AQ_F_3200000_20210211_PRMT_PAD

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ROY COOPER
Governor ~~
MICHAELS. REGAN
Secretwy
MICHAEL A. ABRACZINSKAS
Director
NORTH CAROLINA
Environmental Quality
February 11, 2021
Mr. Lloyd Smith
Senior EHS Manager
Alcami Corporation Minocycline PTS Process
2320 Scientific Park Drive
Wilmington, NC 28405
SUBJECT: Pennit Applicability Detennination
Applicability Detennination No. 3622
Alcami Corporation Minocycline PTS Process
Morrisville, Durham County
Dear Mr. Smith:
The Division of Air Quality received your February 2, 2021 request that the Raleigh Regional Office
<letennine whether an Air Quality Pennit is necessary for the following emission sources:
•Nlinocycline PTS Process (MPTS) (NESHAP Subpart VVVVVV)
•Natural Gas-Fired Emergency Generator (300-kilowatt maximum output) (NSPS Subpart JJJJ;
NESHAP Subpart ZZZZ)
In light of the infonnation provided, personnel of the Division of Air Quality have revie\ved your
letter relative to applicability to Air Quality Pennits, and our detenninations are listed as follows:
• Minocycline PTS Process (MPTS) is exempt from Air Quality Pennits under regulation 2Q
.0 l 02 (h)(S) for any sources whose potential uncontrolled emissions of particulate matter
(PM l 0), sulfur dioxide, nitrogen oxides, volatile organic compounds, and carbon monoxide
shall each be no more than five tons per year. Although the source is exempt from air quality
pcnnitting, it is still subject to Federal Rule 40 CFR 63 ( ES HAP) Subpart VVVVVV.
•Natural Gas-Fired Emergency Generator (300-kilO\vatt maximum output) is exempt from Air
Quality Penni ts under regulation 2Q .0 l 02 (h)(S) for any sources whose potential uncontrolled
emissions of particulate matter (PM I 0), sulfur dioxide, nitrogen oxides, volatile organic
compounds, and carbon monoxide shall each be no more than five tons per year. Although the
source is exempt from air quality permitting, it is still subject to Federal Rules 40 CFR 60
(NSPS) Subpart JJJJ and 40 CFR 63 (NESHAP) Subpart ZZZZ.
Therefore, this Office has dctennined that an Air Quality Pennit is not required for the
aforementioned sources. It should be noted that this exemption from the pennitting requirement docs
not ~ exempt Alcami Corporation Minocyclinc PTS Process from complying ~.DE Q~ with the applicable emission control standards.
0.-;artmt!d.'CII t'"'1'-u:,w,111t~ Quai~ ~
· ~ No11h Carohna Dcpa11m.:nt of Envirunmcnt.tl Qualil~ Di, ision of Air Qu,iht)
R,ilcigh Rcgion,ll Ollicc 3800 8J1Tctl Dnvc R,ik igh. i',C 27609
919.791 4200T 919.8812261 F
....
It should be noted that any emissions resulting for these sources must be accounted for on all facility
wide emission summaries.
Furthennore, should you decide to modify the process such that the result is an increase of emissions
of air pollutants including toxic air pollutants, an Air Quality Permit may be required, and Alcami
Corporation Minocycline PTS Process should submit a pennit application to this Office prior to such
actions.
It should also be noted that future Regulations including Federal Maximum Achievable Control
Technology (MACT) for hazardous air pollutant (HAP) may be promulgated and adopted by the
Division which apply to this type of manufacturing facility. 1 f so Alcami Corporation Minocycline
PTS Process may be required to apply for an Air Quality Pennit for this equipment at that date.
This exemption from the permitting requirement is based upon your statement that equipment has
been and will be operated under the threshold levels as outlined in the Regulation. Please be advised
that the operation of any air pollution emission sources which results in emissions in excess of the
threshold levels without an Air Quality Penn it is a violation of 15A NCAC 2Q.0 l O l, "Required Air
Quality Penni ts." If this facility is required to obtain an Air Quality Permit for this equipment in the
future because of required emissions, each day of operation of the emission sources without an Air
Quality Pennit represents a separate violation. Such violations may be subject to enforcement action
pursuant to NCGS 143-215.l l4A.
If you have any questions, with reference to the above matter. please do not hesitate to contact Mary
Rose Fontana Lee at 919-791-4272.
cc: Raleigh Regional Office
~Q~9~
Qcp1~:tlfffloifCll'IINl411.ll~li'!J ~
Sincerely,
/
·1 -:/-.:.._.,,.,......
William T. Wike, Jr., Acting Regional Supervisor
Division of Air Quality, NCDEQ
North Carolina Dcpanmcnt of Environmental Quality I Di, ision of Air Quality
Raleigh Regional Ollicc 3800 B,mell Drive I Rakigh, ;,,;c 27609
919.791.4200 T 919.881.2261 F
/
(}alcami.
January 29, 2020
Mr. Will Wike
Regional Supervisor, Wilmington Regional Office
NC Dept ofEnvironmenrnf Quulit:
FEB O 2 2021
Raleigh Regional Office
North Carolina Department of Environmental Quality, Division of Air Quality
3800 Barrett Drive
Raleigh, NC 27609
RE: North Carolina Air Permitting; Alcami Corporation Minocycline PTS Process,
Morrisville, Durham Co., North Carolina
Dear Mr. Wike:
Alcami Corporation is a pharmaceutical contract manufacturer with operations in Morrisville,
NC, Wilmington, NC, and Charleston, SC. We wish to inform the North Carolina Division of Air
Quality (DAQ) of plans to construct and operate a Minocycline PTS Process {MPTS) and a 300
kW natural gas-fired emergency engine and generator at 419 Davis Drive, Suite 300,
Morrisville, North Carolina. The information presented herein addresses the air permitting
implications to operate this equipment in North Carolina.
Minocycline PIS Process
The MPTS is a small, batch chemical-compounding process for manufacturing minocycline PTS
microspheres. Minocydine PTS microspheres are then used to manufacture pharmaceutical
tetracycline antibiotic products at other locations. The process combines methylene chloride
(MeCI), dimethicone, and cyclomethicone in a reaction vessel to produce the microspheres. The
microspheres are then transferred to small dryers for an extensive drying period before the
final product is collected. Alcami will process six to eight ( 6-8) MPTS batches per year. Each
batch will use virgin MeCI (methylene chloride) pulled from several 22 liter (5.8 gallon) closed
head stainless steel containers during batch processing, with waste returned to empty 55
gallon drums. After completion of the manufacturing process, additional MeCI will be used to
clean process vessels, again with waste returned to the empty drums.
