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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. Page 2 of 5 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 Page 3 of 5 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 Page 4 of 5 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 Page 5 of 5 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).