The FAA has determined that notice and opportunity for public comment in accordance with 14 CFR 11.38 are unnecessary, because the FAA has provided previous opportunities to comment on substantially identical special conditions and has fully considered and addressed all the substantive comments received. Based on a review of the comment history and the comment resolution, the FAA is satisfied that new comments are unlikely. The FAA, therefore, finds that good cause exists for making these special conditions effective upon issuance.

However, the FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.

We will file in the docket all comments we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning these special conditions. The docket is available for public inspection before and after the comment closing date. If you wish to review the docket in person, go to the address in the ADDRESSES section of this preamble between 7:30 a.m. and 4 p.m., Monday through Friday, except Federal holidays.

We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.

If you want the FAA to acknowledge receipt of your comments on these special conditions, include with your comments a pre-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it back to you.

On May 1, 2002, J.R.G Design submitted an application to the New York Aircraft Certification Office for a Supplemental Type Certificate (STC). The Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes are being modified for use by a head of state; they are non N-registered airplanes operating under part 91. This project involves replacing round dial displays in the cockpit with four EFIS displays. The EFIS upgrade is for multiple airplane installations. These systems may be vulnerable to HIRF external to the airplane.

Under the provisions of 14 CFR 21.17, J.R.G Design, Inc. must show that Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes meet the applicable provisions in effect on the date of application for the supplemental type certificate or applicable provisions of 14 CFR part 25, as amended by Amendments 21-1 through 25-106, for areas affected by the change to the greatest extent feasible. If the Administrator finds that the applicable airworthiness regulations ( i.e., part 25 as amended) do not contain adequate or appropriate safety standards for Boeing Model 747SP series; 747-100 series; and 747-200 series airplanes because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

In addition to the applicable airworthiness regulations and special conditions, Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36, and the FAA must issue a finding of regulatory adequacy pursuant to § 611 of Public Law 92-574, the “Noise Control Act of 1972.”

Special conditions, as defined in 14 CFR 11.19, are issued in accordance with § 11.38 and become part of the type certification basis in accordance with § 21.101(a)(2).

Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, these special conditions would also apply to the other model under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

As noted earlier, Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes will incorporate four EFIS displays (two for each pilot) that will perform critical functions. These systems may be vulnerable to HIRF external to the airplane. The current airworthiness standards of part 25 do not contain adequate or appropriate safety standards for the protection of this equipment from the adverse effects of HIRF. Accordingly, these systems are considered to be novel or unusual designs.

There is no specific regulation that addresses protection requirements for electrical and electronic systems from HIRF. Increased power levels from ground-based radio transmitters and the growing use of sensitive avionics/electronics and electrical systems to command and control airplanes have made it necessary to provide adequate protection.

To ensure that a level of safety is achieved equivalent to that intended by the regulations incorporated by reference, special conditions are needed for Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes. These special conditions require that avionic/electronic and electrical systems that perform critical functions be designed and installed to preclude component damage and interruption of function due to both the direct and indirect effects of HIRF.

With the trend toward increased power levels from ground-based transmitters and the advent of space and satellite communications, coupled with electronic command and control of the airplane, the immunity of critical avionic/electronic and electrical systems to HIRF must be established.

It is not possible to precisely define the HIRF to which the airplane will be exposed in service. There is also uncertainty concerning the effectiveness of airframe shielding for HIRF. Furthermore, coupling of electromagnetic energy to cockpit-installed equipment through the cockpit window apertures is undefined. Based on surveys and analysis of existing HIRF emitters, an adequate level of protection exists when compliance with the HIRF protection special condition is shown with either paragraph 1 or 2 below:

1. A minimum threat of 100 volts rms (root-mean-square) per meter electric field strength from 10 KHz to 18 GHz.

a. The threat must be applied to the system elements and their associated wiring harnesses without the benefit of airframe shielding.

b. Demonstration of this level of protection is established through system tests and analysis.

2. A threat external to the airframe of the field strengths identified in the table below for the frequency ranges indicated. Both peak and average field strength components from the table are to be demonstrated.

The threat levels identified above are the result of an FAA review of existing studies on the subject of HIRF, in light of the ongoing work of the Electromagnetic Effects Harmonization Working Group of the Aviation Rulemaking Advisory Committee.

As discussed above, these special conditions are applicable to Boeing Model 747SP series; 747-110 series; and 747-200B, -200C, and -200F series airplanes. Should J.R.G. Design apply at a later date for a type certificate change for these airplane models incorporating the same novel or unusual design feature, these special conditions would apply to those airplanes as well, under the provisions of § 21.101(a)(1), Amendment 21-69, effective September 16, 1991.

This action affects only certain novel or unusual design features on Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes. It is not a rule of general applicability and affects only the applicant which applied to the FAA for approval of these features on the airplane. The FAA has determined that notice and opportunity for public comment are unnecessary, because the FAA has provided previous opportunities to comment on substantially identical special conditions and has fully considered and addressed all the substantive comments received. The FAA is satisfied that new comments are unlikely and finds, therefore, that good cause exists for making these special conditions effective upon issuance.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Boeing Model 747SP series; 747-100 series; and 747-200B, -200C, and -200F series airplanes.

1. Protection From Unwanted Effects of High-Intensity Radiated Fields (HIRF). Each electrical and electronic system that performs critical functions must be designed and installed to ensure that the operation and operational capability of these systems to perform critical functions are not adversely affected when the airplane is exposed to high-intensity radiated fields.

2. For the purpose of these special conditions, the following definition applies: Critical Functions : Functions whose failure would contribute to or cause a failure condition that would prevent the continued safe flight and landing of the airplane.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain Aerospatiale Model ATR42-200, -300, -320, and -500 series airplanes; and Model ATR72-102, -202, -212, and 212A series airplanes was published in the Federal Register on February 21, 2003 (68 FR 8477). That action proposed to require modification of the flight attendant's seat located in the front of the cabin, and follow-on actions.

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.

We have revised the applicability listed in Table 1 in this final rule to more clearly identify those airplanes affected by this AD.

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

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

The FAA estimates that approximately 80 airplanes of U.S. registry will be affected by this AD, that it will take approximately 1 work hour per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Required parts will cost approximately $1,786 per airplane. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $147,680, or $1,846 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain BAE Systems (Operations) Limited Model BAe 146 series airplanes was published in the Federal Register on March 12, 2003 (68 FR 11760). That action proposed to require modification of the flight annunciator box.

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

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

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency, this final rule retains the language of the NPRM regarding that material.

The FAA estimates that 20 airplanes of U.S. registry will be affected by this AD, that it will take approximately 2 work hours per airplane to accomplish the modification, and that the average labor rate is $60 per work hour. Required parts will cost approximately $250 per airplane. Based on these figures, the cost impact of the AD on U.S. operators is estimated to be $7,400, or $370 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an airworthiness directive (AD) that is applicable to certain EMBRAER Model EMB-145 series airplanes was published as a supplemental notice of proposed rulemaking (NPRM) in the Federal Register on June 5, 2000 (65 FR 35590). That action proposed to require a one-time ultrasonic inspection of the maneuvering actuator piston rod of the main landing gear (MLG) to ensure adequate wall thickness of the piston rods, and replacement of any discrepant piston rod with a new piston rod.

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

Several commenters request that the supplemental NPRM be revised to allow credit for work accomplished in accordance with the original version of EMBRAER Service Bulletin 145-32-0031, dated July 3, 1998; and Change 01, dated December 8, 1998. The commenters note that, if the inspection and related actions have been accomplished in accordance with either of those service bulletin versions, no additional work would be necessary to accomplish the actions specified in Change 02 of the service bulletin. The commenters suggest that failure to include this credit provision in the AD could unnecessarily require operators to request an alternative method of compliance to demonstrate compliance with the requirements of the AD.

The FAA agrees. The procedures described in the original issue and Change 01 of EMBRAER Service Bulletin 145-32-0031 are essentially the same as those described in Change 02. Therefore, the original issue and Change 01 of the service bulletin are also acceptable for compliance with this AD. Paragraph (a) of this final rule has been revised accordingly.

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

On July 10, 2002, the FAA issued a new version of 14 CFR part 39 (67 FR 47997, July 22, 2002), which governs the FAA's airworthiness directives system. The regulation now includes material that relates to altered products, special flight permits, and alternative methods of compliance. However, for clarity and consistency in this final rule, we have retained the language of the NPRM regarding that material.

The FAA estimates that 33 airplanes of U.S. registry will be affected by this proposed AD, that it will take approximately 1 work hour per airplane to accomplish the required actions, and that the average labor rate is $60 per work hour. Based on these figures, the cost impact of this AD on U.S. operators is estimated to be $1,980, or $60 per airplane.

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

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

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

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that is applicable to General Electric Company (GE) CF6-80A1/A3 and CF6-80C2A PMC series turbofan engines was published in the Federal Register on June 21, 2002 (67 FR 42202). That action proposed to require performing either a directional pilot valve (DPV) pressure switch moisture purge procedure and an operational check of the fan reverser, or replacing the DPV assembly with a serviceable assembly and performing an operational check of the fan reverser. Thereafter, that action proposed to require one of these actions on a repetitive basis in accordance with Middle River Aircraft Systems Alert Service Bulletins (ASBs) CF6-80A1/A3 SB 78A4030, dated April 4, 2002 or CF6-80C2A PMC SB 78A1118, dated April 4, 2002.

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

One commenter requests that the applicability statement be revised to reference the left-hand fan reverser halves associated with the engines instead of the engine models themselves. The commenter believes that the DPV assembly is not a part of the engine, but is instead a part of the left-hand fan reverser half. The commenter notes the fact that the reverser halves and engines can be removed or installed separately.

The FAA does not agree. The FAA acknowledges that in service the engines and fan reversers can be separated, with the possibility of reversers remaining installed on-wing, while different engines are installed. However, the fan reverser assembly and, therefore, the DPV are part of the engine (14 CFR part 33) type design. The applicability to the engine model is, therefore, appropriate. No changes will be made to the AD as a result of this comment.

One commenter requests that isopropyl alcohol be allowed as an acceptable alternate to the acetone solvent listed in the consumables of the ASBs as the fluid used for purging moisture from the DPV pressure switch assemblies. The commenter notes that some airports may restrict the use of acetone. The commenter also notes that the DPV assembly manufacturer has agreed that alcohol is an acceptable alternate for acetone for the purposes of accomplishing the moisture purge service bulletins.

The FAA agrees that isopropyl alcohol is an acceptable alternate for acetone for this application. The FAA, GE, and the component manufacturer, previously identified this issue and the ASBs were revised on August 23, 2002, to allow the use of isopropyl alcohol. The compliance section of this final rule AD has been revised to add Revision 1 to each of the ASBs.

One commenter requests that deactivation of the fan reverser be allowed as an alternative to replacement with a serviceable DPV. The commenter sites a previous AD (99-18-19) that allowed deactivation instead of a DPV leak check inspection.

The FAA agrees and the final rule is revised to allow deactivation. Limitations for operation with one or more reversers deactivated have also been added and are consistent with the previous AD.

One commenter requests that the description of the failure sequence in the discussion section of the NPRM preamble be reworded to clarify that an additional failure is required in order for the undetectable DPV pressure switch freezing failure to result in an inadvertent deployment (IAD). The commenter believes that the current statement is misleading. The commenter believes that in addition to the pressurization failure, a directional failure is required before an IAD can occur.

The FAA does not agree. While the FAA agrees that the wording could have been clearer, the requested change does not affect the conclusion that an unsafe condition has been identified. In addition, the Discussion section details are not repeated in the final rule after an NPRM, and therefore, the AD remains unchanged as a result of this comment.

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 described previously. The FAA has determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

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

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 the 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 by contacting the Rules Docket at the location provided under the caption ADDRESSES.

The Commission issued the Appliance Labeling Rule in 1979, 44 FR 66466 (Nov. 19, 1979) (“Rule”), in response to a directive in the Energy Policy and Conservation Act of 1975 (“EPCA”) (42 U.S.C. 6294). EPCA also requires the Department of Energy (“DOE”) to develop test procedures that measure how much energy certain appliances use, and to determine the representative average cost a consumer pays for the different types of available energy.

The rule covers, among other things, eight categories of major household appliances: refrigerators and refrigerator-freezers, freezers, dishwashers, clothes washers, water heaters, room air conditioners, furnaces, and central air conditioners. 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, 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 similar to the labeled model.

The rule requires manufacturers, after filing an initial report, to report annually the estimated annual energy consumption or energy efficiency ratings for the appliances derived from tests performed pursuant to the DOE test procedures. 16 CFR 305.8(b). Because manufacturers regularly add new models to their lines, improve existing models, and drop others, the database from which the ranges of comparability are calculated is constantly changing. Under section 305.10 of the rule, to keep the required information on labels consistent with these changes, the Commission publishes new ranges (but not more often than annually) if an analysis of the new information indicates that the upper or lower limits of the ranges have changed by more than 15%. Otherwise, the Commission publishes a statement that the prior ranges remain in effect for the next year.

