[Federal Register: April 9, 2007 (Volume 72, Number 67)]
[Rules and Regulations]
[Page 17394-17397]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09ap07-9]
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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
[[Page 17397]]
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