21 U.S.C. § 350k: Laboratory accreditation for…

Summary

The Secretary must set up a program to make sure food testing is done by accredited laboratories. Within 2 years after January 4, 2011 the Secretary must create the program, keep a public list of recognized accreditation bodies and the labs they accredit, and require those bodies and labs to report any changes that affect their status. The program must recognize accreditation bodies that meet the Secretary’s criteria and work to increase the number of qualified labs beyond those available on January 4, 2011. The Secretary can limit how the public list is shared for national security reasons. Accreditation bodies may approve labs outside the United States if they meet the same standards. The Secretary will write model standards for lab accreditation covering proper sampling and testing methods (including quick tests), quality systems, complaint handling, and training for people who do the testing. Recognized accreditation bodies must be reviewed at least once every 5 years, and the Secretary must revoke recognition if they do not meet the rules. By 30 months after January 4, 2011, testing required under this law must be done by Federal labs or non‑Federal labs that are accredited by a recognized body on the public list when testing is done for owners or consignees to address a known or suspected food safety problem, to meet Secretary requirements, to support food admission, or under certain import alerts. Test results must be sent to the Food and Drug Administration unless the Secretary exempts them. The Secretary may temporarily allow a new validated test method before labs are accredited if needed for an emergency. If a State‑run, accredited lab leads to a State recall, the Secretary will review the results to decide if a national recall or other action is needed. Nothing here limits the Secretary’s power to act on food testing information.

Title 21, §350k

Food and Drugs, Source: USLM XML via OLRC

(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

The program established under paragraph (1)(A) shall provide for the recognition of laboratory accreditation bodies that meet criteria established by the Secretary for accreditation of laboratories, including independent private laboratories and laboratories run and operated by a Federal agency (including the Department of Commerce), State, or locality with a demonstrated capability to conduct 1 or more sampling and analytical testing methodologies for food.

(3)Increasing the number of qualified laboratories

The Secretary shall work with the laboratory accreditation bodies recognized under paragraph (1), as appropriate, to increase the number of qualified laboratories that are eligible to perform testing under subparagraph (b) beyond the number so qualified on January 4, 2011.

(4)Limited distribution

In the interest of national security, the Secretary, in coordination with the Secretary of Homeland Security, may determine the time, manner, and form in which the registry established under paragraph (1)(B) is made publicly available.

(5)Foreign laboratories

Accreditation bodies recognized by the Secretary under paragraph (1) may accredit laboratories that operate outside the United States, so long as such laboratories meet the accreditation standards applicable to domestic laboratories accredited under this section.

(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

The results of any such testing shall be sent directly to the Food and Drug Administration, except the Secretary may by regulation exempt test results from such submission requirement if the Secretary determines that such results do not contribute to the protection of public health. Test results required to be submitted may be submitted to the Food and Drug Administration through electronic means.

(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

If food sampling and testing performed by a laboratory run and operated by a State or locality that is accredited by a recognized accreditation body on the registry established by the Secretary under subsection (a) result in a State recalling a food, the Secretary shall review the sampling and testing results for the purpose of determining the need for a national recall or other compliance and enforcement activities.

(d)No limit on Secretarial authority

Nothing in this section shall be construed to limit the ability of the Secretary to review and act upon information from food testing, including determining the sufficiency of such information and testing.

Notes & Related Subsidiaries

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 section 2206, 2251, and 2252 of this title.

§350k Laboratory Accreditation for Analyses of Foods

Summary

Title 21, §350k

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Construction

Citations & Metadata