Monday, November 19, 2007

Part III

Department of Agriculture Animal and Plant Health Inspection Service

7 CFR Parts 301 and 305 Canker; Movement of From Quarantined Areas; Final Rule

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DEPARTMENT OF AGRICULTURE trees before reaching maturity. The Pest Risk Assessment and Risk aggressive A (Asiatic) strain of citrus Management Analysis Animal and Plant Health Inspection canker can infect susceptible plants To inform the deliberations that led to Service rapidly and lead to extensive economic the proposed rule, we prepared two losses in commercial citrus-producing documents that addressed the risk 7 CFR Parts 301 and 305 areas. is only known to be associated with the interstate movement [Docket No. APHIS–2007–0022] present in the United States in the State of citrus fruit from a quarantined area: of . A pest risk assessment (PRA) and a risk RIN 0579–AC34 The regulations to prevent the management analysis (RMA). The PRA, which was titled ‘‘Evaluation of Citrus Canker; Movement of Fruit From interstate spread of citrus canker are asymptomatic citrus fruit (Citrus spp.) Quarantined Areas contained in §§ 301.75–1 through 301.75–14 of ‘‘Subpart—Citrus Canker’’ as a pathway for the introduction of citrus canker disease (Xanthomonas AGENCY: Animal and Plant Health (7 CFR 301.75–1 through 301.75–17, axonopodis pv. citri),’’ considered all Inspection Service, USDA. referred to below as the regulations). ACTION: Final rule. available evidence associated with The regulations restrict the interstate asymptomatic citrus fruit as a pathway movement of regulated articles from and SUMMARY: We are amending the citrus for the introduction of citrus canker. through areas quarantined because of canker regulations to modify the The PRA concluded that asymptomatic, citrus canker and provide, among other conditions under which fruit may be commercially produced citrus fruit moved interstate from a quarantined things, conditions under which treated with a surface disinfectant and area. We are eliminating the regulated fruit may be moved into, subject to other mitigations is not requirement that the groves in which through, and from quarantined areas for epidemiologically significant 2 as a the fruit is produced be inspected and packing. These regulations are pathway for the introduction and spread found free of citrus canker, and instead promulgated pursuant to the Plant of citrus canker. We first made this are requiring that every lot of fruit Protection Act (7 U.S.C. 7701 et seq.). document available for comment on produced in the quarantined area be On June 21, 2007, we published in the April 6, 2006, when we published a inspected by the Animal and Plant Federal Register (72 FR 34180–34191, notice in the Federal Register (71 FR Health Inspection Service at a Docket No. APHIS–2007–0022) a 17434–17435, Docket No. APHIS–2006– packinghouse operating under a proposal 1 to amend the citrus canker 0045), announcing its availability for compliance agreement and found to be regulations by modifying the conditions comment for 60 days; the comment free of visible symptoms of citrus under which fruit may be moved period was subsequently extended to 90 canker. We are retaining the interstate from quarantined areas. We days. We also submitted it for peer requirement that the fruit be treated proposed to eliminate the requirement review in accordance with the U.S. with a surface disinfectant and the that the groves in which the fruit is Department of Agriculture (USDA) guidelines for peer review developed in prohibition on the movement of fruit produced be inspected and found free of response to the Office of Management from a quarantined area into citrus canker, and instead proposed to and Budget’s peer review bulletin. We commercial citrus-producing States. require that every lot of fruit produced received 19 comments by the end of the These changes will relieve some in the quarantined area be inspected by restrictions on the interstate movement comment period, which we also the Animal and Plant Health Inspection submitted to the peer review panel of fresh citrus fruit from Florida while Service (APHIS) at a packinghouse maintaining conditions that will help members for their consideration.3 We operating under a compliance prevent the artificial spread of citrus carefully considered the comments of agreement and found to be free of canker. the public and peer reviewers, and visible symptoms of citrus canker. We made revisions to the analysis based on DATES: Effective Date: November 19, proposed to retain the requirement that concerns they raised. The revisions did 2007. the fruit be treated with a surface not change the conclusions of the PRA; FOR FURTHER INFORMATION CONTACT: Mr. disinfectant and the prohibition on the the revised version of the PRA was Stephen Poe, Senior Operations Officer, movement of fruit from a quarantined provided with the proposed rule. Emergency and Domestic Programs, area into commercial citrus-producing In light of the comments by the public Plant Protection and Quarantine, States. and peer reviewers, it became clear that APHIS, 4700 River Road Unit 137, We solicited comments concerning additional analysis was necessary to Riverdale, MD 20737–1231; (301) 734– our proposal for 30 days ending July 23, apply the conclusions of the PRA to the 4387. 2007. We subsequently reopened and situation in Florida. In order to apply SUPPLEMENTARY INFORMATION: extended the deadline for comments the conclusions of the PRA, we needed until August 7, 2007, in a document to extend its application to evaluate Background 4 published in the Federal Register on methods by which fruit could be produced, treated, inspected, packaged, Citrus canker is a plant disease caused July 27, 2007 (Docket No. APHIS–2007– and shipped without resulting in the by the bacterium Xanthomonas 0022, 72 FR 41239). We received 72 axonopodis pv. citri (referred to below comments by the close of the comment 2 We use the term ‘‘epidemiologically significant’’ as Xac) that affects plants and plant period. They were from producers, parts, including fresh fruit, of citrus and to refer to minimum conditions required for disease exporters, researchers, and transmission. citrus relatives (Family Rutaceae). Citrus 3 representatives of State governments. The original PRA and the comments we canker can cause defoliation and other They are discussed below by topic. received on it can be viewed at http:// serious damage to the leaves and twigs www.regulations.gov/fdmspublic/component/main of susceptible plants. It can also cause ?main=DocketDetail&d=APHIS–2006–0045. 1 To view the proposed rule, the supporting 4 Given the practical difficulties in ensuring that lesions on the fruit of infected plants, analyses, and the comments we received, go to only asymptomatic fruit enters interstate commerce which render the fruit unmarketable, http://www.regulations.gov/fdmspublic/component/ under any regulatory strategy, we refer here to host and cause infected fruit to drop from the main?main=DocketDetail&d=APHIS–2007–0022. fruit in general.

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spread of citrus canker to commercial • Large quantities of fresh citrus fruit distribution of all types and varieties of citrus-producing areas. (Commercial shipped from regions with Xac have not citrus fruit to States other than citrus-producing areas are listed in resulted in any known outbreaks of commercial citrus-producing States, § 301.75–5 of the regulations and are citrus canker disease. with mitigations conducted at referred to in this document as Nevertheless, the RMA concluded packinghouses operating under commercial citrus-producing States. that the evidence is not currently compliance agreements. Those Those States, listed in § 301.75–5(a), are: sufficient to support a determination mitigations are the use of an approved American Samoa, Arizona, California, that fresh citrus fruit produced in a Xac- disinfectant for all fruit and APHIS Florida, Guam, Hawaii, Louisiana, infested grove cannot serve as a phytosanitary inspection. Northern Mariana Islands, Puerto Rico, pathway for the introduction of Xac into We received several comments on the Texas, and the U.S. Virgin Islands.) new areas. Therefore, the RMA overall level of risk associated with the To address the considerations evaluated several packinghouse- movement of commercially packed described above, APHIS prepared the centered risk management options for citrus from a citrus canker quarantined RMA, which was titled ‘‘Movement of the interstate movement of fresh area, as well as our selection of Option commercially packed fresh citrus fruit commercially packed citrus fruit from 4. These comments have not led us to (Citrus spp.) from citrus canker regions infested with citrus canker to change our determination that Option 4 (Xanthomonas axonopodis pv. citri) regions without the disease. These is the most appropriate option to disease quarantine areas, March 2007.’’ packinghouse-centered risk implement. The RMA that we are We made the RMA available for management options were evaluated to making available with this final rule comment along with the proposed rule.5 determine whether they provide an contains revisions based on the The RMA was also submitted for peer appropriate level of phytosanitary comments we received on the proposed review, which occurred concurrently protection without the resource rule and the comments we received with the public comment period for the constraints and other practical through the peer review process, but its proposed rule.6 The RMA analyzed the considerations that make it difficult to overall conclusion is the same. potential of fresh commercially packed maintain the grove-centered regulatory Accordingly, this final rule implements citrus fruit and associated packing approach in Florida. The risk Option 4. (We are making some changes material to serve as a pathway for the management options evaluated were: • to the regulatory requirements introduction and spread of citrus canker Option 1: Allow unrestricted associated with the implementation of into new areas. It also identified and distribution of all types and varieties of Option 4. These changes are discussed evaluated options for regulating the commercially packed citrus fruit to all later in this document.) interstate movement of citrus fruit from U.S. States. • Some commenters believed that the quarantined areas with the goal of Option 2: Allow distribution of all types and varieties of commercially evidence presented in the RMA reducing the potential for citrus canker warranted the selection of Option 2, introduction and spread. The packed citrus fruit to all U.S. States, subject to packinghouse treatment with which would have allowed the recommendations in the RMA served as distribution of citrus fruit to all States, the basis for the proposed rule. APHIS-approved disinfectant and APHIS inspection of finished fruit that subject to packinghouse treatment with To develop the RMA, we reviewed APHIS-approved disinfectant and available evidence regarding the biology has completed the packinghouse culling, washing, disinfection, and APHIS inspection of finished fruit. and epidemiology of Xac and the These commenters stated that it was management of citrus canker disease. grading processes. • Option 3: Allow distribution of all extremely unlikely that the The RMA concluded that the circumstances necessary for the introduction and spread of Xac into types and varieties of commercially packed citrus fruit (except ) in movement of commercially packed fresh other commercial citrus-producing citrus fruit to result in the introduction States through the movement of U.S. States except commercial citrus- producing States. Allow distribution of and spread of Xac into other commercially packed fresh citrus fruit commercial citrus-producing States from quarantined areas is unlikely commercially packed tangerines to all U.S. States, including commercial would ever occur. because: One commenter stated that the • Fresh citrus fruit is produced and citrus-producing States. Require decision to allow the movement of harvested using techniques that reduce packinghouse treatment of all such regulated fruit from a citrus canker the prevalence of Xac-infected fruit; citrus fruit with APHIS-approved • Citrus fruit is commercially packed disinfectant and APHIS inspection of quarantined area only into States other using techniques that reduce the finished fruit (all types and varieties) for than commercial citrus-producing prevalence of infected or contaminated citrus canker disease symptoms. States, rather than into all States, was fruit, including disinfectant treatment • Option 4: Allow distribution of all based on politics rather than on science. for epiphytic contamination; types and varieties of commercially One commenter stated that no Florida • For a successful Xac infection that packed citrus fruit in U.S. States except citrus fruit infected with citrus canker results in disease outbreaks to occur, an commercial citrus-producing States and has ever been found in a commercial unlikely sequence of events would have require packinghouse treatment of citrus citrus-producing State under the current to occur; fruit with APHIS-approved disinfectant regulations and that, at the commenter’s • Reports of citrus canker disease and APHIS inspection of finished fruit packinghouse, not a single piece of fruit outbreaks linked to fresh fruit are (all types and varieties) for citrus canker with citrus canker had been found by absent; and disease symptoms. any inspectors or employees during the • Option 5: Leave the current last growing season. 5 The RMA is available on the Regulations.gov regulations for the interstate movement One commenter noted more generally Web site and in our reading room (see ADDRESSES of citrus fruit from citrus canker that citrus canker has not been found above) and may be obtained from the person listed quarantined areas in place and outside Florida since the disease was under FOR FURTHER INFORMATION CONTACT. 6 The peer review materials for the RMA may be unchanged. first detected there, and stated that more viewed at http://www.aphis.usda.gov/peer_review/ We proposed to implement Option 4. certainty than uncertainty exists peer_review_agenda.shtml. This option would have limited regarding the risk of commercially

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packed citrus fruit as a viable pathway States other than commercial citrus- One commenter asked why APHIS for citrus canker. producing States under the conditions allows fruit to be exported from the Another commenter noted that the described in the proposed rule. While quarantined area into the citrus- PRA stated the following in its APHIS has concluded that commercially producing areas of Europe, given that executive summary: ‘‘The combination packed citrus fruit is an unlikely we proposed to prohibit the distribution of conditions necessary for introduction pathway for the introduction and spread of fruit from quarantined areas into are so difficult to achieve that the of citrus canker, the remaining commercial citrus-producing States. likelihood of such occurrence is greater uncertainty about the level of risk Other commenters asked that we allow than the baseline exposure represented associated with the movement of citrus the interstate movement of fruit from by unregulated pathways. The fruit from a quarantined area has led us quarantined areas into commercial conclusions of the evaluation are to maintain the prohibition on the citrus-producing States under reinforced by a strong record of movement of citrus fruit into conditions similar to those required by empirical data from experience and commercial citrus-producing States. the European Union (EU) for the interceptions.’’ One commenter supplied a report that importation of citrus fruit into the EU. We acknowledge the efforts of the provided initial data demonstrating that APHIS certifies U.S. plant products Florida citrus industry to put safeguards transmission of Xac from infected fruit for export according to the conditions in place against citrus canker placed directly under highly susceptible set by the importing country for the infestation. The proposed rule seedlings does not occur. exportation of those products from the recognized the effectiveness of those The research (which can be viewed at United States. The EU’s requirements safeguards by providing for the http://www.regulations.gov/fdmspublic/ for the importation of citrus fruit apply interstate movement to States other than component/main?main=Document to all areas where citrus canker is commercial citrus-producing States of Detail&d=APHIS–2007–0022–0053) is present, not just in the United States but any lot of citrus fruit that is suggestive; when it is completed, it will in other countries whose citrus commercially packed, treated with help better determine whether areas are affected by citrus APHIS-approved disinfectant, and fruit can serve as a pathway for the canker. inspected by APHIS and found to be introduction of citrus canker to The EU import requirements involve free of visible canker lesions. commercial citrus-producing States certification of grove freedom from The RMA concludes that outside the quarantined area. We citrus canker and are similar to, but less commercially packed fresh citrus fruit is encourage interested parties to make restrictive than, the requirements that an unlikely pathway for the research on this issue available to us. were in the regulations before the introduction and spread of Xac and that Two commenters stated that APHIS’ publication of this final rule. For a phytosanitary inspection ensures, with treatment of the risk associated with reasons discussed in the RMA, we do high confidence, that few shipped fruit citrus canker was inconsistent with its not consider these requirements to be would have symptoms of citrus canker treatment of the risk associated with sufficient to allow the movement of fruit disease. However, the model in other plant pests. For example, one of from citrus canker quarantined areas Appendix 1 to the RMA indicates the the commenters stated, the evidence is into commercial citrus-producing States potential for some commercially packed clear that the interstate movement of at this time. We will continue to review fruit with visible canker lesions to be nursery stock is a pathway for the long- the available science and will update shipped to commercial citrus-producing distance spread of P. ramorum, but the regulations if necessary. States. That potential for such fruit to APHIS’ regulations continue to allow Two commenters stated that Option 3, reach commercial citrus-producing high-risk nursery stock to move to all which would have allowed the States, coupled with the aforementioned States, under specified conditions. The unlimited distribution of tangerines uncertainty regarding fruit as a pathway, commenter cited APHIS’ actions with subject to treatment and APHIS led to the determination that the respect to the light brown apple moth as inspection, should be implemented. additional mitigation of prohibiting another example. One commenter stated that canker finds distribution to commercial citrus- The provisions governing the have been few and far between, if the producing States was required. If, in the movement of regulated articles for each disease has been found at all, on some future, evidence is developed to support pest for which APHIS maintains varieties of . Another stated a determination that commercially quarantine requirements are the result that mandarin varieties are the least packed citrus fruit (both symptomatic of separate considerations of the susceptible to citrus canker, and that the and asymptomatic) is not an available science and the risk posed by commercial citrus-producing States of epidemiologically significant pathway the plant pest in question. We make our California and Texas are important for the introduction and spread of citrus determinations of risk based on, among markets for producers of this fruit. canker, we would undertake rulemaking other things, the likelihood that a pest Tangerines are generally grouped in to amend our regulations accordingly. will follow a specific pathway, the the species Citrus reticulata and are Under section 412(a) of the Plant economic and environmental value of widely regarded as less susceptible to Protection Act (7 U.S.C. 7712(a)), the resources that could be damaged by the citrus canker disease than other Secretary of Agriculture may prohibit or pest, and the likelihood of introduction commercially grown Citrus species. But restrict the movement in interstate of the pest into an unaffected area. Our many of the ‘‘tangerine’’ varieties grown commerce of any plant or plant product choice of regulatory approach is based in Florida are hybrids of C. reticulata if the Secretary determines that the on, among other things, the likelihood with other more susceptible Citrus prohibition or restriction is necessary to that the mitigations available to us will species. Clearly, tangerines in Florida prevent the dissemination of a plant be sufficient to prevent the introduction are not immune to citrus canker, as pest or noxious weed within the United or spread of a plant pest. We have APHIS records indicate that, during the States. Based on information provided determined that the level of protection 2005–2006 growing season grove in the PRA and RMA, we have against the interstate spread of citrus surveys, Xac was detected on 274 determined that it is not necessary to canker that will be provided by the samples from tangerine, , and prohibit the interstate movement of regulations as amended by this final groves. APHIS pest interception citrus fruit from a quarantined area into rule is appropriate. data indicate that between 1985 and

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2006, Xac was intercepted 632 times on Some commenters disagreed with our States, citrus canker is not likely to C. reticulata fruit. The level of determination that prohibiting the spread through natural means (such as susceptibility was expressed as a distribution of citrus fruit from a through storms) from Florida to a State continuum across ‘‘tangerine’’ varieties quarantined area into commercial that is not a commercial citrus- rather than as a discrete immunity for citrus-producing States would be an producing State and then to a all varieties. This creates a regulatory effective mitigation. Commenters commercial citrus-producing State. problem when an overlap occurs in the holding this view stated that the illegal While it is correct that the movement of level of susceptibility expressed by, for movement of citrus fruit harboring plants for planting presents a high risk example, a more susceptible tangerine citrus canker from a quarantined area to of spreading citrus canker from a variety and a more resistant a commercial citrus-producing State quarantined area, the regulations nontangerine citrus variety. Sufficient may be expected through current already contain a prohibition on the evidence does not exist to exclude commercial channels; they cited the movement of plants for planting; tangerines from regulations applicable movement of Spanish from currently, only calamondin and to other Florida citrus varieties. We are Georgia to Florida through retailer plants are allowed to move making no changes to the proposed rule distribution when such movement was interstate from the quarantined area, in response to these comments. prohibited as one example of the and those plants must be produced Several commenters supported potential for incorrect distribution. under conditions designed to prevent Option 4 but asked APHIS to continue Another commenter cited the discovery their infection with citrus canker. As to examine the scientific evidence with of Florida fruit in commercial citrus- mentioned earlier, we have determined a view toward allowing unlimited producing States as a result of that it is unlikely that the movement of distribution of fruit moved interstate distribution mistakes. commercially packed citrus fruit is an from areas quarantined for citrus canker These commenters also stated that the epidemiologically significant pathway at some future time. potential for the movement of Florida for the spread of citrus canker. We will continue to examine citrus by tourists and visitors from The proposed rule included scientific evidence regarding whether nearby States into commercial citrus- requirements that boxes or other commercially packed citrus fruit (both producing States should also be taken containers of fruit moving interstate with and without visible canker lesions) into account, and that excluding from a quarantined area include a is an epidemiologically significant shipments to buffer States would reduce limited permit mark as well as the statement indicating that the fruit is not pathway for the introduction and spread the risk that this movement poses to to be distributed into a commercial of citrus canker. If, in the future, commercial citrus-producing States. citrus-producing State. This evidence is developed to support a One commenter stated that the history requirement (which applies to mail- determination that commercially packed of citrus disease movement such as order and gift-pack shipments as well as citrus fruit is not an epidemiologically citrus canker and citrus greening into truck shipments) will help to prevent significant pathway for the introduction Florida shows the high risk of inadvertent movement of citrus from and spread of citrus canker, we would movement by plant or by fruit from quarantined areas into a commercial undertake rulemaking to amend our other citrus-growing countries. In these citrus-producing State. To strengthen regulations accordingly. cases the initial infections were in urban areas, but movement to production areas the protection provided by the limited Some commenters proposed other was undetected until an epidemic was permit requirement, we are also adding options to allow the movement of fruit finally observed. a requirement in this final rule that the from quarantined areas. One commenter One commenter also stated that we limited permit mark and the stated that fruit from groves that are free had not addressed mail-order shipment distribution statement appear on any of citrus canker and that are 1,500 feet or gift-pack movement of citrus from shipping documents accompanying or farther from an affected grove should Florida. boxes or other containers in which fruit be allowed to move fruit to commercial These commenters proposed that we is moved interstate. citrus-producing States. limit the distribution of fruit from citrus To ensure that regulated parties It has been our experience in the State canker quarantined areas to other States comply with distribution restrictions, of Florida that citrus canker can spread in addition to the commercial citrus- APHIS routinely monitors wholesalers more than 1,500 feet in stormy producing States, thus creating a ‘‘buffer and fresh fruit markets in commercial conditions. We recognize that citrus zone’’ around the commercial citrus- citrus-producing States and monitors canker-free areas may exist adjacent to producing States. The buffer zones distribution routes that are bound for infected areas, but implementing the proposed by the commenters varied: commercial citrus-producing States to commenter’s suggestion would require • One commenter suggested that only ensure that Florida citrus fruit does not grove certification programs similar to States east of the Mississippi River unlawfully enter those States. This those in place prior to the publication should be eligible to receive fruit moved monitoring is conducted primarily by of this final rule. We have determined interstate from quarantined areas. APHIS’ Smuggling, Interdiction, and that certification of fruit for interstate • Two commenters suggested that Trade Compliance program. movement at the packinghouse level only States in the northern tier of the If we find Florida citrus in a rather than at the grove level will ensure United States and east of the Mississippi commercial citrus-producing State, we an appropriate level of phytosanitary River should be eligible to receive such will trace the product back to its security; would be more reliable and fruit. distributor and its origin in Florida. We less easily circumvented than the • Two others suggested a buffer zone will investigate violations (through preharvest grove survey required by of all the States surrounding the APHIS’ Investigative and Enforcement Option 5; would be consistent with the commercial citrus-producing States. Services) and may seek penalties against risk associated with citrus canker and We do not agree that a buffer zone, any distributor that moves Florida citrus commercially packed fruit from Florida; such as these commenters suggest, is to commercial citrus-producing States. and would be easier and potentially less appropriate or necessary. Due to the We may seize the prohibited products costly to implement and enforce than a geographic separation between Florida and destroy them or ensure they are grove-centered system of mitigations. and other commercial citrus-producing moved from the area of concern. We

