WQ0010607_Final Permit_20090901

KDEHR
North Carolina Department of Environment and Natural Resources
Division of Water Quality
Beverly Eaves Perdue Coleen H. Sullins
Governor Director
September 1, 2009
Dina Kostakis
Catalent Pharma Solutions
2725 Scherer Drive North
St. Petersburg, FL 33716-1016
Subject: Groundwater Remediation Permit Number WQOO10607
Catalent Pharma Solutions/Chelsea Labs Groundwater Remediation Facilities
Union County
Dear Ms. Kostakis:
Dee Freeman
Secretary
In accordance with your request for permit renewal received May 13, 2009, we are forwarding herewith
Permit No. WQ0010607, dated September 1, 2009, issued to Catalent Pharma Solutions, LLC, for
continued operation of the subject groundwater remediation facility.
This permit shall be effective from the date of issuance until August 31, 2014, shall void Permit No.
WQ0010607 issued September 13, 2007, and shall be subject to the conditions and limitations 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.
Please note the following changes to Part III. MONITORING REQUIREMENTS in this permit:
1. Part III.1 has been added to clarify existing permit language stating that monitoring and reporting
requirements are suspended while the infiltration gallery is not in operation.
2. As requested in the cover letter accompanying the permit application, acetone has been removed
from the list of analytical parameters in Parts III.2 and III.3 of this permit.
3. Monitoring wells MW -2, MW -3, MW -4, and MW -5 have been removed from the list of
monitoring wells specified in Part III.3 of this permit because they serve as recovery wells and the
treatment system influent is already required to be sampled when the system is in operation.
1617 Mai! Service Center, Raleigh, North Carolina 27699-1617
Location: 512 N. Salisbury S., Raleigh, North Carolina 27604
Phone: [phone] V FAX: [phone] Customer Service: 1-877-623-6746
Interne`.www.nwatemualiN.om
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W00010607 Permit Cover Letter
Catalent Pharma Solutions, LLC
September 1, 2009
Page 2 of 2
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.
If you need any additional information concerning this matter, please contact Thomas Slusser at (919)
715-6164 or thomas.slusserrunedenr.ttov.
Sincerely,
L1`Coleen H. Sullins
cc: Union County Health Department
Mooresville Regional Office, Aquifer Protection Section
Michael Shade, Rogers & Callcott Engineers, Inc.
Technical Assistance and Certification Unit
W00010607 Permit File
W00010607 Notebook File

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
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, a 1,400 gallon Gravity
Settling Chamber, a 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 to remediate chlorinated
solvents and other volatile organic compounds, with no discharge of wastes to the surface waters, pursuant to the
permit renewal application received May 13, 2009, 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 August 31, 2014, shall void Permit No. WQ0010607
issued September 13, 2007, and shall be subject to the following specified conditions and limitations:
I. PERFORMANCE STANDARDS
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 ground waters.
3. The issuance of this permit shall not relieve the Permittee of the responsibility for damages to surface or
ground waters resulting from the operation of this facility.
4. Any residuals generated from these treatment facilities must be disposed in accordance with General
C Statute 143-215.1 and in a manner approved by the Division.
5. Diversion or bypassing of the untreated groundwater from the treatment facilities is prohibited.
Page 1 of 5

II. OPERATION AND MAINTENANCE REOUIREMENTS
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 weatherproofed 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), the Permittee 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 (frequency) physical
inspections, on a case-by-case basis, following at least two years of successful operation.
5. The Permittee 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 the Permittee.
This log of inspections shall be maintained by the Permittee 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. Permit monitoring and reporting requirements are suspended while the infiltration gallery is not in
operation. The Division should be notified in writing 30 days prior to operation of the system. These
requirements will begin when system operation begins. Please note that monitoring and reporting
requirements suspended by this permit do not affect monitoring and reporting that may be required by any
other permit or corrective action plan at this site.
2. When the system is operating, the influent and effluent from the treatment system shall be sampled at
start-up and monthly for the parameters specified below:
EPA method 6210D or EPA Method 8260
3. Monitor wells MW -1, 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 or EPA Method 8260 and water levels
4. Prior to sampling the parameters, the measurement of water levels must be taken. 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.
Page 2 of 5

5. Any laboratory selected to analyze parameters must be Division of Water Quality certified for those
parameters required.
6. Any additional groundwater quality monitoring, as deemed necessary by the Division, shall be provided.
1. Three (3) copies of the following forms shall be mailed to the address below:
a. GW -59 Groundwater Quality Monitoring : Compliance Report Form
b. 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) maybe downloaded from the Division of Water Quality
website at htt1)://h2o.em.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. The permittee 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:
a. the date, exact place, and time of sampling or measurements,
b. the individual who performed the sampling or measurements,
c. the date the analyses were performed,
d. the analytical techniques or methods used, and
e. the results of such sampling, measurements, and analyses.
4. The permittee shall report to the Mooresville Regional Office (see Section V. NONCOMPLIANCE
NOTIFICATIONI any monitoring or other information which indicates:
a. any contaminant may cause an endangerment to an underground source of drinking water,
b. any noncompliance with a permit condition due to a malfunction of the system, or
c, 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
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
Page 3 of 5

report to the following address: Aquifer Protection Section, Groundwater Protection Unit, 1636 Mail
Service Center, Raleigh, NC 27699-1636.
V. NONCOMPLIANCE NOTIFICATION
1. The Permittee shall report by telephone to the Mooresville Regional Office, telephone number 704-663-
1699 , 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 groundwater that lare 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
1. 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 December 30, 1983 is established at either (1) 250 feet from the waste disposal
area, or (2) 50 feet within the property boundary, whichever is closest to the waste disposal area. An
exceedance of Class GA 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 Class GA Standards at the
Review Boundary may require action in accordance with 15A NCAC 2L.0 I 06(d)(1).
VII. GENERAL CONDITIONS
1. Issuance of this permit does not constitute approval for reimbursement from the Leaking Petroleum
Underground Storage Tank Cleanup Fund (15A NCAC 2P) or any other fund. Additionally, the issuance
of this permit does not remove the permittee's responsibility to comply with the corrective action
requirements of the Division of Waste Management. Furthermore, the permittee should notify and report
all changes concerning the remedial system to the Division of Waste Management. It is the permittee's
responsibility to comply with 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.
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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 the Permittee, 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 the Permittee for the
life of this project.
6. Failure to abide by the conditions and limitations contained in this permit may subject the Permittee 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 the Permittee 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 the Permittee 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, the permittee must request a rescission of the
permit from the Division of Water Quality. Guidelines for the closure of the infiltration gallery may be
obtained from ham://h2o.enr.state.nc.us or requested from the Division of Water Quality.
10. If the permittee wants to continue operation of this system, at least six (6) months prior to the expiration
of this permit, the permittee 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 1'` day of September 2009
NORTH CAROLINA ENVIRONMENTAL MANAGEMENT COMMISSION
V Coleen H. Sullins, Director
Division of Water Quality
By Authority of the Environmental Management Commission
Permit Number WQ0010607
Page 5 of 5

Cardinal Health PTS, LLCChelsea Labs
Layout of Monitoring Wells
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