[Federal Register Volume 89, Number 139 (Friday, July 19, 2024)]
[Notices]
[Pages 58703-58713]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-15887]


 ========================================================================
 Notices
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
 
 ========================================================================
 

  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.

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

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; 
[email protected].

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 https://epermits.aphis.usda.gov/manual; 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.
---------------------------------------------------------------------------

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

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

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

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

    \3\ To view the proposed rule, go to: https://www.regulations.gov/document/APHIS-2007-0152-0001.
---------------------------------------------------------------------------

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

    \4\ To view the notice, PRA, CIED, and the comments we received, 
go to: https://www.regulations.gov/document/APHIS-2021-0078-0001.
---------------------------------------------------------------------------

    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.''
---------------------------------------------------------------------------

    \5\ Suffert et al., 2018. Identification of New Pests Likely to 
Be Introduced into Europe with the Fruit Trade. 48 EPPO Bulletin 
144, 150.
---------------------------------------------------------------------------

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

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

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

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

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

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

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

    \9\ To view this Federal Order, go to: https://www.aphis.usda.gov/import_export/plants/plant_imports/federal_order/downloads/2021/da-2021-04.pdf.
---------------------------------------------------------------------------

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

    \10\ SAG's National Lobesia botrana control program, including 
information about inspections, can be found here: https://www.sag.gob.cl/sites/default/files/Estrategia%20Programa%20Nacional%20Lobesia%20botrana.%20Temporada%202023-2024.pdf.
---------------------------------------------------------------------------

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

    \11\ SAG's National Lobesia botrana control program specifying 
trap density can be found here: https://www.sag.gob.cl/sites/default/files/Estrategia%20Programa%20Nacional%20Lobesia%20botrana.%20Temporada%202023-2024.pdf.
---------------------------------------------------------------------------

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

    \12\ Current outbreaks are listed at: https://www.sag.gob.cl/ambitos-de-accion/mosca-de-la-fruta.
---------------------------------------------------------------------------

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

    \13\ The treatment manual is available at: https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf.
---------------------------------------------------------------------------

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

    \14\ To view the final rule, go to: https://www.regulations.gov/document/APHIS-2010-0082-0031.
---------------------------------------------------------------------------

    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 
https://acir.aphis.usda.gov/s/). 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