0579-0212 2017 Ss

September 2017
SUPPORTING STATEMENT
BLOOD AND TISSUE COLLECTION, AND RECORDKEEPING, AT SLAUGHTERING,
RENDERING, AND APPROVED LIVESTOCK MARKETING ESTABLISHMENTS AND
FACILITIES
OMB NO. 0579-0212
NOTE: This information collection merges two currently approved information collections,
OMB control number 0579-0212, “Blood and Tissue Collection at Slaughtering and Rendering
Establishments”, and 0579-0258, “Interstate Movement of Sheep and Goats; Recordkeeping for
Approved Livestock Marketing Facilities and Slaughtering and Rendering Establishments”. After
OMB approves this combined information collection package (0579-0212), APHIS will retire OMB
Control Number 0579-0258. Also, as a result of the aforementioned merging of information
collection packages, APHIS revised the name of this information collection to “Blood and Tissue
Collection, and Recordkeeping, at Slaughtering, Rendering, and Approved Livestock Marketing
Establishments and Facilities”.
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 U.S. Department of Agriculture (USDA) is authorized to prevent the interstate spread of livestock
diseases and for eradicating such diseases from the United States when feasible under the Animal Health
Protection Act (Title X, Subtitle E, Sections 10401-18 of P.L. 107-171, May 13, 2002, the Farm Security
and Rural Investment Act of 2002). Under 7 U.S.C. 8301, the USDA, Animal and Plant Health Inspection
Service (APHIS), conducts this prevention and eradication mission, and APHIS’ Veterinary Services
(VS) program conducts animal disease surveillance and testing using procedures and agreements
prescribed in Title 9, Code of Federal Regulations, Part 71.
Disease prevention is the most effective method for maintaining a healthy animal population and for
enhancing the United States’ ability to compete in international animal and animal product trade markets.
A key element of this approach is the restricted interstate movement of livestock within the United States
to mitigate the spread of diseases, allowing APHIS to use livestock movement records to conduct disease
surveillance for protecting the health of livestock and poultry populations. Epidemiological data from
blood and tissue sampling is used to assess the prevalence of disease and to identify its source. Coupled
with animal identification, blood and tissue test results are used to trace the movement of an animal that
tests positive, and identify other animals it may have come into contact with that may also be diseased.
When a disease is suspected in a given area, sampling is used to determine its presence or absence and to
estimate the incidence or prevalence if it is present. The amount of sampling may increase in selected
areas when a disease outbreak is suspected, then reduced in that area when sufficient tests have been done
to prove the suspicion was unfounded or, if found, after the disease is eradicated. Sampling is also used to
provide data for new or updated risk analyses in support of disease control programs, and, as required,
opening international markets for animal products.
Regulations 9 CFR 71.20 and 71.21 authorize APHIS to conduct disease surveillance and blood and
tissue sampling activities using mandatory Livestock Facility Agreements and Listing Agreements
between APHIS and owners and operators of slaughtering and rendering establishments and livestock
1

marketing facilities. APHIS requires all livestock facilities to enter Approval of Livestock Facilities
Agreements which require animal identification, timely notifications, recordkeeping, and other actions
that facilitate tracking animal movements and identifying possible disease occurrences. APHIS requires
all slaughtering and rendering establishments to enter Listing Agreements which permit the Agency to
conduct blood and tissue sampling at the facilities. The Agreements are critical during disease outbreaks
as they reduce delays in assessments and, subsequently, disease spread.
APHIS is asking OMB to approve, for an additional 3 years, its use of these information collection
activities in connection with its program to collect from animals blood and tissue samples, and trace their
movements, as they move through slaughtering and rendering establishments, and livestock marketing
facilities.

