[Federal Register Volume 72, Number 138 (Thursday, July 19, 2007)]
[Rules and Regulations]
[Pages 39557-39560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-13947]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 1994F-0008 (formerly Docket No. 94F-0008)]


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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is responding to 
objections and is denying the requests that it has received for a 
hearing on the final rule that amended the food additive regulations to 
authorize the use of a machine source of high energy x-rays to inspect 
cargo containers that may contain food. 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 revoking or 
modifying 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

    In the Federal Register of February 24, 1994 (59 FR 8995), FDA 
published a notice announcing the filing of a petition (FAP 4M4407) 
submitted by Analytical Systems Engineering Corp. (ASEC) (now ACS 
Defense, Inc.) to amend the food additive regulations in Sec.  179.21 
Sources of radiation used for inspection of food, for inspection of 
packaged food, and for controlling food processing (21 CFR 179.21) to 
provide for the safe use of machine sources of high energy x-rays to 
inspect cargo containers that may contain food. The rights to the 
petition were subsequently transferred to R. F. Reiter and Associates. 
In response to the petition, FDA issued a final rule in the Federal 
Register of April 10, 2001 (66 FR 18537), permitting the use of x-rays 
produced by machine sources of 10 million electron volts (MeV) or lower 
to inspect food, providing that no food receives a dose in excess of 
0.5 gray (Gy). This rule will be referred to in this document as the 
``cargo inspection 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 May 10, 2001).

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 therefor, 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 cargo inspection final rule, FDA 
received a letter from Public Citizen within the 30-day objection 
period. Public Citizen sought revocation of the final rule based on 
three objections and requested a hearing on issues raised by each 
objection.

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, Sec. Sec.  12.21 and 12.22, and in the 
notice issuing the final requlation or

[[Page 39558]]

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 objections to the cargo inspection final rule pertain to FDA's 
safety determination. FDA addresses each of the objections below, as 
well as the data 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.

A. Safety of Irradiation for Inspection of Cargo Containers

    Under 21 CFR 170.3(i), safety of a food additive means that there 
is a reasonable certainty in the minds of competent scientists that the 
substance is not harmful under the intended conditions of use. FDA's 
regulations reflect the congressional judgment that the additive must 
be properly tested and such tests carefully evaluated, but that the 
additive need not, indeed cannot, be shown to be safe to an absolute 
certainty. The House Report on the Food Additives Amendment of 1958 
stated: ``Safety requires proof of a reasonable certainty that no harm 
will result from the proposed use of the additive. It does not--and 
cannot--require proof beyond any possible doubt that no harm will 
result under any conceivable circumstance'' (H. Rept. 2284, 85th Cong., 
2d sess., 1958).
    The cargo inspection final rule discussed in detail FDA's 
evaluation of the safety of radiation for inspection of cargo 
containers that may contain food (66 FR 18537). Under that regulation, 
machine sources producing x-rays at energies no greater than 10 MeV may 
be used to inspect containers of food, provided that the absorbed dose 
not exceed 0.5 Gy.
    Among the reports submitted in the petition or that FDA identified 
in scientific publications, the agency explicitly cited three in its 
final rule. These reports, which were among the most recent studies or 
reviews, assessed the potential for induced radioactivity in food by 
experimental measurement and theoretical calculation, and provided the 
primary basis for FDA's conclusion regarding safety of the petitioned 
use of 10 MeV x-rays at a dose not to exceed 0.5 Gy.
    One of the reports is from the World Health Organization (WHO). 
This WHO report concluded that no detectable radioactivity will be 
induced in foodstuffs by x-rays with a maximum energy level of 10 MeV 
when a radiation dose of 0.5 Gy is not exceeded.
    The second report (Wakeford and Blackburn, 1991) discussed a study 
investigating the radioactivity induced in codfish, rice, and a 
macerated meat product irradiated with high energy bremsstrahlung\1\ x-
rays produced by an electron linear accelerator that generated 
electrons at energies up to 12 MeV and predominantly at 8 MeV. The 
authors reported that the bremsstrahlung x-rays used to irradiate the 
food had a maximum energy in the region of 10 MeV. These foods received 
radiation doses ranging from 8.8 to 14 kilogray (kGy), which is 17,600 
to 28,000 times higher than the 0.5 Gy maximum dose permitted by the 
final rule. Induced activities in the foods from the bremsstrahlung x-
rays were reported to be extremely small and of the same order as 
natural background levels, and any induced activities dropped quickly.
---------------------------------------------------------------------------

