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Federal Register
Vol. 85, No. 64
Thursday, April 2, 2020

This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
9 CFR Parts 57 and 161
[Docket No. APHIS–2017–0002]
RIN 0579–AE39

National List of Reportable Animal
Diseases
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:

We are proposing to amend
the animal disease regulations to
provide for a National List of Reportable
Animal Diseases, along with reporting
responsibilities for animal health
professionals that encounter or suspect
cases of communicable animal diseases
and disease agents. These proposed
changes are necessary to streamline
State and Federal cooperative animal
disease detection, response, and control
efforts. This action would consolidate
and enhance current disease reporting
mechanisms, and would complement
and supplement existing animal disease
tracking and reporting at the State level.
DATES: We will consider all comments
that we receive on or before June 1,
2020.
SUMMARY:

You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
http://www.regulations.gov/#!docket
Detail;D=APHIS-2017-0002.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2017–0002, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
Supporting documents and any
comments that we receive on this
docket may be viewed at http://
www.regulations.gov/#!docket
Detail;D=APHIS-2017-0002 or in our
reading room, which is located in room
1141 of the USDA South Building, 14th

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ADDRESSES:

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Street and Independence Avenue SW,
Washington, DC. Normal reading room
hours are 8 a.m. to 4:30 p.m., Monday
through Friday, except holidays. To be
sure someone is there to help you,
please call (202) 799–7039 before
coming.
FOR FURTHER INFORMATION CONTACT: Dr.
Rebecca Jones, Strategy and Policy,
Centers for Epidemiology and Animal
Health, 2150 Centre Ave. Bldg. B, Fort
Collins, CO 80526; (970) 494–7196.
SUPPLEMENTARY INFORMATION:
Background
Under the Animal Health Protection
Act (AHPA, 7 U.S.C. 8301 et seq.), the
Secretary of Agriculture has the
authority to issue orders and promulgate
regulations to prevent the introduction
into the United States and the
dissemination within the United States
of any pest or disease of livestock. The
Secretary has delegated authority to
issue such orders and regulations to the
Animal and Plant Health Inspection
Service (APHIS).
The regulations in 9 CFR subchapter
B (referred to below as the regulations)
govern the cooperative control and
eradication of livestock or poultry
diseases within the United States. The
regulations establish procedures
through which Federal and State animal
health authorities coordinate in their
collective efforts to eradicate certain
communicable animal diseases;
included provisions govern the payment
of indemnities, animal identification
and testing, and specific disease
containment procedures.
Accurate and timely reporting of
diagnosed or suspected animal diseases
and disease agents to State and Federal
animal health authorities is vital to
preventing disease spread and
protecting American agriculture. Under
the AHPA, the Secretary of Agriculture
has authority to respond to diseases
through movement control,
surveillance, and other activities
including disease reporting; however, at
present, the United States lacks a
comprehensive nationwide approach to
animal disease reporting requirements.
Reporting requirements do exist for
accredited veterinarians under 9 CFR
161.4(f): Accredited veterinarians are
required to immediately report to
APHIS and the State Animal Health
official all diagnosed suspected cases of
communicable disease for which APHIS

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has a control or eradication program in
9 CFR chapter I, and all diagnosed and
suspected cases of animal diseases not
known to exist in the United States as
provided in 9 CFR 71.3. (Within § 71.3,
paragraph (b) lists foreign animal
diseases not known to exist in the
United States, and prohibits the
interstate movement of animals affected
with such diseases, as well as any other
communicable foreign diseases.)
However, these reporting obligations
do not cover all animal diseases listed
by the World Organization for Animal
Health (OIE), leaving critical gaps in
nationwide reporting for many diseases.
Not having a consistent and uniform
national system for reporting animal
diseases and disease agents creates
challenges for the United States when
fulfilling its international reporting
requirements. As a Member country of
the OIE, the United States must submit
to the OIE reports on the status of
certain diseases of livestock, poultry,
aquaculture, bees and, in some
instances, wild terrestrial and aquatic
species. Some of these reportable
diseases have the potential for rapid
spread, regardless of national borders,
are of serious socioeconomic or public
health consequence, and impact the
international trade of animals and
animal products. Moreover, a 2015 U.S.
Government Accountability Office
(GAO) report 1 noted the role that gaps
in animal disease reporting played in
recent disease outbreaks and
recommended that the United States
Department of Agriculture (USDA)
clarify roles and responsibilities to
facilitate how the Agency responds to
emerging animal diseases.
In addition to the current required
disease reporting from APHISaccredited veterinarians, States
voluntarily report occurrences of
monitored diseases–i.e., diseases or
conditions where occurrence is
routinely tracked by APHIS and data are
used to monitor changes in a given
population and its environment, or to
report on disease occurrence—to APHIS
on a monthly basis through the National
Animal Health Reporting System
(NAHRS), a web-based reporting system
for animal disease-related
transmissions. Such voluntary reporting
of monitored diseases assists in national
data collection for the diseases. This
1 See

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data is used to monitor changes in a
given population and its environment,
or to report on disease occurrence.
However, States are not currently
required to report occurrences of
monitored diseases and some diseases
(such as emerging diseases) to APHIS,
nor is there a Federal requirement that
laboratories must report detection of
these diseases to States. The proposed
disease reporting requirements would
help State, Federal, and industry
officials to document and monitor
national and State disease trends, meet
travel and movement requirements, and
evaluate and implement management,
control, response, and prevention
activities for animal disease.
Finally, no standard reporting
requirements, guidelines, or timeframes
exist under current Federal regulations
for animal health professionals other
than accredited veterinarians who
encounter or suspect cases of
communicable animal diseases and
disease agents. For purposes of this
document as well as the proposed
regulations, by animal health
professional, we mean an individual,
corporate entity, or animal health
organization with formal training in the
diagnosis or recognition of animal
diseases and/or pests of livestock.2
Examples of animal health professionals
include, but are not limited to,
veterinary medical professionals,
diagnostic laboratorians, biomedical
researchers, public health officials,
animal health officials, trained
technicians, zoo personnel, and wildlife
personnel with such training.
In this document, we are proposing to
add a new part to 9 CFR subchapter B
that would provide for a new National
List of Reportable Animal Diseases
(NLRAD), as well as disease reporting
requirements for animal health
professionals identifying or suspecting
NLRAD-listed diseases or conditions.
The proposed amendments for disease
listing and reporting would accomplish
the following:
• Establish the NLRAD with two
categories: Notifiable diseases and
conditions, and monitored diseases. The
notifiable diseases and conditions
would be subdivided into emergency
incidents, emerging disease incidents,
and regulated disease incidents.
Monitored diseases would be diseases
or conditions where occurrence is
routinely tracked by APHIS and data are
used to monitor changes in a given
2 Please note that the AHPA, as well as this
proposed rule, defines livestock as: ‘‘All farm-raised
animals.’’ This includes bees, farmed aquaculture,
and animals maintained in captivity on a farm.

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population and its environment, or to
report on disease occurrence.
• Specify reporting responsibilities
for animal health professionals
encountering animal diseases, disease
agents, or conditions listed as monitored
or notifiable.
• Indicate the existence of an NLRAD
System Standards document, and
provide procedures for its use.
The proposed amendments would
address GAO recommendations by
enhancing and clarifying national
animal disease reporting guidelines for
veterinarians, and by expanding
reporting requirements to include other
animal health professionals who may
encounter such diseases—including
veterinary medical professionals,
diagnostic laboratorians, biomedical
researchers, public health officials,
animal health officials, trained
technicians, zoo personnel, and wildlife
personnel. While the vast majority of
reporting of NLRAD-listed diseases and
conditions is expected to be through
accredited veterinarians and diagnostic
laboratories, due to the serious nature of
notifiable diseases and their potentially
damaging impact on U.S. agriculture,
immediate reporting would be required
by any animal health professional with
knowledge or suspicion of these
diseases. To aid in identifying suspicion
of disease, APHIS would maintain case
definitions at the following website:
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases.
The process to report diseases listed
as ‘monitored’ in the NLRAD would
remain largely the same as in current
practice, where States track and report
information on monitored diseases to
APHIS. The primary differences from
current practice would be that such
reporting from States would become
mandatory, rather than voluntary, and
that laboratories encountering
confirmed cases of monitored diseases
would be required to report occurrence
information to the State where the
animal is located. Reporting of
additional follow-up information by
States and laboratories to APHIS—such
as the number of diagnostic tests
conducted, number of detections, and
epidemiological information—may be
requested for some monitored diseases
in response to a disease report or
following consultation with
stakeholders. Although the NAHRS is
the current information technology
system used for most monitored disease
reporting from States, we are preparing
to implement a new designated
information technology system that
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collecting animal disease-related data
on a national scale. Once fully
operational, this system would be
available on the APHIS website at:
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/monitoring-andsurveillance/sa_disease_reporting/ct_
usda_aphis_animal_health. The formal
name for this system, once finalized,
would be noted on the website and
referenced in subsequent rulemakings.
Animal health professionals
suspecting or diagnosing incidences of
animal diseases or disease agents
classified as ‘‘notifiable’’ in the NLRAD
would be required to immediately
report to both State and Federal
officials. More detailed information
regarding these proposed reporting
requirements is included in the next
section.
APHIS intends for the NLRAD to be
codified as a single, nationally
supported, standardized list of
reportable animal diseases and disease
agents that would allow for consistent
disease reporting. The benefits of
improving animal disease tracking and
reporting on a national scale would
extend to national, interstate, and
international commerce, emergency
disease response, and international
reporting obligations to OIE as well as
trading partners.
Our proposed animal disease list
information and reporting requirements
would be contained in a new 9 CFR part
57. Proposed § 57.1 would contain
definitions related to animal health
testing and diagnostics. Provisions for
the NLRAD and reporting requirements
would be included in proposed § 57.2.
We also are proposing to amend the
existing reporting requirements for
APHIS-accredited veterinarians in
§ 161.4 to make these consistent with
the new NLRAD provisions. We will
address below the proposed changes in
detail.
Definitions (§ 57.1)
We propose to incorporate standard
definitions for terms that currently exist
elsewhere in the regulations. We would
define Animal and Plant Health
Inspection Service (APHIS) as the
Animal and Plant Health Inspection
Service of the United States Department
of Agriculture. We would define
livestock to refer to all farm-raised
animals. We also would define State to
refer to any State, the District of
Columbia, Puerto Rico, Guam, the
Northern Mariana Islands, the Virgin
Islands of the United States, and any
other territory or possession of the
United States. United States would refer
to all of the States.

