Source: https://www.global-regulation.com/law/united-states/30148/importation-of-apples-from-china.html
Timestamp: 2018-05-25 05:20:30
Document Index: 639698282

Matched Legal Cases: ['§ 319', '§ 319', '§ 319', '§ 319', '§ 319', 'art 305', 'art 305', '§ 305', '§ 305', '§ 319', '§ 319']

Importation of Apples From China (United States)
Link to law: https://www.federalregister.gov/articles/text/raw_text/201/509/508.txt
We are amending the fruits and vegetables regulations to allow the importation of fresh apples ( Malus pumila ) from China into the continental United States. As a condition of entry, apples from areas in China in which the Oriental fruit fly ( Bactrocera dorsalis ) is not known to exist will have to be produced in accordance with a systems approach that includes requirements for registration of places of production and packinghouses, inspection for quarantine pests at set intervals by the national plant protection organization of China, bagging of fruit, safeguarding, labeling, and importation in commercial consignments. Apples from areas in China in which Oriental fruit fly is known to exist may be imported into the continental United States if, in addition to these requirements, the apples are treated with fumigation plus refrigeration. All apples from China will also be required to be accompanied by a phytosanitary certificate with an additional declaration stating that all conditions for the importation of the apples have been met and that the consignment of apples has been inspected and found free of quarantine pests. This action allows for the importation of apples from China into the continental United States while continuing to provide protection against the introduction of quarantine pests.
The national plant protection organization (NPPO) of China has requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations to allow apples ( Malus pumila ) from China to be imported into the continental United States.
In response to that request, we prepared a pest risk assessment (PRA) and a risk management document (RMD). Based on the conclusions of the PRA and the RMD, on July 18, 2014, we published in the Federal Register (79 FR 41930-41934, Docket No. APHIS-2014-0003) a proposal 1
to amend the regulations to authorize the importation of fresh apples into the continental United States, provided that the apples were produced in accordance with a systems approach consisting of the following requirements: Production by a grower who is part of a certification program administered by the NPPO of China; fruit bagging; pre-harvest NPPO inspection; packing in packinghouses that are registered with the NPPO; packinghouse procedures including traceback and box marking; post-harvest washing; waxing; treatment with inspection after packing for quarantine pests; issuance of a phytosanitary certificate; importation in commercial consignments only; sealed boxes; and location of apples in a cold storage facility while awaiting export to the continental United States. For apples from those areas of China south of the 33rd parallel, where the Oriental fruit fly ( Bactrocera dorsalis ) is known to exist, we proposed to require treatment in accordance with 7 CFR 305.2, which provides that approved treatment schedules are set out in the Plant Protection and Quarantine (PPQ) Treatment Manual, found online at http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf.
APHIS does not expect this change to significantly increase the risk of pests from China apples. Growers will still be responsible for maintaining low pest populations of target quarantine pests, with oversight by the NPPO of China and APHIS. These measures and others, including removing fallen fruit, will maintain low pest populations in the production sites. The required culling will also remove pests from the pathway. The biometric sampling rate can be increased, if necessary, in order to look for pests that may be present in smaller numbers in consignments, thus heightening the level of phytosanitary security. In addition, the bags will be removed for 2 weeks in the fall, when temperatures are rapidly declining leading to winter and insects are prone to reduced activity leading to dormancy.
Carposina sasakii larvae may bore into the fruit near the calyx, but according to a 2014 data sheet from the European and Mediterranean Plant Protection Organization, “Infested apples exude a sticky gum, pears turn yellow and apricots ripen unevenly.” 2
These symptoms would allow any infested fruit to be readily detected during culling and inspections. The window for the pests to attack after the bags are removed is also very small; for approximately 90 percent of the time after blossom drop and fruit set, the fruit will be protected by bags.
