This rule is issued under Marketing Agreement No. 84 and Marketing Order No. 905, both as amended (7 CFR part 905), regulating the handling of oranges, grapefruit, tangerines, and tangelos grown in Florida, hereinafter referred to as the “order.” The order is 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 (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Florida citrus handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein is applicable to all assessable oranges, grapefruit, tangerines, and tangelos grown in Florida, beginning August 1, 2003, and continue until amended, suspended, or terminated. 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 USDA 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. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA 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 USDA'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 increases the assessment rate established for the Committee for the 2003-04 and subsequent fiscal periods from $0.005 per 4/5 bushel carton to $0.006 per 4/5 bushel carton of oranges, grapefruit, tangerines, and tangelos grown in Florida.

The Florida citrus marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of oranges, grapefruit, tangerines, and tangelos. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2001-02 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on July 1, 2003, and unanimously recommended 2003-04 expenditures of $247,000 and an assessment rate of $0.006 per 4/5 bushel of oranges, grapefruit, tangerines, and tangelos grown in Florida based on a crop estimate of 45 million 4/5 bushels. In comparison, last year's budgeted expenditures were $250,700. The assessment rate of $0.006 is $0.001 higher than the $0.005 rate previously in effect. This increase reflects the Committee's expectation of lower shipments in the coming year resulting in less assessment income to cover expenses. In addition, the Committee wants to increase the monies available in their reserve fund.

The major expenditures recommended by the Committee for the 2003-04 fiscal year include $126,000 for salaries, $25,000 for Manifests-USDA-FDACS, $21,000 for insurance and bonds, $19,500 for retirement plan, and $10,100 for payroll taxes. Budgeted expenses for these items in 2002-03 were $126,000, $25,000, $21,000, $19,500, and $10,100, respectively.

The assessment rate recommended by the Committee was derived by dividing anticipated expenses by expected shipments of oranges, grapefruit, tangerines, and tangelos. As mentioned earlier, Florida citrus shipments for the year are estimated at 45 million 4/5 bushels, which should provide $270,000 in assessment income. Income derived from handler assessments, along with interest income and funds from the Committee's authorized reserve, will be adequate to cover budgeted expenses. Funds in the reserve currently total approximately $23,091 and are within the maximum permitted by the order of not to exceed one half of one fiscal period's expenses as stated in § 905.42(a).

The assessment rate established in this rule continues in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate is in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2003-04 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule 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 the 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 11,000 producers of oranges, grapefruit, tangerines, and tangelos in the production area and approximately 75 handlers 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 industry and Committee data, the average annual f.o.b. price for fresh Florida oranges, grapefruit, tangerines, and tangelos during the 2002-03 season was approximately $8.55 per 4/5 bushel carton, and total fresh shipments for the 2003-04 season are estimated at 45 million cartons of oranges, grapefruit, tangerines, and tangelos. Approximately 20 handlers handled 65 percent of Florida's citrus shipments in 2002-03. Considering the average f.o.b. price, at least 55 percent of the orange, grapefruit, tangerine, and tangelo handlers could be considered small businesses under SBA's definition. Therefore, the majority of Florida citrus handlers may be classified as small entities. The majority of Florida citrus producers may also be classified as small entities.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2003-04 and subsequent fiscal periods from $0.005 to $0.006 per 4/5 bushel carton of oranges, grapefruit, tangerines, and tangelos. The Committee unanimously recommended 2003-04 expenditures of $247,000 and an assessment rate of $0.006 per 4/5 bushel carton. The assessment rate of $0.006 is $0.001 higher than the current rate. The quantity of assessable oranges, grapefruit, tangerines, and tangelos for the 2003-04 season is estimated at 45 million 4/5 bushel cartons. Thus, the $0.006 rate should provide $270,000 in assessment income and be adequate to meet this year's expenses.

The major expenditures recommended by the Committee for the 2003-04 fiscal period include $126,000 for salaries, $25,000 for Manifests-USDA-FDACS, $21,000 for insurance and bonds, $19,500 for retirement plan, and $10,100 for payroll taxes. Budgeted expenses for these items in 2002-03 were $126,000, $25,000, $21,000, $19,500, and $10,100, respectively.

The increase in the assessment rate is due to the Committee's expectation that shipments in the coming year will be lower affecting assessment income. The Committee also wants to replenish its reserve fund.

The Committee reviewed and unanimously recommended 2003-04 expenditures of $247,000. Prior to arriving at this budget, the Committee considered information from various sources including the Committee's Budget Subcommittee. Alternative assessment rates were discussed based on different estimates of assessable cartons and budget expenses. The assessment rate of $0.006 per 4/5 bushel carton of assessable oranges, grapefruit, tangerines, and tangelos was then determined by dividing the total recommended budget by the quantity of assessable commodity, estimated at 45 million 4/5 bushel cartons for the 2003-04 season taking into consideration the need for additional funds to increase reserves. This assessment rate will yield approximately $23,000 over anticipated budgeted expenses with the excess funds to be earmarked for the reserve fund.

A review of historical information and preliminary information pertaining to the upcoming 2003-04 fiscal period indicates that the grower price for the 2003-04 season could range between $1.80 and $20.40 per 4/5 bushel of oranges, grapefruit, tangerines, and tangelos. Therefore, the estimated assessment revenue for the 2003-04 fiscal period as a percentage of total grower revenue could range between .03 and .33 percent.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. Some of the additional costs may be passed on to producers. However, these costs are offset by the benefits derived by the operation of the marketing order.

In addition, the Committee's meeting was widely publicized throughout the Florida citrus industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the July 1, 2003, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

This rule imposes no additional reporting or recordkeeping requirements on either small or large Florida citrus 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.

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

A proposed rule concerning this action was published in the Federal Register on July 28, 2003 (68 FR 44237). Copies of the proposed rule were also mailed or sent via facsimile to all Florida citrus handlers. Finally, the proposal was made available through the Internet by the Office of the Federal Register and USDA. A 30-day comment period ending August 27, 2003, was provided for interested persons to respond to the proposal. No comments were 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 material presented, including the information and recommendation submitted by the Committee 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.

Pursuant to 5 U.S.C. 553, it also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The 2003-04 fiscal period began August 1, 2003, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable citrus fruit handled during such fiscal period; (2) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis; and (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment actions issued in past years.

This rule is issued under Marketing Agreement and Order No. 987, both as amended (7 CFR part 987), regulating the handling of domestic dates produced or packed in Riverside County, California, 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 (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California date handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable dates beginning on October 1, 2003, and continue until amended, suspended, or terminated. 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 USDA 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. Such handler is afforded the opportunity for a hearing on the petition. After the hearing USDA 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 USDA'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 decreases the assessment rate established for the Committee for the 2003-04 and subsequent crop years from $0.90 to $0.75 per hundredweight of assessable dates handled.

The California date marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and producer-handlers of California dates. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed at a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2002-03 and subsequent crop years, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from crop year to crop year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on June 20, 2003, and unanimously recommended 2003-04 expenditures of $225,365 and an assessment rate of $0.75 per hundredweight of dates handled. In comparison, last year's budgeted expenditures were $273,450. The recommended assessment rate of $0.75 is $0.15 lower than the rate currently in effect. The decrease in the assessment rate and budget is primarily due to a lower marketing and promotion budget.

Proceeds from the sales of cull dates are usually deposited in a surplus account for subsequent use by the Committee in covering the surplus pool share of the Committee's expenses. Handlers may also dispose of cull dates of their own production within their own livestock-feeding operation; otherwise, such cull dates must be shipped or delivered to the Committee for sale to non-human food product outlets.

Last year, the Committee applied $5,000 of surplus account monies to cover surplus pool expenses. Based on a recent trend of declining sales of cull dates over the past few years and reduced surplus pool costs, the Committee decided not to apply any of the surplus pool funds toward the 2003-04 Committee budget. The Committee, instead, recommended assessing handlers $0.75 per hundredweight and using $30,365 from the administrative reserves to fund the reduced Committee budget of $225,365.

The budgeted administrative expenses for the 2003-04 crop year include $123,710 for labor and office expenses. This compares to $123,450 in budgeted expenses in 2002-03. In addition, $101,655 has been budgeted for marketing and promotion under the program for the 2003-04 crop year. This compares to $150,000 in budgeted marketing and promotion expenses for the 2002-03 crop year.

The assessment rate of $0.75 per hundredweight of assessable dates was derived by applying the following formula where:

Estimated shipments should provide $195,000 in assessment income. Income derived from handler assessments and the administrative reserves will be adequate to cover budgeted expenses. Funds in the reserve on September 30, 2004, are expected to be less than the maximum permitted by the order (not to exceed 50 percent of the average of expenses incurred during the most recent five preceding crop years; § 987.72(c)).

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each crop year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2003-04 budget and those for subsequent crop years will be reviewed and, as appropriate, approved by USDA.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule 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 the 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 100 producers of dates in the production area and approximately 10 handlers 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 of less than $750,000, and small agricultural service firms are defined as those having annual receipts of less than $5,000,000. Five of the 10 handlers (50 percent) shipped over $5,000,000 of dates and could be considered large handlers by the Small Business Administration. Five of the 10 handlers (50 percent) shipped under $5,000,000 of dates and could be considered small handlers. The majority of California date producers may be classified as small entities.

This rule decreases the assessment rate established for the Committee and collected from handlers for the 2003-04 and subsequent crop years from $0.90 to $0.75 per hundredweight of assessable dates handled. The Committee unanimously recommended 2003-04 expenditures of $225,365 and the $0.75 per hundredweight assessment rate. The assessment rate of $0.75 is $0.15 lower than the rate currently in effect. The quantity of assessable dates for the 2003-04 crop year is estimated at 260,000 hundredweight. Thus, the $0.75 per hundredweight rate should provide $195,000 in assessment income. This along with administrative reserve funds should be adequate to meet the Committee's 2003-04 crop year expenses.

