Updated: 2005-11-29
Sec. 560.750 Guidance Levels for Radionuclides in Domestic and Imported Foods
(CPG 7119.14)
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.
- 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 Statespresents 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 shouldin
Agency guidances means that something is suggested or recommended, but not
required.
- 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.
- 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).
- REGULATORY ACTION GUIDANCE
FDA uses DILs to help determine whether domestic food in interstate commerce
or food offered for import into the United Statespresents 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 at www.fda.gov. 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. A district 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
| Radionuclide Group |
DIL
(Bq/kg) |
| Strontium-90 |
160 |
| Iodine-131 |
170 |
| Cesium-134 + Cesium-137 |
1200 |
| Plutonium-238 + Plutonium-239 + Americium-241 |
2 |
| Ruthenium-103 + Ruthenium-106c |
( C3 / 6800 ) + ( C6 / 450 ) <
1 |
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
