9 CFR 309.16 - Livestock suspected of having biological residues.

§ 309.16 Livestock suspected of having biological residues.
(a) Except as provided by paragraph (d) of this section, livestock suspected of having been treated with or exposed to any substance that may impart a biological residue which would make the edible tissues unfit for human food or otherwise adulterated shall be handled in compliance with the provisions of this paragraph. They shall be identified at official establishments as “U.S. Condemned.” These livestock may be held under the custody of a Program employee, or other official designated by the Administrator, until metabolic processes have reduced the residue sufficiently to make the tissues fit for human food and otherwise not adulterated. When the required time has elapsed, the livestock, if returned for slaughter, must be re-examined on ante-mortem inspection. To aid in determining the amount of residue present in the tissues, officials of the Program may permit the slaughter of any such livestock for the purpose of collecting tissues for analysis for the residue. Such analysis may include the use of inplant screening procedures designed to detect the presence of antimicrobial residues in any species of livestock.
(b) All carcasses and edible organs and other parts thereof, in which are found any biological residues which render such articles adulterated, shall be marked as “U.S. Condemned” and disposed of in accordance with § 314.1 or § 314.3 of this chapter.
(c) [Reserved]
(d) Calves shall not be presented for ante-mortem inspection in an official establishment except under the provisions of this paragraph.
(1) Definitions. For purposes of this paragraph, the following definitions shall apply:
(i) Calf. A calf up to 3 weeks of age or up to 150 pounds.
(ii) Certified calf. A calf that the producer and all other subsequent custodians of the calf certify in writing has not been treated with any animal drug while in his or her custody or has been treated with one or more drugs in accordance with FDA approved label directions while in his or her custody and has been withheld from slaughter for the period(s) of time specified by those label directions.
(iii) Healthy calf. A calf that an inspector determines shows no visual signs of disease or treatment of disease at ante-mortem inspection.
(iv) Producer. The owner of the calf at the time of its birth.
(v) Sick calf. A calf that an inspector on ante-mortem inspection determines has either signs of treatment or signs of disease.
(vi) Veterinary medical officer. An inspector of the Program that has obtained a Doctor of Veterinary Medicine degree which is recognized by the Program.
(2) General requirements.
(i) The identity of the producer of each calf presented for ante-mortem inspection shall be made available by the official establishment to the inspection prior to the animal being presented for ante-mortem inspection.
(ii) The inspector shall segregate the calves presented for ante-mortem inspection at the establishment and identify each calf as one of the following: (a) Certified, (B) noncertified, or (C) previous residue condemnation.
(3) Certified group.
(i) For a calf to be considered certified, the producer and all other subsequent custodians of the calf must certify in writing that while the calf was in his or her custody, the calf was not treated with animal drugs or was treated with one or more drugs in accordance with FDA approved label directions and was withheld from slaughter for the period(s) of time specified by those label directions. All prior certifications must be presented with the animal at the time of slaughter. The certifications shall contain a list of the calves with accompanying identification numbers, as required by paragraph (d)(3)(ii) of this section, followed by the following language:
I hereby certify that, while in my custody, from ____ to ____ (time period of custody), the above-listed calf or calves have not been treated with drugs, or have been treated with one or more drugs in accordance with FDA approved label directions and have been withheld from slaughter for the period(s) of time specified by those label directions. I certify that, to the best of my knowledge and belief, all information contained herein is true, that the information may be relied upon at the official establishment, and that I understand that any willful falsification of this certification is a felony and may result in a fine of up to $250,000 for an individual or up to $500,000 for an organization, or imprisonment for not more than 5 years, or both (21 U.S.C. 677, 18 U.S.C. 1001 and 3571).
Executed on
(date of certification)
(signature of certifier)
(typed or printed name and address of certifier)
(business of certifier)
(ii) Each calf must be identified by use of backtag, eartag, or other type of secure identification which displays a number which shall be recorded on all written certifications.
(iii) The inspector shall have segregated for veterinary medical officer examination any certified calf which he or she determines to show any sign of disease or which is not identified individually. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21 (c) and (d).
(iv) The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c) and (d).
(4) Noncertified group. On ante-mortem inspection, the inspector shall have segregated for veterinary medical officer examination any calf which he or she determines to show any sign of disease. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21(c). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(c).
(5) Calves from producers with previous residue condemnation. On ante-mortem inspection, the inspector shall have segregated for veterinary medical officer examination any calf which he or she determines to show any sign of disease. Such animal will be tagged as “U.S. Suspect” and its carcass will be retained on post-mortem inspection and handled in accordance with § 310.21(e). The inspector shall handle the remaining carcasses of healthy animals in accordance with § 310.21(e).
(e) The name of each and all person(s) who sold or consigned each swine to the establishment shall be made available by the establishment to any Program employee or other authorized employee of the United States Department of Agriculture upon that employee's request and presentation of his or her official credentials. Swine identification, by means approved by the Animal and Plant Health Inspection Service, USDA, under part 71 of this title, must be maintained throughout post-mortem inspection, in accordance with § 310.23(a) of this subchapter.
(Recordkeeping requirements approved by the Office of Management and Budget under control number 0583-0053)
[36 FR 24928, Dec. 24, 1971, as amended at 44 FR 45606, Aug. 3, 1979; 44 FR 59499, Oct. 16, 1979; 47 FR 746, Jan. 7, 1982; 47 FR 41336, Sept. 20, 1982; 50 FR 32164, Aug. 9, 1985; 50 FR 53127, Dec. 30, 1985; 52 FR 2104, Jan. 20, 1987; 53 FR 40387, Oct. 14, 1988; 55 FR 7474, Mar. 2, 1990]

Title 9 published on 2014-01-01

no entries appear in the Federal Register after this date.

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

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

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


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

§ 601 - Definitions

§ 602 - Congressional statement of findings

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

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

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

§ 606 - Inspection and labeling of meat food products

§ 607 - Labeling, marking, and container requirements

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

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

§ 610 - Prohibited acts

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

§ 612 - Notification

§ 613 - Plans and reassessments

§ 614 - Repealed.

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

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

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

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

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

§ 620 - Imports

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

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

§ 623 - Exemptions from inspection requirements

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

§ 625 - Inapplicability of certain requirements to catfish

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

§ 642 - Recordkeeping requirements

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

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

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

§ 661 - Federal and State cooperation

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

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

§ 673 - Seizure and condemnation

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

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

§ 676 - Violations

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

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

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

§ 679a - Safe Meat and Poultry Inspection Panel

§ 679b - Pasteurization of meat and poultry

§ 679c - Expansion of Food Safety Inspection Service activities

§ 680 - Authorization of appropriations

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

§ 691 - Omitted

§ 692 - Inspection extended to reindeer

§ 693 - Inspection of dairy products for export

§ 694 - Authorization of appropriations

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