The eight species of Tortricidae, ( Adoxophyes orana,
Archips micaceana,
Ulodemis trigrapha,
Grapholita inopinata,
Spilonota albicana, and Spilonota prognathana ) are leaf rollers. They typically lay eggs on leaves and roll them up and feed on leaf tissue. When fruit are adjacent to leaves, the larvae may attack the fruit, usually leaving external feeding damage and sometimes boring into the fruit leaving visible holes and larval waste. These species are unlikely to be present in any numbers during the fall and are also expected to be controlled by required pest management and standard agricultural best practices. This, combined with the small amount of time that the fruit will be exposed when the bags are removed, will greatly reduce the possibility that these Tortricidae will follow the pathway. In addition APHIS readily inspects for Tortricidae on many commodities. The only time quarantine treatments are required is when high populations and frequent interceptions occur. APHIS does not expect this, but removal of production sites in any problem areas will allow APHIS to mitigate this risk further.
The two treatments we are adding in this final rule are fruit brushing and spraying with compressed air. Fruit brushing will be required as an additional packinghouse treatment requirement, while spraying with compressed air will be an alternative to waxing. Brushing adds another level of phytosanitary protection against surface pests and external spores and spraying with compressed air serves the same purpose as waxing in removing hitchhiking, casual, and surface pests. While brushing and spraying with compressed air are not widely used in fruit processing in the United States, these treatments are commonly used in the fruit packing industry in China and other Asian countries. For example, in § 319.56-65(c)(2), we require spraying with compressed air as a treatment for pineapples imported from Malaysia.
We disagree with the commenter's assessment. As stated above, we received 128 comments on the proposed rule from a variety of commenters. In addition to notifying members of PPQ's Stakeholder Registry, 3
we performed outreach activities to the following industry and trade groups: The U.S. Apple Export Council, the U.S. Apple Association, the Washington Apple Commission, the Northwest Horticultural Council, and the Apple Commodity Committee of Northwest Fruit Exporters.
While we agree that Chinese producers are not subject to DOL rules and regulations, given that DOL's authority does not extend beyond the United States, we disagree with the assessment that apples from China would not be subject to agricultural standards. The regulations and the operational workplan set out requirements, including requirements regarding sourcing of apples only from registered places of production and growing practices which Chinese producers must meet in order to export apples to the United States. Further, the FDA samples and tests imported fruits and vegetables for pesticide residues. Yearly monitoring reports and information on the program may be found here: http://www.fda.gov/Food/FoodborneIllnessContaminants/Pesticides/UCM2006797.htm.
While the United States does not have direct control over pesticides that are used on food commodities such as apples in other countries, there are regulations in the United States concerning the importation of food to ensure that commodities do not enter the United States containing illegal pesticide residues. Through section 408 of the Federal Food, Drug, and Cosmetic Act, the EPA has the authority to establish, change, or cancel tolerances for food commodities. These EPA-set tolerances are the maximum levels of pesticide residues that have been determined, through comprehensive safety evaluations, to be safe for human consumption. Tolerances apply to both food commodities that are grown in the United States and food commodities that are grown in other countries and imported into the United States. The EPA tolerance levels are enforced once the commodity enters the United States. Chemicals such as DDT that are banned in the United States do not have tolerances on food commodities. Federal Government food inspectors are responsible for monitoring food commodities that enter the United States to confirm that tolerance levels are not exceeded and that residues of pesticide chemicals that are banned in the United States are not present on the commodities. Tolerance levels for all chemicals that are acceptable for use on apples may be found in EPA's regulations in 40 CFR 180.101 through 180.2020. Tolerance information can also be obtained at http://www.epa.gov/pesticides/food/viewtols.htm. Pesticide use in China is regulated by the Institute for the Control of Agrochemicals (ICAMA) under the current pesticide management law, the “Regulation on Pesticide Administration (RPA)”. Under this authority, all pesticides are required to be registered and all pesticide handlers must be licensed. In addition, the ICAMA restricts or bans the use of any pesticide when evidence shows that the pesticide is an imminent hazard to crops, fish, livestock, the environment, or public health.
Several commenters stated that there exists doubt that APHIS possesses the necessary resources to oversee and monitor the terms of the operational workplan and successfully intercept any quarantine pests as necessary. The commenters cited governmental budget cuts and staffing levels as the reason for these systemic weaknesses.
APHIS inspectors have the authority to reject consignments that contain contaminants such as leaves and other plant debris, especially if any pests are found to be generally infesting that shipment. As stipulated in § 319.56-3(a), “All fruits and vegetables imported under this subpart, whether in commercial or noncommercial consignments, must be free from plant litter or debris and free of any portions of plants that are specifically prohibited in the regulations in this subpart.”
