Draft Permit Review
Region: Raleigh Regional Office County: Wake NC Facility ID: 9200349 Inspector’s Name: Gary Perlmutter Date of Last Inspection: 02/05/2016 Compliance Code: 3 / Compliance - inspection Permit Applicability (this application only)
NORTH CAROLINA DIVISION OF AIR QUALITY
Air Permit Review Permit Issue Date: Facility Data Applicant (Facility’s Name): Mallinckrodt - Raleigh Pharmaceutical Plant
SIP: 02D .1111 NSPS: NESHAP: MACT Subpart EEE PSD: PSD Avoidance: NC Toxics: 112(r): Other:
Facility Address: Mallinckrodt - Raleigh Pharmaceutical Plant 8801 Capital Boulevard Raleigh, NC 27616 SIC: 2833 / Medicinals And Botanicals NAICS: 325411 / Medicinal and Botanical Manufacturing Facility Classification: Before: Title V After: Title V Fee Classification: Before: Title V After: Title V Contact Data Facility Contact Timothy Roberts Environmental Manager (919) 878-2895 8801 Capital Boulevard Raleigh, NC 27616
Authorized Contact Timothy Goodman Site Director (919) 878-2822 8801 Capital Boulevard Raleigh, NC 27616
Application Data Technical Contact
Application Number: 9200349.16A Date Received: 07/07/2016 Application Type: Modification Application Schedule: TV-Sign-501(c)(2) Part II Existing Permit Data Existing Permit Number: 01479/T55 Existing Permit Issue Date: 04/21/2016 Existing Permit Expiration Date: 09/30/2020
Graham Gibson Sr. Environmental Engineer, EHS (919) 878-2885 8801 Capital Boulevard Raleigh, NC 27616
Total Actual emissions in TONS/YEAR: CY
SO2
NOX
VOC
CO
PM10
Total HAP
Largest HAP
2014
17.74
51.51
19.29
32.03
9.34
8.69
4.14 [Aniline]
2013
8.18
49.52
18.02
34.75
10.75
8.82
4.07 [Aniline]
2012
8.65
46.99
19.02
35.09
10.05
9.30
4.18 [Nitrobenzene]
2011
8.83
46.20
20.07
36.84
10.34
9.58
4.73 [Nitrobenzene]
2010
35.53
36.90
16.92
34.48
9.52
7.87
3.17 [Aniline]
Review Engineer: Russell Braswell Review Engineer’s Signature:
Date:
Comments / Recommendations: Issue 01479/T56 Permit Issue Date: Permit Expiration Date:
Review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant Page 2 of 3
1. Purpose of Application: Mallinckrodt - Raleigh Pharmaceutical Plant (Mallinckrodt) was issued Air Quality Permit 01479T53 on July 7, 2015. This permit action changed compliance options for boiler BH-7 under MACT Subpart EEE. The permit application was processed as the first step of a 2-step significant modification (see 02Q .0501(c)(2)). 02Q .0501(c)(2) requires that a second permit application be submitted within 12 months of the first step being implemented. Between the issuance of T43 and the current date, two other permits were issued to Mallinckrodt. Neither of these permit actions dealt with the 02Q .0501(c)(2) requirement. Therefore, Mallinckrodt has submitted this permit application. 2. Facility Description: "Mallinckrodt is a facility that primarily manufactures acetaminophen, an analgesic found in pain and cold medications. Currently, this facility manufactures the majority of the U.S. supply of acetaminophen. In the PAP and APAP plants, a range of raw chemical by-products are also produced, including aniline, acetic acid, ammonium sulfate (for fertilizer), and KO83 tar (which is used for fuel in two boilers)."1 3. Application Chronology:
July 7, 2016
Application received.
August 18, 2016
An initial draft of the permit and review were sent to DAQ staff (Tom Anderson, Mark Cuilla, Samir Parekh, Will Wike, Charles McEachern) and Mallinkrodt staff (Graham Gibson). For a summary of comments received, see Attachment 3.
XXXX
Public / EPA notice
XXXX
Permit issued.
4. Permit Modifications and Regulatory Review: The boiler BH-7 is subject to 40 CFR Part 63 Subpart EEE "National Emission Standards for Hazardous Air Pollutants from Hazardous Waste Combustors" (referred to as "Subpart EEE"). This rule contains emission standards for several pollutants and requires an initial compliance demonstration for each pollutant. 40 CFR 63.1217(f) allows subject facilities to comply with the emission standards in 40 CFR 266.105 and .106 in lieu of Subpart EEE for the following pollutants: PM, chromium, cadmium, and lead. As a result of emission testing, Mallinckrodt has elected to use this option. In the T53 permit (Betty Gatano, July 7, 2015), Mallinckrodt was allowed to demonstrate compliance using the option under 63.1217(f) or the emission limits in Subpart EEE. See Attachment 2 for the permit review associated with T53. Mallinckrodt performed the compliance demonstrations between October and December 2013, and then re-tested during February 2015. Based on these test results and discussions with NC Division of Waste 1
From Will Wike's inspection report dated July 30, 2015.
Review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant Page 3 of 3
Management, Mallinckrodt has ultimately decided to rely on the compliance option in 40 CFR 63.1217(f). The permit condition for Subpart EEE has been updated to reflect the parameters used during the emission testing and Mallinckrodt's election to comply under 40 CFR 266.105 and .106. Note that compliance under 40 CFR 266.105 and .106 is determined by the NC Division of Waste Management, not Air Quality. 5. Public Notice/EPA and Affected State(s) Review A notice of the DRAFT Title V Permit shall be made pursuant to 15A NCAC 2Q .0521. The notice will provide for a 30-day comment period, with an opportunity for a public hearing. Copies of the public notice shall be sent to persons on the Title V mailing list and EPA. Pursuant to 15A NCAC 2Q .0522, a copy of each permit application, each proposed permit and each final permit pursuant shall be provided to EPA. Also pursuant to 2Q .0522, a notice of the DRAFT Title V Permit shall be provided to each affected State at or before the time notice provided to the public under 2Q .0521 above. 6. Recommendations Issue permit 01479T56.
Attachment 1 to review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant
Change List Pages Throughout
Section Throughout 2.1.D.5.
Description of Changes Updated dates, permit, and application numbers Updated section to reflect recent testing results and compliance with 40 CFR 266.105 and .106.
Attachment 2 to review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant Page 1 of 14
T53 Permit Review (Betty Gatano, July 7, 2015)
1. Purpose of Application Mallinckrodt - Raleigh Pharmaceutical Plant (Mallinckrodt) currently holds Title V Permit No. 01479T52 with an expiration date of February 28, 2015 for a pharmaceutical manufacturing facility in Raleigh, Wake County, North Carolina. A permit application for a significant modification under 15A NCAC 2Q .0501(c)(2) was received on May 11, 2015. In the permit application, the facility proposed removing emission limits for boiler (ID No. BH-7) for cadmium and lead, chromium, and particulate matter (PM) under the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE, and complying instead with the Resource and Recovery Act (RCRA) Part B permit for these pollutants. This compliance option is allowed pursuant to 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3). Because the permit application was submitted as a significant modification under 15A NCAC 2Q .0501(c)(2), the emission limits for cadmium and lead, chromium, and PM under MACT Subpart EEE cannot be removed under this permit process/schedule. Instead, both compliance options for these pollutants will be included in the permit. The emission limits will be removed from the permit when the facility submits a Title V air quality permit application pursuant to 15A NCAC 2Q .0504 for the boiler (ID No. BH-7) (aka, a “Part 2” permit modification). In an e-mail received on June 16, 2015, the facility also requested to add feed rate limits for ash and hazardous waste to the permit to ensure compliance for cadmium and lead, chromium, and PM under 40 CFR 266. These feed rates were developed for compliance with RCRA regulations governing boilers and industrial furnaces (BIFs) found in 40 CFR Part 266, and as such differ from feed rates developed for compliance with MACT Subpart EEE. The hazardous waste and ash feed rates for boiler BH-7 required for compliance with MACT Subpart EEE will be added to the permit under the “Part 2” significant modification. Mallinckrodt also submitted an application for a permit renewal on May 29, 2014, or at least nine months prior to the expiration date of February 28, 2015. Therefore, the application shield as specified under 15A NCAC 2Q .0512(b) remains in effect. Because the renewed permit has not yet been issued, the expiration date will be changed to June 30, 2020 under this permit modification. A footnote also will be added to the permit stating, “This permit shall expire on the earlier of June 30, 2020 or the date the renewal of Air Permit No. 01479T52 has been issued or denied.” 2. Facility Description Mallinckrodt is a pharmaceutical plant that produces para-aminophenol (PAP) in a continuous chemical process and acetyl-para-aminophenol (APAP) also called acetaminophen in a batch chemical process, as primary products. Acetaminophen is an active ingredient in many prescription and nonprescription pain relievers and cough and cold preparations. The facility also operates an imaging plant that provides a full line of imaging agents and delivery systems, radiopharmaceuticals, and urology imaging systems for the diagnosis and treatment of disease. The plant site also includes six boilers, including two boilers that burn RCRA-regulated waste, a wastewater pre-treatment plant,
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 2 of 14
emergency generators, and various other ancillary operations that are a potential source of air emissions. 3. Application Chronology April 16, 2015
DAQ staff spoke with personnel from Mallinckrodt to discuss testing of boiler BH-7 as required by MACT Subpart EEE. The facility conducted testing in 2013 and 2015 on the boiler and was unable to demonstrate compliance with the chromium emission limit. Mallinckrodt proposed removing the permitted emission limits for cadmium and lead, chromium, and PM under MACT Subpart EEE and complying with the RCRA Part B permit for these pollutants.
April 17, 2015
Katherine O’Neal of the Division of Waste Management sent an e-mail to the DAQ requesting approval of Mallinckrodt’s approach for complying with the RCRA Part B permit for chromium. This request was deemed an applicability determination.
April 22, 2015
Graham Gibson of Mallinckrodt sent an e-mail clarifying the facility intends to comply with cadmium and lead, chromium, and PM via the RCRA Part B permit and not just chromium as implied in Ms. O’Neal’s e-mail.
May 11, 2015
A permit application for a signification modification under 15A NCAC 2Q .0501(c)(2) was received.
May 18, 2015
DAQ issued an applicability determination letter specifying that Mallinckrodt’s compliance approach for cadmium and lead, chromium, and PM was acceptable.
May 20, 2015
Charles McEachern of the Raleigh Regional Office (RRO) provided comments on the permit application.
June 3, 2015
Draft permit and permit review forwarded for comments.
June 3, 2015
Charles McEachern had no comments on the draft permit.
June 12, 2015
Mark Cuilla, Permitting Supervisor, provided comments on the draft permit and permit review.
