Listing of Color Additives Exempt From Certification; Tomato Lycopene Extract and Tomato Lycopene Concentrate, 9448-9449 [06-1710]
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Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Rules and Regulations
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VerDate Aug<31>2005
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By the Commission.
Magalie R. Salas,
Secretary.
[FR Doc. 06–1654 Filed 2–23–06; 8:45 am]
BILLING CODE 6717–01–P
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.
Final rule; response to
objections; removal of stay.
ACTION:
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
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
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 § 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
E:\FR\FM\24FER1.SGM
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Federal Register / Vol. 71, No. 37 / Friday, February 24, 2006 / Rules and Regulations
wwhite on PROD1PC61 with RULES
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 (§ 12.24(b)(3)).
The second objection requested that
FDA broaden the scope of the regulation
to include the use of lycopene isolated
VerDate Aug<31>2005
18:05 Feb 23, 2006
Jkt 208001
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 (§ 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 § 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
§ 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,
PO 00000
Frm 00023
Fmt 4700
Sfmt 4700
9449
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 § 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
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 301
[TD 9252]
RIN 1545–BF22
Procedures for Administrative Review
of a Determination That an Authorized
Recipient Has Failed to Safeguard Tax
Returns or Return Information
Internal Revenue Service (IRS),
Treasury.
ACTIONS: Temporary regulations.
AGENCY:
SUMMARY: This document contains
temporary regulations regarding
administrative review procedures for
certain government agencies and other
authorized recipients of tax returns or
return information (authorized
recipients) whose receipt of returns and
return information may be suspended or
terminated because they do not
maintain proper safeguards. The
temporary regulations provide guidance
to responsible IRS personnel and
authorized recipients as to these
administrative procedures. The text of
these temporary regulations serves as
the text of the proposed regulations set
forth in the notice of proposed
rulemaking on this subject in the
Proposed Rules section of this issue of
the Federal Register.
DATES: Effective Date: These regulations
are effective February 24, 2006.
Applicability Date: For dates of
applicability, see § 301.6103(p)(7)–
1T(e).
FOR FURTHER INFORMATION CONTACT:
Melinda Fisher, (202) 622–4580 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
Background
Under section 6103 of the Internal
Revenue Code (Code), tax returns and
return information are protected from
disclosure except in specifically
enumerated circumstances. Where
disclosure is permitted, section 6103
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24FER1
]]>Agencies
[Federal Register Volume 71, Number 37 (Friday, February 24, 2006)]
[Rules and Regulations]
[Pages 9448-9449]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-1710]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
