[Federal Register Volume 65, Number 6 (Monday, January 10, 2000)]
[Rules and Regulations]
[Pages 1304-1308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-436]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 94 and 96
[Docket No. 95-027-2]
Importation of Pork and Pork Products
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are amending the regulations concerning the importation of
pork and pork products into the United States. Specifically, we will
allow pork that originates in a region where African swine fever exists
to be imported into the United States if it has been heated to an
internal temperature of at least 69 deg.C after the bones have been
removed. We also will provide an alternative, dry heat processing
method for pork from regions where swine vesicular disease exists. In
addition, we are making other minor amendments to the regulations for
importing pork and pork products from regions where African swine
fever, swine vesicular disease, or hog cholera exists. These changes
will relieve some restrictions on the importation of pork and pork
products from regions where these diseases exist without presenting a
significant risk of introducing African swine fever, hog cholera, or
swine vesicular disease into the United States.
EFFECTIVE DATE: February 9, 2000.
FOR FURTHER INFORMATION CONTACT: Dr. Masoud A. Malik, Senior Staff
Veterinarian, Import/Export Products, National Center for Import and
Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231;
(301) 734-7834.
SUPPLEMENTARY INFORMATION:
Background
The regulations in 9 CFR part 94 (the regulations) prohibit or
restrict the importation of specified animals and animal products into
the United States to prevent the introduction of various animal
diseases, including foot-and-mouth disease, rinderpest, African
[[Page 1305]]
swine fever (ASF), hog cholera (HC), and swine vesicular disease (SVD),
into the United States. These are dangerous and destructive
communicable diseases of ruminants and swine. Section 94.8 of the
regulations restricts the importation of pork and pork products into
the United States from regions in which ASF exists or is reasonably
believed to exist (ASF regions). Section 94.9 of the regulations
restricts the importation into the United States of pork and pork
products from regions where HC is known to exist (HC regions). Section
94.12 of the regulations restricts the importation into the United
States of pork and pork products from regions where SVD is known to
exist (SVD regions). According to the regulations, pork and pork
products from an ASF, HC, or SVD region must be processed as specified
in the regulations to be eligible for entry into the United States.
One of the options for processing pork and pork products in an ASF
region is that the bones must be removed and then the pork or pork
product must be heated, by a method other than flash heating, to an
internal temperature of at least 69 deg.C. (156 deg.F.) throughout.
To qualify for this option, the pork or pork products must have
originated from swine raised and slaughtered in a region free of ASF.
In addition, the pork must be shipped to the processing facility in the
ASF region in a sealed container and accompanied by a certificate of
origin, and the processing establishment may not receive any live swine
and may use only pork or pork products that originate in an ASF-free
region. The processing establishments must also enter into a compliance
agreement and trust fund agreement with the Animal and Plant Health
Inspection Service (APHIS) that provides for, and pays the costs of,
APHIS inspections of the facilities to ensure compliance with the
regulations.
The regulations in 9 CFR part 96 govern the importation of swine
casings into the United States to prevent the introduction of
contagious livestock diseases. Swine casings are intestines, stomachs,
esophagi, and urinary bladders from swine that are used to encase
processed meats, such as sausage. The ASF virus may be present in, and
spread by, swine, pork, pork products, and byproducts, including
casings. Section 96.2(a) specifically prohibits the importation of
swine casings that originated in an ASF region.
On July 14, 1999, we published in the Federal Register (64 FR
37897-37903, Docket No. 95-027-1) a proposed rule to, among other
things, amend the requirements in Sec. 94.8 concerning pork and pork
products from regions listed as having ASF. We proposed to remove the
requirements that the pork or pork products originate in an ASF-free
region because research has shown that removing the bones and heating
the pork or pork products to an internal temperature of at least 69
deg.C. (156 deg.F.) throughout is sufficient to destroy the virus that
causes ASF. In conjunction with this change, we also proposed to remove
the requirements that the pork be shipped to the processing facility in
a sealed container and accompanied by a certificate of origin. We also
proposed to remove the requirements that the processing establishment
may not receive any live swine and may use only pork or pork products
that originate in an ASF-free region. We proposed to require, instead,
that the facility take specified steps to ensure that pork or pork
products intended for export to the United States are not commingled
with other pork or pork products or contaminated after processing.
Additionally, we proposed to remove the requirements for a compliance
agreement, trust fund agreement, and the attendant inspections, and to
rely, instead, on certification by the national government of the
region in which the processing facility is located.
We proposed editorial changes to the regulations in 9 CFR part 96,
which contains references to Sec. 94.8.
We also proposed several changes to the processing requirements for
pork and pork products from HC and SVD regions.
We solicited comments concerning our proposal for 60 days ending
September 13, 1999. We received five comments by that date. The
comments were from an association representing domestic pork producers
and from foreign meat processors and their representatives. Four of the
comments supported the proposal as written. One comment, while
supportive of the changes in processing requirements related to ASF,
emphasized that adequate safeguards must be in place to ensure that
processing is properly performed and that contamination during and
after processing does not occur. This comment is discussed in more
detail below.
Comment: The current requirements for operators of processing
establishments in ASF regions to enter into a compliance agreement and
trust fund agreement with APHIS should be retained. APHIS must continue
to inspect the establishments to ensure that they meet U.S.
requirements. Certification by the foreign government that the pork and
pork products have been processed in accordance with the regulations
should be a requirement in addition to, not instead of, these
agreements and inspections.
Response: We believe that it is safe and appropriate to shift
responsibility of ensuring compliance with our regulations to the
national government of the region where the pork is processed.
Establishments processing pork and pork products under this final rule
must continue to meet requirements under the Federal Meat Inspection
Act (21 U.S.C. 601 et seq.) and regulations in 9 CFR, chapter III, part
327. The Food Safety and Inspection Service of the U.S. Department of
Agriculture periodically inspects these processing establishments to
make sure important requirements, including cooking temperature
requirements, are met. If there is indication that any of our
requirements are not being met by a particular establishment, we can
turn back shipments that don't meet our requirements and enforce a hold
order for increased sampling of future shipments of pork and pork
products coming from that establishment until we are certain that all
of our requirements are being met. The type of certification we will
require for pork and pork products from ASF regions is already required
for pork and pork products from HC and SVD regions and has proven
effective in guarding against the introduction of those diseases into
the United States. Therefore, we are not making any change to the rule
based on this comment.
Comment: APHIS should provide detailed guidance to processing
plants on specific procedures, including types of disinfectants, to use
in the processing establishments. Also, more definition should be
provided on what is meant by processing U.S. eligible pork and pork
products at the same time as ineligible pork and pork products. Does
this refer to the entire operation from slaughter through fabrication,
or only the fabrication area? For proper disinfection and clearing of
ineligible pork and pork products, this should refer to the entire
plant.
Response: There are various standard procedures and disinfectants
that are used by processing establishments for cleaning and
disinfecting that are effective in ensuring that pork and pork products
processed for exportation will not become contaminated with the ASF
virus. We believe that the operators of processing facilities should be
allowed to choose an effective method for cleaning and disinfection as
permitted by the government of their country. Each area, utensil, and
piece of equipment that comes in contact with pork or pork products
that are not
[[Page 1306]]
eligible for export to the United States must be disinfected before it
can be used for processing or other handling of pork or pork products
that are eligible for export to the United States. Thus, processing
establishments will need to make separate processing runs for pork or
pork products that are eligible for export to the United States and
pork or pork products that are not, thereby eliminating any possibility
of commingling the two from the time they enter the establishments
until the time they are packaged.
Original Certificates
Under Secs. 94.8 and 96.2 of this rule, we require that pork and
pork products from ASF regions and swine casings processed in ASF
regions, respectively, must be accompanied by a certificate stating
that all of the requirements in the regulations have been met. Our
intention was that the original certificate that is issued by the
official of the national government in the region in which the
processing establishment is located would accompany the shipment and
then be presented to an authorized inspector at the port of arrival. In
most cases, the certificate that is presented to an authorized
inspector is the original certificate; however, occasionally, a copy of
the certificate is presented. To clarify that we require an original
certificate, we are amending Secs. 94.8(a)(3)(iii) and 96.2(a)(9) in
this final rule to specify that the shipment must be accompanied by an
original certificate.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, with the
changes discussed in this document.
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.
This rule amends 9 CFR 94.8 to allow pork and pork products that
originated in an ASF region to be imported into the United States if
the meat has been cooked to a minimum internal temperature of 69
deg.C. (156 deg.F.) throughout after removal of the bones.
Regions listed in Sec. 94.8 as regions in which ASF exists or is
reasonably believed to exist are all the countries of Africa; Brazil,
Cuba, Haiti, and Malta; and the Island of Sardinia, Italy.
Total pork production in the United States in 1996 was 7,764,000
metric tons. Brazil, the largest pork producer of the listed regions,
produced 1,600,000 metric tons of pork in 1996. The combined pork
production of the other listed regions was 1,033,767 metric tons in
1996. While Brazil's pork production was 21 percent of the U.S. pork
production in 1996, the second largest pork producer among the other
listed regions was Nigeria. Nigeria produced 278,080 metric tons of
pork, only 4 percent of U.S. pork production. Therefore, other than
Brazil, none of the listed regions produces enough pork to make the
possibility of increased exports from those countries likely.
Furthermore, much of the pork produced in Brazil and the other listed
regions is consumed in the region of origin. This trend is expected to
continue based on the strong pork demand in Brazil and the other listed
regions. In 1996, Brazil consumed 97 percent of its pork production,
exporting only 56,000 metric tons. According to projections by the
Economic Research Service (ERS) of the United States Department of
Agriculture, Brazil is expected to consume 94 percent of its increasing
pork production in each of the years 2000 through 2005. Even if Brazil
exported to the United States the remaining 6 percent of its pork
production in those years, those exports would only represent about 1
percent of projected U.S. pork production. Therefore, adoption of this
rule is unlikely to significantly affect the pork industry or consumer
prices in the United States.
Additionally, ERS projected that U.S. pork imports would decline by
more than 1 percent annually between 1998 and 2007. Declining imports
are expected due to the restructured U.S. pork industry. One of the
results of the restructuring has been production of low-cost pork
products. These low-cost pork products are expected, increasingly, to
price imported pork out of the domestic U.S. market.
This rule will allow pork from SVD regions to be processed using
dry heat after deboning. This dry heat cooking method can produce
Mortadella ham and other meats. Italian producers of Mortadella ham are
interested in exporting Mortadella ham to the United States.
The precise volume of Mortadella ham that would enter the United
States as a result of this rule is not available. However, we expect
the volume will be minimal. Mortadella ham is a specialty food that is
likely to satisfy only a small niche market in the United States. Due
to its high fat content, Mortadella ham is not likely to be popular
with a broad cross section of American consumers.
Based on this information, we expect very little additional pork or
pork products to be imported into the United States as a result of this
rule. Thus, any economic effect on small domestic swine producers will
likely be minimal. In 1997, there were about 109,754 hog and pig farms
in the United States, of which an estimated 91 percent would be
considered ``small'' entities (annual sales of less than $0.5 million,
according to the Small Business Administration (SBA) size criteria).
These small entities maintain about 40 percent of the U.S. hog and pig
inventories.
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 final 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 no
retroactive effect; and (3) Does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final rule contains no new information collection or
recordkeeping requirements under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
Regulatory Reform
This action is part of the President's Regulatory Reform
Initiative, which, among other things, directs agencies to remove
obsolete and unnecessary regulations and to find less burdensome ways
to achieve regulatory goals.
Lists of Subjects
9 CFR Part 94
Animal diseases, Imports, Livestock, Meat and meat products, Milk,
Poultry and poultry products, Reporting and recordkeeping requirements.
9 CFR Part 96
Imports, Livestock, Reporting and recordkeeping requirements.
Accordingly, we are amending 9 CFR parts 94 and 96 as follows:
[[Page 1307]]
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. 147a, 150ee, 161, 162, and 450; 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
371.2(d).
2. Section 94.8 is amended as follows:
a. In the introductory paragraph by removing the word ``island''
and adding the word ``Island'' in its place.
b. By revising paragraph (a)(3) to read as set forth below.
c. By adding a new paragraph (a)(4) to read as set forth below.
d. By removing paragraph (d).
Sec. 94.8 Pork and pork products from regions where African swine
fever exists or is reasonably believed to exist.
* * * * *
(a) * * *
(3) Such pork or pork product:
(i) Was processed in a single establishment that meets the
requirements in paragraph (a)(4).
(ii) Was heated by other than a flash-heating method to an internal
temperature of at least 69 deg.C. (156 deg.F.) throughout after the
bones had been removed.
(iii) Is accompanied to the United States by an original
certificate stating that all of the requirements of this section have
been met. The certificate must be written in English. The certificate
must be issued by an official of the national government of the region
in which the processing establishment is located. The official must be
authorized to issue the foreign meat inspection certificate required by
part 327 of chapter III of this title. Upon arrival of the pork or pork
products in the United States, the certificate must be presented to an
authorized inspector at the port of arrival.
(4) The processing establishment \9\ in a region listed in this
section must comply with the following requirements:
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\9\ As a condition of entry into the United States, pork or pork
products must also meet all of the requirements of the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.) and regulations thereunder (9
CFR, chapter III, part 327), including requirements that the pork or
pork products be prepared only in approved establishments.
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(i) All areas, utensils, and equipment likely to contact the pork
or pork products to be processed, including skinning, deboning,
cutting, and packing areas, and related utensils and equipment, must be
cleaned and disinfected after processing pork or pork products not
eligible for export to the United States and before processing any pork
or pork products eligible for export to the United States.
(ii) Pork or pork products eligible for export to the United States
may not be handled, cut, or otherwise processed at the same time as any
pork or pork products not eligible for export to the United States.
(iii) Pork or pork products eligible for export to the United
States must be packed in clean new packaging that is clearly
distinguishable from that containing any pork or pork products not
eligible for export to the United States.
* * * * *
3. In Sec. 94.9, paragraphs (b)(1)(ii)(A) and (b)(1)(ii)(B) are
revised to read as follows:
Sec. 94.9 Pork and pork products from regions where hog cholera
exists.
* * * * *
(b) * * *
(1) * * *
(ii) * * *
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product was heated by other than a flash-
heating method to an internal temperature of 69 deg.C. (156 deg.F.)
throughout; or
* * * * *
4. Section 94.12 is amended as follows:
a. By removing ``; or'' and adding a period in its place at the end
of paragraph (b)(1)(i) and at the end of paragraph (b)(1)(iii)(B).
b. By revising paragraphs (b)(1)(ii)(A) and (b)(1)(ii)(B) to read
as set forth below.
c. By adding a new paragraph (b)(1)(v) to read as set forth below.
d. In paragraph (b)(2), by removing the word ``; and'' at the end
of the paragraph and adding a period in its place.
Sec. 94.12 Pork and pork products from regions where swine vesicular
disease exists.
* * * * *
(b) * * *
(1) * * *
(ii) * * *
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product received heat treatment in a
commercially accepted manner used for perishable canned pork products
so that it reached an internal temperature of 69 deg.C. (156 deg.F.)
throughout.
* * * * *
(v) Such pork or pork product is in compliance with the following
requirements:
(A) All bones were completely removed prior to cooking; and
(B) Such pork or pork product received continual heat treatment in
an oven for a minimum of 10 hours so that it reached an internal
temperature of 65 deg.C. (149 deg.F.) throughout. The oven
temperature started at a minimum of 62 deg.C. (143.6 deg.F.) and
reached at least 85 deg.C. (185 deg.F.).
* * * * *
PART 96--RESTRICTION OF IMPORTATIONS OF FOREIGN ANIMAL CASINGS
OFFERED FOR ENTRY INTO THE UNITED STATES
6. The authority citation for part 96 continues to read as follows:
Authority: 21 U.S.C. 111, 136, 136a; 7 CFR 2.22, 2.80, and
371.2(d).
Sec. 96.10 [Amended]
7. Section 96.10 is amended by redesignating footnote 1 and its
reference as footnote 2.
8. Section 96.2 is revised to read as follows:
Sec. 96.2 Prohibition of casings due to African swine fever and bovine
spongiform encephalopathy.
(a) Swine casings. The importation of swine casings that originated
in or were processed in a region where African swine fever exists, as
listed in Sec. 94.8 of this subchapter, is prohibited, with the
following exception: Swine casings that are processed in a region where
African swine fever exists may be imported into the United States under
the following conditions:
(1) Origin of casings. The swine casings were derived from swine
raised and slaughtered in a region not listed in Sec. 94.8(a) of this
subchapter.
(2) Shipping requirements. The casings were shipped from the region
of origin to a processing establishment in a region listed in Sec. 94.8
of this subchapter in a closed container sealed with serially numbered
seals applied by an official of the national government of the region
of origin.
(3) Origin certificate. The casings were accompanied from the
region of origin to the processing establishment by a certificate
written in English and signed by an official of the national government
of the region of origin specifying the region of origin, the processing
establishment to which the swine casings were consigned, and the
numbers of the seals applied.
[[Page 1308]]
(4) Integrity of seals. The casings were taken out of the container
at the processing establishment only after an official of the national
government of the region where the processing establishment is located
determined that the seals were intact and free of any evidence of
tampering and had so stated on the certificate referred to in paragraph
(a)(3) of this section.
(5) The processing establishment. The casings were processed at a
single processing establishment \1\ in a region listed in Sec. 94.8 of
this subchapter. The processing establishment does not receive or
process any live swine and uses only pork and pork products that
originate in a region not listed in Sec. 94.8 of this subchapter and
that are shipped to the processing establishment in accordance with
paragraphs (a)(2) through (a)(4) of this section.
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\1\ As a condition of entry into the United States, pork or pork
products must also meet all of the requirements of the Federal Meat
Inspection Act (21 U.S.C. 601 et seq.) and regulations under the Act
(9 CFR, chapter III, part 327), including requirements that the pork
or pork products be prepared only in approved establishments.
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(6) Compliance agreement. The processing establishment is operated
by persons who have entered into a valid written compliance agreement
with APHIS to maintain on file at the processing establishment for at
least 2 years copies of the certificates referred to in paragraph
(a)(4) of this section, to allow APHIS personnel to make unannounced
inspections as necessary to monitor compliance with the provisions of
this section, and to otherwise comply with the provisions of this
section.
(7) Cooperative service agreement. The processing establishment is
operated by persons who have entered into a cooperative service
agreement with APHIS. The establishment is current in paying for APHIS
personnel to inspect the establishment (it is anticipated that such
inspections will occur once per year). In addition, the processing
establishment has on deposit with APHIS an unobligated amount equal to
the cost for APHIS personnel to conduct one inspection, including
travel, salary, subsistence, administrative overhead, and other
incidental expenses (including excess baggage provisions up to 150
pounds).
(8) Compliance agreement cancellation. Any compliance agreement may
be canceled orally or in writing by the inspector who is supervising
its enforcement whenever the authorized inspector finds that such
person has failed to comply with the provisions of this section or any
conditions imposed by this section. If the cancellation is oral, the
decision and the reasons will be confirmed in writing, as promptly as
circumstances allow. Any person whose compliance agreement has been
canceled may appeal the decision to the Administrator, in writing,
within 10 days after receiving written notification of the
cancellation. The appeal should state all of the facts and reasons upon
which the person relies to show that the compliance agreement was
wrongfully canceled. The Administrator will grant or deny the appeal,
in writing, stating the reasons for such decision, as promptly as
circumstances allow. If there is a conflict as to any material fact, a
hearing will be held to resolve such conflict. Rules of Practice
governing such a hearing will be adopted by the Administrator.
(9) Export certification. The casings are accompanied to the United
States by an original certificate stating that all of the requirements
of this section have been met. The certificate must be written in
English. The certificate must be issued by an official of the national
government of the region in which the processing establishment is
located. The official must be authorized to issue the foreign meat
inspection certificate required by part 327 in chapter III of this
title. Upon arrival of the swine casings in the United States, the
certificate must be presented to an authorized inspector at the port of
arrival.
(b) Bovine or other ruminant casings. The importation of casings,
except stomachs, from bovines and other ruminants that originated in or
were processed in any region listed in Sec. 94.18(a) of this subchapter
is prohibited.
(Approved by the Office of Management and Budget under control
number 0579-0015)
Done in Washington, DC, this 23rd day of December 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-436 Filed 1-7-00; 8:45 am]
BILLING CODE 3410-34-U