[Federal Register Volume 59, Number 54 (Monday, March 21, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-6548]


[[Page Unknown]]

[Federal Register: March 21, 1994]


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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]
BILLING CODE 3410-34-P