# Importation of Grapefruit, Lemons, and Oranges From Argentina > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A00-14851 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** June 15, 2000 - **Citation:** 65 FR 37608 ## Text DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Parts 300 and 319 [Docket No. 97-110-5] RIN 0579-AA92 Importation of Grapefruit, Lemons, and Oranges From Argentina AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Final rule. SUMMARY: We are amending the citrus fruit regulations by recognizing a citrus-growing area within Argentina as being free from citrus canker. Surveys conducted by Argentine plant health authorities in that area of Argentina since 1992 have shown the area to be free from citrus canker, and Argentine authorities are enforcing restrictions designed to protect the area from the introduction of that disease. We are also amending the fruits and vegetables regulations to allow the importation of grapefruit, lemons, and oranges from the citrus canker-free area of Argentina under conditions designed to prevent the introduction into the United States of two other diseases of citrus, sweet orange scab and citrus black spot, and other plant pests. These changes will allow grapefruit, lemons, and oranges to be imported into the continental United States from Argentina subject to certain conditions. EFFECTIVE DATE: June 15, 2000. The incorporation by reference provided for by this rule is approved by the Director of the Federal Register as of June 15, 2000. FOR FURTHER INFORMATION CONTACT: Mr. Wayne D. Burnett, 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, referred to below as the fruits and vegetables regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests, including fruit flies, that are new to or not widely distributed within the United States. The regulations in “Subpart—Citrus Fruit” (7 CFR 319.28, referred to below as the citrus fruit regulations), restrict the importation of the fruit and peel of all genera, species, and varieties of the subfamilies Aurantioideae, Rutoideae, and Toddalioideae of the family Rutaceae into the United States from specified countries in order to prevent the introduction of citrus canker disease ( Xanthomonas campestris pv. citri (Hasse) Dye). The citrus fruit regulations also restrict the importation of the fruit and peel of all species and varieties of the genus Citrus into the United States from specified countries, including Argentina, in order to prevent the introduction of the citrus diseases sweet orange scab ( Elsinoe australis Bitanc. and Jenkins) and the B strain of citrus canker, which is referred to in the citrus fruit regulations as “Cancrosis B.” On August 12, 1998, we published a proposed rule in the Federal Register (63 FR 43117-43125, Docket No. 97-110-1) to amend the citrus fruit regulations by recognizing a citrus-growing area within Argentina as being free from citrus canker. In that document, we also proposed to amend the fruits and vegetables regulations to allow the importation of grapefruit, lemons, and oranges from the citrus canker-free area of Argentina under conditions designed to prevent the introduction into the United States of two other diseases of citrus, sweet orange scab and citrus black spot, and other plant pests. The proposed rule was followed by three notices regarding the comment period and public hearings for the proposed rule. Specifically, on October 16, 1998, we published in the Federal Register (63 FR 55559, Docket No. 97-110-2) a notice advising the public that we were extending the comment period for the proposed rule by 120 days and that we had scheduled a public hearing in Thousand Oaks, CA, to give interested persons the opportunity for the oral presentation of data, views, and arguments regarding the proposed rule. On December 4, 1998, we published in the Federal Register (63 FR 67011, Docket No. 97-110-3) a notice advising the public that we had changed the date and location of the public hearing in Thousand Oaks, CA. Finally, on January 13, 1999, we published in the Federal Register (64 FR 2151, Docket No. 97-110-4) a notice advising the public that we had scheduled an additional public hearing to be held in Orlando, FL. With the extension granted in the October 16, 1998, notice, we solicited comments for a total of 180 days ending on February 11, 1999. We received 332 comments by that date, including 63 comments received at the public hearings held in Orlando, FL, and Thousand Oaks, CA. The comments were from foreign and domestic producers, handlers, packers, and processors of citrus fruit; Members of the U.S. Congress and elected representatives of State and local governments; State plant protection officials and officials from Argentine's national plant protection organization, the Servicio Nacional de Sanidad y Calidad Agroalimentaria (SENASA); and representatives of the U.S. Citrus Science Council (USCSC), a group formed specifically to respond to the proposed rule. Seventeen of the comments were letters requesting that we extend the comment period for the proposed rule, and 3 comments simply stated that any decision should be based on sound science. Two hundred and fifty comments, 148 of which were form letters offering support for the position of the USCSC, raised concerns or made suggestions regarding the proposed rule. Those comments are addressed in detail later in this document. The remaining 62 comments offered support for the proposed rule as it was written. Those commenters who supported the proposed rule noted the mutual benefits of trade, recognized the scientific basis of the proposed rule, stated that Argentine imports would provide competition for citrus imports from other countries, saw an opportunity to increase citrus exports to Argentina, noted that Argentine citrus has been exported to markets in other countries—including citrus-producing countries—without incident, and noted the positive economic effects that Argentine citrus imports would have on consumers, wholesalers, distributors, and ports of entry. The comments that we received in opposition to the proposed rule focused largely on the scientific basis and support for the proposed mitigation measures and on the execution and conclusions of the risk assessment that was used by the Animal and Plant Health Inspection Service (APHIS) in reaching the decision to initiate the proposed rule. These comments, as well as the numerous comments that we received on other particular aspects of the proposed rule and its supporting documentation, are reported and addressed in this final rule. With regard to the proposed mitigation measures, several commenters questioned whether the systems approach to phytosanitary security explained in the proposed rule would provide an adequate measure of protection against the introduction of the diseases and insect pests of concern, especially given their understanding that APHIS had never before used a systems approach to mitigate the risks presented by a pest complex that included both insects and pathogens. Other commenters questioned the volume, adequacy, and accuracy of the scientific data provided by Argentina to support the efficacy of the proposed mitigation measures contained in the systems approach. As we discuss in detail below in response to specific comments, we believe that the information furnished by Argentina, when considered in conjunction with the body of information available in the scientific literature regarding the insects and diseases of concern, provides the necessary rational basis for our determination that individual and cumulative mitigative effects of the systems approach serve to reduce the risks presented by Argentine grapefruit, lemons, and oranges produced and imported in accordance with this rule to a negligible level. With regard to the pest risk assessment prepared by APHIS, several commenters disagreed with the manner in which we prepared the risk assessment, questioning basic choices made by the risk assessors concerning issues such as independence in the model and our use of a shipping box as the risk unit. Other commenters questioned whether APHIS offered sufficient justification for the estimates used in section II.8 (Likelihood of Introduction) of the risk assessment. In this final rule, we discuss, in our responses to specific comments on these and other related issues, the manner in which we prepared the risk assessment and how we arrived at our estimates. Our experience in examining the risks presented by agricultural commodities produced around the world has led us to select the model that we used as the framework for estimating those risks. This model has proven itself over the years and for several commodity/pest combinations to be an efficient means of estimating phytosanitary risk, and we (and others, including the Harvard Center for Risk Analysis) believe our guidelines are valid. While we acknowledge that there are alternative ways of estimating this type of risk, we do not believe that using a different model would result in a substantively different outcome. Distribution Limitations In the proposed rule, we discussed the importation of grapefruit, lemons, and oranges into the entire United States. However, the risk assessment that was prepared prior to the preparation of the proposed rule only examined the risks presented by the importation of that fruit into the continental United States (the 48 contiguous States, Alaska, and the District of Columbia). Although we have no reason to believe that the risk associated with importing Argentine citrus into Hawaii, Guam, the Northern Mariana Islands, Puerto Rico, or the U.S. Virgin Islands would differ in any significant way from the risks associated with the importation of that fruit into the continental United States, the fact remains that the risk assessment did not consider the risks associated with the importation of Argentine citrus into destinations outside the continental United States. Therefore, in this final rule we have narrowed the area into which the grapefruit, lemons, and oranges may be imported by limiting the distribution of the fruit to the continental United States. If we were requested to do so by Argentina or other interested parties, we would undertake to assess the risks associated with the entry of Argentine citrus into areas outside the continental United States and initiate rulemaking to provide for the entry of the fruit into those additional areas if our risk assessment supported such an action. We continue to have confidence in the efficacy of the systems approach for Argentine citrus and in the conclusions of our pest risk assessment, which found that the risk presented by grapefruit, lemons, and oranges imported in accordance with that systems approach is negligible. However, in response to comments from the domestic citrus industry and others voicing concern over the use of a systems approach in a situation where both diseases and insect pests exist in a foreign production area, we will institute a limited distribution plan that will delay the entry of Argentine citrus into citrus-producing areas in the continental United States until 2004. This delay will provide an opportunity for the efficacy of the systems approach to be demonstrated under actual production and distribution conditions before Argentine citrus imports are allowed to enter citrus-producing areas of the continental United States. The limited distribution plan would involve a three-stage phase-in of Argentine citrus imports: • Stage 1 (the 2000 and 2001 shipping seasons). Upon the effective date of this final rule, fruit that meets the requirements of the export program will be eligible for entry into 34 States in the continental United States that are neither buffer States nor commercial citrus-producing States. • Stage 2 (the 2002 and 2003 shipping seasons). When Argentina begins shipping fruit in May or June of 2002, the fruit will be eligible for entry into the 34 “Stage 1” States as well as the 10 buffer States (Alabama, Arkansas, Colorado, Georgia, Mississippi, Nevada, New Mexico, Oklahoma, Oregon, and Utah) that share borders with one or more commercial citrus-producing States, leaving only 5 commercial citrus-producing States (Arizona, California, Florida, Louisiana, and Texas) as prohibited destinations in the continental United States. • Stage 3 (the 2004 shipping season). When Argentina begins shipping fruit in May or June of 2004, the fruit will be eligible for entry into all areas of the continental United States. These “rolling effective dates” are built into the final rule, which precludes the need for APHIS to initiate rulemaking in 2002 and 2004 to expand the area into which the fruit may be imported. If it is determined that the requirements of the export program are not being observed routinely or uniformly, APHIS will be able to act quickly to suspend the rolling effective dates or even the entire program, if warranted. The export program provides for the detection of diseased fruit at any point in the pathway, with that detection leading to the rejection of the shipment containing the diseased fruit and the removal of the grove that produced the fruit from the export program for the remainder of the shipping season. Thus, the detection of diseased fruit will not, by itself, result in the suspension of all or part of the export program. To determine whether the requirements of the export program are being observed routinely or uniformly and to ensure that the distribution restrictions of this rule are being observed, APHIS personnel will be involved in monitoring activities in both the United States and Argentina: Monitoring—United States. To help ensure that importers and distributors of Argentine citrus are aware of the distribution limitations of this rule, those limitations will be included as one of the conditions of the permit that importers must obtain in order to import grapefruit, lemons, or oranges from Argentina. APHIS personnel, as well as personnel with State regulatory agencies and the Department's Agricultural Marketing Service, will be enlisted to enforce the distribution limitations of the rule. This will be accomplished through market visits, inspections, and outreach efforts directed at importers, shippers, distributors, and retailers. The infrastructure needed to support these efforts is already in place. Monitoring Argentina. The rule does not require direct APHIS involvement in the supervision of the export program in Argentina; that direct supervision is the responsibility of SENASA, Argentina's national plant protection organization, which is regarded by APHIS (and internationally) as an efficient and capable organization. A recent (April 24 to 28, 2000) site visit to citrus groves and packinghouses in Argentina by APHIS bears out this perception. In order to evaluate whether it is appropriate to allow each stage of the phased-in distribution plan to occur as scheduled, and to provide for the ongoing evaluation of the export program, APHIS will be conducting inspection visits to the Argentine production area and will maintain contact with SENASA throughout each year to monitor their administration of the export program. Further, APHIS and SENASA are currently finalizing the details of the annual operational work plan that will address the administration of the program during the current season and that will serve as the basis for future annual work plans. That work plan will include provisions for active and direct monitoring of the export program by APHIS personnel who will conduct frequent oversight visits to the growing areas and packinghouses. APHIS' monitoring activities will include: • Inspections of groves following the removal of leaves and other litter, • Review of the timing and application of fungicidal sprays, • Accompanying SENASA inspectors as they conduct preharvest grove inspections and collect samples of fruit for laboratory examination, • Visits to the SENASA-approved laboratories that will be examining the sampled fruit to review the procedures for, and results of, the fruit incubation protocol, • Observing the harvesting of fruit, its transport to the packinghouses, and the entry control systems in place at the packinghouses, and • Ensuring that the required handling, treatment, inspection, identification, and packing requirements of this rule are being observed in the packinghouses. These monitoring activities carried out by APHIS and SENASA personnel will provide us with a clear confirmation of the practicability of the systems approach under actual production conditions, its efficacy in preventing disease in export groves, and the ability of the required inspections and laboratory examinations to detect diseased fruit. Additional evidence of the success or failure of the export program will be gained through the inspections that will be conducted at U.S. ports of entry following the arrival of the fruit and the application of any required cold treatments. Should APHIS, as a result of these activities or any other assessments of the program, conclude that the requirements of the export program are not being observed uniformly and routinely, the program will be reviewed; should APHIS determine that there are deficiencies in the program that cannot be remedied, the phased-in expansion of distribution, or even the export program itself, may then be suspended or terminated. Specific Regulatory Changes Regarding Limited Distribution To implement the limited distribution plan, we have made several changes to this final rule. These changes are explained below and pertain to the distribution limitations themselves, box marking, stickering, and ports of entry. Limitations on Distribution. We have added a new § 319.56-2f(g) to this final rule to incorporate the distribution limitations into the requirements of the rule. That paragraph states that the distribution of the grapefruit, lemons, and oranges is limited to the continental United States (the 48 contiguous States, Alaska, and the District of Columbia.). That paragraph also states that during the 2000 through 2003 shipping seasons, the distribution of the grapefruit, lemons, and oranges is further limited as follows: • During the 2000 and 2001 shipping seasons, the fruit may be distributed in all areas of the continental United States except Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Louisiana, Mississippi, Nevada, New Mexico, Oklahoma, Oregon, Texas, and Utah. • During the 2002 and 2003 shipping seasons, the fruit may be distributed in all areas of the continental United States except Arizona, California, Florida, Louisiana, and Texas. For the 2004 shipping season and beyond, the fruit may be distributed in all areas of the continental United States. Box Marking As was presented in the proposed rule, § 319.56-2f(c)(6) of this final rule requires the boxes in which the fruit is packed to be marked with the SENASA registration number of the grove that produced the fruit. This final rule requires that the boxes also be marked with a statement indicating that the fruit may not be distributed in Hawaii, Guam, the Northern Mariana Islands, Puerto Rico the U.S. Virgin Islands ( i.e., destinations outside the continental United States), or in any State (each of which must be individually listed) into which the distribution of the fruit is prohibited under the limited distribution plan. To account for the possibility that the fruit might have to be repackaged following its entry into the United States, new paragraph § 319.56-2f(i) states that any new boxes in which the fruit is packed must also be marked with the limited distribution statement required under § 319.56-2f(c)(6). Stickering APHIS has found that the marking of individual fruit is necessary for the limited distribution scheme to be enforceable; otherwise it would be difficult to distinguish Argentine grapefruit, lemons, or oranges from domestically produced fruit or fruit imported from other sources. Therefore, we have amended § 319.56-2f(c)(5) in this final rule to require that the grapefruit, lemons, and oranges be individually labeled with a sticker that identifies the packinghouse in which they were packed. We understand that Argentina's citrus producers routinely label their fruit with stickers identifying the packinghouses in which the fruit was prepared for distribution, and we believe that those packinghouse labels would serve to adequately identify the fruit since we would be able to provide examples of each packinghouse's sticker to our inspectors and cooperators. Therefore, we do not believe that this stickering requirement will impose a significant additional burden on Argentine growers, packers, or exporters. Ports of Entry New § 319.56-2f(h) states that the grapefruit, lemons, and oranges may enter the United States only through a port of entry located in a State where the distribution of the fruit is authorized under § 319.56-2f(g), which, as explained above, is the section of the regulations that provides for the limitations on the distribution of the fruit. The port-of-entry restrictions of § 319.56-2f(h) apply to both the limited distribution plan's staged phase-in of imports into the continental United States and the prohibition on the distribution of the fruit outside the continental United States. As noted above, we believe that this limited distribution plan will provide an opportunity for the efficacy of the systems approach to be demonstrated under actual production and distribution conditions before Argentine citrus imports are allowed to enter citrus-producing areas of the continental United States. Miscellaneous Comments Comment: In 1995, APHIS denied Argentina's petition to export citrus to the United States due to the risks that were posed by the fruit. The proposed rule does not set forth the information and experimentation that transpired between 1995 and 1996 that led APHIS to reverse its position. It is only appropriate that the U.S. citrus industry have the opportunity to evaluate the basis for APHIS' decision to reverse its position. Response: In our proposed rules, we usually focus on describing and justifying the specific regulatory changes or additions that we are proposing, so we do not routinely provide the sorts of historical or evolutionary details that the commenter mentions. In the case of the Argentine citrus proposed rule, we concentrated on explaining the proposed citrus export program set forth in the regulatory text of the proposed rule; we did not believe it was necessary to examine the differences between that program and any earlier Argentine petitions that we had rejected. However, the process of data gathering, experimentation, and negotiation that led to the proposed rule is documented in the material contained in the rulemaking record, and we provided that material to several interested parties who requested it, including representatives of the U.S. citrus industry. Comment: Two documents in the rulemaking record—a trip report prepared after APHIS’ 1994 trip to northwestern Argentina and a memorandum dated May 27, 1994, that discusses the status of Argentina's request to export citrus both raise questions and concerns regarding the Argentine petition. The May 1994 memorandum recommended two actions: (1) That the Government of Argentina request a thorough risk assessment be completed, and (2) that an expert group of pathologists from APHIS and the Agricultural Research Service determine what research was needed before a regulatory decision was made, establish tolerances for diseased fruit in an export program and how these can be measured, and make an assessment of Argentina's citrus canker survey. While the call for a risk assessment in point number one may have been addressed by APHIS’ original 1995 risk assessment, the recommendations on point number two appear to have gone unaddressed. We believe that all those questions must be answered before APHIS takes any further action on Argentina's petition. To that end, the proposed rule should be withdrawn to allow for a full scientific discussion of the questions found in those documents. Response: Both of the actions recommended in the May 1994 memorandum were completed prior to the development of the proposed rule. As noted by the commenter, APHIS did prepare a preliminary qualitative pest risk assessment in 1995, and that 1995 assessment was followed up by the 1997 quantitative pest risk assessment used as support for the proposed rule. In September 1994, our expert group of pathologists identified to Argentina the areas in which we believed additional research was needed and requested another year's worth of data to substantiate their proposed mitigation measures; that data was received in the spring of 1996. Further, as evidenced by the provisions of the proposed rule and this final rule, we established tolerances for diseased fruit in the export program ( i.e., the detection of a single diseased fruit will result in the grove in which the fruit was grown being removed from the export program, and the fruit from that grove being prohibited entry into the United States, for the remainder of that year's growing and harvest season). We have also included inspection provisions to detect diseased fruit and prevent its entry into the United States. Finally, we completed our review of Argentina's citrus canker survey program and have full confidence in the efficacy of its methodology and the accuracy of its findings. Given that all the issues raised in the May 1994 memorandum were addressed prior to the preparation of the proposed rule, we do not believe it is necessary to withdraw the proposed rule for the reasons stated by the commenter. Comment: In 1994, Argentina proposed a systems approach to suppress citrus black spot and sweet orange scab that was based on individual farms performing the suppression treatment. At the time, APHIS stated that individual farms were too small a unit for sufficient disease suppression and that a larger area with clearly defined geographic boundaries encompassing all citrus grown in the region would be necessary. Why is APHIS now proposing a system based on individual farms performing the suppression treatment? Response: The original Argentine proposal did not include several of the aspects of the systems approach required by this rule, such as the preharvest surveys, laboratory analysis of sampled fruit, and post-harvest treatments. When those aspects of the systems approach were included in later proposals and data were made available to support their efficacy, we concluded that a grove-level approach to the plant pests of concern would be appropriate. Comment: The 1994 trip report posits that one possible step that could be taken in order to permit Argentine citrus to enter the United States would be to limit exports to Northeastern ports. A limited distribution requirement similar to the restrictions on the importation of avocados from Mexico would not be a sufficient or enforceable mitigation measure for Argentine citrus. If the market provides an economic reason to ship the citrus to other States, parties with an economic motivation to do so will find a way to make that happen. It is not realistic to say that APHIS has sufficient resources to “police” this requirement. The result would be the spread of devastating diseases to citrus growing regions. Indeed, APHIS has had recent experience in dealing with illegal shipments of Mexican avocados by a large retailer. Once Argentine citrus enters the United States, it must be assumed that the fruit will reach every market in the continental United States. Thus, any potential restriction on where the fruit can be shipped is unrealistic. Response: That suggestion was indeed offered during discussions that preceded the preparation of the proposed rule, but the proposed rule did not include limitations on distribution. This final rule does, however, limit the importation of the fruit to the continental United States and incorporates a three-stage phase-in of imports that limits the distribution of the fruit during the 2000 through 2003 shipping seasons. These aspects of this final rule are explained above under the heading “Distribution Limitations.” As noted in that section, we continue to have faith in the efficacy of the systems approach and in the findings of the risk assessment, thus we continue to believe that citrus fruit imported from Argentina in accordance with this rule presents a negligible risk of introducing diseases or insect pests into any area of the continental United States. APHIS personnel, as well as personnel with State regulatory agencies and the Department's Agricultural Marketing Service, will be enlisted to enforce the distribution limitations of the rule. This will be accomplished through market visits, inspections, and outreach efforts directed at importers, shippers, distributors, and retailers, and the infrastructure and resources needed to support these efforts are already in place. Given the experience we have gained through the Mexican avocado program and through the implementation of our expanded smuggling interdiction program, we believe that we have the ability to enforce the distribution restrictions of this rule. Comment: We requested a 1-year extension of the comment period for the proposed rule, then shortened the requested length of the extension to 6 months. By granting only a 4-month comment period extension and subsequently denying our request for a 2-month postponement of the scheduled public hearing, APHIS has denied the affected public a fair opportunity to comment on the proposed rule. Response: With the original 60-day comment period and the 120-day extension noted by the commenter, the proposed rule was