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Federal Register Final Rule - 71 FR 41125 July 20, 2006: Listing of Color Additives Exempt From Certification; Mica-Based Pearlescent Pigments; response to objections; removal of stay

 
[Federal Register: July 20, 2006 (Volume 71, Number 139)]
[Rules and Regulations]
[Page 41125-41127]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20jy06-10]
 
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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 Örstan, 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