    \1\Bremsstrahlung refers to the type of x-rays that are emitted 
when high-speed electrons are suddenly decelerated due to 
interactions with atomic nuclei. X-rays also can be produced when 
accelerated electrons have sufficient energy to eject electrons from 
the inner shells of atoms. As outer-shell electrons move in to fill 
the vacancies in the lower energy level, x-rays are emitted, called 
characteristic x-rays.
---------------------------------------------------------------------------

    The third report (Findlay et al., 1992) summarized a study that 
investigated the induced radioactivity in chicken, prawns, cheeses, and 
spices irradiated with electron beams at two energies, 10 MeV and 20 
MeV and at different doses up to 10 kGy. The authors noted that any 
induced radioactivity was due to photonuclear reactions resulting from 
bremsstrahlung x-rays and electronuclear reactions induced by the 
electron beams. The authors found that even when the food was 
irradiated with

[[Page 39559]]

electrons at 20 MeV and doses at 10 kGy, the highest energy and dose 
tested, any induced activity was negligible after 1 day.\2\ The authors 
reported that the measured values agreed well with calculated values. 
Based on the totality of the data and other relevant material evaluated 
by FDA, the agency concluded that no detectable radioactivity will be 
induced in food when an x-ray energy of 10 MeV and a dose of 0.5 Gy are 
not exceeded, and that the use of x-rays, produced by a machine source 
at energies of 10 MeV or lower, to inspect food, is safe.
---------------------------------------------------------------------------

    \2\ The authors reported a specific activity after 1 day of 0.01 
becquerel/gram.
---------------------------------------------------------------------------

B. Objections

    Public Citizen contends that FDA has failed to demonstrate that the 
use of the subject additive is safe and gives three reasons for 
objecting to the final rule. Public Citizen requests a public hearing 
on their objections.
    First, Public Citizen contends that FDA's use of the conclusion in 
the WHO report that ``no detectable radioactivity will be induced in 
foodstuffs when an x-ray energy level of 10 MeV and a dose of 0.5 Gy 
are not exceeded'' is flawed because the conclusion is based on an 
extrapolation of theoretical and experimental studies that the report 
does not reference.
    The WHO report states that ``* * * relevant experimental data are 
available from studies designed to evaluate the use of activation 
analysis and the application of x-rays and electrons in food 
irradiation and medical uses at energy levels up to 24 MeV and at doses 
up to 50 kGy. Such studies, both theoretical and experimental, can be 
used to extrapolate downwards to a lower dose such as the 0.5 Gy 
considered for surveillance systems and that these studies show no 
evidence that detectable levels of radioactivity would be induced at 
these lower doses.'' Although not specifically cited, it is clear that 
the experimental data referred to in the report are the data from 
studies that were discussed in several working papers that were 
presented to the WHO consultation group and several relevant published 
papers referenced in the WHO report. These working papers were included 
in the petition along with the WHO report. For example, one paper that 
discussed experimental and theoretical work concerning the possible 
induction of radionuclides in food by high energy x-ray systems used 
for cargo surveillance referenced several relevant studies, including 
one by Glass and Smith.\3\ This particular study, which was submitted 
with the petition, examined isomer radioactivities in elements and food 
using a variety of radiation sources, including 4-24 MeV x-ray sources 
at doses up to 50 kGy. FDA is denying the request for a hearing on this 
point because a hearing will not be granted if there is no genuine and 
substantial factual issue to be resolved (Sec.  12.24(b)(1)).
---------------------------------------------------------------------------

