Section

[Code of Federal Regulations]

[Title 9, Volume 2]

[Revised as of January 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 9CFR318.21]

[Page 263-277]

TITLE 9--ANIMALS AND ANIMAL PRODUCTS

CHAPTER III--FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF

AGRICULTURE

PART 318_ENTRY INTO OFFICIAL ESTABLISHMENTS; REINSPECTION AND PREPARATION

OF PRODUCTS--Table of Contents

Subpart A_General

Sec. 318.21 Accreditation of chemistry laboratories.

(a) Definitions--Accredited laboratory-- A non-Federal analytical

laboratory that has met the requirements for accreditation specified in

this section and hence, at an establishment's discretion, may be used in

lieu of an FSIS laboratory for analyzing official regulatory samples.

Payment for the analysis of official samples is to be made by the

establishment using the accredited laboratory.

Accreditation--Determination by FSIS that a laboratory is qualified

to analyze official samples of product subject to regulations in this

subchapter and part 381 of this chapter for the presence and amount of

all four food chemistry analytes (protein, moisture, fat, and salt); or

a determination by FSIS that a laboratory is qualified to analyze

official samples of product subject to regulations in this subchapter

and part 381 of this chapter for the presence and amount of one of

several classes of chemical residue, in accordance with the requirements

of the Accredited Laboratory Program. Accreditations are granted

separately for the food chemistry analysis of official samples and for

the analysis of such samples for any one of the several classes of

chemical residue. A laboratory may hold more than one accreditation.

AOAC methods--Methods of chemical analysis, Chapter 39, Association

of Official Analytical Chemists (AOAC), published in the ``Official

Methods of Analysis of the Association of Official Analytical

Chemists,'' 15th edition, 1990.\1\ The ``Official Methods of Analysis of

the Association of Official Analytical Chemists,'' 15th edition, 1990,

is incorporated by reference with the approval of the Director of the

Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.

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\1\ A copy of the ``Official Methods of Analysis of the Association

of Official Analytical Chemists,'' 15th edition, 1990, is on file with

the Director, Office of the Federal Register, and may be purchased from

the Association of Official Analytical Chemists, Inc., 2200 Wilson

Boulevard, Suite 400, Arlington, Virginia 22201.

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Chemical residue misidentification-- see ``correct chemical residue

identification'' definition.

[[Page 264]]

Coefficient of variation (CV)-- The standard deviation of a

distribution of analytical values multiplied by 100, and divided by the

mean of those values.

Comparison Mean--The average, for a sample, of all accredited and

FSIS laboratories' average results, each of which has a large deviation

measure of zero, except when only two laboratories perform the analysis,

as in the case of split sample analysis by both an accredited laboratory

and an FSIS laboratory. In the latter case, the comparison mean is the

average of the two laboratories' results. For food chemistry, a result

for a laboratory is the obtained analytical value; for chemical

residues, a result is the logarithmic transformation of the obtained

analytical value.

Correct chemical residue identification--Correct identification by a

laboratory of a chemical residue whose concentration, in a sample, is

equal to or greater than the minimum reporting level for that residue,

as determined by the median of all positive analytical values obtained

by laboratories analyzing the sample. Failure of a laboratory to report

the presence such a chemical residue is considered a mis ident i fi

cation. In addition, reporting the presence of a residue at a level

equal to or above the minimum reporting level that is not reported by 90

percent or more of all other laboratories analyzing the sample, is

considered a misidentification.

CUSUM--A class of statistical procedures for assessing whether or

not a process is ``in control''. Each CUSUM value is constructed by

accumulating incremental values obtained from observed results of the

process, and then determined to either exceed or fall within acceptable

limits for that process. The initial CUSUM values for each laboratory

whose application for accreditation is accepted are set at zero. The

four CUSUM procedures are:

(1) Positive systemic laboratory difference CUSUM (CUSUM-P)--

monitors how consistently an accredited laboratory gets numerically

greater results than the comparison mean;

(2) Negative systematic laboratory difference CUSUM (CUSUM-N)--

monitors how consistently an accredited laboratory gets numerically

smaller results than the comparison mean;

(3) Variability CUSUM (CUSUM-V)--monitors the average ``total

discrepancy'' (i.e., the combination of the random fluctuations and

systematic differences) between an accredited laboratory's results and

the comparison mean;

(4) Individual large discrepancy CUSUM (CUSUM-D)--monitors the

magnitude and frequency of large differences between the results of an

accredited laboratory and the comparison mean.

Individual large deviation--An analytical result from a non-Federal

laboratory that differs from the sample comparison mean by more than

would be expected assuming normal laboratory variability.

Initial accreditation check sample--A sample prepared and sent by an

FSIS laboratory to a non-Federal laboratory to ascertain if the non-

Federal laboratory's analytical capability meets the standards for

granting accreditation.

Interlaboratory accreditation maintenance check sample--A sample

prepared and sent by FSIS to a non-Federal laboratory to assist in

determining if acceptable levels of analytical capability are being

maintained by the accredited laboratory.

Large deviation measure--A measure that quantifies an unacceptably

large difference between a non-Federal laboratory's analytical result

and the sample comparison mean.

Minimum proficiency level--The minimum concentration of a residue at

which an analytical result will be used to assess a laboratory's

quantification capability. This concentration is an estimate of the

smallest concentration for which the average coefficient of variation

(CV) for reproducibility (i.e., combined within and between laboratory

variability) does not exceed 20 percent. (See Table 2)

Minimum reporting level--The number such that if any obtained

analytical value equals or exceeds this number, then the residue is

reported together with the obtained analytical value.

Official Sample--A sample selected by a Program employee in

accordance with FSIS procedures for regulatory use.

[[Page 265]]

Probation-- The period commencing with official notification to an

accredited laboratory that its check or split sample results no longer

satisfy the performance requirements specified in this rule, and ending

with official notification that accreditation is either fully restored,

suspended, or revoked.

QA (quality assurance) recovery--The ratio of a laboratory's

unadjusted analytical value of a check sample residue to the residue

level fortified by the FSIS laboratory that prepared the sample,

multiplied by 100. (See Table 2.)

QC (quality control) recovery--The ratio of a laboratory's

unadjusted analytical value of a quality control standard to the

fortification level of the standard, multiplied by 100. (See Table 2.)

Refusal of Accreditation--An action taken when a laboratory which is

applying for accreditation is denied the accreditation.

Responsibly connected--Any individual who or entity which is a

partner, officer, director, manager, or owner of 10 per centum or more

of the voting stock of the applicant or recipient of accreditation or an

employee in a managerial or executive capacity or any employee who

conducts or supervises the chemical analysis of FSIS official samples.

Revocation of Accreditation--An action taken against a laboratory

which removes its right to analyze official samples.

Split sample-- An official sample divided into duplicate portions,

one portion to be analyzed by an accredited laboratory (for official

regulatory purposes) and the other portion by an FSIS laboratory (for

comparison purposes).

Standardizing Constant--The number which is the result of a

mathematical adjustment to the ``standardized value.'' Specifically, the

number equals the square root of the expected variance of the difference

between the accredited or applying laboratory's result and the

comparison mean on a sample, taking into consideration the standardizing

value, the correlation and number of repeated results by a laboratory on

a sample, and the number of laboratories that analyzed the sample.

Standardized Difference--The quotient of the difference between a

laboratory's result on a sample and the comparison mean of the sample

divided by the standardizing constant.

Standardizing Value--A number representing the performance standard

deviation of an individual result (see Tables 1 and 2 and footnotes to

the Tables for determining exact procedures for calculation).

Suspension of Accreditation--Action taken against a laboratory which

temporarily removes its right to analyze official samples. Suspension of

accreditation ends when accreditation is either fully restored or

revoked.

Systematic laboratory difference--A comparison of one laboratory's

results with the comparison means on samples that shows, on average, a

consistent relationship. A laboratory that is reporting, on average,

numerically greater results than the comparison mean has a positive

systematic laboratory difference and, conversely, numerically smaller

results indicate a negative systematic laboratory difference.

Variability-- Random fluctuations in a laboratory's processes that

cause its analytical results to deviate from a true value.

Variance--The expected average of the squared differences of sample

results from an expected sample mean.

Table 1--Standardizing Values for Food Chemistry

[By product class and analyte]

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Protein

Product/Class Moisture \1\ Fat \2\ Salt \3\

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Cured Pork/Canned Ham............................................ 0.50 0.060 0.26 (0.30) 0.127

Ground Beef...................................................... 0.71 0.060 (0.35) 0.127

Other............................................................ 0.57 0.060 0.26 (0.30) 0.127

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\1\ To obtain the standardizing value for a sample the appropriate entry in this column is multiplied by X0.65

where X is the comparison mean of the sample.

