Bovine Spongiform Encephalopathy; Minimal-Risk Regions, Identification of Ruminants and Processing and Importation of Commodities, 45439-45444 [E6-12944]
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Proposed Rules
research that supports any industry or
professional standards that pertain to
elephant care. We also invite data on the
costs and benefits associated with any
recommendations. We will consider all
comments and recommendations we
receive.
Authority: 7 U.S.C. 2131–2159; 7 CFR 2.22,
2.80, and 371.7.
Done in Washington, DC, this 3rd day of
August 2006.
W. Ron DeHaven,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. E6–12935 Filed 8–8–06; 8:45 am]
BILLING CODE 3410–34–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 93, 94, and 95
[Docket No. APHIS–2006–0026]
Bovine Spongiform Encephalopathy;
Minimal-Risk Regions, Identification of
Ruminants and Processing and
Importation of Commodities
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
jlentini on PROD1PC65 with PROPOSAL
AGENCY:
SUMMARY: In a final rule published in
the Federal Register on January 4, 2005,
we amended the regulations regarding
the importation of animals and animal
products to establish a category of
regions that present a minimal risk of
introducing bovine spongiform
encephalopathy (BSE) into the United
States via live ruminants and ruminant
products and byproducts, and we added
Canada to this category. We also
established conditions for the
importation of certain live ruminants
and ruminant products and byproducts
from such regions. In this document, we
are proposing to remove several
restrictions regarding the identification
of animals and the processing of
ruminant materials from BSE minimalrisk regions, as well as BSE-based
restrictions on gelatin derived from
bovine hides. We do not believe these
restrictions are necessary to prevent the
introduction of BSE into the United
States.
DATES: We will consider all comments
that we receive on or before October 10,
2006.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and, in the
lower ‘‘Search Regulations and Federal
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Actions’’ box, select ‘‘Animal and Plant
Health Inspection Service’’ from the
agency drop-down menu, then click on
‘‘Submit.’’ In the Docket ID column,
select APHIS–2006–0026 to submit or
view public comments and to view
supporting and related materials
available electronically. Information on
using Regulations.gov, including
instructions for accessing documents,
submitting comments, and viewing the
docket after the close of the comment
period, is available through the site’s
‘‘User Tips’’ link.
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. APHIS–2006–0026,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2006–0026.
Reading Room: 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.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For
information regarding ruminant
products, contact Dr. Karen JamesPreston, Director, Technical Trade
Services, Animal Products, National
Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38,
Riverdale, MD 20737–1231; (301) 734–
4356.
For information concerning live
ruminants, contact Lee Ann Thomas,
Director, Technical Trade Services,
Animals, Organisms and Vectors, and
Select Agents, National Center for
Import and Export, VS, APHIS, 4700
River Road Unit 38, Riverdale, MD
20737–1231; (301) 734–4356.
SUPPLEMENTARY INFORMATION:
Background
In a final rule published in the
Federal Register on January 4, 2005 (70
FR 460–553, Docket No. 03–080–3), we
amended the regulations regarding the
importation of animals and animal
products to establish a category of
regions that present a minimal risk of
introducing bovine spongiform
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45439
encephalopathy (BSE) into the United
States via live ruminants and ruminant
products and byproducts, and added
Canada to this category. We also
established conditions for the
importation of certain live ruminants
and ruminant products and byproducts
from such regions. These regulations are
in 9 CFR parts 93, 94, 95, and 96.
On November 28, 2005, we published
in the Federal Register an interim rule
(70 FR 71213–71218, Docket No. 03–
080–8) that (1) broadened who is
authorized to break the seals on a means
of conveyance carrying certain
ruminants from Canada and (2)
amended the regulations regarding the
transiting through the United States of
certain ruminant products from Canada
to allow for limited direct transloading
of the products from one means of
conveyance to another in the United
States.
On March 14, 2006, we published in
the Federal Register a technical
amendment (71 FR 12994–12998,
Docket No. 03–080–9) that clarified our
intent with regard to certain provisions
in the January 2005 final rule and
corrected several inconsistencies within
the rule.
In this proposed rule, we are
proposing to further amend the BSE
regulations to remove several
restrictions related to the provisions of
the January 2005 final rule that we
believe are unnecessary to prevent the
introduction of BSE from minimal-risk
regions into the United States. We
discuss those proposed changes below.
Means of Identification of Bovines,
Sheep, and Goats Imported From BSE
Minimal-Risk Regions
In our March 2006 technical
amendment, we clarified that it was the
intent of our January 2005 final rule that
all live bovines, sheep, and goats
imported from a BSE minimal-risk
region be accompanied by a health
certificate in accordance with § 93.405
and be individually identified in the
region of export before being shipped to
the United States. Because Canada was
the only country categorized as a BSE
minimal-risk region in our final rule,
and because the standard means of
individual livestock identification in
Canada is an eartag, we specified in
§ 93.436 of the final rule that live
bovines imported from a BSE minimalrisk region—in this case, Canada—must
be individually identified by means of
an official eartag of the country of
origin. The eartag must be determined
by the Administrator to meet standards
equivalent to those for official eartags in
the United States, as defined in 9 CFR
part 71, and to be traceable to the
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premises of origin of the animal. We
included a similar requirement in
§ 93.419(d)(2) for sheep and goats, but
because, even before our January 2005
final rule, § 93.419 referred only to
sheep and goats from Canada, we
specified that the sheep and goats must
be individually identified by an official
Canadian Food Inspection Agency
eartag.
We recognize that there are effective
means of individual identification other
than eartags. However, as stated above,
we provided in our January 2005 final
rule that the means of individual
identification must be an eartag because
eartags are the required means of
identification under Canada’s national
livestock identification program and
Canada was the only country we were
categorizing as a BSE minimal-risk
region in the final rule. We now
consider it advisable to amend the
regulations in a way that allows for
means of individual identification other
than eartags. This change would make it
clear to any other regions requesting
BSE minimal-risk status what we
consider acceptable with regard to
individual identification and would
give exporters the option of individually
identifying bovines, sheep, and goats
being exported to the United States by
means other than eartags.
Therefore, instead of requiring in
§ 93.436 that live bovines imported into
the United States from a BSE minimalrisk region must be individually
identified by means of an official eartag
of the country of origin, and instead of
requiring in § 93.419 that sheep and
goats imported into the United States
from Canada must be individually
identified by an official Canadian Food
Inspection Agency eartag, we are
proposing to provide instead in
§§ 93.419(c) and 93.436(a)(3) and (b)(4)
that the animals must be officially
identified with individual identification
before the animals’ arrival at the port of
entry into the United States. We are also
proposing to amend § 93.405(a)(4),
which currently requires that the health
certificate accompanying cattle, sheep,
or goats imported from a BSE minimalrisk region record the eartag required
under § 93.419 or § 93.436. We are
proposing to require instead that the
health certificate record the required
official identification.
We are proposing to define officially
identified in § 93.400 of the regulations
to mean ‘‘individually identified by
means of an official identification
device or method.’’ In § 93.400, official
identification device or method is
currently defined as a means of
officially identifying an animal or group
of animals using devices or methods
approved by the Administrator,
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including, but not limited to, official
tags, tattoos, and registered brands when
accompanied by a certificate of
inspection from a recognized brand
inspection authority.
We are not proposing to change that
wording. However, we are proposing to
add a sentence at the end of the
definition to make it clear that, for
animals intended for importation into
the United States, the particular device
or method of identification must have
been approved by the Administrator for
that type of import before the animal is
exported to the United States.
We are proposing to add that wording
in order to clarify that, although a
particular kind of identification may
have been approved by the
Administrator for use in particular
situations or for particular types of
animals, that doesn’t necessarily mean it
can be used for all types of animals and
in all situations. For instance, due to an
animal’s anatomy, it might not be
possible to affix certain types of tags to
the animal in a way that ensures the tags
will not fall off. As another example,
although the current definition of
official identification device or method
includes ‘‘registered brands’’ as an
example of such identification, a brand
in itself might not provide adequate
identification with regard to BSE.
Although a registered brand would
enable traceback of an animal to its herd
of origin, in the case of BSE form of
identification that provides more
detailed information about an
individual cow, such as an eartag,
would be necessary.
In the event that an importer or
importing country seeks and is granted
approval to use a device or method of
identification other than one
specifically provided for in the
regulations, the record of that approval
and the requirements, if any, for that
device or method will be included in
the protocol for imports from the
exporting region, which will be made
available on the APHIS Web site at
https://www.aphis.usda.gov/vs/ncie.
Hide-Derived Gelatin
The regulations at § 94.18(c) address
the importation of gelatin derived from
ruminants from regions listed in
§ 94.18(a) as regions in which BSE exists
(§ 94.18(a)(1)), regions that present an
undue risk of introducing BSE into the
United States (§ 94.18(a)(2)), and BSE
minimal-risk regions (§ 94.18(a)(3)).
With certain specified exceptions,
§ 94.18(c) prohibits the importation of
gelatin derived from ruminants that
have been in any region listed in
§ 94.18(a). One of the exceptions is for
gelatin derived from the bones of
bovines subject to a ruminant feed ban
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equivalent to the requirements
established by the U.S. Food and Drug
Administration at 21 CFR 589.2000 and
from which specified risk materials
(SRMs) and small intestine were
removed. We set forth the conditions for
that exception in § 94.19(f) of the
January 2005 final rule.
As currently written, the exception in
§ 94.19(f) applies exclusively to gelatin
derived from the bones of bovines and
not to gelatin derived from bovine
hides, even the hides of the same
bovines whose bones are used for
gelatin that is allowed importation into
the United States. However, we believe
there is no scientific reason to prohibit
the importation of gelatin derived from
the hides of bovines. Bovine hides have
not demonstrated BSE infectivity, even
in infected animals. The safety of bovine
hides with regard to BSE is recognized
internationally. The World Organization
for Animal Health (commonly referred
to as the OIE) recommends in Article
2.3.13.1 of the OIE Terrestrial Animal
Health Code, 2005, that gelatin derived
exclusively from the hides of bovines
not be subject to import restrictions. The
European Commission Scientific
Steering Committee’s Updated Opinion
on the Safety with Regard to TSE Risk
of Gelatine Derived from Ruminant
Bones or Hides (adopted by the
Scientific Steering Committee at its
December 5–6, 2002, meeting) states in
section B(c) of that document:
‘‘When ruminant hides are used for the
production of gelatine, they are usually
obtained from bovines. On the basis of
current knowledge, it can be considered that
the parts of the bovine hides used for the
production of gelatine do not present a risk
with regard to TSE’s [transmissible
spongiform encephalopathies, which include
BSE], provided contamination with
potentially infected materials is avoided.’’
Although APHIS considers gelatin
derived from bovine hides a commodity
that does not present a risk of
transmitting the BSE agent, by oversight
we did not include in our January 2005
final rule such gelatin as an exception
to the general prohibition on the
importation of gelatin derived from
ruminants from BSE minimal-risk
regions. Because there appears to be no
scientific reason to prohibit the
importation of such gelatin from BSE
minimal-risk regions, we are proposing
to amend § 94.19(f) to add that gelatin
derived from the hides of bovines that
have been in any region listed in
§ 94.18(a)(3) may be imported into the
United States. In order to help ensure
that such gelatin is not contaminated
with the BSE agent, we are also
proposing as a condition for such
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importation that the gelatin was not
commingled with materials ineligible
for entry into the United States. We
would also apply the non-commingling
requirement to gelatin derived from
bones from bovines from BSE minimalrisk regions. Such gelatin is already
allowed importation, with specified
conditions, under § 94.19(f).
Nonruminant Material
The regulations in § 95.4 prohibit the
importation of certain materials derived
from nonruminants, as well as materials
derived from ruminants. Specifically,
the following nonruminant materials
may not be imported into the United
States from regions listed in § 94.18(a)—
or be derived from nonruminant
animals that have been in a region listed
in § 94.18(a)—unless certain conditions
are met:
• Processed animal protein, tankage,
and offal;
• Tallow other than tallow
derivatives, unless, in the opinion of the
Administrator, the tallow cannot be
used in feed; and
• Processed fats and oils, and
derivatives of processed animal protein,
tankage, and offal.
Among the conditions for the
importation of these nonruminant
materials is that all steps of processing
and storing the material must have been
carried out in a foreign facility that has
not been used for the processing and
storage of materials from ruminants that
have been in any region listed in
§ 94.18(a). The purpose of this
requirement is to eliminate the
possibility that the nonruminant
material could become commingled
with or contaminated by ruminant
material containing the BSE agent and
therefore itself become contaminated
with the BSE agent.
We continue to consider this
restriction necessary with regard to
nonruminant materials that are
processed in regions listed in
§ 94.18(a)(1) or (2) (regions in which
BSE exists and regions that present an
undue risk of introducing BSE into the
United States). However, requiring that
nonruminant materials be processed in
separate facilities from ruminant
materials in BSE minimal-risk regions is
inconsistent with other provisions in
our January 2005 final rule. Therefore,
we are proposing to eliminate that
inconsistency, for the reasons explained
below.
Our January 2005 final rule allowed
the importation of certain ruminant
meat, products, and byproducts from
Canada (at this time Canada is the only
region recognized by APHIS as a BSE
minimal-risk region). APHIS determined
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that such commodities present a low
risk of introducing BSE into the United
States, based on a number of factors.
These factors include the measures
Canada has in place to detect and
prevent BSE within Canadian cattle and
the commodity-specific mitigation
measures in the final rule. For meat
(including whole or half carcasses),
meat byproducts, and meat food
products derived from bovines, the
regulations require that the bovines be
subject to a ruminant feed ban, prohibit
the use of an air-injected stunning
process at slaughter, and require that
SRMs and the small intestine of the
bovines be removed at slaughter.
Research has shown that BSE infectivity
in infected bovines is localized in
specific tissues, and removal of SRMs is
an effective risk mitigation measure for
bovines. Therefore, the regulations do
not require that bovine meat eligible for
entry into the United States from a BSE
minimal-risk region be processed in a
facility that processes only bovine
commodities eligible for entry into the
United States.1
In sheep and goats, research has not
identified SRMs that could be removed
to eliminate any potential infectivity
from infected animals. Infectivity has
not been demonstrated in most tissues
in sheep and goats until at least 16months post-exposure to the BSE agent.
Therefore, for meat (including whole or
half carcasses), meat byproducts, and
meat food products from sheep or goats
or other ovines or caprines, the
regulations require that the animals,
among other things, be less than 12
months of age when slaughtered and be
slaughtered at a facility that either
slaughters only sheep and/or goats or
other ovines and caprines less than 12
months of age or complies with a
segregation process approved by the
national veterinary authority of the
region of origin and the Administrator
as adequate to prevent contamination or
commingling of the meat with products
1 Pursuant to an announcement by the Secretary
of Agriculture on February 9, 2005, APHIS
published in the Federal Register on March 11,
2005, a document (70 FR 12112–12113, Docket No.
03–080–6) delaying until further notice the
applicability of the provisions of the final rule as
they apply to the importation from Canada of
certain commodities derived from bovines 30
months of age or older. While the delay in
applicability is in effect, commodities from Canada
derived from bovines less than 30 months of age
when slaughtered will be required to be processed
in an establishment that operates in compliance
with an approved Canadian Food Inspection
Agency program to prevent commingling of
ruminant products eligible for export to the United
States with ruminant products ineligible for export
to the United States. This is to ensure that only
products from bovines less than 30 months of age
are exported to the United States, however; not to
prevent contamination.
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not eligible for importation into the
United States.
In both cases, however—for products
derived from bovines and for products
derived from sheep or goats—the
regulations do not require that the
animals necessarily be slaughtered in a
facility dedicated only to ruminant
products eligible for entry into the
United States. Because products derived
from nonruminants pose even less of a
BSE risk than those derived from
ruminants, it is inconsistent with the
January 2005 final rule to require in
§ 95.4 that, in a region listed in
§ 94.18(a)(3) (i.e., a BSE minimal-risk
region), all steps of processing
nonruminant protein, tankage, offal, and
tallow other than tallow derivatives, as
well as processed fats and oils, and
derivatives of processed animal protein,
tankage, and offal derived from
nonruminants, be carried out in a
facility that has not been used for the
processing and storage of materials from
ruminants that have been in any region
listed in § 94.18(a)(3) (a BSE minimalrisk region). Therefore, we are proposing
to amend § 95.4 by adding a new
paragraph (c)(3) to require that, for
facilities in regions listed in
§ 94.18(a)(3), steps of processing and
storing the nonruminant material are
carried out in a 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)(1) or (a)(2).
Executive Order 12866 and Regulatory
Flexibility Act
This rule has been reviewed under
Executive Order 12866. The rule has
been determined to be not significant for
the purposes of Executive Order 12866
and, therefore, has not been reviewed by
the Office of Management and Budget.
The Regulatory Flexibility Act
requires agencies to evaluate the
potential effects of their proposed and
final rules on small businesses, small
organizations, and small governmental
jurisdictions. We have prepared an
initial regulatory flexibility analysis,
which is set forth below.
In a final rule published in January
2005, we established a category of
regions that present a minimal risk of
introducing BSE into the United States
via live ruminants and ruminant
products and byproducts, and added
Canada to this category. We also
established conditions for the
importation of certain live ruminants
and ruminant products and byproducts
from such regions.
In this proposed rule, we are
proposing to remove certain restrictions
on imports from BSE minimal-risk
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regions that concern animal
identification, the derivation of bovine
gelatin, and the processing of ruminant
and nonruminant materials. We do not
believe these restrictions are necessary
to prevent the introduction of BSE into
the United States.
Instead of limiting the type of
allowable individual identification on
bovines, sheep, and goats imported from
a BSE minimal-risk region to an official
eartag of the country of origin, we are
proposing to allow individual
identification of animals by means other
than eartags, provided the APHIS
Administrator has approved the manner
of identification for the type of animal
intended for importation.
Instead of limiting the importation of
bovine-derived gelatin from BSE
minimal-risk regions to gelatin derived
from bones, we are proposing to also
allow the importation of hide-derived
gelatin, provided certain conditions are
met.
We are also proposing to allow
nonruminant material that is processed
in BSE minimal-risk regions—such as
processed animal protein, tankage, offal,
certain tallow, processed fats and oils,
and derivatives of processed animal
protein, tankage, and offal—to be
processed in facilities that also process
material derived from ruminants from
the minimal-risk region.
We address below the potential
economic effect of each of these
changes.
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Animal Identification
Giving owners of bovines, sheep, and
goats in BSE minimal-risk regions the
option of individually identifying
animals being exported to the United
States by means other than eartags is not
expected to affect U.S. small entities.
This amendment simply acknowledges
that there are effective means of
individual identification other than
eartags. However, APHIS welcomes
information that the public may offer on
ways this amendment may impact small
entities, and the type and number of
small entities that would be affected.
Hide-Derived Gelatin
This amendment, by allowing the
importation of gelatin derived from
bovine hides, in addition to gelatin
derived from bovine bones, could affect
U.S. entities by providing for an
additional source of gelatin imported
from Canada.
Gelatin is derived from collagen, an
insoluble fibrous protein that is the
principal constituent of connective
tissues and bones. The main raw
materials used in gelatin production are
cattle bones, cattle hides, and porkskins.
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Gelatin recovered from bone is used
primarily in photographic applications.
Porkskin is currently the most
significant raw material source for
production of edible gelatin in North
America. Cattle hides are the least used
raw material for gelatin in North
America today. Cattle hides sourced by
member companies of the Gelatin
Manufacturers Institute of America for
the production of gelatin for food use
are purchased from a small number of
tanneries in the United States.
We do not have information about the
quantity of hide-derived gelatin that
would be imported from Canada
because of this proposed rule, nor do we
have an estimate of the number of U.S.
small entities that would be affected.
Production of animal hides is classified
by the North American Industry
Classification System (NAICS) under
‘‘Animal (except Poultry) Slaughtering’’
(NAICS 311611), for which the small
entity definition is businesses with not
more than 500 employees. We welcome
information that would allow us to
better understand the number and size
of entities that could be affected by
allowing the importation of hidederived bovine gelatin from Canada, and
the extent of the possible impact.
Nonruminant Material
This amendment would remove the
requirement that nonruminant material
that is processed in BSE minimal-risk
regions be processed in a facility that
does not also process material derived
from ruminants from the minimal-risk
region. If this amendment were to result
in changes in the amounts of
nonruminant material imported by the
United States, then U.S. entities could
be affected. Affected nonruminant
material may include processed animal
protein, tankage, offal, certain tallow,
processed fats and oils, and derivatives
of processed animal protein, tankage,
and offal.
Facilities that produce these
commodities are classified under
‘‘Rendering and Meat By-product
Processing’’ (NAICS 311613), for which
the small entity definition is businesses
with not more than 500 employees. We
do not have a basis for estimating the
change in imports of Canadian
nonruminant materials that may result
from the proposed rule, nor do we know
the number or size of U.S. entities that
would be affected. APHIS welcomes
information that the public may provide
regarding the number of small entities
that could be affected and the likely
magnitude of the effect.
APHIS has not identified any Federal
rules that may duplicate, overlap, or
conflict with this proposed rule, and
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believes there are no significant
alternatives to this proposed rule that
would accomplish the stated objectives.
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) All State and local laws and
regulations that are inconsistent with
this rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) administrative proceedings
will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new
information collection or recordkeeping
requirements under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects
9 CFR Part 93
Animal diseases, Imports, Livestock,
Poultry and poultry products,
Quarantine, Reporting and
recordkeeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock,
Meat and meat products, Milk, Poultry
and poultry products, Reporting and
recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports,
Livestock, Reporting and recordkeeping
requirements, Straw, Transportation.
Accordingly, we are proposing to amend
9 CFR parts 93, 94, and 95 as follows:
PART 93—IMPORTATION OF CERTAIN
ANIMALS, BIRDS, AND POULTRY,
AND CERTAIN ANIMAL, BIRD, AND
POULTRY PRODUCTS;
REQUIREMENTS FOR MEANS OF
CONVEYANCE AND SHIPPING
CONTAINERS
1. The authority citation for part 93
would continue to read as follows:
Authority: 7 U.S.C. 1622 and 8301–8317;
21 U.S.C. 136 and 136a; 31 U.S.C. 9701; 7
CFR 2.22, 2.80, and 371.4.
2. Section 93.400 would be amended
by revising the definition of official
identification device or method and
adding a definition of officially
identified, in alphabetical order, to read
as follows:
§ 93.400
Definitions.
*
*
*
*
*
Official identification device or
method. A means of officially
identifying an animal or group of
animals using devices or methods
E:\FR\FM\09AUP1.SGM
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Proposed Rules
approved by the Administrator,
including, but not limited to, official
tags, tattoos, and registered brands when
accompanied by a certificate of
inspection from a recognized brand
inspection authority. For animals
intended for importation into the United
States, the device or method of
identification used must have been
approved by the Administrator for that
type of import before the animal is
exported to the United States.
*
*
*
*
*
Officially identified. Individually
identified by means of an official
identification device or method.
*
*
*
*
*
3. In § 93.405, paragraph (a)(4) would
be amended by removing the word
‘‘eartag’’ and adding in its place the
words ‘‘official identification.’’
4. Section 93.419 would be amended
by revising paragraph (c), introductory
text, and paragraphs (d)(2), (d)(5),
(d)(7)(i), and (d)(7)(iii) to read as
follows:
§ 93.419
Sheep and goats from Canada.
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*
*
*
*
*
(c) Any sheep or goats imported from
Canada must not be pregnant, must be
less than 12 months of age when
imported into the United States and
when slaughtered, must be 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, and
must be officially identified with
individual identification before the
animal’s arrival at the port of entry into
the United States. No person may alter,
deface, remove, or otherwise tamper
with the official identification while the
animal is in the United States or moving
into or through the United States, except
that the identification may be removed
at the time of slaughter. The animals
must be accompanied by the
certification issued in accordance with
§ 93.405 that states, in addition to the
statements required by § 93.405, that the
conditions of this paragraph have been
met. Additionally, for sheep and goats
imported for other than immediate
slaughter, the certificate must state that
the conditions of paragraph (d)(1) of this
section have been met. For sheep and
goats imported for immediate slaughter,
the certificate must also state that:
*
*
*
*
*
(d) * * *
(2) The animals may be moved from
the port of entry only to a feedlot
designated in accordance with
paragraph (d)(7) of this section and must
be accompanied from the port of entry
to the designated feedlot by APHIS
VerDate Aug<31>2005
18:06 Aug 08, 2006
Jkt 208001
Form VS 17–130 or other movement
documentation deemed acceptable by
the Administrator, which must identify
the physical location of the feedlot, the
individual responsible for the
movement of the animals, and the
individual identification of each animal,
which includes the official
identification required under paragraph
(c) of this section and any other
identification present on the animal,
including registration number, if any:
*
*
*
*
*
(5) The animals must be accompanied
to the recognized slaughtering
establishment by APHIS Form VS 1–27
or other documentation deemed
acceptable by the Administrator, which
must identify the physical location of
the recognized slaughtering
establishment, the individual
responsible for the movement of the
animals, and the individual
identification of each animal, which
includes the official identification
required under paragraph (c) of this
section and any other identification
present on the animal, including
registration number, if any;
*
*
*
*
*
(7) * * *
(i) Will not remove official
identification from animals unless
medically necessary, in which case new
official identification will be applied
and cross referenced in the records;
*
*
*
*
*
(iii) Will maintain records of the
acquisition and disposition of all
imported sheep and goats entering the
feed lot, including the official
identification number and all other
identifying information, the age of each
animal, the date each animal was
acquired and the date each animal was
shipped to slaughter, and the name and
location of the plant where each animal
was slaughtered. For Canadian animals
that die in the feedlot, the feedlot will
remove the official identification device
if affixed to the animal, or will record
any other official identification on the
animal and place the official
identification device or record of official
identification in a file with a record of
the disposition of the carcass;
*
*
*
*
*
5. Section 93.436 would be amended
as follows:
a. Paragraphs (a)(3) and (b)(4) would
be revised to read as set forth below.
b. In paragraphs (b)(8) and (b)(11), the
word ‘‘eartag’’ would be removed and
the words ‘‘official identification’’
would be added in its place.
PO 00000
Frm 00007
Fmt 4702
Sfmt 4702
45443
§ 93.436 Ruminants from regions of
minimal risk for BSE.
*
*
*
*
*
(a) * * *
(3) Each bovine must be officially
identified with individual identification
before the animal’s arrival at the port of
entry into the United States. No person
may alter, deface, remove, or otherwise
tamper with the official identification
while the animal is in the United States
or moving into or through the United
States, except that the identification
may be removed at slaughter;
*
*
*
*
*
(b) * * *
(4) Each bovine must be officially
identified with individual identification
before the animal’s arrival at the port of
entry into the United States. No person
may alter, deface, remove, or otherwise
tamper with the official identification
while the animal is in the United States
or moving into or through the United
States, except that the identification
may be removed at slaughter;
*
*
*
*
*
PART 94—RINDERPEST, FOOT-ANDMOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE
DISEASE, AFRICAN SWINE FEVER,
CLASSICAL SWINE FEVER, AND
BOVINE SPONGIFORM
ENCEPHALOPATHY: PROHIBITED
AND RESTRICTED IMPORTATIONS
6. The authority citation for part 94
would continue to read as follows:
Authority: 7 U.S.C. 450, 7701–7772, 7781–
7786, and 8301–8317; 21 U.S.C. 136 and
136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and
371.4.
7. In § 94.19, paragraph (f) would be
revised to read as follows:
§ 94.19 Restrictions on importation from
BSE minimal-risk regions of meat and
edible products from ruminants.
*
*
*
*
*
(f) Gelatin other than that allowed
importation under § 94.18(c). The
gelatin is derived from:
(1) The bones of bovines subject to a
ruminant feed ban equivalent to the
requirements established by the U.S.
Food and Drug Administration at 21
CFR 589.2000 and from which SRMs
and small intestine were removed, and
the gelatin has not been commingled
with materials ineligible for entry into
the United States; or
(2) The hides of bovines, and the
gelatin has not been commingled with
materials ineligible for entry into the
United States.
*
*
*
*
*
E:\FR\FM\09AUP1.SGM
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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Proposed Rules
PART 95—SANITARY CONTROL OF
ANIMAL BYPRODUCTS (EXCEPT
CASINGS), AND HAY AND STRAW,
OFFERED FOR ENTRY INTO THE
UNITED STATES
Done in Washington, DC, this 3rd day of
August 2006.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. E6–12944 Filed 8–8–06; 8:45 am]
8. The authority citation for part 95
would continue to read as follows:
BILLING CODE 3410–34–P
Authority: 7 U.S.C. 8301–8317; 21 U.S.C.
136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22,
2.80, and 371.4.
9. Section 95.4 would be amended as
follows:
a. Paragraph (c)(2) would be revised to
read as set forth below.
b. Paragraphs (c)(3) through (c)(7)
would be redesignated as paragraphs
(c)(4) through (c)(8), respectively.
c. A new paragraph (c)(3) would be
added to read as set forth below.
d. Newly designated paragraph (c)(7)
would be revised to read as set forth
below.
jlentini on PROD1PC65 with PROPOSAL
§ 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.
(c) * * *
(2) Except for material processed or
stored in regions listed in § 94.18(a)(3)
of this subchapter, all steps of
processing and storing the material are
carried out in a 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) of this subchapter.
(3) For material processed or stored in
regions listed in § 94.18(a)(3) of this
subchapter, all steps of processing and
storing the material are carried out in a
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)(1) or
(a)(2) of this subchapter.
*
*
*
*
*
(7) 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
conditions of paragraphs (c)(1) through
(c)(4) of this section have been met;
except that, for shipments of animal
feed from a region listed in § 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.
*
*
*
*
*
VerDate Aug<31>2005
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Jkt 208001
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Part 98
[Docket No. APHIS–2006–0120]
Importation of Sheep and Goat Semen
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
SUMMARY: We are proposing to amend
the regulations regarding the
importation of animal germplasm by
removing specific restrictions on sheep
semen from regions where scrapie exists
and requiring the inclusion of
additional information on the
international health certificate
accompanying sheep and goat semen.
Experience and research have
convinced us that sheep and goat semen
pose a minimal risk of transmitting
scrapie. This action would relieve
restrictions on imported sheep semen
while continuing to provide safeguards
against the introduction and
dissemination of scrapie.
DATES: We will consider all comments
that we receive on or before October 10,
2006.
ADDRESSES: You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov and, in the
lower ‘‘Search Regulations and Federal
Actions’’ box, select ‘‘Animal and Plant
Health Inspection Service’’ from the
agency drop-down menu, then click on
‘‘Submit.’’ In the Docket ID column,
select APHIS–2006–0120 to submit or
view public comments and to view
supporting and related materials
available electronically. Information on
using Regulations.gov, including
instructions for accessing documents,
submitting comments, and viewing the
docket after the close of the comment
period, is available through the site’s
‘‘User Tips’’ link.
• Postal Mail/Commercial Delivery:
Please send four copies of your
comment (an original and three copies)
to Docket No. APHIS–2006–0120,
Regulatory Analysis and Development,
PPD, APHIS, Station 3A–03.8, 4700
River Road Unit 118, Riverdale, MD
PO 00000
Frm 00008
Fmt 4702
Sfmt 4702
20737–1238. Please state that your
comment refers to Docket No. APHIS–
2006–0120.
Reading Room: 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.
Other Information: Additional
information about APHIS and its
programs is available on the Internet at
https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Arnaldo Vaquer, Senior Staff
Veterinarian, Technical Trade Services,
National Center for Import and Export,
VS, APHIS, 4700 River Road Unit 39,
Riverdale, MD 20737–1231; (301) 734–
8074.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 98
govern the importation of animal
germplasm to prevent the introduction
of contagious diseases of livestock and
poultry into the United States. Subparts
A and B of part 98 apply to animal
embryos, and subpart C (§§ 98.30
through 98.38, referred to below as the
regulations) applies to animal semen.
Currently, the regulations in § 98.37
restrict, due to scrapie concerns, the
importation of sheep semen into the
United States from any region of the
world other than Australia, Canada, and
New Zealand. These restrictions include
provisions that the semen must be
transferred only to females in a U.S.
flock that is participating in the
voluntary Scrapie Flock Certification
Program (SFCP), that the semen must
originate from a donor animal
participating in a program equivalent to
the SFCP or the SFCP flock status must
be lowered, and that the semen must be
accompanied by a certificate attesting to
the above conditions. The importer is
also required to provide the Animal and
Plant Health Inspection Service (APHIS)
with information concerning control
programs, surveillance, and disease
incidence in the exporting region, as
well as information concerning the
health status of other ruminants in the
region.
The regulations in § 98.35 deal with
declarations, health certificates, and
other documents required for the
importation of all animal semen into the
United States. All animal semen
E:\FR\FM\09AUP1.SGM
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Agencies
[Federal Register Volume 71, Number 153 (Wednesday, August 9, 2006)]
[Proposed Rules]
[Pages 45439-45444]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-12944]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 93, 94, and 95
[Docket No. APHIS-2006-0026]
Bovine Spongiform Encephalopathy; Minimal-Risk Regions,
Identification of Ruminants and Processing and Importation of
Commodities
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In a final rule published in the Federal Register on January
4, 2005, we amended the regulations regarding the importation of
animals and animal products to establish a category of regions that
present a minimal risk of introducing bovine spongiform encephalopathy
(BSE) into the United States via live ruminants and ruminant products
and byproducts, and we added Canada to this category. We also
established conditions for the importation of certain live ruminants
and ruminant products and byproducts from such regions. In this
document, we are proposing to remove several restrictions regarding the
identification of animals and the processing of ruminant materials from
BSE minimal-risk regions, as well as BSE-based restrictions on gelatin
derived from bovine hides. We do not believe these restrictions are
necessary to prevent the introduction of BSE into the United States.
DATES: We will consider all comments that we receive on or before
October 10, 2006.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to https://
www.regulations.gov and, in the lower ``Search Regulations and Federal
Actions'' box, select ``Animal and Plant Health Inspection Service''
from the agency drop-down menu, then click on ``Submit.'' In the Docket
ID column, select APHIS-2006-0026 to submit or view public comments and
to view supporting and related materials available electronically.
Information on using Regulations.gov, including instructions for
accessing documents, submitting comments, and viewing the docket after
the close of the comment period, is available through the site's ``User
Tips'' link.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. APHIS-
2006-0026, Regulatory Analysis and Development, PPD, APHIS, Station 3A-
03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state
that your comment refers to Docket No. APHIS-2006-0026.
Reading Room: 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.
Other Information: Additional information about APHIS and its
programs is available on the Internet at https://www.aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT: For information regarding ruminant
products, contact Dr. Karen James-Preston, Director, Technical Trade
Services, Animal Products, National Center for Import and Export, VS,
APHIS, 4700 River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-
4356.
For information concerning live ruminants, contact Lee Ann Thomas,
Director, Technical Trade Services, Animals, Organisms and Vectors, and
Select Agents, National Center for Import and Export, VS, APHIS, 4700
River Road Unit 38, Riverdale, MD 20737-1231; (301) 734-4356.
SUPPLEMENTARY INFORMATION:
Background
In a final rule published in the Federal Register on January 4,
2005 (70 FR 460-553, Docket No. 03-080-3), we amended the regulations
regarding the importation of animals and animal products to establish a
category of regions that present a minimal risk of introducing bovine
spongiform encephalopathy (BSE) into the United States via live
ruminants and ruminant products and byproducts, and added Canada to
this category. We also established conditions for the importation of
certain live ruminants and ruminant products and byproducts from such
regions. These regulations are in 9 CFR parts 93, 94, 95, and 96.
On November 28, 2005, we published in the Federal Register an
interim rule (70 FR 71213-71218, Docket No. 03-080-8) that (1)
broadened who is authorized to break the seals on a means of conveyance
carrying certain ruminants from Canada and (2) amended the regulations
regarding the transiting through the United States of certain ruminant
products from Canada to allow for limited direct transloading of the
products from one means of conveyance to another in the United States.
On March 14, 2006, we published in the Federal Register a technical
amendment (71 FR 12994-12998, Docket No. 03-080-9) that clarified our
intent with regard to certain provisions in the January 2005 final rule
and corrected several inconsistencies within the rule.
In this proposed rule, we are proposing to further amend the BSE
regulations to remove several restrictions related to the provisions of
the January 2005 final rule that we believe are unnecessary to prevent
the introduction of BSE from minimal-risk regions into the United
States. We discuss those proposed changes below.
Means of Identification of Bovines, Sheep, and Goats Imported From BSE
Minimal-Risk Regions
In our March 2006 technical amendment, we clarified that it was the
intent of our January 2005 final rule that all live bovines, sheep, and
goats imported from a BSE minimal-risk region be accompanied by a
health certificate in accordance with Sec. 93.405 and be individually
identified in the region of export before being shipped to the United
States. Because Canada was the only country categorized as a BSE
minimal-risk region in our final rule, and because the standard means
of individual livestock identification in Canada is an eartag, we
specified in Sec. 93.436 of the final rule that live bovines imported
from a BSE minimal-risk region--in this case, Canada--must be
individually identified by means of an official eartag of the country
of origin. The eartag must be determined by the Administrator to meet
standards equivalent to those for official eartags in the United
States, as defined in 9 CFR part 71, and to be traceable to the
[[Page 45440]]
premises of origin of the animal. We included a similar requirement in
Sec. 93.419(d)(2) for sheep and goats, but because, even before our
January 2005 final rule, Sec. 93.419 referred only to sheep and goats
from Canada, we specified that the sheep and goats must be individually
identified by an official Canadian Food Inspection Agency eartag.
We recognize that there are effective means of individual
identification other than eartags. However, as stated above, we
provided in our January 2005 final rule that the means of individual
identification must be an eartag because eartags are the required means
of identification under Canada's national livestock identification
program and Canada was the only country we were categorizing as a BSE
minimal-risk region in the final rule. We now consider it advisable to
amend the regulations in a way that allows for means of individual
identification other than eartags. This change would make it clear to
any other regions requesting BSE minimal-risk status what we consider
acceptable with regard to individual identification and would give
exporters the option of individually identifying bovines, sheep, and
goats being exported to the United States by means other than eartags.
Therefore, instead of requiring in Sec. 93.436 that live bovines
imported into the United States from a BSE minimal-risk region must be
individually identified by means of an official eartag of the country
of origin, and instead of requiring in Sec. 93.419 that sheep and
goats imported into the United States from Canada must be individually
identified by an official Canadian Food Inspection Agency eartag, we
are proposing to provide instead in Sec. Sec. 93.419(c) and
93.436(a)(3) and (b)(4) that the animals must be officially identified
with individual identification before the animals' arrival at the port
of entry into the United States. We are also proposing to amend Sec.
93.405(a)(4), which currently requires that the health certificate
accompanying cattle, sheep, or goats imported from a BSE minimal-risk
region record the eartag required under Sec. 93.419 or Sec. 93.436.
We are proposing to require instead that the health certificate record
the required official identification.
We are proposing to define officially identified in Sec. 93.400 of
the regulations to mean ``individually identified by means of an
official identification device or method.'' In Sec. 93.400, official
identification device or method is currently defined as a means of
officially identifying an animal or group of animals using devices or
methods approved by the Administrator, including, but not limited to,
official tags, tattoos, and registered brands when accompanied by a
certificate of inspection from a recognized brand inspection authority.
We are not proposing to change that wording. However, we are
proposing to add a sentence at the end of the definition to make it
clear that, for animals intended for importation into the United
States, the particular device or method of identification must have
been approved by the Administrator for that type of import before the
animal is exported to the United States.
We are proposing to add that wording in order to clarify that,
although a particular kind of identification may have been approved by
the Administrator for use in particular situations or for particular
types of animals, that doesn't necessarily mean it can be used for all
types of animals and in all situations. For instance, due to an
animal's anatomy, it might not be possible to affix certain types of
tags to the animal in a way that ensures the tags will not fall off. As
another example, although the current definition of official
identification device or method includes ``registered brands'' as an
example of such identification, a brand in itself might not provide
adequate identification with regard to BSE. Although a registered brand
would enable traceback of an animal to its herd of origin, in the case
of BSE form of identification that provides more detailed information
about an individual cow, such as an eartag, would be necessary.
In the event that an importer or importing country seeks and is
granted approval to use a device or method of identification other than
one specifically provided for in the regulations, the record of that
approval and the requirements, if any, for that device or method will
be included in the protocol for imports from the exporting region,
which will be made available on the APHIS Web site at https://
www.aphis.usda.gov/vs/ncie.
Hide-Derived Gelatin
The regulations at Sec. 94.18(c) address the importation of
gelatin derived from ruminants from regions listed in Sec. 94.18(a) as
regions in which BSE exists (Sec. 94.18(a)(1)), regions that present
an undue risk of introducing BSE into the United States (Sec.
94.18(a)(2)), and BSE minimal-risk regions (Sec. 94.18(a)(3)).
With certain specified exceptions, Sec. 94.18(c) prohibits the
importation of gelatin derived from ruminants that have been in any
region listed in Sec. 94.18(a). One of the exceptions is for gelatin
derived from the bones of bovines subject to a ruminant feed ban
equivalent to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000 and from which specified risk
materials (SRMs) and small intestine were removed. We set forth the
conditions for that exception in Sec. 94.19(f) of the January 2005
final rule.
As currently written, the exception in Sec. 94.19(f) applies
exclusively to gelatin derived from the bones of bovines and not to
gelatin derived from bovine hides, even the hides of the same bovines
whose bones are used for gelatin that is allowed importation into the
United States. However, we believe there is no scientific reason to
prohibit the importation of gelatin derived from the hides of bovines.
Bovine hides have not demonstrated BSE infectivity, even in infected
animals. The safety of bovine hides with regard to BSE is recognized
internationally. The World Organization for Animal Health (commonly
referred to as the OIE) recommends in Article 2.3.13.1 of the OIE
Terrestrial Animal Health Code, 2005, that gelatin derived exclusively
from the hides of bovines not be subject to import restrictions. The
European Commission Scientific Steering Committee's Updated Opinion on
the Safety with Regard to TSE Risk of Gelatine Derived from Ruminant
Bones or Hides (adopted by the Scientific Steering Committee at its
December 5-6, 2002, meeting) states in section B(c) of that document:
``When ruminant hides are used for the production of gelatine,
they are usually obtained from bovines. On the basis of current
knowledge, it can be considered that the parts of the bovine hides
used for the production of gelatine do not present a risk with
regard to TSE's [transmissible spongiform encephalopathies, which
include BSE], provided contamination with potentially infected
materials is avoided.''
Although APHIS considers gelatin derived from bovine hides a
commodity that does not present a risk of transmitting the BSE agent,
by oversight we did not include in our January 2005 final rule such
gelatin as an exception to the general prohibition on the importation
of gelatin derived from ruminants from BSE minimal-risk regions.
Because there appears to be no scientific reason to prohibit the
importation of such gelatin from BSE minimal-risk regions, we are
proposing to amend Sec. 94.19(f) to add that gelatin derived from the
hides of bovines that have been in any region listed in Sec.
94.18(a)(3) may be imported into the United States. In order to help
ensure that such gelatin is not contaminated with the BSE agent, we are
also proposing as a condition for such
[[Page 45441]]
importation that the gelatin was not commingled with materials
ineligible for entry into the United States. We would also apply the
non-commingling requirement to gelatin derived from bones from bovines
from BSE minimal-risk regions. Such gelatin is already allowed
importation, with specified conditions, under Sec. 94.19(f).
Nonruminant Material
The regulations in Sec. 95.4 prohibit the importation of certain
materials derived from nonruminants, as well as materials derived from
ruminants. Specifically, the following nonruminant materials may not be
imported into the United States from regions listed in Sec. 94.18(a)--
or be derived from nonruminant animals that have been in a region
listed in Sec. 94.18(a)--unless certain conditions are met:
Processed animal protein, tankage, and offal;
Tallow other than tallow derivatives, unless, in the
opinion of the Administrator, the tallow cannot be used in feed; and
Processed fats and oils, and derivatives of processed
animal protein, tankage, and offal.
Among the conditions for the importation of these nonruminant
materials is that all steps of processing and storing the material must
have been carried out in a foreign facility that has not been used for
the processing and storage of materials from ruminants that have been
in any region listed in Sec. 94.18(a). The purpose of this requirement
is to eliminate the possibility that the nonruminant material could
become commingled with or contaminated by ruminant material containing
the BSE agent and therefore itself become contaminated with the BSE
agent.
We continue to consider this restriction necessary with regard to
nonruminant materials that are processed in regions listed in Sec.
94.18(a)(1) or (2) (regions in which BSE exists and regions that
present an undue risk of introducing BSE into the United States).
However, requiring that nonruminant materials be processed in separate
facilities from ruminant materials in BSE minimal-risk regions is
inconsistent with other provisions in our January 2005 final rule.
Therefore, we are proposing to eliminate that inconsistency, for the
reasons explained below.
Our January 2005 final rule allowed the importation of certain
ruminant meat, products, and byproducts from Canada (at this time
Canada is the only region recognized by APHIS as a BSE minimal-risk
region). APHIS determined that such commodities present a low risk of
introducing BSE into the United States, based on a number of factors.
These factors include the measures Canada has in place to detect and
prevent BSE within Canadian cattle and the commodity-specific
mitigation measures in the final rule. For meat (including whole or
half carcasses), meat byproducts, and meat food products derived from
bovines, the regulations require that the bovines be subject to a
ruminant feed ban, prohibit the use of an air-injected stunning process
at slaughter, and require that SRMs and the small intestine of the
bovines be removed at slaughter. Research has shown that BSE
infectivity in infected bovines is localized in specific tissues, and
removal of SRMs is an effective risk mitigation measure for bovines.
Therefore, the regulations do not require that bovine meat eligible for
entry into the United States from a BSE minimal-risk region be
processed in a facility that processes only bovine commodities eligible
for entry into the United States.\1\
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\1\ Pursuant to an announcement by the Secretary of Agriculture
on February 9, 2005, APHIS published in the Federal Register on
March 11, 2005, a document (70 FR 12112-12113, Docket No. 03-080-6)
delaying until further notice the applicability of the provisions of
the final rule as they apply to the importation from Canada of
certain commodities derived from bovines 30 months of age or older.
While the delay in applicability is in effect, commodities from
Canada derived from bovines less than 30 months of age when
slaughtered will be required to be processed in an establishment
that operates in compliance with an approved Canadian Food
Inspection Agency program to prevent commingling of ruminant
products eligible for export to the United States with ruminant
products ineligible for export to the United States. This is to
ensure that only products from bovines less than 30 months of age
are exported to the United States, however; not to prevent
contamination.
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In sheep and goats, research has not identified SRMs that could be
removed to eliminate any potential infectivity from infected animals.
Infectivity has not been demonstrated in most tissues in sheep and
goats until at least 16-months post-exposure to the BSE agent.
Therefore, for meat (including whole or half carcasses), meat
byproducts, and meat food products from sheep or goats or other ovines
or caprines, the regulations require that the animals, among other
things, be less than 12 months of age when slaughtered and be
slaughtered at a facility that either slaughters only sheep and/or
goats or other ovines and caprines less than 12 months of age or
complies with a segregation process approved by the national veterinary
authority of the region of origin and the Administrator as adequate to
prevent contamination or commingling of the meat with products not
eligible for importation into the United States.
In both cases, however--for products derived from bovines and for
products derived from sheep or goats--the regulations do not require
that the animals necessarily be slaughtered in a facility dedicated
only to ruminant products eligible for entry into the United States.
Because products derived from nonruminants pose even less of a BSE risk
than those derived from ruminants, it is inconsistent with the January
2005 final rule to require in Sec. 95.4 that, in a region listed in
Sec. 94.18(a)(3) (i.e., a BSE minimal-risk region), all steps of
processing nonruminant protein, tankage, offal, and tallow other than
tallow derivatives, as well as processed fats and oils, and derivatives
of processed animal protein, tankage, and offal derived from
nonruminants, be carried out in a facility that has not been used for
the processing and storage of materials from ruminants that have been
in any region listed in Sec. 94.18(a)(3) (a BSE minimal-risk region).
Therefore, we are proposing to amend Sec. 95.4 by adding a new
paragraph (c)(3) to require that, for facilities in regions listed in
Sec. 94.18(a)(3), steps of processing and storing the nonruminant
material are carried out in a 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)(1) or (a)(2).
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The rule
has been determined to be not significant for the purposes of Executive
Order 12866 and, therefore, has not been reviewed by the Office of
Management and Budget.
The Regulatory Flexibility Act requires agencies to evaluate the
potential effects of their proposed and final rules on small
businesses, small organizations, and small governmental jurisdictions.
We have prepared an initial regulatory flexibility analysis, which is
set forth below.
In a final rule published in January 2005, we established a
category of regions that present a minimal risk of introducing BSE into
the United States via live ruminants and ruminant products and
byproducts, and added Canada to this category. We also established
conditions for the importation of certain live ruminants and ruminant
products and byproducts from such regions.
In this proposed rule, we are proposing to remove certain
restrictions on imports from BSE minimal-risk
[[Page 45442]]
regions that concern animal identification, the derivation of bovine
gelatin, and the processing of ruminant and nonruminant materials. We
do not believe these restrictions are necessary to prevent the
introduction of BSE into the United States.
Instead of limiting the type of allowable individual identification
on bovines, sheep, and goats imported from a BSE minimal-risk region to
an official eartag of the country of origin, we are proposing to allow
individual identification of animals by means other than eartags,
provided the APHIS Administrator has approved the manner of
identification for the type of animal intended for importation.
Instead of limiting the importation of bovine-derived gelatin from
BSE minimal-risk regions to gelatin derived from bones, we are
proposing to also allow the importation of hide-derived gelatin,
provided certain conditions are met.
We are also proposing to allow nonruminant material that is
processed in BSE minimal-risk regions--such as processed animal
protein, tankage, offal, certain tallow, processed fats and oils, and
derivatives of processed animal protein, tankage, and offal--to be
processed in facilities that also process material derived from
ruminants from the minimal-risk region.
We address below the potential economic effect of each of these
changes.
Animal Identification
Giving owners of bovines, sheep, and goats in BSE minimal-risk
regions the option of individually identifying animals being exported
to the United States by means other than eartags is not expected to
affect U.S. small entities. This amendment simply acknowledges that
there are effective means of individual identification other than
eartags. However, APHIS welcomes information that the public may offer
on ways this amendment may impact small entities, and the type and
number of small entities that would be affected.
Hide-Derived Gelatin
This amendment, by allowing the importation of gelatin derived from
bovine hides, in addition to gelatin derived from bovine bones, could
affect U.S. entities by providing for an additional source of gelatin
imported from Canada.
Gelatin is derived from collagen, an insoluble fibrous protein that
is the principal constituent of connective tissues and bones. The main
raw materials used in gelatin production are cattle bones, cattle
hides, and porkskins. Gelatin recovered from bone is used primarily in
photographic applications. Porkskin is currently the most significant
raw material source for production of edible gelatin in North America.
Cattle hides are the least used raw material for gelatin in North
America today. Cattle hides sourced by member companies of the Gelatin
Manufacturers Institute of America for the production of gelatin for
food use are purchased from a small number of tanneries in the United
States.
We do not have information about the quantity of hide-derived
gelatin that would be imported from Canada because of this proposed
rule, nor do we have an estimate of the number of U.S. small entities
that would be affected. Production of animal hides is classified by the
North American Industry Classification System (NAICS) under ``Animal
(except Poultry) Slaughtering'' (NAICS 311611), for which the small
entity definition is businesses with not more than 500 employees. We
welcome information that would allow us to better understand the number
and size of entities that could be affected by allowing the importation
of hide-derived bovine gelatin from Canada, and the extent of the
possible impact.
Nonruminant Material
This amendment would remove the requirement that nonruminant
material that is processed in BSE minimal-risk regions be processed in
a facility that does not also process material derived from ruminants
from the minimal-risk region. If this amendment were to result in
changes in the amounts of nonruminant material imported by the United
States, then U.S. entities could be affected. Affected nonruminant
material may include processed animal protein, tankage, offal, certain
tallow, processed fats and oils, and derivatives of processed animal
protein, tankage, and offal.
Facilities that produce these commodities are classified under
``Rendering and Meat By-product Processing'' (NAICS 311613), for which
the small entity definition is businesses with not more than 500
employees. We do not have a basis for estimating the change in imports
of Canadian nonruminant materials that may result from the proposed
rule, nor do we know the number or size of U.S. entities that would be
affected. APHIS welcomes information that the public may provide
regarding the number of small entities that could be affected and the
likely magnitude of the effect.
APHIS has not identified any Federal rules that may duplicate,
overlap, or conflict with this proposed rule, and believes there are no
significant alternatives to this proposed rule that would accomplish
the stated objectives.
Executive Order 12988
This proposed rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this proposed rule is adopted: (1) All State
and local laws and regulations that are inconsistent with this rule
will be preempted; (2) no retroactive effect will be given to this
rule; and (3) administrative proceedings will not be required before
parties may file suit in court challenging this rule.
Paperwork Reduction Act
This proposed rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
List of Subjects
9 CFR Part 93
Animal diseases, Imports, Livestock, Poultry and poultry products,
Quarantine, Reporting and recordkeeping requirements.
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 95
Animal feeds, Hay, Imports, Livestock, Reporting and recordkeeping
requirements, Straw, Transportation. Accordingly, we are proposing to
amend 9 CFR parts 93, 94, and 95 as follows:
PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, AND POULTRY, AND
CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR MEANS
OF CONVEYANCE AND SHIPPING CONTAINERS
1. The authority citation for part 93 would continue to read as
follows:
Authority: 7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a;
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
2. Section 93.400 would be amended by revising the definition of
official identification device or method and adding a definition of
officially identified, in alphabetical order, to read as follows:
Sec. 93.400 Definitions.
* * * * *
Official identification device or method. A means of officially
identifying an animal or group of animals using devices or methods
[[Page 45443]]
approved by the Administrator, including, but not limited to, official
tags, tattoos, and registered brands when accompanied by a certificate
of inspection from a recognized brand inspection authority. For animals
intended for importation into the United States, the device or method
of identification used must have been approved by the Administrator for
that type of import before the animal is exported to the United States.
* * * * *
Officially identified. Individually identified by means of an
official identification device or method.
* * * * *
3. In Sec. 93.405, paragraph (a)(4) would be amended by removing
the word ``eartag'' and adding in its place the words ``official
identification.''
4. Section 93.419 would be amended by revising paragraph (c),
introductory text, and paragraphs (d)(2), (d)(5), (d)(7)(i), and
(d)(7)(iii) to read as follows:
Sec. 93.419 Sheep and goats from Canada.
* * * * *
(c) Any sheep or goats imported from Canada must not be pregnant,
must be less than 12 months of age when imported into the United States
and when slaughtered, must be 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, and must be
officially identified with individual identification before the
animal's arrival at the port of entry into the United States. No person
may alter, deface, remove, or otherwise tamper with the official
identification while the animal is in the United States or moving into
or through the United States, except that the identification may be
removed at the time of slaughter. The animals must be accompanied by
the certification issued in accordance with Sec. 93.405 that states,
in addition to the statements required by Sec. 93.405, that the
conditions of this paragraph have been met. Additionally, for sheep and
goats imported for other than immediate slaughter, the certificate must
state that the conditions of paragraph (d)(1) of this section have been
met. For sheep and goats imported for immediate slaughter, the
certificate must also state that:
* * * * *
(d) * * *
(2) The animals may be moved from the port of entry only to a
feedlot designated in accordance with paragraph (d)(7) of this section
and must be accompanied from the port of entry to the designated
feedlot by APHIS Form VS 17-130 or other movement documentation deemed
acceptable by the Administrator, which must identify the physical
location of the feedlot, the individual responsible for the movement of
the animals, and the individual identification of each animal, which
includes the official identification required under paragraph (c) of
this section and any other identification present on the animal,
including registration number, if any:
* * * * *
(5) The animals must be accompanied to the recognized slaughtering
establishment by APHIS Form VS 1-27 or other documentation deemed
acceptable by the Administrator, which must identify the physical
location of the recognized slaughtering establishment, the individual
responsible for the movement of the animals, and the individual
identification of each animal, which includes the official
identification required under paragraph (c) of this section and any
other identification present on the animal, including registration
number, if any;
* * * * *
(7) * * *
(i) Will not remove official identification from animals unless
medically necessary, in which case new official identification will be
applied and cross referenced in the records;
* * * * *
(iii) Will maintain records of the acquisition and disposition of
all imported sheep and goats entering the feed lot, including the
official identification number and all other identifying information,
the age of each animal, the date each animal was acquired and the date
each animal was shipped to slaughter, and the name and location of the
plant where each animal was slaughtered. For Canadian animals that die
in the feedlot, the feedlot will remove the official identification
device if affixed to the animal, or will record any other official
identification on the animal and place the official identification
device or record of official identification in a file with a record of
the disposition of the carcass;
* * * * *
5. Section 93.436 would be amended as follows:
a. Paragraphs (a)(3) and (b)(4) would be revised to read as set
forth below.
b. In paragraphs (b)(8) and (b)(11), the word ``eartag'' would be
removed and the words ``official identification'' would be added in its
place.
Sec. 93.436 Ruminants from regions of minimal risk for BSE.
* * * * *
(a) * * *
(3) Each bovine must be officially identified with individual
identification before the animal's arrival at the port of entry into
the United States. No person may alter, deface, remove, or otherwise
tamper with the official identification while the animal is in the
United States or moving into or through the United States, except that
the identification may be removed at slaughter;
* * * * *
(b) * * *
(4) Each bovine must be officially identified with individual
identification before the animal's arrival at the port of entry into
the United States. No person may alter, deface, remove, or otherwise
tamper with the official identification while the animal is in the
United States or moving into or through the United States, except that
the identification may be removed at slaughter;
* * * * *
PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND
RESTRICTED IMPORTATIONS
6. The authority citation for part 94 would continue to read as
follows:
Authority: 7 U.S.C. 450, 7701-7772, 7781-7786, and 8301-8317; 21
U.S.C. 136 and 136a; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.
7. In Sec. 94.19, paragraph (f) would be revised to read as
follows:
Sec. 94.19 Restrictions on importation from BSE minimal-risk regions
of meat and edible products from ruminants.
* * * * *
(f) Gelatin other than that allowed importation under Sec.
94.18(c). The gelatin is derived from:
(1) The bones of bovines subject to a ruminant feed ban equivalent
to the requirements established by the U.S. Food and Drug
Administration at 21 CFR 589.2000 and from which SRMs and small
intestine were removed, and the gelatin has not been commingled with
materials ineligible for entry into the United States; or
(2) The hides of bovines, and the gelatin has not been commingled
with materials ineligible for entry into the United States.
* * * * *
[[Page 45444]]
PART 95--SANITARY CONTROL OF ANIMAL BYPRODUCTS (EXCEPT CASINGS),
AND HAY AND STRAW, OFFERED FOR ENTRY INTO THE UNITED STATES
8. The authority citation for part 95 would continue to read as
follows:
Authority: 7 U.S.C. 8301-8317; 21 U.S.C. 136 and 136a; 31 U.S.C.
9701; 7 CFR 2.22, 2.80, and 371.4.
9. Section 95.4 would be amended as follows:
a. Paragraph (c)(2) would be revised to read as set forth below.
b. Paragraphs (c)(3) through (c)(7) would be redesignated as
paragraphs (c)(4) through (c)(8), respectively.
c. A new paragraph (c)(3) would be added to read as set forth
below.
d. Newly designated paragraph (c)(7) would be revised to read as
set forth below.
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.
(c) * * *
(2) Except for material processed or stored in regions listed in
Sec. 94.18(a)(3) of this subchapter, all steps of processing and
storing the material are carried out in a 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
subchapter.
(3) For material processed or stored in regions listed in Sec.
94.18(a)(3) of this subchapter, all steps of processing and storing the
material are carried out in a 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)(1) or (a)(2) of this
subchapter.
* * * * *
(7) 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 conditions of paragraphs (c)(1) through
(c)(4) 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.
* * * * *
Done in Washington, DC, this 3rd day of August 2006.
Elizabeth E. Gaston,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-12944 Filed 8-8-06; 8:45 am]
BILLING CODE 3410-34-P