enzon, inc., new license application, dtd 03/24/1993, control no. … · 2012. 11. 21. · nrc form...

- NRC FORM 313

1 THIS I S AN APPLICATION FOR IChUk .pPrDprute rnml

A NEWLICENSE

B AMENDMENT TO LICEHSE NUMBER

C RENEWAL OF LICENSE NUMBER 3

. .- - 1948' 10 CFR 3 0 . 3 1 . 33. 34.35 ."b 40

2 NAME A N 0 MAILING ADORES OF ACPLICAM /ld&Zb codrl

Enzon, Inc. 40 Kingsbridge Road Piscataway, NJ 08854-3998

APPL

3 FACILITIES AN0 EOUIPMENT

See Supplement D

See Supplement F I 1 WASTE MANAGEMENT

- U.8 NUCLCAR REOULATORV COMMIUION

APPROVED I V OM8

I O RADIATION SAFETY PROGRAM See Supplement E

12 LICENSEE FEES IS- rOCFR 170mds8etm f 7 0 J l l AMOUNT

FEE CATEGORY 3M lENCLOsE0 1 1,200 - 00

CATION FOR MATERIAL LiCENSE

030- 33 1 2 0 INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR D E T A I L E D INSTRUCTIONS FOR SEND TWO COPIES

OF THE ENTIRE COMPLETED APPLICATION TO THE N R C O F F I C E SPECIFIED BELOW.

APPLICATIONS FOR OlSTRlBUTlON OF EXEMPT PRODUCT8 FILE APPLICATIONS WITH:

US NUCLEAR REGULATORY COMMISSION DIVISION OF INOUSTRIAL AND MEDICAL NUCLEAR SAFETY, NMSS WASHINGTON, DC 20555

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS. IF YOU ARE LOCATED IN

CONNECTICUT DELAWARE. DISTRICT OF COLUMBIA, MAINE, M A R Y U N D . MASSACHUSETTS NEW HAMPSHIRE. NEW JERSEY. NEW VORK. PENNSYLVANIA. RHOOE ISLAND. OR VERMONT. SEND APPLICATIONS TO.

U S NUCLEAR RffiULATDRY COMMISSION, REGION I NUCLEAR MATERIALS SAFETY SECTION B 4% ALLENDALE ROAD KING OF PRUSSIA. PA !Iw)6

A U E A M A . FLORIDA. GEORGIA. KENTUCKY. MISSISSIPPI. NORTH CAROLINA. PUER70 RICO. SOUTH CAROLINA. TENNESSEE, VIROINIA. VIRGIN I L U N D S , OR WEST VIRGINIA. SEND APPLICATIONS TO

U S NUCLEAR REGULATORV COMMISSlOh. REGION II

101 M A R I m A STREn. SUITE 2900 ATLANTA. GA 30323

NUCEAR MATERIALS SAFETY SECTION a

IF VQU ARE LOCATED IN:

ILLINOIS, INDIANA, IOWA. MICHIGAN. MINNESOTA. MISSOURI. OMIO. OR WISCONSIN, SEND AWLICATIONS TO:

US. NUCLEAR REGUUTORY COMMISSION. REGION 111 MATERIALS LICENSING SECTION 799 ROOSEVELT ROAD GLEN ELLYN. I L 60137

ARKANSAS COLORADO IDAHO KANSAS LOUISIANA U O W A N A NEBRASKA.

OR WYOMING, SEND ACKICATIONS TO: NEW MEXICO. NORTH D~KOTA,~KI.AH&A, couw DAKOTA. r t k . UTAH.

US. NUCLEAR REGUUTORY COMMISSION, REGION I V MATERIAL RADIATION PROTECTION SECTION 611 RYAN PLAZA DRIVE. SUITE lo00 ARLINGTON,TX 78011

ALASKA ARIZONA CALIFORNIA HAWAII NEVADA, ORCOOY WUHIWON AND u.0: Tmai io i ia AND ros i r t l i~ '~~ TME PACIFIC. I E ~ AWLW~TIONS TO:

U.S. NUCLEAR REGULATORY COMMISSION. REGION V NUCLWR MATERIALS S A M SE-N 14W MARIA UNE. SURE 210 WALNUT CREEK. CA MES

FOR NRC USE ONLY r Y P E O F FEE FEE LOG - FEE CATEGORY COMMENTS

-t

kMOUNTRECElVE0 / I CHECK NUMBER

SUPPLEMENT A

1. Reference Item #5, NRC Form 313

ISOTOPE PHYSICAL FORM

Carbon- 14 Liquid Chromium-5 1 Liquid Hydrogen-3 Liquid Iodine- 125 Liquid Iodine- 13 1 Liquid P~OSP~OIUS-32 Liquid Sulfur-35 Liquid

MAXIMUM ACTIVITY

100 millicuries 50 millicuries

300 millicuries 50 millicuries 50 millicuries

200 millicuries 100 millicuries

2. Reference Item #6, NRC For 313

Materials listed in section #5 are for pharmaceutical research and development &. Radioactive materials will be used in the following types of research situations: In vitro cell proliferation assays (IT, and It=); in vitro cytotoxicity assays (H3, Cr“, and Its); radiolabeling of synthetic compounds and proteins (IT, C“, S”, I’25 and I”’), and labeling of cells or cell surfaces for receptor binding experiments (€P, S3’, It= and PI). DNA labeling and sequencing (P33 for cloning and in vitro gene expressions.

