[Federal Register: July 21, 2000 (Volume 65, Number 141)]
[Rules and Regulations]               
[Page 45280-45282]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
Food and Drug Administration
21 CFR Part 179
[Docket No. 98F-0165]
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 ionizing radiation 
for the reduction of Salmonella in fresh shell eggs. This action is in 
response to a petition filed by Edward S. Josephson.
DATES: This rule is effective July 21, 2000. Submit written objections 
and requests for a hearing by August 21, 2000.
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: William J. Trotter, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3088.
I. Background
    In a notice published in the Federal Register of March 20, 1998 (63 
FR 13675), FDA announced that a food additive petition (FAP 8M4584) had 
been filed by Edward S. Josephson, University of Rhode Island, Food 
Science and Nutrition Research Center, 530 Liberty Lane, West Kingston, 
RI 02892-1802. The petitioner proposed that the food additive 
regulations in part 179 Irradiation in the Production, Processing and 
Handling of Food (21 CFR part 179) be amended to provide for the safe 
use of ionizing radiation for the reduction of Salmonella in fresh 
shell eggs.
II. Safety Evaluation
    Under section 201(s) of the Federal Food, Drug, and Cosmetic Act 
(the act) (21 U.S.C. 321(s)), a source of radiation used to treat food 
is defined as a food additive. The additive is not, literally, added to 
food. Instead, a source of radiation is used to process or treat food 
such that, analogous to other food processes, its use can affect the 
characteristics of the food. In the subject petition, the intended 
technical effect is a change in the microbial load of the food, 
specifically, a reduction in the numbers of Salmonella, a human 
pathogen, in or on fresh shell eggs.
    The petitioner submitted published articles and other study reports 
containing data and information related to eggs and other kinds of food 
in the areas of radiation chemistry, nutrition, toxicology, and 
microbiology. FDA has fully considered the data and studies submitted 
in the petition, as well as other information in its files relevant to 
the safety and nutritional adequacy of eggs treated with ionizing 
    The effects of ionizing radiation on the characteristics of treated 
foods are a direct result of the chemical reactions induced by the 
absorbed radiation. Scientists have compiled a large body of data 
regarding the effects of ionizing radiation on different foods under 
various conditions of irradiation. Research has established that the 
types and amounts of products generated by radiation-induced chemical 
reactions (hereinafter referred to as "radiolysis products") depend 
on the chemical constituents of the food and on the conditions of 
irradiation (e.g., temperature and presence or absence of air and 
moisture). Furthermore, the principles of radiation chemistry govern 
the extent of changes both in the nutrient levels and in the microbial 
load of irradiated foods. Key factors include the specific nutrient or 
microorganism of interest, the food, and the conditions of irradiation. 
(See the agency's final rule permitting the irradiation of meat (the 
meat final rule) in the Federal Register of December 3, 1997 (62 FR 
64107) for FDA's discussion of radiation chemistry, nutrition, 
toxicology, and microbiology related to irradiation of foods composed 
primarily of water, protein, and lipids under various conditions of 
    FDA has reviewed the relevant data and information submitted in the 
petition regarding the radiation chemistry of fresh shell eggs, and 
data available in the agency's files. Fresh whole eggs are composed 
mainly of water (75.3 percent), protein (12.5 percent), and lipid (10.0 
percent) (Ref. 1). As discussed in the meat final rule, the radiation 
chemistry associated with these types of compounds is well known. FDA 
has concluded that the concentrations and types of radiolysis products 
formed by the irradiation of eggs will be comparable to those products 
produced by the irradiation of other foods of similar composition, such 
as meat (Ref. 2). In addition, the petitioner's data support the 
conclusion that there is little change in the levels of individual 
fatty acids, or in the structure, digestibility, or biological value of 
protein, when shell eggs are treated with ionizing radiation up to 3 
kiloGray (kGy) (Refs. 2 and 3). Most of the radiolysis products are 
either the same as, or structurally similar to, compounds found in 
foods that have not been irradiated, and are formed in very small 
amounts. In summary, an absorbed dose of 3 kGy for the irradiation of 
fresh shell eggs will result in only minimal changes in the 
macronutrients (protein, lipid, or carbohydrate), and the chemical 
composition of eggs will not differ in any significant manner from eggs 
that have not been irradiated.
    The petitioner submitted studies and published reports relevant to 
the safety of irradiated foods, in general. In addition, a variety of 
irradiated foods including: Red meat, chicken, fish, and eggs, have 
been tested in earlier animal feeding studies and genotoxicity studies; 
and they were previously reviewed by FDA (see, e.g., 62 FR 64107, 
December 3, 1997). Included in the information considered by FDA in the 
review of this petition are three studies conducted specifically on 
irradiated eggs (Ref. 4). In the first such study, rats were fed a 
biscuit diet containing whole eggs irradiated at 5 kGy at a dietary 
level of 25 percent on a dry weight basis for 3 years (two 
generations). No adverse effects were observed compared to the control 
group fed a diet containing nonirradiated eggs. In the second study, 
mice and rats were fed a diet containing dried eggs irradiated at 93 
kGy and irradiated pork brain. No effects were observed that were 
attributed to the irradiated food. In the third study, rats were fed 
canned eggs irradiated at 5 kGy in their diet for two generations. No 
effects were observed that were attributed to the irradiated diet. 
