[Federal Register Volume 72, Number 67 (Monday, April 9, 2007)]
[Rules and Regulations]
[Pages 17394-17397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-6646]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 2003F-0088 (formerly 03F-0088)]


Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

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

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SUMMARY: The Food and Drug Administration (FDA) is responding to 
objections and is denying requests that it has received for a hearing 
on the final rule that amended the food additive regulations by 
establishing a new maximum permitted energy level of x-rays for 
treating food of 7.5 million electron volts (MeV) provided that the x-
rays are generated from machine sources that use tantalum or gold as 
the target material, with no change in the maximum permitted dose 
levels or uses currently permitted by FDA's food additive regulations. 
After reviewing the objections to the final rule and the requests for a 
hearing, the agency has concluded that the objections do not raise 
issues of material fact that justify a hearing or otherwise provide a 
basis for removing the amendment to the regulation.

FOR FURTHER INFORMATION CONTACT: Andrew J. Zajac, Center for Food 
Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1267.

SUPPLEMENTARY INFORMATION:

I. Introduction

    FDA published a notice in the Federal Register of March 13, 2003 
(68 FR 12087), announcing the filing of food additive petition, FAP 
3M4745, by Ion Beam Applications to amend the food additive regulations 
in Sec.  179.26 Ionizing radiation for the treatment of food (21 CFR 
179.26) by increasing the maximum permitted energy level of x-rays for 
treating food from 5 to 7.5 MeV. The rights to this petition were 
subsequently transferred to Sterigenics International, Inc. In response 
to this petition, FDA issued a final rule in the Federal Register of 
December 23, 2004 (69 FR 76844) permitting the safe use of 7.5 MeV x-
rays for treating food provided that the x-rays are generated from 
machine sources that use tantalum or gold as the target material, with 
no change in the maximum permitted dose levels or uses currently 
permitted by FDA's food additive regulations (the 7.5 MeV x-ray final 
rule). 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 January 24, 2005).

II. Objections and Requests for a Hearing

    Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(f)) 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 therefore, and requesting a public hearing 
upon such objections.'' FDA may deny a hearing request if the 
objections to the regulation do not raise genuine and substantial 
issues of fact that can be resolved at a hearing (Community Nutrition 
Institute v. Young, 773 F.2d 1356, 1364 (D.C. Cir. 1985), cert. denied, 
475 U.S. 1123 (1986)).
    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 7.5 MeV x-ray final rule, FDA received 
about 100 objections within the 30-day objection period. All but one of 
these submissions expressed general opposition to increasing the 
maximum permitted energy level of x-rays used to irradiate food and to 
food irradiation. Most of these objections were form letters, 
identically worded, urging FDA to conduct additional studies on the 
effects of 7.5 MeV x-rays on food and objecting ``to the agency's 
decision knowing that some amount of radioactivity could be created in 
food treated with 7.5 MeV.'' While most of these objections requested a 
hearing, no evidence was submitted in support of these objections that 
could be considered in an evidentiary hearing. These submissions 
expressing general opposition raise no factual issue for resolution 
and, therefore, do not justify a hearing.\1\ The one submission raising 
specific objections was a letter from Public Citizen with six 
objections to the 7.5 MeV x-ray final rule. The letter requested a 
hearing on issues raised by each objection. These objections are 
addressed in section IV of this document.
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    \1\A large number of these form letters were submitted after the 
close of the objection period. Tardy objections fail to satisfy the 
requirements of 21 U.S.C. 348(f)(1) and need not be considered by 
the agency (ICMAD v. HEW, 574 F.2d 553, 558 n.8 (D.C. Cir), cert. 
denied, 439 U.S. 893 (1978)).
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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

[[Page 17395]]