\2\ To obtain the standardizing value for a sample, the appropriate entry in this column is multiplied by X0.25,

where X is the comparison mean of the sample. The appropriate entry is equal to the value in parentheses when

X is equal to or greater than 12.5 percent, otherwise it is equal to 0.26.

\3\ To obtain the standardizing value for a sample, when the comparison mean of the sample, X, is less than 1.0

percent, the standardizing value equals 0.127, otherwise the appropriate entry is multiplied by X0.25. When X

is equal to or greater than 4.0 percent for dry salami and pepperoni products, the standardizing value equals

0.22.

[[Page 266]]

Table 2--Minimum Proficiency Levels, Percent Expected Recoveries (QC and QA), and Standardizing Values for

Chemical Residues

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Percent expected

Class of residues Minimum recovery (QC and Standardizing

proficiency level QA) value \3\

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Chlorinated Hydrocarbons:\1\

Aldrin............................................. 0.10 ppm 80-110 0.20

Benzene Hexachloride............................... 0.10 ppm 80-110 0.20

Chlordane.......................................... 0.30 ppm 80-110 0.20

Dieldrin........................................... 0.10 ppm 80-110 0.20

DDT................................................ 0.15 ppm 80-110 0.20

DDE................................................ 0.10 ppm 80-110 0.20

TDE................................................ 0.15 ppm 80-110 0.20

Endrin............................................. 0.10 ppm 80-110 0.20

Heptachlor......................................... 0.10 ppm 80-110 0.20

Heptachlor Epoxide................................. 0.10 ppm 80-110 0.20

Lindane............................................ 0.10 ppm 80-110 0.20

Methoxychlor....................................... 0.50 ppm 80-110 0.20

Toxaphene.......................................... 1.00 ppm 80-110 0.20

Hexachlorobenzene.................................. 0.10 ppm 80-110 0.20

Mirex.............................................. 0.10 ppm 80-110 0.20

Nonachlor.......................................... 0.15 ppm 80-110 0.20

Polychlorinated Biphenyls: 0.50 ppm 80-110 0.20

Arsenic \2\........................................ 0.20 ppm 90-105 0.25

Sulfonamides \2\................................... 0.08 ppm 70-120 0.25

Volatile Nitrosamine \2\........................... 5 ppm 70-110 0.25

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\1\ Laboratory statistics are computed over all results (excluding PCB results), and for specific chemical

residues.

\2\ Laboratory statistics are only computed for specific chemical residues.

\3\ The standardizing value of all initial accreditation and probationary check samples computations is 0.15.

(b) Laboratories accredited for analysis of protein, moisture, fat,

and salt content of meat and meat products--(1) Applying for

accreditation. Application for accreditation shall be made on designated

forms provided by FSIS, or otherwise in writing, by the owner or manager

of a non-Federal analytical laboratory and sent to the Accredited

Laboratory Program, Food Safety and Inspection Service, U.S. Department

of Agriculture, Washington, DC 20250-3700, and shall specify the kinds

of accreditation that are wanted by the owner or manager of the

laboratory. A laboratory whose accreditation has been refused or revoked

may reapply for accreditation after 60 days from the effective date of

that action, and must provide written documentation specifying what

corrections were made.

(i) At the time that an Application for Accreditation is filed with

the Accredited Laboratory Program, FSIS, and annually thereafter upon

receipt of the bill issued by FSIS on the anniversary date of each

accreditation, the management of a laboratory shall reimburse the

program at the rate specified in 9 CFR 391.5 for the cost of each

accreditation that is sought for the laboratory or that the laboratory

holds.

(ii) Simultaneously with the initial application for accreditation,

the management of a laboratory shall forward a check, bank draft, or

money order in the amount specified in 9 CFR 391.5 made payable to the

U.S. Department of Agriculture along with the completed application for

the accreditation(s) sought by the laboratory. Accreditation will not be

granted or continued, without further procedure, for failure to pay the

accreditation fee(s). The fee(s) paid shall be nonrefundable and shall

be credited to the account from which the expenses of the laboratory

accreditation program are paid.

(iii) Annually on the anniversary date of each accreditation, FSIS

will issue a bill in the amount specified in 9 CFR 391.5.

