[Federal Register Volume 62, Number 232 (Wednesday, December 3, 1997)]
[Rules and Regulations]
[Pages 64102-64107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31739]



[[Page 64101]]

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Part IV





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



_______________________________________________________________________



21 CFR Part 179



Irradiation in the Production, Processing, and Handling of Food; Final 
Rules

Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / 
Rules and Regulations

[[Page 64102]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket Nos. 86F-0507 and 86F-0509]


Irradiation in the Production, Processing and Handling of Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; denial of request for stay of effective date and 
for a hearing; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is denying the requests 
for a hearing that it has received on the final rule that amended the 
food additive regulations to authorize the use of sources of ionizing 
radiation for the control of food-borne pathogens in poultry. 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 the amendment to the regulation. FDA is also denying 
the request for a stay of the effective date of the amendment to the 
food additive regulations.

DATES:  Effective date confirmed: May 2, 1990.

FOR FURTHER INFORMATION CONTACT: Patricia A. Hansen, Center for Food 
Safety and Applied Nutrition (HFS-206), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3093.

SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Objections, Requests for a Hearing, and Request for a Stay
III. Standards for Granting a Hearing
IV. Analysis of Objections and Response to Hearing Requests
    A. Safety of Irradiation to Control Microorganisms in Poultry
    1. FDA's Determination of Safety
    2. Objections
    a. Letters
    b. Objections by FWI
    i. Power of the CIVO chronic rat feeding study
    ii. Addition of ethoxyquin to irradiated chicken in the CIVO 
Studies
    iii. Adequacy of all CIVO studies--other issues
    iv. Compliance with the Bureau of Foods Irradiated Food Committee 
(BFIFC) report of 1980
    B. Environmental Issues
    1. FDA's Finding of No Significant Impact
    2. Objections by FWI
    a. Information submitted by interested parties
    b. Petitioner convicted of crimes
    c. Accidents at irradiation facilities
    d. Alleged contradiction
V. Summary and Conclusions
VII. Reference

I. Introduction

    In the Federal Register of May 2, 1990 (55 FR 18538), FDA issued a 
final rule permitting the use of ionizing radiation for the control of 
food-borne pathogens in poultry (the ``poultry final rule''). This 
regulation, codified under 21 CFR 179.26, was issued in response to 
petitions filed by Radiation Technology, Inc. (RTI) (Docket No. 86F-
0507), and the U.S. Department of Agriculture (USDA), Food Safety and 
Inspection Service (FSIS) (Docket No. 86F-0509). In the Federal 
Register of March 3, 1987 (52 FR 6391), FDA published a notice 
announcing the filing of the petition submitted by RTI (FAP 8M3422), 
and in the Federal Register of February 20, 1987 (52 FR5343), FDA 
published a notice announcing the filing of the petition submitted by 
USDA, FSIS, (FAP 7M3974). FDA based its decision on data contained in 
both petitions and in its files.

II. Objections, Requests for a Hearing, and Request for a Stay

    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 may request a public hearing 
based 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.
    Under 21 CFR 171.110 of the food additive regulations, 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: (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) on which a hearing is requested must specifically so 
state; failure to request a hearing on an objection constitutes a 
waiver of the right to a hearing on that objection; and (5) requesting 
a hearing must include a detailed description and analysis of the 
factual information to be presented in support of the objection. 
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 poultry final rule, FDA received 
several identical letters with multiple signatures and two submissions 
from Food and Water, Inc. (FWI), within the 30-day objection period. 
The submissions sought revocation of the final rule and requested a 
hearing. One of FWI's objections also requested that the regulation be 
stayed pending a public hearing of the scientific issues. The other FWI 
submission also requested an extension of the ``comment'' [sic] period.

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 the regulation, a 
hearing will be granted if the material submitted by the requester 
shows, among other things, that: (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; and (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).
    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. den., 445 
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. U.S. E.P.A., 671 F.2d 
1235, 1241 (9th Cir.

[[Page 64103]]

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 (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 D.C. 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, R.C.I.A. v. NLRB, 463 F.2d 316, 322 
(D.C. Cir. 1972). (See Costle v. Pacific Legal Foundation, supra at 
1106. See also Pacific Seafarers, Inc. v. Pacific Far East Line, Inc., 
404 F.2d 804 (D.C. Cir. 1966).)
    In sum, 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 poultry final rule can be categorized into 
two broad areas--those objecting to FDA's safety determination, and 
those objecting to FDA's finding of no significant environmental impact 
(FONSI). 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 to Control Microorganisms in Poultry

1. FDA's Determination of Safety
    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 poultry final rule discussed in detail FDA's evaluation of the 
safety of ionizing radiation for use to control food-borne pathogens in 
poultry (55 FR 18538). In concluding that irradiation doses up to 3 
kiloGray (kGy) used on poultry had been shown to be safe, FDA reviewed 
three major animal feeding studies--a multigenerational feeding study 
in rats, a chronic feeding study in rats, and a 1-year feeding study in 
dogs. These studies provided the basis for FDA's conclusion regarding 
toxicological safety of the use of ionizing radiation in poultry. All 
three studies were conducted at Centraal Instituut Voor 
Voedingsonderzoek (CIVO); in each study, irradiated chicken constituted 
35 percent (by dry weight) of the test diet. FDA concluded that the 
CIVO studies were of high quality, and that they provided no evidence 
of any adverse effects attributable to consumption of diets containing 
chicken irradiated at 3 or 6 kGy.\1\
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    \1\ FDA also reviewed a carcinogenicity study in mice, conducted 
by Bio-Research Laboratories Ltd., in which the test diet contained 
50 percent irradiated chicken. The agency noted that the mouse study 
results raised no concern that irradiated chicken is carcinogenic. 
However, FDA did not rely on this study because there were 
deficiencies in the data and report.
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    FDA also reviewed all other data in its files relevant to the 
safety of irradiated chicken, including several in vitro and in vivo 
mutagenesis and genetic toxicity studies conducted using irradiated 
chicken. Such tests are often used to screen for possible association 
of carcinogenicity with a test substance by looking for positive 
mutagenic responses (genotoxicity). The agency concluded that several 
of these tests were well conducted and demonstrated the lack of 
mutagenic effects from the irradiated chicken. The agency noted 
deficiencies in other genetic toxicity tests that prevented reliance on 
such tests as a basis for a safety assessment but none of the tests 
provided evidence of a mutagenic effect.
    In sum, the agency concluded on the basis of all the evidence, 
including the toxicological information before it, that poultry 
irradiated at up to 3 kGy was safe (55 FR 18538 at 18543).
2. Objections
    a. Letters. FDA received several letters with multiple signatures 
that were substantially identical in content. This group of letters 
asserted that FDA's safety decision regarding the use of ionizing 
radiation on poultry was based solely on tests in mice, rats, and dogs, 
and raised a concern that studies in FDA's files, other than those 
described previously, used chicken that was irradiated under conditions 
that are different from those in the regulation issued by FDA. This 
group of letters states that human epidemiology studies should be 
conducted to establish the safety of the use of radiation, and that 
public hearings should be held. None of the letters included any 
information to support this objection.
    Because these submissions provided no information to support their 
assertion regarding FDA's safety review, they provide no basis for FDA 
to reconsider its decision to issue the poultry final rule. Moreover, 
these submissions provide no basis for

[[Page 64104]]

