The imported fire ant regulations (contained in 7 CFR 301.81 through 301.81-10 and referred to below as the regulations) quarantine infested States or infested areas within States and restrict the interstate movement of regulated articles to prevent the artificial spread of the imported fire ant.

The imported fire ant (Solenopsis invicta Buren and Solenopsis richteri Forel) is an aggressive, stinging insect that, in large numbers, can seriously injure and even kill livestock, pets, and humans. The imported fire ant, which is not native to the United States, feeds on crops and builds large, hard mounds that damage farm and field machinery. The regulations are intended to prevent the imported fire ant from spreading throughout its ecological range within the country.

The regulations in § 301.81-3 provide that the Administrator of the Animal and Plant Health Inspection Service (APHIS) will list as a quarantined area each State, or each portion of a State, that is infested with the imported fire ant. The Administrator will designate less than an entire State as a quarantined area only under the following conditions: (1) The State has adopted and is enforcing restrictions on the intrastate movement of the regulated articles listed in § 301.81-2 that are equivalent to the interstate movement restrictions imposed by the regulations; and (2) designating less than the entire State will prevent the spread of the imported fire ant. The Administrator may include uninfested acreage within a quarantined area due to its proximity to an infestation or its inseparability from an infested locality for quarantine purposes.

In § 301.81-3, paragraph (e) lists quarantined areas. We are amending § 301.81-3(e) by:

• Revising the boundaries of the quarantined areas in Cherokee, Greenville, and Spartanburg Counties, SC, and changing the status of Anderson, Oconee, and Pickens Counties, SC, from partially to completely infested.

• Revising the boundaries of the quarantined areas in Maury County, TN, changing the status of Decatur, Franklin, and Monroe Counties, TN, from partially to completely infested, and adding portions of Bedford, Blount, Coffee, Grundy, and Loudon Counties, TN, to the list of quarantined areas.

We are taking these actions because recent surveys conducted by APHIS and State and county agencies revealed that the imported fire ant has spread to these areas. See the rule portion of this document for specific descriptions of the new and revised quarantined areas.

This rulemaking is necessary on an emergency basis to prevent the spread of imported fire ant into noninfested areas of the United States. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the Federal Register.

We will consider comments we receive during the comment period for this interim rule (see DATES above). After the comment period closes, we will publish another document in the Federal Register. The document will include a discussion of any comments we receive and any amendments we are making to the rule.

This rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This interim rule is necessary because infestations of imported fire ant have been discovered in additional areas of South Carolina and Tennessee. This action will establish quarantined areas in 5 new counties and revise the boundaries of the quarantined areas in 10 other counties in those States. As a result of this action, the interstate movement of regulated articles from those areas is restricted. This action is necessary to prevent the artificial spread of the imported fire ant into noninfested areas of the United States.

The following analysis addresses the economic effects of this rule and the impact on small entities as required by the Regulatory Flexibility Act.

The market value of the agricultural products sold in the 15 counties affected by this rule was more than $445 million, according to the 1997 Agricultural Census. This represents 12 percent of the combined total value of agricultural sales for both States.

Potential damage by imported fire ant presents a risk to the agricultural economies in these 15 counties. During 1997, the value of sales from nursery and greenhouse crops in these 15 counties were at minimum $54 million. Those entities potentially affected by this action include nurseries, greenhouses, farm equipment dealers, construction companies, and those entities that sell, process, or move regulated articles interstate from and through quarantined areas. These economic entities are now required to treat and certify their regulated articles before moving them interstate.

According to the Small Business Administration (SBA) definition, a small agricultural producer is one having less than $750,000 in annual sales, and a small equipment dealer or a small agricultural service company is one generating less than $5 million in annual sales.

According to this definition, all of the estimated 433 potentially affected entities in the counties affected by this rule are considered small by SBA standards. However, both the number of affected entities and the scope of the economic effects resulting from this action are dependent on any given entity's proportion of sales outside the quarantined area.

The adverse economic effect on these entities can be substantially minimized by the availability of various treatment options that will allow for the movement of regulated articles from the quarantined area with only a small additional cost. The treatment cost for a standard shipment of nursery plants is estimated to be between $116 and $200, which represents, at most, 2 percent of the value of a standard tractor-trailer load of nursery plants ($10,000 to $250,000). The benefits of this action are substantial, both ensuring continued agricultural sales from the affected counties and preventing human-assisted spread of imported fire ant.

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.

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 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.

This interim rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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 irradiation 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.1 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,2 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 variables 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.

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.

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).3 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.

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).

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 bell 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.

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.

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.

The regulations in “Subpart—Hawaiian Fruits and Vegetables” (7 CFR 318.13 through 318.13-17, referred to below as the regulations) govern, among other things, the interstate movement of fruits, vegetables, and other products, including cut flowers, from Hawaii. Regulation is necessary to prevent the spread of plant pests that exist in Hawaii.

The regulations in § 318.13-3(b)(1) provide that cut flowers (except cut blooms of gardenia, mauna loa, and jade vine, and leis thereof) may be moved interstate under certain conditions and if accompanied by a limited permit. The movement of cut blooms of gardenia has been prohibited due to gardenia's status as a host of green scale (Coccus viridus), also known as green coffee scale.

On May 15, 2002, we published in the Federal Register (67 FR 34626-34630, Docket No. 01-042-1) a proposal to amend the regulations to provide for the interstate movement of gardenia from Hawaii. As described in the proposed rule, cut blooms of gardenia from Hawaii would be eligible for movement to other parts of the United States if they were treated with irradiation in Hawaii or grown in accordance with certain prescribed conditions.

We solicited comments concerning our proposal for 60 days ending July 15, 2002. We received a total of four comments by that date. They were from growers, researchers, and private citizens. Three commenters strongly supported the proposal, agreeing that specific growing and inspection protocols or irradiation treatment will effectively mitigate the plant pest risks associated with green scale and facilitate interstate movement of gardenia blooms from Hawaii.

The remaining commenter stated that existing data concerning irradiation dosage rates for the treatment of gardenias for green scale are insufficient to support the effectiveness of the treatment described in the proposed rule. As a result of that comment, we reevaluated the proposed irradiation treatment option and found that the recommended 250 gray dosage likely is insufficient, since the data indicate that complete mortality of all green scales on gardenia treated at the proposed 250 gray dosage only occurs after 20 weeks. A higher dosage would be preferable, but testing has demonstrated that gardenias do not tolerate such a dose without unacceptable decline in quality. Consequently, we have concluded that the irradiation treatment described in the proposed rule would be an unacceptable treatment for quarantine purposes. Based on that conclusion, we have omitted treatment with irradiation from this final rule as an option for qualifying cut blooms of gardenia for interstate movement from Hawaii. We will continue to examine the irradiation treatment option and, if appropriate, amend the provisions for interstate movement of gardenias in the future.

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 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.

In this document, we are amending the regulations to provide for the movement of cut blooms of gardenia from Hawaii. We have determined that specific growing and inspection protocols can effectively mitigate the plant pest risks associated with gardenia grown in Hawaii. This action provides for the interstate movement of gardenias from Hawaii while continuing to prevent the spread of plant pests within the United States.

Under this rule, gardenia growers in Hawaii who wish to move cut blooms of gardenia interstate from Hawaii would be able to do so if the gardenias were produced in a growing area determined by an inspector to be free of green scale and to meet other requirements and if the cut blooms were inspected and found free of green scale prior to interstate movement.

According to the USDA's Pacific Basin Agricultural Research Center in Hawaii, the total planted area of gardenias in Hawaii is 26.6 acres. Of the 26.6 acres of gardenias, only 3.6 acres belong to commercial farms: 2 acres in Kona, on the island of Hawaii; 1.1 acres in the Manoa Valley (Oahu); and 0.5 acres in Waipahu (Oahu). The remaining 23 acres of planted gardenias in Hawaii are owned by approximately 100 growers, each having an average of 20 to 25 bushes or about 10,000 square feet of production area. These gardenias are grown in “backyard” type production conditions.

The largest commercial gardenia production area in Hawaii consists of 2 acres of planted gardenia bushes that produce about 69,200 flowers per year, with annual gross receipts from sales of just under $13,000. While sales figures are not available for the two smaller commercial producers, we presume that their annual sales are less than those of the largest producer.

According to Small Business Administration size standards, an entity involved in floriculture production (NAICS code 111422) is considered a small entity if it has annual sales of less than $750,000. Under this definition, all commercial gardenia growers in Hawaii would be considered small entities.

Under the Regulatory Flexibility Act, agencies are required to specifically consider the economic effects of their rules on small entities. The entities most likely to be affected by this rule are the commercial producers of gardenias discussed previously in this analysis; the producers are all considered to be small entities.

We expect that commercial gardenia producers will benefit from the ability to move their products interstate to markets in the continental United States while incurring the costs associated with establishing and maintaining a green-scale-free growing area. While we cannot estimate the amount of additional sales that might be enjoyed by commercial gardenia producers as a result of this rule, we do not expect that amount will be substantial, given the limited scale of commercial gardenia production in Hawaii. The costs associated with the production area requirements are likely to be negligible and limited to the maintenance of a 20-foot-host-plant-free buffer zone around the production area, as the required inspections will be provided free of charge.

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.

This program/activity is listed in the Catalogue 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.

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 0579-0197.

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.

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of specified animals and animal products into the United States in order to prevent the introduction of various animal diseases, including foot-and-mouth disease (FMD). Because of the highly communicable nature of FMD, it is necessary to protect livestock that are free of the disease from any animals, animal products, or other articles that might be contaminated with the FMD virus.

In an interim rule effective March 31, 2001, and published in the Federal Register on May 13, 2002 (67 FR 31935-31938, Docket No. 01-037-1), we amended the regulations to prohibit the importation of used farm equipment from regions affected with FMD unless the equipment was steam-cleaned prior to export to the United States so that it is free of exposed dirt and other particulate matter. Such equipment must also be accompanied by an original certificate signed by an authorized official of the national animal health service of the country of origin stating that such cleaning was done. We also provided that cleaned equipment that arrives at a U.S. port with the required certification from the exporting region but is found upon Animal and Plant Health Inspection Service (APHIS) inspection to contain a minimal amount of exposed dirt or other particulate matter may be cleaned at the port of arrival should the APHIS inspector determine that there are adequate facilities and personnel at the port to conduct such cleaning without the risk of disease contamination.