Alcami contracted Mitchell Scientific, Inc. to model emissions from the planned MPTS process
using the Emission Master Model® Software (Master), which is based on the USEPA's .fill£
Guidance Document "Methods for Estimating Air Emissions from Chemical Manufacturing
Facilities" (Chapter 16). Emission Master's foundation is built from mathematical models which
allow the program to correctly calculate emissions produced through different phases of a
batch process. A partial list of process models includes: Empty Vessel Purge, Vacuum
Operation, Solids Drying, Holding, Filling, Purging, Heating, Combustion, Factor Based,
ALCAMI CORPORATION 2320 Soent,fic Park Drive Wilmington, NC 28405 •I 800.575 4724 www.alcarntnow.COtl'
Qalcarni
Depressurization. Gas Evolution, Reaction and Fixed Roof Storage Tanks. Master was
customized to calculate emissions from Alcami's MPTS process arrangement, vessel type/size,
process materials, and process steps (pressure, temperature, duration, etc.). The MPTS Master
results output is attached to this letter and indicates total voe emissions of 5.80 lb/batch. Of
this, 5. 77 pounds are MeCl and 0.03 pounds are cyclomethicone (Attachment A -Master
Summary). Each batch will take approximately 142 hours of processing time (setup,
processing, cleaning, and turnaround). Based on this information, uncontrolled actual and
potential emission rates can therefore be calculated as follows:
Actual: 8 batch/yr x 5.80 lb VOC/batch = 46.4 lb VOC/yr or 0.02 ton VOC/yr
Potential: 8760 hr /yr x batch/142 hr x 5.80 lb VOC/batch = 357.8 lb VOC/yr or 1.80 ton
VOC/yr
Based on our understanding of 15A NCAC 2Q .0102 (h)(S), miscellaneous sources having a
potential, uncontrolled VOC emission rate less than 5 ton/yr are exempt from requiring a
permit to construct and operate in North Carolina. With calculated voe emission rates below
this threshold, a permit to construct and operate the MPTS process will not be required.
Alcami operates a nearly identical MPTS process at our operations in Wilmington, North
Carolina. Master was also used to calculate emissions from that process resulting in similar
emission levels. Communications with the DAQ Wilmington Regional Office confirmed that the
process did not require a permit to construct and operate, however, it is subject to 40 CFR Part
63 National Emission Standards for Hazardous Air Pollutants for Chemical Manufacturing Area
Sources (Subpart VVVVVV). Therefore, the MPTS process in Morrisville will also be subject to
Subpart VVVVVV. For your information, attached to this letter is a preliminary Notice of
Compliance Demonstration table that will be submitted to the DAQ as required by Subpart
VVVVVVafter startup in April 2021 (Attachment B -Preliminary NOCS Table).
300 kW Natural Gas-Fired Emergency Eneine
Alcami has installed and will operate a 300 kW natural gas-fired engine and generator to
provide electrical backup power support of our operations (Attachment C -Engine Specs). A
review of Chapter 3.2 of the USEPA AP-42 indicates NOx is the controlling compound for gas-
fired internal engines with an emission factor of 4.08 lb NOx/MMBtu (Table 3.2-2, 4-Stroke,
Lean-Bum). Based on potential annual operation of 500 hr/yr per USEPAguidance for
emergency engines, the uncontrolled, potential emission rate can be calculated as follows:
ALCAMI CORPORATION 2320 Sc:ent1/1c f>ark D1ive Wrlming.on, NC 28405 • I 800 575 4124 www.alcaminow com
Qatcami
4,459 ft3/h (100% load) x 4.08 lb NOx/MMBtu x 0.001020 MMBtu/ft3 x 500 h/yr =
9,278 lb NOx/yr or 4.6 ton NOx/yr
Based on our understanding of 15A NCAC 2Q .0102 (h)(S), miscellaneous sources having a
potential, uncontrolled NOx emission rate less than 5 ton/yr are exempt from requiring a
permit to construct and operate in North Carolina. With calculated NOx emission rates below
this threshold, a permit to construct and operate the 300 kW natural gas-fired emergency
engine will not be required.
Alcami respectfully requests communication from the DAQ that you concur with our
understanding of installing and operating this equipment. Please call me at [phone].
You may also contact Mr. Gary Yoder of the ClimeCo Corporation at [phone].
A BestRegard~: 1~ ~£
q.,~ ,{__ ~CZ:
Lloyd A. Smith
Senior EHS Manager
Alcami Corporation
Enc (3)
ALCAMI CORPORATION :n20 Soentific: Pulk Orivi! Wilmington, NC 28405 • l 800 575,417.4 WWW alcaminow.com
Attachment A
Supporting Emission Master Output
Alcami Corporation
Morrisville, North Carolina
Product:
Process Name:
Production Quantity:
Process Cycle Time:
Date:
File:
Minocycline PTS Microspheres (29.25% w/w)
Minocycline PTS Microspheres (29.25% w/w)
1.6 kg
126.0667 hr
12/3/2020
Alcami Morrisville Minocycline PTS Microspheres
Comments: Process model prepared from document '2001-01 all' nad asjusting model from 2018-10-05
Emissions Emissions Emissions
Comoound Activities Emitting Uncontrolled (lb) Controlled (lb) Percent Removal
Cyclomethicone 5 53 0.030421851 0.030421851 0
Dimethicone 53 0 0
Methylene Chloride 50 5.768087166 5.768087166 0
Minocvcline Hvdrochloride 8 0 0
Minocycline PTS Microsphen 34 0 0
Nitrogen 116 23.19268349 23.19268349 0
Polv(D, L-lactide-co-alvcolide' 44 0 0
Process Cvcle Compound Emission Compound Emission Max Rate (lb/hr)
Comoound Average (lb/hr) Hours Average (lb/hr) Within 1 hour
Cvclomethicone 5 0.000241316 120.6433333 0.000252164 0.012683945
Dimethicone 0 120.5108333 0 0
Methylene Chloride 0.045754261 10.06333333 0.573178586 3.714912485
Minocycline Hydrochloride 0 4 0 0
Minocycline PTS MicrospherE 0 116.6786111 0 0
Nitrogen 0.183971577 126.0877778 0.18394077 4 9.11603962
Poly( D, L-lactide-co-alvcolide l 0 121.7619444 0 0
(1) Process Cycle Average= Compound emission quantity/ Total process cycle time in hours.
(2) Compound Emission Average = Compound emission quantity/ Compound emission time in hours.
