NC0063096_Pretreatment_Annual_Report_20200302

The Torun of
ema
LLY
' N Department of Water Quality
February 20 , 2020
Town of Holly Springs ( NPDES, NC0063096)
2019 PAR Narrative
GENERAL PROGRAM INFORMATION
o Attached is the Pretreatment Program Info Sheet.
o The HWA was submitted to DWR on 10-30-2017 and approved 02/22/18. The allocation table
attached is representative of our most current approved HWA/AT.
o The Town of Holly Springs was granted a recension of the land application permit WQ0019098
in a written letter dated August 29 , 2017. The Town did not land apply sludge in the calendar
year 2019 .
o The LTMP was submitted to PERCs Unit August 31 , 2018 and Approved October 26 , 2018 .
o There has been an addition to the TOHS Lab Staff named Easton Rains effective November 12 ,
2019.
I
GENERAL PERMIT INFORMATION
No permits lapsed or expired prior to renewal .
SIU INFORMATION
South Wake Landfill (1UP # 001 Known as SWLF
o Upon receipt of the renewed permit issued December 28 , 2018 South Wake Landfill requested a
meeting to discuss and questions of the permit as written and to request some changes in the permit
limits . This meeting was January 15 , 2019 and the request were made as follows:
o A requested increase the total nitrogen average mass limit from 227 lb . /day to 325 lb . /day.
o A decision was made to continue the 227 lb . /day limit until suitable changes are made to the
SWLF Pretreatment System in regards to continuous flow. The current system of slug loading is
not sustainable for future allocations. Slug loading such large amounts of Nitrogen and BOD can
have the potential to bring the Utley Creek Water Reclamation Facility out of compliance with
its NPDES permit. A VFD (Variable Frequency Drive) on the effluent pump could be a
potential solution.
o Reduced monitoring-
o November 20, 2018 , increased monitoring requirements discussed for Ammonia and Total j
Nitrogen from twice a month to one per week Based on recent operations of the pretreatment
facility, the request for reduced monitoring and extra Total Nitrogen allocation was denied.
P.O. Box 8 • 150 Treatment Plant Rd • Holly Springs, NC 27540 • Tel . (919) 577-1090 • Fax. (919) 577-2280
debra . batten(a�)hollyspringsnc. us 0 www. hollyspringsnc. us

o There was only 1 day during the month of January 2019 that the SWL discharged to TOHS The
wastewater was pumped and Hauled to the Lumberton WWTP . .
o The Town of Holly Springs provided SWLF microorganisms from Utley Creek Water
Reclamation Facility to re-seed their tank, which resulted in nitrification returning to their
pretreatment system but they were not successful in maintaining the nitrification process
needed for removal of Ammonia Nitrogen .
o SWL reduced their discharged flow, significantly, to prevent violating the permitted Ammonia
limit. Private contractor is removing wastewater from their tanks . (Pump and Haul records were
requested and provided . during the annual inspection . This process continues . No limits
violations issued for the year 2019 ,
o The review of the renewal permit issued on December 2018 resulted in a modification based on
the updated pollutant list and discussions between TORS , SWL, and others in January
2019.Reviewed by Vivian Thong of NC DEQ, Pretreatment Emergency Response and
Collections Unit (NC DWQ PERCS) . The permit became effective on April 1 , 2019 and expires
on December 3 1 , 2023 ,
o As a requirement of the ERP there was a Notice of Non Compliance issued to SWL on June 5 ,
2019 for failure to monitor Total Phosphorus and Ammonia . (see attached ) Response was
received via email form Troy Mitchell on May 09, 2019 (see attached) and an email of
confirmation from Stephanie Frantz of ENCO Labs dated May 20 , 2019. There were two
additional samples in addition to required monitoring to be collected by June 18 , 2019 and
reported no later than July 20, 2019, The additional monitoring was completed .
Correspondence was also received from Troy Mitchell on June 5, stating what corrective action
would be taken from SWL staff to make sure such incidents do not re-occur. (See Attached)
o There was a change in staff of SWL from Chris Sutter to Sean Wilson . Primary Contacts
continue to be Troy Mitchell and Roy Baldwin .
o Sean Wilson assisted in the annual inspection on October 10/23/2019 . The inspection
confirmed that the pretreatment system was still not functioning properly and the discharge was
extremely limited as they were trying to assure no permit violations would occur.
Noticed during the inspection , new product trial (used as a new "cover" for the landfill)
scheduled for the next morning . A delay of the trial of the product was requested a delay, as
notification had not been made in regards to the product being used . In addition , the provided
SIDS were out of date . Response from the landfill was the permit that that product would fall
under was the NC Solid Waste Section . I did however receive updated SIDS of the product .
• Segirus, (IUP#002)
o Segirus operated normally in 2019 without violations issued .
o The Industrial Pretreatment Inspection was conducted on December 18 , 2019 (See attached)
o The contract laboratory failed to login the December 13 sample submitted for phosphorus . Lab
contact was made when noticed . Due to additional lab errors the hold time was exceed . As the
error was on the contract lab and TOHS had analyzed for phosphorus in the month of
December, there was no Notice of violation issued .
Debra C . Batten
Environmental Compliance Laboratory Manager/Pretreatment Coordinator
Utley Creek Water Reclamation/Town of Holly Springs
P. O. Box 8 • 150 Treatment Plant Rd • Holly Springs, NC 27540 • Tel . (919) 577-1090 • Fax. (919) 577-2280
debra. batten nahollyspringsnc. us 0 www. hollyspringsnc. us

