The objectives of our final rule are to:

• Ensure that association shareholders continue to receive the information they need about how their associations' relationships with related banks affect their own investments in the associations; and

• Allow banks (and indirectly their related associations and their shareholders) to save significant printing and mailing costs by relaxing the requirement that they must routinely distribute their annual reports to the shareholders of their related associations.

This final rule is part of the FCA's continuing efforts to reduce unnecessary regulatory burden on the Farm Credit System (FCS or System). On August 18, 1998, we published a notice in the Federal Register that invited the public to identify existing regulations that impose unnecessary burden on the System.1 Two FCS institutions asked us to repeal § 620.4(b)(1), which requires any Farm Credit bank that presents its financial statements on a combined basis with its related associations to distribute its annual report separately to the associations' shareholders.

On March 17, 2000, the FCA proposed amendments to the disclosure requirements in part 620 of its regulations (65 FR 14494). The proposed rule provided, in general, that a bank need not distribute its annual report to the shareholders of any related association that disclosed, in a separate section of its annual report, specified information about its financial and supervisory relationship with the bank. The proposed rule, however, required any System bank that experienced a “significant event” to distribute its annual report to the shareholders of its related associations.

The rule that we proposed had two objectives. First, the proposed rule ensured association shareholders would continue to receive information about the associations' relationship with its funding bank and how that relationship may affect the shareholders' investments in the association. Second, the proposed rule relaxed the requirement that System banks must routinely distribute their annual reports to the shareholders of their related associations. Relaxing this requirement allows banks to save significant printing and mailing costs. The banks, in turn, can pass these cost savings on to their related associations, which can pass the savings on to their shareholders.

The FCA received four comment letters on the proposed rule; one each from: the Accounting Standards Work Group (ASWG), the Farm Credit Council (FCC), a Farm Credit bank, and a System association. All commenters supported the proposed rule. However, the commenters asked us to clarify certain provisions of the proposed rule and offered suggestions to improve the regulations. We have responded to the commenters' requests in the final rule.

Existing § 620.4(b) requires FCS banks that present their financial statements on a combined basis with their related associations to distribute their annual reports to association shareholders. However, the regulation permits FCS banks that present their financial statements on a bank-only basis to distribute their annual reports to the shareholders of their related associations only when the bank experiences a significant event that has a material effect on its associations.

The proposed rule would no longer have required an FCS bank to routinely distribute its annual report to the shareholders of a related association that disclosed, in a separate section of its annual report, specified information about its financial and supervisory relationship with the bank. Distribution of the report by the bank would have been required, however, whenever an FCS bank experienced a “significant event,” as defined in existing § 620.1(r).2

The “separate section” would not have required any “new” disclosure. Currently, §§ 620.5 and 620.2(h)(2) specify the information that associations must include in this separate section. The proposed rule, however, would have provided banks with relief from the distribution requirement only if each related association presented this information in a separate section of its annual report. The separate section about the association's financial and supervisory relationship with the bank could have incorporated “by reference” information from other sections of the annual report. This separate section of the association's annual report would have included the following information, which is already required by § 620.5, when applicable:

• The association's obligation to borrow only from the bank (unless the bank gives the association approval to borrow elsewhere);

• The major terms of any capital preservation, loss sharing, or financial assistance agreements between the association and the bank;

• Any statutory or bank bylaw provisions authorizing bank access to the capital of the association;

• The extent the bank assumed the association's exposure to interest rate risk; and

• Any other material operational and financial conditions contributing to an interdependent relationship between the association and the bank.

The commenters supported the FCA's proposal to apply the same regulatory standards to all FCS banks, regardless of whether they prepare their financial statements on a bank-only basis or a combined basis with their affiliated associations. In addition, the commenters were not opposed to association disclosure of information about the financial and supervisory relationship with their funding banks in a separate section of their annual reports.

Three commenters, however, expressed concern that a bank's obligation to distribute its annual report to association shareholders hinged on a related association's decision to disclose relevant information about its relationship with its funding bank in a separate section of its annual reports. The FCS bank commented that it does not control the annual financial statements of its associations, which are audited by independent certified public accountants and, therefore, “the bank is fundamentally dependent on the actions of the associations to determine whether a distribution of annual reports is required.” In addition, the commenter stated that the proposed rule places “the onus on the bank for distributing bank annual reports for failure of its related association(s) to comply with FCA regulations.”

As an alternative, the ASWG, which is made up of staff from both banks and associations, suggested that the final rule require each association to disclose in a separate section of its annual report adequate information about its relationship with its funding bank. The ASWG also stated that a bank should be responsible for distribution of its annual report to its associations' shareholders only when the requirement to distribute is triggered by a “significant event.”

The FCA responds to the commenters' concerns by adopting a final rule that requires all FCS associations to disclose in a separate section of their annual reports specified information about their financial and supervisory relationship with their funding bank. The final rule, like the proposed rule, does not create any new disclosure requirements for banks or associations. In fact, the final rule only requires that associations reorganize information in their annual reports they have always disclosed. Final § 620.5(a)(10) now requires associations to address their relationship with their funding bank in a separate section of their annual report. As a result, the final rule does not impose any additional burdens on FCS associations.

The new separate section requirement replaces the existing provision on FCS banks' annual report distribution. Final § 620.4(b) no longer requires any FCS bank to distribute its annual report to association shareholders unless it “experiences a significant event that has a material effect on the associations.” Under the final rule, the same shareholder disclosure standards apply to all FCS banks. FCS banks that prepare their financial statements on a combined basis with their related associations are subject to the same requirement for distributing annual reports to association shareholders as FCS banks that prepare their financial statements on a bank-only basis.

The final rule addresses the commenters' concerns about the disclosure obligations of both FCS banks and associations. The final rule clarifies that System banks are not responsible for ensuring that each related association disclose in a separate section of its annual report information about its relationship with the funding bank. Under the final rule, a System bank must distribute its annual report directly to association shareholders only when it experiences a significant event that has a material effect on its related associations. As a result, the final rule saves banks the significant costs of routinely distributing its annual report to association shareholders. Additionally, FCS banks will not need to oversee the preparation of annual reports by their related associations because final § 620.5 specifies the information that associations must disclose in their annual reports.

Two commenters expressed concern that FCS banks could not distribute their annual report within the 90-day time frame established by proposed § 620.4(b)(2) if an association's annual report failed to disclose information about its financial and supervisory relationship with the bank. The final rule addresses the concerns by removing the proposed bank disclosure requirement that was based on an association's failure to disclose.

Our approach in the final rule also simplifies disclosure by FCS associations without sacrificing safety and soundness. By requiring a separate section of each association's annual report to disclose information already contained in the annual report about its relationship with the bank, the association's shareholders will have easy access to information that could affect their own investments in the FCS. In addition, we made two clarifying changes in § 620.5(a)(10)(iii) and (v) to explain the existing requirements. These changes are not substantive and they impose no new or additional burden on associations.

Existing § 620.2(h) requires System institutions to provide telephone numbers and addresses where shareholders may obtain copies of certain financial reports. The proposed amendments would have expanded this requirement by providing that annual reports must contain the telephone numbers and addresses (including, if available, electronic mail and Web site addresses) where shareholders may obtain copies of the reports.

The FCC construed the proposed regulation as requiring all institutions to make their financial reports available on their Web sites. Further, the ASWG stated the regulations should not “attempt to address all possible means for obtaining reports.” Accordingly, final § 620.2(h) permits, but does not require, System institutions to offer their shareholders additional means to request copies of financial reports, beyond the traditional telephone numbers and mailing addresses. If an institution has no other available means besides traditional telephone numbers and mailing addresses, the rule does not require the institution to take action to make other options available to its shareholders.

Existing § 620.4(a) requires a System institution to prepare and distribute to its shareholders an annual report. While the proposed rule did not include any suggested changes to this section, the FCC noted the FCA does not specify the medium to be used by System institutions for providing information to their shareholders. The FCC stated that “delivery of information through an electronic medium generally could satisfy delivery or transmission obligations under the Farm Credit Act and Regulations.” While the FCC did not specifically recommend that FCA amend § 620.4(a) to allow both paper and electronic distribution of shareholder reports, the FCC suggested that we should address this issue.

In this regard, the FCA has an internal task force that is reviewing electronic commerce issues. This task force will present its findings and make recommendations to the FCA Board that may address this issue. Meanwhile, existing § 620.4(a) requires System institutions to “distribute” their annual reports on paper until the issuance of additional guidance in this area. However, our regulations do not prevent System institutions, if they so choose, from making their annual reports available on their Web sites.

A proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) by superseding AD 98-10-09, Amendment 39-10725 (63 FR 46160, August 31, 1998), which applies to ECF Model SA.315B, SA.316B, SA.316C, SE.3160, and SA.319B helicopters, was published in the Federal Register on December 1, 2000 (65 FR 75198). That action proposed to require, within 25 hours TIS and thereafter at intervals not to exceed 100 hours TIS or 600 cycles, whichever occurs first, inspecting each blade spar for a crack, using dye penetrant or eddy current, and inspecting each blade cuff to ensure an adequate sealant bead. A “cycle” is any landing, regardless of whether the main rotor rotation is continued or stopped, or any completion of an external load operation; e.g. load release. If a crack is found, the proposed AD would require replacing the blade with an airworthy blade before further flight.

