Words in the regulations in this part in the singular form shall be deemed to import the plural and vice versa, as the case may demand. For the purposes of the regulations in this part, unless the context otherwise requires, the following terms shall have the following meanings:

Acceptance number. “Acceptance number” means the number in a sampling plan that indicates the maximum number of deviants permitted in a sample of a lot that meets a specific requirement.

Act. “Act” means the applicable provisions of the Agricultural Marketing Act of 1946 (60 Stat. 1087 et seq., as amended; 7 U.S.C. 1621 et seq.), or any other act of Congress conferring like authority.

Administrator. “Administrator” means the Administrator of the Agricultural Marketing Service.

Applicant. “Applicant” means any interested party who requests inspection service under the regulations in this part.

Approved plant. See “Plant, approved”.

Case. “Case” means the number of containers (cased or uncased) which, by the particular industry are ordinarily packed in a shipping container.

Case or shipping case. “Case” or “shipping case” means a unit consisting of a given number of primary containers of the same size, the number and arrangement per unit conforming to customary trade practice. For products not physically assembled into a shipping case (i.e. stacked bright) case means simulating the containers in such lot into a unit consisting of the same number of primary containers corresponding to customary trade practice (or corresponding to the unit as defined above).

Certificate of loading. Certificate of loading means a statement, either written or printed, issued pursuant to the regulations in this part, relative to checkloading of a processed product subsequent to inspection thereof. The certificate of loading may be issued in lieu of an official inspection certificate when the same inspection procedures are applied and when authorized by the Administrator.

Certificate of sampling. “Certificate of sampling” means a statement, either written or printed issued pursuant to the regulations in this part, identifying officially drawn samples and may include a description of condition of containers and the condition under which the processed product is stored.

Class. See “Grade.”

Condition. “Condition” means the degree of soundness of the product which may affect its merchantability and includes, but is not limited to those factors which are subject to change as a result of age, improper preparation and processing, improper packaging, improper storage or improper handling.

Department. “Department” means the United States Department of Agriculture.

Deviant. “Deviant” means a sample unit affected by one or more deviations or a sample unit that varies in a specifically defined manner from the requirements of a standard, specification, or other inspection document.

Deviation. “Deviation” means any specifically defined variation from a particular requirement.

Grade or class. “Grade” or “class” designates a level or rank of quality.

Grader. See “Inspector”.

Inspection certificate. “Inspection certificate” means a statement, either written or printed, issued pursuant to the regulations in this part, setting forth in addition to appropriate descriptive information relative to a processed product, and the container thereof, the quality and condition, or any part thereof, of the product and may include a description of the conditions under which the product is stored.

Inspection service. (See Inspection service, general below.)

Inspection service, general:

(a) The sampling pursuant to the regulations in this part;

(b) The determination pursuant to the regulations in this part of:

(1) Essential characteristics such as style, type, size, sirup density or identity of any processed product which differentiates between major groups of the same kind;

(2) The class, quality and condition of any processed product, including the condition of the container thereof by the examination of appropriate samples;

(c) The issuance of any certificate of sampling, inspection certificates, or certificates of loading of a processed product, or any report relative to any of the foregoing; or

(d) Performance by an inspector of any related services such as observing the preparation of the product from its raw state through each step in the entire process; observing conditions under which the product is prepared, processed, and packed; or observing plant sanitation as a prerequisite to the inspection of the processed product, either on a continuous or periodic basis, or checkloading the inspected processed product in connection with the distribution or marketing thereof.

Inspection Service; types of. (a) Lot inspection means the inspection and grading of specific lots of processed fruits and vegetables which are located in plant warehouses, commercial storage, railway cars, trucks, or any other conveyance or storage facility.

(b) Approved plant-lot inspection means the inspection and grading of specific lots of processed fruits and vegetables which are located in plant warehouses, commercial storage, railway cars, trucks, or any other conveyance or storage facility. However, under “approved plant-lot inspection”, the inspection service has knowledge that the products were processed or packaged in plants meeting the “plant approved” definition. This means that the plant facilities, sanitation, and methods of operation have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate for inspection or grading service in accordance with § 52.81 through § 52.83 of this part.

(c) Continuous inspection is the conduct of inspection and grading services in an approved plant whereby one or more inspector(s) are present at all times the plant is in operation to make in-process checks on the preparation, processing, packing, and warehousing of all products under contract and to assure compliance with sanitary requirements.

(d) Pack certification is the conduct of inspection and grading services in an approved plant whereby one or more inspector(s) may make inspection of the preparation and processing of products under contract, but are not required to be present at all times the plant is in operation.

(1) Under a Designated Lot-contract, inspector(s) will grade and certify only those lots designated by the applicant.

(2) Under a Quality Assurance contract, inspector(s) will use information available from the applicant's quality control records to certify lots, as requested, and will grade lots at random as often as necessary to verify the reliability of the applicant's quality control system.

Inspector or grader. “Inspector” or “grader” means any employee of the Department authorized by the Secretary or any other person licensed by the Secretary to investigate, sample, inspect, and certify in accordance with the regulations in this part to any interested party the class, quality and condition of processed products covered in this part and to perform related duties in connection with the inspection service.

Inspector in charge. “Inspector in Charge” means any inspector designated on a plant working shift or in a field office laboratory as the inspector in charge of the inspection work when authorized by the Administrator to act in that capacity.

Inspector, subordinate. “Subordinate inspector” means any inspector assigned to a plant or field office to work under the direction of an inspector-in-charge.

Inspector's aide. “Inspector's aide” means any employee of the Department authorized to perform a limited number and type of duties under the close supervision of an inspector.

Interested party. “Interested party” means any person who has a financial interest in the commodity involved.

Licensed sampler. “Licensed sampler” means any person who is authorized by the Secretary to draw samples of processed products for inspection service, to inspect for identification and condition of containers in a lot, and may, when authorized by the Administrator, perform related services under the act and the regulations in this part.

Lot. Lot means any number of containers of the same size and type which contain a processed product of the same type and style located in the same warehouse or conveyance, and which is available for inspection service at any time: Provided, that the number of containers comprising lot may not exceed the maximum number specified in the sampling plans in § 52.38 of this Subpart: And further provided that:

(a) If the applicant requests a separate inspection certificate covering a specific portion of a lot, such portion must be separately marked or otherwise identified in such a manner as to permit sampling, inspection, and certification of such portion as a separate lot; and

(b) Under in-plant (in-process) inspection, the inspector is authorized to limit the number of containers of a processed product that may be included in a lot to a period of consecutive production equivalent to one production shift with a maximum of 24 hours of consecutive production.