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will conduct surveillance on other the introduction and spread of Xac into on sound science. To fulfill this methods of sale such as Internet sales other commercial citrus-producing mission, we use all the scientific and gift-pack shipments to ensure that States through the movement of evidence that may be brought to bear on the fruit is not advertised as being commercially packed fresh citrus fruit is an issue, not just studies published in available for delivery to commercial unlikely and that the mitigations of peer-reviewed journals. Observations citrus-producing States. We will also treatment and APHIS inspection are based on APHIS’ experience, survey and provide outreach to retailers and highly effective, have led us to pest detection data, and preliminary wholesalers who are moving products to determine that a buffer zone to address experimental results can all provide help prevent any inadvertent movement such movement is unnecessary. valuable information to inform a of citrus from a quarantined area into a regulatory decision, and we have used Scientific Evidence Used in the PRA and commercial citrus-producing State. them in the PRA and RMA when RMA The packinghouse measures of appropriate. Having said that, the vast disinfection and APHIS inspection We received several general majority of the sources cited in the PRA ensure that even if a given shipment comments on the scientific evidence we and RMA have been peer-reviewed, as were illegally moved to a commercial used to make our determinations in the have both the PRA and RMA citrus-producing State, the shipment PRA and RMA. One commenter stated themselves. would have a low likelihood of that the conclusion reached by the RMA Comments on specific studies we containing fruit with the potential to is in part based on the lack of evidence cited in the RMA and PRA are discussed cause an outbreak of citrus canker that citrus fruit could play a role in the later in this document. disease. introduction of citrus canker in new The peer review for the RMA was As mentioned earlier, the RMA areas, but that this lack of evidence is conducted concurrently with the examined four options for allowing the a consequence of the lack of scientific comment period for the proposed rule. interstate movement of citrus fruit from studies and is not based on scientific One commenter stated that stakeholders a citrus canker quarantined area under data; this commenter suggested that we should have the opportunity to review a packinghouse-centered approach. Of evaluate the risks further using fruit the peer reviewers’ comments when those four options, we determined that produced subject to the regulations that submitting their own comments on this Option 4 was most appropriate, based were in place before the publication of document. on the available scientific evidence, this final rule. Another commenter We appreciate the commenter’s which indicates that fruit subject to suggested an extensive list of concerns. APHIS had already provided commercial packing, treatment, and experimental data that the commenter for peer review of and public comment APHIS inspection will be unlikely to believed were necessary to prove that on the PRA, which informed the serve as a pathway for the introduction the introduction and spread of Xac into development of the RMA. In accordance or spread of citrus canker. other commercial citrus-producing with the Office of Management and We recognize that individual States through the interstate movement Budget’s bulletin on peer review, we are consumers may move fruit from Florida of commercially packed fresh citrus also making all the materials associated into States other than commercial fruit from a quarantined area is unlikely. with the peer review, including the peer citrus-producing States and then One commenter stated that this reviewers’ comments, available at subsequently move that fruit into program, which the commenter http://www.aphis.usda.gov/peer_review/ commercial citrus-producing States. characterized as precedent-setting, peer_review_agenda.shtml. The However, such movement could have requires a much more solid foundation conclusion of the RMA did not change occurred under the regulations in place of science and process affirmation than as a result of the peer review, which was before the publication of this final rule has been developed to date. Other generally favorable. as well; APHIS does not have the commenters stated that not enough of One commenter included a late regulatory infrastructure to monitor the evidence we used in developing the comment on the PRA as a reference, interstate movement of fruit by RMA had been published in peer- stating that APHIS had not made individual consumers. Additionally, reviewed scientific journals and that we appropriate changes to the PRA based even with a buffer zone in place, had relied too much on preliminary on the comment. tourists and visitors would often travel research in making our determinations. We reviewed the comment that the across multiple States to reach their We used the best scientific evidence commenter included when we destinations, meaning that a buffer zone available to develop the PRA and the developed the revised version of the would not be highly effective at RMA, and we have detailed extensively PRA. We addressed all the substantive eliminating this consumer movement. how this evidence supports the points raised by that comment in the For tourists and visitors, as well as for conclusions we present in those revised version of the PRA published local residents who routinely move documents. It is important to note that, with the proposed rule. Many of the between commercial citrus-producing based on the available evidence, we did points raised by that comment had been States and other States, the distance not conclude that commercially packed previously raised in other comments between the borders of commercial citrus fruit could not serve as a pathway submitted on the PRA during the citrus-producing States and the citrus- for the introduction and spread of Xac, comment period. producing areas within those States acts but rather that it was unlikely that As discussed earlier, the PRA as a buffer as well, further decreasing commercially packed citrus fruit serves concluded that asymptomatic, the risk associated with such movement. as an epidemiologically significant commercially produced citrus fruit Finally, the volume of such movement pathway. That is why this final rule treated with a surface disinfectant and is extremely low when compared with prohibits the distribution of such fruit to subject to other mitigations is not the volume of commercial movement of commercial citrus-producing States. epidemiologically significant as a fruit, making the risk of citrus canker The Plant Protection Act charges us pathway for the introduction and spread establishment in commercial citrus- with ensuring that our decisions of citrus canker. However, in order to producing States through this scenario affecting imports, exports, and interstate apply the conclusions of the PRA, we highly unlikely. These factors, movement of plants and plant products determined that we needed to extend its combined with our determination that that we regulate under the Act are based application to evaluate methods by

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which fruit could be produced, treated, One commenter stated that in other of fruit must be inspected by an APHIS inspected, packaged, and shipped countries such as Argentina that ship inspector for visible canker lesions. without resulting in the spread of citrus fruit to citrus-producing countries in While growers are not required to canker to commercial citrus-producing Europe, strict guidelines are followed practice measures that would reduce the areas. Accordingly, the RMA addresses that include field inspections and the prevalence of citrus canker in their fruit, the risk associated with all planting of wind breaks between and packinghouses are not required to commercially packed fruit; the RMA’s orchards that minimize wind velocity perform their own culling process to recommendations have served as the and subsequent dispersal of inoculum. remove fruit with visible canker lesions, basis for the Secretary’s determination The commenter stated that these the regulations promulgated in this final that it is not necessary to prohibit the countries realize that inspection of rule still provide them with a strong interstate movement of citrus fruit from ‘‘finished’’ fruit in the packinghouse incentive to do so, since lots of fruit that a quarantined area into States other than alone is not enough to guarantee the fail APHIS inspection will not be commercial citrus-producing States shipment of disease-free fruit. eligible for interstate movement. under the conditions described in the One commenter stated that the Additionally, packinghouse culling for proposed rule. Therefore, specifically objective of a rule addressing Florida’s blemished fruit of any kind is already a addressing comments on the PRA is situation should be to prevent citrus standard business practice, and field unnecessary for the purposes of this canker from being introduced into management programs that include the rulemaking. disease-free areas in the United States; use of copper sprays and field sanitation such a rule should not be designed with are already available to producers. The Packinghouse-Centered Approach the primary objective of allowing The purpose of the APHIS inspection and the Current Regulations shipments of fresh fruit from canker- at the packinghouses is to ensure that In evaluating the risk associated with affected areas. This commenter stated fruit moved interstate is free of visible asymptomatic fruit, the PRA assumed that the building blocks of premises and canker lesions, and to prohibit the that the citrus fruit in question was assumptions set forth in the proposed interstate movement of fruit that is not commercially produced under a specific rule and the RMA create risk rather than free of those lesions. From each lot of set of pest management measures. The develop protective barriers. fruit intended for interstate movement, RMA, while recognizing that effective The regulations promulgated in this APHIS will inspect a quantity that is pest management measures for Xac are final rule include protective barriers sufficient to detect, with a 95 percent available to private and commercial against the introduction of citrus canker level of confidence, any lot of fruit growers and are normal production into other citrus-producing areas: containing 0.38 percent or more fruit practices for many of these growers, Treatment with a surface disinfectant, with visible canker lesions. Lots of fruit APHIS inspection, and a prohibition of does not assume that measures in the that fail inspection will not be allowed the movement of citrus fruit from a grove are mandatory. Instead, the RMA to enter interstate commerce. quarantined area into commercial A packinghouse-based inspection can focuses on treatment with an APHIS- citrus-producing States. We have ensure an appropriate level of approved disinfectant at the determined that these barriers provide phytosanitary security and will be easier packinghouse and APHIS inspection of an appropriate level of protection with to implement and enforce than the grove fruit to be moved interstate. The regard to the movement of citrus fruit certification system in place before the recommendations in the RMA served as from areas quarantined for citrus canker. publication of this final rule. Because it the basis for the proposed rule. The grove certification requirement in focuses on the end product, a The regulations in place at the time place prior to the publication of this packinghouse-based inspection will be the proposed rule was published final rule and the APHIS packinghouse more reliable and less easily required that fruit moved interstate inspection required under this final rule circumvented than the preharvest grove originate in a grove that was found by are not dissimilar in their approach to survey that has been required in the an inspector to be free of citrus canker preventing the interstate movement of regulations. A packinghouse-based no more than 30 days before harvest fruit with visible canker lesions. Under inspection is also consistent with the (with additional requirements for the regulations in place before the risk associated with citrus canker and limes), in addition to treatment of publication of this final rule, none of the commercially packed fruit from Florida. vehicles, equipment, and other articles grove-centered measures cited by the In addition, a phytosanitary that are used on the grove and treatment commenters (copper sprays, designation packinghouse inspection creates a of the fruit itself. and exclusion of infected trees, and performance standard for packed fruit Several commenters objected to field culling of fruit) were required. that allows citrus producers greater APHIS moving away from the grove Rather, growers were required to flexibility to determine the most inspection approach and to the fact that demonstrate that their groves were free efficient and effective means of we did not propose to require the use from citrus canker, on the basis of an producing a compliant product. of the commercial production practices inspection. In order to be found free Our choice of a packinghouse-based described in both the PRA and the from citrus canker, and thus have fruit APHIS inspection as a means to prevent RMA. These commenters stated that, from their groves be eligible for the fruit with visible canker lesions from under the proposed rule, measures such interstate market, growers had being moved interstate, rather than as copper sprays, designation and incentives to employ the grove-centered requiring specific grove and exclusion of infected trees, field culling measures described in the PRA and packinghouse practices to ensure the of fruit, and packinghouse culling of RMA and mentioned by the production of fruit free of visible canker fruit were all voluntary, and their commenters. lesions, is consistent with the effectiveness was unknown. The Instead of a grove inspection, this recommendations of the 1997 commenters expressed concern that not final rule requires an inspection of the Presidential/Congressional Commission requiring these measures would finished fruit at the packinghouse, on Risk Assessment and Risk increase the risk associated with citrus which must operate under a compliance Management. The commission fruit moved interstate from a agreement and treat fruit with an recommended that agencies use quarantined area. approved surface disinfectant. Every lot alternatives to command-and-control

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measures that dictate the use of specific rule, the fruit will be subject to an Several commenters stated that these technologies, where applicable (CRARM additional APHIS inspection separate surface disinfectant treatments may not 1997), in order to encourage flexibility from any field inspection and culling or be 100 percent effective, citing various in the choice of risk management packinghouse culling that may occur. reports that indicated that bacteria alternatives. Any lot that fails APHIS inspection will could be recovered from citrus fruit that One commenter characterized the not be approved to move for interstate had been treated with sodium approach of the proposed rule as a commerce. Given that, if there is a hypochlorite or SOPP, including reports control point approach, and stated that financial advantage to being able to by Verdier (2006) and Golmohammadi in the past APHIS has applied control supply fresh citrus to the interstate (2007) and a newspaper article reporting point approaches only to quarantine market, producers and packinghouses in on a lecture by Gottwald in which he treatments that are able to demonstrate quarantined areas are likely to employ presented unpublished preliminary a probit 9 level of effectiveness. measures and processes that will allow results. With regard to the last of these, The probit 9 standard (99.997 percent them to supply fruit free of visible two commenters requested that we mortality) applies to treatments for canker lesions for APHIS inspection. provide information about the followup insect pests such as fruit flies, not to studies mentioned in the article. treatment of pathogens. In any case, the Treatments and Surface Contamination As stated in the RMA, the surface probit 9 standard is not applicable for With Xac disinfectant treatments approved by the surface disinfectant treatment and The regulations require all fruit APHIS reduce numbers of Xac cells to packinghouse-based APHIS inspection moved interstate from an area low or undetectable levels, but do not that we are requiring. Scientific quarantined for citrus canker to be necessarily provide complete evidence indicates that both of these treated in accordance with § 301.75– eradication. The evidence cited by the measures are highly effective. 11(a). This paragraph has included two RMA does demonstrate that the One commenter stated that the PRA treatments: Thorough wetting for at least treatments allowed under the rule and RMA appeared to imply that 2 minutes with a solution containing substantially reduce bacterial packinghouse studies conducted to date 200 parts per million (ppm) sodium populations, including Xac, found on were based upon fruit with known hypochlorite, with the solution the surface of citrus fruit to the extent levels of contamination with Xac. The maintained at a pH of 6.0 to 7.5; or practicable using surface disinfectant commenter asked how the packinghouse thorough wetting with a solution treatments currently registered for use inspection process would achieve the containing sodium-o-phenyl phenate in the United States on raw and results described in the RMA without (SOPP) at a concentration of 1.86 to 2.0 vegetables. grove inspections and without the percent of the total solution, for 45 Recovery of Xac from fruit after ability to determine the infection seconds if the solution has sufficient surface disinfectant treatment does not pressure. The commenter also asked soap or detergent to cause a visible demonstrate that the treatment is how the proposed measures can be ineffective. Microbial detection or foaming action or for 1 minute if the effective without knowing the recovery tests simply measure the solution does not contain sufficient soap magnitude of the hazard, as expressed presence or absence of the organism in to cause a visible foaming action. by the proportion of infected fruit. a sample and do not enumerate or Both of the packinghouse measures One commenter noted that measure the difference between the pre- that we are requiring in this final rule disinfectants are only effective if the and post-treatment bacteria population are effective regardless of infection active ingredient is not degraded. The levels or infectivity. The treatments in pressure. The surface disinfectant commenter gave the example that the regulations are consistently reported treatments approved by APHIS reduce sodium hypochlorite is degraded by as dramatically reducing Xac numbers of Xac cells to low or sunlight and organic matter. populations on the surface of fruit, if not undetectable levels. The APHIS We agree with the commenter’s point eliminating them entirely. For example, packinghouse-based inspection is that it is important to ensure that the Verdier (2006), cited by the sufficient to detect, with a 95 percent treatment is conducted properly. APHIS commenters, measured the pre- and level of confidence, any lot of fruit regularly monitors the treatment of fruit post-treatment levels in the wash containing 0.38 percent or more fruit to ensure that the disinfectant agent is solution and found that the bacteria with visible canker lesions. In other at the proper concentration and, in the population level was reduced 99.8 words, if the infection pressure is higher case of sodium hypochlorite, pH, thus percent from an average of 39.4 colony- than 0.38 percent of the fruit, it is 95 ensuring the effectiveness of the forming units (cfu)/mL on untreated percent likely that the lot will be treatment. Under this final rule, we will controls to an average of 0.06 cfu/mL on rejected from interstate commerce. conduct monitoring under conditions treated fruit. Two commenters cited findings of specified in the compliance agreements The information from Gottwald (2006) canker symptoms on fruit exported from with packinghouses. the commenters cite has not been Argentina and Uruguay to Spain in In this final rule, we are amending the published, and the followup studies stating that symptomatic fruit will often treatment regulations to require fruit to referred to in news reports are currently pass through the packinghouse process. be treated at a commercial packinghouse being completed. We are not able to These commenters stated that the price whose owner operates under a obtain the unpublished data that have growers and packers are receiving for compliance agreement. Previously, the been collected to this point. We will citrus is what drives the quality of the regulations had required that treatment review the Gottwald information when citrus shipped, and that with low prices, be performed either in the presence of it becomes available in final form. It is low-quality fruit, such as those with an inspector or at a facility whose owner important to note again that the canker, are more likely to be introduced operates under a compliance agreement recovery of some bacteria after treatment into distribution channels. under § 301.75–7(a)(2); this change will is not inconsistent with treatment being We agree that, in general, price helps reflect the fact that all fruit intended for highly effective at reducing Xac to determine the quality of fruit interstate movement must be treated at population levels, as described earlier. supplied. However, under the a commercial packinghouse under this Another commenter, referring to a regulations established by this final final rule. study by Brown and Schubert (1987)

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that the RMA cited, stated that the from trees, with a bacterial suspension provisions of this subpart. We do not study’s use of Xanthomonas campestris of 106 cfu/mL; no bacteria were typically regulate the movement of the pv. vesicatoria as a proxy for X. recovered after 5 days at room other articles cited by the commenters axonopodis pv. citri in assessing the temperature under laboratory conditions under the current regulations because efficacy of SOPP was not appropriate, (Belasque and Rodriguez Neto 2000). populations of Xac on such articles are because the behavior of closely related Epiphytic bacteria do not multiply in very unlikely to infect mature citrus bacteria may be very different. water on leaf surfaces or on dry leaves fruit. The use of a proxy in efficacy testing (Timmer et al. 1996). Graham et al. Two commenters were concerned is not unusual; for example, the (2000) found that Xac survived for 48 to about the possibility that canker- Environmental Protection Agency (EPA) 72 hours on a variety of inanimate infected fruit could contaminate requirements for testing the efficacy of surfaces in sun or shade, respectively. packinghouse equipment with Xac. One disinfectants allow the use of a proxy. Additionally, there is no authenticated commenter stated that packinghouse A proxy organism was used in this record of movement of diseased fruit as equipment needs to be disinfected if study because the study was conducted the origin for a citrus canker disease citrus canker is found in a lot run on in a model packinghouse. It is difficult outbreak, which is especially suggestive that equipment. The other expressed a to experiment with quarantine plant given the brisk global trade in such fruit specific concern about contamination of pathogens in the field because of the and the likely presence of some level of existing wounds in fruit and stated that need to provide safeguards against their epiphytic bacteria on many fruit that is surface disinfestation cannot be spread. While the bacteria in question exported from citrus canker-affected continuously done during the are not identical, SOPP has a broad areas. commercial packing of fruit where both range of efficacy; there is no reason to Commenting on the PRA, one diseased and healthy fruit are being believe that some feature of Xac would commenter noted that a low packed. This commenter suggested that defeat the mechanism of SOPP. In concentration of 8 cfu/mL (cited as a we amend the regulations to exclude addition, the RMA cited other studies result of treatment by one study) may fruit from being packed from orchards establishing the efficacy of SOPP as a mean very high numbers of bacteria in or harvested fruit lots with an incidence treatment against Xac itself. tons of fruit. of citrus canker above some established The PRA contained the following The commenter’s assertion is correct. threshold, in order to minimize statement regarding treatment However, shipments of fruit are contamination of packing lines. effectiveness: ‘‘Studies performed in commercially packed in boxes or other We acknowledge that infected fruit in Argentina on the effectiveness of approved containers and are dispersed a lot could contaminate the packing line sodium hypochlorite on mature through market channels all over the with Xac, but, as stated above, symptomless fruit artificially United States, greatly diluting the substantial evidence indicates that the contaminated with Xac showed that concentration of bacteria which are at epiphytic bacterial populations that sodium hypochlorite levels as low as 8 the same time experiencing rapid could be transferred from the packing ppm were effective in eliminating mortality. Therefore, such bacterial line to the fruit do not infect mature epiphytic or surface bacteria from the concentrations would not occur in the fruit or survive on mature fruit long fruit (Canteros, undated).’’ One real world. In any case, for the reasons enough to infect other hosts. For that commenter stated that there were no stated above, we have determined that reason, we have determined that grove references about the viability of the fruit with epiphytic bacterial inspections are not necessary to mitigate bacteria, which is an important factor populations is not an epidemiologically the risk associated with such for risk assessment. significant pathway for the spread of contamination, nor is disinfection of the This particular study was one of many citrus canker. packing line equipment necessary if studies cited in the PRA and RMA Some commenters were also canker is found during the inspection of establishing the effectiveness of sodium concerned about the possible presence a lot of fruit. hypochlorite as a treatment. Other of Xac on other materials, citing reports The RMA stated that ‘‘Bacteria within studies we cited included references of Xac survival for various periods on lesions may be more protected from the about the viability of the bacteria. media like clean microscopic slides; leaf detrimental effects of washing, Related to the presence of bacteria on surfaces, plastic, wood, and other disinfection and drying. Viable Xac has the surface of treated fruit (also referred materials; cloth, sawdust and shavings, been recovered by APHIS pathologists to as epiphytic bacteria or dried herbarium tissue, and sterile soil; from citrus canker lesions on fruit contamination), several commenters and non-host weeds. culled from packinghouse lines after stated that fruit with such populations While Xac undoubtedly persists on a postharvest treatments (Riley 2007).’’ A pose a risk of spreading citrus canker number of surfaces, it does not multiply few commenters expressed concern that was not addressed by the measures outside of hosts. Under the regulations, relating to this statement. One stated recommended in the RMA. the interstate movement of any that chlorine is well known as a surface While surface populations of Xac regulated article other than fruit, sanitizer but has no ability to penetrate undoubtedly exist on some citrus fruit calamondin and kumquat plants, and beyond the surface—for example, into that is packed in a quarantined area, and seed is prohibited. Regulated articles lesions. Another commenter noted that commenters cited scientific evidence include leaves and grass clippings. In none of the experiments mentioned in establishing this point, substantial addition, under paragraph (c) of the PRA or RMA evaluate the effect of evidence indicates that surface bacterial § 301.75–3, an inspector may designate disinfectants on Xac within the fruit, populations do not infect mature fruit or any other product, article, or means of either in visible lesions (of any size) or survive on mature fruit long enough to conveyance, of any character in circumstances where the effects of infect other hosts. The evidence cited in whatsoever as a regulated article when Xac are not visible to the naked eye. The the RMA regarding epiphytic survival it is determined by an inspector that it third, reacting to the statement about indicates that epiphytic populations on presents a risk of spread of citrus canker recovery of viable Xac by APHIS harvested, mature fruit decline rapidly. and the person in possession thereof has pathologists after postharvest For example, researchers in Brazil actual notice that the product, article, or treatments, asked what treatment had sprayed asymptomatic fruit, picked means of conveyance is subject to the been performed, what level of recovery

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had occurred, what preharvest testing to demonstrate efficacy in the quarantined area and packing lots of management the fruits were subject to, field. fruit not produced in a quarantined why the fruits were not culled on the We are making the data on PAA area. Therefore, this final rule also adds packing line before treatment, and testing available on the Regulations.gov PAA, when used indoors, as an whether the postharvest treatment Web site with this final rule (see approved treatment for vehicles, included wax. footnote 1 at the beginning of this final equipment, and other articles in As stated earlier, the surface rule) or from the person listed under paragraph (d) of § 301.75–11. We may disinfectant treatments required in this FOR FURTHER INFORMATION CONTACT. decide to add PAA as a treatment for final rule reduce numbers of Xac cells As noted earlier in this document, the outdoor use in a separate rulemaking if to low or undetectable levels. The RMA use of a proxy or surrogate is not we receive requests to do so. acknowledges that treatment with unusual when testing a treatment’s The proposed rule would have added surface disinfectants is not effective on efficacy on a quarantine pathogen. The PAA as a fruit treatment in a new canker lesions, which is why this final EPA label for PAA, which states the paragraph (a)(4) in § 301.75–11. rule also requires an APHIS inspection approved instructions for use and Paragraphs (a)(1) and (a)(2) authorize of each lot of fruit for canker lesions. applicability of the disinfectant, the use of sodium hypochlorite and The canker lesions referred to in Riley acknowledges that it was tested on Xa SOPP, respectively, as treatments for as a surrogate for Xac. (2007) occurred in fruit produced under fruit; paragraph (a)(3) requires that these X. axonopodis pv. citrumelo and X. the regulations that were in place before two surface disinfectants be applied in axonopodis pv. citri differ primarily in accordance with label directions. the publication of this final rule, i.e., the hosts they infect. (‘‘pv.’’ stands for Instead of adding PAA in a new with certification of grove freedom and ‘‘pathovar,’’ which distinguishes strains paragraph (a)(4), we have redesignated with surface disinfectant treatment. As or subspecies of the same bacteria based paragraph (a)(3) as (a)(4), added PAA in the regulations in place before the on their ability to only infect specific paragraph (a)(3), and amended publication of this final rule did not hosts.) X. axonopodis pv. citrumelo is paragraph (a)(4) to indicate that PAA require specific canker management generally considered to be more must be applied in accordance with measures, we do not have records of resistant to disinfection than X. label directions as well. what canker management measures the axonopodis pv. citri, making the former fruit may have been subject to beyond a suitable surrogate for the latter. The regulations in 7 CFR part 305 set the measures required by the In addition, PAA is an oxidizing agent out the requirements for phytosanitary regulations. whose mode of action has been shown treatments. Section 305.11 contains the two treatments that have been Addition of Peroxyacetic Acid to be effective on many bacteria, authorized for citrus fruit moved from a Treatment including Bacillus cereus, B. subtilis, B. stearothermophilus, Clostridium citrus canker quarantined area. We proposed to add a new surface botulinum, C. butyricum, C. sporogenes, Accordingly, in this final rule, we are disinfectant treatment using Ditylenchus dipsaci, Enterococcus amending that section to add PAA as a peroxyacetic acid (PAA). The proposed faecium, Escherichia coli (including E. treatment for fruit. rule would have required the regulated coli O157:H7), Fusarium oxysporum, Inspection and Potential for Mature fruit to be thoroughly wetted for at least Gluconobacter oxydans, Lactobacillus Fruit Without Visible Lesions To Serve 1 minute with a solution containing 85 plantarum, L. thermophilus, as Pathway for Infection ppm peroxyacetic acid. At the request of Leuconostoc mesenteroides, Listeria growers in Florida, we evaluated the monocytogenes, Pseudomonas As mentioned earlier in this efficacy of this treatment and aeruginosa, P. fluorescens, document, the PRA examined the risks determined that the disinfectant is at Saccharomyces cerevisiae, Salmonella associated with asymptomatic fruit. The least as efficacious as a surface typhimurium, Staphylococcus aureus, PRA used the term ‘‘asymptomatic’’ to disinfectant treatment as the currently Streptococcus delbreuckii subsp. refer to the lack of visible signs or approved disinfectants listed in the bulgaricus, and Yersinia enterocolitica. symptoms of citrus canker. The RMA regulations. In the RMA, we described Based on PAA’s characteristics as a examined the risks associated with all the tests that had been performed to general disinfectant and the results of fruit that has been commercially confirm the efficacy of PAA. These tests the testing on Xa citrumelo, we have packed, regardless of its disease status. were conducted on X. axonopodis pv. determined that PAA will be effective We also prepared a quantitative model citrumelo (Xa citrumelo), which was on Xac as well, and we are adding PAA (Appendix 1 to the RMA) based on used as a surrogate for X. axonopodis as a surface disinfectant treatment for Florida production and shipping data to pv. citri (i.e., Xac). fruit in this final rule. evaluate the efficacy of three levels of Two commenters stated that PAA We are making three other changes phytosanitary inspection in ensuring should be tested on Xac itself rather related to PAA. While paragraph (a) of that symptomatic fruit does not enter than on a surrogate. One stated that Xa § 301.75–11 sets out treatments for fruit, commercial citrus-producing States. In citrumelo does not infect fruit and does paragraph (d) of that section sets out the qualitative model, we defined not survive in orchards, making it a requirements for treatment of vehicles, ‘‘symptomatic’’ as meaning that the fruit poor surrogate, and asked that we make equipment, and other articles. A have visible Xac lesions 1 millimeter the data referred to in the RMA publicly solution of 85 ppm of PAA is also (mm) in diameter and greater. One available. Another stated that, while it effective when used on vehicles, commenter pointed out that these terms seems highly likely that PAA may be equipment, and other articles, and the were used inconsistently in the PRA effective against Xac, to allow its use availability of PAA as a treatment for and the RMA. without any testing against the packing line equipment would be useful We appreciate the comment. In the particular organism of concern appears for packinghouses in the quarantined version of the RMA that accompanies to be unnecessarily optimistic. The area to fulfill the requirements in this final rule, Appendix 1 refers to fruit commenter recommended testing in § 301.75–7(c)(2)(iv) for disinfection of that have visible canker lesions and fruit field conditions for this application or at packing equipment between packing that do not, rather than to symptomatic least to demand post-introduction lots of regulated fruit produced in a and asymptomatic fruit.

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This commenter further stated that (prick) inoculations and natural after the packing process is completed the proposed APHIS inspections of fruit infections and therefore provide little will result in the rejection of any lot of target only relatively large symptoms information about how the ratio of fruit that has visible canker lesions and readily visible to the naked eye, not typical to atypical lesions on fruit varies will prevent that lot from moving in whether any bacteria are present on the under natural conditions. Koizumi’s interstate commerce. fruit. While the APHIS inspection is results varied greatly over the several Wounded fruit. One commenter cited probably fairly effective at limiting the years he conducted these experiments; Fulton and Bowman (1929), who occurrence of larger Xac lesions in the commenters cite results from the inoculated a mature grapefruit from the marketed fruit, the commenter stated, year with the highest incidence of market and 75 days later tested the inspection is totally ineffective at infection, which coincided with grapefruit. The test indicated that there detecting and limiting lesions smaller unusually high temperatures and two were ‘‘something like 32,000 bacteria than 1 mm or at detecting Xac-infected typhoons (hurricanes). Koizumi per puncture,’’ although the fruit had fruit that have no visible lesions at the speculated that the atypical lesions were not developed external lesions. Another time of inspection. This commenter and the result of restricted expansion commenter stated that a general other commenters also addressed brought on by physiological changes in principle of postharvest pathology is surface populations of bacteria, stating the maturing fruit and lower ambient that surface disinfestation of fruit with that focusing inspection efforts on temperatures. As noted by Graham et al. standard oxidizing chlorine washes will visible lesions ignores risk associated (1992b), the small late season lesions inactivate most microorganisms from with bacteria. were characterized by a ‘‘lack of the surface of non-wounded fruit, but We addressed the risk associated with bacterial proliferation.’’ Lesions without not from fruit wounds. epiphytic bacterial populations earlier proliferation would not provide an The grapefruit described in Fulton in this document. We have determined epidemiologically significant source of and Bowman (1929) was one of a that the other situations described by inoculum for Xac infections. number of market fruit that were these commenters are unlikely to occur While other studies have conducted inoculated in this way, the rest of which outside of an experimental setting. The similar inoculation tests on fruit before either rotted after inoculation or reasoning behind this determination is (Fulton and Bowman 1929) and after supported bacterial populations that did discussed below. (Graham et al. 1992b; Verniere et al. not multiply. All these fruits were kept Small lesions (less than 1 mm). 2003), Koizumi (1972) remains the only in moist laboratory conditions designed Commenters cited Koizumi (1972), in paper to describe this type of lesion. to facilitate the development of Xac which Satsuma mandarin were either Fulton and Bowman noted that if one bacteria. prick inoculated with Xac or naturally was not careful to avoid oil glands when Regarding the grapefruit, Fulton and infected. The experimenter found that, making puncture inoculations, the Bowman stated the following in their in addition to lesions greater than 1 mm, released oils cause injuries to the 1929 study: ‘‘There is apparently a very lesions referred to as ‘‘late detection adjacent tissue. One could speculate marked difference in the behavior of the (small)’’ of a size of 0.1 to 0.15 mm also that at least some of Koizumi’s atypical canker organism following inoculations occurred. This would be below what we lesions might, in fact, be injuries. We in the peel of mature fruit after removal have determined to be the size threshold have no evidence that the lesions from the tree as compared with its for a detectable lesion, as defined in described by Koizumi (1972) occur in behavior in the peel of mature fruit still Appendix 1 to the RMA. Besides stating nature and therefore cannot agree that on the tree. Possibly changes in the that the existence of such lesions they would occur at the rates cited by physiological condition of the fruit indicates that fresh fruit could be a the commenters. resulting from its removal from the tree pathway for the introduction or spread Nevertheless, conditions could exist are responsible for the difference * * * of citrus canker, the commenter also in which small Xac lesions occur. senescent changes in the peel favor the stated that it is possible that disinfecting However, as noted above, immature development of fungi having the surface of the fruit might exacerbate fruit are most susceptible to Xac saprophytic tendencies; it is not the subsequent infectivity of Xac infection, and Xac lesions grow as the inconsistent to presume these changes exuding from small lesions, by fruit matures; the growth of the lesions would in equal degree hinder the removing other (e.g., rot-provoking) slows as the fruit reaches maturity. development of an organism having organisms that might directly or Picking mature fruit from the tree causes definitely parasitic habits like indirectly accelerate the decline of Xac senescence of the fruit and further Pseudomonas citri [Xac].’’ This is after harvesting. inhibits lesion development. Therefore, consistent with a determination that As discussed in the RMA, in the field, while small lesions might occur on infected wounds would occur extremely immature citrus is most susceptible to immature fruit, they would typically rarely in real-world conditions. infection with Xac and lesion grow into larger lesions as the fruit Fulton and Bowman also reported development. Mature citrus fruit have matures; if there were small lesions that infection only occurred if the natural wax layers on their surface, present on such fruit, it would be likely wound stayed moist until the time of decreasing susceptibility by reducing that lesions larger than 1 mm would be inoculation. Wounds that were allowed access to natural openings, such as present as well. In general, APHIS to dry and were inoculated after 26 stomata. In addition, mature (not inspectors do not see fruit with only hours did not result in infection. That expanding) asymptomatic fruit without lesions smaller than 1 mm; small lesions is, infections occurred only when oil injuries or blemishes are not known to occur in association with larger lesions glands were avoided and inoculum was develop symptoms in the field. In the (Riley 2007). applied within 26 hours of wounding Koizumi (1972) study, mature fruit were The packinghouse culling and grading (Fulton and Bowman 1929). Verniere et experimentally inoculated while the procedures are designed to remove fruit al. (2003) reported a disease incidence fruit was still attached to the tree; with visible lesions and would result in of zero when inoculating mature fruit equivalent conditions are extremely removal of the fruits likely to harbor the either by pin prick or spray inoculation. unlikely to occur naturally. highest pathogen loads, and therefore As noted above, the conditions that The lesions Koizumi observed present the greatest risk of disease would allow citrus canker to develop in resulted from a combination of artificial transmission. The APHIS inspection wounds in the field are unlikely to

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occur. In addition, any fruit with receive training provided by the State in inspection is performed on fruit that has wounds would likely be culled in the identifying canker lesions. The been removed from the packing line. field or by the packinghouse before it phytosanitary inspection that will be Under packinghouse conditions, there could be submitted for APHIS performed by APHIS in this final rule is no time limit for fruit inspection once inspection. will provide another layer of inspection the fruit is randomly sampled. This can Based on this evidence, we have protection. We provided evidence be accomplished because the fruit is determined that fruit with small lesions supporting these points in the RMA, inspected individually, away from the or infected wounds would occur including detailed evidence about the packing line. The 40-second time limit extremely rarely and are not likely to be efficacy of APHIS’ inspection process. during training is a performance epidemiologically significant when they Scientific evidence indicates that these requirement for training, not a do appear. Therefore, it is appropriate to measures are highly effective, but since packinghouse inspection requirement. focus our inspection efforts on detecting uncertainty remains about the The estimate that the packinghouse lesions 1 mm or greater. epidemiological significance of inspection would require 5 seconds per The RMA stated that APHIS plant symptomatic fruit, we are prohibiting fruit is also not an APHIS packinghouse pathologists have intercepted fruit in the distribution of fruit moved interstate inspection requirement; rather, this final packed cartons with lesions in the to commercial citrus-producing States. figure was cited in the context of the 2–3 mm range and have observed that As discussed earlier in this document, potential economic impact of the lot the majority of the symptomatic fruit the APHIS packinghouse-based inspection on the packinghouse, and that APHIS inspectors intercepted after inspection is sufficient to detect, with a specifically in discussing possible passing through the packing line 95 percent level of confidence, any lot delays associated with inspection. undetected by graders have only one of fruit containing 0.38 percent or more Inspectors who see questionable lesions lesion (Riley 2007). Two commenters fruit with visible canker lesions. In will be able to take whatever time is addressed this statement. Both asked for other words, if the infection pressure is necessary to determine whether those data on interceptions in Florida fruit, higher than 0.38 percent of the fruit, it lesions are canker lesions. with one asking for information on how is extremely likely that the lot will be The ELISA Dip Stick test did many fruit were detected and what rejected from interstate commerce. correspond to already detected lesions. varieties were found to be infected. APHIS inspection is thus effective The results of the ELISA Dip Stick test These data are available from the regardless of infection pressure. were cited in the RMA to provide person listed under FOR FURTHER One commenter, responding to both empirical data on the size of lesions that INFORMATION CONTACT. the evidence presented for APHIS can be detected by inspectors. The One commenter stated that the fact inspectors’ detection efficacy in the ELISA Dip Stick test is not part of the that APHIS inspectors intercepted fruit qualitative portion of the RMA and in detection system that will be used in with lesions did not substantiate the the model in Appendix 1, stated that commercial packinghouses under this statement made later in the RMA that none of the evidence provided for final rule; it will be used only for grading and inspection procedures are APHIS inspectors’ detection efficacy confirmation of lesions found by effective in removing fruit with visible corresponds to field conditions for inspectors. lesions. Another commenter stated that detection of lesions. The commenter One commenter disagreed with the all canker infections cannot be detected noted that the cited figures for refresher idea that only ‘‘finished’’ fruit would be in packinghouses without knowing training correspond to identification inspected for citrus canker in the whether the fruit originates from a within 40 seconds of a lesion presented packinghouse. The commenter stated canker-free grove, or at least a grove to the inspector, which the commenter that citrus canker is more easily with a very low level of canker stated was inconsistent with location of detected on fruit that has not been infection. The commenter stated that it a rare lesion on a fruit in a continuous through the packing process. Brushing is very difficult, if not impossible, to search of 1,000 fruit samples within an of fruit on the packing line may remove distinguish canker blemishes from average of 5 seconds, an estimate we diseased tissue, the commenter stated, numerous other blemishes, especially in presented in the Regulatory Impact and waxing of the fruit will make the the growing conditions that prevail in Analysis for the proposed rule in the disease harder to diagnose. Florida, where many blemishes appear context of describing the proposal’s Inspection of fruit before they go on fruit. potential impact on packinghouse through the packing process would not One commenter cited the example of operations. The commenter stated that allow the packinghouses themselves to citrus affected by septoria, a fungus, that evaluation of enzyme-linked cull canker-infected fruit prior to are exported to Korea. This commenter immunosorbent assay (ELISA) Dip Stick packing. In the RMA, we described in stated that the California citrus industry tools and the evaluation of a diagnostic detail the efficacy of inspection of conducts vigorous training programs for tool (if that is a separate exercise from finished fruit for citrus canker, as line employees to identify and eliminate the ELISA Dip Stick tool) also discussed earlier. fruit with distinguishable symptoms corresponded to classification of Our experience indicates that washing and that this culling is then augmented already-detected lesions. fruit will make it easier to detect citrus by laboratory analysis. The commenter We appreciate the opportunity to canker lesions. Citrus fruit that comes stated that lab analysis has always clarify the evidence presented in the directly from the field is often covered detected symptoms on a small RMA on the APHIS phytosanitary in dirt, sooty mold, and other debris and percentage of fruit missed by highly inspection. The evidence provided in material that could obscure citrus trained employees. the RMA is consistent with the canker lesions. Washing the fruit We appreciate the opportunity to proposed rule’s approach of using removes some of this material. Because clarify this point. Various evidence, as inspection to detect lesions in the citrus canker lesions occur within the cited in the RMA, indicates that packinghouse. The training for peel of the fruit, they would not be packinghouse grading and inspection phytosanitary inspectors was done in brushed off during finishing. procedures are effective in removing packinghouse conditions, using culled Additionally, the wax used on fruit is fruit with visible lesions. Packinghouse fruit for the test sample. Both in training transparent, which means it would not graders and inspectors in Florida also and testing and in the packinghouse, impede disease detection.

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Potential Pathways for Spread of Citrus distance movement due to storm or environmental conditions for infection Canker Through Movement of Fruit cyclone activity. to occur. The available evidence indicates that While it is true that one bacterium is As mentioned earlier, the RMA that the maximum range for spread of citrus sufficient to cause infection, that one was made available with the proposed canker through storm activity would not bacterium would have to encounter rule concluded that the introduction be sufficient to spread citrus canker conditions that were appropriate for and spread of Xac into other from Florida to another commercial infection. There is a very low likelihood commercial citrus-producing States citrus-producing State. that any one bacterium will encounter through the movement of commercially One commenter suggested that citrus conditions sufficient to cause infection; packed fresh citrus fruit is unlikely canker could be spread through it is difficult to create these conditions because: movement on workers’ clothes and even in a laboratory setting. Under • Fresh citrus fruit is produced and picking bags. natural conditions, it would require harvested using techniques that reduce As discussed earlier, while Xac can thousands if not millions of tries for one the prevalence of Xac-infected fruit; persist on a number of surfaces, its • bacterium to cause infection. Gottwald Citrus fruit is commercially packed infectivity outside lesions is unknown. and Graham (1992) estimated that as using techniques that reduce the We do not agree that it is likely that few as 2.4 Xac bacteria forced into a prevalence of infected or contaminated workers will move between Florida and water congested stomatal cavity of a fruit, including disinfectant treatment other commercial citrus-producing susceptible plant were sufficient to for epiphytic contamination; States without laundering their clothes • cause a lesion. However, they also For a successful Xac infection that and while carrying their own picking determined that the minimum results in disease outbreaks to occur an bags. The commenter provides no concentration of bacteria in the unlikely sequence of events would have evidence that could be used to inoculum needed to produce an to occur; empirically estimate the frequency of • infection, and presumably to place the Reports of citrus canker disease such behavior, and APHIS is unaware of estimated 2.4 bacteria in a stomatal outbreaks linked to fresh fruit are any such evidence. cavity, was 105 cfu/mL. Thus, although absent; and Two commenters suggested that citrus • it may take only 2.4 infective bacteria in Large quantities of fresh citrus fruit canker could be spread if fruit or peel the right place to cause infection, it shipped from regions with Xac have not from citrus fruit infected with Xac is takes exponentially greater numbers of resulted in any known outbreaks of placed in or around susceptible host bacteria in the inoculum for those 2.4 citrus canker disease. plants, after which a water event moves bacteria to occur in the right place at the One commenter stated that we did not the bacterium from the fruit or peel to right time. enumerate any complete pathways for the host plant. One commenter cited The data submitted by one commenter transmission and so did not evaluate the Koizumi (1972) as evidence that Xac (see http://www.regulations.gov/ scientific evidence in such a way as to could be recovered from fruit peel for fdmspublic/component/ evaluate the possibility or likelihood for months if the peel was placed in main?main=DocumentDetail&d=APHIS- transmission along such pathways. The physiological solution for 2 hours. This 2007-0022-0053), in which infected fruit commenter also stated that there are commenter stated that only one were placed next to grapefruit seedlings pathways (including illegal diversion of bacterium is required to cause infection. in natural conditions for 2 months fruit and perfectly legal amateur grower Another commenter cited fruit with live without infection of the seedlings, activities) from every part of the country Xac cells that are thrown into a compost suggests that the likelihood of such an that may lead to infection of commercial pile or bin under a backyard citrus tree, occurrence may be low. citrus areas and that have not been after which a splash or water movement Finally, for this pathway to occur, evaluated. This commenter and another occurs. Once a backyard citrus plant rain or storm conditions would have to commenter suggested several potential was infected, these commenters stated, prevail that could spread the bacterium pathways that we had not addressed in rain or storm events could spread the over long distances, but Borchert et al. the RMA. bacterium to commercial citrus groves. (2007) concluded that such conditions In general, it is difficult to examine The Koizumi (1972) study recovered are unlikely to prevail outside Florida, quantitatively the pathways by which bacteria using physiological solution, a the State that is currently quarantined infected fruit could theoretically spread buffered saline solution that ensures for citrus canker. citrus canker. Those pathways are optimal conditions for bacterial We acknowledge that it is possible dependent on consumer behaviors and recovery. Analogous conditions do not that all of these circumstances could biological events for which we lack data occur in nature. Additionally, for this prevail, but such a ‘‘perfect risk’’ that we could use to quantify them, and scenario to occur, citrus fruit that is scenario would be an extremely rare no such data were provided by the infected would have to have been event. The commenter provides no commenters. This lack of data is one moved from a quarantined area into a evidence that could be used to reason we have determined that it is commercial citrus-producing State— empirically estimate the frequency of appropriate to prohibit distribution of movement that is prohibited by the this behavior, and APHIS is unaware of fruit moved interstate from a regulations. As discussed earlier, we are any such evidence. quarantined area to commercial citrus- increasing monitoring and disease One commenter suggested a fruit-to- producing States. As discussed earlier, surveillance activities and making human-to-plant pathway for the such a prohibition, combined with the changes to the regulations in order to introduction of citrus canker into a monitoring and enforcement efforts help prevent the illegal or inadvertent commercial citrus-producing State. A APHIS will use to ensure that the movement of fruit from quarantined hobbyist who cultivates citrus in a State prohibition is adhered to, is effective at areas into commercial citrus-producing other than a commercial citrus- preventing the illegal movement of fruit. States. If an infected fruit was illegally producing State could handle infective We discuss the specific pathways moved into a commercial citrus- citrus from the quarantined area, then brought up by the commenters below. producing State, it would have to be infect the plants the hobbyist is One commenter suggested that citrus exposed to susceptible plants under cultivating. The hobbyist might not canker could be spread through long- very specific physical and notice the canker infection and could

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subsequently move the infected plants This measure makes modeling of California and Texas. The RMA cited into a commercial citrus-producing pathogen establishment, infection, and Peltier and Frederich (1926) as State. disease severity in commercial citrus- indicating that the disease ‘‘could We acknowledge that such an producing States unnecessary. develop in all of the citrus regions of the occurrence is possible, but such a The Borchert et al. (2007) study is an world sometime over the growing ‘‘perfect risk’’ scenario would be an internal APHIS document. We made the season.’’ These facts do not change our extremely rare event. The commenter study available to commenters who conclusions that (1) only a small portion provides no evidence that could be used requested it during the comment period, of each commercial citrus-producing to empirically estimate the frequency of and it is available from the person listed State actually produces citrus, and an such amateur citrus grower behavior, under FOR FURTHER INFORMATION even smaller portion has a climate and APHIS is unaware of any such CONTACT. The Borchert et al. (2007) suitable for canker disease development; evidence. study provides the modeling requested and (2) the climate in Florida is the most None of the pathway scenarios by the commenters. favorable of any State for the suggested by the commenters have Some commenters addressed the risk development of citrus canker, and it changed the RMA’s conclusion that an citrus canker posed to specific States. would be more difficult for citrus canker unlikely sequence of epidemiological One commenter stated that California is to be introduced into and subsequently events would have to occur for a a fresh citrus State with more than become established in any other State. successful Xac infection that results in 200,000 acres dedicated to the fresh Regardless, the remaining uncertainty disease outbreaks to occur as a result of market production of oranges, , about the level of risk associated with the movement of commercially packed, grapefruit, mandarins, and other citrus the movement of citrus fruit from a treated, and APHIS-inspected fruit to varieties. Although the majority of the quarantined area has led us to maintain States other than commercial citrus- oranges are grown in arid areas, many the current prohibition on the producing States. of the lemons and some of the grapefruit movement of citrus fruit into are produced in climates with higher Potential for Citrus Canker commercial citrus-producing States. humidity and rainfall. The commenter Establishment in Commercial Citrus- Two commenters urged APHIS to stated that the survival of canker in Producing Areas address the risk of spreading citrus these areas would be expected; the canker to other potential host areas, The RMA included a discussion of the survival of canker in the more arid areas which may not be areas where citrus is susceptibility of commercial citrus- is less certain, but canker’s potential commercially produced. One producing areas that are not currently impact cannot be ignored based on commenter stated that citrus (not just quarantined for citrus canker to the survival reports from other arid lands. fruit-bearing trees) can be and is grown spread of the disease. This discussion Another commenter, addressing the in other areas of the United States, and included a reference to a study by suitability of California’s climate for those areas are also at risk of citrus Borchert et al. (2007) that developed a development of citrus canker, stated canker. The commenter noted that citrus canker spread model using the that Dalla Pria et al. (2006) stated that during the initial outbreak of citrus North Carolina State University APHIS the greatest severity of canker occurred canker in the mainland United States, Plant Pest Forecast System to identify at 24 hours of leaf wetness, with 4 hours disease outbreaks were also recorded in areas where citrus canker could become of wetness being the minimum duration Alabama, Mississippi, South Carolina, established in the major citrus- sufficient to cause 100 percent and Georgia. The commenter also noted producing regions of the United States. incidence at optimal temperatures of that Borchert et al. (2007) were tasked Two commenters stated that modeling 25 °C to 35 °C. ‘‘to identify areas where citrus canker of pathogen establishment, infection, Another commenter stated that when could become established in the major and disease severity should be an Texas had citrus canker, it was in citrus producing regions of the United essential component of the risk southeast Texas, which has higher States,’’ rather than all the areas in the assessment for each citrus-producing rainfall than the Rio Grande Valley. The United States in which citrus canker State and region within the State, Rio Grande Valley generally has high could become established. adding that the Borchert project results relative humidity, although the These commenters recommended that should be made publicly available. commenter stated that there is the RMA and the proposed rule take We disagree that modeling of tremendous variability in Texas’ account not only of current commercial pathogen establishment, infection, and weather patterns; for example, July 2007 citrus-producing areas, but also areas disease severity in commercial citrus- has been very wet. The commenter where citrus currently grows (even if it producing States is a necessary stated that canker would be able to is not commercially grown) and areas component of the risk assessment. The thrive in the conditions present in the where citrus could grow, but does not RMA concluded that the introduction commercial growing area of South currently. These commenters stated that and spread of Xac into other Texas. Surveys for citrus greening, the establishment of citrus canker in any commercial citrus-producing States commenter stated, have revealed that such area might subsequently lead to through the movement of commercially Texas has substantial amounts of citrus establishment in commercial areas, packed fresh citrus fruit from in an area approximately 100 miles since many of these areas are contiguous quarantined areas is unlikely. north of the Gulf of Mexico from with commercial areas, and long- Nevertheless, because the RMA Brownsville to Houston. The commenter distance transport now appears to be concluded that the evidence is not noted that the challenges of eradicating more likely than historically, currently sufficient to support a canker in the urban areas of Florida presumably due to the presence of the determination that fresh citrus fruit contributed to the failure of the Asian leafminer (Phyllocnistis citrella produced in a Xac-infested grove cannot eradication program and anticipated Stainton) in Florida. These commenters serve as a pathway for the introduction that many of those same difficulties also stated that citrus canker of Xac into new areas, we are would be experienced in Texas if citrus establishment in areas where citrus is prohibiting the interstate movement of canker appeared in urban areas. not commercially produced would lead fruit from a quarantined area into We agree with these commenters that to other pathways for establishment in commercial citrus-producing States. citrus canker could be introduced to areas where it is.

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The focus of the citrus canker has agreed not to impose conditions on the assessment will take into account all program has been on commercial citrus- the importation of commodities that are relevant local conditions and all pests producing States because these States more restrictive than those we impose that are present in Japanese citrus present the highest likelihood for on the domestic movement of similar production areas. introduction of the disease, due to the commodities. These commenters stated It is important to note that Unshu density of citrus plantings in those that the RMA should consider the risk oranges from Japan, if they are States. Prohibiting the movement of associated not only with the interstate fumigated for arthropod pests, are fruit from areas quarantined for citrus movement of citrus fruit from domestic allowed to be imported into commercial canker to States other than commercial quarantined areas but also the risk citrus-producing States, because they citrus-producing States would be overly associated with potential imports from are produced under a systems approach. restrictive. foreign citrus-producing areas affected Fruit moved interstate from citrus We acknowledge that dooryard with citrus canker. canker quarantined areas is not allowed plantings of citrus exist outside of One commenter who had expressed to be moved into those States under this commercial citrus-producing States. concern about illegal movement of final rule. However, while canker infection in a Florida citrus into commercial citrus- One commenter noted that the term State other than a commercial citrus- producing States stated that this ‘‘commercially packed’’ can be producing State could serve as a potential problem would only increase interpreted in different ways. In South pathway for introduction into a if citrus fruit was allowed to be Korea, the commenter stated, one group commercial citrus-producing State, as imported from foreign areas affected of growers used a ‘‘commercial’’ packing discussed earlier under the heading with citrus canker. shed that was no more than 75 meters ‘‘Potential Pathways for Spread of Citrus Our analysis of the risk associated by 50 meters and in which the post- Canker Through Movement of Fruit,’’ an with the importation of citrus fruit from harvest treatment with sodium unlikely sequence of epidemiological other countries where citrus canker hypochlorite was performed in a small events would have to occur in order for exists under conditions similar to those bath. The commenter stated that it is citrus canker to be introduced and in this final rule would be conducted important to recognize that different established through the movement of separately from the analysis we circumstances prevail in different citrus fruit from a quarantined area. conducted for this rulemaking. Before countries when harmonizing domestic If, in the future, commercial we would consider using an approach regulations with import regulations. quantities of citrus are planted in a State similar to that promulgated in this final We fully agree with the commenter that is not currently designated as a rule to allow the importation of citrus that the circumstances in a country commercial citrus-producing State, we fruit from canker-affected areas in would need to be assessed before we will designate that State as a another country, the national plant could allow the importation of citrus commercial citrus-producing State in protection organization of such a from a citrus canker-affected area under § 301.75–5. country would need to submit a request conditions similar to those under which As discussed in the RMA, injuries that we do so. A country requesting to we are allowing the movement of citrus caused by the Asian leafminer can be able to use this framework to export from a citrus canker quarantined area. produce wounds that serve as infection citrus to us would have to demonstrate With regard to the specific courts in leaves and, to a lesser extent, the ability to perform the required circumstance cited by the commenter, fruit, but the leafminer itself is not a treatments and phytosanitary we have determined that it is necessary vector for the spread of citrus canker. inspections; it would also be required to to define the term ‘‘commercial have a bilateral workplan in place with packinghouse’’ in this final rule, given Potential Application of the APHIS. Depending on the that the PRA and RMA analyzed the risk Packinghouse-Based APHIS Inspection circumstances, we may allow imports associated with the interstate movement System to Imported Citrus only through a preclearance program of commercially packed fruit. In this The regulations in 7 CFR 319.28 staffed by APHIS inspectors whose final rule, we are adding a definition of prohibit the importation of citrus fruit salaries are funded by the exporting commercial packinghouse to the from areas where citrus canker is country. In addition, there may be other regulations. This definition reads: ‘‘An present, except for Unshu oranges from citrus pests in foreign citrus production establishment in which space and Japan and Cheju Island, Republic of areas whose risk would need to be equipment are maintained for the Korea, that are produced in accordance mitigated separately from the risk posed primary purpose of packing citrus fruit with the systems approach described in by citrus canker. For these reasons, we for commercial sale. A commercial paragraph (b) of that section. The have not amended the RMA that packinghouse must be registered as a systems approach for Unshu oranges accompanies this final rule to discuss packinghouse with the State in which it from Japan and Korea requires measures potential imports from other countries. operates or hold a business license for to ensure that the oranges are produced One commenter specifically noted treating and packing fruit.’’ This in an area free from citrus canker; for that the requirements for Unshu oranges definition will help to ensure that the Unshu oranges from Japan, the systems from Japan are not in harmony with the packinghouses that pack fruit for approach requirements also address the proposed rule. interstate movement under this final citrus fruit fly. The proposed rule and the risk rule have equipment and operating Several commenters expressed management analysis are based on the procedures that are consistent with concern that the proposed regulations, if most recent science and our those described in the PRA and RMA. implemented, could lead to requests determination of the appropriate level of Because the PRA and RMA referred from other citrus-producing countries to protection for the citrus canker specifically to the risks associated with export citrus fruit under conditions pathogen. We may reassess the risk commercially packed fruit, we are similar to those we proposed for the associated with the importation of amending the proposed regulations in interstate movement of fruit from citrus Unshu oranges from Japan in the future § 301.75–7 to refer specifically to canker quarantined areas. The if Japan requests that we do so. If we commercial packinghouses. commenters noted that, under reassess the risk associated with Unshu One commenter stated that international trade agreements, APHIS oranges from Japan, as discussed earlier, implementation of the proposed rule

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may also result in foreign countries steps, carried out by many people at for Xac development, and leafminer- requesting APHIS to consider a similar different times, are not always perfectly damaged leaves have more and larger approach for fresh commodities other implemented. lesions. One commenter asked whether than citrus. The commenter stated that The RMA concluded that the injuries from the peel miner, an insect the approach described in the proposed introduction and spread of Xac into present in California, could result in rule could be applied in any number of other commercial citrus-producing higher infection of fruits. other situations in which a systems States through the movement of Injuries from the peel miner would be approach is not operationally or commercially packed fresh citrus fruit likely to increase the susceptibility of financially feasible. from quarantined areas is unlikely. fruit to infection, and increase the It is important to note in response to While fruit with visible canker lesions severity of the infection if they became this comment that we determine what has likely been imported into the EU, infected. In terms of overall spread of phytosanitary mitigations are the importation of citrus fruit from areas citrus canker, the peel miner would not appropriate for the importation or where citrus canker is present has not likely be as epidemiologically interstate movement of commodities resulted in the introduction of the significant as the Asian leafminer, since based on our assessment of the risk their disease in the EU, despite the fact that leaves of citrus trees and plants are importation or interstate movement all fruit imported into the EU is allowed more susceptible to citrus canker poses and the appropriate level of to move to citrus-producing areas infection than the peels of citrus fruit. phytosanitary protection against that within the EU. (This is discussed in One section of the RMA discussed the risk. If we determined that a set of more detail in the RMA in Section 5.6.2, effect of shipping and storage mitigations was necessary to provide the ‘‘International and Interstate Movement temperatures on Xac populations, appropriate level of protection for a of Citrus Fruit.’’) In addition, treatment concluding that typical shipping and commodity proposed for importation, and inspection will both serve as storage temperatures reduce such but that set of mitigations was effective mitigations against the populations. One commenter noted that determined not to be operationally or potential of fruit moved interstate to pathologists are able to keep Xac- financially feasible by the national plant introduce citrus canker to other States. infected samples in refrigerators at 2 °C protection organization of the exporting Nevertheless, the RMA concluded that to 4 °C and still isolate the bacterium. country, we would not allow the the evidence is not currently sufficient The commenter stated that the emphasis importation of that commodity. to support a determination that fresh of this section should be on the survival We would only allow the importation citrus fruit produced in a Xac-infested of the bacterium. of a commodity under an approach grove cannot serve as a pathway for the We agree with the commenter that similar to the approach used in this introduction of Xac into new areas. That cool temperatures do not necessarily final rule if we determined that this is why this final rule prohibits the cause mortality for Xac, and the RMA approach could provide the appropriate distribution of fruit moved interstate noted accordingly that such level of phytosanitary protection. In past from quarantined areas to commercial temperatures influence survival rather cases where we have determined that citrus-producing States. than stating that they inactivate the inspection, treatment, and limited In the RMA, we stated that there is no bacteria. However, in the context of an distribution mitigations similar to those authenticated record of the movement of analysis of the likelihood of citrus fruit implemented in this final rule can fresh fruit infected with Xac being serving as a pathway for the provide an appropriate level of related to the epidemiology of citrus introduction or spread of citrus canker, protection against the introduction of canker disease. One commenter stated it is important to note that shipping and plant pests by imported commodities, that pest-free areas are now established storage temperatures reduce Xac we have employed such mitigations. For on the basis of a pest being ‘‘known (as populations. In addition, commercial example, litchi imported from Thailand demonstrated by scientific evidence) not refrigeration is also quite dry, and Xac are inspected for a fungal pathogen, to occur’’ rather than ‘‘not known to is highly influenced by humidity, so the irradiated for arthropod pests, and occur,’’ and the same standard of dryness of refrigeration is more likely to prohibited from being imported or evidence should apply to this statement; have mortality effects than the cold. moved into Florida due to the litchi rust research should be conducted to The RMA stated that fruit are mite. establish this statement as fact. susceptible to citrus canker infection In order for us to determine that a We agree with the commenter’s from petal fall until they are around 6 packinghouse-centered approach characterization of the process by which cm in diameter, and are most provided an appropriate level of pest-free areas are established. Our susceptible at a fruit diameter of about phytosanitary protection, we would statement was not meant to imply that 2–4 cm. One commenter stated that fruit have to determine that the biology of the we had positively established that fresh size cannot be related to susceptibility pest supported such an approach and fruit infected with Xac has never served unless the variety is indicated, as some that the pest in question could be as a pathway for the transmission of varieties (such as grapefruit) are bigger effectively detected by inspection of the citrus canker. Rather, it reflects the fact than others (such as mandarins). commodity. In addition, other that no outbreaks of citrus canker have We agree with the commenter, and we considerations may apply based on the ever been attributed to the movement of have amended the discussion in the level of risk we determine importation infected fruit, despite the brisk global RMA to state that fruit are susceptible of the commodity to pose. trade in such fruit. (The majority of to natural (stomatal) infection from petal outbreaks of citrus canker whose cause fall until they are fully expanded Miscellaneous Comments on the RMA is known were caused by the movement (around 6 cm in diameter for some One commenter noted that, since of infected citrus nursery stock, rather varieties), and are most susceptible after viable Xac have been found in fruits than fruit.) stomata form and fruit is in a stage of with canker lesions that are imported The RMA noted the Asian leafminer rapid expansion, a period of about 90 to into Europe, it is clear that the interacts with Xac by providing wounds 120 days (at a fruit diameter of about 2– importation of symptomless fruits from that serve as infection courts in leaves 6 cm for some varieties). canker-infected areas has a risk of and, to a lesser extent, fruit. Leafminer In discussing the international and introducing the disease if all the control wounds create suitable microclimates interstate movement of citrus fruit, the

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RMA noted that in 2004, India (where unlimited distribution is permitted. The The comment estimating the potential Xac is reported) shipped 8 metric tons model determined, with 95 percent increase in fruit moved interstate under of citrus to Ghana and 2 metric tons to confidence, that the number of Xac- this final rule is dealt with in more South Africa, and that no outbreaks of symptomatic fruit reaching those 5 detail under the heading ‘‘Comments on Xac have been reported in any of the States in a single shipping season would the Preliminary Regulatory Impact recipient countries. One commenter be 633,152 or less at the 1,000 randomly Analysis and Initial Regulatory stated that the shipment of citrus from sampled fruit inspection level. We Flexibility Analysis’’ later in this India to South Africa seems a dubious anticipate that about double that document. We have concluded that the record. number (approximately 1,266,304 or increase in the number of fruit that will These data were drawn from the Food less) of Xac-symptomatic fruit would be moved interstate under this final rule and Agriculture Organization’s ‘‘World reach those States at the 500 fruit is likely much less than the commenter trade and crop production statistics’’ inspectional level. About half that estimates, although we have been database at http://faostat.fao.org. The number (approximately 316,576 or less) unable to quantify the probable commenter provided no further would reach those States at the 2,000 increase. information establishing these records fruit inspectional level. The model This final rule does not change our as dubious. further determined with 95 percent requirements for the importation of We also discussed the movement of confidence that the number of citrus fruit from areas in other countries fresh citrus from Florida during Xac symptomatic fruit reaching citrus- where citrus canker is present. outbreaks. One commenter asked producing areas within those States in Therefore, this final rule will not whether the earlier shipments of Florida a single shipping season would be 2,135 increase the amount of fruit imported fruit were from canker-free areas, or at or less at the 1,000 fruit inspectional from such areas. As stated earlier in this least canker-free areas of production level, about double that number document under the heading ‘‘Potential under official control. (approximately 4,270 or less) at the 500 Application of the Packinghouse-Based We noted in the RMA that these fruit inspectional level, and about half APHIS Inspection System to Imported shipments of Florida citrus may have that number (approximately 1,067 or Citrus,’’ our analysis of the risk originated in areas of low prevalence or less) at the 2,000 fruit inspectional level. associated with the importation of citrus free of Xac. These shipments were (As discussed in Section 9.3.3.4 of fruit from other countries where citrus required to originate in groves that had Appendix 1 to the RMA, the actual canker exists under conditions similar been certified to be free of Xac based on acreage on which citrus is produced to those in this final rule would be an inspection. within a citrus-producing State is a conducted separately from the analysis Comments on the Model in Appendix 1 small fraction of the total acreage of that we conducted for the proposal and this to the RMA State.) The base level inspection of final rule. 1,000 randomly sampled fruit per lot In Section 9.3.3.1 of Appendix 1, we As mentioned earlier, to assist in was adopted because it is operationally determined probability distributions for evaluating the options we identified for feasible with small adjustments to the the number of 4⁄5-bushel cartons packinghouse-centered risk current phytosanitary inspection shipped per growing season for each management, we prepared a quantitative process in Florida. commercial citrus-producing State model (Appendix 1 to the RMA) based The potential for fruit with visible destination and variety of fruit. To on Florida production and shipping canker lesions to reach commercial determine the probability distributions, data to evaluate the efficacy of three citrus-producing States, coupled with we used the minimum, average, and levels of phytosanitary inspection in the aforementioned uncertainty maximum values of the last 4 years ensuring that fruit with visible canker regarding fruit as a pathway, led to the (2003 through 2006) of historical data lesions does not enter commercial determination that additional on citrus fruit shipping from Florida to citrus-producing States. The three mitigations were required. other commercial citrus-producing inspection levels were determined by We received several comments from States. preliminary estimates of the Plant one commenter addressing the model in One commenter stated that the last 4 Protection and Quarantine program’s Appendix 1 to the RMA. seasons of data have been strongly Citrus Health Response Program staff of The commenter stated that the model affected by both natural events (damage inspection levels that might be failed to take into account the increased caused by hurricanes, tree destruction operationally feasible. The three numbers of fruit that would be moved in an attempt to eradicate the canker inspection levels evaluated were 500 interstate from Florida and imported outbreak) and imposed movement fruit per lot, 1,000 fruit per lot, and from citrus canker-affected areas in restrictions (due to the canker outbreak). 2,000 fruit per lot. Statistically, other countries, and thus The commenter noted that over the 10 randomized inspection of 500, 1,000 underestimated the number of years preceding the 2003 through 2006 fruit, or 2,000 fruit per lot will ensure, potentially infected fruit that could data, the average domestic shipping with 95 percent confidence, that the reach commercial citrus-producing quantity was 1.6 times higher than it proportion of undetected fruit with States. The commenter cited another was during those years. The commenter visible canker lesions in a cleared lot is comment that estimated that the spread stated that the uncertainty in the no more than 0.75, 0.38, and 0.19 of canker has resulted in an additional expected average number of fruit that percent, respectively. 20 percent of Florida’s total fresh citrus will be shipped from Florida is therefore The outputs of the quantitative model groves becoming ineligible for interstate considerably higher than would be were probability distributions. The movement under the regulations that expected from examination of just the model determined, with 95 percent were in place before the publication of last four seasons, unless APHIS confidence, that the total number of this final rule. That 20 percent, that considers that the decline in numbers is citrus fruit shipped from Florida to 5 commenter stated, represents a permanent feature of the Florida citrus-producing States (Arizona, approximately 8 million 4/5-bushel industry and the last four seasons are California, Hawaii, Louisiana and cartons or an approximately $80 million typical. Texas) over a single shipping season potential business opportunity under The amount of citrus moved interstate would be 181,283,744 or less if the proposal. has declined steadily since the 1996–97

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season, with a larger decline in 2004– 05, when fruit production was affected by hurricanes. (See figure 1.)

The trends and changes occurring in Florida citrus production. Therefore, we • The Pert distributions generated the Florida citrus industry suggest that are making no changes in response to have mean values that differ from the the last four seasons are typical. The this comment. However, as shipping mean values of the data, because the 2006 Commercial Citrus Inventory for data for the 2006–07 season are now mean values of the data were Florida (USDA–NASS 2007) states the available, we use those data in improperly used as the modes for the following about the 2-year trend for Appendix 1 of the RMA that Pert distributions; Florida citrus fruit production: accompanies this final rule. • The actual use of Pert distributions, ‘‘Florida’s citrus acreage peaked again at In Section 9.3.3.2 of Appendix 1 of which is accomplished by fitting the 857,687 in 1996 but has been declining the RMA, we presented a determination discrete data to a Pert distribution and ever since. The 2006 total is 621,373, of the number of fruit shipped per 4⁄5- then finding the mean and standard down 17.0 percent in a 2-year period bushel carton. We used USDA-National deviation of the Pert distribution, is noted for hurricanes, diseases, and Agricultural Statistics Service (NASS) inefficient, not well defined, and has an urban development. The net change, a forecasts of fruit sizes to determine unknown error rate; and • loss of 127,182 acres, is the greatest in percentage distributions for the number The Florida Department of Citrus any non-freeze period and 2nd overall. of fruit that would be contained in each has data on the actual average numbers The Indian River District bore one-third 4 5 4⁄5-bushel carton, and then used the of fruit per ⁄ -bushel carton, which we of this loss. Removals out-numbered minimum, mean, and maximum from should have used. new plantings by a ratio of more than each of these distributions as parameters The commenter stated that these flaws 5:1. The 23,623 acres of new plantings in a Pert distribution to define the had an impact on a later section of the are the least recorded in any two-year analysis as well, Section 9.3.4, in which number of fruit of each variety per 4⁄5- period since 1970–71.’’ The last two bushel carton. our evaluation of the uncertainty sentences are especially germane to this associated with the number of fruit that The commenter made several discussion, as any rebound in Florida will move interstate from Florida relies comments about this technique, stating fresh citrus production would depend on the uncertainty in the Pert that: on new plantings. The Commercial distributions that the commenter stated • Citrus Inventory also states that acreage The USDA–NASS forecasts of fruit were incorrectly employed. decreases were reported for all 30 sizes are properly represented by a We agree that the analysis would have counties included in the survey, and discrete, rather than a continuous, been improved by the use of the actual that ‘‘only 197,027 acres (28.2 percent) distribution; average numbers of fruit per 4⁄5-bushel remain from the 697,929 reported in the • No basis was given for the use of carton. To improve the model in 1988 census.’’ This evidence indicates a Pert distributions to account for the Appendix 1 for this final rule, we have continued trend toward a decline in uncertainties in annual shipments; obtained from the Florida Department of

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Citrus the total number of 4⁄5-bushel size. Our use of these data makes using For some varieties, using real data cartons of fruit for each type and size of the USDA–NASS fruit size forecasts and increases the number of fruit moved fruit that was shipped to commercial the resulting Pert distributions interstate; for other varieties, using real citrus-producing States and the average unnecessary, thus addressing the data decreases that number. A summary number of fruit per bushel for each fruit commenter’s concerns. is provided in Table 1.

TABLE 1.—Q1: ANNUAL AMOUNT OF FLORIDA CITRUS BY VARIETY SHIPPED TO COMMERCIAL CITRUS-PRODUCING STATES

June 2007 Current Percentage Variety approach approach change

Grapefruit: ...... 5th percentile ...... 4.523,165 3,137,949 ¥31 Mean ...... 6,169,582 5,386,794 ¥13 95th percentile ...... 7,893,953 7,637,299 ¥3 Oranges: ...... 5th percentile ...... 20,948,908 13,525,400 ¥35 Mean ...... 25,081,498 19,351,870 ¥23 95th percentile ...... 29,425,176 25,158,470 ¥15 Temples: ...... 5th percentile ...... 91,786 103,295 13 Mean ...... 242,332 438,078 81 95th percentile ...... 392,884 773,018 97 : ...... 5th percentile ...... 241,718 395,323 64 Mean ...... 406,334 804,408 98 95th percentile ...... 575,434 1,210,151 110 Honey tangerines: ...... 5th percentile ...... 78,052,912 58,535,060 ¥25 Mean ...... 88,549,976 68,711,030 ¥22 95th percentile ...... 99,601,208 78,917,320 ¥21 Other tangerines: ...... 5th percentile ...... 43,050,856 34,651,600 ¥20 Mean ...... 47,975,284 42,753,630 ¥11 95th percentile ...... 52,948,348 50,701,440 ¥4

Taken together, these changes do not no account of the known fact of infected true prevalence of fruit with visible result in significant changes in the fruit being present. canker lesions of less than 0.004 (0.4 outputs of the model. The commenter suggested considering percent). The method presented by the In Section 9.3.3.3 of Appendix 1 to the issue in the following way: Suppose commenter indicates that a lot with a the RMA, we estimated the true that the fruit entering the inspection true prevalence of fruit with visible prevalence of symptomatic fruit in lots process is infected at an incidence rate canker lesions of 0.004 has a 97 percent that are inspected, found to be free of r, and this rate is the same for all fruit probability of being rejected. visible canker lesions, and approved to lots inspected. The inspection of n fruit We do not consider the prevalence of enter interstate commerce. The true will then fail to detect any infected fruit fruit with visible canker lesions in prevalence was based on the apparent with probability (1–r)n, and detect at rejected lots because those fruit are not prevalence (papparent), which was least one infected fruit with probability approved for shipment outside the adjusted to account for inspection 1–(1–r)n. The lot rejection rate for such quarantined area; this final rule sensitivity. We used the beta fruit will thus be 1–(1–r)n, independent explicitly prohibits reconditioning and distribution to estimate the apparent of the size of the lot. Accepted lots will resubmitting fruit for inspection (see the prevalence assuming a sample size of n be passed to market (still with infection discussion under the heading fruit that are examined by inspectors. rate r), and rejected lots will be dealt ‘‘Reconditioning’’ later in this Since we are estimating the true with in some other way. The commenter document). Furthermore, it is not prevalence in the lots of fruit that have stated that this meant that any infection necessary to know the prevalence of been inspected and found to be free of rate whatever can occur in the accepted symptomatic fruit produced in the visible canker lesions, x = 0, which lots; the controlling factor is likely to be quarantined area in order for APHIS means that the equation for the beta the economically acceptable rejection inspection to ensure that fruit shipped distribution we used was: rate. The commenter also raised issues outside the quarantined area has a high related to the disposition of lots that are probability of containing a low p = Beta(x+1, n¥x+1) = Beta(1, apparent not approved to enter interstate prevalence of symptomatic fruit. If the n+1) commerce. prevalence were to increase (or One commenter stated that such an The approach suggested by the decrease), APHIS inspection would estimate applies only to an isolated commenter provides results that are result in a higher (or lower) rate of lot single lot, with no further information equivalent to the procedure that we rejection. available, and does not apply to the used. Under the assumption used by the The commenter stated that the system we proposed, in which many commenter, the Beta distribution analysis was flawed because it did not lots would be evaluated. The method we used indicates that while address fruit contaminated with surface commenter stated that what is required any prevalence can theoretically occur bacteria, fruit with wounds that could is the average over many lots, where lots in accepted lots, 97 percent of lots be infected with citrus canker, and fruit are either accepted or rejected, and takes approved for shipment would have a with lesions smaller than 1 mm.

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For the reasons we discussed earlier much of the citrus that is moved to a provided for unlimited distribution of in this document under the headings county is consumed in the citrus- fruit from the quarantined are, subject to ‘‘Treatments and Surface Contamination bearing acreage. treatment and APHIS inspection. If we With Xac’’ and ‘‘Inspection and The commenter stated that, rather were able to determine that the Potential for Mature Fruit Without than using acreage to determine how assumption we used to determine how Visible Lesions to Serve as Pathway for much citrus is consumed in reasonably much fruit is consumed in reasonably Infection,’’ we have determined that close proximity to Xac host trees, we close proximity to Xac host trees these fruit are not likely to be an should use population. The commenter resulted in an underestimate, the epidemiologically significant pathway stated that consumption of citrus is conclusions drawn from the model for the introduction or spread of citrus definitely not uniform over the area of would not change: Some fruit with canker; in the case of wounded fruit or the county, but rather is concentrated visible canker lesions would be fruit with lesions smaller than 1 mm, we where the population is. The consumed in reasonably close proximity have also determined that such fruit are commenter stated that the approach of to Xac host trees. unlikely to occur in real-world prorating consumption by area fails With the modifications described conditions. Therefore, we do not entirely to account for the proximity of here, the model in Appendix 1 of the consider them in the model in a large fraction of the population to RMA that accompanies this final rule Appendix 1 to the RMA that citrus plant material (including has determined, with 95 percent accompanies this final rule. backyard trees). The commenter confidence, that the total number of In Section 9.3.3.4 of Appendix 1 to suggested using data from the RMA and citrus fruit shipped from Florida to 5 the RMA, we used a model to determine data on average household size for citrus-producing States (Arizona, the proportion of fruit with visible owner-occupied houses to estimate the California, Hawaii, Louisiana and canker lesions shipped to citrus-growing fraction of the population living in Texas) over a single shipping season areas within commercial citrus-growing owner-occupied houses with backyard would be 152,358,900 or less if States, based on the amount of citrus- citrus trees within counties containing unlimited distribution is permitted. The bearing acreage (including acreage for commercial citrus groves. model determined, with 95 percent backyard trees) in each citrus-producing The model used in the RMA makes a confidence, that the number of fruit county, the human population in each simplifying assumption that fruit with visible Xac lesions reaching those citrus-producing county and consumption occurs randomly 5 States in a single shipping season commercial citrus-producing State, and throughout the area of each county in would be 514,229 or less at the 1,000 the area of each citrus-producing which citrus is produced. Admittedly, fruit inspectional level. The model county. this is an imperfect estimate. However, further determined with 95 percent The commenter stated that we had the alternate simplifying assumptions confidence that the number of fruit with only considered in our analysis those presented by the commenter—that all visible Xac lesions reaching citrus- counties for which the production fruit consumed by residents of producing areas within those States in acreage is reported in the NASS households where citrus trees are a single shipping season would be 1,747 statistics, and that those counties or present is consumed in residential or less at the 1,000 fruit inspectional parishes with commercial production dooryards—would result in a great level. that are listed in the NASS statistics, but overestimate of the proportion of citrus As the original model did, the revised for which production acreage is not consumed in reasonably close proximity model indicates that, under unlimited reported to prevent inferences about to Xac host trees. Such an assumption distribution, fruit with visible canker individual farms, should have been would imply that residents of lesions would be moved interstate from included in the model. households in citrus-producing counties Florida into citrus-producing areas We agree with the commenter. While do not consume fruit indoors (at work, within commercial citrus-producing acreage is not available for these at school, in restaurants, or inside their States. Given that the evidence is not counties, NASS does report the number homes), and that they do not discard the currently sufficient to support a of farms in the counties. We have peel of the consumed fruit in a trash determination that fresh citrus fruit multiplied the number of farms by the can. For example, the commenter’s produced in a Xac-infested grove cannot mean farm size in the State in each of assumption results in an estimate that serve as a pathway for the introduction the counties in which farms were 13.6 percent of fruit consumed in of Xac into new areas, the model in reported to estimate the citrus- Arizona would be consumed and Appendix 1 to the RMA continues to producing acreage within each of those disposed in reasonably close proximity support our selection of Option 4. counties. We then added that acreage to to Xac host trees. the model. This results in an The commenter’s suggested Comments on the Proposed Regulatory approximately 10 percent increase in methodology thus assumes the Provisions and Other Comments the total citrus-producing acreage maximum possible exposure. The included in the model. Presidential/Congressional Commission Program Monitoring and Review We attempted to model backyard on Risk Assessment and Risk Four commenters requested that citrus acreage in order to determine Management observed that the use of APHIS put in place some type of what proportion of fruit is consumed in unrealistic maximum exposure program review if the provisions of the reasonably close proximity to Xac host scenarios impairs the scientific proposed rule were implemented. Three trees outside of commercial citrus credibility of risk assessment (CRARM requested that the program allowing the production areas. Having estimated the 1997b). interstate movement of fruit from a backyard citrus acreage, we added it to We are making no changes to the quarantined area under the conditions commercial citrus production acreage model in Appendix 1 of the RMA in described in the proposal be a pilot data in order to determine the total response to this comment. We believe program that would last for 2 years, after citrus-bearing acreage in the county. We the assumptions we used are reasonable, which a comprehensive performance then used the proportion of citrus- if imperfect. However, it is important to review could be conducted to determine bearing acreage in a county to the total note that the model was used to whether to extend the program. One acreage in a county to estimate how evaluate Option 2, which would have commenter requested that a program

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review be conducted after each of the and the conditions prevailing in areas sample sizes and define the inspection first two shipping seasons under the quarantined for citrus canker within the process, as different operational issues program. United States. exist in each packinghouse. APHIS recognizes the value of We appreciate this commenter’s periodic program reviews to assess Reconditioning concern. The compliance agreement performance and effectiveness. As In the proposed rule, we asked for under which a commercial discussed earlier, although the comments on reconditioning (i.e., packinghouse must operate in order to safeguards we proposed will be highly treating and culling fruit again after its be eligible to pack fruit for interstate effective at preventing the interstate initial treatment and culling). The movement under this final rule will spread of citrus canker, we are planning proposed regulations left open the issue provide a great deal of flexibility in monitoring and disease surveillance of allowing a lot of fruit that was defining lot size and meeting the activities to ensure that the program is initially found to be ineligible for inspection requirements. indeed effective. If we determine that interstate movement to be reconditioned One commenter asked whether the part or all of the program is not meeting and resubmitted for inspection. Because definition would mean that fruit from our expectations, we have the option to we had not thoroughly examined all several growers will be considered one amend the regulations accordingly. operational aspects of the lot by APHIS if the fruit is of the same Given this, we do not agree that it is reconditioning of fruit, we invited variety and packed on the same day. necessary to limit the amount of time comments on this topic. The commenter also asked whether the the program will be in place through the We received five comments on the definition would mean that, if regulations. issue, all of which supported allowing symptomatic fruit is found packed in a One commenter recommended that the reconditioning of fruit. None of the lot, then fruit from all the growers for APHIS provide funding for additional commenters provided guidance on any that variety packed on that day will be surveys for citrus canker in commercial specific circumstances in which ineligible for interstate commerce, even citrus-producing States to provide those reconditioning should be allowed. if the fruit from the groves of some States with evidence allowing them to After careful consideration of the growers did not have detectable lesions. declare freedom from citrus canker and issues involved in reconditioning, we Packinghouses are free to define their to quickly detect the disease if it have decided not to provide for lots as less than the amount of each spreads. The commenter stated that, in reconditioning of rejected fruit in this variety of fruit that is packed in 1 day the event that citrus canker spreads to final rule. One of the purposes of the if they wish. Under the compliance other States, there will be a need for APHIS inspection requirement is to give agreement that packinghouses will be similar regulations to protect those growers and commercial packinghouses required to have in place, States where the disease is not present. an incentive to supply fruit free of packinghouses must provide notice to We are providing funding for citrus visible canker lesions for interstate APHIS about the estimated sizes of the canker surveys in susceptible States. We movement. If we allow a lot of fruit that lots they are running; APHIS will not set have also worked with commercial has been rejected to be reconditioned lot sizes itself. Regardless of the size of citrus-producing States to develop and resubmitted for inspection, the a lot, APHIS will inspect the lot at a rate emergency response guidelines should incentive to provide fruit free of visible sufficient to detect, with a 95 percent citrus canker be found in those States, canker lesions substantially diminishes. level of confidence, any lot of fruit and we will continue to review and Reconditioning could also provide the containing 0.38 percent or more fruit refine those guidelines to ensure that packinghouse with a greater incentive to with visible canker lesions. they will be effective in the event of a ‘‘take its chances’’ in submitting a lot of If any symptomatic fruit are found in detection. fruit that may contain visible canker a lot, as the lot has been defined by the The regulations presently in place lesions for inspection. Therefore, packinghouse in accordance with the provide standards and requirements allowing reconditioning could weaken definition of lot in § 301.75–1 and the sufficient to prevent the spread of citrus the protection provided by the APHIS provisions of the compliance agreement, canker from any area in the United inspection. Additionally, if fruit then all fruit in that lot will be ineligible States that might be quarantined for undergo surface disinfectant treatment for interstate commerce, regardless of citrus canker, not just for the State of multiple times, residues of the whether the lot is composed of fruit Florida. disinfectant may exceed EPA tolerances; from one or from several sources. This One commenter stated that, before it would be difficult to control how provides an incentive for growers and implementing the packinghouse- many times fruit came into contact with packinghouses to ensure that each lot centered approach for regulating fruit surface disinfectants if we allowed contains no fruit with detectable described in the proposed rule, APHIS reconditioning. For these reasons, we lesions. should propose and seek review for the are not allowing reconditioning in this One commenter stated that the approach through the North American final rule. proposed definition of lot is vague and Plant Protection Organization (NAPPO) Definition of Lot not consistent with the definition of lot and the International Plant Protection in the IPPC’s Glossary of Phytosanitary Convention (IPPC). We proposed to define the term lot as Terms.7 The commenter recommended NAPPO facilitates cooperation and ‘‘The inspectional unit for fruit that the definition be clarified, by the development of standards among the composed of a single variety of fruit that variety, in the final rule. national plant protection organizations has passed through the entire packing While APHIS always considers the of Canada, the United States, and process in a single continuous run not IPPC Glossary when determining how to Mexico, and the IPPC performs a similar to exceed a single workday (i.e., a run function for the wider international started one day and completed the next 7 See the International Glossary of Phytosanitary community. Neither body has the is considered two lots).’’ Terms (2007), which is International Standard for authority to set regulatory policy for the One commenter asked that the rule Phytosanitary Measures (ISPM) Number 5. To view this ISPM on the Internet, go to http:// United States. We conducted our risk allow commercial packinghouses www.ippc.int/IPP/En/default.jsp and click on the analyses and developed the proposed flexibility and discretion in working ‘‘Approved standards’’ link under the ‘‘Standards rule on the basis of the available science with APHIS to define specific lot and (ISPMs)’’ heading.

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define a term, our use of the term ‘‘lot’’ more total marbles in the barrel, the level of confidence, any lot of fruit in the proposal is consistent with U.S. proportion of white marbles to black containing 0.38 percent or more fruit citrus industry practices; using another marbles is the same in both the barrel with visible canker lesions. This is the term would likely provoke unnecessary and the keg. Similarly, we have level of inspection that we will be confusion. There is no phytosanitary or designed the sampling procedure to conducting as of the publication of this statistical reason to set lot sizes by detect fruit with visible canker lesions final rule. However, we also included variety. at a targeted prevalence of 0.38 percent; provisions allowing the inspection of We stated in the proposal that we while we do not know the prevalence of another quantity that gives a statistically intend to inspect fruit at a rate of fruit with visible canker lesions in any significant confidence of detecting the inspection sufficient to detect, with a 95 lot, the prevalence at which our disease at a level of infection to be percent level of confidence, any lot of sampling protocol will detect fruit with determined by the Administrator. In the fruit containing 0.38 percent or more visible canker lesions is fixed. Thus, preamble to the proposed rule, we fruit with visible canker lesions. This is randomly sampling 1,000 fruit from a stated that ‘‘If at some time in the future equivalent to randomly sampling 1,000 lot is appropriate for both lots composed conditions warrant changing this rate of fruit per lot. of 50,000 fruit and lots composed of inspection, APHIS would provide for One commenter stated that it is 200,000 fruit, because the targeted public participation in that process essential that APHIS establish the prevalence of 0.38 percent or more fruit through the publication of a notice in maximum lot size that could be run with visible canker lesions is the same the Federal Register.’’ To make our with only 1,000 fruit inspected. The for each lot. process for changing the inspection commenter stated that leaving the It should be noted that, in cases where level clear in the regulations, this final establishment of a lot size to fruit cannot be randomly sampled (for rule adds a footnote to the regulations packinghouse discretion creates the example, when fruit has already been that includes the information regarding potential for a wide variation in the packed in boxes for shipping), the other sampling level and the number of fruit actually cleared by inspection of more than 1,000 pieces of information that appeared in the APHIS inspectors. The commenters fruit may be necessary in order to preamble to the proposed rule. stated that it is obvious that a lot size inspect the lot at a rate sufficient to of 200,000 pieces of fruit is considerably detect, with a 95 percent level of Dooryard Fruit different than one of 50,000, because the confidence, any lot of fruit containing We stated in the proposal that our potential for infected pieces of fruit to 0.38 percent or more fruit with visible proposed provisions would allow any slip through the treatment and canker lesions. We will communicate Florida citrus growers, including inspection steps is four times as great in inspection requirements to commercial, gift fruit, and dooryard the latter case. packinghouses as part of the growers, to move their fruit interstate to It may seem counterintuitive that implementation of the compliance States other than commercial citrus- randomly sampling the same number of agreements. producing States provided they comply fruit for a lot composed of 50,000 fruit One commenter stated that the with the conditions discussed in the and a lot composed of 200,000 pieces of statistical sampling procedure described proposed rule. Dooryard growers are fruit provides the same confidence of in the proposed rule was not typically homeowners who have citrus detecting fruit with visible canker appropriate for lots packed by gift fruit trees in their yards and wish to ship the lesions at the 0.38 percent prevalence packers, as such lots are very different fruit from those trees interstate to level. However, as discussed in Section from large-scale commercial lots. friends or family. The regulations in 9.3.3.3 of Appendix 1 to the RMA, the We intend to inspect fruit at a rate of place before the publication of this final hypergeometric sampling algorithm inspection sufficient to detect, with a 95 rule required fruit moved interstate to (which assumes that the fruit is sampled percent level of confidence, any lot of originate from a grove that had been without being returned to the lot, thus fruit containing 0.38 percent or more inspected and found to be free of citrus ensuring that the same piece of fruit is fruit with visible canker lesions. This is canker and required vehicles, not inspected twice) indicates that equivalent to randomly sampling 1,000 equipment, and other articles used in randomly sampling 1,000 fruit is fruit per lot for most lots. However, for the grove to be treated upon leaving the adequate to detect, with a 95 percent smaller lots, the number of fruit that grove. Since dooryard growers could not level of confidence, any lot of fruit must be randomly sampled to detect, comply with these requirements, the containing 0.38 percent or more fruit with a 95 percent level of confidence, a interstate movement of dooryard fruit with visible canker lesions for any lot of lot of fruit containing 0.38 percent or was effectively halted. 100,000 fruit or more. For lot sizes less more fruit with visible canker lesions One commenter submitted comments than 100,000 fruit, randomly sampling could be less than 1,000, as discussed in on the regulations in place before the 1,000 fruit actually gives better than 95 Section 9.3.3.3 of Appendix 1 to the publication of this final rule, stating that percent confidence of detecting the RMA. This principle may be applicable dooryard growers should be allowed to prevalence of 0.38 percent. to gift fruit lots, which are sometimes ship fruit interstate under these The reason this is true can be seen by smaller than 1,000 fruit. For lots larger conditions: imagining a large barrel and a small keg, than 1,000 fruit, the statistical • Inspectors could certify dooryard both of which are filled with marbles. principles behind determination of how trees as free of citrus canker upon The barrel holds a million marbles, many fruit must be inspected to achieve request. while the keg only holds 10,000 this detection level apply regardless of • Surface disinfectant treatment marbles. In both the barrel and the keg, whether the fruit is from a gift packer or would not be required if the tree was though, 99.9 percent of the marbles are a larger packinghouse. certified as free of citrus canker. white and 0.1 percent are black. If one We are making one change to clarify • Dooryard fruit would be permitted randomly samples the same number of the requirement for the inspection level. to be moved only to States other than marbles from both the barrel and the The proposed rule stated that we would commercial citrus-producing States. keg, one has the same chance of drawing require the number of fruit to be • The number of boxes a dooryard a black marble from either the barrel or inspected to be the quantity that is grower could ship in a season would be the keg. Even though there are 100 times sufficient to detect, with a 95 percent restricted to 20.

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The regulations promulgated in this compliance agreement described in the agreement will also contain (but not to final rule do not distinguish between proposal would pose difficulties for be limited to) specific provisions dooryard growers and commercial smaller packinghouses, including the pertaining to: growers for the purposes of moving fruit requirements for: • Access to the facility, and to interstate. Anyone can move fruit • Notice of estimated lot size and run necessary records and documents by interstate if he or she has the fruit times; APHIS inspectors; • packed at a commercial packinghouse Need for notice when APHIS • Means by which lots are designated and treated and inspected as described inspectors are not present on a regular and notice of estimated lot sizes and run in the amended regulations. basis; • times; The approved disinfectants listed in Need for notice when there are • Need for notice when APHIS the regulations in § 301.75–11(a) reduce significant changes in the amount of inspectors are not present on a regular numbers of Xac cells to low or fruit being packed; basis; • Provisions for holding fruit when undetectable levels on citrus fruit • Need for notice when there are packing is done at a time when an moving interstate from citrus canker significant changes in the amount of quarantined areas. The APHIS APHIS inspector is not present; and • Hours of coverage for APHIS fruit being packed; inspection can detect, with a 95 percent • Conditions (access to fruit, lighting, level of confidence, any lot of fruit packinghouse inspections. The commenter noted that packages safety, etc.) that must be met in order for containing 0.38 percent or more fruit APHIS inspectors to carry out the with visible canker lesions. These of gift fruit often incorporate citrus of multiple varieties, and that random required inspections; restrictions are necessary to address the • sampling of packed boxes is not an Provisions for handling and storage risk associated with the interstate of fruit, including provisions not movement of fresh citrus fruit from a option at gift fruit packinghouses, since allowing the movement of any part of a quarantined area. We expect that some once the fruit is boxed, the boxes are lot from the packinghouse until APHIS commercial packinghouses will glued and labeled for shipping. inspection is complete; establish processes under which The commenter expressed specific • Hazard-free access to treatment dooryard fruit can be treated and concerns about the sporadic nature of areas so that APHIS inspectors can inspected to allow it to move interstate. operations for many smaller Two commenters objected to allowing packinghouses, which run fruit when monitor the concentrations of chemicals there are orders to be filled for most of used for fruit treatment; dooryard fruit to be moved interstate • from a quarantined area. One noted that the year and then run constantly during Provisions for holding fruit when the RMA considered the risk associated the busy season in December. Since we packing is done at a time when an with commercially packed fruit, but we proposed to require that an APHIS APHIS inspector is not present; and • proposed to allow the movement of inspector would have to be present Hours of coverage for APHIS dooryard fruit under the same whenever a packinghouse was packinghouse inspections. conditions. The other commenter stated operating, the commenter was Using the compliance agreement to that there is nothing in the proposed concerned that the gift fruit provide conditions for implementing rule that provides any degree of packinghouses might not be able to the regulations will give APHIS some confidence that dooryard fruit will not provide notice of the need for an flexibility to accommodate be shipped from Florida and that in all inspector during the slow times and packinghouse procedures. For example, likelihood dooryard fruit will not be then might be left without the services in the compliance agreement, we will treated with an approved surface of an inspector during busy times. allow commercial packinghouses to disinfectant in a packinghouse. Another commenter also expressed work with APHIS to determine methods The RMA addressed the risks general concerns about the availability for sampling the fruit. For gift fruit associated with commercially packed of inspectors. packers, we would sample each lot of fruit; accordingly, we are only allowing We appreciate the commenter fruit before it is packed into boxes. Once the movement of dooryard fruit if it is bringing these issues to our attention. It a lot is inspected by APHIS and commercially packed, treated, and has always been our intention to design approved to enter interstate commerce, inspected by APHIS. Like commercial a system suitable for both large and fruit from the lot can be combined with fruit growers, dooryard fruit growers small commercial packinghouses. We fruit from other lots that have been have an incentive to supply fruit that is are aware of the packing patterns of the inspected and approved, in any way free of visible canker lesions, as any lot smaller packinghouses and are planning that is convenient for the packer; all that of fruit that is found through inspection our inspection staffing accordingly. We is required is that all the fruit so to contain fruit with visible canker can address all the issues raised by the combined be from lots that have been lesions will be ineligible for interstate commenter in the context of the inspected by APHIS and approved to movement. We will conduct outreach compliance agreement, which will enter interstate commerce. provide a great deal of flexibility in how efforts to ensure that dooryard growers Boxes or Other Containers are aware of the new requirements. an individual operation can fulfill this final rule’s treatment and inspection We proposed that, in order to be Gift Fruit Packers and Compliance requirements. moved interstate, regulated fruit would Agreements As discussed in the proposed rule, in have to be packaged in boxes or other One commenter, a gift fruit packer, the compliance agreement, the owner or containers that are approved by APHIS stated that the proposed regulations operator of the packinghouse will agree and that are used exclusively for were written primarily for the 50 large to treat fruit to be moved interstate with regulated fruit to be moved interstate. citrus packing operations registered one of the approved treatments One commenter, a gift fruit packer, with the State of Florida rather than the according to the procedures specified in was concerned that the boxes used by 92 small citrus packinghouses that are § 301.75–11, and to see that this fruit is such packers are not similar to the boxes also registered with the State. The packed only in boxes marked in used by large packinghouses. The commenter specifically stated that accordance with the requirements in commenter recommended that the issue several of the provisions of the § 301.75–7(a)(6). The compliance be worked out somehow, perhaps by

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exempting gift fruit from the efforts to ensure that fruit that is moved or other containers that are clearly requirement. interstate meets all the requirements in marked with both the limited permit APHIS has the option to approve any the regulations. and distribution statements. boxes or containers. We are not aware Nine commenters did not object to the In this final rule, we are also of any boxes used by gift fruit packers labeling change, but stated that the fact providing that fruit that is not eligible that would not be approved. The use of that their current inventory of boxes and for a limited permit may not be packed the limited permit statement on boxes or other containers does not include the in boxes that are marked with only the other containers will indicate that the ‘‘Limited Permit: USDA–APHIS–PPQ’’ distribution statement. This means that container has been approved by APHIS. statement would pose a problem for either fruit are eligible for a limited them in complying with the new permit, in which case they must be Limited Permits and Marking of Boxes regulations. One of the commenters, a packed in boxes that are marked with or Other Containers representative of Florida commercial the limited permit and distribution We proposed to require that the boxes packinghouses, stated that the current statements, or ineligible, in which case or other containers in which regulated inventory of boxes and other containers neither of these statements may appear fruit is packaged for interstate with the old markings is worth $2 to on the boxes. Fruit that is not eligible movement would have to be clearly $2.5 million. These commenters for a limited permit and is moved for marked with the statement ‘‘Limited requested that we allow them to use up intrastate sale or for export can be Permit: USDA–APHIS–PPQ. Not for their current inventory of containers packed in the same boxes or other distribution in AZ, CA, HI, LA, TX, while box and container manufacturers containers, including bags, as fruit that American Samoa, Guam, Northern retool their equipment to produce is eligible for interstate movement, as Mariana Islands, Puerto Rico, and Virgin containers with the new statement. long as the limited permit and Islands of the United States.’’ (The We appreciate the concerns of these distribution statements are removed or regulations in place before the commenters as well. We note that this obscured (through means such as publication of this final rule did not final rule requires only that the boxes or opaque ink or a sticker) before the fruit include the ‘‘Limited Permit: USDA– other containers approved by APHIS be is shipped. APHIS–PPQ’’ portion of that statement.) marked with the statement, not that the As mentioned earlier in this The proposed provisions also stated that statement be printed directly on the document under the heading ‘‘Pest Risk only fruit that meets all of the boxes or other containers; if commercial Assessment and Risk Management requirements of the section may be packinghouses have inventories of Analysis,’’ this final rule also requires packed in boxes or other containers that boxes or other containers without the the limited permit and distribution are marked with the above statement. ‘‘Limited Permit: USDA–APHIS–PPQ’’ statements to be printed on any We proposed these additional statement, they can add that statement shipping documents accompanying the provisions in order to help ensure that through means such as a sticker or fruit. only fruit that has been handled in stamp, as long as the statement is clearly Movement of Regulated Fruit Through accordance with all of the requirements marked. described in § 301.75–7 would be However, it is not practical to modify Commercial Citrus-Producing States packaged in boxes or other containers bags of fruit in this manner, as the The regulations do not currently bearing the limited permit statement. distribution statement printed on bags is provide for the movement of regulated One commenter stated that the use of often small or attached to the bag, and fruit through commercial citrus- the term ‘‘Limited Permit’’ on shipments the limited permit statement often producing States for ultimate shipment of gift fruit would be unnecessarily cannot be added to it. For this reason, to other States (i.e., transshipments). We legalistic in the context of gift fruit we are temporarily allowing fruit to be did not propose to provide for such shipments, which are addressed to packed for interstate movement in bags movement in the proposed rule. specific people in States other than if those bags are clearly marked with the One commenter requested that the commercial citrus-producing States. The distribution statement and if those bags final rule provide for such movement. commenter suggested that we either are then packed in a box that is marked The commenter stated that, while the retain the language that had been in with both the limited permit statement concerns of commercial citrus- place at the time the proposed rule was and the distribution statement. Fruit producing States should be addressed published or allow gift fruit shipments will only be allowed to be packed in through safeguards, the commenter to use language like ‘‘Please don’t take bags that are marked with the believed allowing transshipments with any of your fruit to citrus-producing distribution statement if that fruit is suitable safeguards is consistent with areas in the United States, which are eligible for interstate movement. the National Plant Board’s Principles of AZ, CA, HI, LA, TX, American Samoa, Because the bags must be packed in Plant Quarantine. Another commenter Guam, Northern Mariana Islands, Puerto boxes that are marked with both the stated that the proposal and RMA did Rico, and the U.S. Virgin Islands.’’ limited permit and the distribution not address transshipments via We appreciate the commenter’s statements, and because bagged fruit is consumer modes. concerns and agree that the risk of gift not unloaded from the boxes in which We did not consider the risk fruit shipments being sent to a it is shipped until it reaches the point associated with transshipment in the commercial citrus-producing State is of sale, we believe that this requirement proposed rule. We would need to likely to be extremely low. However, will provide the same level of protection determine the risk associated with adding the ‘‘Limited Permit: USDA– against illegal movement of fruit from transshipment and how it could be APHIS–PPQ’’ statement to the boxes or the quarantined area as the requirement mitigated before adding provisions for other containers in which regulated fruit in the proposed rule, while allowing transshipment to the regulations. is moved interstate allows us to ensure some flexibility for regulated parties. Therefore, it is not appropriate to that the statement appears only on As the commenters requested, this provide for transshipment in this final boxes or other containers filled with exemption is temporary; it will expire rule. We plan to examine the risks fruit that is eligible for interstate on August 1, 2008. After that date, all associated with transshipment and, if movement. Therefore, we consider this fruit intended for interstate movement our examination indicates that statement to be an essential part of our will be required to be packed in boxes transshipment can be accomplished

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safely under certain conditions, propose small percentage of those seedlings are current narrow margins that citrus to provide for it in a future rulemaking. themselves infected with citrus producers enjoy, and that monitoring greening. In response to this evidence, and surveying utilizing very high-cost With Foliage we have also amended the Federal order labor would be very expensive. One The regulations require regulated fruit to prohibit the movement of seed for commenter stated that the current moved interstate from a quarantined planting from areas quarantined for canker-free status of California gives area to be free of leaves, twigs, and other citrus greening. that State an advantage in the fresh plant parts, except for stems that are less We are currently evaluating the citrus marketplace for exports. than one inch long and attached to the preliminary evidence to determine We do not expect that the conditions fruit. We did not propose to change this whether seed contained in fruit may in this final rule will result in the requirement. serve as a pathway for the transmission introduction of citrus canker into other One commenter requested that the of , and, if so, commercial citrus-producing States, as final rule allow the interstate movement what restrictions may be appropriate for the final rule retains the prohibition of of kumquat fruit with decorative foliage the movement of fruit from areas the shipment of regulated fruit from a to States other than commercial citrus- quarantined for citrus greening. Any quarantined area to other commercial producing States under a limited permit regulatory action we may take in citrus-producing States. For that reason, and with product inspection. The response to this evidence would be we have not analyzed the possible commenter stated that such movement taken separately from this rulemaking, effects of a citrus canker introduction on would pose no appreciable risk, as this which addresses the risk posed by the California citrus, including on foliage is resistant to citrus canker and interstate movement of citrus fruit from California citrus producers’ ability to not used for propagation. areas quarantined for citrus canker. export their fruit. Foliage is subject to infection by The use of copper sprays is already an citrus canker, and thus the risk posed by Miscellaneous Change industry practice to control other pests foliage would need to be evaluated The regulations in § 301.75–7(a)(5) of citrus fruit. Further, copper sprays, before we could determine whether to have required that all vehicles, isolation fences, and spraying for allow its movement from the equipment, and other articles used in disinfection, while not required by quarantined area. We did not address providing inspection, maintenance, APHIS, are considered to be best the risk posed by citrus foliage in any harvesting, or related services in a grove industry practices that help to prevent of the documentation accompanying in which regulated fruit are produced infestation by other pests. Incorporating this proposed rule. Therefore, it would for interstate movement must be treated best management practices into be inappropriate to provide for the in accordance with § 301.75–11(d) upon production practices benefits both the movement of citrus foliage in this final leaving the grove. This paragraph has individual producer and the industry as rule. also provided that all personnel who a whole. In response to the comment, we plan enter the grove or premises to provide Grove surveys should be conducted to examine the risks associated with the these services must be treated in regardless of the citrus canker status of interstate movement of citrus foliage accordance with § 301.75–11(c) upon any grove because early detection of any from quarantined areas. If we decide leaving the grove. We did not propose disease (such as citrus canker, citrus that the movement of citrus foliage can to change these requirements in the greening, citrus variegated chlorosis, be accomplished safely under certain proposal. However, these requirements and other diseases) is key to successful conditions, we would propose to are inappropriate for the packinghouse- eradication of the disease. provide for it in a future rulemaking. centered approach that we are adopting One commenter, from Florida, in this final rule. Accordingly, this final estimated that the spread of canker has Citrus Greening rule removes paragraph (a)(5) from resulted in an additional 20 percent of One commenter stated that we should § 301.75–7. It should be noted that Florida’s total fresh citrus groves being not put in place any rule allowing the growers will still have an incentive to declared ineligible to ship fruit interstate movement of fruit from perform such treatments, as they would interstate under the regulations that Florida until we have a program in help ensure that fruit produced in the were in place before the publication of place to address the risk posed by citrus grove remains free of visible canker this final rule. That 20 percent, the greening. lesions and thus eligible for interstate commenter stated, represents Restrictions on the movement of movement. approximately 8 million 4⁄5-bushel certain articles due to the presence of cartons or an approximately $80 million citrus greening have been put in place Comments on the Preliminary potential business opportunity under under separate Federal orders; the Regulatory Impact Analysis and Initial the proposal. initial order was issued on September Regulatory Flexibility Analysis Another commenter cited this figure 16, 2005, and was updated on May 3, In accordance with the requirements and compared it to what the commenter 2006. We further updated our of Executive Order 12866 and the stated was the billion-dollar California restrictions relating to citrus greening Regulatory Flexibility Act, we prepared fresh citrus industry, indicating that the through a Federal order issued on a preliminary regulatory impact analysis latter should not be risked for the November 2, 2007, to expand the areas and initial regulatory flexibility act benefit of the former. This commenter under quarantine due to the presence of analysis for the proposed rule. also noted that we characterized as citrus greening and the areas under Two commenters stated that this small the changes to the supply of quarantine due to the presence of the analysis was incomplete as it did not Florida fresh citrus in States other than Asian citrus psyllid, a vector for the analyze the potential effects of the commercial citrus-producing States spread of citrus greening. introduction of citrus canker into resulting from additional shipments that We have received reports of commercial citrus-producing States would be newly eligible to move preliminary scientific evidence other than Florida. One commenter interstate under the proposed rule. The indicating that, when seedlings are stated that costs involved with copper commenter asked why the rule was generated from seed that is taken from sprays, isolation fencing, and spraying being rushed into place given the plants infected with citrus greening, a for disinfection could take away the precedent the rule sets and the fact that

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stakeholders would not be able to would have to take the revenue gained proposed rule’s potential effects on the review the peer review comments before by these means into account. human environment. the publication of the final rule. With regard to the second One commenter stated that the EA While the change from grove commenter’s point, the comparison should examine the potential inspections to APHIS packinghouse given is between the incremental benefit environmental impacts of the inspections of finished fruit will allow to the Florida fresh citrus industry and introduction of citrus canker into Florida growers to maintain the quantity the total value of the California fresh another commercial citrus-producing of fresh citrus that is eligible for citrus industry. The commenter did not State, should APHIS be incorrect in its interstate movement, and may result in quantify what costs the commenter assessment of the potential for canker to an increase in that quantity, we do not expected the California fresh citrus be established in citrus-producing States expect that interstate shipments of fresh industry to incur as a result of the outside of Florida under the proposed citrus will increase by a proportion proposed rule, which is the salient regulations. equivalent to the potential production point. We do not expect the regulations Because this final rule prohibits the for the fresh market from groves promulgated in this final rule to allow interstate movement of regulated fruit to previously prohibited from shipping the spread of citrus canker to California, commercial citrus-producing States, we interstate due to citrus canker. Rather, and thus we expect the final rule’s effect do not expect the final rule to result in APHIS expects the quantities of fresh on the California fresh citrus industry to the introduction or establishment of citrus shipped interstate from Florida to be small as well. citrus canker in those States. Therefore, reflect historic demand for Florida fresh In addition, while the benefits to we did not assess the environmental citrus. Over the last decade, the Florida growers and packers are impact that would be associated with proportions of Florida fresh citrus expected to be small in the short term, such an introduction. the RMA indicates that it will be very shipped within Florida, to other States, Effective Date and internationally have remained fairly hard to certify citrus groves as canker- constant. Based on historical data from free in Florida in the future. In the long This is a substantive rule that relieves 1997–98 to 2006–07, an average of 10 run, promulgating this rule may be restrictions and, pursuant to the percent of Florida’s commercially expected to provide additional benefits provisions of 5 U.S.C. 553, may be made packed fresh citrus was shipped over the existing regulations, while effective less than 30 days after intrastate (within Florida) each season, continuing to prevent the interstate publication in the Federal Register. 52 percent was shipped to other States spread of citrus canker. Immediate implementation of this rule each season, and 39 percent was One commenter, noting that we stated is necessary to provide relief to those exported to other countries each season. that currently underutilized packing persons who are adversely affected by Based on the commenter’s estimation equipment may be utilized for dooryard restrictions we no longer find of an additional 20 percent of Florida’s fruit under the proposed rule, stated warranted. The shipping season for fresh citrus groves regaining interstate that no data are given regarding how Florida citrus fruit is in progress. shipment eligibility under this final much idle capacity exists. Making this rule effective immediately rule, and given historic distribution As the volume of fruit moved will allow interested producers and patterns, we project as an upper bound interstate has declined, approximately others in the marketing chain to benefit that the shipment of fresh citrus to 21 citrus packinghouses have shut down during this year’s shipping season. States other than commercial citrus- in Florida since the 2001–02 season; we Therefore, the Administrator of the producing States is likely to be closer to do not have data on how many of them Animal and Plant Health Inspection 4.3 million 4⁄5-bushel cartons per could still be used for packing citrus Service has determined that this rule season. fruit. Our reference to underutilized should be effective upon publication in Additionally, groves that have been packing equipment refers mainly to the Federal Register. ineligible to produce fruit for interstate smaller operations, such as gift packers, movement under the regulations in which are better suited to treating and Executive Order 12866 and Regulatory place before the publication of this final packing small quantities of citrus. Flexibility Act rule have been ineligible due to the Growers of dooryard fruit who wish to This rule has been reviewed under presence of citrus canker. It is ship their fruit interstate are required to Executive Order 12866. The rule has reasonable to assume that some have this citrus treated and inspected been determined to be significant for the proportion of the fruit produced in under the same provisions required by purposes of Executive Order 12866 and, those groves will have visible canker commercial citrus producers. As such, therefore, has been reviewed by the lesions and thus be ineligible for these growers will turn to facilities Office of Management and Budget. interstate movement, further lowering equipped to comply with the We are amending the citrus canker the potential increase in interstate regulations, such as gift packers. While regulations to modify the conditions shipments. Florida fresh citrus the cost of shipping citrus under these under which fruit may be moved shipments are also still subject to the provisions could be substantial, interstate from a quarantined area. We market demand for fresh citrus in States evidence indicates that dooryard are eliminating the requirement that the other than commercial citrus-producing shipments are made purely for the groves in which the fruit is produced be States. intrinsic value of sharing the fruit with inspected and found free of citrus The commenter also suggests that the family and friends. As noted earlier in canker, and instead requiring that every potential increase in revenues could be this document, the interstate movement lot of fruit produced in the quarantined $80 million. However, the $80 million of dooryard citrus from a quarantined area be inspected by APHIS at a figure assumes that fruit produced from area was effectively prohibited under packinghouse operating under a these same groves during past seasons the regulations in place before the compliance agreement and found to be were considered to be unmarketable. publication of this final rule. free of visible symptoms of citrus Some of that fruit would have been canker. We are retaining the diverted to the processing sector or Environmental Assessment requirement that the fruit be treated shipped both intrastate and We prepared an environmental with a surface disinfectant and the internationally. The increase in revenue assessment (EA) documenting the prohibition on the movement of fruit

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from a quarantined area into the final rule. In contrast, fresh citrus trees outnumbering new plantings commercial citrus-producing States. utilization in California accounts for 73 by a ratio of more than 5:1, there is little These changes will relieve some percent of total citrus production. In indication that production will rebound restrictions on the interstate movement Texas and Arizona, fresh utilization within the next few years. of fresh citrus fruit from Florida while accounts for approximately 66 and 58 The major citrus varieties produced in maintaining conditions that will help percent of total production, Florida are early-, mid-, and late-season prevent the artificial spread of citrus respectively. It is assumed that nearly varieties, red and white seedless canker. all Louisiana citrus production is grapefruit, early tangerines, honey For this final rule, we have prepared primarily utilized on the fresh market. tangerines, temples, and tangelos. an economic analysis. The analysis, This final rule continues to prohibit the Although approximately 89 percent of which is summarized below, addresses movement of fresh citrus fruit from all Florida citrus is intended for the economic impacts of the proposed new Florida to other commercial citrus- processed market, the share of protocol for treatment and inspection of producing States. The measures in this production that is processed is highly citrus fruit intended for the fresh final rule are designed to ensure dependent upon the variety. market. Expected benefits and costs are protection of the citrus industries in Approximately 95 percent of all Florida examined in accordance with Executive these States from the introduction of orange production is intended for the Order 12866. Possible impacts on small citrus canker and the increased processing sector; whereas, nearly 68 entities are considered in accordance production costs and loss of fresh fruit percent of Florida tangerine production with the Regulatory Flexibility Act. markets that would result if citrus is utilized on the fresh market. During Copies of the full analysis are available canker were to be introduced in those the 2005–06 season, nearly 36 percent of on the Regulations.gov Web site (see States. Florida grapefruit production was footnote 1 at the beginning of this final utilized on the fresh market. During the rule). Overview of the U.S. Citrus Industry previous season, the proportion of Section 301.75–5 of the regulations The total value of U.S. citrus Florida grapefruit utilized on the fresh lists the designated commercial citrus- production increased by 16 percent market was approximately 58 percent, producing States as American Samoa, during the 2005–06 season over the suggesting that the post-hurricane Arizona, California, Florida, Guam, previous season from $2.3 billion to higher prices for fresh grapefruit led to Hawaii, Louisiana, the Northern nearly $2.7 billion. These gains in value a diversion of Florida grapefruit from Mariana Islands, Puerto Rico, Texas, reflect increased values for processed the processing sector to the fresh and the U.S. Virgin Islands. Of these 11 utilization for most varieties of citrus in market. The reduced rate for fresh commercial citrus-producing States, the United States with the exception of market share during the 2005–06 season only 6 States received fresh citrus grapefruit, which declined in overall may suggest a return to a more normal interstate shipments from Florida value by 4 percent. fresh market share of about 40 percent. during the 2004–05 and 2005–06 Florida is the largest citrus producer The major citrus varieties produced in seasons: Arizona, California, Louisiana, in the United States, accounting for California are navel and Valencia Puerto Rico, the U.S. Virgin Islands, and approximately 68 percent of U.S. oranges, grapefruit, tangerines, and Texas. As of August 1, 2006, these 6 production during the 2005–06 season. lemons. Approximately 73 percent of States no longer receive fresh citrus California produced approximately 28 California citrus was utilized on the shipments from Florida. In this analysis, percent of the citrus in the United States fresh market during the 2005–06 season, U.S. commercial citrus-producing States during the same period, and production including nearly 72 percent of other than Florida are referred to as in Texas and Arizona comprised the California’s oranges (making California other commercial citrus-producing remaining 4 percent. The tumultuous the largest U.S. producer of fresh-market States. hurricane season of 2004, which oranges), 88 percent of the State’s The overall objective of this final rule included four hurricanes that crossed grapefruit, 75 percent of its tangerines, is to continue to prevent the spread of Florida within a 2-month period, caused and 72 percent of its lemons. citrus canker to other commercial citrus- significant production losses to The citrus varieties produced in Texas producing States, while relieving Florida’s citrus industry and was largely during the 2005–06 season were restrictions on Florida citrus producers, to blame for the 42 percent decline of grapefruit, Valencia oranges, and namely, the requirement for interstate total utilized production in the United midseason oranges. Fresh production movement of citrus fruit that every tree States between the 2003–04 and 2004– accounted for approximately 67 percent in the grove in which the fruit is grown 05 seasons. Total value of production in of total production. Valencia and be inspected, and that the grove be Florida citrus fruits showed signs of midseason orange production was found to be free of citrus canker not improvement during the 2005–06 destined primarily for the fresh market, more than 30 days before the beginning season with a 30 percent increase over accounting for 79 percent of total of harvest. Under the final rule, the the previous season; the increase was production. Also, 62 percent of citrus fruit will be treated and inspected largely attributable to higher on-tree grapefruit production in that State was at the packinghouse prior to interstate prices for both processed and fresh utilized on the fresh market. movement. Based on the qualitative utilization rather than an increase in Arizona produces Valencia and navel findings of this economic analysis, we production. oranges, grapefruit, tangerines, and expect the net economic impact of the Evidence suggests a continued trend lemons. Approximately 58 percent of final rule to be positive. toward a decline in Florida citrus Arizona citrus was utilized on the fresh While citrus produced in Florida is production. The recent 2006 market during the 2005–06 season, primarily intended for the processed Commercial Citrus Inventory for Florida including 52 percent of the State’s market, citrus produced in California, reported a 17 percent decline in 2006 orange production, 65 percent of its Texas, Arizona, and Louisiana is largely over the previous year with the total tangerine production, 55 percent of its intended for the fresh market. commercial citrus acreage in Florida at production, and all of its Approximately 89 percent of Florida 621,373; the decline is largely grapefruit production. citrus production is produced for the attributable to hurricanes, diseases, and Total and domestic shipments of juice market, which is not regulated by urban development. With removals of Florida fresh citrus demonstrated a

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discernible improvement during the market from groves previously domestic market prior to 2004 was 2006–07 seasons with shipments prohibited from shipping interstate due approximately 34.1 million 4⁄5-bushel increasing by 26 percent and 7 percent, to citrus canker. Over the last decade, cartons each season compared to an respectively, over the previous season. the proportions of Florida fresh citrus average of 20.8 million 4⁄5-bushel Total and domestic shipments of Florida shipped within Florida, to other States, cartons over the last three seasons. fresh citrus remained virtually and internationally have remained fairly The Florida Citrus Packers, a unchanged during the 2005–06 season constant. Based on historical data from nonprofit cooperative association, over the previous season, showing few 1997–98 to 2006–07, an average of 10 commented during the public comment signs of recovery from the dramatic percent of Florida’s commercially period that the spread of citrus canker decline between the 2003–04 and 2004– packed fresh citrus was shipped had resulted in an estimated additional 05 seasons, when total and domestic intrastate (within Florida) each season, 20 percent of total fresh citrus groves in shipments declined by 42 percent and 52 percent was shipped to other States Florida declared ineligible for interstate 29 percent, respectively. Florida total each season, and 39 percent was shipment under the regulations in place and domestic fresh citrus shipments are exported to other countries each season. before this final rule because of the 30 percent and 24 percent less, The average proportion of Florida presence of citrus canker. The respectively, than they were prior to the fresh citrus shipments to the domestic commenter did not report a baseline for 2004–05 season. While fresh grapefruit market (intrastate and interstate) over this ‘‘additional 20 percent.’’ The continues to have the largest share of the last decade was approximately 61 Florida Citrus Packers further estimated total shipments of fresh Florida citrus percent of total shipments. The average that the fresh citrus fruit produced in including exports, oranges still account deviation in the proportion of fruit these groves represents approximately 8 for the State’s largest share of domestic shipped to the domestic market was million cartons of potential business shipments. During the 2006–07 season, approximately 3 percent (or opportunity under the revised Florida domestic shipments marginally approximately 982,000 4⁄5-bushel regulations. Based on the commenter’s increased to most geographical U.S. cartons).8 The proportion of Florida estimation of an additional 20 percent of regions, with the noted exception of a 4 fresh citrus shipments to the domestic Florida’s fresh citrus groves regaining percent decline in shipments to the market over the last 5 seasons was interstate shipment eligibility under this western U.S. region, which was chiefly approximately 62 percent of total final rule, and given historic attributable to the loss of market access shipments, with an average deviation of distribution patterns, we project as an to other citrus-producing States. approximately 5 percent (or roughly 1.2 upper bound that the shipment of fresh million 4⁄5-bushel cartons). citrus to States other than commercial Expected Costs and Benefits Citrus production in Florida has been citrus-producing States is likely to be The changes in the regulations in decline in recent years due in part to closer to 4.3 million 4⁄5-bushel cartons described in this document are likely to declining citrus tree inventories and per season. However, based on the primarily affect citrus producers and harsh weather conditions. Although the preceding discussion of the small packinghouses in Florida whose total quantity of Florida fresh citrus variability in the proportion of fruit operations rely on the interstate shipped has declined in recent years, shipped to various markets, it is not shipment of fresh citrus. The changes the allocation between the various likely that interstate shipments will will also affect the way resources are markets (e.g. interstate, intrastate, and increase by this projected upper bound. allocated for citrus canker mitigation export) has remained fairly consistent We also note that a portion of fruit from activities at both Federal and State despite this downward trend in these groves is expected to fail to meet levels. production. The proportion of Florida quality standards for the fresh market fresh citrus shipments to the domestic Effects on Florida Fresh Citrus and will be diverted to other channels, market prior to the 2004 hurricane Shipments including the processed market. This season was approximately 60 percent of issue is discussed in more detail earlier We expect the final rule to have little total shipments, with an average in this document under the heading economic effect on the production of deviation of approximately 2 percent (or ‘‘Comments on the Preliminary fresh citrus in Florida, but the shift from approximately 663,000 4⁄5-bushel Regulatory Impact Analysis and Initial inspection for citrus canker in the citrus cartons each season). Regulatory Flexibility Analysis.’’ groves, tree by tree, to the inspection of The proportion of Florida fresh citrus In addition, while any benefits to fresh citrus samples at the packinghouse shipments to the domestic market for Florida growers and packers are will likely result in increased shipments the past three seasons was expected to be small in the short term, of fresh citrus to States other than approximately 65 percent of total the RMA indicates that it will be very commercial citrus-producing States. As shipments, with an average deviation of hard to certify citrus groves as canker- such, the marketing effects of increased approximately 4 percent (or free in Florida in the future. In the long quantities of fresh citrus fruit on the approximately 841,000 4⁄5-bushel run, this rule is expected to provide domestic market may include changes cartons each season) The increased increased benefits in comparison to the in fresh market prices, processed market variability in the proportion of Florida regulations in place before the prices, and increased competition. fresh citrus shipped to the domestic publication of this final rule, while Under this final rule, Florida citrus is market over the last three seasons is continuing to prevent the interstate still prohibited from distribution to reflective of an industry recovering in spread of citrus canker. other commercial citrus-producing the wake of the 2004 and 2005 States. hurricane seasons. The average quantity Effects on Consumers APHIS expects the quantities of fresh of Florida fresh citrus shipped on the Consumers in States other than citrus shipped interstate from Florida to commercial citrus-producing States will reflect historic demand for Florida fresh 8 The average deviation is a measure of benefit from any increases in shipments citrus. We do not expect that interstate variability. It is computed for a series of data points of Florida fresh citrus. The increase in by finding the absolute difference between each shipments of fresh citrus will increase point and the average (mean) for the series, interstate shipments may lead to lower by a proportion equivalent to the summing these differences, and dividing by the prices, depending on the magnitude of potential production for the fresh total number of data points. the change and the price elasticity of

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demand. If the regulations in place Effects on Florida Packinghouses and Standards in the Agricultural Marketing before the publication of this final rule Citrus Growers Service’s regulations in 7 CFR part 51, had been maintained, Florida fresh In terms of operational adjustments, growers already employ the practice of citrus shipments to the domestic market Florida packinghouses are the segment surveying for fresh citrus fruit that are would have been expected to decline, of likely to be the not considered of fresh market quality. because the number of groves eligible most affected by the change in The high cost of inputs and production for certification as free of citrus canker regulations since the focus of the new practices employed in producing citrus would decline as a result of the spread protocol for treatments and APHIS fruit intended for the fresh market of citrus canker. In the long run, under inspections will be shifted away from yields a relatively low return to citrus this final rule, these consumers will the citrus groves to the packinghouse growers if the fruit is diverted to the benefit from a sustained supply of facilities. The final rule will require processed market because it is Florida fresh citrus. citrus packinghouses that move determined to be unsuitable for the regulated citrus fruit interstate to fresh market. Production costs In the short run, consumers within operate under an APHIS compliance associated with citrus fruit intended for Florida may experience increased agreement wherein the packinghouse the processed market are less than costs supplies associated with rejected lots operator agrees to meet all requirements associated with citrus fruit produced for that have been diverted intrastate. of the regulations. The provisions in the fresh market because the physical Florida consumers may benefit from § 301.75–7 pertaining to the inspection appearance of the fruit produced for the near-term price declines, again, of groves for citrus canker as a processed market is not important; depending on the quantities diverted to prerequisite for the interstate movement consequently, the value of citrus on the the fresh market within Florida and the of citrus are being removed. processed market is relatively low price elasticity of demand. However, in Citrus producers, however, will still compared to the value of citrus sold on the long run, any increase in intrastate retain the same incentives that currently the fresh market. In the long run, citrus shipments is expected to be less than exist to employ best management growers will maintain self-surveys and would occur under the regulations that practices when producing citrus for the best management practices as long as had been in place before the publication fresh market. A packinghouse charge to the costs of these practices are less than of this final rule. Under those the grower for citrus that does not meet the elimination charges and the price regulations, the number of groves the quality requirements is known as an discount that is incurred when their eligible for certification as free of citrus elimination charge, and is an existing fruit diverted from the fresh to the canker would have declined, along with industry measure for ensuring high processed market. Table 2 outlines the the quantity of fresh citrus approved for quality, symptom-free fruit. With average packinghouse charges for interstate movement. quality standards in place for fresh Florida fresh citrus during the 2005–06 citrus, as outlined as part of the U.S. season.

TABLE 2.—ESTIMATED AVERAGE TOTAL PACKING CHARGES PAID BY GROWERS, AND ELIMINATION CHARGES PAID BY GROWERS FOR LOTS THAT DO NOT MEET QUALITY REQUIREMENTS, 2005–06 a

Domestic Export Temples/ grapefruit grapefruit Oranges tangelos Tangerines

$/Carton c

Total packing charge b ...... $4.016 $4.395 $4.347 $4.614 $5.469

$/Box c

Drenching charge...... 0.181 0.189 0.181 0.184 0.188 Packinghouse elimination charges ...... 0.545 0.553 0.548 0.548 0.552 Hauling charges for eliminations ...... 0.505 0.534 0.515 0.531 0.534 Source: Ronald P. Muraro, University of Florida-Institute of Food and Agricultural Sciences, Citrus Research and Education Center, Lake Al- fred, FL, August 2006. a These packing charges are based on charges at four citrus packinghouses in the Interior production region and 13 citrus packinghouses in the Indian River production region. b Total packing charge refers to the charge to the grower for packed fruit, and is based upon packinghouse operational costs. Total packing charges are discussed in detail in the report ‘‘Average Packinghouse Charges for Florida Fresh Citrus—2005–06 Season,’’ (http:// edis.ifas.ufl.edu). c One box is equivalent to two 4⁄5-bushel cartons.

Focusing regulatory enforcement in growers seeking to minimize fruit is free from visible canker lesions. the packinghouse via required elimination charges and price discounts Packinghouses are responsible for all treatments and inspection of fruit have incentives to ensure that only fruit other quality inspections.) Minimizing intended for interstate movement is free of visible canker lesions enter a the charges back to the grower expected to be a more economically packing facility. Packinghouse associated the drenching, elimination, efficient means of ensuring a high level operations with fully integrated groves and hauling of fruit unsuitable for the of confidence that even a small also seek to minimize the costs fresh market through the practice of percentage of infected fruit will be associated with fruit rejected due to low grove surveys is commonly employed detected than the system in place before quality in general, especially since these by growers as part of their operations. the publication of this final rule. Both operations have more control over Tree inspections, which were packinghouses operating under production practices. (The purpose of previously conducted by APHIS and the compliance agreements with APHIS and the APHIS inspection is to ensure that Florida Department of Agriculture and

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Consumer Services (FDACS), will, we inspection of 1,000 pieces of fruit will (As stated earlier in this document, we believe, be conducted as self-surveys by take approximately 1 hour and 23 intend to provide for sampling of fruit the industry. Given the possibility of minutes (approximately 5 seconds per before it is packed into boxes in our elimination charges and price discounts, fruit). If the lot takes longer than that to compliance agreements with gift growers will apply the additional run, the inspection is not expected to packing operations.) resources needed to conduct these self- result in a delay. However, a base Effects on Public Sector Resources surveys as long as the benefits outweigh inspection level of 1,000 pieces of fruit the costs. may delay a lot that would require less According to APHIS, 10 additional The inspection process will be largely time than 1 hour and 23 minutes to run inspectors will be needed to implement dependent on the physical layout of the line. Packing would essentially have the final rule at a cost of $450,000 per each particular packinghouse. to halt while the inspection is year. The added cost for increased Conditions that must be met in order for completed before the next lot can be inspection at the packinghouse is APHIS inspectors to successfully run. In addition, if an inspector finds a expected to be offset by a reduction in conduct the required inspections would suspect lesion on a piece of fruit and the certain operational expenses in other translate into additional costs to the packer does not wish to immediately program areas. For example, pre-harvest packinghouse. Inspections will either divert to an alternative market (such as grove surveys will be reduced to only occur at the roll board prior to the fruit the intrastate or foreign market), the those required for phytosanitary being packed or after the fruit is packed. movement of that lot will be delayed certification to certain countries. The In either case, adequate lighting will be while APHIS makes a final FDACS anticipates a reduction in field a necessary component for the fruit determination on whether the lesion is staff by 65 percent from 340 to 120 field inspection process. If the inspection a citrus canker lesion. staff members, for a cost savings of occurs after fruit is packed, the The time it takes to run a lot of fruit approximately $38,000 per inspector (or packinghouse will be required to varies by packinghouse, and is $8.4 million). Florida appropriates provide a table and personnel to repack determined by numerous factors. It is funds to the FDACS from the Citrus the boxes after inspection. The APHIS reasonable to assume that an average Inspection Trust Fund to pay the costs inspection process will be designed time to run a lot of fruit is about 3 hours. associated with the salary and benefits with every effort to maintain the On the average, then, the inspection of of employees of the Bureau of Citrus efficiency of the packinghouse 9 1,000 pieces of fruit will not result in Inspection. operation. delays. If a packinghouse has its own The State of Florida allocated If a lot is rejected due to citrus canker approximately $10 million in funds detection, the lot will not be approved groves and packs its own fruit, lot sizes are generally larger, and no delays from the Agricultural Emergency for interstate movement. Alternative Eradication Trust Fund to the Citrus markets for this fruit are the intrastate should be expected. Packinghouses that do not pack their own fruit tend to run Health Plan line item for the 2007–08 market, some international markets, or fiscal year to be utilized for grove the processed market. The grower or multiple smaller lots whose identity must be maintained to ensure proper inspections (generally pre-harvest packinghouse will divert the fruit to the surveys), regulatory oversight, and market that yields the maximum return. payment to the respective growers. These packinghouses are more likely to nursery surveys. Approximately $11.3 Assuming the fruit is diverted to the million in funds from the Agricultural intrastate or an international market, the experience delays caused by the inspection of 1,000 pieces of fruit. Emergency Eradication Trust Fund were grower may incur repacking charges allocated to the Citrus Canker associated with fruit that was packed The treatment of fruit with a surface disinfectant, as reflected in the Eradication line item the previous fiscal before the lot was rejected in boxes or year, thus reducing emergency other containers approved only for drenching charges in table 1, occurs eradication program activities by interstate movement. These charges will under the existing regulations and is approximately $1.3 million and likely be in addition to drenching and conducted as a standard practice to allowing for the management of other elimination charges. Since the average extend shelf life. It also is a requirement citrus diseases and pests. Trust funds price that growers receive on the in the FDACS/Division of Plant Industry may be made available upon processed market is less than prices (DPI) compliance agreement with certification by the Commissioner that received on the fresh market, growers packers. Therefore, there is no an agricultural emergency exists and will likely suffer a loss by diverting additional cost associated with the that funds specifically appropriated for rejected lots to the processed market. change in regulations. the emergency’s purpose are exhausted Growers are more likely to maximize The APHIS compliance agreements or insufficient to eliminate the returns by diverting the fruit to available are not expected to present an entirely agricultural emergency.10 fresh markets, either intrastate or new situation for the packinghouses. The final rule will ensure resource international, depending on demand, Current compliance agreements with the savings associated with inspectors and even though they will likely incur State of Florida issued by the FDACS/ equipment for the State of Florida of repacking charges into cartons approved DPI are required of all packinghouses approximately $9.7 million per annum. for intrastate or international movement. that ship fresh citrus interstate. They Lot size is determined by the require the packinghouses to adhere to Concluding Statement on Benefits and packinghouse, and varies according to inspection requirements prior to the Costs the size of the packinghouse, the movement of fresh citrus. According to number of packing lines per facility, and Before the publication of this final section III.A of the FDACS rule, the regulations for the interstate the varieties of fresh citrus packed. packinghouse compliance agreement: Additionally, packinghouses generally movement for regulated fruit from Inspection of fruit for citrus canker lesions quarantined areas placed several identify each lot run through the will take place during the washing/grading packinghouse with a lot number that process, and a designated number of packed 9 Title XXXV Section 601.28 of the Florida can be traced back to the origin of the boxes will be required to be pulled, opened Statutes. lot. APHIS field personnel estimate that and made available for inspection by Federal 10 Title XXXV Section 570.191 of the Florida under ideal circumstances, the or State regulatory officials. Statutes.

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restrictions on the interstate movement prohibited from sending to the Summary of Significant Issues Raised of citrus fruit from Florida, including packinghouses for interstate shipment During Comment Period on the Initial inspections of citrus groves to ensure fruit from citrus groves in which citrus Regulatory Flexibility Analysis that they are free of citrus canker, pre- canker has been detected. As long as a There were no significant issues harvest inspections, treatments, and lot of citrus fruit is found to be raised in public comment on the initial movement under limited permit. symptom-free upon APHIS inspection, regulatory flexibility analysis (IRFA) for The new regulations replace the the lot will be eligible for shipment to this rulemaking. One commenter from existing protocol for the movement of States other than commercial citrus- California, however, expressed concerns citrus fruit from citrus canker producing States. Growers with citrus that the impact of citrus canker on the quarantined areas. A packinghouse that groves in which citrus canker has been production costs in other citrus- ships fresh citrus interstate is required detected will have an additional producing States would be devastating to operate under an APHIS compliance marketing option for their fruit. should the disease spread as a result of agreement wherein the packinghouse Consumers on the domestic market may this rule. The commenter further operator agrees to meet the requirements benefit from increased market quantities defined these costs as the costs involved of the regulations. APHIS inspections of and lower prices of fresh citrus if a with copper sprays, isolation fencing, fresh citrus will occur at the greater market demand exists than is and spraying for disinfection. The packinghouse level. This final rule also met by the current supply. We expect commenter went on to declare that specifies treatment requirements for all that Florida packinghouses that wish to monitoring and surveying would be commercially packed fresh citrus. The ship interstate will continue to do so as very expensive given the high cost of required treatment, however, is already long as the financial benefits to them of labor. The majority of citrus producers performed at the 50 largest commercial operating under these provisions exceed in California would be considered small packinghouses, as well as at any smaller their costs. entities according to the Small Business packinghouses that pack fruit for Finally, the costs to the public sector Administration (SBA) guidelines. interstate movement under the We have addressed this comment associated with the final regulations are regulations in place before the earlier in this document under the expected to be marginal in comparison publication of this final rule. We believe heading ‘‘Comments on the Preliminary packinghouses will adjust to the new to the benefits of a more efficient system Regulatory Impact Analysis and Initial regulations with little to no economic for fresh citrus fruit movement. Regulatory Flexibility Analysis.’’ hardship in the long run. Packinghouses Final Regulatory Flexibility Analysis currently face similar regulations as Description and Estimated Number of required by the Florida compliance The Regulatory Flexibility Act Small Entities Regulated agreements for packinghouses. Although requires that agencies consider the Florida’s citrus packinghouses and the final rule adds a definition of economic impact of rule changes on fresh citrus producers comprise the commercial packinghouse for the small businesses, organizations, and industries that we expect to be directly purposes of implementing the rule, all governmental jurisdictions. Section 604 affected by the final rule. The small currently operating Florida of the Act requires agencies to prepare business size standards for citrus fruit packinghouses qualify as commercial and make available to the public a final packing, as identified by the SBA based packinghouses under this definition; regulatory flexibility analysis (FRFA) upon the North American Industry APHIS thus does not anticipate that describing any changes made to the rule Classification System (NAICS) code commercial citrus packinghouses will as a result of comments received and the 115114 (Postharvest Crop Activities), is incur any costs as a result of adding this steps the agency has taken to minimize $6.5 million or less in annual receipts. new definition. any significant economic impacts on According to the County Business Packinghouse charges to growers for small entities. Section 604(a) of the Act Patterns report for Florida published by eliminations and price discounts for specifies the content of a FRFA. In this the U.S. Census Bureau, there were 71 fruit diverted from the fresh to the section, we address these FRFA post-harvest operations in Florida in processed market are incentives to requirements. 2004. Although this publication reports growers to ensure fruit sent to the the number of employees, the number of packinghouse for packing is free of Need for and Objective of the Rule firms by employment size and the symptoms of citrus canker. Growers will annual payroll for firms included in self-survey groves as long as the benefits Based on our evaluation of production NAICS 115114, it does not report the outweigh the cost of the procedure. The and processing procedures and their distribution of annual sales for firms in provisions will provide the added impact on removal of citrus canker from this category. Neither is information on benefit to growers of being able to ship the fresh fruit pathway, along with our annual sales published in the Census of symptom-free fresh citrus from groves review of the operational feasibility of Agriculture or the Economic Census. previously prohibited from interstate enforcing various mitigation measures, There are at least 142 packinghouses APHIS has concluded that the movement due to the presence of citrus currently registered in Florida.11 While mandatory packinghouse inspection of canker in the grove. the classification of these processed fruit provides an effective The final rule will also provide establishments by sales volume is not safeguard to prevent the spread of citrus opportunities for commercial available, it is estimated that canker via the movement of commercial packinghouses to treat and pack approximately 50 of the 142 registered citrus fruit. Since regulations that were interstate shipments of dooryard commercial packinghouses are large in place before the publication of this plantings of citrus fruit. Such shipments citrus packinghouses with the final rule required groves to be free of will also be inspected by APHIS. remainder being small establishments, Benefits of this final rule may include citrus canker in order for fruit to be many known as gift packers, in Florida. the possibility of gains from a larger eligible for interstate movement, the The Fresh Shippers Report, as reported volume of Florida shipments to changes in this final rule are necessary consumers in States other than in order for the packinghouse-based 11 Florida Department of Agriculture and commercial citrus-producing States. treatment and inspection protocol to be Consumer Services, Division of Fruit & Vegetable Producers would no longer be implemented. Inspection. http://www.doacs.state.fl.us/fruits.

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by the Citrus Administrative Committee, the farm categories Orange Groves National Environmental Policy Act details quantities of fresh citrus (NAICS 111310) and Citrus (except An environmental assessment and shipments of the top 40 to 50 shippers Orange) Groves (NAICS 111320). SBA finding of no significant impact have 12 of each season. At least 98 percent of classifies producers in these categories been prepared for this final rule. The Florida fresh citrus shipments are with total annual sales of not more than environmental assessment provides a packed through the top 40 to 50 $750,000 as small entities. According to basis for the conclusion that the 13 packinghouses in the State. During the 2002 Census data, there were a total of interstate movement of citrus fruit 2005–06 citrus season, annual sales for 7,653 citrus farms in Florida in 2002. Of under the conditions specified in this 21 of the top 40 shippers (52.5 percent) this number, approximately 94 percent rule will not have a significant impact were below the SBA size standard of had annual sales in 2002 of less than on the quality of the human $6.5 million. It is estimated that at least $500,000, which is well below the environment. Based on the finding of no 85 percent of citrus packers, including SBA’s small entity threshold of significant impact, the Administrator of 14 small gift packers, are considered small $750,000. While it is likely this final the Animal and Plant Health Inspection according to the SBA size standards. rule will result in higher packinghouse Service has determined that an The final rule will implement a new charges to the grower, costs associated environmental impact statement need protocol for inspections and treatments with the final rule are expected to be not be prepared. that will likely result in additional costs minimal. Citrus growers previously The environmental assessment and to packinghouses. Examples of prohibited from interstate shipment of finding of no significant impact were additional costs include providing fresh citrus due to citrus canker prepared in accordance with: (1) The adequate lighting and space for fruit detection in their groves will have an National Environmental Policy Act of inspection and labor to repack boxes additional marketing opportunity for 1969 (NEPA), as amended (42 U.S.C. which have been unpacked during their fruit provided the fruit meets the 4321 et seq.), (2) regulations of the inspection. Essentially, the inspection requirements to pass APHIS inspection. Council on Environmental Quality for and treatment process is an additional Description and Estimate of Compliance implementing the procedural provisions quality control measure. In the short Requirements of NEPA (40 CFR parts 1500–1508), (3) run, it is likely that commercial USDA regulations implementing NEPA Florida’s packinghouses that ship packinghouses will increase packing (7 CFR part 1b), and (4) APHIS’ NEPA fresh citrus interstate would be subject charges to cover any additional costs Implementing Procedures (7 CFR part to compliance agreements with APHIS, associated with the final rule, passing 372). as described in section IV of the full some of the cost of the rule onto the The environmental assessment and final regulatory impact analysis. growers. However, packinghouse finding of no significant impact may be average costs may rise with the Description of Steps Taken To Minimize viewed on the Regulations.gov Web imposition of this quality control Significant Economic Impacts on Small site.15 Copies of the environmental measure due to increases in the average Entities assessment and finding of no significant variable costs associated with APHIS does not believe small entities impact are also available for public maintaining a consistent level of output. inspection at USDA, Room 1141, South Examples of expected increases in will suffer significant economic losses as a result of this final rule. APHIS Building, 14th Street and Independence average variable costs include higher Avenue, SW., Washington, DC, between labor costs associated with repacking of intends to devise a compliance agreement that is suitable for both large 8 a.m. and 4:30 p.m., Monday through 4/5-bushel cartons or an inspection Friday, except holidays. Persons process that slows or shuts down the and small commercial packinghouses, especially with respect to the inspection wishing to inspect copies are requested packing line for any period of time. The to call ahead on (202) 690–2817 to inspection process will add one more process. Citrus growers will continue to have the same incentives to employ best facilitate entry into the reading room. In layer to the production process. As the addition, copies may be obtained by base level for inspection increases, so management practices that will yield citrus fruit meeting the quality writing to the individual listed under does inspection time. Therefore, as FOR FURTHER INFORMATION CONTACT. inspection sample size increases, the standards required at the packinghouse. efficiency and productivity of the Executive Order 12372 Paperwork Reduction Act packinghouse, especially the smaller This program/activity is listed in the In accordance with the Paperwork packinghouses and gift packers, could Catalog of Federal Domestic Assistance Reduction Act of 1995 (44 U.S.C. 3501 become hindered. Overall, the industry under No. 10.025 and is subject to et seq.), the information collection or will benefit; inspection for citrus canker Executive Order 12372, which requires recordkeeping requirements included in lesions at the packinghouse will intergovernmental consultation with this rule have been approved by the maintain sales to interstate markets State and local officials. (See 7 CFR part Office of Management and Budget more efficiently than would be possible 3015, subpart V.) (OMB) under OMB control number under the current grove inspections. 0579–0325. The final rule will also affect Executive Order 12988 E-Government Act Compliance producers of fresh citrus in Florida. This final rule has been reviewed Most, if not all, of the Florida citrus under Executive Order 12988, Civil The Animal and Plant Health producers that will be affected by the Justice Reform. This rule: (1) Preempts Inspection Service is committed to final rule are small, based on 2002 all State and local laws and regulations compliance with the E-Government Act Census of Agriculture data and SBA that are inconsistent with this rule; (2) to promote the use of the Internet and guidelines for entities classified within has no retroactive effect; and (3) does other information technologies, to not require administrative proceedings 12 ‘‘Fresh Shippers Report: 2005–06 Season before parties may file suit in court 15 Go to http://www.regulations.gov/fdmspublic/ Through July 31, 2006,’’ Citrus Administrative component/main?main=DocketDetail&d=APHIS- Committee, August 18, 2006. http://www.citrus challenging this rule. 2007-0022. The environmental assessment and administrativecommittee.org/. finding of no significant impact will appear in the 13 Ibid. 14 Source: SBA and 2002 Census of Agriculture. resulting list of documents.

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provide increased opportunities for various surfaces and chemical control of I a. In the definitions for ‘‘certificate’’ citizen access to Government Asiatic citrus canker (ACC). International and ‘‘limited permit’’, by adding the information and services, and for other Citrus Canker Research Workshop, Ft. Pierce, words ‘‘stamp, form, or other’’ after the purposes. For information pertinent to FL. words ‘‘An official’’. Koizumi, M. (1972). ‘‘Studies on the I b. By adding new definitions of E-Government Act compliance related symptoms of citrus canker formed on to this rule, please contact Mrs. Celeste Satsuma mandarin fruit and existence of ‘‘commercial packinghouse’’ and ‘‘lot’’ Sickles, APHIS’ Information Collection causal bacteria in the affected tissues.’’ Bull. to read as set forth below. Coordinator, at (301) 734–7477. Hort. Res. Sta., Japan, Ser. B 12: 229–244. § 301.75–1 Definitions. Peltier, G.L. and W.J. Frederich (1926). References ‘‘Effects of weather on the world distribution * * * * * Belasque, J. and J. Rodriguez Neto (2000). and prevalence of citrus canker and citrus Commercial packinghouse. An ‘‘Survival of the citrus canker bacterium in scab.’’ Journal of Agricultural Research 32(2): establishment in which space and non-infected orange fruits.’’ Summa 147–164. equipment are maintained for the Phytopathologica 26(1): 128 (Resumo 153). Riley, T. (2007). E-mail dated 1/24/2007 primary purpose of packing citrus fruit Borchert, D., C. Thayer, L. Brown, N. Jones from T. Riley, Lead Plant Pathologist, APHIS for commercial sale. A commercial and R. Magarey (2007). Citrus Canker Ad Hoc Citrus Health Response Program to L.M. packinghouse must be registered as a Project, USDA–APHIS–PPQ–CPHST–PERAL Ferguson Re: Citrus Canker lesion sizes/Xac (internal document). viability. packinghouse with the State in which it Brown, G.E. and T.S. Schubert (1987). ‘‘Use Timmer, L.W., S.E. Zitko and T.R. operates or hold a business license for of Xanthomonas campestris pv. vesicatoria Gottwald (1996). ‘‘Population dynamics of treating and packing fruit. to evaluate surface disinfectants for canker Xanthomonas campestris pv. citri on * * * * * quarantine treatment of citrus fruit.’’ Plant symptomatic and asymptomatic citrus leaves Lot. The inspectional unit for fruit Disease 71(4): 319–323. under various environmental conditions.’’ composed of a single variety of fruit that Canteros, B. I. (undated). Effect of low Proceedings of the International Society of has passed through the entire packing concentrations of sodium hypochlorite in Citriculture 1: 448–451. process in a single continuous run not external disinfection of organic fruits as USDA–National Agricultural Statistics quarantine treatment for citrus canker. INTA Service (2007). Commercial Citrus Inventory to exceed a single workday (i.e., a run Final Report. 2006. Prepared with Florida Department of started one day and completed the next CRARM (Presidential/Congressional Agriculture and Consumer Services. is considered two lots). Commission on Risk Assessment and Risk Verdier, E., E. Zefferino and S. Mendez * * * * * Management). 1997a. Framework for (2006). ‘‘Xanthomonas axonopodis pv. citri I 3. Section 301.75–7 is amended as Environmental Health Risk Assessment, survival in Citrus fruit submitted to post follows: Final Report, Volume 1. Washington, DC: harvest treatment using detecting by semi- I The Presidential/Congressional Commission a. Paragraphs (a)(1), (a)(2), (a)(5), and selective culture media and bioassay.’’ (a)(6) are revised to read as set forth on Risk Assessment and Risk Management. Unpublished (submitted with public CRARM (Presidential/Congressional comments to 2006 citrus canker interim rule). below. I Commission on Risk Assessment and Risk Verniere, C.J., T.R. Gottwald and O. b. An OMB citation is added at the Management). 1997b. Risk Assessment and Pruvost (2003). ‘‘Disease development and end of the section to read as set forth Risk Management in Regulatory symptom expression of Xanthomonas below. Decisionmaking, Final Report, Volume 2. axonopodis pv. citri in various citrus plant Washington, DC: The Presidential/ tissues.’’ Phytopathology 93: 832–843. § 301.75–7 Interstate movement of Congressional Commission on Risk regulated fruit from a quarantined area. Assessment and Risk Management. List of Subjects (a) * * * Dalla Pria, M., R.C.S. Christiano, E.L. 7 CFR Part 301 (1) Every lot of regulated fruit to be Furtado, L. Amorim and A. Bergamin Filho moved interstate must be inspected by (2006). ‘‘Effect of temperature and leaf Agricultural commodities, Plant an APHIS employee at a commercial wetness duration on infection of sweet diseases and pests, Quarantine, oranges by Asiatic citrus canker.’’ Plant packinghouse for symptoms of citrus Reporting and recordkeeping canker. Any lot found to contain fruit Pathology 55: 657–663. requirements, Transportation. Fulton, H.R. and J.J. Bowman (1929). with visible symptoms of citrus canker ‘‘Infection of fruits by Pseudomonas citri.’’ J. 7 CFR Part 305 will be ineligible for interstate Agric. Res. 39: 403–426. movement from the quarantined area. Golmohammadi, M., J. Cubero, J. Pen˜ alver, Irradiation, Phytosanitary treatment, The number of fruit to be inspected will J.M. Quesada, M.M. Lopez, and P. Llop Plant diseases and pests, Quarantine, be the quantity that is sufficient to (2007). ‘‘Diagnosis of Xanthomonas Reporting and recordkeeping detect, with a 95 percent level of axonopodis pv. citri, causal agent of citrus requirements. confidence, any lot of fruit containing canker, in commercial fruits by isolation and I Accordingly, we are amending 7 CFR PCR-based methods.’’ Journal of Applied 0.38 percent or more fruit with visible 1 Microbiology ISSN 1364–5072. parts 301 and 305 as follows: canker lesions. Gottwald, Timothy. Report of lecture given (2) The owner or operator of any on Citrus Packinghouse Day at Citrus PART 301—DOMESTIC QUARANTINE commercial packinghouse that wishes to Research and Education Center. Cited in NOTICES move citrus fruit interstate from the www.theledger.com. 08/19/06. I 1. The authority citation for part 301 quarantined area must enter into a Gottwald, T.R. and J.H. Graham (1992). ‘‘A continues to read as follows: compliance agreement with APHIS in device for precise and nondisruptive accordance with § 301.75–13. stomatal inoculation of leaf tissue with Authority: 7 U.S.C. 7701–7772 and 7781– bacterial pathogens.’’ Phytopathology 82: 7786; 7 CFR 2.22, 2.80, and 371.3. * * * * * 930–935. Section 301.75–15 issued under Sec. 204, Graham, J.H., T.R. Gottwald, T.D. Riley and Title II, Public Law 106–113, 113 Stat. 1 If conditions warrant changing the number of M.A. Bruce (1992b). ‘‘Susceptibility of citrus 1501A–293; sections 301.75–15 and 301.75– fruit to a quantity that gives a statistically fruit to bacterial spot and citrus canker.’’ significant level of confidence of detecting lots 16 issued under Sec. 203, Title II, Public Law containing a different percentage, determined by Phytopathology 82(4): 452–457. 106–224, 114 Stat. 400 (7 U.S.C. 1421 note). the Administrator, of fruit with visible canker Graham, J.H., T.R. Gottwald, T.D. Riley, J. lesions, APHIS will provide for public participation I Cubero and D.L. Drouillard (2000). Survival 2. Section 301.75–1 is amended as in that process through the publication of a notice of Xanthomonas campestris pv. citri (Xcc) on follows: in the Federal Register.

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(5)(i) Each lot of regulated fruit found or boxes that are marked with this (3) Peroxyacetic acid. The regulated to be eligible for interstate movement statement. fruit must be thoroughly wetted for at must be accompanied by a limited (6) A lot of fruit that is determined to least 1 minute with a solution permit issued in accordance with be ineligible for interstate movement containing 85 parts per million § 301.75–12. Regulated fruit to be under paragraph (a)(1) of this section peroxyacetic acid. moved interstate must be packaged in may not be reconditioned and submitted * * * * * for reinspection. boxes or other containers that are (d) * * * approved by APHIS and that are used * * * * * exclusively for regulated fruit that is (Approved by the Office of Management and (5) A solution containing 85 parts per eligible for interstate movement. The Budget under control number 0579–0325) million peroxyacetic acid (indoor use boxes or other containers in which the I 4. Section 301.75–11 is amended as only). fruit is packaged, and any shipping follows: I PART 305—PHYTOSANITARY documents accompanying the boxes or a. In paragraph (a), by revising the TREATMENTS other containers, must be clearly introductory text to read as set forth marked with the statement ‘‘Limited below. I 5. The authority citation for part 305 Permit: USDA–APHIS–PPQ. Not for I b. By redesignating paragraph (a)(3) as continues to read as follows: distribution in AZ, CA, HI, LA, TX, and paragraph (a)(4) and adding a new American Samoa, Guam, Northern paragraph (a)(3) to read as set out below. Authority: 7 U.S.C. 7701–7772 and 7781– Mariana Islands, Puerto Rico, and Virgin I c. In newly redesignated paragraph 7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, Islands of the United States.’’ Only fruit (a)(4) by adding the words ‘‘, 2.80, and 371.3. that meets all of the requirements of this peroxyacetic acid,’’ after the word I 6. Section 305.11 is amended by section may be packed in boxes or other ‘‘hypochlorite’’. adding a new paragraph (c) to read as containers that are marked with this I d. In paragraph (d)(3), by removing the follows: statement; word ‘‘or’’. I e. In paragraph (d)(4), by removing the § 305.11 Miscellaneous chemical (ii) Provided, that until August 1, period at the end of the paragraph and treatments. 2008, fruit that meets all the adding the word ‘‘; or’’ in its place. * * * * * requirements of this section may be I f. By adding a new paragraph (d)(5) to (c) CC3 for citrus canker. The fruit packed in bags that are clearly marked read as set forth below. must be thoroughly wetted for at least with the statement ‘‘Not for distribution 1 minute with a solution containing 85 in AZ, CA, HI, LA, TX, and American § 301.75–11 Treatments. parts per million peroxyacetic acid. Samoa, Guam, Northern Mariana (a) Regulated fruit. Regulated fruit for Islands, Puerto Rico, and Virgin Islands which treatment is required by this Done in Washington, DC, this 14th day of of the United States,’’ as long as the bags subpart must be treated in at least one November 2007. of fruit are packed in boxes that are of the following ways at a commercial J. Burton Eller, marked as required by paragraph packinghouse whose owner operates Acting Under Secretary for Marketing and (a)(5)(i) of this section. Fruit that does under a compliance agreement under Regulatory Programs. not meet all the requirements of this § 301.75–7(a)(2): [FR Doc. E7–22549 Filed 11–16–07; 8:45 am] section may not be packed in either bags * * * * * BILLING CODE 3410–34–P

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