Taken as a whole, based on the totality of evidence from all evaluated 
data and studies, FDA concludes that the petitioned use of
[[Page 45281]]
irradiation on fresh shell eggs raises no toxicity concerns (Refs. 4 
and 5).
    FDA also evaluated the effects of irradiation processing on 
micronutrients (e.g., minerals, water-soluble vitamins, and fat-soluble 
vitamins). Minerals are unaffected by irradiation, but the levels of 
some vitamins may be reduced as a result of irradiation. For example, 
vitamin A levels did decrease with an increasing radiation dose. Not 
all vitamin loss is significant, however. The extent to which a 
reduction in a specific vitamin level is significant depends on the 
relative contribution from the food in question to the dietary intake 
of the vitamin and the overall sufficiency of the vitamin in the diet. 
Based upon data in the agency's files, FDA concludes that the intake of 
vitamins from other foods compensates for the vitamin loss from the 
irradiation of eggs (Refs. 4 and 5). For example, a fresh unirradiated 
egg contains approximately 95 retinol equivalents (RE) of Vitamin A 
(Ref. 4). In a study, shell eggs irradiated at 1.0 kGy and stored for 
24 days contained approximately 72 RE's (Ref. 3). In comparison, 1 
tablespoon of butter contains 108 RE's, one-half cup of bran cereal 
contains 258 RE's, and one-half cup of canned carrots contains 1,620 
RE's of vitamin A (Ref. 4). FDA, therefore, concludes, based upon all 
the evidence before it, that irradiation of fresh shell eggs under the 
conditions set forth in the regulation below will not have an adverse 
impact on the nutritional adequacy of a person's diet.
    Increased irradiation levels can also cause organoleptic changes in 
the egg. For example, data in the petition showed an increased color 
loss in the irradiated egg yolk and a change in the egg's viscosity as 
the radiation dose was increased. Thus, FDA expects that the 
acceptability of irradiated shell eggs, based on their color and 
viscosity, will limit, in a practical way, the maximum dose of 
irradiation applied to fresh shell eggs. Therefore, FDA has determined 
that there is no need to limit the irradiation level based on changes 
in micronutrient levels or organoleptic characteristics of the eggs.
    Irradiation of fresh shell eggs at the doses requested in the 
petition will reduce, but not entirely eliminate, microorganisms in 
eggs. The stated purpose of this petition is for approval of radiation 
of fresh shell eggs to reduce the number of Salmonella. The data show 
that low dose irradiation in the range requested by the petitioner can 
reduce the levels of S. enteritidis in fresh shell eggs (Ref. 6). 
Salmonella strains, in addition to S. enteritidis, in fresh shell eggs 
should also be reduced by irradiation since S. enteritidis was found to 
have similar sensitivities to ionizing radiation as five other strains 
of Salmonella that were tested in various media (Ref. 7).
    Based on the data and studies submitted in the petition and other 
information in the agency's files, FDA concludes that: (1) The proposed 
use of irradiation on fresh shell eggs at levels not to exceed 3.0 kGy 
is safe, (2) the irradiation can achieve its intended technical effect 
and, therefore, (3) the regulations in Sec. 179.26 (21 CFR 179.26) 
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.
    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
III. Environmental Impact
    The agency has previously considered the environmental effects of 
this rule as announced in the filing notice for FAP 8M4584 (63 FR 
13675, March 20, 1998). No new information or comments have been 
received that would affect the agency's previous determination that 
there is no significant impact on the human environment and that an 
environmental impact statement is not required.
IV. 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 August 21, 2000. 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 Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.
V. References
    The following references have been placed on display at 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. Nutrient Data Laboratory Food Composition Data, USDA 
Agricultural Research Service, available at Internet address: http:/
    2. Memorandum from K. Morehouse, FDA, to W. Trotter, FDA, May 
14, 1999.
    3. Memorandum from K. Morehouse, FDA, to W. Trotter, FDA, April 
11, 2000.
    4. Memorandum from I. Chen, FDA, to W. J. Trotter, FDA, December 
11, 1998.
    5. Memorandum from I. Chen, FDA, to W. J. Trotter, FDA, March 
31, 2000.
    6. Memorandum from V. K. Bunning, FDA, to W. J. Trotter, FDA, 
April 4, 2000.
    7. Thayer, D.W., et al., "Radiation Resistance of Salmonella," 
Journal of Industrial Microbiology, 5:383-390, 1990.
List of Subjects in 21 CFR Part 179
    Food additives, Food labeling, Food packaging, Radiation 
protection, Reporting and recordkeeping requirements, Signs and 
    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:
    1. The authority citation for 21 CFR part 179 continues to read as 
    Authority: 21 U.S.C. 321, 342, 343, 348, 373, 374.
    2. Section 179.26 is amended in the table in paragraph (b) by 
adding entry "9." under the headings "Use" and "Limitations" to 
read as follows:
Sec. 179.26  Ionizing radiation for the treatment of food.
* * * * *
    (b) * * *
[[Page 45282]]
                Use                              Limitations
  *                    *                    *                    *
                   *                    *                    *
9. For control of Salmonella in      Not to exceed 3.0 kGy.
 fresh shell eggs.
* * * * *
    Dated: July 14, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied 
[FR Doc. 00-18496 Filed 7-20-00; 8:45 am]