Cooked Meat From Countries Where Rinderpest or Foot-and-Mouth Disease Exists

DEPARTMENT OF AGRICULTURE

9 CFR Part 94

[Docket No. 92-007-2]

Cooked Meat From Countries Where Rinderpest or Foot-and-Mouth

Disease Exists

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are revising the regulations concerning cooked meat

intended for importation into the United States from countries where

rinderpest or foot-and-mouth disease exists. The regulations require

that this meat meet a new standard for ``thoroughly cooked,'' and

specify conditions for the cooking process. Further, the regulations

establish standards for meat processing establishments in those

countries, and require that cooked meat come only from establishments

that meet these standards. This action ensures that the meat intended

for importation into the United States from a country where rinderpest

or foot-and-mouth disease exists has been cooked sufficiently to

inactivate any rinderpest or foot-and-mouth disease virus and prevent

the introduction of either disease into the United States.

EFFECTIVE DATE: April 20, 1994.

FOR FURTHER INFORMATION CONTACT: Dr. John H. Blackwell, Senior Staff

Microbiologist, Import-Export Products Staff, National Center for

Import-Export, Veterinary Services, APHIS, USDA, room 756-A, Federal

Building, 6505 Belcrest Road, Hyattsville, MD 20782, (301) 436-7834.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 94 regulate, among other things, the

importation into the United States of certain animals, meat, and animal

products. These regulations are designed to prevent the introduction

into the United States of certain diseases of livestock and poultry.

Section 94.4 (referred to below as the regulations) restricts the

importation into the United States of cured and cooked meat from

countries where rinderpest or foot-and-mouth disease (FMD) exists, in

order to prevent the introduction of those diseases into the United

States. Cured and cooked meats that meet the conditions stipulated in

the regulations are eligible for entry into the United States.

On July 16, 1993, we published in the Federal Register (58 FR

38316-38321, Docket No. 92-007-1) a proposal to amend the regulations

by requiring that cooked meat from countries where rinderpest or FMD

exists meet a new standard for ``thoroughly cooked,'' and specifying

conditions for the cooking process. Further, we proposed standards for

meat processing establishments in countries where rinderpest or FMD

exists, and proposed to require that cooked meat come only from

establishments that meet these standards.

We proposed that meats for which the pink juice is invalid be

considered thoroughly cooked when they have been cooked in a specified

way, for a specified period, at a specified temperature believed to be

capable of inactivating any rinderpest or FMD virus present. For those

meats, we proposed to require use of a temperature indicator device

(TID), a device inserted into meat before cooking, to ensure that the

meat reaches the specified temperature.

We solicited comments concerning our proposal for a 60-day comment

period ending September 14, 1993. We received 8 comments by that date.

They were from exporters, importers, representatives of professional

and industry associations, and a representative of a foreign

government. We carefully considered all of the comments we received.

While all generally supported our proposal, some suggested

modifications. Those suggestions are discussed below, by topic.

Temperature Indicator Device (Sec. 94.0)

One commenter suggested that we explicitly require that temperature

indicator devices (TID's) be calibrated or certified in accordance with

USDA standards, to verify their accuracy and reliability. We agree that

we must verify the accuracy of TID's before use, and defined the TID as

``precalibrated'' for that reason. To clarify this point, we have

revised the definition of Temperature Indicator Device to state that

the Administrator will approve a TID for use only after determining

that the chemical compound contained in the device is activated at the

specific temperature required.

Ground Meat Cooked in an Oven (Sec. 94.4(b)(4))

Two commenters objected to the specificity of the proposed

provisions for ground meat cooked in an oven, and recommended that

Sec. 94.4(b)(4) allow for variations in temperature or patty size if

such variations result in the inactivation of the rinderpest or FMD

virus. These commenters encouraged us to consider alteratives to the

``combination of precisely defined conditions'' set forth in the

proposed rule. We agree that variations in the cooking process may

prove effective in inactivating the rinderpest or FMD virus. However,

data proving the validity of that assumption are not currently

available. Should such data become available in the future, we would

propose to revise the regulations accordingly. However, there is no

basis for change as a result of the comments at this time.

Two commenters asked for a clarification of the meaning of

``batch.'' We agree that the ``batch'' reference in proposed

Sec. 94.4(b)(4) was confusing, and have revised the last sentence in

that paragraph to delete the reference to batch.

