[Federal Register Volume 77, Number 92 (Friday, May 11, 2012)]
[Rules and Regulations]
[Pages 27586-27590]
From the Federal Register Online via the Government Publishing 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.
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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