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美國食品安全現代化法淺析
371
由第三方驗證機構透過不同稽核措施，判定外國食品業者設施是否
符合美國食品安全標準與規定，並發放驗證證書。而第三方驗證機
構得為個人或組織，亦得為外國政府機關或代表、外國商業協會、
或其他經
FDA
認許為適當者。
112
除此之外，
FSMA
要求
FDA
在新
法頒布後的
18
個月內制定模範認證標準，包括對稽核報告之監管
要求，以及各經認許之認證機構均應確保第三方稽核員或驗證機構
及其代理人符合該標準。
113
然而，
FDA
均未於法定時限內制定施
行細則或模範標準。
FSMA
將稽核
(
audit
)
依其目的分為兩種類型，第一類為諮詢
性稽核
(
consultative audit
)，目的在於協助食品業者判斷其是否符合
FSMA
相關規定，稽核結果僅供食品業者參考。
114
第二類則為管制
性稽核
(
regulatory audit
)，目的在於確認食品業者是否符合
FSMA
相關規定，此稽核結果可用以判定進口食品得否依第
801
(
q
)
條取
creditation, FDA] has determined meets the applicable requirements of this subpart
and is accredited to conduct food safety audits and to issue food or facility certifi-
cations to eligible entities. An accredited third-party certification body has the same
meaning as accredited third-party auditor as defined in section 808[a]
[
4] of the
FD&C Act.”
)
其中，所謂直接認證即係指由
FDA
對第三方驗證機構所作成之認
證。
Id.
(
“
Direct accreditation
means accreditation of a third-party certification body
by FDA.”
)
112
Id.
(
“
Third-party certification body
has the same meaning as third-party auditor as
that term is defined in section 808[a]
[
3] of the FD&C Act and means a foreign
government, agency of a foreign government, foreign cooperative, or any other
third party that is eligible to be considered for accreditation to conduct food safety
audits and to certify that eligible entities meet the requirements of the FD&C Act. A
third-party certification body may be a single individual or an organization. Once
accredited, a third-party certification body may use audit agents to conduct food
safety audits.”
)
113
21 U.S.C. 384d
(
b
)(
2
)
(
as amended by FSMA § 307
)
.
114
21 U.S.C. 384d
(
a
)(
5
)
(
as amended by FSMA § 307
)
.