[Federal Register Volume 62, Number 232 (Wednesday, December 3, 1997)]
[Rules and Regulations]
[Pages 64102-64107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31739]
[[Page 64101]]
_______________________________________________________________________
Part IV
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
21 CFR Part 179
Irradiation in the Production, Processing, and Handling of Food; Final
Rules
Federal Register / Vol. 62, No. 232 / Wednesday, December 3, 1997 /
Rules and Regulations
[[Page 64102]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 179
[Docket Nos. 86F-0507 and 86F-0509]
Irradiation in the Production, Processing and Handling of Food
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; denial of request for stay of effective date and
for a hearing; confirmation of effective date.
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SUMMARY: The Food and Drug Administration (FDA) is denying the requests
for a hearing that it has received on the final rule that amended the
food additive regulations to authorize the use of sources of ionizing
radiation for the control of food-borne pathogens in poultry. After
reviewing the objections to the final rule and the requests for a
hearing, the agency has concluded that the objections do not raise
issues of material fact that justify a hearing or otherwise provide a
basis for revoking the amendment to the regulation. FDA is also denying
the request for a stay of the effective date of the amendment to the
food additive regulations.
DATES: Effective date confirmed: May 2, 1990.
FOR FURTHER INFORMATION CONTACT: Patricia A. Hansen, Center for Food
Safety and Applied Nutrition (HFS-206), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-418-3093.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Introduction
II. Objections, Requests for a Hearing, and Request for a Stay
III. Standards for Granting a Hearing
IV. Analysis of Objections and Response to Hearing Requests
A. Safety of Irradiation to Control Microorganisms in Poultry
1. FDA's Determination of Safety
2. Objections
a. Letters
b. Objections by FWI
i. Power of the CIVO chronic rat feeding study
ii. Addition of ethoxyquin to irradiated chicken in the CIVO
Studies
iii. Adequacy of all CIVO studies--other issues
iv. Compliance with the Bureau of Foods Irradiated Food Committee
(BFIFC) report of 1980
B. Environmental Issues
1. FDA's Finding of No Significant Impact
2. Objections by FWI
a. Information submitted by interested parties
b. Petitioner convicted of crimes
c. Accidents at irradiation facilities
d. Alleged contradiction
V. Summary and Conclusions
VII. Reference
I. Introduction
In the Federal Register of May 2, 1990 (55 FR 18538), FDA issued a
final rule permitting the use of ionizing radiation for the control of
food-borne pathogens in poultry (the ``poultry final rule''). This
regulation, codified under 21 CFR 179.26, was issued in response to
petitions filed by Radiation Technology, Inc. (RTI) (Docket No. 86F-
0507), and the U.S. Department of Agriculture (USDA), Food Safety and
Inspection Service (FSIS) (Docket No. 86F-0509). In the Federal
Register of March 3, 1987 (52 FR 6391), FDA published a notice
announcing the filing of the petition submitted by RTI (FAP 8M3422),
and in the Federal Register of February 20, 1987 (52 FR5343), FDA
published a notice announcing the filing of the petition submitted by
USDA, FSIS, (FAP 7M3974). FDA based its decision on data contained in
both petitions and in its files.
II. Objections, Requests for a Hearing, and Request for a Stay
Section 409(f) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 348(f)), provides that, within 30 days after
publication of an order relating to a food additive regulation, any
person adversely affected by such order may file objections, specifying
with particularity the provisions of the order ``deemed objectionable,
stating reasonable grounds therefor,'' and may request a public hearing
based upon such objections. FDA may deny a hearing request if the
objections to the regulation do not raise genuine and substantial
issues of fact that can be resolved at a hearing.
Under 21 CFR 171.110 of the food additive regulations, objections
and requests for a hearing are governed by part 12 (21 CFR part 12) of
FDA's regulations. Under Sec. 12.22(a) each objection: (1) Must be
submitted on or before the 30th day after the date of publication of
the final rule; (2) must be separately numbered; (3) must specify with
particularity the provision of the regulation or proposed order
objected to; (4) on which a hearing is requested must specifically so
state; failure to request a hearing on an objection constitutes a
waiver of the right to a hearing on that objection; and (5) requesting
a hearing must include a detailed description and analysis of the
factual information to be presented in support of the objection.
Failure to include a description and analysis for an objection
constitutes a waiver of the right to a hearing on that objection.
Following publication of the poultry final rule, FDA received
several identical letters with multiple signatures and two submissions
from Food and Water, Inc. (FWI), within the 30-day objection period.
The submissions sought revocation of the final rule and requested a
hearing. One of FWI's objections also requested that the regulation be
stayed pending a public hearing of the scientific issues. The other FWI
submission also requested an extension of the ``comment'' [sic] period.
III. Standards for Granting a Hearing
Specific criteria for deciding whether to grant or deny a request
for a hearing are set out in Sec. 12.24(b). Under the regulation, a
hearing will be granted if the material submitted by the requester
shows, among other things, that: (1) There is a genuine and substantial
factual issue for resolution at a hearing; a hearing will not be
granted on issues of policy or law; (2) the factual issue can be
resolved by available and specifically identified reliable evidence; a
hearing will not be granted on the basis of mere allegations or denials
or general descriptions of positions and contentions; (3) the data and
information submitted, if established at a hearing, would be adequate
to justify resolution of the factual issue in the way sought by the
requestor; a hearing will be denied if the data and information
submitted are insufficient to justify the factual determination urged,
even if accurate; and (4) resolution of the factual issue in the way
sought by the person is adequate to justify the action requested; a
hearing will not be granted on factual issues that are not
determinative with respect to the action requested (e.g., if the action
would be the same even if the factual issue were resolved in the way
sought).
A party seeking a hearing is required to meet a ``threshold burden
of tendering evidence suggesting the need for a hearing'' (Costle v.
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980) reh. den., 445
U.S. 947 (1980), citing Weinberger v. Hynson, Westcott & Dunning, Inc.,
412 U.S. 609, 620-621 (1973)). An allegation that a hearing is
necessary to ``sharpen the issues'' or to ``fully develop the facts''
does not meet this test (Georgia Pacific Corp. v. U.S. E.P.A., 671 F.2d
1235, 1241 (9th Cir.
[[Page 64103]]
1982)). If a hearing request fails to identify any factual evidence
that would be the subject of a hearing, there is no point in holding
one. In judicial proceedings, a court is authorized to issue summary
judgment without an evidentiary hearing whenever it finds that there
are no genuine issues of material fact in dispute and a party is
entitled to judgment as a matter of law (see Rule 56, Federal Rules of
Civil Procedure). The same principle applies in administrative
proceedings (see Sec. 12.28).
A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact concerning which a meaningful
hearing might be held (Pineapple Growers Association v. FDA, 673 F.2d
1083, 1085 (9th Cir. 1982)). Where the issues raised in the objection
are, even if true, legally insufficient to alter the decision, the
agency need not grant a hearing (Dyestuffs and Chemicals, Inc. v.
Flemming, 271 F.2d 281 (8th Cir. 1959), cert. denied, 362 U.S. 911
(1960)). FDA need not grant a hearing in each case where an objector
submits additional information or posits a novel interpretation of
existing information (see United States v. Consolidated Mines &
Smelting Co., 455 F.2d 432 (9th Cir. 1971)). In other words, a hearing
is justified only if the objections are made in good faith and if they
``draw in question in a material way the underpinnings of the
regulation at issue'' (Pactra Industries v. CPSC, 555 F.2d 677 (9th
Cir. 1977)). Finally, courts have uniformly recognized that a hearing
need not be held to resolve questions of law or policy (see Citizens
for Allegan County, Inc. v. FPC, 414 F.2d 1125 (D.C. Cir. 1969); Sun
Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir.), cert. denied, 358 U.S.
872 (1958)).
Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were adequately raised and
considered in an earlier proceeding. Once an issue has been so raised
and considered, a party is estopped from raising that same issue in a
later proceeding without new evidence. The various judicial doctrines
dealing with finality can be validly applied to the administrative
process. In explaining why these principles ``self-evidently'' ought to
apply to an agency proceeding, the D.C. Circuit wrote:
The underlying concept is as simple as this: Justice requires
that a party have a fair chance to present his position. But overall
interests of administration do not require or generally contemplate
that he will be given more than a fair opportunity.
Retail Clerks Union, Local 1401, R.C.I.A. v. NLRB, 463 F.2d 316, 322
(D.C. Cir. 1972). (See Costle v. Pacific Legal Foundation, supra at
1106. See also Pacific Seafarers, Inc. v. Pacific Far East Line, Inc.,
404 F.2d 804 (D.C. Cir. 1966).)
In sum, a hearing request must present sufficient credible evidence
to raise a material issue of fact and the evidence must be adequate to
resolve the issue as requested and to justify the action requested.
IV. Analysis of Objections and Response to Hearing Requests
The objections to the poultry final rule can be categorized into
two broad areas--those objecting to FDA's safety determination, and
those objecting to FDA's finding of no significant environmental impact
(FONSI). FDA addresses each of the objections below, as well as the
data and information filed in support of each, comparing each objection
and the information submitted in support of it to the standards for
granting a hearing in Sec. 12.24.
