90
February 3, 2015 Mail Control No. License No. Docket No. 585630 07-30728-01 030-35986 Licensing Assistance Team U.S. Nuclear Regulatory Commission Region I 2100 Renaissance Blvd King of Prussia, PA 19406-2713 Subject: Mail Control No. 585630 - Amendment to License No. 07-30728-01 Dear Mr. Dennis Lawyer, lncyte Corporation 1801 Augustine Cut-off Wilmington, Delaware 19803 Tel 302.498.6776 Fax 302.425.2109 Web www.incyte.com ... !-·-!.<· en :r.:i :::.:;:: This is to provide our response to NRC's e-mail dated January 15, 2015, requesting additional information to lncyte Corporation's December 18, 2014 request for removal of the DuPont Experimental Station, buildings E336 and E400, Route 141 & Henry Clay Road, Wilmington, Delaware 19880 location from NRC Material License No. 07-30728-01. Following is each of the items for clarification {1.a. through b. and 2.a through 1.) followed by our response (shown in bold font). 1. Prior to termination of a license, 10 CFR 30.35{g), 30.36{k)(4) and 30.51 require that you submit certain records to the NRC. a.. for unsealed materials with half-lives greater than 120 days, records for disposal made pursuant to 10 CFR 20.2002 (alternate disposal procedures, including burial authorized prior to January 28, 1981), 20.2003 (disposals to the sanitary sewerage system), 20.2004 (incineration of wastes), 20.2005 (disposal of specific wastes including liquid scintillation cocktail and animal tissue), and 20.2103{b)(4), evaluations of effluent releases. b. records important for decommissioning as described in 30.35(g), 40.36(f) and 70.25(g). Examples of such records include but are not limited to: records of contamination, identifying the radionuclides, quantities and concentrations; as-built drawings and modifications of structures and equipment in restricted areas and locations of inaccessible contamination such as buried pipes; a single list, updated at least every 2 years, of areas to which access is limited for the purpose of radiation protection (restricted areas); and records related to the provision of financial assurance. lncyte Corporation is retaining records for all of the above records as required for the Buildings E336 and E400, Route 141 & Henry Clay Road, Wilmington, Delaware facility. 1 ... t" !""'\') 'Nr .. r • .;....1.,, .......... 1.

Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

February 3, 2015

Mail Control No. License No. Docket No.

585630 07-30728-01 030-35986

Licensing Assistance Team U.S. Nuclear Regulatory Commission Region I 2100 Renaissance Blvd King of Prussia, PA 19406-2713

Subject: Mail Control No. 585630 - Amendment to License No. 07-30728-01

Dear Mr. Dennis Lawyer,

lncyte Corporation 1801 Augustine Cut-off Wilmington, Delaware 19803

Tel 302.498.6776 Fax 302.425.2109 Web www.incyte.com

... !-·-!.<·

en :r.:i :::.:;::

This is to provide our response to NRC's e-mail dated January 15, 2015, requesting additional information to lncyte Corporation's December 18, 2014 request for removal of the DuPont Experimental Station, buildings E336 and E400, Route 141 & Henry Clay Road, Wilmington, Delaware 19880 location from NRC Material License No. 07-30728-01. Following is each of the items for clarification {1.a. through b. and 2.a through 1.) followed by our response (shown in bold font).

1. Prior to termination of a license, 10 CFR 30.35{g), 30.36{k)(4) and 30.51 require that you submit certain records to the NRC.

a.. for unsealed materials with half-lives greater than 120 days, records for disposal made pursuant to 10 CFR 20.2002 (alternate disposal procedures, including burial authorized prior to January 28, 1981), 20.2003 (disposals to the sanitary sewerage system), 20.2004 (incineration of wastes), 20.2005 (disposal of specific wastes including liquid scintillation cocktail and animal tissue), and 20.2103{b)(4), evaluations of effluent releases.

b. records important for decommissioning as described in 30.35(g), 40.36(f) and 70.25(g). Examples of such records include but are not limited to: records of contamination, identifying the radionuclides, quantities and concentrations; as-built drawings and modifications of structures and equipment in restricted areas and locations of inaccessible contamination such as buried pipes; a single list, updated at least every 2 years, of areas to which access is limited for the purpose of radiation protection (restricted areas); and records related to the provision of financial assurance.

lncyte Corporation is retaining records for all of the above records as required for the Buildings E336 and E400, Route 141 & Henry Clay Road, Wilmington, Delaware facility.

1 "'~/"""' 1 1 r·~-.,.. ... ,,,~ t" !""'\') 'Nr .. ~~.J r • .;....1.,, .......... i..:1:.""l.~."\..-i,,,;."",.,H--

1.

Page 2: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

2. The DuPont Experimental Station Building 336 and 400 Radiological Final Survey Report had several items that did not appear to be accurate or was missing information needed to validate and confirm results. Please clarify the following and resubmit the report as needed.

Attached please find RSO lnc.'s, clarification to (2.a. through I.) for the NRC's January 15, 2015 e-mail and a revised report for resubmission to the NRC.

If you require additional information please contact Mark Czerwinski at 302-498-6827 or by e-mail at [email protected].

Sincerely, /

//;/. /~ ~ &a1//L'l:'c_ , I L~-1 z, \.__;'

Mark Czer ski Associate, irector, EHS & RSO lncyte Corporation 1801 Augustine Cut-off Wilmington, Delaware 19803

Page 3: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSQlnc. January 30, 2015

Mark Czerwinski lncyte Corporation 1801 Augustine Cut-off Wilmington, DE 19803-4404

Radiation Service Organization

Subj: lncyte Dupont Experimental Station Bldg. 336 and 400 Final Survey Report Re: Response to NRC's email of January 15, 2015

Dear Mr. Czerwinski:

This is to provide our responses to the NRC's email of January 15, 2015. Following is each of the items for clarification (2.a. through I.) followed by our response (shown in bold font). Also we have provided a revised report (attachment) for resubmission to the NRC.

2. The DuPont Experimental Station Building 336 and 400 Radiological Final Survey Report had several items that did not appear to be accurate or was missing information needed to validate and confirm results. Please clarify the following and resubmit the report as needed.

a. The report describes P-33 as a potential contaminate in some of the laboratories, specifically Building E336 labs 238, 266, Dock Cabinet, and Building 400 Lab 1440. The report in section 2.3 states that only H-3 and C-14 were considered potential contaminates but then states that P-33 was identified as a potential contaminate. Please explain what the distinction is made in this section and what implications it had on the survey design.

Section 2.3 has been re-written to accurately describe the potential radionuclides. p.33 was a potential contaminate. P-33 Is a beta emitter with a beta energy higher than that of C-14 (294 keV max), and a DCGL higher than that of C-14. P-33 did not impact the survey design because the C-14 DCGL was more restrictive, and the detection methods used are the same as that for C-14.

We also added S-35 as a potential contaminate, as our own clarification of past use shows a one-time use about 1 year prior to the survey. S-35 is a beta emitter with a beta energy (167 keV) nearly identical to that of C-14 and a DCGL also higher than that of C-14. Adding S-35 as a potential contaminate had no impact on the survey design for the same reasons provided above.

b. It is unclear how you determined the DCGLw for P-33. Please provide the specific reference or Dando calculation that supports this value.

We re-calculated the DCGL using Dando Version 2.1 O and obtained a value of 4.09E+07 (a copy of the DandD summary report is attached). We have corrected the report to this value. While it is slightly lower than the value in the report, it is relatively close and the difference had no effect on the survey design (e.g.: calculations of the number of survey locations needed in a survey unit is the same as before and the same as for H-3 and C-14).

c. In section 2.10, step 1 discusses P-33 as radioactive material used in the facility but then it infers that it could not exceed the OCGL. No justification is made on this statement. Step 2 did not discuss P-33.

Washington DC (301) 953·2482 www.rsoinc.com Baltimore (410) 792-7444

Page 4: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc.

We have re-written Step 1 through Step 7 to more accurately discuss and include P-33 and S-35. We also added this information: The amounts of radioactivity used at any 1 time were relatively small (milllcurle or sub-millicurie amounts) and there were no spills or incidents resulting in widespread contamination.

d. There is no discussion of how P-33 was surveyed or if the results for the data given support release of the facility for P-33.

We have added statements and information in Section 2.9 regarding the applicability of the survey methods for each radionuclide, including P-33 and S-35.

e. Section 2.4 states that laboratory rooms where relatively high activity concentration of radioactivity were used were treated as Class 2 areas. There was no discussion of which labs were class 2 and if any were class 3. If any laboratory was considered Class 2, based on the survey diagrams given, there was no apparent systematic square grid with random start surveys performed as stated in section 2.9.

We have removed that sentence regarding treating any of the laboratory rooms as Class 2 areas as they are all treated as Class 3 areas.

f. Section 2.7, Table 4 is titled, "List of radionuclides listed on license (with data) and recent use." Please define what recent use means. In particular, were some laboratories not included that had tritium and carbon 14 use longer than 4 years ago?

We have removed the reference to recent use and rephrased the description for Table 4. All laboratory rooms that used tritium and C-14 were included.

g. Section 2.9 describes detector surveys. For scan surveys, it does not describe the percentage of area that was scanned. Normally this is different for Class 2 and 3 areas, but this did not appear to be described either. Very few static surveys were performed on walls. Were walls scanned?

Yes, scan survey were conducted on 5 to 10% of the walls and 50 to 90% of the bench tops and floor areas.

h. For the table described as Survey Data, subtitled Survey Meter Information:

• The serial number of the meter is the same as the serial number of the probe. Calibration data shows that the meter number and probe number is different. This makes it unclear as to how efficiency of the detector was determined if the probe has the same serial number.

• Meter 3 states that it used Ludlum model 43-37 probes, but the detector size is 126 square centimeters. Model 43-37 should be 584 square centimeters.

The correct information has been entered in the revised report.

• The page gives formulas in the bottom section. These values are sometimes not given or not clear in the above data chart. For example, the human factor efficiency that is used is not given. Counting interval is not given. Source efficiency in formula is stated as just efficiency, 2pi efficiency is displayed. Background Counts is given as Background (c) in table. T counting time in minutes is different for background and survey counting and thus needs to be factored. Source efficiency is not given. Based on these factors this license reviewer could not duplicate the numbers calculated in the survey data. Also carbon-14 is a low energy beta and a source efficiency of half that for P-33 is normally used. Please provide all data used and make the data in the table consistent with the variables listed on the page. It is suggest to send a detailed example calculation.

Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444

Page 5: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc.

We have updated our spreadsheet and using a "source efficiency" of 0.25 for C-14 and provided a detailed sample calculation page in the results and a description of the formulas and calculations in the body of the report.

i. Building 336, Lab 228 survey data shows the Gross high (cpm) being lower than the Gross Average (cpm) which seems to be an inaccuracy. Please correct or explain.

The correct information has been entered In the revised report.

j. Surveys do not appear to include Building E336 Dock cabinet or 282 Freezer Farm which was described in section 2.7. There is a survey for the Deck Area which did not seem to correlate with any description in section 2.7.

The area identified as Dock Cabinet In Section 2.7 is the same as Dock Area as shown on the floor diagram and Is Identified as Dock Area on the survey data report. The area Identified as 282 Freezer Farm In Section 2.7 is the area identified as room 282 on the survey data report.

k. The calculations for carbon 14 did not seem to include a factor for the low energy self-absorption of measuring low beta energy on surfaces. Please describe what factors were used and how this was accounted.

We have updated our spreadsheet and using a "source efficiency" of 0.25 for C-14 and provided a detailed sample calculation. This also changed the data shown in the data sheets and we have changed the data used and shown in the body of the report.

I. Calibration data was supplied for four instruments. Only two were used for these surveys. Why was the additional detector calibration data submitted? Is the survey data inaccurate to which detectors were used?

The additional survey meter calibration reports have been removed as they were not used for the Final Survey. The survey data Is accurate as to which detectors were used.

Please contact me or Korressa Williams if you have any questions or need any additional information.

Sin/ly,

i-~v1~ Gregory D. Smith, CHP RSO, Inc.

Washington DC (30 I) 953-2482 """' .rsoinc.com Baltimore (410) 792-7444

Page 6: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

DandD Building Occupancy Scenario

DandD Building Occupancy Scenario

DandD Version: 2.1.0 Run Date/Time: 1/21/2015 11 :36:54 AM Site Name: lncyte Description: P-33 FileName:C:\Program Files\DandD2\docwnents\P-33 DandD Bldg Screening Value.med

Options:

Implicit progeny doses NOT included with explidt parent doses Nuclide concentrations are distributed among all progeny Number of simulations: 12800 Seed for Random Generation: 8718721 Averages used for behavioral type parameters

External Pathway is ON Inhalation Pathway is ON Secondary Ingestion Pathway is ON

Initial Activities:

Area of Nudidc:

Contamination (m2)

Distribution

33P ~LIMITED K'.ONSTANT( dpm/I 00 cm .. 2)

lu.iification ff'r .. , -·Screening Value Value 4.09E+07

Site Specific Parameters:

General Parameters:

Correlation Coefficients:

Summary Results:

90.00% of the 12800 calculated TEDE values are< 2.48E+Ol mrem/year. The 95 % Confidence Interval for the 0.9 quantile value ofTEDE is 2.46E+Ol to 2.50E+01 mrem/year

file:///C:/Program%20Files/DandD2/documents/P-33%20DandD%20Bldg ...

Page I of I

1/21/2015

Page 7: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Rev 1-30-2015

INCYTE CORPORATION

X-STATION

BUILDINGS 336 AND 400

RADIOLOGICAL

FINAL SURVEY REPORT

lncyte Corporation

Wilmington, DE

Prepared For:

lncyte Corporation

December 2014

Revised: January 30, 2015

Prepared By:

RSO, Inc.

Laurel, MD

Page 8: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Rev 1-30-2015

RSO, Inc. • lncyte Corporation • Dupont Experimental Station Buildings 336 and 400 Radiological Final Survey Report

THIS PAGE BLANK

2

Page 9: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

1.0 INTRODUCTION AND RADIOLOGICAL DECOMMISSIONING ACTIONS

1.1 Introduction

lncyte Corporation maintains a Nuclear Regulatory Commission issued byproduct material license of limited scope (07-30728-01). The use of licensed material at the Dupont Experimental Station, Building E336 and E400 in Wilmington, DE has ended and radiological final survey was needed to support removal of this location as an authorized place of use.

1.2 Background-Historical Site Assessment

lncyte began using radioactive material in buildings E336 and E400 in 2003 with regular use continuing through until November 2014. The radionuclides authorized for use are listed in Table 1. H-3 and C-14 have been used; however, of the radioactive materials with half-lives of less than 120 days only P-33 was used in the last 4 years. This use was with non-volatile forms in processes that did not create airborne radioactivity.

Table 1. List of radionuclides listed on license (with data) and recent use.

Authorized Use within 4

Half Life Principle Emission Energy years of the Radionuclides

on-site survey

H-3 12.3 yrs beta 18.6 keV (max)

C-14 5730 yrs beta 156 keV (max)

P-32 14.29 days beta 1.7 MeV (max)

P-33 28 days beta 249 keV (max)

S-35 87.3 days beta 167 keV (max)

1-125 60.1 days photons 27.5-36 keV

(144%) Note 1 last use was 10/6/2005, elapsed time is 3313 days, effectively 100% radioactive decay Note 2 last use was 9/10/2009, elapsed time is 1878 days, effectively 100% radioactive decay

Yes

Yes

No1

Yes

Yes3

No2

Note 3 1 use (ie: benchtop assay) since 11 /03/09 and that was on 3/12/13 in E336/Lab 238, elapsed time is 609 days, effectively 99.2% radioactive decay

The license applications and amendments to this license identified multiple rooms and areas where radioactive materials were to be used or stored.

The laboratory rooms shown in Table 4 were identified as areas authorized for the use or storage of licensed material.

Routine contamination surveys were performed by the licensee during this period of use. No large spills were known to have occurred. Small spills that occurred were cleaned by lncyte personnel.

1.3 Radiological Decommissioning

The use of radioactive material has ended, radiological decommissioning actions taken/completed, and a Radiological Final Survey was performed to allow the release of the building for unrestricted use.

Prior to the final survey all remaining radioactive material was either transferred to lncyte's other authorized location of use, or disposed of as radioactive waste.

Page 1

Rev 1-30-2015 3

Page 10: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

2.0 RADIOLOGICAL SURVEY APPROACH

2.1 Survey Design Basis

This radiological survey was designed in consideration of the guidance provided by the Nuclear Regulatory Commission (NRC) regarding Final Radiological Surveys. In particular the guidance provided by the NRC in NUREG 1757 for what is termed Group 2 facilities (see following excerpt) was used. Group 2 includes facilities that "would not have contaminated work areas at the levels above the decommissioning screening criteria".