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 but with one minor editorial change. Notes 4 and 5 in the proposal should have been Notes 3 and 4 respectively, and this AD corrects that error. The FAA has determined that this change will neither increase the economic burden on an operator nor increase the scope of the AD.

The FAA estimates that 93 helicopters of U.S. registry will be affected by this AD, that it would take approximately 4 hours to inspect and 4 hours to replace a blade, if necessary, and that the average labor rate is $60 per work hour. Based on these figures, the total cost impact of this AD on U.S. operators is estimated to be $66,960, assuming three inspections per year and no blade replacement.

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.

What events have caused this AD? The Luftfahrt-Bundesamt (LBA), which is the airworthiness authority for the Federal Republic of Germany, notified FAA that an unsafe condition may exist on all DG Flugzeugbau Model DG-500MB sailplanes equipped with a SOLO 2625 02 engine. The LBA reports that the service history for the SOLO 2625 02 engine shows a need to modify the front crank shaft bearing. Additionally, the digital engine indicator circuit breaker amperage is too low for use and needs replacement.

What are the consequences if the condition is not corrected? The actions specified by this AD are intended to correct an inadequate circuit breaker and unsatisfactory drive belt tension that could cause damage to the engine crankshaft. Such damage could lead to engine failure and loss of control of the sailplane.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain DG Flugzeugbau Model DG-500MB sailplanes equipped with a SOLO 2625 02 engine. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on December 27, 2000 (65 FR 81782). The NPRM proposed to require you install additional access holes in the propeller mount and modify the engine. The NPRM also proposed to require you to do a ground test run and replace the digital engine indicator circuit breaker.

Was the public invited to comment? Interested persons were afforded an opportunity to participate in the making of this amendment. No comments were received on the proposed rule or the FAA's determination of the cost to the public.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We determined that these minor corrections:

—Will not change the meaning of the AD; and

—Will not add any additional burden upon the public than was already proposed.

How many sailplanes does this AD impact? We estimate that this AD affects 1 sailplane in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected sailplanes? We estimate the following costs to accomplish the modification:

Does this AD impact various entities? 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.

Does this AD involve a significant rule or regulatory action? 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 copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

Has FAA taken any action to this point? Reports received from the Federal Office for Civil Aviation (FOCA), which is the airworthiness authority for Switzerland, revealed instances of corrosion and cracking in the elevator and rudder attachment brackets on Pilatus Model PC-7 airplanes that have been operated in areas of high humidity or salt content. This caused FAA to issue AD 98-08-22, Amendment 39-10471 (63 FR 19175, April 17, 1998). That AD requires you to inspect the elevator and rudder attachment brackets for cracks and/or corrosion, and replace any cracked or corrosion-damaged parts, as applicable.

What has happened since AD 98-08-22 to initiate this action? The FOCA recently notified FAA of the need to change AD 98-08-22. The FOCA reports that Pilatus has redesigned the elevator and rudder attachment brackets. Installation of these brackets should inhibit the cause of corrosion, which resulted in cracks or corrosion damage.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Pilatus Model PC-7 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on January 2, 2001 (66 FR 57). The NPRM proposed to supersede AD 98-08-22. AD 98-08-22 currently requires inspecting the elevator and rudder attachment brackets for cracks and corrosion, and replacing any cracked or corrosion-damaged parts. Since the issuance of AD 98-08-22, Pilatus has redesigned the brackets. Installation of these brackets should inhibit corrosion, which resulted in cracks or corrosion damage. The NPRM also proposed to require you to replace the elevator and rudder attachment brackets with parts of improved design.

Was the public invited to comment? Interested persons were afforded an opportunity to participate in the making of this amendment. No comments were received on the proposed rule or the FAA's determination of the cost to the public.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We determined that these minor corrections:

How many airplanes does this AD impact? We estimate that this AD affects 8 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the modification:

Why is the compliance in hours time-in-service (TIS) and calendar time? The affected airplanes are used in general aviation operations. Some operators may accumulate 100 hours TIS on the airplane in less than 6 months. We have determined that the dual compliance time:

Does this AD impact various entities? 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.

Does this AD involve a significant rule or regulatory action? 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 copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

What events have caused this AD? The Direction Generale de l'Aviation Civile (DGAC), which is the airworthiness authority for France, recently notified FAA that an unsafe condition may exist on certain Socata Model TBM 700 airplanes. The DGAC reports two occurrences on Socata model TBM 700 airplanes where, following a flight, a screw of a flap attachment fitting was found partly unscrewed and another was missing. These occurrences are the result of flap vibration.

What are the consequences if the condition is not corrected? Loose or the loss of flap attaching bolts/screws could result in rough or irregular control. Such rough or irregular control could lead to loss of control of the airplane.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to certain Socata Model TBM 700 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on January 2, 2001 (66 FR 64). The NPRM proposed to require you to apply Loctite on attaching bolt/screw threads of inboard, central, and outboard carriages; increase tightening torques of associated hardware; and replace central carriage attaching bolts.

Was the public invited to comment? Interested persons were afforded an opportunity to participate in the making of this amendment. No comments were received on the proposed rule or the FAA's determination of the cost to the public.

Socata has revised Service Bulletin No. SB 70-087 57, dated September 2000 (Amendment 1, dated November 2000), to incorporate minor procedural changes. This AD requires no further action if the original service bulletin is accomplished.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for the addition of the revised service information and minor editorial corrections. We determined that this addition and these minor corrections:

How many airplanes does this AD impact? We estimate that this AD affects 75 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the modification:

What events have caused this AD? The Ente Nazionale per l' Aviazione Civile (ENAC), which is the airworthiness authority for Italy, recently notified FAA that an unsafe condition may exist on all PIAGGIO Model P-180 airplanes. The ENAC reports incidents of malfunctions of the flap actuators. Investigation of these incidents reveals problems inside the gearbox of the outboard flap actuators. Investigation results indicate incorrect maneuvering of the flap system and evidence of grease and oxidation around the gear box.

What are the consequences if the condition is not corrected? Continued operation with problem actuators could result in flap system failure, with consequent reduction in, or loss of, control of the airplane.

Has FAA taken any action to this point? We issued a proposal to amend part 39 of the Federal Aviation Regulations (14 CFR part 39) to include an AD that would apply to all PIAGGIO Model P-180 airplanes. This proposal was published in the Federal Register as a notice of proposed rulemaking (NPRM) on January 2, 2001 (66 FR 61). The NPRM proposed to require you to:

Was the public invited to comment? Interested persons were afforded an opportunity to participate in the making of this amendment. No comments were received on the proposed rule or the FAA's determination of the cost to the public.

What is FAA's final determination on this issue? After careful review of all available information related to the subject presented above, we have determined that air safety and the public interest require the adoption of the rule as proposed except for minor editorial corrections. We determined that these minor corrections:

How many airplanes does this AD impact? We estimate that this AD affects 11 airplanes in the U.S. registry.

What is the cost impact of this AD on owners/operators of the affected airplanes? We estimate the following costs to accomplish the inspection:

Does this AD impact various entities? 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.

Does this AD involve a significant rule or regulatory action? 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 copy of the final evaluation prepared for this action is contained in the Rules Docket. A copy of it may be obtained by contacting the Rules Docket at the location provided under the caption ADDRESSES.

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

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

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

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

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

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

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

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

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

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

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

As published, the final regulations contain an error in the mailing address where an individual or entity shall submit a request for records, information or testimony.

Phoenix Scientific, Inc., 3915 South 48th Street Terrace, P.O. Box 6457, St. Joseph, MO 64506-0457, filed a supplement to approved NADA 094-170 for Phenylbutazone Tablets, USP. The supplemental NADA provides for use of a 200-mg strength phenylbutazone tablet for relief of inflammatory conditions associated with the musculoskeletal system in dogs and horses. The supplemental NADA is approved as of January 12, 2001, and the regulations are amended in 21 CFR 520.1720a to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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

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

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

We published a final rule (RIN 1029-AB40) on October 20, 1994 at 59 FR 53022. The rule revised regulations in 30 CFR parts 816 and 817. In both 30 CFR 816.49 and 817.49, OSM redesignated paragraphs (a)(8), (a)(9), and (a)(10) as (a)(9), (a)(10), and (a)(11) respectively. Redesignated paragraph (a)(9) still contains cross references to paragraphs (a)(8), (a)(8)(i) and (a)(8)(ii). Those cross references should have been revised to read (a)(9), (a)(9)(i) and (a)(9)(ii) when paragraph (a)(8) was redesignated as paragraph (a)(9). Similarly, redesignated paragraph (a)(11) contains cross references to paragraphs (a)(10)(i) and (a)(10)(iv). Those cross references should have been revised to read (a)(11)(i) and (a)(11)(iv) when paragraph (a)(10) was redesignated as paragraph (a)(11). In addition, both 30 CFR 816.49(c)(2) and 817.49(c)(2) contains a cross reference to (a)(8)(i) which, under the redesignation, should have been revised to (a)(9)(i). This rule corrects those errors. Finally, 30 CFR 816.49(a)(1) and 817.49(a)(1) contains references to OSM's Administrative Record Room which was located at 800 North Capitol Street, NW., Washington, DC when the rule was published. Since publication of the rule, we have moved the Administrative Record Room to 1951 Constitution Avenue, NW., Washington, DC. This rule revise paragraphs 816.49(a)(1) and 817.49(a)(1) to indicate the new address.

