Decision To Authorize the Importation of Fresh Sand Pears From Japan Into the United States, 21167-21170 [2020-08030]
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Federal Register / Vol. 85, No. 74 / Thursday, April 16, 2020 / Notices
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[FR Doc. 2020–08044 Filed 4–15–20; 8:45 am]
BILLING CODE 3410–05–P
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2019–0057]
Decision To Authorize the Importation
of Fresh Sand Pears From Japan Into
the United States
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public of
our decision to authorize importation of
sand pears from all production areas of
Japan into the United States and to
revise the conditions under which they
may be imported. Based on the findings
of a commodity import evaluation
document, which we made available to
the public for review and comment
through a previous notice, we have
concluded that the application of one or
more designated phytosanitary
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SUMMARY:
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measures will be sufficient to mitigate
the risks of introducing or disseminating
plant pests or noxious weeds via the
importation of fresh sand pears from all
production areas of Japan.
DATES: The articles covered by this
notice may be authorized for
importation after April 16, 2020.
FOR FURTHER INFORMATION CONTACT: Mr.
Tony Roman, Senior Regulatory Policy
Specialist, RCC, IRM, PHP, PPQ, APHIS,
4700 River Road Unit 133, Riverdale,
MD 20737–1236; (301) 851–2242.
SUPPLEMENTARY INFORMATION:
Under the regulations in ‘‘Subpart L—
Fruits and Vegetables’’ (7 CFR 319.56–
1 through 319.56–12, referred to below
as the regulations), the Animal and
Plant Health Inspection Service (APHIS)
prohibits or restricts the importation of
fruits and vegetables into the United
States from certain parts of the world to
prevent plant pests from being
introduced into and spread within the
United States.
Section 319.56–4 of the regulations
contains a notice-based process based
on established performance standards
for authorizing the importation of fruits
and vegetables. Paragraph (c) of that
section provides that the name and
origin of all fruits and vegetables
authorized importation into the United
States, as well as the requirements for
their importation, are listed in APHIS’
Fruits and Vegetables Import
Requirements database (FAVIR) on the
internet at https://
epermits.aphis.usda.gov/manual. It also
provides that, if the Administrator of
APHIS determines that any of the
phytosanitary measures required for the
importation of a particular fruit or
vegetable are no longer necessary to
reasonably mitigate the plant pest risk
posed by the fruit or vegetable, APHIS
will publish a notice in the Federal
Register making its pest risk analysis
and determination available for public
comment.
In accordance with that process, we
published a notice 1 in the Federal
Register on September 23, 2019 (84 FR
49709–49710, Docket No. APHIS–2019–
0057) announcing the availability, for
review and comment, of a pest list and
a commodity import evaluation
document (CIED) prepared relative to
revising the conditions for the
importation of fresh sand pears (Pyrus
pyrifolia) from Japan into the United
States. The notice proposed both to
revise the conditions for the importation
of sand pears from Japan into the United
1 To view the notice, pest list, CIED, economic
evaluation assessment, and the comments that we
received, go to https://www.regulations.gov/
#!docketDetail;D=APHIS-2019-0057.
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21167
States and to authorize their importation
from all prefectures of Japan (excluding
the Amami, Bonin, Ryukyu, Tokara, and
Volcano Islands) rather than from
certain authorized areas of production.
We noted in the CIED that no quarantine
pests have been intercepted on sand
pear at the ports of entry into the United
States since market access was granted
to Japan in 1985.
We solicited comments on the pest
list and CIED for 60 days ending on
November 22, 2019. We received five
comments by that date. They were from
State departments of agriculture, an
organization representing tree fruit
growers, and the public. The comments
that we received are discussed below by
topic.
General Comments
One commenter representing a State
government expressed concern that
there were no mitigations in the revised
requirements for importation of sand
pears from Japan other than
phytosanitary inspection.
We have determined, for the reasons
described in the CIED that accompanied
the notice, that the conditions in place
will effectively mitigate the pest risk
associated with the importation of fresh
sand pear from Japan. The commenter
did not provide any evidence suggesting
that the mitigations are not effective.
Therefore, we are not taking the action
requested by the commenter.
A commenter recommended that
APHIS deregulate the importation of
sand pear from Japan to a greater extent
than as currently proposed, adding that
many studies on which we have based
our import requirements are outdated
and do not account for advancements in
selective breeding by the National
Agriculture and Food Research
Organization of Japan. The commenter
noted that, with respect to future
breeding, marker-assisted selection for
each trait, genome-wide association
studies, and genomic selection analyses
are currently in progress. The
commenter also noted that experimental
breeding is underway in Japan to
produce disease-resistant cultivars,
some of which are being harvested for
consumption.
We acknowledge the work underway
in Japan to develop disease-resistant
varieties of sand pear. However, as the
commenter noted, much of this work is
experimental or at the research stage
and the commenter did not indicate
how widely it had been adopted within
the Japanese sand pear industry. As the
possibility still exists of pests following
the pathway of sand pears from Japan to
the United States, APHIS will continue
to require phytosanitary inspections and
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other mitigations as necessary to reduce
pest risk. Regarding the commenter’s
interest in relieving import restrictions,
we note that the changes we are making
to the import conditions lift restrictions
on areas of production in Japan and
remove the additional declaration
currently required for the phytosanitary
certificate. These changes relieve
regulatory burden by facilitating market
access for consumers of sand pear in the
United States while adequately
managing plant pest risk.
Another commenter stated that the
pests we determined to be reasonably
likely to follow the pathway should be
detected through a phytosanitary
inspection upon leaving Japan or
entering the United States, and asked if
100 percent of sand pears imported from
Japan would receive a phytosanitary
inspection upon arrival in the United
States.
Among the import requirements, all
consignments of sand pears from Japan
must be accompanied by a
phytosanitary certificate issued by the
national plant protection organization
(NPPO) of Japan and are subject to
inspection at the port of entry into the
United States. These are current
requirements that have not changed. As
we noted above, no quarantine pests
have been intercepted on sand pear at
the ports of entry into the United States
since 1985. As to the commenter’s
question about whether 100 percent of
sand pears would receive an inspection,
we are unsure as to whether the
commenter is asking if all sand pears
would receive an inspection, as opposed
to all shipments of sand pears. We note
that all shipments of sand pear from
Japan receive a phytosanitary inspection
and that we have determined this
practice to be a sufficient mitigation.
Comments Regarding the Pest List
The pest list identified nine insects
and two plant pathogens associated
with the commodity that could
potentially follow the pathway of sand
pears imported from Japan into the
United States.
Two commenters expressed concerns
about the risk potential of several pests
not included in the list of pests that
have a reasonable likelihood of
following the pathway.
One commenter stated that eriophyid
mites require microscopy for their
identification and could be missed in a
visual inspection of fruit.
Although we agree that such mites
can only be identified through
magnification, workplan requirements
for orchard fruit bagging and
postharvest washing and brushing are
effective mitigations for these pests, and
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we therefore determined that these pests
are not likely to follow the pathway of
sand pears imported from Japan into the
United States. For this reason, we see no
reason to make changes in response to
the comment.
The same commenter also raised a
concern about the pear blister canker, a
viroid, noting that if it can be
transmitted mechanically, as we
indicate in the pest list, then it could be
transferred by that means to other Pyrus
species. The commenter concluded that
expansion of the export area in Japan
should not be undertaken before this
concern is addressed.
We are making no changes in
response to the comment. Mechanical
transmission refers to transmission by
the use of tools contaminated by crop
production or grafting. For transmission
to occur, a consumer would first have to
cut an infected fruit and then cut a pear
tree with the same instrument, and do
so during a time when optimal
environmental conditions are present.
We conclude that such a scenario is
highly unlikely.
Another commenter stated that four
additional pests—Bactrocera dorsalis
(Hendel), Botryosphaeria kuwatsukai
(Hara) (syn. Guignardia pyricola),
Monilinia polystroma, and Venturia
naschicola—are likely to enter the
export pathway of sand pears from
Japan and should be named in the
operational workplan and inspection
protocols so that growers and packers in
Japan, inspectors in Japan, and APHIS
inspection personnel can identify and
remove them accordingly.
APHIS developed the pest list based
on the scientific literature, port-of-entry
pest interception data, and information
provided by the Government of Japan. It
also follows the International Plant
Protection Convention (IPPC) guidance
for conducting pest risk analyses for
quarantine pests. Our conclusions do
not indicate that the four additional
pests named by the commenter are
likely to enter the export pathway of
sand pears imported from Japan, and
accordingly we are not adding the pests
to the pest list. However, we have
responded to the commenter’s concerns,
included below, for each of the four
pests.
The commenter stated that as the
oriental fruit fly, Bactrocera dorsalis
(Hendel), is a pest of concern for
movement of apples in international
trade, it should be considered in pear as
well. The commenter advised that
mitigation measures included in the
1998 operational workplan should be
maintained against oriental fruit fly and
that it should be added to the list of
quarantine pests.
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As indicated in the CABI Invasive
Species Compendium,2 B. dorsalis has
been eradicated from Japan.
Consequently, we have no scientific
reason to conclude that the pest is likely
to enter the export pathway of sand
pears shipped to the United States from
Japan under the revised conditions.
The same commenter noted that
Botryosphaeria kuwatsukai (Hara) has
been reported to cause ring rot of fruit
in China and Japan and can be observed
on harvested parts.
As we noted above, our conclusions
do not indicate that B. kuwatsukai is
likely to enter the export pathway of
sand pears imported from Japan. While
the pathogen has been found on apples
in China, as noted by the commenter,
we have no evidence to support the
contention that this disease could affect
sand pear fruit in the field. Moreover,
no harvested parts of Pyrus pyrifolia
other than the fruit are authorized for
import into the United States from
Japan.
The commenter also stated that
Monilinia polystroma is reported on
Pyrus spp. in Japan and provided a
citation as evidence (van Leewen et al.
2002). The commenter asked if APHIS
reviewed this citation as part of the pest
risk assessment.
