National List of Reportable Animal Diseases
| Published date | 02 April 2020 |
| Citation | 85 FR 18471 |
| Record Number | 2020-06697 |
| Section | Proposed rules |
| Court | Animal And Plant Health Inspection Service |
Federal Register, Volume 85 Issue 64 (Thursday, April 2, 2020)
[Federal Register Volume 85, Number 64 (Thursday, April 2, 2020)]
[Proposed Rules]
[Pages 18471-18477]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-06697]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
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.
========================================================================
Federal Register / Vol. 85, No. 64 / Thursday, April 2, 2020 /
Proposed Rules
[[Page 18471]]
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
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: 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.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;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/#!docketDetail;D=APHIS-2017-0002 or in our reading room, which is
located in room 1141 of the USDA South Building, 14th 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 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 Sec. 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.
---------------------------------------------------------------------------
\1\ See https://www.gao.gov/assets/680/674174.pdf.
---------------------------------------------------------------------------
In addition to the current required disease reporting from APHIS-
accredited 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
[[Page 18472]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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
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-and-surveillance/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 would
have enhanced capabilities for 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-and-surveillance/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 Sec.
57.1 would contain definitions related to animal health testing and
diagnostics. Provisions for the NLRAD and reporting requirements would
be included in proposed Sec. 57.2. We also are proposing to amend the
existing reporting requirements for APHIS-accredited veterinarians in
Sec. 161.4 to make these consistent with the new NLRAD provisions. We
will address below the proposed changes in detail.
Definitions (Sec. 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.
[[Page 18473]]
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 Sec. 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 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-and-surveillance/nlrad/ct_national_list_reportable_animal_diseases.
National List of Reportable Animal Diseases (Sec. 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 Sec. 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 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 Sec. 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-and-surveillance/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/
[[Page 18474]]
ourfocus/animalhealth/monitoring-and-surveillance/nlrad/
ct_national_list_reportable_animal_diseases for the State in question.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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/animalhealth/monitoring-and-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 (Sec. 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 Sec. 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 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).
[[Page 18475]]
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 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.
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
[[Page 18476]]
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.
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.
9 CFR Part 161
Reporting and recordkeeping requirements, Veterinarians.
Accordingly, we propose to amend 9 CFR chapter I as follows:
0
1. Part 57 is added to subchapter B to read as follows:
PART 57--ANIMAL HEALTH DIAGNOSTICS AND TESTING
Sec.
57.1 Definitions.
57.2 National List of Reportable Animal Diseases.
Authority: 7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
Sec. 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-and-surveillance/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, 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.
Sec. 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-and-surveillance/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)-
[[Page 18477]]
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-and-surveillance/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-and-surveillance/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-and-surveillance/sa_disease_reporting/ct_usda_aphis_animal_health for the State in
question.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
(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-and-surveillance/sa_disease_reporting/ct_usda_aphis_animal_health.
(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-and-surveillance/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-and-surveillance/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
0
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.
0
3. In Sec. 161.4, paragraph (f) is revised to read as follows:
Sec. 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 Sec. 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.
* * * * *
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
