[Federal Register: February 24, 2006 (Volume 71, Number 37)]
[Rules and Regulations]
[Page 9448-9449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe06-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. 2001C-0486] (formerly Docket No. 01C-0486)
Listing of Color Additives Exempt From Certification; Tomato
Lycopene Extract and Tomato Lycopene Concentrate
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 authorizing the use of tomato lycopene extract and
tomato lycopene concentrate as color additives in foods. After
reviewing the objections to the final rule, the agency has concluded
that the objections do not raise issues of material fact that justify a
hearing or otherwise provide a basis for modifying the amendment to the
regulation. FDA is also establishing a new effective date for this
color additive regulation, which was stayed by the filing of proper
objections.
DATES: The final rule that published in the Federal Register of July
26, 2005 (70 FR 43043), with an effective date of August 26, 2005, was
stayed by the filing of objections as provided for under section
701(e)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(e)(2)) as of August 25, 2005. This final rule is newly effective as
of February 24, 2006.
FOR FURTHER INFORMATION CONTACT: James C. Wallwork, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1303.
SUPPLEMENTARY INFORMATION:
I. Introduction
FDA published a notice in the Federal Register on October 30, 2001
(66 FR 54773), announcing the filing of a color additive petition (CAP
1C0273) by LycoRed Natural Products Industries to amend the color
additive regulations in part 73 (21 CFR part 73) to provide for the
safe use of tomato lycopene extract to color foods generally. The
petition included information on two forms of tomato lycopene (extract
and concentrate) that differ primarily in concentration. In the Federal
Register of July 26, 2005 (70 FR 43043), the agency issued a final rule
providing for the safe use of tomato lycopene extract and tomato
lycopene concentrate as color additives in foods. The preamble to the
final rule advised that objections to the final rule and requests for a
hearing were due within 30 days of the publication date (i.e., by
August 25, 2005) and that the rule would be effective on August 26,
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 Federal Food, Drug, and
Cosmetic Act (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 reasonable grounds
therefore, and requesting a public hearing based upon such
objections.''
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
[[Page 9449]]
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, FDA received two
objections within the 30-day objection period. Neither objection
requested a hearing; therefore a hearing has been waived (21 CFR
12.22(a)(4)). One objection asserted that lycopene extracted from
tomatoes ``could trigger more individuals to become allergic to
tomatoes and could even become life threatening through anaphylactic
shock to those of us who have severe allergies.'' As an alternative to
revoking the regulation, the submission proposed that lycopene
extracted from tomatoes ``must be labeled as such.'' The second
objection requested that the scope of the regulation be broadened to
include the use of lycopene isolated from other plant sources, such as
watermelon, as a color additive in foods.
III. Analysis of Objections
FDA addresses each of the two objections in the following
paragraphs, as well as the evidence and information filed in support of
each.
One submission objected to the final rule, asserting that people
who have a severe tomato allergy may experience an allergic reaction to
lycopene extracted from tomatoes and that exposure to lycopene
extracted from tomatoes may cause sensitive individuals to develop an
allergy to tomatoes. The objector did not provide reliable data and
information to support the assertion that sensitive individuals will
exhibit an allergic reaction to lycopene extracted from tomatoes. The
objector also did not provide evidence that sensitive individuals may
develop an allergy to tomatoes from exposure to lycopene extracted from
tomatoes. Therefore, the submission provided no information that would
support a reevaluation of the agency's safety analysis of lycopene
extracted from tomatoes. FDA concludes that this submission provides no
basis for the agency to reconsider its decision to issue the final rule
on the use of lycopene extract and concentrate as a color additive in
food. Therefore, FDA is denying this objection (Sec. 12.24(b)(3)).
The second objection requested that FDA broaden the scope of the
regulation to include the use of lycopene isolated from other plant
sources, such as watermelon, as an additive in foods. FDA is denying
this objection because the request is inconsistent with the act and
FDA's regulations (Sec. 12.24(b)(5)). If the submitter desires to
expand the uses covered by the lycopene regulation, the proper course
is to file a separate petition to amend the lycopene color additive
regulation, meeting all requirements for such a petition (e.g., 21 CFR
part 71).
IV. Summary and Conclusions
The agency is denying the objections on the following grounds: (1)
The submission based on an allergy to tomato-derived lycopene does not
include evidence that calls into question FDA's conclusion that the use
of lycopene extracted from tomatoes is safe for use as a color additive
in foods and (2) the request to include under Sec. 73.585 lycopene
extracted from other plant sources, such as watermelon, is beyond the
scope of the petitioned action for tomato-derived lycopene and is
appropriately resolved through the submission of a separate petition.
The filing of the objections served to stay automatically the
effectiveness of Sec. 73.585. Section 701(e)(2) of the act states that
``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 provides 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 February 24, 2006 for this regulation, listing tomato
lycopene extract and tomato lycopene concentrate as color additives in
foods. As announced in the Federal Register of July 26, 2005 (70 FR
43043), the previous effective date of the regulation was August 26,
2005.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, notice is
given that the objections filed in response to the final rule that was
published on July 26, 2005 (70 FR 43043), do not form the basis for
further stay of this final rule or require amendment of the
regulations. Accordingly, the stay of Sec. 73.585 that FDA is
announcing in this document, is removed effective February 24, 2006.
Dated: February 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-1710 Filed 2-23-06; 8:45 am]
BILLING CODE 4160-01-S