Examining the Docket

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 747-400, 747-400D, and 747-400F series airplanes. That NPRM was published in the Federal Register on September 15, 2005 (70 FR 54484). That NPRM proposed to require repetitive detailed inspections for damage (degraded finish; missing, lifted, peeling, or blistering paint; or signs of corrosion) of the interior skin in the forward and aft cargo compartments, and corrective actions if necessary.

We provided the public the opportunity to participate in the development of this AD. We received no comments on the NPRM or on the determination of the cost to the public.

We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data and determined that air safety and the public interest require adopting the AD with the change described previously. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 260 airplanes of the affected design in the worldwide fleet. The following table provides the estimated costs for U.S. operators to comply with this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 777-200 and -300 series airplanes. That NPRM was published in the Federal Register on June 3, 2005 (70 FR 32524). That NPRM proposed to require repetitive detailed inspections of the forward lugs of the power control unit (PCU), yoke assembly, and forward attachment hardware of the left inboard, left outboard, right inboard, and right outboard flaperon PCUs; and other specified/corrective actions if necessary. For certain airplanes, the NPRM also proposed to require other related concurrent actions.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

Two commenters request that we revise the compliance times of the initial and repetitive inspections for Model 777-200 and -300 series airplanes powered by Rolls-Royce engines. Both commenters state that the initial inspection in the third row of Table 1 of the NPRM should be specified in flight hours. One commenter, the airplane manufacturer, states that the repetitive inspections in the second and third rows of Table 1 of the NPRM should also be specified in flight hours. The commenters point out that these revisions are consistent with what is recommended in Boeing Service Bulletin 777-27A0056, Revision 1, dated July 8, 2004.

We agree . We did not intend to differ from the compliance time recommended in the service bulletin. Therefore, we have revised the compliance times of the initial inspection in the third row of Table 1 of this AD and the repetitive inspection interval in the second and third rows of Table 1 of this AD.

One commenter requests that we clarify when the compliance time clock starts for the initial inspections of the Model 777-200 and -300 series airplanes powered by Rolls-Royce engines. These compliance times are listed in rows 2 and 3, of the second column of Table 1 of the NPRM. The commenter states that, according to Boeing Service Bulletin 777-27A0056, Revision 1, the clock for measuring flight cycles and flight hours should start from the date of airplane delivery. The commenter asserts that compliance times as written in the NPRM do not clearly state that.

We agree. We have revised the compliance times in rows 1, 2, and 3, of the second column of Table 1 of this AD to specify that the threshold of the initial inspection should be measured from “* * * the date of issuance of the original standard airworthiness certificate or the date of issuance of the original export certificate of airworthiness.”

One commenter, the manufacturer, requests that we make the following changes to Table 1 of the NPRM:

• In row 1 of the first column, add L/Ns 1 through 297 inclusive for Model 777-200 and -300 airplanes powered by General Electric or Pratt & Whitney engines.

• In row 2 of the first column, add L/Ns 1 through 297 inclusive for Model 777-200 and -300 airplanes powered by Rolls-Royce engines.

• In row 3 of the first column, add L/Ns 298 and subsequent for Model 777-200 and -300 airplanes powered by Rolls-Royce engines.

• In row 2 of the second column, add the phrase “* * * date of this AD, whichever is later.”

For clarification we agree to add “L/Ns 1 through 297 inclusive” to row 1 of the first column of Table 1 of this AD. We have verified that the commenter's other proposed changes were included in the NPRM, as published in the Federal Register on June 3, 2005. That information is retained in this AD, so no additional change to this AD is necessary in this regard.

One commenter requests that, for the proposed initial and repetitive inspections, we clarify whether the applicable airplanes are powered by General Electric, Pratt & Whitney, or Rolls-Royce engines. The commenter states that Boeing Service Bulletin 777-27A0056, Revision 1, identifies the applicable airplanes as Group 1, 2, or 3 airplanes with the inspection details.

We agree. We have revised Table 1 of this AD to identify the affected airplanes as Group 1, 2, or 3 airplanes, in addition to including the line numbers and engine types. With the changes discussed previously, this information is consistent with what is specified in the effectivity of Boeing Service Bulletin 777-27A0056, Revision 1.

One commenter requests that we delete the last sentence of paragraph (f) of the NPRM: “Do the applicable corrective actions before further flight.” The commenter states that this sentence conflicts with the compliance times in Table 1 of the NPRM.

We do not agree to delete the sentence. Table 1 of this AD specifies compliance times for doing the initial and repetitive inspections. The last sentence of paragraph (f) of this AD specifies the compliance time for doing the corrective actions if, during any inspection, any damage to the attachment hardware, PCU lug, or yoke assembly is found, or a migrated or rotated bearing is found. We defined these corrective actions in the “Relevant Service Information” paragraph of the NPRM. These corrective actions must be done before further flight after finding damage.

We inadvertently omitted the compliance time for the other specified action, which is tightening the attachment bolts to a higher torque value. The other specified action must also be done before further flight after accomplishing the inspections specified in paragraphs (f)(1) through (f)(5) of this AD. Therefore, we have added that action to the last sentence of paragraph (f) of this AD.

One commenter requests that we delete reference to Boeing Service Bulletin 777-27-0049, dated August 30, 2001, from paragraph (h) of the NPRM, and add it to paragraph (g) of the NPRM. As justification, the commenter states that Boeing Service Bulletin 777-27A0056, Revision 1, recommends accomplishing both Boeing Service Bulletin 777-27-0009, Revision 1, dated May 8, 2003, and Boeing Service Bulletin 777-27-0049 concurrently with Boeing Service Bulletin 777-27A0056, Revision 1.

We disagree. As we stated in the difference paragraph of the NPRM, this AD does not require concurrent accomplishment of Boeing Service Bulletin 777-27-0049. Instead, paragraph (g) of this AD requires concurrent accomplishment of Boeing Service Bulletin 777-27-0009, Revision 1, with the exception to install new, improved steel yoke assemblies having improved bearing retention, part number (P/N) 251W1130-3. We have determined that installing P/N 251W1130-3 concurrently with doing the detailed inspections of the forward lugs of the PCU and of the attachment hardware for damage (required by paragraphs (f)(1) and (f)(5) of this AD), in accordance with Boeing Service Bulletin 777-27A0056, Revision 1, adequately addresses the concurrent requirements identified in Boeing Service Bulletin 777-27-0049. Therefore, no change to this AD is necessary in this regard.

One commenter requests that we revise paragraph (h) of the NPRM to give credit to Group 1 airplanes for the inspections specified in paragraphs (f)(1) through (f)(5) of the NPRM. The commenter points out that Note 3 in the Accomplishment Instructions of Boeing Service Bulletin 777-27A0056, Revision 1, states that Group 1 airplanes have accomplished the intent of that service bulletin if those airplanes have incorporated the modification in Boeing Service Bulletin 777-27-0049 and tightened the PCU attach bolts to the higher torque values given in Boeing Service Bulletin 777-27A0056, Revision 1. The commenter has accomplished the actions specified in Boeing Service Bulletin 777-27-0049 and has tightened the bolts in accordance with Boeing Service Letter 777-SL-27-030, dated January 4, 2001. The commenter asserts that these actions should terminate the proposed inspections for Group 1 airplanes.

We disagree. Boeing Service Bulletin 777-27-0049 does not specify doing a detailed inspection of the aft lugs of the yoke assembly for fretting damage, which is required by paragraph (f)(2) of this AD. In addition, we must ensure that the inspections specified in paragraphs (f)(1) through (f)(5) of this AD are accomplished concurrently with tightening the attachment bolts to a higher torque value (the other specified action required by paragraph (f) of this AD). Operators, who installed the new, improved yoke assembly having improved bearing retention, P/N 251W1130-3, but tightened the attachment bolts to the lower torque values specified in the Boeing 777 Airplane Maintenance Manual, have reported finding loose or fretted bolts, and at least one fractured bolt, with significant damage to the yoke and PCU. However, under the provisions of paragraph (k) of this AD, we may consider requests for approval of an alternative method of compliance if sufficient data are submitted to substantiate that such method would provide an acceptable level of safety.

One commenter requests that we revise paragraph (h) of the NPRM to identify the applicable airplanes by group numbers for terminating certain inspections. The commenter states that accomplishing Boeing Service Bulletin 777-27-0049 on Group 1 airplanes terminates the inspections specified in paragraphs (f)(1) through (f)(5) of the NPRM. The commenter also states that accomplishing Boeing Service Bulletin 777-27-0049 on Group 2 and 3 airplanes terminates the inspections specified in paragraphs (f)(3) and (f)(4) of the NPRM.

We disagree. As discussed in the previous comment, we have determined that, for Group 1 airplanes, accomplishing the actions in Boeing Service Bulletin 777-27-0049 terminates only the inspections required by paragraphs (f)(3) and (f)(4) of this AD. Consequently, we do not need to distinguish between airplane groups in this regard. In addition, the effectivity of Boeing Service Bulletin 777-27-0049 is different than the effectivity of Boeing Service Bulletin 777-27A0056, Revision 1. Therefore, paragraph (h) of this AD is only applicable to the airplanes identified in the effectivity of Boeing Service Bulletin 777-27-0049. No change is necessary to this AD in this regard.

One commenter requests that we revise the last sentence of the difference paragraph in the NPRM. The commenter asserts that the paragraph should state that accomplishing Boeing Service Bulletin 777-27-0049 is an optional terminating action for certain repetitive inspections “ * * * on certain Model 777-200 and -300 series airplanes.”

We do not agree to add the additional phrase. Although we agree that the commenter's statement is true, we do not publish difference paragraphs in a final rule. In addition, no change is needed to paragraph (h) of this AD in this regard, since that paragraph identifies the certain Model 777-200 and -300 series airplanes that are allowed credit for the optional terminating action.

One commenter, an operator, states that the cost impact of the proposed inspections for its fleet is $34,820, per inspection cycle. The commenter states it has completed the proposed inspections on 35 of 45 of its affected airplanes. The commenter has based the cost impact on a figure of 8.5 man-hours to complete the proposed inspection. We infer the commenter would like us to revise the “Costs of Compliance” section of this AD.

We disagree. The estimated work hours in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. In this case, we agree with the manufacturer's estimate; Boeing Service Bulletin 777-27A0056, Revision 1, estimates 4 man-hours to do the inspection. Therefore, no change is necessary to this AD in this regard.

We have revised the “Alternative Methods of Compliance (AMOCs)” paragraph in this AD to clarify the delegation authority for Authorized Representatives for the Boeing Commercial Airplanes Delegation Option Authorization.

We have also revised this AD to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 483 airplanes of the affected design in the worldwide fleet. This AD affects about 131 airplanes of U.S. registry. The inspections take about 4 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of the inspections for U.S. operators is $34,060, or $260 per airplane, per inspection cycle.

The concurrent actions of Boeing Service Bulletin 777-27-0009, if required, take about 7 work hours per airplane. Required parts cost about $12,758 per airplane. Based on these figures, the estimated cost of these concurrent actions is $13,213 per airplane.

The concurrent actions of Boeing Service Bulletin 777-27-0049, if required, take about 5 work hours per airplane. Required parts cost about $3,245 per airplane. Based on these figures, the estimated cost of these concurrent actions is $3,570 per airplane.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 767-200, -300, and -300F series airplanes. That NPRM was published in the Federal Register on July 6, 2005 (70 FR 38819). That NPRM proposed to require replacing the aileron control override quadrant with a modified unit.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

Two commenters express support for the proposed AD.

One commenter, an airplane operator, requests that the proposed compliance time for replacing the aileron control override quadrant be extended from 18 months after the effective date of the AD to 21 months after the effective date of the AD. The commenter states that the 18-month compliance time will create undue economic hardship because it's “C” check interval has been extended to 21 months.

We do not agree with the commenter's request to extend the compliance time. In developing an appropriate compliance time for this action we considered the urgency associated with the subject unsafe condition, and the practical aspect of accomplishing the required modification within a period of time that corresponds to the normal scheduled maintenance for most affected operators. Since maintenance schedules vary from operator to operator, it is not possible to guarantee that all affected airplanes could be modified during scheduled maintenance, even if we extended the compliance time to 21 months. We find that an 18-month compliance time represents the maximum time in which the affected airplanes may continue to operate without compromising safety. We also note that economic hardship is not sufficient rationale for demonstrating that an extended compliance time would provide an acceptable level of safety. However, according to the provisions of paragraph (h) of the final rule, we may approve requests to adjust the compliance time if the request includes data to substantiate that the new compliance time would provide an acceptable level of safety. No change to the final rule is necessary.

One commenter notes that the “Relevant Service Information” section of the proposed AD should be corrected to state that Revision 1 of Boeing Alert Service Bulletin 767-27A0175, dated June 3, 2004, increased the effectivity rather than Revision 2, of Boeing Service Bulletin 767-27A0175, dated August 5, 2004, as is currently stated in that section. The commenter points out that Revision 1 of the alert service bulletin increased the applicability and that this applicability was continued in Revision 2 of the service bulletin.

We partially agree with the commenter. We agree that the additional airplanes (line number 837 through 918) were added to Revision 1 rather than Revision 2 of the service bulletin, and we have revised paragraphs (f) and (i) of the final rule accordingly. However, since the “Relevant Service Information” section of the preamble does not reappear in the final rule, we have not revised that section.

One commenter disagrees with the projected costs to accomplish the proposed replacement of the aileron control override quadrant. The commenter states that its actual costs to do the replacement have been $1,068 per airplane rather than $796, which was the cost proposed in the NPRM.

We infer that the commenter would like the cost estimate to be revised to closer reflect its actual costs. We acknowledge the commenter's concerns, but disagree with revising the cost estimate. Although the operator has tracked its own costs based on data it kept when accomplishing related AD 2003-15-03, amendment 39-13245 (68 FR 44197, July 28, 2003), the commenter does not state how the additional costs were accrued (e.g., additional labor, parts, etc.). We acknowledge that the costs associated with doing the required actions can vary depending on if the operator chooses to replace the existing override quadrant assembly, or if it chooses to overhaul the existing override quadrant by installing new corrosion resistant steel bearings. In addition, we recognize that in accomplishing the requirements of any AD, operators may incur “incidental” costs in addition to the “direct” costs that are reflected in the cost analysis presented in the AD preamble. However, the cost analysis in AD rulemaking actions typically does not include incidental costs, but only the costs of the specific actions required by the AD action.

We have not revised the final rule in this regard.

We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have revised the cost estimate to correct the number of airplanes in the worldwide fleet. The NPRM stated that the number is 127 airplanes; the final rule states that the number is 82 airplanes.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 82 airplanes of the affected design in the worldwide fleet. This proposed AD affects about 45 airplanes of U.S. registry. The actions will take about 10 work hours per airplane, at an average labor rate of $65 per work hour. Required parts cost about $146 per airplane. Based on these figures, the estimated cost of this AD for U.S. operators is $35,820, or $796 per airplane.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

You may examine the airworthiness directive (AD) docket on the Internet at http://dms.dot.gov or in person at the Docket Management Facility office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The Docket Management Facility office (telephone (800) 647-5227) is located on the plaza level of the Nassif Building at the street address stated in the ADDRESSES section.

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to certain Boeing Model 737-100, -200, -200C, -300, -400, -500, -600, -700, -700C, -800 and -900 series airplanes. That NPRM was published in the Federal Register on July 5, 2005 (70 FR 38630). That NPRM proposed to require modifying the elevator input torque tube assembly.

We provided the public the opportunity to participate in the development of this AD. We have considered the comments received.

One commenter states that although the proposed AD does not affect any airplane in its fleet, it supports the actions in the AD.

The airplane manufacturer requests that we revise the third sentence in the Summary section of the proposed AD from, “This proposed AD is prompted by a report of a restriction in the pilot's elevator control system,” to “This proposed AD is prompted by the results of a design review performed on the input torque tube assembly, which discovered possible failure modes that could lead to a jam of the elevator control system.” The commenter explains that the sentence, as proposed, may be misleading by connecting the pilots' reported condition to the hypothetical jam that is addressed by the proposed AD.

We partially agree with the commenter. We agree that the wording in the Summary section could lead to an interpretation that the cause of the reported incident was restrictions in the pilot's elevator input control system. We disagree with revising the section as proposed, because, as stated in the Discussion section of the proposed AD, the design review was conducted as part of an intensive investigation. The investigation was conducted by the National Transportation Safety Board, the FAA, and Boeing. We have revised the Summary section and paragraph (d) of the final rule to state, “This AD results from a report of a restriction in the pilot's elevator input control system. A design review performed on the elevator input torque tube assembly in the course of the investigation discovered possible failure modes that could lead to a jam of the elevator control system.”

The commenter, an airplane operator, requests that paragraph (f) be revised to allow alternate methods for re-identifying the modified elevator torque tube assemblies. The commenter explains that the service bulletins referenced in the proposed AD specify the use of a rubber ink stamp method to re-identify the modified assemblies. The commenter points out that operators of a single airplane would have to fabricate or acquire a stamp for a one-time use, and operators of many airplanes would have to acquire dozens of rubber stamps to support the various overhaul facility locations. The commenter requests that the final rule allow for use of either the rubber stamp method, or the use of a pen with indelible ink. The commenter states that the component number could then be covered with protective covering.

We agree with the commenter. The intent of the procedures in the proposed AD and in the service bulletins is to signify that the modification has been accomplished, not to specify the method of re-identification. We have revised paragraph (f) of the final rule to allow alternate permanent part marking in lieu of rubber stamping.

We have revised this action to clarify the appropriate procedure for notifying the principal inspector before using any approved AMOC on any airplane to which the AMOC applies.

We have carefully reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the changes described previously. We have determined that these changes will neither increase the economic burden on any operator nor increase the scope of the AD.

There are about 2,971 airplanes of the affected design in the worldwide fleet. This AD will affect about 1,573 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.

In addition, a special tool is necessary to do the modification required by this AD. Boeing will provide one tool at no charge to each customer regardless of warranty status.

Based on these figures, the estimated total cost of this AD for U.S. operators is about $1,046,354, or between $1,271 and $1,990 per airplane.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in subtitle VII, part A, subpart III, section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We have determined that this AD will not have federalism implications under Executive Order 13132. This AD 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.

For the reasons discussed above, I certify that this AD:

(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.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket. See the ADDRESSES section for a location to examine the regulatory evaluation.

Our current regulations at 20 CFR 422.103(e), Replacement of social security number card, state that :

• In the case of lost or damaged SSN card, a duplicate card bearing the same name and number may be issued, and

• In the case of a need to change the name on the card, a corrected card bearing the same number and the new name may be issued.

Furthermore, our regulations at 20 CFR 422.110(a) currently state that an individual who wishes to change his or her name or other personal identifying information must prove his or her identity and may be required to provide other evidence. If a completed request and all applicable evidence are received for a change in name, a new SSN card with the new name and bearing the same number previously assigned will be issued to the person making the request.

Our current regulations do not put any numerical limits on the number of replacement SSN cards an individual may obtain. Prior to the new statutory replacement SSN card limit, the only limitation on the number of cards has been a protocol in our electronic records that prevents the issuance of a replacement SSN card within seven days of a previous issuance.

Section 7213(a)(1)(A) of Public Law 108-458 (the Intelligence Reform and Terrorism Prevention Act of 2004), enacted on December 17, 2004, requires that we restrict the issuance of multiple replacement SSN cards to any individual to three replacement SSN cards per year and ten replacement cards for the life of the individual. The statute mandates enforcement of the limits not later than one year after December 17, 2004. In applying these limits, we will not consider replacement social security number cards issued prior to December 17, 2005. The provision also states that we may allow for reasonable exceptions from the limits on a case-by-case basis in compelling circumstances. In order to comply with this provision of Public Law 108-458, we are revising §§ 422.103 and 422.110 of our regulations.

We are also making nonsubstantive changes to § 422.107 to streamline the wording in this section.

We are revising § 422.103(e) of our regulations by restricting the number of replacement cards an individual may obtain both during a year and over a lifetime. These limits are set at three replacement SSN cards in a year and ten per lifetime. However, as permitted by section 7213(a)(1)(A) of Public Law 108-458, we may allow for reasonable exceptions to these limits on a case-by-case basis in compelling circumstances. We are allowing exceptions for name changes ( i.e. , verified changes to first name and/or surname) and for changes in alien status that result in a necessary change to a restrictive legend on the SSN card, because we believe these situations satisfy the compelling circumstances test. We want to ensure the accuracy of our records by encouraging number holders to report name changes and changes in alien status. Consequently, every change in name or alien status, where the restrictive legend must change, presents compelling circumstances for not applying the replacement card limits. Since we investigate the validity of documents submitted when individuals change their name or alien status (see 20 CFR 422.107(c) and (e)), we believe these are reasonable exceptions to the limitations in light of our compelling need for accurate records. Therefore, we will not count toward the annual and lifetime limits those SSN replacement cards for name and restrictive legend changes. We will grant an exception to the limits on a case-by-case basis if the individual provides evidence of hardship, such as a referral letter from a governmental social services agency indicating that the SSN card must be shown in order to obtain benefits or services. Finally, in an effort to streamline our definition of a replacement SSN card, we are eliminating language regarding the sub-categories of duplicate and corrected SSN cards from the language heretofore incorporated in this regulation.

To conform to the changes we are proposing in § 422.103 regarding streamlining the definition of a replacement SSN card, we are replacing the words “duplicate” or “corrected” with “replacement” in paragraphs (a) through (e) and (g) of this section.

We are revising § 422.110 to add cross-references to new paragraph (e)(2) in § 422.103, which describes the new limits on replacement SSN cards and the exceptions to those limits. We are making a minor revision to paragraph (b) to reflect that the Immigration and Naturalization Service has been abolished and its functions and units incorporated into the Department of Homeland Security. We have also made other clarifying language changes.

We anticipate that the three-card per year limit will impact fewer than 10,000 individuals in any given year. For example, of the nearly 12.4 million replacement SSN cards we issued in 2004, the number of individuals who requested more than three replacement cards was 3,818. However, we do not have any data available for those individuals who requested replacement cards exceeding the ten-card per lifetime limit. These changes will be effective prospectively, and we will not consider replacement SSN cards that were issued prior to the rule change when applying either limit.

Executive Order 12866, as amended by Executive Order 13258, requires each agency to write all rules in plain language. In addition to your substantive comments on these rules, we invite your comments on how to make these rules easier to understand. For example:

• Have we organized the material to suit your needs?

• Are the requirements in the rules clearly stated?

• Do the rules contain technical language or jargon that is unclear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rules easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists or diagrams?

• What else could we do to make the rules easier to understand?

Pursuant to section 702(a)(5) of the Act, 42 U.S.C. 902(a)(5), as amended by section 102 of Public Law 103-296, SSA follows the Administrative Procedure Act (APA) rulemaking procedures specified in 5 U.S.C. 553 in the development of its regulations. The APA provides exceptions to its Notice of Proposed Rulemaking (NPRM) procedures when an agency finds there is good cause for dispensing with such procedures on the basis that they are impracticable, unnecessary, or contrary to the public interest.

In the case of these rules, we have determined that, under 5 U.S.C. 553(b)(B), good cause exists for dispensing with the notice and public comment procedures. Application of the notice and comment provisions is impracticable because section 7213(a)(1)(A) of Public Law 108-458 must be implemented no later than December 17, 2005 . In addition, section 7213(a)(1)(A) serves important anti-terrorism and fraud prevention goals, which would be frustrated by any implementation delays. Thus, the public interest will be best served by immediate implementation of section 7213(a)(1)(A), which will deter and prevent SSN misuse and fraud.

In addition, we find good cause for dispensing with the 30-day delay in the effective date of a substantive rule, provided for by 5 U.S.C. 553(d). As explained above, SSA is responding to the public need to deter and prevent SSN misuse and fraud under the requirements of the IRTPA. Therefore, we find that it is in the public interest to make these rules effective upon publication, with a request for comments so that the rules can be revised as necessary or appropriate after public review. We intend to publish final rules within 120 days of the close of the comment period.

We have consulted with the Office of Management and Budget (OMB) and determined that these final rules meet the criteria for a significant regulatory action under Executive Order 12866, as amended by Executive Order 13258. Thus, the rules have been reviewed by OMB.

We certify that these rules would not have a significant economic impact on a substantial number of small entities because they would affect only individuals. Thus, a regulatory flexibility analysis as provided in the Regulatory Flexibility Act, as amended, is not required.

These rules contain reporting requirements as shown in the following table. Where the public reporting burden is accounted for in Information Collection Requests for the various forms that the public uses to submit the information to SSA, a 1-hour placeholder burden is being assigned to the specific reporting requirement(s) contained in these rules; we are seeking clearance of these burdens because they were not considered during the clearance of the forms.

An Information Collection Request has been submitted to the Office of Management and Budget (OMB) for clearance. We are soliciting comments on the burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and on ways to minimize the burden on respondents, including the use of automated collection techniques or other forms of information technology. Comments should be submitted and/or faxed to OMB at the following address/number: Office of Management and Budget, Attn: Desk Officer for SSA, Fax Number: 202-395-6974.

Social Security Administration, Attn: SSA Reports Clearance Officer, Rm. 1338 Annex Building, 6401 Security Boulevard, Baltimore, MD 21235-6401,Fax Number: 410-965-6400.

We will accept comments for 60 days after this notice is published, but comments would be most useful if we receive them within 30 days. To receive a copy of the OMB clearance package, you may call the SSA Reports Clearance Officer on 410-965-0454.

The following sponsors have requested that FDA withdraw approval of the 15 NADAs listed in table 1 of this document because the products are no longer manufactured or marketed:

Following the withdrawal of approval of these NADAs, Kerber Milling Co., M & M Livestock Products Co., Nutra-Blend Corp., and South St. Paul Feeds, Inc., are no longer sponsors of an approved application. Therefore, we are removing entries for these four sponsors from 21 CFR 510.600(c).

As provided below, the animal drug regulations are amended to reflect the withdrawal of approvals.

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.

DEA is the primary agency responsible for implementing the provisions of the federal Controlled Substances Act and the Controlled Substances Import and Export Act (21 U.S.C. 801-971) (CSA). DEA publishes the implementing regulations for the CSA in Title 21 of the Code of Federal Regulations (CFR), §§ 1300.01 to 1316.99. The statutory scheme is designed to ensure that there is a sufficient supply of controlled substances for legitimate medical purposes and deter the diversion of controlled substances for illegal purposes. The CSA mandates that DEA establish a closed system of control for manufacturing, distributing, and dispensing controlled substances. Any person who manufactures, distributes, dispenses, imports, exports, or conducts research or chemical analysis with controlled substances must register with DEA (unless exempt) and comply with the applicable CSA requirements for the activity.

Drugs controlled under the CSA include opiates, hallucinogens and central nervous system stimulants and depressants. In addition, as a result of the passage of the Anabolic Steroid Control Act of 1990, anabolic steroids, as a class of drugs, were placed under the CSA effective February 27, 1991.

On October 22, 2004, the President signed into law the Anabolic Steroid Control Act of 2004, Public Law 108-358 (118 Stat. 1661). Section 2(a) amended the Controlled Substances Act (21 U.S.C. 802) by replacing the existing definition of “anabolic steroid” with a new definition for use in the future to administratively classify new steroids as Schedule III anabolic steroids. In addition, the Act listed 59 specific substances as being Schedule III anabolic steroids. Ethers of these listed steroids were also, for the first time, controlled in Schedule III, while the isomers of these steroids were removed from Schedule III controls. Additionally, section 2(b) amended the Controlled Substances Act (21 U.S.C. 811(g)) by revising the language excluding certain over the counter products from regulation as controlled substances. The statute is self-implementing with changes that became effective January 20, 2005.

DEA is promulgating this rule as a final rule rather than a proposed rule because the changes are being made to correspond to statutory revisions. DEA has no authority to revise the changes and is simply amending its regulations to conform to the statute. Since DEA could not revise the rule based on public comments, DEA finds that notice and opportunity for public comment are unnecessary under the Administrative Procedure Act, 5 U.S.C. 553(b)(B).

Congress enacted the Anabolic Steroid Control Act of 2004, Public Law 108-358 (118 Stat. 1661), which the President signed on October 22, 2004. The House Report (108-461) stated that the purpose of the Act is “to prevent the abuse of steroids by professional athletes. It will also address the widespread use of steroids and steroid precursors by college, high school, and even middle school students.” The House Report also noted that steroid precursors “are as dangerous to the body as those banned under the original Act.”

The Act does two things of relevance to this rulemaking. It replaces the existing definition of “anabolic steroid” in 21 U.S.C. 802 and revises the language exempting certain over the counter products from regulation as controlled substances. The changes to the definition include the following:

• Elimination of the need to prove that a steroid promotes muscle growth in order to administratively place the steroid into Schedule III of the CSA.

• Correction of the listing of steroid names resulting from the passage of the Anabolic Steroid Control Act of 1990.

• Replacement of the list of 23 steroids with a list of 59 steroids, including both intrinsically active steroids as well as steroid metabolic precursors.

• Automatic scheduling of the salts, esters and ethers of Schedule III anabolic steroids without the need to prove that these salts, esters or ethers promote muscle growth.

• Removal of the automatic scheduling of isomers of steroids listed as Schedule III anabolic steroids.

• Addition of dehydroepiandrosterone (DHEA) to the list of excluded substances.

In addition to revising the definition of anabolic steroid, the Act also amends the CSA by revising the language requiring exclusion of certain over the counter products from regulation as controlled substances. The Act clarifies that the exclusionary language in 21 U.S.C. 811 (g)(1) pertains only to nonnarcotic “drugs” that may, under the Federal Food, Drug, and Cosmetic Act (FDCA), be lawfully sold over the counter without a prescription.

Congress modified 21 U.S.C. 811(g) by changing the language in paragraphs (1) and (3). Paragraph (g)(1) previously read:

The revised paragraph reads:

The change from “substance” to “drug” clarifies that only those over the counter (OTC) non-narcotic products containing controlled substances that are regulated as drugs under the Federal Food, Drug, and Cosmetic Act (FDCA) will be excluded from CSA regulatory requirements. Many of these steroids have previously been marketed as dietary supplements. Such dietary supplements (which are subject to requirements implemented pursuant to the Dietary Supplement Health and Education Act of 1994) are subject to different regulatory requirements than OTC non-prescription drugs under FDCA provisions.

This statutory change serves to clarify this distinction. The exclusion provided under 21 U.S.C. 811(g)(1) pertains only to nonnarcotic “drugs” that may, under the FDCA, be lawfully sold over the counter without a prescription.

The second revision to paragraph (g) specifies that the Attorney General may exclude by regulation, any compound, mixture, or preparation containing an anabolic steroid and which is intended for administration to a human being or animal, if the Secretary of Health and Human Services recommends the exemption because its concentration, preparation, formulation, or delivery system means it does not present any significant potential for abuse. DEA has already incorporated this provision in its regulations (21 CFR 1308.33). In contrast, DEA can, without seeking a recommendation from the Secretary of Health and Human Services, exempt any chemical preparation or mixture containing a controlled substance which is not intended for human or veterinary use and which is determined not to have a significant abuse potential because of its concentration, preparation or formulation. This latter provision is incorporated into 21 CFR 1308.23.

The impact of the revisions is to make all of the listed steroids and any of their salts, esters, or ethers, Schedule III controlled substances and subject to CSA requirements. Any person who manufactures, distributes, dispenses, imports or exports a substance defined as an anabolic steroid or who engages in research or conducts instructional activities with respect to substances defined as anabolic steroids must obtain a Schedule III registration in accordance with the CSA and its implementing regulations. Manufacturers and importers of the listed steroids must register with DEA and are permitted to distribute the steroids only to other DEA registrants. Only persons registered as dispensers are allowed to dispense the steroids to end users. Registered dispensers, however, are limited to practitioners, who are defined in the CSA as physicians, dentists, veterinarians, scientific investigators, pharmacies, hospitals, or other persons licensed, registered, or otherwise permitted by the U.S. or the jurisdiction in which they practice or conduct research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research, 21 U.S.C. 802(21).

As of January 20, 2005, manufacture, import, export, distribution, or sale of the listed steroids except by DEA registrants has been a violation of the CSA that may result in imprisonment and fines (21 U.S.C. 841, 960). Possession of the steroids unless legally obtained is also subject to criminal penalties (21 U.S.C. 844).

In addition, under the CSA, a nonnarcotic Schedule III substance may be imported only if it is imported for medical, scientific, or other legitimate uses (21 U.S.C. 952(b)) under an import declaration filed with DEA (21 CFR 1312.18). Importation of these Schedule III steroids will be illegal unless the person importing the steroids is registered with DEA as an importer or researcher and files the required declaration for each shipment. An individual who purchases these substances directly from foreign companies and has them shipped to the U.S. is considered to be importing even if the steroids are intended for personal use. Illegal importation of a Schedule III anabolic steroid is a violation of the CSA that may result in imprisonment and fines(21 U.S.C. 960).

Effective January 20, 2005, those substances defined as anabolic steroids became subject to CSA regulatory controls and administrative, civil and criminal sanctions applicable to the manufacture, distribution, dispensing, importing and exporting of a Schedule III controlled substance, including the following:

Registration. Any person who manufactures, distributes, dispenses, imports or exports a substance defined as an anabolic steroid or who engages in research or conducts instructional activities with respect to substances defined as anabolic steroids or who proposes to engage in such activities must be registered to conduct such activities with Schedule III controlled substances in accordance with 21 CFR part 1301.

Security. Substances defined as anabolic steroids are subject to Schedule III-V security requirements and must be manufactured, distributed and stored in accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73, 1301.74, 1301.75(b) and (c), 1301.76 and 1301.77.

