[Federal Register Volume 83, Number 67 (Friday, April 6, 2018)]
[Rules and Regulations]
[Pages 14733-14736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07073]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 
 ========================================================================
 

  Federal Register / Vol. 83, No. 67 / Friday, April 6, 2018 / Rules 
and Regulations  

[[Page 14733]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2015-0051]
RIN 0579-AE20


Importation of Lemons From Chile Into the Continental United 
States

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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

SUMMARY: We are amending the fruits and vegetables regulations to list 
lemon (Citrus limon (L.) Burm. f.) from Chile as eligible for 
importation into the continental United States subject to a systems 
approach. Under this systems approach, the fruit will have to be grown 
in a place of production that is registered with the Government of 
Chile and certified as having a low prevalence of Brevipalpus 
chilensis. The fruit will have to undergo pre-harvest sampling at the 
registered production site under the direction of Chile's national 
plant protection organization. Following post-harvest processing, the 
fruit will have to be inspected in Chile at an APHIS-approved 
inspection site. Each consignment of fruit will have to be accompanied 
by a phytosanitary certificate with an additional declaration stating 
that the fruit had been found free of B. chilensis based on field and 
packinghouse inspections. This final rule will allow for the safe 
importation of lemons from Chile using mitigation measures other than 
fumigation with methyl bromide.

DATES: Effective May 7, 2018.

FOR FURTHER INFORMATION CONTACT: Ms. Dorothy Wayson, Senior Regulatory 
Specialist, Regulatory Coordination and Compliance, Plant Health 
Programs, PPQ, APHIS, 4700 River Road, Unit 133, Riverdale, MD 20737; 
(301) 851-2036.

SUPPLEMENTARY INFORMATION: 

Background

    Under the regulations in ``Subpart-Fruits and Vegetables'' (7 CFR 
319.56-1 through 319.56-82, referred to below as the regulations), the 
Animal and Plant Health Inspection Service (APHIS) of the United States 
Department of Agriculture prohibits or restricts the importation of 
fruits and vegetables into the United States from certain parts of the 
world to prevent plant pests from being introduced into and spread 
within the United States.
    The regulations in Sec.  319.56-4(a) provide that fruits and 
vegetables that can be safely imported using one or more of the 
designated phytosanitary measures in Sec.  319.56-4(b) will be listed, 
along with the applicable requirements for their importation, on the 
internet. This list may be found in the Fruits and Vegetables Import 
Requirements (FAVIR) database at https://www.aphis.usda.gov/aphis/ourfocus/planthealth/sa_import/sa_permits/sa_plant_plant_products/sa_fruits_vegetables/ct_favir/. Currently, lemons from Chile (Citrus 
limon (L.) Burm. f.) are listed in the FAVIR database as enterable 
subject to treatment with methyl bromide for the pest Brevipalpus 
chilensis, the Chilean false red mite, applied either as a condition of 
entry treatment or in Chile under an APHIS preclearance program. These 
conditions have been in place since 1982.
    The regulations in Sec.  319.56-4(a) also provide that commodities 
that require phytosanitary measures other than those found in Sec.  
319.56-4(b) may only be imported in accordance with applicable 
requirements in Sec.  319.56-3 and commodity-specific requirements 
contained elsewhere in the subpart. The conditions applicable to the 
importation of citrus from Chile are listed in Sec.  319.56-38. At 
present, clementines (Citrus reticulata Blanco var. Clementine), 
mandarins (Citrus reticulata Blanco), and tangerines (Citrus reticulata 
Blanco) may be imported into the United States from Chile, and 
grapefruit (Citrus paradisi Macfad.) and sweet oranges (Citrus sinensis 
(L.) Osbeck) may be imported into the continental United States from 
Chile under a systems approach.
    On April 4, 2016, we published in the Federal Register (81 FR 
19063-19066, Docket No. APHIS-2015-0051) a proposal \1\ to amend Sec.  
319.56-38 by including lemons that are currently enterable into the 
United States subject to treatment, thereby making the lemons eligible 
for importation under the same systems approach as other citrus from 
Chile. We also prepared a commodity import evaluation document (CIED) 
in support of the proposed rule. The CIED was made available for public 
review and comment with the proposed rule.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, the supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0051.
---------------------------------------------------------------------------

    We solicited comments concerning our proposal for 60 days ending 
June 3, 2016. During that time, a commenter noted that APHIS prepared a 
pest risk assessment (PRA) in response to this market request in 2012, 
but while we made it available to stakeholders, we did not publish a 
notice in the Federal Register making the PRA available for public 
review and comment. In response, we made the 2012 PRA publicly 
available and reopened and extended the deadline for comments until 
September 26, 2016, in a document published in the Federal Register on 
August 26, 2016 (81 FR 58873, Docket No. APHIS-2015-0051). We received 
38 comments by that date. They were from producers, importers, 
exporters, port operators, representatives of State and foreign 
governments, and private citizens. Twenty-eight of the commenters were 
supportive of the proposed rule. The other commenters raised a number 
of questions and concerns about the proposed rule. The comments are 
discussed below, by topic.
    One commenter was opposed to the proposed rule because of potential 
economic impacts on lemon producers in the United States.
    APHIS notes that the United States is already a net importer of 
lemons. We also note that this final rule will not change the number of 
lemons produced by Chile for export to the United States, but will 
provide an alternative to methyl bromide fumigation. We have thoroughly 
analyzed the economic effects of the rule, as described below.
    Two commenters stated that they were opposed to the proposed rule 
because there would be an increased pest risk associated with lemons 
produced under a systems approach.

[[Page 14734]]

    APHIS notes that this systems approach has been used successfully 
with other commodities, such as grapefruit, oranges, and tangerines, to 
prevent the introduction of pests associated with citrus from Chile. We 
are making no changes in response to this comment.
    One commenter stated that the detection methodology used to qualify 
for the systems approach will only detect adult mites as a 200 mesh 
sieve (0.074 mm) but will not collect immature mites. The commenter 
stated that a refinement of this methodology by using a mesh size of 
0.044 mm is needed to detect all life stages.
    The commenter is correct that the sieve will collect adult mites. 
Only the adults can be identified reliably through microscopic 
examination of the filtrate from the sieve. However, in a given 
population, multiple life stages (egg to adult) of the mite are 
concurrent, and since APHIS will require a number of samples, the 
likelihood of only eggs or nymphs being present in all of the samples 
is very low. For this reason APHIS can use the sieve sampling method to 
reliably detect populations of mites at production sites.
    Three commenters noted that if mites are detected, lemons would not 
qualify for the systems approach but could still be shipped to the 
United States if a methyl bromide treatment is conducted at either the 
point of origin or at destination. The commenters stated that the 
treatment of lemons using methyl bromide in Florida is unacceptable as 
this will allow for the possibility of mites to have a pathway into 
Florida and possibly endanger Florida's citrus and grape industries. 
One of the commenters stated that all shipments of fresh lemons that do 
not qualify for shipment under the systems approach should either have 
the methyl bromide treatment conducted in Chile or have the shipments 
sent north of the 39th parallel.
    The commenters are correct that lemons that do not qualify for the 
systems approach could still be shipped to the United States if they 
are treated with methyl bromide. However, APHIS disagrees that 
treatment of lemons in Florida will provide a pathway for B. chilensis 
into Florida. We have determined, for the reasons described in the CIED 
that accompanied the proposed rule, that the measures specified in the 
systems approach will effectively mitigate the risk associated with the 
importation of lemons from Chile. 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.
    One commenter suggested substituting phosphine (sold under the 
trade names Phostoxin and Magtoxin) or a phosphine/carbon dioxide 
combination in place of methyl bromide fumigation.
    APHIS notes that we do not have an approved phosphine treatment for 
B. chilensis. Moreover, Chile did not ask APHIS to approve a phosphine 
treatment. They requested that we approve a systems approach, which can 
substitute for a methyl bromide treatment, eliminating the need for 
fumigation.
    One commenter stated that the rule provides that the production 
centers where lemons are grown must be registered with the national 
plant protection organization (NPPO) of Chile including in this record 
the number of plants/hectares/species. The commenter suggested that 
this be replaced by the area in hectares/species/variety, which is the 
information that we currently manage in our records for the other 
citrus species under a systems approach.
    APHIS disagrees. Under the regulations, production site 
registration requires: Production site name, grower, municipality, 
province, region, area planted to each species, number of plants/
hectares/species, and approximate date of harvest. The information 
required in this rulemaking is consistent with current recordkeeping 
for other citrus from Chile under a systems approach.
    In the proposed rule and the accompanying CIED, we referred to 
commercially grown shipments from registered production sites that use 
good agricultural practices to reduce or eliminate pests. One commenter 
asked what good agricultural practices entail.
    In this context, the phrase good agricultural practices means that 
fruits and vegetables are produced, packed, handled, and stored to 
reduce or eliminate pest risk by growing healthy crops that are less 
vulnerable to pest and diseases, and by protecting the fruit from 
exposure to pests and diseases after harvest. Good agricultural 
practices can effectively suppress or eliminate pests from fields or 
prevent infestation in harvested crops.
    One commenter stated that the requirement for good agricultural 
practices should be required for pre-harvest as well as post-harvest 
protocols. The commenter suggested adding the words ``Production sites 
must follow pre-harvest good agricultural practices to be registered'' 
to Sec.  319.56-38(d)(1).
    APHIS notes that following pre-harvest good agricultural practices 
is not currently required for other Chilean citrus using the systems 
approach. Furthermore, the systems approach will disqualify production 
sites that, upon inspection, are found to have mites. It is up to the 
Chilean growers to reduce their mite populations or they will not 
qualify to export under the systems approach.
    One commenter asked if APHIS will have any role in pre-harvest 
oversight activities, such as reviewing the records for the 
registrations on an annual basis. The commenter also asked if APHIS 
personnel will participate in the pre-harvest tests that are done to 
determine the existence of the mite.
    Yes. At Chile's request, APHIS conducts activities in Chile under a 
pre-clearance program that covers all fruits and vegetables exported to 
the United States, so all of the pre-harvest tests and sampling are 
subject to APHIS oversight. More information about APHIS pre-clearance 
activities can be found on the APHIS website at https://www.aphis.usda.gov/aphis/ourfocus/planthealth/import-information/sa_preclearance/ct_preclearance_activities.
    One commenter asked how large registered production sites would be. 
The commenter stated that the size of the random sample should be 
proportionate to the size of the registered site. The commenter also 
asked if there would be a maximum size for each registered production 
site.
    APHIS does not place limits on the size of production sites. The 
samples for determining freedom from mites are to be taken at random 
from production sites. Random sampling obviates any reason to increase 
sample size with the size of the production site. The current sample 
size is sufficient to detect mite populations of 2 percent with 95 
percent probability regardless of the size of production sites.
    One commenter stated that requiring the NPPO of Chile to present a 
list of certified production sites to APHIS annually is insufficient 
because the pest situation in a given area is always evolving.
    Production site surveillance is not the only method used to detect 
pests. Packinghouse inspection, which takes place throughout the 
harvest season, backs up production site surveillance. These 
overlapping measures are part of the same systems approach that has 
been successfully used with other commodities, such as grapefruit, 
oranges, and tangerines from Chile, to prevent pest introductions into 
the United States.

[[Page 14735]]

    Two commenters stated that in the 2012 PRA, B. chilensis was rated 
as medium risk. The commenters stated that the pest should be 
considered high risk.
    APHIS disagrees that the pest should be rated as high risk. 
Furthermore, a high risk rating would not have changed our mitigations 
for the pest. 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 B. chilensis 
are based on the possibility that it may follow the pathway, rather 
than the risk rating ascribed to the pests.
    One commenter stated that random sampling may not be the 
appropriate way to determine its prevalence in a given growing area. 
Instead, surveys of surrounding areas may be needed because if there 
are populations of the mite in the vicinity of the production site and 
given the ability of the mite to travel on the wind, the mites could 
move into neighboring orchards given the right wind conditions.
    B. chilensis tend to aggregate, move downwind slowly, and do not 
balloon--that is, they do not produce streamers of silk and travel with 
wind currents for longer distances.\2\ If B. chilensis mites move from 
a neighboring orchard into a registered production site, they should be 
readily detected through routine place of production inspections and 
the biometric sampling protocol.
---------------------------------------------------------------------------

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

    One commenter stated that the 2012 PRA should have addressed citrus 
fruit borer (Gymnandrosoma aurantianum), which is present in Argentina, 
Peru, and Brazil.
    The PRA addressed pests of lemons that are present in Chile. The 
Crop Protection Compendium \3\ maintained by the Centre for Agriculture 
and Biosciences International does not list the citrus fruit borer as 
present in Chile, and a search of the scientific literature for 
Tortricidae references did not find it to be present in Chile.
---------------------------------------------------------------------------

    \3\ The Crop Protection Compendium can be viewed online at 
http://www.cabi.org/cpc/.
---------------------------------------------------------------------------

    One commenter stated that APHIS should provide data that 
demonstrates that the pre-harvest sieving is effective. The commenter 
stated that relying on the lack of interceptions of the mite is not 
sufficient.
    As we explained above, this systems approach, including pre-harvest 
sieving, has been used successfully with other commodities, such as 
clementines, mandarins, tangerines, grapefruits, and sweet oranges from 
Chile. APHIS considers that this approach has been extensively tested 
and found to work.
    Two commenters stated that the wash survey proposed in the systems 
approach does not appear to have been evaluated in scientific 
literature. The commenters stated that surveys capable of detecting 
immature mites should be scientifically evaluated before being 
considered as a component of a systems approach.
    APHIS disagrees. Mites and other small organisms have been studied 
by collecting them from their habitat through sieves that concentrate 
them. In their classic textbook Ecological Methods, Southwood and 
Henderson devote chapters to this method of sampling. (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 the 
specific method described in the regulations, which has been used for 
almost 20 years, has been very effective in detecting B. chilensis 
mites on fruit from Chile.
    One commenter noted that under the systems approach, a biometric 
sample of each consignment will be inspected in Chile under the 
direction of APHIS inspectors. The commenter asked how the term 
biometric sample is defined and if the biometric sample will be made 
proportional to the size of the consignment. The commenter also asked 
how large each consignment would be and if there was a limit on the 
size of each consignment.
    With a hypergeometric probability distribution (biometric sample), 
once a certain consignment size is reached (about 4,000 fruit, which 
would be a very small commercial shipment), a fixed sample size of 150 
gives the same probability of finding the pest (95 percent confidence 
of finding a 2 percent pest infestation) independent of the increasing 
consignment size no matter how large the consignment size is. The size 
of a consignment is determined by agreement between the importer and 
the exporter. APHIS does not limit the size of consignments.
    One commenter stated that the number of samples inspected for the 
determination of production site freedom from mites as part of the 
systems approach should be 600 for at least the first 3 years of the 
program, since this is consistent with what other countries require of 
U.S. growers. The commenter stated that this requirement is appropriate 
given that this is the first time this program has been applied to 
lemons and unanticipated issues could arise.
    APHIS disagrees that the number of samples inspected should be 600. 
One hundred samples is consistent with the protocol used for other 
Chilean citrus fruits, including clementines, mandarins, tangerines, 
grapefruits, and sweet oranges, and has been effective at preventing 
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.

Miscellaneous

    In Sec.  319.56-38, paragraph (d)(4) provides the phytosanitary 
inspection procedures that apply to citrus fruit imported from Chile 
under the section. When we added sweet oranges and grapefruit to the 
section in 2009, we failed to add them specifically to that paragraph 
with the already-listed clementines, mandarins, and tangerines. We 
similarly neglected to propose adding lemons to the listed fruit in our 
proposed rule. Therefore, in this final rule, we have added sweet 
oranges, grapefruit, and lemons to the fruit listed in paragraph 
(d)(4).
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
change discussed in this document.

Executive Orders 12866 and 13771 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. Further, because this final 
rule is not significant, it is not a regulatory action under Executive 
Order 13771.
    In accordance with the Regulatory Flexibility Act, we have analyzed 
the potential economic effects of this action on small entities. The 
analysis is summarized below. Copies of the full analysis are available 
on the Regulations.gov website (see footnote 1 in this document for a 
link to Regulations.gov) or by contacting the person listed under FOR 
FURTHER INFORMATION CONTACT.
    This rule will allow fresh lemon imported from Chile into the 
United States to be treated using a systems approach as an alternative 
to methyl bromide fumigation, to mitigate the risk of introduction of 
the Chilean false red mite.

[[Page 14736]]

    The United States is a net importer of fresh lemons. Over the last 
five seasons, U.S. annual imports of fresh lemons averaged 497,000 
metric tons (MT), an amount equal to about 60 percent of U.S. fresh 
lemon production and almost four times the quantity exported (129,000 
MT per year).
    More than 90 percent of U.S. fresh lemon imports come from Mexico, 
with only 4 percent supplied by Chile. Chile's Ministry of Agriculture 
estimates that approximately 60 percent of that country's lemon exports 
to the United States will be qualified for importation using the 
systems approach rather than fumigated. This amount represents less 
than 3 percent of U.S. lemon imports, and less than 2 percent of U.S. 
fresh lemon consumption. This rule is not expected to result in 
significant cost savings for Chile's lemon exporters or a substantial 
change in their competitiveness.
    Although the majority of entities that may be affected by this rule 
(lemon importers, producers, and wholesalers) are small, the 
Administrator of the Animal and Plant Health Inspection Service has 
determined that this rule will not have a significant economic impact 
on a substantial number of small entities.

Executive Order 12988

    This final rule allows lemon fruit to be imported into the 
continental United States from Chile subject to a systems approach. 
State and local laws and regulations regarding lemon fruit imported 
under this rule will be preempted while the fruit is in foreign 
commerce. Fresh fruits 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 burden requirements included in 
this final rule, which were filed under 0579-0446, 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 in 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 and 7701-7772 and 7781-7786; 21 U.S.C. 
136 and 136a; 7 CFR 2.22, 2.80, and 371.3.


0
 2. Section 319.56-38 is amended as follows:
0
 a. In the introductory text, by adding the words ``, lemons (Citrus 
limon (L.) Burm. f.),'' between the words ``(Citrus paradisi Macfad.)'' 
and ``and sweet oranges'';
0
 b. In paragraph (d)(4) introductory text, by adding the words 
``grapefruit, lemons,'' between the words ``Clementines,'' and 
``mandarins,'' and by adding the words ``sweet oranges,'' between the 
words ``mandarins,'' and ``or tangerines'';
0
c. In paragraphs (e) and (f), by adding the word ``lemons,'' between 
the words ``grapefruit,'' and ``mandarins,''; and
0
 d. By revising the OMB citation at the end of the section.
    The revision reads as follows:


Sec.  319.56-38  Citrus from Chile.

* * * * *

    (Approved by the Office of Management and Budget under control 
numbers 0579-0242 and 0579-0446)


    Done in Washington, DC, this 2nd day of April 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-07073 Filed 4-5-18; 8:45 am]
 BILLING CODE 3410-34-P