1. THE PROPOSAL
  2. MOTIONS
  3. DISCUSSION
        1. Section 218.480 Applicability

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ILLINOIS POLLUTION CONTROL BOARD
October 4, 2007
 
IN THE MATTER OF:
 
ABBOTT LABORATORIES’ PROPOSED SITE SPECIFIC AMENDMENT TO APPLICABILITY SECTION OF ORGANIC MATERIAL EMISSION STANDARDS AND LIMITATIONS FOR THE CHICAGO AREA; SUBPART T: PHARMACEUTICAL MANUFACTURING (35 ILL. ADM. CODE 218.480(b)) 		)
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R08-8
(Rulemaking -Air)

Proposed Rule. First Notice.
 
OPINION AND ORDER OF THE BOARD (by N. J. Melas):
 
  On September 4, 2007, Abbott Laboratories (Abbott) filed a proposal for site-specific rulemaking pursuant to Section 28 of Environmental Protection Act (Act) (415 ILCS 28 (2006)), to allow it “additional operational flexibility” with regard to emissions from certain tunnel dryers and fluid bed dryers at its pharmaceutical manufacturing facility located in Libertyville Township, Lake County. Abbott also filed motions requesting the Board to waive the requirement for 200 signatures on its petition and to expedite consideration of its request by, among other things, ordering immediate publication of the rules for first notice under the Illinois Administrative Procedure Act (APA) (5 ILCS 100/1-1)(2006). See, respectively, 35 Ill. Adm. Code Sections 102.202(g) and 101.512. To date, the Board has received no response to either motion from the Illinois Environmental Protection Agency (Agency) or any other person.
 
 In this order, the Board accepts the proposal for hearing, granting the motion to waive signature requirement. The Board denies the motion for expedited consideration, but authorizes first-notice publication of the proposal without comment on the proposal’s merits.
 

THE PROPOSAL

 
Abbott owns a pharmaceutical manufacturing facility located in Libertyville Township, Lake County, Illinois (“the Facility”). Abbott’s operations are subject to 35 Ill. Adm. Code, Subpart T – Pharmaceutical Manufacturing (“Subpart T”). As currently written, Subpart T, Section 218.480(b) (“Section 218.480(b)”) contains certain exemptions that are only applicable to Abbott’s air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located at the Facility. Abbott is proposing to amend these site-specific exemptions by “capping” and lowering the overall emissions allowable under the exemptions from its tunnel dryers numbered #1, #2, #3 and #4, and fluid bed dryers numbered #1, #2 and #3, and calculating the amount of exempted emissions from the dryers based on the actual combined emissions from the dryers. Abbott believes that, if adopted, the proposed amendment would reduce the overall allowable emissions from these units while increasing Abbott’s operational flexibility, by allowing it to make preferential use of the more efficient fluid bed dryers.
 

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MOTIONS
 

Abbott first requests that the Board waive the requirement for 200 signatures on the petition, as required by 35 Ill. Adm. Code Section 102.202(g). In support of this motion, Abbott cites various past proceedings in which the Board has granted similar requests.
 
In its motion to expedite (Mot. Exp.),Abbott also requests that the Board proceed to APA first notice without reaching a decision on the merits, by accepting the regulatory language proposed by Abbott in this rulemaking proposal only for purposes of first notice. Abbott also requests that the requisite hearing be scheduled as soon as possible in accordance with Section 28(a) of the Act. Mot. Exp. at 2-3.
 
 In support of this request, Abbott asserts that the proposal is intended to increase efficiency in its use of certain fluidized bed and tunnel dryers while providing for lower allowable emissions from these dryers as a group. Abbot contends that the current rule “requires Abbott to utilize its equipment and resources in a manner that is inefficient . . . [causing] material prejudice to Abbott.” Mot. Exp. at 2. Abbott states that the Agency has been contacted and has no disagreement with the proposed amendments. Abbott also cites to other proceedings in which the Board has granted similar requests. Abbott also states that if more information is needed that it will expeditiously provide it. Id. at 3.
 