This final rule has been issued without prior public notice or opportunity for public comment. The Administrative Procedure Act (APA) (5 U.S.C. 553) provides an exception to the notice and comment procedures when an agency finds that there is good cause for dispensing with such procedures on the basis that they are impracticable, unnecessary or contrary to the public interest. OSM has determined that under 5 U.S.C. 553(b)(3)(B) good cause exists for dispensing with the notice of proposed rulemaking and public comment procedures for this rule. Specifically, this rule merely corrects references contained in the regulations and does not impose any new OSM regulatory requirements. These same reasons also provide OSM with good cause under 5 U.S.C. 553(d)(3) of the APA to have the regulation become effective on a date that is less than 30 days after the date of publication in the Federal Register.

This rule is not a significant rule and is not subject to review by the Office of Management and Budget under Executive Order 12866.

(1) This rule will not have an effect of $100 million or more on the economy. It will not adversely affect in a material way the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. As previously stated, this rule corrects references contained in the regulations and does not impose any new OSM regulatory requirements.

(2) This rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency for the reasons stated above.

(3) This rule does not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients.

(4) This rule does not raise novel legal or policy issues for the reasons stated above.

The Department of the Interior 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.). As previously stated, the rule merely corrects references contained in the regulations and does not impose any new OSM regulatory requirements.

For purposes of compliance with the Unfunded Mandates Reform Act of 1995, this rule does not impose any obligations that individually or cumulatively would require an aggregate expenditure of $100 million or more by State, local, and Tribal governments and the private sector in any given year.

This rule does not contain collections of information which require approval by the Office of Management and Budget under 44 U.S.C. 3501 et seq.

This rule has been reviewed by OSM and it has been determined to be categorically excluded from the requirement to prepare an environmental document under the National Environmental Policy Act of 1969. This determination was made in accordance with the Departmental Manual (516 DM 2, Appendix 1.10).

The Department of the Interior has determined that this rule meets the requirements of sections (3)(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform (61 FR 4729).

The rule will apply through cross-referencing to the following Federal program states: California, Georgia, Idaho, Massachusetts, Michigan, North Carolina, Oregon, Rhode Island, South Dakota, Tennessee and Washington. The Federal programs for these States appear at 30 CFR Parts 905, 910, 912, 921, 922, 933, 937, 939, 941, 942 and 947, respectively. The rule also applies through cross-referencing to Indian lands under the Federal program for Indian lands as provided in 30 CFR part 750.

Following promulgation of the final rule, OSM will evaluate State programs approved under section 503 of SMCRA to determine any changes in those programs that will be necessary. When OSM determines that a particular State program provision should be amended in order to be made no less stringent than the revised Federal regulations, the particular States will be notified in accordance with the provisions of 30 CFR 732.17.

On November 27, 2000 (65 FR 70676-70678), EPA published a Notice of Proposed Rulemaking (NPR) for the Commonwealth of Massachusetts. The NPR proposed approval of amendments to the Massachusetts Port Authority (Massport)/Logan Airport Parking Freeze and City of Boston/East Boston Parking Freeze. The revisions allows the Commonwealth to automatically approve the transfer of parking spaces from the East Boston Parking Freeze to the Logan Parking Freeze provided the total parking space inventory number for the Logan Parking Freeze remains at or below 21,790 parking spaces. Future modifications in the parking freeze inventories for the Logan Airport and East Boston Parking Freezes will be regulated by the Commonwealth's revisions to Massachusetts State Regulations 310 CMR 7.30 and 310 CMR 7.31. The formal SIP revision was submitted by Massachusetts on December 8, 2000 and December 26, 2000.

Originally, Massachusetts requested that EPA parallel process this SIP revision. In accordance with this process, EPA held a thirty day comment period which overlapped the Commonwealth's public participation period. During the Commonwealth's comment period, two comments were submitted to the Massachusetts Department of Environmental Protection (MA DEP) from Massport and from EPA-New England. Massport's comment provided substitution of the language in 310 CMR 7.30(5)(b) which enables MA DEP to keep an up-to-date administrative record of the Logan and East Boston Parking Freeze inventories. EPA-New England's comment addressed public access to information on the number of MA DEP-certified parking spaces in the Logan Airport and East Boston Parking Freeze areas. MA DEP has made a commitment to make these parking freeze inventory numbers available on its web site (http://www.magnet.state.ma.us/dep/dephome.htm) and will also encourage Massport and the City of Boston to do the same.

Other specific requirements of Massport/Logan Airport Parking Freeze and City of Boston/East Boston Parking Freeze, and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. No public comments were received by EPA on the NPR.

EPA is approving the modifications to Massachusetts State Regulations 310 CMR 7.30 “Massport/Logan Airport Parking Freeze” and 310 CMR 7.31 “City of Boston/East Boston Parking Freeze” as revisions to the Massachusetts SIP.

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 May 11, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

This Supplementary Information section is organized as follows:

Under CAA section 112(l), EPA may approve state or local rules or programs to be implemented and enforced in place of certain otherwise applicable CAA section 112 federal rules, emission standards, or requirements. The federal regulations governing EPA's approval of state and local rules or programs under section 112(l) are located at 40 CFR part 63, subpart E (see 59 FR 62262, November 26, 1993). Under these regulations, a local air pollution control agency has the option to request EPA's approval to substitute a local rule for the applicable federal rule (i.e., the federal National Emission Standards for Hazardous Air Pollutants (NESHAP)). Upon approval, the local agency is given the authority to implement and enforce its rule in place of the NESHAP. To receive EPA approval using this “rule substitution” option, the requirements of 40 CFR 63.91 and 63.93 must be met.

On December 1, 1998, (see 63 FR 66054), EPA promulgated direct final approval of the State of Washington Department of Ecology's (Ecology) request, on behalf of the Puget Sound Clean Air Agency 1 (Puget Sound Clean Air), for delegation of authority to implement and enforce certain 40 CFR parts 61 and 63 NESHAP rules, as they apply to both part 70 and non-part 70 sources (i.e., “area sources”). Ecology had submitted a request on behalf of Puget Sound Clean Air for approval of a rule adjustment for 40 CFR part 63, subpart M (dry cleaning NESHAP). The original request was dated January 16, 1997, with a correction letter dated September 4, 1997. EPA did not address this request in the December 1, 1998, rulemaking because EPA anticipated that approval of the requested rule adjustments would require a more detailed review under 40 CFR 63.92, and decided to address Puget Sound Clean Air's request for rule adjustments in a separate notice. After completing its review of Puget Sound Clean Air's request, EPA has determined that Puget Sound Clean Air's request does not qualify as a rule adjustment under 40 CFR 63.92. Instead, the request shall be treated as a request for a rule substitution as defined in 40 CFR 63.93. Therefore, EPA is acting on this request as a rule substitution according to 40 CFR 63.93.

Puget Sound Clean Air's dry cleaning rule differs in several ways from the federal dry cleaning NESHAP. Many of these differences make Puget Sound Clean Air's regulations more stringent than the federal NESHAP. However, some of the provisions of Puget Sound Clean Air's dry cleaning regulations require further clarification to explain how they are at least equivalent to the federal dry cleaning NESHAP. In a letter dated June 9, 2000, Puget Sound Clean Air committed to interpreting and implementing its dry cleaning rule consistent with the explanations provided in this section so that its rule is more stringent or as stringent as the federal dry cleaning NESHAP.

In 40 CFR 63.320(g), the federal NESHAP classifies dry cleaning sources based on either annual perchloroethylene (“perc”) emissions or annual perc consumption. Major sources are those sources with either 10 tpy perc emissions or perc consumption greater than 8000 Liters (2100 gallons) for dry to dry machines or greater than 6800 liters (1800 gallons) for transfer or transfer & dry to dry machines. Puget Sound Clean Air's regulation use only perc emissions to identify major sources. Puget Sound Clean Air Regulation I, section 1.07(aa) defines Major Source of Hazardous Air Pollutant (HAP) as one that emits 10 tpy of a single HAP (such as perc). EPA believes that this definition adequately captures all major source dry cleaning facilities within Puget Sound Clean Air's jurisdiction. For both the federal and the Puget Sound Clean Air regulations, area sources are those sources which do not meet the criteria listed above. Puget Sound Clean Air's regulation applies to all dry cleaning systems using perc (Puget Sound Clean Air Regulation III, section 3.03(a)). Therefore, EPA believes that this requirement captures all area source dry cleaning facilities within Puget Sound Clean Air's jurisdiction.