    \3\ R.A. Glass and H.D. Smith, ``Radioactive Isomer Production 
in Foods by Gamma Rays and X-rays,'' Stanford Research Institute 
Report S-594, No. 3 (DA 19-129-1QM-1511), 1960.
---------------------------------------------------------------------------

    Public Citizen has failed to submit any evidence that would call 
into question the scientific validity of extrapolation of results 
obtained at higher energy levels and radiation doses to draw 
conclusions regarding effects that might be produced at lower energy 
levels and doses. Public Citizen is merely alleging that this approach 
is scientifically unsound. 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 or 
contentions (Sec.  12.24(b)(2)).
    In its second objection, Public Citizen contends that the Wakeford 
report is cited in the final rule to support the statement that 
electrons with energies of 8-10 MeV induced an extremely small level of 
radioactivity in various types of food, but that this statement is 
irrelevant to this petition because the petition concerns the use of x-
rays. The objection further asserts that the statement in the final 
rule ``FDA would not expect any detectable radioactivity above 
background in food resulting from the petitioned use,'' is based on no 
data or evidence.
    Contrary to Public Citizen's contention, the Wakeford report did 
concern the use of x-rays. As referenced in the final rule, the report 
by Wakeford, Blackburn, and Swallow (FDA inadvertently omitted the name 
of the third co-author, A.J. Swallow), titled ``Induction and Detection 
of Radioactivity in Foodstuffs Irradiated with 10 MeV Electrons and X-
rays,'' studied food irradiated with electron beams as well as with 
high energy bremsstrahlung x-rays. The authors state that the food was 
irradiated directly by 0-10 MeV x-rays to a maximum dose of 15-20 kGy 
(the results table shows an average dose ranging from 8.8 to 14 kGy, 
which is 17,600 to 28,000 times higher than the maximum permitted dose 
level under the final rule of 0.5 Gy). The authors concluded that the 
induced activity from the 0-10 MeV bremsstrahlung x-rays was extremely 
small. Public Citizen provided no information to support its contention 
that the radiation reported as x-rays in the Wakeford report is 
irrelevant to the safety review of the subject additive. FDA is denying 
the request for a hearing on this point because a hearing will not be 
held on the basis of mere allegations or denials or general 
descriptions of positions or contentions (Sec.  12.24(b)(2)).
    Similarly, the objection does not identify any evidence to support 
its assertion that FDA's conclusion is based on no data or evidence. 
The data and evidence relied upon by FDA is set out in the final rule. 
The Wakeford report, the WHO report and Findlay report are all part of 
the data relied upon by FDA in making its determination. FDA is denying 
the request for a hearing on this point because a hearing will not be 
held on the basis of mere allegations or denials or general 
descriptions of positions or contentions (Sec.  12.24(b)(2)).
    Public Citizen also states in its second objection that, according 
to the Wakeford report, x-rays of energy greater than 3 MeV could 
induce radioactivity, and four isotopes can be activated at x-ray 
energies below 5 MeV and cause neutron induced activity in food. Among 
the four isotopes, Public Citizen specifically mentions carbon-13, 
oxygen-17, and deuterium. The objection does not show that FDA failed 
to consider important information that would have altered the agency's 
conclusion that the x-rays at energies up to 10 MeV at the maximum 
proposed dose of 0.5 Gy will result in negligible amounts of induced 
radioactivity in food. Indeed, the WHO report cited in the final rule 
concluded that thresholds for inducing radioactivity in some isotopes 
is less than 10 MeV, but that the probability of radioactivity being 
induced under these conditions is so low that it would not be detected 
by methods that can determine activity that is only 1 percent of what 
occurs naturally in food. The language from the Wakeford report cited 
in the objection is consistent with the conclusions in the WHO report. 
Public Citizen identifies no information to support a conclusion 
contrary to that reached by FDA. Therefore, FDA is denying the request 
for a hearing on this point because a hearing will not be held if there 
is no factual issue that can be resolved by available and specifically 
identified reliable evidence (Sec.  12.24(b)(2)).
    In its third objection, Public Citizen states that the Findlay 
report is not relevant to the petition because induction of 
radioactivity in food was studied using electron beams whereas the 
petition concerns the use of x-rays.