Comments on the interim rule were required to be received on or before July 12, 2002. We received two comments by that date, from a farmer and a representative of a dairy industry organization. Both commenters supported the interim rule but requested that additional steps be taken to prevent the introduction of FMD into the United States. One commenter asked APHIS to ensure that dirt or other particulate matter trapped in large tires on farm equipment would be adequately cleaned. We believe that the cleaning and inspection requirements established by the interim rule will be adequate to ensure that any such residue will be eliminated.

The second commenter supported the requirement for pre-export steam cleaning, but suggested that if an APHIS inspector notes exposed dirt on the equipment at the port of arrival and determines that the equipment can be cleaned, APHIS should require not only that the equipment be steam-cleaned but disinfected as well, using an approved disinfectant. The interim rule provides that all used farm equipment imported into the United States must be steam-cleaned free of all exposed dirt and other particulate matter. If such equipment were to arrive at the port of entry with more than a minimal amount of exposed soil present, it would be clear to an inspector that the required cleaning was not properly conducted and the equipment would be denied entry. The inspector may only allow cleaning at the port of entry if the amount of exposed soil is minimal enough to allow cleaning and there are adequate facilities and personnel at the port to accomplish the cleaning. Thus any cleaning that might take place at a port of entry would be necessary to address the presence of only minimal amounts of exposed soil. Steam-cleaning, whether conducted in the equipment's country of origin or at a U.S. port, is sufficient to disinfect the equipment. Therefore, we do not believe that it is necessary to prescribe the use of a disinfectant in addition to the cleaning that would be conducted.

Therefore, for the reasons given in the interim rule and in this document, we are adopting the interim rule as a final rule without change.

This action also affirms the information contained in the interim rule concerning Executive Orders 12866 and 12988 and the Paperwork Reduction Act.

Further, this action 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.

This rule affirms an interim rule that amended the regulations by prohibiting the importation of used farm equipment from regions affected with FMD unless the equipment is steam-cleaned prior to export to the United States so that it is free of exposed dirt and other particulate matter and the equipment is accompanied by an original certificate from an authorized official of the national animal health service of the region of origin stating that such cleaning was done. The interim rule also provided that cleaned equipment that arrives at the port of arrival with a minimal amount of exposed dirt may, under certain conditions, be cleaned at the port of arrival.

The following analysis addresses the economic effect of the interim rule on small entities, as required by the Regulatory Flexibility Act.

While the term “farm equipment,” as defined in § 94.0 of the regulations, refers to a variety of vehicles and machinery used in agriculture, tractors are the one category of farm equipment for which trade data are maintained on previously used items.1 Between 1996 and 2001, U.S. imports of used tractors were valued at about $62 million annually, and comprised about 4 percent of the value of all U.S. agricultural tractor imports (table 1). U.S. exports of used tractors were worth a little more than half that amount, about $34 million per year. Net imports of used tractors were thus worth about $28 million per year, about 10 percent of the value of net imports of tractors.2

In May 2002, a Boeing Model 747-200 series airplane was involved in an in-flight breakup. A portion of the fuselage skin with a repair doubler attached was recovered, and investigation revealed that the repair doubler was installed after a tail strike that occurred in 1980 and caused scratches to the skin. Examination of the skin underneath the doubler revealed longitudinal scratches, which could have been caused by the tail strike event, and a 15-inch crack found underneath the repair doubler that originated from and extended along these scratches. Further investigation of the affected area revealed that certain damage (scratches) may not have been found and removed after the tail strike, which led to fatigue cracking over time. The probable cause of the accident has not yet been determined.

The FAA recently received a second report indicating that scratches were found under a repair doubler on a Model 747-200 series airplane during an inspection requested by the manufacturer. It has been determined that the aft “belly” portion of the section 46 fuselage on Model 747 series airplanes is susceptible to tail strike damage during landing and takeoff. Repair procedures in the Boeing 747 structural repair manual describe blending out such damage on the skin and installing a repair doubler over the affected area. Any unremoved damage could result in fatigue cracking of the fuselage skin concealed under certain repair doublers, and consequent rapid decompression of the airplane.

The FAA has reviewed and approved Boeing Alert Service Bulletin 747-53A2489, dated November 26, 2002, which describes procedures for a one-time external visual inspection of the fuselage skin at body stations 1961 through 2360 inclusive, between stringers S-46L and S-46R, for repair doublers. If a repair doubler is installed, and the repair doubler meets all four criteria (external repair doubler, at least 8 inches long longitudinally (in the forward and aft direction), has fasteners common to a frame, and was installed due to a tail strike or for unknown reasons) specified in Figure 2 of the service bulletin, the service bulletin describes procedures for follow-on inspections and corrective actions.

The follow-on inspections and corrective actions include removal of the doubler, a one-time assessment (inspection) of the skin under the doubler for damage (scratches, cracking), and repair of any damage found. For certain airplanes, as an alternative to removal of the doubler and assessment of the skin underneath, the service bulletin describes procedures for repetitive inspections of the fuselage skin for damage. These inspections are either internal mid-frequency eddy current, or external detailed visual, depending on the length of the doubler. Accomplishment of the actions specified in the service bulletin is intended to adequately address the identified unsafe condition.

The service bulletin also specifies contacting Boeing for disposition of certain repair conditions.

Since an unsafe condition has been identified that is likely to exist or develop on other 747 series airplanes of the same type design, this AD is being issued to find and fix possible fatigue cracking of the fuselage skin concealed under certain repair doublers, which could result in rapid decompression of the airplane. This AD requires a one-time inspection of the fuselage skin of the aft lower body for repair doublers, and follow-on inspections and corrective actions if repair doublers are installed. This AD also includes optional repetitive inspections of the fuselage skin for scratches or cracking. The actions are required to be accomplished in accordance with the service bulletin described previously, except as discussed below.

The service bulletin specifies an inspection of the fuselage skin between stringers S-46L and S-46R for the presence of doublers. However, the FAA has determined that repairs common to the S-46 lap splice that do not extend inboard more than 4 inches from the S-46 center line do not require the inspection. Tail strike damage would more likely occur towards the “belly” portion of the section 46 fuselage. Repairs limited to the S-46 lap splice area are probably due to corrosion findings. The manufacturer agrees with this determination and will incorporate this change into the next revision of Boeing Alert Service Bulletin 747-53A2489.

The service bulletin also specifies that the manufacturer may be contacted for disposition of certain repair conditions, but this AD would require the repair of those conditions to be accomplished in accordance with a method approved by the FAA, or in accordance with data meeting the type certification basis of the airplane approved by a Boeing Company Designated Engineering Representative who has been authorized by the FAA to make such findings.

This is considered to be interim action. The FAA is currently considering further rulemaking action to revise the compliance time of this AD to include airplanes that have accumulated more than 10,000 total flight cycles, but less than 15,000 total flight cycles; however, the planned compliance time for the additional airplanes is sufficiently long so that notice and opportunity for prior public comment will be practicable.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-316-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

On January 16, 2003, the FAA issued emergency AD 2003-02-51, which is applicable to all Bombardier Model CL-600-2C10 (Regional Jet Series 700 and 701) series airplanes.

Transport Canada Civil Aviation (TCCA), which is the airworthiness authority for Canada, advises that vibration and fuel line misalignment in the center tank has resulted in damage to fuel line couplings and cracks in the fuel feed lines. TCCA also advises that more recently four incidents have been reported of cracked fuel feed lines near the welded boss for the transfer ejector motive flow lines within the center fuel tank. The airplanes landed without incident. As a result of the fuel leakage into the center tank, an imbalance of fuel could occur within the fuel system and a significant amount of fuel may not be usable during flight. Discrepancies in the fuel distribution system, if not detected and corrected, could cause the center tank to overfill and fuel to leak from the center tank vent system or to become inaccessible, and could result in engine fuel starvation.

Bombardier has issued Canadair Temporary Revision (TR) RJ 700/42, dated January 14, 2003, which describes procedures for revising the Limitations, Normal Procedures, and Abnormal Procedures sections of the Airplane Flight Manual (AFM) to introduce new quantity limitations for the center fuel tank and associated procedures. TCCA classified this TR as mandatory and issued Canadian airworthiness directive CF-2003-01, dated January 15, 2003, in order to ensure the continued airworthiness of these airplanes in Canada.

This airplane model is manufactured in Canada and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, TCCA has kept the FAA informed of the situation described above. The FAA has examined the findings of TCCA, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

On May 7, 2002, the FAA issued AD 2002-08-19, amendment 39-12731 (67 FR 31939, May 13, 2002), applicable to all Bombardier Model CL-600-2C10 (Regional Jet Series 700 and 701) series airplanes. That AD requires revising the AFM to address uncommanded transfer of fuel between the wing fuel tanks and the center fuel tank; revising the Minimum Equipment List (MEL); limiting airplane operation; and increasing normal mission fuel requirements by 3,000 pounds. That AD also requires modification of the fuel distribution system for the center tank; an inspection of the system for discrepancies; and corrective actions if necessary.

This AD, however, addresses a newly identified failure mode in the fuel transfer system involving fuel leaks in the aft section of the center fuel tank, while the failure mode discussed in AD 2002-08-19 involves fuel leaks in the forward section of the center fuel tank.

Since the unsafe condition described is likely to exist or develop on other airplanes of the same type design registered in the United States, the FAA issued emergency AD 2003-02-51 to detect and correct discrepancies in the fuel distribution system, which could cause the center tank to overfill and fuel to leak from the center tank vent system or to become inaccessible, and could result in engine fuel starvation. The AD requires an AFM revision to introduce new quantity limitations for the center fuel tank and associated procedures; to limit flight to within 30 minutes of a suitable alternative airport; and to limit the center tank fuel quantity to 1,500 lbs. (680 kgs.) maximum at takeoff. This AD terminates certain requirements of AD 2002-08-19.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual notices issued on January 16, 2003, to all known U.S. owners and operators of Bombardier Model CL-600-2C10 (Regional Jet Series 700 and 701) series airplanes. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective as to all persons.

