Certification Requirements for Imported Natural Wine (2005R-002P), 22816-22818 [E8-9173]
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Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Rules and Regulations
analysis, and reporting of clinical trials
in a way that provides assurance that
the data and reported results are
credible and accurate and that the
rights, safety, and well-being of trial
subjects are protected. GCP includes
review and approval (or provision of a
favorable opinion) by an independent
ethics committee (IEC) before initiating
a study, continuing review of an
ongoing study by an IEC, and obtaining
and documenting the freely given
informed consent of the subject (or a
subject’s legally authorized
representative, if the subject is unable to
provide informed consent) before
initiating a study. GCP does not require
informed consent in life-threatening
situations when the IEC reviewing the
study finds, before initiation of the
study, that informed consent is not
feasible and either that the conditions
present are consistent with those
described in § 50.23 or § 50.24(a) of this
chapter, or that the measures described
in the study protocol or elsewhere will
protect the rights, safety, and well-being
of subjects; and
(ii) FDA is able to validate the data
from the study through an onsite
inspection if the agency deems it
necessary.
(2) Although FDA will not accept as
support for an IND or application for
marketing approval a study that does
not meet the conditions of paragraph
(a)(1) of this section, FDA will examine
data from such a study.
(3) Marketing approval of a new drug
based solely on foreign clinical data is
governed by § 314.106 of this chapter.
(b) Supporting information. A sponsor
or applicant who submits data from a
foreign clinical study not conducted
under an IND as support for an IND or
application for marketing approval must
submit to FDA, in addition to
information required elsewhere in parts
312, 314, or 601 of this chapter, a
description of the actions the sponsor or
applicant took to ensure that the
research conformed to GCP as described
in paragraph (a)(1)(i) of this section. The
description is not required to duplicate
information already submitted in the
IND or application for marketing
approval. Instead, the description must
provide either the following information
or a cross-reference to another section of
the submission where the information is
located:
(1) The investigator’s qualifications;
(2) A description of the research
facilities;
(3) A detailed summary of the
protocol and results of the study and,
should FDA request, case records
maintained by the investigator or
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16:07 Apr 25, 2008
Jkt 214001
additional background data such as
hospital or other institutional records;
(4) A description of the drug
substance and drug product used in the
study, including a description of the
components, formulation,
specifications, and, if available,
bioavailability of the specific drug
product used in the clinical study;
(5) If the study is intended to support
the effectiveness of a drug product,
information showing that the study is
adequate and well controlled under
§ 314.126 of this chapter;
(6) The name and address of the IEC
that reviewed the study and a statement
that the IEC meets the definition in
§ 312.3 of this chapter. The sponsor or
applicant must maintain records
supporting such statement, including
records of the names and qualifications
of IEC members, and make these records
available for agency review upon
request;
(7) A summary of the IEC’s decision
to approve or modify and approve the
study, or to provide a favorable opinion;
(8) A description of how informed
consent was obtained;
(9) A description of what incentives,
if any, were provided to subjects to
participate in the study;
(10) A description of how the
sponsor(s) monitored the study and
ensured that the study was carried out
consistently with the study protocol;
and
(11) A description of how
investigators were trained to comply
with GCP (as described in paragraph
(a)(1)(i) of this section) and to conduct
the study in accordance with the study
protocol, and a statement on whether
written commitments by investigators to
comply with GCP and the protocol were
obtained. Any signed written
commitments by investigators must be
maintained by the sponsor or applicant
and made available for agency review
upon request.
(c) Waivers. (1) A sponsor or applicant
may ask FDA to waive any applicable
requirements under paragraphs (a)(1)
and (b) of this section. A waiver request
may be submitted in an IND or in an
information amendment to an IND, or in
an application or in an amendment or
supplement to an application submitted
under part 314 or 601 of this chapter. A
waiver request is required to contain at
least one of the following:
(i) An explanation why the sponsor’s
or applicant’s compliance with the
requirement is unnecessary or cannot be
achieved;
(ii) A description of an alternative
submission or course of action that
satisfies the purpose of the requirement;
or
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(iii) Other information justifying a
waiver.
(2) FDA may grant a waiver if it finds
that doing so would be in the interest of
the public health.