From NUREG 1757 v1 Chapter 7:

Group 2 facilities may have residual radiological contamination present in building surfaces and soils. However, licensees are able to demonstrate that their facilities meet the provisions of 10 CFR 20.1402 ("Radiological Criteria for Unrestricted Use") by applying the screening approach dose analysis described in Chapter 6.

Additionally, licensees in Group 2 typically possess historical records of material receipt, use, and disposal, such that quantifying past radiological material possession and use may be developed with a high degree of confidence. Furthermore, these licensees have radiological survey records that characterize the residual radiological contamination levels present within the facilities and at their sites. That is, they are able to demonstrate residual radiological contamination levels without more sophisticated survey procedures (greater than those used for operational surveys) or dose modeling. These licensees do not need to use site-specific parameters or establish site-specific DCGLs in order to demonstrate acceptability for release of their sites."

Derived Concentration Guideline Levels (DCGLs) are radionuclide-specific concentration limits used by the licensee during decommissioning to achieve the regulatory dose standard that permits the release of the property and termination of the license. The DCGL applicable to the average concentration over a survey unit is called the DCGLw. The DCGL applicable to limited areas of elevated concentrations within a survey unit is called the DCGLEMC·

2.2 Decommissioning Criteria

The Radiological Criteria for Unrestricted Use - NRC (10 CFR Part 20)

"A (The) site will be considered acceptable for unrestricted use ifthe residual radioactivity that is distinguishable from background radiation results in a TEDE to an average member of the critical group that does not exceed 25 mrem per year, including that from ground water sources of drinking water, and that the residual radioactivity has been reduced to levels that are as low as reasonably achievable (ALARA)."

2.3 Potential Radionuclide Contaminates and Screening Values

At the time of the survey, the facility was licensed for use of relatively long half-life radionuclides, H-3 (T112 = 12.3 y) and C-14 (T112 = 5730 y) and relatively short half-life (T112

of less than 120 days) radionuclides, S-35, P-33, P-32 and 1-125.

Based on the Historical Site Assessment, H-3 and C-14 and P-33 (T112 = 28 d) were identified as the potential radionuclide contaminates.

The NRC has established Screening Values derived using scenarios and default values for assumptions that result in a Derived Concentration Guideline Limit (DCGL). These values have been derived for common beta-gamma emitting radionuclides for building surface contamination as published in the Federal Register (63 FR 64132, November 18, 1998)

Page 2

Rev 1-30-2015 4

Page 11: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

and also shown in Appendix B Table 8.1 of NUREG 1757 and by definition is the DCGLw. These are values, which can also be derived using the default parameters and the computer code DandD, for the concentration (dpm/100 cm2

) equivalent to 25 mrem/y.

For beta-gamma emitters the DCGLw is typically higher than the facility operational contamination limits. The DCGLw for the potential radionuclides are shown in Table 2.

1 bl 2 DCGL f . I a e w or po ent1a contaminates.

Radionuclide Surface Contamination (dpm/100 cm2)

H-3 *1.2 x 108

C-14 *3.7x106

S-35 *1.3 x 107

P-33 **4.09 x 107

*from NUREG 1757 ** calculated used DandD Ver. 2.1.0

2.4 Performance of Radiological Surveys

The radiological surveys were conducted using guidance provided by the NRC in NUREG-1575, EPA 402-R-97-016, Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM): Revision 1, August 2000.2.5 Survey Design: Area Classification

Impacted Areas

• Impacted areas are areas that may have residual radioactivity from the licensed activities.

• Non-impacted areas are areas without residual radioactivity from licensed activities.

• NRC guidance provides that Final Status Survey (FSS) radiation surveys do not need to be conducted in non-impacted areas.

The impacted area for this license was considered to be the identified laboratory rooms where radioactive material was authorized for use, the radioactive waste storage area, and the connecting corridors.

Classes

Impacted areas can be classified into one of the three classes, listed below, based on expected levels of residual radioactivity.

• Class 1 Areas are impacted areas that, prior to remediation, are expected to have concentrations of residual radioactivity that exceed the DCGLw (DCGLw is defined in Section 2.2 of MARSSIM);

• Class 2 Areas are impacted areas that, prior to remediation, are not likely to have concentrations of residual radioactivity that exceed the DCGLw.;

• Class 3 Areas are impacted areas that have a low probability of containing residual radioactivity.

All areas were treated as Class 3 with no or very limited areas of residual contamination expected.

Page 3

Rev 1-30-2015 5

Page 12: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

2.6 Decommissioning Guideline Levels

The decommissioning guideline levels used for the surveys in are shown in Table 3.

li bl 3 s rf t · d r f r · r d t h F 1 s a e u ace con aminat1on gu1 e mes or 1cense term1na ion use ort e 1na urvey.

Maximum Operational Limit Operational Limit

Removable Total Radionuclide

DCGL (dry wipe method) (scan with survey (dpm/100 cm2)

(dpm/100 cm2) meter)

H-3 1.2 x 108 200 N/A

Not detectable

C-14 3.7 x 106 200 3 x bkg (estimated to be about 2500

dpm)

1.3 x 107 3 x bkg (estimated

S-35 200 to be about 2500 dpm)

4.09 x 107 3 x bkg (estimated

P-33 200 to be about 2500 dpm)

2.7 Survey Units (Areas)

Table 4. lists laboratory rooms or areas where radioactive material was authorized for use (or storage), lab area and the radionuclide(s) used. If the radionuclide used has a T 112 of less than 120 days, "use" is defined as within the 4 years prior to the Final Survey.

Table 4. List of radionuclides listed on license (with data) and use. Laboratory or Lab area

Building location in SQ. ft. C-14 H-3 1-125 P-32 P-33 S-35 1 E336 238 476.1 x x x x 2 E336 266 299.72 x x x 3 E336 268 126.81 x x 4 E336 Dock Cabinet 25 x x x 5 282 Freezer

E336 Farm 25 x x

6 E400 3212 469 x x 7 E400 3214 705 x x 8 E400 3226 705 x x 9 E400 3238 705 x x 10 E400 3403 225 x x 11 E400 3407 705 x x 12 E400 3419 705 x x 13 E400 3474 -600 x x 14 3rd Floor

E400 Corridor freezer 25 x x 15 E400 1440 x x x

Page4

Rev 1-30-2015 6

Page 13: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

Floor plans of each building showing the locations of the laboratory rooms/areas are shown below:

l •

BUILDING E336, SECOND FLOOR H

BUILDING E336, BASEMENT H

Page 5

Rev 1-30-2015 7

Page 14: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Rev 1-30-2015

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

.. • • e 9 •

BUILDING E400, THIRD FLOOR H

BUILDING E400, ARST FLOOR H

Page 6

8

Page 15: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc.• lncyte Corporation• X-Station Buildings E336 and E400 Radiological Final Survey Report

2.8 Survey Number of Samples

Using MARSSIM's guidance for determination of the number of samples needed for a survey unit when the DCGL is large (as is the case for this survey), the relative shift is also large (>2.5), and using equal values of 0.05 for Type I and Type II errors, results in a number of data points needed of 12.

A minimum of 12 samples were collected (per survey unit) using an informal rectangular grid, with a random start point, and additional sample locations selected by the survey team. A scan (floor monitor or hand-held survey meter), direct (static) measurement, and wipe test was performed at each survey location except where noted. Additional sample locations were chosen by the discretion of the surveyor in each survey area including floors, bench tops, cabinets, doors, and sinks to provide additional survey data.

2.9 Survey Methods

The survey methods for each potential radionuclide

Wipe Test for Radionuclide Static/Direct Scan Removable

Contamination H-3 Not practical with survey Not practical with Yes liquid scintillation

meters survey meters Analysis C-14/S-35 Yes - thin window Yes - thin window Yes liquid scintillation

proportional detector proportional detector Analysis P-33 Yes - thin window Yes - thin window Yes liquid scintillation

proportional detector proportional detector Analysis

Beta Scan Survey Surface scanning speeds were 2 detector widths per second. To optimize detection of elevated radiation levels (1.5 to 3 times background) during scanning, audible speakers were used in addition to noting the fluctuations in the analog meter reading. Floor scans were performed using a Ludlum Floor Monitor (Model 2221 survey meter coupled to a Ludlum 43-37 gas flow proportional detector (thin window coated mylar of 0.8 mg/cm2 with an area of 584 cm2

). Scans of other surfaces were performed using a Ludlum Model 2221 with a Ludlum 43-68 probe (gas proportional detector, thin window of 0.8 mg/cm2 with an area of 126 cm2

). Scan survey were conducted on 5 to 10% of the walls and 50 to 90% of the bench tops and floor areas.

Static (Direct) Measurements of Surfaces Static radiation measurements for beta/gamma surface contamination were performed at random (informal square grid with a random start) and biased (sinks, floor drains) locations using a Ludlum Model 2221 with a Ludlum 43-68 detector (gas flow proportional, thin window of 0.8 mg/cm2 with an area of 126 cm2

). Measurements were conducted by integrating a 1-minute count time with the probe in direct contact with the surface.

Removable Contamination A wipe test for removable contamination was performed at each survey location. The wipe

test consisted of wiping a minimum of 100 cm2

of the surface with a dry paper, using moderate pressure and measuring the amount of radioactive material on the test material using liquid scintillation counting (RSO, Inc. Packard TriCarb 3100).

Page 7

Rev 1-30-2015 9

Page 16: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc.• lncyte Corporation• X-Station Buildings E336 and E400 Radiological Final Survey Report

Quality Assurance Survey meters used to perform the Final Survey had been calibrated within 12 months of their use using radioactive standards traceable to NIST. Also, performance checks were completed on each survey meter at the beginning of the survey.

The laboratory instruments used by RSO, Inc. to analyze the wipe tests were maintained under RSO's laboratory quality assurance program which includes a service agreement with the manufacturer, daily quality control performance charts and background and standard samples counted with every sample batch.

Personnel Qualifications All personnel had levels of training and experience commensurate with their assigned tasks. For those individuals involved in taking radiological measurements and samples, special instruction was provided when necessary on equipment, special techniques, and practices relating to survey activities.

Laboratory Services Wipes or swabs were screened for gross gamma activity and further were analyzed for gross beta/gamma activity. All wipes for the final survey were analyzed by RSO, Inc. personnel.

2.10 Data Quality Objectives (MARSSIM)

The survey planning used the Data Quality Objectives (DQO) Process to ensure that the survey results are of sufficient quality and quantity to support the final decision. The use of the DQO Process assures that the type, quantity, and quality of environmental data used in decision making will be appropriate for the intended application. The DQO Process consists of seven steps, as shown below. The output from each step influences the choices that will be made later in the Process.

Rev 1-30-2015

1. State the problem: Radioactive materials (H-3, C-14, S-35 and P-33) primarily in the form of liquids was used in this facility. The use of these materials was strictly limited to work benches and chemical fume hoods in the impacted rooms. It is unlikely that the use of radioactive materials caused residual contamination at levels exceeding the activity DCGL (Derived Concentration Guideline) for H-3, C-14, S-35 and/or P-33. The amounts of radioactivity used at any 1 time was relatively small (millicurie or sub-millicurie amounts) and there were no spills or incidents resulting in widespread contamination ..

2. Identify the decision: Determine if residual radioactivity on structure surfaces of the laboratories and other areas where H-3, C-14, S-35 and P-33 were used with site-specific surface activity DCGLs derived as unrestricted release criteria to comply with dose limits prescribed in 10 CFR 20, Subpart E.

3. Identify inputs to the decision: Radiological survey data was collected for impacted structure surfaces.

4. Define the study boundaries: Historical analysis had identified in Table 4 as the impacted use areas.

5. Develop a decision rule: Given that sufficient data has been collected, if the mean concentration in the facility is less than the DCGL, then the facility is determined to be in compliance with the release criterion. Compliance with applicable DCGLs is demonstrated using the Sign and/or Wilcoxon Rank Sum (WRS) Tests to disprove the null hypothesis that the survey unit being evaluated exhibits contamination at concentrations exceeding the applicable DCGL.

Page 8

10

Page 17: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc.• lncyte Corporation• X-Station Buildings E336 and E400 Radiological Final Survey Report

6. Specify limits on decision errors: MARSSIM's guidance for determination of the number of samples needed for a survey unit when the DCGL is large, the relative shift is large (>2.5), using equal values of 0.05 for Type I and Type II errors, results in a number of data points needed of 12.

7. Optimize the design for collecting data: H-3, C-14, S-35 are low energy beta emitters and P-33 is a "medium" energy beta emitter. Survey equipment and sampling techniques were chosen that were appropriate and sensitive for the detection of the potential contaminates.

3.0 SURVEY INSTRUMENTATION

3.1 Description of Field and Laboratory Instrumentation and Sensitivity (also see Survey Data Sheets)

Field Instrument Used -

Ludlum Floor Monitor: consists of a cart mounted Ludlum Model 2221 with a Ludlum 43-37 probe (gas proportional detector, thin window of 0.8 mg/cm2 with an area of 583 cm2

)

Ludlum Model 2221 with a Ludlum 43-68 probe (gas proportional detector, thin window of 0.8 mg/cm2 with an area of 126 cm2

).

Laboratory Instrument Used -

Packard Tricarb Liquid Scintillation Counter for analysis of wipe tests.

3.2 Description of Instrumentation 1 bl 5 s t d t a e urvey me ers use d t d' I . I o con uc ra 10 0Q1ca surveys.

Survey Meter Detector Detector Probe

Use Model Type Area/Size

Floor Monitor Gas Flow

Ludlum Model Ludlum Proportional 584 cm2 Scans of Floors

2221 Scaler/Rate 43-37 meter

Detector

Ludlum Model Ludlum

Gas Flow Scans of Surfaces 2221 Scaler/Rate Proportional 126 cm2 Direct/Static

meter 43-68

Detector Measurements

3.3 Instrument Calibration and Efficiency Data

The calibration and efficiency data for the survey meters that were used during the Final Survey FS are summarized in Table 6.

1 bl 6 s /' 'b d ff . d a e urvey meter instrument call ration an e 1c1ency ata.

Meter w/ Probe Detector Model Radionuclide Efficiency (47t)

Ludlum Model 2221 Ludlum 43-68 C-14/S-35/P-33 20% cpm per dpm

Scaler/Ratemeter

Ludlum Model 2221 Ludlum 43-37 C-14/S-35/P-33 20% cpm per dpm

Scaler/Ratemeter

Page 9

Rev 1-30-2015 11

Page 18: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

Packard 3H -50% cpm per dpm Liquid Scintillation LS 14C -85% cpm per dpm

Counter 32P -95% cpm per dpm

4.3 Minimum Detectable Concentration for Scanning Technique

Beta Scans:

The minimum detectable concentration for the beta scans was calculated using the suggested method in NUREG-1507 and in Abelquist 2001 (See Equation 9.11 ).

Equation 1

Where:

Scan MDC =estimated minimum activity (dpm/100 cm2) that can be detected

MDCR

p = E; =

during a scan,

= Minimum detectable count rate, see Table 6.6 MARSSIM

surveyor efficiency considered to be 0.25

2n efficiency (c/d)

Es = surface efficiency Note: E; estimated assuming the 2n efficiency was approximately 2 times the 4n efficiency

Note: Es assumed to be 0.5

Table 7. Example of calculation of the MDC for Scanning (scan MDC).

Estimated

Survey Meter Detector or Probe Contami

4rt Eff. MDCR scan MDC

Probe Area/Size nate (dpm/100 cm2

}

Ludlum 2221 Ludlum C-14/S-

Ratemeter 126 cm2 21%* 154 cpm 1,642 Scaler/Ratemeter

43-68 35/P-33

Ludlum 2221 Ludlum C-14/S-

Ratemeter 584 cm2 18%* 1189 cpm 850 Scaler/Ratemeter

43-37 35/P-33

.. *The C-14 instrument efficiency was used for the MDA and act1v1ty calculations as S-35 1s considered to be the same as that of C-14 given the beta energies are nearly equal and the instrument efficiency for P-33 is greater, given the higher beta energy and as demonstrated by the efficiency for Tc-99 {beta energy of 294 keV) shown on the instrument calibration certificates.

4.4 Static Measurement Data Reduction

Determinations of the total surface activity were based on static measurements with the detector in direct contact with the surface. For each analysis gross counts were converted into area activity concentration using the following method of data reduction:

Page 10

Rev 1-30-2015 12

Page 19: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

Where:

A = c = T = Rs = E = a =

Equation 2

A= E*( a ) 100cm2

total activity ( dpm/100 cm2),

integrated gross counts (counts),

count time (min),

background count rate (cpm),

total efficiency (c/d) *source efficiency

detector area (normalized to 100 cm2).

