This rule is issued under Marketing Agreement No. 155 and Marketing Order No. 928, both as amended (7 CFR part 928), regulating the handling of papayas grown in Hawaii, hereinafter referred to as the “order.” The marketing agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with the Secretary a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing the Secretary would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review the Secretary's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule continues in effect the suspension of three sections of the order's rules and regulations regarding minimum grade requirements (§ 928.313), maturity exemptions (§ 928.152), and inspection waiver procedures (§ 928.150). It also continues in effect the amendment of § 928.160 of the order's rules and regulations. The amendment to § 928.160 continues in effect the removal of references to mandatory regulations and relieves handlers from the requirement to add the inspection certificate number on PAC Form 1, Papaya Utilization.

This rule results from a unanimous recommendation of the committee at an emergency meeting on December 28, 2000. At that meeting, the committee recommended postponing, until July 1, 2001, the effective date of a final rule published by the Department on November 22, 2000, which reinstated grade, inspection, and related reporting requirements, effective January 2, 2001. The committee held a subsequent committee meeting on January 11, 2001, at which further public discussion was held. After considering the committee's recommendation and other relevant information, the Department is continuing in effect the suspension of the requirements that were reinstated on January 2, 2001, for an indefinite period.

Section 928.52 of the papaya marketing order authorizes the establishment of grade, size, quality, maturity, and pack and container regulations for shipments of papayas. Section 928.53 allows for the modification, suspension, or termination of such regulations when warranted. Section 928.55 provides that whenever papayas are regulated pursuant to §§ 928.52 or 928.53, such papayas must be inspected by the inspection service and certified as meeting the applicable requirements. The cost of inspection and certification is borne by handlers. Section 928.54 authorizes regulation exemptions when shipping papayas for commercial processing, relief agencies, or charitable institutions. In addition, the Secretary may relieve from any or all requirements under or established pursuant to §§ 928.41, 928.52, 928.53, and 928.55, the handling of papayas in such minimum quantities, in such types of shipments, or for such specified purposes (including shipments to facilitate the conduct of marketing research and development projects established pursuant to “ 928.45) as the committee, with the approval of the Secretary, may prescribe. Section 928.60 of the papaya marketing order authorizes handler reporting requirements.

This rule continues in effect the suspension of § 928.313 of the order's rules and regulations regarding minimum grade requirements. That section states that no handler shall ship papayas to any destination unless such papayas meet the minimum grade of Hawaii No. 1.

This rule also continues in effect the removal of the requirement that handlers obtain inspection through the Federal or Federal-State Inspection Service (inspection service) prior to shipment of fresh papayas. Suspension of the inspection waiver procedures in § 928.150 of the order's rules and regulations results in the elimination of the authority of the inspection service to grant inspection waivers. Inspection waivers allow handlers to ship papayas without inspection under certain conditions when it is not practicable for the inspection service to provide such inspection. In the absence of mandatory inspection, handlers do not need inspection waivers issued by the inspection service.

This rule also continues in effect the suspension of the maturity exemption and related reporting requirements in § 928.152 of the order's rules and regulations to remove the requirement that handlers interested in becoming handlers of immature papayas apply to the committee for approval, and report handling of immature papayas. Immature papayas are used in a popular dish called green papaya salad and as a vegetable substitute in recipes. Suspension of the maturity exemption and related reporting requirements also relieves handlers from filing PAC Forms 7 and 7(c) with the committee.

In addition, this rule continues in effect the amendment of § 928.160 to remove the references to mandatory regulations and the requirement that handlers include the number of the inspection certificate issued by the inspection service on each PAC Form 1 filed with the committee.

Grade, inspection, and reporting requirements under the order were suspended in 1994. As previously mentioned, in a final rule published on November 22, 2000, and effective January 2, 2001, the Department reinstated those requirements under §§ 928.150, 928.152, 928.313, and 928.160 of the order's rules and regulations.

The committee met on December 28, 2000, and voted unanimously to postpone the effective date until July 1, 2001. During that meeting, and a subsequent meeting on January 11, 2001, the committee noted that producer prices ranged from 6 to 12 cents per pound, compared to 25 to 45 cents per pound reported by the committee for the same period the previous year. Such prices, coupled with overproduction, have had a negative effect on the entire industry, especially for the new Rainbow variety of papayas. The Rainbow variety has been developed to tolerate the effects of the Papaya Ringspot Virus, which has decimated papaya trees in Hawaii for several years. The Rainbow variety, however, has not yet been approved for exportation to significant markets, especially Japan or Canada, and is only marketed in the United States.

Given the current marketing limitations and overproduction of papayas, the committee recommended that funds earmarked for inspection costs be redirected to marketing and promotion in an effort to increase demand and improve returns to producers. Currently, with low prices to producers, there is little money available for inspection. What funds are available, the committee believes, would best be utilized in increasing demand by enhanced marketing and promotion activities at this time. The committee proposed to review the condition of the industry in late spring or early summer to determine if overproduction eased or demand improved. Historically, the summer months result in lower production, due to the reduced availability of rainwater. This has been true for most varieties of papayas, and may also be true for the Rainbow variety. This information would place the committee in a better position to evaluate what further recommendations to make in the interests of the industry.

While the committee recommended a postponement of the effective date for implementing mandatory grade, inspection, and related reporting requirements until July 1, 2001, the Department believes that a suspension of the requirements is preferable. First, the emergency recommendation was made five days prior to the effective date of the regulations, January 2, 2001. Since that time inspections of papayas have not occurred. Second, the committee does not yet have a timetable for entry of the new Rainbow variety of papayas into the export markets to which the traditional variety, Kapoho, currently has entry. The committee believes increased demand would help absorb the current overproduction of the prolific Rainbow variety, and have a positive affect on producer returns. Third, the committee also believes that enhanced marketing and promotion may also improve demand for all fresh papayas. The committee believes that funds earmarked for inspection costs would be better utilized on promotional efforts. Thus, there would be no funds available later in the fiscal year for implementing mandatory inspection. There is no evidence that the conditions that currently exist in the industry would be greatly improved in the next several months.

For these reasons, the suspension of mandatory grade, inspection, and reporting requirements effective January 2, 2001, are continued in effect until such time as the conditions in the industry improve and the committee can demonstrate a long-term commitment to a quality control program.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), AMS has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 60 handlers of papayas in the production area and approximately 400 producers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $5,000,000.

Based on a reported current average f.o.b. price of $.65 per pound of papayas, a handler would have to ship in excess of 7.69 million pounds of papayas to have annual receipts of $5,000,000. Last year, only one handler shipped more than 7.69 million pounds of papayas, and, therefore, could be considered a large business. The remaining handlers could be considered small businesses, excluding receipts from other sources.

Based on a reported current average grower price of $0.09 per pound and annual industry shipments of 40 million pounds, total grower revenues would be $3.6 million. Average annual grower revenue would, thus, be $9,000. Based on the foregoing, the majority of handlers and producers of papayas may be classified as small entities, excluding receipts from other sources.

This rule continues in effect the suspension of the grade, inspection, and related reporting requirements under the order's rules and regulations. As a result, the suspension of §§ 928.150, 928.152, and 928.313 in their entirety is continued, and the amendment of § 928.160 is continued to remove the reference to mandatory regulations and the requirement that the inspection certificate number be added to the utilization reports filed by handlers.

At the meeting, the committee discussed the impact of these changes on handlers and producers in terms of cost. Since mandatory inspection and certification costs are borne by handlers, the cost savings to each handler are estimated to be a total $24.24 per hour for on-site inspections. In addition, the inspection service charges mileage costs of $.37 per mile round trip from the inspection service office to the handler's premises or processing plant. According to the inspection service, for a trip taking 10 or more minutes, or covering 7 or more miles, the travel time cost is based on the $24.24 hourly rate. Some handlers could pass the inspection costs onto producers, thus, further decreasing overall producer returns. These costs do not apply in the absence of minimum quality requirements and associated mandatory inspection.

During its deliberations, the committee discussed possible alternatives to this action. They deliberated the impacts of the final rule taking effect on January 2, 2001. However, because economic conditions in the papaya industry are currently at a historically low level, the committee rejected that alternative.

The committee also debated the value of suspending, rather than postponing, the regulations in their entirety. That alternative, however, was also rejected, as the committee felt suspension of the regulations was too drastic an action to take at the time. Instead, the committee proposed postponing the effective date of the requirements until July 1, 2001, and further reviewing the conditions within the industry at that time. The requirements were originally suspended beginning on July 1, 1994.

However, as noted earlier, the Department has determined that the suspension of the requirements is preferable and continues in effect, given the current industry conditions and likelihood that there will be no substantial improvement in the next several months. If industry conditions improve, implementation of the quality control program could again be recommended by the committee. Accordingly, this action will have a favorable effect on both large and small entities.

This rule continues in effect the relaxation of reporting requirements under the order, since PAC Form 1 will no longer require the addition of the inspection certificate number on it. In addition, PAC Forms 7 and 7(c) will not be required from handlers wishing to be approved handlers of immature papayas. In the absence of mandatory inspection, no handlers will be required to apply for approval to handle immature papayas using PAC Form 7 nor report shipments of immature papayas to the committee using PAC Form 7(c). This rule will decrease the burden by 9.25 hours.

The Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

In addition, the committee's meetings were widely publicized throughout the papaya industry and all interested persons were encouraged to attend the meetings and participate in committee deliberations on all issues. Like all committee meetings, the December 28, 2000, and the subsequent January 11, 2001, meetings were public meetings and all entities, both large and small, were encouraged to express views on this issue. The committee itself is comprised of 13 members, consisting of nine producer members and three handlers members. The committee also includes a public member who does not represent an agricultural interest nor have a financial interest in papayas.

An interim final rule concerning this action was published in the Federal Register on May 30, 2001. Copies of the rule were mailed by the committee's staff to all committee members and papaya handlers. In addition, the rule was made available through the Internet by the Office of the Federal Register. That rule provided for a 60-day comment period which ended July 30, 2001. No comments were received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at the following website: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matters presented, including the information and recommendation submitted by the committee and other available information, it is found that finalizing the interim final rule, without change, as published in the Federal Register (66 FR 29216, May 30, 2001) will tend to effectuate the declared policy of the Act.

This final rule is issued under Marketing Agreement No. 125 and Order No. 966, both as amended (7 CFR part 966), regulating the handling of tomatoes grown in Florida, hereinafter referred to as the “order.” The marketing agreement and order are effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (Department) is issuing this rule in conformance with Executive Order 12866.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect. This rule will not preempt any State or local laws, regulations, or policies, unless they present an irreconcilable conflict with this rule.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with the Secretary a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing the Secretary would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review the Secretary's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This final rule removes the net weight exemption currently prescribed for producer field-packed tomatoes under the Florida tomato marketing order. The Committee recommended this change at its meeting on February 27, 2001, with a vote of eight in favor and two opposed.

Under the order, tomatoes produced in the production area and shipped to fresh market channels outside the regulated area are required to meet grade, size, inspection, and container requirements. These requirements apply during the period October 10 through June 15 each year. Current requirements include a minimum grade of U.S. No. 2 and a minimum size of 29/32 inches in diameter. Current pack and container requirements outline the types of information that need to appear on a container, weight restrictions, and where the containers must be packed.

Section 966.52 of the Florida tomato marketing order provides authority for the issuance of regulations. This includes authority to establish and modify pack and container requirements for tomatoes grown in the defined production area and handled under the order.

Section 966.323 contains the handling regulations issued under the order. Section 966.323(a)(3)(i) requires that tomatoes packed by registered handlers be packed in containers of 10, 20, and 25 pounds designated net weights. The net weight of a container's contents cannot be less than the designated net weight or exceed the designated net weight by more than two pounds. Section 966.323(a)(3)(ii) requires that tomatoes be packed by registered handlers in containers that are marked with the designated net weight and with the name and address of the registered handler, and that such containers must be packed at the registered handler's facilities.

Section 966.323(d)(1) contains exemptions to the regulations. The section currently exempts producer field-packed tomatoes from the container net weight requirements and the requirement that each container or lid be marked to indicate the designated net weight. It also exempts producer field-packed tomatoes from the requirement that all containers must be packed at a registered handler's facilities. However, field-packed tomatoes still must meet the other requirements of the marketing order, including established grade, size, container, pack, and inspection requirements.

This rule removes the net weight and weight labeling exemptions for producer field-packed tomatoes. This change requires all tomatoes, unless specifically granted an exemption, to meet the same net weight requirements regardless of where they are packed.

Producer field-packed tomatoes are tomatoes which at the time of inspection are No. 3 color or higher (according to color classification requirements in the U.S. tomato standards), that are picked and place packed in new containers in the field by a producer as defined in § 966.150 of the rules and regulations. The tomatoes are then transported to a registered handler's facilities for final preparation for market and for inspection.

Producer field-packed tomatoes are picked by hand and place packed in containers in layers. When place packing a container of tomatoes, the fill is determined by the size of the tomato, dimensions of the container, and the way the tomatoes are positioned in the box. Each layer is tightly packed by rotating the tomatoes and by the size selection of the tomatoes. Each 25-pound container usually has three to four layers of tomatoes.

Most tomatoes from Florida are packed and shipped at the mature green stage. Shipments of mature green tomatoes represented approximately 83.7 percent of total fresh shipments during the 1999-2000 season. Tomatoes are picked and packed at the mature green stage to facilitate handling. The vast majority of mature green tomatoes are packed using a mechanized process. The tomatoes are brought to the packinghouse where they are run across sizing equipment, and then are packed in volume fill containers by size and weight. At the mature green stage, the tomatoes are firm and are able to withstand the packing process. This is an efficient process that facilitates packing in volume.

However, when packing a producer field-packed tomato that is more ripe and mature, the process used to pack mature greens is not as effective. This is because as the tomato begins to ripen it begins to soften. Tomatoes of No. 3 color and above cannot tolerate the rigors of the mechanized handling process. This packing process bruises and damages more mature tomatoes, increasing the volume of culls and tomatoes that fail inspection.

When the net weight exemption for producer field-packed tomatoes was established October 10, 1998 (63 FR 54556), the Committee thought that meeting the net weight requirement would be difficult without the precision of the mechanical process available at the packinghouse. Therefore, the Committee recommended establishing the net weight exemption to facilitate the packing of field-packed tomatoes. However, after several years of experience, those packing producer field-packed tomatoes have enhanced their skill for packing tomatoes in the field. Many now pack to meet the net weight requirement even though the exemption is available.

Field-packed tomatoes are sized as either 5X6 or 6X6 and larger with no upper limit on either size. This differs from the size requirements for tomatoes packed at a packinghouse. Packinghouse tomatoes must meet a minimum and a maximum size requirement on tomatoes designated at 6X6. Because there is no upper limit on either the 5X6 or 6X6 sized field-packed tomatoes, handlers have more flexibility to add and remove tomatoes of different sizes in order to meet a specified weight requirement without compromising their ability to meet the size requirement. Handlers can replace larger tomatoes with smaller ones and vice versa in order to adjust box weight to meet the net weight requirements. In its discussion, the Committee stated that most handlers of producer field-packed tomatoes are voluntarily meeting the 25-pound net weight requirements.

It also found that some handlers have started using the net weight exemption as a marketing tool. The Committee stated that producer field-packed tomatoes packed in containers designed to hold a 25-pound designated net weight were being presented for sale with weights of 28 to 32 pounds. The net weight requirement only allows packinghouses to put between 25 and 27 pounds of tomatoes to a box. Some handlers of producer field-packed tomatoes are adding additional tomatoes to the containers to create a marketing advantage over those handlers required to meet the net weight requirements. Buyers prefer the additional weight in containers of field-packed tomatoes to packinghouse tomatoes because they are getting more tomatoes for their money.

In its discussions, Committee members stated that over packing containers is a poor marketing practice. Selling a container of tomatoes that weighs more than 25 pounds at the price for a 25-pound container has a price depressing effect on the market, and reduces returns to growers. It was also noted that the marketing order was put in place to create an orderly market for all tomatoes grown in Florida because the market at that time was in such disarray. The net weight was established to provide an industry standard and give buyers and sellers a uniform point of comparison. With the volume of producer field-packed tomatoes increasing, several Committee members stated that continuing with the net weight exemption for field-packed tomatoes was taking a step backwards in terms of orderly marketing.

In addition, there was also concern regarding the possibility that damaged tomatoes could reach the market. Committee members stated that when a 25-pound box of tomatoes is filled to exceed a 27-pound net weight, there is an increased chance that tomatoes will be crushed when placing the lid on the container. Overfilling could also result in fruit being damaged during shipment.

The market for red, vine-ripe tomatoes has grown over the past few years. The Committee now estimates that between five and fifteen percent of the total daily fresh tomato shipments from Florida are producer field-packed tomatoes. This is a one to two percent increase from last season. Retailers consider the fast growing market for red, vine-ripe tomatoes to be the way of the future and the Committee estimates that the volume of producer field-packed tomatoes will continue to grow in order to supply this market. Therefore, the Committee wants to continue to develop this market by providing a uniform, quality product.

To accomplish these goals, this rule removes the exemption from the net weight requirement for producer field-packed tomatoes, and requires producer field-packed tomatoes to meet the same net weight and weight labeling requirements as those packed in a packinghouse.

The two Committee members who opposed the recommendation agreed that a problem exists with the net weight exemption for producer field-packed tomatoes. However, they were not sure that the action recommended was the best solution to the problem and wanted more time to consider the issue. Therefore, they voted against the proposal.

Section 8e of the Act requires that whenever grade, size, quality, or maturity requirements are in effect for certain commodities under a domestic marketing order, including tomatoes, imports of that commodity must meet the same or comparable requirements. However, the Act does not authorize the imposition of pack and container requirements on imports, when such requirements are in effect under a domestic marketing order. Therefore, no change is necessary in the tomato import regulation as a result of this action.

This change will not affect the exemption for single layer and two-layer place packed tomatoes. They will continue to be exempt from the net weight requirements under the order. Therefore, producer field-packed tomatoes place packed in single or two layer packs will continue to be exempt from the net weight requirements.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 82 handlers of Florida tomatoes who are subject to regulation under the marketing order and approximately 100 tomato producers in the regulated area. Small agricultural service firms are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $5,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000. Since the proposed rule was published, the benchmark for small producers was increased from $500,000.

Based on the industry and Committee data, the average annual price for fresh Florida tomatoes during the 2000-01 season was $9.16 per 25-pound carton or equivalent, and total fresh shipments for the 2000-01 season were 53,649,508 25-pound equivalent cartons of tomatoes. Based on this information, the majority of handlers would be classified as small entities as defined by the SBA. The majority of producers of Florida tomatoes may also be classified as small entities.

This final rule revises the handling requirements currently prescribed for producer field-packed tomatoes under § 966.323 of the order. Currently, producer field-packed tomatoes are exempt from the net weight requirements under the order. The net weight requirement only allows packinghouses to put between 25 and 27 pounds of tomatoes into a box designed to hold 25 pounds. Some handlers of producer field-packed tomatoes are adding additional tomatoes to their containers to the detriment of handlers required to meet the net weight requirements. This rule removes the exemption from the net weight requirement for producer field-packed tomatoes and requires all tomatoes, regardless of where they are packed, to meet the same net weight requirements. Authority for this action is provided in § 966.52 of the order.

There could be some additional costs associated with this rule. Removing the net weight exemption will require those packing producer field-packed tomatoes to take the steps necessary to ensure that the tomatoes meet the net weight requirement. This could result in additional costs from the purchase of equipment to weigh the boxes and additional labor needed. However, many of those packing producer field-packed tomatoes have already incurred these costs and are meeting the net weight requirements voluntarily.

Currently, boxes containing between 28 and 32 pounds of field-packed tomatoes may be sold for the same price as a box containing 25 to 27 pounds of tomatoes. This reduces total pack out, depresses price, and reduces returns to the grower. In addition, these tomatoes are being sold into what retailers consider to be the fastest growing segment of the tomato market. Over packing boxes increases the probability that some tomatoes will be damaged. Shipping damaged tomatoes could have a negative impact on the market and the ability of Florida tomato handlers in meeting that market's needs. This rule will help counter that possibility.

This rule was recommended to benefit the Florida tomato industry. The costs or benefits of this rule will not be disproportionately greater or less for small handlers or producers than for larger entities.

The Committee discussed alternatives to this change, including making no change to the regulation. However, Committee members agreed that action needed to be taken, so this alternative was rejected. Another alternative considered was to change the size of the box for field-packed tomatoes. Some members of the Committee stated that this would not solve the problem, only add another box size, noting that handlers are already selling a 25-pound container of producer field-packed tomatoes that weighs more than 25 pounds. Changing only the size of the container would not prevent handlers from continuing to overfill the cartons. Therefore, this alternative was also rejected.

This final rule removes the exemption from the net weight requirement for producer field-packed tomatoes under the Florida tomato marketing order.

This final rule will not impose any additional reporting or recordkeeping requirements on either small or large tomato handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, the Department has not identified any relevant Federal rules that duplicate, overlap or conflict with this final rule.

Further, the Committee's meeting was widely publicized throughout the tomato industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the February 27, 2001, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

A proposed rule concerning this action was published in the Federal Register on August 2, 2001 (66 FR 40158). Copies of the rule were mailed or sent via facsimile to all Committee members and tomato handlers. Finally, the rule was made available through the Internet by the Office of the Federal Register and the Department. A 20-day comment period ending August 22, 2001, was provided to allow interested persons to respond to the proposal.