Labeling and Packaging. All labels and labeling for commercial containers of substances defined as anabolic steroids which are distributed on or after January 17, 2006, shall comply with requirements of 21 CFR 1302.03-1302.07.

Inventory. Every registrant required to keep records and who possesses any quantity of any substance defined as an anabolic steroid is required to keep an inventory of all stocks of the substances on hand pursuant to 21 CFR 1304.03, 1304.04 and 1304.11. Every registrant who desires registration in Schedule III for any substance defined as an anabolic steroid shall conduct an inventory of all stocks of the substances on hand at time of registration.

Records. All registrants are required to keep records pursuant to 21 CFR 1304.03, 1304.04, 1304.05, 1304.21, 1304.22, 1304.23 and 1304.26.

Prescriptions. All prescriptions for these Schedule III compounds or for products containing these Schedule III compounds would be required to be issued pursuant to 21 CFR 1306.03-1306.06 and 1306.21-1306.27. All prescriptions for these Schedule III compounds or for products containing these Schedule III compounds, if authorized for refilling, would be limited to five refills.

Importation and Exportation. All importation and exportation of any substance defined as an anabolic steroid must be in compliance with 21 CFR part 1312.

Criminal Liability. Any activity with any substance defined as an anabolic steroid not authorized by, or in violation of, the Controlled Substances Act or the Controlled Substances Import and Export Act occurring on or after January 20, 2005, is unlawful.

Persons who possess substances defined as anabolic steroids and who wish to dispose of them rather than becoming registered to handle them should contact their local DEA Diversion field office for assistance in disposing of these substances legally. The DEA Diversion field office will provide the person with instructions regarding the disposal. A list of local DEA Diversion field offices may be found at http://www.deadiversion.usdoj.gov.

The Deputy Administrator certifies that this rulemaking has been drafted in accordance with the principles in Executive Order 12866 section 1(b). DEA has determined that this is a significant regulatory action. Therefore, this action has been reviewed by the Office of Management and Budget. DEA does not have any discretion in the implementation of the Anabolic Steroid Control Act of 2004, and this rule merely codifies those statutory changes.

DEA did, however, analyze the economic impacts of the changes in recognition of the market that exists for these products. DEA was not able to determine the size of the market for these substances with any degree of certainty. The National Nutritional Foods Association indicates that the nutritional supplement market in 2003 had sales of $19.8 billion. The sports nutrition part of the market had sales of $2 billion. Steroid precursors make up some fraction of the sports nutrition market. DEA believes that most steroids sold in dietary supplements in the U.S. are imported in bulk, primarily from China. According to U.S. International Trade Commission data, in the first nine months of 2004, China was the source of 3,900 kilograms of the 4,145 kg of the anabolic agents and androgens imported. The import value of the Chinese product is about $0.27 per gram. The price per gram for pure steroid products, as listed on Internet sites, ranges from $1.39 to $73 (omitting Methyl D, which sells for $150 to more than $500/gram). Most pure products sell for between $2.50 per gram and $32.00/gram. Extrapolating the Chinese imports to a full year and applying the per gram markup, DEA estimates the steroid retail market to range from $13 million to $166 million. Because most steroids have per gram prices of less than $8, DEA estimates that the market is probably in the middle of the range.

DEA also looked at the firms that market steroid containing supplement products. Based on Internet searches, DEA identified 64 firms that sell these products under their brand name. Besides the marketers' websites, the products were available from more than 150 Internet sites that cater to the body building and nutritional supplement market. These products may also be available from some retail store outlets and gyms.

The 64 firms identified as marketing the products under their brand name represent a variety of sectors. DEA was able to locate some industrial sector and financial information for 45 of the firms. Of those whose business category was available, five categorize themselves as food processors who manufacture dry condensed and evaporated dairy products (NAICS 311514) (whey products are widely sold as high protein supplements). Five classified themselves as manufacturers of pharmaceuticals (NAICS 325412) or botanicals (NAICS 325411). Seventeen listed themselves as drug (NAICS 424210) or food wholesalers (NAICS 424490). Twelve listed themselves as store retailers (NAICS 446191, 445299), and two as mail order houses (NAICS 454113). The others for which information was available categorized themselves as a book publisher, a research lab, a radio station, and a doctor's office. There were 19 firms for whom DEA could find no information in U.S. business databases; one of these is British. Of the 18 remaining, DEA was unable to locate any information (web site, address, phone number) on four firms whose products are being sold. Two others had web sites, but no location information, and three had web sites and telephone numbers, but no addresses.

All of the firms identified are small entities under the Small Business Administration standards. Only two of the firms reported revenues above $20 million; one of these filed for Chapter 11 protection in 2003 and has since sold all of its assets. Only three firms had revenues between $10 million and $20 million; all of these listed themselves as drug wholesalers. The 16 firms with revenues between $1 million and $10 million were also mainly wholesalers or manufacturers. Eighteen firms reported revenues of $100,000 to $1 million. Four reported revenues of less than $100,000. Of the firms for which data were found, the majority had fewer than ten employees. It is likely that the firms for which data were not available are very small. Given the size of the firms, it is also likely that these firms are, at most, repackaging or relabeling products manufactured elsewhere.

DEA was not able to identify any firm that appeared to market only the steroid precursors although they may be the main product line for a few firms. Removing these products from the market will undoubtedly have a negative effect on many of the firms. Similarly, the 160 Internet sites identified as selling these products offer a variety of other nutritional products; some also sell sporting equipment, clothing, books, and videos. Because there is no legal substitute that produces the effects claimed for these products, it is likely that both the producers and the Internet sites will experience a loss of revenue. Without information on the percentage of revenues derived from the product lines, DEA is not able to determine whether the removal of these products alone will result in the closure of any of the firms.

The Regulatory Flexibility Act (5 U.S.C. 605(b)), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, applies only to regulations subject to notice and comment. Because DEA is simply promulgating a final rule to conform to statutory provisions, the Regulatory Flexibility Act does not apply to this action.

An agency may find good cause to exempt a rule from certain provisions of the Administrative Procedure Act, including notice of proposed rulemaking and the opportunity for public comment, if it is determined to be unnecessary, impracticable, or contrary to the public interest (5 U.S.C. 553). The provisions of the Anabolic Steroid Control Act of 2004, Public Law 108-358, are self-implementing. DEA has no discretion in this matter. The changes in this rulemaking provide conforming amendments to make the language of the regulations consistent with that of the law. Hence, DEA finds it unnecessary to publish for public notice and comment.

This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.

This rulemaking does not preempt or modify any provision of state law; nor does it impose enforcement responsibilities on any state; nor does it diminish the power of any state to enforce its own laws. Accordingly, this rulemaking does not have federalism implications warranting the application of Executive Order 13132.

This rule will not result in the expenditure by state, local and tribal governments, in the aggregate, or by the private sector, of $115,000,000 or more in any one year, and will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

On April 14, 2005, the IRS and Treasury Department published in the Federal Register temporary regulations (TD 9197, 2005-18 I.R.B. 985 [70 FR 19697]) and a notice of proposed rulemaking (REG-148521-04, 2005-18 I.R.B. 995 [70 FR 19722]) under section 7701 of the Internal Revenue Code (Code). The regulations added certain foreign business entities to the list of entities in § 301.7701-2(b)(8) (the per se corporation list) in response to the adoption by the Council of the European Union of a Council Regulation (2157/2001 2001 O.J. (L 294)) permitting a new business entity, the European public limited liability company (Societas Europaea or SE). Specifically, the temporary and proposed regulations added the SE, Estonian Aktsiaselts, Latvian Akciju Sabiedriba, Lithuanian Akcine Bendroves, Slovenian Delniska Druzba, and Liechtenstein Aktiengesellschaft to the per se list of corporations. For further background see TD 9197 (2005-18 I.R.B. 985; 70 FR 19697) and Notice 2004-68 (2004-2 CB 706).

No substantive comments were received regarding the temporary and proposed regulations. Accordingly, these regulations finalize the proposed regulations without modification and revise the temporary regulations to cross reference to the new provisions.

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

The principal author of these regulations is Ronald M. Gootzeit of the Office of Associate Chief Counsel (International). However, other personnel from the IRS and Treasury Department participated in their development.

Background

When an oil and gas lease is issued on the OCS, the lessee has flexibility to schedule activities during the primary term, the prescribed term of years for which the lease was issued. At the end of the primary term, the lease can continue in force by production, drilling, or well-reworking operations as approved by the Regional Supervisor. When leaseholding operations (production, drilling, or well-reworking operations) are not maintaining the lease at the end of the primary term, if oil or gas was discovered, and if there is a commitment to produce, the operator may request a Suspension of Production (SOP), which stops the running of the lease term and prevents the lease from expiring. Before the discovery of oil or gas on a lease, MMS regulations at 30 CFR 250.172, 250.173, and 250.175 authorize suspensions of operations, but only in limited circumstances. An SOO stops the running of the lease term and prevents the lease from expiring.

Most leases have a primary term of 5 years, although a longer period (10 years) is provided in deep water. Some leases in intermediate depths have primary terms of 8 years, with a requirement to drill an initial well in the first 5 years. Under most circumstances, the primary lease term provides sufficient time to acquire and interpret geophysical information needed to determine the presence of oil or natural gas, drill a well, and for the operator to determine whether or not to continue with development and production. However, there are cases when a company recognizes that there is a potential hydrocarbon reservoir that is below 25,000 feet true vertical depth below the datum at mean sea level (TVD SS). The high cost of drilling an ultra-deep (below 25,000 feet TVD SS) well, along with the associated geologic and mechanical risks, warrants completing additional data analysis before drilling.

In 2002, MMS amended the regulation at 30 CFR 250.175 to provide for an SOO if additional time was needed to allow a lessee to analyze areas beneath or adjacent to salt sheets. MMS added this provision in the belief that when a lessee conducts significant work, additional time may be warranted to allow the lessee to benefit from the work conducted. Lessees used the change to expand their exploration in areas affected by salt sheets. The rule included well-defined, specific criteria for determining when a lease is eligible for a suspension. Vertical depth is not a criteria under the existing rule.

While the rule issued in 2002 encouraged drilling under salt sheets, that rule does not address situations where salt does not exist. Information from industry indicates that large accumulations of hydrocarbons may exist at depths greater than 25,000 feet TVD SS in water depths less than 800 meters. Many companies are reluctant to drill to these depths without additional data analysis.

The current regulations (see 30 CFR 250.175(b)) allow the lessee or operator to request an SOO if: (1) By the end of the third year of the primary term, geophysical information was gathered that indicated the presence of a salt sheet; (2) all or a portion of a hydrocarbon-bearing formation may lie beneath or adjacent to the salt sheet; and (3) the salt sheet interferes with identifying the potential hydrocarbon-bearing formation. In August 2004, MMS issued Notice to Lessee (NTL) No. 2004-G16, providing additional guidance for granting an SOO to lessees or operators who planned to drill a well beneath or adjacent to a salt sheet. The NTL allowed the lessee or operator planning to drill an ultra-deep well to request the SOO if this geophysical information was gathered by the end of the fifth year of the primary term, instead of at the end of the third year. In addition, the operator had to submit a reasonable working schedule leading to the commencement of drilling. This final rule will replace the NTL, and also allow the lessee or operator to request an SOO for ultra-deep exploration in areas where a salt sheet does not exist.

Allowing a lessee additional time for this data analysis encourages companies to consider ultra-deep exploration. A successful development will generate more activity at lease sales and increase drilling on existing leases.

