Approval of Laboratories To Conduct Official Testing; Consolidation of Regulations, 4192-4196 [2020-01114]

Agencies

• DEPARTMENT OF AGRICULTURE
• Animal and Plant Health Inspection Service

[Federal Register Volume 85, Number 16 (Friday, January 24, 2020)]
[Rules and Regulations]
[Pages 4192-4196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01114]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Parts 71, 75, 80, and 93

[Docket No. APHIS-2016-0054]
RIN 0579-AE46


Approval of Laboratories To Conduct Official Testing; 
Consolidation of Regulations

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are consolidating the regulations governing diagnostic 
laboratory approval authorities for select animal diseases into a 
single regulation and establishing a set of standard procedures that we 
will use to conduct future diagnostic laboratory approvals. These 
consolidated regulations will provide for consistent inspection 
protocols, proficiency testing methods, quality system guidelines, and 
definitions and will facilitate the approval of additional laboratories 
in emergency situations. The consolidated regulations will serve to 
simplify regulatory oversight and compliance.

DATES: February 24, 2020.

FOR FURTHER INFORMATION CONTACT: Dr. Randall L. Levings, Scientific 
Advisor, Diagnostics and Biologics, VS, APHIS, 1920 Dayton Ave., Ames, 
IA 50010-9602; (515) 337-7601.

SUPPLEMENTARY INFORMATION:

Background

    The regulations in 9 CFR subchapters B, C, and D pertain to the 
cooperative control and eradication of livestock or poultry diseases 
(subchapter B), the interstate transportation of animals (including 
poultry) and animal products (subchapter C), and the exportation and 
importation of animals (including poultry) and animal products 
(subchapter D).
    In a proposed rule \1\ published in the Federal Register on May 30, 
2019 (84 FR 25013-25018, Docket No. APHIS-2016-0054), we proposed to 
consolidate the regulations governing diagnostic laboratory approval 
authorities for animal diseases covered by 9 CFR subchapters B through 
D into a single regulation and establish a set of standard procedures 
that we would use to conduct future diagnostic laboratory

[[Page 4193]]

approvals. The consolidated regulations are intended to provide for 
consistent inspection protocols, proficiency testing methods, quality 
system guidelines, and definitions; facilitate the approval of 
additional laboratories in emergency situations; and simplify 
regulatory oversight and compliance.
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    \1\ To view the proposed rule, supporting documents, and the 
comments we received, go to https://www.regulations.gov/docket?D=APHIS-2016-0054.
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    We solicited comments for 60 days ending on July 29, 2019. We 
received six comments by that date, from private citizens and a State 
animal health commission. All the commenters generally supported the 
proposed rule. One commenter did raise a few questions, which are 
discussed below.
    As part of the proposed rule, we proposed to remove the specific 
laboratory approval provisions found in our regulations regarding 
equine infectious anemia, Johne's disease, and contagious equine 
metritis. One commenter noted that the scope of the proposed 
regulations could appear to be limited to those three diseases, but 
stated they favored a more expansive interpretation that would include 
all the diseases cited in 9 CFR subchapters B, C, and D.
    The commenter's more expansive interpretation is correct. As stated 
in proposed Sec.  71.22(a), State, university, and private laboratories 
must obtain Animal and Plant Health Inspection Service (APHIS) approval 
to conduct official testing for those diseases covered by subchapters 
B, C, and D and must meet the requirements of Sec.  71.22 in order to 
obtain and maintain that approval.
    The same commenter stated that it should be clear that regulations 
also apply to laboratories that test for other communicable diseases of 
livestock or poultry that the Secretary may determine constitute an 
emergency and pose a threat to animal health. In that vein, the 
commenter also encouraged APHIS to continue to develop regulations for 
a national list of reportable animal diseases.
    As anticipated by the commenter, the regulations will serve as the 
framework for the approval of laboratories that test for new or 
emerging communicable diseases of livestock or poultry for which tests 
are available should there be a need for those laboratories. We 
continue our work on developing regulations for a national list of 
reportable animal diseases.
    Finally, the commenter asked for clarity as to whether or not there 
are any potential user fees for laboratory approvals and inspections by 
APHIS personnel.
    User fees currently do apply with respect to some inspections 
conducted in connection with new or continuing approvals of 
laboratories, and those existing fees are not affected by this rule. 
Any new fees or adjustments to existing fees would be the subject of a 
separate regulatory action.

Revision to the Proposed Definition of National Animal Health 
Laboratory Network

    In the proposed rule, we proposed to define the term National 
Animal Health Laboratory Network (NAHLN) as ``a nationally coordinated 
network and partnership of Federal, State, and university-associated 
animal health laboratories that provide animal health diagnostic 
testing, methods research and development, and expertise for education 
and extension to detect biological threats to the nation's animal 
agriculture, thus protecting animal health, public health, and the 
nation's food supply.'' In this final rule, we are revising this 
proposed definition to indicate that the NAHLN is primarily composed of 
Federal, State, and university-associated animal health laboratories. 
This is because, on a case-by-case basis, private laboratories may be 
used in the NAHLN based on needed capabilities.

Clarification Regarding Laboratory Facility Approval

    In the proposed rule, proposed paragraph (b) of Sec.  71.22 
provided that official testing would have to be performed in laboratory 
facilities with controlled conditions, instrumentation appropriate for 
the testing being conducted, and biosecurity measures commensurate with 
the disease of diagnostic concern, but neglected to specify that each 
of these facility requirements must be acceptable to APHIS. In this 
final rule, we are clarifying that the determinations that the 
requirements have been met must be made by APHIS, rather than the 
facility itself.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document. Executive Orders 12866 and 13771 
and Regulatory Flexibility Act.
    This rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget. This rule is not an Executive 
Order 13771 regulatory action because it is not significant under 
Executive Order 12866.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov website (see footnote 1 above for a link to 
Regulations.gov).
    This rule consolidates existing diagnostic laboratory approval 
authorities for certain animal diseases into a single regulation and 
establishes a framework that we will use to conduct future diagnostic 
laboratory approvals. The consolidated regulations will serve to 
simplify regulatory oversight and compliance, saving time and 
resources. For both the laboratories and APHIS, consolidating and 
standardizing the process will create an easier-to-understand and more 
user-friendly approval process; improve efficiency in obtaining 
approvals to conduct testing for single or multiple diseases; reduce 
the administrative burden associated with obtaining and tracking 
laboratory approvals; and simplify the steps required to renew an 
existing approval.
    There are over 400 APHIS-approved laboratories. The laboratories 
range widely in size, from one-person practices to large, State-wide 
systems. They are classified within the Veterinary Services industry, 
for which the Small Business Administration's small-entity standard is 
annual receipts of not more than $7.5 million. For the industry overall 
in 2012, there were 27,939 establishments that operated throughout the 
year. Ninety-nine percent (27,605 establishments) had receipts of less 
than $5 million. Thus, most of these entities are small.
    Cost savings because of this rule would be realized mainly by 
approximately 50 larger laboratories due to the multiple tests they 
perform. In accordance with guidance on complying with Executive Order 
13771, the single primary estimate of the yearly savings that would be 
provided by this proposed rule is $1.1 million, the mid-point estimate 
annualized in perpetuity using a 7 percent discount rate.
    This rule will lessen the administrative burden for affected 
laboratories, benefiting rather than having any negative impact on 
them. Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action will 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12372

    This program/activity is listed in the Catalog of Federal Domestic 
Assistance under No. 10.025 and is subject to Executive Order 12372, 
which requires intergovernmental consultation with

[[Page 4194]]

State and local officials. (See 2 CFR chapter IV.)

Executive Order 12988

    This final rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. This rule: (1) Preempts all State and local laws 
and regulations that are in conflict with this rule; (2) has no 
retroactive effect; and (3) does not require administrative proceedings 
before parties may file suit in court challenging this rule.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the reporting and recordkeeping 
requirements included in this final rule, which were filed under 0579-
0472, have been submitted for approval to the Office of Management and 
Budget (OMB). When OMB notifies us of its decision, if approval is 
denied, we will publish a document in the Federal Register providing 
notice of what action we plan to take.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes. For information pertinent to E-Government Act 
compliance related to this rule, please contact Mr. Joseph Moxey, 
APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects

9 CFR Part 71

    Animal diseases, Livestock, Poultry and poultry products, 
Quarantine, Reporting and recordkeeping requirements, Transportation.

9 CFR Part 75

    Animal diseases, Horses, Quarantine, Reporting and recordkeeping 
requirements, Transportation.

9 CFR Part 80

    Animal diseases, Livestock, Transportation.

9 CFR Part 93

    Animal diseases, Imports, Livestock, Poultry and poultry products, 
Reporting and recordkeeping requirements.

    Accordingly, we are amending 9 CFR parts 71, 75, 80, and 93 as 
follows:

PART 71--GENERAL PROVISIONS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
2. Section 71.1 is amended by adding in alphabetical order definitions 
for ``Approved laboratory'', ``National Animal Health Laboratory 
Network (NAHLN)'', and ``Official testing'' to read as follows:


Sec.  71.1  Definitions.

* * * * *
    Approved laboratory. A laboratory approved by the Administrator to 
conduct official testing in accordance with the regulations in Sec.  
71.22.
* * * * *
    National Animal Health Laboratory Network (NAHLN). The NAHLN is a 
nationally coordinated network and partnership of primarily Federal, 
State, and university-associated animal health laboratories that 
provide animal health diagnostic testing, methods research and 
development, and expertise for education and extension to detect 
biological threats to the nation's animal agriculture, thus protecting 
animal health, public health, and the nation's food supply.
* * * * *
    Official testing. Testing to determine the disease status of 
animals for use in State-Federal programs. Tests are approved by the 
Administrator and conducted by qualified analysts in an approved 
laboratory.
* * * * *


Sec.  71.20  [Amended]

0
3. Section 71.20 is amended by redesignating footnote 7 as footnote 1.


Sec.  71.21  [Amended]

0
4. Section 71.21 is amended by redesignating footnotes 8 and 9 as 
footnotes 2 and 3, respectively.

0
5. Section 71.22 is added to read as follows:


Sec.  71.22  Approval of laboratories to conduct official testing.

    (a) Approvals. State, university, and private laboratories must 
obtain APHIS approval to conduct official testing for those diseases 
covered by subchapters B, C, and D of this chapter. Laboratories 
seeking approval must meet the requirements of this section.
    (b) Facilities. Official testing must be performed in laboratory 
facilities with controlled conditions, instrumentation appropriate for 
the testing being conducted, and biosecurity measures commensurate with 
the disease of diagnostic concern; each of these facility requirements 
must be acceptable to APHIS. Approved laboratories must agree to 
periodic, unannounced inspection by APHIS personnel or other APHIS-
approved inspectors following an APHIS-approved checklist.
    (c) Quality system. Laboratories must operate under a quality 
system acceptable to APHIS. Components of such systems include 
acceptable documentation of procedures, recordkeeping, training, 
reporting, and corrective actions taken if standards and procedures are 
not reached or maintained. Adherence to certain nationally or 
internationally established quality systems recognized by APHIS may be 
used to meet all or part of this requirement.\4\ Quality system records 
are subject to review during facility inspections.
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    \4\ A list of established quality systems recognized by APHIS is 
available on the internet at https://www.nahln.org.
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    (d) Procedures. All official testing must be conducted using APHIS-
approved assay methods,\5\ which may include standard operating 
procedures recognized by the National Veterinary Services Laboratories 
(NVSL) or National Animal Health Laboratory Network, and/or diagnostic 
test kits licensed by the USDA.
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    \5\ A list of approved assay methods is available on the APHIS 
Laboratory Portal website at https://www.nahln.org and at https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/animal-disease-information.
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    (e) Training. Official testing must be conducted only by those 
individuals who have completed APHIS-approved training and have passed 
proficiency tests administered by APHIS or its official designee. These 
tests will be administered annually or as necessary at an interval 
stipulated by APHIS. Supervisory oversight of official testing must be 
performed by qualified individuals, as determined by APHIS.
    (f) Reporting. Approved laboratories must report test results to 
APHIS and State animal health officials using an individualized (by 
disease) timeline established by APHIS at the time of laboratory 
approval.
    (g) Applications for approval. (1) Laboratories must use APHIS 
application forms, including an agreement to meet the obligations to 
APHIS listed in this section, and submit

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completed forms to the NVSL Director. The Director will make a 
preliminary determination of the application's acceptability, based on 
initial review of submitted materials and, when appropriate, a needs 
assessment for diagnostic capacity. These determinations are made on an 
annual basis, or as needed based on the number of applications 
received.
    (2) Applicants will be informed of the preliminary determination. 
If positive, applicants will then be able to request a facility 
inspection and personnel training, conducted in accordance with this 
section. If negative, APHIS will provide a rationale for the denial. 
Denied applicants may appeal any denials in accordance with the 
regulations in paragraph (j) of this section;
    (3) When all requirements in this section have been met, the NVSL 
Director will issue a final approval. Approvals are specific to those 
lab personnel working at the inspected, approved laboratory who have 
met the eligibility and proficiency requirements. Denied applicants may 
appeal any denials in accordance with the regulations in paragraph (j) 
of this section.
    (h) Maintenance of approved status. (1) Previously approved 
laboratories that wish to maintain their approved status must reapply 
for APHIS approval at least 1 month before their approval term expires, 
or at least every 2 years, whichever comes first. Laboratories wishing 
to maintain approved status must submit a renewal application form, as 
supplied by APHIS, to the NVSL Director.
    (2) Approved laboratories must have at least one individual with 
the required training and unexpired proficiency certification in their 
employ at all times.
    (3) Approved laboratories must perform the minimum number of tests 
to maintain proficiency, as stipulated by APHIS in the guidance 
documents developed for individual test types.
    (i) Probation, suspension, and rescission of laboratory approval. 
(1) Laboratories not conducting the minimum number of tests as required 
by paragraph (h)(3) of this section during a single reporting period 
will be assigned probationary status. A reporting period is less than 
or equal to the time for which the laboratory has been approved to 
conduct testing by APHIS. Laboratories on probation may continue to 
conduct official testing. If the minimum required number of tests are 
not performed during two consecutive reporting periods, the laboratory 
will not be eligible for renewal of APHIS approval. Exceptions to this 
requirement may be granted by the NVSL Director upon request.
    (2) Approval to conduct official testing will be suspended in the 
event that a laboratory experiences changes that may impact its ability 
to provide quality testing services. These changes include: 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. Laboratories with suspended status will not be approved to 
conduct official testing. Laboratories will be restored to approved 
status upon training and/or testing new personnel, successful 
inspection of new facilities, and/or correction of noncompliance 
issues. Reapproval will involve resubmitting those sections of the 
application materials required by the NVSL Director.
    (3) Approval may be rescinded at any time, at the discretion of the 
NVSL Director, if a laboratory fails to meet its obligations to APHIS, 
as listed in the agreement signed by the laboratory during the 
application process. The NVSL Director will issue a notice to the 
laboratory, providing the justification for the proposed removal. 
Laboratories will have 30 days to respond in writing to the concerns 
provided before the NVSL Director finalizes the removal decision.
    (j) Appeals. Appeal of any denial, probation, suspension, or 
rescission of laboratory approval must be made in writing 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 will be provided within 60 days of receipt by APHIS.

(Approved by the Office of Management and Budget under control 
number 0579-0472)

PART 75--COMMUNICABLE DISEASES IN HORSES, ASSES, PONIES, MULES, AND 
ZEBRAS

0
6. The authority citation for part 75 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
7. Section 75.4 is amended as follows:
0
a. By revising the section heading;
0
b. In paragraph (a), by removing the definition of Official test and by 
revising the definition of Reactor; and
0
c. By removing paragraphs (c) and (d).
    The revisions read as follows:


Sec.  75.4  Interstate movement of equine infectious anemia reactors.

    (a) * * *
    Reactor. Any horse, ass, mule, pony or zebra which is subjected to 
an official test in accordance with the regulations in Sec.  71.22 of 
this subchapter and found positive.
* * * * *

PART 80--JOHNE'S DISEASE IN DOMESTIC ANIMALS

0
8. The authority citation for part 80 continues to read as follows:

    Authority:  7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.


0
9. In Sec.  80.1, the definition of ``Official Johne's disease test'' 
is revised to read as follows:


Sec.  80.1  Definitions.

* * * * *
    Official Johne's disease test. An organism detection test approved 
by the Administrator and conducted in a laboratory approved by the 
Administrator.\1\
* * * * *

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    \1\ The list of approved laboratories is available on the 
internet at https://www.nahln.org or upon request from the Animal 
and Plant Health Inspection Service, Veterinary Services, National 
Veterinary Services Laboratories, P.O. Box 844, Ames, IA 50010-0844.

PART 93--IMPORTATION OF CERTAIN ANIMALS, BIRDS, FISH, AND POULTRY, 
AND CERTAIN ANIMAL, BIRD, AND POULTRY PRODUCTS; REQUIREMENTS FOR 
MEANS OF CONVEYANCE AND SHIPPING CONTAINERS

0
10. The authority citation for part 93 continues to read as follows:

    Authority:  7 U.S.C. 1622 and 8301-8317; 21 U.S.C. 136 and 136a; 
31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.4.


Sec.  93.301  [Amended]

0
11. Section 93.301 is amended as follows:
0
a. In paragraphs (e)(2)(iii) and (e)(5)(i), by removing the words 
``paragraph (i) of this section'' and adding the words ``Sec.  71.22 of 
this chapter'' in their place; and
0
b. By removing and reserving paragraph (i).


Sec.  93.303  [Amended]

0
12. Section 93.303 is amended by redesignating footnote 12 as footnote 
10.


Sec.  93.308  [Amended]

0
13. Section 93.308 is amended by redesignating footnotes 13, 14, and 15 
as footnotes 11, 12, and 13, respectively.


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    Done in Washington, DC, this 17th day of January 2020.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-01114 Filed 1-23-20; 8:45 am]
 BILLING CODE 3410-34-P