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Rules and Regulations Federal Register Vol. 71, No. 18

Friday, January 27, 2006

This section of the FEDERAL REGISTER an alternative to the currently approved 9, 2005. We received 13 comments by contains regulatory documents having general treatments for those commodities while that date. They were from producers, applicability and legal effect, most of which continuing to provide protection against researchers, representatives of State and are keyed to and codified in the Code of the spread of plant pests from foreign agricultural departments, an Federal Regulations, which is published under into the continental United States. international industry organization, a 50 titles pursuant to 44 U.S.C. 1510. EFFECTIVE DATE: February 27, 2006. public interest organization, and a The Code of Federal Regulations is sold by FOR FURTHER INFORMATION CONTACT: Dr. private citizen. The comments are the Superintendent of Documents. Prices of Inder P.S. Gadh, Senior Risk Manager, discussed below by topic. new books are listed in the first FEDERAL Commodity Import Analysis & Issue Outside the Scope of APHIS’ REGISTER issue of each week. Operations, PPQ, APHIS, 4700 River Authority Road Unit 133, Riverdale, MD 20737– One commenter raised an issue that 1236; (301) 734–8758. DEPARTMENT OF AGRICULTURE concerns a matter under the regulatory SUPPLEMENTARY INFORMATION: authority of the Food and Drug and Plant Health Inspection Background Administration (FDA), not the Animal Service and Plant Health Inspection Service The phytosanitary treatments (APHIS). Specifically, the commenter 7 CFR Parts 301, 305, 318, and 319 regulations contained in 7 CFR part 305 expressed concern that irradiation will set out standards and schedules for [Docket No. 03–077–2] make foods unsafe to eat. The treatments required in 7 CFR parts 301, commenter stated that irradiation 318, and 319 for fruits, vegetables, and Treatments for Fruits and Vegetables produced 2-alkylcyclobutanones, which other articles to prevent the she contended is a dangerous residue AGENCY: Animal and Plant Health introduction or dissemination of plant chemical present in irradiated fruits and Inspection Service, USDA. pests or noxious weeds into or through vegetables. ACTION: Final rule. the United States. Within 7 CFR part The FDA has primary regulatory 305, the irradiation treatments subpart responsibility for ensuring that SUMMARY: We are amending the (§§ 305.31 through 305.34, referred to approved irradiation doses do not regulations by revising the approved below as the regulations) sets out render foods unsafe to eat. FDA doses for irradiation treatment of standards and minimum doses for regulations (21 CFR 179.26) establish a imported fruits and vegetables. This rule irradiation treatment for imported fruits limit of 1.0 kilogray for disinfestation of will establish a new minimum generic and vegetables and for regulated articles pests in fresh fruits and dose of irradiation for most plant pests moved interstate from quarantined areas vegetables. All of the irradiation doses of the class Insecta, establish a new within the United States, along with contained in this rule are significantly minimum generic dose for the fruit fly other requirements for performing less than this approved safe dose limit. family, reduce the minimum dose of irradiation treatments. irradiation for some specific fruit fly On June 10, 2005, we published in the Use of Irradiation to Treat Cut Flowers species, add 10 pests to the list of pests Federal Register (70 FR 33857–33873, and Foliage for which irradiation is an approved Docket No. 03–077–1) a proposal to One commenter requested that we treatment at less than the generic dose, amend the regulations by making also provide for the use of irradiation to and provide for the use of irradiation as several amendments to the irradiation treat cut flowers and foliage that are a treatment for cut flowers and foliage. treatment regulations for imported fruits subject to treatment requirements in the These actions will allow the use of and vegetables, for fruits and vegetables regulations. irradiation to neutralize more pests and moved interstate from Hawaii, Puerto We agree that cut flowers and foliage to neutralize some pests at lower doses. Rico, and the U.S. Virgin Islands, and that are hosts of pests for which Furthermore, we are providing for the for regulated articles moved interstate irradiation is an approved treatment can irradiation of fruits and vegetables from areas quarantined for Mexican fruit be treated at the pest-specific doses moved interstate from Hawaii at the fly or Mediterranean fruit fly. We also provided in this final rule. Therefore, in pest-specific irradiation doses that are proposed to provide for the use of this final rule we have amended the now approved for imported fruits and irradiation treatment for bananas moved phytosanitary treatment regulations as vegetables. We are also providing for the interstate from Hawaii and to provide well as the Hawaiian and territorial use of irradiation to treat fruits and for the use of a vapor heat treatment for quarantine regulations to provide for the vegetables moved interstate from Puerto sweetpotatoes moved interstate from use of irradiation to treat cut flowers Rico and the U.S. Virgin Islands. These Hawaii. and foliage. Specifically, we have actions will allow irradiation to serve as On June 20, 2005, the Federal amended paragraph (a) of § 305.31 to an alternative to other approved Register published a correction (70 FR provide that irradiation at the pest- treatments for additional commodities 35500) to the table in § 305.31(a) of our specific doses may be used to treat cut moved interstate from Hawaii, Puerto proposal in which the generic dose for flowers and foliage. We have also Rico, and the U.S. Virgin Islands. all pests of the phylum Arthropoda, amended § 305.31 by replacing the Finally, we are adding irradiation as a excluding adults and pupae of the order words ‘‘fruits and vegetables’’ with the treatment for bananas from Hawaii and , was corrected to read 400 word ‘‘article’’ each time they occur. adding vapor-heat treatment as an gray. Sections 305.34, 318.13–4f, and 318.58– optional treatment for sweetpotatoes We solicited comments concerning 4b provide administrative instructions from Hawaii. These actions will provide our proposal for 60 days ending August for irradiation treatment of certain fruits

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and vegetables from Hawaii, Puerto pests. It is true that several technologies lowering the dose for West Indian fruit Rico, and the U.S. Virgin Islands, under development may also provide fly to 70 Gy. respectively. We have amended these effective treatments for various plant We have reviewed the research sections by replacing the words ‘‘fruits pests (e.g., pressure treatments, submitted by the commenter and agree and vegetables’’ with the word ‘‘article’’ controlled atmosphere, and laser that the dose for West Indian fruit fly each time they occur. Finally, we have ultraviolet light pulses). To date, we (Anastrepha obliqua) should be lowered amended the cut flowers regulations in have not seen conclusive scientific to 70 Gy and have done so in this final § 319.74–2 by adding a new paragraph documentation that establishes standard rule. (d) to indicate that cut flowers may be methodologies for these treatments, or Two commenters stated that it was treated at the pest-specific irradiation that demonstrates that these treatments unnecessary to list green scale in the doses listed in § 305.31(a). Cut flowers effectively control pests of concern in pest table in § 305.31 because it requires and foliage are also subject to the fruits and vegetables subject to APHIS the generic dose (400 Gy). One packaging requirements provided in regulations. APHIS is always willing to commenter noted that this implied that §§ 305.31 and 305.34 of the regulations. evaluate petitions to add new treatments 400 Gy was the lowest possible dose Irradiation may have negative effects to our import regulations. Petitioners that can control green scale. The second on the quality of cut flowers, and the should submit a detailed description of commenter added that there has been no shipper and facility operator are the methodology and standards of the large-scale research done on this dose, responsible for determining tolerance of treatment to be evaluated, and should but that preliminary research at the cut flowers to treatment. APHIS include any scientific studies that University of Hawaii suggested 250 Gy assumes no responsibility for any loss or document the effectiveness of the would control green scale. damage that may result in the use of treatment and related issues (e.g., We agree with these commenters and irradiation. quality effects on treated articles). have amended the table in § 305.31(a) by removing the entry for Coccus viridis, Use of Irradiation To Control Pests One commenter stated that the green scale. Two commenters objected to the use proposed rule could stimulate the One commenter recommended adding of irradiation to treat imported fruits construction of more irradiation a statement in the final rule that lower and vegetables. One commenter stated facilities, some of which could use irradiation doses might be sufficient for that food in the United States has been radioactive cobalt-60 or cesium-137, the plant pests being added in this rule altered so much that it has become which Federal regulations permit. The in order to encourage more research on inferior to food in Europe. A second commenter stated that these facilities minimum irradiation levels. commenter stated that APHIS should will pose serious risks to the We are not making any changes as a not employ irradiation as a treatment communities where they are built. result of this comment. As stated but should instead use other treatments We are not making any changes in previously in this document, APHIS is and procedures to prevent the response to this comment. The safety of always willing to evaluate research that introduction of dangerous plant pests operations of irradiation facilities is supports new treatments or changes to associated with imported fruits and regulated by the Nuclear Regulatory existing treatments such as lowering the vegetables. This second commenter Commission (NRC). NRC ensures that required doses for irradiation. added that irradiation has not been such facilities are built and operated Petitioners should submit any scientific shown to be a safe, effective, or viable according to Federal regulations. To be studies that document the effectiveness means to eradicate invasive pests and licensed, the facility must have been of the dose, and APHIS will consider that the U.S. Department of Agriculture designed with multiple fail-safe each request as it is presented. should cease pursuing irradiation as a measures, and must establish extensive One commenter recommended treatment for plant pests. and well-documented safety procedures rounding irradiation doses to the nearest We have not made any changes to the and worker training. With proper design 10 Gy increment because dosimeters can rule in response to these comments. and operating procedures, commercial vary by 1 to 2 percent in their accuracy. Importers are free to choose other irradiation facilities can be operated The commenter added that it is difficult treatments authorized by the regulations safely and without posing any during research to accurately apply in lieu of irradiation. The reason that significant radiation risk to workers or doses in less than 10 Gy increments due irradiation may be attractive to certain the public. to variability in the density and importers, particularly those importing consistency of the infested fruit or fresh tropical fruits from fruit fly- Recommended Doses vegetable. infested regions, is that irradiation We are not making any changes in One commenter presented two allows fruits of higher quality to be response to this comment. We believe studies 1 which demonstrated that imported. Alternative heat, cold, and that the measures we have in place to Mexican fruit fly (Mexfly) is more fumigation treatments can cause monitor and administer irradiation radiotolerant than West Indian fruit fly, unacceptable phytotoxicity (damage to treatment will ensure that at least the but noted that we proposed an the fruits). Also, these alternative appropriate minimum dose is irradiation dose of 100 Gy for West treatments often must be used on fruit administered. When applying Indian fruit fly and only 70 Gy for harvested before it is fully ripe. The irradiation treatment, several factors are Mexfly. The commenter recommended irradiation alternative allows importers taken into account, including geometry to sell riper, more valuable fruit, with of the source, the dimensions of the 1 less damage. Bustos, M.E., Enkerlin, W., Reyes, J., and irradiation container, as well as the Toledo, J. 2004. Irradiation of mangoes as a In authorizing irradiation treatments, postharvest quarantine treatment for fruit flies bulk-density of the load and its we have considered both the efficacy (Diptera: Tephritidae). J. Econ. Entomol. 97: 286– distribution. Recording of process and the environmental effects of 292. parameters and dosimetry is required to irradiation compared to other treatments Hallman, G.J. and Worley, J.W. 1999. Gamma ensure that the treatments applied are radiation doses to prevent adult emergence from already authorized by our regulations. immatures of Mexican and West Indian fruit flies within the limits established by APHIS. The irradiation treatments in the final (Diptera: Tephritidae). J. Econ. Entomol. 92: 967– Further, the available data indicate that rule are effective against the listed plant 973. the doses we proposed are the lowest

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effective doses necessary to achieve inspection for banana and green vine borer and specifying a minimum phytosanitary security; thus, rounding a scale as an additional mitigation irradiation dose of 150 Gy for both dose up to the nearest 10 Gy increment measure. We agree with this commenter pests. We have also reduced the would have the effect of requiring more that the configuration of bananas on the minimum irradiation dose for than the minimum dose and would be stalk makes visual inspection more sweetpotato weevil from 165 Gy to 150 contrary to our World Trade difficult. Therefore, we have amended Gy. Organization (WTO) agreements. § 318.13–4i, paragraphs (b)(1) and (b)(2), With these changes, all but one of the in this final rule to specify that bananas pests of concern for sweetpotatoes from Safeguards on Commodity Movement must be removed from the stalk during Hawaii for which irradiation is an Two commenters noted that we inspection. authorized treatment may be treated should put in place safeguards, such as One commenter suggested that we with a minimum irradiation dose of 150 sealed containers, against plant pest allow green bananas from Hawaii grown Gy. The exception is the ginger weevil spread for untreated commodities that under the systems approach to be (Elytrotreinus subtruncatus), which are moved to the mainland United irradiated at 400 Gy if found to be requires a minimum irradiation dose of States for treatment. One of the infested with green scale or to have 400 Gy. (The regulations also require commenters suggested prohibiting certain defects that would otherwise inspection for two other pests for which movement of untreated commodities trigger rejection upon inspection. irradiation is not an authorized with pretreated commodities and We agree with this commenter and treatment, i.e., the gray pineapple adding protocols for transport and have amended § 318.13–4i in this final mealybug [Dysmicoccus neobrevipes] containment upon arrival. rule by revising paragraph (b), and the Kona coffee-root knot nematode Section 305.34 of the regulations sets introductory text, to state that ‘‘Bananas [Meloidogyne konaensis]). In the forth instructions for fruits and of any cultivar or ripeness that do not proposed rule, we proposed to add a vegetables shipped from Hawaii to the meet the conditions of paragraph (a) of vapor heat treatment option for mainland United States, including this section may also be moved sweetpotato from Hawaii that included safeguards for untreated commodities interstate from Hawaii with irradiation provisions for the sampling, cutting, and being shipped to the mainland United in accordance with the following inspection of sweetpotatoes for the States for treatment. For imported fruits conditions.’’ ginger weevil, and we are adopting and vegetables, § 305.31, paragraph those proposed provisions in this final Sweetpotatoes (g)(1) prohibits packaging irradiated rule (see § 318.13–4d in the regulatory fruits and vegetables with nonirradiated One commenter questioned whether text at the end of this document). To fruits and vegetables and paragraph early stages of Kona coffee root-knot harmonize the irradiation treatment (g)(2) provides packaging provisions for nematode could be found by visual provisions for sweetpotatoes from fruits and vegetables irradiated prior to inspection. Hawaii with those new vapor heat entering the United States to prevent the We have found inspection to be very provisions, we have amended the entry of fruit flies. However, § 305.31 effective at detecting nematodes of all regulations in § 305.34 in this final rule does not contain packaging provisions stages. to offer two irradiation treatment for imported fruits and vegetables to be One commenter suggested that the options: The existing 400 Gy dose or a irradiated upon arrival in the United regulations should provide that the 150 Gy dose supplemented by sampling, States. Therefore, we are amending required probes be placed in the largest cutting, and inspection for the ginger § 305.31(g) in this final rule by adding roots when applying heat treatment to weevil, with the sampling, cutting, and a new paragraph that requires cartons of sweetpotatoes. inspection requirements being the same untreated regulated articles being We agree that inspectors should locate as those found in the vapor heat imported into the United States for temperature probes in the largest provisions in § 318.13–4d. The treatment to be shipped in shipping potatoes when applying heat treatment. inspection requirements for the gray containers sealed prior to importation Therefore, we have amended pineapple mealybug and the Kona root- with seals that will visually indicate if § 305.24(k)(1) in this final rule to knot nematode will continue to apply to the shipping containers have been provide that temperature probes must be sweetpotatoes treated at both the 400 Gy opened. These provisions we have placed in the approximate center of the and 150 Gy dose. To effect this change, added regarding imported articles ‘‘largest individual sweetpotato roots.’’ we have amended § 305.34(b)(7)(i) and mirror those in § 305.34 for untreated One commenter stated that recent (ii) in this final rule to reflect the new 2 articles moved from Hawaii to the research indicates that sweetpotato inspection requirement for ginger mainland United States for treatment. weevil, West Indian sweetpotato weevil, weevil if sweetpotatoes are to be and sweetpotato vine borer can all be irradiated at 150 Gy; a new footnote in Bananas from Hawaii neutralized with a dose of 150 Gy. The the entry for sweetpotato in the table in One commenter stated that the commenter asked that we add West paragraph (a)(1) of that section directs configuration of bananas on the stalk Indian sweetpotato weevil and the reader to § 305.34(b)(7)(i) and (ii). make visual inspections an ineffective sweetpotato vine borer with a dose of Because litchi from Hawaii is also detection method. The commenter 150 Gy and that we change the dose for subject to additional inspection added that the lethal dose for banana sweetpotato weevil to 150 Gy. requirements in § 305.34(b)(7), the entry moth should be determined before After reviewing the research provided for litchi in the table has also been including this commodity in the by the commenter, we have amended annotated with a reference to that regulations. the table in § 305.31(a) in this final rule footnote. We have determined that the generic by adding entries for West Indian dose of 400 Gy would be sufficient for sweetpotato weevil and sweetpotato Pineapples From Hawaii banana moth larvae; however inspection One commenter asked that we delete is necessary for pupae and adults of this 2 Follett, Peter A. Irradiation for postharvest the reference to ‘‘other than smooth control of anastomosalis (Lepidoptera: pest. Bananas may also undergo Pyralidae), Euscepes postfaciatus and Cylas Cayenne’’ in the entry for pineapples in irradiation treatment at a dose of 150 Gy formicarius elegantulus (Coleoptera: Curculionidae) § 305.34, paragraph (a)(1). The for fruit flies, which would require in sweetpotatoes. commenter noted that this would allow

