[Federal Register Volume 68, Number 178 (Monday, September 15, 2003)]
[Rules and Regulations]
[Pages 53873-53877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23431]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 02-003-2]


Importation of Pork-Filled Pasta

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the regulations regarding the importation of 
pork and pork products from regions affected with swine vesicular 
disease by establishing procedures for the importation of pork-filled 
pasta into the United States. The procedures require that the product 
contain only cooked or dry-cured pork otherwise eligible to enter the 
United States under the regulations; that the operator of any pork-
filled pasta processing facility processing products for export to the 
United States enter into a cooperative service agreement with the 
Animal and Plant Health Inspection Service providing for unannounced 
inspections of the facility which are to be paid for by the facility; 
that the product not be commingled, directly or indirectly, with 
products ineligible to enter the United States; and that the product be 
accompanied by an official veterinary certificate confirming that the 
product has been prepared in accordance with the regulations. This 
action provides for the importation of pork-filled pasta under 
conditions designed to prevent the introduction of swine vesicular 
disease into the United States.

EFFECTIVE DATE: September 15, 2003.

FOR FURTHER INFORMATION CONTACT: Dr. Masoud Malik, Senior Staff 
Veterinarian, Technical Trade Services, National Center for Import and 
Export, VS, APHIS, 4700 River Road Unit 40, Riverdale, MD 20737-1231; 
(301) 734-3277.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in 9 CFR part 94 (referred to below as the 
regulations) prohibit or restrict the importation of specified animals 
and animal products into the United States to prevent the introduction 
into the U.S. livestock population of certain contagious animal

[[Page 53874]]

