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7 USC CHAPTER 6A - NATIONAL LABORATORY ACCREDITATION 01/06/03

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TITLE 7 - AGRICULTURE

CHAPTER 6A - NATIONAL LABORATORY ACCREDITATION

.

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CHAPTER 6A - NATIONAL LABORATORY ACCREDITATION

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Sec.

138. Definitions.

138a. National Laboratory Accreditation Program.

(a) Establishment of Program.

(b) Standards.

(c) Accrediting bodies.

(d) Requirements.

(e) Exceptions.

138b. Accreditation.

(a) In general.

(b) Requirements for accreditation.

(c) Failure to meet accreditation standards.

(d) Limited accreditation.

138c. Samples.

(a) Performance evaluation samples.

(b) Results of testing.

(c) Review of accreditation.

138d. Application.

(a) Contents of application.

(b) Restrictions on submission of application.

138e. Reporting.

(a) In general.

(b) Timing of report.

(c) Guidelines.

138f. Fees.

(a) In general.

(b) Amount of fee.

(c) Reimbursement of expenses.

(d) Adjustment of fees.

(e) Appropriations prerequisite.

(f) Authorization of appropriations.

138g. Public disclosure.

138h. Regulations.

138i. Effect of other laws.

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7 USC Sec. 138 01/06/03

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Sec. 138. Definitions

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As used in this chapter:

(1) Agricultural product

The term ''agricultural product'' means any fresh fruit or

vegetable or any commodity or product derived from livestock or

fowl, that is marketed in the United States for human

consumption.

(2) Certificate

The term ''certificate'' means a certificate of accreditation

issued under this chapter.

(3) Laboratory

The term ''laboratory'' means any facility or vehicle that is

owned by an individual or a public or private entity and is

equipped and operated for the purpose of carrying out pesticide

residue analysis on agricultural products for commercial

purposes.

(4) Pesticide

The term ''pesticide'' means any substance that alone, in

chemical combination, or in any formulation with one or more

substances, is defined as a pesticide in section 136(u) of this

title.

(5) Secretary

The term ''Secretary'' means the Secretary of Agriculture.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1321, Nov. 28, 1990, 104 Stat.

3562.)

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7 USC Sec. 138a 01/06/03

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TITLE 7 - AGRICULTURE

CHAPTER 6A - NATIONAL LABORATORY ACCREDITATION

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Sec. 138a. National Laboratory Accreditation Program

-STATUTE-

(a) Establishment of Program

The Secretary shall administer a National Laboratory

Accreditation Program under which laboratories that request

accreditation and conduct residue testing of agricultural products,

or that make claims to the public or buyers of agricultural

products concerning chemical residue levels on agricultural

products, shall be determined to meet certain minimum quality and

reliability standards.

(b) Standards

The Secretary of Health and Human Services, after consultation

with the Secretary and the Administrator of the Environmental

Protection Agency, shall establish, through regulations, standards

for the National Laboratory Accreditation program (FOOTNOTE 1) that

shall include -

(FOOTNOTE 1) So in original. Probably should be capitalized.

(1) standards applicable to laboratories;

(2) qualifications for directors and other personnel; and

(3) standards and procedures for quality assurance programs.

(c) Accrediting bodies

The Secretary of Health and Human Services shall approve State

agencies or private, nonprofit entities as accrediting bodies to

act on behalf of such Secretary in implementing the certification

and quality assurance programs in accordance with the requirements

of this section. In making such approvals the Secretary of Health

and Human Services shall -

(1) oversee and review the performance of any accrediting body

acting on behalf of the Secretary to ensure that such accrediting

body is in compliance with the requirements of the certification

program under this section; and

(2) have the right to obtain from an accrediting body acting on

behalf of the Secretary and from any laboratory that may be

certified by such a body all records and materials that may be

necessary for the oversight and review required by paragraph (1).

(d) Requirements

To be accredited under this chapter, a laboratory shall -

(1) prepare and submit an application for accreditation to the

Secretary; and

(2) comply with such terms and conditions as are determined

necessary by the Secretary and the Secretary of Health and Human

Services.

(e) Exceptions

This chapter shall not apply to -

(1) a laboratory operated by a government agency;

(2) a laboratory operated by a corporation that only performs

analysis of residues on agricultural products for such

corporation or any wholly owned subsidiary of such corporation

and does not make claims to the public or buyers based on such

analysis;

(3) a laboratory operated by a partnership that only performs

analysis of residues on agricultural products for the partners of

such partnership and does not make claims to the public or buyers

based on such analysis; or

(4) a laboratory not operated for commercial purposes that

performs pesticide chemical residue analysis on agricultural

products for research or quality control for the internal use of

a person who is initiating the analysis.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1322, Nov. 28, 1990, 104 Stat.