4.5 Minimum Detectable Concentration for Static Measurements

Using the equation shown below the minimum detectable activity for the static measurements was calculated using the following equation for instances in which the background and sample are counted for the same time intervals:

Equation 3

3+4.65/R; Static MDC=---------

K * (detector area) * T. 100cm 2 s+s

Using the equation shown below the minimum detectable activity for the static measurements was calculated using the following equation for instances in which the background and sample are counted for different time intervals:

Rev 1-30-2015

Equation 4 .--~~~~~~~~

3+3.29 Rs *Ts+sO+Ts+~) Static MDC= B

K *(detectorarea) * T 1 O<lsm2 s+s

Where:

Static MDC = activity (dpm/100 cm2),

C = integrated gross counts (counts),

Ts+s =

Ts =

Rs = K =

sample count time

background count time

background count rate (cpm)

proportionality constants e.g.: total efficiency

Page 11

13

Page 20: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc.• lncyte Corporation• X-Station Buildings E336 and E400 Radiological Final Survey Report

T bl 8 E a e f I I . f h MDC f S f M xamp e o ca cu at1on o t e or ta 1c easuremen s.

Detector Probe Efficiency Background Background

Survey Meter Model Area/Size

(cpm per Count Rate and Sample dpm) (cpm) Count Time

Ludlum 2221 Ludlum

1 minute (bkg) Scaler/ 126 cm2 0.21 207 1 minute

Ratemeter 43-68

(sample

Ludlum 2221 Ludlum

1 minute (bkg) Scaler/ 584 cm2 0.18 873 1 minute

Ratemeter 43-37

(sample)

Static MDC (dpm/100

cm2)

528

267

Note: Calculation uses equal count times of 1 minute for background and sample.

3.3 Laboratory Instrumentation Sensitivity

Laboratory Instrument Used - Packard Tricarb 3100 liquid scintillation counter.

The minimum detectable activity for H-3 on a wipe test was estimated to be less than 40 dpm for a 1-minute count time, 1-minute background count time, efficiency of 0.4 cpm/dpm and a background count-rate of 6 cpm.

The minimum detectable activity for C-14 on a wipe test was estimated to be less than 30 dpm for a 1-minute count time, 1-minute background count time, efficiency of 0.8 cpm/dpm and a background count-rate of <15 cpm.

The minimum detectable activity for P-33 on a wipe test was estimated to be less than 30 dpm for a 1-minute count time, 1-minute background count time, efficiency of 0.8 cpm/dpm and a background count-rate of 10 cpm.

4.0 SURVEY RESULTS

The radiological final survey showed residual contamination was less the DCGLs for the survey. Also all measurement results were less than the detection limits for the survey method except for several small areas of contamination. The licensee performed decontamination of these areas and they were resurveyed to complete the Final Survey.

4.1 Survey Results

Attachment A contains the survey results by survey unit. Results include: survey unit drawing annotated with survey locations for wipe tests and direct measurements, and instrument scan results (raw data shown).

Attachment B contains the LSC analysis data print-outs reports.

Attachment C contains the survey meter calibration reports.

4.2 Beta Scans and Direct Measurements-Summary

Final Survey: Small areas (<0.5 m2) of contamination were found during the beta scans.

The levels of contamination found were small fractions of the DCGLw for C-14. lncyte personnel performed decontamination of these areas.

Decontamination included scrubbing with a professional grade cleaner and as needed stripping down the surface material. As observed in Table 9., the techniques applied for removing the contamination significantly reduced the concentration levels in many of the locations. In Table 9., the first column shows the initial sample number before

Page 12

Rev 1-30-2015 14

Page 21: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

decontamination, followed by the resulting measurements. The 5th column shows the corresponding sample number assigned after decontamination had been performed. Sample numbers 263/478, 257/476, 258/477, 393/479,394/480 were re-surveyed and wipe tested. It was determined that the five floor tiles had embedded contamination and were removed. Table 10. lists the pre and post concentration levels for these locations.

"J; bl 9 D A a e econtam1nat1on ttempts

Direct Direct 1 Post

DPM/100 Sam Decon Sample# Area Description 1 min. cm2 (C-14) pie#

min. DPM/100

Count Count cm2 (C-14)

257 Lab 3214, Floor, lile over concrete 869 5488 476 1250 1244

258 Lab 3214, Floor, lile over concrete 1813 2223 477 1111 979

263 Lab 3214, Floor, lile over Concrete 2826 4150 478 2489 3601

393 Corridor, Floor, lile over Concrete 3599 26107 479 2292 3226

394 Corridor, Floor, lile over Concrete 1178 7808 480 1054 871

181 Lab 3419, Shelf.Laminate 711 7867 481 416 1984

211 Lab 3419,Benchtop,Laminate 715 7927 482 332 1349

210 Lab 3419,Fume Hood.Metal 500 4677 483 238 639

134 Lab 3407,Floor,lile over Concrete 2207 15241 484 683 165

Table 10. Post Tile Removal Post lile

Direct DPM/100 Sa mp

Direct 1 Removal Sample# Area Description 1 min. min. DPM/100

Count cm2 (C-14) le#

Count cm2 (C-14)

1 Lab 3214, Floor,lile over Concrete 3052 43992 31 216 560

6 Lab 3214,Floor,lile over Concrete 537 5973 36 207 492

11 Lab 3214, Floor,lile over Concrete 616 7167 41 243 764

16 Corridor, Floor,lile over Concrete 833 10447 46 239 734

21 Corridor, Floor,lile over Concrete 607 7031 51 193 379

4.4 Removable Contamination-Summary

Over 500 wipe tests were collected and were analyzed using liquid scintillation counting. None of the wipe test samples showed any removable activity above 200 dpm.

5.0 CONCLUSIONS

The Radiological Final Survey of the affected areas demonstrates that the surfaces were less than the DCGLw (25 mrem) for surface contamination and no contamination was detected that was greater than the facility operational limits for contamination.

The subject rooms/areas appear to meet the requirements for unrestricted use.

Page 13

Rev 1-30-2015 15

Page 22: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. • lncyte Corporation • X-Station Buildings E336 and E400 Radiological Final Survey Report

6.0 REFERENCES

6.1 USNRC, Regulatory Guide 1.86., Termination of Operating Licenses for Nuclear Reactors, June 197 4.

6.2 USN RC, "Guidelines for Decontamination of Facilities and Equipment Prior to Release for Unaffected Use or Termination of Licenses for Byproduct, Source, or Special Nuclear Material", May 1987.

6.3 NUREG 1757, USNRC, "Decommissioning Process for Materials Licensees", Final September 2003.

6.4 NUREG-1575, EPA402-R-97-016, and Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM): Final, August 2000.

6.5 10CFR Part 20 § 20.1402 Radiological criteria for unrestricted use.

6.6 Abelquist, Decommissioning Health Physics, A Handbook for MARSSIM Users, IOP Publishing Ltd 2001, Philadelphia PA.

7 .0 ATTACHMENTS

Attachment A

Attachment B

Attachment C

Rev 1-30-2015

Radiological Survey Results

Wipe Test LSC Analysis Report Print-Out

Survey Meter Calibration Reports

Page 14

16

Page 23: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RADIOLOGICAL SURVEY RESULTS

Rev 1-30-2015 17

Page 24: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc e Building: Building 336

Meter1 Meter2 Meter3 Date: 11/10/2014 Not In Service 11/10/2014

Make: Ludlum Ludlum Model: 2221 2221

SN: 161591 89650 Probe Make: Ludlum Ludlum Probe Model: 43-68 43-37

Probe SN: 118227 148928 Probe Area (cm'): 126 584

Next Cal. Date: 11/7/2015 6/14/2015 Backoround Surface Material Laminate Tile over Concrete Backaroundfc) - TimefMin)): 2066 10 8729 10

CS lsotooe - Activitvl,,Cil: C-14 0.159 C-14 0.159 CS Sourcelcoml 8443 8770

L,. Ld (Counts) 3:3 70 69 140

Direct MDC, Scan MDC

(dpm/100cm2i 528 1642 267 850 MDCR(gross), MDC (gross)

Count Rate 360 262 1189 897 Total Efficiencv, lsotooe: 10.5% C-14 9.0% C-14

Source Efficiencv 0.25 0.25 Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*ct*A*C

MDCR

s,. (60/i)

Lab/Room: 238 ,266

Meter4 Meters Not In Service Not In Service

uRem/hr

NA NA

NA NA

NA NA

NA

B = Background Counts T = Counting Time In Minutes c1 =Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm' C =Other Constants and Factors When Needed Ehr = Human Factor Efficiency c, = Source Efficiency s, = 1.38.SQRT(B,)

i = Counting Interval

18

Page 25: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Example of Survey Meter Calculations of MDCR, Scan MDC, and Direct MDC

Meter 1 Scanning Sensitivity Date: 11/10/2014 MARSSIM Value Description

Make: Ludlum MDCR Calculation Model: 2221 d' 1.38 detectabilitv value associated with the desired performance

SN: 161591 i 1 interval Probe Make: Ludlum b; 3.443 bi=background counts in interval=B*(1/60)

Probe Model: 43-68 s, 2.56 si=d'*SQRT(bi)

Probe SN: 118227 MDCR(net 154 MDCR(net)=Si*(60/i Probe Area (cm2

): 126 MDCR (qross) 360 MDCR(qross)=Si*(60/i)+B

Next Cal. Date: 11/7/2015 Scan MDC Calculation Backqround Surface Material Laminate p 0.5 Survevor Efficiencv Ehf or Efficiencv human factor) BackQround(c) - Time(Min)): 2066 10 Source Efficiency 0.25

CS Isotope - Activitv(mCi): C-14 0.159 Meter efficiency from Cal 0.21 CS Source(cpm) 8443 e; 0.105 Meter Efficiency from Cal * 2(2Pi factor) * Source Efficiency

L,. Ld (Counts) 33 70 e, 1 Surface Efficiency (decreases for porous surfaces) Direct MDC, Scan MDC

(dpm/100cm 2) 528 1642

MDCR (gross) , MDC (gross) Scan MDC 1642 Scan MDC= MDCR(netl

SQRT(Eh1)*e;*e5 *A *C Count Rate 360 262

Total Efficiency, Isotope: 10.5% C-14 Direct MDC Calculation Source Efficiency 0.25 B 207 B = BackQround Counts

T 1 T = Countina Time In Minutes

Direct MDC 528 Direct MDC= 3+4.65*SQRT(B)

T*etA*C

Rev 1-30-2015 19

Page 26: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11 /10/14 ~~~~~~~~~~~-

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200

Building: Building 336 Lab 238

Finish Date: 11/10/14 -------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross P Average dpm/100

(cpm) cm2 (C14)

20

Page 27: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11 /10/14 ~-----------

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Wi e Tests

j3 j3 j3 (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Building: Building 336 Lab 238

Finish Date: 11/10/14 -------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross j3 Average dpm/100

(cpm) cm 2 (C14)

21

Page 28: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

5 -10 -~

.... "'"

4 .... .... "" "' lA8238

3 .... 9 U1

8 N N 0 ....

.... "'

I CD ::E .... !Z ~ °' 2 :00:

.... 25"

I ... 00

"' I"" "' 2 I"'" ....

I N .... ....

~ I "" l:: N r; 0 U1 "" 1::::

I N

°' 6 I I N "" 00 .... 1 21" I

7 ll:: I/ "" \ L N -11 on do~·

CABINET UNDER FUME Ht,; FUME HOOD

-Rev 1-30-2015 22

Page 29: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/10/14

Building: Building 336 Lab 266

Finish Date: 11/10/14 ------------ -------Surveyor: Korreesa Williams Surveyor: Matthew Mueller

Area Surve Results Wi e Tests Direct Measurements

Wipe Number

59 60 61 62 63 64

Rev 1-30-2015

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

Description

H-3 C-14 High E

Floor Tile Over Concrete <200 <206 <200 Floor Tile Over Concrete <200 <200 <200 Floor Tile Over Concrete <200 --<:100 <200 Floor Tile Over Concrete <200 <200 1--<-2'"'0,_0---1

Floor Tile Over Concrete <200 <200 <200 Floor Tile Over Concrete <200 <200 <200 Floor Tile Over Concrete <200 <200 <200

;Floor Tile Over Concrete -----<2off- ---:;:-2-60- - <200 Floor Tile Over Concrete -- --:;:;1Q-6 <200 ... , -<-2-00-.. I Floor Tile Over Concrete <200 <260- - <200

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Door Metal <200 <200 ... , -<-2-00_..__ - -----+B-e_n_c_h_T_o_p_L_a_m-in-a-te-+------:;:250 <2oo <200

1Shelf Laminate <200 <200 <200 Shelf Laminate <200 - I <2oo <200 Bench Top Laminate <200 t--~~OQ- <200 Door Metal -- <200 I <200 +-, _<_2_0_0--+

I Bench To <200 _ r- <?:QQ .,__<_20_0_ .. ___ _

1 Bench To Laminate ~1g§-+-~§~ :~~~ I Bench To Laminate <200 I <200 <200 1Drawer Metal - <26o 1 =-~?o()__ <200 I Cabinet Under Hood Metal <200 I <200 ,.__<_2_0_0--+

!Sink Laminate <200 l- <200 <200 Sink Laminate <200 ' <200 <200

1Sink Drain Metal <200 l <200 <200 I Fume Hood Laminate ----<260-- j <2-66 <200 !Fume Hood Laminate <-256 --'r- <200 <200 iFume Hood Laminate _<:?QQ __ ! <200 <200 1 l_Fume Hood_ Laminate <200 <260 +--<"""2-::-o""o--ti

Scan Measurements

Gross High

(cpm)

Gross P Average dpm/100

(cpm) cm2 (C14)

4 4

I 51 -""t 51

J 51 - 5i

23

Page 30: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1_1_11_0_11_4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1·30-2015

Description

j Fume Hood Right Wall Laminate

Fume Hood Left Wall Laminate

Fume Hood Back Wall Laminate

Fume Hood Cover Laminate

Fume Hood Lip Laminate

J ~~.me bi?_C:9V~VT Laminate

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 <200

i-·-~~61 i <200 ··<200 ...

I <200 <200 I <200 <200 <200 ····t·<-266 <200 <200 L~?oCi <200

Building: Building 336 Lab 266

Finish Date:_1;..;1.;../1.;..;0;.;./_14 ___ _

Surveyor: Matthew Mueller

Direct Measurements

Survey Gross Meter# (cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

24

Page 31: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

~1111111111111111111111111-r .......... ~ .. lll! .... ~68:--~FU~M~E~H~O~IOllf"~"'----., ........ 64 65 66

WORK BENCH

_......, ......................... ...J~l~ ............ ~~62~~~...:63~Jl~6~1~1~"'-~.a. .... ..1 .... 1 r CABINET UNDER

LJ-1.Q~-----!~---~~----~~--

54

44 J 51 on door 43 42 52 53

46 on door

Rev 1-30-2015

"' "' "' 0.f 41 40

~

36 19"

37

60Fl~ w so

lA8266

47

49

39

48

38

- 1811 __ _

..-----------................................ 1...--25

Page 32: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc e Bu'tlding: _3--3-'-6'-,4--0-'-0-------'L;.;;a;.;;b--/R--o"'o""m-'-:-'2;.;;6--8._,2_8_2._,D_e __ c_k'-,3-4-'-0-7,'-3_4_19'-

Meter 1 Meter2 Meter3 Meter4 Meters Date: 11/11/2014 Not In Service 11/11/2014 Not In Service Not In Service

Make: Ludlum Ludlum Model: 2221 2221

SN: 161591 89650 Probe Make: Ludlum Ludlum

Probe Model: 43-68 43-37 Probe SN: 118227 148928

Probe Area (cm<): 126 584 Next Cal. Date: 11/7/2015 6/14/2015

Backqround Surface Material Laminate Tile over Concrete Backqround(c) - Time(Min)): 1906 10 8349 10 uRem/hr

CS Isotope -Activitv(uCi\: C-14 0.159 C-14 0.159 CS Source(com 7949 6194

L,. Ld (Counts) :12 67 67 137 NA NA

Direct MDC, Scan MDC

(dpm/100cm2 508 1578 261 831 NA NA

MDCR , MDC Count Rate <138 244 1144 858 NA NA Total Efficiencv, lsotooe: 10.5% C-14 9.0% C-14

Source Efficiencv 0.25 0.25 NA Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*t:1*A*C

MDCR

s,. (60/i)

B = Background Counts T = Counting Time In Minutes c1 =Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm2

C = Other Constants and Factors When Needed Ehr= Human Factor Efficiency "' = Source Efficiency s, = 1.38'SQRT(B,)

i = Counting Interval

26

Page 33: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/11/14 ------------Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

87 88 89 96 ..... ~Ji

92·· 93 94 95

Rev 1-30-2015

Description

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Laminate Laminate Laminate

Bench Top Laminate Drawer Metal Bsc Cabinet Metal Sink Drain Metal

1Sink Basin Metal Cabinet Below Sink Metal Fume Hood Base Metal Fume Hood Base Metal

I Fume Hood Base Metal Fume Hood Left Wall Metal Fume Hood Back Wall Metal

Fume Hood Back Wall Metal

!Fume Hood Right Wall Metal

i Fume Hood Cover Laminate

•Fume Hood Lip Metal

[F~~E! f1()o~.i:i£ .•.. ~.E!t.f!I

Wi e Tests

J3 J3 J3 (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 r <200 <266 <200 <200 t ·:;:200

<200 ··t·<200 ··<200··

),µµµµµ_, """~~~""~"~

I <200 <200 1·<200· <200· l <266 <200 r·<200 <200 I <200

·<200 r·· <200 <200 r <200

··<2oa·T <200 l

············-~ + <200 : <200 l

<260 l .. <206 l

<200 4 .. <200 ·<206 I <200 I

<200 l <206 I

<200 -+ <200 <200 .L <200 <206 I ·.::255·

<200 t <200 <200 r <200 l

I <·206 ·- I <200 <200 µ t" <200

...