open for public comment from August 12, 1998, through February 11, 1999, a total of 6 months. We believe that this 180-day comment period afforded the affected public a fair opportunity to comment on the proposed rule. Further, in denying the commenter's request for a 2-month postponement of the California public hearing, which we had already postponed once, the Department made it clear that it was willing to review any new information that might surface following the close of the comment period. Specifically, the APHIS hearing officer at the Thousand Oaks, CA, hearing—which was attended by the commenter—read the following statement from Deputy Secretary Richard Rominger: “Following the close of the comment period, we will thoroughly analyze and review the available material and all comments in the record to determine how best to proceed in the rulemaking process. However, if any new scientific information comes to light after the close of the comment period on February 11, 1999, which has a material and significant bearing on this rulemaking proceeding, such information will be thoroughly considered by the Department, and the Department will take such further action as is appropriate.” Comment: We informed APHIS on October 2, 1998, that our group was organizing to comment on the proposed rule and had selected a delegation of university scientists from California, Texas, and Florida to travel to Argentina in order to gather information. By failing to provide timely assistance to our group in arranging that trip, APHIS has denied our group and other interested parties a meaningful opportunity to conduct critical scientific analysis. Response: We believe that the correspondence exchanged between APHIS and the commenter concerning a site visit indicates that APHIS cooperated with the commenter's group in its efforts to arrange a visit to Argentina: • After receiving the commenter's letter dated October 2, 1998, APHIS informed the Argentine Ministry of Agriculture of the commenter's desire for a site visit by university scientists. Argentine officials responded by requesting APHIS' endorsement of the visit prior to granting their consent for a site visit. • In a letter dated November 6, 1998, APHIS informed the commenter of Argentina's response. In that letter, we stated that we were prepared to endorse the visit and asked for a specific description of its objectives so that we could pass that information along to Argentina. • In a letter dated December 1, 1998, the commenter responded with the requested information and indicated its eagerness to work with APHIS to arrange the trip. • In a letter dated December 7, 1998, we informed the commenter that we would endorse the visit and attempt to arrange a visit in the second week of January 1999. • In a letter dated December 17, 1998, the commenter rejected the idea of a January visit, stating that the notice was too short and that January was not a “biologically relevant” time for a visit. In that letter, the commenter's group informed APHIS that it wished to make a visit in April or May, and perhaps make another visit in July or August. • No further progress was made on the issue of a site visit following that December 17, 1998, letter. In subsequent correspondence, the commenter's group informed us that they would attempt to ensure that the comment period was extended or the record otherwise held open in order to provide for APHIS' consideration of any information collected during possible future site visits by their scientists. We believe that the timeline provided above shows that APHIS did in fact provide timely assistance to the commenter, and we disagree with the commenter's assertion that APHIS denied interested parties a meaningful opportunity to conduct critical scientific analysis. Comment: On September 22, 1998, we filed a Freedom of Information Act (FOIA) request with APHIS in which we asked for any background materials and correspondence relating to the 1997 risk assessment. APHIS' FOIA office acknowledged that request on September 29, 1998, but did not provide any material or acknowledge our follow-up request before the end of the comment period. APHIS has, therefore, withheld or failed to disclose relevant information that would allow the public to interpret and understand the findings in the risk assessment. Response: Due to our FOIA staff's large workload, we were unable to fulfill the commenter's FOIA request before the February 11, 1999, close of the comment period. However, we did forward the requested documents to the commenter shortly after the close of the comment period. As indicated in the response to a previous comment, we informed the commenter prior to the close of the comment period that we are willing to thoroughly consider, and address as appropriate, any new scientific information that comes to light that has a material and significant bearing on this rulemaking proceeding. Comment: At the February 5, 1999, public hearing, a member of the APHIS panel stated that APHIS was relying on a 1986 Plant Protection and Quarantine (PPQ) study to support its position that it was highly unlikely that citrus black spot would become established by the spores produced on infected fruit. We believe that APHIS is using this PPQ study as the pivotal foundation for the proposed rule. APHIS' failure to disclose its reliance on this pivotal 1986 study until extremely late in the proposed rule's comment period is a violation of proper administrative procedures. APHIS has denied the affected public the opportunity to comment on the Agency's rationale for the proposal; the lack of disclosure of this one study, in and of itself, is a compelling reason why this proposal must be withdrawn by APHIS. Response: APHIS did not use the cited 1986 study as “the pivotal foundation for the proposed rule.” Most of the APHIS employees involved in the preparation of the proposed rule were either unaware of or had forgotten the 1986 study. It was not until the panel that represented APHIS at the two public hearings was preparing for the February 5, 1999, hearing in Orlando, FL, that one of the panel members recalled the existence of that study; this was more than 5 months after the proposed rule was published. Further, the official transcript of the February 5, 1999, hearing indicates that the APHIS panel member simply quoted from the 1986 study; she did not state that APHIS was “relying on” the study. Because we did not rely on the study or its findings in the preparation of the proposed rule, we do not believe the fact that it was not mentioned until late in the comment period is grounds for the withdrawal of the proposed rule. Comment: APHIS did not comply with its obligations under Executive Order 12866 in developing the proposed rule. In particular, section 6(a) of the Executive Order provides that each agency should engage the impacted public with an opportunity for informal dialogue prior to issuing a proposed rule. For this reason alone, APHIS should withdraw the proposed rule to permit the required consultations to begin. Response: The portion of the executive order cited by the commenter reads in part: “Each agency shall (consistent with its own rules, regulations, or procedures) provide the public with meaningful participation in the regulatory process. In particular, before issuing a notice of proposed rulemaking, each agency should, where appropriate, seek the involvement of those who are intended to benefit from and those expected to be burdened by a regulation.” Consistent with our standard procedures, APHIS did in fact informally contact representatives of the domestic citrus industry regarding the Argentine proposal in October 1997, and indications at that time were that the domestic citrus industry supported the concept of Argentine citrus imports. Further, a new pest list based on the 1995 risk assessment and updated with information provided by Argentina was sent for comment to the State plant regulatory officials (SPRO's) in the citrus-producing States of Florida, Louisiana, Texas, Arizona, and California in the fall of 1996, and a draft of the 1997 quantitative pest risk assessment was sent to those SPRO's in the spring of 1997. Each of the SPRO's was encouraged by APHIS to circulate those documents as they saw fit. We do not believe, therefore, that the proposed rule must be withdrawn in order to comply with Executive Order 12866. Comment: If APHIS allows Argentine citrus to enter the United States without adequate protective measures in place, and the U.S. citrus industry is then economically injured, APHIS' actions would rise to the level of a “taking” of private property by an arm of the U.S. Government. Response: Because this rule places no limitations or restrictions whatsoever on the U.S. citrus industry or individual U.S. growers or their property, we do not believe that this rule constitutes a regulatory taking. Comment: In failing to establish quarantine-level treatments for citrus black spot and sweet orange scab in the proposed rule, APHIS is failing to meet its responsibilities for pest exclusion under the Plant Quarantine Act and the Federal Plant Pest Act, which clearly charge the Secretary of Agriculture with the responsibility for preventing the entry of pests that are new to or not widely established in the United States. Response: Neither the Plant Quarantine Act nor the Federal Plant Pest Act state that quarantine-level treatments are the only means through which the Secretary may meet his responsibilities for pest exclusion under those acts. Rather, 106 of the Federal Plant Pest Act (7 U.S.C. 150ee) authorizes the Secretary to promulgate regulations requiring the inspection of articles imported into the United States and may impose “other conditions upon such movement, as he deems necessary to prevent the dissemination into the United States, or interstate, of plant pests * * *.” Quarantine-level treatments are not available for all commodity/pest combinations; in the absence of such treatments, we must consider whether alternative measures are available that will provide a comparable level of quarantine security, and we expect other nations to do the same with respect to U.S. agricultural exports. In this rule, we require the use of tiered and overlapping measures that, when combined with specified cold treatments or host resistance, will reduce the pest risks associated with the importation of Argentine citrus to a negligible level. We believe, therefore, that we have met our responsibilities under the acts cited by the commenter. Comment: APHIS' fruits and vegetables regulations only address the importation of fruits and vegetables from countries where insect pests are present; diseases are not addressed. It appears that APHIS does not have the authority under its regulations to permit the entry of fruits or vegetables from countries where one or more diseases exist. Therefore, given that citrus diseases exist in Argentina, it appears that APHIS does not have the authority under its regulations to promulgate a regulation that allows the importation of grapefruit, lemons, and oranges from that country. Response: Our regulations are not the source of our authority to regulate the importation of fruits and vegetables; rather, they are a means through which we exercise the authority derived from statutes such as the Federal Plant Pest Act and the Plant Quarantine Act. The Secretary of Agriculture is provided with the authority in the Plant Quarantine Act to restrict the importation of fruits and vegetables because of “injurious plant diseases or insect pests” or to prohibit such importation because of any “disease or of any injurious insect” (7 U.S.C. 159, 160). Therefore, we have clear statutory authority to regulate the importation of fruits and vegetables because of diseases as well as insect pests. With respect to our regulations implementing the Secretary's authority under those acts, the commenter is correct in noting that the fruits and vegetables regulations contain no general provisions regarding diseases. However, the regulations in “Subpart—Citrus Fruit” (§ 319.28), which we are amending in this rule and which was discussed in the proposed rule, do in fact contain specific restrictions on the importation of fruit of citrus and citrus relatives from specified countries due to the presence of citrus diseases in those countries. Comment: The April 1992 pest risk analysis that APHIS completed for its rulemaking regarding the importation of citrus from South Africa states that “[i]mportation of all plant parts, except seed, of Citrus spp. should be prohibited from countries where the disease [black spot] occurs” (Pest Data Sheet on Black Spot of Citrus, p. 62). Yet, neither the risk assessment nor the proposed rule for Argentine citrus mentions that serious concern that the Agency had so recently expressed about citrus black spot. It appears that APHIS is now proposing to make an abrupt change in its position regarding this disease and the danger that it poses without either articulating the reasons for this change or including in the record substantial evidence that could support such a divergence from longstanding agency policy. Response: We disagree with the commenter's contention that we are making an abrupt change in policy with regard to the risks presented by citrus black spot. More importantly, our position regarding the phytosanitary significance of citrus black spot has not changed as drastically as the commenter suggests. We still consider citrus nursery stock and plant parts other than fruit to pose a high risk as pathways for the introduction of citrus black spot. It is only our position relative to citrus fruit—specifically, citrus fruit that has been subjected to the measures required by this rule—that has changed since the April 1992 pest risk analysis for South African citrus. The pest data sheet cited by the commenter was completed more than 5 years before we prepared the Argentine citrus analysis and did not consider the tiered and overlapping measures used in the systems approach to mitigate the risk of citrus black spot; thus, the data sheet's recommendations were made in the context of an importation scenario in which no measures short of prohibition were offered to mitigate the risk of citrus black spot. APHIS' reading of the relative risks presented by citrus plants, fruit, and other plant parts is consistent with the current research into the epidemiology and control of citrus black spot and the evolving scientific understanding of the disease. For example, Professor J.M. Kotze of the University of Pretoria (South Africa) reports in a Department of Microbiology and Plant Pathology summary of plant pathology research focus areas that: “We have shown that the disease [citrus black spot] spreads to new areas through leaves of nursery trees. The importance of the inoculum sources