Animal and Plant Health Inspection Service, USDA.
We are amending the regulations to allow bell peppers, eggplant, mangoes, pineapple (other than smooth Cayenne), Italian squash, and tomatoes to be moved interstate from Hawaii if the fruits and vegetables undergo irradiation treatment at an approved facility. Treatment may be conducted either in Hawaii or in areas of the mainland United States where tropical fruit flies are not likely to become established. The fruits and vegetables will also have to meet certain additional requirements, including packaging requirements. This action relieves restrictions on the movement of these fruits and vegetables from Hawaii while continuing to provide protection against the spread of plant pests from Hawaii to other parts of the United States.
February 5, 2003.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mr. Hesham A. Abuelnaga, Import Specialist, Phytosanitary Issues Management Team, PPQ, APHIS, 4700 River Road Unit 140, Riverdale, MD 20737-1236; (301) 734-5334.End Further Info End Preamble Start Supplemental Information
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 from Hawaii. Regulation is necessary to prevent the spread of dangerous plant diseases and pests that occur in Hawaii.
The regulations in § 318.13-4f allow abiu, atemoya, carambola, litchi, longan, papaya, rambutan, and sapodilla to be moved interstate from Hawaii if, among other things, the fruits and vegetables undergo irradiation treatment in accordance with that section.
On May 22, 2002, we published in the Federal Register (67 FR 35932-35936, Docket No. 00-052-1) a proposal to amend the regulations to allow bell peppers, eggplant, mangoes, pineapple (other than smooth Cayenne), Italian squash, and tomatoes to be moved interstate from Hawaii if treated with irradiation in accordance with the requirements in § 318.13-4f. The proposal was prompted by research by the Department's Agricultural Research Service (ARS) that showed that this irradiation treatment could eliminate infestations of fruit flies and other pests in those commodities. In that same document, we also proposed to amend the irradiation regulations to require cartons of fruits and vegetables that are being moved interstate in accordance with the regulations to be marked with irradiation indicators.
We solicited comments concerning our proposal for 60 days ending July 22, 2002. We received six comments by that date. The comments were from researchers, a manufacturer of irradiation equipment, and representatives of a State government. The commenters generally supported the proposal. However, four commenters expressed concern over the proposed requirement for the use of Start Printed Page 5797irradiation indicators. Also, another commenter raised concerns about including mangoes on the list of fruits approved for movement from Hawaii if treated with irradiation. These comments are discussed below by topic.
We proposed to amend the irradiation provisions in § 318.13-4f to require cartons of fruits and vegetables being moved interstate in accordance with the regulations to be marked with irradiation indicators. Specifically, we had proposed to add a new § 318.13-4f(b)(7) to read as follows: “Indicators. Each carton of fruits and vegetables must bear an indicator device, securely attached prior to irradiation, that changes color or provides another clear visual change when it is exposed to radiation in the dose range required by this section for the pests for which the articles are being treated.” Four commenters opposed this proposed requirement for numerous technical, operational, and cost-benefit reasons.
One commenter referred to several studies that deal with the limitations of available radiation-sensitive indicators. Specifically, the commenter stated that dose fluctuations resulting from density variations caused by the arrangement, size, and weight of individual fruit within the subunits of a pallet would make irradiation indicators impractical and unreliable.
Another commenter stated that the indicators that are currently available have not undergone adequate testing and standard development, and, therefore, their reliability is questionable. In addition, the commenter suggested that the added labor costs for the additional handling must be taken into account, offsetting the low cost of the production of the indicators themselves.
One comment, which was reviewed and submitted by several researchers, offered detailed discussion of several issues related to the use of irradiation indicators. The comment referred to American Society for Testing and Materials (ASTM) Standard E 1539-98, “Standard Guide for the Use of Radiation-Sensitive Indicators.” Section 7.3 of that document states: “Some irradiation or storage conditions may result in false positive or negative observations. For these reasons, indicators should not be used as a criterion for product release. Also, external environmental influences may make the interpretation of the indicators meaningless outside the irradiation facility unless appropriate controls are used.” The commenter indicated that, for several technical reasons, irradiation indicators can only be used effectively to show that products have been exposed to “some” radiation, and not to show the exact dose of radiation that a product has received.
