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366
歐美研究
要求。
87
就定義而言，施行細則將小型進口商定義為近三年年度銷
售營業額在
100
萬以下之人類食品進口商，或近三年年度銷售營業
額在
250
萬以下之動物食品進口商；
88
小型供應商之年度銷售額上
限亦同。
89
首先，欲申請豁免外國供應商查證要求之進口商，每年
應繳交資料證明其符合小型進口商之定義，或其所合作之供應商符
合小型供應商之定義。相較於一般進口商須執行之外國供應商查證
措施，符合前述定義者，將無須進行耗費時間金錢且專業需求度高
之危害分析、風險評估等要求。惟此類進口商仍須於進口前或進口
後兩年內提供書面保證
(
written assurance
)，對其外國供應商所執行
之食品安全控制程序簡短說明、保證其外國供應商所製造食品符合
FDCA
規定，並由合格人員執行相關措施。
90
若進口商認為進口食
品之產製流程不符書面保證內容，須迅速採取適當改正措施。
91
87
Id.
§ 1.512.
88
Id.
§ 1.500
(
“
Very small importer means
: [1] With respect to the importation of
human food, an importer [including any subsidiaries and affiliates] averaging less
than $1 million per year, adjusted for inflation, during the 3-year period preceding
the applicable calendar year, in sales of human food combined with the U.S. market
value of human food imported, manufactured, processed, packed, or held without
sale [
e.g.,
imported for a fee]; and [2] With respect to the importation of animal food,
an importer [including any subsidiaries and affiliates] averaging less than $2.5 million
per year, adjusted for inflation, during the 3-year period preceding the applicable
calendar year, in sales of animal food combined with the U.S. market value of animal
food imported, manufactured, processed, packed, or held without sale [
e.g.,
im-
ported for a fee.]”
)
89
Id
.
(
“Very small foreign supplier means a foreign supplier, including any subsidiary,
affiliate, or subsidiaries or affiliates, collectively, of any entity of which the foreign
supplier is a subsidiary or affiliate, whose average annual monetary value of sales of
food during the previous 3-year period [on a rolling basis] is no more than $1 million,
adjusted for inflation.”
)
.
90
Id.
§§ 1.512
(
a
)
-
(
b
)
.
91
Id.
§ 1.512
(
b
)(
4
)
.