[Federal Register Volume 60, Number 211 (Wednesday, November 1, 1995)]
[Rules and Regulations]
[Pages 55446-55448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-27033]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 87C-0316]


Listing of Color Additives Exempt From Certification; Astaxanthin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objection and denial of the request for 
a hearing; removal of stay for certain provisions.

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SUMMARY: The Food and Drug Administration (FDA) is responding to an 
objection and is denying the request that it has received for a hearing 
on the final rule that amended the color additive regulations to 
authorize the use of astaxanthin as a color additive in the feed of 
salmonid fish to enhance the color of their flesh. The objection 
concerns a specification and the requirement for labeling of salmonid 
fish that have been fed feeds that contain the color additive. After 
reviewing the objection to the final rule, the agency has concluded 
that the objection does not raise issues of material fact that justify 
granting a hearing. The agency also is establishing a new effective 
date for these two provisions of this color additive regulation, which 
were stayed by a document that published on August 14, 1995.

EFFECTIVE DATE: 21 CFR 73.35(b) and (d)(3), previously stayed (60 FR 
41805, August 14, 1995) because of an objection regarding a 
specification and a labeling requirement, respectively, are effective 
November 1, 1995.

FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food 
Safety and Applied Nutrition (HFS-217), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-418-3078.

SUPPLEMENTARY INFORMATION:

 I. Introduction

    -In the Federal Register of April 13, 1995 (60 FR 18736), FDA 
issued a final rule permitting the use of astaxanthin as a color 
additive in the feed of salmonid fish to enhance the color of their 
flesh. This regulation, codified at 21 CFR 73.35, was issued in 
response to a color additive petition filed by Hoffmann-La Roche, Inc., 
in the Federal Register of December 2, 1987 (52 FR 45867). In the 
preamble to the final rule, FDA discussed the safety basis for the 
agency's decision to list this use of astaxanthin and responded to 21 
letters containing comments to the petition.

 II. Objections and Requests for a Hearing

    -A manufacturer filed a timely objection to two provisions of the 
regulation and requested a formal evidentiary hearing on the issues 
raised in its objection. The manufacturer sought to amend the 
specifications for astaxanthin, specifically requesting that the 4 
percent specification for carotenoids other than astaxanthin be changed 
to 40 percent. The manufacturer also sought to amend the labeling 
requirements for astaxanthin by removal of the requirement to label the 
presence of the color additive, in accordance with Secs. 101.22(k)(2) 
and 101.100(a)(2) (21 CFR 101.22(k)(2) and 101.100(a)(2)), in salmonid 
fish that were fed feeds containing astaxanthin. The agency announced 
the stay of the two affected paragraphs of the regulation, namely Sec.  
75.73(b) and (d)(3), in the Federal Register of August 14, 1995 (60 FR 
41805). In that document the agency confirmed the effective date of May 
16, 1995, for the remainder of the regulation.

 III. Standards for Granting a Hearing

    -Sections 701(e)(2) and 721(d) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 371(e)(2) and 379e(d)) provide that, 
within 30 days after publication of an order relating to a color 
additive regulation, any person adversely affected by such an order may 
file objections, specifying with particularity the provisions of the 
order ``deemed objectionable, stating the grounds therefor,'' and 
requesting 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 Community Nutrition Institute v. Young, 773 F.2d 1356, 1364 
(D.C. Cir. 1985), cert. denied, 475 U.S. 1123 (1986).
    -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 by the requester 
shows that:

[[Page 55447]]

     (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 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., 21 
CFR 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 a hearing are met.
     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 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.
    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).
    In sum, a hearing request should 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

    -In its objection, the manufacturing company raised two specific 
issues concerning the agency's final rule for astaxanthin and requested 
hearings on each issue raised by the objection. In the preamble to the 
final rule (60 FR 18736), the agency specifically addressed each of the 
issues raised by this company.
    The company's first objection is to the specification in the final 
rule for total carotenoids other than astaxanthin of 4 percent. The 
company stated that this particular specification is not necessary or 
appropriate to assure the identity or the safe use of astaxanthin, and 
that it is unreasonable when applied to astaxanthin made from natural 
sources such as the yeast Phaffia rhodozyma, krill, or crayfish shells. 
The company stated that at the hearing it would show that a 
specification of 40 percent or more for total carotenoids other than 
astaxanthin would be appropriate.
    FDA is denying the company's request for a hearing on this 
objection under Sec. 12.24(b)(5), in that the request is inconsistent 
with the act and FDA's regulations. Under section 721(d) of the act, a 
proceeding for the issuance of a color additive regulation is 
instituted by the filing of a petition. The petition that led to the 
issuance of Sec. 73.35 (21 CFR 73.35) sought a specification for total 
carotenoids other that astaxanthin of 4 percent. FDA granted that 
aspect of the petition.
    Under section 701(e)(2) of the act, a person who will be adversely 
affected by the agency's action on the petition may object thereto. 
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 beyond those sought in the petition. On the contrary, 21 CFR 
70.19(i) requires that a request for an amendment of a color additive 
listing regulation be accompanied by a deposit of $1,800.00.
    Thus, under the act and FDA's regulations, the scope of a 
proceeding for the listing of a color additive is limited to the terms 
and conditions of use set out in the petition. To the extent that a 
person seeks to extend the petitioned-for terms and conditions of use, 
the person must do so by separate petition, not by objection to the 
final rule. To attempt to do so by objection (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. Therefore, FDA is denying a hearing 
on this issue. The proper procedure, as stated in Sec. 12.24(b)(5), is 
for the company to petition for amendment of Sec. 73.35.
    -The company's second objection is to the requirement that the 
presence of the color additive be declared on the labels of salmonid 
fish that have been fed feeds containing the astaxanthin color 
additive. In support of its objection, the company states that the 
labeling requirement would be misleading and would place fish farming 
operations at an unfair disadvantage when competing with the produce of 
ocean or river fishing. The company contends that every salmon with 
pink flesh has eaten in its diet foods containing astaxanthin. The 
company also contends that both types of salmon, whether grown in 
aquaculture or harvested from the ocean, contain astaxanthin that 
colors their flesh pink. Thus, the company asserts that the FDA-
required astaxanthin labeling of aquacultured fish containing 
astaxanthin will mislead the public into believing that these two types 
of fish are different, and that salmon from aquaculture contain a 
substance not present in normal salmon.
    -FDA is denying a hearing on this issue for two reasons. First, 
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 

[[Page 55448]]
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 company failed to submit any evidence to support 
its assertion that requiring the label of salmonid fish fed feeds that 
contain astaxanthin to declare that color has been added will mislead 
the public or will cause consumers to believe that fish so labeled are 
somehow different from other fish. Thus, because it has not proffered 
support for its allegation, the company has not justified a hearing on 
this issue.
    -Second, under Sec. 12.24(b)(4), this assertion would not justify a 
hearing even if the company had made a proper proffer because 
declaration of the color additive is required as a matter of law on the 
label of fish that have been colored with it. Under Sec. 101.22(k), the 
label of a food to which any coloring has been added shall declare the 
presence of the coloring in the statement of ingredients. Section 
101.22(k) incorporates the provisions of section 403(k) of the act (21 
U.S.C. 343(k)) into FDA's regulations.
    -Under Sec. 101.22(a)(4), a coloring is any ``color additive'' as 
defined in Sec. 70.3(f) (21 CFR 70.3(f)). Under Sec. 70.3(f), a 
legislative regulation that was adopted after notice and comment 
rulemaking (28 FR 6439, June 22, 1963), ``color additive'' includes an 
ingredient of an animal feed whose intended function is to impart, 
through the biological processes of the animal, a color to the meat, 
milk, or eggs of the animal. Thus, as matter of law, astaxanthin is a 
color additive whose presence in salmonid fish that have been fed feeds 
that contain this color additive must be declared in the label or 
labeling of the fish. (Sections 101.22(k)(2) and 101.100(a)(2) of FDA's 
regulations describe how this declaration is to be made). On this 
basis, FDA concludes that this objection has no legal merit and does 
not justify a hearing.

V. Summary and Conclusion

    The agency is denying the objection and the request for a hearing 
on the following: (1) The specification for carotenoid content of 
astaxanthin under Sec. 73.35(b) on the basis that the request is beyond 
the scope of the petitioned action for astaxanthin and is appropriately 
resolved through the submission of a petition (Sec. 12.24(b)(5)); and 
(2) the labeling requirement for astaxanthin under Sec. 73.35(d)(3) on 
the basis that a hearing will not be granted based on mere allegations 
or general descriptions of positions and contentions 
(Sec. 12.24(b)(2)), and that, even if an appropriate proffer had been 
made, the objection is not determinative of the issue raised 
(Sec. 12.24(b)(4)).
    The filing of the objection and request for hearings served to stay 
automatically the effectiveness of the two provisions of Sec. 73.35 to 
which the objections were made. Section 701(e)(2) of the act states: 
``Until final action upon such objections is taken by the Secretary * * 
*, the filing of such objections shall operate to stay the 
effectiveness of those provisions of the order to which the objections 
are made.'' Section 701(e)(3) of the act further stipulates that ``As 
soon as practicable * * *, the Secretary shall by order act upon such 
objections and make such order public.''
    The agency has completed its evaluation of the objection and the 
request for a hearing and concludes that a continuation of the stay of 
the two provisions of the regulation is not warranted.
    In the absence of any other objections and requests for a hearing, 
the agency, therefore, further concludes that this document constitutes 
final action on the objection and request for hearings received in 
response to the regulation as prescribed in section 701(e)(2) of the 
act. Therefore, the agency is acting to end the stay of the two 
provisions of the regulation by establishing a new effective date of 
November 1, 1995, for these provisions of the regulation of April 13, 
1995, listing astaxanthin for use as a color additive in the feed of 
salmonid fish to enhance the color of their flesh. As announced in the 
Federal Register of August 14, 1995 (60 FR 41805), the effective date 
of the rest of the regulation was May 16, 1995.
    -Therefore, under the Federal Food, Drug, and Cosmetic Act (secs. 
701 and 721 (21 U.S.C. 371 and 379e)) and under authority delegated to 
the Commissioner of Food and Drugs (21 CFR 5.10), notice is given that 
the objection and the request for a hearing filed in response to the 
final rule Sec. 73.35 that was published on April 13, 1995 (60 FR 
18736), do not form a basis for further stay of the effectiveness of 
the specified provisions of this final rule or require amendment of the 
regulations. Accordingly, the stay of Secs. 73.35(b) and 73.35(d)(3) 
that FDA announced on August 14, 1995 (60 FR 41805), is removed 
effective November 1, 1995. As noted previously, all other provisions 
of Sec. 73.35 became effective on May 16, 1995.

    Dated: October 25, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-27033 Filed 10-31-95; 8:45 am]
BILLING CODE 4160-01-F