Sec.

PART 90-INTRODUCTION Subpart A-Scope of Subchapter

SOURCE: 58 FR 42414, Aug. 9, 1993, unless otherwise noted.

Subpart A-Scope of Subchapter § 90.1 General.

This subchapter sets forth the functions and responsibilities of the Science and Technology Division (S&TD) of the Agricultural Marketing Service (AMS) relating to:

(a) The performance of comprehensive analytical tests and laboratory determinations of agricultural commodities and processed products.

(b) The conduct of experiments and collaborative studies to validate new analytical procedures and improved methodologies in order to promote faster, more precise, or safer laboratory testing for agricultural commodities and processed products.

(c) The supervised issuance of external quality control or proficiency check samples to laboratories under the Science and Technology Division's direction or performance review in order to regularly spot check and assess that analytical or test data produced by each laboratory is reproducible, precise, and reliable for a specific test program.

(d) The granting of laboratory program accreditation or certification or approval for specialty testing of agricultural commodities and products.

(e) The licensing of chemists to analyze cottonseed in order to certify its quality and grade.

(f) The granting of certification to non-federal laboratories for testing for trichinae in horsemeat for export to the European Community (EC).

(g) The granting of acceptance of standardized methodology or new procedures for commodity testing.

(h) The auditing of the facilities, equipment, quality control procedures, standard methodologies, and good laboratory practices for a commodity testing program of a laboratory.

(i) The examination of plants for novelty and distinctiveness in order to grant certificates of protection for new varieties of sexually reproduced plants, and the provision of other fee based services authorized by the Plant Variety Protection Act.

(j) The extension or coordination of research for the determination of a new chemical analyte or microorganism in a commodity product or food.

(k) The analysis of imported fluecured and burley tobacco for pesticide residues.

(1) The supervision and implementation of the State enforcement of the recordkeeping requirements for private applicators of restricted-use pesticides for agricultural production.

[58 FR 42414, Aug. 9, 1993, as amended at 61 FR 51350, Oct. 2, 1996]

Subpart B-Subchapter Definitions

§ 90.2 General terms defined.

Words used in the regulations in this subchapter in the singular form will import the plural, and vice versa, as the case may demand. As used throughout the regulations in this subchapter and unless the context requires otherwise, the following terms will be construed to mean:

Act. The Agricultural Marketing Act of 1946 (Title II of the act of Congress

approved August 14, 1946, 60 Stat. 10871091, as amended; 7 U.S.C. 1621-1627).

Administrator. The Administrator of the Agricultural Marketing Service, or any officer or employee of the Service, to whom authority has been delegated, or to whom authority may be delegated, to act in his or her stead.

Cooperative agreement. An agreement between the Agricultural Marketing Service and another Federal agency or a State agency, or other agency, organization or person that defines in the general terms the basis on which the parties concerned will cooperate to serve a mutual interest on an agricultural service project. The responsibilities for AMS and each cooperator are stated in the document along with the conditions as applicable.

Department. The United States Department of Agriculture.

Director. The Director of the Science and Technology Division, or any officer or employee of the Division to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his or her stead.

Division. The Science and Technology Division (S&TD) of the Agricultural Marketing Service (AMS), which performs analytical testing services, issues licenses for cottonseed chemists, conducts quality assurance reviews and grants accreditation or certification for commodity testing programs of laboratories.

Laboratories. Division laboratories performing the analyses described in this subchapter.

Quality assurance. The assurance that there is accuracy of analytical data using proficiency check sample or analyte recovery techniques. In addition, the certainty that there is strict adherence by the analysts in following the quality control details in the recommended or official methods for reagents, laboratory apparatus and procedures. The overall objective of quality assurance, as a comprehensive program, is to ensure that all analytical data produced by the laboratory meets certain quality criteria and that all data produced is reproducible, precise, and accurate.

Quality control. The system of close examination of the critical details of

an analytical procedure in order to have the proper equipment parameters, techniques, supplies and reagents to achieve a predetermined level of quality data, with the performance of a particular laboratory analysis.