Two comments were received during the comment period in response to the proposal. The comments were from two industry groups in support of the proposed action. The points made in the comments reflected information included in the proposed rule and were thoroughly discussed prior to the Committee vote.

Accordingly, no changes will be made to the rule as proposed, based on the comments received.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/fv/moab.html. Any questions about the compliance guide should be sent to Jay Guerber at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant matter presented, including the information and recommendation submitted by the Committee, the comments received, and other available information, it is hereby found that this rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

It is further found that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register (5 U.S.C. 553) because the final rule needs to be effective by the start of the 2001-02 season, which begins October 10, 2001. Further, handlers are aware of this rule, which was recommended at a public meeting. Also, a 20-day comment period was provided for in the proposed rule, and two comments supporting the action were received.

On June 27, 2001, the FAA issued Emergency AD 2001-13-51 for BHTC Model 206L-4, 407, and 427 helicopters, which requires the following if driveshaft, part number 206-340-300-105, has ever been installed on a BHTC Model 407 helicopter:

• At specified hours time-in-service (TIS), visually inspect each driveshaft for a crack, a loose bolt or nut, or red powder residue.

• Before further flight, replace the driveshaft with an airworthy driveshaft if a crack, a loose bolt or nut, or red powder residue is found. Within 10 days, notify the Manager, Regulations Group, FAA, of the helicopter serial number, driveshaft serial number, and driveshaft hours TIS.

• After the effective date of this AD, interchanging a driveshaft between different helicopter models is prohibited if that driveshaft has ever been installed on a BHTC Model 407 helicopter.

Transport Canada, which is the airworthiness authority for Canada, notified the FAA that an unsafe condition may exist on BHTC Model 407 helicopters. Transport Canada advises that during flight the driveshaft, P/N 206-340-300-105, failed causing engine shutdown and a forced landing. Three other incidents of the cracked flexframe on the forward end of the BHTC Model 407 driveshafts were also reported. Pending further corrective action, Transport Canada determined that a one-time visual inspection for any obvious discrepancy of the driveshaft is warranted.

The FAA has reviewed BHTC Alert Service Bulletin No. 407-01-43, dated June 8, 2001 (ASB), which describes procedures for a one-time inspection of the engine-to-transmission driveshaft, P/N 206-340-300-105. Transport Canada classified this ASB as mandatory and issued AD CF-2001-24, dated June 11, 2001, to ensure the continued airworthiness of BHTC Model 407 helicopters in Canada.

Since the unsafe condition described is likely to exist or develop on other BHTC Model 206L-4, 407, and 427 helicopters of the same type designs, the FAA issued Emergency AD 2001-13-51 to prevent failure of a driveshaft, loss of drive to the main rotor system, and a subsequent emergency forced landing. The AD requires the actions specified above. The inspections must be accomplished in accordance with the ASB described previously. The short compliance time involved is required because the previously described critical unsafe condition can adversely affect the structural integrity and controllability of the helicopter. Therefore, visually inspecting the driveshaft at the specified time intervals and replacing the driveshaft, if necessary, is required before further flight, and this AD must be issued immediately.

Since it was found that immediate corrective action was required, notice and opportunity for prior public comment thereon were impracticable and contrary to the public interest, and good cause existed to make the AD effective immediately by individual letters issued on June 27, 2001 to all known U.S. owners and operators of BHTC Model 206L-4, 407, and 427 helicopters. These conditions still exist, and the AD is hereby published in the Federal Register as an amendment to 14 CFR 39.13 to make it effective to all persons. However, a few editorial changes have been made to the AD. The zip code listed for the manufacturer has been corrected and an e-mail address for obtaining service information has been added. Also, due to confusion expressed by an operator, paragraph (a)(1)(i) has been changed to clarify that the notification requirement is necessary only if a crack, a loose bolt or nut, or red powder residue is found during the visual inspection. The FAA has determined that these changes will neither increase the economic burden on an operator nor increase the scope of the AD

The FAA estimates that 488 helicopters of U.S. registry will be affected by this AD, that it will take approximately 4 work hours per helicopter to visually inspect the driveshaft. The average labor rate is $60 per work hour. Based on these figures, the total cost impact of the AD on U.S. operators is estimated to be $117,120, assuming that each driveshaft is inspected once.

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 in the Rules Docket for examination by interested persons. A report that summarizes each FAA-public contact concerned with the substance of this AD will be filed in the Rules Docket.

Commenters wishing the FAA to acknowledge receipt of their mailed comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. 2001-SW-29-AD.” The postcard will be date stamped and returned to the commenter.

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

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

The FAA has received several reports of corroded and/or broken barrel nuts on certain Boeing Model 767-200 and -300 series airplanes. One operator indicated that cracked and bulging sealant of two attachment barrel nuts of the vertical fin at body section 48 was found on an airplane having 9,795 total flight hours and 4,184 total flight cycles. A torque check confirmed low torque at these locations, and removal of the sealant revealed that both barrel nuts were corroded and broken. Further investigation revealed that the broken barrel nuts fractured due to stress corrosion cracks that started at corrosion pits. Examination of the attachment bolts showed inadequate sealant on the bolt threads and shank. The lack of sealant initiated galvanic corrosion between the H-11 steel barrel nut and the Inconel bolt, which created the corrosion pits. Nuts made of H-11 steel alloy are susceptible to stress corrosion cracking. Another operator reported cracked sealant and barrel nut corrosion on an airplane having 20,655 total flight hours and 4,768 total flight cycles. Of the sixteen barrel nuts removed from that airplane and inspected, several were found to be corroded.

A recent report was received of four cracked barrel nuts found on a Boeing Model 767-300 series airplane; three of those four were found on one side of the airplane. This report revealed that the issue was more urgent than initial reports indicated. Subsequently, another report was received from an operator of a Group 1 airplane(Group 1 airplanes were delivered with H-11 alloy steel bolts and nuts), indicating that a broken barrel nut was found and both the bolt and the barrel nut were H-11 alloy steel (no dissimilar metal). This report revealed that the unsafe condition also exists on Group 1 airplanes with H-11 alloy steel bolts installed.

Such conditions, if not corrected, could result in reduced structural integrity of the vertical fin attachment joint, loss of the vertical fin, and consequent loss of controllability of the airplane.

The FAA has reviewed and approved Boeing Service Bulletin 767-53-0085, dated May 14, 1998, and Boeing Alert Service Bulletin 767-53A0085, Revision 1, dated July 1, 1999. The service bulletins describe procedures for repetitive internal and external visual inspections to find discrepancies (i.e., cracked or damaged sealant, signs of corrosion damage, cracked or broken barrel nuts), of the barrel nuts that attach the vertical fin to body section 48, and follow-on actions. The follow-on actions include, but are not limited to, the following:

• Replacement of the barrel nut with a new Inconel barrel nut if any discrepancy is found at any barrel nut location.

• A torque check on each attachment bolt of the vertical fin if no discrepancy is found at any barrel nut location.

• Replacement of the barrel nut with a new Inconel barrel nut if a bolt can be turned during the torque check.

• Repeat of the internal and external visual inspections.

The service bulletins also provide an optional replacement of all 16 H-11 steel alloy barrel nuts of the vertical fin with Inconel barrel nuts, which would eliminate the need for the repetitive inspections.

Since an unsafe condition has been identified that is likely to exist or develop on other products of this same type design, the AD would require accomplishment of the actions specified in the service bulletin described previously, except as discussed below.

While the service bulletin specifies internal and external visual inspections to detect discrepancies of the sealant of the barrel nuts that attach the vertical fin to body section 48, this AD requires internal and external detailed visual inspections to detect discrepancies of the sealant. A note has been included in this AD to define that inspection.

Where the compliance time in the service bulletin specifies doing the internal and external visual inspections 1 year after receipt of the service bulletin, this AD requires those inspections be done within 45 days after the effective date of this AD. In developing an appropriate compliance time for this AD, the FAA considered not only the manufacturer's recommendation, but the degree of urgency associated with addressing the subject unsafe condition, the average utilization of the affected fleet, and the time necessary to perform the actions. In light of all of these factors, the FAA finds that the compliance time for completing the required inspections represents an appropriate interval of time allowable for affected airplanes to continue to operate without compromising safety.

Although the service bulletin specifies that no more work is necessary for Group 1 airplanes if the H-11 steel alloy attachment bolts of the vertical fin have not been replaced with Inconel bolts, this AD requires the inspections and follow-on actions for both Group 1 and Group 2 airplanes. This changes the applicability in the AD from that specified in the service bulletin, which was divided into two groups, one having line numbers 1 through 154 inclusive, and the other having line numbers 155 through 574 inclusive; to specify line numbers 1 through 574 inclusive.

Figure 5 of the Accomplishment Instructions of the service bulletin specifies that a bolt can be reinstalled if no corrosion, cracks, thread damage, or shank damage is found. However, for Group 1 airplanes with H-11 steel alloy bolts, this AD requires replacement of an H-11 steel alloy bolt with an Inconel bolt, if an Inconel barrel nut is installed at that location.

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

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

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

Submit comments using the following format:

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

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

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

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

Commenters wishing the FAA to acknowledge receipt of their comments submitted in response to this rule must submit a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket Number 2000-NM-385-AD.” The postcard will be date stamped and returned to the commenter.

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

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

The Titusville, Space Center Executive Airport, FL, was renamed the Titusville, Space Coast Regional Airport on September 5, 1996. As a result, the Class D airspace legal description must be amended. This rule will become effective on the date specified in the DATES section. Since this action has no impact on users of the airspace in the vicinity of the Titusville, Space Coast Regional Airport, Titusville, FL, notice and public procedure under 5 U.S.C. 553(b) are unnecessary. Class D airspace designations for airspace areas extending upward from the surface of the earth are published in paragraph 5000 of FAA Order 7400.9H, dated September 1, 2000, and effective September 16, 2000, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designations listed in this document will be published subsequently in the Order.

This amendment to Part 71 of the Federal Aviation Regulations (14 CFR part 71) amends Class D airspace at Titusville, FL.

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. It, therefore, (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 will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, and 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. Some SIAP amendments may have been previously issued by the FAA in a National Flight Data Center (NFDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP amendments may require making them effective in less than 30 days. For the remaining SIAPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

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. It, therefore—(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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs). The complete regulatory description on each SIAP is contained in the appropriate FAA Form 8260 and the National Flight Data Center (FDC)/Permanent (P) Notices to Airmen (NOTAM) which are incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of the Federal Aviation's Regulations (FAR). Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction of charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR (and FAR) sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) established, amends, suspends, or revokes SIAPs. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained in the content of the following FDC/P NOTAMs for each SIAP. The SIAP information in some previously designated FDC/Temporary (FDC/T) NOTAMs is of such duration as to be permanent. With conversion to FDC/P NOTAMs; the respective FDC/T NOTAMs have been canceled.

The FDC/P NOTAMs for the SIAPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs by FDC/P NOTAMs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a National Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.

Further, the SIAPs contained in this amendment are based on the criteria contained in the TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.

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. It, therefore—(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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

This amendment to part 97 of the Federal Aviation Regulations (14 CFR part 97) establishes, amends, suspends, or revokes SIAP's. The complete regulatory description of each SIAP is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 14 CFR 97.20 of the Federal Aviation Regulations (FAR). The applicable FAA Forms are identified as FAA Form 8260-5. Materials incorporated by reference are available for examination or purchase as stated above.

The large number of SIAP's, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number.

This amendment to part 97 is effective upon publication of each separate SIAP as contained in the transmittal. The SIAP's contained in this amendment are based on the criteria contained in the United States Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs, the TERPs criteria were applied to the conditions existing or anticipated at the affected airports.

The FAA has determined through testing that current non-localizer type, non-precision instrument approaches developed using the TERPS criteria can be flown by aircraft equipped with a Global Positioning System (GPS) and or Flight Management System (FMS) equipment. In considering of the above, the applicable SIAP's will be altered to include “or GPS or FMS” in the title without otherwise reviewing or modifying the procedure. (Once a stand alone GPS or FMS procedure is developed, the procedure title will be altered to remove “or GPS or FMS” from these non-localizer, non-precision instrument approach procedure titles.)

The FAA has determined through extensive analysis that current SIAP's intended for use by Area Navigation (RNAV) equipped aircraft can be flown by aircraft utilizing various other types of navigational equipment. In consideration of the above, those SIAP's currently designated as “RNAV” will be redesignated as “VOR/DME RNAV” without otherwise reviewing or modifying the SIAP's.

Because of the close and immediate relationship between these SIAP's and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are, impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.

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. It, therefore—(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 anticipate impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Antidumping duties are imposed upon imported merchandise that the U.S. Department of Commerce has found is, or is likely to be, sold in the United States at less than its fair value. Countervailing duties are imposed upon imported merchandise that the Department of Commerce determines benefits from actionable subsidies bestowed by a foreign government. In all antidumping cases, and in most countervailing duty cases, these duties are only assessed if the U.S. International Trade Commission determines that the imported goods cause material injury or the threat of material injury to a domestic industry. The rules and procedures concerning proceedings leading to orders or findings under which antidumping and countervailing duties are assessed are found in 19 U.S.C. 1671 et seq., in part 207 of the regulations of the U.S. International Trade Commission (19 CFR chapter II, part 207), and in part 351 of the regulations of the International Trade Administration, U.S. Department of Commerce (19 CFR chapter III, part 351).

The Continued Dumping and Subsidy Offset Act of 2000 (“CDSOA”) was enacted on October 28, 2000, as part of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2001 (“Act”) (Pub. L. 106-387; 114 Stat. 1549). The provisions of the CDSOA are contained in Title X (sections 1001-1003) of the Act.

The CDSOA, in section 1003 of the Act, amended Title VII of the Tariff Act of 1930, by adding a new section 754 (codified at 19 U.S.C. 1675c) in order to provide that assessed duties received pursuant to a countervailing duty order, an antidumping duty order, or an antidumping duty finding under the Antidumping Act of 1921, would be distributed by Customs to affected domestic producers for certain qualifying expenditures that these producers incur after the issuance of such an antidumping duty order or finding, or countervailing duty order. This distribution is called the continued dumping and subsidy offset. It is noted that the continued dumping and subsidy offset under 19 U.S.C. 1675c covers all antidumping and countervailing duty assessments made on or after October 1, 2000, in connection with all antidumping duty orders or findings, or countervailing duty orders, in effect as of January 1, 1999, or issued thereafter. Pursuant to 19 U.S.C. 1675c, the Commissioner of Customs shall prescribe procedures for distribution of the continued dumping and subsidy offset.

Accordingly, by a document published in the Federal Register (66 FR 33920) on June 26, 2001, Customs proposed to amend the Customs Regulations to add a new subpart F to part 159 (19 CFR part 159, subpart F; §§ 159.61-159.64) that principally prescribed the procedures, including the time and manner, and the required information necessary for the distribution of antidumping and countervailing duties assessed under an appropriate order or finding, that would be payable as a continued dumping and subsidy offset to those affected domestic producers for their qualifying expenditures, in accordance with section 754 of the Tariff Act of 1930, as amended (19 U.S.C. 1675c).

In addition, under the Background heading of the proposed rule document (66 FR at 33922-33923), Customs provided several illustrations of the administrative process by which Customs would make distributions of the continued dumping and subsidy offset to affected domestic producers.

The June 26, 2001, notice of proposed rulemaking made provision for the submission of public comments on the proposed regulations for consideration before adoption of those regulations as a final rule. The prescribed comment period closed on July 26, 2001. Forty comments were received by Customs. The issues raised in the comments are summarized and addressed below.

Comment: Several commenters requested that Customs clarify the term “producer”. It was asked in this context whether companies that have filed for bankruptcy could still be affected domestic producers for purposes of the statute.

Customs Response: Customs agrees. Companies that have filed for bankruptcy would be affected domestic producers for purposes of section 1675c, if they remained in operation and continued to produce the product covered by the relevant order or finding, and provided further that such companies complied with the other requirements of the statute.

In addition, companies will be considered to have ceased production if they did not produce the product covered by an order or finding at all during the fiscal year that is the subject of the disbursement. This latter requirement is added in § 159.61(b)(1) which is redesignated as § 159.61(b)(2)(i) in this final rule document.

Comment: Several commenters proposed that domestic parties not on the list of affected domestic producers, as prepared by the U.S. International Trade Commission (USITC), be allowed to file certifications to claim an offset. Also, many comments included a request that the proposed regulations be clarified to provide for the filing of certifications by successor companies to those companies that appeared on the USITC list.

Customs Response: Under the 19 U.S.C. 1675c(d)(1), and as indicated in § 159.61(b), only a party on the USITC list is potentially eligible to receive an offset as an affected domestic producer. However, Customs agrees that a provision must be made for successor companies, as discussed below.

Specifically, where a company has succeeded to the operations of another company that appeared on the USITC list of affected domestic producers, the successor company may file a certification on behalf of the predecessor company. The USITC list is contained in the notice of intention to distribute the continued dumping and subsidy offset that must be published in the Federal Register in accordance with § 159.62. In its certification, the company must name the predecessor company to which it has succeeded and it must describe in detail the duly authorized succession by which it is entitled to file the certification on behalf of the predecessor.

A new paragraph (b)(1)(i) is added to § 159.61 in the final rule to address the filing of certifications by successor companies. As already noted, paragraph (b)(1) of proposed § 159.61 is redesignated as paragraph (b)(2)(i) in the final rule.

Comment: A number of commenters inquired as to whether an association whose name appeared on the USITC list for an order or finding could file a certification on behalf of its member companies and, if so, what qualifying expenditures could be included in the certification. It was also asked whether a company that was a member of such an association could file a certification, where the member company did not appear on the USITC list.

Customs Response: An association that appears on the USITC list of affected domestic producers in connection with a given order or finding, as set forth in the notice of distribution published in the Federal Register under § 159.62, cannot file a certification on behalf of its member companies. Customs does not believe that an association can properly certify, and thus be held liable for the accuracy of, member companies' qualifying expenditures. In order to certify, one must have direct knowledge of the validity of the expenses being claimed. In Customs view, associations are in no position to do so. The association may, of course, file a certification in its own right to claim an offset for that order or finding, but its qualifying expenditures would naturally be limited to those expenditures that the association itself has incurred in connection with that particular case, after the date of the order or finding.

In addition, an individual member of the association may file a certification to claim an offset for the same order or finding, even though the member company does not appear on the USITC list, provided that the company also meets the other requirements of the statute. It was clearly not the intent of Congress to prevent members of an association that initiated a proceeding at the USITC from filing certifications so that they may qualify for an offset under the statute, since an affected domestic producer is defined as “any manufacturer, producer, farmer, rancher, or worker representative (including associations of such persons)”.

In its certification, the company must name the association appearing on the USITC list, of which it is a member, and the company must specifically establish that it was a member of the association at the time the association filed the petition with the USITC.

To allow for the filing of certifications by an association's member companies that are not included on the USITC list of affected domestic producers, a new paragraph (b)(1)(ii) is added to § 159.61. Paragraph (b)(2) of proposed § 159.61 is redesignated as paragraph (b)(2)(ii) in the final rule.

Comment: A number of commenters suggested that Customs consult with the USITC on any questions that arise concerning the USITC list of affected domestic producers that appears in the Customs notice of intention to distribute the offset.

Customs Response: Customs already consults with the USITC in this matter and will continue to do so.

Comment: Some commenters suggested that Customs remove questionable parties from the list of affected domestic producers that is forwarded to Customs by the USITC, for example companies which do not appear to meet the domestic production criteria for filing a certification.

Customs Response: Customs will not arbitrarily delete parties from the list of companies supplied by the USITC. If a certification is submitted by a company appearing on the USITC list that third parties believe contains false statements regarding eligibility to file a certification and receive an offset, they may notify the Customs Office of Investigations regarding their allegations.

Comment: A number of commenters requested clarification of the term “qualifying expenditures”. These commenters basically wanted to know the end of the time period within which qualifying expenditures could be incurred for purposes of claiming an offset. For example, if an order was terminated in January 2000, could qualifying expenditures be claimed if they are incurred up until the date the first certification is filed (October 2001), or are the expenditures incurred limited by the date of the termination?

Customs Response: A qualifying expenditure that may be offset by a distribution of assessed antidumping and countervailing duties encompasses those expenditures that are incurred after the issuance of an order or finding and prior to the termination of the order or finding. Proposed § 159.61(c) is revised in the final rule to reflect this.

Customs expects that claims made for qualifying expenditures will be made in accordance with the statute and that they will be supported by records that would be kept by any prudent person in the ordinary course of business, as required in § 159.63(b) and (c). The record of expenditures being certified should conform to Generally Accepted Accounting Principles in determining when a qualifying expenditure has occurred. To the extent that common problem areas are found during Customs verifications of certifications, Customs will report on such issues in its annual report.

Comment: Several commenters suggested that Customs require companies claiming a distribution of the offset under an order or finding to limit their claims only to those qualifying expenditures that are associated with the product that is the subject of the order or finding.

