FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 1 of 9

For the most current and official copy, check QMiS.

Sections in This Document

1. Radiation Safety...................................................................................................................... 1

1.1. Electronic Products ........................................................................................................ 2

1.1.1. Microwave Digesters........................................................................................ 2

1.1.2. LASERs ........................................................................................................... 2

1.1.3. Analytical X-ray systems.................................................................................. 3

1.1.4. Scanning Electron Microscopes....................................................................... 3

1.2. Radioactive Material....................................................................................................... 4

1.2.1. Specifically Licensed Radioactive Material ...................................................... 4

1.2.2. Generally Licensed Radioactive Material......................................................... 4

1.2.3. Exempt Distributed Licensed Radioactive Material.......................................... 5

2. Radionuclides in Foods Program ......................................................................................... 6

2.1. Procedures in the Radionuclides in Foods Program...................................................... 6

2.2. Training......................................................................................................................... 7

3. Radiation Detection Instrumentation.................................................................................... 7

3.1. Radionuclide Laboratory Equipment.............................................................................. 7

3.2. Training......................................................................................................................... 8

Document History ..................................................................................................................... 8

Change History......................................................................................................................... 9

Attachments.............................................................................................................................. 9

1. Radiation Safety

The purpose of this section is to ensure that everyone working in the 

laboratory environment is aware of the radiation sources which might be 

present in the laboratory. Common Radiation sources which might be present 

in the laboratory will be enumerated and in so doing, policies and procedures 

to ensure that any radiation exposures are kept as low as reasonably 

achievable will be discussed. 

Laboratorians may be exposed to both ionizing (i.e., possessing enough 

energy to strip electrons from atoms) and non-ionizing radiations in the 

performance of their work. These radiations may be electromagnetic in nature 

(e.g., radiofrequency, optical, x-rays and gamma rays) or particulate (i.e., 

alpha and beta particles). The sources of the radiations may be radiation 

emitting electronic products or radioactive material. Many laboratory 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 2 of 9

For the most current and official copy, check QMiS.

operations require the use radioactive material (e.g., Uranyl acetate as a 

microbiological stain) or radiation emitting electronic products (e.g., microwave 

digesters). The following section will provide information on the safe use of 

these products and additional training references. 

This section pertains to all analysts, technicians, microbiologists, and 

engineers who work in a laboratory setting as well as their supervisors and 

managers. Radiation safety is everyone’s responsibility. 

Further information on radiation safety can be found on the ORA Safety 

SharePoint Site. 

This section will first cover electronic products and provide guidance on their 

safe use; a similar pattern will be used in the discussion of the radioactive 

material. It should be noted that unlike radioactive material, electronic products 

such as x-rays or lasers do not pose a safety hazard when powered off.

For a detailed list of training requirements for materials or devices with 

radiation hazards, see ORA Radiation Safety Manual (ORA.006).

1.1. Electronic Products

1.1.1. Microwave Digesters 

Microwave Digesters use radiofrequency radiation to digest samples. They 

produce microwaves at a frequency of 2450 Megahertz. These units may 

resemble a typical microwave oven, however there is no federal performance 

standard for these units. The biological effects of microwave radiation are 

thermal in nature (i.e., erythema and cataractogenesis). To prevent exposure 

to microwaves, follow the user manual and ensure that the door gasket is 

clean and that the door is not loose prior to use. Interlocks should be checked 

in accordance with the user manual. Microwave leakage should be checked 

annually and should not exceed 5mW/cm2. See ORA Radiation Safety Manual 

(ORA.006) for details. 

1.1.2. LASERs 

Lasers serve many purposes in the laboratory. They emit electromagnetic 

radiation ranging from far infrared region to the far ultraviolet region (1000 μm 

to 180 nm). A federal performance standard does exist for laser products and 

ANSI Standard Z136.1 address the safe use of lasers, which is the basis of 

ORA Safety Policy. Laser products are classified by the hazard they present. 

Class 1 laser products are inherently safe. Class 2 lasers emit visible light and 

depend on the eye’s aversion reaction (~0.25 seconds) to restrict exposure. 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 3 of 9

For the most current and official copy, check QMiS.

The maximum power for a Class 2 laser is 1 mW. Class 3 laser products have 

a maximum power output of 5 mW. Class 3B lasers have beams whose power

ranges between 5 and 500 mW. Class 4 lasers have outputs more than 500 

mW. When using Class 3B and Class 4 lasers the use of proper eyewear is 

mandatory. See ORA Radiation Safety Manual (ORA.006) for details. 

It should be noted here that a Class 1 laser product may contain a Class 3B or 

4 lasers. If an operation requires that the laser needs to be removed from its

protective housing, proper signage and precautions must be taken. See ORA 

Radiation Safety Manual (ORA.006) for details.

The biological effects from laser exposure are dependent on the wavelength of 

the optical radiation emitted. The eye is the critical organ, skin can also be 

affected by the beam. In addition to beam hazards, collateral hazards also 

exist with the use of high-powered lasers. These include electrical hazards, 

collateral radiation hazards and laser generated air contaminants (LGAC).

Laser products in the laboratory commonly include:

A. Laser cutters

B. Laser ablation units

C. Laser microscopes

D. Raman mass spectrometers

E. Positioning lasers

1.1.3. Analytical X-ray systems 

Analytical X-ray systems include x-ray fluorescence units (XRF) and x-ray 

diffraction units (XRD). The radiation emitted by these devices is classified as 

ionizing. All users of these devices shall wear ring and whole-body dosimeters 

when working with the device. The ring badge should be worn on the dominant 

hand. Users of these systems should be familiar with the user manual and 

must check interlocks regularly as described in the manual. XRF and XRD 

units must be tested for leakage at regular intervals, the user manual 

describes the frequency at which these units must be monitored. Leakage 

radiation should be no greater than 0.25 mRem/hr at 5 cm from any accessible 

surface of the analytical x-ray unit. See ORA Radiation Safety Manual 

(ORA.006) for details. 

1.1.4. Scanning Electron Microscopes 

Scanning Electron Microscopes can produce x-rays and should be monitored 

on a regular basis – yearly and after maintenance. Additionally, the user 

should be familiar with the user manual and perform all checks and 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 4 of 9

For the most current and official copy, check QMiS.

maintenance in accordance with the manual. Stray radiation from the electron 

microscope should not exceed 0.5 mRem/hr at 5 cm from any accessible 

surface of the unit. See ORA Radiation Safety Manual (ORA.006) for details. 

Note: analytical x-ray systems and electron microscopes produce low energy 

x-rays and special detectors are required to survey the units. The individual 

performing the surveys must be a qualified expert.

1.2. Radioactive Material

Safety regulations pertaining to radioactive material at ORA fall under distinct 

Nuclear Regulatory Commission (NRC) or Agreement State Licensure types. 

Each licensure type has unique regulations that specify safety procedures and 

possession requirements. Therefore, it is crucial for facilities to have an 

accurate inventory of radioactive material which includes licensure category. 

For more information, see ORA Radiation Safety Manual (ORA.006). 

Facilities may possess radioactive material under one of the following NRC 

licensure types: 1) NRC Specific License, 2) NRC General License, 3) Exempt

Distribution License. Typically, ORA facilities possess radioactive material that 

fall under General or Exempt Distributed Licenses. 

1.2.1. Specifically Licensed Radioactive Material

ORA holds an NRC Broad Scope Type A License that allows the Winchester 

Engineering and Analytical Center (WEAC) to use loose forms of alpha, beta, 

and gamma emitters. All ORA locations specifically listed under this license 

must follow all safety instructions stated in the license (e.g., authorized use, 

training, disposal). For requests to be added to the license, please contact 

ORA’s Health Physicist whose contact information is available on the ORA 

Safety SharePoint Site. 

In addition to the radioactive material authorized for use at WEAC, ORA’s NRC 

License authorizes the use of tritium labeled Saxitoxin at the following 

laboratories:

A. ORA Northeast Laboratory 

B. ORA Pacific Northwest Laboratory

For details on the Tritium in Saxitoxin Safety Procedures and training 

requirements see Radiation Safety Manual – Saxitoxin (SOP-000350)

1.2.2. Generally Licensed Radioactive Material

NRC Generally Licensed radioactive material typically includes radioactive 

material contained in a sealed source within a shielded device or capsule. 

These devices are designed with inherent radiation safety features, so they 
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 5 of 9

For the most current and official copy, check QMiS.

can be used by persons with limited or no radiation training or experience and 

are typically found in the following laboratory instruments or supplies:

A. Electron Capture Detectors (ECD) in Gas Chromatographs (GC) 

containing Ni-63

B. Ion Mobility Spectrometers (IMS) containing Ni-63

C. Liquid Scintillation Counters containing a built-in source (i.e., Co-60, Cs137, Eu-152) 

D. X-ray fluorescence units (XRF) containing a gamma emitter (i.e., Cd109)

E. Static eliminators containing Po-210

F. In-vitro laboratory kits containing H-3 or C-14.

G. Small quantities of Thorium or Uranium (see 10 CFR 40.22) greater 

than 0.05% by weight but less than 1.5 kg.

H. Radium in quantities less than 1 microCi (see 10 CFR 31.12) 

End-users automatically become General Licensees when they purchase 

these instruments and are required to comply with NRC Regulations (See 10 

CFR 31) regarding the registration, leak testing, transfer, reporting, and 

disposal of these Radioactive materials. In addition to NRC regulations, ORA 

radiation safety policies that include procuring, utilizing, labeling, storing, 

surveying, tracking, disposing as well as training and dosimetry requirements 

must be followed by lab personnel. See ORA Radiation Safety Manual 

(ORA.006) for details. 

1.2.3. Exempt Distributed Licensed Radioactive Material

Some manufacturers hold an NRC Exempt Distribution License and produce 

radioactive materials that are exempted from licensing requirements. The NRC 

deems that using these products does not constitute an unreasonable risk to 

public health and safety and the environment. Radiation safety features are 

built into the sealed source or device or the amount of radioactive material that 

can initially be distributed in such a device is restricted. Typical Exempt 

Distribution radioactive materials in the laboratory include:

A. Radioactive Check sources containing a gamma emitter (i.e., Cs-137)

B. Liquid scintillation calibration and quality standards (i.e., H-3 and C-14)

C. Some types of Ion Mobility Spectrometers containing Ni-63.

D. Very small quantities of loose radioactive material
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 6 of 9

For the most current and official copy, check QMiS.

Although, there are no formal regulatory requirements for exempt-distributed 

material, ORA radiation safety policies that include procuring, utilizing, 

labeling, storing, surveying, tracking, disposing as well as training and 

dosimetry requirements must be followed by lab personnel. See ORA 

Radiation Safety Manual (ORA.006) for details. 

2. Radionuclides in Foods Program

2.1. Procedures in the Radionuclides in Foods Program

This section is to inform analysts of the various procedures in the 

Radionuclides in Foods Program. Procedures are conducted safely in 

accordance with the WEAC Radiation Safety Manual (WEAC-LAB-RS.002). 

The food program may include, but is not limited to, the following training 

assignments:

A. Gamma Analysis

1. “Determination of Gamma-Emitting Radionuclides in Foods by HighPurity Germanium Spectrometry” (WEAC-RN-Method.3.0)

2. “Determination of γ-ray Emitting Radionuclides in Food Matrices 

Using Cerium Bromide γ-ray Spectrometry” (WEAC-AB-TM.005) 

3. “Determination of Food-Specific Efficiency Calibrations for GammaEmitting Radionuclides in High Purity Germanium Spectrometry” 

(WEAC-AB-TM.003)

B. Sr-90 Analysis

1. “Determination of Strontium-90 in Foods by Internal Gas-Flow 

Proportional Counting” (WEAC-RN-Method.2.0)

2. “Analysis of Strontium-90 in Food by Liquid Scintillation Counting” 

(SOP-000450)

3. “Generation of Yttrium-90 Efficiency Attenuation Curve Using Sr 

Resin Extraction Chromatography” (WEAC-AB-TM.002)

C. Tritium Analysis

1. “Determination of Tritium in Foods” (WEAC-RN-Method.8.0)

D. Gross Alpha/Beta Analysis
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 7 of 9

For the most current and official copy, check QMiS.

1. Analysis of 241Am, 238, 239, 240Pu, and 90Sr in Foods by SolidPhase Extraction Liquid Scintillation Counting (WEAC-RNMethod.7.0)

E. Other Analytical Methods

1. "Analysis of Polonium-210 in Food Products by Isotope-Dilution 

Alpha Spectrometry" (WEAC-RN-Method.4.0)

2. "Analysis of Americium-241 in Food Products by Isotope-Dilution 

Alpha Spectrometry" (WEAC.RN.Method.5.0)

3. "Analysis of Plutonium-238 and-(239+240) in Food Products by 

Isotope-Dilution Alpha Spectrometry" (WEAC-RN-Method.6.0)

2.2. Training

Analysts must be trained and authorized to perform methods on WEAC’s 

scope of accreditation and additional analyses as described in WEACQMS.5.2 and in accordance with the WEAC Radiation Safety Manual (WEACLB-RS.002)

Additionally, analysts performing in house calibrations must also be trained 

and authorized to perform the calibration procedures. Job specific training for 

individual analyses can be found in the references above for the specific work.

3. Radiation Detection Instrumentation

3.1. Radionuclide Laboratory Equipment

This section will familiarize the trainee with the radionuclide laboratory 

equipment. The equipment may include, but not limited to, the following 

instrumentation:

A. Gamma Detection

1. "The Canberra APEX Operated High-Purity Germanium GammaRay Spectrometer" (WEAC-AB-RN.12.0)

B. Alpha/Beta Detection

1. "Gas-Flow Low-Level Alpha/Beta Proportional Counter" (WEAC-ABRN.019)

2. "PerkinElmer Quantulus GCT 6220 Liquid Scintillation Counter" 

(SOP-000281)

3. "PerkinElmer Quantulus 1220 Liquid Scintillation Counter" (WEACAB-RN.15.0)
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 8 of 9

For the most current and official copy, check QMiS.

4. "Integrated Alpha Spectrometric System" (WEAC-AB-RN.16.0)

C. Isotopic Determination 

1. "Agilent 7700x Quadrupole Inductively Coupled Plasma Mass" 

(WEAC-AB-RN.018)

3.2. Training

Analysts must be trained and authorized to perform methods on WEAC’s 

scope of accreditation and additional analyses as described in WEACQMS.5.2 and in accordance with the WEAC Radiation Safety Manual (WEACLB-RS.002). 

Additionally, analysts performing in house calibrations must also be trained 

and authorized to perform the calibration procedures. Job specific training for 

individual analyses can be found in the references above for the specific work.

Document History

Revision

#

Status*

(D, I, R) Date Author Name and Title Approving Official Name and Title

1.2 R 02/06/2012 LMEB LMEB

1.3 R 02/14/2013 LMEB LMEB

02 R 06/30/2020 LMEB LMEB

03 R SEE QMIS 

ELON MALKIN, HEALTH 

PHYSICIST, SRMS

KATHRYN EMANUELE, KELLY 

GARNICK, & ANTHONY 

WETHERBY (CHEMISTS,

OMPTSLO/WEAC/AB)

LMEB

* - D: Draft, I: Initial, R: Revision
FOOD AND DRUG ADMINISTRATION

OFFICE OF REGULATORY AFFAIRS

Office of Regulatory Science

Document Number:

MAN-000065

Revision #: 03

Revised: 

27 Jul 2022

Title: 

ORA Lab Manual Vol. IV Section 12 - Radiation Safety and Radioactive 

Material Analysis in the Laboratory (IV-12)

Page 9 of 9

For the most current and official copy, check QMiS.

Change History

Revision 

# Change

1.2

Table of Contents – deleted Quality Assurance/Quality Control; added Document 

History

Section12.1 Introduction – revised

Section 12.2 C. – Questions 7. and 9. revised; added 10. and 11.

Section 12.2 D. – References 1. and 2. updated; added WEAC Radiation Safety 

Manual SOP

Section 12.3 B. – Bullets 1, 2., and 5. revised; added ICPMS

Section 12.3 C. – deleted 2.

Section 12.3 D. – updated 1. and 2.; added WEAC Radiation Safety Manual SOP

Section 12.4 A. and B. – revised

Section 12.4 C. - deleted 2. and 5.

Section 12.4 D. – updated 9.

Section 12.5 A. and B. – revised

Section 12.5 C. – updated 9.

Section 12.6 – deleted

Section 12.7 Answer Key (now 12.6) – added 10. and 11. to 12.2; deleted 2. from 

12.3; deleted 2. and 5. from 12.4; deleted 12.6

1.3 Header – Division of Field Science changed to Office of Regulatory Science

02 Section 1: expanded to include different categories of radiation producing devices 

and radioactive materials

03 Removed question and answer sections. Replaced with training and safety references.

Attachments

None