ISOTOPE

P

P

1131

H3

c"

SS

C?'

MAJOR RADIATION

SHIELDING

APPROXIMATE SHIELD ENERGIES Pb HVL

(MeV) (cm>

A = Lucite B = L d

14.3 days

59.4 days

8.0 days

HALF LIFE

B'

E.C.

P-

TYPE OF DECAY

Y

B'

0.179 B 0.0037 cm

0.971 B

12.3 years + 87.2 days

B'

27.2 days I E.C.

DECAY

p =beta

SUPPLEMENT A - continued

ISOTOPE INFORMATION

RADIATION

$' = beta particle E. C. = Electron Capture y = gamma ray

SPECIAL PRECAUTIONS

NaI form Volitile

Reference Item #7, NRC form 3 13

SUPPLEMENT B

1. Officer(s) follow.

The names of the Radiation Protection Officer and Alternate Radiation Protection

Carl W. Gilbert Christopher J. Molineaux Marc Whitlow Jack C. McLaughlin

2. Senior Scientists also will supervise day to day use of the isotopes are:

(1) Carl W. Gilbert (2) Christopher J. Molineaux (3) David Filpula (4) Marc Whitlow (5) Abraham M. Lasdun (6) Jack C. McLaughlin (7) Richard Greenwald (8) Barbara Czuba

NRC FORM 313M

SUPPLEMENT B

Training and Experience of Individuals Listed in Item 7

NAME: Carl W. Gilbert. Ph.D.

Social Security #

Q

Type of Training Where Trained Duration of Training On the Job Formal College

A.Principles practices of radiation protection

B.

C.

Radioactivity measurement standardization & monitoring techniques & instruments

Univ. of Illinois 1 Year Yes Urbana, IL

I T Univ. of Illinois 8 years Yes -1

Urbana, IL Michigan State Univ. E. Lansing, MI

Mathematics & calculations Univ. of Illinois basic to use and measurement of radioactivity

1 year @ No No Urbana, IL

D.Biological effects of Univ of Illinois 1 year @ No Yes @ radiation Urbana, IL

#8 Experience with Radiation (Actual Use of Radioisotopes or Equivalent Experience).

NAME: Carl W. Gilbert. Ph.D.

ISOtOpe Maximum Amount Where Experience Duration of Type of Was Gained Experience USe

'H & "C 1OOpCi . Dept. Biochemistry Univ. of Illinois

"P

"Cr

'H

50 mCi

5 mCi

10 mCi

Dept. of Physiology & Biophysics, Univ. of Illinois

Univ. of Colorado Health Science Center

DOE - Plant R M C h Michigan State Univ.

10 mCi Dept. of Microbiology Michigan State Univ.

5 mCi

50 mCi

10 mCi

Michigan State Univ. - lmmunotherapeutics

Im mu no therapeu tics Fargo, ND

Immunotherapeu tics Fargo, ND

2 years

5 years

2 years

3 years

2 Years

4 years

4 years

4 years

- in translation work

uslabedingofcell (in v i v ~ ) met - in*tr;prdatians

- in vitro DNA labeling

in & DNA B labeling -

clmTlidsynthess o f s p e c i f i c molecules

Charticalsynthess

vitro assays

of s p e c i f i c molecules and

(signature)

NRC FORM 313M

SUPPLEMENT B


NAME: Christopher J. Mo lineaux. Ph.D.

Social Security #


A.Principles practices Johns Hopkins of radiation Baltimore, MD protection USUHS 4 years

Bethesda, MD Mt. Sinai 6 years New York, NY

B. Radioactivity measurement standardization & monitoring techniques & instruments

C. Mathematics & calculations Jolm Hopkins 5 years basic to use and measure- Baltimore, MD

Bethesda, MD Mt. Sinai 6 years New York, NY

ment of radioactivity USUHS 4 years

D.Bio1ogical effects of Johns Hopkins 5 years radiation Baltimore, MD

USUHS 4 years Bethesda, MD Mt. Sinai 6 years New York, NY

@ No , @ No

@ No if?) No

@ No @ NO


NAME: ChrktoDher J. Molineaux. Ph.D.

