```

[Federal Register Volume 80, Number 78 (Thursday, April 23, 2015)]
[Rules and Regulations]
[Pages 22619-22635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09508]

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Rules and Regulations
                                                Federal Register
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having general applicability and legal effect, most of which are keyed 
to and codified in the Code of Federal Regulations, which is published 
under 50 titles pursuant to 44 U.S.C. 1510.

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Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules 
and Regulations

[[Page 22619]]

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

7 CFR Part 319

[Docket No. APHIS-2014-0003]
RIN 0579-AD89

Importation of Apples From China

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are amending the fruits and vegetables regulations to allow 
the importation of fresh apples (Malus pumila) from China into the 
continental United States. As a condition of entry, apples from areas 
in China in which the Oriental fruit fly (Bactrocera dorsalis) is not 
known to exist will have to be produced in accordance with a systems 
approach that includes requirements for registration of places of 
production and packinghouses, inspection for quarantine pests at set 
intervals by the national plant protection organization of China, 
bagging of fruit, safeguarding, labeling, and importation in commercial 
consignments. Apples from areas in China in which Oriental fruit fly is 
known to exist may be imported into the continental United States if, 
in addition to these requirements, the apples are treated with 
fumigation plus refrigeration. All apples from China will also be 
required to be accompanied by a phytosanitary certificate with an 
additional declaration stating that all conditions for the importation 
of the apples have been met and that the consignment of apples has been 
inspected and found free of quarantine pests. This action allows for 
the importation of apples from China into the continental United States 
while continuing to provide protection against the introduction of 
quarantine pests.

DATES: Effective May 26, 2015.

FOR FURTHER INFORMATION CONTACT: Mr. David B. Lamb, Senior Regulatory 
Policy Specialist, RPM, PPQ, APHIS, 4700 River Road Unit 133, 
Riverdale, MD 20737-1231; (301) 851-2018.

SUPPLEMENTARY INFORMATION: 

Background

    The regulations in ``Subpart--Fruits and Vegetables'' (7 CFR 
319.56-1 through 319.56-71, 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 that are new to or not 
widely distributed within the United States.
    The national plant protection organization (NPPO) of China has 
requested that the Animal and Plant Health Inspection Service (APHIS) 
amend the regulations to allow apples (Malus pumila) from China to be 
imported into the continental United States.
    In response to that request, we prepared a pest risk assessment 
(PRA) and a risk management document (RMD). Based on the conclusions of 
the PRA and the RMD, on July 18, 2014, we published in the Federal 
Register (79 FR 41930-41934, Docket No. APHIS-2014-0003) a proposal \1\ 
to amend the regulations to authorize the importation of fresh apples 
into the continental United States, provided that the apples were 
produced in accordance with a systems approach consisting of the 
following requirements: Production by a grower who is part of a 
certification program administered by the NPPO of China; fruit bagging; 
pre-harvest NPPO inspection; packing in packinghouses that are 
registered with the NPPO; packinghouse procedures including traceback 
and box marking; post-harvest washing; waxing; treatment with 
inspection after packing for quarantine pests; issuance of a 
phytosanitary certificate; importation in commercial consignments only; 
sealed boxes; and location of apples in a cold storage facility while 
awaiting export to the continental United States. For apples from those 
areas of China south of the 33rd parallel, where the Oriental fruit fly 
(Bactrocera dorsalis) is known to exist, we proposed to require 
treatment in accordance with 7 CFR 305.2, which provides that approved 
treatment schedules are set out in the Plant Protection and Quarantine 
(PPQ) Treatment Manual, found online at http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf.
---------------------------------------------------------------------------

    \1\ To view the proposed rule, its supporting documents, or the 
comments that we received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0003.
---------------------------------------------------------------------------

    We note that we are changing the bagging protocol from that which 
was set out in the proposed rule. The proposed systems approach would 
have required that bags remain on the fruit until its arrival at the 
packinghouse. In the final rule, we are requiring that the bags stay on 
until at least 14 days prior to harvest instead of remaining on the 
fruit until it reaches the packinghouse. Though we modeled the systems 
approach on a similar systems approach for the importation of pears 
from China, bag removal at this stage is a necessary practice among 
apple growers in countries where bagging protocols are employed as 
apples must be exposed to sunlight so that they may color up prior to 
harvest. Pears do not require similar treatment in order to achieve 
their coloration.
    Bagging is an important mitigation; however, we believe that 
removing the bags for the last 14 days before harvest is unlikely to 
significantly increase the risk because bagging is only one mitigation 
out of a number that are part of a systems approach.
    Apples produced south of the 33rd parallel will require an APHIS-
approved treatment for Oriental fruit fly. Specifically, this is 
fumigation plus refrigeration. This treatment will effectively mitigate 
any pests that might be present on the fruit after the removal of the 
bags.
    Most, if not all, of the apple production areas in China are north 
of the 33rd parallel. All of the Lepidoptera and Coleoptera listed in 
the PRA as following the pathway of fresh apples from China were 
assigned a medium risk of doing so. These pests are mitigated by a 
number of other factors apart from bagging, including commercial 
production only, culling at the packinghouse, and the required 
inspection by the NPPO of China.
    APHIS does not expect this change to significantly increase the 
risk of pests from China apples. Growers will still be responsible for 
maintaining low pest

[[Page 22620]]

populations of target quarantine pests, with oversight by the NPPO of 
China and APHIS. These measures and others, including removing fallen 
fruit, will maintain low pest populations in the production sites. The 
required culling will also remove pests from the pathway. The biometric 
sampling rate can be increased, if necessary, in order to look for 
pests that may be present in smaller numbers in consignments, thus 
heightening the level of phytosanitary security. In addition, the bags 
will be removed for 2 weeks in the fall, when temperatures are rapidly 
declining leading to winter and insects are prone to reduced activity 
leading to dormancy.
    Some of the pests of concern primarily attack the fruit early in 
the season when the fruit is at a small stage. For example, the 
Rhynchites spp. adult weevils attack small, newly formed fruit in the 
spring and early summer and the eggs are laid in those fruit often 
causing fruit drop. The larvae develop in 3 or 4 weeks after the eggs 
are laid and the larvae emerge from the fruit and pupate in the soil. 
There is only one generation per year. Infested fruit are misshapen 
with feeding damage and can easily be identified and culled. These 
pests are very unlikely to be present in the fruit in the fall when the 
bags are removed 2 weeks before the apples are harvested, and any 
infested, misshapen fruit would be unlikely to be packed and can be 
easily spotted upon inspection.
    Some of the Lepidoptera species do not attack the fruit, and are 
only present on the fruit as contaminants, for example Cryptoblabes 
gnidiella primarily attacks fruit that has infestations of Homoptera 
sp., which produce honey dew. Small larvae feed on the honey dew and do 
not attack the fruit until they have grown to a larger stage. The 
larvae initially feed on the surface of the fruit and do not bore into 
the fruit. Based on the pest damage symptoms, inspection and culling 
will remove Lepidoptera pests from the pathway.
    Carposina sasakii larvae may bore into the fruit near the calyx, 
but according to a 2014 data sheet from the European and Mediterranean 
Plant Protection Organization, ``Infested apples exude a sticky gum, 
pears turn yellow and apricots ripen unevenly.'' \2\ These symptoms 
would allow any infested fruit to be readily detected during culling 
and inspections. The window for the pests to attack after the bags are 
removed is also very small; for approximately 90 percent of the time 
after blossom drop and fruit set, the fruit will be protected by bags.
---------------------------------------------------------------------------

    \2\ You may view the data sheet on the Internet at https://www.eppo.int/QUARANTINE/insects/Carposina_sasakii/CARSSA_ds.pdf.
---------------------------------------------------------------------------

    The Euzophera spp. may also attack the bark of the trees as well as 
fruit. These pests build up in unmanaged and backyard fruit trees. 
Well-managed production sites will rarely have infestations.
    Leucoptera malifoliella, the pear leaf blister moth, is a leaf 
mining species that is only found on the fruit if leaves are attached 
to the fruit. Leaves and other plant parts are prohibited, so the risk 
of importing this pest with the fruit is minimal. This pest is an 
external miner; any leaves or mines should be readily detected and 
culled or found during inspection.
    The eight species of Tortricidae, (Adoxophyes orana, Archips 
micaceana, Argyrotaenia ljungiana, Cydia funebrana, Ulodemis trigrapha, 
Grapholita inopinata, Spilonota albicana, and Spilonota prognathana) 
are leaf rollers. They typically lay eggs on leaves and roll them up 
and feed on leaf tissue. When fruit are adjacent to leaves, the larvae 
may attack the fruit, usually leaving external feeding damage and 
sometimes boring into the fruit leaving visible holes and larval waste. 
These species are unlikely to be present in any numbers during the fall 
and are also expected to be controlled by required pest management and 
standard agricultural best practices. This, combined with the small 
amount of time that the fruit will be exposed when the bags are 
removed, will greatly reduce the possibility that these Tortricidae 
will follow the pathway. In addition APHIS readily inspects for 
Tortricidae on many commodities. The only time quarantine treatments 
are required is when high populations and frequent interceptions occur. 
APHIS does not expect this, but removal of production sites in any 
problem areas will allow APHIS to mitigate this risk further.
    As noted previously, the window for pest attack after the bags are 
removed is very small (approximately 90 percent of the time after 
blossom drop and fruit set, the fruit will be protected by bags). 
Attacks on the fruit by Lepidoptera and Curculionidae pests during this 
time are unlikely when these pest populations are kept in check by good 
pest management and agricultural practices, which has been our 
experience with pears from China and we expect this to be true for 
apples. All of the Lepidoptera and Curculionidae pests are borers into 
the fruit from eggs laid externally. Besides inspection for external 
oviposition, there will be larval holes and feeding damage and larval 
waste that is readily apparent on inspection. If necessary, APHIS can 
suspend production sites with pest interceptions until pest populations 
are mitigated.
    We are also adding two post-harvest treatment requirements to those 
listed in the proposed rule. The RMD that accompanied the proposed rule 
required apples to undergo washing and waxing. This procedure was 
included because washing removes hitchhiking, casual, and surface pests 
associated with smooth-skinned fruit such as apples, and waxing also 
serves to eliminate many surface pests including Homoptera and mites. 
Washing and waxing may also remove external spores of plant pathogens.
    The two treatments we are adding in this final rule are fruit 
brushing and spraying with compressed air. Fruit brushing will be 
required as an additional packinghouse treatment requirement, while 
spraying with compressed air will be an alternative to waxing. Brushing 
adds another level of phytosanitary protection against surface pests 
and external spores and spraying with compressed air serves the same 
purpose as waxing in removing hitchhiking, casual, and surface pests. 
While brushing and spraying with compressed air are not widely used in 
fruit processing in the United States, these treatments are commonly 
used in the fruit packing industry in China and other Asian countries. 
For example, in Sec.  319.56-65(c)(2), we require spraying with 
compressed air as a treatment for pineapples imported from Malaysia.
    We solicited comments concerning our proposal for 60 days ending 
September 16, 2014. We received 128 comments by that date. They were 
from a national organization that represents U.S. apple producers, 
State departments of agriculture, a State representative, scientific 
advisory groups, an environmental organization, domestic apple 
producers, and private citizens. The comments that we received are 
discussed below, by topic.

General Comments on the Proposed Rule

    One commenter asked what sort of outreach APHIS had conducted to 
publicize the availability of the proposed rule for comment. The 
commenter claimed that the number of comments received suggested that 
stakeholders and other interested parties were unaware of its 
existence.
    We disagree with the commenter's assessment. As stated above, we 
received 128 comments on the proposed rule from a variety of 
commenters. In addition to notifying members of PPQ's

[[Page 22621]]

Stakeholder Registry,\3\ we performed outreach activities to the 
following industry and trade groups: The U.S. Apple Export Council, the 
U.S. Apple Association, the Washington Apple Commission, the Northwest 
Horticultural Council, and the Apple Commodity Committee of Northwest 
Fruit Exporters.