1 <200

Building: _4_0_0 __ Lab/Room: 268

Finish Date: 11/11/14 --------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross Average

(cpm)

J3 dpm/100

cm2 (C14)

27

Page 34: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

I 81 drawer I ~85 I 79

75 73

LAB268

-- 12" --74

CABINET UNDER HOOD

r-~-------~~---------~----1 79

88 87 86

92 91 90 89

10"

72 77

93

Rev 1-30-2015 28

Page 35: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1_1/_1_1/'-1_4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E ddUd•-VV~-··--•vv

<200 <200 <200 <200 <200 <200 <200 I <200 <200

--<200-1 <200 <200 ··:::2aa·r~<2aa·····- <200 ~~~~QQ ~- -~QQ- <200

<200 I <200 <200 -~VU~U-~ VV>VrVm~VVU-VUU-VVUUv-vVU

<200 <200 ' <200

-=~v~~ <200 <200

<200 <200 <200 <200 -- ·<200 <200

--<200-1--<200 <200 ·:.:200 t . <200 ' <200

_ ~?QQ~j =- ~<?oo::. <200 <200 I <200 <200

:~~~rt=-~~~---<200 <200

<200 I <200 <200 . <2:Q2.1··· <200· <200

Building: -'4..;..00.;;...__Lab/Room: 282

Finish Date: 11/11/14 --------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Meter# (cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

29

Page 36: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

38"

- 30"

112 113 114 110 111

107 108 105 109 106

101 COMPOUIND STORAGE 282 100 102 104 103

99 98

96 97

STORAGE

Rev 1-30-2015 30

Page 37: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/11/14 -----------Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Concrete Concrete Concrete Concrete Concrete

Metal Metal Metal

Metal Metal Metal

Cabinet Shelf Metal Cabinet Shelf Metal Cabinet Wall Metal

.1C:::."32i.f1Ejti:)()()! Metal

Wi e Tests

13 13 13 (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 <200 <20<r <200 <200

··.::200 <200 <200 <200 <200 <200

·<200· ~<200 ·····<200···· <200

<200 <200 <200 <200

Building: _4_00 __ Lab/Room: Deck Area

Finish Date: 11/11/14 -------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross 13 Average dpm/100

(cpm) cm2 (C14)

31

Page 38: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

116

120

119

117

126 127

128 129 CABINET

Rev 1-30-2015 32

Page 39: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/11/14 -----------~

Surveyor: Korreesa Williams

Area Surve Results Wi e Tests

13 13 13 Wipe

Number Description

(dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Floor Tile Over Concrete <200 Tile Over Concrete <200 Tile Over Concrete <200 Tile Over Concrete ·<200·

""~"-"~"--··-"--

Tile Over Concrete <200 Tile Over Concrete <200 Tile Over Concrete <200 <200 Tile Over Concrete <200 <200 Tile Over Concrete ···:;:250·· <266 Tile Over Concrete <200 <200

Metal <200 <200 Vacuum Filter Metal -·:;:2·55····- <200

Laminate <200 ··~-··-··---····-

Laminate <200 Laminate <200 Laminate <200

Bench To Laminate <200

··------·-··--····-·- Bench Top Laminate ----<2oo· Bench Top Laminate <200 Sink Drain Metal --<2oo· Sink Metal <200

<200 <200 <200

<200 . <200 ··1-:"'.""".,....,:-----:""."'""-,---t····· <200 t. <200

<200 r <200

Under Sink Metal Sink Drain Metal

I Sink Basin Metal .Under Sink Metal <200

Building: _4_00 __ Lab/Room: 3407

Finish Date: 11/11/14 --------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

t--

Gross High

(cpm)

Gross Average

(cpm)

13 dpm/100

cm2 (C14)

<200 t· r·· 224 t ·t + 15()_j -307

<200 . L_::~Q.o <200 I <200 t---:=,..-+· :· 'Sink Drain Metal

157 Sink Basin Metal 158 Under Sink Metal 159 JUnder Fume Hood Metal

Rev 1-30-2015

<200 - t·. <200 ... }

<200 f <200 <200 <200

<200 <200 <200

173 151 156

·f·· -133 I 224 -299 t 224 +- 224 -262 i

J 150 J. I 150 i-

150

-307 -307 ~367

33

Page 40: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1c..;1;..;/1;..;1;..;/1'-4 _______ _

Surveyor: Korreesa Williams

Area Surve Results Wi e Tests

Wipe Number

p p p

Description (dpm/100 (dpm/100 (dpm/100

cm2} cm2

) cm2)

H-3 C-14 High E

'Door Metal <200 Fume Hood Base Metal <200 Fume Hood Base Metal <200 Fume Hood Base Metal <200 Fume Hood Wall Metal ---<266--Fume Hood Back Wall Metal <200

'"!Fume Hood Back Wall Metal "~""""'<200 v-·

Fume Hood Right Wall Metal ···"~<2Qo" Fume Hood Cover Metal <200 Fume Hood Lip Metal <200

£'~!11~~0<>,cl._l,:ip_~e~~I <200

Building: 400 Lab/Room: 3407

Finish Date: -'1;...;1.;../1;..;1;.;../1"'-4'----­

Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross Meter# (cpm)

dpm/100

cm2

(C14)

Survey Meter#

Gross High

(cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

Rev 1-30-2015 34

Page 41: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

CJ

r--I-" I

0 I.!: I Ill I:: I ... I~ I

143

I § I 134 137 I; I D,.. 1·!: I

146

I~ I I u I IN I 1"' I

140 ,.. I

I I :::c: L- .. u z D w CID ::ii::: 133 a:: 0 3:

-:-.!:I ::1

~· 149

§I

144 ;I .!:I

~· 147

ul 136 148

"'I :!l1 139

1132 I

a:

L-J ...

N !::::; <:I' - ZS" ... u.. LAB 3407

!!:

135 138 --29.s·- 131

Rev 1-30-2015 35

Page 42: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1_1_11_1_11_4 _______ _

Surveyor: Korreesa Williams

Area Surve Results Wi e Tests

Wipe Number

p p p

Description (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Tile Over Concrete <200 ! <200 <200

~ ......... : .. =--=··· .... .,_ ___ T_ile_o_v_e_r _co_n_c_re_te+·:=~~QQ~~·r: .. ~~O. .... :t--_<_2_0_0--t Tile Over Concrete <200 I <200 <200 Tile Over Concrete ·····:z200 . r· . <2(j"c)' .. <200

Building: ...;.4.;;..00;;...__Lab/Room: 3419

Finish Date: ...;1...;.1...;./1...;1.;../1'-4;...._ __ _

Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

·+ ................. ·t---...,,-:-:---t·"C ........... . Tile Over Concrete <200 ! <200 <200

Rev 1-30-2015

·+ ....................... 1-----..;...;..--t Tile Over Concrete <200 I <200 <200 Tile Over Concrete .... <2ao· .. ,. <200 <200

Floor

Floor

, Floor Tile Over Concrete <200 <200 <200

<200 <200

<200 <200

<200 <200

36

Page 43: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1_11_1_1/_1_4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Description

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 !-----------+-~~~~~~~+.

Rev 1-30-2015

Metal <200

--+---"-----+- <200 <200 <200 --<2ocr

-1-=----=~~~....,...~-+ <200

Building: _4_00 __ Lab/Room: 3419

Finish Date: _1_1'-/1_1.;../1_4 ___ _

Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross P Average dpm/100

(cpm) cm 2 (C14)

37

Page 44: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

~ -...

I EJ I I I

fl' ~: ~· &. 177 ·;;;1 180 ~1

~· ~ ~. -01

174 §I §1

-· 'WI , .~. .!:I .c1 ~· ~ G1 ua

"' ..... g:, I ..... "'• .....

"' .... , ... ..... ..... 00 00 • .... I

..,. .... ... --· "' w

"' ""' :i:: ..... .... ..... "' w N ..., 111

.... 00 00

.... ..... .... ..... 00 00 179 "' "'

N

~ m ml .... 176 N N

"'

173

lA83419

172 175 178

171 on door

Rev 1-30-2015 38

Page 45: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc e Building: _3_3~6,~4_00 _______ L_a_bl_R_o_o_m_: _3_2_1_2~, 3_2_1_4~, _32_2_6~, _34_0_0_

Meter1 Meter2 Meter3 Meter4 Meter5

Date: 11/12/2014 Not In Service 11/12/2014 Not Jn Service Not In Service

Make: Ludlum Ludlum

Model: 2221 2221 SN: 161591 89650

Probe Make: Ludlum Ludlum Probe Model: 43-68 43-37

Probe SN: 118227 148928 Probe Area {cm'): 126 584

Next Cal. Date: 11/7/2015 6/14/2015 Backaround Surface Material Laminate Tile over Concrete Backaroundlcl - TimelMin)): 1430 10 6446 10 uRem/hr

CS Isotope - Activity(µCi): C-14 0.159 C-14 0.159

CS Source(cpm' 8453 5935 L,. L, (Counts) 28 59 59 121 NA NA

Direct MDC, Scan MDC

( dom/100cm2 443 1366 230 730 NA NA

MDCR , MDC Count Rate 271 190 916 665 NA NA Total Efficiency, Isotope: 10.5% C-14 9.0% C-14

Source Efficiencv 0.25 0.25 NA Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*£1*A*C

MDCR

s,. (60/i)

B = Background Counts T = Counting Time In Minutes c1 =Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm2

C = Other Constants and Factors When Needed Ehr = Human Factor Efficiency c, = Source Efficiency s, = 1.38'SQRT(B,)

i = Counting Interval

39

Page 46: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/12/14 ~----------~

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Description

Sink Drain Metal Sink Drain Metal Cu Sink Laminate Cup Sink Laminate Bench Top Laminate Bench Top Laminate Bench Top Bench Top

i Fume Hood Base Metal Fume Hood Lip Metal

Metal

Fume Hood Left Wall Metal

Metal

Fume Hood Base Metal Fume Hood Lip Metal Fume Hood Right Wall Metal

Fume Hood Left Wall Metal

Metal

Wi e Tests

f3 f3 f3 (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 ·-·-~··- "'

<200 <200 <200 <200 <200 <200 <256- <206-

<200 <200 <200

--<-200 <200 ····-· -·•mm-mm~'''

;Fume Hood Left Wall Metal <200 -i .. <200 "'""1 D-o-. o-.. r __ M_e_t_a_I ----1····- <206 I <260

Rev 1-30-2015

Building: _4_00 __ Lab/Room: 3212

Finish Date: 11/12/14 --------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross Average

(cpm)

f3 dpm/100

cm 2 (C14)

40

Page 47: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/12/14 ------------Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

iFloor Tile Over Concrete

1Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

!Door Tile Over Concrete

)Cabinet Under Hood Metal

!cabinet Under Hood Metal

Shelf Laminate g;~E)lf Laminate

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Building: _4_0o __ Lab/Room: 3212

Finish Date: 11 /12/14 --------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Meter# (cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

41

Page 48: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

N en M N N N

247

Rev 1-30-2015

251 on door

LAB3212 <·'/If.)

246

245

42

Page 49: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: ...;1...;.1;...;/1..;;;2;...;/1'-4 _______ _

Surveyor: Korreesa Williams

Area Surve Results Wi e Tests

Wipe Number

Rev 1-30-2015

p p p

Description (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Tile Over Concrete - -----:.::-20()" -Tile Over Concrete <200 Tile Over Concrete ---<206- --Tile Over Concrete <200 Tile Over Concrete -----<2Q(j"

Bench Top Laminate Bench Top Laminate Bench Top Laminate Bench Top Laminate Bench Top Laminate

Building: _4_00 __ Lab/Room: 3214

Finish Date: 11/12/14 -------Surveyor: Matthew Mueller

Direct Measurements

Survey Gross dpm/100 Meter# (cpm) cm2

Gross P Average dpm/100

(cpm) cm2 (C14)

43

Page 50: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: ""'1""'"1'"'/1.;;2'-'/1'"'4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Wi e Tests

13 13 13 {dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Building: _4_0_0 __ Lab/Room: 3214

Finish Date: -'1_1_11_2_/1_4 ___ _

Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Meter# (cpm) cm2

I

Gross Average

(cpm)

.LI~9J L 180 :

13 dpm/100

cm2 (C14)

280

44

Page 51: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

l.A832l4 20"

263 259 257

[] 25"

264 [] [!] 260 [!] ~ [!] m co N .... N N

N co 00 ..... 00 N 0 00 N

258 .,., " N N

00

265 .I>

261

1!::! 111

In w

.~ "' N I;; .....

277 " .I>

·~

Rev 1-30-2015 45

Page 52: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1_1/_1_2'-/1_4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Description

Wi e Tests

ll ll ll (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 ·c-~c-----1----.,.----..,..-+- <200 <200 <200

328 329

Rev 1-30-2015

<200 -------··a- <200 ---+--------t----------------

<200 <200 <200 ---<200 <200 <200

+--------~-- <200 <200 <200

<200 <2oo , <200 <200 <200

<200 <200 <200- <200

Building: -'4..;;.00.;;,..__Lab/Room: 3226

Finish Date: -'1_11_1_2_/1_4 ___ _

Surveyor: Matthew Mueller

Direct Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Scan Measurements

Gross High

(cpm)

Gross ll Average dpm/100

(cpm) cm2 (C14)

46

Page 53: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: _1_1_/1_2_11_4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Building: 400 Lab/Room: 3226

Finish Date: _1'""'1.;../1""2""/1.;..4""---­Surveyor: Matthew Mueller

Direct Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Scan Measurements

Gross High

(cpm)

Gross P Average dpm/100

(cpm) cm 2 (C14)

47

Page 54: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

[:]

Rev 1-30-2015

LAB 3226

308

309

310

0 0

29.5"

305

306

I~ I~

C1/

I~ 307 I~

C" .... 16- .....

ID

I~. " I.""