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all varieties of pineapple to be treated plant pests in the International Plant commenter noted that we made no by irradiation for plant pests in Protection Convention Guidelines for mention of any financial considerations accordance with § 305.31(a) and the Use of Irradiation as a Phytosanitary taken into account. § 305.34(a)(2). Measure (ISPM Publication No. 18) as While economic benefits result from The commenter is correct. We recommended minimum dose ranges. our lowering of irradiation doses, they mistakenly included the reference to The commenter stated that these doses are not the reason for our doing so. ‘‘other than smooth Cayenne’’ when in are only estimates. Under WTO agreements, we are obliged fact, all varieties of pineapple are We acknowledge that we incorrectly to base our regulations on sound eligible for irradiation. We have characterized the estimates as science; to ignore research that showed amended the entries for pineapple in recommended minimum doses. That lower irradiation doses to be effective § 305.34(a)(1) and § 318.13–4f by statement appeared in the would be contrary to these agreements. removing the words ‘‘(other than supplementary information of the One commenter stated that the smooth Cayenne).’’ proposed rule, however, so there is no proposed rule would open up large need to make any changes to the parts of the United States to increased General Comments regulations in this document. risks of infestation. The commenter In the supplementary information of Two commenters stated that research stated that our reasoning that fruit flies our proposed rule, we stated that mites did not demonstrate that all fruit flies of would not survive irradiation treatment are not arthropod plant pests. Two the family Tephritidae would be or weather conditions in many areas of commenters noted that mites are neutralized by a dose of 150 gray. the United States was faulty. The arthropod plant pests and that we The commenters are correct in that, commenter added that while the rule should not use the term ‘‘arthropod.’’ technically, all fruit flies of the family only applies to 12 species of fruit flies, We agree with the commenters have Tephritidae were not tested, but all of there are numerous hosts in the United amended the last row in the table in the fruit flies that were tested in this States that would be susceptible to those § 305.31 by changing the words family were neutralized by this dose. fruit flies. ‘‘phylum Arthropoda’’ to ‘‘class Therefore, we consider the results from We agree that preventing the Insecta.’’ the fruit flies we tested to be applicable introduction of exotic fruit flies into the One commenter suggested that we to the entire Tephritidae family. United States is of the utmost should explain to inspectors what they However, we agree that it would have importance. According to ARS, 150 Gy can expect to find with properly been clearer to state that ‘‘we consider will be sufficient to neutralize all fruit irradiated commodities (e.g., live fruit all fruit flies of the family Tephritidae flies and that doses lower than 150 gray flies and perhaps eggs, but no further to be neutralized by a dose of 150 gray.’’ are sufficient to neutralize certain development from either). In the supplementary information of species of fruit flies. We believe that Customs and Border Protection and the proposed rule, we stated that treatment of fruits, vegetables, cut APHIS inspectors are trained as to what required irradiation doses were specific flowers, and foliage at these doses, they might specifically find in to plant pests rather than to the when properly administered, will be commodities treated by irradiation and commodities with which they are sufficient to prevent the introduction of have been inspecting irradiated fruit associated, which reflects the fact that fruit flies via commodities treated by moved interstate for more than a the effectiveness of irradiation treatment irradiation. decade. Therefore, it is unnecessary to is dependent on the dose that is include such information in this final absorbed by the commodity. One Economic Analysis rule. commenter considered this statement One commenter suggested that our One commenter suggested that we misleading, noting that it suggests that economic analysis should take note of include a provision to prohibit the radiation is absorbed by the some advantages to irradiation, such as irradiation of low-oxygen-stored commodity thereby killing the . the fact that fruit that is to be irradiated produce until research on the The commenter added that the doses are can be allowed to ripen longer on the effectiveness of irradiation on such specific to the pest rather than tree, resulting in higher-quality fruit. produce can be completed. The commodity because the commodity We have added a paragraph commenter stated that a recent study provides limited shielding for the insect highlighting additional advantages of showed that four pests showed an from the ionizing radiation. irradiation over some other treatments increase in radiotolerance when stored We agree with this commenter, but to the economic analysis in this final in such conditions. because this statement appeared in the rule. We have no evidence to either supplementary information of the One commenter stated that it is naive support or refute the commenter’s proposed rule, there is no need to make to assume that there are markets for concern with the response of pests in any changes to the regulations in this irradiated fruits and vegetables in the low-oxygen-stored produce to document. United States. The commenter noted irradiation, but agree that irradiation In the proposed rule, we referred to that since the FDA legalized the should be only applied to articles that minimum doses as ‘‘pest-specific.’’ One irradiation of fruits and vegetables in have been stored under certain commenter suggested that we use either 1986, very few types of irradiated conditions. Because these conditions ‘‘pest species-specific’’ or ‘‘individual produce have been sold in U.S. grocery may vary based on the specific pest-specific.’’ stores. The commenter also cited the commodity, pest of concern, or country We are not making changes in financial troubles of a company that of origin, we will address specific response to this comment. We prefer the stood to benefit from irradiation as an storage conditions in the operational general term ‘‘pest-specific’’ which can example of the lack of a market for work plan or the compliance agreement apply to both individual pests or a pest irradiated fruit in the United States. with plant health officials in the areas group (e.g., all fruit flies). The proposed rule and this final rule where commodities are produced, In the proposed rule, we stated that are concerned with the phytosanitary packed, and treated. fruit quality problems associated with security of fruits and vegetables and not One commenter stated that we high irradiation doses prompted us to their marketing. Our regulations offer incorrectly classified the dose ranges for examine lowering doses. One various treatment options; whether or

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not producers or distributors choose to pending the resolution of commenter’s doses listed in § 305.31(a) and in use irradiation when it is available is up FOIA request concerning an entirely accordance with the other conditions to them. separate rulemaking. The APHIS FOIA specified in § 305.34. staff is working to address the request Section 305.34 has only provided for Miscellaneous referred to by the commenter. irradiation treatment of fruits and Two commenters pointed out several Therefore, for the reasons given in the vegetables from Hawaii; however, we nonsubstantive editorial errors in the proposed rule and in this document, we have determined that irradiation proposed rule. We appreciate the are adopting the proposed rule as a final treatment can be used effectively for commenters bringing these errors to our rule, with the changes discussed in this commodities from Puerto Rico and the attention and wherever appropriate, document. U.S. Virgin Islands if the safeguards in have made the corrections in this § 305.34 are implemented. Currently, no document. Executive Order 12866 and Regulatory irradiation facilities exist in Puerto Rico Flexibility Act or the U.S. Virgin Islands, and no Other Comments This rule has been reviewed under requests have been received to approve One commenter suggested that in Executive Order 12866. For this action, the construction of such facilities. light of the availability of the generic the Office of Management and Budget However, this rule provides for the irradiation dose, we reconsider our has waived its review under Executive option of moving the commodities current pest risk analysis process and Order 12866. under limited permit to an irradiation require evidence only that the few target This rule makes several amendments facility on the U.S. mainland for pests that could not be treated to the current provisions for the use of treatment prior to entering interstate effectively with irradiation are not irradiation as a treatment for various commerce. present in a particular country or are not plant pests, allows the use of irradiation Economic Effects on Small Entities of pests of concern for a particular and inspection as a treatment for Changes in Irradiation Treatment commodity, rather than requiring that a bananas moved interstate from Hawaii Provisions list all possible pests be considered in as an alternative to the systems the pest risk analysis. approach currently described in the The Regulatory Flexibility Act We agree with this commenter that regulations, and allows the use of a requires that agencies specifically the availability of the generic irradiation vapor heat treatment for sweetpotatoes consider the economic impact of their dose may simplify the pest risk analysis moved interstate from Hawaii as an regulations on small entities. The Small process for commodities from countries alternative to fumigation with methyl Business Administration (SBA) has where pests that can be targeted with bromide and irradiation. The potential established size criteria using the North the generic dose exist. We expect that a economic impacts of the changes are American Industry Classification pest list would still have to assembled discussed below. System (NAICS) to determine which in most cases, but the risk management economic entities meet the definition of aspect of the risk analysis process could Irradiation Treatment for Fruits, a small firm. be abbreviated if the risks associated Vegetables, Cut Flowers, and Foliage Irradiation facilities affected by this with all identified quarantine pests The regulations in § 305.31 set out rule will belong to one of the following could be addressed through the standards, minimum doses, and other two NAICS categories: (1) Firms application of the generic irradiation requirements for performing irradiation providing irradiation services for the dose. If quarantine pests that could not treatments on imported fruits, treatment of fruits and vegetables, be addressed using the generic dose vegetables, cut flowers, and foliage and which would fall within NAICS were identified in the pest list, then the set out minimum doses necessary to category 115114, ‘‘Postharvest Crop risk management analysis could be neutralize 11 fruit flies and the mango Activities (except Cotton Ginning)’’; or limited to examining mitigation seed weevil. This rule adds minimum (2) firms providing irradiation services measures for those pests alone. doses for more pests and lowers the for decontamination or sterilization The commenter also requested that minimum doses for others. Specifically, purposes, which would fall within we reconsider the requirement that this rule establishes: NAICS category 811219, ‘‘Medical and every new commodity must be added to • A minimum generic dose of 400 Gy surgical equipment repair and the regulations through rulemaking for all plant pests of the class Insecta maintenance services.’’ before being eligible for entry into the other than pupae and adults of the order Most treatments of Hawaiian produce United States. Lepidoptera; are likely to occur at an existing While we are unable to make any • A minimum generic dose of 150 Gy irradiation facility on the island of changes in this document in response to for all fruit flies of the family Hawaii. This facility is used to treat this comment, we are currently Tephritidae; other fruits and vegetables for which developing a proposed rule that would • Lower minimum doses for certain irradiation is an approved treatment and redesign the fruits and vegetables fruit flies; and can be classified under NAICS category regulations to provide for the evaluation • New approved minimum doses for 115114. The SBA criteria classify this and approval or denial of new import 10 plant pests. facility as a small entity, since its requests in a more expeditious and This rule also allows irradiation to annual sales are less than $6 million. effective manner. serve as an alternative to other approved Another firm on the U.S. mainland One commenter asked that we treatments for additional articles moved operates two facilities in Illinois and postpone the comment period for the interstate from Hawaii, Puerto Rico, and one facility in New Jersey. Its primary proposed rule because a request the U.S. Virgin Islands. Articles from service is to provide irradiation submitted by her organization under the Hawaii, Puerto Rico, and the U.S. Virgin treatment for the sanitation of medical Freedom of Information Act (FOIA) Islands that are required to be treated by devices on contract. This firm is regarding another rulemaking related to other means for pests listed in classified within NAICS category irradiation had not yet been fulfilled. § 305.31(a) prior to interstate movement 811219. However, since it is part of a We do not believe it is necessary or will be allowed to be moved interstate larger corporation for which annual appropriate to delay this final rule if they are treated with irradiation at the receipts may exceed $6 million, this

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firm is not classified as a small entity Irradiation and Inspection for Bananas interstate greater flexibility in under the SBA criteria. Thus, at least Moved Interstate from Hawaii operations, more choices with regard to one firm that could be affected by this The regulations in § 318.13–4i have the types of bananas moved interstate, a rule is a small entity. provided that green bananas (Musa spp.) greater volume of bananas to ship, and Irradiation facilities, whether large or of the cultivars ‘‘Williams,’’ ‘‘Valery,’’ less risk of facing rejections during small, will benefit from this rule. The ‘‘Grand Nain,’’ and standard dwarf inspection under the systems approach range of commodities imported and ‘‘Brazilian’’ may be moved interstate and Banana Compliance Agreement. moved interstate for which irradiation from Hawaii under a systems approach. Growers have been reluctant to ship will be an approved treatment will At this time, only green bananas of these bananas to U.S. mainland markets under increase. At the same time, dosage specified cultivars have been eligible for the systems approach because § 318.13– levels, and therefore operating costs, interstate movement under those 4i(c) of the regulations has required that will decrease for many commodities. provisions. bananas to be moved interstate be The changes to irradiation doses and We are adding two combinations of inspected by an inspector and found provisions allowing the use of pest- irradiation and inspection as treatments free of the following defects: for bananas from Hawaii. Specifically, specific doses to treat commodities for Prematurely ripe fingers, fused fingers, bananas, regardless of cultivar or interstate movement will facilitate the or exposed flesh (not including fresh ripeness, from Hawaii will be eligible importation of fruits, vegetables, cut cuts made during the packing process). for interstate movement if they have flowers, and foliage and their interstate been inspected in Hawaii for adults and Bananas moved interstate from Hawaii movement from Hawaii, Puerto Rico, pupal stages of the banana moth under this systems approach are and the U.S. Virgin Islands. For certain Opogona sacchari (Bojen), and have required to be free of these defects pests for which irradiation is already an undergone irradiation treatment with a because they are conducive to fruit fly approved treatment, required irradiation minimum dose of 400 gray at an infestation. However, growers are dosages will be lowered to the approved facility. Bananas from Hawaii concerned about the risk of having minimum level necessary. In other will also be eligible for interstate whole shipments of fruit prohibited instances, irradiation will be newly movement if they have been inspected from interstate movement as a result of allowed as an alternative phytosanitary in Hawaii for the banana moth and the a single fault detected when bananas in treatment. green scale, Coccus viridis (Green), and a random selection of boxes are This rule will result in lower costs have undergone irradiation treatment inspected. No commercial container and increased flexibility for importers, with a minimum dose of 150 gray at an shipments of bananas have been made gains that could be expected to be at approved facility. to U.S. mainland markets under the regulations in effect prior to this rule. least partly realized by U.S. consumers Cost of Irradiation Treatment through lower prices, assuming Since the irradiation treatment options The cost of irradiation is estimated at competitive markets. For some provided by this rule are sufficient to 15 cents per pound.3 We expect that commodities, irradiation may also neutralize fruit flies and other pests of most bananas moved interstate from provide quality advantages over other concern, irradiation will provide the Hawaii under this approach will be treatment methods in terms of increased Hawaiian banana industry with an treated at the existing commercial alternative treatment for interstate shelf life. Irradiation allows fruits and irradiation facility on the island of vegetables of higher quality to be movement and could open new Hawaii. However, the treatment could marketing opportunities. imported. Alternative heat, cold, and be performed at the irradiation facilities fumigation treatments can cause on the mainland United States as well. U.S. consumers will benefit from an unacceptable damage to fruits, increased supply of bananas. Growers in vegetables, cut flowers, and foliage. At Cost of APHIS Inspection Hawaii believe that the U.S. mainland this time, we are unsure as to the extent Monitoring of quarantine treatments demand for bananas from Hawaii may of damage the use of irradiation may conducted during standard business be equivalent to (if not higher than) the cause to certain cut flowers and it is hours (weekdays between 8 a.m. and existing demand for Hawaiian papaya. entirely the importer’s or owner’s 4:30 p.m.) on the island of Hawaii Hawaiian growers moved approximately responsibility to assess which treatment comes at no cost to the facility. APHIS 12 million pounds of papayas to U.S. should be used with each variety of cut charges for the monitoring of treatments mainland markets in 2003.4 Demand flowers. Also, these alternative conducted before 8 a.m. and after 4:30 may be especially high for the apple treatments often must be used on fruit p.m. and on weekends at a time-and-a- banana variety, which has a higher harvested before it is fully ripe. half rate. sugar content and more aromatic flavor Irradiation allows importers to sell Benefits than the standard commercial banana riper, more valuable fruit, with less varieties currently available in U.S. damage. Choice of irradiation as a The combination of irradiation mainland markets. Consumers will treatment alternative would rest upon treatment and inspection will offer an benefit from the availability of this its expected net returns relative to other alternative to the systems approach for specialty product. green fruit of the specified four banana treatment methods. cultivars, and will allow fruit of any Hawaii accounts for almost all U.S. 5 Because these changes will have the ripeness or cultivar to be moved banana production. In 2002, there were 6 potential to affect the importation or interstate from Hawaii. The approach 677 banana farms in Hawaii, and the interstate movement of a wide range of described in this rule can be used to value of sales amounted to $ 8.6 commodities, it is difficult to predict mitigate the pest risk associated with all exactly what economic effects these Hawaiian bananas, regardless of cultivar 4 Source: Hawaii Department of Agriculture. changes will have. However, while or ripeness. This will allow banana 5 The Census of Agriculture (2002) reports minimal acreage in California, Florida, and Texas, affected irradiation firms, large and producers and parties moving bananas which together account for only 131 acres. small, are expected to benefit, we do not 6 National Agricultural Statistics Service, 2002 expect the impacts to be significant. 3 Source: Hawaii Department of Agriculture. Census of Agriculture.

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million.7 Table 1 summarizes production of bananas amounted to 19.5 production information for bananas and million pounds in 2002. papayas in Hawaii. The utilized

TABLE 1.—PRODUCTION STATISTICS FOR BANANAS AND PAPAYAS IN HAWAII (2002)

Item Bananas Papayas

Bearing acreage (acres) ...... 1,300 ...... 1,720. Utilized production (1,000 pounds) ...... 19,500 ...... 45,900. Price (per pound) ...... $0.430 ...... $0.260. Value of utilized production ...... $8.385 million ...... $11.924 million. Movement to mainland U.S. markets (1,000 pounds) ...... None ...... 12,000. Sources: Hawaii Department of Agriculture (movement statistics) and National Agricultural Statistics Service.

The United States imported 7,883 Noncitrus Fruit Farming.’’ The SBA have to be determined. This estimate of million pounds (3,576 million kg) of considers entities in this category to be treatment cost also does not include a fresh bananas in 2003, valued at $959 small if their average annual receipts are markup for the facility. The markup will million.8 Ecuador, Costa Rica, less than $750,000. The 677 banana be determined by the number of plants Guatemala, Colombia, and Honduras farms in Hawaii accounted for annual providing service and the demand for accounted for 97 percent of the quantity sales of $8.6 million in total in 2002. service. Therefore, it is likely that most of imports (table 2). Compared to the Cost of APHIS Inspection for Vapor Hawaiian banana farms will be 7,883 million pounds of bananas Heat Treatment or Irradiation currently imported, Hawaii’s total classified as small entities under the production of 20 million pounds is SBA criteria. The treatment monitoring Monitoring of quarantine treatments extremely small, and it is not likely that program will be mainly operated by conducted during standard business 100 percent of the State’s production APHIS personnel, and no impact is hours (weekdays between 8 a.m. and will be moved to the mainland United anticipated on other small entities or 4:30 p.m.) on the island of Hawaii States. Thus, as long as phytosanitary government agencies. comes at no cost to the facility. APHIS charges for the monitoring of treatments mitigation by means of the approved Vapor Heat Treatment for treatments is maintained, the interstate conducted before 8 a.m. and after 4:30 Sweetpotatoes Moved Interstate From p.m. and on weekends at a time-and-a- movement of bananas from Hawaii is Hawaii unlikely to significantly affect current half rate. We are allowing vapor heat treatment, U.S. trade in fresh bananas. Comparison of Vapor Heat Treatment, combined with tuber cutting and visual Irradiation, and Methyl Bromide TABLE 2.—QUANTITY AND VALUE OF inspection, to be used as a treatment for Vapor heat treatment will provide the FRESH BANANAS IMPORTED INTO sweetpotatoes moved interstate from Hawaii. We believe this treatment will Hawaiian sweetpotato industry with an THE UNITED STATES FROM THE FIVE be an effective alternative to the methyl alternative treatment to irradiation or MAJOR EXPORTING COUNTRIES bromide and irradiation treatments methyl bromide fumigation. If vapor (2003) currently prescribed by the regulations heat treatment can be performed at 2 to to control pests of concern. 3 cents per pound, it will constitute the Quantity Value most cost-effective treatment, compared Country (million U.S. Cost of Vapor Heat Treatment (million kg) dollars) to irradiation at 15 cents per pound and Hawaii has three packing plants on fumigation costs ranging from 40.6 cents Ecuador ...... 902 237.8 the Island of Hawaii that provide vapor per pound for 1 pallet to 6.7 cents per Costa Rica ...... 901 247.5 heat treatment services. No other vapor pound for 12 pallets (table 3). (These are Guatemala ...... 868 229.1 heat treatment plants are currently in treatment costs only and do not include Colombia ...... 429 117.7 operation elsewhere in the State. Since the costs of APHIS monitoring or Honduras ...... 388 100.4 APHIS has yet to certify a facility for the inspection activities or inter-island treatment of sweetpotato by vapor heat, transportation costs necessary to Total im- ports ...... 3,576 959.3 the costs of treating this crop perform treatments.) specifically cannot be determined with Source: World Trade Atlas (2003). certainty at this time. However, one of TABLE 3.—ESTIMATED PER-UNIT COST Economic Effects on Small Entities of the packinghouses estimated that vapor OF VAPOR HEAT TREATMENT, IRRA- Irradiation and Inspection Provisions heat treatment costs could amount to 2 DIATION, AND METHYL BROMIDE FU- for Bananas to 3 cents per pound for the required MIGATION treatment protocol. This estimate Most treatments of Hawaiian bananas considered the costs of labor, electricity, Per unit are likely to occur at the existing water, and sewer service. APHIS has Treatment cost irradiation facility on the island of traditionally certified vapor heat (cents per pound) Hawaii, which, as noted previously, is treatment chambers (for example, for considered a small entity. papaya) in the ‘‘fully loaded Vapor heat treatment ...... 2–3 Banana farming is classified under configuration.’’ The costs of treating Irradiation ...... 15 NAICS category 111339 as ‘‘Other sweetpotato in smaller batch loads still

7 From http://www.nass.usda.gov/hi/fruit/ 8 World Trade Atlas, 2003. annban.htm. Sales of Hawaiian bananas in 2003 were valued at $9.225 million.

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TABLE 3.—ESTIMATED PER-UNIT COST TABLE 4.—PRODUCTION STATISTICS TABLE 6.—PRODUCTION AND UTILIZA- OF VAPOR HEAT TREATMENT, IRRA- FOR HAWAIIAN SWEETPOTATOES TION STATISTICS FOR DIATION, AND METHYL BROMIDE FU- (2001) SWEETPOTATOES IN THE UNITED MIGATION—Continued STATES (2003) 1—Continued Item Amount Per unit Item Amount Harvested acres ...... 220 Treatment cost (cents per Yield per acre (1,000 pounds) .. 8.2 Three-year average per capita pound) Production (1,000 pounds) ...... 1,800 use (pounds) ...... 4.0 Farm price (cents per pound) 1 50 Current dollars ($/cwt) ...... 15.75 Methyl bromide fumigation: 1 Constant 1996 dollars ($/cwt) 13.91 One pallet ...... 40 .6 1 The 2001 farm price for sweetpotato was 47.3 cents per pound in Hawaii, Honolulu, and 1 Two pallets ...... 20 .3 Estimates are for the total United States, the Kauai Counties, and 60 cents per pound in and therefore include Hawaii. Forecasted esti- Three pallets ...... 13.5 the Maui County (Hawaiian Department of Ag- mates are shown. Four pallets ...... 10 .1 riculture). 2 Total utilization includes 103 million Five pallets ...... 8 .1 Source: Hawaii Agricultural Statistics pounds used for seed and 67.8 million pounds Six pallets ...... 6 .7 Service. accruing to feed use, shrink, and loss. Source: Economic Research Service, United Nine pallets ...... 7 .6 In the mainland United States, States Department of Agriculture. Acres were Twelve pallets ...... 6.9 sweetpotato is grown commercially in obtained from Lucier, G. ‘‘Sweet potatoes— getting to the root of demand.’’ Economic Re- 1 One pallet contains 1,500 pounds of Alabama, California, Georgia, Louisiana, search Service, USDA, 2002. sweetpotatoes. Mississippi, New Jersey, North Carolina, Sources: Packinghouse estimate (vapor South Carolina, Texas, and Virginia. The Hawaiian sweetpotatoes intended heat treatment); Hawaii Department of Agri- North Carolina, Louisiana, Mississippi, for the U.S. mainland markets are of a culture (irradiation and methyl bromide special purple flesh variety, and they fumigation). and California account for the major proportion of production area by State are therefore shipped to the mainland as The availability of vapor heat (table 5). In total, the United States a specialty product intended for niche treatment thus provides the Hawaiian produced 1,355 million pounds of markets. U.S. mainland consumers sweetpotato industry with an alternative sweetpotatoes from 93,500 acres in 2003 could, therefore, benefit from an increased supply of these specialty treatment option at a competitive cost. (table 6). The Hawaiian sweetpotato production of 1.8 million pounds thus sweetpotatoes. Furthermore, the vapor heat treatment Interstate movement provides comprises a minor proportion of the plants in Hawaii will benefit if Hawaiian growers and shippers with total production of 1,355 million sweetpotatoes are included in the list of increased marketing opportunities. pounds in the United States. agricultural products to be treated. The Sweetpotatoes are in year-round availability of vapor heat treatment as production in Hawaii, but some TABLE 5.—ACRES OF an alternative to fumigation might seasonal variation in volume is become increasingly important in view SWEETPOTATOES PLANTED IN THE expected. Out-shipment to U.S. of the global phaseout of methyl UNITED STATES (2003) mainland markets is estimated at 50,000 bromide under the Montreal Protocol. to 60,000 pounds per week. New Acres Irradiation may have positive effects on State planted plantings of the crop have increased on the quality and shelf life of the tubers, the island of Hawaii since irradiation and allows flexibility since both small North Carolina ...... 42,000 was approved as an alternative to and large product lots can be staged for Louisiana ...... 18,000 methyl bromide fumigation in June treatment to meet specific market Mississippi ...... 14,000 2003. However, plantings are likely to demands. Vapor heat treatment is not California ...... 10,100 increase each year if the market demand known to offer quality or shelf-life Texas ...... 3,400 increases for Hawaiian sweetpotatoes Alabama ...... 2,900 benefits to the product, but some regardless of whether the product is Others 1 ...... 3,100 consumers may prefer this option above treated by methyl bromide fumigation, irradiation, or vapor heat treatment. irradiation, especially in , Canada, Total ...... 93,500 and Europe. Nevertheless, even if sweetpotato 1 Including Hawaii. production increases in Hawaii, the Impact on U.S. Sweetpotato Production Source: Economic Research Service, relative volume of production (1.8 USDA. million pounds) remains extremely Commercial sweetpotato production small in comparison to the volume of in Hawaii occurs on the islands of TABLE 6.—PRODUCTION AND UTILIZA- U.S. mainland sweetpotato production Hawaii, Kauai, Maui, and Oahu. In TION STATISTICS FOR (1.36 billion pounds). 2002, there were 59 sweetpotato farms,9 SWEETPOTATOES IN THE UNITED Thus, since Hawaiian production is so and the value of sales was $989,000.10 STATES (2003) 1 small in comparison to U.S. mainland The utilized production of production, and as long as sweetpotatoes in Hawaii was 1.8 million Item Amount phytosanitary mitigation by the pounds in 2001 (table 4). The crop is in approved treatments is maintained, year-round production in Hawaii. Acres planted ...... 93,500 sweetpotato shipments from Hawaii are Three-year average yield (cwt/ acre) ...... 150 unlikely to affect mainland producers. Production (million pounds) .... 1,355 Consumers will benefit from the Imports (million pounds) ...... 17 .0 availability of the purple-fleshed 9 National Agricultural Statistics Service, 2002 Exports (million pounds) ...... 53.0 specialty sweetpotato product, and the Census of Agriculture. Total utilization (million Hawaiian sweetpotato industry will gain 10 From http://www.nass.usda.gov/hi/vegetble/ pounds) 2 ...... 1,148 .3 opportunities to expand its mainland annveg.htm. Per capita use (pounds) ...... 3.9 U.S. markets.

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Vapor Heat Treatment of Sweetpotatoes Paperwork Reduction Act number citation at the end of the section Moved Interstate From Hawaii In accordance with the Paperwork are revised to read as follows: The availability of vapor heat Reduction Act of 1995 (44 U.S.C. 3501 § 301.64–10 Treatments. et seq.), the information collection or treatment at a competitive cost could * * * * * recordkeeping requirements included in divert some sweetpotatoes moved (g) Approved irradiation treatment. this rule have been approved by the interstate from Hawaii from the existing Irradiation, carried out in accordance Office of Management and Budget irradiation facility in Hawaii to a vapor with the provisions of part 305 of this (OMB) under OMB control number heat treatment facility. This will affect chapter, is approved as a treatment for 0579–0281. the existing irradiation facility in any fruit listed as a regulated article in Hawaii, which is a small entity. Government Paperwork Elimination § 301.64–2(a). However, it is not known at this time Act Compliance what proportion of Hawaiian * * * * * The Animal and Plant Health (Approved by the Office of Management and sweetpotatoes moved interstate will be Budget under control number 0579–0088) treated with vapor heat instead of Inspection Service is committed to irradiation. compliance with the Government I 3. In § 301.78–10, paragraph (c) On the other hand, vapor heat Paperwork Elimination Act (GPEA), introductory text is revised to read as treatment facilities could benefit by the which requires Government agencies in follows: addition of vapor heat as an approved general to provide the public the option § 301.78–10 Treatments. treatment for sweetpotatoes moved of submitting information or transacting interstate from Hawaii. However, since business electronically to the maximum * * * * * facilities for the vapor heat treatment of extent possible. For information (c) Approved irradiation treatment. pertinent to GPEA compliance related to Hawaiian sweetpotatoes have not been Irradiation, carried out in accordance this rule, please contact Mrs. Celeste certified yet, the businesses cannot be with the provisions of part 305 of this Sickles, APHIS’ Information Collection conclusively categorized into small or chapter, is approved as a treatment for Coordinator, at (301) 734–7477. large entities at this time. any berry, fruit, nut, or vegetable listed Sweetpotato farming is classified List of Subjects as a regulated article in § 301.78–2(a) of under NAICS category 111219, ‘‘Other this subpart. 7 CFR Part 301 Vegetables (except Potato) and Melon * * * * * Farming.’’ According to the SBA’s Agricultural commodities, Plant criteria, an entity involved in crop diseases and pests, Quarantine, PART 305—PHYTOSANITARY production is considered small if it has Reporting and recordkeeping TREATMENTS average annual receipts of less than requirements, Transportation. I 4. The authority citation for part 305 $750,000. The 59 sweetpotato farms in 7 CFR Part 305 continues to read as follows: Hawaii accounted for annual sales of $989,000 in total in 2002. Therefore, it Irradiation, Phytosanitary treatment, Authority: 7 U.S.C. 7701–7772 and 7781– is likely that most of these farms would Plant diseases and pests, Quarantine, 7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, be considered small entities according Reporting and recordkeeping 2.80, and 371.3. requirements. to the SBA criteria. The monitoring and I 5. Section 305.2 is amended as inspection program will be mainly 7 CFR Part 318 follows: operated by APHIS personnel, and no Cotton, Cottonseeds, Fruits, Guam, I a. By revising paragraph (h)(1) to read impact is anticipated on other small Hawaii, Plant diseases and pests, Puerto as set forth below. I entities and government agencies. Rico, Quarantine, Transportation, b. In the table in paragraph (h)(2)(ii), Under these circumstances, the Vegetables, Virgin Islands. under Hawaii, by adding a new entry, in Administrator of the Animal and Plant alphabetical order, for ‘‘Banana’’ to read Health Inspection Service has 7 CFR Part 319 as set forth below. determined that this action will not Coffee, Cotton, Fruits, Imports, Logs, I c. In the table in paragraph (h)(2)(ii), have a significant economic impact on Nursery stock, Plant diseases and pests, under Hawaii, by removing the entry for a substantial number of small entities. Quarantine, Reporting and ‘‘’’ and adding in its place Executive Order 12372 recordkeeping requirements, Rice, a new entry for ‘‘Sweetpotato’’ to read Vegetables. as set forth below. This program/activity is listed in the I Catalog of Federal Domestic Assistance Accordingly, we are amending 7 CFR § 305.2 Approved treatments. under No. 10.025 and is subject to parts 301, 305, 318, and 319 as follows: * * * * * Executive Order 12372, which requires PART 301—DOMESTIC QUARANTINE (h) Fruits and vegetables. (1) intergovernmental consultation with NOTICES Treatment of fruits and vegetables from State and local officials. (See 7 CFR part foreign localities by irradiation in 3015, subpart V.) I 1. The authority citation for part 301 accordance with § 305.31 may be continues to read as follows: substituted for other approved Executive Order 12988 Authority: 7 U.S.C. 7701–7772 and 7781– treatments for any of the pests listed in This final rule has been reviewed 7786; 7 CFR 2.22, 2.80, and 371.3. § 305.31(a). Treatment of fruits and under Executive Order 12988, Civil Section 301.75–15 also issued under Sec. vegetables from Hawaii, Puerto Rico, Justice Reform. This rule: (1) Preempts 204, Title II, Pub. L. 106–113, 113 Stat. and the U.S. Virgin Islands by all State and local laws and regulations 1501A–293; sections 301.75–15 and 301.75– irradiation at the minimum doses listed that are inconsistent with this rule; (2) 16 also issued under Sec. 203, Title II, Pub. in § 305.31(a) and in accordance with has no retroactive effect; and (3) does L. 106–224, 114 Stat. 400 (7 U.S.C. 1421 § 305.34 may be substituted for other note). not require administrative proceedings approved treatments for any of the pests before parties may file suit in court I 2. In § 301.64–10, paragraph (g) listed in § 305.31(a). challenging this rule. introductory text and the OMB control (2) * * *

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(ii) * * *

Location Commodity Pest Treatment schedule

******* Hawaii

******* Banana ...... Bactrocera curcurbitae, Bactrocera dorsalis, IR. Ceratitis capitata, Coccus viridis.

******* Sweetpotato ...... Euscepes postfasciatus, Omphisa anastomosalis, MB T101–b–3–1 or § 305.24(k) or IR. Elytrotreinus or subtruncatus.

*******

* * * * * (4) After the core temperature of the adding the word ‘‘articles’’ in their I 6. In § 305.24, a new paragraph (k) is sweetpotato roots reaches 116.6 °F (47 place. ° added to read as follows: C), the core temperature must then be I e. In newly designated paragraph held at 116.6 °F (47 °C) or higher for 190 § 305.24 Vapor heat treatment schedules. (g)(3)(i)(A), footnote 3, and in paragraph minutes. (l), by removing the words ‘‘Inspection * * * * * I 7. Section 305.31 is amended as and’’ and adding the words ‘‘Science (k) Vapor heat treatment for follows: and’’ in their place and by removing the sweetpotatoes moved interstate from I a. By revising the section heading to words ‘‘1017 Main Campus Drive, suite Hawaii. (1) Temperature probes must be read as set forth below. 2500’’ and adding the words ‘‘1730 placed in the approximate center of the I b. By revising paragraph (a), including Varsity Drive, Suite 400’’ in their place. largest individual sweetpotato roots. the table, to read as set forth below. (2) The air surrounding the I c. By redesignating paragraph (g)(2) as The revisions and additions read as sweetpotato roots must be heated. After paragraph (g)(3) and adding a new follows: the temperature of the air surrounding paragraph (g)(2) to read as set forth ° § 305.31 Irradiation treatment of imported the sweetpotato roots reaches 87.8 F below. regulated articles for certain plant pests. (31 °C), its temperature must be I d. In paragraphs (b), (e)(1), (e)(2), incrementally raised from 87.8 °F (31 (f)(1)(i), (f)(1)(ii), (f)(1)(iii), (g) (a) Approved doses. Irradiation at the °C) to 111.2 °F (44 °C) over a period of introductory text, (g)(1), and (n), and in following doses for the specified plant 240 minutes. newly redesignated paragraphs (g)(3) pests, carried out in accordance with the (3) Using saturated water vapor at introductory text, (g)(3)(i) introductory provisions of this section, is approved 118.4 °F (48 °C), the core temperature of text, and (g)(3)(ii) introductory text, by as a treatment for all regulated articles the individual sweetpotato roots must removing the words ‘‘fruits and (i.e., fruits, vegetables, cut flowers, and be raised to 116.6 °F (47 °C). vegetables’’ each time they appear and foliage):

IRRADIATION FOR CERTAIN PLANT PESTS IN IMPORTED REGULATED ARTICLES1

Scientific name Common name Dose (gray)

Anastrepha ludens ...... Mexican fruit fly ...... 70 Anastrepha obliqua ...... West Indian fruit fly ...... 70 Anastrepha serpentina ...... Sapote fruit fly ...... 100 Anastrepha suspensa ...... Caribbean fruit fly ...... 70 Bactrocera jarvisi ...... Jarvis fruit fly ...... 100 Bactrocera tryoni ...... Queensland fruit fly ...... 100 Brevipalpus chilensis ...... False red spider mite ...... 300 Conotrachelus nenuphar ...... Plum curculio ...... 92 Croptophlebia ombrodelta ...... Litchi fruit moth ...... 250 Cryptophlebia illepida ...... Koa seedworm ...... 250 Cylas formicarius elegantulus ...... Sweetpotato weevil ...... 150 Cydia pomonella ...... Codling moth ...... 200 Euscepes postfasciatus ...... West Indian sweetpotato weevil ...... 150 Grapholita molesta ...... Oriental fruit moth ...... 200 Omphisa anastomosalis ...... Sweetpotato vine borer ...... 150 Rhagoletis pomonella ...... Apple maggot ...... 60 Sternochetus mangiferae (Fabricus) ...... Mango seed weevil ...... 300 Fruit flies of the family Tephritidae not listed above ...... 150 Plant pests of the class Insecta not listed above, except pupae and adults of the order Lepidoptera ...... 400 1 There is a possibility that some cut flowers could be damaged by such irradiation. See paragraph (n) of this section.

* * * * * (2) For all articles to be irradiated have no openings that will allow the (g) * * * upon arrival in the United States, the entry of fruit flies and that are sealed articles must be packed in cartons that with seals that will visually indicate if

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the cartons have been opened. They I e. In paragraph (b)(7)(i), by adding two (i) * * * In addition, sweetpotato may be constructed of any material that new sentences after the last sentence to from Hawaii to be treated with prevents the entry of fruit flies and read as set forth below. irradiation at a dose of 150 Gy must be prevents oviposition by fruit flies into I f. In paragraph (b)(7)(ii), by adding sampled, cut, and inspected in Hawaii the fruit in the carton. two new sentences after the last and found to be free of the ginger weevil * * * * * sentence to read as set forth below. (Elytrotreinus subtruncatus) by an I g. In paragraph (c), by removing the inspector before undergoing irradiation § 305.32 [Amended] words ‘‘1017 Main Campus Drive, suite treatment in Hawaii. Sampling, cutting, I 8. Section 305.32 is amended as 2500’’ and adding the words ‘‘1730 and inspection must be performed follows: Varsity Drive, Suite 400’’ in their place. under conditions that will prevent any I a. In paragraphs (a)(1) and (d), by I h. By revising the OMB control pests that may emerge from the sampled removing the words ‘‘a minimum number citation at the end of the section sweetpotatoes from infesting any other absorbed ionizing radiation dose of 150 to read as set forth below. sweetpotatoes intended for interstate Gray (15 krad)’’ and adding the words The revisions and additions read as movement in accordance with this ‘‘the approved dose for Mexican fruit fly follows: section. listed in § 305.31(a)’’ in their place. (ii) * * * In addition, sweetpotato I § 305.34 Irradiation treatment of certain b. In paragraph (e)(2), by removing the regulated articles from Hawaii, Puerto Rico, from Hawaii to be treated with words ‘‘150 Gray (15 krad)’’ and adding and the U.S. Virgin Islands. irradiation at a dose of 150 Gy must be the words ‘‘the approved dose for (a) Approved irradiation treatment. sampled, cut, and inspected in Hawaii Mexican fruit fly listed in § 305.31(a)’’ (1) Commodity-specific doses. and found to be free of the ginger weevil in their place. Irradiation, carried out in accordance (Elytrotreinus subtruncatus) by an I c. In paragraph (g), by removing the inspector. Sampling, cutting, and words ‘‘Oxford Plant Protection Center, with the provisions of this section, is approved as a treatment for the inspection must be performed under 901 Hillsboro St., Oxford, NC 27565’’ conditions that will prevent any pests and adding the words ‘‘Center for Plant following fruits and vegetables from Hawaii at the specified dose levels: that may emerge from the sampled Health Science and Technology, 1730 sweetpotatoes from infesting any other Varsity Drive, Suite 400, Raleigh, NC IRRADIATION FOR PLANT PESTS IN sweetpotatoes intended for interstate 27606’’ in their place. movement in accordance with this HAWAIIAN FRUITS AND VEGETABLES § 305.33 [Amended] section. I Commodity Dose (gray) * * * * * 9. Section 305.33 is amended as (Approved by the Office of Management and follows: Abiu ...... 150 Budget under control numbers 0579–0198 I a. In paragraphs (a)(1) and (d), by Atemoya ...... 150 and 0579–0281) removing the words ‘‘a minimum Bell pepper ...... 150 absorbed ionizing radiation dose of 225 Carambola ...... 150 PART 318—HAWAIIAN AND Gray (22.5 krad)’’ and adding the words Eggplant ...... 150 TERRITORIAL QUARANTINE NOTICES ‘‘the approved dose for Mediterranean Litchi1 ...... 150 fruit fly listed in § 305.31(a)’’ in their Longan ...... 150 I 11. The authority citation for part 318 place. Mango ...... 300 continues to read as follows: Papaya ...... 150 I b. In paragraph (e)(2), by removing the Authority: 7 U.S.C. 7701–7772 and 7781– Pineapple ...... 150 words ‘‘225 gray (22.5 krad)’’ and 7786; 7 CFR 2.22, 2.80, and 371.3. Rambutan ...... 150 adding the words ‘‘the approved dose Sapodilla ...... 150 § 318.13 [Amended] for Mediterranean fruit fly listed in Italian squash ...... 150 § 305.31(a)’’ in their place. Sweetpotato1 ...... 400 or 150 I 12. In § 318.13, paragraph (c) is I c. In paragraph (g), by removing the Tomato ...... 150 amended by removing the words words ‘‘Oxford Plant Protection Center, ‘‘leaves in full force and effect § 318.30 901 Hillsboro St., Oxford, NC 27565’’ (2) Pest-specific doses. Any articles which restricts the movement from and adding the words ‘‘Center for Plant from Puerto Rico or the U.S. Virgin Hawaii, Puerto Rico, or the Virgin Health Science and Technology, 1730 Islands, as well as any articles from Islands of the United States into or Varsity Drive, Suite 400, Raleigh, NC Hawaii not listed in paragraph (a)(1) of through any other State or certain 27606’’ in their place. this section, that are required by part Territories or Districts of the United I 10. Section 305.34 is amended as 318 of this chapter to be treated or States of all varieties of sweetpotatoes follows: subjected to inspection to control one or (Ipomoea batatas Poir.). It also’’. I a. By revising the section heading to more of the plant pests listed in I 13. Section 318.13–1 is amended as read as set forth below. § 305.31(a) may instead be treated with follows: I b. By revising paragraph (a), including irradiation. Articles treated with I a. In the definition of compliance the table, to read as set forth below. irradiation for plant pests listed in agreement, by removing the words I c. In paragraphs (b) introductory text, § 305.31(a) must be irradiated at the ‘‘§ 318.13–3(b), § 318.13–4(b), or (b)(1), (b)(2)(ii), and (b)(4), by adding the doses listed in § 305.31(a), and the § 318.13–4f of this subpart’’ and adding words ‘‘, Puerto Rico, or the U.S. Virgin irradiation treatment must be conducted the words ‘‘§ 318.13(b) or § 318.13–4(b) Islands’’ after the word ‘‘Hawaii’’ each in accordance with the other of this subpart or § 305.34 of this time it occurs. requirements of this section. chapter’’ in their place. I d. In paragraphs (b) introductory text, * * * * * I b. By revising the definition of (b)(1), (b)(2)(i), (b)(2)(ii), (b)(4)(i), (b) * * * inspector to read as set forth below. (b)(4)(ii), (b)(5), (b)(7)(i), (b)(7)(ii), and (7) * * * (e), by removing the words ‘‘fruits and § 318.13–1 Definitions. vegetables’’ each time they appear and 1 Litchi and sweetpotato are also subject to the * * * * * by adding the word ‘‘articles’’ in their additional inspection requirements in paragraph Inspector. Any individual authorized place. (b)(7) of this section. by the Administrator of APHIS or the

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Commissioner of Customs and Border v. Paragraph (e). (2) With net wrapping; or Protection, Department of Homeland vi. Paragraph (f). (3) With strapping so that each carton Security, to enforce the regulations in I b. In paragraph (b), by removing the on an outside row of the pallet load is this part. words ‘‘fruit flies’’ and adding the constrained by a metal or plastic strap. * * * * * words ‘‘plant pests’’ in their place. (C) Packaging must be labeled with I c. In paragraph (b), by adding the treatment lot numbers, packing and § 318.13–2 [Amended] word ‘‘sweetpotatoes,’’ after the word treatment facility identification and I 14. In § 318.13–2, in paragraph (b), the ‘‘rambutan,’’. location, and dates of packing and list of articles is amended by adding, in I 17. A new § 318.13–4d is added to treatment. alphabetical order, a new entry for read as follows: (ii) Cartons of untreated sweetpotatoes ‘‘Sweetpotato (Ipomoea batatas Poir.).’’ that are moving to the mainland United § 318.13–4d Vapor heat treatment of States for treatment must be shipped in I 15. Section 318.13–3 is amended as sweetpotatoes from Hawaii. shipping containers sealed prior to follows: (a) Vapor heat treatment, carried out interstate movement with seals that will I a. By revising paragraph (b)(3) to read in accordance with the provisions of visually indicate if the shipping as set forth below. this section, is approved as a treatment containers have been opened. I b. By adding a new paragraph (b)(4) to for sweetpotato from Hawaii. (5)(i) Certification on basis of read as set forth below. (b) Sweetpotatoes may be moved treatment. A certificate shall be issued § 318.13–3 Conditions of movement. interstate from Hawaii in accordance by an inspector for the movement of with this section only if the following * * * * * sweetpotatoes from Hawaii that have conditions are met: 2 (b) * * * been treated and handled in Hawaii in (1) The sweetpotatoes must be treated (3) Untreated regulated articles from accordance with this section. To be in accordance with the vapor heat Hawaii may be moved interstate for certified for interstate movement under treatment schedule specified in irradiation treatment on the mainland this section, sweetpotato from Hawaii § 305.24. United States if the provisions of must be sampled, cut, and inspected by (2) The sweetpotatoes must be § 305.34 of this chapter are met and if an inspector and found by an inspector sampled, cut, and inspected and found the articles are accompanied by a to be free of the ginger weevil to be free of the ginger weevil limited permit issued by an inspector in (Elytrotreinus subtruncatus) and (Elytrotreinus subtruncatus). Sampling, accordance with § 318.13–4(c). inspected and found by an inspector to cutting, and inspection must be Untreated bananas from Hawaii may be be free of the gray pineapple mealybug performed under conditions that will moved interstate for irradiation (Dysmicoccus neobrevipes), and the prevent any pests that may emerge from treatment on the mainland United States Kona coffee-root knot nematode the sampled sweetpotatoes from if the provisions of § 318.13–4i(b) are (Meloidogyne konaensis) before infesting any other sweetpotatoes met and if the bananas are accompanied undergoing vapor heat treatment in intended for interstate movement in by a limited permit issued by an Hawaii. accordance with this section. inspector in accordance with § 318.13– (ii) Limited permit. A limited permit (3) The sweetpotatoes must be shall be issued by an inspector for the 4(c). The limited permit will be issued inspected and found to be free of the only if the inspector examines the interstate movement of untreated gray pineapple mealybug (Dysmicoccus sweetpotato from Hawaii for treatment shipment and determines that the neobrevipes) and the Kona coffee-root shipment has been prepared in on the mainland United States in knot nematode (Meloidogyne accordance with this section. To be compliance with the provisions of this konaensis). subpart. eligible for a limited permit under this (4)(i) Sweetpotatoes that are treated in section, untreated sweetpotato from (4) Untreated sweetpotatoes from Hawaii must be packaged in the Hawaii may be moved interstate for Hawaii must be sampled, cut, and following manner: inspected in Hawaii by an inspector and vapor heat treatment on the mainland (A) The cartons must have no United States if the provisions of found by an inspector to be free of the openings that will allow the entry of ginger weevil (Elytrotreinus § 318.13–4d are met and if the fruit flies and must be sealed with seals sweetpotatoes are accompanied by a subtruncatus) and inspected and found that will visually indicate if the cartons by an inspector to be free of the gray limited permit issued by an inspector in have been opened. They may be accordance with § 318.13–4(c). The pineapple mealybug (Dysmicoccus constructed of any material that neobrevipes), and the Kona coffee-root limited permit will be issued only if the prevents the entry of fruit flies and inspector examines the shipment and knot nematode (Meloidogyne prevents oviposition by fruit flies into konaensis). determines that the shipment has been the fruit in the carton.3 prepared in compliance with the (B) The pallet-load of cartons must be (Approved by the Office of Management and provisions of this subpart. wrapped before it leaves the treatment Budget under control number 0579–0281) * * * * * facility in one of the following ways: I 18. Section 318.13–4f is revised to (1) With polyethylene sheet wrap; § 318.13–4b [Amended] read as follows:

I 16. Section 318.13–4b is amended as 2 Sweetpotatoes may also be moved interstate § 318.13–4f Irradiation treatment of certain follows: from Hawaii in accordance with § 305.34 of this regulated articles from Hawaii. I a. By adding the words ‘‘or chapter or after fumigation with methyl bromide Irradiation, carried out in accordance according to treatment schedule T–101–b–3–1, as vegetables’’ after the word ‘‘fruits’’ in provided for in § 305.6(a) of this chapter. with the provisions in § 305.34 of this the following places: 3 If there is a question as to the adequacy of a chapter, is approved as a treatment for i. The section heading. carton, send a request for approval of the carton, the following fruits and vegetables: ii. Paragraph (a). together with a sample carton, to the Animal and Abiu, atemoya, bell pepper, carambola, Plant Health Inspection Service, Plant Protection iii. Paragraph (b), in the paragraph and Quarantine, Center for Plant Health Science eggplant, litchi, longan, mango, papaya, heading and the first sentence. and Technology, 1730 Varsity Drive, Suite 400, pineapple, rambutan, sapodilla, Italian iv. Paragraph (c). Raleigh, NC 27606. squash, sweetpotato, and tomato. Any

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other commodities that are required by paragraph, bananas from Hawaii must § 318.58–4b Irradiation treatment of this subpart to be treated or subjected to be treated, inspected, and, if necessary, regulated articles from Puerto Rico and the inspection to control one or more of the culled in accordance with the U.S. Virgin Islands. plant pests listed in § 305.31(a) of this requirements of this paragraph prior to Any regulated articles from Puerto chapter may instead be treated with interstate movement from Hawaii. Rico or the U.S. Virgin Islands that are irradiation. Commodities treated with (ii) A limited permit shall be issued required by this subpart to be treated or irradiation for plant pests listed in by an inspector for the interstate subjected to inspection to control one or § 305.31(a) must be irradiated at the movement of untreated bananas from more of the plant pests listed in doses listed in § 305.31(a), and the Hawaii for treatment on the mainland § 305.31(a) of this chapter may instead irradiation treatment must be conducted United States in accordance with this be treated with irradiation. in accordance with the other section. To be eligible for a limited Commodities treated with irradiation for requirements of § 305.34. permit under this paragraph § 318.13– plant pests listed in § 305.31(a) must be I 19. Section 318.13–4i is amended as 4i(b), bananas from Hawaii must be irradiated at the doses listed in follows: inspected in accordance with the § 305.31(a), and the irradiation I a. By revising the section heading to requirements of this paragraph prior to treatment must be conducted in read as set forth below. interstate movement from Hawaii. accordance with the other requirements I b. By redesignating paragraphs (a), (b), of § 305.34. (c), and (d) as paragraphs (a)(1), (a)(2), § 318.13–5 [Amended] I 28. A new section § 318.58–4c is (a)(3), and (a)(4), respectively, and by I 20. In § 318.13–5, footnote 6 is added to read as follows. designating the introductory text of the redesignated as footnote 4. section as paragraph (a), introductory § 318.58–4c Movement of sweetpotatoes text. § 318.13–12 [Amended] from Puerto Rico to certain ports. I c. By adding a new paragraph (b) to I 21. In § 318.13–12, footnotes 7 and 8 Sweetpotatoes from Puerto Rico may read as set forth below. are redesignated as footnotes 5 and 6, be moved interstate to Atlantic Coast respectively. ports north of and including Baltimore, § 318.13–4i Conditions governing the MD, if the following conditions are met: movement of bananas from Hawaii. § 318.13–17 [Amended] (a) The sweetpotatoes must be * * * * * I 22. In § 318.13–17, footnotes 9 and 10 certified by an inspector of the (b) Bananas of any cultivar or ripeness Commonwealth of Puerto Rico as having that do not meet the conditions of are redesignated as footnotes 7 and 8, respectively. been grown under the following paragraph (a) of this section may also be conditions: moved interstate from Hawaii in Subpart—Sweetpotatoes [Removed] (1) Fields in which the sweetpotatoes accordance with the following have been grown must have been given conditions: I 23. Subpart—Sweetpotatoes, a preplanting treatment with an (1) The bananas are irradiated at the consisting of §§ 318.30 and 318.30a, is approved soil insecticide. minimum dose listed in § 305.31(a) of removed. (2) Before planting in such treated this chapter and in accordance with the fields, the sweetpotato draws and vine other requirements in § 305.34 of this § 318.58 [Amended] cuttings must have been dipped in an chapter for the Mediterranean fruit fly I 24. In § 318.58, paragraph (d) is approved insecticidal solution. (Ceratitis capitata), the melon fruit fly amended by removing the words (3) During the growing season an (Bactrocera curcurbitae), the Oriental ‘‘leaves in full force and effect § 318.30 approved insecticide must have been fruit fly (Bactrocera dorsalis), and the which restricts the movement from applied to the vines at prescribed green scale (Coccus viridis) and are Hawaii, Puerto Rico, or the Virgin intervals. inspected, after removal from the stalk, Islands of the United States into or (b) An inspector of the in Hawaii and found to be free of the through any other State or certain Commonwealth of Puerto Rico must banana moth (Opogona sacchari Territories or Districts of the United certify that the sweetpotatoes have been (Bojen)) by an inspector before or after States of all varieties of sweetpotatoes washed. undergoing irradiation treatment; or (Ipomoea batatas Poir.). It also’’. (c) The sweetpotatoes must be graded (2) The bananas are irradiated at the I by inspectors of the Commonwealth of minimum dose listed in §A305.31(a) of 25. In § 318.58–1, the definition of inspector is revised to read as follows: Puerto Rico in accordance with Puerto this chapter and in accordance with the Rican standards which do not provide a other requirements in § 305.34 of this § 318.58–1 Definitions. tolerance for insect infestation or chapter for the Mediterranean fruit fly * * * * * evidence of insect injury and found by (Ceratitis capitata), the melon fruit fly Inspector. Any individual authorized such inspectors to comply with such (Bactrocera curcurbitae), and the by the Administrator of APHIS or the standards prior to movement from Oriental fruit fly (Bactrocera dorsalis) Commissioner of Customs and Border Puerto Rico. and are inspected, after removal from Protection, Department of Homeland (d) The sweetpotatoes must be the stalk, in Hawaii and found to be free Security, to enforce the regulations in inspected by an inspector and found to of the green scale (Coccus viridis) and this part. be free of the sweetpotato scarabee the banana moth (Opogona sacchari (Euscepes postfasciatus Fairm.). (Bojen)) before or after undergoing * * * * * irradiation treatment. § 318.58–2 [Amended] PART 319—FOREIGN QUARANTINE (3)(i) A certificate shall be issued by NOTICES an inspector for the movement of I 26. In § 318.58–2, in paragraph (b)(2), bananas from Hawaii that have been the list of articles is amended by adding, I 29. The authority citation for part 319 treated and inspected in Hawaii in in alphabetical order, a new entry for continues to read as follows: accordance with this paragraph ‘‘Sweetpotato (Ipomoea batatas Poir.).’’ Authority: 7 U.S.C. 450, 7701–7772, and § 318.13–4i(b). To be certified for I 27. A new section § 318.58–4b is 7781–7786; 21 U.S.C. 136 and 136a; 7 CFR interstate movement under this added to read as follows: 2.22, 2.80, and 371.3.

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§ 319.56–2 [Amended] of the Federal Register as of February 2004, and published in the Federal I 30. In § 319.56–2, paragraph (k) is 27, 2006. Register on September 17, 2004 (69 FR amended by removing the words ‘‘11 FOR FURTHER INFORMATION CONTACT: 56101). A proposed rule to certify the species of fruit flies and one species of Lauren Quinones-Navarro or Jerry N. AP1000 was published on April 18, seed weevil’’ and adding the words Wilson, Office of Nuclear Reactor 2005 (70 FR 20062). ‘‘plant pests’’ in their place. Regulation, U.S. Nuclear Regulatory Subsequently, Westinghouse submitted editorial and minor technical I 31. Section 319.74–2 is amended as Commission, Washington, DC 20555– changes and clarifications to the follows by redesignating paragraph (d) 0001; telephone (301) 415–2007 or (301) inspections, tests, analyses, and as paragraph (e) and by adding a new 415–3145; e-mail: [email protected] or acceptance criteria (ITAAC) in revision paragraph (d) to read as follows: [email protected]. 15 to the design control document § 319.74–2 Conditions governing the entry SUPPLEMENTARY INFORMATION: (DCD). The NRC staff evaluated these of cut flowers. I. Background. changes in a supplement to the FSER * * * * * II. Comment Analysis (NUREG–1793, Supplement No. 1). (d) Irradiation. Cut flowers and foliage A. Design Control Document Supplement No. 1 is being made that are required under this part to be B. Design Certification Rule available to the public as part of this treated or subjected to inspection to III. Section-by-Section Analysis rulemaking. The FSER and Supplement A. Introduction (Section I) No. 1 provide the bases for the control one or more of the plant pests B. Definitions (Section II) listed in § 305.31(a) of this chapter may C. Scope and Contents (Section III) Commission’s approval of the AP1000 instead be treated with irradiation. D. Additional Requirements and standard plant design. An FDA, which Commodities treated with irradiation for Restrictions (Section IV) incorporates the changes to the DCD, plant pests listed in § 305.31(a) must be E. Applicable Regulations (Section V) will be issued to supersede the current irradiated at the doses listed in F. Issue Resolution (Section VI) FDA after issuance of this final design § 305.31(a), and the irradiation G. Duration of this Appendix (Section VII) certification rule. H. Processes for Changes and Departures treatment must be conducted in II. Comment Analysis accordance with the other requirements (Section VIII) I. Inspections, Tests, Analyses, and The period for submitting comments of § 305.34 of this chapter. There is a Acceptance Criteria (Section IX) possibility that some cut flowers could on the proposed DCR, AP1000 DCD, or J. Records and Reporting (Section X) draft environmental assessment (EA) be damaged by such irradiation. IV. Availability of Documents expired on July 5, 2005. The NRC * * * * * V. Voluntary Consensus Standards VI. Finding of No Significant Environmental received three letters from two private Done in Washington, DC, this 20th day of Impact: Availability citizens and one letter from the Nuclear January 2006. VII. Paperwork Reduction Act Statement Energy Institute (NEI). The comments Kevin Shea, VIII. Regulatory Analysis addressed three categories of Acting Administrator, Animal and Plant IX. Regulatory Flexibility Certification information: Environmental Assessment Health Inspection Service. X. Backfit Analysis (EA), Design Control Document, and [FR Doc. 06–746 Filed 1–26–06; 8:45 am] XI. Congressional Review Act Design Certification Rule. The responses BILLING CODE 3410–34–P I. Background to the comments on the EA are discussed in section 7.0 of the EA Subpart B of 10 CFR part 52 sets forth (ML053630176). Responses to the the process for obtaining standard NUCLEAR REGULATORY comments in the second and third design certifications. On March 28, 2002 COMMISSION categories are discussed below. (67 FR 20845; April 26, 2002), 10 CFR Part 52 Westinghouse tendered its application A. Design Control Document (DCD) for certification of the AP1000 standard Comment summary. There is an over- RIN 3150–AH56 plant design with the NRC. reliance on passive systems in the Westinghouse submitted this AP1000 Design Certification AP1000. application in accordance with subpart Response. The NRC disagrees with AGENCY: Nuclear Regulatory B and appendix O of 10 CFR part 52. this comment. The NRC required tests of Commission. The NRC formally accepted the the new passive safety systems to ACTION: Final rule. application as a docketed application demonstrate that they will perform as for design certification (Docket No. 52– predicted in the safety analysis (see SUMMARY: The Nuclear Regulatory 006) on June 25, 2002 (67 FR 43690; Chapter 21 of the AP1000 FSER). The Commission (NRC or Commission) is June 28, 2002). The pre-application NRC also required higher availability for amending its regulations to certify the information submitted before the NRC certain active backup systems to AP1000 standard plant design. This formally accepted the application can be compensate for any remaining action is necessary so that applicants or found in the NRC’s Agencywide uncertainties in the performance of the licensees intending to construct and Documents Access and Management passive safety systems (see Chapter 22 operate an AP1000 design may do so by System (ADAMS) under Docket Number of the AP1000 FSER). As a result of referencing this regulation [AP1000 PROJ0711 (Project No. 711). these reviews, the NRC concluded that design certification rule (DCR)]. The The NRC staff issued a final safety the use of passive safety systems in the applicant for certification of the AP1000 evaluation report (FSER) for the AP1000 AP1000 design is acceptable. design was Westinghouse Electric design in September 2004 (NUREG– Comment Summary. The AP1000 is Company, LLC (Westinghouse). 1793). The FSER provides the bases for an unnecessary and unsafe variation on DATES: Effective Date: The effective date issuance of a final design approval AP600. of this rule is February 27, 2006. The (FDA) under appendix O to part 52, Response. The NRC disagrees with the incorporation by reference of certain which is a prerequisite to a design comment. The NRC has determined that material specified in this regulation is certification. The FDA for the AP1000 the AP1000 design can be built and approved by the Director of the Office design was issued on September 13, operated safely (see AP1000 FSER). The

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