The budgeted administrative expenses for the 2003-04 crop year include $123,710 for labor and office expenses. This compares to $123,450 in budgeted expenses in 2002-03. In addition, $101,655 has been budgeted for marketing and promotion under the marketing order for the 2003-04 crop year. This compares to $150,000 in budgeted marketing and promotion expenses for the 2002-03 crop year.

The Committee reviewed and unanimously recommended 2003-04 expenditures of $225,365 which include marketing and promotion programs. Prior to arriving at this budget, the Committee considered alternative expenditure levels, including a proposal to not have a budget. The assessment rate of $0.75 per hundredweight of assessable dates was then determined by applying the following formula where:

Estimated shipments should provide $195,000 in assessment income. Income derived from handler assessments and the administrative reserves will be adequate to cover budgeted expenses. Funds in the administrative reserve on September 30, 2004, are expected to be less than the maximum permitted by the order (not to exceed 50 percent of the average of expenses incurred during the most recent five preceding crop years; § 987.72(c)).

A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the grower price for the 2003-04 season could range between $40 and $120 per hundredweight of dates. Therefore, the estimated assessment revenue for the 2003-04 crop year as a percentage of total grower revenue could range between .6 and 2 percent.

This action decreases the assessment obligation imposed on handlers under the Federal marketing order. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers, and may reduce the burden on producers. In addition, the Committee's meeting was widely publicized throughout the California date industry, and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 20, 2003, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

This rule imposes no additional reporting or recordkeeping requirements on either small or large California date 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.

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

A proposed rule concerning this action was published in the Federal Register on July 28, 2003 (68 FR 44241). Copies of the proposed rule were also mailed or sent via facsimile to all date handlers. Finally, the proposal was made available through the Internet by the Office of the Federal Register and USDA. A 30-day comment period ending August 27, 2003, was provided for interested persons to respond to the proposal. No comments were 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 material presented, including the information and recommendation submitted by the Committee 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.

Pursuant to 5 U.S.C. 553, it also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because handlers will soon be receiving 2003-04 crop dates from growers. In addition, the crop year begins on October 1, 2003, and the assessment rate applies to all assessable dates during the 2003-04 and subsequent seasons. Further, handlers are aware of this rule which was recommended at a public meeting. Also, a 30-day comment period was provided for in the proposed rule and no comments were received.

A final rule AD, FR Doc. 03-18078, applicable to Rolls-Royce plc (RR) RB211-524G2, -524G2-T, -524G3, -524G3-T, -524H, -524H-T, -524H2, and -524H2-T series, and models RB211 Trent 768-60, 772-60, and 772B-60 turbofan engines, was published in the Federal Register on July 17, 2003 (68 FR 42242). The following correction is needed:

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 95-14-09, amendment 39-9303 (60 FR 36984, July 19, 1995), which is applicable to certain Learjet Model 60 airplanes, was published in the Federal Register on June 18, 2003 (68 FR 36502). That action proposed to require inspection to detect bends in or damage to the fuel crossflow tube; inspection to determine clearance between the fuel crossflow tube and the flight control cables; and replacement or repair of the tube, if necessary. That action also proposed to require a review of airplane maintenance records or an inspection to determine if a fuel crossflow tube having a certain part number is installed; and follow-on/corrective actions, as applicable. That action also proposed to expand the applicability of the existing AD to include additional airplanes.

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

In paragraph (a) of the proposed rule, we inadvertently specified an incorrect part number. We have revised this AD to specify the correct part number.

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

We have reviewed the figures we have used over the past several years to calculate AD costs to operators. To account for various inflationary costs in the airline industry, we find it necessary to increase the labor rate used in these calculations from $60 per work hour to $65 per work hour. The cost impact information, below, reflects this increase in the specified hourly labor rate.

There are approximately 145 airplanes of the affected design in the worldwide fleet. The FAA estimates that 109 airplanes of U.S. registry will be affected by this AD.

It will take approximately 2 work hours per airplane to accomplish the review of airplane maintenance records/inspection required in this AD action, at an average labor rate of $65 per work hour. Based on these figures, the cost impact of the requirements of this AD on U.S. operators is estimated to be $14,170, or $130 per airplane.

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

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

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

On August 6, 2003, the FAA issued AD 2003-16-15, amendment 39-13268 (68 FR 49340, August 18, 2003), applicable to certain Airbus Model A300 B4-600, B4-600R, and F4-600R (collectively called A300-600) series airplanes, and Airbus Model A310 series airplanes. That AD requires replacement of Honeywell inertial reference units (IRU) with new or modified Honeywell IRUs. For certain airplanes, that AD also requires replacement of Litton IRUs, mode selector units (MSU), and an inertial sensor display unit (ISDU) with new Honeywell IRUs, MSUs, and a new ISDU. That action was prompted by notification from the Direction Geéneérale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, that an operator reported loss of positioning data and the display of incorrect attitude data shortly after take-off because the airplane was moved on the ground before the IRU alignment procedure had been completed. The actions required by that AD are intended to prevent loss of positioning data and a display of incorrect attitude data.

It should be noted that the FAA previously issued AD 2001-13-24, amendment 39-12306 (66 FR 35532, July 6, 2001), applicable to certain Airbus Model A300-600 and A310 series airplanes. The DGAC notified the FAA that an unsafe condition may exist on certain Airbus Model A310 series airplanes and certain Airbus Model A300-600 series airplanes with certain Honeywell IRUs. The DGAC advised that an operator reported the loss of positioning data and the display of incorrect attitude data shortly after take-off, because the aircraft had been moved on the ground before the end of the IRU alignment procedure. This condition, if not corrected, could result in the loss of positioning data and a display of incorrect attitude data, which could compromise the ability of the flightcrew to maintain the safe flight and landing of the airplane. AD 2001-13-24 requires revisions to the Normal Procedures section of the airplane flight manual to prohibit movement of the airplane during IRU alignment and to provide instructions to the flightcrew to check the navigational display system to ensure correct display of all primary attitude and heading information prior to flight. That action is intended to address the identified unsafe condition.

Since the issuance of AD 2003-16-15, we reviewed the requirements of that AD and noted incorrect information concerning the removal and replacement of certain Litton IRU equipment. The applicability section of AD 2003-16-15 states that that AD is applicable to certain Airbus Model A300-600 and A310 series airplanes equipped with certain Honeywell IRU part numbers. Therefore, Airbus Model A300-600 and A310 series airplanes equipped with Litton IRUs are not subject to the requirements of AD 2003-16-15.

The procedures for performing the actions required by AD 2003-16-15 are stated in Airbus Service Bulletins A300-34-6135, Revision 01 (for Model A300-600 series airplanes); and A310-34-2158, Revision 01 (for Model A310 series airplanes); both dated September 10, 2001. These service bulletins describe procedures for replacement of Honeywell IRUs with new or modified Honeywell IRUs, and were identified as mandatory service bulletins in French airworthiness directive 2001-303(B), dated July 25, 2001. Airbus Service Bulletins A300-34-6135, Revision 01; and A310-34-2158, Revision 01; specify prior or concurrent accomplishment of Airbus Service Bulletins A300-34-6082, Revision 05, dated February 13, 1998; and A310-34-2104, dated May 12, 1995; as applicable. Service Bulletins A300-34-6082 and A310-34-2104 both include provisions for those operators who have previously replaced Litton IRUs with Honeywell IRUs. For several specific aircraft these service bulletins specify the replacement of Litton IRUs with Honeywell IRUs as required changes associated with mandatory service bulletins. As a result, the replacement of certain Litton IRUs with certain Honeywell IRUs was incorrectly identified as a requirement in paragraphs (c) and (d) of AD 2003-16-15.

Therefore, one of the purposes of this AD is to remove that requirement to replace certain Litton IRUs with certain Honeywell IRUs. The Litton IRUs are designed to provide clear indication to the flightcrew if the aircraft has been moved during IRU alignment, and are not subject to the unsafe condition addressed in AD 2003-16-15.

In addition, we have removed paragraph (e), Parts Installation, of AD 2003-16-15, which prohibits the installation of certain Litton and Honeywell IRU part numbers. As stated previously, the Litton IRUs are not subject to the unsafe condition addressed by this AD. Paragraph (e)(1) of AD 2003-16-15 requires that, as of September 22, 2003 (the effective date of that AD), operators no longer install Honeywell IRUs having part numbers HG1050BD02 and HG1050BD05. The actions required by AD 2003-15-16 are specified in Airbus Service Bulletins A300-34-6135, Revision 01; and A310-34-2158, Revision 01; both dated September 10, 2001. These bulletins state that “it is impossible to mix old P/Ns with new P/Ns.” Therefore it is necessary for the operators to replace or modify all three IRUs installed on each aircraft simultaneously. It is the understanding of the FAA that operators often only stock one spare unit in each field spares location. In order to adequately prepare for the possibility of IRU failures in the field after the effective date of that AD, each operator would have to replace their current spare IRUs with three updated IRUs, thus increasing their allotment of spares threefold. It is unlikely that Honeywell will be able to distribute the necessary number of IRUs to the operators' field spares locations prior to the effective date of this AD. It is likely that delay of delivery of these replacement IRUs would result in flight delays and/or cancellations. Continued compliance with AD 2001-13-24, described previously, provides adequate assurance that safety will not be compromised by continued use of the subject Honeywell IRUs until the parts replacement requirements of this AD are accomplished. Therefore, we have determined that a Parts Installation paragraph is not required in this AD.

In light of the above, we have determined that it is necessary to issue this supersedure AD to ensure the continued operational safety of the fleet.