(iv) Bills are payable upon receipt by check, bank draft, or money

order, made payable to the U.S. Department of Agriculture, and become

delinquent 30 days from the date of the bill. Accreditation will be

terminated without further procedure for having a delinquent account.

The fee(s) paid shall be nonrefundable and shall be credited to the

account from which the expenses of

[[Page 267]]

the Accredited Laboratory Program are paid.

(v) The accreditation of a laboratory that was accredited by FSIS on

or before December 13, 1993 and was not on probation and whose

accreditation on that date was not in suspension or revocation shall be

continued, provided that such laboratory reapply for accreditation in

accordance with the provisions of this paragraph (b)(1) by January 12,

1994 (30 days after the effective date of this section), and that the

reapplication be accepted by the Agency. The CUSUM values for such

laboratory will be reset at zero upon acceptance of its reapplication.

The accreditation of a laboratory that is on probation shall be

continued, provided that the laboratory reapply for accreditation by

February 11, 1994 (60 days after the effective date of this section),

that the reapplication be accepted by the Agency, and that the

laboratory satisfy the terms of the probation.

(2) Criteria for obtaining accreditation. Non-Federal analytical

laboratories may be accredited for the analyses of moisture, protein,

fat, and salt content of meat and meat food products. Accreditation will

be given only if the applying laboratory successfully satisfies the

requirements presented below, for all four analytes. This accreditation

authorizes official FSIS acceptance of the analytical test results

provided by these laboratories on official samples. To obtain FSIS

accreditation for moisture, protein, fat, and salt analyses, a non-

Federal analytical laboratory must:

(i) Be supervised by a person holding, as a minimum, a bachelor's

degree in either chemistry, food science, food technology, or a related

field and having 1 year's experience in food chemistry, or equivalent

qualifications, as determined by the Administrator.

(ii) Demonstrate acceptable levels of systematic laboratory

difference, variability, and individual large deviations in the analyses

of moisture, protein, fat, and salt content using AOC methods. An

applying laboratory will successfully demonstrate these capabilities if

its moisture, protein, fat, and salt results from a 36 check sample

accreditation study each satisfy the criteria presented below.\2\ If the

laboratory's analysis of an analyte (or analytes) from the first set of

36 check samples does not meet the criteria for obtaining accreditation,

a second set of 36 check samples will be provided within 30 days

following the date of receipt by FSIS of a request from the applying

laboratory. The second set of samples shall be analyzed for only the

analyte(s) for which unacceptable initial results had been obtained by

the laboratory. If the results of the second set of samples do not meet

the accreditation criteria, the laboratory may reapply after a 60-day

waiting period, commencing from the date of refusal of accreditation by

FSIS. At that time, a new application, all fees, and all documentation

of corrective action required for accreditation must be submitted.

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\2\ All statistical computations are rounded to the nearest tenth,

except where otherwise noted.

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(A) Systematic laboratory difference: The absolute value of the

average standardized difference must not exceed 0.73 minus the product

of 0.17 and the standard deviation of the standardized differences.

(B) Variability: The estimated standard deviation of the

standardized differences must not exceed 1.15.

the large deviation measures of the individual samples must be less than

5.0.\3\

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\3\ A result will have a large deviation measure equal to zero when

the absolute value of the result's standardized difference, (d), is less

than 2.5, and otherwise a measure equal to 1-(2.5/d)\4\.

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(iii) Allow inspection of the laboratory by FSIS officials prior to

the determination of granting accredited status.

(iv) Pay the accreditation fee by the date required.

(3) Criteria for maintaining accreditation. To maintain

accreditation for moisture, protein, fat, and salt analyses, a non-

Federal analytical laboratory must:

(i) Report analytical results of the moisture, protein, fat, and

salt content of official samples, weekly, on designated forms to the

FSIS Eastern Laboratory, College Station Road, P.O.

[[Page 268]]

Box 6085, Athens, GA 30604, or to the address designated by the

Assistant Administrator, Office of Public Health and Science.

(ii) Maintain laboratory quality control records for the most recent

3 years that samples have been analyzed under this Program.

(iii) Maintain complete records of the receipt, analysis, and

disposition of official samples for the most recent 3 years that samples

have been analyzed under this Program.

(iv) Maintain a standards book, which is a permanently bound book

with sequentially numbered pages, containing all readings and

calculations for standardization of solutions, determination of

recoveries, and calibration of instruments. All entries are to be dated

and signed by the analyst immediately upon completion of the entry and

by his/her supervisor within 2 working days. The standards book is to be

retained for a period of 3 years after the last entry is made.