Secretary. The Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his or her stead.

Service. The Agricultural Marketing Service of the United States Department of Agriculture.

[58 FR 42414, Aug. 9, 1993, as amended at 61 FR 51350, Oct. 2, 1996]

analysis for a commodity and its related products;

(2) A review of the laboratory methodologies and procedures;

(3) A review of records for the calibration and maintenance of equipment; (4) A review of records documenting sample handling;

(5) The evidence of quality control records;

(6) The evidence of correct reporting and determination of analytical data.

(b) A laboratory will receive a quality assurance report following the review. This evaluation will address any necessary improvements to the laboratory program(s) being examined.

§ 90.103 Maintenance of quality control records.

Quality control records pertaining, but not limited to the following areas, shall be retained by the laboratory for at least the 3 most recent years:

(a) Prepared solution standardizations;

(b) Recovery studies by by known analyte additions;

(c) The purity checks of reagents and test materials;

(d) Apparatus and equipment calibrations;

(e) The quality examination and testing of materials;

(f) The mandatory participation in proficiency check sample testing or collaborative studies;

(g) Daily critical parameter checks of equipment, such as temperature readings;

(h) The equivalency tests of new procedures with standard methodologies.

91.28 Issuance of corrected certificates or amendments for analysis reports. 91.29 Issuance of duplicate certificates or reissuance of an analysis report. 91.30 Maintenance and retention of copies of certificates or analysis reports.

Subpart H-Appeal of Laboratory Services 91.31 When an appeal of a laboratory service may be requested.

91.32 Where to file for an appeal of a laboratory service and information required. 91.33 When an application for an appeal of a laboratory service may be withdrawn. 91.34 When an appeal of a laboratory service

may be refused.

91.35 Who shall perform an appealed laboratory service.

91.36 Appeal laboratory certificate.

Subpart 1-Fees and Charges

91.37 Fees for laboratory testing, analysis, and other services.

91.38 Additional fees for appeal of analysis. 91.39 Special request fees for overtime and legal holiday service.

Words used in the regulations in this part in the singular form will import the plural, and vice versa, as the case may demand. As used throughout the regulations in this part, unless the context requires otherwise, the following terms will be construed to mean:

Analyses. Microbiological, chemical, or physical tests performed on a commodity.

Applicant. Any person who requests services provided by the Division.

Legal holidays. Those days designated as legal public holidays specified by Congress in paragraph (a) of section 6103, title 5 of the United States Code and any other day declared to be a holiday by Federal Statute or Executive Order. Under section 6103 and Executive Order 10357, as amended, if the specified legal public holiday falls on a Saturday, the preceding Friday shall be considered the holiday, or if the specified legal holiday falls on a Sunday, the following Monday shall be considered to be the holiday.

§91.3 Authority.

The Division Director is charged with the administration of this subchapter.

Subpart B-General Services

§ 91.4 Kinds of services.

(a) Analytical tests. Analytical laboratory testing services under the regulations consist of microbiological, chemical, and certain other analyses, requested by the applicant and performed on tobacco, seed, dairy, egg, fruit and vegetable, meat and poultry, and related processed products. Analyses are performed to determine if products meet Federal specifications or specifications defined in purchase contracts and cooperative agreements. Analyses are also performed on egg products as part of the mandatory Egg Products Inspection Program.

(b) Examination and licensure. The Division administers examinations and issues licenses to chemists to certify the grade of cottonseed.

(c) Quality assurance reviews. The Division performs on-site laboratory quality assurance reviews (both required and voluntary) to ensure that appropriate technical methods, equipment maintenance, and quality control procedures are being observed.

(d) Consultation. Technical advice, statistical science consultation, and quality assurance program assistance are provided by the Division for domestic and foreign laboratories.

§ 91.5 Where services are offered.

(a) Services are offered to applicants at the Science and Technology Division laboratories and facilities as listed below.

(1) Science and Technology Division regional laboratories. A variety of tests and laboratory analyses are available in two regional multi-disciplinary Science and Technology Division (S&TD) laboratories, and are located as follows:

(i) USDA, AMS, S&TD, Midwestern Laboratory, 3570 North Avondale Avenue, Chicago, IL 60618.