June 16, 2015
Graham Gibson provided comments on the draft permit. Mr. Gibson also requested to add the feed rates for ash and hazardous waste for boiler BH-7 that were determined during the 2013 initial comprehensive performance testing.
June 23, 2015
A revised draft of the permit and permit review based on the comments received was forwarded for review.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 3 of 14
June 24, 2015
Mark Cuilla had no additional comments on the draft permit.
June 29, 2105
Graham Gibson provided additional comments via e-mail. Betty Gatano discussed the comments with Mark Cuilla and agreed to the changes.
July 6, 2015
Betty Gatano informed Graham Gibson via phone call that the DAQ agreed with Mallinckrodt’s proposed changes.
July 7, 2015
The permit was issued.
4. Permit Modifications/Changes and TVEE Discussion
The following table describes the changes to the current permit under this permit modification. Pages Cover and throughout --
Section -
--
Insignificant Activities List Permit cover page
3–5
Equipment List
15
2.1.D – Regulations Table
16
2.1.D.3.a
18
2.1.D.5.b
18
2.1.D.5.d. and e.
Description of Changes Updated all dates and permit revision numbers. Changed the label on the diesel-fired pump (ID No. IS-WW-6) from “MACT ZZZZ” to “GACT ZZZZ.” Changed the expiration date and added a footnote stating the following: “ This permit shall expire on the earlier of June 30, 2020 or the date the renewal of permit 01479T52 has been issued or denied.” Changed the label on the boilers (ID Nos. PB-1, PB-2, PB-3, and BH5) from “MACT JJJJJJ” to “GACT JJJJJJ.” Changed the labels on the standby diesel generator (ID No. WW-1) and the No. 2 fuel oil-fired emergency generator (ID No. PAR-11) from “MACT ZZZZ” to “GACT ZZZZ.” Changed the label on the gasoline storage tank (ID No. GDF-1) from “MACT CCCCCC” to “GACT CCCCCC.” Modified the compliance options for cadmium and lead, chromium, and PM for boiler (ID No. BH-7). Specifically, the Permittee can comply with either the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE, OR 40 CFR 266.105 and 266.106 for these pollutants. Clarified that 15A NCAC 2D .0521, “Control of Visible Emissions,” is only applicable to boiler (ID No. BH-5) when firing natural gas. This boiler is subject to the opacity standards under the “NSPS for Industrial-Commercial-Institutional Steam Generating Units,” 40 CFR Part 60 Subpart Dc, when firing No. 2 fuel oil. Modified the compliance options for cadmium and lead, chromium, and PM for boiler (ID No. BH-7). Specifically, the Permittee can comply with either the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE, OR 40 CFR 266.105 and 266.106 for these pollutants. Combined common requirements for boilers (ID Nos. BH-2 and BH-7) in the permit to remove redundant language. Renumbered the permit accordingly.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 4 of 14 Pages 19
Section 2.1.D.5.j.ii.(A)
19
2.1.D.5.j.iii.(B)
19
2.1.D.5.j.iv.(B)
19
2.1.D.5.j.v.(B)
19 – 20
2.1.D.5.j.ix
22 -24
2.1.D.5.m.xi. 2.1.D.5.m (old numbering) 2.1.D.5.aa.
26
2.1.D.5.ll.iii
26
2.1.D.5.ll.ix
26
2.1.D.5.nn
28
2.1.D.6.a
30
2.1.D.6.g.ii
Description of Changes Removed the statement specifying that the combined mercury feed rate to both affected boilers shall not exceed 7.80E-5 lb per million Btu. This statement appears to have been applicable to boilers BH-1 and BH-2 and should have been removed when boiler BH-1 was removed from the permit. Added language stating that testing is required if the Permittee elects to comply with the emission limit for particulate matter for boiler (ID No. BH-7) under 40 CFR 63.1217(b) [as specified in permit condition 2.1.D.5.b.(vi)(C)]. Added language stating that testing is required if the Permittee elects to comply with the emission limits for cadmium and lead, combined, for boiler (ID No. BH-7) under 40 CFR 63.1217(b) [as specified under permit condition 2.1.D.5.b.(vi)(A)]. Added language stating that testing is required if the Permittee elects to comply with the emission limits for chromium for boiler (ID No. BH-7) under 40 CFR 63.1217(b) [as specified under permit condition 2.1.D.5.b.(vi)(B)]. Added language for ash and hazardous waste feed rates to ensure compliance with 40 CFR 266.105 and 266.106. Added non-compliance statement. Removed requirements for confirmatory performance testing, which is not applicable to this facility. Clarified permitting language for the operation and maintenance plan as specified in 40 CFR 63.1206(c)(7)(i)(ii)(iv). Added requirement to maintain the startup, shutdown, and malfunction plan as per 40 CFR 63.1211(b). Removed reference to confirmatory performance testing, which is not applicable to this facility. Removed reference to confirmatory performance testing, which is not applicable to this facility. Updated compliance date under the “National Emission Standards for Hazardous Air Pollutants for Industrial, Commercial, and Institutional Boilers at Area Sources,” 40 CFR Part 63, Subpart JJJJJJ. Updated date for submittal of the Notice of Compliance for 40 CFR Part 63, Subpart JJJJJJ.
The Title V Equipment Editor (TVEE) was updated to correct the labels on several pieces of equipment to reference “GACT” rather than “MACT.” 5. Proposed Modification This permit modification will not affect the operation of the K-083 liquid waste/landfill gas/natural gas-fired boiler (ID No. BH-7) nor the emissions from this boiler. The permit is being modified to provide an alternative option for compliance for boiler BH-7 under MACT Subpart EEE, as currently allowed by the rule. Mallinckrodt is also requesting to specify feed rates for boiler BH-7 in the permit to ensure compliance with 40 CFR 266.105 and 266.106. Alternative Emission Standards under MACT Subpart EEE Under Air Permit No. 01479T50 issued on November 13, 2012, Mallinckrodt was permitted to install and operate a new K-083 liquid waste/landfill gas/natural gas-fired boiler (ID No. BH-7) controlled
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 5 of 14
by an existing cloud chamber scrubber system (ID No. CD-CCS). The boiler has two modes of operations – a landfill gas /natural gas burning mode and a tar (i.e., K-083 liquid waste) burning mode. During the landfill gas /natural gas burning mode, steam is produced from the boiler while firing landfill gas, natural gas, or a combination of these fuels. The boiler is isolated from the cloud chamber scrubber (CCS) air pollution control system while operating in this mode, and the combustion gases from the boiler are vented uncontrolled. During the tar burning mode, steam is produced from the boiler while firing K-083 liquid waste as a fuel. Landfill gas and/or natural gas are normally co-fired with the K-083 liquid waste. Combustion gases are controlled by the CCS air pollution control system in this operating mode. The firing of K-083 liquid waste, which is a hazardous waste, in this boiler makes it subject to emission limits and other requirement under MACT Subpart EEE. As an area source of hazardous air pollutants (HAP), the facility chose the elective standards under 40 CFR 63.1217(f), which allows the facility to comply with the standards for cadmium and lead, chromium, hydrogen chloride and chlorine, and PM under MACT EEE in lieu of the standards under 40 CFR 266.105, 266.106, and 266.107 for these pollutants. Mallinckrodt conducted the initial comprehensive performance test for the new boiler as required by MACT Subpart EEE in December 2013 and retested in February 2015. The December 2013 testing did not demonstrate compliance with the PM and chromium emission limits but did demonstrate compliance with all other HAP emissions limits. The February 2015 testing was conducted at revised operating parameters, and Mallinckrodt was able to demonstrate compliance with the PM limit. However, the facility still was unable to pass for chromium,1 because compliance for chromium is determined during testing rather than based on an annual average. Mallinckrodt voluntarily ceased burning hazardous waste in boiler BH-7 after the failed testing. As a result of the testing, the facility is now requesting to revise its TV permit to comply with 40 CFR 266.105 and 266.106 rather than MACT Subpart EEE for cadmium and lead, chromium, and PM from boiler BH-7. This compliance option is allowed pursuant to 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3). The rationale for two compliance options is provided in the preamble to the proposed standards for MACT Subpart EEE, published in the Federal Register on April 20, 2004. In the preamble, the EPA indicated only boilers at major sources of HAP are subject to the full suite of MACT Subpart EEE emission standards. Section 112(c)(3) of the CAA requires the EPA to subject area sources to the full suite of standards applicable to major sources if the EPA finds ‘‘a threat of adverse effects to human health or the environment’’ that warrants such action. The EPA indicated that they could not make this finding for area source boilers. Consequently, area sources are subject to the standards for mercury, dioxin/furan, and destruction and removal efficiency standards under MACT Subpart EEE. RCRA standards under Part 266, Subpart H for PM, metals other than mercury, and hydrogen chloride and chlorine gas apply to area sources unless an area source elects to comply with the major source standards in lieu of the RCRA standards. MACT Subpart EEE clearly provides an alternative path for compliance with the emission standards for PM, metals other than mercury, and hydrogen chloride and chlorine gas from area sources. A 1
The testing showed that mercury (December 2013 tests) and cadmium and lead (both tests) were above the emission limits. However, for cadmium and lead and mercury, MACT Subpart EEE allows sources to emit above the emission limit during a test because compliance is determined on an annual basis. Thus, compliance was demonstrated for these pollutants.
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review of the EPA’s website did not provide any guidance on the permanence of elective standards. In other words, no guidance could be found indicating a facility could not return to complying with RCRA standards after electing to comply with the emission standards for major sources under MACT Subpart EEE. Given the lack of guidance and the clear intent to provide alternative standards under MACT Subpart EEE for area sources, the DAQ concurs that Mallinckrodt can comply with the standards for PM and non-mercury metals via its RCRA Part B permit for boiler BH-7. Hydrogen chloride and chlorine standards under MACT Subpart EEE will remain on the Title V permit, as requested by Mallinckrodt. The facility is pursuing modifications to its RCRA Part B and Title V permits simultaneously. Mallinckrodt submitted a TV permit application on May 11, 2015 to remove emission limits for cadmium and lead, chromium, and PM under MACT EEE for boiler BH-7. The facility will instead comply with the standards for semivolatile metals (lead and cadmium), low volatile metals (arsenic, beryllium, and chromium), and PM under 40 CFR 266.105, and 266.106, which will be incorporated into their RCRA Part B permit. The RCRA Part B permit modification includes a Temporary Authorization pursuant to 40 CFR 270.42(e) followed up by a Class 3 Modification, pursuant to 40 CFR 270.42(c). The facility submitted a Temporary authorization request to the Division of Waste Management (DWM) on May 8, 2015. The DWM provided a draft of the Temporary Authorization to Mallinckrodt on June 3, 2015 for review. Once the Temporary Authorization is issued, Mallinckrodt will be allowed to operate the boiler up to 180 days prior to the issuance of the RCRA Part B permit. According to Graham Gibson, the DWM intends to wait until the Title V permit is issued before issuing the final Temporary Authorization to maximize the 180 day allowance to operate boiler BH-7. Operating Parameters for Boiler BH-7 Mallinckrodt conducted performance testing on boiler BH-7 in December 2013. The facility has requested that the feed rates for hazardous waste and ash determined during the testing be added to the permit to ensure compliance with 40 CFR 266.105 and 40 CFR 266.106. As noted previously, these feed rates differ from feed rates developed for compliance with MACT Subpart EEE. The hazardous waste and ash feed rates for boiler BH-7 required for compliance with MACT Subpart EEE will be added to the permit under the “Part 2” significant modification. The K-083 liquid waste feed rate measured during the December 2013 testing is summarized in the following table. Pursuant to 40 CFR 266.102(e)(6)(i)(B)(2), the operating limit can be established based on the average of the highest hourly rolling average (HRA) value from the valid test runs. As shown in the following table, the demonstrated maximum hazardous waste tar feed rate limit for boiler BH-7 is 1,502 pounds per hour on an HRA basis. Parameter K-083 liquid waste feed rate
Units lb/hr, max. HRA
Run 11 1,501.1
Run 12 1,503.3
Run 13 1,501.6
Average 1,502.0
Boiler BH-7 will comply with the PM emission standard specified in 40 CFR 266.105. The PM emission standard is specified as 180 milligrams per dry standard cubic meter (mg/dscm) or 0.08 grains per dry standard cubic foot (gr/dscf) after correction to a stack gas oxygen content of 7 percent. Also during the December 2013 testing of boiler BH-7, the PM emissions were measured.
