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Rules and Regulations Federal Register Vol. 80, No. 78

Thursday, April 23, 2015

This section of the FEDERAL REGISTER DATES: Effective May 26, 2015. fly (Bactrocera dorsalis) is known to contains regulatory documents having general FOR FURTHER INFORMATION CONTACT: Mr. exist, we proposed to require treatment applicability and legal effect, most of which David B. Lamb, Senior Regulatory in accordance with 7 CFR 305.2, which are keyed to and codified in the Code of Policy Specialist, RPM, PPQ, APHIS, provides that approved treatment Federal Regulations, which is published under schedules are set out in the Plant 50 titles pursuant to 44 U.S.C. 1510. 4700 River Road Unit 133, Riverdale, MD 20737–1231; (301) 851–2018. Protection and Quarantine (PPQ) The Code of Federal Regulations is sold by SUPPLEMENTARY INFORMATION: Treatment Manual, found online at the Superintendent of Documents. Prices of http://www.aphis.usda.gov/import_ new books are listed in the first FEDERAL Background export/plants/manuals/ports/ REGISTER issue of each week. The regulations in ‘‘Subpart—Fruits downloads/treatment.pdf. and Vegetables’’ (7 CFR 319.56–1 We note that we are changing the through 319.56–71, referred to below as bagging protocol from that which was DEPARTMENT OF AGRICULTURE the regulations) prohibit or restrict the set out in the proposed rule. The importation of fruits and vegetables into proposed systems approach would have and Plant Health Inspection the United States from certain parts of required that bags remain on the fruit Service the world to prevent the introduction until its arrival at the packinghouse. In and dissemination of plant pests that are the final rule, we are requiring that the 7 CFR Part 319 new to or not widely distributed within bags stay on until at least 14 days prior [Docket No. APHIS–2014–0003] the United States. to harvest instead of remaining on the The national plant protection fruit until it reaches the packinghouse. RIN 0579–AD89 organization (NPPO) of has Though we modeled the systems requested that the Animal and Plant Importation of From China approach on a similar systems approach Health Inspection Service (APHIS) for the importation of from China, AGENCY: Animal and Plant Health amend the regulations to allow apples bag removal at this stage is a necessary Inspection Service, USDA. ( pumila) from China to be practice among growers in imported into the continental United ACTION: Final rule. countries where bagging protocols are States. employed as apples must be exposed to SUMMARY: We are amending the fruits In response to that request, we sunlight so that they may color up prior and vegetables regulations to allow the prepared a pest risk assessment (PRA) to harvest. Pears do not require similar importation of fresh apples (Malus and a risk management document treatment in order to achieve their pumila) from China into the continental (RMD). Based on the conclusions of the coloration. United States. As a condition of entry, PRA and the RMD, on July 18, 2014, we Bagging is an important mitigation; apples from areas in China in which the published in the Federal Register (79 however, we believe that removing the Oriental fruit fly (Bactrocera dorsalis) is FR 41930–41934, Docket No. APHIS– bags for the last 14 days before harvest 1 not known to exist will have to be 2014–0003) a proposal to amend the is unlikely to significantly increase the produced in accordance with a systems regulations to authorize the importation risk because bagging is only one approach that includes requirements for of fresh apples into the continental mitigation out of a number that are part registration of places of production and United States, provided that the apples of a systems approach. packinghouses, inspection for were produced in accordance with a Apples produced south of the 33rd quarantine pests at set intervals by the systems approach consisting of the parallel will require an APHIS-approved national plant protection organization of following requirements: Production by a treatment for Oriental fruit fly. China, bagging of fruit, safeguarding, grower who is part of a certification Specifically, this is fumigation plus labeling, and importation in commercial program administered by the NPPO of refrigeration. This treatment will consignments. Apples from areas in China; fruit bagging; pre-harvest NPPO effectively mitigate any pests that might China in which Oriental fruit fly is inspection; packing in packinghouses be present on the fruit after the removal known to exist may be imported into the that are registered with the NPPO; of the bags. continental United States if, in addition packinghouse procedures including Most, if not all, of the apple to these requirements, the apples are traceback and box marking; post-harvest production areas in China are north of treated with fumigation plus washing; waxing; treatment with the 33rd parallel. All of the refrigeration. All apples from China will inspection after packing for quarantine and Coleoptera listed in the PRA as also be required to be accompanied by pests; issuance of a phytosanitary following the pathway of fresh apples a phytosanitary certificate with an certificate; importation in commercial from China were assigned a medium additional declaration stating that all consignments only; sealed boxes; and risk of doing so. These pests are conditions for the importation of the location of apples in a cold storage mitigated by a number of other factors apples have been met and that the facility while awaiting export to the apart from bagging, including consignment of apples has been continental United States. For apples commercial production only, culling at inspected and found free of quarantine from those areas of China south of the the packinghouse, and the required pests. This action allows for the 33rd parallel, where the Oriental fruit inspection by the NPPO of China. importation of apples from China into APHIS does not expect this change to 1 To view the proposed rule, its supporting the continental United States while documents, or the comments that we received, go significantly increase the risk of pests continuing to provide protection against to http://www.regulations.gov/ from China apples. Growers will still be the introduction of quarantine pests. #!docketDetail;D=APHIS-2014-0003. responsible for maintaining low pest

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populations of target quarantine pests, after blossom drop and fruit set, the fruit necessary, APHIS can suspend with oversight by the NPPO of China will be protected by bags. production sites with pest interceptions and APHIS. These measures and others, The spp. may also attack until pest populations are mitigated. including removing fallen fruit, will the bark of the trees as well as fruit. We are also adding two post-harvest maintain low pest populations in the These pests build up in unmanaged and treatment requirements to those listed in production sites. The required culling backyard fruit trees. Well-managed the proposed rule. The RMD that will also remove pests from the production sites will rarely have accompanied the proposed rule required pathway. The biometric sampling rate infestations. apples to undergo washing and waxing. can be increased, if necessary, in order malifoliella, the leaf This procedure was included because to look for pests that may be present in blister , is a leaf mining species washing removes hitchhiking, casual, that is only found on the fruit if leaves smaller numbers in consignments, thus and surface pests associated with are attached to the fruit. Leaves and heightening the level of phytosanitary smooth-skinned fruit such as apples, other plant parts are prohibited, so the security. In addition, the bags will be and waxing also serves to eliminate risk of importing this pest with the fruit removed for 2 weeks in the fall, when many surface pests including is minimal. This pest is an external temperatures are rapidly declining Homoptera and mites. Washing and miner; any leaves or mines should be leading to winter and are prone waxing may also remove external spores readily detected and culled or found to reduced activity leading to dormancy. of plant pathogens. Some of the pests of concern during inspection. primarily attack the fruit early in the The eight species of , The two treatments we are adding in season when the fruit is at a small stage. ( orana, this final rule are fruit brushing and For example, the spp. adult micaceana, ljungiana, spraying with compressed air. Fruit attack small, newly formed fruit Cydia funebrana, Ulodemis trigrapha, brushing will be required as an in the spring and early summer and the Grapholita inopinata, additional packinghouse treatment eggs are laid in those fruit often causing albicana, and Spilonota prognathana) requirement, while spraying with fruit drop. The larvae develop in 3 or 4 are leaf rollers. They typically lay eggs compressed air will be an alternative to weeks after the eggs are laid and the on leaves and roll them up and feed on waxing. Brushing adds another level of larvae emerge from the fruit and pupate leaf tissue. When fruit are adjacent to phytosanitary protection against surface in the soil. There is only one generation leaves, the larvae may attack the fruit, pests and external spores and spraying per year. Infested fruit are misshapen usually leaving external feeding damage with compressed air serves the same with feeding damage and can easily be and sometimes boring into the fruit purpose as waxing in removing identified and culled. These pests are leaving visible holes and larval waste. hitchhiking, casual, and surface pests. very unlikely to be present in the fruit These species are unlikely to be present While brushing and spraying with in the fall when the bags are removed in any numbers during the fall and are compressed air are not widely used in 2 weeks before the apples are harvested, also expected to be controlled by fruit processing in the United States, and any infested, misshapen fruit would required pest management and standard these treatments are commonly used in be unlikely to be packed and can be agricultural best practices. This, the fruit packing industry in China and easily spotted upon inspection. combined with the small amount of other Asian countries. For example, in Some of the Lepidoptera species do time that the fruit will be exposed when § 319.56–65(c)(2), we require spraying not attack the fruit, and are only present the bags are removed, will greatly with compressed air as a treatment for on the fruit as contaminants, for reduce the possibility that these pineapples imported from Malaysia. example Cryptoblabes gnidiella Tortricidae will follow the pathway. In We solicited comments concerning primarily attacks fruit that has addition APHIS readily inspects for our proposal for 60 days ending infestations of Homoptera sp., which Tortricidae on many commodities. The September 16, 2014. We received 128 produce honey dew. Small larvae feed only time quarantine treatments are comments by that date. They were from on the honey dew and do not attack the required is when high populations and a national organization that represents fruit until they have grown to a larger frequent interceptions occur. APHIS U.S. apple producers, State departments stage. The larvae initially feed on the does not expect this, but removal of of agriculture, a State representative, surface of the fruit and do not bore into production sites in any problem areas scientific advisory groups, an the fruit. Based on the pest damage will allow APHIS to mitigate this risk environmental organization, domestic symptoms, inspection and culling will further. apple producers, and private citizens. As noted previously, the window for remove Lepidoptera pests from the The comments that we received are pest attack after the bags are removed is pathway. discussed below, by topic. sasakii larvae may bore very small (approximately 90 percent of General Comments on the Proposed into the fruit near the calyx, but the time after blossom drop and fruit Rule according to a 2014 data sheet from the set, the fruit will be protected by bags). European and Mediterranean Plant Attacks on the fruit by Lepidoptera and Curculionidae pests during this time are One commenter asked what sort of Protection Organization, ‘‘Infested outreach APHIS had conducted to apples exude a sticky gum, pears turn unlikely when these pest populations are kept in check by good pest publicize the availability of the yellow and apricots ripen unevenly.’’ 2 management and agricultural practices, proposed rule for comment. The These symptoms would allow any which has been our experience with commenter claimed that the number of infested fruit to be readily detected pears from China and we expect this to comments received suggested that during culling and inspections. The be true for apples. All of the Lepidoptera stakeholders and other interested parties window for the pests to attack after the and Curculionidae pests are borers into were unaware of its existence. bags are removed is also very small; for the fruit from eggs laid externally. We disagree with the commenter’s approximately 90 percent of the time Besides inspection for external assessment. As stated above, we received 128 comments on the proposed 2 You may view the data sheet on the Internet at oviposition, there will be larval holes https://www.eppo.int/QUARANTINE/insects/ and feeding damage and larval waste rule from a variety of commenters. In Carposina_sasakii/CARSSA_ds.pdf. that is readily apparent on inspection. If addition to notifying members of PPQ’s