1/28/2021 Emissions Accountant 8.4.3.08 Emission Master 8.4.3.08 page 1 of 3
Emissions Emissions Emissions
Classification Activities Emitting Uncontrolled (lb) Controlled (lb) Percent Removal
All Emissions 116 28.99119251 28.99119251 0
Acid 0 0 0
Acid Gases 0 0 0
Asbestos 0 0 0
Base 0 0 0
Bioloaical 0 0 0 co 0 0 0
Company List 0 0 0
CR+6 0 0 0
Dioxin 0 0 0
ETG 0 0 0
EVOS 0 0 0
Exclude 0 0 0
Gas 0 0 0
HAP 50 5.768087166 5.768087166 0
Methylene Chloride 50 5.768087166 5.768087166 0
Hydrogen 0 0 0
LOC 0 0 0
Metal 0 0 0
NOx 0 0 0
Other 0 0 0
Particulate 0 0 0
Pb 0 0 0
PM10 0 0 0
PM2.5 0 0 0
Radionuclide 0 0 0
S02 0 0 0
TSP 0 0 0
TVOS 0 0 0
VCM 0 0 0 voe 75 5.798509017 5. 798509017 0
Cyclomethicone 5 53 0.030421851 0.030421851 0
Methylene Chloride 50 5.768087166 5.768087166 0
Unclassified 116 23.19268349 23.19268349 0
Dimethicone 53 0 0
Minocycline Hydrochloride 8 0 0
Minocycline PTS Microsph1 34 0 0
NitroQen 116 23.19268349 23.19268349 0
Poly( D, L-lactide-co-glycolic 44 0 0
Process Cycle Emission Emission Max Rate (lb/hr)
Classification Average (lb/hr) Hours Average (lb/hr) Within 1 hour
All Emissions 0.229967154 126.0877778 0.22992865 12.83103547
Acid 0 0 0 0
Acid Gases 0 0 0 0
Asbestos 0 0 0 0
Base 0 0 0 0
Biolooical 0 0 0 0
1/28/2021 Emissions Accountant 8.4.3.08 Emission Master 8.4.3.08 page 2 of 3
co 0 0 0
Company List 0 0 0
CR+6 0 0 0
Dioxin 0 0 0
ETG 0 0 0
EVOS 0 0 0
Exclude 0 0 0
Gas 0 0 0
HAP 0.045754261 10.06333333 0.573178586
Hydrogen 0 0 0
LOC 0 0 0
Metal 0 0 0
NOx 0 0 0
Other 0 0 0
Particulate 0 0 0
Pb 0 0 0
PM10 0 0 0
PM2.5 0 0 0
Radionuclide 0 0 0
SO2 0 0 0
TSP 0 0 0
TVOS 0 0 0
VCM 0 0 0
voe 0.045995577 125.1597222 0.046328874
Unclassified 0. 183971577 126.0877778 0.183940774
(1) Process Cycle Average= Classification emission quantity/ Total process cycle time in hours.
(2) Emission Average = Classification emission quantity / Classification emission time in hours.
1/28/2021 Emissions Accountant 8.4.3.08 Emission Master 8.4.3.08
0
0
0
0
0
0
0
0
3.714912485
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3.714995849
9.11603962
page 3 of 3
Attachment B
Preliminary 40 CFR Part 63 Subpart VWVW NOCS Table
Alcami Corporation
Morrisville, North Carolina
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocydine PTS Process
Morrisville, NC
Regulatory
§63.11494 What are the applicability requirements and compliance dates?
(a) Except as specified in paragraph (c) of this section, you are subject to this subpart if you own
or operate a chemical manufacturing process unit (CMPU) that meets the conditions specified in
paragraphs (a)(l) and (2) of this section.
{1) The CMPU is located at an area source of hazardous air pollutant (HAP) emissions.
(2) HAP listed in Table 1 to this subpart (Table 1 HAP) are present in the CMPU, as specified in
oara1Zraoh !a){2)(i). liB. (iii). or (iv} of this section.
(i) The CMPU uses as feedstock, any material that contains quinoline, manganese, and/or
trivalent chromium at an individual concentration greater than 1.0 percent by weight, or any
other Table 1 HAP at an individual concentration greater than 0.1 percent by weight. To
determine the Table 1 HAP content of feedstocks, you may rely on formulation data provided by
the manufacturer or supplier, such as the Material Safety Data Sheet (MSDS) for the material. If
the concentration in an MSDS is presented as a range, use the upper bound of the range.
(ii) Quinoline is generated as byproduct and is present in the CMPU in any liquid stream !process
or waste) at a concentration llreater than 1.0 oercent bv wei~ht.
(iii) Hydrazine and/or Table 1 organic HAP other than qui no line are generated as byproduct and
are present in the CMPU in any liquid stream (process or waste}, continuous process vent, or
batch process vent at an individual concentration greater than 0.1 percent by weight.
(iv) Hydrazine or any Table 1 HAP is produced as a product of the CMPU.
(c) This subpart does not apply to the operations specified in paragraphs (c)(l) through (6) of this
section.
Applicability Compliance Comments
Yes No
Regulatory Statement
,v,e,,,y,crn:; c,11onoe 1s lne onry nl'\I' matena1 usea in Ine J'\1cam1
✓
Minocydine PTS manufacturing process at the Alcami RTP, NC
facility. Emissions are less than the 10 tons/yr major source
threshold.
✓ Organic HAP methylene chloride
✓ 100% methylene chloride
✓ Quinoline is not a byproduct of the Alcami Minocycline PTS
nrocess.
Methylene chloride is added to the process vessel with other
✓ constituents resulting in a mix of 15% by weight. Batch process
vessels are vented to atmosphere.
✓ Methylene chloride is not produced
✓ (c)(l) through (6) do not apply to the Alcami Minocycline PTS
orocess.
Page 1 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(d) This subpart applies to each new or existing affected source. The affected source is the facility-
wide collection of CMPUs and each heat exchange system and wastewater system associated
with a CMPU that meets the criteria specified in paragraphs (a) and (b) of this section. A CMPU
using only Table 1 organic HAP is required to control only total CAA section 112(b) organic HAP. A
CMPU using only Table 1 metal HAP is required to control only total CAA section 112(b) metal
HAP in accordance with §63.11495 and, if applicable, §63.11496(().
(1) An affected source is an existing source if you commenced construction or reconstruction of
the affected source before October 6 2008.
(2) An affected source is a new source if you commenced construction or reconstruction of the
affected source on or after October 6 2008.
(e) Any area source that installed a federally-enforceable control device on an affected CMPU is
required to obtain a permit under 40 CFR part 70 or 40 CFR part 71 if the control device on the
affected CMPU is necessary to maintain the source's emissions at area source levels. For new and
existing sources subject to this rule on December 21, 2012 and subject to title Vas a result of this
rule, a complete title V permit application must be submitted no later than December 21, 2013.
New and existing sources that become subject to this rule after December 21, 2012 must submit
a complete title V permit application no later than 12 months after becoming subject to this rule
if the source is subject to title V as a result of this rule. Otherwise, you are exempt from the
obligation to obtain a permit under 40 CFR part 70 or 40 CFR part 71, provided you are not
otherwise required by law to obtain a permit under 40 CFR 70.3(a) or 40 CFR 71.3(a).
Notwithstanding the previous sentence, you must continue to comply with the provisions of this
subpart.
(f) If you own or operate an existing affected source, you must achieve compliance with the
aoolicable orovisions in this suboart no later than March 21 2013.
(g) If you start up a new affected source on or before October 29, 2009, you must achieve
compliance with the applicable provisions of this subpart no later than October 29, 2009.
Applicability Compliance Comments Yes No
The Alcami Minocycline PTS process is the only CMPU at the
✓ facility with no associated heat exchanger or wastewater
system.
✓ Defined as a new source. Not applicable
✓ The Alcami Minocycline PTS process began operation on
IDATEI. Therefore this rule defines the orocess as new.
The Alcami Minocycline PTS process will not have a control
✓ device. The facility will emit less than the major source
thresholds requiring a 40 CFR Part 70 operating permit.
✓ Defined as a new source. Not appliable
✓ Startup commenced after October 29, 2009. Not applicable
Page 2 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocydine PTS Process
Morrisville, NC
Regulatory
(h) If you start up a new affected source after October 29, 2009, you must achieve compliance
with the orovisions in this suboart uoon startuo of vour affected source.
