CPG Sec. *555.880 Guidance Levels for 
Radionuclides in Domestic and Imported 
Foods* 
This guidance document represents the Food and Drug Administration's (FDA's) current thinking 
on this topic. It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public. 
I.  INTRODUCTION 
The purpose of this document is to present guidance levels for radionuclide activity 
concentration, called derived intervention levels (DILs), which FDA has adopted to help 
determine whether domestic food in interstate commerce or food offered for import into the 
United States presents a safety concern. This Compliance Policy Guide (CPG) rescinds and 
replaces CPG Sec. 560.750 Radionuclides in Imported Foods  Levels of Concern (CPG 
7119.14). 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
II.  BACKGROUND 
In the Federal Register of June 25, 1986 (51 FR 23155), after the Chernobyl nuclear accident, 
FDA issued a Compliance Policy Guide (CPG) Sec. 560.750 Radionuclides in Imported Foods 
 Levels of Concern (CPG 7119.14) (hereinafter 1986 FDA guidance), which establishes 
guidance levels called "Levels of Concern" (LOCs) for radionuclide activity concentration in 
food offered for import. FDA staff considers the 1986 guidance levels when deciding whether to 
recommend detention of food offered for import into the United States. In the Federal Register of 
August 13, 1998 (63 FR 43402), FDA announced the availability of a new document entitled 
"Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations 
to State and Local Agencies" (hereinafter 1998 FDA document). The 1998 FDA document 
provides broader and more current information regarding radionuclides in food, and recommends 
new guidance levels for radionuclide activity concentration in food called Derived Intervention 
Levels, or DILs. 
III.  DISCUSSION  In this CPG, FDA has adopted DILs that were recommended in the 1998 FDA document as 
guidance levels for radionuclide activity concentration in food offered for import. FDA also has 
adopted these same guidance levels for radionuclide activity concentration for domestic food in 
interstate commerce. Previously, FDA had not established guidance levels for radionuclide 
activity concentration for domestic food in interstate commerce. In addition, the scope of 
coverage of the 1986 FDA guidance, which included food accidentally contaminated with 
radionuclides, has been expanded in this CPG to food that is accidentally or intentionally 
contaminated with radionuclides. These changes were made to ensure that FDA staff has 
appropriate guidance to address an incident involving food accidentally or intentionally 
contaminated with radionuclides, whether in domestic interstate commerce or offered for import. 
This CPG rescinds and replaces the 1986 guidance (i.e., CPG Sec. 560.750 Radionuclides in 
Imported Foods  Levels of Concern (CPG 7119.14)). The 1998 FDA document is unaffected 
by this CPG. Consistent with the terminology used in the 1998 FDA document, guidance levels 
for radionuclide activity concentration in this CPG are called DILs. DILs is an internationally 
used term that replaces the previous FDA term "Levels of Concern" (LOCs). 
IV.  REGULATORY ACTION GUIDANCE 
FDA uses DILs to help determine whether domestic food in interstate commerce or food offered 
for import into the United States presents a safety concern. Analytical methods used to determine 
radionuclide activity concentration are referenced in FDA's Compliance Program entitled "Toxic 
Elements in Food and Foodware and Radionuclides in Food" which is available on FDA's 
website. FDA determines whether foods contain unsafe levels of radionuclides on a case-by-case 
basis, considering the totality of the circumstances and the extent to which those circumstances 
depart from the assumptions that underlie the derivation of DILs. The DILs adopted in this CPG 
are not binding on FDA, the regulated industry, or the courts. In any given case, FDA may 
decide to initiate an enforcement action against food with concentrations below the DILs or 
decide not to initiate an enforcement action against food with concentrations that meet or exceed 
the DILs. The appropriate Program Field Office is to contact CFSAN/Office of 
Compliance/Division of Enforcement (HFS-605) for a preliminary assessment regarding the use 
of a DIL in a given case. The DILs that FDA may use to help determine whether foods contain 
unsafe levels of radionuclides are listed in the following table: 
Derived Intervention Levels (DILs) for Each Radionuclide Group for Food in Domestic 
Commerce and Food Offered for Importa,b 
DIL 
Radionuclide Group 
(Bq/kg) 
Strontium-90  160 
Iodine-131  170  DIL 
Radionuclide Group 
(Bq/kg) 
Cesium-134 + Cesium-137  1200 
Plutonium-238 + Plutonium-239 + Americium-241  2 
Ruthenium-103 + Ruthenium-106c  ( C  / 6800 ) + ( C  / 450 ) < 1 
3 6
aThe DIL for each radionuclide group is applied independently. Each DIL applies to the sum of 
the concentrations of the radionuclides in the group at the time of measurement. 
bApplicable to foods as prepared for consumption. For dried or concentrated products such as 
powdered milk or concentrated juices, adjust by a factor appropriate to reconstitution, and 
assume the reconstitution water is not contaminated. For spices, which are consumed in very 
small quantities, use a dilution factor of 10. 
cDue to the large differences in DILs for Ruthenium-103 and Ruthenium-106, the individual 
concentrations of Ruthenium-103 and Ruthenium-106 are divided by their respective DILs and 
then summed. The DIL for the Ruthenium group is set at less than one. C3 and C6 are the 
concentrations, at the time of measurement, for Ruthenium-103 and Ruthenium-106, 
respectively. 
SPECIMEN CHARGES: 
For legal actions based on analytical determination that radionuclides are present in the food: 
Domestic seizure: 
The article is adulterated within the meaning of *21 U.S.C. 342(a)(1)* in that it bears or contains 
an added poisonous or deleterious substance, namely radionuclides, which may render the article 
injurious to health. 
Import detention: 
The article is subject to refusal of admission pursuant to *21 U.S.C. 381(a)(3),* in that it appears 
to be adulterated within the meaning of *21 U.S.C. 342(a)(1)* because it bears or contains an 
added poisonous or deleterious substance, namely radionuclides, which may render the article 
injurious to health. 
For legal actions based on evidence that the situation or environment associated with the food 
may have caused the food to be contaminated with radionuclides: 
Domestic seizure:  The article is adulterated within the meaning of *21 U.S.C. 342(a)(4)* because it was prepared, 
packed, or held under insanitary conditions in which contamination with radionuclides may have 
rendered the article injurious to health. 
Import detention: 
The article is subject to refusal of admission pursuant to *21 U.S.C. 381(a)(3),* in that it appears 
to be adulterated within the meaning of *21 U.S.C. 342(a)(4)* because it was prepared, packed, 
or held under insanitary conditions in which contamination with radionuclides may have 
rendered the article injurious to health. 
1This guidance has been prepared by the Office of Plant and Dairy Foods in the Center for Food 
Safety and Applied Nutrition (CFSAN) at the U.S. Food and Drug Administration. 
*Material between asterisks is new or revised.* 
Issued: 06/01/1986 
Revised 07/19/1989 
Revoked/Renamed/Reissued: 07/29/2004 
Revised: 5/2005 
Updated: 11/29/05 
Updated: 11/19/20