(v) Analyze interlaboratory accreditation maintenance check samples

and return the results to FSIS within 3 weeks of sample receipt. This

must be done whenever requested by FSIS and at no cost to FSIS.

(vi) Inform the Accredited Laboratory Program, Food Safety and

Inspection Service, U.S. Department of Agriculture, Washington, DC

20250-3700, by certified or registered mail, within 30 days, when there

is any change in the laboratory's ownership, officers, directors,

supervisory personnel, or other responsibly connected individual or

entity.

(vii) Permit any duly authorized representative of the Secretary to

perform both announced and unannounced on-site laboratory reviews of

facilities and records during normal business hours, and to copy any

records pertaining to the laboratory's participation in the Accredited

Laboratory Program.

(viii) Use official AOAC methods \4\ on official and check samples.

The ``Official Methods of Analysis of the Association of Official

Analytical Chemists,'' 15th edition, 1990, is incorporated by reference

with the approval of the Director of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

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\4\ A copy of the ``Official Methods of Analysis of the Association

of Analytical Chemists,'' 15th edition, 1990, is on file with the

Director, Office of the Federal Register, and may be purchased from the

Association of Official Analytical Chemists, Inc., 2200 Wilson

Boulevard, Suite 400, Arlington, Virginia 22201.

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(ix) Demonstrate that acceptable limits of systematic laboratory

difference, variability, and individual large deviations are being

maintained in the analyses of moisture, protein, fat, and salt content.

An accredited laboratory will successfully demonstrate the maintenance

of these capabilities if its moisture, protein, fat, and salt results

from interlaboratory accreditation maintenance check samples and/or

split samples satisfy the criteria presented below.\5\

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\5\ All statistical computations are rounded to the nearest tenth,

except where otherwise noted.

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(A) Systematic laboratory difference:

(1) Positive systematic laboratory difference: The standardized

difference between the accredited laboratory's result and that of the

FSIS laboratory for each split or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as CUSUM-P. This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM

increment is set equal to:

2.0, if the standardized difference is greater than 1.6,

-2.0, if the standardized difference is less than -1.6,

the standardized difference minus 0.4, if the standardized difference

lies between -1.6 and 2.4, inclusive.

(ii) Compute the new CUSUM-P value. The new CUSUM-P value is

obtained by adding algebraically, the CUSUM increment to the last

previously computed CUSUM-P value. If this computation yields a value

smaller than 0, the new COSUM-P value is set equal to 0. [COSUM-P values

are initialized at zero; that is, the COSUM-P value associated with the

first sample is set equal to the CUSUM increment for that sample.]

[[Page 269]]

(iii) Evaluate the new COSUM-P value. The new COSUM-P value must not

exceed 5.2.

(2) Negative systematic laboratory difference: The standardized

difference between the accredited laboratory's result and that of the

FSIS laboratory for each split or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as COSUM-N. This value is computed and evaluated as follows:

(i) Determine the CUSUM increment for the sample. The CUSUM

increment is set equal to:

2.0, if the standardized difference is greater than 1.6,

-2.0, if the standardized difference is less than -2.4,

the standardized difference plus 0.4, if the standardized difference

lies between -2.4 and 1.6, inclusive.

(ii) Compute the new COSUM-N value. The new COSUM-N value is

obtained by subtracting, algebraically, the CUSUM increment to the last

previously computed COSUM-N value. If this computation yields a value

smaller than 0, the new COSUM-N value is set equal to 0. [COSUM-N values

are initialized at zero; that is, the COSUM-N value associated with the

first sample is set equal to the CUSUM increment for that sample.]

(iii) Evaluate the new COSUM-N value. The new COSUM-N value must not

exceed 5.2.

(B) Variability: The absolute value of the standardized difference

between the accredited laboratory's result and that of the FSIS

laboratory for each split sample or interlaboratory accreditation

maintenance check sample is used to determine a CUSUM value, designated

as COSUM-V. This value is computed and evaluated as follows:

(1) Determine the CUSUM increment for the sample. The CUSUM

increment is set equal to the larger of -0.4 and the absolute value of

the standardized difference minus 0.9. If this computation yields a

value larger than 1.6, the increment is set equal to 1.6.

(2) Compute the new COSUM-V value. The new COSUM-V value is obtained

by adding, algebraically, the CUSUM increment to the last previously

computed COSUM-V value. If this computation yields a value less than 0,

the new COSUM-V value is set equal to 0. [COSUM-V values are initialized

at zero; that is, the COSUM-V value associated with the first sample is

set equal to the CUSUM increment for that sample.]

(3) Evaluate the new COSUM-V value. The new COSUM-V value must not

exceed 4.3.

laboratory's result for each split sample or interlaboratory

accreditation maintenance check sample is used to determine a CUSUM

value, designated as COSUM-D.\6\ This value is computed and evaluated as

follows:

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\6\ See footnote 3.

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(1) Determine the CUSUM increment for the sample. The CUSUM

increment is set equal to the value of the large deviation measure minus

0.025.

(2) Compute the new COSUM-D value. The new COSUM-D value is obtained

by adding, algebraically, the CUSUM increment to the last previously

computed COSUM-D value. If this computation yields a value less that 0,

the new COSUM-D value is set equal to 0. [COSUM-D values are initialized

at zero; that is, the COSUM-D value associated with the first sample is

set equal to the CUSUM increment for that sample.]

(3) Evaluate the new COSUM-D value. The new COSUM-D value must not

exceed 1.0.

(x) Meet the following requirements if placed on probation pursuant

to paragraph (e) of this section:

(A) Send all official samples that have not been analyzed as of the

date of written notification of probation to a specified FSIS laboratory

by certified mail or private carrier or, as an alternative, to an

accredited laboratory approved for food chemistry. Mailing expenses will

be paid by FSIS.

(B) Analyze a set of check samples similar to those used for initial

accreditation, and submit the analytical results to FSIS within 3 weeks

of receipt of the samples.

(b)(2)(ii) (A), (B), and (C) of this section.

[[Page 270]]

(xi) Expeditiously report analytical results of official samples to

the FSIS Eastern Laboratory, College Station Road, P.O. Box 6085,

Athens, GA 30604, or to the address designated by the Assistant

Administrator, Office of Public Health and Science. The Federal

inspector at any establishment may assign the analysis of official

samples to an FSIS laboratory if, in the inspector's judgment, there are

delays in receiving test results on official samples from an accredited

laboratory.

(xii) Pay the required accreditation fee when it is due.

residues in meat and meat food products--(1) Applying for accreditation.

Application for accreditation shall be made on designated forms provided

by FSIS, or otherwise in writing, by the owner or manager of the non-

Federal analytical laboratory and sent to the Accredited Laboratory

Program, Food Safety and Inspection Service, U.S. Department of

Agriculture, Washington, DC 20250-3700, and shall specify the kinds of

accreditation that are wanted by the owner or manager of the laboratory.

A laboratory whose accreditation has been refused or revoked may reapply

for accreditation after 60 days from the effective date of that action,

and must provide written documentation specifying what corrections were

made.

(i) At the time that an Application for Accreditation is filed with

the Accredited Laboratory Program, FSIS, and annually thereafter upon

receipt of the bill issued by FSIS on the anniversary date of each

accreditation, the management of a laboratory shall reimburse the

program at the rate specified in 9 CFR 391.5 for the cost of each

accreditation that is sought for the laboratory or that the laboratory

holds.

(ii) Simultaneously with the initial application for accreditation,

the management of a laboratory shall forward a check, bank draft, or

money order in the amount specified in 9 CFR 391.5 made payable to the

U.S. Department of Agriculture along with the completed application for

the accreditation(s) sought for the laboratory. Accreditation will not

be granted or continued, without further procedure, for failure to pay

the accreditation fee(s). The fee(s) paid shall be nonrefundable and

shall be credited to the account from which the expenses of the

laboratory accreditation program are paid.

(iii) Annually on the anniversary date of each accreditation, FSIS

will issue a bill in the amount specified in 9 CFR 391.5.

(iv) Bills are payable upon receipt by check, bank draft, or money

order, made payable to the U.S. Department of Agriculture, and become

delinquent 30 days from the date of the bill. Accreditation will be

terminated without further procedure for having a delinquent account.

The fee(s) paid shall be nonrefundable and shall be credited to the

account from which the expenses of the Accredited Laboratory Program are

paid.