§63.11495 What are the management practices and other requirements?
(a) Management practices. If you have a CMPU subject to this subpart, you must comply with
oara2raohs la)lll throu2h (Sl of this section.
(1) Each process vessel must be equipped with a cover or lid that must be closed at all times
when it is in organic HAP service or metal HAP service, except for manual operations that require
access, such as material addition and removal, inspection, sampling and cleaning. This
requirement does not apply to process vessels containing only metal HAP that are in a liquid
solution or other form that will not result in particulate emissions of metal HAP (e.g., metal HAP
that is in ingot, paste, slurry, or moist pellet form or other form).
(2) You must use any of the methods listed in paragraphs (a)(2)(il through (iv) of this section to
control total organic HAP emissions from transfer of liquids containing Table 1 organic HAP to
tank trucks or railcars. You are not required to comply with this paragraph (a)(2) if you have
notified the Administrator in your initial notification that a material is reactive or resinous, and
you will not be able to comply with any of the methods in paragraphs {a)(2)(i) through (iv) of this
section for the transfer of such material.
(i) Use submerged loading or bottom loading.
(ii) Route emissions to a fuel gas system or process in accordance with §63.982(d) of subpart SS.
(iii) Vapor balance back to the storage tank or another storage tank connected by a common
header.
Applicability Compliance Comments
Yes No
✓ Startup commenced after October 29, 2009. Alcami is in
comoliance with the orovisions uoon startuo.
Regulatory Statement
Compliant: All process equipment and vessels are enclosed or
✓ covered except during brief periods of raw material and waste
container connection.
No initial notification to the Administrator that material used in
the CMPU is reactive or resinous
Compliant: Virgin methylene chloride is delivered to the Alcami
✓ Minocydine PTS process pumped from 55 gallon drums. Waste
is periodically pulled under vacuum from the process back into
empty methylene chloride drums.
✓
✓
Page 3 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(iv) Vent through a closed-vent system to a control device.
(jJ rou must concuct inspections oT process vessels anc equipment ror eacn \..Mt'U m organic
HAP service or metal HAP service, as specified in paragraphs (a)(3)(i) through (v) of this section, to
demonstrate compliance with paragraph (a)(l) of this section and to determine that the process
vessels and equipment are sound and free of leaks. Alternatively, except when the subject CMPU
contains metal HAP as particulate, inspections may be conducted while the subject process
vessels and equipment are in VOC service, provided that teaks can be detected when in VOC
1 ... -.-.:--
(i) Inspections must be conducted at least quarterly.
(ii) For these inspections, detection methods incorporating sight, sound, or smell are acceptable.
Indications of a leak identified using such methods constitute a leak unless you demonstrate that
the indications of a leak are due to a condition other than loss of HAP. If indications of a leak are
determined not to be HAP in one quarterly monitoring period, you must still perform the
inspection and demonstration in the next quarterly monitoring period.
(iii) As an alternative to conducting inspections, as specified in paragraph (a)(3)(ii) of this section,
you may use Method 21 of 40 CFR part 60, appendix A-7, with a leak definition of 500 ppmv to
detect leaks. You may also use Method 21 with a leak definition of 500 ppmv to determine if
indications of a leak identified during an inspection conducted in accordance with paragraph
(a)(3)(ii) of this section are due to a condition other than loss of HAP. The procedures in this
paragraph {a)(3)(iii) may not be used as an alternative to the inspection required by paragraph
(a)(3)(ii) of this section for process vessels that contain metal HAP as particulate.
(ivl Inspections must be conducted while the subject CMPU is operating.
Applicability Compliance Comments
Yes No
✓
Compliant: Alcami has established SOPs to conduct visual
✓ inspections of the process vessels and equipment associated
with the Minocycline PTS process.
✓ Compliant: Inspections are completed at no less than on a
quarterly basis when the process is in service.
✓ Alcami employs sight, sound, and smell in the observation
procedures.
✓ Reference Method 21 procedures not implemented.
✓ Compliant: Alcami performs leak detection while the CMPU is in
ooeration.
Page 4 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocydine PTS Process
Morrisville, NC
Regulatory
(v) No inspection is required in a calendar quarter during which the subject CMPU does not
operate for the entire calendar quarter and is not in organic HAP service or metal HAP service. If
the CMPU operates at all during a calendar quarter, an inspection is required.
(4) You must repair any leak within 15 calendar days after detection of the leak, or document the
reason for any delay of repair. For the purposes of this paragraph (a)(4), a leak will be considered
"repaired" if a condition specified in paragraph (a)(4)(i), (ii), or (iii) of this section is met.
(i) The visual, audible, olfactory, or other indications of a leak to the atmosphere have been
eliminated, or
(ii) No bubbles are observed at potential leak sites during a leak check using soap solution, or
(iii) The system will hold a test pressure.
(5) You must keep records of the dates and results of each inspection event, the dates of
equipment repairs, and, if applicable, the reasons for any delay in repair.
\O) Small heat exchange systems. For each heat exchange system subject to this subpart with a
cooling water flow rate less than 8,000 gallons per minute (gal/min) and not meeting one or
more of the conditions in §63.104(a), you must comply with paragraphs (b)(l) through (3) of this
section, or as an alternative, you may comply with any one of the requirements in Item 1.a or 1.b
,..f T:,1-.IA ~ tn +h;, <o ,hn"lrt
Applicability Compliance Comments Yes No
✓ Compliant: Alcami conducts inspection during operation of the
A1cami Minocycline PTS process.
Compliant: Alcami has established a work practice system to ✓ detect and repair any leaks consistent with these requirements.
✓ Compliant: Alcami has established a work practice system to
detect and repair any leaks consistent with these requirements.
✓ Compliant: Alea mi has established a work practice system to
detect and repair any leaks consistent with these requirements.
✓ Compliant: Alcami has established a work practice system to
detect and repair any leaks consistent with these requirements.
✓ Compliant: Alcami has established a work practice system to
detect and repair any leaks consistent with these requirements.
✓ The Alcami Minocycline PTS process does not have a heat
exchanger.
Page S of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
1.11 rnu must develop and operate m accordance wn:n a neat excnange system mspecuon plan.
The plan must describe the inspections to be performed that will provide evidence of
hydrocarbons in the cooling water. Among other things, inspections may include checks for
visible floating hydrocarbon on the water, hydrocarbon odor, discolored water, and/or chemical
addition rates. You must conduct inspections at least once per quarter, even if the previous
inspection determined that the indications of a leak did not constitute a leak as defined by
I~.:;~ 1 n.dlh\/,:;\
(2} You must perform repairs to eliminate the leak and any indications of a leak or demonstrate
that the HAP concentration in the cooling water does not constitute a leak, as defined by
§63.104(b}(6), within 45 calendar days after indications of the leak are identified, or you must
document the reason for any delay of repair in your next semiannual compliance report.
(3) You must keep records of the dates and results of each inspection, documentation of any
demonstrations that indications of a leak do not constitute a leak, the dates of leak repairs, and,
if annlicable the reasons for anv delav in renair.
(c) Startup, shutdown and malfunction. Startup, shutdown, and malfunction (SSM) provisions in
subparts that are referenced in paragraphs (a) and (b) of this section do not apply.
(d) General duty. At all times, you must operate and maintain any affected CMPU, including
associated air pollution control equipment and monitoring equipment, in a manner consistent
with safety and good air pollution control practices for minimizing emissions. Determination of
whether such operation and maintenance procedures are being used will be based on
information available to the Administrator, which may include, but is not limited to, monitoring
results, review of operation and maintenance procedures, review of operation and maintenance
records, and inspection of the CMPU.
§63.11496 What are the standards and compliance requirements for process vents?
Applicability Compliance Comments Yes No
✓ The Alcami Minocycline PTS process does not have a heat
exchanger.
✓ The Alcami Minocycline PTS process does not have a heat
exchanger.
✓ The Alcami Minocycline PTS process does not have a heat
exchanger.
Regulatory Statement
✓ Compliant: Alea mi operates the Minocycline PTS process per
safety and good air pollution control practices.
Page 6 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation• Minocycline PTS Process
Morrisville, NC
Regulatory
,aJ urgamc HAI' emissions from batch process vents. You must comp1y witn tne requirements in
paragraphs (a)(l) through (4) of this section for organic HAP emissions from your batch process
vents for each CMPU using Table 1 organic HAP. If uncontrolled organic HAP emissions from all
batch process vents from a CMPU subject to this subpart are equal to or greater than 10,000
pounds per year (lb/yr), you must also comply with the emission limits and other requirements in
IT::lhl-') •-+1,,.;r c11h--.r-t
(1) You must determine the sum of actual organic HAP emissions from all of your batch process
vents within a CMPU subject to this subpart using process knowledge, engineering assessment, or
test data. Emissions for a standard batch in a process may be used to represent actual emissions
from each batch in that process. You must maintain records of the calculations. Calculations of
annual emissions are not required if you meet the emission standards for batch process vents in
Table 2 to this subpart.
(2) As an alternative to calculating actual emissions for each affected CMPU at your facility, you
may elect to estimate emissions for each CMPU based on the emissions for the worst-case CMPU.
The worst-case CMPU means the CMPU at the affected source with the highest organic HAP
emissions per batch. The worst-case emissions per batch are used with the number of batches
run for other affected CMPU. Process knowledge, engineering assessment, or test data may be
used to identify the worst-case process. You must keep records of the information and
procedures used to identify the worst-case process.
(3) If your current estimate is that emissions from batch process vents from a CMPU are less than
10,000 pounds per year (lb/yr), then you must keep a record of the number of batches of each
process operated per month. Also, you must reevaluate your total emissions from batch process
vents prior to making any process changes that affect emission calculations in paragraphs (a)(l)
and (2} of this section. If projected emissions increase to 10,000 lb/yr or more, you must be in
compliance options for batch process vents in Table 2 to this subpart upon initiating operation
under the new operating conditions. You must maintain records documenting the results of all
updated emissions calculations.
Applicability Compliance Comments Yes No
Compliant: Based on emission modeling calculations, the Alcami
✓ Minocycline PTS process emits 5.77 lb/batch of MeCI. Annual
emissions of MeCI are well below 10,000 lb/yr.
Compliant: Alcami has determined the sum of actual HAP
✓ emissions from each batch process vent per emissions modeling
formulations (engineering assessment). Records of the
calculations are maintained.
✓ The Alcami Minocycline PTS process is the only CMPU at Alcami.
Compliant: Calculated emissions are less than 10,000 lb/yr.
✓ Alcami maintains monthly batch records. No process changes
are anticipated.
Page 7 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(4) As an alternative to determining the HAP emissions, you may elect to demonstrate that the
amount of organic HAP used in the process is less than 10,000 lb/yr. You must keep monthly
records of the organic HAP usage.
(b) Organic HAP emissions from continuous process vents. You must comply with the
requirements in paragraphs (b)(l) through (3) of this section for organic HAP emissions from your
continuous process vents for each CMPU subject to this subpart using Table 1 organic HAP. If the
total resource-effectiveness (TRE) index value for a continuous process vent is less than or equal
to 1.0, you must also comply with the emission limits and other requirements in Table 3 to this
subpart.
(b)(l) through (3)
(c) Combined streams. If you combine organic HAP emissions from batch process vents and
continuous process vents, you must comply with the more stringent standard in Table 2 or Table
3 to this subpart that applies to any portion of the combined stream, or you must comply with
Table 2 for the batch process vents and Table 3 for the continuous process vents. The TRE index
value for continuous process vents and the annual emissions from batch process vents shall be
determined for the individual streams before they are combined, and prior to any control (e.g.,
by subtracting any emission contributions from storage tanks, continuous process vents or batch
process vents, as applicable), in order to determine the most stringent applicable requirements.
(d) Halogenated streams. You must determine if an emission stream is a halogenated vent stream
by calculating the mass emission rate of halogen atoms in accordance with §63.115(d)(2)(v).
Alternatively, you may elect to designate the emission stream as halogenated. If you use a
combustion device to comply with the emission limits for organic HAP from a halogenated batch
process vent or a halogenated continuous process vent, you must use a halogen reduction device
to meet the emission limit in either paragraph (d)(l) or (d)(2) of this section and in accordance
with §63.994 and the requirements referenced therein.
Applicability Compliance Comments Yes No
✓ Compliant: Current process volumes use less than 10,000 lb/yr
of organic HAP.
✓ The Alcami Minocycline PTS process is a batch process.
✓ The Alcami Minocycline PTS process is a batch process.
✓ Table 2 for combined batch process vents not available in the
published Rule (FR Vol. 77, No. 246)
Compliant: Emission stream is halogenated (methylene
✓ chloride). Emission rate calculated in accordance with
§63.115(d)(2)(v).
Page 8 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(1) Reduce overall emissions of hydrogen halide and halogen HAP after the combustion device by
greater than or equal to 95 percent, to less than or equal to 0.45 kilograms per hour (kg/hr), or to
a concentration less than or equal to 20 parts per million by volume (ppmv).
(2) Reduce the halogen atom mass emission rate before the combustion device to less than or
eaua1 to 0.45 kiz/hr or to a concentration less than or eaual to 20 oomv.
(e) Alternative standard for organic HAP. Exceptions to the requirements for the alternative
standard requirements specified in Tables 2 and 3 to this subpart and §63.2505 are specified in
oarallraohs leHll throueh 161 of this section.
(1) When §63.2505 of subpart FFFF refers to Tables 1 and 2 to subpart FFFF and §§63.2455 and
63.2460, it means Tables 2 and 3 to this subpart and §63.11496{a) and (b).
(f} Emissions from metal HAP process vents.
(g) Exceptions and alternatives to 40 CFR part 63, subpart SS.
(h) Surge control vessels and bottoms receivers. For each surge control vessel and bottoms
receiver that meets the applicability criteria for storage tanks specified in Table 5 to this subpart,
you must meet the emission limits and control requirements specified in Table 5 to this subpart.
(i) Startup, shutdown, and malfunction (SSM}. References to SSM provisions in subparts that are
referenced in paragraphs (a} through (h} of this section or Tables 2 through 5 to this subpart do
not annlv.
