> August 30, 2002

Dockets Management Branch (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

RE: (1) Section 303 -- Docket No. 02N-0275 (Detention)

(2) Section 305 -- Docket No. 02N-0276 (Registration)

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(2) Section 306 -- Docket No. 02N-0277 (Recordkeeping)

(3) Section 307 -- Docket No. 02N-0278 (Prior Notice)

Dear Sir/Madam:

The undersigned are a coalition of trade associations (see Attachment A)
representing all tiers of the beverage alcohol industry. Members of our
associations are involved in the production, importation,
distribution/wholesaling, and retailing of beverage alcohol products
that are sold throughout the United States.

On behalf of our respective members, we welcome the opportunity to
provide initial comments concerning the Food and Drug Administration's
(FDA) proactive efforts to liaise with the foods community in
implementing the provisions of the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Act). We fully
support this FDA initiative, which is designed to create a focused
regulatory scheme that does not unnecessarily duplicate existing
statutory and/or regulatory requirements currently in place. To that
end, our comments focus upon how the directives of the above-referenced
Sections of the Act already are met and satisfied by the existing
extensive regulatory scheme governing beverage alcohol.

Since the 1930s, the Bureau of Alcohol, Tobacco and Firearms (BATF) and
its predecessor agencies have regulated the beverage alcohol industry in
terms of both import and domestic trade.[^1] BATF has a comprehensive
set of regulations that governs the production, manufacture,
importation, and distribution of beverage alcohol products. All persons
engaged in the business of producing, importing and distributing
beverage alcohol products in the United States must obtain a permit from
BATF or be registered with BATF. The beverage alcohol industry also is
governed by an extensive regulatory scheme administered by BATF, which,
among other things, requires industry members to strictly account for
all products. Simply put, the existing regulations enforced by BATF more
than satisfy the provisions of this Act.

Food and Drug Administration

August 30, 2002

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In addition, industry members involved in the production, importation
and distribution of beverage alcohol products are licensed by each State
in which they do business. Each State also has regulations that require
recordkeeping and mandate the filing of periodic reports of beverage
alcohol products shipped into and/or sold in that State. Although
excluded from the scope of the Act, beverage alcohol retailers also are
licensed by the States in which they do business.

The U.S. Customs Service further regulates importers of beverage alcohol
products. Importers must maintain records to establish upon request that
goods imported have been classified correctly, taxes have been paid, and
the importer of record has complied with all regulations specifically
dealing with beverage alcohol. Further, as discussed more fully below,
Customs has several initiatives in place, such as the Container Security
Initiative, that requires extensive information about U.S. bound
shipments at least 24 hours before the vessel sails to the United
States.

We urge FDA to avoid proposing or adopting regulations that would be
duplicative of regulations already in place and administered by other
federal agencies. In that regard, Sections 302(c) and 314 clearly
contemplate and direct the efficient use of government resources to
effectuate the goals of this Act and to facilitate its implementation by
a clear allocation of federal agency activities. This clear allocation
of responsible action among federal agencies, such as BATF and the
Customs Service vis-à-vis their respective regulatory schemes governing
beverage alcohol, will best utilize the procedures and processes already
in place to most efficiently "develop a crisis communications and
education strategy with respect to bioterrorist threats to the food
supply," the stated purpose of Title III of the Act.

Duplicative regulations and unnecessary regulations are costly and
create inefficiencies, as well as spawn potential confusion within the
regulated community. Further, such measures impose unnecessary burdens
upon regulators and the regulated community and thereby divert valuable
time and resources away from government and industry efforts to protect
the food supply from bioterrorist threats \-- an objective that all of
us fully support.

Finally, we urge that the resources and appropriations allocated to
implement the Act be available to the federal agencies, such as BATF,
that are a critical component in effectuating its provisions. In
addition, such agencies also should have available the necessary
resources and funds to meet various procedural elements of the Act, such
as the electronic filing directive set forth in Section 305(d).

The following are our comments regarding specific Sections of the Act.

# Section 303 -- Administrative Detention

No person can hold a federal permit to produce, import or distribute
beverage alcohol if that person has been convicted of a felony within
five years prior to the date of application or within three years of the
date of application to have been convicted of a misdemeanor relating to
beverage alcohol. Without a permit, importers, distillers, vintners, and
distributors cannot

Food and Drug Administration

August 30, 2002

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engage in the beverage alcohol business. Permits can be revoked or
suspended for reasons specified in federal law. The current permit
system for beverage alcohol producers, importers and
wholesalers/distributors is far more restrictive and gives the
government greater control than anything contemplated in instant Act.

# Section 305 -- Registration of Food Facilities

Requiring a producer, importer, or distributor of beverage alcohol to
register with FDA would be a duplication of existing licensing and/or
permit requirements. All importers, domestic producers and
wholesalers/distributors of beverage alcohol must obtain a permit from
the federal government. While brewers are not required to obtain a
permit, they must register with BATF. Any applicant for a permit or
registration with BATF must go through extensive background and
financial investigations. Foreign producers can only import beverage
alcohol through an entity that holds a Federal Basic Importer's Permit.

# Section 306 -- Maintenance and Inspection of Records for Foods

Under current federal laws and regulations, importers, producers and
distributors/ wholesalers of beverage alcohol must maintain "one up and
one down" records. During normal business hours, these records must be
kept and made available for review by a federal officer. The objectives
of Section 306 are met or exceeded by current BATF recordkeeping
requirements/regulations. Any additional recordkeeping requirement by
FDA would be duplicative and unnecessary.

# Section 307 -- Prior Notice of Imported Food Shipment

The U.S. Customs Service already receives advance notice of the arrival
of a ship and of the ship's manifest well in advance of the ship's
arrival. Given the Customs Service's various security initiatives, there
is no need for FDA to issue more regulations that would require
something already required by the U.S. Customs Service. For example,
Customs is in the process of finalizing its new requirements that would
require ocean carriers and non-vessel-operating common carriers to
present detailed cargo manifests 24 hours before a container is loaded
onto a ship. Shippers -- food importers -- play a crucial role in
satisfying these requirements.

The Custom's checklist requires fifteen (15) information elements that
are far more detailed than the directives of the Act. These information
elements are: (1) foreign port of departure; (2) carrier SCAC code; (3)
voyage number; (4) date of scheduled arrival in first U.S. port; (5)
numbers and quantities from carrier's master or house bill of lading;
(6) first port of loading, or first port of receipt, of the cargo by the
inbound carrier; (7) a precise description (or the Harmonized Tariff
Schedule numbers if the HTS classification is provided by the shipper)
and weight of the cargo, or, if the container is sealed, the shipper's
declared description and weight of the cargo (generic descriptions,
specifically freight-all-kinds, general cargo, and STC (said to contain)
are not acceptable); (8) shipper's name and address, or an
identification number, from all bills of lading; (9) consignee's name
and address, or the owner's or owners' representative's name and
address, or an identification number, from all bills of lading; (10)
advise Customs when actual boarded quantities do not equal quantities
indicated on the relevant bills of lading (carriers

Food and Drug Administration

August 30, 2002

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are not required to verify quantities in sealed containers); (11) vessel
name, national flag and vessel number; (12) foreign country of origin
where cargo is loaded onto vessel; (13) hazardous-material indicator;
(14) container number (for containerized shipments); and (15) seal
number affixed to container.

Customs' efforts to improve security impose requirements beyond the
dictates set forth in the Act. U.S. companies must educate their
suppliers not only about the new manifest rules referenced above, but
also about the Customs-Trade Partnership Against Terrorism (C-TPAT) and
other security measures. Although technically a voluntary program,
C-TPAT is becoming an industry standard.

[Conclusion]{.underline}

In summary, we recommend that FDA meet with other agencies that have
regulations and jurisdictions to govern the importation, production and
distribution of beverage alcohol in order to coordinate
responsibilities. Such a liaison will avoid duplication of government
resources, government manpower and government regulation. We submit that
this suggested course of action will enable the federal government and
the food industry to focus their resources more efficiently and
effectively upon efforts that will enhance security and will avoid
unnecessary and redundant burdens that otherwise could be imposed upon
both enforcement and compliance efforts.

Thank you for the opportunity to present our views concerning FDA's
actions to implement the Bioterrorism Act. We stand ready to work with
you at any time to assist FDA in the development of implementing
regulations that will result in the efficient and effective
implementation of this Act. If we can be of any further assistance,
please do not hesitate to call on us.

> Sincerely,

Arthur DeCelle, Executive Vice President & General Counsel

Beer Institute

C. M. Wendell Lee, General Counsel

Wine Institute

Donald MacVean, Executive Director

The Presidents' Forum

Robert J. Maxwell, President

National Association of Beverage Importers, Inc.

Bill Nelson, Vice President - Government Relations

American Vintners Association

Lynne J. Omlie, Senior Vice President & General Counsel

Distilled Spirits Council of the United States, Inc.

David K. Rehr, President

National Beer Wholesalers Association

Harry Wiles, Executive Director

American Beverage Licensees

Craig Wolf, General Counsel

Wine and Spirits Wholesalers of America, Inc.

Attachment A

Arthur DeCelle, Executive Vice President & General Counsel

Beer Institute (BI)

121 C Street, N.W., Suite 750

Washington, D.C. 20001

\(202\) 737-2337 · (202) 737-7004 (fax)

C. M. Wendell Lee, General Counsel

Wine Institute (WI)

425 Market Street, Suite 1000

San Francisco, CA 94105

\(415\) 512-0151 · (415) 442-0742 (fax)

Donald MacVean, Executive Director

The Presidents' Forum

643 Snow Goose Lane

Annapolis, MD 21401

\(410\) 349-4037 · (410) 349-3346 (fax)

Robert J. Maxwell, President

National Association of Beverage Importers, Inc. (NABI)

30 Courthouse Square, Suite 300

Rockville, MD 20850

\(240\) 453-9998 · (240) 453-9358 (fax)

Bill Nelson, Vice President - Government Relations

American Vintners Association (AVA)

1200 G Street, N.W., Suite 360

Washington, D.C. 20005

\(202\) 783-2756 · (202) 347-6342 (fax)

Lynne J. Omlie, Senior Vice President & General Counsel

Distilled Spirits Council of the United States, Inc. (DISCUS)

1250 Eye Street, N.W.

Washington, D.C. 20005

\(202\) 682-8824 · (202) 682-8888 (fax)

David K. Rehr, President

National Beer Wholesalers Association (NBWA)

1100 South Washington Street

Alexandria, VA 22314

\(703\) 683-4300 · (703) 683-8965 (fax)

Harry Wiles, Executive Director

American Beverage Licensees (ABL)

5101 River Road, Suite 108

Bethesda, MD 20816

\(301\) 656-1494 · (301) 656-7539 (fax)

Craig Wolf, General Counsel

Wine and Spirits Wholesalers of America, Inc. (WSWA)

805 15^th^ Street, N.W. Suite 430

Washington, D.C. 20005

\(202\) 371-9792 · (202) 789-2405 (fax)

[^1]: [See generally]{.underline}, Federal Alcohol Administration Act,
    27 U.S.C. §§ 121-211, Internal Revenue Code 26 U.S.C. §§ 5001-5691,
    and Title 27, Code of Federal Regulations.