was already demonstrated, especially the fact that fruit presents no danger to importers of citrus in Europe.” Fruit has been shown to be a poor pathway for the introduction of citrus black spot, and, as explained in the proposed rule, the required systems approach acts to reduce any remaining risk to a negligible level. Trade-Related Issues Comment: In the proposed rule, APHIS stated: “Maintaining a prohibition on the importation of grapefruit, lemons, and oranges from the Argentine States of Catamarca, Jujuy, Salta, and Tucuman in light of those State's [sic] demonstrated freedom from citrus canker would run counter to the United States' obligations under international trade agreements and would likely be challenged through the World Trade Organization” (WTO). This is simply not true. Even if the four involved Argentine States are free from citrus canker, there are other potentially devastating citrus diseases and pests present. Under the Uruguay Round WTO agreement, the United States has no obligation to permit the introduction and spread of quarantine diseases and pests in this country. Any country is free to adopt a “zero risk” standard as its appropriate level of protection; we submit that the current U.S. prohibition on fruit that is infected with sweet orange scab and citrus black spot is entirely consistent with the Uruguay Round's “Agreement on the Application of Sanitary and Phytosanitary Measures” (the “S&P Agreement”). Argentina has not shown that the importation of fruit from an indisputably infected region poses no risk that sweet orange scab, citrus black spot, or both, may be introduced into the United States. Response: We understand that we are not required to allow diseased or infested fruit to be imported into the United States; indeed, this rule does nothing to alter the “current U.S. prohibition on fruit that is infected with sweet orange scab and citrus black spot” noted by the commenter. However, we also recognize that we are obliged to use health requirements only to the extent necessary to meet our “appropriate level of protection.” In the case of grapefruit, lemons, and oranges from Argentina, we believe that the tiered and overlapping safeguards contained in this final rule will reduce the pest risk associated with their importation to a negligible level. If the United States had deemed “zero risk” to be its appropriate level of protection, then it is unlikely that Argentine citrus—and many other commodities, for that matter—would ever be approved for importation into the United States. There will always be some degree of pest risk associated with the movement of agricultural products; APHIS' goal is to reduce that risk to a negligible level. While the one sentence quoted by the commenter from the proposed rule mentioned only citrus canker, we believe that it is evident from the content of the entire proposed rule that we did indeed consider the presence of other diseases and insect pests in Argentina. It should be noted that the sentence quoted by the commenter was preceded by another sentence in the proposed rule: “We have rejected that alternative [ i.e., to make no changes in the regulations and continue to prohibit the importation of grapefruit, lemons, and oranges from Argentina] because we believe that Argentina has demonstrated that the citrus-growing areas of the States of Catamarca, Jujuy, Salta, and Tucuman are free from citrus canker and because we believe that the systems approach offered by Argentina to prevent the introduction of other plant pests reduces the risks posed by the importation of grapefruit, lemons, and oranges to a negligible level.” Comment: We submit that APHIS should consult with the U.S. Congress on the issue of the “appropriate level of protection” in this situation, especially given that the world trading community has yet to settle the issue of what constitutes an appropriate level of protection. The citrus industry is far too important to the United States economy and trade interests for APHIS to make critical economic and foreign policy decisions on its own, particularly when no international standard dictates a particular result. Response: The provisions of the WTO SPS Agreement provide that it is the sovereign right of each member to set its own level of protection, thus it would be inappropriate for the “world trading community” to make such a determination. In this instance, APHIS, as the recognized regulatory authority, is establishing a system of phytosanitary measures that reflect the level of protection deemed appropriate. It is our intent to allow fresh grapefruit, lemons, and oranges to be imported into the continental United States from Argentina only if they are grown, packed, and shipped under specified phytosanitary conditions designed to mitigate the risk of plant pest introduction. We are confident that the phytosanitary measures required by this rule will mitigate the risk presented by Argentine citrus. Given that confidence, we do not believe that the level of protection afforded by this rule is a departure from the level of protection we demand in other commodity import situations. Comment: Article 6 of the S&P Agreement recognizes that countries can have regions that are pest- or disease-free or have areas of low pest or disease prevalence. However, it is envisioned that each country claiming to have such regions has the burden of proving that such areas have no pests or diseases or have low levels of pests or disease. Argentina has not provided any information to APHIS as to the levels of pests or diseases that are present in the four States that are proposed for export. Response: Argentina claims that the citrus-growing regions identified in this rule are free from citrus canker, and we believe that they have provided sufficient documentation to support that claim. We also believe that Argentina submitted sufficient documentation to support its position that the remaining pests and diseases were of low enough prevalence that the chemical, cultural, and other controls of the systems approach would prevent their introduction into the United States on fruit imported under the requirements of this rule. Comment: APHIS' regulations in § 319.56-2 refer to “without risk,” yet the proposed rule seems to have a standard on “negligible risk.” Even if APHIS does have the statutory authority to adopt a “negligible risk” standard, the standard is undefined and impossible to determine. This is not acceptable. The standard should be capable of being independently validated and should be set only after rigorous peer review, in accord with standards and guidelines adopted by WTO with the advice of International Plant Protection Convention (IPPC). Response: The “without risk” provision selected by the commenter is found in § 319.56-2(e) and is used in the context of importing a fruit or vegetable from a definite area or district of a country that is free from some or all of the injurious insects that attack the fruit or vegetable when that area or district meets the criteria for pest freedom found in § 319.56-2(f). Section 319.56-2(e) is not applicable to this rulemaking because the Argentine Government has made no claims with regard to the freedom of northwestern Argentina with regard to injurious insects i.e. , fruit flies in this case. The risk of diseases is addressed under the regulations in § 319.28 (Subpart—Citrus Fruit), which contains no such “without risk” standard. In any event, we do not believe that a policy of requiring imports to be “without risk” or to present “zero risk” could be sustained by any country that wishes to engage in international trade. There will always be some degree of pest risk associated with the movement of agricultural products; APHIS' goal is, and always has been, to reduce that risk to a negligible level. This goal is entirely consistent with the standards and guidelines of the WTO and the IPPC. Comment: In the proposed rule, APHIS does not offer any “reasoned analysis” for departing from its longstanding policy of not permitting the importation of fruit from diseased regions. In its two recent rulemakings regarding the importation of citrus from South Africa and Australia, APHIS stated that it would deny the entry of citrus from each of those countries if the citrus was found to be infected with citrus black spot. It appears that it was clear to APHIS in those cases that citrus black spot was so troubling and dangerous that the only way to protect the United States against importation of this disease was to disallow the importation of any fruit from diseased areas. The inconsistency of APHIS' proposed approach to Argentine fruit with its prior, recent positions regarding fruit from South Africa and Australia is never mentioned or explained in the proposed rule or the risk assessment. Further, the differences in the approaches applied to Argentine citrus on one hand, and Australian and South African citrus on the other, leaves the United States open to challenges from Australia and South Africa under article 2.3 of the S&P Agreement, which requires that member countries do not discriminate with respect to other member countries where “similar conditions prevail.” Response: In the two rulemakings cited by the commenter regarding the importation of citrus from Australia and South Africa, the freedom of the production areas from citrus black spot formed part of the basis for allowing the importation of citrus from those countries. Because the importation protocols were based largely on that area freedom, it follows that we would prohibit the importation of citrus from either country if it was found to be infected with citrus black spot. In the case of Argentine citrus, no such claim of area freedom is made, which is why this rule requires control and detection measures for citrus black spot. Because of these differences in the bases for the three rules in question, we do not believe that this final rule arbitrarily or unjustifiably discriminates between countries where similar or identical conditions prevail. Further, it is important to note that this final rule, like the Australian and South African citrus fruit regulations, prohibits the importation of any fruit found to be infected with citrus black spot. Comment: The rate of importation of fruit into the United States should be consistent with the rate of production of a normal lemon farm as if trees were planted today. If I planted a lemon tree today, I wouldn't receive any production for 3 years, and then production would increase gradually through the tenth year. Regardless of current Argentine production available for importation, no lemons should be allowed into the United States during the first 3 years, and then only 15 percent the fourth year, 30 percent in the fifth year, etc. , until full production is allowed. Response: APHIS has no authority to impose the quotas suggested by the commenter. Comment: APHIS should calculate the cost per field box to the American farmer of the cost of U.S. Government regulation and adopt a temporary tariff in that amount on all imported Argentine fruit. The amount collected by the temporary tariff would be distributed to the American lemon farmer based on each farmer's field box production until Argentina adopts the same laws and regulations that the American farmer must obey. The minimum-wage law, Labor Standards Act, and all environmental and health safety laws are examples of such laws and regulations. Response: APHIS has no authority to impose the tariff suggested by the commenter. Comment: APHIS has no regulations that govern the procedure and standards for consideration of import petitions filed by foreign governments. Nor does the website maintained by APHIS provide any information on the process for, or standards which are applied to, such petitions. We submit that APHIS has an obligation to establish its procedures and standards when dealing with plant diseases in such a way as to provide the affected industry with confidence that agency decisionmaking is being conducted in a “reasoned” way based upon substantial evidence in the record and meaningful opportunity for public comment. Response: Foreign governments most often broach the subject of exporting new fruits or vegetables to the United States through formal negotiations or informal contacts with APHIS officials. These requests and any subsequent detailed proposals are reviewed by APHIS staff experts. After that review, APHIS staff may either recommend approval of the petition or contact the petitioning government with a request for additional research, proposed safeguards, etc. As noted by the commenter, this government-to-government contact is not the subject of any procedural regulations in part 319. However, the public is provided the opportunity to review the Agency's basis for any change in the regulations proposed as a result of a foreign government's import petition. Each time we propose to amend our regulations to address an import request that involves a new commodity/region combination, we prepare a proposed rule that is commented upon by the public. In each case, the proposed import program, including mitigation measures, is clearly described in the proposed rule, and the rationale underlying the proposed import program is explained. The public, which includes any potentially affected industry, then has the opportunity to review the proposed rule and its supporting information and may provide comments that must be considered and addressed by APHIS before any final action on a foreign government's import petition may be taken. Systems Approach Comment: APHIS' regulations contain no discussion, definition, or description of what constitutes a “systems approach,” or what treatment or treatments will qualify as an acceptable systems approach. There are no standards in APHIS regulations that permit affected parties to understand or judge the Agency's actions to approve or disapprove such an approach. This is unacceptable. An agency is obligated to set forth the standard the agency is applying or how it is applying that standard to the factual situation. Response: The standard that we apply to any potential import situation is clear and has been well-established over the course of numerous APHIS rulemakings dealing with the importation of agricultural commodities: Does the importation of a particular commodity from a particular region present a risk of introducing pests into the United States, and, if so, can that risk be reduced to a negligible level through the application of phytosanitary measures? These considerations are addressed each time we propose to amend our regulations to address an import request that involves a new commodity/region combination. In each case, the proposed mitigation measures, which can range from something as basic as inspection at the port of entry to a more complicated systems approach of tiered and overlapping measures, are clearly stated in the proposed rule, and the rationale for their proposed use is explained. So, while the general provisions of our regulations do not discuss, define, or describe what constitutes a systems approach or what treatment or treatments qualify as an acceptable systems approach, we do not believe that the lack of such a discussion in the regulations detracts from the public's ability to understand, assess, and comment upon the mitigation measures proposed for a particular commodity/region combination. Comment: Applying a systems approach to disease suppression for the purpose of allowing imports from a region with a disease that does not exist in the United States is a fundamental change in APHIS policy. Previously, APHIS has always demanded that the area in which the crop is grown be completely free of disease and geographically separated from regions with the disease. This principle is applied to citrus canker in the northwestern region of Argentina, but is not the case with sweet orange scab or citrus black spot. There has not been a full scientific discussion of the principles that need to be fulfilled before moving forward with such a fundamental change in the standards for U.S. quarantine pest protection. Therefore: • APHIS should identify and cite the studies that have been used to determine that a systems approach provides sufficient safety from all kinds of plant pests when importing fresh produce into the United States; • APHIS should establish basic standards for the kind of data and experiments that are needed to provide confidence in applying the systems approach to disease control; • APHIS should establish standards by which the information used to determine the effectiveness and practicality of the systems approach are to be judged; and • There needs to be a public discussion of what level of risk is appropriate. Response: We believe that the commenter is incorrect in asserting that APHIS is fundamentally changing its policy by not demanding that a growing area be completely free of disease and geographically separated from regions where disease exists. A long-standing precedent for the local freedom concept is found in the citrus fruit regulations in § 319.28(b)(1), which allow Unshu variety oranges to be imported into certain areas of the United States from Japan and South Korea if the oranges are grown in citrus-canker-free export areas that are surrounded by 400-meter buffer zones. While the Unshu orange program differs from the Argentine citrus program in many respects, the fact remains that the Unshu orange program stands as an example of a successful approach to importing fruit from regions where a disease exists. As noted in the response to the previous comment, it is true that the general provisions of our regulations do not discuss, define, or describe what constitutes a systems approach or what treatment or treatments qualify as an acceptable systems approach. However, we do not believe that the lack of such a discussion in the regulations detracts from the public's ability to understand, assess, and comment upon the mitigation measures proposed for a particular commodity/region combination because, in each case where we propose to allow the entry of a new commodity, we explain the proposed mitigation measures and provide the scientific rationale underlying their proposed use. Thus, the public has the opportunity to judge each proposed importation according to the criteria suggested by this commenter. The commenter states that “APHIS should identify and cite the studies that have been used to determine that a systems approach provides sufficient safety from all kinds of plant pests when importing fresh produce into the United States.” We are unaware of any studies that examine the use of systems approaches as broadly or definitively as the commenter suggests; there are simply too many possible combinations of pests and hosts on one hand, and biological, physical and operational factors that could be integrated into a systems approach on the other, to allow for such a conclusive determination. Thus, while it is acknowledged that systems of practices and procedures can be assembled to provide quarantine security in many cases, each proposed use of a systems approach must be evaluated individually. We will, however, consider the commenter's suggestion that we establish, to the extent possible, general standards for the preparation and evaluation of data that serve to support the establishment of systems approaches. Finally, the commenter states that there needs to be a public discussion of what level of risk is appropriate; we believe that the comments received in response to our proposed rule are one indication that such a discussion of the level of risk that APHIS has determined to be approporiate is already open and ongoing. Given the numerous, evolving, and unpredictable factors affecting the perception of, and tolerance for, risk, it appears that the “public discussion of what level of risk is appropriate” will, by necessity, be an ongoing exchange rather than a discrete deliberation. Comment: APHIS has never before proposed using a systems approach for a combination of diseases and insect pests. What is particularly troubling about the approach APHIS is proposing in the Argentine rule is that the Agency has issued this proposal with no specific discussion of its rationale; its only stated justification is the previous use of system approaches. However, previous systems approaches are similar in only the most remote of ways and are not at all similar in execution or in impact. Thus, the Agency must set forth a detailed justification supported by sound scientific evidence for this fundamental shift in regulatory approach. Further, we submit that APHIS should have adopted this expanded use of a systems approach only after conducting a notice and comment process, with rigorous scientific peer review to determine whether a systems approach can be an effective tool when addressing diseases. Response: It is not true that we sought to justify the use of a systems approach for Argentine citrus by pointing to previous uses of systems approaches; indeed, the proposed rule did not mention the use of a systems approach in any context other than that of Argentine citrus. Further, we disagree with the commenter's contention that we issued the proposed rule “with no specific discussion of its rationale.” Our rationale for the use of a systems approach for Argentine citrus was stated early in the proposed rule, at the end of the first paragraph under the heading “Importation of Grapefruit, Lemons, and Oranges,” where we stated “To prevent the introduction into the United States of those diseases [ i.e., sweet orange scab and citrus black spot] and fruit flies, the Government of Argentina, with the cooperation of APHIS, has formulated a systems approach of tiered and overlapping measures that, when combined with specified cold treatments, would reduce the risks presented by those pests to a negligible level.” The proposed rule then explains in detail each of the phytosanitary measures that would be required in order for citrus to be exported to the United States from Argentina. That explanation, we believe, constitutes the “detailed justification” requested by the commenter. We do not believe that our application of systems approach principles to the importation of Argentine citrus is in any way a departure from our policy of allowing the importation of fruits and vegetables when the risks presented by those commodities can be mitigated to a negligible level. Comment: The systems approach is premised upon the layering of several risk reduction measures. An effective verification and enforcement system is essential for the layering of risk reduction measures to result in the desired outcome. What will be done when one or more of these layers beaks down? APHIS should have a response plan for action when a risk reduction measure fails. Response: The systems approach contained in this rule, as is the case with all systems approaches contained in APHIS' regulations, is indeed premised upon the layering of several risk reduction measures. The tiered and overlapping nature of any systems approach ensures that even if any one of the elements of the systems approach is omitted or fails, and that omission or failure remains undetected, adequate measures will remain to provide the necessary level of phytosanitary security. Further, we agree that an effective verification and enforcement system is essential to the success of any systems approach. To achieve that success, this rule requires that SENASA actively participate in or supervise each step of the process in Argentina to verify and document each step's successful completion or application, and the required documentation must be made available to APHIS. Further, as discussed earlier in this document in the paragraph titled “Monitoring—Argentina,” the operational work plan that addresses the administration of the export program will include provisions for active and direct monitoring of the program by APHIS personnel who will conduct frequent oversight visits to the growing areas and packinghouses in order to observe each step of the program in Argentina. Further, each shipment of fruit must be accompanied by a phytosanitary certificate issued by SENASA that verifies that the fruit was produced and handled in accordance with the requirements of § 319.56-2f(a) through (c) and that the fruit is apparently free from citrus black spot and sweet orange scab. Fruit that fails to meet those requirements will not be eligible for importation into the United States. At the port of entry in the United States, APHIS will inspect the fruit and its accompanying phytosanitary certificate and will confirm that any required cold treatment has been properly applied. Finally, the detection of citrus black spot or sweet orange scab on any grapefruit, lemons, or oranges at any time in Argentina, during transport, or in the United States will result in the grove in which the fruit was grown or is being grown being removed from the SENASA citrus export program for the remainder of that year's growing and harvest season, and the fruit harvested from that grove being ineligible for importation into the United States from the time of detection through the remainder of that shipping season. Comment: For a systems approach to be effective, it is essential to know the biological interactions between the pest and its host to understand how these interactions affect production, shipment, and marketing of commodities. There is very little current knowledge about citrus black spot or sweet orange scab, and virtually no work has been done on the question of how the diseases would respond if brought into the United States. Thus, there is a substantial threshold question of whether a systems approach can even be designed to deal with citrus black spot or sweet orange scab. Response: As neither of those diseases is present in the United States, it is not unusual that most researchers in this country who study citrus crops and their pests have directed their efforts to other, more immediate concerns. However, in countries where citrus black spot or sweet orange scab is present and where citrus is an economically important crop, those diseases have been, and continue to be, the subject of focused research. We believe that the information on the prevention, control, and detection of these diseases that has been collected over the years, combined with the results of the field trials conducted in Argentina, provides the necessary degree of scientific support for the systems approach described in this rule. Comment: APHIS has not used a systems approach previously in a situation where the intended result of the treatments is simply suppression of the symptoms of the disease(s) in a proposed export area. Thus, proposing to rely on an approach which admittedly only results in suppression of the symptoms of the diseases is a fundamental policy shift by APHIS. The proposal also stands in stark contrast to the goal of complete eradication of a disease, which has been and remains the objective in every situation in the United States where a plant disease or pest does exist. As such, any contemplated use of such an approach should be subjected to the most rigorous, exhaustive, and comprehensive level of scientific peer review. Response: The intended result of the treatments, particularly the oil-copper oxychloride sprays during the growing season, as well as measures such as grove cleaning to remove inoculum, is the prevention of infection, and not simply the suppression of symptoms as stated by the commenter. Other required measures are specifically designed to detect the presence of diseased fruit and prevent its importation into the United States. Given that the goal of this rule is to provide for the importation of disease—free and not simply asymptomatic—grapefruit, lemons, and oranges, we do not believe that this rule represents a departure from our policy of allowing the importation of fruits and vegetables when the risks presented by those commodities can be mitigated to a negligible level. Comment: A publication titled Quarantine Treatment for Pests of Food Plants (edited by Jennifer L. Sharp and Guy J. Hallman, Westview Press, 1994), includes a discussion of systems approaches that stresses the importance of determining the level at which a pest or disease exists in order to design an effective systems approach. Nothing on the record of the Argentine proposed rule indicates the “level of infestation” of the host fruit by any of the diseases or pests at issue. This infestation information must be known before APHIS can even consider the possibility of designing a systems approach. Only when this infestation level is known can the efficacy of the proposed system be judged. Without this information, interested parties are unable to conduct any meaningful review of the proposed systems approach. Response: The “level of infestation” passage noted by the commenter is found on page 226 of the cited publication and states “* * * [S]ystems recognize that the commodity in question is a host, the level of infestation in the host being the key component in the design of the overall system. Systems rely on knowledge of the infestation level of the host and measure the impact of the various operational procedures on removing infested hosts, thereby reducing the risks that infested hosts will be shipped.” For the fruit flies of concern in Argentina, a single quarantine treatment—cold treatment—is available and is required by this rule, which leaves citrus black spot and sweet orange scab as the “diseases or pests at issue.” Surveys produced by Argentina show that disease incidence— i.e., the “level of infestation” referred