(ii) USDA, AMS, S&TD, Eastern Laboratory, 2311-B Aberdeen Boulevard, Gastonia, NC 28054.

(2) Science and Technology Division aflatoxin laboratories. The specialty laboratories performing aflatoxin testing on peanuts, peanut products, tree nuts and other commodities are located as follows:

(1) USDA, AMS, S&TD, 1557 Reeves Street, Mail: P.O. Box 1368, Dothan, AL 36302.

(ii) USDA, AMS, S&TD, c/o Golden Peanut Company, 200 West Washington Street, Mail: P.O. Box 488, Ashburn, GA 31714.

(iii) USDA, AMS, S&TD, 1211 Schley Avenue, Albany, GA 31707.

(iv) USDA, AMS, S&TD, c/o Golden Peanut Company, 301 West Pearl Street, Mail: P.O. Box 279, Aulander, NC 27805.

(v) USDA, AMS, S&TD, 610 North Main Street, Blakely, GA 31723. (vi) USDA, AMS, S&TD, 107 South Fourth Street, Madill, OK 73446. (vii) USDA, AMS, S&TD, c/o Steven Industries, Cargill, Inc., 715 North Main Street, Mail: P.O. Box 272, Dawson, GA 31742.

(viii) USDA, AMS, S&TD, 308 Culloden Street, Mail: P.O. Box 1130, Suffolk, VA 23434.

(3) Citrus laboratory. The Science and Technology Division Citrus Laboratory specializes in testing citrus juices and other citrus products and is located as follows: Science and Technology Division Citrus Laboratory, 98 Third Street, SW, Winter Haven, FL 33880.

(4) Divisional laboratories. Laboratory services are available in all areas covered by cooperative agreements providing for this laboratory work and entered on behalf of the Department with cooperating Federal or State laboratory agencies pursuant to authority contained in Act(s) of Congress. Also, services may be provided in other areas not covered by a cooperative agreement if the Administrator determines that it is possible to provide laboratory services.

(5) Other alternative laboratories. Laboratory analyses may be conducted at alternative Science and Technology Division laboratories and can be reached from any commodity market in which a laboratory facility is located to the extent laboratory personnel is available.

(6) The Plant Variety Protection (PVP) Office. The PVP office and plant examination facility of the Science and Technology Division issues certificates of protection to developers of novel varieties of plants which reproduce sexually and is located as follows: USDA, AMS, Science and Technology Division, Plant Variety Protection Office, Room 500 National Agricultural Library Building, Beltsville, MD 20705.

(7) Science and Technology Division headquarters offices. The examination, licensure, quality assurance reviews, and consultation services are provided by headquarters staff located in Washington, DC.

(8) Statistical Branch offices. Statistical Science services are provided by Science and Technology Division (S&TD) offices located as follows: (i) USDA, AMS, Science and Technology Division, Statistical Branch, Kansas City Technical Center, 10383 No. Executive Hills Blvd., Kansas City, MO 64153.

(ii) USDA, AMS, S&TD, Statistical Branch, 0611 So. Agriculture Bldg., 14th & Independence Avenue, SW., Washington, DC 20250.

(9) Residue Branch offices. Services afforded by the Recordkeeping Program for restricted use pesticides by certified applicators and services afforded by the Pesticide Data Program are provided by offices located as follows: (i) USDA, AMS, Science and Technology Division, 8700 Centreville Rd., suite 200, Manassas, VA 22110.

(ii) USDA, AMS, Science and Technology Division, Office of Director, 3507 So. Agriculture Bldg., 14th & Independence Avenue, SW., Washington, DC 20250.

(b) The addresses of the various laboratories and offices appear in the pertinent parts of this subchapter. A prospective applicant may obtain a current listing of addresses and telephone numbers of Science and Technology Division laboratories, offices, and facilities by addressing an inquiry to the Director, Science and Technology Division, Agricultural Marketing Service,