Citrus canker is a disease that affects citrus and is caused by the infectious bacteriumXanthomonas campestrispv.citri(Hasse) Dye. The strain of citrus canker that occurs in Japan infects twigs, leaves, and fruit in a wide spectrum of citrus species.

Currently, the regulations in 7 CFR 319.28 (referred to below as the regulations) prohibit the importation of citrus from Eastern and Southeastern Asia, Japan, Brazil, Paraguay, and other designated areas, with certain exceptions. One exception is for Unshu oranges (Citrus reticulataBlanco var.unshu,also known as Satsuma) grown in citrus-canker-free areas of Japan or on Cheju Island, Republic of Korea. After meeting certain growing, packing, and inspection requirements, Unshu oranges may be imported from these areas of Japan and Korea into any area of the United States except American Samoa, Arizona, California, Florida, Louisiana, the Northern Mariana Islands, Puerto Rico, Texas, and the U.S. Virgin Islands. Also, under the regulations in 7 CFR 301.11, the interstate movement of Unshu oranges is prohibited from any State or area into which they may be imported into or through any State or area where importation is prohibited under § 319.28.

Unshu oranges eligible for importation into the United States are grown under a system of safeguards in citrus-canker-free areas in Japan and Korea. Unshu oranges are known to be resistant to citrus canker, and the system of safeguards established in the regulations for Unshu oranges approximately 30 years ago has proven effective, as evidenced by the record of citrus-canker-free imports.

On April 18, 2001, we published in theFederal Register(66 FR 19892-19898, Docket No. 99-099-1) a proposed rule to amend regulations governing the importation of citrus fruit to allow, under certain conditions, Unshu oranges grown on Kyushu Island, Japan, to be imported into non-citrus-producing areas of the United States. We also proposed to amend the regulations for importing Unshu oranges from Honshu Island, Japan, by requiring fumigation using methyl bromide prior to exportation and by allowing the fruit to be distributed to additional areas in the United States, including citrus-producing areas. Finally, we proposed to remove the requirement for individually wrapping Unshu oranges imported from Japan or the Republic of Korea.

We solicited comments concerning our proposal for 60 days ending June 18, 2001. We received five comments by that date. These comments were from State agricultural agencies, a citrus growers cooperative, and a university. All of the commenters raised specific concerns regarding the proposed rule. Those concerns are discussed below by topic.

Two commenters opposed allowing Unshu oranges from Japan to enter citrus-producing areas of the United States under any conditions due to the risk of citrus canker. One of the commenters argued that fruit treatments and growing area inspections have not been conclusively proven to eliminate that risk. We believe that the risk of citrus canker being introduced into citrus-producing areas via imported Unshu oranges is almost nonexistent. The pest risk assessment estimated that the probability of the citrus canker bacterium (Xanthomonas campestrispv.citri) from imported Unshu orange fruits coming in contact with and infecting a suitable host material and establishing was nearly zero. The published literature indicates that no authenticated outbreak of citrus canker has ever been traced back to the importation of infected fruit. In addition, the Unshu oranges are known for their resistance to the disease.

Three commenters opposed removing the requirement to wrap individual oranges, especially given some Unshu oranges from Japan would be allowed into citrus-producing areas and others would not. These commenters argued that once cartons are opened and fruit distributed, it would be difficult to identify the origin of individual oranges. As we noted in the proposed rule, we will continue to require that each box containing fruit will have to be clearly marked with the States into which the fruit may be imported, and from which they are prohibited removal under a Federal plant quarantine. Our experience has shown that Unshu oranges are marketed and retailed by the box. We do not think that wrapping of individual fruits with tissue paper provides additional phytosanitary security; any importers engaged in swapping boxes to misrepresent theorigin (i.e., Kyushu-grown oranges in Honshu boxes) could also engage in swapping or fabricating wrapping papers.

Three commenters suggested that methyl bromide fumigation should be required for all Unshu oranges entering the United States from Japan, not just for Unshu oranges grown on Honshu. One of these commenters argued that three mealybugs identified in the pest risk assessment (Planococcus kraunhiae, P. lilacinus,andPseudococcus cryptus) have a relatively wide host range and could move from imported Unshu oranges to other host material and become established in the United States. APHIS' fumigation requirement for the oranges grown on Honshu is an additional protective measure imposed because the Honshu-grown fruit can be distributed in U.S. citrus-producing areas. Because the distribution of Kyushu-grown fruit will be limited to non-citrus-producing areas, we believe that the existing safeguards will be sufficient. During the required inspections by APHIS personnel in Japan and at the U.S. port of entry, APHIS inspectors specifically target mealybugs; any shipments of Unshu oranges from Kyushu or Honshu found to be infested with mealybugs (or any other quarantine significant pest) will be prohibited entry into the United States.

Two commenters suggested that APHIS should update the 1995 pest risk assessment “Importation of Japanese Unshu Orange Fruit into Citrus Producing States,” given the age of the document and the fact that Japan's work plan for the Unshu orange program does not refer to some of the pests identified as quarantine significant (e.g., the citrus fruit fly) in the pest risk assessment. We believe that the 1995 risk assessment is still applicable, given that no incidence of citrus canker or finding of a new pest of concern in the Japanese production areas has been reported or recorded since the assessment was prepared. With regard to Japan's work plan, it has not been necessary for that document to address the citrus fruit fly because that pest is not known to occur on Honshu, which has been the only area from which Unshu oranges could be imported into the United States. We will work with Japanese officials to ensure that the programmatic changes resulting from this rule are reflected in an updated work plan.

Two commenters suggested that the risks presented by citrus canker and citrus greening would require that minimal acceptable growing and domestic movement standards within Japan be the same as those imposed on Florida for movement of commercial citrus. Citrus greening disease and its vector,Diaphorina citri,are reported as occurring only in the Ryuku Archipelago in Japan and have not been reported on Honshu or Kyushu. WhileD. citriwas detected in southeastern Florida in June 1998—the only reported detection of the pest in the United States—populations of the pest are being controlled through a classical biological control program, according to a pest alert prepared by the University of Florida and the Florida Department of Agriculture and Consumer Services, Division of Plant Industry. Further,D. citribreeds exclusively on young flush and feeds on leaves and shoots of citrus, and the citrus greening bacterium is phloem restricted, making the fruit an unlikely pathway for the vector or the disease. With regard to citrus canker, we have noted in this document and elsewhere that Unshu oranges themselves are highly resistant to citrus canker and the required growing conditions in Japan all but eliminate the risk of citrus canker being introduced via Unshu oranges from Japan.

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

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 theFederal Register.

Immediate implementation of this rule is necessary to provide relief to those persons who are adversely affected by restrictions we no longer find warranted. The shipping season for Unshu oranges from Japan is in progress. Making this rule effective immediately will allow interested producers and others in the marketing chain to benefit during this year's shipping season. Therefore, the Administrator of the Animal and Plant Health Inspection Service has determined that this rule should be effective upon signature.

This final 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.

The economic analysis for the changes in this document is set forth below. It provides a cost-benefit analysis as required by Executive Order 12866 and an analysis of the potential economic effects on small entities as required by the Regulatory Flexibility Act.

In the data used to prepare this analysis, the terms “tangerine” and “mandarin” are generally interchangeable. Both refer to varieties ofCitrus reticulata. For example, National Agricultural Statistics Service (NASS) production data are aggregated under “tangerine,” while Census Bureau trade data use the term “mandarin.” Because of its familiarity, we use only the term “tangerine” in this analysis.

Unshu oranges (Citrus reticulatavar.unshu) are a variety of tangerine currently allowed to be imported into the United States from citrus canker-free production areas of Japan and Korea. They may be imported into any part of the United States except for commercial citrus-producing areas. This rule amends the provisions regarding the importation of Unshu oranges from Honshu Island, where all such shipments from Japan originated prior to this rule, and allow importations from four prefectures on Kyushu Island. Unshu oranges imported from Honshu Island will no longer be prohibited from being distributed in five citrus-producing States (Arizona, California, Florida, Louisiana, and Texas), and postharvest treatment with methyl bromide will be mandatory. Unshu oranges from Kyushu Island will be prohibited from being distributed in those five citrus-producing States, American Samoa, the Northern Mariana Islands, Puerto Rico, and the U.S. Virgin Islands, and methyl bromide treatment will not be mandatory. This rule also removes the requirement that imported Unshu oranges be individually wrapped, regardless of whether they come from Japan or Korea.

Because Unshu oranges are not grown in the United States, entities that might be affected by this rule will be producers of other tangerine varieties, assuming Unshu oranges can be considered a substitute fruit. Annual receipts of $750,000 or less is the small-entity criterion set by the Small Business Administration for establishments primarily engaged in the production of citrus fruits. Most tangerine producers in the United States are small entities. Although the1997 Census of Agricultureexcluded information on California's “honey tangerine” growers to avoid disclosing data for individual farms, the information that is available for “other tangerine” growers in California and other States indicates that most operations are small.

Quantities of Unshu oranges imported from Japan and Korea between 1994 and 1999 are shown in Table 1. Unshu orange imports from Japan between 1994 and 1999 averaged 240 metric tons per year.

Japan's Ministry of Agriculture, Forestry and Fisheries is unable to project future Unshu orange exports to the United States that may result from this final rule. For the purposes of this analysis, therefore, we estimated that the level of imports would be double the 1994-1999 average, i.e., 480 metric tons per year. Adding to this amount the average of yearly imports from Korea shown in Table 1, namely, 310 metric tons, would mean 790 metric tons of Unshu oranges imported annually. The estimated increase in imports from Japan may be too high, but we do not have information that would allow a more factually based projection. A high estimate of the potential increase in Japan's Unshu orange exports to the United States lends confidence to our conclusion regarding the potential economic effect on U.S. tangerine producers.

U.S. tangerine production, imports, and domestic supplies are shown in Table 2. U.S. net imports were less than 4 percent of the domestic supply in 1997-98. In addition, as Table 2 shows, the United States shifted from being a net exporter from 1994 through 1996 to being a net importer of tangerines beginning in 1996, reflecting increased demand for imported varieties. Annual exports from 1994 through 1998 were fairly constant at about 33,400 metric tons. Imports, however, increased sharply, from about 20,000 metric tons in 1994-95, to about 42,800 metric tons in 1997-98.

Comparing Unshu orange imports shown in Table 1 with U.S. tangerine supplies shown in Table 2, it is apparent that Unshu orange imports comprise a small portion of total supply. From 1994-95 to 1997-98, they averaged only 0.23 percent of U.S. tangerine supply, and when only the fruit imported from Japan is considered, 0.11 percent. The hypothesized import level, 790 metric tons a year, represents only 0.36 percent of the average annual tangerine domestic supply over this 4-year period. This very small percentage suggests that any effect of Unshu orange imports, as a substitute fruit, on the sales and prices of other tangerine varieties as a whole would not be significant.

