Document ID: FDA-1999-F-0021-0003
Agency: fda
Document Type: Rule
Title: Irradiation in the Production, Processing and Handling of Food
Posted Date: 2012-05-11T04:00Z

[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27586-27590]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11391]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. FDA-1999-F-0021; formerly 1999F-2673]

Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; denial of requests for a hearing and response to 
objections.

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SUMMARY: The Food and Drug Administration (FDA) is denying requests for 
a hearing on the final rule that amended the food additive regulations 
to provide for the safe use of ionizing radiation for the control of 
microbial pathogens in seeds for sprouting. After reviewing objections 
to the final rule and requests for a hearing, FDA has concluded that 
the objections do not justify a hearing or otherwise provide a basis 
for revoking the regulation.

FOR FURTHER INFORMATION CONTACT: Teresa A. Croce, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1281.

SUPPLEMENTARY INFORMATION: 

I. Introduction

    In the Federal Register of August 16, 1999 (64 FR 44530), FDA 
published a notice announcing the filing of a food additive petition 
(FAP 9M4673) submitted by Caudill Seed Co., Inc., to amend the 
regulations in part 179 Irradiation in the Production, Processing, and 
Handling of Food (21 CFR part 179) by providing for the safe use of 
ionizing radiation to control microbial pathogens in seeds for 
sprouting. In response to this petition, FDA issued a final rule in the 
Federal Register of October 30, 2000 (65 FR 64605), permitting the 
irradiation of seeds for sprouting to control microbial pathogens in 
alfalfa and other sprouting seeds at an absorbed dose not to exceed 8.0 
kiloGray (kGy) (hereafter referred to as the ``seeds for sprouting 
rule''). FDA based its decision on data in the petition and in its 
files. The preamble to the final rule advised that objections to the 
final rule and requests for a hearing were due within 30 days of the 
publication date (i.e., by November 29, 2000).

II. Objections and Requests for a Hearing

    Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 348(f)(1)) provides that, within 30 days after publication of an 
order relating to a food additive regulation, any person adversely 
affected by such order may file objections, ``specifying with 
particularity the provisions of the order deemed objectionable, stating 
reasonable grounds therefor [sic], and requesting a public hearing upon 
such objections.''
    Under the food additive regulations at 21 CFR 171.110, objections 
and requests for a hearing are governed by part 12 (21 CFR part 12) of 
FDA's regulations. Under Sec.  12.22(a), each objection must meet the 
following conditions: (1) Must be submitted on or before the 30th day 
after the date of publication of the final rule; (2) must be separately 
numbered; (3) must specify with particularity the provision of the 
regulation or proposed order objected to; (4) must specifically state 
each objection on which a hearing is requested; failure to request a 
hearing on an objection constitutes a waiver of the right to a hearing 
on that objection; and (5) must include a detailed description and 
analysis of the factual information to be presented in support of the 
objection if a hearing is requested; failure to include a description 
and analysis for an objection constitutes a waiver of the right to a 
hearing on that objection.
    Following publication of the final rule permitting the irradiation 
of seeds for sprouting to control food-borne pathogens, FDA received 
numerous submissions within the 30-day objection

[[Page 27587]]

period. FDA received a letter from Public Citizen (letter to Docket No. 
4602, November 15, 2000) containing eight numbered objections with a 
request for a hearing on each objection, and a letter by Jonathan 
Sprouts, Inc. (letter to Docket No. 5055, December 19, 2000), 
expressing concern over the labeling of sprouts grown from seeds that 
have been irradiated. The remaining submissions expressed general 
opposition to the final rule. Those submissions are brief form letters 
which state either one or a combination of the following general 
concerns: That no toxicity studies were performed directly on the 
consumable sprouts, that nutrition data was submitted for irradiation 
doses of 6 kGy and not the petitioned maximum of 8 kGy, or that the 
lack of labeling for sprouts grown from irradiated seeds was a concern. 
Those concerns were raised with more specificity by the other two 
submissions and will be addressed as part of the response to those 
submissions in section IV of this document.