MMS recognizes that a lessee knows the length of the lease term when it obtains a lease. When a lease expires, another lessee can acquire a new lease on the same tract. MMS considered these factors, and believes that the need to encourage drilling to significantly deeper depths warrants the final rule change. Successful wells benefit not only the companies that drilled the wells, but also the public by increasing domestic energy sources. In addition, the drilling of successful wells will encourage other companies to acquire leases and to pursue ultra-deep exploration in United States (U.S.) waters.

MMS published a proposed rule on February 14, 2005 (70 FR 7451). The public comment period ended on March 16, 2005. MMS received ten sets of comments on the proposed rule. The comments came from two private citizens, five oil and natural gas production companies (ExxonMobil, Chevron, Newfield, Murphy, and Shell), and three sets of comments that represent various aspects of the offshore oil and natural gas industry. The International Association of Drilling Contractors (IADC) and the International Association of Geophysical Contractors (IAGC) sent separate comments. The American Petroleum Institute (API), Domestic Petroleum Council (DPC), Independent Petroleum Association of America (IPAA), Offshore Operators Committee (OOC), and U.S. Oil and Gas Association (USOGA) sent one set of comments. Some commenters agreed with the need to encourage ultra-deep drilling and supported the change. Some commenters did not support the proposed change. Some commenters made recommendations about the rule and its implementation. You may view these comments on MMS' Public Connect on-line commenting system at: https://ocsconnect.mms.gov.

Comment: A private citizen wanted to know how we decided to use 25,000 feet TVD SS as the threshold, and why 20,000 feet TVD SS was not used.

Response: Approximately 4 1/2 times as many wells are drilled to 20,000 feet or greater TVD SS than are drilled to depths of 25,000 feet or greater TVD SS. The drilling of wells to depths of 25,000 feet TVD SS or greater presents a myriad of technological drilling challenges to the operator warranting an SOO.

Comment: A private citizen expressed concern that the rule would allow for lease extensions off the coast of California. The commenter stated that the documentation provided was legally inadequate to determine the location and extent of the proposed activities. The commenter stated opposition to the rule if it involves the California coast.

Response: The rule meets all of the necessary legal requirements. The purpose of this rule is to allow an SOO in very limited circumstances. Currently, the conditions for applying for an SOO under this rule exist only in the Gulf of Mexico (GOM) Region; but the rule is applicable to all areas of the OCS.

Comment: Two of the oil and natural gas production companies suggested that MMS consider longer primary lease terms. One of these comments suggested 10-year lease terms on all new GOM leases. The other suggested that MMS grant an extension to the primary lease term for ultra-deep exploration. This would be done by a process similar to the request for the SOO.

Response: The issue of longer primary lease terms is beyond the scope of this rule. MMS considered issuing longer primary lease terms for ultra-deep exploration, and discussed this option in the preamble of the proposed rule. However, it is not feasible because when leases are issued it is difficult to know which ones may be suitable for ultra-deep drilling. MMS believes that allowing lessees and operators to apply for an SOO adequately addresses the issue.

Comment: Two of the oil and natural gas production companies suggested changes to the wording of the rule to ensure that it is clear that the rule covers hydrocarbon bearing formations when only a portion of the formation lies below 25,000 feet TVD SS. Also, they suggested that the wording is inconsistent between § 250.175(c)(2) and (3).

Response: MMS considered this comment, but we did not change the wording in the final rule. We recognize that a hydrocarbon-bearing formation may lie below 25,000 feet TVD SS and extend to a depth less than 25,000 feet TVD SS. However, the primary focus of this rule is to encourage the drilling of ultra-deep wells below 25,000 feet TVD SS by granting an SOO for additional geological or geophysical analysis before drilling such wells. Although § 250.175(c)(2) allows the required initial seismic work to indicate that “all or a portion of” the potential hydrocarbon-bearing formation is below 25,000 feet TVD SS, the objective of granting a suspension is to identify a potential hydrocarbon-bearing geologic structure or stratigraphic trap with a target drilling depth below 25,000 feet TVD SS. New § 250.175(c)(3) states that the objective of additional data processing or interpretation of geophysical information must be to identify a potential hydrocarbon-bearing geologic structure or stratigraphic trap below 25,000 ft. TVDSS. The lessee must demonstrate that it has conducted additional data processing or interpretation with that objective.

Comment: A commenter asked if the rule would allow MMS to grant an SOO on multiple leases that share an individual prospect, geological structure, or stratigraphic trap, without forming units.

Response: MMS may grant an SOO on multiple leases without the leases being unitized if the leases share a common geological structure or stratigraphic trap. Lessees or operators may also request an SOO for units. The lessee or operator must file a separate request for an SOO on each lease or unit, and must meet all other conditions of the regulations.

Comment: One commenter suggested that MMS add the following activities to § 250.175(c)(4) for further clarification: (1) Allow additional time to properly design and plan the well and (2) acquire a suitable drilling rig.

Response: The regulations already allow a reasonable time to begin drilling operations, including time for designing and planning the well and acquiring a drilling rig. We did not make the suggested change.

Comment: One commenter discussed the possible need for additional suspensions after the well is drilled. Additional time would be needed to evaluate these wells before an operator would commit to develop the well as required for an SOP.

Response: Section 250.175(c)(4)(ii), as proposed, allows for an SOO to be granted to “acquire, process, or interpret new geophysical or geologic data or information.” Therefore, under this rule additional suspensions could be granted for a reasonable time period to allow geologic well data to be evaluated.

Comment: Two commenters expressed concern about the impact the rule will have on industries that support drilling operations in the GOM. Some support industries rely on regular drilling and lease turnovers. These industries have made investments based on the current regulatory scheme, and by changing these regulations MMS will be impacting drilling activities and lease turnover rates. They contend that MMS should reconsider the rulemaking because of these impacts.

Response: MMS did not change the rule because we do not believe that this rule will have a substantial impact on drilling activities or lease turnover rates. The rule will impact a very small percentage of leases. In the preamble of the proposed rule, MMS estimated that it would receive less than 10 requests for suspensions each year. There are more than 4,300 active leases in the areas that are eligible for suspensions under this rule. This change is expected to affect less than 0.23 percent of leases in the eligible areas. This rule change, combined with any applicable deep-gas royalty relief, is expected to gradually increase drilling activities into areas deeper than 25,000 feet TVD SS.

Comment: There was one suggestion that the rule apply only to leases issued after the effective date of the rule.

Response: In order for the rule to have the maximum impact and help meet current energy demands, the rule will apply to existing and new leases.

Comment: One commenter expressed concern about the length of time for which the SOO would be issued. The commenter suggested that MMS include provisions to ensure that the SOO is issued for the minimum amount of time needed for the lessee or operator to complete the activities.

Response: MMS will require the lessee or operator to submit measurable “milestones” to verify that it is completing the work within a reasonable timeframe. We did not change the rule.

Comment: One industry group requested that MMS modify the rule to “Provide assurance that MMS will rigorously pursue the execution of 30 CFR 250.170(e)” which sets the terms and condition for terminating suspensions.

Response: MMS did not incorporate the suggested change. We have an effective mechanism in place to monitor all lease suspensions and may terminate any suspension if it determines that the circumstances which justified the suspension no longer exist.

Comment: A commenter requested that MMS “[E]nsure that the lessee or operator has bona fide plans to drill an ultra-deep well, by specifying in the rule requirements for evidence such as signed AFEs, signed and binding contracts for drilling rigs or ships capable of drilling to such depths, etc.”

Response: MMS will require specific information, as determined by the Regional Supervisor, which supports the lessee or operator's exploration plans, including any plans to drill an ultra deep well, on a case-by-case basis.

Comment: A commenter requested that MMS limit the number of suspensions of operations that would be available under a given lease or prospect to one extension regardless of the various expiration dates of the adjacent leases covered by the prospect.

Response: MMS does not agree with this suggestion and will not limit the number of suspensions available under a given lease or prospect. However, the lessee or operator must file a separate request for each SOO, and each request must meet all of the criteria to receive approval.

Comment: One commenter suggested that MMS should limit the extent of the area that is subject to the SOO where possible.

Response: The Regional Supervisor will determine the area subject to the SOO on a case-by-case basis.

Comment: One commenter suggested that MMS require the lessee/operator to sever their rights above 25,000 feet TVD to secure the SOO.

Response: The lessee was awarded the lease through a competitive bidding process. Each lessee acquired an interest in the entire property. The lessee or operator may pursue the right to explore, develop, and produce, without waste, anywhere on the lease. MMS will not jeopardize this right.

Comment: One commenter suggested that this rule is in violation of Executive Order 12630—Takings, because of the possible economic impact the rule could have on some businesses associated with the offshore oil and natural gas industry. These companies invested money based on the MMS's regulatory program and this rule represents a change to that program that may slow some activities.

Response: MMS reviewed Executive Order 12630—Takings, and determined that the rule does not violate that order.

Comment: One commenter requested that MMS define the “SS” in “TVD SS” as “sub-seafloor,” so that the water column would not be included in the depth.

Response: TVD SS is “the true vertical depth below the datum at mean sea level,” (see regulations at § 203.0). MMS will continue to use the term “datum at mean sea level” in this rule, to be consistent with other provisions of existing regulations and common practices of depth measurement.

Comment: One commenter suggested that the wording of the rule is inconsistent and that § 250.175(c)(3) should use “structure or trap” instead of “formation.” This section requires that the lessee or operator either has conducted or is conducting additional data processing or interpretation of the geophysical information to identify the potential ultra-deep hydrocarbon-bearing formation. The commenter contends that § 250.175(c)(2) already requires that the operator or lessee have the information that indicates there is a potential formation already established.

Response: MMS agrees and changed § 250.175(c)(3) to read “geophysical information with the objective of identifying a potential hydrocarbon-bearing geologic structure or stratigraphic trap lying below 25,000 feet TVD SS.” While § 250.175(c)(2) focuses on the type of data required and the initial interpretation of that data, new § 250.175(c)(3) refers to additional information and a more complete interpretation that may lead to the drilling of a well below 25,000 feet TVD SS.

Comment: An industry group expressed concern because drilling contractors must finance their fleets on the basis of reliable government drilling programs which by finite license terms afford the certainty that leases either will be drilled or dropped and re-offered to operators with the appetite and resources to develop them.

Response: Granting an SOO under this rule is only one very small part of the overall scenario. Fleet financing is largely dependent and driven by global competition, market demands, and the aggressiveness of the industry to explore and develop leases. There are more than 4,300 active leases in the areas that are eligible for suspensions under this rule. In any given year, MMS estimates that it will receive no more than 10 requests for suspensions under this rule. This change is expected to affect less than 0.23 percent of leases in the eligible areas.

Comment: A comment from an industry group stated that MMS seems to be accelerating the transformation of OCS leases into virtual long-term purchases. They urged MMS to reconsider this proposal, and to take note of its implications for the economic viability of the offshore contractor infrastructure put at risk by increasingly unreliable primary lease terms.

Response: This is not the case. As appropriate drilling rigs become available and drilling technology advances, the need for this type of suspension will decline. The exploration and development of leases is actively monitored by MMS, and mechanisms are in place to urge the lease operator to either develop the lease or it will expire. There are more than 4,300 active leases in the areas that are eligible for suspensions under this rule. In any given year, MMS estimates it will receive no more than 10 requests for suspensions under this rule. This change is expected to affect less than 0.23 percent of leases in the eligible areas.

MMS made only minor wording changes to the final rule, based on the comments received. In § 250.175(c), the wording was changed from “for drilling” to “conduct additional geological and geophysical (G&G) data analysis which may lead to the drilling.” This was done to clarify that the SOO can be used for the additional data analysis needed to prepare for the drilling of a well below 25,000 feet TVD SS.

In § 250.175(c)(3) and (4)(iii), MMS changed the word “formation” to “geologic structure or stratigraphic trap.” Section 250.175(c)(2) requires an initial interpretation of the data that indicates a potential hydrocarbon-bearing formation. Section 250.175(c)(3) requires additional data processing and information interpretation that may lead to drilling a well below 25,000 feet TVD SS. MMS changed the wording in § 250.175(c)(4)(iii) for consistency.

This is not a significant rule as determined and is not subject to review under Executive Order 12866.

The major economic effect of the final rule will involve business decisions made by oil and gas producers. MMS expects that a project to drill an ultra-deep well will need to compete with other high-risk projects in deep water or in other countries. By increasing the potential benefits resulting from drilling high-risk, ultra-deep wells, lessees will be more likely to drill these wells in the U.S. instead of drilling in other high-risk areas.

These decisions are based on marginal cost and benefit differences among projects, and are driven by many factors. This final rule is only one of the factors. Lessees or operators will not request a suspension unless it is in their financial interest. Therefore, this final rule change will not impose a net cost on the lessee or operator.

There are other financial considerations that will result directly from this final rule. Drilling a well to 25,000 or more feet TVD SS is a significant occurrence, and MMS does not anticipate an immediate drastic increase in drilling to that depth. This rule change, combined with any applicable deep-gas royalty relief, is expected to gradually increase drilling activities into areas deeper than 25,000 feet TVD SS.

MMS estimates that this rule will result in 10 suspension requests per year, averaged over the 5 years following the effective date of a final rule; and that most of the requests will be in water depths of less than 200 meters. MMS' economic analysis assumes that a suspension will result, on average, in each suspended lease remaining active for 2 years longer than without the suspension. Of the leases in water depths of less than 200 meters that expired in 2000, approximately half received new bids within 2 years, with an average high bid of approximately $556,000. The delayed expiration of the leases for which suspensions are requested under this rule will result in a delay in reoffering the tracts. If the anticipated 10 leases that would have expired without a suspension were to be offered in a lease sale, MMS estimates that five would receive bids at an average of $556,000 per lease, for a total of $2,780,000. This final rule is estimated to result in a 2-year delay in the receipt of that $2,780,000 in bonus revenues.

However, this delay in receiving re-leasing revenues will be partially offset by increased government revenue due to the continued collection of rents. The extra rent generated by the anticipated suspended leases will be $500,000 ($5.00 rent per acre × 5,000 acres × 10 leases × 2 years). The greater potential effect of this final rule is the additional royalties collected if large reservoirs of hydrocarbons are discovered in ultra-deep areas, as well as the effect of success on bonuses and rents in future lease sales.

The presently quantifiable effects of this final rule are small compared to the potential for an increase in energy production. There are more than 4,300 active leases in the areas that are eligible for suspensions under this rule. In any given year, MMS estimates that it will receive no more than 10 requests for suspensions under this rule. This change is expected to affect less than 0.23 percent of leases in the eligible areas. The main effect of this final rule is the potential impact on energy and domestic production if a large reservoir of hydrocarbons is discovered.

(1) This final rule will not have an annual 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.

(2) This final rule will not create a serious inconsistency or otherwise interfere with an action taken or planned by another agency. Issuance of a suspension for a lease does not interfere with the ability of other agencies to exercise their authority.

(3) This final rule would not alter the budgetary effects of entitlements, grants, user fees, or loan programs or the rights or obligations of their recipients. This change will have no effect on the rights of the recipients of entitlements, grants, user fees, or loan programs.

(4) This final rule will not raise novel legal or policy issues.

The Department certifies that this final rule will not have a significant economic effect on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ).

This change will affect lessees and operators of leases in the OCS. This includes about 130 different companies. These companies are generally classified under the North American Industry Classification System (NAICS) code 211111, which includes companies that extract crude petroleum and natural gas. For this NAICS code classification, a small company is one with fewer than 500 employees. Based on these criteria, an estimated 70 percent of these companies are considered small. This final rule, therefore, will affect a substantial number of small entities.

This final rule will not create a cost to small companies since it provides a suspension only when one is requested. Small companies could be affected by the delay in the expiration of leases and the availability of the tract to be leased again. As discussed earlier, this is a very small portion of the available leases. The final rule will not affect the ability of a small company to participate in OCS exploration, development, and production.

Comments are important. The Small Business and Agriculture Regulatory Enforcement Ombudsman and 10 Regional Fairness Boards were established to receive comments from small business about Federal agency enforcement actions. The Ombudsman will annually evaluate the enforcement activities and rate each agency's responsiveness to small business. If you wish to comment on the actions of MMS, call 1-888-734-3247. You may comment to the Small Business Administration without fear of retaliation. Disciplinary action for retaliation by an MMS employee may include suspension or termination from employment with the Department of the Interior.

This is not a major rule under the SBREFA (5 U.S.C. 804(2)). This final rule:

(a) Will not have an annual effect on the economy of $100 million or more.

(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.

(c) Will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.

This final rule will not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The final rule will not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the UMRA (2 U.S.C. 1531 et seq. ) is not required. This is because the proposal will not affect State, local, or tribal governments, and the effect on the private sector is small.

With respect to Executive Order 12630, the final rule will not have takings implications. A Takings Implication Assessment is not required. The rulemaking is not a governmental action capable of interfering with constitutionally protected property rights.

With respect to Executive Order 13132, the final rule will not have federalism implications. It will not substantially and directly affect the relationship between the Federal and state governments. To the extent that state and local governments have a role in OCS activities, this final change will not affect that role.

With respect to Executive Order 12988, the Office of the Solicitor has determined that this final rule will not unduly burden the judicial system, and meets the requirements of Sections 3(a) and 3(b)(2) of the Executive Order.

Under the criteria in Executive Order 13175, we have evaluated this rule and determined that it has no potential effects on federally recognized Indian tribes because OCS operations do not take place on or near Indian lands.

The PRA provides that an agency may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. Until OMB approves a collection of information and assigns a control number, you are not required to respond. The revisions to 30 CFR part 250 subpart A refer to, but do not change, information collection requirements in current regulations. OMB has approved the referenced information collection requirements under OMB control number 1010-0114, current expiration date of October 31, 2007. The final rule will impose no new paperwork requirements, and an OMB form 83-I submission to OMB under the PRA is not required.

Executive Order 12866 requires each agency to write regulations that are easy to understand. We invite your comments on how to make this rule easier to understand, including answers to questions such as the following:

(1) Are the requirements in the rule clearly stated?

(2) Does the rule contain technical language or jargon that interferes with its clarity?

(3) Does the format of the rule (grouping and order of sections, use of headings, paragraphing, etc.) aid or reduce its clarity?

(4) Is the description of the rule in the SUPPLEMENTARY INFORMATION section of this preamble helpful in understanding the rule? What else can we do to make the rule easier to understand?

Send a copy of any comments that concern how we could make this rule easier to understand to: Office of Regulatory Affairs, Department of the Interior, Room 7229, 1849 C Street, NW., Washington, DC 20240. You may also e-mail the comments to this address: Exsec@ios.doi.gov.

MMS analyzed this rule using the criteria of the NEPA and 516 Departmental Manual, Chapter 2, and concluded that the preparation of an environmental analysis is not required.

This is not a significant rule and is not subject to review by OMB under Executive Order 13211. The final rule may potentially increase energy supplies, but given the uncertainty associated with the drilling of successful wells, the effect on energy supply, distribution, or use is not considered to be significant at this time. Thus, a Statement of Energy Effects is not required.

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted, without change, to http://dms.dot.gov and will include any personal information you have provided. We have an agreement with the Department of Transportation (DOT) to use the Docket Management Facility. Please see DOT's “Privacy Act” paragraph below.

A. Submitting comments: If you submit a comment, please include your name and address, identify the docket number for this rulemaking [USCG-2004-19963], indicate the specific section of this document to which each comment applies, and give the reason for each comment. You may submit your comments and material by electronic means, mail, fax, or delivery to the Docket Management Facility at the address under ADDRESSES ; but please submit your comments and material by only one means. If you submit them by mail or delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period. We may change this interim rule in view of them.

B. Viewing comments and documents: To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://dms.dot.gov at any time and conduct a “simple search” using the last five digits of the docket number. You also may visit the Docket Management Facility in room PL-401 on the Plaza level of the Nassif Building, 400 Seventh Street SW., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

C. Public meeting: We do not now plan to hold a public meeting. However, you may submit a request for one to the Docket Management Facility at the address under ADDRESSES explaining why one would be beneficial. If we determine that a public meeting would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

D. Privacy Act: Anyone can search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review the Department of Transportation's Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477), or you may visit http://dms.dot.gov.

On August 18, 2004, the Coast Guard published a temporary rule entitled “Notification of Arrival in U.S. Ports; Certain Dangerous Cargoes; Electronic Submission.” 69 FR 51176. This temporary rule, which expires March 20, 2006, added ammonium nitrate and ammonium nitrate based fertilizers, in bulk, and propylene oxide, alone or mixed with ethylene oxide, in bulk, to the list of Certain Dangerous Cargoes (CDCs) for which a notice of arrival (NOA) is required under 33 CFR part 160.

CDCs are specifically defined in 33 CFR 160.204, but may generally be described as substances or materials that pose an unreasonable risk to health, safety, and property if improperly handled. The notice of arrival is the process in which a vessel submits required information—including data about the vessel, cargo, crew and others on board before the vessel arrives at a port or place in the United States. The required information contained in the notice of arrival allows the Coast Guard to properly screen the vessel for safety and security purposes.

The temporary rule was issued in large part because of information the Coast Guard had received from other federal agencies in late 2003 on the dangers of ammonium nitrate and ammonium nitrate based fertilizers, in bulk. While considering adding these cargoes to the CDC list, the Coast Guard requested comments from the Towing Safety Advisory Committee (TSAC) and the Chemical Transportation Advisory Committee (CTAC). Those committees were asked to advise the Coast Guard on the anticipated impact to their respective industries if solid ammonium nitrate and ammonium nitrate fertilizers, in bulk, were added to the CDC definition in 33 CFR part 160. The Coast Guard received recommendations from TSAC on September 10, 2003, and from CTAC on October 23, 2003. Neither committee specifically recommended adding forms of ammonium nitrate to the CDC list. Both committees acknowledged, however, the security hazards associated with forms of ammonium nitrate and agreed that additional security measures were warranted.

The temporary rule also added propylene oxide, alone or mixed with ethylene oxide, in bulk, to the list of CDCs for the following reasons—

• It is chemically similar to ethylene oxide, which is already on the list of CDCs;

• It is extremely reactive to acids, bases, oxidizers, peroxides, and many other chemicals;

• When exposed to heat, it polymerizes, or reacts with itself, and gives off large amounts of heat;

• It has a wide flammability range, meaning that it can mix with air to form an explosive mixture at low (2.3 percent) or high (37 percent) concentrations; and,

• It has a high vapor pressure, meaning that it generates large amounts of flammable and reactive vapor at room temperature.

The temporary rule also provided one new option, consisting of two separate formats, for electronically submitting an NOA to the Coast Guard's National Vessel Movement Center (NVMC). Finally, the temporary rule clarified that vessel security regulations in 33 CFR part 104 apply to the owner or operator of any (1) barge carrying CDC in bulk or (2) barge subject to 46 CFR chapter I, subchapter I, that is engaged on an international voyage.

The Coast Guard received four letters commenting on the temporary rule. The letters were from a national trade association, an advisory committee, a barge transportation company, and a science and technology company. All of the comments addressed issues relating to CDC generally. There were no comments addressing electronic submission of NOAs.

A. Adding Propylene Oxide: One commenter agreed with the addition of propylene oxide to the list of CDCs, stating “The addition of Propylene Oxide (POX) as a Certain Dangerous Cargo is an appropriate action, as it is a high risk cargo by any measurement.”

B. CDC Residue: One comment discussed CDC liquid residue (“slops”) remaining on a vessel after the CDC has been discharged from the vessel. The comment stated that vessels carrying only small quantities of CDC liquid residue are still subject to NOA reporting requirements until that material is discharged from the vessel. As an example, it stated that the Coast Guard classifies a vessel that has carried a liquid CDC as a CDC vessel until it is totally free from dangerous concentrations of flammable or toxic gases (“gas free”). It also stated, “as a result, both the Coast Guard and industry are forced to utilize time, money, and resources to implement the additional requirements even when no particular hazard exists.”

The Coast Guard disagrees with the commenter's assertion that residue from liquid CDCs present no particular hazard. The residue of bulk liquid and bulk liquefied gas CDCs continues to retain its physical properties of flammability and toxicity despite the reduction in quantity of the CDC, and these physical properties are what make certain cargoes CDCs. Therefore, this rule does not modify current requirements for bulk liquid and bulk liquefied gas CDCs, regardless of amount.

However, the Coast Guard agrees that some non-liquid residues should not be included in the definition of CDC. Coast Guard discussed with the Office of Naval Intelligence and the Bureau of Alcohol, Tobacco, Firearms, and Explosives, the safety and security concerns related to the residue of ammonium nitrate and the residue of ammonium nitrate based fertilizers, in bulk. We conclude that it is not necessary to require an NOA when a vessel is carrying only residue of ammonium nitrate or residue of ammonium nitrate based fertilizers, in bulk, under certain circumstances. For example, a barge carrying dry bulk ammonium nitrate delivers to, and discharges its cargo at, a facility. Small quantities of residue may remain scattered around the edges and the rest of the floor area of the barge. In this instance, the Coast Guard agrees that it would be unnecessary for a company to clean all residue from the barge completely so that the Part 160 requirements no longer apply to that barge.

C. Beyond the Scope of this Rulemaking: All four commenters raised a number of issues that were outside the narrow scope of the temporary rule. Those issues generally relate to implementation of the vessel and facility security regulations in 33 CFR parts 104 and 105. The issues included concerns about segregation of barges carrying ammonium nitrate or ammonium nitrate fertilizers from other dry cargo barges at fleeting facilities—a commercial area for the making up, breaking down, or staging of barge tows; requests to make the Inland River Vessel Movement Center and NVMC reporting requirements the same; suggestions to allow vessel operators to “turn on” and “turn off” the vessel security plans of uninspected barges depending on whether they are carrying CDCs; and storage of security plan documentation onboard dry cargo barges.

Because the only purpose of this rulemaking is to make permanent the changes from the temporary rule with minor modifications, the aforementioned issues are not within the narrow scope of this rulemaking and we do not address them in this rule. However, we have forwarded these comments to the appropriate program staff for further consideration and appropriate action.

In addition, these comments asked questions about when and how owners and operators with approved security plans or Alternative Security Plans should proceed with security plan changes relating to the new CDCs as well as questions about completing the required Declarations of Security. Such questions should be addressed to LCDR Rob McLellan,G-MPS, Coast Guard, 202-267-4129.

This interim rule makes permanent the changes to 33 CFR parts 104 and 160 introduced by the August 18, 2004 temporary rule. These permanent changes are necessary to promote maritime safety and security and to facilitate the uninterrupted flow of commerce. This rule permanently adds to the definition of CDC, in 33 CFR 160.204, ammonium nitrate and ammonium nitrate based fertilizers, in bulk, and propylene oxide, alone or mixed with ethylene oxide, in bulk.

This interim rule also makes permanent one new option, consisting of two separate formats, for electronically submitting a NOA to the Coast Guard's National Vessel Movement Center (NVMC). Finally, this rule adopts the change the temporary rule made to the applicability of vessel security regulations in 33 CFR part 104, which limited applicability to barges that are carrying CDC in bulk to those engaged on international voyages.

This interim rule also contains editorial revisions and clarifications to the NOA regulation that are not in the temporary rule. One of the changes is a revision to the definition of certain dangerous cargo which eliminates the reporting requirement for vessels that retain only a non-liquid residue of ammonium nitrate or ammonium nitrate based fertilizer, in bulk. The second change is that this rule adds an option for vessels to submit notices of arrival electronically. The third change is only an editorial clarification that has no substantive effect, clarifying that U.S. recreational vessels are not subject to part 160 requirements.

This interim rule defines ammonium nitrate and ammonium nitrate based fertilizers, in bulk, to exclude non-liquid residue of ammonium nitrate and residue of ammonium nitrate based fertilizer after discharging saleable cargo. The definition for “Certain dangerous cargo residue (CDC residue)” in § 160.204 now excludes from the NOA reporting requirements ammonium nitrate, in bulk, and ammonium nitrate based fertilizer, in bulk, remaining after all saleable cargo is discharged, not exceeding 1,000 pounds in total and not individually accumulated in quantities exceeding two cubic feet.

This interim rule updates the electronic submission options by adding the new eNOAD Microsoft InfoPath template as another electronic submission format. This rule also permanently adds an optional method, the Electronic Notice of Arrival and Departure (eNOAD) system, for electronically submitting a NOA to the Coast Guard's NVMC. On January 31, 2005, the Coast Guard replaced its electronic NOA (e-NOA) system with the newer eNOAD system. The new eNOAD has Microsoft InfoPath as a third optional electronic format for submittal. The Coast Guard has worked with the Bureau of Customs and Border Protection (CBP) in developing the eNOAD so that it may be used to meet both the Coast Guard's notice of arrival requirements and CBP's Sea Advance Passenger Information System (APIS) requirements. This will eliminate duplicative reporting. On April 7, 2005, CBP published a final rule concerning the use of eNOAD. 70 FR 17819.

The eNOAD system, available on the NVMC Web site at http://www.nvmc.uscg.gov, consists of the following three submission formats:

1. An online web format that can be used to submit NOA information directly to the NVMC;

2. Raw Extensible Markup Language (XML) formatted documents that conform to the eNOAD schema, provided for those interested in creating their own application. This format would allow offline data input and would allow users to draw information from their existing systems to submit, via web service, XML formatted data to comply with NOA requirements; and

3. A new Microsoft InfoPath template, designed for those wanting to input NOA data offline (when not connected to the Internet) for submission later via their Internet connection or as an e-mail attachment to the NVMC.

For more information on any of these formats, please contact the NVMC at sans@nvmc.uscg.gov or by telephone at 1-800-708-9823 or 304-264-2502, or visit the NVMC Web site listed above and click on “FAQ” or “Downloads.”

The rule clarifies that the notice of arrival provisions in part 160 do not apply to U.S. recreational vessels. Based on queries from industry and local USCG assets, we have revised the language to clearly state that part 160 does not apply to U.S. recreational vessels under 46 U.S.C 4301. However, this part does apply to foreign recreational vessels. This change does not substantively alter the scope of the applicability in part 160.

Finally, this interim rule also removes the temporary provisions that are in parts 104 and 105 that are no longer needed. The paragraphs being removed are § 104.115(d), § 104.410(g), § 105.115(c), and § 105.410(g).

Implementation of this rule as an interim rule is based upon the “good cause” exception found under the Administrative Procedure Act (APA) at 5 U.S.C. 553(b)(B). Delaying implementation of this rule to await public notice and comment is unnecessary and contrary to the public interest.

This interim rule adopts changes made by the temporary rule. There was a 90-day post-promulgation comment period for that temporary rule and the Coast Guard received only four comments. The Coast Guard considered those comments when drafting this interim rule and addressed them above.

In addition to adopting changes introduced by the temporary rule that were subject to notice and comment, this interim rule makes only three changes: one change relieves a burden, another clarifies that the rule does not apply to certain vessels, and the third offers an additional option for submitting a notice of arrival. These changes either have no effect on the public, or ease a public burden by relaxing the regulatory requirement or providing more options in the reporting requirement. For these reasons, the Coast Guard finds good cause to publish this interim rule without first publishing an NPRM.

Although we have good cause to publish this rule without prior notice and comment, we value public comments. As a result, we are soliciting public comments on this interim rule and may revise the final rule in response to those comments.

Executive Order 12866, “Regulatory Planning and Review,” 58 FR 51735, October 4, 1993, requires a determination whether a regulatory action is “significant” and therefore subject to review by the Office of Management and Budget (OMB) and subject to the requirements of the Executive Order. This rule has been identified as significant under Executive Order 12866 and has been reviewed by OMB. A Regulatory Assessment is available in the docket as indicated under the “Public Participation and Request for Comments” section of this preamble. A summary of the analysis follows.

As in the temporary rule, the two cost elements in the interim rule are the NOA requirements and the vessel and facility security requirements associated with the Maritime Transportation Security Act of 2002 (“MTSA”, Public Law 107-295, 116 Stat. 2064). Vessels that transport CDC materials already are required to submit NOAs to the Coast Guard. 33 CFR 160.202 and 160.212. Vessels and facilities that carry and handle CDC materials are required to implement security measures to comply with MTSA regulations (Vessel Security Plans, 33 CFR part 104; Facility Security Plans, 33 CFR part 105).

For our analysis of the costs of this interim rule, we have retained the estimate from the Regulatory Assessment conducted for the August 2004 temporary rule of about 9,200 barges that can potentially transport ammonium nitrate and propylene oxide. In addition, we retained from the same Regulatory Assessment an estimate of 50 as the average number of fleeting facilities that can potentially receive these two cargoes and the estimate of approximately 11,400 port calls made by about 2,220 vessels that can potentially carry CDC materials.

The initial cost of the interim rule for the NOA and the security requirements is approximately $6.8 million (non-discounted), which covers the preparation of NOAs, the security requirements for vessels and facilities, and the installation, operation and maintenance of equipment that may be required to upgrade facility security. The annual cost of the interim rule for the NOA and the security requirements is approximately $4.9 million (non-discounted).

We estimate the discounted total cost of the interim rule to vessel owners and facilities to range from $38.9 million to $45.1 million (2005-2014, seven percent and three percent discount rates, respectively). We estimate that fleeting facilities will incur approximately 88 percent of the discounted total cost ($34.3 to $39.8 million). Table 1 presents the discounted total cost of the interim rule by element of compliance.

As shown in Table 1, using the seven percent discount rate, we estimate the cost associated with the increase in NOA submittals for vessels that only carry ammonium nitrate or propylene oxide to be $0.35 million of the total discounted cost of this interim rule. The cost associated with the vessel and facility security requirements is $38.4 million at a seven percent discount rate ($4.1 for vessel security + $34.3 for facility security). Using three percent as the discount rate, we estimated the cost associated with an increase in NOA submittals for vessels that only carry ammonium nitrate or propylene oxide to be $0.41 million, and the cost associated with the vessel and facility security requirements is $44.6 million ($4.8 for vessel security + $39.8 for facility security).