These airplane models are manufactured in France and are type-certificated for operation in the United States under the provisions of § 21.29 of the Federal Aviation Regulations (14 CFR 21.29) and the applicable bilateral airworthiness agreement.

Since an unsafe condition has been identified that is likely to exist or develop on other airplanes of the same type design registered in the United States, this AD supersedes AD 2003-16-15 to continue to require replacement of Honeywell IRUs with new or modified Honeywell IRUs. This AD removes all references to the replacement of Litton IRUs, MSUs, and a new ISDU with Honeywell IRUs, MSUs, and a new ISDU. This AD also removes paragraph (e), Parts Installation, of AD 2003-16-15, and allows the use of certain Honeywell IRUs as spare parts until the final compliance date of this AD. The actions are required to be accomplished in accordance with Airbus Service Bulletin A300-34-6135, Revision 01 (for Model A300-600 series airplanes); and Airbus Service Bulletin A310-34-2158, Revision 01 (for Model A310 series airplanes); both dated September 10, 2001.

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 2003-NM-206-AD.” The postcard will be date stamped and returned to the commenter.

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

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

On Wednesday, June 4, 2003, the FAA proposed to amend 14 CFR part 71 to modify Class E airspace at Cheboygan, MI (68 FR 33426). The proposal was to modify controlled airspace extending upward from 700 feet above the surface of the earth to contain Instrument Flight Rules (IFR) operations in controlled airspace during portions of the terminal operation and while transiting between the enroute and terminal environments.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005, of FAA Order 7400.9K dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the order.

This amendment to 14 CFR part 71 modifies Class E airspace at Cheboygan, MI, to accommodate aircraft executing instrument flight procedures into and out of Cheboygan County Airport. The area will be depicted on appropriate aeronautical charts.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore this, proposed regulation—(1) is not a “significant regulatory action” under Executive order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

On Wednesday, June 4, 2003, the FAA proposed to amend 14 CFR part 71 to modify Class E airspace at West Union, OH (68 FR 33427). The proposal was to modify controlled airspace extending upward from 700 feet above the surface of the earth to contain Instrument Flight Rules (IFR) operations in controlled airspace during portions of the terminal operation and while transiting between the enroute and terminal environments.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005, of FAA Order 7400.9K dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the order.

This amendment to 14 CFR part 71 modifies Class E airspace at West Union, OH, to accommodate aircraft executing instrument flight procedures into and out of Alexander Salamon Airport. The area will be depicted on appropriate aeronautical charts.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); (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.

On Monday, April 21, 2003, the FAA proposed to amend 14 CFR part 71 to modify Class E airspace at South Bend, IN (68 FR 19470). The proposal was to modify controlled airspace extending upward from 700 feet above the surface of the earth to contain Instrument Flight Rules (IFR) operations in controlled airspace during portions of the terminal operation and white transiting between the en route and terminal environments.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No comments objecting to the proposal were received. Class E airspace areas extending upward from 700 feet or more above the surface of the earth are published in paragraph 6005, of FAA Order 7400.9K dated August 30, 2002, and effective September 16, 2002, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the order.

This amendment to 14 CFR part 71 modifies Class E airspace at South Bend, IN, to accommodate aircraft executing instrument flight procedures into and out of South Bend Regional Airport. The area will be depicted on appropriate aeronautical charts.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore this, proposed regulation—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Airspace Docket No. 02-ANM-16, published August 12, 2003 (68 FR 47844), corrected an error in the coordinates of the east boundary description of the Class E airspace at Richfield Municipal Airport, Richfield, UT. This action corrects another geographic coordinate to the Class E Airspace at Richfield Municipal Airport, Richfield, UT. This action also corrects the effective date back to September 4, 2003.

On July 30, 2001, the FAA issued Repair Stations; Final Rule with Request for Comments and Direct Final Rule with Request for Comments (66 FR 41088; August 6, 2001). That final rule updates and revises part 145 of Title 14, Code of Federal Regulations, which prescribes the regulations for aeronautical repair stations. In that rulemaking action, we established a new requirement that each repair station must maintain and use a current repair station manual and a quality control manual. We also prescribed the contents of these manuals.

Initially, the final rule was to become effective April 6, 2003. However, on October 21, 2002, the FAA received a petition from the Aircraft Electronics Association, the Aerospace Industries Association, the Aviation Suppliers Association, and the National Air Transportation Association. Those petitioners requested that the FAA extend the effective date of the final rule arguing that we had not yet published advisory material and guidance explaining how to produce an acceptable manual. Further, the petitioners asserted that without advisory material, we could not adequately train FAA personnel. We agreed with the petitioners and extended the effective date of the final rule to October 3, 2003 (68 FR 125429, March 14, 2003; 68 FR 17545, April 10, 2003).

On July 3, 2003, the FAA issued Advisory Circular No. 145-9 (AC 145-9), Guide for Developing and Evaluating Repair Station and Quality Control Manuals. That document provides information and guidance material for developing and evaluating repair station manuals and quality control manuals. The material describes an acceptable means, but not the only means, to develop a manual and comply with the rules contained in part 145. Interested parties may access AC 145-9 at the following Internet Web site: http://www.airweb.faa.gov/Regulatory_and_Guidance_Library/rgWebcomponents.nsf/HomeFrame?OpenFrameSet.

On July 22, 2003, the Aircraft Electronics Association, the Aviation Repair Station Association, and the National Air Transportation Association submitted another petition requesting that the FAA further extend the effective date of the final rule. The petitioners note that the FAA issued material to guide repair stations in developing the manuals required in part 145 only 90 days before the effective date of the rule. The petitioners contend that 90 days is not enough time to develop manuals using the guidance materials. Therefore, the petitioners request that we extend the effective date of the final rule an additional 120 days.

We agree with the petitioners that additional time is necessary to allow repair station certificate holders to prepare repair station manuals and quality control manuals following the guidance provided in AC 145-9. Therefore, we find that a 120-day extension is in the public interest.

The petitioners also note that § 145.221 references sections in 14 CFR parts 121, 125, and 135 related to service difficulty reporting, which have not become effective. The FAA is addressing this issue in a separate rulemaking action.

Finally, the delay in the effective date of the final rule does not impose any new requirements or any additional burden on the regulated public. However, the 120-day extension will delay realization of some cost savings provided by the rule. We, therefore, find there are no additional costs, aside from the delay in realizing some cost savings, or benefits associated with this action.

In accordance with 5 U.S.C. 553(b)(3)(B), I find good cause for issuing this rule without prior notice and comment. Seeking public comment is impracticable, unnecessary, and contrary to the public interest. This delay of effective date will give repair stations sufficient time to use FAA guidance material in preparing to operate under the amended regulations for repair stations. Given the imminence of the effective date, seeking prior public comments on this temporary delay would be impracticable, as well as contrary to the public interest in the orderly promulgation and implementation of this rule.

In consideration of the foregoing, parts 91, 121, 135, and 145 are amended to delay the effective date of the final rule by 120 days.

The Rule was issued by the Commission in 1979, 44 FR 66466 (Nov. 19, 1979), in response to a directive in the Energy Policy and Conservation Act of 1975 (“EPCA”). 1 The Rule covers several categories of major household appliances including dishwashers.

The Rule requires manufacturers of all covered appliances to disclose specific energy consumption or efficiency information (derived from the DOE test procedures) at the point of sale in the form of an “EnergyGuide” label and in catalogs. The Rule requires manufacturers to include, on labels and fact sheets, an energy consumption or efficiency figure and a “range of comparability.” This range shows the highest and lowest energy consumption or efficiencies for all comparable appliance models so consumers can compare the energy consumption or efficiency of other models (perhaps competing brands) similar to the labeled model. The Rule also requires manufacturers to include, on labels for some products, a secondary energy usage disclosure in the form of an estimated annual operating cost based on a specified DOE national average cost for the fuel the appliance uses.

On August 29, 2003, DOE published amendments to the test procedure manufacturers must use to determine the energy use of their dishwashers (68 FR 51887). The DOE amendments provide a new test procedure for testing the energy consumption of soil-sensing models, requires that manufacturers include the measurement of standby power consumption in cost and energy use for all dishwashers, and add new specifications for instrumentation requirements. Manufacturers may begin using this amended test procedure on September 29, 2003 and must use it for energy representations by February 25, 2004. 2 The amended DOE test procedure also changes the number of annual cycles used to estimate the energy consumption of a dishwasher in one year. The amendments reduce that number from 264 to 215 cycles per year (correlating to about 4 washloads per week).

Heska Corp., 1825 Sharp Point Dr., Fort Collins, CO 80525, filed ANADA 200-338 that provides for veterinary prescription use of TRI-HEART PLUS (ivermectin and pyrantel pamoate) Chewable Tablets for prevention of canine heartworm disease caused by Dirofilaria immitis and for treatment and control of ascarids ( Toxocara canis , Toxascaris leonina ) and hookworms ( Ancylostoma caninum , A. braziliense , and Uncinaria stenocephala ) in dogs. Heska Corp.'s TRI-HEART PLUS Chewable Tablets is approved as a generic copy of Merial's HEARTGARD Plus Chewables, approved under NADA 140-971. ANADA 200-338 is approved as of August 13, 2003, and 21 CFR 520.1196 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In addition, Heska Corp. is not currently listed in the animal drug regulations as a sponsor of an approved application. At this time, 21 CFR 510.600(c) is being amended to add entries for the firm.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Delmarva Laboratories, Inc., 1500 Huguenot Rd., suite 106, Midlothian, VA 23113, has informed FDA that it has transferred ownership of, and all rights and interest in, the following two approved NADAs and three approved ANADAs to Virbac AH, Inc., 3200 Meacham Blvd., Ft. Worth, TX 76137:

First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-352 for PRIMEX CANINE (pyrantel pamoate) and PRIMEX CANINE-2X (pyrantel pamoate). PRIMEX CANINE contains 2.27 milligrams (mg) pyrantel base per milliliter (/mL); PRIMEX CANINE-2X contains 4.54 mg pyrantel base/mL. Both products are for oral use in dogs and puppies for the removal of large roundworms ( Toxocara canis and Toxascaris leonina ) and hookworms ( Ancylostoma caninum and Uncinaria stenocephala ); and in dogs, puppies, and lactating bitches to prevent reinfections of T. canis . First Priority's PRIMEX CANINE and PRIMEX CANINE-2X are approved as generic copies of Pfizer, Inc.'s RFD Suspension and NEMEX-2 Suspension, respectively, approved under NADA 100-237. ANADA 200-352 is approved as of August 20, 2003, and the regulations are amended in § 520.2043 (21 CFR 520.2043) to reflect the approval. The basis of approval is discussed in the freedom of information summary. In addition, § 520.2043 is being amended to correct the spelling of one of the subject parasites.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

FDA has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to congressional review requirements in 5 U.S.C. 801-808.

First Priority, Inc., 1585 Todd Farm Dr., Elgin, IL 60123, filed ANADA 200-304 for PRITOX, a solution of copper naphthenate for topical application on horses and ponies as an aid in treating thrush caused by organisms susceptible to copper naphthenate. First Priority's PRITOX is approved as a generic copy of Ft. Dodge Animal Health's KOPERTOX, approved under NADA 12-991. The ANADA is approved as of July 25, 2003, and 21 CFR 524.463 is amended to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(1) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed ANADA 200-354 for use of PENNCHLOR (chlortetracycline) and COBAN (monensin) Type A medicated articles to make two-way combination drug Type C medicated feeds for broiler chickens. Pennfield Oil Co.'s ANADA 200-354 is approved as a generic copy of Alpharma, Inc.'s NADA 121-553 for combination use of AUREOMYCIN (chlortetracycline) and COBAN. The ANADA is approved as of August 15, 2003, and the regulations are amended in 21 CFR 558.355 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

In accordance with the freedom of information provisions of 21 CFR part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and effectiveness data and information submitted to support approval of this application may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

The agency has determined under 21 CFR 25.33(a)(2) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808.

On July 1, 2003, we published a temporary interim rule with request for comments and notice of public meeting titled “Automatic Identification System; Vessel Carriage Requirement” in the Federal Register (68 FR 39353). This temporary interim rule was one of a series of temporary interim rules on maritime security published in the July 1, 2003, issue of the Federal Register . On July 16, 2003, we published a document correcting typographical errors and omissions in that rule (68 FR 41913). The temporary interim rule established an Automatic Identification System (AIS) compliance date that varies depending upon VTS area. They are as follows:

(1) For VTS St. Marys River, not later than December 31, 2003;

(2) For VTS Berwick Bay, VMRS Los Angeles/Long Beach, VTS Lower Mississippi River, VTS Port Arthur and VTS Prince William Sound, not later than July 1, 2004; and

(3) For VTS Houston-Galveston, VTS New York, VTS Puget Sound, and VTS San Francisco, not later than December 31, 2004.

These deadline dates were established to coincide with anticipated AIS-capability at each of these respective ports via our Ports and Waterways Safety System (PAWSS) upgrades. PAWSS is an effort to establish a national transportation system that collects, processes, and disseminates information on the marine operating environment and maritime vessel traffic in major U.S. ports and waterways. Work continues on schedule in our PAWSS process; however, we recognize that having differing deadline dates has caused unwarranted confusion and may place certain vessels at a disadvantage of reaping market benefits. Therefore, the Coast Guard will amend its temporary interim rule, by a forthcoming final rule, that will adopt December 31, 2004, as the compliance date for all VTS users, not on international voyage, that are subject to the provisions of 33 CFR 164.46(b).

Until the Coast Guard publishes its final rule regarding AIS carriage requirements, the following policy applies:

The Coast Guard will not enforce the deadline dates as stated in 33 CFR 164.46(c)(1) through (4).

This policy will remain in effect until publication of the final rule regarding AIS carriage [USCG 2003-14757], that we anticipate publishing prior to October 25, 2003. In the final rule we intend to adopt December 31, 2004, as the deadline date for domestic AIS carriage for those vessels denoted in 33 CFR 164.46(b).

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0303. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

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

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

In the Federal Register of August 20, 2003 (68 FR 50138) (FRL-7321-7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP 2E6483 and 3E6558) by IR-4, 681 US Highway #1 South, New Brunswick, NJ 08902-3390. That notice included a summary of the petitions prepared by BASF Corporation, the registrant.

The petitions requested that 40 CFR 180.493 be amended by establishing tolerances for residues of the fungicide, dimethomorph,( E , Z ) 4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)-1-oxo-2-propenyl]morpholine in or on the following commodities: Brassica, leafy greens, subgroup 5B at 20.0 part per million (ppm); taro, corm at 0.5 ppm; taro, leaves at 6.0 ppm; and vegetable, fruiting, group 8 at 2.0 ppm. The tolerance petition for vegetable, fruiting, group 8 was subsequently amended to propose the tolerance at 1.5 ppm. EPA is also deleting tolerances for tomato, fruit at 0.5 ppm, and tomato, paste at 1.0 ppm established under section 180.493 (a). These commodities will be covered by the tolerance for vegetable, fruiting, group 8 at 1.5 ppm. There were no comments received on these petitions.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for tolerances for residues of dimethomorph on brassica, leafy greens, subgroup 5B at 20.0 ppm; taro, corm at 0.5 ppm; taro, leaves at 6.0 ppm; and vegetable, fruiting, group 8 at 1.5 ppm. EPA's assessment of exposures and risks associated with establishing the tolerances follow.

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 dimethomorph are discussed in the Federal Register of September 27, 2002 (67 FR 60916) (FRL-7199-2).

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 factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

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

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

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.493) for the residues of dimethomorph, in or on [grape; grape, raisin; hop, dried cones; lettuce, head; lettuce, leaf; potato, wet peel; tomato; tomato, paste; vegetable, bulb, group 3; and vegetable, cucurbit, group 9. Time-limited tolerances are also established for residues of dimethomorph in connection with use of the pesticide under emergency exemptions pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act for cantaloupe, cucumber, squash, and watermelon at 1.0 ppm set to expire on December 31, 2003. Additionally, time-limited tolerances are established for inadvertent or indirect residues of dimethomorph in or on the following raw agricultural commodities when present therein as a result of the application of dimethomorph to growing crops: grain, cereal group, fodder; grain, cereal group, forage; grain, cereal group, grain; grain, cereal group, hay; and grain, cereal group, straw at 0.15 ppm, set to expire on May 12, 2004. Risk assessments were conducted by EPA to assess dietary exposures from dimethomorph in food as follows:

i. Acute exposure . A quantitative acute dietary exposure and risk assessment was not conducted for dimethomorph since an acute oral endpoint attributed to a single-dose exposure could not be identified in any of the toxicology studies, including developmental and maternal toxicity in the developmental toxicity studies. No acute risk is expected from exposure to dimethomorph.

ii. Chronic exposure . In conducting this acute dietary risk assessment EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM TM /FCID) which incorporates food consumption data as reported by respondents in the United States Department of Agriculture (USDA) 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions was made for the chronic exposure assessment: The chronic dietary risk assessment for dimethomorph assumed tolerance level residues and 100% crop treated (Tier 1) for all registered and proposed crops.

iii. Cancer . EPA has classified dimethomorph as a “not likely” human carcinogen. Therefore, a quantitative cancer dietary exposure and risk assessment 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 dimethomorph 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 dimethomorph.

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

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

Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations (EECs) from these models to quantify drinking water exposure and risk as a %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. ince DWLOCs address total aggregate exposure to dimethomorph they are further discussed in the aggregate risk sections in Unit E.

Based on the GENEEC and SCI-GROW models the EECs of dimethomorph for acute exposures are estimated to be 79.8 parts per billion (ppb) for surface water and 0.30 ppb for ground water. The EECs for chronic exposures are estimated to be 28.5 ppb for surface water and 0.30 ppb for ground water.

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 screen for sorting out pesticides for which it is unlikely that drinking water concentrations would 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 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 dimethomorph they are further discussed in the aggregate risk Unit E.

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).

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

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

EPA does not have, at this time, available data to determine whether dimethomorph has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to dimethomorph and any other substances and dimethomorph 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 dimethomorph 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 policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

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

2. Prenatal and postnatal sensitivity . The developmental and reproductive toxicity data did not indicate increased susceptibility of rats or rabbits to in utero and/or postnatal exposure.

3. Conclusion . There is a complete toxicity data base for dimethomorph and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X SF to protect infants and children should be reduced to 1X. The FQPA SF is removed because: Acceptable developmental toxicity studies in the rat and the rabbit are available, as is an acceptable 2-generation reproduction study in the rat and there is no indication of qualitative or quantitative increased susceptibility of rats and rabbits to in utero or postnatal exposure. A developmental neurotoxicity study is not required for dimethomorph. The dietary (food and water) exposure assessments are not expected to underestimate the potential exposures for infants and children from the use of dimethomorph. Residential exposure to dimethomorph is not expected since there are no registered residential uses for the pesticide.

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

When EECs for surface water and groundwater are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water (when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP 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, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process.

1. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to dimethomorph from food will utilize 7% of the cPAD for the U.S. population, 0.8% of the cPAD for all infants < 1 year old, 16% of the cPAD for children 1-2 years old (the most highly exposed population subgroup), and 6% of the cPAD for females 13-49 years old. Based on the lack of residential uses, chronic residential exposure to residues of dimethomorph is not expected. In addition, there is potential for chronic dietary exposure to dimethomorph in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 2 of this unit:

2. Short- and intermediate-term risk . Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Dimethomorph is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern.