Meat Cooked in Plastic (Sec. 94.4(b)(5))

One commenter questioned the need for the requirement that meat

cooked in plastic have a starting temperature of 25 deg.C or below. We

have determined that cooking meat as specified in Sec. 94.4(b)(5), for

at least 1.75 hours to an internal temperature of 79.4 deg.C at the

cold spot, will inactivate rinderpest or FMD virus, regardless of the

starting temperature. Therefore, we are removing the minimum starting

temperature requirement.

Two commenters questioned the requirement that meat cooked in

plastic weigh no more than 5 kilograms and no less than 2.5 kilograms.

One requested clarification; the other suggested that we specify

neither minimum nor maximum weight allowances, arguing that weight is

irrelevant if proper procedures are followed. Although it is possible

that future testing will demonstrate the irrelevance of the weight of

the meat in a flexible plastic cooking tube, we have no data on the

efficacy of the cooking process when the weight of the meat in the tube

exceeds 5 kilograms. However, we have determined that this cooking

process is efficacious whenever the meat in the tube does not exceed 5

kilograms, so that the minimum weight allowance is unnecessary.

Therefore, we are removing the requirement that meat cooked in plastic

weigh no less than 2.5 kilograms.

One commenter stated that when the cooking process is being

verified with TID's, cooking in boiling water need not be the only

alternative to cooking in a steam-fed oven for at least 1.75 hours.

While it is possible that future research may prove other methods to be

acceptable, the Animal and Plant Health Inspection Service has no data

supporting that position at this time. Therefore, we are making no

change to the rule in response to this comment.

One commenter asked that we reiterate that the use of the TID is

not required for meats (other than ground meat) when: (1) An indicator

piece is placed as prescribed in Sec. 94.4 paragraph (b)(5) (i), (ii),

or (iii); or (2) at least 50 percent of the meat cubes or slices meet

the minimum dimensions specified in Sec. 94.4 paragraph (b)(5) (i) or

(ii). This is correct.

Three commenters objected to the requirement that meat must be

``loaded and sealed into a flexible nylon cooking tube,'' in accordance

with Sec. 94.4(b)(5). All three pointed out that meat is not literally

``sealed'' into the cooking tube. They also noted that ``nylon'' is not

the only flexible plastic film commonly used for cooking tubes, and

recommended that we replace the term ``nylon'' with ``plastic.'' We

agree on both counts, and have revised the rule to require that the

meat be ``loaded into a flexible cooking tube constructed of plastic

film or other material approved by the Food Safety and Inspection

Service, U.S. Department of Agriculture.''

Inspection; Quality Control (Sec. 94.4(b)(6))

One commenter requested that we establish a procedure for

subdividing shipment lots during the inspection process, so that if any

cooked meat fails the pink juice test, only that part of the lot

identified by the same production code date would be rejected as a

result of that failure. Our regulations do not specify lot size. If an

importer identifies lots on the basis of individual production code

dates, the inspection of those lots will accord with production code

dates. We are, therefore, making no change as a result of this comment.

Another commenter recommended that we develop a standardized

certification statement for use on foreign health certificates

accompanying the cooked meat. We are revising Sec. 94.4(b)(6) to

require that the certificate issued by an official of the National

Government of the exporting country state: ``This cooked meat produced

for export to the United States meets the requirements of title 9, Code

of Federal Regulations, Sec. 94.4(b).''

Several commenters asked whether the TID's gauging the temperature

of each batch of cooked meat would have to accompany that meat to the

United States and, if so, whether they should remain in the meat, as

originally inserted. We have added a new paragraph 94.4(b)(6) to make

clear that each TID used in accordance with Sec. 94.4 (b)(4) or (b)(5)

must remain in the meat, as originally inserted, and must accompany the

batch of cooked meat whose temperature it has gauged when that meat is

shipped to the United States.

Thermal Processing Equipment (Sec. 94.4(c)(2)(i))

One commenter objected to the proposed requirement that facilities

used for processing cooked meat and facilities used for processing raw

meat be connected only by the terminal end of the oven through which

the meat product is delivered at the end of the cooking cycle. The

commenter noted that such a requirement assumes that the continuous

belt oven is the only thermal processing oven system with the capacity

to inactivate the rinderpest or FMD virus, ignoring other through-the-

wall cooking systems, such as the water-tunnel locked system. We regret

our oversight, and are changing the requirement to provide that the

facilities for processing cooked meat and the facilities for processing

raw meat be connected by a through-the-wall cooking system.