3562.)

-SECREF-

SECTION REFERRED TO IN OTHER SECTIONS

This section is referred to in sections 138b, 138c of this title.

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7 USC Sec. 138b 01/06/03

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Sec. 138b. Accreditation

-STATUTE-

(a) In general

The Secretary shall issue certificates of accreditation to

laboratories that meet the requirements of this chapter, as

determined by the Secretary.

(b) Requirements for accreditation

To receive accreditation under this chapter, a laboratory shall

prepare and submit an application for accreditation to the

Secretary and shall complete such required tests, and meet such

standards as established under section 138a of this title.

(c) Failure to meet accreditation standards

The Secretary shall deny an application for accreditation or

shall revoke any existing accreditation with respect to any

laboratory that fails to meet the requirements for accreditation

under this chapter.

(d) Limited accreditation

The Secretary may issue certificates of accreditation to

laboratories that are limited to specific fields of testing.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1323, Nov. 28, 1990, 104 Stat.

3563.)

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7 USC Sec. 138c 01/06/03

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Sec. 138c. Samples

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(a) Performance evaluation samples

(1) Provided by Secretary

The Secretary shall ensure that performance evaluation samples

are provided to any laboratory that has applied for accreditation

under this chapter.

(2) Analysis by laboratory

A laboratory described in paragraph (1) shall analyze such

performance evaluation samples and submit the results of such

analysis to the Secretary, as provided for in section 138a of

this title.

(3) Testing methods

Samples shall be tested by the laboratory according to methods

specifically approved for such purpose by alternate methods of

demonstrated adequacy or equivalence, as determined in

regulations established under this chapter.

(b) Results of testing

(1) Submission of results

The laboratory shall submit the results of the tests conducted

under subsection (a) of this section to the Secretary on forms

provided by the Secretary, on or before the date determined by

the Secretary.

(2) Evaluation of tests

The Secretary shall evaluate the results of such tests achieved

by the laboratory and shall determine whether such laboratory is

capable of undertaking an accurate analysis of chemical residues

in agricultural products.

(c) Review of accreditation

The Secretary shall ensure that performance evaluation samples

for analysis are provided to laboratories accredited under this

chapter not less than two times a year.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1324, Nov. 28, 1990, 104 Stat.

3564.)

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7 USC Sec. 138d 01/06/03

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Sec. 138d. Application

-STATUTE-

(a) Contents of application

An application for accreditation under this chapter shall be

prepared and submitted to the Secretary and shall include -

(1) the name and address of the laboratory;

(2) the name and address of the owners and managers of such

laboratory;

(3) a statement concerning the type of analysis the laboratory

intends to conduct;

(4) a brief history of the laboratory and its previous

operations; and

(5) such other information as may be required by the Secretary.

(b) Restrictions on submission of application

A laboratory that has been denied, or has lost, accreditation

under this chapter shall not reapply for accreditation until the

expiration of at least 6 months after such denial or loss of

accreditation. Corrective actions taken by the laboratory to

address deficiencies upon which the denial or loss of accreditation

was based must accompany the reapplication.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1325, Nov. 28, 1990, 104 Stat.

3564.)

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7 USC Sec. 138e 01/06/03

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Sec. 138e. Reporting

-STATUTE-

(a) In general

Each laboratory or individual that performs, brokers, or

otherwise arranges for the performance of a pesticide chemical

analysis of food shall prepare and submit a report, simultaneously

to the Secretary, the Secretary of Health and Human Services, and

to the owner of such food, that shall contain any finding of

pesticide chemical residues in such food -

(1) for which no chemical residue tolerance or exemption has

been established;

(2) that is in excess of residue tolerances; or

(3) for which the chemical residue tolerance has been revoked

or the chemical residue is otherwise not permitted by the

Environmental Protection Agency.

(b) Timing of report

A laboratory shall submit the report required under subsection

(a) of this section to the Secretary, the Secretary of Health and

Human Services, and the owner of such food as soon as practicable

after the completion of the analysis of such food.

(c) Guidelines

The Secretary shall adopt standardized reporting guidelines to be

applied to laboratories under this section and shall provide such

guidelines to laboratories accredited under this chapter, as well

as other sources of information regarding applicable pesticide

chemical tolerances.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1326, Nov. 28, 1990, 104 Stat.

3565.)