A number of commenters expressed distrust in the Chinese NPPO's ability to maintain the program at an acceptable level of compliance. One commenter specifically cited an FDA report that highlights risks associated with China's inadequate enforcement of food safety standards. Another commenter stated that contaminants such as arsenic are of concern, citing a paper entitled “Current Research Problems of Chronic Arsenicosis in China” 4
The report referenced by the commenter was prepared by the United States Department of Agriculture's (USDA) Economic Research Service 5
utilizing data collected by the FDA. The report found that three broad categories of products—fish and shellfish, fruit products, and vegetable products—combined accounted for 70 to 80 percent of FDA import refusals from China in recent years. Fruit and vegetable products are those that have been processed in China before being shipped to the United States, whereas the main concern when it comes to contamination of unprocessed fruits and vegetables is the presence of plant pests being introduced into the United States via the importation of unprocessed fruits and vegetables. Given the findings of the PRA, we are confident that the systems approach required for apples from China will mitigate the risk posed by such apples to introduce these pests. The other paper cited by the other commenter refers only to the effects of arsenic in drinking water and not to food contamination. As stated previously, FDA samples and tests imported fruits and vegetables for pesticide residues as well as other adulterants and additives, such as arsenic.
One commenter said that, apart from the requirements specifically listed in the regulations and the operational workplan, the methods of growth, harvest, treatment, and export of apples from China are generally unknown. The commenter argued that this makes it difficult for APHIS to ensure that the apples were handled with care, without pesticides banned in the United States, and with the precautions necessary to prevent the introduction of invasive pests. The commenter concluded that, until a more strictly monitored set of requirements are established, APHIS should not allow the importation of apples from China.
APHIS believes that a qualitative analysis is appropriate in this situation. APHIS' evaluations are based on science and conducted according to the factors identified in § 319.5(d), which include biosecurity measures, projected export quantity, and the proposed end use of the imported commodity ( e.g., propagation, consumption, milling, decorative, processing, etc.). Most of APHIS' risk assessments have been, and continue to be, qualitative in nature. Contrary to the commenter's assertion that a qualitative analysis should include an explicit level of phytosanitary protection, the relative flexibility afforded by a qualitative analysis allows us to evaluate commodity import programs in a holistic way.
It would be inappropriate for APHIS to include an economic analysis in the RMD. Our economic assessment of this action may be found in both the initial regulatory flexibility analysis that was made available with our July 2014 proposed rule and the final regulatory flexibility analysis prepared for this final rule. Copies of the full analyses are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT .
We are confident that packinghouse culling, in concert with the other requirements of the systems approach will be effective in mitigating phytosanitary risk. Any fruit that appeared asymptomatic, as posited by the commenter, would likely be in the early stages of disease or infestation. Given the transit time required to ship apples from China to the United States as well as mandatory port of entry inspections, it is likely that any latent infection or infestation would be detected at this point in the importation process. We have stated in the past that if zero tolerance for pest risk were the standard applied to international trade in agricultural commodities, it is quite likely that no country would ever be able to export a fresh agricultural commodity to any other country and, thus, zero risk is not a realistic standard.
APHIS (and its predecessor agencies within the USDA) has been relying on inspection for almost 100 years to remove pests and we are therefore confident in its efficacy as a mitigation. As stated previously, APHIS' evaluations are based on science and conducted according to the factors identified in § 319.5(d). Specifically, paragraph (d)(5) of that section requires that any country requesting market access for a specific commodity to submit a full account of measures currently utilized in-country to mitigate against pests of concern in a domestic setting. We also require references to back up the information supplied by the country. APHIS then conducts its own assessment of the in-country mitigations, which includes multiple site visits in order to assess potential places of production, packinghouses, etc. We are confident that we have fully taken into account the ability of Chinese producers and the NPPO of China to meet the standards set out in the systems approach and the operational workplan.
As stated previously, APHIS' evaluations are based on science and conducted according to the factors identified in § 319.5(d). Specifically, the requirements of paragraphs (d)(4) and (d)(5) of that section require that any country requesting market access for a specific commodity must submit to APHIS a complete list of pests present in that country that are associated with the commodity in question as well as the measures currently utilized in-country to mitigate against those pests in a domestic setting. We also require references to back up the information supplied by the country. APHIS then conducts its own assessment of the pest complex and in-country mitigations, which includes multiple site visits in order to assess potential places of production, packinghouses, etc.
• Adoxophyes orana (Fischer von Röslerstamm), summer fruit tortix.
• Archips micaceana (Walker), a moth.
• Argyrotaenia ljungiana (Thunberg), grape tortix.
• Bactrocera dorsalis (Hendel), Oriental fruit fly.
• Carposina sasakii Matsumura, peach fruit moth.
• Cenopalpus pulcher (Canestrini & Fanzago), flat scarlet mite.
• Cryptoblabes gnidiella (Millière), honeydew moth.
• Cydia funebrana (Treitschke), plum fruit moth.
• Euzophera bigella (Zeller), quince moth.
• Euzophera pyriella Yang, a moth.
• Grapholita inopinata Heinrich, Manchurian fruit moth.
• Leucoptera malifoliella (Costa), apple leaf miner.
• Monilia polystroma van Leeuwen, Asian brown rot.
• Monilinia fructigena Honey, brown fruit rot.
• Rhynchites auratus (Scopoli), apricot weevil.
• Rhynchites bacchus (L.), peach weevil.
• Rhynchites giganteus Krynicky, a weevil.
• Rhynchites heros Roelofs, a weevil.
• Spilonota albicana (Motschulsky), white fruit moth.
• Spilonota prognathana Snellen, a moth.
• Ulodemis trigrapha Meyrick, a moth.
One commenter stated that many irrelevant species, such as longhorn beetles ( Cerambycidae sp.), were included in the PRA. The commenter said that the PRA should focus only on those pests associated with apple fruit or those that could be transported with the commodity. The commenter said that including a number of species that do not meet those criteria results in a large document, which renders it difficult to assess pests that may be of true significance and thus determine the quality and value of the PRA.
Since the Oriental fruit fly is known to exist, in varying population densities, in areas of China south of the 33rd parallel, apples from such areas will be subject to treatment in accordance with 7 CFR part 305. Within part 305, § 305.2 provides that approved treatment schedules are set out in the PPQ Treatment Manual, found online at http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/treatment.pdf. (The manual specifies that fumigation plus refrigeration schedule T108-a is effective in neutralizing Oriental fruit fly on apples.) The RMD also states that any other treatment subsequently approved by APHIS may be used. One commenter expressed concern at the non-specific nature of those potential alternative treatments.
While APHIS cannot offer specifics on phytosanitary treatments that are not currently approved for use, the language in the RMD is intended to indicate that such treatments may become available in the future. APHIS has a rigorous procedure for approving new quarantine treatments, which includes soliciting comments from stakeholders in accordance with § 305.3. New treatments are tested to a very high standard of efficacy. Generally speaking, that means that an approved treatment is effective in removing 99.99 percent of pests.
While it is true that APHIS has made interceptions of Oriental fruit fly at U.S. ports of entry, most of those interceptions were in passenger baggage. Oriental fruit fly is additionally present in Hawaii, which may lead to a higher number of interstate interceptions.
Another commenter said that melon fly ( Bactrocera cucurbitae ) and solanum fruit fly ( Bactrocera latifrons ) are known pests of apple, but the PRA states that non-cucurbit hosts require confirmation. The commenter reasons that, for such severe pests of commodities other than apple, it would make sense to consider both as potential pests of apple. The commenter asked if there are areas of overlap between the flies' distribution areas and apple growing areas. Lastly, the commenter said that the honeydew moth ( Cryptoblabes gnidiella ) remained on the list in spite of the facts that the pest has a warm climate distribution and that apple is only an occasional host. The commenter said it would therefore be consistent to treat melon fly and solanum fruit fly similarly.
Another commenter asked why apple ring rot ( Macrophoma kawatsukai ) and the fungus, Penicillium diversum, were removed from the pest list when both were present on a draft version of the list. The commenter asked why the genus Penicillium is considered non-actionable at ports of entry.
