# Importation of Clementines From Spain > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A02-26668 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** October 21, 2002 - **Citation:** 67 FR 64702 ## Text DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 319 [Docket No. 02-023-4] RIN 0579-AB40 Importation of Clementines From Spain AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. SUMMARY: We are amending the fruits and vegetables regulations to allow the importation of clementines from Spain to resume if the clementines are cold treated en route to the United States, and provided that other pre-treatment and post-treatment requirements are met. These requirements include provisions that the clementines be grown in accordance with a Mediterranean fruit fly management program established by the Government of Spain, that the clementines be subject to an inspection regimen that includes fruit cutting prior to, and after, cold treatment, and that the clementines meet other conditions designed to protect against the introduction of the Mediterranean fruit fly into the United States. This final rule also includes restrictions on the distribution of imported Spanish clementines for the 2002-2003 shipping season. We are taking this action based on our finding that the restrictions described in this final rule will reduce the risk of introduction of Mediterranean fruit fly associated with the importation of clementines from Spain. EFFECTIVE DATE: October 15, 2002. FOR FURTHER INFORMATION CONTACT: Dr. I. Paul Gadh, Import Specialist, Phytosanitary Issues Management Team, PPQ, APHIS, 4700 River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-6799. SUPPLEMENTARY INFORMATION: Background The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56 through 319.56-8) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction or dissemination of plant pests, including fruit flies, that are new to or not widely distributed within the United States. Until recently, the Animal and Plant Health Inspection Service (APHIS) authorized the importation of clementines from Spain under the regulations in § 319.56-2(e)(2). As such, clementines from Spain were imported under permit, provided that they were cold treated for the Mediterranean fruit fly ( Ceratitis capitata ) (Medfly). Clementines imported from Spain were not required to meet any additional regulatory requirements in order to be imported into the United States, but were subject to inspection at the port of entry. Between November 20 and December 11, 2001, several live Medfly larvae were intercepted in clementines from Spain. On December 5, 2001, APHIS notified the Government of Spain that it was suspending the importation of clementines. Beginning December 5, 2001, all shipments of clementines from Spain were refused entry into the United States. APHIS also announced restrictions on the marketing of Spanish clementines that had already been released into domestic commerce. APHIS believes, based on the available evidence, that there are several possible explanations for the survival of Medfly larvae in imported Spanish clementines during the 2001-2002 shipping season. In order to address this problem, since December 5, 2001, APHIS has prohibited the importation of clementines from Spain while it considered alternate approaches to mitigating the Medfly risk posed by clementines from Spain. Revised Risk Mitigation for Spanish Clementines On April 16, 2002, we published in the Federal Register (67 FR 18578-18579, Docket No. 02-023-1) a notice of availability and request for comments on a risk management analysis, “Risk mitigation for Mediterranean fruit flies with special emphasis on risk reduction for commercial imports of clementines (several varieties of Citrus reticulata ) from Spain” (referred to elsewhere in this document as “risk management analysis” or “RMA”). The RMA describes and evaluates the use of certain risk-mitigating measures associated with the importation of clementines from Spain. We solicited comments on the RMA for 30 days ending May 16, 2002. On May 24, 2002, we published in the Federal Register (67 FR 36560-36561, Docket No. 02-023-2) a notice in which we reopened and extended the comment period for our risk management analysis until June 14, 2002. We received a total of 17 comments on the RMA by that date. We considered the comments and described changes made to the RMA in a revision dated July 5, 2002. On July 11, 2002, we published in the Federal Register (67 FR 45922-45933, Docket No. 02-023-3) a proposal to amend fruits and vegetables regulations to allow the importation of clementines from Spain to resume if the clementines are cold treated en route to the United States, and provided that other pre-treatment and post-treatment requirements are met. These requirements included provisions that the clementines be grown in accordance with a Medfly management program established by the Government of Spain, that the clementines be subject to an inspection regimen that includes fruit cutting prior to, and after, cold treatment, and that the clementines meet other conditions designed to protect against the introduction of the Medfly into the United States. We proposed this action based on our finding that the requirements described in the proposed rule would reduce the risk of introduction of Medfly and other plant pests associated with the importation of clementines from Spain. The proposed rule also provided notice of two public hearings related to our proposal and detailed the dates, times, and locations of those hearings. We solicited comments concerning our proposal for 60 days ending September 9, 2002. We received 33 comments by that date, in addition to testimony provided by 30 persons at the two public hearings. The comments were from officials of State departments of agriculture, officials of foreign Governments, Members of Congress, scientists, representatives of associations such as farm bureaus, marketing associations, consumer groups, and trade associations, and growers, packers, and shippers of fruits and vegetables. Twelve of the commenters supported the rule, and 40 opposed some aspect of it. Fifteen commenters noted that APHIS should ensure that its decision to proceed with a final rule is based on science, and at least 10 commenters stated that APHIS should delay action until additional information is available to eliminate uncertainty in its approach. The issues raised in the comments are discussed below, by topic. Determination by the Secretary In this document, APHIS is adopting its proposal to allow the importation of clementines from Spain to resume as a final rule, with the changes discussed in this document. Under § 412(a) of the Plant Protection Act, the Secretary of Agriculture may prohibit or restrict the importation and entry of any plant product if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. The Secretary has determined that it is not necessary to prohibit the importation of clementines from Spain in order to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. This determination is based on the finding that the application of the remedial measures contained in this final rule will prevent the introduction or dissemination of plant pests into the United States. The factors considered in arriving at this determination include: (1) A risk management analysis (revised October 4, 2002), (2) a review of the existing cold treatment for clementines from Spain, “Evaluation of cold storage treatment against Mediterranean Fruit Fly, Ceratitis capitata (Wiedemann) (Diptera: Tephritidae)” (May 2, 2002) (referred to elsewhere in this document as “cold treatment evaluation”), (3) a quantitative analysis of available data related to cold treatment for Medfly that was produced by USDA's Office of Risk Assessment and Cost Benefit Analysis (ORACBA), “Revised Quantitative Analysis of Available Data on the Efficacy of Cold Treatment Against Mediterranean Fruit Fly Larvae” (September 20, 2002), referred to elsewhere in this document as “ORACBA analysis,” and (4) the determinations of USDA technical experts. Discussion of Public Comments Clarification of Terms Several commenters expressed confusion over our use of the terms “shipment” and “lot.” We discuss this issue in more detail later in this document. In response to those commenters' requests for clarification, we have defined those terms. In our final rule, a lot of clementines is considered to include a number of units of clementines that are from a common origin ( i.e. , a single producer or a homogenous production unit). 1 The definition of the term shipment depends on the context in which it is used. Specifically, the definition depends on whether or not fruit has been treated. The term can refer to one or more lots of clementines that are presented to an APHIS inspector for pre-treatment inspection. Such a shipment may not include more than 200,000 boxes of clementines (555 pallets). The term can also refer to one or more lots of clementines that are imported into the United States on the same conveyance. Our use of these terms in the remainder of this document is consistent with these definitions. 1 A homogeneous production unit is a group of adjacent orchards in Spain that are owned by one or more growers who follow a homogenous production system under the same technical guidance. The fruit produced by these units is pooled and packed together, and all the orchards in the group are regulated as one unit in the event that traceback of infested fruit is necessary. General Comments Several commenters questioned whether Spain, in just 9 months, has taken the proper steps to ensure their product is free from Medfly, and asked what changes have taken place in Spain's production areas since the shutdown of their exports in December 2001. The system we have designed for the resumption of imports of Spanish clementines is designed to ensure that APHIS will be able to detect infestation levels of 1.5 percent or greater with a high (95 percent) level of confidence through the pre-treatment cutting of randomly selected fruit. 2 If a single live Medfly in any stage of development is detected during pre-treatment fruit cutting, the shipment of clementines in which the Medfly is found will not be approved for export to the United States. 2 We will also be able to detect lower levels of infestation in clementines with varying levels of confidence as described in detail under the heading, “Infestation Levels, Inspection, and Fruit Cutting.” Conversely, if no infested fruit are detected via fruit cutting, APHIS's analysis shows that the revised cold treatment will eliminate any undetected low-level Medfly infestations. Furthermore, fruit cutting at the port of entry is designed to provide additional assurance that the revised cold treatment was successful. For these reasons, APHIS believes the new Spanish clementine import program will prevent the introduction or dissemination of Medflies into the United States. Nonetheless, to further ensure that the program does not result in the introduction of Medflies into the United States, we have required Spanish growers, in order to be approved to export to the United States, to enter into the Government of Spain's Medfly management program, which APHIS must approve, and which must ensure low levels of infestation in clementine production areas. We believe the activities required under Spain's program, which include phytosanitary measures that must be followed in the field and at packinghouses, represent a significant improvement over Spain's efforts in 2001. Several commenters noted that APHIS still does not know “what went wrong” in 2001, when there were multiple live larvae finds on Spanish clementines in several different regions of the United States. The commenters suggested that designing a solution when the problem is not fully understood is risky. Specifically, one of those commenters proposed that despite APHIS's determination that there are two possible scenarios that could explain the discovery of live larvae in clementines imported from Spain, a third scenario, that both those things occurred, is also possible. APHIS acknowledges that the cause of last year's infestations of imported Spanish clementines has not been definitively established; however, we have responded as if the problem resulted from one or both of the following: (1) Despite the assumed mortality rate of the cold treatment (99.9968 percent), any small or partial failure in the application of the cold treatment could have allowed Medflies to survive in clementines imported from Spain due to the above-average levels of Medflies in the growing areas in Spain, or (2) the level of Medfly infestation in imported clementines simply overwhelmed the capabilities of the cold treatment process, even though the treatment was properly applied. These two scenarios have received support from State agricultural officials and domestic stakeholders. We believe the system we have designed addresses all possible explanations for the problem. In order to address the first explanation for last year's problem, APHIS has extended cold treatment as described in this document, and is confident that the prescribed cold treatment will provide a high level of mortality of target pests (equivalent to probit 9 mortality). The extension of cold treatment also addresses concerns that the cold treatment under the previous schedule may not have provided probit 9 mortality. 3 We have conducted a thorough review of the documentation of cold treatment application and have found no evidence that cold treatment was improperly applied during the 2001 shipping season, although a long-term thermal-mapping study on the application of cold treatment is underway. That study, which was initiated before the Medfly infestations of Spanish clementines occurred in 2001, is described in more detail later in this document under the heading “Cold Treatment.” 3 A level or percentage of mortality of target pests ( i.e., 99.9968 percent mortality or 32 survivors out of a million) caused by a control measure. Regarding the second explanation for the problem, we have required that levels of infestation of Spanish clementines presented for export be kept at low levels (levels that cannot be detected via fruit cutting) in order to ensure that high levels of infestation do not cause the treatment to be overwhelmed. Inspection and cutting of clementines prior to cold treatment will ensure that this requirement is met. One commenter noted that shortly after the interceptions of Medfly larvae in Spanish clementines, APHIS advised that the situation would be handled with transparency, stakeholder involvement, and most critically, that science would be the only determinant relative to developing a protocol and plan for the potential resumption of Spanish clementine shipments into the United States. The commenter stated that APHIS has failed to honor its commitment as a result of a predetermined decision to allow clementines back into the U.S. market for this upcoming season. APHIS has upheld its commitment to handle the issue of the importation of Spanish clementines with transparency and stakeholder involvement, and the Secretary has based her determination to allow the importation of clementines from Spain to resume on science, and in accordance with the requirements of the Administrative Procedure Act. We have made the documents that support this rule available for public comment, some for as long as 120 days. We have listened to stakeholder concerns in meetings and at public hearings. We have made changes to our supporting documents based on stakeholder review and comments. We have considered all comments received on our proposed rule and its supporting documents and have documented our responses in this final rule. For the reasons outlined in this document, our decision to allow the resumption of clementines from Spain is based on science. Two commenters claimed that APHIS's characterization of the events leading to the December 5, 2001, suspension of clementine imports from Spain is questionable. They stated that at no time has APHIS produced credible and verifiable evidence of live and viable Medfly larvae in shipments of Spanish clementines. APHIS takes quarantine action on imported commodities if a given commodity is found to be infested with a live quarantine pest, and APHIS's actions in December 2001 were based on repeated findings of live Medfly larvae in imported Spanish clementines. APHIS believes that it is often impossible and always impractical to determine the true viability of a live pest intercepted in an imported commodity, especially one that has undergone cold treatment. Therefore, APHIS has no other alternative but to take action to protect American agriculture based on the finding of a live pest in any stage of development. This course of action is consistent with our authority under the Plant Protection Act. Determining the true viability of Medflies would require APHIS to rear them to adults, allow them to mate, lay eggs, etc., all under high security conditions to protect against the escape of the pest to the natural environment. APHIS has no doubt, based on visual inspections by field and headquarters personnel, including expert identifiers, that the larvae were indeed alive upon interception in the United States. One commenter claimed that there has never been such a catastrophic failure of an APHIS program as there was with Spanish clementines in 2001, and APHIS has no idea what the results of that failure will be. The commenter questioned whether Medfly could be established somewhere in the United States as a result of 2001 imports of Medfly-infested Spanish clementines. APHIS believes that if clementines imported from Spain caused the establishment of Medfly in the mainland United States, that would indeed represent a catastrophic failure of the APHIS import program. However, APHIS has no evidence to indicate that infested Spanish clementines have resulted in a Medfly establishment in the United States. Despite the events of 2001, APHIS's actions to address the situation appear to have been successful. Since October 2001, the only wild Medfly detected in the mainland United States has been a single female trapped in San Bernardino County, CA, in August 2002. The results of DNA tests to determine the origin of the Medfly were inconclusive, though they did show a banding pattern that may be consistent with Medfly from Central America, South America (except Venezuela and most of Brazil), Mediterranean countries, or Sub-Saharan Africa. 4 4 DNA tests are actually better at clarifying where Medflies did not originate, as opposed to where they did originate. In this case, DNA tests revealed that banding patterns are not consistent with Medflies in Hawaii, Venezuela, and most of Brazil. One commenter questioned whether APHIS has the resources available to effectively carry out and enforce the new import program, especially given congressional proposals to transfer the 3,200 APHIS employees at ports of entry to a proposed Department of Homeland Security. The commenter stated that, given the uncertainty surrounding the move of port personnel to the Department of Homeland Security, the reentry of Spanish clementines should be delayed. APHIS has reviewed its resources and believes it has adequate coverage in Spain and across the United States to ensure compliance with this final rule. We have no reason to believe that inspectors and preclearance personnel will be unable to continue to carry out their current responsibilities in the event that they are moved to the proposed Department of Homeland Security. One commenter noted that APHIS states that it is imposing a combination of measures aimed at achieving probit 9 protection from entry on Medfly into the United States. These measures comprise (1) pre-export controls in orchards and inspection at point of export, (2) cold treatment, extended by 2 days compared with previous conditions, and (3) post-import inspection. This commenter asked that we explain what contribution each step makes to achieving probit 9 protection. Probit 9 was established by A.C. Baker in 1939 as a useful concept when trying to assess mortality of commodity treatments against fruit flies. 5 5 Baker, A.C.. 1939. “The Basis for Treatment of Products Where Fruitflies are Involved as a Condition for Entry into the United States.” Circular No. 551. US Department of Agriculture, Washington, DC. APHIS considers “probit 9 protection” to be relevant only to cold treatment in this case. As stated earlier in this document and in the proposed rule, the term “probit 9” refers to a level or percentage of mortality of target pests (i.e., 99.9968 percent mortality or 32 survivors out of a million) caused by a control measure. APHIS has historically used the term “probit 9” in association with the mortality rate caused by commodity treatments (including vapor heat, high temperature forced air, methyl bromide, and cold treatments) for fruit flies. We do not believe the term can be assigned generally as a measure of success of a pest-excluding regulatory approach if the term is used as a representation of the risk reduction potential of (1) a systems approach to pest management or (2) any combination of treatment and other types of safeguards other than treatment. This is to say that APHIS uses the term only as a representation of the level of mortality of pests caused by a specific treatment, in this case cold treatment. The level of mortality called “probit 9” is a historical, well-recognized benchmark in the area of phytosanitary security. It has been useful as a benchmark, but recent findings 6 suggest that requiring a probit 9 treatment may or may not be sufficient in a given case (i.e., in situations where there are significant pest populations). Conversely, the use of probit 9 under other circumstances (i.e., in situations with very low or nonexistent pest populations) may be more restrictive than is necessary to protect against pest infestation of imported fruits or vegetables. In such cases, risk analysis is necessary to determine the effect and role of treatment in a given pest-management approach. 6 A detailed consideration of the shortcomings associated with any measure that uses a fixed expression of proportion of mortality (such as probit 9) may be found in: Landolt, P., D. Chambers, and V. Chew. 1984. “Alternative to the use of probit 9 mortality as a criterion for quarantine treatments of fruit fly infested fruit.” J. Econ. Entomol. 77(2): 285-287. In our RMA, APHIS considered that cold treatment approximated the “probit 9” level. We also stated that the risk management analysis for our proposal “considers other risk-mitigating measures as necessary to ensure that cold treatment has the potential to provide approximately a probit 9 level of quarantine security.” Upon further consideration, this statement, and other similar statements made in our proposed rule and supporting documents require clarification. The RMA assesses the extent to which other risk-mitigating measures, in combination with cold treatment, reduce the risk that a mated pair of Medflies could enter the United States via imported Spanish clementines. Population levels have significance in the context of the RMA's calculations regarding the probability that a mated pair of Medflies could enter into the United States via Spanish clementines imported under the provisions of the proposed rule. However, the probit 9 efficacy of cold treatment is not dependent on population levels of Medflies in Spanish production areas in the sense that the same proportion of mortality is expected regardless of the Medfly population density. We have revised our RMA to clarify that fact. To elaborate, if 32 Medflies survive out of each 1 million that are subject to a probit 9 treatment, one should expect that reducing the number of Medflies present to 500,000 would reduce the number of survivors to 16; if 100,000 are treated, then 3 will survive; and so on. We believe this clearly illustrates the relevance and effect of low pest population density, not to cold treatment itself, but to the overall success of a pest-exclusion program. As a general rule, APHIS has required treatments for fruit flies to provide probit 9 mortality in cases where treatment is the only mitigation measure applied against the pest of concern. This is because the level of mortality represented by this benchmark is considered extremely high and stringent, especially when the field infestation rates are low. 7 In this rule, we are requiring a treatment that we are confident will provide a level of quarantine security that is equivalent to probit 9, but we are also requiring that fruit be consistently at low rates of infestation by Medflies in order to ensure that there is a very low probability that Medflies could survive cold treatment and become established in the United States. 7 See footnote 6. Appropriate Level of Protection and Level of Risk Several commenters claimed that, according to the court decision on APHIS's rule authorizing the importation of citrus from Argentina ( Harlan Land Company, et al. vs. United States Department of Agriculture, et al., Case #CV-F-00-6106-REC/LJO (D. Ariz. Sept. 27, 2001)) (referred to elsewhere in this document as Harlan Land Co. ), as a matter of law, APHIS must define what it considers to be a “negligible level of risk” in the context of a rule authorizing the importation of fruit from a disease and pest infested area. The commenters elaborated that APHIS must define what it considers to be a negligible or acceptable level of risk (referred to by one commenter as a “quarantine security standard”), and it must also adequately explain that determination, and claimed that the proposed rule does not do so, nor has APHIS made any attempt to articulate why the issue is not addressed. The commenters stated that without a discussion of the issue, there is no way to judge whether APHIS is meeting the congressional expectation that its regulations will prevent the movement into and through the United States of commodities that “could present an unacceptable risk of introducing or spreading plant pests.” The RMA does not conclude that there is negligible risk associated with such importations. Rather, it concludes that there is a very low likelihood that mated pairs of Medflies could enter the United States via clementines imported from Spain. Furthermore, APHIS does not agree that the Harlan Land Co. court decision requires APHIS to define what it considers to be a “negligible level of risk” in the context of this rule, or any other rule apart from the rule at issue in Harlan Land Co. The term “negligible” is one that was used by APHIS in prior rulemaking and risk analysis documents unrelated to this action to describe risk in a qualitative, descriptive sense. APHIS has never intended that “negligible level of risk” should be interpreted as a term of art, but instead has used the term in its plain meaning. APHIS believes that its decisionmaking is tied directly to the authority given to the Secretary of Agriculture by the Plant Protection Act. Under the Plant Protection Act, the Secretary may prohibit or restrict the importation and entry of any plant product if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. In the case of clementines from Spain, the Secretary has determined that it is not necessary to prohibit the importation of clementines from Spain in order to prevent the introduction into the United States or the dissemination within the United States of a plant pest. This determination is based on the finding that the application of the remedial measures contained in this rule will provide the protection necessary to prevent the introduction or dissemination of plant pests into the United States. One commenter stated that, under the provisions of the World Trade Organization's (WTO) sanitary and phytosanitary (SPS) Agreement, as well as the standards that have been developed to implement the SPS Agreement by the International Plant Protection Convention (IPPC), a definition of the “appropriate level of protection” is the first step that must be taken when a country is considering allowing the importation of a commodity from another country. The commenter claimed that only after the “appropriate level of protection” or the “acceptable level of risk” is established, will the destination country be in a position to consider what phytosanitary measures, if any, need to be implemented in order to assure that its phytosanitary requirements will be met. APHIS believes the commenter has misinterpreted provisions of the SPS Agreement and IPPC standards. The commenter appears to suggest that, under the SPS agreement and IPPC standards, the identification of an appropriate level of protection is a kind of procedural requirement that must be fulfilled prior to each individual instance when the United States considers allowing the importation of a commodity from another country. Under the SPS Agreement and IPPC standards, there is no obligation to complete such a task. Furthermore, guidelines on how to implement SPS Agreement Article 5.5 reveal that an indication of a country's appropriate level of protection: “* * * may be contained in a published statement or other text generally available to interested parties. The statement of the appropriate level of protection may be qualitative or quantitative, and should serve to guide its consistent implementation over time, and also to increase the transparency of the sanitary or phytosanitary regime. Examples might include government policy statements with regard to appropriate levels of protection in response to certain risks, or documents on animal health protection objectives or with respect to plant protection.” 