One seedless variety that is similar to the Unshu orange is the Satsuma. In the United States, it is commercially grown only in California, where there were 1,368 acres of bearing and 753 acres of nonbearing (young) trees as of May 1999, according to the California Department of Food and Agriculture. Satsuma production statistics are not recorded at the national or State level. Nearly all commercial production takes place in Fresno, Kern, and Tulare Counties, CA. Of these, only Fresno County maintains information specific to Satsumas. In 1997-98, there were 2,332 metric tons of Satsuma produced on 470 acres in Fresno County. Based on those production levels, we estimate that the entire area of California planted with Satsuma annually produces 6,785 metric tons of fruit and could potentially produce 10,520 metric tons of fruit. The hypothesized quantity of Unshu orange imports, 790 metric tons, represents 11.6 and 7.5 percent, respectively, of the estimated California Satsuma production levels (i.e., the estimated annual production and estimated potential production levels).

Direct access to California markets will allow Unshu orange imports from Honshu Island to compete more directly for California's Satsuma consumers. However, prices of the two varieties are not competitive. Wholesale prices for Satsuma in 1997-98 were about 40 to 50 cents per pound. Wholesale prices for Unshu oranges for the past 6 to 7 years have been around $1.40 to $1.50 per pound ($45 to $48 per 32-pound container). One company has been the sole importer of Unshu oranges from Japan for more than 10 years. Information from the U.S. Department of Commerce, Bureau of the Census, shows that the average price of all tangerines imported by the United States from 1994 to 1998 was more in line with Satsuma prices, at about 47 cents per pound. A price difference of this magnitude implies distinct markets; it is highly unlikely that Satsuma customers will be willing to pay a threefold premium for a substitute variety. There may be latent demand for Unshu oranges in the United States, but the extent to which this demand draws away consumers of Satsuma and other domestic tangerine varieties is expected to be marginal. More likely, Unshu orange sales in citrus-producing States and elsewhere will be to an expanding base of niche customers willing to pay the premium price for Unshu oranges.

The effect on the demand for otherCitrus reticulatavarieties from increased levels of Unshu orange imports is expected to be negligible. Even when the analysis focuses more narrowly on a similar tangerine variety, the Satsuma, the higher prices paid for Unshu oranges strongly indicate a distinct market, with any effect on Satsuma sales likely to be insignificant.

An increase in the importation of Unshu oranges is expected, given the addition of Unshu oranges grown on Kyushu Island and the opportunity for Unshu oranges from Honshu Island to be marketed in U.S. citrus-producing States. The requirement that shipments from Honshu Island be fumigated using methyl bromide will not affect the volume of Unshu oranges exported, since all shipments from that island are already fumigated voluntarily. Whether the fruit continues to be wrapped after individual fruit wrappers are no longer required will probably be determined largely by customer preference.

As explained, increases in the quantity of Unshu oranges imported from Japan are not expected to have a significant economic effect on U.S. tangerine producers, whether the producer is a small or large entity.

Economic effects on U.S. producers and consumers resulting from this rule are expected to be insignificant. As described, projected Unshu orange imports represent about one-third of 1 percent of domestic tangerine supply. This small amount is unlikely to affect the demand for other tangerines, especially given that Unshu orange prices are triple those of other tangerines. U.S. retailers and consumers of Unshu oranges will benefit, particularly those in citrus-producing States that currently do not have direct access to them.

Alternatives to this rule would be to either maintain existing import regulations or propose restrictions different from those set forth here. The risk assessment supports neither alternative. Japanese sources and U.S. destinations can be expanded without jeopardizing the U.S. citrus industry. The economic effect will be positive, but very minor.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

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

An environmental assessment and finding of no significant impact have been prepared for this final rule. The assessment provides a basis for the conclusion that the importation of Unshu oranges grown at approved locations in Japan and imported into certain areas of the United States under the conditions specified in this final rule will not present a risk of introducing or disseminating citrus canker, citrus fruit fly, and mealybugs and will not have a significant impact on the quality of the human environment. Based on the finding of no significant impact, the Administrator of the Animal and Plant Health Inspection Service has determined that an environmental impact statement need not be prepared.

The environmental assessment and finding of no significant impact were prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321et seq.), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

Copies of the environmental assessment and finding of no significant impact are available for public inspection at USDA, room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m., Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead on (202) 690-2817 to facilitate entry into the reading room. In addition, copies may be obtained by writing to the individual listed underFOR FURTHER INFORMATION CONTACT.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501et 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 0579-0173.

The regulations in 9 CFR parts 93, 94, 95, and 96 (referred to below as the regulations) govern the importation of certain animals, birds, poultry, meat, other animal products and byproducts, hay, and straw into the United States in order to prevent the introduction of various animal diseases, including bovine spongiform encephalopathy (BSE).

BSE is a neurological disease of cattle and is not known to exist in the United States. It appears that BSE is primarily spread through the use of ruminant feed containing protein and other products from ruminants infected with BSE. Therefore, BSE could become established in the United States if materials carrying the BSE agent, such as certain meat, animal products, and animal byproducts from ruminants, are imported into the United States and are fed to ruminants in the United States. BSE could also become established in the United States if ruminants withBSE are imported into the United States.

Sections 94.18, 95.4, and 96.2 of the regulations prohibit or restrict the importation of certain meat and other animal products and byproducts from ruminants that have been in regions in which BSE exists or in which there is an undue risk of introducing BSE into the United States.

Paragraph (a)(1) of § 94.18 lists the regions in which BSE exists. Paragraph (a)(2) lists the regions that present an undue risk of introducing BSE into the United States because their import requirements are less restrictive than those that would be acceptable for import into the UnitedStates and/or because the regions have inadequate surveillance. Paragraph (b) of § 94.18 prohibits the importation of fresh, frozen, and chilled meat, meat products, and most other edible products of ruminants that have been in any region listed in paragraphs (a)(1) or (a)(2). Paragraph (c) of § 94.18 restricts the importation of gelatin derived from ruminants that have been in any of these regions. Section 95.4 prohibits or restricts the importation of certain byproducts from ruminants that have been in any of those regions, and § 96.2 prohibits the importation of casings, except stomach casings, from ruminants that have been in any of these regions. Additionally, the regulations in 9 CFR part 93 pertaining to the importation of live animals provide that the Animal and Plant Health Inspection Service may deny the importation of ruminants from regions where a communicable disease such as BSE exists and from regions that present risks of introducing communicable diseases into the United States (see § 93.404(a)(3)).

Currently, Slovakia and Slovenia are among the regions listed in § 94.18(a)(2), which are regions that present an undue risk of introducing BSE into the United States. (Slovakia is currently listed in § 94.18(a)(2) as “the Slovak Republic.”) However, on October 5, 2001, a case of BSE was confirmed in a native-born animal in Slovakia. A case of BSE was confirmed in a native-born animal in Slovenia on November 21, 2001. Therefore, in order to update the disease status of these regions regarding BSE, we are amending the regulations by removing Slovakia and Slovenia from the list in § 94.18(a)(2) of regions that present an undue risk of introducing BSE into the United States and adding Slovakia and Slovenia to the list in § 94.18(a)(1) of regions where BSE is known to exist. The effect of this action is a continued restriction on the importation of ruminants that have been in Slovakia or Slovenia and on the importation of meat, meat products, and certain other products and byproducts of ruminants that have been in either of those countries.

As noted above, the regulations in § 94.18(a)(2) have referred to Slovakiaby its conventional long form name, the Slovak Republic. For consistency with the manner in which we refer to other countries in the regulations, we use the conventional short form designation of “Slovakia” in this interim rule.

This rulemaking is necessary on an emergency basis to update the disease status of Slovakia and Slovenia regarding BSE. 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 theFederal Register.

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

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

We are amending the regulations by adding Slovakia and Slovenia to the list of regions where BSE exists because the disease has been detected in native-born animals in those regions. Slovakia and Slovenia are currently listed among the regions that present an undue risk of introducing BSE into the United States. Regardless of which of the two lists a region is on, the same restrictions apply to the importation of ruminants and meat, meat products, and most other products and byproducts of ruminants that have been in the region. Therefore, this action, which is necessary in order to update the disease status of Slovakia and Slovenia regarding BSE, will not result in any change in the restrictions that apply to the importation of ruminants and meat, meat products, and certain other products and byproducts of ruminants that have been in Slovakia and Slovenia.

Under these circumstances, the Administrator of the Animal and Plant Health InspectionService has determined that this action will not have a significant economic impact on a substantial number of small entities.

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. 3501et seq.).

Accordingly, we are amending 9 CFR part 94 as follows:

A proposal to amend 14 CFR part 39 by superseding AD 2000-22-51, Amendment 39-12034 (65 FR 77263, December 11, 2000), which applies to Model HH-1K, TH-1F, TH-1L, UH-1A, UH-1B, UH-1E, UH-1F, UH-1H, UH-1L, UH-1P, and Southwest Florida Aviation Model SW204, SW204HP, SW205, and SW205A-1 helicopters, manufactured by BHTI for the Armed Forces of the United States, was published in theFederal Registeron September 21, 2001 (66 FR 48631). In addition to retaining several of the requirements of AD 2000-22-51, that action proposed establishing a retirement life for the trunnions based on monitoring the number of torque events and flight hours. Also proposed was adding a note clarifying that the mast S/N is defined by 5 or fewer digits plus various prefixes.

Interested persons have been afforded an opportunity to participate in the making of this amendment. Due consideration has been given to the comment received.

The one commenter states that when the details in paragraphs (a)(2)(i) and (b)(2)(i) of the AD are unavailable for a particular component but the total time-in-service (TIS) is known, he suggests that the worst possible combination for RIN and TIS count should be applied and recorded and the FAA should not require that the component be removed from service. The FAA does not concur. Even assuming the worst case scenario proposed by the commenter would not necessarily provide an appropriate safety margin. The helicopter model installation history and the hours TIS are required to ensure that the mast or trunnion has not been installed on any ineligible helicopter. Masts purchased from the U.S. military should have the part records with the helicopter model installation history and hours TIS.

The FAA has determined that air safety and the public interest require the adoption of the rule as proposed except that an editorial change has been made to the reporting requirements information, paragraph (9) of the AD. The FAA has determined that this change neither increases the economic burden on any operator nor increases the scope of the AD.

The FAA estimates that this AD will affect 75 helicopters of U.S. registry. The FAA also estimates that it will take 10 work hours to replace the trunnion, 2 work hours per helicopter to create a new component history card or equivalent record for the trunnions and that the average labor rate is $60 per work hour. Required trunnions will cost approximately $5,300 per helicopter. Based on these figures, the total cost impact of this AD on U.S. operators is estimated to be $451,500.

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 FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas.

The Direction Generale De L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on ECF Model SE 3130, SE 313B, SA 315B, SE 3160, SA 316B, SA 316C, SA 3180, SA 318B, SA 318C, and SA 319B helicopters with certain MGBs installed. The DGAC advises of the discovery of a crack on the bevel gear installed on an Alouette helicopter, which may cause failure of the MGB, subsequent loss of the main rotor drive, and an auto-rotation landing.

ECF has issued Alert Telex 01.67 and 01.32, dated April 20, 2001, and Alert Service Bulletins 01.32 and 01.67, both dated July 18, 2001, specifying a dye-penetrant inspection of both bevel gear faces in the coupling areas of the bevel gear and the bevel gear housing assembly of the MGB. The DGAC classified these service bulletins as mandatory and issued ADs 2001-149-044(A) R1, 2001-178-058(A) R1, and 2001-179-061(A) R1, all dated August 8, 2001, to ensure the continued airworthiness of these helicopters in France.

These helicopter models are manufactured in France and are type certificated for operation in the United States under the provisions of 14 CFR 21.29 and the applicable bilateral agreement. Pursuant to the applicable bilateral 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 may operate in the United States.

This unsafe condition may exist or develop on other helicopters of the same type designs with these certain MGBs installed. We are issuing this AD to prevent failure of an MGB due to a cracked bevel gear, loss of the main rotor drive, and subsequent loss of control of the helicopter. This AD requires inspecting the MGB magnetic plug for metal particles at intervals not to exceed 10 hours TIS. This AD also requires, within 50 hours TIS, dye-penetrant inspecting the bevel gear for a crack and, if a crack is found, replacing the unairworthy bevel gear with an airworthy bevel gear before further flight. Replacing a cracked bevel gear is terminating action for the requirements of this AD.

None of the eight MGBs affected by this action are currently installed on helicopters on the U.S. Register. All helicopters included in the applicability of this rule that have an affected MGB installed are currently operated by non-U.S. operators under foreign registry; therefore, they are not directly affected by this AD action. However, the FAA considers that this rule is necessary to ensure that the unsafe condition is addressed in the event that any of these affected MGBs are imported and installed on helicopters on the U.S. Register in the future.

Should an affected MGB be imported and installed on a helicopter on the U.S. Register in the future, it would require approximately1/2work hour to review the records for a certain MGB. If the affected MGB is present, the FAA estimates that it would take 30 work hours per helicopter to inspect the bevel gear. The average labor rate is $60 per work hour. Required parts would cost approximately $14,500 per helicopter to replace a cracked bevel gear. Based on these figures, the total cost impact of this AD would be $16,330, assuming one helicopter requires replacement of the bevel gear.

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

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 captionADDRESSES.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 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 mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2001-SW-38-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 notice and prior public comment are unnecessary in promulgating this regulation; therefore, it can be issued immediately to correct an unsafe condition in aircraft since none of these model helicopters are registered in the United States. The FAA has also determined that this regulation 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 captionADDRESSES.

On December 21, 2001, the FAA issued Emergency AD 2001-26-54 for ECF Model EC 155B which requires, before further IFR flight, inserting a copy of the AD into the Limitations Section of the RFM and replacing each affected SMD45H as specified. Removing the AD from the RFM is required after replacing each affected SMD45H. That action was prompted by the discovery of an error in the assembly of an internal connector of the SMD45H that sometimes results in an inversion of the display information. The SMD45H provides the flightcrew with essential flight and navigation information. The emergency AD was issued to prevent erroneous flight or navigation display information, produced by a faulty SMD45H, and subsequent loss of control of the helicopter.

The FAA has reviewed Eurocopter Alert Service Bulletin No. 04A002, dated October 3, 2001 (ASB). The ASB specifies, in order to resume IFR operation, to immediately replace certain SMD45Hs. The ASB also specifies affixing placards and inserting RFM supplements informing the pilot of display anomalies, certain restrictions, and certain limitations until all SMD45Hs have been replaced.

The Direction Generale De L'Aviation Civile (DGAC), the airworthiness authority for France, notified the FAA that an unsafe condition may exist on Eurocopter France Model EC 155B helicopters. The DGAC advises that sometimes an inversion of the symbols occurs on some of the SMD45Hs. The DGAC classified the ASB as mandatory and issued AD No. 2001-439-002(A)R1, dated October 31, 2001.

This helicopter model is manufactured in France and is type certificated for operation in the United States under the provision of 14 CFR 21.29 and the applicable bilateral agreement. Pursuant to this bilateral 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 operations in the United States.

Since the unsafe condition described is likely to exist or develop on other helicopters of the same type design, the FAA issued Emergency AD 2001-26-54 to prevent erroneous flight or navigation display information, produced by a faulty SMD45H, and subsequent loss of control of the helicopter. The AD requires, before further IFR flight, the following:

• Inserting a copy of the AD into the Limitations Section of the RFM to prohibit IFR flight until the affected SMD45Hs are replaced.

• Replacing each affected SMD45H with the corresponding SMD45Hs as specified in the AD.

• After replacing the SMD45Hs in accordance with the AD, removing the AD from the RFM.

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 letters issued on December 21, 2001 to all known U.S. owners and operators of ECF Model EC 155B. These conditions still exist, and the AD is hereby published in theFederal Registeras an amendment to 14 CFR 39.13 to make it effective to all persons.

The FAA estimates that 3 helicopters of U.S. registry will be affected by this AD, that it will take approximately 6 work hours per helicopter to replace each SMD45H, and that the average labor rate is $60 per work hour. The manufacturer has stated that they will provide the SMD45Hs at no cost. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $1080 to replace a SMD45H on each affected helicopter.

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 captionADDRESSES. 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 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 mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2001-SW-71-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 tocorrect 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 FAA, Office of the Regional Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth, Texas.

On November 7, 2001, the FAA proposed to amend 14 CFR part 71 by establishing a Class E airspace area at Kayenta, AZ (66 FR 56258). Additional controlled airspace extending upward from 700 feet or more above the surface is needed to contain aircraft executing the RNAV (GPS) RWY 02 SIAP, RNAV (GPS) RWY 20 SIAP, and a NBD SIAP at Bedard Field, Kayenta, AZ. This action will provide adequate controlled airspace for aircraft executing the RNAV (GPS) RWY 02 SIAP, RNAV (GPS) RWY 20 SIAP, and a NDB SIAP to Bedard Field, Kayenta, AZ.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments to the proposal werereceived. Class E airspace designations for airspace extending from 700 feet or more above the surface of the earth are published in paragraph 6005 of FAA Order 7400.9J dated August 31, 2001, and effective September 16, 2001, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

This amendment to 14 CFR part 71 establishes a Class E airspace area at Kayenta, CA. The establishment of a Special RNAV (GPS) RWY 02, RNAV (GPS) RWY 20 SIAP has made this action necessary. The effect of this action will provide adequate airspace for aircraft executing the RNAV (GPS) RWY 02, RNAV (GPS) RWY 20, and NDB SIAP at Bedard Field, Kayenta, AZ.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation—(1) is not a “significant regulatory action” under Executive Order 128660; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

As a consequence of the terrorist attacks on the United States on September 11, 2001, the U.S. commercial aviation industry suffered severe financial losses. These losses placed the financial survival of many air carriers at risk. Acting rapidly to preserve the continued viability of the U.S. air transportation system, President Bush sought and Congress enacted the Air Transportation Safety and System Stabilization Act (“the Act”), Public Law 107-42.

Under section 101(a)(2)(A-B) of the Act, a total of $5 billion in compensation is provided for “direct losses incurred beginning on September 11, 2001, by air carriers as a result of any Federal ground stop order issued by the Secretary of Transportation or any subsequent order which continues or renews such stoppage; and the incremental losses incurred beginning September 11, 2001 and ending December 31, 2001, by air carriers as a direct result of such attacks.” The Department of Transportation previously disbursed initial estimated payments of nearly $2.5 billion of the $5 billion amount that Congress authorized, using procedures set forth in the Department's Program Guidance Letters that were widely distributed and posted on the Department's web site.

On October 29, 2001 (66 FR 54616), the Department published in theFederal Registera final rule and request for comments to establish procedures for air carriers who had received or wished to receive compensation under the Act. On January 2, 2002 (67 FR 250), the Department published amendments to the final rule responding to comments and establishing a deadline for submitting requests for compensation by indirect air carriers and wet lessors. Under the amendedfinal rule, indirect air carriers and wet lessors could submit an application for compensation within 14 days of the January 2, 2002 publication date.

On January 16, 2002, the Department received a “Request for Extension of Time to Submit Applications for Compensation Pursuant to 14 CFR Part 330” from the New York/New Jersey Foreign Freight Forwarders and Brokers Association, Inc., the J.F.K. Airport Customs Broker Association Inc., and the South Florida Non-Vessel-Operating Common Carriers and Non-Aircraft-Operating Common Carriers Association, Inc. In the request, the Associations cite the lack of notice that indirect air carriers would be considered “eligible” for compensation and that 14 days is an inadequate amount of time to “prepare, identify shipments (actual and lost), properly document all losses related to air cargo operations during the Act's stated time period (September 11 through December 31, 2001), and submit all required materials prior to the January 16, 2002 deadline.” The Associations requested an extension through January 30, 2002.

After reviewing the request for extension of time, the Department has determined that a reasonable basis exists for extending the time period. First, although the compensation provisions of the Act had been implemented soon after its enactment, the Associations are correct that the first indication that indirect air carriers and wet lessors could be eligible for compensation—albeit under narrow circumstances—did not occur until January 2. Second, the Department is sensitive to the fact that small businesses may not have had the opportunity to thoroughly review the regulations and collect the necessary information within the 14 days provided. Third, extending the time period for indirect air carriers and wet lessors to submit a compensation application is consistent with the longer time period we gave air taxis (which are also primarily small businesses) to submit a compensation application. Finally, we believe that any potential prejudice to other carriers that have applied for compensation can be largely mitigated by proceeding with further payments of estimated compensation under the Act based on an estimate of the maximum number of revenue ton-miles (RTM) that could be reasonably claimed by both present and new applicants.

Accordingly, the Department hereby amends the final rule to allow an additional 7 calendar days from the date of this publication for indirect air carriers and wet lessors to submit a compensation application. However, we will adhere strictly to this new deadline. The Department will not accept late submissions unless an indirect air carrier or wet lessor demonstrates to the satisfaction of the Department that extremely unusual, extenuating circumstances, completely beyond its control, prevented it from making a timely submission and the Department determines that accepting the application is in the public interest.

Like all other applicants, indirect carriers and wet lessors (air carriers who provide “lift” to other air carriers under wet leases) applying under § 330.21(d), which is the section that contains the application deadline being extended today, should be careful to meet the documentation requirements of the regulations.

In administering the regulatory requirements, DOT is aware that the financial situations of some carriers may be extremely precarious, and that Congress intended they be afforded prompt action on their applications for relief. However, DOT must be scrupulous in assuring that public funds are disbursed in strict accord with statutory requirements. Thus, applicants should be aware that DOT will not process applications that fail to provide all of the information required. That information was set out in Part 330, and for all-cargo indirect air carriers and wet lessors, the data submission requirements of section 330.31 require particular attention.

A carrier that claims RTMs must document the RTMs generated for its own account, which was flown on its all-cargo flights, and it must identify the RTMs generated by other air carriers (under Aircraft, Crew, Maintenance, Insurance (ACMI) wet lease lift arrangements or other agreements). This information must be presented by carrier name and carrier code, with the number of RTMs clearly stated and segregated between RTMs generated by the claiming carrier and RTMs generated by other air carriers. Finally, applicants are again reminded that their applications must be accompanied by a certified statement, from the company's Chief Executive Officer, Chief Financial Officer, or Chief Operating Officer or, if those titles are not used, the equivalent officer, that the information was prepared under his or her supervision and is true and accurate under penalty of law. The claimant should also provide a similar certified statement from the other air carrier(s) stating that these RTMs were not claimed and will not be claimed by the other air carrier.

In meeting these requirements, applicants should especially ensure that written evidence is submitted that: (1) Demonstrates that the applicant meets the United States citizenship requirements to be an “air carrier” (49 U.S.C. § 40102); (2) clearly establishes the number of RTMs actually flown, segregated as necessary by the identity of the reporting carrier; (3) clearly establishes that the RTMs were generated on all-cargo flights only and not generated as “belly cargo” on combined passenger/cargo flights;1 and (4) clearly establishes, in writing, both the carrier's entitlement to the RTMs and that no other carrier has claimed or will claim the RTMs.

This rule is an economically significant rule under Executive Order 12886, since it will facilitate the distribution of more than a billion dollars into the economy during the 12-month period following its issuance. Because of the need to move quickly to provide compensation to air carriers for the purpose of maintaining a safe, efficient, and viable commercial aviation system in the wake of the events of September 11, 2001, we are not required to provide an assessment of the potential cost and benefits of this regulatory action. The Department has determined that this rule is being issued in an emergency situation, within the meaning of Section 6(a)(3)(D) of Executive Order 12866. However, this impact is expected to be a favorable one: making these funds available to air carriers to compensate them for losses resulting from the terrorist attacks of September 11th.

Because a notice of proposed rulemaking is not required for this rulemaking under 5 U.S.C. 553, we are not required to prepare a regulatory flexibility analysis under 5 U.S.C. 604. However, we do note that this rule may have a significant economic effect on a substantial number of small entities. Among the entities in question are many indirect air carriers, wet lessors and air taxis, as well as some commuters and small certificated air carriers. Inanalyzing small entity impact for purposes of the Regulatory Flexibility Act, we believe that, to the extent that the rule impacts small air carriers, the impact will be a favorable one, since it will consist of receiving compensation. We have facilitated the participation of small entities in the program by allowing a longer application period for indirect air carriers, wet lessors and air taxis, which are generally the smallest carriers covered by this rule and which generally do not otherwise report traffic or financial data to the Department. The Department has also concluded that this rule does not have sufficient Federalism implications to warrant the consultation requirements of Executive Order 13132.

We are making this rule effective immediately, without prior opportunity for public notice and comment. Because of the need to move quickly to provide compensation to air carriers for the purpose of maintaining a safe, efficient, and viable commercial aviation system in the wake of the events of September 11, 2001, prior notice and comment would be impractical, unnecessary, and contrary to the public interest. Consequently, prior notice and comment under 5 U.S.C. 553 and delay of the effective date under 5 U.S.C. 801,et seq., are not being provided. On the same basis, we have determined that there is good cause to make the rule effective immediately, rather than in 30 days.

The Office of Management and Budget has approved the information collection requirements of this rule, with Control Number 2105-0546.

Section 4(b)(1) of the Textile Fiber Products Identification Act (“Act”) declares that a textile product will be misbranded unless it is labeled to show, among other elements, the percentages, by weight, of the constituent fibers in the product, designated by their generic names and in order of predominance by weight. 15 U.S.C. 70b(b)(1). Section 4(c) of the Act provides that the same information required by section 4(b)(1) (except the percentages) must appear in written advertisements if any disclosure or implication of fiber content is made regarding a covered textile product. 15 U.S.C. 70b(c). Section 7(c) directs the Commission to promulgate such rules, including the establishment of generic names of manufactured fibers, as are necessary to enforce the Act's directives. 15 U.S.C. 70e(c).

Rule 6 of the Textile Rules requires manufacturers to use the generic names of the fibers contained in their textile fiber products in making required disclosures of the fiber content of the products. 16 CFR 303.6. Rule 7 sets forth the generic names and definitions that the Commission has established for synthetic fibers. 16 CFR 303.7. Rule 8 sets forth the procedures for establishing new generic names. 16 CFR 303.8.

On August 28, 2000, Cargill Dow applied to the Commission for a new fiber name and definition.1 Its application states that PLA fibers are synthetic but are derived from natural renewable resources (agricultural crops such as corn).2 It maintained that PLA can combine certain advantages of natural fibers with those of certain synthetic fibers. Cargill Dow contended that its proprietary Natureworks PLA fiber, and PLA that may be made using alternative processes, have unique properties that, along with PLA's unique fundamental chemistry, differentiate PLA fibers from all other recognized and listed synthetic or natural fibers.

Contending that the unique chemistry of fibers made from PLA is inadequately described under existing generic names listed in the Textile Rules, Cargill Dow petitioned the Commission to establish a new generic name and definition. After an initial analysis, the Commission announced, on October 30, 2000, that it had issued Cargill Dow the designation “CD 0001” for temporary use in identifying PLA fiber pending a final determination as to the merits of the application for a new generic name and definition. The Commission staff further analyzed the application, and on November 17, 2000 (65 FR 69486), the Commission published a Notice of Proposed Rulemaking (“NPR”) detailing the technical aspects of Cargill Dow's fiber, and requesting public comment on Cargill Dow's application. On January 29, 2001, the comment period closed.

In the NPR, the Commission solicited comment on whether Cargill Dow's application meets the Commission's three criteria for granting petitions for new generic names:

1. The fiber for which a generic name is requested must have a chemical composition radically different from other fibers, and that distinctive chemical composition must result in distinctive physical properties of significance to the general public.

2. The fiber must be in active commercial use or such use must be immediately foreseen.

3. The grant of the generic name must be of importance to the consuming public at large, rather than to a small group of knowledgeable professionals such as purchasing officers for large government agencies.3

In the NPR, the Commission noted that repeat units of PLA are linked by ester groups, which means that PLA fiber is a polyester. The Commission agreed with Cargill Dow, however, that PLA does not fit into Rule 7's current definition of polyester. Therefore, the Commission requested public comment on whether to: (1) Broaden Rule 7's definition of polyester to include PLA fiber; (2) create a separate subcategory and definition for PLA fiber within Rule 7's definition of polyester; or (3) add a new generic fiber name and definition to Rule 7 for PLA fiber.

The NPR provided a detailed description, taken from Cargill Dow's application, of PLA's chemical composition and physical and chemical properties.4 Cargill Dow explained that PLA fibers typically are made using lactic acid as the starting material for polymer manufacture. The lactic acid comes from fermenting various sources of natural sugars. These sugars can come from annually renewable agricultural crops such as corn or sugar beets. Cargill Dow maintained that PLA's fundamental polymer chemistry allows control of certain fiber properties and makes the fiber suitable for a wide variety of technical textile fiber applications, especially apparel and performance apparel applications. Of most significance to consumers, Cargill Dow maintained that PLA fibers exhibit: (1) Low moisture absorption and high wicking, offering benefits for sports and performance apparel and products; (2) low flammability and smoke generation; (3) high resistance to ultra violet (UV) light, a benefit for performance apparel as well as outdoor furniture and furnishings applications; (4) a low index of refraction, which provides excellent color characteristics; and (5) lower specific gravity, making PLA lighter in weight than other fibers. In addition to coming from an annually renewable resource base, Cargill Dow stated that PLA fibers are readily melt-spun, offering manufacturing advantages that will result in greater consumer choice.

In the NPR, the Commission proposed the following fiber name and definition for PLA, which Cargill Dow had suggested:

The NPR elicited eight comments, including one from Cargill Dow.5 Four commenters, Dystar UK Ltd, the National Corn Grower's Association, the Interface Research Corporation, and the Woolmark Company, as well as Cargill Dow, fully supported amending the Textile Rules to create a new, separate category in Rule 7 for PLA fiber and establishing a new generic fiber name and definition for Cargill Dow's fiber, as proposed by the Commission.6 Two other commenters supported creating a new name and definition for PLA fiber, but had comments about the name and definition proposed in the NPR, as discussed below. Only one commenter, FSA, opposed creating a new name and definition for PLA.

FSA stated that PLA's physical properties and processing behavior indicate that it should be regarded as merely an advanced type of polyester with several benefits for the environment. In the NPR, although the Commission noted that the repeat units of PLA are linked by ester groups like polyester fibers, the Commission tentatively concluded that PLA fiber did not fit into the current definition for polyester in Rule 7.7 PLA is an aliphatic polyhydroxycarboxylic acid, unlike other polyester fibers. In addition, PLA has a distinctly lower melting point and specific gravity than polyester fibers. It also appears to have better flame resistance qualities than polyester fibers. In light of PLA's unique chemical and physical properties, as well as seven other public comments, including the petitioner's, that supported creating a separate category in Rule 7 for PLA fiber, the Commission has determined not to amend the Rule to broaden the current definition for polyester in section 7(c) of the Rule to include PLA fiber.

With respect to the proposed name “synterra,” AFMA commented that as a result of two other commercial names now in use, consumer confusion could occur if the Commission adopted the proposed name. AFMA pointed out that “sontara” and “sensura” are trade names currently used by DuPont and Wellman Fibers, respectively, that apply to fibers, fabrics, and end-product uses similar to the anticipated uses for PLA fiber. The EC also commented that the proposed name, “synterra,” lacks sufficient reference to the chemical composition or physical properties of the fiber, and gives the impression of being a commercial trade name.

Finally, with respect to the new generic fiber definition, AFMA commented that the definition established by the Commission should be limited to a description of the fiber's chemical composition and should not include the method of manufacture.

The materials Cargill Dow submitted show that PLA fiber is based upon a distinctive chemical structure that is not encompassed by any existing definition in Rule 7. PLA's distinctive chemical structure results in a fiber that exhibits: low moisture absorption and high wicking, low flammability, high resistance to ultra violet light, a low index of refraction, and stability with respect to laundering and dry cleaning. In addition, the fiber comes from a renewable resource base. These properties are very important to those members of the general public who, for example, desire sports or performance apparel that is water-resistant and washable, or desire furnishings with low flammability. Thus, Cargill Dow's application meets this first criterion.

Cargill Dow's petition stated that fibers produced from PLA have been made into finished goods that are ready to commercialize, and several are in test markets. When it filed its petition, Cargill Dow was in the process of building a plant in Blair, Nebraska, capable of producing approximately 30 million pounds per year of PLA. Counsel for Cargill Dow has informed Commission staff that the plant soon will be operational. Such a level of production for distribution satisfies this second criterion.

The Commission agrees with Cargill Dow that the granting of a generic name to describe PLA is of importance to the general public, and not just a few knowledgeable professionals such as purchasing officers for large government agencies. A new generic name will enable consumers to identify textile fiber products containing PLA (such as sports and performance apparel) that exhibit significant water-resistance, softer feel or “hand,” elasticity, shape retention, and improved comfort. Thus, Cargill Dow's application satisfies this third criterion.

Based on the foregoing, the Commission finds that Cargill Dow's fiber, PLA, is of a distinctive chemical composition not encompassed by any of the Textile Rules' existing generic definitions for manufactured fibers, that its physical properties are important to the public, that the fiber is in active commercial use, and that the granting of a new generic name and definition is important to the consuming public at large.

In light of the comments it received, the Commission has determined to adopt the generic name “PLA” to identify Cargill Dow's new manufactured fiber. The name “PLA” is used throughout Cargill Dow's application to identify its Natureworks fiber, and there is a precedent in the Rule, namely “PBI,” for adopting an acronym as a generic fiber name (16 CFR 303.7(u)). In addition, the Commission is not aware of any other aliphatic hydroxycarboxylic acid derived polymer currently being used to manufacture textile fibers. Accordingly, to avoid consumer confusion, and in the absence of any other suggested generic fiber names from the commenters or the petitioner, the Commission has determined to designate the generic name “PLA” for Cargill Dow's Natureworks fiber.

Further, the Commission agrees that it would be inappropriate to include methods of manufacture in the new generic fiber definition of PLA. There is no precedent for doing so in section 303.7 of the Rule, and, in the Commission's view, including methods of manufacture in the generic fiber definition would unduly limit industry research and innovation. Therefore, as a logical outgrowth of the fiber definition proposed in the NPR, the Commission has determined to define PLA generically in terms of its chemical composition.

Accordingly, in light of the materials and information submitted by Cargill Dow, as well as the public comments received during this proceeding, the Commission amends Rule 7 of the Textile Rules by adding the following new name and definition for Cargill Dow's fiber: PLA. A manufactured fiber in which the fiber-forming substance is composed of at least 85% by weight of lactic acid ester units derived from naturally occurring sugars.8

The Commission is making the amendments effective on February 1, 2002, as permitted by 5 U.S.C. 553(d), because the amendments do not create new obligations under the Rule; rather, they merely create a fiber name and definition that the public may use to comply with the Rule.

In the NPR, the Commission tentatively concluded that the provisions of the Regulatory Flexibility Act relating to an initial regulatory analysis, 5 U.S.C. 603-604, did not apply to the proposal because the amendments, if promulgated, would not have a significant economic impact on a substantial number of small entities. The Commission believed that the proposed amendments would impose no additional obligations, penalties, or costs. The amendments simply would allow covered companies to use a new generic name for a new fiber that may not appropriately fit within current generic names and definitions, and would impose no additional labeling requirements. To ensure, however, that no substantial economic impact was overlooked, the Commission solicited public comment in the NPR on the effects of the proposed amendments on costs, profits, competitiveness of, and employment in small entities. 65 FR 69486, at 69491 (Nov. 17, 2000).

No comments were received on this issue. Accordingly, the Commission hereby certifies, pursuant to the Regulatory Flexibility Act, 5 U.S.C. 605(b), that the amendments promulgated today will not have a significant economic impact on a substantial number of small entities.

These amendments do not constitute “collection[s] of information” under the Paperwork Reduction Act of 1995, Pub. L. 104-13, 109 Stat. 163, 44 U.S.C. Chapter 35 (as amended), and its implementing regulations, 5 CFR 1320et seq.Those procedures for establishing generic names that do constitute collections of information, 16 CFR 303.8, have been submitted to OMB, which has approved them and assigned them control number 3084-0101.

On November 21, 1997, the Modernization Act (Public Law 105-115) was signed into law. Section 126 of the Modernization Act amended section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 353(b)(4)) to require, at a minimum, that, prior to dispensing, the label of prescription drugs bear the symbol “Rx only” instead of the statement “Caution: Federal law prohibits dispensing without prescription.” The new label statement may be printed as either “Rx only” or “℞ only.” Section 126 of the Modernization Act also repealed section 502(d) of the act (21 U.S.C. 352(d)), which provided that a drug or device containing certain enumerated narcotic or hypnotic (habit-forming) substances or their derivatives was misbranded unless its label bore the name and quantity of the substance and the statement “Warning—May be habit forming.” In theFederal Registerof April 21, 2000 (65 FR 21378), FDA proposed amending its regulations to implement these provisions of the Modernization Act.

The agency is finalizing without change the regulatory provisions of the proposed rule.

• The final rule amends parts 10, 201, 250, 310, 329, 361, 606, and 610 (21 CFR parts 10, 201, 250, 310, 329, 361, 606, and 610) by removing the requirement that prescription drugs be labeled with “Caution: Federal law prohibits dispensing without prescription” and adding in its place a requirement that prescription drugs be labeled with “Rx only” or “℞ only.”

• The final rule amends parts 201 and 369 (21 CFR part 369) by removing the requirement that certain habit-forming drugs bear the statement “Warning—May be habit forming.”

• The final rule removes part 329, Habit-Forming Drugs.

• The final rule amends part 290 (21 CFR part 290) by adding new §§ 290.1 and 290.2. Section 290.1 is being added to make clear the agency’s determination that a drug that is a controlled substance listed in schedule II, III, IV, or V of the Federal Controlled Substances Act (CSA) or implementing regulations must, unless otherwise determined by the agency, be dispensed by prescription only as required by section 503(b)(1) of the act. Section 290.2 retains the exemption from the prescription-dispensing requirement in § 329.20 for small amounts of codeine in combination with other nonnarcotic active medicinal ingredients.

The agency received three comments from pharmaceutical companies and one comment from an association of pharmacists.

(1). All four comments concerned the appearance of the “Rx only” statement on the label. In the proposed rule, the ℞ symbol appeared in bold because of type-setting limitations. FDA did not want to create the impression that it was proposing to require the ℞ symbol to appear in bold. In an attempt at clarification, a footnote was included in the proposed rule stating: “The ℞ symbol appears in bold in this document because of type-setting limitations, however, it should not be bolded when used on the product’s label” (65 FR 21378). Two comments objected to this apparent prohibition against the use of bolding, noting that the implementing guidance discussed in section IV of this document did not prescribe whether or not the ℞ symbol or the Rx only statement generally should appear in bold. FDA agrees with these comments. The ℞ symbol and the Rx only statement may be printed in bold or in regular type.

(2). In the implementing guidance, FDA stated: “The statement should be prominent and conspicuous, as is required by section 502(c) of the Act and 21 CFR 201.15.” One comment suggested that manufacturers should not be permitted to determine what placement on the label is prominent and conspicuous. The comment asked that FDA require that the Rx only statement appear on the main part of the label and also that FDA establish a minimum font size for the Rx only statement relative to the other text on the label.

FDA declines to adopt this suggestion. Section 502(c) of the act provides that a drug or device is misbranded if a label statement required by the act or FDA regulations * * * “is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” FDA’s regulation at § 201.15 elaborates on specific factors that could render a label statement not prominent and conspicuous. This regulation applies to the Rx only statement, and thus requirements specific to the Rx only statement are unnecessary.

(3). One comment objected to the agency’s position, expressed in the implementing guidance, that manufacturers are not prohibited from using the “Warning—May be habit forming” statement. The Modernization Act removed the requirement that the labels of habit-forming drugs bear this statement, but did not prohibit use of the statement. However, as explained inthe guidance, FDA believes that the habit-forming characteristics of a drug product should be adequately described in the “Drug Abuse and Dependence” section of the package insert and that further labeled warnings are not necessary.

A guidance for industry entitled “Implementation of Section 126 of the Food and Drug Administration Modernization Act of 1997—Elimination of Certain Labeling Requirements” (63 FR 39100, July 21, 1998) is available on the Internet at http://www.fda. gov/cder/guidance/index.htm or http://www.fda.gov/cber/ guidelines.htm. The guidance indicates that, for the time periods and under the circumstances stated below, in the exercise of its enforcement discretion, FDA does not intend to object if a sponsor does not comply with the new labeling requirements of section 126 of the Modernization Act. The guidance advises that FDA does not intend to object if sponsors of certain currently approved products implement the new requirements of section 126 of the Modernization Act at the time of the next revision of their labels, or by February 19, 2003, whichever comes first, and report these minor changes in the next annual report. For pending (unapproved) full or abbreviated applications received by the agency prior to February 19, 1998, sponsors should comply with the new labeling requirements by the time of the next revision of their labels or by February 19, 2003, whichever comes first. The guidance also advises that full or abbreviated applications received by FDA after February 19, 1998, should provide labels and labeling in compliance with the new labeling requirements.

The agency has determined under 21 CFR 25.30(k) that this action 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 final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 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. As described in section IV of this document, the agency’s guidance document explains that FDA will exercise its enforcement discretion in a manner that will permit companies to implement the required label changes at the time of the next revision of their labels, or by February 19, 2003, whichever comes first. Because almost all labels would typically be reprinted within this timeframe, this enforcement strategy will eliminate any significant costs that would otherwise be associated with the rule. As a result, the final rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options to minimize any significant impact of a rule on a substantial number of small entities. The agency certifies that the final rule would not have a significant impact on a substantial number of small entities because the lengthy implementation period will allow companies to make the necessary label changes during the normal course of business. Therefore, under the Regulatory Flexibility Act, no further analysis is required. Section 202(a) of the Unfunded Mandates Reform Act (Public Law 104-4) requires that agencies prepare an assessment of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year (adjusted annually for inflation). Because this rule does not impose any mandates on State, local, or tribal governments, or the private sector that will result in an expenditure of $100 million or more in any one year, FDA is not required to perform a cost-benefit analysis under the Unfunded Mandates Reform Act.

FDA concludes that this final rule does not require information collections subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (Public Law 104-13).

FDA is amending its labeling regulations by removing the requirement that prescription drugs be labeled with “Caution: Federal law prohibits dispensing without prescription” and adding a requirement that prescription drugs be labeled with “Rx only” or “℞ only.” This labeling statement is not subject to review by OMB because it is “originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)) and therefore does not constitute a “collection of information” under the PRA.

FDA has analyzed this final rule in accordance with Executive Order 13132: Federalism. Executive Order 13132 requires Federal agencies to carefully examine actions to determine if they contain policies that have federalism implications or that preempt existing State law. As defined in the Order, “policies that have federalism implications” refers to regulations, legislative comments or final legislation, and other policy statements or actions 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 revises FDA labeling regulations as required by the Modernization Act. Because enforcement of these labeling provisions is a Federal responsibility, there should be little, if any, impact from this rule 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. In addition, FDA does not believe that this final rule preempts any existing State law.

Accordingly, FDA has determined that this final rule does not contain policies that have federalism implications.

2. Section 10.50Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearingis amended by removing and reserving paragraph (c)(7).

4. Section 201.10Drugs; statement of ingredientsis amended in paragraph (a) by removing the phrase “as ‘Warning—May be habit forming’ ”.

5. Section 201.16 is revised to read as follows:

An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language. Such labeling is authorized under § 201.15(c). One required warning, the wording of which is fixed by law in the English language, could be translated in various ways, from literal translation to loose interpretation. The statutory nature of this warning requires that the translation convey the meaning properly to avoid confusion and dilution of the purpose of the warning. Section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act requires, at a minimum, that the label bear the statement “Rx only.” The Spanish-language version of this must be “Solamente Rx”.

6. Section 201.100Prescription drugs for human useis amended in paragraph (b)(1) by removing the phrase “ ‘Caution: Federal law prohibits dispensing without prescription’ ” and by adding in its place the phrase “ ‘Rx only’ ”.

7. Section 201.120Prescription chemicals and other prescription componentsis amended in paragraph (b)(2) by removing the phrase “ ‘Caution: Federal law prohibits dispensing without prescription’ ” and by adding in its place the phrase “ ‘Rx only’ ”.

8. Section 201.122Drugs for processing, repacking, or manufacturingis amended in the first sentence of the introductory text by removing the phrase “ ‘Caution: Federal law prohibits dispensing without prescription’ ” and by adding in its place the phrase “ ‘Rx only’ ”.