granting a hearing because a hearing request must include specifically 
identified reliable evidence that can lead to resolution of a factual 
issue in dispute. 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)(2)). Therefore, FDA is denying the hearing 
requested by these letters.
    b. Objections by FWI. In one of its submissions, FWI contends that 
``FDA has failed to demonstrate that there is a `reasonable certainty' 
that irradiation of poultry at 300 krad [3 kGy] is not harmful, and 
that therefore the Agency's approval is arbitrary and capricious.'' FWI 
gives four reasons for its contention.
    i. Power of the CIVO chronic rat feeding study. First, FWI raises 
an issue about the statistical power of the chronic feeding study in 
rats conducted by CIVO. Specifically, FWI asserts that this feeding 
study was inadequate for determining safety because the study did not 
have sufficient statistical power to demonstrate that the cancer risk 
from consumption of irradiated chicken would be less than one in a 
million. FWI stated: ``In accordance with procedures applied to food 
additives generally, testing must be of such sensitivity that even a 
small incremental risk of cancer cannot escape detection, namely one 
per million, extrapolated to a typical human consumer.'' FWI provided 
the results of statistical analyses regarding the power of the test. In 
a background statement in its submission, FWI also stated that 
``(g)iven the evidence that the formation of genotoxic radiolytic 
products can and does occur, a petitioner seeking approval of 
irradiation of poultry * * * should bear the burden of establishing the 
magnitude of expected cancer risk, or that it is below a stated 
level.'' In support of its objection, FWI submitted only a table 
entitled ``Identification of Genotoxic Radiolytic Products in 
Irradiated Organic Media or Food,'' but this table contained no 
information on genotoxicity data from irradiated poultry. FWI's 
objection did not dispute FDA's conclusion that the evidence 
demonstrated that irradiated poultry was not mutagenic (55 FR 18538 at 
18540).
    Neither FDA's guidelines nor generally accepted scientific 
procedures suggested for food additive testing recommend that 
carcinogenicity testing be sufficiently sensitive to detect an 
increased cancer risk of one in one million.\2\ FWI provided no 
information to support its contention, either by reference to FDA's 
regulations or to any other requirement. Thus, FDA concludes that this 
objection raises no issue of fact that can be resolved at a hearing. 
Instead, the objection simply states FWI's preference for a policy 
regarding carcinogenicity testing. A hearing will not be granted on 
issues of policy or law (Sec. 12.24(b)(1)).
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    \2\ In fact, it would not be feasible to conduct such testing in 
laboratory animals for substances ordinarily consumed at anything 
other than trivially low levels in the diet. Generally, to increase 
the power of a test one must increase the amount of test substance 
fed or increase the number of animals in each group. For example, 
the standard approach to assess low levels of carcinogenic risk is 
to feed a substance in large amounts, determine the risk at such a 
high dose, and extrapolate to lower doses using a linear 
extrapolation model. Using such a model to detect an increased risk 
of one in one million from a substance and assuming that the study 
design could detect a 10 percent cancer incidence at a high dose, 
one would have to feed an animal 100,000 times the amount it would 
consume under realistic conditions. This clearly cannot be done with 
a diet of chicken. Alternatively, testing thousands of animals per 
group would overwhelm normal laboratory capabilities.
    Under FDA guidelines, testing of a food additive is generally 
conducted at levels no higher than 5 percent of the diet for 
nonnutritive substances. This level can be higher for a nutritive 
substance, however, provided it does not cause a significant 
nutritional deficit (Ref. 1). As noted previously and discussed in 
detail in the poultry final rule, the CIVO studies fed chicken 
irradiated at the maximum dose allowed by the regulation, as well as 
at twice that dose, in amounts equivalent to 35 percent of the diet 