Customs Response: Customs agrees. The statute (19 U.S.C. 1675c(b)(1)(B)) mandates that an affected domestic producer produce the product that is covered by an order or finding under which the offset is sought. Accordingly, there is a corresponding statutory limitation upon those qualifying expenditures that may lawfully be claimed as an offset under the order or finding. Consequently, qualifying expenditures on which a distribution may be claimed under section 1675c(b)(4) are limited only to those expenditures that can be related to the production of the product that is covered by the scope of the order or finding.

It is Customs position that any other interpretation would only result in absurd consequences. The lack of a like product limitation would discriminate against producers who do not manufacture multiple, disparate products, such as steel and petroleum products. Those producers who make multiple products would be able to claim all their expenditures on facilities and equipment, even if those expenses had little or no connection with the manufacture of the particular product involved in an order or finding. This would potentially reduce funds available for non-diversified producers. There would also be a substantial administrative problem for Customs if there were orders or findings on more than one product in a company's line of merchandise.

In this latter regard, one example would be an affected domestic producer who manufactures five different products, each of which is the subject of a separate antidumping/countervailing duty order or finding, and who incurs $1 million in qualifying expenditures. Of the $1 million in qualifying expenditures, $600,000 is related to the production of just one product, and $100,000 incurred during the production of each of the other four products. In the absence of a same product requirement, the affected domestic producer could simply claim $1 million for each certification. However, Customs would not be able to match the $1 million in claimed expenses with any one of the five special accounts and would therefore have no reasonable basis for apportioning distributions from those accounts.

Proposed §§ 159.61(c) and 159.63(d) are amended in the final rule to reflect this additional limitation upon qualifying expenditures.

Comment: Several commenters proposed that Customs make information available concerning the dollar amounts in the special accounts for an order or finding prior to requiring companies to file certifications.

Customs Response: Customs agrees. In future notices of intention to distribute the offset under § 159.62 for a given fiscal year, Customs will publish the dollar amount in the special account for each order or finding as of June 1 of that fiscal year. Of course, the final amount to be disbursed will differ, but the published amount may serve as an estimate for purposes of determining whether to file a certification for that fiscal year. Proposed § 159.62(b) is changed in the final rule to provide for this.

Comment: Several commenters proposed changing the signing official for the certifications to a lower-level employee, rather than a party legally authorized to bind the affected domestic producer, as required in proposed § 159.63(b).

Customs Response: Customs disagrees. The person signing the certification must be authorized to legally bind the domestic producer. Enforcement actions may be taken against individuals and companies who file false information with Customs.

Comment: One commenter requested that domestic producers be expressly permitted in proposed § 159.63(b)(2) to file claims for partial amounts.

Customs Response: Customs does not believe such a provision needs to be expressly set forth in the regulations. The important point is that any amounts certified by a claimant for distribution must be supported by business records that must be retained for possible Customs verification, as previously noted. If other qualifying expenditures become verified at a later date, those can be included in subsequent certifications to claim a distribution.

Comment: Several commenters requested clarification whether a company that is listed as an affected domestic producer on more than one order or finding may file a separate certification claiming a distribution, respectively, for each order or finding, using the same qualifying expenditures as the basis for distribution in each case. One commenter expressed a concern that Customs might overpay a claimant if a company may file multiple certifications in this way.

Customs Response: When the same product is covered by orders or findings for more than one country, an individual company that is listed for each of those cases must file the same dollar claim for each case, since qualifying expenditures are not associated with a specific country case. Consequently, in order to avoid the possibility of an overpayment in these circumstances, Customs will require each certification to list all other orders or findings where the company is claiming the same qualifying expenditures. This requirement is included in § 159.63(b)(3)(ii) in the final rule. However, as previously observed, those companies that have multiple orders on different products may not claim the same expenditures for all cases. The expenditures claimed must relate to the product covered by the order or finding for which an offset is being claimed.

Comment: Several commenters suggested that the certifications should require an additional statement specifying exactly how a party meets the requirements in the statute for filing a certification.

Customs Response: Customs disagrees. Proposed § 159.63(b)(3) already adequately addresses the requirements concerning those parties that would be entitled to file certifications.

It is also noted that, due to the addition of paragraphs (b)(3)(i) and (b)(3)(ii) to § 159.63 in the final rule, as indicated above, it has been decided, for editorial clarity, to reorganize paragraph (b)(3) of proposed § 159.63 in the final rule as paragraphs (b)(3), and (b)(3)(i)-(b)(3)(iii).

Comment: Many commenters suggested that Customs not reject certifications for minor errors or omissions. They also proposed a correction period for claimants to perfect their certifications.

Customs Response: Customs agrees. Parties listed in notices of intention to distribute must file their certifications within 60 days after publication of the notice, as already provided in proposed § 159.63(a). However, Customs will then have 15 days after the close of the 60-day filing period to return a certification that is found to be materially incorrect or incomplete. Within 10 days of the date that Customs returns a certification as being materially incorrect or incomplete, Customs must receive a corrected certification from the affected domestic producer. Customs will make every effort to assist companies to perfect their certifications and will not return claims for minor errors or omissions. Proposed § 159.63(c) is revised in the final rule to include these additional provisions regarding the processing of incorrect or incomplete certifications. Nevertheless, claimants should be mindful that it remains their responsibility to meet the requirements of the regulations for filing proper certifications.

Furthermore, in an effort to provide greater notice to domestic producers of Customs intent to distribute the offset, and thus enable the earlier filing of certifications, future notices of distribution will be published at least 90 days before the end of a fiscal year, as opposed to 60 days. Proposed § 159.62(a) is amended in the final rule to this effect.

Comment: One commenter suggested, with reference to proposed § 159.63(d), that Customs verify every certification. Another commenter recommended a 5-year retention requirement for records needed to support claims for distribution, rather than the 3-year period contained in proposed § 159.63(d).

Customs Response: A number of certifications may be selected to determine whether, and to what extent, verifications will be conducted.

However, Customs agrees with the recommendation for a 5-year record retention requirement, and proposed § 159.63(d) is changed in the final rule to provide for this. This accords with the general record retention provision of 5 years that is set forth in § 163.4(a), Customs Regulations (19 CFR 163.4(a)).

Comment: With respect to the information contained in the certifications described in proposed § 159.63, over 20 comments were received on the question of whether certain information required to be set forth in the certifications should be made public on a company-specific basis. The comments were equally divided over whether the company name and the dollar amounts claimed for an offset should be made public.

Customs Response: As stated in the proposed rule, Customs was especially interested in receiving public comment as to whether it should adopt the position that the name of the certifying producer and the total amount being certified for distribution should be considered information available for disclosure to the public.

Customs has concluded that the name of the claimant, the total dollar amount claimed by that party on the certification, as well as the total dollar amount that Customs actually disburses to that company as an offset, will be available for disclosure to the public. Customs has determined that this information does not qualify as business confidential information. Proposed § 159.63 is changed in the final rule by adding paragraph (e) to state that the submission of a certification by an affected domestic producer will be construed as an understanding on the part of the affected domestic producer that the foregoing information will be disclosed to the public. Alternatively, a statement in a certification that this information is proprietary and exempt from disclosure will result in Customs rejection of the certification.

Accordingly, as part of the annual report on the Continued Dumping and Subsidy Offset Act (CDSOA), Customs will publish the following by case number: the name of the claimant; the total dollar amount claimed by that party on the certification; and the total dollar amount disbursed to that company by Customs. Proposed § 159.64(g), which concerns the issuance of the annual report, is amended in the final rule to provide for this disclosure of information.

Comment: One commenter suggested that Customs prescribe how domestic producers may spend the disbursements that they receive under proposed § 159.64.

Customs Response: Customs disagrees. There is no statutory requirement as to how a disbursement to an affected domestic producer is to be spent, and, absent statutory authority, Customs may not impose such a requirement.

Comment: One commenter suggested that Customs deduct its administrative costs associated with the program from the offset to be distributed prior to making any disbursements.

Customs Response: Customs disagrees. There is no provision in the statute to allow for such a deduction.

Comment: Two commenters recommended that the disbursements to companies in an industry be reduced by the amount of other Government aid provided to that industry via other programs.

Customs Response: Customs disagrees. Again, there is no provision in the statute to allow for such a reduction. Thus, Customs has no authority to reduce the amount of the offset payable to affected domestic producers under the statute, based upon aid provided to such producers through other Government programs.

Comment: One commenter requested, in connection with proposed § 159.64(b), that a domestic producer furnish Customs with a surety bond in order to guarantee that any overpayment of assessed duties to the producer would be repaid in the event that a subsequent reliquidation results in a lesser amount of duties being assessed.

Customs Response: Customs disagrees. At this time, it does not appear to be practical or necessary to require domestic producers to file a surety bond to cover the amount of an annual distribution.

Comment: Two commenters expressed concern that administration of the CDSOA under proposed § 159.64(b)(2) would delay the processing of refunds to importers in the case of reliquidations and/or court action. The concern was that Customs would hold up action on a refund request until it had received repayment of the overpaid disbursement from the domestic producers.

Customs Response: Customs will not withhold action on refund claims based on the recovery of overpaid disbursements. Customs will establish procedures to compute the overpaid amounts to be recovered from domestic producers, so that recovery of the overpayment can be made, but those recoveries will take place independent of the refund of duties to importers. Customs already has authority under 19 U.S.C. 1520(a) to refund excess duties paid, and the necessary monies to make such refunds are authorized to be appropriated annually from the general fund of the Treasury.

Proposed § 159.64(b)(2) is revised in the final rule to include the assurance that refunds to importers will not be delayed pending the recovery of overpayments to domestic producers.

Comment: One commenter asserted that Customs had no authority to require repayment of an offset in proposed § 159.64(b)(3) when Customs had overpaid the offset due to an error in liquidation of an import entry.

Customs Response: The ability to recover potential overpayments of disbursed duties due to the reliquidation of import entries is a central feature of issuing disbursements. If Customs were unable to collect overpayments of disbursed duties due to import entry reliquidations, Customs would simply have to delay all disbursements until the time for reliquidation of the relevant import entries had passed, thereby precluding the possibility of overpayments due to reliquidations. Under this latter scenario, for example, disbursements for entries liquidated in Fiscal Year 2001 would not take place until November of 2002 if Customs did not have a mechanism in place to recover potential overpayments. With this mechanism in place, Customs anticipates completing distributions by the end of November 2001.

Comment: Many commenters stated that assessed duties remaining unclaimed after an annual distribution has occurred should not be deposited into the General Fund, as required under proposed § 159.64(c)(1), but should be available for future distributions to affected domestic producers.

Customs Response: Customs disagrees. In Customs view, sections 1675c(c) and (d)(3) of the statute clearly require disbursement of liquidated duties in each fiscal year, based on certifications timely filed for that year's assessments. There is no provision for disbursing duties collected in one fiscal year based on claims that may be filed two or three years later simply because there was a previous unclaimed balance. The CDSOA provides that “[s]uch distribution shall be made not later than 60 days after the first day of a fiscal year from duties assessed during the preceding fiscal year.” 19 U.S.C. 1675c(c).

However, the part of proposed § 159.64(c)(1) that dealt with the transfer of balances to different accounts has been deleted from this section in the final rule. Since that information only concerns internal Customs processing, it is not necessary to be included in the regulations.

Proposed § 159.64(c)(1) is changed in the final rule accordingly; and proposed § 159.64(b)(2) and (b)(3) is changed consistent with § 159.64(c)(1).

Comment: In cases where a distribution to an affected domestic producer was not for the entire amount certified, a number of commenters proposed that the time limit within which an affected domestic producer could request a reconsideration of the amount of the distribution be extended beyond the 10 business-day time limit set forth in proposed § 159.64(c)(3).

Customs Response: Customs agrees. Parties will have 30 calendar days, rather than 10 business days, to request reconsideration of a disbursement. Proposed § 159.64(c)(3) is revised in the final rule to include this requirement.

Comment: A number of commenters requested clarification of Customs actions when an order or finding has been terminated by the U.S. Department of Commerce (Commerce).

Customs Response: When an order or finding is terminated by the Department of Commerce, Customs will work with Commerce to determine the extent of unliquidated entries covered by the case. If, for example, there is more than one Commerce review period pending at the time of termination, and Commerce only issues liquidation instructions for one of the pending review periods, Customs will process the entries covered by the instructions as an annual disbursement. The delayed disbursement referred to in § 159.64(d)(2) is limited to the final distribution when the special account established under the order or finding is terminated.

Comment: Some commenters suggested, with reference to proposed § 159.64(e), that the Clearing Account and the Special Account that Customs establishes under the CDSOA should be interest-bearing accounts.

Customs Response: Customs disagrees. Briefly, as previously explained in the notice of proposed rulemaking, funds in Government accounts are not interest-bearing unless specified by Congress. Because Congress did not make an explicit provision for the accounts established under the CDSOA to be interest-bearing, no interest may accrue on these accounts. Thus, only interest charged on antidumping and countervailing duty funds themselves, pursuant to the express authority in 19 U.S.C. 1677g, will be transferred to the special accounts and be made available for distribution under the CDSOA.

Comment: A number of commenters wanted to know about the interest that Customs pays when antidumping or countervailing duty deposits exceed the final assessed duty amount. These commenters asked if this interest would have any effect on the amount of the offset for an order or finding.

Customs Response: Interest paid by Customs when deposits exceed the amount of the duties assessed will not be taken from either the clearing account or the special account. It is not a part of, and therefore does not reduce, the computation of the continued dumping and subsidy offset for an order or finding that would be distributed to affected domestic producers.

Comment: A number of commenters suggested that the annual report also contain the following general information for each order or finding: information regarding the number of entries and dollar amounts in the clearing account at the beginning of each fiscal year; the number and amount of Customs reliquidations during the fiscal year; and the dollar amounts remaining uncollected from Customs bills issued during the fiscal year.

Customs Response: Customs agrees that the annual report should include this information as well. Proposed § 159.64(g) is further revised in the final rule to make reference to the inclusion of this additional information in the annual report for public disclosure. Also, in its annual report, Customs will address any initiatives that have been implemented to improve the liquidation and disbursement process under the CDSOA.

Comment: Several commenters objected to the CDSOA as violating the World Trade Organization (WTO) agreements on Dumping and Subsidies and the North American Free Trade Agreement (NAFTA).

Customs Response: These comments concern the statute and not the regulations and, accordingly, fall outside the scope of this rulemaking.

Comment: One commenter requested a public hearing. Another commenter requested an extension of the period for filing comments.

Customs Response: Customs finds that the process of informal rulemaking in accordance with the Administrative Procedure Act (5 U.S.C. 553) conducted in this matter was sufficient. The comments received during the proposed rulemaking comment period fairly and adequately addressed the issues that were presented by the proposed rule, and Customs fully considered all views that were contained in the comments in issuing this final rule document. Neither a public hearing nor an extension of the comment period is necessary in this case.

Comment: Several commenters suggested the term “assessment” be defined.

Customs Response: Customs disagrees. As explained in the notice of proposed rulemaking, the assessment of duties on an import entry is accomplished by liquidating the subject entry; and, in pertinent part, the term “liquidation” is already defined in § 159.1, Customs Regulations (19 CFR 159.1), as the final computation or ascertainment of the duties accruing on an entry.

Comment: There were a few comments requesting a clarification of the pro rata allocation of the offset to affected domestic producers that is required under the statute (19 U.S.C. 1675c(d)(3)).

Customs Response: Customs believes that proposed § 159.64(c)(2), which addresses this issue, is clear and that no further clarification is necessary. Specifically, where the certified net claims exceed the offset available in a special account, the offset will be distributed on a pro rata basis based on each affected domestic producer's total certified claim. For example, on an individual case with only two claimants, if only $1 million is available for disbursement, where Company A claims total qualifying expenditures of $80 million, and Company B claims total qualifying expenditures of $20 million, Company A would receive $800,000 and Company B would receive $200,000. For those parties filing multiple certifications when there is more than one country case for a specific product, Customs will establish internal controls to prevent payments to affected domestic producers in excess of the amounts claimed.

Comment: One commenter suggested that the regulations specify that Customs decisions in administering the statute are subject to judicial review by the U.S. Court of International Trade (USCIT).

Customs Response: Customs disagrees. The CDSOA does not specify which particular federal court would have jurisdiction to review disputes regarding Customs decisions in administering the statute, and Customs lacks authority to confer jurisdiction on a particular court through its regulations.

Paragraph (b) of proposed § 159.63 is revised to include a requirement that the certification include a statement that the domestic producer has records to support the qualifying expenditures being claimed. Also, paragraph (b)(1)(vi) of proposed § 159.63, allowing for the distribution of an offset via Electronic Funds Transfer (EFT), is deleted since Customs has not made any provision for the electronic payment of the offset. Furthermore, proposed § 159.64(e) is revised in the final rule to reflect that statutory interest charged on antidumping and countervailing duties at liquidation will be transferred only to the special account for the related order or finding, when such interest is collected from the importer.

After careful consideration of the comments received and further review of the matter, Customs has concluded that the proposed amendments should be adopted with the modifications discussed above.

Customs finds that good cause exists under 5 U.S.C. 553(d)(3) for dispensing with a delayed effective date for this final rule. The final rule will instead be effective upon its date of publication in the Federal Register. Customs finds that it would be contrary to the public interest to delay distributions that affected domestic producers are entitled to under the statute. Moreover, dispensing with a delayed effective date is necessary in order to ensure that Customs is able to timely comply with the statutory requirement that assessed duties received in Fiscal Year 2001 be distributed to affected domestic producers by November 30, 2001 as provided in 19 U.S.C. 1675c(c).

The amendments implement the terms and conditions of the Continued Dumping and Subsidy Offset Act of 2000, which applies to antidumping and countervailing duties assessed on or after October 1, 2000. The amendments are necessary in order to enable and expedite the distribution of the offset to affected domestic producers. For these reasons, pursuant to the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 27a et seq.), it is certified that these amendments do not have a significant economic impact on a substantial number of small entities. Nor do the amendments meet the criteria for a “significant regulatory action” as specified in E.O. 12866.

The collection of information in this final rule document was submitted for review and has been approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) under OMB control number 1515-0229. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

This collection of information is contained in § 159.63. This information is necessary in order to enable, and to expedite, the distribution of the continued dumping and subsidy offset to the affected domestic producers. The likely respondents and/or recordkeepers are domestic business organizations, such as manufacturers, producers, ranchers, farmers and worker representatives (including associations of such persons). The estimated average annual burden associated with this information collection is 40 hours per respondent or recordkeeper.

Comments on the accuracy of this burden estimate and suggestions for reducing this burden should be sent to the Office of Management and Budget, Attention: Desk Officer for the Department of the Treasury, Office of Information and Regulatory Affairs, Washington, DC 20503. A copy should also be sent to the Regulations Branch, Office of Regulations and Rulings, U.S. Customs Service, 1300 Pennsylvania Avenue, NW., 3rd Floor, Washington, DC 20229.

Part 178, Customs Regulations (19 CFR part 178), containing the list of approved information collections, is revised to reflect the additional information collection burden imposed under this final rule.

The Department of the Treasury published a notice of a proposed rule exempting a system of records from certain provisions of the Privacy Act of 1974, as amended. The Internal Revenue Service (IRS) published the system notice in its entirety at 65 FR 63917-63918 (October 25, 2000), and the proposed rule in the same Federal Register on pages 63824-63826.

Under 5 U.S.C. 552a(k)(2), the head of an agency may promulgate rules to exempt any system of records within the agency from certain provisions of the Privacy Act of 1974, as amended, if the system is investigatory material compiled for law enforcement purposes. The Third Party Contact Reprisal Records-Treasury/IRS 00.334, contains investigatory material compiled for law enforcement purposes.

The proposed rule requested that public comments be sent to the Internal Revenue Service, Office of Governmental Liaison and Disclosure, 1111 Constitution Ave., NW., Washington, DC 20224, no later than November 24, 2000.

The IRS did not receive comments on the proposed rule. Accordingly, the Department of the Treasury is hereby giving notice that the system of records entitled “Third Party Contact Reprisal Records-Treasury/IRS 00.334,” is exempt from certain provisions of the Privacy Act. The provisions of the Privacy Act from which exemption is claimed pursuant to 5 U.S.C. 552a(k)(2) are as follows: 5 U.S.C. 552a (c)(3), (d)(1), (d)(2), (d)(3), (d)(4), (e)(1), (e)(4)(G), (H) and (I), and (f).

As required by Executive Order 12866, it has been determined that this proposed rule is not a significant regulatory action, and therefore, does not require a regulatory impact analysis.

The regulation will not have a substantial direct effect on the States, on the relationship between the Federal 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.

Pursuant to the requirements of the Regulatory Flexibility Act, 5 U.S.C. 601-612, it is hereby certified that these regulations will not significantly affect a substantial number of small entities. The final rule imposes no duties or obligations on small entities.

In accordance with the provisions of the Paperwork Reduction Act of 1995, the Department of the Treasury has determined that this final rule would not impose new record keeping, application, reporting, or other types of information collection requirements.

The SR 1 (Leeville) vertical lift span bridge across Bayou Lafourche, mile 13.3, at Leeville, Lafourche Parish, Louisiana, has a vertical clearance of 40 feet above mean high water in the closed-to-navigation position and 73 feet above mean high water in the open-to-navigation position. The containment equipment for the project will reduce the vertical clearance by two feet. Navigation on the waterway consists mainly of fishing vessels, recreation vessels and tugs with tows. LDOTD requested a temporary deviation from the normal operation of the drawbridge in order to accommodate the cleaning and painting of the bridge counterweight towers. This work is necessary for the continued safe operation of the bridge.