The same commenter stated that, contrary to APHIS's assertion in the PRA that interception records indicate no association between Tetranychus species of spider mite and commercially produced and shipped apples, the apple industry has experienced infestations of Tetranychus and Panonychus spider mite species in apple production areas. The commenter added that the hawthorn spider mite ( Amphitetranychus viennensis ) could present a similar risk given that it is recorded as attacking leaves, fruit, and blossoms. Another commenter stated that, late in the growing season, hawthorn spider mites sometimes collect in the calices of apples, with either motile forms or eggs present. The commenters urged APHIS to reexamine the data in light of this.
While we have made no changes in response to this comment, as the data we have do not support the commenters' assertion, we do note that typical required mitigations for spider mites are packinghouse procedures ( i.e., washing, brushing, spraying with compressed air), culling, and inspection. Those measures will be included as requirements in the operational workplan and should mitigate against any unforeseen pests of this nature. If one of these pests is detected upon inspection we will take appropriate measures to prevent its introduction into the United States. The hawthorn spider mite was considered in the PRA. It attacks apple leaves; we found no evidence of it being present on fruit.
The same commenter stated that snout beetles ( Curculionidae ) can be serious pests of tree fruit with limited control options. While the commenter noted that the PRA lists a number of Curculionidae species as following the importation pathway, the commenter noted the following additional species of weevils for inclusion: Coenorrhynus sp., Enaptorrhinus sinensis Waterhouse, Involvulus sp., Neomyllocerus hedini (Marshall), Rhynchites coreanus Kono, and Rhynchites heros Roelofs.
Finally, the commenter stated that an Australian PRA cites Rhynchites coreanus Kono as a high-risk quarantine pest from China, but was not considered in the APHIS PRA.
The same commenter observed that, since members of the Diapididae and Pseudococcidae families of scale insects feed on stems, leaves, and fruit in U.S. apple orchards and are treated as quarantine pests in many countries around the world, the following species should have been included in the PRA: Diaspidiotus (= Quadraspidiotus ) slavonicus (Green), Phenacoccus pergandei Cockerell, Spilococcus (= Atrococcus ) pacificus (Borchsenius), and Leucoptera malifoliella ( Lyonetiidae ).
Another commenter said that the PRA's determination of a negligible possibility of Japanese wax scale ( Ceroplastes japonicas ) following the pathway of importation was based on the idea that Chinese apples will be safely discarded. The commenter stated that, if even a small percentage of imported apples are discarded improperly, there is risk, particularly if they are discarded near host material.
In general, scale insects are excluded via washing, brushing, spraying with compressed air, culling, and inspection. These mandatory measures will be a part of the operational workplan. However, Phenacoccus pergandei Cockerell is found to affect leaves only, Spilococcus (= Atrococcus ) pacificus (Borchsenius) is found to affect stems only, and Ceroplastes japonicas is found to affect both leaves and stems. The commenters provided no evidence that these scales were of concern on fruit. Although Leucoptera malifoliella (Lyonetiidae) is not on the pest list, Leucoptera malifoliella (Costa) is listed with a high risk of following the pathway and will be mitigated as described previously. Lyonetiidae is the family name for this pest, Costa is the authority. They are the same pest, notated differently. Finally, in a risk analysis titled, “Phytosanitary Risks Associated with Armored Scales in Commercial Shipments of Fruit for Consumption to the United States” (June 2007) 6
we determined that the likelihood of introduction of armored scales via the specific pathway represented by commercially produced fruit shipped without leaves, stems, or contaminants is low because these scales have a very poor ability to disperse from fruits for consumption onto hosts. Females do not possess wings or legs; legs are also absent in feeding immature forms. Males are capable of flight, however they are short-lived, do not feed, and tend to mate only with nearby females. For this reason, the armored scale Diaspidiotus (= Quadraspidiotus ) slavonicus (Green) is not a pest of concern.
We disagree. The most recent and conclusive study on this matter 7
found that the causal agent of apple ring spot and apple white rot was the same. The agent was identified as Botryosphaeria dothidea for both diseases. Thus, the pathogen is present in both the United States and China.