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Stakeholder Registry,3 we performed processed into products such as apple for food commodities. These EPA-set outreach activities to the following juice or applesauce, COOL would be tolerances are the maximum levels of industry and trade groups: The U.S. circumvented. pesticide residues that have been Apple Export Council, the U.S. Apple While, as stated above, APHIS does determined, through comprehensive Association, the Washington Apple not administer COOL and, as such, safety evaluations, to be safe for human Commission, the Northwest these concerns are outside the scope of consumption. Tolerances apply to both Horticultural Council, and the Apple our authority, we believe that the food commodities that are grown in the Commodity Committee of Northwest relatively high price of apples imported United States and food commodities Fruit Exporters. from China when compared to domestic that are grown in other countries and A number of commenters stated that apple prices will prevent a situation imported into the United States. The we produce sufficient apples such as the one described by the EPA tolerance levels are enforced once domestically and should therefore not commenters. A full explanation of the the commodity enters the United States. import apples from China. economic factors associated with this Chemicals such as DDT that are banned Such prohibitions would be beyond rule, including apple pricing, see the in the United States do not have the scope of APHIS’ statutory authority section entitled, ‘‘Executive Order tolerances on food commodities. Federal under the Plant Protection Act (7 U.S.C. 12866 and Regulatory Flexibility Act.’’ Government food inspectors are 7701 et seq., referred to below as the One commenter observed that the responsible for monitoring food PPA). Under the PPA, APHIS may importation of apples from China would commodities that enter the United prohibit the importation of a fruit or bypass U.S. regulations regarding plant States to confirm that tolerance levels vegetable into the United States only if origins, growing practices, and laborer are not exceeded and that residues of we determine that the prohibition is and produce health standards set out by pesticide chemicals that are banned in necessary in order to prevent the the U.S. Environmental Protection the United States are not present on the introduction or dissemination of a plant Agency (EPA), the U.S. Food and Drug commodities. Tolerance levels for all pest or noxious weed within the United Administration (FDA), and the U.S. chemicals that are acceptable for use on States. Department of Labor (DOL). apples may be found in EPA’s Additionally, as a signatory to the While we agree that Chinese regulations in 40 CFR 180.101 through World Trade Organization’s Agreement producers are not subject to DOL rules 180.2020. Tolerance information can on Sanitary and Phytosanitary Measures and regulations, given that DOL’s also be obtained at http://www.epa.gov/ (SPS Agreement), the United States has authority does not extend beyond the pesticides/food/viewtols.htm. Pesticide agreed that any prohibitions it places on United States, we disagree with the use in China is regulated by the Institute the importation of fruits and vegetables assessment that apples from China for the Control of Agrochemicals will be based on scientific evidence would not be subject to agricultural (ICAMA) under the current pesticide related to phytosanitary measures and standards. The regulations and the management law, the ‘‘Regulation on issues, and will not be maintained operational workplan set out Pesticide Administration (RPA)’’. Under without sufficient scientific evidence. requirements, including requirements this authority, all pesticides are required The blanket prohibitions requested by regarding sourcing of apples only from to be registered and all pesticide the commenters would not be in registered places of production and handlers must be licensed. In addition, keeping with this agreement. growing practices which Chinese the ICAMA restricts or bans the use of Another commenter suggested that we producers must meet in order to export any pesticide when evidence shows that should instead focus on importing fruits apples to the United States. Further, the the pesticide is an imminent hazard to and vegetables from Europe instead of FDA samples and tests imported fruits crops, fish, livestock, the environment, China. and vegetables for pesticide residues. or public health. APHIS’s phytosanitary evaluation Yearly monitoring reports and One commenter said that the FDA is process only begins once a country has information on the program may be currently unable to cope with its submitted a formal request for market found here: http://www.fda.gov/Food/ obligation to safety test the current level access for a particular commodity. FoodborneIllnessContaminants/ of imported food coming into U.S. APHIS does not solicit such requests, Pesticides/UCM2006797.htm. markets. The commenter asserted that nor do we control which countries A number of commenters were allowing the importation of apples from submit requests. concerned about the environmental China would prove overly burdensome. One commenter said that we should state of China, citing in particular, As stated previously, the FDA require that every imported apple be heavy metal pollution in the Chinese samples and tests imported fruits and labeled as a product of China. air, water, and soil as a specific concern. vegetables for pesticide residues. We Under the Country of Origin Labeling The commenters further suggested that have received no indication from the (COOL) law, which is administered by potential Chinese use of pesticides FDA that they are unable to successfully the Agricultural Marketing Service, currently banned in the United States carry out these duties. Furthermore, the retailers, such as full-time grocery would lead to contamination of crops commenter provided no support for the stores, supermarkets, and club shipped from that country. assertions regarding the FDA’s oversight warehouse stores, are required to notify While the United States does not have capabilities. their customers with information direct control over pesticides that are regarding the source of certain food, used on food commodities such as Comments on APHIS Oversight including fresh and frozen fruits. Any apples in other countries, there are Several commenters stated that there apples imported from China would be regulations in the United States exists doubt that APHIS possesses the subject to such requirements. concerning the importation of food to necessary resources to oversee and Other commenters stated that, if ensure that commodities do not enter monitor the terms of the operational imported Chinese apples were to be the United States containing illegal workplan and successfully intercept any pesticide residues. Through section 408 quarantine pests as necessary. The 3 You may sign up for the PPQ Stakeholder Registry on the Internet at https:// of the Federal Food, Drug, and Cosmetic commenters cited governmental budget public.govdelivery.com/accounts/USDAAPHIS/ Act, the EPA has the authority to cuts and staffing levels as the reason for subscriber/new/. establish, change, or cancel tolerances these systemic weaknesses.