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As indicated in the following table, the measured PM emissions during the performance testing satisfied the PM emission standards under 40 CFR 266.105. Run Number Run 11 Run 12 Run 13 Average
Measured PM Emissions mg/dscm at 7% O2 gr/dscf at 7% O2 39.74 0.0174 35.69 0.0156 33.93 0.0148 36.45 0.0159
During the PM emissions testing for boiler BH-7, ash was fed to the unit from both the hazardous waste tar feed stream and from an ash spiking stream. The measured ash feed rates are summarized in the following table. As shown in the table below, the demonstrated maximum ash feed rate limit to ensure compliance with the PM emissions for boiler BH-7 is 1,072 grams per hour on an HRA basis. Parameter Waste Ash Feed Rate Spike Ash Feed Rate Total Ash Feed Rate
Units lb/hr g/hr lb/hr g/hr lb/hr g/hr
Run 11 1.19 539.77 1.50 680.39 2.69 1,220.16
Run 12 0.42 190.51 1.79 811.93 2.21 1,002.44
Run 13 0.59 267.62 1.60 725.75 2.19 993.37
Average 0.73 332.63 1.63 739.35 2.36 1,071.99
6. Regulatory Review This section discusses rules applicable to the natural gas/landfill gas/K-083 liquid waste-fired boiler (ID No. BH-7).
15A NCAC 2D .0503, “Particulates from Fuel Burning Indirect Heat Exchangers” – Boiler BH-7 is subject to 2D .0503. Allowable PM emissions are determined from the equation E = 1.090(Q)-0.2594, where E equals the allowable emission limit for PM in pounds per million Btu and Q equals the maximum heat input in million Btu per hour. The allowable PM emission limit for this boiler is provided in the following table.
Emission Source
Heat Input of the Emission Source (mm Btu/hr)
Maximum Heat Input (mm Btu/hr)
Emission Limit (lbs/mm Btu)
Boiler ID Nos. BH-1 18.6 99.2 0.33 BH-2 30.6 BH-3 50 Boiler ID No. BH-5 96.2 195.4 0.28 Boiler ID Nos. PB-1, PB-2, 6.3, each 214.3 0.27 and PB-3 Boiler ID No. BH-7 66 280.3 0.25 Notes: Boiler BH-1 is no longer in operation and was removed from the permit under Air Permit No. 01479T51 issued
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 8 of 14 Heat Input of the Maximum Heat Emission Limit Emission Source Input (lbs/mm Btu) (mm Btu/hr) (mm Btu/hr) on November 13, 2012. By rule, the removal of a source does not modify the existing emission limits for any source whose limit has been established. Thus, the limits for BH-2 and BH-3 remain as 0.33 pounds per million Btu. Emission Source
As discussed in Permit Application No. 9200349.12D, the worst case emissions of PM result from the firing of K-083 liquid waste in the boiler. The emission factor for this fuel is established as 0.021 pounds of PM per million Btu. Thus, no monitoring, recordkeeping, or reporting is required to ensure compliance for this rule. No changes to permit are needed under this permit modification.
15A NCAC 2D .0516, “Sulfur Dioxide Emissions from Combustion Sources” – Boiler BH-7 is subject to this rule because it combust fuels that contain sulfur compounds. The boiler is limited to a sulfur dioxide (SO2) emission rate of no more than 2.3 pounds SO2 per million Btu heat input.
As discussed in Permit Application No. 9200349.12D, the worst case emissions of SO2 result from the firing of K-083 liquid waste in the boiler. The emission factor for this fuel is established as 0.22 pounds of SO2 per million Btu. Thus, no monitoring, recordkeeping, or reporting is required to ensure compliance for this rule. No changes to permit are needed under this permit modification.
15A NCAC 2D .0521, “Control of Visible Emissions” – Visible emissions from boiler BH-7 shall not exceed 20% opacity when averaged over a six-minute period more than once in any hour and not more than four times in any 24-hour period. In no event shall the six-minute average exceed 87% opacity. Visible emissions are not expect from this boiler, and no monitoring, recordkeeping, or reporting is required to demonstrate compliance with this standard while firing natural gas and landfill gas. No changes to permit are needed under this permit modification.
15A NCAC 2D .0524, “New Source Performance Standards (NSPS)” – Boiler BH-7 is subject to the “NSPS for Small Industrial-Commercial-Institutional Steam Generating Units,” 40 CFR Part 60 Subpart Dc. More discussion of NSPS is provided in Section 7.
15A NCAC 2D .1100 “Control of Toxic Air Pollutants” – Boiler BH-7 was triggered into NC Air Toxics when it was added to the permit under Air Permit No. 01479T50 issued on September 10, 2012. More discussion of NC Air Toxics is provided in Section 7.
15A NCAC 2D .1111 “Maximum Achievable Control Technology (MACT)” – Boiler BH-7 burns hazardous waste and is subject to the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE. More discussion of MACT is provided in Section 7.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 9 of 14
15A NCAC 2Q .0317, “Avoidance Conditions” – Mallinckrodt has accepted a facility-wide avoidance condition for 15A NCAC 2D .0530, Prevention of Significant Deterioration (PSD)” to limit emissions of nitrogen oxides (NOx) and SO2 to less than 100 tons per consecutive 12-month period. More discussion of PSD is provided in Section 7. 7. NSPS, NESHAPS/MACT, NSR/PSD, 112(r), CAM PSD Mallinckrodt is located in Wake County, which is currently designated as attainment or unclassified for all PSD regulated pollutants. The facility is a chemical processing plant, which is one of the 28 listed source categories with major source thresholds of 100 tons per consecutive 12-month period, under 40 CFR 51.166 (b)(1)(i)(a). Mallinckrodt has accepted avoidance conditions to limit emissions of NOx and SO2 to less than 100 tons per consecutive 12-month period to remain a minor source under PSD. This permit modification does not affect the PSD status of the facility, and no changes to the permit are needed. NSPS Mallinckrodt is subject to the following New Source Performance Standards. NSPS Subpart Dc The K-083 liquid waste/landfill gas/natural gas-fired boiler (ID No. BH-7: 66 million Btu per hour) and the natural gas/No. 2 fuel oil/landfill gas-fired boiler (ID No. BH-5: 96.2 million Btu per hour) are subject to the “NSPS for Small Industrial, Commercial, Institutional Steam Generating Units,” 40 CFR Part 60 Subpart Dc. This subpart applies to boilers that are constructed, modified, or reconstructed after June 9, 1989 and have a maximum design heat input capacity > 10 million Btu per hour and < 100 million Btu per hour. The requirements for boilers subject to NSPS Subpart Dc vary based on the size of the boiler and fuel type fired. Neither of the NSPS Subpart Dc boilers fires on wood or coal and, thus, neither of these boilers is subject to the particulate matter standards under this rule. Boiler BH-5, which fires on No. 2 fuel oil, is subject to the SO2 and visible emission standards as discussed below:
Sulfur Dioxide: The maximum sulfur content of any fuel oil received and fired in the boiler shall not exceed 0.5 percent by weight. To demonstrate compliance with this standard, Mallinckrodt is required to retain copies of each fuel supplier certification, including the sulfur content of the oil (in percent by weight). The facility is also required to submit a semiannual report summarizing the monitoring activities (January 30th and July 30th).
Visible Emissions: Under NSPS Subpart Dc, a boiler with a maximum heat input capacity of greater than or equal to 30 million Btu per hour shall not have visible emissions more than 20 percent opacity when averaged over a six-minute period, except for one six-minute period per hour of not more than 27 percent opacity. Oil-fired boilers subject to NSPS Subpart Dc have to conduct Method 9 VE observations at least once every 12 calendar months as per 40 CFR 63.47c (a). The VE monitoring schedule when firing on oil is determined by the actual visible emissions observed during previous testing. The facility has not fired oil since 2009, and the permit requires VE testing when the boiler again begins firing No. 2 fuel oil.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 10 of 14
Both boilers (ID Nos. BH-5 and BH-7) have to record monthly fuel usage as required under NSPS Subpart Dc. No other requirements apply under NSPS Subpart Dc when firing natural gas. This permit modification does not affect NSPS Subpart Dc requirements, and no changes to the permit are needed. NSPS Subpart VV Certain fugitive emission sources in Mallinckrodt’s chemical manufacturing process are subject to “Standards of Performance for Equipment Leaks of VOC in the Synthetic Organic Chemicals Manufacturing Industry for Which Construction, Reconstruction, or Modification Commenced After January 5, 1981, and on or Before November 7, 2006,” 40 CFR Part 60 Subpart VV. This permit modification does not affect the requirements under NSPS Subpart VV, and no changes to the permit are needed. NSPS Subpart NNN The acetaminophen production process (ID No. APAP-1) and process equipment listed in “Confidential Building 205 Equipment List” are subject to “Standards of Performance for Volatile Organic Compound (VOC) Emissions from Synthetic Organic Chemical Manufacturing Industry (SOCMI) Distillation Operations,” 40 CFR Part 60 Subpart NNN. This permit modification does not affect the requirements under NSPS Subpart NNN, and no changes to the permit are needed. MACT/GACT Mallinckrodt is subject to the following MACT/GACTs. MACT Subpart EEE Boilers BH-2 and BH-7 are permitted to fire K-083 liquid waste, which is an aniline tar liquid waste stream generated from the PAP manufacturing process. K-083 liquid waste also meets the definition of hazardous waste. By firing K-083 liquid waste, boilers BH-2 and BH-7 are subject to “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE. Both boilers are considered liquid fired boilers (LFB) under MACT EEE. As per 40 CFR 63.1206(a)(2)(ii)(A), a new emission source is one in which construction or reconstruction was commenced after April 20, 2004. Boiler BH-2 is considered an existing source and boiler BH-7 is a considered new source under MACT Subpart EEE based on this date. The requirements under MACT Subpart EEE are extensive. The facility has to meet emission limits for numerous pollutants, develop and implement a feed stream analysis plan, conduct initial and periodic comprehensive performance testing, meet operating limits, ensure operator testing and certification, and meet other monitoring, recordkeeping, and reporting requirements. The emission limits for LFB are based on the type of air pollution control system, the heat content of the hazardous waste2, and the HAP status of the facility. Area sources of HAPs are 2
The heat content of the K-083 liquid waste is greater than 10,000 Btu/lb, as discussed in the permit review for Air Permit No. 01479T46 (Fern Patterson, March 17, 2010).
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 11 of 14
subject to the standards for dioxin and furans (if applicable), mercury, carbon monoxide, and hydrocarbon. They are also subject to the destruction and removal efficiency (DRE) standards. As noted previously, area sources of HAPs are not subject to the cadmium and lead, chromium, hydrogen chloride and chlorine, and PM standards under MACT EEE. They comply with 40 CFR 266.105, 266.106, and 266.107 via their RCRA Part B permit for these pollutants. However, MACT Subpart EEE provides the option for area sources to comply with the elective standards for these pollutants under MACT EEE in lieu of the standards under 40 CFR 266.105, 266.106, and 266.107. A summary of the emission limits are provided in the table below. Emission Limits DRE Dioxin and Furans Mercury Carbon Monoxide Hydrocarbons
Boiler BH-2 (Existing LFB)
Boiler BH-7 (New LFB)
99.99 % 99.99 % Per 40 CFR 63.1217(a)(1)(ii) and (b)(1)(ii), sources not equipped with a dry air pollution control system comply with either the carbon monoxide or hydrocarbon in excess emission limits. 4.2E-05 lbs/MMBtu on an annual 1.2E-6 lbs/MM Btu on an annual averaging averaging period period 100 ppmdv, corrected to 7% oxygen, 100 ppmdv, corrected to 7% oxygen, on a on a rolling hourly average rolling hourly average 10 ppmdv, corrected to 7% oxygen, 10 ppmdv, corrected to 7% oxygen, on a on a rolling hourly average, reported rolling hourly average, reported as propane as propane
Hydrogen chloride and chlorine1
5.1E-02 lbs/MMBtu
Cadmium and Lead
8.2E-05 lbs/MMBtu on an annual averaging period2
Chromium
1.3E-04 lbs/MMBtu2
Particulate Matter
80 mg/dscm, corrected to 7% oxygen2
5.1E-02 lbs/MMBtu Mallinckrodt can elect to comply with the standards for cadmium, lead, chromium and particulate matter under 40 CFR 266.105 and 266.106 OR They can elect to comply with the following emission limits under 40 CFR 63.1217(b): Cadmium and lead, combined: 6.2E-06 lbs/MMBtu on an annual averaging period. Chromium: 1.4E-05 lbs/MMBtu. PM : 20 mg/dscm, corrected to 7% oxygen.
Notes: 1. Per 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3), Mallinckrodt can comply with the standards for hydrogen chloride and chlorine under 40 CFR 266.107 or they can comply with the emission limit under 40 CFR 63.1217. The facility has elected to comply with the MACT Subpart EEE emission limit for these HAPs for both boilers. 2. Per 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3), Mallinckrodt can comply with the standards for cadmium, lead, chromium and particulate matter 40 CFR 266.105 and 40 CFR 266.106 or they can comply with the emission limits under 40 CFR 63.1217. The facility has elected to comply with the MACT Subpart EEE emission limit for these HAPs for boiler BH-2.
As discussed earlier, Mallinckrodt is electing to comply with standards for cadmium and lead, chromium, and PM in 40 CFR 266.105 and 266.106. The permit will be modified to specify both compliance options – MACT Subpart EEE or 40 CFR 266.105 and 266.106 – for cadmium and lead, chromium, and PM for boiler BH-7 under this permit modification.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 12 of 14
The permit condition for MACT Subpart EEE will also be “cleaned up” under this permit modification. One change to note in this cleanup involves the confirmatory performance test requirements under MACT Subpart EEE. As specified in 40 CFR 63.1207(b)(2), confirmatory performance tests are required to demonstrate compliance with the dioxin/furan emission standard. However in 40 CFR 63.12179(a)(i) and (b)(i), MACT Subpart EEE states the dioxin/furan standards are only applicable to facilities that use dry air pollution control systems. Facilities not equipped with a dry air pollution control system instead comply with the carbon monoxide or hydrocarbon emissions standards, per 40 CFR 63.12179(a)(ii) and (b)(ii). Mallinckrodt controls emissions from boilers BH-2 and BH-7 with a CCS, which is not a dry air pollution control system. Therefore, Mallinckrodt is not subject to the dioxin/furan standards, and confirmatory testing is not required. The confirmatory performance test requirements will be removed under this permit modification. GACT Subpart ZZZZ The diesel-fired fire pump (ID No. I-WW-6), the standby diesel generator (ID No. WW-1), and the No. 2 fuel oil-fired emergency generator (ID No. PAR-11) are subject to the “NESHAP for Stationary Reciprocating Internal Combustion Engines,” 40 CFR Part 63 Subpart ZZZZ. This modification does not affect these engines, and no change to the permit is needed. However, this permit condition will be updated at the next permit renewal. GACT Subpart CCCCCC The gasoline storage tank (ID No. GDF-1) is subject to the “NESHAP for Gasoline Dispensing Facilities,” or GACT Subpart CCCCCC. This modification does not affect this tank, and no change to the permit is needed. GACT Subpart JJJJJJ [Mallinckrodt] is classified as an area source of HAPs, and the boilers (ID Nos. B2, B3, B4, B5, B6, B8, and ES-A3-2-B7) are subject to the “NESHAP for Area Sources: Industrial, Commercial, and Institutional Boilers,” or GACT Subpart 6J. These boilers were constructed prior to June 4, 2010 and are considered to be existing boilers under this rule. Additionally, the boilers fall in the oil subcategory under the rule because they “[burn] any liquid fuel and [are] not in either the biomass or coal subcategories.” Although they also fire on natural gas, they do not meet naturalgas exemptions under GACT Subpart 6J. The boilers are subject to work practice standards, including an initial tune-up, which was due no later than March 21, 2014. Additional tune-ups are due biennially. The natural gas-fired hot oil heaters (ID No. IB7 and IB8) are NOT subject to GACT 6J because the definition of boiler explicitly excludes process heaters, such as oil heaters. Per the definition under 40 CFR 63.11237, “Process heaters include units that heat water/water mixtures for pool heating, sidewalk heating, cooling tower water heating, power washing, or oil heating.” This permit modification does not affect these boilers or the facility’s status with respect to GACT Subpart JJJJJJ. Changes were made to update the permit with the most current permitting language under this permit renewal. 112(r)
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The facility is subject to Section 112(r) of the Clean Air Act requirements because it stores anhydrous ammonia in quantities above the threshold quantity in the Rule. This permit modification does not affect the 112(r) status, and no changes to the permit are needed. However, this permit condition will be updated at the next permit renewal. CAM Mallinckrodt is not subject to 40 CFR Part 64 CAM, and this permit modification does not affect the CAM status. 8. Facility Wide Air Toxics Mallinckrodt has existing emissions limitations for several toxic air pollutants (TAPs) based on previously submitted compliance demonstrations consistent with the requirements in 15A NCAC 2D .1100. This permit modification does not affect the status with respect to 2D .1100, and no changes to the permit are needed. Additionally, Mallinckrodt has previously demonstrated that the TAPs listed in Section 2.2.A.3 of the permit are below their Toxics Permitting Emission Rate, in accordance with 2Q .0711. This permit modification does not affect the status with respect to 2Q .0711, and no changes to the permit are needed. 9. Facility Emissions Review There is no change in Title V potential emissions under this permit modification. Actual emissions for 2010 through 2014 are reported in the header of this permit review. Additionally, the permit application submitted on May 11, 2015 indicated that Mallinckrodt has potential emissions of 173,488 metric tons of CO2 equivalents.3 10. Compliance Status The most recent compliance inspection was conducted on September 14, 2014 by Will Wike of the RRO. The facility appeared to be in compliance with all applicable requirements at that time. 11. Other Regulatory Considerations
A P.E. seal is required for this application and was provided in the permit application submitted on May 11, 2015. A zoning consistency determination is NOT required for this application. A permit application fee of $918 is required and was submitted with the permit application.
12. Recommendations The permit modification application for Mallinckrodt - Raleigh Pharmaceutical Plant located in Raleigh, Wake County, NC has been reviewed by DAQ to determine compliance with all procedures 3
CO2 equivalent is defined as the sum of individual greenhouse gas pollutant emission times their global warming potential, converted to metric tons.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 2 of 14
and requirements. DAQ has determined that this facility is complying or will achieve compliance, as specified in the permit, with all requirements that are applicable to the affected sources. The DAQ recommends the issuance of Air Permit No. 01479T53, requiring the submittal of a TV permit application within one-year of permit issuance.
Attachment 3 to review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant
Comments on Initial Drafts
Will Wike, by phonecall on August 18, 2016 The T53 permit review attached to the draft contains information that is no longer relevant or correct. The facility has undergone some changes since this review was published. Should it still be included in this current review? Response: With the 2-step process, we always include the original 1st step review as an attachment. It may no longer be current, but it contains the information originally used to modify the permit.
Will Wike, by email on August 18, 2016 1. There is a typo in the T53 permit review. At one point it refers to "Akzo Nobel" instead of Mallinckrodt. Response: I have corrected this typo. 2. The permitted emission source list has an asterisk associated with BH-7 that should be removed. Response: Fixed.
Mark Cuilla, by email on August 19, 2016 1. The draft review has the dates of emission testing and the issuance of permit T53 in the wrong order. Response: Fixed. 2. Mark pointed out typos in the review and permit. Response: Fixed. 3. Mark suggested that Paragraph 2.1.D.5.j.ix. not be removed. Response: After speaking with Mark, I agree that this paragraph should remain in the permit. It has been changed to reflect Mallinckrodt's choice to use 40 CFR 266.105 and .106.
Charles McEachern, by email on August 24, 2016 Charles asked that the review have a better explanation for why this permit application is necessary. It should discuss the Part I and II requirements. Response: I have added this to the review discussion.
