[Federal Register Volume 83, Number 77 (Friday, April 20, 2018)]
[Proposed Rules]
[Pages 17503-17506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08251]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2016-0009]
RIN 0579-AE32


Importation of Fresh Cape Gooseberry Fruit From Ecuador to the 
Continental United States

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the fruits and vegetables 
regulations to allow the importation of fresh cape gooseberry fruit 
from Ecuador into the continental United States. As a condition of 
entry, fresh cape gooseberry fruit from Ecuador would be subject to a 
systems approach that would include requirements for establishment of 
pest-free places of production and the labeling of boxes prior to 
shipping. Fresh cape gooseberry fruit from non pest-free places of 
production would have to undergo approved cold treatment or 
irradiation. The fresh cape gooseberry fruit would also have to be 
imported in commercial consignments and accompanied by a phytosanitary 
certificate issued by the national plant protection organization of 
Ecuador certifying that the fruit has been produced in accordance with 
the systems approach. Fresh cape gooseberry fruit that does not meet 
the conditions of the systems approach would be allowed to be imported 
into the continental United States subject to treatment. This action 
would allow for the importation of fresh cape gooseberry fruit from 
Ecuador into the continental United States while continuing to provide 
protection against the introduction of plant pests.

DATES: We will consider all comments that we receive on or before June 
19, 2018.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2016-0009.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2016-0009, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2016-
0009 or in our reading room, which is located in Room 1141 of the USDA 
South Building, 14th Street and Independence Avenue SW, Washington, DC. 
Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through 
Friday, except holidays. To be sure someone is there to help you, 
please call (202) 799-7039 before coming.

FOR FURTHER INFORMATION CONTACT: Ms. Claudia Ferguson, Senior 
Regulatory Policy Specialist, Regulatory Coordination and Compliance, 
PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236; (301) 
851-2352.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in ``Subpart--Fruits and Vegetables'' (7 CFR 
319.56-1 through 319.56-82, 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 or dissemination of plant pests within the United States.
    The Animal and Plant Health Inspection Service (APHIS) received a 
request from the national plant protection organization (NPPO) of 
Ecuador to amend the regulations to allow the importation of 
commercially produced fresh cape gooseberry fruit (Physalis peruviana) 
from Ecuador into the continental United States. In evaluating 
Ecuador's request, we prepared a pest risk assessment (PRA) and a risk 
management document (RMD). Copies of the PRA and the RMD may be 
obtained from the person listed under FOR FURTHER INFORMATION CONTACT 
or viewed on the Regulations.gov website (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The PRA, titled ``Importation of Fresh Cape Gooseberry Fruit 
(Physalis peruviana L.) into the Continental United States from 
Ecuador'' (October 2011), analyzes the potential pest risk associated 
with the importation of fresh cape gooseberries into the continental 
United States from Ecuador.
    The PRA identifies Ceratitis capitata (Medfly) as the one 
quarantine pest that could be introduced into the United States in 
consignments of fresh cape gooseberry fruit from Ecuador. A quarantine 
pest is defined in Sec.  319.56-2 as ``a pest of potential economic 
importance to the area endangered by it and not yet present there, or 
present but not widely distributed there and being officially 
controlled.'' In the PRA, the likelihood and consequences of 
introducing this pest to the United States are considered, and Medfly 
is rated as having a high pest risk potential. Pests receiving a rating 
within this range may necessitate specific phytosanitary measures in 
addition to standard port-of-entry inspection of the commodity being 
imported into the continental United States.
    Based on the findings of the PRA, APHIS has determined that 
measures beyond standard port-of-entry inspection would mitigate the 
risks posed by this pest. These measures are listed in the RMD and are 
used as the basis for the requirements included in this proposed rule. 
We are therefore proposing to allow the importation of fresh cape 
gooseberry fruit from Ecuador into the continental United States if it 
is produced under a systems approach or subject to cold treatment or 
irradiation in accordance with the Plant Protection and Quarantine 
(PPQ) Treatment Manual \1\ and 7 CFR part 305. If shipments are treated 
with irradiation in Ecuador, they would have to be accompanied by 
documentation to validate foreign site preclearance

[[Page 17504]]

inspection of shipments of fresh cape gooseberry fruit after the 
required treatment is completed.
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    \1\ The PPQ Treatment Manual may be found on the internet at 
https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf.
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    All fruit, regardless of whether it was produced under the systems 
approach or subject to treatment would have to be imported in 
commercial consignments only and subject to the requirements regarding 
registered production areas and phytosanitary certification detailed 
below.
    These requirements would be added to the regulations as a new Sec.  
319.56-83.

Operational Workplan

    We would require the NPPO of Ecuador to provide an operational 
workplan to APHIS that details the activities the NPPO will carry out 
to meet the requirements of this regulation, subject to APHIS' approval 
of the workplan. APHIS would be directly involved with the NPPO in 
monitoring and auditing implementation of the systems approach. An 
operational workplan is an agreement between APHIS officials of the 
NPPO of a foreign government, and, when necessary, foreign commercial 
entities that specifies in detail the phytosanitary measures that will 
be carried out to comply with our regulations regarding a specific 
commodity. Operational workplans apply only to the signatory parties 
and establish detailed procedures and guidance for the day-to-day 
operations of specific import/export programs. Operational workplans 
also establish how specific phytosanitary issues are dealt with in the 
exporting country and make clear who is responsible for dealing with 
those issues. The implementation of a systems approach typically 
requires an operational workplan to be developed.

Commercial Consignments

    Only commercial consignments of fresh cape gooseberry fruit from 
Ecuador would be allowed to be imported into the continental United 
States. Produce grown commercially is less likely to be infested with 
plant pests than noncommercial consignments. Noncommercial consignments 
are more prone to infestations because the commodity is often ripe to 
overripe, could be of a variety with unknown susceptibility to pests, 
and is often grown with little or no pest control. Commercial 
consignments, as defined in Sec.  319.56-2, are consignments that an 
inspector identifies as having been imported for sale and distribution. 
Such identification is based on a variety of indicators, including, but 
not limited to: Quantity of produce, type of packaging, identification 
of grower or packinghouse on the packaging, and documents consigning 
the fruits or vegetables to a wholesaler or retailer.

Production Site Registration

    Under this proposed rule, the production site where the fruit is 
grown would be required to be registered with the NPPO of Ecuador. 
Official identification of the production site would have to be marked 
on all field cartons and containers of harvested fresh cape gooseberry 
fruit. Registration of production sites with the NPPO of Ecuador and 
marking of field cartons and containers with identification that would 
need to be maintained until the fruit is released for entry into the 
continental United States would allow traceback to the production site 
if pest problems were found on fruit shipped to the United States. 
Problem production sites could then be suspended until further 
mitigation measures were taken to address the pest populations.

Packinghouse Requirements

    All openings to the outside of the packinghouse must be covered by 
screening or by some other barrier that prevents pests from entering. 
The packinghouse must have double doors at the entrance to the facility 
and at the interior entrance to the area where the fresh cape 
gooseberry fruit is packed.

Phytosanitary Certificate

    Each consignment of fruit would have to be accompanied by a 
phytosanitary certificate issued by the NPPO of Ecuador that contains 
an additional declaration stating that the fruit in the consignment was 
produced in accordance with the requirements of Sec.  319.56-83.
    Requiring a phytosanitary certificate would ensure that the NPPO of 
Ecuador has certified that the fruit meets the conditions in the 
section for export to the United States.

Mitigation Measures for Medfly

    As stated previously the risks presented by Medfly would be 
addressed either via compliance with an established systems approach or 
treatment in accordance with the PPQ Treatment Manual and 7 CFR part 
305.

Systems Approach

    All places of production would have to be located within an area of 
low prevalence for Medfly. APHIS has reviewed and approved the methods 
used by the NPPO of Ecuador to survey for low pest prevalence and to 
recognize specific places of production as free of Medfly in the 
specified areas. Pest-free places of production within certified low 
pest prevalence areas have been effectively used in the past as an 
element of a systems approach to allow fruits to be safely imported 
into the United States, and we believe this measure can be successfully 
applied to the importation of fresh cape gooseberry fruit from Ecuador.
    We would require the use of trapping to monitor the places of 
production within low prevalence areas as part of the systems approach 
to mitigate the risk posed by Medfly. The NPPO of Ecuador would be 
required to certify that places of production have effective fruit fly 
trapping programs and follow pest control guidelines. The NPPO of 
Ecuador or its approved designee \2\ would be required to place fruit 
fly traps at intervals specified in the operational workplan to 
demonstrate place of production freedom from Medfly. Medfly capture 
would result in immediate cancellation of exports from farms within a 5 
kilometer radius of the detection site. An additional 50 traps would 
have to be placed in the 5 square kilometers area surrounding the 
detection site. If a second detection is made within the detection area 
within 30 days of the first, eradication using a bait spray agreed upon 
by APHIS and the NPPO of Ecuador would have to be initiated in the 
detection area and treatment would have to continue for at least 2 
months. Exports could resume from the detection area when APHIS and the 
NPPO of Ecuador agree the risk has been mitigated. These requirements 
would ensure that production sites are monitored, that no fruit is 
shipped from sites where Medfly has been detected, and that the 
presence of Medfly is addressed quickly and definitively. Affected 
sites would still be eligible to export fruit to the United States 
subject to treatment as described below.
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    \2\ 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. The approved designee 
can be a contracted entity, a coalition of growers, or the growers 
themselves.
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    After the commodity is packed, the NPPO of Ecuador must visually 
inspect the fresh cape gooseberry fruit at a rate jointly approved by 
APHIS and the NPPO of Ecuador. Any fruit displaying evidence of pest 
presence must be cut open for further examination. External and 
internal inspection of a sample would ensure that pests at various life 
stages are detected. Any consignment that does not pass inspection may 
still be imported into the continental United States subject to 
treatment as described below.

[[Page 17505]]

Treatments

    Fresh cape gooseberry fruit that comes from a place of production 
that does not qualify as a pest free place of production in an area of 
low pest prevalence may still be exported to the continental United 
States subject to cold treatment or irradiation treatment in accordance 
with the PPQ Treatment Manual and 7 CFR part 305.

Executive Orders 12866 and 13771 and Regulatory Flexibility Act

    This proposed 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 is not subject to the requirements of 
Executive Order 13771. However, the Department considers this a 
deregulatory action for purposes of Executive Order 13771.
    We have prepared an economic analysis for this rule. The economic 
analysis provides a cost-benefit analysis, as required by Executive 
Orders 12866, which direct agencies to assess all costs and benefits of 
available regulatory alternatives and, if regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety effects, 
and equity). The economic analysis also examines the potential economic 
effects of this rule on small entities, as required by the Regulatory 
Flexibility Act. The economic analysis is summarized below. Copies of 
the full analysis are available by contacting the person listed under 
FOR FURTHER INFORMATION CONTACT or on the Regulations.gov website (see 
ADDRESSES above for instructions for accessing Regulations.gov). APHIS 
is proposing to amend the current regulations to allow the entry of 
fresh cape gooseberry fruit from Ecuador into the continental United 
States under approved treatment protocols or a systems approach. The 
proposal would benefit U.S. fresh fruit importers and merchants by 
providing for an additional source for fresh cape gooseberry fruit. 
U.S. import levels for fresh cape gooseberry fruit are not known 
because fresh cape gooseberry fruit is aggregated in U.S. census trade 
statistics with black, white, and red currants under the Harmonized 
Trade Schedule 081030. In 2015, the United States imported 
approximately 78.7 metric tons of gooseberries and currants valued at 
about $476,000. Data are not readily available pertaining to Ecuador's 
production and export of fresh cape gooseberry fruit, nor is the 
quantity of fresh cape gooseberry fruit expected to be imported into 
the United States from Ecuador known.
    The United States does not produce fresh cape gooseberry fruit 
commercially. Small entities that would benefit from fresh cape 
gooseberry fruit imports from Ecuador would be importers, wholesalers, 
and other merchants who sell this fruit. While these industries are 
primarily comprised of small entities, APHIS expects any impacts of the 
rule for these businesses to be minor.
    Under these circumstances, the Administrator of the Animal and 
Plant Health Inspection Service has determined that this action would 
not have a significant economic impact on a substantial number of small 
entities.

Executive Order 12988

    This proposed rule would allow fresh cape gooseberry fruit to be 
imported into the continental United States from Ecuador. If this 
proposed rule is adopted, State and local laws and regulations 
regarding fresh cape gooseberry fruit imported under this rule would be 
preempted while the fruit is in foreign commerce. Fresh fruit is 
generally imported for immediate distribution and sale to the consuming 
public and would 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. If this proposed rule is 
adopted, 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.), reporting and recordkeeping 
requirements included in this proposed rule have been submitted for 
approval to the Office of Management and Budget (OMB). Please send 
comments on the Information Collection Request (ICR) to OMB's Office of 
Information and Regulatory Affairs via email to 
[email protected], Attention: Desk Officer for APHIS, 
Washington, DC 20503. Please state that your comments refer to Docket 
No. APHIS-2016-0009. Please send a copy of your comments to the USDA 
using one of the methods described under ADDRESSES at the beginning of 
this document.
    APHIS is proposing to allow the importation of fresh cape 
gooseberry fruit from Ecuador into the continental United States under 
certain conditions designed to prevent the introduction of Ceratitis 
capitata. Implementing this rule will require information collection 
activities such as an operational workplan prepared by the NPPO of 
Ecuador, production site registration, the marking of fruit cartons 
with identification of their production sites, phytosanitary 
inspections and certificates, preparing a certified low prevalence area 
production site list, notices of suspension to export and notices of 
resumption to export, preclearance inspection documentation, import 
permit applications, port notices of arrival, port emergency action 
notifications, and creation and maintenance of pest monitoring, 
trapping, and production records.
    We are soliciting comments from the public (as well as affected 
agencies) concerning our proposed information collection and 
recordkeeping requirements. These comments will help us:
    (1) Evaluate whether the proposed information collection is 
necessary for the proper performance of our agency's functions, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of our estimate of the burden of the 
proposed information collection, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the information collection on those who 
are to respond (such as through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology; e.g., permitting electronic 
submission of responses).
    Estimate of burden: Public reporting burden for this collection of 
information is estimated to average 0.036 hours per response.
    Respondents: NPPO of Ecuador, production site and packing site 
managers, and importers of cape gooseberry from Ecuador.
    Estimated annual number of respondents: 147.
    Estimated annual number of responses per respondent: 1,441.
    Estimated annual number of responses: 211,882.
    Estimated total annual burden on respondents: 7,566 hours. (Due to 
averaging, the total annual burden hours may not equal the product of 
the annual number of responses multiplied by the reporting burden per 
response.)
    A copy of the information collection may be viewed on the 
Regulations.gov website or in our reading room. (A link to 
Regulations.gov and information on

[[Page 17506]]

the location and hours of the reading room are provided under the 
heading ADDRESSES at the beginning of this proposed rule.) Copies can 
also be obtained from Ms. Kimberly Hardy, APHIS' Information Collection 
Coordinator, at (301) 851-2483. APHIS will respond to any ICR-related 
comments in the final rule. All comments will also become a matter of 
public record.

E-Government Act Compliance

    The Animal and Plant Health Inspection Service is committed to 
compliance with the EGovernment 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 proposed 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 propose to amend 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. Add Sec.  319.56-83 to read as follows:


Sec.  319.56-83  Fresh cape gooseberry from Ecuador.

    Fresh cape gooseberry (Physalis peruviana) fruit 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 Ceratitis capitata.
    (a) General requirements. (1) The national plant protection 
organization (NPPO) of Ecuador must provide an operational workplan to 
APHIS that details the activities that the NPPO of Ecuador will, 
subject to APHIS' approval of the workplan, carry out to meet the 
requirements of this section. APHIS will be directly involved with the 
NPPO of Ecuador in monitoring and auditing implementation of the 
systems approach.
    (2) The production site where the fruit is grown must be registered 
with the NPPO of Ecuador.
    (3) Harvested fresh cape gooseberry fruit must be placed in field 
cartons or containers that are marked to show the official 
identification of the production site.
    (4) All openings to the outside of the packinghouse where the fruit 
is packed must be covered by screening or by some other barrier that 
prevents pests from entering. The packinghouse must have double doors 
at the entrance to the facility and at the interior entrance to the 
area where the fresh cape gooseberry fruit is packed.
    (5) Each consignment of fresh cape gooseberry fruit must be 
accompanied by a phytosanitary certificate issued by the NPPO of 
Ecuador that contains an additional declaration stating that the fruit 
in the consignment was produced in accordance with Sec.  319.56-83.
    (b) Commercial consignments. The fresh cape gooseberry fruit may be 
imported in commercial consignments only.
    (c) To be eligible for importation, the fresh cape gooseberry fruit 
must either be produced and shipped under the systems approach 
described in paragraph (d) of this section or treated in accordance 
with paragraph (e) of this section.
    (d) Systems approach. The fresh cape gooseberry fruit may be 
imported without treatment if it is subject to a systems approach 
consisting of the following:
    (1) Low-prevalence production site certification. The fruit must 
originate from a registered production site within a low prevalence 
area for C. capitata that has been certified as such by the NPPO of 
Ecuador.
    (2) Fruit fly trapping. (i) Trapping for C. capitata must be 
conducted in the places of production in accordance with the 
operational workplan to demonstrate that those places are free of C. 
capitata. Specific trapping requirements must be included in the 
operational workplan. The NPPO of Ecuador must keep records of fruit 
fly detections for each trap and make the records available to APHIS 
upon request.
    (ii) All fruit flies trapped must be reported to APHIS immediately. 
Capture of C. capitata will result in immediate cancellation of exports 
from farms within 5 kilometer radius of the detection site. An 
additional 50 traps must be placed in the 5 square kilometer area 
surrounding the detection site. If a second detection is made within 
the detection areas within 30 days of a previous capture, eradication 
using a bait spray agreed upon by APHIS and the NPPO of Ecuador must be 
initiated in the detection area. Treatment must continue for at least 2 
months. Sites whose exports have been canceled under this paragraph 
will be eligible to export fruit to the United States only if the fruit 
is treated in accordance with paragraph (e) of this section. Exports 
may resume from the detection area in accordance with this paragraph 
(d) when APHIS and the NPPO of Ecuador agree the risk has been 
mitigated.
    (3) Phytosanitary inspection. After packing, the NPPO of Ecuador 
must visually inspect the fresh cape gooseberry fruit at a rate jointly 
approved by APHIS and the NPPO of Ecuador. Any fruit displaying 
evidence of pest presence must be cut open for further examination. 
Only in the case where at least one single live C. capitata is found, 
the consignment will not pass inspection. Any consignment that does not 
pass inspection may still be imported into the continental United 
States subject to treatment as provided in paragraph (e) of this 
section.
    (e) Treatment. The fresh cape gooseberry fruit may be imported into 
the continental United States without meeting the conditions of 
paragraph (d) of this section if the fruit is subject to cold treatment 
or irradiation treatment in accordance with part 305 of this chapter. 
If the irradiation treatment is completed in Ecuador, each consignment 
of fresh cape gooseberry fruit must be accompanied by documentation to 
validate foreign site preclearance inspection of the consignment.

    Done in Washington, DC, this 16th day of April 2018.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2018-08251 Filed 4-19-18; 8:45 am]
 BILLING CODE 3410-34-P