Supporting Document for Guidance Levels for Radionuclides in Domestic
and Imported Foods

\[Docket No. 2003D-0558\]

Prepared January 2004

Food and Drug Administration

Center for Food Safety and Applied Nutrition

Office of Plant and Dairy Foods and Beverages

## Table of Contents

I. Introduction

II\. Protective Action Guides

III\. FDA's Guidance Levels for Radionuclide Activity Concentrations in
Food Established in 1986

IV\. FDA's 1998 Guidance Levels for Radionuclide Activity Concentration
in Food Contained in the Draft CPG

V. Appendix

VI\. References

# I. Introduction

In the Federal Register of August 13, 1998 (63 FR 43402) (FDA 1998), 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) replacing an earlier 1982 FDA document (FDA 1982). The 1998
FDA document provides guidance to State and local agencies to aid in
emergency response planning and execution of protective actions
associated with production, processing, distribution, and use of human
food and animal feeds accidentally contaminated, e.g., due to a nuclear
power plant accident, with radioactive elements called radionuclides. In
addition, the 1998 FDA document provides broader and more current
information regarding radionuclides in food than did the 1982 FDA
document.

FDA has adopted guidance levels for radionuclide activity concentration
established in the 1998 FDA document in a draft Compliance Policy Guide
(CPG) entitled "Guidance Levels for Radionuclides in Domestic and
Imported Foods." The draft CPG, if finalized, will rescind and replace
guidance levels for radionuclide activity concentration in food offered
for import established in current CPG Sec. 560.750 Radionuclides in
Imported Foods -- Levels of Concern (CPG 7119.14) with guidance levels
established in the 1998 FDA document. FDA has also adopted these same
guidance levels for radionuclide activity concentration for domestic
food in interstate commerce. Additionally, FDA has expanded its policy
from food accidentally contaminated with radionuclides to food
accidentally or intentionally contaminated with radionuclides. The 1998
FDA document remains unaffected by issuance of the draft CPG.

FDA uses guidance levels for radionuclide activity concentration in food
to help determine whether domestic food in interstate commerce or food
offered for import into the United States presents a safety concern. The
purpose of this supporting document is to present information taken from
the 1998 FDA document that explains the basis for the guidance levels in
the draft CPG, and to explain how these guidance levels differ from
guidance levels established in 1986, which have been superceded.

# II. Protective Action Guides

The calculation of guidance levels for radionuclide activity
concentration in food depends in part on Protective Action Guides
(PAGs). PAGs are radiation dose levels to an individual at which
protective action should be considered to limit the radiation dose to
that individual. PAGs were previously defined in the1982 FDA document as
"projected dose commitment values to individuals in the general
population that warrant protective action following a release of
radioactive material." In this context, the phrase "dose commitment"
refers to the radiation dose received by an individual. The PAGs
contained in the 1982 FDA document were developed from the prevailing
scientific understanding of the relative risks associated with radiation
as described in the 1960 and 1961 reports of the Federal Radiation
Council (FRC 1960, 1961). The 1982 FDA guidance document established two
levels for PAGs. The lower level, called the Preventative PAG, was a
projected dose commitment of 5 mSv to the whole body, active bone
marrow, or any other organ except the thyroid, or a projected dose
commitment of 15 mSv to the thyroid. The upper level, called the
Emergency PAG, was a projected dose commitment of 50 mSv to the whole
body, active bone marrow, or any other organ except the thyroid, or a
projected dose commitment of 150 mSv to the thyroid.

The 1998 FDA document redefined a PAG as the \"committed effective dose
equivalent[^1] or committed dose equivalent[^2] to an individual organ
or tissue that warrants protective action following a release of
radionuclides.\" The 1998 FDA document replaced the Preventative and
Emergency PAGs with one set of PAGs for the ingestion pathway. The PAGs
established in the 1998 FDA document are 5 mSv for committed effective
dose equivalent or 50 mSv committed dose equivalent to an individual
tissue or organ, whichever is more limiting (i.e., the most limiting PAG
results in the lowest level of radionuclide activity concentration in
food).

For 5 mSv committed effective dose equivalent (the PAG adopted in the
new CPG), the associated lifetime total cancer mortality would be 2.25 x
10^-4^ or approximately 1 in 4400. For comparison, the estimate of the
normal lifetime total cancer mortality in the United States for the
general population, not associated with additional radiation dose from
ingestion of food contaminated with radionuclides, is 0.19 or
approximately 1 in 5 (CIRRPC 1992). Thus, in a general population of
10,000 individuals, the number of cancer deaths over the lifetime of the
individuals would be 1990; if each received a committed effective dose
equivalent of 5 mSv, the number of cancer deaths over the lifetime of
the individuals could increase in theory by about 2, for a total of 1992
cancer deaths.

The numerical estimate of cancer deaths presented above for the
recommended PAG of 5 mSv was obtained by the practice of linear
extrapolation from the nominal risk estimate for lifetime total cancer
mortality for the general population at 100 mSv dose equivalent in the
whole body.[^3] Other methods of extrapolation to the low-dose region
could yield higher or lower numerical estimates of cancer deaths.
Studies of human populations exposed at low doses are inadequate to
demonstrate the actual magnitude of risk. There is scientific
uncertainty about cancer risk in the low-dose region below the range of
epidemiological observation, and the possibility of no risk cannot be
excluded (CIRRPC 1992).

The term \"PAG\" is used by FDA and other Federal and state agencies.
International organizations use the term "intervention level of dose"
(ICRP 1984b). The PAGs established in the 1998 FDA document and adopted
in this supporting document are the same as the intervention levels of
dose used by international organizations. The 1998 FDA guidance and this
supporting document retain use of the term "PAG\" for consistency with
other U.S. Federal and state agencies.

# III. FDA's Guidance Levels for Radionuclide Activity Concentrations in Food Established in 1986

Following the Chernobyl nuclear accident in 1986, FDA that same year
issued CPG Sec. 560.750 Radionuclides in Imported Foods -- Levels of
Concern (CPG 7119.14) which established guidance levels referred to as
Levels of Concern (LOCs) for radionuclide activity concentration in food
offered for import.

The LOCs in CPG 7119.14 were derived from the Preventative PAGs
established in the 1982 FDA guidance document and were based on the
following assumptions: 1) the entire intake of food would be
contaminated, 2) Iodine-131 would be a major source of radiation dose
for only 60 days following the accident, and 3) Cesium-134 + Cesium-137
could be a major source of radiation dose for up to one year. The LOCs
provided such a large margin of safety that derivation of LOCs for other
radionuclides, judged to be of less health significance, was considered
unnecessary. The LOCs in CPG 7119.14, established in 1986, are given in
Table 1.

# IV. FDA's 1998 Guidance Levels for Radionuclide Activity Concentration in Food Adopted in the Draft CPG

The guidance levels for radionuclide activity concentration in food in
the draft CPG are referred to in the 1998 document as "Derived
Intervention Levels" or DILs. DILs are used by scientists
internationally to describe the radionuclide activity concentrations at
which introduction of protective measures should be considered. The term
DILs as used in the draft CPG replaces the term LOCs used in CPG 7119.14
and allows for consistency in scientific terminology between the draft
CPG and the internationally accepted scientific term. Efforts by
international organizations to develop DILs have been extensive.
Derivations have been based on consensus values for the intervention
levels of dose, called PAGs by FDA, and have been used to establish
guidance levels for radionuclides in foods within individual countries
and in international trade. In general, food with concentrations below
the DILs is permitted to move in international trade without
restriction. Food with concentrations at or above the DILs is not
normally permitted into international trade.[^4]

By definition, a DIL corresponds to the radionuclide activity
concentration in food present throughout the relevant period of time
that, in the absence of any intervention, could lead to an individual
receiving a radiation dose equal to the PAG. The equation given below is
the formula that the agency used for calculating recommended DILs.

DILs (Bq/kg) = [PAG (mSv)]{.underline}

f x FI (kg) x DC (mSv/Bq)

Where:

> DC = Dose Coefficient; the radiation dose received per unit of
> radionuclide activity ingested (mSv/Bq)
>
> f = Fraction of the food intake assumed to be contaminated
>
> FI = Food Intake; the quantity of food consumed in an appropriate
> period of time (kg)

Guidance levels or LOCs contained in CPG 7119.14 addressed only I-131,
Cs-134 and Cs-137 because these radionuclides were known at that time to
be the principal radionuclides that contribute to radiation dose by
ingestion following a nuclear reactor accident. Information gained
following the Chernobyl accident determined that Ru-103 and Ru-106 could
also contribute to radiation dose and, therefore, these radionuclides
were included in the 1998 FDA document. In addition, other radionuclides
were included in the 1998 FDA document to address other radiological
emergencies where there is a possibility of accidental radioactive
contamination of food. This approach provides the flexibility necessary
to respond to special circumstances that may be unique to a particular
accident. The types of accidents and the principle radionuclides for
which DILs were developed are:

-   Nuclear reactors (I-131; Cs-134 + Cs-137; Ru-103 + Ru-106)

-   Nuclear fuel processing plants (St-90; Cs-137; Pu-238 + Pu-239 +
    Am-241)

-   Nuclear waste storage facilities (Sr-90; Cs-137; Pu-238 + Pu-239 +
    Am-241)

-   Nuclear weapons (i.e., dispersal of nuclear weapon material without
    nuclear detonation) (Pu-239), and

-   Radioisotope thermoelectric generators and radioisotope heater units
    used in space vehicles (Pu-238).

The DILs are for radionuclides expected to deliver the major portion of
the radiation dose from ingestion during the first year following an
accidental episode of radiological food contamination. If there is
concern that food will continue to be significantly contaminated beyond
the first year, the long-term circumstances need to be evaluated to
determine whether the recommended DILs would be appropriate or if other
guidance is more applicable.

Detailed information on derivation of DILs is presented in the appendix.
The DILs are based upon calculations for nine radionuclides expected to
be the predominant contributors to radiation dose through ingestion
(Sr-90, I-131, Cs-134, Cs-137, Ru-103, Ru-106, Pu-238, Pu-239, and
Am-241). For each radionuclide, DILs were calculated for six age groups
using PAGs, dose coefficients relevant to each radionuclide and age
group, and dietary intakes relevant to each age group. The age groups
include 3 months, 1 year, 5 years, 10 years, 15 years and adult (\>17
years). The dose coefficients were adopted by FDA from the International
Commission on Radiological Protection Publication 56 (ICRP 1989). The
dietary intakes were derived from a 1984 EPA report which presented
average daily food intake by age and gender (EPA 1984a, EPA 1984b).

