Daily Rules, Proposed Rules, and Notices of the Federal Government
The regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56 through 319.56-8, referred to below as the 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 spread of plant pests.
On October 1, 2002, we published a proposed rule in the
We solicited comments concerning our proposal for 60 days ending December 2, 2002. We received 60 comments by that date. They were from growers, packers, shippers, industry and trade representatives, and representatives of State and foreign governments. While 42 commenters wrote to support specific portions of the rule, 18 wrote to express concern or object to some aspect of the proposed rule. These comments are discussed below.
Given that certain Animal and Plant Health Inspection Service (APHIS) functions and personnel were moved to the Department of Homeland Security (DHS), one commenter recommended that we delay issuing a final rule based on the proposed rule because a transition period is not an appropriate time to add new responsibilities and procedures. While we are allowing additional fruits and vegetables to be imported into the United States and are making other amendments to update and clarify the regulations and improve their effectiveness, we do not consider these amendments as new responsibilities and procedures. Therefore, we are not delaying this final rule as a result of the transfer of functions to DHS.
In accordance with Executive Order 12988, we included a statement in our proposed rule giving notice that any State and local laws and regulations regarding the importation of fruits and vegetables under this rule would be preempted while the fruits and vegetables are in foreign commerce. Two commenters objected to this language concerning the preemption of State and local laws. One commenter was concerned that APHIS was imposing mandates upon State and local governments by preempting their authority to restrict entry of fruits and vegetables imported under the regulations, without assuming the full cost of eradication for pests and diseases that may be hitchhiking on these commodities. Both commenters objected to the concept that imported fruits and vegetables are considered in foreign commerce until sold to the ultimate consumer.
One of the requirements under Executive Order 12988 is that a Federal agency specify in clear language the preemptive effect it believes will be given to its regulations. Preemption in foreign commerce is specifically addressed in § 436(a) of the Plant Protection Act (7 U.S.C. 7756(a)), which states that “[n]o State or political subdivision of a State may regulate in foreign commerce any article, means of conveyance, plant, biological control organism, plant pest, noxious weed, or plant product in order—(1) To control a plant pest or noxious weed; (2) to eradicate a plant pest or noxious weed; or (3) prevent the introduction or dissemination of a biological control organism, plant pest, or noxious weed.” When foreign commerce ceases is a question of fact that must be addressed in each individual case. However, the Department of Agriculture has taken the position that fresh fruits and vegetables imported into the United States for immediate distribution and sale remain in foreign commerce until they are sold to the ultimate consumer. Other questions regarding when foreign commerce ceases must be addressed on a case-by-case basis and will be resolved based on the facts in each particular case.
One commenter recommended that the economic analysis address, in detail, the economic effects of domestic infestation that could occur under the proposed regulations. APHIS conducts economic analyses for import-related rulemaking using the assumption that the importation of a particular commodity will not result in the introduction of pests or diseases; indeed, the prevention of such introductions is a primary goal of those rulemakings. APHIS does, however, routinely attempt to quantify, to the extent possible, the size (in dollar terms) of the domestic industry that stands to be affected by a rulemaking. The introduction of a pest or disease would likely be detrimental to the economic health of that domestic industry, as well as related industries. However, without some indication as to the actual or likely scope of a pest or disease outbreak, any estimate of losses would have to range from somewhere above zero to 100 percent. Further, if we had a sense that an outbreak was likely, we would not promulgate the rule.
Another commenter stated that APHIS’ relaxation of U.S. standards, while foreign trading partners continue to strengthen their opposition to similar standards, is multiplying the economic harm to American agricultural interests and amounts to “unilateral agricultural disarmament” in the international trade arena. Our regulations are based on pest risk assessments, survey data, and other science-based considerations. We analyze each amendment to the regulations concerning the admissibility of specific fruits and vegetables, and fruits and vegetables in general, independent of foreign export agreements. The amendments to the regulations in this rule are not a relaxation of our standards.
One commenter asked us to assure U.S. agricultural industries that the proposed amendments will not lessen the sanitary and phytosanitary standards of protection afforded to U.S. fruits and vegetables against infestation or disease from imports.
A major responsibility of the U.S. Department of Agriculture (the Department) is preventing the introduction and spread of plant pests; indeed, the Plant Protection Act requires the Department to carry out this responsibility. APHIS is responsible for implementing the regulations that carry out the intent of the Plant Protection Act. As part of this responsibility, we ensure that our resources are adequate to carry out our day-to-day functions such as verifying that agricultural commodities meet U.S. phytosanitary entry requirements at ports of entry and working with our cooperators to conduct plant pest surveys and eradication programs when necessary.
The amendments we are making to the regulations in this rule are not a reduction of sanitary and phytosanitary standards of protection. The amendments either strengthen or clarify the protection that the regulations provide. For instance, the amended packaging requirements for tomatoes from Spain, France, Morocco, and Chile will strengthen that protection by requiring that packaging safeguards remain intact upon arrival in the United States. Further, as discussed below, removing the criterion of “without risk” is intended to clarify the regulations to make them consistent with sound science.
Several commenters disagreed with our proposal to remove the “without risk” criterion from the regulations in § 319.56-2(e)(3) and (e)(4) that specify that certain fruits and vegetables may be imported from a definite area or district if that area or district is free of all or certain injurious insects (referred to elsewhere as pest-free areas) and the importation of the fruits and vegetables can be authorized “without risk.”
One concern commenters expressed with the removal of the “without risk” criterion from the regulations is that this amendment will broaden APHIS’ discretion without adequately ensuring that the phytosanitary security of our borders will be fully maintained. Several commenters were concerned that this amendment would allow trade or political issues to take precedence over the protection of U.S. agriculture.
Because the removal of the “without risk” criterion from the regulations is merely an administrative action to remove an impractical criterion, its removal will not affect APHIS’ discretion or our responsibility to guard against the introduction of pests. This change will not affect the purpose of our regulations—to protect the United States from the introduction or spread of plant pests—nor will it cause trade or political issues to take precedence over our responsibility. Further, the regulations in § 319.56-6 provide APHIS with discretion to refuse entry, require treatment, or require destruction of shipments of fruits and vegetables. In this rule, we are strengthening this requirement by specifying that imported fruits and vegetables must be fully disclosed at the port of first arrival.
Another concern raised by commenters was that commodities such as citrus from South Africa and Australia are currently being imported into the United States under the criterion of “without risk” and therefore our removal of that criterion would be misleading. We believe that this comment reinforces the need to remove the “without risk” criterion because it indicates that we need to clarify our regulations—no fresh agricultural commodity may be imported “without risk.” While the regulations prescribe inspection and, in some cases, as with citrus from South Africa and Australia, provide additional safeguards to reduce risk and guard against the introduction of quarantine pests, risk cannot be completely eliminated. The International Plant Protection Convention (IPPC) of the United Nations' Food and Agriculture Organization addresses this issue in the International Standards for Phytosanitary Measures (ISPM) No. 1, “Principles of Plant Quarantine as Related to International Trade.” The specific principle for managed risk states that “because some risk of the introduction of a quarantine pest always exists, countries shall agree to a policy of risk management when formulating phytosanitary measures.” Thus the fact that some risk does exist is an internationally recognized principle.
One commenter stated that the “without risk” language should not be changed because such a change is not specifically mandated in the Plant Protection Act and is contrary to § 412 (7 U.S.C. 7712) of the Act. Instead, this commenter stated, retaining the “without risk” criterion grants the appropriate importance to APHIS’ mandate to protect U.S. agriculture from quarantine pests that could cause substantial economic loss and other devastation to U.S. agriculture.
While the Plant Protection Act did not expressly direct the Department to remove the “without risk” criterion from the regulations, we disagree that the removal of the language is contrary to the Plant Protection Act. In fact, in its findings accompanying the Plant Protection Act, Congress stated in § 402(3) (7 U.S.C. 7701(3)) that “it is the responsibility of the Secretary to facilitate exports, imports, and interstate commerce in agricultural products and other commodities that pose a risk of harboring plant pests or noxious weeds in ways that will reduce, to the extent practicable, as determined by the Secretary, the risk of dissemination of plant pests or noxious weeds.” Given that the Act directs the Secretary to reduce risk “to the extent practicable”—and not to zero—we believe that removing the impractical and unrealistic “without risk” criterion from the regulations is consistent with the intent of Congress as expressed in the Plant Protection Act.
One commenter stated that omitting a definition of acceptable risk would lead to a regulatory process that will be less based on sound science and that APHIS is seeking to avoid defining what “without significant risk” means for future importations. Further, commenters voiced concern that we are not replacing the “without risk” criterion with a standard that indicates an acceptable level of risk. It is APHIS’ belief, which is based on sound science, that it is not appropriate to define an acceptable level of risk for all future imports. The risks associated with importations of fruits and vegetables vary depending upon the pest-commodity-origin complex. Further, the Plant Protection Act does not define the term “acceptable level of risk” or require the Secretary to define it, nor does the Plant Protection Act require the Secretary to prohibit imports unless he or she can conclude that there is zero risk of pest introduction. Instead, the Act gives the Secretary discretion to
The lack of a specific standard for an acceptable risk level will not lead to a regulatory process that will be less transparent or establish a system that is easily changed by outside parties as one commenter indicated. Removing the “without risk” criterion will not affect the rulemaking process. Any changes to the regulations will continue to be made using notice and comment rulemaking, which helps to ensure transparency. Further, the lack of a specific standard for an acceptable level of risk will not lead to a system that is easily changed by outside parties as we will continue to base our decisions on sound science.
One commenter linked the failure to address the standard of phytosanitary security to additional costs (
Another commenter stated that we should establish acceptable levels of risk based on the outcome of a case concerning the importation of citrus from Argentina,
One commenter stated that the “without risk” criterion protects the environment in that if a foreign pest outbreak occurred and the pest became established in the United States, the environment would be compromised due to pesticide spraying and other pest control methods. Although eradication of quarantine pests may require the use of pesticides and other control methods, removing the “without risk” criterion does not have the potential to harm the environment. The “without risk” criterion is impractical, and its removal will not have any impact on the environment. In the event of an outbreak, APHIS would continue to prepare any necessary environmental documentation under the National Environmental Policy Act and the Endangered Species Act in advance of any pesticide use and other pest control methods.
Two commenters voiced concern that we were proposing to replace the “without risk” criterion with the IPPC standard pertaining to pest-free areas, but this was not our intent. As stated in the proposed rule, we are removing the “without risk” criterion from § 319-56-2(e)(3) and (e)(4) because it is impossible to satisfy that requirement. We are not replacing the criterion with either a definition of acceptable risk or with the IPPC standard for pest-free areas. We proposed to adopt ISPM No. 4, “Requirements for the establishment of pest free areas,” as a replacement for the specific criteria for area freedom in § 319.56-2(f). While ISPM No. 4 specifies that one of the considerations in establishing a pest-free area is the “level of phytosanitary security required as related to the assessed level of risk, according to the pest risk analysis conducted,” this is not a deviation from our current practice of conducting a pest risk analysis for commodities not previously approved for importation.
We proposed to replace the specific criteria in § 319.56-2(f) for pest-free areas with the ISPM No. 4, “Requirements for the establishment of pest-free areas,” which would be incorporated by reference into the regulations.
One commenter claimed our statement that “[w]e believe that incorporating this standard by reference into our regulations would prevent the introduction of quarantine pests into the United States and provide requirements that are consistent with the IPPC” is unrealistic because the standard could not completely eliminate the risk of introducing pests. The commenter is correct that our adoption of the standard by itself would not eliminate the risk of introducing pests. The standard describes requirements for the establishment and use of pest free areas as a risk management option for phytosanitary certification, and our intent was to communicate our belief that using the standard to determine the pest-free status of an area would provide us with an effective risk management tool that, more so than our existing criteria for the establishment of pest-free areas that have been found in § 319.56-2(f), is consistent with internationally recognized standards.
One commenter opposed the use of the IPPC standard because it appears that APHIS is proposing to supercede the Federal government's rulemaking authority with blanket approval for the IPPC to determine U.S. sanitary and phytosanitary standards. According to the commenter, this change could result in deferring the establishment of risk criteria to an international body, which could be arbitrary and capricious and lack transparency and accountability, as well as be an abuse of discretion. Another commenter who disagreed with using the IPPC standard objected on the grounds that we would be abdicating our responsibilities to an international group that would not always be controlled by the best science.
In making this amendment to the regulations, we are not abdicating our rulemaking authority or responsibilities to the IPPC, nor are we deferring our establishment of risk criteria to that body. Any decision made regarding the pest-free status of an area in the context of our import requirements will continue to be made by APHIS, just as has been the case under the provisions of § 319.56-2(f) that ISPM No. 4 will replace. It is important to note that incorporating ISPM No. 4 by reference has the effect of making that standard, in its current form (
With respect to the issue of transparency raised by one of the commenters, we believe that our incorporation by reference of ISPM No. 4 will make our regulations more, and not less, transparent. The criteria in § 319.56-2(f) that we have used for recognizing pest-free areas make reference to surveys performed in accordance with requirements approved by the Administrator and phytosanitary requirements deemed by the Administrator to be at least equivalent to our own, but do not provide specific details regarding those survey and phytosanitary requirements. ISPM No. 4, on the other hand, provides both general and specific requirements for determination of pest-free areas, establishment and maintenance of pest-free areas, systems to establish freedom, phytosanitary measures to maintain freedom, checks to verify freedom has been maintained, and documentation and review.
Another commenter partly supported the reference to the IPPC standard but was concerned that stating that a country's program meets the requirements of the standard for a pest-free area is not entirely transparent. The standards are written broadly, and measures such as ad hoc monitoring, general surveillance, and specific surveillance vary from situation to situation. Only measures specifically applied to the identified pest risk should be used to support a statement that the appropriate level of protection has been attained.
We agree that the standards used to determine whether an area is pest free will vary. When we evaluate whether an area is pest free, we consider and apply the appropriate measures. We believe that the survey, data, research, pest risk assessment, and other elements that must be addressed under ISPM No. 4, which must be approved in each particular case by APHIS and which will be made available to the public for review before we make a final determination as to an area's pest free status, will provide for a transparent decisionmaking process and will ensure that measures specifically applied to the identified pest risks will be used to support our determinations.
