[Federal Register Volume 71, Number 139 (Thursday, July 20, 2006)]
[Rules and Regulations]
[Pages 41125-41127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-11536]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. 1998C-0431] (formerly 98C-0431)


Listing of Color Additives Exempt From Certification; Mica-Based 
Pearlescent Pigments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections; removal of stay.

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SUMMARY: The Food and Drug Administration (FDA) is responding to two 
objections that it received on the final rule that amended the color 
additive regulations to provide for the safe use of mica-based 
pearlescent pigments as color additives in ingested drugs. After 
reviewing the objections, 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 
regulations. FDA is also establishing a new effective date for this 
color additive regulation, which was stayed by the filing of 
objections.

DATES: The final rule that published in the Federal Register of July 
22, 2005 (the July 2005 final rule) (70 FR 42271), with an effective 
date of August 23, 2005, was stayed by the filing of objections as 
provided for under section 701(e)(2) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 371(e)(2)) as of August 22, 2005. 
This final rule is newly effective as of July 20, 2006.

FOR FURTHER INFORMATION CONTACT: Aydin [Ouml]rstan, Center for Food 
Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1301.

SUPPLEMENTARY INFORMATION:

I. Introduction

    In the July 2005 final rule, FDA amended the color additive 
regulations to provide for the safe use of mica-based pearlescent 
pigments prepared from synthetic iron oxide, mica, and titanium dioxide 
to color ingested drugs. The preamble to the final rule advised that 
objections to the final rule and requests for a hearing were due by 
August 22, 2005, and that the rule would be effective on August 23, 
2005, except that any provisions may be stayed by the filing of proper 
objections.

II. Objections and Requests for a Hearing

    Sections 701(e)(2) and 721(d) of the act (21 U.S.C. 371(e)(2) and 
379e(d)) collectively 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 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 (21 CFR 12.24(b)(1)). (See also Community 
Nutrition Institute v. Young, 773 F.2d 1356, 1364 (D.C. Cir. 1985), 
cert. denied, 475 U.S. 1123 (1986).)
    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 
must meet the following conditions: (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) must 
specifically state the provision of the regulation or proposed order on 
which a hearing is requested (failure to request a hearing on an 
objection constitutes a waiver of the right to a hearing on that 
objection), and (5) must include a detailed description and analysis of 
the factual information to be presented in support of the objection if 
a hearing is requested (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 final rule for the use of mica-based 
pearlescent pigments to color ingested drugs, FDA received two 
submissions within the 30-day objection period. One submission objected 
to the use of pearlescent pigments in food. The submission did not 
request a hearing.
    The second submission objected to the final rule on three grounds: 
(1) The subject pearlescent pigments would have iron contaminants, (2) 
these iron contaminants would cause stability issues for active 
ingredients in drugs, and (3) the use of iron-containing pearlescent 
pigments to color drugs would limit the availability of medications for 
those who are monitoring their iron intake. This submission requested a 
hearing on these issues.

III. Standards for Granting a Hearing

    Specific criteria for determining whether to grant or deny a 
request for a hearing are set out in Sec.  12.24(b). Under that 
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 requester (a hearing will be denied if the data and information 
submitted are insufficient to justify the factual determination urged, 
even if accurate); (4) resolution of the factual issue in the

[[Page 41126]]

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); (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); and (6) the requirements in other applicable 
regulations, e.g., 21 CFR 10.20, 12.21, 12.22, 314.200, 514.200, and 
601.7(a), and in the notice issuing 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. denied, 
446 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. EPA, 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 to 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 whether 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 (see 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 raised and 
considered, a party is estopped from raising the 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 U.S. Court of Appeals for the District of 
Columbia 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 v. NLRB, 463 F.2d 316, 
322 (D.C. Cir. 1972). (See also Costle v. Pacific Legal Foundation, 
supra at 215-220; Pacific Seafarers, Inc. v. Pacific Far East Line, 
Inc., 404 F.2d 804 (D.C. Cir. 1968), cert. denied, 393 U.S. 1093 
(1969).)
    In summary, 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.
    One of the objections to the final rule on mica-based pearlescent 
pigments did not request a hearing. Therefore, FDA will rule upon the 
objection under Sec. Sec.  12.24 through 12.28 (as cited in Sec.  
12.30(b)).

IV. Analysis of Objections

    FDA addresses each of the two submissions in the following 
paragraphs, as well as the evidence and information filed in support of 
each, comparing each submission and the information submitted in 
support of it to the standards for ruling on objections and granting a 
hearing in Sec.  12.24.
    The first submission objected to the use of pearlescent pigments in 
food. This submission did not request a hearing. FDA notes that the 
final rule that is the subject of the objection provides for the safe 
use of mica-based pearlescent pigments to color ingested drugs, not 
foods. The objection to the use of pearlescent pigments in food is 
outside the scope of the July 2005 final rule. Therefore, FDA is 
denying this objection.
    The second submission asserted that the subject pearlescent 
pigments would be contaminated with iron salts and that these 
contaminants would cause stability issues for active ingredients in 
drugs that could interfere with drug efficacy. The submission also 
asserted that the iron contaminants would increase exposure to iron. 
Furthermore, the submission was concerned that the use of iron-
containing pearlescent pigments to color drugs would limit the 
availability of medications for those who are monitoring their iron 
intake. This submission requested a hearing on these issues.
    Although this submission claimed that the subject pearlescent 
pigments would be contaminated with iron salts, the submission did not 
provide any factual information to support this claim. The July 2005 
final rule was in response to a color additive petition (CAP 8C0257) 
that FDA had received from the manufacturer of the subject pearlescent 
pigments. During its review of the petition, FDA determined what 
specifications would be necessary to ensure the safe use of pearlescent 
pigments in ingested drugs and incorporated these specifications in the 
new Sec.  73.1128 (21 CFR 73.1128). FDA also reviewed the results of 
analyses of several batches of pearlescent pigments and determined that 
they complied with the specifications in the new regulation. In the 
preamble to the final rule, FDA discussed the manufacturing process of 
the subject pearlescent pigments. FDA noted that the starting materials 
for these pigments included soluble iron salts and that the 
manufacturing incorporated a heating (calcination) step at temperatures 
up to 900 [deg]C. FDA also noted that during calcination, the starting 
iron salts are converted into iron oxide.
    The submission also asserted that the iron contaminants would 
destabilize active ingredients in drugs, which would affect drug 
efficacy. As noted previously in this document, the submission did not 
provide any factual information to support the claim that the subject 
pearlescent pigments would contain iron contaminants.
    The third assertion in the submission was that the iron oxide in 
the subject pearlescent pigments is ``expected to limit availability of 
medications for the persons who must monitor iron intake.'' However, 
the submission did not provide any factual information to support this 
claim. FDA notes that, as

[[Page 41127]]

indicated in the preamble to the July 2005 final rule, the 
bioavailability of these pigments and/or their individual components 
when ingested is expected to be low.
    This submission did not provide any factual information to modify 
FDA's conclusion that the subject pearlescent pigments present no toxic 
potential when ingested at levels estimated by the agency, based on 
their proposed use in coloring ingested drugs. Namely, this submission 
did not provide specifically identified reliable evidence that can lead 
to resolution of a factual issue in dispute (Sec.  12.24(b)(2)). 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 this objection.

V. Summary and Conclusions

    The agency is denying the objections to the final rule in the two 
submissions received on the following bases. The objection to the use 
of pearlescent pigments in food is outside the scope of the July 2005 
final rule, which amended the color additive regulations to provide for 
the safe use of mica-based pearlescent pigments to color ingested 
drugs. The objections in the second submission that the subject 
pearlescent pigments would contain iron contaminants, that the iron 
contaminants would cause stability issues for active ingredients in 
drugs, and that the use of the pigments to color ingested drugs will 
limit availability of medications for the persons who must monitor 
their iron intake, are not supported by any factual information.
    The filing of the objections served to stay automatically the 
effectiveness of Sec.  73.1128. 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 objections and 
concludes that a continuation of the stay of this 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 objections 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 regulation by establishing a new 
effective date of July 20, 2006 for this regulation listing mica-based 
pearlescent pigments prepared from synthetic iron oxide, mica, and 
titanium dioxide to color ingested drugs. As announced in the July 22, 
2005, final rule, the previous effective date of the regulation was 
August 23, 2005.
    Therefore, under sections 701 and 721 of the act, notice is given 
that the objections filed in response to the July 2005 final rule do 
not form the basis for further stay of this final rule or require 
amendment of the regulations. Accordingly, the stay of Sec.  73.1128 
that FDA is announcing in this document is removed effective July 20, 
2006.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and under 
authority delegated to the Commissioner of Food and Drugs (section 
1410.10 of the FDA Staff Manual Guide), notice is given that objections 
and a request for a hearing were filed in response to the July 22, 
2005, final rule. Notice is also given that the agency is denying these 
objections. Accordingly, the amendments issued thereby are effective 
July 20, 2006.

    Dated: July 14, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-11536 Filed 7-19-06; 8:45 am]
BILLING CODE 4160-01-S