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DISCUSSION
 

First, the Board finds that the petition meets the content requirements of 35 Ill. Adm. Code 102.208 and 102.210 and is accepted for hearing. However, a review of the proposal reveals that Abbott did not address the applicability of, or provide the information requested in, the “published study or report” requirement of Section 102.210(c). 35 Ill. Adm. Code 102.210(c); see also 35 Ill. Adm. Code 102.210(g). The Board requests that Abbott address Section 102.210(c), or its inapplicability, in writing, prior to any hearing scheduled in this proceeding or at such other time as directed by the hearing officer.
 
Next, the Board grants the motion to waive the signature requirement of Section 102.202(g).
 
Lastly, the Board denies the motion for expedited consideration. Requests for expedited review are governed by Section 101.512 of the Board's rules, and must contain, inter alia, a complete statement of the facts and reasons for the request. See 35 Ill. Adm. Code 101.512. In acting on a motion for expedited review, the Board considers, at a minimum, all statutory requirements and whether or not material prejudice will result from the motion being granted or denied. 35 Ill. Adm. Code 101.512(b). In addition, the Board will only grant a motion for expedited review consistent with available resources. See 35 Ill. Adm. Code 101.512(c).
 
The Board does not discount Abbott’s assertions that continued operations using less efficient drying processes is not optimal, and for the purposes of this motion accepts as true Abbott’s assertions that actual emissions would be lowered if it operates under an amended rule as proposed. However, this does not give rise to “material prejudice” sufficient to allow the Board to grant Abbott’s request as made.
 
As noted, expedited review is granted consistent with decision deadlines and available resources. The Board currently has numerous open rulemaking dockets that demand immediate attention, as well as pressing cases that will keep the Board busy for several months.
 
Due to attrition, Board staffing is at its lowest levels in some years. Even if the Board were to accept that Abbott’s claims amount to “material prejudice”, the Board’s limited resources in light of its current and future decision deadlines render the granting of a motion for expedited review unlikely in all but the most dire circumstances.
 
However, the Board can authorize the first-notice publication of this proposal without comment on its merits. The Board notes that it has made minor, non-substantive changes to the text of the proposed rule. The Board directs its hearing officer to expeditiously schedule hearing consistent with the Board’s decision calendar and operational needs.
 
 The Board directs the Clerk to cause first-notice publication in the Illinois Register of the following proposed rule:
 

TITLE 35: ENVIRONMENTAL PROTECTION
SUBTITLE B: AIR POLLUTION
CHAPTER I: POLLUTION CONTROL BOARD
SUBCHAPTER c: EMISSIONS STANDARDS AND
LIMITATIONS FOR STATIONARY SOURCES
 
PART 218
ORGANIC MATERIAL EMISSION STANDARDS AND
LIMITATIONS FOR THE CHICAGO AREA
 
 
SUBPART A: GENERAL PROVISIONS

Section

 
218.100 Introduction
218.101 Savings Clause
218.102 Abbreviations and Conversion Factors
218.103 Applicability
218.104 Definitions
218.105 Test Methods and Procedures
218.106 Compliance Dates
218.107 Operation of Afterburners
218.108 Exemptions, Variations, and Alternative Means of Control or Compliance Determinations
218.109 Vapor Pressure of Volatile Organic Liquids
218.110 Vapor Pressure of Organic Material or Solvent
218.111 Vapor Pressure of Volatile Organic Material
218.112 Incorporations by Reference
218.113 Monitoring for Negligibly-Reactive Compounds
218.114 Compliance with Permit Conditions

SUBPART B: ORGANIC EMISSIONS FROM STORAGE AND LOADING OPERATIONS

Section

 
218.119 Applicability for VOL
218.120 Control Requirements for Storage Containers of VOL
218.121 Storage Containers of VPL
218.122 Loading Operations
218.123 Petroleum Liquid Storage Tanks
218.124 External Floating Roofs
218.125 Compliance Dates
218.126 Compliance Plan (Repealed)
218.127 Testing VOL Operations
218.128 Monitoring VOL Operations
218.129 Recordkeeping and Reporting for VOL Operations

SUBPART C: ORGANIC EMISSIONS FROM MISCELLANEOUS EQUIPMENT

Section

 
218.141 Separation Operations
218.142 Pumps and Compressors
218.143 Vapor Blowdown
218.144 Safety Relief Valves

SUBPART E: SOLVENT CLEANING

Section

 
218.181 Solvent Cleaning in General
218.182 Cold Cleaning
218.183 Open Top Vapor Degreasing
218.184 Conveyorized Degreasing
218.185 Compliance Schedule (Repealed)
218.186 Test Methods