9. Section 201.306Potassium salt preparations intended for oral ingestion by manis amended in paragraph (b)(1) by removing the word “caution”.

11. Section 250.100Amyl nitrate inhalant as a prescription drug for human useis amended in paragraph (b) by removing the phrase “legend ‘Caution: Federal law prohibits dispensing without prescription.’ ” and by adding in its place the phrase “statement ‘Rx only.’ ”.

12. Section 250.101Amphetamine and methamphetamine inhalers regarded as prescription drugsis amended in paragraph (b) by removing the phrase “legend ‘Caution: Federal law prohibits dispensing without prescription.’ ” and by adding in its place the phrase “statement ‘Rx only.’ ”.

13. Section 250.105Gelsemium-containing preparations regarded as prescription drugsis amended in the last sentence by removing the phrase “ ‘Caution: Federal law prohibits dispensing without prescription.’ ” and by adding in its place the phrase “ ‘Rx only.’ ”.

14. Section 250.108Potassium permanganate preparations as prescription drugsis amended in paragraph (c)(1) by removing the phrase “legend, ‘Caution: Federal law prohibits dispensing without prescription.’ ” and by adding in its place the phrase “statement ‘Rx only.’ ” and in paragraph (c)(2) by removing the phrase “, ‘Caution: Federal law prohibits dispensing without prescription.’ ” and by adding in its place the phrase “ ‘Rx only.’ ”.

15. Section 250.201Preparations for the treatment of pernicious anemiais amended in paragraph (d) by removing the phrase “legend ‘Caution—Federal law prohibits dispensing without prescription.’ ” and by adding in its place the phrase “statement ‘Rx only.’ ”.

16. Section 250.250Hexachlorophene, as a component of drug and cosmetic productsis amended in the last sentence of paragraph (c)(1) by removing the phrase “legend ‘Caution: Federal law prohibits dispensing without a prescription,’ ” and by adding in its place the phrase “statement ‘Rx only,’ ” and in paragraph (c)(4)(i) by removing the phrase “prescription legend” and by adding in its place the phrase “statement ‘Rx only’ ”.

Any drug that is a controlled substance listed in schedule II, III, IV, or V of the Federal Controlled Substances Act or implementing regulations must be dispensed by prescription only as required by section 503(b)(1) of theFederal Food, Drug, and Cosmetic Act unless specifically exempted in § 290.2.

The prescription-dispensing requirements of section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act are not necessary for the protection of the public health with respect to a compound, mixture, or preparation containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams that also includes one or more nonnarcotic active medicinal ingredients in sufficient proportion to confer upon the compound, mixture, or preparation valuable medicinal qualities other than those possessed by codeine alone.

21. Section 310.103New drug substances intended for hypersensitivity testingis amended in paragraph (a)(3)(i) by removing the phrase “ ‘Caution: Federal law prohibits dispensing without a prescription’ ” and by adding in its place the phrase “ ‘Rx only’ ”.

24. Section 341.14Antitussive active ingredientsis amended in paragraph (a)(2) by removing “§§ 329.20(a) and 341.40” and by adding in its place “§ 290.2”.

26. Section 361.1Radioactive drugs for certain research usesis amended in paragraph (f)(1) by removing the phrase “ ‘Caution: Federal law prohibits dispensing without prescription’ ” and by adding in its place the phrase “ ‘Rx only’ ”.

28. Section 369.22 is removed.

30. Section 606.121 is amended by revising paragraph (c)(8)(i) to read as follows:

This document contains amendments to the Income Tax Regulations (26 CFR Part 1) under § 1.1031(k)-1. On January 17, 2001, the IRS and Treasury Department published in theFederal Registera notice of proposed rulemaking under section 1031 (66 FR 3924). The notice proposed to amend § 1.1031(k)-1(k) by narrowing the definition of the termdisqualified person.Comments responding to the notice were received, and a public hearing was held on June 5, 2001. After considering the comments received in response to the notice of proposed rulemaking and the statements made at the public hearing, the proposed regulations are adopted as revised by this Treasury decision. The comments and revisions are discussed below.

Under section 1031 and the regulations thereunder, taxpayers may use a qualified escrow account, qualified trust, or qualified intermediary to facilitate a like-kind exchange. A requirement common to qualified escrow accounts, qualified trusts, and qualified intermediaries is that the escrow holder, trustee, or intermediary may not be the taxpayer or a disqualified person.

Section 1.1031(k)-1(k) defines a disqualified person to include an agent of the taxpayer at the time of the transaction. An agent includes a person that has acted as the taxpayer's employee, attorney, accountant, investment banker or broker, or real estate agent or broker within two years of the taxpayer's transfer of relinquished property. However, in determining whether a person is a disqualified person, services provided by such person for the taxpayer with respect to section 1031 exchanges of property and routine financial, title insurance, escrow, or trust services provided to the taxpayer by a financial institution, title insurance company, or escrow company are not taken into account. Under § 1.1031(k)-1(k)(4), a person that is related to a disqualified person, determined by using the attribution rules of sections 267(b) and 707(b), but substituting 10 percent for 50 percent, is also considered a disqualified person.

As a consequence of the Gramm-Leach-Bliley Act, Public Law 106-102 (Nov. 12, 1999), 113 Stat. 1341, and other changes in policy by the Federal Reserve System in recent years, many banks are, or are in the process of becoming, members of controlled groups that include investment banking and brokerage firms. These new relationships between banks and investment banking and brokerage firms may make it difficult for some banks to continue their traditional practices of providing qualified escrow, qualified trust, and qualified intermediary services without violating the disqualified person rules. To allow banks to continue to perform these services, the proposed regulations provide that a bank that is a member of a controlled group that includes an investment banking or brokerage firm as a member will not be a disqualified person merely because the related investment banking or brokerage firm provided services to an exchange customer within a two-year period ending on the date of the transfer of the relinquished property by that customer.

Treasury and the IRS received several comments on the proposed regulations. Some commentators argued that the proposed exception to the disqualified person rules would not fulfill its intended purpose, because most banks use non-bank subsidiaries or affiliates to serve as escrow holders of qualified escrow accounts, trustees of qualified trusts, or qualified intermediaries. These commentators recommended that the proposed exception be extended to apply to subsidiaries and affiliates of banks. In response to these comments, the final regulations extend the proposed exception to bank affiliates as well as banks. For this purpose, a bank affiliate is a non-bank corporation whose principal activity is rendering services to facilitate exchanges of property intended to qualify for nonrecognition of gain under section 1031 and all of whose outstanding stock is owned by either a bank or a bank holding company (within the meaning of section 2(a) of the Bank Holding Company Act of 1956, 12 U.S.C. 1841(a)).

Some commentators noted the discrepancy between the effective date set forth in the text of the proposed regulations (i.e., applicable to transfers of relinquished property on or after the date of the final regulations) and the effective date set forth in the Preamble to those regulations (i.e., applicable to transfers of relinquished property on or after January 17, 2001). In response to the comments, the final regulations adopt the earlier of the two effective dates, and thus apply in the case of transfers of relinquished property made by a taxpayer on or after January 17, 2001.

Other commentators expressed opposition to the proposed regulations, requesting that the regulations be withdrawn. The commentators maintained that the existing regulations provide adequate exceptions to the definition of disqualified person, and that an exception for the banking industry will erode the integrity and purpose of the disqualified person concept.

Treasury and the IRS continue to believe that the amendment to the regulations is appropriate and necessary for the reasons articulated in the Preamble to the proposed regulations. Banks and their affiliates are closely regulated institutions that have historically acted as neutral and independent holders of funds. Treasury and the IRS do not believe that recent changes to federal banking laws are likely to impinge on this role to any significant degree.

Finally, one commentator requested that the final regulations include the exception from the disqualified person rule set forth in section 3.03 of Rev. Proc. 2000-37 (2000-40 I.R.B. 308). Rev. Proc. 2000-37, published to facilitate reverse like-kind exchanges, provides a safe harbor for the qualification under section 1031 of certain arrangements between taxpayers and exchange accommodation titleholders and provides for the treatment of the exchange accommodation titleholder as the beneficial owner of the property for federal income tax purposes. Section 3.03 of the revenue procedure provides that services performed for the taxpayer in connection with a person's role as the exchange accommodation titleholder are not taken into account in determining whether that person or a related person is a disqualified person. Treasury and the IRS do not believe that this rule needs to be restated in these regulations. Consequently, the final regulations do not include the exception from the disqualified person rule set forth in Rev. Proc. 2000-37.

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because these regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of the regulations is Brendan O'Hara, Office of Associate Chief Counsel (Income Tax and Accounting). However, other personnel from the IRS and Treasury Department participated in the development of the regulations.

The I M Rail Link Railroad requested a temporary deviation on December 20, 2001 from the drawbridge operation regulations to allow the bridge owner time for preventative maintenance. The drawbridge operation regulations require that the drawbridge open on signal.

The Sabula Railroad Drawbridge provides a vertical clearance of 18.1 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This deviation has been coordinated with waterway users. There were no objections.

This deviation allows the bridge to remain closed to navigation from 12:01 a.m., January 20, 2002 to 12:01 a.m., March 11, 2002 with openings provided upon receipt of twenty-four (24) hours advance notice.

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 a NPRM. Publishing a NPRM and delaying the rule's effective date would be contrary to the public interest since immediate action is needed to protect the public, ports and waterways of the United States. TheCoast Guard will issue a broadcast notice to mariners and a Marine Safety Information Bulletin via facsimile and electronic mail to advise mariners of the restriction.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register.

Based on the September 11, 2001, terrorist attacks on the World Trade Center buildings in New York and the Pentagon in Arlington, Virginia, there is an increased risk that subversive activity could be launched by vessels or persons in close proximity to the Port of Charlotte Amalie, U.S. Virgin Islands (USVI) against cruise ships in the Port.

Due to the number of passengers onboard cruise ships while moored in the Port of Charlotte Amalie, USVI, there is a risk that they are a target for subversive activity or a terrorist attack. The Captain of the Port San Juan is reducing this risk by prohibiting all vessels from coming within 50 yards of cruise ships while entering, departing, moored at any pier, or anchored in any anchorage in the Port of Charlotte Amalie, St. Thomas, USVI unless prior authorization is given by the Captain of the Port of San Juan. These temporary security zones are activated when cruise ships pass: St. Thomas Harbor green lighted buoy #3 in approximate position 18°19′19″ North, 64°55′40″ West when entering the port using St. Thomas Channel; red buoy #2 in approximate position 18°19′15″ North, 64°55′59″ West when entering the port using East Gregorie Channel; and red lighted buoy #4 in approximate position 18°18′16″ North, 64°57′30″ West when entering the port using West Gregorie Channel. These zones are deactivated when the vessel passes any of these buoys on its departure from port. United States Coast Guard and territorial law enforcement personnel will be enforcing these security zones.

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) because the zones are narrow in scope and are only in effect for limited periods of time when a cruise ship is in Port.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic effect upon a substantial number of small entities. “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. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because the zones are narrow in scope and are only in effect for limited periods of time when a cruise ship is in Port. Moreover, vessels may be allowed to enter the zones on a case-by-case basis with the permission of the Captain of the Port of San Juan.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offer 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 underFOR FURTHER INFORMATION CONTACTfor 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 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 requirements under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

A rule has implication 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

This rule will not effect 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.

The Coast Guard has considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M14475.1D that this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated underADDRESSES.

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 relationships 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 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 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 a NPRM. Publishing a NPRM and delaying the rule's effective date would be contrary to the public interest since immediate action is needed to protect the public, ports and waterways of the United States. The Coast Guard will issue a broadcast notice to mariners to advise mariners of the restriction.

For the same reasons, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in theFederal Register.

Due to the highly volatile nature of the substances stored at the HOVENSA facility, there is a risk that subversive activity could be launched by persons aboard commercial tank and freight vessels calling at the HOVENSA facility in St Croix, USVI. The Captain of the Port San Juan is reducing this risk by prohibiting all persons aboard these vessels from disembarking while moored at the HOVENSA facility unless escorted by designated HOVENSA personnel or specifically permitted by the Captain of the Port San Juan. HOVENSA security personnel, in conjunction with local police department personnel, will be present to enforce this security zone. A security zone regulation for the same location was published in theFederal Registeron September 28, 2001 (66 FR 49534). However, that regulation expired at 11:59 p.m. on October 15, 2001. We extended this security zone in CGD07-01-125 until December 31, 2001. The Captain of the Port San Juan has identified the need to keep a security zone in place for national security reasons and to protect the public and the port of HOVENSA from potential subversive acts.

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 andBudget 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) because this rule is in effect for a limited time and crewmember may be allowed to disembark when escorted by designated HOVENSA security or authorized by the Captain of the Port of San Juan.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), the Coast Guard considered whether this rule would have a significant economic effect upon a substantial number of small entities. “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. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities because persons may be allowed to disembark the vessels on a case by case basis with the authorization of the Captain of the Port and this temporary rule is only in effect for a limited time.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer 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 underFOR FURTHER INFORMATION CONTACTfor 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 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 requirements under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

A rule has implication 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 an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

The Coast Guard has considered the environmental impact of this rule and will prepare a categorical exclusion as per Figure 2-1, paragraph 34(g) of the Coast Guard NEPA Implementing Procedures, Commandant Instruction M16475.1D.

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 relationships 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 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.

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

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 the table could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the person listed underFOR FURTHER INFORMATION CONTACT.

1.Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations”, “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to theFederal Registerlistings at http://www.epa.gov/fedrgstr/. To access the Office of Prevention, Pesticides, and Toxic Substances (OPPTS) Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2.In person. The Agency has established an official record for this action under docket control number OPP-301206. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In theFederal Registerof April 18, 2001; (66 FR 19935) (FRL-6777-4), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the FQPA of 1996 (Public Law 104-170) announcing the filing of a pesticide petition (PP 0F6108) for tolerance by Uniroyal Chemical Company, Benson Road, Middlebury, CT 06749. This notice included a summary of the petition prepared by Uniroyal Chemical Company, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing a tolerance for residues of the insecticide bifenazate in or on the raw agricultural commodities apple, wet pomace at 1.2 parts per million (ppm); cotton seed at 0.5 ppm; cotton, gin byproducts (gin trash) at 20 ppm; fruit, pome, group at 0.75 ppm; fruit, stone, group (except cherries) at 1.5 ppm; grape at 0.75 ppm; hop at 15 ppm and strawberry at 1.5 ppm. As cotton processed commodities fed to animals may be transferred to milk and edible tissue of ruminants, tolerances were also proposed for meat at 0.02 ppm and milk at 0.01 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 EPAdetermines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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) 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 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), 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), for tolerances for combined residues of bifenazate and D3598 (expressed as bifenazate) in or on apple, wet pomace at 1.2 ppm; cattle, fat at 0.1 ppm; cotton, gin byproducts at 35 ppm; cotton, undelinted seed at 0.75 ppm; fruit, pome, group at 0.75 ppm; goat, fat at 0.1 ppm; grape at 0.75 ppm; grape, raisin at 1.2 ppm; hog, fat at 0.1 ppm; hop, dried cones at 15 ppm; horse, fat at 0.1 ppm; nectarine at 1.7 ppm; peach at 1.7 ppm; plum at 0.3 ppm; sheep, fat at 0.1 ppm; strawberry at 1.5 ppm and combined residues of bifenazate and D3598 (expressed as bifenazate), A1530 and A1530-sulfate (expressed as A1530) in: cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.01 ppm; hog, meat at 0.01 ppm; hog, meat byproducts at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep, meat at 0.01 ppm; sheep, meat byproducts at 0.01 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 bifenazate are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (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 intra species variations.

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 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 Safety Factor.

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 variations) 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- 6or 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 bifenazate used for human risk assessment is shown in the following Table 2:

1.Dietary exposure from food and feed uses. Tolerances have been established 40 CFR 180.572 for the combined residues of bifenazate and D3598 (expressed as bifenazate) in or on raw agricultural commodities and animal fat and combined residues of bifenazate, D3598 (expressed as bifenazate), A1530 and A1530-sulfate (expressed as A1530) in animal tissues (excluding fat) and milk. Risk assessments were conducted by EPA to assess dietary exposures from bifenazate in food as follows:

i.Acute exposure. The Agency did not identify an acute endpoint for the general population, infants, children, and females 13 to 50 years old. Therefore, an acute dietary exposure analysis is not necessary.

ii.Chronic exposure. A chronic dietary exposure analysis was conducted using the Dietary Exposure Evaluation Model (DEEM® ver 7.73) which incorporates consumption data from the USDA 1989-92 Continuing Surveys of Food Intake by Individuals (CSFII). The dietary exposure analysis assumed tolerance level residues and 100% crop treated for all registered and proposed crops. Processing factors for apple juice and grape juice were reduced to 0.23 and 0.17, respectively. The DEEM® default processing factor ratio between juice and concentrate was maintained and default processing factors were assumed for all other commodities.

There is a Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) sec 18 registration for application of bifenazate to greenhouse grown tomatoes. The potential for fresh market tomatoes to enter the processed market channel from this use is minimal for the following reasons: (a) this sec 18 approval will treat only about 300 acres of greenhouse grown tomatoes in Colorado, Texas and Virginia, (b) the tomato variety grown is an indeterminant type unsuitable for processing due to less solids and higher water content, (c) fresh market tomatoes do not tolerate the bulk handling required for processing, (d) higher price for fresh tomatoes would dictate the growers not to divert greenhouse grown tomatoes to the processing market. Therefore, the dietary contribution of bifenazate residues from treated tomatoes was determined to be negligible and a zero residue in/on tomatoes was assumed for this action.

The chronic dietary food exposure estimates to bifenazate were less than The Agency 's level of concern (100% cPAD) for the general U.S. population and all population subgroups. The most highly exposed population was infants (1 year) at 52% of the cPAD.

iii.Cancer. The Agency classified bifenazate as “not likely” to be a human carcinogen according to EPAProposed Guidelines for Carcinogen Risk Assessment(April 10, 1996). Therefore, a cancer dietary exposure analysis is not necessary.

2.Dietary exposure from drinking water. The available environmental fate data indicate that bifenazate may not persist in the environment nor have the ability to leach into ground water resources. Bifenazate dissipates quickly through metabolic processes under aerobic soil conditions (with a half-life of 30 minutes), by aqueous photolysis (half-life of 0.67 day), and by hydrolysis, especially in alkaline water (half-life of 0.08 day). In neutral and acidic water systems, bifenazate may persist for approximately one day or longer (half-lives of 0.8 day at pH 7, and 5.4 days in pH 5). Although photodegradation of bifenazate in soil may be possible, it could not be confirmed in the laboratorydue to rapid biodegradation of bifenazate under aerobic soil conditions. In the laboratory soil column studies, bifenazate showed low to no mobility in the soils tested.

Two major degradates of bifenazate were identified in the aqueous photolysis and aerobic soil metabolism studies D3598 (diazinecarboxylic acid, 2-(4-methoxy-1,1'-biphenyl]-3-yl), 1-methylethylester) and D1989 (4-methoxybiphenyl). Similar to parent bifenazate, D3598 seemed to metabolize quickly under aerobic soil conditions (half-life of 8.3 hours). D1989 on the other hand, is believed to be more persistent and have some potential to leach into the ground water resources. D1989 has an aerobic soil metabolism half-life of 60 days and was observed to have slight mobility in laboratory leaching studies. D1989 was the only degradate of bifenazate detected in terrestrial field dissipation studies, but only the 0 - 6 inches soil depth.

Since parent bifenazate and its degradate D3598 are not persistent in the environment and since there are no acute dietary endpoint data for these compounds, the Agency has decided not to consider bifenazate and D3598 as residues of concern in drinking water. Instead, D1989 was assumed to have the possible potential to contaminate the drinking water resources.

The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for bifenazate 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 bifenazate.

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentration in Ground Water (SCI-GROW) model is used to predict pesticide concentrations in shallow groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, 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 %RfD or %PAD. 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 bifenazate they are further discussed in the aggregate risk sections below.

Based on the FIRST or PRZM/EXAMS and SCI-GROW models the estimated environmental concentrations (EECs) of D1989 for acute exposures are estimated to be 18 parts per billion (ppb) for surface water and less than 1 part per trillion (ppt) for ground water. The EECs for chronic exposures are estimated to be 5 parts per billion (ppb) for surface water and1 ppt for ground water. These concentrations were based on one application of bifenazate on hops at a maximum rate of 0.75 lb ai/acre/year, and on the assumption that bifenazate totally metabolizes and degrades to D1989.

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). The currently registered Floramite® (EPA Reg. No. 400-481) and the proposed new product for food uses (Acramite®; EPA File Symbol: 400 LNG) of bifenazate are not expected to result in residential exposures. The Floramite® label allows application of bifenazate to landscape ornamentals at residential/recreational sites by commercial applicators only. The Acramite® label specifies agricultural use only. Therefore, this action assumes that bifenazate products will not be used by homeowners, so no homeowner exposure assessment is included. With respect to post-application residential exposures, the Agency contends that no significant post-application exposure is anticipated from treated ornamentals, either by residents or professional applicators; therefore, no residential post-application assessment is warranted.

4.Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) 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 bifenazate 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, bifenazate 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 bifenazate 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. FFDCA section 408 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 margin of exposure (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 qualitative or quantitative toxicity evidence of increased susceptibility of rats and rabbits during in uteroexposure or during post-natal exposure based on developmental toxicity and reproductive toxicity studies performed with bifenazate.

3.Conclusion. There is a complete toxicity database for bifenazate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Based on the lack of increased susceptibility and the completeness of the toxicity and exposure databases, EPA has concluded that an additional 10X safety factor is not needed to protect infants and children.

Because The Agency does not have ground and surface water monitoring data to calculate a quantitative aggregate exposure, DWLOCs were calculated. A DWLOC is a theoretical upper limit on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, drinking water, and through residential uses. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, body weights, and pesticide uses. Different populations will have different DWLOCs. The Agency uses DWLOCs in the risk assessment process to assess potential concern for exposure associated with pesticides in drinking water. DWLOC values are not regulatory standards for drinking water. The Agency compares DWLOC values for each relevant population subgroup to the estimated concentration of bifenazate in surface water and ground water from the Agency' screening models. If the DWLOC values are greater than the estimated concentration of bifenazate in surface water and ground water, The Agency concludes with reasonable certainty that exposures to bifenazate in drinking water do not pose a significant human health risk.

To calculate the chronic DWLOCs, the food estimates (from DEEM®) were subtracted from the appropriate PAD value to obtain the maximum water exposure level. DWLOCs were then calculated using the standard body weights and drinking water consumption figures: 70kg/2L (adult male and U.S. population), 60 kg/2L (adult female), and 10kg/1L (infants and children). Because there is no residential exposure to bifenazate, only chronic aggregate exposures are necessary.

1.Acute risk. The Agency did not identify an acute endpoint for the general U.S. population, infants, children, and females 13-50 years old. Therefore, an acute risk is expected.

2.Chronic risk. The chronic dietary food exposure to bifenazate was estimated at 0.005242 mg/kg/day (52% of cPAD) for infants (1 year old) and 0.001557 mg/kg/day (16% of cPAD) for the general U.S. population. The calculated DWLOCs ranged between 48 to 320 ppb for all the population subgroups. The surface and ground water chronic EECs for the bifenazate metabolite D1989 were estimated to be 5 ppb and1 part per trillion (ppt), respectively. Since the chronic EECs are less than the Agency's DWLOCs for all population subgroups including infants, the chronic aggregate risk estimates are below the Agency's level of concern. Table 3 summarizes the chronic aggregate exposure to bifenazate.

3.Short-term risk. A short term risk assessment was not performed because there are no significant exposures anticipated from registered residential non-food uses of bifenazate.

4.Intermediate-term risk. An intermediate term risk assessment was not performed because there are no significant post-application exposures anticipated from registered residential non-food uses of bifenazate.

5.Aggregate cancer risk for U.S. population. Bifenazate is not carcinogenic.

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 bifenazate residues.

The analytical methods used in the field trial, processing, and ruminant feeding have been adequately validated and are appropriate for data gathering purposes. The following paragraphs pertain to the proposed plant and livestock enforcement methods.

1.Plant. The method proposed for enforcement of the plant tolerancesassociated with this petition has been adequately radiovalidated and validated by an independent laboratory. The Agency's Analytical Chemistry Laboratory (ACL) is currently doing a Petition Method Validation (PMV). After reviewing the independent validation, EPA believes that the PMV will at most show that relatively minor modifications or revisions may need to be made. The registrant will be required to make any modifications or revisions to the proposed enforcement method resulting from the PMV.

2.Livestock. The method proposed for enforcement of the animal product tolerances associated with this petition has been adequately validated by an independent laboratory. The independent laboratory validation study resulted in marginal recoveries for bifenazate (milk and kidney), D3598 (liver), and A1530-sulfate (kidney). A radiovalidation of the method was not undertaken by the registrant, as the total radioactive bifenazate and its metabolite residues were very low for analytical purposes. However, the analytical method used for quantifying residues in animal tissues were satisfactorily validated on freshly spiked matrices. The ACL is currently doing a PMV. After reviewing the independent validation, EPA believes that the PMV will at most show that relatively minor modifications or revisions may need to be made. The registrant will be required to make any modifications or revisions to the proposed enforcement method resulting from the PMV.

3.Multiresidue method (MRM). The registrant submitted data concerning the recovery of bifenazate and D3598 using FDA multiresidue method protocols A, C, D, E, and F (Pesticide Analytical Manual Vol. I). Acceptable results were only attained using Protocol C. These data were forwarded to FDA for inclusion in the Pesticide Analytical Manual I. The tolerance expression for livestock commodities includes A1530 and A1530-sulfate. The registrant should submit information concerning the behavior of these compounds through the FDA multiresidue protocols.

Adequate enforcement methodology (utilizing reversed phase high pressure liquid chromatography (HPLC) and oxidative coulometric electrochemical detection) is available to enforce the tolerance expression. The method may be requested from: Francis Griffith, Analytical Chemistry Branch, Environmental Science Center, Environmental Protection Agency, 701 Mapes Road, Fort George G. Mead, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: griffith.francis@epa.gov. In addition, Mulitresidue Enforcement Method, Protocol C, has been shown to be adequate for enforcing these tolerances.

There is neither a CODEX proposal, nor Canadian or Mexican limits for residues of bifenazate and D3598 in/on pome fruit, stone fruit, strawberry, hops, cotton, or grape or for resides of bifenazate, D3598, A1530 and A1530-sulfate in/on livestock commodities. Therefore, harmonization is not an issue for this pesticide tolerance.

The submitted residue chemistry and toxicological studies are adequate for a conditional registration of bifenazate for food uses. There is high confidence in the hazard end points used for human health risk assessment. However, the following data are being required within 2 years time in order to confirm the results of the studies already reviewed by the Agency and/or to complete the database requirements prior to approval of an unconditional registration of bifenazate:

a. Confirmatory method and interference study for proposed plant and livestock enforcement.

b. Radio validation of proposed livestock enforcement method.

c. FDA multi residue methods testing of A1530 and A1530-sulfate.

d. Storage stability data for hops, strawberry, apple juice, and wet apple pomace.

e. Additional peach field trial data.

f. Additional plum field trial data.

g. Additional grape field trial data.

h. Additional cotton field trial data.

i. 28-day inhalation toxicity study. This study was requested by the Agency for further characterization of inhalation risk assessments. Due to the potential for inhalation exposure, there is concern for toxicity by the inhalation route. The 28-day inhalation toxicity study would give a dose and endpoint examined via the route of exposure of concern (i.e., route specific study) and thus would avoid using an oral study and route-to-route extrapolation. The protocol for the existing 90-day inhalation toxicity study (OPPTS 870.3465) should be followed with the exposure (treatment) ending after 28 days, instead of 90 days.

The rationale for not requiring these data before registration of food uses are provided below:

1.Deficiencies a, b and c. Adequate analytical methods are available for enforcement purposes. These methods were independently validated and a petition method validation is in progress at the Agency's Analytical Chemistry Laboratory. In addition, a Mulitresidue Enforcement Method, Protocol C, has been shown to be adequate for enforcing these tolerances.

2.Deficiencies d through h. The storage interval of almost all commodity samples collected from the field trial and processing have been validated. The storage interval for hops, strawberry, apple juice, and wet apple pomace were not validated as required and are necessary to confirm the submitted residue chemistry data. The Agency concluded that the interval from sampling until analysis was reasonable and will not invalidate the submitted data due to lack of stability of bifenazate residues of concern. For peach, plum, grape and cotton, the requirements are additional field trials to fulfil the geographical distribution and also to confirm the data already submitted and reviewed by the Agency. The crops and number of trials required are peach(2), plum(1), grape(1) and cotton(1).

3.Deficiency i. Bifenazate is not acutely toxic by oral, dermal or inhalation routes (Toxicity category IV). Because of low inhalation toxicity, the registrant did not do a subchronic inhalation toxicity and its absence, the Agency used for endpoint selection the oral NOAELs for short-, intermediate- and long-term inhalation exposure risk assessment for this action. To fully characterize the toxicity potential by inhalation route of exposure over long term use of bifenazate, a 28-day inhalation study is required.

Therefore, the tolerances are established for combined residues of bifenazate and D3598 (expressed as bifenazate) in or on apple, wet pomace at 1.2 ppm; cattle fat at 0.1 ppm; cotton, undelinted seed at 0.75 ppm; cotton, gin byproducts at 35 ppm; fruit, pome, group at 0.75 ppm; goat fat at 0.1 pm; grape 0.75 ppm; grape, raisin at 1.2 ppm; hog fat at 0.1 ppm; hop, dried cones at 15 ppm; horse fat at 0.1 ppm; nectarine at 1.7 ppm; peach at 1.7 ppm; plum at 0.30 ppm; sheep fat at 0.1 ppm strawberry at 1.5 ppm and combined residues of bifenazate, D3598 (expressed a bifenazate), A1530 and A1530-sulfate (expressed as A1530) in cattle meat at 0.01 ppm; cattle meat byproducts at 0.01 ppm; goat meat at 0.01 ppm; goat meat byproducts at 0.01 ppm; hog meat at 0.01 ppm; hog meat byproducts at 0.01 ppm; horse meat at 0.01 ppm; horse meat byproducts at 0.01 ppm; milk at 0.01 ppm; sheep meat at 0.01 ppm; and sheep meat byproducts at 0.01 ppm.

Some of the tolerance values requested by the registrant in their petition are different from thatdetermined by the Agency. The differences are due to the following reasons: The registrant requested a group tolerance for stone fruits. This is not appropriate at this time as no field trial data were submitted on cherry and apricot and/or the maximum peach (1.45 ppm) and plum (0.15 ppm) residue varied by a factor5x. In the case of undelinted cotton seeds and cotton gin byproducts, the Agency concluded that a higher tolerance of 0.75 ppm and 35 ppm are required as compared with 0.5 ppm and 20 ppm, respectively, for the combined residues of bifenazate and D3598 (expressed as bifenazate) due to the correction factors applied to the percent recoveries of residues for concern in the storage stability study. For meat of cattle, goat, hog, horse and sheep the registrant requested a 0.02 ppm tolerance; however, the Agency concluded that the bifenazate level used in the animal feeding study (maximum theoretical dietary burden) supports only 0.01 ppm for the combined residues of bifenazate, D3598 (expressed as bifenazate), A1530 and A1530-sulfate (expressed as A1530).

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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) 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 FFDCA sections 408 and 409. 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 control number OPP-301206 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 2, 2002.

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 (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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 (202) 260-4865.

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.

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.

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.2. Mail your copies, identified by docket control number OPP-301206, 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. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. 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 FFDCA section 408(d) 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, entitledRegulatory 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 notcontain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et 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, entitledFederal 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, entitledProtection 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 FFDCA section 408(d), 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. 601et 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, entitledFederalism(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 FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitledConsultation 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. 801et 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 theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

This amendment provides the tax tables necessary to compute the relocation income tax (RIT) allowance for employees who are taxed in 2002 on moving expense reimbursements.

Section 5724b of Title 5, United States Code, provides for reimbursement of substantially all Federal, State, and local income taxes incurred by a transferred Federal employee on taxable moving expense reimbursements. Policies and procedures for the calculation and payment of a RIT allowance are contained in the Federal Travel Regulation (41 CFR part 302-11). The Federal, State, and Puerto Rico tax tables for calculating RIT allowance payments are updated yearly to reflect changes in Federal, State, and Puerto Rico income tax brackets and rates.

The General Services Administration (GSA) has determined that this final rule is not a significant regulatory action for the purposes of Executive Order 12866 of September 30, 1993.

This final rule is not required to be published in theFederal Registerfor notice and comment; therefore, the Regulatory Flexibility Act, 5 U.S.C. 601et seq., does not apply.

The Paperwork Reduction Act does not apply because this final rule does not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors, or members of the public which require the approval of the Office of Management and Budget under 44 U.S.C. 3501et seq.

This final rule is also exempt from Congressional review prescribed under 5 U.S.C. 801 since it relates solely to agency management and personnel.

For the reasons set forth in the preamble, 41 CFR part 302-11 is amended as follows: