64102 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations

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.

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 § 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 § 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.
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations 64103

1FDA 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.

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

§ 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 ‘‘selfevidently’’ 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 § 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

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
64104 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations

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.

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.

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

(§ 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 (§ 12.24(b)(1)).

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

(§ 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 (§ 12.24(b)(2)).

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
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations 64105

4Moreover, 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.

5With 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)).

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

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 (§ 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

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 § 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 (§ 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
64106 Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 / Rules and Regulations

6Moreover, 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.

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.

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 § 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)).

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 (§ 12.24(b)(4)),

nor will one be granted on the basis of

mere allegations or denials or general

descriptions of positions or contentions

(§ 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 8M34227

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).

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

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

(§ 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

§ 25.31a(a)(11), to consider alternatives

to the proposed action if potential

adverse environmental impacts have

been identified for the proposed action

(§ 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

§ 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 (§ 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

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 179

[Docket No. 94F–0289]

Irradiation in the Production,

Processing and Handling of Food

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of a source of radiation to

treat refrigerated or frozen uncooked

meat, meat byproducts, and certain meat

food products to control foodborne

pathogens and extend product shelf-life.

This action is in response to a petition

filed by Isomedix, Inc.