Federal Register, Volume 77 Issue 142 (Tuesday, July 24, 2012)

[Federal Register Volume 77, Number 142 (Tuesday, July 24, 2012)]
[Notices]
[Pages 43335-43337]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18028]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0268]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling of Certain
Beers Subject to the Labeling Jurisdiction of the Food and Drug
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by August
23, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-New and
title ``Labeling of Certain Beers Subject to the Labeling Jurisdiction
of the Food and Drug Administration.'' Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T,
Rockville, MD 20850, domini.bean@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration--(OMB Control Number 0910-New)

I. Background

In the Federal Register of August 17, 2009 (74 FR 41438) (the
August 17, 2009, notice), FDA published a notice of availability of the
draft guidance document entitled ``Labeling of Certain Beers Subject to
the Labeling Jurisdiction of the Food and Drug Administration'' (the
draft guidance). Persons with access to the Internet may obtain the
draft guidance at http://www.fda.gov/FoodGuidances. This guidance, when
finalized, will provide industry with information on how to label beers
that are subject to FDA's labeling laws and regulations. This draft
guidance was issued in light of the ruling by the Alcohol and Tobacco
Tax and Trade Bureau (TTB) (formerly The Bureau of Alcohol, Tobacco,
and Firearms (ATF)) clarifying that certain beers do not meet the
definition of a ``malt beverage'' under the Federal Alcohol
Administration Act (the FAA Act). Because these beers are not subject
to the labeling provisions of the FAA Act, they are subject to the
labeling provisions of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) and the Fair Packaging and Labeling Act (FPLA). FDA, in the
draft guidance, also reminds manufacturers that the labeling of wine
beverages containing less than 7 percent alcohol by volume, such as
wine coolers, diluted wine beverages, dealcoholized or partially
dealcoholized wine and ciders, is also subject to FDA labeling
requirements.
As reflected in the 1987 Memorandum of Understanding between FDA
and TTB's predecessor Agency, the ATF (Ref. 1), TTB is responsible for
the issuance and enforcement of regulations with respect

[[Page 43336]]

to the labeling of distilled spirits, wines, and malt beverages under
the FAA Act.
The TTB has clarified that certain beers, which are not made from
both malted barley and hops but are instead made from substitutes for
malted barley (such as sorghum, rice, or wheat) or are made without
hops, do not meet the definition of a malt beverage under the FAA Act.
(See TTB Ruling 2008-3.) (Ref. 2). TTB stated in its ruling that such
products (other than sake, which is classified as a wine under the FAA
Act) are not subject to the labeling, advertising, and other provisions
of the TTB regulations issued under the FAA Act. Therefore, these beers
are subject to the labeling requirements under FDA's regulations.
However, as explained in the TTB ruling, some TTB labeling requirements
such as the Government Health Warning Statement under the Alcoholic
Beverage Labeling Act and certain marking requirements under the
Internal Revenue Code continue to apply to these products.
The guidance is intended to assist manufacturers in labeling beers
that are subject to FDA's labeling laws and regulations. In general,
FDA requires that food products under its labeling jurisdiction be
truthfully and informatively labeled in accordance with the FD&C Act
and the FPLA, and FDA's implementing regulations. These FDA labeling
requirements are explained in the guidance document.
In the August 17, 2009, notice, FDA published a request for public
comment on the proposed collection of information. FDA received one
letter in response to the notice, containing multiple comments. Several
comments in this letter were generally supportive of FDA's information
collection provisions in the guidance. Additional comments were outside
the scope of the four collection of information topics on which the
notice solicits comments and will not be discussed in this document.
(Comment 1) One comment stated that FDA should require alcohol
content labeling for the beers discussed in the guidance, including the
percent alcohol by volume (%ABV); the amount of alcohol (in fluid
ounces (oz) or grams) per serving; the definition of a ``standard
drink'' (i.e., 12 fluid oz of regular beer, 5 fluid oz of wine, or 1.5
fluid oz of 80-proof distilled spirits); the number of standard drinks
per container; and, the advice on moderate drinking, such as ``The
Dietary Guidelines for Americans recommends no more than one drink per
day for women, two drinks per day for men.'' The comment stated that
when a consumer sees a beverage such as ``sorghum beer'' or ``wheat
beer'' labeled the same way that all other FDA regulated beverages are
labeled, the consumer may not know that it is an alcoholic beverage.
(Response) FDA appreciates the concerns discussed in the comment.
As explained in the guidance, certain TTB labeling requirements apply
to these products. For example, these non-malt beers, like all alcohol
beverages, are required to bear the health warning statement under the
Alcoholic Beverage Labeling Act (27 U.S.C. 213-215). FDA's guidance
documents do not establish legally enforceable requirements, and
therefore cannot include mandatory language such as ``shall, must,
required, or requirement'' unless specific regulatory or statutory
requirements are cited. To the extent that the comment requests FDA to
engage in rulemaking, the comment is outside the scope of the comment
request on the four collection of information topics as they relate to
the provisions of the draft guidance document.
The guidance is intended to assist manufacturers in labeling beers
that are subject to FDA's labeling laws and regulations. All labeling
regulations discussed in this guidance have been previously approved by
OMB in accordance with the PRA under OMB control number 0910-0381. The
regulations approved under OMB control number 0910-0381 include
Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 (21 CFR
101.3, 101.4, 101.5, 101.9, 101.22, and 101.105). The proposed
information collection seeks to add manufacturers of certain beers that
do not meet the definition of a ``malt beverage'' under the FAA Act as
new respondents to these labeling regulations. The proposed information
collection also seeks OMB approval of allergen labeling of these beers
under section 403(w)(1) of the FD&C Act (21 U.S.C. 343(w)(1)), which
was added by the Food Allergen Labeling and Consumer Protection Act of
2004 (FALCPA).
Section 101.3 of FDA's food labeling regulations requires that the
label of a food product in packaged form bear a statement of identity,
(i.e., the name of the product), including as appropriate, the form of
the food or the name of the food imitated. Section 101.4 prescribes the
requirements for the declaration of ingredients on the label or
labeling of food products in packaged form, including using the common
or usual name of each ingredient. Section 101.5 requires that the label
of a food product in packaged form specify the name and place of
business of the manufacturer, packer, or distributor and, if the food
producer is not the manufacturer of the food product, its connection
with the food product. Section 101.9 requires that nutrition
information be provided for all food products intended for human
consumption and offered for sale, unless an exemption in Sec. 101.9(j)
applies to the product. Section 101.22 contains labeling requirements
for the disclosure of spices, flavorings, colorings, and chemical
preservatives (Sec. 101.22(j)) in food products. Section 101.105
specifies requirements for the declaration of the net quantity of
contents on the label of a food in packaged form.
Under the FD&C Act, as amended by the FALCPA, the food source name
of any ``major food allergen'' present must be declared (section
403(w)(1) of the FD&C Act). Section 201(qq) of the FD&C Act, (21 U.S.C.
321(qq)), defines ``major food allergen'' as milk, egg, fish,
Crustacean shellfish, tree nuts, wheat, peanuts, and soybeans, as well
as any food ingredient that contains protein derived from one of them,
with the exception of highly refined oils.
Description of respondents: The respondents to this collection of
information are manufacturers of beers that are subject to FDA's
labeling laws and regulations.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Third Party Disclosure Burden \1\
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Number of
Number of disclosures Total annual Average burden
Citation respondents per disclosures per disclosure Total hours
respondent
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21 CFR 101.3 and 101.22......... 12 2 24 0.5 12
21 CFR 101.4.................... 12 2 24 1 24
21 CFR 101.5.................... 12 2 24 0.25 6
21 CFR 101.9.................... 12 2 24 4 96

