[Federal Register Volume 68, Number 13 (Tuesday, January 21, 2003)]
[Proposed Rules]
[Pages 2711-2714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1213]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 94

[Docket No. 02-003-1]


Importation of Pork-Filled Pasta

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend 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 proposed procedures would 
require that the product contain only cooked or dry-cured pork 
otherwise eligible to enter the United States under the current 
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 has been prepared in accordance with the 
regulations. This action would provide for the importation of pork-
filled pasta under conditions designed to prevent the introduction of 
swine vesicular disease into the United States.

DATES: We will consider all comments that we receive on or before March 
24, 2003.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 02-003-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 02-003-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
02-003-1'' on the subject line.
    You may read any comments that we receive on this docket in our 
reading room. The reading room is located in room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW., Washington, 
DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 690-2817 before coming.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.

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 39, 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 
diseases, including swine vesicular disease (SVD). Section 94.12 of the 
regulations provides 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 provides requirements for the 
importation into the United States for dry-cured pork products from 
regions where SVD, hog cholera (also known as classical swine fever), 
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.
    Italy is considered to be affected with SVD and thus is not among 
those regions designated in Sec.  94.12 as free of the disease. 
Similarly, Italy is not included among the regions designated in 
Sec. Sec.  94.9 and 94.10 as free of hog cholera. Therefore, cooked and 
dry-cured pork and pork products imported from Italy are subject to the 
requirements set forth in Sec. Sec.  94.12 and 94.17.
    The Italian Government has requested that facilities in Italy be 
allowed to export to the United States tortellini (pasta) that is 
filled with pork. In order to allow this product to enter the United 
States without increasing the risk of the introduction of SVD, we are 
proposing to amend Sec.  94.12 to establish procedures that processing 
facilities in SVD-affected regions would have to follow to ensure that 
this particular product would be safe to import into the United States. 
While a specific request from Italy provided the impetus for this 
proposed rule, the requirements we are proposing would apply to pork-
filled pasta products imported into the United States from any region 
affected by SVD.
    Specifically, we are proposing to add a new paragraph (c) to Sec.  
94.12 that would delineate processing, recordkeeping, and certification 
requirements for pork-filled pasta products exported to the United 
States from SVD-affected regions. Paragraph (c)(1) would stipulate that 
pork-filled pasta products processed for export to the United States 
would have to contain only pork or pork products that are otherwise 
eligible for importation into the United States, i.e., that meet all 
requirements that apply to cooked pork products under Sec.  94.12 
(b)(1)(i), (ii), or (v)\1\ or to dry-cured pork products under Sec.  
94.17.
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    \1\ While pork and pork products that meet the requirement of 
Sec.  94.12(b)(1)(iii) and (iv) are also eligible for importation 
into the United States, proposed paragraph (c)(1) would not provide 
for their use in pork-filled pasta products. As neither paragraph 
requires the pork or pork products to be fully processed in the 
region of origin, such pork and pork products are not suitable for 
inclusion in a completed product such as pork-filled pasta.
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    The provisions of proposed paragraphs (c)(2), (c)(3), and (c)(4) 
are intended to prevent contamination via the commingling of ineligible 
pork or other meat products with pork or pork products eligible for use 
in pork-filled pasta products for export to the United States. 
Paragraph (c)(2) would stipulate that pork intended to be used for 
pork-filled pasta products for export to the

[[Page 2712]]

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. 
Paragraph (c)(3) would state that 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. Paragraph (c)(4) would state that 
processing lines working with pork-filled pasta products for export to 
the United States must process only pasta containing pork eligible for 
such exports and that when such lines are working with these pasta 
products, the remaining lines may work only on pasta products that do 
not contain meat.
    Paragraph (c)(5) would set out cooking and other requirements for 
pork-filled pasta being exported to the United States to ensure that 
the product would be shelf stable without refrigeration. Specifically, 
we would require that during processing, the pork-filled pasta would 
have to 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.
    Paragraph (c)(6) would give the Animal and Plant Health Inspection 
Service the right to conduct periodic inspections of establishments 
that manufacture pork-filled pasta products for export to the United 
States in order to verify compliance by these establishments with the 
regulations in this section.
    Paragraph (c)(7) would set out recordkeeping requirements for pork 
or pork products used in pork-filled pasta products being exported to 
the United States. A processing facility would have to maintain under 
lock and key, for a minimum of 2 years, an original record of each lot 
of pork or pork products used for meat-filled pasta products for U.S. 
export. Each record would have to include the date that the cooked or 
dry-cured pork product was received in the processing facility; 
information on the number of packages, the number of hams or cooked 
pork products per package, and the weight of each package; a lot number 
or other identification marks; 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 the 
date that the product 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). These recordkeeping requirements would be 
consistent with those set out in Sec.  94.17 for exports of dry-cured 
pork products to the United States.
    Finally, paragraph (c)(8) would require that pork-filled pasta 
arriving in the United States be accompanied by a certificate issued by 
an official veterinarian of the National Government of the region in 
which the pasta product is processed stating that the product has been 
processed in accordance with the requirements discussed in the 
preceding paragraphs. This certificate would provide further assurance 
that the processing facilities are complying with our regulations.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed 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 proposed rule would amend 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 Italy and other 
affected regions. These proposed procedures would 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 would 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.\2\ Cash receipts from swine farming in 2001 were 
about $12.1 billion.\3\ 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 non-agricultural 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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    \2\ USDA/NASS, Quarterly Hogs and Pigs, Agricultural Statistics 
Board, March 2002.
    \3\ 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 Italy are durum wheat producers and 
pasta manufacturing companies.
    In 1997, 6,887 farms, over 99 percent of which were considered 
small,\4\ produced about 5.160 billion pounds of durum wheat.\5\ In 
2001 durum wheat production was estimated at about 5.013 billion pounds 
on 2.789 million harvested acres.\6\ 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).\7\
    As a new product, dry, shelf-stable, pork-filled tortellini is 
expected to have a small market. The impact, if any, on durum wheat 
producers 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.
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    \4\ 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.
    \5\ USDA/NASS, 1997 Census of Agriculture (for AZ, CA, MN, MT, 
ND, and SD). These are durum wheat-producing States.
    \6\ USDA/NASS, Crop Production 2001 Summary, Agricultural 
Statistics Board, January 2002.
    \7\ Global Trade Information Services, Inc., World Trade Atlas, 
United States Edition, December 2001.
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    There were 141 pasta manufacturing plants in the United States in 
2000. Of these, five companies accounted for 55 percent of the sales. 
The total domestic capacity is estimated to be about 3.4 billion pounds 
of pasta.\8\ Pasta producers are considered small businesses if they 
employ 500 workers or fewer.\9\ Most U.S. pasta manufacturers can be 
considered small.
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    \8\ Michael Boland and David Barton, ``How Dakota Growers Pasta 
co-op found success in a highly competitive market,'' July 2001 
(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.
    \9\ NAICS code 311823, dry pasta manufacturers.

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[[Page 2713]]

    Compared to total imports of pasta, valued at $324 million in 2001, 
imports of stuffed pasta make up a relatively small proportion.\10\ 
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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    \10\ 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 would be expected if 
imports were to be 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 impact 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 could 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 would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. If this proposed rule is adopted: (1) All State 
and local laws and regulations that are inconsistent with this rule 
will be preempted; (2) no retroactive effect will be given to this 
rule; and (3) administrative proceedings will not be required before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. 02-003-1. 
Please send a copy of your comments to: (1) Docket No. 02-003-1, 
Regulatory Analysis and Development, PPD, APHIS, Station 3C71, 4700 
River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance 
Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue 
SW., Washington, DC 20250. A comment to OMB is best assured of having 
its full effect if OMB receives it within 30 days of publication of 
this proposed rule.
    Under this proposed rule, a processing facility that produces pork-
filled pasta products for export to the United States would have to 
keep an original record of each lot of pork or pork products used in 
such pasta products. In addition, the pork-filled pasta would have to 
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 9 CFR 327.4, stating that the pork-filled pasta product has been 
processed in accordance with the requirements of paragraphs (c)(1) 
through (c)(5) of Sec.  94.12.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 1.25 hours per response.
    Respondents: Officials of the National Government of the region in 
which the meat-filled pasta product is processed.
    Estimated annual number of respondents: 5.
    Estimated annual number of responses per respondent: 20.
    Estimated annual number of responses: 100.
    Estimated total annual burden on respondents: 125 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    Copies of this information collection can be obtained from Mrs. 
Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 
734-7477.

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 proposed 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.

    Accordingly, we propose to amend 9 CFR part 94 as follows:

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 would continue to read as 
follows:

    Authority: 7 U.S.C. 450, 7711-7714, 7751, 7754, 8303, 8306, 
8308, 8310, 8311, and 8315; 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.

    2. In Sec.  94.12, a new paragraph (c) would be added 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

[[Page 2714]]

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) 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.
    (3) 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.
    (4) Processing lines working with pork-filled pasta products for 
export to the United States must process only pasta containing pork 
eligible for export to the United States. 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.
    (5) 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.
    (6) The processing facility must allow periodic inspections by 
inspectors from the Animal and Plant Health Inspection Service of its 
facilities, records, and operations.
    (7) 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).
    (8) 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 paragraphs (c)(1) through (c)(5) 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.

    Done in Washington, DC, this 14th day of January 2003.
Peter Fernandez,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 03-1213 Filed 1-17-03; 8:45 am]
BILLING CODE 3410-34-P