New energy conservation standards and a new DOE test procedure for clothes washers will become effective on January 1, 2004. The new energy conservation standard requires that all new residential clothes washers manufactured after January 1, 2004, be 22% more efficient than today's minimally compliant clothes washer. 1 Accordingly, the 2004 energy standard will render a substantial portion of the existing clothes washer market obsolete.

The new DOE test procedure for clothes washers, which also will become effective on January 1, 2004, is found at 10 CFR part 430, subpart B, Appendix J1. 2 Application of the new test procedure (sometimes referred to as the “J1” test or the “Modified Energy Factor” test) will likely produce energy consumption figures different from those yielded by the old (“J”) test procedure (10 CFR part 430, subpart B, Appendix J). 3 Because these test results are used to determine energy use information that appears on the FTC EnergyGuide label, consumers may not be able effectively to compare the energy performance of clothes washers if the labels are based on the two different test procedures.

To ease the transition to the new energy efficiency standard and new (J1) test procedure, AHAM  4 wrote to FTC staff on February 7, 2003, requesting permission to begin using that test for labeling clothes washers during 2003, before the test becomes effective. In addition, AHAM's letter requests that the Commission allow its members to provide special wording on the EnergyGuide labels for these models to help consumers in distinguishing washers tested under the new (J1) procedure from those tested under the old (J) procedure ( see Prototype Label 2 at the end of this document). AHAM proposed a modified label that would display a banner across the top stating: “This Model has been Tested to the 2004 Test Procedure. Compare only with Models with this Notice.” AHAM requested that the Commission allow its members to begin using the new (J1) test and modified labels on May 1, 2003, and that the labeling changes be made “permanent.” 5 To grant AHAM's request, the Commission would have to grant an exemption from certain EnergyGuide testing and labeling requirements for the remainder of this year and issue rule amendments to make the requested labeling changes a permanent requirement for all manufacturers after January 1, 2004.

AHAM submitted its request because it asserts that the transition to clothes washers compliant with the new 2004 energy efficiency standard and new test procedure, with respect to testing and labeling, could be unduly burdensome to manufacturers and confusing to consumers. According to AHAM, there will be hundreds of new energy efficient models introduced throughout the course of 2003. Under current requirements, manufacturers will have to test and rate these new models first under the old (J) procedure for 2003, and then again under the new (J1) procedure in order to distribute them in 2004. AHAM stated that, since several samples of each basic model need to be tested to determine statistically valid ratings, such duplicative testing would result in tremendous laboratory and manufacturer staff resources for hundreds of new models. Also, AHAM states that retail floor models are not changed frequently. Thus, without action by the FTC, retail display units for new models introduced this year will have energy labels based on the old (J) test well into 2004 and beyond. AHAM is concerned that these display units could be very confusing and misleading as consumers seek to compare units tested under different procedures in a single showroom without any notice that differences exist.

In an April 3, 2003, document (68 FR 16231), the Commission sought comments on AHAM's proposal. The proposal raised two procedural matters: (1) A request for an exemption from certain testing and labeling requirements for clothes washers from May through December 31, 2003 (to permit testing and labeling pursuant to the new (J1) test); and (2) a proposed “permanent” rule change, effective January 1, 2004, to conform existing label content and format requirements to label changes permitted by the 2003 exemption.

The proposed exemption implicated several provisions of the Appliance Labeling rule. The rule requires that, for purposes of the EnergyGuide label, manufacturers use the estimated annual energy consumption as derived from the DOE clothes washer test procedures in 10 CFR part 430 ( see 16 CFR 305.5(a) and 305.11(a)(5)(i)(E)). Because the new (J1) test for clothes washers will not become effective until January 1, 2004, the current rule does not authorize the use of that test for energy consumption information on EnergyGuide labels until that date. By granting the requested exemption, the Commission would allow manufacturers to begin using the new test results on EnergyGuide labels before 2004. In addition, the rule does not allow any marks or identification other than those specified in the rule to appear on the label except for some limited exceptions not applicable here ( see 16 CFR 305.11(a)(5)(i)(K)). Accordingly, absent an exemption, the rule does not allow the kind of explanatory information proposed by AHAM.

In the April 3, 2003, document, the Commission indicated that, by granting the exemption, it is probable that many new clothes washers distributed for sale in the United States for the remainder of 2003 would have labels containing the proposed advisory language that: “This Model has been Tested to the 2004 Test Procedure. Compare only with Models with this Notice.” Once this change is made to EnergyGuide labels on units distributed in 2003, a return to the conventional label in the future may cause consumer confusion because the units with the modified label will stay on showroom floors into 2004 and beyond. Given these considerations, AHAM asked the Commission to make its proposed label changes permanent. The Commission proposed that the advisory language required by the rule after January 1, 2004, should be identical to that on the label during the exemption period. The Commission sought public comment on a proposed rule change that would incorporate AHAM's suggested label changes and require these changes for all clothes washers distributed for sale in the United States beginning January 1, 2004.

The Commission received four comments in response to the April 3, 2003, document. 6 The three industry comments (from Alliance, Whirlpool, and AHAM) supported the proposed conditional exemption and rule change. AHAM stated that, “early compliance with J1 labeling requirements in 2003 is critical to the efficiency of testing and production as the industry transitions to new washer standards by the end of 2003.” 7 Whirlpool echoed AHAM's comment, adding that, without the conditional exemption, it would be not be able “to meet existing commitments to trade partners.” 8 These three commenters also supported the proposal to make the changes to the EnergyGuide label permanent. The fourth commenter, NRCan (the agency responsible for appliance labeling in Canada), raised concerns about the impact of the proposal on adjoining labels bearing both the U.S. EnergyGuide and the Canadian “EnerGuide” label (as allowed by the Commission's rule). An analysis of specific issues raised by the comments follows:

The Commission requested comments on whether the differences between the results yielded by the new (J1) and old (J) tests are significant enough to warrant special advisory language on the EnergyGuide labels. The Commission also asked whether one test yields significantly higher or lower results than the other. The three industry comments indicated that the differences were significant enough to warrant the change. Alliance stated that the tests yielded a 25% difference for one of its models. 9 Whirlpool and AHAM commented that the new (J1) test results are generally lower than the older (J) test results and the differences could be as much as 40%. 10

According to the commenters, the differences in energy use results yielded by the two tests can be significant. Given this information, we believe the explanatory text on the labels is appropriate to aid consumers in distinguishing models tested under the two procedures. The Commission notes that DOE periodically modifies the test procedure for covered products and such changes can yield different test results for the same model. In the past, the Commission has not required additional information on the EnergyGuide label in response to test procedure changes. In this case, however, there are special circumstances that, in the Commission's view, warrant the explanatory language as requested by AHAM. First, because the new conservation standard will become effective on the same date as the new test procedure, a large number of new models will appear on the market over a short period of time in response to the more stringent efficiency standards. In addition, the differences between the results of the old and new test procedures could be quite substantial in this case, up to 40% as indicated by the industry comments. Finally, because the exemption will allow manufacturers to begin using the new (J1) test results for labeling early, manufacturers will distribute new products with labels based on the new test while they will continue to distribute older products with labels reflecting the old test. Accordingly, the transition between the old and new labels in showrooms will likely be longer than is usually the case when DOE amends a test procedure. Considering all these factors, the Commission believes that explanatory language as suggested by AHAM is appropriate.

The Commission solicited comments on the proposed changes to the label, such as the content, size, and placement of the modified language on the EnergyGuide. The Commission asked whether the proposed language on the EnergyGuide label will help consumers in their purchasing decisions, or cause undue confusion. In addition, commenters were asked whether the reference to the year “2004” on the label will create confusion in subsequent years if the proposed change becomes a permanent fixture on the label and whether the explanatory language should be required on both the top and the bottom of the label. The Commission sought comment on alternatives to the proposed advisory language, such as using the term “J1” or “Modified Energy Factor” in lieu of “2004” in describing the test.

The three industry comments stated that the proposed changes are appropriate and that the changes to the EnergyGuide label will help consumers. Whirlpool stated that there will be less need for dealers to “refloor” model units and less confusion for “energy conscientious consumers when selecting new appliances.” 11 The industry commenters also preferred the reference to “the 2004 procedure” over other descriptors such as “J1” or “Modified Energy Factor” because consumers would have “no clue” as to the meaning of these latter terms. 12 They did not believe it was necessary to place the explanatory language on the bottom of the label (in addition to the statements proposed for the top and middle of the label). Whirlpool wrote that such information would be redundant for consumers. 13 Finally, AHAM and Alliance requested that the size of the new label be 7 3/8 inch (18.73 cm.) as currently required by the Rule and not 8 inches (20.32 cm.) as proposed by the Commission. 14 Alliance suggested that the use of a 7 3/8 inch (18.73 cm.) label can be accomplished by not incorporating the proposed text in the middle of the label. 15

The Commission agrees with the commenters that the “2004” language is preferable to alternatives such as “J1” and “Modified Energy Factor.” It is possible that, in later years, the reference to “2004” on the label may raise questions for consumers. Ultimately, however, we do not believe that this reference will have a significant impact on consumers' ability to compare clothes washer energy use because the relevant energy use and operating cost information will be clearly marked on the label. Accordingly, we have retained the reference to “2004” in the explanatory language for the final rule.

The Commission recognizes that it may not be desirable to retain this “2004” reference on the clothes washer labels indefinitely. Although the explanatory language will aid consumers during the upcoming transition period, the language will eventually become unnecessary because all models will carry the same label. The Commission may consider eliminating the special advisory language from the rule in the future. Each year, the Commission analyzes energy use information submitted for all clothes washers sold in the United States to determine whether the ranges of comparability for the EnergyGuide labels should change. If the Commission determines to amend the ranges in a given year, new labels printed as a result will display different ranges and use updated information to calculate operating costs. Accordingly, if there is perceived need to discontinue the explanatory statements on the labels in the future, the issuance of new ranges could provide the Commission with the opportunity to consider eliminating the advisory language published here.

The Commission has decided to make minor revisions to the proposed wording of the explanatory language. Instead of stating in the banner on top of the label that, “This Model has been Tested to the 2004 Test Procedure. Compare only with Models with this Notice,” the Commission believes that it is preferable to state, “This model has been tested using the 2004 test procedure. Compare only with models displaying this statement.” Similarly, the Commission has changed the explanatory text in the middle of the label to read: “Compare the energy use of this clothes washer only with models tested using the 2004 test procedure.” These modifications replace the phrase “Tested to the” with “tested using the” (emphasis added). In addition, the phrase “with this Notice” in the top banner has been changed to “displaying this statement.” The final language also eliminates stray capitalization that appeared in the proposed language. The Commission believes these minor changes will make it easier for consumers to understand the intended message.

Finally, some commenters stated that the conventional size label (7 3/8 inches; 18.73 cm.) should be used for the exemption and final rule instead of an 8 inch (20.32 cm.) label as proposed. Upon further review, the existing label size (7 3/8 inch; 18.73 cm.) will accommodate the additional banner. We see no significant benefit to requiring the proposed 8 inch (20.32 cm.) label instead of the conventional 7 3/8 inch (18.73 cm.) label. The Commission, however, does not agree with Alliance that the modified language in the middle of the label should be removed. This language in the middle of the label reinforces the message provided by the explanatory information in the top banner. Using existing font and format requirements for the EnergyGuide label, the conventional (7 3/8 inch; 18.73 cm.) label can accommodate the explanatory language at the top and in the middle of the label (as shown in Prototype Label 2).

The Commission asked whether the implementation of AHAM's proposal would cause consumer confusion for those units with EnergyGuide labels adjoining energy labels required by Mexico or Canada. Manufacturers using such joint labels generally print them on hang tags with the U.S. label on one side and the Canadian label on the other. NRCan raised concerns about the impact of the proposal for consumers examining these adjoining labels. Beginning in 2004, NRCan will require an equivalent of the J1 test for labeling purposes. That agency, however, may not have time to harmonize fully with the FTC's exemption and rule if the changes are implemented as proposed before then. Therefore, NRCan is concerned that there may be confusion if both labels do not report the same information on both sides. NRCan indicated, however, that it has discussed options with the Canadian Appliance Manufacturers Association and is willing to work to identify non-regulatory approaches to this issue. 16 Without such a resolution, manufacturers would continue to use the Canadian equivalent of the old (J) test for new models sold in Canada until the end of this year.

The other commenters believed that the proposal would not cause confusion where adjoining labels are used. AHAM stated that the EnergyGuide label is discernable from that of Mexico or Canada because it is entirely in English, has a unique format, and clearly states that the results are based on U.S. government tests. In addition, AHAM suggested that the proposed J1 label would make it clear that the label should only be compared with other labels bearing the same message. 17 Alliance asserted that, “[t]he Commission's first priority is to provide accurate information to U.S. consumers, not withhold action or information because of potential impacts to consumers in neighboring countries.” In its view, any confusion resulting from the change would be far less than the confusion that would result if the Commission does not issue the proposed exemption and amendment. 18

The Commission understands NRCan's concerns about the use of new (J1) test data on labels and the advisory language related to that test on adjoining U.S.-Canadian labels. We do not, however, believe that these concerns warrant a change to the proposed conditional exemption and rule amendments. Beginning January 1, 2004, all models distributed in the U.S. and Canada will display labels based on the same test. Before that time, it is unclear whether manufacturers will distribute new models in Canada if, in doing so, they will have to conduct the same double testing they have sought to avoid through their petition to the Commission. In addition, NRCan, as suggested in its comment, may identify a “non-regulatory” solution that allows manufacturers to use the J1 test for labels on products sold in Canada and thus eliminate these concerns altogether.

Even assuming some new models are distributed this year bearing the joint label, the Commission does not expect that differences between the Canadian and U.S. labels will significantly impede consumers' ability to compare the energy use of competing products. Since 1996, the Commission's rule has allowed manufacturers to print the EnergyGuide label directly adjoining the Canadian EnerGuide. See 16 CFR 305.11(5)(i)(I). The U.S. EnergyGuide label contains operating cost information not found on the Canadian EnerGuide label. In addition, range of comparability information on the FTC EnergyGuide label may not be the same as that on the Canadian EnerGuide labels. We have no evidence that these differences have caused confusion. As Alliance suggests in its comments, the EnergyGuide's reference to U.S. government tests alerts consumers that the label is intended for U.S. consumers. 19 In the long term, the Commission believes it is important to harmonize the U.S. label with the Canadian label as much as possible. Given the relatively short duration of the exemption period and for the other reasons discussed above, however, the Commission is not requiring any specific conditions for the exemption with regard to adjoining labels.

The Commission asked for comments on the economic impact of the proposed rule and conditional exemption, including impacts on small business. AHAM stated that the proposals would impose no additional burdens on manufacturers and would assist manufacturers in meeting DOE efficiency standards by January 1, 2004. 20 Whirlpool added that it would suffer serious consequences if the FTC failed to implement these changes by early May. 21 Alliance indicated that the proposal would reduce a significant burden on manufacturers. It estimated that the proposal would save that company 35 working days of one laboratory technician dedicated to DOE energy testing. 22

The manufacturers have described the burdens they are seeking to avoid through the requested exemption. The Commission believes that issuance of the exemption and final rule will help to avoid those burdens while, at the same time, minimizing any consumer confusion associated with the transition from the old Appendix J test procedure to the new Appendix J1 procedure.

The Commission has considered the comments received and has decided to issue the conditional exemption and amendments as detailed in this section. The Commission believes that there are benefits to allowing manufacturers to begin changing over to the new labels and test results at this time. The exemption and rule change will allow manufacturers to avoid testing their new products multiple times pursuant to two test procedures for the purposes of FTC labeling. 23 In addition, consumers will obtain information based on the new test sooner. The Commission also believes that the changes to the label will minimize consumer confusion resulting from the exemption and transition to the new test by alerting consumers that the energy use information on some labels is derived from a new test procedure.

The Commission grants AHAM's request for an exemption from the requirements in 16 CFR 305.5(a) and 305.11(a) only to the extent required to allow manufacturers to:

(1) Use the test procedure in 10 CFR part 430, subpart B, Appendix J1 for determining the energy use figure printed on EnergyGuide labels of clothes washers distributed between June 11, 2003, and December 31, 2003; 24 and

(2) For such models, use EnergyGuide labels that contain the following modifications to the format and content requirements in 16 CFR 305.11, as illustrated in Prototype Label 2 at the end of this document:

(a) The use of the statement “Compare the energy use of this clothes washer only with other models tested using the 2004 test procedure” in lieu of the statement “Compare the Energy Use of this Clothes Washer with Others Before You Buy”; and

(b) The use of the statement “This model has been tested using the 2004 test procedure. Compare only with models displaying this statement.” in a 10/16 inch (1.59 cm.) in height, process black bar across the top of the label.

The Commission grants the exemption with the following conditions: (1) That any manufacturers using this exemption must use it for all clothes washer models introduced between June 11, 2003, and December 31, 2003 (they may also use it for existing models that meet the new conservation standard), and (2) the modified EnergyGuide label must be used if the new (J1) test is used to derive energy use information on the EnergyGuide label for clothes washers. The manufacturers remain obliged to comply with all other Rule requirements. Manufacturers not specifically named in AHAM's request may use this exemption as long as they follow the conditions specified by the Commission. 25

After considering the comments, the Commission has determined to issue the final rule as described in this section. To avoid confusion that may result from switching back to the conventional label after the exemption period, the Commission believes that is preferable to amend the Rule to require the explanatory language on EnergyGuide labels for all models beginning January 1, 2004. These label changes are identical to those allowed by the conditional exemption. The final amendments published here will minimize consumer confusion that could result from a return to the conventional label at the end of the exemption period.

Consistent with the conditional exemption, the final rule does not require an 8 inch label as proposed but instead retains the 7 3/8 inch (18.73 cm.) length currently required by the Rule. In addition, the final rule incorporates the minor wording and format changes to the explanatory statements described in the comment analysis and in the description of the conditional exemption. The final rule changes are printed at the end of this document. All manufacturers must follow these requirements beginning January 1, 2004. 26

Under section 22 of the FTC Act, 15 U.S.C. 57b, the Commission must issue a regulatory analysis for a proceeding to amend a rule only when it: (1) Estimates that the amendment will have an annual effect on the national economy of $100,000,000 or more; (2) estimates that the amendment will cause a substantial change in the cost or price of certain categories of goods or services; or (3) otherwise determines that the amendment will have a significant effect upon covered entities or upon consumers. The Commission has determined that the exemption and amendments to the rule will not have such effects on the national economy, on the cost of covered products, or on covered parties or consumers.

The Regulatory Flexibility Act (“RFA”), 5 U.S.C. 601-612, requires that agencies conduct analyses of the anticipated economic impact of proposed amendments on small businesses. The purpose of a regulatory flexibility analysis is to ensure that the agency considers impact on small entities and examines regulatory alternatives that could achieve the regulatory purpose while minimizing burdens on small entities. Section 605 of the RFA, 5 U.S.C. 605, provides that such an analysis is not required if the agency head certifies that the regulatory action will not have a significant economic impact on a substantial number of small entities.

There are approximately 20 manufacturers of clothes washers sold in the United States. Most of these manufacturers are relatively large. 27 Because the clothes washer requirements of the Appliance Labeling rule cover a limited number of manufacturers, most of which are large, the Commission does not believe the proposed amendments or exemption will affect a substantial number of small businesses. In any event, the proposed amendments and exemptions are unlikely to have a significant economic impact upon such entities, if any. Specifically, the proposed rule and exemption involve minor text changes to labels already required by the rule. The content of these labels must be changed in response to new ranges of comparability published by the Commission from time to time. Moreover, for the reasons explained earlier, the final rule amendments and exemption are expected to lessen the compliance burdens that would be imposed on regulated entities if they were not permitted to label their products in accordance with the 2004 test procedures before those procedures officially take effect. In the Commission's view, the amendments and exemption should not have a significant or disproportionate impact on the costs of small manufacturers and retailers.

Based on available information, therefore, the Commission certifies that these amendments to the Appliance Labeling rule and the issuance of the requested exemption will not have a significant economic impact on a substantial number of small businesses.

In a 1988 notice (53 FR 22113), the Commission stated that the Rule contains disclosure and reporting requirements that constitute “information collection requirements” as defined by 5 CFR 1320.7(c), the regulation that implements the Paperwork Reduction Act. 28 The Commission noted that the rule had been reviewed and approved by the Office of Management and Budget (“OMB”) and has been assigned OMB Control No. 3084-0068 with respect to the rule's recordkeeping and reporting requirements until September 30, 2004, subject to further renewal. The exemption and amendments issued in this document do not change the substance, frequency of the recordkeeping, disclosure, or reporting requirements and, therefore, do not require further OMB clearance. 29

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. In keeping with the requirements of 5 U.S.C. 553(d)(3), the Coast Guard also finds that good cause exists for making this regulation effective less than 30 days after publication in the Federal Register . The precise location of the event necessitating promulgation of this safety zone and other logistical details surrounding the event were not finalized until a date fewer than 30 days prior to the event. Delaying the effective date of this rule would be contrary to the public interest because doing such would prevent the Coast Guard from maintaining the safety of the participants of the event and users of the waterway.

The Coast Guard is establishing a temporary safety zone on the navigable waters of the Colorado River in Laughlin, Nevada in support of the Laughlin 4th of July fireworks show. The fireworks will be launched from an area on land, however, the fallout area will be over a section of the Colorado River and a safety zone is necessary to provide for the safety of the spectators and users of this waterway.

The Coast Guard proposes to establish this temporary rule to provide for the safety of the participants, spectators and other users of the waterways. The temporary safety zone is specifically defined as 600 yards around the point 35°09.270″ N, 114°34.222″ W. Persons and vessels will be prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

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

Due to the temporary safety zone's short duration of one hour for two days, its limited scope of implementation, and because vessels will have an opportunity to request authorization to transit, the Coast Guard expects the economic impact of this rule to be so minimal that full regulatory evaluation under the regulatory policies and procedures of the DHS is unnecessary.

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

For the same reasons set forth in the above Regulatory Evaluation, the Coast Guard certifies under 5 U.S.C. 605(b) that this rule is not expected to have a significant economic impact on any substantial number of entities, regardless of size.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), the Coast Guard wants to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process. If your small business or organization is affected by this rule and you have questions concerning its provisions or options for compliance, please contact Lieutenant Commander Rick Sorrell, U.S. Coast Guard Marine Safety Office San Diego at (619) 683-6495.

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction, from further environmental documentation.

Under figure 2-1, paragraph (34)(g), of the Instruction, an “Environmental Analysis Check List” and a “Categorical Exclusion Determination” are not required for this rule.

I. Background. Section 203.62 is corrected by redesignation of the second paragraph (d) “Guidance” as paragraph (e) and paragraph (e) “Guidance-transport of water” as paragraph (f) and paragraph (f) “Request for assistance” as paragraph (g).

Section 106(6) of the Copyright Act, title 17 of the United States Code, gives copyright owners of sound recordings an exclusive right to perform their copyrighted work publicly by means of a digital audio transmission. This right is limited by section 114(d), which allows certain noninteractive digital audio services to transmit sound recordings under a compulsory license, provided that the services pay a reasonable royalty fee and comply with the terms of the statutory license. Among the categories of services that may use the section 114 license are preexisting subscription services  1 of which there are only three: Digital Cable Radio Associates, now known as Music Choice; DMX Music, Inc. (“DMX”); and Muzak, L.P. (“Muzak”).

In 1998, the Librarian of Congress adopted final rates and terms applicable to the preexisting services after a hearing before a copyright arbitration royalty panel (“CARP”). See 63 FR 25394 (May 8, 1998). In that proceeding, the parties proposed a term which gave the RIAA the responsibility for collecting and distributing the royalty fees to all copyright owners. Id. at 25397. The Librarian adopted this term, then crafted additional regulations that afforded copyright owners a means to verify the accuracy of the royalty payments made by the RIAA collective, 2 established the value of each performance, specified the nature of the costs that RIAA may deduct from the royalty fees prior to distribution, and set forth a procedure for handling royalty fees in the case where the collective is unable to identify or locate a copyright owner who is entitled to receive royalties collected under the statutory license.

RIAA appealed both the rate and the additional terms announced in the Librarian's determination and final order. See, Recording Industry Ass'n v. Librarian of Congress, 176 F.3d 528 (D.C. Cir. 1999). The United States Court of Appeals for the District of Columbia Circuit upheld the rate and found that the Librarian had the authority to impose additional terms on copyright owners or their agents. However, it remanded for further consideration certain terms imposed on RIAA under 37 CFR 260.2(d), 260.3(d), 260.6(b), and 260.7, because the CARP had not considered these issues, leaving the record devoid of any evidence upon which to fashion any terms concerning the collection and distribution of the royalty fees. Id. at 536.

In 2001, RIAA petitioned the Copyright Office to adopt new terms that would govern the RIAA collective. These terms were to be adopted pursuant to § 251.63(b) which allows the Librarian of Congress to adopt proposed terms that are the result of settlement negotiations, provided that no person with a substantial interest and an intent to participate in a CARP proceeding files an objection.

Accordingly, the Copyright Office published the proposed terms in the Federal Register and requested public comment. 66 FR 38226 (July 23, 2001). In response to this notice, the American Federation of Musicians (“AFM”) and the American Federation of Television and Radio Artists (“AFTRA”) filed a Notice of Intent to Participate and objections to certain of the proposed terms. Shortly thereafter, RIAA began discussions with AFTRA and AFM regarding their objections, and the matter was held in abeyance, pending the outcome of those discussions.

In the meantime, Congress passed the Small Webcaster Settlement Act of 2002 (“SWSA”), Public Law 107-321, 116 Stat. 2780, which, among other things, amended 17 U.S.C. 114(g) in two important ways that bear directly on two key issues raised in this proceeding. First, the SWSA provides for direct payment to featured recording artists and to the administrators of the escrow accounts provided for in 17 U.S.C. 114(g)(2)(B)&(C). Second, the act allows a designated agent, prior to the distribution of the royalty receipts, to deduct reasonable costs incurred by that agent in the administration of those receipts, including, but not limited to, costs associated with the collection and distribution of the royalty fees and the costs incurred in participating in negotiations or arbitration proceedings under sections 112 and 114.

Because of these changes in the law, RIAA revised its proposed amendments to 37 CFR part 260 to conform the terms in question to the new law and, in doing so, it addressed the concerns of AFM and AFTRA. However, the proposed rules could not be adopted until all interested parties had an opportunity to comment. Therefore, pursuant to § 251.63(b) of the CARP rules, the Library published in the Federal Register the proposed terms and sought comment from any party with a substantial interest in this proceeding. 68 FR 19482 (April 21, 2003).

Having received no objections to the recently proposed terms, the Librarian is adopting the proposed amendments as final regulations. The proposed terms shall govern SoundExchange, the collecting rights entity that was formed from the designated RIAA collective, in its capacity as the sole agent designated to receive royalty payments from the three subscription services that were parties to this proceeding. Terms governing the administrative functions of any future collective or the designation of alternative agents shall be decided in future rate adjustment proceedings either through negotiations or after a hearing before a CARP based upon a fully developed written record. See, e.g. , 67 FR 45239 (July 8, 2002).

Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This section provides additional information by addressing the following questions:

Section 110 of the Clean Air Act (CAA) requires states to develop air pollution regulations and control strategies to ensure that state air quality meets the national ambient air quality standards established by EPA. These ambient standards are established under section 109 of the CAA, and they currently address six criteria pollutants. These pollutants are: carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.

Each state must submit these regulations and control strategies to us for approval and incorporation into the Federally-enforceable SIP.

Each Federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin. These SIPs can be extensive, containing state regulations or other enforceable documents and supporting information such as emission inventories, monitoring networks, and modeling demonstrations.

In order for state regulations to be incorporated into the Federally-enforceable SIP, states must formally adopt the regulations and control strategies consistent with state and Federal requirements. This process generally includes a public notice, public hearing, public comment period, and a formal adoption by a state-authorized rulemaking body.

Once a state rule, regulation, or control strategy is adopted, the state submits it to us for inclusion into the SIP. We must provide public notice and seek additional public comment regarding the proposed Federal action on the state submission. If adverse comments are received, they must be addressed prior to any final Federal action by us.

All state regulations and supporting information approved by EPA under section 110 of the CAA are incorporated into the Federally-approved SIP. Records of such SIP actions are maintained in the Code of Federal Regulations (CFR) at Title 40, Part 52, entitled “Approval and Promulgation of Implementation Plans.” The actual state regulations which are approved are not reproduced in their entirety in the CFR outright but are “incorporated by reference,” which means that we have approved a given state regulation with a specific effective date.

Enforcement of the state regulation before and after it is incorporated into the Federally-approved SIP is primarily a state responsibility. However, after the regulation is Federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in section 304 of the CAA.

Missouri rule 10 CSR 10-2.280 and Missouri rule 10 CSR 10-5.320 relate to the control of emissions from Perchloroethylene Dry Cleaning Installations for the Kansas City and St. Louis areas, respectively. These rules had been approved by EPA as representing Reasonably Available Control Technology (RACT) in the Kansas City and St. Louis areas.

This revision to Missouri's SIP will rescind rules 10 CSR 10-2.280 and 10 CSR 10-5.320, which have been superseded by the state-adopted Maximum Achievable Control Technology (MACT) rule 10 CSR 10-6.075. The latter rule incorporates by reference the EPA rule, 40 CFR part 63, subpart M. As such, prior to this action, there were three Federally enforceable regulations for the Perchloroethylene Dry Cleaning Installations.

An EPA review concluded that the rescission of these two Missouri rules does not result in any increase in emissions. There is no relaxation of controls by rescinding rules 10 CSR 10-2.280 and 10 CSR 10-5.320. Sources subject to the rule must still meet a control technology at least as stringent as RACT. Therefore, there are no adverse impacts on the ability of the Kansas City and St. Louis areas to maintain the 1-hour ozone standard. The controls on subject dry cleaning installations will remain enforceable by the state under 10 CSR 10-6.075, and by EPA, under 40 CFR part 63, subpart M. Approval of this revision will eliminate redundancy and conflicting requirements.

The state submittal has met the public notice requirements for SIP submissions in accordance with 40 CFR 51.102. The submittal also satisfied the completeness criteria of 40 CFR part 51, appendix V. In addition, as explained above and in more detail in the technical support document which is part of this document, the revision meets the substantive SIP requirements of the CAA, including section 110 and implementing regulations.

We are approving the revision to rescind Missouri rule 10 CSRS 10-2.280, Control of Emissions from Perchloroethylene Dry Cleaning Installations and Missouri rule 10 CSR 10-5.320, Control of Emissions from Perchloroethylene Dry Cleaning Installations from the Missouri SIP.

We are processing this action as a final action because the revisions make routine changes to the existing rules which are noncontroversial. Therefore, we do not anticipate any adverse comments. Please note that if EPA receives adverse comment on part of this rule and if that part can be severed from the remainder of the rule, EPA may adopt as final those parts of the rule that are not the subject of an adverse comment.

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

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

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

The Congressional Review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 18, 2003. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

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 (NAIC 111)

• Animal production (NAIC 112)

• Food manufacturing (NAIC 311)

• Pesticide manufacturing (NAIC 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-2003-0155. 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 April 17, 2002 (67 FR 18894) (FRL-6830-5), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170), announcing the filing of a number of pesticide petitions by Monsanto, 600 13th St., NW., Suite 660, Washington, DC 20005. The notice included a summary of the petition prepared by Monsanto, the registrant. Comments received in the public docket with respect to the Notice of Filing were addressed in the final rule publication in the Federal Register of September 27, 2002 (67 FR 60934) (FRL-7200-2), and will not be presented again here in this final rule.

The petitions requested that 40 CFR 180.364 be amended by establishing a tolerance for residues of the herbicide glyphosate in or on corn, field, forage at 6 ppm; by reducing the tolerance on aspirated grain fractions from 200 ppm to 100 ppm. In addition, the Agency is taking this opportunity to change the commodity definition from aspirated grain fractions to grain, aspirated fractions; deleting the existing tolerance for soybean, aspirated grain fractions at 50.0 ppm since these soybean fractions are included in the “grain, aspirated fractions” tolerance described above; and by deleting the existing tolerance for animal, feeds, nongrass group, except alfalfa at 200 ppm, which is now included in the established tolerance for animal feed, nongrass, group at 400 ppm.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a tolerance for residues of glyphosate on grain, aspirated fractions at 100 ppm and corn, field, forage at 6.0 ppm. EPA's assessment of exposures and risks associated with establishing glyphosate tolerances for a number of feed commodities was performed previously and was presented in detail in the final rule on Glyphosate Pesticide Tolerances (67 FR 60934, September 27, 2002) (FRL-7200-2). Given that higher tolerances for glyphosate are currently established for other significant animal feed commodities, the dietary burden for cattle, poultry, and hogs will be unaffected by a glyphosate tolerance for aspirated grain fractions at 100 ppm and corn, field, forage at 6.0 ppm. EPA estimates a worst-case dietary burden for livestock animals by assuming an animal consumes dietary feeds bearing the highest permitted residues. In the case of glyphosate, the dietary feed bearing the highest permitted residue is alfalfa hay as the roughage component of the diet with a tolerance of 400 ppm whereas only 6 ppm of glyphosate is permitted in corn forage and 100 ppm in grain, aspirated fractions. Accordingly EPA's previous assessment of exposures and risks will not change. Based on these prior 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 glyphosate residues.

Adequate enforcement methods are available for analysis of residues of glyphosate in or on plant and livestock commodities. These methods include gas liquid chromatography (GLC) (Method I in Pesticides Analytical Manual (PAM) II; the limit of detection is 0.05 ppm) and high performance liquid chromatography (HPLC) with fluorometric detection. Use of the GLC method is discouraged due to the lengthiness of the experimental procedure. The HPLC procedure has undergone successful Agency validation and was recommended for inclusion in PAM II. A gas chromatography mass spectrometry (GC/MS) method for glyphosate in crops has also been validated by EPA's Analytical Chemistry Laboratory (ACL). Thus, adequate analytical methods are available for residue data collection and enforcement of the tolerances of glyphosate in/on aspirated grain, aspirated fractions and corn, field, forage. 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.

Codex and Mexican maximum residue limits (MRLs) are established for residues of glyphosate (glifosato) per se and Canadian MRLs are established for combined residues of glyphosate and AMPA in a variety of raw agricultural, processed, and animal commodities. Currently a relevant Codex MRL for maize forage is established at 1.0 ppm. No Canadian MRL is established for aspirated grain fractions or corn forage. The U.S. tolerance corn, field, forage at 6.0 ppm, cannot be harmonized with the Codex MRL for maize, forage at 1 ppm because the U.S. tolerance is based on higher application rates than those used in the residue studies previously considered by Codex.

Therefore, the tolerance is established for residues of glyphosate, in or on grain, aspirated fractions at 100 ppm and corn, field, forage at 6.0 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-2003-0155 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 August 18, 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-2003-0155, 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/Agriculture (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. 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-2003-0113. 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 3, 2001 (66 FR 22225) (FRL-6773-9), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a, as amended by FQPA (Public Law 104-170), announcing the filing of a pesticide tolerance petition (PP 1G6240), submitted by AgraQuest, Inc., 1530 Drew Avenue, Davis, CA 95616. This notice included a summary of the petition prepared by the petitioner AgraQuest, Inc. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Bacillus pumilus strain QST2808. Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of the FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, section 408(b)(2)(D) of the FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

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

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

Bacillus pumilus is a ubiquitous and naturally occurring bacteria found in soil. The results of the acute toxicology and pathogenicity studies required of the petitioner under section 408(d)(2)(A) of the FFDCA in support of its petition for a temporary exemption from the requirement of a tolerance for Bacillus pumilus strain QST2808 indicate negligible to no mammalian toxicity. In addition, no pathogenicity was observed in any of the tests conducted with the Bacillus pumilus strain QST2808 Technical product.

The toxicology and pathogenicity data generated by AgraQuest, Inc in support of this temporary exemption from the requirement of a tolerance are summarized below.

1. Acute oral toxicity and pathogenicity rats (OPPTS Harmonized Guideline 885.3050; Master Record Identification Number (MRID) 451366-04) . Fifteen male and fifteen female rats each were administered 4.1 x 10 9 cfu of Bacillus pumilus strain QST2808 Technical and observed for 14 days. Based on the data, Bacillus pumilus strain QST2808 does not appear to be toxic, infective, and/or pathogenic in rats, when dosed at 4.1 x 10 9 cfu/animal. Classification: Acceptable; Toxicity Category IV. (C. Etsitty's Memorandum to John L. Kough, dated 1/7/02 (hereinafter referred to as “BPPD Review - 1/7/02”)).

2. Acute dermal toxicity (OPPTS Harmonized Guideline 885.3100; MRID 451366-05) . Five male and five female rabbits were dermally treated with 2g/kg body weight Bacillus pumilus strain QST2808 Technical for 24 hours and observed for the following 14 days. The acute lethal dose (LD 50 ) is greater than 2,000 mg/kg. Classification: Acceptable; Toxicity Category III. (BPPD Review - 1/7/02).

3. Primary eye irritation (OPPTS Harmonized Guideline 870.2400; MRID 452679-01) . Three male rabbits each were administered 0.1 mL of QST2808 Technical in the everted lower lid of one eye and then observed for 72 hours. Based on the data, QST2808 Technical showed minimal effects to the eye. Classification: Acceptable; Toxicity Category IV. (BPPD Review - 1/7/02).

4. Acute injection toxicity/pathogenicity (OPPTS Harmonized Guideline 885.3200; MRID 451366-07) . Eighteen male and eighteen female rats each were dosed at 1.6 x 10 8 cfu Bacillus pumilus strain QST2808 Technical intravenously and monitored over a period of 28 days. A gross necropsy was performed on all rats. Based on the data, the test organism was not toxic, infective, or pathogenic to rats. Classification: Acceptable. (BPPD Review - 1/7/02).

5. Acute pulmonary toxicity/pathogenicity (OPPTS Harmonized Guideline 885.3150; MRID 451366-06) . Eighteen male and eighteen female rats each were administered 1.6 x 10 8 cfu Bacillus pumilus strain QST2808 Technical by a single intratracheal dosage and monitored over a period of 35 days for clinical signs of toxicity. Necropsy studies showed no significant signs of abnormalities due to the test organism. Based on the data, Bacillus pumilus strain QST2808 was not toxic, infective, and/or pathogenic to rats when dosed at 1.6 x 10 8 cfu/animal. Classification: Acceptable. (BPPD Review - 1/7/02).

6. Acute Inhalation toxicity (OPPTS Harmonized Guideline 870.1300) . Results of the acute pulmonary toxicity/pathogenicity (MRID 451366-06) performed with Bacillus pumilus strain QST2808 Technical indicate that it is not toxic, infective, and/or pathogenic to rats when dosed at 1.6 x 10 8 cfu/animal. For the purposes of this specific action, the Agency has determined that the acute pulmonary toxicity/pathogenicity data are adequate to support and/or fulfill this particular data requirement.

7. Primary dermal irritation (OPPTS Harmonized Guideline 870.2500; MRID 452679-02) . Each of three male adult rabbits were treated dermally with 0.5 mL QST2808 Technical for 4 hours and observed for the following 72 hours. Based on the data, no abnormal clinical signs were noted. Approximately 60 minutes after patch removal, very slight erythema was noted on one of the three rabbits with resolution by 24 hours. When dosed with QST2808 Technical at 0.5 mL/animal, QST2808 Technical was essentially non-irritating. Classification: Acceptable; Toxicity Category IV. (BPPD Review - 1/7/02).

8. Hypersensitivity incidents (OPPTS Harmonized Guideline 885.3400) . The registrant reported (November 1, 2000) no incidents to date.

9. Immune response . There is no information to suggest that Bacillus pumilus strain QST2808 has an effect on the immune system. The submitted toxicity/pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient (MRID 451366-04; 451366-06, and 451366-07).

Based on the data generated in accordance with the Tier I data requirements set forth in 40 CFR § 158.740(c), the Tier II and Tier III data requirements were not triggered and, therefore, not required in connection with this action. In addition, because the Tier II and Tier III data requirements were not required, the residue data requirements set forth in 40 CFR § 158.740(b) also were not required.

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).

Humans and animals are commonly exposed to Bacillus pumilus , a ubiquitous microorganism that inhabits soil. No toxicological endpoints were identified for Bacillus pumilus strain QST2808. The low toxicity and non-pathogenicity/infectivity of Bacillus pumilus strain QST2808 is demonstrated by the data summarized in Unit III of this action.

1. Food . While the proposed use pattern may result in dietary exposure with possible residues in or on agricultural commodities, negligible to no risk is expected for the general population, including infants and children, or animals because Bacillus pumilus strain QST2808 technical demonstrated no pathogenicity or oral toxicity at the maximum doses tested, as noted above in (Unit III).

2. Drinking water exposure . Most importantly, there is no evidence of adverse effects from oral, dermal, or inhalation exposure to this microbial agent. (See “Unit III. Toxicological Profile” above.) In addition, the potential for transfer of Bacillus pumilus strain QST2808 to surface or ground water during run-off associated with intended use applications is considered minimal to non-existent, due in part to its percolation through and resulting capture in soil. Accordingly, the use of this microbial pest control agent on terrestrial plants is not anticipated to negatively impact the quality of drinking water.

Based on the proposed use patterns, the potential of non-dietary exposures to Bacillus pumilus strain QST2808 pesticide residues for the general population, including infants and children, is unlikely. Accordingly, the Agency believes that the potential aggregate non-occupational exposure, derived from dermal and inhalation exposure through the application of Bacillus pumilus strain QST2808, should fall well below the currently tested microbial safety levels.

1. Dermal exposure . The potential for dermal exposure to Bacillus pumilus strain QST2808 pesticide residues for the general population, including infants and children, is unlikely because potential use sites are agricultural and horticultural. However, since Bacillus pumilus strain QST2808 is a naturally occurring bacteria in soil, there is a great likelihood of prior exposure for most, if not all individuals. Accordingly, the increase in exposure due to this proposed product would be negligible. Furthermore, and as demonstrated in Unit III of this action, the organism is of low dermal toxicity, the acute lethal dose (LD 50 ) is greater than 2,000 mg/kg, and the QST2808 Technical was essentially non-irritating (Toxicity Category IV). Accordingly, the risks anticipated for this route of exposure are considered minimal.

2. Inhalation exposure . The potential for inhalation exposure to Bacillus pumilus strain QST2808 pesticide residues for the general population, including infants and children is unlikely because potential use sites are agricultural and horticultural. However, since Bacillus pumilus is a natural occurring bacteria in soil, there is a great likelihood of prior exposure for most, if not all individuals. Accordingly, the increase in exposure due to this proposed product would be negligible. Furthermore, and as demonstrated in Unit III of this action, the acute pulmonary toxicity/pathogenicity testing performed on the technical formulation did not demonstrate pathogenicity or toxicity of Bacillus pumilus strain QST2808. (See Unit III above.) Accordingly, the risks anticipated for this route of exposure are considered minimal.

The Agency has considered the potential for cumulative effects of Bacillus pumilus strain QST2808 and other substances in relation to a common mechanism of toxicity. These considerations include the possible cumulative effects of such residues on infants and children. Bacillus pumilus strain QST2808 is practically non-toxic to mammals. Because no mechanism of pathogenicity or toxicity in mammals has been identified for this organism (see Unit III above), no cumulative effects from the residues of this product with other related microbial pesticides is anticipated.

There is a reasonable certainty that no harm to the U.S. population, including infants and children, will result from aggregate exposure to residues of Bacillus pumilus strain QST2808 due to its use as a microbial pest control agent. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. As discussed previously, Bacillus pumilus strain QST2808 is not pathogenic or infective and is practically non-toxic to mammals. (See Unit III above.) Accordingly, exempting Bacillus pumilus strain QST 2808 from the requirement of a tolerance should be considered safe and pose no significant risk.

FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of exposure (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 exposure (safety) will be safe for infants and children. Margins of exposure (safety) are incorporated into EPA risk assessments either directly through the use of a margin of exposure analysis or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. Due to the ubiquitous nature of Bacillus pumilus , residues of this microbial pesticide in or on agricultural commodities are not expected to significantly increase exposure to the U.S. population, including infants and children. Here, EPA concludes that the toxicity and exposure data are sufficiently complete to adequately address the potential for additional sensitivity of infants and children to residues of Bacillus pumilus strain QST2808 and that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to Bacillus pumilus strain QST2808 residues.

EPA is required under section 408(p) of the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) “may have an effect in humans that is similar to an effect produced by a naturally-occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there is no scientific basis for including, as part of the screening program, the androgen and thyroid hormone systems in addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation that the program include evaluations of potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency's EDSP have been developed, Bacillus pumilus strain QST2808 may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption.

To date, the Agency has no information to suggest that Bacillus pumilus strain QST2808 has an effect on the endocrine systems. Moreover, as is expected from a non-pathogenic microorganism that is practically non-toxic to mammals, the submitted toxicity/pathogenicity studies in rodents indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. (BPPD Review - 1/7/02).

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation for the reasons stated above, including Bacillus pumilus strain QST2808's lack of mammalian toxicity. For the same reasons, the Agency has concluded that an analytical method is not required for enforcement purpose for Bacillus pumilus strain QST2808.

There is no Codex Alimentarius Commission Maximum Residue Level for Bacillus pumilus strain QST2808.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP-2003-0113 in the subject line on the first page of your submission. All objections and requests for hearings must be in writing, and must be mailed or delivered to the Hearing Clerk on or before August 18, 2003.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.1. Mail your copies, identified by docket ID number OPP-2003-0113, 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 temporary exemption from the tolerance requirement for Bacillus pumilus strain QST2808 under section 408(d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, 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 ID number OPP-2003-0196. 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 March 26, 2003 (68 FR 14622) (FRL-7299-3), 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 2E6375, 2E6488, 2E6489, and 2E6495) by IR-4, 681 U.S. Highway #1 South, North Brunswick, NJ 08902-3390. That notice included a summary of the petitions prepared by Syngenta, the registrant.

The petitions requested that 40 CFR 180.507 be amended by establishing tolerances for combined residues of the fungicide azoxystrobin, methyl ( E )-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]- ∝ -(methoxymethylene) benzeneacetate and its Z isomer methyl (Z)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]- ∝ -(methoxymethylene) benzeneacetate, in or on artichoke, globe at 4.0 parts per million (ppm); asparagus at 0.02 ppm; brassica, head and stem, subgroup 5A at 3.0 ppm; herb subgroup 19A, dried, except chive at 260 ppm; and herb subgroup 19A, fresh, except chive at 50 ppm.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for tolerances for combined residues of azoxystrobin on artichoke, globe at 4.0 ppm; asparagus at 0.04 ppm; brassica, head and stem, subgroup 5A at 3.0 ppm; herb subgroup 19A, dried, except chive at 260 ppm; and herb subgroup 19A, fresh, except chive at 50 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 azoxystrobin are discussed in Unit III.A of the Final Rule on Azoxystrobin Pesticide Tolerance published in the Federal Register on September 20, 2002 (67 FR 59169)(FRL-7198-9).

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

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

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

The linear default risk methodology (Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases (e.g., risk is expressed as 1 x 10 -6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non-linear approach, a “point of departure” is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure (MOE cancer = point of departure/exposures) is calculated. A summary of the toxicological endpoints for azoxystrobin used for human risk assessment is discussed in Unit III.B. of the Final Rule on Azoxystrobin Pesticide Tolerance published in the Federal Register on September 20, 2002 (67 FR 59169)(FRL-7198-9).

1. Dietary exposure from food and feed uses . Tolerances have been established (40 CFR 180.507) for the combined residues of azoxystrobin, in or on a variety of raw agricultural commodities. Tolerances have been established for residues of azoxystrobin in or on a variety of raw agricultural commodities at levels ranging from 0.01 ppm (pecans) to 55 ppm (soybean hay), and on meat, fat, and meat byproducts of cattle, goats, hogs, horses, and sheep at levels ranging from 0.01 to 0.07 ppm, and on milk at 0.006 ppm. A time-limited tolerance (to expire on 12/31/2003) is currently established at 30 ppm for the head and stem Brassica vegetables, subgroup 5A. Risk assessments were conducted by EPA to assess dietary exposures from azoxystrobin in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. In conducting this acute 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 assumption was made for the acute exposure assessment: A Tier 1 acute dietary exposure analysis was performed for azoxystrobin.

ii. Chronic exposure . In conducting this chronic 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 chronic exposure assessments: The chronic dietary exposure analysis was performed for the general U.S. Population and all population subgroups using tolerance level residues (livestock) and total residues of concern (plants; parent and metabolites) and 100% crop treated data for the proposed commodities and all registered uses.

iii. Cancer . EPA's Cancer Assessment Review Committee (CARC) evaluated the carcinogenic potential of azoxystrobin and classified azoxystrobin as “not likely to be a human carcinogen” based on the revised Cancer Guidelines.

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

The Agency uses the 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 concentration in groundwater (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. FIRST and PRZM/EXAMS incorporate an index reservoir environment, and 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 azoxystrobin they are further discussed in the aggregate risk section in Unit III.E.

Although moderately persistent in soils and stable to hydrolysis, the likelihood of azoxystrobin moving into ground and surface water is low due to high soil/water partitioning coefficients and low single application rates. However, with multiple applications and repeated usage, azoxystrobin and especially its degradate (“compound 2”, ( E )-2-2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]-3-methoxyacrylic acid) may eventually build up in environmental compartments and move into drinking water resources.

Based on the Tier I modeling results using the FQPA Index Reservoir Screening Tool (FIRST) model, azoxystrobin EECs in surface water are not likely to exceed 170 parts per billion (ppb) for the acute (peak) concentration or 33 ppb for the chronic (365-day) concentration. These values represent upper-bound estimates of the concentrations that might be found in surface water which result from the use of azoxystrobin on turf.

The SCI-GROW screening model developed in the Agency estimates potential ground water concentrations under hydrologically vulnerable conditions. Based on the highest use rate (turf use, nine applications per year, 10-day interval, and 0.55 lb ai/A/application), the upper-bound concentration of azoxystrobin was estimated at 3.1 ppb. This value was used for both acute and chronic risk assessments. This value represents upper-bound estimates of the concentrations that might be found in ground water which result from the use of azoxystrobin on turf.

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

Azoxystrobin is currently registered for use on residential non-dietary sites (turf and ornamentals). The risk assessment was conducted using the following residential exposure assumptions: There is a potential for short-term dermal and inhalation exposures to homeowners who apply products containing azoxystrobin; however, EPA did not identify dermal endpoints for azoxystrobin. Because no dermal endpoints could be indentified, EPA expects no risk from dermal exposure to azoxystrobin. There is also potential for non-dietary, oral exposure following lawn treatment. Short- and intermediate-term non-dietary, oral exposure assessments were included for toddlers, since EPA selected toxicology endpoints for these exposures and there is a potential for hand-to-mouth and object-to mouth transfer of residues from treated turfgrass and incidential ingestion of soil from treated turfgrass.

Postapplication exposures from various activities following lawn treatment are considered to be the most common and significant in residential settings. The exposure via incidental ingestion of other plant material may occur but is considered negligible. The residential exposure and risk assessment was conducted using the application for turf because it is the highest single use rate. Azoxystrobin may be applied to turf at rates of up to 0.9516 active ingredient (a.i.) per acre five times per year (i.e., not to exceed 5 lb/ai/acre/year).

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

EPA does not have, at this time, available data to determine whether azoxystrobin 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 azoxystrobin and any other substances and azoxystrobin does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that azoxystrobin has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the 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 Web site 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 . Azoxystrobin studies have indicated no increased susceptibility of rats or rabbits to in utero and/or postnatal exposure to azoxystrobin.

3. Conclusion . There is a complete toxicity data base for azoxystrobin and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10-fold safety factor for increased susceptibility of infants and children be removed (i.e., reduced to 1X). The FQPA factor is removed because:

• The toxicology data base is complete

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

• Unrefined chronic dietary exposure estimates (assuming all commodities contain tolerance level residues) will overestimate dietary exposure

• Modeling data are used for ground and surface source drinking water exposure assessments resulting in estimates considered to be upper-bound concentrations

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to azoxystrobin will occupy 10% of the aPAD for the U.S. population, 17% of the aPAD for children 1-2 years old, 9% of the aPAD for females 13 years and older, and 10% of the aPAD for adults 50+ years old. In addition, there is potential for acute dietary exposure to azoxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 1 of this unit:

2. Chronic risk . Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to azoxystrobin from food will utilize 12% of the cPAD for the U.S. population, 22% of the cPAD for children 1-2 years old, 11% of the cPAD for females 13-49 years old, and 11% for adults 50+ years old. Based on the use pattern, chronic residential exposure to residues of azoxystrobin is not expected. In addition, there is potential for chronic dietary exposure to azoxystrobin in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in the following Table 2:

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

Azoxystrobin is currently registered for use that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short-term exposures for azoxystrobin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 1,200 for adults, and 430 for children 1-2 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short-term DWLOCs were calculated and compared to the EECs for chronic exposure of azoxystrobin in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 3:

4. Intermediate-term risk . Intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Azoxystrobin is currently registered for use(s) that could result in intermediate-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and intermediate-term exposures for azoxystrobin.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 420 for children 1-2 years old. These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, intermediate-term DWLOCs were calculated and compared to the EECs for chronic exposure of azoxystrobin in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect intermediate-term aggregate exposure to exceed the Agency's level of concern, as shown in the following Table 4:

5. Aggregate cancer risk for U.S. population . There is no evidence for mutagenicity or carcinogenicity. Azoxystrobin has been classified as “not likely to be carcinogenic in humans” by EPA; therefore, azoxystrobin is not expected to pose a carcinogenic 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 azoxystrobin residues.

Adequate methodology is available for enforcement of these tolerances. The gas chromatography/nitrogen phosphorous detector (GC/NPD) method (RAM 243/04) has undergone a method validation by the EPA analytical laboratory. EPA comments have been incorporated and the revised method (designated RAM 243) will be submitted to FDA for inclusion in PAM, Volume II as an enforcement method.

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 .

No Codex, Canadian, or Mexican Maximum Residue Levels (MRLs) have been established for residues of azoxystrobin. Therefore, no tolerance discrepancies exist between countries for this chemical.

Therefore, the tolerances are established for combined residues of azoxystrobin, methyl ( E )-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]- ∝ -(methoxymethylene)-benzeneacetate, and its Z isomer, methyl (Z)-2-[[6-(2-cyanophenoxy)-4-pyrimidinyl]oxy]- ∝ -(methoxymethylene)-benzeneacetate, in or on artichoke, globe at 4.0 ppm; asparagus at 0.04 ppm; brassica, head and stem, subgroup 5A at 3.0 ppm; herb subgroup 19A, dried, except chive at 260 ppm; and herb subgroup 19A, fresh, except chive at 50 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-2003-0196 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 August 18, 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-2003-0196, 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).

Entities potentially covered by this regulation are public or private individuals or groups that generate residential lead-based paint (LBP) waste as a result of abatement, rehabilitation, renovation and remodeling in homes, residences, and other households. By “households,” we mean single and multiple residences, hotels and motels, bunkhouses, ranger stations, crew quarters, campgrounds, picnic grounds, and day-use recreation areas. Affected categories and entities include:

The table above is not intended to be exhaustive but, rather, is intended to provide examples of entities likely to be regulated by this action. To determine whether your facility would be impacted by this action, you should carefully examine the applicability criteria in this rule. If you have questions regarding the applicability of this action to a particular facility, please contact Paul Cassidy, U.S. EPA, Office of Solid Waste (5306W), 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone 703-308-7281; e-mail: cassidy.paul@epa.gov .

1. Docket. EPA has established an official public docket for this action under Docket ID No. RCRA-2001-0017. The official public docket consists of the documents specifically referenced in this action, any public comments received and other information related to this action. The official public docket is the collection of materials that is available for public viewing at the RCRA Information Center (RIC), located at EPA West, Room B-102, 1301 Constitution Ave. NW., Washington DC. The Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744. In the Washington, DC, metropolitan area, call 202-566-0270 or TDD 703-412-3323 (hearing impaired). To review the docket materials in person, we recommend that the public make an appointment by calling 202-566-0270. The public can copy a maximum of 100 pages from the docket at no charge. Additional copies cost $0.15/page. If you access the information electronically, you can download or print copies free of charge.

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 .

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 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 identification number. 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 above in Unit I.B.

EPA is promulgating this rule pursuant to section 1008(a)(3), 2002(a), 4004(a) and 4010(c) of the Resource Conservation and Recovery Act (RCRA), 42 U.S.C. Secs. 6907(a), 6912(a), 6944(a), 6949a(c). We are also correcting a typographical error in the existing statement of authority in part 257 by amending the citation to 42 U.S.C. 6949(c) to read “6949a(c).”

In its October 23, 2001, proposal (see 66 FR 53566-53573) regarding the disposal of residential lead-based paint waste, the Agency proposed to expressly allow construction and demolition landfills to receive residential lead-based paint (LBP) waste. 1 This was to be accomplished in part by adding a sentence to the definition of municipal solid waste landfill (MSWLF) unit in 40 CFR 257.2 and 258.2, as follows: “A construction and demolition landfill that receives residential lead-based paint waste and does not receive any other household waste is not a MSWLF unit.” The Agency explained in the preamble to the proposal that the existing definition of a MSWLF unit includes language which states that a disposal unit “that receives household waste” is a municipal solid waste landfill unit. This language can be construed to prohibit the disposal of any household waste into a facility that is not designed and operated in conformance with 40 CFR part 258 regulations. As a result the Agency proposed to amend the definition of MSWLF unit, to distinguish residential lead-based paint waste, which has been determined to be a household waste, from other types of household waste, for purposes of disposal.

The definition as proposed is as follows: “Municipal solid waste landfill (MSWLF) unit means a discrete area of land or an excavation that receives household waste, and that is not a land application unit, surface impoundment, injection well, or waste pile, as those terms are defined in this section. A MSWLF unit also may continue to receive other types of RCRA Subtitle D wastes, such as commercial solid waste, nonhazardous sludge, and industrial solid waste. Such a landfill may be publicly or privately-owned. A MSWLF unit may be a new MSWLF unit, an existing MSWLF unit or a lateral expansion. A construction and demolition landfill that receives residential lead-based paint waste and does not receive any other household waste is not a MSWLF unit.”

The proposed change was designed to simply distinguish residential LBP waste from other household wastes. The proposal would not alter what a MSWLF could or could not receive. MSWLFs would be allowed to continue to receive residential LBP waste as household waste. The proposed rule expressly provided an additional land-based waste disposal option for residential LBP waste.

The October 23, 2001 notice also proposed to add a definition of a construction and demolition (C&D) waste landfill, which would expressly allow only C&D landfills, and no other types of land disposal units that meet the criteria of 40 CFR part 257, to receive residential LBP waste. The Agency proposed to define a C&D landfill as follows: “Construction and demolition (C&D) landfill means a solid waste disposal facility subject to the requirements of subparts A or B of this part that receives construction and demolition waste and does not receive hazardous waste (defined in Sec. 261.3 of this chapter) other than conditionally exempt small quantity generator waste (defined in Sec. 261.5 of this chapter), or industrial solid waste (defined in Sec. 258.2 of this chapter). A C&D landfill typically receives any one or more of the following types of solid wastes: roadwork material, excavated material, demolition waste, construction/renovation waste, and site clearance waste.” The proposed rule would add this definition to 40 CFR parts 257 and 258.

Finally, EPA proposed to define “residential lead-based paint waste” to clarify the scope of the waste stream addressed by the proposed rule. The proposed definition of residential lead-based paint waste is as follows: “Residential lead-based paint waste means waste generated as a result of lead-based paint activities (including abatement, rehabilitation, renovation and remodeling) in homes and other residences. The term residential lead-based paint waste includes, but is not limited to, lead-based paint debris, chips, dust, and sludges.” Not included in the proposed definition of residential LBP waste were residential LBP demolition and deconstruction waste, and LBP waste from nonresidential structures such as public and commercial buildings, warehouses, bridges, water towers, and transmission towers.

In proposing the definition of residential lead-based paint waste, the Agency included these particular LBP activities because they were limited to residences and would pose lead hazards to occupants, especially to children. We included the particular waste types ( i.e. , debris, chips, dust, and sludges) because they are typically generated during the named LBP activities.

In the preamble to the proposal, EPA explained the Agency's rationale and justification of the proposed changes, as well as the analytical basis for the proposal. The proposal provided a specific discussion of: (1) The reasons that residential lead-based paint is a concern to children; (2) the Congressional enactment of the Residential Lead-Based Paint Hazard Reduction Act of 1992 (hereinafter referred to as Title X of the Housing and Community Development Act of 1992, or Title X); (3) the concerns of stakeholders who have seen the application of RCRA's hazardous waste regulations as a barrier to the cost-effective abatement of lead hazards; (4) the 1988 proposed rule under the Toxic Substances Control Act (TSCA) which proposed new TSCA management and disposal standards for LBP debris generated by contractors from pre-1978 homes and public and commercial buildings; (5) the 1988 temporary suspension of the toxicity characteristic for specified lead-based paint debris under RCRA; and (6) the July 31, 2000 memorandum clarifying the regulatory status under RCRA Subtitle C of wastes generated as a result of LBP activities, including abatements, renovation and remodeling, and rehabilitations in homes and other residences. In the July 31, 2000 memorandum, the Agency interpreted residential LBP waste as a household waste excluded from the hazardous waste management requirements pursuant to the household waste exclusion in 40 CFR 261.4(b)(1), thus giving rise to the proposed amendments to parts 257 and 258 to expand disposal options for residential LBP waste to include C&D landfills, as well as MSWLF units.

The Agency received a total of eight comments on the proposed residential LBP waste rule: four from construction and/or demolition trade associations, and one each from a state, an association of state agencies, an environmental organization, and an individual. In general, commenters supported the proposal to allow residential LBP waste to be disposed of in C&D landfills. However, some commenters requested clarifications of the rule or preamble language or suggested additions to the rule language.

The state commenter argued that the proposed rule contained a significant flaw by including chips, dust and sludges in the definition of “residential lead-based paint waste,” because EPA failed to take into account the potential for sleet, surface-water or wind-borne movement of lead paint chips, dust, and sludges off-site from a C&D landfill. The commenter stated that the placement of LBP dust, chips and sludges in an open environment ( i.e. , a landfill that does not provide for daily cover) over an extended period of time, e.g. , 30 days, may allow a significant rain or wind event to transport lead-containing materials off-site. The commenter further stated that sudden intense rain events or winds above 20 to 25 miles per hour can transport lead-containing wastes off-site by surface water or air currents. The commenter suggested that requiring daily cover or special packaging at C&D landfills for the above-mentioned wastes would mitigate the potential for adverse impact from surface water or air transport.

Because other features of C&D landfills and LBP waste handling practices serve to mitigate potential impacts from surface water or air transport, the Agency does not believe that requirements for daily cover or special packaging are needed on the federal level. Surface water transport off-site by sudden intense rain events would constitute “non-point source” pollution under the Clean Water Act. To mitigate potential surface water impacts, C&D landfills must comply with 40 CFR 257.3-3(c), which requires that a facility or practice shall not cause non-point source pollution that violates legal requirements implementing an areawide or statewide water quality management plan approved by EPA under the Clean Water Act.

To further mitigate potential water or air transport, both EPA and the U.S. Department of Housing and Urban Development (HUD) have issued guidance for LBP waste management calling for the containment of LBP wastes in plastic with sealed seams. EPA's “Reducing Lead Hazards When Remodeling Your Home” EPA 747-K-97-001 (http://www.epa.gov/lead/rrpamph.pdf) and EPA's Model Renovation Training Course EPA 747-B-00-005/6 ( http://www.epa.gov/opptintr/lead/rrmodel.htm ) both call for safe and secure disposal. Safe and secure disposal involves placing the LBP wastes in plastic (4-6 mil poly) bags that are sealed closed. HUD modified the EPA training course and developed their own training program to serve the specific needs of HUD's constituents. The HUD training course entitled “Addressing Lead-Based Paint Hazards During Renovation, Remodeling and Rehabilitation in Federally Owned and Assisted Housing” (also referred to as “The 3R Course”) (http://www.hud.gov/offices/lead/training/3r/3r_course.cfm) was first delivered to remodeling and rehabilitation workers during HUD's nationwide training initiative in 2001-2002. HUD's training recommends that safe disposal of LBP wastes be accomplished by means of plastic bags. Other HUD brochures and documents also recommend that LBP wastes be placed in plastic bags for safe disposal. These brochures include:

HUD also operates the Lead-Based Paint Hazard Control Grant Program that has as its primary purpose to reduce the exposure of young children to lead-based paint hazards in their homes. The program provides grants to State and local governments for control of lead-based paint hazards in privately owned, low income owner-occupied and rental housing. These grants are designed to stimulate the development of a trained and certified hazard evaluation and control industry. Evaluation and hazard control work under the program must be conducted by either contractors who are certified and workers who are trained through a State-accredited program or by contractors trained in lead-safe work practices in the case of interim controls.

Moreover, as of March 1, 2000, lead service providers within the United States must be certified (or licensed) under an EPA authorized lead program. Most of the States have developed and are administering such a program and EPA certifies lead service providers in states that do not have their own programs. As of January 2003, 38 States had EPA-approved state lead programs that actively certify (license) lead service providers.

EPA has also discussed this issue with the National Association of Demolition Contractors (NADC). NADC re-confirmed EPA's understanding that paint chips and dust are managed in plastic bags. NADC stated that lead-based dust is removed with vacuums with HEPA filters and that the vacuum bags are removed and then tied closed prior to disposal. Paint chips that may fall on a plastic sheet are collected in the plastic sheet which is then placed in a tied plastic bag.

As stated above, the EPA believes that sufficient guidance, literature, training programs, EPA-approved state lead programs, and current practices exist so that whether the LBP waste is in the form of chips, dust, or sludge it will be managed appropriately ( i.e. , containment in plastic bags on site prior to transport to disposal). At the disposal facility, the containment plastic serves to mitigate against potential impacts of water or wind transport.

Additionally, where water or wind transport are problematic, States have demonstrated their ability, even in the absence of a federal requirement, to impose additional requirements for weekly, monthly, or daily cover as necessary to control particulate releases. According to the 1995 report, “Construction and Demolition Waste Landfills,” 14 States require on-site C&D units to provide daily cover, while 19 States require daily cover at off-site C&D units. Based on these C&D landfill features and LBP waste handling practices, the Agency does not believe it is necessary to impose on the federal level a requirement for daily cover at C&D landfills receiving LBP waste.

Two industry association commenters stated that lead-based paint architectural debris generated from all structures, commercial and industrial, as well as, residential, can safely be disposed of in C&D landfills ( i.e. , Subtitle D facilities). The commenters disagreed with the Agency's statement in the preamble that demolition and deconstruction waste was not similar to household waste. The commenters believe that LBP material handled by the demolition industry in commercial and industrial structures is no more dangerous to public health and the environment than when LBP appears in a residential structure.

The Agency wishes to clarify that today's rule is an outgrowth of the July 31, 2000 Memorandum stating that waste generated as a result of LBP activities in homes and other residences falls within the exclusion for “household waste” in 40 CFR 261.4(b)(1). (See 66 FR 53569.) The scope of this rulemaking concerns only residential lead-based paint wastes and not lead-based paint wastes from commercial and industrial structures because lead-based paint waste from commercial and industrial structures does not fall within the exclusion for “household waste” in 40 CFR 261.4(b)(1) or the definition of “household waste” in 40 CFR 258.2. Thus, residential LBP waste that would otherwise be hazardous waste subject to the hazardous waste management requirements of Subtitle C of RCRA can be managed under Subtitle D of RCRA. The purpose of this rulemaking is to expand Subtitle D disposal options for this particular household waste, which, without today's rule could only be disposed of in municipal solid waste landfills pursuant to 40 CFR part 258.

The July 31, 2000 Memorandum did not affect the regulatory status of nonresidential LBP waste, such as that generated during the abatement or renovation and remodeling of a commercial building. “Household waste” is defined as “any material (including garbage, trash and sanitary waste in septic tanks) derived from households (including single and multiple residences, hotels and motels, bunkhouses, ranger stations, crew quarters, campgrounds, picnic grounds and day-use recreation areas).” (Emphasis added.)

The Agency recognizes that not all lead-based paint waste, whether from residential, commercial, or industrial sources, is “hazardous waste” which must be managed under RCRA Subtitle C. Any LBP waste that is not hazardous waste can be safely disposed of in a Subtitle D landfill, including a C&D waste landfill.

Several commenters stated that the proposed rule was not sufficiently clear as to the distinctions between those LBP activities that generate waste that would qualify as “residential LBP waste” ( e.g. abatement, rehabilitation, renovation, and remodeling”) and those that would not fall within the scope of the rule ( e.g. , “demolition and deconstruction”). One of these commenters stated that the regulated community might believe that there is some deconstruction or demolition occurring whenever you perform rehabilitation, renovation, remodeling, and perhaps to some extent abatement. The commenter suggested that the focus of the final rule be on waste type and not on waste activity.

The Agency distinguishes demolition and deconstruction activities from abatement, rehabilitation, renovation, and remodeling on the basis that demolition and deconstruction result in the elimination of the residential structure, while the residential structure remains where the other listed activities are conducted. The proposed definition of residential lead based paint waste does not include residential demolition and deconstruction activities. The proposed definition was limited to LBP waste that would be subject to Subtitle C of RCRA, except that it is included within the household waste exclusion in 40 CFR 261.4(b)(1). The Agency has applied two criteria to define the scope of the exclusion: (1) The waste must be generated by individuals on the premises of a household, and (2) the waste must be composed primarily of materials found in the wastes generated by consumers in their homes (49 FR 44978 and 63 FR 70241). In the case of LBP wastes, we have determined that demolition and deconstruction, which result in the elimination of the household structure, are outside the scope of the household waste exclusion and therefore are not included in the definition of “residential LBP waste.” Although demolition activities and renovation activities may produce some of the same types of waste, the waste type is not a factor for consideration under 40 CFR 261.4(b)(1), and therefore, today's final rule continues to read as proposed. The Agency wants to make it clear that deconstruction and demolition wastes can continue to be placed in construction and demolition waste landfills provided that these types of wastes do not exhibit the toxicity or any other characteristic ( i.e. , are not a hazardous waste).

One commenter was specifically concerned that the proposed definition of residential lead-based paint waste could create confusion about the scope of activities that are considered “lead-based paint activities” under the Toxic Substances Control Act (TSCA). The proposed residential LBP definition states that LBP activities include abatement, rehabilitation, renovation, and remodeling. Regulations promulgated under TSCA define “lead-based paint activities” to mean lead inspection, risk assessment, and abatement in the case of target (most pre-1978) housing (see 40 CFR 745.223). Renovation, remodeling, and rehabilitation are not considered lead-based paint activities under Title X. The commenter was concerned that the Agency was trying to change the scope of the TSCA regulation under the proposed RCRA regulation. The commenter suggested that the term lead-based paint activities be deleted and replaced with the phrase “activities that disturb lead-based paint.”

The Agency did not intend or propose to change the scope of the TSCA regulation in the October 2001 proposal. However, to eliminate any potential confusion, the Agency has decided to change the definition of residential LBP wastes to eliminate the words “lead-based paint activities.” The definition of residential LBP wastes included in today's final rule does not use the term “lead-based paint activities.” This definition is as follows: “Residential lead-based paint waste means waste containing lead-based paint, which is generated as a result of activities such as abatement, rehabilitation, renovation and remodeling in homes and other residences. The term residential lead-based paint waste includes, but is not limited to, lead-based paint debris, chips, dust, and sludges.”

A trade association commenter objected to the proposed definition of “construction and demolition waste landfill” because the proposed rule would define a C&D waste landfill as one that does not receive “industrial wastes,” as defined in section 258.2. The commenter objected because the definition as proposed would preclude a C&D landfill that receives industrial waste in the form of manufacturer's “off-spec,” rejected, or damaged construction materials from accepting residential lead-based paint waste. Thus C&D landfills in that state would have to choose between residential LBP waste or off spec., damaged, or rejected construction materials, but not both.

In the proposed definition of construction and demolition waste landfill, the Agency stated that C&D waste landfills were not eligible to receive “industrial solid wastes as defined in 40 CFR 258.2.” The definition of “industrial solid waste” in section 258.2 covers “wastes resulting from” particular manufacturing or industrial processes. In defining C&D landfills, the Agency was concerned about C&D waste landfills receiving wastes generated by manufacturing or industrial processes and, as such, wrote the definition to exclude such wastes. In practice, industrial process wastes are typically managed on-site, or in limited cases, sent off-site to private/commercial industrial waste facilities. Industrial process wastes should not be received for disposal at a C&D waste landfill. The commenter was concerned that off-spec construction products ( e.g. , toilets or shingles) would not be allowed in a C&D waste landfill because of the proposed definition. However, the Agency views “off-spec,” rejected, or damaged construction materials as virtually identical in nature to the type of waste that is appropriately received at a C&D waste landfill and are not “industrial solid waste” as defined at 40 CFR 258.2. Because the definition of industrial solid waste does not explicitly include materials that do not meet manufactures' specifications, are damaged or rejected for use, EPA believes that industrial waste in the form of manufacturer's “off-spec,” rejected, or damaged construction materials can be appropriately placed in a C&D landfill. In addition, the Agency expects that States would exercise judgment in what is considered industrial wastes. Thus, EPA believes that the definition in today's final rule accommodates disposal of unused construction materials that do not meet manufacturers' specifications, are damaged or rejected for use.

Another commenter stated that the definition of C&D landfill as proposed could be interpreted to mean that conditionally exempt small quantity generator waste could be accepted in a 40 CFR part 257 Subpart A facility. The commenter suggested a wording change to eliminate this possible misinterpretation.

EPA does not intend that a C&D landfill be allowed to receive conditionally exempt small quantity generator wastes if the C&D landfill meets the requirements of 40 CFR part 257 Subpart A, but does not meet the requirements of part 257, subpart B. Therefore, the Agency has changed the definition of C&D waste landfill to eliminate any potential confusion. The definition has been changed to clarify that conditionally exempt small quantity generator wastes can only be disposed of in a C&D landfill that meets the requirements of 40 CFR part 257, Subpart B.

The state association commenter indicated that it is important that EPA be explicit that states are not required to amend their programs to incorporate today's rule; however the commenter also suggested language to assure States that their prior approved programs will not be reopened regardless of whether they adopt today's rule or not. EPA agrees with the comment and has revised the language in Section V. of today's preamble to make this clear.

Lastly, a commenter stated that EPA had missed a golden opportunity to allow lead-contaminated soils to be managed similarly and requested that EPA move expeditiously to craft a rule to allow lead-contaminated soils to be disposed of in C&D and municipal solid waste landfills. The commenter claimed that the disposal of lead-contaminated soils in C&D landfills and municipal solid waste landfills is environmentally safer than is the disposal of lead-based paint debris. The commenter also argued that the cost of managing those soils that fail the TCLP under the RCRA hazardous waste requirements discourages soil lead abatement from residences. As discussed previously, today's rulemaking is limited to providing the C&D landfill disposal option for residential lead-based paint waste addressed in the July 31, 2000 Memorandum. Lead-contaminated soils were not included in the July 31, 2000 Memorandum, thus EPA is not addressing disposal of lead-contaminated soils at this time.

This final rule will expressly allow residential lead-based paint waste to be disposed of in construction and demolition waste landfills by clearly stating that a construction and demolition landfill accepting residential lead-based paint waste, and no other household waste, is not a municipal solid waste landfill unit. Today's action does not prevent a municipal solid waste landfill from continuing to receive residential lead-based paint waste. Two minor changes were made to the final regulatory language based on comments received on the proposal. Today's final rule was modified to remove “LBP activities” to one that includes “activities that disturb LBP.” The definition of construction and demolition waste landfill was changed to eliminate any confusion so that small quantity generator waste can only be disposed of in a facility that meets the requirements of 40 CFR part 257, subpart B.

Today's final rule would not alter the authority of State, local and Tribal governments to regulate LBP waste more stringently than does EPA. Generators of residential LBP waste should contact the appropriate State environmental agencies to determine if there are additional or more stringent disposal requirements for residential LBP waste. Also, generators are subject to applicable HUD and/or TSCA regulations when addressing residential LBP hazards.

Because today's final rule is less stringent than existing federal criteria, States are not required to amend their permit programs which have been determined to be adequate under 40 CFR part 239. States have the option of amending statutory or regulatory definitions pursuant to today's final rule. If a state chooses to amend its permit program pursuant to today's action, the State would be required to notify the Regional Administrator of the modification as provided by 40 CFR 239.12. Whether a State chooses to incorporate today's rule into its solid waste program has Statutory and Executive Order Reviews no effect on its existing status with respect to EPA approval, i.e. , State revisions will not open previously approved solid waste programs for Federal review.

Today's amendments are directly applicable to landfills in States without an approved permit program under part 239 and in Indian Country. We encourage Tribes to adopt today's rule into their programs to promote lead-based paint abatement activities in homes and other residences in Indian Country.

Under Executive Order 12866, EPA must determine whether a regulatory action is significant and therefore subject to Office of Management and Budget (OMB) review and the other provisions of the Executive Order. The Order defines a significant regulatory action as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or rights and obligations or recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866.

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

EPA has performed a full economic analysis, “Economic Analysis of EPA's Final Rule Amending 40 CFR parts 257 and 258,” which is available in the docket for today's rule. The Economic Analysis concludes that this rule will impose no additional costs to parties, but may result in cost savings and incremental public health benefits. The rule authorizes the disposal of residential LBP waste in C&D landfills, where previously, as “household waste” under the July 31, 2000 policy memorandum, disposal was authorized only in MSWLFs. Therefore, EPA believes that, in those parts of the country where costs associated with transport to and disposal in C&D landfills is less expensive than costs associated with MSWLF disposal, some residential LBP waste will be diverted from MSWLFs to C&D landfills. Where this occurs, generators will benefit from lower waste management and disposal costs.

EPA believes that only residential LBP waste generators in the Midwest, Northeast, and South regions will shift disposal from MSWLFs to C&D landfills, based on an analysis of the relative costs of MSWLF and C&D landfill disposal by region. EPA further believes that the percentage of residential LBP waste that is affected is proportional to the share of these three regions in the number of housing units with LBP, which is 84.4 percent. Under these assumptions, an estimated 0.87 million tons of residential LBP waste may be diverted from MSWLFs to C&D landfills annually. This represents 0.73 percent of the total volume of all waste disposed of in MSWLFs annually. This shift in disposal would save residential LBP waste generators in the Midwest, Northeast, and South regions up to an estimated $16.76 million annually. The savings accruing to generators of residential LBP abatement waste is estimated at $0.79 million per year, while the savings accruing to generators of residential renovation and remodeling waste is $15.98 million per year.

EPA estimates that of the $0.79 million in savings that could accrue to generators of residential LBP abatement waste, an estimated 39.7 percent, or $0.31 million, will be generated annually in the public housing sector. EPA assumes that in the public sector, any savings in residential LBP waste management and disposal costs will be used to conduct additional LBP abatements. Given an average cost for LBP abatement in public housing units of $3,650, the $0.31 million in annual savings would fund an additional 86 abatements each year. This ensuing increase in LBP abatement projects would result in a more rapid reduction in the potential for exposure to the hazards of LBP, especially for children. These hazards include decreased intelligence ( i.e. , lower IQ), behavioral problems, reduced physical stature and growth, and impaired hearing.

The Office of Management and Budget (OMB) has approved the information collection requirements contained in this rule under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2050-0154. Copies of the ICR document(s) may be obtained from Susan Auby, by mail at the Office of Environmental Information, Collection Strategies Division, U.S. Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW., Washington, DC 20460, by email at auby.susan@epa.gov, or by calling (202) 260-2740. A copy may also be downloaded off the Internet at http://www.epa.gov/icr.

Today's action does not impose any new information collection burden. The previously approved information collection requirements are contained in the existing regulations at 40 CFR 257.30. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An Agency may not conduct or sponsor, and a person is not required to respond to a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR Chapter 15.

The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. , generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's final rule on small entities, a small entity is defined as: (1) A small business that is primarily engaged in lead paint removal as described in the North American Industry Classification System (see http://www.sba.gov/size/SIC2NAICSmain.html); (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule does not impose any new requirements on small entities. In fact, the rule will provide an additional non-mandatory option for the disposal of residential LBP waste, which could result in less cost in managing residential LBP waste.

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

Today's final rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector. This final rule does not impose any enforceable duty on any State, local or tribal governments or the private sector. Thus, today's final rule is not subject to the requirements of sections 202 and 205 of UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), 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 does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. As explained in Section V. of this preamble, none of today's proposed revisions are more stringent or broaden the scope of the existing Federal requirements. Therefore, States are not required to adopt the revision to the definition of MSWLF unit nor the additional definitions of construction and demolition (C&D) landfill and residential lead-based paint waste in today's rule. Thus, Executive Order 13132 does not apply to this final rule.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This final rule does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Today's final rule would expressly provide an additional option for disposal of certain waste applicable in Indian Country, but would not create any mandate on Indian tribal governments. Thus, Executive Order 13175 does not apply to this rule.

Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

This final rule is not subject to Executive Order 13045 because it is not an economically significant rule as defined by Executive Order 12866. However, this rule will affect decisions involving the environmental health or safety risks to children. In fact, it will benefit children by allowing environmentally protective disposal of residential lead-based paint waste in C&D landfills, which is less costly than disposal in MSWLFs in certain areas of the U.S., therefore reducing the cost of lead abatements. Reducing the cost of LBP abatements will also reduce the amount of time needed to complete abatements in public housing. Lower abatement costs may increase the amount of private homes undergoing abatements. By reducing costs associated with the disposal of LBP waste, the Agency believes that the number of abatements may marginally increase, thus resulting in a reduction of the number of children exposed to LBP.

This proposed rule is not a “significant energy action” as defined in Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)) because it will not have a significant adverse effect on the supply, distribution, or use of energy.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Pub L. 104-113, Sec. 12(d) (15 U.S.C. 272 note) directs us to use voluntary consensus standards in our regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (for example, materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when we decide not to use available and applicable voluntary consensus standards. Today's final rule does not involve technical standards, voluntary or otherwise. Therefore, the NTTAA does not apply to today's final rule.

Under Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations,” as well as through EPA's April 1995, “Environmental Justice Strategy, OSWER Environmental Justice Task Force Action Agenda Report,” and the National Environmental Justice Advisory Council, EPA has undertaken to incorporate environmental justice into its policies and programs. EPA is committed to addressing environmental justice concerns, and is assuming a leadership role in environmental justice initiatives to enhance environmental quality for all residents of the United States. The Agency's goals are to ensure that no segment of the population, regardless of race, color, national origin, or income, bears disproportionately high and adverse human health and environmental effects as a result of EPA's policies, programs, and activities.

Today's final rule is not expected to negatively impact any community, and therefore is not expected to cause any disproportionately high and adverse impacts to minority or low-income communities versus non-minority or affluent communities. On the contrary, since the rule will reduce the cost of performing LBP abatements in certain regions of the U.S., EPA believes that the savings will afford public housing authorities, in particular, the opportunity to conduct additional abatements of LBP hazards in affected housing units. Tenants of public housing units are possibly more likely to be minority and lower-income households, and the rule should have the effect of providing a differential benefit to such populations.

The Congressional review Act, 5 U.S.C. 801 et seq. , as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that, before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C., 804(2). This rule will be effective on June 18, 2003.

This rule revises the Secretary's reservation of authority under the Deepwater Port Act, as amended. The Secretary is delegating to the Maritime Administrator his authority to issue, transfer, amend, or reinstate a license for the construction and operation of a deepwater oil or natural gas port as provided for in the Deepwater Port Act of 1974, as amended, 33 U.S.C. 1501-1524 (DWPA). The DWPA, as amended by section 106 of the Maritime Transportation Security Act of 2002, Pub. L. 107-295, 116 STAT. 2064 at 286 (MTSA), governs the licensing of any offshore facility used to handle and transport petroleum and natural gas, pursuant to the amendment of the DWPA. A deepwater port must be licensed by the Secretary. To date, LOOP LLC is the only offshore deepwater port facility licensed by the Secretary under the DWPA. LOOP LLC's License was issued on January 17, 1977, and was amended and updated on June 1, 2000.

The Commandant of the United States Coast Guard (USCG) and the Administrator of the Maritime Administration (MARAD) have operated under delegated authority to coordinate the processing of applications for the issuance, transfer, amendment, or reinstatement of a license for the construction and operation of a deepwater port. 62 FR 11382 (March 12, 1997); 49 CFR 1.46(s) and 1.66(aa). The USCG has the additional statutory responsibility to approve an operations manual for a deepwater port. 33 U.S.C. 1503(e)(1). The USCG retained the statutory and delegated authorities upon its transfer to the Department of Homeland Security (Department of Homeland Security Delegation Number: 0170, § 2. (75), March 3, 2003; Pub. L. 107-296, section 888.). This rule does not change the authorities delegated to USCG and to MARAD nor does it change the coordination between the USCG and MARAD for processing license applications. The rule clarifies that the authorities of USCG and MARAD for processing license applications include the authorities to process an application for a license reinstatement. 33 U.S.C. 1503(b) and (f) (as amended by Pub. L. 98-419, Sept. 25, 1984).

This rule does not change the Secretary's previous delegation of DWPA authority to the Administrator of the Research and Special Programs Administration (RSPA) in 49 CFR 1.53(a)(3) for the establishment, enforcement, and review of regulations concerning the safe construction, operation or maintenance of pipelines on Federal lands and the Outer Continental Shelf (33 U.S.C. 1520).

By Federal Register notices dated, respectively, December 27, 2002 (67 FR 79234), and January 23, 2003 (68 FR 3299), the Department of Transportation through the USCG and MARAD gave notice, as required by the DWPA, of applications filed by Port Pelican LLC and El Paso Energy Bridge Gulf of Mexico, LLC for licenses to own, construct, and operate deepwater natural gas port facilities. Since then, MARAD and the USCG have been coordinating the processing of these applications. By this rule, MARAD has the authority over the issuance of the licenses for the respective applicants and for any future applicants.

This amendment to 49 CFR part 1 to reflect the Secretary's delegation of his authority to issue, transfer, amend or reinstate a license for the construction and operation of a deepwater port to the Maritime Administrator relates solely to departmental organization, procedure, and practice. Therefore, notice and comment are unnecessary under 5 U.S.C. 553(b). Further, since the amendment expedites the MARAD's ability to meet the statutory intent of the applicable laws and regulations covered by this delegation, the Secretary finds good cause under 5 U.S.C. 553(d)(3) for the final rule to be effective on the date of publication in the Federal Register .

This rulemaking is a nonsignificant regulatory action under section 3(f) of Executive Order 12866 and has not been reviewed by the Office of Management and Budget under that Order. This rule is also not significant under the regulatory policies and procedures of the Department of Transportation, 44 FR 11034.

This rule does not impose unfunded mandates or requirements that will have any impact on the quality of the human environment.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601 et seq. , (Act) was enacted by Congress to ensure that small entities are not unnecessarily and disproportionately burdened by government regulations. The Act requires agencies to review proposed regulations that may have a significant economic impact on a substantial number of small entities. For purposes of this rule, small entities include all small businesses that are potential offerors and contractors bidding on Department of Transportation proposed acquisitions. The Act does not apply to this rulemaking, since a notice of proposed rulemaking was not required. However, the Department certifies that this rule does not have a significant economic impact on a substantial number of small entities. The rule makes administrative changes to 49 CFR Part 1; therefore, a Regulatory Flexibility Analysis has not been performed.

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

This proposed rule has been reviewed in accordance with the principles and criteria contained in Executive Order 13132 dated August 4, 1999, and it is determined that this action does not have a substantial direct effect on the States, or the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. This rule will not limit the policymaking discretion of the State nor preempt any State law or regulation.