(by dry weight). Moreover, based on its review of the mutagenicity 
data, FDA concluded that there was no basis to suspect that 
irradiated chicken would be carcinogenic.
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    In addition, FDA does not dispute FWI's contention that the 
statistical power of this test is such that it cannot detect an 
increased cancer risk of one in one million. However, FWI did not 
demonstrate why prevailing on this factual issue would be adequate to 
justify the action requested (Sec. 12.24(b)(4)).
    Additionally, FWI suggested that to increase sensitivity of the 
testing the radiation dose should have been increased tenfold or that 
concentrated extracts of all radiolytic products formed by irradiating 
chicken should have been fed.\3\ Once again, FWI submitted no 
information to establish that the testing it recommended is required to 
demonstrate safety, or even that such testing would be valid to assess 
safety. Nor did FWI provide any information concerning how one can 
conduct such a study or how one can interpret the findings in the 
context of poultry irradiated at a dose not to exceed 3 kGy. Because 
FWI provided no evidence to consider in 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 (Sec. 12.24(b)(2)).
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    \3\ Irradiation doses typically can be raised only marginally 
higher than would be used in practice before they produce effects 
that would change food significantly, often producing an unpalatable 
product that animals will not eat. Special processing conditions can 
be used to minimize such effects, however, such as irradiating food 
in the frozen state in the absence of air. In the poultry final 
rule, FDA cited tests conducted at a dose approximately 10 times 
higher than the CIVO studies, which studies showed no adverse 
effects related to irradiation (55 FR 18539 at 18540). FDA relied 
primarily on the CIVO studies, however, because FDA would not expect 
irradiation of poultry at a dose below 3 kGy to be conducted using 
the processing conditions required for the higher dose.
    Extracts of irradiated foods have not been relied on primarily 
for testing because radiolytic products of food do not differ in any 
particular chemical or physical properties from other components of 
food that would allow them to be specifically extracted from food. 
Additionally, radiolytic products are typically identical to 
substances that occur naturally in foods. Therefore, FDA is not 
aware of how one could prepare an extract that would ensure the 
presence of all radiolytic products while excluding the presence of 
other similar components of food that did not result from 
irradiation. The only way to ensure that all radiolytic products are 
present is to feed the irradiated food itself.
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    ii. Addition of ethoxyquin to irradiated chicken in the CIVO 
studies. In the CIVO studies, the researchers removed water from the 
chicken by drying over hot air, in order to preserve the chicken for 
the time needed to complete the testing. Prolonged contact with hot air 
causes lipids (fats) to be oxidized to lipid peroxides, thereby 
rendering the food rancid and unpalatable. Prolonged storage can also 
lead to rancidity. Thus, the researchers added ethoxyquin, an 
antioxidant, to the chicken to prevent rancidity. Preventing rancidity 
by this means is of importance for a product dried and stored, as in 
the test.
    In its second contention, FWI states that the CIVO studies were 
seriously compromised because the addition of the antioxidant 
ethoxyquin to the chicken decreased the levels of lipid peroxides in 
the irradiated chicken to levels comparable to those in unirradiated 
chicken. FWI contends that these decreased levels would interfere with 
the observation of toxicity from the lipid peroxides that were formed 
in higher amounts during the hot air drying of irradiated chicken than 
in the unirradiated chicken.
    In the poultry final rule, FDA noted that ethoxyquin had been 
incorporated into both the control diets and the test diets in the CIVO 
studies. The agency acknowledged (55 FR 18538 at 15839 and 15840) that 
FDA reviews of the CIVO studies had raised the question of

[[Page 64105]]

whether the addition of ethoxyquin could compromise the study and that 
this issue needed to be resolved before FDA could reach a safety 
decision. After careful consideration, FDA concluded that the addition 
of ethoxyquin to prevent rancidity of the chicken fat did not confound 
the results of the study.
    The effect of ethoxyquin is to retard, during storage, the normal 
oxidation to peroxides of the fatty content of the diet. Importantly, 
ethoxyquin cannot reverse oxidation that has already taken place. In 
the CIVO studies, ethoxyquin was added after irradiation of the meat. 
Therefore, its presence would not alter the effects of radiation on the 
food (including any potential effects on the formation of lipid 
peroxides), as might occur if ethoxyquin had been added beforehand and 
were present during irradiation.\4\
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    \4\ Moreover, ethoxyquin would not be needed for poultry 
irradiated and stored under typical commercial conditions. 
Commercial needs would require processing and storage practices that 
would prevent development of rancidity in order to provide a 
marketable product. Thus, the agency does not expect that high 
levels of lipid peroxides will be present in foods that are sold for 
human consumption.
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    FWI did not dispute FDA's explanation in the final rule as to why 
addition of ethoxyquin did not compromise the CIVO studies, and 
provided no information to contradict the agency's conclusion. Further, 
FWI did not show that FDA failed to consider important information that 
would have altered the agency's conclusion on this issue. Therefore, 
FDA is denying this objection and request for a hearing 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)).
    iii. Adequacy of all CIVO studies--other issues. In its objection, 
FWI also refers to
 ``* * * additional concerns regarding all the CIVO studies (storage of 
the irradiated chicken for periods far in excess of those anticipated 
for human consumers; possibly excessive supplementation of diets with 
vitamins A and E) and for the chronic feeding study in particular as 
noted in memoranda provided by the FDA * * *.'' FWI submitted no 
information to substantiate these concerns. FWI stated, however, that 
the short amount of time available to file objections following 
issuance of the poultry final rule precluded a detailed examination of 
the issues raised by these studies.\5\
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    \5\ With respect to the limited time available for objections, 
FDA notes that the notice of filing for FAP 8M3422, which petition 
contained these studies, was published more than 3 years prior to 
FDA's decision. Thus, all safety information in the petition, 
including the CIVO studies, was available to FWI under the Freedom 
of Information Act for a significant period of time (21 CFR 
171.1(h)(1)).
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    FDA is denying FWI's request for a hearing to the extent that it is 
based on these particular contentions because FWI's request identified 
no particular factual issue in dispute and also because FWI provided no 
specific evidence that could be considered at such a hearing. As noted, 
a hearing will not be granted on the basis of mere allegations or 
descriptions of positions or contentions (see Sec. 12.24(b)(1) and 
(b)(2)).
    iv. Compliance with the Bureau of Foods Irradiated Food Committee 
(BFIFC) report of 1980. Finally, FWI asserts that the irradiated 
poultry final rule did not comply with all the recommendations of the 
BFIFC report issued in 1980. FWI also expressed disagreement with 
recommendations in that report.
    The BFIFC report is an internal document prepared by FDA scientists 
that provides recommendations for evaluating the safety of irradiated 
foods based on the known effects of radiation on foods and on the 
capabilities of toxicological testing. The report was made available to 
the public for comment in the Federal Register of March 27, 1981 (46 FR 
18992). While the report and the comments received on it have aided 
FDA's thinking regarding the safety testing of irradiated foods, the 
report established no requirements. FDA cited the BFIFC report in a 
footnote in the poultry final rule (55 FR 18538 at 18541) to illustrate 
how the toxicological data the agency considered (much of which was 
submitted before issuance of the BFIFC report) compared to the 
recommendations in the report.
    Consistent with section 409 of the act, FDA's decision on the 
safety of irradiation of poultry was based on the entire record of that 
proceeding. Further, as discussed in the poultry final rule, in 
reaching its conclusion that irradiation of poultry under conditions 
specified in the regulation does not present a toxicological hazard (55 
FR 18538 at 18541), FDA evaluated both studies submitted in the 
petitions as well as other studies of irradiated chicken available in 
agency files. Although FWI alleged that some of the studies that FDA 
evaluated did not comply with recommendations in the BFIFC report, FWI 
did not present any evidence that these alleged inconsistencies, even 
if true, would have led to a different conclusion concerning the safety 
of irradiation of poultry. Therefore, FDA is denying this objection and 
request for a hearing because it raises no factual issue that, even if 
resolved in the way sought by the objection, would justify the action 
requested (Sec. 12.24(b)(4)).

B. Environmental Issues

1. FDA's Finding of No Significant Impact
    In reaching its decision to permit the irradiation of poultry at up 
to 3 kGy, the agency carefully considered the environmental effects of 
this action, as required under the National Environmental Policy Act 
(NEPA). After carefully reviewing the environmental assessment (EA) 
submitted by FSIS for FAP 7M3974 and environmental information 
submitted by RTI for FAP 8M3422, FDA concluded that this particular 
action would not have a significant impact on the human environment, 
and that an environmental impact statement was not required. The 
agency's FONSI and the evidence supporting it, including material from 
both the FSIS' EA and the submissions from RTI, were placed on display 
at FDA's Dockets Management Branch.
    A key element in the EA and in FDA's FONSI is the regulatory 
controls exerted by various regulatory bodies, such as the Nuclear 
Regulatory Commission (NRC), the Occupational Safety and Health 
Administration, the Department of Transportation, the Environmental 
Protection Agency, FDA itself, and various State and local authorities. 
These controls are designed to ensure that any substances that may be 
lawfully emitted into the environment will not pose a significant 
environmental impact. These controls and regulations were cited in the 
materials considered by FDA, which material formed the basis of its 
FONSI.
2. Objections by FWI
    In its second objection, FWI contends that FDA's FONSI is 
``inadequate.'' FWI requested the preparation of an Environmental 
Impact Statement (EIS) and an open public hearing on the existing and 
potential dangers of the irradiation industry. Specifically, FWI 
maintained that the agency's FONSI is inadequate because it:
    * * * relies strictly on information submitted by those who 
stand to gain from the approval of poultry irradiation; * * * 
extensively cites materials submitted by Martin Welt, a convicted 
felon with a criminal record of deceiving federal regulatory 
agencies; * * * completely disregards the fact that there have 
already been numerous irradiation accidents and, thus, must be 
deemed inadequate.
    The objection also states that:
    In documents released by FSIS within the past year, initially 
there is no mention of

[[Page 64106]]

irradiation as a potential research area; and then, later, the FSIS 
declares that alternatives to the irradiation solution need not be 
discussed when considering the environmental impact of the 
technology. This contradiction alone warrants a hearing and should 
prove the need for a full Environmental Impact Statement.
    Finally, the objection also requested an extension of the comment 
period, asserting that:
    FDA; * * * received the original petition (FAP 7M3974) seeking 
approval for poultry irradiation in February, 1977 [sic] and, thus, 
it has taken your agency more than 13 years to come to your final 
decision. You are now granting the public a mere 30 days to comment 
on a ruling that took your agency more than 13 years to decide upon.
    FDA notes that FWI misinterprets the statutory 30-day objection 
period, which is specified in section 409(f) of the act, as an 
opportunity for comment. The poultry final rule issued in the Federal 
Register of May 2, 1990, was a final rule and the opportunity for 
comment ended at that time. As noted in section I of this document, the 
agency had announced in the Federal Register of February 20, 1987, the 
filing of FAP 7M3974 and the filing of FAP 8M3422 in the Federal 
Register of March 3, 1987. Thus, FWI had notice of the filing of the 
petitions and had ample time to comment. The time to submit objections 
is established by statute (section 409(f) of the act), and thus, is not 
a deadline established by FDA. However, because the submission from FWI 
was submitted within the objection period, FDA is considering it as an 
objection.
    In the following discussion, FDA addresses each of FWI's points 
outlined previously, as well as the data and information filed in 
support of each, comparing each to the standards for a hearing in 
Sec. 12.24.
    a. Information submitted by interested parties. The mere fact that 
information has been submitted by a party with an interest in an issue 
under agency consideration is not sufficient reason to reject that 
information.\6\ In fact, each petitioner is required by FDA regulations 
to submit an EA as part of its food additive petition unless the action 
sought by the petitioner qualifies for a categorical exclusion. In 
assessing the potential environmental impact that could result from the 
approval of use of a food additive, including the use of sources of 
radiation in food processing, FDA critically evaluates the information 
submitted in the petitioner's EA, consistent with the applicable agency 
regulations (part 25 (21 CFR part 25)).
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    \6\ Moreover, the agency notes that, the USDA, one of the 
petitioners, does not stand to gain from the approval of poultry 
irradiation, contrary to FWI's contention that the environmental 
information was submitted by those who do.
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    FWI has failed to submit any evidence that would call into question 
the validity of any of the specific information submitted by the 
petitioners and relied upon by FDA. FWI is merely asserting its opinion 
that an EA submitted by a petitioner is inherently inadequate. 
Accordingly, the agency is denying FWI's request for a hearing because 
a hearing will not be granted on issues of policy or law 
(Sec. 12.24(b)(4)), nor will one be granted on the basis of mere 
allegations or denials or general descriptions of positions or 
contentions (Sec. 12.24(b)(1)).
    b. Petitioner convicted of crimes.  In its objection, FWI also 
contends that the agency's FONSI is inadequate because ``* * * it 
extensively cites materials submitted by Martin Welt, a convicted felon 
with a criminal record of deceiving federal regulatory agencies.'' FWI 
did not provide any specific information to question the reliability or 
accuracy of the environmental information contained in FAP 8M3422\7\ or 
FAP 7M3974. To support its objection, FWI submitted a copy of the 
government's sentencing memorandum in United States v. Welt, Criminal 
#88-87, U.S. District Court, District of New Jersey, 1988, (dated 
August 30, 1988, from Samuel A. Alito, Jr., United States Attorney, to 
the Honorable Maryanne Trump Barry, United States District Court, 
District of New Jersey, with attachments).
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    \7\ Dr. Martin Welt was the president of RTI when it submitted 
FAP 8M3422. As the responsible company official, he signed the 
environmental information submitted in that petition. At the time 
FDA issued its final rule, Dr. Welt was no longer part of RTI 
management.
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    A food additive regulation is a conclusion that use of the additive 
in compliance with the conditions of use specified in such regulation 
is safe; a food additive regulation is not a license for an individual 
petitioner. Similarly, the FONSI is a conclusion that use of the 
additive under the proposed conditions of use, which includes 
compliance with applicable Federal, State, and local regulations, will 
not result in a significant impact on the human environment. The fact 
that Martin Welt (once the president of one of the petitioners) is a 
convicted felon is not in dispute. However, Dr. Welt's status is wholly 
irrelevant to the agency's evaluation of the potential environmental 
impact of the poultry final rule. FDA evaluated the environmental 
information supplied by RTI and the EA submitted by FSIS in an 
independent, scientific and critical fashion. It is the quality of the 
data and conclusions drawn from the information provided that are 
important. FWI raised no allegation as to the accuracy or credibility 
of the submitted information, nor did it identify any information FDA 
ignored or misinterpreted in issuing its FONSI. Accordingly, FDA is 
denying FWI's request for a hearing on this issue because a hearing 
will not be granted on factual issues that are not determinative to the 
action requested (see Sec. 12.24(b)(4)).
    c. Accidents at irradiation facilities. FWI also objected to the 
agency's FONSI on the grounds that the EA prepared by USDA ``fails to 
mention the numerous irradiation accidents which have already occurred 
in the U.S.--many of which have resulted in environmental, worker and 
product contamination.'' FWI contends that should the poultry industry 
widely adopt the use of irradiation, the need for irradiation 
facilities will be greatly expanded and that there are additional risks 
inherent in such an expanded irradiation industry. In support of its 
objection, FWI submitted the following:
    1. A document entitled ``Fact Sheet--Radiation Sterilizers, Inc. 
(RSI) Incident, prepared by James L. Setser.''
    2. A document entitled ``Summary--First Interim Report of the RSI 
Incident Evaluation Task Force,'' June 1989.
    3. A document entitled ``Statement Before the Incident Evaluation 
Task Force for the Governor of Georgia,'' prepared by Judith H. 
Johnsrud, Research Director, Food and Water, Inc., October 17, 1988.
    4. A list of ``Irradiation incidents at large scale gamma 
irradiation facilities, 1974 to 1988,'' compiled by Brion Sprinsock, 
National Coalition to Stop Food Irradiation.
    5. A transcript of the morning session of the U.S. Nuclear 
Regulatory Commission Irradiator Workshop held on May 24, 1988.
    FDA's action in issuing a food additive regulation permitting the 
irradiation of poultry at up to 3 kGy allows licensed irradiation 
processors to include poultry among the products treated at their 
facilities. Such irradiation of poultry is subject, however, to all 
applicable regulations, including local, State, and Federal safety 
regulations. FDA's FONSI is a statement that irradiation of poultry, in 
compliance with all applicable regulations, will not have a significant 
impact on the environment. It is entirely reasonable for FDA to 
evaluate the environmental effects of this food additive approval on 
the basis that facilities will operate in compliance with applicable 
safety rules. To assume that facilities will not operate in such

[[Page 64107]]

compliance would be highly speculative and essentially be a requirement 
that FDA perform a worst-case analysis when evaluating the potential 
environmental impact of an agency action. This is simply not what NEPA 
requires (see Robertson v. Methow Valley Citizens Council, 490 U.S. 
332, 355 (1989)).
    Importantly, the poultry final rule, in and of itself, does not 
permit any additional building or operation of irradiation facilities, 
and thus, does not directly result in any increased risk of accidents 
at such facilities. Before an irradiation facility is built, other 
regulatory agencies with oversight regarding its site design, location, 
licensing, and radiation control procedures (such as the NRC) must 
issue permits. The evaluation of the environmental impact of the 
construction and operation of these facilities is, under NEPA, the 
responsibility of the licensing agency or agencies. FDA's environmental 
evaluation in this case, and thereby FDA's FONSI, was not intended to 
reassess the environmental impact issues that are the responsibility of 
other regulatory agencies. In fact, under NEPA, an agency is not 
required to assess the environmental impact of a portion of a project 
where a second agency has jurisdiction over such portion (see State of 
N.C. v. City of Virginia Beach, 951 F.2d 596 (4th Cir. 1991)).
    Accordingly, even if there have been accidents at irradiation 
facilities, or even if there would be an increased risk of such 
accidents as a result of the poultry final rule, these facts have no 
bearing on FDA's EA of its action. Thus, FDA is denying a hearing on 
this issue because a hearing will not be granted on factual issues that 
are not determinative with respect to the action requested 
(Sec. 12.24(b)(4)).
     d. Alleged contradiction. FWI also objects to FDA's FONSI on the 
grounds of an alleged contradiction between information in FSIS's EA 
and other FSIS documents and cites an article from The Food and Drug 
Letter (April 28, 1989) in support of its objection. According to FWI, 
FSIS declared in its EA that alternatives to irradiation need not be 
discussed when considering the environmental impact of the technology 
and yet, in the article in The Food and Drug Letter, did not mention 
irradiation as one of the research areas for potentially solving the 
bacterial problem.
     The material cited by FWI does not support its contention. In 
preparing an EA, petitioners are required, under Sec. 25.31a(a)(11), to 
consider alternatives to the proposed action if potential adverse 
environmental impacts have been identified for the proposed action 
(Sec. 25.31a(a)(11)). After evaluating the FSIS' EA, the agency found 
that irradiation of poultry in compliance with existing laws and 
regulations will not lead to a significant impact on the environment. 
Because no adverse impacts are expected, the agency did not require, 
and FSIS did not address, alternatives to the proposed action under 
format item 11 of the EA. It should also be noted that, contrary to 
FWI's contention, FSIS did not claim in its EA that irradiation is the 
only solution to food-borne pathogens.
    The article referred to by FWI from The Food and Drug Letter 
discusses areas identified by FSIS for future research for potential 
solutions to the problem of microbial contamination in poultry; at that 
time, irradiation had already been a subject of research as a potential 
solution to this problem. Thus, there is no contradiction between the 
statements made by FSIS in its EA and in the article in The Food and 
Drug Letter.
    In order to justify a hearing on this issue, FWI would need to 
provide credible evidence that challenges FDA's conclusion that the 
irradiation of poultry in compliance with existing regulations will not 
lead to a significant impact on the environment (see Sec. 12.24(b)(2)). 
FWI has not done so and, thus, has failed to meet a threshold burden of 
tendering evidence that suggests a need for a hearing (Costle v. 
Pacific Legal Foundation, supra, 445 U.S. at 214).

V. Summary and Conclusions

    The safety of poultry irradiated at up to 3 kGy 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 poultry irradiated at doses up to 3 kGy for human 
consumption.
    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 F2d. 1307, 1314-
1315 (D.C. Cir. 1979)).
     None of those objecting to the final rule has identified any 
information in the record that was misconstrued by FDA to support the 
objector's claim that the agency incorrectly concluded that consumption 
of poultry irradiated at up to 3 kGy is safe. Nor has any objector 
established that the agency overlooked significant information in 
reaching its conclusion. Indeed, none of the objections presented any 
relevant evidence that has not already been carefully reviewed and 
weighed by the agency. The agency has determined that the objections do 
not raise any genuine and substantial issue of fact that would justify 
an evidentiary hearing on any of the objections raised (Sec. 12.24(b)). 
Accordingly, FDA is overruling the objections and is denying the 
requests for a hearing. In addition, FWI's request for a stay of the 
effectiveness of the May 2, 1990, regulation until a hearing is held is 
moot because FDA is denying all hearing requests.
     FDA is confirming May 2, 1990, as the effective date of the 
regulation.

VI. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. FDA, Bureau of Foods, ``Toxicological Principles for the 
Safety Assessment of Direct Food Additives and Color Additives Used 
in Food,'' Appendix III, p. 18, 1982.

    Dated: November 26, 1997.
Michael A. Friedman
Lead Deputy Commissiner for the Food and Drug Administration.
[FR Doc. 97-31739 Filed 12-2-97; 8:45 am]
BILLING CODE 4160-01-F