Draft Compliance Policy Guide

Compliance Policy Guidance for FDA Staff[^1]

Draft Guidance Levels for Radionuclides in Domestic and Imported Foods

**This draft guidance document is being distributed for comment purposes
only.**

Draft released for comment on January 13, 2004.

Comments and suggestions regarding this draft document should be
submitted by March 14, 2004 to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the Docket
number 2003D-0558. For questions regarding this draft document contact
Paul South (HFS-306) Center for Food Safety and Applied Nutrition
(CFSAN), (301) 436-1640.

> **U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition**

**January, 2004**

Draft Compliance Policy Guide

Draft Compliance Policy Guidance for FDA Staff

**Sec. 560.750 Guidance Levels for Radionuclides in Domestic and
Imported Foods (CPG 7119.14)**

*Additional copies are available from:*

*Office of Plants and Dairy Foods and Beverages*

*Division of Plant Product Safety, HFS-306*

*Center for Food Safety and Applied Nutrition*

*Food and Drug Administration*

*5100 Paint Branch Parkway*

*College Park, MD 20740*

*(Tel) 301-436-1640*

<http://www.fda.gov/ora>

**U.S. Department of Health and Human Services**

**Food and Drug Administration**

**Center for Food Safety and Applied Nutrition (CFSAN)**

**January, 2004**

Draft Compliance Policy Guide

Draft Compliance Policy Guidance for FDA Staff[^2]

**Sec. 560.750 Draft Guidance Levels for Radionuclides in Domestic and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.

**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 draft Compliance Policy Guide (CPG), if
finalized, will rescind and replace 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. BACKGOUND**

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 draft 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 draft 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 draft CPG, if finalized, will rescind and
replace 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 draft CPG are called DILs. DILs is an
internationally used term that will replace 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. 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 draft 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 Import^a,b^

+----------------------------------------+-----------------------------+
| Radionuclide Group                     | DIL                         |
+----------------------------------------+-----------------------------+
| Strontium-90                           | *(Bq/kg)*                   |
|                                        |                             |
|                                        | 160                         |
+----------------------------------------+-----------------------------+
| Iodine-131                             | 170                         |
+----------------------------------------+-----------------------------+
| Cesium-134 + Cesium-137                | 1200                        |
+----------------------------------------+-----------------------------+
| Plutonium-238 + Plutonium-239 +        | 2                           |
| Americium-241                          |                             |
+----------------------------------------+-----------------------------+
| Ruthenium-103 + Ruthenium-106^c^       | C~3~ + C~6~ \< 1            |
|                                        |                             |
|                                        | 6800 450                    |
+----------------------------------------+-----------------------------+

^a^The 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.

^b^Applicable 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.

^c^Due 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. C~3~ and C~6~ 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]{.underline}:

The article is adulterated within the meaning of 21 U.S.C. section
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]{.underline}:

The article is subject to refusal of admission pursuant to 21 U.S.C.
section 381(a)(3), in that it appears to be adulterated within the
meaning of 21 U.S.C. section 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]{.underline}:

The article is adulterated within the meaning of 21 U.S.C. section
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]{.underline}:

The article is subject to refusal of admission pursuant to 21 U.S.C.
section 381(a)(3), in that it appears to be adulterated within the
meaning of 21 U.S.C. section 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.

[^1]: This draft guidance has been prepared by the Office of Plant and
    Dairy Foods and Beverages in the Center for Food Safety and Applied
    Nutrition at the Food and Drug Administration. This draft guidance
    represents the Agency's current thinking on its enforcement process
    concerning the adulteration of food with radionuclides. It does not
    create or confer any rights for or on any person and does not
    operate to bind FDA or the public.

[^2]: This draft guidance has been prepared by the Office of Plant and
    Dairy Foods and Beverages in the Center for Food Safety and Applied
    Nutrition (CFSAN) at the U.S. Food and Drug Administration.