Christian BUTZKE Professor of Enology Purdue Wine Grape Team

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1 Christian BUTZKE Professor of Enology Purdue Wine Grape Team

2 Emergency Procedures Confined Space and CO 2 Lockout Procedures Ladders/Forklifts Personal Protection Chemicals Compressed Gases and Ozone

3 The Food Safety Modernization Act

4 FSMA & Wine TTB regulates alcohol beverages under the Federal Alcohol Administration Act and the Internal Revenue Code of 1986 FDA oversees the safety of food under the authority of the U.S. Federal Food, Drug, and Cosmetic Act, which was amended by the Food Safety Modernization Act in

5 Wine = Food! Alcoholic beverages, including wine, meet the definition of food under FSMA Wineries are exempt from majority of FSMA FDA has some jurisdiction: FSMA Section 116

6 FDA vs Wineries Registration requirements Inspection authority Mandatory recalls Import controls

7 Registration requirements Wineries (domestic facilities that manufacture, process, package or hold alcohol beverages for human consumption within the US), are required to register with FDA (Bioterrorism Act of 2002) Wineries must update their registration in accordance with FSMA every two years

8 FDA Inspection Authority Facilities of alcohol beverage producers are subject to FDA inspection authority over food manufacturing and processing facilities (21 CFR part 374)

9 FDA Inspection Authority Proper record-keeping procedures in place Adhere to Good Manufacturing Practices

10 FDA Mandatory Recalls FDA has authority over ingredient safety and adulteration issues pertaining to foods (including wine) It is TTB s position that wine found by FDA to be adulterated is mislabeled under the Federal Alcohol Administration Act TTB can recommend a mandatory recall of the adulterated wine

11 New Wine and Juice Treating Materials Part 24 of Title 27 of the Code of Federal Regulations (27 CFR part 24) Gum arabic Yeast mannoprotein Biotin Calcium pantothenate Chitin-glucan Chitosan Cellulase (β-glucanase) Folic Acid Inositol Magnesium Sulfate Niacin Polyvinyl-pyrrolidone (PVP)/imadazole (PVI) Potato protein isolate Pyridoxine Carboxymethyl cellulose Synthetic Tartaric Acid

12 FDA Import Controls It gives the FDA limited authority to set out regulations governing the treatment of imported products FSMA gives the FDA authority to establish a certification program for importers seeking to expedite the FDA s review of their facilities and products

13 Winemaking vs Winery Foods subject to a kill-step during processing (including pasteurization, distilling, fermenting or brewing) enjoy more limited oversight However, FSMA Section 116 (c) states: This section shall not be construed to exempt any food, other than alcoholic beverages

14 Winery Ancillary Products Selling juices and grapes to other wineries? Honey, verjuice, partially fermented juice? Crackers, cheese, meats, chocolates? Gift baskets? Pomace?

15 Does FSMA apply to pomace? Yes, if used as animal feed

16 FDA vs Wineries For further information, visit the FDA.gov Food page: Or contact the FDA Outreach and Information Center: SAFEFOOD

17

18 Wine & Health Dysentery BERLIN The Roman Empire

19 Wine & Health Wine vs. Food Poisoning? Escherichia coli O157:H7 (O-one-five-seven-H-seven) Salmonella enteritidis Listeria monocytogenes Campylobacter jejuni

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23 Questions?

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