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 collection activities to approve and monitor the interstate
movement of livestock as it pertains to disease control, and perform testing at slaughtering and rendering
establishments to mitigate the spread of animal disease within the United States:
Agreement - Approved Livestock Facility for Handling Livestock Pursuant to Title 9 of the Code of
Federal Records; (9 CFR 71.20(a)) (State)(Business) (0579-0258) - (hereon called Agreement.) To
obtain APHIS approval for handling animals in interstate commerce, the individual legally responsible for
the day-to-day operation of a livestock facility must execute an approved livestock facility agreement
with APHIS. The agreement allows VS to identify livestock movement nexus points for efficient
livestock testing and monitoring for potential diseases. Agreements are completed for new markets and
changes in existing livestock market facilities. VS officials prepare the document after obtaining from the
facility owner or operator the name of the facility, its address, and a business telephone number. The
owner or operator then indicates, by initialing the appropriate paragraphs of the agreement, the class or
classes of livestock that will be handled at the facility. The owner or operator must sign the document
agreeing to follow its requirements. APHIS also requires the State animal health official to sign the
Agreement. The facility and State are provided copies with the original maintained at the Regional VS
Field Office.
Schedule of Sales Days; (9 CFR 71.20(a)) (Business) (New) - Each Agreement requires the facility to
provide timely schedules of sales days which indicate the types of animals that will be handled at the
facility. The schedules allow accredited veterinarians, State representatives, and/or APHIS representatives
to be on site to perform testing and monitoring. Schedules are usually included in the Agreement.
Diseased Animal Notification; (9 CFR 71.20(a)) (Business) (New) - Each Agreement requires facilities,
or State representatives or accredited veterinarians if they are on site, to immediately notify APHIS when
any livestock arrives and is known to be infected, exposed, high risk and scrapie-positive or suspect, or
that shows signs of possibly being infected with any infectious, contagious, or communicable disease.
Notification allows APHIS representatives to perform testing and monitoring in a timely manner.
Quarantine Signs; (9 CFR 71.20(a)) (Business) (Third Party Disclosure) (New) - Agreements require
quarantine pens to be posted with quarantine signs alerting people of the presence of potentially infected
animals.

2

Request for Appeal of Denial of Agreement; (9 CFR 71.20(b)(1)) (Business) (New) - If APHIS denies
an Agreement, the owner or operator of the establishment may appeal the denial in writing within 10 days
after receiving notification. The appeal must include all of the facts and reasons on which the owner or
operator relies to show that the establishment was wrongfully denied the Agreement. The Administrator
will grant or deny the appeal, in writing, as promptly as circumstances permit, stating the reason for its
decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. The
owner or operator must send the request for appeal directly to APHIS.
Request for Appeal of Withdrawal of Agreement; (9 CFR 71.20(b)(2)) (Business) (New) - If APHIS
withdraws an Agreement, the owner or operator of the establishment may appeal the withdrawal in
writing within 10 days after receiving notification. The appeal must include all of the facts and reasons on
which the owner or operator relies to show that the establishment was wrongfully denied the Agreement.
The Administrator will grant or deny the appeal, in writing and as promptly as circumstances permit,
stating the reason for its decision. If there is a conflict as to any material fact, a hearing will be held to
resolve the conflict. The owner or operator must send the request for appeal directly to APHIS.
Withdrawal of a Livestock Facility Agreement; (9 CFR 71.20(b)(3)) (Business) - The Administrator
will automatically withdraw the approval of an establishment to handle livestock for blood and tissue
collection if the operator of the establishment notifies the Administrator, in writing, that the establishment
no longer handles livestock moved interstate, or that the person who signed the Agreement is no longer
responsible for the day-to-day operations of the establishment.
Listing Agreement for a Slaughter or Rendering Establishment Handling Livestock, Poultry, or
Carcasses in Interstate Commerce Pursuant to Title 9, Code of Federal Regulations
(VS Forms 10-6A and 6B); (9 CFR 71.21(a)) (Business) (0579-0258) - APHIS surveillance programs
characterize program diseases, track known disease problems, identify new and emerging disease
problems for which Federal and State programs do not exist, and document disease freedom status for
exotic diseases that do not exist in the United States. Meeting APHIS-wide animal disease surveillance
goals requires the collection of blood and tissue samples at slaughter at different times, and under
different circumstances. To accommodate these activities, APHIS requires slaughtering or rendering
facilities to enter into a Listing Agreement with APHIS. Agreements are completed for new plants or
when they have significant changes in operations. Through the Agreements, plants authorize APHIS to
collect blood and tissue samples on their premises without cost to the United States, and allow VS or its
representatives to record all internal and external animal identification devices for animals from which
blood and tissue samples are collected. The Agreement contains the name, address, and telephone number
of the facility and lists the type of animal carcasses handled at the facility. After authorized business
representatives sign and date the Agreement, copies are provided and the original maintained at the VS
Field Office.
USDA Listed Slaughter or Rendering Facility Inspection Report (VS Form 10-5);
(9 CFR 71.21(b)) (Business) - The Administrator will list a slaughtering or rendering establishment after
determining it meets the facility and access requirements of 9 CFR 71.21(b). Determination is made by
inspection using VS Form 10-5 (USDA Listed Slaughter or Rendering Facility Inspection Report) that
includes basic contact and production information provided by the facility. A copy of the results is
provided to the facility once signed by a VS official; the original is maintained at the VS Area Office.
Request for Appeal of Denial of Listing; (9 CFR 71.21(d)(1)) (Business) - If APHIS denies the listing
of an establishment, the owner or operator of the establishment may appeal the denial in writing within 10
days after receiving notification. The appeal must include all of the facts and reasons on which the owner
or operator relies to show that the establishment was wrongfully denied listing. The Administrator will
grant or deny the appeal, in writing, as promptly as circumstances permit, stating the reason for his or her
3

