Importation of Pork and Pork Products

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