Officially drawn sample. “Officially drawn sample” means any sample that has been selected from a particular lot by an inspector, licensed sampler, or by any other person authorized by the Administrator pursuant to the regulations in this part.

Other processed food products. Among such other processed food products are the following: Honey; molasses, except for stockfeed; nuts and nut products, except oil; sugar (cane, beet, and maple); sirups (blended), sirups, except from grain; tea; cocoa; coffee; spices; condiments.

Person. “Person” means any individual, partnership, association, business trust, corporation, any organized group of persons (whether incorporated or not), the United States (including, but not limited to, any corporate agencies thereof), any State, county, or municipal government, any common carrier, and any authorized agent of any of the foregoing.

Plant. “Plant” means the premises, buildings, structure, and equipment (including, but not being limited to machines, utensils, vehicles, and fixtures located in or about the premises) used or employed in the preparation, processing, handling, transporting and storage of fruits and vegetables, or the processed products thereof.

Plant, approved. “Approved plant” means any plant in which the facilities, sanitation, and methods of operation have been surveyed and approved for specific product(s) by the Administrator as suitable and adequate for inspection or grading service in accordance with §§ 52.81 through 52.83.

Processed product. “Processed product” means any fruit, vegetable, or other food product covered under the regulations in this part which has been preserved by any recognized commercial process, including, but not limited to canning, freezing, dehydrating, drying, the addition of chemical substances, or by fermentation.

Quality. “Quality” means the inherent properties of any processed product which determine the relative degree of excellence of such product, and includes the effects of preparation and processing, and may or may not include the effects of packing media, or added ingredients.

Rejection number. “Rejection number” means the number in a sampling plan that indicates the minimum number of deviants in a sample that will cause a lot to fail a specific requirement.

Sample. “Sample” means any number of sample units to be used for inspection.

Sample unit. “Sample unit” means a container and/or its entire contents, a portion of the contents of one or more containers or other unit of commodity, or a composite mixture of a product used for inspection.

Sampling. “Sampling” means the act of selecting samples of processed products for the purpose of inspection under the regulations in this part.

Secretary. “Secretary” means the Secretary of the Department or any other officer or employee of the Department authorized to exercise the powers and to perform the duties of the Secretary in respect to the matters covered by the regulations in this part.

Shipping container. “Shipping container” means an individual container designed for shipping a number of packages or cans ordinarily packed in a container for shipping or designed for packing unpackaged processed products for shipping.

Unofficial sample. Unofficial sample means any sample that has been selected by any person other than an inspector or licensed sampler, or by any other person not authorized by the Administrator pursuant to the regulations in this part.

Subsection 203(h) of the Agricultural Marketing Act of 1946, as amended by Pub. L. 272, 84th Congress, provides criminal penalties for various specified offenses relating to official certificates, memoranda, marks or other identifications, and devices for making such marks or identifications, issued or authorized under section 203 of said act, and certain misrepresentations concerning the inspection or grading of agricultural products under said section. For the purposes of said subsection and the provisions in this part, the terms listed below shall have the respective meanings specified:

Official certificate. “Official certificate” means any form of certification, either written or printed, including those defined in § 52.2, used under this part to certify with respect to the inspection, class, grade, quality, size, quantity, or condition of products (including the compliance of products with applicable specifications).

Official device. “Official device” means a stamping appliance, branding device, stencil, printed label, or any other mechanically or manually operated tool that is approved by the Administrator for the purpose of applying any official mark or other identification to any product or the packaging material thereof; or any device approved and designated by the Administrator as a USDA official device for use as a color standard, defect guide, or other similar aid to interpret the United States Department of Agriculture grade standards and to facilitate conduct of the inspection service.

Official identification. “Official identification” means any United States (U.S.) standard designation of class, grade, quality, size, quantity, or condition specified in this part or any symbol, stamp, label, or seal indicating that the product has been graded or inspected and/or indicating the class, grade, quality, size, quantity, or condition of the product approved by the Administrator and authorized to be affixed to any product, or affixed to or printed on the packaging material of any product.

Official mark. “Official mark” means the grade mark, inspection mark, combined form of inspection and grade mark, and any other mark, or any variations in such marks, including those prescribed in § 52.53 approved by the Administrator and authorized to be affixed to any product, or affixed to or printed on the packaging material of any product, stating that the product was graded or inspected or both, or indicating the appropriate U.S. Grade or condition of the product, or for the purpose of maintaining the identity of products graded or inspected or both under this part.

Official memorandum. “Official memorandum” means any initial record of findings made by an authorized person in the process of grading, inspecting, or sampling pursuant to this part, any processing or plant-operation report made by an authorized person in connection with grading, inspecting, or sampling under this part, and any report made by an authorized person of services performed pursuant to this part.

(a) The Administrator, Agricultural Marketing Service, United States Department of Agriculture is charged with the administration of the regulations in this part except that he may delegate any or all of such functions to any officer or employee of the Agricultural Marketing Service of the Department, in his discretion.

(b) All services provided under the regulations of this part, including the hiring and licensing of inspection, grading, and sampling personnel shall be conducted without discrimination because of race, color, sex, religion, or national origin.

Inspection service may be furnished wherever any inspector or licensed sampler is available and the facilities and conditions are satisfactory for the conduct of such service.

An application for inspection service may be made by any interested party, including, but not limited to, the United States and any instrumentality or agency thereof, any State, county, municipality, or common carrier, and any authorized agent in behalf of the foregoing.

An application for inspection service may be made to the office of inspection or to any inspector, at or nearest the place where the service is desired. An up-to-date list of the Inspection Field Offices of the Department may be obtained upon request to the Administrator. Satisfactory proof that the applicant is an interested party shall be furnished.

(a) Application for inspection service shall be made in the English language and may be made orally (in person or by telephone), in writing, or electronically. If an application for inspection is made orally, written confirmation may be required by the inspection service involved.

(b) In connection with each application for inspection service, there shall be furnished such information as may be necessary to perform an inspection on the processed product(s), including but not limited to, the name of the product, name and address of the packer or plant where such product was packed, the location of the product, its lot or car number, codes or other identification marks, the number of containers, the type and size of the containers, the interest of the applicant in the product, whether the lot has been inspected previous to the application by any Federal agency and the purpose for which inspection is desired.

An application for inspection service shall be regarded as filed only when made in accordance with the regulations in this part.

A record showing the date when each application for inspection or for an appeal inspection is received shall be maintained.

