9 CFR 439.10 - Criteria for obtaining accreditation.

§ 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.

Title 9 published on 2014-01-01

no entries appear in the Federal Register after this date.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
U.S. Code: Title 7 - AGRICULTURE
U.S. Code: Title 21 - FOOD AND DRUGS

§ 451 - Congressional statement of findings

§ 452 - Congressional declaration of policy

§ 453 - Definitions

§ 454 - Federal and State cooperation in development and administration of State poultry product inspection programs

§ 455 - Inspection in official establishments

§ 456 - Operation of premises, facilities and equipment

§ 457 - Labeling and container standards

§ 458 - Prohibited acts

§ 459 - Compliance by all establishments

§ 460 - Miscellaneous activities subject to regulation

§ 461 - Offenses and punishment

§ 462 - Reporting of violations; notice; opportunity to present views

§ 463 - Rules and regulations

§ 464 - Exemptions

§ 465 - Limitations upon entry of poultry products and other materials into official establishments

§ 466 - Imports

§ 467 - Inspection services

§ 467a - Administrative detention; duration; pending judicial proceedings; notification of government authorities; release; removal of official marks

§ 467b - Seizure and condemnation

§ 467c - Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations; United States as plaintiff; subpenas

§ 467d - Administration and enforcement; applicability of penalty provisions; conduct of inquiries; power and jurisdiction of courts

§ 467e - Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments...purposes of adulterated or misbranded and imported articles; other matters

§ 467f - Federal Food, Drug, and Cosmetic Act applications

§ 468 - Cost of inspection; overtime

§ 469 - Authorization of appropriations

§ 470 - Omitted

§ 601 - Definitions

§ 602 - Congressional statement of findings

§ 603 - Examination of animals prior to slaughter; use of humane methods

§ 604 - Post mortem examination of carcasses and marking or labeling; destruction of carcasses condemned; reinspection

§ 605 - Examination of carcasses brought into slaughtering or packing establishments, and of meat food products issued from and returned thereto; conditions for entry

§ 606 - Inspection and labeling of meat food products

§ 607 - Labeling, marking, and container requirements

§ 608 - Sanitary inspection and regulation of slaughtering and packing establishments; rejection of adulterated meat or meat food products

§ 609 - Examination of animals and food products thereof, slaughtered and prepared during nighttime

§ 610 - Prohibited acts

§ 611 - Devices, marks, labels, and certificates; simulations

§ 612 - Notification

§ 613 - Plans and reassessments

§ 614 - Repealed.

§ 615 - Inspection of carcasses, meat of which is intended for export

§ 616 - Inspectors of carcasses, etc., meat of which is intended for export; certificates of condition

§ 617 - Clearance prohibited to vessel carrying meat for export without inspector’s certificate

§ 618 - Delivery of inspectors’ certificates, and of copies

§ 619 - Marking, labeling, or other identification to show kinds of animals from which derived; separate establishments for preparation and slaughtering activities

§ 620 - Imports

§ 621 - Inspectors to make examinations provided for; appointment; duties; regulations

§ 622 - Bribery of or gifts to inspectors or other officers and acceptance of gifts

§ 623 - Exemptions from inspection requirements

§ 624 - Storage and handling regulations; violations; exemption of establishments subject to non-Federal jurisdiction

§ 625 - Inapplicability of certain requirements to catfish

§ 641 - Prohibition of subchapter I inspection of articles not intended for use as human food; denaturation or other identification prior to distribution in commerce; inedible articles

§ 642 - Recordkeeping requirements

§ 643 - Registration of business, name of person, and trade names

§ 644 - Regulation of transactions, transportation, or importation of 4–D animals to prevent use as human food

§ 645 - Federal provisions applicable to State or Territorial business transactions of a local nature and not subject to local authority

§ 661 - Federal and State cooperation

§ 671 - Inspection services; refusal or withdrawal; hearing; business unfitness based upon certain convictions; other provisions...connection with business; finality of Secretary’s actions; judicial review; record

§ 672 - Administrative detention; duration; pending judicial proceedings; notification of governmental authorities; release

§ 673 - Seizure and condemnation

§ 674 - Federal court jurisdiction of enforcement and injunction proceedings and other kinds of cases; limitations of

§ 675 - Assaulting, resisting, or impeding certain persons; murder; protection of such persons

§ 676 - Violations

§ 677 - Other Federal laws applicable for administration and enforcement of chapter; location of inquiries; jurisdiction of Federal courts

§ 678 - Non-Federal jurisdiction of federally regulated matters; prohibition of additional or different requirements for establishments...purposes of adulterated or misbranded and imported articles; other matters

§ 679 - Application of Federal Food, Drug, and Cosmetic Act

§ 679a - Safe Meat and Poultry Inspection Panel

§ 679b - Pasteurization of meat and poultry

§ 679c - Expansion of Food Safety Inspection Service activities

§ 680 - Authorization of appropriations

§ 683 - Interstate shipment of meat inspected by Federal and State agencies for certain small establishments

§ 691 - Omitted

§ 692 - Inspection extended to reindeer

§ 693 - Inspection of dairy products for export

§ 694 - Authorization of appropriations

§ 695 - Payment of cost of meat-inspection service; exception