0214 Ss 20230302

SUPPORTING STATEMENT
IMPORTATION OF PORK-FILLED PASTA
OMB NO. 0579-0214
February 6, 2023
A. Justification
1. Explain the circumstances that make the collection of information necessary. Identify
any legal or administrative requirements that necessitate the collection. Attach a copy of
the appropriate section of each statute and regulation mandating or authorizing the
collection of information.
The Animal Health Protection Act (AHPA) of 2002 is the primary Federal law governing the
protection of animal health. The law gives the Secretary of Agriculture broad authority to detect,
control, or eradicate pests or diseases of livestock or poultry. The Secretary may also prohibit or
restrict import or export of any animal or related material if necessary to prevent the spread of
any livestock or poultry pest or disease. The AHPA is contained in Title X, Subtitle E, Sections
10401-18 of P.L. 107-171, May 13, 2002, the Farm Security and Rural Investment Act of 2002
[7 U.S.C. 8301 et. seq.].
The Veterinary Services (VS) division of the Animal and Plant Health Inspection Service
(APHIS), U.S. Department of Agriculture (USDA), protects the health of the U.S. livestock and
poultry populations by preventing the spread of contagious, infectious, or communicable animal
diseases (such as swine vesicular disease (SVD)) and by eradicating such diseases from the
United States when feasible. Disease prevention is the most effective method for maintaining a
healthy animal population and for enhancing the United States’ ability to compete in the world
market of animal and animal product trade.
SVD is a highly contagious disease that resists both environmental factors and common
disinfectants. SVD rarely results in mortality in infected swine and does not cause severe
production losses. However, the disease can have a major economic impact as eradication is
costly and SVD-free regions often prohibit imports of swine, pork, and pork products from
affected regions.
APHIS regulations in title 9 of the Code of Federal Regulations (CFR), Part 94, prohibit or restrict
the importation of specified animals and animal products into the United States to prevent the
introduction into the United States livestock population of certain contagious animal diseases,
including SVD. Section 94.12(c) contains specific requirements for the processing, recordkeeping,
and certification procedures for pork-filled pasta products exported to the United States from SVDaffected regions. These regulations are designed to ensure that these products are properly
processed, and that no commingling occurs with products that are ineligible to enter the United
States.
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APHIS is asking the Office of Management and Budget (OMB) to approve, for an additional
3 years, its use of these information collection activities associated with its efforts regarding
SVD.
2. Indicate how, by whom, how frequently, and for what purpose the information is to be
used. Except for a new collection, indicate the actual use the agency has made of the
information received from the current collection.
APHIS uses the following information activities associated with its efforts to prevent an SVD
incursion into the United States:
Export Certificate (Foreign Government) - 9 CFR 94.12(c)(10)
Pork-filled pasta arriving in the United States from regions affected with SVD must be
accompanied by an export certificate. An official of the national government of the pastaproducing region completes and signs the certificate. The certificate states that the product has
been handled and processed according to the requirements of 9 CFR 94.12(c). The official
records the origin of the meat used in the product, the name and location of the facility that
processed the product, and the product’s intended destination.
Collection of Information Regarding Pork Used in Pasta and Recordkeeping (Business)
9 CFR 94.12(c)(9)
Pork-filled pasta destined for the United States from a region affected with SVD must be
processed in an establishment in which an individual, authorized by the veterinary service of the
region’s national government, maintains original records (to be kept for a minimum of 2 years)
identifying the pork by the date it entered the facility (as well as the number of packages (and the
number of hams or cooked pork products per package) and the weight of each package), the lot
number or other identifying marks, the export health certificate that accompanied the pork from
the slaughter/processing facility to the meat-filled pasta processing facility; and the date the pork
began either dry-curing or cooking. These records will provide important information in any
traceback investigation that may need to be conducted by officials of the region of origin, or by
APHIS officials.
Cooperative Service Agreement (Business) - 9 CFR 94.12(c)(2)
Before receiving pork intended to be used in pork-filled pasta products destined for the United
States, the operator of the foreign processing establishment must first enter into a cooperative
service agreement with APHIS. Under this agreement, the establishment agrees to: (1) process its
pork in accordance with 9 CFR 94.12(c) or 9 CFR 94.17 (which covers dry-cured pork
products); (2) allow the unannounced entry into the establishment of APHIS representatives for
the purpose of inspecting the facilities, operations, and records of the establishment; and (3) pay
for the costs associated with these inspections.

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Storage Requirements (Business) - 9 CFR 94.12(c)(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. If in the same storage room, the pork or pork products eligible for export
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.
3. Describe whether, and to what extent, the collection of information involves the use of
automated, electronic, mechanical, or other technological collection techniques or other
forms of information technology, e.g., permitting electronic submission of responses, and
the basis for the decision for adopting this means of collection. Also describe any
consideration of using information technology to reduce burden.
The export certificate used in this importation program is completed and signed in the country of
origin. It is not a VS form, but a document issued by a foreign government. This export certificate
requires an original signature from the issuing official and must physically accompany the
shipment to the United States; therefore, it is not a candidate for electronic submission. Also, the
cooperative service agreement requires an original signature and, therefore, cannot be submitted
electronically. However, APHIS is involved with the government-wide utilization of the
International Trade Data System (ITDS) via the Automated Commercial Environment (ACE) to
improve business operations and further Agency missions. This allows respondents to submit the
data required by U.S. Customs and Border Protection and its Partner Government Agencies
(PGAs), such as APHIS, to import and export cargo through a Single Window concept. ACE
collects some information for this importation program, such as entities involved, shipment
amounts, shipment frequency, certificate numbers, and scans of certificate documents. Burden is
reduced as APHIS accepts scanned copies of certificates in ACE based on a 2021 policy change.
4. Describe efforts to identify duplication. Show specifically why any similar information
already available cannot be used or modified for use for the purpose described in item 2
above.
The information APHIS collects in connection with this program is not available from any other
source. APHIS is the only Agency responsible for preventing the introduction of foreign animal
diseases into the United States.
5. If the collection of information impacts small businesses or other small entities, describe
any methods used to minimize burden.
The information APHIS collects in connection with this program is the absolute minimum
needed to ensure that pork-filled pasta from certain regions will pose a negligible risk of
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introducing SVD into the United States. No small businesses or other small entities will be
affected by this information collection. There are no small businesses.
6. Describe the consequence to Federal program or policy activities if the collection is not
conducted or is conducted less frequently, as well as any technical or legal obstacles to
reducing burden.
If the information was collected less frequently or not collected at all, it would significantly
hinder APHIS’ ability to ensure that pork-filled pasta from certain regions poses a minimal risk
of introducing SVD into the United States. This would make a disease incursion event much
more likely, with potentially devastating effects on the U.S. pork industry.
7. Explain any special circumstances that require the collection to be conducted in a
manner inconsistent with the general information collection guidelines in 5 CFR 1320.5.
•

requiring respondents to report information to the agency more often than
quarterly;

•

requiring respondents to prepare a written response to a collection of information
in fewer than 30 days after receipt of it;

•

requiring respondents to submit more than an original and two copies of any
document;

•

requiring respondents to retain records, other than health, medical, government
contract, grant-in-aid, or tax records for more than 3 years;

•

in connection with a statistical survey, that is not designed to produce valid and
reliable results that can be generalized to the universe of study;

•

requiring the use of a statistical data classification that has not been reviewed and
approved by OMB;

•

that includes a pledge of confidentiality that is not supported by authority
established in statute or regulation, that is not supported by disclosure and data
security policies that are consistent with the pledge, or which unnecessarily
impedes sharing of data with other agencies for compatible confidential use; or

•

requiring respondents to submit proprietary trade secret, or other confidential
information unless the agency can demonstrate that it has instituted procedures to
protect the information's confidentiality to the extent permitted by law.

This information collection was conducted in a manner consistent with the guidelines established
in 5 CFR 1320.5.
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8. Describe efforts to consult with persons outside the agency to obtain their views on the
availability of data, frequency of collection, the clarity of instructions and recordkeeping,
disclosure, or reporting form, and on the data elements to be recorded, disclosed, or
reported. If applicable, provide a copy and identify the date and page number of
publication in the Federal Register of the agency's notice, soliciting comments on the
information collection prior to submission to OMB.
APHIS contacted these respondents by email and phone to discuss the information APHIS
collects to administer its pork-filled pasta import requirements. We discussed with them how we
and they obtain the necessary data and how frequently; how much data is available; the
convenience and clarity of reporting formats and other collection instruments; and the clarity of,
and necessity for, any recordkeeping requirements. The respondents stated via email or phone
that they had no concerns with any of these items and had no further recommendations.
Alessandro Guglielmini, Logistics International Specialist
Barilla G. e R. Fratelli S.p.A.
Via Mantova, 166 - 43122 Parma PR
Phone: 0039 0521 1262939
Email: [email protected]
Chiara Piancastelli, Veterinary Doctor
Food Safety and Research Office,
Consorzio del Prosciutto di Parma
Largo Calamandrei, 1/A - 43121 Parma
Phone: 0039 0521 246273
Email: [email protected]
Viktoriya Zhovner, Veterinary Doctor
Food Safety and Research Office, Consorzio del Prosciutto di Parma
Largo Calamandrei, 1/A - 43121 Parma
Phone 0039 0521 246272
Email: [email protected]
On Thursday, September 8, 2022, pages 54954 - 54955, Volume 87, No. 173, APHIS published
in the Federal Register, a 60-day notice seeking public comments on its plans to request a 3-year
renewal of this collection of information. During this time no comments from the public were
received.
9. Explain any decision to provide any payment or gift to respondents, other than
reenumeration of contractors or grantees.
This information collection activity involves no payments or gifts to respondents.
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10. Describe any assurance of confidentiality provided to respondents and the basis for the
assurance in statute, regulation, or agency policy.
No additional assurance of confidentiality is provided with this information collection. Any and
all information obtained in this collection shall not be disclosed except in accordance with
5 U.S.C. 552a.
11. Provide additional justification for any questions of a sensitive nature, such as sexual
behavior or attitudes, religious beliefs, and other matters that are commonly considered
private. This justification should include the reasons why the agency considers the
questions necessary, the specific uses to be made of the information, the explanation to be
given to persons from whom the information is requested, and any steps to be taken to
obtain their consent.
This information collection activity will ask no questions of a personal or sensitive nature.
12. Provide estimates of the hour burden of the collection of information. Indicate the
number of respondents, frequency of response, annual hour burden, and an explanation of
how the burden was estimated.
•Indicate the number of respondents, frequency of response, annual hour burden, and an
explanation of how the burden was estimated. If this request for approval covers more than
one form, provide separate hour burden estimates for each form and aggregate the hour
burdens in Item 13 of OMB Form 83-I.
See APHIS Form 71.
•Provide estimates of annualized cost to respondents for the hour burdens for collections of
information, identifying and using appropriate wage rate categories.
Respondents are officials of the national government of the region in which the pork-filled pasta
is processed and operators of pasta facilities. APHIS estimates the total annualized cost to these
respondents to be $371.35. APHIS arrived at this figure by multiplying the total burden hours (5)
by the estimated average hourly wage of the above respondents ($51.67) and then multiplying
the result ($258.35) by 1.449 to capture benefit costs.
According to DOL BLS news release USDL-22-0469, (dated 03/18/2022,
www.bls.gov/news.release/pdf/archives/ecec 03182022.htm), benefits account for 31 percent of
employee costs, and wages account for the remaining 69 percent. Mathematically, total costs
can be calculated as a function of wages, resulting in a multiplier of 1.449.
National Government Officials – $46.71 [Discussions with APHIS international contacts]
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Operators of Pasta Facility – $56.62 [http://www.bls.gov/oes//current/oes/11-3051.htm,
Industrial Production Managers].
13. Provide estimates of the total annual cost burden to respondents or recordkeepers
resulting from the collection of information, (do not include the cost of any hour burden
shown in items 12 and 14). The cost estimates should be split into two components: (a) a
total capital and start-up cost component annualized over its expected useful life; and (b) a
total operation and maintenance and purchase of services component.
There is zero annual cost burden associated with capital and start-up costs, operation and
maintenance expenditures, and purchase of services.
14. Provide estimates of annualized cost to the Federal government. Provide a description
of the method used to estimate cost and any other expense that would not have been
incurred without this collection of information.
The annualized cost to the Federal government is estimated at $197. (See APHIS Form 79.)
15. Explain the reasons for any program changes or adjustments reported in Items 13 or
14 of the OMB Form 83-1.
There is no change from the previous renewal.
16. For collections of information whose results are planned to be published, outline plans
for tabulation and publication.
APHIS has no plans to publish information it collects in connection with this program.
17. If seeking approval to not display the expiration date for OMB approval of the
information collection, explain the reasons that display would be inappropriate.
No USDA forms are used in this collection.
18. Explain each exception to the certification statement identified in the "Certification for
Paperwork Reduction Act."
APHIS can certify compliance with all provisions of the Act.
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B. Collections of Information Employing Statistical Methods
Statistical methods are not employed in this information collection activity.

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