An application for inspection service may be rejected by the Administrator (a) for non-compliance by the applicant with the regulations in this part, (b) for non-payment for previous inspection services rendered, (c) when the product is not properly identifiable by code or other marks, or (d) when it appears that to perform the inspection service would not be to the best interests of the Government. Such applicant shall be promptly notified of the reason for such rejection.

An application for inspection service may be withdrawn by the applicant at any time before the inspection is performed: Provided, That, the applicant shall pay at the hourly rate prescribed in § 52.42 for the time incurred by the inspector in connection with such application, any travel expenses, telephone, telegraph or other expenses which have been incurred by the inspection service in connection with such application.

Any sample of a processed product that has been used for inspection may be returned to the applicant, at his request and expense; otherwise it shall be destroyed, or disposed of to a charitable institution.

(a) Inspection service shall be performed on the basis of the appropriate United States standards for grades of processed products, Federal, Military, Veterans Administration or other government agency specifications, written contract specifications, or any written specification or instruction which is approved by the Administrator.

(b) Unless otherwise approved by the Administrator, compliance with such grade standards, specifications, or instructions shall be determined by evaluating the product, or sample, in accordance with the requirements of such standards, specifications or instructions: Provided, That when inspection for quality is based on any U.S. grade standard which contains a scoring system, the grade to be assigned to a lot is the grade indicated by the average of the total of the scores of the respective sample units: Provided further, That—

(1) Such sample complies with the applicable standards of quality promulgated under the Federal Food, Drug, and Cosmetic Act;

(2) Such sample complies with the product description;

(3) Such sample meets the indicated grade with respect to factors of quality which are not rated by score points; and

(4) With respect to those factors of quality which are rated by score points, each of the following requirements is met:

(i) None of the sample units falls more than one grade below the indicated grade because of any quality factor to which a limiting rule applies;

(ii) None of the sample units falls more than 4 score points below the minimum total score for the indicated grade;

(iii) The number of deviants does not exceed the applicable acceptance number indicated in the sampling plans contained in § 52.38 (“deviants”, as used in this paragraph, means sample units that fall into the next grade below the indicated grade but do not score more than 4 points below the minimum total score for the indicated grade);

(5) If any of the provisions contained in paragraphs (b) (3) and (4) of this section are not met, the grade is determined by considering such provisions in connection with succeedingly lower grades until the grade of the lot, if assignable, is established; and

(6) When it is determined that a portion of a lot bearing a particular identification mark is of lower quality or deficient in other factors, the grade or compliance of the lot shall be no higher than that of the portion bearing the particular identification mark.

Inspection service shall be performed, insofar as practicable, in the order in which applications therefor are made except that precedence may be given to any such applications which are made by the United States (including, but not being limited to, any instrumentality or agency thereof) and to any application for an appeal inspection.

If the inspector determines that it is not possible to accurately ascertain the quality or condition of a processed product immediately after processing because the product has not reached equilibrium in color, sirup density, or drained weight, or for any other substantial reason, he may postpone inspection service for such period as may be necessary.

No inspector shall inspect any processed product in which he is directly or indirectly financially interested.

Inspection certificates, certificates of sampling or loading, and other memoranda concerning inspection service shall be issued on forms approved by the Administrator.

(a)(1) The person signing and issuing the certificate shall be one of the following:

(i) The inspector who performed the inspection.

(ii) Another employee of the Inspection Service who has been authorized by the Administrator to act in a supervisory capacity.

(iii) An inspector designated as the “inspector in charge,” when the certificate represents composite inspection of several persons.

(2) In all cases the inspection certificate shall be prepared in accordance with the facts set forth in the official memoranda made by the inspector or inspectors in connection with the inspection. Whenever a certificate is signed by an inspector in charge, that title must appear in connection with the signature.

(b) A certificate of loading shall be issued and signed by the inspector or licensed sampler authorized to check the loading of a specific lot of processed products: Provided, That, another employee of the inspection service authorized by the Administrator to act in a supervisory capacity or designated as the “inspector in charge,” may sign such certificate of loading covering any processed product checkloaded by an inspector or licensed sampler and authorized by the Administrator to affix the inspector's or licensed sampler's signature to a certificate of loading which has been prepared in accordance with the facts set forth in the notes made by the inspector or licensed sampler in connection with the checkloading of a specific lot of processed products.

A corrected inspection certificate may be issued by the inspector who issued the original certificate after distribution of a certificate if errors, such as incorrect dates, code marks, grade statements, lot or car numbers, container sizes, net or drained weights, quantities, or errors in any other pertinent information require the issuance of a corrected certificate. Whenever a corrected certificate is issued, such certificate shall supersede the inspection certificate which was issued in error and the superseded certificate shall become null and void after the issuance of the corrected certificate.

A letter report in lieu of an inspection certificate may be issued by an inspector when such action appears to be more suitable than an inspection certificate: Provided, That, the issuance of such report is approved by the Administrator.

The original of any inspection certificate, issued under the regulations in this part, and not to exceed four copies thereof, if requested prior to issuance, shall be delivered or mailed promptly to the applicant, or person designated by the applicant. All other copies shall be filed in such manner as the Administrator may designate. Additional copies of any such certificates may be supplied to any interested party as provided in § 52.49.

Upon request of any interested party, the results of an inspection may be telegraphed or telephoned to him, or to any other person designated by him, at his expense.

An application for an appeal inspection may be made by any interested party who is dissatisfied with the results of an inspection as stated in an inspection certificate, if the lot of processed products can be positively identified by the inspection service as the lot from which officially drawn samples were previously inspected. Such application shall be made within thirty (30) days following the day on which the previous inspection was performed, except upon approval by the Administrator the time within which an application for appeal inspection may be made may be extended.

(a) Application for an appeal inspection may be filed with:

(1) The supervisor in the office that issued the inspection certificate on which the appeal covering the processed product is requested; or

(2) The inspector in charge of the office of inspection at or nearest the place where the processed product is located.

(b) The application for appeal inspection shall state the location of the lot of processed products and the reasons for the appeal; and date and serial number of the certificate covering inspection of the processed product on which the appeal is requested, and such application may be accompanied by a copy of the previous inspection certificate and any other information that may facilitate inspection. Such application may be made orally (in person or by telephone), in writing, or by telegraph. If made orally, written confirmation shall be made promptly.

An application for appeal inspection may be withdrawn by the applicant at any time before the appeal inspection is performed: Provided, That, the applicant shall pay at the hourly rate prescribed in § 52.42, for the time incurred by the inspector in connection with such application, any travel expenses, telephone, telegraph, or other expenses which have been incurred by the inspection service in connection with such application.

An application for an appeal inspection may be refused if:

(a) The reasons for the appeal inspection are frivolous or not substantial;

(b) The quality or condition of the processed product has undergone a material change since the inspection covering the processed product on which the appeal inspection is requested;

(c) The lot in question is not, or cannot be made accessible for the selection of officially drawn samples;

(d) The lot relative to which appeal inspection is requested cannot be positively identified by the inspector as the lot from which officially drawn samples were previously inspected; or

(e) There is noncompliance with the regulations in this part. Such applicant shall be notified promptly of the reason for such refusal.

An appeal inspection shall be performed by an inspector or inspectors (other than the one from whose inspection the appeal is requested) authorized for this purpose by the Administrator and, whenever practical, such appeal inspection shall be conducted jointly by two such inspectors: Provided, That, the inspector who made the inspection on which the appeal is requested may be authorized to draw the samples when another inspector or licensed sampler is not available in the area where the product is located.

After an appeal inspection has been completed, the lot(s) cannot be further appealed unless authorized by the Administrator. An appeal inspection certificate shall be issued, showing the results of such appeal inspection; and such certificate shall supersede the inspection certificate previously issued for the processed product involved. Each appeal inspection certificate shall clearly identify the number and date of the inspection certificate which it supersedes. The superseded certificate shall become null and void upon the issuance of the appeal inspection certificate and shall no longer represent the quality or condition of the processed product described therein. The inspector or inspectors issuing an appeal inspection certificate shall forward notice of such issuance to such persons as he considers necessary to prevent misuse of the superseded certificate if the original and all copies of such superseded certificate have not previously been delivered to the inspector or inspectors issuing the appeal inspection certificate. The provisions in the regulations in this part concerning forms and certificates, issuance of certificates, and disposition of certificates shall apply to appeal inspection certificates, except that copies of such appeal inspection certificates shall be furnished to all interested parties who received copies of the superseded certificate.

Any person deemed to have the necessary qualifications may be licensed as a licensed sampler to draw samples for the purpose of inspection under the regulations in this part. Such a license shall bear the printed signature of the Secretary, and shall be countersigned by an authorized employee of the Department. Licensed samplers shall have no authority to inspect processed products under the regulations in this part except as to identification and condition of the containers in a lot. A licensed sampler shall perform his duties pursuant to the regulations in this part as directed by the Administrator.

Application to become a licensed sampler shall be made to the Administrator on forms furnished for that purpose. Each such application shall be signed by the applicant in his own handwriting, and the information contained therein shall be certified by him to be true, complete, and correct to the best of his knowledge and belief, and the application shall contain or be accompanied by:

(a) A statement showing his present and previous occupations, together with names of all employers for whom he has worked, with periods of service, during the ten years previous to the date of his application;

(b) A statement that, in his capacity as a licensed sampler, he will not draw samples from any lot of processed products with respect to which he or his employer is an interested party;

(c) A statement that he agrees to comply with all terms and conditions of the regulations in this part relating to duties of licensed samplers; and

(d) Such other information as may be requested.

Inspections will ordinarily be performed by employees under the Administrator who are employed as Federal Government employees for that purpose. However, any person employed under any joint Federal-State inspection service arrangement may be licensed, if otherwise qualified, by the Secretary to make inspections in accordance with this part on such processed products as may be specified in his license. Such license shall be issued only in a case where the Administrator is satisfied that the particular person is qualified to perform adequately the inspection service for which such person is to be licensed. Each such license shall bear the printed signature of the Secretary and shall be countersigned by an authorized employee of the Department. An inspector shall perform his duties pursuant to the regulations in this part as directed by the Administrator.

Pending final action by the Secretary, the Administrator may, whenever he deems such action necessary, suspend the license of any licensed sampler, or licensed inspector, issued pursuant to the regulations in this part, by giving notice of such suspension to the respective licensee, accompanied by a statement of the reasons therefor. Within seven days after the receipt of the aforesaid notice and statement of reasons by such licensee, he may file an appeal, in writing, with the Secretary supported by any argument or evidence that he may wish to offer as to why his license should not be suspended or revoked. After the expiration of the aforesaid seven days period and consideration of such argument and evidence, the Secretary shall take such action as he deems appropriate with respect to such suspension or revocation.

Upon termination of his services as a licensed sampler or licensed inspector, or suspension or revocation of his license, such licensee shall surrender his license immediately to the office of inspection serving the area in which he is located. These same provisions shall apply in a case of an expired license.

An inspector or a licensed sampler shall select samples, upon request, from designated lots of processed products which are so placed as to permit thorough and proper sampling in accordance with the regulations in this part. Such person shall, unless otherwise directed by the Administrator, select sample units of such products at random, and from various locations in each lot in such manner and number, not inconsistent with the regulations in this part, as to secure a representative sample of the lot. Samples drawn for inspection shall be furnished by the applicant at no cost to the Department.

Each applicant shall cause the processed products for which inspection is requested to be made accessible for proper sampling. Failure to make any lot accessible for proper sampling shall be sufficient cause for postponing inspection service until such time as such lot is made accessible for proper sampling.

Officially drawn samples shall be marked by the inspector or licensed sampler so such samples can be properly identified for inspection.

Unless otherwise directed by the Administrator, samples which are to be shipped to any office of inspection shall be forwarded to the office of inspection serving the area in which the processed products from which the samples were drawn is located. Such samples shall be shipped in a manner to avoid any material change in the quality or condition of the sample of the processed product. Containers shall be identified and properly sealed with tape. A facsimile of the “Officially Sampled” stamp shall be placed over the taped container. All transportation charges in connection with such shipments of samples shall be at the expense of the applicant.

(a) Except as otherwise provided for in this section in connection with in-plant inspection and unless otherwise approved by the Administrator, samples shall be selected from each lot in the exact number of sample units indicated for the lot size in the applicable sampling plans. The lot size is to correspond to a sample size with a maximum of 29 sample units: Provided, that at the discretion of the inspection service, the number of sample units selected may be increased to the exact number of sample units indicated for any one of the larger sample sizes provided for in the appropriate plans. The samples size may be increased beyond 29 sample units in accordance with the following sampling plan:

(b) Under the sampling plans with respect to any specified requirement:

(1) If the number of deviants (as defined in connection with the specific requirement) in the sample does not exceed the acceptance number prescribed for the sample size, the lot meets the requirement;

(2) If the number of deviants (as defined in connection with the specific requirement) in the sample exceeds the acceptance number prescribed for the sample size, the lot fails the requirement.

(c) If in the conduct of on-line in-plant inspection of a product covered by a grade standard which does not contain sampling plans, the sample is examined before the lot size is known and the number of sample units exceeds the prescribed sample size for such lot, but does not equal any of the prescribed larger sample sizes, the lot may be deemed to meet or fail a specific requirement in accordance with the following procedure:

(1) If the number of deviants (as defined in connection with the specific requirement) in the nonprescribed sample does not exceed the acceptance number of the next smaller sample size, the lot meets the requirement;

(2) If the number of deviants (as defined in connection with the specific requirement) in the nonprescribed sample equals the acceptance number prescribed for the next larger sample size, additional sample units shall be selected to increase the sample to the next larger prescribed sample size;

(3) If the number of deviants (as defined in connection with the specific requirement) in the nonprescribed sample exceeds the acceptance number prescribed for the next larger sample size, the lot fails the requirement.

(d) In the conduct of on-line in-plant inspection, sampling may be performed on a time interval basis. The sampling frequency shall be specified in an applicable grade standard or other procedural instruction approved by the Administrator.

(e) In the event that the lot compliance determination provisions of a standard or specification are based on the number of specified deviations instead of deviants the procedures set forth in this section may be applied by substituting the word “deviation” for the word “deviant” wherever it appears.

(f) Sampling plans referred to in this section are those contained in Tables I, II, III, IV, and V and (g)(1) and (g)(2) of this section which follow or any other plans which are applicable. For processed products not included in these tables, the minimum sample size shall be the exact number of sample units prescribed in the table, container group, and lot size that, as determined by the inspector, most closely resembles the product, type, container, size and amount of product to be sampled. The maximum sample size in tables I, II, III, IV, V, (g)(1), (g)(2) and processed products not included in these tables is 29 sample units.

(g)(1) Sampling plan for dried figs. For each 10,000 pounds (or fraction of 10,000 pounds) of product—6 sample units of approximately 35 figs each accumulated into 1 composite (at least 200 figs). Each composite will be examined separately, and all must meet the requirement for the U.S. Grade.

(2) Sampling plan for dried fruits other than dates and figs. For each 15,000 pounds (or fraction of 15,000 pounds) of product—sample units of approximately 16 ounces each accumulated into 1 composite (at least 100 ounces) Each composite will be examined separately and all must meet the requirements for the U.S. Grade.

(a) Terms applicable to both on-line inspection and lot inspection.

(1) Acceptable Quality Level (AQL). The maximum percent of defective units of product or the maximum number of defects per hundred units of product which are acceptable as a process average. At the AQL's contained in the statistical sampling plans of this subpart, production has a probability of acceptance (“Pa”) of approximately 95 percent.

(2) Acceptance sampling. Sampling inspection in which decisions are made to accept or reject product.

(3) Attributes. A method of measurement whereby units of product are examined for the presence or absence of specified characteristics in each unit in the sample.

(4) Defect. Any nonconformance of a unit of product from specified requirements of a single quality characteristic. Defects are classed as “minor,” “major,” “severe” or “critical” depending upon the severity and undesirability of the defect.

(5) Defective. A unit of product that has one or more defects.

(6) Inspection by attributes. Inspection whereby a unit of product is classified as defective or nondefective or the number or defects in the unit of product is counted.

(7) Standard sample unit size. A specified amount of product to be used for inspection.

(b) Terms applicable to on-line inspection only.

(1) Basic inspection period. A specified period of consecutive production designated for on-line inspection.

(2) Cumulative Sum Sampling (CuSum) Plan. An on-line sampling plan that accumulates the number of defects (or defectives), which exceed the sample unit tolerance (“T”), in a series of consecutive samples. Terms specific to the CuSum sampling plan are:

(i) Acceptance limit (“L”). The maximum accumulation of defects (or defectives) allowed to exceed the sample unit tolerance (“T”) in any sample unit or consecutive group of sample units.

(ii) CuSum value. The accumulated number of defects (or defectives) that exceed the sample unit tolerance (“T”).

(iii) Sample unit tolerance (“T”). The allowable number of defects (or defectives) in any sample unit.

(iv) Starting value (“S”). The initial CuSum value used to begin a CuSum sampling plan.

(3) On-line sampling inspection. The random selection and subsequent inspection of sample units from a production line.

(4) Probability of acceptance (“Pa”). The probability that a portion of production, with a given level of quality, will be accepted. In on-line sampling inspection, the probability of acceptance of any portion of production depends on the sample results obtained from the preceding portions. The probability of acceptance values associated with these procedures are the values which would be expected if a large number of sample units are to be inspected. For the CuSum plans referenced in these procedures, the probability of acceptance at the Acceptable Quality Level (AQL) is approximately 95 percent. The starting value (“S”) associated with each CuSum plan helps to make the probability of acceptance of the first portions of production of a basic inspection period as close as possible to 95 percent.

(c) Terms applicable to lot inspection only.

(1) Acceptance number. The largest number of defects (or defectives) in the sample that will permit acceptance of the inspection lot.

(2) Inspection lot. Any number of containers of the same size and type which contain a processed product of the same type and style, manufactured or processed under essentially the same conditions, offered for inspection and acceptance at one time.

(3) Probability of acceptance (“Pa”). The probability that an inspection lot, with a given level of quality, will be accepted.

(a) General. The Cumulative Sum Sampling Plan, hereinafter referred to as “CuSum,” shall be used as the on-line sampling plan for attributes standards under the following conditions.

(1) The producer has designated the intended grade for the basic inspection period prior to the start of production.

(2) Inspection of the product shall be made during the basic inspection period at a point after which all product characteristics, subject to inspection, are fixed and will not be subject to change during final packaging.

(3) A shift to CuSum sampling plans from lot sampling plans during a basic inspection period is not permitted (or vice versa).

(b) Sampling rate/frequency. The minimum number of standard sample units to be drawn at random shall be determined by the applicable sampling procedure as approved by the Administrator.

(c) Determining CuSum values. At the beginning of the basic inspection period, the CuSum value is set equal to the starting value (“S”) for the specified CuSum plan. The CuSum value is then determined for each consecutive sample unit as follows:

(1) Add the number of defects (or defectives) for the present sample unit to the CuSum value of the previous sample unit.

(2) Subtract the sample unit tolerance (“T”).

(3) The CuSum value is reset in the following situations. However, determine compliance with the designated grade (see paragraph (d) of this section) prior to resetting the CuSum value:

(i) Reset the CuSum value to zero (0) if the CuSum value is less than zero (0).

(ii) Reset the CuSum value to the acceptance limit (“L”) if the CuSum value exceeds the acceptance limit (“L”).

(d) Determining compliance for a designated grade. (1) A portion of production meets the designated grade if the CuSum value, calculated from the sample unit representing that portion, is equal to or less than the acceptance limit (“L”) for all classes of defects.

(2) A portion of production fails the designated grade if the CuSum value, calculated from the sample unit representing that portion, exceeds the acceptance limit (“L”) for one or more classes of defects.

(e) Evaluation of production failing a designated grade. Production failing a designated grade shall be reevaluated by procedures approved by the USDA.

(f) Assigning a grade. (1) All similarly identified (e.g., codes, subcodes, etc.) production will be assigned the same grade.

(2) The grade assigned to similarly identified production will be the lowest grade assigned to any portion of that similarly identified production.

(g) Redesignation of producer's intended grade. If the intended grade is redesignated during a basic inspection period, a new CuSum sampling plan shall be instituted for each class of defects (or defectives).

(h) Cumulative Sum Sampling (CuSum) Plans for processed fruits and vegetables. (1) Tables VI through X contain the CuSum sampling plans for each of five different standard sample unit sizes. The plans within each table are listed according to increasing values of Acceptable Quality Levels (AQL's).

(2) AQL values of 10.0 or less may be expressed either in “defects per hundred units” or in “percent defective units.” The same sampling plans are used for both. Separate sampling plans must be used for AQL values greater than 10.0.

(3) These tables also provide the quality levels associated with 50 percent and 10 percent probabilities of acceptance for each of the plans. These quality levels are expressed in the same units as the corresponding AQL values.

(4) A separate CuSum sampling plan is chosen for each class of defects (or defectives) by first specifying the desired AQL and then selecting the appropriate standard sample unit size. The quality levels associated with 50 percent and 10 percent probabilities of acceptance may be used as guides to help determine a suitable standard sample unit size.

(a) General. Single sampling plans shall be used as the lot sampling plan for attributes standards under either of the following conditions:

(1) Sampling of the product shall be made during the production period. No grade will be assigned to individual sample units. One grade determination only will be made at the end of the production period for the inspection lot.

(2) Sampling of the product shall be made when the inspection lot is located in a warehouse, truck, railroad car, or other similar conveyance.

(b) Sample size. Samples shall be randomly selected from each inspection lot in the exact number of sample units indicated for the lot size in tables XI through XIV as applicable for canned, frozen, dried, or dehydrated fruits and vegetables.

(c) Determining compliance. (1) An inspection lot meets the requirements of a quality grade if the number of defects (or defectives) is equal to or less than the acceptance numbers of all classes of defects.

(2) An inspection lot fails the requirements of a quality grade if the number of defects (or defectives) exceeds the acceptance number for one or more classes of defects.

(d) Lot single sampling plans for processed fruits and vegetables. (1) Tables XV through XIX contain the lot single sampling plans for each of five different standard sample unit sizes. The plans within each table are listed according to increasing values of Acceptable Quality Levels (AQL's).

(2) AQL values of 10.0 or less may be expressed either in “defects per hundred units” or in “percent defective units.” The same sampling plans are used for both. Separate sampling plans must be used for AQL values greater than 10.0.

(3) A separate lot single sampling plan is chosen for each class of defects (or defectives) by first specifying the desired AQL, the appropriate standard sample unit size, and the number of sample units as specified in § 52.38c (b) of this subpart. The quality levels associated with the Pa=50% and Pa=10% levels are given in the instructional manual.

Each inspector and each licensed sampler shall prepare and sign a certificate of sampling to cover the samples drawn by the respective person, except that in-plant inspectors who inspect the samples which they have drawn need not prepare a certificate of sampling. One copy of each certificate of sampling prepared shall be retained by the licensed sampler and the original and all other copies thereof shall be disposed of in accordance with the instructions of the Administrator.

Each lot from which officially drawn samples are selected shall be marked in such manner as may be prescribed by the Administrator, if such lots do not otherwise possess suitable identification.

Fees and charges for any inspection service shall be paid by the interested party making the application for such service, in accordance with the applicable provisions of the regulations in this part, and if so required by the inspection service, an advance of funds prior to rendering inspection service in an amount suitable to the Administrator, or a surety bond suitable to the Administrator, shall be required as a guarantee of payment for the services rendered. All fees and charges for any inspection service performed pursuant to the regulations in this part shall be paid by check, draft, or money order payable to the United States Department of Agriculture. Remittance shall be sent to the address specified on the bill for collection on or before the due date to avoid a late payment charge.

(a) For each calendar year, AMS will calculate the rate for services, per hour per program employee using the following formulas:

(1) Regular rate. The total AMS inspection program personnel direct pay divided by direct hours, which is then multiplied by the next year's percentage of cost of living increase, plus the benefits rate, plus the operating rate, plus the allowance for bad debt rate. If applicable, travel expenses may also be added to the cost of providing the service.

(2) Overtime rate. The total AMS inspection program personnel direct pay divided by direct hours, which is then multiplied by the next year's percentage of cost of living increase and then multiplied by 1.5 plus the benefits rate, plus the operating rate, plus an allowance for bad debt. If applicable, travel expenses may also be added to the cost of providing the service.

(3) Holiday rate. The total AMS inspection program personnel direct pay divided by direct hours which is then multiplied by the next year's percentage of cost of living increase and then multiplied by 2, plus benefits rate, plus the operating rate, plus an allowance for bad debt. If applicable, travel expenses may also be added to the cost of providing the service.

(b) For each calendar year, based on previous fiscal year/historical actual costs, AMS will calculate the benefits, operating, and allowance for bad debt components of the regular, overtime and holiday rates as follows:

(1) Benefits rate. The total AMS inspection program direct benefits costs divided by the total hours (regular, overtime, and holiday) worked, which is then multiplied by the next calendar year's percentage cost of living increase. Some examples of direct benefits are health insurance, retirement, life insurance, and Thrift Savings Plan (TSP) retirement basic and matching contributions.

(2) Operating rate. The total AMS inspection program operating costs divided by total hours (regular, overtime, and holiday) worked, which is then multiplied by the percentage of inflation.

(3) Allowance for bad debt rate. Total AMS inspection program allowance for bad debt divided by total hours (regular, overtime, and holiday) worked.

(c) The calendar year cost of living expenses and percentage of inflation factors used in the formulas in this section are based on the most recent Office of Management and Budget's Presidential Economic Assumptions.

Such sampling fees as are specifically prescribed by the Administrator in connection with licensing of the particular sampler will be assessed and collected from the applicant by the office of inspection serving the area where services are performed: Provided, That if the employee is an employee of a state, the appropriate authority of the state may make the collection.

For any lot of processed products from which a sample in drawn by a licensed sampler and the applicable sampling fee is collected, as provided in § 52.43, the fees for the other inspection services with respect to such lot shall not include charges for sampling.

For any lot of processed products from which a sample is drawn by a licensed sampler and the sampling fee is not collected by the appropriate authority as provided in § 52.43, the fees and charges for inspection services with respect to such lot shall be the applicable fees and charges prescribed in § 52.42.

The fee to be charged for an appeal inspection shall be at the rates prescribed in this part for other inspection services: Provided, That, if the result of any appeal inspection made for any applicant other than the United States or any agency or instrumentality thereof, discloses that a material error was made in the inspection on which the appeal is made, no inspection fee shall be assessed.

If an applicant cancels a new year-round contract before a full year has elapsed, the applicant shall be charged the difference between the year-round rate and less than year-round rate for the full period the year-round contract was in effect. If an applicant cancels a year-round contract after a full year or more of uninterrupted service, the fee remains at the year-round rate.

The fees to be charged for a plant survey and inspection shall be at the rates prescribed in §§ 52.42 and 52.51.

If the applicant for inspection service requests additional copies of inspection documents and/or inspection data referable to the processed product covered thereby, the applicant may obtain such copies from the supervisor in the office of inspection serving the area where the service was performed at a charge of 1/2 hour per copy in accordance with the rate in § 52.42: Provided, that no charge shall be made for one copy if requested at the time of the original request for inspection. Inspection certificates issued in accordance with § 52.21 may be supplied to any financially interested party at a charge of 1/2 hour per certificate for each seven (7), or fewer copies in accordance with the rate in § 52.42.

Charges may be assessed to cover the cost of travel time incurred in connection with the performance of any inspection service, including appeal inspections, as described in § 52.42. This includes time spent waiting for transportation as well as time spent traveling, but not to exceed eight hours of travel time for any one person for any one day: And provided further, that if travel is by common carrier, no hourly charge may be made for travel time outside the employee's official work hours.

(a) The Administrator may enter into contracts with applicants to perform continuous inspection services or other types of inspection services pursuant to the regulations in this part and other requirements as prescribed by the Administrator in such contract, and the charges for such inspection service provided in such contracts shall be based on such basis as will reimburse the Agricultural Marketing Service of the Department for the full cost of rendering such inspection service as described in § 52.42.

(b) The Administrator may enter into a written memorandum of understanding or contract, whichever may be appropriate, with any administrative agency charged with the administration of a marketing agreement or a marketing order effective pursuant to the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601 et seq.) for the making of inspections pursuant to said agreement or order on such basis as will reimburse the Agricultural Marketing Service of the Department for the full cost of rendering such inspection service based on the formulas in § 52.42. Likewise, the Administrator may enter into a written memorandum of understanding or contract, whichever may be appropriate, with an administrative agency charged with an administration of a similar program operated pursuant to the laws of any State.

(c) Charges for year-round in-plant inspection services on a contract basis will be billed to the applicant monthly for all hours worked with a minimum of 40 hours per week for each inspector assigned to perform the inspection services. Charges for work performed in excess of an employee's regular work schedule will be calculated as described in § 52.42(a)(2).

(d) Charges for less than year-round in-plant inspection services (four or more consecutive 40 hour weeks) on a contract basis will be billed to the applicant monthly for all hours with a minimum of 40 hours for each inspector assigned to perform the inspection services and will be calculated based on the formulas in § 52.42.

(e) No Member of, or Delegate to Congress, or Resident Commissioner, shall be admitted to any share or part of any contract provided for in this section or to any benefit that may arise therefrom, but this provision shall not be construed to extend to such contract if made with a corporation for its general benefit, and shall not extend to any benefits that may accrue from the contract to a Member of, or Delegate to Congress, or a Resident Commissioner in his capacity as a farmer.

(a) General. Use of the approved identification marks described and illustrated in Figures 1 through 10 of this section is restricted to processed products that:

(1) Are clean, safe, and wholesome;

(2) Have been produced or packed in an approved plant.

(3) Are truthfully and accurately labeled.

(4) When graded against a U.S. grade standard, meet the quality requirements for U.S Grade C or better;

(5) Meet applicable fill weight and/or drained weight, Brix or other characteristics of a commodity related to market value;

(6) Have been certified, or have been inspected and are eligible for certification, by an inspector; and, in addition, meet the specific requirements stated in (b), (c), and (d) of this section.

(7) Labels and advertising material containing or referring to approved identification must be approved by USDA inspection service prior to use.

(b) Inspection (Continuous) grade and inspection marks. The official marks approved for use by plants operating under USDA continuous inspection service contracts shall be similar in form and design to the examples in Figures 1 through 10 of this section: Provided, That the official marks illustrated by figures 8 and 9 are limited to products packed by plants operating under an approved Quality Assurance type of inspection contract: And provided further, That the inspection marks illustrated in figures 1 through 4 may only be used on products packed by plants operating under USDA continuous inspection.

(c) In-plant inspection (other than continuous) grade and inspection marks. The official marks approved for use by plants operating under USDA inspection service contracts (other than continuous) requiring a resident inspector shall be limited to those similar in form and design to the examples in Figures 5 through 14 of this section; Provided: That the official marks illustrated by Figures 9 and 10 are limited to products packed by plants operating under an approved Quality Assurance type of an inspection contract.

(d) “Approved plant-lot inspection” grade and inspection marks. Processed products that are produced in an approved plant as defined in § 52.2 and inspected and certified by an inspector on a lot basis may be labeled with an official mark as defined in § 52.3 when adequate control and use is approved. The use of official marks for this type of service is restricted to grade marks (with or without plain shield) and/or the statement “Inspected by the U.S. Department of Agriculture” (with or without plain shield). The official marks shall be similar in form and design as illustrated in figures 11 through 14. Failure to have all lots bearing official marks either inspected and certified or certified as produced in an approved plant shall cause the debarment of the user from receiving subsequent services, and such other actions as provided for in the Agricultural Marketing Act of 1946.

(e) Sampling marks. Processed products which have been sampled for inspection as provided in this part may, at the option of the Department, be identified by an authorized representative of the Department. The products are identified by stamping the container(s) comprising such lot(s), with an official “sampling mark”, similar in form and design to the example in figure 15 of this section. The “sampling marks” will identify products officially sampled by a particular field office. Such mark will include a code identifying the field office performing the sampling.

(f) Removal of labels bearing approved grade or inspection marks. (1) At the time a lot of processed products bearing approved grade or inspection marks is found to be mislabeled, the processor shall separate and retain such lot for relabeling. Removal and replacement of labels shall be done, under the supervision of a USDA inspector, within the time specified by the Administrator or as may be mutually agreed by the processor and the Administrator.

(2) The processor shall be held accountable to the Department for all mislabeled products until the products have been properly labeled.

(3) Clearance for the release of the relabeled product shall be obtained, by the processor, from the inspector.

(g) Licensing and identification of certain official devices. The Administrator may issue licenses permitting the manufacture, identification, and sale of any official device designated as a USDA color standard, defect guide or other similar aid under such terms and conditions as may be specified by the Administrator. Licenses shall be available to all persons meeting conditions prescribed by the Administrator, shall be nonexclusive, and shall be recoverable for cause. No person shall manufacture, identify, distribute or sell any such official device except at the direction of or under license from the Administrator. Such official devices may be marked, tagged or otherwise designated with the prefix “USDA” together with other identifying words or symbols, as prescribed by the license.

(h) Prohibited uses of approved identification. Except as specified in this section, no label or advertising material used upon, or in conjunction, with a processed product, as defined by these Regulations, shall bear a brand name, trademark, product name, company name, or any other descriptive material that incorporates, resembles, simulates, or alludes to, any official U.S. Department of Agriculture certificate of quality or loading, grade mark, grade statement (except honey and maple syrup which may bear such grade mark or statement), continuous inspection mark, continuous inspection statement, sampling mark or sampling statement, or combinations of one or more thereof.

(i) Disposition of labels bearing approved grade or inspection marks when a contract is cancelled. Upon cancellation of a contract, labels bearing approved grade or inspection marks shall remain under the control of the inspection service. The inspection service will approve disposition of said labels for destruction, sale or transfer to another approved plant, remove or obliterate the grade or inspection mark, or other action as may be agreed upon by all interested parties.

(a) The following acts or practices, or the causing thereof, may be deemed sufficient cause for the debarment, by the Administrator, of any person, including any agents, officers, subsidiaries, or affiliates of such person, from any or all benefits of the Act for a specified period. The Rules of Practice Governing Formal Adjudicatory Proceedings Instituted by the Secretary Under Various Statutes set forth in §§ 1.130 through 1.151 of this title and the Supplemental Rules of Practice in part 50 of this chapter shall be applicable to such debarment action.

(1) Fraud or misrepresentation. Any misrepresentation or deceptive or fraudulent practice or act found to be made or committed in connection with:

(i) The making or filing of an application for any inspection service;

(ii) The submission of samples for inspection;

(iii) The use of any inspection report or any inspection certificate, or appeal inspection certificate issued under the regulations in this part;

(iv) The use of the words “Packed under continuous inspection of the U.S. Department of Agriculture,” any legend signifying that the product has been officially inspected, any statement of grade or words of similar import in the labeling or advertising of any processed product;

(v) The use of a facsimile form which simulates in whole or in part any official U.S. certificate for the purpose of purporting to evidence the U.S. grade of any processed product.

(2) Willful violation of the regulations in this subpart. Willful violation of the provisions of this part of the Act.

(i) Country of origin labeling for packed honey. The use of a label or advertising material on, or in conjunction with, packaged honey that bears any official certificate of quality, grade mark or statement, continuous inspection mark or statement, sampling mark or statement, or any combination of the certificates, marks, or statements of the Department of Agriculture is hereby prohibited unless there appears legibly and permanently in close proximity (such as on the same side(s) or surface(s)) to the certificate, mark, or statement, and in at least a comparable size, the one or more names of the one or more countries of origin of the lot or container of honey, preceded by the words ‘Product of’ or other words of similar meaning.

(A) A violation of the requirements of this section may be deemed by the Secretary to be sufficient cause for debarment from the benefits of the regulations governing inspection and certification only with respect to honey.

(3) Interfering with an inspector, inspector's aid, or licensed sampler. Any interference with, obstruction of, or attempted interference with, or attempted obstruction of any inspector, inspector's aide, or licensed sampler in the performance of his duties by intimidation, threat, assault, bribery, or any other means—real or imagined.

All inspectors and licensed samplers are forbidden, during the period of their respective appointments or licenses, to take an active part in political management or in political campaigns. Political activities in city, county, State, or national elections, whether primary or regular, or in behalf of any party or candidate, or any measure to be voted upon, are prohibited. This applies to all appointees or licensees, including, but not limited to, temporary and cooperative employees and employees on leave of absence with or without pay. Wilful violation of this section will constitute grounds for dismissal in the case of appointees and revocation of licenses in the case of licensees.

Employees are authorized to purchase commodity samples for review. Employees must pay and obtain receipts for such purchases and keep receipts subject to inspection by supervisory or other authorized Department employees.

None of the requirements in the regulations in this part shall excuse failure to comply with any Federal, State, county, or municipal laws applicable to the operation of food processing establishments and to processed food products.

Each inspector and licensed sampler shall have in his possession at all times and present upon request, while on duty, the means of identification furnished by the Department to such person.

The information collection requirements contained in this part have been approved by the Office of Management and Budget (OMB) under the provisions of 44 U.S.C. Chapter 35 and have been assigned OMB control no. 0581-0123.

Prior to a plant being approved, or the inauguration of in-plant inspection services, and at such intervals as may be deemed necessary or appropriate, the Administrator will make, or cause to be made, a survey and inspection of the plant where such inspection services are to be performed to determine whether the plant and methods of operation are suitable and adequate for the performance of such service in accordance with:

(a) The regulations in this part, including, but not limited to, the requirements contained in §§ 52.81 through 52.83; and

(b) The terms and provisions of any contract pursuant to which the service is to be performed: Provided, That, such survey(s) shall be repeated at least yearly.

The plant survey and inspection will be based on the Regulations issued under the Federal Food, Drug, and Cosmetic Act—Human Foods; Good Manufacturing Practice (Sanitation) in Manufacture, Processing, Packing, or Holding (21 CFR part 110)—as may be modified or augmented by the Federal Food and Drug Administration, U.S. Department of Health, Education, and Welfare or the Administrator of the Agricultural Marketing Service.

(a) Results of the plant survey shall be reported in writing to a designated plant official.

(b) When the plant meets the requirements for the survey, inspection services may be inaugurated at a time mutually satisfactory to the plant management and USDA.

(c) When the plant fails the requirements of the survey, contract services shall be withheld until corrective action is completed to the satisfaction of the USDA.