III. Standards for Granting a Hearing

    Specific criteria for deciding whether to grant or deny a request 
for a hearing are set out in Sec.  12.24(b). Under that regulation, a 
hearing will be granted if the material submitted by the requester 
shows, among other things, the following: (1) There is a genuine and 
substantial factual issue for resolution at a hearing; a hearing will 
not be granted on issues of policy or law; (2) the factual issue can be 
resolved by available and specifically identified reliable evidence; a 
hearing will not be granted on the basis of mere allegations or denials 
or general descriptions of positions and contentions; (3) the data and 
information submitted, if established at a hearing, would be adequate 
to justify resolution of the factual issue in the way sought by the 
requestor; a hearing will be denied if the data and information 
submitted are insufficient to justify the factual determination urged, 
even if accurate; (4) resolution of the factual issue in the way sought 
by the person is adequate to justify the action requested; a hearing 
will not be granted on factual issues that are not determinative with 
respect to the action requested (e.g., if the action would be the same 
even if the factual issue were resolved in the way sought); (5) the 
action requested is not inconsistent with any provision in the act or 
any FDA regulation; and (6) the requirements in other applicable 
regulations, e.g., 21 CFR 10.20, 12.21, and 12.22, and in the notice 
issuing the final regulation or the notice of opportunity for hearing 
are met.
    A party seeking a hearing is required to meet a ``threshold burden 
of tendering evidence suggesting the need for a hearing'' (Costle v. 
Pacific Legal Foundation, 445 U.S. 198, 214 (1980), reh. denied, 446 
U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc., 
412 U.S. 609, 620-21 (1973)). An allegation that a hearing is necessary 
to ``sharpen the issues'' or to ``fully develop the facts'' does not 
meet this test (Georgia Pacific Corp. v. U.S. EPA, 671 F.2d 1235, 1241 
(9th Cir. 1982)). If a hearing request fails to identify any factual 
evidence that would be the subject of a hearing, there is no point in 
holding one. In judicial proceedings, a court is authorized to issue 
summary judgment without an evidentiary hearing whenever it finds that 
there are no genuine issues of material fact in dispute and a party is 
entitled to judgment as a matter of law (see Rule 56, Federal Rules of 
Civil Procedure). The same principle applies in administrative 
proceedings (see Sec.  12.28).
    A hearing request must not only contain evidence, but that evidence 
should raise a material issue of fact concerning which a meaningful 
hearing might be held (Pineapple Growers Association v. FDA, 673 F.2d 
1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection 
are, even if true, legally insufficient to alter the decision, the 
Agency need not grant a hearing (see Dyestuffs and Chemicals, Inc. v. 
Flemming, 271 F.2d 281, 286 (8th Cir. 1959), cert. denied, 362 U.S. 911 
(1960)). A hearing is justified only if the objections are made in good 
faith and if they ``draw in question in a material way the 
underpinnings of the regulation at issue'' (Pactra Industries v. CPSC, 
555 F.2d 677, 684 (9th Cir. 1977)). A hearing need not be held to 
resolve questions of law or policy (see Citizens for Allegan County, 
Inc. v. FPC, 414 F.2d 1125, 1128 (DC Cir. 1969); Sun Oil Co. v. FPC, 
256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S. 872 (1958)).
    Even if the objections raise material issues of fact, FDA need not 
grant a hearing if those same issues were adequately raised and 
considered in an earlier proceeding. Once an issue has been so raised 
and considered, a party is estopped from raising that same issue in a 
later proceeding without new evidence. The various judicial doctrines 
dealing with finality, such as collateral estoppel, can be validly 
applied to the administrative process (see Pac. Seafarers, Inc. v. Pac. 
Far East Line, Inc., 404 F.2d 804, 809 (DC Cir. 1968), cert. denied, 
393 U.S. 1093 (1969)). In explaining why these principles ought to 
apply to an agency proceeding, the U.S. Court of Appeals for the 
District of Columbia Circuit wrote: ``The underlying concept is as 
simple as this: Justice requires that a party have a fair chance to 
present his position. But overall interests of administration do not 
require or generally contemplate that he will be given more than one 
fair opportunity.'' Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 
316, 322 (DC Cir. 1972; see also Costle v. Pacific Legal Foundation, 
445 U.S. at 215-217.
    In summary, a hearing request must present sufficient credible 
evidence to raise a material issue of fact and the evidence must be 
adequate to resolve the issue as requested and to justify the action 
requested.

IV. Analysis of Objections and Response to Hearing Requests

    The letter from Public Citizen contains eight numbered objections 
and requests a hearing on each of them. Where Public Citizen's 
objections overlap, FDA has combined its response. The letter from 
Jonathan Sprouts, Inc., raised one objection and requested a hearing on 
its objection. FDA addresses each of the objections below, as well as 
the evidence and information filed in support of each, comparing each 
objection and the information submitted in support of it to the 
standards for granting a hearing in Sec.  12.24(b).

A. Application of 100-Fold Safety Factor

    The first objection raised by Public Citizen in response to the 
seeds for sprouting rule contends that the Agency failed to apply a 
100-fold safety factor, as required by Sec.  170.22 (21 CFR 170.22),\1\ 
for the irradiation of seeds for sprouting. While FDA agrees that Sec.  
170.22 states that FDA will use a 100-fold safety factor when applying 
animal data to man, FDA notes that Sec.  170.22 provides for use of a 
different safety factor ``where evidence is submitted which justifies 
use of a different safety factor.''
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    \1\ Section 170.22 states: ``In accordance with section 
409(c)(5)(C) of the Act, the following safety factors will be 
applied in determining whether the proposed use of a food additive 
will be safe: Except where evidence is submitted which justifies use 
of a different safety factor, a safety factor in applying animal 
experimentation data to man of 100 to 1, will be used; that is, a 
food additive for use by man will not be granted a tolerance that 
will exceed 1/100th of the maximum amount demonstrated to be without 
harm to experimental animals.''
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    The Agency has determined that use of a different safety factor is 
appropriate based on the considerable body of data available from 
studies involving irradiated foods fed to laboratory animals and 
reviewed by FDA. FDA's Bureau of Foods Irradiated Foods

[[Page 27588]]

Committee (BFIFC) determined that the studies involving irradiated 
foods that they evaluated did not appear to show adverse effects (Ref. 
1). These studies, taken as a whole, serve as an independent method to 
assess toxicological safety. The studies included in that evaluation 
are those which have been relied on by the Agency in previous 
evaluations of the safety of other irradiated foods, such as lettuce, 
spinach, molluscan shellfish, shell eggs, meat, and poultry (see 73 FR 
49593, August 22, 2008; 70 FR 48057, August 16, 2005; 65 FR 45280, July 
21, 2000; 62 FR 64107, December 3, 1997; 55 FR 18538, May 2, 1990; and 
51 FR 13376, April 18, 1986), and additional data and information from 
FDA files or other published reports regarding studies in which animals 
were fed a wide variety of foods irradiated at different doses.
    The Agency's analysis incorporates the principle that toxicological 
data collected from studies on a given food may be applied to the 
toxicological evaluation of foods of a similar generic class and that 
data from foods irradiated at high doses can be applied to the 
toxicological evaluation of foods of similar generic class receiving 
lower doses (Ref. 2). The Agency's analysis also draws upon the 
integrated toxicological database derived from the extensive body of 
work reviewed by the Agency (see 51 FR 13376 at 13378) and by WHO \2\ 
in previous evaluations of the safety of irradiated foods (Refs. 3 and 
4).
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    \2\ During the early 1980s, a joint Food and Agriculture 
Organization/International Atomic Energy Agency, World Health 
Organization (FAO/IAEA/WHO) Expert Committee evaluated the 
toxicological and microbiological safety and nutritional adequacy of 
irradiated foods. The Expert Committee concluded that irradiation of 
any food commodity at an average dose of up to 10 kGy presents no 
toxicological hazard (Ref. 3). In the 1990s, WHO reanalyzed the 
safety data including additional studies (see 51 FR 13376 at 13378) 
and concluded that the integrated toxicological database is 
sufficiently sensitive to evaluate safety and that no adverse 
toxicological effects due to irradiation were observed in the dose 
ranges tested (Ref. 4).
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    In light of the substantial data and the toxicological assessments 
that have been reviewed by FDA, the Agency concludes that under Sec.  
170.22 the Agency is not required to apply the 100-fold safety factor 
to the use of ionizing radiation for seeds for sprouting. This 
collective information is sufficient to justify the use of a different 
safety factor. Further, the applicability of Sec.  170.22 is a legal 
issue, and a hearing will not be granted on issues of law (Sec.  
12.24(b)(1)).