We have carefully analyzed all the data and opinions submitted recommending against the proposed indicator requirement and have decided to omit that requirement from this final rule. While we believe that an indicator could be employed as a useful “cross check” when Animal and Plant Health Inspection Service (APHIS) inspectors are correlating the required interstate movement certificates with the cartons referred to in those documents to offer additional protection against the introduction of plant pests into the mainland United States from Hawaii, apparently there is no such indicator that is: (1) Currently available at low cost; (2) validated to be sensitive and reliable in the appropriate dose ranges; and (3) validated to be resistant to false positives and false negatives caused by environmental effects. Therefore, we have omitted proposed § 318.13-4f(b)(7) from this final rule.
One commenter noted that there are only two studies to date that examine the relationship between radiation dose and fertility in the adult mango seed weevil (Sternochetus mangiferae (Fabricus), formerly known as Cryptorhynchus mangiferae). The commenter stated that these studies do not provide adequate support for the proposed dose of 100 Gy (10 krad), which was recommended by ARS research findings as a sufficient quarantine treatment for mango seed weevil. The commenter suggested that, based on the limited amount of research that has been done, Hawaiian mangoes should be subjected to higher doses of radiation than 100 Gy (10 krad). We had proposed a minimum ionizing irradiation dose of 250 Gy (25 krad) for mangoes, which we indicated would be effective in eliminating both fruit flies and the mango seed weevil.
We have carefully analyzed the data and conducted a review of the available literature on this topic and have determined that a higher dose of irradiation for mango seed weevil is appropriate. Based on research by ARS (Follett, 1999) and by the International Consultative Group on Food Irradiation of the Food and Agriculture Organization of the United Nations, we are setting an irradiation dose level of 300 Gy (30 krad) for mango seed weevil in this final rule. We believe that there is enough research and evidence to support this dose level as an effective quarantine treatment for mango seed weevil.
The same commenter also stated that a dose of 250 Gy is excessive for fruit flies. He indicated that “recent research and analyses have demonstrated that studies finding that doses >150 Gy were needed most likely are in error,” but did not identify specific studies or analyses. He asked when APHIS would consider lower doses.
The research supporting this comment may have merit, but such research must be carefully evaluated and verified before we lower doses below the proposed level, which we know is effective. APHIS, in cooperation with ARS and others, will evaluate the lower doses recommended by this commenter. If we determine that lower doses are effective for fruit flies, we will initiate rulemaking in the future to reduce the doses. However, this evaluation process will take time, so in this final rule we are utilizing the dose of 250 Gy for fruit flies so that irradiation treatments may occur while this evaluation is underway.
The same commenter also stated that there should be a range of time given for irradiation treatment the way that a time range is given for vapor heat treatment in the comparison table (see Table 3) in the proposed rule. The commenter also asked if the comparison table compared values for the same amount of fruit in both treatments.
The comparison table was offered in the proposed rule's economic analysis to illustrate the relative cost and time-saving benefits of irradiation treatments when compared to the presently available vapor heat treatment, not to set specific values for the two treatments. Although the same amount of fruit was used in both treatments, it was not possible to give a time range for irradiation treatment comparable to the time range given for the heat vapor treatment because of the number of Start Printed Page 5798variables involved in the irradiation process. The irradiation exposure times that are necessary to ensure that the specified dose has been delivered and absorbed vary widely by commodity and by equipment, which is available from several different manufacturers of irradiation equipment. The Plant Protection and Quarantine Treatment Manual, which is incorporated by reference in 7 CFR § 300.1, states that irradiation facilities must use ASTM Standard E 1261, “Guide for Selection and Calibration of Dosimetry Systems for Radiation” (or an equivalent international standard) as a guide for selection and calibration of an appropriate dosimetry system that matches the dosimeter requirements specific to their needs, and that irradiation exposure times must be evaluated for each commodity. The necessary dosage levels vary from 150 Gy (15 krad) to 300 Gy (30 krad) based on commodity, and each piece of equipment varies in the amount of time it takes to ensure that these dosage levels have been delivered and absorbed. Any time range given would not be able to take into account all of these possibilities and would therefore be inaccurate. We are not making any changes to the rule based on this comment.
The regulations in § 318.13-4f currently specify 250 Gy (25 krad) as the minimum absorbed dose for all treated commodities. Because, as noted above, we are setting the minimum absorbed dose for mangoes at 300 Gy (30 krad), we have amended several paragraphs in § 318.13-4f so that they refer to “the specified dose” rather than to 250 Gy (25 krad).
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.
This is a substantive rule that relieves restrictions and, pursuant to the provisions of 5 U.S.C. 553, may be made effective less than 30 days after publication in the Federal Register.
This rule relieves restrictions on the interstate movement of bell peppers, eggplant, mangoes, pineapple (other than smooth Cayenne), Italian squash, and tomatoes from Hawaii to the mainland United States. Making this rule effective immediately will allow interested producers, as well as manufacturers of the irradiation equipment that will be used to treat these articles, to benefit from trade as soon as possible. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective upon publication in the Federal Register.
Executive Order 12866 and Regulatory Flexibility Act
This rule has been reviewed under Executive Order 12866. The 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.
We are amending the Hawaiian Fruits and Vegetables regulations to allow bell peppers, eggplant, mangoes, pineapple (other than smooth Cayenne), Italian squash, and tomatoes to be moved interstate from Hawaii if they are treated with irradiation in accordance with the regulations in § 318.13-4f. Irradiation at certain dosages eliminates infestations of pests in fruits and vegetables. Irradiation also eliminates bacterial or fungal growth that can otherwise cause accelerated spoilage and result in illness. Bacterial contamination can come from soil, insects, bird or rodent droppings, or the water used in processing.
Effects on Producers and Shippers of Fruits and Vegetables
Since 1995, the amount of land used for commercial production of mangoes in Hawaii has nearly tripled, and more than 7,500 new mango trees have been planted. However, producers in Hawaii have not been able to ship mangoes to the mainland United States due to the presence of the mango seed weevil in Hawaii (the mango seed weevil is not present in the mainland United States). The irradiation treatment in this final rule provides an effective quarantine treatment for the mango seed weevil that will protect against the introduction and dissemination of this pest into the mainland United States from Hawaii. This final rule opens the mainland U.S. mango market to Hawaiian mangoes.
U.S. production of mangoes has primarily been in southern Florida, with a smaller quantity grown in Hawaii and a negligible amount produced in California. According to the 1997 Census of Agriculture, there were 218 mango farms in Florida, 171 in Hawaii, and 2 in California. The total domestic harvest that year was about 2,829 metric tons, of which about 97 percent was produced in Florida and about 3 percent (approximately 85 metric tons) produced in Hawaii. According to National Agricultural Statistics Service data, Hawaii produced approximately 72 metric tons of mangoes in 1999. It is unlikely that this final rule will result in a significant amount of mangoes being moved from Hawaii to the mainland United States because it is expected that nearly all mangoes produced in Hawaii will continue to be consumed within the State. Further, given that the United States imported 219,000 metric tons of mangoes between September 1998 and August 1999, any movements of Hawaii-grown mangoes to the mainland United States will be insignificant in contrast to the volume of annual imports.
Bell peppers, eggplant, pineapple (other than smooth Cayenne), Italian squash, and tomatoes are currently allowed to move interstate from Hawaii if they are first treated for Mediterranean fruit fly, oriental fruit fly, and melon fly with vapor heat in accordance with § 318.13-4b. Tomatoes may also be moved interstate from Hawaii if they are treated with methyl bromide in accordance with § 318.13-4c. This rule provides for an alternative means of treating bell peppers, eggplant, pineapple (other than smooth Cayenne), Italian squash, and tomatoes from Hawaii for fruit flies and other pests.
Since 1995, Hawaii's production of bell peppers, eggplant, Italian squash, and tomatoes has increased in value and volume (see tables 1 and 2). Hawaii's production of pineapples (other than smooth Cayenne) has decreased by 4 percent, but its value has increased by 6 percent.Start Printed Page 5799
|Volume (fresh weight in lbs.)||2,400,000||2,600,000||2,000,000||3,000,000|
|Volume (fresh weight in lbs.)||1,200,000||1,300,000||1,500,000||1,300,000|
|Pineapples (other than smooth Cayenne)|
|Volume (fresh weight in lbs.)||760,594,590||765,003,834||714,297,528||731,934,504|
|Volume (fresh weight in lbs.)||620,000||700,000||1,400,000||1,500,000|
|Volume (fresh weight in lbs.)||6,000,000||7,000,000||10,200,000||10,200,000|
|Volume (percent)||Value (percent)|
|Pineapples (other than smooth Cayenne)||+25||+8|
According to the Hawaii Agricultural Census, there were 27 farms growing pineapples for commercial sale in 1997. Twenty-two (or 82 percent) of those farms harvested between 1 and 14 acres of pineapple. During the same year, 74 farms produced tomatoes for commercial sale (a total of 388 acres harvested). There are no official data with respect to the number of farms in Hawaii producing bell peppers, eggplant, and Italian squash during the same year. However, considering that in 1997 there were 657 farms in Hawaii that harvested fruits and vegetables for sale (90 percent of which had less than 14 acres of crops planted), we believe that the majority of farms producing bell peppers, eggplant, and Italian squash for sale were small according to Small Business Administration (SBA) criteria. It is also likely that the majority of firms shipping bell peppers, eggplant, and Italian squash interstate from Hawaii are small according to SBA criteria.
Regardless of their size, Hawaii's fruit and vegetable producers and shippers who move fruits and vegetables interstate from Hawaii will benefit from the availability of an additional treatment alternative, especially since this treatment is less time-consuming than the presently available vapor heat treatment (see Table 3).
|Cost||$0.22 to $0.33/kg (treatment cost)||$0.20 to $0.50/kg|
|Treatment Time||40 minutes||1.5 to 7 hours|
Effects on Treatment Facilities
The irradiation treatments for bell peppers, eggplants, mangoes, pineapples (other than smooth Cayenne), Italian squash, and tomatoes will take place mostly at a new facility that was recently built in Hawaii. However, it is possible that some of these fruits and vegetables could be shipped to the mainland United States and treated with irradiation at facilities in Illinois or New Jersey. At present, various other tropical fruits, such as papaya, litchi, rambutan, carambola, and atemoya are shipped from Hawaii to a facility in Illinois for cobalt irradiation treatment.
On August 1, 2000, a new x-ray irradiation facility in Hawaii began treating papayas, which, after their x-ray treatment, are commercially shipped to the mainland United States. This facility treats between 500 to 1,000 boxes of papayas per day, 4 days per week.
This facility will be the primary irradiation facility to treat Hawaii-grown Start Printed Page 5800bell peppers, eggplants, mangoes, pineapples (other than smooth Cayenne), Italian squash, and tomatoes before they are moved interstate. However, if there is not enough capacity at the Hawaiian plant for the fruits to be irradiated, the fruits can be sent for treatment to any of the three irradiation treatment facilities on the mainland United States.
According to SBA criteria, the facility in Hawaii mentioned in the previous paragraphs is a small entity (i.e., an entity with annual sales of less than $5 million). Another firm that provides irradiation treatments for fruits and vegetables owns two irradiation facilities in Illinois and one facility in New Jersey. This other firm, which primarily provides irradiation treatment to sanitize medical devices, is not a small entity according to SBA criteria.
This final rule benefits the Hawaiian treatment facility, and may benefit the mainland facilities if the Hawaiian facility cannot keep up with demand for treatment of fruits and vegetables moving interstate from Hawaii. The final rule could also potentially benefit U.S. mainland consumers by increasing the mainland's supply of those fruits and vegetables that will now be eligible for interstate movement with irradiation treatment.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action will not have a significant economic impact on a substantial number of small entities.
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.)
This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. 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.
Paperwork Reduction Act
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 0579-0198. Government Paperwork Elimination Act Compliance
The Animal and Plant Health Inspection Service is committed to compliance with the Government Paperwork Elimination Act (GPEA), which requires Government agencies in general to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. For information pertinent to GPEA compliance related to this rule, please contact Mrs. Celeste Sickles, APHIS” Information Collection Coordinator, at (301) 734-7477.Start List of Subjects
List of Subjects in 7 CFR Part 318
- Plant diseases and pests
- Puerto Rico
- Virgin Islands
Accordingly, we are amending 7 CFR part 318 as follows:Start Part
PART 318—HAWAIIAN AND TERRITORIAL QUARANTINE NOTICESEnd Part Start Amendment Part
1. The authority citation for part 318 continues to read as follows:End Amendment Part Start Amendment Part
2. Section 318.13-4f is amended as follows:End Amendment Part
a. By revising paragraphs (a), (b)(2)(i), (b)(5), and (b)(6)(ii) to read as set forth below.
b. By adding, at the end of the section, the following: “(Approved by the Office of Management and Budget under control number 0579-0198)”.
(a) Approved irradiation treatment. Irradiation, carried out in accordance with the provisions of this section, is approved as a treatment for the following fruits and vegetables at the specified dose levels:
|Pineapple (other than smooth Cayenne)||250|
(b) * * *
(2) * * *
(i) Be capable of administering the minimum absorbed ionizing radiation doses specified in paragraph (a) of this section to the fruits and vegetables; 
(5) Dosage. The fruits and vegetables must receive the minimum absorbed ionizing radiation dose specified in paragraph (a) of this section.
(6) * * *
(ii) Absorbed dose must be measured using a dosimeter that can accurately measure the absorbed doses specified in paragraph (a) of this section.
Done in Washington, DC this 30th day of January 2003.
Acting Administrator, Animal and Plant Health Inspection Service.
1. Ehlermann, D.A.E. (Federal Research Centre for Nutrition, Karlsruhe (Germany). Inst. of Process Engineering), “Validation of a label dosimeter for food irradiation applications by subjective and objective means,” Appl. Radiat. Isot.; v. 48(9), p. 1197-1201; 1997.
International Atomic Energy Agency, “Standardized methods to verify absorbed dose in irradiated food for insect control,” IAEA, Vienna, 2001, IAEA-TECDOC-1201.
Razem, D. (Ruder Boskovic Inst., Zagreb (Croatia)), “Dosimetric performance of and environmental effects on sterin irradiation indicator labels,” Radiat. Phys. Chem.; v.49(4), p. 491-495.Back to Citation
2. “Irradiation as a Quarantine Treatment of Fresh Fruits and Vegetables,” ICGFI, 1991. This publication also cited two other studies, (Heather and Corcoran, 1990) and (Jessup and Rigney, 1990), that supported an irradiation dose level of 300 Gy (30 krad) for mango seed weevil.Back to Citation
3. The mango seed weevil attacks mango seeds, but rarely the fruit, and may cause slight fruit drop in production areas. The mango seed weevil poses no threat to other crops or flora. It is strictly monophagous.Back to Citation
2. The maximum absorbed ionizing radiation dose and the irradiation of food is regulated by the Food and Drug Administration under 21 CFR part 179.Back to Citation
5. See footnote 2.Back to Citation
[FR Doc. 03-2681 Filed 2-4-03; 8:45 am]
BILLING CODE 3410-34-P