[Federal Register Volume 65, Number 210 (Monday, October 30, 2000)]
[Rules and Regulations]
[Pages 64605-64607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27735]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket No. 99F-673]
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
to control microbial pathogens in seeds for sprouting. This action is
in response to a petition filed by Caudill Seed Co., Inc.
DATES: This regulation is effective October 30, 2000. Submit written
objections and requests for a hearing by November 29, 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: Lane A. Highbarger, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3032.
[[Page 64606]]
SUPPLEMENTARY INFORMATION:
I. Background
In a notice published in the Federal Register of August 16, 1999
(64 FR 44530), FDA announced that a food additive petition (FAP 9M4673)
had been filed by Caudill Seed Co., Inc., 1402 West Main St.,
Louisville, KY 40203. 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 sources of ionizing radiation to control microbial pathogens in
alfalfa and other sprouting seeds.
II. Safety Evaluation
Under section 201(s) of the Federal Food, Drug, and Cosmetic 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 number of microbial pathogens in or on
seeds for sprouting.
The petitioner submitted published articles and other study reports
containing data and information related to seeds for sprouting 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 seeds treated
with ionizing radiation prior to sprouting.
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 (``radiolysis products'') depend on the chemical constituents
of the food and on the conditions of irradiation. Furthermore, the
principles of radiation chemistry govern the extent of changes, if any,
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 for FDA's discussion of
radiation chemistry, nutrition, toxicology, and microbiology related to
irradiation of foods under various conditions of use (62 FR 64107,
December 3, 1997).
FDA has reviewed the relevant data and information submitted in the
petition regarding radiation chemistry as it applies to seeds for
sprouting, as well as data readily available and in the agency's files.
FDA has concluded that the concentrations and types of radiolysis
products formed by the irradiation of seeds for sprouting will be
comparable to those products produced by the irradiation of foods of
similar composition (Ref. 1). Most of these radiolysis products are
formed in very small amounts and are either the same as, or
structurally similar to, compounds found in foods that have not been
irradiated. Thus, the chemical composition of sprouts grown from
irradiated seeds will not differ in any significant manner from sprouts
grown from seeds that have not been irradiated.
This petition contained no toxicity studies on the sprouts grown
from irradiated seeds. Nonetheless, a review of the agency's data base
and submitted published references of toxicological studies related to
irradiated foods, combined with the fact that only negligible amounts
of radiolysis products are expected to be present in the sprouts that
are grown from irradiated seeds for sprouting, show that the estimated
exposure of an individual to these radiolytic products will be
negligible. Therefore, FDA has determined that no toxicity concerns are
raised from the petitioned use of irradiation on seeds for sprouting
(Ref. 2).
The purported technical effect of irradiating seeds for sprouting
is to control the level of microbial pathogens. FDA evaluated data on
the relation between various doses of radiation and the reduction of
detectable levels of coliforms generally, and Escherichia coli 0157:H7
and Salmonella serotype Stanley specifically. The petitioner found
that, depending on the pathogen and other factors, between 3 and 5
KiloGray (kGy) of irradiation would reduce the amount of pathogens to
below detectable levels (Ref. 3). To accommodate the uncertainty of
irradiation treatment and dose variation due to absorption by the
target, the petitioner requested a maximum irradiation dose of 8 kGy.
The agency has determined that irradiation of seeds for sprouting at
levels up to 8 kGy will have the desired effect of controlling the
levels of microbial pathogens on seeds for sprouting (Ref. 3).
Regarding the nutritional aspects of irradiating seeds for
sprouting, it is well documented that protein, fat, and minerals are
not significantly altered by irradiation within the given dose range
requested in this petition (Ref. 2). The petitioner evaluated the
potential loss of vitamins from irradiation of seeds for sprouting.
Although there was a great deal of variability in vitamin levels of the
seeds tested (e.g., in studies submitted by the petitioner, vitamin A
content of sprouts grown from control seeds was actually lower than
that for sprouts grown from irradiated seeds), researchers did not
observe any significant losses of any of the vitamins in the resultant
sprouts (up to 6 kGy) when compared to nonirradiated controls. Any loss
of vitamins, even if it occurs, is expected to be inconsequential when
compared to total dietary nutrient consumption (Ref. 2). FDA therefore
concludes, based on all the evidence before it, that irradiation of
seeds for sprouting under the conditions set forth in the regulation
below will not have an adverse impact on the nutritional adequacy of a
person's diet.
III. Labeling
FDA has also considered whether irradiated seeds for sprouting and
sprouts grown from such seeds must bear special labeling. In
particular, FDA evaluated the application of Sec. 179.26(c) (21 CFR
179.26(c)) to these products.
A. Seeds for Sprouting
Since any permissible use of ionizing radiation on seeds for
sprouting must be in conformance with Sec. 179.26(b), the label and
labeling of such seeds for sprouting must comply with the requirements
in Sec. 179.26(c).
B. Sprouts Grown From Irradiated Seeds for Sprouting
It is important to recognize that in the use of radiation that is
the subject of this rule, the irradiated article is not what is
generally eaten because the unsprouted seeds are not normally consumed.
While irradiation of the seeds for sprouting may cause some changes in
the seed (for example, reduced viability of sprouting), the nutritional
and flavor characteristics of the sprouts will derive from the fact
that they were grown and not from the fact that the seeds were
processed by irradiation. Moreover, the agency has no reason to believe
that sprouts grown from irradiated seeds will differ in their sensory
characteristics from sprouts grown from seeds that have not been
irradiated. Therefore, the agency concludes that sprouts grown
[[Page 64607]]
from seeds that have been irradiated need not be labeled as treated by
irradiation where the sprouts themselves have not been irradiated.
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 seeds for sprouting at levels not to exceed 8 kGy
is safe, (2) the irradiation will achieve its intended technical
effect, and therefore, (3) the regulations in Sec. 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.
IV. 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 environmental
assessment nor an environmental impact statement is required.
V. 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 November 29, 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 shall be
submitted and shall 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.
VI. 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. FDA Memorandum, K. Morehouse to J. Ziyad, February 23, 2000.
2. FDA Memorandum, I. Chen to J. Ziyad, February 28, 2000.
3. FDA Memorandum, M. Walderhaug to J. Ziyad, December 15, 1999.
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 ``10.'' 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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10. For control of microbial Not to exceed 8.0 kGy.
pathogens on seeds for sprouting.
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* * * * *
Dated: October 20, 2000.
L. Robert Lake,
Director of Regulations and Policy, Center for Food Safety and Applied
Nutrition.
[FR Doc. 00-27735 Filed 10-27-00; 8:45 am]
BILLING CODE 4160-01-F