Isotope Maximum Amount Where Experience Duration of Type of Was Gained Experience USe

I4C

‘‘c

32P

‘=I

50pCi USDA, Beltsville, MD 1 year

10 pCi

100 pCi

50 mCi

2 mCi

2 mCi

U. Notre Dame 1 Year South Bend, IN

Johns Hopkins 4 years Baltimore, MD

Johns H~pkins 4 years Baltimore, MD

USUHS 4 years Bethesda, MD

Mt. Sinai 6 years New York, NY

in vivo labeling of RNA

Intermediary metabolism

- in & enzyme assays

- in a acetylcholine assays

RIA’S

RIA’S

NRC FORM 313M

SUPPLEMENT B

Training and Experience

NAME: pan 'd Fihula

Social Security # -

Type of Training

A. Principles practices of radiation protection


C. Mathematics & calculations basic to use and measurement of radioactivity

D. Biological effects of radiation

Where Trained

univ. of Minnesota

univ. of Minnesota

univ. of Minnesota

Univ. of MiMeSOta

Duration of Training

4 years

4 years

4 Y-

4 years

On the Job

Yes

Yes

Yes

Yes

Formal College

YeS

YeS

YeS

YeS


NAME: David Filpula

Maximum Amount

1 mCi

0.1 mCi

1 mCi

1 mCi

1 mCi

Where Experience Was Gained

Univ. of Minnesota, Stanford Univ.,

A.C.S.D., Genex C O T


A.C.S.D., Genex COT

Univ. of Minnesota, Stanford Univ., A.C.S.D., Genex

COT


A.C.S.D., Genex COrP


A.C.S.D., Genex carp

Duration of Experience

8 years

8 years

8 years

8 years

8 years

Type of Use

Biological Research

Biological Research

Biological Research

Biological Research

Biological Research

(signature)

NRC FORM 313M

SUPPLEMENT B


NAME: JMarcWh itlow

Social Security # - . -

Type of Training





Where Trained

Brookhaven National Lab





1 day

1 day

On the Job

Yes

P

Yes

Yes

~

Yes

Formal College

No

_I_- -

No

No

No

OFFICIAL ItECORD COPY bfL 19, , 217911


NAME: Marcwh itlow

Brookhaven National Labs

Neutrons 6 weeks High Flux Beam Reactor

Station P3

, (signature)

I I I I

I

fyw of U r

I 1

i

I

NRC FORM 313M

SUPPLEMENT B


NAME: Avi Lasdun

Social Security # - r - 1 ,

I

Type of Training II A. Principles practices of radiation protection



D. Biological effects of radiation I

Where Trained

Duration of Training - On the Job Formal

College


NAME: AviLasdu n

Maximum Amount

1 '

Where Experience Was Gained

' \

' I

I 1

'I

Duration of Experience

Type of Use

' I

NRC FORM 313M

SUPPLEMENT B


NAME: bck C. McLat,yh lin -


A. Principles practices New Jersey College of radiation of Medicine protection Newark, NJ

B. Radioactivity New Jersey College maurement of Medicine standardization & Newark, NJ monitoring techniques & instruments

C. Mathematics & calculations Fairleigh basic to use and measurement of radioactivity Rutherford, NJ

Dickinson Univ.

D.Biological effects of Fairleigh radiation Dickinson Univ.

Rutherford, NJ

2 years @ No

6 No

@ No

Yes No c,

*


NAME: Jack C. Mchughlin

Isotope Maximum Amount Where Experience Duration of Type of Was Gained Experience Use

’H & “C 1oOpCi . New Jersey College 2 years in vitro

labeling of Medicine diagnostic

(?&f& A- (signature) ‘ l .

NFC FORM 313M

SUPPLEMENT B


NAME: Richard B. Greenwald. Ph.D.

Social Security # -

Type of Training Where I Trained





Duration of I On the Job 1 Formal Training College

:


NAME: Richard B. Greenwald. Ph.D.

(signature)

NRC FORM 313M

SUPPLEMENT B


NAME: B a r b ~ C z u b a

Social Security #

Type of Training I1 A. Principles practices of radiation protection I

i




Where Trained


On the Job

x x

K

~

k

Formal College -

x

x L d


NAME: BarbaraC zuba

Maximum Where Experience Duration of Amount I WasGained Experience

~~ ~

Type of Use

Reference Item #8, NRC Form 313

SUPPLEMENT C

1. All employees working in the facility will receive instruction concerning radiation safety, regardless of their level of use of radioactive materials.

2. All new researchers and technicians or other employees using or handling radioactive materials will be given a minimum of four hours training in proper handling techniques and radiation safety by the Radiation Protection Officer (RPO). Periodic training of employees handling radioactive material will be conducted by the RPO in accordance with Title 10, Code of Federal Regulations, Part 19 (lOCRF19).

3. Course Outline:

Radiation Training Course (4 Hours)

1 hour lecture on radiation theory.

1 hour lecture and demonstration on the use and handling of radioactive materials.

Half-hour video on radiation safety.

1 hour demonstration on radioactive safety, use of Gieger counters and scintillation counter.

Half-hour questions and answers.

Reference Item #9, NRC Form 313

SUPPLEMENT D

1. Enclosure 1 is a copy of the floor diagram for the Enzon, Inc. Research Laboratory at 20 Kingsbridge Road, Piscataway, NJ. Radioactive materials will be utilized only in the laboratory areas of this facility. Materials awaiting waste disposal will be kept in a secured area within the facility. All facilities are kept locked when not in use, and access is limited to the locked areas through limited key access. Neither the laboratory nor waste holding area has direct access to the public. All entrances to the laboratory and waste storage area will be posted in accordance with 10 CFR Parts 19, 20 and 21. Eating, smoking, drinking and the application of cosmetics in the controlled areas is strictly prohibited.