This deviation allows the draw of the SR 1 (Leeville) vertical lift span drawbridge across Bayou Lafourche, 13.3, to remain closed to navigation from 8 a.m. until 5 p.m. daily from Thursday, November 8, 2001 through Wednesday, December 5, 2001.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM. Publishing a NPRM was unnecessary and contrary to public interest since immediate action is needed to alleviate traffic congestion due to the advanced progress of the bridge replacement project.

The Maybank Highway Bridge across the Stono River mile 11.0 at Johns Island, Charleston County, SC, has a vertical clearance of 8 feet in the closed position at mean high water and a horizontal clearance of 55 feet between fenders. On November 6, 2000, the South Carolina Department of Transportation requested a modification from the current operating regulation in 33 CFR 117.5 which requires the drawbridge to open on signal.

Under this rule, the Maybank Highway Bridge shall open on signal: except that the draw need not open from 7 a.m. to 9 a.m. and from 4 p.m. to 6 p.m., Monday through Friday except Federal holidays. Between 9 a.m. and 4 p.m., Monday through Friday except Federal holidays, the draw need open only on the hour and half hour. The draw shall open as soon as possible for the passage of tugs with tows, public vessels of the United States and vessels in a situation where a delay would endanger life or property.

The John Limehouse Bridge, which is in close proximity to the Maybank Highway Bridge, is being replaced with a high-level fixed bridge. In addition, the Maybank Highway Bridge is also scheduled to be replaced. These two bridges are main access arteries onto and off of Johns Island, SC. This regulation will improve the transportation scheme for vehicular traffic during the construction of these bridge projects.

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).

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

This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to transit under the Maybank Highway Bridge from 7 a.m. until 6 p.m., Monday through Friday, except Federal holidays. 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 as the rule allows scheduled openings and all exempt vessels shall be passed at any time.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. Small entities may 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 of 1995 (44 U.S.C. 3501-3520).

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

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

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

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or 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 32(e) of Commandant Instruction M16475.1D, that this rule is categorically excluded from further environmental documentation.

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

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

The SR 1 (Leeville) vertical lift span bridge across Bayou Lafourche, mile 13.3, at Leeville, Lafourche Parish, Louisiana, has a vertical clearance of 40 feet above mean high water in the closed-to-navigation position and 73 feet above mean high water in the open-to-navigation position. The containment equipment for the project will reduce the vertical clearance by two feet. Navigation on the waterway consists mainly of fishing vessels, recreation vessels and tugs with tows. LDOTD requested a temporary deviation from the normal operation of the drawbridge in order to accommodate the cleaning and painting of the vertical lift span on the bridge. This work is necessary for the continued safe operation of the bridge. A separate deviation will be required in the future to accommodate the cleaning and painting of the tower counterweight sections of the bridge.

This deviation allows the draw of the SR 1 (Leeville) vertical lift span drawbridge across Bayou Lafourche, 13.3, to remain closed to navigation from 8 a.m. until noon and from 1 p.m. until 5:30 p.m. from Monday, September 24, 2001 through Saturday, November 3, 2001.

Highbridge Road Drawbridge, Atlantic Intracoastal Waterway, Volusia County, Florida, is a double leaf bridge with a vertical clearance of 15 feet above mean high water (MHW) measured at the fenders in the closed position and a horizontal clearance of 91 feet. The current operating regulation in 33 CFR 117.5 requires the draw to fully open on signal.

On July 17, 2001, the drawbridge owner requested a deviation from the current operating regulations to allow the owner to complete repairs.

The District Commander has granted a temporary deviation from the operating requirements listed in 33 CFR 117.5 to complete these repairs. Under this deviation, the Highbridge Road Drawbridge, shall open on single leaf from 8 a.m. on September 17, 2001 until 5 p.m. on September 30, 2001.

Section 301 of the Veterans Benefits and Health Care Improvement Act of 2000 (the Act), Pub. L. No. 106-419, amended 38 U.S.C. 101(24), which defines the term “active military, naval, or air service” to also include periods of inactive duty training during which individuals become disabled or die from an acute myocardial infarction, a cardiac arrest, or a cerebrovascular accident that occurred during such training. Section 301 also amended 38 U.S.C. 106(d) to provide that if a person was disabled or died as a result of any of these three diseases having occurred while the person was proceeding directly to or returning directly from a period of active duty for training or inactive duty training, such person would be deemed to have been on active duty for training or inactive duty training, as the case may be. We have amended paragraphs (a) and (e) of 38 CFR 3.6 to reflect the new statutory requirements.

Section 304 of the Act amended 38 U.S.C. 5503(b)(1), which sets forth a limitation on the payment of benefits to certain incompetent veterans who are hospitalized or institutionalized at government expense, who have neither spouse nor child, and who have estates with values that equal or exceed a specified amount. Under prior law, benefits were discontinued when the value of such veterans' estates equaled or exceeded $1,500; payments could not be resumed until the value of those estates had been reduced to $500. Under section 304 of the Act, effective November 1, 2000, benefits may not be discontinued until the estate of an affected incompetent veteran equals or exceeds an amount equal to five times the rate of compensation payable under 38 U.S.C. 1114(j) (the rate payable to a totally disabled veteran with no dependents). Under the new provision, benefit payments discontinued because of the estate limitation may not be resumed until the veteran's estate has been reduced to one-half the amount of the new estate limitation.

Because the rate of compensation payable under 38 U.S.C. 1114(j) is generally increased on an annual basis to keep pace with inflation, VA would have to make annual regulatory amendments to ten different regulations if we were to simply insert new dollar amounts where the regulations currently specify $1,500 and $500. This would be extremely burdensome on VA and would invariably result in regulations that specify incorrect dollar amounts until amendments to reflect increases in those amounts made their way through the regulatory process.

To prevent this result, VA has amended 38 CFR 3.557(b) to describe the method required by section 304 of the Act for calculating the dollar values for the estates of incompetent veterans which will trigger discontinuance or resumption of benefit payments. Each time there is an increase in the rate of compensation payable under 38 U.S.C. 1114(j), VA will calculate the new dollar values for discontinuance and resumption and will publish those dollar values in the Notices section of the Federal Register. The new values will be effective on the same day that the increase in the section 1114(j) rate becomes effective. In this way VA will be spared the burden of annually amending numerous regulations, and the public will have access to both the calculation method and the actual dollar value calculated using that method.

In § 3.557(b) we are also deleting the introductory phrase “Effective December 1, 1959,”. That phrase has no relevance to current claims processing.

In addition to § 3.557 there are several other regulations referring to the estate values that trigger discontinuance or resumption of benefits for certain incompetent veterans, either in their titles, text or cross-references. We have amended these regulations to remove references to specific dollar amounts. Where amounts appeared in the regulatory text, we have replaced them with references to the amounts calculated under § 3.557(b). Where specific amounts appeared in titles or cross-references we have amended them to eliminate reference to a dollar amount. The affected regulations are §§ 3.353, 3.452, 3.501, 3.558, 3.559, 3.1007, 13.70, 13.71 and 13.108.

Section 333 of the Act amended 38 U.S.C. 2303(b)(1), which governs eligibility for the plot or interment allowance when a veteran is buried in a cemetery, or a section of a cemetery, that is owned by a State or by an agency or a political subdivision of a State. The allowance was previously payable only if the cemetery, or section of the cemetery, was used solely for the interment of persons who were eligible for burial in a national cemetery. Section 333 expanded eligibility to include cemeteries, or sections of cemeteries, that are also used for the interment of persons who were members of a reserve component of the Armed Forces not otherwise eligible for burial in a national cemetery or who were former members of such a reserve component not otherwise eligible for burial in a national cemetery who were discharged or released from service under conditions other than dishonorable. We have amended § 3.1604(d)(1)(ii) to reflect these expanded eligibility criteria. These criteria apply only to the burial of persons dying on or after November 1, 2000.

Section 402(e) of the Act extended, until September 30, 2008, the expiration date for 38 U.S.C. 5503(f), which governs the amount of pension payable to certain veterans and surviving spouses receiving Medicaid-covered nursing home care. That provision was due to expire on September 30, 2002. We have amended § 3.551(i) to reflect the statutory change.

This final rule reflects statutory requirements. Accordingly, there is a basis for dispensing with the prior notice and comment and delayed effective date provisions of 5 U.S.C. 552 and 553.

This document contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501-3520).

This document has been reviewed by the Office of Management and Budget under Executive Order 12866.

Because no notice of proposed rulemaking was required in connection with the adoption of this final rule, no regulatory flexibility analysis is required under the Regulatory Flexibility Act (5 U.S.C. 601-612). Even so, the Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act. This final rule will not directly affect any small entities. Only VA beneficiaries are directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analyses requirement of sections 603 and 604.

Throughout this document, wherever “we,” “our,” or “us” is used, we mean EPA.

Conformity first appeared in the Act's 1977 amendments (Public Law 95-95). Although the Act did not define conformity, it stated that no Federal department could engage in, support in any way or provide financial assistance for, license or permit, or approve any activity which did not conform to a SIP which has been approved or promulgated.

The Act's 1990 Amendments expanded the scope and content of the conformity concept by defining conformity to an implementation plan. Section 176(c) of the Act defines conformity as conformity to an implementation plan's purpose of eliminating or reducing the severity and number of violations of the national ambient air quality standards (NAAQS) and achieving expeditious attainment of such standards. Also, the Act states that no Federal activity will: (1) Cause or contribute to any new violation of any standard in any area, (2) increase the frequency or severity of any existing violation of any standard in any area, or (3) delay timely attainment of any standard or any required interim emission reductions or other milestones in any area.

We were required to issue criteria and procedures for determining conformity of transportation plans, programs, and projects to a SIP by section 176(c) of the Act. The Act also required that each State submit a revision to its SIP including conformity criteria and procedures. We published the first transportation conformity rule in the November 24, 1993, Federal Register (FR), and it was codified at 40 CFR part 51, subpart T and 40 CFR part 93, subpart A. We originally required the States and local agencies to adopt and submit a transportation conformity SIP revision to us by November 25, 1994. However, we revised the transportation conformity rule on August 7, 1995 (60 FR 40098), November 14, 1995 (60 FR 57179), August 15, 1997 (62 FR 43780), and it was codified under 40 CFR part 51, subpart T and 40 CFR part 93, subpart A—Conformity to State or Federal Implementation Plans of Transportation Plans, Programs, and Projects Developed, Funded or Approved Under Title 23 U.S.C. or the Federal Transit Laws (62 FR 43780). Our action of August 15, 1997, required the States to change their rules and submit a SIP revision by August 15, 1998.

The Federal (or State) transportation conformity rule applies to all nonattainment and maintenance areas in a State. The Metropolitan Planning Organizations (MPOs), the State Departments of Transportation (in absence of a MPO), and U.S. Department of Transportation (USDOT) make conformity determinations. These agencies make conformity determinations on programs and plans such as transportation improvement programs, transportation plans, and projects. The MPOs calculate the projected emissions for the transportation plans and programs and compare those calculated emissions to the motor vehicle emissions ceiling established in the SIP. The calculated emissions must be smaller than the motor vehicle emissions ceiling (the “emissions budget”) for showing positive conformity with the SIP.

On November 5, 1999, the Governor of Colorado submitted a SIP revision that includes revisions to Colorado Regulation No. 10, Criteria for Analysis of Conformity, Part B—Conformity to State Implementation Plans of Transportation Plans, Programs and Projects Developed, Funded or Approved Under title 23 U.S.C. or the Federal Transit Act. The Colorado Air Quality Control Commission (AQCC) adopted this SIP revision on October 15, 1998 after appropriate public participation and interagency consultation.

On August 26, 1999, the Governor of Montana submitted a SIP revision that includes revisions to the Transportation Conformity section of its air quality rules (Sub-Chapter 13 of the Administrative Rules of Montana 9.2.2). The Montana Board of Environmental Review adopted this SIP revision on May 14, 1999 after appropriate public participation and interagency consultation. This SIP revision superseded an earlier version of the transportation conformity SIP that was adopted on August 8, 1996 and submitted on February 21, 1997.

We are approving the Colorado and Montana transportation conformity rules except for the incorporation by reference of 40 CFR Part 93, Subpart A, into Colorado Regulation No. 10. The rationale for this exclusion is discussed in Section II.D of this action. “Incorporation by Reference” (IBR) means that the State adopted the Federal rules without rewriting the text of the Federal rules but by referring to them for inclusion as if they were printed in the State regulation. EPA is not taking action on the States' IBR of the Federal rule for reasons discussed below. The effect of this action is that the States' consultation procedures will take the place of the general guidelines articulated in 40 CFR 93.105, and the remainder of the Federal rule will continue to apply for conformity purposes. Each State also adopted definitions that supplement, and in some cases, replace the definitions in § 93.101 of the Federal conformity rule. We are approving these definitions.

Our rule requires the States to develop their own processes and procedures for interagency consultation among the Federal, State, and local agencies and resolution of conflicts meeting the criteria in 40 CFR Part 93, § 93.105. The SIP revisions must include processes and procedures to be followed by the MPO, State DOT, and USDOT in consulting with the State and local air quality agencies and EPA before making conformity determinations. Also, the transportation conformity SIP revision must have processes and procedures for the State and local air quality agencies and EPA in coordinating development of applicable SIPs with MPOs, State DOT, and USDOT.

The States developed their own consultation rules based on the elements in 40 CFR 93.105. We have determined that each State adequately included all elements of 40 CFR 93.105 and met the EPA SIP requirements.

We promulgated the most recent transportation conformity rule on August 15, 1997. On March 2, 1999, the United States Court of Appeals for the District of Columbia Circuit issued its opinion in Environmental Defense Fund v. Environmental Protection Agency, No. 97-1637. The Court granted the environmental group's petition for review and ruled that 40 CFR 93.102(c)(1), 93.121(a)(1), and 93.124(b) are unlawful and remanded 40 CFR 93.118(e)(1) and 93.120(a)(2) to EPA for revision to harmonize these provisions with the requirements of the Act. The sections that were included in this decision were:

(1) 40 CFR 93.102(c)(1) which allowed certain projects for which the National Environmental Policy Act (NEPA) process has been completed by the DOT to proceed toward implementation without further conformity determinations during a conformity lapse,

(2) 40 CFR 93.118(e) which allowed use of motor vehicle emissions budgets (MVEB) in the submitted SIPs after 45 days if EPA had not declared them inadequate,

(3) 40 CFR 93.120(a)(2) which allowed use of the MVEB in a disapproved SIP for 120 days after disapproval,

(4) 40 CFR 93.121(a)(1) which allowed the nonfederally funded projects to be approved if included in the first three years of the most recently conforming transportation plan and transportation improvement programs, even if conformity status is currently lapsed, and

(5) 40 CFR 93.124(b) which allowed areas to use a submitted SIP that allocated portions of a safety margin to transportation activities for conformity purposes before EPA approval.

Since the States were required to submit transportation conformity SIPs not later than August 15, 1998, and include those provisions in verbatim form, Colorado's SIP revision includes all those sections which the Court ruled unlawful or remanded for consistency with the Act. Montana's transportation conformity SIP was adopted and submitted subsequent to the court's decision. Montana attempted to address the court decision by not submitting for IBR the sections of the Federal rule affected by the lawsuit. However, Montana's submittal is not consistent with EPA's most recent interpretations of the sections of the rule affected by the court decision.

Because the court decision has invalidated several sections of the rule, we believe that it would be reasonable to exclude the States' IBR of the rule from this SIP approval action. As a result, we are not taking any action on the IBR of 40 CFR Part 93, Subpart A into the State conformity rules. Conformity determinations should comply with the relevant requirements of the statutory provisions of the Act underlying the court's decision on these issues, and with the remaining sections of the Federal rule not affected by the court decision. (EPA issued guidance on May 14, 1999 on how to implement these provisions in the interim prior to EPA amendment of the Federal transportation conformity rules.) Once these Federal rules have been revised, agencies performing conformity determinations in Colorado and Montana should comply with the requirements of the revised Federal rule until corresponding provisions of the Colorado and Montana conformity SIPs have been amended and approved by EPA. Since EPA is not acting on the States' IBR of any sections of the Federal conformity rule, the Federal rule, along with EPA's guidance for implementing the court decision, will continue to apply for conformity determinations, with the exception of the consultation provisions of the State programs which we are approving today which will apply in lieu of the consultation provision of the Federal rule.

In this action, we are approving revisions to the Colorado and Montana transportation conformity SIPs. These SIP revisions were submitted by the Governor of Colorado on November 5, 1999 and by the Governor of Montana on August 26, 1999. We are publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no adverse comments. However, in the “Proposed Rules” section of today's Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revisions if adverse comments are filed. This rule will be effective on November 20, 2001 without further notice unless we receive adverse comments by October 22, 2001. If we receive adverse comments, we will publish a timely withdrawal of the direct final rule, in the Federal Register, informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. If no such comments are received, the public is advised that this rule will be effective on November 20, 2001, and no further action will be taken on the proposed rule. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). This rule also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. section 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 the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. section 804(2). This rule will be effective November 20, 2001 unless EPA receives adverse written comments by October 22, 2001.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 20, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

We are approving the South Carolina State Plan, as submitted on September 19, 2000, for the control of air emissions from HMIWIs, except for those HMIWIs located in Indian Country. When EPA developed our New Source Performance Standard (NSPS) for HMIWIs, we also developed EG to control air emissions from older HMIWIs. (See 62 FR 48348-48391, September 15, 1997, 40 CFR part 60, subpart Ce (Emission Guidelines and Compliance Times for HMIWIs) and subpart Ec (Standards of Performance for HMIWIs for Which Construction is Commenced After June 20, 1996)). The South Carolina DHEC developed a State Plan, as required by sections 111(d) and 129 of the Clean Air Act (the Act), to adopt the EG into their body of regulations, and we are acting today to approve it.

A HMIWI State Plan is a plan to control air pollutant emissions from existing incinerators which burn hospital waste or medical/infectious waste. The plan also includes source and emission inventories of these incinerators in the State.

States are required under sections 111(d) and 129 of the Act to submit State Plans to control emissions from existing HMIWIs in the State. The State Plan requirement was triggered when EPA published the EG for HMIWIs under 40 CFR part 60, subpart Ce (see 62 FR 48348, September 15, 1997).

Under section 129 of the Act, EPA is required to promulgate EG for several types of existing solid waste incinerators. These EG establish the Maximum Achievable Control Technology (MACT) standards that States must adopt to comply with the Act. The HMIWI EG also establishes requirements for monitoring, operator training, permits, and a waste management plan that must be included in State Plans.

The intent of the State Plan requirement is to reduce several types of air pollutants associated with waste incineration.

The State Plan establishes control requirements which reduce the following emissions from HMIWIs: particulate matter; sulfur dioxide; hydrogen chloride; nitrogen oxides; carbon monoxide; lead; cadmium; mercury; and dioxin/furans. These pollutants can cause adverse effects to the public health and the environment. Dioxin, lead, and mercury bioaccumulate through the food web. Serious developmental and adult effects in humans, primarily damage to the nervous system, have been associated with exposures to mercury. Exposure to dioxin and furans can cause skin disorders, cancer, and reproductive effects such as endometriosis. Dioxin and furans can also affect the immune system. Acid gases affect the respiratory tract, as well as contribute to the acid rain that damages lakes and harms forests and buildings. Exposure to particulate matter has been linked with adverse health effects, including aggravation of existing respiratory and cardiovascular disease and increased risk of premature death. Nitrogen oxide emissions contribute to the formation of ground level ozone, which is associated with a number of adverse health and environmental effects.

The criteria for approving a HMIWI State Plan include requirements from sections 111(d) and 129 of the Act and 40 CFR part 60, subpart B. Under the requirements of sections 111(d) and 129 of the Act, a State Plan must be at least as protective as the EG regarding applicability, emission limits, compliance schedules, performance testing, monitoring and inspections, operator training and certification, waste management plans, and recordkeeping and reporting. Under section 129(e), State Plans must ensure that affected HMIWI facilities submit Title V permit applications to the State by September 15, 2000. Under the requirements of 40 CFR part 60, subpart B, the criteria for an approvable section 111(d) plan include demonstration of legal authority, enforceable mechanisms, public participation documentation, source and emission inventories, and a State progress report commitment.

The South Carolina DHEC adopted the Federal EG and NSPS into Chapter 61 of the South Carolina Code, Regulation No. 61-62.5, Standard Number 3.1, “Hospital/Medical/Infectious Waste Incinerators.” The State rules were effective on May 26, 2000. The South Carolina State Plan contains:

1. A demonstration of the State's legal authority to implement the section 111(d)/129 State Plan;

2. State rule, Standard Number 3.1, as the enforceable mechanism;

3. An inventory of approximately 4 known designated facilities, along with estimates of their potential air emissions;

4. Emission limits that are as protective as the EG;

5. A compliance date of May 26, 2001;

6. Testing, monitoring, reporting and recordkeeping requirements for the designated facilities;

7. Records from the public hearing on the State Plan; and,

8. Provisions for progress reports to EPA.

The EG for existing HMIWIs affect any HMIWI built on or before June 20, 1996. If your facility meets this criterion, you are subject to these regulations.