§63.11497 What are the standards and compliance requirements for storage tanks?
(a) You must comply with the emission limits and other requirements in Table 5 to this subpart
and in paragraph (bl of this section for organic HAP emissions from each of your storage tanks
that meet the annlicabilitv criteria in Table S to this suboart.
(b) Planned routine maintenance for a control device. Operate in accordance with paragraphs
(b)(l) through (3) of this section for periods of planned routine maintenance of a control device
for storai:re tanks.
Applicability Compliance Comments
Yes No
✓ Emissions uncontrolled.
✓ Emissions uncontrolled
✓ Alcami is not electing an alternative standard
✓ Alcami is not electing an alternative standard
✓ The Alcami Minocycline PTS process does not emit metal HAP.
✓ Process not vented to a fuel gas system.
Alcami Minocycline PTS process is a batch process. Additionally, ✓ all process storage vessels are well below 10,000 gallons.
Regulatory Statement
✓ All process storage vessels are well below 10,000 gallons.
✓ No storage tanks nor control devices.
Page 9 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory Applicability
Yes No
(d) Combustion of halogenated streams. If you use a combustion device to comply with the
emission limits for organic HAP from a halogenated vent stream from a storage tank, you must ✓
reduce emissions in accordance with §63.11496(d) and the requirements referenced therein.
§63.11498 What are the standards and compliance requirements for wastewater systems?
(a) You must comply with the requirements in paragraph (a)(1) and (2) of this section and in Table
6, Item 1 to this subpart for all wastewater streams from a CMPU subject to this subpart. If the
partially soluble HAP concentration in a wastewater stream is equal to or greater than 10,000 ✓
parts per million by weight (ppmw) and the wastewater stream contains a separate organic
phase, then you must also comply with Table 6, Item 2 to this subpart for that wastewater
stream. Partially soluble HAP are listed in Table 7 to this subpart.
§63.11499 What are the standards and compliance requirements for heat exchange systems?
(a) If the cooling water flow rate in your heat exchange system is equal to or greater than 8,000
gal/min and is not meeting one or more of the conditions in §63.104(a), then you must comply ✓
with one of the renuirements snecified in Table 8 to this suboart.
Compliance Comments
No halogenated stream combustion devices.
-
Alcami Minocycline PTS process Is not tied to a wastewater
system.
Alcami Minocycline PTS process does not have a heat exchange
system.
§63.11500 What compliance options do I have if part of my plant is subject to both this subpart and another Federal standard?
Page 10 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alea mi Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
For any CMPU, heat exchange system, or wastewater system subject to the provisions of both
this subpart and another rule, you may elect to comply only with the more stringent provisions as
specified in paragraphs (a) through (d) of this section. You must consider all provisions of the
rules, including monitoring, recordkeeping, and reporting. You must identify the subject CMPU,
heat exchange system, and/or wastewater system, and the provisions with which you will comply
in your NOCS report required by §63.llS0l(b). You also must demonstrate in your NOCS report
that each provision with which you will comply is at least as stringent as the otherwise applicable
requirement in this subpart WVWV. You are responsible for making accurate determinations
concerning the more stringent standards and noncompliance with this rule is not excused if it is
later determined that your determination was in error and, as a result, you are violating this
subpart. Compliance with this rule is your responsibility and the NOCS report does not alter or
affect that responsibility.
1aJ Compliance with other subparts of this part 63. (1) It any part or a CMPU tnat as subJect to the
provisions of this subpart is also subject to the provisions of another subpart of 40 CFR part 63,
then compliance with any of the requirements in the other subpart of this part 63 that are at
least as stringent as the corresponding requirements in this subpart WWW constitutes
----"--,-., with thi<:. ~ .. h ... .,.rt ·,ruv-.ivv
(2) After the compliance dates specified in §63.11494, at an offsite reloading or cleaning facility
subject to §63.1253(f), as referenced from §63.2470(e) and Table 4 to subpart WWW,
compliance with the monitoring, recordkeeping, and reporting provisions of any other subpart of
this part 63 constitutes compliance with the monitoring, recordkeeping, and reporting provisions
of §63.1253(f)P)(ii) or (iii). You must identify in your notification of compliance status report
required by §63.llS0l(b) the subpart of this part 63 with which the owner or operator of the
offsite reloading or cleaning facility complies.
Applicability Compliance Comments Yes No
✓ Alcami Minocycline PTS process does not have a heat exchange
system and is not tied to a wastewater system.
✓ No other Part 63 applicability.
✓ Alcami does not use an offsite reloading or cleaning facility.
Page 11 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(b} Compliance with subparts of 40 CFR part 60. If any part of a CMPU that is subject to the
provisions of this subpart is also subject to the provisions of subpart W, DDD, Ill, NNN, RRR, or
YYY in 40 CFR part 60, then compliance with any of the requirements in 40 CFR part 60, subpart
W, DDD, Ill, NNN, RRR, or YYY that are at least as stringent as the corresponding requirements in
this subpart WWW constitutes compliance with this subpart WWW.
,Cl Compliance with subparts of 40 CFR part 61. If any part of a CMPU that 1s subject to the
provisions of this subpart is also subject to the provisions of subpart V, Y, BB, or FF of 40 CFR part
61, then compliance with any of the requirements in 40 CFR part 61, subpart V, Y, BB, or FF that
are at least as stringent as the corresponding requirements in this subpart WWW constitutes
,,.,.,m,..1;.,.,..,..,. with thi<: ,., ,hn,,,rt '.,Av -r,,.,
Applicability Compliance Comments
Yes No
✓ Alcami is not a Synthetic Organic Chemical or Polymers
manufacturer.
✓ Part 61 NESHAPs do not apply to Alcami.
§63.11501 What are the notification, recordkeeping, and reporting requirements, and how may I assert an affirmative defense for violation of emission
standards during malfunction?
'\0/ ...,._,.,_:101 y1vv1:,,.,.i;>. 1uu 11,u~• 111,:1:a .,,., 1,::~u11c ,.,.,,-:, u1 u1,:: ~~.,~,o, r•v••~•ull;> 111 Tv -• fidr.
63, subpart A, as shown in Table 9 to this subpart. The General Provisions in other parts do not
apply except when a requirement in an overlapping standard, which you determined is at least as ✓ Compliant with the General Provisions of 40 CFR Part 63,
stringent as subpart WWW and with which you have opted to comply, requires compliance Subpart A
with general provisions in another part.
(b) Notification of compliance status (NOCS). Your NOCS required by §63.9(h) must include the ✓ Compliant: Alcami is providing a Subpart WWW NOCS.
followin~ additional information as annlicable:
(1) This certification of compliance, signed by a responsible official: ✓ Compliant: Signed Truth & Accuracy Statement provided
(i) "This facility complies with the management practices in §63.11495." ✓ Compliant: Included in Truth & Accuracy Statement
,ii} 'This facility complies with the requirements in §63.11496 for HAP emissions from process ✓ Compliant: Included in Truth & Accuracy Statement
vents."
iii) 'This facility complies with the requirements in §63.11496 and §63.11497 for surge control ✓ Compliant: Included in Truth & Accuracy Statement vessels, bottoms receivers, and storage tanks."