2. Enclosure 2 is a diagram of the laboratory, showing work stations. Supplies of plexiglass beta shielding and lead bricks and foil are kept on hand to ensure radiation exposure is kept as low as reasonably achievable (ALARA).

3. Two each beta/gamma (Geiger type) and beta (pancake type) survey meter detectors with appropriate meters are kept on hand at all times. The only exception to this rule is when one of the instruments is being calibrated (once every six months, percent maximum variance, two points per scale separated by at least 50% of the full scale). In this situation, only one each of the bedgamma and beta probes with appropriate meter(s) will be available.

10

4. All personnel working with or handling radioactive materials will be issued a whole body type film badge dosimeter. Personnel working with quarterly thyroid scans and have annual samples of their urine analyzed by an appropriately certified testing laboratory. All radiation workers will receive an annual physical examination including blood analysis, and thyroid palpitation to be conducted by competent medical personnel. Records of radiation exposure and bioassay results will be reviewed by the Radiation Protection Officer and maintained by Enzon’s Human Resources Department.

or I”’ will receive

Reference Item #lo, NRC Form 313 - amended 15 April 1993 - OPERATING PROCEDIJRE

=ATION OF R A D I O A m MATERIALS

1. PuRpoa To present rules and procedures for the use of radioactive materials in research conducted at ENZON, INC. To ensure that exposure of workers to ionizing radiation is kept as low as reasonably achievable (ALARA).

2. SCOPE; This Operating Procedure applies to all persons working with radioactive materials at ENZON, INC.

3. PROCEDURF 3: Z e 1Sllowing procedures will be used as a guideline for the ionizing radiation protection program:

A. ACOUISITION

1. All requests for radioactive material will be approved by the licensed Radiation Protection Officer @PO) or his designated alternate. Orders will be limited to the minimum amount of radioactive material required for the given research project.

Orders will be placed on a standard Enzon purchase order form and an Enzon REQUEST FOR PURCHASE ORDER (see Appendix A-1, form 12003).

2. Once approved by the RPO, orders for radioactive materials will be placed by the Purchasing Agent.

3. All shipment of radioactive material will be received at the loading dock by the Receiving Department. All packages will be carefully inspected to ensure there is no damage to any containers holding radioactive materials and that only the appropriate isotope(s) at the proper activity and chemical form have been received. All pachges will be monitored via Gieger counter (kept and maintained at receiving) to detect radiation leakage. External surfaces will be swiped, and the swipe counted (as necessary) to detect H3 and C". An Enzon RADIOISOTOPE RECEIVING FORM (see Appendix A-2, form 12004) will be filled out and package contents surveyed for radioactive spills.

4. Radioactive materials awaiting use will be stored in a controlled access area in a locked 4" C refrigerator or -20"' freezer as appropriate. These devices are clearly posted "Caution Radioactive Materials. "

B. UTIL IZATION

All research involving the use of radioactive materials will be reviewed and approved by the RPO prior to start-up. The FWO will review the proposed research protocol to ensure that: (a) adequate! radioactive materials for the project are on hand or can be ordered within the scope of the NRC license, (b) adequate shielding is available to ensure radiation exposure to workers is kept as low as reasonably achievable, and (e) adequately trained personnel are available to conduct the research in a safe and efficient manner.

All research involving the use of radioactive materials will be conducted behind appropriate shielding in designated isotope use areas. For high beta emitters (p" and S"), Plexiglas beta shielding is available and must be utilized. For the gamma emitter (Itu, and Cr"), lead foil (1116" or thicker and/or bricks are available for use and nrust be utilized.

All personnel working with any isotope will wear disposable gloves (at a minimum) when working with these materials.

Liquid waste materials will be p l a d in an appropriately shielded carboy container marked for this purpose. Each individual isotope will be stored in its own marked carboy container. Each time material is placed into the carboy, it will be annotated on the LIQUID WASTE DISPOSAL RECORD (see Appendix A-3, form 12005) on the carboy shield. Information will include isotope, activity, chemical form, date, and user.

Solid waste materials will be placed in the plexiglass boxes (beta sources) or the steel drum (beta and gamma) marked for this purpose. Each time material is placed into the solid waste container, it will be annotated on the log sheet SOLID WASTE DISPOSAL RECORD (see Appendix A-4, form 12006) at the container. Information will include isotope, activity, chemicaVphysical form, date, and user.

Eating, smoking, drinking and the application of cosmetics in areas where radioactive material is used or stored is strictly prohibited.

1.

2.

3.

4.

5.

6.

7.

C. DOSIMETRY

D. SURVE YS

All personnel working with radioactive materials or entering the radioactive materials work and/or storage areas will wear the company provided personnel dosimetry device (fdm badge). Badges are to be worn between the waist and shoulder on the outermost garment.

Badges are assigned to one person only for a given wearing period. Badges will never be shared by two or more persons.

Visitors approved for entry to the radiation areas by the RPO will be issued a visitors film badge and must wear the badge at all times while in the radiation areas.

Badges will be kept in the designated storage area only when not being worn. Badges will not be taken out of the building without the expressed written permission of the RPO.

Records of occupational exposure will be reviewed by the RPO, and kept by the Human Resources Department. In accordance with Title 29, Code of Federal Regulations, Part 1910, annual summaries of radiztion exposure will be given to each employee.

All users of P or II3' will have a quarterly thyroid scan and an annual urine sample analysis. Results of these tests will be kept with the film badge records.

All laboratory employees using radioisotopes will have an annual physical including blood analysis and thyroid palpitation with results of these physicals kept with the film badge records within the Human Resources department.

1.

2.

Weekly, a person appointed by the RSO will survey all laboratory work areas, including floors, with both the beta/gamma (Geiger) survey meter and the beta (pancake) survey detector. Wipe test smears will also be taken of the work areas weekly.

Personnel will immediately report any known or suspected spills of radioactive material to their supervisor and the RPO. Care will be given to minimize the spread of contamination to other persons and equipment. The bedgamma ana beta contamination instruments will be available at all times for emergencies. All clean-ups will be conducted under the supervision of the RPO.

1. All new laboratory employees will be presented training on the proper techniques in safe handling of radioactive materials and will know and understand all pertinent laboratory rules and regulations prior to commencing work involving radioactive materials. All current federal and state rules will be kept in the Library along with the Enzon Isotope Manual and will be available to all employees.

2. Periodic training of radiation workers, in accofdance with Title 10, Code of Federal Regulations, Part 19 will be conducted by the RPO for all persons working with radioactive materials.

F. EMERGENCY PROCE DURES

I. GENERAL

A radiation emergency occurs when a set of circumstances results in hazardous radiation levels, hazardous concentrations of airborne radioisotopes, or gross contamination of property or personnel. Each user is responsible for familiarizing those under hidher supervision with ;he proceilures in this section and any additional emergency procedures submitted by the RPO.

A. Treatment for Contaminated Accident Victims. Accident victims who are contaminated should be sent to the Robert Wood Johnson Medical Center for treatment. As soon as contamination is discovered, notify the RPO. If the victim is in need of immediate medical attention, call emergency personnel. The victim should be decontaminated as thoroughly as possible and as quickly as possible. Contaminated clothing should be removed, if possible, and retained for later examination by the RPO.

B. The Radiation Protection Officer should be notified ASAP.

Carl W. Gilbert, Ph.D. Ext. 2412 HOME PHONE

Jack C. McLaughlin Ext. 2432 Beeper HOMEPHONE - CAR PHONE

Marc Whitlow, Ph.D. WORK PHONE 908-980-4500

II. EXTREME HAZARDS

Extreme hazards; e.g., high radiation levels or the possibility of airborne contamination from dry or volatile radioactive materials. EVACUATE the laboratory immediately (if possible, turn off hoods, fans, etc.) close and lock the door or stand guard to prevent entrance. Have the RPO summoned immediately. (If you must leave the area to call, remove shoes if you suspect contamination and do not touch anything unnecessarily).

m. OTHERHAZARDS

Other hazards, e.g., spills or suspected spills of radioactive material where material does not become airborne. KEEP CALM, use common sense, protect people, do not spread contamination (always assume that you are contaminated until a survey proves differently) and use the following as guides:

1. Confine Contamination: Localize the spill. If the spill is a liquid and your hands are protected, set the container upright and drop absorbent material on the spill. Damp down a dry spill. Do not track contamination about the laboratory. CALL, DO NOT GO FOR HELP, IF POSSIBLE. Close doors and where possible adjust ventilation to prevent the spread of airborne contamination. Check shoes beiure leaving area of a cleaned-up spill.

3. Protect Personnel: Warn other workers. Carefully remove clothing and wash contaminated parts of the body with soap. Quickly and thoroughly flush out wounds under running water.

4. Decontaminate: If thorough washing with soap does not remove contamination from the body, consult with the RPO. You will be expected to perform the major work of decontamination of the area of your spill. With the RPO, devise a safe plan for reentry.

FOR ALL EMERGENCIES EXCEPT FOR VERY MINOR SPILLS OF RADIOACTIVE MATERIALS, THE RPO SHOULD BE NOTIFIED AS SOON AS POSSIBLE. HAVE THE OPERATOR PAGE CARL GILBERT. IF CARL GILBERT CANNOT BE FOUND TRY PAGING CHRIS MOLINEAUX OR JACK McLAUGHLIN.

V. FIRE

Usually, the radioactive materials possessed and small quantities used have no intrinsic danger would be possible breakage, spillage and spread of radioactive contamination. Employees must be aware of the flammable characteristics of the materials with which they must work (for example: diethyl ether, volatile hydrocarbons, etc.). Also, the possibility that certain

to cause fires or explosions. Secondary hazards to fires or explosions

I,

OFFICIAL RECORD COPY

m '5 4 e

c 4

a

an 6

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c

c

Rrl 22

ML 10 _ _ - ~ .