(d) Records. A sponsor or applicant
must retain the records required by this
section for a foreign clinical study not
conducted under an IND as follows:
(1) If the study is submitted in
support of an application for marketing
approval, for 2 years after an agency
decision on that application;
(2) If the study is submitted in
support of an IND but not an application
for marketing approval, for 2 years after
the submission of the IND.
Dated: April 21, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–9200 Filed 4–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade
Bureau
27 CFR Parts 4, 24, and 27
[Docket No. TTB–2007–0006; T.D. TTB–70;
Re: T.D. TTB–31 and Notice No. 51]
RIN 1513–AB00
Certification Requirements for
Imported Natural Wine (2005R–002P)
Alcohol and Tobacco Tax and
Trade Bureau (TTB), Treasury.
ACTION: Final rule; Treasury decision.
AGENCY:
SUMMARY: The Alcohol and Tobacco Tax
and Trade Bureau is adopting as a final
rule, without changes, the temporary
regulations implementing the
certification requirements regarding
production practices and procedures for
imported natural wine. These
requirements were adopted in section
2002 of the Miscellaneous Trade and
Technical Corrections Act of 2004 as an
amendment to section 5382 of the
Internal Revenue Code of 1986.
DATES: Effective Date: This final rule is
effective on May 28, 2008.
FOR FURTHER INFORMATION CONTACT:
Jennifer Berry, Alcohol and Tobacco
Tax and Trade Bureau, Regulations and
Rulings Division, P.O. Box 18152,
Roanoke, VA 24014; telephone 540–
344–9333.
SUPPLEMENTARY INFORMATION:
Background
The Alcohol and Tobacco Tax and
Trade Bureau (TTB) is responsible for
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hsrobinson on PROD1PC76 with RULES
Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Rules and Regulations
the administration of Chapter 51 of the
Internal Revenue Code of 1986 (IRC)
which includes provisions relating to
the taxation of wine. Section 5382(a) of
the IRC (26 U.S.C. 5382(a)) sets forth
standards regarding what constitutes
proper cellar treatment of natural wine.
On December 3, 2004, the President
signed into law the Miscellaneous Trade
and Technical Corrections Act of 2004,
Public Law 108–429, 118 Stat. 2434
(‘‘the Act’’), which revised section
5382(a) of the IRC to accommodate two
new provisions. The first new provision
was paragraph (1)(B), which provides
that, in the case of wine produced and
imported subject to an international
agreement or treaty, proper cellar
treatment of natural wine includes those
practices and procedures acceptable to
the United States under the agreement
or treaty. The second new provision was
paragraph (3), which sets forth a new
certification requirement regarding
production practices and procedures for
imported natural wine produced after
December 31, 2004.
Under section 5382(a)(3) the Secretary
of the Treasury shall accept the
practices and procedures used to
produce wine in another country if, at
the time of importation of the wine, one
of the following conditions is met:
• The Secretary has on file or is
provided with a certification from the
government of the producing country,
accompanied by an affirmed laboratory
analysis, that the practices and
procedures used to produce the wine
constitute proper cellar treatment under
regulations prescribed by the Secretary;
• The Secretary has on file or is
provided with a certification required
by an international agreement or treaty
covering proper cellar treatment, or the
wine is covered by an international
agreement or treaty covering proper
cellar treatment that does not require a
certification; or
• In the case of an importer that owns
or controls or that has an affiliate that
owns or controls a winery operating
under a basic permit issued by the
Secretary, the importer certifies that the
practices and procedures used to
produce the wine constitute proper
cellar treatment under regulations
prescribed by the Secretary.
In addition, for purposes of the
certification requirement, section
5382(a)(3) defines ‘‘affiliate’’ as having
the meaning contained in section
117(a)(4) of the Federal Alcohol
Administration Act (27 U.S.C.
211(a)(4)), and as including ‘‘a winery’s
parent or subsidiary or any other entity
in which the winery’s parent or
subsidiary has an ownership interest.’’
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16:07 Apr 25, 2008
Jkt 214001
Temporary Rule and Notice of
Proposed Rulemaking
On August 24, 2005, TTB published
in the Federal Register (70 FR 49479) a
temporary rule, T.D. TTB–31, which
implemented the above described
certification requirements by amending
27 CFR parts 4, 24, and 27. In
conjunction with the publication of T.D.