While APHIS has reviewed the
citation noted by the commenter, we
found no evidence that this fungus is
associated with the particular species of
pear (Pyrus pyrifolia) that is the subject
of the pest list.
The commenter disagreed with our
statement that V. nashicola and M.
fructigena can be found visually during
the phytosanitary certification
inspection when seasonal growing
conditions are conducive for infection.
The commenter noted that fruit infected
with these fungi can appear normal, as
latent infections under the calices of
fruit and on stems are not easily visible
upon inspection and must be identified
microscopically. The commenter added
that these latent infections can be
prevalent depending upon climate and
growing season and expressed concern
that they may escape detection by
packers and government inspectors.
Another commenter concurred with
respect to M. fructigena, noting that we
prescribed no treatment for the
pathogen and that symptomatic fruit
would not be easily visible at the time
of packing.
While the possibility exists that latent
infections of these fungi may escape
detection during inspections, we have
determined that the likelihood of
establishment of the disease via fruit is
2 https://www.cabi.org/isc/datasheet/17685.
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low. Should commercial shipments of
sand pear latently infected with these
fungi escape detection, the fruit would
still need to be deposited in an orchard
with conditions adequate to allow the
fungus to grow and sporulate. We
consider such a confluence of
conditions to be highly unlikely to
occur. Moreover, under the systems
approach already in place for export of
sand pears from Japan there have been
no significant pest interceptions; the
same measures will be in place for fruit
from the approved new growing areas in
Japan.
Commenters also noted potential risks
regarding pests that we included in the
list of pests likely to follow the export
pathway and suggested that additional
mitigations are warranted.
A commenter expressed concern
about two pseudococcidae included in
the pest list, Crisicoccus matsumotoi
(Siraiwa) and Planococcus kraunhiae
(Kuwana). The commenter stated that
pseudococcidae, or mealybugs, are
strictly regulated in foreign agricultural
trade, and that a potential risk exists of
mealybug eggs, nymphs, or adult
females going undetected in sheltered
areas on imported fruit. The commenter
noted that because mealybugs have a
protective coating, routine
packinghouse procedures may not
remove all mealybugs from fruit and
cited a study showing that infested
apples can retain mealybugs,
particularly eggs, on stems after washing
and brushing. Finally, the commenter
added that mealybugs can survive cold
storage and transport.
We note that, in addition to visual
inspection, orchard fruit bagging is an
effective mitigation for mealybugs and is
a requirement in the current operational
workplan for sand pear from Japan.
Another commenter reviewed the list
of pests that we determined to have a
reasonable likelihood of following the
pathway of sand pears imported from
Japan to the United States. The
commenter stated that three of these
pests—peach fruit moth, yellow peach
moth, and Manchurian fruit moth—are
of special concern because they are
fruit-borers, allowing them to move in
fruit consignments and making them
hard to detect. One commenter
recommended that APHIS require fruit
bagging as a mitigation measure against
fruit-borers.
As noted above, we require orchard
fruit bagging in the operational
workplan for sand pear from Japan.
Fruit bagging effectively prevents boring
insects from boring into the fruit.
A commenter raised a concern about
the introduction into the United States
of Alternaria gaisen via imports of sand
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pear from Japan, citing evidence of its
interception in imports to the United
States and Australia. The commenter
noted that this fungal disease invades
young fruit via lenticels and shows as a
black speck on brown fruit, making it
hard to detect visually.
While it is possible that signs of
Alternaria gaisen may go undetected
during inspections, the likelihood of the
disease becoming established in the
United States through the movement of
sand pear fruit is low. As with M.
fructigena and V. nashicola, discussed
above, shipped fruit infected with A.
gaisen would have to be exposed to an
orchard under conditions optimal for
fungal growth and sporulation, which as
we noted with the other fungi is an
unlikely situation. Moreover, under the
systems approach already in place for
export of sand pears from Japan, there
have been no interceptions of this
fungus, and the same fungus mitigation
measures will be in place for the new
growing areas in Japan approved to
export sand pear to the United States.
Workplan
One commenter noted that the 1998
workplan measures for sand pear
exports from Japan to the United States
continue to be followed, even though an
export conditions document for fresh
sand pear dated August 2007 omits
many of the mitigations in the
workplan. The commenter
recommended that we continue to use
the workplan measures with the
addition of seasonal assessment for
fungi and scab.
The operational workplan for exports
of sand pears from Japan to the United
States has been revised to include the
revised pest list. We have also ensured
that the necessary mitigations listed in
the 1998 workplan are included in the
revised workplan to address quarantine
pests and diseases of concern. The 2007
export conditions document cited by the
commenter was used by exporters,
packinghouses, and NPPO officials of
Japan as a reference document only.
Growers, inspectors, and other involved
parties are required to implement
requirements in the operational
workplan and meet the conditions
described before sand pears can be
shipped.
The same commenter recommended
that specific weather and seasonal
guidelines be considered with respect to
mitigating fungi (including scab)
infections of fruit. The commenter noted
that such infections vary year-to-year
and are affected by seasonal rainfall and
humidity. Accordingly, the commenter
suggested that APHIS add requirements
to the operational workplan for orchards
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21169
to assess weather potential for fungi
(including scab) in a given season and
to assess the fruit for fungi and scab
symptoms after an appropriate
incubation period has passed. The
commenter stated that APHIS could
decide at that time whether to allow the
block to be part of an export program
rather than using inspection of packed
fruit.
