[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Rules and Regulations]
[Pages 27967-27970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12802]



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 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
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 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.
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 The Code of Federal Regulations is sold by the Superintendent of Documents. 
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  Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Rules 
and Regulations  

[[Page 27967]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2015-0004]
RIN 0579-AE12


Importation of Fresh Pitahaya Fruit From Ecuador Into the 
Continental United States

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 fresh pitahaya fruit into the continental United 
States from Ecuador. As a condition of entry, the fruit will have to be 
produced in accordance with a systems approach that includes 
requirements for fruit fly trapping, pre-harvest inspections, approved 
production sites, and packinghouse procedures designed to exclude 
quarantine pests. The fruit will also be required to be imported in 
commercial consignments and accompanied by a phytosanitary certificate 
issued by the national plant protection organization of Ecuador stating 
that the consignment was produced and prepared for export in accordance 
with the requirements of the systems approach. This action will allow 
for the importation of fresh pitahaya fruit from Ecuador while 
continuing to provide protection against the introduction of plant 
pests into the United States.

DATES: Effective July 20, 2017.

FOR FURTHER INFORMATION CONTACT: Ms. Claudia Ferguson, M.S., Senior 
Regulatory Policy Specialist, Regulatory Coordination and Compliance, 
Imports, Regulations and Manuals, PPQ, APHIS, 4700 River Road Unit 133, 
Riverdale, MD 20737-1231; (301) 851-2352; email: 
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    Under the regulations in ``Subpart--Fruits and Vegetables'' (7 CFR 
319.56-1 through 319.56-76, referred to below as the regulations), the 
Animal and Plant Health Inspection Service (APHIS) of the U.S. 
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.
    On April 8, 2016, we published in the Federal Register (81 FR 
20575-20579, Docket No. APHIS-2015-0004) a proposal \1\ to amend the 
regulations in order to allow fresh fruit of any color of pitahaya 
(Hylocereus spp., Acanthocereus spp., Cereus spp., Echinocereus spp., 
Escontria spp., Myrtillocactus spp., and Stenocereus spp.) to be 
imported into the continental United States. (Hereafter we refer to 
these species collectively as ``pitahaya.'') We also prepared a pest 
risk assessment (PRA) and a risk management document (RMD). The PRA 
evaluates the risks associated with the importation of fresh pitahaya 
fruit from Ecuador into the continental United States. The RMD relies 
upon the findings of the PRA to determine the phytosanitary measures 
necessary to ensure the safe importation into the continental United 
States of fresh pitahaya fruit from Ecuador.
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    \1\ To view the proposed rule, public comments, and supporting 
documents, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2015-0004.
---------------------------------------------------------------------------

    In the proposed rule, we noted that the PRA identified one 
quarantine pest present in Ecuador that could be introduced into the 
continental United States through the importation of fresh pitahaya 
fruit: Anastrepha fraterculus (Wiedemann), South American fruit fly.
    We determined in the PRA that measures beyond standard port of 
arrival inspection will mitigate the risks posed by this plant pest and 
proposed a systems approach that includes requirements for fruit fly 
trapping, pre-harvest inspections, approved production sites, and 
packinghouse procedures designed to exclude quarantine pests. The fresh 
pitahaya fruit will also be required to be imported in commercial 
consignments and accompanied by a phytosanitary certificate issued by 
the national plant protection organization (NPPO) of Ecuador stating 
that the consignment was produced and prepared for export in accordance 
with the requirements of the systems approach.
    We solicited comments concerning our proposal for 60 days ending 
June 7, 2016. We received 12 comments during the comment period.
    Eight commenters, consisting of shippers, growers, and consumers, 
stated general support for the proposed action. The remaining four 
commenters did not categorically oppose the rule but did raise 
questions about its provisions that we address below.
    One commenter stated that the proposed rule indicates there is a 
lack of adequate data that would allow APHIS to determine the economic 
effects of the rule. The commenter added that additional analysis 
should be conducted to ensure that small entities, specifically the 
United States pitahaya growers, should not receive any adverse effects 
of this rule change.
    We note in the final regulatory flexibility analysis prepared for 
this rule that we received no adverse comments with respect to the 
specific economic impacts on small entities. Therefore, in the absence 
of apparent significant economic impacts and based on our review of 
available information, APHIS does not expect the proposed rule to have 
a significant economic impact on small entities and that additional 
analysis is not necessary.
    The same commenter asked why the operational workplan required in 
proposed Sec.  319.56-77(a) \2\ does not outline any specific 
requirements for the workplan itself, other than that it must be 
approved by APHIS.
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    \2\ In the proposed rule, the section number we proposed to 
include in the Code of Federal Regulations was Sec.  319.56-76. As 
another rulemaking was published between the proposed and final 
versions of this rule, we have adjusted the number for this 
rulemaking accordingly.
---------------------------------------------------------------------------

    Section 319.56-77(a) does in fact outline specific requirements 
that must be met by the operational workplan. The workplan provided to 
APHIS by the NPPO of Ecuador must detail activities that the NPPO of 
Ecuador will, subject to APHIS' approval of the workplan, carry out to 
meet the requirements of the section.
    Four commenters communicated concerns about the risk of introducing

[[Page 27968]]

A. fraterculus into the continental United States via the pathway of 
fresh pitahaya imported from Ecuador.
    One commenter representing the State of Florida stated that an 
introduction of A. fraterculus would severely impact Florida's $8.25 
billion dollar agricultural industry. The commenter stated that fruit 
infested with internal A. fraterculus larvae are highly likely to 
escape detection during culling and recommended that shipments of 
pitahaya from Ecuador not be allowed into Florida. Another commenter 
representing an organization of State plant regulatory agencies was not 
opposed to the proposed systems approach as long as there is full 
adoption of the control measures identified in the RMD to manage A. 
fraterculus and strict monitoring and enforcement of the systems 
approach. The commenter noted Florida's recommendation to prohibit 
shipments of pitahaya from Ecuador into Florida but did not state a 
position on the recommendation.
    We acknowledge the commenters' concerns over the risk of 
introducing A. fraterculus into the continental United States via the 
pathway of fresh pitahaya from Ecuador, particularly in areas of the 
southern United States that could sustain permanent A. fraterculus 
populations. However, we have determined that the production and 
inspection practices contained in the systems approach, which include 
requirements for fruit fly trapping, pre-harvest inspections, and 
packinghouse pest exclusion procedures, will sufficiently mitigate the 
risk of A. fraterculus in imports of fresh pitahayas from Ecuador.
    Moreover, during a 2016 site visit to Ecuador conducted after 
publication of the proposed rule, we determined the host population of 
A. fraterculus in pitahaya areas of production to be negligible with 
respect to pest risk, rendering unnecessary the proposed requirement 
prohibiting other host crops of A. fraterculus to be grown within 100 
meters of pitahaya fields. Therefore, we are removing the requirement 
by amending proposed Sec.  319.56-77(c)(2) accordingly.
    One commenter noted that proposed Sec.  319.56-77(e)(2) states the 
action that must be taken if a single larva of A. fraterculus is found 
in a shipment. The commenter asked if more than a single larva is 
found, whether further action will be taken regarding the remaining 
shipment of pitahaya fruit on lots other than that in which the larva 
was discovered.
    The requirement in Sec.  319.56-77(e)(2) states that if a single 
larva of A. fraterculus is found in a shipment from a place of 
production (either by the NPPO in Ecuador or by inspectors at the 
continental United States port of entry), the entire lot of fruit will 
be prohibited from import into the United States and the place of 
production of that fruit will be suspended from the export program 
until appropriate measures agreed upon by the NPPO of Ecuador and APHIS 
have been taken. In other words, all lots comprising that shipment will 
be prohibited from import into the United States regardless of whether 
one or more larvae of A. fraterculus are found. Furthermore, suspension 
of the place of production from the export program will allow the NPPO 
and APHIS to take appropriate measures to mitigate the risk of future 
detections in shipments of pitahayas from that place of production.
    Another commenter, concerned by the risk posed by A. fraterculus, 
stated that APHIS is over-relying on the NPPO of Ecuador to enforce 
pest control protocols and that measures should be adopted for 
additional review of the NPPO's enforcement actions.
    We consider APHIS' oversight of the NPPO of Ecuador's enforcement 
of the systems approach to be adequate to mitigate the risk of A. 
fraterculus following the pathway of fresh pitahaya from Ecuador to the 
continental United States. Under Sec.  319.56-77(a), the NPPO of 
Ecuador must provide an operational workplan to APHIS that details 
activities that the NPPO of Ecuador will, subject to APHIS' approval of 
the workplan, carry out to meet the requirements of this section. In 
addition, each consignment of pitahaya fruit must be accompanied by a 
phytosanitary certificate issued by the NPPO of Ecuador stating that 
the consignment was produced and prepared for export in accordance with 
the requirements of the systems approach in Sec.  319.56-77. 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 rule is 
not significant, it does not trigger the requirements of Executive 
Order 13771.
    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 rule amends the regulations to allow the importation of fresh 
pitahaya fruit (of any color) (Hylocereus spp., Acanthocereus spp., 
Cereus spp., Echinocereus spp., Escontria spp., Myrtillocactus spp., 
and Stenocereus spp.) into the continental United States from Ecuador 
using a systems approach to pest risk mitigation. The systems approach 
will integrate prescribed mitigation measures that cumulatively achieve 
the appropriate level of phytosanitary protection. Entities potentially 
affected by the rule are U.S. pitahaya fruit growers, of which most, if 
not all, are small entities.
    Pitahaya fruit, or dragon fruit, is produced in Hawaii, California, 
and Florida. It is estimated that these States produce over 11,000 
metric tons of pitahaya fruit per year. The quantity of pitahaya fruit 
that will be imported from Ecuador is uncertain, but the entire 
pitahaya export volume of Ecuador is estimated to be 165 metric tons, 
which is 1.4 percent of U.S. production.
    Farms producing pitahaya fruit are classified within the North 
American Industry Classification System under Other Noncitrus Fruit 
Farming (NAICS 111339). For this industry classification, a business is 
considered to be a small entity if its annual receipts are not more 
than $750,000. It is probable that most or all U.S. producers of 
pitahaya are small businesses by the U.S. Small Business Administration 
standard. We expect any impact of the rule for these entities will be 
minimal, given Ecuador's expected small share of the U.S. pitahaya 
market.
    Based on our review of available information, APHIS does not expect 
the rule to have a significant economic impact on small entities. In 
the absence of significant economic impacts, we have not identified 
alternatives that will minimize such impacts.

Executive Order 12988

    This final rule allows fresh pitahaya fruit to be imported into the 
continental United States from Ecuador. State and local laws and 
regulations regarding fresh pitahaya 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

[[Page 27969]]

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 0579-0447, 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.

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


0
2. Section 319.56-77 is added to read as follows:


Sec.  319.56-77  Pitahaya from Ecuador.

    Fresh pitahaya (Hylocereus spp., Acanthocereus spp., Cereus spp., 
Echinocereus spp., Escontria spp., Myrtillocactus spp., and Stenocereus 
spp.) from Ecuador may be imported into the continental United States 
only under the conditions described in this section. These conditions 
are designed to prevent the introduction of the following quarantine 
pest: Anastrepha fraterculus (Wiedemann), South American fruit fly.
    (a) General requirements. The national plant protection 
organization (NPPO) of Ecuador must provide an operational workplan to 
APHIS that details activities that the NPPO of Ecuador 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.
    (b) Commercial consignments. Pitahaya from Ecuador may be imported 
in commercial consignments only.
    (c) Production site requirements. (1) All production sites that 
participate in the pitahaya export program must be approved by and 
registered with the NPPO of Ecuador in accordance with the operational 
workplan.
    (2) Trees and other structures, other than the crop itself, must 
not shade the crop during the day. Pitahaya fruit that has fallen on 
the ground must be removed from the place of production at least once 
every 7 days and may not be included in field containers of fruit to be 
packed for export. Harvested pitahayas must be placed in field cartons 
or containers that are marked to show the place of production so that 
traceback is possible.
    (3) The production sites must be inspected prior to each harvest by 
the NPPO of Ecuador or its approved designee in accordance with the 
operational workplan. An approved designee is an entity with which the 
NPPO creates a formal agreement that allows that entity to certify that 
the appropriate procedures have been followed. If APHIS or the NPPO of 
Ecuador finds that a place of production is not complying with the 
requirements of the systems approach, no fruit from the place of 
production will be eligible for export to the continental United States 
until APHIS and the NPPO of Ecuador conduct an investigation and 
appropriate remedial actions have been implemented.
    (4) The registered production sites must conduct trapping for the 
fruit fly A. fraterculus at each production site in accordance with the 
operational workplan. Personnel conducting the trapping and pest 
surveys must be hired, trained, and supervised by the NPPO of Ecuador. 
The trapping must begin at least 1 year before harvest begins and 
continue through the completion of harvest.
    (5) If more than an average of 0.07 A. fraterculus per trap per day 
is trapped for more than 2 consecutive weeks, the production site will 
be ineligible for export until the rate of capture drops to less than 
that average. If levels exceed that average per trap per day, from 2 
months prior to harvest to the end of the shipping season, the 
production site will be prohibited from shipping under the systems 
approach until APHIS and the NPPO of Ecuador both agree that the pest 
risk has been mitigated. As conditions warrant, the average number of 
A. fraterculus per trap per day may be raised or lowered if jointly 
agreed to between APHIS and the NPPO of Ecuador in the operational 
workplan.
    (6) The NPPO of Ecuador must maintain records of trap placement, 
checking of traps, and any quarantine pest captures in accordance with 
the operational workplan. Trapping records must be maintained for APHIS 
review for at least 1 year.
    (d) Packinghouse requirements. (1) The NPPO of Ecuador must monitor 
packinghouse operations to verify that the packinghouses are complying 
with the requirements of the systems approach. If the NPPO of Ecuador 
finds that a packinghouse is not complying with the requirements of the 
systems approach, no pitahaya fruit from the packinghouse will be 
eligible for export to the continental United States until APHIS and 
the NPPO of Ecuador conduct an investigation and both agree that the 
pest risk has been mitigated.
    (2) All packinghouses that participate in the pitahaya export 
program must be registered with the NPPO of Ecuador.
    (3) The pitahaya fruit must be packed within 24 hours of harvest in 
a pest-exclusionary packinghouse. The pitahaya shipment must be 
safeguarded by an insect-proof mesh screen or plastic tarpaulin while 
in transit to the packinghouse and while awaiting packing. These 
safeguards must remain intact until arrival in the continental United 
States or the consignment will be denied entry.
    (4) During the time the packinghouse is in use for exporting 
pitahaya fruit to the continental United States, the packinghouse may 
only accept pitahaya fruit from registered production sites.
    (e) Phytosanitary inspection. (1) A biometric sample of pitahaya 
fruit (jointly agreed upon by APHIS and the NPPO) must be inspected in 
Ecuador by the NPPO of Ecuador following post-harvest processing. The 
biometric sample must be visually inspected for any quarantine pests, 
and a portion of the fruit will be cut open if signs of A. fraterculus 
are observed.
    (2) Pitahaya fruit presented for inspection at the port of entry to 
the United States must be identified in the shipping documents 
accompanying each lot of fruit to specify the production site or sites, 
in which the fruit was produced, and the packinghouse or houses in 
which the

[[Page 27970]]

fruit was processed, in accordance with the requirements in the 
operational workplan. This identification must be maintained until the 
fruit is released for entry into the continental United States. The 
pitahaya fruit are subject to inspection at the port of entry for all 
quarantine pests of concern, including A. fraterculus. If a single 
larva of A. fraterculus is found in a shipment from a place of 
production (either by the NPPO in Ecuador or by inspectors at the 
continental United States port of entry), the entire lot of fruit will 
be prohibited from importation into the continental United States, and 
the place of production of that fruit will be suspended from the export 
program until appropriate measures agreed upon by the NPPO of Ecuador 
and APHIS have been taken.
    (f) Phytosanitary certificate. Each consignment of pitahaya fruit 
must be accompanied by a phytosanitary certificate issued by the NPPO 
of Ecuador stating that the consignment was produced and prepared for 
export in accordance with the requirements of Sec.  319.56-77.

(Approved by the Office of Management and Budget under control 
number 0579-0447.)

    Done in Washington, DC, this 14th day of June 2017.
Michael C. Gregoire,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2017-12802 Filed 6-19-17; 8:45 am]
 BILLING CODE 3410-34-P