/ I 2 1 ' k_L f ILE r .-

DATE

SCAL i:'.V

I .: I -1 1

3-6-93

IY 1 rah

- ' sm #9 >plement D, Enclosure 1

Also Available On Aperture Card

1 -~

KiNGSBRIDGE ROAS PISCATAWAY, NE'SL' JERSEY

FLOOR PLAK J

117311

Reference Item #lo, NRC Form 313

SUPPLEMENT E

OPERATING PROCEDURE

FOR THE

UTILIZATION OF RADIOACTIVE MATERIALS

1. PURPOSE: To present rules and procedures for the use of radioactive materials in research conducted at ENZON, INC. To ensure that exposure of workers to ionizing radiation is kept as low as reasonably achievable (ALARA).

2. SCOPE: This Operating Procedure applies to all persons working with radioactive materials at ENZON, INC.

3. PROCEDURES: The following procedures will be used as a guideline for the ionizing radiation protection program:

A. ACOUISITION

1. All requests for radioactive material will be approved by the licensed Radiation Protection Officer (RPO) or his designated alternate. Orders will be limited to the minimum amount of radioactive material required for the given research project.

Orders will be placed on a standard Enzon purchase order form and an Enzon REQUEST FOR PURCHASE ORDER (see Appendix A-1, form 12003).

2. Once approved by the RPO, orders for radioactive materials will be placed by the Purchasing Agent.

3. All shipment of radioactive material will be received at the loading dock by the Receiving Department. All packages will be carefully inspected to ensure there is no damage to any containers holding radioactive materials and that only the appropriate isotope(s) at the proper activity and chemical form have been received. All packages will be monitored via Gieger counter (kept and maintained at receiving) to detect radiation leakage. External surfaces will be swiped, and the swipe counted (as necessary) to detect H’ and CI4. An Enzon

_-

RADIOISOTOPE RECEIVING FORM (see Appendix A-2, form 12004) will be filled out and package contents surveyed for radioactive spills.

4. Radioactive materials awaiting use will be stored in a controlled access area in a locked 4" C refrigerator or -20"' freezer as appropriate. These devices are clearly posted "Caution Radioactive Materials. 'I

B. UTILIZATION

1.

2.

3.

4.

5 .

All research involving the use of radioactive materials will be reviewed and approved by the RPO prior to start-up. The RPO will review the proposed research protocol to ensure that: (a) adequate radioactive materials for the project are on hand or can be ordered within the scope of the NRC license, (b) adequate shielding is available to ensure radiation exposure to workers is kept as low as reasonably achievable, and (c) adequately trained personnel are available to conduct the research in a safe and efficient manner.

All research involving the use of radioactive materials will be conducted behind appropriate shielding in designated isotope use areas. For high beta emitters (P" and S39, Plexiglas beta shielding is available and must be utilized. For the gamma emitter (Itz, I'31 and Cr"), lead foil (1/16" or thicker and/or bricks are available for use and must be utilized.

All personnel working with any isotope will wear disposable gloves (at a minimum) when working with these materials.

Liquid waste materials will be placed in an appropriately shielded carboy container marked for this purpose. Each individual isotope will be stored in its own marked carboy container. Each time material is placed into the carboy, it will be annotated on the LIQUID WASTE DISPOSAL RECORD (see Appendix A-3, form 12005) on the carboy shield. Information will include isotope, activity, chemical form, date, and user.

Solid waste materials will be placed in the plexiglass boxes (beta sources) or the steel drum (beta and gamma) marked for this purpose. Each time material is placed into the solid waste container, it will be annotated on the log sheet SOLID WASTE DISPOSAL RECORD (see Appendix A-4, form 12006) at the container. Information will include isotope, activity, chemical/physical form, date, and user.

Eating, smoking, drinking and the application of cosmetics in areas where radioactive material is used or stored is strictly prohibited.

C. DOSIMETRY

All personnel working with radioactive materials or entering the radioactive materials work and/or storage areas will wear the company provided personnel dosimetry device (film badge). Badges are to be worn between the waist and shoulder on the outermost garment.

Badges are assigned to one person only for a given wearing period. Badges will never be shared by two or more persons.

Visitors approved for entry to the radiation areas by the RPO will be issued a visitors film badge and must wear the badge at all times while in the radiation areas.

Badges will be kept in the designated storage area only when not being worn. Badges will not be taken out of the building without the expressed written permission of the RPO.

Records of occupational exposure will be reviewed by the RPO, and kept by the Human Resources Department. In accordance with Title 29, Code of Federal Regulations, Part 1910, annual summaries of radiation exposure will be given to each employee.

All users of sample analysis. Results of these tests will be kept with the film badge records.

or Ii3' will have a quarterly thyroid scan and an annual urine

All laboratory employees using radioisotopes will have an annual physical including blood analysis and thyroid palpitation with results of these physicals kept with the film badge records within the Human Resources department.

