CFR Subpart A

CFR Subpart A
in effect

9 C.F.R. § 352.1 Definitions.

The definitions in § 301.2, not otherwise defined in this part, are incorporated into this part. In addition to those definitions, the following definitions will be applicable to the regulations in this part. (a) Act means the applicable provisions of the Agricultural Marketing Act of 1946, as amended (60 Stat. 1087, as amended; 7 U.S.C. 1621 et seq.). (b) Acceptable means suitable for the purpose intended and acceptable to the Food Safety and Inspection Service. (c) Antelope means any of various ruminant deerlike mammals (family Bovidae) chiefly of Africa and southwest Asia that have a slender lean build and usually horns directed upward and backward. (d) Applicant means any interested party who requests any inspection service. (e) Bison (Bison bison), commonly known as the American bison or buffalo, is a species of the genus Bison native to North America. Bison includes catalo or cattalo. (f) Buffalo refers to a subtribe Bubalina of the tribe Bovini within the subfamily Bovinae that includes the water buffalo (Bubalus bubalis) and Cape buffalo (Syncerus caffer). (g) Catalo or Cattalo means any hybrid animal with bison (Bison bison) appearance resulting from direct crossbreeding of bison (Bison bison) and cattle (Bos taurus). (h) Condition means any condition, including, but not limited to, the state of preservation, cleanliness, or soundness of any product or the processing, handling, or packaging which may affect such product. (i) Condition and wholesomeness means the condition of any product, its healthfulness and fitness for human food. (j) Deer refers to the any farm-raised species of the family Cervidae. (k) Exotic animal means any reindeer, elk, deer, antelope, water buffalo, bison, buffalo, or yak. (l) Elk (Cervus canadensis) refers to one of the largest species within the family Cervidae. It is native to North America and in high mountains of Central Asia. (m) Exotic animal inspection service means the personnel who are engaged in the administration, application, and direction of exotic animal inspection programs and services pursuant to the regulations in this part. (n) Exotic animal producer means any interested party that engages in the raising and/or marketing of an exotic animal for commercial purposes. (o) Field ante-mortem inspection means the ante-mortem inspection of an exotic animal away from the official exotic animal establishment's premises. (p) Field designated area means any designated area on the applicant's premises, approved by the Regional Director, where field ante-mortem inspection is to be performed. (q) Identify means to apply official identification to products or containers. (r) Inspection means any inspection by an inspector to determine, in accordance with regulations in this part, (1) the condition and wholesomeness of an exotic animal, or (2) the condition and wholesomeness of edible product of an exotic animal at any state of the preparation or packaging in the official plant where inspected and certified, or (3) the condition and wholesomeness of any previously inspected and certified product of an exotic animal if such product has not lost its identity as an inspected and certified product. (s) Interested party means any person financially interested in a transaction involving any inspection. (t) Official exotic animal establishment means any slaughtering, cutting, boning, curing, smoking, salting, packing, rendering, or similar establishment at which inspection is maintained under the regulations in this part. (u) 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 packaging material. (v) Official identification means any symbol, stamp, label or seal indicating that the product has been officially inspected and/or indicating the condition of the product approved and authorized by the Administrator to be affixed to any product, or affixed to or printed on the packaging material of any product. (w) Program means the Voluntary Exotic Animal Inspection Program of the Food Safety and Inspection Service. (x) Reindeer (Rangifer tarandus), commonly referred to as caribou, is a species within the family Cervidae with circumpolar distribution, native to Arctic, sub-Arctic, tundra, boreal, and mountainous regions of northern Europe, Siberia, and North America. (y) Transport vehicle means any vehicle used to transport an exotic animal. (z) Veterinarian means an authorized veterinarian of the Program employed by the Department or any cooperating State who is authorized by the Secretary to do any work or perform any duty in connection with the Program. (aa) Water buffalo (Bubalus bubalis), commonly known as the domestic water buffalo or Asian water buffalo, is a large bovid originating in the Indian subcontinent, Southeast Asia, and China. (bb) Yak (Bos grunniens) means a long-haired bovid animal originally found throughout the Himalaya region of southern Central Asia and the Tibetan Plateau.