SUBPART F: COATING OPERATIONS

Section

218.204 Emission Limitations
218.205 Daily-Weighted Average Limitations
218.206 Solids Basis Calculation
218.207 Alternative Emission Limitations
218.208 Exemptions from Emission Limitations
218.209 Exemption from General Rule on Use of Organic Material
218.210 Compliance Schedule
218.211 Recordkeeping and Reporting
218.212 Cross-Line Averaging to Establish Compliance for Coating Lines
218.213 Recordkeeping and Reporting for Cross-Line Averaging Participating Coating Lines
218.214 Changing Compliance Methods

218.215  Wood Furniture Coating Averaging Approach
218.216  Wood Furniture Coating Add-On Control Use
218.217  Wood Furniture Coating Work Practice Standards
 

SUBPART G: USE OF ORGANIC MATERIAL

Section

 
218.301 Use of Organic Material
218.302 Alternative Standard
218.303 Fuel Combustion Emission Units
218.304 Operations with Compliance Program

SUBPART H: PRINTING AND PUBLISHING

Section

 
218.401 Flexographic and Rotogravure Printing
218.402 Applicability
218.403 Compliance Schedule
218.404 Recordkeeping and Reporting
218.405 Lithographic Printing: Applicability
218.406 Provisions Applying to Heatset Web Offset Lithographic Printing Prior to March 15, 1996
218.407 Emission Limitations and Control Requirements for Lithographic Printing Lines On and After March 15, 1996
218.408 Compliance Schedule for Lithographic Printing On and After March 15, 1996
218.409 Testing for Lithographic Printing On and After March 15, 1996
218.410 Monitoring Requirements for Lithographic Printing
218.411 Recordkeeping and Reporting for Lithographic Printing

SUBPART Q: SYNTHETIC ORGANIC CHEMICAL AND POLYMER MANUFACTURING PLANT

Section

 
218.421 General Requirements
218.422 Inspection Program Plan for Leaks
218.423 Inspection Program for Leaks
218.424 Repairing Leaks
218.425 Recordkeeping for Leaks
218.426 Report for Leaks
218.427 Alternative Program for Leaks
218.428 Open-Ended Valves
218.429 Standards for Control Devices
218.430 Compliance Date (Repealed)
218.431 Applicability
218.432 Control Requirements
218.433 Performance and Testing Requirements
218.434 Monitoring Requirements
218.435 Recordkeeping and Reporting Requirements
218.436 Compliance Date

SUBPART R: PETROLEUM REFINING AND RELATED INDUSTRIES; ASPHALT MATERIALS

Section

 
218.441 Petroleum Refinery Waste Gas Disposal
218.442 Vacuum Producing Systems
218.443 Wastewater (Oil/Water) Separator
218.444 Process Unit Turnarounds
218.445 Leaks: General Requirements
218.446 Monitoring Program Plan for Leaks
218.447 Monitoring Program for Leaks
218.448 Recordkeeping for Leaks
218.449 Reporting for Leaks
218.450 Alternative Program for Leaks
218.451 Sealing Device Requirements
218.452 Compliance Schedule for Leaks
218.453 Compliance Dates (Repealed)

SUBPART S: RUBBER AND MISCELLANEOUS PLASTIC PRODUCTS

Section

 
218.461 Manufacture of Pneumatic Rubber Tires
218.462 Green Tire Spraying Operations
218.463 Alternative Emission Reduction Systems
218.464 Emission Testing
218.465 Compliance Dates (Repealed)
218.466 Compliance Plan (Repealed)

SUBPART T: PHARMACEUTICAL MANUFACTURING

Section

 
218.480 Applicability
218.481 Control of Reactors, Distillation Units, Crystallizers, Centrifuges and Vacuum Dryers
218.482 Control of Air Dryers, Production Equipment Exhaust Systems and Filters
218.483 Material Storage and Transfer
218.484 In-Process Tanks
218.485 Leaks
218.486 Other Emission Units
218.487 Testing
218.488 Monitoring for Air Pollution Control Equipment
218.489 Recordkeeping for Air Pollution Control Equipment