NORTH CAROLINA DIVISION OF AIR QUALITY
Air Permit Review Permit Issue Date: Facility Data Applicant (Facility’s Name): Mallinckrodt - Raleigh Pharmaceutical Plant
SIP: 02D .1111 NSPS: NESHAP: MACT Subpart EEE PSD: PSD Avoidance: NC Toxics: 112(r): Other:
Facility Address: Mallinckrodt - Raleigh Pharmaceutical Plant 8801 Capital Boulevard Raleigh, NC 27616 SIC: 2833 / Medicinals And Botanicals NAICS: 325411 / Medicinal and Botanical Manufacturing Facility Classification: Before: Title V After: Title V Fee Classification: Before: Title V After: Title V Contact Data Facility Contact Timothy Roberts Environmental Manager (919) 878-2895 8801 Capital Boulevard Raleigh, NC 27616
Authorized Contact Timothy Goodman Site Director (919) 878-2822 8801 Capital Boulevard Raleigh, NC 27616
Application Data Technical Contact
Application Number: 9200349.16A Date Received: 07/07/2016 Application Type: Modification Application Schedule: TV-Sign-501(c)(2) Part II Existing Permit Data Existing Permit Number: 01479/T55 Existing Permit Issue Date: 04/21/2016 Existing Permit Expiration Date: 09/30/2020
Graham Gibson Sr. Environmental Engineer, EHS (919) 878-2885 8801 Capital Boulevard Raleigh, NC 27616
Total Actual emissions in TONS/YEAR: CY
SO2
NOX
VOC
CO
PM10
Total HAP
Largest HAP
2014
17.74
51.51
19.29
32.03
9.34
8.69
4.14 [Aniline]
2013
8.18
49.52
18.02
34.75
10.75
8.82
4.07 [Aniline]
2012
8.65
46.99
19.02
35.09
10.05
9.30
4.18 [Nitrobenzene]
2011
8.83
46.20
20.07
36.84
10.34
9.58
4.73 [Nitrobenzene]
2010
35.53
36.90
16.92
34.48
9.52
7.87
3.17 [Aniline]
Review Engineer: Russell Braswell Review Engineer’s Signature:
Date:
Comments / Recommendations: Issue 01479/T56 Permit Issue Date: Permit Expiration Date:
Review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant Page 2 of 3
1. Purpose of Application: Mallinckrodt - Raleigh Pharmaceutical Plant (Mallinckrodt) was issued Air Quality Permit 01479T53 on July 7, 2015. This permit action changed compliance options for boiler BH-7 under MACT Subpart EEE. The permit application was processed as the first step of a 2-step significant modification (see 02Q .0501(c)(2)). 02Q .0501(c)(2) requires that a second permit application be submitted within 12 months of the first step being implemented. Between the issuance of T43 and the current date, two other permits were issued to Mallinckrodt. Neither of these permit actions dealt with the 02Q .0501(c)(2) requirement. Therefore, Mallinckrodt has submitted this permit application. 2. Facility Description: "Mallinckrodt is a facility that primarily manufactures acetaminophen, an analgesic found in pain and cold medications. Currently, this facility manufactures the majority of the U.S. supply of acetaminophen. In the PAP and APAP plants, a range of raw chemical by-products are also produced, including aniline, acetic acid, ammonium sulfate (for fertilizer), and KO83 tar (which is used for fuel in two boilers)."1 3. Application Chronology:
July 7, 2016
Application received.
August 18, 2016
An initial draft of the permit and review were sent to DAQ staff (Tom Anderson, Mark Cuilla, Samir Parekh, Will Wike, Charles McEachern) and Mallinkrodt staff (Graham Gibson). For a summary of comments received, see Attachment 3.
XXXX
Public / EPA notice
XXXX
Permit issued.
4. Permit Modifications and Regulatory Review: The boiler BH-7 is subject to 40 CFR Part 63 Subpart EEE "National Emission Standards for Hazardous Air Pollutants from Hazardous Waste Combustors" (referred to as "Subpart EEE"). This rule contains emission standards for several pollutants and requires an initial compliance demonstration for each pollutant. 40 CFR 63.1217(f) allows subject facilities to comply with the emission standards in 40 CFR 266.105 and .106 in lieu of Subpart EEE for the following pollutants: PM, chromium, cadmium, and lead. As a result of emission testing, Mallinckrodt has elected to use this option. In the T53 permit (Betty Gatano, July 7, 2015), Mallinckrodt was allowed to demonstrate compliance using the option under 63.1217(f) or the emission limits in Subpart EEE. See Attachment 2 for the permit review associated with T53. Mallinckrodt performed the compliance demonstrations between October and December 2013, and then re-tested during February 2015. Based on these test results and discussions with NC Division of Waste 1
From Will Wike's inspection report dated July 30, 2015.
Review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant Page 3 of 3
Management, Mallinckrodt has ultimately decided to rely on the compliance option in 40 CFR 63.1217(f). The permit condition for Subpart EEE has been updated to reflect the parameters used during the emission testing and Mallinckrodt's election to comply under 40 CFR 266.105 and .106. Note that compliance under 40 CFR 266.105 and .106 is determined by the NC Division of Waste Management, not Air Quality. 5. Public Notice/EPA and Affected State(s) Review A notice of the DRAFT Title V Permit shall be made pursuant to 15A NCAC 2Q .0521. The notice will provide for a 30-day comment period, with an opportunity for a public hearing. Copies of the public notice shall be sent to persons on the Title V mailing list and EPA. Pursuant to 15A NCAC 2Q .0522, a copy of each permit application, each proposed permit and each final permit pursuant shall be provided to EPA. Also pursuant to 2Q .0522, a notice of the DRAFT Title V Permit shall be provided to each affected State at or before the time notice provided to the public under 2Q .0521 above. 6. Recommendations Issue permit 01479T56.
Attachment 1 to review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant
Change List Pages Throughout
Section Throughout 2.1.D.5.
Description of Changes Updated dates, permit, and application numbers Updated section to reflect recent testing results and compliance with 40 CFR 266.105 and .106.
Attachment 2 to review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant Page 1 of 14
T53 Permit Review (Betty Gatano, July 7, 2015)
1. Purpose of Application Mallinckrodt - Raleigh Pharmaceutical Plant (Mallinckrodt) currently holds Title V Permit No. 01479T52 with an expiration date of February 28, 2015 for a pharmaceutical manufacturing facility in Raleigh, Wake County, North Carolina. A permit application for a significant modification under 15A NCAC 2Q .0501(c)(2) was received on May 11, 2015. In the permit application, the facility proposed removing emission limits for boiler (ID No. BH-7) for cadmium and lead, chromium, and particulate matter (PM) under the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE, and complying instead with the Resource and Recovery Act (RCRA) Part B permit for these pollutants. This compliance option is allowed pursuant to 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3). Because the permit application was submitted as a significant modification under 15A NCAC 2Q .0501(c)(2), the emission limits for cadmium and lead, chromium, and PM under MACT Subpart EEE cannot be removed under this permit process/schedule. Instead, both compliance options for these pollutants will be included in the permit. The emission limits will be removed from the permit when the facility submits a Title V air quality permit application pursuant to 15A NCAC 2Q .0504 for the boiler (ID No. BH-7) (aka, a “Part 2” permit modification). In an e-mail received on June 16, 2015, the facility also requested to add feed rate limits for ash and hazardous waste to the permit to ensure compliance for cadmium and lead, chromium, and PM under 40 CFR 266. These feed rates were developed for compliance with RCRA regulations governing boilers and industrial furnaces (BIFs) found in 40 CFR Part 266, and as such differ from feed rates developed for compliance with MACT Subpart EEE. The hazardous waste and ash feed rates for boiler BH-7 required for compliance with MACT Subpart EEE will be added to the permit under the “Part 2” significant modification. Mallinckrodt also submitted an application for a permit renewal on May 29, 2014, or at least nine months prior to the expiration date of February 28, 2015. Therefore, the application shield as specified under 15A NCAC 2Q .0512(b) remains in effect. Because the renewed permit has not yet been issued, the expiration date will be changed to June 30, 2020 under this permit modification. A footnote also will be added to the permit stating, “This permit shall expire on the earlier of June 30, 2020 or the date the renewal of Air Permit No. 01479T52 has been issued or denied.” 2. Facility Description Mallinckrodt is a pharmaceutical plant that produces para-aminophenol (PAP) in a continuous chemical process and acetyl-para-aminophenol (APAP) also called acetaminophen in a batch chemical process, as primary products. Acetaminophen is an active ingredient in many prescription and nonprescription pain relievers and cough and cold preparations. The facility also operates an imaging plant that provides a full line of imaging agents and delivery systems, radiopharmaceuticals, and urology imaging systems for the diagnosis and treatment of disease. The plant site also includes six boilers, including two boilers that burn RCRA-regulated waste, a wastewater pre-treatment plant,
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 2 of 14
emergency generators, and various other ancillary operations that are a potential source of air emissions. 3. Application Chronology April 16, 2015
DAQ staff spoke with personnel from Mallinckrodt to discuss testing of boiler BH-7 as required by MACT Subpart EEE. The facility conducted testing in 2013 and 2015 on the boiler and was unable to demonstrate compliance with the chromium emission limit. Mallinckrodt proposed removing the permitted emission limits for cadmium and lead, chromium, and PM under MACT Subpart EEE and complying with the RCRA Part B permit for these pollutants.
April 17, 2015
Katherine O’Neal of the Division of Waste Management sent an e-mail to the DAQ requesting approval of Mallinckrodt’s approach for complying with the RCRA Part B permit for chromium. This request was deemed an applicability determination.
April 22, 2015
Graham Gibson of Mallinckrodt sent an e-mail clarifying the facility intends to comply with cadmium and lead, chromium, and PM via the RCRA Part B permit and not just chromium as implied in Ms. O’Neal’s e-mail.
May 11, 2015
A permit application for a signification modification under 15A NCAC 2Q .0501(c)(2) was received.
May 18, 2015
DAQ issued an applicability determination letter specifying that Mallinckrodt’s compliance approach for cadmium and lead, chromium, and PM was acceptable.
May 20, 2015
Charles McEachern of the Raleigh Regional Office (RRO) provided comments on the permit application.
June 3, 2015
Draft permit and permit review forwarded for comments.
June 3, 2015
Charles McEachern had no comments on the draft permit.
June 12, 2015
Mark Cuilla, Permitting Supervisor, provided comments on the draft permit and permit review.
June 16, 2015
Graham Gibson provided comments on the draft permit. Mr. Gibson also requested to add the feed rates for ash and hazardous waste for boiler BH-7 that were determined during the 2013 initial comprehensive performance testing.
