2016-08189. Importation of Fresh Pitahaya Fruit From Ecuador Into the Continental United States

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

We are proposing to amend the fruits and vegetables regulations to allow the importation of fresh pitahaya fruit into the continental United States from Ecuador. As a condition of entry, the fruit would have to be produced in accordance with a systems approach that would include requirements for fruit fly trapping, pre-harvest inspections, approved production sites, and packinghouse procedures designed to exclude quarantine pests. The fruit would also be required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization of Ecuador stating that the consignment was produced and prepared for export in accordance with the requirements of the systems approach. This action would allow for the importation of fresh pitahaya from Ecuador while continuing to provide protection against the introduction of plant pests into the United States.

DATES:

We will consider all comments that we receive on or before June 7, 2016.

ADDRESSES:

You may submit comments by either of the following methods:

• Federal eRulemaking Portal: Go to http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2015-0004.
• Postal Mail/Commercial Delivery: Send your comment to Docket No. APHIS-2015-0004, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-1238.

Supporting documents and any comments we receive on this docket may be viewed at http://www.regulations.gov/​#!docketDetail;​D=​APHIS-2015-0004 or in our reading room, which is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming.

FOR FURTHER INFORMATION CONTACT:

Ms. Claudia Ferguson, M.S., Senior Regulatory Policy Specialist, Regulatory Coordination and Compliance, Imports, Regulations and Manuals, PPQ, APHIS, [phone]; email: [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The regulations in “Subpart-Fruits and Vegetables” (7 CFR 319.56-1 through 319.56-75, referred to below as the regulations) prohibit or restrict the importation of fruits and vegetables into the United States from certain parts of the world to prevent the introduction and dissemination of plant pests. The regulations currently do not authorize the importation of fresh pitahaya fruit (sometimes referred to as “dragon fruit”) from Ecuador.

The national plant protection organization (NPPO) of Ecuador has requested that the Animal and Plant Health Inspection Service (APHIS) amend the regulations in order to allow fresh fruit of any color of pitahaya (Hylocereus spp., Acanthocereus spp., Cereus spp., Echinocereus spp., Escontria spp., Myrtillocactus spp., and Stenocereus spp.) to be imported into the continental United States. (Hereafter we refer to these species as “pitahaya.”)

As part of our evaluation of Ecuador's request, we prepared a pest risk assessment (PRA) and a risk management document (RMD). Copies of the PRA and the RMD may be obtained from the person listed under FOR FURTHER INFORMATION CONTACT or viewed on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

The PRA, titled “Importation of Pitahaya from Ecuador into the Continental United States (August 2013),” evaluates the risks associated with the importation of fresh pitahaya fruit from Ecuador into the United States. The RMD relies upon the findings of the PRA to determine the phytosanitary measures necessary to ensure the safe importation into the continental United States of fresh pitahaya from Ecuador.

The PRA identifies one quarantine pest present in Ecuador that could be introduced into the United States through the importation of fresh pitahaya: Anastrepha fraterculus (Wiedemann), South American fruit fly.

A quarantine pest is defined in § 319.56-2 of the regulations as a pest of potential economic importance to the area endangered thereby and not yet present there, or present but not widely distributed and being officially controlled. Potential plant pest risks associated with the importation of fresh pitahaya from Ecuador into the continental United States were determined by estimating the consequences and likelihood of introduction of quarantine pests into the United States and ranking the risk potential as high, medium, or low. The PRA rated the insect A. fraterculus as having a high pest risk potential for following the pathway of fresh pitahaya from Ecuador into the continental United States.

APHIS has determined that measures beyond standard port of arrival inspection are required to mitigate the risks posed by this plant pest. Therefore, we are proposing to allow the importation of fresh pitahaya from Ecuador into the continental United States produced under a systems approach. The RMD prepared for fresh pitahaya from Ecuador identifies a systems approach of specific mitigation measures against the quarantine pest identified in the PRA and concludes that those measures, along with the general requirements for the importation of fruits and vegetables in the regulations, will be sufficient to prevent the introduction of this pest into the United States. Therefore, we are proposing to add the systems approach to the regulations in a new § 319.56-76. The proposed measures are described below.

General Requirements

Paragraph (a) of proposed § 319.56-76 would require the NPPO of Ecuador to provide an operational workplan to APHIS that details the activities that the NPPO would, subject to APHIS' approval of the workplan, carry out to meet the requirements of proposed § 319.56-76. An operational workplan is an agreement developed between APHIS' Plant Protection and Quarantine program, officials of the NPPO of a foreign government, and, when necessary, foreign commercial entities, that specifies in detail the phytosanitary measures that will be carried out to comply with our regulations governing the importation of a specific commodity. Operational workplans apply only to the signatory parties and establish detailed procedures and guidance for the day-to-day operations of specific import/export programs. Operational workplans also establish how specific phytosanitary issues are dealt with in the exporting country and make clear who is responsible for dealing with those issues. The implementation of a systems approach typically requires an operational workplan to be developed.

Paragraph (b) of proposed § 319.56-76 would require fresh pitahaya from Ecuador to be imported in commercial consignments only. Produce grown commercially is less likely to be infested with plant pests than noncommercial consignments. Noncommercial consignments are more prone to infestations because the commodity is often ripe to overripe, could be of a variety with unknown susceptibility to pests, and is often grown with little or no pest control.

Production Site Requirements

Paragraph (c)(1) of proposed § 319.56-76 would require that all production sites participating in the fresh pitahaya export program be approved by and registered with the NPPO of Ecuador in accordance with the requirements of the operational workplan. Such registration would facilitate traceback of a consignment of pitahayas to the production site in the event that quarantine pests were discovered in the consignment at the packinghouse, or at the first port of arrival into the United States.

Paragraph (c)(2) of proposed § 319.56-76 would require that trees and other structures, other than the crop itself, not shade the crop during the day. No other host of A. fraterculus would be permitted to be grown within 100 meters of the edge of the field. Pitahaya fruit that has fallen on the ground would have to be removed from the place of production at least once every 7 days and may not be included in field containers of fruit to be packed for export. Harvested pitahayas would have to be placed in field cartons or containers that are marked to show the place of production so that traceback is possible.

Paragraph (c)(3) of proposed § 319.56-76 would require the NPPO of Ecuador or its approved designee ^[1] to visit and inspect the production sites prior to each harvest in accordance with the operational workplan. APHIS may also monitor the places of production if necessary. If APHIS or the NPPO of Ecuador finds that a place of production is not complying with the requirements of the systems approach, no fruit from the place of production will be eligible for export to the continental United States until APHIS and the NPPO of Ecuador conduct an investigation and appropriate remedial actions have been implemented.

Paragraph (c)(4) of proposed § 319.56-76 would require trapping for the fruit fly A. fraterculus at each production site in accordance with the operational workplan. The NPPO of Ecuador would have to certify that exporting places of production have effective fruit fly trapping programs and follow control guidelines, when necessary, to reduce regulated pest populations. Personnel conducting the trapping and pest surveys would need to be hired, trained, and supervised by the NPPO of Ecuador. The trapping would have to begin at least 1 year before harvest begins and continue through the completion of harvest.

Paragraph (c)(5) would state that, if more than an average of 0.07 A. fraterculus per trap per day is trapped for more than 2 consecutive weeks, the production site would be ineligible for export until the rate of capture drops to less than that average. If levels exceed that average, from 2 months prior to harvest to the end of the shipping season, the production site would be prohibited from shipping under the systems approach until APHIS and the NPPO of Ecuador both agree that the pest risk has been mitigated. As conditions warrant, the average number of A. fraterculus per trap per day may be raised or lowered if jointly agreed to between APHIS and the NPPO of Ecuador in the operational workplan.

Paragraph (c)(6) of proposed § 319.56-76 would require the NPPO of Ecuador to maintain records of trap placement, trap checks, and any quarantine pest captures in accordance with the operational workplan. Trapping records would have to be maintained for APHIS' review for at least 1 year.

Packinghouse Requirements

We are proposing several requirements for packinghouse activities, which would be contained in paragraph (d) of proposed § 319.56-76.

Paragraph (d)(1) would state that the NPPO of Ecuador must monitor packinghouse operations to verify that the packinghouses are complying with the requirements of the systems approach. If the NPPO of Ecuador finds that a packinghouse is not complying with the requirements of the systems approach, no pitahaya fruit from the packinghouse will be eligible for export to the continental United States until APHIS and the NPPO of Ecuador conduct an investigation and both agree that the pest risk has been mitigated.

Paragraph (d)(2) would require that fresh pitahaya be packed in a packinghouse registered with the NPPO of Ecuador. Such registration would facilitate traceback of a consignment of pitahaya fruit to the packinghouse in which it was packed in the event that quarantine pests were discovered in the consignment at the port of first arrival into the United States.

Paragraph (d)(3) would require that the pitahaya be packed within 24 hours of harvest in a pest-exclusionary packinghouse that meets the requirements of the operational workplan. The pitahaya would have to be safeguarded by an insect-proof mesh screen or plastic tarpaulin while in transit to the packinghouse and while awaiting packing. These safeguards would have to remain intact until arrival in the continental United States or the consignment would be denied entry.

Paragraph (d)(4) of proposed § 319.56-76 would require that during the time that the packinghouse is in use for exporting fresh pitahayas to the continental United States, the packinghouse would only be allowed to accept pitahayas from registered production sites. This requirement would prevent such pitahayas intended for export to the continental United States from being exposed to or otherwise mixed with pitahayas that are not produced according to the requirements of the systems approach.

Phytosanitary Inspection

Paragraph (e)(1) of proposed § 319.56-76 would require that a biometric sample of pitahaya fruit jointly agreed upon by APHIS and the NPPO of Ecuador would need to be inspected in Ecuador by the NPPO of Ecuador following post-harvest processing. The biometric sample would be visually inspected for any quarantine pests, and a portion of the fruit would be cut open to detect internal signs of A. fraterculus.

Paragraph (e)(2) would require that fruit presented for inspection at the port of entry to the United States be identified in the shipping documents accompanying each lot of fruit to specify the production site or sites, in which the fruit was produced, and the packing shed or sheds, in which the fruit was processed, in accordance with the requirements in the operational workplan. This identification would need to be maintained until the fruit is released for entry into the continental United States. The pitahaya fruit are subject to inspection at the port of entry for all quarantine pests of concern, including A. fraterculus. If a single larva of A. fraterculus is found in a shipment from a place of production (either by the NPPO in Ecuador or by inspectors at the continental United States port of entry), the entire lot of fruit would be prohibited from entry into the United States, and the place of production of that fruit would be suspended from the export program until appropriate measures, as agreed upon by the NPPO of Ecuador and APHIS, have been taken.

Phytosanitary Certificate

To certify that the fresh pitahaya fruit from Ecuador has been grown and packed in accordance with the requirements of proposed § 319.56-76, paragraph (f) would require each consignment of fruit to be accompanied by a phytosanitary certificate issued by the NPPO of Ecuador, with an additional declaration stating that the fruit in the consignment was produced and prepared for export in accordance with the requirements of § 319.56-76.

Executive Order 12866 and Regulatory Flexibility Act

The proposed rule has been determined to be Not Significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

In accordance with 5 U.S.C. 603, we have performed an initial regulatory flexibility analysis, which is summarized below, regarding the economic effects of this proposed rule on small entities. Copies of the full analysis are available by contacting the person listed under FOR FURTHER INFORMATION CONTACT or on the Regulations.gov Web site (see ADDRESSES above for instructions for accessing Regulations.gov).

Based on the information we have, there is no reason to conclude that adoption of this proposed rule would result in any significant economic effect on a substantial number of small entities. However, we do not currently have all of the data necessary for a comprehensive analysis of the effects of this proposed rule on small entities. Therefore, we are inviting comments on potential effects. In particular, we are interested in determining the number and kind of small entities that may incur benefits or costs from the implementation of this proposed rule.

The proposed rule would amend the regulations to allow the importation of fresh pitahaya (of any color) (Hylocereus spp., Acanthocereus spp., Cereus spp., Echinocereus spp., Escontria spp., Myrtillocactus spp., and Stenocereus spp.) from Ecuador into the continental United States under a systems approach. Entities potentially affected by the proposed rule are U.S. pitahaya fruit growers, of which most, if not all, are small entities.

APHIS has been marginally successful in acquiring information on the U.S. market for pitahaya fruit. At this point, we do not know the quantity of pitahaya fruit domestically produced, numbers of U.S. producers, the total quantity imported, or other factors needed to assess likely economic effects of this rule. Vietnam, the largest exporter of pitahaya to the United States, shipped 1,300 metric tons of the fruit to the United States in 2013. It is unknown what percentage of the total supply this represents. Domestically, pitahaya fruit is produced in Hawaii, California, and Florida. Hawaii's pitahaya production is mainly consumed within that State.

The quantity of pitahaya fruit that would be imported from Ecuador is unknown. In 2014, Ecuador exported about 165 metric tons of pitahaya to 32 countries. They have indicated that, if this proposed rule is finalized, they expect to divert 147 shipments to the United States per year. Given that there is no consistent indication of the expected individual size of these shipments, it is unknown what percentage of the total exported tonnage this would represent, or the total quantity of these shipments. Lack of information about the quantity of pitahaya fruit that would be imported, and about the quantities produced by the United States, prevents a clear understanding of what the economic effects of the proposed rule may be.

Executive Order 12988

This proposed rule would allow fresh pitahaya to be imported into the continental United States from Ecuador. If this proposed rule is adopted, State and local laws and regulations regarding fresh pitahaya imported under this rule would be preempted while the fruit is in foreign commerce. Fresh fruit are generally imported for immediate distribution and sale to the consuming public and would remain in foreign commerce until sold to the ultimate consumer. The question of when foreign commerce ceases in other cases must be addressed on a case-by-case basis. If this proposed rule is adopted, no retroactive effect will be given to this rule, and this rule will not require administrative proceedings before parties may file suit in court challenging this rule.

Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2015-0004. Please send a copy of your comments to: (1) APHIS, using one of the methods described under ADDRESSES at the beginning of this document, and (2) Clearance Officer, OCIO, USDA, Room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250.

APHIS is proposing to amend the fruits and vegetables regulations to allow the importation of fresh pitahaya fruit into the continental United States from Ecuador. As a condition of entry, the fruit would have to be produced in accordance with a systems approach that would include requirements for fruit fly trapping, pre-harvest inspections, production sites, and packinghouse procedures designed to exclude quarantine pests. The fruit would also be required to be imported in commercial consignments and be accompanied by a phytosanitary certificate issued by the NPPO of Ecuador stating that the consignment was produced and prepared for export in accordance with the requirements in the systems approach.

This action would allow for the importation of fresh pitahaya fruit from Ecuador while continuing to provide protection against the introduction of plant pests into the United States.

Allowing the importation of fresh pitahaya fruit into the continental United States from Ecuador would require an operational workplan, registered production sites, trapping records, inspections, monitoring, packinghouse registrations, box labeling, shipping documents, and phytosanitary certificates.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.003 hours per response.

Respondents: NPPO of Ecuador, producers, and exporters.

Estimated annual number of respondents: 132.

Estimated annual number of responses per respondent: 1,367.

Estimated annual number of responses: 180,561.

Estimated total annual burden on respondents: 673 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at [phone].

E-Government Act Compliance

The Animal and Plant Health Inspection Service is committed to compliance with the EGovernment 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 proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at [phone].

International Trade Data System

The Security and Accountability for Every Port Act of 2006 ^[2] (“SAFE Act”) requires the interagency establishment of a single portal system, known as the International Trade Data System (ITDS), to be operated by U.S. Customs and Border Protection. This unified data system electronically collects and distributes import and export data required by government agencies that license or clear the import or export of goods. ITDS provides individuals and companies involved in the international trade of plants and plant products, including pitahaya from Ecuador, with an electronic format to secure necessary certifications, complete required forms, and provide information about the requirements and regulations relevant to the commodity of interest.

List of Subjects in 7 CFR Part 319

• Coffee
• Cotton
• Fruits
• Imports
• Logs
• Nursery stock
• Plant diseases and pests
• Quarantine
• Reporting and recordkeeping requirements
• Rice
• Vegetables

Accordingly, we propose to amend 7 CFR part 319 as follows:

PART 319—FOREIGN QUARANTINE NOTICES

1. The authority citation for part 319 continues to read as follows:

Authority: 7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.

2. Section 319.56-76 is added to read as follows:

§ 319.56-76

Pitahaya from Ecuador.

Fresh pitahaya (Hylocereus spp., Acanthocereus spp., Cereus spp., Echinocereus spp., Escontria spp., Myrtillocactus spp., and Stenocereus spp.) from Ecuador may be imported into the continental United States only under the conditions described in this section. These conditions are designed to prevent the introduction of the following quarantine pest: Anastrepha fraterculus (Wiedemann), South American fruit fly.

(a) General requirements. The national plant protection organization (NPPO) of Ecuador must provide an operational workplan to APHIS that details activities that the NPPO of Ecuador will, subject to APHIS' approval of the workplan, carry out to meet the requirements of this section. The operational workplan must include and describe the specific requirements as set forth in this section.

(b) Commercial consignments. Pitahaya from Ecuador may be imported in commercial consignments only.

(c) Production site requirements. (1) All production sites that participate in the pitahaya export program must be approved by and registered with the NPPO of Ecuador in accordance with the operational workplan.

(2) Trees and other structures, other than the crop itself, must not shade the crop during the day. No other host of A. fraterculus is permitted to be grown within 100 meters of the edge of the field. Pitahaya fruit that has fallen on the ground must be removed from the place of production at least once every 7 days and may not be included in field containers of fruit to be packed for export. Harvested pitahayas must be placed in field cartons or containers that are marked to show the place of production so that traceback is possible.

(3) The production sites must be inspected prior to each harvest by the NPPO of Ecuador or its approved designee in accordance with the operational workplan. An approved designee is an entity with which the NPPO creates a formal agreement that allows that entity to certify that the appropriate procedures have been followed. If APHIS or the NPPO of Ecuador finds that a place of production is not complying with the requirements of the systems approach, no fruit from the place of production will be eligible for export to the continental United States until APHIS and the NPPO of Ecuador conduct an investigation and appropriate remedial actions have been implemented.

(4) The registered production sites must conduct trapping for the fruit fly A. fraterculus at each production site in accordance with the operational workplan. Personnel conducting the trapping and pest surveys must be hired, trained, and supervised by the NPPO of Ecuador. The trapping must begin at least 1 year before harvest begins and continue through the completion of harvest.

(5) If more than an average of 0.07 A. fraterculus per trap per day is trapped for more than 2 consecutive weeks, the production site will be ineligible for export until the rate of capture drops to less than that average. If levels exceed that average per trap per day, from 2 months prior to harvest to the end of the shipping season, the production site will be prohibited from shipping under the systems approach until APHIS and the NPPO of Ecuador both agree that the pest risk has been mitigated. As conditions warrant, the average number of A. fraterculus per trap per day may be raised or lowered if jointly agreed to between APHIS and the NPPO of Ecuador in the operational workplan.

(6) The NPPO of Ecuador must maintain records of trap placement, checking of traps, and any quarantine pest captures in accordance with the operational workplan. Trapping records must be maintained for APHIS review for at least 1 year.

(d) Packinghouse requirements. (1) The NPPO of Ecuador must monitor packinghouse operations to verify that the packinghouses are complying with the requirements of the systems approach. If the NPPO of Ecuador finds that a packinghouse is not complying with the requirements of the systems approach, no pitahaya fruit from the packinghouse will be eligible for export to the continental United States until APHIS and the NPPO of Ecuador conduct an investigation and both agree that the pest risk has been mitigated.

(2) All packinghouses that participate in the pitahaya export program must be registered with the NPPO of Ecuador.

(3) The pitahaya fruit must be packed within 24 hours of harvest in a pest-exclusionary packinghouse. The pitahaya must be safeguarded by an insect-proof mesh screen or plastic tarpaulin while in transit to the packinghouse and while awaiting packing. These safeguards must remain intact until arrival in the continental United States or the consignment will be denied entry.

(4) During the time the packinghouse is in use for exporting pitahaya fruit to the continental United States, the packinghouse may only accept pitahaya fruit from registered production sites.

(e) Phytosanitary inspection. (1) A biometric sample of pitahaya fruit (jointly agreed upon by APHIS and the NPPO) must be inspected in Ecuador by the NPPO of Ecuador following post-harvest processing. The biometric sample must be visually inspected for any quarantine pests, and a portion of the fruit will be cut open to detect internal signs of A. fraterculus.

(2) Pitahaya fruit presented for inspection at the port of entry to the United States must be identified in the shipping documents accompanying each lot of fruit to specify the production site or sites, in which the fruit was produced, and the packing shed or sheds, in which the fruit was processed, in accordance with the requirements in the operational workplan. This identification must be maintained until the fruit is released for entry into the continental United States. The pitahaya fruit are subject to inspection at the port of entry for all quarantine pests of concern, including A. fraterculus. If a single larva of A. fraterculus is found in a shipment from a place of production (either by the NPPO in Ecuador or by inspectors at the continental United States port of entry), the entire lot of fruit will be prohibited from export, and the place of production of that fruit will be suspended from the export program until appropriate measures agreed upon by the NPPO of Ecuador and APHIS have been taken.

(f) Phytosanitary certificate. Each consignment of pitahaya fruit must be accompanied by a phytosanitary certificate issued by the NPPO of Ecuador bearing the additional declaration that the consignment was produced and prepared for export in accordance with the requirements of § 319.56-76.

Done in Washington, DC, this 5th day of April 2016.

Kevin Shea,

Administrator, Animal and Plant Health Inspection Service.

Footnotes

1.  An approved designee is an entity with which the NPPO creates a formal agreement that allows that entity to certify that the appropriate procedures have been followed. The approved designee can be a contracted entity, a coalition of growers, or the growers themselves.

2.  Public Law 109-347, October 13, 2006.