---
kind: "section"
citation: "21 U.S.C. § 350j"
title: "21"
title_heading: "Food and Drugs"
number: "350j"
heading: "Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/350j"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter IV — Food"
---

# §350j. Targeting of inspection resources for domestic facilities, foreign facilities, and ports of entry; annual report

- (a) **Identification and inspection of facilities—**
  - (1) **Identification—** The [Secretary](/usc/21/321.md?p=d) shall identify high-risk facilities and shall allocate resources to inspect facilities according to the known safety risks of the facilities, which shall be based on the following factors:
    - (A) The known safety risks of the [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held at the facility.
    - (B) The compliance history of a facility, including with regard to [food](/usc/21/321.md?p=f) recalls, outbreaks of foodborne illness, and violations of [food](/usc/21/321.md?p=f) safety standards.
    - (C) The rigor and effectiveness of the facility’s hazard analysis and risk-based preventive controls.
    - (D) Whether the [food](/usc/21/321.md?p=f) manufactured, processed, packed, or held at the facility meets the criteria for priority under [section 381(h)(1) of this title](/usc/21/381.md?p=h-1).
    - (E) Whether the [food](/usc/21/321.md?p=f) or the facility that manufactured, processed, packed, or held such [food](/usc/21/321.md?p=f) has received a certification as described in section [381(q)](/usc/21/381.md?p=q) or [384b](/usc/21/384b.md) of this title, as appropriate.
    - (F) Any other criteria deemed necessary and appropriate by the [Secretary](/usc/21/321.md?p=d) for purposes of allocating inspection resources.
  - (2) **Inspections—**
    - (A) **In general—** Beginning on January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall increase the frequency of inspection of all facilities.
    - (B) **Domestic high-risk facilities—** The [Secretary](/usc/21/321.md?p=d) shall increase the frequency of inspection of domestic facilities identified under [paragraph (1)](#a-1) as high-risk facilities such that each such facility is inspected—
      - (i) not less often than once in the 5-year period following January 4, 2011; and
      - (ii) not less often than once every 3 years thereafter.
    - (C) **Domestic non-high-risk facilities—** The [Secretary](/usc/21/321.md?p=d) shall ensure that each domestic facility that is not identified under [paragraph (1)](#a-1) as a high-risk facility is inspected—
      - (i) not less often than once in the 7-year period following January 4, 2011; and
      - (ii) not less often than once every 5 years thereafter.
    - (D) **Foreign facilities—**
      - (i) **Year 1—** In the 1-year period following January 4, 2011, the [Secretary](/usc/21/321.md?p=d) shall inspect not fewer than 600 foreign facilities.
      - (ii) **Subsequent years—** In each of the 5 years following the 1-year period described in [clause (i)](#a-2-D-i), the [Secretary](/usc/21/321.md?p=d) shall inspect not fewer than twice the number of foreign facilities inspected by the [Secretary](/usc/21/321.md?p=d) during the previous year.
    - (E) **Reliance on Federal, State, or local inspections—** In meeting the inspection requirements under this subsection for domestic facilities, the [Secretary](/usc/21/321.md?p=d) may rely on inspections conducted by other Federal, [State](/usc/21/321.md?p=a-1), or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.
- (b) **Identification and inspection at ports of entry—** The [Secretary](/usc/21/321.md?p=d), in consultation with the [Secretary](/usc/21/321.md?p=d) of Homeland Security, shall allocate resources to inspect any article of [food](/usc/21/321.md?p=f) imported into the United States according to the known safety risks of the article of [food](/usc/21/321.md?p=f), which shall be based on the following factors:
  - (1) The known safety risks of the [food](/usc/21/321.md?p=f) imported.
  - (2) The known safety risks of the countries or regions of origin and countries through which such article of [food](/usc/21/321.md?p=f) is transported.
  - (3) The compliance history of the importer, including with regard to [food](/usc/21/321.md?p=f) recalls, outbreaks of foodborne illness, and violations of [food](/usc/21/321.md?p=f) safety standards.
  - (4) The rigor and effectiveness of the activities conducted by the importer of such article of [food](/usc/21/321.md?p=f) to satisfy the requirements of the foreign supplier [verification](/usc/21/360eee.md?p=28) program under [section 384a of this title](/usc/21/384a.md).
