Irradiation in the Production, Processing and Handling of Food

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