21 U.S.C. § 350k — Laboratory accreditation for analyses of foods

submitted 88 years ago by Pub. L. 111-353 to r/title-21-FOOD-AND-DRUGS · 942 words · no verdicts yet

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The FDA must build a program that accredits labs to test food safety. Certain legally required food tests must use accredited labs on a public registry. The Secretary reviews accreditation bodies periodically and keeps full authority to act on any test results.

(a) Recognition of laboratory accreditation: (1) Within 2 years of January 4, 2011, the Secretary must (A) create a program for food testing by accredited laboratories; (B) create a public registry of recognized accreditation bodies and the labs they've accredited, including names, contact information, and other relevant details; and (C) require accreditation bodies and accredited labs to report any changes that would affect their recognition or accreditation. (2) The program must recognize accreditation bodies that meet the Secretary's criteria, including bodies that accredit independent private labs and labs run by a federal agency (including Commerce), a state, or a locality with a demonstrated ability to do food sampling and testing. (3) The Secretary must work with recognized accreditation bodies to increase the number of qualified labs beyond the number that existed on January 4, 2011. (4) For national security, the Secretary, coordinating with Homeland Security, may decide the time, manner, and form for making the registry public. (5) Recognized accreditation bodies may accredit labs operating outside the U.S., as long as those labs meet the same standards as accredited domestic labs. (6) The Secretary must develop model standards a lab must meet to be accredited for a specific testing method and listed in the registry, consulting existing standards for guidance. These model standards must include: (A) methods ensuring proper sampling and analytical procedures are followed, results are certified as true and accurate, internal quality systems exist, complaints are handled promptly, and testing staff are qualified by training and experience; and (B) any other criteria the Secretary decides are appropriate. (7) The Secretary must re-evaluate each recognized accreditation body at least once every 5 years, may accompany its auditors to assess compliance, and must promptly revoke recognition from any body found not to comply — specifying any conditions its accredited labs need to keep testing. (b) Testing procedures: (1) Within 30 months of January 4, 2011, certain food testing must be done only by federal labs or by non-federal labs accredited on the Secretary's registry for the right testing method, when the testing is: (A) done by or for a food's owner or consignee to meet a specific legal testing requirement addressing a known or suspected food safety problem, or as the Secretary otherwise requires for such a problem; or (B) done for an owner or consignee to support admitting a food shipment under section 381(a), or under an Import Alert requiring successive successful tests. (2) Test results must go directly to the FDA, though the Secretary may exempt some results by regulation if they don't help protect public health; required results may be submitted electronically. (3) The Secretary may waive these requirements if a new testing method has been developed and validated but no lab is yet accredited for it, and using that method is necessary to prevent, control, or handle a food emergency or foodborne illness outbreak. (c) Review by Secretary: If food sampling and testing by an accredited state or local lab leads a state to recall a food, the Secretary must review that sampling and testing to decide whether a national recall or other enforcement action is needed. (d) No limit on Secretarial authority: Nothing in this section limits the Secretary's ability to review and act on information from food testing, including deciding whether that information and testing are sufficient.

the actual law source: uscode.house.gov ↗public domain

(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 1 (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.

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.

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

history & why it existsrecord from the source credit

1938Enacted · Pub. L. 111-353 · 124 Stat. 3926

A history note hasn’t been published yet. The record shows enactment by Pub. L. 111-353 on 1938-06-25.

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