A. Safety of Irradiation to Control Microorganisms in Poultry
1. FDA's Determination of Safety
Under 21 CFR 170.3(i), safety of a food additive means that there
is a reasonable certainty in the minds of competent scientists that the
substance is not harmful under the intended conditions of use. FDA's
regulations reflect the Congressional judgment that the additive must
be properly tested and such tests carefully evaluated, but that the
additive need not, indeed cannot, be shown to be safe to an absolute
certainty. The House Report on the Food Additives Amendment of 1958
stated: ``Safety requires proof of a reasonable certainty that no harm
will result from the proposed use of the additive. It does not--and
cannot--require proof beyond any possible doubt that no harm will
result under any conceivable circumstance'' (H. Rept. 2284, 85th Cong.,
2d sess., 1958).
The poultry final rule discussed in detail FDA's evaluation of the
safety of ionizing radiation for use to control food-borne pathogens in
poultry (55 FR 18538). In concluding that irradiation doses up to 3
kiloGray (kGy) used on poultry had been shown to be safe, FDA reviewed
three major animal feeding studies--a multigenerational feeding study
in rats, a chronic feeding study in rats, and a 1-year feeding study in
dogs. These studies provided the basis for FDA's conclusion regarding
toxicological safety of the use of ionizing radiation in poultry. All
three studies were conducted at Centraal Instituut Voor
Voedingsonderzoek (CIVO); in each study, irradiated chicken constituted
35 percent (by dry weight) of the test diet. FDA concluded that the
CIVO studies were of high quality, and that they provided no evidence
of any adverse effects attributable to consumption of diets containing
chicken irradiated at 3 or 6 kGy.\1\
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\1\ FDA also reviewed a carcinogenicity study in mice, conducted
by Bio-Research Laboratories Ltd., in which the test diet contained
50 percent irradiated chicken. The agency noted that the mouse study
results raised no concern that irradiated chicken is carcinogenic.
However, FDA did not rely on this study because there were
deficiencies in the data and report.
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FDA also reviewed all other data in its files relevant to the
safety of irradiated chicken, including several in vitro and in vivo
mutagenesis and genetic toxicity studies conducted using irradiated
chicken. Such tests are often used to screen for possible association
of carcinogenicity with a test substance by looking for positive
mutagenic responses (genotoxicity). The agency concluded that several
of these tests were well conducted and demonstrated the lack of
mutagenic effects from the irradiated chicken. The agency noted
deficiencies in other genetic toxicity tests that prevented reliance on
such tests as a basis for a safety assessment but none of the tests
provided evidence of a mutagenic effect.
In sum, the agency concluded on the basis of all the evidence,
including the toxicological information before it, that poultry
irradiated at up to 3 kGy was safe (55 FR 18538 at 18543).
2. Objections
a. Letters. FDA received several letters with multiple signatures
that were substantially identical in content. This group of letters
asserted that FDA's safety decision regarding the use of ionizing
radiation on poultry was based solely on tests in mice, rats, and dogs,
and raised a concern that studies in FDA's files, other than those
described previously, used chicken that was irradiated under conditions
that are different from those in the regulation issued by FDA. This
group of letters states that human epidemiology studies should be
conducted to establish the safety of the use of radiation, and that
public hearings should be held. None of the letters included any
information to support this objection.
Because these submissions provided no information to support their
assertion regarding FDA's safety review, they provide no basis for FDA
to reconsider its decision to issue the poultry final rule. Moreover,
these submissions provide no basis for
[[Page 64104]]
granting a hearing because a hearing request must include specifically
identified reliable evidence that can lead to resolution of a factual
issue in dispute. A hearing will not be granted on the basis of mere
allegations or denials or general descriptions of positions and
contentions (Sec. 12.24(b)(2)). Therefore, FDA is denying the hearing
requested by these letters.
b. Objections by FWI. In one of its submissions, FWI contends that
``FDA has failed to demonstrate that there is a `reasonable certainty'
that irradiation of poultry at 300 krad [3 kGy] is not harmful, and
that therefore the Agency's approval is arbitrary and capricious.'' FWI
gives four reasons for its contention.
i. Power of the CIVO chronic rat feeding study. First, FWI raises
an issue about the statistical power of the chronic feeding study in
rats conducted by CIVO. Specifically, FWI asserts that this feeding
study was inadequate for determining safety because the study did not
have sufficient statistical power to demonstrate that the cancer risk
from consumption of irradiated chicken would be less than one in a
million. FWI stated: ``In accordance with procedures applied to food
additives generally, testing must be of such sensitivity that even a
small incremental risk of cancer cannot escape detection, namely one
per million, extrapolated to a typical human consumer.'' FWI provided
the results of statistical analyses regarding the power of the test. In
a background statement in its submission, FWI also stated that
``(g)iven the evidence that the formation of genotoxic radiolytic
products can and does occur, a petitioner seeking approval of
irradiation of poultry * * * should bear the burden of establishing the
magnitude of expected cancer risk, or that it is below a stated
level.'' In support of its objection, FWI submitted only a table
entitled ``Identification of Genotoxic Radiolytic Products in
Irradiated Organic Media or Food,'' but this table contained no
information on genotoxicity data from irradiated poultry. FWI's
objection did not dispute FDA's conclusion that the evidence
demonstrated that irradiated poultry was not mutagenic (55 FR 18538 at
18540).