301

302

25"

cu 303

.... N

""

"' ::c m .... 'Tl

-" 1 ~I ~I Cl/

-::1 ..... Cl/

.... ]I 304 "' :31 00 ;ril

48

Page 55: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/12/14 ~~~~~~~~~~~-

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Floor Metal Floor Laminate Floor Laminate Floor Laminate Floor Laminate Cu Sink Metal Sink Drain Metal Under Sink Metal Cabinet Under Hood Metal

Laminate

Wi e Tests

fl fl fl (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Building: 400 Lab/Room: 3403

Finish Date:-'1-'-1/-'1""'2/'""'1_4 ___ _

Surveyor: Matthew Mueller

Direct Measurements

Survey Gross dpm/100 Meter# (cpm) cm2

Gross fl Average dpm/100

(cpm) cm2 (C14)

49

Page 56: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/12/14 -----------Surveyor: Korreesa Williams

Area Surve Results Wi e Tests

p p Wipe

Description (dpm/100 (dpm/100

Number cm2) cm2

)

H-3 C-14

Rev 1-30-2015

p (dpm/100

cm2)

High E

<200

Building: _4_00 __ Lab/Room: 3403

Finish Date: 11/12/14 -------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Gross Gross p Survey Gross dpm/100 Survey

High Average dpm/100 Meter# (cpm) cm2 Meter#

(cpm) (cpm) cm2 (C14) (C14)

50

Page 57: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

335 co -"'

·~ I q-Q; I rt')

"'C

w w U1 U1

~

§ I

w tJ I c::

:g I ~I

N ~, q-rt')

334 [j] rt')

w ~

q-rt')

~

333 0 U) rt') w

~ 0

25" 332

331 I LAB3403 ~ 10" -

350 on door

Rev 1-30-2015 51

Page 58: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc e Building: _4_0_0 ________ -'L'"'a""b'"'/R __ o'-'o-'-m--:----'3-'4'-74-','-C-o_rr_id_o __ r.'-3-23_8 __ _

Meter 1 Meter2 Meter3 Meter4 Meters Date: 11/13/2014 Not In Service 11/13/2014 Not 1n Service Not In Service

Make: Ludlum Ludlum Model: 2221 2221

SN: 161591 89650 Probe Make: Ludlum Ludlum Probe Model: 43-68 43-37

Probe SN: 118227 148928 Probe Area (cm'): 126 584

Next Cal. Date: 11/7/2015 6/14/2015 Background Surface Material Laminate Tile over Concrete BackQround(c) - Time(Min)): 1450 10 5866 10 uRem/hr

CS Isotope -ActivitvfaCi\: C-14 0.159 C-14 0.159 CS Source(cpm) 8298 4899

L,, Ld (Counts) 28 59 56 116 NA NA

Direct MDC, Scan MDC

(dpm/100cm2\ 446 1376 220 697 NA NA

MDCR , MDC Count Rate 2l4 192 845 606 NA NA Total Efficiency, Isotope: 10.5% C-14 9.0% C-14

Source Efficiency 0.25 0.25 NA Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*c1*A*C

MDCR

S; • (60/i)

B = Background Counts T = Counting Time In Minutes c, =Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm2

C = Other Constants and Factors When Needed E"' = Human Factor Efficiency c, = Source Efficiency s, = 1.38'SQRT(B,)

i = Counting Interval

52

Page 59: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/13/14 ------------Surveyor: Korreesa Williams

Building: _4_00 __ Lab/Roon 3474

Finish Date: -'1-'1'-/1'"'3"'""/1'-4'"---­Surveyor: Matthew Mueller

Area Surve Results Wi e Tests Direct Measurements Scan Measurements

Wipe Number

Description

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

:~66 +--:~66--t--=-,~=-=6..,,6--+··:······--··-·-· +· -'·=·='·~--·'=-=·":-- E· t·-.. ·-·;::·;:::;::-- --·+----'---------+· "<2c)i)' + <2-50+---<2..;..0...,;0---1---···-·----·+-··''c.::. .. f.. ........ c: .• : .. : .... .

Floor Tile Over Concrete

Floor Tile Over Concrete

I- ···---···-~·----+-'--+-"-'-;...;....;;..;;.;.;.;...;;."-l-~"'~<;;;.2~::..;;.00.:_t=~:QQ: :.1--_<;;;.20;;_0;..._i.: .... " "''""' ..,.._;:;,;,;,,,,,,,J. .......... .:.:::..: ...... . <200 I <200 <200 ··--··t---------+-· .. -· .. -+ ............ - ... -.. 1-----I·:····-·--····-?·-·:

, ............ :.....:. ............. ..;..;.c__;~.;;_;_;.;....;;.""";..;;..;.;;""-... <.:.:2=0Q, _j....._:"?_QQ_ .,.__<_2_0_0__,, ... ,,,,, .. ,,,,,,,,,,,,,,_,.,,,,,,,,,, .. +

... ·l~-------+~<_2_0~0. I <200 <200 r---·;::"';."' :"?.QQ:1::<~2g: <200

<200 ' <200 t---<2"'0=-=o,......-1r·:

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete <200 <200 Door Metal <200 <200 Bench To Laminate ""<2oa· <200 <200 Bench To Laminate -<200 .... ·· ·;;:;foa·-+--<""2"""00"'-~ Shelf Laminate <200 <200 <200

"""""""""""-""" ~-µ~µ-µ

Shelf Laminate <200 1 <200 <200 Hvac Unit Metal ...... «266'1" <200 <200 Bench To Laminate ...... «2oo- .. r <200 <200

''';'.;;:;:;:- "''t,..--,-=-"'--:----:--t-" ·-·~ ....... ,,4

........ ~-:-'":-.. ~~.;..~-... -~"""~ ..... ~.-. .;;;~.;;.;:;...~;.;;:~.;.;:;;..;:.;;.:i.. :~~~ t :~~~l-.--:-~-~-~--+-- ""

Rev 1-30-2015

Gross High

(cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

53

Page 60: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

DO .... rt'l

.... .... rt'l

Rev 1-30-2015

379

368

369

370

ROOM3474

365

366

367

380 SHELF

I :~~c •mj;11.,. __ 3_74 ________ 3_1_s ___ _

361

362

363

364

w ..... N

w ..... w

54

Page 61: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: -'1-'-1/'"-'1-"3'""'/1--4 _______ _

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Description

Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Tile Over Concrete

389 Floor Tile Over Concrete

--·-39() Floor Tile Over Concrete

391 'Floor Tile Over Concrete

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm 2

) cm2)

H-3 C-14 High E

392 Floor Tile Over Concrete ----·. 393· -·- l-F-10""'0-r _T_il_e""'o-v-er_C __ o_n-cr-e-te+·----·=c:::=---ct----=C:.~

394 Floor Tile Over Concrete

3iJ"5 Floor Tile Over Concrete

396 Floor Tile Over Concrete

397 'Floor Tile Over Concrete

398 -Floor Tile Over Concrete

399 Door Metal 400 J Door Metal

Rev 1-30-2015

Building: 400 Lab/Room: Corridor

Finish Date: -'1-'-1/'"-'1-"3--/1'""'4~---­Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

55

Page 62: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

LAB 3401 ~99ondoor

398 LAB 3204 392

397

LAB 3403 396

LAB 3212 393

395 LAB 3407 394 LAB 3214

LAB 3413 391 LAB 3220

LAB 3419 LAB coAl100R 389 LAB 3226

388 LAB 3425 LAB 3232

387

386

385

384

LAB 3431 LAB 3238

383 LAB 3437 LAB 3244

382

LAB 3443 LAB 3246 381

N,.ooondoor

Rev 1-30-2015 56

Page 63: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11 /13/14 ~~~~~~~~~~~~

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Description

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Floor Tile Over Concrete

Tile Over Concrete

Laminate Laminate

Sink Laminate Sink Laminate

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm 2

) cm2)

H-3 C-14 High E

<200 Cabinet Under Sink Metal <200

-- ·-·--422---·- Cabinet Under Hood Metal ···-- <200 __ _ 423 Cabinet Laminate <200 <200

-424 Benchtop Laminate -<2oo - <266 425 I Shelf Laminate · <200 <266

"""""""'~-'~"'""""

426 I Bench Top Laminate <200 <200 427 Shelf Laminate <200 <200 428 I Bench Top Laminate ~~26-Q= <26-6 429 !Shelf Laminate <200 <200

Rev 1-30-2015

Building: _4....;0....;0 __ Lab/Room: 3238

Finish Date: _1_1_/1_3_/1_4 ____ _

Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross Average

(cpm)

p dpm/100

cm2 (C14)

57

Page 64: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/13/14

Building: _4_00 __ Lab/Room: 3238

Finish Date: 11 /13/14 ~----------- --------

Surveyor: Korreesa Williams Surveyor: Matthew Mueller

Area Surve Results

Wipe Number

Description

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

Metal <200 , <200

Direct Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

.... ---~--M-e-ta"""'1 l-·-:::2aa·T <2oo Meta1 <200-r<200-- +-----+-·-···-·

1---·--·C,O.:C. .•••• -+---------+······-··--· ·+ ... ,,,_,, ... !----,,..,,..,,.-+·• Metal <200 I <200 '

·+------M-e-1a-+1 ·<200 t ·<200· +----+··············· f ............ .;:,=... .,,,,_,,,., _,

·+-----~M_e_t_a1 .. <200 I <200

~ ·-········c-"'····· ···+-------~-:-::-!: -~j~~~- + -=~~~ Metal <-2-66 ·· ·1 ·:;:·200 - I

+-------M-e-ta-11 .. <2oo T <200 ;------+····

·-~:...::..::..:.::..:..:.::.::.::...=__:_:M:.:e~ta:::..fl <200··1 <200 Hood Base Metal <200 <200

Fume Hood Wall Metal <200 I <200 Fume Hood Wall Metal <200 l <200 Fume Hood Wall Metal <200

"''"t'"' <200

... tf'LifT1~-f:l()()d Li£l. .flA.e.t(ll ··<200 <200

Rev 1-30-2015

Scan Measurements

Gross High

(cpm)

Gross P Average dpm/100

(cpm) cm2 (C14)

58

Page 65: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Q 0 0 :c

~ ::> ...

Rev 1-30-2015

408

409

410

LAB3238

:E 0 "' :><: m

1re !t ,_. n In :c

.~

·~ ·~ I ~I ·~· ,..

~ ... :c "'

00 N <:j'

29.S"

406

405

,. ......

25" 1401

402

403

59

Page 66: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc e Building: _4_0_0 _________ L_a_b_IR_o_o_m_:_1_4_4_0_B_a_s_em_e_nt_S_t_o_ra~g~e-

Meter1 Meter2 Meter3 Meter4 Meter5

Date: 11/14/2014 Not In Service 11/14/2014 Not In Service Not In Service

Make: Ludlum Ludlum Model: 2221 2221

SN: 161591 89650 Probe Make: Ludlum Ludlum

Probe Model: 43-68 43-37 Probe SN: 118227 148928

Probe Area (cm'}: 126 584 Next Cal. Date: 11/7/2015 6/14/2015

Backqround Surface Material Metal Concrete Backqround(c) - Time(Min)): 2300 10 10950 10 uRem/hr

CS Isotope -ActiviMuCi: C-14 0.159 C-14 0.159

CS Sourcefcom 8426 4950 L,. L, (Counts} 35 74 77 157 NA NA

Direct MDC, Scan MDC

(dom/100cm2l 556 1733 298 1903 NA NA

MDCR , MDC Count Rate 392 288 1449 1122 NA NA Total Efficiency, Isotope: 10.5% C-14 9.0% C-14

Source Efficiency 0.25 0.25 NA Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*t:1*A*C

MDCR

s,. (60/i}

B = Background Counts

T = Counting Time In Minutes "'=Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm2

C =Other Constants and Factors When Needed Ehr= Human Factor Efficiency

"' = Source Efficiency s, = 1.38"SQRT(B,}

i = Counting Interval

60

Page 67: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/14/14 ~-----------

Surveyor: Korreesa Williams

Area Surve Results

Wipe Number

Rev 1-30-2015

Description

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete

Tile Over Concrete Tile Over Concrete

Tile Over Concrete

Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal Metal

Metal JDoor Metal

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 t--~~QQ_ <200 <200 j <200 <200 <200 <200 <200 <200 <200 <200 <200

--<200· <200~ <200 <200 <200 <200

'"-""""~"""~""""

<200 <200 <200 ······<200· <200 <200

<200 <200 <200 <200 <200 <200

... <260 <200 <200 fflµµµn--•-'~"~

<200 <200 I <200 ····<200·· <266 <200

<200 <200 <200 --··:.:206- <200 <200

<200 <200 <200 <200 <200 <200 <200 <200 <200 <2ci-o·· <200 <200 <200 ··.;:255-·

I <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 <200 ·+ <200 <200 <200

l. <200 <200

Building: _4..;..00.;....__Room: 1440 Basement Storage

Finish Date: _1_1'-/1_4.;.../1_4 ___ _

Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross P Average dpm/100

(cpm) cm2 (C14)

61

Page 68: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/14/14 ~~~~--------

Surveyor: Korreesa Williams

Area Surve Results Wi e Tests

J3 J3 Wipe

Description (dpm/100 (dpm/100

Number cm2) cm2

)

H-3 C-14

Metal

Rev 1-30-2015

J3 (dpm/100

cm2)

High E

<200

Building: _4_0_0 __ Room: 1440 Basement Storage

Finish Date: 11/14/14 -------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Gross Gross J3 Survey Gross dpm/100 Survey High Average dpm/100

Meter# (cpm) cm2 Meter# (cpm) (cpm) cm2 (C14)

(C14)

62

Page 69: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

METAL STORAGE CABINET

466 469

465 468

464 467

455 453 454

ROOM 1440

15.5"

.i::. .i::. .i::. " 0 " " .... N

II' :::c: m 451 452 .... "T1

446 450

447 449 14.5" ___ _ 448

4~:t 460 457

4623 459 456

"'1;;1 458

Rev 1-30-2015 63

Page 70: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc te Building: ..;4:.=0.:.0 ___ ..;Vc.::a;;cri.:.o.:.us::...::L.:.oc:.:a:.:ti:.=o:..:ns;;_;_P.:.o.:.st'"'P-'h-"a:.:s.:.e...;1;..D.:.e.:.c:.:o"-n'------

Meter 1 Meter2 Meter3 Meter4 Meter5

Date: 11/14/2014 Not In Service 11/14/2014 Not In Service Not In Service

Make: Ludlum Ludlum

Model: 2221 2221

SN: 161591 89650

Probe Make: Ludlum Ludlum

Probe Model: 43-68 43-37

Probe SN: 118227 148928

Probe Area (cm'): 126 584

Next Cal. Date: 11/7/2015 611412015

Backoround Surface Material Laminate Concrete

Background(c} - Time(Min\l: 1535 10 5964 10 uRem/hr

CS Isotope -ActiviMuCi): C-14 0.159 C-14 0.159

CS Source(cpm 8426 4950 L,. Ld (Counts) 29 61 57 117 NA NA

Direct MDC, Scan MDC

( dom/100cm2} 458 1416 222 1405 NA NA

MDCR , MDC Count Rate 286 202 857 616 NA NA

Total Efficiencv, Isotope: 10.5% C-14 9.0% C-14

Source Efficiencv 0.25 0.25 NA

Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration

MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*£1*A*C

MDCR

s,. (60/i}

B = Background Counts

T = Counting Time In Minutes "'=Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm'

C =Other Constants and Factors When Needed Ehl= Human Factor Efficiency £, = Source Efficiency s, = 1.38.SQRT(B,)

i = Counting Interval

64

Page 71: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11 /14/14 ~~~~~~~~~~~~~~~~~~~

Surve or: Korressa Williams

Wipe Number

476

Area Surve Results

Description

Floor Location 257-Post Decon Tile Over Concrete

'Floor Location 258-Post Decon Tile Over Concrete

Floor Location 263-Post Decon Tile Over Concrete

Floor Location 393- Post Decon Tile Over Concrete

Floor Location 394- Post Decon Tile Over Concrete

Shelf Location 181-Post Decon Laminate

I Shelf Location 211- Post Decon Laminate

Rev 1-30-2015

Wipe Tests

~ ~ ~ (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200

Building: _4_00 __

Various Location Post Phase 1 Decon

Finish Date: 11/14/14 Surve or: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

3

Gross High

(cpm)

1600 "-"~"-"-'"-·'" "'' "

1300 3000

"""--··~·

2850 "~1400~

423 4

Gross Average

(cpm)

1300

~·~~-u-uw~

~ dpm/100

cm2 (C14)

1339 958

3527 ···---·-·······-····

3241 ·- -···-~-·-·~·~··

863 1561

·-·---~-·--··-··-· ,_ 1107

65

Page 72: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Survey Meter Information

Site: Inc e Various Locations Post Decon Phase 2 Buildino: 400

Meter 1 Meter2 Meter3 Meter4 Meter5 Date: 11/25/2014 Not In Service 11/25/2014 Not In Service Not In Service

Make: Ludlum Ludlum Model: 2221 2221

SN: 161591 89650 Probe Make: Ludlum Ludlum Probe Model: 43-68 43-37

Probe SN: 118227 148928 Probe Area (cm'): 126 584

Next Cal. Date: 11/7/2015 6/14/2015 Backoround Surface Material Tile over Concrete Tile over Concrete Backgroundlcl - TimelMinll: 1419 10 6501 10 µRem/hr

CS Isotope - ActivitvCllCi\: C-14 0.159 C-14 0.159 CS Sourcelcom\ 8636 6199

L,. L, (Counts) 28 58 59 122 NA NA Direct MDC, Scan MDC

(dpm/100cm2 441 1361 231 733 NA NA

MDCR , MDC Count Rate 269 188 923 671 NA NA Total Efficiencv, lsotooe: 10.5% C-14 9.0% C-14

Source Efficiency 0.25 0.25 NA Please See MARSSIM Chapter 6 for a more detailed explanation of equations.