June 23, 2015
A revised draft of the permit and permit review based on the comments received was forwarded for review.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 3 of 14
June 24, 2015
Mark Cuilla had no additional comments on the draft permit.
June 29, 2105
Graham Gibson provided additional comments via e-mail. Betty Gatano discussed the comments with Mark Cuilla and agreed to the changes.
July 6, 2015
Betty Gatano informed Graham Gibson via phone call that the DAQ agreed with Mallinckrodt’s proposed changes.
July 7, 2015
The permit was issued.
4. Permit Modifications/Changes and TVEE Discussion
The following table describes the changes to the current permit under this permit modification. Pages Cover and throughout --
Section -
--
Insignificant Activities List Permit cover page
3–5
Equipment List
15
2.1.D – Regulations Table
16
2.1.D.3.a
18
2.1.D.5.b
18
2.1.D.5.d. and e.
Description of Changes Updated all dates and permit revision numbers. Changed the label on the diesel-fired pump (ID No. IS-WW-6) from “MACT ZZZZ” to “GACT ZZZZ.” Changed the expiration date and added a footnote stating the following: “ This permit shall expire on the earlier of June 30, 2020 or the date the renewal of permit 01479T52 has been issued or denied.” Changed the label on the boilers (ID Nos. PB-1, PB-2, PB-3, and BH5) from “MACT JJJJJJ” to “GACT JJJJJJ.” Changed the labels on the standby diesel generator (ID No. WW-1) and the No. 2 fuel oil-fired emergency generator (ID No. PAR-11) from “MACT ZZZZ” to “GACT ZZZZ.” Changed the label on the gasoline storage tank (ID No. GDF-1) from “MACT CCCCCC” to “GACT CCCCCC.” Modified the compliance options for cadmium and lead, chromium, and PM for boiler (ID No. BH-7). Specifically, the Permittee can comply with either the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE, OR 40 CFR 266.105 and 266.106 for these pollutants. Clarified that 15A NCAC 2D .0521, “Control of Visible Emissions,” is only applicable to boiler (ID No. BH-5) when firing natural gas. This boiler is subject to the opacity standards under the “NSPS for Industrial-Commercial-Institutional Steam Generating Units,” 40 CFR Part 60 Subpart Dc, when firing No. 2 fuel oil. Modified the compliance options for cadmium and lead, chromium, and PM for boiler (ID No. BH-7). Specifically, the Permittee can comply with either the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE, OR 40 CFR 266.105 and 266.106 for these pollutants. Combined common requirements for boilers (ID Nos. BH-2 and BH-7) in the permit to remove redundant language. Renumbered the permit accordingly.
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Section 2.1.D.5.j.ii.(A)
19
2.1.D.5.j.iii.(B)
19
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2.1.D.5.m.xi. 2.1.D.5.m (old numbering) 2.1.D.5.aa.
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2.1.D.5.nn
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Description of Changes Removed the statement specifying that the combined mercury feed rate to both affected boilers shall not exceed 7.80E-5 lb per million Btu. This statement appears to have been applicable to boilers BH-1 and BH-2 and should have been removed when boiler BH-1 was removed from the permit. Added language stating that testing is required if the Permittee elects to comply with the emission limit for particulate matter for boiler (ID No. BH-7) under 40 CFR 63.1217(b) [as specified in permit condition 2.1.D.5.b.(vi)(C)]. Added language stating that testing is required if the Permittee elects to comply with the emission limits for cadmium and lead, combined, for boiler (ID No. BH-7) under 40 CFR 63.1217(b) [as specified under permit condition 2.1.D.5.b.(vi)(A)]. Added language stating that testing is required if the Permittee elects to comply with the emission limits for chromium for boiler (ID No. BH-7) under 40 CFR 63.1217(b) [as specified under permit condition 2.1.D.5.b.(vi)(B)]. Added language for ash and hazardous waste feed rates to ensure compliance with 40 CFR 266.105 and 266.106. Added non-compliance statement. Removed requirements for confirmatory performance testing, which is not applicable to this facility. Clarified permitting language for the operation and maintenance plan as specified in 40 CFR 63.1206(c)(7)(i)(ii)(iv). Added requirement to maintain the startup, shutdown, and malfunction plan as per 40 CFR 63.1211(b). Removed reference to confirmatory performance testing, which is not applicable to this facility. Removed reference to confirmatory performance testing, which is not applicable to this facility. Updated compliance date under the “National Emission Standards for Hazardous Air Pollutants for Industrial, Commercial, and Institutional Boilers at Area Sources,” 40 CFR Part 63, Subpart JJJJJJ. Updated date for submittal of the Notice of Compliance for 40 CFR Part 63, Subpart JJJJJJ.
The Title V Equipment Editor (TVEE) was updated to correct the labels on several pieces of equipment to reference “GACT” rather than “MACT.” 5. Proposed Modification This permit modification will not affect the operation of the K-083 liquid waste/landfill gas/natural gas-fired boiler (ID No. BH-7) nor the emissions from this boiler. The permit is being modified to provide an alternative option for compliance for boiler BH-7 under MACT Subpart EEE, as currently allowed by the rule. Mallinckrodt is also requesting to specify feed rates for boiler BH-7 in the permit to ensure compliance with 40 CFR 266.105 and 266.106. Alternative Emission Standards under MACT Subpart EEE Under Air Permit No. 01479T50 issued on November 13, 2012, Mallinckrodt was permitted to install and operate a new K-083 liquid waste/landfill gas/natural gas-fired boiler (ID No. BH-7) controlled
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 5 of 14
by an existing cloud chamber scrubber system (ID No. CD-CCS). The boiler has two modes of operations – a landfill gas /natural gas burning mode and a tar (i.e., K-083 liquid waste) burning mode. During the landfill gas /natural gas burning mode, steam is produced from the boiler while firing landfill gas, natural gas, or a combination of these fuels. The boiler is isolated from the cloud chamber scrubber (CCS) air pollution control system while operating in this mode, and the combustion gases from the boiler are vented uncontrolled. During the tar burning mode, steam is produced from the boiler while firing K-083 liquid waste as a fuel. Landfill gas and/or natural gas are normally co-fired with the K-083 liquid waste. Combustion gases are controlled by the CCS air pollution control system in this operating mode. The firing of K-083 liquid waste, which is a hazardous waste, in this boiler makes it subject to emission limits and other requirement under MACT Subpart EEE. As an area source of hazardous air pollutants (HAP), the facility chose the elective standards under 40 CFR 63.1217(f), which allows the facility to comply with the standards for cadmium and lead, chromium, hydrogen chloride and chlorine, and PM under MACT EEE in lieu of the standards under 40 CFR 266.105, 266.106, and 266.107 for these pollutants. Mallinckrodt conducted the initial comprehensive performance test for the new boiler as required by MACT Subpart EEE in December 2013 and retested in February 2015. The December 2013 testing did not demonstrate compliance with the PM and chromium emission limits but did demonstrate compliance with all other HAP emissions limits. The February 2015 testing was conducted at revised operating parameters, and Mallinckrodt was able to demonstrate compliance with the PM limit. However, the facility still was unable to pass for chromium,1 because compliance for chromium is determined during testing rather than based on an annual average. Mallinckrodt voluntarily ceased burning hazardous waste in boiler BH-7 after the failed testing. As a result of the testing, the facility is now requesting to revise its TV permit to comply with 40 CFR 266.105 and 266.106 rather than MACT Subpart EEE for cadmium and lead, chromium, and PM from boiler BH-7. This compliance option is allowed pursuant to 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3). The rationale for two compliance options is provided in the preamble to the proposed standards for MACT Subpart EEE, published in the Federal Register on April 20, 2004. In the preamble, the EPA indicated only boilers at major sources of HAP are subject to the full suite of MACT Subpart EEE emission standards. Section 112(c)(3) of the CAA requires the EPA to subject area sources to the full suite of standards applicable to major sources if the EPA finds ‘‘a threat of adverse effects to human health or the environment’’ that warrants such action. The EPA indicated that they could not make this finding for area source boilers. Consequently, area sources are subject to the standards for mercury, dioxin/furan, and destruction and removal efficiency standards under MACT Subpart EEE. RCRA standards under Part 266, Subpart H for PM, metals other than mercury, and hydrogen chloride and chlorine gas apply to area sources unless an area source elects to comply with the major source standards in lieu of the RCRA standards. MACT Subpart EEE clearly provides an alternative path for compliance with the emission standards for PM, metals other than mercury, and hydrogen chloride and chlorine gas from area sources. A 1
The testing showed that mercury (December 2013 tests) and cadmium and lead (both tests) were above the emission limits. However, for cadmium and lead and mercury, MACT Subpart EEE allows sources to emit above the emission limit during a test because compliance is determined on an annual basis. Thus, compliance was demonstrated for these pollutants.
