[Federal Register Volume 81, Number 12 (Wednesday, January 20, 2016)]
[Proposed Rules]
[Pages 3033-3038]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00992]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 81, No. 12 / Wednesday, January 20, 2016 / 
Proposed Rules  

[[Page 3033]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2015-0073]
RIN 0579-AE18


Importation of Fresh Apple and Pear Fruit Into the Continental 
United States From Certain Countries in the European Union

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Proposed rule.

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SUMMARY: We are proposing to amend the regulations to allow the 
importation of fresh apple and pear fruit from certain countries in the 
European Union into the continental United States, provided that the 
fruit is produced in accordance with a systems approach, as an 
alternative to importation under the current preclearance program. The 
proposed systems approach for fresh apple and pear fruit consists of 
production site and packinghouse registration, inspection of registered 
production sites twice a season, production site pest control and 
sanitation, post-harvest safeguards, fruit culling, traceback, 
sampling, cold treatment against Mediterranean fruit fly in countries 
where the pest is known to occur, a phytosanitary certificate, port of 
entry inspection, and importation as commercial consignments only. 
Fresh apple and pear fruit that does not meet the requirements in the 
systems approach would continue to be allowed to be imported into the 
United States subject to the conditions of the preclearance program. 
This action would provide an alternative for the importation of fresh 
apple and pear fruit from certain countries in the European Union while 
continuing to provide protection against the introduction of plant 
pests into the continental United States.

DATES: We will consider all comments that we receive on or before March 
21, 2016.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2015-0073.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2015-0073, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents and any comments we receive on this docket may 
be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2015-
0073 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. David B. Lamb, Senior Regulatory 
Policy Specialist, USDA/APHIS/PPQ, 4700 River Road Unit 133, Riverdale, 
MD 20737-1236; (301) 851-2103; [email protected].

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 or the 
fruits and vegetables regulations), the Animal and Plant Health 
Inspection Service (APHIS) of the United States Department of 
Agriculture (USDA) 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.
    Currently, Sec.  319.56-22 provides conditions for importation of 
fresh apple fruit (Malus domestica Borkh.) from Belgium, Denmark, 
France, Germany, Great Britain, Italy, the Netherlands, Northern 
Ireland, Norway, Portugal, the Republic of Ireland, Spain, Sweden, and 
Switzerland, and fresh pear fruit (Pyrus communis L.) from Belgium, 
France, Great Britain, Italy, the Netherlands, Portugal, and Spain, 
into the United States under a preclearance program. Conditions for 
importation of fresh apple and pear fruit from the above countries 
include a trust fund agreement between the national plant protection 
organization (NPPO) of the exporting country and APHIS; orchard and 
packinghouse inspections for Leucoptera malifoliella and other 
quarantine plant pests; approved mitigations for infested orchards; 
cold treatment of fruit against Mediterranean fruit fly (Ceratitis 
capitata, or Medfly) in countries where the pest is known to occur; 
identification of orchards and packinghouses for traceback of each 
consignment; packinghouse handling and safeguarding requirements for 
fruit intended for shipment to the United States; and preclearance 
inspection.
    As an alternative to the preclearance program, the European 
Commission, the executive body of the European Union (EU), has 
requested that APHIS amend the regulations to allow the importation 
into the continental United States from certain EU countries of fresh 
apple and pear fruit that has been produced in accordance with an 
approved systems approach. Any alternative approach to the preclearance 
program for importing these articles requires that the current 
regulations be amended.
    As part of our evaluation of the EU's request, we prepared a pest 
list \1\ of quarantine pests that could follow the pathway of 
commercial shipments of fresh apple and pear fruit into the continental 
United States from the EU member countries included in the request. 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.'' The pest list reported 32 quarantine pests (26 
arthropods, 1 bacterium, 4 fungi and 1 viroid) that may follow the 
pathway of commercial shipments of apples and pears into the 
continental United States. They are:
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    \1\ ``Pest List for Importation of Fresh Fruit of Apple, Malus 
domestica, and Pear, Pyrus communis, into the Continental United 
States from eight countries in the European Union (Belgium, Germany, 
France, Italy, Poland, Portugal, Spain, the Netherlands)'' (USDA, 
2014).

    Arthropods:
Adoxophyes orana (Fischer von R[ouml]eslerstamm) (Lepidoptera: 
Tortricidae)
Aphanostigma piri (Cholodkovsky) (Hemiptera: Phylloxeridae)

[[Page 3034]]

Archips podana (Scopoli) (Lepidoptera: Tortricidae)
Argyrotaenia pulchellana (Haworth) (Lepidoptera: Tortricidae)
Ceratitis capitata (Wiedemann) (Diptera: Tephritidae)
Ceroplastes japonicus Green (Hemiptera: Coccidae)
Choristoneura hebenstreitella (Muller) (Lepidoptera: Tortricidae)
Cryptoblabes gnidiella (Milliere) (Lepidoptera: Pyralidae)
Cydia pyrivora (Danilevsky) (Lepidoptera: Tortricidae)
Diloba caeruleocephala (L.) (Lepidoptera: Noctuidae)
Eutetranychus orientalis (Klein) (Acari: Tetranychidae)
Euzophera bigella (Zeller) (Lepidoptera: Pyralidae)
Grapholita funebrana Treitschke (Lepidoptera: Tortricidae)
Grapholita lobarzewskii (Nowicki) (Lepidoptera: Tortricidae)
Hedya pruniana (Hubner) (Lepidoptera: Tortricidae)
Lacanobia oleracea L. (Lepidoptera: Noctuidae)
Leucoptera malifoliella (Costa) (Lepidoptera: Lyonetiidae)
Lobesia botrana Dennis & Schiffermuller (Lepidoptera: Tortricidae)
Mamestra brassicae L. (Lepidoptera: Noctuidae)
Pammene rhediella (Clerck) (Lepidoptera: Tortricidae)
Pandemis cerasana (Hubner) (Lepidoptera: Tortricidae)
Pandemis heparana (Denis & Schiffermuller) (Lepidoptera: 
Tortricidae)
Rhynchites aequatus (L.) (Coleoptera: Curculionidae)
Rhynchites auratus (Scopoli) (Coleoptera: Curculionidae)
Rhynchites bacchus (L.) (Coleoptera: Curculionidae)
Syndemis musculana (Hubner) (Lepidoptera: Tortricidae)
    Bacteria:
Erwinia pyrifoliae Kim et al.
    Fungi:
Alternaria gaisen Nagano (Ascomycetes: Pleosporales)
Ascochyta pyricola Sacc. (Ascomycetes: Pleosporales)
Monilinia fructigena Honey ex Whetzel (Ascomycetes: Helotiales)
Monilinia polystroma (G.C.M. Leeuwen) Kohn (Ascomycetes: Helotiales)
    Viroid:
Pear blister canker viroid (PBCVd) \2\
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    \2\ Apples and pears infected with the plant pathogenic pear 
blister canker viroid (PBCVd) are not a pathway. The pathogen is not 
insect or seed transmitted, and cannot be transmitted from the 
vascular tissue of fruit (Hadidi et al., 2011). This systemic 
pathogen could be present in the fruit, but it will not establish in 
the United States because the pathogen is neither seed transmitted 
nor insect vectored (Flores et al., 2003). Since there is no 
evidence that apples or pears are pathways for PBCVd (USDA, 2014) we 
would not require any mitigation measures for the disease.

    We prepared a risk management document (RMD) to determine what 
phytosanitary measures should be applied to mitigate the pest risk 
associated with the importation of fresh apple and pear fruit from 
certain EU member countries into the continental United States. Copies 
of the pest list and RMD may be obtained from the person listed under 
FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web 
site (see ADDRESSES above for a link to Regulations.gov and information 
on the location and hours of the reading room).
    In the RMD, entitled, ``Importation of Fresh Fruit of Apple, Malus 
domestica, and Pear, Pyrus communis, into the Continental United States 
from eight countries in the European Union (Belgium, Germany, France, 
Italy, Poland, Portugal, Spain, the Netherlands),'' (July 2015), we 
determined that phytosanitary measures could be applied as a systems 
approach to mitigate the risks of introducing or disseminating the 
quarantine pests in the pest list into the continental United States. 
Therefore, we are proposing to allow the importation of fresh apple and 
pear fruit from the EU countries of Belgium, Germany, France, Italy, 
Poland, Portugal, Spain, and the Netherlands into the continental 
United States if the fruit is produced under the systems approach 
described below. Fresh apple and pear fruit that does not meet the 
conditions of the systems approach would still be allowed to be 
imported into the continental United States if it is produced in 
accordance with the requirements of Sec.  319.56-22. Fruit imported 
under Sec.  319.56-22 would still be required to be in commercial 
consignments and accompanied by documentation to validate foreign site 
preclearance inspection after the required treatment is completed.
    We have determined that the specific mitigation measures proposed 
for the quarantine pests identified in the pest list, along with the 
general requirements for the importation of fruits and vegetables in 
the regulations, will be sufficient to prevent the introduction of 
quarantine pests into the continental United States via importation of 
fresh apple and pear fruit from the EU countries listed above. 
Therefore, we are proposing to add the systems approach to the 
regulations in a new Sec.  319.56-75.

General Requirements

    Paragraph (a) of proposed Sec.  319.56-75 would set out general 
requirements for the NPPO of the exporting country and for growers and 
packers producing fresh apple and pear fruit for export to the 
continental United States.
    Paragraph (a)(1) of proposed Sec.  319.56-75 would require the NPPO 
of the exporting country to develop an operational workplan, subject to 
APHIS approval, that details the activities that the NPPO would carry 
out to meet the requirements of proposed Sec.  319.56-75. An 
operational workplan is an agreement developed between APHIS' Plant 
Protection and Quarantine program, officials of the NPPO of a foreign 
government, and, when necessary, foreign commercial entities, that 
specifies in detail the phytosanitary measures that will be carried out 
to comply with our regulations governing the importation of a specific 
commodity. Operational workplans apply only to the signatory parties 
and establish detailed procedures and guidance for the day-to-day 
operations of specific import/export programs. Operational workplans 
also establish how specific phytosanitary issues are dealt with in the 
exporting country and make clear who is responsible for dealing with 
those issues. The implementation of a systems approach typically 
requires an operational workplan to be developed. The operational 
workplan may include, but is not limited to, details of the orchard 
monitoring, pest action thresholds, orchard phytosanitary measures 
including removing fallen fruit, packinghouse inspection procedures, 
and traceback requirements.
    Paragraph (a)(2) of proposed Sec.  319.56-75 would state that only 
commercial consignments of fresh apple and pear fruit from certain EU 
countries would be allowed to be imported into the continental United 
States. Commercial consignments, as defined in Sec.  319.56-2, are 
consignments that an inspector identifies as having been imported for 
sale and distribution. Such identification is based on a variety of 
indicators, including, but not limited to: Quantity of produce, type of 
packaging, identification of grower or packinghouse on the packaging, 
and documents consigning the fruits or vegetables to a wholesaler or 
retailer. Commercial consignments are less likely to be infested with 
plant pests than noncommercial consignments. Noncommercial consignments 
are more prone to infestations because the commodity is often ripe to 
overripe, may be of a variety with unknown susceptibility to pests, and 
is often grown with little or no pest control.

Production Site Requirements

    Under proposed Sec.  319.56-75(b)(1), production sites where fresh 
apple or pear fruit is grown would be required to be registered with 
the NPPO of the exporting country. Such registration would facilitate 
traceback of a

[[Page 3035]]

consignment of fresh apple or pear fruit to the production site in the 
event that quarantine pests were discovered in the consignment at the 
port of first arrival into the continental United States. APHIS would 
reserve the right to conduct oversight visits at the production site in 
the event of pest interceptions or other problems.
    Under proposed paragraph (b)(2), the registered grower of the 
production site would be responsible for following the phytosanitary 
measures agreed upon by APHIS and the NPPO of the exporting country, 
including removal of fallen fruit and other control measures that are 
authorized for use in the EU and the United States to reduce pest 
populations. The NPPO of the exporting country or officials authorized 
by the NPPO would be responsible for monitoring pest populations at 
production sites in order to determine the need and timing of such 
control measures and ensure effective control of pests. The NPPO would 
also be required to ensure that registered production sites are 
inspected twice every season, with special emphasis on quarantine pests 
listed in the operational workplan.
    Details of production site traceback and pest monitoring 
requirements, pest action thresholds, field sanitation, and other 
phytosanitary measures would be included in the operational workplan 
approved by the NPPO of the exporting country and APHIS.
    Paragraph 319.56-75(b)(3) would require that apple and pear 
propagative material introduced into registered production sites be 
certified free of quarantine pests by the NPPO of the exporting 
country.

Packinghouse Requirements

    Paragraph (c) of proposed Sec.  319.56-75 would set forth 
requirements for pest mitigation, fruit sampling, inspection, and other 
measures that would have to take place at registered packinghouses 
under the operational workplan.
    Under proposed Sec.  319.75(c)(1), all fresh apple and pear fruit 
for export to the United States would be required to be packed in 
packinghouses that are registered and approved by the NPPO of the 
exporting country. Packinghouses would have to be able to exclude plant 
pests and have a tracking system to identify individual production 
sites. Requirements for packinghouse specifications and procedures 
would be detailed in the operational workplan.
    Under proposed Sec.  319.75(c)(2), packinghouses would not be 
permitted to pack apple or pear fruit for other countries while packing 
for the continental United States. All leaves would have to be removed 
from fruit to remove the leaf mining pest Leucoptera malifoliella. 
Packinghouse culling and inspection procedures would have to be 
followed to remove fruit with pupae of Leucoptera malifoliella. These 
procedures would be detailed in the operational workplan.
    Under paragraph (c)(3), all packed fruit intended for shipment to 
the United States would need to be safeguarded from infestation by 
fruit flies and other pests at the packinghouse and during transport to 
the continental United States. Safeguarding measures for packinghouses 
and packed fruit, which would be detailed in the operational workplan, 
include protecting fruit by a pest-proof screen or plastic tarpaulin 
while the fruit is in transit to the packinghouse and while awaiting 
packing. Other safeguarding measures include the use of packinghouse 
screens and double doors that are sufficient to prevent pests from 
entering the packing area and requiring fruit to be packed in insect-
proof cartons or containers, or covered with insect-proof mesh or a 
plastic tarpaulin, for transport to the United States.
    Under proposed paragraph (c)(4), apple and pear fruit would have to 
be held in a cold storage facility while awaiting export. If any other 
fruit from unregistered production sites are stored in the same 
facility, the apple and pear fruit must be isolated from that other 
fruit.
    Under proposed Sec.  319.75(c)(5), each shipping box would need to 
be marked with the identity of the packing facility, the production 
site, and grower or grower organization to enable trace back as 
necessary.

Mitigations for Medfly

    Under proposed Sec.  319.56-75(d), apple and pear fruit being 
exported from countries where APHIS has determined that Medfly is known 
to occur would be required to undergo cold treatment in accordance with 
the phytosanitary treatments regulations in 7 CFR part 305. Currently, 
treatment schedule T 107-a \3\ is approved for apples and pears from 
countries where Medfly is known to occur. Details of required cold 
treatment procedures would be included in the operational workplan.
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    \3\ USDA/PPQ Treatment Manual, section 5, Treatment Schedules. 
https://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf.
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Phytosanitary Inspection

    Paragraph Sec.  319.56-75(e) would require that, after post-harvest 
processing, the NPPO of the exporting country or officials authorized 
by the NPPO of the exporting country inspect the apple and pear fruit 
for signs of pest infestation and confirm absence of the pests listed 
in the operational workplan. Upon detection of Adoxophyes orana, 
Alternaria gaisen, Argyrotaenia pulchellana, Ascochyta piricola, 
Ceratitis capitata, Grapholita (Cydia) funebrana, Leucoptera 
malifoliella, Monilinia fructigena and/or Monilinia polystroma in a 
consignment for export, the NPPO of the exporting country would be 
required to reject that consignment and may, under conditions specified 
in the operational workplan, be required to suspend the production site 
and/or packinghouse from importation to the continental United States 
for the remainder of that season. If any of these pests are found in a 
consignment at U.S. ports of entry, APHIS may, under conditions 
specified in the operational workplan, reject the consignment and 
suspend imports from the production site and/or packinghouse until an 
investigation is completed by the NPPO of the exporting country and 
APHIS. The investigation may include site visits by APHIS and reports 
from the NPPO of the exporting country. Procedures for suspension of 
production sites and/or packinghouses would be detailed in the 
operational workplan. The exportation to the continental United States 
of fresh apple and pear fruit from a suspended production site and/or 
packinghouse may resume in the next growing season if an investigation 
is conducted and APHIS and the NPPO of the exporting country agree that 
appropriate remedial actions have been taken.

Phytosanitary Certificate

    Paragraph Sec.  319.56-75 (f) would require that each consignment 
of fresh apple or pear fruit be accompanied by a phytosanitary 
certificate issued by the NPPO of the exporting country. Requiring a 
phytosanitary certificate ensures that the NPPO of the exporting 
country has inspected the fruit and certified that the fruit meets the 
conditions under the systems approach for export to the continental 
United States.
    APHIS has determined that the above risk management measures under 
the proposed systems approach will mitigate the risk of pest 
introductions on fresh apple and pear fruit from Belgium, Germany, 
France, Italy, Poland, Portugal, Spain, and the Netherlands into the 
continental United States.

Executive Order 12866 and Regulatory Flexibility Act

    This proposed rule has been reviewed under Executive Order 12866. 
The

[[Page 3036]]

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 5 U.S.C. 603, we have performed an initial 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this proposed rule on small entities. 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).
    Based on the information we have, there is no reason to conclude 
that adoption of this proposed rule would result in any significant 
economic effect on a substantial number of small entities. However, we 
do not currently have all of the data necessary for a comprehensive 
analysis of the effects of this proposed rule on small entities. 
Therefore, we are inviting comments on potential effects. In 
particular, we are interested in determining the number and kind of 
small entities that may incur benefits or costs from the implementation 
of this proposed rule.
    This proposed rule would allow the importation of fresh apples 
(Malus domestica) and fresh pears (Pyrus communis) from eight European 
Union (EU) countries (Belgium, France, Germany, Italy, the Netherlands, 
Poland, Portugal, and Spain, referred to here as the EU-8) into the 
continental United States, if they are produced in accordance with an 
approved systems approach. At present, importation of fresh pear from 
Germany and fresh apple and fresh pear from Poland is not allowed. For 
the other EU-8 countries, this action would provide an alternative to 
current preclearance import requirements.
    The United States and the EU both have large apple and pear 
industries. U.S. demand for EU-8 apples and pears imported under the 
proposed rule would depend on relative prices and on market 
characteristics as determined by domestic and foreign supplies and 
consumer preferences. The competitiveness of EU-8 apples and pears 
would largely rest on their prices, the varieties shipped, and their 
quality.
    The EU estimates that annual apple and pear exports by the EU-8 to 
the United States would total 14,000 MT under the proposed rule. EU-8 
apple and pear exports in recent years to countries outside of the EU 
show the quantity of apples to have been four times that of pears. For 
our analysis, we apportion the 14,000 MT similarly, that is, 80 percent 
apple (11,200 MT) and 20 percent pear (2,800 MT).
    Apple and pear imports from the EU-8 would directly compete with 
U.S. produced fruit since the growing seasons are the same. Most apple 
and pear imports by the United States come from southern hemisphere 
countries (89 percent of apple imports, 78 percent of pear imports) 
and, notwithstanding year-round storage capabilities, we expect any 
displacement of apple and pear imports from current sources by EU-8 
shipments would be limited due to different growing seasons. For this 
analysis, we therefore assume that not more than 10 percent of U.S. 
apple and pear imports from the EU-8 countries would displace imports 
from elsewhere.
    We use a non-spatial, net trade, partial equilibrium approach to 
welfare analysis to compute expected impacts of the proposed rule on 
U.S. producers and consumers. We model changes in U.S. consumption, 
production, price, consumer welfare, and producer welfare for three 
import levels (the expected quantity, and this quantity plus or minus 
10 percent). In all cases, consumer welfare gains under the proposed 
rule outweigh producer welfare losses, yielding a positive net welfare 
impact. The expected net benefit for the two fruits exceeds $1.3 
million per year.
    For apples, producer welfare losses under the three import levels 
range between $9.2 million and $11.2 million, the equivalent of about 
0.3 percent of the annual value of fresh apple production. Consumer 
welfare gains range between $10.0 million and $12.2 million, yielding 
net welfare gains of between $800,000 and $1 million. Apple prices are 
calculated to decline by about 0.5 percent when 11,200 MT of fresh 
apples are imported annually from the EU-8. This quantity is equivalent 
to about 0.5 percent of annual fresh apple consumption in the United 
States.
    For pears, producer welfare losses under the three import levels 
range between $1.9 million and $2.3 million, coincidentally also 
equivalent to about 0.3 percent of the annual value of fresh pear 
production. Consumer welfare gains range between $2.3 million and $2.8 
million, and net welfare gains are less than $500,000. Pear prices are 
calculated to decline by about 0.4 percent when 2,800 MT of fresh pears 
are imported annually from the EU-8. This quantity is equivalent to 
about 0.7 percent of annual fresh pear consumption in the United 
States. Small-entity apple and pear producers may be directly affected 
by the proposed rule. Other small entities that may be affected include 
those in auxiliary industries that support the production and 
distribution of fresh apples and pears in the United States, as well as 
importers of fresh apples and pears.

Executive Order 12988

    This proposed rule would allow fresh apple and pear fruit to be 
imported into the continental United States from certain EU countries 
under a systems approach. If this proposed rule is adopted, State and 
local laws and regulations regarding fresh apple and pear 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-
2015-0073. 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. A comment to 
OMB is best assured of having its full effect if OMB receives it within 
30 days of publication of this proposed rule.
    The regulations in ``Subpart--Fruits and Vegetables'' (Title 7, 
Code of Federal Regulations (CFR) 319.56 through 319.56-74, referred to 
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 that are new 
to or not widely distributed with the United States.
    APHIS is proposing to amend the regulations to allow the 
importation of fresh apple and pear fruit from certain

[[Page 3037]]

countries in the European Union into the continental United States, 
provided that the fruit is produced in accordance with a systems 
approach, as an alternative to importation under the current 
preclearance program. The proposed systems approach for fresh apple and 
pear fruit consists of production site and packinghouse registration, 
inspection of registered production sites twice a season, production 
site pest control and sanitation, post-harvest safeguards, fruit 
culling, traceback, sampling, cold treatment against Mediterranean 
fruit fly in countries where the pest is known to occur, a 
phytosanitary certificate, port of entry inspection, and importation as 
commercial consignments only. Fresh apple and pear fruit that does not 
meet the requirements in the systems approach would continue to be 
allowed to be imported into the United States subject to the conditions 
of the preclearance program.
    This action would provide an alternative for the importation of 
fresh apple and pear fruit from certain countries in the European Union 
while continuing to provide protection against the introduction of 
plant pests into the continental United States.
    Implementing this rule will require an operational workplan, 
production site and packing house registrations, tracking system, 
monitoring, inspections, investigations, box markings, cold treatment 
burden requirements, and phytosanitary certificates.
    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 .00627 hours per response.
    Respondents: Foreign businesses and NPPOs.
    Estimated annual number of respondents: 72.
    Estimated annual number of responses per respondent: 2,230.
    Estimated annual number of responses: 160,553.
    Estimated total annual burden on respondents: 1,007 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 EGovernment 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.

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2. In Sec.  319.56-22, the introductory text of paragraph (a) is 
revised to read as follows:


Sec.  319.56-22  Apples and pears from certain countries in Europe.

    (a) Importations allowed. The following fruits may be imported into 
the United States in accordance with this section and all other 
applicable provisions of this subpart. See Sec.  319.56-75 for 
alternative provisions authorizing the importation of apples and pears 
from certain countries in Europe.
* * * * *
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3. Section 319.56-75 is added to subpart--Fruits and Vegetables to read 
as follows:


Sec.  319.56-75  Fresh apple and pear fruit from Belgium, Germany, 
France, Italy, Poland, Portugal, Spain and the Netherlands.

    Fresh apple (Malus domestica Borkh.) and fresh pear (Pyrus communis 
L.) fruit from Belgium, Germany, France, Italy, Poland, Portugal, 
Spain, and the Netherlands may be imported into the continental United 
States in accordance with the conditions listed in this section. See 
Sec.  319.56-22 for alternative provisions authorizing the importation 
of apples and pears from certain countries in Europe.
    (a) General requirements. (1) The NPPO of the exporting country 
must develop an operational workplan, subject to APHIS approval, that 
details the activities that the NPPO would carry out to meet the 
requirements of this section.
    (2) The fresh apple and pear fruit must be imported in commercial 
consignments only.
    (b) Production site requirements. (1) Production sites where the 
fresh apple and pear fruit is grown must be registered with the NPPO of 
the exporting country.
    (2) The registered grower of the production site must follow the 
phytosanitary measures agreed upon by APHIS and the NPPO of the 
exporting country in the operational workplan, including applying 
control measures that are authorized for use in the EU and the United 
States to reduce pest populations. The NPPO of the exporting country or 
officials authorized by the NPPO must monitor pest populations at 
production sites in order to determine the need and timing of such 
control measures and ensure effective control of pests. The NPPO must 
also ensure that registered production sites are inspected twice every 
season with emphasis on the quarantine pests listed in the operational 
workplan.
    (3) Any apple and pear propagative material introduced into 
registered production sites must be certified free of quarantine pests 
by the NPPO of the exporting country.
    (c) Packinghouse requirements. (1) All fresh apple and pear fruit 
for export to the continental United States must be packed in 
packinghouses that are registered and approved by the NPPO of the 
exporting country. Packinghouses must be able to exclude plant pests 
and have a tracking system to identify individual production sites in 
accordance with the operational workplan.

[[Page 3038]]

    (2) Packinghouses must not pack apple and pear fruit for other 
countries while packing for shipment to the continental United States. 
All leaves must be removed from the fruit to remove Leucoptera 
malifoliella, and packinghouse culling and inspection procedures must 
be followed to remove fruit with pupae of Leucoptera malifoliella.
    (3) All packed fruit intended for shipment to the continental 
United States must be safeguarded from infestation by fruit flies and 
other pests while at the packinghouse and during shipment to the 
continental United States in accordance with the operational workplan.
    (4) Apple and pear fruit must be held in a cold storage facility 
while awaiting export. If any other fruit from unregistered production 
sites are stored in the same facility, the apple and pear fruit must be 
isolated from that other fruit.
    (5) Each shipping box must be marked with the identity of the 
packing facility, the production site, and grower or grower 
organization to ensure traceback.
    (d) Mitigation for Mediterranean fruit fly. Apple and pear fruit 
being exported from countries where Mediterranean fruit fly is known to 
occur must undergo cold treatment in accordance with the phytosanitary 
treatments regulations in part 305 of this chapter. Cold treatment 
procedures and schedules will be included in the operational workplan.
    (e) Phytosanitary inspection. After post-harvest processing, the 
NPPO of the exporting country or officials authorized by the NPPO of 
the exporting country must inspect the apple and pear fruit for signs 
of pest infestation and confirm absence of the pests listed in the 
operational workplan. Upon detection of Adoxophyes orana, Alternaria 
gaisen, Argyrotaenia pulchellana, Ascochyta piricola, Ceratitis 
capitata, Grapholita (Cydia) funebrana, Leucoptera malifoliella, 
Monilinia fructigena and/or Monilinia polystroma in a consignment for 
export, the NPPO of the exporting country must reject the consignment 
and may, under conditions specified in the operational workplan, be 
required to suspend the production site and/or packinghouse from 
importation to the continental United States for the remainder of that 
season. If any of these pests are found in a consignment at U.S. ports 
of entry, APHIS may, under conditions specified in the operational 
workplan, reject the consignment and suspend the production site and/or 
packinghouse from importation to the continental United States until an 
investigation is completed by the NPPO of the exporting country and 
APHIS. The investigation may include site visits by APHIS and/or 
reports from the NPPO of the exporting country. Procedures for 
suspension of production sites and/or packinghouses will be detailed in 
the operational workplan. The exportation to the continental United 
States of fresh apple and pear fruit from a suspended production site 
and/or packinghouse may resume in the next growing season if an 
investigation is conducted and APHIS and the NPPO of the exporting 
country agree that appropriate remedial actions have been taken.
    (f) Phytosanitary certificate. Each consignment of fresh apple or 
pear fruit must be accompanied by a phytosanitary certificate issued by 
the NPPO of the exporting country certifying that the fruit meets the 
conditions under this section for export to the continental United 
States.

    Done in Washington, DC, this 13th day of January 2016.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2016-00992 Filed 1-19-16; 8:45 am]
BILLING CODE 3410-34-P