diseases, including swine vesicular disease (SVD). Section 94.12 of the 
regulations contains requirements for the importation into the United 
States of pork and pork products from regions where SVD is known to 
exist. Section 94.17 of the regulations contains requirements for the 
importation into the United States of dry-cured pork products from 
regions where SVD, classical swine fever (CSF), foot-and-mouth disease 
(FMD), rinderpest, and African swine fever exist.
    SVD is a highly contagious disease caused by an enterovirus that 
shows extraordinary resistance to both environmental factors and common 
disinfectants. SVD rarely results in mortality in infected swine and 
does not cause severe production losses. Still, the disease can have a 
major economic impact because eradication is costly and because SVD-
free regions often prohibit imports of swine, pork, and pork products 
from affected regions.
    Certain regions in Italy are considered to be affected with SVD and 
thus are not among those regions designated in Sec.  94.12 as free of 
the disease. Similarly, certain regions in Italy are not included among 
the regions designated in Sec. Sec.  94.9 and 94.10 as free of CSF. 
Therefore, cooked and dry-cured pork and pork products imported from 
certain regions in Italy are subject to the requirements in Sec. Sec.  
94.12 and 94.17.
    On January 21, 2003, we published in the Federal Register (68 FR 
2711-2714, Docket No. 02-003-1) a proposal to amend the regulations in 
Sec.  94.12 by establishing procedures for the importation of pork-
filled pasta into the United States from regions affected with SVD. The 
proposed procedures required that the product contain only cooked or 
dry-cured pork otherwise eligible to enter the United States under the 
regulations; that the product not be commingled, directly or 
indirectly, with products ineligible to enter the United States; and 
that the product be accompanied by an official veterinary certificate 
confirming that the product was prepared in accordance with the 
regulations.
    We solicited comments concerning our proposal for 60 days ending 
March 24, 2003. We received four comments by that date. They were from 
foreign and domestic producers and representatives of the Government of 
Italy. All the commenters favored the proposed rule in its broad 
outlines, but three of the four requested that we modify certain 
provisions, arguing that the same level of protection against the 
introduction of SVD into the United States could be achieved in less 
intrusive ways. The comments are discussed below by topic.
    Commenters pointed out that certain of the proposed requirements 
assumed that the pork-filled pasta would be produced in a facility used 
both for products eligible for export to the United States and those 
not eligible for export to the United States. (Such multi-use 
facilities are referred to as ``non-dedicated facilities.'') The 
commenters specifically cited the requirements pertaining to storage 
areas for pork for pork-filled pasta products, cleaning and 
disinfection of machinery, and restricted use of processing lines, 
which were contained, respectively, in proposed Sec.  94.12(c)(2) 
through (c)(4). The commenters maintained that the final rule should 
also provide for products produced in a dedicated facility that would 
produce only pork-filled pasta products eligible for export to the 
United States. The commenters suggested that the provisions of proposed 
paragraphs (c)(2) through (c)(4) would be irrelevant to such a 
dedicated facility, which should, therefore, be exempted from them.
    We agree with the commenters that dedicated processing facilities 
that are exempt from the requirements in proposed paragraphs (c)(2) 
through (c)(4) can safely provide pork-filled pasta products for the 
U.S. market, and are providing for such an exemption in a new Sec.  
94.12(c)(7).
    The commenters also urged that we modify the requirements contained 
in proposed Sec.  94.12(c)(2) for the storage of pork intended for use 
in pork-filled pasta products for export to the United States. This 
paragraph stated that, at the pasta processing establishment, pork 
intended to be used for pork-filled pasta products for export to the 
United States must be stored in a separate room or facility from any 
meat or meat products not eligible for export to the United States. The 
commenters contended that an equivalent level of protection could be 
provided by storing U.S.-import-eligible pork in a dedicated area 
within existing refrigerated storage cells rather than in fully 
dedicated cells, provided these areas are separated by at least 1 meter 
from areas where ineligible meat is stored, marked with signs, and have 
their borders outlined on the floor. The commenters noted that the 
Animal and Plant Health Inspection Service (APHIS) has already adopted 
this approach for use in Italian prosciutto plants that are eligible to 
export their products to the United States under Sec. Sec.  94.12 and 
94.17.
    The commenters also suggested that we modify proposed Sec.  
94.12(c)(4), which stated that processing lines working with pork-
filled pasta products for export to the United States must process only 
pasta containing pork eligible for such exportation and that, when such 
processing lines are working with pasta products containing pork for 
export to the United States, other lines may work only on pasta 
products that do not contain meat. Again citing APHIS' practices in 
regard to Italian proscuitto plants, the commenters asserted that the 
cleaning and disinfection requirements set forth in proposed Sec.  
94.12(c)(3) were sufficient to prevent contamination of pork intended 
for the U.S. market and that requiring dedicated processing lines was 
unnecessary. The commenters recommended that, instead of requiring 
dedicated processing lines, the regulations require dedicated 
processing times, which the commenters said would be a less costly and 
intrusive but equally effective way to guard against commingling. 
Specifically, they proposed that a production line be dedicated to 
producing pork-filled pasta products for export to the United States 
only for the time necessary to complete a lot destined for the U.S. 
market, and that, when any line in the facility was processing such a 
lot, no other processing lines in the same facility be allowed to 
process products using meat that is not eligible for export to the 
United States. The commenters stated that these changes would allow the 
entire facility to be dedicated to producing pork-filled pasta products 
for export to the United States for the time needed to produce a 
specified amount of such products and then to be used to make other 
products.
    We are incorporating the changes recommended by the commenters into 
our final rule. If strictly adhered to, the suggested provisions will 
prevent the introduction of SVD into the United States via imports of 
pork-filled pasta products from affected regions, while offering 
processors greater flexibility in the utilization of their facilities 
than the corresponding paragraphs in the proposed rule would have. 
However, to ensure that these changes will not increase the risk of 
introducing SVD into the United States, we consider it necessary to 
augment some of the requirements of the proposed rule.
    We consider a more rigorous inspection requirement than that 
prescribed in the proposed rule to be necessary to ensure that 
processors comply with the regulations. The proposed rule, in Sec.  
94.12(c)(6), provided for periodic inspections of processing facilities 
and their records and operations by APHIS inspectors. In place of that 
general requirement, this final rule describes the terms of a 
cooperative service agreement, modeled on similar provisions for 
certain

[[Page 53875]]