[[Page 39560]]

In support of its assertion, Public Citizen references a report from 
the International Consultative Group on Food Irradiation titled ``The 
Development of X-Ray Machines for Food Irradiation (Proceedings of a 
Consultants' Meeting),'' dated October 1995 (ICGFI report), for its 
statement that ``neutron activity produced by 5 MeV x-rays is in the 
order of 60 times greater than that produced by 10 MeV electrons.''
    However, contrary to Public Citizen's objection, the ICGFI report 
shows that the difference in expected neutron activation in irradiated 
food from electron beams and x-rays has been calculated, thereby 
permitting use of electron beam studies to estimate neutron activation 
expected from irradiation with x-rays. Public Citizen has offered no 
evidence to support its assertion that electron beam studies are 
inappropriate to support conclusions about x-ray irradiation. FDA is 
denying the request for a hearing on this point because the evidence 
submitted by Public Citizen in support of their argument, even if 
established at a hearing, would not be adequate to justify resolution 
of the factual issue in the way sought by the objector (Sec.  
12.24(b)(3)).
    Moreover, it bears noting that the ICGFI report directly supports 
FDA's conclusion of safety in the final rule, when it cites 10 MeV x-
rays at doses less than 0.5 Gy (the maximum energy and dosage in the 
final rule) as an example of ``extremely low'' dosage that ``would not 
produce any significant radioactivity.'' Public Citizen's reference to 
the conclusion in the ICGFI report that ``increasing the energy of x-
rays above 7.5 MeV would result in * * * possible induction of 
radioactivity in the irradiated food'' is unavailing because that 
conclusion refers to the uses permitted by the Codex Alimentarius 
Commission for treating food at dosages up to 10 kGy, which is 20,000 
times higher than the 0.5 Gy maximum dosage permitted by the final rule 
for inspecting food.
    Although Public Citizen alleged that the studies that FDA evaluated 
do not support the safety of x-rays of 10 MeV or lower used for 
inspection of cargo containers that may contain food, Public Citizen 
did not present any evidence that would have led to a different 
conclusion concerning the safety of the subject additive. Because 
Public Citizen's first and second objections provided no information to 
support their assertions regarding FDA's safety review, they provide no 
basis for FDA to reconsider its decision to issue the cargo inspection 
final rule. As noted previously, a hearing will not be granted on the 
basis of general descriptions of positions and contentions (see Sec.  
12.24(b)(1) and (b)(2)). Public Citizen's third objection relied on 
information that, even if established at a hearing, would not be 
adequate to justify resolution of the factual issue in the way sought 
by the objector. A hearing will be denied if the information submitted 
are insufficient to justify the factual determination urged, even if 
accurate (Sec.  12.24(b)(3)). The issues posed by Public Citizen in 
support of the objections do not justify the granting of a hearing.

V. Summary and Conclusions

    The safety of x-rays produced by a machine source at energies of 10 
MeV or lower, to inspect food irradiated at doses up to 0.5 Gy has been 
thoroughly tested, and the data have been reviewed by the agency. As 
discussed previously, FDA concluded that the available studies 
establish the safety of food for human consumption irradiated at doses 
up to 0.5 Gy as a result of being subjected to x-rays produced by a 
machine source at energies of 10 MeV or lower. The petitioner has the 
burden to demonstrate safety before FDA can approve the use of a food 
additive. Nevertheless, once the agency 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 
(American Cyanamid Co. v. FDA, 606 F. 2d 1307, 1314-1315 (D.C. Cir. 
1979)). For the reasons set out previously, the objections do not raise 
genuine and substantial issues of fact supported by specifically 
identified reliable evidence that, if established at a hearing would be 
adequate to justify resolution in the way sought by Public Citizen. 
Therefore, Public Citizen's objections are not sufficient to justify a 
hearing under the requirements of Sec.  12.24(b). Accordingly, FDA is 
overruling the objections and is denying the requests for a hearing.

    Dated: July 11, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-13947 Filed 7-18-07; 8:45 am]
BILLING CODE 4160-01-S