This final rule has been determined to be non-significant for purposes of Executive Order 12866 and therefore was not reviewed by the Office of Management and Budget.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. L. 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, the Food and Nutrition Service generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local or tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. When such a statement is needed for a rule, Section 205 of the UMRA generally requires the Food and Nutrition Service to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, more cost-effective or least burdensome alternative that achieves the objectives of the rule.

This final rule contains no Federal mandates (under the regulatory provisions of Title II of UMRA) for State, local and tribal governments or the private sector of $100 million or more in any one year. Thus, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

The Food Stamp Program is listed in the Catalog of Federal Domestic Assistance under No. 10.551. For the reasons set forth in the final rule in 7 CFR part 3015, subpart V and related Notice (48 FR 29115), this Program is excluded from the scope of Executive Order 12372 which requires intergovernmental consultation with State and local officials.

This rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act of 1980 (5 U.S.C. 601-612). Samuel Chambers, Jr., Administrator, Food and Nutrition Service, has certified that this final rule will not have a significant economic impact on a substantial number of small entities. Food stamp authorized retailers will be affected minimally. State and local welfare agencies will be the most affected to the extent that they administer the Program.

This rule does not contain reporting or recordkeeping requirements subject to approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1980 (44 U.S.C. 3507).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would otherwise impede its full implementation. This rule is not intended to have retroactive effect unless so specified in the “Dates” paragraph of this preamble. Prior to any judicial challenge to the provisions of this rule or the application of its provisions, all applicable administrative procedures must be exhausted. In the Food Stamp Program, the administrative procedures are as follows: (1) For Program benefit recipients—State administrative procedures issued pursuant to 7 U.S.C. 2020(e)(1) and 7 CFR 273.15; (2) for State agencies—administrative procedures issued pursuant to 7 U.S.C. 2023 set out at 7 CFR 276.7 for rules related to non-quality control (QC) liabilities or 7 CFR Part 283 for rules related to QC liabilities; and (3) for Program retailers and wholesalers—administrative procedures issued pursuant to 7 U.S.C. 2023 set out at 7 CFR 278.8.

In a State where food stamp benefits are issued using an Electronic Benefit Transfer System (EBT), Food Stamp Program (FSP) participants purchase food by swiping their EBT card through a point-of-sale (POS) machine at an authorized retailer. In the transaction, benefits move from the participants' accounts to the retailers' bank accounts. During normal EBT transaction processing, settlement of the transaction is completed when the transaction acquirer, typically a retail food store, has been properly credited for an amount equal to the amount debited from the household's benefit allotment. System malfunctions can cause an interruption to this process, resulting in a settlement condition that does not reflect the original transaction. Proposed regulations were published in the Federal Register on May 19, 1998 at 63 FR 27511 to change the way in which certain EBT error conditions are handled. Because of the complex nature of this issue and the substantive comments received to the proposed rule, the Department published an interim rule rather than a final rule in order to obtain further comments. The interim rule, published in the Federal Register September 9, 1999 at 64 FR 48933, implemented the proposed rule with some substantive changes as a result of comments received on the proposed rule.

The interim rule requires State agencies to make adjustments to correct out-of-balance settlement conditions that do not reflect original EBT transactions as a result of system malfunctions. In cases where a store is not credited for the full transaction amount, the interim rule requires State agencies to make an adjustment by debiting the client household's account, provided a concurrent notice is sent to the household. The interim rule also requires State agencies to debit a household's future month's benefits to complete an adjustment.

Apart and separate from system error adjustments, changes were also implemented for handling re-presentations when the system host computer cannot be accessed and there are insufficient funds in the household's account to cover a manual transaction. Readers should refer to the proposed and interim regulations for a more complete understanding of this final action.

This final rule reflects further revisions to the regulations, taking into consideration all comments received on the interim rule. Comments on the interim rule were solicited through November 8, 1999. Seventeen comment letters were received in response. Individual comments were received from twelve State agencies. Of the remaining letters, 2 were from EBT processors, 1 was from a retailer association, 1 was from an alliance of States, networks, financial institutions and retailers, and 1 was from a credit card company.

In general, the commenters supported the Department's efforts to streamline the adjustment process for certain types of system errors. However, the commenters still believe that the Department did not go far enough in doing so and that the EBT adjustment policy should be further simplified to more closely mirror procedures used to correct system errors in the commercial environment. The major comments are discussed below.

There is a significant difference between adjustments in an EBT environment and adjustments in a commercial environment. Processors treat commercial adjustments as routine corrections which do not require special notification to customers. However, commercial debit card customers do have protections found in Regulation E at 12 CFR part 205 (hereinafter “Reg. E”), that food stamp clients do not have. One important protection is the requirement that commercial debit card users receive monthly statements summarizing their account activities. The monthly statement provides the account holder notification after the fact that an adjustment was processed to the account. However, food stamp EBT users were explicitly exempted from Reg. E with the enactment of the Personal Responsibility and Work Opportunity Reconciliation Act of 1996, Pub. L. 104-193 (PRWORA).

Requirements set forth in the Food Stamp Act of 1977, as amended, 7 U.S.C. 2019(e)(10), (FSA), and in the FSP regulations, require client notifications and rights to appeal when negative actions are taken. Because debit adjustments against a food stamp client's EBT account can be viewed as a type of adverse action, the same notice and appeal rights must be applied in these circumstances. The State agencies and other stakeholders continue to raise this as a primary concern due to the potential costs associated with notification and the fair hearing process. However, because of the statutory and regulatory provisions set up to protect food stamp households in situations of adverse action, and the gap left without the customer protections from Reg. E, these requirements remain unchanged in the final regulation.

Several commenters expressed concern that there needs to be sufficient training for retailers and third party processors on how the adjustment rule will be implemented, especially those aspects of the rule dealing with liabilities and timeframes. Although not addressed in the regulation, the Department will work with State agencies to ensure that the appropriate level of information is made available to retailers and third party processors. We will also work with State agencies to determine how best to disseminate that information.

The interim rule defined business days as Automated Clearing House (ACH) days. Two commenters requested that instead of ACH days, we define business days as calendar days other than Saturdays, Sundays or Federal holidays. We have made this change at 7 CFR 274.12 (f)(4)(ii)(A) to make the rule language more universal. Another commenter requested that we clarify all references to “days” as either “calendar” or “business” days. Where appropriate, we have done so throughout the final rule.

The interim rule requires a debit adjustment from a recipient's account to be made from a future month's benefit, i.e., benefits that are not in the account at the time the initial adjustment is attempted, but are issued in subsequent months. This would apply in situations where either: (1) No benefits are available in the client account when the adjustment is attempted, or (2) only a portion of the benefits required for the full adjustment is available at the time the adjustment is attempted.

Two commenters provided general support of collection against future month's benefits. One commenter, however, asked for clarification on what was meant in the interim rule by requiring State agencies to collect from future months in which there has been a break in benefits. In the interim rule, State agencies are required to complete an outstanding adjustment that exists for a household that comes back on to the FSP after being off the Program for a period of time. This would require debiting the household's account in a month other than when the error occurred, i.e., use their future month's benefits.

Two commenters suggested limiting the number of months processors must attempt adjustments against a client's account, e.g., 1 future month, before the adjustment debt is canceled. Limiting the number of months an adjustment must be carried over until it is satisfied reduces the length of time State agencies and processors must track and account for an adjustment. Consequently, State agencies will also be relieved of tracking adjustments that cannot be collected from a household that leaves the FSP, regardless of whether that household returns to the FSP at a future date.

The Department is convinced that limiting the length of time the State agency may attempt an adjustment to one future month greatly reduces costs and makes this operation much more manageable. The Department is further convinced that this change will not significantly impact the number of adjustments that can be completed for the full amount. This is consistent with data that shows the average EBT transaction amount is $20, and therefore, most adjustments will be fully satisfied after going against no more than one future month's issuance. The final rule reflects this change.

At 7 CFR 274.12(f)(4)(ii), the interim rule states that, by definition, the amount of an adjustment cannot differ from the value of the original transaction. In response to three commenters, we are removing this language from the rule because it does not account for the possibility of partial adjustments in the current month, and again in future months. This language becomes more problematic now that we are limiting the State agencies' access to one future month's benefits to make an adjustment. In some cases, it is possible that the State agency will not be able to collect anything from a household, or only a portion of a total adjustment because the household has left the FSP, or they have a minimal benefit issuance that will not cover the full adjustment in the next month.

However, the Department is clarifying that we are not requiring State agencies to settle partial adjustments to retailer accounts. We have been informed that many acquirers' systems cannot accept partial adjustment amounts that do not match the original error transaction and prefer receiving no credit rather than a partial credit. In cases where the State agency chooses not to settle a partial adjustment to the acquirer, the adjustment amount must be returned to the household account.

Another commenter raised the concern that making a partial adjustment in the current month, then another partial adjustment in the next month is problematic. This is another example where tracking and settling the adjustment becomes complicated by the likelihood of multiple transactions to complete a full adjustment. The suggested solution from the commenter was to place a hold on a partial adjustment available in the current month, then move the funds at one time, as a single adjustment, after the next month's benefits are issued. This reduces the number of transactions required to make an adjustment when going against a future month's benefits. We can see the merit in this approach and will allow State agencies to handle the process in this way, so long as the notification to households: (1) Is sent at the time the initial hold is placed on the current month's remaining available funds, if any; (2) clearly states the full adjustment amount; and (3) advises the household that any amount still owing is subject to collection from the household's next future month's benefits. To reduce the possibility of creating a hardship on the household, the processor must place a hold on whatever portion of the adjustment is available in the current month rather than wait to debit the entire adjustment amount from the household's next month's issuance.

Two commenters suggested dropping the language at 7 CFR 274.12(f)(4)(ii), which provides that “[a] State agency shall make adjustments to an account after the availability date * * *,” because it implies that adjustments can never be made before the availability date. We have re-worded this paragraph to clarify that State agencies must make adjustments to correct system errors and that those adjustments may be made after the availability date. This distinguishes system error adjustments from other types of adjustments to client EBT accounts which may not be made after the benefit availability date.

The Department will require State agencies to amend training materials to disclose information to households about adjustments, including the possibility that an adjustment can be made against a future month's benefit. Training materials must also inform households of their right to a fair hearing if they do not feel that the adjustment is warranted and their right to receive a credit for the adjustment amount pending a fair hearing decision. Although one commenter questioned the sense of allowing State agencies a grace period to make changes to training materials, we have not changed the rule. State agencies may grandfather disclosure information on adjustments into their training materials if they have EBT systems that have been operational for one year from the date of this publication. However, as we discuss below, whenever a household's account is debited to make an adjustment, the State agency must provide the household concurrent notification of their rights to appeal and to provisional credits, including the possibility of adjustment from the next month's benefits.

When an adjustment will adversely affect the household, the interim rule requires State agencies to send a concurrent notice at the time the action is taken rather than an advance notice which must be sent 10 days before an action is taken. The concurrent notice gives households the right to a fair hearing and the right to be credited for the adjustment amount pending the outcome of the fair hearing. The majority of comments received on this subject continue to disagree with the notice requirement. However, as mentioned above, such notification is mandated by the FSA. Thus, the final rule remains unchanged in requiring concurrent notice to households. These notices must contain the level of detail described in current regulations at 7 CFR 273.13, i.e., State agencies are required to include information about the circumstances which resulted in the adverse action. State agencies are encouraged to include as much detail about the transaction—date, time and location—as possible, since such information could reduce calls to the help desk as well as requests for fair hearings and provisional credits.

Several commenters relayed concern that only one notice be required, even when partial adjustments are necessary from future months to recoup the full adjustment amount. It is the intent of this rule that only one notice be sent to a household informing it of the error and disclosing the full adjustment amount. The State agency must send the notice concurrent to taking initial action on the adjustment. Subsequent transactions to move the funds or otherwise complete the adjustment do not require additional household notification. It should be noted that all actions taken to reduce the household's allotment are subject to notice, including the correction of an erroneous adjustment that first went in the household's favor. No notice is necessary if an adjustment is a credit to the household account.

The household has 90 days from the date of the notice to request a fair hearing. However, if the request is received within 10 days from the date of the notice, the household must be granted a provisional credit pending the fair hearing decision. Three commenters believe that merchants and/or processors need to have input into the fair hearing process. There is no prohibition against parties other than the State agency and the FSP households having input into the fair hearing process. We encourage State agencies to ensure that all parties involved in resolving an error have access to the fair hearing process.

Several comments were received relating to provisional credits pending fair hearing determination. There continues to be considerable confusion about how to handle provisional credits, specifically how to handle claims of system errors and how provisional credits should be funded. Commenters also continue to have questions regarding liabilities for provisional credits in various circumstances.

First, the Department is clarifying that provisional credits are not required for denied system error claims initiated by client households. For example, a household claims that they are missing benefits from the EBT account as a result of a retailer's system problem, but the alleged system error cannot be substantiated with settlement data. In this case, the State agency may deny the adjustment. However, in so doing, they must also inform the household of their right to a fair hearing. In such a case, if the household does request a fair hearing, the State agency is not required to make a provisional credit to the household pending the fair hearing decision.

Several commenters were also concerned with the complexity of the provisional credit process when a retailer requests an adjustment. The interim rule states that, when a client responds to a retailer-initiated adjustment by requesting a fair hearing and provisional credit, the State agency must notify the processor to initiate another adjustment to credit the recipient's account—presumably coming out of the retailer's account. This scenario becomes even further complicated in cases where the client's fair hearing is not upheld. At such time, the amount of the provisional credit must be debited from the client account and credited back to the retailer.

Many commenters expressed concerns about the problems associated with State agencies and their processors having to track adjustments back and forth between the retailer and household accounts pending a fair hearing decision. There was also concern expressed about the likelihood that a household may spend the provisional credit and leave the FSP before it could be determined that the adjustment was in error. To simplify the process and reduce the risk involved in instances of retailer-initiated adjustments, the Department will require State agencies to have their processors place a hold on the adjustment amount in the client account pending a timely request for a provisional credit.

If the household does not request a provisional credit within the 10-day timeframe allotted for doing so, the hold on the funds in the client account is released and the adjustment is made into the retailer's account. As discussed above, if there are insufficient funds to cover the full adjustment amount, the State agency may choose to maintain the hold until the next month's benefits are issued and settle the full adjustment amount. If the household does request the provisional credit, the hold is released and the funds remain in the client's account. Should the fair hearing decision go against the client, the adjustment amount will then be credited to the retailer's account.

Four commenters felt that it was unfair to make retailers liable for provisional credits. Three commenters asked that we specify where provisional credits are to come from. Three other commenters suggested that government sources rather than private sources fund provisional credits. We are not changing the source of provisional credits in the final rule. However, we believe that, by not requiring provisional credits in instances of denied client-initiated adjustments, and by requiring State agencies to put a hold on an adjustment until after the time when a household can request a provisional credit, we have simplified the adjustment process and reduced the retailers' liability for unwarranted provisional credits.

Four commenters supported the Department taking on the liability of funding credit adjustments to clients when the responsible retailers have left the FSP or otherwise refuse to fund a legitimate adjustment. The Department has determined that because these adjustments result from the State agency's system errors, the State is ultimately responsible for making the client whole in these instances. The number of these situations that are likely to occur are quite small given that adjustments occur infrequently and the majority of food stamp transactions take place in stores with historically low turnover in the FSP. Moreover, adjustment amounts as reported by retailers and processors are small. If a client household leaves the FSP before a credit adjustment has been completed for a retailer, the adjustment is discontinued. As was stated in the interim rule, collections made from clients that are not credited to retailers because they have left the FSP must be returned to the Department.

The interim rule distinguishes between adjustments generated by retailers and recipients. It allows the State agency 10 days from the date of the error transaction to complete an adjustment requested by a retailer and 5 days from the date a client household notifies the State agency or help desk to complete a client-initiated adjustment. Three commenters felt the timeframes to complete adjustments were too short; three others specified that the 5-day timeframe to complete a client-initiated adjustment was too short, given the actions that must take place and the number of participants inherent in the adjustment process. The processes described by the commenters include compilation of documentation, research, exchange of information, and making the adjustment. The suggestion was to extend the timeframe for client initiated adjustments from 5 days to 10 or 15 days.

We believe that most client-initiated adjustments will result in funds owed to the household. In these scenarios, recipients have suffered a loss through no fault of their own, ostensibly through a verifiable system error. However, we have been convinced that 5 days is not enough time to complete an investigation of a client-initiated adjustment request. Therefore, the Department is extending the timeframe for client-initiated adjustments from 5 days to 10 days, in order to provide sufficient time for the State agencies and the processors to complete error verification research and handle the adjustment properly. This timeframe also applies to circumstances where the State agency or other entity besides the household discovers an error which must be corrected by crediting the household's account. Such a correction must occur within 10 days from the time the error is discovered.

The Department does not believe that a case has been made to justify allowing additional time after the 10-day deadline to complete retailer-initiated adjustments. In response to three comments, we are clarifying the use of the word “completed” in the context of retailer-initiated adjustments to mean that the initial adjustment transaction, which will be a hold placed on the funds available in the client account, must be attempted as soon as possible within 10 days of the error transaction, and a concurrent notification must be sent to the household. The funds will not move until after the time has passed for a household to request a provisional credit. We understand that, in some cases, all or some portion of the full adjustment will have to be made from the next month's allotment. However, the household must be notified concurrent with the initial adjustment action. The State agency may not take action on any adjustment to debit a household's account if more than 10 days have passed since the error transaction occurred, except in cases when the action is initiated within the 10-day timeframe but the funds are not available in the current month and must be taken from the next month's benefit issuance.

Another comment was raised regarding the 180 days a client household has to notify the State agency of a system error and request an adjustment. Indications are that client households do not request adjustments this far from the date an alleged error occurred, primarily because EBT households do not receive account statements, and therefore, keep track of their account balances with their POS receipts. As such, it is more likely that they will discover the error soon after the transaction takes place.