8 8 See http://docsonline.wto.org/DDFDocuments/t/G/SPS/15.DOC. For plant health in the United States, Congress has expressed the United States' “appropriate level of protection” in the Plant Protection Act (a text generally available to interested parties) in the specific discretion provided to the Secretary of Agriculture. The Plant Protection Act authorizes the Secretary to “prohibit or restrict the importation, entry, exportation, or movement in interstate commerce of any plant, plant product, biological control organism, noxious weed, article, or means of conveyance, if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination of a plant pest or noxious weed within the United States.” The Plant Protection Act further elaborates on the Secretary's discretion in carrying out that determination by stating that the Secretary may promulgate regulations requiring permits, or certificates for importation, and may require remedial measures that “the Secretary determines to be necessary to prevent the spread of plant pest or noxious weeds.” The Plant Protection Act ensures that our phytosanitary measures are transparent and implemented consistently over time, and thus is consistent with the guidelines cited above. There is no obligation to express the “appropriate level of protection” quantitatively under either the SPS Agreement or IPPC standards, and Congress, in the Plant Protection Act, did not establish a quantitative expression of the “appropriate level of protection” or require APHIS to set such a quantitative expression. The SPS Agreement obligates members to be consistent in the level of protection they consider appropriate in similar cases. Allowing imports of clementines from Spain reflects consistency with our determinations to allow citrus imports from other countries and regions where Medfly is found. Therefore, this final rule is consistent with our obligations under Article 5.5 of the SPS Agreement. One commenter noted that, in its Regulatory Impact Analysis (RIA) for the proposed rule, APHIS says that it “attempts to maintain the risk of Medfly introduction at an acceptable level in order to protect U.S. agricultural resources and maintain the marketability of agricultural products,” but the Agency does not say what an “acceptable level” of risk is in that document or in the RMA. The commenter also noted that the Appendix 1 to the RMA defines the term “acceptable level,” but it does so tautologically, stating: “Acceptable level means the presence of a hazard that does not pose the likelihood of causing an unacceptable phytosanitary risk.” In other words, “acceptable” means “not unacceptable.” For the reasons stated above, we do not identify an “acceptable level of risk” in either the RIA or the RMA because those documents are, respectively, analyses of (1) the economic effects that could occur under this final rule, and (2) the probability that a mated pair of Medflies could enter the United States via a shipment of clementines from Spain. Neither document is intended to provide a decision or judgment as to whether this final rule provides a defined acceptable or appropriate level of protection, i.e., in a qualitative or quantitative sense. The documents are intended simply to inform the decisionmaker in her consideration of whether to allow the importation of Spanish clementines. Furthermore, Congress stated in § 402(3) of the Plant Protection Act that, “* * * it is the responsibility of the Secretary to facilitate exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests or noxious weeds.” APHIS believes the process it follows in evaluating risks prior to rulemaking on a given subject is consistent with the clearly stated intent of Congress. Regarding the commenter's statement that RMA defines the term “acceptable level” tautologically, the SPS Agreement employs a similar approach. The SPS Agreement defines “appropriate level of * * * phytosanitary protection” as “The level of protection deemed appropriate by the Member [country] establishing a * * * phytosanitary measure to protect human, animal or plant life or health within its territory.” We believe this is further testament to the fact that APHIS has no obligation under any of its authorities or international agreements to set a quantitative level of protection that it believes is acceptable. Again, we believe the United States expresses its appropriate level of protection in the Plant Protection Act, which authorizes the Secretary to prohibit or restrict the importation and entry of any plant product if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. One commenter stated that the RMA does not purport to assess the likelihood of Medfly introduction at all; it simply estimates the probability that a mated pair of Medflies will arrive at a suitable location in the United States, and while this is said to be “directly related” to the likelihood of introduction, it is not, according to APHIS, the same thing. The commenters further noted that the RMA does not reach any judgment as to whether the risk of Medfly introduction under the proposed rule is “acceptable.” Instead, it merely asserts that the mitigation activities associated with a 1.5 percent maximum infestation rate decrease the risks of introduction as compared to the baseline of cold treatment alone. The proposed rule addresses the issue by saying the Secretary has determined “that the application of the remedial measures contained in the proposed rule will provide the protection necessary to prevent the introduction or dissemination of plant pests into the United States,” but APHIS does not say what this necessary level of protection is, or how much risk is compatible with “preventing the introduction” of Medflies. The commenter stated that none of the supporting documents conclude that the mitigation measures will “prevent the introduction” of Medflies. While the RMA does not directly assess the likelihood of Medfly introduction quantitatively, it does (1) provide a discussion of the relationship between the likelihood of Medfly introduction and the probability that a mated pair of Medflies could enter the United States in a shipment of Spanish clementines, and (2) provide a baseline figure to which the likelihood of introduction can be compared. In order to quantitatively assess the likelihood of introduction, additional analysis would be required to evaluate the possibility that a mated pair of Medflies that has entered the United States in Spanish clementines and arrived in a suitable area can then (1) find a host, (2) find fruit that is sufficiently mature in which to oviposit, (3) oviposit viable eggs, and (4) avoid death by dessication, heat or cold, or other factors. The effect of these other variables on the ability of a mated pair to survive, reproduce, and spread would, in all cases, further reduce the likelihood that Medfly could be introduced into the United States below the already very low probability that a mated pair of Medflies could enter the United States via Spanish clementines. One commenter stated that the Harlan Land Co. court decision made it clear that “unless an agency describes the standard under which it has arrived at its conclusion, the court has no basis for exercising its responsibility to determine whether the agency's decision is arbitrary, capricious, an abuse of discretion, or otherwise in avoidance with the law.” The commenter stated that according to the court's statement, an agency must cite information to support its position; without data the court owes no deference to an agency's line-drawing. APHIS believes that the standard under which it has arrived at its conclusion is tied directly to the authority given to the Secretary of Agriculture by the Plant Protection Act. Under the Plant Protection Act, the Secretary may prohibit or restrict the importation and entry of any article if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into the United States or the dissemination within the United States of a plant pest or noxious weed. In the case of clementines from Spain, the Secretary has determined that it is not necessary to prohibit the importation of clementines from Spain in order to prevent the introduction into the United States or the dissemination within the United States of a plant pest. Several analyses (the RMA the cold treatment evaluation, the ORACBA analysis, and the judgment of USDA technical experts), provide the basis for the Secretary's finding that the application of the remedial measures contained in this rule will provide the protection necessary to prevent the introduction or dissemination of plant pests into the United States. Furthermore, the Secretary's determination is consistent with the congressional charge that she “facilitate exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests or noxious weeds.” Trade Issues, International Agreements, and Equivalence One commenter claimed that any delay that prevents the re-entry of clementines into the United States beyond the beginning of the next shipping season would constitute unreasonable delay in violation of the Administrative Procedure Act and in contravention of the U.S. Government's WTO obligations. Under the Administrative Procedure Act, USDA's rulemaking review policy, and the requirements of several Executive Orders, APHIS must follow certain procedures in the drafting and review of rulemaking documents. This process takes time. APHIS must consider issues raised in comments submitted before the close of the comment period, and then determine what action to take on its proposal given the issues raised by commenters. It must then draft a rule that documents its response to comments, and must circulate the rule through a significant review and approval process. APHIS is committed to rulemaking based on science and according to the requirements of the Administrative Procedure Act, and will not produce a final rule until we have carefully considered the issues raised by commenters and have followed our formal review process. This is consistent with member obligations under the WTO SPS Agreement. Three commenters stated that the proposed rule violates WTO prohibitions against discriminatory trade practices by requiring an extra 2 days of cold treatment for Spanish exports that are not required of clementine exports from other countries susceptible to Medfly infestation. In the October 15, 2002 issue of the Federal Register , APHIS published an interim rule (APHIS Docket No. 02-071-1) under which all commodities, including clementines from other countries, that are subject to cold treatment for Medfly must be treated under the same treatment schedule that we are requiring for Spanish clementines. Two commenters stated that the proposed rule violates WTO prohibitions against discriminatory trade practices by imposing a field treatment regimen for control of Medfly in Spanish clementine orchards, as well as pre- and post-treatment fruit cutting, but does not require an equivalent field treatment regimen for other countries exporting clementines to the United States from areas susceptible to Medfly infestation. It is true that APHIS has not placed additional pre-treatment, population-limiting requirements on clementines and other Medfly-host fruits and vegetables from other areas where Medflies are present. In the event that emergency measures are required to address a pest risk, APHIS applies them to the extent they are necessary, and APHIS has no evidence to support the conclusion that clementines or other fruits and vegetables from other Medfly-infested areas pose the same risk as clementines from Spain. We have conducted extensive fruit cutting and inspection activities associated with imports of clementines and other fruits and vegetables from other areas, and have not found a single live Medfly larvae. As stated previously in this document and in the proposed rule, given that high Medfly populations in production areas in Spain in 2001 could have caused the infestations discovered that year, APHIS believes it has sufficient reason to adopt specific measures that it believes will ensure against a similar occurence in future years. If we had evidence that suggested an equivalent problem in other regions, we would require equivalent safeguards. The available evidence does not, however, support that course of action. The interim rule for other cold treated commodities, nonetheless, provides that those commodities, like Spanish clementines, will be subject to post-treatment fruit cutting, though fewer of certain commodities will have to be inspected and cut due to their non-preferred Medfly host status. Several commenters stated that the technical trapping protocol, type of trap, baits, frequency of inspection, etc., used by the Spanish growers should mirror the same protocol that is used by APHIS within the United States. The commenters claim that should a temporary Medfly infestation occur in a U.S. production area, the citrus within the established quarantine area cannot, under any circumstances, move to market, and they note that, in contrast, APHIS has proposed to allow foreign origin fruit from permanently infested production areas to be brought into the United States with only the provisos that the pest detections in the export groves are relatively low and the fruit is cold treated. Some commenters also questioned whether cold treatment is actually available to domestic producers in the event of a Medfly outbreak in the United States. We do not agree that the technical trapping protocol, type of trap, baits, and frequency of inspection and other requirements regarding the Spanish clementine import program should mirror the same protocol that is used by APHIS within the United States for a reason the commenter has pointed out: Different requirements are warranted for fruit moving from Medfly-free areas in which there is an outbreak than for fruit moving from generally infested areas. The Spanish are not attempting to eradicate Medfly, nor does APHIS believe they have to do so in order to export fruit to the United States, provided they can mitigate the pest risk posed to the United States by their exports. U.S. producers and agricultural officials have a longstanding policy to eradicate Medfly infestations if they are detected in the mainland United States. 