a doctor's opinion, has sufficient vision to perform all
the tasks necessary to operate a CMV.
    Doctors' opinions are supported by the applicants' possession of a
valid license to operate a CMV. By meeting State licensing
requirements, the applicants demonstrated their ability to operate a
CMV with their limited vision in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. We
believe that the applicants' intrastate driving experience and history
provide an adequate basis for predicting their ability to drive safely
in interstate commerce. Intrastate driving, like interstate operations,
involves substantial driving on highways on the interstate system and
on other roads built to interstate standards. Moreover, driving in
congested urban areas exposes the driver to more pedestrian and
vehicular traffic than exists on interstate highways. Faster reaction
to traffic and traffic signals is generally required because distances
between them are more compact. These conditions tax visual capacity and
driver response just as intensely as interstate driving conditions.
    The applicants in this notice have driven CMVs with their limited
vision in careers ranging for 5 to 72 years. In the past three years,
no drivers were involved in crashes, and no drivers were convicted of
moving violations in CMVs. All the applicants achieved a record of
safety while driving with their vision impairment that demonstrates the
likelihood that they have adapted their driving skills to accommodate
their condition. As the applicants' ample driving histories with their
vision deficiencies are good predictors of future performance, FMCSA
concludes their ability to drive safely can be projected into the
future.
    Consequently, FMCSA finds that in each case exempting these
applicants from the vision requirement in Sec.  391.41(b)(10) is likely
to achieve a level of safety equal to that existing without the
exemption.

V. Conditions and Requirements

    The terms and conditions of the exemption are provided to the
applicants in the exemption document and includes the following: (1)
Each driver must be physically examined every year (a) by an
ophthalmologist or optometrist who attests that the vision in the
better eye continues to meet the standard in Sec.  391.41(b)(10) and
(b) by a certified medical examiner (ME) who attests that the
individual is otherwise physically qualified under Sec.  391.41; (2)
each driver must provide a copy of the ophthalmologist's or
optometrist's report to the ME at the time of the annual medical
examination; and (3) each driver must provide a copy of the annual
medical certification to the employer for retention in the driver's
qualification file, or keep a copy in his/her driver's qualification
file if he/she is self-employed. The driver must also have a copy of
the exemption when driving, for presentation to a duly authorized
Federal, State, or local enforcement official.

VI. Preemption

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

VII. Conclusion

    Based upon its evaluation of the 11 exemption applications, FMCSA
exempts the following drivers from the vision requirement, Sec.
391.41(b)(10), subject to the requirements cited above:

Willie V. Brannon, Jr. (OK)
Benjamin E. Brown (WY)
Charles L. Gaines (NC)
James L. Houser (NE)
Andrew J. Kite III (GA)
Sean P. McSperitt (OR)
Matthew J. Morrison (MD)
Frederick L. PeLong (IA)
Martin S. Reese (CA)
Devin M. Smith (OH)
Anthony C. White (AL).

    In accordance with 49 U.S.C. 31136(e) and 31315(b), each exemption
will be valid for 2 years from the effective date unless revoked
earlier by FMCSA. The exemption will be revoked if the following
occurs: (1) The person fails to comply with the terms and conditions of
the exemption; (2) the exemption has resulted in a lower level of
safety than was maintained prior to being granted; or (3) continuation
of the exemption would not be consistent with the goals and objectives
of 49 U.S.C. 31136(e) and 31315(b).

    Issued on: December 20, 2019.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2019-28160 Filed 12-27-19; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 81, Number 181 (Monday, September 19, 2016)]
[Notices]
[Pages 64166-64167]
[FR Doc No: 2016-22437]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2683]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Data To Support Social and Behavioral Research as Used
by the Food and Drug Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on a generic clearance to collect information
to support social and behavioral research used by FDA about drug
products.

DATES: Submit either electronic or written comments on the collection
of information by November 18, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2683 for ``Data To Support Social and Behavioral Research as
Used by the Food and Drug Administration.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management 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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    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.

Data To Support Social and Behavioral Research as Used by the Food and
Drug Administration--(OMB Control Number 0910--NEW)

    Understanding patients, consumers and health care professionals'
perceptions and behaviors plays an important role in improving FDA's
regulatory decisionmaking processes and communications impacting
various stakeholders. The methods to be employed to achieve these goals
include individual indepth interviews, general public focus group
interviews, intercept interviews, self-administered surveys, gatekeeper
surveys, and focus group interviews. The methods to be used serve the
narrowly defined need for direct and informal opinion on a specific
topic and as a qualitative and quantitative research tool, and have two
major purposes:

    1. To obtain information that is useful for developing variables
and measures for formulating the basic objectives of social and
behavioral research and;
    2. To assess the potential effectiveness of FDA communications,
behavioral interventions and other materials in reaching and
successfully communicating and addressing behavioral change with
their intended audiences.

    FDA will use these methods to test and refine its ideas and to help
develop communication and behavioral strategies research, but will
generally conduct further research before making important decisions
such as adopting new policies and allocating or redirecting significant
resources to support these policies.
    FDA's Center for Drug Evaluation and Research, Center for Biologics
Evaluation and Research, Office of the Commissioner, and any other
Centers or Offices will use this mechanism to test communications and
social and behavioral methods about regulated drug products on a
variety of subjects related to consumer, patient, or healthcare
professional perceptions, beliefs, attitudes, behaviors and use of drug
and biological products and related materials, including, but not
limited to, social and behavioral research, decisionmaking processes,
and communication and behavioral change strategies.
    Annually, FDA projects about 45 social and behavioral studies using
the variety of test methods listed in this document. FDA is requesting
this burden so as not to restrict the Agency's ability to gather
information on public sentiment for its proposals in its regulatory and
communications programs.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                       Average burden
                              Activity                                  Number of      responses per     Total annual     per response     Total hours
                                                                       respondents       respondent       responses        (minutes)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Interviews/Surveys.................................................          20,000                1           20,000               15            5,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: September 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22437 Filed 9-16-16; 8:45 am]
 BILLING CODE 4164-01-P