[Federal Register Volume 85, Number 40 (Friday, February 28, 2020)]
[Rules and Regulations]
[Pages 11833-11836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03719]
[[Page 11833]]
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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
Establishment of Regulations for the Evaluation and Recognition
of the Animal Health Status of Compartments
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
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SUMMARY: We are establishing standards to allow us to recognize
compartments for animal disease status, consistent with World
Organization for Animal Health international standards. Under this
action, when a foreign government submits a request for recognition of
a compartment, we will conduct a compartmentalization evaluation based
on a list of factors that parallel those we use when conducting
regionalization evaluations, and will provide for public notice of and
comment on the risk assessment. We are also adding provisions for
imposing import restrictions 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 standards
for compartmentalization will provide a means for preserving
international trade when regionalization is not feasible.
DATES: Effective March 30, 2020.
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. 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 for the Animal and Plant Health
Inspection Service (APHIS) of the U.S. Department of Agriculture to
have 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.
When regionalization is not feasible, compartmentalization is a
means that may be used to preserve trade. Under compartmentalization, a
country may 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.
On April 3, 2019, we published in the Federal Register (84 FR
12955-12959, Docket No. APHIS-2017-0105) a proposal \1\ to amend the
regulations by establishing standards to allow us to recognize
compartments for animal disease status, consistent with OIE
international standards.
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\1\ To view the proposed rule, the supporting document, and the
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2017-0105.
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We solicited comments concerning our proposal for 60 days ending
June 3, 2019. We received seven comments on the proposal. They were
from a foreign government, meat and poultry trade organizations, an
organization representing poultry veterinarians, and the public. All
responses were in favor of the proposed rule, though one requested
further information regarding issues largely related to implementation
of the proposed regulations. The comments and APHIS' responses are
discussed below.
Compartment Evaluation
The commenter asked how APHIS will prioritize the
compartmentalization requests it receives.
Similar to regionalization evaluations, APHIS will evaluate
compartmentalization requests in the order they are received and
process them with the resources available.
The commenter wanted to know how long it will take for APHIS to
begin evaluating a compartmentalization request after we receive it.
As with regionalization evaluations, the timeframe to initiate and
complete a compartmentalization evaluation is subject to several
factors, including the timely submission of supporting information by
the country requesting the evaluation. Supporting information required
as part of the request is listed in Sec. 92.2(d) of this final rule.
The commenter asked how we plan to conduct compartmentalization
evaluations. Specifically, the commenter asked whether APHIS will
perform evaluations on each of the compartments proposed by the
country's national competent authority, or will APHIS instead recognize
the competent authority's evaluation and approval of compartments
presented by companies in that country.
Unlike regionalization, where the national competent authority of a
country provides oversight and programs to all entities within the
region, compartments are a function of the individual company that
controls the compartment. We anticipate a limited number of
compartments per country, and therefore expect to evaluate and approve
the national competent authority's program and all individual
compartment's controlling company and compartment components. We may
also consider developing a compartmentalization systems approach if
several compartments become approved in a country. This approach would
be dependent on our assessment of the ability of the national competent
authority of that country to administer and oversee a
compartmentalization program.
A commenter asked if APHIS will conduct site visits to evaluate
compartments and what the role of the requesting country's government
would be in the evaluation process.
As one of the requirements for our evaluation of a country's
compartmentalization program, we will conduct an initial site visit to
compartments and associated facilities such as national competent
authority offices and laboratories. We may also require additional site
visits to approve compartments that become recognized by the country's
national competent authority after our initial site visit, as well as
visits to confirm ongoing satisfactory maintenance of the
compartmentalization program or the status of an individual
compartment. We intend to collaborate with the country's national
competent authority when conducting each compartment evaluation.
The commenter asked what happens if APHIS does not approve a
country's compartment request.
As with regionalization evaluations, we will use a risk assessment
framework
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to document compartmentalization evaluations. The risk assessment draws
upon eight factors, listed in Sec. 92.2, required for a country's
national competent authority to effectively administer a
compartmentalization program, as well as technical criteria an
individual compartment must meet. If during the evaluation we find
minor deficiencies in the country's compartmentalization program or in
an individual compartment, we may allow the requesting country's
national competent authority and the company involved to correct the
deficiencies. However, if we find major deficiencies in competent
authority oversight or company implementation of a compartment, we will
not approve the program or the compartment.
If we do not approve a compartmentalization program or individual
compartment, we may not draft a formal risk evaluation document, but we
will inform the requesting country of the reasons that the program or
the compartment they have requested does not meet APHIS' criteria.
The commenter asked what the procedure would be for restoring a
compartment's status after a disease outbreak.
A livestock or poultry disease outbreak involving animals for which
the compartment was approved constitutes a major noncompliance. If a
component \2\ within a certified compartment is found to have a major
noncompliance, the entire compartment is immediately suspended. To
regain approved status, APHIS expects the country's national competent
authority to investigate the noncompliance and submit a new request for
APHIS to evaluate the compartment, as indicated in Sec. 92.4. APHIS
may elect to conduct its own evaluation, which may include a site
visit. Finally, a disease outbreak within the compartment involving
animals other than those for which the compartment is approved would be
subject to regulations and conditions for export pertaining to that
disease and the animals involved.
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\2\ A compartment is made up of at least two sites or
facilities, known as components. For example, components of a
compartment could include a feed mill, farm, hatchery, or egg depot.
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The commenter asked how APHIS will protect the privacy of business
and confidential proprietary information submitted with
compartmentalization requests, particularly considering that we intend
to publish evaluations and supporting documents for public comment.
When providing information to APHIS, submitters must indicate that
the provided information is confidential business information. Upon
intake, APHIS will review this information to ensure that the provided
information is not information that the submitter would ordinarily
disclose to the public. APHIS intends to protect confidential business
information in accordance with legal and regulatory obligations and
practice.
Finally, the commenter asked if the consultations and decisions
resulting from compartmentalization requests will be published on the
APHIS website.
A list of countries requesting an APHIS compartmentalization
evaluation and a description of each compartment requested will be
available on the APHIS website.\3\ If our evaluation of the information
submitted indicates that a request can be safely granted, we will post
our evaluation and supporting documentation for public comment on
www.regulations.gov and announce the availability of these documents
through a notice in the Federal Register. Once we review all comments
we receive on the evaluation, we will make a final determination
regarding the compartmentalization request and announce our decision in
a follow-up Federal Register notice. We will also maintain a list of
approved national competent authority compartmentalization programs on
the aforementioned APHIS website.
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\3\ The compartmentalization request list can be found at
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/export/international-standard-setting-activities-oie/regionalization/ct_reg_request.
_____________________________________-
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, without
change.
Executive Orders 12866 and 13771 and Regulatory Flexibility Act
This final 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 final rule is not an
Executive Order 13771 regulatory action because this final 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).
APHIS is establishing standards to allow us to recognize
compartments for animal disease status, consistent with World
Organization for Animal Health international standards. Like our
existing process for recognizing foreign regions for disease status,
our process will include information requirements for evaluating the
animal health status of a compartment for which a market access request
has been submitted. Under this rule, we will perform a risk assessment
to evaluate the animal health status of a compartment. If after
conducting the evaluation, we deem the risk of importing animals or
animal products from that compartment to be acceptable, we will publish
a Federal Register notice announcing the availability of the risk
documentation for public review and comment.
This rule will add compartmentalization as an option for evaluating
disease status, but not propose a specific implementation of this
option. Compartmentalization may be used when regionalization's broader
geographic requirements are more costly or simply not feasible. The
potential economic effects of imports based on a compartmentalization
approach depend on the disease status evaluation specific to the
particular commodity and facility, and the expected volume of the
commodity imported under this option.
This final rule sets forth compartmentalization as a means of
minimizing trade disruptions and delineate the information requirements
that will be used for the evaluation of compartments. There are no
costs or cost savings that will directly result from this rule. Only in
the application of compartmentalization might gains from related trade
be realized.
The APHIS Administrator has determined that this action will not
have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. If this final 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
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(44 U.S.C. 3501 et seq.), the information collection requirements
included in this final 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 final rule, please contact Mr. Joseph Moxey,
APHIS' Information Collection Coordinator, at (301) 851-2483.
List of Subjects in 9 CFR Part 92
Animal diseases, Imports, Livestock, Poultry and poultry products,
Region, Reporting and recordkeeping requirements.
Accordingly, we are amending 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 information in
paragraphs (b)(1) through (8) of this section 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 information in paragraphs (c)(1) through (6)
of this section 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 information in paragraphs
(d)(1) through (8) of this section 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,
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
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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 19th day of February 2020.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-03719 Filed 2-27-20; 8:45 am]
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