Notice2024-15887
Importation of Grapes From Chile Into the United States
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Published
July 19, 2024
Issuing agencies
Agriculture DepartmentAnimal and Plant Health Inspection Service
Abstract
We are advising the public of our decision to revise the requirements relative to the importation into the United States of fresh table grapes from regions of Chile where European grapevine moth (Lobesia botrana, EGVM) is either absent or at very low prevalence. 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 determined that, in addition to the existing option of methyl bromide fumigation for EGVM and Chilean false red mite (Brevipalpus chilensis), grapes from Chile may be safely imported under a systems approach or irradiation for EGVM and B. chilensis. Current mitigation measures for Ceratitis capitata, or Medfly, will remain unchanged.
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[Federal Register Volume 89, Number 139 (Friday, July 19, 2024)]
[Notices]
[Pages 58703-58713]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-15887]
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Notices
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Federal Register / Vol. 89, No. 139 / Friday, July 19, 2024 /
Notices
[[Page 58703]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. APHIS-2021-0078]
Importation of Grapes From Chile 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 revise the
requirements relative to the importation into the United States of
fresh table grapes from regions of Chile where European grapevine moth
(Lobesia botrana, EGVM) is either absent or at very low prevalence.
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 determined that, in addition to the existing
option of methyl bromide fumigation for EGVM and Chilean false red mite
(Brevipalpus chilensis), grapes from Chile may be safely imported under
a systems approach or irradiation for EGVM and B. chilensis. Current
mitigation measures for Ceratitis capitata, or Medfly, will remain
unchanged.
DATES: The articles covered by this notification may be authorized for
importation under the revised requirements after July 19, 2024.
FOR FURTHER INFORMATION CONTACT: Ms. Claudia Ferguson, Senior
Regulatory Policy Specialist, RCC, IRM, PPQ, APHIS, 4700 River Road,
Unit 133, Riverdale, MD 20737-1236; (202) 836-0149;
<a href="/cdn-cgi/l/email-protection#63200f0216070a024d2506110416100c0d23161007024d040c15"><span class="__cf_email__" data-cfemail="90d3fcf1e5f4f9f1bed6f5e2f7e5e3fffed0e5e3f4f1bef7ffe6">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
Background
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 U.S. Department of Agriculture's (USDA's) 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 or disseminated
within the United States.
Section 319.56-4 of the regulations provides the requirements for
authorizing the importation of fruits and vegetables into the United
States, as well as revising existing requirements for 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 on the internet at <a href="https://epermits.aphis.usda.gov/manual">https://epermits.aphis.usda.gov/manual</a>; this address provides access to the
Agricultural Commodity Import Requirements database, or ACIR.\1\ 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
documentation and determination available for public comment.
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\1\ The internet address listed in the regulations had
previously provided access to the Fruits and Vegetables Import
Requirements database, or FAVIR. However, on September 30, 2022, the
FAVIR database was replaced by the ACIR database.
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Chile table grapes (Vitis vinifera L.) are currently listed in ACIR
as authorized for importation into the United States subject to methyl
bromide fumigation. This requirement was first adopted in 1960 as a
risk mitigation measure against the Chilean false red mite (Brevipalpus
chilensis), subsequently revised to apply only if quarantine pests were
intercepted, and, following frequent pest interceptions, reinstated in
1996 for all shipments. Chile table grapes from areas of Chile under
quarantine for Medfly (Ceratitis capitata) are subject to additional
pest mitigation measures, which we did not propose to change.\2\
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\2\ We will, however, clarify that irradiation is an approved
phytosanitary treatment for Medfly. This is specified in our PPQ
Treatment Manual, but not currently reflected in ACIR.
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On August 27, 2008, we published in the Federal Register (73 FR
50577-50582, Docket No. APHIS-2007-0152) a proposed rule \3\ to allow
the importation of fresh table grapes from Chile into the continental
United States under a systems approach. Following an outbreak of
European grapevine moth (Lobesia botrana, EGVM) in Chile that same
year, and subsequent public comments on the proposed rule regarding the
outbreak, APHIS elected not to finalize the proposed rule, as the
proposed systems approach did not include EGVM-specific measures. Since
that time, we have continued to require that table grapes imported from
Chile receive methyl bromide fumigation, which also mitigates the risk
of EGVM.
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\3\ To view the proposed rule, go to: <a href="https://www.regulations.gov/document/APHIS-2007-0152-0001">https://www.regulations.gov/document/APHIS-2007-0152-0001</a>.
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The national plant protection organization (NPPO) of Chile,
Servicio Agr[iacute]cola y Ganadero (SAG), has requested that APHIS
revise the import requirements for grapes from Chile to the United
States to allow the export of table grapes from areas of Chile where
EGVM is either absent or at very low prevalence (the Arica and
Parinacota, Tarapac[aacute], Antofagasta, Atacama, Coquimbo, and
Valpara[iacute]so regions of Chile) under an APHIS preclearance program
for a systems approach in Chile, or irradiation treatment. In response
to this request, APHIS prepared a new pest risk assessment (PRA) that
evaluates the risks associated with importation of commercially
produced fresh grapes (Vitis vinifera L.) for consumption from Chile
into the entire United States. Based on the PRA, a commodity import
evaluation document (CIED) was prepared to identify phytosanitary
measures that could be applied to grapes from Chile to mitigate pest
risk. The CIED recommended that commercially produced shipments of
fresh table grapes originating from the Arica and Parinacota,
Tarapac[aacute], Antofagasta, Atacama, Coquimbo, and Valpara[iacute]so
regions of Chile could be imported into the United States under an
APHIS preclearance program for a systems approach or irradiation
without the risk of introducing quarantine pests.
Accordingly, in accordance with the requirements of Sec. 319.56-4,
we
[[Page 58704]]
published a notice \4\ in the Federal Register on October 17, 2022 (87
FR 62783-62784, Docket No. APHIS-2021-0078), in which we announced the
availability, for review and comment, of the PRA and CIED. We also made
available an economic effects assessment, or EEA, which contextualized
the possible economic impacts associated with the notice.
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\4\ To view the notice, PRA, CIED, and the comments we received,
go to: <a href="https://www.regulations.gov/document/APHIS-2021-0078-0001">https://www.regulations.gov/document/APHIS-2021-0078-0001</a>.
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We solicited comments on the notice for 60 days ending December 16,
2022. We extended the deadline for comments until January 17, 2023, in
a document published in the Federal Register on December 13, 2022 (87
FR 76174, Docket No. APHIS-2021-0078).
We received 45 comments by that date. They were from producers,
importers, United States and Chilean trade associations, industry
groups representing domestic table grape producers, the NPPO of Chile,
a port authority, a State department of agriculture, a State natural
resources and environmental agency, and a private citizen. Thirty-four
commenters expressed support for the notice, and two opposed it. The
remaining nine commenters did not overtly express support or
opposition, but posed questions, offered recommendations, or requested
additional time to comment. Of the comments supporting the notice, 21
included a request for us to finalize the notice expeditiously. The
comments are discussed below by topic.
General Comments
Four commenters asked us to extend the comment period by 75 days.
We extended the comment period by 30 days, which we consider
appropriate given our prior outreach efforts to stakeholders in
connection with this action. This includes: Making the PRA and CIED
available for stakeholder review and providing an informal opportunity
for comment before the notice was published in the Federal Register;
providing briefings for the domestic table grape industry within the
United States and the National Plant Board, which represents State
plant protection organizations within the United States, regarding the
provisions of the systems approach; and conducting a virtual site visit
of Chilean grape production systems for domestic stakeholders.
Two commenters asked us to disclose the operational workplan (OWP)
and reopen the comment period.
The OWP is a government-to-government document formulated using the
CIED and PRA, which were made available for public review and comment.