to in the cited publication—varies from season to season, depending on the prevailing environmental conditions, and can be high in untreated groves. The results of those surveys were reported in the risk assessment that accompanied the proposed rule, so there is in fact information on the record indicating our knowledge of disease incidence in Argentina. Because of the known seasonal variations in disease incidence, the design of the systems approach for Argentine citrus began with the assumption of a potentially high “level of infestation” and set out, through biological and operational factors such as buffer zones, inoculum removal, inspections, testing, and treatments, to reduce the risks of infected fruit being shipped to the United States. Comment: It is not possible to properly assess the adequacy of a systems approach in preventing the introduction of pests into an importing nation without detailed knowledge of the circumstances under which a pest occurs, and the frequency with which it occurs, in the export region. APHIS' current risk assessment is based on a poor body of knowledge of insect species present or potentially present in Argentina, particularly the Anastrepha species present in northwestern Argentina. Further, the level of pesticide use there could be masking the presence of lesser-known pests that could emerge as a problem if newer, more specific pesticides are used in Argentina. Therefore, extensive taxonomic research and population surveys on fruit flies and other insect species present in northwestern Argentina, as well as data on other potential hosts in that region, are necessary in order for a proper risk assessment to be completed on Argentine citrus and for the systems approach to be fully evaluated. Response: Citrus is an economically important crop in Argentina, and as such has been, and continues to be, the subject of well-supported and vigorously pursued research into its production and factors affecting that production, including pests. We are confident, therefore, that the pest list produced by SENASA, which was reviewed by APHIS and by agricultural officials in the four main citrus-producing States of this country and compared against reports from various international sources and the scientific literature, accurately addressed the range of citrus pests present in Argentina. Further, we believe that the risks posed by those pests were adequately considered in the risk assessment and addressed by the provisions of this rule. Comment: What is the goal of the systems approach for citrus black spot and sweet orange scab? Some of the statements in the rulemaking record imply that the goal is to have disease-free groves, while the proposed rule seems to seek the suppression of disease symptoms in export groves. Recent statements by APHIS imply that it would be acceptable for diseased fruit to enter the United States. Response: The goal of the systems approach is to reduce the plant pest risks associated with the importation of Argentine citrus to a negligible level. With regard to citrus black spot and sweet orange scab, the systems approach is designed to accomplish that goal through both prevention and detection; the grove cleaning and growing season spraying requirements are designed specifically to prevent fruit from becoming infected in the first place, and subsequent surveys, inspections, and testing provide multiple opportunities for the detection of infected fruit. If a single infected fruit is found at any point in the process, including inspections conducted after the fruit has arrived in the United States, the grove in which that fruit was grown will be removed from the SENASA citrus export program and the fruit harvested from that grove may not be imported into the United States from the time of detection through the remainder of the shipping season. Thus, the commenter's impression that we would find it acceptable for diseased fruit to enter the United States is incorrect. Comment: The record of data supplied by Argentina, as provided to the public by APHIS, is completely inadequate to assess the efficacy of the individual measures, let alone the systems approach, for citrus black spot and sweet orange scab. Either APHIS has not maintained a complete record of the information Argentina supplied, or the Agency is basing its risk estimates on ambiguous data because of inadequate reporting by Argentina. Response: We have, in fact, maintained a complete record of the information supplied by Argentina, and we did share that information with the commenter, although we were unable to provide the information that was the subject of the commenter's FOIA request until after the close of the comment period. Further, it is important to note that our assessment of the risks presented by Argentine citrus and of the efficacy of specific measures was not based solely on the material provided by Argentina; information gathered from other sources and the expert judgment of subject matter specialists also played a role. This is the norm when conducting probabilistic assessments to inform decisions regarding importation of agricultural commodities. When data that represent “direct evidence” do not exist, which is often the case in probabilistic risk assessments, available information is reviewed and applied through the use of professional judgment. APHIS bases the estimates needed for its probabilistic commodity risk assessments on pest interception records, the known biology of the organism being assessed (or the known biology of related taxa) as represented in the scientific literature, expert judgment based on laboratory experience with the pest or related organisms, expert judgment based on field experience with the pest or related organisms, expert judgment based on experience conducting commodity inspections at ports of entry or in the exporting country, and experience working with export programs and export-quality commodities. Thus, we believe that the entire body of information available is, in fact, sufficient to support the efficacy of the measures required by this rule and our analysis of the risks associated with Argentine citrus. Comment: The following items are examples of the type of data or information that appear to be missing from the rulemaking record. No information is provided as to what the climatic conditions were in the tested groves during the spraying program. Similarly, no information is provided on how the spraying program would be affected by different climatic conditions in different growing areas, such as the northwestern versus the southern part of Tucuman, and Tucuman as compared to Salta, etc. Accordingly, it was impossible to answer many critical questions: Was it a year of light incidence of the disease, and thus the spraying was very effective? What would happen in a year of heavy incidence? What were the ages and varieties of the trees in the program? What was the protocol that was followed? How would different climatic conditions affect the spraying program? Would the same results have been achieved if the trees had been 10 years older? Neither the risk assessment nor the rulemaking record addresses or answers any of these questions. APHIS must require much more extensive tests covering multiple variables before further considering the Argentine petition. Variables that should have been included in tests before approving the Argentine petition would include, but are not limited to: Multiple and differing climatic situations ( i.e., drier versus more humid areas; more humid years versus drier years); differing ages of trees, since citrus black spot is more often seen in older trees and in ripe fruit; differing sizes of groves; whether the grove was virtually surrounded by untreated groves; whether the trees had been under any type of stress; etc. Response: The bioecological factors affecting citrus black spot development that were considered in the design of the field testing conducted in Argentina, the protocols for the field tests, and the results of those tests are among the material provided to the commenter in Note S.P. 338 of December 5, 1995, and its three annexes (“Bioecology of Black Spot in Citrus,” “Field Assays for the Control of Black Spot in Citrus,” and “Results of the Postharvest Assays Carried Out up to the Present”). These documents demonstrate that Argentina recognized, and took into account, that factors such as climate, humidity, fruit susceptibility, and the presence of inoculum have an effect on the presence of the disease. The Argentine field tests were conducted during growing seasons marked by both dry conditions with light disease incidence in control trees and prolonged rainy conditions with a heavy incidence of disease in control trees. This information, which was used in the design of the systems approach, was also considered by the experts who prepared the risk assessment. As noted elsewhere in this document, the systems approach is designed to mitigate the risk of citrus black spot during years in which the disease is likely, which is why this rule requires in part that the timing of the fungicidal sprays be determined by SENASA using an expert system that takes climatic data, as well as fruit susceptibility and the presence of disease inoculum, into account. We believe that the body of information contained in the rulemaking record, including the research and testing data provided by Argentina, provides the necessary scientific and rational basis for our regulatory decisionmaking. Comment: The evidence that APHIS has made available to date is inadequate to support the proposed rule. The Secretary should appoint an independent scientific team to travel to the proposed Argentine production area when climatic conditions are appropriate, and that team should be given access to the production and packing facilities, as well as to the transportation and port operations that would be utilized for the export program. The Secretary should direct that team to report its findings to the Department and Congress. Response: APHIS, under the authority of the Plant Quarantine Act and the Federal Plant Pest Act, has reviewed the Argentine petition and has made the determination that phytosanitary measures that comprise the systems approach reduce the pest risk to a negligible level. The systems approach that is the subject of this rule was developed in Argentina by that country's plant health officials and citrus interests and was presented, along with its supporting data, to APHIS for review. APHIS rejected Argentina's initial proposal on the grounds that it did not sufficiently mitigate the pest risk presented by Argentine citrus. It was only after Argentina included additional phytosanitary measures in its systems approach and provided what we determined to be an adequate amount of additional efficacy data that APHIS accepted the Argentine proposal. The Secretary is not required to appoint an independent scientific team as suggested by the commenter, nor do we believe that one is needed in light of the review already conducted by APHIS. Comment: The 1997 risk assessment states that the level of visible incidence of citrus black spot can be extremely high in Argentina—as high as 82 percent and can vary greatly year to year. This level of disease incidence is disturbingly high. Further, this data does not address the phenomenon of symptoms that remain latent. Based on the current state of science, we submit that no fruit from such highly diseased areas should be allowed to enter the United States. Response: The section of the risk assessment cited by the commenter stated that in untreated export-area orange groves, field surveys for citrus black spot in 1994 and 1995 found 14 percent and 82 percent, respectively, of sampled fruit were infected with the citrus black spot fungus, and a similar 1996 survey found that 56 percent of the sampled trees in an untreated lemon grove bore fruit with citrus black spot symptoms. The risk assessment further states, however, that in the 1994 survey, citrus black spot incidence was reduced from 14 percent in control groves to 0 percent in treated orange groves; in the 1995 survey, citrus black spot incidence was reduced from 82 percent to 11 percent; and in the 1996 lemon survey, none of the trees sampled in treated groves bore fruit with citrus black spot symptoms. These tests show that the incidence of citrus black spot can be significantly reduced by orchard treatments, which is just one aspect of the systems approach, even when the level of disease in the area is high. The issue of asymptomatic, latently infected fruit is addressed by the rule's requirement that a sample of fruit collected according to a statistically valid sampling protocol be held for 20 days under conditions that are ideal for producing symptoms in infected fruit. We believe that this rule provides an array of effective measures to reduce to a negligible level the risk of introducing citrus black spot into the United States. APHIS Involvement Comment: The proposed rule does not provide for APHIS personnel to perform any of the required inspections in Argentina. APHIS personnel should inspect all groves according to a detailed protocol, and the Argentines should pay all costs associated with such inspections. Response: APHIS routinely relies upon the national plant protection organizations of exporting countries to provide the supervision or certification of phytosanitary measures that might be required for specific agricultural commodities, just as other countries rely upon APHIS to provide such services. We have had the opportunity to work with SENASA on numerous phytosanitary issues in the past and, as a result, we have every confidence in SENASA's ability to administer and supervise the citrus export program established by this rule. SENASA, as the national plant protection organization of Argentina, has a well-established infrastructure in place throughout the country. Also, SENASA personnel were involved at every step in the development of the systems approach, so they are as familiar as APHIS with its requirements. Further, SENASA personnel possess a level of familiarity with Argentine groves, growers, and citrus production that APHIS personnel do not. Given these considerations, we do not believe that any appreciable advantage would be gained, from a plant protection/risk reduction perspective, by requiring Argentina to pay for APHIS to establish a new operational presence in that country. However, as discussed earlier in this document in the paragraph titled “Monitoring—Argentina,” the operational work plan that addresses the administration of the export program will include provisions for active and direct monitoring of the program by APHIS personnel who will conduct frequent oversight visits to the growing areas and packinghouses in order to observe each step of the program in Argentina. Comment: APHIS does not have a sufficient number of employees stationed in Argentina to provide an adequate level of monitoring for the proposed export program. Response: As noted in the response to the previous comment, we have every confidence in SENASA's ability to administer and supervise the citrus export program established by this rule. Accordingly, this rule does not require direct APHIS supervision of the activities of the citrus export program carried out in Argentina, so APHIS staffing in that country is not an issue. While APHIS personnel will travel to the production areas in order to monitor the progress of the export program, especially during the first season, this rule provides for the direct supervision of the measures required in Argentina to be carried out by SENASA. Origin Requirement Comment: The proposed rule does not provide for annual surveys on citrus canker. Such surveys should be made, records should be kept, and audits should be required. Response: Argentina has an ongoing monitoring program, as well as quarantine protection systems, for citrus canker that have been in place since 1992. Because Argentina's monitoring program is conducted in accordance with United Nations' Food and Agriculture Organization (FAO) standards, which include reporting and recordkeeping requirements, we do not believe that it is necessary for this rule to impose additional or redundant requirements regarding citrus canker surveys. Comment: If APHIS allows the importation of Argentine citrus, it should impose movement restrictions on Argentine citrus similar to those of its domestic citrus canker regulations. Response: Our domestic citrus canker regulations apply to fruit grown or packed in areas that are quarantined due to the presence of citrus canker. Because it has been established in accordance with international standards that northwestern Argentina is free of citrus canker, such movement restrictions are neither necessary nor justifiable. Comment: According to the risk assessment, the median chance of citrus canker becoming established in the United States with no pest mitigation program is estimated as 1 chance in 4 trillion per year. The extremely low value for this risk estimate can partially be attributed to the fact that northwestern Argentina is assumed to be free of citrus canker. However, even if it is assumed that 100 percent of the boxes of fruit were initially infected (instead of the average of 0.05 percent assumed in the risk assessment), the likelihood of citrus canker establishing itself in the United States would be 1 in 2 billion per year, according to the analysis performed by APHIS. If it is really this improbable that citrus canker will become established in the United States, why does the risk assessment even address citrus canker? Why does the United States currently prohibit the importation of citrus fruit from countries where citrus canker occurs and regulate the interstate movement of citrus fruit from infested areas of the United States? On the one hand, APHIS states that no outbreak of citrus canker has ever been traced to the importation of fruit, and hence estimates a very low probability that citrus canker will occur. In contrast, the risk assessment's pest data sheet indicates that citrus canker can potentially move long distances on diseased fruit, that at least three outbreaks of citrus canker have occurred in the United States within the past 100 years, and that there is currently citrus canker in Florida. This information seems to indicate a risk greater than 1 in 2 billion per year, and suggests that the quantitative estimate is incorrect. Response: The fact that northwestern Argentina has been demonstrated to be free of citrus canker in accordance with international standards was an important factor in our assigning an “extremely low value for this risk estimate.” Another important factor in that risk estimate is the evidence that the long-distance spread of citrus canker has occurred primarily through the movement of infected planting and propagating materials. The commenter reports that the pest data sheet indicates that the pathogen could potentially move long distances on diseased fruit, but omits the second half of the sentence in which that statement appears, wherein we report that there is no authenticated example of a disease outbreak that initiated from diseased fruit. Given the preponderance of evidence and expert opinion that long-distance spread occurs primarily through the movement of infected planting and propagating materials, and given the absence of documented cases of citrus canker outbreaks attributable to the movement of infected fruit, we believe that the probability calculated by the commenter is actually not unreasonable and our assessment of the risk posed by citrus fruit from the citrus-canker-free States of northwestern Argentina is appropriate. The larger question of whether citrus canker may be spread long distances on diseased fruit has not been answered to the satisfaction of some in the citrus production and research communities, which accounts for our continuing restrictions on the importation and interstate movement of citrus fruit from areas where the disease occurs. Comment: If the fruit from northwestern Argentina passes through that country's eastern regions, which are not free from citrus canker, it is possible that the fruit could be contaminated by airborne citrus canker bacteria during transport. Response: As stated in the pest data sheet for citrus canker provided in the risk assessment, short-distance dispersal of the pathogen in groves occurs primarily by wind-driven rain (rain and wind in excess of 6—8 m/sec) that causes the water soaking in leaves necessary for infection and causes entrance wounds when shoots are injured by wind whipping. The pest data sheet also notes that overhead irrigation may also play a role in short distance spread, as may mechanical equipment used in grove maintenance (Ferguson, et al. , 1985; Swings & Civerolo, 1993). Given that citrus fruit traveling from the packinghouses in the production areas will be boxed, with those boxes being protected from the elements to prevent damage, we do not believe that there is any appreciable risk of the fruit being contaminated by airborne citrus canker bacteria during transport. Comment: In a 1994 report that is part of the rulemaking record, APHIS personnel who visited Argentina stated that they had concerns regarding an apparent lack of inspection at the local airports with regard to citrus canker. Has this issue been satisfactorily addressed? Response: This issue was addressed following APHIS' 1994 trip. Argentina has established quarantine control stations at all main entrances to the citrus-canker-free States, including quarantine checkpoints at local airports. Comment: Although it is claimed that the four States of northwestern Argentina listed in the proposed rule are free from citrus canker, it may be that citrus canker does actually exist in those States but is inhibited by warm temperatures and dry climate. Response: Argentina's monitoring system for citrus canker consists of inspections and systematic sampling carried out annually in all production areas as well as in urban areas and nurseries. The collected samples are analyzed at university and research center laboratories using a high-sensitivity immunofluorescence serologic technique. Since this monitoring system was implemented in 1992, no evidence of citrus canker has been found. We are, therefore, confident that citrus canker is not present in the four northwestern Argentine States. Grove Requirements Comment: The 150-meter buffer zone appears to be inadequate for mitigating the spread of citrus black spot spores dispersed long distances by the wind. Response: The buffer zone is designed to reduce to an insignificant level the possibility that ascospores from an infected grove would reach a grove producing fruit for the U.S. market. The ascospores are the only wind-dispersed propagule of black spot and are produced in leaves on the ground, usually under the tree canopy. Environmental conditions must be correct for ascospores to be dispersed ( i.e. , rain to promote the release of the ascospores followed by sufficient wind to move the ascospores from under the overhanging canopy of the tree). The combination of the prevention of long-distance movement by the canopy itself and the presence of a 150-meter buffer that, like the export area of the grove, must be cleaned of all fallen leaves and other debris before blossom, will significantly reduce the unlikely possibility that ascospores from outside the area of production will reach the production area. Additionally, because environmental conditions are monitored and control methods are utilized during periods when the developing fruit is susceptible to infection, the likelihood of successful infection is negligible. Comment: The risk assessment claims all new citrus stock in the canker-free area must originate within the zone (which we assume to mean the canker-free area) or be tissue culture that has passed through quarantine, whereas the proposed rule only requires new citrus stock planted within the export groves to meet those requirements. Does the risk assessment therefore overestimate the protection offered by this measure? Response: The citrus stock origin requirements referred to by the commenter as being in the risk assessment are existing requirements established and enforced by SENASA as part of that agency's program to maintain the citrus-canker-free status of the northwestern Argentine States. SENASA's citrus stock origin requirements apply to all groves in the citrus-canker-free area of Argentina; therefore, the risk assessment's characterization of those requirements is correct and does not overestimate the protection offered by those requirements. Because the requirements of this rule pertain only to groves that produce fruit for export to the United States, the rule does not extend those requirements to other groves producing fruit for other export markets or for domestic consumption within Argentina. Comment: The proposed rule provides that any new citrus planting stock used in a certified grove must originate from one of the four States or from a SENASA-approved propagation center (§ 319.56-2f(b)(3)). It is not clear whether this requirement goes only to citrus canker, or whether it also applies to citrus black spot and sweet orange scab. If it does not apply to citrus black spot and sweet orange scab, what precautions will be taken to insure that planting stock does not carry these diseases from within the approved areas? Evidence must be included in the record that such precautions will be effective. Response: As explained in the response to the previous comment, the citrus stock origin requirements are part of SENASA's program to maintain the citrus-canker-free status of northwestern Argentina. Thus, those requirements apply only to citrus canker, and not to citrus black spot or sweet orange scab. Because this rule is not based on the four northwestern Argentine States being a free area for citrus black spot or sweet orange scab, it was not necessary to include provisions for the freedom of planting stock from those two diseases. Comment: The preamble to the proposed rule states that domestic-origin citrus plants must meet “strict phytosanitary requirements” before they may enter the four States that will be allowed to export. Is this reference to the SENASA requirements for a propagation center? Response: Yes. The requirements referred to in the preamble of the proposed rule pertain to the testing and grow-out regimen conducted at SENASA-approved citrus stock propagation centers for citrus stock that has been imported into Argentina and for any domestic-origin citrus plants from outside the four citrus-canker-free States. As stated in the proposed rule, citrus plants from sources outside the citrus-canker-free area “must meet strict phytosanitary requirements before they may enter the States of Catamarca, Jujuy, Salta, or Tucuman. Under SENASA supervision, such citrus plants are officially tested to ensure their freedom from quarantine pests and diseases, and are grown in quarantine before being released for use in the citrus canker-free area of Argentina.” Comment: The preamble implies that nursery stock will be “tested.” However, citrus black spot is a latent disease. Can it be successfully detected years in advance of when it appears? If tests cannot be carried out, what precautions will be taken to ensure that stock that may be from groves infected with sweet orange scab or citrus black spot is not planted in noninfested groves? Answers to these questions do not appear in the rulemaking record. Without such answers, APHIS should not proceed with the proposed rule. Response: As noted previously, SENASA's requirements, and the requirements of this rule, pertaining to planting stock are intended to prevent the introduction of citrus canker into the citrus-canker-free area of northwestern Argentina; because the four Argentine States are not a free area for citrus black spot or sweet orange scab, those measures are not intended to provide protection against citrus black spot or sweet orange scab introduction via nursery stock. The risks presented by those two diseases are instead mitigated by the pre-and post-harvest treatment and inspection requirements of this rule. Comment: The risk assessment speaks only of the removal of fallen fruit and leaves in the grove, but implies immediate and continuous removal. The proposed rule considers fallen fruit, leaves, and branches in both grove and buffer zone, but specifies removal only before blossoming in the grove (but not necessarily before blossoming in the buffer zone, or in any regions outside the buffer zone). If the buffer zone contains fruit blossoming earlier than the grove, the fruit is more likely to become infected if there is contaminated material remaining on the ground, but such infection is less likely to be observed/reported. Response: The buffer zone immediately surrounds the grove—indeed, it would be part of the grove if the owner was not producing fruit for export to the United States—so it is not likely that the trees in the buffer area will be blossoming any earlier or later than the trees in the export portion of the grove. Comment: The proposed requirement for the removal of all fallen fruit, leaves, and branches from the orchard floor and the buffer area is not a biological, well-justified safeguard. Research on attempts to decrease incidence in other, similarly dispersed diseases through cleaning of groves indicated that, while leaf and fruit removal could remove about 90 percent of the inoculum, the 10 percent of inoculum still present was more than sufficient to maintain the presence of the disease. It is very likely that ascospore inoculum will remain in the ground and any out-of-season or late-hanging fruit will supply additional inoculum. Response: The removal of fruit, leaves, and branches from the orchard floor and buffer area is a biologically justified safeguard. Because the ascospores of citrus black spot are produced only in fallen leaves, the removal of this debris will significantly reduce the inoculum level. This is a part of a control strategy that is used by plant pathologists for diseases for which inoculum is produced in fallen debris. Because this is only one part of a systems approach, it is designed to reduce the likelihood of infection, not prevent it entirely. Therefore, we have taken into account in the risk analysis the possibility that debris may remain on the ground or in late season fruit. Comment: The proposed rule requires that export groves be cleaned of debris, leaves, and fallen fruit before bloom to remove the main sources of disease inoculum. Argentine researchers monitored leaf fall during a whole season and found that for all three citrus species in Salta, the majority of leaves fell between August and November, while fruit set occurred from September to October. Thus, the maximum leaf fall is occurring during bloom and fruit set. Furthermore, the summer rains, which are needed for development of citrus black spot on the dead leaves, tend to start in October. If decreasing inoculum through removal of fallen leaves is the goal to protect the developing fruit, then there must be continuous cleaning of the grove throughout the maximum leaf fall period, otherwise fruit will be developing in the presence of leaf litter as a potential source of inoculum. Response: A thorough cleaning of the grove and buffer area prior to blossom will remove a significant amount of potential inoculum. Any ascospores on leaves that fall after the cleaning of the grove will not form ascocarps until 40 to 180 days after blossom, depending on the frequency of wetting; by that time, the preventive oil-copper oxychloride sprays will be in use to protect the developing fruit from infection. If the removal of fallen fruit, leaves, and branches was the only measure employed to reduce the risk of citrus black spot infection during the growing season, additional cleaning would likely be advisable, but given the additional requirements of this rule, we do not believe that is necessary. Comment: The proposed requirement for the removal of all fallen fruit, leaves, and branches from the orchard floor and the buffer area would be difficult, if not impossible, to satisfy. We suggest that the word “substantially” be inserted before the word “all” to make this requirement more realistic. Response: Although the grove/buffer sanitation requirement may be difficult to meet, SENASA and the growers in northwestern Argentina have indicated their willingness to comply with that requirement. Further, it would likely prove difficult to establish a standard for what is meant by “substantially all.” Comment: The proposed grove-cleaning would be a difficult, if not impossible, task to complete. The proposed rule does not explain what criteria will be used to verify the orchard floor cleaning and how it can be verified at a later date. Response: The proposed rule and this final rule state that SENASA must inspect the grove and buffer area before blossom to verify that all fallen fruit, leaves, and branches have been removed from the ground. In the phytosanitary certificate required by paragraph (d) of the regulations, SENASA must confirm that the fruit was produced in accordance with the requirements of the regulations; the grove and buffer area sanitation measures are one of those requirements. SENASA will keep records regarding its inspection of each export grove and buffer area, and APHIS may request to review those records. Further, as noted previously in this final rule, the operational work plan governing the administration of the export program will provide for the active and direct monitoring of the export program by APHIS personnel; that monitoring will include verification of the required grove sanitation measures. Comment: The risk assessment states that groves are inspected for disease symptoms prior to fungicide applications, and fruit with possible disease symptoms is sent to a laboratory for analysis. The timing of fungicide applications is determined by “an expert system.” In section 8.f. P1 of the risk assessment, it indicates that the export groves would have a “minimum of two or three additional applications” of fungicide, as opposed to the total of at least two specified in section 8.a. of the risk assessment and in the proposed rule. The proposed rule states that SENASA will determine timing of fungicide applications “during the growing season,” based on monitoring of climatic data, fruit susceptibility, and the presence of disease inoculum, and will monitor for correct fungicide application. There is no requirement in the proposed rule for inspection of the groves for pests at times of fungicide application, nor for laboratory analysis of suspect fruit at this time (if there is any fruit at the times of spray application). There is no discussion of what is meant by “presence of disease inoculum.” There is no requirement that the fungicide treatment include any fruit, leaves, or branches on the ground that have not been removed. It is not required by the proposed rule that SENASA use an expert system to determine fungicide application times. Response: After the risk assessment was prepared, and before the provisions that formed the basis of the proposed rule were fully developed, SENASA suggested that the inspections be conducted after the fungicide treatments, when there is a better chance of detecting the disease; this accounts for the difference between the risk assessment (which speaks to inspection before fungicide treatment) and the proposed rule on this subject. The oil-copper-oxychloride treatments will be applied during the period of greatest susceptibility of the fruit to infection ( i.e. , from the time that three quarters of the petals have fallen to the time the fruit have reach 3 cm in diameter). Given that disease symptoms are unlikely to be manifested at that stage of fruit development, the proposed rule did not, and this final rule does not, call for inspections prior to the application of those treatments or the laboratory inspection of suspect fruit at that time. With regard to the number of oil-copper-oxychloride applications, section 8.f P1 of the risk assessment did, as noted by the commenter, state that groves would receive “a minimum of two or three additional applications of fungicide,” while elsewhere in the risk assessment and in the proposed rule the number of applications was characterized as “two or more” and “at least twice.” However, the way in which the number of applications was characterized did not have any effect on our estimation of the mitigation value of the fungicidal sprays. Our estimates were not based on any finite, predetermined number of sprays; rather, the risk assessment assumed that the timing and number of sprays would be determined using SENASA's expert system, with the optimal number of sprays being applied to prevent infection. With regard to the term “expert system,” which was used in the risk assessment, we chose to describe the components of the system in the proposed rule ( i.e. , monitoring of climatic data, fruit susceptibility, and the presence of disease inoculum) rather than simply use the term itself. The risk assessment and the proposed rule are, therefore, referring to the same thing. We have included the term “expert system” in § 319.56-2f(b)(5) of this final rule to make that clear. With regard to what is meant by “presence of disease inoculum,” SENASA's monitoring of the presence of disease inoculum considers both the presence of fallen leaves within the grove, as leaves have been identified as the primary source of inoculum, as well as the incidence of disease in the area surrounding each grove. We did not include provisions for the spraying of fruit, leaves, or branches that may be on the ground because the oil-copper-oxychloride treatment is intended to prevent infection in the developing fruit itself and because the required grove sanitation measures are intended to leave the ground in the grove free of such debris. Comment: Eureka-type lemons, which are commonly planted in Argentina, do not have a very distinct start and finish of flowering, depending on climatic conditions. Under mild winter conditions, flowering can occur year round; indeed, some reports indicate that lemons are harvested year round in Tucuman province. In one report, Argentine researchers observed both immature and mature lemons on the sampled trees at the same time in Salta and noted that the presence of different aged fruit provides for an additional risk of fruit infection. How can a grove be certified as having been cleaned prior to bloom when bloom is not specifically seasonal? Response: While there may be multiple blooms in a year under mild winter conditions, Argentina reports that there is, as occurs in the United States, a main spring flush during which most of the trees will bloom, and it is the fruit from those trees that will be exported to the United States. Therefore, the blossoming period in the Argentine production areas is distinct enough to allow for the cleaning and inspection of the groves and buffer areas prior to blossom. Comment: The timing of flowering in not necessarily distinct in some common lemon varieties, and it is not clear how the timing of the oil-copper-oxychloride treatments will be determined when flowering and fruit set occur over several months. The efficacy studies of the fungicide treatments need to provide for careful testing of timing of the treatments to deal with the different bloom lengths, fruit set, rainfall patterns, and disease incidence in the different citrus species and the different regions. Response: The timing of each treatment application will be determined by SENASA using an expert system that considers climatic data (including temperature and rainfall patterns), fruit susceptibility (which is dictated in part by the timing and length of bloom, when fruit set occurred, and the relative disease susceptibility of each species), and the presence of disease inoculum (which takes into account both the presence of fallen leaves within the grove, as leaves have been identified as the primary source of inoculum, and the incidence of disease in the area surrounding each grove). The goal of the expert system is to maximize the effectiveness of the oil-copper-oxychloride treatments in preventing the fruit from becoming infected. Whether or not that goal has been met will become apparent during the laboratory incubation and examination of the 20-day preharvest sample, as well as through the grove and packinghouse inspections. Comment: The proposed rule fails to require that certified groves keep detailed records of the various blooms and required program steps ( e.g. , when the spraying and debris-clearing programs are carried out). Any program which APHIS develops should be subject to further public comment. Response: There is no need for APHIS to develop a recordkeeping program as suggested by the commenter. As stated in the proposed rule and in this final rule, SENASA is responsible for inspecting the registered groves prior to blossom to ensure that the required sanitation measures have been accomplished, as well as for determining the timing of the oil-copper-oxychloride treatments and monitoring their application. SENASA will maintain records of these activities as part of its citrus fruit export program, and will make those records available to APHIS during program reviews or when otherwise necessary. Comment: From the APHIS-SENASA correspondence, it is clear that APHIS had wanted an inspection of the orchard prior to the fungicide treatments. However, SENASA requested that the inspection for disease occur after the treatments. APHIS must explain its reasoning for why the inspection of a grove for disease before fungicide applications was not included in the proposed rule. Response: Until the fruit has matured somewhat and has begun to color, the symptoms of citrus black spot will not be apparent. Since the fruit would be too small and would not have colored yet prior to the fungicide applications, we concurred with SENASA's suggestion that the inspections be conducted after the treatments, when there is a better chance of detecting the disease. Comment: No specific rate for the copper oxychloride sprays is provided in the proposed rule. It appears that the Argentine researchers found that a rate of 0.36 percent was more effective in preventing the disease, but SENASA has stated that a rate of 0.18 percent would be used for the export program, which may be ineffective at least some of the time or on some fruit, according to the information in the record. APHIS should determine why the lower copper oxychloride rate was chosen by SENASA, even though the data showed the higher rate to be more effective. Response: The lower oil-copper-oxychloride application rate was recommended by SENASA based on its studies that showed that the 0.36 and 0.18 percent application rates were both effective in preventing disease in test plots when the disease was evident in the control plots. Given that the 0.18 percent application rate was shown to be effective in preventing disease, and given that this rule requires at least two applications of the fungicide during the growing season, we have accepted SENASA's recommendation that the 0.18 percent application rate be used. Comment: It appears that Argentine researchers performed only one test to assess the effectiveness of the in-season fungicide treatments for sweet orange scab and that only one test was conducted using both in-season fungicide treatments and post-harvest chemical treatments. This limited testing is not sufficient to determine the effectiveness of the proposed measures. APHIS should provide or cite efficacy data for the proposed copper oxychloride sprays on the incidence of sweet orange scab. Response: The American Phytopathological Society's Citrus Compendium (Whiteside et al. , 1988), which was cited in the body of the risk assessment (p. 57) and in the pest data sheet for sweet orange scab (p. 101), indicates that copper sprays are effective protectants to prevent the infection of susceptible fruit by sweet orange scab. Comment: While the risk that sweet orange scab might be introduced into the United States may be reduced by timely, reliable, and negative surveys, there are still some unresolved taxonomic issues surrounding the Elsinoe specie [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%3A00-14851. Public record. Not legal advice.