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Electronic Code of Federal Regulations

e-CFR Data is current as of October 22, 2014

Title 9Chapter IIISubchapter E → Part 439


Title 9: Animals and Animal Products


PART 439—ACCREDITATION OF NON-FEDERAL CHEMISTRY LABORATORIES


Contents
§439.1   Definitions.
§439.5   Applications for accreditation.
§439.10   Criteria for obtaining accreditation.
§439.20   Criteria for maintaining accreditation.
§439.50   Refusal of accreditation.
§439.51   Probation of accreditation.
§439.52   Suspension of accreditation.
§439.53   Revocation of accreditation.
§439.60   Notification and hearings.

Authority: 7 U.S.C. 138f, 450, 1901-1906; 21 U.S.C. 451-470, 601-695; 7 CFR 2.18, 2.53.

Source: 73 FR 52196, Sept. 9, 2008, unless otherwise noted.

§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 program in which non-Federal laboratories are accredited as eligible to perform analyses on official regulatory samples of raw or processed meat and poultry products, and through which a check 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 raw or processed meat or poultry products for the analytes 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—A sample provided by the ALP to a non-Federal laboratory to determine whether the laboratory's analytical capability meets the standards for granting accreditation.

(l) Inter-laboratory accreditation maintenance check sample—A sample provided by FSIS 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—The period commencing with official notification to an accredited laboratory that its check sample results no longer satisfy the performance requirements specified in this rule, 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—An action taken by FSIS when a laboratory that is applying for accreditation is denied the accreditation.

(w) 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) Revocation of accreditation—An action taken by FSIS against a laboratory, 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/classMoistureProtein1Fat1Salt1
<12.5%≥12.5%<1%1-4%≥4%2
Cured Pork/Canned Ham0.500.060 (X0.65)0.26 (X0.25)0.30 (X0.25)0.1270.127 (X0.25)0.22
Ground Beef0.710.060 (X0.65)N/A0.35 (X0.25)0.1270.127 (X0.25)0.22
Other Meat Products0.570.060 (X0.65)0.26 (X0.25)0.30 (X0.25)0.1270.127 (X0.25)0.22
Poultry Products0.570.060 (X0.65)0.26 (X0.25)0.30 (X0.25)0.1270.127 (X0.25)0.22

1The 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.

2For dry salami and pepperoni products.

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

Class of residuesStandardizing 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
Arsenic20.25
Sulfonamides20.25
Volatile Nitrosamine20.25

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

2Laboratory statistics are only computed for specific chemical residues.

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

(bb) Suspension of accreditation—Action taken by FSIS against a laboratory that temporarily removes the laboratory's right to analyze official samples. Suspension of accreditation ends when accreditation either is fully restored or is revoked.

(cc) Systematic laboratory difference—A comparison of one 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.

§439.5   Applications for accreditation.

(a) Application for accreditation shall be made on designated paper or electronic forms provided by FSIS, or otherwise in writing, by the owner or manager of a non-Federal analytical laboratory. The forms shall be sent to the ALP or may be submitted electronically when so provided for by FSIS. The application 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.

(b) At the time that an Application for Accreditation is filed with the ALP, the management of a laboratory shall, for each accreditation sought, submit 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). When so provided for by FSIS, electronic transfer of funds may be accepted.

(c) Accreditation will not be granted or continued, without further procedure, for failure to pay the accreditation fee(s). The fee(s) paid will be nonrefundable and will be credited to the account from which the expenses of the laboratory accreditation program are paid.

(d) Annually on the anniversary date of each accreditation, FSIS will issue a bill in the amount specified in 9 CFR 391.5 for each accreditation held. 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.

(e) Accreditation will be terminated without further procedure for having a delinquent account. The fee(s) paid will be nonrefundable and will be credited to the account from which the expenses of the ALP are paid.

§439.10   Criteria for obtaining accreditation.

(a) Analytical laboratories may be accredited for the analyses of food chemistry analytes, as defined in §439.1 of this part, or a specific chemical residue or a class of chemical residues in raw or processed meat and poultry products.

(b) Accreditation will be given only if the applying laboratory successfully satisfies the requirements presented below. For food chemistry accreditation, the requirements must be satisfied for all four analytes.

(c) This accreditation authorizes official FSIS acceptance of the analytical test results provided by these laboratories on official samples.