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APHIS has reviewed its resources and Like the United States, China is a While it is true that after initial believes it has adequate coverage across signatory to the SPS Agreement. As APHIS approval of the export program the United States to ensure compliance such, it has agreed to respect the is made, the required regular with its regulations, including the phytosanitary measures the United inspections are the responsibility of the Chinese apple import program, as States imposes on the importation of NPPO of China, APHIS may request established by this rule. In addition, the plants and plant products from China submission of inspection records at any APHIS International Services Area when the United States demonstrates time. In addition, port of entry Director in Beijing serves as APHIS’ the need to impose these measures in inspection is performed by trained representative in China in order to order to protect plant health within the agriculture specialists employed by U.S. assess the operations of the program United States. The PRA that Customs and Border Protection (CBP). there. accompanied the proposed rule A commenter pointed out that we had Two commenters asked how APHIS provided evidence of such a need. That modeled the systems approach on a will regulate apple shipments to avoid being said, as we mentioned in the similar systems approach for the the importation of leaves and debris, proposed rule, APHIS will monitor and importation of pears from China, and which, the commenter stated, may pose audit China’s implementation of the that pears imported under this protocol a risk of introducing pests which may systems approach for the importation of had sometimes been determined to be not feed or reproduce in or on the fruit. apples into the continental United infested with plant pests. The APHIS inspectors have the authority States. If we determine that the systems commenter stated that this calls into to reject consignments that contain approach has not been fully question the efficacy of China’s ability contaminants such as leaves and other implemented or maintained, we will to employ the systems approach. plant debris, especially if any pests are take appropriate remedial action to The pest interceptions referred to by found to be generally infesting that ensure that the importation of apples the commenter were 15 infested pears shipment. As stipulated in § 319.56– from China does not result in the over a 15 year period. Given the lengthy 3(a), ‘‘All fruits and vegetables imported dissemination of plant pests within the time period in question and the level of under this subpart, whether in United States. imports during that time, this commercial or noncommercial The report referenced by the interception rate does not call into consignments, must be free from plant commenter was prepared by the United question the efficacy of the systems litter or debris and free of any portions States Department of Agriculture’s approach, but rather underscores its of plants that are specifically prohibited (USDA) Economic Research Service 5 quality. in the regulations in this subpart.’’ utilizing data collected by the FDA. The One commenter stated that Chinese One commenter stated that APHIS report found that three broad categories producers are not subject to the same would be unable to directly participate of products—fish and shellfish, fruit regulatory oversight as U.S. producers and therefore would be at a competitive in the Chinese import program until products, and vegetable products— advantage. The commenter said that the such time as a pest infestation or other combined accounted for 70 to 80 United States should not accept any problem arose. The commenter percent of FDA import refusals from produce or products from China for that suggested that APHIS expand its China in recent years. Fruit and reason. oversight to allow for action prior to that vegetable products are those that have point. As stated previously, such a been processed in China before being prohibition would be beyond the scope Contrary to the commenter’s shipped to the United States, whereas assertion, our standard practice is to of APHIS’ statutory authority under the the main concern when it comes to PPA, whereby APHIS may prohibit the conduct site visits prior to the initiation contamination of unprocessed fruits and of any import program. This is to ensure importation of a fruit or vegetable into vegetables is the presence of plant pests the United States only if we determine that all required mitigations are in place being introduced into the United States and the agreed upon operational that the prohibition is necessary in via the importation of unprocessed order to prevent the introduction or workplan is being enforced. Subject fruits and vegetables. Given the findings matter experts inspect production sites dissemination of a plant pest or noxious of the PRA, we are confident that the weed within the United States. and packinghouses and report their systems approach required for apples findings to APHIS. Furthermore, the Additionally, as a signatory to the from China will mitigate the risk posed World Trade Organization’s SPS operational workplan authorizes the by such apples to introduce these pests. APHIS International Services Area Agreement, the United States has agreed The other paper cited by the other that any prohibitions it places on the Director in Beijing to conduct periodic commenter refers only to the effects of audit visits of production sites. importation of fruits and vegetables will arsenic in drinking water and not to be based on scientific evidence related Comments on Chinese Oversight food contamination. As stated to phytosanitary measures and issues, previously, FDA samples and tests A number of commenters expressed and will not be maintained without imported fruits and vegetables for distrust in the Chinese NPPO’s ability to sufficient scientific evidence. The pesticide residues as well as other maintain the program at an acceptable blanket prohibition requested by the adulterants and additives, such as level of compliance. One commenter commenters would not be in keeping arsenic. specifically cited an FDA report that with this agreement. Several commenters expressed One commenter said that, apart from highlights risks associated with China’s concern that the rule gives authority for inadequate enforcement of food safety the requirements specifically listed in inspecting for pests to the NPPO of the regulations and the operational standards. Another commenter stated China and therefore U.S. phytosanitary that contaminants such as arsenic are of workplan, the methods of growth, security would be under the purview of harvest, treatment, and export of apples concern, citing a paper entitled ‘‘Current a foreign government. Research Problems of Chronic from China are generally unknown. The 4 commenter argued that this makes it Arsenicosis in China’’ (June 2006). 5 The report, entitled, ‘‘Imports From China and Food Safety Issues,’’ (July 2009) may be viewed on difficult for APHIS to ensure that the 4 You may view the paper on the Internet at the Internet at http://www.ers.usda.gov/media/ apples were handled with care, without http://bioline.org.br/pdf?hn06022. 156008/eib52_1_.pdf. pesticides banned in the United States,

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and with the precautions necessary to efficacy of the systems approach into Another commenter observed that prevent the introduction of invasive question. The commenter concludes certain areas in the United States must pests. The commenter concluded that, that interception records cover only establish buffer zones to keep non- until a more strictly monitored set of known interceptions and ignores the commercially grown apples separated requirements are established, APHIS possibility of infested or diseased fruit from high production orchards in order should not allow the importation of that is imported but not detected. to maintain pest freedom. The apples from China. For the reasons explained in the commenter stated that phytosanitary We disagree with the commenter’s proposed rule, the RMD, and this final treatments or other measures, such as assessment. The commenter is asking rule, we consider the provisions of this those we proposed to require for apples for certain requirements that either the final rule adequate to mitigate the risk from China, were insufficient to achieve mandatory systems approach does associated with the importation of this separation domestically and require or does not need to address for apples from China. The commenters did therefore a similar quarantine is reasons we have explained above. not provide any evidence suggesting necessary in China. Further, the commenter’s that the mitigations are individually or APHIS will require bagging and characterization of the extent of the collectively ineffective. phytosanitary treatment to mitigate risk operational workplan is incorrect. While One commenter suggested that past of fruit flies and other insects in apples the regulations themselves are written history bears out the fact that invasive imported from China. The bagging is an more broadly to allow for programmatic species from China may prove to be equivalent measure to a domestic flexibility, operational workplans destructive plant pests. The commenter quarantine since, done correctly, establish detailed procedures and cited the brown marmorated stink bug, bagging excludes pest species from the guidance for the day-to-day operations Halyomorpha halys, and the vinegar fly, fruits. We are also requiring additional of specific import/export programs. Drosophila suzukii, as two examples mitigation measures including Workplans also establish how specific that are causing significant damage to fumigation plus refrigeration for those phytosanitary issues are dealt with in American crops. apples grown in areas where the the exporting country and make clear As stated above, we consider the Oriental fruit fly is known to exist. In who is responsible for dealing with provisions of this final rule adequate to the United States, bagging is not used as those issues. mitigate against the pests of concern as a mitigation measure for fruit because of The NPPO of China is expected to identified by the PRA. Specific to the the labor requirements necessary to bag maintain program records for at least 1 commenter’s examples, both pests have each fruit. Bagging is used as a year and provide them to APHIS upon been present in the United States for mitigation for fruit from China, Japan, request. One commenter asked why we many years and originated in Asia, not and Korea, because it is a culturally only expect the NPPO of China to necessarily China in particular. The indigenous mitigation to those countries maintain program records for 1 year. brown marmorated stink bug most likely and because large scale labor at a lower The commenter suggested that we make entered the United States as a cost is available to apply the mitigation. record maintenance a permanent hitchhiking overwintering in a One commenter stated that while the requirement. cargo container. Drosophila suzukii RMD asserts that the designated There is no technical justification for possibly made its initial entrance via phytosanitary measures will mitigate keeping records for longer than 1 year. importation of strawberries. the risk presented by the importation of If a pest problem is detected, the Strawberries have been permitted entry apples from China into the continental immediate past records will likely offer from almost all countries since well United States, the document makes no the most valuable information necessary before APHIS began requiring PRAs. claim as to a specific amount of risk to aid in resolution of the issue. This Neither of these pests has been reduction. The commenter further states period of time is the APHIS standard for identified as being associated with a that the RMD does not establish an almost all pest programs and there is no crop that has been permitted appropriate level of phytosanitary special justification to extend it here. importation into the United States protection, or state that the listed subsequent to the preparation of a PRA. mitigation measures will achieve such a General Comments on Phytosanitary Rather they are hazards of international level. The commenter said that the PRA Security trade, which occur infrequently over the should provide more precise and A commenter expressed concern that span of decades. preferably quantitative information apples from China pose a high risk of Another commenter stated that APHIS about the likelihood that imported apple introducing quarantine pests into the lacks information on the full range of fruit would transmit any actionable pest United States. Another commenter pests associated with apples imported or disease. The commenter concluded asked that APHIS prove that any pests from China as Chinese literature sources that APHIS has never established or associated with the importation of have proven deficient or incomplete. published any explicit level, either apples from China would lend We disagree. The PRA that qualitative or quantitative, by which it themselves to effective control measures accompanied the proposed rule consistently judges risk. if they were to become established in provided a list of all pests of apples APHIS believes that a qualitative the United States. Another commenter known to exist in China. This list was analysis is appropriate in this situation. asked if APHIS has experience with the prepared using multiple data sources to APHIS’ evaluations are based on science listed pathogens to ensure that the ensure its completeness. For this same and conducted according to the factors proposed mitigations will be effective in reason, we are confident it is accurate. identified in § 319.5(d), which include controlling diseases that are not present Further, the pest complex associated biosecurity measures, projected export in the United States. Another with apples from China is very similar quantity, and the proposed end use of commenter said that the RMD’s report of to the pest complex associated with the imported commodity (e.g., 15 pest interceptions in 15 years in the pears from China, which have been propagation, consumption, milling, Chinese pear importation program, imported into the United States for 15 decorative, processing, etc.). Most of which features a similar pest complex years under a very similar systems APHIS’ risk assessments have been, and and mitigation measures as were approach with very few pest continue to be, qualitative in nature. proposed for Chinese apples, calls the interceptions. Contrary to the commenter’s assertion

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

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The same commenter cited Article 5.4 confident in its efficacy as a mitigation. The same commenter said that the of the SPS Agreement, which requires As stated previously, APHIS’ PRA’s lack of information concerning that members institute phytosanitary evaluations are based on science and pest and disease prevalence in China requirements while simultaneously conducted according to the factors calls into question the adequacy of minimizing negative trade effects; and identified in § 319.5(d). Specifically, China’s pest and disease surveillance Article 5.6, which requires that paragraph (d)(5) of that section requires programs and added that the PRA does members ensure that any required that any country requesting market not provide the information necessary phytosanitary measures are not more access for a specific commodity to for a determination regarding the trade-restrictive than necessary, taking submit a full account of measures adequacy of pest and disease into account technical and economic currently utilized in-country to mitigate surveillance. The commenter stated that feasibility. The commenter noted that against pests of concern in a domestic there may be pests and diseases of the RMD contains no analysis indicating setting. We also require references to concern not considered by the PRA and that the proposal is compliant with back up the information supplied by the RMD due to the potential inadequacy of these articles and goes on to state that country. APHIS then conducts its own Chinese phytosanitary surveillance. the RMD only evaluates one option, assessment of the in-country As stated previously, APHIS’ which consists of 14 specific measures. mitigations, which includes multiple evaluations are based on science and The commenter suggested that, if site visits in order to assess potential conducted according to the factors evaluated individually and in varying places of production, packinghouses, identified in § 319.5(d). Specifically, the combinations, fewer than the 14 etc. We are confident that we have fully requirements of paragraphs (d)(4) and measures presented might prove taken into account the ability of Chinese (d)(5) of that section require that any sufficient to mitigate the phytosanitary producers and the NPPO of China to country requesting market access for a risk posed by apples from China, a meet the standards set out in the specific commodity must submit to smaller systems approach that would be systems approach and the operational APHIS a complete list of pests present easier to implement and less trade- workplan. in that country that are associated with restrictive. The same commenter stated that the commodity in question as well as APHIS has determined that the listed Article 6.3 of the SPS Agreement the measures currently utilized in- risk management measures, along with requires that, ‘‘Exporting Members country to mitigate against those pests the requirement of a phytosanitary claiming that areas within their in a domestic setting. We also require certificate and the port of entry territories are pest- or disease-free areas references to back up the information inspection, will mitigate the risk of pest or areas of low pest or disease supplied by the country. APHIS then introductions on apples from China into prevalence shall provide the necessary conducts its own assessment of the pest the continental United States. While evidence thereof in order to objectively complex and in-country mitigations, bagging is the primary mitigation, the demonstrate to the importing Member which includes multiple site visits in other mitigations serve to ensure that no that such areas are, and are likely to order to assess potential places of pests will follow the importation remain, pest- or disease-free areas or production, packinghouses, etc. pathway. Once the system has been in areas of low pest or disease prevalence, Another commenter asked if APHIS place and is operational, it may become respectively.’’ The commenter said that will require a trapping program be clear that some mitigations may be APHIS does not provide any established for the listed pests of reduced or removed. Prior to the information about evidence provided by concern. program becoming operational, APHIS As stated in the proposed rule, China concerning pest- or disease-free will not remove mitigations since, as paragraph (b)(1) would require the place areas or areas of low pest or disease stated previously, a similar systems of production to carry out any prevalence within China or within approach is successfully utilized for the phytosanitary measures specified for the specific regions in China. The importation of pears from China. place of production under the commenter concluded that it appears Although the bagging requirement operational workplan. Depending on the that APHIS never even considered the differs slightly from that used for pears, location, size, and plant pest history of existence of pest- or disease-free areas or we have detailed previously why the the orchard, these measures may areas of low pest or disease prevalence. phytosanitary protections otherwise include surveying protocols or remain the same. While the section of the SPS application of pesticides and fungicides. The commenter went on to state that Agreement cited by the commenter is Trapping programs may be required in the RMD provides no evidence to accurate concerning official recognition the case of fruit fly, key Lepidoptera, support the assertion that the 14 of pest- or disease-free areas or areas of and/or weevils. This will be decided on phytosanitary measures are sufficient to low pest or disease prevalence, the a case-by-case basis, with the details of mitigate the pest risk associated with recognition of such areas requires a any such programs laid out in the the importation of apples from China. In formal request be made on the part of operational workplan. particular, the commenter observes that the exporting country. China did not there is no description of apple growing request that APHIS recognize any such Comments on the Pest List or commercial apple processing in areas. Consequently, APHIS is not The PRA that accompanied the China that would support the claim that establishing formal pest- or disease-free proposed rule identified 21 pests of standard packinghouse procedures, areas or areas of low pest or disease quarantine significance present in China such as culling and inspection, will prevalence in relation to the importation that could be introduced into the prove efficacious. Similarly, another of apples from China, nor are such continental United States through the commenter stated that the required designations a requirement for the importation of Chinese apples: inspections do not guarantee that importation of commodities into the • Adoxophyes orana (Fischer von quarantine pests will not be introduced. United States. As stated previously, we Ro¨slerstamm), summer fruit tortix. APHIS (and its predecessor agencies are confident that the systems approach • Archips micaceana (Walker), a within the USDA) has been relying on provides the necessary pest mitigation moth. inspection for almost 100 years to for the importation of apples into the • Argyrotaenia ljungiana (Thunberg), remove pests and we are therefore continental United States. grape tortix.

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

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

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pest from China, but was not considered () is not on the pest list, fructigena-infected fruit are sporulating in the APHIS PRA. Leucoptera malifoliella (Costa) is listed in close proximity to host material, they The bagging requirement discussed with a high risk of following the cannot infect it and we consider this above should effectively exclude pathway and will be mitigated as possibility unlikely. Other specific Curculionidae. In addition, weevils described previously. Lyonetiidae is the members of Monilinia sp. are discussed typically leave feeding damage and family name for this pest, Costa is the below. holes with frass that are easily visible authority. They are the same pest, One commenter said that it needs to upon inspection. We would note that notated differently. Finally, in a risk be demonstrated, through scientific we analyzed Rhynchites heros Roelofs analysis titled, ‘‘Phytosanitary Risks study and examination of mature fruit and determined that it presents a Associated with Armored Scales in taken from orchards which have medium risk of introduction via the Commercial Shipments of Fruit for suffered epidemics at several early importation pathway and that Consumption to the United States’’ seasonal timings, that latent infections Rhynchites coreanus Kono is a synonym (June 2007) 6 we determined that the of the fungus Monilinia ma/1, which is of Rhynchites heros Roelofs. likelihood of introduction of armored the causal agent of monilia leaf blight, Contrary to the commenter’s scales via the specific pathway are not sometimes still present later at assertion, Enaptorrhinus sinensis represented by commercially produced harvest on normal appearing fruit. Waterhouse is not listed in the PRA as fruit shipped without leaves, stems, or Field inspection data for Monilinia affecting fruit: ‘‘Adults, which are contaminants is low because these fructigena and Monilinia polystroma moderately large beetles (body length: scales have a very poor ability to was presented by all orchards inspected 6.2–6.4 mm, width: 3.2–3.3 mm; Han, disperse from fruits for consumption in our site visit and certified by the 2002), may feed on apple fruit (You, onto hosts. Females do not possess Chinese Entry and Exit Inspection and 2004), but are considered unlikely to wings or legs; legs are also absent in Quarantine Service. This data shows no remain with fruit through harvest and feeding immature forms. Males are report of the diseases, and if there are post-harvest processing.’’ capable of flight, however they are no disease records, then there can be no Neomyllocerus hedini (Marshall) is short-lived, do not feed, and tend to latency problem such as the commenter listed as affecting leaves but not fruit. mate only with nearby females. For this described. In addition, packinghouse As for the other weevils cited by the reason, the armored scale Diaspidiotus inspections show no history of the commenter, we found no evidence (= Quadraspidiotus) slavonicus (Green) disease. during our assessment that those pests The same commenter said that the is not a pest of concern. were likely to follow the pathway. One commenter stated that since the fungus Monilinia mali, which does not The same commenter observed that, of the fungus Botryosphaeria occur in the United States, was not since members of the Diapididae and included in the listing of actionable dothidea is under active consideration Pseudococcidae families of scale insects pests reported on apples in any country by the research community, the feed on stems, leaves, and fruit in U.S. and present in China on any host and assertion that the Asian Botryosphaeria apple orchards and are treated as should be added. The commenter dothidea is the same species as is found quarantine pests in many countries additionally stated that the fungus in the United States is not settled around the world, the following species Monilinia polystroma should be added science. The commenter argued that should have been included in the PRA: to that list as well, as it has been they should be considered distinct Diaspidiotus (= Quadraspidiotus) reported to attack apples in Europe and species until scientists from China slavonicus (Green), Phenacoccus has been recently reported from China. pergandei Cockerell, Spilococcus provide additional studies Contrary to the commenter’s (= Atrococcus) pacificus (Borchsenius), demonstrating that they are assertion, both pathogens are listed. and Leucoptera malifoliella synonymous. Currently there is only a single report of We disagree. The most recent and (Lyonetiidae). 7 Monilinia polystroma on apples. That Another commenter said that the conclusive study on this matter found identification is debatable since it was PRA’s determination of a negligible that the causal agent of apple ring spot based on molecular evidence alone. The possibility of Japanese wax scale and apple white rot was the same. The European report stated that the (Ceroplastes japonicas) following the agent was identified as Botryosphaeria symptoms disappeared after the initial pathway of importation was based on dothidea for both diseases. Thus, the observation. Thus, the observations the idea that Chinese apples will be pathogen is present in both the United have not been replicated outside of this safely discarded. The commenter stated States and China. single incident. In Japan and China, Another commenter stated that there that, if even a small percentage of where stone fruit (the primary host for is an unknown risk of fungi of the genus imported apples are discarded the pathogen) and apples are grown in Monilinia escaping detection. improperly, there is risk, particularly if close proximity, there are no reports of We disagree with the commenter’s they are discarded near host material. Monilinia polystroma on apples. Despite assertion regarding unknown risk. In general, scale insects are excluded the weak evidence, we did analyze Monilinia mali is unlikely to be present via washing, brushing, spraying with Monilinia polystroma and found it to be on mature fruit. Monilinia fructigena is compressed air, culling, and inspection. high risk. It was therefore considered unlikely to come in contact with host These mandatory measures will be a when we were developing the material, since spores need to be near part of the operational workplan. requirements of the systems approach actual apple trees. Unless Monilinia However, Phenacoccus pergandei and will be considered in development Cockerell is found to affect leaves only, of the operational workplan. There is 6 Copies of the full analysis are available by Spilococcus (= Atrococcus) pacificus contacting the person listed under FOR FURTHER also considerable uncertainty about the (Borchsenius) is found to affect stems INFORMATION CONTACT. presence of Monilinia mali but it was only, and Ceroplastes japonicas is found 7 That study, Phylogenetic and pathogenic also listed. However, it was not to affect both leaves and stems. The analyses show that the causal agent of apple ring analyzed because it is not found on rot in China is Botryosphaeria dothidea, may be commenters provided no evidence that found on the Internet at http:// mature fruit. these scales were of concern on fruit. apsjournals.apsnet.org/doi/pdf/10.1094/PDIS-08- The PRA lists certain organisms that Although Leucoptera malifoliella 11-0635. APHIS is only able to identify to the

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

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national agriculture; if significant available on this species, primary operational workplan associated with damage was to occur again, it would records of detections on apple should be the importation of apples from China have been reported in the literature. available, if extant. Given the lack of will be very similar to the workplan for While there is some uncertainty such primary records, we consider the the importation of pears from China, regarding the cause of the absence of listing of apples as a natural host for which has been used to mitigate risk Pempelia heringii infestations, based on Eutetranychus orientalis dubious and successfully for the past 15 years. This available literature, the potential for therefore we did not include it on the will likely include such requirements as damage in the United States is pest list. field inspection, orchard control, considered low. The same commenter stated that the culling, and spraying with compressed The same commenter stated that the peach fruit moth (Carposina sasakii) is air. Pseudococcus cryptus was not treated as not meeting the criteria for We proposed to require that, when considered a candidate for risk spread potential in the PRA, but that the any apples destined for export to the management in the PRA because risk of PRA also states that the lack of spread continental United States are still on the establishment was considered first, and is due to strict quarantine regulations. tree and are no more than 2 centimeters since that was deemed negligible, the The commenter went on to say that this in diameter, double-layered paper bags likelihood of introduction was not is a serious pest in infested regions and must be placed wholly over the apples. evaluated. The commenter said the should be included for risk We are making a minor change to the argument regarding negligible management. requirements as they pertain to when establishment is based on the idea that We concluded in the PRA that the the bags are placed as they were set out it is unlikely that an infested fruit will peach fruit moth was likely to cause in the proposed rule. Instead of be discarded near a potential host, as unacceptable consequences if requiring that bags be placed over the well as the presumed frailty of the introduced into the United States. It was apples when they are no more than 2 crawlers. The commenter went on to say assigned a medium likelihood of centimeters in diameter, we are that, in the event that apples are or introduction and is therefore covered by requiring that the bags be placed over become a host, the crawlers of other the requirements in the systems the apples when they are no more than mealybug species are known to approach. 2.5 centimeters in diameter. The 2 centimeter diameter specified in the aggregate around the calyx of fruit, Comments on the Systems Approach which would provide shelter and render proposed rule was an error and the them difficult to detect and therefore the We proposed to require the NPPO of change to 2.5 centimeters is necessary to absence of any mealybug species from China to provide an operational keep the regulations in line with the PRA list for risk management workplan to APHIS that details the bagging protocols for pears from China. measures should be examined. activities that the NPPO would, subject The change from 2 centimeters to 2.5 The mealybug analysis concludes as to APHIS’ approval of the workplan, centimeters will have no effect on the follows: ‘‘Dispersal by wind is carry out to meet the requirements of phytosanitary safety of the young apple dependent on prevailing wind direction; the regulations. An operational fruit. At this stage in the fruit’s growth nymphs have no control over where workplan is an agreement between PPQ, any attacks made by surface feeding or they are blown. This dispersal strategy officials of the NPPO of a foreign internally feeding pests will lead to relies on a very high number of nymphs, government, and, when necessary, visible deformation of the fruit and to so that a few will arrive serendipitously foreign commercial entities that fruit drop. Further, an increase of 0.5 on a suitable new host. Commercial fruit specifies in detail the phytosanitary centimeters in fruit diameter at this arriving in the United States is highly measures that will comply with our stage represents generally a week’s unlikely to carry high populations of regulations governing the import or worth of growth, which is insufficient pregnant females. Crawlers would be export of a specific commodity. time for any widespread infestation of unlikely to survive shipment, especially Operational workplans establish young fruit to occur. in chilled, low humidity conditions. detailed procedures and guidance for Two commenters asked which studies Some people dispose of inedible fruit in the day-to-day operations of specific confirm APHIS’s assertion that bagging outdoor compost bins, but since only a import/export programs. Workplans also the fruit will mitigate all the pests of small number of fruit are likely to be establish how specific phytosanitary concern discussed in the PRA. Another infested, only very rarely would infested issues are dealt with in the exporting commenter wanted to know whether fruit be composted. For these reasons, country and make clear who is APHIS can prove the effectiveness of arriving on commercial fruit responsible for dealing with those fruit bagging as a phytosanitary for consumption have a negligible issues. The implementation of a systems mitigation based on the volume of likelihood of dispersing to hosts.’’ approach typically requires an apples that will likely be shipped. Sufficient evidence to change this has operational workplan to be developed. Another commenter pointed out that we not been presented. Two commenters stated that since the had modeled the bagging protocol on a The same commenter observed that operational workplan, in particular the similar protocol for the importation of the oriental red mite (Eutetranychus section on required production pears from China, and that pears orientalis) was dismissed as a risk by practices, has not yet been approved by imported under this protocol had the PRA as there were no records APHIS it was impossible to adequately sometimes been determined to be indicated in a ‘‘thorough National evaluate the risks of the proposal. infested with plant pests. The Agricultural Library, Google Scholar, Another commenter asked us to present commenter stated that this calls into and PestID database search.’’ The details of the operational workplan. question the efficacy of this mitigation. commenter stated that, to the contrary, Generally speaking, APHIS does not We did not claim that the required there is literature that lists finalize an operational workplan until bagging will serve as sole mitigation for Eutetranychus orientalis as a pest of after the rule itself is finalized given that the pests of concern listed in the PRA. apple and other rosaceous hosts. changes may be made to the rule as a The entire systems approach, which This species is a well-known and result of public comment. However, comprises a number of requirements thoroughly researched pest of citrus. given the similarity of the systems working in concert, will provide that Given the vast amount of literature approaches, we anticipate that the mitigation. While we do not possess

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

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markets given that the phytosanitary As detailed in the initial regulatory final regulatory flexibility analysis, standards required to access non-U.S. flexibility analysis that accompanied the apples are not inexpensive to produce markets may be weaker. proposed rule and restated in the final in China due, in large part, to Requiring a facility be dedicated for regulatory flexibility analysis associated differences between the way the apple shipping only to the United States is not with this rule, we find it unlikely that industry is structured in the United technically justified if that facility can the importation of apples from China States and China. Most apple growers in demonstrate and practice effective will represent a cost to the U.S. apple China operate on a very small scale and methods for identifying and segregating industry or to U.S. consumers. This is production is labor-intensive, requiring fruit destined for different markets. due to the relatively small amount of significant labor resources to plant, Comments on the Economic Analysis apples that are expected to be exported tend, and harvest the crop. and qualitative factors associated with One commenter urged APHIS to We prepared an initial regulatory consumer demand such as variety, support and encourage consumers in flexibility analysis in connection with flavor (acids, sugars, aroma), juiciness, doing business with local farmers. The the proposed rule regarding the crispness, firmness, appearance (color, commenter claimed that the low price of economic effects of the rule on small shape and size), freshness, perceived Chinese apples would cause domestic entities. We invited comments on any health benefits, production method producers economic distress. potential economic effects and received (organic or conventional), and product We would observe that consumer a number of comments. Those origin (local, regional, domestic or practices when purchasing fresh apples comments are discussed and responded import). Moreover, trade with China are influenced by factors other than to in detail in the final regulatory represents an opportunity for potential price. These factors include variety, flexibility analysis associated with this expansion of the U.S. export market and size, color, flavor, texture, freshness, final rule. Copies of the full analysis are the benefits associated with such an product origin, and production method. available on the Regulations.gov Web expansion. American consumers benefit from a site (see footnote 1 in this document for One commenter claimed that China is diverse and abundant supply of fresh a link to Regulations.gov) or by not an open market for fair trade and, apples that are locally, regionally, and contacting the person listed under FOR as a result, efforts to market U.S. apples nationally distributed to them; it is FURTHER INFORMATION CONTACT. in China in return for allowing Chinese highly unlikely that China will become a dominant supplier. Comments on General Economic Effects apples access to U.S. markets will prove unsuccessful. Another commenter said Comments on Bilateral Trade While specific comments on the that, in the past, China claimed that U.S. initial regulatory flexibility analysis are apples presented unacceptable Several commenters pointed out that addressed in the final regulatory phytosanitary risk and subsequently access to Chinese markets for U.S. flexibility analysis as previously stated, halted all importation of apples from the apples is not currently assured at this we received a number of comments United States into China. The point in time. The commenters asked concerning the overall economic effect commenter stated that this was done that APHIS make sure that the proposed of the rule as it relates to U.S. trade without substantiated claims or rule would not be finalized before policies concerning China that are more investigation as a tactic to force the reciprocal market access is granted. One appropriately addressed here. United States to open its markets to of the commenters added that, if One commenter stated that APHIS did Chinese apples. Chinese apples were able to be imported not meet those requirements of We disagree with the claim that into the United States, but U.S. apples Executive Order 13563 that specify that China’s prohibition on the importation could not be exported to China, then the agencies must take into account the of apples from the United States was underlying assumptions concerning the benefits and costs, both qualitative and without basis and was motivated by economic impact of the importation of quantitative, of the rules they bilateral trade concerns. In 2012, the apples from China would prove promulgate. The commenter specifically NPPO of China suspended access for red incorrect. Another commenter stated said that APHIS had failed to and golden delicious apples from the that, if China were to allow for the demonstrate that the proposed rule State of Washington due to repeated importation of apples from the United provided any benefit to U.S. consumers interceptions of three apple pests the States, there is concern that small and stakeholders. NPPO considers significant: Speck rot American producers will not be able to We disagree with the commenter’s (caused by Phacidiopycnis make such market access opportunities assessment. Executive Order 13563 washingtonensis), bull’s-eye rot (caused profitable. Another commenter requires that agencies propose or adopt by four species of Neofabraea), and suggested that APHIS regulate the a regulation upon a reasoned Sphaeropsis rot (caused by Sphaeropsis amount and variety of apples allowed determination that its benefits justify its pyriputrescens). In response, APHIS into the United States from China. costs (recognizing that some benefits worked with the U.S. apple industry to Other countries make decisions as to and costs are difficult to quantify). The develop additional safeguarding whether to allow the importation of U.S. Executive Order also states that, where measures to address China’s concerns products only when formally requested. appropriate and permitted by law, each about these pests. As a result, red and APHIS formally requested that China agency may consider (and discuss golden delicious apples were permitted allow the importation of U.S. apples, qualitatively) values that are difficult or to be imported from the United States and we worked with the U.S. apple impossible to quantify, including into China beginning in early November industry to address concerns raised by equity, human dignity, fairness, and 2014. the NPPO of China, resulting in the distributive impacts. The Executive Another commenter stated that successful reopening of the Chinese Order ultimately leaves the type of Chinese import competition affects local apple market to U.S. apple growers in analysis to the discretion of the Agency. labor markets by triggering declines in November 2014. However, APHIS’ We have previously explained the associated wages and employment. primary responsibility with regard to reasons for which APHIS conducts While APHIS is sensitive to the costs international import trade is now, and qualitative rather than quantitative its actions may impose on producers in has been for many years, to identify and analyses. the United States, as detailed in the manage the phytosanitary risks

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associated with importing commodities. In accordance with 5 U.S.C. 604, we China’s exports of fresh apples peaked When we determine that the risk have performed a final regulatory in 2009 at 1.2 million MT and declined associated with the importation of a flexibility analysis, which is to 0.98 million MT in 2012. Most of the commodity can be successfully summarized below, regarding the 4.3 million apple growers in China mitigated, it is our responsibility under economic effects of this rule on small operate on a small scale, with farm the trade agreements to which we are entities. Copies of the full analysis are acreages averaging 1.3 acres. The Fuji signatory to make provisions for the available on the Regulations.gov Web variety accounts for about 70 percent of importation of that commodity. site (see footnote 1 in this document for China’s apple production. China’s heavy Moreover, under the PPA, our a link to Regulations.gov) or by dependence on the Fuji variety is in decisionmaking related to allowing or contacting the person listed under FOR sharp contrast to the many diverse denying the importation of commodities FURTHER INFORMATION CONTACT. varieties produced in the United States. must be based on phytosanitary Apples are the second most popular China’s export markets are concentrated considerations rather than the goal of fresh fruit for U.S. consumers and the in Russia, Southeast Asia, and the reciprocal market access. third most valuable fruit crop produced Middle East. Chinese fresh apples also Another commenter stated that the in the United States. The United States have been exported for more than a PPA requires that APHIS base its is the world’s second largest apple decade to Canada; however, Canada regulations on sound science and that producer and became the world’s largest accounted only for 0.4 percent of the desire for reciprocal apple trade apple exporter in terms of value in 2012, China’s fresh apple exports in 2012. In with China is not science-based. The generating a surplus of $909 million in fact, China’s combined export volume to commenter said that if hope of such fresh apple trade (exports minus Canada, European Union (EU) member mutual access was influential in the imports). That year, the United States countries, Australia, and Mexico is very development of the proposed rule, then commercially produced 4.1 million small (0.8 percent of its total fresh apple the rule is not compliant with the PPA, metric tons (MT) of apples, valued at $3 exports in 2012), and has significantly and therefore illegal. The same billion, of which 3 million MT of apples declined in the last 6 years, from 45,267 commenter also stated that such a were sold fresh and 1.1 million MT MT in 2007 (4.4 percent of Chinese situation violates the conditions of the were used for processing. Although apple exports) to 8,273 MT in 2012. SPS Agreement, particularly Article 2.2, apples are commercially grown in all 50 Average export prices of fresh apples which requires that signatories base States, 9 States accounted for 96 percent from China in 2012 to the sanitary and phytosanitary regulations of production. The State of Washington aforementioned countries (Canada, on scientific principles, and Article 5.1, was by far the largest producer, at more $1.50/kilogram (kg); EU, $1.10/kg; which requires that signatories base than 2.9 million MT per year (over 70 Australia, $1.83/kg; and Mexico, $1.55/ their actions on a risk assessment. The percent of the U.S. total). kg) are consistently higher than the commenter reiterates that reciprocal Almost all apple farms are family- average price paid in all 67 countries to trade is neither a scientific principle nor owned, and many of these families have which China exported fresh apples a risk assessment and APHIS’s proposed been engaged in apple production for ($0.98/kg). It is reasonable to expect that action may therefore be out of many generations. The U.S. apple price for fresh apples exported to the compliance with the SPS Agreement. industry is challenged by relatively flat United States will be similar to prices This action was predicated on several domestic apple consumption, and its paid in Canada and Mexico. risk assessment documents that provide continued growth relies on expanded Considering the current availability of a scientific basis for potential global trade. Roughly 30 percent of fresh relatively low-priced imported apples in importation of apples from China. apples produced in the United States the United States and the wide range of Without these risk assessment were exported in 2012. That year, domestic varieties, apples imported documents, which have withstood roughly 8 percent of fresh apples from China are not likely to compete several reviews and public comment consumed in the United States were solely on price in the U.S. market. U.S. periods, APHIS would not have imported, totaling 183,000 MT and consumers make their purchasing proposed this action. Political and valued at $164 million. Virtually all decisions for fresh apples based not economic interests may stimulate imports came from four trading only on price, but also on intrinsic consideration of the expansion of trade partners: Chile, New Zealand, Canada, product attributes such as variety, color, of agricultural commodities between and Argentina. size, flavor, texture, freshness, countries, but all decisionmaking By quantity, China was the world’s production method, and product origin. concerning phytosanitary restrictions on largest producer, consumer and exporter Based on historic data of China’s trade must be science-based. APHIS of apples in 2012. (In 2013, apple production, consumption, export stands behind the risk assessment became the world’s largest exporter of volumes, and prices, we expect no more documents that support this rule, and apples in quantity, whereas the United than 10,000 MT of fresh apples will be believes they are based on sound States remained the world’s largest imported from China into the science. exporter of apples in value). Apples are continental United States annually, Therefore, for the reasons given in the the leading fruit produced in China, which represents less than 0.44 percent proposed rule and in this document, we with production having increased from of the U.S. domestic fresh apple supply are adopting the proposed rule as a final 2.3 million MT in 1978, to 38.5 million and less than 5 percent of U.S. imports rule, with the changes discussed in this MT (33.3 million MT for fresh markets in 2012. Most of China’s fresh apple document. and 5.2 million MT for processing) in exports to the United States will likely 2012. China’s apple consumption has be shipped to West Coast ports, Executive Order 12866 and Regulatory grown to 37.5 million MT. primarily ones in California, and are Flexibility Act In contrast to that of the United expected to be distributed through This final rule has been determined to States, China’s apple industry relies Asian ethnic supermarkets mainly to be not significant for the purposes of marginally on international trade—in Asian communities. Executive Order 12866 and, therefore, 2012, it exported about 3 percent of California is the largest market for has not been reviewed by the Office of fresh apples produced and imported 0.1 Washington State apples; any effects of Management and Budget. percent of fresh apples consumed. the rule may be borne mainly by

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Washington and California apple recordkeeping requirements, Rice, (2) The apples must be grown at growers. In particular, U.S. apple Vegetables. places of production that are registered growers of the Fuji variety, which with the NPPO of China. comprised about 8 percent of U.S. Accordingly, we are amending 7 CFR (3) Apples from China may be production in 2011, may be more part 319 as follows: imported in commercial consignments directly affected by an increase in only. PART 319—FOREIGN QUARANTINE supply because we expect the majority (b) Place of production requirements. NOTICES of fresh apples from China will be of the (1) The place of production must carry Fuji variety. However, given the out any phytosanitary measures ■ relatively small quantity expected to be 1. The authority citation for part 319 specified for the place of production imported from China, any negative continues to read as follows: under the operational workplan as impacts for U.S. small entities will not Authority: 7 U.S.C. 450, 7701–7772, and described in the regulations. be significant. 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR (2) When any apples destined for 2.22, 2.80, and 371.3. export to the continental United States Executive Order 12988 are still on the tree and are no more than This final rule allows apples to be ■ 2. Section 319.56–72 is added to read 2.5 centimeters in diameter, double- imported into the continental United as follows: layered paper bags must be placed wholly over the apples. The bags must States from China. State and local laws § 319.56–72 Apples from China. and regulations regarding apples remain intact and on the apples until at imported under this rule will be Fresh apples (Malus pumila) from least 14 days prior to harvest. preempted while the fruit is in foreign China may be imported into the (3) The NPPO of China must visit and commerce. Fresh fruits are generally continental United States from China inspect registered places of production imported for immediate distribution and only under the conditions described in prior to harvest for signs of infestation sale to the consuming public, and this section. These conditions are and/or infection. (4) If Monilia polystroma van remain in foreign commerce until sold designed to prevent the introduction of Leeuwen or Monilinia fructigena is to the ultimate consumer. The question the following quarantine pests: detected at a registered place of of when foreign commerce ceases in Adoxophyes orana (Fischer von production, APHIS may reject the other cases must be addressed on a case- Ro¨slerstamm), summer fruit tortix; consignment or prohibit the importation by-case basis. No retroactive effect will Archips micaceana (Walker), a moth; into the continental United States of be given to this rule, and this rule will Argyrotaenia ljungiana (Thunberg), apples from the place of production for not require administrative proceedings grape tortix; Bactrocera dorsalis the remainder of the season. The before parties may file suit in court (Hendel), Oriental fruit fly; Carposina exportation to the continental United challenging this rule. sasakii Matsumura, peach fruit moth; Cenopalpus pulcher (Canestrini & States of apples from the place of Paperwork Reduction Act Fanzago), flat scarlet mite; Cryptoblabes production may resume in the next growing season if an investigation is In accordance with section 3507(d) of gnidiella (Millie`re), honeydew moth; conducted by the NPPO, and APHIS and the Paperwork Reduction Act of 1995 Cydia funebrana (Treitschke), plum the NPPO conclude that appropriate (44 U.S.C. 3501 et seq.), the information fruit moth; Euzophera bigella (Zeller), quince moth; Euzophera pyriella Yang, remedial action has been taken. collection or recordkeeping (c) Packinghouse requirements. (1) requirements included in this final rule, a moth; Grapholita inopinata Heinrich, Manchurian fruit moth; Leucoptera Packinghouses must be registered with which were filed under 0579–0423, the NPPO of China, and during the time have been submitted for approval to the malifoliella (Costa), apple leaf miner; Monilia polystroma van Leeuwen, Asian registered packinghouses are in use for Office of Management and Budget packing apples for export to the (OMB). When OMB notifies us of its brown rot; Monilinia fructigena Honey, brown fruit rot; Rhynchites auratus continental United States, the decision, if approval is denied, we will packinghouses may only accept apples publish a document in the Federal (Scopoli), apricot weevil; Rhynchites bacchus (L.), peach weevil; Rhynchites that are from registered places of Register providing notice of what action production and that are produced in we plan to take. giganteus Krynicky, a weevil; Rhynchites heros Roelofs, a weevil; accordance with the requirements of E-Government Act Compliance Spilonota albicana (Motschulsky), this section. white fruit moth; Spilonota (2) Packinghouses must have a The Animal and Plant Health tracking system in place to readily Inspection Service is committed to prognathana Snellen, a moth; and Ulodemis trigrapha Meyrick, a moth. identify all apples destined for export to compliance with the EGovernment Act the continental United States that enter to promote the use of the Internet and The conditions for importation of all fresh apples from China are found in the packinghouse and be able to trace other information technologies, to the apples back to their place of provide increased opportunities for paragraphs (a) through (e) of this section; additional conditions for apples production. citizen access to Government (3) Following the packinghouse imported from areas of China south of information and services, and for other inspection, the packinghouse must the 33rd parallel are found in paragraph purposes. For information pertinent to follow a handling procedure for the (f) of this section. E-Government Act compliance related apples that is mutually agreed upon by to this rule, please contact Ms. Kimberly (a) General requirements. (1) The APHIS and the NPPO of China. Hardy, APHIS’ Information Collection national plant protection organization (4) The apples must be washed and Coordinator, at (301) 851–2727. (NPPO) of China must provide an brushed as well as waxed or sprayed List of Subjects in 7 CFR Part 319 operational workplan to APHIS that with compressed air prior to shipment. details the activities that the NPPO of (5) The apples must be packed in Coffee, Cotton, Fruits, Imports, Logs, China will, subject to APHIS’ approval cartons that are labeled with the identity Nursery stock, Plant diseases and pests, of the workplan, carry out to meet the of the place of production and the Quarantine, Reporting and requirements of this section. packinghouse.

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(d) Shipping requirements. Sealed require repetitive weighing of fire section. Comments will be available in containers of apples destined for export extinguisher bottles having a certain the AD docket shortly after receipt. to the continental United States must be part number, and eventual replacement FOR FURTHER INFORMATION CONTACT: Tom held in a cold storage facility while of those bottles to terminate the Rodriguez, Aerospace Engineer, awaiting export. repetitive weighing. This AD was International Branch, ANM–116, (e) Phytosanitary certificate. Each prompted by our determination that Transport Airplane Directorate, FAA, consignment of apples imported from certain text in the method of compliance 1601 Lind Avenue SW., Renton, WA China into the continental United States language specified in AD 2013–26–05 98057–3356; telephone 425–227–1137; must be accompanied by a incorrectly refers to Airbus, instead of fax 425–227–1149. phytosanitary certificate issued by the ‘‘Dassault Aviation.’’ We are issuing this SUPPLEMENTARY INFORMATION: NPPO of China with an additional AD to detect and correct a dormant declaration stating that the requirements failure in the fire suppression system, Discussion of this section have been met and the which could result in the inability to On August 29, 2014, we issued AD consignment has been inspected by the put out a fire in an engine, auxiliary 2013–26–05, Amendment 39–17714 (79 NPPO and found free of quarantine power unit (APU), or rear compartment. FR 54897, September 15, 2014), which pests. DATES: This AD becomes effective May applied to all Dassault Aviation Model (f) Additional conditions for apples 8, 2015. FAN JET FALCON, FAN JET FALCON from areas of China south of the 33rd The Director of the Federal Register SERIES C, D, E, F, and G airplanes; parallel. In addition to the conditions in approved the incorporation by reference Model MYSTERE–FALCON 200 paragraphs (a) through (e) of this of certain other publications listed in airplanes; and Model MYSTERE– section, apples from areas of China this AD as of October 20, 2014 (79 FR FALCON 20–C5, 20–D5, 20–E5, and 20– south of the 33rd parallel apples must 54897, dated September 15, 2014). F5 airplanes. AD 2013–26–05 was be treated in accordance with 7 CFR We must receive comments on this prompted by reports of a manufacturing part 305. (Approved by the Office of AD by June 8, 2015. defect in the charge indicator on fire Management and Budget under control ADDRESSES: You may send comments by extinguisher bottles. AD 2013–26–05 number 0579–0423) any of the following methods: required repetitive weighing of fire Done in Washington, DC, this 20th day of • Federal eRulemaking Portal: Go to extinguisher bottles having a certain April 2015. http://www.regulations.gov. Follow the part number, and eventual replacement Kevin Shea, instructions for submitting comments. of those bottles to terminate the Administrator, Animal and Plant Health • Fax: 202–493–2251. repetitive weighing. We issued AD Inspection Service. • Mail: U.S. Department of 2013–26–05 to detect and correct a [FR Doc. 2015–09508 Filed 4–22–15; 8:45 am] Transportation, Docket Operations, M– dormant failure in the fire suppression BILLING CODE 3410–34–P 30, West Building Ground Floor, Room system, which could result in the W12–140, 1200 New Jersey Avenue SE., inability to put out a fire in an engine, Washington, DC 20590. APU, or rear compartment. DEPARTMENT OF TRANSPORTATION • Hand Delivery: U.S. Department of AD 2013–26–05, Amendment 39– Transportation, Docket Operations, M– 17714 (79 FR 54897, September 15, Federal Aviation Administration 30, West Building Ground Floor, Room 2014), corresponds to Mandatory W12–140, 1200 New Jersey Avenue SE., Continuing Airworthiness Information 14 CFR Part 39 Washington, DC, between 9 a.m. and 5 (MCAI) European Aviation Safety Agency (EASA) AD 2012–0189, dated [Docket No. FAA–2015–0830; Directorate p.m., Monday through Friday, except Identifier 2015–NM–024–AD; Amendment Federal holidays. September 24, 2012. You may examine 39–18141; AD 2015–08–05] For service information identified in the MCAI on the Internet at http:// this AD, contact Dassault Falcon Jet, www.regulations.gov by searching for RIN 2120–AA64 P.O. Box 2000, South Hackensack, NJ and locating Docket No. FAA–2015– 07606; telephone 201–440–6700; 0830. Airworthiness Directives; Dassault Since we issued AD 2013–26–05, Aviation Airplanes Internet http://www.dassaultfalcon.com. You may view this referenced service Amendment 39–17714 (79 FR 54897, AGENCY: Federal Aviation information at the FAA, Transport September 15, 2014), we have Administration (FAA), Department of Airplane Directorate, 1601 Lind Avenue determined that there is an error in the Transportation (DOT). SW., Renton, WA. For information on manufacturer’s name in the method of ACTION: Final rule; request for the availability of this material at the compliance language in certain text in comments. FAA, call 425–227–1221. the ‘‘Explanation of Change Made to This AD’’ section and in certain SUMMARY: We are superseding Examining the AD Docket paragraphs of the regulatory text of AD Airworthiness Directive (AD) 2013–26– You may examine the AD docket on 2013–26–05. AD 2013–26–05 refers to 05 for all Dassault Aviation Model FAN the Internet at http:// Airbus’s EASA Design Organization JET FALCON, FAN JET FALCON www.regulations.gov by searching for Approval (DOA), instead of Dassault SERIES C, D, E, F, and G airplanes; and locating Docket No. FAA–2015– Aviation’s EASA DOA. In order to refer Model MYSTERE–FALCON 200 0830; or in person at the Docket to the appropriate EASA DOA, this AD airplanes; and Model MYSTERE– Operations office between 9 a.m. and 5 replaces ‘‘Airbus’s’’ with ‘‘Dassault FALCON 20–C5, 20–D5, 20–E5, and 20– p.m., Monday through Friday, except Aviation’s’’ in paragraphs (h)(2), F5 airplanes. AD 2013–26–05 required Federal holidays. The AD docket (h)(2)(i), (h)(2)(ii), (h)(2)(iii), (h)(2)(iv), repetitive weighing of fire extinguisher contains this AD, the regulatory (i), (i)(1), (i)(2), (i)(3), (i)(4), (j)(1), (j)(2), bottles having a certain part number, evaluation, any comments received, and (j)(3), (j)(4), and (l)(2) of this AD. The and eventual replacement of those other information. The street address for ‘‘Explanation of Change Made to This bottles to terminate the repetitive the Docket Operations office (telephone AD’’ section of AD 2013–26–05 is not weighing. This new AD continues to 800–647–5527) is in the ADDRESSES restated in this AD.

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