Revision of Fruits and Vegetables Import Regulations
We are revising and reorganizing the regulations pertaining to the importation of fruits and vegetables to consolidate requirements of general applicability and eliminate redundant requirements, update terms and remove outdated requirements and references, update the regulations that apply to importations into territories under U.S. administration, and make various editorial and nonsubstantive changes to regulations to make them easier to use. We are also making substantive changes to the regulations, including: Establishing criteria that, if met, will allow us to approve certain new fruits and vegetables for importation into the United States and to acknowledge pest-free areas in foreign countries more effectively and expeditiously and doing away with the practice of listing in the regulations specific commodities that may be imported subject to certain types of phytosanitary measures. These changes are intended to simplify and expedite our processes for approving certain new imports and pest-free areas while continuing to allow for full public participation in the processes. This rule revises the structure of the fruits and vegetables import regulations and establishes a new process for approving certain new commodities for importation into the United States. It does not, however, allow the importation of any specific new fruits or vegetables, nor does it alter the conditions for importing currently approved fruits or vegetables except as specifically described in this document. To the extent that our trading partners consider the length of time it takes to conduct the rulemaking process a trade barrier, these changes may facilitate the export of U.S. agricultural commodities by reducing that time for fruits and vegetables that meet this rule's criteria. The changes do not alter the manner in which the risk associated with a commodity import request is evaluated, nor do they alter the manner in which those risks are ultimately mitigated.
1 action from February 2005
Table of Contents Back to Top
- EFFECTIVE DATE:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- Changes to the Proposed Rule
- Pest-Free Areas
- APHIS' Mission
- Eligible Measures for Notice-Based Approach
- Information Provided to Public
- Operations in Other Countries
- Stakeholder Participation
- Benefits of Implementing Notice-Based Approach
- APHIS' Resources
- Import Requirements for Specific Commodities
- Pest Risk Analyses
- Insect-Proof Packaging
- Use of Terms
- Frozen Fruit and Quick Freezing
- General Comments
- Additional Changes
- Changes to the Regulations Since the Publication of Our Proposal
- Executive Order 12866 and Regulatory Flexibility Act
- Summary of Cost-Benefit Analysis
- Summary of Regulatory Flexibility Analysis
- Objectives of and Legal Basis
- Significant Issues Raised by Public Comments
- Description and Estimate of Small Entities
- Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities
- Executive Orders 12988 and 13132
- National Environmental Policy Act
- Paperwork Reduction Act
- E-Government Act Compliance
- Lists of Subjects
- PART 305—PHYTOSANITARY TREATMENTS
- PART 319—FOREIGN QUARANTINE NOTICES
- Subpart—Fruits and Vegetables
- Subpart—Fruits and Vegetables
- PART 352—PLANT QUARANTINE SAFEGUARD REGULATIONS
EFFECTIVE DATE: Back to Top
August 17, 2007.
FOR FURTHER INFORMATION CONTACT: Back to Top
Regarding the commodity import request evaluation process, contact Mr. Matthew Rhoads, Program Manager, Planning, Analysis, and Regulatory Coordination, PPQ, APHIS, 4700 River Road Unit 141, Riverdale, MD 20737; (301) 734-8790.
Regarding import conditions for particular commodities, contact Ms. Donna L. West, Senior Import Specialist, Commodity Import Analysis and Operations, PPQ-PRI, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737; (301) 734-8758.
SUPPLEMENTARY INFORMATION: Back to Top
Background Back to Top
Under the regulations in “Subpart—Fruits and Vegetables” (7 CFR 319.56 through 319.56-8, referred to below as the regulations or the fruits and vegetables regulations) the Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA or the Department) prohibits or restricts the importation of fruits and vegetables into the United States from certain parts of the world to prevent plant pests from being introduced into and spread within the United States.
On April 27, 2006, we published in the Federal Register (71 FR 25010-25057, Docket No. APHIS-2005-0106) a proposal  to amend the regulations by revising and reorganizing the regulations pertaining to the importation of fruits and vegetables to consolidate requirements of general applicability and eliminate redundant requirements, update terms and remove outdated requirements and references, update the regulations that apply to importations into territories under U.S. administration, and make various editorial and nonsubstantive changes to regulations to make them easier to use. We also proposed to make substantive changes to the regulations, including: (1) Establishing criteria within the regulations that, if met, would allow us to approve certain new fruits and vegetables for importation into the United States and to acknowledge pest-free areas in foreign countries more effectively and expeditiously; (2) doing away with the practice of listing specific commodities that may be imported subject to certain types of phytosanitary measures; and (3) providing for the issuance of special use permits for fruits and vegetables.
We solicited comments on our proposal for 60 days ending on July 26, 2006. On August 1, 2006, we published a document in the Federal Register (71 FR 43385, Docket No. APHIS-2005-0106) reopening the comment period for our proposed rule until August 25, 2006. We received 49 comments by the close of the extended comment period. The comments were from representatives of State and foreign governments, industry organizations, importers and exporters, distributors, and private citizens. The majority of the commenters supported the proposed rule in terms of improving transparency and reorganizing the structure of part 319; however, some commenters also raised questions or concerns about our proposal, which are discussed below by topic.
Changes to the Proposed Rule
We made changes to the proposed rule which we will note in this paragraph as an easy reference for the reader. We established a notice-based approach for pest-free areas, added “commercial consignments only” as one of the measures eligible for the notice-based approach, removed proposed requirements that would have provided for the issuance of special use permits, and made several other nonsubstantive editorial and technical changes to our proposed rule. The reasons for those changes are discussed later in this document.
Proposed § 319.56-5 included provisions that would govern our recognition of pest-free areas. In those proposed provisions, we stated that after determining that an area was free of a specified pest, we would publish a notice in the Federal Register announcing that the area meets the criteria for pest freedom in § 319.56-5. Several commenters raised concerns with this approach because pest-free areas would be recognized by APHIS without an opportunity for public comment. The commenters asked that we allow for public input before taking such an action.
We agree with the commenters and have amended § 319.56-5(c) in this final rule to provide for a 60-day comment period following publication of a notice announcing that an exporting country has provided us with the documentation required by the regulations to support a determination that an area is free of a specified pest and that we have completed our evaluation of the request. Only after any comments received in response to the notice have been carefully considered and our initial conclusion affirmed, would we publish a notice recognizing the area's freedom from the particular pest. Removal of an area's pest-free status will continue to be effective immediately.
One commenter asked if APHIS will develop standards or requirements that countries will need to comply with when establishing pest-free areas. A second commenter stated that the proposed provisions were not strenuous enough in setting out how a pest-free area is identified and confirmed and relied too heavily on participants in the source country.
A country seeking APHIS recognition of a pest-free area must submit official documentation that establishes the pest-free status of that area in accordance with the criteria found in International Standards for Phytosanitary Measures (ISPM) No. 4 “Requirements for the Establishment of Pest Free Areas,” which is incorporated by reference into the regulations. Further, the country must provide us with the survey protocol used to determine and maintain pest-free status, as well as protocols for remedial actions to be performed upon detection of a pest. Assembling the documentation necessary to address the criteria of ISPM No. 4 and designing the required survey and response protocols is the responsibility of the national plant protection organization (NPPO) of the requesting country; we believe this is entirely appropriate and is not at all an indication of undue reliance on the requesting country. We note in this regard that the regulations provide that the submitted protocols require APHIS approval before an area would be recognized as pest free and that pest-free areas are subject to audit by APHIS to verify their status.
One commenter asked if we could presume that a pest was absent or had always been absent if there are no records of the pest's presence in any pest surveillance data.
If the pest surveillance data referred to by the commenter were collected using accepted and reliable methods and covered a reasonable time period, it is reasonable to expect that we could consider those data as supporting a claim of pest freedom. We would not, however, make a determination on the basis of those data alone; as noted in our response to the previous comment, there are several factors that must be addressed before we will recognize an area as free from a particular pest.
Two commenters expressed the opinion that APHIS' mission has shifted from trying to prevent the introduction of foreign pests and diseases into the United States to one which enables the implementation of trade agreements that could have negative impacts on domestic producers. One of those commenters added that responding to foreign countries' claims, increasing the supply of foreign commodities, and increasing the variety of commodities in the United States are not part of APHIS' mission. Three other commenters stated that expediting and simplifying rulemaking does not correspond with APHIS' mission to safeguard American agriculture. The commenters stated that APHIS was not justified in proposing the notice-based approach.
APHIS' mission is to protect the health and value of American agriculture and natural resources, and we remain focused on preventing the introduction of pests and diseases into the United States. Without the activities that APHIS undertakes to protect America's animal and plant resources from agricultural pests and diseases, threats to our food supply and to our Nation's economy would be enormous. In recent years, the scope of APHIS' protection function has expanded beyond pest and disease exclusion and management. Because of its technical expertise and leadership in assessing and regulating the risks associated with agricultural imports, APHIS has an expanded role in the global agricultural arena. Now, the Agency must also respond effectively to other countries' animal and plant health import requirements and secure the acceptance of science-based standards that ensure America's agricultural exports, worth over $50 billion annually, are protected from unjustified trade restrictions. Nonetheless, APHIS has finite resources, and we must explore and implement proven and prudent measures to improve the regulatory process in order to allow us to allocate our available resources more effectively and to better address new risks as they emerge. We are convinced that simplifying the administrative process for dealing with low-risk commodity import issues will allow us to improve our effectiveness in protecting the plant health of American agriculture.
Eligible Measures for Notice-Based Approach
In the proposed rule, we noted that pest risk analyses for the importation of new commodities often consider only the risks posed by commercially produced and shipped fruit, and that noncommercial shipments may pose an entirely different pest risk than commercial shipments. For that reason, the regulations have provided that many fruits and vegetables could only be imported in commercial shipments, and the table in paragraph (a) of proposed § 319.56-13, “Fruits and vegetables allowed importation subject to specified conditions,” included a number of articles for which “commercial shipments only” was the only specified condition. We were open to the idea of including “commercial shipments only” as one of the designated phytosanitary measures listed in § 319.56-4 and specifically solicited comment on the subject.
We received two comments on the addition of “commercial shipments only” as a designated measure, both of which supported the idea. We have concluded that this approach has merit and we have added this measure as one of the measures eligible for the notice-based approach in § 319.56-4. (We note, however, that in the regulatory text of this final rule, we refer to “consignments,” rather than “shipments.” In our proposed rule, we discussed replacing the term “shipment” with “consignment,” but that change was not reflected consistently throughout the proposed rule. The terms commercial consignment, consignment, and noncommercial consignment are all defined in § 319.56-2 in this final rule, as they were in the proposal.)
In our proposal, we stated that if the notice-based process was adopted for use by APHIS, we would remove from the regulations those listed commodities that are currently approved for importation subject only to one or more of the designated measures. In keeping with that intent and to reflect our addition of “commercial consignments only” to the list of designated measures, we have amended the list in § 319.56-13(a) in this final rule by removing those articles that had been listed in the proposed rule for which “commercial shipments only” was the only specified condition. Those articles we have removed in this final rule, like other articles omitted from the proposed regulations by virtue if their being subject only to one or more designated measures, will continue to be listed in APHIS' fruits and vegetables manual, and the documentation supporting their approval will be made available on the Internet.
One commenter stated that he did not support the notice-based system because he believed that the determination as to which commodity import requests could be addressed using the notice-based system and which must be addressed through rulemaking is a subjective one.
We strongly disagree with this commenter. After we receive a request from a foreign government, we will conduct a pest risk analysis. If the pest risk analysis finds that the commodity can be imported under one or more of the mitigation measures eligible for the notice-based approach, then we will follow the notice-based process. If we find that additional measures are required, then we will follow the rulemaking process.
One commenter stated that we did not provide enough information as to why the conditions we listed in the proposed rule warrant the notice-based process.
We designed this notice-based system to target commodities that will require mitigations that are widely accepted by plant health experts and have a proven track record of efficacy. As stated previously, APHIS is a regulatory agency that has finite resources, and we have been exploring ways to improve the regulatory process for several years. The notice-based process will simplify the administrative process, while having no adverse effects on the scientific rigor of our analysis, the transparency of the process, or the public's ability to comment and participate in the process.
Two commenters asked that we clarify that rulemaking will be required if the pest risk analysis process determines that a systems approach is necessary.
A systems approach utilizes a series of risk mitigation measures intended to individually and cumulatively reduce pest risk. Such measures include sampling regimens, pest surveys, packing requirements, and other measures determined to be necessary to mitigate the pest risk posed by the particular commodity. By this definition, a systems approach could be eligible for the notice-based process if the system consists only of the designated measures we have determined qualify for the notice-based process; e.g., if a commodity requires origin from a pest-free area, pre-export inspection and certification, an approved post-harvest treatment, and inspection at the port of arrival in the United States. However, if additional mitigations such as field pest surveys, packinghouse safeguards, etc., were required, the commodity would not be eligible for the notice-based process.
One commenter asked how APHIS will consider approving additional measures for the notice-based process in the future.
Trading partners may petition us requesting specific additional measures to be included in the notice-based process and we would consider those requests at that time, or we may propose additional measures on our own initiative. Any additions to the list of designated measures would occur only through rulemaking. If we believe that additional measures should be eligible for the notice-based process, we would develop a new proposal, publish it in the Federal Register for comment, and follow with a final rule explaining our decision.
One commenter stated that we should consider adding systems approaches as one of the measures eligible for the notice-based process, especially in cases where similar species of fruits and vegetables are involved, or for which there is already an existing systems approach in a country. The commenter also asked about including places and sites of production that are free from specific pests and low pest prevalence areas in the notice-based approach.
We have chosen to initiate this new process with basic requirements and phytosanitary measures that are widely accepted and have a proven track record of efficacy, but may consider making the measures requested by the commenter part of the notice-based process in the future.
Information Provided to Public
On June 19, 2001, we published a notice in the Federal Register (66 FR 32923-32928, Docket No. 00-082-1) describing the procedures and standards that govern the consideration of import requests by the Agency's Plant Protection and Quarantine (PPQ) programs. That notice was published in response to a specific direction in sec. 412(d) of the Plant Protection Act (7 U.S.C. 7712(d)). One commenter stated that APHIS never published a followup to that notice and that the notice did not comply with all of the directives in the Plant Protection Act.
We revisited our June 2001 notice and reviewed the elements we were directed to address by sec. 412(d), and we believe, as we did at the time it was published, that our notice addressed all the elements specified in the Plant Protection Act. While we did not publish a document that formally responded to the comments we received on the notice, we have taken actions consistent with the recommendations made in some of those comments, such as developing and publishing amendments to our fruits and vegetables regulations, establishing a peer review system, and establishing regulations that govern the submission of import requests (see 7 CFR 319.5). We are in the process of developing a follow-up notice to our June 2001 notice that will offer an updated description of the procedures that govern our consideration of import requests. We will publish that notice in a future edition of the Federal Register.
Several commenters requested that APHIS routinely provide more information to the public in the form of country-specific operational work plans, internal communications within the Agency, and communications between APHIS and the petitioning country. One commenter specifically requested that we include country-specific work plans in our pest risk analyses as to allow for the public to comment on the work plans as well.
The operational work plans referred to by commenters (also known as bilateral work plans) are agreements between PPQ, officials of the NPPO of the foreign government involved, and, when necessary, foreign commercial entities that specify in detail the application of phytosanitary measures that will comply with our regulations governing the import or export of a specific commodity. An operational work plan is not finalized until after the final rule, or in the case of the notice-based approach, a final notice, has been published. As a longstanding matter of policy, APHIS does not make operational work plans available for public comment, but copies can be obtained by request. A more detailed description of how bilateral work plans are developed and used by APHIS can be found in a notice we published in the Federal Register on May 10, 2006 (71 FR 27221-27224). With respect to the suggestion that we routinely publish internal APHIS communications and bilateral communications between APHIS and foreign NPPOs, we strongly believe that it would not be appropriate or constructive. We must of course, communicate very clearly to the public the basis for our decisions. We will present our pest risk analyses and other documents supporting our regulatory decisionmaking in a manner that provides the public with a complete picture of what led to our decision. Furthermore, we will continue to answer questions and share additional background information whenever possible in response to specific requests. There will be no substantive alteration of the public's opportunity to review and comment on our conclusions.
One commenter asked how foreign governments could obtain the manual that includes the lists of names and production areas of enterable fruits and vegetables.
The manual, “Fresh Fruits and Vegetables Import Manual,” can be viewed on the Internet at http://www.aphis.usda.gov/import_export/plants/manuals/ports/downloads/fv.pdf.
In our proposed rule, we stated that we were in the early stages of converting APHIS' fruits and vegetables manual into a searchable database that will allow interested persons to search by commodity or by country, and that will list clearly the conditions that apply to each particular commodity from a specified country. One commenter asked when the import database will be available and how often it will be updated.
Our goal is to have the system operating as soon as possible after the publication of this rule. The import database will be updated whenever the fruits and vegetables manual is updated. In the meantime, a searchable database is currently available at: https://manuals.cphst.org/q56/Q56Main.cfm.
Operations in Other Countries
One commenter asked that we provide an outline of what information we would require from a foreign country to process an import request.
As noted previously, we have established regulations in § 319.5 that govern the submission of import requests. Those regulations provide that persons who wish to import plants, plant parts, or plant products that are not allowed importation under the conditions in part 319 (including the fruits and vegetables regulations) must file a request with APHIS in order for us to consider whether the new commodity can be safely imported into the United States. The completed request must address, among other things, questions about the party submitting the request, about the commodity proposed for importation into the United States, the proposed end use of the imported commodity (e.g., propagation, consumption, milling, decorative, processing, etc.), shipping information, description of pests and diseases associated with the commodity, and current strategies for risk mitigation or management in order for us to consider their import requests.
Several commenters questioned the ability of all foreign countries to provide all the data necessary for the preparation of pest risk analyses. The commenters stated that APHIS should be required to provide an assessment of the quality of the data provided or a description of the effort that APHIS had to expend to gather the necessary data so as to better allow stakeholders to assess the relative comprehensiveness of the data.
It is APHIS' responsibility to ensure we have a sufficient and reliable body of data to enable us to prepare an analysis that provides an accurate picture of pest risk. In some cases, the NPPO or other entity making the request may provide a draft pest risk analysis along with their submission; in such cases, that pest risk analysis is subject to rigorous review by APHIS to verify the accuracy of the information. In other cases, APHIS will prepare a draft pest risk analysis using the information described above that is required by the regulations in § 319.5. In either case, we will conduct a literature search, examine interception records, and perform site visits as appropriate. All of this information will be used in preparation of the pest risk analysis and will be made available for public comment. We expect that stakeholders and other reviewers will focus on the content of the pest risk analysis and the comprehensiveness and quality of the data used in its preparation, rather than on a report as to the level of effort that went into its preparation.
One commenter stated that the pest risk analysis should contain a report that the NPPO of the exporting country has the resources, experience, staff, capability, and willingness to do the work to prevent pests and diseases from entering the United States. The commenters asked specifically how APHIS will determine that the NPPO has adequate and competent resources available to effectively carry out prescribed mitigation measures.
Our past experiences with an NPPO and the information gained through site visits allow us to determine if an exporting country's NPPO will have the appropriate staff and resources to carry out the actions it would need to comply with particular mitigation requirements; if it does not, then we would explore alternative mitigation measures or, if none were available, deny the import request. It would be an empty gesture if we were to approve the importation of a commodity subject to risk mitigation requirements that the exporting country was unable to meet effectively, just as it would be a failure of risk management from our perspective to assign risk mitigation requirements that we did not expect could be met or did not conclude would be met.
One commenter stated that APHIS assumes that NPPOs are similar to each other and that the pests and diseases are the same or similar and can be addressed with similar mitigation measures. The commenter stated that when assessing a country's risk, we should factor in resources that are available and past experience with the organization.
We disagree strongly and can assure all interested parties that APHIS makes no such assumptions. The commenter's suggestion appears to confuse risk assessment with the operational aspects of risk management. In the risk assessment phase, the risk presented by a particular commodity is assessed scientifically and objectively; the ability of an NPPO to undertake activities that will mitigate the identified risks does not become a factor until after the unmitigated risk has been assessed and risk management measures are being considered. At that point, we most certainly take an NPPO's capabilities into account when considering the import request. While we may require similar mitigation measures for the same commodity from two different locations when pest conditions and climate conditions in the two exporting countries are similar, we evaluate each import petition on an individual basis, taking into consideration the unique risks associated with the commodity and the efficacy, feasibility, and impacts of the risk mitigation options. As noted above, we evaluate very carefully the capability of the NPPO and its plant health infrastructure.
One commenter noted that proposed § 305.3(a) states that “all treatments approved under part 305 are subject to monitoring and verification by APHIS.” The commenter said that in the case of imports from Chile, that provision should not imply any additional actions will be required beyond those already performed by APHIS and Chile's Servicio Agricola y Ganadero (SAG) under current operational instructions for the existing preclearance program in Chile.
The provision pointed out by the commenter does not alter the existing preclearance program in Chile. We explained in the proposed rule that many sections of the fruits and vegetables regulations have required that treatments be monitored by an inspector, and that in establishing § 305.3(a), we were simply consolidating those requirements into a single new section.
Several commenters stated that the 60-day comment period APHIS would provide for pest risk analyses might not allow enough time for those outside of APHIS to conduct their own scientific review.
We note that the regulations would provide for a comment period of 60 days, which does not preclude us from extending the comment period when necessary.
Several commenters said that we can improve transparency by allowing stakeholders to become involved during the pest risk analysis process. Those commenters asked that we take comments from the public on our pest risk analyses during the drafting stage. One commenter asked that APHIS notify stakeholders at the time an import request is received. Two other commenters stated that the proposed rule, if adopted, would reduce or eliminate stakeholder input.
With respect to allowing the public to comment on pest risk analyses during the drafting phase, such a process would have a serious adverse impact on the timely preparation of pest risk analyses. We believe a process in which an analysis is prepared, reviewed, and brought to a point where wider circulation and publication for comment is appropriate yields constructive comments that can be considered before any analysis is finalized. Therefore, we do not plan to take comments on pest risk analyses while they are under development.
With regard to notifying commenters at the time import requests are received, we will begin making available, on a quarterly basis, a document that lists all outstanding pest risk analysis import requests made by countries that have provided the information required under the regulations in § 319.5 for us to begin the risk analysis process. The list will be available on the Internet and will include contact information if stakeholders want additional information on the status of specific pest risk analyses.
Finally, we must again emphasize that the changes made in this rule will not reduce or impair in any way the opportunities that stakeholders will have to offer input or comments. As has been the case prior to this final rule, the public will be afforded ample opportunity to offer comments on any proposed import action. The only difference under this final rule will be that in some cases, comments will be solicited through the notice-based process.
One commenter stated that commenters often raise valid regulatory or science-based concerns during the comment period that tend to be discounted by APHIS and that commodities are permitted entry regardless of biological threats.
We disagree strongly with the view expressed by the commenter. First, we must point out that the comment does not address the substance of the rule, but the commenter's apparent disagreement with prior agency decisions. Second, it must be noted again that when we receive comments on a proposed rule or its supporting analyses, we consider carefully the individual issues raised in those comments and respond as comprehensively as we can to each of them in our final rule. In some cases, we agree with the points raised by the commenters and change our approach accordingly in the final rule; indeed, in some cases we will withdraw a particular proposal in light of new information offered by commenters. Conversely, when we do not agree with a point raised by a commenter, we provide an explanation in our final rule as to why we disagree and why we are continuing with a particular approach. We will continue to consider carefully all comments under the notice-based approach and to address those comments in the context of the final pest risk analyses that will be made available prior to the approval of new imports. We have stated in the past that if zero tolerance for pest risk were the standard applied to international trade in agricultural commodities, it is quite likely that no country would ever be able to export a fresh agricultural commodity to any other country. Our pest risk analysis process will identify and assign appropriate effective mitigations for any identified pest risks, i.e., the biological threats referred to by the commenter. If, based on our pest risk analysis, we conclude that the available mitigation measures against identified pest risks are insufficient to provide an appropriate level of protection, then we will not authorize the importation of the particular commodity.
Benefits of Implementing Notice-Based Approach
Several commenters stated that we cited benefits to consumers, but none to domestic producers. Three commenters stated that the benefits to consumers seem overstated and the risks to domestic agriculture from increased and expanded imports are downplayed. One of those commenters added that she was worried that we were opening the floodgates to cheap imports that would put domestic producers at a disadvantage.
The risks associated with new imports are not downplayed and will continue to be considered and addressed with scientific rigor. Benefits to domestic consumers were a factor in developing the notice-based approach, but certainly not the only one. APHIS can attest to the fact that many trading partners do at times consider the length of the process to be burdensome and indefensible. We emphasized in the proposed rule that to the extent that our trading partners consider the length of time it takes to conduct the import approval process through rulemaking a trade barrier, the changes to that process in this rule could facilitate the export of U.S. agricultural commodities by demonstrating our commitment to eliminating trade barriers and encouraging our trading partners to do the same. Such an outcome would be of benefit to domestic producers. While we recognize that new imports may occasionally have some negative economic impacts on some domestic producers due to increased competition, our decisionmaking is tied under our plant health authorities to the assessment of risk, not issues of economic competitiveness.
Several commenters stated that there are often barriers to domestic producers that are not always based on science and asked what assurances domestic producers had that facilitating our import approval process will prompt a similar response from foreign countries. Two commenters asked if each of the countries which have been granted access to the U.S. market have an equivalent and reciprocal process. Three commenters added that we should obtain assurances from our trading partners that they will simplify their import processes as well.
USDA actively and vigorously pursues foreign market access for U.S. products. While we anticipate that this rulemaking will support these efforts, there are no guarantees. We are obligated to follow the principles and procedures of World Trade Organization (WTO) agreements, including the obligation to base our regulations on science. Other members of the WTO are obligated to do so as well. We view this rule as a measure for improving the timeliness of our action on import requests, and of our emphasis on science as a basis for decisionmaking while maintaining the fullest practicable opportunity for all interested parties to participate in the process. We expect our trading partners to evaluate our requests with equivalent dispatch. Each country has its own process, with some being more complex than others; our process is one of the most scientifically rigorous, but one which will be improved by this final rule.
One commenter asked that we conduct yearly examinations of changes in market access, response to petitions, etc., and another asked that we identify instances in which foreign trading partners have substantially modified their approach to U.S. fruit and vegetable exports on the basis of how APHIS has reduced the administrative burden on fruit and vegetable exports to the United States.
APHIS has produced reports that document our activities and accomplishments in support of both phytosanitary (plant health) and sanitary (zoonotics and animal health) trade activities on a regular basis for several years. Those reports describe the activities pertaining to U.S. export market access, retention, and expansion, as well as changes in import market access. Reports through fiscal year 2005 can be found at http://www.aphis.usda.gov/is/tst/Publications.html. We will continue to analyze our accomplishments in both import and export activities on a regular basis. These reports provide an opportunity for the public to evaluate our performance in facilitating imports and exports.
Several commenters disagreed that the current rulemaking process was an impediment to trade and stated that we need to allow maximum opportunity for public comment. One commenter stated that whether or not our rulemaking process was an impediment to trade is a matter for WTO, not foreign countries, to determine.
As stated previously, the notice-based approach will not in any way diminish the opportunity for public comment. We have stated and believe that some countries view our process for approval of import requests as a substantial impediment to trade. We proposed this action with the intent of making the Agency more effective and efficient, while still employing an exceptionally transparent, science-based risk analysis process with the widest possible opportunity for public input. We believe that by modifying the administrative part of our import evaluation process, we will be better able to focus our resources. Given the considerable improvements in risk management documentation and the increase in the number of personnel dedicated to risk management in PPQ in recent years, we are convinced that the notice-based process will expedite the import evaluation process and make it more open and transparent than it has ever been.
Two commenters asked whether we had sufficient staff to handle expedited scientific reviews. The commenters asked that APHIS provide the number of scientists currently dedicated to fruit and vegetable pest and disease risk analyses. One of the commenters asked that this information be provided to the public each time a new import request is made. The commenter asked that we clarify the current backlog on risk analyses.
The commenters clearly misunderstand the purpose, intent, and import of this rule. As stated previously, the notice-based process is not an expedited scientific review. The science-based risk analysis process will remain the same—it is the administrative process that will be expedited. With regard to personnel, we have sufficient personnel available to handle the review of data and information for the completion of pest risk analyses. We are unable to provide the exact number of scientists dedicated to fruit and vegetable pest risk analyses because all are not dedicated to import-related issues. Some of those scientists are also completing assessments for issues related to the facilitation of exports  and crucial domestic programs. In addition, at any given time, the numbers can vary based on whether the scientists are assigned to one area or another in response to workload and changing priorities.
With regard to notifying the public of new import requests, we noted earlier in this document that we will be providing, on a quarterly basis, a document that lists all outstanding pest risk analysis import requests, by commodity and country, made by countries that have provided the information required under the regulations in § 319.5 for us to begin the risk analysis process. That document will be posted on the Internet and distributed to persons who have signed up to the PPQ stakeholder registry. To join the registry, go to PPQ's Internet home page (http://www.aphis.usda.gov/plant_health/) and follow the “Join the PPQ Stakeholder Registry” link.
With respect to the backlog of risk analyses, we noted in the proposed rule that we have approximately 400 “requests” in the queue. However, we received many of these requests some time ago but have been unable to take action on them because they were incomplete or otherwise lacking and a response to our inquiries has not yet been received from the requestor. If, for the purposes of estimating the backlog, we were to count only those official requests that are supported by required information at this time, we have approximately 70 that are pending assignment and prioritization and 110 in various stages of development.
Three commenters raised concerns with issues brought up in the National Plant Board (NPB) report titled, “Safeguarding American Plant Resources (A Stakeholder Review of the APHIS-PPQ Safeguarding System).” The report, published in July of 1999, examined APHIS' safeguarding system and made recommendations to improve upon the system. The commenters stated that there should be no changes to the regulations until the report is finalized and its recommendations are taken into full account. One of those commenters stated that the report contains references to fragmented and dispersed risk management functions; the need for a better process to monitor the efficacy of risk mitigation measures; and more training and actual field experience to ensure that mitigation measures chosen are operationally feasible. The commenter added that the risk analysis program is not yet adequately funded.
In August 2005, we reported that PPQ had completed the implementation process for the recommendations contained in the stakeholder review, with virtually all of the more than 300 recommendations in the Safeguarding Review fully evaluated and implemented or in the process of being implemented.  Among our accomplishments during the first 5 years of the implementation phase were the strengthening and restructuring of our risk assessment work and the building of a strong methods development program through our Center for Plant Health Science and Technology (CPHST). We have clarified roles and responsibilities for risk management in PPQ and dedicated additional resources to that function.
In terms of monitoring the efficacy of risk mitigation measures, we work closely with the Bureau of Customs and Border Protection (CBP) on measures such as fruit cutting at the port of entry and port of entry inspections. Inspection guidelines based on our pest risk analyses are developed for each new commodity allowed entry into the United States. In addition, APHIS' International Services staff also monitors programs in exporting countries to ensure that mitigation measures are being appropriately applied and that they are effective.
With regard to the need for more training and actual field experience to assure that the mitigation measures chosen are operationally feasible, we routinely provide opportunities for our risk managers, some of whom have extensive operational experience, to observe and participate in the application of field measures.
Finally, we disagree that the risk analysis program is not yet adequately funded. As noted previously, we believe that we have sufficient personnel available to handle the review of data and information for the completion of pest risk analyses and have recently hired several additional risk analysts.
Four commenters raised concerns with CBP having sufficient resources and staff to monitor the increased imports that would be associated with this rule. Three of those commenters referenced a recent Government Accountability Office (GAO) report in which GAO determined that despite some positive developments, “the agencies face management and coordination problems that increase the vulnerability of U.S. agriculture to foreign pests. CBP has not developed sufficient performance measures that take into account the agency's expanded mission or that consider all pathways by which prohibited agricultural items or foreign pests may enter the country.” The commenters stated CBP faces significant resource and performance issues and that this could lead to future pest infestations. One commenter stated that there would be an increased need for additional APHIS staff to monitor the imports and the conditions imposed on future imports. The commenter noted that if we were to presume that most of those requests are eligible for the notice-based process and the commodities start to enter the United States, it appears that APHIS does not have the staff to monitor its mitigation measures.
We consult with CBP at various stages of the rulemaking process, beginning once a regulatory work plan has been developed and through the publication of a final rule. We will similarly consult with CBP about actions that we may take based on the notice-based process established by this rule. CBP may raise any concerns with monitoring required for mitigation measures at those times. If CBP does not have the appropriate resources to monitor mitigations as determined by the pest risk analysis, then we will modify our mitigations or otherwise work with CBP to find efficacious mitigation measures that CBP can monitor.
Further, increased imports will also generate more revenue for APHIS and CBP through the collection of additional user fees. This increase in funds can be used to increase staffing and improve upon other resources that will be used to monitor mitigations. With regard to CBP not having developed sufficient performance measures, new performance measures were developed by CBP and were implemented on October 1, 2006.
One commenter asked if more resources would be devoted toward export petitions as a result of this final rule.
APHIS employs trade directors who are assigned specific geographic areas of responsibility, and each trade director works with one import specialist and one export specialist. There will be no changes to this structure as a result of this final rule. As noted previously, when pest risk analyses are needed for export issues, they are always assigned a high priority.
Import Requirements for Specific Commodities
One commenter wanted to clarify that pineapple from Thailand will be subject to general requirements under § 319.56-3 and proposed paragraphs (b)(2)(vi) and (b)(5)(vii) of § 319.56-13, but no other requirements. The commenter also asked why pineapple from Thailand has been restricted importation to Hawaii.
Section 319.56-13 of our proposed rule erroneously stated that pineapple from Thailand was prohibited entry into Hawaii only, when in fact it is currently prohibited entry into all U.S. States and territories except for Guam and the Commonwealth of the Northern Mariana Islands (CNMI). To correct this error, we are revising the entry in the table for pineapples from Thailand in § 319.56-13 to provide that pineapple from Thailand is allowed entry into Guam and CNMI only.
Two commenters requested that we remove the preclearance inspection requirement for sand pears from Korea because it had not been required previously.
The commenters are incorrect. As stated previously, the proposed rule did not make any changes to existing import requirements, except for those specifically mentioned in the rule. We have been requiring preclearance inspections for sand pears from Korea since 1990, and while that requirement was not listed in the regulations it has been contained in the fruits and vegetables manual and is implemented by administrative order.
We proposed to clarify that only Allium spp. without tops may be imported into Guam, due to the presence of the leaf tip die back disease, Mycosphaerella schoenoprasi, and exotic species of leaf miners of Allium spp. in countries that regularly trade with Guam. One commenter asked that we continue to allow Allium spp. from South Korea into Guam under the same conditions that we have in the past. The commenter added that tops of Welsh onion (Allium fistulosum) and stems of garlic (Allium sativum) have historically been allowed importation into Guam from South Korea and that the sudden prohibition of those vegetable parts as a result of the proposed changes would have an effect on Korean residents living in Guam.
We proposed to allow only Allium spp. without tops to be imported into Guam, due to the presence of the leaf tip die back disease, Mycosphaerella schoenoprasi, and exotic species of leaf miners of Allium spp. in countries that regularly trade with Guam. Those pests, which are associated with the Allium spp. tops and are not pests of Allium spp. bulbs, are not present in Guam. The restrictions on the importation of Allium spp. tops are necessary to prevent the introduction of Mycosphaerella schoenoprasi and exotic species of leaf miners into Guam.
One commenter asked that the regulations, where they provide for the importation of pineapples, be amended to cover all varieties of pineapple, not just varieties that are limited to at least 50 percent smooth Cayenne by lineage.
We cannot make such a change in this final rule. We would need to consider and document the risks associated with such a change and publish a proposed rule before we could amend the regulations to expand the number of pineapple varieties eligible for importation.
Two commenters asked that we remove the phytosanitary certificate requirement for peppers from the Netherlands because a method to ensure full traceability is still under discussion.
Following an interception of Mediterranean fruit fly (Medfly) in a consignment of habanero peppers shipped via the Netherlands, we began requiring consignments of peppers from the Netherlands to be accompanied by a phytosanitary certificate stating that the fruit had originated in a greenhouse in the Netherlands. When we began drafting our proposal, we believed it was necessary to reflect that administrative phytosanitary certificate requirement, which was cited in the fruits and vegetables manual, in the regulations. However, since the publication of the proposed rule, we have engaged in additional discussions with officials of the Dutch NPPO and have agreed that they have adequately addressed the Medfly issue that prompted the phytosanitary certificate requirement. That requirement had been the only specified condition that necessitated peppers from the Netherlands being listed in the table in § 319.56-13, so that entry does not appear in this final rule. We have also removed proposed paragraph (b)(5)(xi) in § 319.56-13, which contained the phytosanitary requirement, because it is not applicable to any other entries in the table and have redesignated the remaining subparagraphs in paragraph (b)(5) accordingly.
Pest Risk Analyses Back to Top
One commenter asked how we will handle issues raised in the comment period that call into question the use of the notice-based approach on an import request.
As established by this rule, the notice-based process is appropriate when we conclude, based on pest risk analysis, that the risks associated with a particular candidate for importation can be addressed using one or more of the designated measures listed in § 319.56-4(b). Accordingly, if information submitted during the comment period led us to change our conclusion about the appropriateness of those measures, then the notice-based process would end without the issuance of a permit. If the submitted information did not lead us to change our conclusions, we would likely proceed with a subsequent Federal Register notice announcing that we will begin issuing import permits; in that notice, we would discuss all the comments we received and our reasons for proceeding as we did.
One commenter asked under what specific circumstances would APHIS publish a notice in the Federal Register, revising import requirements for certain imports, or prohibiting or restricting the importation of certain products as provided for in § 319.56-4(d). The commenter also asked if APHIS would publish a followup notice if it resolves the problem which prompted publication of such an action and notice in the Federal Register.
Paragraph (d) of § 319.56-4 in the proposed rule and in this final rule provides that if we determine that one or more of the designated measures is not sufficient to mitigate the risk posed by any fruit or vegetable that has been authorized for importation under permit in accordance with § 319.56-4, then APHIS will prohibit or further restrict the importation of the fruit or vegetable, and that we may publish a notice to inform the public of our findings. That notice would specify the amended import requirements, provide an effective date for the change, and invite public comment on the subject. As for what specific circumstances might lead us to take the actions described in § 319.56-4(d), our proposed rule offered examples such as interceptions of new pests in imported fruits or vegetables or new evidence of risk or evidence of poor program implementation or performance. With respect to whether we would publish a followup notice following the resolution of a problem, we expect that such a decision would depend on the circumstances leading up to our initial action and the nature of our action (i.e., a prohibition on imports, a temporary suspension, the addition of new requirements, etc.). In any case, our goal will be to keep the public informed and ensure the transparency of our decisionmaking.
One commenter asked why we were requiring exporting countries to conduct pest risk analyses when ISPM standards require that importing countries do so.
We are not requiring that exporting countries conduct their own pest risk analyses, although an exporting country may provide substantial inputs and they may benefit by doing so. The main benefit of an exporting country assisting in conducting the pest risk analysis is that it can improve the quality of the data and conclusions and the validity and credibility of the analysis. In some cases, it might also expedite the approval of the commodity the country wishes to export. However, all externally prepared pest risk analyses are thoroughly evaluated by APHIS for completeness and consistency with APHIS-prepared analyses and revised as necessary.
Section 319.56-2dd has contained restrictions on the importation of tomatoes from certain countries. In our proposal, we discussed moving that section to new § 319.56-28 and stated that one of the changes we were proposing in conjunction with that move was to require the use of insect-proof containers or coverings, rather than fruit fly-proof containers or coverings. One commenter took issue with this proposed change, stating that it was unnecessary to address pest risk and citing significant economic costs that would be associated with covering tomatoes.
Our statement in the proposed rule that “[t]he current regulations require packaging and containers to be fruit fly-proof, not insect-proof” was in error; we should not have presented the subject as a proposed change in the regulations. The regulations in § 319.56-2dd have required insect-proof containers or coverings since June 25, 2003, when we published a final rule (68 FR 37904-37923, Docket No. 02-026-4) making that change among many others. Prior to that, fruit fly-proof coverings and containers had been required, and that requirement had been in place since the regulations in § 319.56-2dd were established in 1998.
One commenter stated that it is unnecessary to require that tomatoes be packed in insect-proof cartons or containers or covered by insect-proof mesh or plastic tarpaulins during transport to the airport and subsequent exportation to the United States because any harmful insects that are present in a greenhouse will leave the tomatoes at the time of harvesting due to the moving of the plants. The commenter added that tomatoes which have been picked and are subsequently transported with the production facility do not attract additional insects.
While the commenter may be correct with regard to specific targeted pests, the insect-proof mesh or plastic tarpaulin is intended to prevent hitchhiking pests that may attach to fruit while in transit, and not only pests that could attach at the time of growing, harvesting, or packing.
Use of Terms
One commenter noted that proposed § 319.56-6 provides that if APHIS is to be present in an exporting country to facilitate the exportation of fruits and vegetables and APHIS services are to be funded by the NPPO of the exporting country or a private export group, then the NPPO or private group must enter into a trust fund agreement with APHIS. The commenter contrasted that provision with proposed §§ 319.56-23(b) and 319.56-38(f), which specifically state that the importation of the authorized commodities from Chile would be possible only if the Servicio Agricola y Ganadero (SAG) has entered into a trust fund agreement. The commenter asked that we clarify that the same would be expected of a private export group.
We agree with the commenter and have amended §§ 319.56-23(b) and 319.56-38(f) in this final rule to be consistent with the wording of § 319.56-6.
One commenter noted that proposed § 319.56-29 refers to the Chinese Ministry of Agriculture, while § 319.56-39 refers to the NPPO of China.
For consistency's sake, both of those sections in this final rule refer to the NPPO of China.
Frozen Fruit and Quick Freezing
One commenter stated that there is some confusion around the concept of frozen fruit and asked that we add a definition of frozen fruit in § 319.56-2.
We use the term frozen fruits and vegetables as a description and quick freezing as the method used to obtain the frozen state. However, to provide clarification, this final rule includes a definition of frozen fruit or vegetable in § 319.56-2, i.e.: “Any variety of raw fruit or vegetable preserved by commercially acceptable freezing methods in such a way that the commodity remains at −6.7 °C (20 °F) or below for at least 48 hours prior to release.”
Proposed § 319-56-12 provided that the importation from foreign countries of frozen fruits and vegetables is not authorized when such fruits and vegetables are subject to attack in the area of origin by plant pests that may not, in the judgment of the Administrator, be destroyed by quick freezing. One commenter asked how the Administrator will communicate the list of plant pests that are not destroyed by quick freezing.
Section 305.17(b) of our phytosanitary treatments regulations contains a list of fruits and vegetables and their countries of origin for which quick freezing is not an authorized treatment. We have amended § 319.56-12 in this final rule to provide that quick freezing is not an authorized treatment for those fruits and vegetables listed in § 305.17(b).
One commenter asked if quick freezing would also be subject to the monitoring and certification requirements under § 305.3.
Yes, quick freezing is considered a treatment and therefore, will be subject to the requirements in § 305.3, “Monitoring and certification of treatments.”
One commenter stated that we did not specify whether the notice published with APHIS' final determination will contain responses to public comments. The commenter noted that the opportunity for comment is meaningless unless the Agency responds to the significant points raised by the public.
We intend to carefully review all comments we receive on the risk analyses. We are soliciting comments to help us determine the appropriate course of action and may change course based on comments. While the flow chart we presented on page 25017 of the proposed rule makes reference to a discussion of the comments being included with the pest risk analysis in the second notice, our discussion of the process may not clearly communicate our intention to respond to the comments we receive. We did not intend to imply that the notice-based process would eliminate our responding to the comments we receive on the notices. We will continue to respond to all substantive comments and will make the comments and our responses available as attachments to draft or final pest risk analyses.
One commenter noted that proposed § 319.56-4(d) states that APHIS “may” prohibit or further restrict the importation of the fruit or vegetable that has been approved for importation under § 319.56-4 when we determine that additional risk mitigation measures are necessary. The commenter stated that the use of the word “may” made it unclear whether or not we would in fact act to prohibit or further restrict a commodity should it become necessary. The commenter suggested rewording the sentence to read that “APHIS shall prohibit or further restrict importation * * *.”
We agree that our use of the word “may” could leave some doubt as to whether we will prohibit or further restrict imports if we determine that one of the designated phytosanitary measures is not sufficient to mitigate the risk posed by authorized imports. Therefore, we have amended § 319.56-4(d) in this final rule so that it reads “APHIS will prohibit or further restrict importation of the fruit or vegetable. APHIS also may publish a notice in the Federal Register advising the public of its finding.”
One commenter stated that we should consider limiting consignments of fruits and vegetables into States like Florida that have crops that are highly susceptible to infestation by pests and diseases from countries which do not have equivalent plant pest agencies.
We consider limiting distribution of imports on a case-by-case basis when the findings of pest risk analysis indicate that such an action might be necessary and if it is operationally feasible. Limited distribution is not, however, one of the designated measures listed in this rule.
Our consideration of this comment brought to mind an issue that we believe bears clarifying. The pest risk analyses we use to inform our decisionmaking with respect to specific commodities are usually prepared by PPQ's Center for Plant Health Science and Technology (CPHST). In an effort to be as responsive as possible, CPHST routinely limits the scope of its analyses to the continental United States because doing so reduces the complexity of the analysis and thus saves time. (CPHST will, of course, broaden the scope of the analysis to include Hawaii and/or U.S. territories if the requesting country asks that they do so.) When scope of a pest risk analysis is limited to the continental United States, the scope of the import authorization we may issue for the commodity that was the subject of the analysis is likewise limited to the continental United States. Such a limitation on distribution is applied not as a mitigation in response to an identified pest risk, but rather because we have not examined the risks associated with the movement of that commodity into Hawaii and/or any U.S. territories or possessions. We view this as entirely distinct from those situations where the findings of a pest risk assessment lead our risk managers to recommend limited distribution as a risk mitigation measure, such as is the case, for example, with litchi from certain countries being prohibited from movement into Florida due to the litchi rust mite. We believe that the first situation—where distribution is authorized only within the continental United States due simply to the scope of pest risk analysis—does not preclude the use of the notice-based approach if the use of that approach is otherwise appropriate. In the latter situation, the notice-based approach would not be appropriate, given that limited distribution assigned as a mitigation measure in response to an identified risk is not among the designated measures.
One commenter stated that increasing amounts of imports have increased pest infestations and that APHIS' pest risk analyses and mitigation procedures do not always work, especially in the case of imports from developing countries.
The commenter provided no evidence to support the assertion that increasing imports have led to an increase in pest infestations. As stated previously in this document, there will always be some degree of pest risk associated with the movement of agricultural products; APHIS' goal is to provide the protection necessary to prevent the introduction and dissemination of plant pests into the United States while facilitating trade in agricultural products. Further, there are several factors that contribute to pest infestations, including smuggling, undeclared fruits and vegetables in passenger baggage, and, as with soybean rust, climatic conditions. We also note that legal imports undergo a rigorous scientific evaluation before being approved for importation and are subject to mitigation measures to which illegal imports are not.
Three commenters stated that it was unfair to expedite the importation of foreign fruits and vegetables when changes in interstate consignments of produce governed by Federal quarantine continue to be subject to rulemaking. One of those commenters specifically requested that we also allow imports from Hawaii and the territories to be eligible for a similar notice-based process in the final rule.
While we are not making any changes in this final rule in response to this comment, we are currently considering revising part 318 to provide the same notice-based process for Hawaii and the territories. Further, we are reviewing our domestic quarantine regulations in part 301 to determine whether opportunities exist to expedite movements of regulated products.
One commenter asked for clarification of the respective responsibilities of APHIS and CBP. Another commenter encouraged APHIS to provide increased compliance assistance to U.S. import companies and to exporting countries where new commodities are approved for entry.
CBP personnel at ports of entry have many responsibilities, among them examining agricultural imports for the protection of America's agriculture, environment, and food supply from pests, diseases, and agroterrorism. CBP conducts inspections and facilitates the clearance of most agricultural products. APHIS-staffed plant inspection stations are responsible for the inspection and clearance of the majority of propagative material consignments as well as certain material arriving under permit. CBP and APHIS work together as a team to safeguard U.S. agriculture, setting policy, training officers, and improving the import processes.
APHIS is currently studying and working with CBP on standard operating procedures that can be used by carriers to ensure that agricultural commodities are handled and transported in accordance with APHIS regulations. These new standards will allow carriers to more easily handle consignments in accordance with U.S. requirements. Importers, shippers, and ultimately the public will benefit from this new uniform policy.
We meet regularly with our counterparts in exporting countries to develop bilateral work plans detailing specific procedures when new commodities are approved for entry and we will continue to do so. In addition, we provide an individual contact person for each notice who can be reached should specific questions arise.
One commenter stated that fruits and vegetables should be subject to strict inspections. The commenter also suggested that we should conduct a trial run of the notice-based process in a few countries to see how effective this approach is.
All imported fruits and vegetables are currently and will continue to be subject to inspection at the port of entry. With regard to the suggested trial, the rule does not make any changes to operations or the pest risk analysis process, it is simply providing for an expedited administrative process. Accordingly, we do not believe that implementing this rule on a trial basis would be appropriate or useful. At the same time, we regularly review our processes to ensure their continued effectiveness and make changes whenever necessary.
One commenter asked what type of peer review process will be utilized under the notice-based approach.
If the information that will be disseminated in a pest risk analysis is determined to be “influential” or “highly influential” as those terms are used in the Office of Management and Budget's “Final Information Quality Bulletin for Peer Review,” (see 70 FR 2664-2667, published January 14, 2005), then a peer review will be conducted in accordance with USDA's peer review guidance (see http://www.ocio.usda.gov/qi_guide/scientific_research.html).
One commenter questioned the basis for APHIS decisionmaking regarding approval of import requests.
Under the Plant Protection Act, the Secretary may prohibit or restrict the importation of plants and plant products if the Secretary determines that the prohibition or restriction is necessary to prevent the introduction into or dissemination within the United States of a plant pest or noxious weed. Thus, our determinations as to whether a new agricultural commodity can be safely imported are based on the findings of pest risk analysis.
One commenter stated that the proposed changes did nothing to address the fact that APHIS' regulations continue to prohibit the importation of fruits and vegetables for which no import request has been made, or for which an import request has been made but an assessment of quarantine risk has not yet been completed. The commenter stated that this “a priori” prohibition on the importation of fresh fruits or vegetables into the United States is inconsistent with the APHIS' obligations under the WTO's Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), as they are not based on an assessment of risks or scientific principles, nor maintained with sufficient scientific evidence.
We believe it is appropriate to make a distinction between commodities that are “prohibited” and disciplined by Article 5 of the SPS Agreement, and commodities that are “not yet approved” or “pending evaluation” and disciplined by Annex C of the SPS Agreement. Articles that are prohibited have been evaluated and prohibition is the measure that has been determined to be appropriate. This status may be changed based on new information and a reevaluation using pest risk analysis. Likewise, pest risk analysis is used to evaluate the risk associated with a request for a new commodity not previously evaluated. It is true that our regulations do not make the distinction between (1) commodities that have been evaluated and prohibited, (2) commodities that are not currently allowed importation but that are undergoing risk evaluation, and (3) commodities that are not allowed importation and for which no request for risk evaluation exists. We recognize that our regulatory terminology is not the same as that used in the SPS Agreement; however, regardless of the terminology, APHIS only allows new imports of fruits and vegetables following the completion of a risk analysis that enables us to determine that the pest risks posed by the commodity are known, and that the risks can and will be mitigated. We believe that this policy is entirely consistent with the SPS Agreement.
One commenter stated that phytosanitary certificates should be required for all consignments of imported fruits and vegetables.
On August 29, 2001, we published in the Federal Register (66 FR 45637-45648) a proposal to require phytosanitary certificates for all imported fruits and vegetables. During the comment period, some commenters raised issues that put into question whether this approach was warranted. In response to those commenters, we prepared a risk assessment that considered the plant pest risks associated with fruits and vegetables imported in passenger baggage and the probable impact of phytosanitary certification requirements. On May 24, 2006, we published in the Federal Register (71 FR 29846-29847) a notice of availability of that risk assessment. We are considering adopting only the proposed requirements that pertain to fruits and vegetables imported in air passenger baggage and are currently assessing the comments we received.
One commenter cautioned against the labeling requirements contained in proposed § 319.56-5. Specifically, the commenter took issue with our requiring the orchard or grove of origin/name of grower and the name of the municipality and State where the fruits or vegetables were produced. The commenter was concerned that our trading partners would require the same of U.S. grain and grain products.
We made no changes to the labeling requirements that are now contained in § 319.56-5. The labeling requirements in § 319.56-5 apply to fruits and vegetables grown in pest-free areas. Therefore, we must require that information about the origin of the product be included on the label in order to verify that the fruit is indeed from a pest-free area. This information also allows us to work effectively with the NPPO of the exporting country to conduct tracebacks if quarantine pests are found in a consignment.
One commenter stated that the 60-day comment period was too long. The commenter asked that the comment period be reduced so that import approvals can be issued no later than 6 months after the completion of the pest risk analysis.
When developing our proposed rule, we wanted to ensure that we did not reduce the opportunity for public comment. We believe maintaining a 60-day comment period is reasonable and appropriate. Further, even with a 60-day comment period, import approvals could be issued within 6 months of announcing the availability of a pest risk analysis.
One commenter asked if we will still produce, as we have in the past, proposed rules covering a wide variety of articles (often referred to as “periodic amendments”) and if so, how those periodic amendments will relate to the notice-based approach.
Implementation of the notice-based process will likely reduce the need to group import requests together in periodic amendments, but we expect we will continue to use periodic amendments (as opposed to standalone rulemakings) to add some commodities to the regulations that require mitigations beyond the designated measures.
One commenter asked how the notice-based process will affect pending import requests from Guatemala. The commenter asked if previously submitted import requests needed to be resubmitted for the commodity to qualify for the notice-based approach.
This rule will be applied to pending requests. If an import request has already been submitted and the results of our pest risk analysis lead us to conclude that the commodity can be safely imported under one or more designated measures, then we will follow the notice-based approach. It is not necessary to resubmit any import requests.
One commenter asked if the United States or the exporting country makes decisions on which products are to be exported.
While there may be instances where the impetus for a specific import request comes from an importer or other entity in the United States, it is the NPPO of the exporting country that submits the formal petition to APHIS.
One commenter asked if the exporting country needs to inspect the commodity as well.
Under some circumstances, we find that inspection prior to exportation is a necessary part of mitigating pest risk and the exporting country would need to inspect the commodity. Such an inspection requirement would be one of the mitigations included in the pest risk analysis.
One commenter disagreed with not conducting an economic analysis on future imports that are approved under the notice-based process. The commenter stated that the economic impacts on domestic producers should be part of any trade agreement the United States negotiates. The commenter added that foreign producers are not subject to the same environmental and phytosanitary restrictions under which U.S. domestic producers operate, which puts our domestic producers at a distinct competitive disadvantage.
As stated previously in this document, our determination as to whether a new agricultural commodity can be safely imported is based on the findings of pest risk analysis, not on economic factors. While the notices published using the notice-based approach will not contain economic analyses, we will certainly consider the potential economic consequences of pest introduction in the pest risk analysis.
One commenter stated that the measures listed for use at the port of Wilmington, NC, should incorporate measures to monitor any Medfly that may escape treatment and should include measures to ensure the cold treatment facility has a contingency plan for disposing of the fruit. The commenter stated that the measures employed at the Port of Wilmington should be at least as stringent as those for Seattle, WA, and Atlanta, GA.
We did not propose to make any changes to the cold treatment requirements performed at ports of entry in the United States, we simply proposed to move these requirements into a different section. Further, the measures to which the commenter refers are determined by risk and Wilmington, NC, is not considered a high pest risk port because it is unlikely that exotic fruit flies will become established in the Wilmington area.
Two commenters raised issues regarding the irradiation of fruits and vegetables. Specifically, one of the commenters questioned the use of irradiation because there is evidence that there is nutrient depletion when foods are subjected to it. The commenter also stated that certain fruits and vegetables may produce cyclobutanones when irradiated which in some studies have shown to act as tumor promoters. The second commenter stated that irradiation is not safe and allowing fruits and vegetables that have not been pretreated to enter the United States opens the doors to pest infestation.
The Food and Drug Administration (FDA) has primary regulatory responsibility for ensuring that approved irradiation doses do not render foods unsafe to eat. FDA regulations (21 CFR 179.26) establish a limit of 1.0 kilogray for disinfestation of arthropod pests in fresh fruits and vegetables. With respect to the second commenter's additional concern, we established the irradiation-related provisions in part 305 through earlier rulemakings and did not propose any changes to those provisions in our proposed rule.
In addition to the changes discussed above in response to comments, we have made the following changes in this final rule:
- We have amended § 305.15(b) by removing Washington Dulles International Airport as a port where cold treatment may be conducted. There is not currently an approved cold treatment facility at that airport.
- Paragraph (a) of § 305.31 includes a list of several plant pests for which irradiation is an authorized treatment, but paragraph (n) of that section has referred to “the listed fruit flies.” Because the list also includes borers, weevils, moths, etc., we have amended § 305.31(n) by replacing the reference to fruit flies with a more general reference to plants pests.
- We have removed proposed paragraph (b)(7) of § 319.56-3, which would have provided for the issuance of special use permits to authorize the importation of small lots of otherwise prohibited fruits or vegetable under certain conditions. After reconsidering the issue, we no longer believe that we have adequate resources to devote to these types of permits.
- We have removed proposed paragraphs (b)(5)(i) and (b)(5)(xii) from § 319.56-13 and have renumbered the remaining paragraphs in § 319.56- 13(b)(5) accordingly. The first of those paragraphs referred to a phytosanitary certificate requirement that does not apply to any of the commodities listed in the table in paragraph (a) of that section. The second of those paragraphs referred to a phytosanitary certificate/additional declaration requirement regarding freedom from the gray pineapple mealybug (Dysmicoccus neobrevipes). That paragraph was cited only in the entry for honeydew melon from Peru in the table, and that honeydew melon entry also cites paragraph (b)(1)(iv), which includes, among other things, the same phytosanitary certificate requirement. Therefore, proposed (b)(5)(xii) was redundant and has been removed.
Changes to the Regulations Since the Publication of Our Proposal
Since the publication of the proposed rule, several final rules that amended the regulations in part 319 have become effective, and the changes made to the regulations in those final rules need to be reflected in this rule.
On May 1, 2006 (see 71 FR 25487-25495, Docket No. 03-113-3), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2pp, “Conditions governing the importation of citrus from Peru,” to allow the importation, under certain conditions, of fresh commercial citrus fruit (grapefruit, limes, mandarin oranges or tangerines, sweet oranges, and tangelos) from approved areas of Peru into the United States. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as § 319-56-41.
On May 22, 2006 (see 71 FR 29241-29244, Docket No. 05-068-2), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2qq, “Administrative instructions: Conditions governing the entry of peppers from the Republic of Korea,” to allow the importation into the continental United States of peppers from the Republic of Korea under certain conditions. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as § 319-56-42.
On May 24, 2006 (see 71 FR 29766-29769, Docket No. 05-059-2), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2f, “Conditions governing the entry of baby corn and baby carrots from Zambia,” to allow the importation into the continental United States of fresh, dehusked, immature (baby) sweet corn and fresh baby carrots from Zambia. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as § 319-56-43.
On June 8, 2006 (see 71 FR 33172-33178, Docket No. 03-048-3), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2rr, “Administrative instructions: Conditions governing the importation of untreated grapefruit, sweet oranges, and tangerines from Mexico for processing,” to provide for the importation of untreated citrus (grapefruit, sweet oranges, and tangerines) from Mexico for processing under certain conditions. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as § 319-56-44.
On August 23, 2006 (see 71 FR 49319-49326, Docket No. 00-086-2), we published a final rule that amended the plant quarantine safeguard regulations in 7 CFR part 352. Among other things, that final rule amended paragraph (e) of § 352.30 by removing a reference to the State of Sonora in order to make it clear that oranges, tangerines, and grapefruit that are moving in transit to foreign countries may be imported into the United States from any municipality in Mexico that has been recognized as a fruit fly-free area. To reflect that change, we have removed the reference to Sonora in this final rule's revision of § 352.30(e).
On August 25, 2006 (see 71 FR 50320-50328, Docket No. APHIS-2006-0096), we published an interim rule that, among other things, amended the general permit in § 319.56-2(c) for fruits and vegetables grown in Canada to state that Canadian-grown fruits and vegetables are subject to the inspection and other requirements of § 319.56-6 (§ 319.56-3(d) in this final rule). In this final rule, we have amended the text of the general permit for fruits and vegetables grown in Canada, which now appears in § 319.56-10(a), to reflect that change.
On August 28, 2006 (see 71 FR 50837-50843, Docket No. APHIS-2006-0009), we published a final rule that amended the regulations in § 319.56-2dd, “Administrative instructions: Conditions governing the entry of tomatoes,” by adding a new paragraph (f) to allow pink and red tomatoes grown in approved registered production sites in Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panama to be imported into the United States. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as paragraph (f) of § 319.56-28.
On September 21, 2006 (see 71 FR 55087-55090, Docket No. APHIS 2006-0025), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2ss, “Conditions governing the entry of grapes from Namibia,” to allow for the importation into the United States of fresh table grapes from Namibia under certain conditions. The final rule required that the grapes be cold treated for specific pests, fumigated for specific pests, accompanied by a phytosanitary certificate, and imported in commercial consignments only, all of which are measures that are eligible for the notice-based approach. Therefore, the provisions regarding the entry of table grapes from Namibia do not appear in this final rule; rather, those conditions will be listed in the fruits and vegetables manual.
Section 319.56-30, “Hass avocados from Michoacan, Mexico,” has been updated to reflect the changes made in a technical amendment published on October 18, 2006 (see 71 FR 61373-61374, Docket No. 03-022-7).
On October 24, 2006 (see 71 FR 62197-62198, Docket No. APHIS-2006-0073), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2bb, “Conditions governing the entry of shelled garden peas from Kenya,” to allow for the importation into the United States of shelled garden peas from Kenya into the continental United States under certain conditions. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as § 319.56-45.
On December 18, 2006 (see 71 FR 75649-75659, Docket No. 03-086-3), we published a final rule that made a number of amendments to the fruits and vegetables regulations that need to be reflected in this final rule. Specifically:
- We added a requirement that consignments of Allium spp. consisting of the whole plant or above ground parts be accompanied by a phytosanitary certificate issued by the NPPO of Canada with an additional declaration stating that the articles are free from Acrolepipsis assectella (Zeller). That phytosanitary certificate requirement for Allium spp. from Canada appears in § 319.56-10 of this final rule as paragraph (a)(1).
- We amended the table that has appeared in § 319.56-2t by adding several fruits and vegetables and by revising existing entries for several fruits and vegetables. Many of those changes were reflected in our April 2006 proposed rule, and many of the commodities we added require only mitigations that are eligible for the notice-based approach, so it is not necessary to list them in this final rule. There was, however, one commodity added to the table—citrus (Citrus spp.) fruit from New Zealand—that must meet requirements that go beyond the designated measures, so we have added an entry for New Zealand citrus to the table in § 319.56-13 of this final rule. We also amended the entry for pineapple (Ananas spp.) fruit from South Africa to indicate that the fruit may only be imported into the continental United States. That change is also reflected in this final rule.
- We amended the conditions for importing tomatoes from Chile in § 319.56-2dd(d) by adding provisions to allow the importation of tomatoes from Chile without treatment for Medfly and other pests if the tomatoes are grown and packed in accordance with specified requirements and accompanied by a phytosanitary certificate. Because those import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as paragraph (d)(2) in § 319.56-28.
- We amended the conditions for importing mangoes from the Philippines in § 319.56-2ii by adding provisions to allow mangos to be imported from all areas of the Philippines, except the island of Palawan, into Guam and Hawaii under certain conditions. In this final rule, the provisions for importing mangoes from the Philippines, as amended by Docket No. 03-086-3, appear in § 319.56-33.
On March 12, 2007 (see 72 FR 10902-10907, Docket No. APHIS-2006-0121), we published a final rule that amended the regulations by adding a new § 319.56-2tt, “Conditions governing the entry of mangoes from India,” to allow the importation into the continental United States of mangoes from India under certain conditions. Because the import requirements include additional measures beyond the designated measures, they need to remain in the regulations; those provisions appear in this final rule as § 319.56-46.
On June 21, 2007 (see 72 FR 34163-34176, Docket No. APHIS-2006-0040), we published a final rule that amended the fruits and vegetables regulations by adding a new § 319.56-2uu, “Administrative instructions: Conditions governing the entry of certain fruits from Thailand” to allow the importation into the United States of litchi, longan, mango, mangosteen, pineapple, and rambutan from Thailand under certain conditions. Mango, mangosteen, pineapple and rambutan require only mitigations that are eligible for the notice-based approach, so it is not necessary to list them in this final rule. Litchi and longan, however, have labeling requirements, which go beyond the designated measures, so we have added entries for litchi and longan from Thailand to the table in § 319.56-13 of this final rule.
Therefore, for the reasons given in the proposed rule and in this document, we are adopting the proposed rule as a final rule, with the changes discussed in this document.
Executive Order 12866 and Regulatory Flexibility Act Back to Top
This rule has been reviewed under Executive Order 12866. The rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.
We have prepared an economic analysis for this final rule. It provides a cost-benefit analysis as required by Executive Order 12866, as well as a final regulatory flexibility analysis that considers the potential economic effects of this final rule on small entities, as required by the Regulatory Flexibility Act. The economic analysis is summarized below. Copies of the full analysis are available from the person listed under FOR FURTHER INFORMATION CONTACT. Please refer to Docket No. APHIS-2005-0106 when requesting copies. The full analysis is also available on the Regulations.gov Web site (see footnote 1 at the beginning of this final rule for instructions for accessing Regulations.gov).
In accordance with the Plant Protection Act (7 U.S.C. 7701 et seq.), the Secretary of Agriculture has the authority to promulgate regulations and take measures to prevent the spread of plant pests into or through the United States, which includes regulating the importation of fruits and vegetables into the United States. The Secretary has delegated the responsibility for enforcing the Plant Protection Act to the Administrator of APHIS.
This rule revises and reorganizes the regulations pertaining to the importation of fruits and vegetables to consolidate requirements of general applicability and eliminate redundant requirements, update terms and remove outdated requirements and references, update the regulations that apply to importations of fruits and vegetables into U.S. territories, and make various editorial and nonsubstantive changes to regulations to make them easier to use. APHIS is also making substantive changes to the regulations, including: (1) Establishing criteria within the regulations that, if met, would allow APHIS to approve certain new fruits and vegetables for importation into the United States and to acknowledge pest-free areas in foreign countries without undertaking rulemaking; and (2) doing away with the process of listing specific commodities that may be imported subject to certain types of risk management measures. These changes are necessary to make the APHIS process for approving new imports and pest-free areas more effective and efficient while continuing to provide for public participation in the process.
Summary of Cost-Benefit Analysis Back to Top
International trade in fruits and vegetables—in particular, many new and newly traded commodities—expanded rapidly over the past two decades. This increased trade also reflects a marked change in the variety of products sought by American consumers. According to Food and Agriculture Organization (FAO) data, the average value share of fruits and vegetables (including pulses and tree nuts) in global agricultural exports increased from 11.7 percent in the period 1977-81 to 15.1 percent in 1987-91 and reached an all-time high of 16.5 percent in 1997-2001.  Imports have become increasingly important for domestic fresh fruit and vegetable consumption. In 2004, the United States imported more than $7 billion in fresh fruits and vegetables. Maintaining the current process will make it difficult to keep pace with this rapidly increasing volume of import requests.
The process for approving imports adopted in this rule will apply only to commodities that, based on the findings of our risk analyses, APHIS determines can be safely imported subject to one or more of the designated risk management measures.
By eliminating the need for specific prior rulemaking for notice-based process commodities, considerable time savings could be reaped. The current process for approving new imports takes a notable period of time, ranging on average from 18 months to upwards of 3 years (beginning with the initial request and ending with the publication of the final rule). A significant portion of this time is accounted for in the rulemaking process. This rule will reduce the time needed for the administrative portion of the approval process of some fruits and vegetables for import without eliminating opportunity for public participation in our analysis of risk and without affecting the science-based review of the request. In addition, this rule will help relieve the burden on the APHIS regulatory mechanism, given the volume of new commodity import requests APHIS has been receiving, and the large volume of rulemaking initiatives already underway in APHIS.
Consumers benefit from the ability to purchase fruits and vegetables from a variety of sources, foreign as well as domestic. Consumer expenditures for fruit and vegetables are growing faster than for any food group other than meats. Many of the commodities that will be covered by this rule are niche products, currently unavailable or limited in availability in the United States. This rule allows importers to more quickly meet consumer demand for those niche products. In addition, climate causes most domestic fruit and vegetable production to be seasonal, with the largest harvests occurring during the summer and fall. Imports supplement domestic supplies, especially of fresh products during the winter, resulting in increased choices for consumers. Even where the new imports would compete directly with domestic production, consumers would benefit when increased competition results in lower prices.
In the current process, once APHIS has conducted a risk analysis and identified what phytosanitary measures are necessary to address the pest risk posed by the commodity subject to an import request, APHIS then proceeds through rulemaking. Through rulemaking, APHIS amends the fruits and vegetables regulations by listing the commodity from a specific part of the world as eligible, under specified conditions, for importation into the United States. Some import requests that might otherwise have very quickly led to new imports are delayed considerably by the rulemaking process. One reason for this is the complexities of the rulemaking process itself. There are certain statutory, executive branch, and departmental process requirements that are typically not required under a notice-based process. Another is the nature of the requests. Few if any of these requests warrant an entire rulemaking in and of themselves. These requests are primarily for small volume imports either because they are specialty crops or are grown in limited quantities in the requesting area. Therefore these requests, when their risk analyses have been completed and needed phytosanitary measures have been identified, are necessarily grouped together for movement through the rulemaking process. These changes, along with other minor regulatory changes, are covered in rulemakings referred to as periodic amendments to Q56.
A significant number of the commodity import requests that APHIS receives will likely fit the notice-based process criteria as laid out in this rule. The number of import requests has grown significantly. As noted previously, there are currently approximately 400 commodity import requests that are pending before APHIS, of which approximately 70 are awaiting assignment and prioritization and 110 are in various stages of development; the remainding requests are incomplete or otherwise lacking and a response to our inquiries has not yet been received from the requestor. Because of the nature of the import requests likely to qualify for the notice-based approach, those commodities would most likely otherwise be included in periodic amendments to Q56.
Included in the 11th periodic amendment  were numerous herbs from Central America, figs from Mexico, peppers from Chile, cape gooseberry from Colombia, longan from China, persimmon from Spain, yard-long-bean from Nicaragua, and yellow pitaya from Colombia. These commodities would fit the notice-based process criteria of this rule, subject only to designated mitigation measures. Had these commodities followed the notice-based process of this rule, these commodities would have been available to U.S. consumers far sooner than was actually the case. For example, all of the pest risk analyses and risk management decisions associated with the herbs from Central America were completed by the end of 2001. The final rule allowing the import of these commodities was not published and effective until June 25, 2003.
In 2004 and 2005, approximately 454,000 kg of the above commodities were imported into the United States from the countries covered in the amendment. It is estimated that the average monthly value per commodity of these consignments was about $3,900.  A significant percentage of commodity import requests currently being processed by APHIS may fit the notice-based process criteria of this rule. The rulemaking process is an inherently longer process than a notice-based process. There are complexities in the rulemaking process that are not present in the notice-based process. In addition, few if any of the requests that would fall into the notice-based process warrant an entire rulemaking in and of themselves, and are therefore grouped with other commodities for rulemaking. Therefore, a notice-based approach to commodity import approvals could be 6 to 12 months shorter than under a rulemaking approach.
For the purposes of estimating the benefits of a notice-based approach to approving commodity import requests, we make the following assumptions: The commodities that are approved for import under this notice-based process have values similar to those approved under the 11th periodic amendment; 30 to 50 percent (120 to 200) of current commodity import requests would be approved under this process; and those commodities approved in the notice-based process would reach the U.S. market 6 to 12 months earlier than they would under rulemaking.
Based on these assumptions, we could expect imports valued at between $2.8 million and $9.4 million to occur under a notice-based process that would not occur under the current rulemaking process. These added sales represent benefits of this rule. The rule will also have the benefit of improving trade relations with other countries by speeding import approvals. In addition, by moving to a notice-based process for certain commodities, fewer APHIS resources will have to be devoted to rulemaking for these commodities.
This rule does not alter the manner in which the risks associated with a commodity import request are evaluated, nor does it alter the manner in which those risks are ultimately mitigated. The change merely allows a new commodity import to move more quickly into commerce to the benefit of consumers once it has been determined that the commodity can be safely imported subject to one or more designated risk management measures.
APHIS currently recognizes changes in the pest-free status of countries via rulemaking. Under this rule, APHIS will use Federal Register notices and public comment to acknowledge pest-free areas in foreign countries without undertaking rulemaking. This will allow APHIS to be more responsive in recognizing changes in the pest-free status of foreign areas.
This rule also clarifies and strengthens requirements regarding safeguarding of fruits and vegetables that are imported from pest-free areas. These safeguards provide necessary protection of imported commodities against pest infestations while they are in transit to the United States and are consistent with standard operating procedures of all current programs that export fruits and vegetables from pest-free areas. These changes should therefore have little, if any, impact on users of the system.
The commodities approved under the notice-based approach will no longer be listed in the regulations, nor will commodities that are currently approved for importation subject to one or more of the designated measures described previously be listed. Rather, the fruits and vegetables manual  will contain a listing of all commodities approved for importation into the United States and will serve as a comprehensive list and reference of enterable fruits and vegetables. In addition, as stated previously, we are in the process of converting APHIS' fruits and vegetables manual into a searchable database that will allow interested persons to search by commodity or by country, and that will list clearly the conditions that apply to each particular commodity from a specified country. We anticipate having the system operating by the end of 2007.
These changes will not alter the decisionmaking process for determining whether a commodity is approved for importation, merely how that decision is presented.
This rule makes several changes to the issuance of permits for the importation of fruits and vegetables. This rule amends the regulations pertaining to permits to state that certain dried, cured, or processed fruits and vegetables; certain fruits and vegetables grown in Canada; and certain fruits and vegetables grown in the British Virgin Islands that are imported into the U.S. Virgin Islands; may be imported without a permit, while all other fruits and vegetables must be imported under permit. Because this change merely removes an unnecessarily confusing distinction between specific and general written permits, the change should have little, if any, impact on users.
Other current provisions regarding application for permits; issuance of permits; amendment, denial, or withdrawal of permits; and appeals are relocated in this rule. The provisions for applying for permits are also updated to reflect the various means now available for applying for permits. These changes will not affect program operations, and should therefore have little, if any, impact on users of the system.
This rule revises, reorganizes, and updates some of the regulations, updates terms and removes outdated requirements and references, and makes various editorial and nonsubstantive changes to regulations to make them easier to use. The reorganization of the regulations does not affect any requirements for importing commodities but simplifies the regulations and organizes them to facilitate future revisions. In addition, this rule also clarifies treatment requirements in 7 CFR part 305. These changes do not represent a change in program operations and therefore should not affect users of the system.
This rule also amends the various restrictions on the importation of okra from countries where the pink bollworm is known to exist. The regulations were outdated and contained differing restrictions for the importation of okra from countries even though the regulations are all aimed at excluding pink bollworm from the United States. Under this rule, all imports from pink bollworm-infested areas are subject to the same requirements. The conditions are equivalent to our domestic regulations that pertain to pink bollworm.
In 2004, okra was imported from 11 countries into the United States with a value of $17.4 million. Mexico has been the primary source of these imports. In 2004, Mexico accounted for nearly 70 percent of the imports. Other major sources are El Salvador, Honduras, and Nicaragua, which together accounted for the remainder of the okra imports in 2004.
Currently, the regulations contain varying restrictions on the importation of okra from countries where pink bollworm is known to exist. These restrictions include fumigation of imports from pink bollworm infested countries that are moving into infested areas of the United States. This rule removes this restriction. This may reduce the cost associated with some imports. However, this change will primarily impact Mexican imports. Mexico is already, by far, the United States' largest foreign source of okra. In addition, this change only affects a limited portion of those okra imports. Therefore, this change should have at most a minor effect on okra imports and domestic okra prices.
This rule also updates the regulations to reflect current APHIS operating practices regarding biometric sampling of apricots, nectarines, peaches, plumcot, and plums from Chile. Under the rule, the current sampling regimens are removed and replaced with provisions that require sampling, but do not specify the percentage of fruit to be sampled or the confidence level of the inspection. Chile is the primary source of U.S. stone fruit imports, accounting for more than 97 percent $73 million in such imports in 2005. However, these modifications in this rule do not represent a change in current program operations and therefore should not affect users of the system.
In sum, APHIS expects little impact on the total volume of U.S. imports of fruits and vegetables, with small effects on U.S. marketers and consumers. In addition, those additional measures in this rule that affect specific commodities are also expected to have limited impact. The main portions of this rule represent a significant structural revision of the fruits and vegetables import regulations and establish a new process for approving certain new commodities for importation into the United States. However, those commodity import requests most likely to qualify for the notice-based process are for small volume imports. This is either because they are for specialty crops that are currently unavailable or limited in availability in the United States, or are for crops grown in limited quantities in the requesting area. In addition, the rule does not alter the conditions for importing the majority of currently approved fruits or vegetables.
Of particular note with respect to the changes to the approval process, the change merely allows a new commodity import to move more quickly into commerce to the benefit of consumers once it has been determined that the commodity can be safely imported subject to one or more designated risk management measures. The rule does not alter the manner in which the risk associated with a commodity import request is evaluated, nor does it alter the manner in which those risks are ultimately mitigated. Consumers will have quicker access to imported fruits and vegetables, though risks will still be evaluated and appropriate mitigations required, as they are currently. Also, given the growing number of requests to ship foreign fruits and vegetables to the United States, some trading partners may perceive the time required to conduct the rulemaking process as a barrier to trade. Such perception may impede their consideration of U.S. requests to ship U.S. commodities to their markets. To the extent our trading partners consider the time it takes to conduct the rulemaking process a trade barrier, as many of them do, this rule may facilitate the export of U.S. agricultural commodities.
Summary of Regulatory Flexibility Analysis Back to Top
Objectives of and Legal Basis
By eliminating the need for specific prior rulemaking for notice-based process commodities, considerable time savings could be reaped. The current process for approving new imports takes a notable period of time, ranging on average from 18 months to 3 years (beginning with the initial request and ending with the publication of the final rule).
Consumers benefit from the ability to purchase fruits and vegetables from a variety of sources, foreign as well as domestic. Many of the commodities that likely to be covered by this rule are niche products, unavailable or limited in availability in the United States. This rule will allow importers to more quickly meet consumer demand for those niche products. In addition, climate causes most domestic fruit and vegetable production to be seasonal, with the largest harvests occurring during the summer and fall. Imports supplement domestic supplies, especially of fresh products during the winter, resulting in increased choices for consumers. Even where the new imports would compete directly with domestic production, consumers would benefit when increased competition results in lower prices.
Under the regulations in “Subpart-Fruits and Vegetables,” APHIS prohibits or restricts the importation of fresh fruits and vegetables into the United States from certain parts of the world to prevent the introduction and spread of plant pests that are new to or not widely distributed within the United States. Those regulations are based on our authority under the Plant Protection Act.
Significant Issues Raised by Public Comments
In accordance with 5 U.S.C. 603, we prepared an initial regulatory flexibility analysis for the interim rule. We invited comments about the interim rule as it relates to small entities and stated that we were interested in determining the number and kind of small entities that may incur benefits or costs from implementation of the interim rule. We did not receive any comments that were responsive to our request for additional economic information.
Description and Estimate of Small Entities
Those entities most likely to be economically affected by the rule are domestic importers and producers of fruits and vegetables. The Small Business Administration (SBA) has established guidelines for determining which establishments are to be considered small. Import/export merchants, agents, and brokers are identified within the broader wholesaling trade sector. A firm primarily engaged in wholesaling fresh fruits and vegetables is considered small if it employs not more than 100 persons. In 1997,  more than 96 percent (5,456 of 5,657) of fresh fruit and vegetable wholesalers would be considered small by SBA standards.  All types of fruit and vegetable farms are considered small if they have annual receipts of $0.75 million or less. With some exceptions, vegetable and melon farms are largely individually owned and relatively small, with two-thirds harvesting fewer than 25 acres. In 2002, between 80 and 84 percent of vegetable and melon farms would be considered small. Similarly, although numbers have declined, fruit and tree nut production is still dominated by small family or individually run farm operations. In 2002, between 92 and 95 percent of all fruit and tree nut farms would be considered small. 
The number of entities that will be affected by this rule is unknown but those affected would likely be considered small entities. However, based on the information that is available, the effects of this rule should be small whether the entity affected is small or large. Those commodity import requests most likely to qualify for the notice-based process are for small volume imports. This is either because they are for specialty crops currently unavailable or limited in availability in the United States, or are for crops grown in limited quantities in the requesting area. This rule merely allows a new commodity import to move more quickly into commerce to the benefit of consumers once it has been determined that the commodity can be safely imported subject to one or more designated risk management measures. Hence, we expect little impact on the total volume of U.S. imports of fruits and vegetables, with small effects on U.S. marketers and consumers.
Reporting, Recordkeeping, and Other Compliance Requirements for Small Entities
These requirements are addressed in the proposed rule and later in this document under the heading “Paperwork Reduction Act.”
One alternative to this rule considered was to simply continue under APHIS' current process of authorizing the importation of fruits and vegetables. In this case, we would continue to list all newly approved fruits and vegetables in the regulations through notice-and-comment rulemaking, as we have been doing since 1987. This approach is no longer satisfactory, because the number of requests we receive from foreign exporters and domestic importers to amend the regulations has been steadily increasing. Maintaining the current process will make it difficult to keep pace with the volume of import requests. Therefore, this alternative was rejected. We believe that the new approach will enable us to be more responsive to the import requests of our trading partners while maintaining the transparency of our decisionmaking afforded by notice-and-comment rulemaking.
Prior to 1987, APHIS authorized the importation of a fruit or vegetable by simply issuing a permit once the Agency was satisfied that the relevant criteria in the regulations had been met. Another alternative to this rule was to return to this method of authorizing fruit and vegetable importations. This approach is unsatisfactory, because it does not provide the opportunity for public analysis of and comment on the science associated with such imports. Therefore, this alternative was rejected. Again, we believe that the new approach will enable us to be more responsive to the import requests of our trading partners while maintaining the transparency of our decisionmaking afforded by notice-and-comment rulemaking.
Executive Orders 12988 and 13132 Back to Top
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform, and Executive Order 13132, Federalism. This rule: (1) Preempts all State and local laws and regulations that are inconsistent with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
Because the rule's preemptive effect is derived from an express statutory provision, this rule does not have federalism implications within the meaning of Executive Order 13132, and therefore does not warrant the preparation of a federalism summary impact statement.
Specifically, pursuant to section 436 of the Plant Protection Act, no 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 to control a plant pest or noxious weed, to eradicate a plant pest or noxious weed, or to prevent the introduction or dissemination of a biological control organism, plant pest, or noxious weed. State and local laws and regulations regarding fruits and vegetables imported under the provisions of this rule are preempted. USDA's longstanding interpretation of the scope of the preemption remains unchanged. Because fresh fruits and vegetables are generally imported for immediate distribution and sale to the consuming public, they remain in foreign commerce until sold to the ultimate consumer.
National Environmental Policy Act Back to Top
The majority of the regulatory changes in this document are nonsubstantive, and would therefore have no effects on the environment. However, this rule will allow APHIS to approve certain new fruits and vegetables for importation into the United States without undertaking rulemaking. Despite the fact that those fruits and vegetable imports will no longer be contingent on the completion of rulemaking, the requirements of the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq.) will still apply. As such, for each additional fruit or vegetable approved for importation, APHIS will make available to the public documentation related to our analysis of the potential environmental effects of such new imports. This documentation will likely be made available at the same time and via the same Federal Register notice as the risk analysis for the proposed new import.
Paperwork Reduction Act Back to Top
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this rule have been approved by the Office of Management and Budget (OMB) under OMB control number 0579-0293.
E-Government Act Compliance Back to Top
APHIS is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.
Lists of Subjects Back to Top
Accordingly, we are amending 7 CFR chapter III as follows:
PART 305—PHYTOSANITARY TREATMENTS Back to Top
1.The authority citation for part 305 continues to read as follows:
§ 305.2 [Amended]
2.In § 305.2, paragraph (h)(2)(i), the table is amended as follows:
a. In the entry for acorns and chestnuts from all countries, by removing the reference to “§ 319.56-2b” and adding a reference to “§ 319.56-11” in its place.
b. In the entry for yam from all countries, by removing the words “(see § 319.56-2l of this chapter)”.
c. In the entry for papaya from Belize, by removing the words “(see § 319.56-2(j) of this part)”.
d. In the entry for cherimoya from Chile, by removing the words “(see § 319.56-2z of this chapter for additional treatment information)”.
3.A new § 305.3 is added to read as follows:
§ 305.3 Monitoring and certification of treatments.
(a) All treatments approved under part 305 are subject to monitoring and verification by APHIS.
(b) Any treatment performed outside the United States must be monitored and certified by an inspector or an official from the national plant protection organization (NPPO) of the exporting country. If monitored and certified by an official of the NPPO of the exporting country, the treated commodities must be accompanied by a phytosanitary certificate issued by the NPPO of the exporting country certifying that treatment was applied in accordance with APHIS regulations. The phytosanitary certificate must be provided to an inspector when the commodity is offered for entry into the United States. During the entire interval between treatment and export, the consignment must be stored an