TTB–31, TTB published a notice of
proposed rulemaking, Notice No. 51, in
the Federal Register (70 FR 49516) on
August 24, 2005, referencing and
inviting comments on T.D. TTB–31. The
comment period closed October 24,
2005.
Comments and TTB Analysis
TTB received four comments during
the comment period. Below, we
summarize and respond to the four
comments.
Comment
The Embassy of Switzerland
commented that requiring certification
for shipments of limited quantities
could create impediments to the
introduction of new products. It
therefore urged TTB to exempt from
certification shipments of limited
quantities and non-commercial
shipments intended for trade fairs or
exhibits.
TTB Response
The implementing regulations include
an exemption for importations of
commercial samples of natural wine.
Under 27 CFR 27.140(b)(2)(ii)(C),
commercial samples include sales
samples, samples for trade shows, and
samples imported for laboratory
analysis. We believe this provision
addresses the commenter’s concern
regarding shipments for trade shows
and exhibits. We also believe that 27
CFR 27.140(b)(2)(ii)(B), which exempts
importations of a personal, noncommercial nature, could apply to many
of the shipments of limited quantities
mentioned by the commenter.
Comment
The National Association of Beverage
Importers, Inc. (NABI), in its comment,
stated that TTB did not define the word
‘‘importer’’ in the temporary
regulations, making it unclear who must
retain a copy of the certification. It
stated that in the industry, ‘‘importer’’
could mean either the ‘‘authorized
importer’’ or the ‘‘importer of record.’’
According to NABI, the ‘‘authorized
importer’’ is authorized by the foreign
supplier to import the supplier’s wine
into the U.S., whereas the ‘‘importer of
record’’ is the importer that physically
imports the wine (sic), usually using a
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22817
certificate of label approval (COLA)
owned by the authorized importer.
NABI therefore asked which type of
importer must maintain a copy of the
certification in their records. NABI
believes that the COLA owner should be
required to retain the certification. NABI
also requested clarification regarding
wine that is a blend of wines from
multiple suppliers, asking if the
importer must obtain certifications for
all the wines used in a blend or only for
the finished wine.
TTB Response
‘‘Importer’’ is defined in § 27.140 of
the implementing regulations as ‘‘any
person importing wine who must obtain
a permit as provided in § 27.55.’’ Under
§ 27.55, any person who intends to
engage in the business of importing
wines must obtain a permit from TTB.
If a COLA holder is also the actual
importer, that COLA holder would have
to both obtain a permit and retain the
certification, a copy of which is
sufficient for this purpose. TTB believes
the regulations are sufficiently clear on
this point.
With regard to NABI’s second point,
we note that the certification
requirement applies to the wine that is
imported into the United States, that is,
the certification is required only for the
finished wine if that is the wine that is
imported. If the component wines were
imported into the United States for
blending here, then the certification
requirement would apply to each of the
component wines that is imported. If
the wine is blended before importation,
a certificate is required only for the
finished, blended wine. We believe the
regulatory language is also sufficiently
clear on this point.
Comment
The Wine Institute filed a comment
disagreeing with the position taken by
TTB in the temporary rule regarding
self-certification, that is, that the statute
does not allow self-certification by a
winery when the winery owns or
controls an importer rather than the
other way around. The Wine Institute
stated that a winery operating under a
basic permit is the more qualified of the
two entities to make this certification.
The Wine Institute contends that TTB
has the authority to infer that Congress
did not intend to make this exclusion
and that TTB should therefore revise the
temporary regulations to allow a winery
owning or controlling an importer to
self-certify its imports.
TTB Response
TTB notes that the statutory language
contained in 26 U.S.C. 5382(a)(3)(A)(iii)
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Federal Register / Vol. 73, No. 82 / Monday, April 28, 2008 / Rules and Regulations
very specifically refers only to an
importer that owns or controls a winery
or that has an affiliate that owns or
controls a winery operating under a
basic permit. The statutory language
does not suggest that Congress intended
the statute also to allow self-certification
by a winery that owns or controls an
importer or that has an affiliate to that
owns or controls an importer.
Accordingly, we do not believe
Congress intended the interpretation
suggested in this comment.
Regarding the request for a delay in
the implementation date, TTB does not
have the authority to change the
implementation date of the certification
requirements, which is prescribed by
the statute.
Drafting Information
TTB Finding
List of Subjects
Based on the reasons set forth above
and on the comments received, we
believe it is appropriate to adopt the
temporary rule as a final rule without
change.
27 CFR Part 4
Comment
Regulatory Flexibility Act
The Government of Canada submitted
a comment requesting that certain types
of Canadian wines—non-grape wines,
cider, and wines containing less than 7
percent alcohol by volume—be exempt
from the certification requirements.
These wines are outside the scope of the
‘‘Agreement on Mutual Acceptance of
Oenological Practices’’ (MAA) signed by
several nations including Canada and
the United States, which covers only
natural grape wines that are at least 7
percent alcohol by volume, and are
therefore subject to the certification
requirements. Canada contends that an
exemption would be justified because
Canadian regulations require that fruit
wines (other than cider) and wines
containing less than 7 percent alcohol
by volume must be produced in
accordance with the same standards as
wines covered by the MAA.
Canada also requested consideration
of an exemption from the certification
requirements for the importation of
small quantities of non-grape natural
wine from Canada in order to mitigate
the potential economic impact on small
exporters. Canada stated that because
these wines are exported in limited
quantities by small exporters the cost of
complying with the requirements will
be prohibitive and may shut these
products out of the U.S. market. Finally,
Canada requested that we delay the
implementation of the certification
requirements until the United States
and Canada can reach an agreement on
an import certification regime covering
these wines.
We certify that this regulation will not
have a significant impact on a
substantial number of small entities.
This regulation adopts without change a
temporary rule that incorporated some
reporting and recordkeeping
requirements. It was previously
concluded that those requirements were
expected to be of minimal burden, and
we have received no information that
contradicts that previous determination.
Therefore, no regulatory flexibility
analysis is required. Additionally,
pursuant to section 7805(f) of the
Internal Revenue Code, we submitted
the temporary rule to the Chief Counsel
for Advocacy of the Small Business
Administration for comment on the
impact to small businesses. That office
did not comment on the temporary rule.
27 CFR Part 24
Paperwork Reduction Act
For the reasons stated in the
preamble, the temporary rule published
in the Federal Register at 70 FR 49479
on August 24, 2005, is adopted as a final
rule without change.
hsrobinson on PROD1PC76 with RULES
TTB Response
We are unable to provide the two
requested exemptions. The non-grape
wines and other products described by
Canada clearly fall within the
certification requirements of the statute.
The fact that they are produced in
accordance with the same standards as
wine covered by the scope of the MAA
or are only exported in limited
quantities cannot override the clear
wording of the statute.
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16:07 Apr 25, 2008
Jkt 214001
The collections of information
contained in this final regulation have
been previously reviewed and approved
by the Office of Management and
Budget (OMB) in accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)) and assigned OMB
control number 1513–0119. An agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a valid control number
assigned by OMB. This final rule
restates the collection of information
without substantive change.
Comments concerning suggestions for
reducing the burden of the collections of
information should be directed to Mary
A. Wood, Alcohol and Tobacco Tax and
Trade Bureau, at any of these addresses:
• P.O. Box 14412, Washington, DC
20044–4412;
• 202–927–8525 (facsimile); or
• formcomments@ttb.gov (e-mail).
The principal author of this document
was Jennifer K. Berry, Regulations and
Rulings Division, Alcohol and Tobacco
Tax and Trade Bureau. Other personnel
also participated in its development.
Advertising, Customs duties and
inspection, Imports, Labeling, Packaging
and containers, Reporting and
recordkeeping requirements, Trade
practices, Wine.
Administrative practice and
procedure, Claims, Electronic fund
transfers, Excise taxes, Exports, Food
additives, Fruit juices, Labeling,
Liquors, Packaging and containers,
Reporting and recordkeeping
requirements, Research, Scientific
equipment, Spices and flavoring, Surety
bonds, Vinegar, Warehouses, Wine.
27 CFR Part 27
Alcohol and alcoholic beverages,
Beer, Customs duties and inspection,
Electronic funds transfers, Excise taxes,
Imports, Labeling, Liquors, Packaging
and containers, Reporting and
recordkeeping requirements, Wine.
The Regulatory Amendment
Signed: January 2, 2008.
John J. Manfreda,
Administrator.
Approved: March 24, 2008.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and
Tariff Policy).
[FR Doc. E8–9173 Filed 4–25–08; 8:45 am]
BILLING CODE 4810–31–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–HQ–OAR–2007–0510; FRL–8556–1]
Withdrawal of Federal Implementation
Plans for the Clean Air Interstate Rule
in 12 States
Environmental Protection
Agency (EPA).
ACTION: Final rule.
Executive Order 12866
AGENCY:
This rule is not a significant
regulatory action as defined in
Executive Order 12866. Therefore, it
requires no regulatory assessment.
SUMMARY: EPA is withdrawing Federal
Implementation Plans (FIPs) for the
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]]>Agencies
[Federal Register Volume 73, Number 82 (Monday, April 28, 2008)]
[Rules and Regulations]
[Pages 22816-22818]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-9173]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF THE TREASURY
Alcohol and Tobacco Tax and Trade Bureau
27 CFR Parts 4, 24, and 27
[Docket No. TTB-2007-0006; T.D. TTB-70; Re: T.D. TTB-31 and Notice No.
51]
RIN 1513-AB00
Certification Requirements for Imported Natural Wine (2005R-002P)
AGENCY: Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.
ACTION: Final rule; Treasury decision.
-----------------------------------------------------------------------
SUMMARY: The Alcohol and Tobacco Tax and Trade Bureau is adopting as a
final rule, without changes, the temporary regulations implementing the
certification requirements regarding production practices and
procedures for imported natural wine. These requirements were adopted
in section 2002 of the Miscellaneous Trade and Technical Corrections
Act of 2004 as an amendment to section 5382 of the Internal Revenue
Code of 1986.
DATES: Effective Date: This final rule is effective on May 28, 2008.
FOR FURTHER INFORMATION CONTACT: Jennifer Berry, Alcohol and Tobacco
Tax and Trade Bureau, Regulations and Rulings Division, P.O. Box 18152,
Roanoke, VA 24014; telephone 540-344-9333.
SUPPLEMENTARY INFORMATION:
Background
The Alcohol and Tobacco Tax and Trade Bureau (TTB) is responsible
for
[[Page 22817]]
the administration of Chapter 51 of the Internal Revenue Code of 1986
(IRC) which includes provisions relating to the taxation of wine.
Section 5382(a) of the IRC (26 U.S.C. 5382(a)) sets forth standards
regarding what constitutes proper cellar treatment of natural wine.
On December 3, 2004, the President signed into law the
Miscellaneous Trade and Technical Corrections Act of 2004, Public Law
108-429, 118 Stat. 2434 (``the Act''), which revised section 5382(a) of
the IRC to accommodate two new provisions. The first new provision was
paragraph (1)(B), which provides that, in the case of wine produced and
imported subject to an international agreement or treaty, proper cellar
treatment of natural wine includes those practices and procedures
acceptable to the United States under the agreement or treaty. The
second new provision was paragraph (3), which sets forth a new
certification requirement regarding production practices and procedures
for imported natural wine produced after December 31, 2004.
Under section 5382(a)(3) the Secretary of the Treasury shall accept
the practices and procedures used to produce wine in another country
if, at the time of importation of the wine, one of the following
conditions is met:
The Secretary has on file or is provided with a
certification from the government of the producing country, accompanied
by an affirmed laboratory analysis, that the practices and procedures
used to produce the wine constitute proper cellar treatment under
regulations prescribed by the Secretary;
The Secretary has on file or is provided with a
certification required by an international agreement or treaty covering
proper cellar treatment, or the wine is covered by an international
agreement or treaty covering proper cellar treatment that does not
require a certification; or
In the case of an importer that owns or controls or that
has an affiliate that owns or controls a winery operating under a basic
permit issued by the Secretary, the importer certifies that the
practices and procedures used to produce the wine constitute proper
cellar treatment under regulations prescribed by the Secretary.
In addition, for purposes of the certification requirement, section
5382(a)(3) defines ``affiliate'' as having the meaning contained in
section 117(a)(4) of the Federal Alcohol Administration Act (27 U.S.C.
211(a)(4)), and as including ``a winery's parent or subsidiary or any
other entity in which the winery's parent or subsidiary has an
ownership interest.''