D. SURVEYS

1.

2.

Weekly, a person appointed by the RSO will survey all laboratory work areas, including floors, with both the beta/gamma (Geiger) survey meter and the beta (pancake) survey detector. Wipe test smears will also be taken of the work areas weekly.

Personnel will immediately report any known or suspected spills of radioactive material to their supervisor and the RPO. Care will be given to minimize the spread of contamination to other persons and equipment. The beta/gamma and beta contamination instruments will be available at all times for emergencies. All clean-ups will be conducted under the supervision of the RPO.

E. TRAINING

1. All new laboratory employees will be presented training on the proper techniques in safe handling of radioactive materials and will know and understand all pertinent laboratory rules and regulations prior to commencing work involving radioactive materials. All current federal and state rules will be kept in the Library along with the Enzon Isotope Manual and will be available to all employees.

2. Periodic training of radiation workers, in accordance with Title 10, Code of Federal Regulations, Part 19 will be conducted by the RPO for all persons working with radioactive materials.

F. EMERGENCY PROCEDURES

I. GENERAL

A radiation emergency occurs when a set of circumstances results in hazardous radiation levels, hazardous concentrations of airborne radioisotopes, or gross contamination of property or personnel. Each user is responsible for familiarizing those under hidher supervision with the procedures in this section and any additional emergency procedures submitted by the RPO.

A. Treatment for Contaminated Accident Victims. Accident victims who are contaminated should be sent to the Robert Wood Johnson Medical Center for treatment. As soon as contamination is discovered, notify the RPO. If the victim is in need of immediate medical attention, call emergency personnel. The victim should be decontaminated as thoroughly as possible and as quickly as possible. Contaminated clothing should be removed, if possible, and retained for later examination by the RPO.

B. The Radiation Protection Officer should be notified ASAP.

Carl W. Gilbert, Ph.D. Ext. 2412 HOME PHONE

Christopher J. Molineaux, Ph.D. Ext. 2428 HOMEPHONE :

Jack C. McLaughlin Ext. 2432 Beeper HOME PHONE '

CAR PHONE

- -

Marc Whitlow, Ph.D. WORK PHONE 908-980-4500

II. EXTREME HAZARDS

Extreme hazards;/e.g., high radiation levels or the possibility of airborne contamination from dry or volatile radioactive materials. EVACUATE the laboratory immediately (if possible, turn off hoods, fans, etc.) close and lock the door or stand guard to prevent entrance. Have the RPO summoned immediately. (If you must leave the area to call, remove shoes if you suspect contamination and do not touch anything unnecessarily).

111. OTHER HAZARDS

Other hazards, e.g., spills or suspected spills of radioactive material where material does not become airborne. KEEP CALM, use common sense, protect people, do not spread contamination (always assume that you are contaminated until a survey proves differently) and use the following as guides:

1. Confine Contamination: Localize the spill. If the spill is a liquid and your hands are protected, set the container upright and drop absorbent material on the spill. Damp down a dry spill. Do not track contamination about the laboratory. CALL, DO NOT GO FOR HELP, IF POSSIBLE. Close doors and where possible adjust ventilation to prevent the spread of airborne contamination. Check shoes before leaving area of a cleaned-up spill.

3. Protect Personnel: Warn other workers. Carefully remove clothing and wash contaminated parts of the body with soap. Quickly and thoroughly flush out wounds under running water.

4. Decontaminate: If thorough washing with soap does not remove contamination from the body, consult with the RPO. You will be expected to perform the major work of decontamination of the area of your spill. With the RPO, devise a safe plan for reentry.

FOR ALL EMERGENCIES EXCEPT FOR VERY MINOR SPILLS OF RADIOACTIVE MATERIALS, THE RPO SHOULD BE NOTIFIED AS SOON AS POSSIBLE. HAVE THE OPERATOR PAGE CARL GILBERT. IF CARL, GILBERT CANNOT BE FOUND TRY PAGING CHRIS MOLINEAUX OR JACK McLAUGHLIN.

V. FIRE

Usually, the radioactive materials possessed and small quantities used have no intrinsic danger per se to cause fires or explosions. Secondary hazards to fires or explosions would be possible breakage, spillage and spread of radioactive contamination. Employees must be aware of the flammable characteristics of the materials with which they must work (for example: diethyl ether, volatile hydrocarbons, etc.). Also, the possibility that certain electrical equipment can cause sparks or excessive heat should be realized, so that, as far as possible, departments should use explosion-proof refrigerators, centrifuges, motors, and the like.

The RPO is available for consultation and recommendations concerning fire prevention and assistance in establishing adequate controls.

In The Event Of Fire Or Explosion:

1.

2.

3.

4.

5 .

Activate the alarm within the building.

Call the Fire Department, 9-562-2333

Make sure the building is evacuated.

Have someone meet the Fire Department to show them where the fire is and to explain to them any possible hazards due to the presence of radioactive materials in the area.

If there is time, try to extinguish the fire with available equipment and, if possible, isolate radioactive materials from the source of the fire or explosion.

