NCGNE1394_NE Approval_20200804

Roy COOPER
Covernor
MICHAEL S. REGAN
Srcrcrar}
BRIAN WRENN
Dirrcrar
Merck & Co.
Attn: Kacey Fetcho-Phillips
100 Rodolphe Street B
Durham, NC 27712
NORTH CAROLINA
Environmental Quality
August 4, 2020
Subject: No Exposure Certification NCGNE1394
Organon Teknika Corporation
Durham County
Dear Mr. Fetcho-Phillips:
The Division of Energy, Mineral and Land Resources (DEMLR) has reviewed your submittal of the No
Exposure Certification for Exclusion from NPDES Stormwater Permitting Form. Based on your submittal and
signed certification of no exposure at the above referenced facility as well as observations made by Thad
Valentine with the Raleigh Regional Office on July 31, 2020, the Division is granting your conditional
exclusion from permitting as provided under 40 CF 122.26(g), which is incorporated by reference in North
Carolina Regulations.
Please note that under the No Exposure Certification, you are obligated to maintain no exposure conditions at
your facility. If conditions change such that your facility can no longer qualify for the No Exposure
Certification, you are obligated to immediately obtain NPDES Stormwater permit coverage for your
stormwater discharge. Otherwise, the discharge becomes subject to enforcement as un-permitted discharge.
You must self -recertify annually that the No Exposure conditions are being met by completing the Annual Self
Recertification Form, which can be found at littps:lldeq.nc.gov/about/divisions/eilet-gy,:iiiiiieral-land-
resources/nodes-no-ex ot� sure. The completed form does not need to be submitted but shall be kept onsite
and made available upon request.
Your conditional exclusion from permitting does not affect your facility's legal requirements to obtain
environmental permits that may be required under other federal, state, or local regulations or ordinances. If
you have any questions or need further information, please contact Thad Valentine at [phone].
Sincerely,
­16�kAms,
J V 49,
for Brian Wrenn
Director, DEMLR
_Enclosure: Compliance Inspection. Report
cc: Jose Centeno, Organon Teknika Corporation
RRO — DEMLR, Stormwater Files-NCGNE1081
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Compliance Inspection Report
Permit: NCGNE1394 Effective: Expiration: Owner: Merck Sharp & Dohme Corp
SOC: Effective: Expiration: Facility: Organon Teknika Corporation
County: Durham 100 Rodolphe St B
Region: Raleigh
Eno Valley NC 27712
Contact Person: Jose Centeno
Title:
Phone: [phone]
Directions to Facility:
Facility is located 0.5 turning left on Red Mill Rd. coming north from Old Oxford Rd or 1 mile turning left on Teknika Parkway coming
north from Oxford Rd.
System Classifications:
Primary ORC: Certification: Phone:
Secondary ORC(s):
On -Site Representative(s):
Related Permits:
Inspection Date: 07/31/2020 Entry Time 10.30AM Exit Time: 11,30AM
Primary Inspector: Thaddeus W Valentine Phone:
Secondary Inspector(s):
Reason for Inspection: Routine Inspection Type: Compliance Evaluation
Permit Inspection Type: Stormwater Discharge, No Exposure Certificate
Facility Status: a Compliant Not Compliant
Question Areas:
Miscellaneous Questions Misc
(See attachment summary)
Page 1 of 3

Permit: NCGNE1394 Owner - Facility: Merck Sharp & Oohme Corp
Inspection date: 07/31/2020 inspection Type: Compliance Evaluation Reason for Visit: Routine
Inspection Summary:
Site visit conducted in response to submittal of NoExposure Certification. Met with Jose Centeno and others. The facility
manufactures vaccines for bladder cancer. No processes are conducted outside the building, no materail is stored outside,
dumpsters have covers. There were no drains observed in the area. Organon Teknika Corp leases the building. The owner of
the building and surrounding industrial area has seperate permit coverage and outfalls are sampled in accordance. Based on
the observations made at the time of the site visit, a No Exposure Certification is being granted.
Page 2 of 3

Permit: NCGNE1394 Owner - Facility: Merck Sharp & Qohme Corp
Inspection Date: 07/31/2020 Inspection Type. Compliance Evaluation Reason for Visit: Routine
Misc
Is the facility compliant?
Comment:
Yes No NA NE
E ❑ ❑ ❑
Page 3 of 3