B. Application of the National Academy of Sciences-National Research 
Council Principles and Procedures

    Public Citizen's second objection asserts that FDA did not follow 
the ``principles and procedures for establishing the safety of food 
additives stated in current publication of the National Academy of 
Sciences-National Research Council,'' as required by Sec.  170.20.
    The Agency has consistently taken the position that many 
scientifically valid types of data may properly support a finding that 
the proposed use of a food additive is safe. The Agency pointed out in 
the molluscan shellfish final rule (70 FR 48057 at 48068) that the 
National Academy of Sciences-National Research Council testing 
standards and guidelines have been stated in relatively general terms 
and that in practice, FDA has applied exposure and toxicological 
criteria that were both current for the time and appropriate for 
assessing the safety of a particular food additive.
    In its objection, Public Citizen asserts that FDA failed to 
properly interpret its own regulation, but has provided no new 
information that would refute the Agency's reasoning. The objection 
implies that the Agency is obligated to explicitly discuss its 
consideration of National Academy of Sciences-National Research Council 
guidelines in its rules, but there is nothing in Sec.  170.20 that 
imposes such an obligation on the Agency. Further, the applicability of 
Sec.  170.20 is a legal issue, and a hearing will not be granted on 
issues of law (Sec.  12.24(b)(1)). Public Citizen has not provided a 
basis for a hearing and FDA is denying their request for a hearing 
based on this objection.

C. Toxicology Issues

    Public Citizen objects to the seeds for sprouting final rule 
because the petitioner, Caudill Seed Co. Inc., submitted, ``[n]o 
conventional animal toxicity studies on sprouts from irradiated 
seeds.'' Additionally, Public Citizen asserts that the references 
contained within FAP 9M4673 ``do not address the potential toxicity of 
irradiated sprouts.''
    The Agency agrees that the petition did not include toxicological 
studies conducted using irradiated sprouts. As noted in the seeds for 
sprouting final rule (65 FR 64605), the Agency has reviewed both the 
data included in its database, as well as the published references, 
submitted by the petitioner, of toxicology studies related to 
irradiated foods. FDA has consistently taken the position that various 
scientifically validated types of data may properly support a safety 
determination for a proposed use of a food additive (see Sec.  170.20). 
In the case of food irradiation, the Agency has taken advantage of the 
extensive research and large body of knowledge, such as the information 
compiled by BFIFC and other studies in FDA's files, concerning the 
principles of radiation chemistry and the chemical composition of 
foods.
    Public Citizen also contends that FDA's statement that the 
``petitioner submitted published articles and other study reports 
containing data and information related to seeds for sprouting * * * in 
the areas of radiation chemistry [and] toxicity'' in the final rule is 
incorrect. Public Citizen's claim is without merit. The petitioner 
provided articles on the toxicity of irradiated foods along with their 
submission, which are listed and summarized in the toxicology 
memorandum (Ref. 5). As previously stated, in reviewing the 
petitioner's application, FDA considered the articles submitted by the 
petitioner in addition to relevant international reports and relevant 
scientific articles in FDA's files (see e.g. Refs. 2, 6, and 7). 
However, FDA does agree that there were no toxicological studies 
conducted using irradiated seeds for sprouting. FDA has consistently 
taken the position that it is unnecessary for a safety analysis to be 
performed involving the specific food to be irradiated. As noted in the 
meat final rule (62 FR 64107 at 64112), the Agency relies on scientific 
studies evaluating the extent to which safety data on an irradiated 
food type can be extrapolated to other food types and the extent to 
which individual studies of irradiated foods can be evaluated as a 
whole (Ref. 4). Thus, data and information derived from studies of 
irradiated foods in general are sufficient to support a determination 
of safety for irradiated seeds for sprouting. Public Citizen's 
suggestion that such information is not sufficient to support a 
determination of safety is unsupported by specific data or other 
factual information.
    Public Citizen failed to include any new information or data that 
would refute the Agency's findings about the toxicity of irradiated 
seeds for sprouting. The request for a hearing merely alleges that 
there is a potential for harm, without providing any evidence that the 
Agency has not considered previously. A hearing will not be granted on 
the basis of mere allegations or general descriptions of positions and 
contentions (Sec.  12.24(b)(2)). The objectors must, at a minimum, 
raise a material issue

[[Page 27589]]

concerning which a meaningful hearing might be held.