Reference Item 1 1, NRC Form 3 13

0.971

0.186

SUPPLEMENT F

~ __ ~ _ _

B

A

1 . Radioactive material, after the appropriate forms are signed, will be transferred from the RA storage area to the working laboratory in either plastic bottles/vials or lead shielded vials.

2. Radioactive waste materials will be collected in appropriate waste containers located in the laboratory and then transferred to the waste storage area. The waste storage area is a locked, controlled access area. Aqueous radioactive wastes will be held for radioactive decay until such time, as determined from the table below, or until there is no detectable radiation, they can be properly disposed of in the sanitary sewerage system in accordance with 10 CFR 20.303, or shipped for disposal. Other radioactive waste materials will be held until disposed of in accordance with 10 CFR 20.301 (a) or (b). Solid waste and organic waste will be disposed as required under a contract with a licensed radioactive waste disposal company (e.g., U.S. Ecology, P.O. Box 7246, 9200 Shelbyville Road, Louisville, KY 40207, TeledynelIsotopes, 50 Van Buren Ave., Westwood, New Jersey 07675, or other licensed source).

l-r ISOTOPE HALF

14.3 days

59.4 days

8.0 days

12.3 years

C14 I 5715 years

87.2 days

27.2 days

rTYPE OF DECAY

P- E.C.

P- 8'

P- E.C.

M A J O R c RADIATION

P-

Y

P- 8' B'

P- Y

\

I '

APPROXIMATE SHIELD SPECIAL ENERGIES Pb HVL PRECAUTIONS

(MeV) (cm)

1.710

0.179 0.0037 cm Volitile

0.156

0.167

0.751

SHIELDING: DECAY: RADIATION: A = Lucite@ p =beta y = gamma ray B = L e a d E.C = Electron Capture P' = beta particle

APPENDIX A

A-1 REQUEST FOR PURCHASE ORDER (12003)

A-2 RADIOISOTOPE RECEIVING FORM (12004)

A-3 SOLID WASTE DISPOSAL RECORD (12005)

A 4 LIQUID WASTE DISPOSAL RECORD (12006)

Adding EEI time UJ l@.' ENZON,I~~.

REQUEST FOR PURCHASE ORDER

This form must be completed and accompany the Purchase Requistion Form sent to the Radiation Protection Officer.

Requistion Order No. Date

Information on Requested Order Inventory

Principal Radioisotopes Activity (pCi, mCi, Physical and Chemical Form Activity on Hand* Ci) (pCi, mCi, Ci)

Expected delivery date, if known

*Corrected Decay activity of requested isotopes at time of procurement.

Expected delivery date, if known

*Corrected Decay activity of requested isotopes at time of procurement.

Signature of Authorized User

Signature of Radiation Protection Officer

A- 1

RADIOISOTOPE RECEIVING FORM

Principal Radioisotope(s) Physical and Chemical Form

Purchase Order No. P.O. Date

Activity (pCi, mci) Principal Radioisotope(s) Physical and Chemical Form

Activity (pCi, mci)

Survey of Incoming Shipment

Upon receipt the integrity of the package (was, was not) intact.

Date Received:

The contents of the inner package (agrees, disagrees) with the isotope and quantity listed on the packing slip.

If the integrity of the package was not intact or if the contents of the inner package disagrees with that given on the packing slip contact the Radiation Protection Officer immediately.

Contamination Survey Results

Package Exterior dpm/100 cm2 Inside Contents dpm/ 100cm2

Radiation Intensity of Container

Transport Index (mrem/hr at 3 feet) mrem/hr at surface of shipping container mrem/hr at surface of inner container

Storage location: Room Bldg.

Signature:

Isotopes are to be used only in experiments and locations for which its use has been approved by the Radiation Safety Officer.

COPY OF THIS COMPLETED FORM MUST BE SENT TO THE RADIATION PROTECTION OFFICER WITHIN 24 HOURS OF RECEIVING MATERIALS. 12004(4/1m)

A-2

LIQUID WASTE DISPOSAL RECORD AQUEOUS/ORG ANIC

Authorized User: Location:

Starting Date: Shipping Date:

Attach this form to the waste container and make the required entries for each disposal.

The authorized user must keep a file of these forms when they are removed from the waste container at the time of shipment.

The records must be available to the Radioactive Protection Officer upon request.

12u)s(4/lr93)

A-3

SOLID WASTE DISPOSAL RECORD

Authorized User:

Starting Date:

Drum No. *

Shipment Date:

This number is provided by the Radiation Protection Officer when the drum is picked-up.

Attach this form to the disposal drum and make the required entries for each disposal.

The authorized user must keep a file of these forms when they are removed from the disposal drum at the time of the shipment.

The records must be available to the Radiation Protection Officer upon request. 1 ~ 4 / 1 1 9 3 )

A 4

11’7911 OFFICIAC REcom COPY ML 10

enzon, inc., new license application, dtd 03/24/1993, control no. … · 2012. 11. 21. · nrc form...

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