Le= Critical Detection Level Ld= a priori Detection limit

MDC= Minimum Detectable Concentration MDCR= Minimum Detectable Count Rate

Rev 1-30-2015

Direct MDC=

Scan MDC=

MDCR=

3+4.65*SQRT(B) T*E1*A*C

MDCR

s,. (60/i)

B = Background Counts T = Counting Time In Minutes c1 =Total Detector Efficiency in Counts/Disintegration

A = Physical Probe Area in cm2

C = Other Constants and Factors When Needed Ehr= Human Factor Efficiency e, = Source Efficiency s, = 1.38"SQRT(B,)

i = Counting Interval

66

Page 73: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: Inc te

Start Date: 11/25/14 -------------------Surveyor: Korreesa Williams

Wipe Number

Area Surve Results

Description

Lab 3414 Location 263/478Tile Over Concrete

Lab 3414 Location 257/476Laminate Lab 3414 Location 258/477Tile Over Concrete

Freezer Corridor Location 393/479Tile Over Concrete

'Freezer Corridor Location 394/480Tile Over Concrete

3419 Location 181/481Tile Concrete

Rev 1-30-2015

Wi e Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 <200 <200 <200 <200 <200

Various Locations Post Decon

Finish Date: 11/25/14 --------Surveyor: Matthew Mueller

Direct Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

1 3

Scan Measuremer

Gross High (cpm)

1315 1502 1716 1500 1300 300

Gross Average

(cpm)

67

Page 74: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11/25/14 ------------------~

Surveyor: Korreesa Williams

Wipe Number

Area Surve Results

Description

Lab 3414 Location 263/478Tile Over Concrete

Lab 3414 Location 257/476Laminate Lab 3414 Location 258/477Tile Over Concrete

I Freezer Corridor Location 393/479Tile Over Concrete

I Freezer Corridor Location 394/480Tile Over Concrete

181/481Tile Over

Rev 1-30-2015

Wipe Tests

p p p (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 -<200"" ··~ <200 <200 --··~~vmu ~''~-"·--·-"'"""'-"

<2Q.O I· <200 <200 <200 <200 <200

<20Q l <200 <200 <200 <200 <200 ------L

Various Locations Post Decon

Finish Date: 11/25/14 --------Surveyor: Matthew Mueller

Direct Measurements Scan Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

Gross High

(cpm)

Gross Average

(cpm)

68

p dpm/100

cm 2 (C14)

762 12972

«mUU""~'-MU-v

15995

Page 75: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Site: lncyte

Start Date: 11 /25/14 ~~~~~~~~~~~~~~~~~

Surveyor: Korressa Williams

Wipe Number

31 36

Area Surve Results

Description

Lab 3414 Location 263/478 Tile Over Concrete

Lab 3414 Location 257/476 Laminate

Lab 3414 Location 258/477 Tile Over Concrete

Freezer Corridor Location 3931479 Tile Over Concrete

Rev 1-30-2015

Wi e Tests

13 13 13 (dpm/100 (dpm/100 (dpm/100

cm2) cm2

) cm2)

H-3 C-14 High E

<200 <200 <200 <200 <200 <200 <200 <200 <200

'""'""''"""•····-··'"'

<200 <200 ··~-·~~··~-·-··

Various Locations Post Decon & Tile Removal

Finish Date: 11/25/14 ~~~~~~~~

Surveyor: Matthew Mueller

Direct Measurements

Survey Gross dpm/100 Survey Meter# (cpm) cm2 Meter#

(C14)

1 216 560 3

Scan Measurements

Gross High (cpm)

900

Gross Average

(cpm)

825

13 dpm/100

cm2 (C14)

333

69

Page 76: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

WIPE TEST LSC RESULTS

Rev 1-30-2015 70

Page 77: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

:1,l/l,9/14 5 :07: l!LP?-1 Protocol# 2 - Triple Lable DPM.lsa

-·--·-··-·········· Page fLl User: Default

Assay Definition- LSC Results Assay Description: INCY'JiE CORPORATION

Assay Type: DPM (Triple) Report Name: Report1 Output Data Path: C:\Packard\Tricarb\Results\Default\Triple Lable DPM Raw Results Path: C:\Packard\Tricarb\Results\Default\Triple Lable DPM\20141118 0854.results Comma-Delimited File Name: C:\Packard\Tricarb\Results\Default\Triple Lable DPM\1410.csv Assay File Name: C:\Packard\TriCarb\Assays\Triple Lable DPM.lsa

Count Conditions-

Nuclide: Triple Label Quench Indicator: tSIE/AEC External Std Terminator (sec): 0.5 2s% Pre-Count Delay (min): 0.00

Quench Sets: Low Energy: 3H-UG-08252014 Mid Energy: 14C-UG-020614 High Energy: 32P-UG-02-28-05

Count Time {min}: 2.00 Count Mode: Normal Assay Count Cycles: 1 #Vials/Sample: 1

Repeat Sample Count: 1 Calculate % Reference: Off

Background Subtract: On - 1st Vial Low CPM Threshold: Off 2 Sigma % Terminator: On - Any Region

Regions A B c

LL 0.0

12.0 156.0

Count Corrections-

UL 12.0

156.0 2000.0

Static Controller: On Colored Samples: On Coincidence Time (nsec) : 18

Half Life-

Half Life Correction: Off

Bkg Subtract 1st Vial 1st Vial 1st Vial

2Sigma % Terminator 0.00 0.00 0.00

Luminescence Correction: On Heterogeneity Monitor: n/a Delay Before Burst (nsec} : 75

Regions Half Life Units Reference Date Reference Time A B c

S# 1 = Background

Cycle 1 Results S# Time CPMA CPMB CPMC DPMl DPM2 DPM3 tSIE LUM

1 10.00 4 12 6 0 0 0 575 1 2 2.00 0 -3 -2 2 -3 -2 573 0 3 2.00 -0 -1 -1 -0 -1 -1 612 0 4 2.00 -1 -3 1 -1 -4 1 578 4 5 2.00 1 -0 -1 3 -0 -1 610 0 6 2.00 1 -1 -4 2 -0 -4 623 0 7 2.00 -0 -4 -2 1 -5 -3 548 0

Rev 1-30-2015

Rm 238- (2-36)

71

Page 78: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Protoeol# 2 - Triple Lable DPM.lsa

8 2.00 9 2.00

10 2.00 11 2. 00 12 2.00 13 2.00 14 2. 00 15 2.00 16 2.00 17 2.00 18 2.00 19 2.00 20 2.00 21 2.00 22 2.00 23 2.00 24 2.00 25 2.00 26 2.00 27 2.00 28 2.00 29 2.00 30 2.00 31 2.00 32 2.00 33 2.00 34 2.00 35 2.00 36 2.00 37 2.00 38 2.00 39 2.00 40 2.00 41 2.00 42 2.00 43 2.00 44 2.00 45 2.00 46 2.00 47 2.00 48 2.00 49 2.00 50 2.00 51 2.00 52 2.00 53 2.00 54 2.00 55 2.00 56 2.00 57 2.00 58 2.00 59 2.00 60 2.00 61 2.00 62 2.00 63 2.00 64 2.00 65 2.00 66 2.00 67 2.00 68 2.00 69 2.00

Rev 1-30-2015

1 -0

4 -2

1 -1

2 1

-2 2 1 3 0 2 1

-1 -0 -1 -1 -1 -1 -1

1 1 4 0 2 0 0 1 2 1 0

-1 -0

1 0 1

-2 0

-1 4 1

-1 -2 -1

3 0 2 0 2 1 2

-3 -2 -2 -1

2 2 4 0 3

-5 0 1

-5 -3 -1 -7 -2 -6 -1 -2

1 -3 -3 -1 -3 -3 -2 -2 -3 -4 -4 -3 -3 -7 -2 -3 -4 -5 -3 -7 -5 -6 -5

1 -5 -4 -4 -1 -5 -5 -1 -5 -1 -4

1 -6 -2 -3 -4 -2 -3 -2 -2 -6 -4 -4 -5 -6 -4 -6 -6

-1 -1

0 1

-3 -3 -1 -0 -0 -3 -2 -0

3 -2

0 -0 -2 -1

0 -2

1 2

-2 0

-0 -0

0 2

-1 -4 -1 -2 -0 -2

1 0 2 1

-0 1

-2 -3

1 -2 -2 -2 -2 -1

1 -1 -4

0 2

-1 -2 -3 -1 -1

0 0

-3 -3

4 -0

8 -2

3 -2

6 4

-2 6 2 6 2 6 3

-2 -0 -1 -2 -2 -0 -1

3 2

12 1 6 2 2 4 7 4 3 0

-1 3 2 3

-5 2

-1 10

4 -1 -2 -3

9 1 5 2 5 5 5

-5 -3 -2 -1

7 6

10 3 9

-6 1 1

-5 -3

0 -8 -3 -6 -1 -2

1 -4 -4 -2 -3 -3 -2 -3 -3 -5 -4 -3 -4 -9 -3 -4 -5 -5 -2 -8 -5 -7 -6

1 -6 -5 -5 -0 -6 -5 -1 -6 -0 -4

2 -7 -3 -4 -5 -2 -4 -3 -2 -6 -4 -5 -6 -8 -5 -7 -7

-1 639 -1 622

0 648 1 618

-3 590 -3 622 -1 644 -0 645 -0 655 -3 636 -3 587 -0 603

4 598 -2 605

0 609 -0 508 -3 423 -1 593

0 579 -2 549

1 616 -3 599 -2 619

0 616 -0 650 -0 654

0 662 3 661

-1 654 -4 633 -1 653 -2 600 -0 629 -2 621

1 581 0 598 2 614 1 620

-0 553 2 645

-3 656 -4 658

2 669 -3 659 -3 660 -2 660 -2 669 -1 667

1 657 -1 655 -4 613

0 469 2 693

-1 609 -2 385 -3 614 -1 666 -1 668

0 662 0 659

-3 646 -4 630

0 3 2 5 0 7 0 3 0 0 0 0 4 3 3 4 4 4 4 0 4 4 0 4 0 0 3 0 4 3 4 4 5 0 3 4 0 0 4 0 0 3 0 3 0 3 4 4 3 4 3 3 0 4 6 0 9 4 0 3 5 7

J?~rui ... L~ User: Default

Rm 266-(37-71

72

Page 79: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Protocol# 2 - Triple Lable DPM.lsa

70 2.00 1 71 2.00 4 ·---72 2.00 -1 73 2.00 0 74 2.00 1 75 2.00 -2 76 2.00 -1 77 2.00 0 78 2.00 -2 79 2.00 80 2.00 81 2.00 82 2.00 83 2.00 84 2.00 85 2.00 86 2.00 87 2.00 88 2.00 89 2.00 90 2.00 91 2.00 92 2.00 93 2.00 94 2.00 95 2.00 96 2.00 97 2.00 98 2.00 99 2.00

100 2.00 101 2.00 102 2.00 103 2.00 104 2.00 105 2.00 106 2.00 107 2.00 108 2.00 109 2.00 110 2.00 111 2.00 112 2.00 113 2.00 114 2. 00 115 2. 00 116 2.00 117 2. 00 118 2. 00 119 2.00 120 2.00 121 2.00 122 2.00 123 2.00 124 2.00 125 2.00 126 2.00 127 2.00 128 2.00 129 2.00 130 2. 00 131 2.00

Rev 1-30-2015

1 -1 -0 -1

0 1

-1 -2

0 2

-1 2

-0 7

-2 1

-1 3 1 1 1 1 1

-2 2

-2 -1 -1

2 3 1

-0 -1 -0 -1

1 2 1

-0 -1

3 -0

2 -0

2 -2

0 -2

3 -1

0 -1 -1

-3 -2 -5 -1 -2 -3 -4 -4 -2 -2 -5 -4 -4 -5 -4

2 -0 -5 -4 -5 -5

0 -2 -3 -4 -4 -4 -3 -3 -4 -1 -4 -0 -2 -5 -4 -5

3 -1 -7 -3

0 -2 -0 -2 -3 -5 -3 -2 -1 -5 -1

1 -1 -5 -5 -0 -2 -6 -2 -3 -2

1 -3

0 -2

1 1 2

-1 -0 -2 -2 -1 -0

1 -0 -0

1 0 1

-3 0

-1 -0 -1 -3 -2

1 1 2

-4 -0 -1 -3 -4

0 2 0

-2 1

-1 -0 -0 -3 -1 -2

0 -2 -1 -2 -0 -1

0 -2 -5 -4

0 -0 -0

0 -2 -2 -0

3 9 0 1 4

-3 -1

2 -3

4 -2

1 -0

2 4

-3 -4

2 6

-1 7

-0 16 -4

4 -0

7 3 4 4 3 5

-5 4

-2 -0 -0

3 7 5 1

-2 0

-2 3 5 3 1

-3 8 1 5

-1 6

-2 2

-5 7

-1 2

-2 -2

-4 -2 -6 -0 -3 -3 -5 -4 -2 -2 -6 -4 -5 -6 -5

3 -0 -6 -5 -5 -6

1 -3 -3 -4 -4 -5 -3 -4 -4 -1 -4

1 -1 -5 -5 -6

4 -2 -8 -4

1 -2

0 -2 -4 -5 -3 -2 -1 -5 -2

1 -1 -5 -6

0 -3 -7 -2 -3 -2

2 631 0 -3 642 3

0 479 5 -2 497 0

2 560 0 2 463 4 2 500 5

-1 612 0 -0 582 4 -3 628 3 -2 563 5 -1 628 4 -0 637 4

1 604 0 -0 378 4 -0 347 3

2 539 3 0 582 0 1 576 0

-3 584 5 0 639 4

-1 573 3 -0 616 2 -1 582 4 -3 576 4 -3 599 4

2 629 3 2 584 0 3 589 3

-4 503 8 -0 495 3 -1 490 4 -3 523 7 -4 550 6

0 598 5 2 620 8 0 524 5

-3 532 2 1 575 6

-1 611 9 -0 550 4 -0 536 6 -4 518 7 -1 537 3 -2 588 6

0 525 7 -3 575 8 -1 508 I -2 468 8 -0 553 5 -1 505 4

0 603 8 -3 514 3 -6 572 6 -5 560 11

0 558 8 -0 490 7 -0 605 3

0 487 5 -2 490 7 -2 524 8 -0 492 10

Page# 3 User: Default

Rm 268- (72-96)

Rm282-(97-116)

Deck Area of bldg. 336 (117-131)

73

Page 80: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

Protocol# 2 - Triple Lable DPM.lsa

132 2.00 133 2.00 134 2.00 135 2. 00 136 2.00 137 2.00 138 2.00 139 2.00 140 2.00 141 2.00 142 2.00 143 2.00 144 2.00 145 2.00 146 2.00 147 2.00 148 2.00 149 2.00 150 2.00 151 2.00 152 2.00 153 2.00 154 2.00 155 2.00 156 2.00 157 2.00 158 2.00 159 2.00 160 2.00 161 2.00 162 2.00 163 2.00

3 2

-1 12 -1

1 2 3 1 2 3 0

-1 1 1 2 2 3 1

-1 -0

4 0 2

-2 0 1

-1 -1 -1

2 -0

164 2.00 0 165 2.00 3 166 2.00 1 167 2.00 5 168 2.00 -2 169 2.00 3 170 2.00 -0 171 2.00 0 ---172 2.00 2 173 2.00 2 174 2.00 -1 175 2.00 -0 176 2.00 0 177 2.00 178 2.00 179 2.00 180 2.00 181 2.00 182 2.00 183 2.00 184 2.00 185 2.00 186 2.00 187 2.00 188 2.00 189 2.00 190 2.00 191 2.00 192 2.00 193 2.00

Rev 1-30-2015

2 2

-0 0 3

18 3 1

-2 3 3 1

-2 -2 -1 -0

2

-4 -2 -3

9 -5 -5 -7 -5 -5 -6 -2 -8 -2 -4 -4 -5 -4 -2 -6 -0 -6 -2

1 -1 -7

2

-2 -1 -2 -3 -2 -2 -4 -3 -1 -3 -4

3 -2

2 -0 -2

2 -2 -4

0 1

-1 1

10 5

-1 27 -0

3 6 9 3 7 7 4

-2 3 4 7 6 8 4

-2 2

11 0

-5 -2 510 -3 -1 617 -3 -2 594 10 -4 521 -5 -3 531 -6 -3 566 -7 -5 547 -7 -3 530

6 6 8 3 9 9 9

10 -6 -1 563 8 -7 -3 540 8 -2 -4 599 6

-11 3 427 13 -2 -2 576 4 -6 2 565 8 -5 -0 557 7 -6 -3 583 10 -6 2 601 7 -2 -3 592 6 -6 -4 593 4 -0 0 405 3 -8 1 534 5 -2 -1 463 3

2 1 538 6 -0 5 -2 -0 545 6 -3 -6 -7 -3 277 7

0 -0 3 0 516 3 -2 -1 3 -2 -1 534 7

1 -3 -2 2 -3 516 6 -1 2 -2 -1 2 550 3 -7 -0 1 -8 -0 583 12 -6 1 6 -8 2 570 8 -1 -3 -0 -1 -3 525 3 -2 -0 1 -2 -0 549 3 -4 -0 8 -6 -0 604 7 -2 -2 3 -2 -3 566 3 -2 -0 12 -3 -0 664 0 -2 3 -3 -2 3 659 0 -2 -3 6 -2 -3 673 6 -3 -3 0 -3 -4 661 0 -3 -1 2 -3 -1 657 0