✓ Compliant: Included in Truth & Accuracy Statement, however,
(iv} ''This facility complies with the requirements in §63.11498 to treat wastewater streams." not aoolicable.
Page 12 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(v) "This facility complies with the requirements in §63.11499 for heat exchange systems."
(2) If you comply with the alternative standard as specified in Table 2 to this subpart or Table 3 to
this subpart, include the information specified in §63.1258(b)(S), as applicable.
{jJ It you estaousn an operating 11m1t for a parameter ,nat w111 not oe momtoreo continuously in
accordance with §§63.11496(g)(4) and 63.24S0(k)(6), provide the information as specified in
§§63.11496(g)(4) and 63.2450(k)(6).
(4) A list of all transferred liquids that are reactive or resinous materials, as defined in
§63.11502(b).
(5) If you comply with provisions in an overlapping rule in accordance with §63.11500, identify
the affected CMPU, heat exchange system, and/or wastewater system; provide a list of the
specific provisions with which you will comply; and demonstrate that the provisions with which
you will comply are at least as stringent as the otherwise applicable requirements, including
monitoring, recordkeeping, and reporting requirements, in this subpart WWW.
(c) Recordkeeping. You must maintain files of all information required by this subpart for at least
5 years following the date of each occurrence according to the requirements in §63.l0(b)
,1). It you are sulJJect, you must comply witn tne recoraKeepmg ana reporung requirements ot
§63.10(b)(2)(iii) and (vi) through (xiv), and the applicable requirements specified in paragraphs
(c)(l) through (8) of this section.
,1) For each CMPU subject to this subpart, you must keep the records specified in paragraphs
(c)(l)(i) through (viii) of this section.
til Records of management practice inspections, repairs, and reasons for any delay of repair, as
specified in §63.1149S(a)(S).
11) Recoras ot small neat excnange system inspections, aemonstrat1ons ot mo1cat1ons or 1ea1<s
that do not constitute leaks, repairs, and reasons for any delay in repair as specified in
§63.1149S(b).
Applicability Compliance Comments Yes No
✓ Compliant: Included in Truth & Accuracy Statement, however,
not aoolicable.
✓ Not applicable.
✓ Not applicable batch process vents.
✓ Not applicable.
✓ Not applicable.
✓ Compliant: 5-year records maintained.
✓ Not applicable.
✓ Compliant: As stated below.
✓ Compliant: Records maintained.
✓ Not applicable. No small heat exchangers.
Page 13 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(iii) If batch process vent emissions are less than 10,000 lb/yr for a CMPU, records of batch
process vent emission calculations, as specified in §63.11496(a)(l), the number of batches
operated each month, as specified in §63.11496(a)(3), and any updated emissions calculations, as
specified in §63.11496(a)(3). Alternatively, keep records of the worst-case processes or organic
HAP usage, as specified in §63.11496(a)(2) and (4), respectively.
(iv) Records of all TRE calculations for continuous process vents as specified in §63.11496(b)(2).
1v1 ""'cores u, mei:a1 n,.,. t:1111ss1on caTcu--ra-rron---s-as s..,., .. m.,u in yoJ.J.J.~~O\TJ\.L.I ,mu 1"-1· n tOlo•
uncontrolled metal HAP process vent emissions from a CMPU subject to this subpart are
estimated to be less than 400 lb/yr, also keep records of either the number of batches per month
or operating hours, as specified in §63.11496(f)(2).
,vi) Records identifying wastewater streams and the type ot treatment they receive, as specified
in Table 6 to this subpart.
(vii) Records of the date, time, and duration of each malfunction of operation of process
equipment, control devices, recovery devices, or continuous monitoring systems used to comply
with this subpart that causes a failure to meet a standard. The record must include a list of the
affected sources or equipment, an estimate of the volume of each regulated pollutant emitted
over the standard, and a description of the method used to estimate the emissions.
{viii) Records of actions taken during periods of malfunction to minimize emissions in accordance
with §63.11495(d), including corrective actions to restore malfunctioning process and air
pollution control and monitoring equipment to its normal or usual manner of operation.
(2) For batch process vents subject to Table 2 to this subpart and continuous process vents
subject to Table 3 to this subpart, you must keep records specified in paragraphs (c)(2)(i) or (ii) of
this section as annlicable.
Applicability Compliance Comments Yes No
✓ Compliant: Records of worst-case organic HAP usage
maintained.
✓ Alcami Minocycline PTS is a batch process.
✓ No metal HAP usage or emissions.
✓ No wastewater system ties to the Alcami CMPU.
✓ Compliant: Preventative maintenance and repair records
maintained.
✓ Compliant: Preventative maintenance and repair records
maintained.
✓ Compliant: As stated below.
Page 14 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alcami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(i) If you route emissions to a control device other than a flare, keep records of performance
tests, if applicable, as specified in §63.998(a){2)(ii) and (4), keep records of the monitoring system
and the monitored parameters, as specified in §63.998(b) and (c), and keep records of the closed-
vent system, as specified in §63.998(d)(1). If you use a recovery device to maintain the TRE above
1.0 for a continuous process vent, keep records of monitoring parameters during the TRE index
value determination, as specified in §63.998(a)(3).
(ii) If you route emissions to a flare, keep records of the flare compliance assessment, as specified
in §63.998(a)(l)(i), keep records of the pilot flame monitoring, as specified in §63.998(a)(l){ii)
and (iii), and keep records of the closed-vent system, as specified in §63.998(d)(l).
{3) For metal HAP process vents subject to Table 4 to this subpart, you must keep records
soecified in oarae:raohs (d{3ltil or fiil of this section as annlicable.
(4) For each storage tank subject to Table 5 to this subpart, you must keep records specified in
1oara1?raohs {d(4l(i) throul?h lvil of this section as annlicable.
(5) For each wastewater stream subject to Item 2 in Table 6 to this subpart, keep records of the
wastewater stream identification and the disposition of the organic phase(s), as specified in Item
2 to Table 6 to this suboart.
(6) For each large heat exchange system subject to Table 8 to this subpart, you must keep records
of detected leaks; the date the leak was detected; if demonstrated not to be a leak, the basis for
that determination; the date of efforts to repair the leak; and the date the leak is repaired, as
cnorifjoti in T.abl~ 8 tn thic; c1Jbo.art.
(7) You must keep a record of all transferred liquids that are reactive or resinous materials, as
defined in §63.11502{bl and not included in the NOCS.
(8) For continuous process vents subject to Table 3 to this subpart, keep records of the
occurrence and duration of each startup and shutdown of operation of process equipment, or of
air oollution control and monitorine: eauioment.
Applicability Compliance Comments Yes No
✓ No control device.
✓ No flare.
✓ No metal HAP usage or emissions.
✓ No process storage tanks 10,000 gallons or larger.
✓ Process does not have a wastewater stream
✓ The A1cami Minocycline PTS process does not have a heat
exchanger.
✓ The Alcami Minocycline PTS process does not use reactive or
resinous materials as defined bv §63.11502(bl.
✓ The Alcami Minocycline PTS process vents are batch only.