You must meet the requirements listed in South Carolina Regulation No. 61-62.5, Standard Number 3.1, summarized as follows:

1. Determine the size of your incinerator by establishing its maximum design capacity.

2. Each size category of HMIWI has certain emission limits established which your incinerator must meet. See Table I of section III (Emission Limitations) of Standard Number 3.1, to determine the specific emission limits which apply to you. The emission limits apply at all times, except during startup, shutdown, or malfunctions, provided that no waste has been charged during these events.

3. There are provisions to address small rural incinerators (if your unit is applicable).

4. You must meet a 10% opacity limit on your discharge, averaged over a six-minute block.

5. You must have a qualified HMIWI operator available to supervise the operation of your incinerator. This operator must be trained and qualified through a State-approved program, or a training program that meets the requirements listed under Section IX (Operator Training and Qualification Requirements) of Standard Number 3.1.

6. Your operator must be certified, as discussed in 5 above, no later than May 26, 2001.

7. You must develop and submit to South Carolina DHEC a waste management plan. This plan must be developed under guidance provided by the American Hospital Association publication, An Ounce of Prevention: Waste Reduction Strategies for Health Care Facilities, 1993, and must be submitted to South Carolina DHEC no later than 60 days following the initial performance test for the affected unit.

8. You must conduct an initial performance test to determine your incinerators compliance with these emission limits. This performance test must be completed no later than May 26, 2001, and as required under 40 CFR 60.37e and Section IV (Performance Specifications) of Standard Number 3.1.

9. You must install and maintain devices to monitor the parameters listed under Table IV of Section V (Monitoring Requirements) of Standard 3.1.

10. You must document and maintain information concerning pollutant concentrations, opacity measurements, charge rates, and other operational data. This information must be maintained for a period of five years.

11. You must submit an annual report to South Carolina DHEC containing records of annual equipment inspections, any required maintenance, and unscheduled repairs. This annual report must be signed by the facilities manager.

A total of one comment letter was received during the public comment period for the proposed Plan approval, which ended on June 6, 2001. The issues are summarized below and addressed in a comment and response document contained in the docket:

(1) The commenter questioned why South Carolina Regulation No. 61-62.5, Standard Number 3.1, Section VII, subparagraph (c)(8) contained the requirements of § 60.56c(i) for the approval of site-specific operating parameters to be established during the initial performance test and continuously monitored thereafter. Section 129 of the Act requires section 111(d)/129 State plans to be “at least as protective as the guidelines.” In accordance with the section 111(d), section 129, subpart B, and subpart Ce requirements, the South Carolina regulation, specifically subparagraph (c)(8), includes the § 60.56c(i) requirements, in order for the State plan for South Carolina to be deemed an approvable section 111(d)/129 plan for implementing the emission guidelines for HMIWI.

(2) The commenter questioned why South Carolina Regulation No. 61-62.5, Standard Number 3.1, Section VII, subparagraph (a)(1) requires HMIWI facilities constructed before June 20, 1996, to perform a source test no later than 12 months following the effective date of the State standard. Section 60.24(g) of subpart B allows any State to adopt or enforce “compliance schedules requiring final compliance at earlier times than those specified in subpart C or in applicable guideline documents.” In accordance with the subpart B requirements, the South Carolina regulation, specifically subparagraph (a)(1), includes a compliance schedule earlier than specified in subpart Ce.

(3) These comments raise no specific issues or arguments affecting approval of the South Carolina section 111(d)/129 plan.

EPA compared the South Carolina rules (Chapter 61 of the South Carolina Code, Regulation No. 61-62.5, Standard Number 3.1) against our HMIWI EG. EPA finds the South Carolina rules to be at least as protective as the EG. The South Carolina State Plan was reviewed for approval against the following criteria: 40 CFR 60.23 through 60.26, Subpart B—Adoption and Submittal of State Plans for Designated Facilities; 40 CFR 60.30e through 60.39e, Subpart Ce—Emission Guidelines and Compliance Times for Hospital/Medical/Infectious Waste Incinerators; and, 40 CFR 62.14400 through 62.14495, Subpart HHH—Federal Plan Requirements for Hospital/Medical/Infectious Waste Incinerators Constructed on or before June 20, 1996. The South Carolina State Plan satisfies the requirements for an approvable section 111(d)/129 plan under subparts B and Ce of 40 CFR part 60 and subpart HHH of 40 CFR part 62. For these reasons, we are approving the South Carolina HMIWI State Plan.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This action merely approves state law as meeting Federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).

This rule also does not have tribal implications because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action merely approves a state rule implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because it is not economically significant.

In reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. In this context, in the absence of a prior existing requirement for the State to use voluntary consensus standards (VCS), EPA has no authority to disapprove a SIP submission for failure to use VCS. It would thus be inconsistent with applicable law for EPA, when it reviews a SIP submission, to use VCS in place of a SIP submission that otherwise satisfies the provisions of the Clean Air Act. Thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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 the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 20, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

The official record for this rulemaking, as well as the public version, has been established under Docket No. A-97-43 (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of electronic comments, that does not include any information claimed as confidential business information, is available for inspection from 8:00 a.m. to 4:00 p.m. Monday through Friday, excluding legal holidays. The official rulemaking record is located at the address in the ADDRESSES section. In addition, the Federal Register rulemaking actions under section 126 and the associated documents are located at http://www.epa.gov/ttn/rto/126.

EPA has issued a separate rule on NOX transport entitled, “Finding of Significant Contribution and Rulemaking for Certain States in the Ozone Transport Assessment Group Region for Purposes of Reducing Regional Transport of Ozone” (the NOX State implementation plan (NOX SIP) call). The rulemaking docket for that rule contains information and analyses that were relied on in the January 2000 final rule. In promulgating the January 2000 proposed rule, EPA incorporated by reference the entire NOX SIP call record. Documents related to the NOX SIP call are available for inspection in Docket No. A-96-56 at the address and times given above. In addition, certain documents associated with the NOX SIP call are located at http://www.epa.gov/ttn/oarpg/otagsip.html.

The information in this preamble is organized as follows:

In January 2000, EPA took final action under section 126 of the CAA on petitions filed by eight Northeastern States seeking to mitigate interstate transport of NOX.1 65 FR 2674 (January 18, 2000). Section 126 of the CAA authorizes a downwind State to petition EPA for a finding that an existing or new (or modified) major stationary source or a group of such sources emits or would emit in violation of section 110(a)(2)(D)(i) by contributing significantly to nonattainment of a National Ambient Air Quality Standard or interfering with maintenance of such a standard in a downwind State. EPA determined that certain EGUs and non-EGUs named in the petitions emit in violation of the CAA prohibitions against significantly contributing to nonattainment or maintenance problems in the petitioning States. The EGUs and non-EGUs covered by the January 2000 final rule are in the following States or portions of States and the District of Columbia: Delaware; Indiana; Kentucky; Maryland; Michigan; North Carolina; New Jersey; New York; Ohio; Pennsylvania; Virginia; and West Virginia. 65 FR 2675.

EPA established the Federal NOX Budget Trading Program as the control remedy for these sources. EPA determined allowable emissions for the sources and allocated NOX allowances to the sources. Under this program, an affected unit (referred to as a “ NOX Budget unit”) may buy or sell allowances but must hold, after the end of the ozone season, a number of allowances at least equal to the number of tons of NOX that the unit emitted during that ozone season.

For purposes of allocating allowances, EPA set for each State (or portion of State) NOX emission budgets (in tons of NOX per ozone season) for EGUs and non-EGUs. The EGU budget 1a for each State is the larger of the total ozone season heat input for EGUs in the State for 1995 or 1996, increased by a growth rate through 2007, and multiplied by a control level of 0.15 lb. NOX per mmBtu. The non-EGU budget 2 for each State is the non-EGU ozone season NOX emissions in the State for 1995, increased by a growth rate through 2007, at a 60 percent control level. EPA then allocated allowances to each existing unit, based on the unit's historical heat input. For EGUs, the average of the two highest ozone season heat inputs from 1995-1998 was used as the historical heat input. For non-EGU's, the 1995 ozone season heat input or, if data were available, the average of the two highest ozone season heat inputs from 1995-1998 was used as the historical heat input. 40 CFR 97.42(a). EPA also adjusted each unit's allocations so that the total number of allowances allocated to EGUs and the total number of allowances allocated to non-EGUs in a given State equaled 95 percent of the EGU budget and of the non-EGU budget respectively for that State. 40 CFR 97.42(b) and (c). Five percent of the budget was reserved for allocations to new units.

After EPA promulgated the January 2000 final rule, owners, or associations of owners, of EGUs or non-EGUs filed petitions with the D.C. Circuit challenging, among other things, the allowance allocations for certain units in the Federal NOX Budget Trading Program regulations. Subsequently, EPA entered into settlements with some of these owners and associations of owners. Today's action finalizes revised allowance allocations for these units, in a manner consistent with the settlements.

In addition, after promulgation of the January 2000 final rule, owners of non-EGUs submitted letters to EPA requesting correction of the allowance allocations for two other units under the rule. EPA responded that it was treating the letters as requests for reconsideration of the two units' allocations under the rule and would propose to revise the allocations. Today's action finalizes revised allocations for these units.

EPA is adopting specific, limited revisions to provisions of the Federal NOX Budget Trading Program rule, i.e., part 97, in order to change the NOX allowance allocations for certain NOX Budget units. In today's final rule, EPA is specifying which units will receive revised allocations, how EPA will obtain the additional allowances used for the revised allocations, and what will be the amount of each unit's revised allocation. As discussed below, EPA is revising the allocations for the units discussed in section II.A of today's preamble. To provide the revised allocations, EPA is using allowances that were allocated initially to units that EPA has subsequently determined are not NOX Budget units and therefore not subject to the Federal NOX Budget Trading Program. This approach to obtaining allowances for the revised allocations is discussed in section II.B. In section II.C, EPA discusses the amount of each unit's revised allocation.

The specific rule revisions necessary to implement the above-described approach are discussed in section II.D of today's preamble. EPA is revising Appendices A and B to part 97 in order to include revised allocations for the units identified in section II.A and remove allocations for some other units that EPA has previously determined not to be NOX Budget units.

EPA did not consider, or request comment on, any other changes to part 97 or the January 2000 final rule. The December 2000 proposed rule was limited to changes to part 97 that are necessary either: to correct the allocations for the units specifically identified here; or to provide the Administrator general authority to address similar allocation-quantity issues that may arise in the future.

In today's final rule, EPA is revising allocations for the following units:

1. A group of units referred to as “stranded” units: Unit 0B7, plant 00003, Union Carbide—South Charleston Plant, Kanawha County, West Virginia; and the Package Boiler at Weyerhaeuser Company Plymouth, plant 0069, Martin County and Power Boiler No. 2 at Weyerhaeuser Company New Bern Mill, plant 0104, Craven County in North Carolina;

2. SEI Birchwood, plant 12 (“Birchwood”);

3. A group of all West Virginia non-EGUs: Unit 612, plant 00001, Dupont-Belle, Kanawha County; Unit 006, plant 00001, Elkem Metals Company L.P.—Alloy Plant, Fayette County; Units 001 and 003, plant 00002, PPG Industries, Inc., Marshall County; Units 010, 011, and 012, plant 00007, Aventis Cropscience, Kanawha County; and Unit 0B6, plant 00003, Union Carbide—South Charleston Plant, Kanawha County;

4. Riley Bark Boiler, Plant 0159, Blue Ridge Paper Products Company, Haywood County, North Carolina (“Blue Ridge”); and

5. Unit 0056, plant K3249, Michigan State University, Ingham County, Michigan (“Michigan State”).

In the December 2000 proposed rule, EPA discussed in detail the circumstances concerning EPA's original determinations in the January 2000 final rule of the allocations for these units. 65 FR 80398, 80399-400 (December 21, 2000). EPA then evaluated these circumstances and provided the reasons for the proposed conclusion that the respective units' allocations in the January 2000 final rule should be revised. In particular, EPA proposed to find, for the stranded units and Birchwood, that the owners did not have a reasonable opportunity to comment on the allocations for their units. EPA proposed that the allocations should be revised based on corrected data. 65 FR 80400. With regard to all non-EGUs in West Virginia, EPA proposed to find that the owners of the units agreed that the allowances had been incorrectly distributed among the units due to the submission of erroneous data to EPA. EPA proposed that the allowances should be redistributed among those units to reflect the distribution agreed upon by those owners. Id. With regard to the Blue Ridge and Michigan State units, EPA proposed to find that it had misinterpreted the comments submitted by the units' owners and proposed that the allocations should be revised to reflect the correct interpretation of those comments. Id.

No commenters objected to the above-described proposed findings concerning any of the units or to the proposals to revise the units' allocations. Based on the reasons set forth in the December 2000 proposed rule and on the supporting record, EPA is today adopting as final these findings and conclusions.

In addition, one commenter requested that EPA address the status under the NOX Budget Trading Program of two additional units not addressed in the December 2000 proposed rule. Specifically, the commenter requested that EPA determine that one unit for which an allocation is provided in the January 2000 final rule (i.e., Point 004, plant 0006, International Paper—Franklin (formerly Union Camp Corp/Fine Paper Div), Isle of Wright County, Virginia) is not actually a NOX Budget unit and is not subject to the requirements of the NOX Budget Trading Program. The commenter also requested that EPA determine that a second unit that was not allocated allowances (i.e., Unit 17, plant 0006, International Paper—Franklin, Isle of Wright County, Virginia) is actually a NOX Budget unit and subject to the program and should receive an allocation.

With regard to the requested determination that the first unit is not a NOX Budget unit, part 97 already provides a procedure for EPA to make such a determination without revising the regulations. Under § 97.42(g)(1), the Administrator may determine that a unit allocated allowances is not actually a NOX Budget unit and that the Administrator will not record the allocation. Using this procedure, EPA has already issued final determinations that several other units are not NOX Budget units. Since this procedure is available for the unit referenced by the commenter and since issues concerning this unit are in any event outside the scope of the December 2000 proposed rule, EPA is not determining in this rulemaking the status of this unit under the NOX Budget Trading Program. Instead, EPA recently issued a determination under § 97.42(g)(1) concluding that the unit is not a NOX Budget unit.

With regard to the status of the second unit referenced by this commenter, issues concerning this unit are outside the scope of the December 2000 proposed rule. EPA therefore is not addressing these issues, or taking any action, concerning the unit in this rulemaking.3

EPA's general approach to obtaining allowances for revised allocations for the identified units is to adopt methodologies that will result in the least disruption to the Federal NOX Budget Trading Program, while maintaining unchanged the emission reductions required under the program and the existing State EGU and non-EGU budgets that reflect those reductions.

Since the issues concerning the West Virginia non-EGUs (including one “stranded” unit) involve the entire West Virginia non-EGU budget sector, EPA proposed in the December 2000 proposal to obtain allowances for the non-EGUs' revised allocations by redistributing the allocations for that sector. The redistribution will not affect any units other than those needing revised allocations. Further, the redistribution is the least disruptive approach for revising the units' allocations. In fact, since the owners of all the West Virginia non-EGUs have agreed on the amounts of the revised allocations for the units, the owners could have accomplished this redistribution on their own at any time, simply by using the unrestricted trading allowed under the Federal NOX Budget Trading Program to transfer allowances among the units.

No commenters objected to this approach for revising the allocations for the West Virginia non-EGUs. For the above reasons, EPA adopts this approach.

For the other units identified above, EPA proposed in the December 2000 proposal to use first the allowances that were allocated in the January 2000 final rule to units that EPA subsequently determined not to be NOX Budget units. To the extent an insufficient amount of allowances were available from such non-NOX Budget units, EPA proposed to use allowances from the compliance supplement pool. In the December 2000 proposal, EPA stated that there were sufficient allowances available for non-NOX Budget units to provide allowances for all of the identified units except the Birchwood unit. Thus, under the proposal, non-NOX Budget units would provide all additional allowances for all the identified units except the Birchwood unit, which would receive some but not all of its additional allowances from non-NOX Budget units.

The most accurate approach for providing revised allocations for the “stranded”, Birchwood, Blue Ridge, and Michigan State units would be to recreate the allocations that would have resulted if EPA had originally used the correct data for them when the allocations were established in the January 2000 final rule. This approach would require reallocating allowances for each, entire budget sector (i.e., the EGU or non-EGU sector for a given State) that includes one or more of these five units.

This is because, if the two “stranded” units 4 and the Birchwood, Blue Ridge, and Michigan State units had been provided the proper number of allowances in the January 2000 final rule, the allocations for all units in their respective budget sectors in their respective States would have been affected. Under § 97.42(b) and (c), each existing unit is allocated its proportionate share of the budget for its respective sector (EGU or non-EGU) for its respective State. For example, allocations for an EGU in a given State are determined by: multiplying an emission rate (0.15 lb/mmBtu) times each unit's historical heat input; totaling the results for all EGUs in the State; and adjusting each EGU's allocation proportionately until the total number of allowances allocated to the EGUs in the State equals 95 percent of the State's EGU budget. Non-EGU allocations are determined in the same way except that the emission rate (0.17 lb/mmBtu) is different and the allocations must equal 95 percent of the non-EGU budget.

Consequently, if EPA were to take the approach of recreating the original allocations based on the correct data, the allocations of all units in each entire budget sector would be revised. Further, because there would then be more units receiving allocations than in the original allocation process, each unit (other than the two “stranded” units and the Birchwood, Blue Ridge, and Michigan State units) would have a reduced allocation.

As explained in the December 2000 proposal, EPA believes that this approach would result in disruption of the Federal NOX Budget Trading Program, and for the units in the program, far out of proportion to the scope of the problem. No commenters supported this approach to providing revised allocations for the “stranded”, Birchwood, Blue Ridge, and Michigan State units. For the above reasons, EPA concludes that it should adopt an approach that is less disruptive to the Federal NOX Budget Trading Program and the units in the program than a full reallocation of allowances to all units in each, entire budget sector.

i. Use of allocations to non-NOX Budget units.

EPA stated in the December 2000 proposed rule that using allowances that were allocated mistakenly under the January 2000 final rule to units that were not actually NOX Budget units is the least disruptive method of providing allowances for the revised allocations. Appendices A and B of the January 2000 final rule list the allocations for specific units thought to be NOX Budget units. Under § 97.42(g)(1)(i), if EPA subsequently determines that any unit in Appendix A or B is not actually a NOX Budget unit, the Administrator will not record the listed allocations in an account for the unit. Instead, the Administrator will record the allocations in the allocation set-aside for new units in the State in which the unit is located, in addition to the 5 percent of the EGU and non-EGU budgets already comprising the set-aside. 40 CFR 97.42(g)(2).5 EPA concluded in the December 2000 proposed rule, that revising NOX Budget units' allocations using allowances mistakenly allocated to non-NOX Budget units is the approach that is the least disruptive of reasonable expectations of owners and operators and, thus, of compliance planning for NOX Budget units. See 65 FR 80402.

Two commenters claimed that revising allocations using allowances made available through determinations under § 97.42(g)(1) would disrupt compliance planning. These commenters note that, under the existing regulations, allowances originally allocated to units determined not to be NOX Budget units are added to the allocation set-aside for new units. One of the commenters claims that “it is reasonable that companies planning” new units “would have factored into their compliance plans assumptions concerning the availability * * * of allowances freed up” under § 97.42(g) determinations, including those determinations “made several months ago.”

However, in establishing this mechanism for correcting allocations to non-NOX Budget units, EPA stated that it expected that such allocations would occur “rarely, if ever.” 65 FR 2707. EPA's intent, of course, was not to make errors resulting in allocations to non-NOX Budget units, and there was no reason for owners and operators to assume that there would be errors or rely on such an assumption. On the contrary, since EPA stated that the mechanism for correcting such errors would rarely be needed, owners and operators of new units had no reasonable expectation that the mechanism would ever be used and that any incorrectly allocated allowances would be added to the allocation set-aside.

Moreover, the commenter speculated, without providing any support, that owners and operators changed their compliance planning for new units during the few months between June-August 2000, when the bulk of the § 97.42(g) determinations were issued, and December 2000 when EPA issued the proposal to revise allocations for the identified units using allowances from these § 97.42(g) determinations. For example, the commenter provides no evidence that any owner or operator incurred expenses, or made decisions, concerning compliance of its units on the assumption that allowances would be available for the units under § 97.42(g). The commenter's unsupported speculation warrants little or no weight. Further, the relatively short period during which the owners and operators could have thought that such allowances would be available was unlikely to result in any significant changes in compliance planning. On balance, EPA concludes that owners and operators did not reasonably rely, to any significant extent, on the availability of allowances under § 97.42(g) for new units.

The commenters objecting to using non-NOX Budget units' allowances to provide allowances to the two “stranded” units and the Birchwood, Blue Ridge, and Michigan State units also argued that EPA should increase the State trading budgets by the amounts of the additional allowances to be provided to the identified units. However, the commenters ignore the fact that if, in setting the State EGU and non-EGU budgets, EPA had originally used the correct data concerning the non-NO X Budget units mistakenly allocated allowances, the State EGU or non-EGU budgets in which the non-NOX Budget units were included in the January 2000 final rule would have been lower and therefore the total number of allowances allocated under those budgets would have been less.