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We propose to add new definitions for
animal health professional, monitored
disease, and notifiable disease, in
accordance with their usage in the
NLRAD and its provisions set forth in
proposed § 57.2.
As noted earlier in this document,
animal health professional would be
defined as an individual, corporate
entity, or animal health organization
with formal training in the diagnosis or
recognition of animal diseases and/or
pests of livestock. The definition would
further provide examples of types of
professions that include animal health
professionals: Veterinary medical
professionals, diagnostic laboratorians,
biomedical researchers, public health
officials, animal health officials, trained
technicians, zoo personnel, and wildlife
personnel.
These examples would be illustrative,
rather than exhaustive. The salient
criterion in determining whether APHIS
would consider the individual an
animal health professional would be
their formal training in the diagnosis or
recognition of animal diseases and/or
pests of livestock, not their profession.
At a minimum, we would consider
training programs administered by
APHIS, a State department of
agriculture, a State department of
wildlife management and/or natural
resources, or a licensed, accredited
college or university to constitute
formal training. We request specific
public comment on the types of training
that should constitute formal training,
and whether adding a definition of
formal training to our proposed
regulations would be beneficial.
Monitored disease would be defined
as a disease or condition where
occurrence is routinely tracked by
APHIS and data are used to monitor
changes in a given population and its
environment, or to report on disease
occurrence. Notifiable disease would be
defined as a disease or condition that
requires immediate notification to
Federal and State veterinary authorities.
Notifiable diseases would be: (1)
Emergency incidents (foreign animal
diseases, exotic vectors, and high
priority diseases); (2) emerging disease
incidents (involving diseases,
infections, or infestations with agents
that are unknown, newly identified, or
previously identified but
epidemiologically changed); and (3)
regulated disease incidents (involving
diseases for which Federal regulations
already are in place).
Finally, because we make frequent
reference to the NLRAD System
Standards Document—a document
released with this proposed rule—we
propose to include a definition for

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NLRAD System Standards Document.
This document would provide specific
details on the diseases and disease
agents to be reported, standard
operating procedures, and additional
background and resources to support
reporting efforts. The document would
also be available on APHIS’ website at
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases.
National List of Reportable Animal
Diseases (§ 57.2)
Section 57.2 would describe the
National List of Reportable Animal
Diseases (NLRAD). This section would
outline the organization, as well as
maintenance, of the NLRAD, and would
specify new reporting requirements for
animal health professionals who
encounter or suspect incidences of
notifiable animal diseases and disease
agents, and new reporting requirements
for States and laboratories who
encounter confirmed cases of monitored
animal diseases.
Proposed paragraph (a) would note
the location of the NLRAD on the
APHIS website and specify appropriate
contact information for interested
parties to obtain paper copies of the list.
Proposed paragraph (b) would outline
the division of the NLRAD into two
categories: Notifiable diseases and
conditions, and monitored diseases.
Notifiable diseases and conditions
would be subdivided into emergency
incidents (foreign animal diseases,
exotic vectors, and high priority
diseases), emerging disease incidents
(involving diseases, infections, or
infestations with agents that are
unknown, newly identified, or
previously identified but
epidemiologically changed), and
regulated disease incidents (involving
diseases for which Federal regulations
already are in place). Monitored
diseases, as our proposed definition
above indicates, are diseases where
occurrence is routinely tracked by
APHIS and data are used to monitor
changes in a given population and its
environment, or to report on disease
occurrence. A disease or condition
listed as notifiable would be reportable
immediately in accordance with
procedures specified in proposed
§ 57.2(d), with additional reporting
resources provided in the NLRAD
System Standards Document. Monitored
diseases would be the subject of
required periodic summary reports, in
keeping with existing practices.
Proposed paragraph (c) would specify
that any changes to the NLRAD would
be announced via notice in the Federal

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Register, and that updates and edits to
the list would be considered when: An
emerging disease is identified; changes
are made to OIE-Listed diseases,
infections, and infestations; changes are
made in VS regulations; changes are
made on the National Veterinary
Stockpile (NVS) list, USDA Select
Agents and Toxins list, or Centers for
Disease Control and Prevention’s (CDC)
Category A, B, or C Bioterrorism Agents/
Diseases list (described below); or
changes or additions are requested by
stakeholders and adopted by APHIS.
The NVS provides support to States,
Tribes, and Territories responding to
damaging animal disease outbreaks, and
its list comprises damaging animal
disease threats. The USDA Select
Agents and Toxins list indicates
biological agents and toxins determined
to have the potential to pose a severe
threat to human and animal health; and
the CDC Category A, B, and C
Bioterrorism Agents/Diseases list
includes agents or diseases in the
United States that pose a risk to national
security due to ease of transmission
and/or public health impact.
Stakeholders who wish to request
removals or additions to the NLRAD
would need to submit their requests in
writing in accordance with the contact
information listed in proposed § 57.2(a).
Written requests would require a
justification for the proposed change,
with examples of such justifications
available in the NLRAD System
Standards document.
Proposed paragraph (d) would specify
reporting procedures for those who
encounter or suspect notifiable or
monitored diseases. For notifiable
diseases, any animal health professional
with knowledge of occurrence or
suspected occurrence of an animal
disease, disease agent, or condition
listed as notifiable in the NLRAD would
be required to immediately report such
identification or suspicion to both
APHIS and the State where the livestock
is located. Animal health professionals
would be required to report notifiable
diseases and disease agents to APHIS as
described on the NLRAD website,
available at https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases, or by
contacting their local APHIS office.3
Reporting to the State would be to the
State animal health official listed at
https://www.aphis.usda.gov/aphis/
3 Contact information for APHIS offices can be
found on the APHIS website at https://
www.aphis.usda.gov/aphis/banner/contactus, or in
the local phone directory.

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ourfocus/animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases for the State
in question.
We acknowledge that we would
require dual reporting of notifiable
diseases and disease agents: Once to
APHIS, and again to the State where the
animal is located. We explored
alternative options that would have
established a single point of contact: i.e.,
either the State where the animal is
located or APHIS. However, not all
States have a single portal for receiving
reports of all notifiable diseases, and
divisions of animal health or animal
industry have varying staffing levels.
The lack of a standardized portal,
coupled with staffing constraints, could
result in delays receiving reports
regarding notifiable diseases, and,
consequently, delays relaying these
reports to APHIS. Depending on the
nature of the notifiable disease reported,
such a delay could have not only animal
health implications, but also
implications related to public health or
international trade. Delays in receiving
reports can directly affect trade, insofar
as APHIS is required as a member of the
OIE to immediate report disease
occurrence to the OIE and to
international trading partners for many
notifiable diseases.
Conversely, State animal health
personnel often serve as first responders
for epidemiological investigations in
response to possible animal disease
outbreaks. If APHIS were the sole point
of contact for notifiable diseases, any
delays in relaying the report to the State
where the animal is located could
directly adversely impact disease
response and potentially contribute to
disease spread. We also took into
consideration that many State
regulations require veterinarians and
laboratories to report notifiable diseases
to the State.
Based on these considerations, we
have concluded that dual reporting of
notifiable diseases is warranted for the
notifiable diseases in the NLRAD. That
being said, we will continue to explore
means of establishing a single portal for
both Federal and State personnel to
receive notifiable disease reports. If this
occurs, we would amend the regulations
accordingly.
For monitored diseases, laboratories
would be required to report occurrence
information of confirmed cases of an
animal disease or condition listed as
monitored in the NLRAD on a monthly
basis to the State where the animal is
located by contacting the State animal
health official listed at https://
www.aphis.usda.gov/aphis/ourfocus/
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surveillance/sa_disease_reporting/ct_
usda_aphis_animal_health. States
would be required to report occurrence
information of confirmed cases of
monitored diseases to APHIS on a
monthly basis through the new
designated information technology
system portal.
The animal diseases and disease
agents to be reported, standard
operating procedures, and additional
background and resources to support
reporting efforts would be located in the
supplemental NLRAD System Standards
Document, a draft of which is available
as a supporting document for this
proposed rule (see ADDRESSES above).
Updates to this document would be
announced as needed via notice in the
Federal Register. The notice would
provide for a public comment period.
Finally, while we intend the
regulations to be the general framework
for reporting known and suspect
occurrences of notifiable and monitored
diseases, it is possible that APHIS could
issue regulations or a Federal Order that
requires an alternative reporting
structure based on, for example, the
epidemiology of the disease. To account
for discrepancies that could arise if we
were to issue such regulations or such
an order, we would state that the
NLRAD regulations do not supersede
such a reporting structure.
Standards for Accredited Veterinarian
Duties (§ 161.4)
We propose to amend paragraph (f) of
this section to clarify reporting
requirements for APHIS-accredited
veterinarians. The revised requirements
for veterinarians would align with the
new proposed reporting responsibilities
as described under § 57.2, that require
any accredited veterinarian with
knowledge of occurrence or suspected
occurrence of an animal disease, disease
agent, or condition listed as notifiable in
the NLRAD to immediately report such
identification or suspicion to State and
Federal authorities. As we mentioned
earlier in this document, we expect the
vast majority of the reporting of
notifiable diseases to continue to be
done by accredited veterinarians;
therefore, it is important that accredited
veterinarians follow the reporting
requirements of the NLRAD regulations.
Reporting of Notifiable Diseases of
Livestock in Wildlife
Several of the diseases on our
proposed list of notifiable diseases
could be transmitted from wildlife to
livestock, and a few have known
wildlife reservoirs. To account for this,
we contemplated whether to propose
that notifiable diseases would need to

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be reported whenever they are detected
in wildlife.
While such reporting would clearly
assist in the aims of the NLRAD, we also
acknowledge factors that could
adversely impact implementation of
such a reporting requirement. First, as
several commenters on a proposed rule
to revise and consolidate our domestic
brucellosis and bovine tuberculosis
programs (80 FR 78462–78520, Docket
No. APHIS–2011–0044) pointed out, a
number of States limit the authority of
State animal health officials to livestock
within the State, and effectively
preclude the officials from conducting
epidemiological investigations of
wildlife unless livestock within the
State are already known or suspected to
be infected with a disease of livestock.
Second, as other commenters on that
proposed rule pointed out, several
States do not allow wildlife authorities
to test for certain diseases of livestock,
which would effectively limit reporting
of disease occurrence in wildlife in
those States to suspected occurrence.
Finally, as several commenters on that
proposed rule pointed out, wildlife
populations are often itinerant, making
it difficult to identify a particular
infected animal within the population.
For these reasons, we elected not to
propose to require reporting of
notifiable diseases in wildlife within
our proposed NLRAD regulations.
However, we do request public
comment regarding how the occurrence
of notifiable diseases in wildlife should
best be addressed within the NLRAD,
especially when reservoirs of a
notifiable disease are determined to
exist in wildlife within a State.
Executive Orders 12866 and 13771 and
Regulatory Flexibility Act
This proposed 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
proposed rule is not expected to be an
Executive Order 13771 regulatory action
because this proposed rule is not
significant under Executive Order
12866.
In accordance with 5 U.S.C. 603, we
have performed an initial regulatory
flexibility analysis, which is
summarized below, regarding the
economic effects of this proposed rule
on small entities. Copies of the full
analysis are available by contacting the
person listed under FOR FURTHER
INFORMATION CONTACT or on the
Regulations.gov website (see ADDRESSES
above for instructions for accessing
Regulations.gov).

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Based on the information we have,
there is no reason to conclude that
adoption of this proposed rule would
result in any significant economic effect
on a substantial number of small
entities. However, we do not currently
have all of the data necessary for a
comprehensive analysis of the effects of
this proposed rule on small entities.
Therefore, we are inviting comments on
potential effects. In particular, we are
interested in determining the number
and kind of small entities that may
incur benefits or costs from the
implementation of this proposed rule.
APHIS is proposing to amend the
animal disease regulations to provide
for a National List of Reportable Animal
Diseases (NLRAD) along with animal
disease reporting responsibilities, to
streamline State and Federal
cooperative animal disease eradication
efforts. This action would enhance and
consolidate current disease reporting
mechanisms, and would complement
and supplement existing animal disease
tracking and reporting at the State level.
The Regulatory Flexibility Act
requires agencies to consider whether a
rule will have a significant economic
impact on a substantial number of small
entities. The size of a business may have
a bearing on its ability to comply with
a proposed regulation and there may be
unintended or unforeseen adverse
impacts. Using the North American
Industry Classification System (NAICS),
the Small Business Administration
(SBA) defines small businesses in terms
of a firm’s annual receipts or number of
employees. It is likely that most of the
entities that may be affected by the
proposed rule are small.
Although the process to report
diseases listed as ‘‘monitored’’ in the
NLRAD largely would remain the same,
reporting requirements would change.
Currently, States track and report
information on monitored diseases to
APHIS. However, under the proposed
rule, reporting from States would
become mandatory, rather than
voluntary, and laboratories
encountering cases of monitored
diseases would be required to report
occurrence information to the State
where the animal is located. Also,
reporting of additional information by
States and laboratories would be
requested for some monitored diseases.
The process to report diseases listed as
‘‘notifiable’’ in the NLRAD would for
the most part be new. Animal health
officials suspecting or diagnosing
incidences of notifiable diseases would
be responsible for reporting suspected
or diagnosed cases of all animal diseases
or disease agents classified as notifiable

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in the NLRAD to both State and Federal
officials.
Based on estimates from the NLRAD
program, the number of laboratory
reports could increase from about 6,600
to between 59,400 and 66,000 reports
per year, and increase the total
processing time for monitored diseases
from about 3,300 hours to between
18,150 and 18,700 hours per year. In
addition, the NLRAD program
anticipates reports of diseases newly
added to the Notifiable list, thereby
increasing the annual processing time
for notifiable diseases from about 3,200
hours to between 3,400 and 3,700 hours.
The NLRAD program estimates potential
additional public and private sector
costs that may result from the proposed
rule would range from $353,000 to
$373,000 per year. Increased Federal
and State administrative workloads
would be resolved by reallocating
program resources.
Benefits of the proposed rule are less
quantifiable. However, the losses
associated with the detection of
livestock diseases in the United States
can be substantial. For example, the
2003 detection of bovine spongiform
encephalopathy in the United States led
beef exports to fall by about $3 billion
in 1 year. The NLRAD is an important
component of a comprehensive and
integrated National-State foreign animal
disease (FAD) surveillance system that
provides key U.S. information used to
complete reports about diseases as
required by OIE. Early identification,
detection, and control of FADs,
particularly zoonotic diseases, helps
maintain domestic production and
export markets. FADs can result in
productivity losses which may increase
the cost of food products obtained from
those animal sources. NLRAD
information provides a historical
database about occurrences of reportable
diseases in the United States that
informs decision-making related to
animal health issues including emerging
animal health situations. The proposed
expansion of FAD reporting
responsibilities will enhance the ability
of Federal and State authorities to
promptly and effectively manage
reportable animal disease occurrences.
Based on our review of available
information, APHIS does not expect the
proposed rule to have a significant
economic impact on small entities. We
have prepared this initial regulatory
flexibility analysis because our
understanding of possible economic
effects of the rule on small entities is
incomplete. In the absence of apparent
significant economic impacts, we have
not identified alternatives that would
minimize such impacts.

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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
State and local officials. (See 2 CFR
chapter IV.)
Executive Order 12988
This proposed rule has been reviewed
under Executive Order 12988, Civil
Justice Reform. If this proposed rule is
adopted: (1) All State and local laws and
regulations that are in conflict with this
rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) administrative proceedings
will not be required before parties may
file suit in court challenging this rule.
Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection or recordkeeping
requirements included in this proposed
rule have been submitted for approval to
the Office of Management and Budget
(OMB). Written comments and
recommendations for the proposed
information collection should be sent
within 60 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.’’ Please send a copy of
your comments to: (1) Docket No.
APHIS–2017–0002, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238, and (2)
Clearance Officer, OCIO, USDA, room
404–W, 14th Street and Independence
Avenue SW, Washington, DC 20250. A
comment to OMB is best assured of
having its full effect if OMB receives it
within 30 days of publication of this
proposed rule.
This rule would require the
submission of ad hoc reports (for
notifiable diseases) and recurring
reports (for monitored diseases).
We are soliciting comments from the
public (as well as affected agencies)
concerning our proposed information
collection and recordkeeping
requirements. These comments will
help us:
(1) Evaluate whether the proposed
information collection is necessary for
the proper performance of our agency’s
functions, including whether the
information will have practical utility;
(2) Evaluate the accuracy of our
estimate of the burden of the proposed

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information collection, including the
validity of the methodology and
assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
information collection on those who are
to respond (such as through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submission of responses).
Estimate of burden: Public reporting
burden for this collection of information
is estimated to average 0.37362 hours
per response.
Respondents: Individuals,
laboratories, and States.
Estimated annual number of
respondents: 2,205.
Estimated annual number of
responses per respondent: 33.236.
Estimated annual number of
responses: 73,285.
Estimated total annual burden on
respondents: 27,381 hours. (Due to
averaging, the total annual burden hours
may not equal the product of the annual
number of responses multiplied by the
reporting burden per response.)
A copy of the information collection
may be viewed on the Regulations.gov
website or in our reading room. (A link
to Regulations.gov and information on
the location and hours of the reading
room are provided under the heading
ADDRESSES at the beginning of this
proposed rule.) Copies can also be
obtained from Mr. Joseph Moxey,
APHIS’ Information Collection
Coordinator, at (301) 851–2483. APHIS
will respond to any ICR-related
comments in the final rule. All
comments will also become a matter of
public record.

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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 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 proposed
rule, please contact Mr. Joseph Moxey,
APHIS’ Information Collection
Coordinator, at (301) 851–2483.
Lists of Subjects
9 CFR Part 57
Animal diseases, Reporting and
recordkeeping requirements.

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9 CFR Part 161
Reporting and recordkeeping
requirements, Veterinarians.
Accordingly, we propose to amend 9
CFR chapter I as follows:
■ 1. Part 57 is added to subchapter B to
read as follows:
PART 57—ANIMAL HEALTH
DIAGNOSTICS AND TESTING
Sec.
57.1
57.2

Definitions.
National List of Reportable Animal
Diseases.

Authority: 7 U.S.C. 8301–8317; 7 CFR
2.22, 2.80, and 371.4.
§ 57.1

Definitions.

As used in this part, the following
terms shall have the meanings set forth
in this section.
Animal and Plant Health Inspection
Service. The Animal and Plant Health
Inspection Service of the United States
Department of Agriculture (APHIS).
Animal health professional. An
individual, corporate entity, or animal
health organization with formal training
in the diagnosis or recognition of animal
diseases and/or pests of livestock.
Examples of animal health professionals
include, but are not limited to,
veterinary medical professionals,
diagnostic laboratorians, biomedical
researchers, public health officials,
animal health officials, trained
technicians, zoo personnel, and wildlife
personnel with such training.
Livestock. All farm-raised animals.
Monitored disease. A disease or
condition where occurrence is routinely
tracked by APHIS and data are used to
monitor changes in a given population
and its environment, or to report on
disease occurrence.
NLRAD. The list of monitored and
notifiable diseases required to be
reported.
NLRAD System Standards Document.
A document that provides specific
detail on the animal diseases to be
reported, standard operating
procedures, and additional background
and resources to support reporting
efforts. The document is available on
the internet at https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases.
Notifiable disease. A disease or
condition that requires immediate
notification to Federal and State
veterinary authorities. Notifiable
diseases are: (1) Emergency incidents
(foreign animal diseases, exotic vectors,
and high priority diseases), emerging
disease incidents (involving diseases,

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infections, or infestations with agents
that are unknown, newly identified, or
previously identified but
epidemiologically changed), and
regulated disease incidents (involving
diseases for which Federal regulations
already are in place).
State. Any State, the District of
Columbia, Puerto Rico, Guam, the
Northern Mariana Islands, the Virgin
Islands of the United States, and any
other territory or possession of the
United States.
United States. All of the States.
§ 57.2 National List of Reportable Animal
Diseases.

(a) National List of Reportable Animal
Diseases. A National List of Reportable
Animal Diseases (NLRAD), along with
disease reporting requirements, will be
implemented per the provisions set
forth in this section. The NLRAD will be
maintained on the APHIS website at
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/monitoring-andsurveillance/sa_disease_reporting/ct_
usda_aphis_animal_health. Copies of
the list also will be available via postal
mail or email upon request to the Center
for Epidemiology and Animal Health,
Veterinary Services, Animal and Plant
Health Inspection Service, 2150 Centre
Ave., Bldg. B, MS 2E6, Fort Collins, CO
80526. Email requests may be directed
to [email protected].
(b) List organization. Diseases and
conditions in the NLRAD are
categorized as either notifiable or
monitored.
(1) Diseases and conditions
categorized as notifiable are further
subdivided into:
(i) Emergency incidents (foreign
animal diseases, exotic vectors, and
high priority diseases);
(ii) Emerging disease incidents
(involving diseases, infections, or
infestations with agents that are
unknown, newly identified, or
previously identified but
epidemiologically changed); and
(iii) Regulated disease incidents
(involving diseases for which Federal
regulations already are in place).
(2) Diseases and conditions
categorized as monitored are diseases
where occurrence is routinely tracked
by APHIS and data are used to monitor
changes in a given population and its
environment, or to report on disease
occurrence.
(c) Updates and edits. Changes to the
NLRAD will be announced via the
publication of a notice in the Federal
Register. Updates and edits to the
NLRAD will be considered when:
(1) An emerging disease is identified.
(2) Changes are made to the World
Organization for Animal Health (OIE)-

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Listed diseases, infections, and
infestations.
(3) Changes are made in Veterinary
Services (VS) regulations.
(4) Changes are made on the National
Veterinary Stockpile (NVS) list, USDA
Select Agents and Toxins List, or
Centers for Disease Control and
Prevention (CDC) Category A, B, or C
Bioterrorism Agents/Diseases list.
(5) Changes or additions are requested
by stakeholders. Stakeholders must
submit change requests in writing via
postal mail or email using the contact
information provided in paragraph (a) of
this section. Written requests must
include a justification for the proposed
change. Examples of justifications can
be found in the NLRAD System
Standards Document, available on the
APHIS website at https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases.
(d) Reporting. The following reporting
procedures will be required:
(1) Notifiable diseases. Any animal
health professional with knowledge of
occurrence or suspected occurrence of
an animal disease, disease agent, or
condition listed as notifiable in the
NLRAD must immediately report such
identification or suspicion to both
APHIS and the State where the livestock
is located. Reporting to APHIS may be
accomplished as described on the
NLRAD website available at: https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases, or by
contacting a local APHIS office.1
Reporting to the State should be to the
State animal health official listed at
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/monitoring-andsurveillance/sa_disease_reporting/ct_
usda_aphis_animal_health for the State
in question.
(2) Monitored diseases. (i)
Laboratories must report occurrence
information of confirmed cases of an
animal disease or condition listed as
monitored in the NLRAD on a monthly
basis to the State where the animal is
located by contacting the State animal
health official listed at https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/monitoring-andsurveillance/sa_disease_reporting/ct_
usda_aphis_animal_health.
1 Contact information for APHIS offices can be
found on the APHIS website at https://
www.aphis.usda.gov/aphis/banner/contactus, or in
the local phone directory (listed under Animal and
Plant Health Inspection Service (APHIS), Veterinary
Services).

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(ii) States must report information of
confirmed cases of an animal disease or
condition listed as monitored in the
NLRAD on a monthly basis to APHIS
through the Designated Information
Technology System available on the
APHIS website at: https://
www.aphis.usda.gov/aphis/ourfocus/
animalhealth/monitoring-andsurveillance/sa_disease_reporting/ct_
usda_aphis_animal_health.
(3) Additional guidance. Additional
reporting information, including
background and resources to support
reporting efforts, can be found in the
NLRAD System Standards Document
available on the APHIS website at:
https://www.aphis.usda.gov/aphis/
ourfocus/animalhealth/monitoring-andsurveillance/nlrad/ct_national_list_
reportable_animal_diseases. Revisions
to the NLRAD System Standards
Document, other than updates to the
NLRAD described in paragraph (c) of
this section, will be announced to the
public as needed through the
publication of a notice in the Federal
Register. The notice will also provide
for a public comment period.
(4) Alternative reporting structures.
The regulations in this paragraph (d) do
not supersede any alternative reporting
structure that APHIS may require
through issuance of a general regulation
or Federal Order.
PART 161—REQUIREMENTS AND
STANDARDS FOR ACCREDITED
VETERINARIANS AND SUSPENSION
OR REVOCATION OF SUCH
ACCREDITATION
2. The authority for part 161
continues to read as follows:

■

Authority: 7 U.S.C. 8301–8317; 15 U.S.C.
1828; 7 CFR 2.22, 2.80, and 371.4.

3. In § 161.4, paragraph (f) is revised
to read as follows:

■

§ 161.4 Standards for accredited
veterinarian duties.

*

*
*
*
*
(f) An accredited veterinarian shall
immediately report all diagnosed or
suspected cases of any animal disease,
disease agent, or condition classified as
notifiable in the National List of
Reportable Animal Diseases (NLRAD) in
accordance with reporting provisions
set forth in § 57.2 of this chapter. The
NLRAD can be viewed on the APHIS
website at: https://www.aphis.usda.gov/
aphis/ourfocus/animalhealth/
monitoring-andsurveillance/sa_disease_
reporting/ct_usda_aphis_animal_health.
*
*
*
*
*

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18477

Done in Washington, DC, this 26th day of
March 2020.
Mark Davidson,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2020–06697 Filed 4–1–20; 8:45 am]
BILLING CODE 3410–34–P

NUCLEAR REGULATORY
COMMISSION
10 CFR Chapter I
[NRC–2017–0214]

Retrospective Review of
Administrative Requirements
Nuclear Regulatory
Commission.
ACTION: Request for comment; extension
of comment period.
AGENCY:

On February 4, 2020, the U.S.
Nuclear Regulatory Commission (NRC)
requested input from its licensees and
members of the public to identify
outdated or duplicative administrative
requirements that may be eliminated
without an adverse effect on public
health or safety, common defense and
security, protection of the environment,
or regulatory efficiency and
effectiveness. The public comment
period originally was scheduled to close
on April 6, 2020. The NRC has decided
to extend the public comment period to
allow more time for members of the
public to develop and submit their
comments.

SUMMARY:

The comment period for the
document published on February 4,
2020 (85 FR 6103) is extended.
Comments should be filed no later than
May 6, 2020. Comments received after
this date will be considered, if it is
practical to do so, but the NRC is able
to ensure consideration only for
comments received on or before this
date.

DATES:

You may submit comments
by any of the following methods:
• Federal Rulemaking website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2017–0214. Address
questions about NRC dockets to Carol
Gallagher; telephone: 301–415–3463;
email: [email protected]. For
technical questions contact the
individuals listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Email comments to:
[email protected]. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
ADDRESSES:

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