Furthermore, many State agencies only keep transaction data on-line at the host computer for 90 days. To research an alleged error once the data has been moved off-line greatly increases the potential cost and administrative burden of the adjustment process. The Department is convinced that the 180-day timeframe is longer than necessary for households to request an adjustment and has reduced the timeframe to 90 days.

One commenter requested that the Department put specific deadlines on each participant in the adjustment, e.g., the retailer has a certain number of days to request the adjustment, then the processors have another specified timeframe to complete the process, and so on. The Department believes that such an approach would be difficult to track and administratively burdensome. We realize, however, that each of these participants has a responsibility to the others to handle their portion expeditiously if timeframes are to be met. We would recommend and expect that this level of detail be addressed in retailer and third party agreements.

One commenter wanted clarification on the ramifications of not meeting timeframes or otherwise complying with this rule. This rule will not impose specific penalties for non-compliance. As with other regulatory requirements, however, State agencies are required to ensure the processor's compliance and failure to do so may result in administrative sanctions by the Department against the State agency.

The Department received three comments relaying confusion about how re-presentation fits into the adjustment process. In fact, re-presentation regulations are separate and apart from adjustment rules, because State agencies now have access to a household's future month's benefit issuance to make an adjustment. The only time a State agency would need to consider re-presentation is in the event of insufficient funds to cover a manual transaction when the system host computer is down. Any references to re-presentation are used in the context of 7 CFR 274.12(e). There are no changes regarding re-presentations in the final rule from what was published in the interim rule.

This final rule is effective August 4, 2000. State agencies may begin implementing the rule August 4, 2000 but no later than January 2, 2001. State agencies that have already implemented EBT shall have one year in which to grandfather adjustment disclosure into their training materials according to 7 CFR 274.12(f)(10)(viii).

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-15-25, Amendment 39-10866 (63 FR 59206, November 3, 1998), that applies to ECD Model EC 135 helicopters, was published in the Federal Register on April 6, 2000 (65 FR 18010). That action proposed to require the following:

• Conducting a vibration survey and installing the Fenestron Shaft Retrofit Kit L535M3002 882;

• Installing double bearing supports and struts;

• Inspecting and, if necessary, replacing bearing attach hardware; and

• Increasing the repetitive inspection interval for the bearing supports and attach hardware to 50 hours time-in-service (TIS).

Interested persons have been afforded an opportunity to participate in the making of this amendment. No comments were received on 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.

The FAA estimates that 16 helicopters of U.S. registry will be affected by this AD. The 50-hour inspection will take approximately 2 work hours to complete. The average labor rate is $60 per work hour. ECD has stated in its ASB's that the baseline vibration measurements and initial installation of all new parts will be provided at no charge to the owner/operator. Assuming the helicopters are operated 900 hours TIS per year, the total cost impact of this AD on U.S. operators is estimated to be $34,560.

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

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

On April 24, 2000, a proposal to amend part 71 of the Federal Aviation Regulations (14 CFR part 71) to revise the Class E airspace at Barrow, AK, was published in the Federal Register (65 FR 21681). The proposal was necessary due to revisions to the instrument approaches to runway (RWY) 06 and RWY 24 at Wiley Post—Will Rogers Memorial Airport, Barrow, AK.

Interested parties were invited to participate in this rulemaking proceeding by submitting written comments on the proposal to the FAA. No public comments to the proposal were received, thus, the rule is adopted as written.

The area will be depicted on aeronautical charts for pilot reference. The coordinates for this airspace docket are based on North American Datum 83. The Class E airspace areas designated as 700/1200 foot transition areas are published in paragraph 6005 of FAA Order 7400.9G, Airspace Designations and Reporting Points , dated September 1, 1999, and effective September 16, 1999, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be revised and published subsequently in the Order.

This amendment to 14 CFR part 71 revises the Class E airspace at Barrow, AK, through the revisions of instrument approaches to the Wiley Post—Will Rogers Memorial Airport, Barrow, AK. The area will be depicted on aeronautical charts for pilot reference. The intended effect of this proposal is to provide adequate controlled airspace for IFR operations at Wiley Post—Will Rogers Memorial Airport, Barrow, AK.

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

On June 14, 2000, Airspace Docket No. 99-ASW-33, FR Doc. 00-14909, was published amending the legal description of J-25 between the Corpus Christi, TX, VORTAC and the San Antonio, TX, VORTAC (65 FR 37277). This rule inadvertently listed the true bearing between Corpus Christi, TX, and San Antonio, TX, as “166° .” The correct true bearing is “174°.” The correct true bearing was listed in the Notice of Proposed Rulemaking for this matter.

On June 2, 2000, Airspace Docket No. 97-ASO-18, FR Doc. 00-13750, was published establishing V-384 between Livingston, TN, and Volunteer, TN. This rule included a legal description for V-384, which inadvertently listed incorrect radials. This action corrects this situation by omitting the radials in the legal description for V-384, thereby eliminating the error.

In the Federal Register of May 6, 1994 (59 FR 23731), FDA issued a notice of availability of a preamendments class III devices strategy document. The strategy document set forth FDA's plans for implementing the provisions of section 515(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(i)) for preamendments class III devices for which FDA had not yet required premarket approval. FDA divided this universe of devices into three groups as referenced in the May 6, 1994, notice.

In the Federal Register of September 7, 1995 (60 FR 46718), FDA published a proposed rule to require the filing under section 515(b) of the act of a PMA or a notice of completion of a PDP for 43 preamendment class III devices, including the obstetric data analyzer. In accordance with section 515(b)(A)(2) of the act, FDA included in the preamble to the proposal the agency's tentative findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the premarket approval requirements of the act, and the benefits to the public from use of the device. The September 7, 1995, proposed rule also provided an opportunity for interested persons to submit comments on the proposed rule and the agency's findings. Under section 515(b)(2)(B) of the act, FDA provided an opportunity for interested persons to request a change in the classification of the device based on new information relevant to its classification. Any petition requesting a change in the classification of the devices was required to be submitted by September 22, 1995. The comment period closed January 5, 1996.

FDA received one citizen petition requesting a change in the classification of the obstetrical data analyzer. FDA reviewed the petition, identified a deficiency in the petition, and issued a deficiency letter on March 7, 1996, to the petitioner. From the petitioner's response to the deficiency letter, it was apparent that the petitioner had misinterpreted the September 7, 1995, proposed rule because he believed that it was about another device and not the obstetrical data analyzer. In light of this petition, FDA has amended the identification of the device in § 884.2050(a) by changing the first two sentences to read as follows: “An obstetric data analyzer (fetal status data analyzer) is a device used during labor to analyze electronic signal data obtained from fetal and maternal monitors. The obstetric data analyzer provides clinical diagnosis of fetal status and recommendations for labor management and clinical interventions.” With this clarifying change, FDA is proceeding to issue a final rule to require the filing of a PMA or a PDP for the obstetric data analyzer.

Under section 515(b)(3) of the act, FDA is adopting the findings as published in the proposed rule of September 7, 1995. As required by section by section 515(b) of the act, FDA published its findings regarding: (1) The degree of risk of illness or injury designed to be eliminated or reduced by requiring that these devices have an approved PMA or a declared completed PDP; and (2) the benefits to the public from the use of the device.

These findings are based on the reports and recommendations of the Obstetrical and Gynecological Devices Panel, an FDA advisory committee for the classification of the devices, along with any additional information FDA discovered. Additional information can be found in the proposed and final rules classifying the devices in the Federal Register of April 3, 1979 (44 FR 19894) and February 26, 1980 (45 FR 12682), respectively.

Under section 515(b)(3) of the act, FDA is adopting the findings as published in the preamble to the proposed rule and issuing this final rule to require premarket approval of the generic type of device, the obstetric data analyzer, by revising 21 CFR part 884.

Under the final rule, a PMA or a notice of completion of a PDP is required to be filed on or before October 3, 2000, for any obstetric data analyzer that was in commercial distribution before May 28, 1976, or that has been found by FDA to be substantially equivalent to such a device on or before October 3, 2000. An approved PMA or a declared completed PDP is required to be in effect for any such devices on or before 180 days after FDA files the application. Any other obstetric data analyzer that was not in commercial distribution before May 28, 1976, is required to have an approved PMA or a declared completed PDP in effect before it may be marketed.

If a PMA or a notice of completion of a PDP for an obstetric data analyzer is not filed on or before the 90th day past the effective date of this regulation, that device will be deemed adulterated under section 501(f)(1)(A) of the act (21 U.S.C. 351(f)(1)(A)), and commercial distribution of the device will be required to cease immediately. The device may, however, be distributed for investigational use, if the requirements of the investigational device exemption (IDE) regulations (21 CFR part 812) are met.

Under § 812.2(d) of the IDE regulations, FDA hereby stipulates that the exemptions from the IDE requirements in § 812.2(c)(1) and (c)(2) will no longer apply to clinical investigations of the obstetric data analyzer. Further, FDA concludes that investigational obstetric data analyzers are significant risk devices as defined in § 812.3(m) and advises that, as of the effective date of § 878.3530(c), the requirements of the IDE regulations regarding significant risk devices will apply to any clinical investigation of an obstetric data analyzer. For any obstetric data analyzer that is not subject to a timely filed PMA or PDP, an IDE must be in effect under § 812.20 on or before 90 days after the effective date of this regulation or distribution of the device must cease. FDA advises all persons presently sponsoring a clinical investigation involving the obstetric data analyzer to submit an IDE application to FDA no later than 60 days after the effective date of this final rule to avoid the interruption of ongoing investigations.

The agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (Public Law 96-354), as amended by subtitle D of the Small Business Regulatory Fairness Act of 1996 (Public Law 104-121) and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is consistent with the regulatory philosophy and principles identified in the Executive Order. In addition, the final rule is not a significant regulatory action as defined by the Executive Order and so is not subject to review under the Executive Order.

If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because FDA believes that there is little or no interest in marketing these devices, the agency certifies that the final rule, if issued, will not have a significant impact on a substantial number of small entities. Therefore, under the Regulatory Flexibility Act, no further analysis is required.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires that agencies prepare a written statement of anticipated costs and benefits before proposing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million in any one year (adjusted annually for inflation). The Unfunded Mandates Reform Act does not require FDA to prepare a statement of costs and benefits for the final rule, because the proposed rule is not expected to result in any 1-year expenditure that would exceed $100 million adjusted for inflation.

FDA concludes that this final rule contains no new collections of information. The premarket approval program information collection is approved by the Office of Management and Budget (OMB) under OMB Control No. 0910-0231. Therefore, clearance by under the Paperwork Reduction Act of 1995 is not required.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies 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. Accordingly, the agency has concluded that the rule does not contain policies that have federalism implications as defined in the order and, consequently, a federalism summary impact statement is not required.

On June 5, 1997, the Treasury Department and the IRS published a notice of proposed rulemaking (REG-252487-96) under section 671 of the Internal Revenue Code (Code) in the Federal Register (62 FR 30785). Comments responding to the notice were received and a public hearing was held on August 27, 1997. After consideration of the comments, the proposed regulations under section 671 were re-issued as proposed (64 FR 43323) and temporary regulations (64 FR 43267) on August 10, 1999.

The proposed and temporary regulations provide a definition of grantor for purposes of part I of subchapter J, chapter 1 of the Code. No comments were received in response to the Notice of Proposed Rulemaking published on August 10, 1999, in the Federal Register , and no one requested to speak at the public hearing scheduled for November 2, 1999. Accordingly, the public hearing was canceled on October 28, 1999 (64 FR 58006). This document finalizes the proposed regulations and removes the temporary regulations.

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

The principal author of these regulations is James A. Quinn of the Office of the Assistant Chief Counsel (Passthroughs and Special Industries). However, other personnel from the IRS and Treasury Department participated in their development.

This document is available as an electronic file on The Federal Bulletin Board the day of publication in the Federal Register . By modem, dial 202/512-1387 and type “/GO FAC,” or call 202/512-1530 for disk or paper copies. This file is available for downloading without charge in ASCII and Adobe Acrobat® readable (*.PDF) formats. For Internet access, the address for use with the World Wide Web (Home Page), Telnet, or FTP protocol is: fedbbs.access.gpo.gov. This document and additional information concerning the programs of the Office of Foreign Assets Control are available for downloading from the Office's Internet Home Page: http://www.treas.gov/ofac, or in fax form through the Office's 24-hour fax-on-demand service: call 202/622-0077 using a fax machine, fax modem, or (within the United States) a touch-tone telephone.

On December 3, 1999, President Clinton signed into law the Foreign Narcotics Kingpin Designation Act, Pub. L. No. 106-120, title VIII, 113 Stat. 1606, 1626-1636 (1999) (to be codified at 21 U.S.C. 1901-1908, 8 U.S.C. 1182(a)(2)(C)) (the “Act”), which provides authority for the application of sanctions to significant foreign narcotics traffickers and their organizations operating worldwide. Section 805(b) of the Act blocks all property and interests in property within the United States or within the possession or control of any United States person, which are owned or controlled by significant foreign narcotics traffickers, as identified by the President, or foreign persons designated by the Secretary of the Treasury, in consultation with the Attorney General, the Director of Central Intelligence, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, and the Secretary of State, because they are found to be:

(1) Materially assisting in, or providing financial or technological support for or to, or providing goods or services in support of, the international narcotics trafficking activities of a significant foreign narcotics trafficker or foreign persons designated by the Secretary of the Treasury pursuant to section 805(b) of the Act;

(2) Owned, controlled, or directed by, or acting for or on behalf of, a significant foreign narcotics trafficker or foreign persons designated by the Secretary of the Treasury pursuant to section 805(b) of the Act; or

(3) Playing a significant role in international narcotics trafficking.

Significant foreign narcotics traffickers and persons coming within any of the above three categories are referred to as specially designated narcotics traffickers.

Section 805(e)(1) of the Act authorizes the Secretary of the Treasury, in consultation with the Attorney General, the Director of Central Intelligence, the Director of the Federal Bureau of Investigation, the Administrator of the Drug Enforcement Administration, the Secretary of Defense, and the Secretary of State, to take such actions as may be necessary to carry out the Act, including the promulgation of rules and regulations permitted under the Act. Section 806 of the Act authorizes the Secretary of the Treasury to issue regulations and orders as may be necessary for the exercise of authorities granted by the Act.

In implementation of the Act, the Office of Foreign Assets Control of the Department of the Treasury is issuing the Foreign Narcotics Kingpin Sanctions Regulations, 31 CFR Part 598 (the “Regulations”). These Regulations are separate from, and independent of, the Narcotics Trafficking Sanctions Regulations, 31 CFR Part 536, which implement the national emergency declared in Executive Order 12978 of October 21, 1995, with respect to significant foreign narcotics traffickers centered in Colombia. See § 598.101. Sanctions imposed and persons named as specially designated narcotics traffickers pursuant to 31 CFR part 536 are not affected by this part 598. Section 809 of the Act, which amends section 212(a)(2)(C) of the Immigration and Nationality Act, is not implemented by these Regulations.

Subpart B of the Regulations implements section 805 of the Act. Specifically, section 598.201 implements section 805(a) of the Act by providing that specially designated narcotics traffickers are subject to any and all sanctions authorized by the Act until revoked or waived. Section 598.202 implements section 805(b) of the Act by providing that property and interests in property owned or controlled by specially designated narcotics traffickers and within the United States or within the possession or control of a United States person are blocked. Section 598.203 of the Regulations implements section 805(c)(1) of the Act by prohibiting transactions and dealings by U.S. persons or within the United States in property or interests in property of specially designated narcotics traffickers. Section 598.204 implements section 805(c)(2) of the Act by prohibiting transactions that have the effect of evading or avoiding, and attempts or conspiracies to violate, the prohibitions set forth in this part. Sections 598.205 and 598.206 of the Regulations detail the effect of transfers of blocked property in violation of the Regulations and the required holding of blocked property in interest-bearing accounts.

Subpart C of the Regulations implements section 808 of the Act and defines key terms used throughout the Regulations. Subpart D of the Regulations sets forth interpretive sections regarding the general prohibitions of subpart B.

Transactions otherwise prohibited under this part but found to be consistent with U.S. policy may be authorized by a general license contained in subpart E or by a specific license issued pursuant to the procedures set forth in subpart D of part 501 of chapter V. The general licenses contained in subpart E include an authorization for U.S. financial institutions to debit blocked accounts for normal service charges. See § 598.506. Section 598.507 authorizes the provision of certain legal services, provided that receipt of payment for such services is specifically licensed.

Subpart F of the Regulations implements sections 806(a)-(b) of the Act by reference to the Reporting and Procedures Regulations in subpart C of 31 CFR part 501, which set forth provisions relating to required records and reports. Subpart G implements section 807 of the Act by describing the civil and criminal penalties applicable to violations of the Regulations. Specifically, section 598.701 sets forth the civil and criminal penalties prescribed in sections 807(a)-(b) of the Act, and section 598.706 implements section 807(c) of the Act by providing that civil penalties shall be subject to judicial review only to the extent provided in 5 U.S.C. 702.

Subpart H provides certain administrative procedures applicable to this part and implements others by reference to the Reporting and Procedures Regulations in subpart D of 31 CFR part 501, which contain provisions relating to administrative procedures. Section 598.802 implements section 805(e)(3) of the Act by clarifying that records or information obtained or created in the implementation of the Regulations are not subject to disclosure under section 552(a)(3) of the Freedom of Information Act (5 U.S.C. 552(a)(3)). Section 598.803 delegates to the Office of Foreign Assets Control those actions that the Secretary of the Treasury is authorized to take pursuant to the Act. Subpart I of the Regulations sets forth a Paperwork Reduction Act notice.