This is considered to be interim action until final action is identified, at which time the FAA may consider further rulemaking.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2003-NM-20-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and that it is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Dornier Model 328-100 and -300 series airplanes was published in the Federal Register on September 25, 2002 (67 FR 60193). That action proposed to require replacement of the screws in the aileron, rudder, and elevator trim tabs with new screws; and removal and re-installation of screws in the aileron, elevator, and rudder trim tabs and the rudder spring tab; as applicable.

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were submitted in response to the proposal or the FAA's determination of the cost to the public.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 53 Model 328-100 series airplanes and 48 Model 328-300 series airplanes of U.S. registry will be affected by this AD, that it will take approximately 3 work hours per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will be supplied by the manufacturer at no cost to operators. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $18,180, or $180 per airplane.

The cost impact figure discussed above is based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

The Direction Generale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, notified the FAA that an unsafe condition may exist on certain Airbus Model A330-223, -321, -322, and -323 series airplanes equipped with Pratt & Whitney Model PW4164, PW4168, or PW4168A engines. The DGAC advises that engine fan blade-out tests performed by the engine manufacturer, Pratt &Whitney, have shown that the loads used for certification of the engines were underestimated. In the event of an engine fan blade-out, the induced loads could lead to reduced structural integrity of the primary structure of the engine pylons, and uncommanded deployment of the thrust reversers. This condition, if not corrected, could result in reduced controllability of the airplane.

Airbus has issued Service Bulletin A330-54-3016, Revision 01, dated August 7, 2000, which describes procedures for the modification of the primary structure of the engine pylons. The modification includes, among other actions, replacing the stainless steel screws at rib 8B and rib 12 with Inconel screws, and replacing the stainless steel screws located on the lateral panel seam of the lower spar between rib 8C and rib 10 with stainless steel screws of the next-higher-nominal diameter.

Airbus has also issued Service Bulletin A330-78-3011, dated December 14, 1999, which describes procedures for the replacement of the thrust reverser locking actuators with new, improved locking actuators.

Accomplishment of the actions specified in these service bulletins is intended to adequately address the identified unsafe condition. The DGAC classified these service bulletins as mandatory and issued French airworthiness directive 2000-237-123(B) R1, dated December 12, 2001, in order to assure the continued airworthiness of these airplanes in France.

Airbus Service Bulletin A330-78-3011, dated December 14, 1999, references Pratt & Whitney Service Bulletin PW4G-100-78-71, dated September 24, 1999, as an additional source of service information for accomplishment of the replacement of the thrust reverser locking actuators.

This airplane model is manufactured in France and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.19) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design that may be registered in the United States at some time in the future, this AD is being issued to prevent the reduced structural integrity of the primary structure of the engine pylons, and uncommanded deployment of the thrust reversers, which could result in reduced controllability of the airplane. This AD requires accomplishment of the actions specified in the service bulletins described previously, except as discussed below.

This AD differs from the parallel French airworthiness directive in that it will not require repetitive visual inspections of the fan blades at intervals not to exceed 500 engine hours, or an ultrasonic inspection of the attachment area of the fan blade root before the accumulation of 5,000 parts cycles since new, or within 500 parts cycles after the effective date of the French airworthiness directive. These inspections are not associated with any known unsafe condition. The DGAC required these inspections to minimize the possibility of a fan blade-off event, pending the retrofit of the modifications in paragraph 3 of the French airworthiness directive. All Airbus Model A330-223, -321, -322, and -323 series airplanes of U.S. registry were delivered with the modifications installed.

The French airworthiness directive defers implementation of the mandatory actions (i.e., modification of the engine pylon and replacement of the thrust reverser locking actuators) for a period of time by requiring the inspections described in the preceding paragraph. The compliance time for accomplishment of the mandatory actions is before the accumulation of 8,000 flight cycles since new, or before August 1, 2004, whichever occurs first. The DGAC advises that if the inspections in the preceding paragraph are not mandated, the modifications must be accomplished in a timeframe comparable to that of the inspections. Therefore, this AD requires accomplishment of the mandatory actions within 500 engine hours or six months after the effective date of this AD, whichever occurs later.

Operators should note that, unlike the French airworthiness directive, this AD will not require the replacement of the pylon aft mount nuts and bolts since the manufacturer has confirmed to the FAA that all pylon aft mount nuts and bolts made of MP159 material have already been replaced. Additionally, the French airworthiness directive requires replacement of the pylon front mount bolts made of MP159 material. The FAA has determined through review of data provided by the engine manufacturer that repetitive inspection of front mount bolts made of MP159 material addresses the unsafe condition. As discussed below, the FAA previously issued two other ADs that require these actions.

These differences have been coordinated with and acknowledged by the DGAC.

The FAA has previously issued two other ADs that concern the pylon aft and forward mount nuts and bolts on Airbus airplanes:

1. AD 2000-25-53, amendment 39-12051 (65 FR 82259, December 28, 2000), requires repetitive inspections for cracks or other damage of pylon aft mount nuts and bolts made of MP159 material.

2. AD 2000-16-02, amendment 39-11856 (65 FR 49730, August 15, 2000), requires repetitive inspections and torque checks for loose or broken pylon forward mount bolts made from INCO 718 material and establishes a new life limit for these bolts. The AD also requires repetitive inspections of pylon forward mount bolts made from MP159 material.

However, this AD will not affect the current requirements of either of those previously issued ADs.

The FAA estimates that 9 airplanes of U.S. registry will be affected by this AD. The FAA has been advised that the 9 affected airplanes have been modified in accordance with the requirements of this AD. Therefore, currently, this AD action imposes no additional economic burden on any U.S. operator.

However, should an unmodified airplane be imported and placed on the U.S. Register in the future, it will take approximately 51 work hours per airplane to accomplish the actions, at an average labor rate of $60 per work hour. Required parts will be supplied by the manufacturer to the operators at no cost. Based on these figures, the cost impact of the AD is estimated to be $3,060 per airplane.

Since this AD action does not affect any airplane that is currently on the U.S. registry, it has no adverse economic impact and imposes no additional burden on any person. Therefore, prior notice and public procedures hereon are unnecessary and the amendment may be made effective in less than 30 days after publication in the Federal Register.

Although this action is in the form of a final rule and was not preceded by notice and opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications shall identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Submit comments using the following format:

• Organize comments issue-by-issue. For example, discuss a request to change the compliance time and a request to change the service bulletin reference as two separate issues.

• For each issue, state what specific change to the proposed AD is being requested.

• Include justification (e.g., reasons or data) for each request.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NM-102-AD.” The postcard will be date stamped and returned to the commenter.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

What events have caused this AD? The Ente Nazionale per l' Aviazione Civile (ENAC), which is the airworthiness authority for Italy, recently notified FAA that an unsafe condition may exist on all Piaggio Model P-180 airplanes. The ENAC reports an incident of a ground fire on the left-hand engine nacelle of one of the affected airplanes. Investigation revealed that the fire was caused by a cracked crossfeed valve that had leaked fuel.

Further analysis led the ENAC to determine that the part number (P/N) EM484-3 valve was part of a manufacturing batch of nonconforming valves. This batch incorporates serial numbers 148 through 302 of these P/N EM484-3 valves. These valves can be utilized as either firewall shutoff or crossfeed valves.

What is the potential impact if FAA took no action? If these valves are not removed from service, they could develop cracks and leak fuel. This could result in an engine fire.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all Piaggio Model P-180 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on November 13, 2002 (67 FR 68782). The NPRM proposed to require you to inspect and determine whether any firewall shutoff or crossfeed valve with a serial number in a certain range is installed and would require you to replace any valve that has a serial number within this range. The NPRM would allow the pilot to check the logbook and would not require the inspection and replacement requirements if the check showed that one of these valves was definitely not installed.

Was the public invited to comment? The FAA encouraged interested persons to participate in the making of this amendment. We did not receive any comments on the proposed rule or on our determination of the cost to the public.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We have determined that these minor corrections:

• Provide the intent that was proposed in the NPRM for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM.

How many airplanes does this AD impact? We estimate that this AD affects 22 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the inspection:

We estimate the following costs to accomplish the replacement/modification:

What will be the compliance time of this AD? The inspection compliance time of this AD is “within the next 30 days after the effective date of the AD.”

Why is the compliance time presented in calendar time instead of hours time-in-service (TIS)? The compliance of this AD is presented in calendar time instead of hours TIS because the affected shutoff and crossfeed valves are unsafe as a result of a quality control problem. The problem has the same chance of existing on an airplane with 50 hours TIS as it would for an airplane with 1,000 hours TIS. Therefore, we believe that a compliance time of 30 days will:

• Ensure that the unsafe condition does not go undetected for a long period of time on the affected airplanes; and

• Not inadvertently ground any of the affected airplanes.

Does this AD impact various entities? The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

Does this AD involve a significant rule or regulatory action? For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

Transport Canada, which is the airworthiness authority for Canada, recently notified the FAA that an unsafe condition may exist on PWC PW530A, PW535A, and PW545A turbofan engines. Transport Canada has advised the FAA that there have been five reports of fuel dripping from the engine nacelle. It was found that the dripping fuel was the result of leaking flexible fuel tubes. Transport Canada advises that certain P/N's of the flexible fuel tube, located between the fuel/oil heat exchanger and the integral fuel control unit-fuel pump, may leak due to possible manufacturing defects in the tube.

PWC has issued Service Bulletin (SB) PW500-72-30217, Revision 1, dated July 29, 2002, that specifies procedures for performing a one-time visual inspection of flexible fuel tubes P/N's 30J2285-01 (PW530A engines), 3054416-01 (PW535A engines), and 30J2323-01 (PW545A engines). The tubes must be inspected externally for leaks, local swelling, sponginess of the red silicone rubber, gashes, gouges, and tears, and internally for kinks, gouging, or loose material in the tube bore. Tubes that pass inspection are then re-marked with a new P/N. In lieu of the tube inspection, the SB also allows for replacement of the flexible fuel tube with a different P/N tube. Transport Canada issued AD CF-2002-42, dated September 30, 2002, in order to assure the airworthiness of these PWC PW500 series turbofan engines in Canada.

