April 4, 2003

CC-76, 249 AL:JNS

Ms. Leslye M. Fraser
Center for Food Safety and Applied Nutrition (HFS-4)
Food and Drug Administration
5100 Paint Branch Parkway
College Park, MD 20740

RE: Docket Nos. 02N-0276 and 02N-0278

Dear Ms. Fraser:

The Alcohol and Tobacco Tax and Trade Bureau (TTB) submits this comment in response to two notices of proposed rulemaking issued by the Food and Drug Administration (FDA). Both proposed rules implement provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), legislation directed at protecting the safety and security of the nation's food supply. For purposes of the Bioterrorism Act, the term "food" includes alcohol beverages.

TTB regulates the alcohol beverage industry and administers the licensing, labeling, taxation, trade practice, and related recordkeeping requirements imposed upon the industry by Federal law. Prior to issuing these proposed regulations, FDA sought public comments from stakeholders and other interested parties on the implementation issues arising under the Bioterrorism Act. Accordingly, in August 2002, TTB's predecessor agency sent a letter to FDA that identified many of these requirements and encouraged collaboration between the two agencies to avoid duplication of efforts and undue burden upon the alcohol beverage industry. The purpose of the letter was to inform FDA, in a general manner, of the comprehensive manner in which we regulate the alcohol beverage industry so FDA could determine whether our information serves the same or similar purpose and could be relied upon by FDA as it developed the proposed regulations. TTB has now reviewed the proposed regulations and offers more specific technical comments in this letter that respond to the details of the proposed rules.

Background

FDA's first proposed rule implements section 305 of the Bioterrorism Act, which requires the registration of domestic and foreign food facilities. Specifically, the Act requires the registration of "any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States." Foreign facilities must submit a registration that includes the name of the United States agent for the facility. In general, the owner, operator, or agent in charge of a facility is responsible for submitting the registration form to FDA.

The Bioterrorism Act provides that the registration must contain information necessary to notify the Secretary of Health and Human Services (HHS) of the name and address of each facility, trade names under which the facility conducts business and, when the Secretary of HHS deems necessary, the general food category of any food manufactured, processed, packed or held at such facility. Under the proposed regulations, the registrant must submit details such as emergency contact names with office and home telephone, cell and fax numbers, as well as comprehensive lists of trade names used by the facility. Registrants are required to notify the Secretary in a timely manner of changes to such information.

The second proposed rule would require U.S. purchasers or U.S. importers to submit to FDA prior notice of the importation of food by noon of the calendar day before the day of arrival. Section 307 of the Bioterrorism Act provides that the Secretary of HHS, after consultation with the Secretary of the Treasury, shall issue regulations implementing a prior notice requirement, for the purpose of enabling the inspection of food articles at ports of entry into the United States. The prior notice requirement applies to all articles of food that are being imported or offered for importation into the United States.

The statute provides that the notice shall identify the article, the manufacturer and shipper, the grower (if known within the time within which notice is required under regulations), the country of origin, the country from which the article is shipped, and the anticipated port of entry. Providing this notice is a condition of the article's admission in to the United States. FDA proposes that prior notice, amendments, and updates must be submitted electronically to FDA through FDA's Prior Notice System.

FDA's notices recognize that the statutory registration and prior notice requirements may result in facilities submitting duplicative information to more than one Federal agency. Accordingly, FDA seeks comments on whether its registration and prior notice requirements are duplicative of requirements imposed by other Federal agencies.

Existing Federal Requirements
Applicable to the Alcohol Beverage Industry

The Federal Alcohol Administration Act (FAA Act), 27 U.S.C. § 203, provides that it shall be unlawful, except pursuant to a basic permit issued by the Secretary of the Treasury, to engage in the business of importing, wholesaling, blending, or rectifying alcohol beverages, or producing distilled spirits or wine in the United States. A brewer is not required to hold a basic permit. The FAA Act and implementing regulations set forth the standards for issuing a basic permit, and condition such permits upon compliance with all Federal laws relating to alcohol. 27 U.S.C. § 204. This requirement is intended to protect the integrity of the industry by ensuring that only those persons who are likely to comply with the law enter the industry. Under the Internal Revenue Code of 1986 (IRC), TTB also qualifies the operations of distillers, wineries, and brewers and regulates their production activities.

As part of the application for a basic permit or qualification to operate, the industry member has to identify directors and officers of a corporation, certain shareholders, and individuals with powers of attorney. Industry members are also required to list all of their trade names on their basic permits. Brewers are required to list all of their trade names on their brewer's notice that is filed under the IRC in order to qualify to operate as a brewery. When a new trade name is used, the industry member is required to file an amended application for a basic permit or an amended brewer's notice.

With regard to imported alcohol beverages, the FAA Act requires that importers apply for and obtain a certificate of label approval (COLA) covering the bottled product before the product is released from customs custody for consumption. The COLA contains information about the importer and the alcohol beverage. It includes, among other things, the name and address of the importer, the brand name of the product, the class and type of the product, and a copy of the label. These COLA forms may be valid indefinitely, assuming that there is no change in the identity of the product or its importer, and can be used by the importer at any port of entry in the United States.

Overlap Between TTB and FDA Requirements

In many respects, the basic permit requirements of the FAA Act and the qualification to operate under the IRC achieve some of the same goals as the registration requirements of the Bioterrorism Act, and result in the collection of information such as addresses of facilities, identities of parent corporations, and trade names used by permittees. Currently, TTB does not collect the type of detailed emergency contact information proposed by FDA's notice. However, TTB would be happy to meet with FDA to discuss the possibility of amending our forms to collect this type of information, and ensure compatibility of data collection systems. If this can be done, it is possible that FDA can obtain the same information with regard to alcohol beverage permittees directly from TTB, instead of requiring these permittees to separately register with FDA. We encourage FDA to coordinate with us to minimize the regulatory burden on alcohol beverage industry members who already have permits from TTB.

It should be noted that FDA's proposed rules would cover some alcohol beverage producers and processors who are not required to obtain permits from TTB. For example, TTB requires importers to obtain basic permits; however, there is no permit requirement applicable to foreign producers whose alcohol beverages are imported into the United States. The Bioterrorism Act would require such foreign food facilities to register with FDA. While domestic producers of alcohol beverages are required to obtain permits or qualifications to operate from TTB under either the FAA Act or the IRC, the registration requirements of the Bioterrorism Act appear to reach domestic entities that would not be regulated under either of these statutes - for example, warehouses that merely store tax-paid alcohol beverages. The registration of these entities with FDA would not involve duplication of information collections; furthermore, TTB has no authority to require such entities to obtain permits.

With regard to the prior notice requirement, FDA's proposed rule regarding prior notice of imported food involves duplication issues primarily with Customs, rather than TTB. TTB's issuance of a certificate of label approval (COLA) does not constitute prior notice that a particular product is being imported into the United States on a particular date. Similarly, TTB's COLA database would not include some of the most important information sought by FDA, such as the entry type, U.S. Customs entry information, the anticipated arrival information, lot or code numbers, quantity in the shipment, or data concerning the identities of or contact information for the owner, consignee, or shipper.

FDA's proposed rule recognizes the desirability of coordinating its prior notice requirements with existing Customs requirements. FDA and Customs are cooperating in an effort to integrate these requirements by 2005. TTB encourages the expeditious integration of these requirements, to reduce the regulatory burdens on importers of alcohol beverages.

Conclusion

TTB has reviewed the requirements proposed by FDA to determine if they duplicate existing requirements under laws and regulations enforced by TTB. To the extent that such duplication exists, primarily with regard to the registration of alcohol beverage industry members who already have permits from TTB, we encourage FDA to coordinate with TTB to find ways to minimize regulatory burdens on those industry members. We also encourage the expeditious integration of information collections imposed by FDA and Customs with regard to prior notice of importations.

Thank you for allowing TTB the opportunity to comment on FDA's proposed regulations. TTB recognizes the importance of FDA's statutory mission to protect the integrity of the nation's food supply. As the agency responsible for the regulation of the alcohol beverage industry, TTB stands ready to assist FDA in any way possible.

Sincerely yours,

John J. Manfreda
Deputy Administrator