0449 Ss 20170906

SUPPORTING STATEMENT - OMB NO. 0579-0449
IMPORTATION OF BONE-IN OVINE MEAT FROM URUGUAY
2017
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.
Disease prevention is the most effective method for maintaining a healthy animal population and
for enhancing our ability to compete globally in animal and animal product trade.
As part of this mission, the Animal and Plant Health Inspection Service (APHIS) of the United
States Department of Agriculture (USDA) regulates the importation of animals and animal
products into the United States to guard against the introduction of animal diseases not currently
present or prevalent in this country. The regulations in title 9 of the Code of Federal Regulations
(CFR) part 94 prohibit or restrict the importation of specified animals and animal products to
prevent the introduction into the United States of various animal diseases, including rinderpest
and foot-and-mouth disease (FMD).
APHIS’ animal import regulations in sections 94.1, 94.11, and 94.29 place certain restrictions on
the importation of ovine meat from Uruguay into the United States. Under these regulations,
APHIS must collect information, prepared by an authorized certified official of the Government
of Uruguay, certifying that specific conditions for importation have been met. APHIS amended 9
CFR 94.29 to expand the kind of ovine meat allowed into the United States to include bone-in
lamb.
APHIS is asking OMB to approve its use of these information collection activities to ensure that
bone-in ovine products from Uruguay pose negligible risk of introducing FMD among other
diseases into the United States.

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 will use the following information collection activities in conjunction with other
information collection activities previously approved under 0579-0040 and 0579-0372 to ensure
that bone-in ovine products from Uruguay pose negligible risk of introducing exotic animal
disease into the United States.
9 CFR 94.22 - Foreign meat inspection certificate (Foreign Federal Government)
Imported ovine meat from Uruguay must be accompanied by a foreign meat inspection
certificate that is completed and signed by an authorized veterinary official of the Government of
Uruguay.
The certificate must verify:
• The meat is ovine meat from animals that have been born, raised, and slaughtered in
Uruguay.
• The meat comes from sheep maintained in a program approved by the APHIS
Administrator, meeting the following requirements:
o The meat comes from sheep that were moved directly from the premises of origin to
the slaughtering establishment without any contact with other animals.
o The meat comes from sheep that received FMD testing and ante-mortem and postmortem veterinary inspections, paying particular attention to the head and feet, at the
slaughtering establishment, with no evidence found of vesicular disease.
o The meat consists only of ovine parts that are, by standard practice, part of the
animal’s carcass that is placed in a chiller for maturation after slaughter. The ovine
parts that may not be imported include all parts of the head, feet, hump, hooves, and
internal organs.
o All bone and visually identifiable blood clots and lymphoid tissue have been removed
from the meat.
o The meat has not been in contact with meat from regions other than those listed in
§94.1(a)(2).
o The meat comes from carcasses that were allowed to maturate at 40 to 50 °F (4 to 10
°C) for a minimum of 24 hours after slaughter and that reached a pH of below 6.0 in
the loin muscle at the end of the maturation period. Measurements for pH must be
taken at the middle of both longissimus dorsi muscles. Any carcass in which the pH
does not reach less than 6.0 may be allowed to maturate an additional 24 hours and be
retested, and, if the carcass still has not reached a pH of less than 6.0 after 48 hours,
the meat from the carcass may not be exported to the United States.
9 CFR 94.29 - Animal Identification (Business)
Official, unique identification tags (visual tag in the left ear and RFID tag in the right ear) are
applied to all select lambs before entry into the select lamb facility. The identification number of
each lamb is verified at multiple steps within the select lamb program. The tags, in conjunction
with information captured in Uruguay’s National Livestock Information System, provide for
traceability of lambs and ensure their health status from their place of birth to slaughter.
Applying individual identification tags to the select lambs and requiring identification of select
lambs with uniquely numbered ear tags helps provide assurance that only FMD test-negative
lambs are ultimately exempted from the deboning requirement. The unique identification number

of the select lambs is linked to their individual FMD test status, allowing verification of each
animal’s health status.
9 CFR 94.29 - Testing of Select Lambs (Business)
Individual testing of select lambs for antibodies to FMD virus is done before movement off the
source farm. Producers work with veterinarians with the local animal health division of
Uruguay’s national Directorate of Livestock Services to facilitate blood sample collection from
select lambs at the source farm and record data into the Uruguay National Livestock Information
System. Samples are sent to the central laboratory of the Veterinary Laboratories Division of the
Directorate for FMD testing. If all tests of select lambs in the source flock are negative, the
lambs would move to the select lamb facility. If any animal were to test positive to the screening
test, the group of lambs would be held while follow-up testing is conducted. If these test results
are negative, the remaining lambs would be released to the select lamb facility; however, lambs
that tested positive would not be allowed to move to the facility. If the follow-up test is positive,
then movement restrictions will be placed on the source farm while an investigation is conducted
to determine if evidence of FMD virus circulation exists. Test results are reported within
approximately 1 day of submission. Movement must occur within 7 days after testing and
verified by an authorized veterinary official of the government of Uruguay on the Foreign Meat
Inspection Certificate (listed above).