·~--_~5-----~2----5---_~5------2-~6-6-4-~0

-3 1 5 -4 1 659 0 -4 -4 -0 -4 -4 662 0 -5 -1 1 -5 -1 654 0 -6 -0 2 -7 -0 664 0 -4 -1 5 -5 -1 658 4 -5 -0 5 -6 -0 662 0 -6 -1 1 -7 -1 664 0 -6 -4 2 -7 -4 653 0 -3 -3 7 -3 -4 655 0 29 -0 30 32 -0 652 0 -4 0 7 -5 0 655 0 -4 -2 4 -4 -2 634 0 -3 -2 -3 -3 -3 653 0 -3 -2 8 -4 -3 674 0 -4 -3 7 -5 -4 655 0

0 -2 2 1 -3 460 0 -6 3 -2 -8 3 562 0 -4 0 -3 -5 0 451 5 -8 0 0 -10 0 465 0 -1 -3 -0 -0 -3 411 0 -8 -3 6 -9 -3 708 5

__ _ _ --~~g~ JL 4 User: Default

Rm 3407- (132-171)

Rm 3419 -(172-216)

74

Page 81: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

U_/l~l:!.! _$_;Q_7_;_~_1_j>}l_ _Q),l~~J:;a~ma_:r;~ JTM) - 1. ;u __ - ~erie1,Jtt ~~-i$_$J~

Protocol# 2 - Triple Lable DPM.lsa

194 2.00 195 2.00 196 2.00 197 2.00 198 2.00 199 2.00 200 2.00 201 2.00 202 2.00 203 2.00 204 2.00 205 2.00 206 2.00 207 2.00 208 2.00 209 2.00 210 2.00 211 2.00 212 2.00 213 2.00 214 2.00 215 2.00 216 2.00 217 2.00 218 2.00 219 2.00 220 2.00 221 2.00 222 2.00 223 2.00 224 2.00 225 2.00 226 2.00 227 2.00 228 2.00 229 2.00 230 2.00 231 2.00 232 2.00 233 2.00 234 2.00 235 2.00 236 2.00 237 2.00 238 2.00 239 2.00 240 2.00 241 2.00 242 2.00 243 2.00 244 2.00 245 2.00 246 2.00 247 2.00 248 2.00 249 2.00 250 2.00 251 2.00 252 2.00 253 2.00 254 2.00 255 2.00

Rev 1-30-2015

-1 0 2 1 2

-0 0 0

-0 -2 -1 -0

1 -1

1 -0

0 -0

3 3

-1 4 4

-1 -0 -2 -2

2 0

-0 0

-1 0

-1 1 1 2 1

-1 9 0 0 3 1

-1 2 1

-0 -0

2 1

-0 -1 -1

1 3

-2 3 2 3

-2 3

1 -4 -4

5 -4 -1 -0 -1 -2 -3 -0 -1 -2 -3 -5 -1 -6

4 13 13 -5 -0 -1 -2 -4

0 -2 -4 -3 -4 -4

3 -3 -4 -5 -4 -7 -1 -6 -3 -5 -4 -1 -3 -2 -1

0 -3 -5 -2 -2 -7 -5 -1 -4 -6 -3 -4 -3 -4 -1 -5

3 -0 -4

2 -1 -2 -0

1 -1 -2

0 -1

2 -0 -2 -3 -1 -1 -2 -3

0 -1 -2

-0 -1

1 -0 -1 -0 -2 -3

2 0

-1 -2 -2 -3 -1 -1 -2 -3

0 -2

0 -2 -1 -0 -1

2 -1 -0 -1

0 -2 -3 -1 -4

0 -3 -1 -1

-4 2 5 2 6

-1 1 1 0

-3 -2

0 4

-2 3 0 3

-2 4 3

-1 11

9

1 -5 -5

6 2 1 1

-2 2

-0 3 4 7 2

-1 21

2 2 7 3

-2 4 2 0 1 6 3 2 0

-3 4

10 -3

8 6 8

-4 9

1 -4 -4

6 -5 -1 -0 -2 -2 -3

0 -1 -3 -3 -5 -1 -7

5 16 15 -5 -1 -2

-4 1

-2 -5 -3 -4 -5

5 -4 -5 -6 -4 -8 -1 -7 -5 -5 -4 -2 -3 -2 -2

1 -3 -5 -4 -2 -8 -6 -1 -5 -8 -3 -4 -4 -4 -1 -6

3 356 0 -0 494 0 -5 571 0

2 495 0 -1 556 0 -2 377 0 -0 634 0

2 654 3 -1 615 4 -2 644 5

0 595 3 -1 584 7

3 568 3 -0 626 0 -2 582 4 -3 547 3 -1 567 5 -1 656 3 -2 587 0 -4 552 5

0 647 5 -1 533 5 -3 571 3

392 -4 -0 491 4 -1 372 3

1 421 0 -0 543 0 -1 563 4 -0 64 5 4 -2 603 4 -4 649 3

3 552 4 0 583 4

-1 635 4 -2 590 7 -2 558 4 -4 633 0 -1 588 0 -1 575 2 -2 586 4 -3 577 8

0 542 6 -2 584 7

0 574 7 -2 652 6 -1 581 6 -0 632 10 -1 576 9

3 625 6 -1 584 7 -0 570 11 -1 548 10

0 552 7 -2 566 4 -4 521 8 -1 530 4 -5 552 7

0 631 6 -4 581 6 -1 536 10 -1 617 3

--··--·P~.9!!_JL_~ User: Default

Rm 3212-(217-256)

75

Page 82: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

l:L /19 [H ___ 5 : Jl.'.Lt:?.4 .... PI•L. ___ -··· ___ . -· _Q_~~t ai?~a_:r;t . ..i..™L.::-_J, • 31, --.J?~.:r:-ial# ~.i!~~-8_ __ __ _ ____ .. . ____ gag~ iL2. Protocol# 2 - Triple Lable DPM.lsa User: Default

256 2.00 257 2.00 258 2.00 259 2.00 260 2.00 261 2.00 262 2.00 263 2.00 264 2.00 265 2.00 266 2.00 267 2.00 268 2.00 269 2.00 270 2.00 271 2. 00 272 2.00 273 2.00 274 2.00 275 2.00 276 2.00 277 2.00 278 2.00 279 2.00 280 2.00 281 2.00 282 2.00 283 2.00 284 2.00 285 2.00 286 2.00 287 2.00 288 2.00 289 2.00 290 2.00 291 2.00 292 2.00 293 2.00 294 2.00 295 2.00 296 2.00 297 2.00 298 2.00 299 2.00 300 2.00 301 2.00 302 2.00 303 2.00 304 2.00 305 2.00 306 2.00 307 2.00 308 2.00 309 2.00 310 2.00 311 2.00 312 2.00 313 2.00 314 2.00 315 2.00 316 2.00 317 2.00

Rev 1-30-2015

0 3

-1 0 3 3

-1 1 2 1 2

-0 -1 -1

1 -1 -1 -1

2 2

-1 -3

2 4 1 0

-0 0

-1 -1

0 3 2

-0 0 1 2 1 1 2

-0 -1

2 3 1 1

-1 -1

0 2 0 2 2 3

-0 1

-1 -1

1 -2

1 1

-5 -1 -3 -3 -2 -3 -3 -4 -3 -0

3 -2

1 1

-0 -4 -3 -5 -5 -4 -4 -4 -7 -4 -2

3 2

-3 -5 -6 -5 -4 -4 -2 -4 -2 -3

0 -2 -0 -5 -1 -0 -4 -1 -1 -2 -3 -3 -2 -2 -8 -4 -2 -5 -5 -6 -1 11 -1 -4 -4

1 -1

0 -3

2 3

-0 -2 -0 -2

1 2 1

-0 0

-2 -0 -1 -4 -1 -2 -3 -4 -2 -5 -2 -2 -2

1 -0 -1 -0 -0

0 -2 -4 -2 -2 -4 -1 -2 -2

3 -3 -4

0 1

-1 -1 -2

0 -1 -2

0 -1 -1 -2

0 1

-2 -3 -0

2 6

-1 1 8 7

-0 3 6 2 4 1

-2 -3

4 -2 -2 -0

7 6

-0 -7

6 9 2

-1 -1

2 0

-1 2 7 6 0 2 3 6 3 4 5 1

-2 4 8 3 3

-2 -1

2 6 1 6 6 7 1 3

-1 -3 -1 -5

3 7

-6 -1 -3 -3 -3 -5 -4 -5 -4

0 3

-3 2 2

-0 -5 -4 -5 -6 -5 -4 -3 -7 -5 -2

4 3

-3 -6 -7 -6 -5 -5 -2 -4 -1 -4

1 -2 -0 -6 -0 -1 -4 -1 -2 -3 -3 -3 -2 -2 -9 -5 -2 -5 -6 -6 -1 13 -1 -5 -5

2 605 4 -1 554 6

Rm 3214- (257-301) 0 649 11 -4 650 8

3 641 6 4 649 3

-0 637 4 -3 616 8 -0 554 0 -3 604 3

1 615 2 2 452 0 1 471 3

-0 336 0 0 472 3

-2 395 5 -0 393 4 -1 540 0 -4 633 0 -1 515 0 -2 625 0 -3 373 5 -4 628 4 -3 665 0 -6 652 3 -2 652 3 -3 654 3 -2 649 4

1 638 5 -0 611 0 -1 615 0 -0 659 0 -0 665 10

0 659 3 -2 664 4 -4 624 0 -3 610 3 -2 644 0 -4 633 3 -1 650 6 -3 632 5 -3 645 7

4 635 0 -3 655 3 -5 635 6

0 648 0 1 619 4

-1 626 4 -1 581 0

Rm. 3226 - ( 302-331)

-2 580 6 0 635 3

-1 649 10 -2 646 7

0 653 8 -1 629 12 -1 637 4 -3 456 11

0 416 7 2 436 0

-2 455 0 -3 414 8 -0 331 7

76

Page 83: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

ll/J, ~ Ll.L . ~;_Q_7 t~ :L~!!f_._ ·--- .... . _ __Q1:1.s..Ilt~ Sm.11_:i;:t __ l1'.M) __ :__]._.~;i,_-= ___ $ ~:i;:_:t~ll _.1.;!i5 ~IL Protocol# 2 - Triple Lable DPM.lsa

318 2.00 319 2.00 320 2.00 321 2.00 322 2.00 323 2.00 324 2.00 325 2.00 326 2.00 327 2.00 328 2.00 329 2.00 330 2.00 331 2.00 332 2.00 333 2.00 334 2.00 335 2.00 336 2.00 337 2.00 338 2.00 339 2.00 340 2.00 341 2.00 342 2.00 343 2.00 344 2.00 345 2.00 346 2.00 347 2.00

11 2

-1 2

-1 -0

5 1 2

-0 -0 -1 -0

4 1 0 1

-2 1

-3 -0 -0 -0

3 2 1 3

-3 2

-1 348 2.00 1 349 2.00 0 350 2.00 -2 351 2.00 -1 352 2.00 2 353 2.00 1 354 2.00 1 355 2.00 0 356 2.00 1 357 2.00 2 358 2.00 1 359 2.00 -0 360 2.00 -1 361 2. 00 .. ___ 1 362 2.00 -0 363 2.00 1 364 2.00 0 365 2.00 3 366 2.00 -0 367 2.00 0 368 2.00 -3 369 2.00 3 370 2.00 -1 371 2.00 -1 372 2.00 373 2.00 374 2.00 375 2.00 376 2.00 377 2.00 378 2.00 379 2.00

Rev 1-30-2015

2 -1

1 0 0 0

-2 2

-5 -4

1 -1 -2 -2 -3 -3 -3 -7 -0 -3 -2 -1 -5 -4 -5 -4 -0 -1 -4 -3 -2 -3 -0 -3 -2 -1 -6

3 -7 -5 -3

0 -2 -3 -4 -3 -2 -6 -5 -0 -5 -3 -3 -7 -3 -6 -5 -3 -2 -1 -2

0 -3 -3

1 -4 -2 -3 -5 -8

-1 -2

1 -1 -4 -3 -3 -1

1 3

-0 -2

1 -2 -2 -2 -2 -1 -1 -3

0 -0

1 1

-1 1

-0 0 0

-2 -4 -1

1 -2

0 -4 -1 -3

1 -0 -1 -2

1 -0 -3 -2 -3

0 -3 -3 -3 -1

2 -0 -2 -1 -1

0 1 1

-1 -2

30 7

-3 6

-2 0

13 3 6 2

-0 -0

0 9 4 2 3

-2 3

-7 1 1

-0 8 5 3 6

-8 5

-3 5 2

-3 -1

6 2 4 2 2 6 4

-1 -1

4 0 5 2 8 1 2

-5 7

-1 -3

6 -1

2 2 1 2

-4 7

-7 -5

2 -1 -1 -2 -4 -4 -4 -9 -0 -3 -3 -2 -5 -4 -5 -4 -0 -0 -5 -4 -2 -4 -1 -4 -3 -1 -8

4 -8 -6 -4

1 -2 -3 -5 -2 -3 -7 -6 -0 -5 -4 -3 -9 -3 -8 -5 -3 -1 -1 -2

1 -3 -3

1 -4 -2 -4 -5

-10

-1 519 -2 564

1 452 -1 623 -4 544 -4 622 -4 576 -1 570

1 643 3 615

-0 577 -3 630

1 654 -2 651 -2 668 -3 658 -3 659 -1 668 -1 654 -4 443

0 447 -0 645

2 659 2 656

-1 652 1 664

-0 659 0 394 0 649

-3 660 -5 661 -1 664

2 663 -3 661

0 649 -4 667 -1 668 -4 663

1 663 -0 669 -1 664 -2 662

1 663 -0 665 -3 619 -2 625 -3 625

0 608 -4 614 -3 626 -3 591 -1 613

3 629 -0 593 -3 641 -1 606 -1 636

0 552 1 600 1 616

-1 643 -2 657

2 16

0 0 0 4 3 0 3 6 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 4 0 8 4 0 5 0 4 5 4 4 0 4 0 0 4 0 3 4 0 4 3 4 6 5

·----_!1~~-l .1 User: Default

Rm. 3403- (332-361)

Rm 3474- (362-381)

77

Page 84: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

:aLl9/J,i ,S:Q7: 24 P~L ___ .. __ J~.~DJ;.A.~l;!ua;:.t __ (TI-!L..: __ _L 3J ::--~-~glJ!: ~21,52.~ Protocol# 2 - Triple Lable DPM.lsa

380 2.00 381 2.00 382 2.00 383 2.00 384 2.00 385 2.00 386 2.00 387 2.00 388 2.00 389 2.00 390 2.00 391 2.00 392 2.00 393 2.00 394 2.00 395 2.00 396 2.00 397 2.00 398 2.00 399 2.00 400 2.00 401 2.00 402 2.00 403 2.00 404 2.00 405 2.00 406 2.00 407 2.00 408 2.00 409 2.00 410 2.00 411 2.00 412 2.00 413 2.00 414 2.00 415 2.00 416 2.00 417 2.00 418 2.00 419 2.00 420 2.00 421 2.00 422 2.00 423 2.00 424 2.00 425 2.00 426 2.00 427 2.00 428 2.00 429 2.00 430 2.00 431 2.00 432 2.00 433 2.00 434 2.00 435 2.00 436 2.00 437 2.00 438 439 440 441

2.00 2.00 2.00 2.00

Rev 1-30-2015

2 -1

1 1 4 1

-1 5 1

-1 2

-0 1 2 1 4

-0 1 1 2

-0 2

-0 1 4

24 1

-2 2

-0 2 2

-1 -2

0 2

-1 31 -1 -2

0 1

-1 2

-0 1

-1 1

-0 -1 -0

3 1 1 2

16 3

-2 1 0 2 1

0 -5 -8 -2 -5

2 -6 -2 -4 -7 -1 -4 -4 -4

7 14 -6 -4 -4 -4 -3 -3 -2 -6 -2 -4 -5 -6 -6 -5

1 -3 -6 -5 -3 -1 -5

1 -5 -4 -5 -5 -5 -6 -4 -5 -5 -2 -4 -7 -0 -3 -3 -5 -5 -5 -1 -2 -5 -3 -3

0

-1 0

-4 -0 -1 -1 -0 -3 -1

0 1

-3 0

-1 -2

1 0

-1 1

-1 -4 -4 -4 -1

2 4

-1 -3 -2 -1 -3 -0 -3 -1

0 4

-1 0

-4 0 0

-1 -1 -1 -0 -2

2 -0 -4

2 -2 -0

1 -3

1 2

-2 -3

2 -0 -1 -3

3 0 6 3

10 2

-1 11

4 0 6 1 4 7

-0 6 2 3 5 5 0 8 1 4 9

57 4

-2 6 1 4 6

-0 -3

1 7

-2 87 -0 -4

2 5 0 7 1 4

-1 3 1 1

-0 7 3 5 7

35 7

-3 4 2 6 3

0 -6 -9 -3 -7

3 -6 -2 -5 -8 -2 -4 -6 -5

9 17 -8 -5 -5 -5 -2 -3 -2 -8 -3 -9 -6 -6 -7 -5

2 -4 -7 -6 -4 -3 -5 -5 -5 -4 -6 -6 -6 -7 -4 -6 -6 -3 -4 -8

0 -4 -4 -6 -7 -9 -2 -2 -6 -4 -3

1

-1 640 0 638

-4 456 -0 540 -1 620 -1 575 -0 607 -4 614 -1 572

0 478 2 564

-3 518 0 499

-1 513 -3 440

2 459 0 498

-1 551 1 591

-1 545 -4 537 -4 407 -4 595 -1 573

3 606 5 582

-1 606 -3 545 -2 555 -1 592 -4 583 -0 630 -3 298 -1 357

0 374 5 386

-1 420 0 448

-4 641 0 436 0 568

-1 547 -1 572 -1 619 -0 633 -2 555

2 605 -0 573 -5 612

3 608 -3 580 -0 622

2 574 -3 613

2 660 3 658

-3 625 -3 577

2 -0 -1 -3

618 634 595 576

0 0 0 0 0 3 0 3 0 6 3 4 0 4 0 0 0 0 4 0 0 3 0 5 0 0 4 6 4 0 0 0 0 0 4 0 0 1 0 5 0 0 0 4 4 0 5 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

_.f§,g~ i ... ~. User: Default

Lab Corridor bldg 400 (382-401)

Rm 3238- ( 402-446)

78

Page 85: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

:l,.lLl,!) /H____ 5.;97 :_~LPM.. .. ·-····-··-· [email protected];a~mar.L l'-rM} __ '.".....1.~-~l '.". .. ~~~i.~JJL..!.~~-5_!UL ... Protocol# 2 - Triple Lable DPM.lsa

442 2.00 443 2.00 444 2.00 445 2.00 446 2.00 447 2.00 448 2.00 449 2.00 450 2.00 451 2.00 452 2.00 453 2.00 454 2.00 455 2.00 456 2.00 457 2.00 458 2.00 459 2.00 460 2.00 461 2.00 462 2.00 463 2.00 464 2.00 465 2.00 466 2.00 467 2.00 468 2.00 469 2.00 470 2.00 471 2.00 472 2.00 473 2.00 474 2.00 475 2.00 476 2.00 477 2.00 478 2.00 479 2.00 480 2.00 481 2.00 482 2.00 483 2.00 484 2.00 485 2.00

1 1 2 0 2 0 1 2

-1 1 0 1

-3 -1 -0

0 1 2

-2 2 3 3 0 0 1 1 1 4

-2 3 2 4 3 0 2

-1 7 3 1 2 3 6 4 0

Missing vial 486. 487 2.00 129164 488 2.00 14040 489 490

2.00 2.00

Rev 1-30-2015

1281 49

-3 -3 -3 -2 -0 -2 -5 -3 -3 -4 -0 -2 -3 -1 -7 -4

2 -0

7 -3 -2

2 -2 -1

0 -3

1 0

-4 1

-7 3

-1 -6 -1

1 -0

3 -3 -3

2 2

-2 -3

1 4

-1 -1

4 -1

1 -2 -1 -1 -2 -0 -1 -4

1 -0

2 -3 -2 -1 -0 -2 -1 -1 -4

0 1

-3 1

-1 0

-2 -1

4 -1 -4 -0

2 -2 -3 -3 -3 -1

2

4 4 6 1 4 1 3 6

-1 3 0 4

-5 -1

2 2 2 5

-7 6 7 5 1 1 1 3 3 8

-2 5 7 7 6 3 5

-2 16

6 3 6 5

12 10

2

12815 6 211288 101010 656 962

22370 72355 -1699 118 101768 3126

-4 -5 -4 -3 -1 -2 -6 -4 -3 -4

0 -3 -3

0 -9 -4

2 0 9

-4 -2

2 -2 -1

1 -3

1 0

-5 1

-8 4

-1 -8 -1

2 -1

3 -3 -4

3 2

-2 -4

1 634 5 582

-1 613 -1 605

5 648 -1 610

2 608 -2 638 -1 655 -1 599 -3 617 -0 625 -1 629 -4 650

1 637 -0 639

2 487 -3 656 -3 651 -1 643 -0 650 -3 653 -1 654 -1 629 -5 627

0 623 1 643

-3 654 1 647

-1 650 1 653

-2 644 -1 640

5 649 -1 642 -4 661 -0 657

3 653 -2 666 -3 664 -3 660 -3 659 -1 663

2 653

-2097 23 981 980 509 526

119489 -312 10445 86087

-23085 121233

0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 3 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0

0 0 0 3

___ j>~g~jt _!)

User: Default

Rm 1440- (447-476)

Post Decon in Bldg. 400 (477-484)

79

Page 86: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

:1,J[~5LH __ ~:_Q5_;_§Q~M_ _____ _Qy~.n.t~SIDa.rt_ {~_L- :i,.:31 - SE!ri~l# 424558 -------~~g~ JL! ~rotocol# 1 - Triple Lable DPM.lsa User: RSO INC

Assay Definition-

Assay Description: INCYTE

Secondary Decontamination LSC Results

Assay Type: DPM (Triple) Report Name: Report1 Output Data Path: C:\Packard\Tricarb\Results\RSO INC\Triple Lable DPM Raw Results Path: C:\Packard\Tricarb\Results\RSO INC\Triple Lable DPM\20141125 1712.results Comma-Delimited File Name: C:\Packard\Tricarb\Results\RSO INC\Triple Lable DPM\1410.csv Assay File Name: C:\Packard\TriCarb\Assays\Triple Lable DPM.lsa

count conditions-

Nuclide: Triple Label Quench Indicator: tSIE/AEC External Std Terminator (sec): 0.5 2s% Pre-Count Delay (min): 0.00

Quench Sets: Low Energy: 3H-UG-08252014 Mid Energy: 14C-UG-020614 High Energy: 32P-UG-02-28-05

Count Time (min): 2.00 Count Mode: Normal Assay Count Cycles: l Repeat Sample Count: 1 #Vials/Sample: l Calculate % Reference: Off

Background Subtract: On - 1st Vial Low CPM Threshold: Off 2 Sigma % Terminator: On - Any Region

Regions A B c

LL 0.0

12.0 156.0

Count Corrections-

UL 12.0

156.0 2000.0

Static Controller: On Colored Samples: On Coincidence Time (nsec) : 18

Half Life-

Half Life Correction: Off

Bkg Subtract 1st Vial 1st Vial 1st Vial

2Sigma % Terminator 0.00 0.00 0.00

Luminescence Correction: On Heterogeneity Monitor: n/a Delay Before Burst (nsec) : 75

Regions Half Life Units Reference Date Reference Time A B c

S# 1 = Background

Cycle 1 Results S# Time CPMA CPMB CPMC DPMl DPM2 DPM3 tSIE LUM

1 10.00 5 7 6 0 0 0 566 2 2 2.00 4 14 -1 4 16 -2 610 0 3 2.00 3 12 -3 3 15 -4 560 0 4 2.00 0 2 -1 l 2 -1 610 0 5 2.00 3 2 -2 5 3 -2 642 0 6 2.00 2 -1 1 6 -2 1 597 0 7 2.00 2 -1 -1 6 -1 -1 639 0

Rev 1-30-2015

Room 3414 Floor Tile #263/478 (S# 2-6)

80

Page 87: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

UL~_s LH ___ Jt; Q§_;__OQ .!>!'L _____ __ <2_1.l_a.nti:'l.~mar_t:_tOO - _ l_._~;i, _ _:: __ se~~~U _424!:?~~L. _____ i>_c;i,~_.JL2 User: RSO INC Protocol# 1 - Triple Lable DPM.lsa

8 2.00 9 2.00

10 2.00 11 2. 00

0 2 1 4 1 0

-4 3

-0 0 1 8 2

-2 2

-0 1 3 3 6 2

1 -0

0 1

-1 -2 -1 -1 -4

6 6

19 3 2

-1 0 3 1

10 14

7 4

20

2 -0

2 0 0

-0 -1

1 -1 -1

3 0 2 2

-1 4

-1 -0 -1

0

1 4 3 9 3 2

-7 8 1

-1 2

1 2 655 -1 -0 660 -0 2 662

1 0 643 -2 0 654 -2 -0 624 -0 -2 668 -2 1 670 -5 -2 668

7 -1 592 6 3 622

11 21 -0 6S3 2 3 2 681

-s 2 2 668 5 -1 -2 587

-0 -1 4 573 2 3 -2 565 6 0 -0 SS2 4 11 -2 553

10 15 0 648 -1 3 9 -1 612

Room 3414 Floor Tile #257/476 (5# 7-11)

Room 3414 Floor Tile #258/477 (5# 12-16)

Lab Corridor Floor Tile #393/479 (5# 17-21)

Lab Corridor Floor Tile #394/480 (5#22-27)

Room 3419 Location

0 0 0 0 0 0 7 0 0 0 0 0 3 0 0 0 3 0 0 0 0 0 3 -4 4 3 621 #181/481

-2 13 23 -3 589 1

12 2.00 13 2. 00 14 2.00 15 2.00 16 2.00 17 2.00 18 2.00 19 2.00 20 2.00 21 2.00 22 2.00 23 2.00 24 2.00 25 2.00 26 2. 00 27 2.00 28 2.00 29 2.00 30 2.00 31 2.00 32 2.00 33 2.00

-2 8 1 1 -0 2 1 -0 656 0 (5#28-31)

-~---=~~~-=-~~~--=-~~~~~..::..:::..:_~-=-

34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 SS 56

2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00 2.00

Rev 1-30-2015

2 -2 -2 -1

1 1 1

-1 -1

2 3 1

-2 -1

0 5 2 1

-1 4

-1 -1 -1

1 -2

2 3 2

-1 3 1 2 1

-1 3 2 3 4

-o 5 3 7

15 2 1 1

-1 1 6 2

-i -~ : -i ~~~ 6Post Tile Removal 2

-1 1

-1 2

-1 -1 -1 -3

1 0

-3 -3 -1

1 1

-3 -1 -3

1 -2 -1 -2

-4 2 2 572 -1 -1 -1 601

2 3 1 486 2 2 -1 611 1 2 2 610

-2 2 -2 547 -2 -1 -1 563

5 3 -1 551 5 2 -4 593 0 4 1 598

-6 5 0 639 -2 0 -3 568 -0 6 -3 500

9 3 -2 644 3 7 1 634

-2 18 1 641 -2 3 -4 570

8 1 -1 650 -3 2 -4 663 -2 -1 1 618 -3 2 -2 613

0 7 -1 622 -5 3 -2 631

4 0 0 0 0 0 0 0 0 0 4 0 3 0 0 0 0 0 0 0 0 0 0

Room 3414 Floor Tile #263/478 (5# 32-36)

Room 3414 Floor Tile #257/476 (5# 37-41)

Room 3414 Floor Tile #258/477 (5# 42-46)

Lab Corridot Floor Tile #393/479 (5#47-51)

Lab Corridor Floor Tile #394/480 (5# 52-56)

81

Page 88: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

SURVEY METER CALIBRATION REPORTS

Rev 1-30-2015 82

Page 89: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. RSO Job No. Rl 1154 P.O. Box 1450 Laurel, MD 20725 (301) 953-2482 Certificate of Calibration

ISSUED TO: RSO, Inc. 5204 Minnick Road Laurel, MD 20707

CONTACT: Dave Wellner PHONE: (301) 953-2482 PO NO: RSO 299

INSTRUMENT: LUDLUM MODEL: 2221

TYPE: RATEMETER

SN: 161591

RSO, Inc. certifies that on 11/07/2014 the above described instrument was calibrated using a radioactive source to determine the efficiency for a specific radionuclide(s) and using electronically generated pulse for the linearity. Pulsed using Ludlum 500-2, SIN 159Jl0.

Notes

The results are tabulated below. Calibration is traceable to NIST.

ANALOG

SCALER

RANGE

DATA

DATA

Calibration Data EXPECTED

100 400

1000 4000

10000 40000

100000 400000

JOO 400

1000 4000

10000 40000

100000 400000

OBSERVED

100 cpm 395 cpm

1000 cpm 4010 cpm 9050 cpm

39000 cpm 100000 cpm 390000 cpm

101 cpm 395 cpm

1000 cpm 4010 cpm

10040 cpm 39930 cpm

100340 cpm 399841 cpm

C.F. AVERAGE

Probe type(s) Probel: PROPORTIONAL Probe2: Probe3:

c..E.. N.QTE

1.00 1.01 1.00 1.00 1.10 1.03 l.00 1.03 0.99 1.01 1.00 1.00 1.00 1.00 1.00 1.00 1.01

MODEL SERI WINDOW GEOMETRY VOLT ISOTOPE 1 EFF.(l') ISOTOPE 2 EFF.(%) ISOTOPE 3 BFF.(%) ISOTOPE 4 EFF.(%)

43-68 PR118227 FIXED CONTACT 1699 C14 21 Tc99 22

Threshold set to 35; Window set to OUT.

Note: •As Found• condition +/- 10"' of Expected values unless indicated.

INSTRUMENT CHECKS

BATTERY CHECK: NORMAL CHECK.SOURCE 1: C14 READING: 8642 cpm CHECK SOURCE 2: NIA READING:

Th230 27

ENVIRONMENTAL

TEMP: z4•c PRESS: 760 mmHg

HUMID: 32 91>

THE SUGGESTED RECALIBRATION DATE FOR THIS INSTRUMENT IS 11/07/2015 Calibrated By: ~ /, \.P ± /.U'p~

-~'"'-""""-' Reviewed By: V't"~ ~ racy Austin.

Cal Date: 11/0712014

Maryland License MD-33-021-01

Rev 1-30-2015

16004

83

Page 90: Incyte Corporation, Deficiency Response Letter Dated February 3, … · 2019. 12. 14. · Washington DC (301) 953-2482 WW\\ .rsoinc.com Baltimore (410) 792-7444 RSO, Inc. We have

RSO, Inc. RSO Job No.R10942 P.O. Box 1450 Laure~ MD 20725 (301) ~53-2482 Certificate of Calibration

ISSUED TO: RSO, Ine. 5204 Minnick Road Laurel, MD 20707

CONTACT: Dave Wellner PHONE: (301) 953-2482 PO NO: RSO 299

INSTRUMENT: LUDLUM MODEL: 2221

TYPE: RATEMETER

SN: 89650

RS01 Inc. certifies that on 06/1112014 the above described instrument was calibrated using a radioactive source to determine the efficiency for a specific radionuclide(s) and using electronically generated pulse for the linearity. Pulsed using Ludlum 500-2, S/N 159110.

Notes

MODEL

The results are tabulated below. Calibration is traceable to NIST.

ANALOG

SCALER

RANGE

DATA

DATA

Calibration Data EXPECTED

100 400

1000 4000

10000 40000

100000 400000

100 400

1000 4000

10000 40000

100000 400000

OBSERVED

100 cpm 400 cpm

1000 cpm 4000 cpm

10000 cpm 40000 cpm

100000 cpm 400000 cpm

103 cpm 402 cpm

1004 cpm 4003 cpm

10000 cpm 40001 cpm

100000 cpm 400001 cpm

C.F. AVERAGE

Probe type(s) Probel: PROPORTIONAL Probe2: Probe3:

c...E.. NQIE

l.00 1.00 l.00 1.00 1.00 1.00 1.00 l.00 0.97 1.00 1.00 1.00 1.00 1.00 l.00 1.00 t.oo

SERI WINDOW GEOMETRY VOLT ISOTOPE I EPP.(") ISOTOPE 2 EPP.(") ISOTOPE 3 EFF.(") ISOTOPE 4 EFF.(")

43-37 PR141921 FIXED CONTACT 1850 Cl4 18 Sr90 22 Tc99 18 Ni63 6

Threshold set to 60D; Window set to"OUT".

Note: •As Found" condition +/- 10% of Expected values unless indicated.

INSTRUMENT CHECKS

BATTERY CHECK: NORMAL CHECK SOURCE I: NIA READING: CHECK SOURCE 2: N/A READING:

ENVIRONMENTAL

TEMP: 25'C PRESS: 737 mmHg

HUMID: 44 %

THE SUGGESTED RE~ijJBRATION DATE FOR THIS INSTRUMENT IS 06/11/2015 Calibrated By: lfJ/U~~1 Reviewed By: ~ Cal Date: 06/11/2014

Dorsoy AUJlin Mayland License MD-33-021-01 15361

Rev 1-30-2015 84