imported dry cured pork products in Sec.  94.17, that the pork-filled 
pasta processing establishment must enter into with APHIS prior to 
receiving pork for use in pork-filled pasta products intended for 
export to the United States. In order for APHIS to verify that 
dedicated processing facilities are, in fact, producing only pork-
filled pasta products for export to the United States and that non-
dedicated facilities are complying with all applicable provisions of 
the regulations, both types of facilities will be required to enter 
into such agreements. Under the terms of the cooperative service 
agreement, the establishment must state that all such pork will be 
processed only in accordance with Sec.  94.12 or Sec.  94.17; must 
allow the unannounced entry into the establishment of APHIS 
representatives, or other persons authorized by the Administrator, for 
the purpose of inspecting the facilities, operations, and records of 
the establishment; and must be current in paying all costs for such 
inspections, which may occur up to four times per year. The costs to be 
covered by the processing establishment include those for travel, 
salary, subsistence, administrative overhead, and other incidental 
expenses (including an excess baggage provision up to 150 pounds). The 
operator of the processing establishment must deposit with the 
Administrator an amount equal to the approximate costs for APHIS to 
inspect the establishment one time, and as funds from that amount are 
obligated, bills for costs incurred based on official accounting 
records will be issued to restore the deposit to its original level. 
Amounts to restore the deposit to its original level must be paid 
within 14 days of receipt of such bills. These provisions are contained 
in a new Sec.  94.12(c)(2) of this final rule.
    Because this final rule, unlike the proposed rule, allows pork for 
pork-filled pasta products intended for export to the United States to 
be stored in the same room as meat and meat products that are 
ineligible for export to the United States, we determined that we 
needed to provide greater protection against the risk that workers 
handling both types of products could contaminate those eligible for 
export to the United States. We are, therefore, adding a provision to 
require that, prior to handling pork used for pork-filled pasta 
products intended for export to the United States, workers at the 
processing facility who handle pork or pork products in the facility 
shower and put on a full set of clean clothes, or wait 24 hours after 
handling pork or pork products that are not eligible for importation 
into the United States. This provision is contained in a new Sec.  
94.12(c)(4) of this final rule.
    By incorporating these new handling and cooperative service 
agreement requirements, as well as the modifications proposed by the 
commenters, this final rule will provide for the safe importation of 
pork-filled pasta products from SVD-affected regions while allowing 
processors maximal flexibility in the use of their facilities.
    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.

Effective Date

    This is a substantive rule that relieves restrictions and, pursuant 
to the provisions of 5 U.S.C. 553, may be made effective less than 30 
days after publication in the Federal Register.

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 the regulations in Sec.  94.12 that deal with the 
importation of pork and pork products from regions affected with SVD by 
establishing procedures for the safe importation of pork-filled pasta 
into the United States from SVD-affected regions in Italy and 
elsewhere. These procedures will allow the importation of this product 
into the United States while ensuring that the health of the U.S. swine 
population and the economic viability of the U.S. swine and pork and 
pork products industries will not be threatened by an incursion of SVD.
    These industries play an important role in the U.S. economy. There 
was a total inventory of 58.698 million swine in the United States as 
of March 1, 2002.\1\ Cash receipts from swine farming in 2001 were 
about $12.1 billion.\2\ The industry marketed 26.7 billion pounds of 
pork in 2001. Additionally, the United States earned a substantial 
amount of money from exports of swine and swine products. The United 
States exported 1.075 billion pounds of pork, valued at $1.283 billion, 
in 2001. Also 64,912 live swine were exported, which were valued at 
about $12 million. The United States also imported 717 million pounds 
of pork in 2001, valued at $771 million, and imported 5,337,088 live 
swine, all from Canada, valued at $349 million. Domestically, other 
related agricultural and nonagricultural sectors are dependent on the 
swine and the swine-product industries for their economic activity. 
These activities provide employment and income to many households. 
Maintaining the stability of these industries depends in part on 
continued efforts to prevent any introduction of SVD into the United 
States.
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    \1\ USDA/NASS, Quarterly Hogs and Pigs, Agricultural Statistics 
Board, March 2002.
    \2\ USDA/ERS, U.S. farm sector cash receipts from sales of 
agricultural commodities, 1998-2002, February 2002.
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    The Regulatory Flexibility Act requires that agencies specifically 
consider the economic impact of their rules on small entities. The 
domestic entities most likely to be affected by allowing importation of 
pork-filled pasta products from regions in Italy affected with SVD are 
durum wheat producers and pasta manufacturing companies.
    In 1997, 6,887 farms, over 99 percent of which were considered 
small,\3\ produced about 5.160 billion pounds of durum wheat.\4\ In 
2001, durum wheat production was estimated at about 5.013 billion 
pounds on 2.789 million harvested acres.\5\ In 2001, the United States 
exported 3 billion pounds of durum wheat, valued at $215 million. The 
major destinations were Italy (39 percent), Tunisia (10 percent), 
Algeria (9 percent), and Mexico (7 percent).\6\
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    \3\ North American Industry Classification System (NAICS) code 
111140, Wheat Farming. The Small Business Administration has 
established guidelines for determining which types of firms are to 
be considered small under the Regulatory Flexibility Act. A wheat 
farm is considered small if it has annual receipts of $750,000 or 
less.
    \4\ USDA/NASS, 1997 Census of Agriculture (for AZ, CA, MN, MT, 
ND, and SD). These are durum wheat-producing States.
    \5\ USDA/NASS, Crop Production 2001 Summary, Agricultural 
Statistics Board, January 2002.
    \6\ Global Trade Information Services, Inc., World Trade Atlas, 
United States Edition, December 2001.
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    As a new product, dry, shelf-stable, pork-filled tortellini is 
expected to have a small market. The economic impact, if any, on durum 
wheat producers as a result of importation of this product into the 
United States is also likely to be small. Producers of durum wheat 
could benefit in the future from any expansion of product range that 
results from these imports.
    There were 141 pasta manufacturing plants in the United States in 
2000. Of these, 5 companies accounted for 55 percent of the sales. The 
total domestic capacity is estimated to be about 3.4 billion pounds of 
pasta.\7\ Pasta

