[Federal Register Volume 66, Number 157 (Tuesday, August 14, 2001)]
[Rules and Regulations]
[Pages 42595-42601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20399]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 94 and 95

[Docket No. 00-121-1]
RIN 0579-AB26


Importation Prohibitions Because of Bovine Spongiform 
Encephalopathy

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Interim rule and request for comments.

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SUMMARY: We are amending the regulations to prohibit, with limited 
exceptions, the importation of certain animal materials and their 
derivatives, and any products they are used in, from regions considered 
to present an unacceptable risk of introducing bovine spongiform 
encephalopathy into the United States. Additionally, we are requiring 
that those materials, when imported from regions not considered at risk 
for bovine spongiform encephalopathy, be accompanied by government 
certification regarding the species, region of origin, processing, and 
handling of the materials and the animals from which they were derived. 
These actions are necessary to ensure that materials containing the 
bovine spongiform encephalopathy agent are not imported into the United 
States.

DATES: This rule is effective retroactively to December 7, 2000, except 
for Sec. 95.29, which is effective August 14, 2001. We invite you to 
comment on this docket. We will consider all comments that we receive 
by October 15, 2001.

ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 00-121-1, Regulatory Analysis and 
Development, PPD, APHIS, Suite 3C03, 4700 River Road, Unit 118, 
Riverdale, MD 20737-1238
    Please state that your comment refers to Docket No. 00-121-1.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/rad/webrepor.html.

FOR FURTHER INFORMATION CONTACT: Dr. Donna Malloy, Senior Staff 
Veterinarian, Technical Trade Services, National Center for Import and 
Export, VS, APHIS, 4700 River Road, Riverdale, MD 20737-1231; (301) 
734-3277.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to 
below as the regulations) govern the importation of certain animals, 
birds, poultry, meat, other animal products and byproducts, hay, and 
straw into the United States in order to prevent the introduction of 
various animal diseases, including bovine spongiform encephalopathy 
(BSE).
    BSE is a neurological disease of bovine animals and possibly other 
ruminants and is not known to exist in the United States.

[[Page 42596]]

    It appears that BSE is primarily spread through the use of ruminant 
feed containing certain protein products from ruminants infected with 
BSE. Currently, the U.S. Food and Drug Administration (FDA) regulations 
at 21 CFR 589.2000 prohibit the feeding of protein products that 
contain or may contain certain protein derived from mammalian tissues 
to cattle and other ruminants. However, BSE could be introduced into 
the United States if foreign-source protein materials carrying the BSE 
agent, such as meat, animal products, animal byproducts, and related 
materials are imported into the United States from regions where BSE 
exists, or from regions that present an undue risk of introducing BSE 
into the United States, and are ingested by cattle or other ruminants 
in the United States. BSE could also be introduced into the United 
States if ruminants from regions where BSE exists, or ruminants from 
regions that present an undue risk of introducing BSE into the United 
States, are imported into the United States.
    Sections 94.18, 95.4, and 96.2 of the regulations prohibit or 
restrict the importation of certain meat and other animal products and 
byproducts from ruminants that have been in regions where BSE exists or 
regions that present an undue risk of introducing BSE into the United 
States.
    In Sec. 94.18, paragraph (a)(1) contains a list of regions where 
BSE exists, while paragraph (a)(2) contains a list of regions that, 
because of import requirements less restrictive than those that would 
be acceptable for importation into the United States and/or because of 
inadequate surveillance, present an undue risk of introducing BSE into 
the United States. Together, the lists in Sec. 94.18(a)(1) and (a)(2) 
consist of all the countries of Europe and the country of Oman.
    Section 94.18 also prohibits the importation into the United States 
of certain products. Specifically, Sec. 94.18(b) prohibits the 
importation of fresh (chilled or frozen) meat, meat products, and 
edible products other than meat (excluding milk and milk products and, 
under certain conditions, gelatin) from ruminants that have been in any 
of the regions listed in Sec. 94.18(a).
    Section 95.4(a) of the regulations prohibits the importation of 
certain other products because of BSE. These products include--with 
certain exceptions for materials used in cosmetics and for materials 
transiting the United States for immediate export--bone meal, blood 
meal, meat meal, tankage, offal, fat, and glands from ruminants that 
have been in any region listed in Sec. 94.18(a). In this interim rule, 
we are adding materials to the list of prohibited products in 
Sec. 95.4(a). These amendments to the list in Sec. 95.4(a) are 
effective retroactively to December 7, 2000.

Additions to List of Prohibited Items

    With limited exceptions described below, the importation of the 
following materials, if derived from an animal that has been in any 
region listed in Sec. 94.18(a), is prohibited:
    1. Processed animal protein, offal, tankage, processed fats and 
oils, and tallow other than tallow derivatives, unless, in the opinion 
of the Administrator of the Animal and Plant Health Inspection Service 
(APHIS), the tallow cannot be used in feed, regardless of the animal 
species from which such materials are derived; and glands and 
unprocessed fat tissue derived from ruminants.
    2. Derivatives of processed animal protein, offal, and tankage, 
regardless of the species of origin; processed fats and oils, 
regardless of the species of origin; and derivatives of glands from 
ruminants.
    3. Products containing any of the materials included in items 1 or 
2 above.
    Additionally, we are prohibiting the importation of any of the 
types of materials included in items 1, 2, and 3 above, if the 
material:
     Originates in, or is stored, rendered, or otherwise 
processed in, a region listed in Sec. 94.18(a) as a region where BSE 
exists or that presents an undue risk of introducing BSE into the 
United States;
     Is otherwise associated with a facility located in a 
region listed in Sec. 94.18(a); or
     Is otherwise associated with any of the materials included 
in items 1, 2, or 3 above that have been in a region listed in 
Sec. 94.18(a).
    As noted above, the only regions currently listed in Sec. 94.18(a) 
are Oman and the countries of Europe.
    In this interim rule, we have also added a definition of processed 
animal protein to Sec. 95.1. We have defined that term to mean meat 
meal, bone meal, meat and bone meal, blood meal, dried plasma and other 
blood products, hydrolyzed proteins, poultry meal, feather meal, fish 
meal, and any other similar products.

Reasons for Additional Prohibitions

    We consider it necessary to expand the importation prohibitions in 
Sec. 95.4(a) to include certain products derived from animals other 
than ruminants because of the possibility that those products may have 
been cross-contaminated by products derived from ruminants.
    A ban on the feeding of ruminant products to other ruminants was 
enacted in the United Kingdom in 1988 and in certain other European 
countries in the early 1990's. A ban on the feeding of all mammalian 
products to ruminants was enacted in the European Union (EU) in 1994. 
However, several EU countries have identified cases of BSE in animals 
born after these bans were imposed. This has led to the conclusion 
among experts studying these cases that feed that was not prohibited by 
the bans was cross-contaminated by feed of ruminant origin. It appears 
likely that such cross-contamination occurred at facilities that 
process both prohibited and nonprohibited products.
    Opinions issued in July and November 2000 by the European 
Commission's (EC's) Scientific Steering Committee stated that such 
cross-contamination has prolonged the BSE epidemic in Europe. In 
December 2000, the EC announced a temporary prohibition on the feeding 
of processed animal protein to all farmed animals. This prohibition 
became effective on January 1, 2001.
    Because of the possibility that animal-based feeds or other 
processed animal proteins have been cross-contaminated by ruminant 
material, we have established (effective as of December 7, 2000) the 
prohibitions set forth in this interim rule to prohibit, with certain 
limited exceptions, the importation of the products described above 
under the heading ``Additions to List of Prohibited Items.'' We are 
taking this action on an emergency basis to help ensure that the BSE 
agent is not introduced into the United States. If, as further 
information becomes available to us, we determine that any of the 
prohibited products can be brought into the United States without risk 
of introducing the BSE agent into this country, we will initiate 
rulemaking to amend the regulations to allow the importation of those 
products, along with any conditions necessary to reduce the disease 
risk associated with such importations to a negligible level.

Tallow

    Prior to this interim rule, the regulations in Sec. 95.4 prohibited 
the importation of fat from ruminants that have been in any region 
listed in Sec. 94.18(a). We are clarifying in this interim rule that 
tallow--which, according to standard dictionary definition, is rendered 
fat--is included among the materials to which the prohibitions of 
Sec. 95.4 apply. However, we are excluding tallow derivatives from this 
prohibition, because such

[[Page 42597]]

products are so highly processed that it is highly unlikely they 
contain any protein. Further, we are not prohibiting all tallow, but 
only that tallow that is in a form that can be incorporated into feed, 
such as, but not limited to, bulk tallow. Generally, tallow is used for 
many industrial purposes, such as in soaps, candles, and lubricants for 
industrial equipment. These products would pose no risk of infecting 
animals in the United States with the BSE agent, and tallow in such 
forms will not be prohibited importation into the United States. 
However, we consider it necessary to prohibit the tallow if it could be 
used in feed of any type, because of the risk that tallow used in feed 
for animals other than ruminants might be diverted for use as ruminant 
feed.

Fat Tissue and Glands

    The prohibitions in this interim rule regarding the importation of 
glands and unprocessed fat tissue apply only if such materials are 
derived from ruminants; they do not apply to glands and unprocessed fat 
tissue derived from any other animal species. We do not consider it 
necessary to prohibit the importation of glands and unprocessed fat 
tissue from animal species other than ruminants because those articles 
are, by standard collection methods, not combined with any other 
materials. However, the prohibitions in this rule do apply to fat from 
any animal species if the fat has been processed in any way, because 
processed fat from various species may be commingled with or cross-
contaminated by processed fat from ruminants.

Exceptions for Materials From Certain Facilities

    With certain exceptions discussed in this supplementary 
information, we are applying the prohibitions contained in Sec. 95.4 to 
materials derived from all animal species because of the risk the 
materials could become cross-contaminated by materials derived from 
ruminants. However, in certain situations, we consider there to be a 
negligible risk that materials that would otherwise be prohibited 
importation by this interim rule will be cross-contaminated by 
materials derived from ruminants. In those situations, we do not 
consider it necessary to prohibit the importation of such materials.
    Specifically, the importation prohibition will not apply to 
materials if, prior to importation, the following conditions have been 
met:
    1. The materials are 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 the regulations.
    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 the regulations.
    3. The facility has 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.
    4. If the facility processes or handles any materials derived from 
mammals, the facility has entered into a cooperative service agreement 
executed by the operator of the facility and APHIS. Under that 
cooperative service agreement, the facility is current in paying all 
costs for a veterinarian of APHIS to inspect the facility (we 
anticipate that such inspections will occur approximately once per 
year), including travel, salary, subsistence, administrative overhead, 
and other incidental expenses (including excess baggage provisions of 
up to 150 pounds). Additionally, the facility has 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 foreign 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 conditions 1, 2, and 3, above, 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.)

Materials Used for Cosmetics and Insulin for Personal Use

    Animal-derived materials that are used for cosmetics will continue 
to be allowed importation into the United States under the existing 
conditions in Sec. 94.5, because such use should not allow the 
materials to come into contact with animals. For the same reason, we 
are adding a new Sec. 95.4(e), so as not to prohibit under Sec. 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). 
(Please note: We have determined that insulin for personal medical use 
that is imported in accordance with the regulations should not pose a 
risk to livestock. This does not imply endorsement of the safety of 
such insulin for human use. Further, importation of insulin for 
personal medical use may be prohibited by other Federal laws, including 
the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq., which 
is administered by the FDA.) A permit will continue to be required for 
the importation of materials to be used for cosmetics, and will also be 
required for the importation of insulin for personal medical use.

Certification Requirements

    We are also adding a new Sec. 95.29 to help ensure that products 
that are prohibited from being imported into the United States under 
Sec. 95.4(a) due to their origin are not moved to a country not listed 
in Sec. 94.18(a) and then to the United States. We are providing in new 
Sec. 95.29 that each shipment of the following material from any region 
not listed in Sec. 94.18(a) must be accompanied by an original 
certificate signed by a full-time salaried veterinarian of the agency 
responsible for animal health in the exporting region:
    1. Processed animal protein, offal, tankage, processed fats and 
oils, 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 such materials are derived; and glands 
and unprocessed fat tissue derived from ruminants.
    2. Derivatives of processed animal protein, offal, and tankage, 
regardless of the animal species from which the material is derived; 
and derivatives of glands from ruminants.
    3. Products containing any of the materials included in items 1 or 
2 above.
    The certification would have to include the following information:
     The animal species from which the material was derived;

[[Page 42598]]

     The region where any facility in which the material was 
processed is located;
     That the material was derived only from animals that have 
never been in any region listed in Sec. 94.18(a);
     That the material did not originate in, and was never 
stored, rendered, or otherwise processed in, a region listed in 
Sec. 94.18(a);
     That the material was not otherwise associated with a 
facility located in a region listed in Sec. 94.18(a), or with any 
materials included in items 1, 2, or 3, above, that have been in a 
region listed in Sec. 94.18(a).
    As part of our ongoing efforts to ensure that the BSE agent is not 
introduced into the United States, we are in the process of obtaining 
data from each of our trading partners regarding all of the factors 
that could contribute to the risk that a country or other region might 
contain animals or products contaminated with the BSE agent. If this 
information demonstrates that a particular country or region poses an 
unacceptable risk of introducing BSE into the United States, we will 
take action to restrict or prohibit animals and animal products from 
that country or region.
    Among the requirements that might be considered for imports would 
be certification by the exporting country that ruminant material 
imported into the United States comes from ruminants that have never 
been fed ruminant material from BSE-affected regions. At this time, 
evidence does not exist to indicate that countries from which imports 
are currently not restricted due to BSE pose enough of a risk to make 
such a certification requirement an effective or justifiable mitigation 
measure for exports from these countries. However, as part of our 
ongoing BSE-prevention program, we welcome comment from the public on 
the need for or effectiveness of such measures, as well as on any other 
issues related to mitigating the risk of the introduction of the BSE 
agent into the United States.

Nonsubstantive Changes

    We are making a nonsubstantive change to the definition of Animal 
and Plant Health Inspection Service in Sec. 95.1 to indicate that the 
acronym ``APHIS'' can be used in the regulations in place of the full 
name of the agency.
    Additionally, we are clarifying in Sec. 94.18(b) that the term 
``fresh meat'' as used in that paragraph means chilled or frozen meat. 
This clarification makes the wording in Sec. 94.18(b) consistent with 
the wording used elsewhere in part 94.

Emergency Action

    This rulemaking is necessary on an emergency basis to ensure that 
materials that contain the BSE agent are not imported into the United 
States. Under these circumstances, the Administrator has determined 
that prior notice and opportunity for public comment are contrary to 
the public interest and that there is good cause under 5 U.S.C. 553 for 
making this rule effective less than 30 days after publication in the 
Federal Register. We are making this action effective retroactively to 
December 7, 2000, except for the certification requirement of 
Sec. 95.29, which is effective upon publication. December 7, 2000, is 
the date APHIS issued a policy stating it had stopped issuing import 
permits for, and would prohibit the importation of, the materials 
covered by this interim rule. These effective dates are necessary to 
ensure that animal products containing the BSE agent are not imported 
into the United States.
    We will consider comments that are received within 60 days of 
publication of this rule in the Federal Register. After the comment 
period closes, we will publish another document in the Federal 
Register. The document will include a discussion of any comments we 
receive and any amendments we are making to the rule as a result of the 
comments.

Executive Order 12866 and Regulatory Flexibility Act

    This rule has been reviewed under Executive Order 12866. The rule 
has been determined to be significant for the purposes of Executive 
Order 12866 and, therefore, has been reviewed by the Office of 
Management and Budget.
    We are amending the regulations to prohibit, with limited 
exceptions, the importation into the United States of certain animal 
materials and their derivatives, and any products they are used in, if, 
because of origin, processing, or other handling, the item intended for 
importation presents an unacceptable risk of containing the BSE agent. 
The types of prohibited materials include: Processed animal protein 
(including poultry meal and fish meal), offal, tankage, processed fats 
and oils, and tallow (other than tallow derivatives), unless the tallow 
cannot be used in feed, regardless of the animal species from which 
such materials are derived; and glands and unprocessed fat tissue 
derived from ruminants.
    The following economic analysis provides a cost-benefit analysis as 
required by Executive Order 12866 and an analysis of the potential 
economic effects on small entities as required by the Regulatory 
Flexibility Act.
    As one major exception to the prohibitions imposed by this rule, we 
will allow the importation of materials derived from nonruminant 
species, or from ruminant species if the ruminants have never been in 
any region listed in Sec. 94.18(a) of the regulations, if 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 the regulations.
    Additionally, we are requiring that such materials imported from 
regions other than those in which BSE exists or that present an undue 
risk of introducing BSE into the United States be accompanied by 
government certification regarding the animal species of origin, 
processing, handling, and region of origin of the animals from which 
the materials were derived.
    Information on import levels is more readily available for some 
materials affected by this rule than for others. Our discussion of 
potential imports is based on data for the principal commodity 
categories expected to be affected. Additionally, we identify other 
potentially affected commodity categories.
    The principal commodity categories of prohibited items for which an 
assessment of imports from Europe is possible (none of these categories 
of commodities is imported from Oman) are the following: Powder and 
waste of bones; lard and other fat; flours, meals, and pellets 
containing meat or meat offal; flours, meals, and pellets containing 
fish or crustaceans; dog or cat food; and animal feed preparations 
other than dog or cat food. For each of these commodity categories 
except animal feed preparations other than dog or cat food, the 
percentage of U.S. imports supplied by Europe is minor--about 1 percent 
or less for lard and for flours, meals, and pellets made of meat or 
meat offal, and of fish or crustaceans; about 6 percent for powder and 
waste of bones and for dog or cat food. The average annual value, from 
1997 to 1999, of animal feed preparations other than dog or cat food 
that were supplied by Europe was about $49 million, and represented 
about 22 percent of such imports.
    About 18 percent of animal feed preparations imported by the United 
States, by value, is composed of prepared poultry and swine feed. These 
types of feed comprise about one-third of the animal feed preparations 
imported from Europe. (Other products used in animal feed preparations

[[Page 42599]]

include egg, milk, or vegetable products.)
    The United States is a net exporter of all of the above categories 
of commodities. For dog or cat food and for animal feed preparations 
other than dog or cat food--the two categories with the highest import 
volumes--annual import values were about 22 and 40 percent of export 
values, respectively.
    The relatively small value of dog or cat food and of other animal 
feed preparations imported from Europe is apparent when compared to the 
value of annual U.S. exports of these products. Imports from Europe 
comprise only about 0.1 percent of the value of U.S. exports of dog or 
cat food. For other animal feed preparations, imports from Europe are 
less than 0.3 percent of the value of U.S. exports.
    In addition to the principal commodity categories discussed above, 
it is possible there will be other items whose importation will be 
prohibited by this interim rule, such as certain other animal fat 
products and certain animal-derived substances used in medicament 
preparations. We are unable to identify affected products under these 
headings, nor the value of any such products supplied by Europe.
    The Regulatory Flexibility Act requires that agencies assess the 
potential economic effects of rules on small entities. Whether affected 
entities within a particular industry are considered small by the U.S. 
Small Business Association depends either on the number of employees or 
annual gross receipts. Two industries that will likely be affected are 
``dog and cat food manufacturing'' and ``other animal food 
manufacturing,'' for both of which the criterion for being considered a 
small entity is whether the establishment has 500 or fewer employees. 
The 1997 ``Economic Census'' reports that 186 of the 188 dog and cat 
food manufacturing establishments in the United States had 500 or fewer 
employees, and that all of the 1,514 establishments categorized as 
``other animal food manufacturing establishments'' had 500 or fewer 
employees.
    Other entities that may be affected by this rule are livestock 
producers who use nonruminant animal feed preparations that have been 
imported from Europe. U.S. dairy, beef, and hog producers are 
predominantly small entities, based on the criterion of having annual 
gross receipts of $500,000 or less. Cattle feedlot operations that 
could also be affected are predominantly small entities, based on the 
criterion of having annual gross receipts of $1.5 million or less.
    Although manufacturing establishments and agricultural firms that 
could be affected by this rule are predominantly small entities, the 
fact that very small volumes of the items prohibited under this interim 
rule are imported from Europe suggests that any effects will be 
similarly small. For manufacturers of dog or cat food and other animal 
feed preparations, imports from Europe are but a fraction of 1 percent 
of industry sales. Nonruminant lard imports and imports of animal feed 
preparations from Europe are also small compared to overall import 
levels. Additionally, although we are unable to assess at this time the 
possible effects of the provisions in this interim rule with regard to 
certain exceptions to the general prohibitions (e.g., for nonmammalian 
materials processed in a plant dedicated to processing only 
nonmammalian animal species), they can be expected to reduce any 
economic effects of this rule even further.
    For the commodities examined, some U.S. small entities are likely 
to be affected by this rule. However, the volumes imported from Europe 
suggest that a substantial number of entities will not be affected, and 
that those that are will not be affected significantly.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This rule has been reviewed under Executive Order 12988, Civil 
Justice Reform. This rule: (1) Preempts all State and local laws and 
regulations that are inconsistent with this rule; (2) has retroactive 
effect to December 7, 2000; and (3) does not require administrative 
proceedings before parties may file suit in court challenging this 
rule.

Paperwork Reduction Act

    In accordance with section 3507(j) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection and 
recordkeeping requirements included in this interim rule have been 
submitted for emergency approval to the Office of Management and Budget 
(OMB). OMB has assigned control number 0579-0183 to the information 
collection and recordkeeping requirements.
    We plan to request continuation of that approval for 3 years. 
Please send written comments on the 3-year approval request to the 
following addresses: (1) Office of Information and Regulatory Affairs, 
OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) 
Docket No. 00-121-1, Regulatory Analysis and Development, PPD, APHIS, 
suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please 
state that your comments refer to Docket No. 00-121-1 and send your 
comments within 60 days of publication of this rule.
    This interim rule prohibits the importation of certain animal 
materials into the United States because of the risk of the 
introduction of BSE into this country. Additionally, it requires that 
certain animal materials imported into the United States be accompanied 
by certification by the veterinary authorities of the national 
government of the country from which the materials are shipped 
regarding the origin and processing of the products. We are soliciting 
comments from the public, as well as affected agencies, concerning our 
information collection and recordkeeping requirements. These comments 
will help us:
    (1) Evaluate whether the information collection is necessary for 
the proper performance of our agency's functions, including whether the 
information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
information collection, including the validity of the methodology and 
assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 10 minutes per response.
    Respondents: Producers and importers of certain animal products.
    Estimated annual number of respondents: 1,000.
    Estimated annual number of responses per respondent: 9.
    Estimated annual number of responses: 9,000.
    Estimated total annual burden on respondents: 1,500 hours.
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

List of Subjects

9 CFR Part 94

    Animal diseases, Imports, Livestock, Poultry and poultry products,

[[Page 42600]]

Quarantine, Reporting and recordkeeping requirements.

9 CFR Part 95

    Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping 
requirements, Straw, Transportation.

    Accordingly, we are amending 9 CFR parts 94 and 95 as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, HOG 
CHOLERA, AND BOVINE SPONGIFORM ENCEPHALOPATHY; PROHIBITED AND 
RESTRICTED IMPORTATIONS

    1. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 450, 7711, 7712, 7713, 7714, 7751, and 7754; 
19 U.S.C. 1306; 21 U.S.C. 111, 114a, 134a, 134b, 134c, 134f, 136, 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.


Sec. 94.18  [Amended]

    2. In Sec. 94.18, paragraph (b) is amended by removing the words 
``fresh, frozen, and chilled'' and adding in their place the words 
``fresh (chilled or frozen)''.

PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS), 
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES

    3. The authority citation for part 95 continues to read as follows:

    Authority: 21 U.S.C. 111, 136, and 136a; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.4.


    4. In Sec. 95.1, the definition of Animal and Plant Health 
Inspection Service is revised and a new definition of processed animal 
protein is added, in alphabetical order, to read as follows:


Sec. 95.1  Definitions.

* * * * *
    Animal and Plant Health Inspection Service (APHIS) means the Animal 
and Plant Health Inspection Service of the United States Department of 
Agriculture.
* * * * *
    Processed animal protein means 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.
* * * * *

    5. Section 95.4 is revised to read as follow:


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;
    (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

[[Page 42601]]

region of export certifying that the 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)

    6. A new Sec. 95.29 is added to read as follows:


Sec. 95.29  Certification for certain materials.

    (a) In addition to meeting any other certification or permit 
requirements of this chapter, the following articles may be imported 
into the United States from any region not listed in Sec. 94.18(a) only 
if they are accompanied by a certificate, as described in paragraph (b) 
of this section:
    (1) 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 is derived;
    (2) Glands and unprocessed fat tissue derived from ruminants;
    (3) Processed fats and oils, and derivatives of processed animal 
protein, tankage, and offal, regardless of the animal species from 
which the material is derived;
    (4) Derivatives of glands from ruminants; and
    (5) Any product containing any of the materials listed in 
paragraphs (a)(1) through (a)(4) of this section.
    (b) The certificate required by paragraph (a) of this section must 
be an original official certificate, signed by a full-time, salaried 
veterinarian of the agency responsible for animal health in the 
exporting region, that states the following:
    (1) The animal species from which the material was derived;
    (2) The region in which any facility where the material was 
processed is located;
    (3) That the material was derived only from animals that have never 
been in any region listed in Sec. 94.18(a) of this chapter, with the 
regions listed in Sec. 94.18(a) specifically named;
    (4) That the material did not originate in, and was never stored 
in, rendered or processed in, or otherwise associated with a facility 
in a region listed in Sec. 94.18(a); and
    (5) The material was never associated with any of the materials 
listed in paragraph (a) of this section that have been in a region 
listed in Sec. 94.18(a).
    (c) The certification required by paragraph (a) of this section 
must clearly correspond to the shipment by means of an invoice number, 
shipping marks, lot number, or other method of identification.

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

    Done in Washington, DC, this 8th day of August 2001.
Bill Hawks,
Under Secretary for Marketing and Regulatory Programs.
[FR Doc. 01-20399 Filed 8-13-01; 8:45 am]
BILLING CODE 3410-34-P