(d) To obtain FSIS accreditation, an analytical laboratory must:

(1) Be supervised by a person holding, at a minimum, a bachelor's degree in chemistry, food science, food technology, or a related field.

(i) For food chemistry accreditation, the supervisor must also have one year's experience in food chemistry analysis, or equivalent qualifications, as determined by the Administrator.

(ii) For chemical residue accreditation, either the supervisor or the analyst assigned to analyze the sample must also have three years' experience determining analytes at or below part per million levels, or equivalent qualifications, as determined by the Administrator.

(2) Demonstrate an ability to achieve quality assurance levels that are within acceptable limits for systemic laboratory difference, variability, and individual large deviations, in the analyte category for which accreditation is sought, using analytical procedures designated by the FSIS ALP as being acceptable. An applying laboratory will successfully demonstrate these capabilities for:

(i) Food chemistry if its results from a 36 check sample accreditation study each satisfy the criteria presented in paragraph (e) of this section.

(ii) Chemical residues if its analytical results for each specific chemical residue provided in a check sample accreditation study containing a minimum of 14 check samples satisfy the criteria presented in paragraph (e) of this section, including criteria for QA and QC recovery and for residue identification. 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 in paragraph (e) of this section 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.]

(3) Round all check sample statistical computations to the nearest tenth, except where otherwise noted.

(4) Complete a second set of the requisite number of check samples if the results of the first set of check samples do not meet the criteria for obtaining accreditation.

(i) The second set of 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 food chemistry check samples will be analyzed for only the analyte(s) for which unacceptable initial results had been obtained by the laboratory.

(ii) If the results of the second set of check samples do not meet the criteria for obtaining accreditation, 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.

(5) Allow inspection of the laboratory by FSIS officials prior to the determination of granting accredited status.

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

(e) Quality assurance levels—(1) Systematic laboratory difference: The absolute value of the average standardized difference must not exceed the following:

(i) For food chemistry, 0.73 minus the product of 0.17 and the standard deviation of the standardized differences; and

(ii) For chemical residues, 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.

(2) Variability: The estimated standard deviation of the standardized difference must not exceed the following:

(i) For food chemistry, 1.15; and

(ii) For chemical residues, a computed limit that is a function of the number of analytical results used in the computation of the standard deviation, and of the amount of variability.

(3) Individual large deviations: One hundred times the average of the large deviation measures of the individual samples must be less than 5.0. 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) For residue analyses, the following additional quality assurance requirements must be met.

(i) QA recovery: The average of the QA recoveries of the individual check sample analytical results must lie within ranges established by FSIS.

(ii) QC recovery: All QC recoveries must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon request.

(iii) Correct identification: There must be correct identification of all chemical residues in all samples.

§439.20   Criteria for maintaining accreditation.

(a) To maintain accreditation, an analytical laboratory must fulfill the requirements of paragraphs (b) through (i) of this section.

(b) Official samples. (1) An accredited laboratory must expeditiously report analytical results, in the analyte category for which accreditation was granted, of official samples on designated forms to the Data Center Staff, USDA/FSIS Eastern Laboratory, Russell Research Center, P.O. Box 6085, Athens, GA 30604 (for U.S. Postal Service delivery), or Data Center Staff, USDA/FSIS Eastern Laboratory, Russell Research Center, 950 College Station Road, Athens, GA 30605 (for commercial carrier delivery). When so provided for by FSIS, analytical results may be reported to the Data Center Staff by facsimile at (706) 546-3589, or electronically. 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.

(2) Every QC recovery associated with reporting of official samples must lie within ranges established by FSIS. Supporting documentation must be made available to FSIS upon request.

(c) Records. An accredited laboratory must:

(1) Maintain laboratory quality control records for the most recent three years that samples have been analyzed under this Program.

(2) Maintain complete records of the receipt, analysis, and disposition of official samples for the most recent three years that samples have been analyzed under this Program.

(3) Maintain in a secure electronic format or in a standards book, which is preferably a permanently bound book with sequentially numbered pages, all records, readings, and calculations for standard solutions. All entries are to be dated and signed by the analyst immediately upon completion of the entry, and by the supervisor, or in the absence of the supervisor by the supervisor's designee, before use of the standard solution but no later than within one week. The standards book is to be retained for three years after the last recorded entry.

(4) Maintain records and supervisor approvals of recoveries, and of instrument maintenance and calibration. The records are to be retained for three years after the last recorded entry.

(5) As provided in paragraph (f) of this section, records should be available for review by any duly authorized representative of the Secretary of Agriculture, including ALP personnel or their designees.

(d) Check samples. (1) An accredited laboratory must analyze interlaboratory accreditation maintenance check samples and return the results to FSIS within three weeks of sample receipt. This must be done whenever requested by FSIS and at no cost to FSIS.

(2) Results must be those of the accredited laboratory. Analyses of maintenance check samples shall not be contracted out by the accredited laboratory.

(3) As provided by the requirements in paragraph (h) of this section, a check sample report will be considered complete only if laboratories report all analytes present in the check sample for the analyte category in which accreditation was granted.

(e) Corporate changes. The ALP must be informed within 30 days of any change of address or in the laboratory's ownership, officers, directors, supervisory personnel, or other responsibly connected individual or entity.

(f) On-site review. An accredited laboratory must permit any duly authorized representative of the Secretary to perform both announced and unannounced on-site laboratory reviews of facilities and records, both hard copy and electronic, during normal business hours, and to copy any records pertaining to the laboratory's participation in the ALP.

(g) Analytical procedures. An accredited laboratory must use analytical procedures designated by the FSIS ALP as being acceptable.

(h) Quality assurance levels. (1) An accredited laboratory must demonstrate an ability to maintain quality assurance levels that are within acceptable limits for systematic laboratory difference, variability, and individual large deviations in the analysis of interlaboratory check samples for the analyte category for which accreditation was granted. An accredited laboratory will successfully demonstrate the maintenance of these capabilities if its analytical results from interlaboratory accreditation maintenance check samples satisfy the criteria presented in this paragraph (h). All statistical computations are to be rounded to the nearest tenth, except where otherwise noted.

(2) In addition, a laboratory accredited for a specific chemical residue or a chemical residue class:

(i) Must satisfy criteria presented in this paragraph for chemical residue recoveries and proper identification;

(ii) Must demonstrate the maintenance of its capabilities by reporting its analytical results for each specific chemical residue found above the minimum proficiency level; and

(iii) Must, if accredited for the analysis of chlorinated hydrocarbons, obtain analytical results that collectively satisfy the criteria.

(3) 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 two CUSUM values, designated as CUSUM-P and CUSUM-N.

(i) 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.

(ii) Positive systematic laboratory difference: This value is computed and evaluated as follows:

(A) Determine the CUSUM-P increment for the sample.

(1) The CUSUM-P increment for food chemistry, as defined in §439.1 of this part, is set equal to:

2.0, if the standardized difference is greater than 2.4,

−2.0, if the standardized difference is less than −1.6, or

the standardized difference minus 0.4, if the standardized difference lies between −1.6 and 2.4, inclusive.

(2) The CUSUM-P increment for chemical residues 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.

(B) Compute the new CUSUM-P value. The new CUSUM-P value is obtained by adding, algebraically, the CUSUM-P 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.

(C) Evaluate the new CUSUM-P value. The new CUSUM-P value must not exceed:

(1) 5.2 for food chemistry.

(2) 4.8 for chemical residues.

(iii) Negative systematic laboratory difference: This value is computed and evaluated as follows:

(A) Determine the CUSUM-N increment for the sample.

(1) The CUSUM-N increment for food chemistry 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, or

the standardized difference plus 0.4, if the standardized difference lies between −2.4 and 1.6, inclusive.

(2) The CUSUM-N increment for chemical residues 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, or

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

(B) Compute the new CUSUM-N value. The new CUSUM-N value is obtained by subtracting, algebraically, the CUSUM-N increment from 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.

(C) Evaluate the new CUSUM-N value. The new CUSUM-N value must not exceed:

(1) 5.2 for food chemistry.

(2) 4.8 for chemical residues.

(4) Variability: The absolute value of 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-V.

(i) 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.

(ii) The variability value is computed and designated as follows:

(A) Determine the CUSUM-V 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.

(B) Compute the new CUSUM-V value. The new CUSUM-V value is obtained by adding, algebraically, the CUSUM-V 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.

(C) Evaluate the new CUSUM-V value. The new CUSUM-V value must not exceed 4.3.

(5) 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.

(i) 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).

(ii) The large deviation value is computed and evaluated as follows:

(A) Determine the CUSUM-D increment for the sample. The CUSUM increment is set equal to the value of the large deviation measure minus 0.025.