The nine radionuclides listed above comprise five radionuclide groups,
each having common characteristics. The five groups are: Strontium-90;
Iodine-131; Cesium-134 + Cesium-137; Ruthenium-103 + Ruthenium-106; and
Plutonium-238 + Plutonium-239 + Americium-241. An accident could involve
more than one of the five groups. A single DIL for each radionuclide
group was chosen based on the most limiting PAG and age group for the
radionuclide group (i.e., the most limiting PAG and age group result in
the lowest DIL). These five DILs are the ones incorporated into the new
CPG.

The calculations underlying the DILs are based on the entire diet for
each age group, not for individual foods or food groups. Unlike the
previous LOCs that assumed 100 percent radionuclide contamination of the
diet, DILs assume ten percent radionuclide contamination of the diet
which is then multiplied by a factor of three. Use of ten percent of the
dietary intake as the portion contaminated is consistent with
recommendations made by a group of experts to the Commission of the
European Communities (CEC 1986b) and by the Nuclear Energy Agency (NEA)
of the Organization for Economic Cooperation and Development (NEA 1989).
FDA applied an additional factor of three to account for limited
sub-populations that might be more dependent on specific food supplies.
Therefore, a value of thirty percent is the fraction of food intake that
FDA presumed to be contaminated. For infants, (i.e., the 3-months and
1-year age groups) DILs were calculated assuming 100 percent
radionuclide contamination of the infant diet.

With one exception (LOCs for I-131 in non-infant food), guidance levels
or DILs for radionuclides established in the 1998 FDA document that FDA
has adopted in the draft CPG are higher than guidance levels or LOCs for
those same radionuclides contained in the CPG 7119.14. In deriving
guidance levels or DILs contained in the 1998 FDA document, FDA employed
updated international consensus values for intervention levels of dose
(called PAGs by FDA) as well as updated dose coefficients and food
intake estimates. In addition, information gained by FDA and others
following the Chernobyl accident determined that the amount of food
affected by an accident would be significantly lower than the level
originally estimated. For this reason, DILs contained in the 1998 FDA
document assume thirty percent of the dietary intake would be
contaminated after a nuclear accident, compared to the 100 percent
assumption of contamination employed in deriving LOCs. FDA's decision to
reduce the assumption for dietary intake contamination from 100 percent
to thirty percent is the main reason that the guidance levels
established in the 1998 FDA document and adopted in the draft CPG are
higher than the guidance levels contained in CPG 7119.14.

The 1998 FDA document established guidance levels only for food
accidentally contaminated with radionuclides in domestic interstate
commerce. In the draft CPG, FDA has adopted those same guidance levels
for food either accidentally or intentionally contaminated with
radionuclides, regardless of whether that food is in domestic interstate
commerce or offered for import. FDA has taken this action because
radionuclides that could be implicated in an event involving the
accidental contamination of food could also be implicated in an event
involving the intentional contamination of food. The radionuclides
addressed in the 1998 FDA document are widely used and available.
Furthermore, an incident resulting in release of radionuclides from one
of the nuclear facilities addressed in the 1998 FDA document would
likely result in the release of the same radionuclides regardless of
whether the cause of the release was accidental or intentional. FDA has
therefore concluded that the assumptions used in establishing the DILs
in the 1998 FDA document and adopted in the draft CPG are appropriate
for both accidental as well as intentional radionuclide contamination of
food.

The DILs established in the 1998 FDA document and contained in the draft
CPG for food offered for import and food in domestic interstate commerce
are given in Table 2.

## TABLE 1

LEVELS OF CONCERN (LOCS) FOR RADIONUCLIDE ACTIVITY CONCENTRATION IN
IMPORTED FOOD FROM CPG SEC. 560.750 RADIONUCLIDES IN IMPORTED FOODS --
LEVELS OF CONCERN (CPG 7119.14) WHICH HAVE BEEN SUPERCEDED BY DERIVED
INTERVENTION LEVELS (DILS) IN CPG SEC. \<ADD SECTION NUMBER\> GUIDANCE
LEVELS FOR RADIONUCLIDES IN DOMESTIC AND IMPORTED FOODS (CPG \<ADD CPG
NUMBER\>).^(a)^

  ----------------------------------- -----------------------------------
  Radionuclide Group                  LOCs (Bq/kg)

  A. Infant Food                      

  Iodine-131                          55

  Cesium-134 + Cesium-137             370

  B. Other Food                       

  Iodine-131                          300

  Cesium-134 + Cesium-137             370
  ----------------------------------- -----------------------------------

^(a)^For consistency with current recommendations, LOCs in this table
are expressed in Bq/kg. In CPG 7119.14, LOCs were expressed in pCi/kg.

## TABLE 2

DERIVED INTERVENTION LEVELS (DILS) IN THE NEW CPG FOR FOOD IN DOMESTIC
COMMERCE AND FOOD OFFERED FOR IMPORT^(a,b).^ THESE VALUES, WHICH ARE
INCLUDED IN CPG SEC. \<ADD SECTION NUMBER\> GUIDANCE LEVELS FOR
RADIONUCLIDES IN DOMESTIC AND IMPORTED FOODS (CPG \<ADD CPG NUMBER\>),
SUPERCEDE LEVELS OF CONCERN (LOCS) IN CPG SEC. 560.750 RADIONUCLIDES IN
IMPORTED FOODS -- LEVELS OF CONCERN (CPG 7119.14).

