[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Rules and Regulations]
[Pages 9448-9449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1710]


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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]
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