  - (5) Whether the [food](/usc/21/321.md?p=f) importer participates in the voluntary qualified importer program under [section 384b of this title](/usc/21/384b.md).
  - (6) Whether the [food](/usc/21/321.md?p=f) meets the criteria for priority under [section 381(h)(1) of this title](/usc/21/381.md?p=h-1).
  - (7) Whether the [food](/usc/21/321.md?p=f) or the facility that manufactured, processed, packed, or held such [food](/usc/21/321.md?p=f) received a certification as described in section [381(q)](/usc/21/381.md?p=q) or [384b](/usc/21/384b.md) of this title.
  - (8) Any other criteria deemed necessary and appropriate by the [Secretary](/usc/21/321.md?p=d) for purposes of allocating inspection resources.
- (c) **Interagency agreements with respect to seafood—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d) of Health and Human Services, the [Secretary](/usc/21/321.md?p=d) of [Commerce](/usc/21/360hh.md?p=4), the [Secretary](/usc/21/321.md?p=d) of Homeland Security, the Chairman of the Federal Trade Commission, and the heads of other appropriate agencies may enter into such agreements as may be necessary or appropriate to improve seafood safety.
  - (2) **Scope of agreements—** The agreements under [paragraph (1)](#c-1) may include—
    - (A) cooperative arrangements for examining and testing seafood imports that leverage the resources, capabilities, and authorities of each party to the agreement;
    - (B) coordination of inspections of foreign facilities to increase the percentage of imported seafood and seafood facilities inspected;
    - (C) standardization of data on seafood names, inspection records, and laboratory testing to improve interagency coordination;
    - (D) coordination to detect and investigate violations under applicable Federal law;
    - (E) a process, including the use or modification of existing processes, by which officers and employees of the National Oceanic and Atmospheric Administration may be duly designated by the [Secretary](/usc/21/321.md?p=d) to carry out seafood examinations and investigations under [section 381 of this title](/usc/21/381.md) or [section 203](/usc/21/203.md) of the [Food](/usc/21/321.md?p=f) Allergen [Labeling](/usc/21/321.md?p=m) and Consumer Protection Act of 2004;
    - (F) the sharing of information concerning observed non-compliance with United States [food](/usc/21/321.md?p=f) requirements domestically and in foreign nations and new regulatory decisions and policies that may affect the safety of [food](/usc/21/321.md?p=f) imported into the United States;
    - (G) conducting joint training on subjects that affect and strengthen seafood inspection effectiveness by Federal authorities; and
    - (H) outreach on Federal efforts to enhance seafood safety and compliance with Federal [food](/usc/21/321.md?p=f) safety requirements.
- (d) **Coordination—** The [Secretary](/usc/21/321.md?p=d) shall improve coordination and cooperation with the [Secretary](/usc/21/321.md?p=d) of Agriculture and the [Secretary](/usc/21/321.md?p=d) of Homeland Security to target [food](/usc/21/321.md?p=f) inspection resources.
- (e) **Facility—** For purposes of this section, the term “facility” means a domestic facility or a foreign facility that is required to register under [section 350d of this title](/usc/21/350d.md).

## Source credit

(June 25, 1938, ch. 675, § 421, as added Pub. L. 111–353, title II, § 201(a), Jan. 4, 2011, 124 Stat. 3923.)

## Notes

### Editorial Notes

### References in Text

Section 203 of the Food Allergen Labeling and Consumer Protection Act of 2004, referred to in subsec. (c)(2)(E), is section 203 of Pub. L. 108–282, Aug. 2, 2004, 118 Stat. 906, which amended sections 321, 343, and 343–1 of this title and enacted provisions set out as notes under sections 321 and 343 of this title.

### Statutory Notes and Related Subsidiaries

### Construction

Nothing in this section to be construed to apply to certain alcohol-related facilities, to alter jurisdiction and authorities established under certain other Acts, or in a manner inconsistent with international agreements to which the United States is a party, see sections 2206, 2251, and 2252 of this title.

### Advisory Committee Consultation

Pub. L. 111–353, title II, § 201(c), Jan. 4, 2011, 124 Stat. 3926, provided that: “In allocating inspection resources as described in section 421 of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 450j] (as added by subsection (a)), the Secretary may, as appropriate, consult with any relevant advisory committee within the Department of Health and Human Services.”