The U.S. Food and Drug Administration
(FDA) has determined that sulfating agents are human allergens that
can have serious health implications for persons who are allergic
to sulfites, particularly asthmatics, and, as a result, FDA
regulations require food labels to declare the presence of sulfites
if there are 10 parts per million (ppm) or more of a sulfating
agent in a finished food product. Under the Federal Alcohol
Administration Act (FAA Act) at 27 U.S.C. 205(e), the Secretary of
the Treasury is authorized to issue regulations requiring alcohol
beverage labels to provide “adequate information” to consumers
regarding the identity and quality of such products. Under that FAA
Act authority and consistent with FDA’s food labeling requirements,
the Alcohol and Tobacco Tax and Trade Bureau (TTB) alcohol beverage
labeling regulations in 27 CFR part 4 (wine), part 5 (distilled
spirits), and part 7 (beer) require a declaration of sulfites on
the labels of alcohol beverages released from domestic bottling
premises or customs custody when sulfites are present in such
products at levels of 10 or more ppm. This label disclosure is
necessary to protect sulfite-sensitive consumers from products that
potentially could be harmful to them.
US Code:
27
USC 205(e) Name of Law: Federal Alcohol Administration Act
There are no program changes
associated with this information collection. As for adjustments,
due to changes in agency estimates resulting from continued growth
in the number of alcohol beverage bottlers and importers regulated
by TTB, the number of respondents and annual responses to this
information collection is increased from 19,197 to 24,700, and its
estimated total annual burden is increased from 12,798 hours to
16,467.
On behalf of this Federal agency, I certify that
the collection of information encompassed by this request complies
with 5 CFR 1320.9 and the related provisions of 5 CFR
1320.8(b)(3).
The following is a summary of the topics, regarding
the proposed collection of information, that the certification
covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a
benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control
number;
If you are unable to certify compliance with any of
these provisions, identify the item by leaving the box unchecked
and explain the reason in the Supporting Statement.