SUBPART V: BATCH OPERATIONS AND AIR OXIDATION PROCESSES

Section

 
218.500 Applicability for Batch Operations
218.501 Control Requirements for Batch Operations
218.502 Determination of Uncontrolled Total Annual Mass Emissions and Average Flow Rate Values for Batch Operations
218.503 Performance and Testing Requirements for Batch Operations
218.504 Monitoring Requirements for Batch Operations
218.505 Reporting and Recordkeeping for Batch Operations
218.506 Compliance Date
218.520 Emission Limitations for Air Oxidation Processes
218.521 Definitions (Repealed)
218.522 Savings Clause
218.523 Compliance
218.524 Determination of Applicability
218.525 Emission Limitations for Air Oxidation Processes
218.526 Testing and Monitoring
218.527 Compliance Date (Repealed)

SUBPART W: AGRICULTURE

Section

 
218.541 Pesticide Exception

SUBPART X: CONSTRUCTION

Section

 
218.561 Architectural Coatings
218.562 Paving Operations
218.563 Cutback Asphalt

SUBPART Y: GASOLINE DISTRIBUTION

Section

 
218.581 Bulk Gasoline Plants
218.582 Bulk Gasoline Terminals
218.583 Gasoline Dispensing Operations - Storage Tank Filling Operations
218.584 Gasoline Delivery Vessels
218.585 Gasoline Volatility Standards
218.586 Gasoline Dispensing Operations - Motor Vehicle Fueling Operations

SUBPART Z: DRY CLEANERS

Section

 
218.601 Perchloroethylene Dry Cleaners (Repealed)
218.602 Applicability (Repealed)
218.603 Leaks (Repealed)
218.604 Compliance Dates (Repealed)
218.605 Compliance Plan (Repealed)
218.606 Exception to Compliance Plan (Repealed)
218.607 Standards for Petroleum Solvent Dry Cleaners
218.608 Operating Practices for Petroleum Solvent Dry Cleaners
218.609 Program for Inspection and Repair of Leaks
218.610 Testing and Monitoring
218.611 Applicability for Petroleum Solvent Dry Cleaners
218.612 Compliance Dates (Repealed)
218.613 Compliance Plan (Repealed)

SUBPART AA: PAINT AND INK MANUFACTURING

Section

 
218.620 Applicability
218.621 Exemption for Waterbase Material and Heatset Offset Ink
218.623 Permit Conditions (Repealed)
218.624 Open Top Mills, Tanks, Vats or Vessels
218.625 Grinding Mills
218.626 Storage Tanks
218.628 Leaks
218.630 Clean Up
218.636 Compliance Schedule
218.637 Recordkeeping and Reporting

SUBPART BB: POLYSTYRENE PLANTS

Section

 
218.640 Applicability
218.642 Emissions Limitation at Polystyrene Plants
218.644 Emissions Testing

SUBPART CC: POLYESTER RESIN PRODUCT MANUFACTURING PROCESS

Section

 
218.660 Applicability
218.666 Control Requirements
218.667 Compliance Schedule
218.668 Testing
218.670 Recordkeeping and Reporting for Exempt Emission Units
218.672 Recordkeeping and Reporting for Subject Emission Units

SUBPART DD: AEROSOL CAN FILLING

Section

 
218.680 Applicability
218.686 Control Requirements
218.688 Testing
218.690 Recordkeeping and Reporting for Exempt Emission Units
218.692 Recordkeeping and Reporting for Subject Emission Units

SUBPART FF: BAKERY OVENS (REPEALED)

Section

 
218.720 Applicability (Repealed)
218.722 Control Requirements (Repealed)
218.726 Testing (Repealed)
218.727 Monitoring (Repealed)
218.728 Recordkeeping and Reporting (Repealed)
218.729 Compliance Date (Repealed)
218.730 Certification (Repealed)

SUBPART GG: MARINE TERMINALS

Section

 
218.760 Applicability
218.762 Control Requirements
218.764 Compliance Certification
218.766 Leaks
218.768 Testing and Monitoring
218.770 Recordkeeping and Reporting