(v) The accreditation of a laboratory that was accredited by FSIS on

or before December 13, 1993 and was not on probation and whose

accreditation on that date was not in suspension or revocation shall be

continued, provided that such laboratory reapply for accreditation in

accordance with the provisions of this paragraph (c)(1), by January 12,

1994 (30 days of the effective date of this section), and that the

reapplication be accepted by the Agency. The CUSUM values for such

laboratory will be reset at zero upon acceptance of its reapplication.

The accreditation of a laboratory that is on probation shall be

continued, provided that such laboratory reapply for accreditation by

February 11, 1994 (60 days of the effective date of this section), that

the reapplication be accepted by the Agency, and that the laboratory

satisfy the terms of the probation.

(2) Criteria for obtaining accreditation. Non-Federal analytical

laboratories may be accredited for the analysis of a class of chemical

residues in meat and meat food products. Accreditation will be given

only if the applying laboratory successfully satisfies the requirements

presented below. This accreditation authorizes official FSIS acceptance

of the analytical test results provided by these laboratories on

official samples. To obtain FSIS accreditation for the analysis of a

class of chemical residues, a non-Federal analytical laboratory must:

[[Page 271]]

(i) Be supervised by a person holding, as a minimum, a bachelor's

degree in either chemistry, food science, food technology, or a related

field. Further, either the supervisor or the analyst assigned to analyze

the sample must have 3 years' experience determining analytes at or

below part per million levels, or equivalent qualifications, as

determined by the Administrator.

(ii) Demonstrate acceptable limits of systematic laboratory

difference, variability, individual large deviations, recoveries, and

proper identification in the analysis of the class of chemical residues

for which application was made, using FSIS approved procedures. An

applying laboratory will successfully demonstrate these capabilities if

its analytical results for each specific chemical residue provided in a

check sample accreditation study containing a minimum of 14 samples

satisfy the criteria presented in this paragraph (c)(2)(ii).\7\ In

addition, if the laboratory is requesting accreditation for the analysis

of chlorinated hydrocarbons, all analytical results for the residue

class must collectively satisfy the criteria. [Conformance to criteria

(c)(2)(ii) (A), (B), (C), (D), (E), and (F) will only be determined when

six or more analytical results with associated comparison means at or

above the logarithm of the minimum proficiency level are available.] If

the results of the first set of check samples do not meet these criteria

for obtaining accreditation, a second set of at least 14 samples will be

provided within 30 days following the date of receipt by FSIS of a

request from the applying laboratory. If the results of the second set

of samples do not meet accreditation criteria, the laboratory may

reapply after a 60-day waiting period, commencing from the date of

refusal of accreditation by FSIS. At that time, a new application, all

fees, and all documentation of corrective action required for

accreditation must be submitted.

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\7\ All statistical computations are rounded to the nearest tenth,

except where otherwise noted.

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(A) Systematic laboratory difference: The absolute value of the

average standardized difference must not exceed 1.67 (2.00 if there are

less than 12 analytical results) minus the product of 0.29 and the

standard deviation of the standardized differences.

(B) Variability: The standard deviation of the standardized

differences must not exceed a computed limit. This limit is a function

of the number of analytical results used in the computation of the

standard deviation, and of the amount of variability associated with the

results from the participating FSIS laboratories.

the large deviation measures of the individual analytical results must

be less than 5.0.\8\

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\8\ A result will have a large deviation measure equal to zero when

the absolute value of the result's standardized difference, (d), is less

than 2.5 and otherwise a measure equal 1-(2.5/d)\4\.

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(D) QA recovery: The average of the QA recoveries of the individual

analytical results must lie within the range given in Table 2 under the

column entitled ``Percent Expected Recovery.''

(E) QC recovery: All QC recoveries must lie within the range given

in Table 2 under ``Percent Expected Recovery.'' Supporting documentation

must be made available to FSIS upon request.

(F) Correct identification: There must be correct identification of

all chemical residues in all samples.

(iii) Allow inspection of the laboratory by FSIS officials prior to

the determination of granting accredited status.

(iv) Pay the accreditation fee by the date required.

(3) Criteria for maintaining accreditation. To maintain

accreditation for analysis of a class of chemical residues, a non-

Federal analytical laboratory must:

(i) [Reserved]

(ii) Maintain laboratory quality control records for the most recent

3 years that samples have been analyzed under this Program.

(iii) Maintain complete records of the receipt, analysis, and

disposition of official samples for the most recent 3 years that samples

have been analyzed under the Program.

(iv) Maintain a standards book, which is a permanently bound book

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