[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
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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
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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.
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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)
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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]
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