81_FR_19127 81 FR 19063 - Importation of Lemons From Chile Into the Continental United States

81 FR 19063 - Importation of Lemons From Chile Into the Continental United States

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 81, Issue 64 (April 4, 2016)

Page Range19063-19066
FR Document2016-07673

We are proposing to amend 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 would 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 would have to undergo pre-harvest sampling at the registered production site. Following post-harvest processing, the fruit would have to be inspected in Chile at an approved inspection site. Each consignment of fruit would have to be accompanied by a phytosanitary certificate with an additional declaration stating that the fruit had been found free of Brevipalpus chilensis based on field and packinghouse inspections. This proposed rule would allow for the safe importation of lemons from Chile using mitigation measures other than fumigation with methyl bromide.

Federal Register, Volume 81 Issue 64 (Monday, April 4, 2016)
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19063-19066]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-07673]


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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: Proposed rule.

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SUMMARY: We are proposing to amend 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 would 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 would have to undergo pre-harvest 
sampling at the registered production site. Following post-harvest 
processing, the fruit would have to be inspected in Chile at an 
approved inspection site. Each consignment of fruit would have to be 
accompanied by a phytosanitary certificate with an additional

[[Page 19064]]

declaration stating that the fruit had been found free of Brevipalpus 
chilensis based on field and packinghouse inspections. This proposed 
rule would allow for the safe importation of lemons from Chile using 
mitigation measures other than fumigation with methyl bromide.

DATES: We will consider all comments that we receive on or before June 
3, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0051.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0051, 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-2015-
0051 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: Mr. George Balady, Senior Regulatory 
Policy Specialist, Regulatory Coordination and Compliance, Plant Health 
Programs, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; 
(301) 851-2240.

SUPPLEMENTARY INFORMATION:

Background

    Under the regulations in ``Subpart-Fruits and Vegetables'' (7 CFR 
319.56-1 through 319.56-74, 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.
    The regulations in Sec.  319.56-4(a) provide that fruits and 
vegetables that can be imported using one or more of the designated 
phytosanitary measures in Sec.  319.56-4(b) to mitigate risk will be 
listed, along with the applicable requirements for their importation, 
on the Internet (currently in the Fruits and Vegetables Import 
Requirements [FAVIR] database at www.aphis.usda.gov/favir). Under those 
provisions, lemons from Chile (Citrus limon (L.) Burm. f.) are 
currently 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 applied in Chile under an APHIS preclearance program.
    The regulations in Sec.  319.56-4(a) also provide that commodities 
that require phytosanitary measures other than those measures cited 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. Under those provisions, other 
citrus fruits, including 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. The conditions 
applicable to the importation of citrus from Chile are listed in Sec.  
319.56-38.
    In this document, we are proposing to amend Sec.  319.56-38 to 
include 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.
    Our review of the information supporting the safe importation into 
the United States of citrus from Chile under the listed phytosanitary 
measures is examined in a commodity import evaluation document (CIED) 
titled ``Importation of Fresh Lemons (Citrus limon (L.) Burm. F.), from 
Chile into the Continental United States Using a Systems Approach.'' 
Copies of the CIED may be obtained from the person listed under FOR 
FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site 
or in our reading room (see ADDRESSES above for a link to 
Regulations.gov and information on the location and hours of the 
reading room).
    In June 2010, APHIS recognized all of Chile as a pest-free area 
with respect to Ceratitis capitata, the Mediterranean fruit fly. 
Therefore, the CIED identifies one quarantine pest that could be 
introduced into the United States in consignments of lemon from Chile: 
B. chilensis. A quarantine pest is defined in Sec.  319.56-2 as ``a 
pest of potential economic importance to the area endangered thereby 
and not yet present there, or present but not widely distributed and 
being officially controlled.'' In the CIED, the likelihood and 
consequences of introducing this pest to the United States are 
considered, and B. chilensis is rated as having a medium pest risk 
potential. Pests receiving a rating within the medium range may 
necessitate specific phytosanitary measures in addition to standard 
port-of-entry inspection of the commodity being imported into the 
United States.
    Based on the findings of our CIED, we are proposing to allow the 
importation of fresh lemons from Chile into the United States subject 
to the same systems approach in place for other citrus from Chile. 
Under a systems approach, a set of phytosanitary conditions, at least 
two of which have an independent effect in mitigating the pest risk 
associated with the movement of commodities, is specified, whereby 
fruits and vegetables may be imported into the United States from 
countries that are not free of certain plant pests. The systems 
approach for lemons from Chile would require the fruit to be grown in a 
place of production that is registered with the national plant 
protection organization (NPPO) of Chile. The fruit would have to 
undergo pre-harvest sampling at the registered production site under 
the direction of the NPPO of Chile. The NPPO of Chile would present a 
list of production sites certified as having a low prevalence of B. 
chilensis to APHIS. Following post-harvest processing, the fruit would 
have to be inspected in Chile at an APHIS-approved inspection site 
under the direction of APHIS inspectors in coordination with the NPPO 
of Chile. Each consignment of the fruit would have to be accompanied by 
a phytosanitary certificate with an additional declaration stating that 
the lemons in the consignment meet the conditions of the systems 
approach and are free of B. chilensis. The mitigation measures in the 
proposed systems approach are discussed in greater detail below.

Production Site Registration

    The production site where the lemons are grown would have to be 
registered with the NPPO of Chile. To register, the production site 
must provide the NPPO of Chile with the following information: 
Production site name, grower name, municipality, province, region, area 
planted to each species, number of plants/hectares/species, and 
approximate date of harvest. Registration would have to be renewed 
annually.
    Registration of production sites is required to manage production 
site requirements and to control access to

[[Page 19065]]

the program to only qualified sites. Commercially grown shipments from 
registered production sites use good agricultural practices to reduce 
or eliminate pests.

Low-Prevalence Production Site Certification

    Between 1 and 30 days prior to harvest, random samples of fruit 
would have to be collected from each registered production site under 
the direction of the NPPO of Chile. These samples would have to undergo 
a pest detection and evaluation method as follows: The fruit would have 
to be washed using a flushing method, placed in a 20-mesh sieve on top 
of a 200-mesh sieve, sprinkled with a liquid soap and water solution, 
washed with water at high pressure, and washed with water at low 
pressure. The washing process would then be repeated immediately after 
the first washing. The contents of the 200-mesh sieve would then be 
placed on a petri dish and analyzed for the presence of live B. 
chilensis mites. If a single live B. chilensis mite is found, the 
production site would not qualify for certification as a low-prevalence 
production site and would be eligible to export fruit to the United 
States only if the fruit is fumigated with methyl bromide either in 
Chile or at the port of first arrival in the United States. Each 
production site would have only one opportunity per season to qualify 
as a low-prevalence production site, and certification of low 
prevalence would be valid for one harvest season only. The NPPO of 
Chile would be required to present a list of certified production sites 
to APHIS annually.

Post-Harvest Processing

    After harvest and before packing, the fruit would have to be 
washed, rinsed in a potable water bath, washed with detergent with 
brushing using bristle rollers, rinsed with a hot water shower with 
brushing using bristle rollers, predried at room temperature, waxed, 
and dried with hot air. These mitigations aid in removing any pests 
from the fruit.

Phytosanitary Inspection

    The fruit would have to be inspected in Chile at an APHIS-approved 
inspection site under the direction of APHIS inspectors in coordination 
with the NPPO of Chile following any post-harvest processing. A 
biometric sample would be drawn from each consignment, which may 
represent multiple grower lots from different packing sheds. 
Consignments with mites will be rejected from the systems approach. 
Rejected lots may still be exported to the United States but would 
require fumigation with methyl bromide either in Chile or at the port 
of first arrival in the United States in accordance with Sec.  305.5 of 
the regulations.

Phytosanitary Certificate

    Each consignment of fruit would have to be accompanied by a 
phytosanitary certificate issued by the NPPO of Chile that contains an 
additional declaration stating that the lemons in the consignment meet 
the conditions of the systems approach and are free of B. chilensis. 
Requiring a phytosanitary certificate ensures that the NPPO of Chile 
inspects the lemons for pests.

Executive Order 12866 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.
    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 
by contacting the person listed under FOR FURTHER INFORMATION CONTACT 
or on the Regulations.gov Web site (see ADDRESSES above for 
instructions for accessing Regulations.gov).
    The Government of Chile submitted a market access request for lemon 
fruit to be approved for import into the continental United States 
using a systems approach as an alternative to methyl bromide 
fumigation, to mitigate the risk of introduction of the Chilean false 
red mite.
    The United States is a net exporter of fresh lemon; over 5 seasons 
(2009/10-2013/14), annual exports averaged about 102,410 metric tons 
(MT) (19 percent of production), compared to annual imports that 
averaged about 46,270 MT. Based on the Small Business Administration 
small-entity standards, the majority of entities that comprise 
industries that may be affected by this rule are small. These entities 
include lemon producers, packers, wholesalers, retailers, and 
importers.
    Chile supplies about one-third of U.S. fresh lemon imports. Chile's 
Ministry of Agriculture estimates that approximately 60 percent of 
their lemon consignments to the United States will switch from methyl 
bromide treatment to the systems approach. Chile currently exports 
about 15,000 MT per year to the United States, of which the systems 
approach is expected to be used for 8,500 to 9,000 MT. For this reason, 
the proposed rule is not expected to result in a significant increase 
in Chilean lemon exports to the United States or their competitiveness.
    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 lemon fruit to be imported into the 
continental United States from Chile. If this proposed rule is adopted, 
State and local laws and regulations regarding lemon fruit imported 
under this rule would be preempted while the fruit is in foreign 
commerce. Fresh fruits are 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.), the information collection or 
recordkeeping requirements included in this proposed rule have been 
submitted for approval to the Office of Management and Budget (OMB). 
Please send written comments to the Office of Information and 
Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, 
DC 20503. Please state that your comments refer to Docket No. APHIS-
2015-0051. Please send a copy of your comments to: (1) APHIS, using one 
of the methods described under ADDRESSES at the beginning of this 
document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th 
Street and Independence Avenue SW., Washington, DC 20250.
    APHIS is proposing to amend 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 would 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 B. chilensis. The 
fruit would have to undergo pre-harvest sampling at the registered 
production site. Following post-harvest processing, the fruit would 
have to be inspected in Chile at an

[[Page 19066]]

approved inspection site. Each consignment of fruit would 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 proposed rule would 
allow for the safe importation of lemons from Chile using mitigation 
measures other than fumigation with methyl bromide.
    Implementing this rule will require permits, production site 
registration with low-prevalence level certification option, 
phytosanitary inspections, phytosanitary certificates, and chemical 
treatment procedures.
    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 0.6917 hours per response.
    Respondents: Producers and importers of lemons, and the NPPO of 
Chile.
    Estimated annual number of respondents: 198.
    Estimated annual number of responses per respondent: 6.71.
    Estimated annual number of responses: 1,330.
    Estimated total annual burden on respondents: 920 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.)
    Copies of this information collection can be obtained from Ms. 
Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 
851-2727.

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 proposed rule, please contact Ms. Kimberly 
Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.

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.


Sec.  319.56-38  [Amended]

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 (e), by adding the word ``lemons,'' between the words 
``grapefruit,'' and ``mandarins,''.
0
c. In paragraph (f), by adding the word ``lemons,'' between the words 
``grapefruit,'' and ``mandarins,''.

    Done in Washington, DC, this 29th day of March 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-07673 Filed 4-1-16; 8:45 am]
 BILLING CODE 3410-34-P



                                                                              Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules                                                  19063

                                                    Kimberly Hardy, APHIS’ Information                      leaves must be collected from each                     packing containers from each
                                                    Collection Coordinator, at (301) 851–                   registered production site under the                   consignment will be selected by the
                                                    2727.                                                   direction of the NPPO of Chile. These                  NPPO of Chile, and the fruit from these
                                                                                                            samples must undergo a pest detection                  boxes, crates, or other APHIS-approved
                                                    List of Subjects in 7 CFR Part 319
                                                                                                            and evaluation method as follows: The                  packing containers will be visually
                                                      Coffee, Cotton, Fruits, Imports, Logs,                leaves must be washed using a flushing                 inspected for quarantine pests. If a
                                                    Nursery stock, Plant diseases and pests,                method, placed in a 20-mesh sieve on                   single live B. chilensis mite is found
                                                    Quarantine, Reporting and                               top of a 200-mesh sieve, sprinkled with                during the inspection process, the
                                                    recordkeeping requirements, Rice,                       a liquid soap and water solution,                      certified low-prevalence production site
                                                    Vegetables.                                             washed with water at high pressure, and                where the fruit was grown will lose its
                                                      Accordingly, we propose to amend 7                    washed with water at low pressure. The                 certification for the remainder of the
                                                    CFR part 319 as follows:                                process must then be repeated. The                     harvest season.
                                                                                                            contents of the 200-mesh sieve must                      (v) Phytosanitary certificate. Each
                                                    PART 319—FOREIGN QUARANTINE                             then be placed on a petri dish and                     consignment of fresh cherimoya fruit
                                                    NOTICES                                                 analyzed for the presence of live B.                   must be accompanied by a
                                                                                                            chilensis mites. If a single live B.                   phytosanitary certificate issued by the
                                                    ■ 1. The authority citation for part 319                chilensis mite is found, the production                NPPO of Chile that contains an
                                                    continues to read as follows:                           site will not qualify for certification as             additional declaration stating that the
                                                      Authority: 7 U.S.C. 450, 7701–7772, and               a low-prevalence production site. Each                 fruit in the consignment was inspected
                                                    7781–7786; 21 U.S.C. 136 and 136a; 7 CFR                production site may have only one                      and found free of Brevipalpus chilensis
                                                    2.22, 2.80, and 371.3.                                  opportunity per season to qualify as a                 and was grown, packed, and shipped in
                                                    ■ 2. Section 319.56–75 is added to                      low-prevalence production site, and                    accordance with the requirements of
                                                    subpart Fruits and Vegetables to read as                certification of low prevalence will be                § 319.56–75(b)(2).
                                                    follows:                                                valid for one harvest season only. The
                                                                                                                                                                     Done in Washington, DC, this 29th day of
                                                                                                            NPPO of Chile will present a list of                   March 2016.
                                                    § 319.56–75      Fresh cherimoya from Chile.            certified production sites to APHIS.
                                                                                                                                                                   Kevin Shea,
                                                       Fresh cherimoya (Annona cherimola)                   Fruit from those production sites that do
                                                    fruit must be imported into the United                  not meet the requirements for                          Administrator, Animal and Plant Health
                                                                                                                                                                   Inspection Service.
                                                    States under the conditions listed in                   certification as low-prevalence
                                                    paragraphs (a) and (b)(1) of this section.              production sites may still be imported                 [FR Doc. 2016–07653 Filed 4–1–16; 8:45 am]
                                                    Fresh cherimoya fruit may also be                       into the continental United States                     BILLING CODE 3410–34–P

                                                    imported into the continental United                    subject to treatment as listed in
                                                    States from Chile under the conditions                  paragraph (b)(1) of this section.
                                                    listed in paragraph (b)(2) of this section.                (iii) Post-harvest processing. After                DEPARTMENT OF AGRICULTURE
                                                       (a) Commercial consignments. The                     harvest, all damaged or diseased fruits
                                                                                                                                                                   Animal and Plant Health Inspection
                                                    fresh cherimoya fruit may be imported                   must be culled at the packinghouse and
                                                                                                                                                                   Service
                                                    in commercial consignments only.                        remaining fruit must be packed into
                                                       (b) The risks presented by Brevipalpus               new, clean boxes, crates, or other
                                                                                                                                                                   7 CFR Part 319
                                                    chilensis mites must be addressed in                    APHIS-approved packing containers.
                                                    one of the following ways:                                 (iv) Phytosanitary inspection. Fruit                [Docket No. APHIS–2015–0051]
                                                       (1) The fresh cherimoya fruit are                    must be inspected in Chile at an APHIS-
                                                                                                                                                                   RIN 0579–AE20
                                                    subject to treatment and certification                  approved inspection site under the
                                                    consisting of:                                          direction of APHIS inspectors in                       Importation of Lemons From Chile Into
                                                       (i) A soapy water and wax treatment.                 coordination with the NPPO of Chile                    the Continental United States
                                                       (ii) Each consignment of fresh                       following any post-harvest processing.
                                                    cherimoya fruit must be accompanied                     A biometric sample must be drawn and                   AGENCY:  Animal and Plant Health
                                                    by documentation to validate foreign                    examined from each consignment. Fresh                  Inspection Service, USDA.
                                                    site preclearance inspection after soapy                cherimoya fruit can be shipped to the                  ACTION: Proposed rule.
                                                    water and wax treatment completed in                    continental United States under the
                                                    Chile; or                                               conditions of this section only if the                 SUMMARY:    We are proposing to amend
                                                       (2) The fresh cherimoya fruit are                    consignment passes inspection. Any                     the fruits and vegetables regulations to
                                                    subject to a systems approach consisting                consignment that does not meet the                     list lemon (Citrus limon (L.) Burm. f.)
                                                    of the following:                                       requirements for inspection can still be               from Chile as eligible for importation
                                                       (i) Production site registration. The                imported into the continental United                   into the continental United States
                                                    production site where the fruit is grown                States subject to treatment as listed in               subject to a systems approach. Under
                                                    must be registered with the national                    paragraph (b)(1) of this section.                      this systems approach, the fruit would
                                                    plant protection organization (NPPO) of                 Inspection procedures are as follows:                  have to be grown in a place of
                                                    Chile. Harvested cherimoya must be                         (A) Fruit presented for inspection                  production that is registered with the
                                                    placed in field cartons or containers that              must be identified in the shipping                     Government of Chile and certified as
                                                    are marked to show the official                         documents accompanying each lot of                     having a low prevalence of Brevipalpus
                                                    registration number of the production                   fruit to specify the production site or                chilensis. The fruit would have to
mstockstill on DSK4VPTVN1PROD with PROPOSALS




                                                    site. Registration must be renewed                      sites in which the fruit was produced                  undergo pre-harvest sampling at the
                                                    annually.                                               and the packing shed or sheds in which                 registered production site. Following
                                                       (ii) Low-prevalence production site                  the fruit was processed. This                          post-harvest processing, the fruit would
                                                    certification. The fruit must originate                 identification must be maintained until                have to be inspected in Chile at an
                                                    from a low-prevalence production site                   the fruit is released for entry into the               approved inspection site. Each
                                                    to be imported under the conditions in                  United States.                                         consignment of fruit would have to be
                                                    this section. Between 1 and 30 days                        (B) A biometric sample of the boxes,                accompanied by a phytosanitary
                                                    prior to harvest, random samples of                     crates, or other APHIS-approved                        certificate with an additional


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                                                    19064                     Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules

                                                    declaration stating that the fruit had                  provisions, lemons from Chile (Citrus                  controlled.’’ In the CIED, the likelihood
                                                    been found free of Brevipalpus chilensis                limon (L.) Burm. f.) are currently listed              and consequences of introducing this
                                                    based on field and packinghouse                         in the FAVIR database as enterable                     pest to the United States are considered,
                                                    inspections. This proposed rule would                   subject to treatment with methyl                       and B. chilensis is rated as having a
                                                    allow for the safe importation of lemons                bromide for the pest Brevipalpus                       medium pest risk potential. Pests
                                                    from Chile using mitigation measures                    chilensis, the Chilean false red mite,                 receiving a rating within the medium
                                                    other than fumigation with methyl                       applied either as a condition of entry                 range may necessitate specific
                                                    bromide.                                                treatment or applied in Chile under an                 phytosanitary measures in addition to
                                                    DATES: We will consider all comments                    APHIS preclearance program.                            standard port-of-entry inspection of the
                                                    that we receive on or before June 3,                       The regulations in § 319.56–4(a) also               commodity being imported into the
                                                    2016.                                                   provide that commodities that require                  United States.
                                                                                                            phytosanitary measures other than those                   Based on the findings of our CIED, we
                                                    ADDRESSES: You may submit comments                      measures cited in § 319.56–4(b) may                    are proposing to allow the importation
                                                    by either of the following methods:                     only be imported in accordance with                    of fresh lemons from Chile into the
                                                       • Federal eRulemaking Portal: Go to                  applicable requirements in § 319.56–3                  United States subject to the same
                                                    http://www.regulations.gov/                             and commodity-specific requirements                    systems approach in place for other
                                                    #!docketDetail;D=APHIS-2015-0051.                       contained elsewhere in the subpart.                    citrus from Chile. Under a systems
                                                       • Postal Mail/Commercial Delivery:                   Under those provisions, other citrus                   approach, a set of phytosanitary
                                                    Send your comment to Docket No.                         fruits, including clementines (Citrus                  conditions, at least two of which have
                                                    APHIS–2015–0051, Regulatory Analysis                    reticulata Blanco var. Clementine),                    an independent effect in mitigating the
                                                    and Development, PPD, APHIS, Station                    mandarins (Citrus reticulata Blanco),                  pest risk associated with the movement
                                                    3A–03.8, 4700 River Road Unit 118,                      and tangerines (Citrus reticulata Blanco)              of commodities, is specified, whereby
                                                    Riverdale, MD 20737–1238.                               may be imported into the United States                 fruits and vegetables may be imported
                                                       Supporting documents and any
                                                                                                            from Chile, and grapefruit (Citrus                     into the United States from countries
                                                    comments we receive on this docket                      paradisi Macfad.) and sweet oranges                    that are not free of certain plant pests.
                                                    may be viewed at http://                                (Citrus sinensis (L.) Osbeck) may be                   The systems approach for lemons from
                                                    www.regulations.gov/                                    imported into the continental United                   Chile would require the fruit to be
                                                    #!docketDetail;D=APHIS-2015-0051 or                     States from Chile under a systems                      grown in a place of production that is
                                                    in our reading room, which is located in                approach. The conditions applicable to                 registered with the national plant
                                                    Room 1141 of the USDA South                             the importation of citrus from Chile are               protection organization (NPPO) of Chile.
                                                    Building, 14th Street and Independence                  listed in § 319.56–38.                                 The fruit would have to undergo pre-
                                                    Avenue SW., Washington, DC. Normal                         In this document, we are proposing to               harvest sampling at the registered
                                                    reading room hours are 8 a.m. to 4:30                   amend § 319.56–38 to include lemons                    production site under the direction of
                                                    p.m., Monday through Friday, except                     that are currently enterable into the                  the NPPO of Chile. The NPPO of Chile
                                                    holidays. To be sure someone is there to                United States subject to treatment,                    would present a list of production sites
                                                    help you, please call (202) 799–7039                    thereby making the lemons eligible for                 certified as having a low prevalence of
                                                    before coming.                                          importation under the same systems                     B. chilensis to APHIS. Following post-
                                                    FOR FURTHER INFORMATION CONTACT: Mr.                    approach as other citrus from Chile.                   harvest processing, the fruit would have
                                                    George Balady, Senior Regulatory Policy                    Our review of the information                       to be inspected in Chile at an APHIS-
                                                    Specialist, Regulatory Coordination and                 supporting the safe importation into the               approved inspection site under the
                                                    Compliance, Plant Health Programs,                      United States of citrus from Chile under               direction of APHIS inspectors in
                                                    PPQ, APHIS, 4700 River Road Unit 133,                   the listed phytosanitary measures is                   coordination with the NPPO of Chile.
                                                    Riverdale, MD 20737; (301) 851–2240.                    examined in a commodity import                         Each consignment of the fruit would
                                                    SUPPLEMENTARY INFORMATION:                              evaluation document (CIED) titled                      have to be accompanied by a
                                                                                                            ‘‘Importation of Fresh Lemons (Citrus                  phytosanitary certificate with an
                                                    Background                                              limon (L.) Burm. F.), from Chile into the              additional declaration stating that the
                                                       Under the regulations in ‘‘Subpart-                  Continental United States Using a                      lemons in the consignment meet the
                                                    Fruits and Vegetables’’ (7 CFR 319.56–                  Systems Approach.’’ Copies of the CIED                 conditions of the systems approach and
                                                    1 through 319.56–74, referred to below                  may be obtained from the person listed                 are free of B. chilensis. The mitigation
                                                    as the regulations), the Animal and                     under FOR FURTHER INFORMATION                          measures in the proposed systems
                                                    Plant Health Inspection Service (APHIS)                 CONTACT or viewed on the                               approach are discussed in greater detail
                                                    of the U.S. Department of Agriculture                   Regulations.gov Web site or in our                     below.
                                                    prohibits or restricts the importation of               reading room (see ADDRESSES above for
                                                    fruits and vegetables into the United                   a link to Regulations.gov and                          Production Site Registration
                                                    States from certain parts of the world to               information on the location and hours of                 The production site where the lemons
                                                    prevent plant pests from being                          the reading room).                                     are grown would have to be registered
                                                    introduced into and spread within the                      In June 2010, APHIS recognized all of               with the NPPO of Chile. To register, the
                                                    United States.                                          Chile as a pest-free area with respect to              production site must provide the NPPO
                                                       The regulations in § 319.56–4(a)                     Ceratitis capitata, the Mediterranean                  of Chile with the following information:
                                                    provide that fruits and vegetables that                 fruit fly. Therefore, the CIED identifies              Production site name, grower name,
                                                    can be imported using one or more of                    one quarantine pest that could be                      municipality, province, region, area
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                                                    the designated phytosanitary measures                   introduced into the United States in                   planted to each species, number of
                                                    in § 319.56–4(b) to mitigate risk will be               consignments of lemon from Chile: B.                   plants/hectares/species, and
                                                    listed, along with the applicable                       chilensis. A quarantine pest is defined                approximate date of harvest.
                                                    requirements for their importation, on                  in § 319.56–2 as ‘‘a pest of potential                 Registration would have to be renewed
                                                    the Internet (currently in the Fruits and               economic importance to the area                        annually.
                                                    Vegetables Import Requirements                          endangered thereby and not yet present                   Registration of production sites is
                                                    [FAVIR] database at                                     there, or present but not widely                       required to manage production site
                                                    www.aphis.usda.gov/favir). Under those                  distributed and being officially                       requirements and to control access to


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                                                                              Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules                                             19065

                                                    the program to only qualified sites.                    exported to the United States but would                proposed rule is not expected to result
                                                    Commercially grown shipments from                       require fumigation with methyl bromide                 in a significant increase in Chilean
                                                    registered production sites use good                    either in Chile or at the port of first                lemon exports to the United States or
                                                    agricultural practices to reduce or                     arrival in the United States in                        their competitiveness.
                                                    eliminate pests.                                        accordance with § 305.5 of the                            Under these circumstances, the
                                                                                                            regulations.                                           Administrator of the Animal and Plant
                                                    Low-Prevalence Production Site                                                                                 Health Inspection Service has
                                                    Certification                                           Phytosanitary Certificate                              determined that this action would not
                                                       Between 1 and 30 days prior to                         Each consignment of fruit would have                 have a significant economic impact on
                                                    harvest, random samples of fruit would                  to be accompanied by a phytosanitary                   a substantial number of small entities.
                                                    have to be collected from each                          certificate issued by the NPPO of Chile
                                                    registered production site under the                    that contains an additional declaration                Executive Order 12988
                                                    direction of the NPPO of Chile. These                   stating that the lemons in the                            This proposed rule would allow
                                                    samples would have to undergo a pest                    consignment meet the conditions of the                 lemon fruit to be imported into the
                                                    detection and evaluation method as                      systems approach and are free of B.                    continental United States from Chile. If
                                                    follows: The fruit would have to be                     chilensis. Requiring a phytosanitary                   this proposed rule is adopted, State and
                                                    washed using a flushing method, placed                  certificate ensures that the NPPO of                   local laws and regulations regarding
                                                    in a 20-mesh sieve on top of a 200-mesh                 Chile inspects the lemons for pests.                   lemon fruit imported under this rule
                                                    sieve, sprinkled with a liquid soap and                                                                        would be preempted while the fruit is
                                                    water solution, washed with water at                    Executive Order 12866 and Regulatory                   in foreign commerce. Fresh fruits are
                                                    high pressure, and washed with water at                 Flexibility Act                                        generally imported for immediate
                                                    low pressure. The washing process                          This proposed rule has been                         distribution and sale to the consuming
                                                    would then be repeated immediately                      determined to be not significant for the               public and would remain in foreign
                                                    after the first washing. The contents of                purposes of Executive Order 12866 and,                 commerce until sold to the ultimate
                                                    the 200-mesh sieve would then be                        therefore, has not been reviewed by the                consumer. The question of when foreign
                                                    placed on a petri dish and analyzed for                 Office of Management and Budget.                       commerce ceases in other cases must be
                                                    the presence of live B. chilensis mites.                   In accordance with the Regulatory                   addressed on a case-by-case basis. If this
                                                    If a single live B. chilensis mite is found,            Flexibility Act, we have analyzed the                  proposed rule is adopted, no retroactive
                                                    the production site would not qualify                   potential economic effects of this action              effect will be given to this rule, and this
                                                    for certification as a low-prevalence                   on small entities. The analysis is                     rule will not require administrative
                                                    production site and would be eligible to                summarized below. Copies of the full                   proceedings before parties may file suit
                                                    export fruit to the United States only if               analysis are available by contacting the               in court challenging this rule.
                                                    the fruit is fumigated with methyl                      person listed under FOR FURTHER
                                                                                                                                                                   Paperwork Reduction Act
                                                    bromide either in Chile or at the port of               INFORMATION CONTACT or on the
                                                    first arrival in the United States. Each                Regulations.gov Web site (see                            In accordance with section 3507(d) of
                                                    production site would have only one                     ADDRESSES above for instructions for                   the Paperwork Reduction Act of 1995
                                                    opportunity per season to qualify as a                  accessing Regulations.gov).                            (44 U.S.C. 3501 et seq.), the information
                                                    low-prevalence production site, and                        The Government of Chile submitted a                 collection or recordkeeping
                                                    certification of low prevalence would be                market access request for lemon fruit to               requirements included in this proposed
                                                    valid for one harvest season only. The                  be approved for import into the                        rule have been submitted for approval to
                                                    NPPO of Chile would be required to                      continental United States using a                      the Office of Management and Budget
                                                    present a list of certified production                  systems approach as an alternative to                  (OMB). Please send written comments
                                                    sites to APHIS annually.                                methyl bromide fumigation, to mitigate                 to the Office of Information and
                                                                                                            the risk of introduction of the Chilean                Regulatory Affairs, OMB, Attention:
                                                    Post-Harvest Processing                                 false red mite.                                        Desk Officer for APHIS, Washington, DC
                                                       After harvest and before packing, the                   The United States is a net exporter of              20503. Please state that your comments
                                                    fruit would have to be washed, rinsed                   fresh lemon; over 5 seasons (2009/10–                  refer to Docket No. APHIS–2015–0051.
                                                    in a potable water bath, washed with                    2013/14), annual exports averaged about                Please send a copy of your comments to:
                                                    detergent with brushing using bristle                   102,410 metric tons (MT) (19 percent of                (1) APHIS, using one of the methods
                                                    rollers, rinsed with a hot water shower                 production), compared to annual                        described under ADDRESSES at the
                                                    with brushing using bristle rollers,                    imports that averaged about 46,270 MT.                 beginning of this document, and (2)
                                                    predried at room temperature, waxed,                    Based on the Small Business                            Clearance Officer, OCIO, USDA, Room
                                                    and dried with hot air. These                           Administration small-entity standards,                 404–W, 14th Street and Independence
                                                    mitigations aid in removing any pests                   the majority of entities that comprise                 Avenue SW., Washington, DC 20250.
                                                    from the fruit.                                         industries that may be affected by this                  APHIS is proposing to amend the
                                                                                                            rule are small. These entities include                 fruits and vegetables regulations to list
                                                    Phytosanitary Inspection                                lemon producers, packers, wholesalers,                 lemon (Citrus limon (L.) Burm. f.) from
                                                      The fruit would have to be inspected                  retailers, and importers.                              Chile as eligible for importation into the
                                                    in Chile at an APHIS-approved                              Chile supplies about one-third of U.S.              continental United States subject to a
                                                    inspection site under the direction of                  fresh lemon imports. Chile’s Ministry of               systems approach. Under this systems
                                                    APHIS inspectors in coordination with                   Agriculture estimates that                             approach, the fruit would have to be
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                                                    the NPPO of Chile following any post-                   approximately 60 percent of their lemon                grown in a place of production that is
                                                    harvest processing. A biometric sample                  consignments to the United States will                 registered with the Government of Chile
                                                    would be drawn from each                                switch from methyl bromide treatment                   and certified as having a low prevalence
                                                    consignment, which may represent                        to the systems approach. Chile currently               of B. chilensis. The fruit would have to
                                                    multiple grower lots from different                     exports about 15,000 MT per year to the                undergo pre-harvest sampling at the
                                                    packing sheds. Consignments with                        United States, of which the systems                    registered production site. Following
                                                    mites will be rejected from the systems                 approach is expected to be used for                    post-harvest processing, the fruit would
                                                    approach. Rejected lots may still be                    8,500 to 9,000 MT. For this reason, the                have to be inspected in Chile at an


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                                                    19066                     Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules

                                                    approved inspection site. Each                          E-Government Act Compliance                            DEPARTMENT OF HEALTH AND
                                                    consignment of fruit would have to be                                                                          HUMAN SERVICES
                                                    accompanied by a phytosanitary                             The Animal and Plant Health
                                                    certificate with an additional                          Inspection Service is committed to                     Food and Drug Administration
                                                    declaration stating that the fruit had                  compliance with the E-Government Act
                                                    been found free of B. chilensis based on                to promote the use of the Internet and                 21 CFR Part 56
                                                    field and packinghouse inspections.                     other information technologies, to                     [Docket No. FDA–2015–N–5052]
                                                    This proposed rule would allow for the                  provide increased opportunities for
                                                    safe importation of lemons from Chile                   citizen access to Government                           Administrative Actions for
                                                    using mitigation measures other than                    information and services, and for other                Noncompliance; Lesser Administrative
                                                    fumigation with methyl bromide.                         purposes. For information pertinent to                 Actions
                                                       Implementing this rule will require                  E-Government Act compliance related
                                                                                                                                                                   AGENCY:   Food and Drug Administration,
                                                    permits, production site registration                   to this proposed rule, please contact Ms.
                                                                                                                                                                   HHS.
                                                    with low-prevalence level certification                 Kimberly Hardy, APHIS’ Information
                                                    option, phytosanitary inspections,                                                                             ACTION:   Proposed rule.
                                                                                                            Collection Coordinator, at (301) 851–
                                                    phytosanitary certificates, and chemical                2727.                                                  SUMMARY:   The Food and Drug
                                                    treatment procedures.                                                                                          Administration (FDA) is proposing to
                                                       We are soliciting comments from the                  List of Subjects in 7 CFR Part 319
                                                                                                                                                                   amend the regulation describing lesser
                                                    public (as well as affected agencies)                     Coffee, Cotton, Fruits, Imports, Logs,               administrative actions that may be
                                                    concerning our proposed information                     Nursery stock, Plant diseases and pests,               imposed on an Institutional Review
                                                    collection and recordkeeping                            Quarantine, Reporting and                              Board (IRB) that has failed to comply
                                                    requirements. These comments will                                                                              with FDA’s IRB regulations. We are
                                                                                                            recordkeeping requirements, Rice,
                                                    help us:                                                                                                       clarifying that FDA may require the IRB
                                                                                                            Vegetables.
                                                       (1) Evaluate whether the proposed                                                                           to withhold approval of new FDA-
                                                    information collection is necessary for                   Accordingly, we propose to amend 7                   regulated studies, stop the enrollment of
                                                    the proper performance of our agency’s                  CFR part 319 as follows:                               new subjects in ongoing studies, and
                                                    functions, including whether the                                                                               terminate ongoing studies, or any
                                                    information will have practical utility;                PART 319—FOREIGN QUARANTINE                            combination of these actions, until the
                                                       (2) Evaluate the accuracy of our                     NOTICES                                                noncompliance with FDA’s IRB
                                                    estimate of the burden of the proposed                                                                         regulations is corrected. We are taking
                                                    information collection, including the                   ■ 1. The authority citation for part 319               this action to ensure clarity and improve
                                                    validity of the methodology and                         continues to read as follows:                          the accuracy of the regulations.
                                                    assumptions used;                                         Authority: 7 U.S.C. 450, 7701–7772, and              DATES: Submit electronic or written
                                                       (3) Enhance the quality, utility, and                7781–7786; 21 U.S.C. 136 and 136a; 7 CFR               comments on this proposed rule or its
                                                    clarity of the information to be                        2.22, 2.80, and 371.3.                                 companion direct final rule by June 20,
                                                    collected; and                                                                                                 2016.
                                                       (4) Minimize the burden of the                       § 319.56–38       [Amended]                            ADDRESSES: You may submit comments
                                                    information collection on those who are                 ■  2. Section 319.56–38 is amended as                  as follows:
                                                    to respond (such as through the use of                  follows:                                               Electronic Submissions
                                                    appropriate automated, electronic,
                                                    mechanical, or other technological                      ■ a. In the introductory text, by adding                 Submit electronic comments in the
                                                    collection techniques or other forms of                 the words ‘‘, lemons (Citrus limon (L.)                following way:
                                                    information technology; e.g., permitting                Burm. f.),’’ between the words ‘‘(Citrus                 • Federal eRulemaking Portal: http://
                                                    electronic submission of responses).                    paradisi Macfad.)’’ and ‘‘and sweet                    www.regulations.gov. Follow the
                                                       Estimate of burden: Public reporting                 oranges’’.                                             instructions for submitting comments.
                                                    burden for this collection of information               ■ b. In paragraph (e), by adding the
                                                                                                                                                                   Comments submitted electronically,
                                                    is estimated to average 0.6917 hours per                                                                       including attachments, to http://
                                                                                                            word ‘‘lemons,’’ between the words
                                                    response.                                                                                                      www.regulations.gov will be posted to
                                                                                                            ‘‘grapefruit,’’ and ‘‘mandarins,’’.
                                                                                                                                                                   the docket unchanged. Because your
                                                       Respondents: Producers and                           ■ c. In paragraph (f), by adding the word              comment will be made public, you are
                                                    importers of lemons, and the NPPO of                    ‘‘lemons,’’ between the words                          solely responsible for ensuring that your
                                                    Chile.
                                                                                                            ‘‘grapefruit,’’ and ‘‘mandarins,’’.                    comment does not include any
                                                       Estimated annual number of                                                                                  confidential information that you or a
                                                    respondents: 198.                                         Done in Washington, DC, this 29th day of
                                                                                                            March 2016.                                            third party may not wish to be posted,
                                                       Estimated annual number of                                                                                  such as medical information, your or
                                                    responses per respondent: 6.71.                         Kevin Shea,
                                                                                                                                                                   anyone else’s Social Security number, or
                                                       Estimated annual number of                           Administrator, Animal and Plant Health                 confidential business information, such
                                                    responses: 1,330.                                       Inspection Service.
                                                                                                                                                                   as a manufacturing process. Please note
                                                       Estimated total annual burden on                     [FR Doc. 2016–07673 Filed 4–1–16; 8:45 am]             that if you include your name, contact
                                                    respondents: 920 hours. (Due to                                                                                information, or other information that
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                                                                                                            BILLING CODE 3410–34–P
                                                    averaging, the total annual burden hours                                                                       identifies you in the body of your
                                                    may not equal the product of the annual                                                                        comments, that information will be
                                                    number of responses multiplied by the                                                                          posted on http://www.regulations.gov.
                                                    reporting burden per response.)                                                                                  • If you want to submit a comment
                                                       Copies of this information collection                                                                       with confidential information that you
                                                    can be obtained from Ms. Kimberly                                                                              do not wish to be made available to the
                                                    Hardy, APHIS’ Information Collection                                                                           public, submit the comment as a
                                                    Coordinator, at (301) 851–2727.                                                                                written/paper submission and in the


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Document Created: 2016-04-02 03:53:02
Document Modified: 2016-04-02 03:53:02
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesWe will consider all comments that we receive on or before June 3, 2016.
ContactMr. George Balady, Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, Plant Health Programs, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 851-2240.
FR Citation81 FR 19063 
RIN Number0579-AE20
CFR AssociatedCoffee; Cotton; Fruits; Imports; Logs; Nursery Stock; Plant Diseases and Pests; Quarantine; Reporting and Recordkeeping Requirements; Rice and Vegetables

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