[[Page 43337]]

21 CFR 101.105.................. 12 2 24 0.5 12
Section 403(w)(1) of the FD&C 12 2 24 1 24
Act............................
Guidance document entitled 12 1 12 1 12
``Labeling of Certain Beers
Subject to the Labeling
Jurisdiction of the Food and
Drug Administration''..........
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Total....................... .............. .............. .............. .............. 186
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.

FDA's estimate of the number of respondents in table 1 is based on
the number of regulatory submissions submitted to TTB for beers that do
not meet the definition of a ``malt beverage'' under the FAA Act. Based
on its records of submissions received from manufacturers of such
products, TTB estimates the number of respondents to be 12 and the
number of disclosures annually to be 24. Thus, FDA adopts TTB's
estimate of 12 respondents, and an annual number of disclosures per
respondent of 2, in table 1 of this document.
FDA's estimate of the average burden per disclosure for each
regulation are based on FDA's experience with food labeling under the
Agency's jurisdiction. The estimated average burden per disclosure for
Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 in table 1
are equal to, and based upon, the estimated average burden per
disclosure approved by OMB in OMB control number 0910-0381. FDA further
estimates that the labeling burden of section 403(w)(1) of the FD&C
Act, which specifies requirements for the declaration of food
allergens, will be 1 hour based upon the similarity of the requirements
to that of Sec. 101.4. Finally, FDA estimates that a respondent will
spend 1 hour reading the guidance document.
Thus, FDA estimates that 12 respondents will each label 2 products
annually, for a total of 24 labels. FDA estimates that the
manufacturers will spend 7.25 hours (0.5 hours + 1 hour + 0.25 hour + 4
hours + 0.5 hour + 1 hour = 7.25 hours) on each label to comply with
FDA's labeling regulations and the requirements of section 403(w)(1) of
the FD&C Act, for a total of 174 hours (24 labels x 7.25 hours = 174
hours). In addition, 12 respondents will each spend 1 hour reading the
guidance document, for a total of 12 hours. Thus, FDA estimates the
total hour burden of the proposed collection of information to be 186
hours (174 hours + 12 hours = 186 hours).
The draft guidance also refers to previously approved collections
of information found in FDA regulations. The collections of information
in Sec. Sec. 101.3, 101.4, 101.5, 101.9, 101.22, and 101.105 have been
approved under OMB control number 0910-0381.

II. References

The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
(FDA has verified the Web site addresses, but we are not responsible
for any subsequent changes to the Web sites after this document
publishes in the Federal Register.)
1. Memorandum of Understanding 225-88-2000 between FDA and Bureau
of Alcohol, Tobacco and Firearms, available at http://www.fda.gov/AboutFDA/PartnershipsCollaborations/MemorandaofUnderstandingMOUs/DomesticMOUs/ucm116370.htm.
2. TTB Ruling 2008-3 dated July 7, 2008, available at http://www.ttb.gov/rulings/2008-3.pdf.

Dated: July 16, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18028 Filed 7-23-12; 8:45 am]
BILLING CODE 4160-01-P