20150465 Ver 2_More Info Received_20230126

The following call notes were provided to the applicant as a request for additional
information. The Corps request is in bold text and the applicant’s response is in italics.

Call notes – October 19, 2022. Chris Huysman, Larry Lane, Chris Hopper
Please share the T&E survey results.
T&E report reviewed by John Ellis and no further action required per email from him to the Corps
on December 15, 2022.

Offsite Alternatives: Contiguous ‘relates to FDA’ licensure. Please expand by referencing
licensure requirements. Would impacts be less?
The requirements and timeline associated with registration and licensure for a new
pharmaceutical manufacturing site versus expanding on an existing, registered and licensed site
are significant and related to a number of infrastructure and siting constraints. There are two
primary code references outlining the licensure of drug product facilities:

 21 USC Chapter 9, Subchapter V: Drugs and Devices
 81 FR 60170 - Requirements for Foreign and Domestic Establishment Registration and
Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License
Application, and Animal Drugs

The steps that a new site would require to register include the following:

1. Identify a parcel of sufficient size, with appropriate zoning and access, along with the
necessary and reliable water (175,000 GPD), sewer (370,000 GPD), electrical (~45 MVA)
and natural gas utilities available.
2. Conduct legal and regulatory due diligence, purchase the parcel, survey and record the
transaction.
3. Once the purchase has been recorded and now under Novo Nordisk Pharmaceutical
Industries, LP, file a registration with Dun and Bradstreet to obtain a unique DUNS
number.
4. Once a unique DUNS number is obtained, file new site registration with FDA per the
requirements cited above.
5. FDA then verifies DUNS number and sends request for additional information needed to
finalize the FEI (FDA Establishment Identifier).
6. Once the additional information requested has been provided and verified, the FDA then
issues the FEI.

7. Novo Nordisk would then submit registration paperwork to complete the process.

Items 1-6 would be additional steps and require additional time related versus on-site
expansion. Oftentimes, new sites require the establishment of supporting infrastructure after
the site selection process and FDA approval are completed. In this case, the applicant has
identified that the time necessary to ultimately secure the FDA approvals would minimally be an
additional 18 months. Expansion sites typically have all the necessary supporting infrastructure.

Across Powhatan Road are large undeveloped uplands that would accommodate the
expansion and are already owned by Novo Nordisk. This should be addressed.
The undeveloped uplands owned by Novo Nordisk at the API site are reserved for planned
expansion of the API facility operations based on forecasted demand. The first phase of that
multi-phased project is set to begin by end of 2023. All developable areas on the API parcel
were reserved for future development as part of the wetland permit (SAW 2015-02127) that
was issued for the site.

Would other sites result in more environmental damage? Transportation
safety/infrastructure adequacy (bridges, etc)? Stream/wetland crossings?
Any off-site alternative will greatly increase the amount of truck traffic to transfer bulk finished
product, intermediates, raw materials and finished product and would greatly increase the risk
of contaminating our aseptic product. This transportation will result in secondary and
cumulative impacts to the environment from carbon generating sources and possibly direct
impacts to waters for road infrastructure improvements for the substantial quantity of tractor
trailers / day necessary to serve the facility.
Other sites would require the installation of significant new sewer, water and electrical
infrastructure. The anticipated impacts from infrastructure could exceed the proposed impacts
based on the likely extension of these facilities to other sites. Impacts would be associated with
power substations, sewer pump stations, treatment facilities, and utility corridors. Then, once
installed, this infrastructure would then likely be the catalyst for additional new development
and more environmental damage.
The existing site possesses all of the necessary water, sewer, power and transportation
infrastructure for the development of the project and will have less environmental impact than
expanding operations to other sites.

The text states that Novo Nordisk purchased the facility in 1991 from Locke Pharmaceuticals
to launch its North American footprint. We appreciate the value of purchasing an existing

facility – but what other factors were considered at the time. Offsite alternatives need to be
stronger.
That historical knowledge is proving very difficult to obtain but the institutional understanding is
that this facility and location were selected based on location and adjacency to other
pharmaceutical facilities, availability of infrastructure suitable for our intended operations,
along with availability of trained personnel in the area.
Collocating with like kind industries is beneficial to municipalities and utilities that provide
services. The purchase of the Locke facility was in part due to the fact that Clayton had an
understanding of the water and sewer demands necessary for pharmaceutical manufacturing.
This understanding extended to the chemistry of the waste water and the raw water that is used
for the production facilities. Power and gas capacity was available at the site at the time and
the utility companies were familiar with the demand cycles necessary for the specialized
manufacturing.
At the time that the site was selected there was one major pharmaceutical facility in Clayton
and multiple pharmaceutical and biotechnology production and research & development sites in
the Research Triangle Park. The production personnel are highly trained skilled employees that
develop skills that can be transferred from one employer to another. In this way, collocating
with like kind industries ensures a reliable pool of trained personnel.
The Locke site included shell buildings and infrastructure that were beneficial to Novo Nordisk’s
establishment of North American operations. The parcel size was appropriate for future
development and the collocation with like kind industries proved to make the site the selected
alternative. At the time that the site was secured it was reasonable to expect wetland impact
permits for up to 1 acre of wetlands and streams based on then applicable regulatory
limitations.
The site was selected because it met all of the identified siting requirements.

Project Description refers to “FDA Compliance” – please reference the relevant rules and
regulations.
21 CFR Parts 210 and 211 contain facility and licensure requirements for a compliant facility.

Text says up to 250 new jobs would be created. The selected alternative shows 745 parking
stalls. What is the need for this much parking?
The text reflects an early estimate of personnel needed and what Novo Nordisk has committed
to local and state agencies from an Economic Development Assistance perspective. The

additional parking spaces will be needed to support final staffing and further evaluation of an
onsite parking structure is ongoing which would reduce the surface impacts.
The construction of the proposed facilities will include up to 700 highly skilled laborers.

JD was to be submitted with application
No action needed at this time.

Verbiage regarding the on-site BMP? (working on it)
The administrative record (SAW 2015-00471) includes a Jurisdictional Determination map for
the project that identifies the pond located between Powhatan Road and the front of the facility
as non-jurisdictional. This pond was converted to a stormwater treatment facility circa 2004