Pretreatment Program Info Database printed on: 12/20/2019
for Program Name Holly Springs at
WWiP Name Utley Creek C Stream Information tx IWC % at 7Q10 98,83
Program Approval Date 09/05/2006 7OQT0 FTow cfs / mgd . 11 / 0.07
Pretreatment Status 1 Q10 Flow cfs / mgd 0. 09 / 0.06
Full Stream Classification C
Region RRO Basin Number CPF07
County Wake Receiving Stream Name Utley Creek
NPDES Number NC0063096
NPDES Effective Date Last PAR Rec 03/01l2019 PAR Due Date 03/01 /2020 mercury
11 /01 /2017 Current Fiscal 1631
NPDES Expire Date 07/31 /2021 Year PCI Done
09/26/2018 required
TRUE Last Audit on 09/07/2017 Audit Year Next21 /22 es
POTW is PrimaryWWfP
Design Flow mgd 6.0000 / Design mgd is SIU permitted 5.00 Permitted SIU flow (mgd) [Pt.SIU)
WWiP SIU's 2 Program SIUs 2 --
WWTPCIU's ProgramCIUsR HWA LTMR IWS SUO ERP
date Inactive Date Next Due 05/01 /2022 j 09/30/2021
Date Received by DWR 12/31 /2016 08/31/2018 I 09/29/2016 1 111 /08/2012 L06/22/2010
Date Approved I 02/22/2018 ( 10/26/2018 10/19/2016 i 12/07/2012 08/04/2010
Adopt Date Required
Date Adopted ` 11 /06/2012
Info in this Box from Pt Contacts
Date Date Date
PT Pro Attended Attended 'Attended
Formal Name g,Pdme Phenol ext Fax HWA Wksp IUP Wksp PAR Wksp
Mr. Seenn Byrd 1 919-577-1090 919-577-2280
seann.byrd@hollyspringsnc:us Public Utilities Director P,O: Box 8 7540
Ms, Katelyn Tresino 1 11919-577-2273
Lab Technician 1P,O. Box 8 7540
Debra Batten '. Prim [phone] 1 11 4/11/2019 6/24/2016
[e-mail] Laboratory Manager/Pretreatment jP.O. Box8 754p
Pretreatment Ra ate d NOVs from DINQ DWR Central Office Contact ivien Zhong
DWR Regional Contact JCheng Zhang
I

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Chapter 9, PAR Guidance
Pretreatment Performance Summary (PPS)
1 . Pretreatment Town Name Town Of Holly Springs
2. "Primary" NPDES Number NC00 63096 _
or Non Discharge Permit # if applicable => WQ0032289
3 , PAR Begin Date, please enter 01 /01 /yyyy 3 . _> 1 /1/2019
4, PAR End Date, please enter 12/31 /yyyy 4. => 12/31/2019
5 . Total number of SIUs, includes CIUs 5 . => 2
6. Number of CIUs 6. => 1
7. Number of SIUs with no MP, or with an expired IUP 7. => 0
8 . Number of SIUs not inspected by POTV 8• => 0
9. Number of SIUs not sampled by POTW 9• => 0 _
10 . Number of SNs in SNC due to IUP Limit violations 10, => 0
It . Number of SNs in SNC due to Reporting violations I t , _> 0
12. Number of SNs in SNC due to violation of a Compliance Schedule, CO, AO or similar 12, _> 0
13 . Number of CNs in SNC 13• => 0
14. Number of SIUs included in Public Notice 14, => 0
15 Total number of SNs on a compliance schedule, CO, AO or similar 15 , => 0
16. Number of NOVs, NNCs or similar assesed to SIUs 16, => 1
17. Number of Civil Penalties assessed to SNs 17, => 0
18 . Number of Criminal Penalties assessed to SNs 18 , => 0
19. Total Amount of Civil Penalties Collecti 19, => $ 0 ,00
20 . Number of Ns from which penalties collected 20. _> 0
Foot Notes: AO Administrative Order [UP Industrial User Pretreatment Permit POTW Publicly Owned Treatment Works
CIU Categorical Industrial User NNC Notice of Non-Compliance SIU Significant Industrial User
CO Consent Order NOV Notice of Violation SNC Significant Non-Compliance
IU Industrial User PAR Pretreatment Annual Report
revised 112018: PAR PPS 2018

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SIU INSPECTION FORM The Town of
e
Holly Springs
Department of Water Quality
Name Of Industry : South Wake Landfill IUP # 001
Address Of Industry: 4121 Smithfield Rd. IUP Expiration Date:
Holly Springs, NC 27540 Dec. 31 , 2023
Industry Representatives : Title
Shawn Wilson Operations Manager.
POTW Representatives: Title
Debra Batten Pretreatment/Lab Supervisor
Katelyn Tresino Lab Analyst
Date Of Inspection: 10/23/2019 Time Of Inspection: 02:00-04 :40 am/pm
Purpose of Inspection: Annual X Other (Describe)
POTW to which IU discharges Town of Holly Springs PDES # 0063096
Is SIU currently in SNC? NO If yes, for what?
PART I - INITIAL INTERVIEW
Has anything changed since the last inspection or IUP application in the following:
COMMENTS
Product YES / NO
Raw materials used YES / NO
Manufacturing processes YES / NO
Categorical, if applicable YES / NO
Production rate YES / NO Production rate is 14,000/Day (**Only 2000discharged)
Number of employees YES / NO 10- 12 current but will be increasing in near future to 14
Number of shifts YES / NO 1 Shifts 6.30 am - 6. 0012m Previously 2 Shifts 6 :30 am —
6 .00 pm and 9:00am — 7 .00pm (Over lapping) shifts 12.5 Hr of operation
Comments: * Would Like to Start using Odor Control Foam. I requested a copy of SDS and
recommended letting me review the SDS prior to using. * *Need copies of pump and haul records.
PART II - PLANT TOUR - Visit all areas where wastewater is generated or where there
are drains to the POTW.
Plant Tour Section A - PRODUCTION AND STORAGE AREAS
1 . Are there floor drains in the production area? YES / NO Where do they go?
Locked Go to Storm water
2. Are production areas diked, contained, or otherwise constructed in such a way as to prevent harm to the
W WTP, especially from spills or slugs? YES / NO Comments :
3 . Are there floor drains in the storage area? YES / NO Where do they go? Not Applicable
4. Are storage tanks and areas diked, contained, or otherwise constructed in such a way as to prevent harm
to the W WTP, especially from spills or slugs? YES / NO Comments : 9000 Gallon tanker is driven on
Landfill side and the Loop skid is movable so it is removed from the leachate area
5 . Are process and storage tanks and pipes labeled? YES / NO Requested labeling of pipes.
6. How are off-spec raw materials, and products disposed ot? Waste sludge is taken to the top of the
landfill when generated Their Micro-organisms are currently not populating so there is no sludge
generated.
7. When is the production area cleaned? As needed according to rain events
8. Is the wastewater from cleaning the production area discharged to the POTW? YES / NO
Now a thy operation. No water used.
9. What non-process wastewaters are discharged to POTW? All discharge going to the POTW are from
the Leachate and condensate firm gas generation.
Title: SIU Inspection Form
File name: COMP.INSP App 7-D
Revision data: August 1 , 1994 Page I