decision. If there is a conflict as to any material fact, a hearing will be held to resolve the conflict. The
owner or operator must send the request for appeal directly to APHIS.
Request for Appeal of Withdrawal of Listing; (9 CFR 71.21(d)(2)) (Business) - If APHIS withdraws
listing approval from an establishment, the establishment owner or operator may appeal the withdrawal in
writing within 10 days after receiving notification. The appeal must include all of the facts and reasons on
which the owner or operator relies to show that the reasons for the proposed withdrawal are incorrect or
do not support the withdrawal of the listing. The Administrator will grant or deny the appeal, in writing,
as promptly as circumstances permit, stating the reason for his or her decision. If there is a conflict as to
any material fact, a hearing will be held to resolve the conflict. The owner or operator must send the
request for appeal directly to APHIS.
Recordkeeping; (9 CFR 71.20(a)) (General; 2-Year Requirement; 5-Year Requirement) (Business)
(0579-0258) - Approved livestock marketing facilities are required to maintain records that trace the
movement of livestock. Records include weight tickets, sales slips, and records of origin, identification,
and destination that related to livestock that are in, or that have been in, the facility. For poultry and
swine, such documents must be kept for at least 2 years, and for cattle and bison, sheep and goats, cervids,
and equines, for at least 5 years. These retention periods allow APHIS to trace the movements of diseased
livestock or poultry farther into the past than current records allow and facilitates finding potentially
infected or exposed livestock or poultry that might otherwise remain unidentified.

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.
Approved Livestock Facility Agreements, and Listing Agreements for a Slaughter or Rendering
Establishment (VS Forms 10-6A and VS Forms 10-6B), may be prepared electronically but they require
original signatures to be valid. Electronic submission is not practical at this time.
VS Form 10-5 (Facility Inspection Report) is completed by VS personnel. A copy of the report becomes
part of the Listing Agreement.
Appeals and requests for withdrawal may be submitted to VS in any format but the documents must have
original signatures to be valid.
Changes to schedules of sales days may be provided to VS by facility representatives in any format
suitable to both parties. This includes telephone call or email.
Notifying officials of suspected diseased animals may be done via telephone call or email.
Quarantine signs must be physically affixed to the holding pens containing suspected diseased animals.
The medium for storing livestock records is at the discretion of facility owners. At a minimum, the
following information must be maintained and made available when requested by VS: name and address
of the individual from whom an animal was purchased; the animal’s sex, year of birth, and breed; date the
animal entered the facility; and the animal’s final disposition. Facilities are encouraged to store this
information electronically when possible.

4

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.
APHIS is the only Federal agency responsible for detecting and controlling contagious animal diseases in
the United States. The information that APHIS collects is not available from any other source.

5. If the collection of information impacts small businesses or other small entities, describe any
methods used to minimize burden.
Approximately 98 percent of the business respondents are small entities. The information APHIS collects
is the minimum needed to conduct its test-at-slaughter surveillance program and implement its animal
disease surveillance program. Most of the non-recordkeeping paperwork in this information collection is
prepared by VS personnel for respondent signature or is infrequently required.

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.
Collecting this information less frequently or failing to require recordkeeping would make it impossible
for APHIS to effectively operate its disease surveillance programs. The agency’s ability to detect disease
in the United States animal population, prevent disease spread within the country, and ultimately
eliminate certain animal diseases from the United States, would be severely hampered. Failure to detect
and eliminate a contagious livestock disease before it is transmitted to another herd or flock may result in
multimillion dollar economic losses for meat producers, and impact the supply and prices of meats for
United States consumers.

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;
As part of its agreement with USDA, livestock facilities are required to provide APHIS
representatives schedules and notices of sale days, and to report receipt of suspected diseased animals
when they are discovered. Notices from the same facility may occur days or weeks apart.

•

requiring respondents to prepare a written response to a collection of information in fewer than
30 days after receipt of it;
If APHIS denies or withdraws an Approved Facility Agreement or a Listing Agreement, the
establishment owner or operator may appeal the action in writing within 10 days after receiving
notification.

•

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

•

requiring respondents to retain records, other than health, medical, governmental contract,
grant-in-aid, or tax records for more than 3 years;
Animal diseases are traced to transmitting animals using certain livestock records. Some diseases,
such as scrapie in sheep, have long incubation periods and may not appear in a live animal until 5
5

years or more after exposure. Therefore, to facilitate traces when they are needed, certain livestock
records must be accessible for a minimum of 5 years after the death of an animal or the departure of
an animal from a livestock facility.
•

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 statue
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 consulted with the following individuals regarding this information collection:
Dennis Metzger
Chair, Livestock Marketing Council
National Cattlemen’s Beef Association
1275 Pennsylvania Avenue NW, Suite 801
Washington, DC 20004
Phone: 202-347-0228
Mark Miller
Cargill Meat Solutions, LLC
1252 Route 706
Wyalusing, PA 18853
Phone: 570-746-3000
Jessica Meisinger, PhD
Director, Scientific Education and Communication
National Renderers Association
500 Montgomery Street, Suite 310
Alexandria, VA 22314
Phone: 703-683-2914

6

On Friday, July 14, 2017, APHIS published in the Federal Register on pages 32529 and 32530 a
60-day notice seeking public comments on its plans to request a 3-year renewal of this collection of
information. No comments from the public were received.

9. Explain any decision to provide any payment or gift to respondents, other than remuneration 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 asks 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.
APHIS estimates the total annualized cost to respondents to be $97,110.30. Respondents are: (1) State
animal health officials, (2) accredited veterinarians, and (3) livestock marketing, slaughtering, and
rendering establishment owners and employees. APHIS arrived at this cost figure by multiplying the
respondents’ $39.30 estimated average hourly wage by the 2,471 burden hours in this information
collection.
The average hourly wage was derived from U.S. Department of Labor Bureau of Labor Statistics website
at https://www.bls.gov/news.release/pdf/ocwage.pdf. Wages used are for State animal health authorities
[11-0000 Management Occupations] ($55.30); veterinarians ($47.59); agricultural inspectors ($21.06);

7

owners or operators of livestock facilities [General and Operations Managers] ($57.44); and
miscellaneous production workers [Production Workers, All Others] ($15.15).

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.
See APHIS Form 79. The estimated annualized cost to the Federal Government is $258,752.42.

15. Explain the reasons for any program changes or adjustments reported in Items 13 or 14 of the
OMB Form 83-1.

Requested
Annual Number of
Responses
Annual Time
Burden (Hours)

Program
Change Due to Change Due to
Program
Change Due to Adjustment in
Potential
Change Due to
Agency
Agency
Violation of the
New Statute
Discretion
Estimate
PRA

Previously
Approved

14,010

0

4,382

0

0

9,628

2,471

0

866

0

0

1,605

In this renewal, the number of respondents increased from 1,925 to 2,818. The number of annual
responses increased from 9,628 to 14,010 (for a net increase of 4,382 responses), and the total burden
hours increased from 1,605 to 2,471 (for a net increase of 866 hours).
The merger of 0579-0258 into this information collection request added Approval of Livestock Facility
Agreements, additional Listing Agreement forms (now VS Forms 10-6A and 10-6B), and three
recordkeeping requirements. Also contributing to the increases are the addition of five burdens that are
potentially in violation of the Paperwork Reduction Act. Previously unreported, the activities include
reporting adjusted Schedules of Sales Days, Diseased Animal Notifications, placing Quarantine Signs,
and Requests for Appeal of agreement denial or withdrawal. These potential violations comprise a total
13 responses and 6 hours of burden.
[see next page for a breakdown of all changes]

8

CHANGES IN RESPONSES
9 CFR
71.20(a)
71.20(a)
71.20(a)
71.20(a)
71.20(a)
71.20(b1)
71.20(b2)
71.21(a)
71.20(a)

REASON
Live Facility Agreement
Live Facility Agreement
Schedules of Sales Days
Animal Disease Notice
Quarantine Signs
Appeal, Deny Agreement
Appeal, Withdraw Agree
Listing Agreement
Recordkeeping

RESP
Bus
Gov’t
Bus
Bus
Bus
Bus
Bus
Bus
Bus

PREVIOUS
NEW
RESPONSES RESPONSES
0
138
0
138
0
2
0
2
0
7
0
1
0
1
1,925
2,675
0
3,343
1,925
6,307

DIFFERENCE
138
138
2
2
7
1
1
750
3,343
+ 4,382

TYPE OF CHANGE
DISCRETION - merger
DISCRETION - merger
DISCRETION - new
DISCRETION - new
DISCRETION - new
DISCRETION - new
DISCRETION - new
DISCRETION - merger
DISCRETION - merger

DIFFERENCE
138
23
1
1
2
1
1
375
324
+ 866

TYPE OF CHANGE
DISCRETION - merger
DISCRETION - merger
DISCRETION - new
DISCRETION - new
DISCRETION - new
DISCRETION - new
DISCRETION - new
DISCRETION - merger
DISCRETION - merger

CHANGES IN BURDEN HOURS
9 CFR
71.20(a)
71.20(a)
71.20(a)
71.20(a)
71.20(a)
71.20(b1)
71.20(b2)
71.21(a)
71.20(a)

REASON
Live Facility Agreement
Live Facility Agreement
Schedules of Sales Days
Animal Disease Notice
Quarantine Signs
Appeal, Deny Agreement
Appeal, Withdraw Agree
Listing Agreement
Recordkeeping

RESP
Bus
Gov’t
Bus
Bus
Bus
Bus
Bus
Bus
Bus

PREVIOUS
BURDEN
0
0
0
0
0
0
0
963
0
963

NEW
BURDEN
138
23
1
1
2
1
1
1,338
324
1,829

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.
APHIS will display expiration dates on VS Forms 10-5, 10-6A, and 10-6B. No other USDA forms are
currently used in this information collection.

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

B. Collections of Information Employing Statistical Methods
There are no statistical methods associated with the information collection activities used in this program.

9