[Federal Register Volume 77, Number 73 (Monday, April 16, 2012)]
[Rules and Regulations]
[Pages 22463-22465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-9067]

Rules and Regulations
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Federal Register / Vol. 77, No. 73 / Monday, April 16, 2012 / Rules 
and Regulations

[[Page 22463]]


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 

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 

DATES: Effective Date: May 16, 2012.

Director, Preclearance and Offshore Programs, PPQ, APHIS, 4700 River 
Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2312.



    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 
    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 
    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 
    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 
    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 

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 
    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 

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]]


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]

2. In Sec.  319.56-34, paragraph (f) is amended as follows:
a. In the paragraph heading, by removing the words ``; rates of 
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]