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.
For trade partners who have fully automated systems, we will be accepting computer extracts of
electronic health certification health certification data. These certificates are included in the
governmentwide utilization of the International Trade Data System (ITDS) via the Automated
Commercial Environment (ACE) to improve business operations and further Agency missions.
The Foreign Meat Inspection certificate employed in this program must physically accompany
the shipment, and requires an original signature from the authorizing veterinarian to be valid;
therefore, it is not a candidate for electronic transmission.
Identification tags also accompany/are attached to the animals in the shipment, and are thus not
candidates for electronic transmission.
Testing information must accompany the animal and specimens, as well, not making it a
candidate for electronic submission.

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 exotic 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 is the absolute minimum needed to effectively evaluate the
FMD and other disease risk associated with ovine product imports from Uruguay. The
veterinarians who complete the required information and the producers who affix the required
identification are considered foreign entities and thus are not “small entities” for purposes of
Executive Order 12866 or the Regulatory Flexibility Act.

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, APHIS would be unable to
establish an effective defense against the entry and spread of exotic animal diseases from
Uruguay ovine product imports. This would cause serious health consequences for U.S. livestock
and economic consequences for the U.S. livestock 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;
Select lamb test results are reported within approximately 1 day of submission and
movement must occur within 7 days after testing.

•

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.

No other special circumstances exist that would require this information collection to be
conducted in a manner inconsistent with the general information collection guidelines in 5 CFR
1320.5.

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 spoke to the following individuals concerning the information collection activities
associated with this program:
Rick Smaligo
Sampco, Inc.
651 W. Washington Boulevard
Suite 300
Chicago, Illinois 60661
(312) 346-1506
Laurie Hueneke, International Trade Specialist
122 C Street, N.W., Suite 875
Washington, DC 20001
202-347-3600
Robert L. Morris, Jr.
International LLC
8417 Amparan, El Portal Industrial Park
Laredo, TX 78045-1829
956-723-6492
nnorris@morrisintl.Jlc.com
The proposed rule, Docket Number APHIS-2015-0050, was published in the Federal Register on
July 1, 2016, with a 60-day comment period. During this time, 17 comments were received by
interested members of the public, which included producers, importers, exporters, industry and
professional associations, specialty food retailers, and representatives of local and foreign

governments. Ten commenters were generally supportive of the proposed rule. Four commenters
were opposed to the proposed rule but did not address specific provisions. The remaining
commenters raised questions or concerns about the proposed rule and the risk analysis.
There were no changes made to the proposed rule in response to the comments and it is being
adopted as a final rule, without change.

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.

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. However,
the confidentiality of information is protected under 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. Burden estimates were developed from discussions with Uruguay Federal
animal health authorities.
• Provide estimates of annualized cost to respondents for the hour burdens for collections
of information, identifying and using appropriate wage rate categories.

Respondents are authorized veterinary officials employed by the Government of Uruguay and
producers in Uruguay. APHIS estimates the total annualized cost to these respondents to be
$162,162. APHIS arrived at this figure by multiplying the total burden hours (9,009 hours) by
the estimated average hourly wage of the above respondents ($18).
The hourly rate was determined through discussions with International contacts based in
Uruguay.

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.
No annual cost burden is associated with capital and startup 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 $215, 661. (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.
•

Annual
Number of
Responses
Annual Time
Burden (Hr)
Annual Cost
Burden ($)

Program Program
Change
Change
Change
Change
Due to
Due to
Previously
Requested Due to
Due to Adjustment Potential
Approved
New
Agency in Agency Violation
Statute Discretion Estimate of the PRA
18,006
0
18,006
0
0
0

9,009

0

9,009

0

0

0

0

0

0

0

0

0

This is a new information collection resulting in 9,009 total burden hours.

16. For collections of information whose results are planned to be published, outline plans
for tabulation and publication.
APHIS has no plans to publish the 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.
NA. There are no Agency forms included in this information collection.

18. Explain each exception to the certification statement identified in the "Certification for
Paperwork Reduction Act."
APHIS can certify compliance with all provisions in the Act.

B. Collections of Information Employing Statistical Methods
Statistical methods are not employed in this information collection activity.