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review of the EPA’s website did not provide any guidance on the permanence of elective standards. In other words, no guidance could be found indicating a facility could not return to complying with RCRA standards after electing to comply with the emission standards for major sources under MACT Subpart EEE. Given the lack of guidance and the clear intent to provide alternative standards under MACT Subpart EEE for area sources, the DAQ concurs that Mallinckrodt can comply with the standards for PM and non-mercury metals via its RCRA Part B permit for boiler BH-7. Hydrogen chloride and chlorine standards under MACT Subpart EEE will remain on the Title V permit, as requested by Mallinckrodt. The facility is pursuing modifications to its RCRA Part B and Title V permits simultaneously. Mallinckrodt submitted a TV permit application on May 11, 2015 to remove emission limits for cadmium and lead, chromium, and PM under MACT EEE for boiler BH-7. The facility will instead comply with the standards for semivolatile metals (lead and cadmium), low volatile metals (arsenic, beryllium, and chromium), and PM under 40 CFR 266.105, and 266.106, which will be incorporated into their RCRA Part B permit. The RCRA Part B permit modification includes a Temporary Authorization pursuant to 40 CFR 270.42(e) followed up by a Class 3 Modification, pursuant to 40 CFR 270.42(c). The facility submitted a Temporary authorization request to the Division of Waste Management (DWM) on May 8, 2015. The DWM provided a draft of the Temporary Authorization to Mallinckrodt on June 3, 2015 for review. Once the Temporary Authorization is issued, Mallinckrodt will be allowed to operate the boiler up to 180 days prior to the issuance of the RCRA Part B permit. According to Graham Gibson, the DWM intends to wait until the Title V permit is issued before issuing the final Temporary Authorization to maximize the 180 day allowance to operate boiler BH-7. Operating Parameters for Boiler BH-7 Mallinckrodt conducted performance testing on boiler BH-7 in December 2013. The facility has requested that the feed rates for hazardous waste and ash determined during the testing be added to the permit to ensure compliance with 40 CFR 266.105 and 40 CFR 266.106. As noted previously, these feed rates differ from feed rates developed for compliance with MACT Subpart EEE. The hazardous waste and ash feed rates for boiler BH-7 required for compliance with MACT Subpart EEE will be added to the permit under the “Part 2” significant modification. The K-083 liquid waste feed rate measured during the December 2013 testing is summarized in the following table. Pursuant to 40 CFR 266.102(e)(6)(i)(B)(2), the operating limit can be established based on the average of the highest hourly rolling average (HRA) value from the valid test runs. As shown in the following table, the demonstrated maximum hazardous waste tar feed rate limit for boiler BH-7 is 1,502 pounds per hour on an HRA basis. Parameter K-083 liquid waste feed rate
Units lb/hr, max. HRA
Run 11 1,501.1
Run 12 1,503.3
Run 13 1,501.6
Average 1,502.0
Boiler BH-7 will comply with the PM emission standard specified in 40 CFR 266.105. The PM emission standard is specified as 180 milligrams per dry standard cubic meter (mg/dscm) or 0.08 grains per dry standard cubic foot (gr/dscf) after correction to a stack gas oxygen content of 7 percent. Also during the December 2013 testing of boiler BH-7, the PM emissions were measured.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 7 of 14
As indicated in the following table, the measured PM emissions during the performance testing satisfied the PM emission standards under 40 CFR 266.105. Run Number Run 11 Run 12 Run 13 Average
Measured PM Emissions mg/dscm at 7% O2 gr/dscf at 7% O2 39.74 0.0174 35.69 0.0156 33.93 0.0148 36.45 0.0159
During the PM emissions testing for boiler BH-7, ash was fed to the unit from both the hazardous waste tar feed stream and from an ash spiking stream. The measured ash feed rates are summarized in the following table. As shown in the table below, the demonstrated maximum ash feed rate limit to ensure compliance with the PM emissions for boiler BH-7 is 1,072 grams per hour on an HRA basis. Parameter Waste Ash Feed Rate Spike Ash Feed Rate Total Ash Feed Rate
Units lb/hr g/hr lb/hr g/hr lb/hr g/hr
Run 11 1.19 539.77 1.50 680.39 2.69 1,220.16
Run 12 0.42 190.51 1.79 811.93 2.21 1,002.44
Run 13 0.59 267.62 1.60 725.75 2.19 993.37
Average 0.73 332.63 1.63 739.35 2.36 1,071.99
6. Regulatory Review This section discusses rules applicable to the natural gas/landfill gas/K-083 liquid waste-fired boiler (ID No. BH-7).
15A NCAC 2D .0503, “Particulates from Fuel Burning Indirect Heat Exchangers” – Boiler BH-7 is subject to 2D .0503. Allowable PM emissions are determined from the equation E = 1.090(Q)-0.2594, where E equals the allowable emission limit for PM in pounds per million Btu and Q equals the maximum heat input in million Btu per hour. The allowable PM emission limit for this boiler is provided in the following table.
Emission Source
Heat Input of the Emission Source (mm Btu/hr)
Maximum Heat Input (mm Btu/hr)
Emission Limit (lbs/mm Btu)
Boiler ID Nos. BH-1 18.6 99.2 0.33 BH-2 30.6 BH-3 50 Boiler ID No. BH-5 96.2 195.4 0.28 Boiler ID Nos. PB-1, PB-2, 6.3, each 214.3 0.27 and PB-3 Boiler ID No. BH-7 66 280.3 0.25 Notes: Boiler BH-1 is no longer in operation and was removed from the permit under Air Permit No. 01479T51 issued
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 8 of 14 Heat Input of the Maximum Heat Emission Limit Emission Source Input (lbs/mm Btu) (mm Btu/hr) (mm Btu/hr) on November 13, 2012. By rule, the removal of a source does not modify the existing emission limits for any source whose limit has been established. Thus, the limits for BH-2 and BH-3 remain as 0.33 pounds per million Btu. Emission Source
As discussed in Permit Application No. 9200349.12D, the worst case emissions of PM result from the firing of K-083 liquid waste in the boiler. The emission factor for this fuel is established as 0.021 pounds of PM per million Btu. Thus, no monitoring, recordkeeping, or reporting is required to ensure compliance for this rule. No changes to permit are needed under this permit modification.
15A NCAC 2D .0516, “Sulfur Dioxide Emissions from Combustion Sources” – Boiler BH-7 is subject to this rule because it combust fuels that contain sulfur compounds. The boiler is limited to a sulfur dioxide (SO2) emission rate of no more than 2.3 pounds SO2 per million Btu heat input.
As discussed in Permit Application No. 9200349.12D, the worst case emissions of SO2 result from the firing of K-083 liquid waste in the boiler. The emission factor for this fuel is established as 0.22 pounds of SO2 per million Btu. Thus, no monitoring, recordkeeping, or reporting is required to ensure compliance for this rule. No changes to permit are needed under this permit modification.
15A NCAC 2D .0521, “Control of Visible Emissions” – Visible emissions from boiler BH-7 shall not exceed 20% opacity when averaged over a six-minute period more than once in any hour and not more than four times in any 24-hour period. In no event shall the six-minute average exceed 87% opacity. Visible emissions are not expect from this boiler, and no monitoring, recordkeeping, or reporting is required to demonstrate compliance with this standard while firing natural gas and landfill gas. No changes to permit are needed under this permit modification.
15A NCAC 2D .0524, “New Source Performance Standards (NSPS)” – Boiler BH-7 is subject to the “NSPS for Small Industrial-Commercial-Institutional Steam Generating Units,” 40 CFR Part 60 Subpart Dc. More discussion of NSPS is provided in Section 7.
15A NCAC 2D .1100 “Control of Toxic Air Pollutants” – Boiler BH-7 was triggered into NC Air Toxics when it was added to the permit under Air Permit No. 01479T50 issued on September 10, 2012. More discussion of NC Air Toxics is provided in Section 7.
15A NCAC 2D .1111 “Maximum Achievable Control Technology (MACT)” – Boiler BH-7 burns hazardous waste and is subject to the “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE. More discussion of MACT is provided in Section 7.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 9 of 14
15A NCAC 2Q .0317, “Avoidance Conditions” – Mallinckrodt has accepted a facility-wide avoidance condition for 15A NCAC 2D .0530, Prevention of Significant Deterioration (PSD)” to limit emissions of nitrogen oxides (NOx) and SO2 to less than 100 tons per consecutive 12-month period. More discussion of PSD is provided in Section 7. 7. NSPS, NESHAPS/MACT, NSR/PSD, 112(r), CAM PSD Mallinckrodt is located in Wake County, which is currently designated as attainment or unclassified for all PSD regulated pollutants. The facility is a chemical processing plant, which is one of the 28 listed source categories with major source thresholds of 100 tons per consecutive 12-month period, under 40 CFR 51.166 (b)(1)(i)(a). Mallinckrodt has accepted avoidance conditions to limit emissions of NOx and SO2 to less than 100 tons per consecutive 12-month period to remain a minor source under PSD. This permit modification does not affect the PSD status of the facility, and no changes to the permit are needed. NSPS Mallinckrodt is subject to the following New Source Performance Standards. NSPS Subpart Dc The K-083 liquid waste/landfill gas/natural gas-fired boiler (ID No. BH-7: 66 million Btu per hour) and the natural gas/No. 2 fuel oil/landfill gas-fired boiler (ID No. BH-5: 96.2 million Btu per hour) are subject to the “NSPS for Small Industrial, Commercial, Institutional Steam Generating Units,” 40 CFR Part 60 Subpart Dc. This subpart applies to boilers that are constructed, modified, or reconstructed after June 9, 1989 and have a maximum design heat input capacity > 10 million Btu per hour and < 100 million Btu per hour. The requirements for boilers subject to NSPS Subpart Dc vary based on the size of the boiler and fuel type fired. Neither of the NSPS Subpart Dc boilers fires on wood or coal and, thus, neither of these boilers is subject to the particulate matter standards under this rule. Boiler BH-5, which fires on No. 2 fuel oil, is subject to the SO2 and visible emission standards as discussed below:
Sulfur Dioxide: The maximum sulfur content of any fuel oil received and fired in the boiler shall not exceed 0.5 percent by weight. To demonstrate compliance with this standard, Mallinckrodt is required to retain copies of each fuel supplier certification, including the sulfur content of the oil (in percent by weight). The facility is also required to submit a semiannual report summarizing the monitoring activities (January 30th and July 30th).
Visible Emissions: Under NSPS Subpart Dc, a boiler with a maximum heat input capacity of greater than or equal to 30 million Btu per hour shall not have visible emissions more than 20 percent opacity when averaged over a six-minute period, except for one six-minute period per hour of not more than 27 percent opacity. Oil-fired boilers subject to NSPS Subpart Dc have to conduct Method 9 VE observations at least once every 12 calendar months as per 40 CFR 63.47c (a). The VE monitoring schedule when firing on oil is determined by the actual visible emissions observed during previous testing. The facility has not fired oil since 2009, and the permit requires VE testing when the boiler again begins firing No. 2 fuel oil.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 10 of 14
Both boilers (ID Nos. BH-5 and BH-7) have to record monthly fuel usage as required under NSPS Subpart Dc. No other requirements apply under NSPS Subpart Dc when firing natural gas. This permit modification does not affect NSPS Subpart Dc requirements, and no changes to the permit are needed. NSPS Subpart VV Certain fugitive emission sources in Mallinckrodt’s chemical manufacturing process are subject to “Standards of Performance for Equipment Leaks of VOC in the Synthetic Organic Chemicals Manufacturing Industry for Which Construction, Reconstruction, or Modification Commenced After January 5, 1981, and on or Before November 7, 2006,” 40 CFR Part 60 Subpart VV. This permit modification does not affect the requirements under NSPS Subpart VV, and no changes to the permit are needed. NSPS Subpart NNN The acetaminophen production process (ID No. APAP-1) and process equipment listed in “Confidential Building 205 Equipment List” are subject to “Standards of Performance for Volatile Organic Compound (VOC) Emissions from Synthetic Organic Chemical Manufacturing Industry (SOCMI) Distillation Operations,” 40 CFR Part 60 Subpart NNN. This permit modification does not affect the requirements under NSPS Subpart NNN, and no changes to the permit are needed. MACT/GACT Mallinckrodt is subject to the following MACT/GACTs. MACT Subpart EEE Boilers BH-2 and BH-7 are permitted to fire K-083 liquid waste, which is an aniline tar liquid waste stream generated from the PAP manufacturing process. K-083 liquid waste also meets the definition of hazardous waste. By firing K-083 liquid waste, boilers BH-2 and BH-7 are subject to “National Emission Standards for Hazardous Air Pollutants: Final Standards for Hazardous Air Pollutants for Hazardous Waste Combustors,” 40 CFR Part 63 Subpart EEE. Both boilers are considered liquid fired boilers (LFB) under MACT EEE. As per 40 CFR 63.1206(a)(2)(ii)(A), a new emission source is one in which construction or reconstruction was commenced after April 20, 2004. Boiler BH-2 is considered an existing source and boiler BH-7 is a considered new source under MACT Subpart EEE based on this date. The requirements under MACT Subpart EEE are extensive. The facility has to meet emission limits for numerous pollutants, develop and implement a feed stream analysis plan, conduct initial and periodic comprehensive performance testing, meet operating limits, ensure operator testing and certification, and meet other monitoring, recordkeeping, and reporting requirements. The emission limits for LFB are based on the type of air pollution control system, the heat content of the hazardous waste2, and the HAP status of the facility. Area sources of HAPs are 2
The heat content of the K-083 liquid waste is greater than 10,000 Btu/lb, as discussed in the permit review for Air Permit No. 01479T46 (Fern Patterson, March 17, 2010).
