Download Interim Rule Concerning Importation Prohibitions Because of Bovine

August 27, 2001
MEMORANDUM
RE: INTERIM RULE CONCERNING IMPORTATION PROHIBITIONS
BECAUSE OF BOVINE SPONGIFORM ENCEPHALOPATHY
On Tuesday, August 14, 2001, the United States Department of Agriculture Animal
and Plant Health Inspection Service (APHIS) published an interim rule entitled, “Importation
Prohibitions Because of Bovine Spongiform Encephalopathy,” and a request for comments. 66
Fed. Reg. 42595 (2001). The comment period for the interim regulation ends October 15,
2001. The regulation is primarily designed to codify the import restrictions APHIS adopted on
December 7, 2000 and most provisions of the rule are declared to be effective retroactively to
December 7. The rule also adds a new section 9 C.F.R. § 95.29, which sets certification
requirements for certain materials. The effective date of this section is August 14, 2001, the
date of publication.
Pre-existing regulation 9 C.F.R. § 94.18(b) prohibits the importation into the United
States of fresh, chilled, and frozen meat, meat products, and edible products other than meat
(excluding milk and milk products and, under certain conditions, gelatin) from ruminants that
had been in any country that has Bovine Spongiform Encephalopathy (“BSE”) or that APHIS
considers to present an undue risk of introducing BSE into the United States. These countries
are listed in 9 C.F.R. § 94.18(a) and include Oman and countries in Europe. Pre-existing
regulation 9 C.F.R. § 95.4(a) prohibited the importation of certain other materials derived from
ruminants that have been in any region listed in 9 C.F.R. § 94.18(a). The materials prohibited by
the pre-existing version of § 95.4(a) include bone meal, blood meal, meat meal, tankage, offal,
fat, and glands.1 The revised § 95.4(a), as adopted by the interim rule, restricts importation of
1
The rule excepts certain materials used in cosmetics or transiting the United States for immediate export.
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the following categories of materials and products made from those materials when the materials
are derived from animals that have been in a country listed in § 94.18(a):
Processed animal protein, offal, tankage, processed fats and oils, and tallow
other than tallow derivatives (unless APHIS concludes the tallow cannot be
used in feed) regardless of the animal species from which such materials are
derived; and from ruminants, unprocessed fat tissue, glands and derivatives of
glands.
“Processed animal protein” is defined by the new regulation to include meat meal, bone meal,
meat and bone meal, blood meal, dried plasma and other blood products, hydrolyzed proteins,
hoof meal, horn meal, poultry meal, feather meal, fish meal, and any other similar products.
Thus, the interim rule expands the prohibition against importation of ruminant-derived meat
meal, bone meal, and blood meal in the prior version of § 95.4(a) to cover the same types of
materials derived from any species. It also ads to the list of prohibited products dried plasma and
other blood products, hydrolyzed proteins, hoof meal, horn meal, poultry meal, feather meal, fish
meal, any other similar products, and processed fats and oils from any species and derivatives of
glands from ruminants. The rule also prohibits the importation of any of these materials if the
material is stored, rendered, or otherwise processed in a region listed in § 94.18(a); is otherwise
associated with a facility located in a region listed in § 94.18(a); or is otherwise associated with
any of the listed materials derived from animals that have been in a region listed in § 94.18(a).
Please note that the preamble description (66 Fed. Reg. at 42596) is not precise; the regulation is
broader than the description.
The interim rule additionally clarifies that the term “fresh meat” as used in 21 C.F.R.
§ 94.18(b) means chilled or frozen meat. The interim regulation does not otherwise change the
import restrictions of § 94.18, including the provisions permitting importation of gelatin under
the conditions specified in the regulation.
Pre-existing 9 C.F.R. § 95.4(a) prohibited the importation of fat from ruminants that have
been in any region listed in § 94.18. The interim rule “clarifies” this prohibition by stating that
tallow (rendered fat) is included among the prohibited material. The interim rule excludes tallow
derivatives, however, because such products are so highly processed that APHIS considers it to
be very unlikely that they contain any protein. Further, the rule only prohibits that tallow that is
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in a form that can be incorporated into feed, such as bulk tallow. APHIS states in the preamble
to the interim regulation that products made from tallow such as soaps, candles, and lubricants
for industrial equipment pose no risk of infecting animals in the United States with the BSE
agent, and the rule does not prohibit the importation of tallow in such forms. The interim
regulation also prohibits the importation of glands and unprocessed fat tissue from ruminants and
fat from any animal species if the fat has been processed in any way.
These prohibitions will not apply, however, to materials derived from a nonruminant
species, or from a ruminant species if the ruminants have never been in any region listed in
§ 94.18(a), provided that 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 § 94.18(a). The facility must have demonstrated
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. It must also allow periodic APHIS inspection of its facilities, records, and
operations. If the facility processes or handles any materials derived from mammals, moreover,
it must have entered into a cooperative service agreement with APHIS to cover the costs of
inspections by APHIS on what is anticipated to be an annual basis. An importation permit must
be issued for each such product and each shipment must be accompanied by an appropriate
veterinary certificate as described in the interim rule.
APHIS states in the preamble to the interim regulation that animal-derived materials that
are used for cosmetics will continue to be allowed importation into the United States under the
existing conditions in § 94.5, although the interim regulation expands the sources of collagen and
collagen products covered by the rule. It also adds a new § 95.4(e), which exempts from the
prohibitions of § 95.4(a) the importation of insulin for the personal medical use of the person
importing it (i.e., small quantities of ready-to-administer insulin). Import permits will continue
to be required for the importation of materials to be used for cosmetics, and will be required for
the importation of insulin for personal medical use.
APHIS has also added new § 95.29, which provides that each shipment of the following
materials from any region not listed in § 94.18(a) must be accompanied by a veterinary
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certificate identifying the animal species and the region where any facility in which the material
was processed is located: processed animal protein, offal, tankage, processed fats and oils, and
tallow (other than tallow derivatives and that which cannot be used in feed) regardless of the
animal species from which such materials are derived; and unprocessed fat tissue, glands and
derivatives of glands from ruminants. The certificate must additionally state that the animals
from which the materials were derived have never been in any region listed in § 94.18(a) and that
the materials did not originate in, and were never stored, rendered, or otherwise processed in, or
otherwise associated with such a facility located in a region listed in § 94.18(a). Finally, the
certificate must state that the materials were never associated with any of the types of material
listed above that have been in a region listed in § 94.18(a). This is a narrower certification than
the prohibition in § 95.4(a) of the interim rule, and possibly represents an inadvertent drafting
error.
According to one APHIS representative, the interim rule represents the codification of
the policy APHIS first adopted in December 2000. On December 19, 2000, APHIS posted a
“Statement” from its Administrator, Craig Reed, that “[a]s of December 7, 2000, the U.S.
Department of Agriculture has prohibited all imports of rendered animal protein products,
regardless of species, from Europe.” The Agency also generated a document on or about
December 15, 2000 stating that as of December 7, it had:
prohibited the importation of all processed animal proteins and products
derived from these proteins, regardless of species of origin, from countries
that are either affected by BSE or that have an unacceptably high risk for
BSE. The prohibited products include, but may not be limited to: meat and
bone meal (MBM), meat meal, bone meal, blood meal, protein meal, tankage,
offal, or any product containing such.
On January 18, 2001, APHIS issued a letter to stakeholders describing the “prohibited products”
as including meat and bone meal, meat meal, bone meal, blood meal, fish meal, poultry meal,
tankage, offal, fat, glands or any product containing such. Effective February 9, 2001, APHIS
suspended the importation of ruminant meat, meat products and other edible products that had
been stored, processed or otherwise associated with a facility located in Europe or Oman. It also
stated that other materials would not be eligible for entry until APHIS could verify that the
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materials had not been commingled or cross-contaminated with ruminant products from Europe
or Oman.
The interim rule is broader in scope than the import alerts discussed above in that it
covers processed fats and oils from non-ruminant species. The import alerts expressed the
import prohibitions in terms of rendered or processed animal proteins from non-ruminant species
or edible materials from ruminants. The interim rule made only non-substantive changes to
§ 94.18 and therefore did not change the provisions regarding importation of gelatin derived
from ruminants that have been in Europe or Oman.2
As explained above, the comment period for this interim regulation ends on
October 15, 2001. At some future point, APHIS would then issue a new “final” rule reflecting
comments received as well as other political, administrative and scientific developments.
COVINGTON & BURLING
www.cov.com
© 2001 Covington & Burling
2
Because the interim regulation does not amend 9 C.F.R. § 94.19, it also does not change the conditions
for importation of gelatin derived from horses or swine or from ruminants that have not been in a country
listed in 9 C.F.R. § 94.18(a).