[Federal Register Volume 65, Number 141 (Friday, July 21, 2000)]
[Rules and Regulations]
[Pages 45280-45282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-18496]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
SUPPLEMENTARY INFORMATION:
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
radiation.
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
irradiation.)
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
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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://www.nal.usda.gov/fnic/foodcomp.
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
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 179.26 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.
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(b) * * *
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Use Limitations
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9. For control of Salmonella in Not to exceed 3.0 kGy.
fresh shell eggs.
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Dated: July 14, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied
Nutrition.
[FR Doc. 00-18496 Filed 7-20-00; 8:45 am]
BILLING CODE 4160-01-F