This new regulation pertains only to facilities that manufacture/process, pack, or hold food, as defined in the regulation, for consumption in the U.S. Examples of "food" include:

• Dietary supplements and dietary ingredients
• Infant formula
• Beverages (including alcoholic beverages and bottled water)
• Fruits and vegetables
• Fish and seafood
• Dairy products and shell eggs
• Raw agricultural commodities for use as food or components of food
• Canned and frozen foods
• Bakery goods, snack food, and candy (including chewing gum)
• Live food animals
• Animal feeds and pet food

http://www.cfsan.fda.gov/~dms/fsbtac12.html