[Code of Federal Regulations] [Title 9, Volume 1] [Revised as of January 1, 2004] From the U.S. Government Printing Office via GPO Access [CITE: 9CFR95.4] [Page 512-514] TITLE 9--ANIMALS AND ANIMAL PRODUCTS CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE PART 95_SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES--Table of Contents Sec. 95.4 Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, certain tallow other than tallow derivatives, and serum due to bovine spongiform encephalopathy. (a) Except as provided in paragraphs (c) through (f) of this section, the importation of the following is prohibited: (1) Any of the materials listed in paragraphs (a)(1)(i) through (a)(1)(iv) of this section that have been derived from animals that have been in any region listed in Sec. 94.18(a) of this chapter: (i) Processed animal protein, tankage, offal, and tallow other than tallow derivatives, unless, in the opinion of the Administrator, the tallow cannot be used in feed, regardless of the animal species from which the material was derived; [[Page 513]] (ii) Glands and unprocessed fat tissue derived from ruminants; (iii) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal, regardless of the animal species from which the material was derived; and (iv) Derivatives of glands from ruminants. (2) Any of the materials listed in paragraphs (a)(2)(i) through (a)(2)(iv) of this section that have been stored, rendered, or otherwise processed in a region listed in Sec. 94.18(a) of this chapter, or that have otherwise been associated with a facility in a region listed in Sec. 94.18(a) of this chapter or with any material listed in paragraph (a)(1) through (a)(3) of this section: (i) Processed animal protein, tankage, offal, and tallow other than tallow derivatives, unless, in the opinion of the Administrator, the tallow cannot be used in feed, regardless of the animal species from which the material was derived; (ii) Glands and unprocessed fat tissue derived from ruminants; (iii) Processed fats and oils, and derivatives of processed animal protein, tankage, and offal, regardless of the animal species from which the material was derived; and (iv) Derivatives of glands from ruminants. (3) Products containing any of the items listed in paragraphs (a)(1) and (a)(2) of this section. (b) Except as provided in paragraphs (d) and (f) of this section, the importation of serum from ruminants that have been in any region listed in Sec. 94.18(a) of this chapter is prohibited, except that serum from ruminants may be imported for scientific, educational, or research purposes if the Administrator determines that the importation can be made under conditions that will prevent the introduction of bovine spongiform encephalopathy into the United States. Serum from ruminants imported in accordance with this paragraph must be accompanied by a permit issued by APHIS in accordance with Sec. 104.4 of this chapter, and must be moved and handled as specified on the permit. (c) Materials that are otherwise prohibited importation into the United States under paragraph (a) of this section may be imported into the United States if the following conditions are met prior to importation: (1) The material is derived from a nonruminant species, or from a ruminant species if the ruminants have never been in any region listed in Sec. 94.18(a) of this chapter. (2) All steps of processing and storing the material are carried out in a foreign facility that has not been used for the processing and storage of materials derived from ruminants that have been in any region listed in Sec. 94.18(a) of this chapter. (3) The facility demonstrates to APHIS that the materials intended for exportation to the United States were transported to and from the facility in a manner that would prevent cross-contamination by or commingling with prohibited materials. (4) If the facility processes or handles any material derived from mammals, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt. (5) The facility allows periodic APHIS inspection of its facilities, records, and operations. (6) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the region of export certifying that the [[Page 514]] conditions of paragraphs (c)(1) through (c)(3) of this section have been met. (7) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import- Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/ncie.) (d) The importation of serum albumin, serocolostrum, amniotic liquids or extracts, and placental liquids derived from ruminants that have been in any region listed in Sec. 94.18(a) of this chapter, and of collagen and collagen products that meet any of the conditions listed in paragraphs (a)(1) through (a)(3) of this section, is prohibited unless the following conditions have been met: (1) The article is imported for use as an ingredient in cosmetics; (2) The person importing the article has obtained a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3 (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/ncie.); and (3) The permit application states the intended use of the article and the name and address of the consignee in the United States. (e) Insulin otherwise prohibited from importation into the United States under paragraph (a) of this section is not prohibited from importation under that paragraph if the insulin is for the personal medical use of the person importing it and if the person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http:// www.aphis.usda.gov/ncie. Note: Insulin that is not prohibited from importation under this paragraph may be prohibited from importation under other Federal laws, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C, 321 et seq.) (f) Articles that are prohibited importation into the United States in accordance with this section may transit the United States for immediate export if the following conditions are met: (1) The person moving the articles has obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS form 16-3. (VS Form 16-3 may be obtained from APHIS, Veterinary Services, National Center for Import-Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http:// www.aphis.usda.gov/ncie.) (2) The articles are sealed in leakproof containers bearing serial numbers during transit. Each container remains sealed during the entire time that it is in the United States. (3) The person moving the articles notifies, in writing, the Plant Protection and Quarantine Officer at both the place in the United States where the articles will arrive and the port of export prior to such transit. The notification includes the: (i) United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors permit number; (ii) Times and dates of arrival in the United States; (iii) Times and dates of exportation from the United States; (iv) Mode of transportation; and (v) Serial numbers of the sealed containers. (4) The articles transit the United States in Customs bond. (Approved by the Office of Management and Budget under control numbers 0579-0015 and 0579-0183) [66 FR 42600, Aug. 14, 2001] [[Page 515]]