D. Radiolysis Products

    Public Citizen alleges that there are unsubstantiated statements 
contained in the review memorandum and final rule regarding radiolytic 
byproducts. There are two parts to this objection; the Agency will 
address each part as follows.
    The first statement to which Public Citizen objects is found in the 
Chemistry Memorandum from K. Morehouse to J. Ziyad dated February 23, 
2000 (Ref. 8), asserting that ``radiolysis products which may have been 
formed by irradiation of the seeds will be `diluted' in the final 
product * * *. Also, it is likely that the water-soluble products will 
be removed by the growth medium.'' Public Citizen claims that this 
statement is unfounded because no data was cited regarding the dilution 
potential of radiolytic byproducts.
    The Agency disagrees that the statement was unsubstantiated. The 
full statement is as follows: ``As the seeds mature and form sprouts, 
radiolysis products which may have been formed by irradiation of the 
seeds will be ``diluted'' in the final product. For example, alfalfa 
seeds contain only 7.4 percent water whereas alfalfa sprouts contain 
88.3 percent water (see Table I of Ref. 8). Also, it is likely that 
water-soluble products will be removed by the growth medium.''
    ``Table I,'' referred to in the previous quotation, contains the 
nutrient composition for alfalfa seeds and raw alfalfa sprouts. This 
data was obtained from a published study which determined the nutrient 
content of various seeds and sprouts (Ref. 9). It is apparent from the 
data supplied that as the seeds sprout to the final product, they 
absorb water, in the case of alfalfa sprouts the water content 
increases from 7.4 percent to 88.3 percent. It follows that any 
byproducts would be diluted by the absorption of water, which is the 
growth medium for sprouts. The same study asserts that it is possible 
for sugars to leach into the growth medium during the sprouting 
procedure; therefore, it is likely that other water-soluble products 
could also be removed by the growth medium. Furthermore, Public Citizen 
did not provide any information related to the safety of irradiated 
seeds for sprouting that the Agency had not considered, and the 
objection contains no information that would cause the Agency to change 
its safety determination. An objector must make an adequate proffer of 
evidence to support its allegations and to show that they provide a 
basis on which to call into question the Agencies conclusions (Sec.  
12.24(b)(2)). Public Citizen has not provided a basis for a hearing, 
and FDA is denying Public Citizen's request for a hearing based on this 
objection.
    Public Citizen also objects to the Agency's conclusion that because 
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 the 
chemical compositions of sprouts grown from irradiated seeds will not 
differ in any significant manner from sprouts grown from seeds that 
have not been irradiated. Public Citizen feels that these statements 
are unsupported and is requesting a hearing based on this matter.
    FDA disagrees with the allegation that the statements made in the 
final seed for sprouting rule (65 FR 64605) are unsupported. Through 
information compiled by FDA and the materials submitted with each food 
additive petition involving irradiation (see e.g., section IV.A of this 
document), FDA has established that the effect ionizing radiation has 
on the characteristics of foods are a direct result of the chemical 
reactions induced by the absorbed radiation. This large body of data 
includes studies regarding the effects of ionizing radiation on 
different foods under various conditions of irradiation allowing FDA to 
extrapolate data obtained from one food to other foods (for more 
information see 73 FR 49593 at 49594 and 70 FR 48057 at 48059). 
Research has established that the types and amounts of products 
generated depend on the chemical constituents of the food and the 
conditions of radiation (Refs. 6, 7, and10). See the final rule 
permitting the irradiation of meat (62 FR 64107) for a more in depth 
discussion of radiation chemistry, nutrition, toxicology, and 
microbiology related to irradiation of foods under various conditions 
of use. Additionally, the review memorandum and the evidence reviewed 
and discussed therein, support the statement that radiolytic byproducts 
would be formed in low amounts in seeds for sprouting (Ref. 8). The 
Agency also notes that ionizing radiation causes fewer chemical changes 
in dry material (i.e. the seeds for sprouting) than in fresh fruits and 
vegetables due to the increased water content of the fresh items (Ref. 
6).
    Public Citizen's assertion provides no basis to challenge FDA's 
assessment of the safety of irradiated seeds for sprouting. A hearing 
will not be granted on the basis of mere allegations or general 
descriptions of positions and contentions (Sec.  12.24(b)(2)). The 
objector must, at a minimum, raise a material issue concerning which a 
meaningful hearing might be held. Public Citizen has not provided a 
basis for a hearing; therefore, FDA is denying their request for a 
hearing based on this objection.

E. Nutritional Considerations

    In its request for a hearing, Public Citizen questions the 
nutritional adequacy of the irradiated seeds for sprouting and cites an 
FDA toxicology review memorandum (Ref. 5) in which the reviewer 
describes the data submitted by the petitioner as ``crude'' and notes a 
discrepancy between laboratory assessments in the vitamin A content of 
sprouts grown from irradiated seeds. Moreover, Public Citizen objects 
to the final rule on the grounds that nutritional assessments were 
conducted on sprouts grown from seeds that were irradiated at 6 kGy, 
rather than the petitioned maximum of 8 kGy.
    As noted in the final rule, there were no relevant losses in the 
vitamin A content when comparing the sprouts grown from irradiated 
seeds to the control sprouts, which were grown from non-irradiated 
seeds. Rather, the vitamin A content was higher in all instances 
comparing the sprouts grown from irradiated seeds to the control seeds 
(65 FR 64605). The final rule also indicated that any vitamin loss that 
occurs in sprouts grown from irradiated seeds is expected to be 
inconsequential when compared to the total dietary nutrient consumption 
(Ref. 5).
    In response to Public Citizen's objection based on the studies 
conducted at 6 kGy as opposed to 8 kGy, the Agency notes that there 
were no nutritional losses associated with sprouts grown from seeds 
irradiated at 6 kGy. Changes in the level of vitamins associated with 
irradiation are gradual with each increasing dose; scientific evidence 
does not support a threshold effect above which significant losses 
would occur (Ref. 6). Therefore, it is reasonable to anticipate that 
sprouts grown from seeds irradiated at 8 kGy would not lead to 
nutritionally relevant losses either. Furthermore, the Codex 
Alimentarius Commission (Codex) published its standard for irradiated 
foods in 1983 for adoption by Codex member countries (Ref. 11). This 
standard was based on the conclusion that the irradiation of any food 
commodity at an overall average dose of up to 10 kGy presents no 
concerns (Ref. 3). The Codex standard was revised in

[[Page 27590]]

2003,\3\ at which time Codex integrated the joint FAO/IAEA/WHO study 
group conclusion that food irradiated to any dose appropriate to 
achieve the intended technological effect is both safe to consume and 
nutritionally adequate (i.e. at doses up to and above 10 kGy) (Ref. 
12).
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    \3\ It should be noted that the revisions of the Codex standards 
in 2003 do not impact this rulemaking.
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    Overall, Public Citizen's request for a hearing suggests that there 
is potential for harm from possible nutritional losses from the 
irradiation of seeds for sprouting, without providing any evidence to 
support this suggestion. An objector must make an adequate proffer of 
evidence to support its allegations and to show that they provide a 
basis on which to call into question the Agency's conclusions. A 
hearing will be denied if the Commissioner of Food and Drugs concludes 
that the data and information submitted are insufficient to justify the 
factual determination urged, even if accurate (Sec.  12.24(b)(3)). 
Public Citizen does not submit or otherwise identify any factual data 
that would cause the Agency to alter its conclusions about the 
nutritional changes in irradiated seeds. Therefore, FDA is denying the 
request for a hearing based on this objection.

F. Labeling Concerns

    The final objection to the seeds for sprouting rule was submitted 
by Jonathan Sprouts, Inc, objecting to the lack of a requirement that 
sprouts grown from seeds that have been irradiated be labeled as 
treated by irradiation. Some of the general objections FDA received to 
the seeds for sprouting final rule also raised this point. Most of 
these objections were brief and expressed general dissatisfaction 
regarding FDA's decision on labeling, but did not provide any 
substantive data or information. Jonathan Sprouts, Inc., claimed that 
there are morphological differences between sprouts grown from 
irradiated versus non-irradiated seeds, which, they claim, support the 
need for labeling sprouts grown from seeds that have been irradiated; 
however, they failed to provide any additional data or information to 
substantiate their claim.
    The Agency specifically discussed in the seeds for sprouting rule 
the labeling of irradiated seeds for sprouting and sprouts grown from 
such seeds (65 FR 64605 at 64606). The FDA evaluated the need for 
special labeling against the labeling provisions for food treated by 
ionizing radiation in Sec.  179.26(c) (21 CFR 179.26(c)). Specifically, 
Sec.  179.26(c) states that ``the label and labeling of retail packages 
of foods irradiated * * * shall bear the * * * logo along with either 
the statement `Treated with radiation' or * * * `Treated by 
irradiation.''' (emphasis added). Thus, the requirement applies only to 
the food that has been irradiated. It was noted in the seeds for 
sprouting rule that the irradiated article, the unsprouted seed, is not 
what is generally consumed and that the nutritional and flavor 
characteristics of the sprouts is based upon the fact that the 
irradiated seeds were grown into sprouts; therefore, sprouts grown from 
irradiated seeds do not require labeling as they are not the food that 
is being irradiated.
    Additionally, neither Jonathan Sprouts, Inc., nor any of the other 
objectors that raised this point, provided any evidence that sprouts 
grown from irradiated seeds differ from sprouts grown from seeds that 
were not irradiated. An objector must make an adequate proffer of 
evidence to support its allegations and to show that they provide a 
basis on which to call into question the Agency's conclusions (Sec.  
12.24(b)(2)). Therefore, the Agency is denying Jonathan Sprouts' 
objection.

V. Summary and Conclusion

    Section 409 of the Federal Food, Drug and Cosmetic Act requires 
that a food additive be shown to be safe prior to marketing. Under 
Sec.  170.3(i), a food additive is ``safe'' if ``there is a reasonable 
certainty in the minds of competent scientists that the substance is 
not harmful under the intended conditions of use.'' In the Agency's 
October 30, 2000, seeds for sprouting rule, FDA concluded that the 
studies conducted, based on its evaluation of the data submitted in the 
petition and other relevant material, that this use of irradiation is 
safe for its intended use in seeds for sprouting.
    The petitioner has the burden to demonstrate the safety of the 
additive to gain FDA approval. However, once FDA makes a finding of 
safety in an approval document, the burden shifts to an objector, who 
must come forward with evidence that calls into question FDA's 
conclusion (see section 409(f)(1) of the Federal Food, Drug, and 
Cosmetic Act).
    Despite their allegations, neither Public Citizen nor Jonathan 
Sprouts, Inc., has established that FDA overlooked significant 
information contained within the record in reaching its conclusion that 
the use of irradiation for microbial control of pathogens in seeds for 
sprouting is safe. In such circumstances, FDA has determined that the 
objections do not raise any genuine and substantial issue of fact that 
can be resolved by an evidentiary hearing (Sec.  12.24(b)). 
Accordingly, FDA is denying the requests for a hearing.

VI. References

    The following references are on display in the Division of Dockets 
Management (HFA-303) Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20857, under Docket No. FDA-1999-F-0021 
(formerly 1999F-2673) and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday.

1. Memorandum to file, FAP 4M4428, from David G. Hattan, Acting 
Director, Division of Health Effects Evaluation, dated November 20, 
1997.
2. Taub, I.A. et al., ``Factors Affecting Radiolytic Effects In 
Food,'' Radiation Physics and Chemistry, 14:639-653, 1979.
3. WHO, ``Wholesomeness of Irradiated Food: Report of a Joint FAO/
IAEA/WHO Expert Committee,'' World Health Organization Technical 
Report Series, No. 659, World Health Organization, Geneva, 1981.
4. WHO, ``Safety and Nutritional Adequacy of Irradiated Food,'' 
World Health Organization, Geneva, 1994.
5. Memorandum to the file, FAP 9M4673, from I. Chen, FDA, to J. 
Ziyad, FDA, dated February 28, 2000.
6. Diehl, J.F., ``Safety of Irradiated Foods,'' 2nd Edition, Marcel 
Dekker, New York, 1995.
7. Merritt, C., Jr., ``Qualitative and Quantitative Aspects of Trace 
Volatile Components in Irradiated Foods and Food Substances,'' 
Radiation Research Reviews, 3:353-368, 1972.
8. Memorandum to the file, FAP 9M4673, from K. Morehouse, FDA, to J. 
Ziyad, FDA, dated February 23, 2000.
9. Kylen, A.M. and R.M. McCready, ``Nutrients in Seeds and Sprouts 
of Alfalfa, Lentils, Mung Beans and Soybeans,'' Journal of Food 
Science, 40:1008-1009, 1975.
10. Diehl, J.F., ``Radiolytic Effects in Foods,'' pp. 279-357, in 
Preservation of Food by Ionizing Radiation, vol. I, E.S. Josephson 
and M.S. Peterson, eds., CRC Press, Boca Raton, FL, 1982.
11. Codex 1983, ``Codex General Standard for Irradiated Foods (CODEX 
STAN 106-1983)'' Codex Alimentarius Commission, Food and Agriculture 
Organization and World Health Organization, Rome, 1983.
12. WHO, ``High-Dose Irradiation: Wholesomeness of Food Irradiated 
With Doses Above 10 kGy,'' World Health Organization Technical 
Report Series, No. 890, World Health Organization, Geneva, 1999.

    Dated: May 1, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11391 Filed 5-10-12; 8:45 am]
BILLING CODE 4160-01-P