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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

)

.