SUBPART HH: MOTOR VEHICLE REFINISHING

Section

 
218.780 Emission Limitations
218.782 Alternative Control Requirements
218.784 Equipment Specifications
218.786 Surface Preparation Materials
218.787 Work Practices
218.788 Testing
218.789 Monitoring and Recordkeeping for Control Devices
218.790 General Recordkeeping and Reporting (Repealed)
218.791 Compliance Date
218.792 Registration
218.875 Applicability of Subpart BB (Renumbered)
218.877 Emissions Limitation at Polystyrene Plants (Renumbered)
218.879 Compliance Date (Repealed)
218.881 Compliance Plan (Repealed)
218.883 Special Requirements for Compliance Plan (Repealed)
218.886 Emissions Testing (Renumbered)

SUBPART PP: MISCELLANEOUS FABRICATED PRODUCT MANUFACTURING PROCESSES

Section

218.920 Applicability
218.923 Permit Conditions (Repealed)
218.926 Control Requirements
218.927 Compliance Schedule
218.928 Testing

218.929  Cementable and Dress or Performance Shoe Leather
 

SUBPART QQ: MISCELLANEOUS FORMULATION MANUFACTURING PROCESSES

Section

 
218.940 Applicability
218.943 Permit Conditions (Repealed)
218.946 Control Requirements
218.947 Compliance Schedule
218.948 Testing

SUBPART RR: MISCELLANEOUS ORGANIC CHEMICAL MANUFACTURING PROCESSES

Section

 
218.960 Applicability
218.963 Permit Conditions (Repealed)
218.966 Control Requirements
218.967 Compliance Schedule
218.968 Testing

SUBPART TT: OTHER EMISSION UNITS

Section

 
218.980 Applicability
218.983 Permit Conditions (Repealed)
218.986 Control Requirements
218.987 Compliance Schedule
218.988 Testing

SUBPART UU: RECORDKEEPING AND REPORTING

Section

 
218.990 Exempt Emission Units
218.991 Subject Emission Units
218.APPENDIX A: List of Chemicals Defining Synthetic Organic Chemical and Polymer Manufacturing
218.APPENDIX B: VOM Measurement Techniques for Capture Efficiency (Repealed)
218.APPENDIX C:
Reference Methods and Procedures
218.APPENDIX D: Coefficients for the Total Resource Effectiveness Index (TRE) Equation
218.APPENDIX E:
List of Affected Marine Terminals
 
218.APPENDIX G: TRE Index Measurements for SOCMI Reactors and Distillation Units
218.APPENDIX H: Baseline VOM Content Limitations for Subpart F, Section 218.212 Cross-Line Averaging

AUTHORITY: Implementing Section 10 and authorized by Sections 27, 28, 28.5 of the Environmental Protection Act [415 ILCS 5/10 and 28.5].
 
SOURCE: Adopted at R91-7 at 15 Ill. Reg. 12231, effective August 16, 1991; amended in R91-24 at 16 Ill. Reg. 13564, effective August 24, 1992; amended in R91-28 and R91-30 at 16 Ill. Reg. 13864, effective August 24, 1992; amended in R93-9 at 17 Ill. Reg. 16636, effective September 27, 1993; amended in R93-14 at 18 Ill. Reg. at 1945, effective January 24, 1994; amended in R94-12 at 18 Ill. Reg. 14973, effective September 21, 1994; amended in R94-15 at 18 Ill. Reg. 16392, effective October 25, 1994; amended in R94-16 at 18 Ill. Reg. 16950, effective November 15, 1994; amended in R94-21, R94-31 and R94-32 at 19 Ill. Reg. 6848, effective May 9, 1995; amended in R94-33 at 19 Ill. Reg. 7359, effective May 22, 1995; amended in R96-13 at 20 Ill. Reg. 14428, effective October 17, 1996; amended in R97-24 at 21 Ill. Reg. 7708, effective June 9, 1997; amended in R97-31 at 22 Ill. Reg. 3556, effective February 2, 1998; amended in R98-16 at 22 Ill. Reg. 14282, effective July 16, 1998; amended in R02-20 at 27 Ill. Reg. 7283, effective April 8, 2003; amended in R04-12/20 at 30 Ill. Reg. 9684, effective May 15, 2006; amended in R06-21 at 31 Ill. Reg. 7086, effective April 30, 2007; amended in R08-8 at 31 Ill. Reg. ___________, effective _______________.
 