We disagree with the commenter's assertion regarding unknown risk. Monilinia mali is unlikely to be present on mature fruit. Monilinia fructigena is unlikely to come in contact with host material, since spores need to be near actual apple trees. Unless Monilinia fructigena -infected fruit are sporulating in close proximity to host material, they cannot infect it and we consider this possibility unlikely. Other specific members of Monilinia sp. are discussed below.
The PRA lists certain organisms that APHIS is only able to identify to the genus level and notes that these organisms may prove to have actionable status. One commenter noted this and categorized this as an arbitrary decision by APHIS. The commenter stated that APHIS is incorrect to say that the risk potential of these species should be considered low because APHIS cannot evaluate risk as completely as would be desirable. The commenter appears to suggest that APHIS study these unknown organisms further or that APHIS evaluate risk for genera taken as a whole.
Another commenter requested further information regarding the following fungi, identified only to the genus level, which were listed as being associated with apples in China with actionable or undetermined regulatory status: Cladosporium, Fusarium,
Fusidium, Penicillium, and Psuedocercospora. The commenter stated that these may represent novel species and wanted to know if APHIS went back to original sources or voucher specimens to attempt to confirm the specific identity of these fungi.
Another commenter observed that some pest organisms were only identified to the genus level in the PRA and are thus not included in the evaluation. The commenter particularly cited Drosophila sp. as of potential concern, stating that, though many members of the species only attack and reproduce in damaged fruit, the U.S. apple industry has found that the spotted-wing drosophila ( Drosophila suzukii ) readily attacks and reproduces in intact fruit. The commenter said that this behavior is present in many plant-attacking arthropods and added that the Chinese arthropod fauna is very poorly known and therefore we have no idea of their geographic or host ranges and, consequently, their possible agricultural and ecological impacts.
Another commenter stated that the sooty blotch and flyspeck complex of fungi, which occurs in China, represents a phytosanitary challenge given that most of these fungi have an extremely long incubation period or latent period before colonies become visible on fruit surfaces. Additionally, the commenter identified three species, Zygophiala cylindrical,
Zygophiala qianensis, and Strelitziana mali, which are reported to occur on apples in China but are not included on the pest list.
The same commenter observed that the moth Spulerina astaurota, the lace bug ( Stephanitis ( Stephanitis ) nashi Esaki & Takeya, 1931), and the tortricid moths Acleris fimbriana,
Adoxophyes orana, and Spilonota lechriaspis are listed as associated with fruit in a 2003 Australian review of pests associated with Chinese pears. The commenter said that this association should prove true for apples from China as well and these pests should therefore be added to the pest list.
Another commenter asked why the summer fruit tortix ( Adoxophyes orana ) and the plum fruit moth ( Cydia funebrana ) would not require an approved treatment in regions where these pests are present, as will be required for Oriental fruit fly.
Another commenter stated that, although there are four species of thrips ( Thysanoptera ) listed in the PRA, none were considered to follow the pathway of importation since they only damage leaves. The commenter said that many thrips are known to shelter in the calyxes of fruit and could enter the importation pathway in this manner.
The same commenter said that the PRA did not consider the pear fruit borer ( Pempelia heringii ) as a candidate for risk management based primarily on the fact that it has not been a significant pest in the last 100 years, but that records indicate that it was a pest that bored into the fruit of apples and pears. The commenter stated that a report of this species in Hawaii throws into doubt the restricted host range it is thought to have and therefore the precautionary principle should be applied in including it on the pest list.
One of the risk elements analyzed in the guidelines for risk assessment is damage potential in the endangered area. Considering all available information, the analysis determines whether or not a significant level of damage would be likely to occur in the endangered area ( e.g., more than 10 percent yield loss, significant increases in production costs, impacts on threatened or endangered species). As the commenter notes, reports of significant damage in fruit production as a result of Pempelia heringii infestation are over 100 years old. Apple and pear production in China and Japan are economically important aspects of national agriculture; if significant damage was to occur again, it would have been reported in the literature. While there is some uncertainty regarding the cause of the absence of Pempelia heringii infestations, based on available literature, the potential for damage in the United States is considered low.
The same commenter observed that the oriental red mite ( Eutetranychus orientalis ) was dismissed as a risk by the PRA as there were no records indicated in a “thorough National Agricultural Library, Google Scholar, and PestID database search.” The commenter stated that, to the contrary, there is literature that lists Eutetranychus orientalis as a pest of apple and other rosaceous hosts.
The same commenter stated that the peach fruit moth ( Carposina sasakii ) is treated as not meeting the criteria for spread potential in the PRA, but that the PRA also states that the lack of spread is due to strict quarantine regulations. The commenter went on to say that this is a serious pest in infested regions and should be included for risk management.
We did not claim that the required bagging will serve as sole mitigation for the pests of concern listed in the PRA. The entire systems approach, which comprises a number of requirements working in concert, will provide that mitigation. While we do not possess evidence regarding the efficacy of bagging for apples in particular, the efficacy of bagging as a means of preventing fruit from becoming infested with quarantine insects is well established: The RMD cited several peer-reviewed studies regarding its efficacy. Additionally, we note that bagging is a pest-exclusionary technique that is similar to safeguarding with mesh, tarps, containment structures, and other mitigations APHIS has relied on to prevent pests from following the pathway of fruits for many years.
Fruit bagging has been a required aspect of the systems approach for the importation of pears from China for the past 15 years. This program experiences an extremely low interception rate—15 interceptions in 15 years—with an import volume of about 10,000 MT annually. Although it is not possible to say with absolute certainty, given the structure and past behavior of the Chinese apple industry, which is discussed in detail in the final regulatory flexibility analysis, we expect apples to be imported at a similar rate. Contrary to the third commenter's claim that 15 pest interceptions over a15-year period is troubling, given the time period in question and the level of imports during that time, this interception rate does not call into question the efficacy of bagging, but rather underscores its efficacy.
We proposed to set forth requirements for mitigation measures that would have to take place at registered packinghouses. These measures include a requirement that during the time registered packinghouses are in use for packing apples for export to the continental United States, the packinghouses may only accept apples that are from registered places of production and that are produced in accordance with the regulations, tracking and traceback capabilities, establishment of a handling procedure ( e.g., culling damaged apples, removing leaves from the apples, wiping the apples with a clean cloth, air blasting, or grading) for the apples that is mutually agreed upon by APHIS and the NPPO of China, washing, brushing, spraying with compressed air, and box marking. A commenter said that the inspection procedures for packinghouses do not provide sufficient detail. The commenter said that packinghouse inspections must adequately ensure that leaf removal and washing of apples are conducted according to applicable requirements and added that the packinghouse must address the risk associated with apples originating from nonregistered places of production that may have been processed ahead of the packaging of the apples destined for U.S. markets. Several commenters stated that we should require that Chinese packinghouses handling apples intended for export to the United States not accept commodities destined for any other markets given that the phytosanitary standards required to access non-U.S. markets may be weaker. Another commenter pointed out that the size of the required biometric sample was unspecified. Another commenter stated that packinghouse culling and inspection do not eliminate all lepidopteran and curculionid pests in the United States, so APHIS should not assume that they will do so in China.
As stated previously, APHIS inspectors have the authority to reject consignments that contain contaminants such as leaves and other plant debris, especially if any pests are found to be generally infesting that shipment. As stipulated in § 319.56-3(a), “All fruits and vegetables imported under this subpart, whether in commercial or noncommercial consignments, must be free from plant litter or debris and free of any portions of plants that are specifically prohibited in the regulations in this subpart.” Washing of apples will be required under the regulations, with specific washing procedures set out in the operational workplan. We will also stipulate that packinghouses may not be used for packing apples from non-registered places of production simultaneous to packing apples from registered places of production. Requiring a facility be dedicated for shipping only to the United States is not technically justified if that facility can demonstrate and practice effective methods for identifying and segregating fruit destined for different markets.
Several commenters stated that we should require that Chinese cold storage facilities housing apples intended for export to the United States not accept commodities destined for any other markets given that the phytosanitary standards required to access non-U.S. markets may be weaker.
We prepared an initial regulatory flexibility analysis in connection with the proposed rule regarding the economic effects of the rule on small entities. We invited comments on any potential economic effects and received a number of comments. Those comments are discussed and responded to in detail in the final regulatory flexibility analysis associated with this final rule. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT .
We disagree with the claim that China's prohibition on the importation of apples from the United States was without basis and was motivated by bilateral trade concerns. In 2012, the NPPO of China suspended access for red and golden delicious apples from the State of Washington due to repeated interceptions of three apple pests the NPPO considers significant: Speck rot (caused by Phacidiopycnis washingtonensis ), bull's-eye rot (caused by four species of Neofabraea ), and Sphaeropsis rot (caused by Sphaeropsis pyriputrescens ). In response, APHIS worked with the U.S. apple industry to develop additional safeguarding measures to address China's concerns about these pests. As a result, red and golden delicious apples were permitted to be imported from the United States into China beginning in early November 2014.
Other countries make decisions as to whether to allow the importation of U.S. products only when formally requested. APHIS formally requested that China allow the importation of U.S. apples, and we worked with the U.S. apple industry to address concerns raised by the NPPO of China, resulting in the successful reopening of the Chinese apple market to U.S. apple growers in November 2014. However, APHIS' primary responsibility with regard to international import trade is now, and has been for many years, to identify and manage the phytosanitary risks associated with importing commodities. When we determine that the risk associated with the importation of a commodity can be successfully mitigated, it is our responsibility under the trade agreements to which we are signatory to make provisions for the importation of that commodity. Moreover, under the PPA, our decisionmaking related to allowing or denying the importation of commodities must be based on phytosanitary considerations rather than the goal of reciprocal market access.
In accordance with 5 U.S.C. 604, we have performed a final regulatory flexibility analysis, which is summarized below, regarding the economic effects of this rule on small entities. Copies of the full analysis are available on the Regulations.gov Web site (see footnote 1 in this document for a link to Regulations.gov) or by contacting the person listed under FOR FURTHER INFORMATION CONTACT .
California is the largest market for Washington State apples; any effects of the rule may be borne mainly by Washington and California apple growers. In particular, U.S. apple growers of the Fuji variety, which comprised about 8 percent of U.S. production in 2011, may be more directly affected by an increase in supply because we expect the majority of fresh apples from China will be of the Fuji variety. However, given the relatively small quantity expected to be imported from China, any negative impacts for U.S. small entities will not be significant.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this final rule, which were filed under 0579-0423, have been submitted for approval to the Office of Management and Budget (OMB). When OMB notifies us of its decision, if approval is denied, we will publish a document in the Federal Register providing notice of what action we plan to take.
§ 319.56-72
Fresh apples ( Malus pumila ) from China may be imported into the continental United States from China only under the conditions described in this section. These conditions are designed to prevent the introduction of the following quarantine pests: Adoxophyes orana (Fischer von Röslerstamm), summer fruit tortix; Archips micaceana (Walker), a moth; Argyrotaenia ljungiana (Thunberg), grape tortix; Bactrocera dorsalis (Hendel), Oriental fruit fly; Carposina sasakii Matsumura, peach fruit moth; Cenopalpus pulcher (Canestrini & Fanzago), flat scarlet mite; Cryptoblabes gnidiella (Millière), honeydew moth; Cydia funebrana (Treitschke), plum fruit moth; Euzophera bigella (Zeller), quince moth; Euzophera pyriella Yang, a moth; Grapholita inopinata Heinrich, Manchurian fruit moth; Leucoptera malifoliella (Costa), apple leaf miner; Monilia polystroma van Leeuwen, Asian brown rot; Monilinia fructigena Honey, brown fruit rot; Rhynchites auratus (Scopoli), apricot weevil; Rhynchites bacchus (L.), peach weevil; Rhynchites giganteus Krynicky, a weevil; Rhynchites heros Roelofs, a weevil; Spilonota albicana (Motschulsky), white fruit moth; Spilonota prognathana Snellen, a moth; and Ulodemis trigrapha Meyrick, a moth. The conditions for importation of all fresh apples from China are found in paragraphs (a) through (e) of this section; additional conditions for apples imported from areas of China south of the 33rd parallel are found in paragraph (f) of this section.