In addition to adding a new part 598, the Office of Foreign Assets Control is revising its Reporting and Procedures Regulations contained in 31 CFR part 501 in implementation of certain provisions of the Act. Pursuant to section 805(e)(3) of the Act, section 501.805(a) is amended to add a note clarifying the inapplicability of section 552(a)(3) of the Freedom of Information Act.

In implementing the Regulations, the Office of Foreign Assets Control will seek to consult with foreign governments where appropriate. Because the Regulations involve a foreign affairs function, Executive Order 12866 and the provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date, are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in the Reporting and Procedures Regulations in 31 CFR part 501. Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information were previously approved by the Office of Management and Budget (“OMB”) under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(8), the Coast Guard finds that good cause exists for not publishing an NPRM. Good cause exists for not publishing an NPRM due to the date the Application for Approval of Marine Event was received, there was insufficient time to draft and publish an NPRM. Special Local Regulations have been published for this event in 33 CFR 100.121 for the same date. The location of this year's event has been moved 3.5 nautical miles north in the vicinity of Barrytown Reach, north of the Kingston-Rhinecliff Bridge. The safety zone encompasses about 800 yards of Barrytown Reach and is about 1,000 yards smaller than the permanent area, and it is also scheduled to start and finish 30 minutes earlier as compared to the current regulations. Further, it is a annual, local event, recreational vessels may still transit to the east of the zone during the event, the zone is only in affect for 2 hours, and commercial traffic is not heavy in this area of the Hudson River. It is expected that no more than 1 or 2 commercial vessels may be affected by this event. Due to the publication of this annual event in the Local Notice to Mariners, commercial traffic will be able to adjust their transit time to arrive before or after the event. Any delay encountered in this regulation's effective date would be unnecessary and contrary to public interest since immediate action is needed to close the waterway and protect swimmers and the maritime public from the hazards associated with 500 athletes competing in the swimming portion of the Hudson Valley Triathlon.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . This is due to the following reasons: Special Local Regulations have been published for this event in 33 CFR 100.121 for the same date. The location of this year's event has been moved 3.5 nautical miles north in the vicinity of Barrytown Reach, north of the Kingston-Rhinecliff Bridge. It encompasses about 800 yards of Barrytown Reach and is about 1,000 yards smaller than the permanent area, it is also scheduled to start and finish 30 minutes earlier, as compared to the current regulations. Further, it is a annual local event, recreational vessels may still transit to the east of the zone during the event, the zone is only in effect for 2 hours, and commercial traffic is not heavy in this area of the Hudson River. It is expected that no more than 1 or 2 commercial vessels may be affected by this event. Due to the publication of this annual event in the Local Notice to Mariners, commercial traffic will be able to adjust their transit time to arrive before or after the event. Any delay encountered in this regulation's effective date would be unnecessary and contrary to public interest since immediate action is needed to close the waterway and protect swimmers and the maritime public from the hazards associated with 500 athletes competing in the swimming portion of the Hudson Valley Triathlon.

The Coast Guard has received an application to hold a triathlon swim on the waters of the Hudson River. This regulation establishes a safety zone in all waters of the Hudson River, in the vicinity of Ulster Landing, bound by the following points: 41°59′52.5′′ N 073°56′34.2′′ W (about 150 yards south of Hudson River Lighted Buoy 82 (LLNR 38325)), thence to 42°00′15.1′′ N 073°56′25.2′′ W, thence to 42°00′05.4′′ N 073°56′41.9′′ W, thence to 42°00′03.7′′ N 073°56′43.1′′ W, (NAD 1983), thence back to the point of beginning, in the northern end of Barrytown Reach. The safety zone is in effect from 6:30 a.m. (e.s.t.) until 8:30 a.m. (e.s.t.) on Sunday, July 9, 2000. There is no rain date for this event. The safety zone prevents vessels from transiting a portion of the Hudson River. It is needed to protect swimmers and boaters from the hazards associated with 500 swimmers competing in a confined area of the Hudson River. Recreational vessels can still transit to the east of the zone during the event and will not be precluded from mooring at or getting underway from recreational piers in the vicinity of the zone. Commercial vessels will be precluded from transiting the area because the safety zone encompasses about 800 yards of Barrytown Reach and there is no viable alternative route. Public notifications will be made prior to the event via the Local Notice to Mariners.

Special Local Regulations have been published for this event in 33 CFR 100.121 for the same date. The location of this year's event has been moved 3.5 nautical miles north in the vicinity of Barrytown Reach, north of the Kingston-Rhinecliff Bridge. It encompasses about 800 yards of Barrytown Reach and is about 1,000 yards smaller than the permanent area, it is also scheduled to start and finish 30 minutes earlier, as compared to the current regulations.

This final rule is not a significant regulatory action under section 3(f) of Executive Order 12866 and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. It has not been reviewed by the Office of Management and Budget under that Order. It is not significant under the regulatory policies and procedures of the Department of Transportation (DOT) (44 FR 11040, February 26, 1979). The Coast Guard expects the economic impact of this final rule to be so minimal that a full Regulatory Evaluation under paragraph 10e of the regulatory policies and procedures of DOT is unnecessary. This finding is based on the following: This is an annual marine event currently published in 33 CFR 100.121, this final rule will close a smaller portion of the Hudson River, and the minimal time on a Sunday morning that vessels will be restricted from the zone. Recreational vessels may still transit to the east of the zone during the event and will not be precluded from mooring at or getting underway from recreational piers in the vicinity of the zone. Commercial vessels can plan their transits up the river around the time the zone is in effect as they will have advance notice of this annual event, and advance notifications which will be made.

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

For reasons discussed in the Regulatory Evaluation above, the Coast Guard certifies under section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) that this final rule will not have a significant economic impact on a substantial number of small entities.

This final rule does not provide for a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

The Coast Guard has analyzed this final rule under the principles and criteria contained in Executive Order 13132 and has determined that this final rule does not have implications for federalism under that Order.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) [Pub. L. 104-4, 109 Stat. 48] requires Federal agencies to assess the effects of certain regulatory actions on State, local, and tribal governments, and the private sector. UMRA requires a written statement of economic and regulatory alternatives for rules that contain Federal mandates. A Federal mandate is a new or additional enforceable duty imposed on any State, local, or tribal government, or the private sector. If any Federal mandate causes those entities to spend, in the aggregate, $100 million or more in any one year, the UMRA analysis is required. This final rule does not impose Federal mandates on any State, local, or tribal governments, or the private sector.

The Coast Guard considered the environmental impact of this final rule and concluded that under figure 2-1, paragraph 34(g), of Commandant Instruction M16475.1C, this final rule is categorically excluded from further environmental documentation. This rule fits paragraph 34(g) as it establishes a safety zone. A “Categorical Exclusion Determination” is available in the docket for inspection or copying where indicated under ADDRESSES.

The Clean Air Act (CAA) establishes requirements for State Implementation Plans for areas that have not attained the national ambient air quality standards for ozone. Section 182(b)(2) of the CAA expands the applicability of RACT to sources of VOC equal to or greater than 50 tons per year. To help the states identify VOC control options, the CAA required EPA to publish alternative control technology (ACT) documents for a variety of VOC sources. EPA published an ACT document for Bakery Oven Emissions (EPA 453/R-92-017) in December, 1992. Massachusetts has identified several large commercial bakeries that are greater than 50 ton per year sources and as such are subject to RACT. Massachusetts adopted 310 CMR 7.18(29), Bakeries to reduce VOC emissions from bakeries.

On March 29, 1995, the Commonwealth of Massachusetts submitted a formal revision to its SIP. The SIP revision amends 310 CMR 7.00 by adding Section 310 CMR 7.18(29), Bakeries.

The adopted air pollution control regulation, 310 CMR 7.18(29) Bakeries, establishes RACT for bakery facilities. The rule applies to any person who owns, leases, operates or controls any bakery which has the potential to emit, before the application of air pollution control equipment, equal to or greater than 50 tons per year of VOC. The rule establishes as RACT that affected bakeries reduce VOC emissions from baking ovens by 81% by weight. The 81% overall reduction requirement is based on a minimum capture efficiency of 90% combined with a minimum destruction efficiency of 90%. According to the Massachusetts Department of Environmental Protection, affected bakeries in the Commonwealth will be installing catalytic oxidation to achieve RACT level VOC reductions. Massachusetts' rule contains the following additional provisions:

1. Exemption for small bakeries : This section exempts bakeries that can demonstrate that, since January 1, 1990, the bakery has not emitted, before the application of air pollution control equipment, greater than or equal to 50 tons per year of VOC. Small bakeries must obtain a permit restriction which restricts potential emissions to below 50 tons per year;

2. Exemptions for small ovens : This section exempts individual baking ovens (at an applicable facility) which have not emitted since January 1, 1990, before application of air pollution control equipment, greater than 25 tons of VOC in any calendar year from the RACT requirement and plan submittal requirements. (small ovens must still comply with the recordkeeping and testing requirements);

3. Plan submittal requirements : This section requires bakeries to submit an emission control plan to the Massachusetts DEP for approval (note that the emission limit requirement in 310 CMR 7.18(29)(e) is directly enforceable under the SIP whether or not a bakery has submitted a plan.);

4. Recordkeeping requirements : This section requires bakeries to maintain records necessary to demonstrate compliance for at least five years, including: monthly records to determine emissions from each oven, and hourly (or continuous ) records of control equipment operating parameters such as temperature, pressure drop, or other parameters to assure continuous compliance; and

5. Testing Requirements : This section requires bakeries to perform tests to demonstrate compliance upon request of the Massachusetts DEP.

Facilities are required to comply with RACT by May 31, 1995.

EPA's evaluation is detailed in a memorandum, entitled “Technical Support Document for Massachusetts Air Pollution Control Regulation, 310 CMR 7.18(29), Bakeries.” EPA considers the Massachusetts bakery regulation to represent a reasonable level of control for all affected facilities. In approvals granted by Massachusetts DEP of emission control plans submitted by individual bakeries, Massachusetts DEP evaluates the feasibility of higher reduction rates (e.g. 95% minimum oxidizer destruction efficiency) and imposes those if determined to be feasible.

EPA is approving Section 310 CMR 7.18(29), Bakeries. The EPA is publishing this action without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comments. However, in a separate document in this Federal Register publication, the EPA is proposing to approve the SIP revision should adverse or critical comments be filed. This action will be effective September 5, 2000, unless by August 4, 2000, relevant adverse comments are received.

If the EPA receives such comments, this action will be withdrawn before the effective date by publishing a subsequent document that will withdraw the final action. All public comments received will be addressed in a subsequent final rule based on this action serving as a proposed rule. The EPA will not institute a second comment period on this action. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective September 5, 2000.

Nothing in this action should be construed as permitting or allowing or establishing a precedent for any future request for revision to any State implementation plan. Each request for revision to the State implementation plan shall be considered separately in light of specific technical, economic, and environmental factors and in relation to relevant statutory and regulatory requirements.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule 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 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

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

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

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 5, 2000. 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).) EPA encourages interested parties to comment on the proposed rule rather than file a petition for review in the Court of Appeals.

We are approving the repeal of Oregon's Consumer Products Rules, the repeal of the Architectural Coatings Rules, and a revision and partial repeal of the Motor Vehicle Refinishings Rules.

Consumer and Commercial Products Rules reduce Volatile Organic Compound (VOC) emissions from categories of products such as consumer products, architectural coatings, automobile refinishing coatings, aerospace coatings, aerosol spray paints, industrial cleaning solvents, and metal furniture coatings. VOCs contribute significantly to the formation of ground-level ozone.

Ozone is an odorless, colorless gas composed of three atoms of oxygen. Ozone is major component of smog and causes adverse health and environmental impacts when present in high concentrations at ground level. Ground-level ozone is not emitted directly into the air but forms when VOCs and Nitrogen Oxides (NO X ) mix and react chemically in the presence of sunlight. Therefore, ozone is controlled by reducing VOC or NO X emissions.

The federal Clean Air Act requires EPA to set health-based standards for six commonly occurring air pollutants, including ozone. These standards are referred to as the National Ambient Air Quality Standards (NAAQS). The Clean Air Act also requires each state to develop and implement a SIP for meeting and maintaining the NAAQS within their state.

The Clean Air Act Amendments of 1990 included a new requirement (Section 183(e)) for regulating consumer and commercial products. Section 183(e) directs EPA to conduct a study of VOC emissions from consumer and commercial products. Based on this study, EPA is required to schedule for regulation the categories of products that have the potential to contribute to ozone nonattainment. EPA completed the study and a report to Congress in 1995 and also published the schedule for regulation in a Federal Register document (60 FR 15264) on March 23, 1995. The schedule was subsequently revised on March 18, 1999 (64 FR 13422).

In the past, the Portland area failed to meet the ozone NAAQS and was designated as a non-attainment area in 1978. The Governor of Oregon appointed a Task Force in 1992 to ensure the maintenance of the ozone standard. One of the strategies the Task Force selected was to reduce VOCs from consumer and commercial products. The promulgation of EPA's Consumer and Commercial Products Rules was delayed beyond the time when Portland needed the VOC reductions to meet its emission targets. Therefore, in 1995, Oregon adopted its own rules for Portland for Consumer Products, Architectural Coatings, Aerosol Spray Paint, and Motor Vehicle Refinishings in the Portland Ozone Maintenance Plan. On May 19, 1997, after Oregon had demonstrated that the Portland area had attained the ozone NAAQS, EPA redesignated the area as an ozone attainment area and approved the maintenance plan as a part of the SIP (62 FR 27204).

Oregon developed its rules with the intention of repealing them when EPA's rules took effect. On September 11, 1998, EPA finalized federal rules for Consumer Products (63 FR 48819), Architectural Coatings (63 FR 48848), and Automobile Refinishing Coatings (63 FR 48806). These measures apply nationwide and provide consistency for the regulated community. In May of 1999, Oregon adopted revisions to their administrative rules to amend and repeal their Consumer and Commercial Products Rules.

a. General: EPA's national rules apply to the manufacturers, importers, and distributors (for the Consumer Products Rule) of the products, so VOC content is controlled at the source. Since Oregon's rules only applied in the Portland area, they also had to restrict the sale and commercial application of the products.

b. Consumer Products (OAR 340-022-0800 through OAR 340-022-0860) : The Consumer Products Rules establish VOC limits for a variety of household products such as hair sprays, air fresheners, windshield washer fluids, cleaners, and antiperspirants. Oregon's rules are more stringent than EPA's rules in two categories of products, windshield washer fluid and nail polish remover.

c. Architectural Coatings (OAR 340-022-1000 through OAR 340-022-1050): The Architectural Coatings Rules establish VOC limits for paint for all “stationary structures” (houses, industrial equipment, traffic markings, etc.). The EPA VOC limits are more stringent than Oregon in four categories (alkali resistant primers, swimming pool coatings, opaque below ground wood preservatives, and lacquer stains), while Oregon's limits are more stringent in nine categories (antenna coatings, calcimine recoaters, clear shellacs, concrete curing and sealing compounds, concrete surface retarders, conversion varnishes, faux finishes, stain controllers, and zone marking coatings).

EPA's rules allow manufacturers to produce high VOC coatings if they pay an “exceedance fee” of $2,500 per ton of VOC in excess of the applicable VOC content limit. EPA's rules also allow each manufacturer and importer to exempt the VOC used in small volume products. The exemption begins at twenty-five tons per year for each manufacturer and importer, but decreases to ten tons per year in 2002. Oregon's rules do not contain either of these provisions.

d. Aerosol Spray Paint (OAR 340-022-0900 through OAR 340-022-0950): The Aerosol Spray Paint Rules limit the VOC content of paint sold in aerosol cans. EPA's rules for aerosol spray paint is not scheduled to be promulgated until 2001. Therefore, this portion of Oregon's rules is retained.

e. Automobile Refinishing Coatings (OAR 340-022-0700 through OAR 340-022-0760): The Automobile Refinishing Coatings Rules set VOC limits for automotive coatings. Oregon's rules require painters to use efficient High Volume/Low Pressure (HVLP) spray guns and spray gun cleaning equipment to further reduce solvent emissions, which is not required in the EPA rules. Therefore, the provisions of Oregon's regulations regarding the use of HVLP spray guns and spray gun cleaning equipment are retained in the SIP. Additionally, EPA's rules exempt lacquer topcoats, while Oregon's rules do not.

ODEQ submitted a demonstration showing that the EPA rules will achieve VOC reductions at least as significant as the existing Consumer and Commercial Products Rules in the Portland Ozone Maintenance Plan (based on EPA's VOC reduction estimates published in the Final Rules). ODEQ's rules only apply to the Portland area, so noncomplying products inevitably leak into Portland from the outlying region. EPA's rules apply uniformly across the nation and consequently achieve a much higher degree of rule effectiveness. Therefore, Oregon's Consumer and Commercial Products Rules can be removed from the SIP with no deleterious effect on any NAAQS, Prevention of Significant Deterioration increment, or visibility in Class I areas.

