[Federal Register Volume 66, Number 69 (Tuesday, April 10, 2001)]
[Rules and Regulations]
[Pages 18537-18539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8755]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 94F-0008]


 Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the food 
additive regulations to provide for the safe use of a machine source of 
high energy x-rays to inspect cargo containers that may contain food. 
This action is in response to a petition filed by Analytical Systems 
Engineering Corp. (ASEC).

DATES: This rule is effective April 10, 2001. Submit written objections 
and request for a hearing by May 10, 2001.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3095.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of February 24, 1994 
(59 FR 8995), FDA announced that a food additive petition (FAP 4M4407) 
had been filed by Analytical Systems Engineering Corp., 5400 Shawnee 
Rd., suite 100, Alexandria, VA 22312. 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 machine source of high energy x-rays to inspect cargo 
containers that may contain food. In a letter dated October 12, 2000, 
ASEC (now ACS Defense, Inc., 2001 North Beauregard St., Alexandria, VA 
22311) informed FDA of the transfer of their rights to FAP 4M4407 to R. 
F. Reiter and Associates, 850 Oak Chase Circle, Fairfax Station, VA 
22039.

II. Evaluation of Safety

    A source of radiation used for the purpose of inspection of foods 
meets the definition of a food additive under 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 Sec. 170.3(i) 
(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.''

[[Page 18538]]

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

    Machine sources that produce high energy x-rays may be used to 
screen large cargo containers for illegal drugs and other contraband. 
To be able to penetrate large cargo containers, these x-ray systems 
need to operate with x-ray energies higher than those used for 
screening smaller articles (Ref. 1). The present petition proposes the 
use of x-rays produced by an electron linear accelerator operating at 
energy levels of up to 10 million electron volts (MeV) to inspect large 
cargo containers that may contain food, provided that the maximum dose 
absorbed by the food does not exceed 0.5 gray (0.5 Gy). Because the 
probability of inducing a change in the nucleus of an atom absorbing x-
rays increases with the energy of the x-ray, the potential for induced 
radioactivity in the finished foodstuff needs to be assessed. Current 
regulations authorize the use of x-rays at energies up to 0.5 MeV to 
inspect cargo, including food, provided the absorbed dose does not 
exceed 10 Gy (Sec. 179.21). This petition seeks to raise the energy 
limit for x-rays from 0.5 MeV to 10 MeV, however, the petition also 
proposes to limit the maximum absorbed dose to 0.5 Gy, well below the 
10 Gy level previously established as safe for food inspection. 
Accordingly, FDA has concluded that there is no need to evaluate 
changes in the food subjected to x-rays other than the potential for 
induced radioactivity.
    The petitioner submitted a number of published articles and other 
study reports containing data and information on the induction of 
radioactivity in food. One of the reports that the petitioner relied on 
to demonstrate that the petitioned use of the source of radiation is 
safe is from the World Health Organization (WHO). This WHO report 
concluded that no detectable radioactivity will be induced in 
foodstuffs by x-rays with a maximum energy level of 10 MeV when a dose 
of 0.5 Gy is not exceeded (Ref. 1).
    As part of FDA's safety review of the petition, the agency 
evaluated two studies in which various foods were irradiated with 
either x-rays or electron beams at energies sufficient to induce 
radioactivity. Radioactivity is the result of changes in the nucleus of 
an atom induced, for example, by interaction with x-rays. Because the 
elemental composition of the foods that were studied is representative 
of foods in general, the results of the two studies may reasonably be 
applied to other foods subjected to these test conditions. In one 
study, three types of food were irradiated with high energy 
bremsstrahlung\1\ produced by an electron linear accelerator that 
generated predominately 8 MeV electrons (approximately 7 percent of the 
electrons were in the range of 8 to 10 MeV and less than 2 percent were 
in the range of 10 to 12 MeV) (Ref. 2). The types of food that were 
irradiated were codfish, rice, and a macerated meat product. These 
foods received doses ranging from 8.8 to 14 kiloGy (kGy) (17,600 to 
28,000 times higher than the maximum petitioned dose level of 0.5 Gy). 
The authors concluded that the induced activities in the foods that 
were observed immediately after irradiation are approximately the same 
as natural background levels, and that any induced activities drop 
quickly. According to the data presented in the paper, by 1 day after 
irradiation, induced levels of radioactivity were typically about 10 
percent of those initially observed. Because of the extremely small 
level of radioactivity that was induced in foods after receiving doses 
thousands of times higher than the maximum petitioned dose, FDA would 
not expect any detectable radioactivity above background in food 
resulting from the petitioned use of the source of radiation at doses 
up to 0.5 Gy.
---------------------------------------------------------------------------

    \1\ Bremsstrahlung refers to the type of radiation which is 
emitted when high-speed electrons are suddenly decelerated due to 
interactions with atomic nuclei.
---------------------------------------------------------------------------

    In the second study, samples of chicken, prawns, cheeses, and 
spices were irradiated with electron beams at energies of 10 MeV and 20 
MeV and induced radioactivity was measured (Ref. 3). In this study, the 
mechanisms responsible for the induced radioactivity in the samples 
were photonuclear reactions induced by bremsstrahlung and 
electronuclear reactions induced by the electron beams. The authors 
noted that when food is irradiated with electron beams with an energy 
at or below 10 MeV, the induced radioactivity in food is essentially 
zero. Therefore, to produce measurable radioactivity in food, 
irradiations were also carried out at 20 MeV. The authors stated that 
the study with 20 MeV irradiations was intended to simulate a gross 
malfunction of an electron beam irradiation plant. The authors 
concluded that, as expected, no measurable radioactivity induced at 10 
MeV was detected, and that even at energies as high as 20 MeV and doses 
up to 10 kGy (i.e., 20,000 times the maximum petitioned dose level of 
0.5 Gy), the specific activity after 1 day was approximately 0.01 
Becquerel/gram (Bq/g), which is negligible (Ref. 3).

IV. Conclusion of Safety

    FDA has evaluated the data submitted in the petition and other 
relevant material and concludes that no detectable radioactivity will 
be induced in food when an x-ray energy of 10 MeV and a dose of 0.5 Gy 
are not exceeded. Therefore, the agency concludes that the proposed use 
of x-radiation, produced by a machine source at energies of 10 MeV or 
lower, to inspect food, 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 listed above. 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

    In the notice of filing, FDA gave interested parties an opportunity 
to submit comments on the petitioner's environmental assessment. FDA 
received no comments in response to that notice. The agency has 
carefully considered the potential environmental effects of this 
action. FDA has concluded that this action will not have a significant 
impact on the human environment, and that an environmental impact 
statement is not required. The agency's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Dockets Management Branch 
(address above) between 9 a.m. and 4 p.m., Monday through Friday.

VI. Paper Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Objections

    Any person who will be adversely affected by this regulation may at 
any time file with the Dockets Management Branch (address above) 
written objections by May 10, 2001. 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

[[Page 18539]]

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 Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

VIII. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. WHO, ``Food safety aspects relating to the application of X-
ray surveillance equipment: Memorandum from a WHO meeting,'' 
Bulletin of the World Health Organization, vol. 31, pp. 297-301, 
1990.
    2. Wakeford, C. A. and R. Blackburn, ``Induction and Detection 
of Radioactivity in Foodstuffs Irradiated with 10 MeV Electrons and 
X-rays,'' Radiation Physics and Chemistry, vol. 38, No. 1, pp. 29-
38, 1991.
    3. Findley, D. J. S., T.V. Parson, and M. R. Sene, 
``Experimental Electron Beam Irradiation of Food and the Induction 
of Radioactivity,'' Applied Radiation and Isotopes, vol. 43, pp. 
567-575, 1992.

List of Subjects in 21 CFR Part 179

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

    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

    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.

    2. Section 179.21 is amended by adding paragraphs (a)(4), 
(b)(1)(iii), and (b)(2)(iv) 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) *  *  *
    (4) Machine sources producing X-radiation at energies no greater 
than 10 million electron volts (MeV).
    (b) *  *  *
    (1) *  *  *
    (iii) The maximum energy of X-radiation emitted by machine source.
    (2) *  *  *
    (iv) A statement that no food shall be exposed to a radiation 
source listed in paragraph (a)(4) of this section so as to receive a 
dose in excess of 0.5 gray (Gy).

    Dated: April 3, 2001.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
Nutrition.
[FR Doc. 01-8755 Filed 4-9-01; 8:45 am]
BILLING CODE 4160-01-S