Page 15 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Alea mi Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
(d) Semiannual Compliance Reports. You must submit semiannual compliance reports that
contain the information specified in paragraphs (d)(l) through (7) of this section, as applicable.
Reports are required only for semiannual periods during which you experienced any of the events
,i.,..,rrihoti in n:>r:>or:>nhs fdll1 l thrn11ah t~I nf thic ,;1>ctian.
(1) Deviations. You must clearly identify any deviation from the requirements of this subpart.
(2) Delay of repair for a large heat exchange system. You must include the information specified
in §63.104(f)(2} each time you invoke the delay of repair provisions for a heat exchange system
with a coo lino water flow rate enual to or 11reater than 8 000 izal/min.
(3) Delay of leak repair. You must provide the following information for each delay of leak repair
beyond 15 days for any process equipment, storage tank, surge control vessel, bottoms receiver,
and each delay of leak repair beyond 45 days for any heat exchange system with a cooling water
flow rate less than 8,000 gal/min: information on the date the leak was identified, the reason for
the delay in repair, and the date the leak was repaired.
(4) Process change. You must report each process change that affects a compliance
determination and submit a new certification of compliance with the applicable requirements in
accordance with the procedures specified in paragraph (b) of this section.
(5) Data for the alternative standard. If you comply with the alternative standard, as specified in
Table 2 to this subpart or Table 3 to this subpart, report the information required in
§63.1258/bllSl.
(6) Overlapping rule requirements. Report any changes in the overlapping provisions with which
vou comolv.
(7) Reactive and resinous materials. Report any transfer of liquids that are reactive or resinous
materials as defined in §63.11502/bl. and not included in the NOCS.
Applicability compliance Comments Yes No
✓ Compliant: No semiannual compliance report required as
indicated below.
✓ Compliant: No deviations to report.
✓ The Alcami Minocycline PTS process does not have a heat
exchanger.
✓ Compliant: No leak repairs to report.
✓ Compliant: No process changes affecting compliance to report.
✓ Alcami is not requesting an alternative standard.
✓ No overlapping rule requirements.
✓ The Alcami Minocycline PTS process does not use reactive or
resinous materials as defined bv §63.115021bl.
Page 16 of 17
DRAFT Notice of Compliance Status
40 CFR Part 63 National Emission Standards for Hazardous Air Pollutants for
Chemical
Manufacturing Area Sources
Akami Corporation -Minocycline PTS Process
Morrisville, NC
Regulatory
1o1 Ma1runcuons. 1r a manunct1on occurreo curing me repomng perioo, me reporc must 1nc1uoe
the number of instances of malfunctions that caused emissions in excess of a standard. For each
malfunction that caused emissions in excess of a standard, the report must include a list of the
affected sources or equipment, an estimate of the volume of each regulated pollutant emitted
over the standard, and a description of the method used to estimate the emissions. The report
must also include a description of actions you took during a malfunction of an affected source to
minimize emissions in accordance with §63.11495(d), including actions taken to correct a
,_",,. ~· -
(el Affirmative defense for violation of emission standards during malfunction. In response to an
action to enforce the standards set forth in §§63.11495 through 63.11499, you may assert an
affirmative defense to a claim for civil penalties for violations of such standards that are caused
by malfunction, as defined at 40 CFR 63.2. Appropriate penalties may be assessed if you fail to
meet your burden of proving all of the requirements in the affirmative defense. The affirmative
defense shall not available for claims for injunctive relief.
(1) To establish the affirmative defense in any action to enforce such a standard, you must timely
meet the notification requirements in paragraph (e)(2) of this section, and must prove by a
oreoonderance of evidence that:
(2) Report. If you seek to assert an affirmative defense, you must submit a written report to the
Administrator, with alt necessary supporting documentation, that you have met the requirements
set forth in paragraph (e)(l) of this section. This affirmative defense report must be included in
the first periodic compliance report, deviation report, or excess emission report otherwise
required after the initial occurrence of the violation of the relevant standard (which may be the
end of any applicable averaging period}. If such compliance report, deviation report, or excess
emission report is due less than 45 days after the initial occurrence of the violation, the
affirmative defense report may be included in the second compliance report, deviation report, or
excess emission report due after the initial occurrence of the violation of the relevant standard.
Applicability Compliance Comments Yes No
✓ Compliant: No malfunctions to report.
✓
✓
✓
Page 17 of 17
Attachment C
300 kW Natural Gas-Fired Engine Specs
Alcami Corporation
Morrisville, North Carolina
PRODUCT SPECIFICATIONS FOR DG300 GC (3 PHASE)
GENERATOR SET SPECIFICATIONS
Frequency
Natural Gas Rating
Emissions/Fuel Strategy
Displacement
Speed
ENGINE SPECIFICATIONS
Engine Model
Compression Ratio
Fuel System
Bore
Stroke
GENERATOR SET DIMENSIONS
Length
Width
Height
Weight
60 Hz
300 eKW
U.S. EPA Certified for Stationary Emergency
Application
864.71 ln3
1800 rpm
14.2 L Spark. Ignited
9.5:1
Electronic
5.31 in
6.5 in
136 in
57.6 in
66.1 in
6274Ib
DG300 GC (3 PHASE) STANDARD EQUIPMENT
COOLI NG
Closed coolant recovery system
50/50 Ethylene glycol antifreeze
Factory-installed radiator
Standard ambient temperatures up to 50°C (122°F)
Radiator and cooling fan complete with protective guards
AIR INLET
Single element air filter
FUEL
Low fuel pressure switch
Primary and secondary fuel shut-off
Fuel pressure test po
Dual locK off valves
Natural Gas or LP Vapor
NPT connection
EXHAUST
Exhaust outlet with 3" pipe
GENERATOR
Full load capacity alternator
Class H insulation material
Permanent magnet excitation
Matched to the performance and output characteristics of Cat engines
Class H insulation material
Integrated Voltage Regulator
Permanent magnet excitation
I P23 Protection
Full load capacity alternator
CONTROLS
EMCP 4.2 Series generator set controller
MOUNTING
Vibration isolaton (puck type)
Rubber vibration isolators
ELECTRIC STARTING AND/OR PRELUBE
Engine electrical system
Battery cables
Solenoid activated starter motor
Solenoid activated starter motor
ELECTRIC POWER -PACKAGE SERIAL NUMBER PREFIX
Battery charging alternator
GOVERNOR
Electronic governor (non adjustable)
CONTROL PANEL
EMCP 4.2 Series generator set controller
STARTING/CHARGING
Batteries with rack and cables
12 volt starting motor
DG300 GC (3 PHASE) OPTIONAL EQUIPMENT
STARTING/CHARGING
Charging alternator
Battery charger -UL Listed 10 amp
Jacket water heater
Battery heater
GENERAL
Suitable for Use as Service Equipment (SUSE)
UL 2200 package
Automatic transfer switches (ATS)
Enclosures: sound attenuated, weather protective
CSA Certification
GENERATOR
Anti-condensation heater
Shunt trip and auxiliary contact breaker
Thermal magnetic or electronic trip MCCBs
Oversize and premium generators
Excitation: ( )Permanent Magnet Excited (PM}
Anti-condensation heater