[[Page 53876]]

producers are considered small businesses if they employ 500 workers or 
fewer.\8\ Most U.S. pasta manufacturers can be considered small.
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    \7\ Michael Boland and David Barton, ``How Dakota Growers Pasta 
co-op found success in a highly competitive market,'' July 2001 
(http://www.rurdev.usda.gov/rbs/pub/jul01/niche.htm). About 80 
million bushels of durum wheat were allocated for food use in 2001. 
Assuming a bushel of wheat yields 42 pounds of pasta, the amount of 
wheat in food use equals 3,360 million pounds of pasta.
    \8\ NAICS code 311823, dry pasta manufacturers.
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    Compared to total imports of pasta, valued at $324 million in 2001, 
imports of stuffed pasta make up a relatively small proportion.\9\ 
Additionally, tortellini is just one of the many varieties of stuffed 
pasta. Other varieties include agnolotti, calazoncelli, cappelletti, 
fazzoletti, ravioli, and tordelli. Each of these has variations, 
depending on whether the filling ingredients are fish-based, ground 
meat, vegetables, cheese, mushrooms, or herbs and spices. Although 
information on the exact amount of each type imported is not available, 
the share of each is likely to be small.
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    \9\ Global Trade Information Services, Inc., World Trade Atlas, 
United States Edition, December 2001.
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    As a new variant of these products, dry, shelf-stable, pork-filled 
tortellini is also likely to have a small market. Imports of this 
product are likely to be too small to have any price effect at the 
industry level. No direct price competition can be expected when 
imports are initiated because there are no known domestic producers of 
pork-filled tortellini. Price competition with other filled pasta 
products is also considered unlikely because, as a new product with a 
small market, pork-filled tortellini is unlikely to have a major effect 
on consumer demand for those other products. Allowing imports of pork-
filled tortellini may eventually stimulate new competition by 
encouraging domestic pasta manufacturers to develop a similar product. 
Consumers may also benefit from having their choices of pasta products 
expanded.
    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

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.), the information collection or recordkeeping requirements 
included in this rule have been approved by the Office of Management 
and Budget (OMB) under OMB control number 0579-0214.

Government Paperwork Elimination Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the Government Paperwork Elimination Act (GPEA), which 
requires Government agencies in general to provide the public the 
option of submitting information or transacting business electronically 
to the maximum extent possible. For information pertinent to GPEA 
compliance related to this rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 734-7477.

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.

0
Accordingly, we are amending 9 CFR part 94 as follows:

PART 94--RINDERPEST, FOOT-AND-MOUTH DISEASE, FOWL PEST (FOWL 
PLAGUE), EXOTIC NEWCASTLE DISEASE, AFRICAN SWINE FEVER, CLASSICAL 
SWINE FEVER, AND BOVINE SPONGIFORM ENCEPHALOPATHY: PROHIBITED AND 
RESTRICTED IMPORTATIONS

0
1. The authority citation for part 94 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 8301-8317; 21 U.S.C. 136 
and 136a; 31 U.S.C. 9701; 42 U.S.C. 4331 and 4332; 7 CFR 2.22, 2.80, 
and 371.4.

0
2. In Sec.  94.12, a new paragraph (c) is added and the OMB control 
number citation at the end of the section is revised to read as 
follows:


Sec.  94.12  Pork and pork products from regions where swine vesicular 
disease exists.

* * * * *
    (c) Requirements for pork-filled pasta products from regions 
affected with swine vesicular disease. (1) Pork-filled pasta products 
processed for export to the United States may only be filled with pork 
or pork products that are otherwise eligible to be exported to the 
United States and that meet the requirements of paragraph (b)(1)(i), 
(ii), or (v) of this section or of Sec.  94.17.
    (2) The operator of the pork-filled pasta processing facility must 
have signed a cooperative service agreement with APHIS prior to receipt 
of the pork intended to be used in pork-filled pasta products, stating 
that all such pork will be processed only in accordance with Sec.  
94.12 or Sec.  94.17. Pursuant to the cooperative service agreement, 
the establishment must allow the unannounced entry into the 
establishment of APHIS representatives, or other persons authorized by 
the Administrator, for the purpose of inspecting the facilities, 
operations, and records of the establishment. The establishment must be 
current in paying all costs for such inspections (it is anticipated 
that such inspections will occur up to four times per year). These 
costs include 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 cooperative service 
agreement, the operator of the processing establishment must deposit 
with the Administrator an amount equal to the approximate costs for 
APHIS to inspect the establishment one time, including travel, salary, 
subsistence, administrative overhead and other incidental expenses 
(including an excess baggage provision up to 150 pounds), and, as funds 
from that amount are obligated, bills for costs incurred based on 
official accounting records will be issued to restore the deposit to 
its original level. Amounts to restore the deposit to its original 
level must be paid within 14 days of receipt of such bills.
    (3) At the pasta processing establishment, pork intended to be used 
for pork-filled pasta products for export to the United States must be 
stored apart from any meat or meat products not eligible for export to 
the United States, either in a separate storage room or facility or in 
a separate area of the same storage room. Any storage room area 
reserved for pork or pork products eligible for export to the United 
States must be separated by at least 1 meter from any storage room area 
where meat or meat products ineligible for export to the United States 
are stored and must be marked by signs and by having its borders 
outlined on the floor.
    (4) Prior to handling pork used for pork-filled pasta products 
intended for export to the United States, workers at the processing 
facility who handle pork or pork products in the facility must shower 
and put on a full set of clean clothes, or wait 24 hours after handling 
pork or pork products that are not

[[Page 53877]]

eligible for importation into the United States.
    (5) All equipment and machinery that will come in contact with the 
pork or other ingredients of pork-filled pasta products intended for 
export to the United States must be cleaned and disinfected before each 
use.
    (6) Processing lines working with pork-filled pasta products for 
export to the United States must be totally dedicated to the production 
of such products for the time needed to complete a given lot. When any 
processing line in a facility is working with pork-filled pasta 
products intended for export to the United States, no other processing 
lines in the same facility may work on products using meat that is not 
eligible for export to the United States.
    (7) Processing facilities that are completely dedicated to 
producing only pork-filled pasta products for export to the United 
States and do not receive, handle, or process any animal product not 
intended for export to the United States are exempt from the 
requirements of paragraphs (c)(3) through (c)(6) of this section.
    (8) During processing, the pork-filled pasta must be steam-heated 
to a minimum internal temperature of 90 [deg]C, then dried, cooled, and 
packed to make the product shelf stable without refrigeration.
    (9) The processing facility must maintain under lock and key, for a 
minimum of 2 years, an original record of each lot of pork or pork 
products used for pork-filled pasta products for export to the United 
States. Each record must include the following:
    (i) The date that the cooked or dry-cured pork product was received 
in the processing facility;
    (ii) The number of packages, the number of hams or cooked pork 
products per package, and the weight of each package;
    (iii) A lot number or other identification marks;
    (iv) The health certificate that accompanied the cooked or dry-
cured pork product from the slaughter/processing facility to the meat-
filled pasta product processing facility; and
    (v) The date that the pork or pork product used in the pasta 
started dry curing (if the product used is a dry-cured ham) or the date 
that the product was cooked (if the product used is a cooked pork 
product).
    (10) The pork-filled pasta must be accompanied by a certificate 
issued by an official of the National Government of the region in which 
the pasta product is processed who is authorized to issue the foreign 
meat inspection certificate required under Sec.  327.4 of this title, 
stating that the pork-filled pasta product has been processed in 
accordance with the requirements of this section.
    Upon arrival of the pork-filled pasta in the United States, the 
certificate must be presented to an inspector at the port of arrival.

(Approved by the Office of Management and Budget under control 
numbers 0579-0015 and 0579-0214)


    Done in Washington, DC, this 8th day of September 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-23431 Filed 9-12-03; 8:45 am]
BILLING CODE 3410-34-P