[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