[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Proposed Rules]
[Pages 12955-12959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06473]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

9 CFR Part 92

[Docket No. APHIS-2017-0105]
RIN 0579-AE43


Evaluation and Recognition of the Animal Health Status of 
Compartments

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to establish standards to allow us to 
recognize compartments for animal disease status, consistent with World 
Organization for Animal Health international standards. Under this 
proposed rule, when a foreign government submits a request for 
recognition of a compartment, we would conduct a disease risk 
assessment based on a list of eight factors that closely parallel those 
we use when conducting regionalization evaluations, and we would 
provide for public notice of and comment on the risk assessment. We 
would also add provisions for imposing import restrictions and/or 
prohibitions when a compartment we have recognized as disease-free 
experiences an outbreak and for lifting those sanctions once the 
outbreak has been controlled. These proposed standards would provide a 
tool that may be used to preserve international trade when 
regionalization is not feasible.

DATES: We will consider all comments that we receive on or before June 
3, 2019.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0105.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2017-0105, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2017-
0105 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,

[[Page 12956]]

please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Dr. Lisa Rochette, Staff Officer, 
Regionalization Evaluation Services, Strategy and Policy, VS, APHIS, 
920 Main Campus Drive, Suite 200, Raleigh, NC 27606; (919) 855-7276; 
[email protected].

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in 9 CFR part 92, ``Importation of Animals and 
Animal Products; Procedures for Requesting Recognition of Regions'' 
(referred to below as the regulations), set forth the process by which 
a foreign government may request recognition of the animal health 
status of a region. These regulations require that such requests be 
accompanied by information regarding the region that will enable the 
Animal and Plant Health Inspection Service (APHIS) of the U.S. 
Department of Agriculture to evaluate the request.
    In order to conduct a valid evaluation of a region's animal health 
status and any risk that may be associated with the action requested, 
it is important that APHIS have complete and pertinent information 
regarding the region, its disease history, its animal health practices 
and capabilities, and any effect its import practices or relationship 
to adjacent regions might have on disease risk. Using information 
provided by the government of requesting country or region, information 
obtained on site visits, and publically available information, we base 
our evaluations on our assessment of the following eight factors:
     Scope of the evaluation being requested;
     Veterinary control and oversight;
     Disease history and vaccination practices;
     Livestock demographics and traceability;
     Epidemiological separation from potential sources of 
infection;
     Diagnostic laboratory capabilities;
     Surveillance practices; and
     Emergency preparedness and response.
    When regionalization is not feasible, compartmentalization is a 
tool that may be used to preserve trade. Compartmentalization is a 
procedure that a country may implement to define and manage animal 
subpopulations of distinct health status and under common biosecurity 
management within its territory, in accordance with the guidelines in 
the World Organization for Animal Health (OIE) Terrestrial Animal 
Health Code, for the purpose of disease control and international 
trade. Compartmentalization is distinct from regionalization, which 
involves the recognition of geographical zones of a country that can be 
identified and characterized by their level of risk for different 
diseases, but the two are not mutually exclusive.
    While APHIS recently established domestic compartmentalization for 
primary poultry breeders under the National Poultry Improvement Plan, 
the regulations in part 92 do not provide standards for the recognition 
of compartments in countries or regions wishing to export live animals 
or animal products to the United States. Such standards are necessary 
to enable us to use compartmentalization as another tool, along with 
regionalization, to minimize trade disruptions in the event of a 
disease outbreak. We are therefore proposing to add requirements for 
the recognition of compartments for animal disease status to the 
regulations. The proposed requirements, which would closely track the 
existing ones for recognizing regions, would include a list of eight 
factors on which we would base our evaluations of the compartments and 
would provide for a process that would allow the public to review and 
comment on our risk documentation prior to our making a final 
determination on the status of a compartment under consideration. We 
would also provide for the imposition of restrictions and/or 
prohibitions when a compartment we have recognized as disease-free 
experiences an outbreak and for their removal once the outbreak has 
been controlled.
    Adding such a process to the regulations would necessitate revising 
the current heading for 9 CFR part 92, which only covers regions. The 
revised heading would include a reference to compartments.
    The existing regulations do not define compartment. We propose to 
add a definition of compartment to Sec.  92.1 to read as follows: Any 
defined animal subpopulation contained in one or more establishments 
under a common biosecurity management system for which surveillance, 
control, and biosecurity measures have been applied with respect to a 
specific disease. The proposed definition is in keeping with the 
description of compartmentalization provided above.
    Current Sec.  92.2 contains requirements for recognition of a 
region for disease status. Paragraph (a) contains general procedures 
for a foreign government or APHIS to follow when initiating a request 
for such recognition. Paragraph (b) lists the information the 
requesting government is required to provide in order for APHIS to 
conduct the evaluation. Paragraph (c) lists the information required to 
support a request for APHIS to conduct an evaluation in order to 
recognize a foreign region as historically free of a disease. Paragraph 
(d) directs the reader to the lists maintained on the APHIS website of 
countries' and regions' disease statuses. Paragraphs (e) and (f) 
describe the process APHIS employs to allow the public to comment on 
its evaluations. Paragraph (g) states that if a region's request is 
granted, the region may still be required to submit additional 
information or allow APHIS to engage in additional information-
gathering activities.
    Since proposed Sec.  92.2 would apply to compartments as well as 
regions, we would revise the section heading and several paragraphs 
that currently refer only to regions by adding references to 
compartments as well. We would revise paragraph (a) in this manner, 
thereby indicating that the general procedures for initiating a market 
request would apply for compartments as well as for regions. We would 
also update the address to which foreign governments would submit their 
requests for recognition of regional or compartmental disease status.
    Paragraphs (b) and (c) would continue to apply only to regions. We 
are not proposing to make any substantive changes to those paragraphs. 
However, we are proposing to redesignate current paragraphs (d), (e), 
(f), and (g) as paragraphs (e), (g), (h), and (i), respectively, and 
add new paragraphs (d) and (f).
    In new paragraph (d), we are proposing to list the factors on which 
we would base our evaluation of a compartment for disease status. As is 
the case for regions, the requesting government would need to submit 
information, in English, that APHIS would use to assess the compartment 
on each factor. The proposed paragraph would also provide a hyperlink 
and a mailing address for the foreign government to use to obtain more 
detailed information regarding the specific types of data that will 
enable APHIS to most expeditiously conduct an evaluation of the 
request. The factors we would evaluate are:
     Scope of the evaluation being requested;
     Veterinary control and oversight of the compartment;
     Disease history and vaccination practices;
     Livestock or poultry commodity movement and traceability;

[[Page 12957]]

     Epidemiologic separation of the compartment from potential 
sources of infection;
     Surveillance;
     Diagnostic laboratory capabilities; and
     Emergency preparedness and response.
    With one exception, which will be discussed in detail below, these 
eight proposed factors very closely parallel the existing ones for 
recognition of regions listed in current paragraphs (b)(1) through (8). 
We would, however, specifically reference compartments in proposed 
paragraphs (d)(2) and (5), respectively, which would consist of the 
second and fifth bulleted items above.
    Current paragraph (b)(4) requires the national government(s) 
requesting an evaluation of a region for disease status to submit 
information to APHIS regarding livestock demographics and traceability 
in the region. We do not believe that by simply incorporating the 
language from that paragraph, we could necessarily obtain the 
information we need in relation to compartments. Instead, proposed 
paragraph (d)(4) would require the submission of information on 
livestock or poultry commodity movement and traceability into, within, 
and out of the compartment, paying particular attention to protocols 
that must be followed at each of these phases to allow for such 
movements. That information would aid us in determining how the 
compartment under consideration would keep its animal population 
separate from the rest of the animal population in the country or 
region within which the compartment exists. Unlike current paragraph 
(b)(4), proposed paragraph (d)(4) would not refer to livestock 
demographics, a factor that the limited scope of compartmentalization 
risk assessments would render largely irrelevant. In most cases, the 
compartment we would be evaluating would comprise a set of vertically 
integrated farm(s), feedmill(s), and other production sites (e.g., 
hatcheries) encompassing one species, along with associated commercial 
outputs managed by one company. The compartmentalized animal 
subpopulation/species would be distinct from the livestock population 
outside of the compartment.
    In new paragraph (f), we propose to state that a list of countries 
that have requested an APHIS compartmentalization evaluation, and a 
description of the requested compartment(s), would be available in a 
document posted to: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request. This proposed paragraph is similar to 
current paragraph (d) (which would be redesignated as paragraph (e)), 
which pertains to the information we would make available to the public 
on regions requesting a status evaluation.
    Current paragraph (g) (which would be redesignated as paragraph 
(i)) states that if a region is granted animal health status under the 
provisions of this section, that region may be required to submit 
additional information pertaining to its animal health status or allow 
APHIS to conduct additional information-gathering activities in order 
for that region to maintain its animal health status. Under this 
proposed rule, the provision would apply to compartments as well; 
therefore, we would revise the paragraph by adding references to 
compartments where appropriate.
    Current Sec.  94.4 contains requirements for interim disease status 
designations, i.e., the imposition of importation restrictions and/or 
prohibitions when there is a disease outbreak in a region we have 
previously recognized as free of a disease, for a subsequent 
reassessment by APHIS of the region's status, and for the 
reestablishment of its previous disease-free status when the outbreak 
has been controlled and the prohibitions or restrictions are no longer 
needed. As indicated in Sec.  92.4(a), when such an outbreak occurs, 
APHIS will take immediate action to prohibit or restrict imports from 
the entire region or, if appropriate, a portion of it, will assign an 
interim disease-status designation to the region or portion thereof, 
and will notify the public of the status change via a notice in the 
Federal Register. As stated in Sec.  92.4(b), APHIS may subsequently 
conduct a reassessment of the disease situation in the region. Prior to 
taking any action to relieve the prohibitions or restrictions we have 
imposed, we will make information regarding our reassessment of the 
region's disease status available to the public for comment via a 
notice in the Federal Register. Paragraph (c) states that based on the 
findings of our reassessment and the comments we receive on the initial 
notice, we may publish a second notice in the Federal Register 
announcing our determination or, if needed, another document in the 
Federal Register requesting additional comments.
    Since the proposed requirements in Sec.  92.4 would apply to entire 
regions, portions of regions, and compartments, we would add references 
to compartments, as appropriate, throughout the section.

Miscellaneous

    In current Sec.  92.2 paragraphs (a), (b), (c), and (d), there are 
mailing addresses and/or URLs that are outdated. We would update that 
information. In addition, as explained previously, our proposed 
additions of new paragraphs (d) and (f) to Sec.  92.2 necessitate the 
redesignation of current paragraphs (d), (e), (f), and (g) as 
paragraphs (e), (g), (h), and (i), respectively. In newly redesignated 
paragraph (e), we would make an editorial change to eliminate possible 
confusion about who may make a request for evaluation of disease 
status. In newly redesignated paragraph (g), we would revise references 
to other paragraphs in Sec.  92.2 to reflect the redesignations.

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. 
Further, APHIS considers this rule to be a deregulatory action under 
Executive Order 13771 as the action is intended to minimize trade 
disruptions and could thereby provide benefits to producers and 
consumers.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov website (see ADDRESSES above for instructions 
for accessing Regulations.gov).
    We are proposing to establish standards to allow us to recognize 
compartments for animal disease status, consistent with OIE 
international standards. This proposed rule would add 
compartmentalization as an option for evaluating disease status, but 
would not propose a specific implementation of this option.
    The potential economic effects of imports based on a 
compartmentalization approach would depend on the disease status 
evaluation specific to the particular commodity and facility and the 
expected volume of the commodity that would be imported under this 
option. Under this proposed rule, we would perform a risk analysis

[[Page 12958]]

to evaluate the animal health status of a compartment, as we currently 
do when evaluating regions. If after conducting the evaluation, we 
deemed the risk of importing animals or animal products from that 
compartment in accordance with the regulations to be acceptable, we 
would publish a notice in the Federal Register announcing the 
availability of the risk documentation for public review and comment.
    Because this proposed rule would not include the implementation of 
any specific compartmentalization decisions, there are no costs or cost 
savings that would directly result from this action. Gains could be 
realized when compartmentalization is implemented, however, because it 
may serve as a means of minimizing trade disruptions.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

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 inconsistent 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 
requirements included in this proposed rule have already been approved 
by the Office of Management and Budget under control number 0579-0040.

E-Government Act Compliance

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

List of Subjects in 9 CFR Part 92

    Animal diseases, Imports, Incorporation by reference, Livestock, 
Poultry and poultry products, Region, Reporting and recordkeeping 
requirements.

    Accordingly, we propose to amend 9 CFR part 92 as follows:

PART 92--IMPORTATION OF ANIMALS AND ANIMAL PRODUCTS: PROCEDURES FOR 
REQUESTING RECOGNITION OF REGIONS AND COMPARTMENTS

0
1. The authority citation for part 92 continues to read as follows:

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

0
2. The heading of part 92 is revised to read as set forth above.
0
3. Section 92.1 is amended by adding in alphabetical order a definition 
of Compartment to read as follows:


Sec.  92.1  Definitions.

* * * * *

Compartment. Any defined animal subpopulation contained in one or more 
establishments under a common biosecurity management system for which 
surveillance, control, and biosecurity measures have been applied with 
respect to a specific disease.
* * * * *
0
4. Section 92.2 is revised to read as follows:


Sec.  92.2   Application for recognition of the animal health status of 
a region or a compartment.

    (a) The representative of the national government(s) of any country 
or countries who has the authority to make such a request may request 
that APHIS recognize the animal health status of a region or a 
compartment.\1\ Such requests must be made in English and must be sent 
to the Administrator, c/o Strategy and Policy, VS, APHIS, 4700 River 
Road, Unit 38, Riverdale, MD 20737-1231. (Where possible, include a 
copy of the request and accompanying information in electronic format.)
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    \1\ Additionally, APHIS may choose to initiate an evaluation of 
the animal health status of a foreign region or compartment on its 
own initiative. In such cases, APHIS will follow the same evaluation 
and notification procedures set forth in this section.
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    (b) Requests for recognition of the animal health status of a 
region, other than requests submitted in accordance with paragraph (c) 
of this section, must include, in English, the following information 
about the region. More detailed information regarding the specific 
types of information that will enable APHIS to most expeditiously 
conduct an evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by 
contacting the National Director, Regionalization Evaluation Services, 
VS, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight.
    (3) Disease history and vaccination practices.
    (4) Livestock demographics and traceability.
    (5) Epidemiological separation from potential sources of infection.
    (6) Surveillance.
    (7) Diagnostic laboratory capabilities.
    (8) Emergency preparedness and response.
    (c) Requests for recognition that a region is historically free of 
a disease based on the amount of time that has elapsed since the 
disease last occurred in a region, if it has ever occurred, must 
include, in English, the following information about the region. More 
detailed information regarding the specific types of information that 
will enable APHIS to most expeditiously conduct an evaluation of the 
request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the National Director, 
Regionalization Evaluation Services, VS, APHIS, 4700 River Road, Unit 
38, Riverdale, MD 20737. For a region to be considered historically 
free of a disease, the disease must not have been reported in domestic 
livestock for at least the past 25 years and must not have been 
reported in wildlife for at least the past 10 years.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight.
    (3) Disease history and vaccination practices.
    (4) Disease notification.
    (5) Disease detection.
    (6) Barriers to disease introduction.
    (d) Requests for recognition of the animal health status of a 
compartment must include, in English, the following information about 
the compartment. More detailed information regarding the specific types 
of information that will enable APHIS to most expeditiously conduct an 
evaluation of the request is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request or by contacting the 
National Director,

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Regionalization Evaluation Services, VS, APHIS, 4700 River Road, Unit 
38, Riverdale, MD 20737.
    (1) Scope of the evaluation being requested.
    (2) Veterinary control and oversight of the compartment.
    (3) Disease history and vaccination practices.
    (4) Livestock or poultry commodity movement and traceability.
    (5) Epidemiologic separation of the compartment from potential 
sources of infection.
    (6) Surveillance.
    (7) Diagnostic laboratory capabilities.
    (8) Emergency preparedness and response.
    (e) A list of those regions for which an APHIS recognition of their 
animal health status has been requested, the disease(s) under 
evaluation, and, if available, the animal(s) or product(s) the region 
wishes to export, is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.
    (f) A list of countries that have requested an APHIS 
compartmentalization evaluation, and a description of the requested 
compartment is available at: https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.
    (g) If, after review and evaluation of the information submitted in 
accordance with paragraph (b), (c), or (d) of this section, APHIS 
believes the request can be safely granted, APHIS will indicate its 
intent and make its evaluation available for public comment through a 
document published in the Federal Register.
    (h) APHIS will provide a period of time during which the public may 
comment on its evaluation. During the comment period, the public will 
have access to the information upon which APHIS based its evaluation, 
as well as the evaluation itself. Once APHIS has reviewed all comments 
received, it will make a final determination regarding the request and 
will publish that determination in the Federal Register.
    (i) If a region or compartment is granted animal health status 
under the provisions of this section, the representative of the 
national government(s) of any country or countries who has the 
authority to make a regionalization or compartmentalization request may 
be required to submit additional information pertaining to animal 
health status or allow APHIS to conduct additional information 
collection activities in order for that region or compartment to 
maintain its animal health status.

    (Approved by the Office of Management and Budget under control 
number 0579-0040)

0
5. Section 92.4 is revised to read as follows:


Sec.  92.4  Reestablishment of a region or compartment's disease-free 
status.

    This section applies to regions or compartments that are designated 
under this subchapter as free of a specific animal disease and then 
experience an outbreak of that disease.
    (a) Interim designation. If a region or a compartment recognized as 
free of a specified animal disease in this subchapter experiences an 
outbreak of that disease, APHIS will take immediate action to prohibit 
or restrict imports of animals and animal products from the entire 
region, a portion of that region, or the compartment. APHIS will inform 
the public as soon as possible of the prohibitions and restrictions by 
means of a notice in the Federal Register.
    (b) Reassessment of the disease situation. (1) Following removal of 
disease-free status from all or part of a region or a compartment, 
APHIS may reassess the disease situation in that region or compartment 
to determine whether it is necessary to continue the interim 
prohibitions or restrictions. In reassessing disease status, APHIS will 
take into consideration the standards of the World Organization for 
Animal Health (OIE) for reinstatement of disease-free status, as well 
as all relevant information obtained through public comments or 
collected by or submitted to APHIS through other means.
    (2) Prior to taking any action to relieve prohibitions or 
restrictions, APHIS will make information regarding its reassessment of 
the region's or compartment's disease status available to the public 
for comment. APHIS will announce the availability of this information 
by means of a notice in the Federal Register.
    (c) Determination. Based on the reassessment conducted in 
accordance with paragraph (b) of this section regarding the 
reassessment information, APHIS will take one of the following actions:
    (1) Publish a notice in the Federal Register of its decision to 
reinstate the disease-free status of the region, portion of the region, 
or compartment;
    (2) Publish a notice in the Federal Register of its decision to 
continue the prohibitions or restrictions on the imports of animals and 
animal products from that region or compartment; or
    (3) Publish another document in the Federal Register for comment.

    Done in Washington, DC, this 28th day of March 2019.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2019-06473 Filed 4-2-19; 8:45 am]
 BILLING CODE 3410-34-P