No. A farm located in a foreign country that ships food directly to the United States is exempt
from the registration requirements of section 415 of the FD&C Act (21 U.S.C. 350d; 21 CFR
1.227). However, if prior to shipping to the United States, the farm ships the food to a foreign
facility that manufactures/processes, packs, or holds the food, the second facility must register
unless the food subsequently undergoes further manufacturing/processing of more than a de
minimis nature at another foreign facility (21 CFR 1.226(a)). The de minimis provision (21 CFR
1.226) is discussed further in Question C.3.5 in this document.