This is because all of the non-NOX Budget units mistakenly allocated allowances had heat input values that were used to calculate the respective State EGU or non-EGU budgets. For example, the State EGU budget for Michigan was based on the total heat input for all large EGUs in 1995, and each of the non-NOX Budget units originally treated as large EGUs in Michigan 6 had heat input values in 1995 that were included in the State EGU budget. Also, the State EGU budgets for North Carolina and Virginia 7 were based on the total heat input for large EGUs in 1996, and each of the non-NOX Budget units originally treated as large EGUs in those States 8 had heat input values in 1995 that were included in the respective State EGU budget. Similarly, the State non-EGU budgets were based on total heat input for large non-EGUs in the respective States in 1995, and all the non-NOX Budget units originally treated as large non-EGUs in those States had heat input values in 1995 that were included in the respective State non-EGU budget.9 Although the treatment of the non-NOX Budget units inflated somewhat the State EGU or non-EGU budgets, EPA did not reduce these budgets when it issued determinations removing the non-NOX budget units from the trading program. Instead, EPA took back the allowances allocated to these non-NOX budget units and provided in part 97 that these allowances would be added to the set-aside for new units in the respective States.

In short, EPA's approach concerning the non-NOX Budget units already somewhat inflated the State EGU or non-EGU budgets. The commenters' approach would compound this result by further increasing State EGU or non-EGU budgets to provide additional allowances to the identified NOX Budget units. In addition, under the commenter's approach of further increasing the EGU or non-EGU budgets of the States involved (i.e., Michigan, North Carolina, and Virginia), those States' budgets would be calculated in a different manner (i.e., with amounts of allowances added to the amounts derived using the generally applied methodology for calculating budgets) than any other States' budgets. EPA maintains that it is reasonable to use the allowances that were mistakenly allocated to non-NOX Budget units, and that somewhat inflated certain State EGU or non-EGU budgets, to provide additional allowances to the identified NOX Budget units, rather than further increasing those State EGU or non-EGU budgets.

According to one of the commenters supporting the approach of increasing the State trading budgets to provide revised allocations, the State trading budget (for Virginia) would have been higher if EPA had originally used the correct historical heat input data for one of the identified units (the Birchwood unit). However, this comment is based on an incorrect factual premise.

Actually, Virginia's trading budget was based on the higher of total EGU heat input in 1995 or 1996, the 1996 total was the higher value, and the Birchwood unit did not commence operation until after the 1996 control period. The incorrect heat input data submitted to, and used by, EPA to set Virginia's EGU budget showed heat input for the Birchwood unit for the 1996 control period. That incorrect value was used to calculate the Virginia budget. Thus, if EPA originally had been provided and had used the correct heat input data for the Birchwood unit, Virginia's EGU budget would be lower than the amount in the January 2000 final rule. The commenter's approach would result in further increase of that budget and would result in Virginia's budget being calculated in a manner inconsistent with other States' budgets.

In summary, EPA concludes that using non-NOX Budget units' allowances has little or no disruptive impact on units in the NOX Budget Trading Program. EPA also maintains that this is a reasonable approach for providing revised allocations for the identified units.

As discussed above, after issuance of the December 2000 proposed rule and during the comment period on that proposal, a commenter informed EPA of a unit, not previously identified, that was allocated allowances in the January 2000 final rule but that is not actually a NOX Budget unit. The issues concerning the status of this unit (i.e., Point 004, plant 0006, International Paper—Franklin (formerly Union Camp Corp/Fine Paper Div), Isle of Wright County, Virginia) as a NOX Budget unit were outside the scope of December 2000 proposed rule and this rulemaking, and there is a separate procedure under § 97.42(g)(1) for addressing such issues. EPA therefore issued a letter under § 97.42(g)(1) on August 1, 2001, in which EPA determined that the unit was not actually a NOX Budget unit. Further, EPA stated in the letter that, consistent with § 97.42(g)(1)(i), the 262 allowances allocated to the unit would not be recorded for the unit.

Consequently, there are 262 additional allowances that were mistakenly allocated to a non-NOX Budget unit in Virginia and that are available under the approach proposed in the December 2000 proposal for providing additional allowances to the Birchwood unit. As a result, there are sufficient allowances available from non-NOX Budget units in Virginia to provide the full amount of additional allowances necessary for the Birchwood unit.10

ii. Use of compliance supplement pool or allocation set-aside allowances.

In the December 2000 proposed rule, EPA stated that using allowances from the State compliance supplement pool was the next least disruptive method of providing allowances for the revised allocations, after the use of non-NOX Budget units' allowances.EPA explained that use of the compliance supplement pool allowances would be less disruptive than using allowances from the allocation set-aside, which is used for allocations to new units. See 65 FR 80403.

However, as discussed above, EPA has determined that there are sufficient allowances available from non-NOX Budget units to provide allowances for all of the identified units, including the Birchwood unit. There is no need to use the compliance supplement pool for any State in which the identified units are located to provide any allowances needed for the units' revised allocations. For the reasons discussed below, EPA concludes that non-NOX Budget units should provide all additional allowances for all the identified units.

First, EPA maintains that use of non-NOX Budget units' allowances is less disruptive to the NOX Budget Trading Program and units in the program than using allowances from the compliance supplement pool. The purpose of the pool is to provide additional allowances for 2003 and 2004 above and beyond the State EGU and non-EGU budgets for units “that are unable to meet the compliance deadline” during those years. 63 FR 57356, 57428 (October 27, 1998) (explaining purpose of pool in NOX SIP call); see also 64 FR 28250, 28310 (May 25, 1999) (adopting pool in Federal NOX Budget Trading Program for same reasons as in NOX SIP call). The compliance deadline is feasible without the compliance supplement pool. However, the additional allowances in this pool will ensure that any units unable to install NOX control equipment (e.g., because of concerns for reliability of electric generation during a shutdown for installation) in 2003 or 2004 are able to obtain allowances in the meantime. See 63 FR 57428.

The compliance supplement pool allowances are initially distributed to units that make early NOX emission reductions. Owners and operators of units that reduce the units' NOX emissions below a specified level after 2000 and before 2003, the year when the control requirements of the Federal NOX Budget Trading Program first take effect, may apply for compliance supplement pool allowances. 40 CFR 97.43(a). Owners and operators of units in the Ozone Transport Commission NOX Budget Program may also apply for compliance supplement pool allowances to the extent the units have banked allowances for 2000 or 2001 under that program. 40 CFR 97.43(b). Although the compliance supplement pool is distributed to units with early reductions or with banked allowances under the Ozone Transport Commission NOX Budget Trading Program, units “that need extra allowances for compliance will have access to them through the allowance market.” 65 FR 2714. EPA provided credit for early reductions “merely as a mechanism for managing the [compliance supplement pool], not as an independent program with a purpose separate from that of the [compliance supplement pool]”. State of Michigan v. EPA, 213 F.3d 663, 694 (D.C. Cir. 2000).

However, EPA recognizes that using some of the compliance supplement pool allowances for revised allocations would reduce the amount of allowances potentially available for early reductions. Each State has a fixed number of allowances in the State compliance supplement pool. See 65 FR 2767 (Appendix D showing compliance supplement pool for each State). Using the pool would make fewer allowances potentially available for early reductions and so would be more disruptive to the Federal NOX Budget Trading Program and other units than using non-NOX Budget unit allowances.

Second, using allowances from the allocation set-aside, would also be more disruptive than using non-NOX Budget unit allowances. The allocation set-aside is allocated to new units for years before they have the necessary historical data to be treated as existing units in future allocation updating. The allocation set-aside therefore plays an important role of integrating new units into the NOX Budget Trading Program. EPA set the allocation set-aside at 5% of the State EGU and non-EGU budgets so that the pool would be large enough to accommodate all new sources. EPA is concerned that using allowances from the allocation set-aside to revise the identified units' allocations may result in fewer allowances being available for individual new units. See 65 FR 80403. EPA notes that no commenter indicated a preference for using allowances from the allocation set-aside (or from the compliance supplement pool), in lieu of non-NOX Budget units' allowances.

In summary, EPA concludes that the compliance supplement pool or allocation set-aside allowances should not be used to obtaining allowances for any of the identified units.

In the December 2000 proposed rule, EPA proposed the amounts of allowances to use for the units' revised allocations. For the West Virginia non-EGUs (including one “stranded” unit), EPA proposed to use the allocations requested by all the owners of those units. 65 FR 80403. EPA did not receive any comments objecting to these revised allocations. For the reasons set forth in the proposed-rule preamble, today's final rule adopts these revised allocations.

EPA also proposed in the December 2000 proposal to calculate the revised allocations for two “stranded” units and the Birchwood, Blue Ridge, and Michigan State units by using the average emission rate underlying the allocations for the respective unit's State budget sector (EGUs or non-EGUs) in Appendix A or B in the January 2000 final rule. Specifically, as discussed above, the allocations to each EGU in Appendix A or non-EGU in Appendix B are calculated by multiplying the unit's historical heat input by an initial average emission rate (0.15 lb/mmBtu for EGUs and 0.17 lb/mmBtu for non-EGUs) and then adjusting the results so that the total of the allocations to all EGUs or all non-EGUs in the unit's State equals 95 percent of the State EGU budget or State non-EGU budget respectively. Thus, all EGU allocations for the State have a common underlying average emission rate, and all non-EGU allocations for the State have a common underlying average emission rate, which may differ from that for EGU allocations.

In calculating allocations for the “stranded”, Birchwood, Blue Ridge, and Michigan State units, EPA proposed to use the underlying average emission rate for units in the State budget sector in the same State as the respective unit. EPA proposed to multiply each unit's historical heat input (calculated under § 97.42(a))by the appropriate underlying average emission rate. See 40 CFR 97.42(a) (establishing 1995-1998 as the historical period for 2003-2007 allocations); and Memorandum on Calculation of Revised Allocations, Document No. XIV-B-01(showing how the revised allocations are calculated and attaching the supporting documentation of the heat input data).

EPA did not receive any comments objecting to the proposed methodology for calculating the revised allocations. One commenter stated that the revised allocation listed in the proposed rule language for one unit (Unit 005, plant 0159, Blue Ridge Paper Products Inc., Haywood County, North Carolina) was incorrect. In considering the comment, EPA found that the amount of the allocation as reflected in the Memorandum on Calculation of Revised Allocations in the record was different than the number listed in the proposed rule language for the unit. EPA agrees that the amount in the memorandum is correct and that the number in the proposed rule is wrong. In today's final rule, EPA is correcting the allocation for the Blue Ridge unit to be consistent with the memorandum in the record and is otherwise adopting the revised allocations in the proposed rule, based on the reasons set forth above and on the supporting record.

In today's final rule, EPA is adopting the following revisions to the language of specific sections of part 97.

EPA is adopting several rule revisions to implement the above-described revised allocations and approach for obtaining allowances for those allocations. First, today's final rule revises Appendices A and B to part 97 in order to include revised allocation amounts for the identified units as discussed above. In addition, when Appendix A or B incorrectly references an identified unit or fails to list the unit at all, EPA is correcting these errors.

Second, today's final rule revises Appendices A and B to remove allocations for units that EPA has previously determined not to be NOX Budget units. Included in these revisions is the removal of the unit, noted above, that EPA recently determined was a non- NOX Budget unit for which allowances should not be recorded.11 As discussed above, under § 97.42(g), the Administrator may determine that a unit allocated allowances in Appendix A or B does not meet the applicability requirements in § 97.4 and so is not actually a NOX Budget unit. In response to requests for such determinations, EPA has issued final determinations that 4 units listed in Appendix A and 28 units listed in Appendix B are not NOX Budget units and will not have allocations recorded in their accounts. No commenters on the December 2000 proposed rule objected to reflecting final determinations under § 97.42(g) in revisions to the appendices. Appendix A. Today's final rule merely reflects, in regulatory text, these final determinations.

In the December 2000 proposal, EPA proposed revisions to § 97.42 (allocation procedures) that would authorize the Administrator to issue orders correcting other units' allocations, where correction was warranted, using allowances allocated to units determined not to be NOX Budget units. Under the proposed revisions, the Administrator could determine that the number of allowances actually allocated to an existing NOX Budget unit for 2003-2007 in Appendix A or B is less than the number of allowances provided under § 97.42(a) through (d) and that equitable considerations warranted correction of such unit's allocation. The Administrator could also determine that the number of allowances actually allocated to a new NOX Budget unit for 2003-2007 or to any NOX Budget unit for 2008 or thereafter, using procedures in § 97.42(a) through (d), was less than the number of allowances provided under § 97.42(a) through (d) and that equitable considerations warranted correction of such unit's allocation. Moreover, in the order, the Administrator could determine that allowances mistakenly allocated to non- NOX Budget units located in the same State as the unit would be used to supplement, and thereby correct, the unit's actual allocation. EPA stated that the use of orders—rather than rule revisions—to make unit-specific allocations from allocations to non- NOX Budget units would allow for much more expeditious correction of a unit's allocations where correction was warranted and still provide opportunity for interested parties to submit objections.

Several commenters objected to the proposed revision of § 97.42(g) on the ground that, among other things, State budgets should be increased to provide additional allowances for units whose original allocations were incorrect and warranted an increase. The commenters also claimed that the proposed revision provided fewer procedural protections for participants and other members of the public than provided through a rulemaking proceeding. As discussed above, EPA concludes above that there is no basis for increasing the State budgets to provide additional allowances for the units specifically identified in this final rule as warranting increased allocations. Further, additional procedural protections (if any were necessary) could be provided in a final rule. However, EPA has decided that the most prudent course is to retain—at this time—the flexibility to address case-by-case the issue of how to obtain additional allowances for any other units that EPA may determine in the future warrant increased allocations, rather than deciding that question on a generic basis now by adopting the proposed revisions. EPA is therefore not taking action in today's final rule on the proposed revisions to § 97.42(g).12

In the December 2000 proposal, EPA proposed alternative revisions that would provide allowances from the State compliance supplement pool for the Birchwood unit. EPA proposed to revise § 97.43 to add a new paragraph (c)(9) that would specifically allocate to the Birchwood unit in Virginia 725 allowances from the Virginia compliance supplement pool. The new provisions also would address the interaction of this unit-specific allocation with other provisions of the rule concerning compliance supplement pool allowances. As discussed above, there are now sufficient non- NOX Budget unit allowances to satisfy the revised allocation for the Birchwood unit. The proposed new paragraph (c)(9) is therefore unnecessary, and EPA has decided not to adopt that revision.

In the December 2000 proposal, EPA also proposed to revise § 97.43 to add a new paragraph (d) that would authorize the Administrator, on a generic basis, to issue orders determining that the number of allowances allocated in Appendix A or B (or using § 97.42(a) through (d) procedures) for a unit was less than the number of allowances provided under § 97.42(a) through (d) and that equitable considerations warrant correction of such allocation. The Administrator could also determine in the order that allowances in the compliance supplement pool of the State where the unit is located would be used to supplement, and thereby correct, the unit's allocation.

Several commenters objected to the proposed new paragraph (d) of § 97.43 on the ground that, among other things, State budgets should be increased to provide additional allowances for units whose original allocations were incorrect and warranted an increase. The commenters also claimed that the proposed revision provided fewer procedural protections for participants and other members of the public than provided through a rulemaking proceeding. As discussed above, EPA concludes above that there is no basis for increasing the State budgets to provide additional allowances for the units specifically identified in this final rule as warranting increased allocations. Further, additional procedural protections (if any were necessary) could be provided in a final rule. However, EPA has decided that the most prudent course is to retain—at this time—the flexibility to address on a case-by-case basis the issue of how to obtain additional allowances for any units that EPA may determine in the future warrant increased allocations, rather than deciding that question on a generic basis now by adopting the proposed revisions. EPA is therefore not taking action in today's final rule on the proposed revisions to § 97.43.

Under Executive Order 12866 (58 FR 51735 (October 4, 1993)), the Agency must determine whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that today's final rule is not a “significant regulatory action” under the terms of Executive Order 12866 and, therefore, is not subject to OMB review.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601, et seq., as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA), Pub. L. No. 104-121, generally requires the Agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the Agency certifies that the rule will not have a significant, economic impact on a substantial number of small entities. Such entities include small businesses, small organizations, and small governmental jurisdictions.

In determining whether a rule has a significant, economic impact on a substantial number of small entities, the impact of concern is any significant, adverse, economic impact on small entities since the primary purpose of the regulatory flexibility analysis is to identify and address regulatory alternatives “which minimize any significant, economic impact of the proposed rule on small entities.” 5 U.S.C. 603 and 604.

Today's final rule revision is not significant enough to change the regulatory burden or economic impact of the existing Federal NOX Budget Trading Program rule. Moreover, for virtually all NOX Budget units addressed, the final rule either increases the number of allowances allocated and thus reduces the burden of the program or does not change the number of allowances allocated and thus does not change the program burden. To the extent the final rule removes certain units from the allocation tables, EPA has already issued final orders removing the allocations for these units, and the final rule has no effect other than to update the allocation tables to make them consistent with those orders. Only one unit's allocation is reduced by today's final rule, and the owners of that unit, agreeing that the unit's original allocation was erroneously overstated, requested EPA to make the reduction.

For these reasons, I certify that today's final rule will not have a significant, economic impact on a substantial number of small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, 2 U.S.C. 1532, the Agency generally must prepare a written statement, including a cost-benefit analysis, for any proposed or final rule with “Federal mandates” that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. Section 205 of the UMRA generally requires that, before promulgating a rule for which a written statement is needed, EPA must identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why the alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with regulatory requirements.

EPA has determined that today's final rule does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector in any one year. For the reasons discussed above, today's final rule revision is not significant enough to change the overall regulatory burden or economic impact of the Federal NOX Budget Trading Program rule on any parties, including State, local or tribal governments. Accordingly, little or no additional costs to State, local, or tribal governments in aggregate, or to the private sector, will result from the final rule. Similarly, EPA has determined that today's final rule contains no regulatory requirements that might significantly or uniquely affect small governments. Thus, today's final rule is not subject to the requirements of sections 202, 203, or 205 of the UMRA.

Today's final revisions to part 97 will not impose any new information collection burden subject to the Paperwork Reduction Act (44 U.S.C. 3501, et seq.). Today's final rule does not change either the scope of the units covered by, or the information requirements for units under, the Federal NOX Budget Trading Program.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Copies of the previously submitted Information Collection Request concerning the Federal NOX Budget Trading Program may be obtained from the Director, Regulatory Information Division; EPA; 401 M St. SW (mail code 2137); Washington, DC 20460 or by calling (202) 564-2740.

The Executive Order 13045 (62 FR 19885 (April 23, 1997)) applies to any rule that the Agency determines (1) is “economically significant” as defined under Executive Order 12866 and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, EPA must evaluate the environmental health or safety effects of the planned rule on children and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by EPA.

Today's final rule is not subject to Executive Order 13045 because it is not “economically significant” as defined under Executive Order 12866. Further, EPA does not have reason to believe that the environmental health risks or safety risks addressed by this action present a disproportionate risk to children.

Executive Order 12898 requires that each Federal agency make achieving environmental justice part of its mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of its programs, policies, and activities on minorities and low-income populations.

Today's final rule does not have a disproportionately high and adverse human health or environmental effects on minorities and low-income populations.

Executive Order 13132, entitled “Federalism” (64 FR 43255 (August 10, 1999), requires the Agency 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” are 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.”

Today's final rule does not have federalism implications. It will not 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, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

This final rule does not have tribal implications. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. This final rule does not anticipate substantial compliance cost expenditures by tribal governments nor substantial direct effects on cultural practices of tribes. Thus, Executive Order 13175 does not apply to this rule.

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, directs the Agency to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

Today's final rule does not involve any technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

This rule is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it is not a significant regulatory action under Executive Order 12866.

The Congressional Review Act, 5 U.S.C. 801 et.seq. (CRA), as added by the Small Business Regulatory Enforcement Fairness Act of 1966, does not apply because this action is not a rule, for purposes of 5 U.S.C. 8014(3). This action qualifies as a rule of particular applicability because its application is limited to specifically named entities, and as such, it is exempt from the CRA.

For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:

You may be potentially 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/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301162. 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, 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, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is revising the tolerances for residues of the fungicide propamocarb hydrochloride, propyl [3-(dimethylamino)propyl] carbamate monohydrochloride, by increasing the residue levels in or on tomato and tomato, paste, to 2 and 5 ppm, respectively, and removing the level for tomato, puree. These revised tolerances will expire and are revoked on December 31, 2003. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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. . . .”

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

Failure to control late blight in tomatoes with the registered fungicides have been caused almost exclusively by immigrant strains of late blight (Phytophthora infestans), which are resistant to the control of choice, metalaxyl. Before the immigrant strains of late blight arrived, all of the strains in the United States were previously controlled by treatment with metalaxyl. Presently, there are no fungicides registered in the United States that will provide adequate control of the immigrant strains of late blight. EPA has authorized under FIFRA section 18 the use of propamocarb hydrochloride on tomato for control of late blight in California. After having reviewed the submission, EPA concurs that an emergency condition exists for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of propamocarb hydrochloride in or on tomato and tomato paste. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is revising these tolerances without notice and opportunity for public comment as provided in section 408(l)(6). Although these tolerances will expire and are revoked on December 31, 2003, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerances remaining in or on tomato and tomato paste after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed the levels that were authorized by these tolerances at the time of that application. 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.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 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 propamocarb hydrochloride and to make a determination on aggregate exposure, consistent with section 408(b)(2), for time-limited tolerances for residues of propamocarb hydrochloride in or on tomato and tomato paste at 2 and 5 ppm, respectively ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerances follows.