3. Aggregate cancer risk for U.S. population . Dimethomorph is no carcinogenic. This classification was based upon lack of evidence of carcinogenicity in rats and mice. The Agency concludes that the pesticidal uses of dimethomorph are not likely to pose a cancer risk to humans.

4. 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 dimethomorph residues.

A reliable method for the determination of dimethomorph residues in fruiting vegetables crop group 8, leafy brassica greens subgroup 5B, taro leaves and roots exists; this method is the FDA Multi-Residue Method, Protocol D, as published in the Pesticide Analytical Manual I.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no established or proposed Codex, Canadian or Mexican maximum residue limits or tolerances for dimethomorph in or on taro, corm; taro, leaves; brassica, leafy greens, subgroup 5B; or vegetable, fruiting, group 8.

Therefore, the tolerances are established for residues of dimethomorph, in or on brassica, leafy greens, subgroup 5B; taro, corm; taro, leaves; and vegetable, fruiting, group 8.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0303 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 28, 2003.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0303, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in 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. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0058. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

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

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

In the Federal Register of May 19, 2000 (65 FR 31904) (FRL-6558-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 0F6140) by Aventis CropScience USA, now Bayer CropScience, PO Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. There were no comments received in response to the notice of filing.

In the Federal Register of July 24, 2002 (67 FR 48465) (FRL-7184-6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP OF6210) by Aventis CropScience USA, now Bayer CropScience, PO Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by Bayer CropScience, the registrant. Comments on the petition were filed by Neil J. Carman, Ph.D. of the Sierra Club Genetic Engineering Committee. A response to these comments is provided in Unit VI.

In the Federal Register of August 21, 2002 (67 FR 54196) (FRL-7190-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide petition (PP 2E6404) by Interregional Research Project Number 4 (IR-4), 681 US Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petition prepared by IR-4, the petitioner. There were no comments received in response to the notice of filing.

In the Federal Register of August 15, 2003 (68 FR 48908) (FRL-7322-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of amended pesticide petitions (PP 0F6140 and PP OF6210) by Bayer CropScience, PO Box 12014, 2 T. W. Alexander Drive, Research Triangle Park, NC 27709. That notice included a summary of the petition prepared by Bayer CropScience. Two hundred and sixty five comments were filed. A response to these comments is provided in Unit VI.

The petitions requested that 40 CFR 180.473(a)(1) be amended by establishing tolerances for residues of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolite, 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or on the raw agricultural commodities derived from cotton, undelinted seed at 3.5 parts per million (ppm) and gin byproducts at 12.0 ppm; and blueberry, lingonberry, juneberry and salal at 0.10 ppm and that 40 CFR 180.473(a)(2) be amended by establishing tolerances for residues of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites, 3-methylphosphinico-propionic acid, and 2-acetamido-4-methylphosphinico-butanoic acid expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents in or on the raw agricultural commodities derived from transgenic cotton tolerant to glufosinate ammonium: undelinted seed at 3.5 ppm and gin byproducts at 12.0 ppm and transgenic rice tolerant to glufosinate ammonium: grain at 1.0 ppm, straw at 1.6 ppm.

IR-4 and Bayer CropScience subsequently amended the petitions to request that 40 CFR 180.473(a)(1) be amended by establishing tolerances for residues of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on the following food commodities: Bushberry subgroup, lingonberry, juneberry and salal at 0.15 ppm, cattle, fat at 0.40 ppm, cattle, meat at 0.15 ppm, cattle, meat byproducts at 6.0 ppm, cotton, gin byproducts at 15 ppm, cotton, undelinted seed at 4.0 ppm, egg at 0.15 ppm, goat, fat at 0.40 ppm, goat, meat at 0.15 ppm, goat, meat byproducts at 6.0 ppm, hog, fat at 0.40 ppm, hog, meat at 0.15 ppm, hog, meat byproducts at 6.0 ppm, horse, fat at 0.40 ppm, horse, meat at 0.15 ppm, horse, meat byproducts at 6.0 ppm, Milk at 0.15 ppm, poultry, fat at 0.15 ppm, poultry, meat at 0.15 ppm, poultry, meat byproducts 0.6 ppm, sheep, fat at 0.40 ppm, sheep, meat at 0.15 ppm, and sheep, meat byproducts at 6.0 ppm.

Bayer CropScience subsequently amended the petitions to request that 40 CFR 180.473(a)(2) be amended by establishing tolerances for residues of the herbicide glufosinate ammonium (butanoic acid, 2-amino-4-(hydroxymethylphosphinyl)-, monoammonium salt) and its metabolites, 2-acetamido-4-methylphosphinico-butanoic acid and 3-methylphosphinico-propionic acid, expressed as 2-amino-4-(hydroxymethylphosphinyl)butanoic acid equivalents, in or on the following raw agricultural and processed commodities derived from transgenic cotton and rice that are tolerant to glufosinate ammonium: Cotton, gin byproducts at 15 ppm, cotton, undelinted seed at 4.0 ppm, rice, grain at 1.0 ppm, rice, straw at 2.0 ppm, and rice, hull at 2.0 ppm. These amendments were included in the August 15, 2003 notice of filing.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of glufosinate ammonium and its metabolites on bushberry subgroup, lingonberry, juneberry and salal at 0.15 ppm, cattle, fat at 0.40 ppm, cattle, meat at 0.15 ppm, cattle, meat byproducts at 6.0 ppm, cotton, gin byproducts at 15 ppm, cotton, undelinted seed at 4.0 ppm, egg at 0.15 ppm, goat, fat at 0.40 ppm, goat, meat at 0.15 ppm, goat, meat byproducts at 6.0 ppm, hog, fat at 0.40 ppm, hog, meat at 0.15 ppm, hog, meat byproducts at 6.0 ppm, horse, fat at 0.40 ppm, horse, meat at 0.15 ppm, horse, meat byproducts at 6.0 ppm, milk at 0.15 ppm, poultry, fat at 0.15 ppm, poultry, meat at 0.15 ppm, poultry, meat byproducts at 0.60 ppm, sheep, fat at 0.40 ppm, sheep, meat at 0.15 ppm, and sheep, meat byproducts at 6.0 ppm, cotton, gin byproducts at 15 ppm, rice, grain at 1.0 ppm, rice, straw at 2.0 ppm, and rice, hull at 2.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by glufosinate ammonium and its metabolites are discussed in Tables 1, 2 and 3 of this unit as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. A 10x data base uncertainty factor, due to the lack of a developmental neurotoxicity study, was applied to all dietary and residential dermal, inhalation, and incidental oral exposure assessments. For residential inhalation exposure assessments an additional 10x data base uncertainty factor was applied due to the lack of an adequate inhalation study and high concern for exposure via the inhalation route (10,000). Agency policy limits the total uncertainty factor applied for any particular chemical to no more than 3,000 (see EPA report “A Review of the Reference Dose and Reference Concentration Processes:” EPA/630/P-02/022F, December 2002; a Notice of Availability of the Final Report was published in the Federal Register of May 21, 2003 (68 FR 27805) (FRL-7501-8).

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 factors (SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose (aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF.

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for glufosinate ammonium and its metabolite used for human risk assessment is shown in Table 4 of this unit:

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.473) for the combined residues of glufosinate ammonium and its metabolites, in or on almond hulls, apples, bananas, meat, milk, fat, meat byproducts, eggs, grapes, potatoes, tree nuts and food commodities derived from transgenic canola, transgenic field corn, transgenic soybean and transgenic sugar beets. Risk assessments were conducted by EPA to assess dietary exposures from combined residues of glufosinate ammonium and its metabolites as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model-Food Consumption Intake Database (DEEM-FCID ® ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% crop treated for all registered and proposed commodities (Tier 1 analysis) and, depending on the level of blending of a commodity, tolerance level residues, highest field trial, or average field trial.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the DEEM-FCID ® analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: 100% crop treated for all registered and proposed commodities (Tier 1 analysis) excluding apple, canola, corn and grape, where 3 year weighted average percent crop treated was used, and, depending on the level of blending of a commodity, tolerance level residues or average field trial.

iii. Cancer . No evidence of carcinogenicity at doses tested were observed in the mouse and rat carcinogenicity studies. A quantitative cancer risk assessment was not performed for glufosinate ammonium.

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(F) of the FFDCA 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 PCT as required by section 408(b)(2)(F) of the FFDCA, EPA may require registrants to submit data on PCT.

The Agency believes that the three conditions listed in Unit IV. 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 3 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. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. 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 glufosinate ammonium 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 glufosinate ammonium 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 glufosinate ammonium. Based on environmental fate data the residues of concern in drinking water are glufosinate ammonium, 3-methylphosphinico-propionic acid, 2-methylphosphinico-acetic acid and N -acetyl-glufosinate.

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 groundwater. For a screening-level assessment for surface water EPA will use FIRST (a tier 1 model) before using PRZM/EXAMS (a tier 2 model). The FIRST model is a subset of the PRZM/EXAMS model that uses a specific high-end runoff scenario for pesticides. While both FIRST and PRZM/EXAMS incorporate an index reservoir environment, the PRZM/EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin.

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

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

Based on the PRZM-EXAMS and SCI-GROW models the EECs of glufosinate ammonium and its degradates for acute exposures are estimated to be 94 μg/liter for surface water and 9 μg/liter for ground water. The EECs for chronic exposures are estimated to be 43 μg/liter for surface water and 9 μg/liter for ground water.

3. 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).

