(1) Each product a brewer or beer importer desires to sell in the state of Montana must be approved by the department and conform to the provisions of ARM 42.13.201.

(2) A brewer of malted beverages who has an annual nationwide production of less than 10,000 barrels is exempt from the requirements in (3).

(3) In order to consider the product for approval, the department must receive copies of:

(a) the primary packaging unless a traditional container is used. Traditional containers include aluminum cans, glass bottles, kegs, and boxes that are typically associated with alcoholic beverages. Any change to the primary packaging must be approved by the department prior to entering the Montana market if a nontraditional container is used; and

(b) the Certificate of Label Approval for products that are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB). Any change to the label that requires approval from the TTB must be approved by the department prior to the product entering the Montana market; or

(c) the label for products that are regulated by the U.S. Food and Drug Administration. Any changes to the label must be approved by the department prior to entering the Montana market.

(4) Beer containing more than 8.75 percent but not more than 14 percent alcohol by volume must:

(a) be approved by the department prior to being sold or distributed within the state;

(b) be made by the alcoholic fermentation of an infusion or decoction, or a combination of both, in potable brewing water, of malted cereal grain, in which the sugars used for fermentation of the alcoholic beverage are at least 75 percent derived from malted cereal grain measured as a percentage of the total dry weight of the fermentable ingredients; and

(c) note the alcohol content by volume on the label.

(5) To obtain approval from the department for all beer or formula changes that meet the criteria in (4), the following documents are required:

(a) The brewer or beer importer must file a form, supplied by the department, attesting that the formula meets the requirements in (4).

(b) If the brewer or beer importer is required by federal law or regulations to file its formula with TTB, the brewer or beer importer is also required to send a copy of the formula filed with the TTB to the department.

(c) At the department's request and sole discretion, brewers or beer importers must file a formula for verification of its compliance with Montana statutes.

(d) All formulas filed with the department are protected by the privacy act and will not be released by the department unless otherwise required by law or by court order.

(6) The department will process the request and provide approval or denial in writing within 30 days of receipt of all required information.