 

SUBPART T: PHARMACEUTICAL MANUFACTURING
 

 



Section 218.480  Applicability
 

  
a) The rules of this Subpart, except for Sections 218.483 through 218.485 of this Part, apply to all emission units of VOM, including but not limited to reactors, distillation units, dryers, storage tanks for VOL, equipment for the transfer of VOL, filters, crystallizers, washers, laboratory hoods, pharmaceutical coating operations, mixing operations and centrifuges used in manufacturing, including packaging, of pharmaceuticals, and emitting more than 6.8 kg/day (15 lbs/day) and more than 2,268 kg/year (2.5 tons/year) of VOM. If such an emission unit emits less than 2,268 kg/year (2.5 tons/year) of VOM, the requirements of this Subpart still apply to the emission unit if VOM emissions from the emission unit exceed 45.4 kg/day (100 lbs/day).
b) Notwithstanding subsection (a) of this Section, the air suspension coater/dryer, fluid bed dryers, tunnel dryers, and Accelacotas located in Libertyville Township, Lake County, Illinois shall be exempt from the rules of this Subpart, except for Sections 218.483 through 218.485, if emissions of VOM not vented to air pollution control equipment do not exceed the following levels:
     
1) For the air suspension coater/dryer: 2,268 kg/year (2.5 tons/year);
2) Except as set forth in subsection 218.480(b)(4) of this Section, for For each fluid bed dryer: 4,535 kg/year (5.0 tons/year);
3) Except as set forth in subsection 218.480(b)(4) of this Section, for For each tunnel dryer: 6,803 kg/year (7.5 tons/year); and
4) For fluid bed dryers #1, #2, and #3 and for tunnel dryers #1, #2, #3, and #4, the combined total annual emissions from the dryers listed in this subsection 218.480(b)(4) shall not exceed 18,779 kg/year (20.7 tons/year). [BOARD NOTE: tunnel dryers are otherwise referred to as warm air dryers]; and
45) For each Accelacota: 6,803 kg/year (7.5 tons/year).
 
c) Sections 218.483 through 218.485 of this Part apply to a source having one or more emission units that:
  
1) Are used to manufacture pharmaceuticals, and
2) Emit more than 6.8 kg/day (15 lbs/day) of VOM and more than 2,268 kg/year (2.5 tons/year) of VOM, or, if less than 2,268 kg/year (2.5 tons/year), these Sections still apply if emissions from one or more sources exceed 45.4 kg/day (100 lbs/day).
      
d) No owner or operator shall violate any condition in a permit when the condition results in exclusion of an emission unit from this Subpart.
e) Any pharmaceutical manufacturing source that becomes subject to the provisions of this Subpart at any time shall remain subject to the provisions of this Subpart at all times.
f) Emissions subject to this Subpart shall be controlled at all times consistent with the requirements set forth in this Subpart.
g) Any control device required pursuant to this Subpart shall be operated at all times when the source it is controlling is operated.
h) Determinations of daily and annual emissions for purposes of this Section shall be made using both data on the hourly emission rate (or the emissions per unit of throughput) and appropriate daily and annual data from records of emission unit operation (or material throughput or material consumption data). In the absence of representative test data pursuant to Section 218.487 of this Part for the hourly emission rate (or the emissions per unit of throughput) such items shall be calculated using engineering calculations, including the methods described in Appendix B of "Control of Volatile Organic Emissions from Manufacturing of Synthesized Pharmaceutical Products" (EPA-450/2-78-029), incorporated by reference in Section 218.112 of this Part. (This subsection shall not affect the Agency's or the USEPA's authority to require emission tests to be performed pursuant to Section 218.487 of this Part.)
i) Equipment and operations emitting VOM at a source subject to subsection (a) or (c) of this Section and used to produce pharmaceutical products or a pharmaceutical-like product such as a hormone, enzyme, or antibiotic, shall be deemed to be engaged in the manufacture of pharmaceuticals for the purposes of this Subpart.

(Source: Amended at 31 Ill. Reg. __________, effective ___________)
 
IT IS SO ORDERED.
 
Member A. S. Moore abstained.
 
I, John T. Therriault, Assistant Clerk of the Illinois Pollution Control Board, certify that the Board adopted the above order on October 4, 2007, by a vote of 3-0.
 
___________________________________
John T. Therriault, Assistant Clerk
Illinois Pollution Control Board
 
 
 
 
 
 
 
 

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