[Federal Register Volume 78, Number 251 (Tuesday, December 31, 2013)]
[Unknown Section]
[Pages 79573-79579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-31189]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2011-0132]
RIN 0579-AD62


Importation of Fresh Apricots From Continental Spain

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

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SUMMARY: We are amending the fruits and vegetables regulations to allow 
the importation into the United States of fresh apricots from 
continental Spain (excluding the Balearic Islands and Canary Islands). 
As a condition of entry, fresh apricots from continental Spain will 
have to be produced in accordance with a systems approach that includes 
registration of production locations and packinghouses, pest 
monitoring, sanitary practices, chemical and biological controls, and 
phytosanitary treatment. The fruit will have to be imported in 
commercial consignments, with each consignment identified throughout 
its movement from place of production to port of entry in the United 
States. Consignments will have to be accompanied by a phytosanitary 
certificate issued by the national plant protection organization of 
Spain certifying that the fruit is free from all quarantine pests and 
has been produced in accordance with the systems approach. This action 
will allow for the importation of fresh apricots from continental Spain 
while continuing to protect against the introduction of plant pests 
into the United States.

DATES: Effective Date: January 30, 2014.

FOR FURTHER INFORMATION CONTACT: Ms. Meredith C. Jones, Senior 
Regulatory Policy Specialist, Regulatory Coordination and Compliance, 
PPQ, APHIS, 4700 River Road Unit 156, Riverdale, MD 20737-1231; (301) 
851-2018.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in ``Subpart-Fruits and Vegetables'' (7 CFR 319.56-
1 through 319.56-62, 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 
dissemination of plant pests within the United States.
    On January 30, 2013, we published in the Federal Register (78 FR 
6227-6232, Docket No. APHIS-2011-0132) a proposal \1\ to amend the 
regulations concerning the importation of fruits and vegetables to 
allow the importation of fresh apricots (Prunus armeniaca L.) \2\ from 
continental Spain (excluding the Balearic Islands and Canary Islands) 
into the United States. We proposed to allow the importation of fresh 
apricots from continental Spain only if they were produced in 
accordance with a systems approach jointly agreed upon in a bilateral 
workplan between the Animal and Plant Health Inspection Service (APHIS) 
and the national plant protection organization (NPPO) of Spain. The 
systems approach addresses four quarantine pests that the pest risk 
analysis (PRA) determined could follow the pathway of consignments of 
fresh apricots imported from continental Spain into the United States:
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    \1\ To view the proposed rule, supporting documents, and the 
comments we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0132.
    \2\ Although we included Prunus armeniaca Marshall as the 
scientific name for apricot in the proposed rule and risk 
assessment, both that name and Prunus armeniaca L. refer to the same 
species.
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     The Mediterranean fruit fly (Medfly), Ceratitis capitata 
Wiedemann,
     The plum fruit moth, Cydia funebrana (Treitschke),
     Leaf scorch, Apiognomonia erythrostoma (Pers.), a fungus, 
and
     Brown rot, Monilinia fructigena Honey, a fungus.
    The proposed systems approach included the following requirements: 
Registration of production locations and packinghouses; pest monitoring 
and control, including trapping for C. funebrana and C. capitata to 
demonstrate areas of low prevalence; grove sanitation; chemical 
controls; inspection by the NPPO of Spain for quarantine pests; and 
phytosanitary treatment in accordance with 7 CFR part 305 and the Plant 
Protection and Quarantine (PPQ) Treatment Manual.\3\ We also proposed 
that fruit would have to be imported in commercial consignments, with 
each consignment identified throughout its movement from place of 
production to port of entry in the United States, and that consignments 
would have to be

[[Page 79574]]

accompanied by a phytosanitary certificate issued by the NPPO of Spain 
stating that the fruit is free from all pests of quarantine concern and 
has been produced in accordance with the systems approach.
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    \3\ http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf.
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    We solicited comments concerning our proposal for 60 days ending 
April 1, 2013. We reopened and extended the deadline for comments until 
June 13, 2013, in a document published in the Federal Register on May 
29, 2013 (78 FR 32184, Docket No. APHIS-2011-0132). We received four 
comments by that date. They were from a foreign government, a State 
department of agriculture, an organization representing State plant 
regulatory agencies, and a university professor. They are discussed 
below by topic.

General Comments

    One commenter stated that we should not allow the import of 
apricots from Spain that have been sprayed with pesticides, unless 
methods can be devised to ensure that such fruit will not be toxic to 
consumers.
    The U. S. Environmental Protection Agency (EPA) is responsible for 
registering pesticides for use in the United States. EPA also has the 
responsibility to establish limits, or tolerances, for pesticide 
residues in both raw agricultural commodities and processed foods; 
these tolerances apply to both imported and domestically grown foods. 
EPA-established tolerances are commodity specific and represent the 
maximum amount of pesticide residue that may legally remain in food. In 
the absence of a tolerance, any level of pesticide residue is 
prohibited. The U. S. Food and Drug Administration is responsible for 
enforcing EPA pesticide residue tolerances and for determining whether 
an imported food violates the Federal Food, Drug, and Cosmetic Act.
    The proposed rule identifies the NPPO of Spain as the body 
responsible for conducting and supervising inspections, monitoring, 
trapping, surveying, and other activities required in the systems 
approach.
    A commenter acknowledged that the NPPO of Spain is responsible for 
these activities but noted that there are other bodies and stakeholders 
involved, such as the Spanish Autonomous Communities (the first-level 
political and administrative divisions in Spain), auditing companies, 
integrated pest management associations, and field technicians and 
advisors. Their roles are defined by Directive 2009/128/EC of the 
European Parliament and of the Council of 21 October 2009, which 
established a framework for European Union (EU) action to achieve the 
sustainable use of pesticides. The commenter stated that the 
responsibilities of each partner should be specified in future 
workplans under the proposed rules.
    In all APHIS fruit and vegetable importation programs, the NPPO 
certifies that it is taking responsibility to ensure that these other 
involved parties act under NPPO direction and perform the actions 
required by the regulations and workplan. Moreover, the NPPO is the 
official participant in the International Plant Protection Convention, 
which establishes the reciprocal obligations that trading countries 
have to each other. Whether the NPPO fulfills its duties through other 
parties whose roles are described in European Community (EC) directives 
or through other means is an internal matter not subject to our 
regulations. If the NPPO of Spain desires, workplans for the apricot 
program can include information about which entities will perform which 
required actions, but in the event of failure to perform any required 
action APHIS will hold only the NPPO responsible for correcting the 
problems. We note that the cited EC directive addresses only pesticide 
use and integrated pest management, rather than systems approaches for 
the growth and certification of crops for export, and even within that 
scope the directive emphasizes in many places the responsibility of 
competent authorities in the Member State to ensure required actions 
are taken.
    One commenter recommended that the bilateral workplan track closely 
with the pest mitigation measures specified by APHIS in the systems 
approach.
    That will be the case. The bilateral workplan is based on the 
regulations but specifies the pest mitigation measures of the systems 
approach in greater detail.
    We stated in the preamble to the proposed rule that, as a condition 
of entry, apricots from Spain would have to be produced in accordance 
with a limited harvest period and treated with surface disinfectant.
    One commenter noted that neither of these mitigation measures 
appears in the proposed regulatory language for the systems approach 
and asked that we remove these measures.
    The commenter is correct. These mitigation measures are not 
intended to be part of the systems approach and are not included in 
this final rule.

Monitoring and Oversight

    We proposed in Sec.  319.56-58(c) \4\ the requirement that the NPPO 
of Spain would have to visit and inspect places of production monthly, 
starting 2 months (60 days) before harvest and continuing until the end 
of the shipping season to verify that growers are complying with the 
proposed requirements.
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    \4\ The provisions of the systems approach will be added to the 
regulations as Sec.  319.56-63. In this final rule, we discuss the 
comments in terms of provisions of proposed Sec.  319.56-58 so that 
the reader can follow along with the proposal.
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    One commenter stated that, given the ripening period of apricot is 
approximately May 1 through July 15, official inspections would have to 
be conducted from March to August, which under the proposed regulations 
would require six inspections. The commenter stated that six 
inspections are unnecessary and not cost-effective and suggested 
instead that the NPPO visit production sites once at the beginning of 
the export season, once during harvest, and at any other times the NPPO 
finds necessary to verify compliance. The commenter stated that 
throughout harvest the NPPO, the Autonomous Communities, and the 
auditing companies employed by them would control, evaluate, and 
validate field notebooks maintained by growers and inspection reports 
from field technicians or advisors. The commenter added that the NPPO 
of Spain would ensure that APHIS requirements are being fulfilled by 
the involved parties.
    APHIS is making two changes in response to this comment. It is 
essential that the NPPO effectively monitor compliance before and 
during harvest to identify and prevent pest risks. However, effective 
inspection does not necessarily require six visits each year, and 
depending on the personnel authorized by the NPPO to conduct various 
compliance monitoring activities, it may not be necessary that NPPO 
employees visit each production site each month. While it is important 
that the production site be inspected prior to harvest, both to look 
for early signs of pests that may not be as visible later and to 
familiarize the inspector with the production area, upon further 
consideration we believe a reasonable standard is that a pre-harvest 
inspection occur at least 1 month prior to harvest rather than the 
proposed 2 months. Therefore, we are changing the proposed standard to 
read ``starting at least 1 month before harvest.'' We note also that 
the term ``before harvest'' refers to the harvest as conducted at each 
place of production, not to the harvest season in general, which in 
some cases could result in fewer inspections being necessary.
    As noted above, production site inspections are the responsibility 
of the NPPO and must be done under NPPO

[[Page 79575]]

direction to verify the conditions and actions required by the 
regulations and workplan. However, we acknowledge that the identity of 
the personnel authorized to conduct inspection-related activities may 
be determined by the NPPO and specified in the workplan, and that in 
some cases the NPPO may authorize other personnel, such as employees of 
an Autonomous Community or an auditing company, to perform duties 
related to inspection. If so, these personnel must be accountable to 
the NPPO. Therefore, in this final rule we are changing the relevant 
sentence in Sec.  319.56-58(c)(1) to read ``The NPPO of Spain, or an 
authorized person designated in the workplan, must visit and inspect. . 
. .''
    We proposed to require in Sec.  319.56-58(c)(1) that any personnel 
conducting trapping and pest surveys in accordance with the systems 
approach be hired, trained, and supervised by the NPPO of Spain.
    The same commenter noted that, while under EU regulations the NPPO 
of Spain is responsible for ensuring that such personnel are 
appropriately trained, such personnel are not necessarily hired or 
trained by the NPPO of Spain. The commenter asked that we delete the 
words ``hired'' and ``trained'' from this requirement.
    As we noted above, we understand that in some cases the NPPO may 
authorize other personnel not hired or trained by the NPPO, such as 
employees of an Autonomous Community or an auditing company, to perform 
duties related to inspection under the supervision of the NPPO. 
However, we agree that they do not necessarily have to be hired or 
trained by the NPPO. Therefore, we are deleting the words ``hired'' and 
``trained'' from the proposed requirement in Sec.  319.56-58(c)(1) and 
replacing those words with the term ``accredited'' to indicate they 
have been determined by the NPPO to be qualified to perform the 
assigned duties.
    Two commenters stated that procedures should be in place to confirm 
that approved treatments are applied properly to fresh apricot fruit 
imported from continental Spain.
    Under the bilateral workplan, APHIS will confirm that treatments of 
fresh apricot fruit are properly applied under supervision of the NPPO 
of Spain in accordance with the cold treatment regulations in Sec.  
305.6 and the PPQ Treatment Manual. Furthermore, under Sec.  319.56-
58(c)(4), the NPPO of Spain will be required to retain all forms and 
documentation related to export program activities, including approved 
treatments, in places of production and packinghouses for at least 1 
year and, upon request, provide them to APHIS for review.

Mitigations for A. erythrostoma

    One commenter noted that the PRA identifies the fungus A. 
erythrostoma as a pest that could follow the pathway of consignments of 
fresh apricots imported from Spain to the United States. The commenter 
stated, however, that scientific literature \5\ identifies A. 
erythrostoma as being only a pest of cherry in Spain, and consequently 
the mitigation measures we proposed for A. erythrostoma in fresh 
apricot are not supported by the literature.
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    \5\ P[eacute]rez JA, Garcia T, Arias A, Mart[iacute]nez de 
Velasco D. 1989. Lucha contra el hongo del cerezo Gnomonia 
erythrostoma (Pers.) Auersw. I. Eficacia de materias activas. 
Bolet[iacute]n Sanidad Vegetal y Plagas 4: 315-321. S[aacute]nchez 
OL, Garcia MT. 2007. Gnomonia. Apiognomonia erythrostoma. Fichas 
t[eacute]cnicas de Sanidad Vegetal. Ficha 10. Junta de Extremadura. 
Consejer[iacute]a de Agricultura y Desarrollo Rural. 
Direcci[oacute]n General de Explotaciones Agrarias. Santiago R. 
2008. Apiognomonia erythrostoma (Pers.) H[ouml]hnel. La ``Gnomonia'' 
del cerezo. Ficha 20. Laboratorio de Diagnostico del Servicio de 
Sanidad Vegetal. Junta de Extremadura.
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    We reviewed the documents cited by the commenter to support that A. 
erythrostoma does not occur on apricot in Spain. None of the documents 
rules out A. erythrostoma as being a potential pest risk to apricot in 
Spain, and one of the documents (Santiago, 2008) acknowledged that 
apricots are in fact a host of the pathogen. Moreover, A. erythrostoma 
has been reported as an apricot pest in Italy, Bulgaria, and Austria, 
and is listed as an apricot pest in the 2004 European and Mediterranean 
Plant Protection Organization standard ``Good Plant Protection 
Practices for Stone Fruits.''
    If a plant pest of quarantine concern is reported on a commodity in 
a particular country, APHIS considers it to be an import risk for all 
potential hosts of that pest in that country, unless there are 
mitigations in place to prevent its spread. No pest-free or low-
prevalence areas for A. erythrostoma have been established in Spain, 
leading to the risk that apricot production could be affected by the 
pathogen if the proposed mitigations are not applied. Therefore, we are 
making no changes with regards to the mitigations we proposed to 
require for A. erythrostoma.

Mitigations for C. funebrana

    We proposed to require in Sec.  319.56-58(f) that the NPPO of Spain 
use one of two mitigation options to address the risk potential posed 
by C. funebrana, the plum fruit moth, which we determined in the PRA to 
be one of the pests that could follow the pathway of apricot from 
Spain. Under the first mitigation option in Sec.  319.56-58(f)(1), 
apricots would have to originate from an area designated as free of C. 
funebrana in accordance with Sec.  319.56-5. Under the second option in 
Sec.  319.56-58(f)(2), apricots would have to originate from an area 
that has been demonstrated to have a low prevalence of C. funebrana. 
The NPPO of Spain would be required to visit and visually inspect 
registered places of production during the growing season and harvest 
period for signs of C. funebrana to demonstrate that the places of 
production have a low prevalence of C. funebrana and to verify that the 
growers are complying with the mitigation measures required as part of 
the systems approach.
    One commenter stated that, while the PRA identifies C. funebrana as 
a quarantine pest that could follow the pathway, its prevalence in 
apricots is much lower than that of the oriental fruit moth, C. 
molesta, and outbreaks of C. funebrana only take place occasionally in 
apricot orchards located near plum orchards. The commenter recommended 
that mitigation measures for C. funebrana such as pheromone trapping 
and monitoring should only be required for those apricot orchards 
located in the vicinity of plum orchards.
    We have no evidence to suggest that outbreaks of C. funebrana only 
occur in apricot orchards that are located near plum orchards. At any 
rate, it would not be practical to find every apricot orchard located 
near a plum orchard and determine specific boundaries within which 
mitigations for C. funebrana would be required.
    As part of the mitigations for establishing an area of low pest 
prevalence for C. funebrana, we proposed to require in Sec.  319.56-
58(f)(2) that the NPPO of Spain sample and visually inspect a quantity 
of fruit specified in the workplan. Specific inspection requirements 
would be included in the bilateral workplan and adjusted as necessary 
to ensure that inspection is effective. We would initially require 
samples of 20 fruits per tree from 50 trees within every 4 hectares to 
be visually inspected by the NPPO of Spain every 7 days during the 
growing season. During the harvest period, samples of 40 fruits per 
tree from 50 trees within every 4 hectares would have to be visually 
inspected by the NPPO of Spain every 7 days until harvest is completed. 
If more than 1 percent of the fruits sampled in a week are damaged or 
found to have any life stage of C. funebrana, remedial measures would 
have to be implemented.

[[Page 79576]]

    The same commenter opposed the requirement to increase the sampling 
size during the harvest period, stating that the symptoms of C. 
funebrana are more visible in the latter part of the growing season, 
thereby making infested fruit easier to detect. As support, the 
commenter cited APHIS pest response guidelines \6\ stating that C. 
funebrana larvae feed internally, resulting in internal symptoms only. 
Citing another study,\7\ the commenter added that infested fruits may 
ripen faster than uninfested fruits, allowing them to be readily 
detectable. The commenter concluded that the biology of C. funebrana 
does not support increasing the sample size during harvest period from 
1,000 to 2,000 fruits per 4 hectares each week and recommended that the 
sample size of 20 fruits per tree from 50 trees within every 4 hectares 
should remain invariable through the petal fall phase to the harvest 
period.
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    \6\ USDA, APHIS, PPQ. 2011. New Pest Response Guidelines: Plum 
Fruit Moth (Cydia funebrana. Washington, DC: http://www.aphis.usda.gov/import_export/plants/manuals/online_manuals.shtml.
    \7\ Vernon, JDR. 1971. Observations on the biology and control 
of the plum fruit moth. Plant Pathology 20(3): 106-110.
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    We are making no changes based on the comment. Contrary to the 
commenter's point, the APHIS pest response guidelines the commenter 
cited actually state that symptoms of infestation are readily visible 
on fruit early in the growing season. During the harvest season, the 
sample size must remain higher in order to minimize the risk of larvae 
being imported to the United States in infested fruit.
    The same commenter stated that we did not specify in the proposed 
regulatory text a minimum amount of sampled fruit in relation to the 
area of the place of production and suggested that in accordance with 
current standards of integrated production we amend Sec.  319.56-
58(f)(2) to set a minimum of 50 trees per place of production.
    The minimum amount of sampled fruit in relation to the area of the 
place of production will be worked out by APHIS in consultation with 
the NPPO of Spain. The sample amount will then be specified in the 
workplan required in Sec.  319.56-58(a)(1). Specifying the sample size 
in the workplan rather than in the regulations will give us the 
flexibility to change the size to meet changing conditions.
    Finally, the commenter stated that fruit is the primary sample unit 
and therefore the term ``growing season'' should be restricted to a 
more specific period such as ``fruit setting'' or ``after petal fall.''
    Our use of the term ``growing season'' is compatible with the 
specific period suggested by the commenter, i.e., from fruit set 
through the end of harvest season.

Mitigations for C. capitata

    We proposed to require in Sec.  319.56-58(g)(1) that trapping for 
C. capitata, a fruit fly, be conducted in the places of production to 
demonstrate that those places have a low prevalence of C. capitata. If 
the prevalence rises above levels specified in the bilateral workplan, 
remedial measures approved jointly by APHIS and the NPPO of Spain would 
have to be implemented. We also proposed to require in Sec.  319.56-
58(g)(2) that all apricots for export from continental Spain to the 
United States be treated for C. capitata in accordance with 7 CFR part 
305.
    Referring to the trapping requirements we proposed for C. capitata, 
one commenter stated that the threshold of 0.5 flies per trap per day 
would not allow growers to meet the technical guidelines of integrated 
production and would have a negative impact on the environmental 
sustainability of the growing region. The commenter stated that in 
accordance with current technical standards of integrated production 
used in the Autonomous Communities of Spain, 2 flies per trap per day 
is a more accurate intervention threshold for C. capitata.
    We are making no changes in response to the comment. C. capitata is 
a serious quarantine pest that is not present in the United States, but 
is endemic to Spain. Accordingly, we require a high level of protection 
against the introduction of C. capitata. The threshold of 0.5 flies per 
trap per day is appropriate given apricot's host status to C. capitata 
and is consistent with other import programs, such as the one for 
Spanish clementines.
    We stated in the proposed rule that two phytosanitary mitigation 
measures for C. capitata would be required because high larval 
populations in fruit can overwhelm the effectiveness of cold treatment. 
We noted that the trapping and field mitigation measures together would 
maintain populations of C. capitata at acceptably low prevalence levels 
and ensure that cold treatment is effective.
    One commenter asked to define what we mean by ``high larval 
populations.'' The commenter stated that such language does not provide 
additional information or quantitative scientifically supported data 
and that it would be necessary to state whether those populations are 
related to a percentage of fruit infestation.
    What APHIS determines to be high larval populations varies with the 
fruit in question and the prevalence of C. capitata in a particular 
area. Generally, high larval populations are those that pose a 
substantial risk of overwhelming pest mitigations that are in place. 
For example, in 2001 high populations of C. capitata larvae were 
detected in imported Spanish clementines that had undergone cold 
treatment, some of which were alive upon arrival in the United States.
    One commenter recommended that all treatments of fresh apricot 
fruit from continental Spain should be applied prior to importation 
into the United States.
    Pest mitigation measures, including treatments approved by APHIS 
and the NPPO of Spain, are applied to the fruit prior to its 
importation to the United States. The phytosanitary certificate issued 
by the NPPO of Spain will also have to confirm that each consignment of 
apricot fruit has undergone cold treatment for C. capitata.

Post-Harvest Procedures and Packinghouse Requirements

    In proposed Sec.  319.56-58(i), we included the requirement that, 
during the time the packinghouse is used to pack and export apricot 
fruit to the United States, the packinghouse must only accept fruit 
from places of production registered and approved by the NPPO of Spain. 
We proposed to require the packinghouse to pack no fruit for other 
markets during the time it packs apricots produced in accordance with 
the proposed rule's systems approach.
    One commenter suggested that we allow packinghouses to pack fruit 
for other markets during the same period, but under conditions that 
would prevent commingling of the fruit. The conditions they provided 
were (1) the packing lines in packinghouses be cleared prior to packing 
apricots for the United States, and (2) fruit destined for the United 
States must always be identified and stored separately from fruit 
destined for other markets. The commenter added that similar measures 
are already included in preclearance work plans for the export of sweet 
oranges, clementines, and other mandarins to the United States.
    After careful consideration, we have decided to change the rule in 
response to this comment, according to the following reasoning. 
Consider the following scenario for apricots produced in accordance 
with the proposed rule. There are two areas of pest risk

[[Page 79577]]

associated with the packinghouse. There is a small risk that C. 
capitata could enter the packinghouse associated with other articles 
destined for other markets, move to regulated apricots, and lay eggs in 
those apricots. However, this is unlikely because normal packinghouse 
operations make such movement of pests between lots exceedingly rare. 
There is a slightly larger risk that articles destined for other 
markets could become accidentally mixed with regulated apricots and 
shipped to the United States. Such mixing of articles could result in 
C. capitata larvae being shipped to the United States. We believe both 
of these areas of risk can be controlled using the methods suggested by 
the commenter. Maintaining the identity of regulated apricots at the 
packinghouse and ensuring separation between them and other articles 
are the key concerns. The proposed rule, in Sec.  319.56-58(a)(4), 
states that regulated apricots must ``remain identifiable when the 
fruit leaves the grove, at the packinghouse, and throughout the export 
process.''
    This identity requirement will aid achieving separation in the 
packinghouse. To fully achieve effective separation, we are changing 
the packinghouse requirement in Sec.  319.56-58(i) to read as follows: 
``During the time registered packinghouses are in use for packing 
apricots for export to the United States in accordance with the 
requirements of this section, packing lines must be cleared of all 
other articles and plant debris prior to packing such apricots, and 
such apricots must be stored in a room separate from any other fruits 
or plant articles while the apricots are at the packinghouse.''

Phytosanitary Inspection and Certificate

    Two commenters stated that risk mitigation measures should include 
an additional high level of inspection by APHIS at the U.S. port of 
entry.
    The risk mitigations we are adding to the regulations for the 
importation of fresh apricots from continental Spain include two points 
of inspection, one in continental Spain and one at the U.S. port of 
entry. Under Sec.  319.56-58(j)(1), a biometric sample of apricots, 
jointly agreed upon by APHIS and the NPPO of Spain, will be required to 
be inspected in Spain by the NPPO following post-harvest processing. 
The sample will have to be visually inspected for the quarantine pests 
A. erythrostoma, C. funebrana, and M. fructigena, and a portion of the 
fruit cut open to inspect for the internal pest C. capitata. If any of 
these quarantine pests are found, the entire consignment of apricots 
will be prohibited from import into the United States. In addition, 
each lot of apricot fruit from continental Spain will have to be 
presented for inspection at the U.S. port of entry with an accompanying 
shipping document indicating the place of production and the 
packinghouse in which the fruit was processed. Each consignment of 
apricot fruit will have to be accompanied by a phytosanitary 
certificate issued by the NPPO of Spain stating that the fruit has been 
treated for C. capitata in accordance with 7 CFR part 305 and includes 
an additional declaration stating that the fruit in the consignment was 
inspected and found free from A. erythrostoma, C. capitata, C. 
funebrana, and M. fructigena.
    One commenter stated that we should not suspend exports from the 
places of production if any C. capitata are detected in the required 
postharvest inspection of apricots in Spain. The commenter stated that 
a certain percentage of infestation should be accepted for apricots 
because they will be subjected to a cold treatment, which is the case 
in other operational workplans between Spain and the United States for 
the export of sweet oranges, clementines, and other mandarins. The 
commenter also stated that the phytosanitary certificate should not be 
required to state that the consignment is free of C. capitata.
    We are making no changes based on this comment. Given the serious 
threat C. capitata poses, we believe that it is reasonable to have no 
tolerance level for C. capitata infestation and to stop accepting 
shipments from a place of production pending investigation when a 
single larva is found during inspection. Furthermore, neither the 
operational workplan nor the regulations for importation of sweet 
oranges, clementines, and mandarins from Spain have such tolerances. We 
note that the relevant requirement in our regulations for the 
importation of clementines from Spain, Sec.  319.56-34(f), states that 
``If inspectors find a single live Mediterranean fruit fly in any stage 
of development during an inspection, the entire consignment of 
clementines will be rejected. If a live Mediterranean fruit fly in any 
stage of development is found in any two lots of fruit from the same 
orchard during the same shipping season, that orchard will be removed 
from the export program for the remainder of that shipping season.''
    The same commenter suggested a biometric sample size of 200 fruits 
for the post-harvest inspection of C. capitata. The commenter 
calculated that sample size using the standard in the International 
Standards For Phytosanitary Measures No. 31, ``Methodologies for 
sampling of consignments'' (International Plant Protection Convention, 
2009).\8\ The commenter stated that calculating the sample size for a 
95 percent confidence level at a 2 percent level of detection, 
according to a 75 percent efficacy value where the lot size is large 
and sufficiently mixed, yields 199 or 200 fruits by the binomial or 
Poisson distribution, respectively.
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    \8\ https://www.ippc.int/file_uploaded/1229532867492_ISPM31_2008_E.pdf.
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    We do not disagree with the commenter's methodology, but as we 
stated in the proposed rule, the actual sampling rate will be worked 
out by technical experts in APHIS in consultation with the NPPO of 
Spain. The sample size will then be specified in the workplan required 
in Sec.  319.56-58(a)(1). Specifying the sample size in the workplan 
rather than in the regulations will give us the flexibility to raise or 
lower the fruit sampling rate when conditions indicate a higher or 
lower risk of C. capitata infestation.
    Therefore, for the reasons given in the proposed rule and in this 
document, we are adopting the proposed rule as a final rule, with the 
changes discussed in this document.

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 
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).
    This rule will amend the regulations to allow the importation into 
the United States of fresh apricots from continental Spain, subject to 
a systems approach.
    The economic analysis examines impacts for U.S. small entities of a 
rule that would allow fresh apricot imports from continental Spain. 
Spain is expected to export at most 10 standard shipping containers of 
fresh apricot per year to the United States. Each container can hold 
approximately 18 metric tons (MT), thus fresh apricot imports from 
Spain may total as much as 180 MT annually. This amount is equivalent 
to about 1 percent of current U.S. consumption. With U.S. fresh apricot 
exports four times the quantity

[[Page 79578]]

imported, and the amount expected to be imported from Spain very small 
in comparison to current U.S. consumption, any market effects of such a 
relatively small change in supply would be minor.
    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 allows fresh apricots to be imported into the 
United States from continental Spain. State and local laws and 
regulations regarding fresh apricots imported under this rule will be 
preempted while the fruit is in foreign commerce. Fresh fruits are 
generally imported for immediate distribution and sale to the consuming 
public, and 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. 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 final rule, which were 
filed under 0579-0402, have been submitted for approval to the Office 
of Management and Budget (OMB). When OMB notifies us of its decision, 
if approval is denied, we will publish a document in the Federal 
Register providing notice of what action we plan to take.

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 rule, please contact Mrs. Celeste Sickles, 
APHIS' Information Collection Coordinator, at (301) 851-2908.

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:

PART 319-FOREIGN QUARANTINE NOTICES

0
1. The authority citation for part 319 continues to read as follows:

    Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 
and 136a; 7 CFR 2.22, 2.80, and 371.3.


0
2. A new Sec.  319.56-63 is added to read as follows:


Sec.  319.56-63  Fresh apricots from continental Spain.

    Fresh apricots (Prunus armeniaca L.) may be imported into the 
United States from continental Spain (excluding the Balearic Islands 
and Canary Islands) only under the conditions described in this 
section. These conditions are designed to prevent the introduction of 
the following quarantine pests: Apiognomonia erythrostoma (Pers.), a 
brown rot fungus; Ceratitis capitata Wiedemann, the Mediterranean fruit 
fly; Cydia funebrana (Treitschke), the plum fruit moth; and Monilinia 
fructigena Honey, the leaf scorch fungus.
    (a) General requirements. (1) The national plant protection 
organization (NPPO) of Spain must provide a bilateral workplan to APHIS 
that details the activities that the NPPO of Spain will, subject to 
APHIS' approval of the workplan, carry out to meet the requirements of 
this section. APHIS will be directly involved with the NPPO of Spain in 
monitoring and auditing implementation of the systems approach. The 
NPPO of Spain must also enter into a trust fund agreement with APHIS in 
accordance with Sec.  319.56-6.
    (2) All places of production and packinghouses that participate in 
the export program must be registered with the NPPO of Spain.
    (3) The fruit must be grown at places of production that meet the 
requirements of this section.
    (4) The fruit must be packed for export to the United States in a 
packinghouse that meets the requirements of paragraph (i) of this 
section. The place of production where the apricots were grown must 
remain identifiable when the fruit leaves the grove, at the 
packinghouse, and throughout the export process. Safeguarding in 
accordance with paragraph (h) of this section must be maintained at all 
times during the movement of the apricot fruit to the United States and 
must be intact upon arrival of the apricot fruit in the United States.
    (b) Commercial consignments. Apricots from continental Spain may be 
imported to the United States in commercial consignments only.
    (c) Monitoring and oversight. (1) The NPPO of Spain, or an 
authorized person designated in the workplan, must visit and inspect 
places of production starting at least 1 month (30 days) before harvest 
and continuing until the end of the shipping season to verify that 
growers are complying with the requirements of this section and to 
follow pest control guidelines, when necessary, to reduce quarantine 
pest populations. The NPPO of Spain must certify that exporting places 
of production have fruit fly and moth trapping programs and follow 
control guidelines, when necessary, to reduce regulated pest 
populations. Any personnel conducting trapping and pest surveys must be 
accredited and supervised by the NPPO of Spain. APHIS may monitor the 
places of production if necessary.
    (2) In addition to conducting fruit inspections at the 
packinghouses, the NPPO of Spain must monitor packinghouse operations 
to verify that the packinghouses are complying with the requirements of 
this section.
    (3) If the NPPO of Spain finds that a place of production or 
packinghouse is not complying with the requirements of this section, no 
fruit from the place of production or packinghouse will be eligible for 
export to the United States until APHIS and the NPPO of Spain conduct 
an investigation and implement appropriate remedial actions.
    (4) The NPPO of Spain must retain all forms and documents related 
to export program activities in places of production and packinghouses 
for at least 1 year and, as requested, provide them to APHIS for 
review.
    (d) Grove sanitation. Fruit that has fallen from the trees at each 
place of production must be removed and destroyed weekly.
    (e) Fungi. During the growing season, the NPPO of Spain must 
conduct inspections at intervals specified in the workplan in the place 
of production for signs of A. erythrostoma and M. fructigena until 
harvest is completed. Infected leaves must be removed from places of 
production to reduce the inoculum potential. Upon detection of these 
fungal diseases, the NPPO of Spain must notify APHIS, which may 
prohibit the importation into the United States of apricots from the 
production site for the season.
    (f) C. funebrana. The NPPO of Spain must use one of the following 
two mitigation measures to address the risk potential posed by C. 
funebrana.
    (1) Pest-free area. Under this mitigation measure, apricots must

[[Page 79579]]

originate from an area designated as free of C. funebrana in accordance 
with Sec.  319.56-5.
    (2) Area of low pest prevalence and pest management. Under this 
mitigation measure, the NPPO of Spain must visit and visually inspect 
registered places of production during the growing season and harvest 
period for signs of C. funebrana to demonstrate that the places of 
production have a low prevalence of C. funebrana and to verify that the 
growers are complying with the requirements of this paragraph. The NPPO 
of Spain must also sample and visually inspect a quantity of fruit 
specified in the workplan. Trapping must also be conducted in the 
places of production to demonstrate that the places of production have 
a low prevalence of C. funebrana. If the prevalence of any life stage 
of C. funebrana rises above levels specified in the bilateral workplan, 
remedial measures approved jointly by APHIS and the NPPO of Spain must 
be implemented. The NPPO of Spain must keep records of the placement of 
traps, trap visits, trap counts, and treatments for each registered 
place of production and make the records available to APHIS upon 
request.
    (g) C. capitata. (1) Trapping must be conducted in the places of 
production to demonstrate that those places of production have a low 
prevalence of C. capitata. Specific trapping requirements are included 
in the bilateral workplan. If the prevalence rises above levels 
specified in the bilateral workplan, remedial measures approved jointly 
by APHIS and the NPPO of Spain must be implemented. The NPPO of Spain 
must keep records of the placement of traps, trap visits, trap counts, 
and treatments for each registered place of production and make the 
records available to APHIS upon request.
    (2) All apricots for export from continental Spain to the United 
States must be treated for C. capitata in accordance with part 305 of 
this chapter.
    (h) Post-harvest procedures. The apricots must be safeguarded by a 
pest-proof screen, plastic tarpaulin, or by some other pest-proof 
barrier while in transit to the packinghouse and while awaiting 
packing. They must be packed within 24 hours of harvest into pest-proof 
cartons or containers or covered with pest-proof mesh or a plastic 
tarpaulin for transport to the United States. These safeguards must 
remain intact until arrival of the consignment in the United States.
    (i) Packinghouse requirements. Packing of apricots for export to 
the United States must be conducted within a packinghouse registered 
and approved by the NPPO of Spain. Packinghouses in which apricots are 
packed for export to the United States must be able to exclude 
quarantine pests. All openings to the outside of the packinghouse must 
be covered by screening with openings of not more than 1.6 mm or by 
some other barrier that prevents pests from entering. The packinghouse 
must have double self-closing doors at the entrance to the facility and 
at the interior entrance to the area where the apricots are to be 
packed. During the time registered packinghouses are in use for packing 
apricots for export to the United States in accordance with the 
requirements of this section, packing lines must be cleared of all 
other articles and plant debris prior to packing such apricots, and 
such apricots must be stored in a room separate from any other fruits 
or plant articles while the apricots are at the packinghouse.
    (j) Phytosanitary inspection. (1) A biometric sample of apricot 
fruit jointly agreed upon by APHIS and the NPPO of Spain must be 
inspected in Spain by the NPPO of Spain following post-harvest 
processing. The sample must be visually inspected for the quarantine 
pests A. erythrostoma, C. funebrana, and M. fructigena. A portion of 
the fruit must be cut open and inspected for C. capitata. If any of 
these quarantine pests are found, the entire consignment of apricot 
fruit will be prohibited from importation into the United States.
    (2) Fruit presented for inspection at a U.S. port of entry must be 
identified in the shipping documents accompanying each lot of fruit 
that specify the place of production in which the fruit was produced 
and the packinghouse in which the fruit was processed. This 
identification must be maintained until the fruit is released for entry 
into the United States.
    (k) Phytosanitary certificate. Each consignment of apricot fruit 
must be accompanied by a phytosanitary certificate issued by the NPPO 
of Spain that states that the fruit has been treated for C. capitata in 
accordance with 7 CFR part 305 and includes an additional declaration 
that the fruit in the consignment was inspected and found free from A. 
erythrostoma, C. capitata, C. funebrana, and M. fructigena.

(Approved by the Office of Management and Budget under control 
number 0579-0402)

    Done in Washington, DC, this 23rd day of December 2013.
 Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2013-31189 Filed 12-30-13; 8:45 am]
BILLING CODE 3410-34-P