The June 18, 1999 submittal included revisions to the VOC definitions in OAR 340-022-0102 and OAR 340-028-0110. The VOC definitions were revised to delist 17 compounds from the definitions of VOC. The delisted compounds are: difluoromethane (HFC-32); ethylfluoride (HFC-161); 1,1,1,3,3,3-hexafluoropropane (HFC-236fa); 1,1,2,2,3-pentafluoropropane (HFC-245ca); 1,1,2,3,3-pentafluoropropane (HFC-245ea); 1,1,1,2,3-pentafluoropropane (HFC-245eb); 1,1,1,3,3-pentafluoropropane (HFC-245fa); 1,1,1,2,3,3-hexafluoropropane (HFC-236ea); 1,1,1,3,3-pentafluorobutane (HFC-365mfc); chlorofluoromethane (HCFC-31); 1-chloro-1-fluoroethane (HCFC-151a); 1,2-dichloro-1,1,2-trifluoroethane (HCFC-123a); 1,1,1,2,2,3,3,4,4-nonafluoro-4-methoxy-butane (C 4 F 9 OCH 3 ); 2-(difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoropropane ((CF 3 ) 2 CFCF 2 OCH 3 ); 1-ethoxy-1,1,2,2,3,3,4,4,4-nonafluorobutane (C 4 F 9 OC 2 H 5 ); 2-(ethoxydifluoromethyl)-1,1,1,2,3,3,3-heptafluoropropane ((CF 3 ) 2 CFCF 2 OC 2 H 5 ); and methyl acetate. The proposed amendments also add a technical clarification that these VOC definitions relate to ground-level (tropospheric) ozone and not to ozone depleting reactions in the stratosphere.

EPA modified the federal definition of VOC in 40 CFR 51.100(s) by adding additional compounds that are exempted from the VOC definition due to their negligible photochemical reactivity. This SIP revision will make the state and federal definitions of VOC consistent.

While EPA's Consumer and Commercial Products Rules are slightly less stringent than ODEQ's rules as detailed above, ODEQ has demonstrated that the VOC reductions relied upon in the Portland Ozone Maintenance Plan will not be adversely affected by the substitution of EPA's national rules for Oregon's rules. Therefore, we are approving the repeal of Oregon's Consumer Products Rules, the repeal of the Architectural Coatings Rules, and a revision and partial repeal of the Motor Vehicle Refinishings Rules. The SIP revision to the VOC definitions will make the state and federal definitions consistent, and therefore we are also approving this revision.

The list below identifies the revisions we are approving and the rules we are repealing from the SIP, with the state effective date of the rules in parentheses. The effective date of Oregon's repeal of the Consumer Products Rules was June 10, 1999. The effective date of Oregon's revision and partial repeal of the Motor Vehicle Refinishings Rules was July 12, 1999. The effective date of Oregon's repeal of the Architectural Coatings Rules was March 13, 2000.

Please note that since these SIP revisions were adopted by the state, other modifications to Oregon's rules may have been adopted by the Environmental Quality Commission and submitted to the EPA for approval (e.g. the rule recodification package). Approval of the SIP revisions discussed in this action does not rescind any local rule amendments that were subsequently filed and submitted.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. However, in the proposed rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal to approve the SIP revision should adverse comments be filed. This rule will be effective September 5, 2000 without further notice unless the Agency receives adverse comments by August 4, 2000.

If the EPA receives such comments, then EPA will publish a notice withdrawing the final rule and informing the public that the rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. The EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 5, 2000 and no further action will be taken on the proposed rule.

A. Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. This action merely approves state law as meeting federal requirements and imposes no additional requirements beyond those imposed by state law. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). Because this rule approves pre-existing requirements under state law and does not impose any additional enforceable duty beyond that required by state law, it does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). For the same reason, this rule also does not significantly or uniquely affect the communities of tribal governments, as specified by Executive Order 13084 (63 FR 27655, May 10, 1998). This rule 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 (64 FR 43255, August 10, 1999), because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

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

The Congressional Review Act, 5 U.S.C. 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 September 5, 2000 unless EPA receives adverse written comments by August 4, 2000.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 5, 2000. 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).)

B. Oregon Notice Provision. During EPA's review of a SIP revision involving Oregon's statutory authority, a problem was detected which affected the enforceability of point source permit limitations. EPA determined that, because the five-day advance notice provision required by ORS 468.126(1) (1991) bars civil penalties from being imposed for certain permit violations, ORS 468 fails to provide the adequate enforcement authority that a state must demonstrate to obtain SIP approval, as specified in section 110 of the Clean Air Act and 40 CFR 51.230. Accordingly, the requirement to provide such notice would preclude federal approval of a section 110 SIP revision.

To correct the problem the Governor of Oregon signed into law new legislation amending ORS 468.126 on September 3, 1993. This amendment added paragraph ORS 468.126(2)(e) which provides that the five-day advance notice required by ORS 468.126(1) does not apply if the notice requirement will disqualify a state program from federal approval or delegation. ODEQ responded to EPA's understanding of the application of ORS 468.126(2)(e) and agreed that, because federal statutory requirements preclude the use of the five-day advance notice provision, no advance notice will be required for violations of SIP requirements contained in permits.

C. Oregon Audit Privilege. Another enforcement issue concerns Oregon's audit privilege and immunity law. Nothing in this action should be construed as making any determination or expressing any position regarding Oregon's Audit Privilege Act, ORS 468.963 enacted in 1993, or its impact upon any approved provision in the SIP, including the revision at issue here. The action taken herein does not express or imply any viewpoint on the question of whether there are legal deficiencies in this or any other Clean Air Act Program resulting from the effect of Oregon's audit privilege and immunity law. A state audit privilege and immunity law can affect only state enforcement and cannot have any impact on federal enforcement authorities. EPA may at any time invoke its authority under the Clean Air Act, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the Clean Air Act is likewise unaffected by a state audit privilege or immunity law.

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

We are approving Indiana's rule (IAC 8-13) that regulates emissions of VOCs from steel mill sinter plants in Lake and Porter Counties. Our approval makes the Indiana sinter plant rule part of the federally enforceable SIP under the Clean Air Act (Act).

Lake and Porter Counties are classified under the Act as severe nonattainment for ozone. High ozone levels are detrimental to human health and contribute to upper respiratory ailments such as asthma. The sintering process at steel mills emits significant amounts of VOC, and Indiana has identified reductions in emissions from the sintering process as making an important contribution toward improving air quality and attaining the ambient ozone air quality standard.

The SIP revision requirements are applicable to all steel mill sinter plant operations in Lake and Porter Counties. According to Indiana, there are four existing sinter plants operating in Lake and Porter Counties. Three are located in Lake County: LTV Steel Company, Inland Steel Company and U.S. Steel, Gary Works; and, one is located in Porter County: Bethlehem Steel.

The rule establishes three types of VOC emission limits for the period from May 1 through September 30 for sinter plant windbox exhaust gas VOC emissions: a seasonal cap, a maximum daily limit, and a lower daily limit for days on which an exceedance of the national ambient air quality standard for ozone is predicted to be likely. The emission limits are based on a VOC emission rate equal to twenty-five hundredths (0.25) pounds per sinter produced and a daily sinter production rate. In addition, from October 1 through April 30, sinter plant windbox exhaust gas VOC emissions are limited to thirty-six hundredths (0.36) pound per ton of sinter produced. The rule also contains control measure operation, maintenance, and monitoring requirements, and record keeping and reporting requirements.

The rule requires that by November 1, 1998, the owners or operators of the sinter plants mentioned above submit a report detailing, among other things, how the limits of the rule will be met. In addition, the rule requires the submission of a corrective action plan that will be implemented in the event of an exceedance, and a high ozone day action plan in the event that a high ozone day is predicted. At this time, all of the sinter plant operations covered by this rule have submitted the above documentation to the Indiana Department of Environment.

The rule requires that on or after January 1, 1999, the sinter plant operations comply with all the above requirements.

Indiana has codified its sinter plant rule at 326 Indiana Administrative Code (IAC) 8-13. The Indiana Pollution Control Board adopted the rule on March 4, 1998. The rule was filed with the Secretary of State on June 24, 1998, and became effective on July 24, 1998. The rule was published in the Indiana Register on August 1, 1998, at 21 IR 4195.

Indiana held three public hearings in Indianapolis, Indiana on the sinter plant rule on December 3, 1997, February 4, 1998, and March 4, 1998.

In this rulemaking action, we are approving Indiana's April 6, 1999, SIP revision request regarding steel mill sinter plant VOC controls (326 IAC 8-13) in Lake and Porter Counties.

The EPA is publishing this action without prior proposal because EPA views this as a noncontroversial revision and anticipates no adverse comments. However, in a separate document in this Federal Register publication, the EPA is proposing to approve the SIP revision should adverse written comments be received. This action will be effective without further notice unless EPA receives relevant adverse written comment by August 4, 2000. Should the Agency receive such comments, it will publish a notice informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no such comments are received, the public is advised that this action will be effective on September 5, 2000.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), 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 rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 ( Federalism ) and 12875 ( Enhancing the Intergovernmental Partnership ). 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule 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, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA, 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under section 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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 September 5, 2000 unless EPA receives adverse written comments by August 4, 2000.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 5, 2000. 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).)

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

We are approving as SIP revisions revised opacity limits for three processes at ALCOA Warrick Operations, which were submitted by IDEM on January 13, 2000. The revised limits allow higher opacity emissions during fluxing operations at three casting complexes. This action does not change mass emissions limits for these sources.

We are approving revised opacity limits for three processes at ALCOA Warrick Operations. ALCOA Warrick Operations is a primary aluminum smelter located in Newburgh, Indiana. Molten aluminum is transferred from the melt furnaces into the holding furnaces for final fluxing, then cast into slabs. There are no particulate matter (PM) control devices for these processes. Emissions are exhausted through ventilation hoods to the exhaust stacks for each holding furnace. The revised limits apply to the #1 Complex (Horizontal Direct Chill Casting, or HDC), the #8 Complex (Electromagnetic Casting, or EMC) and the #5 HDC complex. Each of these casting complexes contains two holding furnaces.

The revised limits for both the #1 complex and the #8 complex are contained in revised operation permits OP 87-07-91-0112 thru 0116, issued by IDEM on October 1, 1999. The revised limit for the #5 complex is contained in revised operation permit OP 87-07-91-0113 issued by IDEM on December 15, 1999.

The revised limits allow emissions with an opacity up to 80 percent during the fluxing portion of the production cycle from the East and West holding furnace exhaust stacks at the #1 Complex (HDC). This opacity is allowed for no more than 6 six-minute averaging periods, and only during fluxing. For all other portions of the production cycle, the limit remains at 40 percent. Fluxing typically lasts 12-15 minutes of the 5-10 hour production cycle for the HDC, but can last as long as 35 minutes.

For the East and West holding furnace exhaust stacks at the #8 Complex (EMC), the revised limit allows opacity during fluxing up to 85 percent for 2 six-minute averaging periods, and up to 80 percent opacity for 4 additional six-minute averaging periods. During all other portions of the production cycle, the opacity of emissions from the EMC continues to be limited to 40 percent. Fluxing typically lasts 12-15 minutes of the 3-4 hour production cycle for the EMC, but can last as long as 35 minutes.

For the East and West holding furnace exhaust stacks at the #5 Complex (HDC), the revised limit allows opacity during fluxing up to 80 percent for 3 six-minute averaging periods, 75 percent opacity for 1 six-minute averaging period, 65 percent opacity for 1 six-minute averaging period, and 55 percent opacity for 1 six-minute averaging period. During all other portions of the production cycle, the opacity of emissions from the EMC continues to be limited to 40 percent. Fluxing typically lasts 12-15 minutes of the 5-10 hour production cycle for the HDC, but can last as long as 35 minutes.

Mass PM emissions remain unchanged for all stacks at all complexes.

These processes are currently covered by SIP rule Title 326 Indiana Administrative Code, Article 5, Rule 1, Section 2 (326 IAC 5-1-2), which provides a 40 percent opacity limit (6-minute average).

They are also covered by a SIP mass emission limit contained in 326 IAC 6-3-2. This regulation provides for a limit based on the process rate, and continues to apply at all times.

Indiana provided stack test data and opacity readings. ALCOA conducted stack tests to show that the revised opacity limit would still be protective of the SIP mass PM emission limits. ALCOA conducted two rounds of stack tests on the #1 and #8 complexes, and one round on the #5 complex. ALCOA conducted opacity readings, utilizing EPA reference Method 9, during fluxing for many of the runs.

The first round of tests on the #1 and #8 complexes measured emissions of PM over the entire production cycle. (The production cycle lasts 5-10 hours for the HDC complexes (#1 and #5) and 3-4 hours for the EMC complex (#8).) Nine test runs were conducted on each exhaust stack. Fluxing was conducted for 35 minutes during each run, to approximate a worst-case scenario. (Fluxing normally lasts only 12-15 minutes.)

The second round of tests for the #1 and #8 complexes and the single round for the #5 complex were conducted for only one hour of the production cycle each, including the fluxing portion of the cycle. These tests were designed to show compliance with mass PM emissions limits on a one-hour basis. The tests include the fluxing portion of the cycle, since fluxing produces the bulk of emissions from the holding furnaces. 3-12 test runs were conducted on each exhaust stack. During these tests, fluxing was also conducted for a “worst-case” time of 35 minutes. ALCOA took opacity readings during the runs.

The tests show that ALCOA can meet SIP mass emissions limits at the EMC and HDC holding furnace stacks during fluxing. Even though opacity was often high during fluxing, no violations of the SIP mass PM emissions limits were measured. The tests indicate that the revised opacity limits should not result in violations of the mass limits for these sources.

The revised opacity limits will allow darker smoke to be emitted than does the current SIP rule. However, since no mass limits are being revised, and since the revised opacity limits are protective of the current mass limits, this SIP revision should not jeopardize air quality.

We are approving, through direct final rulemaking, revised opacity limits for three casting complexes at ALCOA Warrick Operations. We are publishing this action without prior proposal because we view this as a noncontroversial revision and anticipate no adverse comments. However, in a separate document in this Federal Register publication, we are proposing to approve the SIP revision should adverse written comments be filed. This action will be effective without further notice unless we receive relevant adverse written comment by August 4, 2000. Should we receive such comments, we will publish a final rule informing the public that this action will not take effect. Any parties interested in commenting on this action should do so at this time. If no such comments are received, you are advised that this action will be effective on September 5, 2000.

The Office of Management and Budget (OMB) has exempted this regulatory action from Executive Order 12866, entitled “Regulatory Planning and Review.”

Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), 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 rule is not subject to Executive Order 13045 because it does not involve decisions intended to mitigate environmental health or safety risks.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly affects or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments “to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.”

Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

Federalism (64 FR 43255, August 10, 1999) revokes and replaces Executive Orders 12612 (Federalism) and 12875 (Enhancing the Intergovernmental Partnership). 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.” Under Executive Order 13132, EPA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or EPA consults with State and local officials early in the process of developing the proposed regulation. EPA also may not issue a regulation that has federalism implications and that preempts State law unless the Agency consults with State and local officials early in the process of developing the proposed regulation.

This rule 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, because it merely approves a state rule implementing a federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental jurisdictions.

This rule will not have a significant impact on a substantial number of small entities because SIP approvals under section 110 and subchapter I, part D of the Clean Air Act do not create any new requirements but simply approve requirements that the State is already imposing. Therefore, because the Federal SIP approval does not create any new requirements, I certify that this action will not have a significant economic impact on a substantial number of small entities. Moreover, due to the nature of the Federal-State relationship under the Clean Air Act, preparation of flexibility analysis would constitute Federal inquiry into the economic reasonableness of state action. The Clean Air Act forbids EPA to base its actions concerning SIPs on such grounds. Union Electric Co. v. U.S. EPA , 427 U.S. 246, 255-66 (1976); 42 U.S.C. 7410(a)(2).

Under sections 202 of the Unfunded Mandates Reform Act of 1995 (“Unfunded Mandates Act”), signed into law on March 22, 1995, EPA must prepare a budgetary impact statement to accompany any proposed or final rule that includes a Federal mandate that may result in estimated costs to State, local, or tribal governments in the aggregate; or to the private sector, of $100 million or more. Under section 205, EPA must select the most cost-effective and least burdensome alternative that achieves the objectives of the rule and is consistent with statutory requirements. Section 203 requires EPA to establish a plan for informing and advising any small governments that may be significantly or uniquely impacted by the rule.

EPA has determined that the approval action promulgated does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or tribal governments in the aggregate, or to the private sector. This Federal action approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, result from this action.

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. Section 804, however, exempts from section 801 the following types of rules: Rules of particular applicability; rules relating to agency management or personnel; and rules of agency organization, procedure, or practice that do not substantially affect the rights or obligations of non-agency parties. 5 U.S.C. 804(3). EPA is not required to submit a rule report regarding this action under section 801 because this is a rule of particular applicability.

Section 12 of the National Technology Transfer and Advancement Act (NTTAA) of 1995 requires Federal agencies to evaluate existing technical standards when developing a new regulation. To comply with NTTAA, EPA must consider and use “voluntary consensus standards” (VCS) if available and applicable when developing programs and policies unless doing so would be inconsistent with applicable law or otherwise impractical.

The EPA believes that VCS are inapplicable to this action. Today's action does not require the public to perform activities conducive to the use of VCS.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 5, 2000. 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 affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-300983. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of (October 6, 1998, 63 FR 53656) (FRL-6033-8), EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 346a as amended by the FQPA of 1996 (Public Law 104-170) announcing the filing of a pesticide petition for tolerance by Rohm and Haas Company, 100 Independence Mall West, Philadelphia, PA 19106-2399. This notice included a summary of the petition prepared by Rohm and Haas Company, the registrant. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide, methoxyfenozide, in or on cottonseed; cotton gin trash; pome fruit; meat, kidney, meat byproducts and milk of cattle, goats, sheep and hogs and fat of cattle, goats, sheep and hogs at 2.0, 25.0, 1.25, 0.02, 0.1 parts per million (ppm) respectively and tolerances for the combined residues of methoxyfenozide and its glucuronide metabolite in or on liver of cattle, goats, sheep, and hogs at 0.1 ppm.

Methoxyfenozide is a reduced risk pesticide which will be sold under the trade name of Intrepid 2F. Methoxyfenozide controls codling moth, green fruitworm, lesser appleworm, Oriental fruit moth, obliquebanded leafroler, eyespotted bud moth, fruittree leafroller, pandemis leafroller, redbanded leafroller, variegated leafroller, tufted apple bud moth, spotted tentiform leafminer and Western tentiform leafminer on pome fruit and cotton bollworm, tobacco budworm, beet armyworm, cabbage looper, cotton leafworm, fall armyworm, Southern armyworm, soybean looper and true armyworm on cotton.

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for a tolerance for residues of methoxyfenozide on cotton, undelinted seed; cotton gin byproducts; pome fruit; apple pomace, wet; milk; meat of cattle, goats, hogs, horses, and sheep and fat of cattle, goats, hogs, horses, and sheep at 2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 ppm respectively, and tolerances for the combined residues of methoxyfenozide and its glucuronide metabolite in liver of cattle, goats, hogs, horses and sheep and meat byproducts (except liver) of cattle, goats, hogs, horses and sheep at 0.1 and 0.02 ppm respectively. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by methoxyfenozide are discussed in this unit.

Acute toxicity studies with technical grade: Oral LD 50 in the rat is > 5,000 milligrams/kilograms (mg/kg) for males and females-Toxicity Category IV; Oral LD 50 in the mouse is > 5,000 mg/kg for males and females-Toxicity Category IV; Dermal LD 50 in the rat is > 2,000 mg/kg-Toxicity Category III; Inhalation LC 50 in the rat is > 4.3 millgram/liter (mg/L)-Toxicity Category IV; Primary Eye Irritation in the rabbit -very mild irritant-Toxicity Category IV; Primary skin irritation in the rabbit-not a skin irritant-Toxicity Category IV. Methoxyfenozide is not a skin sensitizer.

In an acute neurotoxicity study in rats, statistically significant decreased hindlimb grip strength was observed in male rats at 3 hours (approximate time of peak effect) following a single oral dose of 2,000 mg/kg (limit dose) of methoxyfenozide. Decreased hindlimb grip strength was also observed in the male rats at 7 and 14 days, but was not statistically significant. No other systemic or neurotoxic effects were observed in the male rats or in the female rats at any time in this study. Since this marginal effect occurred only in one sex, was statistically significant at only one time, was observed only at the high dose (limit dose) and no other signs of toxicity were observed in the rats in this study, this possible effect is not considered to be biologically significant. In addition, neither decreased hindlimb grip strength nor any other signs of neurotoxicity were observed in any of the animals at any time in a 90-day subchronic neurotoxicity study in rats.

In a 2-week range-finding dietary study in rats, treatment-related effects were observed at > 5,000 ppm in the liver (increased liver weights and hepatocellular hypertrophy in males and females), in the thyroid gland (hypertrophy/hyperplasia of follicular cells in males and females), and in the adrenal gland (increased adrenal weights and/or hypertrophy of the zona fasciculata in females). Hypertrophy/hyperplasia of thyroid follicular cells was also observed in males and females at 1,000 ppm, the lowest observed adverse effect level (LOAEL) in this study. The no observed adverse effect level (NOAEL) was 250 ppm. Treatment-related hematological changes were not observed in the rats in this study.

In a 3-month feeding study in rats, the predominant treatment-related effects were increased liver weights in males and females and periportal hepatocellular hypertrophy in all males and females at 20,000 ppm highest dose tested (HDT) and at 5,000 ppm. In addition, at 20,000 ppm, a slightly decreased (7-8%) RBC count and slightly decreased (7-8%) hemoglobin concentration, compared to control rats, were observed in the females. The LOAEL in this study was 5,000 ppm (353/379 mg/kg/day in males/females, respectively). The NOAEL was 1,000 ppm (69/72 mg/kg/day in males/females, respectively). Although observed in the 2-week dietary study and in the 2-year chronic feeding/carcinogenicity study in rats, treatment-related effects in the thyroid and adrenal glands were not observed in the rats in this 3-month study. There is no available biological explanation for this difference in findings in the studies.

In a 2-year combined chronic feeding/carcinogenicity study in rats, the following treatment-related effects were observed at 20,000 ppm (highest dose tested): decreased survival in males, decreased body weight and food efficiency in females during the last year of the study, hematological changes (decreased RBC counts, hemoglobin concentrations, and/or hematocrits; methemoglobinemia; and increased platelet counts) in males and females, increased liver weights and periportal hepatocellular hypertrophy in males and females, thyroid follicular cell hypertrophy in males, altered thyroid colloid in males and females, and increased adrenal weights in males and females. At 8,000 ppm, the following treatment-related effects were observed: hematological changes (decreased RBC counts, hemoglobin concentrations, and/or hematocrits in males and females), liver toxicity (increased liver weights in males and periportal hepatocellular hypertrophy in males and females), histopathological changes in the thyroid (increased follicular cell hypertrophy in males and altered colloid in males) and possible adrenal toxicity (increased adrenal weights in males and females). The LOAEL in this study was 8,000 ppm (411/491 mg/kg/day in males/females, respectively), based on the effects described above. The NOAEL was 200 ppm (10.2/11.9 mg/kg/day in males/females, respectively). This NOAEL was used to establish the reference dose (RfD) for methoxyfenozide. Utilizing an uncertainty factor of 100 to account for both interspecies extrapolation (10x) and intraspecies variability (10x), the chronic RfD for methoxyfenozide was calculated to be 0.10 mg/kg/day. No evidence of carcinogenicity was observed in this study. Dosing was considered adequate because of the decreased survival in males and the decreased body weights and food efficiency in females at 20,000 ppm. In addition, the HDT for both males and females, 20,000 ppm (1,045/1,248 mg/kg/day in males/females, respectively), is higher than the limit dose of 1,000 mg/kg/day.

In a 2-week range-finding study in dogs, treatment-related hematological changes were observed in both males and females at 3,500 ppm, 7,000 ppm, 15,000 ppm, and 30,000 ppm (HDT). These changes included decreased RBC counts, decreased hemoglobin concentrations, decreased hematocrits, decreased MCHC, increased MCV, increased MCH, increased Heinz bodies, methemoglobinemia, changes in RBC morphology such as Howell-Jolly bodies and polychromasia, increased reticulocyte counts, increased nucleated RBC and increased platelet counts. At the same dose levels (> 3,500 ppm), increased spleen weights and/or enlarged spleens were also observed. At 7,000 ppm, plasma total bilirubin was increased. The LOAEL in this study was 3,500 ppm (90-184 mg/kg/day in males and females). The NOAEL was 300 ppm (11-16 mg/kg/day in males and females).

In a 3-month feeding study in dogs, no treatment-related effects other than a suggestion of decreased body weight gains in males and females were observed in either males or females at the HDT viz. 5,000 ppm (198/209 mg/kg/day in males/females, respectively). Although hematological effects were noted in dogs in the 2-week range-finding study at > 3,500 ppm (90-184 mg/kg/day) and in the 1-year chronic feeding study at > 3,000 ppm (106/111 mg/kg/day), hematological changes were not observed in this 3-month study at 5,000 ppm (198/209 mg/kg/day). There is no available biological explanation for this difference in findings in the studies.

As part of the 3-month study in dogs, some male and female dogs were given 15 ppm (0.6 mg/kg/day) of methoxyfenozide in the diet for 15 weeks followed by an increase in the dietary dose to 15,000 ppm (422/460 mg/kg/day in males/females, respectively) for an additional 6 weeks. After about 2 weeks and 6 weeks at 15,000 ppm, hematological examinations were conducted. No hematological changes in these dogs were observed. Apparently, pretreatment of the dogs at 15 ppm for 15 weeks prevented the occurrence of hematological changes which would have been expected to occur based on results in the 2-week and 1-year feeding studies. One possible explanation is that the liver microsomal enzyme system may have been stimulated so much during pretreatment at 15 ppm that the metabolic (detoxification) rate of methoxyfenozide was increased to the point where blood levels of methoxyfenozide may have remained below critical effect levels at 15,000 ppm. Another possible explanation is that compensatory mechanisms for replacing damaged RBC in pretreated dogs may have been so efficient that hematological changes were not observed in these dogs even at 15,000 ppm. Other explanations for this finding are also possible.

In a 1-year chronic feeding study in dogs, the predominant toxic effects were anemia and signs of an associated compensatory response. At 30,000 ppm, the HDT, the following treatment-related effects were observed in both males and females: decreased RBC counts, decreased hemoglobin concentrations, decreased hematocrits, methemoglobinemia, nucleated RBC, increased platelets, increased serum total bilirubin, bilirubinurea, increased hemosiderin in macrophages in liver and spleen, and increased hyperplasia in bone marrow of rib and sternum. Increased liver weights in males and females and increased thyroid weights in males were also observed at 30,000 ppm. Signs of anemia were also noted at 3,000 ppm and included decreased RBC counts, decreased hemoglobin concentrations, decreased hematocrits, methemoglobinemia, increased platelets, and increased serum total bilirubin and bilirubinurea. The LOAEL in this study was 3,000 ppm (106/111 mg/kg/day in males/females, respectively). The NOAEL was 300 ppm (9.8/12.6 mg/kg/day in males/females, respectively).

In a 3-month feeding study in mice, the only treatment-related effect was decreased body weight gain in males and females at 7,000 ppm, the HDT. The LOAEL in this study was 7,000 ppm (1,149/1,742 mg/kg/day in males/females, respectively) and the NOAEL was 2,500 ppm (428/589 mg/kg/day in males/females, respectively). In an 18-month carcinogenicity study in mice (MRID 44617729), no treatment-related effects were observed at doses up to and including the limit dose of 7,000 ppm (1,020/1,354 mg/kg/day in males/females, respectively). No evidence of carcinogenicity was observed in this study. Dosing was considered adequate because the HDT for both males and females, 7,000 ppm (1,020/1,354 mg/kg/day in males/females, respectively), is higher than the limit dose of 1,000 mg/kg/day.

In a battery of four mutagenicity studies (with and without metabolic activation, as appropriate for the specific study), technical grade methoxyfenozide was negative for genotoxicity in all four studies. The four studies satisfy the new revised mutagenicity guideline requirements for a new chemical (published in 1991). An additional mutagenicity study, performed on RH-117,236 (Metabolite M-B), a metabolite of methoxyfenozide, was also negative for genotoxicity.

Based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies, methoxyfenozide is classified as a “not likely” human carcinogen according to the EPA.

In a developmental toxicity study in rats, no signs of maternal toxicity in dams or of developmental toxicity in fetuses were observed at the limit dose of 1,000 mg/kg/day. The NOAEL in this study for both maternal toxicity and developmental toxicity was 1,000 mg/kg/day. The LOAEL was > 1,000 mg/kg/day. Similarly, in a developmental toxicity study in rabbits, no signs of maternal toxicity or of developmental toxicity were observed at the limit dose of 1,000 mg/kg/day. The NOAEL in this study for both maternal toxicity and developmental toxicity was 1,000 mg/kg/day. The LOAEL was > 1,000 mg/kg/day.

In neither the developmental toxicity study in rats nor in the developmental toxicity study in rabbits was there any evidence for increased susceptibility of fetuses to in utero exposure to methoxyfenozide. In these studies, methoxyfenozide was determined not to be a developmental toxicant.

In a 2-generation (1 litter/generation) reproduction study in rats, treatment-related parental toxicity was observed only at 20,000 ppm, the HDT. At this dose, increased liver weights were observed in males and females of both generations and midzonal to periportal hepatocellular hypertrophy was observed in the livers of all males and females of both generations. The LOAEL for parental toxicity was 20,000 ppm (1,552/1,821 mg/kg/day for males/females, respectively) and the NOAEL was 2,000 ppm (153/181 mg/kg/day for males/females, respectively). There were no treatment-related effects on reproductive parameters for adult (parent) animals. The NOAEL for reproductive toxicity was 20,000 ppm. Since no treatment-related effects were observed in the pups, the NOAEL for neonatal toxicity was also, 20,000 ppm. The NOAEL for parental toxicity in this reproduction study is higher than the NOAEL for the 2-year combined chronic feeding/carcinogenicity study in rats because many of the toxic effects observed in the 2-year study at the LOAEL (hematological changes, liver toxicity, histopathological changes in the thyroid gland and increased adrenal weights) were not examined in the reproduction study.

In a metabolism study in rats, 14 C-methoxyfenozide was rapidly absorbed, distributed, metabolized and almost completely excreted within 48 hours. The major route of excretion was feces (86-97%) with lesser amounts in the urine (5-13%). An enterohepatic circulation was observed. The test material was metabolized principally by O-demethylation of the A-ring methoxy group and oxidative hydroxylation of the B-ring methyl groups followed by conjugation with glucuronic acid. No significant sex-related or dose-dependent differences in metabolic disposition were noted. Seven metabolites and the parent accounted for 74-90% of the administered dose in all groups. The glucuronide conjugates are considered to be less toxic than the parent compound because glucuronide conjugation is well known to be a commonly occurring “detoxification” mechanism in mammalian species since it results in the formation of more polar, more water-soluble metabolites which are readily and easily excreted from the body (in this case, in the bile and urine). Further, based on similarities of chemical structure, the non-conjugated metabolites would be expected to be no more toxic than the parent compound. In a dermal absorption study in rats using an 80% wettable powder formulation as the test material, the cumulative dermal absorption of test material after a 10- or 24-hour dermal exposure was determined to be 2%. In a 28-day dermal toxicity study in rats, no treatment-related systemic or skin effects were observed at the limit dose of 1,000 mg/kg/day (HDT). Regarding effects on endocrine organs, methoxyfenozide affected the thyroid gland and adrenal gland in the 2-week and 2-year feeding studies in rats. In the thyroid gland, hypertrophy/hyperplasia of follicular cells and altered colloid were observed in males and females at or near the LOAEL in both of these studies. In the adrenal gland, increased adrenal weights and hypertrophy of the zona fasciculata were also observed in males and females at or near the LOAEL. In addition, in the 1-year chronic feeding study in dogs, increased thyroid weight in males was observed, but only at the very high dose of 30,000 ppm. Since the definition and regulatory significance of the term “endocrine disruptor chemical” has not yet been established by the Agency, it is not clear whether methoxyfenozide, on the basis of these effects on the thyroid gland and adrenal gland, should be considered to be an “endocrine disruptor chemical.” Other than the morphological changes described above, there were no signs of thyroid or adrenal dysfunction in these or in any other studies on methoxyfenozide.

1. Acute toxicity . No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on methoxyfenozide including the acute neurotoxicity study in rats, the developmental toxicity study in rats and the developmental toxicity study in rabbits. In the acute neurotoxicity study in rats, statistically significant decreased hindlimb grip strength was observed in male rats at 3 hours (approximate time of peak effect) following a single oral dose of 2,000 mg/kg (limit dose) of methoxyfenozide. Decreased hindlimb grip strength was also observed in the male rats at 2,000 mg/kg at 7 and 14 days, but was not statistically significant. Decreased hindlimb grip strength was not observed in the male rats at 1,000 mg/kg. No other systemic or neurotoxic effects were observed in the male rats or in the female rats at any time in the study. Since this marginal effect occurred only in one sex, was statistically significant only one time, was observed only at the high dose (limit dose) and no other signs of toxicity were observed in the rats in the study, this equivocal effect is not considered to be an appropriate toxicological endpoint for acute dietary risk assessments. In addition, decreased hindlimb grip strength was not observed in a subchronic neurotoxicity study in rats in any of the animals at any time. It is also noted that the acute oral LD 50 for male and female rats for technical grade methoxyfenozide (98% active ingredient (a.i.) is > 5,000 mg/kg (Toxicity Category IV). No treatment-related effects were observed in either dams or pups in the developmental toxicity studies in rats or rabbits at doses up to the limit dose of 1,000 mg/kg/day. Thus the risk from acute exposure is considered negligible.

2. Short- and intermediate-term toxicity . In a 28-day repeated dose dermal toxicity study in rats, no systemic or dermal toxicity was observed at 1,000 mg/kg/day, the HDT (limit dose). By applying the dermal absorption factor of 2% (derived from a dermal absorption study in rats, to the NOAEL of 10.2 mg/kg/day and the LOAEL of 411 mg/kg/day in the 2-year combined chronic feeding/carcinogenicity study in rats, the oral NOAEL and LOAEL in this study are equivalent to a dermal NOAEL of 510 mg/kg/day and a dermal LOAEL of 20,550 mg/kg/day. By applying the dermal absorption factor of 2% to the NOAEL of 9.8 mg/kg/day and the LOAEL of 106.1 mg/kg/day in the 1-year chronic feeding study in dogs, the oral NOAEL and LOAEL in this study are equivalent to a dermal NOAEL of 490 mg/kg/day and a dermal LOAEL of 5,305 mg/kg/day. The likelihood of toxic effects resulting from repeated dermal exposure to methoxyfenozide is quite low. Further, based on the use pattern, no long-term dermal exposure is expected to occur.

Methoxyfenozide is a non-volatile solid with a very low vapor pressure of > 1 x 10 -7 torr (or > 1.33 x 10 -5 pascal). In an acute inhalation toxicity study in rats, the acute inhalation LC 50 for technical grade methoxyfenozide dust (98% a.i.) was determined to be > 4.3 mg/L (> 2x limit dose, Toxicity Category IV) for both male and female rats. In another acute inhalation toxicity study in rats), the acute inhalation LC 50 for RH-112,485 80WP formulation 80% a.i. was determined to be > 4.5 mg/L (> 2x limit dose, Toxicity Category IV) for both male and female rats. In both of these acute inhalation toxicity studies, there were no mortalities, treatment-related clinical signs, changes in body weights or necropsy findings. Based on the low vapor pressure, the low acute inhalation toxicity (Toxicity Category IV) of the technical grade product and the formulated product, the packaging of the formulated product (water soluble pouches), the application rate (0.05 to 0.4 lb. a.i./acre for a maximum of 2.0 lb. ai/season), and the application method, there is minimal concern for potential inhalation risk. Further, based on the use pattern, no long-term inhalation exposure is expected to occur.

3. Chronic toxicity . EPA has established the RfD for methoxyfenozide at 0.10 mg/kg/day. This RfD is based on a NOAEL of 10.2 mg/kg/day and an UF of 100 accounting for both interspecies extrapolation (10x) and intraspecies variability (10x). This chronic RfD is based on the 2-year combined chronic feeding/carcinogenicity study in rats, in which the following effects were observed at the LOAEL of 411/491 mg/kg/day in males/females: hematological changes (decreased RBC counts, hemoglobin concentrations, and/or hematocrit in males and females), liver toxicity (increased liver weights in males and periportal hepatocellular hypertrophy in males and females), histopathological changes in the thyroid (increased follicular cell hypertrophy and altered colloid in males) and possible adrenal toxicity (increased adrenal weights in males and females). EPA determined that the 10x Safety Facter for the protection of infants and children (as required by FQPA) should be reduced to 1x. Therefore, the chronic Population Adjusted Dose (cPAD) is the same as the RFD. This cPAD is used in assessing chronic risk and applies to all population subgroups. Reducing the 10x safety factor to 1x is supported by the following factors:

i. The toxicology data base for methoxyfenozide is complete for assessment of potential hazard to infants and children.

ii. Based on weight-of-the-evidence considerations, EPA determined that a developmental neurotoxicity study in rats is not required to support the registration of methoxyfenozide.

iii. In developmental toxicity studies in rats and rabbits, no increased susceptibility in fetuses as compared to maternal animals was observed following in utero exposures.

iv. In a 2-generation reproduction study in rats, no increased susceptibility in pups as compared to adults was observed following in utero and postnatal exposures.

v. The exposure assessments will not underestimate the potential dietary (food and drinking water) or non-dietary exposures for infants and children from the use of methoxyfenozide.

4. Carcinogenicity . Methoxyfenozide has been classified as a “not likely” human carcinogen. This classification is based on the lack of evidence of carcinogenicity in male and female rats as well as in male and female mice and on the lack of genotoxicity in an acceptable battery of mutagenicity studies.

1. From food and feed uses . In today's action tolerances will be established (40 CFR part 180) for the residues of methoxyfenozide on cotton, undelinted seed; cotton gin byproducts; pome fruit; apple pomace, wet; milk; meat of cattle, goats, hogs, horses and sheep and fat of cattle, goats, hogs, horses and sheep at 2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 ppm and tolerances for the combined residues of methoxyfenozide and its glucuronide metabolite in liver of cattle, goats, hogs, horses and sheep and meat byproducts (except liver) of cattle, goats, hogs, horses and sheep at 0.1 and 0.02 ppm respectively. Risk assessments were conducted by EPA to assess dietary exposures from methoxyfenozide as follows.

i. Acute exposure and risk . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No appropriate toxicological endpoint attributable to a single exposure was identified in the available toxicology studies on methoxyfenozide including the acute neurotoxicity study in rats, the developmental toxicity study in rats and the developmental toxicity study in rabbits. This risk is considered to be negligible.

ii. Chronic exposure and risk . EPA used the Dietary Exposure Evaluation Model (DEEM ) software for conducting a chronic dietary (food) risk analysis. DEEM is a dietary exposure analysis system that is used to estimate exposure to a pesticide chemical in foods comprising the diets of the U.S. population, including population subgroups. DEEM contains food consumption data as reported by respondents in the USDA Continuing Surveys of Food Intake by Individuals conducted in 1989-1992. EPA has made the assumptions that 100% of pome fruit and cotton would be treated and contain methoxyfenozide residues at the tolerance level. The following tolerance levels were used in the analysis:

Processing factors were also applied to apple juice concentrate (3x), dried apples (8x), dried beef (1.92x), dried pears (6.25x), and dried veal (1.92x). The processing factors are default values from DEEM.

As shown in the following table, the resulting dietary food exposures occupy up to 11% of the Chronic PAD for the most highly exposed population subgroup, non-nursing infants. These results should be viewed as conservative (health protective) risk estimates. Refinements such as use of percent crop-treated information and/or anticipated residue values would yield even lower estimates of chronic dietary exposure.

2. From drinking water . The Agency currently lacks sufficient water-related exposure data from monitoring to complete a quantitative drinking water exposure analysis and risk assessment for methoxyfenozide. Therefore, the Agency is presently relying on computer-generated estimated environmental concentrations (EECs). GENEEC and/or PRZM/EXAMS (both produce estimates of pesticide concentration in a farm pond) are used to generate EECs for surface water and SCI-GROW (an empirical model based upon actual monitoring data collected for a number of pesticides that serve as benchmarks) predicts EECs in ground water. These models take into account the use patterns and the environmental profile of a pesticide, but do not include consideration of the impact that processing 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 assessing whether a pesticide is likely to be present in drinking water at concentrations which would exceed human health levels of concern.

A drinking water level of comparison (DWLOC) is the concentration of a pesticide in drinking water that would be acceptable as a theoretical upper limit in light of total aggregate exposure to that pesticide from food, water, and residential uses. HED uses DWLOCs internally in the risk assessment process as a surrogate measure of potential exposure associated with pesticide exposure through drinking water. In the absence of monitoring data for a pesticide, the DWLOC is used as a point of comparison against the conservative EECs provided by computer modeling (SCI-GROW, GENEEC, PRZM/EXAMS).

i. Acute exposure and risk . Because no acute dietary endpoint was determined, the Agency concludes that there is a reasonable certainty of no harm from acute exposure from drinking water.

ii. Chronic exposure and risk . EPA conducted its Tier II screening-level assessments using the simulation models SCI-GROW and PRZM/EXAMS to generate EECs for ground and surface water, respectively. The modeling was conducted based on the environmental profile and the maximum seasonal application rate proposed for methoxyfenozide (0.4 lb ai/acre x 5 applications/acre/year on cotton). PRZM/EXAMS was used to generate the surface water EECs, because it can factor the persistent nature of the chemical into the estimates.

The EECs for assessing chronic aggregate dietary risk are 312 parts per billion (ppb) (in ground water, based on SCI-GROW) and 3,197 ppb (in surface water, based on the PRZM/EXAMS, long-term mean). The back-calculated DWLOCs for assessing chronic aggregate dietary risk range from 890 ppb for the most highly exposed population subgroup (Non-nursing infants, > 1-year old) to 3,400 ppb for the U.S. population (48 contiguous States—all seasons) and the U.S. population (autumn season).

The SCI-GROW and PRZM/EXAMS chronic EECs are less than the Agency's level of comparison (the DWLOC value for each population subgroup) for methoxyfenozide residues in drinking water as a contribution to chronic aggregate exposure. EPA thus concludes with reasonable certainty that residues of methoxyfenozide in drinking water will not contribute significantly to the aggregate chronic human health risk and that the chronic aggregate exposure from methoxyfenozide residues in food and drinking water will not exceed the Agency's level of concern (100% of the cPAD) for chronic dietary aggregate exposure by any population subgroup. EPA generally has no concern for exposures below 100% of the cPAD, because it is a level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to the health and safety of any population subgroup. This risk assessment is considered high confidence, conservative, and very protective of human health.

3. From non-dietary exposure . Methoxyfenozide is not currently registered for use on any residential non-food sites. Therefore, there is no non-dietary acute, chronic, short- or intermediate-term exposure.

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

EPA does not have, at this time, available data to determine whether methoxyfenozide has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, methoxyfenozide 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 methoxyfenozide has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances November 26, 1997 (62 FR 62961) (5754-7).

1. Acute risk . Since no acute toxicological endpoints were established, EPA considers acute aggregate risk to be negligible.

2. Chronic risk . Using the DEEM exposure assumptions described in this unit, EPA has concluded that aggregate exposure to methoxyfenozide from food will utilize 1.8% of the cPAD for the U.S. population. The major identifiable subgroup with the highest aggregate exposure is non-nursing infants (> 1-year old) at 11% of the cPAD and is discussed below. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to methoxyfenozide in drinking water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD. EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to methoxyfenozide residues.

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

Since there are currently no registered indoor or outdoor residential non-dietary uses of methoxyfenozide and no short or intermediate term toxic endpoints, EPA considers short or intermediate term aggregate risks to be negligible.

4. Aggregate cancer risk for U.S. population . Methoxyfenozide is classified as a “not likely” human carcinogen. Therefore this risk does is negligible.

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

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

FFDCA section 408 provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a margin of exposure (MOE) analysis or through using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk to humans. EPA believes that reliable data support using the standard uncertainty factor (usually 100 for combined interspecies and intraspecies variability) and not the additional tenfold MOE/UF when EPA has a complete data base under existing guidelines and when the severity of the effect in infants or children or the potency or unusual toxic properties of a compound do not raise concerns regarding the adequacy of the standard MOE/safety factor.

2. Prenatal and postnatal sensitivity . The toxicology data base for methoxyfenozide included acceptable developmental toxicity studies in both rats and rabbits as well as a 2-generation reproductive toxicity study in rats.The data provided no indication of increased sensitivity of rats or rabbits to in utero and/or postnatal exposure to methoxyfenozide.

3. Conclusion . There is a complete toxicity data base for methoxyfenozide and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Based on the completeness of the data base and the lack of prenatal and postnatal toxicity, EPA determined that an additional safety factor was not needed for the protection of infants and children.

4. Acute risk . Since no acute toxicological endpoints were established, EPA considers acute aggregate risk to be negligible.

5. Chronic risk . Using the exposure assumptions described in this unit, EPA has concluded that aggregate exposure to methoxyfenozide from food will utilize 11% of the cPAD for infants and children. EPA generally has no concern for exposures below 100% of the cPAD because the cPAD represents the level at or below which daily aggregate dietary exposure over a lifetime will not pose appreciable risks to human health. Despite the potential for exposure to methoxyfenozide in drinking water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

6. Short- or intermediate-term risk . Short and intermediate term risks are judged to be negligible due to the lack of significant toxicological effects observed.

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

The qualitative nature of methoxyfenozide residues in plants is adequately understood based upon acceptable cotton, apple and grape metabolism studies. EPA has determined that the residue of concern for dietary exposure and tolerance setting purposes in primary crops and water is the parent compound, methoxyfenozide.

The qualitative nature of the residue in animals is adequately understood based on acceptable studies conducted on goats and laying hens. EPA has determined that the residue of concern in milk and ruminant tissues (other than liver and kidney) is the parent compound, methoxyfenozide. The residue of concern in ruminant liver and kidney is the parent compound, methoxyfenozide, and its glucuronide metabolite designated as RH-141,518 (also referred to as RH-1518). The glucuronide metabolite was included in the tolerance expression for liver and kidney because the conjugation may be reversible and it comprises a significant portion of the total radioactive residues (TRR) (up to 42% TRR in kidney and up to 29% TRR in liver) in those tissues.

The petitioner has proposed HPLC/UV Method TR 34-98-87 for the enforcement of tolerances for pome fruits. Adequate confirmatory method validation, radiovalidation, and independent method validation data have been submitted for this method. This method was sent to the EPA laboratory for a petition method validation (PMV). The laboratory has reported that the pome fruit method (Method TR 34-98-87) is adequate in the interim for enforcement of the proposed tolerances for methoxyfenozide in/on pome fruit. Initial recoveries (60%) in the PMV were just below the minium acceptable recovery level (70%) as specified in OPPTS Harmonized Test Guidelines 860.1340. The laboratory modified the method and achieved acceptable recoveries with the modified method. EPA will require that Rohm and Haas Company revise and modify the method. Additional recovery data will be required for the revised method.

The petitioner has proposed Method TR 43-96-88 for the enforcement of tolerances for cotton. This method is a shortened version of the pome fruit method. Thus, EPA concludes that Method TR 34-96-87 is adequate for enforcement of the proposed tolerances for residues of methoxyfenozide in/on cotton commodities. The validation of the cotton method is in progress. EPA expects that Method TR 43-96-88 will need to be modified or revised and additional recovery data may be required. EPA will require Rohm and Haas Company to revise and modify the cotton method and submit any additional recovery data if necessary.

The petitioner has proposed Method TR 34-98-106 for the enforcement of tolerances in animal commodities. This method determines residues of methoxyfenozide (HPLC/UV) in fat, cream, milk, and muscle and residues of methoxyfenozide and its glucuronide metabolite, RH-141,518 (HPLC/MS) in liver and kidney. Adequate confirmatory method validation, radiovalidation, and independent method validation data, have been submitted for this method. This method has been forwarded to the EPA laboratory for petition method validation (PMV). The method has passed the PMV, however it requires some minor revisions. EPA will require that Rohm and Haas Company revise the method and resubmit the final revised method.

The petitioner submitted data concerning the recovery of residues of methoxyfenozide using Food and Drug Administration (FDA) multiresidue method protocols (PAM Vol. I). Methoxyfenozide was not recoverable by these methods. These data will be forwarded to FDA for evaluation.

EPA has determined that the residues of concern in ruminant liver and kidney are methoxyfenozide and its metabolite RH-141,518. Data concerning the recovery of residues of RH-141,518 using FDA multiresidue method protocols (PAM Vol. I) will be required. This will be made a condition of the registration for methoxyfenozide.

Adequate enforcement methodology is available to enforce the tolerance expression. The methods may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460; telephone number: (703) 305-5229; e-mail address: furlow.calvin@epa.gov.

1. Magnitude of the residue in apples and pears . An adequate number of geographically representative field trials were submitted to support the proposed use on pome fruits. Apples and pears are the representative commodities of this crop group. These studies were conducted via use patterns approximating those proposed by this petition. Residues of methoxyfenozide ranged from 0.16 to 1.2 ppm in/on apples and from 0.21 to 0.93 ppm in/on pears treated with the 80% WP formulation according to the maximum proposed use patterns. The results of the field trials indicate that residues of methoxyfenozide will not exceed 1.5 ppm in/on pome fruit when treated as proposed. Rohm and Haas Company proposed a tolerance level of 1.25 ppm for residues of methoxyfenozide in/on pome fruit. EPA concludes that the proposed tolerance must be raised to 1.5 ppm for methoxyfenozide in/on the “Crop Group 11; Pome Fruits Group.”

2. Magnitude of the residue in cotton . An adequate number of geographically representative field trials were submitted to support the proposed use on cotton. These studies were conducted via use patterns approximating those proposed by this petition. The results of the cotton field trials indicate that residues of methoxyfenozide will not exceed the proposed tolerance level of 2.0 ppm in/on cottonseed when treated as proposed. Residues of methoxyfenozide ranged from 0.060 to 1.8 ppm in/on cottonseed treated with the 80% WP formulation according to the maximum proposed use pattern. Residues of methoxyfenozide did not vary significantly in cotton treated with ULV spray applications (1 GPA) versus standard volume applications (10-30 GPA). Residues ranged from 0.13 to 0.32 ppm and from 0.12 to 0.66 ppm in/on cotton treated in side-by-side plots with ULV and standard volume applications, respectively. Rohm and Haas Company requested the proposed tolerance on cottonseed at 2.0 ppm. However, EPA has determined that it should be “cotton, undelinted seed” at 2.0 ppm.

The results of the cotton field trials indicate that residues of methoxyfenozide may exceed the proposed tolerance level of 25 ppm in/on cotton gin byproducts when treated as proposed. Residues of methoxyfenozide ranged from 3.8 to 31.2 ppm in/on cotton gin byproducts treated with the 80% WP formulation according to the maximum proposed use pattern. Based on these data, the tolerance for residues of methoxyfenozide in/on cotton gin byproducts must be raised to 35 ppm.

3. Magnitude of the residue in apple processed commodities . The submitted apple processing data are adequate for the purposes of this petition. Residues of methoxyfenozide did not concentrate in juice but concentrated 6x in wet pomace processed from whole apples bearing detectable residues. Based on the results of the apple processing study, a tolerance for residues of methoxyfenozide in apple juice is not required. Rohm and Haas proposed a tolerance level of 7.5 ppm for residues of methoxyfenozide in/on apple wet pomace. The maximum residue level of methoxyfenozide expected in apple wet pomace was 6.06 ppm, calculated by multiplying the HAFT residue (1.01 ppm; see apple field trial) and the observed concentration factor (6x). Based on this calculation, a tolerance of 7.0 ppm for residues of methoxyfenozide in/on “apple pomace, wet” is appropriate.

4. Magnitude of the residue in cottonseed processed commodities . The submitted cotton processing data are adequate for the purposes of this petition. No concentration of methoxyfenozide residues was observed in hulls, meal, and oil processed from undelinted cottonseed bearing detectable residues. Based on the results of the current processing study, tolerances for residues of methoxyfenozide in the processed commodities of cotton are not required.

5. Residues in meat, milk, poultry, and eggs . The submitted dairy cattle feeding study is adequate for the purpose of establishing tolerances for secondary transfer of methoxyfenozide residues in milk and ruminant tissues. EPA has determined that the residues of concern in milk and ruminant tissues (except kidney and liver) are the parent compound, methoxyfenozide. For liver and kidney, the residues of concern are the parent compound, methoxyfenozide, and its metabolite RH-141,518. EPA concludes that residues of methoxyfenozide are not likely to exceed the proposed tolerances of 0.02 ppm in the milk and meat of cattle, goats, hogs, horses, and sheep. EPA further concludes that residues of methoxyfenozide are not likely to exceed the proposed tolerance of 0.1 ppm in the fat of cattle, goats, hogs, horses, and sheep as a result of the proposed uses. EPA also concludes that residues of methoxyfenozide and its metabolite RH—141,518 are not likely to exceed 0.1 ppm in liver and 0.02 ppm in meat byproduct (except liver) of cattle, goat, hogs, horses, and sheep. The proposed tolerances did not include residues in tissues of horses. However, horses must be a part of the tolerance.

Rohm and Haas Company requested a waiver from the requirements to: (i) Conduct a poultry feeding study; (ii) propose tolerances for methoxyfenozide residues of concern in eggs and poultry tissues; and (iii) provide enforcement method(s) for determination of methoxyfenozide residues of concern in eggs and poultry tissues. The waiver request is based on the maximum theoretical dietary burden of methoxyfenozide for poultry animals as well as the results of the poultry metabolism study. The only poultry feed item associated with this petition is cotton meal, which would contribute a maximum theoretical dietary burden for methoxyfenozide at 0.4 ppm.

The poultry metabolism study reviewed in this petition was conducted at feeding levels of 58 ppm (MOP-label), 60 ppm (DMP-label), and 68 ppm (TB-label) which are equivalent to 145x, 150x, and 170x, respectively, the maximum theoretical dietary burden for poultry. Assuming a linear relationship between dose and residues, the expected residues in eggs and poultry tissues would be below the LOD for methods used to measure residues in poultry products. EPA concludes that there is no reasonable expectation of finite residues in eggs and poultry tissues and that a poultry feeding study is not required at this time. However, should the dietary burden for poultry increase due to the addition of methoxyfenozide-treated poultry feed items through new uses, a poultry feeding study may be required. If a poultry feeding study is required in the future, then all tissues should be analyzed for residues of methoxyfenozide and its metabolite RH-141,518.

There are no established or proposed Codex, Canadian or Mexican limits for residues of methoxyfenozide in/on plant or animal commodities. Therefore, no compatibility issues exist with regard to the proposed U.S. tolerances discussed in this petition review.

A confined rotational crop study was submitted and reviewed. The petitioner has proposed a 30-day plantback interval for all crops not listed on the product label. The confined rotational crop study demonstrated that methoxyfenozide may accumulate in rotational crop commodities at > 0.01 ppm at 30- and 90-day plantback intervals. The rotational crop restrictions included on the submitted label are not adequate. The label must include the following rotational crop restrictions: Cotton may be rotated to treated fields at any time. Leafy vegetables (except Brassica vegetables) and root and tuber vegetables may be rotated to treated fields 1-year following application of methoxyfenozide. Rotation to all other crops is prohibited.

Therefore, the tolerances are established for residues of methoxyfenozide in or on cotton, undelinted seed; cotton gin byproducts; pome fruit; apple pomace, wet; milk; meat of cattle, goats, hogs, horses and sheep and fat of cattle, goats, hogs, horses and sheep at 2.0, 35.0, 1.5, 7.0, 0.02, 0.02, 0.1 ppm respectively and for the combined residues of methoxyfenozide and its glucuronide metabolite in liver of cattle, goats, hogs, horses and sheep and meat byproducts (except liver) of cattle, goats, hogs, horses and sheep at 0.1 and 0.02 ppm respectively.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-300983 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 September 5, 2000.

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

Mail your written request to: Office of the Hearing Clerk (1900), Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. M3708, Waterside Mall, 401 M St., SW., Washington, DC 20460. The Office of the Hearing Clerk is open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is (202) 260-4865.

2. Tolerance fee payment . If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or request a waiver of that fee pursuant to 40 CFR 180.33(m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission 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, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460.

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

3. Copies for the docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-300983, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

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

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

1. Electronically . You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations” and then look up the entry for this document under the “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person . The Agency has established an official record for this action under docket control number OPP-300997. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2 (CM #2), 1921 Jefferson Davis Hwy., Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

In the Federal Register of April 26, 1999 (64 FR 20295) (FRL-6074-8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a(e), as amended by FQPA (Public Law 104-170) announcing the filing of a pesticide tolerance petition by AgraQuest, Inc., 1530 Drew Ave., Davis California 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 an exemption from the requirement of a tolerance for residues of Bacillus subtilis strain QST 713.

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

A battery of tests determined that QST 713 Technical product is not pathogenic and has no significant toxicity. The acute oral toxicity/pathogenicity, acute pulmonary toxicity/pathogenicity and acute intravenous toxicity/pathogenicity studies demonstrated no significant toxicity and a lack of pathogenicity. The dermal toxicity and eye irritation studies resulted in a Toxicity Category III classification. The acute dermal irritation study resulted in a Toxicity Category IV classification. Bacillus subtilis strain QST 713 is a ubiquitous organism in the environment and there have been no reports of the organism affecting the immune system. The submitted toxicity/pathogenicity studies in rodents with Bacillus subtilis strain QST 713 indicated that following several routes of exposure, the immune system is still intact and able to process and clear the active ingredient. As would be expected for any microbial pesticide, QST 713 did elicit a very mild delayed hypersensitivity response and is considered a potential dermal sensitizer. Further, although it is not known whether strain QST 713 does, the species is known to produce the enzyme subtilisin which has been reported to produce allergenic or hypersensitivity reactions to individuals repeatedly exposed to the enzyme in industrial settings. The use of personal protective equipment required for applicators and other handlers mitigates the hypersensitivity risk by minimizing exposure. No hypersensitivity risk is expected for dietary exposure due to the low likelihood that any significant residues will occur on treated food.

In examining aggregate exposure, FFDCA section 408 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).

Dietary exposure to the microbial pesticide is likely to occur. The lack of acute oral toxicity/pathogenicity, and the ubiquitous nature of the microbial, support the establishment of an exemption from the requirement of a tolerance for Bacillus subtilis strain QST 713.

1. Food . Dietary exposure to the microbial is expected to be minimal. In additon, standard practices of washing, peeling, cooking, or processing fruits and vegetables will reduce residues of Bacillus subtilis strain QST 713 and further minimize dietary exposure. The risk posed to adults, infants, and children is likely to be minimal, because of the low acute oral toxicity/pathogenicity potential of the microbial pesticide.

2. Drinking water exposure . Oral exposure, at very low levels, may occur from ingestion of drinking water. Drinking water is not being screened for Bacillus subtilis strain QST 713 as a potential indicator of microbial contamination. Both percolation through soil and municipal treatment of drinking water would reduce the possibility of exposure to the bacterial active ingredient through drinking water. If oral exposure should occur through drinking water, the Agency concludes that such exposure would present minimal risk due to the lack of acute oral toxicity/pathogenicity and the ubiquitous nature of the microbe.

The use sites proposed are for agricultural sites. Dermal and inhalation exposure is expected to be limited to those who apply or handle the pesticide in orchards and farms. Bacillus subtilis presence is ubiquitous in the environment and the use of this product is not expected to increase dermal or inhalation exposure in non-occupational settings.

No mechanism of toxicity in mammals has been identified for Bacillus subtilis strain QST 713. Therefore no cumulative effect with other related organisms is anticipated. Because the data available demonstrate a low toxicity/pathogenicity potential of the active ingredient, the likelihood of adverse dietary effects is expected to be minimal.

Based on the acute toxicity information discussed above, EPA concludes that there is a reasonable certainty that no harm will result from aggregate exposure to the United States population, including infants and children, to residues of Bacillus subtilis strain QST 713. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because, the data available on Bacillus subtilis strain QST 713 demonstrate a low toxicity/pathogenicity potential. Bacillus subtilis is not a human pathogen and has not been implicated in human disease, but has been isolated as a rare contaminant from human infections. Risk of increased exposure is likely only to exist for pesticide applicators and manufacturers of the product. The Agency has imposed appropriate risk mitigation measures to protect the workers via the use of protective clothing.

The Agency has no information to suggest that Bacillus subtilis strain QST 713 has an effect on the immune and endocrine systems. No specific tests have been conducted with Bacillus subtilis strain QST 713 to determine such effects. However, 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. Bacillus subtilis strain QST 713 is a ubiquitous organism in the environment and there have been no reports of the organism affecting endocrine system. Therefore, it is unlikely that this organism would have estrogenic or endocrine effects because it is practically non-toxic to mammals.

The Agency proposes to establish an exemption from the requirement of a tolerance without any numerical limitation; therefore the Agency has concluded that an analytical method is not required for enforcement purposes for Bacillus subtilis strain QST 713.

There are no CODEX values for Bacillus subtilis strain QST 713.

Under section 408(g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408(g) provides essentially the same process for persons to “object” to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408(d), as was provided in the old FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-300997 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 September 5, 2000.

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

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

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

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

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

3. Copies for the Docket . In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit IX.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket number OPP-300997, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

EPA Region 5 announces the deletion of the Laskin/Poplar Oil Company Site from the National Priorities List (NPL), appendix B of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300. U.S. EPA identifies sites that appear to present a significant risk to public health, welfare and the environment, and maintains the NPL as the list of those sites. Sites on the NPL may be the subject of remedial actions that the Hazardous Substance Superfund Response Trust Fund (Fund) finances. Under § 300.425(e) (3) of the NCP, any site deleted from the NPL remains eligible for Fund-financed remedial actions if the conditions at the site warrant such action.

EPA will accept comments on this proposal for thirty (30) days after publication of this document in the Federal Register .

Section II of this action explains the criteria for deleting sites from the NPL. Section III discusses procedures that U.S. EPA is using for this action. Section IV discusses the history of this site and explains how the site meets the deletion criteria. Section V states U.S. EPA's prospective action of deleting the Site from the NPL unless dissenting comments are received during the comment period.

Deletion of sites from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Specifically, this deletion does not affect the provisions or requirements of the Consent Decrees entered in United States v. Alvia Laskin, et al Civil Action (84-2035Y N.D. Ohio) and United States v. Anchor Motor Freight Co., et al, Civil Action No. (89CV1999 N. D. Ohio. Furthermore, deletion from the NPL does not in any way alter U.S. EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist in Agency Management.

Section 300.425(e) of the NCP provides that Sites may be deleted from, or recategorized on, the NPL where no further response is appropriate. In making a determination to delete a release from the NPL, EPA shall consider, in consultation with the state, whether any of the following criteria have been met:

(i) Responsible parties or other persons have implemented all appropriate response actions required; or

(ii) All appropriate non-time critical Removal Actions or Fund-financed responses under CERCLA have been implemented, and no further response action by responsible parties is appropriate; or

(iii) The Remedial Investigation has shown that the release poses no significant threat to public health or the environment and, therefore, remedial measures are not appropriate. The Laskin/Poplar Oil Site now meets criterion (i). Criteria (ii) and (iii) are not relevant to this Site.

The following procedures were followed before the proposed deletion of this Site from the NPL:

(1) All appropriate response actions, under CERCLA have been implemented and no further EPA action is appropriate; (2) The State of Ohio has concurred with the proposed deletion decision; (3) A notice has been published in the local newspaper and has been distributed to appropriate federal, state, and local officials and other interested parties announcing the commencement of a 30-day dissenting public comment period on U.S. EPA's Direct Final Action to Delete; and, (4) All relevant documents have been made available for public review in the local Site information repositories. EPA is requesting only dissenting comments on the Direct Final Action to Delete.

For deletion on the Site, EPA's Regional Office will accept and evaluate public comments on U.S. EPA's Final Notice. If necessary, the Agency will prepare a Responsiveness Summary, responding to each significant comment submitted during the public comment period. As stated in section I above, deletion of the Site from the NPL does not itself create, alter, or revoke any individual's rights of obligations. The NPL is designed primarily for informational purposes and to assist Agency management. Further, mentioned in section II of this document, § 300.425(e)(3) of the NCP states that the deletion of a release from a site from the NPL does not preclude the Site's eligibility for future response actions.

The Laskin/Poplar Oil Company Site is located at 717 North Poplar Street in Ashtabula County, Jefferson Township, Ohio west of the Village of Jefferson. The nine-acre site is bounded on the north by Cemetery Creek, on the south by Ashtabula County Fairground, to the east by Poplar Street, and to the west by softball fields and a wooded ravine belonging to the County of Ashtabula.

Prior to remedial action implementation the Site contained the property owner's former residence, a greenhouse complex, a boiler house containing 4 boilers formerly used to heat the greenhouses, a smokestack, 4 in-ground oil storage pits, 1 underground and 32 above ground tanks, a retention pond, two drained ponds, a fresh water pond, and miscellaneous buildings and sheds.

Greenhouses were located on the Site since the early 1890's. In the 1950's, boilers were installed to heat the greenhouse. Storage pits and tanks were installed during the 1960's to store the oil that fired the boilers. The Poplar Oil Company continued to accept waste oil from hundreds of sources in northern Ohio and western Pennsylvania throughout the 1960's and 1970's. The company resold some of the waste oil and used additional waste oil to treat gravel and dirt roads in 17 townships of Ashtabula County. In 1977, U.S. EPA and Ohio Environmental Protection Agency (OEPA) indentified polychlorinated biphenys (PCBs) in the waste oil. In 1981, a court order stopped activities at the Poplar Oil Company.

In early 1981, EPA investigated the Site and detected PCBs in waste oils, ground water and soils. In 1981 and 1982, EPA performed several removal actions at the Site. The emergency actions included draining and regrading two ponds; diverting surface runoff to a retention pond to prevent flooding; removing 302,000 gallons of waste oil taking them to an off-site incinerator; treating and discharging off site 430,000 gallons of contaminated surface water; and solidifying on site 205,000 gallons of sludge.

In 1983, the Site was placed on the EPA's Superfund National Priorities List of uncontrolled hazardous waste sites. Fund-lead Phase I remedial investigation (RI) activities were conducted from December 1983 to November 1984. In response to an Administrative Order issued in August 1984, the potentially responsible parties(PRPs) removed approximately 250,000 gallons of waste oil and wastewater during the winter of 1985-1986. A second Administrative Order was issued to the PRPs in late 1986, which ordered them to develop a work plan to address the storage pits, tank, and their contents, and surrounding soils. EPA completed Focused Feasibility Study (FFS) in August 1987. The Source Removal (SR) Record of Decision (ROD) was issued on September 30, 1987. Phase II RI activities were conducted in the fall and winter of 1987-88. A third Administrative Order was issued in February 1988 for implementing the 1987 SR ROD. The Phase II RI Report which contained the results of both the Phase I and II RI Investigations was released in December 1988. The Final Remedy (FR) FS was provided for public comment on April 7, 1989. A final remedy was selected on June 29, 1989 and documented in the FR ROD.

PRPs organized the Laskin Site Group and performed the SR and the FR remedial design and remedial actions (RD/RA) under a September 1990 Consent Decree. The SR ROD work to be performed under the 1988 Administrative Order was incorporated into the 1990 Consent Decree. Due to the incineration of different materials set forth in both RODs and the need to prepare the Site for RA activities, some FR activities were necessarily performed during the SR.

The SR ROD selected remedy consists of the following major components:

• Construction of a fence around the contaminated portions of the Site and the mobile on-site incinerator;

• Off-site treatment of all wastewater, decontamination water, and scrubber water;

• Dismantling and off-site disposal of all tanks;

• Crushing and incineration of the cinder block walls of the pits; and

• Backfilling and/or grading of all excavated areas to prevent ponding.

The components of the FR ROD consist of the following:

• Drain retention and fresh water ponds. Discharge surface water from ponds to Cemetery Creek, with treatment if required. Backfill a freshwater pond with clean fill and grade retention pond area;

• Thermally treat contaminated soil, ash, and debris from the boiler house area and dispose of ash on-site (if delistable) or off-site to a RCRA permitted landfill;

• Demolish and thermal treatment or decontamination of dioxin contaminated structures. If material cannot be thermally treated or decontaminate, contain material in an on-site concrete vault and place beneath the cap;

• Construct a groundwater diversion trench up-gradient of the contaminated oil and groundwater;

• Construct a multi-layer cap;

• De-water site by natural groundwater flow to Cemetery Creek;

• Conduct groundwater and surface water monitoring to assess quality of groundwater migrating towards Cemetery Creek; and

• Impose access and use restrictions.

The ROD and statement of work for the Consent Decree included performance standards for the FR including:

1. The on-site incinerator would meet a destruction and removal efficiency at 99.99% for solvents, miscellaneous organics, 99.999% dioxin and 99.999% for PCBS;

2. Discharges to the water in Cemetery Creek must comply with Ohio Water Quality Standards, and Federal Ambient Water Quality Criteria;

3. The goal of the groundwater diversion was to dewater the site. If the groundwater is lowered to below the top of the unweathered shale, the site would be considered dewatered. If complete site dewatering was not achieved then Federal Maximum Contaminant Levels, under the Safe Drinking Water Act, would apply at the property boundary.

In June 1991, the Remedial Design (RD) for the SR was finalized, and in the Remedial Action (RA) work was formally initiated. U.S. EPA and Ohio Environmental Protection Agency (OEPA) conducted a prefinal inspection on November 19, 1992. Incineration of all required material was completed on November 25, 1992. EPA approved the RA report on December 22, 1992.

The FR RD was formally approved and the RA work initiated in March 1992. The FR included construction of a slurry wall to facilitate site dewatering in addition to the diversion trenches provided for in the ROD. A letter dated September 21, 1993 from the PRP Laskin/Poplar Site Group certified that all RA activities were performed according to design specifications, contractor plan, and EPA and OEPA approved modifications. EPA conducted a final inspection on September 20, 1993, and approved a Preliminary Close Out Report on September 23, 1993.

Since completion of construction, the Site has been monitored and inspected in accordance with a EPA approved Inspection, Maintenance and Monitoring Plan. In accordance with this plan, quarterly groundwater and surface water monitoring was conducted in 1994, 1995, and 1996, and semi-annual groundwater and surface water monitoring was conducted in 1997 and 1998.

A five-year review pursuant to OSWER Directive 9355.7-02 (“Structure and Components of Five-Year Reviews”) was conducted at the Site and a report of its conclusions was signed in May 1999. The five-year review report concluded that the remedial action selected for this Site remains protective of human health and the environment. The review determined that groundwater monitoring conducted over the five years since completion of construction has demonstrated that the groundwater has consistently been lowered below the unweathered shale, and that the data has not identified an impact of the Site on groundwater of surface water.

In its review of the five year review report, Engineering Management Inc., the Laskin Remedial Trust Fund's contractor correctly pointed out that the non-incinerable materials that were potentially dioxin-contaminated were decontaminated sampled, and found to contain less the 1 ppb of dioxin. As a result, it was not necessary to store any dioxin-contaminated material in a proposed vault below the cap, and this part of the remedy was eliminated. A small amount of asbestos-contaminated material was encased in what has been referred to as a “concrete vault” on site diagrams, but this vault is not the vault referred to in the ROD. The five year review found that the Site inspections have indentified a concern about slope stability, as well as routine erosion problems. The on-going inspection and maintenance program will address these problems. The next five year review should be completed by October 15, 2000.

On June 30, 1999, EPA approved discontinuing the periodic groundwater and surface water sampling. However, periodic water level monitoring, inspections, and maintenance activities will continue, and groundwater and surface water sampling can resume if necessary.

EPA, will the State of Ohio's concurrence, has determined that all appropriate Fund-financed responses under CERCLA at the Ladkin-Poplar Oil Company Superfund Site have been completed, and no further CERCLA response is appropriate or necessary in order to provide protection of human health and the environment other than the ongoing inspection, maintenance and monitoring activities. Therefore, EPA is deleting the Site from the NPL.

This action will be effective September 5, 2000. However, if EPA receives dissenting comments by August 4, 2000, EPA will publish a document that withdraws this action.

You may be affected by this action if you manufacture (defined by statute to include import) any of the chemical substances that are listed in § 712.30(e) of the regulatory text portion of this document. Entities potentially affected by this action may include, but are not limited to:

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

1. Electronically . You may obtain electronic copies of this document and other documents from the EPA Internet EPA Home Page at http://www.epa.gov/. On the Home Page select “Law and Regulations” and then look up the entry for this document under “ Federal Register —Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/.

2. In person. The Agency has established an official record for this action under docket control number OPPTS-82054. The official record consists of the documents specifically referenced in this action, any public comments received during an applicable comment period, and other information related to this action, including any information claimed as Confidential Business Information (CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period, is available for inspection in the TSCA Nonconfidential Information Center, North East Mall Rm. B-607, Waterside Mall, 401 M St., SW., Washington, DC. The Center is open from noon to 4 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Center is (202) 260-7099.

You may submit comments through the mail, in person, or electronically. To ensure proper receipt by EPA, your comments must identify docket control number OPPTS-82054 in the subject line on the first page of your response.

1. By mail . Submit comments to: Document Control Office (7407), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

2. In person or by courier . Deliver comments to: Document Control Office, Office of Pollution Prevention and Toxics, Environmental Protection Agency, 401 M St., SW., East Tower, Rm. G-099, Washington, DC. The telephone number for the OPPT Document Control Office is (202) 260-7093.

3. Electronically . Submit your comments electronically by e-mail to: oppt.ncic@epa.gov, or you may mail or deliver your computer disk to the addresses identified in Units I.C.1. or 2. Do not submit any information electronically that you consider to be CBI. Submit comments as an ASCII file, avoiding the use of special characters and any form of encryption. Comments will also be accepted on standard disks in WordPerfect 6.1/8 or ASCII file format. All copies of electronic comments must be identified by docket control number OPPTS-82054. Electronic comments may be filed online at many Federal Depository Libraries.

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit in response to this document as CBI 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. In addition to one complete version of the comments that include any information claimed as CBI, a copy of the comments that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, consult the technical person listed under “FOR FURTHER INFORMATION CONTACT.”

In this document, EPA is issuing a final TSCA section 8(a) “Preliminary Assessment Information Reporting” (PAIR) rule for 29 alkylphenols, alkylphenol ethoxylates, and polyalkylphenols recommended for testing in the 41st TSCA ITC Report to the EPA Administrator published in the Federal Register of April 9, 1998 (63 FR 17658) (FRL-5773-5).

EPA promulgated the PAIR rule in 40 CFR part 712 under section 8(a) of TSCA (15 U.S.C. 2607(a)). This model section 8(a) rule establishes standard reporting requirements for manufacturers (including importers) of the chemicals listed in the rule at 40 CFR 712.30. These entities are required to submit a one-time report on general production/importation volume, end use, and exposure-related information using the Preliminary Assessment Information Manufacturer's Report (EPA Form No. 7710-35). EPA uses this model section 8(a) rule to quickly gather current information on chemicals.

This model rule provides for the automatic addition of ITC Priority Testing List chemicals. Whenever EPA announces the receipt of an ITC Report, EPA may, at the same time and without providing notice and opportunity for public comment, amend the model information-gathering rule by adding the recommended (or designated) chemicals. The amendment adding these chemicals to the PAIR rule is effective August 4, 2000.

In its 41st Report to EPA, the ITC recommended 29 alkylphenols, alkylphenol ethoxylates, and polyalkylphenols. These chemicals can be automatically added to the TSCA section 8(a) PAIR reporting rule.

The regulatory text (§ 712.30(e)) of this document lists the 29 alkylphenols, alkylphenol ethoxylates, and polyalkylphenols that are being added to the PAIR rule as a result of this document.

All persons who manufactured (defined by statute to include import) the 29 alkylphenols, alkylphenol ethoxylates, and polyalkylphenols identified in the regulatory text (§ 712.30(e)) of this rule during their latest complete corporate fiscal year must submit a Preliminary Assessment Information Manufacturer's Report (EPA Form No. 7710-35) for each site at which they manufactured or imported a named substance. A separate form must be completed for each substance and submitted to the Agency as specified in 40 CFR 712.28 no later than October 3, 2000. Persons who have previously and voluntarily submitted a Manufacturer's Report to the ITC or EPA may be able to submit a copy of the original report to EPA or to notify EPA by letter of their desire to have this voluntary submission accepted in lieu of a current data submission. See § 712.30(a)(3).

Details of the PAIR reporting requirements, including the basis for exemptions, are provided in 40 CFR part 712. Copies of the form are available from the TSCA Environmental Assistance Division at the address listed under FOR FURTHER INFORMATION CONTACT . Copies of the PAIR form are also available electronically from the Chemical Testing and Information Gathering Home Page on the Internet at http://www.epa.gov/opptintr/chemtest/.

Any person who believes that section 8(a) reporting required by this rule is not warranted, should promptly submit to EPA on or before July 19, 2000, detailed reasons for that belief. EPA, in its discretion, may remove the substance from this rule (see 40 CFR 712.30(c)). When withdrawing a chemical from the rule, EPA will publish a rule amendment in the Federal Register .

The following documents constitute the public record for this rule under docket control number OPPTS-82054.

1. This final rule.

2. The Economic Analysis for this rule (February 10, 2000).

3. The 41st Report of the ITC (63 FR 17658, April 9, 1998) (FRL-5773-5).

EPA is publishing this action as a final rule without prior notice and an opportunity to comment because the Agency believes that providing notice and an opportunity to comment is unnecessary. As discussed in Unit III., whenever EPA announces the receipt of an ITC report, EPA may, at the same time and without providing notice and opportunity for public comment, amend the model information-gathering rule by adding the recommended (or designated) chemicals. EPA finds, therefore, that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5 U.S.C. 553 (b)(3)(B)) to make these amendments without prior notice and comment.

The economic analysis for the addition of the 29 alkylphenols, alkylphenol ethoxylates, and polyalkylphenols to the TSCA section 8(a) PAIR rule is entitled “ Economic Analysis for the Addition of 29 Chemicals Recommended for Testing in the 41st Report of the TSCA Interagency Testing Committee to EPA's Preliminary Assessment Information Reporting (PAIR) Rule” (February 10, 2000) (Economic Analysis).

EPA's 1998 Chemical Update System (CUS) was searched to identify manufacturers (including importers) of the 29 CAS-numbered alkylphenols, alkylphenol ethoxylates, and polyalkylphenols recommended in the ITC's 41st Report. Only 5 of the 29 chemicals were located in CUS indicating, for example, that the other chemicals are not being produced or imported in quantities large enough to be reported to EPA for 1998 under the TSCA Inventory Update Rule (IUR) (40 CFR part 710) or are not subject to reporting under the IUR. The Economic Analysis estimates governmental and industry burden and costs associated with this final rule based upon the data regarding the five chemical substances found in CUS. Six firms were identified as manufacturers of the chemical, at eight sites. The costs and burden associated with this rule are estimated in the Economic Analysis to be the following:

9 reports estimated at $1977.29 per report = $17,795.62

Total Cost = $17,795.62

Mean cost per site/firm = $17,795.62/8 sites = $2,224.45/site

Rule familiarization: 7 hours/site x 8 sites = 56 hours

Reporting: 21.6 hours/report x 9 reports = 194 hours

Total burden hours = 250 hours

Average burden per site/firm = 250 hours/8 sites = 31.3 hours/site

The annual costs to the Federal Government will be approximately 0.0227 FTEs (or 47.25 hours annually). At an estimated $75,306 per FTE, the total 0.0227 FTEs ($1709.45), plus $1,834.92 for data processing, will cost EPA $3,544.37.

The Office of Management and Budget (OMB) has exempted actions under TSCA section 8(a) related to the PAIR rule from the requirements of Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

This action does not involve special considerations of environmental justice-related issues pursuant to Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), does not apply to this final rule, because it is not “economically significant” as defined under Executive Order 12866, and does not concern an environmental health or safety risk that may have a disproportionate effect on children. This rule requires the reporting of production, importation, use, and exposure-related information to EPA by manufacturers (including importers) of certain chemicals recommended in the 41st Report of the TSCA ITC.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq. , the Agency hereby certifies that this rule will not have a significant impact on a substantial number of small entities. The factual basis for the Agency's determination is presented in the small entity analysis prepared as a part of the Economic Analysis for this rule, and is briefly summarized here. Three of the six firms identified as manufacturers of chemicals affected by this rule met the Small Business Administration definition of a small business, (i.e., having less than 1,000 employees when combined with any corporate parents). Based on the Agency's analysis, the maximum potential impact of this action on an individual firm is estimated to be less than $2,224, regardless of the firm's size. To determine the potential significance of the estimated impact of this action on the small firms, the Agency compared the estimated maximum potential cost with the estimated annual sales revenue for these firms. Based on currently available financial information for these firms, EPA has determined that this action will not result in a significant impact on any of these firms. Information relating to this EPA determination is included in the docket for this rulemaking (OPPTS-82054). Any comments regarding the economic impacts that this action imposes on small entities should be submitted to the Agency at the address listed under FOR FURTHER INFORMATION CONTACT .

Pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq. ), an Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information that is subject to approval under the PRA unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations, after appearing in the preamble of the final rule, are listed in 40 CFR part 9, and included on the related collection instrument. The information collection activities related to this action have already been approved by OMB, under OMB control number 2070-0054 (EPA ICR No. 586) for PAIR reporting. This action does not impose any burdens requiring additional OMB approval. The public reporting burden for this collection of information is estimated to be 250 hours. Of that total, an estimated 56 hours are spent in an initial review of the rule, and the remaining 194 hours are associated with actual reporting activities (Economic Analysis). Because this rule does not contain any new information collection activities, additional review and approval of these activities by OMB under the PRA is not necessary.

Pursuant to Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, EPA has determined that this rule does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any 1 year. In addition, EPA has determined that this rule will not significantly or uniquely affect small governments. Accordingly, the rule is not subject to the requirements of UMRA sections 202, 203, 204, or 205.

Based on EPA's experience with past TSCA section 8(a) rulemakings, State, local, and tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or tribal government will be impacted by this rulemaking. As a result, this action is not subject to the requirement for prior consultation with Indian tribal governments as specified in Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governments (63 FR 27655, May 19, 1998). Nor will this action 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).

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). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. EPA invites public comment on the Agency's determination that this regulatory action does not require the consideration of voluntary consensus standards.

In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988, entitled Civil Justice Reform (61 FR 4729, February 7, 1996).

EPA has complied with Executive Order 12630, entitled Governmental Actions and Interference with Constitutionally Protected Property Rights (53 FR 8859, March 15, 1988), by examining the takings implications of this rule in accordance with the Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings issued under the Executive Order.

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. Section 808 allows the issuing agency to make a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). EPA has made such a good cause finding for this final rule, and established an effective date of August 4, 2000. Pursuant to 5 U.S.C. 808(2), this determination is supported by the brief statement in Unit VIII. EPA will submit a report containing this final 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 . This is not a “major rule” as defined by 5 U.S.C. 804(2).

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-276, adopted June 14, 2000, and released June 23, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 1231 20th Street, NW, Washington, DC 20036.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-353, adopted June 14, 2000, and released June 23, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-348, adopted June 7, 2000, and released June 16, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Information Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-350, adopted June 7, 2000, and released June 16, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC's Reference Center (Room CY-A257), 445 Twelfth Street, SW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Service, Inc., 1231 20th Street, NW., Washington, DC 20036, (202) 857-3800.

This is a synopsis of the Commission's Report and Order, MM Docket No. 99-50, adopted June 7, 2000, and released June 16, 2000. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW, Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractors, International Transcription Service, Inc., (202) 857-3800, 1231 20th Street, NW., Washington, DC 20036.

The FAR published a final rewrite of FAR Part 25, Foreign Acquisition, in the Federal Register on December 27, 1999 (64 FR 72414). This rule reorganizes the GSAR for consistency with the FAR changes. It also eliminates a provision and a clause, which duplicate coverage in the FAR, regarding evaluation of offers and delivery under contracts subject to trade agreements. It does not place any new requirements on offerors or contractors.

The FAR published a final rule on use of brand name or equal purchase descriptions in the Federal Register on June 17, 1999 (64 FR 32740). This rule eliminates a GSAR provision that duplicates coverage now contained in the provision at FAR 52.211-6, Brand Name or Equal.

For invoice payments made by GSA, payment information is available on the Internet. This rule provides a clause to notify contractors that the information is available and how to access it. A GSA contractor may access this information at its discretion to track the date and amount of payments made by GSA. Access to timely payment information may help a contractor to improve its financial management.

This rule also clarifies that certain provisions and clauses prescribed at GSAR 537.110 do not apply to contracts for building services initiated under the authority of the Javits-Wagner-O'Day Act (JWOD). The provision at GSAR 552.237-70, Qualifications of Offerors, and the clause at 552.237-71, Qualifications of Employees, do not apply to JWOD contract actions. Qualifications of JWOD participating nonprofit agencies are established by the Committee for Purchase from People Who Are Blind or Severely Disabled (see FAR subpart 8.7). This clarification will help avoid potential conflict with the rules established by the Committee, which have precedence.

This rule was not subject to Office of Management and Budget review under Section 6(b) of Executive Order 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

The final rule does not constitute a significant GSAR revision within the meaning of FAR 1.501 and Public Law 98-577, and publication for public commenters is not required. However, GSA will consider comments from small entities concerning the affected GSAR parts in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S. 601, et seq. , in correspondence.

The Paperwork Reduction Act does not apply because the changes to the GSAR do not impose recordkeeping or information collection requirements, or otherwise collect information from offerors, contractors, or members of the public that require approval of the Office of Management and Budget under 44 U.S.C. 3501 et seq.

This rule is not a major rule under 5 U.S.C. 804. This rule was submitted to Congress and GAO under 5 US.C. 801.

GSA expects this rule will have no significant cost or administrative burden on contractors or offerors. The changes improve clarity and avoid potential conflicts with FAR rules.

The following provision and clauses apply to contracts for building services:

(a) If the contract is expected to exceed the simplified acquisition threshold and it is not initiated under the Javits-Wagner-O'Day Act:

(1) Insert 552.237-70, Qualifications of Offerors, in the solicitation.

(2) Insert 552.237-71, Qualifications of Employees, in the solicitation and contract. If needed, use supplemental provisions or clauses to describe specific requirements for employees performing work on the contract.

(b) Insert 552.237-72, Prohibition Regaring “Quasi-Military Armed Forces,” in solicitations and contracts for guard service.

The Gulf of Mexico shrimp fishery is managed under the Fishery Management Plan for the Shrimp Fishery of the Gulf of Mexico (FMP). The FMP was prepared by the Gulf of Mexico Fishery Management Council and is implemented by regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act.

The EEZ off Texas is normally closed to all trawling each year from 30 minutes after sunset on May 15 to 30 minutes after sunset on July 15. The regulations at 50 CFR 622.34(h) describe the area of the Texas closure and provide for adjustments to the beginning and ending dates by the Regional Administrator, Southeast Region, NMFS, under procedures and restrictions specified in the FMP.

The beginning and ending dates of the Texas closure are based on biological sampling by Texas Parks and Wildlife Department (TPWD). The closure date is established based on projected times that brown shrimp in Texas bays and estuaries will reach a mean size of 90 mm, and begin strong emigrations out of the bays and estuaries during maximum duration ebb tides. The waters off of Texas are re-opened to shrimping based on projections indicating that brown shrimp will reach a mean size of 112 mm, in concurrence with maximum duration ebb tides. Biological data collected by TPDW indicates that the criteria to end the Texas closure will be met on July 5, 2000. Accordingly, the time and date for ending the Texas closure is changed from 30 minutes after sunset on July 15, 2000, to 30 minutes after sunset on July 5, 2000.

This action is authorized by 50 CFR 622.34(h)(2) and is exempt from review under Executive Order 12866.

A final rule was published in the Federal Register on November 15, 1999 (64 FR 61964), to revise recordkeeping and reporting regulations. The requirement that the operator of a catcher vessel is required to make records available for inspection upon the request of an authorized officer was inadvertently omitted from 50 CFR part 679.

In the final rule Revisions to Recordkeeping and Reporting Requirements published in 64 FR 61964, November 15, 1999, FR Doc. 99-28294, on page 61974, in the third column, remove § 679.5(a)(13)(i) and add in its place the following: