[Federal Register Volume 62, Number 3 (Monday, January 6, 1997)]
[Rules and Regulations]
[Pages 611-613]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 579

[Docket No. 92F-0317]


Food Additives; Irradiation in the Production, Processing, and 
Handling of Animal Feed and Pet Food; Ionizing Radiation for Treatment 
of Poultry Feed or Poultry Feed Ingredients

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections and denial of requests for a 
hearing.

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SUMMARY: The Food and Drug Administration (FDA) is responding to 
objections and is denying the requests for a hearing on the final rule 
that amended the food additive regulations (animal use) to provide for 
the safe use of gamma radiation from cobalt-60 for rendering complete 
poultry feeds or poultry feed ingredients salmonella negative. Four 
parties filed objections to the final rule and submitted requests for a 
hearing requesting approval of additional energy sources for this use. 
After reviewing their submissions, FDA has concluded that the 
objections do not raise issues of material fact concerning the approval 
that justify granting a hearing. Therefore, FDA is denying the requests 
for a hearing.

DATES: The final rule published in the Federal Register of September 
28, 1995, at 60 FR 50098 is effective.
FOR FURTHER INFORMATION CONTACT: George Graber, Center for Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1724.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In a notice published in the Federal Register of August 20, 1992 
(57 FR 37825), FDA announced that a food additive petition (animal use) 
(FAP 2216) had been filed by Nordion International, Inc., 447 March 
Rd., P.O. Box 13500, Kanata, ON, Canada K2K lX8. The petition proposed 
that the feed irradiation regulations be amended to provide for the 
safe use of gamma radiation from cobalt-60, not to exceed 25 kiloGrays 
(kGy) (2.5 Mrad), to control salmonella in complete poultry (chickens, 
turkeys, ducks, geese, cornish hens, pheasant, quail, and fowl) feeds 
or feed ingredients. The notice of filing of FAP 2216 provided for a 
60-day comment period. No comments were received.
    In a final rule published in the Federal Register of September 28, 
1995 (60 FR 50098), FDA amended the animal feed and pet food 
irradiation

[[Page 612]]

regulations to provide for the use of 2 to 25 kGy of gamma radiation 
from sealed units of cobalt-60 to render complete poultry feeds or 
poultry feed ingredients salmonella negative. The rule added new 
Sec. 579.40 (21 CFR 579.40) to reflect the new feed additive use.

II. Objections and Requests for a Hearing

    AECL Technologies, Inc., AECL Accelerators, 20 Little Lane, 
Hauppage, NY 11788; E-BEAM Services, Inc., 32 Melrich Rd., Cranbury, NJ 
08512; Department of Animal Sciences, Texas A&M University, College 
Station, TX 77843-2471; and Secretariat of the International 
Consultative Group on Food Irradiation; each filed objections to the 
final rule citing failure of that rule to provide for additional energy 
sources including gamma rays from cesium-137, machine generated 
electrons not to exceed 10 million electron volts, and machine 
generated x-rays not to exceed 5 million electron volts, in addition to 
the use of gamma radiation from cobalt-60. The petition supported use 
of cobalt-60 energy sources. Information filed in the objections did 
not object to the conditions of approval of the petition, but the 
information filed in the objections supported additional energy sources 
not previously considered. Such information should be the subject of a 
separate food additive petition filed in accordance with 21 CFR 571.1 
to support amending the regulations to provide for the use of these 
additional energy sources.

III. Standards for Granting a Hearing

    Section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 348(b)(5)) provides for publication of a notice, in 
general terms, of filing of a food additive petition. That notice 
contains provisions for a 60-day comment period. Section 409(f)(1) of 
the act provides for a 30-day comment period after publication of an 
order (final rule) relating to approval of a food additive petition to 
permit any person adversely affected by such an order to file 
objections, specifying with particularity the provisions of the order 
``deemed objectionable, stating reasonable grounds therefor,'' and 
requesting a public a hearing upon such objections.
    Specific criteria for determining whether a request for a hearing 
is justified are set forth in Sec. 12.24(b) (21 CFR 12.24(b)). A 
hearing will be granted if the material submitted shows that:
    (1) There is a genuine and substantial issue of fact 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 person. A hearing will be denied if 
the Commissioner concludes that the data and information submitted 
are insufficient to justify the factual determination urged, even if 
accurate.
    (4) Resolution of the factual issue in the way sought by the 
person is adequate to justify the action requested. A hearing will 
not be granted on factual issues that are not determinative with 
respect to the action requested, e.g., if the Commissioner concludes 
that the action would be the same even if the factual issue were 
resolved in the way sought * * *.
    (5) The action requested is not inconsistent with any provision 
in the act or any regulation in this chapter particularizing 
statutory standards. The proper procedure in those circumstances is 
for the person requesting the hearing to petition for an amendment 
or waiver of the regulation involved.
    (6) The requirements in other applicable regulations, e.g., 
Secs. 10.20, 12.21, 12.22, 314.200, 314.300, 514.200, and 601.7(a), 
and in the notice promulgating the final regulation or the notice of 
opportunity for hearing are met.
    FDA may deny a request for a hearing if the objections to the 
regulation do not raise genuine and substantial issues of fact that can 
be resolved at a hearing (Community Nutrition Institute v. Young, 773 
F.2d 1356, 1364 (D.C. Cir. 1985), cert. denied, 475 U.S. 1123 (1986)).
    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. 1982)). If a request for a hearing fails to 
identify any factual evidence that would be the subject of a hearing, 
then there is no basis for holding a hearing. 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.
    A hearing request must not only contain evidence, but that evidence 
should raise a material issue of fact upon 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).)
    In sum, a hearing request should present sufficient credible 
evidence to raise a material issue of fact, and that evidence must be 
adequate to resolve the issue as requested and to justify the action 
requested.

IV. Analysis of Objections and Response to Requests for a Hearing

    FDA is denying the parties' request for a hearing on their 
objections for two reasons. First, under Sec. 12.24(b)(5), FDA will not 
grant a hearing if the action requested is inconsistent with any 
provision in the act or any FDA regulation. The parties' requested 
action is inconsistent with the act and FDA's regulations, because the 
parties have raised an issue regarding additional energy sources for 
this food additive use that was not previously presented in the 
petition and have requested a hearing on the issue. Under the act and 
FDA's regulations, the scope of a proceeding for approval of a food 
additive use is limited to the terms and conditions of use set forth in 
the petition.
    Under section 409(c) of the act, an action on a petition to 
establish a food additive use is based on the petition and other 
available information. The petition that led to the issuance of 
Sec. 579.40 provided for use of gamma radiation from a cobalt-60 energy 
source for rendering complete poultry feeds or poultry feed ingredients 
salmonella

[[Page 613]]

negative. FDA granted this petition, and in the preamble of the final 
rule (60 FR 50098), the agency specifically addressed each of the 
issues raised in evaluating the petition. The parties, however, have 
objected to the failure of the final rule to provide for additional 
energy sources, including gamma rays from cesium-137, machine generated 
electrons not exceeding 10 million electron volts, and machine 
generated x-rays not exceeding 5 million electron volts.
    Under section 409(f)(1) of the act, any person adversely affected 
by a final rule may file objections thereto, specifying with 
particularity the provisions of the final rule deemed objectionable, 
stating reasonable grounds therefor, and requesting a public hearing 
upon such objections. However, there is nothing in the act or in FDA's 
regulations that suggests or implies that, or that authorizes, 
interested persons to use the opportunity to object as an opportunity 
to expand the authorized use of a food additive beyond that use sought 
in the petition. On the contrary, 21 CFR 571.6 requires that if, after 
a petition has been filed, the petitioner submits added information 
which constitutes a substantive amendment, the petition will be given a 
new filing date; and the review process will begin anew.
    Thus, under the act and FDA's regulations, the scope of a 
proceeding for approval of a food additive use is limited to the terms 
and conditions of use set out in the petition. To the extent that a 
person who is not the petitioner seeks to extend the petitioned-for 
terms and conditions of use, the person must do so by a separate 
petition, not by objection to the final rule. To attempt to do so by 
objection to the final rule, or by comment on the notice of filing, is 
to attempt to act in a manner that is inconsistent with the act and 
FDA's regulations. The proper procedure, as stated in Sec. 12.24(b)(5), 
is for the objecting parties to petition for amendment of Sec. 579.40. 
Thus, the objecting parties have failed to justify a hearing on the 
requested action.
    Second, under its regulations, FDA will not grant a hearing on the 
basis of mere allegations (Sec. 12.24(b)(2)). Consistent with this 
regulation, the relevant case law provides that where a party 
requesting a hearing only offers allegations without an adequate 
proffer to support them, the agency may properly disregard those 
allegations (General Motors Corp. v. FERC, 656 F.2d 791, 798 n.20 (D.C. 
Cir. 1981)). The objecting parties have failed to submit any evidence 
showing that failure to approve the use of additional energy sources 
will compromise the approved use of radiation emitted from cobalt-60. 
Thus, because the parties have failed to offer any support for their 
allegation, FDA concludes that this objection does not justify a 
hearing.

V. Summary and Conclusion

    The agency is denying the objections and the requests for a hearing 
on the basis that the request is beyond the scope of the petitioned 
action and is appropriately resolved through the submission of a 
separate petition (Sec. 12.24(b)(5)) and the requested action could not 
be approved on the basis of a hearing, i.e., not to be granted based on 
allegations or general descriptions of positions and contentions 
(Sec. 12.24(b)(2)).
    The filing of the objections and requests for a hearing does not 
affect the provisions of Sec. 579.40 to which the objections were made.
    In the absence of any other objections and requests for a hearing, 
the agency further concludes that this document constitutes final 
action on the objections and requests for a hearing received in 
response to the regulation as prescribed in section 409(f)(1) of the 
act (21 U.S.C. 348).
    Therefore, under the Federal Food, Drug, and Cosmetic Act (sec. 409 
(21 U.S.C. 348)) and under authority delegated to the Commissioner of 
Food and Drugs (21 CFR 5.61), notice is given that the objections and 
the requests for a hearing filed in response to the final rule 
Sec. 579.40 that was published in the Federal Register on September 28, 
1995 (60 FR 50098), do not form a basis for further amendment of this 
final rule.

    Dated: December 30, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-137 Filed 1-3-97; 8:45 am]
BILLING CODE 4160-01-F