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7 USC Sec. 138f 01/06/03

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Sec. 138f. Fees

-STATUTE-

(a) In general

At the time that an application for accreditation is received by

the Secretary and annually thereafter, a laboratory seeking

accreditation by the Secretary under the authority of this chapter,

the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), or the

Poultry Products Inspection Act (21 U.S.C. 451 et seq.) shall pay

to the Secretary a nonrefundable accreditation fee. All fees

collected by the Secretary shall be credited to the account from

which the expenses of the laboratory accreditation program are paid

and, subject to subsection (e) of this section, shall be available

immediately and remain available until expended to pay the expenses

of the laboratory accreditation program.

(b) Amount of fee

The fee required under this section shall be established by the

Secretary in an amount that will offset the cost of the laboratory

accreditation programs administered by the Secretary under the

statutory authorities set forth in subsection (a) of this section.

(c) Reimbursement of expenses

Each laboratory that is accredited under a statutory authority

set forth in subsection (a) of this section or that has applied for

accreditation under such authority shall reimburse the Secretary

for reasonable travel and other expenses necessary to perform

onsite inspections of the laboratory.

(d) Adjustment of fees

The Secretary may, on an annual basis, adjust the fees imposed

under this section as necessary to support the full costs of the

laboratory accreditation programs carried out under the statutory

authorities set forth in subsection (a) of this section.

(e) Appropriations prerequisite

No fees collected under this section may be used to offset the

cost of laboratory accreditation without appropriations made under

subsection (f) of this section.

(f) Authorization of appropriations

There are authorized to be appropriated each fiscal year such

sums as may be necessary for laboratory accreditation services

under this section.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1327, Nov. 28, 1990, 104 Stat.

3565; Pub. L. 102-237, title X, Sec. 1017, Dec. 13, 1991, 105 Stat.

1904.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Meat Inspection Act, referred to in subsec. (a), is

titles I to IV of act Mar. 4, 1907, ch. 2907, as added Dec. 15,

1967, Pub. L. 90-201, 81 Stat. 584, and amended, which are

classified generally to subchapters I to IV (Sec. 601 et seq.) of

chapter 12 of Title 21, Food and Drugs. For complete classification

of this Act to the Code, see Short Title note set out under section

601 of Title 21 and Tables.

The Poultry Products Inspection Act, referred to in subsec. (a),

is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended, which

is classified generally to chapter 10 (Sec. 451 et seq.) of Title

21. For complete classification of this Act to the Code, see Short

Title note set out under section 451 of Title 21 and Tables.

-MISC2-

AMENDMENTS

1991 - Pub. L. 102-237 amended section generally, in subsec. (a),

inserting provisions relating to Federal Meat Inspection Act and

Poultry Products Inspection Act and provisions relating to

crediting and availability of fees, in subsec. (b), substituting

provisions relating to fee under this section for provisions

relating to fee under subsec. (a) of this section, and provisions

relating to laboratory accreditation programs administered by

Secretary under statutory authorities set forth in subsec. (a) of

this section for provisions relating to program established under

this chapter, in subsec. (c), substituting provisions relating to

statutory authority set forth in subsec. (a) of this section for

provisions relating to this chapter, in subsec. (d), substituting

provisions relating to laboratory accreditation programs under

statutory authority set forth in subsec. (a) of this section for

provisions relating to program established under this chapter, and

adding subsecs. (e) and (f).

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7 USC Sec. 138g 01/06/03

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Sec. 138g. Public disclosure

-STATUTE-

The results of the evaluations of laboratories conducted by the

Secretary under this chapter shall be made available to the

Secretary of Health and Human Services and to the public on

request.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1328, Nov. 28, 1990, 104 Stat.

3565.)

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7 USC Sec. 138h 01/06/03

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Sec. 138h. Regulations

-STATUTE-

The Secretary shall promulgate regulations to carry out this

chapter.

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1329, Nov. 28, 1990, 104 Stat.

3565.)

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7 USC Sec. 138i 01/06/03

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Sec. 138i. Effect of other laws

-STATUTE-

Nothing in this chapter shall alter the authority of the

Secretary of Health and Human Services under the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

-SOURCE-

(Pub. L. 101-624, title XIII, Sec. 1330, Nov. 28, 1990, 104 Stat.

3565.)

-REFTEXT-

REFERENCES IN TEXT

The Federal Food, Drug, and Cosmetic Act, referred to in text, is

act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is

classified generally to chapter 9 (Sec. 301 et seq.) of Title 21,

Food and Drugs. For complete classification of this Act to the

Code, see section 301 of Title 21 and Tables.

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