It contains guidance on the detailed implementation of the systems
approach that is outlined in the CIED without expanding or reducing its
scope. The use of OWPs allows APHIS to adjust the details of how to
execute the systems approach, within the bounds of the requirements
laid out in the CIED, in response to situations such as changes in pest
distribution and/or population density within a particular region, or
technological advances. The OWP allows the Agency to work nimbly to
adjust to operational realities within the parameters and strictures
set forth by the CIED. Because the OWP is a government-to-government
document that provides internal guidance regarding implementation of
APHIS import requirements once they have been finalized, and because
the OWP does not deal with subject matter outside the scope of the
documents disclosed for notice and comment, it is long-standing APHIS
policy not to publish draft OWPs for public review and comment. The OWP
functions not as a document that provides the underlying basis for
APHIS' determination, but as a further expression, and consistent with
the requirements, of the CIED. As such, the non-disclosure of OWP does
not deprive the public of ample opportunity for notice and comment.
One commenter requested access to all documentation supporting the
PRA and CIED and asked us to reopen the comment period. The commenter
also stated that they requested this information by filing a Freedom of
Information Act (FOIA) request and, in response, only received the
comments that APHIS received during the informal stakeholder input
process.
The commenter is referencing a FOIA request received by APHIS in
April 2022. The FOIA request specifically requested ``all public
comments, including any attachments or supporting documentation
submitted and received by APHIS'' during the informal stakeholder input
process. APHIS provided this information to the requester in November
2022. We have no record of the requester expanding the scope of this
request to include additional records.
We do not believe that reopening the comment period is warranted,
as all of the documentation supporting the PRA and CIED is cited in
those documents, and the majority of this information is publicly
available (e.g., published, peer-reviewed literature) or available upon
request (e.g., data from the Agricultural Quarantine Activity System,
or AQAS, and the Agricultural Risk Management System, or ARM). APHIS
does not consider this information necessary in order to provide
meaningful comment on the systems approach, particularly in light of
the extensive outreach efforts to stakeholders that took place before
the notice was published, including a virtual site visit. All documents
essential for ample opportunity for notice and comment have been
disclosed.
A commenter asked whether methyl bromide fumigation will remain an
option for entry of the grapes into the United States if irradiation is
not a feasible option for an importer.
Methyl bromide fumigation will remain an option.
Two commenters said that methyl bromide fumigation should be an
option if the systems approach fails and grapes have pests.
If pests are detected in a shipment during the mandatory
preclearance inspection in Chile, methyl bromide fumigation will remain
an option for export of the grapes to the United States, provided that
the pests detected can be addressed by methyl bromide fumigation.
If pests are detected in a shipment during an inspection at the
port of entry, the possibility of methyl bromide fumigation as a
remedial measure will be determined on a case-by-case basis. This
determination will be based on whether the port has methyl bromide
fumigation capacities and whether the pest detected can be addressed by
methyl bromide fumigation.
Detection of quarantine pests on a shipment imported under the
systems approach will trigger traceback, and could result in suspension
of production sites and/or packinghouses from the systems approach,
and/or reevaluation of the systems approach itself.
One commenter stated that APHIS failed to evaluate whether methyl
bromide fumigation could be replaced with other fumigation methods,
e.g., ethyl formate, phosphine, ozone, or multiple fumigants. As such,
the commenter stated that the notice was issued in violation of the
Administrative Procedures Act (5 U.S.C. 500 et seq.) insofar as there
was not evidence of reasoned decision making because the Agency failed
to consider alternatives to methyl bromide fumigation apart from the
systems approach.
While we are committed as an Agency to evaluating alternatives to
the use of methyl bromide, the commenter misunderstands the basis for
the notice, which was articulated in the initial notice and its
supporting
[[Page 58705]]
documentation. When a change is being sought to the conditions
governing the importation of a commodity that is already authorized for
importation into the United States, as is the case with Chilean grapes,
the NPPO of the relevant exporting country must submit information in
support of the requested change in accordance with 7 CFR 319.5.
Pursuant to these regulations, APHIS was asked by the NPPO of Chile to
evaluate whether a systems approach or irradiation would mitigate the
risk of introducing pests of concern to the United States relevant to
the importation of table grapes. In response to that request, and in
accordance with the regulations, we prepared a pest risk analysis
evaluating the risk associated with the requested change. The NPPO did
not ask us to evaluate other fumigation methods, nor include
information regarding other fumigation methods, and it would have
therefore been inconsistent with our regulatory process to do so.
One commenter asked that we require the NPPO of Chile to fumigate
imported grapes with sulfur dioxide once the Environmental Protection
Agency (EPA) approves the use of sulfur dioxide as a pest mitigant.
As the commenter stated, sulfur dioxide is not currently approved
by the EPA for use as a pest mitigant. If such approval occurs, APHIS
would be open to evaluating the efficacy of sulfur dioxide as a
treatment for table grapes from Chile if requested, in accordance with
our regulations in 7 CFR part 305, which govern the approval process
for phytosanitary treatments. APHIS would not require the use of sulfur
dioxide, if it is determined to be efficacious, unless evidence emerges
that the alternate conditions for importation of grapes from Chile into
the United States (methyl bromide fumigation, irradiation, or the
systems approach) are not effective.
Pest Risk Assessment
Four commenters requested additional assessments of the pest risk
of potential tortricid pests, including Accuminulia buscki. The
commenters requested that these assessments address the presence of A.
buscki in Chilean table grapes, its potential to impact vineyards in
the United States, and the potential impact this species could have if
transmitted to the United States. Several of the commenters also
expressed doubt that a lack of interceptions could be considered
evidence for a weak pathway, since most grapes are fumigated at ports
of entry into the United States and thus presumably not inspected as
regularly as other commodities, or fumigation is effective against A.
buscki and therefore the pest would not be detected, or A. buscki has
been present but has not been identified as such. One commenter noted
that A. buscki has been intercepted on grapes imported into the United
States from Chile.
The PRA addresses the concerns brought up by the commenters. While
we do not know of the presence of A. buscki and the other potential
tortricid pests in Chilean table grapes, we do know that grapes are a
host for these moths, and because of this, we started our baseline
rating at the highest rating (``High'') for all but one of the
tortricid species. However, the tortricids (other than EGVM) identified
in the PRA have a low likelihood of establishing via this pathway
because the life stage most likely to be associated with the commodity
is the larva, which feeds externally on the fruit and could be noticed
during harvest. Those larvae that avoid detection would have to find a
new host, complete development, find a mate, and establish a
population, all while avoiding being disposed of, succumbing to the
elements, predation, and other sources of mortality.
The PRA considers the pest's potential to impact the United States
by assessing its likelihood of entry and establishment in the United
States. For the reasons outlined in the PRA, we have determined that
the combined likelihood of entry and establishment is ``Low'' via the
pathway of grapes from Chile for all tortricids (other than EGVM).
While the PRA states that these pests are likely to cause unacceptable
consequences if introduced into the United States, we believe that the
mitigations outlined in the CIED will prevent such an introduction for
the reasons articulated in the CIED.
APHIS disagrees that a lack of interceptions cannot be used to
support our determination of a weak pathway. No tortricids or
quarantine significant Lepidoptera have been intercepted on Chilean
grapes since 1984, which includes the period between 1984 and 1996 that
predates the mandatory methyl bromide fumigation requirement. The
interception of A. buscki that one commenter mentioned, citing a 1999
manuscript, refers to a single adult male collected in 1926. We do not
consider this to be sufficient evidence to contradict our
determination.
Finally, the same commenter claimed that APHIS' determination that
A. buscki presented a low risk was not shared by researchers, citing a
European and Mediterranean Plant Protection Organization (EPPO)
bulletin,\5\ which the commenter claimed classified ``A. buscki in the
same risk category as the Chilean false red mite.''
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\5\ Suffert et al., 2018. Identification of New Pests Likely to
Be Introduced into Europe with the Fruit Trade. 48 EPPO Bulletin
144, 150.
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We disagree with the conclusions the commenter draws from this
bulletin. In the bulletin, both species are listed as ``intercepted''
but not ``spreading/emerging.'' Importantly, the caption of the table
listing the species reads, ```intercepted' means that the pest has been
reported as intercepted in trade, but not necessarily on table
grapes.'' Additionally, while this report mentions some of the same
pests as our pest risk assessment, APHIS uses different methodologies
for risk assessment than the methodologies outlined in the EPPO
bulletin. Therefore, direct comparisons are not possible.
Two commenters stated that, while the PRA assesses the risk of
pests individually, it fails to assess the cumulative risk of all pests
over time. The commenters provided a calculation of probability as an
example, and added that grapes grow in tight clusters, increasing the
probability of introduction.
The concept of cumulative risk presented by the commenter is based
on faulty assumptions. The commenter assumes that each pest is
biologically similar in terms of its plant pest status, each has a
commensurate likelihood of attacking the grapes, each is commensurately
likely to survive shipment to the United States, and each is
commensurately likely to become established in the United States, if it
enters the United States. This is not the case. For example, with
regard solely to the likelihood of establishment, there are multiple
factors that must be considered when determining if a pest could
establish in an area, including life stage imported, development time,
likelihood of finding hosts, finding mates, and being introduced into a
suitable environment, all while avoiding mortality factors. In
considering each pest distinctly, the PRA takes into consideration this
variability from pest to pest. Additionally, we considered and factored
into our assessment the physical parameters of the commodity (grape
clusters) when determining if a pest would follow the pathway.
Finally, the PRA adopted a conservative methodology for assessing
likelihood of introduction in certain instances. For example, some of
the pests (e.g., tortricid moths) cause secondary infections, such as
Botrytis, to infect the fruit and/or display visible
[[Page 58706]]
feeding damage. The feeding damage, as well as secondary infections,
can be obvious in the field and would likely be culled, further
reducing pest occurrence on the harvested commodity. We did not
consider this factor in the PRA. Thus, the likelihood of introduction
of some of the pests analyzed in the PRA may be lower than estimated.
Two commenters said that the PRA underestimates the risk of the
Chilean fruit tree leaf folder (Proeulia auraria), stating that the
pest has been intercepted 34 times on blueberries imported into the
United States. One commenter also claimed that we disregarded European
and Australian reports suggesting that P. auraria is an emergent pest
with high potential quarantine risk and of more significance than the
Chilean false red mite, and that we ignored scientific literature
providing that P. auraria is an emerging danger that can be controlled
using pheromone traps.
The PRA does indicate that it is possible that P. auraria larvae
could enter the United States on grapes from Chile. However, pest entry
is only part of likelihood of introduction in the PRA, as the pest
would also have to establish. Establishment would be difficult for the
pest, which feeds externally on grape fruit as larvae, because it would
have to successfully complete development (on a perishable commodity),
find a mate, and establish a population, all while avoiding being
disposed of, succumbing to the elements, predation, and other sources
of mortality. All these factors contribute to a low likelihood of
introduction.
We read and considered the reports from Europe and Australia \6\
but did not cite them. The reports suggest that P. auraria should be
considered a significant pest of grapes. This does not directly address
whether it could follow the pathway of grapes from Chile to the United
States. For that determination, the PRA relied on direct evidence and
factors unique to exporting grapes to the United States. APHIS cites
direct evidence in the PRA, not works that were considered but
determined not germane.
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\6\ Wilstermann et al., 2016. Report on Table Grapes--Fruit
Pathway and Alert List 51.
Suffert et al. 2018. Identification of New Pests Likely to Be
Introduced into Europe with the Fruit Trade. 48 EPPO Bulletin 144,
150.
Biosecurity Australia, 2005. Final Report: Import Risk Analysis
for Table Grapes from Chile 42.
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The literature addressing pheromone traps that the commenter cited
\7\ suggests that pheromone traps could be used to manage P. auraria in
Chile. This literature does not address the pathway of grapes from
Chile into the United States. Based on our determination of a low
likelihood of introduction for the factors listed above, we determined
that risk mitigation measures such as pheromone traps would not be
scientifically justified.
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\7\ Reyes-Garc[iacute]a, Luis et al., 2014. A 4-component Sex
Pheromone of the Chilean Fruit Leaf Roller Proeulia Auraria
(Lepidoptera: Tortricidae). Ciencia E Investigacion Agraria: 187-
196.
Flores, M., et al, 2021. Development of Monitoring and Mating
Disruption against the Chilean Leafroller Proeulia auraria
(Lepidoptera: Tortricidae). In Orchards. Insects 12, no. 7: 625.
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With regard to the commenters' mention of interceptions of P.
auraria on blueberry, the number referenced by the commenter does not
correspond with our records. United States port inspectors have
intercepted Proeulia sp. larvae (not identified to P. auraria) once on
Vaccinium spp. in permit cargo originating from Chile since 1984. As
noted earlier, no tortricids or quarantine significant Lepidoptera,
which includes Proeulia sp., have been intercepted on Chilean grapes
since 1984. This includes the period between 1984 and 1996, which pre-
dates the mandatory methyl bromide fumigation requirement.
These two commenters also said that the PRA underestimates the risk
of the South American fruit tree weevil (Naupactus xanthographus). One
of the commenters stated that APHIS had ignored European and Australian
reports suggesting the pest was a significant risk, and presented five
scientific references that the commenter stated we had failed to
consider in developing our PRA.
We found no evidence that N. xanthographus is regularly associated
with grape clusters. As stated in the PRA, adults are polyphagous and
may attack many parts of the plant, which could include fruit. However,
this pest is not regularly associated with fruit. When disturbed, adult
weevils drop to the ground, so they would likely move off fruit during
harvest. Larvae are root pests and would not be associated with the
harvested commodity. Additionally, the adults do not fly, which would
limit their ability to establish.
Regarding the commenter's claims that the European Union considers
N. xanthographus on the same level as the Chilean false red mite, and
that Australia considers it high risk, while these assessments
recognize that these organisms are pests of grapes, they each use their
own methodologies to rate risk and determine what pests may follow the
pathway that differ from our own. Therefore, direct comparisons between
these assessments and APHIS' assessments are not possible.
Additionally, it would lack context to cite the assessments without a
full discussion of the limits of the assessments based on the differing
methodologies.
The commenter is incorrect that APHIS never considered important
scientific literature on N. xanthographus. We consulted many sources
when developing our risk assessment, including sources referenced by
the commenter.\8\ However, while we cite in the PRA all direct evidence
that informed the assessment, we do not cite sources that were
considered but determined not germane. None of the references cited by
the commenter focused specifically on whether the pest would be
associated with grape fruit or remain with the fruit during harvest. We
cited references that assisted in our understanding of the biology of
N. xanthographus, which led us to determine that fruit for consumption
would not be a pathway for N. xanthographus.
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\8\ W. Vera and J. Bergmann, 2018. Distribution and
Ultrastructure of the Antenna/Sensilla of the Grape Weevil Naupactus
Xanthographus. 81 Microscopy Rsch. & Tech. 590, 590.
A.A. Lanteri and M.G. del Rio, 2017. Naupactus Xanthographus
(Germar) Species Group (Curculionidae: Entiminae: Naupactini): A
Comprehensive Taxonomic Treatment. 51 J. Nat. Hist. 1557, 1557.
C. Aguirre et al, 2015. A PCR-Based Diagnostic System for
Differentiating Two Weevil Species (Coleoptera: Curculionidae) of
Economic Importance to the Chilean Citrus Industry. 108 J. Econ.
Entomology 107, 107.
N. Guzman et al., 2010. Isolation and Characterization of
Microsatellite Loci in the Fruit Tree Weevil Naupactus
Xanthographus. 89 J. Genetics.
W. Vera et al., 2016. Attraction to Host Plant Volatiles and
Feeding Performance of Naupactus Xanthographus (Coleoptera:
Curculionidae) Is Affected By Starvation. 29 J. Insect Behav. 48,
48.
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One commenter disagreed with our risk rating of ``Medium'' for the
likelihood of introduction of EGVM, stating that the assessment fails
to recognize that grapes are distributed nationally and that EGVM
previously became established in California. The commenter also noted
that the data the rating was based on was not made available for public
comment.
We acknowledge in the PRA that grapes are sold in every State,
which results in a high likelihood of entry. However, risk of
introduction has two separate components, likelihood of entry and
likelihood of establishment. In this regard, there are some significant
hurdles that EGVM must overcome that would reduce the likelihood of
establishment. The eggs and larvae are the most likely life stages to
enter, which would have to complete development, find a mate, and
establish
[[Page 58707]]
a population. This must occur all while avoiding being disposed of,
succumbing to the elements, predation, and other sources of mortality.
All these factors contribute to reducing the likelihood of
establishment, and thus the overall likelihood of introduction, which
rated ``Medium.''
Our rating of ``Medium'' for likelihood of establishment
acknowledges that establishment is possible, especially without risk
mitigations. However, as explained above and in further detail in the
PRA, the likelihood of introduction is limited by multiple factors. We
also note that the PRA specifically assesses the risk of introduction
via the hypothetical pathway of commercially produced grapes from Chile
and is therefore based on factors specific to that pathway. A
historical instance of establishment via an unknown pathway does not
contradict our risk rating for the likelihood of introduction.
All sources supporting the PRA are listed in that document and
publicly available or available upon request.
The commenter also disagreed with our risk ratings for B.
chilensis, stating that the assessment fails to recognize that grapes
are distributed nationally, and noting that the data the rating was
based on was not made available for public review.
We acknowledge in the PRA that grapes are sold in every State.
However, we also state that there are some significant hurdles that the
mite must overcome that would reduce the likelihood of establishment,
such as seasonality of host availability, dispersal ability of the
mites, and intended use of the commodity. Our consideration of all
these factors resulted in a rating of ``Medium.''
As stated earlier, all sources supporting the PRA are listed in
that document and publicly available or available upon request.
General Comments on the Systems Approach
One commenter said that a systems approach provides insufficient
protection against known and emerging pests, and that APHIS has not
considered the risk posed by unknown future pests.
We do not agree with the commenter that the systems approach
provides inadequate protection against pest risk. For the reasons
outlined in the CIED, APHIS has determined that the systems approach
will provide an appropriate level of phytosanitary protection against
known pests. APHIS continuously monitors foreign countries for
quarantine pests. If a previously unknown quarantine pest relevant to
the importation of table grapes from Chile arises in the future, APHIS
will reassess the associated pest risk and, if we determine that
current phytosanitary measures would not provide an adequate level of
phytosanitary protection, revise the import restrictions accordingly.
Interception of even one quarantine pest for a commodity at a port of
entry triggers an immediate review of the risk mitigations for that
commodity.
The commenter also stated that, whereas fumigation with methyl
bromide is efficacious for a broad spectrum of plant pests beyond those
specifically identified in the PRA as potentially following the pathway
on table grapes from Chile into the United States, the systems approach
was constructed more narrowly to address EGVM and B. chilensis.
While the mitigations of the systems approach target EGVM and B.
chilensis, the general phytosanitary measures of the systems approach,
including commercial production, culling of damaged fruit, traceback to
production sites, inspection, a phytosanitary certificate issued by the
NPPO, and a Plant Protection and Quarantine (PPQ) Form 203 or vessel
report (which we will require in addition to a phytosanitary
certificate, as discussed later in this document), also mitigate for
pests that were rated ``Low'' for likelihood of introduction in the
PRA. Certain measures, such as packing in pest-exclusionary
packinghouses, also help prevent hitchhiking pests (pests not normally
associated with the fruit) from following the pathway. We are confident
that these measures will sufficiently mitigate the pest risk.
One commenter stated that the systems approach was vulnerable to
manipulation, providing a hypothetical example of a person failing to
report a moth found in a trap. The commenter indicated that the PRA is
flawed because of the failure to account for ``gamesmanship''.
The PRA does not address ``gamesmanship'' in the systems approach
because the PRA does not consider any mitigations (such as those of the
subsequently developed systems approach) during the pathway, and
therefore does not analyze risk based on whether or not mitigations are
followed. Rather, the PRA considers the pest risk potential of
organisms before any mitigations are applied, and the phytosanitary
measures of the systems approach are developed in response to the pest
risks we identify in the PRA.
If APHIS identifies evidence of underreporting or manipulation of
records of trap catches, we may determine not to allow the importation
of any further grapes under the systems approach until corrective
action acceptable to APHIS establishes that such records are accurate
and reliable. We consider the possibility of such general prohibitions
a sufficient incentive for the NPPO to sufficiently monitor the systems
approach program in Chile, and for producers to adhere to the
provisions of the systems approach.
The commenter also stated that the systems approach was vulnerable
to accidents, such as comingling of grapes in packinghouses or problems
caused by grapes grown near the border between regions. The commenter
indicated that the PRA is flawed because of the failure to account for
such accidents.
The PRA does not account for accidents in the systems approach
because, as explained above, the PRA does not consider any mitigations
(such as those of the subsequently developed systems approach) during
the pathway, and therefore does not analyze risk based on whether or
not mitigations are followed. Rather, the PRA considers the pest risk
potential of organisms before any mitigations are applied, and the
phytosanitary measures of the systems approach are developed in
response to the pest risks we identify in the PRA.
Protocols will be in place in packinghouses to prevent comingling
of systems approach and non-systems approach grapes, such as separate
timing of the arrival of grapes grown under the systems approach and
separate storage areas, and these protocols will be included in the
operational workplan. Orchards that are eligible to ship grapes grown
under the systems approach that are on the border of regions that are
not approved to export grapes under the systems approach will be
subject to the necessary trapping and survey requirements to ensure
freedom from quarantine pests.
Moreover, with regard to both the possibility of deliberate
manipulation of the systems approach or accidental lapses in various
provisions of the systems approach, the systems approach consists of
multiple independent but interlocking measures that mitigate pest risk;
if one measure fails, other measures, including mandatory inspections
of packed table grapes under the pre-clearance program in Chile, and
possible additional inspections at the port of entry, remain.
We are confident that the mitigations individually as well as
collectively will mitigate the pest risk.
One commenter stated that the systems approach for plums in Chile
has
[[Page 58708]]
recently been unsuccessful, which casts doubt on the efficacy of the
proposed systems approach.
There is no evidence that the systems approach for plums has been
unsuccessful. EGVM was discovered on plums before there was a systems
approach in place with specific mitigations for the pest. As we alluded
to in the April 1, 2021 Federal Order that first established EGVM-
specific mitigations for the importation of plums from Chile, until
EGVM larvae were detected on precleared plums in February 2021, they
had not previously been considered a host for EGVM.\9\ The systems
approach for the importation of plums from Chile was subsequently
established in a notice published in the Federal Register on January
25, 2022 (87 FR 3756-3758, Docket No. APHIS-2021-0041) after the
detections.
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\9\ To view this Federal Order, go to: <a href="https://www.aphis.usda.gov/import_export/plants/plant_imports/federal_order/downloads/2021/da-2021-04.pdf">https://www.aphis.usda.gov/import_export/plants/plant_imports/federal_order/downloads/2021/da-2021-04.pdf</a>.
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We are confident that the proposed systems approach for table
grapes from Chile will mitigate the risk presented by B. chilensis, L.
botrana, and other quarantine pests.
CIED and Specific Provisions of the Systems Approach
Two commenters asked for details regarding regulated areas for
EGVM, as well as whether, and under what conditions, fruit can be
shipped from a regulated area.
In the case of multiple EGVM captures, there will be a regulated
area following the protocol of Chile's national Lobesia botrana
program. Fruit from a regulated area will only be eligible for export
if it undergoes a phytosanitary treatment, such as methyl bromide
fumigation or other approved treatment, either in Chile or at the port
of first arrival in the United States.
Four commenters asked whether field inspections for EGVM will be
required and requested details about these inspections.
Field sampling of grapes targeting EGVM is an integral part of any
eradication program. However, field sampling is typically initiated in
response to adult captures. According to the systems approach outlined
in the CIED, capture of an adult moth will result in a regulated area
from which grapes will not be eligible to ship to the United States
without a phytosanitary treatment. Because these areas will already be
suspended from participating in the systems approach, there is no
justification to require sampling for larvae as part of the systems
approach.
Information about Chile's eradication program, including
information about field inspections, is available publicly on the SAG
website.\10\ If a larva is detected in the field, it will result in a
regulated area from which grapes cannot be shipped under the systems
approach.
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\10\ SAG's National Lobesia botrana control program, including
information about inspections, can be found here: <a href="https://www.sag.gob.cl/sites/default/files/Estrategia%20Programa%20Nacional%20Lobesia%20botrana.%20Temporada%202023-2024.pdf">https://www.sag.gob.cl/sites/default/files/Estrategia%20Programa%20Nacional%20Lobesia%20botrana.%20Temporada%202023-2024.pdf</a>.
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Three commenters requested more information about EGVM trapping
protocol.
Details on trapping density and action thresholds are typically
reserved for the operational workplan, as this allows the Agency to
work nimbly to adjust to operational realities within the parameters
and strictures set forth by the CIED.
That being said, Chile's national Lobesia botrana program is
available publicly on SAG's website.\11\ In its current form, the
program requires 1 trap per 10 hectares, with a minimum of 1 trap per
production site.
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\11\ SAG's National Lobesia botrana control program specifying
trap density can be found here: <a href="https://www.sag.gob.cl/sites/default/files/Estrategia%20Programa%20Nacional%20Lobesia%20botrana.%20Temporada%202023-2024.pdf">https://www.sag.gob.cl/sites/default/files/Estrategia%20Programa%20Nacional%20Lobesia%20botrana.%20Temporada%202023-2024.pdf</a>.
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One commenter requested that sampling procedures targeting EGVM for
Chilean growers be the same as those for California growers in order to
``level the playing field.'' The commenter also requested further field
sampling and surveys for EGVM, as well as restoration of funding for
this program in the United States.
As explained earlier in this document, field sampling is not a part
of the systems approach, but it is a component of Chile's national
Lobesia botrana program. The sampling procedures used in Chile
(available publicly on the SAG website at the link provided in
footnotes 10 and 11) are based off the same scientific data that were
used to develop the sampling procedures used during eradication efforts
in California.
Domestic EGVM programs and their funding is outside the scope of
this notice.
One commenter stated that the CIED lacks evidence for designating
specific regions of Chile as ``low prevalence'' for EGVM, as the CIED
does not include survey data from recent years and provides no
explanation as to what the phrase ``mainly free'' from EGVM means.
The populations of EGVM in these regions are under official
eradication and suppression efforts by SAG. During the last 4 years,
captures of adult EGVM have not exceeded 100 moths in these regions
during the first flight of the table grape production season. In
contrast, there were over 2,000 adult captures of EGVM in the
Metropolitan region, which did not qualify as an area of low pest
prevalence.
We also note that grapes may only be exported from pest free
production sites in the areas that qualified as low pest prevalence;
areas that qualify for the systems approach will require trapping in
production sites to ensure freedom from EGVM, and production sites that
are within 3 kilometers (km) of locations with positive captures of
EGVM will not be eligible to ship under the systems approach.
The statement that the regions of Chile considered for the systems
approach are ``mainly free of Lobesia botrana'' refers to the fact that
EGVM populations are transient and officially under eradication by SAG.
One commenter stated that the CIED should include a definition of a
``shipping season'' for purposes of counting EGVM captures and
determining eligibility to export under the systems approach. The
commenter suggested that a shipping season should start on October 1.
Due to climatic changes and geographic variability in participation
of the growing areas, we cannot specify a calendar date for the start
of the shipping season. We require recordkeeping of EGVM captures as
part of the systems approach and will use the dates and locations of
any captures of EGVM to determine eligibility of the production sites
to participate in the systems approach.
One commenter said that the Valpara[iacute]so region should not be
eligible to export grapes under the systems approach as it does not
have a low prevalence of EGVM. As evidence, the commenter indicates
that there were 91 EGVM captures by the end of the first flight of the
moth during 2018/2019 season, and that those captures were made in 54
different traps and that 74 captures occurred in 35 different table
grape vineyards.
The populations of EGVM in this region are under official
eradication and suppression efforts by SAG. EGVM captures have
decreased since the 2018/2019 season, with 78 adult EGVM captured in
the Valpara[iacute]so region in the 2023/2024 season. Captures of EGVM
during the intervening years were similarly lower than the 91 moths
captured during the 2018/2019 season. Production sites that are within
3 km of captures will not be eligible to ship under the systems
approach.
[[Page 58709]]
Four commenters asked about the rate for preharvest grape sampling
for B. chilensis, and one commenter requested that it be specified in
the CIED.
Sampling rates are typically reserved for the operational workplan.
As noted earlier, reserving such details for the OWP allows APHIS to
adapt to operational realities within the parameters and strictures set
forth by the CIED. However, the sampling rate identified in the OWP
will be within the same general parameters as that for other
commodities in systems approach programs in Chile and in accord with
International Standards for Phytosanitary Measures No. 6,
``Surveillance,'' produced by the Secretariat of the International
Plant Protection Convention.
One commenter suggested that we require a secondary random sampling
for B. chilensis or other additional mitigation measures.
The phytosanitary measures required by the systems approach,
including mite washes at the packinghouse, already serve as additional
mitigation measures to ensure that no mites are present in exported
table grapes from Chile. If mites are found during phytosanitary
inspections, traceback will be conducted and the production site from
which the grapes were produced will no longer be able to ship under the
systems approach for the remainder of the season. Given these measures,
a secondary random sampling is not supported.
One commenter stated that the window for B. chilensis testing in
the CIED should be reduced from the proposed 1 to 30 days before
harvest to 1 to 15 days, as the longer window increases the risk of a
new generation of mites.
We have determined that preharvest sampling up to 30 days before
harvest is sufficient to ascertain that prevalence of the mite is low.
Although B. chilensis has multiple generations each year, these
generations occur every 30-40 days and overlap with one another, so
mites are likely to be detected during the preharvest sampling if they
are present. The systems approach also requires post-harvest mite
washes, which provide an additional layer of protection to ensure that
no mites are present in the exported table grapes.
One commenter stated that the CIED should specify that, during
testing for B. chilensis, the filtrate in the petri dish must be
analyzed under a microscope.
We agree with the commenter that the filtrate in the petri dish
must be examined under a microscope during testing to establish low
prevalence for a shipping season. Although the CIED published alongside
the initial notice stated that the filtrate must be ``microscopically
examined,'' we have edited this language to ``under a microscope'' to
state this requirement more clearly.
One commenter stated that the CIED did not include data from the
pilot program of a systems approach consisting of low prevalence places
of production for B. chilensis in Chile. The commenter also claimed
that the data were outdated.
Data from the pilot programs are summarized in the CIED. As stated
in that document, there were no detections of live B. chilensis during
the inspections performed in Chile or in the United States.
We disagree that the data are outdated. While the pilot programs
were conducted during the 2002/2003 and 2006/2007 growing seasons, they
tested the efficacy of the control measures for B. chilensis in the
systems approach, and were not therefore dependent on the conditions of
any particular growing season. No additional pilot programs have been
performed because the pilot program provided sufficient evidence that a
systems approach that includes low prevalence of B. chilensis
effectively removes this pest from the importation pathway.
The commenter also said there was a lack of evidence supporting
APHIS' selection of a 6 percent infestation rate with 95 percent
confidence as the sampling standard for B. chilensis.
The ``6 percent'' infestation rate stated in the CIED was based on
extensive surveys in the field over multiple seasons, as stated in the
CIED. However, APHIS has determined that details such as inspection
rates are best kept in the OWP, rather than the CIED. The use of OWPs
allows APHIS to adjust the details of how to execute the systems
approach, within the bounds of the requirements laid out in the CIED,
in response to situations such as changes in pest distribution and/or
population density within a particular region, or technological
advances. We are amending the CIED to remove the specified inspection
rate.
We have extensive experience sampling for B. chilensis in systems
approaches for other commodities from Chile, such as citrus, cherimoya,
kiwi fruit, and pomegranate. The sampling requirements for B. chilensis
in table grapes will match those commodity programs already sampling
for B. chilensis, as well as sampling protocols for B. chilensis in
place in other APHIS systems approaches in South America, such as that
for lemons from Argentina. The proposed rate is consistent with risk in
grapes when compared to other commodities.
Two commenters asked for more information about Mediterranean fruit
fly (Medfly) trapping and descriptions of eradication and regulatory
activities.
As mentioned in the initial notice, the current mitigation measures
for Ceratitis capitata, or Medfly, would remain unchanged. Therefore,
activities related to Medfly are outside the scope of this notice. To
reiterate, APHIS' Medfly-specific requirements for table grapes from
Chile are not part of the systems approach and will remain unchanged as
a result of this notice.
APHIS acknowledges that Medfly outbreaks occur sometimes in Chile.
Chile maintains a national trapping program with the aim of detecting
and eradicating Medfly. SAG regularly communicates updates regarding
Medfly outbreaks to APHIS-PPQ, and current outbreaks are updated on
SAG's website.\12\
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\12\ Current outbreaks are listed at: <a href="https://www.sag.gob.cl/ambitos-de-accion/mosca-de-la-fruta">https://www.sag.gob.cl/ambitos-de-accion/mosca-de-la-fruta</a>.
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Two commenters stated that the CIED lacked detail about
requirements for packinghouses, specifically regarding culling damaged
or diseased fruit. One commenter wanted ``damaged or diseased'' fruit
to be defined so that even fruit with slight damage or disease will be
culled at the packinghouses and only quality fruit without pests will
be imported.
The CIED states that ``all damaged or diseased fruits must be
culled.'' Fruit with any amount of damage or disease, however minor,
should be culled at the packinghouse. APHIS believes the language in
the CIED clearly defines the required actions to ensure pest risk is
mitigated. Any further details of activities to be conducted in the
packinghouse will be contained in the operational workplan.
Two commenters requested that producers in Chile be allowed to pack
outside of pest-exclusionary packinghouses under the systems approach.
We are making no changes in response to the commenters. Pest-
exclusionary packinghouses are an integral part of the systems
approach. As we stated in the CIED that accompanied the initial notice,
requiring packing in pest-exclusionary packinghouses prevents
infestation of fruit by pests after harvest and prevents hitchhiking
pests (pests not normally associated with the fruit) from following the
pathway. Accordingly, to mitigate pest risk, grapes must be packed in
[[Page 58710]]
facilities with pest-exclusionary measures in place.
One commenter claimed that the CIED lacked information about the
processes and criteria for recertification of production sites.
As stated in the CIED, a suspended production site may be
reinstated to export under the systems approach under the following
conditions: An adult capture would require 1 year with no more than 1
adult EGVM trapped, and a larval find would require 2 years without any
immature stages of EGVM found in the field or in packed table grapes.
Additional details concerning the operational execution of these
requirements will be included in the operational workplan.
One commenter requested that the CIED be amended to provide that a
suspended production site not be eligible for reinstatement to export
under the systems approach unless there have been no captures of adult
EGVM for 2 years, rather than 1 year, in order to avoid a mismatch
between initial and reinstatement requirements.
As noted earlier, after an area has been approved to export under
the systems approach, a larval find would require two whole seasons
without any EGVM detections before the area would be eligible for
reinstatement in the systems approach program, whereas an adult capture
would require one whole season without EGVM detections. A larval
detection would indicate a breeding population, whereas adult captures
do not necessarily indicate a breeding population and may instead be
transient individuals. For this reason, we believe one season without
adult captures to be a sufficient amount of time to mitigate risk.
Between trapping and phytosanitary inspections, we are confident
that EGVM populations will be detected.
One commenter stated that the CIED should disclose the remedial
actions that APHIS may take if a production site or packinghouse does
not comply with measures of the systems approach, and that any
noncompliance should automatically make a production site or
packinghouse ineligible for the systems approach for at least the rest
of the shipping season.
If the noncompliance is due to a find of L. botrana or B.
chilensis, remedial actions will begin with suspension of the
noncompliant production site or packinghouse, followed by an
investigation into the cause of the noncompliance. APHIS and SAG will
then identify actions that must be taken that will allow the
packinghouse or production site to be reinstated into the systems
approach program once the pest risk is sufficiently mitigated, if
applicable. If SAG finds that a production site or packinghouse is not
in compliance with the requirements of the systems approach, no table
grapes from the production site or packinghouse will be eligible for
export into the United States without a phytosanitary treatment (methyl
bromide fumigation or irradiation) until APHIS and SAG investigate and
implement appropriate satisfactory corrective actions.
Two commenters stated that there is no guidance for spotting pests
and that the CIED should specify how inspectors will carry out
inspections, including explicitly obligating inspectors to identify
pests at the species level.
The CIED provides the framework for the phytosanitary requirements
APHIS has put forth. Details on the implementation of those
requirements, including expectations for inspectors, will be included
in the bilaterally signed operational workplan. Regarding identifying
pests to the species level, this is not always possible during
inspection depending on the pest and life stage found. However, if
conclusive identification is not possible and the pest is determined to
belong to or share morphological similarities with a genus that
contains a known plant pest of quarantine significance, APHIS policy is
to consider the pest identified to be of quarantine significance.
One commenter stated that the CIED should be modified by providing
that inspectors should be required to conduct visual inspections for
pests using illuminating lamps, not hand lens.
As stated above, details on the implementation of the requirements
laid out in the CIED will be included in the operational workplan. That
being said, we can confirm that inspection tables are equipped with
illumination to facilitate suitable visual detection of pests.
Particularly small pests will be detected through mite washes, as the
wash filtrate will be analyzed under a microscope.
One commenter stated that the CIED should disclose which records
regarding the systems approach must be generated and retained by SAG.
The commenter added that SAG should be required to retain
communications with Chilean producers about EGVM detections or B.
chilensis, and general communications between SAG and grape producers
regarding the systems approach.
SAG will be required to inform APHIS of any detections of EGVM and
B. chilensis in the areas of low pest prevalence. SAG already provides
annual updates on the distribution of EGVM in Chile. Any further
requirements for recording communications would be included in the
operational workplan.
One commenter stated that SAG should be required to retain records
for at least 5 years. The commenter stated that this length of time was
needed to address regulatory incidents.
APHIS agrees that record retention for more than 1 year is
appropriate given the provisions of the systems approach. However, we
do not agree that 5 years of records are warranted. EGVM has three life
cycles or flights per year. Thus, the 5-year retention period requested
by the commenter would cover up to 15 life cycles of the pest, which
far exceeds the number needed in order to investigate individual
regulatory incidents, which presumably would occur within a particular
flight. We consider 3 years, or nine flights, worth of records
sufficient to enable investigations of regulatory incidents, and have
amended the CIED accordingly to require records to be kept for at least
3 years.
The same commenter said that the CIED should be modified to require
that production sites, packinghouses, and SAG retain information about
individuals who have handled consignments of grapes.
Traceability back to production sites and packinghouses will be
required. As stated in the CIED, the identity and origin of the fruit
must be maintained from the grove, through the packinghouse, and
through the exporting process into the United States. We have
determined that this information will be sufficient to backtrack pest
detections, should they occur, and take appropriate remedial actions,
as laid out in the CIED. Information on individuals who handled the
fruit goes beyond the scope of pest risk management.
The commenter also suggested that the CIED be modified so that the
required phytosanitary certificates are more specific about which
measures of the systems approach have been followed, as this would help
with any investigation into a failure of the systems approach and serve
as a reminder to producers to comply with the systems approach.
The intent of the phytosanitary certificate is to have an NPPO-
issued official document that certifies that all provisions of the
systems approach that are required to take place in Chile have in fact
taken place, and that the grapes in the consignment are free of
Brevipalpus chilensis and Lobesia botrana. Given its intended function,
this document would not be an appropriate vehicle to serve as a
[[Page 58711]]
reminder to producers to comply with the systems approach. The
commenter did not provide reason to believe that such a reminder would
be necessary or beneficial, and we believe that the consequences of
failing to follow the measures of the systems approach will serve as
sufficient incentive for producers to comply with its measures.
We also note that APHIS is editing the CIED to require a PPQ Form
203 or vessel report in addition to a phytosanitary certificate issued
by the NPPO prior to export. Like a phytosanitary certificate, the PPQ
Form 203 or vessel report certifies inspection at the country of
origin, and can be used to certify that all in-country requirements
have taken place. However, it is issued by APHIS-PPQ, rather than by
the NPPO of the commodity's country of origin, and is used when a
commodity is subject to an APHIS preclearance program. At
packinghouses, APHIS preclearance personnel will confirm, based on the
identification associated with the consignment, that it was produced
and packed in accordance with the systems approach prior to inspecting
the consignment for quarantine pests.
Other aspects of the systems approach, such as unique
identification and recordkeeping requirements, will provide the
traceability requested by the commenter in the event of failure of the
systems approach.
One commenter expressed doubt that APHIS has adequate resources to
conduct inspections at the port of entry and asked about the frequency
of such inspections.
We affirm that APHIS and Customs and Border Protection (CBP) have
adequate resources for conducting inspections at the port of entry. All
shipments imported under the systems approach are subject to inspection
at the port of entry. The exact frequency of inspections will be at the
discretion of CBP.
One commenter claimed there was a lack of evidence that irradiation
would mitigate risk of EGVM and B. chilensis.
APHIS has determined that a minimum absorbed dose of 400 Gy is
adequate to neutralize all insects except pupae and adults of
Lepidoptera, as set forth in the PPQ Treatment Manual pursuant to 7 CFR
part 305, which contains APHIS' phytosanitary treatment
regulations.\13\ Adults of EGVM are unlikely to follow the pathway
because they readily take flight when disturbed. Pupae of EGVM
typically pupate on vines or in leaves and are therefore unlikely to
follow the pathway. In the unlikely event that pupae are present in
clusters of grape, signs such as webbing and damaged fruit will allow
for detection of the pest during visual inspection, and such fruits
will not be eligible for irradiation.
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\13\ The treatment manual is available at: <a href="https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf">https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf</a>.
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One commenter asked how APHIS will ensure that proper packaging is
used for irradiated grapes and enforce the U.S. Food and Drug
Administration's (FDA) requirements for marking irradiated foods.
APHIS' packaging requirements for articles imported to be
irradiated upon arrival in the United States are listed in Sec.
305.9(f)(3). These requirements include packing in cartons that have no
openings that will allow the exit of the pests of concern and that are
sealed with seals that will visually indicate if the cartons have been
opened. The importer compliance process conducted by APHIS will verify
that all labeling and pest-proof packaging meet these requirements. In
accordance with Sec. 305.9(c), an importer cannot receive a permit
until this process is completed.
The FDA's labeling requirements for consumer-facing packaging of
irradiated foods are outside the scope of APHIS' authority.
The commenter also expressed doubts as to whether there are
sufficient irradiation facilities in the United States to handle grapes
that will need treatment.
Irradiation is not a requirement of the systems approach; rather,
it is authorized as an alternative to the system approach's pest-
specific measures. Importers will be able to consider the current
capacity of irradiation facilities as a factor in their decision making
as to whether to employ the pest-specific measures of the systems
approach or pursue irradiation or fumigation.
Economic Effects Assessment
One commenter disagreed that authorization of the systems approach
would only marginally increase Chilean grape imports, citing the
Chilean Minister of Agriculture's statement that, under the systems
approach, annual table grape imports into the United States from Chile
are expected to increase from $400 million to $650 million.
Contextually, the Chilean Minister of Agriculture was describing a
scenario in which all Chilean grape exports to the United States were
produced under the systems approach and Chile enjoyed a 165 percent
price premium for grapes produced under the approach. As noted in the
initial notice, not all grape-producing areas in Chile are eligible for
the systems approach, and, within a particular region, places of
production and packinghouses will have to meet stringent requirements
in order to participate. Additionally, the premium cited by the
Minister of Agriculture would, in general, significantly exceed current
``at-the-market'' premiums for specialty grapes and would be predicated
on consumer acceptance of that premium.
Chile's table grape exports to the United States increased by 22
percent from the 2021 marketing year to 2022. However, over the last 3
years (2021 to 2023), there has been a decrease in Chilean table grape
acreage and exports. Production increased from 2021 to 2022, but
decreased in 2023. Given the lag between planting new acreage and
harvesting (which is about 3 to 5 years for peak yield), supply chain
constraints, and other macroeconomic factors, it is unlikely that these
trends will change in the short term.
Over the period 2018 to 2022, Chile's table grapes exports were
approximately 780,000 metric tons (MT) valued at $1.0 billion.
Production has hovered around this value for the past 3 years. Chile's
top five trading partners for table grapes were the United States
(275,000 MT), China (99,000 MT), the Netherlands (36,000 MT), the
United Kingdom (23,000 MT), and the Republic of Korea (22,000 MT). In
the unlikely event that Chile diverted an amount of grapes equivalent
to all grape exports from China to the United States, or all exports
from the Netherlands, the Republic of Korea, and the United Kingdom, to
the systems approach, the impact on the U.S. grape industry would not
be economically significant by the current regulatory standard (the
standard establishes a threshold of $200 million or greater). If this
notice increased table grape imports by 99,000 MT, which is Chile's
export volume to China, the domestic price of table grapes would
decrease by a little over 3 percent. Consumers' welfare would increase
by $59 million, which would offset U.S. producers' $27 million loss of
profits. The net benefit to society would be approximately $31 million.
The same commenter expressed the opinion that the EEA
underestimates the competition between Chilean and U.S. industries by
failing to consider the partial overlap in shipping seasons of table
grapes from California and Chile.
We appreciate that the market for table grapes is competitive, and
that changes in the length of the growing season can affect the
counter-seasonality of import markets. That being said, over the course
of the last 4 years, on
[[Page 58712]]
average, less than five percent of Chilean grapes have been exported to
the United States between May and June. In 2020, there was one shipment
of Chilean table grapes in July. However, this shipment was small,
constituting less than a percent of total table grape imports in that
year.
The commenter also claimed that the EEA only focuses on the impact
on the domestic organic grape market, while it should consider impact
on the entire domestic grape market.
The EEA considered all table grapes, not just organic table grapes.
An effect of the systems approach is that it would open the possibility
of organic grape imports from Chile into the United States, which is
precluded altogether under the status quo. Grapes from Chile produced
under the systems approach could possibly be certified organic,
provided that all other requirements for being certified organic are
met. The initial EEA acknowledged this possibility, however, APHIS did
not evaluate the systems approach against the standards set by the
Agricultural Marketing Service for organic certification, but rather
against known plant pest risk.
The same commenter stated that the EEA failed to assess the effects
of a possible failure of the systems approach on: The domestic table
grape industry (in terms of eradication efforts, price drops and the
loss of export markets); the wine grapes, juice grapes, and raisin
grapes industries; and industries of other host crops (almond, apple,
fig, lemon, orange, pear, alfalfa, coffee, plum, and potato).
We understand the commenter's concerns regarding the negative
impacts of a potential outbreak of pests of concern in the United
States. For this reason, we have carefully analyzed the pest risks
associated with the importation of table grapes from Chile under a
systems approach. We have determined that, based upon the PRA, the
measures specified in the CIED will effectively mitigate the pest risk.
The economic effects assessment takes this determination of efficacy as
a presupposition, and analyzes the potential economic effects of this
action accordingly.
In a final rule titled ``Establishing a Performance Standard for
Authorizing the Importation and Interstate Movement of Fruits and
Vegetables'' (Performance Standard rule) and published in the Federal
Register on September 14, 2018 (83 FR 46627-46639, Docket No. APHIS-
2010-0082),\14\ APHIS revised the regulations pertaining to the
importation of fruits and vegetables to provide for approval of changes
to existing requirements using a notice-based process, rather than by
rulemaking. In that rule, APHIS provided that any notices published
using the notice-based approach, as done here, would not contain an
economic analyses but will include APHIS' consideration of trade volume
and other economic factors. APHIS' determination as to whether a new
agricultural commodity can be safely imported is based on the findings
of the pest risk analysis, not on economic factors.
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\14\ To view the final rule, go to: <a href="https://www.regulations.gov/document/APHIS-2010-0082-0031">https://www.regulations.gov/document/APHIS-2010-0082-0031</a>.
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The commenter also said that APHIS has not met the requirements of
the Regulatory Flexibility Act (5 U.S.C. 501) by failing to analyze the
effect of the proposed systems approach on small businesses. The
commenter indicated that APHIS should analyze the effects on grapes
vineyards in the United States with less than $4 million in annual
receipts, noting that the systems approach could affect their insurance
premiums, access to credit, and ability to bear eradication costs.
As indicated above, in accordance with the Performance Standard
rule, APHIS does not prepare an economic analysis, nor are such notices
subject to the Regulatory Flexibility Act. Nonetheless, even if this
decision had been a rule subject to the Regulatory Flexibility Act,
then regulated entities would have fallen within the zone of interest
protected by the Regulatory Flexibility Act, not, in this instance,
domestic vineyards, which are not regulated by the systems approach.
Two commenters stated that the systems approach could adversely
impact domestic fumigators. The commenters noted that if methyl bromide
capacity decreases, the ability to eradicate quarantine pests would be
reduced.
We acknowledge that the initial EEA did not discuss losses that
could be anticipated by domestic fumigators as a result of the systems
approach, and that these possible losses should be evaluated.
Currently, the vast majority of grapes imported into the United States
from Chile (greater than 95 percent) are imported subject to methyl
bromide fumigation at U.S. ports of entry. Grapes produced under the
systems approach would not be subject to such port-of-entry fumigation
unless a quarantine pest that can be neutralized using methyl bromide
fumigation is found or the shipment otherwise does not meet
requirements for entry into the United States.
In order to quantify these potential losses, it thus becomes
necessary to estimate the total annual volume of shipments that will
occur under the provisions of the systems approach. While APHIS has
received word of widespread interest among Chilean producers in
participating in the systems approach, there is significant uncertainty
regarding the volume that will actually be imported under its terms.
This is due in part to the market dynamics mentioned in previous
responses: The Chilean industry has shrunk in recent years, with both
acreage and production trending downwards. If this trend continues, it
will place a stricture on overall grape exports from Chile to the
United States.
Additionally, the systems approach itself may impact trade volume.
The provisions of the systems approach are stringent for places of
production: If a production site does not pass an annual sampling
protocol for low pest prevalence for B. chilensis, or if more than one
adult EGVM has been detected at the production site in the previous
shipping season (after initial approval to participate in the systems
approach) or any immature EGVM has been detected at the production site
in the previous two shipping seasons, the production site may not
participate in the systems approach for that shipping season. In APHIS'
experience with other systems approaches, pest-free places of
production, or places of production with low pest prevalence, can be
difficult to establish and maintain, and often significantly reduce
producer participation, at least initially, irrespective of producer
interest.
Finally, as evidenced by the remarks of Chile's Minister of
Agriculture mentioned earlier in this document, it is possible that
Chilean producers may be anticipating a significant ``at-the-market''
premium for grapes exported under the systems approach in comparison to
fumigated grapes, one that significantly exceeds current premiums in
the United States market and which domestic consumers may not accept.
If producer interest in the systems approach is conditioned on this
anticipated premium, that may also act to reduce producer participation
if the premium is not realized.
With that being said, as noted above, we have modeled a high-end
scenario in which approximately 12.5 percent of Chile's global exports
(99,000 MT) are shipped to the United States under the terms of the
systems approach. Based on dialog with the fumigation industry, a
[[Page 58713]]
containerized ship of Chilean grapes carries approximately between 3856
MT and 5716 MT of grapes, and is fumigated at a cost of approximately
$150,000 per vessel. If 99,000 MT of grapes are shipped to the United
States under the systems approach, this equates to between 18 and 26
vessel shipments of grapes to the United States, resulting in foregone
revenue of between $2.7 million and $3.9 million in aggregate for
domestic fumigators. Again, this is a conservative, high-end estimate,
and actual import volumes could be significantly lower for reasons
discussed above. We have revised the EEA to include this estimate, and
are making the revised EEA available alongside this notice.
Therefore, in accordance with the regulations in Sec. 319.56-4(c),
we are announcing our decision to authorize the importation into the
United States of grapes from Chile subject to the conditions listed in
the CIED that accompanies this final notice.
These conditions will be listed in the ACIR database (available at
<a href="https://acir.aphis.usda.gov/s/">https://acir.aphis.usda.gov/s/</a>). In addition to these specific
measures, grapes from Chile will be subject to the general requirements
listed in Sec. 319.56-3 that are applicable to the importation of all
fruits and vegetables.
Finally, we note that, in addition to the changes to the CIED
discussed earlier in this document (requiring SAG to retain records for
3 years, and requiring PPQ Form 203 or vessel report in addition to a
phytosanitary certificate), we have made additional non-substantive
edits to the CIED to improve its clarity. We are publishing the revised
CIED alongside this notice.
Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501 et seq.), the recordkeeping and burden requirements associated
with this action are included under the Office of Management and Budget
(OMB) 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' Paperwork Reduction Act Coordinator, at (301) 851-
2533.
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 15th day of July 2024.
Michael Watson,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2024-15887 Filed 7-18-24; 8:45 am]
BILLING CODE 3410-34-P
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