WQ0010607_Final Permit_20070913

Michael F. Easley, Governor
William G. Ross Jr., Secretary
North Carolina Departrnent of Environment and Natural Resources
Coleen H. Sullins, Director
Division of Water Quality
September 13, 2007
Dina Kostalcis, General Manager
Catalent Pharma Solutions, LLC
2725 Scherer Drive North
St. Petersburg, FL 33716-1016
Subject: Permit No. WQ0010607
Ownership Change from Cardinal Health PTS,
LLC to Catalent Pharma Solutions, LLC
Chelsea Labs Facility, Monroe,NC
Groundwater Remediation Facilities
Union County
Dear Ms. Kostalcis:
In accordance with your request for an ownership change from Cardinal Health PTS, LLC to Catalent
Phamla Solutions, LLC received August 1, 2007, and subsequent additional information received September 5,
2007, we are forwarding herewith Permit No. WQ0010607, dated September 13, 2007, to Catalent Pharma
Solutions, LLC for the continued operation of the subject groundwater remediation facility.
This permit shall be effective from the date of issuance until November 30, 2009, shall void Permit No.
WQ0010607 issued to Cardinal Health PTS, LLC on December 10, 2004, and shall be subject to the conditions and
limitations as specified therein. Please pay particular attention to the monitoring requirements in this permit.
Failure to establish an adequate system for collecting and maintaining the required operational 'information will
result in future compliance problems.
If any parts, requirements, or limitations contained in this permit are unacceptable, you have the right to
request an adjudicatory hearing upon written request within thirty (30) days following receipt of this permit. This
request must be in the form of a written petition, conforming to Chapter 150B of the North Carolina General
Statutes, and filed with the Office of Administrative Hearings, 6714 Mail Service Center, Raleigh, NC 27699-6714.
Unless such demands are made this permit shall be final and binding.
6162.
If you need any additional information concerning this matter, please contact David Goodrich at (919) 715 -
Sincerely,
St i for Coleen H. Sullins
cc: Union County Health Department
Mooresville Regional Office, Aquifer Protection Section
Rogers & Callcott, POBox 5655, Greenville, SC 29606, George Maalouf, P.G.
Technical Assistance and Certification Unit
Aquifer Protection — Central Files
tAPS Files '%
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Aquifer Protection Section 1636 Mail Service Center Raleigh, NC 27699-1636 Telephone: [phone]
Internet: httpl/h2o.enr.state.nc.us 2728 Capital Boulevard Raleigh, NC 27604 Fax 1: [phone]
Fax 2: [phone]
An Equal Opportunity/Affirmative Action Employer- 50%Recycled/10% Post Consumer Paper Customer Service: [phone]

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NORTH CAROLINA
ENVIRONMENTAL MANAGEMENT COMMISSION
DEPARTMENT OF ENVIRONMENT AND NATURAL RESOURCES
GROUNDWATER REMEDIATION PERMIT
In accordance with the provisions of Article 21 of Chapter 143, General Statutes of North Carolina as amended,
and other applicable Laws, Rules, and Regulations
PERMISSION IS HEREBY GRANTED TO
Catalent Pharma Solutions, LLC
Union County
FOR THE
continued operation of a 17,280 GPD groundwater remediation facility consisting of four (4) recovery wells (RW -
1, RW -2, RW -3 and RW -4 identified as MW -2, MW -3, MW -4 and MW -5, respectively, as shown on the attached
Layout of Monitoring Wells), a 50 GPM low profile tray type Air Striping Unit, 1,400 gallon Gravity Settling
Chamber, finished water pumping station with duplex submersible pumps, a 160' by 6' by 2' infiltration gallery,
and all necessary piping, valves, electrical fixtures and appurtenances required for proper operation pursuant to
the application received October 7, 2004, subsequent additional information received by the Division of Water
Quality (Division) on November 1, 2004, a Permit Name/Ownership Change Form received August 1, 2007, and
in conformity with the project plan, specifications, and other supporting data subsequently filed and approved by
the Division and considered a part of this permit.
This permit shall be effective from the date of issuance until November 30, 2009, shall void Permit No.
WQ0010607 issued December 10, 2004, and shall be subject to the following specified conditions and limitations:
I. PERFORMANCESTANDARDS
The groundwater treatment system shall consistently achieve at least 95% removal of the influent
contaminants or 15A NCAC 2L Section .0202(g) Class GA Standards (whichever is higher) prior to
discharge to the infiltration gallery. The treated water discharged into the infiltration gallery must not
cause a violation of Class GA Standards for any constituent beyond the Compliance Boundary, nor cause
the migration of the contamination into unaffected areas. If the treatment system fails to consistently
achieve this standard, additional treatment units or changes in operational needs may be required.
2. This permit shall become voidable if the soils fail to adequately assimilate the remaining wastes and may
be rescinded unless the facilities are installed, maintained, and operated in a manner, which will protect
the assigned water quality standards of the surface and groundwaters.
The issuance of this permit shall not relieve Catalent Pharma Solutions, LLC of the responsibility for
damages to surface or groundwaters resulting from the operation of this facility.
4. Any residuals generated from these treatment facilities must be disposed in accordance with General
Statute 143-215.1 and in a manner approved by the Division.
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5. Diversion or bypassing of the untreated groundwater from the treatment facilities is prohibited.
El. OPERATION AND MAINTENANCE REQUIREMENTS
The facilities shall be properly maintained and operated as a non -discharge system to prevent the
discharge of any wastewater resulting from the operation of this facility. The groundwater recovery,
treatment and disposal system shall be inspected weekly. If it is determined that the system is
malfunctioning or leading to the release of wastes to the environment, a threat to human health, or a
nuisance, all repairs should be made as soon as possible and reported to the Mooresville Regional Office
(see Section V. NONCOMPLIANCE NOTIFICATION). All components of the groundwater recovery,
treatment, and disposal system shall be properly weather -proofed to prevent freezing and failure of the
system.
2. Upon classification of the wastewater treatment and remediation facilities by the Water Pollution Control
System Operators Certification Commission (WPCSOCC), Catalent Pharma Solutions, LLC shall
designate and employ a certified operator to be in responsible charge (ORC) and one or more certified
operator(s) to be back-up ORC(s) of the facilities in accordance with 15A NCAC 8G .0201. The ORC
shall visit the facilities in accordance with 15A NCAC 8G .0204 or as specified in this permit and shall
comply with all other conditions specified in these rules.
3. The infiltration gallery shall be operated above the water table at all times.
4. If requested by the owner, the Division will consider remote monitoring in lieu of weekly physical
inspections, on a case-by-case basis, following at least two years of successful operation.
5. Catalent Pharma Solutions, LLC shall maintain an inspection log or summary including at least the date
and time of inspection, observations made, and any maintenance, repairs, or corrective actions taken by
Catalent Pharma Solutions, LLC. This log of inspections shall be maintained by Catalent Pharma
Solutions, LLC for a period of three years from the date of the inspection and shall be made available to
the Division or other permitting authority, upon request.
6. Any duly authorized officer, employee, or representative of the Division may, upon presentation of
credentials, enter and inspect any property, premises or place on or related to the disposal site or facility at
any reasonable time for the purpose of determining compliance with this permit, may inspect or copy any
records that must be maintained under the terms and conditions of this permit, and may obtain samples of
groundwater, surface water, or leachate.
1. When the system is operating, the influent and effluent for the treatment system shall be sampled at start
up and monthly thereafter for the parameters specified below:
EPA Method 621OD or EPA Method 8260 plus Acetone
2. When the system is operating, monitor wells MW -1, MW -2, MW -3, MW -4, MW -5, MW -6, MW -9, MW -
10, MW -11 and MW -12 shall be sampled at startup and every April and October thereafter for the
parameters listed below:
EPA Method 621 OD plus Acetone, Low Concentration, PQL at 0.5 ug/L or less and water level
3. Prior to sampling the parameters, the measurement of water levels must betaken. The depth to water in
each well shall be measured from the surveyed point on the top of the casing. The measuring points (top
of well casing) of all monitoring wells shall be surveyed relative to a common datum.
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l 4. Any laboratory selected to analyze parameters must be Division of Water Quality certified for those
parameters required.
5. Any additional groundwater quality monitoring, as deemed necessary by the Division, shall be provided.
IV. REPORTING REQUIREMENTS
1. Three (3) copies of the appropriate following forms shall be mailed to the address below:
1) GW -59 Groundwater Quality Monitoring : Compliance Report Form
2) GW -59A Compliance Report Form
Mail these documents to the following address: Division of Water Quality
1617 Mail Service Center
Information Processing Unit
Raleigh, NC 27699-1617
Updated blank forms (GW -59, GW -59A) may be downloaded from the Groundwater Section's website at
http://ew.ehnr.state.nc.us/ or requested from the address mentioned above.
2. The results of the sampling and analysis must be received on forms GW -59 and GW 59A on or before the
last working day of the month following the sampling month. The data of all groundwater sampling
analyses required by the permit conditions must be reported using the most recent GW -59 and GW -59A
forms along with attached copies of the laboratory analyses.
3. Catalent Pharma Solutions, LLC shall retain records of all monitoring information, including calibration
and maintenance records, continuous monitoring data and reports required by this permit, for at least 3
years from the date of the sample measurement, report or application. Records of this monitoring
information shall include, but not be limited to, the following:
1) the date, exact place, and time of sampling or measurements,
2) the individual who performed the sampling or measurements,
3) the date the analyses were performed,
4) the analytical techniques or methods used, and
5) the results of such sampling, measurements, and analyses.
4. Catalent Pharma Solutions, LLC shall report to the Mooresville Regional Office (see Section V.
NONCOMPLIANCE NOTIFICATION) any monitoring or other information which indicates:
1) any contaminant may cause an endangerment to an underground source of drinking water,
2) any noncompliance with a permit condition due to a malfunction of the system, or
3) any cause of fluid migration outside the injection zone or area.
The written submission shall contain a description of the noncompliance and its cause, the period of
noncompliance, including exact dates and times. If the noncompliance is not corrected and is expected to
continue, steps taken or planned to reduce, eliminate, and prevent reoccurrence of the noncompliance
shall be provided to the Regional Office in a timely manner.
5. The permittee shall submit an annual report summarizing the volume of effluent discharged into the
infiltration gallery and the summary results of related groundwater, influent, and effluent monitoring.
Isoconcentrations (horizontal and vertical direction) and water level contour maps shall be prepared on an
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annual basis and submitted with this report. If an annual report containing this information (e.g.
corrective action plan) is required by a regulatory agency, the permittee may submit two (2) copies of that
report in lieu of the preceding information within thirty days of its publication. The permittee shall submit
this report to the following address: Aquifer Protection Section, Groundwater Protection Unit, 1636
Mail Service Center, Raleigh, NC 27699-1636.
V. NONCOMPLIANCE NOTIFICATION
1. Catalent Pharma Solutions, LLC shall report by telephone to the Mooresville Regional Office, telephone
number [phone], as soon as possible, but in no case more than 24 hours or on the next working
day following the occurrence or first knowledge of the occurrence of any of the following:
a. Any occurrence at the groundwater remediation facility which results in the treatment of significant
amounts of contaminated groundwaters which are abnormal in quantity or characteristic, such as the
dumping of the contents of a basin or tank, the known passage of a slug of hazardous substance
through the facility, or any other unusual circumstances;
b. Any process unit failure, due to known or unknown reasons, that renders the groundwater treatment
and disposal system incapable of adequate treatment and disposal, such as mechanical or electrical
failures of pumps, aerators, compressors, etc.;
c. Any failure of a pumping station, sewer line, or treatment facility resulting in a by-pass directly to
receiving waters without treatment of all or any portion of the influent to such station or facility; or
d. Any time that self-monitoring information indicates that the groundwater treatment and disposal
system is not in compliance with any specified permit limitations.
2. Occurrences outside normal business hours may also be reported to the Division's Emergency Response
personnel at telephone number [phone] or to the Emergency Management's switchboard at (919)
733-3300. Also, persons reporting such occurrences by telephone shall file a written report within five
(5) days following first knowledge of the occurrence. This report must outline the actions taken or
proposed to be taken to ensure that the problem does not recur.
VI. APPLICABLE BOUNDARIES
The COMPLIANCE BOUNDARY for the disposal system is specified by regulations in 15A NCAC 2L,
Groundwater Classifications and Standards. The Compliance Boundary for the disposal system
individually permitted on or after December 30, 1983 is established at either 250 feet from the waste
disposal area, or 50 feet within the property boundary, whichever is closest to the waste disposal area. An
exceedance of Groundwater Quality Standards at or beyond the Compliance Boundary is subject to
remediation action according to 15A NCAC 2L.0 106(d)(2).
2. The REVIEW BOUNDARY is established around the disposal systems midway between the Compliance
Boundary and the perimeter of the waste disposal area. Any exceedance of standards at the Review
Boundary shall require action in accordance with 15A NCAC 2L .0106(d)(1).
VII. GENERAL CONDITIONS
Issuance of this permit does not constitute approval for reimbursement from the Leaking Petroleum
Underground Storage Tank Cleanup Funds (15A NCAC 2P). Additionally, the issuance of this permit
does not remove Catalent Pharma Solutions, LLC's responsibility to comply with the corrective action
requirements of the Division of Waste Management, UST Section. Furthermore, Catalent Pharma
Solutions, LLC should notify and report all changes concerning the remedial system to the Division of
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Waste Management, UST Section. It is Catalent Pharma Solutions, LLC's responsibility to comply with
_l the requirements of all involved agencies.
2. This permit shall become voidable unless the facilities are constructed in accordance with the conditions
of this permit, the approved plans and specifications, and other supporting data.
3. This permit is effective only with respect to the nature and volume of wastes described in the application
and other supporting data.
4. This permit is not transferable. In the event there is a desire for the facilities to change ownership, or
there is a name change of Catalent Pharma Solutions, LLC, a formal permit request must be submitted to
the Division accompanied by an application fee, documentation from the parties involved, and other
supporting materials as may be appropriate. The approval of this request will be considered on its merits
and may or may not be approved.
5. A set of approved plans and specifications for the subject project must be retained by Catalent Pharma
Solutions, LLC for the life of this project.
6. Failure to abide by the conditions and limitations contained in this permit may subject Catalent Pharma
Solutions, LLC to an enforcement action by the Division in accordance with North Carolina General
Statute 143-215.6A to 143-215.6C.
7. The annual administering and compliance fee must be paid by Catalent Pharma Solutions, LLC within
thirty (30) days after being billed by the Division. Failure to pay the fee accordingly may cause the
Division to initiate action to revoke this permit as specified by 15A NCAC 2T .0105 (e)(3).
8. The issuance of this permit does not preclude Catalent Pharma Solutions, LLC from complying with any
and all statutes, rules, regulations, or ordinances, which may be imposed by other government agencies
(local, state, and federal), which have jurisdiction.
9. Sixty (60) days prior to closure of the infiltration gallery, Catalent Pharma Solutions, LLC must request a
rescission of the permit from the Division of Water Quality.
10. If Catalent Pharma Solutions, LLC wants to continue operation of this system, at least six (6) months
prior to the expiration of this permit, Catalent Pharma Solutions, LLC shall request its extension. Upon
receipt of the request, the Commission will review the adequacy of the facilities described therein, and if
warranted, will extend the permit for such period of time and under such conditions and limitations as it
may deem appropriate.
Permit issued this the 13a' day of September, 2007
NORTH CAROLINA ENVIRONMENTAL MANAGEMENT COMMISSION
ge Teen WSullins, Director
Division of Water Quality
By Authority of the Environmental Management Commission
Permit Number WQ0010607
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