Neither FDA's guidelines nor generally accepted scientific
procedures suggested for food additive testing recommend that
carcinogenicity testing be sufficiently sensitive to detect an
increased cancer risk of one in one million.\2\ FWI provided no
information to support its contention, either by reference to FDA's
regulations or to any other requirement. Thus, FDA concludes that this
objection raises no issue of fact that can be resolved at a hearing.
Instead, the objection simply states FWI's preference for a policy
regarding carcinogenicity testing. A hearing will not be granted on
issues of policy or law (Sec. 12.24(b)(1)).
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\2\ In fact, it would not be feasible to conduct such testing in
laboratory animals for substances ordinarily consumed at anything
other than trivially low levels in the diet. Generally, to increase
the power of a test one must increase the amount of test substance
fed or increase the number of animals in each group. For example,
the standard approach to assess low levels of carcinogenic risk is
to feed a substance in large amounts, determine the risk at such a
high dose, and extrapolate to lower doses using a linear
extrapolation model. Using such a model to detect an increased risk
of one in one million from a substance and assuming that the study
design could detect a 10 percent cancer incidence at a high dose,
one would have to feed an animal 100,000 times the amount it would
consume under realistic conditions. This clearly cannot be done with
a diet of chicken. Alternatively, testing thousands of animals per
group would overwhelm normal laboratory capabilities.
Under FDA guidelines, testing of a food additive is generally
conducted at levels no higher than 5 percent of the diet for
nonnutritive substances. This level can be higher for a nutritive
substance, however, provided it does not cause a significant
nutritional deficit (Ref. 1). As noted previously and discussed in
detail in the poultry final rule, the CIVO studies fed chicken
irradiated at the maximum dose allowed by the regulation, as well as
at twice that dose, in amounts equivalent to 35 percent of the diet
(by dry weight). Moreover, based on its review of the mutagenicity
data, FDA concluded that there was no basis to suspect that
irradiated chicken would be carcinogenic.
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In addition, FDA does not dispute FWI's contention that the
statistical power of this test is such that it cannot detect an
increased cancer risk of one in one million. However, FWI did not
demonstrate why prevailing on this factual issue would be adequate to
justify the action requested (Sec. 12.24(b)(4)).
Additionally, FWI suggested that to increase sensitivity of the
testing the radiation dose should have been increased tenfold or that
concentrated extracts of all radiolytic products formed by irradiating
chicken should have been fed.\3\ Once again, FWI submitted no
information to establish that the testing it recommended is required to
demonstrate safety, or even that such testing would be valid to assess
safety. Nor did FWI provide any information concerning how one can
conduct such a study or how one can interpret the findings in the
context of poultry irradiated at a dose not to exceed 3 kGy. Because
FWI provided no evidence to consider in support of its assertion, FDA
is denying the request for a hearing on this point because a hearing
will not be granted on the basis of mere allegations or denials or
general descriptions of positions and contentions (Sec. 12.24(b)(2)).
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\3\ Irradiation doses typically can be raised only marginally
higher than would be used in practice before they produce effects
that would change food significantly, often producing an unpalatable
product that animals will not eat. Special processing conditions can
be used to minimize such effects, however, such as irradiating food
in the frozen state in the absence of air. In the poultry final
rule, FDA cited tests conducted at a dose approximately 10 times
higher than the CIVO studies, which studies showed no adverse
effects related to irradiation (55 FR 18539 at 18540). FDA relied
primarily on the CIVO studies, however, because FDA would not expect
irradiation of poultry at a dose below 3 kGy to be conducted using
the processing conditions required for the higher dose.
Extracts of irradiated foods have not been relied on primarily
for testing because radiolytic products of food do not differ in any
particular chemical or physical properties from other components of
food that would allow them to be specifically extracted from food.
Additionally, radiolytic products are typically identical to
substances that occur naturally in foods. Therefore, FDA is not
aware of how one could prepare an extract that would ensure the
presence of all radiolytic products while excluding the presence of
other similar components of food that did not result from
irradiation. The only way to ensure that all radiolytic products are
present is to feed the irradiated food itself.
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ii. Addition of ethoxyquin to irradiated chicken in the CIVO
studies. In the CIVO studies, the researchers removed water from the
chicken by drying over hot air, in order to preserve the chicken for
the time needed to complete the testing. Prolonged contact with hot air
causes lipids (fats) to be oxidized to lipid peroxides, thereby
rendering the food rancid and unpalatable. Prolonged storage can also
lead to rancidity. Thus, the researchers added ethoxyquin, an
antioxidant, to the chicken to prevent rancidity. Preventing rancidity
by this means is of importance for a product dried and stored, as in
the test.
In its second contention, FWI states that the CIVO studies were
seriously compromised because the addition of the antioxidant
ethoxyquin to the chicken decreased the levels of lipid peroxides in
the irradiated chicken to levels comparable to those in unirradiated
chicken. FWI contends that these decreased levels would interfere with
the observation of toxicity from the lipid peroxides that were formed
in higher amounts during the hot air drying of irradiated chicken than
in the unirradiated chicken.
In the poultry final rule, FDA noted that ethoxyquin had been
incorporated into both the control diets and the test diets in the CIVO
studies. The agency acknowledged (55 FR 18538 at 15839 and 15840) that
FDA reviews of the CIVO studies had raised the question of
[[Page 64105]]
whether the addition of ethoxyquin could compromise the study and that
this issue needed to be resolved before FDA could reach a safety
decision. After careful consideration, FDA concluded that the addition
of ethoxyquin to prevent rancidity of the chicken fat did not confound
the results of the study.
The effect of ethoxyquin is to retard, during storage, the normal
oxidation to peroxides of the fatty content of the diet. Importantly,
ethoxyquin cannot reverse oxidation that has already taken place. In
the CIVO studies, ethoxyquin was added after irradiation of the meat.
Therefore, its presence would not alter the effects of radiation on the
food (including any potential effects on the formation of lipid
peroxides), as might occur if ethoxyquin had been added beforehand and
were present during irradiation.\4\
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\4\ Moreover, ethoxyquin would not be needed for poultry
irradiated and stored under typical commercial conditions.
Commercial needs would require processing and storage practices that
would prevent development of rancidity in order to provide a
marketable product. Thus, the agency does not expect that high
levels of lipid peroxides will be present in foods that are sold for
human consumption.
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FWI did not dispute FDA's explanation in the final rule as to why
addition of ethoxyquin did not compromise the CIVO studies, and
provided no information to contradict the agency's conclusion. Further,
FWI did not show that FDA failed to consider important information that
would have altered the agency's conclusion on this issue. Therefore,
FDA is denying this objection and request for a hearing because a
hearing will not be held if there is no factual issue that can be
resolved by available and specifically identified reliable evidence
(Sec. 12.24(b)(2)).
iii. Adequacy of all CIVO studies--other issues. In its objection,
FWI also refers to
``* * * additional concerns regarding all the CIVO studies (storage of
the irradiated chicken for periods far in excess of those anticipated
for human consumers; possibly excessive supplementation of diets with
vitamins A and E) and for the chronic feeding study in particular as
noted in memoranda provided by the FDA * * *.'' FWI submitted no
information to substantiate these concerns. FWI stated, however, that
the short amount of time available to file objections following
issuance of the poultry final rule precluded a detailed examination of
the issues raised by these studies.\5\
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\5\ With respect to the limited time available for objections,
FDA notes that the notice of filing for FAP 8M3422, which petition
contained these studies, was published more than 3 years prior to
FDA's decision. Thus, all safety information in the petition,
including the CIVO studies, was available to FWI under the Freedom
of Information Act for a significant period of time (21 CFR
171.1(h)(1)).
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FDA is denying FWI's request for a hearing to the extent that it is
based on these particular contentions because FWI's request identified
no particular factual issue in dispute and also because FWI provided no
specific evidence that could be considered at such a hearing. As noted,
a hearing will not be granted on the basis of mere allegations or
descriptions of positions or contentions (see Sec. 12.24(b)(1) and
(b)(2)).
iv. Compliance with the Bureau of Foods Irradiated Food Committee
(BFIFC) report of 1980. Finally, FWI asserts that the irradiated
poultry final rule did not comply with all the recommendations of the
BFIFC report issued in 1980. FWI also expressed disagreement with
recommendations in that report.
The BFIFC report is an internal document prepared by FDA scientists
that provides recommendations for evaluating the safety of irradiated
foods based on the known effects of radiation on foods and on the
capabilities of toxicological testing. The report was made available to
the public for comment in the Federal Register of March 27, 1981 (46 FR
18992). While the report and the comments received on it have aided
FDA's thinking regarding the safety testing of irradiated foods, the
report established no requirements. FDA cited the BFIFC report in a
footnote in the poultry final rule (55 FR 18538 at 18541) to illustrate
how the toxicological data the agency considered (much of which was
submitted before issuance of the BFIFC report) compared to the
recommendations in the report.
Consistent with section 409 of the act, FDA's decision on the
safety of irradiation of poultry was based on the entire record of that
proceeding. Further, as discussed in the poultry final rule, in
reaching its conclusion that irradiation of poultry under conditions
specified in the regulation does not present a toxicological hazard (55
FR 18538 at 18541), FDA evaluated both studies submitted in the
petitions as well as other studies of irradiated chicken available in
agency files. Although FWI alleged that some of the studies that FDA
evaluated did not comply with recommendations in the BFIFC report, FWI
did not present any evidence that these alleged inconsistencies, even
if true, would have led to a different conclusion concerning the safety
of irradiation of poultry. Therefore, FDA is denying this objection and
request for a hearing because it raises no factual issue that, even if
resolved in the way sought by the objection, would justify the action
requested (Sec. 12.24(b)(4)).
B. Environmental Issues
1. FDA's Finding of No Significant Impact
In reaching its decision to permit the irradiation of poultry at up
to 3 kGy, the agency carefully considered the environmental effects of
this action, as required under the National Environmental Policy Act
(NEPA). After carefully reviewing the environmental assessment (EA)
submitted by FSIS for FAP 7M3974 and environmental information
submitted by RTI for FAP 8M3422, FDA concluded that this particular
action would not have a significant impact on the human environment,
and that an environmental impact statement was not required. The
agency's FONSI and the evidence supporting it, including material from
both the FSIS' EA and the submissions from RTI, were placed on display
at FDA's Dockets Management Branch.
A key element in the EA and in FDA's FONSI is the regulatory
controls exerted by various regulatory bodies, such as the Nuclear
Regulatory Commission (NRC), the Occupational Safety and Health
Administration, the Department of Transportation, the Environmental
Protection Agency, FDA itself, and various State and local authorities.
These controls are designed to ensure that any substances that may be
lawfully emitted into the environment will not pose a significant
environmental impact. These controls and regulations were cited in the
materials considered by FDA, which material formed the basis of its
FONSI.
2. Objections by FWI
In its second objection, FWI contends that FDA's FONSI is
``inadequate.'' FWI requested the preparation of an Environmental
Impact Statement (EIS) and an open public hearing on the existing and
potential dangers of the irradiation industry. Specifically, FWI
maintained that the agency's FONSI is inadequate because it:
* * * relies strictly on information submitted by those who
stand to gain from the approval of poultry irradiation; * * *
extensively cites materials submitted by Martin Welt, a convicted
felon with a criminal record of deceiving federal regulatory
agencies; * * * completely disregards the fact that there have
already been numerous irradiation accidents and, thus, must be
deemed inadequate.
The objection also states that:
In documents released by FSIS within the past year, initially
there is no mention of
[[Page 64106]]
irradiation as a potential research area; and then, later, the FSIS
declares that alternatives to the irradiation solution need not be
discussed when considering the environmental impact of the
technology. This contradiction alone warrants a hearing and should
prove the need for a full Environmental Impact Statement.
Finally, the objection also requested an extension of the comment
period, asserting that:
FDA; * * * received the original petition (FAP 7M3974) seeking
approval for poultry irradiation in February, 1977 [sic] and, thus,
it has taken your agency more than 13 years to come to your final
decision. You are now granting the public a mere 30 days to comment
on a ruling that took your agency more than 13 years to decide upon.
FDA notes that FWI misinterprets the statutory 30-day objection
period, which is specified in section 409(f) of the act, as an
opportunity for comment. The poultry final rule issued in the Federal
Register of May 2, 1990, was a final rule and the opportunity for
comment ended at that time. As noted in section I of this document, the
agency had announced in the Federal Register of February 20, 1987, the
filing of FAP 7M3974 and the filing of FAP 8M3422 in the Federal
Register of March 3, 1987. Thus, FWI had notice of the filing of the
petitions and had ample time to comment. The time to submit objections
is established by statute (section 409(f) of the act), and thus, is not
a deadline established by FDA. However, because the submission from FWI
was submitted within the objection period, FDA is considering it as an
objection.
In the following discussion, FDA addresses each of FWI's points
outlined previously, as well as the data and information filed in
support of each, comparing each to the standards for a hearing in
Sec. 12.24.
a. Information submitted by interested parties. The mere fact that
information has been submitted by a party with an interest in an issue
under agency consideration is not sufficient reason to reject that
information.\6\ In fact, each petitioner is required by FDA regulations
to submit an EA as part of its food additive petition unless the action
sought by the petitioner qualifies for a categorical exclusion. In
assessing the potential environmental impact that could result from the
approval of use of a food additive, including the use of sources of
radiation in food processing, FDA critically evaluates the information
submitted in the petitioner's EA, consistent with the applicable agency
regulations (part 25 (21 CFR part 25)).
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\6\ Moreover, the agency notes that, the USDA, one of the
petitioners, does not stand to gain from the approval of poultry
irradiation, contrary to FWI's contention that the environmental
information was submitted by those who do.
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FWI has failed to submit any evidence that would call into question
the validity of any of the specific information submitted by the
petitioners and relied upon by FDA. FWI is merely asserting its opinion
that an EA submitted by a petitioner is inherently inadequate.
Accordingly, the agency is denying FWI's request for a hearing because
a hearing will not be granted on issues of policy or law
(Sec. 12.24(b)(4)), nor will one be granted on the basis of mere
allegations or denials or general descriptions of positions or
contentions (Sec. 12.24(b)(1)).
b. Petitioner convicted of crimes. In its objection, FWI also
contends that the agency's FONSI is inadequate because ``* * * it
extensively cites materials submitted by Martin Welt, a convicted felon
with a criminal record of deceiving federal regulatory agencies.'' FWI
did not provide any specific information to question the reliability or
accuracy of the environmental information contained in FAP 8M3422\7\ or
FAP 7M3974. To support its objection, FWI submitted a copy of the
government's sentencing memorandum in United States v. Welt, Criminal
#88-87, U.S. District Court, District of New Jersey, 1988, (dated
August 30, 1988, from Samuel A. Alito, Jr., United States Attorney, to
the Honorable Maryanne Trump Barry, United States District Court,
District of New Jersey, with attachments).
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\7\ Dr. Martin Welt was the president of RTI when it submitted
FAP 8M3422. As the responsible company official, he signed the
environmental information submitted in that petition. At the time
FDA issued its final rule, Dr. Welt was no longer part of RTI
management.
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A food additive regulation is a conclusion that use of the additive
in compliance with the conditions of use specified in such regulation
is safe; a food additive regulation is not a license for an individual
petitioner. Similarly, the FONSI is a conclusion that use of the
additive under the proposed conditions of use, which includes
compliance with applicable Federal, State, and local regulations, will
not result in a significant impact on the human environment. The fact
that Martin Welt (once the president of one of the petitioners) is a
convicted felon is not in dispute. However, Dr. Welt's status is wholly
irrelevant to the agency's evaluation of the potential environmental
impact of the poultry final rule. FDA evaluated the environmental
information supplied by RTI and the EA submitted by FSIS in an
independent, scientific and critical fashion. It is the quality of the
data and conclusions drawn from the information provided that are
important. FWI raised no allegation as to the accuracy or credibility
of the submitted information, nor did it identify any information FDA
ignored or misinterpreted in issuing its FONSI. Accordingly, FDA is
denying FWI's request for a hearing on this issue because a hearing
will not be granted on factual issues that are not determinative to the
action requested (see Sec. 12.24(b)(4)).
c. Accidents at irradiation facilities. FWI also objected to the
agency's FONSI on the grounds that the EA prepared by USDA ``fails to
mention the numerous irradiation accidents which have already occurred
in the U.S.--many of which have resulted in environmental, worker and
product contamination.'' FWI contends that should the poultry industry
widely adopt the use of irradiation, the need for irradiation
facilities will be greatly expanded and that there are additional risks
inherent in such an expanded irradiation industry. In support of its
objection, FWI submitted the following:
1. A document entitled ``Fact Sheet--Radiation Sterilizers, Inc.
(RSI) Incident, prepared by James L. Setser.''
2. A document entitled ``Summary--First Interim Report of the RSI
Incident Evaluation Task Force,'' June 1989.
3. A document entitled ``Statement Before the Incident Evaluation
Task Force for the Governor of Georgia,'' prepared by Judith H.
Johnsrud, Research Director, Food and Water, Inc., October 17, 1988.
4. A list of ``Irradiation incidents at large scale gamma
irradiation facilities, 1974 to 1988,'' compiled by Brion Sprinsock,
National Coalition to Stop Food Irradiation.
5. A transcript of the morning session of the U.S. Nuclear
Regulatory Commission Irradiator Workshop held on May 24, 1988.
FDA's action in issuing a food additive regulation permitting the
irradiation of poultry at up to 3 kGy allows licensed irradiation
processors to include poultry among the products treated at their
facilities. Such irradiation of poultry is subject, however, to all
applicable regulations, including local, State, and Federal safety
regulations. FDA's FONSI is a statement that irradiation of poultry, in
compliance with all applicable regulations, will not have a significant
impact on the environment. It is entirely reasonable for FDA to
evaluate the environmental effects of this food additive approval on
the basis that facilities will operate in compliance with applicable
safety rules. To assume that facilities will not operate in such
[[Page 64107]]
compliance would be highly speculative and essentially be a requirement
that FDA perform a worst-case analysis when evaluating the potential
environmental impact of an agency action. This is simply not what NEPA
requires (see Robertson v. Methow Valley Citizens Council, 490 U.S.
332, 355 (1989)).
Importantly, the poultry final rule, in and of itself, does not
permit any additional building or operation of irradiation facilities,
and thus, does not directly result in any increased risk of accidents
at such facilities. Before an irradiation facility is built, other
regulatory agencies with oversight regarding its site design, location,
licensing, and radiation control procedures (such as the NRC) must
issue permits. The evaluation of the environmental impact of the
construction and operation of these facilities is, under NEPA, the
responsibility of the licensing agency or agencies. FDA's environmental
evaluation in this case, and thereby FDA's FONSI, was not intended to
reassess the environmental impact issues that are the responsibility of
other regulatory agencies. In fact, under NEPA, an agency is not
required to assess the environmental impact of a portion of a project
where a second agency has jurisdiction over such portion (see State of
N.C. v. City of Virginia Beach, 951 F.2d 596 (4th Cir. 1991)).
Accordingly, even if there have been accidents at irradiation
facilities, or even if there would be an increased risk of such
accidents as a result of the poultry final rule, these facts have no
bearing on FDA's EA of its action. Thus, FDA is denying a hearing on
this issue because a hearing will not be granted on factual issues that
are not determinative with respect to the action requested
(Sec. 12.24(b)(4)).
d. Alleged contradiction. FWI also objects to FDA's FONSI on the
grounds of an alleged contradiction between information in FSIS's EA
and other FSIS documents and cites an article from The Food and Drug
Letter (April 28, 1989) in support of its objection. According to FWI,
FSIS declared in its EA that alternatives to irradiation need not be
discussed when considering the environmental impact of the technology
and yet, in the article in The Food and Drug Letter, did not mention
irradiation as one of the research areas for potentially solving the
bacterial problem.
The material cited by FWI does not support its contention. In
preparing an EA, petitioners are required, under Sec. 25.31a(a)(11), to
consider alternatives to the proposed action if potential adverse
environmental impacts have been identified for the proposed action
(Sec. 25.31a(a)(11)). After evaluating the FSIS' EA, the agency found
that irradiation of poultry in compliance with existing laws and
regulations will not lead to a significant impact on the environment.
Because no adverse impacts are expected, the agency did not require,
and FSIS did not address, alternatives to the proposed action under
format item 11 of the EA. It should also be noted that, contrary to
FWI's contention, FSIS did not claim in its EA that irradiation is the
only solution to food-borne pathogens.
The article referred to by FWI from The Food and Drug Letter
discusses areas identified by FSIS for future research for potential
solutions to the problem of microbial contamination in poultry; at that
time, irradiation had already been a subject of research as a potential
solution to this problem. Thus, there is no contradiction between the
statements made by FSIS in its EA and in the article in The Food and
Drug Letter.
In order to justify a hearing on this issue, FWI would need to
provide credible evidence that challenges FDA's conclusion that the
irradiation of poultry in compliance with existing regulations will not
lead to a significant impact on the environment (see Sec. 12.24(b)(2)).
FWI has not done so and, thus, has failed to meet a threshold burden of
tendering evidence that suggests a need for a hearing (Costle v.
Pacific Legal Foundation, supra, 445 U.S. at 214).
V. Summary and Conclusions
The safety of poultry irradiated at up to 3 kGy has been thoroughly
tested and the data have been reviewed by the agency. As discussed
previously, FDA concluded that the available studies establish the
safety of poultry irradiated at doses up to 3 kGy for human
consumption.
The petitioner has the burden to demonstrate safety before FDA can
approve the use of a food additive. Nevertheless, once the agency makes
a finding of safety in an approval document, the burden shifts to an
objector, who must come forward with evidence that calls into question
FDA's conclusion (American Cyanamid Co. v. FDA, 606 F2d. 1307, 1314-
1315 (D.C. Cir. 1979)).
None of those objecting to the final rule has identified any
information in the record that was misconstrued by FDA to support the
objector's claim that the agency incorrectly concluded that consumption
of poultry irradiated at up to 3 kGy is safe. Nor has any objector
established that the agency overlooked significant information in
reaching its conclusion. Indeed, none of the objections presented any
relevant evidence that has not already been carefully reviewed and
weighed by the agency. The agency has determined that the objections do
not raise any genuine and substantial issue of fact that would justify
an evidentiary hearing on any of the objections raised (Sec. 12.24(b)).
Accordingly, FDA is overruling the objections and is denying the
requests for a hearing. In addition, FWI's request for a stay of the
effectiveness of the May 2, 1990, regulation until a hearing is held is
moot because FDA is denying all hearing requests.
FDA is confirming May 2, 1990, as the effective date of the
regulation.
VI. Reference
The following reference has been placed on display in the Dockets
Management Branch (HFA-305), Food and Drug Administration, 12420
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA, Bureau of Foods, ``Toxicological Principles for the
Safety Assessment of Direct Food Additives and Color Additives Used
in Food,'' Appendix III, p. 18, 1982.
Dated: November 26, 1997.
Michael A. Friedman
Lead Deputy Commissiner for the Food and Drug Administration.
[FR Doc. 97-31739 Filed 12-2-97; 8:45 am]
BILLING CODE 4160-01-F