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, Sec. Sec.  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, 214-215 (1980), reh. denied, 
446 U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, 
Inc., 412 U.S. 609, 620-621 (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. 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 Ass'n 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 (8th Cir. 1959), cert. denied, 362 U.S. 911 
(1960)). FDA need not grant a hearing in each case where an objector 
submits additional information or posits a novel interpretation of 
existing information (see United States v. Consolidated Mines & 
Smelting Co., 455 F.2d 432 (9th Cir. 1971)). In other words, 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 (9th 
Cir. 1977)). Finally, courts have uniformly recognized that 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 (D.C. 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 can be validly applied to the administrative 
process. In explaining why these principles ``self evidently'' 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 a fair 
opportunity.'' Retail Clerks Union, Local 1401 v. NLRB, 463 F.2d 316, 
322 (D.C. Cir. 1972). (See Costle v. Pacific Legal Foundation, supra at 
215-220. See also Pacific Seafarers, Inc. v. Pacific Far East Line, 
Inc., 404 F.2d 804 (D.C. Cir. 1968), cert. denied, 393 U.S. 1093 
(1969).))
    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 raises six issues that they believe 
to be factual and requests a hearing based on these objections. FDA 
addresses each of the objections in the following paragraphs, 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.
    (1) Public Citizen contends that FDA did not adequately account for 
the fact that an electron beam on an x-ray target is not monoenergetic, 
and that a significant portion of the beam may be higher than the 
nominal energy, resulting in higher neutron production in the food and 
more activity. Public Citizen cites a published paper in the petition 
in which the authors note that measurements and calculations of a 7.5 
MeV setting actually correspond to 8.1 MeV 0.8 MeV.
    The objection does not raise a genuine and substantial issue of 
fact for resolution at a hearing. Contrary to the objection, the final 
rule does not set a ``nominal energy'' limit. The final rule sets out 
7.5 MeV as the maximum energy permitted. X-rays from machine sources at 
energies exceeding 7.5 MeV are not permitted by the final rule.
    Further, the objection provides no evidence to support the 
contention that safety concerns regarding inherent limitations on the 
precision of setting and measuring voltage were not considered. The 
paper referred to in the objection, Gregoire, O., Cleland, M.L., 
Wakeford, Mittendorfer, et al., ``Radiological Safety of Food 
Irradiation With High Energy X-Rays: Theoretical Expectations and 
Experimental Evidence,'' 2002, was included as a reference in the final 
rule and counters the objection. The paper discusses the radiological 
implications of irradiating meat with 7.5 MeV x-rays to an x-ray dose 
of 15 kGy, which is more than twice the maximum dose allowed for meat 
irradiation (4.5 kGy maximum for refrigerated meat and 7.0 kGy maximum 
for frozen meat) (see Sec.  179.26(b)). Experiments were performed with 
x-ray machines that use two different types of electron accelerators, 
one delivering electrons with a narrow electron energy spread, the 
other delivering a broad energy spread. The Gregoire paper concluded 
that risk to individuals from intake of food irradiated with x-rays 
from 7.5 MeV electrons, even with a broad energy spread, would be 
trivial.
    In the experiments discussed in the Gregoire paper, the equipment 
was set to achieve a voltage of 7.5 MeV. Measurements (including 
calculations) to verify the precision of the settings estimated that 
the machine produced electrons at an energy of approximately 8.1 MeV, 
with an uncertainty margin of 0.8 MeV. In other words, within the 
limits of precision of the measurements, the energy of the electrons 
used to produce the x-rays was shown to be greater than 7.3 MeV but 
less than 8.9 MeV. FDA notes that even though the equipment in this 
experiment produced a higher energy level than permitted by the 
regulation, the results show that any radioactivity that might be 
induced at that higher energy level is trivially small.
    Public Citizen has not raised a genuine and substantial issue of 
fact and

[[Page 17396]]

has not provided any information that contradicts the agency's safety 
determination. Thus, a hearing is not justified based on this objection 
(Sec.  12.24(b)(1) and (2)).
    (2) Public Citizen claims that FDA has concluded that any induced 
activity in food from treating it with 7.5 MeV x-rays is safe without a 
standard for a ``safe'' level of induced activity in food and further 
objects to any additional radiation level in treated food.
    The objection does not cite any support for its contention that FDA 
must establish a general standard for a safe level of induced activity 
in food beyond the act's requirements for food additive approvals. The 
use of x-rays to treat food is a food additive under the act's 
definition of ``food additive,'' which includes any source of radiation 
intended for use in producing, manufacturing, packing, processing, 
preparing, treating, packaging, transporting, or holding food (section 
201(s) of the act) (21 U.S.C. 321(s)). Section 409 of the act requires 
that a regulation approving a food additive must prescribe, with 
respect to the proposed uses of the additive, the conditions under 
which the additive may be safely used. Further, section 409 of the act 
sets out that no such regulation can issue if a fair evaluation of the 
data fails to establish that the proposed use of the food additive, 
under the conditions of use to be specified in the regulation, will be 
safe. FDA has defined ``safe'' and ``safety'' by regulation to mean 
that ``there is a reasonable certainty in the minds of competent 
scientists that the substance is not harmful under the intended 
conditions of use.'' (21 CFR 170.3(i)).
    In accordance with the requirements of section 409 of the act and 
the food additive regulations, FDA determined that food treated with 
7.5 MeV x-rays is safe by comparing the total annual dose from eating 
irradiated foods with the annual dose from naturally occurring 
radionuclides in the food. FDA's determination was based on its review 
of the data in the record, including the reports referenced in the 
final rule from the International Atomic Energy Agency, Gregoire et 
al., and the independent evaluation of the data by Oak Ridge National 
Laboratory. FDA concluded based on these analyses that any 
radioactivity that may be induced in any food treated with 7.5 MeV x-
rays will be trivially low and that any potential human exposure due to 
consumption of irradiated food will be inconsequential compared to that 
from radionuclides that are present naturally in food.
    Public Citizen's objection presents no factual evidence that FDA 
has overlooked in reaching the decision that 7.5 MeV x-rays are safe 
for treating food under the conditions of use specified in the 
regulation. Thus, Public Citizen has failed to justify a hearing on 
this issue (Sec.  12.24(b)(2)).
    (3) Public Citizen objects to the agency's approval of 7.5 MeV x-
rays for treating food without assessing the risk of getting cancer 
from eating food with added radioactivity. The objection points to a 
paper by Ari Brynjolfsson, cited by the petitioner, which estimates the 
lifetime cancer risk from eating foods irradiated with 7.5 MeV x-rays 
to be 0.8 per million.\2\
    FDA disagrees with Public Citizen's assertion that it did not 
consider the risk of getting cancer from eating food treated with 7.5 
MeV x-rays during its review of FAP 3M4745. As stated in the preamble 
of the rule, FDA contracted with Oak Ridge National Laboratory (ORNL) 
to perform an independent evaluation of the data in the administrative 
record, including an evaluation of cancer risk. The ORNL evaluation was 
placed in the docket when the rule published. ORNL concluded that 
because the factors used in the data in the administrative record to 
estimate cancer risk are based on much higher doses than permitted in 
the rule, the data in the administrative record, including the data in 
the Brynjolfsson paper, cannot be applied with any credibility to 
extrapolate cancer risk to the extremely low potential doses that a 
person might receive from consuming food treated with 7.5 MeV x-rays. 
The extrapolations that would be required would yield estimated risks 
far too small to reliably measure or verify. FDA agrees with this 
conclusion.
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    \2\ Public Citizen incorrectly states in their objection that 
the cancer risk estimated by the author is 0.08 per million.
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    The only evidence referenced by Public Citizen in support of its 
assertion is the Brynjolfsson paper, which was part of the 
administrative record and was considered in ORNL's evaluation of the 
data and FDA's safety determination. Therefore, Public Citizen has not 
identified any evidence to support its assertion that was not already 
considered by FDA in its safety determination. A hearing will not be 
granted on the basis of mere allegations or denials or general 
descriptions of positions and contentions (21 CFR 12.24(b)(2)).
    (4) Public Citizen asserts that FDA did not comply with Sec.  
170.22 (21 CFR 170.22), which states that a food additive will not be 
granted a tolerance that will exceed 1/100th of the maximum amount 
demonstrated to be without harm to experimental animals unless evidence 
is submitted which justifies use of a different safety factor. Public 
Citizen expresses the view that this non-compliance includes not only 
the failure to conduct any animal experiments using foods irradiated 
with 7.5 MeV x-rays, but also the failure to calculate a 100-to-1 
safety factor or submit evidence that justifies the use of a different 
safety factor.
    The objection does not include any evidence or support for the 
contention that animal experiments are required to be conducted to 
determine whether a proposed use of a food additive is safe. The safety 
criteria that must be considered by the agency before a food additive 
regulation is issued are listed in 21 U.S.C. 348(c)(5). The act does 
not prescribe what safety tests should be performed to determine 
whether an additive is safe. Public Citizen's objection references the 
regulation in Sec.  170.22 which sets out a safety factor of 100-to-1 
in applying animal experimentation data to man (that is, the additive 
will not be approved for use in an amount greater than 1/100th of the 
maximum amount demonstrated to be without harm to experimental 
animals), unless evidence is submitted which justifies use of a 
difference safety factor. That regulation concerns how to apply animal 
experimentation data when it exists. It does not, however, require that 
animal testing be done in all food additive safety determinations.
    Because of the extremely low levels of induced radioactivity in 
food from the use of 7.5 MeV x-rays, it would not be possible to 
measure any toxicological effects from this induced activity in food 
fed to animals even with the most sensitive toxicological testing. 
Consequently, animal testing is neither necessary nor helpful to 
demonstrate the safety of food treated with 7.5 MeV x-rays. Rather, 
safety was demonstrated by showing that calculated estimates of 
radiation exposure from induced activity in food from the use of 7.5 
MeV x-rays is far below the exposure from activity resulting from 
radionuclides that are present naturally in food. FDA concluded that 
such an analysis provides information that is far more sensitive to 
potential effects than can be obtained from the use of animal studies. 
Public Citizen has submitted no information to establish that the 
animal and other testing it recommended is required to demonstrate 
safety, or even that such testing would be valid to assess safety. 
Because Public Citizen provided no evidence to consider in

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support of its assertion, FDA is denying the request for a hearing on 
this point because a hearing will not be granted on the basis of mere 
allegations or denials or general descriptions of positions and 
contentions (21 CFR 12.24(b)(2)).
    (5) Public Citizen asserts that by FDA failing to comply with Sec.  
170.22, FDA did not comply with Sec.  170.20 (21 CFR 170.20), which 
states that ``the Commissioner will be guided by the principles and 
procedures for establishing the safety of food additives stated in 
current publications of the National Academy of Sciences National 
Research Council.''
    Section 170.22 pertains to safety factors to be applied to animal 
experimentation data in determining whether a proposed use of a food 
additive is safe. As discussed previously in item 4, no animal studies 
were necessary nor were any conducted to demonstrate that the use of 
7.5 MeV x-rays is safe for treating food. Because the provisions of 
Sec.  170.22 do not apply to the agency's review of FAP 3M4745, Public 
Citizen's assertion that FDA did not comply with Sec.  170.20 because 
it did not comply with Sec.  170.22 is without merit. Therefore, this 
objection is not a basis for a hearing because there is no genuine and 
substantial issue of fact for resolution (Sec.  12.24(b)(1)).
    (6) Public Citizen asserts that FDA did not comply with 21 U.S.C. 
348(c)(3)(A), which states that ``No such regulation shall issue if a 
fair evaluation of the data before the Secretary--(A) fails to 
establish that the proposed use of the food additive, under the 
conditions of use to be specified in the regulation, will be safe: 
Provided, That no additive shall be deemed to be safe if it is found to 
induce cancer when ingested by man.'' Nor has FDA complied with Sec.  
170.3(i), which defines ``safe'' as ``there is a reasonable certainty 
in the minds of competent scientists that the substance is not harmful 
under the intended conditions of use.''
    Public Citizen has not provided any evidence to support these 
allegations or that contradicts or challenges the agency's safety 
determination. The agency finds that this objection is merely a general 
description of Public Citizen's position, and that it does not raise a 
factual issue for resolution at a hearing. Therefore, FDA is denying 
the requests for a hearing on this point because there is no genuine 
and substantial issue of fact for resolution at a hearing, and a 
hearing will not be granted on the basis of mere allegations or denials 
or general descriptions of positions and contentions (Sec.  12.24(b)(1) 
and (b)(2)).

V. Summary and Conclusions

    Section 409 of the 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 final rule approving the use of 7.5 MeV x-
rays for treating food, FDA concluded, based on its evaluation of the 
data submitted in the petition and other relevant material, that the 
use of 7.5 MeV x-rays proposed in the petition for treating food is 
safe under the conditions set forth in the regulation codified at Sec.  
179.26. The petitioner has the burden to demonstrate the safety of the 
additive in order to gain FDA approval. Once FDA makes a finding of 
safety, the burden shifts to an objector, who must come forward with 
evidence that calls into question FDA's conclusion (American Cyanamid 
Co. v. FDA, 606 F.2d 1307, 1314-1315 (D.C. Cir. 1979)).
    None of the objections received contained evidence to support a 
genuine and substantial issue of fact. Nor has any objector established 
that the agency overlooked significant information in reaching its 
conclusion. Therefore, the agency has determined that the objections 
that requested a hearing do not raise any substantial issue of fact 
that would justify an evidentiary hearing (Sec.  12.24(b)). 
Accordingly, FDA is not making any changes in response to the 
objections and is denying the requests for a hearing.

    Dated: March 27, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-6646 Filed 4-6-07; 8:45 am]
BILLING CODE 4160-01-S