Another concern expressed by a commenter was that incorporating this standard by reference would result in surrendering the survey for pests to the country of origin. Incorporating the IPPC standard for pest-free areas into the regulations will not affect the way that we approve pest surveys in the country of origin. Agricultural authorities in the country where the area is located will continue to conduct the surveys as they have done in the past, and the surveys will continue to be performed according to procedures approved by APHIS. Given that we will continue to approve the survey methodology and resulting data prior to determining whether an area is indeed pest free, APHIS’ role in ensuring that the surveys are valid and meet the requirements of the regulations will not be affected by this amendment to the regulations.
One commenter voiced concern that adopting the IPPC standard could be a prelude to establishing low prevalence pest areas that would be totally governed by the IPPC. We will not use this standard to establish low prevalence pest areas, let alone such areas that would be totally governed by the IPPC. The scope of ISPM No. 4 does not provide for the recognition of low prevalence pest areas; it is limited to the requirements for pest-free areas, which the standard defines, in part, as “an area in which a specific pest does not occur. * * *
One commenter suggested that we change the proposed language incorporating the IPPC standard by reference so that pest-free areas would not have to be added to our regulations through rulemaking before imports could be allowed from such areas. Specifically, he recommended that the Administrator of APHIS authorize administratively the importation of a fruit or vegetable under § 319.56-2(e)(3) or (4), whenever he or she determines that the fruit or vegetable is being imported from an area that satisfies the requirements of ISPM No. 4 for recognition as a pest-free area with respect to the pests of concern for that fruit or vegetable. We are considering the suggestion, and if we determine that making that change would be appropriate, we will propose it in a separate document published in the
In this final rule, we are not making any changes based on the comments received on incorporation by reference of ISPM No. 4. However, we are making two editorial changes. First, we are clarifying that the Administrator must determine that the area is free of the pest or pests in accordance with the criteria for establishing freedom found in ISPM No. 4. In the proposed rule, we stated that ISPM specifies
We proposed to amend § 319.56-2t to allow the importation of rambutan from Central America and Mexico. One commenter supported the importation of rambutan from Central American countries but questioned whether cold treatment or other treatment of rambutan was required. If treatment is required, the commenter stated, electrification, irradiation, vapor, hot water, or fumigation treatments would be preferable to cold treatment. Rambutan from Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama will be eligible to be imported under § 319.56-2t, which lists fruits and vegetables for which treatment is not a condition of entry. However, under § 319.56-6, rambutan, like any fruit or vegetable, may be subject to treatment if the inspector finds a pest of concern during inspection at the port of first arrival and determines that treatment is necessary. If a quarantine pest were to be found, an inspector would determine what action to take, including treatment, reexportation, or destruction of the shipment.
Another commenter requested more studies to support the importation of rambutan from Central America and Mexico. The commenter stated that fruit cutting for two seasons and the reliance on interceptions in passenger baggage and other information on which APHIS’ decision was based are insufficient evidence that rambutan is not a fruit fly host in Central America and Mexico.
We believe that the evidence presented in the pest risk assessment is sufficient to support our decision to allow the importation of rambutan from Belize, Costa Rica, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, and Panama. The research indicates that fruit flies that occur in Central America and Mexico are not likely to follow the pathway on undamaged rambutan fruit, and they are not reported as pests of rambutan in these regions. In the field study in which 47,188 fruits of 10 varieties were cut over two seasons, no Medfly was found. Another study that was conducted under laboratory conditions indicates that the Medfly was able to oviposit, but with very low pupation rate, in damaged fruit.
One commenter supported the importation of rambutan as well as other commodities from Honduras. He reported that Honduras would export approximately 1,500 metric tons of rambutan from the estimated 250 hectares of rambutan that will be in production in 2003. He also reported that there are more than 125 growers of rambutan in Honduras. We will include this information in the final regulatory flexibility analysis for this rule.
We proposed to amend § 319.56-2t to allow the importation of fennel from El Salvador, Guatemala, and Nicaragua. Commenters indicated that imports of fennel would harm U.S. fennel producers. The commenters reported that fennel is grown in California and Arizona in sufficient quantities to meet the demand for commercial fennel. Commenters also objected to the use of fennel seed data in the economic analysis instead of data for fennel leaves and stems and provided production data for two of the four California counties in which they stated fennel is produced.
We have included information provided by the commenters regarding domestic fennel production in this rule's final regulatory flexibility analysis. We were unable to find supporting or additional data, which could be because this commodity is a specialty crop. We have removed the data on imports of fennel seed from El Salvador from the final regulatory flexibility analysis because they do not apply to the importation of fennel leaves and stems. We also address effects on domestic producers in the final regulatory flexibility analysis.
Several commenters objected to the importation of fennel into the United States from El Salvador, Guatemala, Honduras, and Nicaragua based on their dissatisfaction with the pest risk assessment. The commenters voiced concern that the pest risk assessment contained insufficient detail concerning research conducted to identify all potential pests. Commenters questioned whether
We would like to point out that while the pest risk assessment was conducted to examine the pest risk associated with the importation of fennel from El Salvador, Guatemala, Honduras, and Nicaragua, we proposed to allow the importation of fennel from only three of those countries—El Salvador, Guatemala, and Nicaragua.
The research conducted for the pest risk assessment was complete and thorough. We conducted an exhaustive search of literature and reviewed our historical plant pest database and interception information. In addition to the literature sources cited in the pest risk assessment, we consulted more than 135 other sources. One of those sources, the Government of Honduras, indicated that
Some of the commenters voiced concerns that an interception from Guatemala of Lepidoptera species was not analyzed, referring to the note in the pest risk assessment that the absence of taxonomic information at the species level makes biological evaluations difficult. The interception of the Lepidoptera species was not further analyzed in the pest risk assessment as it was a single occurrence that was intercepted in fennel from Guatemala in 1996 with an inconclusive determination of quarantine status.
Several commenters were concerned about pests that were identified in the pest risk assessment as likely to follow the pathway. Table 2 of the pest risk assessment lists pests of fennel in El Salvador, Guatemala, Honduras, and Nicaragua that have been reported in scientific and regulatory literature. While table 2 lists 12 pests that are known to occur in these 4 Central American countries, only 1 of the 12 is a quarantine pest—
Several commenters recommended that the exporting country must prove that it has a system in place to ensure that pests are not transported in fennel shipments, rather than relying on APHIS inspections at the port of entry, because they are concerned that there are no indications that inspections are sufficient to prevent an infested shipment from entering the United States.
APHIS successfully uses inspection at the point of entry as the only phytosanitary measure needed to mitigate the pest risk posed by several commodities from various countries. Inspectors are trained to find pests in agricultural commodities. In 2002, APHIS inspectors intercepted 68,556 quarantine pests, and it is estimated that an equal number of nonquarantine pests were intercepted. As discussed above, no quarantine pests were identified in the pest risk assessment as occurring in fennel from El Salvador, Guatemala, and Nicaragua. Therefore, inspection at the port of entry mitigates the pest risk posed by the importation of fennel from El Salvador, Guatemala, and Nicaragua.
Several commenters expressed concern that the pest risk assessment did not address the impact on U.S. growers should any pest be introduced. The pest risk assessment is consistent with the guidance provided by the North American Plant Protection Organization (NAPPO), the IPPC, and APHIS’ Guidelines for Pathway-Initiated Pest Risk Assessments. The pest risk assessment examined pest risk associated with the importation into the United States of fresh leaves and stems of fennel from El Salvador, Guatemala, Honduras, and Nicaragua. Risk of introduction of pests was evaluated in qualitative terms of high, medium, and low. One of the risk elements that we considered in determining the consequences of introduction for
We proposed to amend § 319.56-2u to require that insect-proof containers remain intact during transit and be intact upon arrival in the United States. We also proposed an alternative packaging method of covering non-insect-proof boxes with insect-proof
One commenter objected to the proposed requirement that shipping containers remain sealed and intact until peppers from Israel arrive in the United States. The commenter relayed that the shipping containers transit Europe, where the shipping containers are opened to rearrange the boxes during transport to the United States. Thus the proposed seal on shipping containers transiting fruit-fly areas would not remain intact during transit from Israel to the United States.
The purpose of the packaging safeguards is to ensure that peppers shipped from Israel to the United States are protected from pests during all phases of their movement from the approved screenhouses. Our proposed requirements that the peppers be packed in either individual insect-proof cartons or in non-insect-proof cartons that are covered by insect-proof mesh or plastic tarpaulins that must arrive intact in the United States will remain unchanged. We are, however, removing the requirement that the shipping containers be sealed. Because the shipping containers are opened and the insect-proof cartons of peppers within the shipping container are transferred to another shipping container, we agree that the proposed requirements that shipping containers remain sealed at all times during the movement of peppers to the United States and that the seal be intact upon the arrival of the peppers in the United States are not feasible. Further, we believe that the certification on the phytosanitary certificate that the requirements of the regulations have been met, coupled with the requirement that the insect-proof packaging remain intact until the arrival of the peppers in the United States, will be adequate in protecting shipments of peppers from Israel from the infestation by pests during transport.
We proposed to amend § 319.56-2x to allow the importation of yellow pitaya from Colombia. We specified that yellow pitaya would have to undergo vapor heat treatment for the Medfly and the South American fruit fly,
We received four comments opposing the importation of yellow pitaya from Colombia into the United States. The commenters stated that the pest risk assessment is inadequate because it does not thoroughly evaluate pests of concern. Commenters indicated that the pest risk assessment should consider pests of the stem and root in addition to pests of the fruit because portions of the stem and root would accompany the fruit during shipment. Specific pests of concern provided in the comments are
We did not consider pests of the stem and root in the pest risk assessment because stem and root portions will not accompany the yellow pitaya fruit during shipment from Colombia to the United States. In Colombia, commercially produced fruit of yellow pitaya are harvested and shipped without attached stem or root portions. We conducted a thorough search of worldwide literature and did not find mention of “
Commenters noted the drastic decline in surface area planted to pitaya in Colombia between 1990 and 1996 reported in the document “Vapor heat treatment for pitaya fruit infested with eggs and larvae of Mediterranean fruit fly.” Colombia reported 1,016.95 ha of pitaya in 1990, and in 1996, there was only 255.4 ha. They stated that Dr. Yosef Mizrahi of Israel reported that a strain of
We disagree that the decline in yellow pitaya was attributed to
One commenter pointed out that, according to the pest risk assessment, action may be taken and further risk assessment may be conducted for certain pests if those pests are found in shipments of yellow pitaya. The commenter stated that APHIS must take the appropriate steps prior to allowing the importation rather than after the shipment arrives in the United States. Another concern was that some of the pests that were not further analyzed in the pest risk assessment were eliminated from consideration for reasons other than research evidence.
Shipments are subject to inspection at the port of entry and will be denied entry if pests of concern are intercepted. We do investigate pest problems associated with commodities in their countries of origin during our pest risk assessments. Our current method of performing pest risk assessments is to do an exhaustive search of literature and review our historical plant pest database and interception information. When available, we also use information from other sources, and occasionally conduct onsite investigations in proposed export areas. The pest risk assessments are science-based and largely dependent upon literature on plant pest problems in countries of origin. This literature is primarily investigative findings published by scientists. Our experience has shown that if a pest causes damage to an economic crop, the scientific community investigates the pest's biology and extent of pest damage in prescribing remedial actions.
Another concern raised by commenters was that APHIS’ approval for the importation of yellow pitaya from Colombia would be based on the mitigation provided by a vapor heat treatment for Medfly, but that the pest risk assessment does not address the protection mechanisms against the other pests. In addition, some commenters stated that the pest risk assessment is
Our pest risk assessment was conducted in accordance with NAPPO and IPPC guidelines, which are referenced in our pest risk assessment. ISPM No. 11, “Guidelines for Pest Risk Analysis for Quarantine Pests,” describes three stages of pest risk analysis: Initiation, risk assessment, and risk management. The pest risk assessment for yellow pitaya from Colombia satisfies the requirements for the first two stages, initiation and risk assessment, by determining if a pest is a quarantine pest and evaluating the risk associated with its introduction via pitaya imported from Colombia. The pest risk assessment is qualitative, where risk is expressed in descriptive terms (high, medium, and low), rather than quantitative, where risk would be expressed in probabilities or frequencies. In addition to reflecting a qualitative risk assessment, our use of terms, such as “may” and “likely” reflects the fact that we cannot completely eliminate risk. Using more absolute terms, such as “will” and “definitely,” would be inaccurate. The pest risk management stage is not part of the pest risk assessment document that we prepared.
Pest risk management involves the process of reducing the risk of introduction of a quarantine pest and leads to a decision of whether to allow the importation of the commodity, and under what conditions. The conditions for pest risk management for imports of yellow pitaya fruit from Colombia were provided in the proposed rule. The risk management approach used to kill the internal feeders—
One commenter expressed concern that pesticides used on the pitaya crop in Colombia would not be allowed on similar fruit in the United States. The U.S. Food and Drug Administration (FDA) samples and tests imported fruits and vegetables for pesticide residues. If residue from a pesticide that is not approved in the United States is found, the FDA will deny the shipment's entry into the United States.
The commenter also disagreed with the statement in the pest risk assessment that the pesticides used on pitaya in Colombia would mitigate the pest risks. He questioned whether evidence exists that Colombia would administer the pesticides to all shipments of pitaya.
Colombia is a major producer of yellow pitaya and successfully exports fresh yellow pitaya fruit to dozens of countries. While any pesticides applied may help manage the risk of external pests, the risk management approach used for external pests is inspection. As discussed above, however, an inspector may refuse entry of a shipment if it is infested.
We proposed to amend § 319.56-2v to add specific geographic areas to that section's list of areas in Australia from which citrus may be imported. One commenter recommended that we distinguish the Parish of Onley in the Shire of Mildura, Victoria, from the geographic subdivisions called “hundreds.” As the Parish of Onley is not one of the hundreds, we have changed § 319.56-2v(a)(1) in this final rule to distinguish the Parish of Onley from the listed hundreds. Data were submitted showing that the Parish of Onley and the additional hundreds meet the criteria for pest-free areas.
Another commenter stated that APHIS is proposing to allow new Australian production areas to export citrus to the United States but does not define its process for overseeing the continued freedom of those production areas from quarantine pests and diseases. Before a country conducts a survey, APHIS approves the survey protocol used to determine pest-free status. Once a free area is established, APHIS verifies that the area remains pest free. In addition to notification from the country concerning the maintenance of pest-free areas, we have several methods to verify that an area remains pest free. APHIS personnel are stationed overseas to evaluate the effectiveness of the survey and regulatory programs that the country of origin uses to maintain the pest-free areas. Another method is through agriculture inspection at the port of entry, as any findings of quarantine pests could indicate that an area is no longer a pest-free area. In the case of citrus from Australia, the regulations provide that in the event that surveys detect quarantine pests in the designated free areas, the citrus could be cold treated, if a treatment is available for the pest of concern, and remain eligible for importation into the United States.
The commenter correctly indicated that we do not define the process or our role in verifying the status of pest-free areas. Therefore, we are amending § 319.56-2(f) by stating that APHIS must approve the survey protocol used to determine pest-free status, and pest-free areas are subject to audit by APHIS to verify their status.
A commenter stated that APHIS is rewarding Australian producers with increased U.S. market access at the same time that Australia is dramatically restricting American growers from exporting to Australia. Our proposal and decision to allow imports of citrus from additional areas in Australia were based on data that indicated that the areas are free of destructive fruit flies.
One commenter correctly indicated that the value of citrus that Australia exported was underreported in the initial regulatory flexibility analysis at $37,000. We will adjust the final regulatory flexibility analysis to show $108.7 million as the value of Australian citrus exports for 2001.
We proposed to amend § 319.56-2dd to allow the importation of tomatoes from Australia. We specified certain phytosanitary conditions under which the importation would be allowed to manage the risks presented by several species of fruit flies, loopers, worms, and caterpillars. One commenter recommended specific changes to these phytosanitary requirements.
First, the commenter recommended removing the requirement that McPhail traps be used and replacing that requirement with “fruit fly traps of an approved type” because specifying the type of fruit-fly trap is too restrictive. In response to this comment, we are removing the specification in § 319.56-2dd(e)(2) that the fruit-fly traps be McPhail traps and specifying instead that the traps be APHIS approved. As long as the regulations require the use of an APHIS-approved fruit-fly trap, phytosanitary security will not be affected.
Second, the commenter recommended rephrasing the wording used for the rate that fruit-fly traps must be set. The proposed rule stated that “in all areas outside of the greenhouse and within 8 kilometers of the greenhouse, fruit-fly traps must be placed at the rate of at least four per square kilometer.” The commenter reported that the current trapping grid in production areas in the fruit fly exclusion zone is based on a 1 km grid with a trap set at each corner
Third, the commenter recommended that the proposed requirement stating that “outside of a registered greenhouse, if one fruit fly of any type is found within 2 kilometers, trap density and frequency of trap inspection must be increased to detect a reproducing colony” be changed to “outside of a registered greenhouse, if one fruit fly of the types specified in this notice is found within 2 kilometers of the facility, * * * ” Because this change would not affect the protection that the regulations provide, we have changed the requirement in § 319.56-2dd(e)(4) to state that the detection of one fruit fly of the species specified in § 319.56-2dd(e) would trigger an increase in trap density and inspections. In addition, we have made editorial changes to clarify that the threshold for cancellation of exports is the capture of two Medflies or three of the same species of
Finally, the commenter suggested including certain specifics in the operational workplan between the country of origin and the United States and excluding that information from the regulations. For example, the proposed rule would require that “Capture of two Medflies or three of the same species of
For the same reasons as discussed above under the heading “Peppers from Israel,” we are removing the proposed requirement for the sealing of shipping containers for tomatoes from Spain, France, Morocco and Western Sahara, and Australia (§ 319.56-2dd(a), (b), (c), and (e), respectively).
Another commenter requested that we review the use of “pink” and “red” to describe the ripeness of tomatoes in general. He contended that these terms are obsolete and potentially harmful with production of heirloom tomatoes of many different colors. While the regulations concerning the importations of tomatoes from Australia do not require that they be pink or red, the regulations do include this provision for certain other countries. If the pink or red criterion should become an issue with those importations, we will evaluate the adequacy of the pink or red criterion. However, at this time, we are not making any changes in response to this comment.
We proposed to allow the importation of persimmons from the Republic of Korea under the conditions set forth in § 319.56-2kk. One commenter correctly stated that the proposed shipping restriction that would prohibit the entry of persimmons from the Republic of Korea into Hawaii, Puerto Rico, the Virgin Islands, and Guam would be unnecessary because the pest risk assessment was conducted for all areas of the United States. In addition, the commenter noted that persimmons from the Republic of Korea are currently imported into Guam. In response to this comment, we are removing the shipping restriction for persimmons from the Republic of Korea.
Another commenter objected to the importation of persimmons from the Republic of Korea, stating that APHIS is proposing an inadequate method of enforcement for ensuring that quarantine pests are controlled within production areas. Further, the commenter argued that establishing the orchard, which could be defined in many different ways, as the unit of reference for inspection and refusal of imports has no scientific justification.
We are allowing the importation of persimmons from the Republic of Korea into the United States under, among other things, the condition that the orchard where they were grown was inspected and found free of quarantine pests by the Republic of Korea's NPPO. After harvesting and before packaging a shipment of persimmons, the Republic of Korea's NPPO must inspect the shipment for quarantine pests, and if no pests are found, they must declare that on a phytosanitary certificate.
When the shipment enters the United States, it will be inspected again by a U.S. inspector who will decide whether to allow or refuse entry of the shipment. Costs associated with refusal of a shipment would be borne by the exporter; therefore, the exporter has added incentive to comply with the regulations. Traceback to an orchard would be accomplished through records kept by the Republic of Korea's NPPO. We regulate at the orchard level in many of our commodity import regulations, because doing so provides us with a meaningful way to eliminate products from the import chain when we identify problems;
However, in response to this comment, we are making changes to clarify the regulations. In § 319.56-1, we are adding a definition of the term “place of production” that is consistent with the current IPPC definition. The definition for the term “place of production” is “any premises or collection of fields operated as a single production or farming unit. This may include a production site that is separately managed for phytosanitary purposes.” Because the definition of the term “place of production” includes the term “field” and “production site”, we are also including definitions of those terms. The term “field” is defined using the IPPC definition of “a plot of land with defined boundaries within a place of production on which a commodity is grown.” The term “production site” is defined as “a defined portion of a place of production utilized for the production of a commodity that is managed separately for phytosanitary purposes. This could include the entire place of production or portions of it. Examples of portions of places of production are a defined orchard, grove, field, or premises.” In § 319.56-2kk, which concerns persimmons from the Republic of Korea, we are replacing the first occurrence of the word “orchard” with “production site, which is an orchard.”
One commenter voiced concerns about added provisions to allow the entry of cold treated commodities when failures of this treatment protocol have yet to be completely addressed. This commenter stated that (1) although the cold treatment for Medfly has been lengthened, the suspected operational
In general, when pests are intercepted following treatment, APHIS investigates possible causes and responds appropriately. In the specific case of multiple live Medfly interceptions in clementines from Spain, APHIS halted clementine imports until we evaluated the situation, and the Secretary determined that it was no longer necessary to prohibit the importation or interstate movement of the fruits if a lengthened cold treatment was applied, along with other safeguards. In conducting our evaluation, we reviewed the cold treatment protocols for Medfly. APHIS’ review of the cold treatment applied to the clementine shipments that contained live Medfly larvae yielded no evidence that the treatment was improperly applied. In an interim rule (67 FR 63529-63536, Docket No. 02-071-1, effective and published October 15, 2002), we extended the duration of cold treatment for Medfly and added a requirement that inspectors will sample and cut fruit from each shipment cold treated for Medfly to monitor the effectiveness of the cold treatment.
In response to interceptions of the false codling moth from cold treated citrus in South Africa, we have taken three actions to help ensure fruit infested with false codling moth do not enter the United States with cold treated fruit. First, fruit entering through preclearance programs will be rejected before treatment if false codling moth is found. Second, additional fruit cutting is being instituted in the preclearance program. Third, at the ports of entry, fruit cold treated for false codling moth has been moved to the highest risk level—the number of fruit being cut on arrival is 150 per container or 1,500 for bulk shipments.
In § 319.56-3, we proposed to add provisions that oral permits may be issued in cases where no other importations are considered and the commodity is admissible with only inspection. One commenter questioned the ability to conduct tracebacks and keep records under the proposed oral permit provision. Specifically, the commenter asked how the oral request is documented, what form an oral request needs to be in, for what purposes does the oral request need to be made, and if an oral request can be denied, what would be the reasons for denial. The commenter stated that APHIS is also easing the burden upon importers in obtaining these permits by allowing oral permits to be satisfactory in securing inspection.
Allowing oral permits is a standard practice for noncommercial fruits or vegetables at the U.S. ports of entry. It is APHIS' policy to allow oral permits on a daily basis for fruits and vegetables brought in through passenger baggage. For these noncommercial shipments, no application is necessary. While oral permits are also issued to importers who are first-time importers of commercial shipments, the importers must apply in writing, which provides documentation of the importation as well as proof that the importers were informed of the requirements. Since this is a current practice, we do not view the amendments to the regulations as easing the burden upon importers. Instead, the amendments to the permit regulations will clarify and update our procedures.
As is the case with a fruit or vegetable that is imported with a written or electronic permit under § 319.56-6, entry of any fruit or vegetable that is being considered for importation under an oral permit would be denied if the inspector finds evidence of a pest or disease. The issuance of oral permits will not influence the requirement for a permit. Regardless of the form—oral, written, or electronic—a permit is required. Written or electronic permits are required from importers who routinely ship commercial products to the United States.
Based on the questions posed by the commenter, we are making several changes to further clarify the permit provisions. In the definitions in § 319.56-1 and throughout § 319.56-3, we have changed “specific permit” to