[Federal Register Volume 80, Number 76 (Tuesday, April 21, 2015)]
[Proposed Rules]
[Pages 22137-22140]
[FR Doc No: 2015-09001]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0363; Directorate Identifier 2014-NE-08-AD]
RIN 2120-AA64

Airworthiness Directives; Rolls-Royce plc Turbofan Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for all Rolls-Royce plc (RR) RB211 Trent 768-60, 772-60, and 772B-
60 turbofan engines. The NPRM proposed to require

inspection of the fan case low-pressure (LP) fuel tubes and clips and
the fuel oil heat exchanger (FOHE) mounts and hardware. The NPRM was
prompted by fuel leaks caused by damage to the fan case LP fuel tube.
This supplemental action revises the NPRM by expanding inspections and
corrective actions, correcting a part number (P/N) and the costs of
compliance, reducing the applicability, providing another method to
comply with certain requirements, and giving credit for certain
previous actions. We are proposing this SNPRM to prevent failure of the
fan case LP fuel tube, which could lead to an in-flight engine
shutdown, loss of thrust control, and damage to the airplane.

DATES: We must receive comments by June 22, 2015.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    For service information identified in this SNPRM, contact Rolls-
Royce plc, Corporate Communications, P.O. Box 31, Derby, England, DE24
8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://www.aeromanager.com. You may view this service information at the FAA,
Engine & Propeller Directorate, 12 New England Executive Park,
Burlington, MA. For information on the availability of this material at
the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0363; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the mandatory continuing airworthiness
information (MCAI), the regulatory evaluation, any comments received,
and other information. The address for the Docket Office (phone: 800-
647-5527) is in the ADDRESSES section. Comments will be available in
the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Wego Wang, Aerospace Engineer, Engine
Certification Office, FAA, Engine & Propeller Directorate, 12 New
England Executive Park, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax:
781-238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this SNPRM. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2014-0363;
Directorate Identifier 2014-NE-08-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this SNPRM. We will
consider all comments received by the closing date and may amend this
SNPRM based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this SNPRM.

Discussion

    We issued an NPRM to amend 14 CFR part 39 by adding an AD that
would apply to the specified products. The NPRM was published in the
Federal Register on July 3, 2014 (79 FR 37965). The NPRM proposed to
require inspection of the fan case LP fuel tubes and clips and the FOHE
mounts and hardware.

Related Service Information under 1 CFR Part 51

    We reviewed RR Alert Non-Modification Service Bulletin (NMSB) No.
RB.211-73-AH522, Revision 2, dated July 18, 2014; RR NMSB No. RB.211-
73-AH837, initial issue, dated September 9, 2014; and RR NMSB No.
RB.211-73-G848, Revision 3, dated June 12, 2014. This service
information describes procedures for inspecting, and replacing if
required, the fan case LP fuel tube and clips, and the FOHE mounts and
hardware. This service information is reasonably available because the
interested parties have access to it through their normal course of
business or see ADDRESSES for other ways to access this service
information.

Actions Since Previous NPRM Was Issued

    Since we issued the NPRM (79 FR 37965, July 3, 2014), RR received
reports of additional failures of clips associated with the LP fuel
tube occurring prior to the next inspection as required by the NPRM. RR
published NMSB No. RB.211-73-AH837, initial issue, dated September 9,
2014, to provide instructions for additional specific visual
inspections, at shorter intervals, of the upper clip attaching feature
and the bracket holding this clip to the oil tank and, based on
inspection results, instructions for corrective actions. The European
Aviation Safety Agency (EASA) also issued EASA AD 2014-0243, dated
November 6, 2014, and EASA AD 2014-0243R1, dated December 10, 2014,
which mandate additional inspections and corrective actions, grant
credit for certain prior inspections, allow a certain in-shop
inspection to serve in lieu of a required visual inspection, and state
that replacing parts as a result of the inspections required by those
EASA ADs, and as described in paragraphs (e)(1), (e)(2), and (e)(3) of
this AD, are not terminating action. We reviewed EASA's changes and
concluded that they are necessary to correct the unsafe condition this
SNPRM addresses. We incorporate EASA's changes into paragraphs (e)(1)
and (e)(4) of this SNPRM.
    In addition to these changes, we made other changes.
    Since we issued the NPRM (79 FR 37965, July 3, 2014), we found that
we referenced a non-existent fan case LP fuel tube P/N in the NPRM.
Specifically, fan case LP fuel tube, P/N FW535776, does not exist. We
changed paragraph (e)(3) of this SNPRM to eliminate the non-existent
part number, replacing it with the correct one for the fan case LP fuel
tube, P/N FW53576.
    We also found that we did not include in our cost estimate an
estimate of the number of engines that we expect will fail the proposed
inspections. We revised our cost estimate in this SNPRM by adding an
estimate of the number of engines that we expect will fail inspection,
and the cost of replacement parts.
    We also found that we did not provide adequate information to
identify the applicable engines affected by this AD. We changed the
Applicability paragraph to specify that certain engine models outfitted
with fan case LP fuel tube, P/N FW53576, when installed by
incorporating either RR production modification 73-F343, or RR Service
Bulletin (SB) No. RB.211-73-F343, Revision 4, dated May 26, 2011, are
affected by this SNPRM.

Comments

    We gave the public the opportunity to participate in developing
this proposed

AD. We received no comments on the NPRM (79 FR 37965, July 3, 2014).

FAA's Determination

    We are proposing this SNPRM because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.
Certain changes described above expand the scope of the NPRM (79 FR
37965, July 3, 2014). As a result, we have determined that it is
necessary to reopen the comment period to provide additional
opportunity for the public to comment on this SNPRM.

Proposed Requirements of This SNPRM

    This SNPRM would require accomplishing the actions specified in the
NPRM, except as discussed in the Actions Since Previous NPRM was Issued
paragraph.

Costs of Compliance

    We estimate that this proposed AD affects about 50 engines
installed on airplanes of U.S. registry. We also estimate that it would
take about 6 hours per engine to comply with this proposed AD. The
average labor rate is $85 per hour. We also estimate that 25 of the
engines will fail the inspection proposed by this AD. Required parts
cost about $4,031 per engine. Based on these figures, we estimate the
cost of this proposed AD on U.S. operators to be $126,275.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have a substantial direct
effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.
    For the reasons discussed above, I certify this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

Rolls-Royce plc: Docket No. FAA-2014-0363; Directorate Identifier
2014-NE-08-AD.

(a) Comments Due Date

    We must receive comments by June 22, 2015.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Rolls-Royce plc (RR) RB211 Trent 768-60,
772-60, and 772B-60 turbofan engines, if fitted with fuel tube, part
number (P/N) FW53576, which was incorporated through RR production
modification 73-F343 or which were modified in service in accordance
with RR Service Bulletin (SB) No. RB.211-73-F343, Revision 4, dated
May 26, 2011, or earlier versions.

(d) Reason

    This AD was prompted by fuel leaks caused by damage to the fan
case low-pressure (LP) fuel tube. We are issuing this AD to prevent
failure of the fan case LP fuel tube, which could lead to an in-
flight engine shutdown, loss of thrust control, and damage to the
airplane.

(e) Actions and Compliance

    Comply with this AD within the compliance times specified,
unless already done.
    (1) Within 800 flight hours (FH) after the effective date of
this AD, and thereafter at intervals not to exceed 800 FH, inspect
the clip at the uppermost fan case LP fuel tube clip position,
CP4881, and support bracket, P/N FW26692. Use Accomplishment
Instructions, paragraph 3.A, of RR Non-Modification Service Bulletin
(NMSB) No. RB.211-73-AH837, initial issue, dated September 9, 2014,
or paragraph 3.A. or 3.B. of RR NMSB No. RB.211-73-AH522, Revision
2, dated July 18, 2014, or earlier versions, to do your inspection.
    (i) If the clip at the uppermost clip position, CP4881, fails
inspection, replace the clip with a part eligible for installation
and, before further flight, inspect the fan case LP fuel tube, P/N
FW53576, for fretting, and clips for cracks or failure, according to
Accomplishment Instructions, paragraph 3.A. of RR NMSB No. RB.211-
73-AH837, initial issue, dated September 9, 2014, or paragraph 3.A.
or 3.B. of RR NMSB No. RB.211-73-AH522, Revision 2, dated July 18,
2014, or earlier versions.
    (ii) If the support bracket, P/N FW26692, fails inspection,
replace the bracket before further flight with a part eligible for
installation and inspect the fan case LP fuel tube, P/N FW53576, and
clips for cracks or failure.
    (2) Within 4,000 FH since new or 800 FH, whichever occurs later,
after the effective date of this AD, and thereafter at intervals not
to exceed 4,000 FH, inspect the fan case LP fuel tube, P/N FW53576,
and clips, and the fuel oil heat exchanger (FOHE) mounts and
hardware, for damage, wear, or fretting. Use paragraph 3.A. or 3.B.,
Accomplishment Instructions, of RR Alert NMSB No. RB.211-73-AH522,
Revision 2, dated July 18, 2014, or earlier versions, to do the
inspection.
    (i) If the fan case LP fuel tube, P/N FW53576, fails inspection,
before further flight, replace the fuel tube and clips with parts
eligible for installation.
    (ii) If any FOHE mount or hardware shows signs of damage, wear,
or fretting, replace the damaged part before further flight with a
part eligible for installation.
    (3) At each shop visit after the effective date of this AD,
inspect the fan case LP fuel tubes, P/Ns FW26589, FW36335, FW26587,
FW53577, and FW53576, and clips, and the FOHE mounts and hardware,
for damage, wear, or fretting. Use paragraphs 3.B.(1) and 3.B.(2) of
RR Alert NMSB No. RB.211-73-AH522, Revision 2, dated July 18, 2014,
or earlier versions, to do the inspection.
    (i) If any fan case LP fuel tube fails inspection, replace the
fuel tube and clips before further flight with parts eligible for
installation.
    (ii) If any FOHE mount or hardware shows signs of damage, wear,
or fretting, replace the damaged part before further flight with a
part eligible for installation.
    (4) If you replace any fan case LP fuel tube, clip, or FOHE
mount or hardware as a result

of the inspections of paragraphs (e)(1), (e)(2), or (e)(3) of this
AD, you must still continue to perform the repetitive inspections of
paragraphs (e)(1), (e)(2), and (e)(3) of this AD.
    (5) Any reports requested in the NMSB accomplishment
instructions referenced in paragraphs (e)(1), (e)(2), and (e)(3) of
this AD are not required by this AD.

(f) Credit for Previous Actions

    If, before the effective date of this AD, you performed the
inspections and corrective actions required by paragraph (e)(2) of
this AD using RR NMSB No. RB.211-73-G848, Revision 3, dated June 12,
2014, or earlier versions, you met the initial inspection
requirements of paragraph (e)(2) of this AD.

(g) Definitions

    For the purposes of this AD:
    (1) An ``engine shop visit'' is the induction of an engine into
the shop for maintenance involving the separation of pairs of major
mating engine flanges, except that the separation of engine flanges
solely for the purposes of transportation without subsequent engine
maintenance is not an engine shop visit.
    (2) The fan case LP fuel tubes and clips, and the FOHE mounts
and hardware, are eligible for installation if they have passed the
inspection requirements of paragraphs (e)(1), (e)(2), and (e)(3) of
this AD.

(h) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
to this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(i) Related Information

    (1) For more information about this AD, contact Wego Wang,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington, MA
01803; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>    (2) Refer to MCAI European Aviation Safety Agency AD 2014-
0243R1, dated December 10, 2014 for more information. You may
examine the MCAI in the AD docket on the Internet at http://www.regulations.gov/#!docketDetail;D=FAA-2014-0363.
    (3) RR Alert NMSB No. RB.211-73-AH522, Revision 2, dated July
18, 2014, and earlier versions; RR NMSB No. RB.211-73-AH837, initial
issue, dated September 9, 2014; and RR NMSB No. RB.211-73-G848,
Revision 3, dated June 12, 2014, and earlier versions; which are not
incorporated by reference in this AD, can be obtained from Rolls-
Royce plc, using the contact information in paragraph (i)(4) of this
proposed AD.
    (4) For service information identified in this proposed AD,
contact Rolls-Royce plc, Corporate Communications, P.O. Box 31,
Derby, England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-
1332-249936; email: http://www.rolls-royce.com/contact/civil_team.jsp; Internet: https://www.aeromanager.com.
    (5) You may view this service information at the FAA, Engine &
Propeller Directorate, 12 New England Executive Park, Burlington,
MA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on April 7, 2015.
Ann C. Mollica,
Acting Directorate Manager, Engine & Propeller Directorate, Aircraft
Certification Service.
[FR Doc. 2015-09001 Filed 4-20-15; 8:45 am]
BILLING CODE 4910-13-P


LOPEZ LABS CO-OPERATIVE

heatkit.com/html/lopez.htm

Summary of 87 Masonry Heater Emissions Tests

Norbert Senf

Masonry Stove Builders

25 Brouse Road, RR 5

Shawville, Québec  J0X 2Y0

(819)647 5092

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK "http://www.heatkit.com"  www.heatkit.com

Summary of 14 Masonry Heater Emissions Tests

Alex Chernov

STOVEMASTER

20655 Shaws Creek Rd

Caledon, Ontario L7K 1L7

 HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
  HYPERLINK "http://www.stovemaster.com"  www.stovemaster.com

July 10, 2010

Table of Contents

  TOC \o "1-3" \h \z \u

  HYPERLINK \l "_Toc266436197"  1.)    Executive Summary	  PAGEREF
_Toc266436197 \h  3

  HYPERLINK \l "_Toc266436198"  2.)	Summary of 87 Masonry Heater
Emissions Tests	  PAGEREF _Toc266436198 \h  4

  HYPERLINK \l "_Toc266436199"  Introduction	  PAGEREF _Toc266436199 \h
4

  HYPERLINK \l "_Toc266436200"  Calibration and Accuracy	  PAGEREF
_Toc266436200 \h  4

  HYPERLINK \l "_Toc266436201"  Notes on the Condar Method	  PAGEREF
_Toc266436201 \h  5

  HYPERLINK \l "_Toc266436202"  Test Results	  PAGEREF _Toc266436202 \h
8

  HYPERLINK \l "_Toc266436203"  3.)	Summary of 14 Masonry Heater
Emissions Tests	  PAGEREF _Toc266436203 \h  13

  HYPERLINK \l "_Toc266436204"  Introduction	  PAGEREF _Toc266436204 \h
13

  HYPERLINK \l "_Toc266436205"  Calibration and Accuracy	  PAGEREF
_Toc266436205 \h  13

  HYPERLINK \l "_Toc266436206"  Test Results	  PAGEREF _Toc266436206 \h
14

  HYPERLINK \l "_Toc266436207"  4.) Discussion	  PAGEREF _Toc266436207
\h  16

  HYPERLINK \l "_Toc266436208"  References	  PAGEREF _Toc266436208 \h
17

Executive Summary

This report summarizes PM emissions testing on 3 masonry heaters, using
Oregon Method 41 (OM-41, or Condar method).

 Data from OMNI-Test is provided, comparing OM-41 with ASTM  E25215-09.

The average PM emissions factor for 103 tests was 1.27 g/kg. The range
was 0.48 – 4.61 g/kg over a wide range of operating and fueling
conditions, which are discussed.

PM emissions rates during the short burn cycles were in the range of 7.5
- 54.7 g/hr. They are not directly comparable to the emissions factors
for reasons that are discussed. Additional data is presented comparing
emissions factors and emission rates as tested in Fairbanks, Alaska for
3 categories of appliances.

Summary of 87 Masonry Heater Emissions Tests

Norbert Senf

Masonry Stove Builders

25 Brouse Road, RR 5

Shawville, Québec  J0X 2Y0

(819)647 5092

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
www.heatkit.com

Introduction

A series of 87 test runs was performed on a single masonry heater,
between 2008 and 2010. The HeatKit model heater is typical of the
majority of heaters being built in North America today, with a
Contraflow design and a large firebox designed to handle a wood charge
of 60 lbs.

Particulate emissions were sampled using Oregon Method 41 (OM-41 or
Condar Method), which uses a portable emissions sampler that
incorporates dilution.

A wide variety of operating parameters was tested, as follows:

Cordwood of various sizes, species and moisture contents. The majority
of tests were conducted with white birch at 20% moisture content, with
the bark left on and only loose bark removed.

Fuel charges varied from 59% to 203% of the 60 lb design load.

Lumber fuel cribs of various configurations, including high and low
moisture and several loading factors and ignition methods.

Various ignition methods, such as bottom, side and top kindling.

Cold and warm fireboxes.

Calibration and Accuracy

This was a low budget study done for in-house research purposes.
Calibration gases were not used. 6” glass filters were used in the
Condar sampler. Filter dessication was not used, since it was determined
by testing that it did not make any appreciable difference.

To allow comparability between tests and avoid inaccuracy, the following
methods were used:

A model Testo 330-2 commercial combustion analyzer, which is widely used
in Europe. It has an auto-calibration routine and self-diagnostics for
leaks, worn chemical cells, etc. Manufacturer’s stated accuracy for O2
is +/-0.2 Vol.%

Extra run time for the combustion analyzer before and after a test to
quantify any drift in the ambient (span) O2 value.

The identical blank filter was weighed before and after each run, to
detect drift in the calibration of the analytical balance, or moisture
or static issues.

Testing to determine that use of a dessicator for the 6” glass filters
did not affect results significantly.

Notes on the Condar Method

The main critique of the Condar method has been that it is a constant
flow sampling method, as opposed to proportional flow in M-5H. There are
some data to suggest that Condar results can still be useful,
particularly for comparison testing of low emissions appliances with a
well defined and repeatable burn cycle.

There are two data points from OMNI-Test from July, 2006 tests on a
Swedish masonry heater, comparing PM emission using Condar, ASTM and ESS
methods as follows:

Table   SEQ Table \* ARABIC  1

OMNI-Test Results

Run	Fuel Moisture (dry basis)	Fuel Weight (dry kg)	Test Length

(hours)	Burn Rate

(dry kg/hr)	Emissions Factor (g/kg)

ASTM	Emissions Rate

(g/hr)

ASTM	Emissions Factor (g/kg)

ESS	Emissions Factor (g/kg)

Condar	Emissions Rate (g/kg)

Condar	Fuel Type

4	10.9	19.0	4.7	4.1	2.7	11.07	2	2.5	10.25	Cordwood

5	20.9	18.0	6.0	3.0	2.7	8.1	2	2.5	7.5	Dimen-sional

There was also a study on pellet stoves conducted in New Zealand in 2005
(Reference 1). A Condar sampler was used to conduct in-home field
testing. As part of the study, comparison testing was done between the
Condar and method AS/NZS 4012/3, which is a laboratory dilution tunnel
method. The correlation was very good, as shown in Figure 1, below.

Figure   SEQ Figure \* ARABIC  1

The Condar sampler used for our testing was part of a study conducted in
2007 at Cold Climate Housing Research Center in Alaska (Reference 2).
Four samplers were run on the same heater. The filter catches between
separate samplers were plus or minus 10%, as shown in Figure 2, below.

Figure   SEQ Figure \* ARABIC  2 . Four Condars sampling the same stove.

Masonry heaters burn in the same 1 g/kg PM range as pellet stoves. The
filter catch is mainly soot, with little or no tar. This can be verified
by a “smell test” on the filters. With only soot on the filters
there is no smell, whereas the aromatics in woodsmoke are detectible by
the human nose even at low concentrations.

Soot is produced from flames, whereas tar is produced from smoldering
(flameless) combustion. In theory, this may allow for simplified
sampling trains for low emissions, non-smoldering appliances such as
masonry heaters and pellet stoves.

Test Results

A summary of test results is presented in Table 2.

Average PM factor for 87 tests was 1.29 g/kg.

If we look only at “normal” conditions by eliminating cold starts,
bottom ignition and cribs, the average PM Factor was 0.97 g/kg for 52
cordwood tests in a conditioned heater.

The two largest separately observed operating variables leading to
significantly higher PM emissions were cold start and bottom ignition.
However, the combination of cold start with bottom ignition was
relatively clean. This may be due to their opposing effects on burn
rate.

For bottom ignition in a cold heater, average PM factor was 1.31 g/kg
for 5 tests. With bottom ignition in a warm heater, 1 cordwood test
yielded 3.25 g/kg and 1 crib test yielded 3.63 g/kg.

The highest PM factor recorded was 4.6 g/kg, using cold white birch
cordwood in a cold heater with no chimney draft and a resulting slow,
smoldering start.

The higherst PM factor in a crib test was 3.61 g/kg, with a large, very
dry crib at 10% moisture in a warm heater, with a kindling crib stacked
underneath. A repeat run with the kindling crib stacked on top resulted
in 1.06 g/kg. This demonstrates the effect that ignition method can have
in cold-to-cold testing.

The average PM factor for 16 crib tests was 1.79 g/kg.

The 52 “normal” runs, averaging 0.97 g/kg, had an average burn rate
of 12.2 kg/hr and an average PM emissions rate of 11.81 g/hr. See
“Discussion” section for a comparison of emissions rate and
emissions factor for a masonry heaters and an EPA stove.

More detailed results, including raw data and detailed fueling data, are
available online at

  HYPERLINK "http://heatkit.com/html/lopez.htm"
heatkit.com/html/lopez.htm

Also available online are various summary pages, such as crib
repeatability testing.

Calculations for the Condar Method were done according to Reference 3.
The calculation spreadsheet is available online.

The column headings in Table 2 (next page) are as follows:

PM g/kg: particulate emissions factor as determined by Oregon  Method
41 (OM-41 or Condar method)

CO emissions factor, using OM-41

Eff: Overall efficiency, using OM-41

Moisture: Wood  moisture, % dry basis

Load : fuel load in lbs. Tests were single load with the following
exceptions:

L02 and L06 – L15 were reloads (2 loads)

Pieces #: Total number of fuel pieces

Sizing: some tests included a surface/volume factor for the fuel pieces

Kindl: weight of kindling in lbs (included in total fuel load)

Cold or warm heater/fuel: CC means cold heater and cold fuel, whereas WW
means warm heater (fired 24 hrs previously) and room termperaturefuel.

Ignition/stacking: default is log cabin stacking with kindling from the
side. Notes if kindling was underneath, fuel was stacked front-to-back,
or if crib fuel was used. Grate was left open for all tests except K01
– K05, where it was accidentally left closed.

The last (unlabelled) column has additional fuel notes, such as
species.Table   SEQ Table \* ARABIC  2 . DATA SUMMARY --Particulates,
Carbon Monoxide and Efficiency for 87 contraflow heater tests

Key:

PM factors less than 1 g/kg are highlighted in green

PM factors between 1 – 2 g/kg are in white

PM factors greater than 2 g/kg are highlighted in brown

Summary of 14 Masonry Heater Emissions Tests

Alex Chernov

STOVEMASTER

20655 Shaws Creek Rd

Caledon, Ontario L7K 1L7

 HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>
www.stovemaster.com

Introduction

A series of 14 test runs was performed on a masonry heater in 2009 -
2010. The tested masonry heater is of the Double Bell design, with size
and layout comparable to the majority of heaters being built in the
North America today. The heater has a large firebox designed to handle a
wood charge of 50 lbs.

Particulate emissions were sampled using Oregon Method 41 (OM-41 or
Condar Method), which uses a portable emissions sampler that
incorporates dilution.

Different firebox configurations and different ways for supplying
primary and secondary combustion air where tested.

Calibration and Accuracy

This was a low budget study done for in-house research purposes.
Calibration gases were not used. 6” glass filters were used in the
Condar sampler. Filter dessication was not used, since it was determined
by testing that it did not make any appreciable difference. Filters were
weighed immediately after test termination.

To allow comparability between tests and avoid inaccuracy, the following
methods were used:

A model Testo 330-1 commercial combustion analyzer, which is widely used
in Europe.  Self-diagnostics was performed before each run.

A sample weight was weighed before and after each run, to detect drift
in the calibration of the analytical balance.

Test Results

A summary of test results is presented in Table 3.

Average PM Factor for 12 cordwood tests was 1.01 g/kg.

With exception of two tests, the tests were performed on a slightly warm
heater (48hrs since the last burn).  With this factor and all variations
in firebox and air supply design, all tests fall in the range of
0.45-1.7g/kg.

Two last tests were performed using a wet hardwood crib with individual
pieces reaching moisture content up to 35% to simulate the worst case
scenario. They generated the highest PM values recorded of 3.5g/kg and
3.8g/kg, in slow, smoldering starts.

The average PM factor from all tests including two wet crib tests was
1.35 g/kg.

More detailed results, including raw data and detailed fueling data are
available upon request, and will be made available online at  HYPERLINK
"http://www.stovemaster.com" www.stovemaster.com  soon.

The column headings in Table 2 (next page) are as follows:

PM g/kg: particulate emissions factor as determined by Oregon  Method
41 (OM-41 or Condar method)

CO emissions factor, using OM-41

Eff: Overall efficiency, using OM-41

Moisture: Wood  moisture, % dry basis

Load : fuel load in lbs. Tests were single loads.

Pieces #: Total number of fuel pieces

Surf/Vol: some tests included a surface/volume factor for the fuel
pieces

Kindling: weight of kindling in lbs (included in total fuel load)

Cold/Warm heater/fuel: CC means cold heater and cold fuel, whereas WW
means warm heater (fired 24 hrs previously) and room termperaturefuel.

Ignition: default is log cabin stacking with kindling from the side.

Species.

Table 3. DATA SUMMARY --Particulates, Carbon Monoxide and Efficiency
for 14 Double Bell heater tests

Run	PM	CO 	Eff.	Moisture	Load 	Pieces	Surf/Vol	Kindling 	Cold/Warm
Ignition	Species

 	g/kg	g/kg	%	%	lbs	 	 	lbs	heater/fuel

Average	1.01	53.76	76.03	19.62	49.44	8.58	3.24	2.2

TL-001	1.11	43.25	73.13	20.50	48.40	8	3.02	2.2	s.warm/w	side	maple

TL-002	1.34	61.75	77.07	17.00	48.50	8	2.96	2.2	s.warm/w	side	maple

TL-004	1.67	74.47	73.99	18.00	49.40	9	3.29	2.2	s.warm/w	side	maple

TL-005	0.98	58.46	77.06	20.90	49.20	8	3.42	2.2	s.warm/w	side	maple

TL-006	0.62	47.85	78.53	20.00	51.00	9	3.29	2.2	warm/w	side	maple

TL-007	0.45	48.55	74.64	20.00	48.70	8	3.09	2.2	warm/w	side	maple

TL-008	0.60	57.80	78.87	20.00	49.00	9	3.45	2.2	s.warm/w	side	maple

TL-009	0.61	49.10	76.20	20.00	49.10	8	3.10	2.2	s.warm/w	side	maple

TL-010	1.35	57.97	75.88	20.00	49.60	10	3.37	2.2	s.warm/w	side	maple

TL-011	1.35	61.70	73.00	18.00	50.00	10	3.61	2.2	s.warm/w	side	maple

TL-012	1.36	48.14	78.00	20.50	50.90	8	2.94	2.2	s.warm/w	side	maple

TL-013	0.66	36.13	76.00	20.50	49.50	8	3.30	2.2	s.warm/w	side	maple

	Wet hardwood crib runs (up to 35% moisture pieces):

TLC-01	3.80	38.69	63.57	24.60	36.00	9	4.07	4.50	s.warm/w	bottom	maple

TLC-02	3.05	44.00	63.52	24.10	36.20	9	4.04	4.50	s.warm/w	bottom	maple

	s.warm - "slightly warm" - 48hrs since last burn.

Key:

PM factors less than 1 g/kg are highlighted in green

PM factors between 1 – 2 g/kg are in white

PM factors greater than 2 g/kg are highlighted in brown

4.)  Discussion

The 52 “normal” HeatKit runs, averaging 0.97 g/kg, had an average
burn rate of 12.2 kg/hr and an average PM emissions rate of 11.81 g/hr.
The 2 hr burn duration on this large (heavy) heater yields a 24 hr
heating time. Thus, the emissions rate is 11.81 g/hr for 8% of the
heating cycle, and 0 g/hr for 92% of the heating cycle, or an averaged
rate of 0.98 g/hr over the heating cycle.

In comparison, the Swedish heater tested by OMNI is lighter, and has a
shorter heating cycle. The fuel load of the Swedish heater averaged 0.64
of the fuel load of the HeatKit. Emissions between the two heaters are
more realistically compared with the emissions factors, than with the
emissions rates. The Condar emissions factor for the Swedish averages
2.57 times that of the HeatKit, but the emissions rate averages 0.72
times. Emissions rate reporting favors smaller heaters, which normally
burn less wood and heat less space.

A 2009 study by Cold Climate Housing Research Center in Fairbanks,
Alaska, measured PM emissions in an EPA wood stove, a masonry heater,
and a multi-fuel pellet stove, and provides the following emissions data
based on assumed daily device use patterns (Reference 4). For the EPA
wood stove, it is assumed that it is “damped down” at night and
fired at high burn rate for the portion of the day when the house is
occupied:

Summary of Emissions for Assumed Daily Device Use Pattern, as Tested

Device	Use Period	Length of Burn      Low Burn rate (hr)	Length of Burn
    High Burn rate (hr)	Weight of Fuel Burned (kg)	Total Heat Delivered
(Btu)	Average Emissions Rate over Heating Cycle (g/hr)	Emissions per
Heat Output (g/100,00 Btu)

EPA Wood stove	Weekend	5	10	28.5	247,747	6.3	34.7

EPA Wood stove	Weekday	5	4	14.6	168,395	9.0	48.5

Masonry Heater	Every Day	NA	4	41.3	521,610	3.5	16.4

Multi-fuel Stove/Barley	Every Day	NA	24	21.8	209,957	3.6	40.6

Multi-fuel Stove/Pellets	Every Day	NA	24	93.2	1,054,322	5.6	12.7

In this study, the EPA stove was certified at 2.6 g/hr. It tested at
CCHRC with local softwood cordwood at 2.3 g/hr at high burn rate, and at
14.5 g/hr at low burn rate. In a less severe climate than the Alaska
interior, it might be expected to operate at low burn for a greater
portion of the heating cycle, which would increase emissions. If the
masonry heater in a milder climate were fired once per day instead of
twice, the average emissions over the 24 hr heating cycle would drop to
1.75 g/hr, at half the heat output.

Low output does not increase emissions as it does with the wood stove in
this study. However, the emissions rate would not reflect this unless it
is allowed to be averaged over the heating cycle.

If EPA were required to set a reasonable g/hr limit for masonry heaters,
these considerations should be taken into account.

References

1.)  “Warm Homes Technical Report: Real-life Emissions Testing of
Pellet Burners in Tokoroa”, New Zealand Ministry for the Environment,
2005

 HYPERLINK
"http://www.mfe.govt.nz/publications/energy/emissions-testing-pellet-bur
ners-tokoroa-jun07/html/index.html"
www.mfe.govt.nz/publications/energy/emissions-testing-pellet-burners-tok
oroa-jun07/html/index.html

2.)    HYPERLINK "http://heatkit.com/research/lopezq.htm"
heatkit.com/research/lopezq.htm

3.)  “Determination of Condensable Particulate Woodstove Emission
Factors Using Condar’s Emissions Sampler”, Stockton Barnett, 1983

 HYPERLINK "http://heatkit.com/docs/condar.PDF"
heatkit.com/docs/condar.PDF

4.) “Support for Developing a Sustainable Fire Load Reduction Program
by Creating and Expanding Wood-Energy Enterprises”, Dave Misiuk, P.E.,
Cold Climate Housing Research Center, Fairbanks, Alaska, 2009.

  PAGE  3

  PAGE  17


[Federal Register Volume 79, Number 234 (Friday, December 5, 2014)]
[Notices]
[Pages 72220-72221]
[FR Doc No: 2014-28545]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73711; File No. SR-OPRA-2013-03]

Options Price Reporting Authority; Order Approving an Amendment
to the Plan for Reporting of Consolidated Options Last Sale Reports and
Quotation Information To Amend Sections 5.4 and 7.1 of the OPRA Plan

December 1, 2014.

I. Introduction

    On October 21, 2013, the Options Price Reporting Authority
(``OPRA'') submitted to the Securities and Exchange Commission
(``Commission''), pursuant to Section 11A of the Securities Exchange
Act of 1934 (``Act'') \1\ and Rule 608 thereunder,\2\ an amendment to
the Plan for Reporting of Consolidated Options Last Sale Reports and
Quotation Information (``OPRA Plan'').\3\ The proposed OPRA Plan
amendment would modify Sections 5.4 and 7.1 of the OPRA Plan as they
relate to operations of OPRA outside of OPRA's regular hours of
operations.\4\ The proposed OPRA Plan amendment was published for
comment in the Federal Register on August 18, 2014.\5\ The Commission
received no comment letters in response to the Notice.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78k-1.
    \2\ 17 CFR 242.608.
    \3\ The OPRA Plan is a national market system plan approved by
the Commission pursuant to Section 11A of the Act and Rule 608
thereunder. See Securities Exchange Act Release No. 17638 (March 18,
1981), 22 SE.C. Docket 484 (March 31, 1981). The full text of the
OPRA Plan is available at http://www.opradata.com. The OPRA Plan
provides for the collection and dissemination of last sale and
quotation information on options that are traded on the participant
exchanges. The twelve participants to the OPRA Plan are BATS
Exchange, Inc., BOX Options Exchange, LLC, Chicago Board Options
Exchange, Incorporated, C2 Options Exchange, Incorporated,
International Securities Exchange, LLC, Miami International
Securities Exchange, LLC, NASDAQ OMX BX, Inc., NASDAQ OMX PHLX LLC,
NASDAQ Stock Market LLC, NYSE MKT LLC, NYSE Arca, Inc., and Topaz
Exchange, LLC (d/b/a ISE Gemini).
    \4\ OPRA's regular hours of operations are from 7:30 a.m. to
6:00 p.m. Eastern time. See Section 5.3 of the OPRA Plan.
    \5\ See Securities Exchange Act Release No. 72820 (August 12,
2014), 79 FR 48779 (``Notice'').
---------------------------------------------------------------------------

    This order approves the proposed OPRA Plan amendment.

II. Description of the Proposal

    The purpose of the proposed amendment is to (1) amend the OPRA Plan
so that it provides for the aggregation of costs for operations of OPRA
outside of its regular hours of operations (``after-hours operations'')
with costs for operations of OPRA during its regular hours of
operations (``regular-hours operations''); and (2) state expressly that
OPRA may establish separate fees for access to OPRA data during periods
of after-hours operations.\6\
---------------------------------------------------------------------------

    \6\ OPRA does not currently operate outside of its regular hours
of operations. However, according to OPRA, one of its member
exchanges has indicated that it is planning to initiate after-hours
trading and requested that OPRA operate during the after-hours
period when its market will be open for trading. The current OPRA
Plan provides that the OPRA System will operate outside of its
regular hours of operation at the request of any one or more of its
member exchanges. See Section 5.3 of the OPRA Plan. OPRA is not
proposing any changes to Section 5.3 of the OPRA Plan.
---------------------------------------------------------------------------

    Currently, the OPRA Plan provides that the costs of OPRA's after-
hour operations are to be allocated separately from the costs of OPRA's
regular-hour operations and in a somewhat different manner. The OPRA
Plan currently provides that the costs of OPRA's regular-hour
operations below a specified ceiling \7\ and OPRA's revenues from
regular-hour operations are both to be allocated among the OPRA member
exchanges on the basis of the relative number of compared trades in
options contracts traded on each of the OPRA member exchanges.\8\
---------------------------------------------------------------------------

    \7\ Clause 7.1(a)(iii)(2) of the OPRA Plan provides that costs
above a ``specified ceiling'' are to be allocated in accordance with
OPRA's Capacity Guidelines. The ``ceiling'' is described in
Guideline 7 of the Capacity Guidelines. OPRA is not proposing any
changes in the allocation of costs as described in the Capacity
Guidelines.
    \8\ See Section 7.1 of the OPRA Plan.
---------------------------------------------------------------------------

    The current provisions of the OPRA Plan state that, if the OPRA
System operates outside of OPRA's regular hours, any costs attributable
to such operation will be allocated to the exchange or exchanges that
are actually operating during the after-hours period. The OPRA Plan
does not make any special provision for the allocation of revenues
derived from fees for access to OPRA data generated in the course of
after-hours operations, and the OPRA Plan therefore provides that these
revenues will be allocated among the OPRA member exchanges in the same
way that revenues derived from regular-hours operations are allocated.
The result is that the OPRA Plan currently provides for the allocation
of costs of after-hours trading only to the exchange or exchanges that
are actually operating during the after-hours period, but for the
allocation of revenues resulting from fees for access to quotation and
last sale information generated in the course of after-hours operations
to all of the OPRA member exchanges on the basis of the relative number
of compared trades in options contracts traded on each of the OPRA
member exchanges in trading during both regular hours and outside of
regular hours.
    OPRA is therefore proposing to revise the OPRA Plan to provide that
the costs of after-hours operations will be aggregated with the costs
of operating the OPRA System during regular hours of operation. As a
result of the proposed change, the aggregated costs of operating the
System during all hours of operation would be allocated among all of
OPRA's member exchanges, regardless of whether any particular exchange
operates its market outside of regular hours.
    In addition, OPRA's Fee Schedule does not currently provide
specific fees for access to OPRA data during periods

of after-hours operations. Therefore, OPRA is proposing to add a
sentence to Section 5.4(d) of the OPRA Plan to state expressly that it
may establish such fees.\9\
---------------------------------------------------------------------------

    \9\ OPRA is also proposing to make a non-substantive change to
Section 5.4(d) of the OPRA Plan to reflect that the OPRA Fee
Schedule is no longer identified as ``Exhibit B'' to the OPRA Plan
but is publicly available on the OPRA Web site under the ``Fees''
tab.
---------------------------------------------------------------------------

III. Discussion

    After careful review, the Commission finds that the proposed OPRA
Plan amendment is consistent with the requirements of the Act and the
rules and regulations thereunder.\10\ Specifically, the Commission
finds that the proposed OPRA Plan amendment is consistent with Section
11A of the Act \11\ and Rule 608 thereunder \12\ in that it is
appropriate in the public interest, for the protection of investors and
the maintenance of fair and orderly markets, and to remove impediments
to, and perfect the mechanisms of, a national market system. OPRA
believes that the proposed amendment will better align the provisions
of the OPRA Plan relating to the allocation of costs of after-hours
operations with the provisions of the OPRA Plan relating to the
allocation of revenues derived from after-hours trading. The Commission
believes that OPRA's proposal is consistent with Section 11A of the Act
\13\ and Rule 608 thereunder.\14\
---------------------------------------------------------------------------

    \10\ In approving this proposed OPRA Plan Amendment, the
Commission has considered its impact on efficiency, competition, and
capital formation. 15 U.S.C. 78c(f).
    \11\ 15 U.S.C. 78k-1.
    \12\ 17 CFR 242.608.
    \13\ 15 U.S.C. 78k-1.
    \14\ 17 CFR 242.608.
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 11A of the Act,\15\
and Rule 608 thereunder,\16\ that the proposed OPRA Plan amendment (SR-
OPRA-2013-03) be, and it hereby is, approved.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78k-1.
    \16\ 17 CFR 242.608.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\17\
---------------------------------------------------------------------------

    \17\ 17 CFR 200.30-3(a)(29).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-28545 Filed 12-4-14; 8:45 am]
BILLING CODE 8011-01-P


PHARMACEUTICALS
1
.  The authority citation for 21 CFR part 211 continues to read as follows:
Authority: 21 U.S.C. 321, 351, 352, 355, 360b, 371, 374; 42 U.S.C. 216, 262, 263a, 264.
2
.
Section 211.116 is added to subpart F to read as follows:
§ 211.116  Use of cattle material.
Use of certain cattle material in drug products and components is prohibited as provided
by §§ 300.200, 500.200, and 600.16 of this chapter.
PART 226--CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED
ARTICLES
3
.  The authority citation for 21 CFR part 226 continues to read as follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
4
.
Section 226.60 is added to subpart C to read as follows:

11
9
§ 226.60 Use of cattle material.
Use of certain cattle material in Type A medicated articles for ruminants is prohibited as
provided by § 500.200 of this chapter.
PART 300--GENERAL
5
.  The authority citation for 21 CFR part 300 is revised to read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360b, 361, 371, 381; 42 U.S.C. 264, 271.
6
.
Section 300.200 is added to subpart C to read as follows:
§ 300.200  Prohibited cattle materials.
(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when
used in this section.  The following definitions also apply:
(1) Prohibited cattle materials means specified risk materials; small intestine of all cattle
except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled
cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited
cattle materials do not include tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.
Prohibited cattle materials also do not include materials obtained from fetal calves of cows that
were inspected and passed, as long as the materials were obtained by procedures adequate to
prevent contamination with specified risk materials.
(2)
Inspected and passed means that the material is from an animal that has been
inspected and passed for human consumption by the appropriate regulatory authority, and at the
time the animal was inspected and passed, it was found to be not adulterated.

12
0
(3) Mechanically separated beef means a meat food product that is finely comminuted,
resulting from the mechanical separation and removal of most of the bone from attached skeletal
muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9
CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the
standard of identity for Mechanically Separated (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken appendages, severed
tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.
(5) Specified risk materials means the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and
older, and the tonsils and distal ileum of the small intestine of all cattle.
(6)  Tallow means the rendered fat of cattle obtained by pressing or by applying any
other extraction process to tissues derived directly from discrete adipose tissue masses or to other
carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle
materials or must contain not more than 0.15 percent insoluble impurities as determined by the
method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil
Chemists’ Society (AOCS), 5
th
Edition, 1997, incorporated by reference in accordance with 5
U.S
.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and
sensitivity to AOCS Official Method Ca 3a-46. You may obtain copies of the method from the
AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be
examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records Administration

12
1
(NARA).  For information on the availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(7)  Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of material obtained by
hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.
(b) Requirements. (1)  At a minimum, except as provided in paragraph (b)(2) of this
section, no drug intended for use in humans shall be manufactured from, or otherwise contain,
prohibited cattle materials obtained from cattle slaughtered on or after [insert effective date of
final rule].
(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle
materials shall not apply if FDA grants written permission for an exception or alternative to such
requirements.
(i)  To obtain written permission from FDA, you must send a written request to the
Director of the Center for Drug Evaluation and Research, Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857.  For a drug subject to an application, your written request
must reference its application number.  The Center Director may also grant written permission
for an exception or alternative to the requirements in paragraph (b)(1) of this section on his own
initiative and shall base such a determination on an evaluation of the criteria described in
paragraph (b)(2)(ii) of this section.  You must maintain a record of any exception or alternative
to the requirements in paragraph (b)(1) of this section that is granted by FDA, in accordance with
paragraph (c) of this section.
(ii)  A written request for an exception or alternative to the requirements in paragraph
(b)(1) of this section must include, for each applicable product:

12
2
(A)  A statement of the reasons why an exception or alternative is needed;
(B)  A description of the product, including the type of prohibited cattle materials used in
its manufacturing, its manufacturing and purification processes, and its route of administration;
(C)  A description of the source of the prohibited cattle materials, including information
on the location where the cattle were born, raised, and slaughtered, and any other information
relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of
this chapter;
(D)  A description of how the requirements in paragraph (b)(1) of this section are not
necessary based on the risks of the prohibited cattle materials in the product and the benefits of
the product or how such restrictions are not necessary to ensure the safety of the product; and
(E)  Any other relevant information.
(iii)  FDA shall respond in writing to all requests for an exception or alternative to the
requirements and may impose conditions in granting any such request.
(3)
The small intestine is not considered prohibited cattle material if the distal ileum is
removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small
intestine, as measured from the caeco-colic junction and progressing proximally towards the
jejunum, or by a procedure that the establishment can demonstrate is equally effective in
ensuring complete removal of the distal ileum.
(c)  Records.  (1) Applicants and manufacturers of a drug that is manufactured from, or
otherwise contains, cattle material must establish and maintain records sufficient to demonstrate
that the material is not manufactured from, and does not contain, prohibited cattle materials.
(2) Records must be retained for at least 1 year after the expiration date of the drug or,
for drugs lacking an expiration date, at least 3 years after distribution of the last lot of the drug.

12
3
(3)
Records must be retained at the applicant’s or manufacturer’s establishment or at a
reasonably accessible location.  Records are considered to be reasonably accessible if they are
accessible from an onsite location.
(4) Records required by this section must be readily available to FDA for inspection and
copying.  All the records must be in English.
(5)
When filing entry with the U.S. Customs and Border Protection, the importer of
record of a drug manufactured from, or otherwise containing, cattle material must affirm that the
drug was manufactured from, or otherwise contains, cattle material and must affirm that the drug
was manufactured in accordance with this section.  If a drug was manufactured from, or
otherwise contains, cattle material, then the importer of record must, if requested, provide to
FDA within 5 days records that are sufficient to demonstrate that the drug is not manufactured
from, and does not contain, prohibited cattle material.
(d) A human drug that is not in compliance with the requirements of paragraph (b) of
this section is adulterated under section 501(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B)).
(e)  Failure of an applicant or manufacturer to comply with the requirements of paragraph
(c) of this section renders a drug adulterated under section 501(a)(2)(B) of the act (21 U.S.C.
351
(a)(2)(B)).
(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of
this section causes a drug to appear to be adulterated under section 801(a) of the act (21 U.S.C.
381
(a)).
(g) A human drug that is a new drug and that is not in compliance with the requirements
of paragraph (b) of this section is in violation of section 505 of the act (21 U.S.C. 355).

12
4
(h) Failure of an applicant or manufacturer to comply with the requirements of paragraph
(c) of this section is a violation of section 301(e) of the act (21 U.S.C. 331(e)).
(i)  Any person who violates the requirements of paragraph (b) or (c) of this section shall
be subject to the penalties provided in section 368 of the Public Health Service Act (42 U.S.C.
271
).
PART 500--GENERAL
7
. The authority citation for 21 CFR part 500 is revised to read as follows:
Authority:  21 U.S.C. 321, 331, 342, 343, 348, 351, 352, 353, 360b, 371, 381; 42 U.S.C.
264
, 271.
8.
New subpart F is added to part 500 to read as follows:
Subpart F--Substances Prohibited From Animal Drugs
Sec.
500
.200
Prohibited cattle materials in drugs intended for use in ruminants.
Subpart F--Substances Prohibited From Animal Drugs
§ 500.200  Prohibited cattle materials in drugs intended for use in ruminants.
(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321) apply to such terms when
used in this section.  The following definitions also apply:
(1) Prohibited cattle materials means specified risk materials; small intestine of all cattle
except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled
cattle; material from cattle not inspected and passed; or mechanically separated beef.
Prohibited
cattle materials do not include tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.

12
5
Prohibited cattle materials also do not include materials obtained from fetal calves of cows that
were inspected and passed, as long as the materials were obtained by procedures adequate to
prevent contamination with specified risk materials.
(2)
Inspected and passed means that the material is from an animal that has been
inspected and passed for human consumption by the appropriate regulatory authority, and at the
time the animal was inspected and passed, it was found to be not adulterated.
(3) Mechanically separated beef means a meat food product that is finely comminuted,
resulting from the mechanical separation and removal of most of the bone from attached skeletal
muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9
CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the
standard of identity for Mechanically Separated (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken appendages, severed
tendons or ligaments, nerve paralysis, fractured vertebral column or metabolic conditions.
(5) Specified risk materials means the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and
older and the tonsils and distal ileum of the small intestine of all cattle.
(6)
Tallow means the rendered fat of cattle obtained by pressing or by applying any other
extraction process to tissues derived directly from discrete adipose tissue masses or to other
carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle
materials or must contain not more than 0.15 percent insoluble impurities as determined by the
method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil

12
6
Chemists’ Society (AOCS), 5
th
Edition, 1997, incorporated by reference in accordance with 5
U.S
.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy, precision, and
sensitivity to AOCS Official Method Ca 3a-46.  You may obtain copies of the method from
AOCS (http://www.aocs.org) 2211 W. Bradley Ave. Champaign, IL 61821.  Copies may be
examined at the Center for Food Safety and Applied Nutrition’s Library, 5100 Paint Branch
Pkwy., College Park, MD 20740, or at the National Archives and Records Administration
(NARA).  For information on the availability of this material at NARA, call<PHONE_NUMBER>, or go
to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(7)  Tallow derivative means any chemical obtained through initial hydrolysis,
saponification, or trans-esterification of tallow; chemical conversion of material obtained by
hydrolysis, saponification, or trans-esterification may be applied to obtain the desired product.
(8) Ruminant means any member of the suborder of animals that has a stomach with four
compartments (rumen, reticulum, omasum, and abomasum) through which feed passes in
digestion.  The suborder includes, but is not limited to, cattle, buffalo, sheep, goats, deer, elk, and
antelopes.
(b)  Requirements. (1) At a minimum, except as provided in paragraph (b)(2) of this
section, no drug intended for use in ruminants shall be manufactured from, or otherwise contain,
prohibited cattle materials obtained from cattle slaughtered on or after [effective date of final
rule].
(2) The requirements in paragraph (b)(1) of this section with respect to prohibited cattle
materials shall not apply if FDA grants written permission for an exception or alternative to such
requirements.

12
7
(i)  To obtain written permission from FDA, you must send a written request to the
Director of the Center for Veterinary Medicine, 7519 Standish Place, Rockville, Maryland
208
55.  For a drug intended for use in ruminants that is subject to a new animal drug application,
your written request must reference its application number.  The Center Director may also grant
written permission for an exception or alternative to the requirements in paragraph (b)(1) of this
section on his own initiative and shall base such a determination on an evaluation of the criteria
described in paragraph (b)(2)(ii) of this section.  You must maintain a record of any exception or
alternative to the requirements in paragraph (b)(1) of this section that is granted by FDA, in
accordance with paragraph (c) of this section.
(ii)  A written request for an exception or alternative to the requirements in paragraph
(b)(1) of this section must include, for each applicable product:
(A)  A statement of the reasons why the exception or alternative is needed;
(B)  A description of the product, including the type of prohibited cattle materials used in
its manufacturing, its manufacturing and purification processes, and its route of administration;
(C)  A description of the source of the prohibited cattle materials, including information
on the location where the cattle were born, raised, and slaughtered, and any other information
relevant to the likelihood of the cattle having ingested material prohibited under § 589.2000 of
this chapter;
(D)(1)  A description of how the requirements in paragraph (b)(1) of this section are not
necessary:
(i) Based on the risks of the prohibited cattle materials in the product to the target animal
and the benefits of the product to the target animal; and

12
8
(ii) To ensure a reasonable certainty of no harm to humans from any food derived from
the target animal to which the product was administered; or
(2) A description of how the requirements in paragraph (b)(1) of this section are not
necessary to ensure the safety of the product with respect to both the target animal and any food
derived from the target animal to which the product is administered; and
(E)  Any other relevant information.
(iii)  FDA shall respond in writing to all requests for an exception or alternative to the
requirements and may impose conditions in granting any such request.
(3)
The small intestine is not considered prohibited cattle material if the distal ileum is
removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small
intestine, as measured from the caeco-colic junction and progressing proximally towards the
jejunum, or by a procedure that the establishment can demonstrate is equally effective in
ensuring complete removal of the distal ileum.
(c)  Records
.
(1) Applicants and manufacturers of a drug intended for use in ruminants
that is manufactured from, or otherwise contains, any cattle material must establish and maintain
records sufficient to demonstrate that the material is not manufactured from, and does not
contain, prohibited cattle materials.
(2) The following record retention periods apply:
(i)  Records for a Type A medicated article intended for use in ruminants that is
manufactured from, or otherwise contains, any cattle material must be retained for at least 2
years after distribution by the manufacturer.

12
9
(ii) Records for a drug intended for use in ruminants, other than a Type A medicated
article, that is manufactured from, or otherwise contains, any cattle material must be retained for
at least 1 year after the expiration date of the drug.
(3)
Records must be retained at the applicant’s or manufacturer’s establishment or at a
reasonably accessible location.  Records are considered to be reasonably accessible if they are
accessible from an onsite location.
(4)
Records required by this section must be available to FDA for inspection and
copying.  All the records must be in English.
(5)
When filing entry with the U.S. Customs and Border Protection, the importer of
record of a drug intended for use in ruminants that was manufactured from, or otherwise
contains, cattle material must affirm that the drug was manufactured from, or otherwise contains,
cattle material and must affirm that the drug was manufactured in accordance with this section. If
a drug was manufactured from, or otherwise contains, cattle material, then the importer of record
must, if requested, provide to FDA within 5 days records that are sufficient to demonstrate that
the drug is not manufactured from, and does not contain, prohibited cattle material.
(d)
A drug intended for use in ruminants that is not in compliance with the requirements
of paragraph (b) of this section is adulterated under section 501(a)(2)(B) of the act (21 U.S.C.
351
(a)(2)(B)).
(e)  Failure of an applicant or manufacturer to comply with the requirements of paragraph
(c) of this section renders a drug intended for use(s) in ruminants adulterated under section
501
(a)(2)(B) of the act (21 U.S.C. 351(a)(2)(B)).

13
0
(f)  Failure of an importer of record to comply with the requirements of paragraph (c) of
this section causes a drug intended for use(s) in ruminants to appear to be adulterated under
section 801(a) of the act (21 U.S.C. 381(a)).
(g) A drug intended for use in ruminants that is a new animal drug and that is not in
compliance with the requirements of paragraph (b) of this section is in violation of section 512 of
the act (21 U.S.C. 360b).
(h) Failure of an applicant or manufacturer to comply with the requirements of paragraph
(c) of this section is in violation of section 301(e) of the act (21 U.S.C. 331(e)).
(i)  Any person who violates the requirements of paragraph (b) or (c) of this section shall
be subject to the penalties provided in section 368 of the Public Health Service Act (42 U.S.C.
271
).
PART 530--EXTRALABEL DRUG USE IN ANIMALS
9
. The authority citation for 21 CFR part 530 is revised to read as follows:
Authority
:  15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 351, 352, 353, 355, 357,
360
b, 371, 379e; 42 U.S.C. 264, 271.
1
0
.  Section 530.41 is amended by removing the word “for” from the section heading,
paragraph (a) introductory text, and paragraph (b) and adding in its place the word “from”; and
by adding paragraph (c) to read as follows:
§ 530.41 Drugs prohibited from extralabel use in animals.
* * * * *
(c) Drugs that contain prohibited cattle material as defined in §§ 300.200(a)(1) and
500
.200
(a)(1) of this chapter are prohibited from extralabel use in ruminants.
11.  Section 530.42 is added to subpart E to read as follows:

13
1
§ 530.42 Labeling requirements for new animal drugs prohibited from extralabel use in animals.
(a) The labeling of any approved new animal drug that is prohibited from extralabel use
in ruminants by § 530.41(c) must bear the statement “Federal law prohibits the extralabel use of
this product in ruminants.”
(b) Failure to comply with the labeling requirements in paragraph (a) of this section
renders a drug misbranded under section 502(a) of the act.
PART 600--BIOLOGICAL PRODUCTS: GENERAL
1
2
.  The authority for 21 CFR part 600 is revised to read as follows:
Authority:  21 U.S.C. 321, 351, 352, 353, 355, 360, 360i, 371, 374, 381; 42 U.S.C. 216,
262
, 263, 263a, 264, 271, 300aa-25.
1
3
.  Section 600.16 is added to subpart B to read as follows:
§ 600.16 Prohibited cattle materials.
(a)  Definitions.  The definitions and interpretations of terms contained in section 201 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), section 351 of the Public Health
Service Act (the PHS Act) (42 U.S.C. 262), and § 600.3 apply to such terms when used in this
section.  The following definitions also apply:
(1) Prohibited cattle materials means specified risk materials; small intestine of all cattle
except as provided in paragraph (b)(3) of this section; material from nonambulatory disabled
cattle; material from cattle not inspected and passed; or mechanically separated beef.  Prohibited
cattle materials do not include tallow that contains no more than 0.15 percent insoluble
impurities, tallow derivatives, hides and hide-derived products, and milk and milk products.
Prohibited cattle materials also do not include materials obtained from fetal calves of cows that

13
2
were inspected and passed, as long as the materials were obtained by procedures adequate to
prevent contamination with specified risk materials.
(2)
Inspected and passed means that the material is from an animal that has been
inspected and passed for human consumption by the appropriate regulatory authority, and at the
time the animal was inspected and passed, it was found to be not adulterated.
(3) Mechanically separated beef means a meat food product that is finely comminuted,
resulting from the mechanical separation and removal of most of the bone from attached skeletal
muscle of cattle carcasses and parts of carcasses, that meets the specifications contained in 9
CFR 319.5, the U. S. Department of Agriculture’s (USDA’s) regulation that prescribes the
standard of identity for Mechanically Separated (Species).
(4) Nonambulatory disabled cattle means cattle that cannot rise from a recumbent
position or that cannot walk, including, but not limited to, those with broken appendages, severed
tendons or ligaments, nerve paralysis, fractured vertebral column, or metabolic conditions.
(5) Specified risk materials means the brain, skull, eyes, trigeminal ganglia, spinal cord,
vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and
lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia of cattle 30 months and
older, and the tonsils and distal ileum of the small intestine of all cattle.
(6)
Tallow means the rendered fat of cattle obtained by pressing or by applying any other
extraction process to tissues derived directly from discrete adipose tissue masses or to other
carcass parts and tissues.  Tallow must be produced from tissues that are not prohibited cattle
materials or must contain not more than 0.15 percent insoluble impurities as determined by the
method entitled “Insoluble Impurities” (AOCS Official Method Ca 3a-46), American Oil
Chemists’ Society (AOCS), 5
th
Edition, 1997, incorporated by reference in accordance with 5


[Federal Register Volume 79, Number 218 (Wednesday, November 12, 2014)]
[Proposed Rules]
[Page 67154]
[FR Doc No: 2014-25947]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 63

[EPA-R06-OAR-2012-0765; FRL-9918-62-Region 6]

National Emission Standards for Hazardous Air Pollutants;
Delegation of Authority to Arkansas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The EPA is proposing to approve, through a ``direct final''
procedure, a request for delegation of the Federal air toxics program
contained within 40 CFR Parts 63 pursuant to Section 112(l) of the
Clean Air Act (Act). The State's mechanism of delegation involves the
straight delegation of certain existing and future Section 112
standards unchanged from the Federal standards. The actual delegation
of authority of individual standards, except standards addressed
specifically in this action, will occur through a mechanism set forth
in a memorandum of agreement (MOA) between the Arkansas Department of
Environmental Quality (ADEQ) and EPA. ADEQ is requesting delegation and
approval to implement and enforce the existing Part 63 standards as
they apply to Part 70 sources, including major and area sources subject
to the Title V (Part 70) permitting requirements. The delegation of
authority under this action does not include CAA Section 112(r).

DATES: Written comments on this proposed rule must be received on or
before December 12, 2014.

ADDRESSES: Comments may be mailed to Mr. Rick Barrett, Air Permits
Section (6PD-R), Environmental Protection Agency, 1445 Ross Avenue,
Suite 1200, Dallas, Texas 75202-2733. Comments may also be submitted
electronically or through hand delivery/courier by following the
detailed instructions in the Addresses section of the direct final rule
located in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Mr. Rick Barrett,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of this Federal
Register, EPA is approving ADEQ's request for delegation of authority
to implement and enforce certain NESHAPs for all sources which are
subject to part 70 as a direct rule without prior proposal because the
Agency views this as noncontroversial action and anticipates no adverse
comments. A detailed rationale for this proposed approval is set forth
in the direct final rule. If no relevant, adverse comments are received
in response to this action no further activity is contemplated. If EPA
receives relevant, adverse comments, the direct final rule will be
withdrawn and all public comments received will be addressed in a
subsequent final rule based on this proposed rule. EPA will not
institute a second comment period. Any parties interested in commenting
on this action should do so at this time.
    For additional information, see the direct final rule which is
located in the rules section of this Federal Register.

    Dated: October 14, 2014.
Ron Curry,
Regional Administrator, Region 6.
[FR Doc. 2014-25947 Filed 11-10-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 46 (Thursday, March 8, 2012)]
[Notices]
[Pages 14020-14021]
[FR Doc No: 2012-5633]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0197]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Emergency Shortages Data Collection System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the Emergency Shortages Data
Collection System.

DATES: Submit either electronic or written comments on the collection
of information by May 7, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<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.

Emergency Shortages Data Collection System--Section 903(d)(2) of the
Federal Food, Drug, and Cosmetic Act (OMB Control Number 0910-0491)--
Extension

    Under section 903(d)(2) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 393(d)(2)), the Commissioner of Food and
Drugs is authorized to implement general powers (including conducting
research) to carry out effectively the mission of FDA. Subsequent to
the events of September 11, 2001, and as part of broader

counterterrorism and emergency preparedness activities, FDA's Center
for Devices and Radiological Health (CDRH) began developing operational
plans and interventions that would enable CDRH to anticipate and
respond to medical device shortages that might arise in the context of
Federally declared disasters/emergencies or regulatory actions. In
particular, CDRH identified the need to acquire and maintain detailed
data on domestic inventory, manufacturing capabilities, distribution
plans, and raw material constraints for medical devices that would be
in high demand, and/or would be vulnerable to shortages in specific
disaster/emergency situations or following specific regulatory actions.
Such data could support prospective risk assessment, help inform risk
mitigation strategies, and support real-time decisionmaking by HHS
during actual emergencies or emergency preparedness exercises.
    FDA developed ``The Emergency Medical Device Shortages Program
Survey'' in 2002 to support the acquisition of such data from medical
device manufacturers. In 2004, CDRH changed the process for the data
collection, and the electronic database in which the data were stored
was formally renamed the ``Emergency Shortages Data Collection System''
(ESDCS). Recognizing that some of the data collected may be
commercially confidential, access to the ESDCS is restricted to members
of the CDRH Emergency Shortage Team (EST) and senior management with a
need-to-know. At this time, the need-to-know senior management
personnel are limited to two senior managers. Further, the data are
used by this defined group only for decisionmaking and planning in the
context of a Federally declared disaster/emergency, an official
emergency preparedness exercise, or a potential public health risk
posed by non-disaster-related device shortage.
    The data procurement process consists of an initial scripted
telephone call to a regulatory officer at a registered manufacturer of
one or more key medical devices tracked in the ESDCS. In this initial
call, the EST member describes the intent and goals of the data
collection effort and makes the specific data request. After the
initial call, one or more additional followup calls and/or electronic
mail correspondence may be required to verify/validate data sent from
the manufacturer, confirm receipt, and/or request additional detail.
Although the regulatory officer is the agent who the EST member
initially contacts, regulatory officers may designate an alternate
representative within their organization to correspond subsequently
with the CDRH EST member who is collecting or verifying/validating the
data.
    Because of the dynamic nature of the medical device industry,
particularly with respect to specific product lines, manufacturing
capabilities, and raw material/subcomponent sourcing, it is necessary
to update the data in the ESDCS at regular intervals. The EST makes
such updates on a regular basis, but makes efforts to limit the
frequency of outreach to a specific manufacturer to no more than every
4 months.
    The ESDCS will only include those medical devices for which there
will likely be high demand during a specific emergency/disaster, or for
which there are sufficiently small numbers of manufacturers such that
disruption of manufacture or loss of one or more of these manufacturers
would create a shortage.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
     Section of the FD&C Act         Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per  response
----------------------------------------------------------------------------------------------------------------
903(d)(2).......................             125               3             375             0.5             188
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA based the burden estimates in table 1 of this document on past
experience with direct contact with the medical device manufacturers
and anticipated changes in the medical device manufacturing patterns
for the specific devices being monitored. FDA estimates that
approximately 125 manufacturers would be contacted by telephone and/or
electronic mail 3 times per year either to obtain primary data or to
verify/validate data. Because the requested data represent data
elements that are monitored or tracked by manufacturers as part of
routine inventory management activities, it is anticipated that for
most manufacturers, the estimated time required of manufacturers to
complete the data request will not exceed 30 minutes per request cycle.

    Dated: March 2, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-5633 Filed 3-7-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 85, Number 121 (Tuesday, June 23, 2020)]
[Notices]
[Page 37648]
[FR Doc No: 2020-13473]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL20-53-000]

Grand River Dam Authority; Notice of Request for Waiver

    Take notice that on June 16, 2020, pursuant to Rule 207(a)(5) of
the Federal Energy Regulatory Commission's (Commission) Rules of
Practice and Procedure, 18 CFR 385.207(a)(5), the Grand River Dam
Authority submitted a request that the Commission waive the requirement
that Delivery Point Transfers under section 31.2e of the Southwest
Power Pool's Open Access Transmission Tariff must occur between two
different Transmission Customers, as more fully explained in its
request.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://ferc.gov) using the
eLibrary link. Enter the docket number excluding the last three digits
in the docket number field to access the document. At this time, the
Commission has suspended access to the Commission's Public Reference
Room, due to the proclamation declaring a National Emergency concerning
the Novel Coronavirus Disease (COVID-19), issued by the President on
March 13, 2020. For assistance, contact the Federal Energy Regulatory
Commission at<EMAIL_ADDRESS>or call toll-free, (886) 208-
3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    Comment Date: 5:00 p.m. Eastern time on July 7, 2020.

    Dated: June 17, 2020.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2020-13473 Filed 6-22-20; 8:45 am]
BILLING CODE 6717-01-P


MEMORANDUM

DATE: 	May 1, 2023

FROM: 	Patrick Miller (USEPA Region V) and Donna Lee Jones (USEPA OAQPS), U.S. Environmental Protection Agency

TO: 		Coke Ovens Residual Risk and Technology Review (RTR) Project File
--------------------------------------------------------------------------------

--------------------------------------------------------------------------------
SUBJECT:	Soaking Emissions from Coke Ovens: Mountain State Carbon LLC, Follansbee, WV, Inspection June 15-16, 2021
--------------------------------------------------------------------------------

INTRODUCTION

      The purpose of this memorandum is to describe information about coke oven soaking emissions obtained during a recent inspection by U.S. Environmental Protection Agency staff in Region V of a coke battery at the Mountain State Carbon LLC coke manufacturing facility in Follansbee, WV (hereafter referred to as "Mountain State"). A technical description of emissions from soaking at coke by-product ovens in general also is included here.

BACKGROUND

      Soaking emissions are uncaptured coke oven gas regularly vented to the atmosphere as part of normal operations associated with pushing and can be a source of high opacity. The National Emissions Standards for Hazardous Air Pollutants (NESHAP) at 40 C.F.R. part 63, subpart CCCCC, for Coke Ovens: Pushing, Quenching, and Battery Stacks, hereafter referred to as Coke 5C NESHAP, defines soaking as that period in the coking cycle that starts when an oven is dampered-off from the collecting main and is vented to the atmosphere through an open standpipe prior to pushing coke from the oven and ends when the coke begins to be pushed from the oven, during which time the standpipe remains open and until the oven is charged. The standpipe is then closed when the oven is connected to the collecting main duct during charging and coking. Soaking emissions are the discharge of visible emissions from an open standpipe during the period when the oven is being readied to be pushed and is due to either incomplete coking in the coking cycle or leakage into the open standpipe from the collecting main, which collects the coke oven gas from every oven.

SOAKING AT MOUNTAIN STATE CARBON, FOLLANSBEE, WV

      Representatives from Mountain State explained their operations prior to pushing an oven. First, the facility dampers the oven to be pushed from the collecting main prior to opening the standpipe cap to isolate the oven from the collecting main. The common practice at this facility is to damper off and open the standpipe caps for the next three ovens to be pushed at the same time as opposed to dampering off only the next oven to be pushed before opening the standpipe of the oven  being pushed, or to not damper off any other oven. This practice at Mountain State results in significant emissions of raw coke oven gas from the standpipe cap of the oven to be pushed that are not evaluated by topside workers.

      The emissions from the standpipe cap from the ovens to be pushed during soaking at Mountain State would last anywhere from a few seconds to a few minutes. The amount of time between the opening of the standpipe of the oven to be pushed and pushing of the oven is an undetermined amount of time if other issues or delays require topside workers' attention to veer away from the ovens to be pushed. Topside workers are not in a position to evaluate soaking emissions when multiple ovens are dampered off from the collecting main and the standpipe cap is opened. By the time facility personnel arrive at an individual oven that is soaking prior to pushing or before the next ovens are pushed, the standpipe caps could have vented raw coke oven gas with actions required by the current rule for the Coke Ovens: Pushing Quenching, and Battery Stack NESHAP at § 63.7294.

      During the U.S. EPA inspection by EPA Region V personnel on the above date at Mountain State, visible emission observations were conducted during pushing. The contractor who conducts visible emission observations for the facility informed the EPA staff that soaking emissions were considered interference and not read as part of the visible emission observation of ovens being pushed, at the facility.

      The Coke 5C NESHAP (at § 63.7294) requires a facility to determine the cause of soaking emissions that do not ignite automatically, including emissions that result from raw coke oven gas leaking from the collecting main through the damper  and emissions from an oven that result from incomplete coking in the previous coking cycle. The soaking emissions witnessed onsite by EPA staff at Mountain State did not ignite automatically nor were facility personnel present to manually ignite the soaking emissions. There is no opacity limit for soaking emissions currently in the Coke 5C NESHAP. The head space volume of coke ovens at Mountain State is approximately 80 cubic feet (12 inches of head space above coke x 607 inches long x 19 inches wide). The pushing schedule during the EPA inspection indicated that 60 ovens would be pushed over a 24-hour period resulting in approximately 4,800 cubic feet of coke oven gas vented to the atmosphere (1,752,000 cubic feet annually).

CONCLUSIONS

      The venting of soaking emissions occurs regularly enough at coke oven facilities that a secondary collecting main could be used to route emissions to a separate air pollution control device. Amendments to the Coke 5C NESHAP could require a separate air pollution control device with an associated limit and/or include an opacity limit for soaking emissions, which could be averaged over an appropriate period of time to reflect the nature of the operations and which would be required to occur as soon as the oven standpipe cap is opened. Work practice standards also could be added to the rule to include a corrective action requirement triggered by failure to meet the opacity limit and which could be required to be done after opacity greater than the limit is measured. This work practice would replace the current subjective determinations made by facility personnel during the course of typical coke oven operations.