21 USC 350k - Laboratory accreditation for analyses of foods

U.S Code last checked for updates: May 21, 2025

§ 350k.

Laboratory accreditation for analyses of foods

(a)

Recognition of laboratory accreditation

(1)

In general

Not later than 2 years after January 4, 2011, the Secretary shall—

(A)

establish a program for the testing of food by accredited laboratories;

(B)

establish a publicly available registry of accreditation bodies recognized by the Secretary and laboratories accredited by a recognized accreditation body, including the name of, contact information for, and other information deemed appropriate by the Secretary about such bodies and laboratories; and

(C)

require, as a condition of recognition or accreditation, as appropriate, that recognized accreditation bodies and accredited laboratories report to the Secretary any changes that would affect the recognition of such accreditation body or the accreditation of such laboratory.

(2)

Program requirements

(3)

Increasing the number of qualified laboratories

(4)

Limited distribution

(5)

Foreign laboratories

(6)

Model laboratory standards

The Secretary shall develop model standards that a laboratory shall meet to be accredited by a recognized accreditation body for a specified sampling or analytical testing methodology and included in the registry provided for under paragraph (1). In developing the model standards, the Secretary shall consult existing standards for guidance. The model standards shall include—

(A)

methods to ensure that—

(i)

appropriate sampling, analytical procedures (including rapid analytical procedures), and commercially available techniques are followed and reports of analyses are certified as true and accurate;

(ii)

internal quality systems are established and maintained;

(iii)

procedures exist to evaluate and respond promptly to complaints regarding analyses and other activities for which the laboratory is accredited; and

(iv)

individuals who conduct the sampling and analyses are qualified by training and experience to do so; and

(B)

any other criteria determined appropriate by the Secretary.

(7)

Review of recognition

To ensure compliance with the requirements of this section, the Secretary—

(A)

shall periodically, and in no case less than once every 5 years, reevaluate accreditation bodies recognized under paragraph (1) and may accompany auditors from an accreditation body to assess whether the accreditation body meets the criteria for recognition; and

(B)

shall promptly revoke the recognition of any accreditation body found not to be in compliance with the requirements of this section, specifying, as appropriate, any terms and conditions necessary for laboratories accredited by such body to continue to perform testing as described in this section.

(b)

Testing procedures

(1)

In general

Not later than 30 months after January 4, 2011, food testing shall be conducted by Federal laboratories or non-Federal laboratories that have been accredited for the appropriate sampling or analytical testing methodology or methodologies by a recognized accreditation body on the registry established by the Secretary under subsection (a)(1)(B) whenever such testing is conducted—

(A)

by or on behalf of an owner or consignee—

(i)

in response to a specific testing requirement under this chapter or implementing regulations, when applied to address an identified or suspected food safety problem; and

(ii)

as required by the Secretary, as the Secretary deems appropriate, to address an identified or suspected food safety problem; or

(B)

on behalf of an owner or consignee—

(i)

in support of admission of an article of food under section 381(a) of this title; and

(ii)

under an Import Alert that requires successful consecutive tests.

(2)

Results of testing

(3)

Exception

The Secretary may waive requirements under this subsection if—

(A)

a new methodology or methodologies have been developed and validated but a laboratory has not yet been accredited to perform such methodology or methodologies; and

(B)

the use of such methodology or methodologies are necessary to prevent, control, or mitigate a food emergency or foodborne illness outbreak.

(c)

Review by Secretary

(d)

No limit on Secretarial authority

(June 25, 1938, ch. 675, § 422, as added Pub. L. 111–353, title II, § 202(a), Jan. 4, 2011, 124 Stat. 3926.)

cite as: 21 USC 350k