This engine model is manufactured in Canada and is type certificated for operation in the United States under the provisions of section 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, Transport Canada has kept the FAA informed of the situation described above. The FAA has examined the findings of Transport Canada, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other Pratt & Whitney Canada PW530A, PW535A, and PW545A turbofan engines of the same type design, this AD is being issued to prevent a fire in the engine nacelle. This AD requires the following within 50 flight hours, but no later than 60 days after the effective date of this AD, whichever occurs first:

• Replacement of flexible fuel tubes P/N's 30J2285-01 (PW530A engines), 3054416-01 (PW535A engines), and 30J2323-01 (PW545A engines) with flexible fuel tubes P/N's 30J2578-01, 3058704-01, and 30J2579-01 respectively; or

• A one-time visual external and internal inspection of flexible fuel tubes P/N's 30J2285-01, 3054416-01, and 30J2323-01; and

• Part number re-marking of flexible fuel tubes that pass inspection. The actions must be done in accordance with the service bulletin described previously.

Since a situation exists that requires the immediate adoption of this regulation, it is found that notice and opportunity for prior public comment hereon are impracticable, and that good cause exists for making this amendment effective in less than 30 days.

Although this action is in the form of a final rule that involves requirements affecting flight safety and, thus, was not preceded by notice and an opportunity for public comment, comments are invited on this rule. Interested persons are invited to comment on this rule by submitting such written data, views, or arguments as they may desire. Communications should identify the Rules Docket number and be submitted in triplicate to the address specified under the caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

Comments are specifically invited on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. All comments submitted will be available, both before and after the closing date for comments, in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this action must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2002-NE-45-AD.” The postcard will be date stamped and returned to the commenter.

This final rule does not have federalism implications, as defined in Executive Order 13132, because it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the FAA has not consulted with state authorities prior to publication of this final rule.

The FAA has determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and is not a “significant regulatory action” under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket. A copy of it, if filed, may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes was published in the Federal Register on November 15, 2002 (67 FR 69157). That action proposed to require installing speedbrake limitation placards in the flight compartment, and revising the Limitations Section of the Airplane Flight Manual (AFM) to ensure the flightcrew is advised not to extend the speedbrake lever beyond the flight detent. For certain airplanes, that action also proposed to require modifying the elevator and elevator tab assembly.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comments received. One commenter concurs with the proposed AD. Two commenters state that they have no comments on the proposed AD.

One commenter asks that certain language, as specified in paragraph (a)(2) of the proposed AD, be clarified. The commenter notes that the current language, which is to be included in the AFM, states the following: “Do not extend the speedbrake lever beyond the flight detent in flight.” That statement, as written, does not match the language specified in the existing AFM. The language should be changed, for clarification, to match the AFM language and should state: “In flight, do not extend the speedbrake lever beyond the FLIGHT detent.”

The FAA agrees with the commenter in that the language used in paragraph (a)(2) of the AD should be clarified to match the AFM language. We have changed paragraph (a)(2) of this final rule accordingly.

The same commenter asks that the Discussion section of the proposed AD be changed to remove the reference to Boeing Model 737-900 series airplanes from the first sentence. That sentence states, “The FAA has received several reports of excessive in-flight vibrations of the elevator and elevator tab on certain Boeing Model 737-600, -700, -700C, -800, and -900 series airplanes.” The commenter notes that no excessive in-flight vibrations of the elevator and elevator tab have occurred on Model 737-900 series airplanes.

The same commenter asks that certain terminology in the Discussion section of the proposed AD be changed. That section reads, in part, “[t]he elevator and elevator tab are susceptible to excessive vibration and, under certain conditions, limit-cycle flutter. These vibration events have been attributed to loose or missing components, excessive wear, or excessive freeplay of the tab.” The commenter requests that it be changed to, “[t]he elevator and elevator tab are susceptible to excessive vibration and, under certain conditions, limit-cycle oscillation (LCO). These vibration events have been attributed to lack of torsional rigidity (in the case of LCO); or missing components, excessive wear, or excessive freeplay of the tab.” The commenter states that LCO is the accepted and proper term to use when referring to the severe vibrations associated with lack of torsional stiffness.

We acknowledge that no excessive in-flight vibrations of the elevator and elevator tab have been reported on Model 737-900 series airplanes in-service. The intent of the Discussion section is to provide the background and events that prompted the proposed AD, and to specify that vibrations did occur on Model 737-600, -700, -700C, and -800 series airplanes in-service.

We acknowledge that the term “lack of torsional rigidity” is a valid term and could be used to describe a design deficiency that also contributes to excessive in-flight vibration. However, the terms “LCO” and “LCF” are not commonly used terms in the airline industry; these terms are used primarily by airplane manufacturers. We have concluded that the term “high amplitude oscillations of the elevator tab” best describes the condition in a manner understood by the airline industry.

Since the Discussion section of a proposed AD is not restated in a final rule, no change to this final rule is necessary to address the issues raised by the commenters.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule with the change previously described. The FAA has determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are approximately 1,174 airplanes of the affected design in the worldwide fleet. We estimate that 550 airplanes of U.S. registry will be affected by this AD.

It will take approximately 1 work hour per airplane to accomplish the required placard installation, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the required installation on U.S. operators is estimated to be $33,000, or $60 per airplane.

It will take approximately 1 work hour per airplane to accomplish the required AFM revision, at an average labor rate of $60 per work hour. Based on these figures, the cost impact of the required revision on U.S. operators is estimated to be $33,000, or $60 per airplane.

It will take approximately 88 work hours per airplane to accomplish the required modification of the elevator and elevator tab assembly, at an average labor rate of $60 per work hour. The FAA has been advised by Boeing that the manufacturer will provide parts for the elevator/tab retrofit, including shipping, at no cost to operators. The manufacturer will have operators “exchange” their existing parts for new parts to support the retrofit program. Based on this information, the cost impact of the required modification on U.S. operators is estimated to be $2,904,000, or $5,280 per airplane.

The cost impact figures discussed above are based on assumptions that no operator has yet accomplished any of the requirements of this AD action, and that no operator would accomplish those actions in the future if this AD were not adopted. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions.

The regulations adopted herein will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, it is determined that this final rule does not have federalism implications under Executive Order 13132.

For the reasons discussed above, I certify that this action (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and (3) will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. A final evaluation has been prepared for this action and it is contained in the Rules Docket. A copy of it may be obtained from the Rules Docket at the location provided under the caption ADDRESSES.

Recent ground testing and a review of the rigging procedures of a Raytheon Beech Model 1900D airplane reveals that the elevator control system could be mis-rigged to restrict elevator travel if current maintenance procedures are not properly followed. In these instances, it may appear to the crew that they have full elevator control column movement. However, the elevator may not have full travel. Such restricted travel may remain undetected until the airplane is operated in a loading condition that requires full elevator authority to control the pitch.

The Raytheon Beech Models 1900 and 1900C airplanes incorporate the same elevator control system design and are affected by this condition.

In certain loading conditions, a mis-rigged elevator control system, if not detected and corrected, could lead to insufficient elevator control authority and loss of control of the airplane.

Raytheon has not issued service information regarding this subject. Rigging procedures are included in the applicable Raytheon 1900/1900C or 1900D maintenance manual.

On January 27, 2003, FAA issued emergency AD 2003-03-18 to require you to:

—Perform control column sweep and stop bolt inspections to verify full elevator travel to the primary up and down stops and to verify that the stop bolt length is not excessive;

—If the airplane does not pass the initial control column sweep and stop bolt inspections, re-rig and/or do a more detailed inspection of the elevator control system;

—If the airplane does pass the initial control column sweep and stop bolt length inspections, do a more detailed inspection within 100 hours time-in-service (TIS); and

—Report the results of the initial inspection and the 100-hour TIS inspection (if applicable).

The FAA found that immediate corrective action was required, that notice and opportunity for prior public comment were impracticable and contrary to the public interest, and that good cause existed to make the AD effective immediately by individual letters issued on January 27, 2003, to all known U.S. operators of Raytheon Beech Models 1900, 1900C, and 1900D airplanes. These conditions still exist, and the AD is published in the Federal Register as an amendment to section 39.13 of the Federal Aviation Regulations (14 CFR 39.13) to make it effective to all persons.

Although this action is in the form of a final rule and was not preceded by notice and opportunity for public comment, FAA invites your comments on the rule. You may submit whatever written data, views, or arguments you choose. You need to include the rule's docket number and submit your comments to the address specified under the caption ADDRESSES. We will consider all comments received on or before the closing date specified above. We may amend this rule in light of comments received. Factual information that supports your ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether we need to take additional rulemaking action.

We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of the rule that might suggest a need to modify the rule. You may view all comments we receive before and after the closing date of the rule in the Rules Docket. We will file a report in the Rules Docket that summarizes each FAA contact with the public that concerns the substantive parts of this AD.

If you want us to acknowledge the receipt of your written comments, you must include a self-addressed, stamped postcard. On the postcard, write “Comments to Docket No. 2003-CE-07-AD.” We will date stamp and mail the postcard back to you.

These regulations will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, FAA has determined that this final rule does not have federalism implications under Executive Order 13132.

We have determined that this regulation is an emergency regulation that must be issued immediately to correct an unsafe condition in aircraft, and is not a significant regulatory action under Executive Order 12866. It has been determined further that this action involves an emergency regulation under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979). If it is determined that this emergency regulation otherwise would be significant under DOT Regulatory Policies and Procedures, a final regulatory evaluation will be prepared and placed in the Rules Docket (otherwise, an evaluation is not required). A copy of it, if filed, may be obtained from the Rules Docket.

The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Public Law 101-629), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA) (Public Law 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under the 1976 amendments, class II devices were defined as devices for which there is insufficient information to show that general controls themselves will assure safety and effectiveness, but for which there is sufficient information to establish performance standards to provide such assurance. The SMDA broadened the definition of class II devices to mean devices for which there is insufficient information to show that general controls themselves will assure safety and effectiveness, but for which there is sufficient information to establish special controls to provide such assurance, including performance standards, postmarket surveillance, patient registries, development and dissemination of guidance, recommendations, and any other appropriate actions the agency deems necessary (section 513(a)(1)(B) of the act).

Under section 513 of the act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 amendments), generally referred to as preamendments devices, are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the act) into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval, unless and until: (1) The device is reclassified into class I or II; (2) FDA issues an order classifying the device into class I or II in accordance with new section 513(f)(2) of the act, as amended by the FDAMA; or (3) FDA issues an order finding the device to be substantially equivalent, under section 513(i) of the act, to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to previously offered devices by means of premarket notification procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).

A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application (PMA) until FDA issues a final regulation under section 515(b) of the act (21 U.S.C. 360e(b)) requiring premarket approval.

Reclassification of postamendments devices is governed by section 513(f)(3) of the act, formerly section 513(f)(2) of the act. This section provides that FDA may initiate the reclassification of a device classified into class III under section 513(f)(1) of the act, or the manufacturer or importer of a device may petition the Secretary of Health and Human Services (the Secretary) for the issuance of an order classifying the device in class I or class II. FDA's regulations in § 860.134 (21 CFR 860.134) set forth the procedures for the filing and review of a petition for reclassification of such class III devices. In order to change the classification of the device, it is necessary that the proposed new class have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.

The FDAMA added a new section 513(f)(2) to the act which addresses classification of postamendments devices. New section 513(f)(2) of the act provides that, upon receipt of a “not substantially equivalent” determination, a 510(k) applicant may request FDA to classify a postamendments device into class I or class II. Within 60 days from the date of such a written request, FDA must classify the device by written order. If FDA classifies the device into class I or II, the applicant has then received clearance to market the device and it can be used as a predicate device for other 510(k)s. It is expected that this process will be used for low risk devices. This process does not apply to devices that have been classified by regulation into class III, i.e., preamendments class III devices, or class III devices for which a PMA is appropriate.

Under section 513(f)(3)(B)(i) of the act, formerly section 513(f)(2)(B)(i) of the act, the Secretary may, for good cause shown, refer a petition to a device classification panel. If a petition is referred to a panel, the panel shall make a recommendation to the Secretary respecting approval or denial of the petition. Any such recommendation shall contain: (1) A summary of the reasons for the recommendation, (2) a summary of the data upon which the recommendation is based, and (3) an identification of the risks to health (if any) presented by the device with respect to which the petition was filed.

On July 2, 1997, FDA filed the reclassification petition submitted by BioMerieux Vitek, Inc., requesting reclassification of the fully automated short-term incubation cycle antimicrobial susceptibility devices from class III to class II. FDA consulted with the Microbiology Devices Panel (the panel). During an open public meeting on February 13, 1998, the panel unanimously recommended that FDA reclassify the fully automated short-term incubation cycle antimicrobial susceptibility device for use in determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens from class III to class II. The panel identified the risks to health regarding use of this device as the reporting of erroneous results, citing that insufficient testing of each unique antimicrobial agent with an inappropriate clinical and challenge organism, the use of an uncalibrated inoculum, or a nonstandardized acceptable error endpoint can result in such erroneous reports.

FDA considered the panel's recommendations and tentatively agreed that the generic type of device, the fully automated short-term incubation cycle antimicrobial susceptibility device for use in determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens, be reclassified from class III to class II. Subsequently, in the Federal Register of March 8, 2000 (65 FR 12268), FDA issued a notice of the panel's recommendation for public comment.

After reviewing the information in the petition and presenting it before the panel, and after considering the panel's recommendation and the comments received in response to the notice of panel recommendation, FDA issued an order to the petitioner on December 28, 2001, reclassifying the fully automated short-term incubation cycle antimicrobial susceptibility device and substantially equivalent devices of this generic type, from class III to class II with the implementation of special controls. The special control applicable to this generic type of device is a guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.” FDA has identified the administration of an inappropriate antimicrobial agent to the patient as the risk to health associated with use of this device. The guidance document contains sections that discuss the use of appropriate challenge strains; standardized preparation of inoculum; the application of “acceptable error” as a range with confidence intervals; and appropriate clinical performance testing. In this way, the guidance will minimize the sources of erroneous reporting associated with the fully automated short-term incubation cycle antimicrobial susceptibility device. Testing and labeling recommendations are also discussed in the guidance document and also help manufacturers address the risk to health. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a fully automated short-term incubation cycle antimicrobial susceptibility device will need to address the issues covered in the special control guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

Accordingly, as required by § 860.134(b)(6) and (b)(7) of the regulations, FDA is announcing the reclassification of the fully automated short-term incubation cycle antimicrobial susceptibility device from class III into class II. FDA is codifying the reclassification and the special control guidance by adding new § 866.1645. For the convenience of the reader, FDA is also adding a new § 866.1(e) to inform the reader where to find guidance documents referenced in 21 CFR part 866.

The agency has determined under 21 CFR 25.34(b) that this reclassification is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the notice under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety and other advantages, distributive impacts, and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive order. In addition, the final rule is not a significant regulatory action as defined by the Executive order and so is not subject to review under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of the device from class III to class II will relieve all manufacturers of the device of the cost of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace by lowering their costs. The agency therefore certifies that this rule will not have a significant economic impact on a substantial number of small entities. In addition, this rule will not impose costs of $110 million or more on either the private sector or State, local, and tribal governments in the aggregate, and therefore a summary statement or analysis pursuant to section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS HOWARD (DDG 83) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 3(a) pertaining to the location of the forward masthead light in the forward quarter of the vessel, and the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS PREBLE (DDG 88) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 3(a) pertaining to the location of the forward masthead light in the forward quarter of the vessel, and the horizontal distance between the forward and after masthead lights; Annex I, paragraph 3(c), pertaining to placement of task lights not less than two meters from the fore and aft centerline of the ship in the athwartship direction; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; and Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS MUSTIN (DDG 89) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 3(a) pertaining to the location of the forward masthead light in the forward quarter of the vessel, and the horizontal distance between the forward and after masthead lights; Annex I, paragraph 3(c), pertaining to placement of task lights not less than two meters from the fore and aft centerline of the ship in the athwartship direction; Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions; and Annex I, paragraph 2(f)(ii), pertaining to the vertical placement of task lights. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS BULKELEY (DDG 84) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 3(a) pertaining to the location of the forward masthead light in the forward quarter of the vessel, and the horizontal distance between the forward and after masthead lights; and Annex I, paragraph 2(f)(i), pertaining to the placement of the masthead light or lights above and clear of all other lights and obstructions. The Deputy Assistant Judge Advocate General (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

Pursuant to the authority granted in 33 U.S.C. 1605, the Department of the Navy amends 32 CFR Part 706. This amendment provides notice that the Deputy Assistant Judge Advocate General of the Navy (Admiralty and Maritime Law), under authority delegated by the Secretary of the Navy, has certified that USS MASON (DDG 87) is a vessel of the Navy which, due to its special construction and purpose, cannot fully comply with the following specific provisions of 72 COLREGS without interfering with its special function as a naval ship: Annex I, paragraph 2(f)(i) pertaining to placement of the masthead light or lights above and clear of all other lights and obstructions, Annex I paragraph 2(f)(ii) pertaining to the vertical placement of the task lights, Annex I paragraph 3(a) pertaining to the location of the forward masthead light in the forward quarter of the vessel, and the horizontal distance between the forward and after masthead lights, and Annex I paragraph 3(c) pertaining to the horizontal placement of the task lights. The Deputy Assistant Judge Advocate General of the Navy (Admiralty and Maritime Law) has also certified that the lights involved are located in closest possible compliance with the applicable 72 COLREGS requirements.

Moreover, it has been determined, in accordance with 32 CFR Parts 296 and 701, that publication of this amendment for public comment prior to adoption is impracticable, unnecessary, and contrary to public interest since it is based on technical findings that the placement of lights on this vessel in a manner differently from that prescribed herein will adversely affect the vessel's ability to perform its military functions.

The NJTRO railroad bridge has a vertical clearance in the closed position of 3 feet at mean high water and 8 feet at mean low water. The existing drawbridge operation regulations are listed at 33 CFR 117.709(b).

The bridge owner, New Jersey Transit Rail Operations, requested a temporary deviation from the drawbridge operation regulations to facilitate necessary maintenance, the refurbishment of the electrical controls, at the bridge. The bridge must remain in the closed position to perform these repairs. Vessels that can pass under the bridge without a bridge opening may do so at all times.

The waterway users who normally navigate Cheesequake Creek are predominantly recreational vessels. The proposed time period is historically the time period during which the fewest requests are made to open the bridge. The Coast Guard coordinated this closure with the mariners who normally use this waterway to help facilitate this necessary bridge repair and to minimize any disruption to the marine transportation system.

Under this temporary deviation the NJTRO railroad bridge may remain closed to vessel traffic from 8 a.m. on February 3, 2003, through 4 p.m. on February 16, 2003. The bridge shall open upon a four-hour advance notice for emergency situations.

This deviation from the operating regulations is authorized under 33 CFR 117.35, and will be performed with all due speed in order to return the bridge to normal operation as soon as possible.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b) (B), the Coast Guard finds that good cause exists for not publishing an NPRM. Publishing an NPRM, which would incorporate a comment period before a final rule was issued, would be contrary to the public interest since immediate action is needed to prevent destruction, loss or injury to resources involved in the military operations taking place in the vicinity of the Norfolk International Terminals.

A security zone is being established encompassing the grounds, piers and waterside of Norfolk International Terminals, Norfolk, Virginia from 5 a.m. January 28, 2003 until 11:59 p.m. February 4, 2003. This zone is needed to safeguard materials and persons in the vicinity from sabotage or other subversive acts, accidents, or other causes of a similar nature while military operations are being conducted. This security zone will encompass the Virginia Port Authority property known as Norfolk International Terminals, at 7737 Hampton Blvd, Norfolk, Virginia, 23505, including all property that is enclosed by the perimeter fence. The security zone will also include the waters of the Elizabeth River in proximity to Norfolk International Terminals, as bounded by a line extending westerly from the shoreline at position 36°−56.001′ North latitude, 76°−19.726′ West longitude to a point at 36°−55.996′ North latitude, 76°−20.152′ West longitude, thence southerly to a point at 36°−54.762′ North latitude, 76°−20.244′ West longitude, then southeasterly to a point at 36°−53.854′ North latitude, 76°−20.093′ West longitude, then to the shoreline at position 36°−54.216′ North latitude, 76°−19.481′ West longitude. The security zone will be enforced from 5 a.m. January 28, 2003 until 11:59 p.m. February 4, 2003. U.S. Coast Guard personnel will be on scene at all times while the security zone is in effect. U.S. Coast Guard vessels will enforce the security zone over the water whenever a vessel involved in the military operation is inside the security zone. Commercial and recreational boats will not be permitted to enter the security zone, except as permitted by the Captain of the Port.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979).

Although this regulation restricts access to the regulated area, the effect of this regulation will not be significant because: (i) The COTP may authorize access to the security zone; (ii) the security zone will be in effect for a limited duration; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” include small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. section 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit or anchor within the security zone established at Norfolk International Terminals, from 5 a.m. January 28, 2003 until 11:59 p.m. February 4, 2003.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding this rule.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not affect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. It has not been designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

We have considered the environmental impact of this rule and concluded that under Figure 2-1, Paragraph (34)(g), of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. This rule is less than one week in duration.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

• Antimicrobial pesticides (NAICS 32561)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2002-0308. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of March 28, 2002 (67 FR 14948) (FRL-6828-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 2G6378) by Valent BioSciences Corporation, 870 Technology Way, Suite 100, Libertyville, IL 60048. This notice included a summary of the petition prepared by the petitioner Valent BioSciences Corporation. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended to expand the existing tolerance exemption by establishing a temporary exemption from the requirement of a tolerance for residues of 6-benzyladenine.

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider available information concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The toxicological profile for 6-benzyladenine has been previously published by the Agency in the N6-Benzyladenine (synonymous with the subject active ingredient, 6-benzyladenine) Reregistration Eligibility Decision (RED) document of June 1994 (Ref. 1). The summarized values and categories for the various studies for the technical active ingredient are presented here.

1. Acute toxicity. Toxicity Category III was assigned to the acute oral toxicity study in the rat (LD50 = 1.3 grams/kilogram (g/kg)), and in the eye irritation study in the rabbit (moderate irritant). Toxicity Category IV was assigned to the acute dermal toxicity study in the rabbit (LD50 > 5 g/kg), the acute inhalation toxicity study in the rat (LC50 = 5.2 milligrams/liter (mg/L)), and in the dermal irritation study in the rabbit (slight irritant). Additionally, from a dermal sensitization study in the guinea pig, it was determined that N6-benzyladenine is not a dermal sensitizer.

2. Genotoxicity. From three mutagenicity studies (Ames test, mouse micronucleus assay, and unscheduled DNA synthesis assay in the rat), it was determined that N6-benzyladenine is not mutagenic.

3. Developmental toxicity. The no observed adverse effect levels (NOAEL) and the lowest observed adverse effect levels (LOAEL) for maternal and developmental toxicity in rats, respectively, were found to be 50 and 175 mg/kg of body weight (bwt)/day, respectively.

4. Subchronic toxicity. For rats of both sexes, the NOAEL was approximately 111 mg/kg of bwt/day and the LOAEL was approximately 304 mg/kg of bwt/day.

In examining aggregate exposure, section 408 of the FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food. Apple and pistachio field trials performed in support of the temporary tolerance exemption request and the associated experimental use permit yielded acceptable magnitude of the residue data (Ref. 2). Residues were below the limit of quantitation (LOQ) for pistachios treated with a total of 60 g of active ingredient (a.i.) per acre. In apples, residues of 6-benzyladenine were consistently near the LOQ. However, residues did not increase in processed commodities (relative to the levels on the raw commodity), and were below the LOQ. Thus, the apple field data are adequate to support the temporary tolerance exemption petition and experimental program to apply ≤182 grams of active ingredient per acre per season. Also, because application precedes harvest by 2 months for pistachio and by approximately 2.5 months for apple, the potential for dietary exposure is reduced.

Due to the low anticipated dietary intake of 6-benzyladenine residues relative to the chronic and acute population adjusted doses (see Unit VI, below), and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was based on worst-case assumptions, it is highly unlikely that the proposed new uses of 6-benzyladenine on apples and pistachios will result in adverse effects to human health.

2. Drinking water exposure. The proposed uses on apples and pistachios are not expected to add potential exposure to drinking water. Soil leaching studies have suggested that 6-benzyladenine is relatively immobile (Ref. 3), absorbing to sediment. Residues reaching surface waters from field runoff should quickly absorb to sediment particles and be partitioned from the water column. 6-Benzyladenine also has low solubility in water, 76 ± 2 mg/L at 20° C (Ref. 2), and detections in ground water are not expected. Together, these data indicate that residues are not expected in drinking water.

The potential for non-dietary exposure to 6-benzyladenine residues for the general population, including infants and children, is unlikely because the uses are limited to experimental applications in apple and pistachio orchards. Because 6-benzyladenine is a naturally occurring cytokinin plant regulator (Ref. 4, 5, 6, 7, and 8), it is a normal part of the human diet. The proposed experimental use rates are well below the toxicity NOAELs. The residues indicate dietary exposures that are 0.03% and 0.01% of the chronic and acute population adjusted doses, respectively. Therefore, while there exists a great likelihood of prior exposure for most, if not all, individuals to 6-benzyladenine, any increased exposure due to the proposed experimental product would be negligible due to the lack of residue in comparison with the toxicity NOAELs.

The Agency has considered the cumulative effects of 6-benzyladenine and other substances in relation to a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Based on the available information and data for 6-benzyladenine, no mammalian toxicity is expected at the proposed experimental use rates. Therefore, no cumulative effects are expected.

1. U. S. population. The analysis estimated that the chronic exposures for the overall U.S. population was 0.000014 mg/kg/day (0.03% of the chronic population adjusted dose (cPAD)). The acute dietary estimated exposure was 0.000069 mg/kg/day (0.01% of the acute population adjusted dose (aPAD)) for the overall U.S. population. Critical exposure commodity analysis showed that apple juice contributed the most to dietary exposure for the overall population. Due to the low anticipated dietary intake of 6-benzyladenine residues relative to the chronic and acute population adjusted doses, and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was made based on worst-case assumptions, it is likely that the proposed new uses of 6-benzyladenine on apples and pistachios will not result in adverse effects to human health.

2. Infants and children. The analysis estimated that the chronic exposures for the most highly exposed subgroup, non-nursing infants, was 0.000085 mg/kg/day (0.2% of the cPAD). The acute dietary estimated exposure was 0.000361 mg/kg/day (0.07% of aPAD) for the most highly exposed subgroup, non-nursing infants. Critical exposure commodity analysis showed that apple juice contributed the most to dietary exposure for all infants. Due to the low anticipated dietary intake of 6-benzyladenine residues relative to the chronic and acute PAD, and the fact that actual exposure will probably be considerably less because the dietary exposure analysis was made based on worst-case assumptions, it is likely that the proposed new uses of 6-benzyladenine on apples and pistachios will not result in adverse effects to human health.

EPA is required under the FFDCA as amended by FQPA to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, 6-benzyladenine may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

Based on available data, no endocrine system-related effects have been identified with consumption of 6-benzyladenine. To date, there is no evidence to suggest that 6-benzyladenine affects the immune system, functions in a manner similar to any known hormone, or that it acts as an endocrine disruptor.

The Agency is establishing a temporary exemption from the requirement of a tolerance for the reasons stated above. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purposes for 6-benzyladenine.

Currently, there are no Codex, Canadian or Mexican maximum residue levels for residues of 6-benzyladenine in/on apples or pistachios.

Based on the toxicology information submitted and reviewed previously, and summarized in the June 1994 N6-Benzyladenine RED (Ref. 1), there is a reasonable certainty that no harm will result from aggregate exposure of residues of 6-benzyladenine to the U.S. population, including infants and children, under reasonably foreseeable circumstances, when the biochemical pesticide is used in accordance with good agricultural practices under the conditions of the 2-year experimental program. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the data submitted previously and summarized in the RED, as well as that data submitted to support the temporary tolerance exemption and Experimental Use Permit applications, demonstrating negligible dietary exposure in comparison with the toxicity NOAELs. As a result, EPA establishes a temporary exemption from the tolerance requirements pursuant to FFDCA 408(c) and (d) for residues of 6-benzyladenine in or on apples and pistachios.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0308 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 7, 2003.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2002-0308, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

1. U.S. EPA, Reregistration Eligibility Decision (RED) N6-Benzyladenine, June 1994.

2. U.S. EPA; Memorandum; R. S. Jones to D. Greenway; October 2, 2002.

3. Weigand, R., et al, Metabolism and Movement of N-[Phenylmethyl]-1H-Purin-6-Amine in Soils, 1976. Unpublished study received January 13, 1977 for EPA Registration Number 275-32; submitted by Abbott Laboratories, North Chicago, IL; CDL:095728-C.

4. Nandi, S. K., et al, Identification of cytokinins in primary crown gall tumours of tomato, Plant Cell and Environment (1989) 12:273-283.

5. Pechova, D., et al, Identification of new aromatic cytokinins in plants, 17th International Conference on Plant Growth Substances, July 1-6, 2001.

6. Strnad, M., et al, Immunodectection and identification of N6-(o-hydroxybenzylamino) purine as a naturally occurring cytokinin in Populus x canadensis Moench cv Robusta leaves, Plant Physiol. (1992) 99:74-80.

7. Strnad, M., Enzyme immunoassays of N6-benzyladenine and N6-(meta-hydroxybenzyl)adenine cytokinins, J Plant Growth Regul. (1996) 15:179-188.

8. Van Staden, J. and N. R. Crouch, Benzyladenine and derivatives-their significance and interconversion in plants, Plant Growth Regulation (1996) 19:153-175.

This final rule establishes an exemption from the tolerance requirement under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule ” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS Code 111)

• Animal production (NAICS Code 112)

• Food manufacturing (NAICS Code 311)

• Pesticide manufacturing (NAICS Code 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2002-0344. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of May 1, 2002 ( 67 FR 21671)(FRL-6833-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP 2E6359, 2E6365, 2E6377 and 2E6393) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petitions prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.532 be amended by establishing tolerances for residues of the fungicide cyprodinil, 4-cyclopropyl- 6-methyl- N-phenyl-2-pyrimidinamine, in or on the caneberry subgroup at 10.0 parts per million (ppm) (2E6393), watercress at 20 ppm (2E6365), pistachio at 0.07 ppm (2E6377) and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm (2E6359). IR-4 subsequently revised the petition to propose the following tolerances for cyprodinil residues in or on the caneberry subgroup at 10.0 parts per million (ppm), watercress at 20 ppm, pistachio at 0.10 ppm and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of cyprodinil on the caneberry subgroup at 10.0 parts per million (ppm), watercress at 20 ppm, pistachio at 0.10 ppm and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by cyprodinil are discussed in Table 1 of this unit as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effectlevel (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences.

