[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Rules and Regulations]
[Pages 22463-22465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-9067]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Rules
and Regulations
[[Page 22463]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
7 CFR Part 319
[Docket No. APHIS-2010-0036]
RIN 0579-AD27
Importation of Clementines From Spain; Amendment to Inspection
Provisions
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: We are amending the regulations governing the importation of
clementines from Spain by removing from the regulations the number of
clementines per consignment intended for export to the United States
that are required to be sampled by inspectors of the Animal and Plant
Health Inspection Service (APHIS). In place of this number, we will
state in the regulations that inspectors will cut and inspect a sample
of clementines determined by APHIS. By removing from the regulations
the number of clementines per consignment from Spain to be sampled, we
will have the flexibility to respond to changing risk levels while
continuing to provide protection against the introduction of quarantine
pests.
DATES: Effective Date: May 16, 2012.
FOR FURTHER INFORMATION CONTACT: Mr. Paul McGowan, Operational
Director, Preclearance and Offshore Programs, PPQ, APHIS, 4700 River
Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2312.
SUPPLEMENTARY INFORMATION:
Background
The regulations in ``Subpart-Fruits and Vegetables'' (7 CFR 319.56-
1 through 319.56-54, referred to below as the regulations) prohibit or
restrict the importation of fruits and vegetables into the United
States from certain parts of the world to prevent the introduction and
spread of plant pests that are new to or not widely distributed within
the United States.
The regulations in Sec. 319.56-34 list specific requirements for
the importation into the United States of clementines from Spain, one
of which is that 200 clementines from each consignment be cut and
inspected (i.e., sampled) before undergoing cold treatment. The purpose
of this inspection is to detect live Mediterranean fruit flies
(Ceratitis capitata, or Medfly) in any stage of development that may be
present. If a single live Medfly is found in any stage of development,
the entire consignment is rejected.
On December 29, 2010, we published in the Federal Register (75 FR
81942-81943, Docket No. APHIS-2010-0036) a proposal \1\ to amend the
regulations by removing the requirement in Sec. 319.56-34(f) that 200
fruit from each consignment be sampled by cutting before treatment and
replacing it with the statement that the number of fruit to be sampled
before treatment will be determined by the Animal and Plant Health
Inspection Service (APHIS). We explained in the proposal that this
change would give us the flexibility to raise or lower the fruit
sampling rate when conditions indicate a higher or lower risk of
Medfly. With this change, we stated that we would be able to adjust the
sampling rate and thereby detect pests that might otherwise go
undetected prior to treatment. We also stated that the actual sampling
rate would continue to be included in the workplan agreed to by APHIS
and the Government of Spain, which describes in detail how the
regulations are implemented operationally.
---------------------------------------------------------------------------
\1\ To view the proposed rule, the economic analysis, and the
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-;2010-0036.
---------------------------------------------------------------------------
We solicited comments concerning our proposal for 60 days ending
February 28, 2011. We received three comments by that date. They were
from the national plant protection organization (NPPO) of Spain, a
domestic citrus trade association, and a group of students. All opposed
our proposal to remove the set number of 200 fruit and replace it with
a statement that the number of fruit to be sampled will be determined
by APHIS.
Two commenters stated that our proposal contained no objective
criteria on which to base increases in the sampling rate or to evaluate
the risk level of Medfly. One of these commenters, the NPPO of Spain,
noted that they and APHIS had signed a bilateral workplan in October
2010, in which both parties agreed that sampling 200 fruit per
consignment would provide a 95 percent confidence level of detecting a
1.5 percent infestation level. The Spanish NPPO expressed concern that
the lack of specific criteria in our proposed change to the regulations
could be difficult to interpret and lead to disruptions in Spanish
exports.
We have subsequently held discussions with the Government of Spain
regarding specific confidence and infestation levels. Changes in the
sampling rate to achieve agreed-upon target levels will be based on
internationally recognized sampling methodologies \2\ and included in
an annex to the bilateral workplan.
---------------------------------------------------------------------------
\2\ International Standards for Phytosanitary Measures, ISPM No.
31: Methodologies for Sampling of Consignments (2008): https://www.ippc.int/file_uploaded/1229532867492_ISPM31_2008_E.pdf.
---------------------------------------------------------------------------
The same commenter recommended that target detection levels and
sampling rates should be negotiated within the sphere of annual
bilateral meetings with APHIS rather than set through rulemaking.
It was necessary for us to propose changing the regulations
themselves because they require the use of a single, invariable
sampling rate. With the change we are making to the regulations in this
final rule, we will have the flexibility to make future adjustments to
sampling rates in the context of bilateral discussions with the
Government of Spain.
Another commenter noted that the current sampling rate of 200 fruit
was established based on a scientific risk assessment, and that if a
smaller sample is taken without conducting a similar assessment APHIS
may not be able to determine the efficacy of the inspection process
until Medfly are found in the channels of distribution. The commenter
recommended that, for those reasons, 200 fruit per consignment be the
minimum required sampling rate.
We are making no changes in response to this comment. In most of
[[Page 22464]]
our systems approaches for importing fruits and vegetables that involve
sampling of fruit prior to export, we do not specify the sampling rate
in the regulations; instead, fruit is sampled at a rate agreed upon by
the NPPO of the exporting country and APHIS and contained in the
bilateral workplan. This final rule will make our approach with respect
to sampling clementines from Spain consistent with other systems
approaches for fruits and vegetables set out in the regulations.
The scientific risk assessment that established the 200 fruit
sample indicated that such a sample would give us a 95 percent
confidence rate of detecting a 1.5 percent level of infestation. The
risk assessment determined that such a detection rate would be
sufficient to ensure that Medfly populations in the clementines were
low enough to be mitigated by the subsequent required cold treatment.
The sampling rate change we proposed was prompted by the desire to
increase the number of fruit sampled and thus increase the confidence
that we were detecting any shipments with an infestation rate of 1.5
percent or more. We anticipate using the greater flexibility provided
by this final rule to allow for such increases, when conditions
warrant.
In the other systems approaches in the regulations that include
sampling of fruits and vegetables, we only lower the initial sampling
rate after years of few or no pest detections have established a
definitive record of low pest prevalence in the commodity. At some
point, conditions may warrant sampling a lower number of clementines
from Spain, thus providing a lower level of confidence that the
sampling method is detecting all consignments of fruit with a 1.5
percent or more infestation level. For that reason, it is appropriate
that the regulations provide the flexibility to reduce the sampling
rate.
If we were to determine that lowering the sampling rate for Spanish
clementines was warranted, we would share the data that led to our
determination with our domestic stakeholders and State partners prior
to finalizing any adjustments with the NPPO of Spain. After the
sampling rate was lowered, we would continue to monitor inspection
results closely; if detections were to increase, we would promptly
return the number of fruit sampled to 200 per consignment or more,
depending on conditions.
The NPPO of Spain expressed concern that an increase in the
sampling rate would require more time for APHIS inspectors to sample
the additional fruit, potentially resulting in costly treatment and
shipping delays.
If the sampling rate is increased in order to detect infestations
of Medfly that might otherwise go undetected, we estimate that the
number of additional fruit to be sampled would not be so high as to
cause significant delays in treating or shipping consignments of fruit.
A consignment of clementines consists of one or more lots containing no
more than a combined total of 200,000 boxes of clementines that are
presented to an inspector for pre-treatment inspection. Under the
current regulations, the percentage of sampled clementines ranges from
0.02 percent to 0.1 percent per consignment inspected. Even if
inspection amounts were to be increased two or three times, the
sampling rate would still be well under 1 percent of the consignment.
Another commenter asked whether we intended to establish timeframes
for increasing the sampling rate and, if so, how those timeframes would
be determined.
We have no plans to establish timeframes in conjunction with any
changes to the clementine sampling rate. They will be changed on the
basis of changing risk, as discussed earlier.
Another commenter stated that any reduction in the sampling rate
may result in higher pest control costs and cause inspectors to bow to
budgetary pressures by reducing inspections in an arbitrary or
capricious way.
We have no indications that inspectors would approach inspections
in this way due to any budgetary pressures. Inspectors authorized by
APHIS are required to follow a well-defined, scientifically based
inspection protocol.
Therefore, for the reasons given in the proposed rule and in this
document, we are adopting the proposed rule as a final rule, without
change.
Executive Order 12866 and Regulatory Flexibility Act
This final rule has been determined to be not significant for the
purposes of Executive Order 12866 and, therefore, has not been reviewed
by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed
the potential economic effects of this action on small entities. The
analysis is summarized below. Copies of the full analysis are available
on the Regulations.gov Web site (see footnote 1 in this document for a
link to Regulations.gov) or by contacting the person listed under FOR
FURTHER INFORMATION CONTACT.
A consignment of clementines consists of one or more lots
containing no more than a combined total of 200,000 boxes of
clementines that are presented to an inspector for pretreatment
inspection. Under the regulations that require sampling of 200
clementines, the percentage of sampled clementines ranges from 0.02
percent to 0.1 percent per consignment inspected. Even if inspection
amounts are increased 2 or 3 times when there is a higher pest risk,
the sampling rate will still be under 1 percent of the consignment.
While this rule will help reduce the risk of pest introduction, we
are unable to quantify the economic impact of decreasing the
probability of introducing Medfly into the United States. Medfly
introductions can be very costly to producers and to the Federal and
State Governments. The mean cost of eradicating six Medfly outbreaks in
2007 was $13.54 million.
This rule will not have a significant economic effect on producers
of clementines or other U.S. entities, regardless of their size or
resources. As described, an adjustment in the number of fruit sampled
will have a negligible effect on the number of clementines imported
from Spain.
Under these circumstances, the Administrator of the Animal and
Plant Health Inspection Service has determined that this action will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. This rule: (1) Preempts all State and local laws
and regulations that are inconsistent with this rule; (2) has no
retroactive effect; and (3) does not require administrative proceedings
before parties may file suit in court challenging this rule.
Paperwork Reduction Act
This final rule contains no information collection or recordkeeping
requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
et seq.).
List of Subjects in 7 CFR Part 319
Coffee, Cotton, Fruits, Imports, Logs, Nursery stock, Plant
diseases and pests, Quarantine, Reporting and recordkeeping
requirements, Rice, Vegetables.
Accordingly, we are amending 7 CFR part 319 as follows:
[[Page 22465]]
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. 319.56-34 [Amended]
0
2. In Sec. 319.56-34, paragraph (f) is amended as follows:
0
a. In the paragraph heading, by removing the words ``; rates of
inspection''.
0
b. By removing the words ``200 fruit'' and adding in their place the
words ``a sample of clementines determined by APHIS''.
Done in Washington, DC, this 9th day of April 2012.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2012-9067 Filed 4-13-12; 8:45 am]
BILLING CODE 3410-34-P