eSIU INSPECTION FORM The Town of
Holly Springs
Department of Water Quality
PART II - Plant Tour Section B - PRETREATMENT SYSTEM
Ask the operator to describe pretreatment system.
1 . Does operator seem knowledgeable about the system? YES / NO Comments : Previous Contact no
longer employed Shawn has been employed 3 months but has done well Teamingthe he system and what
needs to be done.
2 . Are all units operational? YES / NO Treatment System is not in operation at this time. Micro-
organisms have not recovered They are limiting discharge until the issue has been resolved.
3 . How often does operator/maintenance person check system? Daily
4. Is there an operator for each shift? YES / NO Operators are Tyler Jones (Grade 1 , and Shawn Wilson)
5. How and when is sludge disposed of? Sludge goes to the landfill when generated. Approximately
4000 gallons every three months The higher the BOD the larger the quantity that is disposed.
6. Is there a schedule for preventative maintenance? YES / NO There is a daily compliance calendar for
maintenance required each day.
Comments:
PART II - Plant Tour Section C - SAMPLING POINT(S) AND FLOW
MEASUREMENT
(Collect a sample if desired.)
1 . Does an outside lab complete sampling? YES / NO If yes, name of lab. ENCO Labs and Pace
Analytical Laboratories
2. If industry completes sampling, ask the industry representative to describe sampling procedures.
Comments: * * * Grab samples are collected at timed intervals using the automated refrigerated sampler
during the discharge period and composited as a representative composite sample.
3 . Is flow measurement equipment operational? YES / NO Comments
4. Is there a calibration log for the flow meter? YES / NO Comments: Smith-Gardner Records
Provided
Comments: Temperature range of thermometer in use was not correct No certificate of calibration available
as required in 40 CFR Part 136 SWL needs to make sure that contract lab uses a calibrated thermometer to
verify the temperature of refrigerated unit is maintained at <6 °C during the duration of the sampling event
PART III - EXIT INTERVIEW
Review monitoring records and other SIU records required by PUP.
1 . Are files well organized? YES / NO Comments:
2. Are sample collection / chain-of-custody forms filled out properly? YES / NO
3 . Do results in files agree with reports sent to POTW? YES / NO Comments :
4. Who has authority to shut down production should a spill or slug discharge occur? Shawn Wilson -
Operations Manager and Troy Mitchell
5 . How does SIU inform employees of whom to call at POTW in case of spill/slug? Contingency Plan in
place Also List of contacts and numbers are posted throughout the facility
(If slug/spill plan is already required by POTW, review procedures).
6. Is SIU implementing slug/spill plan? YES / NO
Comments: Facility provided Spill and Slug Control Plan recently revised 06/2019
Title: Slit Inspection Form
File name: COMP.INSP App 7-D
Revision data: August 1 , 1994 Page 2

