[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR95.4]

[Page 565-569]
 
                  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
 
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 (h) 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;
    (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.

[[Page 566]]

    (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 prohibited importation 
under paragraphs (a)(1) and (a)(2) of this section.
    (b) Except as provided in paragraphs (d) and (h) 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) Except for facilities in regions listed in Sec. 94.18(a)(3) of 
this subchapter, 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. In facilities in regions listed in Sec. 94.18(a)(3) of this 
subchapter, the inspections that would otherwise be conducted by APHIS 
must be conducted at least annually by a representative of the 
government agency responsible for animal health in the region.
    (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

[[Page 567]]

agency responsible for animal health in the region of origin certifying 
that the conditions of paragraph (c)(1) through (c)(3) of this section 
have been met, except that, for shipments of animal feed from a region 
listed in Sec. 94.18(a)(3) of this subchapter, the certificate may be 
signed by a person authorized to issue such certificates by the 
veterinary services of the national government of the region of origin.
    (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) Tallow otherwise prohibited importation under paragraph (a)(1) 
of this section may be imported into the United States if it meets the 
following conditions:
    (1) The tallow is derived from bovines that have not been in a 
region listed in Sec. 94.18(a)(1) or (a)(2) of this subchapter;
    (2) The tallow is composed of less than 0.15 percent insoluble 
impurities;
    (3) After processing, the tallow was not exposed to or commingled 
with any other animal origin material; and
    (4) Each shipment to the United States is accompanied by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the region of origin, or issued by a veterinarian 
designated by or accredited by the national government of the region of 
origin and endorsed by a full-time salaried veterinary officer of the 
national government of the region of origin, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraphs (f)(1) 
through (f)(3) of this section have been met; and
    (5) The shipment, if arriving at a U.S. land border port, arrives at 
a port listed in Sec. 94.19(g) of this subchapter.

    Note to paragraph (f): The applicability of paragraph (f) to tallow 
derived from bovines that were 30 months of age or older when 
slaughtered is delayed indefinitely.

    (g) Offal that is otherwise prohibited importation under paragraph 
(a)(1) of this section may be imported if the offal is derived from 
cervids or the offal is derived from bovines, ovines, or

[[Page 568]]

caprines from a region listed in Sec. 94.18(a)(3) of this subchapter 
that have not been in a region listed in Sec. 94.18(a)(1) or (a)(2) of 
this subchapter, and the following conditions are met:
    (1) If the offal is derived from bovines, the offal:
    (i) Contains no SRMs and is derived from bovines from which the SRMs 
and small intestine were removed;
    (ii) Is derived from bovines for which an air-injected stunning 
process was not used at slaughter; and
    (iii) Is derived from bovines that are subject to a ruminant feed 
ban equivalent to the requirements established by the U.S. Food and Drug 
Administration at 21 CFR 589.2000;
    (2) If the offal is derived from ovines or caprines, the offal:
    (i) Is derived from ovines or caprines that were less than 12 months 
of age when slaughtered and that are from a flock or herd subject to a 
ruminant feed ban equivalent to the requirements established by the U.S. 
Food and Drug Administration at 21 CFR 589.2000;
    (ii) Is not derived from ovines or caprines that have tested 
positive for or are suspect for a transmissible spongiform 
encephalopathy;
    (iii) Is not derived from animals that have resided in a flock or 
herd that has been diagnosed with BSE; and
    (iv) Is derived from ovines or caprines whose movement was not 
restricted in the BSE minimal-risk region as a result of exposure to a 
transmissible spongiform encephalopathy.
    (3) Each shipment to the United States is accompanied by an original 
certificate signed by a full-time salaried veterinary officer of the 
national government of the region of origin, or issued by a veterinarian 
designated by or accredited by the national government of the region of 
origin and endorsed by a full-time salaried veterinary officer of the 
national government of the region of origin, representing that the 
veterinarian issuing the certificate was authorized to do so. The 
certificate must state that the requirements of paragraph (g)(1) or 
(g)(2) of this section have been met; and
    (4) The shipment, if arriving at a U.S. land border port, arrives at 
a port listed in Sec. 94.19(g) of this subchapter.

    Note to paragraph (g): The applicability of paragraph (g) to offal 
derived from bovines that were 30 months of age or older when 
slaughtered is delayed indefinitely.

    (h) Transit shipment of articles. Articles that are prohibited 
importation into the United States in accordance with this section may 
transit air and ocean ports in the United States for immediate export if 
the conditions of paragraphs (h)(1) through (h)(3) of this section are 
met. If such commodities are derived from bovines, sheep, or goats from 
a region listed inSec. 94.18(a)(3) of this subchapter, they are 
eligible to transit the United States by overland transportation if the 
requirements of paragraphs (h)(1) through (h)(4) of this section 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 
inspector at both the place in the United States where the articles will 
arrive and the port of export before such transit. The notification 
includes the following:
    (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 are eligible to enter the United States in 
accordance with this section and are accompanied by the certification 
required by this section. Additionally, the following conditions must be 
met:

[[Page 569]]

    (i) The shipment is exported from the United States within 7 days of 
its entry;
    (ii) The commodities are not transloaded while in the United States, 
except for direct transloading under the supervision of an inspector, 
who must break the seals of the national government of the region of 
origin on the means of conveyance that carried the commodities into the 
United States and seal the means of conveyance that will carry the 
commodities out of the United States with seals of the U.S. Government;
    (iii) A copy of the import permit required under paragraph (h)(2) of 
this section is presented to the inspector at the port of arrival and 
the port of export in the United States.

(Approved by the Office of Management and Budget under control numbers 
0579-0015 and 0579-0183)

[66 FR 42600, Aug. 14, 2001, as amended at 70 FR 552, Jan. 4, 2005; 70 
FR 12113, Mar. 11, 2005; 70 FR 71218, Nov. 28, 2005; 71 FR 12998, Mar. 
14, 2006]