Puget Sound Clean Air's request for approval included only those provisions of the dry cleaning NESHAP that apply to area sources. Thus, percholorethylene dry cleaning facilities that qualify as major sources, will remain subject to the federal NESHAP (40 CFR part 63, subpart M), as adopted by reference into Puget Sound Clean Air Regulation III, section 2.02. Additionally, major sources are required to obtain a Title V permit (Puget Sound Clean Air Regulation III, section 3.03[h]).

In 40 CFR 63.320(b), the federal dry cleaning NESHAP states that new facilities constructed after 12/09/91 must comply upon startup. Puget Sound Clean Air's regulations do not specifically address this because Puget Sound Clean Air has been regulating its dry cleaning facilities since before 12/09/91, and all sources constructed after this date would be required to install Best Available Control Technology (BACT) upon startup. BACT is more stringent than MACT (in this case, BACT would be a nonventing, closed loop machine, while MACT would not be closed loop and would allow venting), so Puget Sound Clean Air's regulation would be more stringent for new sources. Also, for existing sources that are modified or upgraded, they would be required by Puget Sound Clean Air's regulations to vent to a refrigerated condenser which EPA considers to be equivalent to the MACT.

Puget Sound Clean Air's dry cleaning regulation does not include all of the same definitions as the federal dry cleaning NESHAP. Puget Sound Clean Air determined that some of the terms are defined elsewhere in its regulations, and that some definitions are not necessary for its dry cleaning regulation. In its equivalency determination, Puget Sound Clean Air stated that if a conflict arises in defining terms, it will defer to the definitions in the federal dry cleaning NESHAP.

The federal dry cleaning NESHAP states in 40 CFR 63.322(f)(3), that washers shall not share refrigerated condensers (RC) with any other equipment. Puget Sound Clean Air's regulations do not address this section because no current facilities share the RC and no new transfer machines are permitted. This is acceptable to EPA based on the understanding that no new transfer machines will be permitted and that there are no new (or existing) facilities that couple their RC with any other equipment.

In 40 CFR 63.322(j), the federal dry cleaning NESHAP requires that perc must be put into a solvent tank or solvent container with “no perceptible leaks.” Puget Sound Clean Air Regulation I, section 3.03(c)(4) requires that perc be put into a “closed container.” Puget Sound Clean Air has clarified that a “closed container” will be interpreted as a container that has “no perceptible leaks.”

In 40 CFR 63.322(k), the federal dry cleaning NESHAP requires weekly perceptible leak inspections and identifies the specific components which must be inspected. Puget Sound Clean Air's rule at Regulation III, section 3.03(c)(1) requires a visual inspection of the “dry cleaning system.” EPA has confirmed that Puget Sound Clean Air's interpretation of the requirement in section 3.03(c)(1) to conduct a visual inspection is that this inspection must include a weekly inspection of all the parts listed in 40 CFR 63.322(k) and must be conducted when the dry cleaning system is operating.

In 40 CFR 63.322(n), the federal dry cleaning NESHAP states that if a RC or carbon absorber (CA) does not meet the monitoring parameter limits, then adjustments or repairs shall be made to the dry cleaning system or control device to meet those values. It also states that if repair parts must be ordered, then a written or verbal order for these parts shall be initiated within 2 working days of detecting such parameter value. Additionally, these repair parts shall be installed within 5 working days after receipt. Puget Sound Clean Air Regulation III, section 3.03(f)(1), does not specify the time period in which to repair the dry cleaning system. Instead, it refers to Puget Sound Clean Air Regulation I, section 5.05(e), which states that a dry cleaner's operation and maintenance plan shall include “prompt” repair of any defective equipment or control equipment. EPA and Puget Sound Clean Air interpret this regulation as requiring repair within the time frames required by the federal dry cleaning NESHAP.

Puget Sound Clean Air's Regulation III, section 3.03(e)(2) does not provide a specific requirement regarding the use of a colorimetric tube. In 40 CFR 63.323(b)(2) and (3), the federal dry cleaning NESHAP describes where to place a sampling port and states that the colorimetric tube should be used according to the manufacturer's instructions. Puget Sound Clean Air has agreed to implement Puget Sound Clean Air Regulation III, section 3.03(e)(2) consistent with the requirements of section 63.323(b) of the federal dry cleaning NESHAP regarding the use of the colorimetric tubes, including the correct placement of the sampling port.

In 40 CFR 63.324(d), the federal dry cleaning NESHAP requires a facility to maintain records on site for a minimum of 5 years. Puget Sound Clean Air's Regulation I, section 5.05(e) does not specify a time frame that a facility must maintain records on site. Both EPA and Puget Sound Clean Air interpret section 5.05(e) to require that records must be maintained indefinitely.

In 40 CFR 63.324(e), the federal dry cleaning NESHAP requires a facility to maintain on-site design specs and operating manuals for each system and control device. Puget Sound Clean Air's Regulation III, section 3.03(c)(5) states that facilities shall operate and maintain the dry cleaning system according to manufacturer's specifications and recommendations. EPA agrees with Puget Sound Clean Air's interpretation of section 3.03(c)(5) that, in order to follow a manufacturer's specifications, a dry cleaner must maintain an operating manual.

Under the federal dry cleaning NESHAP, any person may petition the EPA Administrator for a determination that the use of certain equipment or procedures is equivalent to the standards contained in the dry cleaning NESHAP (see 40 CFR 63.325). In its request, Puget Sound Clean Air requested approval for the provisions in Puget Sound Clean Air Regulation I, section 3.23, that would allow for the use of alternative emission control technology without previous approval from EPA. However, CAA section 112(h)(3) limits EPA's authority to approve alternative standards solely to the EPA Administrator. A source seeking permission to use an alternative means of emission limitation under CAA section 112(h)(3) must receive approval, after notice and opportunity for comment, from EPA before using such alternative means of emission limitation for the purpose of complying with CAA section 112. Therefore, EPA cannot approve Puget Sound Clean Air's request for authority to approve alternative emission control technologies.

After reviewing the request for approval of Puget Sound Clean Air's dry cleaning rules, EPA has determined that this request meets all of the requirements necessary to qualify for approval under CAA section 112(l) and 40 CFR 63.91 and 63.93. EPA has determined that Puget Sound Clean Air's dry cleaning rule is equivalent or more stringent than the federal dry cleaning NESHAP. Therefore, EPA hereby approves Puget Sound Clean Air's dry cleaning rule to be used in place of the federal dry cleaning NESHAP, as it applies to area sources in Puget Sound Clean Air's jurisdiction. As of the effective date of this action, Puget Sound Clean Air's dry cleaning rule is enforceable by the EPA and citizens under the CAA. Although Puget Sound Clean Air has primary implementation and enforcement responsibility, EPA retains the right, pursuant to CAA section 112(l)(7), to enforce any applicable emission standard or requirement under CAA section 112.

In response to Puget Sound Clean Air's original request for NESHAP program approval and delegation of authority, EPA had only granted interim approval to Puget Sound Clean Air (see 61 FR 43675) because Ecology's statute addressing criminal authorities, RCW 70.94.430, which Puget Sound Clean Air implements, did not meet the stringency requirements of 40 CFR 70.11 and 40 CFR 63.91. Ecology addressed these issues in a letter dated October 7, 1996. This letter included a legal memorandum from the Washington State Attorney General's Office dated May 23, 1996, explaining how the statutory authority in RCW 70.94.430(1) may be interpreted to provide the required authority for criminal penalties. Ecology also amended the State regulation at Washington Administrative Code (WAC) 173-400-105(7) and (8) to include prohibitions against knowingly making false statements and knowingly rendering inaccurate any monitoring device. In a letter dated February 28, 1997, Ecology provided supporting documentation from Puget Sound Clean Air. In this documentation, Puget Sound Clean Air committed to enforcing WAC 173-400-105(7) and (8) until such time as it might adopt its own equivalent regulations. Based on this information, EPA determined that Puget Sound Clean Air has adequate criminal authorities to meet the requirements of 40 CFR 70.11 and 40 CFR 63.91 (see 63 FR 66054 for Puget Sound Clean Air's final NESHAPs approval and delegation of authority).

As stated in section II.B. above, EPA retains the right, pursuant to CAA section 112(l)(7), to enforce any applicable emission standard or requirement under CAA section 112, including the authority to seek civil and criminal penalties up to the maximum amounts specified in CAA section 113.

Puget Sound Clean Air Regulation I, section 3.23, “Alternate Means of Compliance,” provides for the granting of variances under certain circumstances. EPA regards these provisions as wholly external to Puget Sound Clean Air's request for approval to implement and enforce a CAA section 112 program or rule and, consequently, does not approve this provision as part of this action. EPA does not recognize the ability of a State or local agency who has received delegation of a CAA section 112 program or rule to grant relief from the duty to comply with such Federally-enforceable program or rule, except where such relief is granted in accordance with procedures allowed under CAA section 112. As stated above, EPA retains the right, pursuant to CAA section 112(l)(7), to enforce any applicable emission standard or requirement under CAA section 112. As mentioned in section II.A.12 above, a source seeking permission to use an alternative means of emission limitation under CAA section 112 must also receive approval, after notice and opportunity for comment, from EPA before using such alternative means of emission limitation for the purpose of complying with CAA section 112.

Under the Puyallup Tribe of Indians Settlement Act of 1989, Congress provided state and local agencies, such as Puget Sound Clean Air, authority over activities on non-trust lands within the 1873 Survey Area. As of the effective date of this action, Puget Sound Clean Air will be implementing and enforcing its dry cleaning rule, as it applies to area sources on the non-trust lands within the 1873 Survey Area, in place of the federal dry cleaning NESHAP. EPA consulted with the Puyallup Tribe by letter dated January 11, 2000 regarding this action, and received no adverse comments from the Tribe.

EPA views the approval of Puget Sound Clean Air's request to use its Perchloroethylene Dr Cleaners regulation as a substitute for the federal dry cleaning NESHAP as a noncontroversial action and anticipates no adverse comments. Therefore, EPA is publishing this direct final rule without prior proposal. However, in the Proposed Rules section of this Federal Register publication, EPA is publishing a separate document that will serve as the proposal for this action should relevant adverse comments be filed. This action will be effective on May 11, 2001 without further notice, unless EPA receives relevant adverse comments by April 11, 2001.

If EPA receives such comments, then it will publish a timely withdrawal in the Federal Register informing the public that this direct final rule will not take effect. All public comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this rule. Any 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 May 11, 2001 and no further action will be taken on the proposed rule.

Pursuant to section 112(l) of the CAA and 40 CFR 63.91 and 63.93, EPA is approving Ecology's request for Puget Sound Clean Air to implement and enforce Puget Sound Clean Air's Regulation III, section 3.03, Perchloroethylene Dry Cleaners (section 3.03) in place of 40 CFR part 63, subpart M, National Perchloroethylene Air Emission Standards for Dry Cleaning Facilities, as it applies to area sources. This approval makes Puget Sound Clean Air's rules federally enforceable and reduces the burden on area sources within Puget Sound Clean Air's jurisdiction such that they only have one rule with which they must comply. Major sources remain subject to 40 CFR part 63, subpart M, as adopted into Puget Sound Clean Air Regulation III, section 2.02.

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

This rule is not subject to Executive Order 13045, entitled, “Protection of Children from Environmental Health Risks and Safety Risks,” because it is not an “economically significant” action under Executive Order 12866.

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. The 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 does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, because it merely approves a State program and rules implementing a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. Thus, Executive Order 13132 does not apply to this rule.

Although section 6 of the Executive Order does not apply to this rule, EPA did consult with representatives of State and local governments in developing this rule, and this rule is in response to the State's and local's delegation request.

Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly 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. If the mandate is unfunded, EPA must 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 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.”

This 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.

Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 600, et seq., EPA must prepare a regulatory flexibility analysis assessing the impact of any rule on small entities. 5 U.S.C. 603 and 604. Alternatively, EPA may certify 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 government entities with jurisdiction over populations of less than 50,000.

This final rule will not have a significant impact on a substantial number of small entities because approvals under 40 CFR 63.93 do not create any new requirements, but simply approve requirements that the state or local agency is already imposing. Therefore, because this action does not impose any new requirements, I certify that it does not have a significant economic impact on a substantial number of small entities.

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 annual costs to state, local, or tribal governments in the aggregate, or to 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 delegation action promulgated does not include a federal mandate that may result in estimated annual 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 federal 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. This rule is not a “major” rule as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by May 11, 2001. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

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

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

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http://www.epa.gov/. To access this document, on the Home Page select “Laws and Regulations,” “Regulations and Proposed Rules,” and then look up the entry for this document under the “Federal Register—Environmental Documents.” You can also go directly to the Federal Register listings at http://www.epa.gov/fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, a beta site currently under development.

2. In person. The Agency has established an official record for this action under docket control number OPP-301104. 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 December 20, 2000 (65 FR 79839) (FRL-6760-6), EPA issued a notice pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the filing of a pesticide petition (PP 1E6239) by Miller Chemical and Fertilizer Corporation, P.O. Box 333, Radio Road, Hanover, PA 17331. This notice included a summary of the petition prepared by the petitioner. There were no comments received in response to the notice of filing.

The petition requested that 40 CFR 180.1001 (c) and (e) be amended by establishing an exemption from the requirement of a tolerance for residues of butene, homopolymer; (CAS Reg. No. 9003-29-6).

Section 408(c)(2)(A)(i) of the FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(c)(2)(A)(ii) 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 an exemption from the requirement of 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...” and specifies factors EPA is to consider in establishing an exemption.

Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.

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. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers that should present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b). The following exclusion criteria for identifying these low risk polymers are described in 40 CFR 723.250(d).

1. The polymer, butene, homopolymer, is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its compostion the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer, butene, homopolymer, also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average molecular weight (MW) of 1,330 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups.

Thus, butene, homopolymer meets all the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the above criteria, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to butene, homopolymer.

For the purposes of assessing potential exposure under this exemption, EPA considered that butene, homopolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of butene, homopolymer is 1330 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since butene, homopolymer conforms to the criteria that identify a low risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or tolerance exemption, the Agency consider “available information” concerning the cumulative effects of a particular chemical's residues and “other substances that have a common mechanism of toxicity.” The Agency has not made any conclusions as to whether or not butene, homopolymer shares a common mechanism of toxicity with any other chemicals. However, butene, homopolymer conforms to the criteria that identify a low risk polymer. Due to the expected lack of toxicity based on the above conformance, the Agency has determined that a cumulative risk assessment is not necessary.

Based on the conformance to the criteria used to identify a low risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population from aggregate exposure to residues of butene, homopolymer.

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 concludes that a different margin safety will be safe for infants and children. Due to the expected low toxicity of butene, homopolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

There is no available evidence that butene, homopolymer is an endocrine disruptor.

Currently there is an existing tolerance exemption under (40 CFR 180.1037) for polybutylene, which is also known as butene, homopolymer.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

The Agency is not aware of any country requiring a tolerance for butene, homopolymer nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Accordingly, EPA finds that exempting residues of butene, homopolymer from the requirement of a tolerance will be safe.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301104 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 May 11, 2001.

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

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

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

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

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

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VIII.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301104 to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

This final rule establishes 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 special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under 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). For these same reasons, the Agency has determined that this rule does not have any “tribal implications” as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

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

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

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

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

2. In person. The Agency has established an official record for this action under docket control number OPP-301088. 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 February 13, 1997 (PP 5F4558) (62 FR 6780) (FRL-5587-3), April 2, 1997 (PP 6F4676) (62 FR 15700) (FRL-5594-9), July 11, 1997 (PP 6F4611) (62 FR 37246) (FRL-5723-1), and September 17, 1997 (PP 2E4042, 2E4018 and 6E4672) (62 FR 48849) (FRL-5735-8), EPA issued notices pursuant to section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) announcing the filing of pesticide petitions (PP) for tolerances by ISK Biosciences Corporation, 15966 Heisley Road, P.O. Box 8000, Mentor, OH 44061-8000 and Interregional Research Project Number 4 (IR-4), New Jersey Agricultural Experimental Station, P.O. box 231, Rutgers University, New Brunswick, NJ 08903. These notices included a summary of the petition prepared by ISK Biosciences Corporation and IR-4, the registrants. The active ingredient has since been transferred to GB Biosciences Corporation, 1800 Concord Pike, P.O. Box 15458, Wilmington, DE 19850-5458. There were no comments received in response to the notices of filing.-

The petitions requested that 40 CFR 180.275 be amended by establishing tolerances for combined residues of the fungicide chlorothalonil, tetrachloroisophthalonitrile and its metabolite, 4-hydroxy-2,5,6-trichloroisopthalonitrile (SDS-3701), in or on almonds (nutmeats) at 0.05 part per million (ppm), almond hulls at 1.0 ppm, asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm, and pistachios at 0.2 ppm, and for residues of the metabolite SDS-3701 in or on the following milk and meat commodities: fat of cattle, hogs, goats, horses, and sheep at 0.1 ppm; kidney of cattle, hogs, goats, horses and sheep at 0.5 ppm; meat byproducts (mbyp) (except kidney) of cattle, goats, hogs, horses and sheep at 0.05 ppm and meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and milk at 0.1 ppm. -

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

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

Consistent with section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2), for tolerances for combined residues of chlorothalonil and its metabolite SDS-3701 in or on almonds (nutmeats) at 0.05 ppm, almond hulls at 1.0 ppm, asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm, and pistachios at 0.2 ppm, and for residues of the metabolite SDS-3701 in or on the following milk and meat commodities: fat of cattle, hogs, goats, horses, and sheep at 0.1 ppm; kidney of cattle, hogs, goats, horses and sheep at 0.5 ppm; meat byproducts (mbyp) (except kidney) of cattle, goats, hogs, horses and sheep at 0.05 ppm and meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and milk at 0.1 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by chlorothalonil, SDS-3701, the major metabolite of chlorothalonil, and hexachlorobenzene (HCB), an impurity in chlorothalonil and other pesticide products, are discussed in the following Table 1 as well as the no observed adverse effect level (NOAEL) and the lowest observed adverse effect level (LOAEL) from the toxicity studies reviewed.

The dose at which no adverse effects are observed (the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern (LOC). However, the lowest dose at which adverse effects of concern are identified (the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor (UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the ariations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. In the case of acute dietary risk, effects were seen at the only dose tested in the subchronic dietary toxicity study in rats; therefore, no NOAEL was identified. Since the LOAEL was used for acute dietary risk assessment, an additional UF of 3X was added to the conventional UF of 100X for a total UF of 300X.-

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

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

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

1. Mechanistic data. In a cell proliferation study, 28 male Fischer 344 rats received technical chlorothalonil (97.9%) in the diet at 175 mg/kg/day for up to 91 days. Mean labeling index was statistically increased in the kidneys of male rats treated with 175 mg/kg/day chlorothalonil at all scheduled sacrifice times. From Day 7 to Day 28, the increase in labeling index was relatively stable (approximately 10-fold over control), with a decrease to approximately 3.5-fold over control on Day 91. Increased cell proliferation correlated with histopathological lesions of degeneration of the proximal convoluted tubules and epithelial hyperplasia. The results of this study demonstrate a sustained cell proliferative response as a result of dietary administration of technical chlorothalonil at a dose of 175 mg/kg/day.

In another study, 96 male SPF rats were divided into test groups of 6 animals per group. Rats received technical chlorothalonil (98.98% a.i.) in the diet at dose levels of 0, 1.5, 15, or 175 mg/kg/day for either 7, 14, 21, or 28 days (total of 24 rats per time point). Histological examination of kidney and stomach tissue was performed for each group after the appropriate exposure. In addition, kidneys were subjected to PCNA staining and stomachs to BrdU staining, and the labeling index and labeling count of cell nuclei were performed. Duodenum was used as a negative control for PCNA and BrdU staining. Increased absolute and relative weight of the kidneys was observed at 175 mg/kg/day at all time points, and, in one animal, at 15 mg/kg/day on Day 28. Increased incidence of vacuolization of the epithelium of the proximal convoluted tubules was observed at all time points at 175 mg/kg/day on Days 7, 14, and 21 at 15 mg/kg/day. PCNA immunostaining of the proximal convoluted tubule epithelial cells showed increased labeling of cells at the 175 mg/kg/day dose level at all time points, and increased labeling at 15 mg/kg/day on Days 7, 14, and 21. BrdU labeling of the rat forestomach showed marked labeling at 175 mg/kg/day at all time points, and increased labeling on Day 28 at 15 mg/kg/day. The results of this study demonstrate a toxic response of the kidney and forestomach to repeated dietary administration of chlorothalonil at doses of 15 and 175 mg/kg/day.

2. Summary of toxicological dose and levels of concern for SDS-3701 for use in human risk assessment. There is no evidence of carcinogenicity for the SDS-3701 metabolite in either rats or mice. For the acute and chronic non-cancer exposure assessments, residues of SDS -3701 were combined with residues of chlorothalonil and the sum compared to chlorothalonil levels of concern (the LOAEL for acute dietary risk and the RfD for chronic non-dietary risk).

3. Summary of toxicological dose and levels of concern for HCB for use in human risk assessment. A summary of the toxicological endpoints for HCB used for human risk assessment is shown in the following Table 3:

-1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.275) for the combined residues of chlorothalonil and its metabolite SDS-3701, in or on a variety of raw agricultural commodities. At levels ranging from 0.05 ppm in cocoa beans and bananas, edible pulp to 15 ppm in celery and papayas. Risk assessments were conducted by EPA to assess dietary exposures from chlorothalonil and its metabolite SDS-3701 in food as follows:

Food uses evaluated in the dietary (food) risk assessments were the published uses of chlorothalonil in 40 CFR 180.275 and pending uses. U.S. Food and Drug Administration monitoring data (1988-1993), USDA Pesticide Data Program (PDP) (1992-1994 partial), and field trial data are types of anticipated residue data provided for chlorothalonil and HCB. Anticipated residues were used for pending tolerances for pistachios (0.068 ppm), mangoes (0.3 ppm), asparagus (0.03 ppm) and non-bell peppers (5 ppm). Percent of crop treated information was used for most crops with established tolerances. Residues of HCB in plant commodities were estimated to be present at 0.05% of the residues of chlorothalonil. This level is equivalent to the maximum level of HCB that is allowed in formulations of chlorothalonil. In meat products, anticipated residues were estimated based on HCB feeding studies.

i. Acute exposure. Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The following assumptions were made for the acute exposure assessments: The computerized modeling system (Dietary Risk Evaluation System (DRES) was used to estimate acute dietary exposure. The analysis evaluates individual food consumption as reported by respondents in the USDA 1977-1978 Nationwide Food Consumption Survey (NFCS) and accumulates exposure to chlorothalonil for each commodity. Each analysis assumes uniform distribution of chlorothalonil in the commodity supply. Acute dietary exposure was estimated based on the theoretical maximum residue contribution (TMRC) or anticipated residues for combined residues of chlorothalonil and SDS-3701.

ii. Chronic exposure.-In conducting this chronic dietary risk assessment the computerized modeling system (Dietary Risk Evaluation System (DRES) was used. The following assumptions were made for the chronic exposure assessments: Tolerance level residues and percent of crop treated information were used in the analysis for chlorothalonil and SDS-3701. Anticipated residues were used in the chronic dietary exposure analysis from food for HCB.

iii. Cancer. In this analysis, dietary exposure from chlorothalonil was estimated based on anticipated residues (excluding meat and milk, eggs and poultry). Meat and milk, eggs and poultry were not included in this analysis since chlorothalonil residues are not expected in these commodities. SDS-3701 was not included in this analysis since it is not carcinogenic. The dietary exposure from food from HCB was estimated based on anticipated residues (includes meat and milk, eggs and poultry). Since HCB is a contaminant in several other pesticides, an aggregate exposure assessment for HCB was conducted with food uses of chlorothalonil, pentachlorobenzene, picloram, and dacthal. HCB is present in five other food-use pesticides but at low levels which do not significantly add to the aggregate dietary exposure. Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has concluded that the carcinogenic potential of PCB is comparable to HCB. In estimating dietary carcinogenic risk from HCB in these four pesticides, the Q* for PCB is assumed to be equal to that for HCB. The assumption was made that the impurities would occur on food commodities at the same ratio to the active ingredient as was present in the formulation applied to these crops. It is also assumed that the impurity would dissipate from the food commodity at an equal or greater rate than the active ingredient. The Agency believes these are reasonable assumptions because there are data from studies with chlorothalonil, picloram and dacthal which support this approach.

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

Section 408(b)(2)(F) states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of percent crop treated (PCT) as required by section 408(b)(2)(F), EPA may require registrants to submit data on PCT. -

The Agency used percent crop treated (PCT) information as described in the following Table 4:

The Agency believes that the three conditions listed above have been met. With respect to Condition 1, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. EPA uses a weighted average PCT for chronic dietary exposure estimates. This weighted average PCT figure is derived by averaging State-level data for a period of up to 10 years, and weighting for the more robust and recent data. A weighted average of the PCT reasonably represents a person's dietary exposure over a lifetime, and is unlikely to underestimate exposure to an individual because of the fact that pesticide use patterns (both regionally and nationally) tend to change continuously over time, such that an individual is unlikely to be exposed to more than the average PCT over a lifetime. For acute dietary exposure estimates, EPA uses an estimated maximum PCT. The exposure estimates resulting from this approach reasonably represent the highest levels to which an individual could be exposed, and are unlikely to underestimate an individual's acute dietary exposure. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which chlorothalonil may be applied in a particular area. -

2. Dietary exposure from drinking water—i. Ground water exposure -chlorothalonil and SDS-3701. Exposure to chlorothalonil in drinking water is derived from the monitoring data. The metabolites of chlorothalonil have been found in ground water in Long Island, New York, and have been attributed to potato use. These metabolites (SDS-46851, SDS-47525, SDS-3701, and SDS-19221) were measured at a combined concentration of approximately 16 parts per billion (ppb) in Suffolk County, Long Island in 1981. Chlorothalonil itself has been detected in the States of California, Florida, Massachusetts, and Maine at levels typically below 1 ppb. These observations are predictable based on laboratory mobility studies and evidence of metabolite persistence. It is expected that the levels of chlorothalonil metabolites detected in the ground water in New York are relatively high compared to the country as a whole, because (a) they were the highest values reported in the database, (b) potatoes are a major crop on Long Island, and (c) Long Island ground water is generally shallow and vulnerable. The Long Island values were used to represent a high-end potential exposure. In the absence of data demonstrating otherwise, this assessment is based on the conservative assumption that the detected metabolites of chlorothalonil have the same toxicity as the parent. As indicated above, this assessment relies on other conservative factors. -

ii. Surface water exposure—chlorothlonil and SDS-3701. Chlorothalonil can contaminate surface water at application via spray drift or after application through runoff and erosion. The intermediate soil/water partitioning of chlorothalonil indicates that its concentration is suspended and bottom sediment will be substantially greater than its concentration in water. The major degradate of chlorothalonil in the soil under aerobic conditions is SDS-3701. SDS-3701 appears to be more persistent and mobile than chlorothalonil, based on ground water detections. Substantial amounts of SDS-3701 could be available for runoff for longer periods than chlorothalonil, and SDS-3701 may be more persistent in water/sediment systems than chlorothalonil. The apparent greater mobility of SDS-3701 suggests that it exhibits lower soil/water partitioning than chlorothalonil. Therefore, the ratio of SDS-3701 runoff loss via dissolution in runoff to runoff loss via adsorption to eroding soil for SDS-3701 may be greater than for chlorothalonil. In addition, the ratios of concentrations dissolved in the water column to concentrations adsorbed to suspended and bottom sediment may be higher for SDS-3701 than for chlorothalonil. The Agency was unable to calculate drinking water risk for SDS-3701 in surface water because no monitoring data were available.

The South Florida Water Management District (SFWMD) summarized chlorothalonil detections in samples collected every 2 to 3 months from 27 surface water sites within the SFWMD from November 1988 through November 1993. Approximately 810 samples (30 sampling intervals × 27 sites sampled/interval) were collected during that time. Chlorothalonil was detected in 25 samples at concentrations ranging from 0.003 ppb to 0.35 ppb. Six of the samples had concentrations ≥0.01 ppb.

-iii. Ground and surface water exposure - HCB and PCB. HCB and pentachlorobenzene are present in ground water and surface water from sources other than current usage of contaminated pesticides, including manufacturer of solvents and tires, incineration of wastes, and coal combustion. HCB and PCB are persistent and relatively immobile in the environment; the major route of dissipation is through sorption to soil, sediment, and suspended particulates in water. HCB and PCB contamination of ground water sources is relatively unlikely due to the high binding potential of both compounds. Detections of HCB in ground water generally have ranged between 0.0002 to 0.100 ppb. Based on monitoring data and fate properties, it seems unlikely that long - term HCB and PCB concentrations in surface water would exceed 10 parts per trillion (ppt) (0.01 ppb).

Surface water detections show much more variability than concentrations in ground water and have been measured at up to 750 ppb. These high values appear to include sorbed HCB. The HCB concentrations which actually appear to be dissolved in the water are generally less than 0.001 ppb. Great Lakes region concentrations generally ranged from 0.00002 to 0.0001 ppb. When concentrations exceeded this range, they appeared to be related to industrial areas or areas of historic contamination (more than 20 years ago). Concentrations of PCB in surface water have ranged between 0.00002 and 0.0001 ppb. Concentrations of HCB and PCB in drinking water can be greatly reduced through treatment with activated granular charcoal. -

Higher concentrations of HCB and PCB have been reported in surface and ground water, but tend to be related to hazardous waste, landfill sites, and suspended sediment. The U.S. Department of Health and Human Services in 1996 estimated that the average exposure in the United States from drinking HCB contaminated water is 0.00085 μg/kg/year (-0.000082 ppb). Since potential exposures are generally so low, and because pesticides are just one source of HCB and PCB in drinking water, the Agency concluded that there are insufficient data to quantify risk and that drinking water risk estimates from HCB in pesticides do not exceed the Agency's level of concern. -

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

Chlorothalonil is currently registered for use on the following residential non-dietary sites: home vegetable gardens, ornamentals, paint, stain, and wood preservatives. The risk assessment was conducted using the following residential exposure assumptions: The Agency completed an exposure assessment for uses of chlorothalonil as an additive containing 40.4% active ingredient for use in caulks, sealants, polymer lattices, grouts, joint compounds, and paper coatings. All relevant occupational and residential exposures were considered. Data were not available to estimate application and post application exposure and risk for primary and secondary homeowner exposure. Primary homeowner exposure occurs in individuals who use or install chlorothalonil-containing material; secondary residential exposure occur when other individuals live and work in places where chlorothalonil-containing materials have been used. For these exposures, no risk assessment could be conducted, but the Agency believes that secondary and homeowner exposures to these products by themselves are generally lower than primary occupational application exposures.

Since other residential risks could not be quantified, risk concerns and uncertainties about exposure resulted in the following agreements with the registrants. To mitigate potential residential exposure concerns and uncertainties about the packaging and concentration of chlorothalonil additives for paint, the registrants have agreed that chlorothalonil mildewicidal additives must be labeled to prohibit sale over-the-counter in retail outlets. The registrants have committed to working with the Agency to develop measures for the protection of employees of paint sales outlets who mix mildewicidal additives into paint for sale. To mitigate potential residential exposure concerns and uncertainties about the in-container preservative use of chlorothalonil, particularly because the chlorothalonil content of products in which the preservative is used may not be known to the purchaser, and because such preservatives may be used in paints intended for use by children, the registrants have agreed that the in-container preservative use of chlorothalonil is prohibited.

The contact rate for activities with ornamentals (5,800 cm2/hr) is based on a study by Brouwer et al., in which chlorothalonil was applied to carnation sprays and carnations grown for cut flowers. Rates for dermal contact with treated turf by adults (1,000 cm2/hr) and toddlers (8,700 cm2/hr) are based on EPA estimates for low exposure activities. Contact rates for hand-to-mouth transfer by toddlers (1.56 events/hour), ingestion of treated grass by toddlers (25 cm2/day), and ingestion of soil from treated areas by children (100 mg/day) are default values which originate with high-end exposure scenarios. For the cancer risk estimates, the Agency assumed that activities with ornamentals occur 4 days per year for 50 years, and that an application is made once a year, for adults in dermal contact with treated turf, that contact occurred 40 days per year for 50 years, and that three applications were made each year. The Agency also assumed that reentry occurred on the day of treatment. -

For residential post-application exposures related to the use of chlorothalonil on turf and ornamentals, short- and intermediate-term MOEs ranged from 14 to 26,000. Only the MOEs for toddlers exposed to treated turf were at a risk level of concern at which the EPA typically takes regulatory action. To address this risk, the registrants have agreed to delete the home lawn use from their manufacturing-use and end-use product labels and have requested voluntary cancellation of their end-use products registered solely for this use. When considering the elimination of the home lawn use of chlorothalonil, EPA had determined that residential post-application exposures to toddlers exposed to treated turf do not exceed EPA's level of concern. -

-A summary of the residential post-application scenarios and cancer risks from chlorothalonil is shown in the following Table 5:

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 chlorothalonil 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, chlorothalonil 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 chlorothalonil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, November 26, 1997).

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

ii. Prenatal and postnatal sensitivity. The developmental and reproductive data for chlorothalonil indicate that there is no evidence of increased sensitivity to chlorothalonil from pre- or post-natal exposures. In the rat developmental toxicity study, the developmental NOAEL and LOAEL were based on an increase in total resorptions per dam with a related increase in post-implantation loss. These observations occurred at a dose (400 mg/kg/day) which produced increased mortality and reduced body weight gain in maternal animals. No developmental toxicity was observed in the rabbit developmental toxicity study, and no maternal toxicity was observed at the highest dose tested (20 mg/kg/day). -

iii. Conclusion. There is a complete toxicity database for chlorothalonil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. EPA determined that the 10X safety factor to protect infants and children should be removed. The FQPA factor is removed because no reproductive effects were observed in any study and developmental effects occurred only in the presence of significant maternal toxicity. HCB was not considered in this evaluation of the special sensitivity of infants and children. HCB will be considered at a future date when the Agency is better equipped to understand the implications of FQPA for HCB, which is a common contaminant of at least nine other pesticides and which also enters the environment from non-pesticidal sources.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the estimated MOEs from exposure to chlorothalonil and SDS-3701 residues from food and water do not exceed the Agency's LOC. A summary of the aggregrate risk assessment for acute exposure to chlorothalonil is shown in the following Table 6:

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to combined residues of chlorothalonil and SDS-3701 from food and water will utilize 34% of the cPAD for the U.S. population, and 68% of the cPAD for children. Based on the use pattern, chronic residential exposure to residues of chlorothalonil is not expected. EPA does not have chronic non-cancer concerns for HCB in chlorothalonil. EPA does not expect the aggregate exposure to exceed 100% of the cPAD.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account residential exposure plus chronic exposure to food and water (considered to be a background exposure level). The estimated MOEs from residential uses ranged from 310 for adults transplanting, pruning or bundling flowers to 110,000 for infants ingesting paint chips. Though residential exposure could occur with the use of chlorothalonil, the potential short- and intermediate-term exposure were not aggregated with chronic food and water exposures because the toxic effects are different. Therefore, based on the best available data and current policies, potential risks do not exceed the Agency's level of concern.

-4. Aggregate cancer risk for U.S. population. HCB and pentachlorobenzene are present in ground water and surface water from sources other than current usage of contaminated pesticides, including manufacturing of solvents and tires, incineration of wastes, and coal combustion. Both are persistent and relatively immobile in the environment; the major route of dissipation is through sorption to soil, sediment, and suspended particulates in water.

HCB and PCB contamination of ground water sources is relatively unlikely due to the high binding potential of both compounds. Detections of HCB in ground water generally have ranged between 0.0002 to 0.100 μg/L. PCB levels in ground water at a hazardous waste site ranged from 0.001 to 62.1 μg/L.

Based on monitoring data and fate properties, its seems unlikely that long-term HCB and PCB concentrations in surface water would exceed 10 ppt (0.01 μg/L). As discussed previously, surface water detections show much more variability than concentrations in ground water but concentrations which actually appear to be dissolved in the water are generally less than 0.001 μg/L.

The upper bound carcinogenic risk from food uses of HCB for the general U.S. population was calculated using the follow equation:

Based on Q* of 1.02 (mg/kg/day)- 1, the upper bound cancer risk was calculated to be 2.4 × 10- 7, contributed through all the published, pending and new uses for chlorothalonil.

The upper bound risk for HCB in chlorothalonil is in the range the Agency generally considers negligible for excess lifetime cancer risk. The exposure assessment for carcinogenic risk from HCB in chlorothalonil includes many assumptions and uncertainties which impact the Agency's confidence in the calculated risk.

HCB is also a contaminant in several other pesticides, and an aggregate risk assessment for HCB from chlorothalonil and these other sources has been conducted. The exposure assessment for aggregate risk is subject to the same kinds of uncertainties and assumptions as the risk assessment for HCB in chlorothalonil. For some of the individual pesticide contributors, these limitations impact the assessment to an even greater extent.

Four pesticides that are used on food/feed crops have been assessed for cancer risk due to contamination with HCB—chlorothalonil, dacthal, picloram, and pentachlornitrobenzene (PCNB). Pentachlorobenzene (PCB) is also present in PCNB, and the Agency has concluded that the carcinogenic potential of PCB is comparable to HCB, based on the similarities of the chemical structures and toxicities of HCB and PCB. In estimating dietary risk from HCB in these four pesticides, the Q* for PCB is assumed to be equal to that for HCB.

HCB is also present in pentachlorophenol, but pentachlorophenol is not a food-use pesticide and so the contaminant in pentachlorophenol does not contribute to aggregate dietary risk (the contribution to drinking water risk is discussed below). HCB and/or PCB is present in five other food-use pesticides, but at low levels which do not significantly add to the aggregate dietary exposure.

The estimated aggregate dietary cancer risk from HCB from all known pesticidal sources is 1.34 × 10- 6. An additional 0.46 × 10- 6 may be attributed to PCB for a total of 1.8 × 10- 6.

A summary of the cancer risks for chlorothalonil, HCB, and PCB are shown in the following Table 7:

-EPA has estimated cancer risk using both the Q* and MOE approaches. Under the MOE approach, cancer risk is estimated at MOE = 9,500. At this point in time, EPA is not able to conclusively determine that chlorothalonil is a non-linear carcinogen nor to apply approved policy determinations on non-linear carcinogens to chlorothalonil, and so cannot determine whether the MOE of 9,500 represents an excess lifetime risk. Under the Q* approach, cancer risk is estimated at 1.2 × 10- 6. This figure is at a level which the EPA considers negligible for excess lifetime cancer risk estimates.

-Cancer risk for HCB is estimated at 2.4 × 10- 7, and EPA does not have cancer risk concerns for chlorothalonil alone. Although subject to considerable uncertainty, cancer risk from HCB from chlorothalonil and other pesticides, combined with cancer risk from the related contaminate PCB present in other pesticides, is estimated at 1.8 × 10- 6, a level at which the EPA typically takes regulatory action. To address this risk, the registrants of chlorothalonil have agreed that the level of HCB in all chlorothalonil products must be reduced to no greater than 0.004% (40 ppm). This is the lowest level that has been shown to be technologically feasible for chlorothalonil. All registrations are conditional on achieving this level, and failure to achieve this level will result in a suspension of manufacture or import of the subject products. In addition, registrants of chlorothalonil products will maintain approximately historic levels of production and import of chlorothalonil manufacuring-use product to assure that chlorothalonil with higher levels of HCB will not be stockpiled and formulated. When this decrease in the amount of HCB is considered, EPA has determined that the cancer risk estimates do not exceed the level for regulatory action.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to combined residues of chlorothalonil and SDS-3701 or from residues of the contaminant HCB.

Adequate enforcement methodology is available in PAM II for non-bell peppers and almonds. Residue analytical methods are available for purposes of reregistration. The Pesticide Analytical Manual (PAM) Vol. II lists Method I, a gas chromatography method with electron capture detection (ECD), for the enforcement of tolerances for plant commodities. Residue data for plant commodities were collected using methods based on the enforcement method. An acceptable enforcement method for residues of SDS-3701 tolerances for peanuts, potatoes, and tomatoes which is a modification of the current enforcement method is available. This method underwent successful validation and is suitable for enforcement of tolerances for SDS-3710 in meat and milk.

There are no Codex, Mexican or Canadian MRLs for almonds, almond hulls, asparagus, mango, and pistachio.

All data pertaining to rotational crops have been evaluated and deemed adequate. In response to Agency evaluations of confined rotational crop data, there is a 12-month rotational crop restriction on all pertinent product labels. Available data indicate that only residue that was detected in rotated crops was the soil metabolite (SDS-46851). Because of the low toxicity of this metabolite, an exemption for the requirement of a tolerance for residues of the soil metabolite 2-carbamyl-2,4,5-trichlorobenzoic acid (SDS-46851) as inadvertent residues in rotated crops has been established (40 CFR 180.110).

Therefore, tolerances are established for combined residues of chlorothalonil, chlorothalonil and its metabolite SDS-3701, in or on almonds (nutmeats) at 0.05 ppm, almond hulls at 1.0 ppm, asparagus at 0.1 ppm, mangoes at 1.0 ppm, non-bell peppers at 5 ppm, and pistachios at 0.2 ppm, and for residues of the metabolite, 4-hydroxy-2,5,6 trichloroisopthalonitrile (SDS-3701), in or on the following milk and meat commodities: fat of cattle, hogs, goats, horses, and sheep at 0.1 ppm,; kidney of cattle, hogs, goats, horses and sheep at 0.5 ppm; mbyp (except kidney) of cattle, goats, hogs, horses and sheep at 0.05 ppm, meat of cattle, goats, hogs, horses, and sheep at 0.03 ppm and milk at 0.1 ppm.

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

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket control number OPP-301088 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 May 11, 2001.

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

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

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

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

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

3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI.A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I.B.2. Mail your copies, identified by docket control number OPP-301088, to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. In person or by courier, bring a copy to the location of the PIRIB described in Unit I.B.2. You may also send an electronic copy of your request via e-mail to: opp-docket@epa.gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

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

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

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

NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for the Groundfish Fishery of the Bering Sea and Aleutian Islands Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2001 A season Atka mackerel total allowable catch (TAC) in the Western Aleutian District of the BSAI is 12,904 metric tons (mt) as established by the Final 2001 Harvest Specifications and Associated Management Measures for the Groundfish Fisheries Off Alaska (66 FR 7276, January 22, 2001).

In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2001 A season Atka mackerel TAC in the Western Aleutian District will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 12,654 mt, and is setting aside the remaining 250 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance soon will be reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the Western Aleutian District of the BSAI.

Maximum retainable bycatch amounts may be found in the regulations at § 679.20(e) and (f).

On February 13, 2001, NMFS prohibited trawling within Steller sea lion critical habitat in the Western Aleutian District because the allowable harvest of Atka mackerel in the Steller Sea lion protection areas in the Western Aleutian District had been reached (66 FR 10637, February 16, 2001). Regulations at 679.22(a)(12)(iii)(C) authorize opening Steller sea lion critical habitat in the Western Aleutian District to fishing with trawl gear after NMFS closes Atka mackerel to directed fishing within that district. NMFS, therefore, announces that the above mentioned, previously closed areas of the Steller Sea lion critical habitat in the Western Aleutian District are open to fishing with trawl gear for species in areas open to directed fishing. This action does not open critical habitat areas that are closed to transiting or fishing with trawl gear year round.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, finds that the need to immediately implement this action to prevent exceeding the amount of the 2001 A season harvest specification of Atka mackerel in the Western Aleutian District of the BSAI constitutes good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(3)(B) and 50 CFR 679.20(b)(3)(iii)(A), as such procedures would be unnecessary and contrary to the public interest. Similarly, the need to implement these measures in a timely fashion to prevent exceeding the 2001 A season harvest specification of Atka mackerel in the Western Aleutian District of the BSAI constitutes good cause to find that the effective date of this action cannot be delayed for 30 days. Accordingly, under 5 U.S.C. 553(d), a delay in the effective date is hereby waived.

This action is required by §§ 679.20 and 679.22 and is exempt from review under Executive Order 12866.