Section

[Code of Federal Regulations]
[Title 9, Volume 2, Parts 200 to end]
[Revised as of January 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR318.21]

[Page 254-268]

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.
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

[[Page 255]]

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 misidentification.
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.
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

[[Page 256]]

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]
----------------------------------------------------------------------------------------------------------------
Product/Class Moisture Protein \1\ Fat \2\ Salt \3\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\1\ To obtain the standardizing value for a sample the appropriate entry in this column is multiplied by X^0.65
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 X^0.25,
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 X^0.25. When X
is equal to or greater than 4.0 percent for dry salami and pepperoni products, the standardizing value equals
0.22.

[[Page 257]]

Table 2--Minimum Proficiency Levels, Percent Expected Recoveries (QC and QA), and Standardizing Values for
Chemical Residues
----------------------------------------------------------------------------------------------------------------
Percent expected
Class of residues Minimum recovery (QC and Standardizing
proficiency level QA) value \3\
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
\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, room 516-A, Annex Building, Food
Safety and Inspection Service, U.S. Department of Agriculture, 300 12th
Street SW., 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

[[Page 258]]

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 (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.
(C) Individual large deviations: One hundred times the average of
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 259]]

Box 6085, Athens, GA 30604, or to the address designated by the Quality
Systems Branch, FSIS Chemistry Division.
(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, room 516-A, Annex
Building, Food Safety and Inspection Service, U.S. Department of
Agriculture, 300 12th Street, SW., 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 CUSUM-P value is set equal to 0. [CUSUM-P values
are initialized at zero; that is, the CUSUM-P value associated with the
first sample is set equal to the CUSUM increment for that sample.]

[[Page 260]]

(iii) Evaluate the new CUSUM-P value. The new CUSUM-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 CUSUM-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 CUSUM-N value. The new CUSUM-N value is
obtained by subtracting, algebraically, the CUSUM increment to the last
previously computed CUSUM-N value. If this computation yields a value
smaller than 0, the new CUSUM-N value is set equal to 0. [CUSUM-N values
are initialized at zero; that is, the CUSUM-N value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-N value. The new CUSUM-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 CUSUM-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 CUSUM-V value. The new CUSUM-V value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-V value. If this computation yields a value less than 0,
the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized
at zero; that is, the CUSUM-V value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not
exceed 4.3.
(C) Large deviations: The large deviation measure of the accredited
laboratory's result for each split sample or interlaboratory
accreditation maintenance check sample is used to determine a CUSUM
value, designated as CUSUM-D.\6\ This value is computed and evaluated as
follows:
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\6\ See footnote 3.
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[[Page 261]]

(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 Quality Systems
Branch, FSIS Chemistry Division. 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.
(c) Laboratories accredited for analysis of a class of chemical
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, room 516-A, Annex Building,
Food Safety and Inspection Service, U.S. Department of Agriculture, 300
12th Street, SW., 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

[[Page 262]]

residues, 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. 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.
---------------------------------------------------------------------------

(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.
(C) Individual large deviations: One hundred times the average of
the large deviation measures of the individual analytical results must
be less than 5.0.\8\
---------------------------------------------------------------------------

\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\.
---------------------------------------------------------------------------

(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.

[[Page 263]]

(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, room 516-A, Annex
Building, Food Safety and Inspection Service, U.S. Department of
Agriculture, 300 12th Street, SW., Washington, DC 20250-3700, by
certified or registered mail, within 30 days of any change in the
laboratory's ownership, officers, directors, supervisory personnel, or
any 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 analytical procedures designated and approved by FSIS.
(ix) Demonstrate that acceptable limits of systematic laboratory
difference, variability, and individual large deviations are being
maintained in the analysis of samples, in the chemical residue class for
which accreditation was granted. A laboratory will successfully
demonstrate the maintenance of these capabilities if its analytical
results for each specific chemical residue found in interlaboratory
accreditation maintenance check samples and/or split samples satisfy the
criteria presented in this paragraph (c)(3)(ix).\9,10\ In addition, if
the laboratory is accredited for the analysis of chlorinated
hydrocarbons, all analytical results for the residue class must
collectively satisfy the criteria.
---------------------------------------------------------------------------

\9\ All statistical computations are rounded to the nearest tenth,
except where otherwise noted.
\10\ An analytical result will only be used in the statistical
evaluation of the laboratory if the associated comparison mean is equal
to or greater than the logarithm of the minimum proficiency level for
the residue.
---------------------------------------------------------------------------

(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 and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-P.\11\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

\11\ When determining compliance with this criterion for all
chlorinated hydrocarbon results in a sample collectively, the following
statistical procedure must be followed to account for the correlation of
analytical results within a sample: the average of the standardized
differences of the analytical results within the sample, divided by a
constant, is used in place of a single standardized difference to
determine the CUSUM-P (or CUSUM-N) value for the sample. The constant is
a function of the number of analytical results used to compute the
average standardized difference.
---------------------------------------------------------------------------

(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:

2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,

the standardized difference minus 0.5, if the standardized difference
lies between -1.5 and 2.5, inclusive.

[[Page 264]]

(2) Negative systematic laboratory difference: The standardized
difference between the accredited laboratory's result and that of the
FSIS laboratory for each split and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-N.\12\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

\12\ See footnote 11.
---------------------------------------------------------------------------

(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:

2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,

the standardized difference plus 0.5, if the standardized difference
lies between -2.5 and 1.5, inclusive.

\13\ When determining compliance with this criterion for all
chlorinated hydrocarbon results in a sample collectively, the following
statistical procedure must be followed to account for the correlation of
analytical results within a sample: the square root of the sum of the
within sample variance and the average standardized difference of the
sample, divided by a constant, is used in place of the absolute value of
the standardized difference to determine the CUSUM-V value for the
sample. The constant is a function of the number of analytical results
used to compute the average standardized difference.
---------------------------------------------------------------------------

(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 CUSUM-V value. The new CUSUM-V value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-V value. If this computation yields a value less than 0,
the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized
at zero; that is, the CUSUM-V value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not
exceed 4.3.
(C) Large Deviations: The large deviation measure of the accredited
laboratory's result for each split and/or interlaboratory accreditation
maintenance check sample is used to determine a CUSUM value, designated
as CUSUM-D.\14\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

\14\ 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\.
---------------------------------------------------------------------------

(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the large deviation measure minus 0.025.
(2) Compute the new CUSUM-D value. The new CUSUM-D is obtained by
adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-D value. If this computation yields a value less than 0,
the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized
at zero; that is, the CUSUM-D value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not
exceed 1.0.
(x) Meet the following requirements if placed on probation pursuant
to paragraph (e) of this section:

[[Page 265]]

(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 accredited for this specific chemical residue.
Mailing expense will be paid by FSIS.
(B) Analyze a set of check samples similar to those used for initial
accreditation, and submit analytical results to FSIS within 3 weeks of
receipt of the samples.
(C) Satisfy criteria for check samples as specified in paragraphs
(c)(2)(ii) (A), (B), (C), (D), (E), and (F) of this section.
(xi) Expeditiously report analytical results of official samples to
the Eastern Laboratory, College Station Road, P.O. Box 6085, Athens, GA
30604, or to the address designated by the Quality Systems Branch, FSIS
Chemistry Division. The Federal inspector at any establishment may
assign the analysis of official samples to an FSIS laboratory if, in the
judgment of the inspector, there are delays in receiving test results on
official samples from an accredited laboratory.
(xii) Every QC recovery associated with reporting of official
samples must be within the appropriate range given in Table 2 under
``Percent Expected Recovery.'' Supporting documentation must be made
available to FSIS upon request.
(xiii) Demonstrate that acceptable levels of systematic laboratory
difference, variability, individual large deviations, recoveries, and
proper identification are being maintained in the analysis of
interlaboratory accreditation maintenance check samples, in the chemical
residue class for which accreditation was granted. A laboratory will
successfully demonstrate the maintenance of these capabilities if its
analytical results for each specific chemical residue found in
interlaboratory accreditation maintenance check samples satisfy the
criteria presented below. In addition, if the laboratory is accredited
for the analysis of chlorinated hydrocarbons, all analytical results for
the residue class must collectively satisfy the criteria.
(A) Systematic laboratory difference--(1) Positive systematic
laboratory difference: The standardized difference between the
accredited laboratory's result and the comparison mean for each
interlaboratory accreditation maintenance check sample is used to
determine a CUSUM value, designated as CUSUM-P.\15\ This value is
computed and evaluated as follows:
---------------------------------------------------------------------------

\15\ See footnote 11.
---------------------------------------------------------------------------

(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:

2.0, if the standardized difference is greater than 2.5,
-2.0, if the standardized difference is less than -1.5,
or

the standardized difference minus 0.5, if the standardized difference
lies between -1.5 and 2.5, 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 CUSUM-P value is set equal to 0. [CUSUM-P values
are initialized at zero; that is, the CUSUM-P value associated with the
first sample is set equal to the CUSUM increment for that sample.]
(iii) Evaluate the new CUSUM-P value. The new CUSUM-P value must not
exceed 4.8.
(2) Negative systematic laboratory difference: The standardized
difference between the accredited laboratory's result and the comparison
mean for each interlaboratory accreditation maintenance check sample is
used to determine a CUSUM value, designated as CUSUM-N.\16\ This value
is computed and evaluated as follows:
---------------------------------------------------------------------------

\16\ See footnote 11.
---------------------------------------------------------------------------

(i) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to:

2.0, if the standardized difference is greater than 1.5,
-2.0, if the standardized difference is less than -2.5,

the standardized difference plus 0.5, if the standardized difference
lies between -2.5 and 1.5, inclusive.

[[Page 266]]

\17\ See footnote 13.
---------------------------------------------------------------------------

(1) Determine the CUSUM increment for the sample. The CUSUM
increment is set equal to the larger of -0.4 or 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 CUSUM-V value. The new CUSUM-V value is obtained
by adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-V value. If this computation yields a value less than 0,
the new CUSUM-V value is set equal to 0. [CUSUM-V values are initialized
at zero; that is, the CUSUM-V value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-V value. The new CUSUM-V value must not
exceed 4.3.
(C) Large deviations: The large deviation measure of the accredited
laboratory's result for each interlaboratory accreditation maintenance
check sample is used to determine a CUSUM value, designated as CUSUM-
D.\18\ This value is computed and evaluated as follows:
---------------------------------------------------------------------------

\18\ 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\.
---------------------------------------------------------------------------

(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 CUSUM-D value. The new CUSUM-D is obtained by
adding, algebraically, the CUSUM increment to the last previously
computed CUSUM-D value. If this computation yields a value less than 0,
the new CUSUM-D value is set equal to 0. [CUSUM-D values are initialized
at zero; that is, the CUSUM-D value associated with the first sample is
set equal to the CUSUM increment for that sample.]
(3) Evaluate the new CUSUM-D value. The new CUSUM-D value must not
exceed 1.0.
(D) Each QC Recovery is within the range given in Table 2 under
``Percent Expected Recovery''. Supporting documentation must be made
available to FSIS upon request.
(E) Not more than 1 residue misidentification in any 2 consecutive
check samples.
(F) Not more than 2 residue misidentifications in any 8 consecutive
check samples.
(xiv) Pay the accreditation fee when it is due.
(d) Refusal of accreditation. Upon a determination by the
Administrator, a laboratory shall be refused accreditation for the
following reasons:
(1) A laboratory shall be refused accreditation for moisture,
protein, fat, and salt analysis for failure to meet the requirements of
paragraph (b)(1) or (b)(2) of this section.
(2) A laboratory shall be refused accreditation for chemical residue
analysis for failure to meet the requirements of paragraph (c)(1) or
(c)(2) of this section.
(3) A laboratory shall be refused subsequent accreditation for
failure to return to an FSIS laboratory, by certified mail or private
carrier, all official samples which have not been analyzed as of the
notification of a loss of accreditation.
(4) A laboratory shall be refused accreditation if the applicant or
any individual or entity responsibly connected with the applicant has
been convicted

[[Page 267]]

of or is under indictment or if charges on an information have been
brought against the applicant or responsibly connected individual or
entity in any Federal or State court concerning the following violations
of law:
(i) Any felony.
(ii) Any misdemeanor based upon acquiring, handling, or distributing
of unwholesome, misbranded, or deceptively packaged food or upon fraud
in connection with transactions in food.
(iii) Any misdemeanor based upon a false statement to any
governmental agency.
(iv) Any misdemeanor based upon the offering, giving or receiving of
a bribe or unlawful gratuity.
(e) Probation of accreditation. Upon a determination by the
Administrator, a laboratory shall be placed on probation for the
following reasons:
(1) If the laboratory fails to complete more than one
interlaboratory accreditation maintenance check sample analysis within
12 consecutive months as required by paragraphs (b)(3)(v) and (c)(3)(v)
of this section.
(2) If the laboratory fails to meet any of the criteria set forth in
paragraphs (b)(3)(v) and ((b)(3)(ix) and (c)(3)(v) and (c)(3)(ix) of
this section.
(f) Suspension of accreditation. The accreditation of a laboratory
shall be suspended if the laboratory or any individual or entity
responsibly connected with the laboratory is indicted or if charges on
an information have been brought against the laboratory or responsibly
connected individual or entity in any Federal or State court concerning
any of the following violations of law:
(1) Any felony.
(2) Any misdemeanor based upon acquiring, handling or distributing
of unwholesome, misbranded, or deceptively packaged food or upon fraud
in connection with transactions in food.
(3) Any misdemeanor based upon a false statement to any governmental
agency.
(4) Any misdemeanor based upon the offering, giving or receiving of
a bribe or unlawful gratuity.
(g) Revocation of accreditation. The accreditation of a laboratory
shall be revoked for the following reasons:
(1) An accredited laboratory which is accredited to perform analysis
under paragraph (b) of this section shall have its accreditation revoked
for failure to meet any of the requirements of paragraph (b)(3) of this
section except for the following circumstances. If the accredited
laboratory fails to meet the criteria for reporting the analytical
results on interlaboratory accreditation maintenance check samples as
set forth in paragraph (b)(3)(v) of this section or if, at any time, the
CUSUM results from the analysis of such interlaboratory accreditation
maintenance check samples and/or split samples have not satisfied the
criteria specified in paragraph (b)(3)(ix) of this section and there
have been, during the previous 12 months, no other occasions on which
such CUSUM results have not satisfied such criteria, the laboratory
shall be placed on probation; but if there have been such other
occasions during those 12 months, the laboratory's accreditation will be
revoked.
(2) An accredited laboratory which is accredited to perform analysis
for a class of chemical residues under paragraph (c) of this section
shall have the accreditation to perform this analysis revoked if it
fails to meet any of the requirements in paragraph (c)(3) of this
section except for the following circumstances. If the accredited
laboratory fails to meet any of the criteria set forth in paragraphs
(c)(3)(v), (c)(3)(ix), and (c)(3)(xiii) of this section and it has not
so failed during the 12 months preceding its failure to meet the
criteria, it shall be placed on probation, but if it has so failed at
any time during those 12 months, its accreditation will be revoked.
(3) An accredited laboratory shall have its accreditation revoked if
the Administrator determines that the laboratory or any responsibly
connected individual or any agent or employee has:
(i) Altered any official sample or analytical finding, or,
(ii) Substituted any analytical result from any other laboratory for
its own.
(4) An accredited laboratory shall have its accreditation revoked if
the laboratory or any individual or entity responsibly connected with
the laboratory is convicted in a Federal or State

[[Page 268]]

court of any of the following violations of law:
(i) Any felony.
(ii) Any misdemeanor based upon acquiring, handling, or distributing
of unwholesome, misbranded, or deceptively packaged food or upon fraud
in connection with transactions in food.
(iii) Any misdemeanor based upon a false statement to any
governmental agency.
(iv) Any misdemeanor based upon the offering, giving or receiving of
a bribe or unlawful gratuity.
(h) Notification and hearings. Accreditation of any laboratory shall
be refused, suspended, or revoked under the conditions previously
described herein. The owner or operator of the laboratory shall be sent
written notice of the refusal, suspension, or revocation of
accreditation by the Administrator. In such cases, the laboratory owner
or operator will be provided an opportunity to present, within 30 days
of the date of the notification, a statement challenging the merits or
validity of such action and to request an oral hearing with respect to
the denial, suspension, or revocation decision. An oral hearing shall be
granted if there is any dispute of material fact joined in such
responsive statement. The proceeding shall thereafter be conducted in
accordance with the applicable rules of practice which shall be adopted
for the proceeding. Any such refusal, suspension, or revocation shall be
effective upon the receipt by the laboratory of the notification and
shall continue in effect until final determination of the matter by the
Administrator.

(Reporting and recordkeeping requirements approved by the Office of
Management and Budget under control number 0583-0015)

[52 FR 2185, Jan. 20, 1987, as amended at 58 FR 65260, 65262-65264, Dec.
13, 1993; 59 FR 33642, June 30, 1994; 59 FR 66448, Dec. 27, 1994; 60 FR
10305, Feb. 24, 1995]