[Federal Register: January 21, 2003 (Volume 68, Number 13)]
[Proposed Rules]
[Page 2711-2714]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21ja03-18]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 regulations@aphis.usda.gov. 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
[[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.
---------------------------------------------------------------------------
\10\ Global Trade Information Services, Inc., World Trade Atlas,
United States Edition, December 2001.
---------------------------------------------------------------------------
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