Miscellaneous

One commenter questioned the need for port-of-entry inspection of

cooked meat that has been processed in accordance with the regulations,

under the supervision of a full-time salaried meat inspection official

of the national government of the country of origin, and, therefore,

been issued a certificate in accordance with Sec. 94.4(b)(7)

(designated as Sec. 94.4(b)(6) in the proposed rule). The port-of-entry

inspection that is conducted in accordance with newly redesignated

Sec. 94.4(b)(8) serves as insurance that the shipments meet all

requirements of the regulations. Therefore, we are making no change in

response to this comment.

In the proposed rule, we specified that slices of meat (including

slices of anatomical cuts of meat) must be a minimum of 3.8 centimeters

in two directions. We have become aware of confusion about the size of

the third direction, and have therefore revised the wording of

Sec. 94.4 paragraphs (b)(5) (ii) and (iii) to clarify that a slice of

meat must be at least as broad and long as it is thick. Therefore, we

are specifying that a slice be a minimum of 3.8 centimeters in each

direction.

Therefore, based on the rationale set forth in the proposed rule

and in this document, we are adopting the provisions of the proposal as

a final rule, with the changes discussed in this document.

Executive Order 12866 and Regulatory Flexibility Act

This rule has been determined to be not significant for purposes of

Executive Order 12866 and therefore has not been reviewed by the Office

of Management and Budget.

Since most of the meat processing establishments expressing

interest in exporting cooked ground meat already have the capacity to

meet U.S. requirements, the regulations are unlikely to increase the

cost burden on foreign exporters or, indirectly, on U.S. importers. The

only additional costs that the operators of the meat processing

establishments will incur will be those covering the expenses for an

APHIS representative to inspect the establishment at approximately 2-

year intervals. Approximately $4,000 is the amount expected to cover

the cost of one inspection by an APHIS veterinarian, including travel,

salary, subsistence, administrative overhead, and other incidental

expenses. Compared to the potential value of exports and new business,

the effect of this additional cost will be minimal.

In recent years, moderate amounts of processed meat, particularly

various cuts of cooked beef, have been imported into the United States

from countries where rinderpest or FMD exists. In 1990, approximately

45 million pounds of cooked beef were imported from three such

countries (Argentina, Brazil, and Uruguay). During the same period,

approximately 621 million pounds of cooked beef and 631 million pounds

of cooked ground meat were produced in the United States.

Because of the inapplicability of the pink juice test to certain

meat products, there are currently no commercial importations into the

United States of cooked ground meat from countries where rinderpest or

FMD exists. However, several importers have advised us of their intent

to import cooked ground beef after the effective date of this rule. One

of these importers is considered a small entity. This importer

anticipates a steady but small volume of shipments of cooked ground

beef from countries where rinderpest or FMD exists.

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 12778

This rule has been reviewed under Executive Order 12778, 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

In accordance with the Paperwork Reduction Act of 1980 (44 U.S.C.

3501 et seq.), the information collection or recordkeeping requirements

included in this final rule will be submitted for approval to the

Office of Management and Budget.

List of Subjects in 9 CFR Part 94

Animal diseases, Imports, Livestock, Meat and meat products, Milk,

Poultry and poultry products, Reporting and recordkeeping requirements.

Accordingly, 9 CFR part 94 is amended as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL

PLAGUE), VELOGENIC VISCEROTROPIC 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, 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, 4332; 7 CFR 2.17, 2.51, and 371.2(d).

2. In Sec. 94.0, the following definitions are added, in

alphabetical order, and the definition of Thoroughly cooked is revised,

to read as follows:

Sec. 94.0 Definitions.

* * * * *

Cold spot. The area in a flexible plastic cooking tube or other

type of container loaded with meat product, or the areas at various

points along the belt in an oven chamber, slowest to reach the required

temperature during the cooking process. The cold spot(s) for each

container is experimentally determined before the cooking process

begins, and once identified, remains constant.

* * * * *

Indicator piece. A cube or slice of meat to be used for the pink

juice test, required to meet minimum size specifications.

* * * * *

Temperature indicator device (TID). A precalibrated temperature-

measuring instrument containing a chemical compound activated at a

specific temperature (the melting point of the chemical compound)

identical to the processing temperature that must be reached by the

meat being cooked. The Administrator will approve a TID for use after

determining that the chemical compound in the device is activated at

the specific temperature required.

Thoroughly cooked. Heated sufficiently to inactivate any pathogen

that may be present, as indicated by the required TID or pink juice

test.

* * * * *

Sec. 94.1 [Amended]

3. In Sec. 94.1, paragraph (c)(1) is amended by removing ``maat''

and adding ``meat'' in its place.

4. In Sec. 94.4, footnote 1 is removed; paragraphs (b) introductory

text, (b)(1), and (b)(2) are revised; paragraph (b)(3) is redesignated

as paragraph (b)(8); footnotes 2 and 3 are redesignated as footnotes 1

and 2; a new paragraph (b)(3) is added; paragraph (b)(4) is revised;

paragraphs (b)(5), (b)(6), and (b)(7) are added; and paragraph (c) is

added, to read as follows:

Sec. 94.4 Cured or cooked meat from countries where rinderpest or

foot-and-mouth disease exists.

* * * * *

(b) The importation of cooked meat from ruminants or swine

originating in any country where rinderpest or foot-and-mouth disease

exists, as designated in Sec. 94.1, is prohibited, except as provided

in this section.

(1) The cooked meat must be boneless and must be thoroughly cooked.

(2) The cooked meat must have been prepared in an establishment

that is eligible to have its products imported into the United States

under the Federal Meat Inspection Act (21 U.S.C. 610 et seq.) and the

regulations in 9 CFR 327.2; must meet all other applicable requirements

of the Federal Meat Inspection Act and regulations thereunder (9 CFR

Chapter III); and must have been approved by the Administrator in

accordance with paragraph (c) of this section.

(3) Canned product (canned meat), as defined in Sec. 318.300(d) of

this chapter, is exempt from the requirements in this section.

(4) Ground meat cooked in an oven. Ground meat must be shaped into

patties no larger than 5 inches in diameter and 1-inch thick. Each

patty must weigh no more than 115 grams, with fat content no greater

than 30 percent. These patties must be broiled at 210 deg.C for at

least 133 seconds, then cooked in moist heat (steam heat) in a

continuous, belt-fed oven for not less than 20 minutes, to yield an

internal exit temperature of at least 99.7 deg.C, as measured by

temperature indicator devices (TID's) placed in temperature monitor

patties positioned, before the belt starts moving through the oven, on

each of the predetermined cold spots along the oven belt. TID's must be

used at the beginning of each processing run.

(5) Meat cooked in plastic. The ground meat, cubes of meat, slices

of meat, or anatomical cuts of meat (cuts taken from the skeletal

muscle tissue) must weigh no more than 5 kilograms, and must be loaded

into a flexible cooking tube constructed of plastic film or other

material approved by the Food Safety and Inspection Service, U.S.

Department of Agriculture. The meat must be cooked in boiling water or

in a steam-fed oven to reach a minimum internal temperature of 79.4

deg.C at the cold spot after cooking for at least 1.75 hours.

Thoroughness of cooking must be determined by the TID registering at

least 79.4 deg.C at the cold spot, or by the pink juice test, as

follows:

(i) Cubes of meat. At least 50 percent of meat pieces per tube must

be 3.8 centimeters or larger in each dimension after cooking or, if

more than 50 percent of meat pieces per tube are smaller than 3.8

centimeters in any dimension after cooking and no TID is being used, an

indicator piece of sufficient size for a pink juice test to be

performed (3.8 centimeters or larger in each dimension after cooking)

must have been placed at the cold spot of the tube.

(ii) Slices of meat. At least 50 percent of the slices of meat must

be 3.8 centimeters or larger in each dimension after cooking or, if

more than 50 percent of meat pieces are smaller than 3.8 centimeters in

any dimension after cooking, and no TID is being used, an indicator

piece of sufficient size for a pink juice test to be performed (3.8

centimeters or larger in each dimension after cooking) must be placed

at the cold spot of the tube.

(iii) Anatomical cuts of meat. An indicator piece removed from an

anatomical cut of meat after cooking must be removed from the center of

the cut, farthest from all exterior points and be 3.8 centimeters or

larger in each dimension for performance of the pink juice test.

(6) Any TID used in accordance with Sec. 94.4 (b)(4) or (b)(5) must

remain in the meat, as originally inserted, and must accompany the

cooked meat whose temperature it has gauged when that meat is shipped

to the United States.

(7) The cooked meat must be accompanied by a certificate issued by

an official of the national government of the country of origin, who is

authorized to issue the foreign meat inspection certificate required by

Sec. 317.4 of this title, stating: ``This cooked meat produced for

export to the United States meets the requirements of title 9, Code of

Federal Regulations, Sec. 94.4(b).'' Upon arrival of the cooked meat in

the United States, the certificate must be presented to an authorized

inspector at the port of arrival.

* * * * *

(c) Meat processing establishment; standards. (1) Before the

Administrator will approve a meat processing establishment for export

shipment of cooked meat to the United States, the Administrator must

determine:

(i) That the meat processing establishment has furnished APHIS with

a description of the process used to inactivate rinderpest or FMD virus

that may be present in meat intended for export to the United States,

and with blueprints of the facilities where this meat is cooked and

packaged;

(ii) That an APHIS representative has inspected the establishment

and found that it meets the standards set forth in paragraph (c)(2) of

this section;

(iii) That the operator of the establishment has signed a

cooperative service agreement with APHIS, stating: (A) That all cooked

meat processed for importation into the United States will be processed

in accordance with the requirements of this part; (B) that a full-time,

salaried meat inspection official of the National Government of the

exporting country will supervise the processing (including

certification of the cold spot) and examination of the product, and

certify that it has been processed in accordance with this section; and

(C) that APHIS personnel or other persons authorized by the

Administrator may enter the establishment, unannounced, to inspect the

establishment and its records; and

(iv) That the operator of the establishment has entered into a

trust fund agreement with APHIS and is current in paying all costs for

an APHIS representative to inspect the establishment for initial

evaluation, and periodically thereafter, including travel, salary,

subsistence, administrative overhead, and other incidental expenses

(including an excess baggage provision up to 150 pounds). In accordance

with the terms of the trust fund agreement, before the APHIS

representative's site inspection, the operator of the processing

establishment must deposit with the Administrator an amount equal to

the approximate cost of one inspection by an APHIS representative,

including travel, salary, subsistence, administrative overhead, and

other incidental expenses (including an excess baggage provision up to

150 pounds). As funds from that amount are obligated, a bill for costs

incurred based on official accounting records will be issued, to

restore the deposit to the original level, revised as necessary to

allow for inflation or other changes in estimated costs. To be current,

bills must be paid within 14 days of receipt.

(2) Establishment. An APHIS representative will conduct an on-site

evaluation, and subsequent inspections, as provided in Sec. 94.4(c)(1),

to determine whether the following conditions are met:

(i) The facilities used for processing cooked meat in the meat

processing establishment are separate from the facilities used for

processing raw meat (precooking, boning, preparation, and curing), with

only the through-the-wall cooking system through which the meat product

is delivered at the end of the cooking cycle connecting them; and there

is at all times a positive air flow from the cooked to the raw product

side;

(ii) The cooking equipment has the capacity to cook all meat pieces

in accordance with Sec. 94.4 (b)(4) or (b)(5);

(iii) Workers who process cooked meat are at all times kept

separate from workers who process raw meat, and have, for their

exclusive use: A separate entrance, dining area, toilets, lavatories

with cold and hot water, soap, disinfectants, paper towels, clothes

hampers and waste baskets for disposal, and changing rooms stocked with

the clean clothing and rubber boots into which all persons must change

upon entering the establishment. Workers and all other persons entering

the establishment must wash their hands and change into the clean

clothing and boots provided in the changing rooms before entering the

cooking facilities, and must leave this clothing for laundering and

disinfecting before exiting from the establishment, regardless of the

amount of time spent inside or away from the establishment;

(iv) Original records identifying the slaughtering facility from

which the meat was obtained and the date the meat entered the meat

processing establishment, and original certification (including

temperature recording charts and graphs), must be kept for all cooked

meat by the full-time salaried meat inspection official of the National

Government of the exporting country assigned to the establishment, and

must be retained for 2 years.

Done in Washington, DC, this 15th day of March 1994.

Patricia Jensen,

Assistant Secretary, Marketing and Inspection Services.

[FR Doc. 94-6548 Filed 3-18-94; 8:45 am]

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