§ 439.1 - Definitions.

§ 439.1 Definitions.

(a) Accreditation - Determination by FSIS that a laboratory is qualified to analyze official samples of raw or processed meat and poultry products, because it has met the requirements for accreditation specified in this part, 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 raw or processed meat and poultry products, because it has met the requirements for accreditation in this part, for the presence and amount of a specified chemical residue of any one of several classes of chemical residues. A laboratory may hold more than one accreditation.

(b)

Accredited

laboratory - A non-Federal analytical laboratory that has met the requirements for accreditation specified in this Part and, therefore, 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. (c) Accredited

Laboratory Program (ALP)

- The FSIS

. The voluntary Food Safety and Inspection Service (FSIS) program in which non-Federal laboratories are accredited as

eligible to perform analyses on official regulatory

capable of performing analyses with the level of quality that is necessary to maintain accreditation in the program, on samples of raw or processed meat, poultry, and

poultry

egg products, and through which a

check

proficiency testing sample program for quality assurance is conducted.

(

d) Chemical residue misidentification - see “Correct chemical residue identification” definition.

(e) Coefficient of variation (CV) - The standard deviation of a distribution of analytical values multiplied by 100 and divided by the mean of those values.

(f) Comparison mean - The average result, for a sample, obtained from all submitted results that have a large deviation measure of zero. When only two laboratories perform the analysis and the large deviation measure is not zero, alternative procedures for establishing a comparison mean may be employed by FSIS. For purposes of computing the comparison mean, a laboratory's “result” for a food chemistry analyte is the obtained analytical value; a laboratory's “result” for a chemical residue is the logarithmic transformation of the obtained analytical value.

(g) Correct chemical residue identification - Reporting by a laboratory of the presence and analytical value of a chemical residue that was included in the ALP check sample above the minimum reporting level. Failure of a laboratory to report the presence of such a chemical residue is considered a misidentification. In addition, reporting the presence of and analytical value for a residue that was not included in the ALP check sample above the minimum reporting level is considered a misidentification.

(h) 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 CUSUM values are reset to zero at the beginning of each year; that is, the CUSUM values associated with the first maintenance check sample each year are set equal to the CUSUM increment for that sample. The four CUSUM procedures are:

(1) Positive systematic 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 deviation” (i.e., the combination of the random fluctuations and systematic differences) between an accredited laboratory's results and the comparison mean; and

(4) Individual large deviation CUSUM (CUSUM-D) - monitors the magnitude and frequency of large differences between the results of an accredited laboratory and the comparison mean.

(i) Food chemistry - For the purposes of part 439, “food chemistry” will refer to analysis of

b) Food chemistry. Analysis of raw or processed meat or poultry products for the

analytes

components moisture, protein, fat, and salt.

All four analytes must be determined when a food chemistry analysis is conducted, unless otherwise advised by the ALP.

(j) Individual large deviation - An analytical result that differs from the sample comparison mean by more than would be expected assuming normal laboratory variability.

(k) Initial accreditation check sample -

(c) Initial accreditation proficiency testing sample. A sample provided by the FSIS ALP to a non-Federal laboratory to determine whether the laboratory's analytical capability meets the standards for

granting accreditation. (l)

acceptance into the program. The concentration or presence of the targeted analyte(s) and the composition of the components in the sample is unknown to the laboratory.

(d) Inter-laboratory accreditation maintenance

check

proficiency testing sample

-

. A sample provided by the FSIS ALP to an accredited laboratory to assist in determining whether the laboratory is maintaining acceptable

levels of analytical capability.

(m) Large deviation measure - A measure that quantifies an unacceptably large difference between a laboratory's analytical result and the sample comparison mean.

(n) Minimum proficiency level (MPL) - 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.

(o) Minimum reporting level (MRL) - The number such that if any obtained analytical value for a residue in a check sample or official sample equals or exceeds this number, then the residue is reported together with the obtained analytical value.

(p) Official sample - A sample selected by an inspector or inspection service employee in accordance with FSIS procedures for regulatory use.

(q) Probation -

analytical performance for a given analyte or component. The concentration or presence of the targeted analyte(s) and the composition of the components in the sample is unknown to the laboratory.

(e) International Organization for Standardization (ISO) 13528. ISO 13528:2015(E) Corrected version 2016, “Statistical methods for use in proficiency testing by interlaboratory comparison,” October 15, 2016, or updated versions.

(f) Probation. The period commencing with official notification to an accredited laboratory that

its check sample results

it no longer

satisfy

satisfies the ALP performance requirements specified in this

rule,

part and ending with official notification that accreditation

either

is fully restored, is suspended, or is revoked.

(

r) QA (See Quality assurance recovery).

(s) QC (See Quality control recovery).

(t) Quality assurance (QA) recovery - The ratio of a laboratory's analytical value for a check sample residue to the established level of the analyte in the check sample, multiplied by 100. As dictated by the procedures for the analyte, the analytical value may be adjusted prior to the recovery computation.

(u) Quality control (QC) recovery - The ratio of a laboratory's analytical value of a quality control standard to the established level of the analyte in the standard, multiplied by 100. As dictated by the procedures for the analyte, the analytical value may be adjusted prior to the recovery computation.

(v) Refusal of accreditation -

g) Refusal of accreditation. An action taken by FSIS when a laboratory that is applying for accreditation is denied the accreditation.

(

w

h)Responsibly connected

-

. Any individual, or entity, that is a partner, officer, director, manager, or owner of 10 percent 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.

(

x

i)Revocation of accreditation

-

. An action taken by FSIS against a laboratory

,

thereby removing the laboratory's

right to analyze official samples.

(y) Standardizing constant - A number that results from a mathematical adjustment to the “standardizing value” and is used to compute the standardized difference for a check sample result. The number takes into consideration the expected variance of the difference between the accredited or applying laboratory's result(s) and the comparison mean for a sample, the standardizing value, the correlation and number of repeated results by a laboratory on a sample, and the number of laboratories that analyzed a sample.

(z) 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.

(aa) Standardizing value - A number representing the performance standard deviation of an individual result. The number is given, or computed by, the information provided in Tables 1 and 2 to this paragraph (aa).

Table 1 to Paragraph (aa) - Standardizing Values for Food Chemistry

[By product class and analyte]

Product/class	Moisture	Protein1	Fat1		Salt1
			<12.5%	≥12.5%	<1%	1-4%	≥4%2
Cured Pork/Canned Ham	0.50	0.060 (X0.65)	0.26 (X0.25)	0.30 (X0.25)	0.127	0.127 (X0.25)	0.22
Ground Beef	0.71	0.060 (X0.65)	N/A	0.35 (X0.25)	0.127	0.127 (X0.25)	0.22
Other Meat Products	0.57	0.060 (X0.65)	0.26 (X0.25)	0.30 (X0.25)	0.127	0.127 (X0.25)	0.22
Poultry Products	0.57	0.060 (X0.65)	0.26 (X0.25)	0.30 (X0.25)	0.127	0.127 (X0.25)	0.22

¹ The standardizing value is either the value given in the table or is computed by the formula set forth in the table, where X is the comparison mean of the sample. Standardizing values are provided for different percentages of fat and salt as indicated in the table.

² For dry salami and pepperoni products.

Table 2 to Paragraph (aa) - Standardizing Values for Chemical Residues

Class of residues Standardizing value³ Chlorinated Hydrocarbons:¹ Aldrin0.20 Benzene Hexachloride0.20 Chlordane0.20 Dieldrin0.20 DDT0.20 DDE0.20 TDE0.20 Endrin0.20 Heptachlor0.20 Heptachlor Epoxide0.20 Lindane0.20 Methoxychlor0.20 Toxaphene0.20 Hexachlorobenzene0.20 Mirex0.20 Nonachlor0.20 Polychlorinated Biphenyls:0.20 Arsenic² 0.25 Sulfonamides² 0.25 Volatile Nitrosamine² 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.

(bb) Suspension of accreditation - Action

certification of accreditation and participation in inter-laboratory accreditation maintenance proficiency testing sample events.

(j) Suspension of accreditation. An action taken by FSIS against a laboratory

that

thereby temporarily

removes

removing the laboratory's

right to analyze official samples

certification of accreditation and participation in the inter-laboratory accreditation maintenance proficiency testing sample events. Suspension of accreditation ends when accreditation either is fully restored or is revoked.

(

cc) Systematic laboratory difference - A comparison of one

k) z score. A statistically derived number representing a laboratory's

results with the comparison mean for samples that show, 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. Conversely, numerically smaller results indicate a negative systematic laboratory difference.

(dd) Variability - Random fluctuations in a laboratory's processes that cause its analytical results to deviate from a true value.

(ee) Variance - The expected average of the squared differences of sample results from an expected sample mean

performance for analyzing quantitative proficiency testing samples. The ALP calculates and interprets z scores consistent with the ISO 13528 standard.