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contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

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REGISTER issue of each week.

Rules and Regulations Federal Register

22619 

Vol. 80, No. 78 

Thursday, April 23, 2015 

1To view the proposed rule, its supporting 

documents, or the comments that we received, go 

to http://www.regulations.gov/

#!docketDetail;D=APHIS-2014-0003. 

DEPARTMENT OF AGRICULTURE 

Animal and Plant Health Inspection 

Service 

7 CFR Part 319 

[Docket No. APHIS–2014–0003] 

RIN 0579–AD89 

Importation of Apples From China 

AGENCY: Animal and Plant Health 

Inspection Service, USDA. 

ACTION: Final rule. 

SUMMARY: We are amending the fruits 

and vegetables regulations to allow the 

importation of fresh apples (Malus 

pumila) from China into the continental 

United States. As a condition of entry, 

apples from areas in China in which the 

Oriental fruit fly (Bactrocera dorsalis) is 

not known to exist will have to be 

produced in accordance with a systems 

approach that includes requirements for 

registration of places of production and 

packinghouses, inspection for 

quarantine pests at set intervals by the 

national plant protection organization of 

China, bagging of fruit, safeguarding, 

labeling, and importation in commercial 

consignments. Apples from areas in 

China in which Oriental fruit fly is 

known to exist may be imported into the 

continental United States if, in addition 

to these requirements, the apples are 

treated with fumigation plus 

refrigeration. All apples from China will 

also be required to be accompanied by 

a phytosanitary certificate with an 

additional declaration stating that all 

conditions for the importation of the 

apples have been met and that the 

consignment of apples has been 

inspected and found free of quarantine 

pests. This action allows for the 

importation of apples from China into 

the continental United States while 

continuing to provide protection against 

the introduction of quarantine pests. 

DATES: Effective May 26, 2015. 

FOR FURTHER INFORMATION CONTACT: Mr. 

David B. Lamb, Senior Regulatory 

Policy Specialist, RPM, PPQ, APHIS, 

4700 River Road Unit 133, Riverdale, 

MD 20737–1231; (301) 851–2018. 

SUPPLEMENTARY INFORMATION: 

Background 

The regulations in ‘‘Subpart—Fruits 

and Vegetables’’ (7 CFR 319.56–1 

through 319.56–71, referred to below as 

the regulations) prohibit or restrict the 

importation of fruits and vegetables into 

the United States from certain parts of 

the world to prevent the introduction 

and dissemination of plant pests that are 

new to or not widely distributed within 

the United States. 

The national plant protection 

organization (NPPO) of China has 

requested that the Animal and Plant 

Health Inspection Service (APHIS) 

amend the regulations to allow apples 

(Malus pumila) from China to be 

imported into the continental United 

States. 

In response to that request, we 

prepared a pest risk assessment (PRA) 

and a risk management document 

(RMD). Based on the conclusions of the 

PRA and the RMD, on July 18, 2014, we 

published in the Federal Register (79 

FR 41930–41934, Docket No. APHIS– 

2014–0003) a proposal 1 to amend the 

regulations to authorize the importation 

of fresh apples into the continental 

United States, provided that the apples 

were produced in accordance with a 

systems approach consisting of the 

following requirements: Production by a 

grower who is part of a certification 

program administered by the NPPO of 

China; fruit bagging; pre-harvest NPPO 

inspection; packing in packinghouses 

that are registered with the NPPO; 

packinghouse procedures including 

traceback and box marking; post-harvest 

washing; waxing; treatment with 

inspection after packing for quarantine 

pests; issuance of a phytosanitary 

certificate; importation in commercial 

consignments only; sealed boxes; and 

location of apples in a cold storage 

facility while awaiting export to the 

continental United States. For apples 

from those areas of China south of the 

33rd parallel, where the Oriental fruit 

fly (Bactrocera dorsalis) is known to 

exist, we proposed to require treatment 

in accordance with 7 CFR 305.2, which 

provides that approved treatment 

schedules are set out in the Plant 

Protection and Quarantine (PPQ) 

Treatment Manual, found online at 

http://www.aphis.usda.gov/import_

export/plants/manuals/ports/

downloads/treatment.pdf. 

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 


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22620 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

2 You may view the data sheet on the Internet at 

https://www.eppo.int/QUARANTINE/insects/

Carposina_sasakii/CARSSA_ds.pdf. 

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. 

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 

§ 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 


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Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 22621 

3 You may sign up for the PPQ Stakeholder 

Registry on the Internet at https://

public.govdelivery.com/accounts/USDAAPHIS/

subscriber/new/. 

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. 

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. 


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22622 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

4 You may view the paper on the Internet at 

http://bioline.org.br/pdf?hn06022. 

5The 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. 

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 § 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). 

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. 

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, 


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


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22624 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

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 insectinfested. 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. 


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

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 § 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 § 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 incountry 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 

Ro ̈ slerstamm), summer fruit tortix. 

• Archips micaceana (Walker), a 

moth. 

• Argyrotaenia ljungiana (Thunberg), 

grape tortix. 


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22626 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

• Bactrocera dorsalis (Hendel), 

Oriental fruit fly. 

• Carposina sasakii Matsumura, 

peach fruit moth. 

• Cenopalpus pulcher (Canestrini & 

Fanzago), flat scarlet mite. 

• Cryptoblabes gnidiella (Millie`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, § 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 § 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. 


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


rljohnson on DSK7TPTVN1PROD with RULES
22628 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

6Copies of the full analysis are available by 

contacting the person listed under FOR FURTHER

INFORMATION CONTACT. 

7That 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. 

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. 

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. 

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 


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


rljohnson on DSK7TPTVN1PROD with RULES
22630 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

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 


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


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22632 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

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 


rljohnson on DSK7TPTVN1PROD with RULES
Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 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 familyowned, 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 


rljohnson on DSK7TPTVN1PROD with RULES
22634 Federal Register / Vol. 80, No. 78 / Thursday, April 23, 2015 / Rules and Regulations 

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 caseby-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 

■ 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. 

■ 2. Section 319.56–72 is added to read 

as follows: 

§ 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 

Ro ̈ 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 (Millie`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, doublelayered 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. 


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

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2015–0830; Directorate 

Identifier 2015–NM–024–AD; Amendment 

39–18141; AD 2015–08–05] 

RIN 2120–AA64 

Airworthiness Directives; Dassault 

Aviation Airplanes 

AGENCY: Federal Aviation 

Administration (FAA), Department of 

Transportation (DOT). 

ACTION: Final rule; request for 

comments. 

SUMMARY: We are superseding 

Airworthiness Directive (AD) 2013–26– 

05 for all Dassault Aviation Model FAN 

JET FALCON, FAN JET FALCON 

SERIES C, D, E, F, and G airplanes; 

Model MYSTERE–FALCON 200 

airplanes; and Model MYSTERE– 

FALCON 20–C5, 20–D5, 20–E5, and 20– 

F5 airplanes. AD 2013–26–05 required 

repetitive weighing of fire extinguisher 

bottles having a certain part number, 

and eventual replacement of those 

bottles to terminate the repetitive 

weighing. This new AD continues to 

require repetitive weighing of fire 

extinguisher bottles having a certain 

part number, and eventual replacement 

of those bottles to terminate the 

repetitive weighing. This AD was 

prompted by our determination that 

certain text in the method of compliance 

language specified in AD 2013–26–05 

incorrectly refers to Airbus, instead of 

‘‘Dassault Aviation.’’ We are issuing this 

AD to detect and correct a dormant 

failure in the fire suppression system, 

which could result in the inability to 

put out a fire in an engine, auxiliary 

power unit (APU), or rear compartment. 

DATES: This AD becomes effective May 

8, 2015. 

The Director of the Federal Register 

approved the incorporation by reference 

of certain other publications listed in 

this AD as of October 20, 2014 (79 FR 

54897, dated September 15, 2014). 

We must receive comments on this 

AD by June 8, 2015. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M– 

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue SE., 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. 

For service information identified in 

this AD, contact Dassault Falcon Jet, 

P.O. Box 2000, South Hackensack, NJ 

07606; telephone 201–440–6700; 

Internet http://www.dassaultfalcon.com. 

You may view this referenced service 

information at the FAA, Transport 

Airplane Directorate, 1601 Lind Avenue 

SW., Renton, WA. For information on 

the availability of this material at the 

FAA, call 425–227–1221. 

Examining the AD Docket 

You may examine the AD docket on 

the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0830; or in person at the Docket 

Operations office between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. The AD docket 

contains this AD, the regulatory 

evaluation, any comments received, and 

other information. The street address for 

the Docket Operations office (telephone 

800–647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: Tom 

Rodriguez, Aerospace Engineer, 

International Branch, ANM–116, 

Transport Airplane Directorate, FAA, 

1601 Lind Avenue SW., Renton, WA 

98057–3356; telephone 425–227–1137; 

fax 425–227–1149. 

SUPPLEMENTARY INFORMATION: 

Discussion 

On August 29, 2014, we issued AD 

2013–26–05, Amendment 39–17714 (79 

FR 54897, September 15, 2014), which 

applied to all Dassault Aviation Model 

FAN JET FALCON, FAN JET FALCON 

SERIES C, D, E, F, and G airplanes; 

Model MYSTERE–FALCON 200 

airplanes; and Model MYSTERE– 

FALCON 20–C5, 20–D5, 20–E5, and 20– 

F5 airplanes. AD 2013–26–05 was 

prompted by reports of a manufacturing 

defect in the charge indicator on fire 

extinguisher bottles. AD 2013–26–05 

required repetitive weighing of fire 

extinguisher bottles having a certain 

part number, and eventual replacement 

of those bottles to terminate the 

repetitive weighing. We issued AD 

2013–26–05 to detect and correct a 

dormant failure in the fire suppression 

system, which could result in the 

inability to put out a fire in an engine, 

APU, or rear compartment. 

AD 2013–26–05, Amendment 39– 

17714 (79 FR 54897, September 15, 

2014), corresponds to Mandatory 

Continuing Airworthiness Information 

(MCAI) European Aviation Safety 

Agency (EASA) AD 2012–0189, dated 

September 24, 2012. You may examine 

the MCAI on the Internet at http://

www.regulations.gov by searching for 

and locating Docket No. FAA–2015– 

0830. 

Since we issued AD 2013–26–05, 

Amendment 39–17714 (79 FR 54897, 

September 15, 2014), we have 

determined that there is an error in the 

manufacturer’s name in the method of 

compliance language in certain text in 

the ‘‘Explanation of Change Made to 

This AD’’ section and in certain 

paragraphs of the regulatory text of AD 

2013–26–05. AD 2013–26–05 refers to 

Airbus’s EASA Design Organization 

Approval (DOA), instead of Dassault 

Aviation’s EASA DOA. In order to refer 

to the appropriate EASA DOA, this AD 

replaces ‘‘Airbus’s’’ with ‘‘Dassault 

Aviation’s’’ in paragraphs (h)(2), 

(h)(2)(i), (h)(2)(ii), (h)(2)(iii), (h)(2)(iv), 

(i), (i)(1), (i)(2), (i)(3), (i)(4), (j)(1), (j)(2), 

(j)(3), (j)(4), and (l)(2) of this AD. The 

‘‘Explanation of Change Made to This 

AD’’ section of AD 2013–26–05 is not 

restated in this AD. 


rljohnson on DSK7TPTVN1PROD with RULES