[Federal Register Volume 61, Number 142 (Tuesday, July 23, 1996)] [Proposed Rules] [Pages 38108-38114] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-18461] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Animal and Plant Health Inspection Service 7 CFR Part 318 [Docket No. 95-069-1] Papaya, Carambola, and Litchi From Hawaii AGENCY: Animal and Plant Health Inspection Service, USDA. ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: We are proposing to increase the irradiation treatment dose required for papayas intended for interstate movement from Hawaii and to allow carambolas and litchis to be moved interstate from Hawaii with irradiation treatment. We are also proposing to allow papayas, carambolas, and litchis from Hawaii to undergo irradiation treatment either in Hawaii or in non-fruit fly supporting areas of the mainland United States. We are also proposing to allow litchis to be moved interstate from Hawaii if they are inspected and found free of the litchi fruit moth and undergo hot water treatment for fruit flies. In addition, we are proposing several amendments to the requirements for irradiation procedures and facilities and the handling of treated and untreated fruits and vegetables. Finally, we are proposing to amend the definition for inspector to include State plant regulatory officials designated by the Administrator of the Animal and Plant Health Inspection Service, U.S. Department of Agriculture. These proposed actions would facilitate the interstate movement of papayas, carambolas, and litchis from Hawaii while continuing to provide protection against the spread of injurious plant pests from Hawaii to other parts of the United States. DATES: For comments on all portions of this proposed rule except the rule's information collection and recordkeeping requirements that are subject to the Paperwork Reduction Act, consideration will be given only to comments received on or before August 22, 1996. For comments on the Paperwork Reduction Act requirements of this proposed rule, consideration will be given only to comments received on or before September 23, 1996. ADDRESSES: Please send an original and three copies of your comments to Docket No. 95-069-1, Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. 95-069-1. Comments received may be inspected at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect comments are requested to call ahead on (202) 690-2817 to facilitate entry into the comment reading room. FOR FURTHER INFORMATION CONTACT: Mr. Peter M. Grosser, Senior Staff Officer, Port Operations, PPQ, APHIS, 4700 River Road Unit 139, Riverdale, MD 20737-1236, (301) 734-8295. SUPPLEMENTARY INFORMATION: Background The Hawaiian Fruits and Vegetables regulations, contained in 7 CFR 318.13 through 318.13-17 (referred to below as the regulations), govern, among other things, the interstate movement of fruits and vegetables, including papayas, from Hawaii. Regulation is necessary to prevent the spread of the Mediterranean fruit fly (Ceratitis capitata), the melon fly (Bactrocera cucurbitae), and the Oriental fruit fly (Bactrocera dorsalis), which occur in Hawaii. These types of fruit flies are collectively referred to in this document as Trifly. The regulations allow papayas to be moved interstate from Hawaii to any destination in the United States if, [[Page 38109]] among other things, they have been treated for Trifly. One approved treatment for Trifly in papayas is irradiation. Section 318.13-4f provides for irradiation of papayas at an approved facility in Hawaii at an irradiation dose of 150 Gray (15 krad). Irradiation Dosage Levels The Agricultural Research Service (ARS), United States Department of Agriculture, recently reevaluated the irradiation treatment for fruits and vegetables, including papayas, and has formally recommended a change from 150 Gray to 250 Gray for the dose necessary to control Trifly. At the current dosage levels, normal-appearing, sterile adult pests may emerge after treatment. Although these insects cannot reproduce, the emergence of normal-appearing adults presents problems for surveillance programs designed to intercept exotic insects, because there is no practical way to distinguish an irradiated (sterile) insect from an untreated one. ARS has determined that the 250 Gray (25 krad) dosage would prevent adult emergence altogether, including the emergence of normal-appearing, sterile adult insects capable of flight. The Food and Drug Administration (FDA) regulations permit the use of irradiation at doses not to exceed 1,000 Gray (100 krad) to inhibit the growth and maturation of fresh foods and to disinfest food of arthropod pests. The 250 Gray (25 krad) dosage recommended by ARS is well within FDA limits. We are therefore proposing to amend Sec. 318.13-4f by increasing the irradiation treatment dose required for papayas intended for interstate movement from Hawaii from 150 Gray (15 krad) to 250 Gray (25 krad). Irradiation Treatment on the Mainland Hawaii has not been able to ship irradiated fresh papayas to the mainland under the existing regulations due to the lack of an irradiation facility in the State. We believe that routine commercial shipments of papayas can be authorized for treatment in any State of the continental United States except Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Tennessee, Texas, or Virginia. Prior to treatment, movement into and through the United States would be limited to the area authorized under Sec. 318.13-17(e) for fruits and vegetables from Hawaii that transit the United States en route to a foreign destination. It is unlikely that Trifly would be able to establish reproducing populations in the States on the mainland where treatment would be allowed because of either the relatively cool climate or the lack of suitable host material in those areas. Therefore, we are proposing to amend the regulations at Sec. 318.13-3 and 318.13-4f to allow untreated papayas from Hawaii to undergo irradiation treatment in the areas of the mainland United States described above. We are also proposing to require that untreated papayas moved interstate from Hawaii for treatment at an irradiation facility in an approved area on the mainland United States be accompanied by a limited permit. The purpose of a limited permit is to allow movement, under certain restrictions, of a commodity that may not otherwise be authorized for movement. This document provides a way to track the commodity and ensure that it moves only as authorized. In addition, we are proposing to prohibit the commingling of untreated papayas shipped from Hawaii to the mainland United States with other fruits and vegetables. This appears necessary to prevent other commodities from becoming infested with Trifly. Irradiation Procedures and Facilities We are proposing to amend Sec. 318.13-4f to eliminate the requirement that dose indicators be attached to the cartons or the pallet loads of treated papayas. Instead, we would require that absorbed dose be measured at the treatment facility using a dose indicator that can accurately measure an absorbed dose of 250 Gray (25 krad). We would require that the number and placement of dosimeters used to measure the absorbed dose be in accordance with standards of the American Society for Testing and Materials (ASTM). (See Designation E 1261-94, ``Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing,'' American Society for Testing and Materials, Annual Book of ASTM Standards.) We would add that the dosimetry system (the system used for determining absorbed dose, consisting of dosimeters, measurement instruments, reference standards, and procedures) in place at the treatment facility must demonstrate that the absorbed dose, including areas of minimum and maximum dose, is mapped, controlled, and recorded, and we would rely on the treatment facility records to verify the treatment. Under the current regulations, the treatment facility is required to maintain records of treatment for a period of time that exceeds the shelf life of the irradiated product by 1 year. The regulations require the records to include the lot identification, scheduled process, evidence of compliance with the scheduled process, ionizing energy source, source calibration, dosimetry, dose distribution in the product, and the date of irradiation. All records must be available for inspection. In addition, we are proposing to amend Sec. 318.13-4f to require that approved irradiation treatment facilities be certified annually by Plant Protection and Quarantine (PPQ), APHIS, and that they be recertified in the event that an increase or decrease in radioisotope or a major equipment modification affects the delivered dose. This action would ensure that irradiation facilities are capable of properly administering effective treatments. Packaging Requirements We are proposing to amend specific provisions regarding packaging and wrapping of papayas under Sec. 318.13-4f to require that all treated papayas be packaged in pest-proof cartons to protect them from re-infestation by Trifly. Then, to ensure that no cartons are added to or removed from a pallet load of cartons, pallet loads would have to be wrapped in one of the following ways, as is currently required under Sec. 318.13-4f(b)(6): With polyethylene sheet wrap, with net wrapping, or with strapping so that each carton on an outside row of the pallet load is constrained by a metal or plastic strap. We further propose to require that pallet loads of treated papayas be marked with treatment lot numbers, packing and treatment facility identification and locations, and dates of packing and treatment. This information would allow an inspector to identify the treatment lots and trace them back to the packing and treatment facilities. This method of labeling would replace the current requirement that individual cartons and pallet- loads of cartons be marked with a ``Treated'' stamp. We are not proposing similar packaging requirements for untreated papayas moving interstate to the mainland United States. Any Trifly that might be present in the shipment of untreated papayas would most likely be eggs and larvae, and it is unlikely that eggs and larvae could escape. If Trifly eggs and larvae were present in the shipment, and if they reached maturity and escaped, it is unlikely that they could establish a reproducing population in the areas in which movement of untreated papayas would be authorized under this section because of either the relatively cool climate or the lack of suitable host material in those areas. Further, untreated papayas would be treated on [[Page 38110]] the mainland before being distributed, minimizing the possibility that any eggs and larvae could reach maturity and escape. Carambolas from Hawaii Carambola (Averrhoa carambola) fruit is a recorded host of Trifly. Based on ARS research and recommendations, 1 we are also proposing to amend Sec. 318.13-4f to allow the interstate movement of carambolas from Hawaii with irradiation treatment. The same provisions proposed for papaya, including irradiation treatment dosage, would apply. --------------------------------------------------------------------------- \1\ Information on this and other ARS research may be obtained by writing to Dr. Ken Vick, USDA, ARS, NPS, BARC-West, Building 005, Beltsville, MD 20705. --------------------------------------------------------------------------- Litchis from Hawaii Litchi (Litchi chinensis) fruit is a recorded host of the Mediterranean fruit fly and Oriental fruit fly, among other pests, but litchi is not a recorded host for melon fly. Based on ARS research and recommendations, we are proposing to further amend Sec. 318.13-4f to allow the interstate movement of litchis from Hawaii with irradiation treatment. The same provisions proposed for papaya, including irradiation treatment dosage, would apply. We have determined, however, that irradiation treatment may not affect other pests that may be carried by litchi. One pest, the litchi rust mite (Eriphyes litchi), would not be easily detected by an inspector. Therefore, the entry of litchi from Hawaii into Florida, where most mainland litchi is grown, would be prohibited as a precaution against the possible introduction of litchi rust mite. Accordingly, the cartons in which the litchi are packed would have to be stamped ``Not for importation into or distribution in FL.'' Other pests that may be carried by the litchi, including the litchi fruit moth (Cryptophlebia spp.), could be easily detected by inspection. We propose to require that the litchis be inspected by an inspector and found free of plant pests prior to interstate movement under a limited permit. Allowing the interstate movement of litchis from Hawaii under the conditions described above would facilitate trade while continuing to provide protection against the spread of plant pests into other parts of the United States. As an alternative to the irradiation treatment for litchi from Hawaii, we are proposing to allow the interstate movement of litchis from Hawaii if the litchis are inspected and found free of the litchi fruit moth (Cryptophlebia spp.) and other plant pests by an inspector and then treated with hot water for the Mediterranean fruit fly and Oriental fruit fly under the supervision of an inspector before the litchis' interstate movement. However, because the litchi rust mite cannot be effectively detected by inspection and would not be eliminated by hot water treatment, we are proposing that the litchi be prohibited movement into Florida. Accordingly, the cartons in which the litchi are packed would have to be stamped ``Not for importation into or distribution in FL.'' The provisions described above for litchi from Hawaii would be added to the regulations as a new Sec. 318.13-4e. Research conducted by ARS indicates that the following hot water treatment of litchis would provide probit 9 quarantine security (no more than 3 individuals surviving from an estimated treatment population of 100,000 target) against any potential infestations of Mediterranean fruit fly or Oriental fruit fly: ------------------------------------------------------------------------ Water temperature Time ------------------------------------------------------------------------ 49 deg.C (120.2 deg.F) or above...... 20 minutes. ------------------------------------------------------------------------ Treatment would begin when the water temperature is 49 deg.C (120.2 deg.F) or above in all locations throughout the tank; the tank must be designed to allow sufficient water circulation and heating to maintain treatment temperatures during the 20 minute treatment cycle. Hot water treatment tanks with upper temperature limits of 49.5 deg.C (121.1 deg.F) would be recommended, because temperatures exceeding 49.5 deg.C (121.1 deg.F) could cause phytotoxicity damage due to overheating. Hydrocooling for 20 minutes at temperatures of 24 deg.C (75.2 deg.F) # 4 deg.C (7.2 deg.F) would also be recommended to prevent injury to the fruit from the hot water treatment. This treatment schedule for litchis from Hawaii would be added to the Plant Protection and Quarantine (PPQ) Treatment Manual, which is incorporated into the regulations by reference at 7 CFR 300.1. Definition of Inspector We are proposing to amend the definition of inspector in Sec. 318.13-1 to enable a greater number of qualified people to perform inspections on, issue limited permits for, and certify fruits and vegetables moving interstate from Hawaii. We propose that the new definition define an inspector as ``An employee of Plant Protection and Quarantine, or a State plant regulatory official designated by the Administrator to inspect and certify to shippers and other interested parties, as to the condition of the products inspected. To be eligible for designation, a State plant regulatory official must have a bachelor's degree in the biological sciences, a minimum of 2 years' experience in State plant regulatory activities, and a minimum of 2 years' experience in recognizing and identifying plant pests known to occur within Hawaii. Six years' experience in State plant regulatory activities may be substituted for the degree requirement.'' We believe that this proposed definition, which is based in part on the definition for inspector found in 7 CFR 353, ``Phytosanitary Export Certification,'' would allow greater State participation in the inspection process while continuing to provide protection against the spread of injurious plant pests from Hawaii to other parts of the United States. Miscellaneous We are proposing to amend Sec. 318.13-4f so that it permits irradiation treatment for certain fruits or vegetables, not exclusively for papayas. Although papayas, carambolas, and litchis would be the only commodities listed in Sec. 318.13-4f as being approved for this treatment, we expect that additional fruits and vegetables from Hawaii may be approved for irradiation treatment and added to this section through rulemaking in the future. We are also proposing to amend Sec. 318.13-4f(c) to update the address for requests for approval and inspection of irradiation facilies. This proposed rule would facilitate the interstate movement of papayas, carambolas, and litchis from Hawaii while continuing to provide protection against the spread of injurious plant pests from Hawaii to other parts of the United States. Executive Order 12866 and Regulatory Flexibility Act This proposed rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review process required by Executive Order 12866. In accordance with 5 U.S.C. 603, we have performed an Initial Regulatory Flexibility Analysis, which is set out below, regarding the impact of this proposed rule on small entities. However, we do not currently have all the data necessary for a comprehensive analysis of the effects of this rule on small entities. Therefore, we are inviting comments concerning potential effects. In particular, we are interested in determining the number and kind of [[Page 38111]] small entities that may incur benefits or costs from implementation of this proposed rule. In accordance with 7 U.S.C. 162, the Secretary of Agriculture is authorized to promulgate regulations governing the interstate movement of plants and plant products from a State or territory of the United States to prevent the spread of a dangerous plant disease or insect infestation new to or not widely prevalent or distributed within or throughout the United States. This proposed rule would increase the irradiation treatment dose required for papayas from Hawaii and allow irradiation treatment of carambolas and litchis from Hawaii. The proposed rule would also allow papayas, carambolas, and litchis from Hawaii to undergo irradiation treatment in non-fruit fly supporting areas of the mainland United States. In addition, the proposed rule would allow litchis to be moved interstate from Hawaii if they are inspected and found free of the litchi fruit moth and other plant pests and then undergo hot water treatment for Medfly and Oriental fruit fly. Finally, the proposed rule would amend the requirements for irradiation procedures and facilities and the handling of treated and untreated fruits and vegetables. Economic impacts associated with this rulemaking would largely be the result of untreated papayas, carambolas, or litchis being allowed to move to the mainland United States for irradiation treatment. Papayas Papayas are produced commercially on about 340 farms in Hawaii. Nearly 65 percent of those farms are owned by individuals whose major occupation is not farming, while the balance are operated by individuals whose major occupation is farming. Papaya farms with average annual revenues of less than $500,000 are considered small. All papaya farms in Hawaii are therefore considered small. In 1994, Hawaii produced 62 million pounds of papaya (valued at $15 million). Fresh papaya comprised 56.2 million pounds of this total. During that year, Hawaii shipped about 37.8 million pounds of papaya. Shipment of fresh papaya to the mainland totaled about 19.4 million pounds, and the remainder was exported to other countries. Of the approximately 19.4 million pounds of fresh papayas shipped from Hawaii to the mainland in 1994, most went to the West Coast. Seventy five percent of them were sold directly to retailers, and the rest were sold to wholesalers. The United States imported about 41.2 million pounds of fresh papaya (valued at $10.9 million) in 1994. Most of the imported papayas came from Mexico (80 percent), Belize (9.6 percent), Jamaica (6.3 percent), and the Dominican Republic (1.9 percent). The United States exported 18.4 million pounds of fresh papayas (valued at $15.4 million) in 1994. The major importers were Japan (66.8 percent) and Canada (27.1 percent). Almost all United States exports of papayas go out of Hawaii, while all imports come into the mainland United States. There are five firms currently operating nine papaya treatment facilities in the State of Hawaii. Four firms use the vapor-heat treatment method and one uses the dry heat (or high-temperature forced air) method. The total capacity of these treatment chambers is 85,000 pounds per run. Both heat treatment methods have the potential to damage the papayas. They require the center of each papaya fruit to reach about 47 deg.C (about 117 deg.F), a temperature sufficient to kill fruit fly eggs and larvae. Because of variation in fruit size and ripeness, the papayas may not be uniformly heated. This may result in the fruit becoming lumpy and losing flavor. For both methods, careful control of the uniformity of fruit size and ripeness is necessary for effective treatment. In addition, both methods require between 4 and 6 hours of treatment. Efforts to speed up the process result in fruit which is either scalded externally or hardened on the inside. The cost of treatment for both methods ranges from 9 to 23 cents per pound. Although the regulations currently allow papayas to be treated by irradiation in Hawaii, there are no irradiation facilities in that State. Allowing irradiation to be performed on the mainland appears to be an attractive option. The subsequent diversion of untreated papayas from Hawaii to the mainland would likely result in loss of business to the existing vapor heat and dry heat facilities. This could result in lay-offs and possibly the shut-down of some of these facilities. However, if papaya producers respond by producing more papayas, continuing traditional treatment for some and shipping others for irradiation, this would not necessarily occur. Carambolas The United States produced about 6 million pounds of carambola in 1994, with a total value of approximately $4 million to $4.5 million. In the United States, carambola is grown on about 100 farms. All of these farms have a market value of less than $500,000 and are thus considered to be small businesses according to the Small Business Administration's size standards. In 1994, Hawaii produced only about 50,700 pounds of carambola, valued at approximately $38,000, on 35 farms. The provisions proposed in this rule concerning irradiation treatment of carambola fruits by the mainland facilities are expected to stimulate growth of the carambola industry in Hawaii and provide greater access to the larger mainland market. No economic impact on mainland carambola growers is anticipated, since the total Hawaii production of carambola is less than one percent of the mainland production. Therefore, even in the unlikely event that Hawaii could ship 100 percent of its production to the mainland, supply would only increase by less than one percent. However, mainland consumers would likely benefit from increased seasonal and regional availability, as well as from the increased variety of fresh carambola. Additionally, carambola growers in Hawaii would benefit from the opportunity to sell their product in a larger and more diverse market. This proposed rule would enable carambola from Hawaii to be irradiated at an existing irradiation facility on the mainland and is not expected to impose additional costs on carambola producers in Hawaii. We expect that carambola producers in Hawaii would benefit from the proposed irradiation treatment because this treatment could deliver better product quality, extended shelf life of the fruit, and cost effective treatment of the fruit. However, the overall impact of the carambola provisions of the proposed rule is expected to be insignificant. Litchis Litchis are produced commercially on 257 farms in Hawaii. In 1993, the United States produced about 770,000 pounds of litchi. Of that total, approximately 85,000 pounds was produced in Hawaii. Litchi farms with average annual revenues of less than $500,000 are considered small. All litchi farms in Hawaii are considered small. The litchi industry in Hawaii has been constrained by the lack of an approved treatment for fruit flies since the cancellation of ethylene dibromide in 1994. Approving irradiation treatment of litchis on the mainland would be expected to stimulate growth of the industry and provide access to the larger mainland market. No information is available on the effect of approving inspection and hot water treatment as an alternative method for moving litchis interstate. [[Page 38112]] The United States is a net importer of fresh litchi, with a total import of about 165,000 pounds in 1994. In 1994, nearly 70 percent of imported litchi came from Mexico; the remainder came from Israel. The total supply of litchi on the mainland is about 850,000 pounds. Wholesale prices of litchi range between $1.00 per pound and $4.50 per pound. The economic impact on mainland litchi growers and prices on the mainland will not be significant. Even in the unlikely event that Hawaii shipped 25 percent of its production to the mainland, supply would increase by only about 2.3 percent. However, mainland consumers would benefit from increased seasonal and regional availability, an increased variety of fresh litchi, and stable prices. Additionally, litchi growers in Hawaii would benefit from the increased opportunity to sell their product in a larger and more diverse market. According to recent research conducted by the ARS, irradiation appears to be an effective treatment option that does not require control of either fruit size or ripeness. Irradiation typically requires only 40 minutes for treatment. The irradiation method may be more cost effective depending on volume treated, because it costs only about 5 to 12 cents per pound. The proposed rule is expected to benefit producers, since irradiation appears to offer a number of advantages over current treatment options, including greater flexibility of fruit size and ripeness, reduction in treatment time, improved effectiveness against pest infestation, better product quality, extended shelf life, and improved cost effectiveness. Consumers also could benefit from a better quality product. The overall impact upon supply, price, and competitiveness is expected to be insignificant. This proposed rule contains paperwork requirements. Under this proposed rule, a limited permit would be required for untreated papayas, carambolas, and litchis moved interstate from Hawaii for irradiation. The alternative to this proposed rule would be to take no action. We do not consider taking no action a reasonable alternative. Papayas, carambolas, and litchis are not currently moved interstate from Hawaii because of a lack of suitable treatment options. This proposed rule would facilitate the interstate movement of papayas, carambolas, and litchis from Hawaii while continuing to provide protection against the spread of injurious plant pests from Hawaii to other parts of the United States. Executive Order 12372 This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 7 CFR part 3015, subpart V.) Executive Order 12778 This proposed rule has been reviewed under Executive Order 12778, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required 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. 95-069-1. Please send a copy of your comments to: (1) Docket No. 95-069-1, Regulatory Analysis and Development, PPD, APHIS, suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OIRM, USDA, room 404-W, 14th Street and Independence Avenue SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule. We are proposing to increase the irradiation treatment dose required for papayas intended for interstate movement from Hawaii and to allow carambolas and litchis to be moved interstate from Hawaii with irradiation treatment. We are also proposing to allow papayas, carambolas, and litchis from Hawaii to undergo irradiation treatment either in Hawaii or in non-fruit fly supporting areas of the mainland United States. We are also proposing to allow litchis to be moved interstate from Hawaii if they are inspected and found free of the litchi fruit moth and undergo hot water treatment for fruit flies. In addition, we are proposing several amendments to the requirements for irradiation procedures and facilities and the handling of treated and untreated fruits and vegetables. These proposals would facilitate the interstate movement of papayas, carambolas, and litchis from Hawaii while continuing to provide protection against the spread of Trifly from Hawaii to other parts of the United States. The implementation of these proposed regulatory actions would require us to engage in certain information collection activities that would necessitate the use of several forms, including limited permits and container markings. We are seeking OMB approval to use the following forms: PPQ Form 530 (Limited Permit): The proposed rule would require that untreated papayas moved interstate from Hawaii for treatment at an irradiation facility on the United States mainland be accompanied by a limited permit. The permit would be issued by an inspector after the inspector examines the shipment and determines that it has been prepared in compliance with our regulations. Container Marking and Identity: The proposed rule would require that pallet loads of irradiation-treated papayas be marked (by irradiation facility personnel or by the shipper) with treatment lot numbers, packing and treatment facility identification and locations, and dates of packing and treatment. This information would allow an inspector to identify the treatment lots and trace them back to the packing and treatment facilities. We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. We need this outside input to help us: (1) Evaluate whether the 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 [[Page 38113]] is estimated to average 15 minutes per response. Respondents: Importers, exporters, and shippers. Estimated number of respondents: 352. Estimated number of responses per respondent: 1. Estimated total annual burden on respondents: 88 hours. Copies of this information collection can be obtained from: Clearance Officer, OIRM, USDA, Room 404-W, 14th Street and Independence Ave., SW, Washington, DC 20250. List of Subjects 7 CFR Part 300 Incorporation by reference, Plant diseases and pests, Quarantine. 7 CFR Part 318 Cotton, Cottonseeds, Fruits, Guam, Hawaii, Plant diseases and pests, Puerto Rico, Quarantine, Transportation, Vegetables, Virgin Islands. Accordingly, 7 CFR parts 300 and 318 would be amended as follows: PART 300--INCORPORATION BY REFERENCE 1. The authority citation would continue to read as follows: Authority: 7 U.S.C. 150ee, 154, 161, 162, and 167; 7 CFR 2.22, 2.80, and 371.2(c). 2. In Sec. 300.1, paragraph (a), the introductory text would be revised to read as follows: Sec. 300.1 Materials Incorporated by reference; availability. (a) Plant Protection and Quarantine Treatment Manual. The Plant Protection and Quarantine Treatment Manual, which was reprinted on November 30, 1992, and includes all revisions through __________, has been approved for incorporation by reference in 7 CFR chapter III by the Director of the Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. * * * * * PART 318--HAWAIIAN AND TERRITORIAL QUARANTINE NOTICES 3. The authority citation for part 318 would continue to read as follows: Authority: 7 U.S.C. 150bb, 150dd, 150ee, 150ff, 161, 162, 164a, and 167; 7 CFR 2.22, 2.80, and 371.2(c). 4. In Sec. 318.13-1, the definition for Inspector would be revised to read as follows: Sec. 318.13-1 Definitions. * * * * * Inspector. An employee of Plant Protection and Quarantine, or a State plant regulatory official designated by the Administrator to inspect and certify to shippers and other interested parties, as to the condition of the products inspected. To be eligible for designation, a State plant regulatory official must have a bachelor's degree in the biological sciences, a minimum of 2 years' experience in State plant regulatory activities, and a minimum of 2 years' experience in recognizing and identifying plant pests known to occur within Hawaii. Six years' experience in State plant regulatory activities may be substituted for the degree requirement. * * * * * 5. In Sec. 318.13-3, a new paragraph (b)(3) would be added to read as follows: Sec. 318.13-3 Conditions of movement. * * * * * (b) * * * (3) Untreated fruits and vegetables from Hawaii may be moved interstate for irradiation treatment on the mainland United States if the provisions of Sec. 318.13-4f are met and if the fruits and vegetables are accompanied by a limited permit issued by an inspector in accordance with Sec. 318.13-4(c). The limited permit will be issued only if the inspector examines the shipment and determines that the shipment has been prepared in compliance with the provisions of this subpart. * * * * * 6. A new Sec. 318.13-4e would be added to read as follows: Sec. 318.13-4e Administrative instructions governing the movement of litchis from Hawaii to other States. (a) Litchis may be moved interstate from Hawaii only in accordance with this section or Sec. 318.13-4f and all other applicable provisions of this part. (b) To be eligible for interstate movement under this section, litchi must be inspected and found free of the litchi fruit moth (Cryptophlebia spp.) and other plant pests by an inspector and then treated for fruit flies under the supervision of an inspector with a treatment authorized by the Administrator. (c) Treatments authorized by the Administrator are listed in the Plant Protection and Quarantine Treatment Manual, which is incorporated by reference at Sec. 300.1 of this chapter. (d) Litchi from Hawaii may not be moved interstate into Florida. All cartons in which litchi from Hawaii are packed must be stamped ``Not for importation into or distribution in FL.'' 7. Section 318.13-4f would be amended as follows: a. By revising the heading to read as set forth below. b. By revising paragraph (a) to read as set forth below. c. By revising the heading and the introductory text to paragraph (b) to read as set forth below. d. By revising paragraph (b)(1) to read as set forth below. e. In paragraph (b)(2)(i), by removing the words ``15 kilorads (150 Gray) to the papayas'' and adding ``250 Gray (25 krad)'' in its place. f. In paragraph (b)(2)(ii), by removing the word ``fruit'' each time it appears and adding ``fruits and vegetables'' in its place. g. In paragraph (b)(2)(ii), at the end of the paragraph, by adding a new sentence to read as set forth below. h. By adding a new paragraph (b)(2)(iv) to read as set forth below. i. In paragraph (b)(4), in the first sentence, by removing the words ``Papayas are'' and adding, in their place, the words ``Fruits and vegetables that are treated in Hawaii must be''. j. By redesignating the introductory text of paragraph (b)(4) as paragraph (b)(4)(i), and by adding new paragraphs (b)(4)(ii), (b)(4)(iii) and (iv) to read as set forth below. k. By revising paragraphs (b)(5) and (b)(6) to read as set forth below. l. By removing paragraphs (b)(7), (b)(8), and (b)(9). m. By adding a new paragraph (b)(7) to read as set forth below. n. By redesignating paragraph (b)(10) as paragraph (b)(8). o. In newly designated paragraph (b)(8), the beginning of the second sentence, by removing the words ``A papaya'' and adding the word ``An'' in their place. p. By revising paragraph (c) to read as set forth below. q. In paragraph (d)(1), by removing the word ``papaya'' each time it appears. r. In paragraph (d)(2), by removing the words ``a papaya'' in the first sentence and adding the word ``an'' in its place, and by removing the word ``papaya'' each time it appears. s. In paragraph (e), by removing the word ``papayas'' and adding ``the fruits and vegetables authorized for treatment under this section'' in its place. Sec. 318.13-4f Administrative instructions prescribing methods for irradiation treatment of certain fruits and vegetables from Hawaii. (a) Approved irradiation treatment. Irradiation, carried out in accordance with the provisions of this section, is approved as a treatment for the [[Page 38114]] following fruits and vegetables: carambola, litchi, and papaya. (b) Conditions of movement. Fruits and vegetables from Hawaii may be authorized for movement in accordance with this section only if the following conditions are met: (1) Location. The irradiation treatment must be carried out at an approved facility in Hawaii or on the mainland United States. Fruits and vegetables authorized under this section for treatment on the mainland may be treated in any State on the mainland United States except Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Tennessee, Texas, or Virginia. Prior to treatment, the fruits and vegetables may not move into or through Alabama, Arizona, California, Florida, Georgia, Kentucky, Louisiana, Mississippi, Nevada, New Mexico, North Carolina, South Carolina, Tennessee, Texas, or Virginia, except that movement would be allowed through Dallas/Fort Worth, Texas, as an authorized stop for air cargo, or as a transloading location for shipments that arrive by air but that are subsequently transloaded into trucks for overland movement from Dallas/Fort Worth into an authorized State by the shortest route. * * * * * (2) * * * (ii) * * * Untreated fruits and vegetables shipped to the mainland United States from Hawaii in accordance with this section may not be packaged for shipment in a carton with treated fruits and vegetables. * * * * * (iv) Be certified by Plant Protection and Quarantine for initial use and annually for subsequent use. Recertification is required in the event that an increase or decrease in radioisotope or a major modification to equipment that affects the delivered dose. Recertification may be required in cases where a significant variance in dose delivery is indicated. * * * * * (4) * * * (ii) The pallet-load of cartons must be wrapped before it leaves the irradiation facility in one of the following ways: (A) With polyethylene sheet wrap; (B) With net wrapping; or (C) With strapping so that each carton on an outside row of the pallet load is constrained by a metal or plastic strap. (iii) Packaging must be labeled with treatment lot numbers, packing and treatment facility identification and location, and dates of packing and treatment. (iv) Litchi from Hawaii may not be moved interstate into Florida. All cartons in which litchi from Hawaii are packed must be stamped ``Not for importation into or distribution in FL.'' (5) Dosage. The fruits and vegetables must receive a minimum absorbed ionizing radiation dose of 250 Gray (25 krad).5 --------------------------------------------------------------------------- \5\ See footnote 2. --------------------------------------------------------------------------- (6) Dosimetry systems. (i) Dosimetry must demonstrate that the absorbed dose, including areas of minimum and maximum dose, is mapped, controlled, and recorded. (ii) Absorbed dose must be measured using a dose indicator that can accurately measure an absorbed dose of 250 Gray (25 krad). (iii) The number and placement of dosimeters used must be in accordance with American Society for Testing and Materials (ASTM) standards.6 --------------------------------------------------------------------------- \6\ Designation E, ``Standard Guide for Selection and Calibration of Dosimetry Systems for Radiation Processing,'' American Society for Testing and Materials, Annual Book of ASTM Standards. --------------------------------------------------------------------------- (7)(i) Certification on basis of treatment. A certificate shall be issued by an inspector for the movement of fruits and vegetables from Hawaii that have been treated and handled in accordance with this section. (ii) Limited permit. A limited permit shall be issued by an inspector for the interstate movement of untreated fruits and vegetables from Hawaii for treatment on the mainland United States in accordance with this section. * * * * * (c) Request for approval and inspection of facility. Persons requesting approval of an irradiation treatment facility and treatment protocol must submit the request for approval in writing to the Animal and Plant Health Inspection Service, Plant Protection and Quarantine, Oxford Plant Protection Center, 901 Hillsboro St., Oxford, NC 27565. Before the Administrator determines whether an irradiation facility is eligible for approval, an inspector will make a personal inspection of the facility to determine whether it complies with the standards of paragraph (b)(2) of this section. * * * * * Done in Washington, DC, this 16th day of July 1996. A. Strating, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. 96-18461 Filed 7-22-96; 8:45 am] BILLING CODE 3410-34-P