[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.

* * * * *
    (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