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w w w. v w m m e d i a . c o m J a n - F e b 2 015 | V I N E YA R D & W I N E RY M A N A G E M E N T 8 9 tion, wheat gluten, which can be a part of wine barrel head construc- tion, may also be considered. TTB PROPOSED RULES When the FDA implemented mandatory allergen labeling through FALCPA in 2004, the ball was squarely in the TTB court to extend the mandatory allergen labeling to alcoholic beverages. After discus- sions with the FDA and publishing an advance notice of rulemaking in April 2005, the TTB composed and published Notice No. 62 in July 2006 in which it reviewed the comments submitted in response to the 2005 proposed rulemaking and then outlined its proposed rule changes. Citing the Federal Alcohol Administration Act's designation of labeling regulation authority to the TTB, as well as a House of Repre- sentatives committee expectation that TTB work in cooperation with FDA to regulate alcohol beverage allergen labeling, TTB proposed adoption of mandatory allergen labeling standards. The TTB review of comments r e c e i v e d i n r e s p o n s e t o t h e advance notice of rulemaking of FALCPA was complete with the assertion that the proposed regu- lations treat major food allergens used as fining or processing agents in the same way as any other major food allergen used in the produc- tion of an alcoholic beverage. I n r e s p o n s e t o c o m m e n t s regarding the setting of thresholds for each major food allergen, TTB backed away from setting thresh- olds, thus removing a quantitative aspect from the proposal with the caveat that the threshold issue may be revisited in the future as more accurate scientific data become available. In a written response to TTB Notice No. 62, dated Dec. 26, 2006, the Wine Institute partnered with WineAmerica in representing more than 1,800 industry members in summarizing the legal, scientific and international aspects of aller- gen labeling and extending the April 2005 included an observation that the vast majority, including a multitude of trade organizations and health and medical associa- tions, favored mandatory labeling of the major food allergens. Indeed, many of the same concerns for public safety were reiterated in both the proposed rulemaking as well as the submitted comments. In response to a solicitation for industry comments concerning industry costs versus consumer benefits, comments of industry c o n c e r n w e r e d i s m i s s e d w i t h little regard for industry perspec- t i v e , w h i l e a s i n g l e a c a d e m i c commenter's suggestions were combined with unsubstantiated individual consumer allergic reac- tion reports to uphold the proposed rulemaking with no modifications. Processing and fining agents were specifically addressed and alignment of the proposed rule with + Allergen labeling is moving closer to becoming manda- tory in the U.S. + Of the eight foods recog- nized by the FDA as com- mon allergens, three are used in winemaking: milk, eggs and fish. + Allergens can be analyzed by many methods, including PCR, ELISA, LC-MS and LC- MS-MS multiplex detection. + There are two vegetal pro- teins from source materials that are not currently listed as major allergens by FDA or other worldwide regula- tory agencies. AT A GLANCE