21 U.S.C. § 350j Targeting of Inspection Resources For Domestic Facilities, Foreign Facilities, and Ports of Entry; Annual Report

• Library: United States Statutes
• Edition: 2023 Edition
• Currency: Current through P.L. 118-19 (published on www.congress.gov on 10/06/2023)

(a) Identification and inspection of facilities

(1) Identification

The Secretary 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 manufactured, processed, packed, or held at the facility.

(B) The compliance history of a facility, including with regard to food recalls, outbreaks of foodborne illness, and violations of food safety standards.

(C) The rigor and effectiveness of the facility's hazard analysis and risk-based preventive controls.

(D) Whether the food manufactured, processed, packed, or held at the facility meets the criteria for priority under section 381(h)(1) of this title.

(E) Whether the food or the facility that manufactured, processed, packed, or held such food has received a certification as described in section 381(q) or 384b of this title, as appropriate.

(F) Any other criteria deemed necessary and appropriate by the Secretary for purposes of allocating inspection resources.

(2) Inspections

(A) In general

Beginning on January 4, 2011, the Secretary shall increase the frequency of inspection of all facilities.

(B) Domestic high-risk facilities

The Secretary shall increase the frequency of inspection of domestic facilities identified under paragraph (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 shall ensure that each domestic facility that is not identified under paragraph (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 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), the Secretary shall inspect not fewer than twice the number of foreign facilities inspected by the Secretary 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 may rely on inspections conducted by other Federal, State, or local agencies under interagency agreement, contract, memoranda of understanding, or other obligation.