05-6346. Proposed Information Collection; Comment Request

AGENCY:

Alcohol and Tobacco Tax and Trade Bureau (TTB), Treasury.

ACTION:

Notice and request for comments.

SUMMARY:

The Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau, as part of its continuing effort to reduce paperwork and respondent burden, invites the public and other Federal agencies to comment on proposed and continuing information collections, as required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Currently, we are seeking comments on the TTB Questionnaire titled “Methanol Levels & Good Manufacturing Practices for Fruit Brandies.”

DATES:

We must receive your written comments on or before May 31, 2005.

ADDRESSES:

You may send comments to Jeffrey A. Salisbury, 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
• [e-mail] (e-mail).

Please reference the information collection's title in your comment. If you submit your comment via facsimile, send no more than five 8.5 x 11 inch pages in order to ensure electronic access to our equipment.

FOR FURTHER INFORMATION CONTACT:

To obtain additional information, copies of the information collection and its instructions, or copies of any comments received, contact Jeffrey A. Salisbury, Alcohol and Tobacco Tax and Trade Bureau, P.O. Box 14412, Washington, DC 20044-4412; or telephone [phone].

SUPPLEMENTARY INFORMATION:

Title: Methanol Levels & Good Manufacturing Practices for Fruit Brandies.

OMB Number: To be assigned.

Abstract: TTB has authority under the Internal Revenue Code of 1986, Title 26 U.S.C., and the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 201 et seq., over distilled spirits, wines, and malt beverage products. Section 105 of the FAA Act provides TTB with the authority to promulgate regulations regarding the labeling and advertising of alcohol beverages to provide consumers with adequate information concerning the identity and quality of such products.

TTB is proposing a voluntary collection of information from fruit brandy producers and importers to identify good manufacturing practices used in producing fruit brandies. Under the Memorandum of Understanding Between the Food and Drug Administration (FDA) and the Bureau of Alcohol, Tobacco and Firearms (TTB's predecessor agency), 52 FR 45502, November 30, 1987 (MOU), (still in force after the Homeland Security Act of 2002, which established TTB), TTB is responsible for testing alcohol beverages for the presence of substances, which if detected, may make the product adulterated under the Federal Food, Drug and Cosmetic Act of 1938, as amended, 21 U.S.C. 301, et seq. (FD & C Act). TTB may in certain instances seek a “health hazard evaluation” from FDA to determine if a particular alcohol beverage is adulterated under the FD & C Act. As a result of FDA's recommendations, TTB may take enforcement action against importers and manufacturers in cases involving adulterated alcohol beverages based upon violations of TTB laws.

With regard to methanol and fruit brandy specifically, FDA is responsible for issuing guidance on the safe level of methanol in fruit brandy marketed to consumers, while TTB is responsible for testing the level of methanol in fruit brandy to determine if it is adulterated under the FD & C Act. FDA is considering revising the maximum permitted level of methanol in fruit brandy, which is currently 0.35% by volume. Consequently, FDA is also considering revising or replacing their current guidance on fruit brandy (see Compliance Policy Guide (CPG) 7119.09, October 1, 1980). As part of this effort, FDA has requested TTB's assistance to identify current manufacturing practices in the production of brandy. Based on the information obtained in the survey, FDA may identify good manufacturing practices used to make fruit brandies and utilize such information in developing guidance for industry.

Accordingly, responses to the following questions will provide TTB with the required information to identify good manufacturing practices in the making of fruit brandy.

Questionnaire

1. Where is your distilled spirits plant(s) located?

2. On average, how much fruit brandy, by volume, do you produce in one year? (If you produce brandy from more than one fruit, please provide a breakdown of production volume by each type of fruit).

3. What percentage of fruit brandy produced by you is sold in the United States? (If you produce brandy from more than one fruit, please provide a breakdown of production volume by each type of fruit).

4. From what geographic location do you obtain the fruit used in the production of your fruit brandies?

5. What quality control procedures do you have in place regarding the fruit used in your brandy production? (i.e. inspections, age of fruit, condition requirements, washing, etc.)

6. How do you prepare the fruit to create the mash for fermentation?

7. Do you use any additional enzymes in the mash to aid in the fermentation? If so, please describe the specific enzymes that you are using.

8. Please describe the type of still you use in the production of your fruit brandies. (e.g. Pot, Alembic, Pot Rectified, Armagnac, Continuous, Other).

9. What is the degree of proof of your fruit brandies at distillation, before dilution and bottling?

10. In the case of brandies produced by pot still, what is the composite proof at distillation?

11. What is the heads/tails cutoff distillation and how do you determine the cutoff points?

12. What is your process for diluting the distillate in order to adjust the proof for bottling?

13. What is the proof of your finished product after bottling?

14. Are your fruit brandies aged before bottling? If yes, please describe the aging process and the aging period. Also, please indicate the proof of the product before and after aging.

15. What quality control practices do you use, other than those previously mentioned, to control the level of methanol in your finished fruit brandies?

16. Do you monitor the level of methanol in your fruit brandies? If you do monitor the level of methanol, describe your monitoring process and provide data on methanol levels for the past 3 years.

Current Actions: New information collection.

Type of Review: Regular.

Affected Public: Business or other for-profit.

Estimated Number of Respondents: 43.

Estimated Total Annual Burden Hours: 91.75.

Request for Comments

Comments submitted in response to this notice will be included or summarized in our request for Office of Management and Budget (OMB) approval of this information collection. All comments are part of the public record and subject to disclosure. Please do not include any confidential or inappropriate material in your comments.

We invite comments on: (a) Whether this information collection is necessary for the proper performance of the agency's functions, including whether the information has practical utility; (b) the accuracy of the agency's estimate of the information collection's burden; (c) ways to enhance the quality, utility, and clarity of the information collected; (d) ways to minimize the information collection's burden on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide the requested information.

Dated: March 25, 2005.

William H. Foster,

Chief, Regulations and Procedures Division.