[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