Glufosinate ammonium is currently registered for use on the following residential non-dietary sites: Home use for spot treatment of weeds, grass, bushes and vines. The risk assessment was conducted using the following residential exposure assumptions: Application rate of 0.0312 lb active ingredient (ai) per 1,000 ft 2 , dermal unit exposure of 11 mg/lb and inhalation exposure of 0.016 mg/lb from hose end application and dermal unit exposure of 56 mg/lb and inhalation exposure of 0.0065 mg/lb from low pressure hand wand application.

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

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

• Crop production (NAICS 111)

• Animal production (NAICS 112)

• Food manufacturing (NAICS 311)

• Pesticide manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0218. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

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

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

In the Federal Register of May 30, 2003 (68 FR 32497) (FRL-7295-7), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (PP 1E6302 and 2E6474) by the Interregional Research Project Number (IR-4), 681 U.S. Highway #1 South, North Brunswick, NJ 08902. That notice included a summary of the petitions prepared by Dow AgroSciences LCC, the registrant. The comment period ended June 30, 2003.

The petitions requested that 40 CFR 180 be amended by establishing tolerances for residues of the fungicide quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline, in or on grape at 0.70 parts per million (ppm) (1E6302); hop, dried cones at 5 ppm (1E6302); and cherry at 0.4 ppm (2E6474).

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for tolerances for residues of quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline in or on cherry, sweet at 0.30 ppm; cherry, tart at 0.30 ppm; grape at 0.60 ppm; and hop, dried cones at 3.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

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

The primary target organs affected by quinoxyfen are the liver and kidney. Liver effects were seen in rat and mouse subchronic and dog chronic studies. Subchronic effects in rats and mice included increased liver weights, hepatocellular hypertrophy and individual cell hepatocellular necrosis. These effects were noted at high doses and not observed in the chronic rat and mouse studies since they were performed at lower doses. Chronic effects in the dog included increased liver weights, increased alkaline phosphatase levels and increased incidences of slight microscopic hepatic lesions (increased bile in canaliculi and increased hepatocyte size). Kidney effects were noted only in the rat combined chronic/carcinogenicity study which resulted in an increased severity of chronic progressive glomerulonephropathy in the males. Rabbits were much more susceptible to the effects of quinoxyfen than any other species. Systemic effects observed in the rabbit developmental study included inanition, loss of body weight, perineal soiling, blood in the cage pan associated with urine, and abortions. Body weight decrements were noted in the rat and/or mouse subchronic, chronic and carcinogenicity studies and the rabbit developmental and rat reproduction studies. No effects were noted via the dermal route. No evidence of neurotoxicity or neuropathology was seen in any of the submitted studies, including the acute and subchronic neurotoxicity studies. There was no evidence of carcinogenic potential in either the rat chronic toxicity/carcinogenicity or mouse carcinogenicity studies and no concern for mutagenicity. There was no evidence of increased susceptibility in the oral rat or rabbit developmental studies. There was an increased quantitative susceptibility of young animals following pre/postnatal exposure to rats in the reproduction study. In this study, no maternal effects were observed up to the highest dose tested (100 milligrams/kilograms/day (mg/kg/day)); however, minimally reduced F 1a pup weights were noted at 100 mg/kg/day.

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

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

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

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

1. Dietary exposure from food and feed uses . Quinoxyfen is a new chemical and therefore, these are the first tolerances to be established for the residues of quinoxyfen. Risk assessments were conducted by EPA to assess dietary exposures from quinoxyfen in food as follows:

i. Acute exposure . Quantitative acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. There were no toxic effects attributable to a single dose. Therefore, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. As a result, no acute risk is expected from exposure to quinoxyfen and hence no quantitative acute dietary risk assessment was performed.

ii. Chronic exposure . In conducting this chronic dietary risk assessment, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID TM ) which incorporates food consumption data as reported by respondents in the USDA 1994-1996 and 1998 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: An unrefined, Tier 1 chronic-dietary exposure assessment using tolerance-level residues and assuming 100% CT for all proposed commodities, and default DEEM Version 7.76 processing factors for all commodities.

iii. Cancer . Quinoxyfen has been classified as not likely to be carcinogenic to humans. Therefore, a quantitative risk assessment was not conducted to assess cancer risk.

2. Dietary exposure from drinking water . The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for quinoxyfen 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 quinoxyfen.

The Agency uses the FQPA Index Reservoir Screening Tool (FIRST) or the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentrations in Ground Water (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. Both FIRST and PRZM/EXAMS incorporate an index reservoir environment, and both models include 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 quinoxyfen, they are further discussed in the aggregate risk sections see Unit E.

Based on the FIRST and SCI-GROW models, the EECs of quinoxyfen for chronic exposures are estimated to be 0.8 parts per billion (ppb) for surface water and 0.006 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). Quinoxyfen is not registered for use on any sites that would result in residential exposure.

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

EPA does not have, at this time, available data to determine whether quinoxyfen has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to quinoxyfen and any other substances and quinoxyfen 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 quinoxyfen 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 policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/ .

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

2. Prenatal and postnatal sensitivity . There is no quantitative or qualitative evidence of increased susceptibility of rat and rabbit fetuses to in utero exposure in developmental studies. There is evidence of increased quantitative susceptibility (minimal decrease in F 1a pup weights) in the rat multi-generation reproduction study, but the concern is low since: (1) The effects in pups are well-characterized with a clear NOAEL; (2) the pup effects are minimal at the LOAEL and only noted in the first-generation offspring; and (3) the doses and endpoints selected for regulatory purposes would address the concerns of the pup effects noted in the rat reproduction study. Therefore, there are no residual uncertainties for prenatal/postnatal toxicity in this study.

3. Conclusion . There is a complete toxicity data base for quinoxyfen and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. There are no residual uncertainties for prenatal/postnatal toxicity. No additional safety factor is needed for data base uncertainties. No clinical sign of neurotoxicity or neuropathology was seen in the data base. A developmental neurotoxicity study is not required. Therefore, EPA determined that the 10X SF to protect infants and children should be reduced to 1X.

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: 2 liter (L)/70 kg (adult male), 2L/60 kg (adult female and youth), 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 . An endpoint of concern was not identified to quantitate acute-dietary risk to the general population or to the subpopulation females 13-50 years old. As a result, no acute risk is expected from exposure to quinoxyfen.

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to quinoxyfen from food will utilize less than 1% of the cPAD for the U.S. population, 1% of the cPAD for all infants ( < 1 year old) and 1% of the cPAD for children (1-2 years old), the children subpopulation at greatest exposure. There are no residential uses for quinoxyfen that result in chronic residential exposure to quinoxyfen. In addition, there is potential for chronic dietary exposure to quinoxyfen in drinking water. After calculating DWLOCs and comparing them to the EECs for surface water and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 3 of this unit:

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

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

5. Aggregate cancer risk for U.S. population . Quinoxyfen has been classified as not likely to be carcinogenic to humans. Therefore, quinoxyfen is not expected to pose a cancer risk.

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 quinoxyfen residues.

IR-4 has proposed a gas chromatography (GC) method with mass-selective detection (MSD) entitled Determination of DE-795 Residues in Grape Wine, Must, and Pomace ERC95.26 (and its supplement S1) for the enforcement of proposed tolerances for residues of quinoxyfen in/on grapes, cherries, and hops. Method ERC 95.26 is classified as acceptable and conforms with the criteria of OPPTS Harmonized Guideline 860.1340. The petitioner has submitted a study which investigated the behavior of quinoxyfen through MRMs outlined in FDA's Pesticide Analytical Manual (PAM), Volume I, Appendix II. The study summary reported that depending on spike levels, certain MRM Protocols (D, E, and F) yielded partial (incomplete) to complete recoveries of quinoxyfen in grapes (non-fatty matrix) and ground beef (fatty matrix).

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address: residuemethods@epa.gov .

There are no Mexican, Canadian or Codex maximum residue limits established for quinoxyfen on sweet and tart cherries, grapes, or hops. Therefore, no compatibility problems exist for these tolerances.

Therefore, tolerances are established for quinoxyfen, 5,7-dichloro-4-(4-fluorophenoxy)quinoline in or on cherry, sweet at 0.30 ppm; cherry, tart at 0.30 ppm; grape at 0.60 ppm; and hop, dried cone at 3.0 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0218 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 28, 2003.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0218, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

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

• Crop Production (NAICS 111)

• Animal Production (NAICS 112)

• Food Manufacturing (NAICS 311)

• Pesticide Manufacturing (NAICS 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0315. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

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

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

In the Federal Register of January 18, 2000 (65 FR 2612) (FRL-6486-4), August 7, 2002 (67 FR 51267) (FRL-7191-3), and September 11, 2002 (67 FR 57593) (FRL-7198-11), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of pesticide petitions (9E6012, 9E6021, and 0E6150) by the Interregional Research Project Number 4, Technology Centre and Rutgers State University of New Jersey, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390 and pesticide petition (2F4075) by BASF Corporation, P.O. Box 13528, Research Triangle Park, NC 27709-3528. These notices included summaries of the petitions prepared by BASF Corporation, the registrant. There were no comments received in response to these notices of filing.

These petitions requested that 40 CFR part 180 be amended to establish tolerances for cyclohexen-1-one moiety (calculated as the herbicide), in or on corn, sweet, forage at 3.0 parts per million (ppm); corn, sweet, stover at 3.5 ppm; lingonberry at 5.0 ppm; juneberry at 5.0 ppm; pistachios at 0.2 ppm; safflower at 15.0 ppm and salal at 5.0 ppm, and increase the tolerance in cattle, meat byproducts from 0.2 ppm to 1.0 ppm; corn, sweet, kernels plus cob with husk removed from 0.2 ppm to 0.4 ppm; goat, meat byproducts from 0.2 ppm to 1.0 ppm; horse, meat byproducts from 0.2 ppm to 1.0 ppm; milk from 0.05 ppm to 0.5 ppm, and sheep, meat byproducts from 0.2 ppm to 1.0 ppm. The tolerance increases were a result of a 15-day reduction in the pre-harvest interval for sweet corn requested by the registrant.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for combined residues of the herbicide sethoxydim, (2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one) and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as the herbicide), in or on corn, sweet, kernels plus cob with husk removed at 0.4 ppm; corn, sweet, forage at 3.0 ppm; corn, sweet, stover at 3.5 ppm; lingonberry at 5.0 ppm; juneberry at 5.0 ppm; milk at 0.5 ppm; cattle, meat byproducts at 1.0 ppm; goat, meat byproducts at 1.0 ppm; hog, meat byproducts at 1.0 ppm; horse, meat byproducts at 1.0 ppm and sheep meat byproducts at 1.0 ppm; pistachio at 0.2 ppm; safflower at 15.0 ppm and salal at 5.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The natures of the toxic effects caused by sethoxydim are discussed in Table 1 of this unit 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 potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

1. Docket . EPA has established an official public docket for this action under docket identification (ID) number OPP-2003-0256. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The docket telephone number is (703) 305-5805.

2. Electronic access . You may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml _00/Title _40/40cfr180 _00.html , a beta site currently under development.

An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the appropriate docket ID number.

In the Federal Register of July 30, 2003 (68 FR 447804) (FRL-7319-7), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a(e), as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 3F6736) by AgriVir, LLC, 1901 L Street, NW., Suite 250, Washington, DC 20036. This notice included a summary of the petition prepared by the petitioner AgriVir, LLC. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1218 be amended by establishing an exemption from the requirement of a tolerance for residues of IMMGV.

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

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

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

Based on the toxicology data cited and the limited exposure to humans and domestic animals, there is a reasonable certainty that no harm will result from aggregate exposure to IMMGV to the U.S. population including infants and children to residues of IMMGV when used as viral pest control agent to control the Indian Meal Moth on all food commodities. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the long history of research, use and safety of testing baculoviruses which is documented in the public scientific literature (Refs. 1-5). IMMGV is a naturally occurring organism to which some environmental and dietary exposure is likely to be common for most individuals. The conclusion of safety is further supported by the lack of toxic or pathogenic effects on test animals at high doses (data submitted by the registrant, MRID numbers 453070-01, 450662-07, and 450662-08). Baculoviruses have been described in the scientific literature for approximately 40 years. In addition to their natural occurrence, these viruses have a long history of safe use as bioinsecticides. Baculoviruses have been studied extensively in both laboratory and field experiments, which have shown that the virus host range is limited to arthropods. IMMGV has been shown to be very restricted in its insect host range. No toxicological or pathogenic effects produced by the baculovirus itself, have been observed in mammals, birds, fish or plants. The lack of mammalian toxicity at high levels of exposure to IMMGV demonstrates the safety of the product at levels well above maximum possible exposure levels anticipated in the crops. There has been a significant amount of research performed on baculoviruses and numerous scientific references are available which describe the biology of these viruses, their host range, and their mode of action. Toxicity studies submitted in support of this tolerance exemption include the following:

1. Acute oral toxicity/pathogenicity (453070-01) . Thirteen male (254-321 grams (g)) and 13 female (160-208g) albino rats were divided into three groups and treated with 0.1 milliliter (mL) of the test substance. Treatment was administered by oral gavage with at least 1 x 10 8 viral particles per animal. No deaths occurred in any of the test animals. Other than diarrhea during the first few hours following dosing, there were no other apparent clinical symptoms. Based upon the data there were no significant adverse effects reported upon doses of at least 1 x 10 8 viral capsules. The toxicity category was deemed Toxicity Category IV.

2. In vitro mammalian cell viral infectivity in mammalian cells (450662-08) . Human WI-38 and WS1 cell cultures and African green monkey CV-1 cell cultures were exposed to 1 x 10 6 units of the test substance. The cell cultures were observed daily for 21 days following inoculation for virus induced cytopathic effects. The test preparation was shown to be highly infectious and cytopathic to the target Plodia interpunctella larva. No differences were seen between the virus treated nor the solvent treated control cell cultures with respect to any cytopathic endpoint at any time post-inoculation. Based on the data, there was no evidence that the virus could infect any of the three mammalian cell lines.

3. In vitro mammalian cell viral induced cytotoxicity (450662-07) . Human WI-38 and WS1 cell cultures and African green monkey CV-1 cell cultures were exposed to 1 x 10 6 units of IMMGV technical (IMMGV) for 1 hour. The cell cultures were then washed, refed with virus-free medium, incubated for 8 days, fixed, stained and the number of colonies counted. The test preparation was shown to be highly infectious and cytopathic to the target Plodia interpunctella larva although analysis determined that the actual number of viral capsules used was only 42% of the target value. No differences were seen between the virus treated and the solvent treated control cell cultures with respect to cloning efficiency in any of the three cell lines. Based on the data, there was no evidence that the test substance was cytotoxic to any of the three mammalian cell lines.

4. Acute eye irritation (450662-09) . The test substance was instilled in the eyes of four males and two female adult New Zealand albino rabbits at approximately 0.04 g/eye (~7.14 x 10 9 viral capsules). Animals were acclimated for 11 days and before treatment their eyes were checked for normalcy using ophthalmic fluorescein and an ultraviolet (UV) lamp. The right eye of each animal was treated and the other eye served as a control. No deaths occurred. Clinical signs noted included conjunctivitis, corneal opacity and iritis, all of which cleared within 4 days of treatment. The toxicity from this study was deemed Toxicity Category IV.

5. Data waivers . Data waivers were requested for the following studies:

i. Acute dermal toxicity . This study was waived based upon the lack of toxicity in animals dosed orally (453070-01) and more importantly cells inoculated with viral pest control agent (450662-07 and 450662-08). Cell culture infectivity and cytoxicity assays demonstrated that there were no toxic effects to mammalian cell lines (human lung, human endothelial and primate renal cell lines) when innoculated with doses of IMMGV. Cell culture assays provide valuable information on the ability of the viral pest control agent to infect, replicate in, transform or cause toxicity in mammalian cell lines. Thus, this assay is the most likely indicator of evaluating the toxicity of a viral pest control agent. Unlike the oral, dermal and inhalation routes of exposure, these barriers (exposure conditions) do not exist in cell culture assays as the host cell is completely exposed, thus, providing a higher exposure scenario (for exposure of body tissues, organs and systems). Cell culture studies which demonstrate no toxicity to mammalian cell lines upon inoculation with the viral pest control agent can therefore be used as an indicator in determining the probability of toxicity to the viral pest control agent via other routes of exposure (oral, dermal, inhalation). Therefore, this evaluation criteria along with the data submitted (referenced above) and the long history of safe use of baculoviruses provided the Agency with a scientific rationale to waive the requirement for an acute dermal toxicity study. In addition, the IMMGV is a characteristically large molecular entity and is therefore unable to penetrate intact skin. However, in the unlikely event that viral penetration does occur through contact with broken skin, the studies submitted by the registrant have demonstrated a lack of toxicity/pathogenicity and infectivity associated with IMMGV.

ii. Acute inhalation toxicity . This study was waived based upon the lack of toxicity in animals dosed orally (453070-01) and, more importantly cells inoculated with the viral pest control agent (450662-07 and 450662-08). Cell culture infectivity and cytoxicity assays demonstrated that there were no toxic effects to mammalian cell lines (human lung, human endothelial and primate renal cell lines) when infected with doses of IMMGV. Cell culture assays provide valuable information on the ability of the viral pest control agent to infect, replicate in, transform or cause toxicity in mammalian cell lines. Thus, this assay is the most likely indicator of evaluating the toxicity of a viral pest control agent. Unlike the oral, dermal and inhalation routes of exposure, these barriers (exposure conditions) do not exist in cell culture assays as the host cell is completely exposed thus providing a higher exposure scenario (for exposure of body tissues, organs and systems). Cell culture studies which demonstrate no toxicity to mammalian cell lines upon infection with the viral pest control agent can therefore be used as an indicator in determining the probability of toxicity to the viral pest control agent via other routes of exposure (oral, dermal and inhalation). Therefore, this evaluation criteria along with the data submitted (referenced above) and the long history of safe use of baculoviruses provided the Agency with a scientific rationale to waive the requirement for an acute inhalation toxicity study. In addition, the product labeling includes precautionary language for the pesticide handler to use a dust mask as a further measure of safety.

iii. Primary dermal irritation . This study was waived based upon the lack of toxicity in animals dosed orally (453070-01) and, more importantly cells inoculated with viral pest control agent (450662-07 and 450662-08). Cell culture infectivity and cytoxicity assays demonstrated that there were no toxic effects to mammalian cell lines (human lung, human endothelial and primate renal cell lines) when infected with doses of IMMGV. Cell culture assays provide valuable information on the ability of the viral pest control agent to infect, replicate in, transform or cause toxicity in mammalian cell lines. Thus, this assay is the most likely indicator of evaluating the toxicity of a viral pest control agent. Unlike the oral, dermal and inhalation routes of exposure, these barriers (exposure conditions) do not exist in cell culture assays as the host cell is completely exposed thus providing a higher exposure potential (for exposure of body tissues, organs and systems). Cell culture studies which demonstrate no toxicity to mammalian cell lines upon infection with the viral pest control agent can therefore be used as an indicator in determining the probability of toxicity to the viral pest control agent via other routes of exposure (oral, dermal and inhalation). Therefore, this evaluation criteria along with the data submitted (referenced above) and the long history of safe use of baculoviruses provided the Agency with a scientific rationale to waive the requirement for an acute dermal toxicity study. In addition, the product labeling includes precautionary language for the pesticide handler to wear gloves as a further measure of safety.

iv. Literature citations (450662-06) . Information from the open scientific literature has been cited in support of the relative safety and lack of mammalian toxicity associated with baculoviruses, including the IMMGV. The IMMGV is very host-specific, it does not infect any host other than the Indian meal moth larvae and does not cross-infect any Lepidopteran or other insect. The range for the insect host is worldwide. Studies listed in the literature review provide information on the life cycle and mode of action of IMMGV such that it acts by pathogenicity, not a toxic mechanism. It presents no hazard potential to mammals and non-target species.

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

1. Food . Because baculoviruses are naturally occurring organisms, there is a great likelihood for previous exposure for most, if not all individuals. To date, there have been no reports of any hypersensitivity incidents or reports of any known adverse reactions resulting from exposure to IMMGV. The amount of product used will result in a negligible increase, if any, of virus exposure. In addition, even if there is a significant increase in exposure to the virus, the toxicity studies submitted by the registrant along with the extensive reports in the scientific literature indicating the safety of the viruses, suggest that there should not be any additional risk of adverse effects due to exposure to IMMGV.

2. Drinking water exposure . Because of the use site and amount of product that will be applied, potential non-occupational exposures in drinking water is negligible. Currently, there are no reports which show that IMMGV has been found in any drinking water. Baculoviruses occur naturally in soil and there is a low likelihood that they would survive passage through the soil to reach underground water (Ref. 1, MRID 450662-06). Even if the virus is able to reach ground water, it is highly unlikely that the viruses would survive municipal water treatment due to its inability to survive outside its host. Therefore, it is not likely there will be an increase of IMMGV in drinking water. In addition, because the virus host range is limited to the Indian meal moth, the results of the acute oral toxicity studies using a high dose of the virus, suggest that there will not be any adverse effects upon human consumption in the unlikely event any virus found its way into drinking water, therefore; the Agency has no drinking water exposure concerns.

Baculoviruses are naturally occurring viruses that have been described in the scientific literature for approximately 40 years. In addition to scientific research, there has been a long history of safe use of baculoviruses to control arthropods. Because the amount of virus which will be applied is small, it is not likely that there will be a significant increase in potential exposure. Any increase in virus titer is likely to be negligible at most. Baculoviruses have been shown to have a host range limited to arthropods and the host range of this virus is even more restrictive than most baculoviruses (Ref. 1, MRID 450662-06). Therefore, even if there was an increase in exposure, there should not be any increase in potential human health effects.

The Agency has considered available information on the cumulative effects of such residues and other substances that have a common mechanism of toxicity. These considerations included the cumulative effects on infants and children of such residues and other substances with a common mechanism of toxicity. Because there is no indication of mammalian toxicity to this or other baculovirus-containing products, the Agency is confident that there will not be cumulative effects from the registration of this product.

1. U.S. population . There is a reasonable certainty that no harm will result from aggregate exposure to the U.S. population from exposure to residues of IMMGV. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion based on the long history of safe use of baculoviruses as bioinsecticides, the lack of mammalian toxicity associated with IMMGV, the limited host range of the virus and the inability of IMMGV to infect mammalian cell lines.

2. Infants and children . FFDCA section 408 provides that EPA shall apply an additional tenfold margin of exposure (MOE) (safety) for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different MOE will be safe for infants and children. MOEs are often referred to as uncertainty (safety) factors. In this instance, based on all the available information, the Agency concludes that IMMGV is practically non-toxic to mammals, including infants and children and that they will consume only minimal, if any, residues of the microbial pesticide. Thus, there are no threshold effects of concern and, as a result, the provision requiring an additional margin of safety does not apply. Further, the provisions of consumption patterns, special susceptibility, and cumulative effects do not apply.

As a result, EPA has not used a MOE approach to assess the safety of the IMMGV.

There are no reports or indications in the available scientific literature that suggests that Indian meal moth granulosis virus has caused or has the potential to cause adverse effects on the endocrine and/or immune systems of humans or animals. The virus host range is limited to the Indian meal moth, where it would be expected to affect the defense systems of the target insect pest. The target insect's response is not different from any animal's response to a disease agent. These suppositions are confirmed by the results of the mammailian toxicity tests cited above.

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purposes for the IMMGV.

There are no Codex Maximum Residue Levels established for residues of the IMMGV.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0256 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 28, 2003.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0256, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.1. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov . Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

1. Consigili, R.A., D.L., Russell and M.E. Wilson. 1986. The biochemistry and molecular biology of the granulosis virus that infects plodia interpunctella. Current Topics in Microbiology and Immunology 131:69-101.

2. Doller, G. 1985. The safety of insect virus as biological control agents. In “Viral Insecticides for Biolocial Control” (Eds. Maramorosch, K. and Sherman, H.G.), Academic Press, New York: 399.

3. Groner, A. 1986. Specificity and safety of baculoviruses. In “The Biology of Baculoviruses Vol. I: Biological Properties and Molecular Biology” (Eds. Granados, R.D. and Federici, B.A.), CRC Press, Boca Raton, Florida: 177-202).

4. Heimpel, A.M. 1971. Safety of insect pathogens for man and vertebrates. In “Microbial Control of Insects and Mites” (Eds. Burges, H.D. and Hussey, N.W.), Academic Press, New York: 469-489.

5. Hunter, D.K. 1970. Pathogenicity of a granulosis virus of the Indian meal moth. J. Invertebr. Pathol. 16:339-341.

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

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

In FR Doc. 03-19677 of August 4, 2003 (68 FR 46036), there were a number of technical errors that are identified and corrected in the “Correction of Errors” section below. The provisions in this correction document are effective as if they had been included in the document published August 4, 2003. Accordingly, the corrections are effective October 1, 2003.

In previous years, we have issued correction notices with respect to payment rates under the prospective payment system (PPS) for skilled nursing facilities (SNFs), reflecting minor adjustments to the hospital wage index relating to specific Metropolitan Statistical Areas (MSAs). For example, for fiscal year (FY) 2003, we issued a correction notice (December 27, 2002, 67 FR 79123) to update two MSA wage indexes. We did not recalculate the SNF budget neutrality factor as a result of these minor revisions.

However, it was recently determined that computational errors in the hospital wage index calculation process for FY 2004 were of sufficient magnitude to affect all of the published PPS payment rates for inpatient hospital services. A description of those computational errors will be included in a notice specific to the hospital inpatient PPS. As we explained in the August 4, 2003 final rule, the SNF wage index values reflect the wage data used in the FY 2004 inpatient hospital PPS rates, and therefore, we believe it would be appropriate to incorporate corrections to the inpatient hospital wage index. The scope of the resulting corrections to the hospital wage index will, in turn, necessitate revising the budget neutrality factor for the SNF PPS for FY 2004 as well. We note that correcting these computational errors is a purely administrative function that does not result in any change of policy or payment methodology.

Accordingly, in this correction document, we are republishing the SNF PPS payment rate tables (that is, Tables 1 through 9, inclusive) that appeared in the August 4, 2003 final rule, in order to show the corrected rates. (We note that we are not republishing Table 10 (FY 2004 Labor-Related Share (68 FR 46057)), as this table solely involves the relative importance of the various components of the labor-related share, and those figures have not changed from those that appeared in the final rule.) Further, we are republishing Table 11, which displays the projected impact of the FY 2004 SNF PPS payment update, including the variation in impact by region and by certain other facility characteristics. We note that the effect of the corrections being made in this notice is solely distributional in nature and, accordingly, that there is no change in the estimated aggregate expenditures for FY 2004 as set forth in the August 4, 2003 final rule. A further discussion of the projected impact of the FY 2004 SNF PPS payment update can be found in the August 4, 2003 final rule (68 FR 46067). In addition, the FY 2004 budget neutrality factor of 1.005 that appeared in the final rule (68 FR 46047) is hereby revised to 1.0016.

Finally, in the August 4, 2003 final rule (68 FR 46060), we added two radiopharmaceuticals, Zevalin and Bexxar, to the list of chemotherapy drugs that are excluded from consolidated billing (and, thus, are separately billable to Part B when furnished to a SNF resident during a covered Part A stay). We note that Healthcare Common Procedure Coding System (HCPCS) coding for Bexxar is currently in the process of being developed. Further, while the final rule identified HCPCS codes A9522 and A9523 for Zevalin, we note that the outpatient hospital PPS currently uses HCPCS codes G0273 and G0274 for Zevalin instead, and that further revision of these particular codes is possible in the near future. As we stated in the final rule, the consolidated billing exclusions will appear in a Consolidated Billing Annual Update Program Memorandum that we will issue at the end of CY 2003, and will be effective as of January 1, 2004 (68 FR 46059). Accordingly, we are clarifying as an interpretive matter that the HCPCS codes to be utilized in connection with Bexxar and Zevalin include any successor codes that may replace the codes currently listed in the regulation. Such successor codes would be disseminated through program instructions. Once HCPCS coding has been developed for Bexxar (and has been definitively established for Zevalin), we will make revisions, as appropriate, to the particular codes that appear in the regulations text at § 411.15(p)(2)(xii) and § 489.20(s)(12).

In FR Doc. 03-19677 of August 4, 2003 (68 FR 46036), make the following corrections:

1. On page 46040, Tables 1 and 2 are revised to read as follows:

2. On pages 46042 through 46043, Table 3 is revised to read as follows:

3. On Pages 46044 through 46045, Table 4 is revised to read as follows:

4. On page 46047, in the third column; in the first paragraph, the budget neutrality factor of “1.005” that appears in the penultimate sentence is revised to read “1.0016”.

5. On page 46048, Table 5 is revised to read as follows:

6. On page 46049, Table 6 is revised to read as follows: