[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Rules and Regulations]
[Pages 94217-94230]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-31013]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2014-0092]
RIN 0579-AE17


Importation of Lemons From Northwest Argentina

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the fruits and vegetables regulations to allow 
the importation of lemons from northwest Argentina into the continental 
United States. As a condition of entry, lemons from northwest Argentina 
would have to be produced in accordance with a systems approach that 
includes requirements for importation in commercial consignments; 
registration and monitoring of places of production and packinghouses; 
pest-free places of production; grove sanitation, monitoring, and pest 
control practices; treatment with a surface disinfectant; lot 
identification; and inspection for quarantine pests by the Argentine 
national plant protection organization. Additionally, lemons from 
northwest Argentina will have to be harvested green and within a 
certain time period, or treated for Mediterranean fruit fly in 
accordance with an approved treatment schedule. Lemons from northwest 
Argentina will also be required to be accompanied by a phytosanitary 
certificate with an additional declaration stating that the lemons have 
been inspected and found to be free of quarantine pests and were 
produced in accordance with the requirements. This action allows for 
the importation of lemons from northwest Argentina into the United 
States while continuing to provide protection against the introduction 
of quarantine pests.

DATES:  Effective January 23, 2017.

FOR FURTHER INFORMATION CONTACT: Mr. Juan A. (Tony) Rom[aacute]n, 
Senior Regulatory Policy Specialist, PPQ, APHIS, 4700 River Road Unit 
133, Riverdale, MD 20737-1236; (301) 851-2242.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in ``Subpart-Fruits and Vegetables'' (7 CFR 319.56-
1 through 319.56-75, referred to below as the regulations) prohibit or 
restrict the importation of fruits and vegetables into the United 
States from certain parts of the world to prevent the introduction and 
dissemination of plant pests within the United States.
    On May 10, 2016, we published in the Federal Register (81 FR 28758, 
Docket No. APHIS-2014-0092) a proposal \1\ to amend the regulations to 
allow the importation of commercial consignments of fresh lemons from 
northwest Argentina into the continental United States, subject to a 
systems approach.
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    \1\ To view the proposed rule and the comments we received, go 
to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0092.
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    We solicited comments concerning our proposal for 60 days ending 
July 11, 2016. We extended the deadline for comments until August 10, 
2016, in a document published in the Federal Register on July 11, 2016 
(81 FR 44801, Docket No. APHIS-2014-0092). We received 414 comments by 
that date. They were from domestic and foreign citrus producers, State 
and national organizations representing citrus producers, State 
departments of agriculture, an organization of State plant pest 
regulatory agencies, Argentina's national plant protection 
organization, the Argentine embassy, lemon importers and wholesalers, 
longshoremen, U.S. ports of entry, Senators, Representatives, an 
Argentine organization devoted to citrus research, and private 
citizens. Forty-seven commenters supported the rule as proposed. 
Seventy-six commenters generally opposed the proposed rule but did not 
address any specific provisions. The remaining commenters raised a 
number of issues and concerns about the proposed rule. These comments 
are discussed below by topic.
    One commenter stated that the proposed rule failed to comply with 
the requirements of the National Environmental Policy Act (NEPA). 
Specifically, the commenter stated that the proposed rule is a major 
Federal action that significantly affects the human environment, as set 
forth in 40 CFR 1508.18 and 1508.27, respectively, and that the Animal 
and Plant Health Inspection Service (APHIS) should have prepared an 
environmental impact statement or environmental assessment (EA). The 
commenter further stated that none of the APHIS categorical exclusions 
set forth in 7 CFR 1b.3 apply, therefore at a minimum, APHIS is 
obligated to prepare an EA.
    APHIS notes that the APHIS NEPA implementing regulations in 7 CFR 
part 372 specify that additional routine measures used by APHIS are 
categorically exempt from NEPA, in addition to those measures set forth 
in 7 CFR 1b.3. The measures in this rule that will occur within the 
United States fall within the scope of these additional routine 
measures. Accordingly, a categorical exclusion was prepared.
    We do not agree that the rule meets Council on Environmental 
Quality requirements for a ``significant'' Federal action, and thus, by 
definition, cannot be a ``major'' Federal action (a type of significant 
action). The rule is not contextually significant from a policy 
standpoint because it does not substantially alter existing policy 
regarding market access requests, and has severity/intensity only if 
one concedes that the mitigations specified in the rule are ineffective 
in precluding the introduction of quarantine pests. We consider them 
effective, for reasons discussed below.
    One commenter stated that APHIS must take all available measures to 
preclude introduction of invasive species into the United States.
    APHIS agrees. Under the Plant Protection Act (7 U.S.C. 7701 et 
seq.), we are responsible for regulating exports, imports, and 
interstate commerce in agricultural products and other commodities that 
pose a risk of harboring plant pests or noxious weeds in ways that are 
based on sound science and that will reduce the risk of dissemination 
of plant pests or noxious weeds. For this reason we prepared a pest 
risk assessment (PRA) and assigned mitigations with a proven track 
record in the risk management document (RMD).
    One commenter noted that APHIS has also recently published proposed 
rules to allow for the importation of citrus from South Africa (79 FR 
51273, Docket No. APHIS-2014-0015) and Chile (81

[[Page 94218]]

FR 19063, Docket No. APHIS-2015-0051). The commenter stated that 
because both of those proposals deal with a disease or pest of concern 
which is also of concern in the Argentine proposal, APHIS should not 
finalize this rulemaking until we have responded to the comments on the 
other proposed rules.
    We disagree with the commenter that the other rules must be 
finalized before we can proceed with this rule. APHIS considers each of 
its rulemakings as a distinct regulatory action. This is consistent 
both with the language of the Administrative Procedure Act (5 U.S.C. 
551-559) and with case history regarding its implementation.

Site Visits

    Many commenters stated that APHIS should conduct an additional site 
visit before the rule is implemented. Many of those commenters also 
stated that representatives of State governments and subject matter 
experts should be involved in the site visit.
    APHIS conducted an additional site visit to review the details of 
the draft operational workplan in September of 2016. In addition to 
APHIS personnel, a representative from the California Department of 
Food and Agriculture and a former plant pathologist from the United 
States Department of Agriculture, Agricultural Research Service (ARS) 
participated in the site visit as observers. The site visit revealed 
nothing that would require a revision of the PRA.
    Some commenters stated that the site visit should include a 
holistic review of Argentina's production system. Other commenters 
stated that Argentina's traceability system provides holistic records 
of their production system.
    APHIS conducted a thorough review of Argentina's traceability 
system. We looked at the requirements for growers signing up, initial 
site visits of production sites, ongoing oversight during the growing 
season, field and packinghouse inspection, approval for movement and 
the final inspection for phytosanitary certificates. We also reviewed 
the computer system they use, how users are added, who controls 
movement and harvest approvals, and who issues phytosanitary 
certificates. Based on that review, we consider Argentina's 
traceability system to be robust, and we will use it for traceback as 
necessary. However, as specified in the proposed rule, we also consider 
it necessary to be able to identify lots of lemons through the export 
process, from the place of production to arrival at the port of entry. 
This establishes traceability beyond the scope of the Argentine 
domestic traceability system.
    One commenter stated that Argentina's traceability system will not 
be able to trace detections of quarantine pests in U.S. orchards or 
urban areas back to places of production.
    APHIS is confident that if the mitigations in the rule are adhered 
to, quarantine pests will not be introduced into United States orchards 
or urban areas.
    One commenter stated that Argentina's traceability system has 
limited utility for citrus black spot (CBS), given its prolonged 
latency period.
    As we explained in the PRA, fruit is not a pathway for CBS.
    One commenter stated that the site visit should specifically focus 
on the infrastructure of the national plant protection organization 
(NPPO) of Argentina. Another commenter stated that the site visit 
should specifically focus on NPPO oversight of places of production.
    The NPPO of Argentina is the Servicio Nacional de Sanidad y Calidad 
Agroalimentaria (SENASA). During the September 2016 site visit, we 
looked at SENASA's infrastructure and asked questions to address their 
capacity to provide oversight. We remain confident that SENASA will be 
able to adhere to the requirements of the systems approach.
    Some commenters stated that the site visit should specifically 
focus on identifying pest populations in or near production sites.
    During the site visit, we asked questions about pest populations, 
and we looked ourselves at fruit fly traps and at the citrus for signs 
of pests. We did not discover anything that requires revisions to the 
PRA.
    One commenter stated that the site visit should specifically focus 
on organic production sites.
    APHIS did specifically ask about organic production. Argentina may 
in the future ship organic fruit, but currently they do not. Current 
packinghouse practices include chemical treatments that are not 
organic, so any fruit that arrived from an organic production site 
would lose its organic status during packinghouse processing.
    We will ask SENASA about organic production in northwest Argentina, 
as well as pest control guidelines they have developed for organic 
producers. We note that there are provisions in the systems approach 
that preclude the commingling of organic lemons and lemons for export 
to the United States later in the production chain.
    One commenter stated that the site visit should be conducted during 
the summer months in Argentina.
    The 2015 site visit occurred in June, during harvest season in 
Argentina. For this reason, APHIS considered a second site visit during 
the September/October timeframe to be sufficient.
    One commenter stated that two additional site visits are needed. 
Specifically, the commenter stated that after the September site visit, 
a second fact-finding trip should be made to review the harvesting and 
packing operations in Argentina. The commenter stated that a trip at 
that time is needed since so many steps in the systems approach take 
place during the harvesting and packing operations.
    APHIS disagrees. As we explained above, the 2015 site visit 
occurred in June, which is during the harvest season in Argentina. For 
this reason, we do not consider two additional site visits to be 
necessary.
    Two commenters stated that industry stakeholders should be allowed 
to consult with trip members on their findings.
    APHIS prepared a site visit report outlining the findings of the 
visit. The site visit report is available on the APHIS Web site at 
https://www.aphis.usda.gov/aphis/ourfocus/planthealth/import-information/proposal-import-lemons-argentina.
    Many commenters expressed concern that the findings of the 2007 
site visit are outdated.
    The trip in 2007 was conducted by APHIS risk assessors to evaluate 
pest complexes in Argentina in order to prepare the PRA. Information 
from this trip served as a baseline primarily for the pest list in the 
PRA. The PRA, as other commenters noted, has been continually updated 
since this trip through means that APHIS routinely uses to update PRAs, 
such as literature review and ongoing consultation with the NPPO of 
Argentina. More specifically, the PRA was updated in 2014 after 
publication of new research results on seed transmission of citrus 
variegated chlorosis (CVC) in citrus. The PRA was also updated in 2014 
in response to a new finding of citrus greening, also known as 
Huanglongbing (HLB), in Argentina. The PRA was reviewed by APHIS 
personnel at the same time to address comments from Argentina regarding 
the pest list. Furthermore, APHIS conducted a site visit just last 
year, in June of 2015, and the information gathered during that visit 
was used to update the PRA before the proposed rule was published.

[[Page 94219]]

    Two commenters stated that the 2015 site visit was not a technical 
review of Argentina's program.
    The commenters are mistaken. The 2015 site visit was a technical 
review of Argentina's program.
    Three commenters stated that APHIS did not provide enough 
information to the public regarding the 2015 site visit to evaluate its 
adequacy. Two commenters stated that APHIS' slow response to a Freedom 
of Information Act (FOIA) request for documents regarding the 2015 site 
visit is an indication of the inadequacy of the trip.
    APHIS has received the FOIA request and is in the process of 
responding to it. The time taken to respond to the FOIA request is 
consistent with normal timeframes for such requests and not a 
reflection of the adequacy of the trip.
    One commenter stated that APHIS' willingness to conduct another 
site visit is an indication of the inadequacy of the 2015 site visit.
    Usually, APHIS conducts one site visit as close to the 
implementation of a new systems approach as possible in order to aid in 
development of the operational workplan. It was therefore entirely in 
keeping with APHIS policy to conduct the September 2016 site visit 
prior to implementing this final rule, and is not indicative of flaws 
in the 2015 visit.
    The 2015 site visit team included several APHIS risk managers who 
have extensive experience in evaluating foreign production systems to 
determine the ability of those systems to meet requisite mitigation 
measures.

Pest Risk Assessment

    One commenter stated that updated information appears to have been 
incorporated into the PRA in a piecemeal fashion, without checking 
whether any conclusions or assumptions were affected.
    APHIS notes that we have updated the PRA several times. Appendix 1 
of the PRA summarizes updates to the draft PRA in response to public 
and peer review comments; Appendix 2 summarizes updates to the PRA made 
between 2008 and 2015 in response to new scientific information. Any 
time we incorporated new material into the PRA we reviewed the PRA to 
check the conclusions.
    One commenter stated that information provided by SENASA is 
unreliable.
    We disagree with the commenter. We have conducted two site visits 
during which we have verified the information provided by SENASA. They 
have also answered all the questions we have asked and provided all 
information we have requested.
    Two commenters stated that stakeholder comments on the PRA appear 
to have been ignored.
    APHIS posts PRAs and other documents for stakeholder review. As 
noted on the Web site on which the documents are posted, while 
stakeholder comments may result in changes to the PRA, as well as the 
RMD and the rule, it is not APHIS policy to compile or post responses 
to the comments received. This is because these documents are also made 
available for review and comment along with the rules and notices that 
propose to grant market access. Any comments that we receive on the 
documents during that comment period are addressed in a final 
regulatory action.
    APHIS reviewed all of the comments that we received on the PRA and 
RMD. Certain comments, such as statements agreeing that Brevipalpus 
chilensis should be listed as a pest of lemons that is known to exist 
in Argentina, or that green lemons should not be required to be treated 
for Mediterranean fruit fly (Medfly), required no changes to the PRA or 
RMD because the commenters' requests were already reflected in the PRA 
or RMD. Other comments, such as a request to indicate whether the mites 
B. californicus, B. obovatus, and B. phoenicis (Brevipalpus spp.) were 
surface feeders, were incorporated into the PRA and RMD.
    Other suggested revisions, such as revising the RMD to prohibit the 
importation of lemons with leaves attached, would have made the rule 
more stringent that our domestic requirements for the interstate 
movement of citrus fruit from areas quarantined for pests and diseases 
of citrus, and were not incorporated for that reason. Similarly, other 
revisions would have made the PRA or RMD inconsistent with how other 
APHIS documents discuss the same pest of concern or mitigation 
structure.
    Finally, certain comments, such as that the NPPO of Argentina could 
not be trusted to abide by the systems approach, were reiterated during 
the comment period and dismissed for reasons discussed below under the 
heading ``Risk Management Document.''
    One commenter stated that a footnote in the Executive Summary to 
the PRA seems to define the term ``commercially produced,'' but in fact 
only describes conditions of the fruit after harvest and processing. 
The commenter stated that the term ``commercially produced'' should be 
limited to conditions at places of production.
    The term ``commercially produced'' is equivalent to ``commercial 
consignments.'' It includes all aspects of the production system: The 
manner in which the fruit was grown and harvested, the quality of the 
fruit, the manner in which it is packaged, the quantities packaged, and 
the requisite accompanying documentation.
    One commenter stated that the PRA and proposed rule did not 
identify pests of concern for Argentine lemons.
    The pest list in the PRA identifies pests of lemons that are known 
to exist in Argentina.
    One commenter stated that four pathogens--Elsino[euml] australis, 
Phyllosticta citricarpa, Xanthomonas citri subsp. citri (Xcc), and 
citrus leprosis virus--can all infect fruit and stay viable while on 
the fruit, even though capacity for transmission from infected fruit 
may be low. The commenter stated that the answer to the question ``Can 
it follow the pathway?'' for all four pathogens should be changed to 
``yes.''
    APHIS notes that, while these could follow the pathway, the 
capacity for introduction or transmission of disease is so 
epidemiologically insignificant that further analysis was not 
warranted.
    One commenter stated that citrus leprosis virus should have been 
selected for further analysis in the PRA as it is a quarantine pest 
likely to follow the pathway.
    Citrus leprosis virus is not systemic and cannot be transmitted 
apart from viruliferous Brevipalpus spp. mites. It can follow the 
pathway only if it is vectored by the mites. For this reason we do not 
consider the virus to be a quarantine pest likely to follow the 
pathway.
    One commenter stated that the citation in the PRA to the APHIS 
domestic fruit fly quarantine and regulations, which address Medfly was 
outdated and have been replaced with 7 CFR 301.32. The commenter noted 
that in the current regulations, only yellow lemons are regulated 
articles for Medfly.
    The commenter is correct; the citations were outdated. However, 
this does not affect the conclusions of the PRA that green lemons are a 
poor host for Medfly.
    Several commenters stated that the pest risk associated with 
importation of lemons is too high, and that the domestic citrus 
industry would suffer as a result of pest introductions.
    If the mitigations in the rule are adhered to, this pest risk will 
be mitigated. Furthermore, some of these commenters appear to have 
overestimated the likelihood of introduction associated with certain of

[[Page 94220]]

the pests. For example, Cryptoblabes gnidiella and Gymnandrosoma 
aurantianum have never been intercepted in commercial shipments of 
citrus from South America. Both are associated with poorly managed or 
non-commercial citrus, like backyard fruit.
    One commenter stated that B. chilensis should have been rated as 
high risk in the PRA.
    APHIS notes that B. chilensis was in fact rated as high risk in the 
PRA.
    One commenter stated that Brevipalpus spp. mites should all have 
been rated ``High Risk.'' The commenter cited a scientific article on 
Brevipalpus mites and the diseases they transmit \2\ in support of this 
statement.
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    \2\ Childers, C.C. and J.C.V. Rodrigues. 2011. An overview of 
Brevipalpus mites (Acari: Tenuipalpidae) and the plant viruses they 
transmit. Zoosymposia 6:180-192.
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    In that article, Childers and Rodrigues state that the only 
confirmed vector of citrus leprosis in the Western Hemisphere is B. 
phoenicis. The other mites are suspected to be vectors, but are not 
known vectors. Given that we consider B. californicus, B. obovatus, and 
B. phoenicis to be quarantine pests only insofar as they may vector 
citrus leprosis virus, and there is some uncertainty regarding the 
ability of B. californicus and B. obovatus to vector this disease, we 
consider a medium risk rating to be appropriate. It is also consistent 
with how we have rated these pests in other PRAs.
    More importantly, a high risk rating would not have changed our 
mitigations for the pests. Under APHIS policy, both medium risk and 
high-risk pests are subject to pest-specific mitigations beyond port of 
entry inspection, and the mitigations we prescribed to address 
Brevipalpus spp. are based on the possibility that they may vector 
citrus leprosis virus, rather than the risk rating ascribed to the 
pests.
    One commenter stated that the overall risk rating should have been 
higher.
    As we explained above, a higher overall risk rating would not have 
changed the mitigation structure.
    One commenter asked why, if ``not be detected at the port of 
entry'' did not impact risk ratings, port of entry inspection is a 
component of the systems approach.
    ``Not be detected at the port of entry'' was removed as a criterion 
in the PRA because APHIS does not have enough information about 
relative likelihood of detection at the port of entry to be able to 
weight this criterion relative to other elements. As a result, this 
criterion could not substantially impact the risk ratings.
    This does not imply that port of entry inspections are an 
ineffective component of a systems approach. Port of entry inspections 
by U.S. Customs and Border Protection (CBP) are, in fact, capable of 
detecting quarantine pests and are a significant mitigation against 
pests entering the United States. For example, in December 2015, CBP 
detections of Medfly larvae on Spanish tomatoes and Moroccan citrus led 
us to suspend market access for those commodities, pending 
investigations.
    One commenter asked why, if fruit is not an ``epidemiologically 
significant'' pathway for E. australis, P. citricarpa, and Xcc, the PRA 
says ``additional specified risk management options may be required.''
    While we do not consider fruit to be an epidemiologically 
significant pathway for these pests, the pests are subject to domestic 
quarantines within the United States. For the sake of consistency with 
domestic regulations regarding the interstate movement of fruit from 
areas quarantined for CBS, sweet orange scab, and Xcc, we would require 
fruit to be washed, brushed, waxed, and surface disinfected. It is 
worth noting that such washing, brushing, waxing, and disinfecting are 
standard packinghouse procedures both domestically and internationally.
    Likelihood and Consequences of Establishment
    Several commenters stated that citrus-producing areas are 
particularly at risk for establishment of quarantine pests that could 
follow the pathway.
    Incorporating information regarding likelihood of establishment 
would not have affected the pest risk ratings or the risk mitigation 
structure. As we explained above, both medium and high-risk pests are 
subject to pest-specific mitigations beyond standard port-of-entry 
inspection.
    One commenter stated that the PRA does not acknowledge that 
backyard citrus in California is in proximity to ports of entry. Other 
commenters stated that the PRA does not recognize that most quarantine 
pest introductions first occur in urban areas, and are undetected. 
Three commenters stated that urban areas in Texas and California abut 
production areas and expressed concern that pests could become 
established in urban areas with backyard citrus and then spread into 
production areas.
    As we noted above, incorporating this information into the PRA 
would not have affected either the pest risk ratings or the risk 
mitigation structure.
    One commenter stated that Climate-Host interaction for Brevipalpus 
spp. should have been rated ``high.'' The commenter cited a 2012 
reference in the Ninth Report of the International Committee of 
Taxonomy of Viruses \3\ that said that citrus leprosis virus was 
transmitted to several other experimental hosts from other genera 
including Phaseolus vulgaris in support of this statement.
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    \3\ ``Virus taxonomy: classification and nomenclature of 
viruses: Ninth Report of the International Committee on Taxonomy of 
Viruses.'' (2012) Ed: King, A.M.Q., Adams, M.J., Carstens, E.B. and 
Lefkowitz, E.J. San Diego: Elsevier Academic Press.
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    There is no mention in the report of whether the conditions under 
which transmission to P. vulgaris occurred could be reduplicated 
outside of laboratory conditions. The sentence the commenter is 
referring to is immediately preceded by a sentence referring to 
mechanically administering inoculum to induce symptoms in articles 
previously considered non-hosts. This, coupled with the use of 
``experimental'' to describe inoculation of P. vulgaris, suggests the 
study was not intended to reduplicate actual ``field'' conditions.
    In the PRA, we identified the dispersal potential of B. chilensis 
as ``medium'' and of Brevipalpus spp. as ``high.'' One commenter stated 
that the dispersal potential for both B. chilensis and Brevipalpus spp. 
should be high.
    The commenter is correct that the dispersal potential for both B. 
chilensis and Brevipalpus spp. should be the same; however, we disagree 
that the rating for both should be high. Based on the work of Childers 
and Rodrigues, the dispersal potential for both should be medium. Both 
B. chilensis and Brevipalpus spp. are very unlikely to move from one 
orchard tree to another. They both tend to aggregate, they move 
downwind slowly, and they do not balloon--that is, they do not produce 
streamers of silk and travel with wind currents for longer distances.
    One commenter stated that the environmental impact potential for 
Brevipalpus spp. is low, but the introduction of this pest infected 
with citrus leprosis virus would stimulate the use of chemical control. 
The commenter stated that the risk rating should therefore be changed 
to medium. The same commenter also stated that consequences of 
introduction for Brevipalpus spp. should have been considered high.
    We consider the ratings given to Brevipalpus spp. to be accurate. 
Under standard commercial packinghouse procedures, the mites would be 
washed or brushed off, even in the absence of required mitigations. 
Furthermore, citrus leprosis virus is not a systemic

[[Page 94221]]

infection, and mites do not feed on harvested fruit unless doing so is 
absolutely necessary for survival.
    Accordingly, for a non-viruliferous Brevipalpus mite in the United 
States to become a vector of citrus leprosis virus, the infected 
portions of the fruit would have to have abnormally high levels of 
inoculum, the mite would have to be on infested fruit, and the mite 
would have to specifically consume the infected portions of the fruit, 
climb up a tree, and infect the tree.
    Since citrus leprosis virus inoculum is not shed to offspring, this 
would also have to occur during the infected mite's lifetime. We 
consider the probability of this occurring to be extremely remote.
    One commenter stated that the likelihood of introduction for Medfly 
should have considered lemons a conditional host, rather than a 
conditional non-host.
    The designation of lemons as a conditional non-host of Medfly was 
based on research published by ARS scientists \4\ that examined the 
host status of immature lemons.
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    \4\ Spitler, G.H., J.W. Amstrong, and H.M. Couey. 1984. 
Mediterranean fruit fly (Diptera: Tephritidae) host status of 
commercial lemon. Journal of Economic Entomology 77(6):1441-1444.
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    One commenter stated that the PRA did not consider introduction via 
smuggling or diversion. The commenter expressed concern that the fruit 
could be carried to a home while vectoring a pest or disease.
    The PRA addressed the plant pest risk associated with the 
importation of commercially produced and commercially packed fresh 
lemon fruit from northwest Argentina into the United States. Fruit that 
is not commercially grown or packed are outside the scope of the risk 
assessment.

Risk Management Document

    One commenter stated that the RMD requirements are inadequate to 
eliminate the risk of introduction of the quarantine pests identified 
in the PRA, but did not provide the basis for their concern.
    Some commenters stated that the RMD and rule contain safeguards to 
address plant pest risk, and one commenter stated that similar systems 
approaches for citrus from other countries have proven effective. One 
commenter, however, stated that there are no similar systems approaches 
because no other growing area harbors this combination of pests and 
diseases of citrus, but is still asking to market fresh fruit.
    APHIS notes that the PRA for citrus from Uruguay had a very similar 
quarantine pest list--they did not have B. chilensis or Brevipalpus 
spp., but had all other quarantine pests identified in the Argentine 
citrus PRA. Accordingly, many provisions of the Argentine lemons 
systems approach were modeled on the Uruguay citrus systems approach, 
which has been in place for 3\1/2\ years now without incident. 
Furthermore, the Brevipalpus-specific provisions are not new, and have 
been tested for several different commodities in other countries.
    Five commenters expressed concern that Argentina cannot be trusted 
to abide by mitigations in the RMD and rule. Some of these commenters 
cited incidents that they believed showed Argentina handling sanitary 
or phytosanitary issues in deceptive ways. One commenter stated that, 
as a result of the history of SENASA, APHIS needs to exercise continual 
monitoring and oversight over the program.
    Argentina is a World Trade Organization member country and 
signatory on the Agreement on the Application of Sanitary and 
Phytosanitary Measures (SPS agreement). As such, it has agreed to 
respect the phytosanitary measures the United States imposes on the 
importation of plants and plant products from Argentina when the United 
States demonstrates the need to impose these measures in order to 
protect plant health within the United States. The PRA that accompanied 
the proposed rule provided evidence of such a need. Argentina has 
demonstrated the ability to comply with U.S. regulations with respect 
to other export programs.
    We disagree with several of the examples cited as recent 
prevarication by SENASA. APHIS became aware of the presence of A. 
fraterculus in blueberries in Argentina because of a scientific paper 
published by Argentina. The disagreement between APHIS and SENASA 
regarding the presence of B. chilensis in Argentina was based on 
differing opinions regarding whether the pest detected had been 
identified properly. As such, it indicated a difference of scientific 
opinion, rather than an act of deception.
    That said, the 2015 site visit specifically evaluated SENASA's 
oversight of the Argentine production system for lemons to determine 
whether the provisions of the systems approach could be implemented and 
maintained.
    Finally, as provided in paragraph (a) of the proposed rule, APHIS 
would be directly involved in monitoring and auditing implementation of 
the systems approach in Argentina. A determination that the systems 
approach had not been fully implemented or maintained would result in 
remedial actions, including possible suspension of the export program 
for Argentine lemons.
    One commenter expressed concern that the United States Department 
of Agriculture (USDA) cannot be trusted to abide by mitigations in the 
RMD and rule. The commenter referred to a scandal at Hunts Point 
Terminal Produce Market in the Bronx, NY, as an example of USDA 
personnel accepting bribes and kickbacks. The commenter stated that 
even if such events are not commonplace, they still must be factored 
into the risk assessment.
    The bribery and kickback scheme referenced by the commenter was 
revealed in 1999 after a 3-year investigation by the USDA Inspector 
General and involved Agriculture Marketing Service personnel, who have 
no role in the implementation of this rule.
    One commenter asked why, if the mitigations in the RMD are 
effective, the PRA discusses likelihood and consequences of 
introduction.
    The PRA follows our guidelines for PRAs. As such, it discusses the 
likelihood and consequences of quarantine pests that could follow the 
pathway on lemons from northwest Argentina to the United States, in the 
absence of any mitigations. This assessment is a necessary aspect of 
our evaluation of the risk rating for the pests.
    The RMD lists the mitigations that will be applied to prevent pests 
from following the pathway and being introduced.
    Three commenters stated that European Union (EU) detections of CBS 
on fruit from Argentina indicate the inability of Argentina to follow a 
systems approach.
    We disagree with the EU regarding the transmissibility of CBS via 
commercially produced fruit. The point of these statements in the PRA 
and RMD was to point out that Argentina has been able to implement and 
abide by a systems approach for lemons that rests on SENASA having the 
wherewithal to meet phytosanitary requirements. We note that the RMD 
stated that Argentina proposed the EU systems approach to us in its 
entirety as a mitigation structure, and that we rejected adopting it 
outright. Furthermore, the systems approach for Argentine citrus to the 
EU is the same systems approach applicable to U.S. citrus to the EU, 
indicating they consider us equivalent in terms of ability to adhere to 
phytosanitary requirements.

[[Page 94222]]

    It is also worth noting that the EU audit \5\ attributed the 
detections to a lack of traceability of individual lots of fruit to the 
production units in places of production, to some packinghouses 
commingling lemons destined for export with other fruit, and to some 
producers not applying pest controls for CBS. These mitigations, which 
were added to the EU directive following the detections, are all 
aspects of our systems approach. Our systems approach is, in short, 
more stringent than the EU directive was prior to the CBS detections.
---------------------------------------------------------------------------

    \5\ The audit is available online at ec.europa.eu/food/audits-
analysis/act_getPDF.cfm?PDF_ID=12522.
---------------------------------------------------------------------------

    One commenter stated that there is no evidence the EU systems 
approach for lemons from Argentina is equivalent to the systems 
approach proposed by APHIS.
    The two systems approaches are not equivalent, and we did not 
suggest they were. Rather, we made reference to the EU systems approach 
to illustrate that Argentina has the capacity to adhere to a stringent 
systems approach, so that it is plausible that they could adhere to our 
systems approach as well. We state in the RMD that Argentina proposed 
that we simply adopt the EU systems approach, and we rejected that 
proposal.
    One commenter stated that, because of proximity of ports of entry 
to urban areas, and urban areas to citrus production in the United 
States, any lapses from systems approach will have dire consequences.
    The commenter seems to be assuming that, if infested or infected 
fruit is shipped to the United States, it will not be detected at a 
port of entry inspection, and will necessarily result in the 
introduction of quarantine pests into the United States. This 
assumption is, in essence, that port of entry inspections are 
ineffective at detecting plant pests. We disagree with this assumption; 
port of entry inspections are an effective mitigation and have 
precluded two potential introductions of Medfly in the last year alone.
    One commenter stated that there is no definition or list of 
criteria for pests of ``quarantine significance'' in either the PRA or 
RMD. The commenter asked what the criteria are for determining what 
pests are of quarantine significance.
    The PRA, RMD, and rule use the terms ``quarantine significance'' 
and ``quarantine pest'' interchangeably. In Sec.  319.56-2 of the 
regulations, we define a quarantine pest as ``[a] pest of potential 
economic significance to the area endangered by it and not yet present 
there, or present but not widely distributed there and being officially 
controlled.''
    One commenter noted that the RMD says 9 pests of quarantine 
significance were identified, but the PRA lists 10. The commenter asked 
for an explanation of this apparent discrepancy.
    The PRA acknowledges that CBS could follow the pathway, and is a 
quarantine pest, but then cites the 2010 PRA, which determined that, 
even in the absence of packinghouse procedures, fruit is an 
``epidemiologically insignificant'' pathway for CBS, and the conditions 
that would allow for transmission from fruit are nearly impossible to 
occur, even in the absence of standard packinghouse procedures. The RMD 
looked at commercially produced fruit, that is, fruit subject to 
packinghouse procedures and standard industry practices. This led us to 
drop CBS from the list of quarantine pests.
    One commenter noted that in section 1 of the RMD, guidelines for 
growers participating in the program are mentioned as needing to be 
followed. The commenter asked what these guidelines are.
    In the RMD, we explain that these are pest control guidelines that 
a place of production may need to meet in order to qualify for 
registration with SENASA.
    One commenter asked if the operational workplan will contain only 
SENASA's requirements.
    Generally, the operational workplan pertains to APHIS, the NPPO of 
the exporting region, and growers, packinghouses, and persons 
commercially involved in chain of production. It contains details that 
are necessary for day-to-day operations needed to carry out provisions 
of the rule and RMD. This one will be no different.
    One commenter asked what SENASA's requirements are under the 
operational workplan.
    SENASA's requirements include everything specified within the RMD: 
Registration; regular inspections; pest control guidelines; and 
inspections to determine that treatment guidelines are being adhered 
to.
    Additionally, Argentina has place of production requirements apart 
from APHIS' requirements that pertain to all citrus groves in the 
country. These include sanitary guidelines that are developed in 
consultation with Argentine subject matter experts and address 
regulated nonquarantine pest populations that could affect 
marketability of the citrus.
    One commenter noted that the RMD specifies that SENASA must ensure 
that growers are following the ``export protocols.'' The commenter 
asked what those protocols are, and stated that they should be made 
available for public review and comment.
    The protocols are conditions for export established by APHIS in the 
operational workplan. The RMD and the regulatory requirements derived 
from it include a general description of all the phytosanitary measures 
necessary to mitigate pest risk. The operational workplan specifies 
details that are necessary for day-to-day operations needed to carry 
out provisions of the rule and RMD. Operational workplans are available 
to the public upon request only after a rule has been finalized and the 
operational workplan has been signed by APHIS and the NPPO of the 
exporting country. With respect to consulting with stakeholders, APHIS 
typically conducts outreach and consultation during the risk assessment 
and management phases.
    One commenter stated that section 16 of the RMD should specify that 
fruit fly detections must fall below a threshold before a registered 
place of production can resume shipping.
    Immature lemons are a poor host of Medfly. Because of this, 
prevalence levels at a place of production are not germane to whether 
Medfly are more likely to follow the pathway on immature Argentine 
lemons, and it would be incommensurate with risk to cut off a place of 
production based on Medfly detections.
    This policy is consistent with our existing importation 
requirements for lemons from other countries that have Medfly. We have 
no reason to believe these existing requirements have been ineffective.
    One commenter stated that places of production should be suspended 
if B. chilensis is found on the lemons during NPPO inspections.
    In the RMD, we said place of production ``may be suspended'' and 
are ``subject to suspension'' out of recognition that the investigation 
could determine that the fruit was clean when it left the orchard, and 
the pest was introduced later in the production chain.
    Two commenters noted that the rule doesn't contain mitigations for 
CVC and its vectors. The commenters expressed concern that potential 
vectors could transmit CVC if they were allowed to hitchhike on 
exports.
    Glassy-winged sharpshooters are the vector of concern for CVC. They 
are the subject of consistent surveys and are not in northwest 
Argentina. Were they to

[[Page 94223]]

spread into northwest Argentina, the sharpshooters would be removed by 
washing and brushing and standard packinghouse procedures. 
Additionally, as external feeders, they are easy to detect during 
phytosanitary inspections and/or port of entry inspections. Finally, 
CVC cannot follow the pathway of lemons in the absence of a vector.
    One commenter noted that the RMD concludes that seeds are unable to 
transmit CVC directly. The commenter stated that this directly 
contradicts the regulations in 7 CFR 319.37-2, which consider CVC to be 
seed-transmitted.
    A Federal Order published on May 19, 2016, relieved restrictions on 
citrus seed for CVC. The Federal Order is available on the APHIS Web 
site at https://www.aphis.usda.gov/import_export/plants/plant_imports/federal_order/downloads/2016/2016-31.pdf. A rule codifying this Federal 
Order is in development. The citrus seed pest list prepared in November 
2015 is referenced in this Federal Order. The pest list contains our 
current thinking about the transmissibility of CVC and other citrus 
diseases via seed.
    Four commenters expressed concern that the rule does not contain 
mitigations for HLB.
    APHIS has examined whether fruit is a pathway for HLB, and 
determined that HLB is not transmitted via fruit. Therefore, 
mitigations for HLB are not necessary.
    One commenter stated that APHIS should not trust SENASA on the 
scope of the HLB outbreak in Argentina.
    Neither the severity of the HLB outbreak in Argentina, nor its 
distribution, affect whether HLB-specific mitigations need to be 
included in the rule. As we explained above, HLB is not transmitted via 
fruit.
    The same commenter stated that APHIS should not trust SENASA on 
distribution of Asian citrus psyllid (ACP), a vector of HLB, in 
Argentina.
    The distribution of ACP in Argentina is not necessary for us to 
evaluate the risk of it following the pathway via the importation of 
lemons. As documented in the PRA, standard packinghouse procedures will 
remove ACP from the fruit. Only commercially produced fruit, which is 
subject to such procedures and will therefore be free of ACP, can be 
exported to the United States.
    One commenter stated that the PRA should include information about 
distribution of HLB in Argentina.
    APHIS does not consider this information to be necessary, given 
that HLB is not transmitted via fruit.
    One commenter expressed several concerns about CBS. The commenter 
stated that CBS is impossible to eradicate once introduced, that it can 
have a lengthy latency period, and that trees infected with CBS are 
unmarketable.
    APHIS notes that we never questioned the quarantine significance of 
CBS, just its ability to become established via fruit.
    One commenter stated that justifications in the PRA for why CBS 
will not follow the pathway are not accurate. The commenter stated that 
the PRA assumes farmers in Argentina all farm in the same intensive 
manner.
    The commenter is mistaken. In the systems approach for Argentina 
lemons, we have incorporated the same mitigations for CBS for that we 
are using for Florida citrus. These mitigations are based on a separate 
scientific review, which can be viewed on the APHIS Web site at https://www.aphis.usda.gov/plant_health/plant_pest_info/citrus/downloads/black_spot/cbs-risk-assessment.pdf.
    Several commenters stated that APHIS erred in determining that CBS 
cannot follow the pathway on fruit. Another commenter expressed concern 
that CBS could become established in Southern California if infected 
fruit arrived at and were distributed through the Port of Long Beach.
    Both Paul et al.\6\ and Magarey and Holtz \7\ ran infection models 
which found California's climate, including that of Southern 
California, unsuitable for establishment of CBS. While isolated 
microclimates in Southern California could result in small pockets of 
CBS infection, the overall climatic conditions are unsuitable to 
establishment and spread.
---------------------------------------------------------------------------

    \6\ Paul, I., van Jaarsveld, A.S., Korsten, L., & Hattingh, V. 
(2005). The potential global geographical distribution of citrus 
black spot caused by Guignardia citricarpa Kiely: likelihood of 
disease establishment in the European Union. Crop Protection, 24, 
297-308.
    \7\ Magarey, R., Chanelli, S., & Holtz T. (2011). Validation 
study and risk assessment: Guignardia citricarpa, (citrus black 
spot). USDA-APHIS-PPQ-CPHST-PERAL/NCSU.
---------------------------------------------------------------------------

    One commenter stated that APHIS did not take into account either 
the reality of the residential yards in Southern California, or the 
numerous interceptions of Argentine citrus for CBS symptoms in 
shipments to the EU in the years since 2010.
    These two facts do not affect the conclusion on the 2010 PRA that 
the establishment of the disease via the movement of fruit requires a 
combination of biological and climatic conditions that are unlikely to 
occur.
    One commenter stated that the spread of CBS in Florida could be 
indicative of errors in the 2010 PRA.
    The PRA found Florida's environment to be conducive to the spread 
of CBS, and examined only transmission via fruit. The spread of CBS 
within Florida could have occurred through a pathway other than fruit, 
and is not in itself indicative of errors in the 2010 PRA.
    One commenter stated that the EU Food Safety Commission in 2014 
issued a scientific opinion which deemed the risk of entry of the 
causal agent of CBS as moderately likely for citrus fruit without 
leaves.
    APHIS notes that the proposed conditions for importation of lemons 
from northwest Argentina are the same as the conditions we apply to 
export citrus from the United States. We also note that the causal 
organism of CBS has two life cycle stages: A sexual stage represented 
by the ascospores of Guignardia citricarpa Kiely and an asexual stage 
represented by the pycnidiospores of P. citricarpa (McAlpine). These 
two stages are produced at different times, under different 
environmental conditions, at different locations on the plant and 
result in different epidemiological dynamics. The sexual stage of the 
disease may be found in plants and leaves; the asexual stage of the 
disease is found on fruit. The correlation between ascospore discharge 
and infection onset showed that pycnidiospores, the asexual stage, do 
not play a significant role in the disease cycle. For this reason fruit 
is not considered to be a pathway for CBS.
    Several commenters asked how, if we do not know how CBS got into 
Florida, we know it cannot follow the pathway on fruit.
    The PRA examined the biological and climatic conditions necessary 
for establishment of CBS through infected fruit, and determined that 
``the establishment of the disease via this pathway [the movement of 
fruit] requires a combination of biological and climatic conditions 
that are unlikely to occur.'' It is important to acknowledge, as the EU 
scientific opinion did, that there are many possible pathways for the 
introduction of CBS, with some (such as smuggling of nursery stock) 
significantly more likely to result in establishment.
    One commenter asked what circumstances would compel APHIS to 
require further mitigations for CBS in Argentina's packinghouses, and 
what mitigation steps it would be willing to institute in those 
circumstances.
    We have considered the risk of CBS and how to mitigate it. Standard 
packinghouse procedures, including washing, brushing, disinfecting, 
treating, and waxing, address that risk

[[Page 94224]]

effectively. Under the circumstances, we do not believe further 
mitigations are needed.
    One commenter stated that the rule should restrict exports to areas 
of northwest Argentina that are free of CBS.
    For the reasons discussed above, we do not consider this necessary.

Comments on Specific Provisions of the Proposed Rule

    One commenter asked why the Provinces of Catamarca and Jujuy were 
included in the rule when they are not major lemon-producing regions.
    As we explained in the proposed rule, SENASA asked for market 
access for these provinces. We therefore included them in the PRA and 
found that lemons could be safely exported from these provinces subject 
to the conditions described in the proposed rule.
    One commenter stated that Brevipalpus spp. should not be listed as 
quarantine pests, but that citrus leprosis virus should be listed as a 
quarantine pest.
    Citrus leprosis virus is not systemic. It could not be introduced 
into the United States, unless vectored by Brevipalpus spp. mites. For 
this reason we consider the mites to be quarantine pests.
    One commenter stated that the details of the operational workplan 
need to be included in the regulations or otherwise made publicly 
available.
    As we explained above, the mitigations in the operational workplan 
are the same as in the RMD and the rule. The operational workplan 
specifies details for day-to-day operations that are needed to carry 
out provisions of the rule and the RMD. As a result, operational 
workplans are living documents that change periodically to reflect new 
technologies and operational realities in the field.
    One commenter asked what constitutes ``direct involvement'' in 
implementation and monitoring of the operational workplan.
    The operational workplan provides APHIS with the standard operating 
procedures that the NPPO, places of production, packinghouses, and 
others involved in the production of the fruit will follow as part of 
the export program. Our oversight will include routine reviews and 
inspections of the program, but not continual oversight. That would be 
tantamount to mandatory preclearance program, which we do not consider 
necessary. The frequency with which we conduct site visits and review 
export program records will increase if any pest concerns are 
identified.
    One commenter stated that a trust fund agreement to pay for APHIS 
personnel may be necessary.
    A trust fund agreement is associated with preclearance programs in 
which there is continual APHIS oversight, which we do not consider 
warranted here.
    One commenter stated that registration requirements should extend 
to contiguous orchards to mitigate the chance of contamination of the 
place of production during harvest after the initial freedom 
certification.
    APHIS does not consider this to be necessary. As discussed above, 
the Brevipalpus spp. mites that exist in Argentina do not balloon--that 
is they do not produce streamers of silk and travel with wind currents 
for longer distances--and have limited mobility. It is unlikely that 
they could infest contiguous orchards after the initial freedom 
certification.
    One commenter stated that registering small places of production 
may increase pest risk.
    We disagree that small places of production may represent a higher 
pest risk than large ones. In order to be registered with the NPPO and 
participate in the export program, the NPPO (and, as warranted, APHIS) 
must determine that the place of production or packinghouse is able to 
adhere to the systems approach. This is true regardless of the size of 
the place of production or packinghouse. Routine inspections by the 
NPPO, and the possibility of monitoring by APHIS, will corroborate 
ongoing maintenance of systems approach provisions at registered places 
of production and packinghouses.
    We proposed to require lemons from Argentina to be harvested green 
and within the time period of April 1 and August 31. If the lemons are 
harvested yellow or harvested outside of that time period, they would 
have to be treated for Medfly in accordance with 7 CFR part 305 and the 
operational workplan. Two commenters asked how we would determine 
whether a lemon was green or not.
    In the ARS study that determined that lemons are a conditional non-
host of Medfly, the term ``yellow'' was used interchangeably with 
``mature.'' Immature lemons were considered to be a poor host. For 
purposes of the systems approach, we consider any lemon that is not 
green as ripe enough to require cold treatment. We are using additional 
ARS research \8\ and a market standard on lemon color to determine if 
lemons are green.
---------------------------------------------------------------------------

    \8\ Jang, E.B., R.L. Mangan, D.M. Obenland, M.L. Arpaia, and R. 
Rice. (undated). Defining Host Status of California Grown Lemons to 
Fruit Fly Infestation (PowerPoint Presentation). USDA-Agricultural 
Research Service and University of California. 8 pp.
---------------------------------------------------------------------------

    Two commenters asked who will determine whether a lemon is green or 
yellow. One commenter asked where this determination will be made. That 
commenter also stated that APHIS employees should make the 
determination.
    In Argentina, lemons are evaluated for color and graded as part of 
packinghouse procedures. The determination for color and grade is made 
by graders employed by SENASA.
    One commenter stated that the finding that green fruit is harvested 
from March to May in Argentina appears to be based on 2007 information, 
which is outdated.
    When green fruit is harvested in Argentina is irrelevant to the 
conclusions of the PRA. As we explained in the proposed rule, lemons 
that are harvested yellow would have to be treated for Medfly, 
regardless of the time of year in which they are harvested.
    One commenter stated that the RMD and rule should be consistent 
with regard to when lemons do not need treatment.
    The commenter seems to believe that there is a discrepancy between 
the RMD and the proposed rule because the requirement is phrased 
slightly differently, but this is not the case. Both the proposed rule 
and the RMD specify that a lemon must be green and shipped within the 
April-August window in order to avoid treatment.
    One commenter expressed concern that the use of the term 
``safeguarded'' in Sec.  319.56-76(a)(8) is too vague. The commenter 
stated that the words ``and protected from fruit fly infestation'' 
should be inserted after the word ``safeguarded'' in that paragraph.
    APHIS disagrees that this addition is necessary. We use the term 
``safeguarded'' throughout the regulations to mean that fruit must be 
protected from infestation, or, in the case of treated fruit, 
reinfestation, by quarantine pests.
    One commenter asked whether trucks and workers would be sanitized 
in between uses for U.S. exports and other uses, and if not, why not.
    Packinghouse workers are required to wash their hands and wear 
clean protective clothing every time they enter the packinghouse. The 
fruit never touches the trucks; it is harvested and brought to the 
packinghouse in bins that are disinfected after each use. Fruit for

[[Page 94225]]

export is shipped in clean new boxes. Old shipping boxes are never 
reused.
    Several commenters asked how APHIS will determine pest-free places 
of production for B. chilensis, given that Argentine production for 
fresh consumption and processing is intermixed.
    While B. chilensis exists in Argentina, there is no evidence that 
it exists in northwest Argentina. This is based on extensive and 
ongoing documentation SENASA has provided to APHIS. Due to the absence 
of B. chilensis in northwest Argentina, the intermixing of fresh and 
processed production sites in that area does not have a bearing on 
whether a site is pest-free for B. chilensis.
    It is worth noting that we have no evidence that Argentine 
producers designate specific sites for fresh or processed production 
and use different production practices based on the intended use of the 
lemons. Rather, as a result of grading during packinghouse inspections, 
highly graded lots are designated for the fresh market, while the rest 
of the fruit goes to processing and other uses.
    That being said, the rule specifies that APHIS will monitor 
implementation of the systems approach. This includes monitoring the 
distribution of B. chilensis in Argentina. If the distribution changes, 
we note that there are still several safeguards that would address the 
commenter's concern. First, the place of production must be inspected 
regularly by the NPPO of Argentina; these inspections would include 
inspections for B. chilensis. Second, the place of production must 
adhere to any pest control or management practices specified by APHIS 
and/or SENASA. An orchard that was in an area in which B. chilensis is 
known to occur, and in proximity to an orchard not participating in the 
export program, would be subject to management practices to address 
this risk. Finally, registration of places of production allows for 
traceback and quick remediation if infested fruit is discovered later 
in the production chain.
    One commenter stated that APHIS should ask SENASA to prepare a 
grid-type schematic that shows the location of processed orchards as 
compared with orchards where fruit is grown for the fresh export 
market. The commenter stated that this analysis is essential, and that 
if SENASA will not prepare it, then APHIS should prepare it.
    The grid suggested by the commenter is not possible. Orchards in 
Argentina are not designated for a particular type of production. 
Rather, as we explained above, lots are designated based on grading 
conducted in packinghouses.
    Two commenters stated that the biometric sampling protocol for B. 
chilensis is insufficient.
    APHIS disagrees. Mites have limited mobility. The commenters are 
referring to the fact that some species of mites are known to travel 
longer distances by ballooning, where the mites produce streamers of 
silk and travel with wind currents for longer distances. According to 
Childers and Rodrigues (2011), Brevipalpus mites do not produce silk 
and therefore are not capable of ballooning. Childers and Rodrigues 
indicate there is some evidence that these mites can blow from heavily 
infested plants downwind to nearby plants. They do not present evidence 
of long distance movement of Brevipalpus mites by the wind.
    B. chilensis mites in Argentina are associated with the wine grape 
industry in the state of Mendoza (approximately 1,000 miles south of 
the region where lemons are produced). They are not present in 
Tucum[aacute]n where most of the export lemons in Argentina are grown, 
nor, again, is there any evidence of their presence in the whole 
northwestern region.
    The systems approach for B. chilensis is based on the pest's 
limited mobility. This systems approach has similarly been used in 
Chile for citrus for many years without interceptions of this mite in 
commercial shipments. In addition to the place of production 
inspection, every shipment of lemons to be exported will also be 
inspected for mites with the same wash technique. If mites are found on 
any shipment, that place of production will be removed for the rest of 
the export season.
    One commenter stated that APHIS only described the B. chilensis 
protocol, without providing evidence of its adequacy. The commenter 
further stated that the lack of interceptions of the mite on fruit that 
has entered the United States from Chile is not sufficient evidence for 
the effectiveness of the protocol. Another commenter stated that there 
is no literature of evidence that suggests the protocol is effective.
    APHIS disagrees. Mites and other small organisms have been studied 
by collecting them from their habitat through sieves that concentrate 
them. Southwood and Henderson in their classic textbook Ecological 
Methods \9\ devote chapters to this method of sampling.
---------------------------------------------------------------------------

    \9\ Southwood, T.R.E., & Henderson, P.A. (2009). Ecological 
Methods. John Wiley & Sons.
---------------------------------------------------------------------------

    This method of sampling has been used since the 18th century; use 
of Berlese funnels and sieves is ubiquitous in sampling mites and other 
small organisms in various habitats. The agricultural quarantine and 
inspection data that APHIS collects routinely suggests that this 
method, which has been used for almost 20 years by APHIS as a 
mitigation measure, has been very effective in detecting B. chilensis 
mites on fruit from Chile.
    One commenter stated that it is impossible to know whether 100 
samples is sufficient without knowing the size of places of production.
    Regardless of the size of the orchard, 100 samples provides 95 
percent confidence of a 3 percent infestation rate. This confidence 
level is sufficient given that B. chilensis is not known to exist 
within 1,000 miles of northwest Argentina and, biologically, tends to 
aggregate once established. APHIS believes that the overlapping 
protections of routine visual inspections, NPPO surveying for B. 
chilensis spread, and the biometric protocol provide a sufficient 
degree of phytosanitary protection.
    One commenter stated that the B. chilensis biometric sampling 
protocol is not based on the biology of B. chilensis. The commenter 
stated that other species of Brevipalpus are known to have particular 
habitat preferences within a tree, such as the most shaded, humid areas 
(Childers & Rodrigues 2011). The commenter stated that if something 
like this is the case for B. chilensis, then a targeted survey, rather 
than biometric survey of the place of production, is needed to 
determine prevalence.
    APHIS disagrees. Mites, including B. chilensis, reproduce and build 
up populations in a small area because of their limited dispersal 
capability. The sampling distribution is based on the premise that if 
one mite is found, there is a high probability that another mite is 
nearby. This is called an aggregated distribution. This probability 
distribution (or variation), is called hypergeometric, or negative 
binomial, and can be used to model the distribution of most insects and 
mites.
    Very few insects and mites do not have aggregated distributions, 
and there is no evidence that B. chilensis does not have aggregated 
distributions. The production site survey is a targeted survey; the 
samples are taken from the leaves which is where the mite populations 
are highest. We note, moreover, that this survey is presently strictly 
precautionary. There is no evidence of B. chilensis in northwest 
Argentina.
    Two commenters stated that biometric sampling may miss immature B. 
chilensis mites.

[[Page 94226]]

    The mite exists in populations that contain eggs, immature stages, 
and adults. Only the adults can be identified reliably through 
microscopic examination of the filtrate from the sieve. The sieve will 
collect adult mites. The likelihood of only eggs or nymphs being 
present is very low, so APHIS can use the sieve sampling method to 
reliably detect populations of mites at production sites. APHIS will be 
requiring a number of samples and the probability that only eggs and 
larvae of the target mite would be present in all of the samples is 
very low. Moreover, if one sample detects adult B. chilensis mites, the 
production site will not be certified B. chilensis free.
    One commenter asked how APHIS determined the efficacy of Chilean 
citrus protocol.
    As we state in the RMD, our determination was based on the absence 
of detections of infested fruit in the export pathway over almost 20 
years.
    One commenter questioned whether it is appropriate to compare the 
citrus-growing area that exists in Chile to the growing areas in 
Northwest Argentina for purposes of dealing with Brevipalpus spp. 
mites. The commenter noted that the growing area in Argentina is much 
larger than the growing area in Chile, and stated that the growing area 
in Argentina has high rainfall and high humidity, while the growing 
area in Chile typically has low rainfall and low humidity. The 
commenter stated that the difference in climate makes the growing area 
in Argentina hospitable to certain pathogens, but did not specify which 
ones.
    The commenter is mistaken about the climate in northwest Argentina. 
The scientists at the Obispo Columbres Agroindustrial Station, SENASA, 
and the lemon growers in Tucum[aacute]n told us that northwest 
Argentina does not have high rainfall. On the contrary, rainfall is low 
and the lemon groves are often irrigated. Therefore, the mite 
populations should face similar climates in the citrus growing portions 
of Chile and the lemon growing parts of northwest Argentina. During the 
September 2016 site visit, we asked the scientists at the Obispo 
Columbres Agroindustrial station about the mites. They said that they 
had found two of the three Brevipalpus mite species (not B. chilensis) 
in the lemon production areas in northwest Argentina, but that they 
were not common. Further, the hot dry conditions favor mites more than 
rainy humid conditions. The mitigations for Brevipalpus mites should 
not be affected by any climate differences, which appear to be minimal.
    One commenter stated that the protocol for citrus from Chile 
includes species of citrus that may be less hospitable to B. chilensis.
    APHIS notes that the protocol for mites from Chile also includes 
fruit that are better hosts than lemons. The sampling method for 
determining low prevalence works regardless of mite populations on the 
host fruit.
    Two commenters stated that surveying for B. chilensis around 
production sites is necessary because if there are high populations in 
the vicinity, or if wind is a strong factor in dispersal, mites are 
likely to be constantly moving into the orchard.
    As noted above, B. chilensis are a generalist pest, and tend to 
aggregate. The likelihood of B. chilensis in a neighboring orchard, 
without spillover into the registered production site, is low. 
Accordingly, if mites are in the vicinity, they should be detected 
through routine place of production inspections and the biometric 
sampling protocol.
    One commenter stated that the B. chilensis-specific protocol should 
be extended to all Brevipalpus spp. mites.
    Currently Argentina is sampling for B. chilensis and the three 
Brevipalpus spp. mites that are potential vectors for citrus leprosis 
virus. We are only requiring pest free place of production for B. 
chilensis, because B. chilensis is itself a quarantine pest. We are 
requiring consignment freedom (by inspection of harvested fruit) for 
all of the mites. Brevipalpus species other than B. chilensis are only 
considered quarantine pests if they are carrying the citrus leprosis 
virus. The probability of movement of the citrus leprosis pathogen from 
an infected tree in Argentina to a suitable host in the United States 
via a Brevipalpus mite traveling on a lemon fruit is extremely low, and 
require several additional steps to acquire and spread the pathogen so 
we are not requiring production site freedom.
    One commenter stated that the B. chilensis protocol should be 
extended to surrounding areas of production.
    As we explained above, B. chilensis is not found within 1,000 miles 
of northwest Argentina, has low powers of mobility, and tends to 
aggregate. If it is not found in a registered place of production 
during routine surveys conducted by the NPPO to evaluate pest spread, 
as well as routine harvest inspections and two separate biometric 
samples associated with the systems approach, we are confident that it 
will not be on fruit for export.
    One commenter stated that production sites should be inspected for 
B. chilensis throughout the harvest season.
    If mites were found in a consignment at a packinghouse, the 
originating production site would lose its free status. For this reason 
it is not necessary to inspect production sites throughout the harvest 
season.
    One commenter stated that the B. chilensis protocol should include 
surveying for citrus leprosis virus.
    Symptoms of citrus leprosis virus are easy to detect, and fruit 
with such symptoms will be detected during standard packinghouse 
culling and phytosanitary inspections.
    One commenter stated that fallen fruit should be cut and inspected 
for Medfly.
    This effectively calls for place of production freedom for Medfly. 
APHIS notes that in the RMD, fallen fruit are specifically forbidden 
from being included in harvested fruit going to the packinghouse for 
fresh market. For this reason, we do not consider it necessary to 
sample fallen fruit for fruit flies or any other pest.
    One commenter stated that trapping requirements for Medfly need to 
be delineated in the rule itself.
    Historically, we have put trapping requirements in operational 
workplans, rather than rules, to allow flexibility in trapping 
protocols in order to respond to variations in population densities 
from season to season, as well as the development of new lure and bait 
technologies.
    One commenter stated that trapping should be at least 50 percent 
with trimedlure and the other 50 percent should be baited with either 
3-component or protein bait.
    APHIS notes that both the 3-component bait and the protein bait are 
far less powerful lures for fruit flies than trimedlure, a pheromone. 
The trimedlure will draw flies in from farther away and is a more 
sensitive detection system. Trimedlure will also attract males and 
unmated females, which will make up a significant portion of any fruit 
fly population. The only thing that the protein or 3-component baits 
will attract is mated females, and if they are present then males and 
unmated females should also be present and will have already been 
detected by the more powerful trimedlure.
    One commenter asked for greater detail about the requirements for 
packinghouses. The commenter specifically asked whether an entire 
facility would be included as a packinghouse, how many facilities would 
pack lemons for the U.S. market and what volume could a dedicated 
packinghouse expect to process.

[[Page 94227]]

    A packinghouse has to be an entire facility. APHIS is aware of a 
few packinghouses that would serve as primary packinghouses; however, 
all packinghouses would be registered with the NPPO. Both the NPPO and 
APHIS will monitor packinghouses during routine inspections.
    One commenter asked how large a consignment of lemons could be, and 
if there will be a limit on the size of consignments.
    Consignments can vary in size. However, regardless of the size of 
the consignment, the sampling protocol is aimed at detecting a 3 
percent infestation rate with at least 95 percent confidence.
    One commenter asked how a biometric sample was defined.
    The term `biometric sampling' simply means that the sample size 
that is smaller than a straight 2 percent sample can be used to detect 
pests on large consignments of the commodity. Taking a biometric sample 
is more efficient than taking a straight percentage sample.
    One commenter stated that the number of samples inspected should be 
600. The commenter stated that this is consistent with what other 
countries require from U.S. growers.
    APHIS disagrees that the number of samples inspected should be 600. 
One hundred samples is consistent with the Chilean protocol, which has 
been effective at precluding infested fruit from being shipped. 
Inspecting an additional 500 fruit per sample does not substantially 
impact the probability of finding an infestation, and would be 
significantly more resource-intensive.
    One commenter asked if the same method will be used to inspect for 
B. chilensis as is used for the production site protocol.
    Yes, the same method will be used for both production sites and 
packinghouses.
    One commenter asked about the efficacy data for post-harvest 
inspections.
    Post-harvest inspections by the NPPO of an exporting country are a 
long-standing phytosanitary measure that APHIS employs as part of 
market access requirements. The safe importation of thousands of 
foreign commodities into the United States over a prolonged period of 
time is an indication of its efficacy as a phytosanitary measure.
    One commenter stated that fruit that is infested with Medfly larvae 
should be prohibited from being shipped.
    APHIS disagrees. In the event that a single immature Medfly is 
found in or with the lemons, then the lemons must be treated in 
accordance with part 305 of the regulations and the operational 
workplan using a cold treatment. This cold treatment has been shown to 
be effective at mitigating the risk of Medfly in lemons. Additionally, 
the registered place of production that produced the lemons in the 
consignment may be suspended from the export program, pending an 
investigation.
    One commenter stated that remedial actions should be identical, 
regardless of quarantine pest detected.
    The remedial action when quarantine pests are detected is that the 
fruit cannot be exported. Some findings of quarantine pests also 
disqualify production sites because the mitigation requires the 
production site to be a pest-free place of production.
    One commenter noted that the rule referred to CBP inspectors, but 
the supporting documents refer to APHIS inspectors. The commenter asked 
for clarification as to who will conduct port of entry inspections.
    CBP conducts inspections at ports of entries pursuant to authority 
delegated to APHIS. The use of CBP employees to carry out functions 
specifically delegated to APHIS is authorized by the Homeland Security 
Act of 2002. Because CBP is effectively acting as agents of APHIS for 
the purposes of these inspections, we use the term ``APHIS.'' These 
inspections sample imported commodities for evidence of pests. If pests 
are detected, APHIS identifiers will be used to positively identify the 
pests.
    One commenter asked whether port of entry inspections would include 
biometric sampling for Brevipalpus mites. The commenter also asked how 
CBP would be able to detect the mites.
    The B. chilensis protocol is used to establish place of production 
freedom, and is also used as part of the phytosanitary inspection by 
the NPPO. Port of entry inspection for B. chilensis and other 
Brevipalpus mites will look for the pests, as well as signs and 
symptoms of infestation, such as bronzing.
    One commenter asked why, if information from port of entry 
inspections is ``unreliable,'' they can be stated to be effective.
    ``Not be detected at the port of entry'' was removed as a criterion 
in the PRA because we do not have enough information about relative 
likelihood of detection at the port of entry to be able to weight this 
criterion relative to other elements. As a result, this criterion could 
not substantially impact the risk ratings. This does not imply that 
port of entry inspections are an ineffective component of a systems 
approach.
    One commenter stated that the rule should specify how APHIS will 
monitor and enforce the systems approach. The commenter expressed 
concern that APHIS would have to commit substantial resources to ensure 
compliance with the operational workplan.
    This request is predicated on the stated assumptions that SENASA 
lacks the ability and intent to abide by systems approach requirements. 
For reasons discussed above, we disagree with those assumptions.
    One commenter stated that APHIS should require cold treatment of 
lemons from northwest Argentina.
    This approach would not impose the least restrictive science-based 
actions needed to address plant pest risk, and thus would be 
inconsistent with our obligations under the SPS agreement.
    One commenter stated that the rule should prohibit the importation 
of lemons from northwest Argentina into Florida. The commenter also 
stated that the rule should limit importation of lemons to areas north 
of the 38th parallel.
    We have determined, for the reasons described in the RMD that 
accompanied the proposed rule, that the measures specified in the RMD 
will effectively mitigate the risk associated with the importation of 
lemons from northwest Argentina. The commenter did not provide any 
evidence suggesting that the mitigations are not effective. Therefore, 
we are not taking the action requested by the commenter.
    Two commenters expressed concern that Argentine producers may use 
pesticides or practices that are not authorized in the United States.
    We note that the Food and Drug Administration (FDA) of the 
Department of Health and Human Services regulates the pesticide, 
herbicide, and fertilizer residues that may be present on imported 
fruits and vegetables intended for human consumption. If illegal 
pesticides are detected, FDA will take action to remove them from the 
marketplace. Additionally, we note that the packinghouse disinfectants 
and treatments for pathogens that we are proposing for Argentina are 
the same used domestically.
    One commenter stated that importing lemons from Argentina will 
involve carbon dioxide emissions that should be available to the 
consumer as they purchase the lemons. The commenter stated that the 
lemons should be labeled with the pounds of carbon dioxide emitted per 
pound of lemons.
    This request is outside the scope of APHIS' statutory authority.

[[Page 94228]]

    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with minor 
editorial changes.

Executive Order 12866 and Regulatory Flexibility Act

    This final rule has been determined to be not significant for the 
purposes of Executive Order 12866 and, therefore, has not been reviewed 
by the Office of Management and Budget.
    In accordance with 5 U.S.C. 604, we have performed a final 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this rule on small entities. Copies of the full 
analysis are available on the Regulations.gov Web site (see footnote 1 
in this document for a link to Regulations.gov) or by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT.
    This analysis examines potential economic impacts of a rule that 
will allow the importation of fresh lemons from a region in Northwest 
Argentina into the continental United States. A systems approach to 
pest risk mitigation will provide phytosanitary protection against 
pests of quarantine concern. Both U.S. producers and consumers will be 
affected by the rule. While producers' welfare will be negatively 
affected, welfare gains for consumers will outweigh producer losses, 
resulting in a net benefit to the U.S. economy.
    Commercial lemon production takes place in California and Arizona. 
For the 2014/15 season, lemon-bearing acres totaled 55,300 (California 
47,000, Arizona 8,300). In the same season, the value of U.S. 
production of lemons was $694 million. Over the production seasons 
2008/09 to 2014/15, U.S. fresh lemon production averaged 535,244 metric 
tons (MT) per year. Over the same period, annual imports averaged 
49,995 MT and exports averaged 101,849 MT. Because lemons imported from 
Argentina that are harvested green between April 1 and August 31 will 
not require treatment for Medfly, we expect that most will be imported 
during this period, which coincides roughly with the months in which 
U.S. lemon exports are declining and imports are increasing.
    Effects of the rule are estimated using a partial equilibrium model 
of the U.S. lemon sector. Annual imports of fresh lemon from Argentina 
are expected to range between 15,000 and 20,000 MT, with volumes 
averaging 18,000 MT. Quantity, price and welfare changes are estimated 
for these three import scenarios.
    If the United States imports 18,000 MT of fresh lemon from 
Argentina and there is no displacement of lemon imports from other 
countries, we estimate that the price (custom import value) of fresh 
lemon will decrease by about 4 percent. Consumer welfare gains of $22.4 
million will outweigh producer welfare losses of $19.9 million, 
resulting in a net welfare gain of $2.5 million. The 15,000 MT and 
20,000 MT scenarios show similar effects.
    More reasonably, partial import displacement will occur, and price 
and welfare effects will be proportional to the net increase in U.S. 
lemon imports. Assuming as an upper-bound that one-half of the quantity 
of fresh lemons imported from Argentina displaces U.S. fresh lemon 
imports from elsewhere, we estimate for the 18,000 MT scenario that the 
price decline will be about 2 percent; consumer welfare gains and 
producer welfare losses will be $11.1 million and $10.0 million, 
respectively, yielding a net welfare benefit of $1.1 million.
    The majority of businesses that may be affected by the final rule 
are small entities, including lemon producers, packers, wholesalers, 
and related establishments.

Executive Order 12988

    This final rule allows lemons to be imported into the continental 
United States from Argentina. State and local laws and regulations 
regarding lemons imported under this rule will be preempted while the 
fruit is in foreign commerce. Fresh lemons are generally imported for 
immediate distribution and sale to the consuming public, and remain in 
foreign commerce until sold to the ultimate consumer. The question of 
when foreign commerce ceases in other cases must be addressed on a 
case-by-case basis. No retroactive effect will be given to this rule, 
and this rule will not require administrative proceedings before 
parties may file suit in court challenging this rule.

Paperwork Reduction Act

    In accordance with section 3507(d) of the Paperwork Reduction Act 
of 1995 (44 U.S.C. 3501 et seq.), the information collection or 
recordkeeping requirements included in this final rule, which were 
filed under 0579-0448, have been submitted for approval to the Office 
of Management and Budget (OMB). When OMB notifies us of its decision, 
if approval is denied, we will publish a document in the Federal 
Register providing notice of what action we plan to take.

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 rule, please contact Ms. Kimberly Hardy, 
APHIS' Information Collection Coordinator, at (301) 851-2483.

List of Subjects for 7 CFR Part 319

    Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant 
diseases and pests, Quarantine, Reporting and recordkeeping 
requirements, Rice, Vegetables.

    Accordingly, we are amending 7 CFR part 319 as follows:

PART 319--FOREIGN QUARANTINE NOTICES

0
1. The authority citation for part 319 continues to read as follows:

    Authority:  7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.


0
2. Section 319.28 is amended as follows:
0
a. In paragraph (a)(1), by removing the words ``(except for the States 
of Catamarca, Jujuy, Salta, and Tucuman, which are considered free of 
citrus canker)''.
0
b. In paragraph (a)(2), by removing the word ``Argentina,''.
0
c. By redesignating paragraphs (e) through (i) as paragraphs (f) 
through (j), respectively, and adding a new paragraph (e).
0
d. In newly redesignated paragraph (h), the words ``paragraphs (b) 
through (e)'' are removed and the words ``paragraphs (b) through (f)'' 
are added in their place.
    The addition reads as follows:


Sec.  [thinsp]319.28  Notice of quarantine.

* * * * *
    (e) The prohibition does not apply to lemons (Citrus limon (L.) 
Burm. f.) from northwest Argentina that meet the requirements of Sec.  
[thinsp]319.56-76.
* * * * *

0
3. Section 319.56-76 is added to read as follows:


Sec.  [thinsp]319.56-76  Lemons from northwest Argentina.

    Fresh lemons (Citrus limon (L.) Burm. f.) may be imported into the 
continental United States from northwest Argentina (the Provinces of 
Catamarca, Jujuy, Salta, and Tucum[aacute]n) only under the conditions 
described in this section. These conditions are designed to prevent the 
introduction of the

[[Page 94229]]

following quarantine pests: Brevipalpus chilensis, the Chilean false 
red mite; B. californicus, the citrus flat mite, B. obovatus, the 
scarlet tea mite, and B. phoenicis, the false spider mite (referred to 
in this section as ``Brevipalpus spp. mites''); Ceratitis capitata, the 
Mediterranean fruit fly; Cryptoblabes gnidiella, the honeydew moth; 
Elsino[euml] australis, the causal agent of sweet orange scab disease; 
Gymnandrosoma aurantianum (Lima), the citrus borer; and Xanthomonas 
citri subsp. citri (ex Hasse) Gabriel et al., the causal agent of 
citrus canker disease.
    (a) General requirements--(1) Operational workplan. The national 
plant protection organization (NPPO) of Argentina must provide an 
operational workplan to APHIS that details the activities that the NPPO 
of Argentina and places of production and packinghouses registered with 
the NPPO of Argentina will, subject to APHIS' approval of the workplan, 
carry out to meet the requirements of this section. The operational 
workplan must include and describe the specific requirements as set 
forth in this section. APHIS will be directly involved with the NPPO of 
Argentina in monitoring and auditing implementation of the systems 
approach.
    (2) Registered places of production. The fresh lemons considered 
for export to the continental United States must be grown by places of 
production that are registered with the NPPO of Argentina and that have 
been determined to be free from B. chilensis in accordance with this 
section.
    (3) Registered packinghouses. The lemons must be packed for export 
to the continental United States in pest-exclusionary packinghouses 
that are registered with the NPPO of Argentina.
    (4) Recordkeeping. The NPPO of Argentina must maintain all forms 
and documents pertaining to registered places of production and 
packinghouses for at least 1 year and, as requested, provide them to 
APHIS for review. Based on APHIS' review of records, APHIS may monitor 
places of production and packinghouses, as APHIS deems warranted.
    (5) Commercial consignments. Lemons from Argentina can be imported 
to the continental United States in commercial consignments only. For 
purposes of this section, fruit in a commercial consignment must be 
practically free of leaves, twigs, and other plant parts, except for 
stems less than 1 inch long and attached to the fruit.
    (6) Identification. The identity of the each lot of lemons from 
Argentina must be maintained throughout the export process, from the 
place of production to the arrival of the lemons at the port of entry 
into the continental United States. The means of identification that 
allows the lot to be traced back to its place of production must be 
authorized by the operational workplan.
    (7) Harvesting restrictions or treatment for fruit flies. Lemons 
from Argentina must be harvested green and within the time period of 
April 1 and August 31. If they are harvested yellow or harvested 
outside of this time period, they must be treated for C. capitata in 
accordance with part 305 of this chapter and the operational workplan.
    (8) Safeguarding. Lots of lemons destined for export to the 
continental United States must be safeguarded during movement from 
registered places of production to registered packinghouses as 
specified by the operational workplan.
    (9) Phytosanitary certificate. Each consignment of lemons imported 
from Argentina into the continental United States must be accompanied 
by a phytosanitary certificate issued by the NPPO of Argentina with an 
additional declaration stating that the requirements of this section 
have been met and that the consignments have been inspected and found 
free of Brevipalpus spp. mites, B. chilensis, C. capitata, C. 
gnidiella, and G. aurantianum.
    (b) Place of production requirements. (1) Prior to each harvest 
season, registered places of production of lemons destined for export 
to the continental United States must be determined by APHIS and the 
NPPO of Argentina to be free from B. chilensis based on biometric 
sampling conducted in accordance with the operational workplan. If a 
single live B. chilensis mite is discovered as a result of such 
sampling, the place of production will not be considered free from B. 
chilensis and will not be able to export lemons to the United States. 
Each place of production will have only one opportunity per harvest 
season to be considered free of B. chilensis, and certification of B. 
chilensis freedom will only last one harvest season.
    (2) Places of production must remove plant litter and fallen debris 
from groves in accordance with the operational workplan. Fallen fruit 
may not be included in field containers of fruit brought to the 
packinghouse to be packed for export.
    (3) Places of production must trap for C. capitata in accordance 
with the operational workplan. The NPPO must keep records regarding the 
placement and monitoring of all traps, as well as records of all pest 
detections in these traps, and provide the records to APHIS, as 
requested.
    (4) Places of production must carry out any additional grove 
sanitation and phytosanitary measures specified for the place of 
production by the operational workplan.
    (5) The NPPO of Argentina must visit and inspect registered places 
of production regularly throughout the exporting season for signs of 
infestations. These inspections must start no more than 30 days before 
harvest and continue until the end of the export season. The NPPO of 
Argentina must allow APHIS to monitor these inspections. The NPPO of 
Argentina must also provide records of pest detections and pest 
detection practices to APHIS. Before any place of production may export 
lemons to the continental United States pursuant to this section, APHIS 
must review and approve of these practices.
    (6) If APHIS or the NPPO of Argentina determines that a registered 
place of production has failed to follow the requirements in this 
paragraph (b), the place of production will be excluded from the export 
program until APHIS and the NPPO of Argentina jointly agree that the 
place of production has taken appropriate remedial measures to address 
the plant pest risk.
    (c) Packinghouse requirements. (1) During the time registered 
packinghouses are in use for packing lemons for export to the 
continental United States, the packinghouses may only accept lemons 
that are from registered places of production and that have been 
produced in accordance with the requirements of this section.
    (2) Lemons destined for export to the continental United States 
must be packed within 24 hours of harvest in a registered pest-
exclusionary packinghouse or stored in a degreening chamber in the 
registered pest-exclusionary packinghouse. Lemons must be packed for 
shipment to the continental United States in insect-proof cartons or 
containers, or covered with insect-proof mesh or plastic tarpaulin. 
These safeguards must remain intact until the lemons arrive in the 
United States, or the consignment will not be allowed to enter the 
United States.
    (3) Prior to packing, the lemons must be washed, brushed, and 
surface disinfected for E. australis and X. citri and in accordance 
with the operational workplan, treated with an APHIS-approved 
fungicide, and waxed.
    (4) After treatment, the NPPO of Argentina or officials authorized 
by the NPPO of Argentina must visually inspect a biometric sample of 
each consignment for quarantine pests, wash

[[Page 94230]]

the lemons in this sample, and inspect the filtrate for B. chilensis in 
accordance with the operational workplan. A portion of the lemons must 
then be cut open and inspected for evidence of quarantine pests.
    (i) If a single C. gnidiella or G. aurantianum in any stage of 
development is found on the lemons, the entire consignment is 
prohibited from export to the United States, and the registered place 
of production that produced the lemons is suspended from the export 
program until APHIS and the NPPO of Argentina jointly agree that the 
place of production has taken appropriate remedial measures to address 
plant pest risk.
    (ii) If a single B. chilensis or Brevipalpus spp. mite in any stage 
of development is found on the lemons, the entire consignment is 
prohibited from export, and the registered place of production that 
produced the lemons may be suspended from the export program, pending 
an investigation.
    (iii) If a single immature Medfly is found in or with the lemons, 
the lemons must be treated in accordance with part 305 of this chapter 
and the operational workplan. Additionally, the registered place of 
production that produced the lemons in the consignment may be suspended 
from the export program, pending an investigation.
    (5) If APHIS or the NPPO of Argentina determines that a registered 
packinghouse has failed to follow the requirements in this paragraph 
(c), the packinghouse will be excluded from the export program until 
APHIS and the NPPO of Argentina jointly agree that the packinghouse has 
taken appropriate remedial measures to address the plant pest risk.
    (d) Port of entry requirements. Consignments of lemons from 
Argentina will be inspected at the port of entry into the United 
States. If any quarantine pests are discovered on the lemons during 
inspection, the entire lot in which the quarantine pest was discovered 
will be subject to appropriate remedial measures to address this risk.

(Approved by the Office of Management and Budget under control 
number 0579-0448)

    Done in Washington, DC, this 20th day of December 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-31013 Filed 12-22-16; 8:45 am]
 BILLING CODE 3410-34-P