+-------------------------------------+--------------------------------+
| Radionuclide Group                  | DIL (Bq/kg)                    |
+-------------------------------------+--------------------------------+
| Strontium-90                        | 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
sum must be less than one. C~3~ and C~6~ are the concentrations, at the
time of measurement, for Ruthenium-103 and Ruthenium-106, respectively.

**Appendix -- Derivation of Recommended Derived Intervention Levels**

The Derived Intervention Level (DIL) for a specific radionuclide is
calculated as follows:

DILs (Bq/kg) = [PAG (mSv)]{.underline}

f x FI (kg) x DC (mSv/Bq)

Where:

> DC = Dose Coefficient; the radiation dose received per unit of
> radionuclide activity ingested (mSv/Bq)
>
> f = Fraction of the food intake assumed to be contaminated
>
> FI = Food Intake; the quantity of food consumed in an appropriate
> period of time (kg)

The Protective Action Guides (PAGs)used are 5 mSv committed effective
dose equivalent, or 50 mSv committed dose equivalent to individual
tissues and organs, whichever is more limiting.

Dose coefficients (DCs) are given in Table 3 and food intakes are given
in Tables D-2 and D-3. The fraction of food intake assumed to be
contaminated (f) equals 0.3, except for I-131 in infant diets where f
equals 1.0.

**(a) Radionuclides**

Based upon data on radionuclides in human food following the Chernobyl
accident, DILs for I-131, Cs-134, Cs-137, Ru-103 and Ru-106 would apply
following incidents involving nuclear reactors. For incidents at nuclear
fuel reprocessing facilities and nuclear waste storage facilities, DILs
for Sr-90, Cs-137, Pu-239, and Am-241 would apply. For nuclear weapons
incidents and incidents involving radioisotope thermal generators (RTGs)
and radioisotope heater units (RHUs) used in space vehicles, DILs for
Pu-239 and Pu-238, respectively, would apply. The selection of these
radionuclides as the major contributors to radiation dose through
ingestion is consistent with recommendations on DILs published by NEA,
WHO, CODEX, and CEC (NEA 1989, WHO 1988, CODEX 1989, CEC 1989a, IAEA
1994).

**(b) Age Groups and Dose Coefficients (DCs)**

> The general population was divided into six age groups ranging from
> infants to adults and corresponding to the age groups in ICRP
> Publication 56 (ICRP 1989) for which ICRP has published DCs. The age
> groups are 3 months, 1 year, 5 years, 10 years, 15 years, and adult.
> The radionuclides, age groups and dose coefficients used in the
> calculations are presented in Table 3.

**(c) Food Intake**

Food intake included all dietary components including tap water used for
drinking, and is the overall quantity consumed in one year, with
exceptions in the period of time for I-131 (T~1/2~ = 8.04 days) and
Ru-103 (T~1/2~ = 39.3 days). For these radionuclides, the quantities
consumed were for a 60-day period and a 280-day period, respectively,
due to the more rapid decay of these radionuclides. The intake periods
for I-131 and Ru-103 are the nearest whole number of days for decay of
these radionuclides to less than 1% of the initial activities.

Dietary intakes were derived from a 1984 EPA report which presented
average daily food intake by age and gender (EPA 1984a, EPA 1984b). The
EPA intakes were based on data from the 1977-1978 Nationwide Food
Consumption Survey published by the U. S. Department of Agriculture
(USDA 1982, USDA 1983). The age groups and annual dietary intakes for
various food classes and the total, calculated from data in the EPA
report, are given in Table 4. The dietary intakes derived for the ICRP
age groups for which DCs are available, using the results in Table 4,
are presented in Table 5.

**(d) Fractions of Food Intake Assumed to be Contaminated**

For food consumed by most members of the general public, ten percent of
the dietary intakes was assumed to be contaminated. This assumption
recognizes the ready availability of uncontaminated food from unaffected
areas of the United States or through importation from other countries,
and also that many factors could reduce or eliminate contamination of
local food by the time it reaches the market.

Use of ten percent of the dietary intake as the portion contaminated was
consistent with recommendations made by a Group of Experts to the
Commission of the European Communities (CEC 1986a) and by the Nuclear
Energy Agency (NEA) of the Organization for Economic Cooperation and
Development (NEA 1989). The NEA noted that modification of this value
would be appropriate if justified by detailed local findings.

> FDA applied an additional factor of three to account for the fact that
> sub-populations might be more dependent on local food supplies.
> Therefore, during the immediate period after a nuclear accident, a
> value of 0.3 (i.e., thirty percent) is the fraction of food intake
> presumed to be contaminated. If, subsequently, there is convincing
> local information that the actual fraction of food intake that is
> contaminated (f) is considerably higher or lower, there will be
> adequate time to determine whether to adjust the value of f (and
> therefore adjust the values of the DILs) for the affected area.
>
> For infants, (i.e., the 3-months and 1-year age groups) the diet
> consists of a high percentage of milk and the entire milk intake of
> some infants over a short period of time might come from supplies
> directly impacted by an accident. Therefore, f was set equal to 1.0
> (100%) for the infant diet.

**(e) Selection of Recommended Derived Intervention Levels**

DILs are presented in Table 6 for Sr-90, I-131, Cs-134, Cs-137, Ru-103,
Ru-106, Pu-238, Pu-239, and Am-241 for six population age groups and
applicable PAGs. Two criteria were used in selecting a single DIL for
each radionuclide for inclusion in the new CPG.

First, the most limiting DIL for either of the applicable PAGs was
selected for each of the nine radionuclides. These DILs are presented in
Table 7 for each of the six age groups. In addition, the average DIL is
presented for the radionuclide group Pu + Am, composed of Pu-238,
Pu-239, and Am-241*,* and the radionuclide group Cs, composed of
Cs-134 + Cs-137. The three radionuclides in the Pu + Am group deposit on
the bone surface and are alpha-particle emitters. The radionuclides in
the Cs group are deposited throughout the body and are beta-particle and
gamma-ray emitters. The average values are used for these groups because
the calculated DILs for radionuclides in each group are similar.

The radionuclides Ru-103 and Ru-106 are chemically identical, are
deposited throughout the body, and are beta-particle and gamma-ray
emitters. However, their widely differing half lives (i.e., 39.3 days
and 373 days, respectively) result in markedly differing individual DILs
which do not permit simple averaging. Instead, the concentrations of
Ru-103 (C3) and Ru-106 (C6) are divided by their respective DILs and are
then summed. The DIL for the Ruthenium group is set at less than one.

Therefore, C3 + C6 \< 1.0 (equation 1)

DIL3 DIL6

This assures that the sum of the separate radiation dose contributions
from the Ru-103 and Ru-106 concentrations will be less than that
contemplated by the Protective Action Guide during the first year after
an accident.

Second, there are dietary components which are common to all six age
groups. A principal example is fresh milk, for which the consumer of
particular supplies cannot be identified in advance. Therefore, the most
limiting DIL for all age groups in Table 7, for each radionuclide or
radionuclide group, was selected and is applicable to all components of
the diet.

These DILs are presented in Table 8 and were rounded to two significant
figures (one significant figure for the Pu + Am group). These are the
DILs adopted in the new CPG. The DILs in Table 8 apply independently to
each radionuclide or radionuclide group, because they apply to different
types of incidents, or in the case of a nuclear reactor incident, to
different limiting age groups. However, the DILs for Ru-103 and Ru-106
are used in equation 1 to evaluate that criterion for the radionuclide
group Ru-103 + Ru-106. The DILs in Table 8 are given in Table 2 in the
main text.

**TABLE 3**

DOSE COEFFICIENTS (mSv/Bq)^(a)^

  ----------------- --------- --------- --------- --------- --------- ---------
                    Age Group                                         

  Radionuclide      3 month   1 year    5 years   10 years  15 years  Adult

  Sr-90 bone        1.0E-03   7.4E-04   3.9E-04   5.5E-04   1.2E-03   3.8E-04
  surface                                                             

  Sr-90             1.3E-04   9.1E-05   4.1E-05   4.3E-05   6.7E-05   3.5E-05

  I-131 thyroid     3.7E-03   3.6E-03   2.1E-03   1.1E-03   6.9E-04   4.4E-04

  I-131             1.1E-04   1.1E-04   6.3E-05   3.2E-05   2.1E-05   1.3E-05

  Cs-134            2.5E-05   1.5E-05   1.3E-05   1.4E-05   2.0E-05   1.9E-05

  Cs-137            2.0E-05   1.1E-05   9.0E-06   9.8E-06   1.4E-05   1.3E-05

  Ru-103            7.7E-06   5.1E-06   2.7E-06   1.7E-06   1.0E-06   8.1E-07

  Ru-106            8.9E-05   5.3E-05   2.7E-05   1.6E-05   9.2E-06   7.5E-06

  Pu-238 bone       1.6E-01   1.6E-02   1.5E-02   1.5E-02   1.6E-02   1.7E-02
  surface                                                             

  Pu-238            1.3E-02   1.2E-03   1.0E-03   8.8E-04   8.7E-04   8.8E-04

  Pu-239 bone       1.8E-01   1.8E-02   1.8E-02   1.7E-02   1.9E-02   1.8E-02
  surface                                                             

  Pu-239            1.4E-02   1.4E-03   1.1E-03   1.0E-03   9.8E-04   9.8E-04

  Am-241 bone       2.0E-01   1.9E-02   1.9E-02   1.9E-02   2.1E-02   2.0E-02
  surface                                                             

  Am-241            1.2E-02   1.2E-03   1.0E-03   9.0E-04   9.1E-04   8.9E-04
  ----------------- --------- --------- --------- --------- --------- ---------

^(a)^Dose coefficients are from ICRP Publication 56 (ICRP 1989). The
committed effective dose equivalents or committed dose equivalents are
computed to age 70 years.

**TABLE 4**

ANNUAL DIETARY INTAKES (kg/y)^(a,b)^

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<col style="width: 8%" />
<col style="width: 7%" />
<col style="width: 7%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 8%" />
<col style="width: 11%" />
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<tbody>
<tr class="odd">
<td></td>
<td colspan="10">Age Group</td>
</tr>
<tr class="even">
<td>Food Class</td>
<td>&lt; 1</td>
<td>1-4</td>
<td>5-9</td>
<td>10-14</td>
<td>15-19</td>
<td>20-24</td>
<td>25-29</td>
<td>30-39</td>
<td>40-59</td>
<td>60 &amp; up</td>
</tr>
<tr class="odd">
<td><p>Dairy</p>
<p>(fresh milk)</p></td>
<td><p>208</p>
<p>(99.3)</p></td>
<td><p>153</p>
<p>(123)</p></td>
<td><p>180</p>
<p>(163)</p></td>
<td><p>186</p>
<p>(167)</p></td>
<td><p>167</p>
<p>(148)</p></td>
<td><p>112</p>
<p>(96.5)</p></td>
<td><p>98.2</p>
<p>(79.4)</p></td>
<td><p>86.4</p>
<p>(66.8)</p></td>
<td><p>80.8</p>
<p>(61.7)</p></td>
<td><p>90.6</p>
<p>(70.2)</p></td>
</tr>
<tr class="even">
<td>Egg</td>
<td>1.8</td>
<td>7.2</td>
<td>6.2</td>
<td>7.0</td>
<td>9.1</td>
<td>10.3</td>
<td>10.2</td>
<td>11.0</td>
<td>11.4</td>
<td>10.5</td>
</tr>
<tr class="odd">
<td>Meat</td>
<td>16.5</td>
<td>33.7</td>
<td>46.9</td>
<td>58.4</td>
<td>69.2</td>
<td>71.2</td>
<td>72.6</td>
<td>73.4</td>
<td>70.7</td>
<td>56.3</td>
</tr>
<tr class="even">
<td>Fish</td>
<td>0.3</td>
<td>2.5</td>
<td>4.0</td>
<td>4.6</td>
<td>6.1</td>
<td>6.8</td>
<td>7.6</td>
<td>7.1</td>
<td>8.0</td>
<td>6.3</td>
</tr>
<tr class="odd">
<td>Produce</td>
<td>56.6</td>
<td>59.9</td>
<td>82.3</td>
<td>96.0</td>
<td>97.1</td>
<td>91.4</td>
<td>99.1</td>
<td>102</td>
<td>115</td>
<td>121</td>
</tr>
<tr class="even">
<td>Grain</td>
<td>20.4</td>
<td>57.6</td>
<td>79.0</td>
<td>90.6</td>
<td>89.4</td>
<td>77.3</td>
<td>78.4</td>
<td>73.7</td>
<td>70.2</td>
<td>67.1</td>
</tr>
<tr class="odd">
<td><p>Beverage</p>
<p>(tap water)</p></td>
<td><p>112</p>
<p>(62.3)</p></td>
<td><p>271</p>
<p>(159)</p></td>
<td><p>314</p>
<p>(190)</p></td>
<td><p>374</p>
<p>(226)</p></td>
<td><p>453</p>
<p>(243)</p></td>
<td><p>542</p>
<p>(240)</p></td>
<td><p>559</p>
<p>(226)</p></td>
<td><p>599</p>
<p>(232)</p></td>
<td><p>632</p>
<p>(268)</p></td>
<td>565</td>
</tr>
<tr class="even">
<td>Misc</td>
<td>2.0</td>
<td>9.3</td>
<td>13.3</td>
<td>14.8</td>
<td>13.9</td>
<td>10.9</td>
<td>11.9</td>
<td>12.5</td>
<td>13.3</td>
<td>13.0</td>
</tr>
<tr class="odd">
<td>TOTAL ANNUAL INTAKE, (kg/y)</td>
<td>418</td>
<td>594</td>
<td>726</td>
<td>832</td>
<td>905</td>
<td>922</td>
<td>937</td>
<td>965</td>
<td>1001</td>
<td>930</td>
</tr>
</tbody>
</table>

^(a)^Computed from daily intake values in grams per day provided in (EPA
1984b). The total annual intakes are rounded to nearest 1 kg/y.

^(b)^Fresh milk is included in the dairy entry, and tap water used for
drinking is included in the beverage entry. The total annual intakes
(kg/y) for fresh milk and tap water are also given separately in
parentheses.

**TABLE 5**

DIETARY INTAKES FOR ICRP AGE GROUPS

+-----------------+-----------------+-----------------+-----------------+
| ICRP Age Group  | Annual          | 280-Day Intake  | 60-Day Intake   |
|                 | Intake^(a)^     |                 |                 |
|                 |                 | Ru-103          | I-131           |
|                 | (kg)            |                 |                 |
|                 |                 | (kg)            | (kg)            |
+-----------------+-----------------+-----------------+-----------------+
| 3 months        | 418             | 320             | 69              |
+-----------------+-----------------+-----------------+-----------------+
| 1 year          | 506             | 387             | 83              |
+-----------------+-----------------+-----------------+-----------------+
| 5 years         | 660             | 506             | 109             |
+-----------------+-----------------+-----------------+-----------------+
| 10 years        | 779             | 597             | 128             |
+-----------------+-----------------+-----------------+-----------------+
| 15 years        | 869             | 666             | 143             |
+-----------------+-----------------+-----------------+-----------------+
| Adult           | 943             | 723             | 155             |
+-----------------+-----------------+-----------------+-----------------+

^(a)^The annual dietary intake for the ICRP age groups was obtained by
assigning or averaging the appropriate annual dietary intakes given in
Table 4 for the EPA age groups, as follows:

3 months: used \<1

1 year: average of \<1 and 1-4

5 years: average of 1-4 and 5-9

10 years: average of 5-9 and 10-14

15 years: average of 10-14 and 15-19

Adult: average of 15-19, 20-24, 25-29, 30-39, 40-59 and 60 and up

**TABLE 6**

PAGs AND DERIVED INTERVENTION LEVELS^(a)^

(individual radionuclides, by age groups)

  ----------------- ------- -------------- ------ ------- -------- ------- -------
                    PAG     Devived                                        
                            Intervention                                   
                            Levels (Bq/kg)                                 

  Radionuclide      (mSv)   3 month        1 yr   5 years 10 years 15      Adult
                                                                   years   

  Sr-90 bone        50      400            445    648     389      160     465
  surface^(b)^                                                             

  Sr-90             5       308            362    616     497      286     505

  I-131 thyroid     50      196            167    722     1200     1690    2420

  I-131             5       659            548    2410    4110     5540    8180

  Cs-134            5       1600           2190   1940    1530     958     930

  Cs-137            5       2000           2990   2810    2180     1370    1360

  Ru-103            5       6770           8410   12200   16400    25000   28400

  Ru-106            5       449            621    935     1340     2080    2360

  Pu-238 bone       50      2.5            21     17      14       12      10
  surface                                                                  

  Pu-238            5       3.1            27     25      24       22      20

  Pu-239 bone       50      2.2            18     14      13       10      9.8
  surface                                                                  

  Pu-239            5       2.9            24     23      21       20      18

  Am-241 bone       50      2.0            17     13      11       9.1     8.8
  surface                                                                  

  Am-241            5       3.3            27     25      24       21      20
  ----------------- ------- -------------- ------ ------- -------- ------- -------

^(a)^Derived Intervention Levels were computed using dose coefficients
from Table 3, dietary intakes from Table 5, and "f" as given below:

0.3 (except for I-131 in infant diets, i.e., the 3-month and 1-year age
groups)

1.0 (I-131 in infant diets)

^(b)^The observed trend in Derived Intervention Levels for Sr-90 as a
function of age, i.e., minimum values at 15 years, results primarily
from mass of exchangeable strontium in bone as a function of age (Legget
et al. 1982).

**TABLE 7**

DERIVED INTERVENTION LEVELS (Bq/kg)

(individual radionuclides, by age group, most limiting of either PAG)

  --------------- --------- --------- --------- --------- --------- ---------
  Radionuclide    3 months  1 year    5 years   10 years  15 years  Adult

  Sr-90           308       362       616       389       160       465

  I-131           196       167       722       1200      1690      2420

  Cs-134          1600      2190      1940      1530      958       930

  Cs-137          2000      2990      2810      2180      1370      1360

  Cs-group^(a)^   1800      2590      2380      1880      1160      1150

  Ru-103          6770      8410      12200     16400     25000     28400

  Ru-106          449       621       935       1340      2080      2360

  Pu-238          2.5       21        17        14        12        10

  Pu-239          2.2       18        14        13        10        9.8

  Am-241          2.0       17        13        11        9.1       8.8

  Pu + Am         2.2       19        15        13        9.6       9.3
  group^(b)^                                                        
  --------------- --------- --------- --------- --------- --------- ---------

^(a)^Computed as: (DIL for Cs-134 + DIL for Cs-137)/2

^(b)^Computed as: (DIL for Pu-238 + DIL for Pu-239 + DIL for Am-241)/3

**TABLE 8**

DERIVED INTERVENTION LEVELS (Bq/kg)

(radionuclide groups, most limiting of all diets)

  ----------------------------------- -----------------------------------
  Radionuclide Group                  Derived Intervention Levels

  Sr-90                               160 (15 years)

  I-131                               170 (1 year)

  Cs group                            1200 (adult)

  Ru-103^(a)^                         6800 (3 months)

  Ru-106^(a)^                         450 (3 months)

  Pu + Am group                       2 (3 months)
  ----------------------------------- -----------------------------------

^(a)^Due to large differences in DILs for Ru-103 and Ru-106, the
individual concentrations of Ru-103 and Ru-106, the individual
concentrations of Ru-103 and Ru-106 are divided by their respective DILs
and summed. The DIL for the Ruthenium group is set at less than one.

**VI. References**

(CEC 1986a) Commission of the European Communities. Derived Reference
Levels as a Basis for the Control of Foodstuffs Following a Nuclear
Accident. A recommendation from the group of experts set up under
Article 31 of the Euratom Treaty. Brussels; 1986.

(CEC 1986b) Commission of the European Communities. Council Regulation
(EEC) No. 1707/86 of 30 May 1986, on the conditions governing imports of
agricultural products originating in third countries following the
accident at the Chernobyl nuclear power station. Official Journal of the
European Communities L146:88-90; 1986.

(CEC 1989a) Commission of the European Communities. Council Regulation
(Euratom) No. 2218/89 of 18 July 1989, amending Regulation (Euratum) No.
3594/87, laying down maximum permitted levels of radioactive
contamination of foodstuffs following a nuclear accident or any other
case of radiological emergency. Official Journal of the European
Communities L211:1; 1989.

(CIRRCP 1992) Committee on Interagency Radiation Research and Policy
Coordination. Use of BEIR IV and UNSCEAR 1988 in Radiation Risk
Assessment, Lifetime Total Cancer Mortality Rate Estimates at Low Doses
and Low Dose Rates for Low-LET Radiation. Science Panel Report No. 9;
CIRRPC, Washington, D.C.; 1992.

(CODEX 1989) Committee on Interagency Radiation Research and Policy
Coordination. Use of BEIR IV and UNSCEAR 1988 in Radiation Risk
Assessment, Lifetime Total Cancer Mortality Rate Estimates at Low Doses
and Low Dose Rates for Low-LET Radiation. Science Panel Report No. 9;
CIRRPC, Washington, D.C.; 1992.

(EPA 1987) Environmental Protection Agency. Radiation Protection
Guidance to Federal Agencies for Occupational Exposure. [Federal
Register]{.underline} 52:2822-2834; 1987.

(EPA 1984a) Environmental Protection Agency. An estimation of the Daily
Food Intake Based on Data from the 1977-1978 USDA Nationwide Food
Consumption Survey. Office of Radiation Programs. Washington D.C.: EPA
520/1-84-015; 1984.

(EPA 1984b) Environmental Protection Agency. An estimation of the Daily
Average Food Intake by Age and Sex for Use in Assessing the Radionuclide
Intake of Individuals in the General Population. Office of Radiation
Programs. Washington D.C.: EPA 520/1-84-021; 1984.

(FDA 1982) Food and Drug Administration. Accidental Radioactive
Contamination of Human Food and Animal Feeds: Recommendations for State
and Local Agencies. [Federal Register]{.underline} 47:47073-47083; 1982.

(FDA 1986) Food and Drug Administration. Radionuclides in Foods- Derived
Intervention Levels. FDA Compliance Policy Guide 7119.14, Section
560.750; 1986.

(FDA 1998) Food and Drug Administration. Accidental Radioactive
Contamination of Human Food and Animal Feeds: Recommendations for State
and Local Agencies. [Federal Register]{.underline} 63:43402-43403; 1998.

(FRC 1960) Federal Radiation Council. Background Material for the
Development of Radiation Protection Standards. Washington, D.C.: FRC;
Report No. 1; 1960.

(FRC 1961) Federal Radiation Council. Background Material for the
Development of Radiation Protection Standards. Washington, D.C.: FRC;
Report No. 2; 1961.

(IAEA 1994) International Atomic Energy Agency. International Basic
Safety Standards for Protection against Ionizing Radiation and for the
Safety of Radiation Sources, Interim Edition. Vienna; Safety Series No.
115-I; 1994.

(ICRP 1977) International Commission on Radiological Protection.
Recommendations of the International Commission on Radiological
Protection. Oxford: Pergamon Press; ICRP Publication 26: Ann. ICRP 1(3);
1977.

(ICRP 1984a) International Commission on Radiological Protection. A
Compilation of the Major Concepts and Quantities in Use by ICRP. Oxford:
Pergamon Press; ICRP Publication 42: Ann. ICRP 14(4); 1984.

(ICRP 1984b) International Commission on Radiological Protection.
Protection of the Public in the Event of Major Radiation Accidents:
Principles for Planning. Oxford: Pergamon Press; ICRP Publication 40;
Ann. ICRP 14(2); 1984.

(ICRP 1989) International Commission on Radiological Protection.
Age-dependent Doses to Members of the Public from Intake of
Radionuclides. Oxford: Pergamon Press; ICRP Publication 56, Part 1; Ann.
ICRP 20(2); 1989.

(Legget et al. 1982) Legget, R.W., Eckerman, K.F., Willaims, L.R.
Strontium-90 in Bone: A Case Study in Age-Dependent Dosimetric Modeling.
[Health Physics]{.underline} Vol. 43, No. 3, pp. 307-322; 1982.

(NEA 1989) Nuclear Energy Agency. Nuclear Accidents: Intervention Levels
for Protection of the Public. Paris: Organization for Economic
Co-operation and Development; 1989.

(USDA 1982) U.S. Department of Agriculture. Foods Commonly Eaten by
Individuals: Amount Per Day and Per Eating Occasion. Washngton D.C.:
Human Nutrition Service; Home Economics Research Report No. 44; March
1982.

(USDA 1983) U.S. Department of Agriculture. Food Intakes: Individuals in
49 States, Year 1977-1978. Washington D.C.: Human Nutrition Service;
National Food Consumption Survey 1977-78; Report No. I-1; August 1983.

(WHO 1988) World Health Organization. Derived Intervention Levels for
Radionuclides in Foods -- Guidelines for Application after Widespread
Radioactive Contamination Resulting from a Major Accident. Geneva:
WHO;1988.

[^1]: Committed effective dose equivalent -- Committed dose equivalents
    to individual organs or tissues, multiplied by weighting factors,
    then summed. In this document, committed effective dose is always
    computed to age 70 years (ICRP 1984a).

[^2]: Committed dose equivalent -- The dose equivalent accruing in an
    organ or tissue up to a specified number of years after the intake
    of a radionuclide into the body. In this document, committed dose
    equivalent is always computed to age 70 years (ICRP 1984a).

[^3]: The current nominal estimate for the general population for
    lifetime total cancer mortality for low-LET (linear energy transfer)
    ionizing radiation, delivered at low doses and low dose rates, is
    4.5 x 10^-3^ for a reference dose equivalent in the whole body of
    100 mSv (CIRRPC 1992).

[^4]: The DILs adopted in the 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.