(B) Compute the new CUSUM-D value. The new CUSUM-D value is obtained by adding, algebraically, the CUSUM-D 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.

(C) Evaluate the new CUSUM-D value. The new CUSUM-D value must not exceed 1.0.

(6) For chemical residues:

(i) Each QC recovery must lie within ranges established by FSIS.

Supporting documentation must be made available to FSIS upon request.

(ii) Not more than one residue misidentification may be made in any two consecutive check samples.

(iii) Not more than two residue misidentifications may be made in any eight consecutive check samples.

(i) Fees. An accredited laboratory must pay the required accreditation fee when it is due.

(j) Probation. An accredited laboratory must meet the following requirements if placed on probation pursuant to §439.51 of this part:

(1) 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 and as directed by FSIS, to a laboratory accredited by FSIS for the designated analyte(s). Mailing expenses will be paid by FSIS.

(2) Analyze a set of check samples similar to those used for initial accreditation, and submit the analytical results to FSIS within three weeks of receipt of the samples.

(3) Satisfy criteria for accreditation check samples specified in §439.10 of this part.

§439.50   Refusal of accreditation.

Upon a determination by the Administrator, a laboratory will be refused accreditation for the following reasons:

(a) A laboratory will be refused accreditation for failure to meet the requirements of §439.5 or §439.10 of this part.

(b) A laboratory will be refused subsequent accreditation for failure to return to an FSIS laboratory, by certified mail or private carrier, or, as an alternative and as directed by FSIS, to a laboratory accredited by FSIS for the designated analytes, all official samples that have not been analyzed as of the notification of a loss of accreditation.

(c) A laboratory will be refused accreditation if the laboratory or any individual or entity responsibly connected with the laboratory has been convicted of, or is under indictment for, or has charges on an information brought against them in a 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.

§439.51   Probation of accreditation.

Upon a determination by the Administrator, a laboratory will be placed on probation for the following reasons:

(a) If the laboratory fails to complete more than one interlaboratory accreditation maintenance check sample analysis as required by §439.20(d) of this part within 12 consecutive months, unless written permission is granted by the Administrator.

(b) If the laboratory fails to meet any of the criteria set forth in §§439.20(d) and 439.20(h) of this part.

§439.52   Suspension of accreditation.

The accreditation of a laboratory will be suspended if the laboratory or any individual or entity responsibly connected with the laboratory is indicted or has charges on information brought against them in a Federal or State court for any of the following violations of law:

(a) Any felony.

(b) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.

(c) Any misdemeanor based upon a false statement to any governmental agency.

(d) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.

§439.53   Revocation of accreditation.

The accreditation of a laboratory will be revoked for the following reasons:

(a) An accredited laboratory that is accredited to perform analysis under §§439.5, 439.10 and 439.20 of this part will have its accreditation revoked for failure to meet any of the requirements of §439.20 of this part, except for the following circumstances. If the accredited laboratory fails to meet any of the criteria set forth in §§439.20(d) and 439.20(h) of this part and it has not failed during the 12 months preceding its failure to meet the criteria, it shall be placed on probation, but if it has failed at any time during those 12 months, its accreditation will be revoked.

(b) An accredited laboratory will have its accreditation revoked if the Administrator determines that the laboratory or any responsibly connected individual or any agent or employee has:

(1) Altered any official sample or analytical finding; or

(2) Substituted any analytical result from any other laboratory and represented the result as its own.

(c) An accredited laboratory will have its accreditation revoked if the laboratory or any individual or entity responsibly connected with the laboratory is convicted in a Federal or State court of any of the following violations of law:

(a) Any felony.

(b) Any misdemeanor based upon acquiring, handling, or distributing of unwholesome, misbranded, or deceptively packaged food or upon fraud in connection with transactions in food.

(c) Any misdemeanor based upon a false statement to any governmental agency.

(d) Any misdemeanor based upon the offering, giving or receiving of a bribe or unlawful gratuity.

§439.60   Notification and hearings.

Accreditation of any laboratory will be refused, suspended, or revoked under the conditions previously described in this Part 439. The owner or operator of the laboratory will 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 will be granted if there is any dispute of material fact joined in such responsive statement. The proceeding will be conducted thereafter in accordance with the applicable rules of practice, which will be adopted for the proceeding. Any such refusal, suspension, or revocation will be effective upon the receipt by the laboratory of the notification and will continue in effect until final determination of the matter by the Administrator.



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