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

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

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

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

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.499) for the residues of propamocarb hydrochloride, in or on potatoes. Time-limited tolerances for inadvertent residues have been established in or on wheat and wheat by-products. In addition, time-limited tolerances for residues in or on tomato and tomato, paste, and puree have also been established at levels lower than those described in this document. Risk assessments were conducted by EPA to assess dietary exposures from propamocarb hydrochloride in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Acute analyses were performed for females 13-50 years old and the general U.S. population (including infants and children); the acute risk was analyzed at the 95th percentile. The aPAD for females 13-50 years old and the general U.S. population (including infants and children) are 1.5 mg/kg/day and 2.0 mg/kg/day, respectively. For acute dietary risk estimates, EPA's level of concern is >100% aPAD. The results of the acute analysis indicate that the acute dietary risk estimates for the general U.S. population and all population subgroups (at the 95th percentile) associated with the proposed uses of propamocarb hydrochloride do not exceed EPA's level of concern.

ii. Chronic exposure. In conducting this chronic dietary risk assessment, the DEEMTM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: A chronic analysis was performed for the general U.S. population and all population subgroups. The cPAD for the general U.S. population and all subgroups is 0.12 mg/kg/day. For chronic dietary risk estimates, EPA's level of concern is >100% cPAD. The results of the chronic analysis indicate that the chronic dietary risk estimates for the general U.S. population and all population subgroups associated with the proposed uses of propamocarb hydrochloride do not exceed EPA's level of concern.

iii. Cancer. There is no concern for mutagenic potential, and there is no evidence of carcinogenic potential in either the rat or mouse. Propamocarb hydrochloride has been classified as “not likely to be carcinogenic in humans.” Therefore, a cancer dietary exposure analysis was not performed.

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

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

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

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

Based on the GENEEC and SCI-GROW models the EECs of propamocarb hydrochloride for acute exposures are estimated to be 1,030 parts per billion (ppb) for surface water and 2.08 ppb for ground water. The EECs for chronic exposures are estimated to be 340 ppb for surface water and 2.08 ppb for ground water.

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

Propamocarb hydrochloride is currently registered for use on the following residential non-dietary sites: Turfgrass and ornamentals at residential, recreational and golf course sites. However, the usage information in the 1995 Reregistration Eligibility Decision (RED) for propamocarb hydrochloride and the label statement that only protected handlers may be present in the treated area during application, indicate that only commercial applicators will apply the registered end-use product Banol (EPA Registration Number 432-942, contains 66.5% propamocarb hydrochloride) mainly on golf courses and there will be no use on residential or recreational turf. The risk assessment was conducted using the following residential exposure assumptions: An MOE of 100 is adequate to ensure protection from propamocarb hydrochloride via the dermal and inhalation routes for residential exposures. The high-end scenario for residential post-application exposure is the golf course use. The post-application risk assessment is based on generic assumptions as specified by the newly proposed Residential Standard Operating Procedures (SOPs) and recommended approaches by Health Effects Division's (HED's) Exposure Science Advisory Committee. Short-term post-application exposures are expected for the adult and adolescent golfer. Golfer exposure is expected through minimal hand contact with the golf ball and dermal contact to the lower legs from treated plant surfaces. Since it is assumed that the adolescent golfer would have a proportionally similar exposure to adults, a dermal post-application assessment was performed for the adult golfer only. The calculated MOE for the golfer is 980 and, therefore, does not exceed EPA's level of concern. Since the short- and intermediate-term toxicological endpoints are the same, the golfer post-application exposure assessment is expected to provide adequate exposure estimates for both the short- and intermediate-term. In the event of intermediate-term exposure, propamocarb hydrochloride residues are expected to dissipate over time. Therefore, this assessment is expected to present a high-end conservative estimate of actual exposure.

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

ii. Prenatal and postnatal sensitivity. There is no evidence of quantitative or qualitative enhanced susceptibility to infants and children. In the rat, developmental effects occur only at doses that cause mortality in the dams. The maternal LOAEL of 740 milligrams active ingredient/kilogram/day (mg a.i./kg/day) is based on mortality. The maternal NOAEL is 221 mg a.i./kg/day. The developmental LOAEL of 740 mg a.i./kg/day is based on increased gestation day (GD) 20 fetal death and a possible increase in minor skeletal anomalies. The developmental NOAEL is 221 mg a.i./kg/day. In the rabbit, developmental effects occur only at doses where there is maternal toxicity. EPA believes that the post implantation loss is actually due to the increased abortions in the does. The maternal LOAEL of 300 mg a.i./kg/day is based on decreased body weight gains for GD 6-18 and possible increased abortions. The maternal NOAEL is 150 mg a.i./kg/day. The developmental LOAEL of 300 mg a.i./kg/day is based on increased post-implantation loss. The developmental NOAEL is 150 mg a.i./kg/day. In the reproduction toxicity study, offspring effects only occurred at levels resulting in maternal toxicity. The LOAEL for systemic/parental toxicity is 8,000 ppm based on decreased body weights of F0 and F1 adults. The systemic/parental toxicity NOAEL is 1,250 ppm.

2. Conclusion. There is a complete toxicity data base for propamocarb hydrochloride and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because the prenatal and postnatal toxicology data base is complete and there is no indication of increased susceptibility. A developmental neurotoxicity study is not required. The dietary (food and drinking water) exposure assessments will not underestimate the potential exposures for infants and children from the use of propamocarb hydrochloride.

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

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to propamocarb hydrochloride will occupy 1% of the aPAD for the U.S. population, 1% of the aPAD for females 13 years and older, 3% of the aPAD for all infants (< 1 year old); and 3% of the aPAD for children 1-6 years old. In addition, despite the potential for acute dietary exposure to propamocarb hydrochloride in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of propamocarb hydrochloride in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to propamocarb hydrochloride from food will utilize 7% of the cPAD for the U.S. population; 9% of the cPAD for all infants < 1 year old; and 23% of the cPAD for children 1-6 years old. It has been assumed that there are no residential uses for propamocarb hydrochloride that result in chronic residential exposure to propamocarb hydrochloride. Based on the use pattern, chronic residential exposure to residues of propamocarb hydrochloride is not expected. In addition, despite the potential for chronic dietary exposure to propamocarb hydrochloride in drinking water, after calculating DWLOCs and comparing them to conservative model EECs of propamocarb hydrochloride in surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Propamocarb hydrochloride is currently registered for use(s) that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for propamocarb hydrochloride.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 950, 1,100 and 1,100 for females 13-50 years old, males 13-19 years old and the general U.S. population, respectively. The short-term aggregate risk assessment estimates risks likely to result from 1-7 day exposure to propamocarb hydrochloride residues in food, drinking water, and residential pesticide uses. High-end estimates of the residential exposure are used in the short-term assessment. Average values are used for food and drinking water exposure.

For short-term aggregate exposure risk, the oral and dermal exposures can be combined since both are based on the same toxicity endpoint (decreased body weight). An MOE of 100 is adequate to ensure protection from propamocarb hydrochloride via the dermal route for residential exposures.

According to the 1995 RED for propamocarb hydrochloride (Estimated Usage of Pesticide, p. 3), “almost all usage of propamocarb hydrochloride in the United States is concentrated on golf courses with approximately 100,000 to 200,000 pounds (lb) active ingredient (ai) applied per year.” The label for Banol states that only protected handlers may be present in the treated area during application. For these reasons, it is assumed that this product will be used by commercial applicators, mainly on golf courses. The high-end scenario for residential post-application exposure is the golf course use of Banol. Therefore, in aggregating short-term risk, the Agency considered background chronic dietary exposure (food and drinking water) and short-term golfer dermal exposure. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of propamocarb hydrochloride in ground water and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account non-dietary, non-occupational exposure plus chronic exposure to food and water (considered to be a background exposure level). The short-term aggregate assessment adequately addresses both the short- and intermediate-term golfer dermal exposures. The short- and intermediate-term dermal endpoints were chosen from the 21-day dermal rabbit toxicity study. The short-term golfer exposure was calculated assuming 1-7 day exposure to propamocarb hydrochloride. The intermediate-term aggregate risk assessment estimates risks likely to result from 7 days to 3 months exposure. In the event of intermediate-term exposure, propamocarb hydrochloride residues are expected to dissipate over time. Therefore, the short-term aggregate assessment is expected to present a high-end conservative estimate of intermediate-term risk. As the short-term aggregate risk assessment represents the high-end scenario, an intermediate-term assessment was not performed.

5. Aggregate cancer risk for U.S. population. An aggregate cancer risk analysis was not performed since there is no concern for mutagenic potential and there is no evidence of carcinogenic potential in either the rat or mouse. Propamocarb has been classified as “not likely to be carcinogenic in humans.”

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

A gas chromatography method was utilized for the determination of propamocarb hydrochloride residues in/on raw agricultural commodity samples collected from the potato field study and field rotational crop study. The reported limit of quantitation was 0.05 ppm. The method validation and concurrent method recovery data indicate that this method is adequate to support the time-limited tolerances associated with this action. An identical method is proposed for tolerance assessment. The proposed method has undergone a successful independent lab validation and petition validation method. EPA concludes that the requirements for a plant enforcement method have been fulfilled.

A ruminant feeding study is required. Conclusions about the need for livestock tolerances and appropriate enforcement analytical method are deferred until receipt of the ruminant feeding study and determination of the residues of concern in livestock.

The method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

A CODEX MRL of 1 mg/kg has been established for residues of propamocarb per se in/on tomatoes. The use pattern used for determining the CODEX MRL differs from that in this section 18 exemption (maximum use rate overseas is 3.2 lb a.i./acre per application, the maximum use rate in the United States is 0.9 lb a.i./acre. No Canadian or Mexican residue limits have been established.

The conditions of registration will include submission of a livestock feeding study (which determines the metabolites N-oxide propamocarb, 2-hydroxy propamocarb and oxazolidine) and storage stability data from the livestock feeding study. The need for a livestock analytical enforcement method and livestock tolerances will be determined after receipt of the ruminant feeding study and determination of the residues of concern in livestock. A corrosion characteristics study must be submitted as soon as completed.

Therefore, the tolerances are revised for residues of propamocarb hydrochloride, propyl [3-(dimethylamino)propyl]carbamate monohydrochloride, in or on tomato and tomato, paste at 2 and 5 ppm, respectively. In addition, the tolerance for residues of propamocarb hydrochloride in or on tomato puree is hereby revoked.

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-301162 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 November 20, 2001.

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 VII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by the docket control number OPP-301162, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule revises and revokes 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 (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a FIFRA section 18 exemption under 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 (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4).

For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.”

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

You may be 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.” A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301174. 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 30, 2001 (66 FR 29317) (FRL-6782-2), 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 pesticide petitions (PP) for tolerances by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. This notice included a summary of the petitions prepared by Zeneca Ag Products, the registrant. There were no comments received in response to the notice of filing.

The petitions requested that 40 CFR 180.507 be amended by establishing tolerances for combined residues of the fungicide azoxystrobin, methyl (E)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate) and its Z-isomer (methyl (Z)-2-(2-(6-(2-cyanophenoxy)pyrimidin-4-yloxy)phenyl)-3-methoxyacrylate, in or on food commodities as follows:

1. PP 0E6211 proposed to establish tolerances for strawberry at 10 parts per million (ppm), mint at 30 ppm, grass forage (from grass grown for seed) at 15 ppm, grass (from grass grown for seed) hay at 20 ppm, and watercress, tropical fruits, persimmon, paw paw, tamarind, jackfruit, and loquat at 3.0 ppm. Since “tropical fruits” are not defined for tolerance purposes by EPA, the petition was amended by IR-4 to delete tropical fruits at 3.0 ppm and to add proposed tolerances for acerola, atemoya, avocado, biriba, black sapote, canistel, cherimoya, custard apple, feijoa, guava, ilama, jaboticaba, longan, lychee, mamey sapote, mango, passion fruit, papaya, pulasan, rambutan, sapodilla, soursop, Spanish lime, star apple, starfruit, sugar apple, wax jambu and white sapote at 2.0 ppm. In addition, the proposed tolerance levels for persimmon, paw paw, tamarind, jackfruit and loquat were reduced to 2.0 ppm.

2. PP 1E6238 proposed to establish tolerances for bushberry subgroup, lingonberries, juneberries, and salal at 3.0 ppm.

3. PP 1E6264 proposed to establish tolerances for the leafy Brassica greens subgroup and turnip greens at 25 ppm, and pepper, eggplant and okra at 2.0 ppm.

Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) 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 azoxystrobin on acerola, atemoya, avocado, biriba, black sapote, canistel, cherimoya, custard apple, eggplant, feijoa, guava, ilama, jaboticaba, jackfruit, longan, loquat, lychee, mamey sapote, mango, okra, passion fruit, pawpaw, papaya, pepper, persimmon, pulasan, rambutan, sapodilla, soursop, Spanish lime, star apple, starfruit, sugar apple, tamarind, wax jambu and white sapote at 2.0 ppm; bushberry subgroup, juneberry, lingonberry, salal, and watercress at 3.0 ppm; strawberry at 10 ppm; grass forage at 15 ppm; grass hay at 20 ppm; leafy greens (Brassica) subgroup and turnip (tops) at 25 ppm; peppermint (tops) and spearmint (tops) at 30 ppm. EPA's assessment of 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 azoxystrobin are discussed in Unit III.A. of the Federal Register of September 29, 2000 (65 FR 58404).

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

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

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

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

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.507) for the combined residues of azoxystrobin, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from azoxystrobin in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1 day or single exposure. The Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance level residues were assumed and it was also assumed that 100% of the crops and other commodities with proposed or established azoxystrobin tolerances contained those residues. Anticipated residues, and percent crop treated (PCT) values of less than 100%, were not used.

ii. Chronic exposure. In conducting this chronic dietary risk assessment, the DEEMTM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues were assumed and it was also assumed that 100% of the crops and other commodities with proposed or established azoxystrobin tolerances contained those residues. Anticipated residues, and PCT values of less than 100%, were not used.

iii. Cancer. Since carcinogenicity studies produced no evidence that azoxystrobin is a carcinogen, the Agency concluded that azoxystrobin is unlikely to be a human carcinogen. There is also, as a consequence, no carcinogenicity endpoint, and this analysis was not performed.

2. Dietary exposure from drinking water. Although moderately persistent in soils and stable to hydrolysis, the likelihood of azoxystrobin moving into ground and surface water is low due to high soil/water partitioning coefficients and low single application rates. However, with multiple applications and repeated usage, azoxystrobin and especially its degradate compound 2 may eventually build up in environmental compartments and move into drinking water resources. Compound 2 has greater potential to leach into ground water than the parent as indicated in the terrestrial field studies. In these studies, the parent azoxystrobin remained on the soil surface whereas compound 2 was detected in deeper soil profiles.

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

The Agency uses the First Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI-GROW model is used to predict pesticide concentrations in shallow ground water. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop (PC) area factor as an adjustment to account for the maximum PC coverage within a watershed or drainage basin.

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

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

Based on the FIRST and SCI-GROW models, the estimated environmental concentrations (EECs) of azoxystrobin for acute exposures are estimated to be 170 parts per billion (ppb) for surface water and 0.06 ppb for ground water. The EECs for chronic exposures are estimated to be 33 ppb for surface water and 0.06 ppb for ground water.

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

Azoxystrobin is currently registered for use on the following residential non-dietary sites: turf and ornamentals. The risk assessment was conducted using the following residential exposure assumptions:

Products containing azoxystrobin may be applied to turf 1 to 5 times per year at rates up to 0.95 lb active ingredient (a.i) per acre (i.e., not to exceed 5 lb a.i. per acre per year) and to ornamentals at rates up to 0.75 lb a.i. per acre every 7 to 14 days, but not to exceed 5 lb a.i./acre/year. The currently registered labels do not prohibit homeowners from mixing/loading/applying either the flowable concentrate or the water-dispersible granule formulations. This residential exposure and risk assessment was conducted using the application rate for turf because it is the highest use rate.

Residential handlers may be exposed to azoxystrobin for both short-term dermal and inhalation exposure to azoxystrobin when mixing, loading and applying the formulations. Adults and children may be exposed to azoxystrobin residues from dermal contact with foliage during post-application activities. Toddlers may receive short-term and intermediate-term oral exposure from incidental ingestion during post-application activities.

As no dermal endpoint was selected, a dermal exposure and risk assessment was not conducted for residential handlers or post-application activities. NOAELs of 25 mg/kg/day and 20 mg/kg/day were selected for assessing the risk from short-term and intermediate-term incidental oral exposures, respectively. These same NOAELs were selected for assessing the risks from short-term and intermediate-term inhalation exposures. The level of concern for risk assessment purposes is 100.

No chemical-specific exposure or residue dissipation data for handler or post-application activities were submitted in support of the registered lawn uses. EPA's Draft Standard Operating Procedures (SOPs) for Residential Exposure Assessments, and Recommended Revisions, were used as the basis for all residential handler exposure calculations. Some of the handler exposure data used in this assessment are from the Outdoor Residential Exposure Task Force (ORETF). The task force recently submitted proprietary data to the Agency on hose-end sprayers, push-type granular spreaders, and handgun sprayers. The ORETF data were used in this assessment in place of Pesticide Handler Exposure Data (PHED) for the garden hose-end sprayer scenario. The ORETF data were designed to replace the present PHED data base with higher-confidence, higher quality data that contains more replicates than the PHED data for those scenarios.

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

ii. Prenatal and postnatal sensitivity. Prenatal development studies in rats and rabbits, and a 2-generation reproductive toxicity study in rats did not indicate increased susceptibility of young rats or rabbits to in utero and/or postnatal exposure.

iii. Conclusion. There is a complete toxicity data base for azoxystrobin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency has determined that the 10X FQPA safety factor to protect infants and children should be removed (that is, set to 1) because, in addition to the completeness of the toxicological data base and the lack of increased susceptibility of young rats and rabbits to prenatal and postnatal exposure to azoxystrobin, the unrefined chronic dietary exposure estimates will overestimate dietary exposure, and ground and surface water modeling data produce upper-bound concentration estimates.

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

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to azoxystrobin will occupy 11% of the aPAD for the U.S. population, 11% of the aPAD for females 13 years and older, and 20% of the aPAD for children 1 to 6 years, the subpopulation at greatest exposure. In addition, there is potential for acute dietary exposure to azoxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 2:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to azoxystrobin from food will utilize 12% of the cPAD for the U.S. population, 11% of the cPAD for females 13 to 50 years, and 18% of the cPAD for children 1 to 6 years, the subpopulation at greatest exposure. Based on the use pattern, chronic residential exposure to residues of azoxystrobin is not expected. In addition, there is potential for chronic dietary exposure to azoxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 3:

3. Short-term risk. Short-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Azoxystrobin is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for azoxystrobin. A short-term risk assessment is required for adults because there is a residential handler inhalation exposure scenario. In addition, a short-term risk assessment is required for infants and children because there is a residential post-application oral exposure scenario. As no short-term or intermediate-term dermal endpoint was established, there is no dermal component to these aggregate risk assessments. For adults, the daily inhalation dose is aggregated with the chronic exposure to food and water. For infants and children, the incidental oral exposure from residential post-application activities for infants and children was aggregated with chronic exposure from food and water.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,183 for adults and 490 for children 1 to 6 years. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of azoxystrobin in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Azoxystrobin is currently registered for use(s) that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for azoxystrobin. An intermediate-term risk assessment is not required for adults because residential handler scenarios are not expected to occur for longer than a short-term timeframe. However, an intermediate-term risk assessment is required for infants and children because of the residential post-application oral exposure scenario. As no dermal endpoint was established, there is no dermal component to this aggregate risk assessment. As was necessary for the short-term aggregate assessment, the incidental oral exposure from residential post application activities for infants and children was aggregated with average exposure from food and water.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in an aggregate MOE of 580 for children 1 to 6 years. This aggregate MOE does not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of azoxystrobin in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 5:

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 theFederal Register listings at http://www.epa.gov/fedrgstr/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301178. 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 October 7, 1998 (63 FR 53902) (FRL-6026-3), December 3, 1999 (64 FR 67905) (FRL-6392-6), and June 21, 2000 (65 FR 38535) (FRL-6558-9), EPA issued notices 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 pesticide petitions (PP) for a tolerance by the IR-4, 681 U.S. Highway # 1 South, North Brunswick, NJ 08902-3390 and Zeneca Ag. Products, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE 19850-5458. These notices included summaries of the petitions prepared by Zeneca Ag. Products, the registrant. There were no comments received in response to the notice of filings.

The petitions requested that 40 CFR 180.205 be amended by establishing tolerances for residues of the desiccant, defoliant and herbicide paraquat, 1,1′-dimethyl-4,4′-bipyridinium-ion, derived from application of the dichloride salt (calculated as the cation), in or on various food commodities, as follows:

1. PP 5F1625, submitted by Zeneca Ag. Products, proposed tolerances for field corn and pop corn grain at 0.05 part per million (ppm); field corn and pop corn forage at 3.0 ppm; field corn and pop corn stover at 10.0 ppm. The proposed tolerance for field corn and pop corn grain was increased to 0.1 ppm to harmonize with the Codex maximum residue limit (MRL) of 0.1 ppm for maize.

2. Food additive petition 5H5088, submitted by Zeneca Ag. Products, proposed a food additive tolerance for corn flour at 0.1 ppm. The proposed tolerance for corn flour was subsequently withdrawn since EPA determined that the tolerance for field corn grain at 0.1 ppm is adequate to cover residues in corn flour.

3. PP 1E4019, submitted by IR-4, proposed a tolerance for globe artichoke at 0.05 ppm.

4. PP 9E6026, submitted by IR-4, proposed a tolerance for endive at 0.05 ppm.

5. PP 7E4857, submitted by IR-4, proposed a tolerance with regional registration for dry pea at 0.3 ppm. IR-4 proposed that registration be geographically limited based on the geographical representation of the available residue data (residue data submitted by IR-4 for dry peas are from Washington and Idaho). EPA concluded that there is no need to regionally restrict the registration for dry peas since there is available residue data for dry beans, which also have a tolerance at 0.3 ppm for a similar use of paraquat.

6. 9E6009, submitted by IR-4, proposes a tolerance for persimmon at 0.05 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 residues of paraquat on dry pea; endive; field corn grain, forage and stover; pop corn grain and stover; globe artichoke; and persimmon. EPA's assessment of 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 paraquat are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

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/. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gov/opptsfrs/home/guidelin.htm. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301173. 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 April 8, 1999 (64 FR 17171) (FRL-60712-), September 16, 1999 (64 FR 50280) (FRL-6089 -3), and July 13, 2000 (65 FR 43326) (FRL-6592-9), EPA issued a notices 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 (PP) for a tolerance by Zeneca Ag. Products, now Syngenta Crop Protection, P.O. Box 18300, Greensboro, NC 27419. This notice included a summary of the petition prepared by Zeneca Ag. Products, the registrant. There were no comments received in response to these notices of filing.

The petition announced in the April 8, 1999 notice requested that 40 CFR 180.489 be amended by establishing a tolerance for residues of the herbicide sulfosate, sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine (1:1), in or on fruiting vegetables (except cucurbits) group at 0.05 parts per million (ppm); the edible-podded legume vegetables subgroup at 0.5 ppm (of which no more than 0.3 ppm is trimethylsulfonium (TMS)), the succulent shelled pea and bean subgroup at 0.2 ppm (of which no more than 0.1 ppm is TMS); the dried shelled pea and bean (except soybean) subgroup at 6 ppm (of which no more than 1.5 ppm is TMS); in cattle, goat, hog, sheep, and horse kidney at 3.5 ppm; in cattle, goat, hog, sheep, and horse meat by-products, except liver and kidney, at 2.5 ppm; and to increase the tolerance in cattle, goat, hog, sheep, and horse fat to 0.2 ppm; in cattle, goat, hog, sheep, and horse meat to 0.6 ppm; in cattle, goat, hog, sheep, and horse liver to 0.75 ppm; in milk to 1.1 ppm; in poultry liver to 0.1 ppm; in poultry meat by-products to 0.25 ppm; in or on soybean seed to 21 ppm (of which no more than 13 ppm is TMS); in soybean hulls to 45 ppm (of which no more than 25 ppm is TMS); and in aspirated grain fractions to 1,300 ppm (of which no more than 720 ppm is TMS). The above proposed crop group and crop subgroup were changed to reflect regulations under 40 CFR 180.41(c).

The petition announced in the September 16, 1999 notice requested that 40 CFR 180.489 be amended by establishing a tolerance for residues of the herbicide sulfosate in or on wheat grain at 10 ppm) (of which no more than 2.5 ppm is TMS); wheat hay at 1 ppm (of which no more than 0.5 ppm is TMS); wheat straw at 90 ppm (of which no more than 40 ppm is TMS); wheat bran at 30 ppm (of which no more than 6 ppm is TMS); and wheat shorts at 20 ppm (of which no more than 5 ppm is TMS); and to increase the tolerance in poultry meat by-products to 0.5 ppm and in milk to 2 ppm.

The petition announced in the July 13, 2000 notice requested that 40 CFR 180.489 be amended by establishing a tolerance for residues of the herbicide sulfosate in or on cotton gin by-products at 120 ppm of which no more than 35 ppm is TMS; cotton, undelinted seed at 40 ppm (of which no more than 10 ppm is TMS); leaves of root and tuber vegetables group (except radish) at 0.25 ppm (of which no more than 0.2 ppm is TMS); pistachio at 0.05 ppm; potato flakes at 2 ppm (of which no more than 1.5 ppm is TMS); radish roots at 16 ppm (of which no more than 15 ppm is TMS); radish tops at 10 ppm (of which no more than 8 ppm is TMS); root vegetables subgroup (except radish) at 0.15 ppm (of which no more than 0.1 ppm is TMS); sorghum grain at 35 ppm (of which no more than 15 ppm is TMS); sorghum forage at 0.2 ppm (of which no more than 0.1 ppm is TMS); sorghum stover at 140 ppm (of which no more than 60 ppm is TMS); sweet corn forage at 20 ppm (of which no more than 5 ppm is TMS); sweet corn, kernels + cob with husks removed at 0.15 ppm (of which no more than 0.1 ppm is TMS); sweet corn stover at 165 ppm (of which no more than 65 ppm is TMS); tuberous and corm vegetables subgroup at 1 ppm (of which no more than 0.5 ppm is TMS); and to increase the tolerance in poultry meat by-products to 0.5 ppm and in milk to 2 ppm.

EPA has determined that existing tolerances for cattle, goat, hog, sheep, horse, and milk are adequate to account for existing raw agricultural commodities (RACs) and the other proposed RACs listed above based on calculation of the maximum theoretical dietary burden (MTDB); therefore, new tolerances are not being established for cattle, goat, hog, sheep, horse, and milk. The proposed separate tolerance for poultry liver at 0.1 ppm is not needed because it is covered by the tolerance for poultry meat by-products that is being established at 0.5 ppm; therefore, a tolerance is not being established for poultry liver. EPA has determined that a tolerance is not needed for potato flakes because sulfosate does not concentrate in potato flakes; therefore, a tolerance is not being established for potato flakes. EPA has determined that the appropriate tolerance for leaves of root and tuber vegetables group (except radish) is 0.30 ppm instead of the proposed tolerance of 0.25 ppm, and that the appropriate tolerance for sweet corn stover is 170 ppm instead of the proposed tolerance of 165 ppm. Tolerances were previously established for the soybean commodities and aspirated grain fractions in the Federal Register notice dated June 11, 1999 (64 FR 31505) (FRL-6086-6).

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 sulfosate on cotton, gin by-products at 120 ppm (of which no more than 35 ppm is TMS), cotton, undelinted seed at 40 ppm (of which no more than 10 ppm is TMS), pea and bean, dried shelled (except soybean), subgroup (6C) at 6.00 ppm (of which no more than 1.5 ppm is TMS), vegetable, legume, edible podded subgroup (6A) at 0.50 ppm (of which no more than 0.3 ppm is TMS), vegetable, fruiting group (8) at 0.05 ppm, sorghum, grain, forage at 0.20 ppm (of which no more than 0.10 ppm is TMS), sorghum, grain, grain at 35 ppm (of which no more than 15 ppm is TMS), sorghum, grain, stover at 140 ppm (of which no more than 60 ppm is TMS), vegetable, leaves of root and tuber (except radish) group (2) at 0.30 ppm (of which no more than 0.20 ppm is TMS), pistachio at 0.05 ppm, radish, roots at 16 ppm (of which no more than 15 ppm is TMS), radish, tops at 10 ppm (of which no more than 8.0 ppm is TMS), pea and bean, succulent shelled subgroup (6B) at 0.20 ppm (of which no more than 0.10 ppm is TMS), corn, sweet, forage at 20 ppm (of which no more than 5.0 ppm is TMS), corn, sweet, kernals plus cob with husks removed at 0.15 ppm (of which no more than 0.10 ppm is TMS), corn, sweet, stover at 170 ppm (of which no more than 65 ppm is TMS), vegetable, tuberous and corm subgroup (1C) at 1.0 ppm (of which no more than 0.50 ppm is TMS), and vegetable, root (except radish) subgroup (1A) at 0.15 ppm (of which no more than 0.10 ppm is TMS). This regulation increases tolerances in wheat, bran at 30 ppm (of which no more than 6.0 ppm is TMS), wheat, grain at 10 ppm (of which no more than 2.5 ppm is TMS), wheat, hay at 1.0 ppm (of which no more than 0.50 ppm is TMS), wheat, shorts at 20 ppm (of which no more than 5.0 ppm is TMS), wheat, straw at 90 ppm (of which no more than 40 ppm is TMS), and poultry meat by-products at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by sulfosate is discussed in Unit II.A. of the Federal Register document published on September 11, 1998 (63 FR 48597) (FRL-6026-6). Please note that this unit included a typographical error. In the discussion of the feeding carcinogenicity study in mice, “79” should have been “7.9” in the following phrase: “In addition, there was increased incidence of white matter degeneration in the lumbar region of the spinal cord (males only) (2, 3, 4, 4, 79% response, controls to high dose).” The nature of these toxic effects is also discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The toxicological endpoints for sulfosate are discussed in Unit II. B. of the Federal Register document published on September 11, 1998 (63 FR 48597).

A summary of the toxicological endpoints for sulfosate used for human risk assessment is shown in the following Table 2:

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.489) for the residues of sulfosate, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from sulfosate in food as follows:

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The Dietary Exposure Evaluation Model (DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: Tolerance level residues, DEEM default processing factors, and 100% crop treated (CT) information for all commodities. For acute dietary risk estimates, EPA's level of concern is for exposure at greater than 100% of the acute population adjusted dose (aPAD). The acute exposure estimates at the 95th percentile were < 100% of the aPAD for the general U.S. population and all subgroups, with children 1-6 years old as the highest exposure estimate at 55% of the aPAD. The results of the analysis indicate that the acute dietary risk estimates associated with the existing and proposed uses of sulfosate do not exceed EPA's level of concern for the general U.S. population and all population subgroups.

ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEMTM analysis evaluated the individual food consumption as reported by respondents in the USDA 1989-1992 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues for all commodities, DEEM default processing factors, and %CT information for some commodities (oranges, grapefruit, soybeans, corn, peaches, and wheat). This procedure represents an over-estimation of dietary exposure, since tolerance level residue values were used for all commodities. For chronic dietary risk estimates, EPA's level of concern is for exposure at greater than 100% chronic population adjusted dose (cPAD). The chronic exposure estimates were < 100% of the cPAD for the general U.S. population and all subgroups, with children 1-6 years old as the most highly exposed population subgroup at 60% of the cPAD. The results of the analysis indicate that the chronic dietary risk estimates associated with the existing and proposed uses of sulfosate do not exceed EPA's level of concern for the U.S. population and all population subgroups.

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, 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; condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and condition 3, 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 percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency used PCT information as follows.

For the acute analysis, tolerance level residues and 100% CT were used. For the chronic analysis, PCT information was used for oranges (1% CT), grapefruit (10% CT), soybeans (1% CT), corn (10% CT), peaches (1% CT), and wheat (1% CT). For corn, peaches, and wheat, which have PCT estimates of zero, a value of 1% CT was used in the analysis. For all crops other than oranges, grapefruit, soybeans, corn, peaches, and wheat, 100% CT was used, and tolerance level residues were used for all crops.

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, 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 regional consumption of food to which sulfosate may be applied in a particular area.

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

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

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

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

Based on the GENEEC and SCI-GROW model, EECs of total sulfosate for acute exposures are estimated to be 125.5 ppb for surface water and 0.328 ppb for ground water. The EECs for chronic exposures are estimated to be 27.8 ppb for surface water and 0.328 ppb for ground water.

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

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

4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) 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 sulfosate 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, sulfosate 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 sulfosate 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. Safety factor for infants and children—In general. FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans.

2. Prenatal and postnatal sensitivity. Prenatal and postnatal sensitivity is discussed in Unit II.E.1.iv. of the Federal Register document published on September 11, 1998 (63 FR 48597).

3. Conclusion. With the exception of the requested developmental neurotoxicity study, there is a complete toxicity data base for sulfosate and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The determination of the 3x safety factor for infants and children is discussed in Unit II.E.1.i. of the Federal Register document published on September 11, 1998 (63 FR 48597).

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

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

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to sulfosate will occupy 33% of the aPAD for the U.S. population, up to 18% of the aPAD for females 13 years and older, 50% of the aPAD for all infants (< 1 year old) and 55% of the aPAD for children 1-6 years old. In addition, there is potential for acute dietary exposure to sulfosate in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in the following Table 3:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to sulfosate from food will utilize 19% of the cPAD for the U.S. population, 47% of the cPAD for all infants (< 1 year old) and 60% of the cPAD for children 1-6 years old. There are no residential uses for sulfosate that result in chronic residential exposure to sulfosate. In addition, there is potential for chronic dietary exposure to sulfosate in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 4:

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

Analytical enforcement methodology for sulfosate is discussed in Unit III.B. of the Federal Register document published on September 11, 1998 (63 FR 48597).

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

There are no Codex, Canadian or Mexican tolerances or maximum residue limits for residues of sulfosate in the subject commodities. Therefore, a compatibility issue is not relevant to the proposed tolerances.

EPA is imposing requirements of the following studies as conditions of registration: A developmental neurotoxicity study (DNT) in the rat (OPPTS Guideline No. 870.6300) (previously imposed and in progress) and a 28-day inhalation toxicity study. The DNT study in the rat is required based on the weight-of-the-evidence concerns for neurotoxicity in the mouse oncogenicity study, the subchronic and chronic dog studies, the 21-day dermal toxicity study in rats, and acute and subchronic neurotoxicity studies in the rat. Signs of neurotoxicity due to sulfosate included function observational battery (FOB) effects in the rat neurotoxicity studies, and treatment-related chemical signs of salivation and emesis in the dog. There were also concerns for hydrocephalus in all dog studies (at least one dog/study at the high dose, none in controls) and possible treatment related histopathology in the mouse carcinogenicity and 21-day dermal rat studies. The 28-day inhalation toxicity study is required to provide further characterization of inhalation risk. Due to the potential for inhalation exposure, there is concern for toxicity by the inhalation route. The 28-day inhalation toxicity study would give a dose and endpoint examined via the route of exposure of concern (i.e., route specific study) and thus would avoid using an oral study and route-to-route extrapolation. The protocol for the existing 90-day inhalation toxicity study (OPPTS 870.3465) should be followed with the exposure (treatment) ending after 28 days, instead of 90 days.

Therefore, the tolerance is established for residues of sulfosate, sulfonium, trimethyl-salt with N-(phosphonomethyl)glycine (1:1), in or on cotton, gin by-products at 120 ppm (of which no more than 35 ppm is TMS), cotton, undelinted seed at 40 ppm (of which no more than 10 ppm is TMS), pea and bean, dried shelled except soybean), subgroup (6C) at 6.00 ppm (of which no more than 1.5 ppm is TMS), vegetable, legume, edible podded subgroup (6A) at 0.50 ppm (of which no more than 0.3 ppm is TMS), vegetable, fruiting group (8) at 0.05 ppm, sorghum, grain, forage at 0.20 ppm (of which no more than 0.10 ppm is TMS), sorghum, grain, grain at 35 ppm (of which no more than 15 ppm is TMS), sorghum, grain, stover at 140 ppm (of which no more than 60 ppm is TMS), vegetable, leaves of root and tuber (except radish) group (2) at 0.30 ppm (of which no more than 0.20 ppm is TMS), pistachio at 0.05 ppm, radish, roots at 16 ppm (of which no more than 15 ppm is TMS), radish, tops at 10 ppm (of which no more than 8.0 ppm is TMS), pea and bean, succulent shelled subgroup (6B) at 0.20 ppm (of which no more than 0.10 ppm is TMS), corn, sweet, forage at 20 ppm (of which no more than 5.0 ppm is TMS), corn, sweet, kernals plus cob with husks removed at 0.15 ppm (of which no more than 0.10 ppm is TMS), corn, sweet, stover at 170 ppm (of which no more than 65 ppm is TMS), vegetable, tuberous and corm subgroup (1C) at 1.0 ppm (of which no more than 0.50 ppm is TMS), and vegetable, root (except radish) subgroup (1A) at 0.15 ppm (of which no more than 0.10 ppm is TMS). This regulation increases tolerances in wheat, bran at 30 ppm (of which no more than 6.0 ppm is TMS), wheat, grain at 10 ppm (of which no more than 2.5 ppm is TMS), wheat, hay at 1.0 ppm (of which no more than 0.50 ppm is TMS), wheat, shorts at 20 ppm (of which no more than 5.0 ppm is TMS), wheat, straw at 90 ppm (of which no more than 40 ppm is TMS), and poultry meat by-products 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-301173 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 November 20, 2001.

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

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

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

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

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

3. Copies for the docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301173, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any 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). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

This final rule updates, streamlines, and clarifies FPMR part 101-46 and moves the part into the Federal Management Regulation (FMR). The rule is written in a plain language question and answer format. In this format, a question and its answer combine to establish a rule. This means the employee and the agency must follow the language contained in both the question and its answer.

Updates include:

1. A revised definition of “replacement.”

2. A new provision regarding the fixed price sale of exchange/sale property to a State Agency for Surplus Property before conducting an exchange/sale with a non-Government entity.

3. Revised restrictions on types of personal property that are ineligible for exchange/sale, including removal of large weapons, fire control equipment, and guided missiles belonging to the Department of Defense, and furniture belonging to any executive agency from the list of such property.

4. Clarified restrictions on the exchange/sale of combat material.

5. A revised requirement for documentation of exchange/sale transactions.

6. Revised accounting requirements for the proceeds from the sale of personal property under the exchange/sale authority.

7. A new annual reporting requirement for exchange/sale transactions.

GSA has determined that this final rule is not a significant rule for the purposes of Executive Order 12866 of September 30, 1993.

A regulatory flexibility analysis is not required under the Regulatory Flexibility Act, 5 U.S.C. 601. et seq., because there is no requirement that this final rule be published in the Federal Register for notice and comment.

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

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

For the reasons set forth in the preamble, GSA amends 41 CFR chapters 101 and 102 as follows:

Each year, title 46 of the Code of Federal Regulations (CFR) is recodified on October 1. This rule makes editorial changes throughout the title, corrects addresses, updates cross-references, and makes other technical and editorial corrections to be included in the recodification. This rule does not change any substantive requirements of existing regulations.

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. This rule consists only of corrections, editorial changes, and conforming amendments to 46 CFR, chapters I and III. These changes will have no substantive effect on the public so publishing an NPRM and providing an opportunity for public comment is unnecessary. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that, for the same reasons, good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Editorial changes that involve more than simply correcting erroneous letters or numbers—or a change of address—are discussed individually in the following paragraphs.

This rule adds the Director of Waterways Management (G-MW), to the Code of Federal Regulations, and it updates the distribution of functions assigned to several offices.

In these parts, this rule updates information on obtaining nautical charts and publications by inserting references to the National Imagery and Mapping Agency.

Since 1973, this section has referenced SOLAS 60. On July 26, 1990, a rulemaking titled “Replacement of References to SOLAS 60 With SOLAS 74” (55 FR 30658) was published to amend, among other things, this section and three other similar sections of title 46 (§§ 70.05-10, 90.05-10, and 188.05-10). All four amendatory instructions (# 11, 23, 32, and 68) were supposed to make the same change in the regulatory text of these four sections. They all should have read “Section * * * is amended by revising paragraphs (a)(2)(i) and (ii) to read as follows:”.

However, amendatory instruction # 11 in that rulemaking erroneously read “Section 30.01-6 is amended by revising paragraph (a) to read as follows:”. The instruction resulted in the deletion of paragraph (a)(2)(iii). This rule now corrects paragraph (a) by adding back the deleted language.

On September 30, 1997, a rulemaking titled “Harmonization With International Safety Standards” (62 FR 51188) was published to amend, among other things, subpart 32.53. The Coast Guard determined that applicable SOLAS provisions regarding inert gas systems were equivalent to current Coast Guard regulations in terms of safety and operating requirements. Therefore, the Coast Guard incorporated SOLAS Chapter II-2 Regulation 62, containing the SOLAS requirements for inert gas systems, by reference in subpart 32.53 and removed §§ 32.53-15 through 32.53-85, which duplicate SOLAS requirements. The result was that § 32.53-5 now incorrectly references § 32.53-30, which was removed. This rule removes the incorrect cross-reference.

This rule makes changes in these parts to reflect changes in the functional responsibilities for sections in these parts.

This rule removes and reserves an obsolete paragraph, 46 CFR 199.620(m), and deletes an obsolete reference in a table.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT)(44 FR 11040; February 26, 1979). We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. As this rule involves internal agency practices and procedures, it will not impose any costs on the public.

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, Federalism, 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) requires Federal agencies to assess the effects of their regulatory actions not specifically required by law. In particular, the Act addresses actions that may result in the expenditure of $100 million or more in any one year by a State, local, or tribal government, in the aggregate, or by the private sector. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

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.

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

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

We considered the environmental impact of this rule and concluded that, under figure 2-1, paragraph (34)(a) and (b) of Commandant Instruction M16475.lD, this rule is categorically excluded from further environmental documentation. This exclusion is in accordance with paragraphs (34)(a) and (b), concerning regulations that are editorial or procedural and concerning internal agency functions or organization. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES.