Importation of Lemons From Chile Into the Continental United States, 19063-19066 [2016-07673]
Download as PDF
Federal Register / Vol. 81, No. 64 / Monday, April 4, 2016 / Proposed Rules
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
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.
2. Section 319.56–75 is added to
subpart Fruits and Vegetables to read as
follows:
■
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§ 319.56–75
Fresh cherimoya from Chile.
Fresh cherimoya (Annona cherimola)
fruit must be imported into the United
States under the conditions listed in
paragraphs (a) and (b)(1) of this section.
Fresh cherimoya fruit may also be
imported into the continental United
States from Chile under the conditions
listed in paragraph (b)(2) of this section.
(a) Commercial consignments. The
fresh cherimoya fruit may be imported
in commercial consignments only.
(b) The risks presented by Brevipalpus
chilensis mites must be addressed in
one of the following ways:
(1) The fresh cherimoya fruit are
subject to treatment and certification
consisting of:
(i) A soapy water and wax treatment.
(ii) Each consignment of fresh
cherimoya fruit must be accompanied
by documentation to validate foreign
site preclearance inspection after soapy
water and wax treatment completed in
Chile; or
(2) The fresh cherimoya fruit are
subject to a systems approach consisting
of the following:
(i) Production site registration. The
production site where the fruit is grown
must be registered with the national
plant protection organization (NPPO) of
Chile. Harvested cherimoya must be
placed in field cartons or containers that
are marked to show the official
registration number of the production
site. Registration must be renewed
annually.
(ii) Low-prevalence production site
certification. The fruit must originate
from a low-prevalence production site
to be imported under the conditions in
this section. Between 1 and 30 days
prior to harvest, random samples of
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leaves must be collected from each
registered production site under the
direction of the NPPO of Chile. These
samples must undergo a pest detection
and evaluation method as follows: The
leaves must 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
process must then be repeated. The
contents of the 200-mesh sieve must
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 will not qualify for certification as
a low-prevalence production site. Each
production site may have only one
opportunity per season to qualify as a
low-prevalence production site, and
certification of low prevalence will be
valid for one harvest season only. The
NPPO of Chile will present a list of
certified production sites to APHIS.
Fruit from those production sites that do
not meet the requirements for
certification as low-prevalence
production sites may still be imported
into the continental United States
subject to treatment as listed in
paragraph (b)(1) of this section.
(iii) Post-harvest processing. After
harvest, all damaged or diseased fruits
must be culled at the packinghouse and
remaining fruit must be packed into
new, clean boxes, crates, or other
APHIS-approved packing containers.
(iv) Phytosanitary inspection. Fruit
must be inspected in Chile at an APHISapproved inspection site under the
direction of APHIS inspectors in
coordination with the NPPO of Chile
following any post-harvest processing.
A biometric sample must be drawn and
examined from each consignment. Fresh
cherimoya fruit can be shipped to the
continental United States under the
conditions of this section only if the
consignment passes inspection. Any
consignment that does not meet the
requirements for inspection can still be
imported into the continental United
States subject to treatment as listed in
paragraph (b)(1) of this section.
Inspection procedures are as follows:
(A) Fruit presented for inspection
must be identified in the shipping
documents accompanying each lot of
fruit to specify the production site or
sites in which the fruit was produced
and the packing shed or sheds in which
the fruit was processed. This
identification must be maintained until
the fruit is released for entry into the
United States.
(B) A biometric sample of the boxes,
crates, or other APHIS-approved
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packing containers from each
consignment will be selected by the
NPPO of Chile, and the fruit from these
boxes, crates, or other APHIS-approved
packing containers will be visually
inspected for quarantine pests. If a
single live B. chilensis mite is found
during the inspection process, the
certified low-prevalence production site
where the fruit was grown will lose its
certification for the remainder of the
harvest season.
(v) Phytosanitary certificate. Each
consignment of fresh cherimoya fruit
must be accompanied by a
phytosanitary certificate issued by the
NPPO of Chile that contains an
additional declaration stating that the
fruit in the consignment was inspected
and found free of Brevipalpus chilensis
and was grown, packed, and shipped in
accordance with the requirements of
§ 319.56–75(b)(2).
Done in Washington, DC, this 29th day of
March 2016.
Kevin Shea,
Administrator, Animal and Plant Health
Inspection Service.
[FR Doc. 2016–07653 Filed 4–1–16; 8:45 am]
BILLING CODE 3410–34–P
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
Animal and Plant Health
Inspection Service, USDA.
ACTION: Proposed rule.
AGENCY:
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
SUMMARY:
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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
https://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 https://
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 ‘‘SubpartFruits 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 § 319.56–4(a)
provide that fruits and vegetables that
can be imported using one or more of
the designated phytosanitary measures
in § 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
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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 § 319.56–4(a) also
provide that commodities that require
phytosanitary measures other than those
measures cited in § 319.56–4(b) may
only be imported in accordance with
applicable requirements in § 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 § 319.56–38.
In this document, we are proposing to
amend § 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 § 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
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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 preharvest 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 postharvest processing, the fruit would have
to be inspected in Chile at an APHISapproved 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
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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.
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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 postharvest 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
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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 § 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
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19065
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
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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.
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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
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.
§ 319.56–38
[Amended]
2. Section 319.56–38 is amended as
follows:
■ 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’’.
■ b. In paragraph (e), by adding the
word ‘‘lemons,’’ between the words
‘‘grapefruit,’’ and ‘‘mandarins,’’.
■ 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
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 56
[Docket No. FDA–2015–N–5052]
Administrative Actions for
Noncompliance; Lesser Administrative
Actions
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Proposed rule.
The Food and Drug
Administration (FDA) is proposing to
amend the regulation describing lesser
administrative actions that may be
imposed on an Institutional Review
Board (IRB) that has failed to comply
with FDA’s IRB regulations. We are
clarifying that FDA may require the IRB
to withhold approval of new FDAregulated studies, stop the enrollment of
new subjects in ongoing studies, and
terminate ongoing studies, or any
combination of these actions, until the
noncompliance with FDA’s IRB
regulations is corrected. We are taking
this action to ensure clarity and improve
the accuracy of the regulations.
DATES: Submit electronic or written
comments on this proposed rule or its
companion direct final rule by June 20,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
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Agencies
[Federal Register Volume 81, Number 64 (Monday, April 4, 2016)]
[Proposed Rules]
[Pages 19063-19066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://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 https://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
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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]
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2. Section 319.56-38 is amended as follows:
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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''.
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b. In paragraph (e), by adding the word ``lemons,'' between the words
``grapefruit,'' and ``mandarins,''.
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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