9 C.F.R. § 352.2 Type of service available.

Upon application, in accordance with §§ 352.3, 352.4, and 352.5, the following type of service may be furnished under the regulations in this part: (a) Voluntary Inspection Service. An inspection and certification service for wholesomeness relating to the slaughter and processing of exotic animals and the processing of exotic animal products. All provisions of this part shall apply to the slaughter of exotic animals, and the preparation, labeling, and certification of the exotic animal meat and exotic animal products processed under this exotic animal inspection service. (b) Only exotic animals which have had ante-mortem inspection as described under this part and which are processed in official exotic animal establishments in accordance with this part may be marked inspected and passed. (c) Exotic animals, exotic animal meat and meat food products shall be handled in an official exotic animal establishment to ensure separation and identity of the exotic animal or exotic animal meat and meat food products until they are shipped from the official exotic animal establishment to prevent commingling with other species.

9 C.F.R. § 352.3 Application by official exotic animal establishment for inspection services.

(a) Any person desiring to process an exotic animal, exotic animal carcasses, exotic animal meat and meat food products in an establishment under exotic animal inspection service must receive approval of such establishment and facilities as an official exotic animal establishment prior to the rendition of such service. An application for inspection service to be rendered in an official exotic animal establishment shall be approved in accordance with the provisions contained in §§ 304.1 and 304.2 of subchapter A of this chapter. (b) Initial survey. When an application has been filed for exotic animal inspection service, the Regional Director or designee, shall examine the establishment, premises, and facilities.

9 C.F.R. § 352.4 Application for ante-mortem inspection service in the field.

Any exotic animal producer desiring field ante-mortem exotic animal inspection service must receive approval of the field ante-mortem designated area from the Regional Director or designee prior to the rendition of such service. An application seeking approval of the designated area for ante-mortem inspection shall be obtained from the Regional Director, and completed and submitted to the Regional Director. (a) An initial application for field ante-mortem exotic animal inspection service shall be made by an official exotic animal establishment to the Regional Director. Subsequent requests shall be made by the official exotic animal establishment on behalf of an exotic animal producer to the Regional Director in one of the following manners: (1) telephone, (2) telegraph, (3) mail, or (4) in person as determined by the Regional Director. (b) Upon receipt of the completed application, the Regional Director or designee shall examine the field ante-mortem designated area and facilities for approval of the designated area. (c) All fees involved for the approval of the designated area, including but not limited to any travel, per diem costs, and time required to perform such approval services, shall be paid directly by the applicant to the Regional Director.

9 C.F.R. § 352.5 Fees and charges.

(a) Fees and charges for service under the regulations in this part shall be paid by the applicant for the service in accordance with this section. (b) The fees and charges provided for in this section shall be paid by check, draft, or money order payable to the “Treasurer of the United States” and shall be remitted promptly to the Regional Director upon furnishing to the applicant a statement as to the amount due. (c) The fees to be charged and collected for service under the regulations in this part shall be at the rates specified in §§ 391.2, 391.3, and 391.4 respectively for base time; for overtime including Saturdays, Sundays, and holidays; and for certain laboratory services which are not covered under the base time, overtime, and/or holiday costs. Such fees shall cover the costs of the service and shall be charged for the time required to render such service, including, but not limited to, the time required for the travel of the inspector or inspectors in connection therewith during the regularly scheduled administrative workweek. (d) Charges may also be made to cover other expenses incurred by the Service in connection with the furnishing of the service. (e) Fees and charges for any inspection pursuant to a cooperative agreement with any State shall be paid in accordance with the terms of such cooperative agreement.

9 C.F.R. § 352.6 Denial or withdrawal of inspection service.

(a) For miscellaneous reasons. An application or a request for service may be rejected, or the benefits of the service may be otherwise denied to, or withdrawn from, any person, without a hearing by the appropriate Regional Director: (1) for administrative reasons such as the nonavailability of personnel to perform the service; (2) for the failure of payment for service; (3) in case the application or request relates to exotic animals or exotic animal products which are not eligible for service under this part; (4) for failure to maintain the designated area or the plant in a state of repair approved by the Service; (5) for the use of operating procedures which are not in accordance with the regulations of this part; (6) for alterations of buildings, facilities, or equipment which cannot be approved under the regulations in this part. Notice of such rejection, denial, or withdrawal, and the reasons therefore, shall promptly be given to the person involved. The applicant or recipient shall be notified of such decision to reject an application or request for service or to deny or withdraw the benefits of the service, and the reasons therefor, in writing in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)), or orally. Such decision shall be effective upon such oral or written notification, whichever is earlier, to the applicant or recipient. If such notification is oral, the person making such decision shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the applicant or recipient in the manner prescribed in § 1.147(b) of the rules of practice (7 CFR 1.147(b)). (b) For disciplinary reasons—Basis for denial or withdrawal. An application or request for service may be denied, or the benefits of the service may be withdrawn from, any person or entity who, or whose officer, employee or agent in the scope of his employment or agency: (1) Has willfully made any misrepresentation or has committed any other fraudulent or deceptive practice in connection with any application or request for service under this part; (2) has given or attempted to give, as a loan or for any other purpose, any money, favor or other thing of value, to any employee or agent of the Department or a cooperating State authorized to perform any function under this part; (3) has interfered with or obstructed, or attempted to interfere with or to obstruct, any employee or agent of the Department or cooperating State in the performance of his or her duties under this part by intimidation, threats, assaults, abuse, or any other improper means; (4) has knowingly represented that any exotic animal carcass, or exotic animal product, has been officially inspected and passed by an authorized inspector under this part, when it had not, in fact, been so inspected; (5) has been convicted of more than one misdemeanor under any law based upon the acquiring, handling, or distributing of adulterated, mislabeled, or deceptively packaged good, or fraud in connection with transactions in food, or any felony; Provided, an application or a request for service made in the name of a person or entity otherwise eligible for service under the regulations may be denied, or the benefits of the service may be withdrawn, from such a person or entity in case the service is or would be performed at a location operated by a person or entity, from whom the benefits of the service are currently being denied or have been withdrawn under this part; or by a person or entity having an officer, director, partner, manager or substantial investor from whom the benefits of service under this part are currently being denied or have been withdrawn under this part, and who has any authority with respect to the location where service is or would be performed; or in case the service is or would be performed with respect to any exotic animal or exotic animal product in which any person or entity, from whom the benefits of service are currently being denied or have been withdrawn under this part, has contract or other financial interest. (c) Procedure. (1) An application or request for service may be denied or benefits of the service may be withdrawn by the Secretary, as provided by paragraph (b) of this section, after notice and opportunity for hearing before a designated official of the Department. The Administrator may suspend service under this paragraph without hearing, pending final determination of the matter, when he determines that the public health, interest or safety so requires. The applicant or recipient shall be notified of the Administrator's decision to suspend service, and the reasons therefor, in writing or orally. The Administrator's decision to suspend service under this part shall be effective upon such an oral or written notification, whichever is earlier, to the applicant or recipient. If such notification is oral, the Administrator shall confirm such decision, and the reasons therefor, in writing, as promptly as circumstances permit, and such written confirmation shall be served upon the applicant or recipient in the manner prescribed in 1.147(b) of Departmental rules of practice (7 CFR 1.147(b)). (2) The written notification specified in paragraph (c) of this section, which shall constitute the complaint in the proceeding, shall briefly set forth the reason for the denial or withdrawal of service, including allegations of fact which constitute a basis for the action. After the complaint is served upon the respondent, as provided in § 1.147(b) of Departmental rules of practice (7 CFR 1.147(b)), the proceeding shall thereafter be conducted in accordance with rules of practice which shall be adopted for the proceeding.

9 C.F.R. § 352.7 Marking and labeling of inspected products.

Wording and form of inspection mark. This wording shall be contained within a triangle in the form and arrangement shown in this section. The establishment number of the official establishment shall be included in the triangle unless it appears elsewhere on the packaging material. Ordering and manufacture of the triangle brand shall be in accordance with the provisions in 9 CFR 317.3(c) of the Federal meat inspection regulations. The Administrator may approve the use of abbreviations of such inspection mark, and such approved abbreviations shall have the same force and effect as the inspection mark. The inspection mark or approved abbreviation shall be applied, under the supervision of the inspector, to the inspected and passed edible product, packaging material, immediate container or shipping container. When the inspection mark or approved abbreviation is used on packaging material, immediate container or shipping container, it shall be printed on such material or container or on a label to be affixed to the packaging material or container. The name and address of the packer or distributor of such product shall be printed on the packaging material or label. The inspection marks may be stenciled on the container, and when the inspection mark is so stenciled, the name and address of the packer or distributor may be applied by the use of a stencil or rubber stamp. The name and address of the packer or distributor, if prominently shown elsewhere on the packaging material or container, may be omitted from insert labels which bear an official identification if the applicable establishment number is shown. All labels intended for use on inspected and passed exotic animal products must be approved in accordance with Part 412 of this chapter. (a) The inspection mark to be applied to inspected and passed carcasses and parts of carcasses of an exotic animal, and products as therefrom approved by the Administrator, shall be in the form and arrangement as indicated in the example below. 1 The establishment number of the official establishment shall be set forth if it does not appear on the packaging material or container. (1) For application to exotic animal carcasses, primal parts and cuts therefrom, exotic animal livers, exotic animal tongues, and exotic animal hearts. (2) For application to exotic animal calf carcasses. (3) For application to exotic animal tails. (4) For application to burlap, muslin, cheesecloth, heavy paper, or other acceptable material that encloses carcasses or parts of carcasses. (b) The official inspection mark to be shown on all labels. 1 (1) For inspected and passed products of an exotic animal shall be in the following form, except that it need not be of the size illustrated, provided that it is a sufficient size and of such color as to be conspicuously displayed and readily legible and the same proportions of letter size and boldness are maintained as illustrated: (2) This official mark shall be applied by mechanical means and shall not be applied by a hand stamp. (3) The official inspection legend described in paragraph (b)(1) of this section shall also be used on shipping containers, bond labels, artificial casings, and other articles with the approval of the Administrator. (c) Any brand, stamp, label or other device approved by the Administrator and bearing any official mark prescribed in paragraph (a) or (b) of this section shall be an official device for purposes of the Act.

9 C.F.R. § 352.8 Time of inspection in the field and in an official exotic animal establishment.

The official exotic animal establishment on behalf of the applicant shall notify the Regional Director or designee, in advance, of the hours when such inspection is desired. Inspection personnel shall have access at all times to every part of any field ante-mortem inspection area and/or official exotic animal establishment to which they are assigned.

9 C.F.R. § 352.9 Report of inspection work.

Reports of the work of inspection carried on within the field ante-mortem inspection area of an exotic animal producer's premises and/or official exotic animal establishment shall be forwarded to the Administrator by the ante-mortem inspector. The applicant for such inspection shall furnish to the Administrator such information as may be required on forms provided by the Administrator.

9 C.F.R. § 352.10 Ante-mortem inspection.

An ante-mortem inspection of an exotic animal shall, where and to the extent considered necessary by the Administrator and under such instructions as he may issue from time to time, be made on the day of slaughter of an exotic animal, in one of the following listed ways or as determined by the Administrator. Humane handling of an exotic animal during ante-mortem inspection shall be in accordance with the provisions contained in 9 CFR 313.2. Immediately after the animal is stunned or killed, it shall be shackled, hoisted, stuck and bled. (a) To be performed on an exotic animal in the field in a designated area of an exotic animal producer's premises. (1) Reindeer, elk, deer, antelope, bison and water buffalo are eligible for field ante-mortem inspection. The field ante-mortem designated area must be approved by the Regional Director or designee prior to rendition of the service. (2) Any person who desires to receive field ante-mortem inspection must provide: (i) Notification from an official exotic animal establishment to the Regional Director or designee. (ii) A field ante-mortem designated area. (iii) A stunning/slaughtering area which is in a condition that minimizes the possibility of soiling the animal when stunned/slaughtered and bled as determined by the inspector. (iv) A transport vehicle that is as sanitary as practicable as determined by the inspector. (3) The ante-mortem inspector shall determine the acceptableness and safety of performing field ante-mortem inspection. If, in the opinion of the ante-mortem inspector, an unsafe circumstance exists at the time of field ante-mortem inspection, the service shall be denied. (4) An exotic animal that, in the ante-mortem inspector's opinion, does not pass ante-mortem inspection must be withheld from slaughter. (5) Stunning to render the animal unconscious shall be in accordance with 9 CFR 313.15 or 313.16. (6) All stunned/slaughtered and bled exotic animals shall be tagged with a “U.S. Suspect” tag in an ear by the ante-mortem inspector or designee prior to loading on the transport vehicle. (7) The transport of intact exotic animal carcasses to an official exotic animal establishment for post-mortem inspection shall be as expedient as possible, and must be within the same day as field slaughter. (8) Ante-mortem cards (Form MP 402-2) shall be filled out by the ante-mortem inspector. One copy is to be retained by the ante-mortem inspector. The other copy shall accompany the transport vehicle to the official exotic animal establishment and shall be delivered to the post-mortem veterinarian. (9) The ante-mortem inspector shall supervise all phases of field ante-mortem inspection. (b) To be performed on exotic animals that are inside of the transport vehicle at an official exotic animal establishment. (1) Reindeer, elk, deer, antelope, bison, and water buffalo are eligible for transport vehicle inspection. (2) The ante-mortem inspector shall remain outside the transport vehicle while performing ante-mortem inspection. (3) The person requesting transport vehicle inspection must provide a transport vehicle that is as sanitary as practicable and that would safely and thoroughly permit the inspection of an exotic animal from outside of the transport vehicle as determined by the inspector. (4) The ante-mortem inspector shall determine the adequacy and safety of performing ante-mortem inspection. If, in the ante-mortem inspector's opinion, the transport vehicle is not adequate or safe to perform ante-mortem inspection, the service shall be denied. (c) To be performed in pens at official exotic animal establishments. The inspection shall be conducted in accordance with the provisions contained in 9 CFR part 309.

9 C.F.R. § 352.11 Post-mortem inspection.

(a) Post-mortem inspection of reindeer, elk, deer, antelope, bison and water buffalo shall be conducted in accordance with the provisions contained in 9 CFR part 310 or as determined by the Administrator. (b) The post-mortem examination of field ante-mortem-inspected exotic animals must occur in the shortest length of time practicable and on the day that field ante-mortem inspection is performed to minimize the changes in the carcass which can affect the post-mortem examination, disposition and wholesomeness of the carcass and its parts. (c) The post-mortem veterinarian shall inspect and make the disposition of all incoming “U.S. Suspect” tagged exotic animals.

9 C.F.R. § 352.12 Disposal of diseased or otherwise adulterated carcasses and parts.

This shall be conducted in accordance with the provisions contained in 9 CFR part 311.

9 C.F.R. § 352.13 Handling and disposal of condemned or other inedible exotic animal products at official exotic animal establishments.

This shall be conducted in accordance with the provisions contained in 9 CFR part 314.

9 C.F.R. § 352.14 Entry into official establishments; reinspection and preparation of products.

This shall be conducted in accordance with the provisions contained in 9 CFR 318.1, 318.2, and 318.3.

9 C.F.R. § 352.15 Records, registration, and reports.

This shall be conducted or maintained in accordance with the provisions contained in 9 CFR 320.1 through 320.7.

9 C.F.R. § 352.16 Exports.

This shall be conducted in accordance with the provisions contained in 9 CFR 322.1 through 322.5.

9 C.F.R. § 352.17 Transportation.

This shall be conducted in accordance with the provisions contained in §§ 325.1 through 325.21.

9 C.F.R. § 352.18 Cooperation of States in Federal programs.

Under the “Talmadge-Aiken Act” of September 28, 1962 (7 U.S.C. 450), the Administrator is authorized to utilize employees and facilities of States in carrying out Federal functions.

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