1 WASTE INDUSTRIES Wake 6330 County Old Smithfield Disposal, RoadLLC
welcome to a cleaner world ! Apex, NC 27539
RECEIVED
June 5 , 2019 �g#�� l�f
Debra Batten PUBLIC UTILITIES
Pretreatment / Lab Manager
Town of Holly Springs
Water Quality Department
Holly Springs, NC 27540
RE : Notice of Non-compliance
South Wake MSW Landfill
Permit# 001
Dear Ms. Batten,
On behalf of Wake County, Wake County Disposal, LLC (WCD) has prepared this response to
the above referenced notice (copy attached) . This response has been prepared to respond to IUP
condition Part 1 Section F : Effluent Limits and Monitoring Requirements as follows :
• Prepare a report that summarizes the past cause of noncompliance and describes all the
current and future operational changes needed to achieve compliance.
0 Include two additional sampling events in the month of June for Total Phosphorus and
Total Nitrogen (TKN, NO2+ NO3) no later than June 18,2019 with results submitted no
later than July 20`h 2019 .
Operational Recommendations
Based on data presented above, we have determined that the operational management of the
leachate system is as follows :
1 . Leachate is pumped to the storage tank from the landfill cells, the system is on a
timed cycle (by controls) to operate as follows :
a. Mixing and aeration occurs until 6 a.m. each day.
b . Near 6 : 01 a.m. the mixing and aeration ceases and settling occurs of any
suspended solids.

c. Near 8 : 00 a.m. , the discharge pump begins to send liquid to the Town's system.
This initial process is attributed to settling of sludge from the mixing and aeration
process.
d. Discharge will continue to pump at a rate of approximately 56 gallons per minute
(gpm) to remove either the volume of leachate generated the operations, or a
maximum of 25 ,000 gallons.
e. At 2 : 00 p.m. (at the latest), the discharge pump will stop .
f. By 2 : 01 p.m. the mixing and aeration begins again until 6 a.m. the flowing day.
Corrective action to deficiency
2. On each Monday or as scheduled between Enco Laboratories (Enco) and WCD
composite sampling occurs to satisfy the monitoring schedule.
a. Prior to discharge calculations are made to insure that a true composite as
described in the IUP are obtained. 100-500 Milliliters, not less than 15 minutes or
greater than 60 minutes with the total number and grab samples to be 4-24
samples .
b . Start sampler and discharge of leachate simultaneously
c. Ensure sample is refrigerated until collection is made from Enco.
d. Enco collection personnel will shake bottle, fill sample bottles and take a field PH
and temperature.
e. Enco will present chain of custody to us for signature.
f. WCD will ensure the chain of custody has the required analytical constituents
marked for repolting for the scheduled sample. To assist our personnel, we have
laminated a copy of what a chain of custody should reflect for comparison to the
actual chain of custody for a particular.
We appreciate the communication and assistance while working through these issues at the
site. If there are any questions or concerns with this report, please contact me at your earliest
convenience at (919) 291 -6472 or by email at troy.mitchell@gflenv. com
Regards,
Wake County Disposal, LLC
ly X/
Troy Mitchell
General Manager
cc :
Roy Baldwin, Wake County

Debra Batten
From: Debra Batten
Sent: Monday, May 20, 2019 4:32 PM
To: Stephanie Franz
Cc: Troy Mitchell
Subject: RE: Waste Industries- South Wake LF
Thank you Stephanie, I will be in touch with my Pretreatment Certification Inspector and will be back in touch with him
with what action IHolly Spring will have to take after they review your email.
Debra C. Batten
Environmental Compliance Laboratory Manager/Pretreatment Coordinator
Utley Creek Water Reclamation/Town of Holly Springs
PO Box 81 Holly Springs, NC 27540
Office: (919) 557-2907 ( Cell: (919) 524-2509 1 Email: debra. batten(cDhollyspringsnc . us
Town Website: y eyly_ ao� x°ircgsra .azs
1
From : Stephanie Franz <[e-mail] >
Sent: Monday, May 20, 2019 4:25 PM
To : Debra Batten <debra . batten@Hollyspringsnc. us>
Cc: Troy Mitchell <troy. [e-mail] >
Subject: Waste Industries- South Wake LF
Good afternoon, Debra,
Troy Mitchell asked me to contact you and discuss the recent hold time violations and the missing analyses from Troy's
weekly testing protocol .
Troy sent the most recent permit changes (with the effective date of 04-01-2019 and expiring on 12-31-23) to me on
March 27, and I did not look closely enough at the permit to see that you had changed the two additional parameters
(Total Nitrogen and Total Phosphorus) from monthly to weekly. Troy discovered the missing analyses on May 8, and I
added those tests to the April sampling events at that time. I verified ENCO had sufficient volume to conduct these
tests, and I let Troy know that the samples from April 1 and April 8 were outside of hold time . The sample from April 16
was close to hold time, but the other samples from April had a little more leeway. Around this same time, the
instrument upon which we analyze our Nitrogen and Phosphorus analyses became unstable, and we spent a significant
amount of time troubleshooting and diagnosing the errors. Once we were able to get the instrument operational again,
the hold time for these analyses expired . I understand the analytical results cannot be used for compliance purposes,
but I am hoping the results will give you some indication of work Troy's people are doing to the leachate .
The sampling events from May forward are permit compliant, and the results will be within hold times.
If you have any additional questions or concerns, please let me know .
Thank you,
Stephanie
Stephanie Franz
Project Manager
Environmental Conservation Laboratories, Inc.
1

The Town of
HOLLY
® ' S Department of Water Quality
SPR
June 4, 2019
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
John W. Roberson, Solid Waste Director
South Wake Landfill
P . O. Box 550
Raleigh, NC 27602
Subject: Notice of Non-Compliance
Sewer Discharge Permit No. (IUP) 001
Dear Mr. Roberson :
This letter serves as a Notice of Non-Compliance . Rather than the required Notice
of Violation, as written in the Town of Holly Springs Enforcement Response Plan
(ERP) . This decision was based on the fact that the revised permit was received
just days prior to the effective date, changing the monthly requirement as it had
been for years, to weekly . Though it is the industry' s responsibility to review the
permit and be aware of any changes and to inform their lab of the analysis the
industry needs and to make sure those needs are met such that the permit
requirements are complete .
The letter does serve as Notice of Non-Compliance for failure to have all
parameters analyzed as required by your current Industrial User Permit. South
Wake Landfill (SWL) failed to have samples analyzed for Total Phosphorus, and
Total Nitrogen on the sample collected April 8 , 2019 as required by the permit
dated March 21 , 2019 . (See attached) In addition to the failure to have the analysis
done on the April 81h sample, though the contract lab had been told that the sample
collected on April 16`h, 2019 also was required to have the Total Phosphorus

analyzed, the laboratory had equipment failure . Because this failure was beyond
your control, no deficiencies were issued for the April 16' sample . As this was
beyond your control .
A written response describing the cause of this deficiency and steps taken to
prevent such deficiencies going forward. This response must be submitted to me
no later than June 15 , 2019 . My recommendation would be that verification that
all required parameters have been verified as listed on the Chain of Custody as
soon as it is received by your personnel .
As the data is required of your permit to be used as part of the compliance
judgement, SWL must collect two extra samples for Total Phosphorus and
Total Nitrogen (TKN, NO2+NO3) no later than June 18 2019. The results of
these analysis must be submitted to me on or before July 20, 2019 .
The Town of Holly Springs, according to the Enforcement Response Plan (see
attached), states there will be a fine assed for Self-Monitoring Violations . As the
issuance is only a Notice of Non Compliance rather that a Notice of Violation, the
fines will be waved.
If you have any questions please contact me at [phone] .
Sincerely,
(1 ,
Debra Batten,
Pretreatment/Lab Manager
Town of Holly Springs
Cc . Seann Byrd, T. O . H. S .
Troy Mitchell, S .W.L .
Attachments : IUP Current as of March 21 , 2019
Enforcement Response Plan

Debra Batten
From: Debra Batten
Sent: Thursday, May 09, 2019 9:39 AM
To: Troy Mitchell
Subject: Re: T phos
Do they have any other of your weekly samples?
Sent from my iPhone
On May 9, 2019, at 6 :50 AM, Troy Mitchell <troy . [e-mail]> wrote :
Good morning Debra, I just gained knowledge yesterday that my lab group neglected to observe the
changes to the IUP schedule I sent them . With this being said they are able to get everything analyzed
except one of my Total Phos values for the sample of April 8t1 . See attached e-mail from Enco (Steph )
they have the 81h sample however it is out of hold time, should we leave this date blank or run analytical
on the sample?
Thank you
Troy
Troy Mitchell I Landfill General Manager II
Waste Industries I GFL Environmental Inc.
6330 Old Smithfield Road, Apex, NC, 27539 '...
T (800) 207-6618 Ext. 31520 ( C (919) 291 -6472 1 troy, mitchell(a gflenv.com I www.wasteindustries.com I www.pflenv.com
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SIU INSPECTION FORM The Town of
Holly Springs
Department of Water Quality
Name of Industry: Segirus IUP # 002
Address of Industry:475 Green Oaks Parkway IUP Expiration date: July 13, 2018
Industry Representatives : Sean Rassmussun Title: Env. Health & Safety Manager
Rachael Baker Title : Env. Health & Safety Consultant
POTW Representatives : Debra Batten Title: Lab/Pretreatment manager
Katelyn Tresino Title : Lab Technician
Brendan Reeser Title : Reclaim & Fog Manager
Date Of Inspection : 12/18/19 & 12/23/19 Time Of Inspection : 1 :45 am/pm
Purpose of Inspection : Annual X Other ( Describe )
POTW to which IU discharges Town of Holly Springs NPDES # 0063096
Is SIU currently in SNC? No If yes, for what?
* Inspection ended at 4 :45 PM on 12/18/19 as staff was leaving for the day. Returned
on 12/23/19 to complete inspection
PART I - INITIAL INTERVIEW
Has anything changed since the last inspection or IUP application in the following:
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COMMENTS
Product : YES / NO Flu vaccine
Raw materials used YES / NO Phosphate buffer/ Saline, Nitrogen based growth
media, NaOH , proteins
Manufacturing processes Categorical, if applicable : YES / NO
Production rate : YES / NO Increase from 42-56 million doses were made last year.
In the case of a pandemic up to 250 million doses of vaccine is made. They will double !,
that cap by 2021
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Number of employees : YES / NO There are 790 employees . In addition to this they
also hire outside contractors .
Title: SIU Inspection Form
Filename: COMP.INSPApp7-D
Revision data : August 1, 1994 Page 1 '..

SIU INSPECTION FORM The Town of
GOA
Holly Springs
Department of Water Quality
Number of shifts :YES / NO Two 12hr shifts for the production laboratory and have a
3rd line on standby. One 8 hr shift for the administrative positions
Comments :
PART H - PLANT TOUR - Visit all areas where wastewater is generated or where there
are drains to the POTW.
Plant Tour Section A - PRODUCTION AND STORAGE AREAS
1. Are there floor drains in the production area? YES / NO Where do they go? In most
GMP areas there are drains that are able to be opened in an emergency and scheduled. Other
than that dirty side where parts are washed .
2. Are production areas diked, contained, or otherwise constructed in such a way as to
prevent harm to the WWTP, especially from spills or slugs? YES / NO Comments :
3. Are there floor drains in the storage area? YES / NO Where do they go? Dry storage
4. Are storage tanks and areas diked, contained, or otherwise constructed in such a way as to
prevent harm to the WWTP, especially from spills or slugs? YES / NO Comments :
5. Are process and storage tanks and pipes labeled? YES / NO
6. How are off-spec raw materials, and products disposed of? Disposed of by TEI (Triumvirate
Environmental Inc.)
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7. When is the production area cleaned ? The production area is clean daily but the floors in
this area are cleaned monthly.
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8. Is the wastewater from cleaning the production area discharged to the POTW? YES / NO
Title: SIU Inspection Form
Filename: COMP.INSPApp7-D
Revision data: August 1, 1994 Page 2 ',,