[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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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.
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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.
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\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.
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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.
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\2\ You may view the data sheet on the Internet at https://www.eppo.int/QUARANTINE/insects/Carposina_sasakii/CARSSA_ds.pdf.
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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.
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\3\ You may sign up for the PPQ Stakeholder Registry on the
Internet at https://public.govdelivery.com/accounts/USDAAPHIS/subscriber/new/.
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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).
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\4\ You may view the paper on the Internet at http://bioline.org.br/pdf?hn06022.
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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.
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\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.
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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