[Federal Register Volume 69, Number 244 (Tuesday, December 21, 2004)]
[Rules and Regulations]
[Pages 76401-76404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-27868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 1993F-0357]


Irradiation in the Production, Processing, and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of a source of fast 
(high energy) neutrons to inspect containers that may contain food. 
This action is in response to a petition filed by Science Applications 
International Corp. (SAIC).

DATES: This rule is effective December 21, 2004. Submit written or 
electronic objections and requests for a hearing by January 20, 2005. 
See section VII of this document for information on the filing of 
objections.

ADDRESSES: You may submit written objections and requests for a 
hearing, identified by Docket No. 1993F-0357, by any of the following 
methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Agency Web site: http://www.fda.gov/dockets/ecomments. 
Follow the instructions for submitting comments on the agency Web site.
     E-mail: [email protected]. Include Docket No. 1993F-
0357 in the subject line of your e-mail message.
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All objections received will be 
posted without change to http://www.fda.gov/ohrms/dockets/default.htm, 
including any personal information provided. For detailed instructions 
on submitting objections, see the ``Objections'' heading of the 
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Celeste Johnston, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1282.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of November 18, 1993 
(58 FR 60860), FDA announced that a food additive petition (FAP 3M4399) 
had been filed by Science Applications International Corp., 2950 
Patrick Henry Dr., Santa Clara, CA 95054. The petition proposed that 
the food additive regulations in Sec.  179.21 Sources of radiation used 
for inspection of food, for inspection of packaged food, and for 
controlling food processing (21 CFR 179.21) be amended to provide for 
the safe use of a source of fast (high energy) neutrons to inspect 
cargo containers that may contain food. In a letter dated January 9, 
1998, FDA was informed by Ancore Corp. that they were previously the 
division of SAIC responsible for this petition but had been reorganized 
into a separate company. The letter explained that as part of this 
reorganization, the rights to FAP 3M4399 had been transferred from SAIC 
to Ancore Corp. (same address as SAIC).
    When the petition was filed on November 18, 1993, it contained an 
environmental assessment (EA). In the notice of filing for this 
petition, the agency announced that it was placing the EA submitted 
with this petition on display at the Division of Dockets Management for 
public review and comment. No comments on the EA were received. Based 
on the original EA, FDA prepared a finding of no significant impact to 
the environment dated May 31, 1994. On July 29, 1997, FDA published 
revised regulations under part 25 (21 CFR part 25), which became 
effective on August 28, 1997. On May 12, 2003, the petitioner submitted 
a claim of categorical exclusion under the new Sec.  25.32(j), in 
accordance with the procedures in Sec.  25.15(a) and (d). Because the 
environmental record for the FAP was outdated, the agency reviewed the 
claim of categorical exclusion under Sec.  25.32(j) for this final rule 
and found it to be warranted.

II. Evaluation of Safety

    A source of radiation used for the purpose of inspection of foods 
meets the definition of a food additive under

[[Page 76402]]

section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 321(s)). Under section 409(c)(3)(A) of the act (21 U.S.C. 
348(c)(3)(A)), a food additive cannot be approved for a particular use 
unless a fair evaluation of the data available to FDA establishes that 
the additive is ``safe'' for that use. FDA's food additive regulations 
in 21 CFR 170.3(i) define safe as ``a reasonable certainty in the minds 
of competent scientists that the substance is not harmful under the 
intended conditions of use.''

III. Evaluation of the Safety of the Petitioned Use of a Source of 
Radiation

A. Background on Pulsed Fast Neutron Analysis

    Neutron-based techniques can be used to screen large cargo 
containers for contraband such as explosives, chemical warfare agents, 
and illegal drugs. Unlike conventional systems based on x rays or gamma 
rays, surveillance systems employing neutrons are able to provide more 
specific information on a cargo's elemental composition. When a neutron 
beam is directed at a target, the neutrons interact with target nuclei 
by either scattering or by nuclear reactions such as neutron capture by 
the target nuclei. Some captured neutrons result in the production of 
unstable isotopes that decay by emitting characteristic gamma rays, 
which can be detected and used to identify emitting chemical elements. 
Using gamma ray spectroscopy, information can be obtained on the 
concentration of chemical elements of the scanned object. Because the 
concentrations of certain elements in these types of illicit materials 
are characteristically different from other materials, such illicit 
materials can be detected. The present petition proposes the use of a 
pulsed fast neutron analysis system employing a beam of high energy 
neutrons at energies up to 9 million electron volts (MeV) to inspect 
large cargo containers and trucks that may contain food, provided that 
the maximum dose absorbed by the food does not exceed 0.01 gray (Gy). 
The scanning neutron beam operates in one of two modes, fast scan and 
directed search. Most containers would be exposed to a fast scan search 
only. During a fast scan, the beam impinges on any one position in the 
container for at most 1 second. Suspicious containers may be subjected 
to a directed search. A typical directed search would focus the beam on 
one position in the container for 10 seconds, but it is possible that 
it may be necessary to dwell on one location for up to 5 minutes.

B. Radiolysis Products

    One of the safety issues considered by FDA when it is evaluating a 
source of radiation used to inspect or treat food is the potential for 
formation of products generated in the food by radiation-induced 
chemical reactions (radiolysis products). The types and amounts of 
these products generated in the food depend on the chemical 
constituents of the food and on the conditions of irradiation. 
Radiation chemistry of components of food previously has been discussed 
in detail in the agency's final rule permitting the irradiation of meat 
(62 FR 64107, December 3, 1997). As stated in the meat irradiation 
final rule, most of the radiolysis products that are generated from 
food irradiation are also found in foods that have not been irradiated. 
Some of these compounds are also produced by heating foods, and, in the 
case of heating, are produced in amounts far greater than the trace 
amounts that result from irradiating foods.
    The amount of radiolysis products generated in food increases with 
increasing absorbed dose of radiation. FDA has previously established 
that gamma rays from radionuclides of cobalt-60 or cesium-137, high-
energy electrons up to 10 MeV, and x rays up to 5 MeV are safe for the 
treatment of different types of food at doses ranging from 0.3 kiloGray 
(kGy) to 30 kGy, depending on the type of food. Because the current 
petition proposes to limit the maximum absorbed dose to 0.01 Gy (a dose 
at least 30,000 times less than these approved uses), the amounts of 
radiolysis products generated in food from the petitioned source of 
radiation will be less than from these approved sources. Accordingly, 
FDA has concluded that the proposed use is safe in terms of exposure to 
potential radiolysis products.

C. Neutron-Induced Radioactivity

    Neutrons have a greater propensity to induce radioactivity in 
scanned materials than x rays and gamma rays of the same energy. To 
assess the induction of radioactivity in food by neutron irradiation 
from a cargo surveillance system, the petitioner submitted a 1992 
report (the Harwell Report) that was prepared by Harwell Laboratory of 
the United Kingdom's Atomic Energy Authority (Ref. 1) and a study that 
was performed by the petitioner (Ref. 2). FDA contracted for an 
independent evaluation of the data in the petition by the U.S. 
Department of Energy, Oak Ridge National Laboratory (ORNL) (Ref. 3). 
The references provide the primary basis for FDA's conclusion regarding 
the safety of the petitioned use of neutron radiation.
    The Harwell Report assessed the radiological implications of the 
use of neutron-based cargo surveillance techniques on cargoes of food. 
Three cargo scenarios were investigated; semi-infinite slabs 
(representing inspection of a large transport container of food), 1 
kilogram (kg) of food in a 20-kg suitcase (representing airport 
inspection of a piece of luggage containing a small quantity of food 
(e.g., a lunch)), and 2-meter high pallets of food. Calculations were 
made for 17 different types of food simulating exposure to 0.5 Gy of 
neutrons (50 times higher than the maximum petitioned dose level of 
0.01 Gy) with energies of 1, 2, 5, 8, and 14 MeV. Calculations included 
induced activities and the resultant doses to consumers after ingesting 
foods 5 minutes to 1 month after inspection. In addition, in selecting 
the food to be used for the cargo scenarios, three types of food were 
considered for the calculations based upon the chemical elements of the 
foods (e.g. calcium, iron, magnesium, sodium, potassium): A single 
distribution representing the maximum credible concentrations of the 
elements in any food; a single ``reference'' distribution of 47 
elements obtained from studies of dietary intake; and distributions 
corresponding to elemental concentrations in 17 common food types. Of 
these three distributions, the one considered the most realistic was 
the single ``reference'' distribution because it is based on the daily 
elemental requirements for ``reference'' man. For this distribution, 
the report provided calculations of radiation dose per unit activity 
intake into the body for induced activities of the neutron-irradiated 
``reference'' food at a consumption rate of 2.88 kg of food per day and 
the resultant dose to reference man after ingesting the foods 
immediately after inspection and up to 1 month after inspection. Prior 
to irradiation, the ingestion dose of ``reference'' food is reported to 
be 1.823 x10-10 Sieverts per gram (Sv/g). The authors 
calculated that, depending on the energy of the neutron beam and an 
absorbed dose in the reference food of 0.5 Gy, the ingestion doses from 
consuming the ``reference'' food 1 hour, 8 hours, and 1 day after 
irradiation would range from 9.2 x 10-10 to 3.2 x 
10-9 Sv/g, 5.3 x 10-10 to 1.7 x 10-9 
Sv/g, and 3.7 x10-10 to 9.2x10-10 Sv/g, 
respectively. As this example and others below illustrate, any induced 
radioactivity is small and dissipates rapidly. Therefore, within 1 day, 
the ingestion dose from inspected foods

[[Page 76403]]

would be essentially the same from natural radioactivity in the same 
food. FDA notes that the Harwell Report addresses a neutron dose 50 
times higher than that proposed in the petition and reports 
radioactivity in the food within 24 hours of inspection. Because food 
subject to this regulation would be inspected at a far lower dose, and 
would unlikely be consumed within 24 hours of inspection considering 
the logistics of food transportation, any residual induced 
radioactivity would be well below what occurs naturally.
    The calculations provided by the petitioner were based on computer 
modeling and estimated the committed effective dose equivalents to 
adults, children, and infants due to ingestion of neutron-radiation 
inspected foods 12 hours after exposure to an 8 MeV neutron fluence 
rate of 5 x 105 n cm-2sec-1, for a 
period of 1 second, corresponding to a dose of 0.021 milliGray (mGy). 
The petitioner identified representative foods, the elemental 
composition of each food, and typical values for the annual amount of 
each food ingested. The calculated annual effective doses from 
consumption of foods that have been irradiated ranged from 3.42 x 
10-11 to 2.01 x 10-8 Sv, which is significantly 
below the annual effective dose from natural radioactivity in food that 
is reported to be 3.9 x 10-4 Sv per year\1\. Although the 
absorbed dose in this study is approximately 500 times less than the 
maximum petitioned dose level of 0.01 Gy (10 mGy), the calculated 
annual effective dose from foods inspected with high energy neutrons is 
20 thousand to 11 million times less than the annual effective dose 
from naturally occurring radioactivity in food.
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    \1\This dose is based on data from the National Council on 
Radiation Protection and Measurements, Ionizing Radiation Exposures 
of the Population of the United States, 1987.
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    ORNL performed an independent assessment for a subset of foods 
considered by the petitioner, and ingestion doses per unit of food were 
found to be in general agreement with those presented in the 
petitioner's supportive documentation. In addition, ORNL designed three 
extreme-case scenarios regarding consumption of food inspected with 
pulsed fast neutrons. One scenario assumed the entire diet has been 
irradiated for 1 second and then consumed 12 hours later. This 
scenario, although highly conservative, is considered to be the most 
reasonable of the three. The second scenario assumed infrequent 
(equivalent to 10 full days of dietary needs per year) consumption of 
food 5 minutes after it had been irradiated for 1 second. The third 
scenario assumes infrequent tasting of food immediately after it had 
been irradiated for 5 minutes. The calculated annual effective doses 
for each scenario is 4.8x10-8 Sv, 3.4x10-7 Sv, 
and 1.0x10-5 Sv, respectively, which are approximately 40 to 
8,000 times less than the annual effective dose from consumption of 
foods due to naturally occurring radioactivity.

D. Need for a Lower Energy Limit

    The petitioner proposed a range of up to 9 MeV and with no lower 
limit, for the source's average neutron energy. Fast neutrons with high 
energy (greater than 1 MeV) are necessary to penetrate large cargo 
containers, whereas lower energy neutrons (less than 1 MeV), including 
thermal neutrons, have less penetrating power and are more likely to 
induce radioactivity in food. Therefore, FDA considered whether the 
data in the petition demonstrate that a source of high energy neutrons 
would require a lower energy limit to ensure safe use. Although the 
petitioner originally proposed a neutron energy range up to 9 MeV, the 
Harwell Report which was submitted by the petitioner is based on 
neutron energy levels ranging from 1 to 14 MeV and, therefore, supports 
the safety of neutron energies within that range. Because the data in 
the petition do not adequately address the issue of induced 
radioactivity from neutrons of energy below 1 MeV, and because neutrons 
with such energy levels are not explicitly intended to be used, FDA 
concludes that a minimum energy level requirement of 1 MeV is 
appropriate. In addition to this lower energy limit, FDA has also 
concluded that, based on information in the petition, it is necessary 
to restrict the neutron source to one that produces monoenergetic 
neutrons. A monoenergetic source produces neutrons within a narrow 
energy distribution compared to a source that is not monoenergetic. 
Such a restriction will limit the number of lower energy neutrons that 
are emitted even if the source's average neutron energy is 1 MeV.

IV. Conclusion of Safety

    FDA has evaluated the data submitted in the petition and other 
relevant material and concludes that consumption of food inspected by a 
source of monoenergetic neutrons between 1 and 14 MeV is safe, and that 
the conditions listed in Sec.  179.21 should be amended as set forth 
below. In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the 
petition and the documents that FDA considered and relied upon in 
reaching its decision to approve the petition are available for 
inspection at the Center for Food Safety and Applied Nutrition by 
appointment with the information contact person (see FOR FURTHER 
INFORMATION CONTACT). As provided in Sec.  171.1(h), the agency will 
delete from the documents any materials that are not available for 
public disclosure before making the documents available for inspection.

V. Environmental Impact

    The agency has determined under 21 CFR 25.32(j) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an EA nor an 
environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    This final rule contains information collection requirements that 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
title, description, and respondent description of the information 
collection requirements are shown below with an estimate of the annual 
reporting burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing each 
collection of information.
    Title: Irradiation in the Production, Processing, and Handling of 
Food
    Description: The regulation as amended requires that monoenergetic 
neutron sources producing neutrons at energies not less than 1 MeV but 
no greater than 14 MeV used for inspection of container shipments which 
may contain food bear a label stating the minimum and maximum energy of 
radiation emitted by the neutron source. The label or accompanying 
labeling shall also bear adequate directions for safe use and a 
statement that no food shall be exposed to this radiation source so as 
to receive a dose in excess of 0.01 Gy. This information is needed to 
ensure safe use of the source of radiation as a direct food additive.
    Description of Respondents: Manufacturers of monoenergetic neutron 
radiation source.

[[Page 76404]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                                                                        Total Operating
         21 CFR Section                 No. of         Annual Frequency      Total Annual         Hours  per          Total Hours       and Maintenance
                                      Respondents        per Response          Responses           Response                                  Costs
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179.21(a)(5), (b)(1)(iv), and                     1                   1                   1                   1                   1                $100
 (b)(2)(v)
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\1\There are no capital costs associated with this collection of information.

    Estimated Annualized Cost for the Burden Hours
    The operating and maintenance cost associated with this collection 
is $100 for preparation of labels.
    The information collection requirements in this final rule have 
been approved under OMB control number 0910-0549. This approval expires 
January 31, 2005. An agency may not conduct or sponsor, and a person is 
not required to respond to, a collection of information unless it 
displays a currently valid OMB control number.

VII. Objections

    Any person who will be adversely affected by this regulation may 
file with the Division of Dockets Management (see ADDRESSES) written or 
electronic objections. Each objection shall be separately numbered, and 
each numbered objection shall specify with particularity the provisions 
of the regulation to which objection is made and the grounds for the 
objection. Each numbered objection on which a hearing is requested 
shall specifically so state. Failure to request a hearing for any 
particular objection shall constitute a waiver of the right to a 
hearing on that objection. Each numbered objection for which a hearing 
is requested shall include a detailed description and analysis of the 
specific factual information intended to be presented in support of the 
objection in the event that a hearing is held. Failure to include such 
a description and analysis for any particular objection shall 
constitute a waiver of the right to a hearing on the objection. Three 
copies of all documents are to be submitted and are to be identified 
with the docket number found in brackets in the heading of this 
document. Any objections received in response to the regulation may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

VIII. References

    The following references have been placed on display in the 
Division of Dockets Management and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Findlay, D. J. S., R. A. Forrest, and G. M. Smith, ``Neutron-
Induced Activation of Food,'' (Harwell Report), AEA-InTec-1051, 
1992.
    2. Ryge, P., I. Bar-Nir, M. Simic, ``Food Safety Effects of 
Inspection by SAIC Pulsed Fast Neutron Analysis Explosive Detection 
System,'' SAIC, 1992.
    3. Easterly, C. E., K. F. Eckerman, R. H. Ross, D. M. Opresko, 
``Assessment of Petition to Use Pulsed Fast Neutron Analysis (PFNA) 
in Inspection of Shipping Containers Containing Foods,'' Oak Ridge 
National Laboratory, Life Sciences Division, 2003.

List of Subjects in 21 CFR Part 179

    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
symbols.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Director, Center for Food Safety and Applied 
Nutrition, 21 CFR part 179 is amended as follows:

PART 179--IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF 
FOOD

0
1. The authority citation for 21 CFR part 179 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.

0
2. Section 179.21 is amended by adding paragraphs (a)(5), (b)(1)(iv), 
and (b)(2)(v) to read as follows:


Sec.  179.21  Sources of radiation used for inspection of food, for 
inspection of packaged food, and for controlling food processing.

* * * * *
    (a) * * *
    (5) Monoenergetic neutron sources producing neutrons at energies 
not less than 1 MeV but no greater than 14 MeV.
    (b) * * *
    (1) * * *
    (iv) The minimum and maximum energy of radiation emitted by neutron 
source.
    (2) * * *
    (v) A statement that no food shall be exposed to a radiation source 
listed in paragraph (a)(5) of this section so as to receive a dose in 
excess of 0.01 gray (Gy).

    Dated: December 14, 2004.
Leslye M. Fraser,
Director, Office of Regulations and Policy, Center for Food Safety and 
Applied Nutrition.
[FR Doc. 04-27868 Filed 12-20-04; 8:45 am]
BILLING CODE 4160-01-S