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(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.

OFFICIALLY SAMPLED

OCTOBER 22, 1985

U.S. DEPARTMENT OF AGRICULTURE

42

FIGURE 15

(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.

(1) 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.

[38 FR 25169, Sept. 12, 1973, as amended at 40 FR 48934, Oct. 20, 1975. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981; 48 FR 12326, Mar. 24, 1983; 51 FR 20446, June 5, 1986]

$52.54 Debarment of service.

(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 withdrawal of inspection and grading services set forth in 7 CFR Part 50 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) Wilful violation of the regulations in this subpart. Wilful violation of the provisions of this part of the Act.

(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 in

timidation, threat, assault, bribery, or any other means—real or imagined.

[38 FR 25170, Sept. 12, 1973. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981]

$52.55 Political activity.

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.

$52.56 Purchase of commodity samples for review.

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.

[48 FR 12330, Mar. 24, 1983]

$52.57 Compliance with other laws.

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.

$52.58 Identification.

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 per

son.

$52.59 OMB control numbers assigned pursuant to the Paperwork Reduction Act.

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.

(44 U.S.C. Ch. 35)

[49 FR 23826, June 8, 1984]

REQUIREMENTS FOR PLANTS TO BE APPROVED AND FOR PLANTS USING CONTRACT IN-PLANT INSPECTION SERVICES1

SOURCE: Sections 52.81 to 52.83 appear at 38 FR 25170, Sept. 12, 1973, unless otherwise noted. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981.

$52.81 Plant survey.

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.

$52.82 Basis of survey and plant inspection.

The plant survey and inspection will be based on the Regulations issued under the Federal Food, Drug, and Cosmetic Act-Human Foods; Good Manu

1 Compliance with the above requirements does not excuse failure to comply with all applicable sanitary rules and regulations of city, county, State, Federal, or other agencies having jurisdiction over such plants and operations.

facturing 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.

$52.83 Reporting results of the plant survey and inauguration of inspection services.

(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.

Subpart-United States Standards for Inspection by Variables

SOURCE: 38 FR 10447, Apr. 27, 1973, unless otherwise noted. Redesignated at 42 FR 32514, June 27, 1977 and at 46 FR 63203, Dec. 31, 1981.

PURPOSE, OPTIONS, REQUIREMENTS

§ 52.201 Purpose.

The purpose of these standards is to: (a) Designate and define symbols and terminology associated with statistical quality control;

(b) Prescribe a procedure for collecting and recording data that is adaptable to use for statistical quality control; and

(c) Provide a statistical procedure for determining compliance of a variable, which may be any measurable product characteristic, with a specified require

ment.

$52.202 Options.

These standards provide for three options, any one of which may be applied to determine compliance of a variable. These options are based on procedures employing the use of:

(a) Conventional averages; (b) The median; or

(c) Moving averages.

$52.203 Requirements for application.

These standards are written in general terms to be applied to any variable. Therefore, in order to use these standards it will be necessary to predetermine:

(a) The sampling allowance code;
(b) The sampling frequency;
(c) The values for:
(1) Specified averages;
(2) Warning limits;

(3) Reject limits; and

(4) Maximum range, when requested. DEFINITIONS

§ 52.204 Definitions.

Statistical and inspection symbols and terms and their respective definitions which are pertinent to the understanding and application of these standards follow.

(a) Symbols defined.

LRL The lower reject limit for individual measurements. The lowest value an individual measurement may have without causing the production to be rejected for failure to meet prescribed requirements for individual measurements.

LRL The lower reject limit for subgroup averages or medians. The lowest value the average or median of a subgroup may have without causing the production to be rejected for failure to meet prescribed requirements for subgroup averages.

LWL-The lower warning limit for individual measurements. This value serves as a warning point that the production may have reached a level where the chances of subsequently finding an individual measurement that will fall below the LRL have increased to a degree that the production may be in danger of rejection.

LWL-The lower warning limit for subgroup averages or medians. This value serves as a warning point that the quality of the production may have reached a level where the chances of subsequently finding a subgroup average or median that will fall below LRL have increased to a degree that the production may be in danger of rejection.

m-The number of subgroups in a sample.

Mi-The median of all the individual measurements in a subgroup.

Mi-The median of all the individual measurements or subgroup medians (Mi) in a sample.

n-The total number of sample units or measurements in a sample. n=(m) (n.).

n. The number of sample units or measurements in a subgroup.

R-A range of measurements, the difference between the highest measurement and lowest measurement within a subgroup.

R-The average range of all the subgroup ranges.

R-A specified average range value. Rmax A specified maximum range for a subgroup.

s-The standard deviation of the individual measurements.

sx-The standard deviation of the averages.

URL The upper reject limit for individual measurements. The highest value an individual measurement may have without causing the production to be rejected for failure to meet prescribed requirements for individual

measurements.

URL The upper reject limit for subgroup averages or medians. The highest value the average or median of a subgroup may have without causing the production to be rejected for failure to meet prescribed requirements for subgroup averages.

UWL-The upper warning limit for individual measurements. This value serves as a warning point that the quality of the production may have reached a level where the chances of subsequently finding an individual measurement that will exceed the URL have increased to a degree that the production may be in danger of rejection.

UWL The upper warning limit for subgroup averages or medians. This value serves as a warning point that the quality of production may have reached a level where the chances of subsequently finding a subgroup average or median that will exceed the URL have increased to a degree that the production may be in danger of rejection.

X-The value of an individual measurement for a variable.

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Average. The arithmetic mean of two or more values; the sum of all measurements divided by the number of measurements.

Median. The median is the middle value with respect to magnitude of all the individual measurements when the number of individual measurements is odd. When the number of individual measurements is even and arranged according to magnitude, the median is the arithmetic mean of the two middle values.

Moving average. A scheme under which a series of consecutive measurements are made until such number equals the subgroup size; the average is then determined and recorded; as new data is collected from continuing production, the first measurement of the subgroup is dropped, the next new value is added, and a new average is calculated; this process of adding new measurements, dropping the oldest measurement in the subgroup, and calculating the average on the new data is continued throughout the production. Example:

X=(5+7+3)/3=5.00

X2=(7+3+4)/3=4.67 X3=(3+4+6)/3=4.33

Moving range. The difference between the highest measurement and lowest measurement within a subgroup from which a moving average is obtained.

One-sided specification. A specification with rejection limits applicable to only one side of the specified lot average. When only lower reject limits apply, the term "low-sided specification" may be used. When only upper re

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