Scab was not reported as of
quarantine concern for sand pears from
Japan in the updated pests list. The
mitigation measures already in place
show efficacy in mitigating fungi
(including scab) diseases throughout all
seasons of sand pear production in
Japan and should continue to be equally
efficacious with respect to our proposal
to allow export of sand pears from
additional growing areas in Japan. For
this reason, we are making no changes
in response to the commenter.
Site Visits
One commenter stated that after
completion of the operational workplan,
APHIS should conduct a site visit to
regions in Japan to confirm the
operational viability of the mitigation
measures.
We are making no changes in
response to the commenter. In
December 2019, APHIS reached an
agreement with the NPPO of Japan
regarding details of the systems
approach in an operational workplan.
The NPPO of Japan is obligated to fulfill
its responsibilities under the systems
approach as a signatory to the IPPC. We
have determined that it is not necessary
for us to monitor program activities on
site unless we have reason to believe
that such activities may not be
adequately mitigating pest risks. Thus,
we do not plan to make periodic site
visits. This is consistent with our
practice in other import programs. We
will, however, provide program
oversight by conducting audits if
quarantine pests are intercepted or as
otherwise warranted. By conducting
joint orchard audit inspections with the
NPPO of Japan, APHIS reserves the right
to verify if the growing conditions of the
production areas have been satisfied.
Therefore, in accordance with
§ 319.56–4(c)(4)(ii) of the regulations,
we are announcing our decision to
revise the requirements for the
importation of fresh sand pears from
Japan into the United States. The
revised conditions are as follows:
• All sand pears must be bagged on
trees to exclude pests in accordance
with the operational workplan.
• The sand pears must be
accompanied by a phytosanitary
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certificate (PC) issued by the NPPO of
Japan.3
• The sand pears are subject to
inspection at the port of entry into the
United States.
• Only commercial consignments of
Japanese sand pears may be imported
into the United States.
• The sand pears must be imported
under permit.
These revised conditions will be
listed in the Fruits and Vegetables
Import Requirements
database (available at https://
epermits.aphis.usda.gov/manual). In
addition to these specific measures,
fresh sand pears from Japan will be
subject to the general requirements
listed in § 319.56–3 that are applicable
to the importation of all fruits and
vegetables.
Paperwork Reduction Act
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), the reporting and recordkeeping
requirements included in this notice are
covered under the Office of
Management and Budget control
number 0579–0049.
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 notice, please contact Mr. Joseph
Moxey, APHIS’ Information Collection
Coordinator, at (301) 851–2483.
Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this action as not a major
rule, as defined by 5 U.S.C. 804(2).
Authority: 7 U.S.C. 1633, 7701–7772, and
7781–7786; 21 U.S.C. 136 and 136a; 7 CFR
2.22, 2.80, and 371.3.
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Done in Washington, DC, this 1st day of
April 2020.
Michael Watson,
Acting Administrator, Animal and Plant
Health Inspection Service.
[FR Doc. 2020–08030 Filed 4–15–20; 8:45 am]
BILLING CODE 3410–34–P
3 We note that sand pears from Japan may
continue to be imported into Hawaii under permit,
and subject to inspection in Hawaii, without any
further phytosanitary requirements.
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection
Service
[Docket No. APHIS–2019–0084]
Agrivida, Inc.; Availability of a Petition
for Determination of Nonregulated
Status for Maize Genetically
Engineered for the Production of
Phytase Enzyme
Animal and Plant Health
Inspection Service, USDA.
ACTION: Notice.
AGENCY:
We are advising the public
that the Animal and Plant Health
Inspection Service (APHIS) has received
a petition from Agrivida, Inc. (Agrivida)
seeking a determination of nonregulated
status for maize designated as Maize
Event PY203, which has been
genetically engineered for the
production of phytase enzyme. The
petition has been submitted in
accordance with our regulations
concerning the introduction of certain
genetically engineered organisms and
products. We are making the Agrivida
petition available for review and
comment to help us identify potential
issues and impacts that APHIS should
be considering in our evaluation of the
petition.
DATES: We will consider all comments
that we receive on or before June 15,
2020.
SUMMARY:
You may submit comments
by either of the following methods:
• Federal eRulemaking Portal: Go to
https://www.regulations.gov/
#!docketDetail;D=APHIS-2019-0084.
• Postal Mail/Commercial Delivery:
Send your comment to Docket No.
APHIS–2019–0084, Regulatory Analysis
and Development, PPD, APHIS, Station
3A–03.8, 4700 River Road Unit 118,
Riverdale, MD 20737–1238.
The petition and any comments we
receive on this docket may be viewed at
https://www.regulations.gov/
#!docketDetail;D=APHIS-2019-0084 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) 7997039
before coming.
The petition is also available on the
APHIS website at: https://
www.aphis.usda.gov/aphis/ourfocus/
biotechnology/permits-notificationspetitions/petitions/petition-status under
APHIS petition 19–176–01p.
ADDRESSES:
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Ms.
Cindy Eck, Biotechnology Regulatory
Services, APHIS, 4700 River Road Unit
147, Riverdale, MD 20737–1236; (301)
851–3892, email: cynthia.a.eck@
aphis.usda.gov.
FOR FURTHER INFORMATION CONTACT:
Under the
authority of the plant pest provisions of
the Plant Protection Act (7 U.S.C. 7701
et seq.), the regulations in 7 CFR part
340, ‘‘Introduction of Organisms and
Products Altered or Produced Through
Genetic Engineering Which Are Plant
Pests or Which There Is Reason to
Believe Are Plant Pests,’’ regulate,
among other things, the introduction
(importation, interstate movement, or
release into the environment) of
organisms and products altered or
produced through genetic engineering
that are plant pests or that there is
reason to believe are plant pests. Such
genetically engineered (GE) organisms
and products are considered ‘‘regulated
articles.’’
The regulations in § 340.6(a) provide
that any person may submit a petition
to the Animal and Plant Health
Inspection Service (APHIS) seeking a
determination that an article should not
be regulated under 7 CFR part 340.
Paragraphs (b) and (c) of § 340.6
describe the form that a petition for a
determination of nonregulated status
must take and the information that must
be included in the petition.
APHIS has received a petition (APHIS
Petition Number 19–176–01p) from
Agrivida, Inc. (Agrivida) seeking a
determination of nonregulated status for
maize designated as Maize Event PY203,
which has been genetically engineered
for the production of phytase enzyme.
The Agrivida petition states that this
maize is unlikely to pose a plant pest
risk and, therefore, should not be a
regulated article under APHIS’
regulations in 7 CFR part 340.
As described in the petition, Maize
Event PY203 was grown at six locations
across the Midwestern United States
including sites in Ohio, Indiana, Iowa,
and Nebraska and at two locations in
Argentina. Agronomic characteristics of
Maize Event PY203 and near isogenic
non-transgenic control plants grown at
these locations were assessed
throughout the life cycle of the plants.
These and other data are used by APHIS
to determine if the new variety poses a
plant pest risk.
The agronomic performance and
phenotypic data generated demonstrate
that the genetic modifications
introduced into Maize Event PY203 did
not have any unintended effects on seed
germination, agronomic characteristics,
or yield. These data support the
SUPPLEMENTARY INFORMATION:
E:\FR\FM\16APN1.SGM
16APN1
]]>Agencies
[Federal Register Volume 85, Number 74 (Thursday, April 16, 2020)]
[Notices]
[Pages 21167-21170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-08030]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2019-0057]
Decision To Authorize the Importation of Fresh Sand Pears From
Japan Into the United States
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice.
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SUMMARY: We are advising the public of our decision to authorize
importation of sand pears from all production areas of Japan into the
United States and to revise the conditions under which they may be
imported. Based on the findings of a commodity import evaluation
document, which we made available to the public for review and comment
through a previous notice, we have concluded that the application of
one or more designated phytosanitary measures will be sufficient to
mitigate the risks of introducing or disseminating plant pests or
noxious weeds via the importation of fresh sand pears from all
production areas of Japan.
DATES: The articles covered by this notice may be authorized for
importation after April 16, 2020.
FOR FURTHER INFORMATION CONTACT: Mr. Tony Roman, Senior Regulatory
Policy Specialist, RCC, IRM, PHP, PPQ, APHIS, 4700 River Road Unit 133,
Riverdale, MD 20737-1236; (301) 851-2242.
SUPPLEMENTARY INFORMATION:
Under the regulations in ``Subpart L--Fruits and Vegetables'' (7
CFR 319.56-1 through 319.56-12, referred to below as the regulations),
the Animal and Plant Health Inspection Service (APHIS) prohibits or
restricts the importation of fruits and vegetables into the United
States from certain parts of the world to prevent plant pests from
being introduced into and spread within the United States.
Section 319.56-4 of the regulations contains a notice-based process
based on established performance standards for authorizing the
importation of fruits and vegetables. Paragraph (c) of that section
provides that the name and origin of all fruits and vegetables
authorized importation into the United States, as well as the
requirements for their importation, are listed in APHIS' Fruits and
Vegetables Import Requirements database (FAVIR) on the internet at
https://epermits.aphis.usda.gov/manual. It also provides that, if the
Administrator of APHIS determines that any of the phytosanitary
measures required for the importation of a particular fruit or
vegetable are no longer necessary to reasonably mitigate the plant pest
risk posed by the fruit or vegetable, APHIS will publish a notice in
the Federal Register making its pest risk analysis and determination
available for public comment.
In accordance with that process, we published a notice \1\ in the
Federal Register on September 23, 2019 (84 FR 49709-49710, Docket No.
APHIS-2019-0057) announcing the availability, for review and comment,
of a pest list and a commodity import evaluation document (CIED)
prepared relative to revising the conditions for the importation of
fresh sand pears (Pyrus pyrifolia) from Japan into the United States.
The notice proposed both to revise the conditions for the importation
of sand pears from Japan into the United States and to authorize their
importation from all prefectures of Japan (excluding the Amami, Bonin,
Ryukyu, Tokara, and Volcano Islands) rather than from certain
authorized areas of production. We noted in the CIED that no quarantine
pests have been intercepted on sand pear at the ports of entry into the
United States since market access was granted to Japan in 1985.
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\1\ To view the notice, pest list, CIED, economic evaluation
assessment, and the comments that we received, go to https://www.regulations.gov/#!docketDetail;D=APHIS-2019-0057.
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We solicited comments on the pest list and CIED for 60 days ending
on November 22, 2019. We received five comments by that date. They were
from State departments of agriculture, an organization representing
tree fruit growers, and the public. The comments that we received are
discussed below by topic.
General Comments
One commenter representing a State government expressed concern
that there were no mitigations in the revised requirements for
importation of sand pears from Japan other than phytosanitary
inspection.
We have determined, for the reasons described in the CIED that
accompanied the notice, that the conditions in place will effectively
mitigate the pest risk associated with the importation of fresh sand
pear from Japan. The commenter did not provide any evidence suggesting
that the mitigations are not effective. Therefore, we are not taking
the action requested by the commenter.
A commenter recommended that APHIS deregulate the importation of
sand pear from Japan to a greater extent than as currently proposed,
adding that many studies on which we have based our import requirements
are outdated and do not account for advancements in selective breeding
by the National Agriculture and Food Research Organization of Japan.
The commenter noted that, with respect to future breeding, marker-
assisted selection for each trait, genome-wide association studies, and
genomic selection analyses are currently in progress. The commenter
also noted that experimental breeding is underway in Japan to produce
disease-resistant cultivars, some of which are being harvested for
consumption.
We acknowledge the work underway in Japan to develop disease-
resistant varieties of sand pear. However, as the commenter noted, much
of this work is experimental or at the research stage and the commenter
did not indicate how widely it had been adopted within the Japanese
sand pear industry. As the possibility still exists of pests following
the pathway of sand pears from Japan to the United States, APHIS will
continue to require phytosanitary inspections and
[[Page 21168]]
other mitigations as necessary to reduce pest risk. Regarding the
commenter's interest in relieving import restrictions, we note that the
changes we are making to the import conditions lift restrictions on
areas of production in Japan and remove the additional declaration
currently required for the phytosanitary certificate. These changes
relieve regulatory burden by facilitating market access for consumers
of sand pear in the United States while adequately managing plant pest
risk.
Another commenter stated that the pests we determined to be
reasonably likely to follow the pathway should be detected through a
phytosanitary inspection upon leaving Japan or entering the United
States, and asked if 100 percent of sand pears imported from Japan
would receive a phytosanitary inspection upon arrival in the United
States.
Among the import requirements, all consignments of sand pears from
Japan must be accompanied by a phytosanitary certificate issued by the
national plant protection organization (NPPO) of Japan and are subject
to inspection at the port of entry into the United States. These are
current requirements that have not changed. As we noted above, no
quarantine pests have been intercepted on sand pear at the ports of
entry into the United States since 1985. As to the commenter's question
about whether 100 percent of sand pears would receive an inspection, we
are unsure as to whether the commenter is asking if all sand pears
would receive an inspection, as opposed to all shipments of sand pears.
We note that all shipments of sand pear from Japan receive a
phytosanitary inspection and that we have determined this practice to
be a sufficient mitigation.
Comments Regarding the Pest List
The pest list identified nine insects and two plant pathogens
associated with the commodity that could potentially follow the pathway
of sand pears imported from Japan into the United States.
Two commenters expressed concerns about the risk potential of
several pests not included in the list of pests that have a reasonable
likelihood of following the pathway.
One commenter stated that eriophyid mites require microscopy for
their identification and could be missed in a visual inspection of
fruit.
Although we agree that such mites can only be identified through
magnification, workplan requirements for orchard fruit bagging and
postharvest washing and brushing are effective mitigations for these
pests, and we therefore determined that these pests are not likely to
follow the pathway of sand pears imported from Japan into the United
States. For this reason, we see no reason to make changes in response
to the comment.
The same commenter also raised a concern about the pear blister
canker, a viroid, noting that if it can be transmitted mechanically, as
we indicate in the pest list, then it could be transferred by that
means to other Pyrus species. The commenter concluded that expansion of
the export area in Japan should not be undertaken before this concern
is addressed.
We are making no changes in response to the comment. Mechanical
transmission refers to transmission by the use of tools contaminated by
crop production or grafting. For transmission to occur, a consumer
would first have to cut an infected fruit and then cut a pear tree with
the same instrument, and do so during a time when optimal environmental
conditions are present. We conclude that such a scenario is highly
unlikely.
Another commenter stated that four additional pests--Bactrocera
dorsalis (Hendel), Botryosphaeria kuwatsukai (Hara) (syn. Guignardia
pyricola), Monilinia polystroma, and Venturia naschicola--are likely to
enter the export pathway of sand pears from Japan and should be named
in the operational workplan and inspection protocols so that growers
and packers in Japan, inspectors in Japan, and APHIS inspection
personnel can identify and remove them accordingly.
APHIS developed the pest list based on the scientific literature,
port-of-entry pest interception data, and information provided by the
Government of Japan. It also follows the International Plant Protection
Convention (IPPC) guidance for conducting pest risk analyses for
quarantine pests. Our conclusions do not indicate that the four
additional pests named by the commenter are likely to enter the export
pathway of sand pears imported from Japan, and accordingly we are not
adding the pests to the pest list. However, we have responded to the
commenter's concerns, included below, for each of the four pests.
The commenter stated that as the oriental fruit fly, Bactrocera
dorsalis (Hendel), is a pest of concern for movement of apples in
international trade, it should be considered in pear as well. The
commenter advised that mitigation measures included in the 1998
operational workplan should be maintained against oriental fruit fly
and that it should be added to the list of quarantine pests.
As indicated in the CABI Invasive Species Compendium,\2\ B.
dorsalis has been eradicated from Japan. Consequently, we have no
scientific reason to conclude that the pest is likely to enter the
export pathway of sand pears shipped to the United States from Japan
under the revised conditions.
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\2\ https://www.cabi.org/isc/datasheet/17685.
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The same commenter noted that Botryosphaeria kuwatsukai (Hara) has
been reported to cause ring rot of fruit in China and Japan and can be
observed on harvested parts.
As we noted above, our conclusions do not indicate that B.
kuwatsukai is likely to enter the export pathway of sand pears imported
from Japan. While the pathogen has been found on apples in China, as
noted by the commenter, we have no evidence to support the contention
that this disease could affect sand pear fruit in the field. Moreover,
no harvested parts of Pyrus pyrifolia other than the fruit are
authorized for import into the United States from Japan.
The commenter also stated that Monilinia polystroma is reported on
Pyrus spp. in Japan and provided a citation as evidence (van Leewen et
al. 2002). The commenter asked if APHIS reviewed this citation as part
of the pest risk assessment.
While APHIS has reviewed the citation noted by the commenter, we
found no evidence that this fungus is associated with the particular
species of pear (Pyrus pyrifolia) that is the subject of the pest list.
The commenter disagreed with our statement that V. nashicola and M.
fructigena can be found visually during the phytosanitary certification
inspection when seasonal growing conditions are conducive for
infection. The commenter noted that fruit infected with these fungi can
appear normal, as latent infections under the calices of fruit and on
stems are not easily visible upon inspection and must be identified
microscopically. The commenter added that these latent infections can
be prevalent depending upon climate and growing season and expressed
concern that they may escape detection by packers and government
inspectors. Another commenter concurred with respect to M. fructigena,
noting that we prescribed no treatment for the pathogen and that
symptomatic fruit would not be easily visible at the time of packing.
While the possibility exists that latent infections of these fungi
may escape detection during inspections, we have determined that the
likelihood of establishment of the disease via fruit is
[[Page 21169]]
low. Should commercial shipments of sand pear latently infected with
these fungi escape detection, the fruit would still need to be
deposited in an orchard with conditions adequate to allow the fungus to
grow and sporulate. We consider such a confluence of conditions to be
highly unlikely to occur. Moreover, under the systems approach already
in place for export of sand pears from Japan there have been no
significant pest interceptions; the same measures will be in place for
fruit from the approved new growing areas in Japan.
Commenters also noted potential risks regarding pests that we
included in the list of pests likely to follow the export pathway and
suggested that additional mitigations are warranted.
A commenter expressed concern about two pseudococcidae included in
the pest list, Crisicoccus matsumotoi (Siraiwa) and Planococcus
kraunhiae (Kuwana). The commenter stated that pseudococcidae, or
mealybugs, are strictly regulated in foreign agricultural trade, and
that a potential risk exists of mealybug eggs, nymphs, or adult females
going undetected in sheltered areas on imported fruit. The commenter
noted that because mealybugs have a protective coating, routine
packinghouse procedures may not remove all mealybugs from fruit and
cited a study showing that infested apples can retain mealybugs,
particularly eggs, on stems after washing and brushing. Finally, the
commenter added that mealybugs can survive cold storage and transport.
We note that, in addition to visual inspection, orchard fruit
bagging is an effective mitigation for mealybugs and is a requirement
in the current operational workplan for sand pear from Japan.
Another commenter reviewed the list of pests that we determined to
have a reasonable likelihood of following the pathway of sand pears
imported from Japan to the United States. The commenter stated that
three of these pests--peach fruit moth, yellow peach moth, and
Manchurian fruit moth--are of special concern because they are fruit-
borers, allowing them to move in fruit consignments and making them
hard to detect. One commenter recommended that APHIS require fruit
bagging as a mitigation measure against fruit-borers.
As noted above, we require orchard fruit bagging in the operational
workplan for sand pear from Japan. Fruit bagging effectively prevents
boring insects from boring into the fruit.
A commenter raised a concern about the introduction into the United
States of Alternaria gaisen via imports of sand pear from Japan, citing
evidence of its interception in imports to the United States and
Australia. The commenter noted that this fungal disease invades young
fruit via lenticels and shows as a black speck on brown fruit, making
it hard to detect visually.
While it is possible that signs of Alternaria gaisen may go
undetected during inspections, the likelihood of the disease becoming
established in the United States through the movement of sand pear
fruit is low. As with M. fructigena and V. nashicola, discussed above,
shipped fruit infected with A. gaisen would have to be exposed to an
orchard under conditions optimal for fungal growth and sporulation,
which as we noted with the other fungi is an unlikely situation.
Moreover, under the systems approach already in place for export of
sand pears from Japan, there have been no interceptions of this fungus,
and the same fungus mitigation measures will be in place for the new
growing areas in Japan approved to export sand pear to the United
States.
Workplan
One commenter noted that the 1998 workplan measures for sand pear
exports from Japan to the United States continue to be followed, even
though an export conditions document for fresh sand pear dated August
2007 omits many of the mitigations in the workplan. The commenter
recommended that we continue to use the workplan measures with the
addition of seasonal assessment for fungi and scab.
The operational workplan for exports of sand pears from Japan to
the United States has been revised to include the revised pest list. We
have also ensured that the necessary mitigations listed in the 1998
workplan are included in the revised workplan to address quarantine
pests and diseases of concern. The 2007 export conditions document
cited by the commenter was used by exporters, packinghouses, and NPPO
officials of Japan as a reference document only. Growers, inspectors,
and other involved parties are required to implement requirements in
the operational workplan and meet the conditions described before sand
pears can be shipped.
The same commenter recommended that specific weather and seasonal
guidelines be considered with respect to mitigating fungi (including
scab) infections of fruit. The commenter noted that such infections
vary year-to-year and are affected by seasonal rainfall and humidity.
Accordingly, the commenter suggested that APHIS add requirements to the
operational workplan for orchards to assess weather potential for fungi
(including scab) in a given season and to assess the fruit for fungi
and scab symptoms after an appropriate incubation period has passed.
The commenter stated that APHIS could decide at that time whether to
allow the block to be part of an export program rather than using
inspection of packed fruit.
Scab was not reported as of quarantine concern for sand pears from
Japan in the updated pests list. The mitigation measures already in
place show efficacy in mitigating fungi (including scab) diseases
throughout all seasons of sand pear production in Japan and should
continue to be equally efficacious with respect to our proposal to
allow export of sand pears from additional growing areas in Japan. For
this reason, we are making no changes in response to the commenter.
Site Visits
One commenter stated that after completion of the operational
workplan, APHIS should conduct a site visit to regions in Japan to
confirm the operational viability of the mitigation measures.
We are making no changes in response to the commenter. In December
2019, APHIS reached an agreement with the NPPO of Japan regarding
details of the systems approach in an operational workplan. The NPPO of
Japan is obligated to fulfill its responsibilities under the systems
approach as a signatory to the IPPC. We have determined that it is not
necessary for us to monitor program activities on site unless we have
reason to believe that such activities may not be adequately mitigating
pest risks. Thus, we do not plan to make periodic site visits. This is
consistent with our practice in other import programs. We will,
however, provide program oversight by conducting audits if quarantine
pests are intercepted or as otherwise warranted. By conducting joint
orchard audit inspections with the NPPO of Japan, APHIS reserves the
right to verify if the growing conditions of the production areas have
been satisfied.
Therefore, in accordance with Sec. 319.56-4(c)(4)(ii) of the
regulations, we are announcing our decision to revise the requirements
for the importation of fresh sand pears from Japan into the United
States. The revised conditions are as follows:
All sand pears must be bagged on trees to exclude pests in
accordance with the operational workplan.
The sand pears must be accompanied by a phytosanitary
[[Page 21170]]
certificate (PC) issued by the NPPO of Japan.\3\
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\3\ We note that sand pears from Japan may continue to be
imported into Hawaii under permit, and subject to inspection in
Hawaii, without any further phytosanitary requirements.
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The sand pears are subject to inspection at the port of
entry into the United States.
Only commercial consignments of Japanese sand pears may be
imported into the United States.
The sand pears must be imported under permit.
These revised conditions will be listed in the Fruits and
Vegetables Import Requirements
database (available at https://epermits.aphis.usda.gov/manual). In
addition to these specific measures, fresh sand pears from Japan will
be subject to the general requirements listed in Sec. 319.56-3 that
are applicable to the importation of all fruits and vegetables.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the reporting and recordkeeping requirements included in
this notice are covered under the Office of Management and Budget
control number 0579-0049.
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 notice, please contact Mr. Joseph Moxey,
APHIS' Information Collection Coordinator, at (301) 851-2483.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this action
as not a major rule, as defined by 5 U.S.C. 804(2).
Authority: 7 U.S.C. 1633, 7701-7772, and 7781-7786; 21 U.S.C.
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Done in Washington, DC, this 1st day of April 2020.
Michael Watson,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2020-08030 Filed 4-15-20; 8:45 am]
BILLING CODE 3410-34-P
