[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\ To view the notice, pest list, CIED, economic evaluation 
assessment, and the comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2019-0057.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \2\ https://www.cabi.org/isc/datasheet/17685.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     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