9 Spanish producers use trapping as an indicator of the presence of Medflies in production areas, and use that indicator to trigger bait spray applications that are intended to lower Medfly population densities. U.S. producers and agricultural officials employ trapping programs to monitor for the presence of Medflies in free areas. For these reasons, APHIS does not believe there is a demonstrated need for trapping and bait treatment measures to be the same in Spain as they are in the United States. APHIS would, however, require equivalent measures if the intent of the Spanish program was maintaining Medfly freedom. 9 Hawaii is generally infested with Medfly and uses treatments to certify movements. Furthermore, APHIS disagrees with the commenters' statements that citrus may not move from a U.S. area that is under quarantine for Medfly. In fact, under § 301.78-10(b)(3), APHIS allows the movement of regulated articles, which include citrus fruit, from quarantined areas provided they are treated with the same cold treatment schedule that we use for the importation of Spanish clementines. There are also other treatments available, as specified in § 301.78-10. Several commenters noted that other countries will not accept U.S. fruit if it is 1.5 percent infested with Medfly. Some countries will not accept fruit known to be infested with Medfly, and the United States is one of those countries. To clarify, we are not allowing imported Spanish clementines to be 1.5 percent infested or less upon arrival in the United States. Rather, we are requiring inspection and fruit cutting of 200 randomly selected fruit per shipment of clementines prior to cold treatment. If a single live Medfly is found during inspection in Spain, the entire shipment of clementines will not be eligible for export. If no infested fruit is found upon inspection, that provides a very high level of confidence (95 percent) that the shipment sampled has a low level of infestation (a level that cannot be detected via fruit cutting). Furthermore, according to our RMA, fruit that is 1.5 percent infested or less and that is cold treated has a low probability of carrying a mated pair of Medflies into a suitable location in the United States. If we find one live Medfly larva in a shipment of clementines at the port of entry in the United States, we will reject that shipment. We suspect that the commenters doubt whether other countries would adopt a similar protocol in general for U.S. exports. Such a program would not seem to be necessary, since there currently is no Medfly infestation in the mainland United States. However, we do believe that the Spanish clementine import program could serve as an effective model for exports from Medfly infested areas in the United States to other countries. In the event that such a program is necessary, we would negotiate with foreign Governments to secure export opportunities for citrus and other Medfly hosts from Medfly-infested areas under this same protocol, and we would continue to allow interstate movements of such articles under the requirements of 7 CFR 301.78 through 301.78-10. Cold Treatment Several commenters noted that the time-temperature response surface model contained in the ORACBA analysis can be read to suggest that for treatment periods less than 16 days, a probit 9 level of phytosanitary security may not be achieved even at temperatures of 32 °F, 33 °F, or 34 °F, yet APHIS's revised protocol would allow treatment for only 12, 13, and 14 days, respectively, at those temperatures. One commenter recommended that, until the uncertainty is resolved regarding the lower temperatures and durations of cold treatment, the cold treatment protocol be kept at a minimum duration of 14 days. Other commenters urged APHIS to review data relevant to this subject that were recently developed in Australia and South Africa. APHIS has obtained and evaluated data collected in Australia by its Department of Agriculture and Horticulture Australia regarding time/temperature combinations that provide apparent complete mortality of Medfly. 10 Copies of that data are available from the person listed under FOR FURTHER INFORMATION CONTACT. These data have also been factored into an updated version of the ORACBA analysis. In short, the data provide evidence that the longer durations of cold treatment (16 days/35 °F, and 18 days/36 °F) are likely to provide a very high level of quarantine security (probit 9 or above). 10 De Lima, C.P.F, A. Jessup, and R. McLauchlan. 2002. “Cold disinfestations of citrus using different temperatures X time combinations.” Horticulture Australia Ltd. Project Number: CT96020. The specific South African data cited by commenters were not submitted to APHIS by commenters. We were able to communicate with the persons conducting the study, and the information they provided supports the cold treatment we are requiring under this final rule. Regarding the question of whether cold treatment provides probit 9 mortality at all the proposed time/temperature combinations, APHIS agrees with the commenters that additional statistical or experimental evidence is necessary to continue to support the conclusion that the 12 days/32 °F and 13 days/33 °F combinations provide probit 9 mortality. However, as evidenced clearly by Figure 3 of the ORACBA analysis, there are sufficient data available to conclude that 14 days/34 °F, 16 days/35 °F, and 18 days/36 °F treatments do provide probit 9 level quarantine security. Given that the calculations of risk in our RMA depend on the assumption that cold treatment provides probit 9 mortality, we have removed the 12 days/32 °F and 13 days/33 °F cold treatment combinations from this final rule, due to the unavailability of sufficient data to continue to support those time/temperature combinations as providing probit 9 mortality. Thus, the revised T107-a cold treatment schedule for clementines from Spain will require fruits to be treated according to the following schedule: Temperature Exposure period (in days) 34 °F or below 14 35 °F or below 16 36 °F or below 18 The revised ORACBA analysis provides statistical justification for our selection of the above schedule, and is based on all available data. Some commenters noted that Spanish exporters claimed that their fruit was cooled to 32 °F for 12 to 14 days in 2001, which is as long or longer than the revised protocol would require, and yet a substantial number of Medfly larvae survived that treatment. If the previous statement is true, asked the commenters, how is APHIS's proposed approach different from 2001? We have conducted a review of available cold treatment records for shipments of Spanish clementines into the ports of Philadelphia, PA, and Elizabeth, NJ. The results of our review are as follows: (1) There was no clear pattern for the use of specific time/temperature combinations of cold treatment; and (2) though some shipments of clementines were treated for more days than were required at various approved temperatures, there is no evidence to suggest that the treatment time/temperature combinations cited by the commenter were used on more than a few occasions. In fact, the records show that in 2001, the 10 day/32 °F treatment schedule was the least used of the five options available, perhaps because shippers were hesitant to subject the fruit to the damage that can be caused by freezing temperatures. While our review did reveal that, in some cases, treatments were applied for longer durations (several hours to several days) than was required under the previous treatment schedule, we have no direct evidence that fruit found to be infested with Medfly were treated for more time than was required under the previous treatment schedule. Upon the detection of Medfly in Spanish clementines in 2001, APHIS was able to trace the initial interceptions to particular sea vessels, including the M/V Japan Senator and the M/V Green Maloy. The records for the M/V Japan Senator, which arrived in Elizabeth, NJ, on November 7, 2001, show that each of the eight sea containers imported on that vessel met only the minimum time/temperature combinations provided under the previous treatment schedule. The records for the M/V Green Maloy, which arrived in Philadelphia on November 11, 2001, show that some time/temperature combinations in the 12 compartments on the vessel met only the minimum standards of the previous treatment schedule, while other compartments were cold treated for as many as 3 extra days. Since APHIS cannot trace back the fruit that was found to be infested to a specific hold on either vessel, we cannot know whether the fruit was exposed to more cold treatment than was required. We do know, however, that the infested fruit was held for at least as long as the previous treatment schedule required, which suggests a failure of the previous schedule to provide near 100 percent mortality, but not necessarily a failure of the revised schedule. Furthermore, the approach we use in this final rule also addresses the risk posed by high levels of infestation of imported clementines. There were no such restrictions on infestation levels in 2001. One commenter claimed that APHIS's proposal to extend cold treatment is based exclusively on the recommendation made by a panel put together by APHIS, using studies and scientific literature that are not recent and not credible enough. The commenter stated that cold treatment should not be extended, as any extension should be based upon more detailed scientific studies with internationally accepted credibility. Upon further analysis of all the available data, as stated above, APHIS is amending the cold treatment schedule to allow cold treatment for Medfly only at the longer time/temperature combinations (14, 16, or 18 days, at the temperatures listed above). This change is based on the results of the ORACBA analysis, which essentially combines the results of available cold treatment research and uses a model to assess and show the ability of certain time/temperature combinations to provide probit 9 mortality of Medfly. The ORACBA analysis does not contradict the recommendations of the cold treatment review panel that drew up the cold treatment recommendation document that was cited in our proposed rule. Rather, the ORACBA analysis shows that data are only available to support cold treatment at the longer time/temperature combinations suggested by the panel. Given the clarity of the available data, including data recently made available by the Australian Government, we are confident that our revised cold treatment is science-based. Two commenters questioned whether APHIS allows the use of a single fruit temperature probe in a cold treatment container or ship hold, and stated that a single data point does not allow an estimate of the variation in temperature that normally occurs, and the protocol does not incorporate the necessary treatment time adjustment associated with this temperature variation. The commenters stated that there are very little published data on temperature variation in marine shipments, so the actual level of temperature variation in some shipments may be high. APHIS's cold treatment protocols do not authorize the use of only a single data point in the load. Multiple temperature sensors are required (in the fruit pulp, as well as in the air), and readings from these sensors must print out once an hour during the entire voyage. The larger the cargo space, the more sensors that are required, and sensors must be checked and calibrated before each treatment begins. Furthermore, all cold treatment containers and compartments must be checked and certified by APHIS, and APHIS verifies the treatment records upon arrival of the imported commodity. Given that APHIS requires the use of multiple sensors, given that we require all temperature sensor readings to meet the appropriate treatment schedule, and given the certification requirements for treatment equipment, we are confident that our existing procedure accounts for any temperature variation that may occur during cold treatment. One commenter expressed concern that fruit subject to break bulk shipment and that is not pre-cooled will take 100 hours to reach desired temperatures. Other commenters asked exactly when cold treatment is considered to begin. Others questioned whether the cold chain is broken when fruit is brought to the port for loading onto the ship. Another commenter noted that, under break bulk shipping, cooling fans are not normally operated until 75 percent of the cargo hold is loaded, and stated that this condition further exacerbates the problem of breaking the cold chain. Cold treatment is not considered to have begun until all temperature sensors within a particular compartment in a sea vessel or a container reach treatment temperature or below. If the cold chain is broken at any time during treatment, the treatment must start over, and must be completed in its entirety. As stated above, multiple temperature sensors are used (in the fruit pulp, as well as in the air), and readings from each sensor must be printed out once an hour during the entire voyage. APHIS recommends that the fruit be pre-chilled before loading. However, many foreign seaports have not built cold-storage facilities, and precooling is not essential given that treatment according to the schedules described in this document provide probit 9 mortality. Loading warm fruit mandates a later starting time for the treatment, often several days after the ship has left the port. In some cases, the required number of days may not have elapsed by the time the ship reaches its destination in the United States. This delay may be minimized at the port of embarkation by loading only one compartment at a time, and running the cooling fans during loading. In cases where the treatment is not complete upon arrival, the ship must either remain in port until the cold treatment is completed in the last compartment, or the fruit is consigned to a cold-treatment warehouse on shore, where treatment can be completed or re-initiated. Several commenters stated that APHIS should delay the final rule until additional research on the application of cold treatment is completed, as it has not established why the previous program failed. The commenters cited an ongoing APHIS study to investigate temperature distribution in cold treatment holds in ships to see whether it is necessary to increase the number of temperature sensors in the holds. APHIS's review of the application of cold treatment to shipments of clementines that produced live Medfly larvae yielded no evidence that treatment was improperly applied. Given our analysis of available data on cold treatment, which is documented in the ORACBA analysis, we are confident that the revised cold treatment schedule for Spanish clementines will provide probit 9 mortality. Though there is a temperature mapping study underway regarding the application of cold treatment (which was underway before the 2001 Spanish clementine shipping season), we do not expect the results of the study to suggest dramatic changes to existing guidance on the deployment and placement of sensors in cold treatment compartments and containers. Given the clarity of the available cold treatment data, as discussed in the ORACBA analysis, the probit 9 mortality of cold treatment, and the other mitigating measures contained in this rule, we see no need to delay this final rule. Two commenters stated that APHIS's cold treatment protocol should require that more temperature data be collected in each container to determine the variation in temperature of a load, as this is the only way to ensure that fruit is subject to disinfestation temperatures for the required time period. They claimed that the current protocol potentially allows significant portions of a load to be delivered without adequate treatment, and that a minimum of three temperature probes per unit of fruit are needed. One of the commenters stated that USDA research reports published in the 1980's indicate that the fruit temperature range in a refrigerated container is typically about 3 °F, and based on that figure, single temperature monitors measuring average temperatures could fail to reveal temperatures above the level permitted by the treatment schedule. APHIS requires the use of multiple sensors, given that we require all temperature sensor readings to meet the appropriate treatment schedule, and given the certification requirements for treatment equipment, we are confident that our existing procedure accounts for temperature variation that may occur during cold treatment. For shipping containers, we require a minimum of three temperature sensors to be placed in fruit pulp. For sea vessel compartments, we require a minimum of four temperature sensors, but the number required may be larger, depending on the size of the treatment compartment. See Chapter 6 of the Plant Protection and Quarantine (PPQ) Treatment Manual 11 for additional information. 1 See http://www.aphis.usda.gov/ppq/manuals/pdf_files/TM.pdf. Several commenters noted that in December 2001, when the Government of Spain proposed that APHIS extend the cold treatment on two of the vessels then docked in U.S. ports with a view to permitting the fruit to enter the United States if the treatment were successful, APHIS rejected the approach, saying it had “no data to support the efficacy of extending the time or temperature of the approved cold treatment.” These commenters claimed that APHIS still has no such data. At the time of the Government of Spain's proposal, APHIS had not conducted its review of the available data on cold treatment, and would not suggest a remedial measure without a basis in science. Furthermore, for the reasons stated previously in this document, we must disagree with the commenters' conclusion. We believe there are adequate data available to support our revised cold treatment protocol. One commenter stated that the effects of precooling on the ability of Medflies to survive cold treatment are not known and pointed out that the draft workplan for the clementine import program states that “Additional long-term research will be needed to determine if the rate of precooling has an effect on insect tolerance of the cold treatment.” Studies on other fruit fly species have shown that pre-cooling does not have a significant effect on fruit fly mortality. Whether pre-cooling would have a beneficial effect with respect to Medfly mortality remains to be determined. If so, it is possible that adjustment ( i.e. , shortening) of the treatment schedule would be possible, as available evidence shows that the extended cold treatment required under this final rule already provides quarantine security equivalent to the probit 9 level. Two commenters stated that it is possible that Medflies in Spain may be able to withstand colder temperatures than can more tropical populations of Medflies since most, if not all, cold treatment work has been done on strains of Medfly other than that found in Spain. While it is possible that Medflies in Spain may be able to withstand colder temperatures than some other Medflies, there is no evidence available to support or verify that supposition. There is, however, evidence, which is cited in our risk mitigation analysis, that Medflies have not established in the colder inland areas of Spain where they would be expected to occur if they had become adapted to colder conditions. Indeed, the distribution of Medflies in Spain is consistent with a Mediterranean climate, not a temperate or cold environment. One commenter stated that Medfly larvae have the capability to overwinter in freezing conditions. Larvae may survive brief periods ( e.g. 2 to 3 days) of exposure to freezing conditions, especially if protected from actual freezing by host fruit. Available evidence (cited in the RMA) indicates that larvae cannot survive long-term exposure ( i.e. , 3 to 4 days) to freezing temperatures. One commenter stated that the statement in the proposed rule that APHIS inspectors will examine the cold treatment data prior to clearing an incoming shipment is very troubling, as it infers that this might not have been occurring previously even though the PPQ Treatment Manual cold treatment protocol requires a review of the treatment logs or charts for any irregularities that might have occurred during treatment (and, time permitting, examination of the load and compartments) prior to clearance of any cold treated shipment. APHIS always reviews the cold treatment records of each compartment or container that contains imported cold treated fruits and vegetables. For each imported shipment, an inspector reviews the treatment charts to ensure that the treatment cold chain was uninterrupted and that the time/temperature combinations meet the required treatment schedule. Our statement in the proposed rule was intended to reinforce this requirement, not to imply it had not been applied. One commenter stated that methyl bromide fumigation is a proven treatment meeting a probit 9 standard of quarantine security with regard to Medfly infestation, and that based on applications of methyl bromide to mandarin crops (a citrus fruit similar to clementines), methyl bromide treatment would have minimal aging effects on the fruit and little to no cosmetic effects provided that the fumigation was properly applied. The commenter pointed out that the established PPQ treatment schedules for citrus for methyl bromide use is listed as T101-w-1-2 in the PPQ Treatment Manual. The treatment referred to by the commenter is listed in the PPQ Treatment Manual as an approved Medfly treatment for citrus moving interstate within the United States. However, APHIS only employs that treatment for use as a precautionary treatment for fruit moving from areas near areas where Medfly has been trapped. Treatment T101-1-2 does not provide probit 9 mortality, and there is no approved methyl bromide treatment for citrus that provides probit 9 mortality of Medfly. Confidence Building and Limited Distribution Many commenters had concerns about the potential limited distribution of Spanish clementines. The proposed rule explained that APHIS was considering restricting the distribution of imported Spanish clementines to non-citrus producing States for the first year of the program as a confidence-building measure. With limited distribution, clementines would not be eligible for distribution in California, Arizona, Texas, Florida, Louisiana, Puerto Rico, the U.S. Virgin Islands, the Northern Mariana Islands, Guam or American Samoa. Four commenters stated that such a requirement is unwarranted and unjustified given the findings of the RMA, and especially given the new stringent controls included in the proposed rule. One commenter stated that the requirement would be contrary to the provisions of the SPS Agreement, which requires measures to be based on scientific principles. Twelve other commenters stated that limited distribution was warranted, and each had different ideas as to what APHIS's limited distribution protocol should actually entail. Some commenters claimed that distribution should be allowed only in States without Medfly host material and conditions for Medfly survival. Others stated that distribution should not be allowed in citrus-producing States or States that border citrus-producing States. Other commenters agreed with APHIS's original suggestion. One commenter suggested that APHIS limit distribution for 2 years rather than 1 year to build added stakeholder confidence in the new program. APHIS has determined that, in order to ensure the success of our new approach, it is necessary to limit the distribution of Spanish clementines to non-citrus producing States during the upcoming (2002-2003) Spanish clementine shipping season. This means that, under § 319.56-2jj(i) of this final rule, the importation and distribution of Spanish clementines will not be allowed in Arizona, California, Florida, Louisiana, Texas, Puerto Rico, the U.S. Virgin Islands, the Northern Mariana Islands, Guam and American Samoa 12 during the 2002-2003 shipping season, and all boxes of Spanish clementines will be required to bear the following statement: “Not for distribution in AZ, CA, FL, LA, TX, Puerto Rico, and any other U.S. Territories.” All labeling must be large enough to clearly display the required information and must be located on the side of the cartons to facilitate inspection. APHIS has determined that this measure is necessary to provide added protection to areas in the United States that are most vulnerable to Medfly establishment. 12 Hawaii produces citrus, but is generally infested with Medfly, and therefore is not included in the list of citrus-producing States where distribution of Spanish clementines will be prohibited for the 2002-2003 shipping season. Our strategy is limited to fewer States than some commenters would have preferred because we do not believe it is necessary, especially given the RMA's characterization of the likelihood that a mated pair could enter the United States via imported Spanish clementines, for us to temporarily prohibit the distribution of Spanish clementines in any States except those where Medfly could become established for the long term. We acknowledge that Medfly attacks many crops other than citrus, and that those crops are produced in some non-citrus producing States, but those States do not have favorable climatic conditions and sufficient host material present throughout the year to support Medfly establishment. APHIS is adopting this requirement on a temporary basis to protect the most sensitive agricultural production areas of the United States from infestation with Medfly. Therefore, we are confident that we are well within our rights as a WTO member country. Several commenters stated that limited distribution is not good regulatory policy and does not work, as shipments of commodities entering California from other States have been found to contain live Medfly larvae. The commenters noted that the California Department of Food and Agriculture routinely finds exotic pests in parcels handled by the U.S. Postal Service and commercial delivery firms at various locations in California and stated that USDA cannot implement a 100-percent effective program to stop transshipment of clementine fruit from other States into California. APHIS has had success with compliance systems for limited distribution of fruits and vegetables. The keys to this success have been communication, labeling, trade verification, and enforcement. Communication of regulations for limited distribution has been made via public notice, APHIS Industry Reports, internet websites, direct mailings to members of the Produce Marketing Association and American Trucking Association, and issuance of compliance agreements and permits. Distribution statements are required on the shipping boxes for all limited distribution commodities, as will be the case for Spanish clementines. These statements inform the importer, shipper, or market owner of the areas in which the products are prohibited from being distributed. Verification of commodity and required labeling takes place at the initial port of entry and at internal markets within the United States. Commodities found to have been moved in violation of limited distribution requirements are recalled and/or destroyed. Reports of illegal movement are investigated and civil penalties are issued to violators as appropriate. For example, APHIS has monitored importation and compliance with the limited distribution of Mexican avocados since 1997. Compliance has been 98 to 99 percent by volume during the past 5 shipping seasons. In spite of an increased volume of imports, the 2001-2002 season saw a notable decline in violations over past years. In the 2001-2002 shipping season, APHIS had three violations under investigation for illegal transshipment to Tennessee and Georgia. Approximately 85 boxes were found in several unapproved markets, of which 80 (1 shipment) were reported to agricultural officials by the receiver in Georgia and returned. We are confident that limited distribution of Spanish clementines can be enforced and can work, as shown by past experience. Two commenters stated that APHIS should consider a trial period during which limited volumes of clementines would be allowed to be imported to northern-tier States for a minimum of one shipping season, so as to ensure that the system works. As stated in previous responses, APHIS is confident that limiting distribution to non-citrus producing States should be adequate to provide confidence that the new approach works, especially given the very low probability of a Medfly infestation identified in the RMA, which does not even consider limited distribution as a mitigation measure. Operational Workplan Several commenters stated that, in order to truly understand whether or not the risk mitigation measures chosen will provide an appropriate level of protection, APHIS's analysis must contain the workplan that will be used to implement the mitigation strategy chosen. The commenters said that, without the workplan, there is no way for any cooperator or other stakeholder to ascertain if the measures chosen will be effective. The workplan referred to by commenters is, in essence, an operational agreement between APHIS and other parties (the Spanish Government and a group representing clementine exporters) as to the responsibilities of each for the operation of the preclearance program. The provisions of the workplan intertwine with the regulations and are more detail-oriented. When APHIS designs a regulatory approach for a particular issue, it places or proposes to place all measures deemed to be necessary according to risk analysis in the Code of Federal Regulations. If a specific measure is not relevant to our calculations of risk, that measure may be included in the regulations, and it may not. There is no bright line between what is included in a workplan and what is included in the regulations, save that the regulations must include all provisions necessary to properly enforce the approach evaluated by risk analysis. As a longstanding matter of policy, APHIS does not make preclearance workplans available for public comment, nor does it have the intention of doing so in this case, though APHIS has, on some occasions, consulted stakeholders (who are not signatories of the workplan) on the contents of such workplans. In fact, at the request of stakeholders, APHIS has met with several State plant health officials as to the content of the preclearance workplan for this rulemaking. Nonetheless, APHIS does not believe that the contents of the workplan should be included in the rulemaking at hand. To elaborate, APHIS has received a number of comments urging specific handling of trapping and monitoring activities in Spain— i.e. , commenters have suggested the use of a certain fruit fly traps, and certain spacing of trap locations. APHIS believes that such points do not have to be included in the rulemaking at hand, given that the rule is designed to provide for a measure of performance that will be demonstrated primarily via inspection and fruit cutting. Moreover, regardless of what trap is used and how the traps are spaced, under this rule, growers of Spanish clementines must ensure that products submitted for export to the United States have a low Medfly infestation level (a level that cannot be detected via fruit cutting). If they do not meet this standard, clementines intended for treatment will be rejected. APHIS will reject a shipment of fruit presented for export if it is found to contain live larvae upon fruit cutting. In short, if the fruit is found to be infested, it will be rejected. If fruit is not found to be infested, the extended cold treatment will provide that the fruit can be safely imported. One commenter stated that without the workplan, there is no way for any cooperator or other stakeholder to ascertain if there is sufficient APHIS oversight planned in Spain. The commenter stated that the workplan should allow APHIS unfettered access to production areas and packing and shipping facilities, regular auditing of Spanish records, and other procedures to ensure that APHIS personnel verify compliance with the terms and conditions of the operational workplan. The requirements described in the proposed rule and this rule clearly state that the Spanish Medfly management program must provide that clementine producers allow APHIS inspectors access to clementine production areas in order to monitor compliance with the Medfly management program, and that all trapping and control records kept by the Government of Spain or its designated representative must be made available to APHIS upon request. APHIS will have inspectors working full time in Spain on the verification of the Spanish clementine import protocol-including inspections at the port of export and production area monitoring. The inspectors will be present to conduct and monitor fruit cutting at the exporting port, and will be able to review records kept by the Government of Spain regarding its management program. Only APHIS personnel and personnel of Spain's Plant Protection Service will be allowed to conduct fruit cutting, and any fruit cutting performed by the Government of Spain will be supervised by APHIS. Infestation Levels, Inspection, and Fruit Cutting Several commenters expressed concern or confusion over our reference to a 1.5 percent level of infestation. One commenter stated that allowing 1.5 percent of imported Spanish clementines to be infested is unacceptable, and that 1.5 percent is a high level of infestation of any pest, even in the field, while several other commenters claimed that our selection of that level of infestation is not supported by science. We recognize that our reference to a 1.5 percent level of infestation of Spanish clementines may have caused confusion among commenters. To clarify, under this rule, the detection of a single live Medfly during any sampling of clementines will result in the rejection of the shipment sampled. Hence our actual target infestation level of fruit is zero, not 1.5 percent. However, as a practical matter, it is impossible to sample a sufficient number of fruit to arrive at a statistically valid conclusion that the fruit sampled is Medfly-free. Therefore, we have selected a sampling rate (200 fruit per shipment) that provides a high level of confidence that we will be able to detect low levels of Medfly infestation in clementines from Spain. This particular level of inspection was selected because inspection and fruit cutting at lower rates would provide decreased confidence in our ability to detect low-level infestations of fruit, and because inspection and fruit cutting at higher rates would either not be practical from an operational standpoint or would not measurably improve confidence in our ability to detect such infestations. While this sampling rate was represented in the proposed rule as a measure that provided 95 percent confidence that we could detect Medfly in fruit that were no less than 1.5 percent infested, the same sampling rate will also provide a relatively high degree of confidence that even lower levels of Medfly infestation could be detected. For example, based on established hypergeometric sampling rates shown in the table below, we would still have a relatively high level of confidence (75 percent) that we could find an infested fruit if the unit sampled is only 0.70 percent infested with Medflies. Percentage of fruit infested with Medflies Confidence in detection, assuming 200 fruit sample 1 (in percent) 0.05 9.52 0.10 18.13 0.11 19.76 0.12 21.36 0.20 32.99 0.30 45.17 0.40 55.15 0.50 63.32 0.60 70.00 0.70 75.47 0.80 79.95 0.90 83.61 1.00 86.61 1.10 89.06 1.20 91.06 1.30 92.70 1.40 94.04 1.50 95.14 1.60 96.03 1.70 96.76 1.80 97.36 1.90 97.85 2.00 98.24 1 Assuming shipments of clementines are within the maximum and minimum sizes described in this final rule (166,000 to 4.5 million fruit). While this sampling rate (200 fruit per shipment) provides a high level of confidence that we can detect low levels of infestation, we acknowledge that some small percentage of infested fruit may be missed during sampling. However, as discussed elsewhere in this document, the calculations of our RMA suggest that the application of cold treatment to such fruit would result in a very low probability that such fruit could serve as a pathway for Medfly to enter the United States into a suitable area. If exporters of Spanish clementines are to avoid having shipments of clementines routinely rejected by inspectors, they must ensure that the infestation level of fruit is below detectable levels. Furthermore, given that APHIS may shut down the export program if shipment rejection rates rose above 20 percent in a given month, we believe that an appropriate target maximum infestation level for fruit presented for export would have to be well below 1.5 percent. Again, we did not intend to identify a 1.5 percent level of infestation as a target infestation level for the fruits in the field. Given this fact, and the confusion expressed by commenters, we believe it is necessary to clarify and revise part of our proposal. Specifically, § 319.56-2jj(c)(1) of our proposed rule required that “* * * bait treatments * * * be applied in the production areas at a rate appropriate to maintain the level of infestation of clementines by Mediterranean fruit flies at 1.5 percent or less.” This proposed language was inappropriate, because maintaining levels of infestation at 1.5 percent would result in the majority of shipments of clementines being rejected. In addition, the responsibility for operating the Medfly management program in Spain resides with the Spanish Government, and this rule contains no provisions for APHIS or any other party to verify levels of infestation of clementines in the field. Rather, this rule provides for such verification through examination of clementines at the port of export. Therefore, we are amending § 319.56-2jj(c)(1) in this final rule to require that “* * * bait treatments * * * be applied in the production areas at the rate specified in Spain's Medfly management program.” We are making this revision because, while we do believe bait treatments need to be applied in order to ensure low levels of infestation of fruit that are presented for export to the United States, we do not believe it is necessary or appropriate for APHIS to specify the level of infestation that must be maintained in production areas via those bait treatments. We are confident, however, that we can appropriately monitor the infestation level of fruit presented for export via inspection and fruit cutting of 200 randomly selected fruit. One commenter stated that APHIS last surveyed the Spanish clementine growing regions in December 2001 and has no more recent data. The commenter stated that, given the age and unreliability of Spanish Government data on trapping and pest populations, APHIS cannot determine with any confidence the type of spraying required and the duration and frequency of the treatments necessary to reach the 1.5 percent desired level. APHIS believes that a well-maintained trapping program can be used as an accurate indicator of the localized prevalence of Medflies. We do not believe that trapping is precise enough to accurately determine infestation levels of fruit, though it is useful as an indicator for when bait treatment applications are necessary. APHIS believes that inspection and fruit cutting provide a more effective means to determine the level of infestation in fruit submitted for cold treatment than can trapping. For this rule, we use inspection and fruit cutting as a means of determining the level of infestation of Spanish clementines. Two commenters claimed that APHIS has presented no data showing that an infestation rate of 1.5 percent or less, combined with cold treatment, will successfully prevent mated pairs of live Medfly larvae from entering the United States. The commenters noted that direct sampling data compiled by APHIS inspectors from vessels unloaded at ports of entry in 2001 showed an overall average infestation rate (0.16 to 0.18 percent) that is an order of magnitude lower than the maximum infestation rate (1.5 percent) contemplated under the proposed rule, yet there were multiple finds of live Medfly larvae in Spanish clementines last year. The commenters questioned the particular significance of a 1.5 percent infestation level, asked why it is a critical control point, and stated its selection appears to be arbitrary. As stated in this document, we believe it is highly likely that infestations of imported Spanish clementines were due to the inability of the cold treatment schedule to provide probit 9 mortality. We are confident that the revised treatment schedule, in combination with the reduction in Medfly infestation levels ensured via fruit cutting, provide that needed quarantine security. Regarding the infestation levels in 2001, APHIS acknowledges that all samples taken after the initial infestations of 2001 were detected revealed low level infestations. It was not possible to randomly (that is, in an unbiased manner) sample fruit from shipments that had already been distributed and/or sold through retail outlets; given that those early-season shipments are the origin of first interceptions of live Medfly larvae in 2001, APHIS is unconvinced that the level of infestation observed in samples taken later in the shipping season are representative of the level of infestations of early season shipments. The unprecedented, numerous reports of live larvae from retail outlets and ports suggest that high densities of live larvae were indeed associated with early season shipments. As stated earlier in this document, the sampling rate used for inspecting clementines presented for export was selected primarily because it provides a high level of confidence of detecting low level infestations of clementines. For this reason, we do not agree that its selection was arbitrary. We believe that the RMA provides ample evidence that the level of Medfly mortality caused by cold treatment (probit 9 or above), in conjunction with the low levels of pest infestation ensured via fruit cutting reveal that there is an extremely low likelihood that a viable mated pair of Medflies would enter the United States with imported Spanish clementines. Furthermore, as discussed earlier in this document, APHIS is unconvinced that the level of infestation observed in samples taken later in the shipping season (presumably, the samples referred to by the commenter) are representative of the level of infestation of early season shipments. APHIS has assumed that the infestations associated with early season shipments were higher than average. This is a reasonable assumption based on the available evidence, which includes the unprecedented and numerous reports of live larvae, the higher than average trap captures in Spain during the growing season, and the higher than average temperatures in Spain during the growing season. One commenter stated that the 1.5 percent value was chosen not because it was shown to provide any particular level of phytosanitary security, but because 200 fruit per shipment was the maximum amount APHIS felt it was capable of inspecting in a reasonable amount of time and at reasonable expense. As stated in response to the previous comment and others, the 200 fruit per shipment sample size was selected primarily because it provides a practical means to verify with a high level of confidence that fruit is infested at low levels. We stated in our proposed rule that we consider fruit cutting (200 randomly selected fruit per shipment) to provide a statistical basis on which we can infer whether the shipment inspected is 1.5 percent infested or greater. The use of this measure in combination with cold treatment will result in a very low probability that a viable mated pair of Medflies would enter the United States with imported Spanish clementines. Several commenters noted that after the first shipping season, the pre-treatment sampling rate would not ensure with 95 percent confidence that sampled fruit is 1.5 percent infested or less, but rather that is 3.0 percent infested or less. The commenters also noted that in future years, the sampling rate could be reduced to 76 fruit per shipment, and the sampling would provide only a 90 percent confidence level that the infestation rate is no greater than 3 percent. The commenters questioned how the findings of the risk management analysis are affected by changing the sample size from 200 to 100 to 76 fruit. Some of the commenters noted that the lower sampling amounts are inconsistent with USDA's Pre-Clearance Program Guidelines, which define “quarantine security” as “a level of control which assures a 95 percent confidence level that a pest population will not become established based on the inspection/treatment certification procedure(s) used when considering the biology and ecology of the pest species.” Commenters stated that there is no biological justification for reducing the sampling rate in one year based on rejection rates of shipments in the previous year since infestation rates in one year may differ substantially from rates a year earlier, and stated that APHIS has provided no evidence that there is any correlation between infestation rates in different years. APHIS does not necessarily agree with the commenters' assertion that there is no biological justification for reducing the sampling rate in one year based on rejection rates of shipments in the previous year, though we do acknowledge that we did not provide a clear justification for such a measure in the proposed rule. To elaborate, if orchards in Spanish clementine productions areas are well managed for Medfly on an ongoing basis according to specific measures contained in a pest management program, then there would be a clear connection between the Medfly populations in those areas from one year and the next. Nonetheless, given that the RMA does not consider the effect of decreasing the pre-treatment fruit cutting sample size from one year to the next, in the final rule we are simply requiring that fruit be cut at a rate of 200 fruit per shipment, as that level of inspection is the only one evaluated in the RMA. Two commenters stated that the maximum size of a shipment or lot should be set according to the number of boxes, not the number of pallets, and noted that the maximum lot size specified in the rule appears to be smaller than that specified in discussions regarding the program workplan. Several commenters expressed concerns over our explanation for what constitutes a “shipment” of clementines under the proposed rule. Those commenters suggested that the rule needs a clear definition of the term “shipment” as it relates to cutting requirements, and argued that the proposed rule does not specify how it will be made clear, in advance of an inspection, what constitutes the particular “shipment” when fruit is presented for inspection. As pointed out by one commenter, the maximum size of shipment described in the proposed rule was 120 pallets (approximately 43,243 boxes). This figure was incorrect, as we allow a maximum size shipment of 200,000 boxes (555 pallets) under the operational workplan. We have corrected this error in this final rule. 13 Further, due to the confusion caused by our use of the terms “shipment” and “lot,” we are making changes in the final rule based on these comments. In our final rule, a lot of clementines is considered to include a number of units of clementines that are from a common origin ( i.e. , a single producer or a homogenous production unit 14 ). The definition of the term shipment depends on the context in which it is used. Specifically, the definition depends on whether or not fruit has been treated. The term can refer to one or more lots of clementines that are presented to an APHIS inspector for pre-treatment inspection. Such a shipment may not include more than 200,000 boxes of clementines (555 pallets). The term can also refer to one or more lots of clementines that are imported into the United States on the same conveyance. These definitions are included in a revised § 319.56-2jj(k). Furthermore, inspectors must be able to easily distinguish one shipment from the next, and exporters are required to present their shipments for inspection in an orderly manner to facilitate inspection. 13 This change has no effect on calculations of risk, as the same level of confidence (95 percent) is provided by inspection and cutting 200 fruit out of either 120 pallets or 555 pallets, according to hypergeometric sampling rates. 14 A homogeneous production unit is a group of adjacent orchards in Spain that are owned by one or more growers who follow a homogeneous production system under the same technical guidance. The fruit produced by these units is pooled and packed together, and all orchards in the group are regulated as one unit in the event that traceback of infested fruit is necessary. One commenter stated that the proposed rule does not say what is meant by the term “orchard,” and requested that APHIS clarify the term's meaning. The commenter noted that it is unclear how APHIS will determine whether two shipments with infested fruit are from the same “orchard” or how APHIS will determine the bounds of the “orchard” that is to be removed from the export program. We have added a definition for the term “orchard” to § 319.56-2jj(k). For the purposes of this rule, the term “orchard” refers to each plot on which clementines are grown that is separately registered in the Spanish Medfly management program. Some orchards could be owned by one person, and some could be owned by several persons (in Spain, such cooperatives are called “homogenous production units”). Some orchards could be less than an acre in size, while others could include hundreds of acres. APHIS will be able to determine the origin of infested fruit via box markings that are required under this final rule. The box markings will provide a means to identify the particular orchard owner or homogeneous production unit from which infested fruit originated. In order to confirm that fruit are eligible under the export program, APHIS checks the box markings on cartons submitted for cold treatment to verify the orchard's status in the export program. One commenter noted that the pretreatment fruit cutting sample size represents too small a percentage of the actual sample itself. The commenter noted that the samples represent .0012 percent of the smallest shipment of fruit, and .0002 percent of the largest shipment respectively. The commenter stated that inspecting and cutting a small random sample of fruit does not ensure the shipment is clean prior to cold treatment. These sampling techniques are not designed to ensure that fruit is pest-free. Rather, sampling is intended to provide confidence that the infestations levels in fruit are low enough to ensure a low probability that a viable mated pair of Medflies would enter the United States via imported Spanish clementines. As stated in response to the previous comment, the maximum size of a shipment would be 200,000 boxes, containing approximately 4.5 million fruit. Even so, according to established hypergeometric sampling rates, whether cutting 200 fruit out of (1) a 166,050 fruit sample or (2) a 4.5 million fruit sample, if samples are randomly selected, the negative results would provide 95 percent confidence that the unit sampled is less than 1.5 percent infested. One commenter stated that if Medflies at any stage of development are discovered in two or more shipments in one season from the same orchard, the orchard should be removed from the export program until it can certify compliance with Medfly management and commodity export programs, rather than only being removed for the remainder of the shipping season. APHIS believes that fruit cutting is the most effective means to determine the infestation level of fruit presented for cold treatment, and thus does not agree that such a review is needed to qualify an orchard for re-entry into the export program. If the orchard is not managing Medfly populations effectively, that fact will be evident in fruit cutting required under this rule. One commenter stated that APHIS should specify the cutting rates and procedures that will be used once the fruit reaches the United States or the basis on which the rates will be determined. Post-treatment fruit cutting is not considered as a mitigation measure in the calculations of risk of the RMA. Since the RMA estimates a very low probability that a viable mated pair of Medflies would enter the United States with imported Spanish clementines under the other provisions of this rule, we see no need to specify the level of post-treatment fruit cutting in the rule itself. We will continue to require post-treatment fruit cutting of clementines, and will cut 1,500 fruit per bulk shipment and 150 fruit per shipping container for the first shipping season. Sample sizes may decrease in future years based on the success of the program. Two commenters claimed that the reliability of fruit cutting as a sampling technique is questionable, at best. One of those commenters cited studies indicating that, on average, inspectors will identify only 35 percent of infested fruit, noted that the infestation rate of Spanish clementines could actually be as high as 4.3 percent during the first shipping year when the 1.5 percent limit applies (1.5 percent ÷ 0.35 = 4.3 percent), and argued that cutting a statistically determined sample will not ensure that the infestation rate on fruit accepted for shipment does not exceed 1.5 percent. The other commenter stated that the effectiveness of inspection is dependent on both the skill and qualifications of the personnel carrying out the exercise and the standardization of the activity. The commenter stated that without assurances that the fruit cutting will be undertaken in a uniform, standardized manner and by fully qualified inspectors, there can be no confidence that these procedures, whether applied pre-or post-cold treatment, can accurately measure whether the infestation level in the groves is 1.5 percent or less, or that the Medfly control program, including cold treatment, has been effectively applied. Inspection is a measure used worldwide to mitigate the risk posed by pests that may be present in imported agricultural commodities. APHIS inspectors are trained to find pests in agricultural commodities, and our pest interception records for the past 17 years support this. Since 1985, we have intercepted 485 fruit flies in Citrus reticulata , with 38 of those being Medflies. The RMA discusses the reliability of fruit cutting, and discusses the effect of that variability on its calculations. Given the characteristics of clementines-they are small, easy to peel and cut, and their pulp is translucent-we believe our inspectors will be able to detect Medfly infestations in imported clementines with a high level of confidence. Further, we wish to clarify again that we are not attempting to determine the level of infestation of fruit in the groves where they grow. We are simply attempting to ensure that fruit presented for treatment is infested with Medflies at low levels ( i.e. , levels that cannot be detected via fruit cutting), as discussed earlier in this document. Remedial Measures Two commenters stated that if live larvae are detected in imported Spanish clementines, the investigation should be performed jointly by APHIS and Spain. The commenters requested that APHIS ensure that access to all relevant data and samples is provided to the importer and the Spanish authorities to permit independent verification of the findings of the U.S. inspectors. APHIS is not opposed to Spain participating as appropriate in an investigation that may be necessary if Medflies are found in imported Spanish clementines, and we will share data relevant to such findings with the Spanish. However, APHIS will not delay any part of such an investigation based on the availability, or lack thereof, of Spanish Government personnel. Several commenters stated that fruit should not be destroyed if it arrives at a U.S. port and (1) treatment has not been properly applied or (2) fruit are found to be infested. The commenters expressed concern that the proposed rule allows for the destruction of improperly treated or infested fruit, and suggested that APHIS apply the least drastic measures necessary at the port of entry in the event that Medfly is detected in Spanish clementines. APHIS gives fruit importers the choice of what to do with shipments of fruit that are found to be infested with pests, unless the exporter's choice poses a risk that pests could be introduced into the United States. For instance, APHIS would not require the destruction of fruit that is found, upon inspection, to be infested with Medflies if the fruit can safely be reexported. One commenter asked if APHIS has ever considered requiring exporting countries to put up a performance bond to ensure against the devastation of American agriculture in the event that legally imported fruit introduce serious agricultural pests into this country. The idea of a protective bond to be paid by a foreign region to U.S. producers in the event that imported fruit causes a catastrophic pest emergency in the United States is not a new idea, nor is it a practical one. Such “insurance” against pest infestation and loss of agricultural production has been determined to be contrary not only to the will of foreign exporters, but to the will of domestic exporters, who would be expected by other countries to put up similar bonds for their exports. The matter is further complicated by the fact that it is very difficult to tie an outbreak to a specific source, as per past experience. For these reasons, the use of such bonds is considered impractical. One commenter stated that the handling of potentially infested cargo at ports of entry is subjective and criteria for suspension of the program is ambiguous. The regulations do not cite specific courses of action to be followed in the event that infested fruit are intercepted at the port of entry, as each such situation could require a unique reaction. APHIS believes that decisionmaking related to such events is best handled on a case by case basis, and we believe our position is well within the authority given to the Secretary by Congress. One commenter questioned whether APHIS, upon finding live Medflies in imported Spanish clementines, would allow consignments which are en route to be inspected, possibly at a higher rate, with appropriate action taken on a case by case basis. As stated in the proposed rule and in this final rule, if a single live Medfly in any stage of development is found in a shipment of clementines being imported into the United States, the shipment will be held until an investigation is completed and appropriate remedial actions have been implemented. If APHIS determines at any time that the safeguards contained in the regulations are not protecting against the introduction of Medflies into the United States, APHIS may suspend the importation of clementines and conduct an investigation into the cause of the deficiency. Risk Analysis One commenter stated that the RMA is not (and does not purport to be) a risk assessment, and noted that, according to the IPPC standard, a pest risk assessment—which evaluates the probability of the introduction and spread of a pest—should be performed as a predicate to conducting a risk mitigation analysis to select the most appropriate pest risk management options. The commenter claimed that APHIS has not performed a pest risk assessment as a predicate to conducting the RMA, and thus commenters do not know what APHIS believes to be the probability of the introduction of Medfly under the baseline or mitigated scenario, and it is not possible to determine whether APHIS has selected the most appropriate management options to mitigate the identified pest risk. The events of the 2001 Spanish clementine shipping season suggested that a review of risk mitigation for Medflies was justified, and the risk mitigation document is such a review. Based on the updated decision sheet 15 contained in Appendix 4 of the RMA, and based on more than 20 years of previous imports of Spanish clementines, we have no reason to believe that there are other pests of quarantine significance that require additional risk mitigation, and therefore disagree with the commenter's claim that we have not conducted a pest risk assessment. Indeed, we evaluated the risk posed by all known pests of clementines, and our analysis is documented in the decision sheet, which was made available to the public when the original draft of the RMA was released for public comment on April 16, 2002. 15 Before we began routinely preparing pest risk assessments to inform our decisionmaking relative to commodity import requests, APHIS based its decisionmaking on documents called “decision sheets.” Such documents contained relatively the same information that is contained in modern pest risk assessments, but without the standardized format. We have updated the decision sheet for Spanish clementines to reflect all available pest information and modern pest risk assessment structure, and are confident it considers the risks posed by all pests of Spanish clementines. The decision sheet notes that the following insect pests are known to occur in Spain and are also associated with clementine fruit, and may be imported with the commodity: Ceratitis capitata (Medfly) (Wiedemann) (Diptera: Tephritidae) Ceroplastes rusci (L.) (Homoptera: Coccidae) Ceroplastes sinensis Del Guercio (Homoptera: Coccidae) Cryptoblabes gnidiella (Milliere) (Lepidoptera: Pyralidae) Parlatoria cinerea Hadden (Homoptera: Diaspididae) Parlatoria ziziphi (Lucas) (Homoptera: Diaspididae) Prays citri Milliere (Lepidoptera: Plutellidae) The decision sheet concludes that, even though the seven quarantine pests listed above have the potential of being imported with clementines, all pests listed except Medfly would be easily detected by visual inspection during preclearance procedures. The scale insects, Ceroplastes rusci , Ceroplastes sinensis , Parlatoria cinerea and Parlatoria ziziphi , are relatively large and are located on the surface of the fruit. The larval stages of both Lepidopteran pests, Cryptoblabes gnidiella and Prays citiri , reside in or adjacent to the rind of the fruit. However, these two pests create large entrance holes in the fruit that are easily detected during even a cursory inspection. This is not the case with the larvae of Medfly, which require a careful analysis of the fruit pulp because they feed inside the fruit and the oviposition entrance holes are usually not readily visible. The decision sheet also noted that, of the 20 plant pathogens or the 4 parasitic nematode pests identified, none are of quarantine significance. Furthermore, we also disagree with the commenter's claim that it is not possible to determine whether APHIS has selected the most appropriate management options to mitigate the identified pest risk, since our RMA is intended to evaluate the risk reduction potential of our approach. One commenter noted that the ORACBA analysis is not referenced in the RMA, and its conclusions and the conclusions used in the RMA are not the same. We agree that we did not cite the ORACBA document in the RMA, though we have done so in the October 4, 2002 revision. For the reasons discussed earlier in this document, we are confident that the ORACBA document supports the extension of cold treatment described in this rule, and that its findings provide support the conclusion that the revised treatment will provide the requisite probit 9 mortality assumed in the RMA. One commenter stated that the RMA should include a qualitative analysis that describes and characterizes the risk elements that are analyzed quantitatively. The commenter noted that, whereas the quantitative analysis allows for any variability, it does not capture the analyst's view of what the variability he/she believes might exist. We believe that the quantitative analysis captures the variability associated with the clementine pathway. Several of the steps that make up the pathway were evaluated using maximum, and therefore, most conservative, estimates. These conservative estimates isolate the conclusions of the RMA from the effects of variability. For example, the RMA assumed that the distribution of imported clementines in the United States would, over time, follow population demographic trends that suggest human population levels will increase in southern States where the risk of Medfly establishment is greater. This to say that the RMA assumes exaggerated current and near- term distribution of clementines to southern States, as it evaluates risk based on projected population levels in southern States that will not be realized until approximately 25 years from now. The RMA assumes that an additional 30 percent of clementines are shipped to those areas than is currently the case, to account for population trends assumed to occur in the future. The RMA also assumed that every shipment of clementines that arrives in a suitable location is equally likely to arrive in an area where suitable hosts for Medfly are present; however, during the fall and winter (when most clementines are shipped) this is a conservative assumption. By assuming conservative values, we were able to account for additional variability beyond that expressed explicitly in the RMA's simulation model (quantitative analysis). We would, however, like to note that a qualitative analysis of the risk of Medfly introduction into the United States is provided in the RMA under the heading “Likelihood of Introduction.” One commenter stated that using the likelihood of the movement of a single container of fruit to a susceptible grove as a means to assess the likelihood of successful invasion is uncharacteristic of Medfly invasion patterns. The commenter noted that clementines are imported for consumption, and historically, infestations have been detected in urban settings where a variety of residential plantings provide fruit year round. Thus, the commenter concluded that infestation of commercial production areas is most likely to occur via natural spread or artificial movement of infested fruit from a residential area to a commercial production area. We agree with the commenter and have revised our analysis such that it no longer assumes that an entire container is likely to be released into suitable conditions. Rather, we used evidence provided by Wearing et al. 2001 and Roberts et al. 1998 16 which suggests that a maximum of 5 percent of fruit that ends up in a given region is discarded. Since fruit that is not discarded is assumed to be consumed, we used the value suggested by Wearing et al. 2001 and Roberts et al. 1998 (the range provided was 0.5 percent to 5 percent) to estimate the actual amount of fruit that is not consumed and therefore, presents risks. Although we used the most conservative estimates (the maximum value for discards), our estimate of the overall probability of a mated pair in shipments was reduced. This is because, prior to consideration of this comment, the RMA's estimates treated all fruit as if it was not going to be consumed, and that all fruit, therefore, was likely to constitute hazards. This was clearly an overestimate, and the available evidence, as suggested by public comments, provided good reason for us to refine our estimates. 16 Wearing, C.H., J. Hansen, C. Whyte, C.E. Miller, J. Brown. 2001. “The potential for spread of codling moth (Lepidoptera: Tortricidae) via commercial sweet cherry fruit: a critical review and risk assessment.” Crop Protection 20: 465-488 and Roberts, R.C. Hale, T. van der Zwet, C. Miller, S. Redlin. 1998. “The potential for spread of Erwinia amylovora and fire blight via commercial apple fruit; a critical review and risk assessment.” Crop. Prot . 19-28. One commenter stated that the RMA's statistical calculations are incomplete, and fail to take into account more than one container of clementines. Consideration has not been given to additional shipments. The RMA estimated the risk associated with (1) a single shipment moving to suitable areas and (2) multiple shipments moving to suitable areas. The probability of a mated pair in a shipment of Spanish clementines arriving in a suitable area was estimated to be low. According to published evidence, 17 a shipment that includes a single container is already a conservative estimate of risk. Landolt et al. states: 17 Landolt, P., D. Chambers, and V. Chew. 1984. “Alternative to the use of probit 9 mortality as a criterion for quarantine treatments of fruit fly (Diptera: Tephritidae)-infested fruit.” J. Econ. Entomol 77: 285-287. “The most practical point to assess the risk of an introduction occurring is the probability of a potential mating pair or gravid female * * * getting through quarantine. A potential mated pair might be defined as a nonsterile male and a nonsterile female occurring in the same area during the same period such that mating is possible. For our purposes, a pair of fruit flies emerging from the same shipment would be considered a potential mated pair. The additional problems of survival, feeding, dispersal, mate finding and host finding are unknown but add a large degree of safety beyond the probability of a mated pair occurring. The risk of an introduction should then be calculated as the probability of one or more mated pairs per shipment surviving quarantine measures.” These statements clearly support our approach to using single shipments as the unit of risk. Nonetheless, the effects of multiple shipments (cited above) were still estimated using methods obtained from peer reviewed methodologies cited in the RMA. 18 18 Wearing, C.H., J. Hansen, C. Whyte, C.E. Miller, J. Brown. 2001. “The potential for spread of codling moth (Lepidoptera: Tortricidae) via commercial sweet cherry fruit: a critical review and risk assessment.” Crop Protecton 20: 465-488 and Whyte, C.F., R. Baker, J. Cowley, and D. Harte. 1996. “Pest establishment, a quantitative method for calculating the probability of pest establishment from imported plants and plant products, as a part of pest risk assessment.” NZ Plant Protection Centre Publications, No. 4, ISSN 1173-6704. Lynfield, NZ. One commenter stated that the calculation of the overall probability for a “mated pair” relies on a formula that combines the effects of many U.S. domestic shipments, but that formula uses as an input the probability for a mated pair in just a single shipment, whereas APHIS has already indicated that the probabilities differ for different shipments. The commenter claimed that the calculation cannot be correct if it just uses a single value, because that value does not represent all shipments, and therefore does not account for variability. Our calculations regarding the risk posed by a single shipment use the maximum risk posed by a single shipment, thus causing the figure to represent a worst-case scenario. For instance, we made assumptions regarding the Medfly populations in shipments that would be consistent with relatively high levels of infested fruit. Available evidence ( e.g. , Agusti, M. 2000. Citricultura. Ediciones Mundi-Prensa. Madrid, Spain. 416 pp. and Ministerio de Agricultura, Pesca y Alimentacion de Spain Trapping records) indicates that as fall arrives, the population levels of Medfly drop precipitously in Spain, thus making late season shipments much less likely to harbor Medfly than assumed by our baseline (maximum) value. Our approach has addressed some of the elements of variability as such via the use of maximum values, as discussed previously in this document. One commenter stated that, according to the RMA, the chances of live mated pairs of Medfly being introduced into the United States via every imported shipment going at the same time to the same suitable location is an unrealistic scenario. However, the commenter noted, it appears that the RMA calculates the probability for mated pairs of Medfly from any shipment going to any suitable location at any point in time, which is actually a fairly realistic scenario. Why did APHIS choose the scenarios it evaluated, and why did it not use real world scenarios? As stated earlier in this document, based on scientific research and published evidence, a single shipment is already a conservative unit for which to estimate risk. We estimated the likelihood that a mated pair of fruit flies would be present in a shipment (of 166,050 fruit) in the RMA. However, comments received from stakeholders on the draft RMA requested that we estimate alternative scenarios (for example, millions of fruit being deposited in close proximity such that flies from different shipments and shipped during different times would be assumed to find each other). These scenarios are clearly unrealistic, as the chance that the entirety of one shipping season's Spanish clementines going unconsumed, and ending up in close proximity to each other in a location that has available host material and the right environmental conditions is not likely. The figure calculated, does, however, provide an upper theoretical threshold. Analysts estimated these upper thresholds and noted that if there is a low probability of Medfly entry into a suitable area associated with extreme scenarios (such as those just described), then the probability of Medfly entry under more realistic, constrained scenarios is clearly lower. Nonetheless, again in response to [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A02-26668. Public record. Not legal advice.