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U.S Code last checked for updates: Nov 22, 2024
All Titles
Title 21
Chapter 9
Subchapter VIII
§ 384. Importation of prescripti...
§ 384b. Voluntary qualified impo...
§ 384. Importation of prescripti...
§ 384b. Voluntary qualified impo...
U.S. Code
Notes
§ 384a.
Foreign supplier verification program
(a)
In general
(1)
Verification requirement
Except as provided under subsections (e) and (f), each importer shall perform risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer or agent of an importer is—
(A)
produced in compliance with the requirements of
section 350g of this title
or
section 350h of this title
, as appropriate; and
(B)
is not adulterated under
section 342 of this title
or misbranded under
section 343(w) of this title
.
(2)
Importer defined
For purposes of this section, the term “importer” means, with respect to an article of food—
(A)
the United States owner or consignee of the article of food at the time of entry of such article into the United States; or
(B)
in the case when there is no United States owner or consignee as described in subparagraph (A), the United States agent or representative of a foreign owner or consignee of the article of food at the time of entry of such article into the United States.
(b)
Guidance
(c)
Regulations
(1)
In general
(2)
Requirements
The regulations promulgated under paragraph (1)—
(A)
shall require that the foreign supplier verification program of each importer be adequate to provide assurances that each foreign supplier to the importer produces the imported food in compliance with—
(i)
processes and procedures, including reasonably appropriate risk-based preventive controls, that provide the same level of public health protection as those required under
section 350g of this title
or
section 350h of this title
(taking into consideration variances granted under
section 350h of this title
), as appropriate; and
(ii)
section 342 of this title
and
section 343(w) of this title
.
1
1
So in original.
(B)
shall include such other requirements as the Secretary deems necessary and appropriate to verify that food imported into the United States is as safe as food produced and sold within the United States.
(3)
Considerations
(4)
Activities
(d)
Record maintenance and access
(e)
Exemption of seafood, juice, and low-acid canned food facilities in compliance with HACCP
This section shall not apply to a facility if the owner, operator, or agent in charge of such facility is required to comply with, and is in compliance with, 1 of the following standards and regulations with respect to such facility:
(1)
The Seafood Hazard Analysis Critical Control Points Program of the Food and Drug Administration.
(2)
The Juice Hazard Analysis Critical Control Points Program of the Food and Drug Administration.
(3)
The Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers standards of the Food and Drug Administration (or any successor standards).
The exemption under paragraph (3) shall apply only with respect to microbiological hazards that are regulated under the standards for Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers under part 113 of chapter
2
2
So in original. Probably should be “title”.
21, Code of Federal Regulations (or any successor regulations).
(f)
Additional exemptions
(g)
Publication of list of participants
(
June 25, 1938, ch. 675, § 805
, as added
Pub. L. 111–353, title III, § 301(a)
,
Jan. 4, 2011
,
124 Stat. 3953
.)
cite as:
21 USC 384a
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