Lab Approval SS 20190530

SUPPORTING STATEMENT
Approval of Laboratories to
Conduct Official Testing; Consolidation of Regulations
OMB-0579-XXXX

May 2019

A. Justification
1. Explain the circumstances that make the collection of information necessary.
Identify any legal or administrative requirements that necessitate the collection.
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 enhancing the ability of U.S. producers to compete in the global market of
animal and animal product trade.
The regulations of the Animal and Plant Health Inspection Service (APHIS) require
APHIS approval or certification for laboratories conducting tests for disease management
as well as live animal interstate movement, import and export. APHIS is proposing to
consolidate these regulations and establish a set of standard procedures by which APHIS
could conduct all future diagnostic laboratory approvals. The consolidated regulations
would provide consistent inspection protocols, proficiency testing methods, quality
system guidelines, and definitions. This would also facilitate the approval of additional
laboratories in emergency situations. The consolidated regulations would serve to
simplify regulatory oversight and compliance.
APHIS is asking OMB to approve, for 3 years, of APHIS’ use of the associated
information collection activities.
2. Indicate how, by whom, 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 activities to approve laboratories to conduct
official animal disease testing.

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Notification for Intent to Request Approval (Private Sector) (State, Local, and
Tribal Government) – 9 CFR 71.22(a)
The laboratory must inform APHIS via telephone or email of its intent to request
approval. This initial contact notifies the APHIS Veterinary Services (VS) that the
laboratory is initiating the process. This is necessary because there are two components to
acquiring APHIS approval — VS’ evaluation of the technical information/proficiency
testing results and the laboratory site inspection (see below).
Application for APHIS Approval (Private Sector) (State, Local, and Tribal
Government) – 9 CFR 71.22(a), (g)
Laboratories requesting approval to conduct official testing must also submit an application
package to VS. APHIS is preparing a form/worksheet to use for this process which will be
included in the final information collection package. The application must contain:
• The laboratory’s name, physical location, and mailing address.
• The names of the legally responsible official and the laboratory director.
• A description of the laboratory facilities and equipment used in performing tests.
• A list of specific diagnostic assays for which the laboratory has requested approval.
• Test protocols.
• A list of individuals performing the tests, including their names, professions, and
technical qualifications.
• A statement confirming that the laboratory has met proper storage conditions.
• The testing agreement (see below for agreement description)
Any previously approved laboratories that wish to maintain their approved status would be
required to reapply for APHIS approval at least 1 month before their approval term expires,
or at least every 2 years, whichever comes first. APHIS is preparing a form/worksheet to
use for this renewal process which will be included in the final rule information collection
package.
Laboratories would also have to submit applicable portions of the application materials if
APHIS suspends approval to conduct testing. Reasons for suspension include changes that
affect the laboratory’s ability to provide quality testing services, such as no longer
employing an individual approved to conduct official testing, a move to different facilities,
or a natural disaster that impacts power or water systems.
Inspection (Private Sector) (State, Local, and Tribal Government) – 9 CFR 71.22(b)
APHIS will approve laboratories to conduct official testing only after the physical
facilities have passed an inspection conducted by an APHIS representative and after VS
has consulted with the State animal health official in the State in which the laboratory or
diagnostic facility is located and has determined that the laboratory applicant:
• Has technical personnel assigned to conduct official testing who have successfully
completed VS’ National Veterinary Services Laboratories (NVSL) training. (APHIS
employees conduct this training).
• Uses U.S. Department of Agriculture licensed test materials as appropriate.
• Follows standard NVSL test protocols.
• Meets NVSL check test proficiency requirements.
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•
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Refers samples to NVSL for confirmation as appropriate.
The laboratory provides the State animal health official and the AVIC with timely
reports of any positive test results.
Maintains an annual test minimum as appropriate.
Accepts samples only from a USDA Category II accredited veterinarian and with
approval to conduct accredited activities in the State in which the sample was drawn.
Accepts submissions only with approved, properly and completely filled, test forms.
Accepts submissions only on animals properly identified (microchips, drawings,
photographs, breed registration number, etc.).

APHIS will inspect the laboratory premises, equipment, and functions. The laboratory
director (or his or her representative present at the time of inspection) must provide his or
her contact information as well as that of the laboratory in general; the names of
employees trained and authorized by APHIS to conduct tests and the dates of their
authorization.
Checklist and Agreement – (Private Sector) (State, Local, and Tribal Government) 9 CFR 71.22(b)-(f)
APHIS is preparing checklist and agreement forms/documents to evaluate laboratories
during the inspection and while evaluating the application materials. The checklist
documents also evaluate the applicant’s quality system and accreditation status. The
new/proposed checklist and agreement forms/documents will be used for the following
purposes:
1) In the agreement, laboratory applicants must provide the laboratory name and
address as well as contact information for all facilities (branch or system
laboratories) to be involved with testing. Applicants must also specify the
proposed participating surveillance programs and the associated testing. The
agreement also asks the laboratory to list the assays it can perform for recognized
program and foreign animal diseases; and to aver: That it can document
implementation of a quality system (see further below); that it will abide by
APHIS testing and reporting procedures, or will seek permission for a deviation if
necessary; that its personnel will not use test material for research, distribute any
materials outside of the laboratory, and comply with select agent regulations; that
it will accept and test samples in support of disease investigations and outbreak
situations, if it has the approval, capability, and capacity to assist in testing
samples; and that it can and will track and report disease adequately.
2) Applicants must sign and date the checklist. They must also get signatures from
applicable State authorities if needed. The Area Veterinarian in Charge must also
sign the form.
3) VS staff record the date they receive each completed checklist. Staff reviews and
verifies the information from each completed checklist:
• The State and name of the laboratory, and the name of the Laboratory
Director.
• The date the packet was received.
• Completeness of the checklists and the required signatures.
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Listed branch or system laboratories.
The surveillance programs for which the laboratory, including branch or
system laboratories, seeks approval.
• The surveillance programs that the laboratory no longer wishes to participate
in.
4) Checklists are approved if they:
• Have been completed appropriately.
• Contain the required signatures.
• Contain any necessary supplemental documentation and show sufficient
evidence of an implemented quality system.
5) Laboratories must agree to regular site visits and successfully show use of a
quality system.
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•

Documentation of Accreditation Status – (Private Sector) (State, Local, and Tribal
Government) – 9 CFR 71.22(d)
Accredited laboratories must provide proof of accreditation status, such as a certificate
from the American Association of Veterinary Laboratory Diagnosticians or from a body
authorized to grant accreditation acceptable to the World Organization for Animal Health
(OIE) under ISO 17025. Accreditation can be granted for 1 to 5 years. The applicant need
only submit proof of accreditation once during the accreditation period. APHIS animal
health program staff record the source of accreditation and the certificate expiration date.
Documentation of Implemented Quality System – (Private Sector) (State, Local, and
Tribal Government) – 9 CFR 71.22(c)
Applicants must document implementation of a quality management system. Quality
systems may be comprised of elements such as documentation of procedures,
recordkeeping, training, reporting, and corrective actions taken if standards and
procedures are not reached or maintained. Required documentation includes the
laboratory’s Quality Manual and System Standard Operating Procedures (SOPs). A new
applicant must provide all available documents, while a laboratory applying to continue
participation need only submit any document modified since the previous submission.
APHIS staff reviews the documents to assess a laboratory’s quality system.
Quality Document Verification Form – (Private Sector) (State, Local, and Tribal
Government) – 9 CFR 71.22(c)
APHIS is preparing a form/documents to summarize the requested quality documentation
within the applicant laboratory’s quality system. It must be verified by the laboratory
director before submission to APHIS. The laboratory director identifies current and
revised documents and provides updated versions.
Quality Assurance/Control Plans - (Private Sector) (State, Local, and Tribal
Government) – 9 CFR 71.22(c)
Laboratories produce and maintain appropriate quality assurance and quality control
plans. To obtain APHIS approval for certification, laboratories must give APHIS a copy
of these plans.
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Recordkeeping of Quality Assurance/Control Plans - (Private Sector) (State, Local,
and Tribal Government) -9 CFR 71.22(c)
Laboratories must maintain copies of their quality control and assurance plans for 5
years. Recordkeeping is critical to ensure swift and accurate animal health investigations.
Notification of Proposed Changes to Assay Protocols - (Private Sector) (State, Local,
and Tribal Government) – 9 CFR 71.22(h)
Laboratories must conduct testing using APHIS-approved assay methods and submit to
APHIS, in advance and in writing, any proposed changes to assay protocols..
Laboratories that generate results based on modified protocols that have not received
written approval risk losing approval status. Consequently, APHIS must approve any
proposed changes before the laboratory incorporates those changes. Without APHIS’
prior approval, APHIS would be unable to determine if the Agency can endorse the test
results.
Recordkeeping: Supporting Assay Documentation (Private Sector) (State, Local,
and Tribal Government) – 9 CFR 71.22(h)
To verify a laboratory’s compliance with APHIS-approved protocols, which are in
accordance with OIE recommendations, APHIS may request supporting pathogen
detection and identification assay documentation for test results that support specific
export health certification endorsed through the appropriate VS Field Operations Office.
The laboratory should keep this documentation for 5 years.
Reporting – (Private Sector) (State, Local, and Tribal Government) – 9 CFR
71.22(f)
Approved laboratories must report test results to APHIS and State animal health officials
using an individualized timeline established by APHIS at the time of laboratory approval.
Laboratories would have to submit test results in periods ranging from 24 hours to 30
days depending on the type test and the disease in question Approved laboratories must
also report any changes that affect their approved status, such as no longer employing an
individual approved to conduct official testing, a move to different facilities, or a natural
disaster that impacts power or water systems.
Test Exemption - (Private Sector) (State, Local, and Tribal Government) - 9 CFR
71.22(g)
Laboratories not conducting the minimum number of tests as required in 9 CFR
71.22(g)(3) during a single reporting period would be assigned probationary status. A
reporting period would be less than or equal to the time for which the laboratory has been
approved to conduct testing by APHIS. Laboratories under probation could continue to
conduct official testing. If the minimum number of tests are not performed during two
consecutive reporting periods, the laboratory would not be eligible for renewal of APHIS
approval. Exceptions to this requirement may be granted by APHIS on request.

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Submission of Sample Copies of Diagnostic Reports - (Private Sector) (State, Local,
and Tribal Government) – 9 CFR 71.22(f)
Laboratories produce diagnostic reports. To obtain APHIS approval for certification,
laboratories must give APHIS a copy of these reports.
Recordkeeping of Sample Copies of Diagnostic Reports - (Private Sector) (State,
Local, and Tribal Government) – 9 CFR 71.22(f)
Laboratories must maintain records of the sample copies of diagnostic reports for 2 years.
APHIS uses these records to compare the actual reports with the templates the laboratory
has submitted for use.
Request for Removal of Approved Status - (Private Sector) (State, Local, and Tribal
Government) – 9 CFR 71.22 (i)(3)
Laboratories voluntarily requesting removal of approved status do so in writing to VS.
This will make APHIS aware of a laboratory’s status for actual capacity or willingness to
conduct the activities APHIS has approved.
Appeal of Approval Denial, Suspension, or Removal – (Private Sector) (State, Local,
and Tribal Government) – 9 CFR 71.22(j)
If APHIS opts to deny or withdraw approval from a laboratory, the owner or operator of
that facility may appeal the denial or 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 listing. The owner
or operator of that establishment may also request a hearing on the matter. During the
hearing, the owner or operator may present arguments in support of continuing approval.
The request for this hearing must be made in writing by the owner or operator and sent
directly to the APHIS Administrator or the Administrator’s official designee within 30
days of the laboratory’s receipt of the NVSL Director’s decision. Responses to these
appeals would be provided within 60 days of receipt by APHIS.
3. Describe whether, and to what extent, the collection of information involves the
use of automated, electronic, mechanical, 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 Notification for Intent to Request Approval can be made via telephone or email to
APHIS.
APHIS is preparing fillable forms or similar documents for the following activities which
respondents will be able to submit to APHIS via email or hard copy:
• Application for APHIS Approval and Renewal.
• Checklist and Agreement.
• Quality Document Verification Form.

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The following activities can be submitted via email or hard copy:
• Documentation of Accreditation Status.
• Documentation of Implemented Quality System.
• Quality Assurance/Control Plans.
• Notification of Proposed Changes to Assay Protocols.
• Reporting.
• Test Exemption.
• Submission of Sample Copies of Diagnostic Reports.
• Request for Removal of Approved Status.
• Appeal of Approval Denial, Suspension, or Removal
All recordkeeping activities may be maintained electronically.
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 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. APHIS uses the information to ensure that the laboratories approved to
help assess the nation’s animal health status through targeted surveillance are capable of
producing quality test results. The appropriate review and approval of these laboratories
will enhance early detection of foreign animal disease agents and newly emerging
diseases and allow us to better respond to animal health emergencies (including
bioterrorist events) that threaten the nation’s food supply and public health.
5. If the collection of information impacts small businesses or other small entities,
describe any methods used to minimize burden.
APHIS estimates that all of the private sector respondents could be considered small
entities. However, the information APHIS collects in connection with this program is the
absolute minimum needed to ensure that laboratories comply with APHIS-approved
testing procedures.
6. Describe the consequences 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 APHIS did not collect this information, APHIS could not:
• Ensure a national ability to coordinate actions to prevent foreign animal disease
outbreaks in the United States.

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Maintain a state-of-the-art infrastructure for a Federal-State diagnostic laboratory
system to receive confirmed and accurate test results and support response actions for
all animal health events, from routine surveillance monitoring to large-scale outbreaks.

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;
Laboratories would have to submit test results in periods ranging from 24
hours to 30 days depending on the type test and the disease in question.
If APHIS opts to deny or withdraw approval from a laboratory, the owner or
operator of that facility may appeal the denial or withdrawal 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,
government contract, grant-in-aid, or tax records for more than 3 years;
APHIS requires that laboratories keep record for 5 years to ensure that
animals can be traced in the event of a disease outbreak.

•

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 collection to be
conducted in a manner inconsistent with the general information collection guidelines
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, frequency of collection, the clarity of instructions and
recordkeeping, disclosure, or reporting from, 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 the following respondents by email and phone to discuss the information
APHIS collects to conduct its laboratory approval process. APHIS discussed with them how
APHIS 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.

Andy Schwartz, D.V.M.
Interim Executive Director
Texas Animal Health Commission
2105 Kramer Lane
Austin TX 78758-4013
Office: 512-719-0715
[email protected]
Kent Fowler
Chief of Animal Health Branch
California Department of Food and Agriculture
1220 N Street
Sacramento, California, U.S.A. 95814
[email protected]
Mike Herrin
Oklahoma Assistant State Veterinarian
2800 N. Lincoln Blvd.
Oklahoma City, OK 73105
405-522-6142
[email protected]
APHIS’ proposed rule (Docket Number APHIS-2016-0054) published in the Federal
Register on Thursday, May 30, 2019. It describes its information gathering requirements,
among other things, and also provides a 60-day comment period. During this time,
interested members of the public have the opportunity to provide APHIS with their input
concerning the usefulness, legitimacy, and merit of the information collection activities
APHIS is proposing.

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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 and attitudes, religious beliefs, and others that are considered
private. This justification should include the reasons why the agency considers the
questions necessary.
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 83-1.
See APHIS Form 71. Burden estimates were developed from discussions with State,
university, and private laboratory personnel.
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 $3,061,797.01. APHIS
arrived at this figure by multiplying the hours of estimated response time (37,697 hours)
by the estimated average hourly wage of the above respondents ($55.23), and then
multiplying the result ($2,082,005.31) by 1.4706 to capture benefit costs.
The average hourly rates of $48.81 for veterinarians (used for State animal health
officials) and $61.65 for natural science managers (used for laboratory directors) is
derived from the U.S Department of Labor; Bureau of Labor Statistics March 2017
Report – National Compensation Survey: Occupational Employment and Wages, May
2018. See http://www.bls.gov/oes/#tables.
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According to DOL BLS news release USDL-18-1499, dated September 18, 2018 (see
https://www.bls.gov/news.release/pdf/ecec.pdf), benefits account for 32 percent of
employee costs, and wages account for the remaining 68 percent. Mathematically, total
costs can be calculated as a function of wages using a multiplier of 1.4706.
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 estimated 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 $271,763.74
(See APHIS Form 79.)
15. Explain the reasons for any program changes or adjustments reported in Items
13 of 14 of the OMB Form 83-1.
Program
Program
Change Due to Change Due to
Change Due Change Due to Adjustment in
Potential
Previously
Requested
to New
Agency
Agency
Violation of the Approved
Statute
Discretion
Estimate
PRA
Annual
Number of
Responses

5,306

0

0

0

0

0

Annual Time
Burden (Hr)

37,697

0

0

0

0

0

Annual Cost
Burden ($)

0

0

0

0

0

0

This is a new information collection resulting in 37,697 total burden hours.
16. For collections of information whose results are planned to be published, outline
plans for tabulation and publication.

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APHIS has no plans to publish information it collects in connection with this program.
17. If seeking approval to not display the expiration date of OMB approval of the
information collection, explain the reasons that display would be inappropriate.
Not applicable. APHIS will display the expiration date on any forms associated with this
action.
18. Explain each exception to the certification statement identified in the
“Certification for Paperwork Reduction Act.”
APHIS is able to certify compliance with all the provisions in the Act.
B. Collections of Information Employing Statistical Methods.
Statistical methods are not used in this information collection.

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