Temporary Rule and Notice of Proposed Rulemaking
On August 24, 2005, TTB published in the Federal Register (70 FR
49479) a temporary rule, T.D. TTB-31, which implemented the above
described certification requirements by amending 27 CFR parts 4, 24,
and 27. In conjunction with the publication of T.D. TTB-31, TTB
published a notice of proposed rulemaking, Notice No. 51, in the
Federal Register (70 FR 49516) on August 24, 2005, referencing and
inviting comments on T.D. TTB-31. The comment period closed October 24,
2005.
Comments and TTB Analysis
TTB received four comments during the comment period. Below, we
summarize and respond to the four comments.
Comment
The Embassy of Switzerland commented that requiring certification
for shipments of limited quantities could create impediments to the
introduction of new products. It therefore urged TTB to exempt from
certification shipments of limited quantities and non-commercial
shipments intended for trade fairs or exhibits.
TTB Response
The implementing regulations include an exemption for importations
of commercial samples of natural wine. Under 27 CFR
27.140(b)(2)(ii)(C), commercial samples include sales samples, samples
for trade shows, and samples imported for laboratory analysis. We
believe this provision addresses the commenter's concern regarding
shipments for trade shows and exhibits. We also believe that 27 CFR
27.140(b)(2)(ii)(B), which exempts importations of a personal, non-
commercial nature, could apply to many of the shipments of limited
quantities mentioned by the commenter.
Comment
The National Association of Beverage Importers, Inc. (NABI), in its
comment, stated that TTB did not define the word ``importer'' in the
temporary regulations, making it unclear who must retain a copy of the
certification. It stated that in the industry, ``importer'' could mean
either the ``authorized importer'' or the ``importer of record.''
According to NABI, the ``authorized importer'' is authorized by the
foreign supplier to import the supplier's wine into the U.S., whereas
the ``importer of record'' is the importer that physically imports the
wine (sic), usually using a certificate of label approval (COLA) owned
by the authorized importer. NABI therefore asked which type of importer
must maintain a copy of the certification in their records. NABI
believes that the COLA owner should be required to retain the
certification. NABI also requested clarification regarding wine that is
a blend of wines from multiple suppliers, asking if the importer must
obtain certifications for all the wines used in a blend or only for the
finished wine.
TTB Response
``Importer'' is defined in Sec. 27.140 of the implementing
regulations as ``any person importing wine who must obtain a permit as
provided in Sec. 27.55.'' Under Sec. 27.55, any person who intends to
engage in the business of importing wines must obtain a permit from
TTB. If a COLA holder is also the actual importer, that COLA holder
would have to both obtain a permit and retain the certification, a copy
of which is sufficient for this purpose. TTB believes the regulations
are sufficiently clear on this point.
With regard to NABI's second point, we note that the certification
requirement applies to the wine that is imported into the United
States, that is, the certification is required only for the finished
wine if that is the wine that is imported. If the component wines were
imported into the United States for blending here, then the
certification requirement would apply to each of the component wines
that is imported. If the wine is blended before importation, a
certificate is required only for the finished, blended wine. We believe
the regulatory language is also sufficiently clear on this point.
Comment
The Wine Institute filed a comment disagreeing with the position
taken by TTB in the temporary rule regarding self-certification, that
is, that the statute does not allow self-certification by a winery when
the winery owns or controls an importer rather than the other way
around. The Wine Institute stated that a winery operating under a basic
permit is the more qualified of the two entities to make this
certification. The Wine Institute contends that TTB has the authority
to infer that Congress did not intend to make this exclusion and that
TTB should therefore revise the temporary regulations to allow a winery
owning or controlling an importer to self-certify its imports.
TTB Response
TTB notes that the statutory language contained in 26 U.S.C.
5382(a)(3)(A)(iii)
[[Page 22818]]
very specifically refers only to an importer that owns or controls a
winery or that has an affiliate that owns or controls a winery
operating under a basic permit. The statutory language does not suggest
that Congress intended the statute also to allow self-certification by
a winery that owns or controls an importer or that has an affiliate to
that owns or controls an importer. Accordingly, we do not believe
Congress intended the interpretation suggested in this comment.
Comment
The Government of Canada submitted a comment requesting that
certain types of Canadian wines--non-grape wines, cider, and wines
containing less than 7 percent alcohol by volume--be exempt from the
certification requirements. These wines are outside the scope of the
``Agreement on Mutual Acceptance of Oenological Practices'' (MAA)
signed by several nations including Canada and the United States, which
covers only natural grape wines that are at least 7 percent alcohol by
volume, and are therefore subject to the certification requirements.
Canada contends that an exemption would be justified because Canadian
regulations require that fruit wines (other than cider) and wines
containing less than 7 percent alcohol by volume must be produced in
accordance with the same standards as wines covered by the MAA.
Canada also requested consideration of an exemption from the
certification requirements for the importation of small quantities of
non-grape natural wine from Canada in order to mitigate the potential
economic impact on small exporters. Canada stated that because these
wines are exported in limited quantities by small exporters the cost of
complying with the requirements will be prohibitive and may shut these
products out of the U.S. market. Finally, Canada requested that we
delay the implementation of the certification requirements until the
United States and Canada can reach an agreement on an import
certification regime covering these wines.
TTB Response
We are unable to provide the two requested exemptions. The non-
grape wines and other products described by Canada clearly fall within
the certification requirements of the statute. The fact that they are
produced in accordance with the same standards as wine covered by the
scope of the MAA or are only exported in limited quantities cannot
override the clear wording of the statute.
Regarding the request for a delay in the implementation date, TTB
does not have the authority to change the implementation date of the
certification requirements, which is prescribed by the statute.
TTB Finding
Based on the reasons set forth above and on the comments received,
we believe it is appropriate to adopt the temporary rule as a final
rule without change.
Regulatory Flexibility Act
We certify that this regulation will not have a significant impact
on a substantial number of small entities. This regulation adopts
without change a temporary rule that incorporated some reporting and
recordkeeping requirements. It was previously concluded that those
requirements were expected to be of minimal burden, and we have
received no information that contradicts that previous determination.
Therefore, no regulatory flexibility analysis is required.
Additionally, pursuant to section 7805(f) of the Internal Revenue Code,
we submitted the temporary rule to the Chief Counsel for Advocacy of
the Small Business Administration for comment on the impact to small
businesses. That office did not comment on the temporary rule.
Paperwork Reduction Act
The collections of information contained in this final regulation
have been previously reviewed and approved by the Office of Management
and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995
(44 U.S.C. 3507(d)) and assigned OMB control number 1513-0119. An
agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a valid
control number assigned by OMB. This final rule restates the collection
of information without substantive change.
Comments concerning suggestions for reducing the burden of the
collections of information should be directed to Mary A. Wood, Alcohol
and Tobacco Tax and Trade Bureau, at any of these addresses:
P.O. Box 14412, Washington, DC 20044-4412;
202-927-8525 (facsimile); or
formcomments@ttb.gov (e-mail).
Executive Order 12866
This rule is not a significant regulatory action as defined in
Executive Order 12866. Therefore, it requires no regulatory assessment.
Drafting Information
The principal author of this document was Jennifer K. Berry,
Regulations and Rulings Division, Alcohol and Tobacco Tax and Trade
Bureau. Other personnel also participated in its development.
List of Subjects
27 CFR Part 4
Advertising, Customs duties and inspection, Imports, Labeling,
Packaging and containers, Reporting and recordkeeping requirements,
Trade practices, Wine.
27 CFR Part 24
Administrative practice and procedure, Claims, Electronic fund
transfers, Excise taxes, Exports, Food additives, Fruit juices,
Labeling, Liquors, Packaging and containers, Reporting and
recordkeeping requirements, Research, Scientific equipment, Spices and
flavoring, Surety bonds, Vinegar, Warehouses, Wine.
27 CFR Part 27
Alcohol and alcoholic beverages, Beer, Customs duties and
inspection, Electronic funds transfers, Excise taxes, Imports,
Labeling, Liquors, Packaging and containers, Reporting and
recordkeeping requirements, Wine.
The Regulatory Amendment
For the reasons stated in the preamble, the temporary rule
published in the Federal Register at 70 FR 49479 on August 24, 2005, is
adopted as a final rule without change.
Signed: January 2, 2008.
John J. Manfreda,
Administrator.
Approved: March 24, 2008.
Timothy E. Skud,
Deputy Assistant Secretary (Tax, Trade, and Tariff Policy).
[FR Doc. E8-9173 Filed 4-25-08; 8:45 am]
BILLING CODE 4810-31-P