For dietary risk assessment (other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose (acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF (RfD = NOAEL/UF). Where an additional safety factor (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

For non-dietary risk assessments (other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF (10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and compared to the LOC.

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10-6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOEcancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for cyprodinil used for human risk assessment is shown in Table 2 of this unit:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.352) for the residues of cyprodinil, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from cyprodinil in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA insert 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% crop treated (PCT) and tolerance-level residues for cyprodinil on all treated crops. This assessment was a Tier I analysis. However, the only acute endpoint identified was for the population subgroup females 13-50 years old based on a slight increase of litters showing extra ribs (13th). No effects that could be attributed to a single exposure were observed (no end point was chosen) for any other population subgroup, including the general U.S. population; therefore, an acute dietary assessment for the general U.S. population or other subgroups was not conducted.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM®) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: 100% crop treated (PCT) and tolerance-level residues for cyprodinil on all treated crops. This assessment was a Tier I analysis.

2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for cyprodinil in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of cyprodinil.

The Agency uses the Generic Estimated Environmental Concentration (GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) to estimate pesticide concentrations in surface water and SCI-GROW, which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) for a screening-level assessment for surface water. The GENEEC model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

None of these models include consideration of the impact processing (mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a percent of reference dose or percent of population adjusted dose. Instead, drinking water levels of comparison (DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to cyprodinil they are further discussed in the aggregate risk sections below.

Based on the PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of cyprodinil for acute exposures are estimated to be 32 parts per billion (ppb) for surface water and 0.04 ppb for ground water. The EECs for chronic exposures are estimated to be 6 ppb for surface water and 0.04 ppb for ground water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Cyprodinil is not registered for use on any sites that would result in residential exposure.

4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA does not have, at this time, available data to determine whether cyprodinil has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, cyprodinil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that cyprodinil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

1.In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of rat or rabbit fetuses followingin utero exposure in the developmental studies with cyprodinil. There is no evidence of increased susceptibility of young rats in the reproduction study with cyprodinil.

3. Conclusion. With the exception of missing 21/28-day dermal- toxicity and 28-day inhalation-toxicity studies in rats, there is a complete toxicity data base for cyprodinil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Since there are no residential uses for cyprodinil the only exposure route to infants and children is the oral route, for which the toxicity and exposure data base is complete. Therefore dermal and inhalation-toxicity studies, are not needed to assess risk to infants and children and EPA determined that the 10X safety factor to protect infants and children should be reduced to 1X.

The FQPA 10X safety factor is removed because:

• i. There are currently no registered or proposed residential(non-occupational) uses of cyprodinil.

• ii. There was no evidence (qualitative or quantitative) of increased susceptibility in the developmental rat or rabbit study following in utero exposure or in the two-generation reproduction study following pre- or post-natal exposure.

• iii. There was also no evidence of a neurodevelopmental effect in the rat or rabbit developmental toxicity studies or in the rat two-generation reproductive-toxicity study.

• iv. There are no data deficiencies for pre- and/or post-natal exposure and hence there are no residual uncertainties.

• v. Food and drinking water exposure assessments will not underestimate the potential exposure for all populations, including infants and children.

To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water (EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure (i.e., the PAD) is available for exposure through drinking water [e.g., allowable chronic water exposure (mg/kg/day) = cPAD - (average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC.

A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA are used to calculate DWLOCs: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening-level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short-term, intermediate-term, chronic, and cancer.

When EECs for surface water and groundwater are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to cyprodinil will occupy <1% of the aPAD for the subpopulation females 13-50 years old, the only population for whom an effect attributable to an acute exposure could be observed. In addition, there is potential for acute dietary exposure to cyprodinil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit:

2. Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to cyprodinil from food will utilize 7.4% of the cPAD for the U.S. population, 24% of the cPAD for all infants (< 1 year old) and 22% of the cPAD for children 1-6 years old. There are no residential uses for cyprodinil that result in chronic residential exposure to cyprodinil. Based the use pattern, chronic residential exposure to residues of cyprodinil is not expected. In addition, there is potential for chronic dietary exposure to cyprodinil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure take into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Cyprodinil is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

5. Aggregate cancer risk for U.S. population. Cyprodinil has been classified as ``not likely to be carcinogenic in humans'' based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, cyprodinil is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to cyprodinil residues.

The results of Multiresidue Method testing of cyprodinil and its metabolite CGA-232449 have been forwarded to the Food and Drug Administration (FDA). Cyprodinil was tested according to the FDA Multiresidue protocols (Protocols C, D, and E), and acceptable recoveries were obtained for cyprodinil fortified in apples at 0.50 ppm using Protocol D. The petitioner is proposing the Method AG-631A as a tolerance enforcement method for residues of cyprodinil in/on the subject crops. This method, entitled “Analytical Method for the Determination of Residues of CGA-219417 in Crops by High Performance Liquid Chromatography With Column Switching,” is a reissue of Methods AG-631 and REM 141.01. The method includes confirmatory procedures using gas chromatography/nitrogen/phosphorus detector (GC/NPD). The method has successfully undergone radiovalidation using 14C-labeled tomato samples and independent laboratory validation. In addition, the method has been the subject of acceptable Agency petition method validations on stone fruits and almond nutmeat and hulls.

There are no Mexican, Canadian or Codex maximum residue limits established for cyprodinil in/on caneberries, bushberries, pistachios and watercress, and thus no compatibility issues to be reconciled.

The Agency is requiring as conditions for registration the following:An acceptable 21/28-day dermal-toxicity study in rats (GLN 870.3200). A 28-day inhalation-toxicity study in rats (GLN 870.3465)

Therefore, the tolerance is established for residues of cyprodinil on the caneberry subgroup at 10.0 ppm, watercress at 20 ppm, pistachio at 0.10 ppm and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number -OPP-2002-0344 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 7, 2003.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2002-0344, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a tolerance under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop producers (NAICS 111)

• Animal producers (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

1. Docket. EPA has established an official public docket for this action under docket identification (ID) number OPP-2002-0355. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the “Federal Register” listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I.B.1. Once in the system, select “search,” then key in the appropriate docket ID number.

EPA, on its own initiative, in accordance with sections 408(e) and 408 (l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing a tolerance for residues of the fungicide thiophanate methyl and its metabolite (methyl 2-benzimidazoyl carbamate (MBC)), in or on mushroom at 0.01 parts per million (ppm). This tolerance will expire and is revoked on December 31, 2004. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations.

Section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18-related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408(e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Benomyl has historically been used in mushroom production to control fungal pathogens, including one of the most serious, green mold (Trichoderma aggresivum). The registrant's recent cancellation of benomyl has left mushroom growers in Delaware, Maryland, and Pennsylvania without sufficient means to control this disease, as there are no available alternatives. Significant economic losses are expected without the requested use of thiophanate methyl. EPA has authorized under FIFRA section 18 the use of thiophanate methyl on mushroom spawn for control of green mold in Delaware, Maryland, and Pennsylvania. After having reviewed their submissions, EPA concurs that emergency conditions exist for these States.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of thiophanate methyl in or on mushroom. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although this tolerance will expire and is revoked on December 31, 2004, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on mushroom after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this tolerance at the time of that application. EPA will take action to revoke this tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this tolerance is being approved under emergency conditions, EPA has not made any decisions about whether thiophanate methyl meets EPA's registration requirements for use on mushroom or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this tolerance serves as a basis for registration of thiophanate methyl by a State for special local needs under FIFRA section 24(c). Nor does this tolerance serve as the basis for any State other than Delaware, Maryland, and Pennsylvania to use this pesticide on this crop under section 18 of FIFRA without following all provisions of EPA's regulations implementing FIFRA section 18 as identified in 40 CFR part 166. For additional information regarding the emergency exemptions for thiophanate methyl, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT.

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of thiophanate methyl and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for residues of thiophanate methyl in or on mushroom at 0.01 ppm.

The most recent estimated aggregate risks resulting from the use of thiophanate methyl, are discussed in the Federal Register for August 28, 2002 (67 FR 55137) (FRL-7192-1), final rule establishing tolerances for residues of thiophanate methyl in/on grapes, pears, potatoes, canola, and pistachios. Available residue data did not indicate that this use pattern will result in residues of thiophanate methyl in mushrooms over the limit of quantitation (LOQ), 0.01 ppm. Therefore, a tolerance is being established for mushroom at this level. Incremental addition of mushrooms at this level to dietary exposure, from existing food/feed uses, is negligible. Additionally, the results for this section 18 use do not alter the current aggregate exposure assessments with respect to drinking water or residential exposure. Refer to the August 28, 2002 Federal Register document for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon that risk assessment and the findings made in the Federal Register document in support of this action. Below is a brief summary of the aggregate risk assessment.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. A summary of the toxicological dose and endpoints for thiophanate methyl for use in human risk assessment is discussed in the final rule mentioned above, published in the Federal Register of August 28, 2002 (67 FR 55137).

For thiophanate methyl, the Agency recently modified the tolerance expression, so that the residues to be regulated in plant and animal commodities for purposes of tolerance enforcement will consist of the residues of thiophanate methyl and its metabolite (methyl 2-benzimidazolyl carbamate (MBC)), expressed as thiophanate methyl.

Exposure from the use of benomyl, another pesticide which degrades under environmental conditions to MBC was not included in this assessment because the only basic registrant of benomyl requested voluntary cancellation of all benomyl-containing products in April 2001. Product cancellations were effective in early 2001 with sales and distribution of benomyl-containing products ending by December 31, 2001. However, the Agency conducted a dietary assessment using USDA Pesticide Data Program (PDP) monitoring data for benomyl, measured as MBC to estimate residues of thiophanate methyl because MBC is a common metabolite of both benomyl and thiophanate methyl. PDP data were available for apples, bananas, beans, cucurbits, peaches, and strawberries. The PDP analytical method employs a hydrolysis step that converts any benomyl present to MBC. MBC is then quantitated and corrected for molecular weight, and results are measured as the sum of benomyl and MBC. Therefore, using MBC data to estimate thiophanate methyl residues may be a conservative approach in that it may over estimate thiophanate methyl residues.

EPA assessed risk scenarios for thiophanate methyl under acute, chronic, and short- and intermediate-term exposures.

The Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity.

For the acute exposure assessments, maximum percent crop treated estimates and anticipated residue estimates were used.

Using these exposure assumptions, EPA concluded that acute dietary exposure to thiophanate methyl uses 10% of the acute Population Adjusted Dose (aPAD) for the general U.S. population and 25% of the aPAD for the most highly exposed population subgroup of concern, infants (< 1 year). For MBC, the acute dietary risk estimate uses 4% of the aPAD for the general U.S. population and 89% of the aPAD for the population subgroup of concern, infants (< 1 year). The total thiophanate methyl plus MBC acute dietary risk estimate for the population subgroup of concern, females (13-50 years) uses 51% of the aPAD. The drinking water assessment, based on simultaneous dietary exposure to both MBC and thiophanate methyl (which was converted to MBC equivalents) resulted in the following Drinking Water Levels of Concern (DWLOCs): Infants (< 1 year) 18 ppb; children (1-6 years) 57 ppb; females (13-50 years) 150 - 170 ppb; and general U.S. population 5,700 ppb. The lowest DWLOC for the population subgroup, infants (< 1 year) does not exceed the Estimated Environmental Concentration (EEC) for ground water (0.033 ppb); however, the DWLOC does exceed the EEC for surface water (25 ppb). Although the EEC is exceeded, the DWLOC is greatly inflated because 50% of the aPAD percentage is consumed by citrus which is a 1-year emergency use only. When citrus is removed from the DWLOC estimation, the DWLOC becomes 94 ppb which is well above the EEC of 25 ppb. The DWLOC is significantly lowered by the addition of citrus because field trial data was used which results in an overly conservative estimation.

Another indication that the addition of citrus based on field trial data results in an over estimation is the fact that benomyl PDP data available for citrus indicated that there were zero hits out of 689 Florida samples of orange juice. These data were not used to refine the DWLOC estimation because the benomyl application rate is somewhat lower than the rate approved for thiophanate methyl in this year's emergency exemption. However, the Agency believes that most growers used the benomyl rate, because the emergency exemption was approved later in the use season and thus fewer applications than were authorized were actually used. Furthermore, if the higher rate were used, the impact would be lessened by the fact that juice is a blended commodity. Therefore, although the DWLOC is exceeded, the acute dietary risk from food and water does not exceed the Agency's level of concern.

For the chronic exposure assessments, average residues from field trial data and average percent crop treated estimates were used.

Using these exposure assumptions, EPA has concluded that exposure to thiophanate methyl and MBC will utilize the following percentages of the chronic Population Adjusted Dose (cPAD) for the U.S. population: Thiophanate methyl - 0.7%; MBC - 1.0% and total thiophanate methyl plus MBC - 1.7%. The major identifiable subgroup with the highest aggregate exposure is children (1-6 years) and EPA has concluded that aggregate dietary exposure to thiophanate methyl and MBC will utilize the following percentages of the cPAD: Thiophanate methyl - 2.3%; MBC - 26% and total thiophanate methyl plus MBC -28%. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. The aggregate chronic DWLOC's are as follows: 858 ppb for the general U.S. population; 69 ppb for females (13-50 years); 22 ppb for infants (< 1 year); and 18 ppb for children (1-6 years). The aggregate surface water EECs for thiophanate methyl is 0.7 ppb; 14 ppb for MBC and 14.7 ppb for thiophanate methyl plus MBC. Therefore, the chronic aggregate risks do not exceed the Agency's level of concern.

Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Thiophanate methyl and MBC are currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for thiophanate methyl and MBC.

All residential exposures are considered to be short-term. The Margins of Exposure (MOEs) (converted to MBC equivalents) for aggregate short-term exposure to thiophanate methyl are as follows: Oral exposure of children (1-6 years) is 670; dermal exposure of children (1-6 years) is 1,000; and dermal exposure of females (13-50 years) is 1,315. The MOEs for aggregate exposure to MBC from the use of MBC as an in-can preservative are 670 for dermal exposure and 770 for exposure via inhalation. The MOEs (converted to MBC equivalents) for the total thiophanate methyl and MBC aggregate exposure are as follows: 630 for oral and dermal exposure of children (1-6 years); 770 for exposure via inhalation for females (13-50 years); and 620 for oral and dermal exposure for females (13-50 years). Although the MOEs below 1,000 exceed the Agency's level of concern, when considering the conservative method of exposure estimation previously discussed, and the negotiated risk mitigation whereby the registrant has agreed to conduct hand-press studies to help refine this assessment, the risks do not exceed the Agency's level of concern.

Aggregate cancer risk for U.S. population. The total thiophanate methyl and MBC dietary cancer risk is 8.5 x 10-7 for existing and new uses. The cancer risk from non-occupational residential exposure is 3.7 x 10-7. The aggregate cancer risk is 1.2 x 10-6. This risk estimate includes cancer risk from both thiophanate methyl and MBC on food including all pending uses and section 18 uses, thiophanate methyl exposure from treating ornamentals, thiophanate methyl exposure from performing post-application lawn activities, and exposure from applying paint containing MBC. This is considered to be a high-end risk scenario since it is not expected that someone would treat ornamentals, perform high exposure post-application activities, and apply paint containing MBC every year for 70 years. Therefore, this estimate is considered to be a conservative estimate. Additionally, the cancer risk estimate based on the highest EEC (thiophanate methyl plus MBC EEC) is 9.6 x 10-7. This is also a very high-end risk estimate since it is based on the maximum rate being applied every season for 70 years. Thus, food plus water (assuming that the modeled surface water EEC is equivalent to concentrations in finished drinking water) plus non-occupational residential cancer risk is 2.2 x 10-6 which is still within the range considered as negligible. In addition, the cancer risk estimates using benomyl/MBC PDP monitoring data to estimate thiophanate methyl residues are below 1 x 10-6 for thiophanate methyl existing uses, new uses, and the amortized section 18 use on citrus and blueberry. Therefore, the risks do not exceed the Agency's level of concern.

Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to thiophanate methyl and MBC residues.

Adequate enforcement methodology is available to enforce the tolerance expression. The method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

The Codex Alimentarius Commission has established maximum residue limits (MRLs) for thiophanate methyl residues in/on various plant and animal commodities. Codex MRLs for thiophanate methyl are currently expressed as MBC. The Codex MRL residue definition and the U.S. tolerance definition, previously expressed as only thiophanate methyl, have been incompatible and will remain incompatible even with the recent revision of the U.S. tolerance definition, since the revised tolerance definition includes both thiophanate methyl and MBC. Additionally, there is a 1.0 ppm Codex MRL for thiophanate methyl on mushroom. The 0.01 ppm tolerance being established by this document will not harmonize with Codex.

The pesticide, thiophanate methyl, is to be mixed at 1.4 lbs. active ingredient (a.i.) (2 lbs. product) with 80 to 100 lbs. of gypsum, limestone, or chalk. This mixture will then be used to coat spawn grains (approximately 1,600 units) before mixing the spawn into the mushroom growing substrate. The substrate will then be applied to bed surface before spawning.

Therefore, the tolerance is established for residues of thiophanate methyl and its metabolite, (methyl 2-benzimidazoyl carbamate (MBC), expressed as thiophanate methyl, in or on mushroom at 0.01 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) of the FFDCA provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d) of the FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2002-0355 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 7, 2003.

1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections (40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues(s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector (40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice.

Mail your written request to: Office of the Hearing Clerk (1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. You may also deliver your request to the Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (703) 603-0061.

2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it “Tolerance Petition Fees.”

EPA is authorized to waive any fee requirement “when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.” For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov, or by mailing a request for information to Mr. Tompkins at Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

3.Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by the docket ID number OPP-2002-0355, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues(s) in the manner sought by the requestor would be adequate to justify the action requested (40 CFR 178.32).

This final rule establishes a time-limited tolerance under section 408 of the FFDCA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under section 408 of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the National Flood Insurance Program, 42 U.S.C. 4001 et seq.; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59 et seq. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register.

In addition, the Federal Emergency Management Agency has identified the special flood hazard areas in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in the identified special flood hazard area of communities not participating in the NFIP and identified for more than a year, on the Federal Emergency Management Agency's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives a 6-month, 90-day, and 30-day notification addressed to the Chief Executive Officer that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications have been made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR Part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless they take remedial action.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Executive Order 12612, Federalism. This rule involves no policies that have federalism implications under Executive Order 12612, Federalism, October 26, 1987, 3 CFR, 1987 Comp.; p. 252.

Executive Order 12778, Civil Justice Reform. This rule meets the applicable standards of section 2(b)(2) of Executive Order 12778, October 25, 1991, 56 FR 55195, 3 CFR, 1991 Comp.; p. 309.

The FCC published a document in the Federal Register of October 31, 2002 (67 FR 66340), dismissing an Application for Review filed by Big Broadcast of Arizona, LLC directed to the Report and Order in this proceeding. See 65 FR 11540, March 3, 2000. In FR Doc. 02-27693, the amendatory language was omitted. This correction adds the amendatory language to the document.

In rule FR Doc. 02-27693 published on October 31, 2002 (67 FR 66340), make the following correction. On page 66341, in the first column, after line 15, add the following amendatory language:

This is a synopsis of the Commission's Memorandum Opinion and Order in MM Docket No. 01-131, and MM Docket No. 01-133 adopted January 2, 2003, and released January 3, 2003. The full text of this decision is available for inspection and copying during normal business hours in the FCC Reference Information Center at Portals ll, CY-A257, 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, Qualex International, Portals II, 445 12th Street, SW, Room CY-B402, Washington, DC 20554, telephone (202) 863-2893, facsimile (202) 863-2898, or via e-mail qualixint@aol.com.

This is a synopsis of the Commission's Report and Order, MB Docket No. 02-351, adopted January 15, 2003, and released January 17, 2003. The full text of this Commission decision is available for inspection and copying during normal business hours in the Commission's Reference Center, 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, Qualex International, Portals II, 445 12th Street, SW, Room CY-B402, Washington, DC 20554, telephone 202-863-2893, facsimile 202-863-2898, or via e-mail qualexint@aol.com.