---------------------------------------------------------------------------

    \3\ You may sign up for the PPQ Stakeholder Registry on the 
Internet at https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new/.
---------------------------------------------------------------------------

    A number of commenters stated that we produce sufficient apples 
domestically and should therefore not import apples from China.
    Such prohibitions would be beyond the scope of APHIS' statutory 
authority under the Plant Protection Act (7 U.S.C. 7701 et seq., 
referred to below as the PPA). Under the PPA, APHIS may prohibit the 
importation of a fruit or vegetable into the United States only if we 
determine that the prohibition is necessary in order to prevent the 
introduction or dissemination of a plant pest or noxious weed within 
the United States.
    Additionally, as a signatory to the World Trade Organization's 
Agreement on Sanitary and Phytosanitary Measures (SPS Agreement), the 
United States has agreed that any prohibitions it places on the 
importation of fruits and vegetables will be based on scientific 
evidence related to phytosanitary measures and issues, and will not be 
maintained without sufficient scientific evidence. The blanket 
prohibitions requested by the commenters would not be in keeping with 
this agreement.
    Another commenter suggested that we should instead focus on 
importing fruits and vegetables from Europe instead of China.
    APHIS's phytosanitary evaluation process only begins once a country 
has submitted a formal request for market access for a particular 
commodity. APHIS does not solicit such requests, nor do we control 
which countries submit requests.
    One commenter said that we should require that every imported apple 
be labeled as a product of China.
    Under the Country of Origin Labeling (COOL) law, which is 
administered by the Agricultural Marketing Service, retailers, such as 
full-time grocery stores, supermarkets, and club warehouse stores, are 
required to notify their customers with information regarding the 
source of certain food, including fresh and frozen fruits. Any apples 
imported from China would be subject to such requirements.
    Other commenters stated that, if imported Chinese apples were to be 
processed into products such as apple juice or applesauce, COOL would 
be circumvented.
    While, as stated above, APHIS does not administer COOL and, as 
such, these concerns are outside the scope of our authority, we believe 
that the relatively high price of apples imported from China when 
compared to domestic apple prices will prevent a situation such as the 
one described by the commenters. A full explanation of the economic 
factors associated with this rule, including apple pricing, see the 
section entitled, ``Executive Order 12866 and Regulatory Flexibility 
Act.''
    One commenter observed that the importation of apples from China 
would bypass U.S. regulations regarding plant origins, growing 
practices, and laborer and produce health standards set out by the U.S. 
Environmental Protection Agency (EPA), the U.S. Food and Drug 
Administration (FDA), and the U.S. Department of Labor (DOL).
    While we agree that Chinese producers are not subject to DOL rules 
and regulations, given that DOL's authority does not extend beyond the 
United States, we disagree with the assessment that apples from China 
would not be subject to agricultural standards. The regulations and the 
operational workplan set out requirements, including requirements 
regarding sourcing of apples only from registered places of production 
and growing practices which Chinese producers must meet in order to 
export apples to the United States. Further, the FDA samples and tests 
imported fruits and vegetables for pesticide residues. Yearly 
monitoring reports and information on the program may be found here: 
http://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/UCM2006797.htm.
    A number of commenters were concerned about the environmental state 
of China, citing in particular, heavy metal pollution in the Chinese 
air, water, and soil as a specific concern. The commenters further 
suggested that potential Chinese use of pesticides currently banned in 
the United States would lead to contamination of crops shipped from 
that country.
    While the United States does not have direct control over 
pesticides that are used on food commodities such as apples in other 
countries, there are regulations in the United States concerning the 
importation of food to ensure that commodities do not enter the United 
States containing illegal pesticide residues. Through section 408 of 
the Federal Food, Drug, and Cosmetic Act, the EPA has the authority to 
establish, change, or cancel tolerances for food commodities. These 
EPA-set tolerances are the maximum levels of pesticide residues that 
have been determined, through comprehensive safety evaluations, to be 
safe for human consumption. Tolerances apply to both food commodities 
that are grown in the United States and food commodities that are grown 
in other countries and imported into the United States. The EPA 
tolerance levels are enforced once the commodity enters the United 
States. Chemicals such as DDT that are banned in the United States do 
not have tolerances on food commodities. Federal Government food 
inspectors are responsible for monitoring food commodities that enter 
the United States to confirm that tolerance levels are not exceeded and 
that residues of pesticide chemicals that are banned in the United 
States are not present on the commodities. Tolerance levels for all 
chemicals that are acceptable for use on apples may be found in EPA's 
regulations in 40 CFR 180.101 through 180.2020. Tolerance information 
can also be obtained at http://www.epa.gov/pesticides/food/viewtols.htm. Pesticide use in China is regulated by the Institute for 
the Control of Agrochemicals (ICAMA) under the current pesticide 
management law, the ``Regulation on Pesticide Administration (RPA)''. 
Under this authority, all pesticides are required to be registered and 
all pesticide handlers must be licensed. In addition, the ICAMA 
restricts or bans the use of any pesticide when evidence shows that the 
pesticide is an imminent hazard to crops, fish, livestock, the 
environment, or public health.
    One commenter said that the FDA is currently unable to cope with 
its obligation to safety test the current level of imported food coming 
into U.S. markets. The commenter asserted that allowing the importation 
of apples from China would prove overly burdensome.
    As stated previously, the FDA samples and tests imported fruits and 
vegetables for pesticide residues. We have received no indication from 
the FDA that they are unable to successfully carry out these duties. 
Furthermore, the commenter provided no support for the assertions 
regarding the FDA's oversight capabilities.

Comments on APHIS Oversight

    Several commenters stated that there exists doubt that APHIS 
possesses the necessary resources to oversee and monitor the terms of 
the operational workplan and successfully intercept any quarantine 
pests as necessary. The commenters cited governmental budget cuts and 
staffing levels as the reason for these systemic weaknesses.

[[Page 22622]]

    APHIS has reviewed its resources and believes it has adequate 
coverage across the United States to ensure compliance with its 
regulations, including the Chinese apple import program, as established 
by this rule. In addition, the APHIS International Services Area 
Director in Beijing serves as APHIS' representative in China in order 
to assess the operations of the program there.
    Two commenters asked how APHIS will regulate apple shipments to 
avoid the importation of leaves and debris, which, the commenter 
stated, may pose a risk of introducing pests which may not feed or 
reproduce in or on the fruit.
    APHIS inspectors have the authority to reject consignments that 
contain contaminants such as leaves and other plant debris, especially 
if any pests are found to be generally infesting that shipment. As 
stipulated in Sec.  319.56-3(a), ``All fruits and vegetables imported 
under this subpart, whether in commercial or noncommercial 
consignments, must be free from plant litter or debris and free of any 
portions of plants that are specifically prohibited in the regulations 
in this subpart.''
    One commenter stated that APHIS would be unable to directly 
participate in the Chinese import program until such time as a pest 
infestation or other problem arose. The commenter suggested that APHIS 
expand its oversight to allow for action prior to that point.
    Contrary to the commenter's assertion, our standard practice is to 
conduct site visits prior to the initiation of any import program. This 
is to ensure that all required mitigations are in place and the agreed 
upon operational workplan is being enforced. Subject matter experts 
inspect production sites and packinghouses and report their findings to 
APHIS. Furthermore, the operational workplan authorizes the APHIS 
International Services Area Director in Beijing to conduct periodic 
audit visits of production sites.

Comments on Chinese Oversight

    A number of commenters expressed distrust in the Chinese NPPO's 
ability to maintain the program at an acceptable level of compliance. 
One commenter specifically cited an FDA report that highlights risks 
associated with China's inadequate enforcement of food safety 
standards. Another commenter stated that contaminants such as arsenic 
are of concern, citing a paper entitled ``Current Research Problems of 
Chronic Arsenicosis in China'' \4\ (June 2006).
---------------------------------------------------------------------------

    \4\ You may view the paper on the Internet at http://bioline.org.br/pdf?hn06022.
---------------------------------------------------------------------------

    Like the United States, China is a signatory to the SPS Agreement. 
As such, it has agreed to respect the phytosanitary measures the United 
States imposes on the importation of plants and plant products from 
China when the United States demonstrates the need to impose these 
measures in order to protect plant health within the United States. The 
PRA that accompanied the proposed rule provided evidence of such a 
need. That being said, as we mentioned in the proposed rule, APHIS will 
monitor and audit China's implementation of the systems approach for 
the importation of apples into the continental United States. If we 
determine that the systems approach has not been fully implemented or 
maintained, we will take appropriate remedial action to ensure that the 
importation of apples from China does not result in the dissemination 
of plant pests within the United States.
    The report referenced by the commenter was prepared by the United 
States Department of Agriculture's (USDA) Economic Research Service \5\ 
utilizing data collected by the FDA. The report found that three broad 
categories of products--fish and shellfish, fruit products, and 
vegetable products--combined accounted for 70 to 80 percent of FDA 
import refusals from China in recent years. Fruit and vegetable 
products are those that have been processed in China before being 
shipped to the United States, whereas the main concern when it comes to 
contamination of unprocessed fruits and vegetables is the presence of 
plant pests being introduced into the United States via the importation 
of unprocessed fruits and vegetables. Given the findings of the PRA, we 
are confident that the systems approach required for apples from China 
will mitigate the risk posed by such apples to introduce these pests. 
The other paper cited by the other commenter refers only to the effects 
of arsenic in drinking water and not to food contamination. As stated 
previously, FDA samples and tests imported fruits and vegetables for 
pesticide residues as well as other adulterants and additives, such as 
arsenic.
---------------------------------------------------------------------------

    \5\ The report, entitled, ``Imports From China and Food Safety 
Issues,'' (July 2009) may be viewed on the Internet at http://www.ers.usda.gov/media/156008/eib52_1_.pdf.
---------------------------------------------------------------------------

    Several commenters expressed concern that the rule gives authority 
for inspecting for pests to the NPPO of China and therefore U.S. 
phytosanitary security would be under the purview of a foreign 
government.
    While it is true that after initial APHIS approval of the export 
program is made, the required regular inspections are the 
responsibility of the NPPO of China, APHIS may request submission of 
inspection records at any time. In addition, port of entry inspection 
is performed by trained agriculture specialists employed by U.S. 
Customs and Border Protection (CBP).
    A commenter pointed out that we had modeled the systems approach on 
a similar systems approach for the importation of pears from China, and 
that pears imported under this protocol had sometimes been determined 
to be infested with plant pests. The commenter stated that this calls 
into question the efficacy of China's ability to employ the systems 
approach.
    The pest interceptions referred to by the commenter were 15 
infested pears over a 15 year period. Given the lengthy time period in 
question and the level of imports during that time, this interception 
rate does not call into question the efficacy of the systems approach, 
but rather underscores its quality.
    One commenter stated that Chinese producers are not subject to the 
same regulatory oversight as U.S. producers and therefore would be at a 
competitive advantage. The commenter said that the United States should 
not accept any produce or products from China for that reason.
    As stated previously, such a prohibition would be beyond the scope 
of APHIS' statutory authority under the PPA, whereby APHIS may prohibit 
the importation of a fruit or vegetable into the United States only if 
we determine that the prohibition is necessary in order to prevent the 
introduction or dissemination of a plant pest or noxious weed within 
the United States. Additionally, as a signatory to the World Trade 
Organization's SPS Agreement, the United States has agreed that any 
prohibitions it places on the importation of fruits and vegetables will 
be based on scientific evidence related to phytosanitary measures and 
issues, and will not be maintained without sufficient scientific 
evidence. The blanket prohibition requested by the commenters would not 
be in keeping with this agreement.
    One commenter said that, apart from the requirements specifically 
listed in the regulations and the operational workplan, the methods of 
growth, harvest, treatment, and export of apples from China are 
generally unknown. The commenter argued that this makes it difficult 
for APHIS to ensure that the apples were handled with care, without 
pesticides banned in the United States,

[[Page 22623]]

and with the precautions necessary to prevent the introduction of 
invasive pests. The commenter concluded that, until a more strictly 
monitored set of requirements are established, APHIS should not allow 
the importation of apples from China.
    We disagree with the commenter's assessment. The commenter is 
asking for certain requirements that either the mandatory systems 
approach does require or does not need to address for reasons we have 
explained above. Further, the commenter's characterization of the 
extent of the operational workplan is incorrect. While the regulations 
themselves are written more broadly to allow for programmatic 
flexibility, operational workplans establish detailed procedures and 
guidance for the day-to-day operations of specific import/export 
programs. 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 NPPO of China is expected to maintain program records for at 
least 1 year and provide them to APHIS upon request. One commenter 
asked why we only expect the NPPO of China to maintain program records 
for 1 year. The commenter suggested that we make record maintenance a 
permanent requirement.
    There is no technical justification for keeping records for longer 
than 1 year. If a pest problem is detected, the immediate past records 
will likely offer the most valuable information necessary to aid in 
resolution of the issue. This period of time is the APHIS standard for 
almost all pest programs and there is no special justification to 
extend it here.

General Comments on Phytosanitary Security

    A commenter expressed concern that apples from China pose a high 
risk of introducing quarantine pests into the United States. Another 
commenter asked that APHIS prove that any pests associated with the 
importation of apples from China would lend themselves to effective 
control measures if they were to become established in the United 
States. Another commenter asked if APHIS has experience with the listed 
pathogens to ensure that the proposed mitigations will be effective in 
controlling diseases that are not present in the United States. Another 
commenter said that the RMD's report of 15 pest interceptions in 15 
years in the Chinese pear importation program, which features a similar 
pest complex and mitigation measures as were proposed for Chinese 
apples, calls the efficacy of the systems approach into question. The 
commenter concludes that interception records cover only known 
interceptions and ignores the possibility of infested or diseased fruit 
that is imported but not detected.
    For the reasons explained in the proposed rule, the RMD, and this 
final rule, we consider the provisions of this final rule adequate to 
mitigate the risk associated with the importation of apples from China. 
The commenters did not provide any evidence suggesting that the 
mitigations are individually or collectively ineffective.
    One commenter suggested that past history bears out the fact that 
invasive species from China may prove to be destructive plant pests. 
The commenter cited the brown marmorated stink bug, Halyomorpha halys, 
and the vinegar fly, Drosophila suzukii, as two examples that are 
causing significant damage to American crops.
    As stated above, we consider the provisions of this final rule 
adequate to mitigate against the pests of concern as identified by the 
PRA. Specific to the commenter's examples, both pests have been present 
in the United States for many years and originated in Asia, not 
necessarily China in particular. The brown marmorated stink bug most 
likely entered the United States as a hitchhiking insect overwintering 
in a cargo container. Drosophila suzukii possibly made its initial 
entrance via importation of strawberries. Strawberries have been 
permitted entry from almost all countries since well before APHIS began 
requiring PRAs. Neither of these pests has been identified as being 
associated with a crop that has been permitted importation into the 
United States subsequent to the preparation of a PRA. Rather they are 
hazards of international trade, which occur infrequently over the span 
of decades.
    Another commenter stated that APHIS lacks information on the full 
range of pests associated with apples imported from China as Chinese 
literature sources have proven deficient or incomplete.
    We disagree. The PRA that accompanied the proposed rule provided a 
list of all pests of apples known to exist in China. This list was 
prepared using multiple data sources to ensure its completeness. For 
this same reason, we are confident it is accurate. Further, the pest 
complex associated with apples from China is very similar to the pest 
complex associated with pears from China, which have been imported into 
the United States for 15 years under a very similar systems approach 
with very few pest interceptions.
    Another commenter observed that certain areas in the United States 
must establish buffer zones to keep non-commercially grown apples 
separated from high production orchards in order to maintain pest 
freedom. The commenter stated that phytosanitary treatments or other 
measures, such as those we proposed to require for apples from China, 
were insufficient to achieve this separation domestically and therefore 
a similar quarantine is necessary in China.
    APHIS will require bagging and phytosanitary treatment to mitigate 
risk of fruit flies and other insects in apples imported from China. 
The bagging is an equivalent measure to a domestic quarantine since, 
done correctly, bagging excludes pest species from the fruits. We are 
also requiring additional mitigation measures including fumigation plus 
refrigeration for those apples grown in areas where the Oriental fruit 
fly is known to exist. In the United States, bagging is not used as a 
mitigation measure for fruit because of the labor requirements 
necessary to bag each fruit. Bagging is used as a mitigation for fruit 
from China, Japan, and Korea, because it is a culturally indigenous 
mitigation to those countries and because large scale labor at a lower 
cost is available to apply the mitigation.
    One commenter stated that while the RMD asserts that the designated 
phytosanitary measures will mitigate the risk presented by the 
importation of apples from China into the continental United States, 
the document makes no claim as to a specific amount of risk reduction. 
The commenter further states that the RMD does not establish an 
appropriate level of phytosanitary protection, or state that the listed 
mitigation measures will achieve such a level. The commenter said that 
the PRA should provide more precise and preferably quantitative 
information about the likelihood that imported apple fruit would 
transmit any actionable pest or disease. The commenter concluded that 
APHIS has never established or published any explicit level, either 
qualitative or quantitative, by which it consistently judges risk.
    APHIS believes that a qualitative analysis is appropriate in this 
situation. APHIS' evaluations are based on science and conducted 
according to the factors identified in Sec.  319.5(d), which include 
biosecurity measures, projected export quantity, and the proposed end 
use of the imported commodity (e.g., propagation, consumption, milling, 
decorative, processing, etc.). Most of APHIS' risk assessments have 
been, and continue to be, qualitative in nature. Contrary to the 
commenter's assertion

[[Page 22624]]

that a qualitative analysis should include an explicit level of 
phytosanitary protection, the relative flexibility afforded by a 
qualitative analysis allows us to evaluate commodity import programs in 
a holistic way.
    While APHIS believes that quantitative risk assessment models are 
useful in some rare cases, qualitative risk assessments, when coupled 
with site visit evaluations, provide the necessary information to 
assess the risk of pest introduction through importation of commodities 
such as apples from China. Additionally, there are several 
disadvantages associated with the use of quantitative risk assessment 
models. Quantitative models also tend to be data-intensive, and the 
types of data required by such models are often not available or 
adequate. Quantitative models are also necessarily developed using a 
set of assumptions that may not always adequately represent the 
biological situation in question, thus resulting in a wide range of 
uncertainty in interpretation of the model outcomes. The models also 
require constant updating, which is dependent on availability of 
current research and data, and thus may not always represent the 
current state of scientific information. Finally, uncertainty in the 
results or outcomes of quantitative models also arises from a large 
number of sources, including problem specification, conceptual or 
computational model construction and model misspecification, estimation 
of input values, and other model misspecification issues. Neither the 
regulations in 7 CFR part 319 nor APHIS guidance documents require a 
quantitative risk analysis or indicate that one is needed here.
    The same commenter said that the PRA's assessment that certain of 
the pests considered were ``unlikely'' or ``highly unlikely'' to follow 
the pathway of importation of apples from China was not the same thing 
as stating that these pests would never follow the pathway. The 
commenter went on to say that the PRA provides no quantitative 
indication of what level of incidence is signified by the 
determinations ``unlikely'' and ``highly unlikely.'' The commenter 
added that the systems approach specified in the proposed rule could 
prove ineffective if one of the pests deemed ``unlikely'' or ``highly 
unlikely'' to follow the pathway were imported, as the elements of the 
systems approach were not developed with those pests in mind.
    For the reasons stated previously, APHIS rarely performs 
quantitative risk assessments. However, just because the risk is not 
quantified does not mean it cannot be assessed and mitigated. Each 
organism carries its own risk of following the pathway, and APHIS has 
been very successful in assessing and mitigating the risks associated 
with new market access. We have stated in the past that if zero 
tolerance for pest risk were the standard applied to international 
trade in agricultural commodities, it is quite likely that no country 
would ever be able to export a fresh agricultural commodity to any 
other country. Our pest risk analysis process will identify and assign 
appropriate and effective mitigations for any identified pest risks. 
If, based on our PRA, we conclude that the available mitigation 
measures against identified pest risks are insufficient to provide an 
appropriate level of protection, then we will not authorize the 
importation of the particular commodity.
    The same commenter claimed that the brevity of the RMD, 
particularly the portion evaluating the efficacy of the proposed 
mitigation measures, was of concern given the biologic and economic 
complexities of the proposed action.
    It would be inappropriate for APHIS to include an economic analysis 
in the RMD. Our economic assessment of this action may be found in both 
the initial regulatory flexibility analysis that was made available 
with our July 2014 proposed rule and the final regulatory flexibility 
analysis prepared for this final rule. Copies of the full analyses are 
available on the Regulations.gov Web site (see footnote 1 in this 
document for a link to Regulations.gov) or by contacting the person 
listed under FOR FURTHER INFORMATION CONTACT.
    We disagree with the commenter's claim that the length of a 
document is in any way directly correlated to the efficacy of the 
mitigation measures discussed therein. The bagging requirements for all 
fruit intended for export will exclude almost all pests. We are 
confident of this fact because similar pest mitigations have 
successfully been used to allow for the importation of pears from 
China, which have a similar pest complex to apples from China. The pear 
importation program has been highly effective--15 pest interceptions in 
15 years--with an import volume of about 10,000 metric tons (MT) 
annually. Although the bagging requirement differs slightly from that 
used for pears, we have detailed previously why the phytosanitary 
protections are expected to be effective.
    The same commenter stated that the low interception rate reported 
in the RMD does not prove the efficacy of the proposed mitigation 
measures. The commenter argued that interception rates of fruit with a 
high actual infestation rate may be low or even zero if the inspection 
procedure has a low sensitivity or sampling rate. The commenter 
concluded that, because the RMD includes no information about 
inspection sensitivity or sampling rate, there is not enough 
information available to determine if the low interception rate truly 
reflects reality or if it is instead due to low inspection sensitivity 
or sampling.
    Generally, CBP inspectors use a sample rate of 2 percent as a 
standard sample rate. Specific sampling rates may be adjusted based on 
various factors including the inspector's experience working with the 
shipper and the type of fruits or vegetables being imported. The 
standard sample rate may be increased for smaller shipments, or for a 
shipper or commodity that the inspector is encountering for the first 
time. APHIS reserves the right to suspend a program and readjust 
sampling levels accordingly if unacceptable levels of pests are 
detected.
    The RMD included a description of packinghouse culling, which is a 
standard industry practice to remove all obviously blemished, diseased, 
and insect-infested fruits from the importation pathway. The same 
commenter argued that the RMD's supposition of the efficacy of culling 
ignores the potential existence of diseased, and insect-infested fruit 
that are not obviously diseased or insect-infested. The commenter said 
that, in the projected 10,000 MT of apples imported from China, the 
likelihood of a number of asymptomatic diseased or insect-infested 
fruit may not be negligible.
    We are confident that packinghouse culling, in concert with the 
other requirements of the systems approach will be effective in 
mitigating phytosanitary risk. Any fruit that appeared asymptomatic, as 
posited by the commenter, would likely be in the early stages of 
disease or infestation. Given the transit time required to ship apples 
from China to the United States as well as mandatory port of entry 
inspections, it is likely that any latent infection or infestation 
would be detected at this point in the importation process. We have 
stated in the past that if zero tolerance for pest risk were the 
standard applied to international trade in agricultural commodities, it 
is quite likely that no country would ever be able to export a fresh 
agricultural commodity to any other country and, thus, zero risk is not 
a realistic standard.

[[Page 22625]]

    The same commenter cited Article 5.4 of the SPS Agreement, which 
requires that members institute phytosanitary requirements while 
simultaneously minimizing negative trade effects; and Article 5.6, 
which requires that members ensure that any required phytosanitary 
measures are not more trade-restrictive than necessary, taking into 
account technical and economic feasibility. The commenter noted that 
the RMD contains no analysis indicating that the proposal is compliant 
with these articles and goes on to state that the RMD only evaluates 
one option, which consists of 14 specific measures. The commenter 
suggested that, if evaluated individually and in varying combinations, 
fewer than the 14 measures presented might prove sufficient to mitigate 
the phytosanitary risk posed by apples from China, a smaller systems 
approach that would be easier to implement and less trade-restrictive.
    APHIS has determined that the listed risk management measures, 
along with the requirement of a phytosanitary certificate and the port 
of entry inspection, will mitigate the risk of pest introductions on 
apples from China into the continental United States. While bagging is 
the primary mitigation, the other mitigations serve to ensure that no 
pests will follow the importation pathway. Once the system has been in 
place and is operational, it may become clear that some mitigations may 
be reduced or removed. Prior to the program becoming operational, APHIS 
will not remove mitigations since, as stated previously, a similar 
systems approach is successfully utilized for the importation of pears 
from China. Although the bagging requirement differs slightly from that 
used for pears, we have detailed previously why the phytosanitary 
protections otherwise remain the same.
    The commenter went on to state that the RMD provides no evidence to 
support the assertion that the 14 phytosanitary measures are sufficient 
to mitigate the pest risk associated with the importation of apples 
from China. In particular, the commenter observes that there is no 
description of apple growing or commercial apple processing in China 
that would support the claim that standard packinghouse procedures, 
such as culling and inspection, will prove efficacious. Similarly, 
another commenter stated that the required inspections do not guarantee 
that quarantine pests will not be introduced.
    APHIS (and its predecessor agencies within the USDA) has been 
relying on inspection for almost 100 years to remove pests and we are 
therefore confident in its efficacy as a mitigation. As stated 
previously, APHIS' evaluations are based on science and conducted 
according to the factors identified in Sec.  319.5(d). Specifically, 
paragraph (d)(5) of that section requires that any country requesting 
market access for a specific commodity to submit a full account of 
measures currently utilized in-country to mitigate against pests of 
concern in a domestic setting. We also require references to back up 
the information supplied by the country. APHIS then conducts its own 
assessment of the in-country mitigations, which includes multiple site 
visits in order to assess potential places of production, 
packinghouses, etc. We are confident that we have fully taken into 
account the ability of Chinese producers and the NPPO of China to meet 
the standards set out in the systems approach and the operational 
workplan.
    The same commenter stated that Article 6.3 of the SPS Agreement 
requires that, ``Exporting Members claiming that areas within their 
territories are pest- or disease-free areas or areas of low pest or 
disease prevalence shall provide the necessary evidence thereof in 
order to objectively demonstrate to the importing Member that such 
areas are, and are likely to remain, pest- or disease-free areas or 
areas of low pest or disease prevalence, respectively.'' The commenter 
said that APHIS does not provide any information about evidence 
provided by China concerning pest- or disease-free areas or areas of 
low pest or disease prevalence within China or within specific regions 
in China. The commenter concluded that it appears that APHIS never even 
considered the existence of pest- or disease-free areas or areas of low 
pest or disease prevalence.
    While the section of the SPS Agreement cited by the commenter is 
accurate concerning official recognition of pest- or disease-free areas 
or areas of low pest or disease prevalence, the recognition of such 
areas requires a formal request be made on the part of the exporting 
country. China did not request that APHIS recognize any such areas. 
Consequently, APHIS is not establishing formal pest- or disease-free 
areas or areas of low pest or disease prevalence in relation to the 
importation of apples from China, nor are such designations a 
requirement for the importation of commodities into the United States. 
As stated previously, we are confident that the systems approach 
provides the necessary pest mitigation for the importation of apples 
into the continental United States.
    The same commenter said that the PRA's lack of information 
concerning pest and disease prevalence in China calls into question the 
adequacy of China's pest and disease surveillance programs and added 
that the PRA does not provide the information necessary for a 
determination regarding the adequacy of pest and disease surveillance. 
The commenter stated that there may be pests and diseases of concern 
not considered by the PRA and RMD due to the potential inadequacy of 
Chinese phytosanitary surveillance.
    As stated previously, APHIS' evaluations are based on science and 
conducted according to the factors identified in Sec.  319.5(d). 
Specifically, the requirements of paragraphs (d)(4) and (d)(5) of that 
section require that any country requesting market access for a 
specific commodity must submit to APHIS a complete list of pests 
present in that country that are associated with the commodity in 
question as well as the measures currently utilized in-country to 
mitigate against those pests in a domestic setting. We also require 
references to back up the information supplied by the country. APHIS 
then conducts its own assessment of the pest complex and in-country 
mitigations, which includes multiple site visits in order to assess 
potential places of production, packinghouses, etc.
    Another commenter asked if APHIS will require a trapping program be 
established for the listed pests of concern.
    As stated in the proposed rule, paragraph (b)(1) would require the 
place of production to carry out any phytosanitary measures specified 
for the place of production under the operational workplan. Depending 
on the location, size, and plant pest history of the orchard, these 
measures may include surveying protocols or application of pesticides 
and fungicides. Trapping programs may be required in the case of fruit 
fly, key Lepidoptera, and/or weevils. This will be decided on a case-
by-case basis, with the details of any such programs laid out in the 
operational workplan.

Comments on the Pest List

    The PRA that accompanied the proposed rule identified 21 pests of 
quarantine significance present in China that could be introduced into 
the continental United States through the importation of Chinese 
apples:
     Adoxophyes orana (Fischer von R[ouml]slerstamm), summer 
fruit tortix.
     Archips micaceana (Walker), a moth.
     Argyrotaenia ljungiana (Thunberg), grape tortix.

[[Page 22626]]

     Bactrocera dorsalis (Hendel), Oriental fruit fly.
     Carposina sasakii Matsumura, peach fruit moth.
     Cenopalpus pulcher (Canestrini & Fanzago), flat scarlet 
mite.
     Cryptoblabes gnidiella (Milli[egrave]re), honeydew moth.
     Cydia funebrana (Treitschke), plum fruit moth.
     Euzophera bigella (Zeller), quince moth.
     Euzophera pyriella Yang, a moth.
     Grapholita inopinata Heinrich, Manchurian fruit moth.
     Leucoptera malifoliella (Costa), apple leaf miner.
     Monilia polystroma van Leeuwen, Asian brown rot.
     Monilinia fructigena Honey, brown fruit rot.
     Rhynchites auratus (Scopoli), apricot weevil.
     Rhynchites bacchus (L.), peach weevil.
     Rhynchites giganteus Krynicky, a weevil.
     Rhynchites heros Roelofs, a weevil.
     Spilonota albicana (Motschulsky), white fruit moth.
     Spilonota prognathana Snellen, a moth.
     Ulodemis trigrapha Meyrick, a moth.

We received a number of comments regarding these pests as well as 
suggestions for other pests commenters believed to be of phytosanitary 
significance that were not included.
    One commenter stated that many irrelevant species, such as longhorn 
beetles (Cerambycidae sp.), were included in the PRA. The commenter 
said that the PRA should focus only on those pests associated with 
apple fruit or those that could be transported with the commodity. The 
commenter said that including a number of species that do not meet 
those criteria results in a large document, which renders it difficult 
to assess pests that may be of true significance and thus determine the 
quality and value of the PRA.
    Our task in developing the PRA was to review all pests of apple 
that are present in China and then assess how likely they are to be 
associated with harvested fruit. For the sake of transparency, we 
include those pests that we conclude are not of quarantine significance 
or unlikely to follow the pathway of importation as we must first 
identify all pests that exist in China before narrowing the list to the 
specific pests of concern. This allows stakeholders and other 
interested parties the fullest degree of access to the pest list.
    Another commenter wanted to know whether the reference to ``stem'' 
as the plant part affected in the PRA includes the fruit pedicel, which 
may, in some cases, be attached to the fruit in the marketplace. The 
commenter said that if the term ``stem'' refers only to woody tissue, 
such as an apple branch, then the commenter agrees with many of the 
assessments made regarding infestation of stems and the likelihood of 
such a pest following the pathway of importation. The commenter went on 
to state that many of the pests in the Cerambycidae, Lucanidae, 
Scolytinae, Tenebrionidae, and Curculionidae species listed in the PRA 
may infest stems and also the fruit pedicel, which would mean they 
could potentially pose a phytosanitary risk.
    We considered the importation of apple fruit only, with no stem 
attached. This does not include the fruit pedicel.
    Another commenter observed that the PRA did not consider the risks 
posed by those pests of phytosanitary concern in the United States that 
may be present in China but are not currently reported or known to be 
present. The commenter additionally stated that the PRA did not 
consider the risks posed by those pests that are of phytosanitary 
concern in the United States that are present in China but not 
currently reported to be associated with apples.
    A second commenter stated that one of the general challenges 
encountered in reviewing the PRA is in understanding the biology of 
some of the exotic insect species and the specific risk of early season 
latent infection or late season infestation that may not be 
unequivocally obvious at harvest.
    We believe that the standard suggested by the commenters would call 
for APHIS to postulate based on wholly unknowable risk factors. The PRA 
that accompanied the proposed rule provided a list of all pests of 
apples known to exist in China. This list was prepared using multiple 
data sources to ensure its completeness. For this same reason, we are 
confident it is accurate.
    If, however, a new pest of apples is detected in China, APHIS will 
conduct further risk analysis in order to evaluate the pest to 
determine whether it is a quarantine pest, and whether it is likely to 
follow the pathway of apples from China that are imported into the 
United States. If we determine that the pest is a quarantine pest and 
is likely to follow the pathway, we will work with the NPPO of China to 
adjust the pest list and related phytosanitary measures to prevent its 
introduction into the United States.
    Since the Oriental fruit fly is known to exist, in varying 
population densities, in areas of China south of the 33rd parallel, 
apples from such areas will be subject to treatment in accordance with 
7 CFR part 305. Within part 305, Sec.  305.2 provides that approved 
treatment schedules are set out in the PPQ Treatment Manual, found 
online at http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf. (The manual specifies that fumigation plus 
refrigeration schedule T108-a is effective in neutralizing Oriental 
fruit fly on apples.) The RMD also states that any other treatment 
subsequently approved by APHIS may be used. One commenter expressed 
concern at the non-specific nature of those potential alternative 
treatments.
    While APHIS cannot offer specifics on phytosanitary treatments that 
are not currently approved for use, the language in the RMD is intended 
to indicate that such treatments may become available in the future. 
APHIS has a rigorous procedure for approving new quarantine treatments, 
which includes soliciting comments from stakeholders in accordance with 
Sec.  305.3. New treatments are tested to a very high standard of 
efficacy. Generally speaking, that means that an approved treatment is 
effective in removing 99.99 percent of pests.
    Another commenter said that there is a lack of research to support 
that the systems approach proposed by APHIS will be effective in 
mitigating the phytosanitary risk posed by the Oriental fruit fly.
    We disagree with the commenter's assertion. These mitigations have 
been used on a similar pest complex for the importation of pears from 
China. This is a highly successful import program with only 15 
interceptions of any quarantine pests in 15 years of operation and no 
fruit fly interceptions. As most apples in China are grown above the 
33rd parallel, the risk of fruit fly interceptions in consignments of 
apples is small. The commenter provided no specific data to support the 
argument that apples from China pose a unique pest risk.
    One commenter stated that the Oriental fruit fly and the apple leaf 
miner are of particular concern given that they are high risk pests and 
Oriental fruit flies have been detected on numerous occasions at U.S. 
ports of entry.
    While it is true that APHIS has made interceptions of Oriental 
fruit fly at U.S. ports of entry, most of those interceptions were in 
passenger baggage. Oriental fruit fly is additionally present in 
Hawaii, which may lead to a higher number of interstate interceptions.

[[Page 22627]]

    Another commenter said that melon fly (Bactrocera cucurbitae) and 
solanum fruit fly (Bactrocera latifrons) are known pests of apple, but 
the PRA states that non-cucurbit hosts require confirmation. The 
commenter reasons that, for such severe pests of commodities other than 
apple, it would make sense to consider both as potential pests of 
apple. The commenter asked if there are areas of overlap between the 
flies' distribution areas and apple growing areas. Lastly, the 
commenter said that the honeydew moth (Cryptoblabes gnidiella) remained 
on the list in spite of the facts that the pest has a warm climate 
distribution and that apple is only an occasional host. The commenter 
said it would therefore be consistent to treat melon fly and solanum 
fruit fly similarly.
    These particular fruit flies are not found in apple producing parts 
of China and, as the commenter observes, apple is not a primary host. 
Thus infestations of apple would be unusual and exclusionary 
mitigations like bagging will help prevent any infestation. We found 
references indicating the host status of apples (regardless of major or 
minor status) for the honeydew moth whereas we did not for either melon 
fly or solanum fruit fly. If, upon inspection, melon fly or solanum 
fruit fly are found to be generally infesting shipments of apples we 
will adjust our mitigations as necessary.
    One commenter stated that there is an unknown risk of apple leaf 
miner escaping detection.
    We disagree with the commenter's claim that apple leaf miner may 
easily escape detection. Leaf miners are not typically found on fruit; 
leaves, which they more readily infest, are not authorized for 
importation. In addition, leaf miners typically leave a visible tunnel 
as they mine, which aids in inspection and detection.
    Another commenter asked why apple ring rot (Macrophoma kawatsukai) 
and the fungus, Penicillium diversum, were removed from the pest list 
when both were present on a draft version of the list. The commenter 
asked why the genus Penicillium is considered non-actionable at ports 
of entry.
    These pests are post-harvest pathogens. In general, post-harvest 
pathogens are not considered for analysis because most are cosmopolitan 
and it is unlikely to impossible for them to be transferred to fruit in 
the field. Penicillium is a cosmopolitan genus that only causes post-
harvest rots. Consequently, it is not actionable. APHIS determines 
whether a pest is actionable based on its novelty and known prevalence 
or distribution within and throughout the United States, its potential 
harm to U.S. agricultural, environmental, or other resources, and the 
need to mitigate its pest risk, if any.
    The same commenter stated that spores from the fungal pathogens 
Monilia polystroma and Monilinia fructigena might easily go undetected 
in inspections and present a risk of becoming established on several 
crops in the State of Florida.
    Phytosanitary security is provided by several layers of inspection: 
Field inspection, packinghouse inspection, and port of entry 
inspection. As these inspections take place over a period of time, it 
becomes increasingly likely that any consignments with symptomatic 
fruit will be identified. As stated previously, these mitigations have 
been successfully used on a similar pest complex for the importation of 
pears from China.
    The same commenter stated that, contrary to APHIS's assertion in 
the PRA that interception records indicate no association between 
Tetranychus species of spider mite and commercially produced and 
shipped apples, the apple industry has experienced infestations of 
Tetranychus and Panonychus spider mite species in apple production 
areas. The commenter added that the hawthorn spider mite 
(Amphitetranychus viennensis) could present a similar risk given that 
it is recorded as attacking leaves, fruit, and blossoms. Another 
commenter stated that, late in the growing season, hawthorn spider 
mites sometimes collect in the calices of apples, with either motile 
forms or eggs present. The commenters urged APHIS to reexamine the data 
in light of this.
    While we have made no changes in response to this comment, as the 
data we have do not support the commenters' assertion, we do note that 
typical required mitigations for spider mites are packinghouse 
procedures (i.e., washing, brushing, spraying with compressed air), 
culling, and inspection. Those measures will be included as 
requirements in the operational workplan and should mitigate against 
any unforeseen pests of this nature. If one of these pests is detected 
upon inspection we will take appropriate measures to prevent its 
introduction into the United States. The hawthorn spider mite was 
considered in the PRA. It attacks apple leaves; we found no evidence of 
it being present on fruit.
    The same commenter asked why Eotetranychus sp. mites were listed as 
being associated with apples in China with actionable or undetermined 
regulatory status but was not included in the listing of actionable 
pests reported on apples in any country and present in China on any 
host.
    While Eotetranychus sp. mites are generally actionable, 
investigation into the Eotetranychus species that are present in China 
and known to affect apples did not reveal any known species that are 
considered actionable in the United States, so we did not include them 
in the second listing. Some non-actionable species from this genus are 
listed in an appendix to the PRA.
    The same commenter expressed concern that multivoltine fruit 
feeding insects may be able to oviposit on fruit once the bags that are 
required by the systems approach to be placed over each developing 
fruit are removed. The commenter further asked that APHIS ensure that 
the required fruit bags are not applied too late in the spring or 
removed too early as the fruit matures in the interest of addressing 
horticultural quality needs and color development at the expense of 
pest mitigation.
    Our requirement, which will be stipulated in the operational 
workplan, is that the bags must remain on the fruit until at least 14 
days before harvest. PPQ will ensure that the bags are in place early 
enough to exclude insect pests. If infestations of insects such bagging 
is intended to exclude are found upon inspection, production sites and 
packinghouses may be suspended from the export program.
    The same commenter stated that snout beetles (Curculionidae) can be 
serious pests of tree fruit with limited control options. While the 
commenter noted that the PRA lists a number of Curculionidae species as 
following the importation pathway, the commenter noted the following 
additional species of weevils for inclusion: Coenorrhynus sp., 
Enaptorrhinus sinensis Waterhouse, Involvulus sp., Neomyllocerus hedini 
(Marshall), Rhynchites coreanus Kono, and Rhynchites heros Roelofs.
    In particular, the commenter asked why Enaptorrhinus sinensis 
Waterhouse is listed as infesting fruit, but unlikely to follow the 
pathway of importation. The commenter observed that Enaptorrhinus 
sinensis Waterhouse is one of three species on the PRA list of 
quarantine pests that are likely to follow the pathway that is classed 
as a fruit feeder. The commenter went on to state that Neomyllocerus 
hedini (Marshall) is also present on the PRA list of quarantine pests 
that are likely to follow the pathway.
    Finally, the commenter stated that an Australian PRA cites 
Rhynchites coreanus Kono as a high-risk quarantine

[[Page 22628]]

pest from China, but was not considered in the APHIS PRA.
    The bagging requirement discussed above should effectively exclude 
Curculionidae. In addition, weevils typically leave feeding damage and 
holes with frass that are easily visible upon inspection. We would note 
that we analyzed Rhynchites heros Roelofs and determined that it 
presents a medium risk of introduction via the importation pathway and 
that Rhynchites coreanus Kono is a synonym of Rhynchites heros Roelofs.
    Contrary to the commenter's assertion, Enaptorrhinus sinensis 
Waterhouse is not listed in the PRA as affecting fruit: ``Adults, which 
are moderately large beetles (body length: 6.2-6.4 mm, width: 3.2-3.3 
mm; Han, 2002), may feed on apple fruit (You, 2004), but are considered 
unlikely to remain with fruit through harvest and post-harvest 
processing.'' Neomyllocerus hedini (Marshall) is listed as affecting 
leaves but not fruit.
    As for the other weevils cited by the commenter, we found no 
evidence during our assessment that those pests were likely to follow 
the pathway.
    The same commenter observed that, since members of the Diapididae 
and Pseudococcidae families of scale insects feed on stems, leaves, and 
fruit in U.S. apple orchards and are treated as quarantine pests in 
many countries around the world, the following species should have been 
included in the PRA: Diaspidiotus (= Quadraspidiotus) slavonicus 
(Green), Phenacoccus pergandei Cockerell, Spilococcus (= Atrococcus) 
pacificus (Borchsenius), and Leucoptera malifoliella (Lyonetiidae).
    Another commenter said that the PRA's determination of a negligible 
possibility of Japanese wax scale (Ceroplastes japonicas) following the 
pathway of importation was based on the idea that Chinese apples will 
be safely discarded. The commenter stated that, if even a small 
percentage of imported apples are discarded improperly, there is risk, 
particularly if they are discarded near host material.
    In general, scale insects are excluded via washing, brushing, 
spraying with compressed air, culling, and inspection. These mandatory 
measures will be a part of the operational workplan. However, 
Phenacoccus pergandei Cockerell is found to affect leaves only, 
Spilococcus (= Atrococcus) pacificus (Borchsenius) is found to affect 
stems only, and Ceroplastes japonicas is found to affect both leaves 
and stems. The commenters provided no evidence that these scales were 
of concern on fruit. Although Leucoptera malifoliella (Lyonetiidae) is 
not on the pest list, Leucoptera malifoliella (Costa) is listed with a 
high risk of following the pathway and will be mitigated as described 
previously. Lyonetiidae is the family name for this pest, Costa is the 
authority. They are the same pest, notated differently. Finally, in a 
risk analysis titled, ``Phytosanitary Risks Associated with Armored 
Scales in Commercial Shipments of Fruit for Consumption to the United 
States'' (June 2007) \6\ we determined that the likelihood of 
introduction of armored scales via the specific pathway represented by 
commercially produced fruit shipped without leaves, stems, or 
contaminants is low because these scales have a very poor ability to 
disperse from fruits for consumption onto hosts. Females do not possess 
wings or legs; legs are also absent in feeding immature forms. Males 
are capable of flight, however they are short-lived, do not feed, and 
tend to mate only with nearby females. For this reason, the armored 
scale Diaspidiotus (= Quadraspidiotus) slavonicus (Green) is not a pest 
of concern.
---------------------------------------------------------------------------

    \6\ Copies of the full analysis are available by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT.
---------------------------------------------------------------------------

    One commenter stated that since the taxonomy of the fungus 
Botryosphaeria dothidea is under active consideration by the research 
community, the assertion that the Asian Botryosphaeria dothidea is the 
same species as is found in the United States is not settled science. 
The commenter argued that they should be considered distinct species 
until scientists from China provide additional studies demonstrating 
that they are synonymous.
    We disagree. The most recent and conclusive study on this matter 
\7\ found that the causal agent of apple ring spot and apple white rot 
was the same. The agent was identified as Botryosphaeria dothidea for 
both diseases. Thus, the pathogen is present in both the United States 
and China.
---------------------------------------------------------------------------

    \7\ That study, Phylogenetic and pathogenic analyses show that 
the causal agent of apple ring rot in China is Botryosphaeria 
dothidea, may be found on the Internet at http://apsjournals.apsnet.org/doi/pdf/10.1094/PDIS-08-11-0635.
---------------------------------------------------------------------------

    Another commenter stated that there is an unknown risk of fungi of 
the genus Monilinia escaping detection.
    We disagree with the commenter's assertion regarding unknown risk. 
Monilinia mali is unlikely to be present on mature fruit. Monilinia 
fructigena is unlikely to come in contact with host material, since 
spores need to be near actual apple trees. Unless Monilinia fructigena-
infected fruit are sporulating in close proximity to host material, 
they cannot infect it and we consider this possibility unlikely. Other 
specific members of Monilinia sp. are discussed below.
    One commenter said that it needs to be demonstrated, through 
scientific study and examination of mature fruit taken from orchards 
which have suffered epidemics at several early seasonal timings, that 
latent infections of the fungus Monilinia ma/1, which is the causal 
agent of monilia leaf blight, are not sometimes still present later at 
harvest on normal appearing fruit.
    Field inspection data for Monilinia fructigena and Monilinia 
polystroma was presented by all orchards inspected in our site visit 
and certified by the Chinese Entry and Exit Inspection and Quarantine 
Service. This data shows no report of the diseases, and if there are no 
disease records, then there can be no latency problem such as the 
commenter described. In addition, packinghouse inspections show no 
history of the disease.
    The same commenter said that the fungus Monilinia mali, which does 
not occur in the United States, was not included in the listing of 
actionable pests reported on apples in any country and present in China 
on any host and should be added. The commenter additionally stated that 
the fungus Monilinia polystroma should be added to that list as well, 
as it has been reported to attack apples in Europe and has been 
recently reported from China.
    Contrary to the commenter's assertion, both pathogens are listed. 
Currently there is only a single report of Monilinia polystroma on 
apples. That identification is debatable since it was based on 
molecular evidence alone. The European report stated that the symptoms 
disappeared after the initial observation. Thus, the observations have 
not been replicated outside of this single incident. In Japan and 
China, where stone fruit (the primary host for the pathogen) and apples 
are grown in close proximity, there are no reports of Monilinia 
polystroma on apples. Despite the weak evidence, we did analyze 
Monilinia polystroma and found it to be high risk. It was therefore 
considered when we were developing the requirements of the systems 
approach and will be considered in development of the operational 
workplan. There is also considerable uncertainty about the presence of 
Monilinia mali but it was also listed. However, it was not analyzed 
because it is not found on mature fruit.
    The PRA lists certain organisms that APHIS is only able to identify 
to the

[[Page 22629]]

genus level and notes that these organisms may prove to have actionable 
status. One commenter noted this and categorized this as an arbitrary 
decision by APHIS. The commenter stated that APHIS is incorrect to say 
that the risk potential of these species should be considered low 
because APHIS cannot evaluate risk as completely as would be desirable. 
The commenter appears to suggest that APHIS study these unknown 
organisms further or that APHIS evaluate risk for genera taken as a 
whole.
    Another commenter requested further information regarding the 
following fungi, identified only to the genus level, which were listed 
as being associated with apples in China with actionable or 
undetermined regulatory status: Cladosporium, Fusarium, Fusidium, 
Penicillium, and Psuedocercospora. The commenter stated that these may 
represent novel species and wanted to know if APHIS went back to 
original sources or voucher specimens to attempt to confirm the 
specific identity of these fungi.
    Another commenter observed that some pest organisms were only 
identified to the genus level in the PRA and are thus not included in 
the evaluation. The commenter particularly cited Drosophila sp. as of 
potential concern, stating that, though many members of the species 
only attack and reproduce in damaged fruit, the U.S. apple industry has 
found that the spotted-wing drosophila (Drosophila suzukii) readily 
attacks and reproduces in intact fruit. The commenter said that this 
behavior is present in many plant-attacking arthropods and added that 
the Chinese arthropod fauna is very poorly known and therefore we have 
no idea of their geographic or host ranges and, consequently, their 
possible agricultural and ecological impacts.
    These commenters ask APHIS to meet an impossible standard of 
certainty in terms of species knowledge. Further, the SPS Agreement 
allows for signatory countries to only consider risks that are known 
and scientifically documented. Under the SPS Agreement, if a country 
cannot scientifically document the risk associated with a given pest or 
commodity as a whole, then that country cannot mitigate that unknown 
risk by imposing phytosanitary requirements or denying market access. 
We do not have access to any further information on the specific 
species cited by the commenters as there is no existing research on 
these species beyond the genus level. While, as stated, we are unable 
to assess the risk associated with scientifically unknown species, we 
include the genera in the PRA in case more information is discovered 
later. In the event of new pest information and research, we will 
adjust our mitigations as necessary.
    Another commenter stated that the sooty blotch and flyspeck complex 
of fungi, which occurs in China, represents a phytosanitary challenge 
given that most of these fungi have an extremely long incubation period 
or latent period before colonies become visible on fruit surfaces. 
Additionally, the commenter identified three species, Zygophiala 
cylindrical, Zygophiala qianensis, and Strelitziana mali, which are 
reported to occur on apples in China but are not included on the pest 
list.
    As with Penicillium, which was discussed previously, these pests 
are post-harvest pathogens. In general, post-harvest pathogens are not 
considered for analysis because most are cosmopolitan and it is 
unlikely to impossible for them to be transferred to fruit in the 
field.
    The same commenter observed that nematodes are often mistakenly 
considered to be solely root feeders. While root feeders would not 
likely be expected to be part of the fruit pathway, Aphelenchoides 
limberi, a shoot feeder, might present a higher risk than assigned in 
the pest list and therefore be deserving of additional consideration. 
The commenter asked why no Ditylenchus or Anguina species were included 
in the PRA, given the regional proximity of seed-gall nematode, Anguina 
tritici.
    As the commenter stated, generally speaking, nematodes inhabit the 
soil and infest plant roots. While there are a few tissue feeding 
species, it is highly unlikely that any will be present on apples given 
that they are shoot feeders and not pathogens of the mature fruit. We 
are confident that the PRA has captured all fruit feeding pests of 
concern.
    The same commenter observed that the moth Spulerina astaurota, the 
lace bug (Stephanitis (Stephanitis) nashi Esaki & Takeya, 1931), and 
the tortricid moths Acleris fimbriana, Adoxophyes orana, and Spilonota 
lechriaspis are listed as associated with fruit in a 2003 Australian 
review of pests associated with Chinese pears. The commenter said that 
this association should prove true for apples from China as well and 
these pests should therefore be added to the pest list.
    We are aware of the review referenced by the commenter but disagree 
with the commenter's conclusions. Our examination of the source 
literature for the review as well as other documents did not indicate 
that any of these pests, with the exception of Adoxophyes orana, is 
present on apple fruit. Adoxophyes orana was analyzed in the PRA and we 
determined that it presents a medium likelihood of introduction. It is 
therefore covered by the mitigations in the systems approach.
    Another commenter asked why the summer fruit tortix (Adoxophyes 
orana) and the plum fruit moth (Cydia funebrana) would not require an 
approved treatment in regions where these pests are present, as will be 
required for Oriental fruit fly.
    These pests are mitigated by the required bagging protocol that is 
part of the systems approach. Bagging excludes all Lepidoptera pests. 
This systems approach has been used for pears from China for the past 
15 years, resulting in a very low number of Lepidoptera sp. 
interceptions.
    Another commenter stated that, although there are four species of 
thrips (Thysanoptera) listed in the PRA, none were considered to follow 
the pathway of importation since they only damage leaves. The commenter 
said that many thrips are known to shelter in the calyxes of fruit and 
could enter the importation pathway in this manner.
    We disagree with the commenter's assessment. Apart from principally 
attacking leaves, thrips are a highly mobile pest. Any thrips that 
sheltered in the fruit calyx or elsewhere would not do so for long and 
would be mitigated by the required washing, brushing, and spraying with 
compressed air at the packinghouse.
    The same commenter said that the PRA did not consider the pear 
fruit borer (Pempelia heringii) as a candidate for risk management 
based primarily on the fact that it has not been a significant pest in 
the last 100 years, but that records indicate that it was a pest that 
bored into the fruit of apples and pears. The commenter stated that a 
report of this species in Hawaii throws into doubt the restricted host 
range it is thought to have and therefore the precautionary principle 
should be applied in including it on the pest list.
    One of the risk elements analyzed in the guidelines for risk 
assessment is damage potential in the endangered area. Considering all 
available information, the analysis determines whether or not a 
significant level of damage would be likely to occur in the endangered 
area (e.g., more than 10 percent yield loss, significant increases in 
production costs, impacts on threatened or endangered species). As the 
commenter notes, reports of significant damage in fruit production as a 
result of Pempelia heringii infestation are over 100 years old. Apple 
and pear production in China and Japan are economically important 
aspects of

[[Page 22630]]

national agriculture; if significant damage was to occur again, it 
would have been reported in the literature. While there is some 
uncertainty regarding the cause of the absence of Pempelia heringii 
infestations, based on available literature, the potential for damage 
in the United States is considered low.
    The same commenter stated that the mealybug Pseudococcus cryptus 
was not considered a candidate for risk management in the PRA because 
risk of establishment was considered first, and since that was deemed 
negligible, the likelihood of introduction was not evaluated. The 
commenter said the argument regarding negligible establishment is based 
on the idea that it is unlikely that an infested fruit will be 
discarded near a potential host, as well as the presumed frailty of the 
crawlers. The commenter went on to say that, in the event that apples 
are or become a host, the crawlers of other mealybug species are known 
to aggregate around the calyx of fruit, which would provide shelter and 
render them difficult to detect and therefore the absence of any 
mealybug species from the PRA list for risk management measures should 
be examined.
    The mealybug analysis concludes as follows: ``Dispersal by wind is 
dependent on prevailing wind direction; nymphs have no control over 
where they are blown. This dispersal strategy relies on a very high 
number of nymphs, so that a few will arrive serendipitously on a 
suitable new host. Commercial fruit arriving in the United States is 
highly unlikely to carry high populations of pregnant females. Crawlers 
would be unlikely to survive shipment, especially in chilled, low 
humidity conditions. Some people dispose of inedible fruit in outdoor 
compost bins, but since only a small number of fruit are likely to be 
infested, only very rarely would infested fruit be composted. For these 
reasons, mealybugs arriving on commercial fruit for consumption have a 
negligible likelihood of dispersing to hosts.'' Sufficient evidence to 
change this has not been presented.
    The same commenter observed that the oriental red mite 
(Eutetranychus orientalis) was dismissed as a risk by the PRA as there 
were no records indicated in a ``thorough National Agricultural 
Library, Google Scholar, and PestID database search.'' The commenter 
stated that, to the contrary, there is literature that lists 
Eutetranychus orientalis as a pest of apple and other rosaceous hosts.
    This species is a well-known and thoroughly researched pest of 
citrus. Given the vast amount of literature available on this species, 
primary records of detections on apple should be available, if extant. 
Given the lack of such primary records, we consider the listing of 
apples as a natural host for Eutetranychus orientalis dubious and 
therefore we did not include it on the pest list.
    The same commenter stated that the peach fruit moth (Carposina 
sasakii) is treated as not meeting the criteria for spread potential in 
the PRA, but that the PRA also states that the lack of spread is due to 
strict quarantine regulations. The commenter went on to say that this 
is a serious pest in infested regions and should be included for risk 
management.
    We concluded in the PRA that the peach fruit moth was likely to 
cause unacceptable consequences if introduced into the United States. 
It was assigned a medium likelihood of introduction and is therefore 
covered by the requirements in the systems approach.

Comments on the Systems Approach

    We proposed to require the NPPO of China to provide an operational 
workplan to APHIS that details the activities that the NPPO would, 
subject to APHIS' approval of the workplan, carry out to meet the 
requirements of the regulations. An operational workplan is an 
agreement between PPQ, officials of the NPPO of a foreign government, 
and, when necessary, foreign commercial entities that specifies in 
detail the phytosanitary measures that will comply with our regulations 
governing the import or export of a specific commodity. Operational 
workplans establish detailed procedures and guidance for the day-to-day 
operations of specific import/export programs. 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. Two commenters stated that since 
the operational workplan, in particular the section on required 
production practices, has not yet been approved by APHIS it was 
impossible to adequately evaluate the risks of the proposal. Another 
commenter asked us to present details of the operational workplan.
    Generally speaking, APHIS does not finalize an operational workplan 
until after the rule itself is finalized given that changes may be made 
to the rule as a result of public comment. However, given the 
similarity of the systems approaches, we anticipate that the 
operational workplan associated with the importation of apples from 
China will be very similar to the workplan for the importation of pears 
from China, which has been used to mitigate risk successfully for the 
past 15 years. This will likely include such requirements as field 
inspection, orchard control, culling, and spraying with compressed air.
    We proposed to require that, when any apples destined for export to 
the continental United States are still on the tree and are no more 
than 2 centimeters in diameter, double-layered paper bags must be 
placed wholly over the apples.
    We are making a minor change to the requirements as they pertain to 
when the bags are placed as they were set out in the proposed rule. 
Instead of requiring that bags be placed over the apples when they are 
no more than 2 centimeters in diameter, we are requiring that the bags 
be placed over the apples when they are no more than 2.5 centimeters in 
diameter. The 2 centimeter diameter specified in the proposed rule was 
an error and the change to 2.5 centimeters is necessary to keep the 
regulations in line with bagging protocols for pears from China. The 
change from 2 centimeters to 2.5 centimeters will have no effect on the 
phytosanitary safety of the young apple fruit. At this stage in the 
fruit's growth any attacks made by surface feeding or internally 
feeding pests will lead to visible deformation of the fruit and to 
fruit drop. Further, an increase of 0.5 centimeters in fruit diameter 
at this stage represents generally a week's worth of growth, which is 
insufficient time for any widespread infestation of young fruit to 
occur.
    Two commenters asked which studies confirm APHIS's assertion that 
bagging the fruit will mitigate all the pests of concern discussed in 
the PRA. Another commenter wanted to know whether APHIS can prove the 
effectiveness of fruit bagging as a phytosanitary mitigation based on 
the volume of apples that will likely be shipped. Another commenter 
pointed out that we had modeled the bagging protocol on a similar 
protocol for the importation of pears from China, and that pears 
imported under this protocol had sometimes been determined to be 
infested with plant pests. The commenter stated that this calls into 
question the efficacy of this mitigation.
    We did not claim that the required bagging will serve as sole 
mitigation for the pests of concern listed in the PRA. The entire 
systems approach, which comprises a number of requirements working in 
concert, will provide that mitigation. While we do not possess

[[Page 22631]]

evidence regarding the efficacy of bagging for apples in particular, 
the efficacy of bagging as a means of preventing fruit from becoming 
infested with quarantine insects is well established: The RMD cited 
several peer-reviewed studies regarding its efficacy. Additionally, we 
note that bagging is a pest-exclusionary technique that is similar to 
safeguarding with mesh, tarps, containment structures, and other 
mitigations APHIS has relied on to prevent pests from following the 
pathway of fruits for many years.
    Fruit bagging has been a required aspect of the systems approach 
for the importation of pears from China for the past 15 years. This 
program experiences an extremely low interception rate--15 
interceptions in 15 years--with an import volume of about 10,000 MT 
annually. Although it is not possible to say with absolute certainty, 
given the structure and past behavior of the Chinese apple industry, 
which is discussed in detail in the final regulatory flexibility 
analysis, we expect apples to be imported at a similar rate. Contrary 
to the third commenter's claim that 15 pest interceptions over a 15-
year period is troubling, given the time period in question and the 
level of imports during that time, this interception rate does not call 
into question the efficacy of bagging, but rather underscores its 
efficacy.
    We proposed to require the NPPO of China to visit and inspect 
registered places of production prior to harvest for signs of 
infestations. One commenter stated that the required interval for 
inspection was insufficient and would not serve to ensure compliance. 
Two commenters said that the required inspection frequency was also 
inadequate to enforce the requirement for removal of fallen fruit at 
the place of production.
    As stated in the proposed rule, this provision is modeled on an 
existing provision that has been successfully employed as part of the 
systems approach that used by APHIS for the importation of fragrant 
pears and sand pears from China. Given our knowledge and experience 
with the importation of these pears, we are confident that the 
requirement is adequate. In addition, as with any regulatory program, 
unannounced inspections and spot checks are often used to ensure 
compliance. Suspension or expulsion from the export program would also 
serve to discourage noncompliance. Our approach to any required orchard 
procedures, such as the removal of fallen fruit, would be the same.
    We proposed to set forth requirements for mitigation measures that 
would have to take place at registered packinghouses. These measures 
include a requirement that during the time registered packinghouses are 
in use for packing apples for export to the continental United States, 
the packinghouses may only accept apples that are from registered 
places of production and that are produced in accordance with the 
regulations, tracking and traceback capabilities, establishment of a 
handling procedure (e.g., culling damaged apples, removing leaves from 
the apples, wiping the apples with a clean cloth, air blasting, or 
grading) for the apples that is mutually agreed upon by APHIS and the 
NPPO of China, washing, brushing, spraying with compressed air, and box 
marking. A commenter said that the inspection procedures for 
packinghouses do not provide sufficient detail. The commenter said that 
packinghouse inspections must adequately ensure that leaf removal and 
washing of apples are conducted according to applicable requirements 
and added that the packinghouse must address the risk associated with 
apples originating from nonregistered places of production that may 
have been processed ahead of the packaging of the apples destined for 
U.S. markets. Several commenters stated that we should require that 
Chinese packinghouses handling apples intended for export to the United 
States not accept commodities destined for any other markets given that 
the phytosanitary standards required to access non-U.S. markets may be 
weaker. Another commenter pointed out that the size of the required 
biometric sample was unspecified. Another commenter stated that 
packinghouse culling and inspection do not eliminate all lepidopteran 
and curculionid pests in the United States, so APHIS should not assume 
that they will do so in China.
    As stated previously, APHIS inspectors have the authority to reject 
consignments that contain contaminants such as leaves and other plant 
debris, especially if any pests are found to be generally infesting 
that shipment. As stipulated in Sec.  319.56-3(a), ``All fruits and 
vegetables imported under this subpart, whether in commercial or 
noncommercial consignments, must be free from plant litter or debris 
and free of any portions of plants that are specifically prohibited in 
the regulations in this subpart.'' Washing of apples will be required 
under the regulations, with specific washing procedures set out in the 
operational workplan. We will also stipulate that packinghouses may not 
be used for packing apples from non-registered places of production 
simultaneous to packing apples from registered places of production. 
Requiring a facility be dedicated for shipping only to the United 
States is not technically justified if that facility can demonstrate 
and practice effective methods for identifying and segregating fruit 
destined for different markets.
    The specifics of packinghouse inspection procedures are listed in 
the operational workplan in order to offer the greatest amount of 
flexibility in responding to any rapidly changing pest issues that may 
arise. Typically APHIS will require at least 300 fruit be inspected, a 
number that will detect a 1 percent or greater pest population with 95 
percent confidence. APHIS will also require that a portion of the fruit 
be cut open to look for internally feeding pests. Any fruit with damage 
or signs of pest presence will be sampled first.
    We disagree with the commenter's assessment of the presence of 
lepidopteran and curculionid pests in the United States post culling 
and inspection. The commenter did not provide any support for the claim 
that these pests are evading domestic phytosanitary measures.
    One commenter said that, while box labeling and traceback 
information are vital to prevent the further spread of any plant pest, 
this information alone does not prevent the establishment of the pest 
in the United States.
    We agree. However, box labeling and traceback are only one aspect 
of the required systems approach for the importation of apples from 
China. The systems approach must be considered as a whole with its 
combined effect of various mitigation measures in order that its pest 
mitigation capabilities be fully assessed. We are confident that it 
will prove effective.
    We proposed to require treatment of fumigation plus refrigeration 
for those apples grown south of the 33rd parallel, since Oriental fruit 
fly is known to exist, in varying population densities, in that region. 
One commenter stated that it is possible that a mutated gene may 
eventually allow a number of Oriental fruit flies to resist fumigation.
    If Oriental fruit flies were to become resistant to the designated 
phytosanitary treatment, the import program would be shut down 
completely until an investigation has been completed and the reason for 
the program failure resolved.
    Several commenters stated that we should require that Chinese cold 
storage facilities housing apples intended for export to the United 
States not accept commodities destined for any other

[[Page 22632]]

markets given that the phytosanitary standards required to access non-
U.S. markets may be weaker.
    Requiring a facility be dedicated for shipping only to the United 
States is not technically justified if that facility can demonstrate 
and practice effective methods for identifying and segregating fruit 
destined for different markets.

Comments on the Economic Analysis

    We prepared an initial regulatory flexibility analysis in 
connection with the proposed rule regarding the economic effects of the 
rule on small entities. We invited comments on any potential economic 
effects and received a number of comments. Those comments are discussed 
and responded to in detail in the final regulatory flexibility analysis 
associated with this final rule. Copies of the full analysis are 
available on the Regulations.gov Web site (see footnote 1 in this 
document for a link to Regulations.gov) or by contacting the person 
listed under FOR FURTHER INFORMATION CONTACT.

Comments on General Economic Effects

    While specific comments on the initial regulatory flexibility 
analysis are addressed in the final regulatory flexibility analysis as 
previously stated, we received a number of comments concerning the 
overall economic effect of the rule as it relates to U.S. trade 
policies concerning China that are more appropriately addressed here.
    One commenter stated that APHIS did not meet those requirements of 
Executive Order 13563 that specify that agencies must take into account 
the benefits and costs, both qualitative and quantitative, of the rules 
they promulgate. The commenter specifically said that APHIS had failed 
to demonstrate that the proposed rule provided any benefit to U.S. 
consumers and stakeholders.
    We disagree with the commenter's assessment. Executive Order 13563 
requires that agencies propose or adopt a regulation upon a reasoned 
determination that its benefits justify its costs (recognizing that 
some benefits and costs are difficult to quantify). The Executive Order 
also states that, where appropriate and permitted by law, each agency 
may consider (and discuss qualitatively) values that are difficult or 
impossible to quantify, including equity, human dignity, fairness, and 
distributive impacts. The Executive Order ultimately leaves the type of 
analysis to the discretion of the Agency. We have previously explained 
the reasons for which APHIS conducts qualitative rather than 
quantitative analyses.
    As detailed in the initial regulatory flexibility analysis that 
accompanied the proposed rule and restated in the final regulatory 
flexibility analysis associated with this rule, we find it unlikely 
that the importation of apples from China will represent a cost to the 
U.S. apple industry or to U.S. consumers. This is due to the relatively 
small amount of apples that are expected to be exported and qualitative 
factors associated with consumer demand such as variety, flavor (acids, 
sugars, aroma), juiciness, crispness, firmness, appearance (color, 
shape and size), freshness, perceived health benefits, production 
method (organic or conventional), and product origin (local, regional, 
domestic or import). Moreover, trade with China represents an 
opportunity for potential expansion of the U.S. export market and the 
benefits associated with such an expansion.
    One commenter claimed that China is not an open market for fair 
trade and, as a result, efforts to market U.S. apples in China in 
return for allowing Chinese apples access to U.S. markets will prove 
unsuccessful. Another commenter said that, in the past, China claimed 
that U.S. apples presented unacceptable phytosanitary risk and 
subsequently halted all importation of apples from the United States 
into China. The commenter stated that this was done without 
substantiated claims or investigation as a tactic to force the United 
States to open its markets to Chinese apples.
    We disagree with the claim that China's prohibition on the 
importation of apples from the United States was without basis and was 
motivated by bilateral trade concerns. In 2012, the NPPO of China 
suspended access for red and golden delicious apples from the State of 
Washington due to repeated interceptions of three apple pests the NPPO 
considers significant: Speck rot (caused by Phacidiopycnis 
washingtonensis), bull's-eye rot (caused by four species of 
Neofabraea), and Sphaeropsis rot (caused by Sphaeropsis 
pyriputrescens). In response, APHIS worked with the U.S. apple industry 
to develop additional safeguarding measures to address China's concerns 
about these pests. As a result, red and golden delicious apples were 
permitted to be imported from the United States into China beginning in 
early November 2014.
    Another commenter stated that Chinese import competition affects 
local labor markets by triggering declines in associated wages and 
employment.
    While APHIS is sensitive to the costs its actions may impose on 
producers in the United States, as detailed in the final regulatory 
flexibility analysis, apples are not inexpensive to produce in China 
due, in large part, to differences between the way the apple industry 
is structured in the United States and China. Most apple growers in 
China operate on a very small scale and production is labor-intensive, 
requiring significant labor resources to plant, tend, and harvest the 
crop.
    One commenter urged APHIS to support and encourage consumers in 
doing business with local farmers. The commenter claimed that the low 
price of Chinese apples would cause domestic producers economic 
distress.
    We would observe that consumer practices when purchasing fresh 
apples are influenced by factors other than price. These factors 
include variety, size, color, flavor, texture, freshness, product 
origin, and production method. American consumers benefit from a 
diverse and abundant supply of fresh apples that are locally, 
regionally, and nationally distributed to them; it is highly unlikely 
that China will become a dominant supplier.

Comments on Bilateral Trade

    Several commenters pointed out that access to Chinese markets for 
U.S. apples is not currently assured at this point in time. The 
commenters asked that APHIS make sure that the proposed rule would not 
be finalized before reciprocal market access is granted. One of the 
commenters added that, if Chinese apples were able to be imported into 
the United States, but U.S. apples could not be exported to China, then 
the underlying assumptions concerning the economic impact of the 
importation of apples from China would prove incorrect. Another 
commenter stated that, if China were to allow for the importation of 
apples from the United States, there is concern that small American 
producers will not be able to make such market access opportunities 
profitable. Another commenter suggested that APHIS regulate the amount 
and variety of apples allowed into the United States from China.
    Other countries make decisions as to whether to allow the 
importation of U.S. products only when formally requested. APHIS 
formally requested that China allow the importation of U.S. apples, and 
we worked with the U.S. apple industry to address concerns raised by 
the NPPO of China, resulting in the successful reopening of the Chinese 
apple market to U.S. apple growers in November 2014. However, APHIS' 
primary responsibility with regard to international import trade is 
now, and has been for many years, to identify and manage the 
phytosanitary risks

[[Page 22633]]

associated with importing commodities. When we determine that the risk 
associated with the importation of a commodity can be successfully 
mitigated, it is our responsibility under the trade agreements to which 
we are signatory to make provisions for the importation of that 
commodity. Moreover, under the PPA, our decisionmaking related to 
allowing or denying the importation of commodities must be based on 
phytosanitary considerations rather than the goal of reciprocal market 
access.
    Another commenter stated that the PPA requires that APHIS base its 
regulations on sound science and that the desire for reciprocal apple 
trade with China is not science-based. The commenter said that if hope 
of such mutual access was influential in the development of the 
proposed rule, then the rule is not compliant with the PPA, and 
therefore illegal. The same commenter also stated that such a situation 
violates the conditions of the SPS Agreement, particularly Article 2.2, 
which requires that signatories base sanitary and phytosanitary 
regulations on scientific principles, and Article 5.1, which requires 
that signatories base their actions on a risk assessment. The commenter 
reiterates that reciprocal trade is neither a scientific principle nor 
a risk assessment and APHIS's proposed action may therefore be out of 
compliance with the SPS Agreement.
    This action was predicated on several risk assessment documents 
that provide a scientific basis for potential importation of apples 
from China. Without these risk assessment documents, which have 
withstood several reviews and public comment periods, APHIS would not 
have proposed this action. Political and economic interests may 
stimulate consideration of the expansion of trade of agricultural 
commodities between countries, but all decisionmaking concerning 
phytosanitary restrictions on trade must be science-based. APHIS stands 
behind the risk assessment documents that support this rule, and 
believes they are based on sound science.
    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 5 U.S.C. 604, we have performed a final 
regulatory flexibility analysis, which is summarized below, regarding 
the economic effects of this rule on small entities. Copies of the full 
analysis are available on the Regulations.gov Web site (see footnote 1 
in this document for a link to Regulations.gov) or by contacting the 
person listed under FOR FURTHER INFORMATION CONTACT.
    Apples are the second most popular fresh fruit for U.S. consumers 
and the third most valuable fruit crop produced in the United States. 
The United States is the world's second largest apple producer and 
became the world's largest apple exporter in terms of value in 2012, 
generating a surplus of $909 million in fresh apple trade (exports 
minus imports). That year, the United States commercially produced 4.1 
million metric tons (MT) of apples, valued at $3 billion, of which 3 
million MT of apples were sold fresh and 1.1 million MT were used for 
processing. Although apples are commercially grown in all 50 States, 9 
States accounted for 96 percent of production. The State of Washington 
was by far the largest producer, at more than 2.9 million MT per year 
(over 70 percent of the U.S. total).
    Almost all apple farms are family-owned, and many of these families 
have been engaged in apple production for many generations. The U.S. 
apple industry is challenged by relatively flat domestic apple 
consumption, and its continued growth relies on expanded global trade. 
Roughly 30 percent of fresh apples produced in the United States were 
exported in 2012. That year, roughly 8 percent of fresh apples consumed 
in the United States were imported, totaling 183,000 MT and valued at 
$164 million. Virtually all imports came from four trading partners: 
Chile, New Zealand, Canada, and Argentina.
    By quantity, China was the world's largest producer, consumer and 
exporter of apples in 2012. (In 2013, Poland became the world's largest 
exporter of apples in quantity, whereas the United States remained the 
world's largest exporter of apples in value). Apples are the leading 
fruit produced in China, with production having increased from 2.3 
million MT in 1978, to 38.5 million MT (33.3 million MT for fresh 
markets and 5.2 million MT for processing) in 2012. China's apple 
consumption has grown to 37.5 million MT.
    In contrast to that of the United States, China's apple industry 
relies marginally on international trade--in 2012, it exported about 3 
percent of fresh apples produced and imported 0.1 percent of fresh 
apples consumed. China's exports of fresh apples peaked in 2009 at 1.2 
million MT and declined to 0.98 million MT in 2012. Most of the 4.3 
million apple growers in China operate on a small scale, with farm 
acreages averaging 1.3 acres. The Fuji variety accounts for about 70 
percent of China's apple production. China's heavy dependence on the 
Fuji variety is in sharp contrast to the many diverse varieties 
produced in the United States. China's export markets are concentrated 
in Russia, Southeast Asia, and the Middle East. Chinese fresh apples 
also have been exported for more than a decade to Canada; however, 
Canada accounted only for 0.4 percent of China's fresh apple exports in 
2012. In fact, China's combined export volume to Canada, European Union 
(EU) member countries, Australia, and Mexico is very small (0.8 percent 
of its total fresh apple exports in 2012), and has significantly 
declined in the last 6 years, from 45,267 MT in 2007 (4.4 percent of 
Chinese apple exports) to 8,273 MT in 2012. Average export prices of 
fresh apples from China in 2012 to the aforementioned countries 
(Canada, $1.50/kilogram (kg); EU, $1.10/kg; Australia, $1.83/kg; and 
Mexico, $1.55/kg) are consistently higher than the average price paid 
in all 67 countries to which China exported fresh apples ($0.98/kg). It 
is reasonable to expect that price for fresh apples exported to the 
United States will be similar to prices paid in Canada and Mexico. 
Considering the current availability of relatively low-priced imported 
apples in the United States and the wide range of domestic varieties, 
apples imported from China are not likely to compete solely on price in 
the U.S. market. U.S. consumers make their purchasing decisions for 
fresh apples based not only on price, but also on intrinsic product 
attributes such as variety, color, size, flavor, texture, freshness, 
production method, and product origin.
    Based on historic data of China's apple production, consumption, 
export volumes, and prices, we expect no more than 10,000 MT of fresh 
apples will be imported from China into the continental United States 
annually, which represents less than 0.44 percent of the U.S. domestic 
fresh apple supply and less than 5 percent of U.S. imports in 2012. 
Most of China's fresh apple exports to the United States will likely be 
shipped to West Coast ports, primarily ones in California, and are 
expected to be distributed through Asian ethnic supermarkets mainly to 
Asian communities.
    California is the largest market for Washington State apples; any 
effects of the rule may be borne mainly by

[[Page 22634]]

Washington and California apple growers. In particular, U.S. apple 
growers of the Fuji variety, which comprised about 8 percent of U.S. 
production in 2011, may be more directly affected by an increase in 
supply because we expect the majority of fresh apples from China will 
be of the Fuji variety. However, given the relatively small quantity 
expected to be imported from China, any negative impacts for U.S. small 
entities will not be significant.

Executive Order 12988

    This final rule allows apples to be imported into the continental 
United States from China. State and local laws and regulations 
regarding apples 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 0579-0423, 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 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 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 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. Section 319.56-72 is added to read as follows:

Sec.  319.56-72  Apples from China.

    Fresh apples (Malus pumila) from China may be imported into the 
continental United States from China only under the conditions 
described in this section. These conditions are designed to prevent the 
introduction of the following quarantine pests: Adoxophyes orana 
(Fischer von R[ouml]slerstamm), summer fruit tortix; Archips micaceana 
(Walker), a moth; Argyrotaenia ljungiana (Thunberg), grape tortix; 
Bactrocera dorsalis (Hendel), Oriental fruit fly; Carposina sasakii 
Matsumura, peach fruit moth; Cenopalpus pulcher (Canestrini & Fanzago), 
flat scarlet mite; Cryptoblabes gnidiella (Milli[egrave]re), honeydew 
moth; Cydia funebrana (Treitschke), plum fruit moth; Euzophera bigella 
(Zeller), quince moth; Euzophera pyriella Yang, a moth; Grapholita 
inopinata Heinrich, Manchurian fruit moth; Leucoptera malifoliella 
(Costa), apple leaf miner; Monilia polystroma van Leeuwen, Asian brown 
rot; Monilinia fructigena Honey, brown fruit rot; Rhynchites auratus 
(Scopoli), apricot weevil; Rhynchites bacchus (L.), peach weevil; 
Rhynchites giganteus Krynicky, a weevil; Rhynchites heros Roelofs, a 
weevil; Spilonota albicana (Motschulsky), white fruit moth; Spilonota 
prognathana Snellen, a moth; and Ulodemis trigrapha Meyrick, a moth. 
The conditions for importation of all fresh apples from China are found 
in paragraphs (a) through (e) of this section; additional conditions 
for apples imported from areas of China south of the 33rd parallel are 
found in paragraph (f) of this section.
    (a) General requirements. (1) The national plant protection 
organization (NPPO) of China must provide an operational workplan to 
APHIS that details the activities that the NPPO of China will, subject 
to APHIS' approval of the workplan, carry out to meet the requirements 
of this section.
    (2) The apples must be grown at places of production that are 
registered with the NPPO of China.
    (3) Apples from China may be imported in commercial consignments 
only.
    (b) Place of production requirements. (1) The place of production 
must carry out any phytosanitary measures specified for the place of 
production under the operational workplan as described in the 
regulations.
    (2) When any apples destined for export to the continental United 
States are still on the tree and are no more than 2.5 centimeters in 
diameter, double-layered paper bags must be placed wholly over the 
apples. The bags must remain intact and on the apples until at least 14 
days prior to harvest.
    (3) The NPPO of China must visit and inspect registered places of 
production prior to harvest for signs of infestation and/or infection.
    (4) If Monilia polystroma van Leeuwen or Monilinia fructigena is 
detected at a registered place of production, APHIS may reject the 
consignment or prohibit the importation into the continental United 
States of apples from the place of production for the remainder of the 
season. The exportation to the continental United States of apples from 
the place of production may resume in the next growing season if an 
investigation is conducted by the NPPO, and APHIS and the NPPO conclude 
that appropriate remedial action has been taken.
    (c) Packinghouse requirements. (1) Packinghouses must be registered 
with the NPPO of China, and during the time registered packinghouses 
are in use for packing apples for export to the continental United 
States, the packinghouses may only accept apples that are from 
registered places of production and that are produced in accordance 
with the requirements of this section.
    (2) Packinghouses must have a tracking system in place to readily 
identify all apples destined for export to the continental United 
States that enter the packinghouse and be able to trace the apples back 
to their place of production.
    (3) Following the packinghouse inspection, the packinghouse must 
follow a handling procedure for the apples that is mutually agreed upon 
by APHIS and the NPPO of China.
    (4) The apples must be washed and brushed as well as waxed or 
sprayed with compressed air prior to shipment.
    (5) The apples must be packed in cartons that are labeled with the 
identity of the place of production and the packinghouse.

[[Page 22635]]

    (d) Shipping requirements. Sealed containers of apples destined for 
export to the continental United States must be held in a cold storage 
facility while awaiting export.
    (e) Phytosanitary certificate. Each consignment of apples imported 
from China into the continental United States must be accompanied by a 
phytosanitary certificate issued by the NPPO of China with an 
additional declaration stating that the requirements of this section 
have been met and the consignment has been inspected by the NPPO and 
found free of quarantine pests.
    (f) Additional conditions for apples from areas of China south of 
the 33rd parallel. In addition to the conditions in paragraphs (a) 
through (e) of this section, apples from areas of China south of the 
33rd parallel apples must be treated in accordance with 7 CFR part 305. 
(Approved by the Office of Management and Budget under control number 
0579-0423)

    Done in Washington, DC, this 20th day of April 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-09508 Filed 4-22-15; 8:45 am]
 BILLING CODE 3410-34-P
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