SBA has received requests from the public to review the size standard for the Arrangement of Transportation of Freight and Cargo industry (Standard Industrial Classification (SIC) code 4731). In particular, these requests express a concern about the method in which average annual receipts are calculated for Freight Forwarders and Custom Brokers within this industry. In response to those requests, on July 26, 1999, SBA published a proposed rule to revise the size standard for the Arrangement of Transportation of Freight and Cargo industry from $18.5 million to $5.0 million. (See 64 FR 40314.) The rule also proposed to revise the way average annual receipts are calculated to exclude pass-through of funds held in trust for unaffiliated third parties.

SBA proposed this size standard based on its analysis of the latest available U.S. Bureau of the Census (the Census Bureau) industry data for SIC 4731 and Federal contract award data from the Federal Procurement Data Center. SBA evaluated certain factors describing the economic characteristics of firms in the Arrangement of Transportation of Freight and Cargo industry. These factors were average firm size, the distribution of industry revenues by size of firm, start-up costs, and industry competition. SBA compared the characteristics of the Arrangement of Transportation of Freight and Cargo industry to the average characteristics of all industries with a $5.0 million size standard which is the most common size standard established for nonmanufacturing industries and is referred to as the “anchor” size standard for the nonmanufacturing industries. Doing so enabled SBA to determine if the size standard for Arrangement of Transportation of Freight and Cargo industry should be higher, lower or the same as the $5 million anchor size standard. In addition, SBA reviewed the percent of total Federal contract dollars awarded to small businesses to determine if they were obtaining a reasonable share of Federal contracts. For a further discussion of SBA's size standards methodology and the analyses leading to the proposed size standard see the proposed rule of July 26, 1999 (64 FR 40314).

We also evaluated whether certain funds should be excluded in the calculation of a firm's average annual receipts. We examined five industry characteristics under which it might be appropriate to exclude from a firm's receipts funds received for and then later transmitted to an unaffiliated third party. These five characteristics are: (1) A broker or agent-like relationship exists between a firm and a third party provider and this relationship represents a dominant or crucial activity of firms in the industry; (2) the pass-through funds associated with the broker or agent-like relationship are a significant portion of the firm's total receipts; (3) consistent with the normal business practice of firms in the industry, a firm's income remaining after the pass-through funds are remitted to a third party is typically derived from a standard commission or fee; (4) the firm does not usually consider billings that are reimbursed to other firms as its own income, preferring instead to count only receipts that are retained for its own use; and, (5) Federal government agencies which engage in the collection of statistics and other industry analysts typically represent receipts of the industry firms on an adjusted receipts basis. SBA's review of information found that these characteristics generally exist for the bulk of firms in the industry. Since most firms classified in this industry are Freight Forwarders and Customs Brokers who work on commission, those characteristics supported the proposal to exclude from the calculation of a firm's receipts funds received in trust for unaffiliated third parties.

The comments we received revealed that among the 19 activities listed in SIC 4731, there are two major types of firms in the industry—those that operate as agents/brokers and have funds held in trust for others, and those that do not. For those that operate as agents/brokers the two changes proposed in the rule work together and result in an effective increase in their size standard. For those that do not, the size standard is effectively reduced because they do not benefit from the pass-through provision. To address the different situations between the two groups, we are retaining the current size standard for some of the 19 activities, while adopting the proposed size standard for most other types of firms in SIC 4731. The final rule makes explicit how the remaining non-agent/broker firms included in SIC 4731 are affected by this change in the size standard. We clarify which activities in SIC 4731 will have a size standard of $5.0 million, which activities will benefit from the exclusion of pass-through of funds held in trust in calculating average annual receipts, and which activities continue to use the $18.5 million on gross receipts.

This final rule adopts a size standard of $5.0 million in average annual receipts (after excluding funds received in trust for unaffiliated third parties) for all firms in SIC 4731, except for Household Goods Forwarders and Non-Vessel Owning Common Carriers. Firms engaged in agent/broker activities, such as Freight Forwarder and Customs Broker, receive a significant amount of receipts as pass-through funds which will not be counted in calculating their size. Activities listed in SIC 4731 in which firms do not operate as agents/brokers, such as Freight Consolidation, Freight Rate Auditors, and Tariff Consultants, will also have a size standard of $5.0 million in average annual receipts. However, the calculation of their average annual receipts will be the same as before since they do not receive pass-through funds. Although these firms will not benefit directly from the pass-through exclusion, SBA's analysis of the characteristics of firms in SIC 4731 strongly support the $5 million size standard for this industry. We received no comments from any of these firms in SIC 4731 indicating otherwise.

Included in SIC 4731 but not listed among the 19 activities, is one activity which does not operate either as auditor/consultant or as broker/agent. It is the Non-Vessel Owning Common Carriers. They acquire bulk space on vessels they do not own and sell that space in smaller units to shippers. They do not operate on an agency basis or hold funds in trust for unaffiliated third parties. They therefore must calculate average annual receipts based on gross receipts. These firms have substantial expenses not usually incurred by either the “arranging” or “auditing” types of firms. The $5.0 million size standard would not be reflective of their size operation, therefore we have decided to retain the size standard of $18.5 million for Non-Vessel Owning Common Carriers.

A group of firms not included as part of SIC 4731, but who sometimes use that SIC code for Federal contracting purposes, is Household Goods Forwarders. These firms also incur substantial investment and overhead (such as owning or leasing large trucks and employing drivers) not usually found in the “arranging” or “auditing” firms. They do not operate on commission as agents and do not hold funds in trust for unaffiliated third parties that can be “passed-through” when calculating average annual receipts. To change their size standard from $18.5 million to $5.0 million without benefit of the pass-through provision would have an unintentional adverse impact. Therefore, we are also retaining the $18.5 million size standard for Household Goods Forwarders. This is the same size standard for movers in the transportation industries in Major Group 42.

SBA received 12 timely comments on the proposed SIC 4731 size standards. Two comments are from associations and 10 are from businesses. Nine of the 12 comments opposed the proposed size standard. The objections are from Household Goods Forwarders and Non-Vessel Owning Common Carriers who do not receive any funds that would qualify for the pass-through provision and so would see their size standard reduced. The three comments in support of the proposed size standard are from the Freight Forwarders and Customs Brokers who operate on commissions and fees and who comprise the majority of the firms in SIC 4731. The benefit to this group by allowing average annual receipts to be calculated after excluding pass-through funds effectively increases their size standard by about three times even though the nominal size standard is decreased.

One firm, that operates as a freight forwarder on a commission basis, was strongly in favor of the proposed changes. The commenter discussed the substantial benefit the proposed change in size standard would have for his firm and the approximately 500 other similar firms in his area.

A Freight Forwarder and Customs Broker association, representing over 1,000 members, discussed the diversity of its membership. It noted that “SIC 4731 is not a homogenous classification”. It explained that there are two subsets of activities that operate within the Arrangement of Transportation of Freight and Cargo industry: Household Goods Forwarders and Non-Vessel Owning Common Carriers. The association expressed support for the speedy adoption of the proposed rule for its members who operate as agents/brokers on commission. It also urged SBA to segregate the industries within SIC 4731 and to establish a different size standard for those industries that operate on contract or profit from leasing and sub-leasing activities. Their alternate recommendation, if SBA was to adopt a “one-size-fits-all” size standard, is to make the size standard $10.0 million, not $5.0 million.

Another association also partially supported the proposed rule changes. It represents a large membership divided between those who operate as Freight Forwarders and Customs Brokers for commissions and fees and those who operate as Household Movers on a contract (and sub-contract) basis. It discussed how the activities of its members are diverse enough that different regulatory agencies are responsible for licensing and oversight. The Household Movers are licensed by the Federal Highway Administration (FHWA) while the Freight Forwarders are licensed by the Federal Maritime Commission (FMC). This association also urged us to adopt two different size standards for the industries within SIC 4731. It recommended that SBA retain “the present $18.5 million standard for FHWA freight forwarders and adopt the $5 million standard with its concomitant reduction in receipts for pass-through funds for companies that are engaged in business as FMC ocean freight forwarders and/or customs brokers.”

One group of comments opposing the proposed rule changes was from firms engaged in household moving and storage. Many of these firms obtain contracts from the Department of Defense on a “Single Rate Factor” for “door-to-door” service and subcontract out parts of the contract. They pay the subcontractor ( e.g., the long-distance hauler) out of the single rate. Since these firms do not operate on commission and hold no pass-through funds, the proposed rule would have significantly reduced their size standard. Some of these firms have the word “forwarder” in their names, but their comments describe their activities as the actual mover or as the general contractor responsible for the entire move. For example, their comments included statements such as: “they have to invest in equipment/trucks; * * * sometimes use third parties in providing door-to-door service, but never on an agent-like relationship;” they are “active in the movement of personal household goods”; “sometimes they provide storage;” “they use the services of port agents, etc., but not as brokers;” they are “primarily a household goods forwarder providing door-to-door moving service for the Department of Defense * * * using the “Single-Rate Factor” on a contract basis;” and “as a small business in the moving industry * * *” Only one of the comments from these firms noted that the five industry characteristics discussed in the proposed rule “clearly defines brokers” and agreed that, “it might be appropriate to exclude certain funds” in those cases.

The other group of firms that objected to the change in the proposed size standard operate as entrepreneurs. They are not agents or brokers and they do not operate off of the “one-rate” fee schedule as do the Household Goods Forwarders. This group, known as Non-Vessel Owning Common Carriers, acquire large (bulk) space on ships they do not own, then “retail” that space in smaller lots to actual shippers. They do not view themselves as transportation firms in Major Group 42 (Transportation) because they neither own the ships nor drive the trucks (as do household movers). Their income is derived through the profit (or loss) from the resale of space they acquire in bulk from ship owners. If the ship sails before they have sold all their space, it is possible for the cost of the space to exceed the income derived from the space. They assume that risk as entrepreneurs. In this respect, they operate like wholesalers. The relevant point for this size standard is that their income (like Household Goods Forwarders) is not derived on a commission or fee basis. If the proposed size standard were adopted, they would be limited to the $5.0 million size standard without the benefit of the pass-through funds exclusion because they do not hold any such funds in trust for unaffiliated third parties. They are not currently listed as one of the 19 activities in SIC 4731. Never-the-less, the Census Bureau advised us that they are included in this SIC.

The comments from Household Goods Forwarders and Non-Vessel Owning Common Carriers express a consistent and serious concern. For businesses between $5.0 million and $18.5 million in size that do not operate as agents or brokers that have substantial overhead such as buying trucks or bulk ship space, and that do not derive any receipts from commissions or fees that would qualify as pass-through funds, the change in the size standard from $18.5 million to $5.0 million would effectively lower the size standard and take away their current eligibility to compete for Federal contracts reserved for small business or obtain SBA financial assistance.

The comments revealed that two types of firms who do not operate on commission would be significantly impacted by the proposed size standard through an unintended lowering of the size standard. The purpose of the proposed rule was to recognize that much of the receipts of Freight Forwarders and Customs Brokers (like real estate agents) are held in trust for others and should not be included in the calculation of their size. SBA accepts the significance of the concerns of the Household Goods Forwarders and the Non-Vessel Owning Common Carriers and is therefore retaining the $18.5 million gross average annual receipts size standard for these types of firms.

SBA believes the Household Goods Forwarders who use SIC 4731 will be a small group. In most cases where firms do more than just “arrange” transportation, and do not operate as agents/brokers, SBA believes that a different SIC code is usually more appropriate. Household goods moving and storage is listed by name in SIC 4213 (Trucking, Except Local), SIC 4214 (Local Trucking with Storage), and SIC 4226 (Special Warehousing and Storage, Not Elsewhere Classified). The size standard for these industries is $18.5 million.

The distinction between firms actually moving freight and cargo and those that only arrange or provide transportation services will be more obvious in the North American Industry Classification System (NAICS) which will be effective October 1, 2000 for size standard purposes (see further discussion below). Household movers will be classified in NAICS code 484210—“Used Household and Office Goods Moving,” not Freight Forwarding. The same $18.5 million size standard now applicable to the Transportation industries was also included in the NAICS final rule (65 FR 30836, dated May 15, 2000).

NAICS code 484210 is comprised of parts of SIC 4212, 4213 and 4214 (See NAICS Manual at 859). The definition states “This industry comprises establishments primarily engaged in providing local or long-distance trucking of used household, used institutional, or used commercial furniture and equipment. Incidental packing and storage activities are often provided by these establishments.”(See NAICS Manual at 471). We are aware that some of the activities in which moving firms engage can be classified as “arranging” transportation of freight or cargo. However, firms that provide multiple services should classify themselves under the SIC or NAICS code for their dominant activity. Firms that provide trucks and staff to actually pack, load trucks, drive trucks, store goods on a temporary basis, but who also subcontract out (“arrange for”) parts of the job they cannot or chose not to handle, are more properly classified under an appropriate code within Major Group 42 in the SIC Manual because acting as agents or brokers is not their dominant activity.

In the proposed rule, SBA asked for comments on whether or not Freight Forwarders and Customs Brokers that work on commission usually work for about 6 percent to 10 percent of the total billing. One association responded to this question. It polled its members and verified that the range of commissions is approximately 6 percent to 10 percent.

We accepted the comments and are retaining the $18.5 million size standard for Household Goods Forwarders and Non-Vessel Owning Common Carriers who classify themselves in SIC 4731. This is also the size standard for the transportation industries in Major Group 42 (Transportation) so that regardless of how a Moving and Storage or Non-Vessel Owning Common Carrier firm is classified, it has the same size standard. We believe this is a better approach than establishing a $10.0 million size standard for all firms in SIC 4731 since it takes into account the differences in the firms currently classified under this size standard.

Furthermore, the Census Bureau data does not support a size standard as high as $10.0 million for the entire industry. The Census data collects revenue information in this industry excluding funds received for unaffiliated third parties. Therefore, the data is collected as if the pass-through provision is in effect. We recognize that not all firms in SIC 4731 have trust funds to exclude. Even so, (except for the Non-Vessel Owning Common Carriers and the Household Goods Forwarders) a size standard of $5.0 million fit the data well when differences in how the broker/agent and auditor/consultant firms (classified in SIC 4731) account for their funds are explicitly recognized. The Census Bureau is already making that accommodation in data collection.

The 19 activities currently listed in SIC 4731 will be divided into two industries under the NAICS, which SBA will adopt on October 1, 2000 for its size standards. SBA published a final rule in the Federal Register May 15, 2000 to adopt the NAICS classification, listing each industry and its corresponding size standard (65 FR 30836). SBA's final rule established guidelines to use in cases where activities included in a SIC code were reclassified in NAICS. Newly created classifications generally retained the same size standards that the activity had under the SIC classification. In cases where an activity was removed from one industry group to be included in another industry group, the proposed rule stipulated that the size standard for that industry group would be that of the predominant activity.

As mentioned above, activities currently listed in SIC 4731 will be put into two different classifications in NAICS. Firms that do not operate as agent/brokers such as Freight Rate Auditors and Tariff Consultants currently listed in SIC 4731 will be classified as NAICS 541614, “Process, Physical Distribution, and Logistics Consulting” which is part of “Management Consulting Services.” Other non-agent/broker activities currently included in SIC 4731 include Freight Rate Information Service, Tariff Rate Information Service, Transport Clearinghouse, Transportation Rate Service, Customs Clearance of Freight, Freight Consolidation, Shipping Documents Preparation, and Freight Agencies Railroad, (not operated by Railroad Companies). Of these, Freight Rate Information Service, Freight Consolidation, and Freight Agencies Railroad, (not operated by Railroad Companies) are reclassified as “Freight Traffic Consulting Services,” “Freight Rate Consulting Services” or “Transportation Management Consulting Services” and are also in NAICS 541614.

Using the NAICS procedures for establishing size standards when industries are reclassified, when Tariff Consultants and Freight Rate Auditors are added to the ‘Logistics’ industry (NAICS code 541614), they will have the same $5.0 million size standard applicable to the entire ‘Logistics’ industry. This size standard is consistent with what was proposed for these activities as part of SIC 4731 and what we are adopting in this final rule. All activities in NAICS 541614 will have the $5.0 million size standard and there is no pass-through of commissions for the non-commission entities.

All other activities currently listed in SIC 4731, including agent/broker activities who “arrange transportation” are classified in NAICS 488510, “Freight Transportation Arrangement.” It will be a more homogenous group of firms in NAICS than in the SIC. It is described in the NAICS manual (page 487) as establishments that are “usually known as freight forwarders, marine shipping agents, or customs brokers, and offer a combination of services * * *.” The SBA will also adopt the $5 million size standard for NAICS 488510 when it establishes NAICS-based size standards. It will also allow pass-through of trust funds when calculating average annual receipts for those firms that hold funds in trust for unaffiliated third parties.

This rule is a “significant” regulatory action under Executive Order 12866 and was reviewed by the Office of Management and Budget. However, it is noteworthy that the total value of Federal procurement and SBA guaranteed loans combined is less than $50 million annually to this $9.1 billion industry (1992 Economic data). It is unlikely that these programs would be significantly affected by this change to the size standard. Although potentially 1,000 firms could gain small business status as a result of this rule, historically only a very small percentage of firms in the industry compete for Federal procurements or obtain guaranteed loans through SBA's financial assistance programs.

For purposes of Executive Order 13132, SBA has determined that this rule does not have federalism implications warranting the preparation of a Federalism Assessment.

For purposes of the Regulatory Flexibility Act, this rule will not have a substantial impact on a significant number of small entities. As mentioned above, although potentially 1,000 additional firms could gain small business status as a result of this rule, historically only a very small percentage of firms in the industry compete for Federal procurements or obtain guaranteed loans through SBA's financial assistance programs.

For the purpose of the Paperwork Reduction Act, 44 U.S.C. Ch. 35, SBA has determined that this rule will not impose new reporting or record-keeping requirements.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD for BHTI-manufactured Model HH-1K, TH-1F, TH-1L, UH-1A, UH-1B, UH-1E, UH-1F, UH-1H, UH-1L, and UH-1P; and Southwest Florida Aviation SW204, SW204HP, SW205, and SW205A-1 helicopters was published in the Federal Register on March 24, 2000 (65 FR 15882). That action proposed to require removing any mast assembly, part number (P/N) 204-011-450-001 or -005, and replacing it with an airworthy mast assembly.

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

One commenter states that the FAA's reference to the affected aircraft as “BHTI-manufactured” implies BHTI responsibility. The commenter states that BHTI never obtained an FAA type certificate for the affected helicopters. Although BHTI originally manufactured the affected helicopters for the U.S. military, they have not produced any helicopters of these types for 20 years. The commenter requests that we refer to the affected aircraft as “FAA type certificated U.S. military surplus UH-1 helicopters.” The FAA agrees that BHTI is neither the type certificate holder nor the production certificate holder. However, the FAA does not concur that the terminology “Bell Helicopter Textron Inc.-manufactured” implies BHTI responsibility. The type certificate holder is responsible for defining corrective actions for the aircraft on their type certificate (see 14 CFR 21.99). The FAA uses the terminology “Bell Helicopter Textron Inc.-manufactured Model * * *” only to identify the original manufacturer of the helicopter. The use of this terminology in no way intends to assign or imply responsibility to BHTI.

The commenter also requests that the FAA type certificate holders or the applicable entities be specifically identified in the applicability section of the AD. The FAA does not agree to this request because the type certificate holders are already specifically identified by name in the paragraph immediately preceding the “applicability” paragraph of the AD.

The commenter also states that the mast pole referred to in the NPRM was retired by the Army years ago. Since the commenter understands that the Army manuals are used by the FAA in certifying the affected helicopters, the commenter questions why the helicopters are not already out of configuration. The configuration change to remove these masts from installation eligibility may or may not have been incorporated in the Army manuals. In order to ensure correction of this unsafe condition, the FAA is requiring the design change by issuance of this AD.

The commenter further states that BHTI does not refer to the mast pole as a “thin-walled mast,” but as the “standard wall mast,” and requests that the nomenclature be changed to identify a specific dash numbered mast. The FAA uses the terminology “thin-wall masts” because that wording was used by the U.S. Army in Safety of Flight Message UH-1-84-08 dated July 1984. The terminology is being retained in the summary of this AD for consistency. Specific dash numbers in this AD are used for identifying the affected mast assemblies to be removed. For replacement parts, it is unnecessary to specify the specific dash number; it is only necessary that they be airworthy.

The commenter also states that the term “airworthy mast” is ambiguous. The FAA does not agree. The term “airworthy” is standard aviation terminology and means a part that meets type design and is in a condition for safe operation.

Finally, the commenter states that no mention of the Retirement Index Number (RIN) procedure of counting torque events is mentioned in the NPRM. The commenter states that repeated heavy lifting, such as is involved in logging, greatly reduces the life of the mast as well as other components. The FAA has imposed RIN counting requirements for any replacement masts in Emergency AD 2000-08-53, issued April 26, 2000. RIN counting procedures for the masts, P/N 204-011-450-001 and -005, were mandated by that Emergency AD.

After careful review of the available data, including the comments noted above, the FAA has determined that air safety and the public interest require the adoption of the rule as proposed.

The FAA estimates that 75 helicopters of U.S. registry will be affected by this AD, that it will take approximately 10 work hours per helicopter to accomplish the required actions, and that the average labor rate is $60 per work hour. Replacing a mast assembly will cost approximately $8,862. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $709,650 to replace all the masts in the fleet.

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), which is the airworthiness authority for France, notified the FAA that an unsafe condition may exist on Eurocopter France Model SA-365N, N1, and AS-365N2, N3 helicopters with CENTRISEP EAPS sand filters installed. The DGAC advises that a crack on a nozzle can result in separation of the nozzle from the helicopter. The DGAC has issued AD No. 2000-108-050(A), dated March 22, 2000, in order to assure 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 § 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement. Pursuant to this bilateral airworthiness agreement, the DGAC has kept the FAA informed of the situation described above. The FAA has examined the findings of the DGAC, reviewed all available information, and determined that AD action is necessary for products of this type design that are certificated for operation in the United States.

Since an unsafe condition has been identified that is likely to exist or develop on other Eurocopter France Model SA-365N, N1, and AS-365N2, N3 helicopters of the same type design registered in the United States, this AD is being issued to prevent loss of a nozzle in flight, impact with the main or tail rotor, and a subsequent forced landing. This AD requires inspecting each nozzle for a crack before further flight, and thereafter before the first flight of each day. Replacing any cracked nozzle with an airworthy nozzle is also required before further flight.

No helicopters on the U.S. registry will be affected by this AD since the sand filter kit (kit) that contains the nozzles is not currently installed on any helicopter in the U.S. fleet. Should a kit be installed on a helicopter listed on the U.S. Registry, it would take approximately 1.0 work hour per helicopter to inspect the nozzles and 2 work hours to replace a nozzle, if necessary. The average labor rate is $60 per work hour. Based on these figures, and assuming that the kit is installed on a helicopter, the total cost impact of this AD on a U.S. operator is estimated to be $60 for each day of flight operations assuming a nozzle does not need to be replaced.

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 the Federal 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 caption ADDRESSES. All communications received on or before the closing date for comments will be considered, and this rule may be amended in light of the comments received. Factual information that supports the commenter's ideas and suggestions is extremely helpful in evaluating the effectiveness of the AD action and determining whether additional rulemaking action would be needed.

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

Commenters wishing the FAA to acknowledge receipt of their 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. 2000-SW-09-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 registered in the United States have the affected sand filter kit installed. 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 caption ADDRESSES.

On July 14, 2000, the FAA published in the Federal Register a direct final rule; request for comments which revises the Class E airspace at Atwood, KS (FR document 00-17870, 65 FR 43684, Airspace Docket No. 00-ACE-19). An error was subsequently discovered in the latitude of the Atwood NDB and the bearing in the airspace designation for Atwood-Rawlins County, City-County Airport. This action corrects those errors. After careful review of all available information related to the subject presented above, the FAA has determined that air safety and the public interest require adoption of the rule. The FAA has determined that this correction will not change the meaning of the action nor add any additional burden on the public beyond that already published. This action corrects the error in the Atwood NDB latitude and the airspace designation.

The FAA uses the direct final rulemaking procedure for a non-controversial rule where the FAA believes that there will be no adverse public comment. The direct final rule; request for comments advised the public that no adverse comments were anticipated, and that unless a written adverse comment, or a written notice of intent to submit such an adverse comment, were received within the comment period, the regulation would become effective on November 30, 2000.

On May 18, 2000, the FAA proposed to amend 14 CFR part 71 to delete a segment of V-162 that is unusable for navigation (65 FR 31504). Flight inspection found that the radial between the Harrisburg VORTAC and Hyper Intersection is not usable due to signal roughness and scalloping. This problem renders the affected segment unusable for navigation purposes. The FAA has issued a Flight Data Center Notice to Airmen advising users of this restriction.

Interested parties were invited to participate in this rulemaking proceeding by submitting comments. No comments were received. Except for editorial changes, this rule is the same as that proposed in the notice.

This action amends part 71 by deleting the portion of VOR Federal Airway V-162 between the Martinsburg, WV, VORTAC and the Harrisburg, PA, VORTAC. Flight inspection has found that the radial extending from the Harrisburg VORTAC to the Hyper Intersection is not usable for navigation due to signal roughness and scalloping. As a result of this problem, the portion of the airway between Martinsburg VORTAC and Harrisburg VORTAC is being deleted. Other existing published airways provide alternative routing between the Martinsburg VORTAC and Harrisburg VORTAC.

Domestic VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.9G, dated September 1, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The airway listed in this document will be published subsequently in the Order.

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 12866; (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, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

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

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

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

Section 216 of FDAMA replaced the “four of a kind” rule in the old section 520(h)(4) of the act (21 U.S.C. 360j(h)(4)) with a provision that frees safety and effectiveness data in PMA's approved 6 or more years earlier for use by the agency in certain actions, including device reclassifications. Under section 520(h)(4) of the act, as amended by FDAMA, the agency has supplemented other sources of information that support reclassification of the extracorporeal shock wave lithotripter with data contained in PMA's approved 6 or more years before the date of this rule. Although FDA has sufficient information to support this reclassification without relying upon data available under section 520(h)(4) of the act, the agency decided to use such data in taking this action. In this instance, the data used would have been available to the agency under the superseded four of a kind rule.

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

FDA referred the issue of reclassification of the extracorporeal shock wave lithotripter to the Gastroenterology and Urology Devices Advisory Panel (the Panel) for review and recommendation. At a public meeting on July 30, 1998, the Panel unanimously recommended that the extracorporeal shock wave lithotripter indicated for the fragmentation of kidney and ureteral calculi be reclassified from class III to class II. The Panel believed that the special controls of consensus standards, clinical performance testing, labeling restrictions, and physician training restrictions would provide reasonable assurance of the safety and effectiveness of the device. In the Federal Register of February 8, 1999 (64 FR 5987), FDA published a summary of the Panel recommendation and a proposed rule to reclassify the extracorporeal shock wave lithotripter. FDA invited interested persons to submit written comments by May 10, 1999. FDA received one comment that raised several issues. The following is FDA's response to the issues raised by the comment.

(Comment 1) The comment suggested that FDA should identify the PMA's and PMA supplements that FDA relied upon in reclassifying the device and make the summaries of safety and effectiveness for those submissions available in the Dockets Management Branch.

FDA agrees. The PMA's that FDA relied upon are listed in section VII “References” below and the summaries of safety and effectiveness are available in the Dockets Management Branch, as stated there. Section 520(h)(4)(b) of the act states that the summaries of safety and effectiveness shall be available for use by FDA as the evidentiary basis for a reclassification action. FDA notes, however, that section 520(h)(2) of the act provides that the summaries of safety and effectiveness may not be used to establish the safety or effectiveness of another device by any person other than the person who submitted the information. In the case of certain supplements for which a summary of safety and effectiveness was not prepared, FDA will make available a redacted version of the supplement.

(Comment 2) The comment questions whether FDA believes that section 520(h)(4) of the act allows for the use of information from PMA supplements as well as original PMA's.

Yes. Section 520(h)(4) of the act authorizes FDA to use data contained in applications for premarket approval submitted under section 515(c) of the act. The 6-year provision, then, applies equally to initial PMA submissions and PMA supplements, which are applications for premarket approval of a changed device and are submitted under section 515(c) of the act, the general PMA authority.

(Comment 3) The comment also said that persons submitting a premarket notification (510(k)) other than holders of approved PMA's and PMA supplements should only be able to use as predicate devices model numbers or modified versions of extracorporeal shock wave lithotripters legally marketed under a 510(k), PMA, or PMA supplement no sooner than 6 years before the applicant's 510(k) submission for a new or modified device. Holders of an approved PMA or PMA supplement should be the only applicants permitted to cite as a predicate the device for which they have an approved application fewer than 6 years old.

FDA disagrees with this comment. Section 513(i) of the act provides that substantial equivalence may be determined based upon comparison with any legally marketed device. The intent of section 520(h)(4) of the act is to provide an additional source of information upon which certain actions can be based. Section 520(h)(4) of the act does not place any limitations on the type of device that may be used as a predicate device.

(Comment 4) The comment said that the indications for use in the proposed rule are inconsistent with those in the approved PMA's and PMA supplements to date. The comment also said that the labeling restrictions in the rule do not address indications for use and questioned how manufacturers may switch to the broad intended use in the rule.

FDA disagrees. The intended use in the rule (i.e., “fragmentation of urinary calculi within the kidney and ureter”) is consistent with prior approvals. Although some devices were restricted in their intended use to certain stone locations or size ranges based on the results or circumstances of their specific clinical studies, others had adequate data supporting the more general intended use. Therefore, the broad intended use in the rule incorporates both of the individual intended uses that have been approved to date. This approach was based on findings in the literature that the differences in intended use of approved lithotripters were not primarily related to differences in technological characteristics. Because FDA is reclassifying a broad intended use, FDA believes that it is appropriate to list the various stone characteristics known to be associated with reduced effectiveness as precautions in the labeling. Manufacturers who have cleared devices with the limited intended uses can seek clearance to market their devices for the broad intended use by submitting a 510(k) comparing the device to a predicate that has the broad intended use.

(Comment 5) The comment noted that the guidance suggests that a confirmatory clinical study should enroll at least 20 patients at 2 sites. The comment questioned whether this means 20 patients at each site or 20 patients total at both sites. The comment further said that, in either case, the number is insufficient. The comment suggested that FDA should require 30 patients each at 3 sites and the study should include an assessment of treatment success and adverse effects immediately post-procedure and at 2 weeks and 1 month thereafter.

The guidance has been revised to clarify that clinical testing of devices that are similar in technological characteristics to legally marketed devices should include at least 20 patients total at 2 sites. FDA disagrees with the comment that there is a need to assess device safety and effectiveness outcomes in a statistically justified sample size. FDA believes that clinical testing in these circumstances is intended only to confirm device functionality and the adequacy of the proposed labeling rather than to assess device safety and effectiveness. FDA believes that the characterization testing described in the guidance is sufficient to demonstrate safety and effectiveness with respect to clinical outcomes for devices with similar technological characteristics. As noted in the proposed rule and guidance document, however, 510(k)'s for devices that have different technological characteristics from legally marketed predicates will likely require larger, statistically justified, clinical studies to investigate the effect of the new technological characteristics on safety and effectiveness outcomes. For these cases, the study design should be tailored to the specifics of the new characteristics; therefore, we do not believe that a standard detailed study design should be spelled out.

(Comment 6) The comment suggested that the restricted device legend for the device should be revised to read: “CAUTION: Federal law restricts this device to sale, distribution, and use only upon the lawful order of a physician trained and/or experienced in the use of this device as outlined in the required training program.” The comment also suggested that this statement should be included in the regulation and not just in the guidance.

FDA agrees in part with this comment. FDA has added the words “distribution or use” after “sale” so as to track the language in section 520(e) of the act. FDA does not believe that it would not be correct to replace the phrase “appropriate training program” with “required training program” as suggested by the comment, because FDA does not regulate all aspects of the training program. Also, FDA does not believe that it is necessary to add the language to the regulation, because the requirement is already covered by 21 CFR 801.109(b)(1). FDA has decided not to include the labeling in an appendix to § 876.5990 (21 CFR 876.5990). Instead, the labeling will be included in the guidance document only. FDA also slightly revised the identification section in § 876.5990(a) by removing the words “through a water-filled rubber cushion or by direct contact of the patient's skin with the water” and replacing them with “using an appropriate acoustic interface.”

Therefore, FDA is finalizing the rule reclassifying the extracorporeal shock wave lithotripter into class II with the FDA guidance document entitled “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi,” as the special control. Elsewhere in this issue of the Federal Register , FDA is publishing a notice of availability of the guidance document.

The agency has determined under 21 CFR 25.24(b) 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) (as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4)). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages, distributive impacts and equity). The agency believes that this reclassification action is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the reclassification action is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order. The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Reclassification of the device from class III to class II will relieve manufacturers of the cost of complying with the premarket approval requirements in section 515 of the act. Because reclassification will reduce regulatory costs with respect to this device, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace at lower costs. The agency therefore certifies that this reclassification action will not have a significant economic impact on a substantial number of small entities. In addition, this reclassification action will not impose costs of $100 million or more on either the private sector or state, local, and tribal governments in the aggregate, and therefore a summary statement of analysis under section 202(a) of the Unfunded Mandates Reform Act of 1995 is not required.

FDA concludes that this final rule contains no information that is subject to review by the Office of Management and Budget under the Paperwork Reduction Act of 1995. The special controls do not require the respondent to submit additional information to the public. Therefore, no burden is placed on the public.

The following references have been placed on display in the Dockets Management Branch, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday.

The City of Baltimore will sponsor the Defender's Day fireworks display on September 9, 2000 on the Patapsco River, Baltimore, Maryland. The fireworks display will be launched from a barge positioned within the regulated area. In order to ensure the safety of spectators and transiting vessels, 33 CFR 100.515 will be in effect for the duration of the event. Under provisions of 33 CFR 100.515, a vessel may not enter the regulated area unless it receives permission from the Coast Guard Patrol Commander. Spectator vessels may anchor outside the regulated area but may not block a navigable channel. Because these restrictions will be in effect for a limited period, they should not result in a significant disruption of maritime traffic.

Although this rule is being published as a temporary final rule without prior notice, an opportunity for public comment is nevertheless desirable to ensure the rule is both reasonable and workable. Accordingly, we encourage you to submit comments and related material. If you do so, please include your name and address, identify the docket number (CGD05-00-028), indicate the specific section of this document to which each comment applies, and give the reason for each comment. Please submit all comments and related materials in an unbound format, no larger than 8.5 by 11 inches, suitable for copying. If you would like to know they reached us, please enclose a stamped, self-addressed postcard or envelope.

A notice of proposed rulemaking (NPRM) was not published for this regulation. In keeping with 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. The Coast Guard received confirmation of the request for special local regulations on June 14, 2000. We were notified of the event with insufficient time to publish a NPRM, allow for comments, and publish a final rule prior to the event.

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 the Federal Register . We had insufficient time to prepare and publish this rule in the Federal Register 30 days in advance on the event. To delay the effective date of the rule would be contrary to the public interest since a timely rule is necessary to protect mariners from the hazards associated with the event.

On August 12 and August 13, 2000, the Harford County Power Boat Club will sponsor the Harford County Power Boat Regatta on the waters of the Bush River, near Abingdon, Maryland. The event will consist of 60 hydroplanes and runabouts racing in heats counter-clockwise around an oval race course. A fleet of spectator vessels is anticipated. Due to the need for vessel control during the races, vessel traffic will be temporarily restricted to provide for the safety of spectators, participants and transiting vessels.

The Coast Guard is establishing temporary special local regulations on specified waters of the Bush River. The temporary special local regulations will be in effect from 11:30 a.m. to 6:30 p.m. on August 12 and August 13, 2000, and will restrict general navigation in the regulated area during the event. Except for participants and vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area without first obtaining permission from the official patrol. Non-participating vessels will be allowed to transit the event area at minimum wake speed, at the Patrol Commander's discretion. These regulations are needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 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).

We expect the economic impact of this temporary final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary.

Although this regulation prevents traffic from transiting a portion of the Bush River during the event, the effect of this regulation will not be significant due to the limited duration of the regulation, the fact that the Coast Guard Patrol Commander will allow non-participating vessels to transit at minimum wake speed whenever it is safe to do so, and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises 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.

This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in the effected portions of the Bush River during the event.

Although this regulation prevents traffic from transiting or anchoring in a portion of the Bush River during the event, the effect of this regulation will not be significant because of its limited duration, the fact that the Coast Guard Patrol Commander will allow non- participating vessels to transit at minimum wake speed whenever it is safe to do so, and the extensive advance notifications that will be made to the maritime community via the Local Notice to Mariners, marine information broadcasts, and area newspapers, so mariners can adjust their plans accordingly.

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

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those costs. This rule will not impose an unfunded mandate.

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.

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 concern an environmental risk to health or risk to safety that may disproportionately affect children.

We prepared an “Environmental Assessment” in accordance with Commandant Instruction M16475.1C, and determined that this rule will not significantly affect the quality of the human environment. The “Environmental Assessment” and “Finding of No Significant Impact” is available in the docket where indicated under ADDRESSES .

We did not publish a Notice of Proposed Rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. It was impracticable to attempt to publish a NPRM for this situation due to the uncertainty surrounding the scheduling of the first LNG ship into the EcoElectrica facility.

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 the Federal Register because of the imminent arrival of the first LNG ship into the EcoElectrica facility. Publishing an NPRM and delaying its effective date would be contrary to public safety since immediate action is needed to minimize potential danger to the public upon arrival of the LNG carrier.

These regulations are needed to provide for the safety of life on navigable waters from hazards associated with LNG carriers. The safety zones are established because of the significant risks LNG ships present with their highly volatile cargoes, their size, and draft. A safety zone will be established in a 100 yard radius surrounding an LNG carrier with product aboard while transiting north of Latitude 17°56.0′N in the waters of the Caribbean Sea and Guayanilla Bay, Puerto Rico. This Safety Zone remains in effect until the LNG vessel is alongside the Eco-Electrica waterfront facility in Guayanilla Bay. A Safety Zone will also be established in the waters within 150 feet of an LNG vessel when the vessel is alongside the Eco-Electrica waterfront facility. This Safety Zone remains in effect while the LNG vessel remains at the dock with product aboard or is transferring liquefied natural gas.

We anticipate periodic arrivals of LNG carriers in Guayanilla Bay. Therefore, in conjunction with this temporary rule necessary for immediate arrivals, we will undertake a permanent rulemaking with opportunity for notice and comment.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 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). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10(e) of the regulatory policies and procedures of DOT is unnecessary due to the relatively infrequent arrivals of LNG carriers and the sparse nature of commercial traffic in Guayanilla Bay.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic effect upon a substantial number of small entities. The term “small entities” comprises 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. The rule may affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit a portion of Guayanilla Bay during the entry of an LNG vessel into the bay and its subsequent docking and transfer operations at the Eco-Electrica facility. This regulation will not have a significant economic impact on a substantial number of small entities because of the infrequent LNG vessel arrivals into Guayanilla Bay and the short transit time into the bay. Vessel traffic will not be impeded while the LNG carrier is moored to the dock at the Eco-Electrica facility.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub.L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If the rule would affect your small business, organization, or government jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed under FOR FURTHER INFORMATION CONTACT for assistance in understanding and participating in this rulemaking. We also have a point of contact for commenting on actions by employees of the Coast Guard. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

This rule calls for no new collection of information requirements under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ).

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not have implications for federalism under that order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government's having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

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.

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 concern an environmental risk to health or safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of this action and has determined under figure 2-1, paragraph 34(g) of Commandant Instruction M16475.1C, that this rule is categorically excluded from further environmental documentation because it is establishing a temporary Safety Zone.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(8) and (d)(3), the Coast Guard finds that good cause exists for not publishing a NPRM and making this rule effective less than 30 days after publication in the Federal Register . The sponsor of the event did not provide the Coast Guard with the final details for the event in sufficient time to publish a NPRM or a final rule 30 days in advance. The delay encountered if normal rulemaking procedures were followed would effectively cancel the event. Cancellation of this event is contrary to the public interest since the fireworks display is for the benefit of the public.

The Old Saybrook Chamber of Commerce, of Old Saybrook, CT is sponsoring a fireworks display after the Saybrook Summer Pops concert. The fireworks will be launched from Saybrook Point on the Connecticut River, Old Saybrook, CT. The fireworks display will occur on August 13, 2000, following the concert. The safety zone covers all waters of the Connecticut River within a 400 foot radius of the fireworks launching area which will be located north of the dock on Saybrook Point, Connecticut River, CT in approximate position: 41°-17′35″N, 072°-21′20″W, (NAD 1983). This zone is required to protect the maritime community from the safety dangers associated with this fireworks display. Entry into or movement within this zone will be prohibited unless authorized by the Captain of the Port or his on-scene representative.

This rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866 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). The Coast Guard expects the economic impact of this proposal to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This safety zone involves only a portion of the Connecticut River and entry into this zone will be restricted for only 120 minutes on August 13, 2000. Although this regulation prevents traffic from transiting this section of the Connecticut River, the effect of this regulation will not be significant for several reasons: the duration of the event is limited; the event is at a late hour; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses not-for-profit organizations that are independently owned and operated 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 impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit or anchor in a portion of the Connecticut River from 8:30 p.m. until 10:30 p.m. on August 13, 2000. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: The duration of the event is limited; the event is at a late hour; all vessel traffic may safely pass around this safety zone; and extensive, advance maritime advisories will be made.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard wants to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If your small business or organization would be affected by this rule and you have any questions concerning its provisions or options for compliance, please call Chief Chris Stubblefield at (203) 468-4428. Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247).

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

We have analyzed this rule under Executive Order 13132 and have determined that this rule does not implications for federalism under that Order.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or tribal government or the private sector to incur direct costs without the Federal Government having first provided the funds to pay those unfunded mandate costs. This rule will not impose an unfunded mandate.

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

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

We have analyzed this proposed 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 concern an environmental risk to health or risk to safety that may disproportionately affect children.

The Coast Guard has considered the environmental impact of this rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction, M 16475.C, this rule is categorically excluded from further environmental documentation. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under Addresses.

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 under FOR 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 the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301024. 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.

EPA issued a final rule, published in the Federal Register of January 20, 1999 (64 FR 3003) (FRL-6047-3), which announced that on its own initiative under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-limited tolerances for residues of fenpropathrin in or on soybean forage at 15.0 ppm, soybean hay at 20.0 ppm, soybean hulls at 1.0 ppm, soybean meal at 0.2 ppm, soybean refined oil at 1.5 ppm, and soybean seed at 0.1 ppm, with an expiration date of June 30, 2000. EPA established these tolerances because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. In the Federal Register of September 9, 1998 (63 FR 48113) (FRL-6020-2), EPA issued a Final Rule extending a time-limited tolerance for residues of fenpropathrin in or on currants at 15.0 ppm, with an expiration date of June 30, 2000.

EPA received a request to extend the use of fenpropathrin on soybeans for this year's growing season; the Applicant stated that the two-spotted spider mite is a serious pest of soybeans in Delaware and Maryland.

Delaware: During the 1997 field season in Delaware, fields were sprayed 3-5 times with dimethoate, Lorsban and Parathion. While dimethoate provided systemic activity, it has been ineffective in recent years due to reduced systemic activity when fields are drought stressed resulting in poor absorption and translocation of the chemical into the leaf tissue. The two-spotted spider mite may also be developing resistance to dimethoate. Since July 17, 1998, the mite population in Delaware has begun to explode in soybean fields and dimethoate applications have not provided control.

Maryland: Maryland's emergency situation is very similar to Delaware. Maryland too used dimethoate and Lorsban with control ranging from 0 to less than 30%. Maryland growers have experienced increasing problems with spider mites in soybean fields. In 1997, the mite population reached record high levels on more than 50% of the soybean acreage and caused significant losses in yield and increased production costs. Dimethoate has been the chemical of choice in Maryland because of its systemic and longer residual action. However, numerous control failures with dimethoate have been reported in 1997. Dimethoate has been ineffective in recent years due to reduced systemic activity when fields are drought stressed resulting in poor absorption and translocation of the chemical into the leaf tissue. In the Eastern Shore where the problem is more intense, control failures are also believed to be the result of dimethoate-tolerant populations caused by repeated use of this product over the years. EPA has authorized under FIFRA section 18 the use of fenpropathrin on soybeans for control of two-spotted spider mite ( tetranychus urticae ) in Delaware and Maryland. EPA concurs that emergency conditions exist for these states. After having reviewed the submission, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of fenpropathrin on soybeans for control of pest.

EPA assessed the potential risks presented by residues of fenpropathrin in or on currants, and soybeans. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the Final Rule of July 14, 1997 (62 FR 37516) (FRL-5731-3). Based on that data and information considered, the Agency reaffirms that extension of the time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are extended for an additional 18 month-period. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances have expired and are revoked on June 30, 2000, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on currants, and soybeans after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerances. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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-301024 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 October 10, 2000.

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 III.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-301024, 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 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a time-limited tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

You may be 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 under FOR 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 the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for this action under docket control number OPP-301025. 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 the Federal Register of January 30, 1998 (63 FR 4631) (FRL-5766-2), 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 Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition for tolerance by FMC Corporation, 1735 Market Street, Philadelphia, PA 19103. This notice included a summary of the petition prepared by FMC Corporation, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.515 be amended by establishing a tolerance for residues of the herbicide carfentrazone-ethyl, (ethyl-alpha-2-dichloro-5-[-4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1-yl]-4-fluorobenzenepropanoate), in or on cereal grain at 0.1 ppm; in or on hay at 0.3 ppm; in or on straw at 0.2 ppm; in or on forage at 1.0 ppm; in or on stover at 0.15 ppm; and in or on sweet corn, K + CWHR (kernels plus cob with husk removed) at 0.1 ppm, and in or on the raw agricultural commodities (RACs) soybeans and soybean seed at 0.1 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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 carfentrazone-ethyl and its metabolite carfentrazone-chloropropionic acid in or on grain, cereal, group at 0.1 ppm; grain, cereal, forage (excluding corn and sorghum) at 1.0 ppm; grain, cereal, straw (excluding rice) at 0.1 ppm; grain, cereal, stover at 0.3 ppm; grain, cereal, hay at 0.3 ppm; corn, field, forage at 0.2 ppm; corn, sweet, forage at 0.2 ppm; sorghum, forage at 0.2 ppm; rice, straw at 1.0 ppm; corn, sweet, kernel plus cob with husk removed at 0.1 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances 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 carfentrazone-ethyl are discussed in this unit.

1. A battery of acute toxicity studies places the technical-grade herbicide in Toxicity Categories III and IV. No evidence of sensitization was observed following dermal application in guinea pigs.

2. A 90-day subchronic feeding study was conducted in rats at intake levels of 0, 58, 226, 470, 831 and 1,197 milligrams/kilograms/day (mg/kg/day) for males and 0, 72, 284, 578, 1,008 and 1,427 mg/kg/day in females, respectively. The no observed adverse effect level (NOAEL) was 226 mg/kg/day in males and 284 mg/kg/day in females. The lowest observed adverse effect level (LOAEL) was 470 mg/kg/day in males and 578 mg/kg/day in females based on decreases in body weight, reductions in food consumption and histopathological lesions.

3. A 90-day subchronic feeding study was conducted in mice at dietary intake doses of 0, 143, 571, 1,143, 2,000, and 1,857 mg/kg/day. The LOAEL was 1,143 mg/kg/day based on findings in the liver pathology. The NOAEL was 571 mg/kg/day.

4. A 90-day subchronic feeding study in dogs administered by dietary intake doses of 0, 50, 150, 500 and 1,000 mg/kg/day. The NOAEL was 50 mg/kg/day and the LOAEL was 150 mg/kg/day based on systemic toxicity (decrease in the rate of weight gain in females and an increase in porphyrin levels in both sexes).

5. An 18-month mouse carcinogenicity study was conducted in mice at dietary intake doses of 0, 10, 110, and 1,090 mg/kg/day for males and 0, 12, 119, and 1,296 mg/kg/day for females. The study found the compound to be noncarcinogenic to mice under the conditions of the study. The systemic NOAEL was 70 ppm (equivalent to 10 mg/kg/day for males and 12 mg/kg/day for females), and the systemic LOAEL was 700 ppm (equivalent to 110 mg/kg/day for males and 119 mg/kg/day for females) based on increased mortality and microscopic signs of hepatotoxicity.

6. A 2-year rat chronic toxicity/carcinogenicity study was conducted in rats at intake levels of 0, 2, 9, 37, and 188 mg/kg/day for males and 0, 3, 12, 49, and 242 mg/kg/day for females. The study found the compound to be noncarcinogenic to rats under the conditions of the study. The NOAEL was 200 ppm (9 mg/kg/day ) for males and 50 ppm (3 mg/kg/day) for females. The LOAEL was 800 ppm (37 mg/kg/day) for males and 200 ppm (12 mg/kg/day) for females, based on liver histopathology and total urinary porphyrin.

7. A 1-year feeding study in dogs dosed at levels of 0, 50, 150, 500, and 1,000 mg/kg/day in both sexes with a NOAEL of 50 mg/kg/day and a LOAEL of 150 mg/kg/day, based on an increase mean total urinary porphyrins.

8. A developmental toxicity study in rats was conducted in rats at dose levels of 0, 100, 600, and 1,250 mg/kg/day in females, with a maternal LOAEL of 600 mg/kg/day based on staining of the abdominogenital area and a maternal NOAEL of 100 mg/kg/day; a developmental LOAEL of 1,250 mg/kg/day based upon a significant increase in the litter incidences of wavy and thickened ribs; and a developmental NOAEL of 600 mg/kg/day.

9. A developmental toxicity study in rabbits was conducted at gavage dose levels of 0, 10, 40, 150, and 300 mg/kg/day. Evidence of treatment-related maternal toxicity consisted of unthriftiness and emaciation in two does at 300 mg/kg/day. There were no treatment-related mortalities or gross pathological findings. No effects on body weight, body weight change, or organ weight data were identified at any treatment level. However, when considered in conjunction with the findings of the two pilot dose-setting studies, which were conducted at higher dose levels and which identified a steep dose-response curve with maternal mortality occurring at doses of 350 mg/kg/day and above, it was determined that 300 mg/kg/day provided an adequate high-dose assessment of maternal toxicity in rabbits. The maternal toxicity NOAEL is greater than/equal to 150 mg/kg/day and maternal LOAEL of 300 mg/kg/day. There was no evidence of treatment-related prenatal development toxicity, the developmental LOAEL was not determined and the developmental NOAEL is greater than/equal to 300 mg/kg/day.

10. A 2-generation reproduction study in the rat at dietary levels of 0, 8.6, 42.4, 127, 343 mg/kg/day for males, and 0, 9.5, 47.8, 142, and 387 mg/kg/day for females established a parental NOAEL for systemic and reproductive/developmental parameters of 127 mg/kg/day for males and 142 mg/kg/day for female. The parental LOAEL for systemic and reproductive development parameters was 343 mg/kg/day for males and 387 mg/kg/day for females. There was no systemic toxicity demonstrated at dose levels of less than/equal to 1,500 ppm. There were no treatment-related clinical signs of toxicity or increases in mortality at any dose levels. The offspring NOAEL was 142 mg/kg/day and the LOAEL was 387 mg/kg/day. The NOAEL for reproductive toxicity was greater than/equal to 387 mg/kg/day; the highest dose tested. There were no clinical signs of toxicity reported for the pups of either generation.

11. In an acute neurotoxicity study in rats at gavage doses of 0, 500, 1,000, and 2,000 mg/kg, a NOAEL of 500 mg/kg and a LOAEL of 1,000 mg/kg were based upon clinical observations (i.e., salivation) and motor activity. There was no evidence of neuropathology.

12. A 90-day subchronic neurotoxicity study in the rat was conducted at dietary levels of 0, 59, 603, and 1,178 mg/kg/day for males and 0, 71, 718, and 1,434 mg/kg/day for females, with a NOAEL of 59 mg/kg/day for males and 71 mg/kg/day for females. The LOAEL was 603 mg/kg/day for males and 718 mg/kg/day for females based on decreased body weight.

13. Two reverse gene mutation assays ( salmonella typhimurium ) at dose yielded negative results, both with and without metabolic activation.

14. An in vitro mammalian cell forward gene mutation assay in CHO cells yielded negative results both with and without activation.

15. An in vitro chromosomal abberation assay yielded positive results under nonactivated conditions following doses of 3.75, 12.5, 37.5, and 125 micrograms/milliliter (mu;g/mL). There were consistent and statistically significant increased incidences of cells with aberrations at 125 mu;g/mL, the highest dose tested in the absence of metabolic activation.

16. An in vivo mouse micronucleus cytogenic assay test was negative for clastogenic and/or aneugenic activity, following intraperitoneal injection doses of 600, 1,200, and 2,400 mg/kg. Dosed animals showed no reduction in the ratio of polychromatic erythrocytes to total erythrocytes. There was no evidence of polychromatic erythrocytes associated with exposure to the test material.

17. An unscheduled in vivo/in vitro DNA synthesis assay was negative following a single IP injection doses of 750, 1,500, 3,000 mg/kg. Slight lethargy was seen in the high dose animals. Higher levels (4,000 mg/kg/) were lethal in a preliminary study. Cytotoxicity for the hepatocytes was not apparent at any dose. The results obtained with the positive controls confirmed the sensitivity of the test system to detect unscheduled DNA synthesis (UDS). There was, however, no evidence that the test material induced agenotoxic response at any dose or sacrifice time.

18. A metabolism study in rats indicated that approximately 72.4 to 87% of the administered dose of carfentrazone-ethyl was rapidly absorbed and excreted in the urine within 24 hours after dosing. The major metabolites in both the urine and feces were F8426-chloropropionic acid (48.4 to 66.06%). The proposed metabolic pathway appeared to be the conversion of the parent compound by hydrolysis of the ester moiety to form F8426-chloropropionic acid, followed by oxidative hydroxylation of the methyl group to form 3-hydroxymethyl-F8426-chloropropionic acid, or dehydrochlorination to form F8426-cinnamic acid.

1. Acute toxicity. The acute population adjusted dose (aPAD) is based on the acute neurotoxicity study in rats. The NOAEL of 500 mg/kg/day, was based on clinical observations (i.e., salivation) and decreased motor activity at the LOAEL of 1,000 mg/kg/day. The aPAD of 5 mg/kg/day is based on interspecies extrapolation (10x), intraspecies variability (10x), and the FQPA 1x factor.

2. Short- and intermediate-term toxicity. No systemic toxicity was seen at the limit-dose 1,000 mg/kg/day in a 21-day dermal toxicity study in rats.

3. Chronic toxicity. The chronic PAD (cPAD) is based on a 2-year chronic toxicity study in rats. The NOAEL of 3 mg/kg/day was based on liver histopathology (increases in microscopic red fluorescence of the liver, liver pigment) and total mean urinary porphyrin observed at the LOAEL of 12 mg/kg/day. The cPAD of 0.03 mg/kg/day is based on interspecies extrapolation (10x), intraspecies variability (10x), and the FQPA 1x factor.

4. Carcinogenicity. EPA classified carfentrazone-ethyl as a “not likely” human carcinogen according to EPA's Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996).

1. From food and feed. Tolerances have been established (40 CFR 180.515) for the combined residues of carfentrazone-ethyl and its chloropropionic acid, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures in food from carfentrazone-ethyl as follows:

i. Acute exposure and risk. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The acute dietary risk assessment was conducted using the Dietary Exposure Evaluation Model (DEEM TM ver. 7.075) and consumption data from the U.S. Department of Agriculture (USDA) 1989-92 Nationwide Continuing Surveys of Food Intake by Individuals (CSF II). The acute analysis assumed tolerance level residues and 100% crop treated for all registered and proposed uses. The acute dietary food exposure estimates to carfentrazone-ethyl were less than the Agency's level of concern (less than 100% aPAD) for the general U.S. population and all population subgroups.

ii. Chronic exposure and risk. A chronic dietary exposure analysis was conducted using the Dietary Exposure Evaluation Model (DEEM TM ver. 7.075) and consumption data from the USDA 1989-92 Nationwide Continuing Surveys of Food Intake by Individuals (CSF II). The chronic analysis assumed tolerance level residues and 100% crop treated for all registered and proposed uses. The chronic dietary food exposure estimates to carfentrazone-ethyl, for all population subgroups, were less than the Agency's level of concern (less than 100% cPAD).

2. From drinking water. Carfentrazone-ethyl breaks down rapidly in the environment to carfentrazone-chloropropionic acid (F8426-ClPAc). The chloropropionic acid degradate subsequently breaks down to F8426-cinnamic acid, F8426-propionic acid, F8426-benzoic acid, and 3-hyroxymethyl-F8426-benzoic acid at slower rates than the parent compound. Aquatic dissipation and anerobic soil metabolism studies suggest that residues in the subsurface may be longer lived than residues in surface water. Ground and surface water estimated environmental concentrations (EECs) for carfentrazone-ethyl and degradates (F8426-cinnamic acid, F8426-propionic acid, F8426-benzoic acid, and 3-hyroxymethyl F8426-benzoic acid) were generated using screening models GENEEC (surface water) and SCI-GROW (ground water). Both models assumed an application rate of 0.031 lbs ai/acre. The surface water estimates are 1.69 μg/L; peak concentration (0.65 μg/L; 56-day average). The ground water estimate is 6.55 μg/L. Carfentrazone-ethyl may also be applied to flooded rice fields and the treated water subsequently released to surface water. Based on the aquatic dissipation study submitted by the petitioner, the concentration of carfentrazone-ethyl and degradates on day zero was 409 μg/L. The time weighted average of carfentrazone-ethyl plus degradates in treated rice water was 14.2 μg/L. Assuming a two-fold dilution of paddy water into receiving waters, the acute and chronic surface water concentration for carfentrazone-ethyl and its degradates, as a result of the application to a flooded rice field, are 205 μg/L and 7.1 μg/L.

i. Acute exposure and risk. For the acute scenario, the drinking water levels of comparison (DWLOCs) are 170,000, 50,000, 50,000 and 50,000 parts per billion (ppb) for the U.S. population, all infants (less than 1 year), children (1-6 years), and children (7-12 years), respectively.

ii. Chronic exposure and risk. For the chronic scenario, the DWLOCs are 1,000, 290, 290, and 290 ppb for the U.S. population, all infants (less than 1 year), children (1-6 years), and children (7-12 years), respectively.

3. From non-dietary exposure. There are no registered or proposed residential uses for carfentrazone-ethyl.

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 carfentrazone-ethyl 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, carfentrazone-ethyl 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 carfentrazone-ethyl 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).

Aggregate exposures are calculated by summing dietary (food and water) and residential exposures. Carfentrazone-ethyl is not registered for residential uses. Therefore aggregate exposures are only concerned with food and water. Since EPA does not have ground and surface water monitoring data to calculate a quantitative aggregate exposure, drinking water levels of comparison (DWLOC) were calculated. The DWLOC is the theoretical upper limit of a chemical's concentration in drinking water that will result in an aggregate exposure less than a specified PAD. The DWLOC is used as a point of comparison against model estimates of a pesticide's concentration in water. DWLOC values are not regulatory standards for drinking water.

1. Acute risk. The acute dietary exposure analysis assumed tolerance level residues and 100% crop treated for all registered and proposed commodities (Tier 1). Dietary exposures from food for all population subgroups were less than 1% of the aPAD. The DWLOC for the U.S. population is 170,000 ppb. The EECs for surface water (205 ppb) and ground water (6.6 ppb) are less than the DWLOC. Therefore, acute exposure to carfentrazone-ethyl, as a result of all registered and proposed uses, is below the Agency's level of concern.

2. Chronic risk. The chronic dietary exposure analysis assumed tolerance level residues and 100% crop treated for all registered and proposed commodities (Tier 1). Dietary exposures from food for all population subgroups were less than or equal to 3% of the cPAD. The DWLOC for the U.S. population is 1,000 ppb. The EECs for surface water (7.1 ppb) and ground water (6.6 ppb) are less than the DWLOC. Therefore, chronic exposure to carfentrazone-ethyl, as a result of all registered and proposed uses, is below the Agency's level of concern.

3. Short- and intermediate-term risk. The Agency concludes with reasonable certainty that residues of carfentrazone-ethyl and its chloropropionic acid metabolite would not result in unacceptable levels of short- and intermediate-term human health risk. There are no residential uses or exposure scenarios and no toxicological endpoints were identified for short- and intermediate-term exposure scenarios.

4. Aggregate cancer risk for U.S. population. Carfentrazone-ethyl is classified as a “not likely” human carcinogen according to EPA's Proposed Guidelines for Carcinogen Risk Assessment (April 10, 1996).

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to carfentrazone-ethyl residues.

1. Safety factor for infants and children —i. In general. In assessing the potential for additional sensitivity of infants and children to residues of carfentrazone-ethyl, EPA considered data from developmental toxicity studies in the rat and rabbit and a 2-generation reproduction study in the rat. The developmental toxicity studies are designed to evaluate adverse effects on the developing organism resulting from maternal pesticide exposure gestation. Reproduction studies provide information relating to effects from exposure to the pesticide on the reproductive capability of mating animals and data on systemic toxicity.

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 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. EPA believes that reliable data support using the standard uncertainty factor (usually 100 for combined interspecies and intraspecies variability) and not the additional tenfold MOE/uncertainty factor when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor.

ii. Prenatal and postnatal sensitivity. There was no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to the chemical. The toxicological data base is complete.

iii. Conclusion. There is a complete toxicity data base for carfentrazone-ethyl, and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that a 10x safety factor was not required. The rationale is based on the following: there was no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to the chemical; the toxicological data base is complete; and the fact that there are no registered residential products, in conjunction with the use of generally high quality data, conservative models and/or assumptions in the exposure assessment provide adequate protection for infants and children.

2. Acute risk. Dietary exposure for all of the population subgroups were less than 1% of the aPAD. Surface water and ground water EECs for all population subgroups were 205.0 and 6.6 ppb, respectively. The acute DWLOC for the subgroups: All infants (less than 1-year), children (1-6 years), children (7-12 years) was 50,000 ppb. Since the EECs are less than the DWLOC, acute exposure to carfentrazone-ethyl, as a result of all registered and proposed uses, is below the Agency's level of concern.

3. Chronic risk. Dietary exposure for all of the population subgroups were less than 3% of the cPAD. Surface water and ground water EECs for all population subgroups were 7.1 and 6.6 ppb, respectively. The chronic DWLOC for the subgroups: All infants (less than 1-year), children (1-6 years) and children (7-12 years) was 290 ppb. Since the EECs are less than the DWLOC, chronic exposure to carfentrazone-ethyl, as a result of all registered and proposed uses, is below the Agency's level of concern.

4. Short- or intermediate-term risk. There are no residential uses or exposure scenarios and no toxicological endpoints were identified for short- and intermediate-term exposure scenarios.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to carfentrazone-ethyl residues.

Metabolism studies performed on soybeans, corn, wheat, lactating goats, and laying hens were previously reviewed and presented to the Metabolism Assessment and Review Committee (MARC). The MARC determined that considering the crops for which the petitioner was requesting registration (corn, wheat, soybeans), the appropriate tolerance expression for livestock and plant commodities was carfentrazone-ethyl and its chloropropionic acid metabolite (F8426-CIPAc). In addition, these two compounds were sufficient for the dietary risk assessment. However, since the hydroxyl metabolite, 3-OH-F8426-Cl-PAc, was found as the major residue in soybean forage and hay, the registrant was instructed to monitor for this metabolite in all field trials of additional future crops.

There is a practical method for detecting and measuring levels of carfentrazone-ethyl and its metabolites in or on food with a limit of detection that allows monitoring of food with residues at or above the levels set in these tolerances. The proposed analytical method for determining residues is hydrolysis followed by gas chromatography with electron capture detection for the parent, and hydrolysis and derivitization followed by gas chromatography with mass selective detection for the metabolites.

The method may be requested from: The Analytical Chemistry Branch (ACB), BEAD (7503C), Environmental Science Center, 701 Mapes Road, Fort George G. Meade, MD 20755-5350; contact Francis D. Griffith, Jr. telephone (410) 305-2905, e-mail: griffith.francis@epa.gov. The analytical standards for these methods are also available from the EPA National Pesticide Standard Repository at the same location.

The residue data submitted support the establishment of the following tolerances; grain, cereal, group at 0.10 ppm; grain, cereal, forage (excluding corn and sorghum) at 1.0 ppm; grain, cereal, straw (excluding rice) at 0.10 ppm; grain, cereal, stover at 0.30 ppm; grain, cereal, hay at 0.30 ppm; corn, field, forage at 0.20 ppm; corn, sweet, forage at 0.20 ppm; sorghum, forage at 0.20 ppm; rice, straw at 1.0 ppm; corn, sweet, kernel plus cob with husk removed at 0.10 ppm.

There are no Codex, Canadian, or Mexican tolerances or maximum residue limits established for carfentrazone-ethyl in/on cereal grains. There are no compatibility problems that exists between the proposed U.S. and Codex tolerances.

Based on the confined accumulation in rotational crops study, the MARC determined that the carfentrazone-ethyl and F8426-CIPAc are the residues of concern in rotational crops. The committee also expressed concern for the residues of the benzoic acid compounds if the levels found are similar to or greater than the parent and the metabolite. The confined rotational crop study demonstrated that the combined residues of carfentrazone-ethyl and the chloropropionic acid metabolite were less than 0.01 ppm at all plant-back intervals for lettuce, radishes, wheat grain, and wheat forage. Parent was found at detectable levels in wheat straw at 32 days after treatment (DAT: 0.012-0.013 ppm) and at 277 DAT (0.017-0.048 ppm). Based on the confined rotational crop study, the labeling will require the following rotational crop restrictions are appropriate: soybean and cereal grains—no waiting period, root and leafy vegetables—30 days; all other crops—12 months.

Therefore, the tolerances are established for combined residues of carfentrazone-ethyl (ethyl-alpha-2-dichloro-5-[-4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-1yl]-4-fluorobenzene-propanoate) and its metabolite: carfentrazone-chloropropionic acid (alpha, 2-dichloro-5-[4-difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1 H -1,2,4-triazol-yl]-4-fluorobenzenepropanoic acid) in or on grain, cereal, group at 0.10 ppm; grain, cereal, forage (excluding corn and sorghum) at 1.0 ppm; grain, cereal, straw (excluding rice) at 0.10 ppm; grain, cereal, stover at 0.30 ppm; grain, cereal, hay at 0.30 ppm; corn, field, forage at 0.20 ppm; corn, sweet, forage at 0.20 ppm; sorghum, forage at 0.20 ppm; rice, straw at 1.0 ppm; corn, sweet, kernel plus cob with husk removed at 0.10 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA 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-301025 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 October 10, 2000.

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, 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-301025, 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 file format 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, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under 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. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

You may be 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 under FOR 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 the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301033. 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 the Federal Register of May 20, 1998 (63 FR 27723-27727) (FRL-5773-2), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the FQPA (Public Law 104-170) announcing the filing of a pesticide petition (PP) for tolerance by Novartis Crop Protection, Inc. of Greensboro, NC 27419. This notice included a summary of the petition prepared by Novartis Crop Protection, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.556 be amended by establishing a tolerance for residues of the insecticide pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino], in or on hops at 5 ppm, fruiting vegetables at 0.05 ppm, and cucurbits and potatoes at 0.02 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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 a tolerance for residues of pymetrozine, 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] on cucurbit vegetables (Crop Group 8) at 0.05 parts per million (ppm) and fruiting vegetables at 0.05 ppm. EPA's assessment of the dietary 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 pymetrozine, 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] are discussed in this unit or in a previous Federal Register notice.

1. Acute toxicity . In general, technical pymetrozine has low acute toxicity, being classified as Toxicity Category III for acute dermal and primary eye irritation studies and Toxicity Category IV for acute oral, acute inhalation and primary dermal studies. It is a slight sensitizer.

2. Subchronic and chronic toxicity . EPA's September 29, 1999, Federal Register notice (64 FR 52438-52450) (FRL-6385-6) summarized the results of the subchronic and chronic toxicity, metabolism, and dermal penetration studies in animals.

EPA's September 29, 1999, Federal Register notice (64 FR 52438-52450) (FRL-6385-6) discussed the toxicological endpoints in detail and will not be repeated here.

1. Current and proposed uses. Pymetrozine is an insecticide of the pyridine azomethine type and was first registered in 1999. Pymetrozine controls aphids and suppression of whiteflies in a variety of crops. The mode of action of pymetrozine has not been precisely determined biochemically; physiologically, it appears to act by preventing these insects from inserting their stylus into the plant tissue.

Currently, EPA has registered pymetrozine for use on tuberous and corm vegetables (Subgroup 1-C) and tobacco under Fulfill® (EPA Reg. No. 100-912) and ornamental plants under Endeavor® (EPA Reg. No. 100-913). There are no homeowner applications for pymetrozine. However; postapplication (residential) exposure could occur due to contact with treated ornamental plants. For both Fulfill® and Endeavor® , pymetrozine is formulated as a water-dispersible granule containing 50%% active ingredient.

Fulfill® may be applied by either ground or aerial broadcast equipment, in a minimum of 10 gallons of water per acre; chemigation is not permitted. Pymetrozine is applied to the foliage of affected plants where it is quickly absorbed. Potato and tobacco crops may be treated up to twice, each at a maximum rate of 0.09 lb active ingredient/acre (ai/A). The maximum seasonal use rate is 0.17 lb ai/acre. The retreatment and pre-harvest intervals are 7 and 14 days, respectively. The label for Fulfill® specifies a restricted-entry interval of 12 hours.

Endeavor® may be broadcast-applied to ornamentals at a rate not to exceed 10 ounce/acre/application (oz./A/application). Multiple applications may be made on a 7- to14-day interval. For indoor use, the yearly application rate is not to exceed 100 oz./A/year; for outdoor use, the maximum rate is 48 oz./A/year.

Novartis Crop Protection has proposed that the use of pymetrozine be expanded on the Fulfill® label to included cucurbit and fruiting vegetables. The rates, number of applications, pre-harvest intervals, and restricted-entry interval will remain the same for these additional uses.

2. From food and feed uses . This Rule establishes two new tolerances for pymetrozine: in or on cucurbit vegetables (Crop Group 8) at 0.05 parts per million (ppm) and fruiting vegetables (Crop Group 9) at 0.05 ppm.

Section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide chemicals that have been measured in food. If EPA relies on such information, EPA must require that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. Following the initial data submission, EPA is authorized to require similar data on a time frame it deems appropriate. As required by section 408(b)(2)(E), EPA will issue a data call-in for information relating to anticipated residues to be submitted no later than 5 years from the date of issuance of this tolerance.

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of crop treated (PCT) for assessing chronic dietary risk only if the Agency can make the following findings: That the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; that the exposure estimate does not underestimate exposure for any significant subpopulation group; and if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

Most of the dietary risk assessments performed on pymetrozine used a Tier 1 approach for fruiting vegetables, cucurbits, and potatoes, crops originally requested in the petition. That is, the Agency assumed 100%% crop treated and tolerance level residues. For carcinogenicity risk assessment, the Agency used a Tier 3 chronic dietary exposure analysis for fruiting, cucurbit, and tuberous and corm vegetables. This was based on 6-20%% of the crop treated and an anticipated residue of 0.0046 ppm to refine the cancer risk. Novartis supplied this estimate of PCT to the Agency. The Agency reviewed Novartis' estimate and found it reasonable.

The Agency believes that the three conditions, discussed in section 408 (b)(2)(F) in this unit concerning the Agency's responsibilities in assessing chronic dietary risk findings, have been met. EPA finds that the PCT information is reliable and has a valid basis. Before the petitioner can increase production of product for treatment of greater than 340,000 acres (20%% of 1,700,000 total acres for fruiting, cucurbit, and the tuberous and corm subgroup), permission from the Agency must be obtained. The regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the consumption of food in a particular area.

i. Acute exposure and risk . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

The Tier 1 DEEM® analysis indicates that acute dietary (food only) exposure to pymetrozine from all existing and proposed uses (tuberous and corm, fruiting, and cucurbit vegetables) will be below EPA's level of concern (100%% of the acute Population‐Adjusted Dose (aPAD)) and will not occupy more than 7%% of the aPAD for any population subgroup, including those of infants and children. For the maximum exposed subgroup, the 95th percentile of exposure (children ages 1-6 years) is predicted to be 3.3%% of the aPAD. Due to pymetrozine's lower acute endpoint for females 13-50 years (0.033 mg/kg) versus that of other population subgroups (0.14 mg/kg), the percentage of the aPAD occupied for females 13-50 years (6.5%%) is slightly higher than that estimated for children 1-6 years. For a Tier 1 analysis, EPA considers exposure at the 95th percentile of exposure. Even at the 99.9th percentile of exposure, the acute risk is well below EPA's level of concern.

ii. Chronic exposure and risk . The Tier 1 DEEM® chronic analysis indicates that exposure to pymetrozine from tuberous and corm vegetables, cucurbits, and fruiting vegetables will occupy less than 74%% of the chronic Population-Adjusted Dose (cPAD) for children ages 1-6 (the most highly exposed population subgroup). Chronic dietary risk to all other subgroups is less than that of children ages 1-6. See Table 1 below.

iii. Cancer exposure and risk . The Agency used a Tier 3 DEEM® analysis for cancer risk estimates to the U.S. population. Based on use of pymetrozine on tuberous and corm vegetables, fruiting vegetables, and cucurbits vegetables, the food only cancer risk is 1 × 10 -7 , which is below the Agency's level of concern.

3. From drinking water . Pymetrozine is not persistent, breaking down in the environment through a number of mechanisms and degradation pathways including hydrolysis and aqueous and soil photolysis. Laboratory studies indicate that pymetrozine is a “low mobility” to “no mobility” chemical with respect to leaching. The environmental fate profile and application rates suggest that there should not be any notable concerns in the areas of soil mobility and persistence for pymetrozine resulting from its agriculture use to control aphids and whiteflies. Based on the low application rate, the field dissipation data, and the minimal concentrations relative to the parent (less than 10%%, total), pymetrozine degradates should not enter ground and surface water to any appreciable extent.

EPA used the Screening Concentration In GROund Water (SCI-GROW) model to predict the Environmental Estimated Concentrations (EEC's) for pymetrozine in ground water. SCI-GROW is a regression model based on actual groundwater monitoring data. SCI-GROW appears to provide realistic estimates of pesticide concentrations in shallow, highly vulnerable ground water sites. Using the highest application rate of 0.187 lb ai/A (hops), SCI-GROW estimates the concentration of pymetrozine in groundwater to be 0.015 μg/L. As there is relatively little temporal variation in ground water, this estimate can be used for both acute and chronic exposure scenarios.

In addition, EPA used the Tier 2 GENeric Estimated Environmental Concentration (GENEEC) and Pesticide Root Zone Model-EXAMS (PRZM-EXAMS) model to obtain EEC's in surface water. The standard PRZM-EXAMS runoff modeling scenario is based on a 10 hectares (ha) field draining into a 1 ha by 2 meter deep small water body. This scenario represents a watershed drainage area: water volume ratio of 5 m 2 /m 3 . Each PRZM modeling scenario represents a unique combination of climatic conditions (e.g., rainfall), crop specific management practices, soil specific properties, site specific hydrology, and pesticide specific application and dissipation processes. Each PRZM simulation is conducted for multiple years to provide a probabilistic exposure characterization for a single site.

Based on the maximum use pattern for any of the requested crops (hops at 0.56 lb ai/A/season), the GENEEC-estimated 56-day surface water EEC is 2.29 μg/L. Actual chronic surface water concentrations are likely to be less than this estimated 56-day average. Because the DWLOC exceeds the chronic EEC, the Agency believes that the aggregate risk from exposure to pymetrozine due to the proposed uses on tuberous and corm, fruiting, and cucurbit vegetables is not likely to exceed our level of concern. The DWLOCs for acute, short-term, and chronic exposure have not changed from those detailed in the risk assessment; all remain greater than the Tier 1 EEC values.

The EEC's for surface water (2.29 μg/L) are higher than those for groundwater (0.015 μg/L). Therefore, surface water EEC's will be used:

(1) To estimate actual concentrations of pymetrozine in water.

(2) To compare those concentrations with the Drinking Water Levels of Comparison (DWLOCs) in μg/L.

i. Acute exposure and risk . For acute aggregate exposure scenarios, the DWLOC values (930-15,000 μg/L) are all in excess of the modeled acute EEC values (4.0 μg/L); thus, drinking water is not expected to be a significant contributor towards this type of exposure.

ii. Chronic exposure and risk . For chronic (non-cancer) aggregate exposure scenarios, the DWLOC values (3.4-120 μg/L) are all in excess of the modeled EEC values (2.29 μg/L); thus, drinking water is not expected to be a significant contributor towards this type of exposure.

iii. Cancer exposure and risk . For cancer aggregate exposure scenarios, the DWLOC value of 2.6 μg/L is in excess of the modeled EEC values (2.29 μg/L). EPA has calculated the cancer risk resulting from 2.29 μg/L in drinking water, a dose of 0000654 mg/kg/day, to be 6.54 × 10 -7 . Thus, drinking water alone does not exceed EPA's level of concern (in the range of 1 × 10 -6 ) and is not expected to be a significant contributor towards cancer risk.

4. From non-dietary exposure . As currently proposed, pymetrozine could be used on the following residential non-food sites: ornamentals (landscape, ground-covers, interiorscapes); home nurseries, non-bearing orchards, and greenhouses. The end-use product, Endeavor®, may not be applied by homeowners, but post-application exposure could occur. There are no intermediate-term exposure scenarios for which a risk assessment is required. Short-term exposures are not applicable for adults but are applicable for toddlers.

Since there was no chemical specific data to determine dislodgeable residues, the EPA used its Standard Operating Procedures (SOPs) for Residential Exposure Assessment (Draft, December 18, 1997) to estimate postapplication exposure. This Standard Operating Procedure (SOP) does not include a scenario for ornamentals, landscapes and groundcover. Therefore, this assessment used the garden plants scenarios to determine postapplication exposures.

The postapplication scenarios and associated Margins of Exposure (MOEs) included:

(1) Incidental non-dietary hand-to-mouth transfer of pesticide residues (770,000).

(2) Incidental non-dietary ingestion of pesticide-treated plants (not significant).

(3) Incidental non-dietary ingestion of soil from pesticide-treated areas (660,000).

The following assumptions were used for estimating postapplication for the three post-application scenarios.

(a) Hand-to-mouth transfer (incidental non-dietary ingestion) .

• Maximum application rate of 0.3125 lbs ai per acre as specified on the label

• Twenty percent of the application rate are available on the foliage as dislodgeable residue

• Exposure is assessed on the same day the pesticide is applied

• Medium surface area of both hands is 350 cm 2 for a toddler (age 3 yrs old)

• Mean rate of hand-to-mouth activity is 1.56 events/hr

• Duration of exposure was assumed to be 0.18 hrs/day (10 mins) for toddlers

• A body weight of 15 kg was assumed for toddlers

• Short term NOAEL = 10 mg/kg/day (acute dietary);

• Hand-to-mouth exposure is not considered an intermediate-term exposure scenario

(b) Accidental ingestion of plant material .

• According to the HED SOP for Residential Exposure, exposure via this route is considered negligible.

(c) Accidental ingestion of soil .

• Maximum application rate of 0.3125 lbs ai per acre as specified on the label

• Twenty percnt; of the application rate are available on the foliage as dislodgeable residue

• Exposure is assessed on the same day the pesticide is applied

• The fraction of ai available in uppermost centimeter of soil is 1 cm

• The assumed soil ingestion rate for children (ages 1-6 yrs) is 100 mg/day

• A body weight of 15 kg was assumed for toddlers

• Short term NOAEL = 10 mg/kg/day (acute dietary);

• Exposure from soil ingestion is not considered an intermediate-term exposure scenario.

These exposure estimates are based on upper-percentile (i.e., maximum application rate, available residues and duration of exposure) and some central tendency (i.e., transfer coefficient, surface area, hand-to-mouth activity, and body weight) assumptions and are considered to be representative of high-end exposures. The uncertainties associated with this assessment stem from the use of an assumed amount of pesticide available from gardens, and assumptions regarding dissipation, transfer of chemical residues, and hand-to-mouth activity. The estimated exposures are believed to be reasonable high-end estimates based on observations from chemical-specific field studies and professional judgement.

EPA determined that the FQPA Safety Factor to protect infants and children should be reduced to 3x and that the factor should apply to female (13-50 years), infant, and children population subgroups for all risk assessments. Thus, the levels of concern for these postapplication exposure scenarios are MOEs that are less than 100 for adult populations and less than 300 for female (13-50), infant, and children populations.

i. Chronic exposure and risk . Based on the proposed uses of pymetrozine, EPA does not believe there will be chronic non-occupational exposure to this insecticide.

ii. Cancer exposure and risk . The EPA has estimated the lifetime average daily dose for non-occupational exposure resulting from prining and planting treated ornamental plants is 0.0000012 mg/kg/day.

A quantitative cancer risk assessment was performed for postapplication non-occupational exposure to treated ornamentals (e.g., a home garden). Exposures were estimated using EPA's default activity scenarios, transfer coefficients and input parameters as follows: The fraction of active ingredient retained on foliage is assumed to be 20%% (0.2) on day zero (= percent dislodgeable foliar residue, DFR, after initial treatment). This fraction is assumed to further dissipate at the rate of 10%% (0.1) per day on following days. These are EPA's default values for exposure.

• An application rate of 0.3125 lbs ai/acre (electrostatic spray, pulsfog and low volume systems) was used to represent the worst case scenario.

• Transfer coefficient of 4,500 was used to represent heaviest day of activity (planting, transplanting, and pruning) for contact with treated ornamental plants

• Assumed homeowner worked 0.67 hours per day (Residential SOP for Gardening)

• Assumed homeowner worked a total of 2 days per year performing heaviest activities (planting, pruning) at time points shortly after pymetrozine application

• Assumed homeowner would be exposed for 50 years of their life

• Dermal absorption = 1%%

• Body weight = 70 kg

• Life expectancy = 70 years

• Cancer Q * (mg/kg/day) = 1.19 × 10 -2

The cancer risk estimate for this postapplication exposure is 1.4 × 10 -8 and does not exceed EPA's level of concern (in the range of 1 × 10 -6 ) for the general population.

iii. Short- and intermediate-term exposure and risk . EPA did not calculate margins of exposure (MOEs) for adults since there are no short-term dermal exposure scenarios. However, short-term oral exposures and risks were calculated for toddlers. For toddlers, the MOEs for short-term postapplication exposure scenarios are 770,000 and 660,000 for hand-to-mouth and soil ingestion scenarios. These values are all greater than either of the threshold values; thus, short-term risks are below the Agency's level of concern.

5. 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.”

According to our information, there are no other pesticides that have a common mechanism of toxicity with pymetrozine. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, pymetrozine 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 pymetrozine 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. Acute risk . The risk from aggregate acute exposure from food and drinking water from pymetrozine is below EPA level of concern for the following reasons. As indicated in Table 2, the Tier 1 Dietary Exposure Evaluation Model (DEEM®) analysis indicates that acute dietary (food only) exposure to pymetrozine from fruiting vegetables, cucurbits, and tuberous and corm vegetables (Subgroup 1-C) will occupy less than 1/2%% (0.001980/0.42) of the aPAD for the U.S. population, which is below EPA's level of concern of 100%% of the aPAD. In addition, for drinking water, the DWLOC value (15,000 μg/L) for the U.S. population is greatly in excess of the modeled acute EEC value (1.9 μg/L); thus, drinking water is not expected to be a significant contributor towards this type of exposure.

2. Chronic risk . As indicated in Table 1, the Tier 1 DEEM analysis indicates that chronic dietary (food only) exposure to pymetrozine will utilize less than 12%% (0.000455/0.0038) of the chronic Population-Adjusted Dose (cPAD) for the U.S. population. EPA generally has no concern for exposures below 100%% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. In addition, for drinking water, the DWLOC value (120 μg/L) for the U.S. Population is greatly in excess of the modeled EEC values (2.29 μg/L); thus, drinking water is not expected to be a significant contributor towards this type of exposure. Despite the potential for exposure in the diet, drinking water, and from non-dietary, non-occupational exposure, EPA does not expect the aggregate chronic exposure to exceed 100%% of the cPAD.

3. Aggregate cancer risk for U.S. population . For fruiting vegetables, cucurbits, and tuberous and corm vegetables, EPA based its cancer risk assessment on a Tier 3 estimate of dietary exposure, which incorporates anticipated residues (0.0046 ppm) for pymetrozine and an estimate for percent crop treated. At this level of refinement, EPA's estimates of food exposure and cancer risk were 0.000008 mg/kg/day and 1 × 10 -7 ) (in the range of 1 × 10 -6 . The EPA also calculated a lifetime average daily dose of 0.0000012 mg/kg/day for non-occupational exposure resulting from pruning and planting treated ornamental plants, resulting in a cancer risk from this type of exposure of 0.143 × 10 -7 ). For drinking water, the cancer dose was 0.0000654 mg/kg/day, and the cancer risk was 8 × 10 -7 ).

The aggregate cancer risk for all exposures, even including water is 0.9 × 10 -6 ) , which is below the Agency's level of concern.

4. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to pymetrozine 1,2,4-triazin-3(2H)-one,4,5-dihydro-6-methyl-4-[(3-pyridinylmethylene) amino] residues.

1. Safety factor for infants and children —i. In general . In assessing the potential for additional sensitivity of infants and children to residues of pymetrozine, EPA considered data from developmental toxicity studies in rabbit, an acute neurotoxicity study in the rat, and a chronic feeding study in the rat. See the Toxicological Profile (Unit III.A) for a discussion of these tests.

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 pre-and post-natal toxicity and the completeness of the database 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. EPA believes that reliable data support using the standard uncertainty factor (usually 100 for combined inter- and intra-species variability) and the additional 3-fold MOE/uncertainty factors, as described above, when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of these safety factors.

ii. Conclusion . EPA considered the available data and determined that the 10-fold FQPA factor could be reduced to 3.

2. Acute risk . The risk from aggregate acute exposure from food and drinking water from pymetrozine is below EPA level of concern for the following reasons. The Tier 1 Dietary Exposure Evaluation Model (DEEM®) analysis indicates that acute dietary (food only) exposure to pymetrozine from tuberous and corm vegetables (Subgroup 1-C), fruiting vegetables and cucurbits will occupy less than 4%% (0.004556/0.14) of the aPAD for children (1 to 6 years old), which is below EPA's level of concern of 100%% of the aPAD. In addition, for drinking water, the DWLOC value (1,400 μg/L) for children (1 to 6 years old) is greatly in excess of the modeled acute EEC values (1.9 μg/L); thus, drinking water is not expected to be a significant contributor towards this type of exposure.

3. Chronic risk . Using the residue concentration exposure assumptions described in this unit, the risk from aggregate chronic exposure from food and drinking water from pymetrozine is below EPA's level of concern for the following reasons. As indicated in Table 1 above, the Tier 1 DEEM analysis indicates that chronic dietary (food only) exposure to pymetrozine will utilize less than 74%% (0.000958/0.0013) of the cPAD for children (1 to 6 years old). EPA generally has no concern for exposures below 100%% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. In addition, for drinking water, the DWLOC value (3.4 μg/L) for children (1 to 6 years old) exceeds the modeled chronic EEC values (0.222 μg/L); thus, drinking water is not expected to be a significant contributor towards this type of exposure. Despite the potential for exposure from food, drinking water and non-dietary, non-occupational exposure, EPA does not expect the aggregate chronic exposure to exceed 100%% of the cPAD.

4. Short-term risk . In aggregating short-term risk, EPA considered background average dietary exposure and short-term, non-dietary oral exposure. Non-dietary oral exposure may occur as hand-to-mouth transfer of residues from ornamental plants or incidental ingestion of surrounding soil. The lowest short-term MOE value is for toddlers. Combining this MOE (660,000) with that from dietary exposure (Short-term oral NOAEL/chronic dietary exposure = 10/0.00096 ≉ 10,000) results in an aggregate MOE of ≉ (approximately equal) 10,000. As this value is greater than 300, the short-term aggregate risk is below the Agency's level of concern. Aggregated short-term exposure results in a DWLOC of 320 μg/L. This value is in excess of the peak EEC for pymetrozine (1.9 μg/L; see Table 2).

5. Determination of safety . Based on these risk assessments, EPA concludes that there is a reasonable certainty of no harm to infants and children from aggregate exposure to pymetrozine residues.

Data concerning the metabolism of pymetrozine in plants and animals have been previously submitted. The nature of residues in plants and animals is adequately understood. The tolerance expression is for pymetrozine per se. The residues of concern for risk assessment are pymetrozine; the plant metabolites GS-23199 [6-methyl-1,2,4-triazin-3,5 (2H,4H)-dione], CGA-215525 [4-amino-4,5-dihydro-6-methyl-1,2,4-triazin-3(2H)-one], CGA-249257 [4,5-dihydro-6-methyl-1,2,4-triazin-3(2H)-one], CGA-294849 [4-amino-6-methyl-1,2,4-triazin-3,5(2H,4H)-dione]; and the ruminant metabolite CGA-313124 [4,5-dihydro-6-hydroxymethyl-4-[(3-pyndynyl methylene)amino]-1,2,4-triazin-3(2H)-one] (free acid conjugated).

Adequate enforcement methodology for pymetrozine (Novartis Analytical Method AG-643) is currently being validated. Following validation, it will be available to enforce the tolerance expression. At that time the method may be requested from: Calvin Furlow, PIRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

The crop field trial data support the proposed tolerances for residues of “pymetrozine, per se.”

There are no established European (CODEX), Canadian, or Mexican Maximum Residue Limits (MRL's) for pymetrozine. There are provisional MRLs in Germany for hops (10 ppm) and potatoes (0.02 ppm). The European Union is currently evaluating a proposed tolerance of 5 ppm on hops. At this time, international harmonization of residue levels is not an issue.

The Fulfill® label reads as follows: “The rotational (plantback) restrictions for Fulfill are 30-days for all crops.”

The pre-harvest interval for pymetrozine on the tuberous and corm, fruiting, and cucurbit vegetables is 14 days.

Therefore, EPA is establishing tolerances for residues of pymetrozine per se in cucurbit vegetables (Crop Group 8) at 0.05 ppm and fruiting vegetables (Crop Group 9) at 0.05 ppm.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA 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-301033 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 October 10, 2000.

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 Avenue, NW, Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Room M3708, 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 be 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, 401 M St., SW., 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, 401 M St., SW., 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 PIRB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket number OPP-301033, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PRIB 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 file format 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, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under 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. 601 et seq .) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

You may be 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 under FOR 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 the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301035. 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.

EPA issued a final rule, published in the Federal Register of November 29, 1996 (FRL-5575-1), which announced that on its own initiative under section 408 of the FFDCA, 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established time-limited tolerances for the residues of imidacloprid and its metabolites in or on turnip roots at 0.3 ppm, turnip tops at 3.5 ppm, beet roots at 0.3 ppm, and beet tops at 3.5 ppm, with an expiration date of November 29, 1997. EPA established the tolerances because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of the FIFRA. Such tolerances can be established without providing notice or period for public comment. These tolerances were extended on December 12, 1997 (FRL-5760-9) for an additional 12-month period to November 29, 1998. These tolerances were further extended on October 7, 1998, (FRL-6037-2) for an additional 18-month period to June 30, 2000.

EPA received a request to extend the use of imidacloprid on turnip greens and garden beets for this year's growing season due to the continuing emergency situation in California and a new one in Arizona. According to the applicants, due to the lack of acceptable control with currently registered products, and the loss of the insecticide phosdrin, this pest has become a serious threat to the table beet and turnip green industry. Aphids can cause serious reductions due to contamination problems resulting from the large number of aphids remaining on the crop at harvest. The market will only allow 2 aphids or less per plant. After having reviewed the submissions, EPA concurs that emergency conditions exist. EPA has authorized under FIFRA section 18 the use of imidacloprid on turnip greens for control of aphids in Arizona and California and for use on garden beets for control of aphids in California.

EPA assessed the potential risks presented by residues of imidacloprid in or on turnip greens and garden beets. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerances under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule of November 29, 1996 (FRL-5575-1). Based on that data and information considered, the Agency reaffirms that extension of the time-limited tolerances will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited tolerances are extended for an additional 2-year period. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations (CFR). Although these tolerances will expire and are revoked on June 30, 2002, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on turnip greens and garden beets after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the tolerances. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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-301035 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 October 10, 2000.

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 III. 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-301035, 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 file format 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 time-limited tolerances under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review October 4, 1993, (58 FR 51735). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments May 19, 1998, (63 FR 27655); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks 62 FR 19885, April 23, 1997. This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601) et seq. do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism August 10, 1999, (64 FR 43255). 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).

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

You may be 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 under FOR 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 the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-301031. 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.

EPA issued a final rule, published in the Federal Register of December 3, 1997 (62 FR 63858) (FRL-5754-1), which announced that on its own initiative under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) it established a time-limited exemption from the requirement of a tolerance for the residues of sodium chlorate in or on wheat, with an expiration date of July 31, 1998. EPA extended the expiration date of this exemption to January 31, 2000 in a Federal Register notice published July 1, 1998 (63 FR 37280) (FRL-5795-8). Subsequently, the expiration date of this exemption was re-extended to July 31, 2001 in a Federal Register notice published August 6, 1999 (64 FR 42849) (FRL-6091-6). EPA established the exemption from the requirement of a tolerance because section 408(l)(6) of the FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Such tolerances can be established without providing notice or period for public comment.

EPA assessed the potential risks presented by residues of sodium chlorate in or on wheat. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. The data and other relevant material have been evaluated and discussed in the final rule of December 3, 1997 (62 FR 63858). Based on that data and information considered, the Agency reaffirms that extension of the exemption from time-limited tolerance will continue to meet the requirements of section 408(l)(6). Therefore, the time-limited exemption from the requirement of a tolerance is extended for an additional 1 1/2 year period. EPA will publish a document in the Federal Register to remove the revoked exemption from the requirement of a tolerance from the Code of Federal Regulations (CFR). Although this exemption from the requirement of a tolerance will expire and is revoked on December 31, 2002, under FFDCA section 408(l)(5), residues of the pesticide remaining in or on wheat after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA and the application occurred prior to the revocation of the exemption from the requirement of a tolerance. EPA will take action to revoke this exemption from the requirement of a tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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-301031 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 October 10, 2000.

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 III.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-301031, 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 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a time-limited exemption from the requirement of a tolerance under FFDCA section 408. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any prior consultation as specified by Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998); special considerations as required by Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 petition under FFDCA section 408, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

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

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-116, adopted June 21, 2000, and released June 30, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

This item also corrects the typographical error in 47 CFR 73.202 which incorrectly listed Channel 260 at Taos, NM without a class designation from 1992 to current. 56 FR 16013 (April 1991.) That listing is hereby corrected to read Channel 260C and is further amended in this item to Channel 256C at Taos.