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Title 21 — Food and DrugsRelease 119-73not60

§143 Inspection; Certified Statement in Lieu Thereof; Waiver of Requirements of Section 142; Regulations; Suspension and Revocation of Permits

Title 21 › Chapter 4— ANIMALS, MEATS, AND MEAT AND DAIRY PRODUCTS › Subchapter IV— IMPORTATION OF MILK AND CREAM › § 143

Last updated Apr 5, 2026|Official source

Summary

The Secretary of Health and Human Services must arrange inspections to make sure imported milk and cream meet the rules in clauses 1, 2, and 3 of section 142. If the milk and cream pass, the Secretary will give permits to people who apply to ship them into the United States. Instead of doing an inspection, the Secretary can accept a signed, certified statement from an accredited official of a foreign government, a U.S. state, or a city saying those clauses were followed. The Secretary will create the form for that certificate and make rules about issuing permits. If inspections for clauses 1, 2, and 3 are not yet set up, the Secretary must issue temporary permits to applicants. The Secretary can also make and enforce rules for handling and inspecting milk, cream, cows, barns, and related facilities, and for transporting and importing milk and cream. The Secretary can waive clause 4 for condenseries that must sterilize milk, but the milk’s bacteria count cannot exceed 1,200,000 per cubic centimeter and the farm must be within 15 miles of the condensery. The Secretary can waive clauses 2 and 5 for creameries or condensing plants within 20 miles that only import milk to pasteurize or condense. If milk brought in under any waiver is later sold, used, or disposed of raw or not as required, the permit will be revoked and the importer may face fines, jail, or other penalties. The Secretary may suspend or cancel any permit if rules are broken or the milk does not meet section 142.

Full Legal Text

Title 21, §143

Food and Drugs — Source: USLM XML via OLRC

The Secretary of Health and Human Services shall cause such inspections to be made as are necessary to insure that milk and cream are so produced and handled as to comply with the provisions of section 142 of this title, and in all cases when he finds that such milk and/or cream is produced and handled so as not to be unfit for importation under clauses 1, 2, and 3 of section 142 of this title, he shall issue to persons making application therefor permits to ship milk and/or cream into the United States: Provided, That in lieu of the inspections to be made by or under the direction of the Secretary he may, in his discretion, accept a duly certified statement signed by a duly accredited official of an authorized department of any foreign government and/or of any State of the United States or any municipality thereof that the provisions in clauses 1, 2, and 3 of section 142 of this title have been complied with. Such certificate of the accredited official of an authorized department of any foreign government shall be in the form prescribed by the Secretary, who is authorized and directed to prescribe such form as well as rules and regulations regulating the issuance of permits to import milk or cream into the United States. The Secretary is authorized, in his discretion, to waive the requirement of clause 4 of section 142 of this title when issuing permits to operators of condenseries in which milk and/or cream is used when sterilization of the milk and/or cream is a necessary process: Provided, however, That no milk and/or cream shall be imported whose bacterial count per cubic centimeter in any event exceeds one million two hundred thousand: Provided, further, That such requirements shall not be waived unless the farm producing such milk to be imported is within a radius of fifteen miles of the condensery in which it is to be processed: Provided further, That if milk and/or cream imported when the requirements of clause 4 of section 142 of this title, have been so waived, is sold, used, or disposed of in its raw state or otherwise than as condensed milk by any person, the permit shall be revoked and the importer shall be subject to fine, imprisonment, or other penalty prescribed by this subchapter. The Secretary is directed to waive the requirements of clauses 2 and 5 of section 142 of this title insofar as the same relate to milk when issuing permits to operators of, or to producers for delivery to, creameries and condensing plants in the United States within twenty miles of the point of production of the milk, and who import no raw milk except for pasteurization or condensing: Provided, That if milk imported when the requirements of clauses 2 and 5 of section 142 of this title have been so waived is sold, used, or disposed of in its raw state, or otherwise than as pasteurized, condensed, or evaporated milk by any person, the permit shall be revoked and the importer shall be subjected to fine, imprisonment, or other penalty prescribed by this subchapter. The Secretary is authorized and directed to make and enforce such regulations as may in his judgment be necessary to carry out the purpose of this subchapter for the handling of milk and cream, for the inspection of milk, cream, cows, barns, and other facilities used in the production and handling of milk and/or cream and the handling, keeping, transporting, and importing of milk and/or cream: Provided, however, That unless and until the Secretary shall provide for inspections to ascertain that clauses 1, 2, and 3 of section 142 of this title have been complied with, the Secretary shall issue temporary permits to any applicants therefor to ship or transport milk and/or cream into the United States. The Secretary is authorized to suspend or revoke any permit for the shipment of milk or cream into the United States when he shall find that the holder thereof has failed to comply with the provisions of or has violated this subchapter or any of the regulations made hereunder, or that the milk and/or cream brought or shipped by the holder of such permit into the United States is not produced and handled in conformity with, or that the quality thereof does not conform to, all of the provisions of section 142 of this title.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Change of Name

“Secretary of Health and Human Services” substituted in text for “Secretary of Health, Education, and Welfare” pursuant to section 509(b) of Pub. L. 96–88, which is classified to section 3508(b) of Title 20, Education.

Executive Documents

Transfer of Functions

For

Transfer of Functions

of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 143

Title 21 — Food and Drugs

Last Updated

Apr 5, 2026

Release point: 119-73not60