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 11 of 14
subject to the standards for dioxin and furans (if applicable), mercury, carbon monoxide, and hydrocarbon. They are also subject to the destruction and removal efficiency (DRE) standards. As noted previously, area sources of HAPs are not subject to the cadmium and lead, chromium, hydrogen chloride and chlorine, and PM standards under MACT EEE. They comply with 40 CFR 266.105, 266.106, and 266.107 via their RCRA Part B permit for these pollutants. However, MACT Subpart EEE provides the option for area sources to comply with the elective standards for these pollutants under MACT EEE in lieu of the standards under 40 CFR 266.105, 266.106, and 266.107. A summary of the emission limits are provided in the table below. Emission Limits DRE Dioxin and Furans Mercury Carbon Monoxide Hydrocarbons
Boiler BH-2 (Existing LFB)
Boiler BH-7 (New LFB)
99.99 % 99.99 % Per 40 CFR 63.1217(a)(1)(ii) and (b)(1)(ii), sources not equipped with a dry air pollution control system comply with either the carbon monoxide or hydrocarbon in excess emission limits. 4.2E-05 lbs/MMBtu on an annual 1.2E-6 lbs/MM Btu on an annual averaging averaging period period 100 ppmdv, corrected to 7% oxygen, 100 ppmdv, corrected to 7% oxygen, on a on a rolling hourly average rolling hourly average 10 ppmdv, corrected to 7% oxygen, 10 ppmdv, corrected to 7% oxygen, on a on a rolling hourly average, reported rolling hourly average, reported as propane as propane
Hydrogen chloride and chlorine1
5.1E-02 lbs/MMBtu
Cadmium and Lead
8.2E-05 lbs/MMBtu on an annual averaging period2
Chromium
1.3E-04 lbs/MMBtu2
Particulate Matter
80 mg/dscm, corrected to 7% oxygen2
5.1E-02 lbs/MMBtu Mallinckrodt can elect to comply with the standards for cadmium, lead, chromium and particulate matter under 40 CFR 266.105 and 266.106 OR They can elect to comply with the following emission limits under 40 CFR 63.1217(b): Cadmium and lead, combined: 6.2E-06 lbs/MMBtu on an annual averaging period. Chromium: 1.4E-05 lbs/MMBtu. PM : 20 mg/dscm, corrected to 7% oxygen.
Notes: 1. Per 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3), Mallinckrodt can comply with the standards for hydrogen chloride and chlorine under 40 CFR 266.107 or they can comply with the emission limit under 40 CFR 63.1217. The facility has elected to comply with the MACT Subpart EEE emission limit for these HAPs for both boilers. 2. Per 40 CFR 63.1217(f) and 40 CFR 266.100(b)(3), Mallinckrodt can comply with the standards for cadmium, lead, chromium and particulate matter 40 CFR 266.105 and 40 CFR 266.106 or they can comply with the emission limits under 40 CFR 63.1217. The facility has elected to comply with the MACT Subpart EEE emission limit for these HAPs for boiler BH-2.
As discussed earlier, Mallinckrodt is electing to comply with standards for cadmium and lead, chromium, and PM in 40 CFR 266.105 and 266.106. The permit will be modified to specify both compliance options – MACT Subpart EEE or 40 CFR 266.105 and 266.106 – for cadmium and lead, chromium, and PM for boiler BH-7 under this permit modification.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 12 of 14
The permit condition for MACT Subpart EEE will also be “cleaned up” under this permit modification. One change to note in this cleanup involves the confirmatory performance test requirements under MACT Subpart EEE. As specified in 40 CFR 63.1207(b)(2), confirmatory performance tests are required to demonstrate compliance with the dioxin/furan emission standard. However in 40 CFR 63.12179(a)(i) and (b)(i), MACT Subpart EEE states the dioxin/furan standards are only applicable to facilities that use dry air pollution control systems. Facilities not equipped with a dry air pollution control system instead comply with the carbon monoxide or hydrocarbon emissions standards, per 40 CFR 63.12179(a)(ii) and (b)(ii). Mallinckrodt controls emissions from boilers BH-2 and BH-7 with a CCS, which is not a dry air pollution control system. Therefore, Mallinckrodt is not subject to the dioxin/furan standards, and confirmatory testing is not required. The confirmatory performance test requirements will be removed under this permit modification. GACT Subpart ZZZZ The diesel-fired fire pump (ID No. I-WW-6), the standby diesel generator (ID No. WW-1), and the No. 2 fuel oil-fired emergency generator (ID No. PAR-11) are subject to the “NESHAP for Stationary Reciprocating Internal Combustion Engines,” 40 CFR Part 63 Subpart ZZZZ. This modification does not affect these engines, and no change to the permit is needed. However, this permit condition will be updated at the next permit renewal. GACT Subpart CCCCCC The gasoline storage tank (ID No. GDF-1) is subject to the “NESHAP for Gasoline Dispensing Facilities,” or GACT Subpart CCCCCC. This modification does not affect this tank, and no change to the permit is needed. GACT Subpart JJJJJJ [Mallinckrodt] is classified as an area source of HAPs, and the boilers (ID Nos. B2, B3, B4, B5, B6, B8, and ES-A3-2-B7) are subject to the “NESHAP for Area Sources: Industrial, Commercial, and Institutional Boilers,” or GACT Subpart 6J. These boilers were constructed prior to June 4, 2010 and are considered to be existing boilers under this rule. Additionally, the boilers fall in the oil subcategory under the rule because they “[burn] any liquid fuel and [are] not in either the biomass or coal subcategories.” Although they also fire on natural gas, they do not meet naturalgas exemptions under GACT Subpart 6J. The boilers are subject to work practice standards, including an initial tune-up, which was due no later than March 21, 2014. Additional tune-ups are due biennially. The natural gas-fired hot oil heaters (ID No. IB7 and IB8) are NOT subject to GACT 6J because the definition of boiler explicitly excludes process heaters, such as oil heaters. Per the definition under 40 CFR 63.11237, “Process heaters include units that heat water/water mixtures for pool heating, sidewalk heating, cooling tower water heating, power washing, or oil heating.” This permit modification does not affect these boilers or the facility’s status with respect to GACT Subpart JJJJJJ. Changes were made to update the permit with the most current permitting language under this permit renewal. 112(r)
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 13 of 14
The facility is subject to Section 112(r) of the Clean Air Act requirements because it stores anhydrous ammonia in quantities above the threshold quantity in the Rule. This permit modification does not affect the 112(r) status, and no changes to the permit are needed. However, this permit condition will be updated at the next permit renewal. CAM Mallinckrodt is not subject to 40 CFR Part 64 CAM, and this permit modification does not affect the CAM status. 8. Facility Wide Air Toxics Mallinckrodt has existing emissions limitations for several toxic air pollutants (TAPs) based on previously submitted compliance demonstrations consistent with the requirements in 15A NCAC 2D .1100. This permit modification does not affect the status with respect to 2D .1100, and no changes to the permit are needed. Additionally, Mallinckrodt has previously demonstrated that the TAPs listed in Section 2.2.A.3 of the permit are below their Toxics Permitting Emission Rate, in accordance with 2Q .0711. This permit modification does not affect the status with respect to 2Q .0711, and no changes to the permit are needed. 9. Facility Emissions Review There is no change in Title V potential emissions under this permit modification. Actual emissions for 2010 through 2014 are reported in the header of this permit review. Additionally, the permit application submitted on May 11, 2015 indicated that Mallinckrodt has potential emissions of 173,488 metric tons of CO2 equivalents.3 10. Compliance Status The most recent compliance inspection was conducted on September 14, 2014 by Will Wike of the RRO. The facility appeared to be in compliance with all applicable requirements at that time. 11. Other Regulatory Considerations
A P.E. seal is required for this application and was provided in the permit application submitted on May 11, 2015. A zoning consistency determination is NOT required for this application. A permit application fee of $918 is required and was submitted with the permit application.
12. Recommendations The permit modification application for Mallinckrodt - Raleigh Pharmaceutical Plant located in Raleigh, Wake County, NC has been reviewed by DAQ to determine compliance with all procedures 3
CO2 equivalent is defined as the sum of individual greenhouse gas pollutant emission times their global warming potential, converted to metric tons.
Attachment 2, cont., to review of application 9200349.16A T53 Permit Review Mallinckrodt - Raleigh Pharmaceutical Plant Page 2 of 14
and requirements. DAQ has determined that this facility is complying or will achieve compliance, as specified in the permit, with all requirements that are applicable to the affected sources. The DAQ recommends the issuance of Air Permit No. 01479T53, requiring the submittal of a TV permit application within one-year of permit issuance.
Attachment 3 to review of application 9200349.16A Mallinckrodt - Raleigh Pharmaceutical Plant
Comments on Initial Drafts
Will Wike, by phonecall on August 18, 2016 The T53 permit review attached to the draft contains information that is no longer relevant or correct. The facility has undergone some changes since this review was published. Should it still be included in this current review? Response: With the 2-step process, we always include the original 1st step review as an attachment. It may no longer be current, but it contains the information originally used to modify the permit.
Will Wike, by email on August 18, 2016 1. There is a typo in the T53 permit review. At one point it refers to "Akzo Nobel" instead of Mallinckrodt. Response: I have corrected this typo. 2. The permitted emission source list has an asterisk associated with BH-7 that should be removed. Response: Fixed.
Mark Cuilla, by email on August 19, 2016 1. The draft review has the dates of emission testing and the issuance of permit T53 in the wrong order. Response: Fixed. 2. Mark pointed out typos in the review and permit. Response: Fixed. 3. Mark suggested that Paragraph 2.1.D.5.j.ix. not be removed. Response: After speaking with Mark, I agree that this paragraph should remain in the permit. It has been changed to reflect Mallinckrodt's choice to use 40 CFR 266.105 and .106.
Charles McEachern, by email on August 24, 2016 Charles asked that the review have a better explanation for why this permit application is necessary. It should discuss the Part I and II requirements. Response: I have added this to the review discussion.