The qualitative benefits in this interim rule are security-related. By adding ammonium nitrate and propylene oxide to the list of CDCs, society will benefit, as the whereabouts of these two dangerous cargoes are tracked and become known. Furthermore, the revision of the CDC definition to include ammonium nitrate and propylene oxide, will provide relevant information about an applicable vessel's cargo and the threat that cargo may pose.

This interim rule will provide security standards for fleeting facilities that handle these two dangerous cargoes. These security standards will increase awareness, communication, and surveillance to reduce the likelihood of theft and unlawful access to fleeting facilities that handle these volatile and dangerous cargoes.

Lastly, this interim rule will allow the Coast Guard to provide greater flexibility for NOA submissions by allowing vessel owners and operators three additional electronic means of NOA submittal.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this rule would have a significant economic impact on a substantial number of small entities. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. This rule does not require a general notice of proposed rulemaking and, therefore, is exempt from the requirements of the Regulatory Flexibility Act. Although this rule is exempt, we have reviewed it for potential economic impacts on small entities.

We expect that this interim rule may have an economic impact on some small entities, as defined by the Small Business Administration. Small entities affected by this rule fall into two groups: (1) Those small entities that currently carry or handle CDCs in addition to ammonium nitrate and ammonium nitrate based fertilizers, in bulk, and propylene oxide, alone or mixed with ethylene oxide, in bulk; and (2) those small entities that currently carry or handle only ammonium nitrate and ammonium nitrate based fertilizers in bulk, and propylene oxide, alone or mixed with ethylene oxide, in bulk.

Small entities in the first category currently submit NOAs and comply with the security measures and planning requirements. These entities will have to submit a greater number of NOAs for the newly covered cargoes. They may have to revise existing security plans and change security measures to cover these cargoes.

Small entities in the second category were affected for the first time by the temporary rule and will continue to comply with NOA requirements in 33 CFR part 160 for shipments of these cargoes and with the security measures and planning requirements in 33 CFR parts 104 and 105.

The Coast Guard is particularly interested in the impact of this rule on small entities. If you are a small entity, we specifically request comments regarding the economic impact of this rule on you.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking. If you think this interim rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult ENS Joseph Azzata, Office of Port Security Planning and Readiness (G-MPP), Coast Guard, telephone 202-267-0069. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

This interim rule does not require a new collection of information (COI) or change to the two existing OMB-approved collections, 1625-0100 and 1625-0077. The current approval for 1625-0100 expires on March 31, 2008. The approval for 1625-0077 expires July 31, 2008.

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. Therefore, in accordance with section 6 of Executive Order 13132, the Coast Guard certifies that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

The Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 or more in any one year. UMRA does not require an assessment in the case of an interim rule issued without prior notice and comment. Nevertheless, the Coast Guard does not expect this interim rule to result in such an expenditure. We discuss this interim rule's effects elsewhere in this preamble.

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g. , specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This interim rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this interim rule under Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, we believe that this rule should be categorically excluded, under figure 2-1, paragraphs (34)(a) and (d), of the Instruction from further environmental documentation. An “Environmental Analysis Check List” and a “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES .

Background and Purpose

Pursuant to 46 U.S.C. 6101 and Coast Guard regulations, U.S. vessel owners are required to report marine casualties to the Coast Guard. Initially there were four categories of marine casualties that required reporting to the Coast Guard: (1) Death of an individual, (2) serious injury to an individual, (3) material loss of property, and (4) material damage affecting the seaworthiness of the vessel. Section 4106 of the Oil Pollution Act of 1990, Public Law 101-380 (OPA 90), amended 46 U.S.C. 6101 to add “significant harm to the environment” to the list of reportable marine casualties. Additionally, section 4106 extended the requirements for reporting a marine casualty involving “material damage affecting the seaworthiness or efficiency of the vessel” or “significant harm to the environment” to any foreign-flag vessel “constructed or adapted to carry, or that carries, oil in bulk as cargo or cargo residue” and operating beyond U.S. navigable waters, but within waters subject to the jurisdiction of the United States (principally, the U.S. Exclusive Economic Zone, or EEZ).

The Coast Guard held a public meeting on January 20, 1995, to solicit public comments regarding the requirements of OPA 90. See 59 FR 65522 (December 20, 1994). Subsequently, the Coast Guard published a notice of proposed rulemaking (NPRM) on November 2, 2000 (65 FR 65808) to solicit comments on amendments to Coast Guard regulations to implement the requirements of OPA 90. The Coast Guard also published a supplemental notice of proposed rulemaking (SNPRM) on July 12, 2001 (66 FR 36530) to solicit comments on federalism issues raised by commenters on the NPRM.

This rule amends Coast Guard regulations as necessary to finalize implementation of the requirements of section 4106 of OPA 90.

The Coast Guard received 25 letters commenting on the NPRM. Nine letters commented on the Federalism analysis set forth in the NPRM. The comments relating to the Federalism analysis of the NPRM have been discussed in the SNPRM and therefore will not be discussed again in this final rule.

General: Nine commenters expressed general support for the NPRM. One commenter said the basic premise that vessels be subject to reporting requirements for incidents through all navigable waters, including the EEZ, is commendable and should improve the government's ability to respond to incidents, and further our understanding of vessel navigation safety. Another commenter “applauded” our regulation of foreign tank vessels operating within U.S. jurisdiction because such regulation would level the playing field for U.S. marine interests. Five other commenters said foreign vessels plying U.S. waters should have to comply with all the same notification requirements as U.S.-flag vessels.

Ballast water: One commenter asked the Coast Guard to revise the proposed text of 33 CFR 151.15(c)(1) by adding the statement that “this provision does not require reporting of normal or emergency discharges of ballast water during shipping operations.” The commenter said such discharges are already covered by 33 CFR part 151, subpart D, and are not normally considered marine casualties. We agree with the commenter that ballast water discharges normally do not constitute marine casualties. However, because nothing in 33 CFR 151.15 amends 33 CFR part 151, subpart D, we see no need to add the requested language.

Industry costs: One commenter said that our estimated burden of response (one hour per form) is not realistic, particularly when the number of people involved in confecting and administering the report form is considered. The estimate of the paperwork burden is an average of the time and resources likely needed to complete and process report forms currently used by industry to collect information about a wide range of casualties with various impacts. In some cases, the form will take longer to complete and involve more than one person, particularly for casualties with extensive impacts. In other cases, it will take less time and involve only one person, particularly for casualties with small or no impacts.

One commenter said that neither the NPRM's discussion of costs generally, nor of small entity costs in particular, addressed the implied new reporting mandates of 46 CFR 4.03-1(b). Title 46 CFR 4.03-1 does not establish new reporting mandates; rather reporting requirements are provided in 46 CFR 4.05. The NPRM proposed new reporting requirements for occurrences involving significant harm to the environment and material damage to foreign tank vessels operating within the EEZ. The NPRM describes the total industry cost and the impact on small entities as the increase in paperwork burden due to the proposed new reporting requirements.

Duplicative reporting: Eleven commenters remarked on what they considered to be duplicative reporting requirements in the NPRM. One commenter saw our proposal as adding to the paperwork burden affecting U.S. waters generally and the Mississippi River system in particular. Four said that submission of casualty reports is a process that needs to be simplified and streamlined, and that our proposal goes in the wrong direction. Two said they had been advised of Coast Guard plans to initiate a rulemaking to reduce the number of written reports required, while a third said that a comprehensive approach to reforming marine casualty reporting standards is long overdue and that tacking additional requirements onto an antiquated reporting regimen distracts the Coast Guard and responsible industry members from efficiently exchanging information needed to protect the marine environment. All three of these commenters asked us to move quickly with these reform efforts. We consider the streamlining of the marine casualty reporting process to be a continuing project that exceeds the scope of the present rulemaking. We disagree that the present rulemaking goes in the wrong direction. Instead, this final rule extends well-established procedures for reporting marine casualties to events involving significant harm to the environment, in line with statutory requirements.

Four commenters said that Coast Guard pollution investigators already record comprehensive amounts of information when executing their response and investigation responsibilities, and asked what possible benefit the Coast Guard could derive from having the responsible party give this information again via a “one size fits all” marine casualty report form like Form CG-2692. We believe the public, the Coast Guard, and the responsible party all benefit from the marine casualty report. The report gives the marine industry a nationally consistent tool for describing an incident accurately and quickly, and in the responsible party's own words. The report is an important and unique component of the investigative file, not a redundancy.

One commenter was concerned that by creating dual reporting and investigative requirements for oil spills under both 33 CFR 151.15 and 153.203 and 46 CFR part 4, we have set up a situation where operators may comply with one of the reporting requirements but not the other, exposing themselves to potential civil penalties. This commenter said we should put the reporting requirements in one section or another, but not in both. We have embedded cross-references in 33 CFR 151.15(g), 33 CFR 153.203, and 46 CFR 4.05-1(c). Notification reports made under 33 CFR 151.15 and 153.203 will satisfy the reporting requirements in 46 CFR 4.05. However, reports made under 46 CFR 4.05 will not satisfy the notification requirements in 33 CFR 151.15 and 153.203, but, if a discharge is reported to us under 46 CFR 4.05, we will notify the party of its reporting responsibilities under 33 CFR 151.15 and 153.203.

One commenter asked us to revise 46 CFR 4.05-1(c) by inserting “and the written requirements specified in 46 CFR 4.05-10” after “immediate notification requirement of this section,” and by adding “and does not involve any other marine casualty as defined in 46 CFR 4.03-1.” The commenter said these changes would more clearly state the intent of the regulation and would eliminate the possibility of redundant initial verbal notification and the unnecessary submission of Form CG-2692. We agree with the commenter that paragraph (c) should apply only if the marine casualty exclusively involves significant harm to the environment, and we have revised paragraph (c) accordingly. We do not agree that a report made under 33 CFR 153.203, 40 CFR 117.21, or 40 CFR 302.6 should satisfy 46 CFR 4.05-10 as well as 4.05-1, because 46 CFR 4.05-10(a) provides for a situation in which immediate notice is given under § 4.05-1, but complete information for the marine casualty report (and its addenda) is not available until later. We want to preserve that two-tiered approach. The existing language of 46 CFR 4.05-10(b) states that, if filed without delay after the occurrence of the marine casualty, the report required by 46 CFR 4.05-10 also suffices as the immediate notification required by 46 CFR 4.05-1.

Existing authority: Two commenters said the Coast Guard already has authority allowing us to require immediate notification of incidents that could threaten the environment. One commenter said that 33 U.S.C. 1321 (b)(5) and (d)(2)(D) provide the Coast Guard with that authority and therefore we do not need to adopt a new rule that raises federalism issues. The other said that OPA 90 does not mandate a redundant, unnecessary, and speculative requirement that overlaps with existing reporting requirements contained in 46 CFR 4.05-1, 49 CFR 176.48, 33 CFR 151.26, 33 CFR 153.203, and 33 CFR 155.1040. We addressed the federalism issues raised by the first commenter in our SNPRM. With respect to 33 U.S.C. 1321, while it does contain requirements similar to those contained in OPA 90 (explaining the overlap with existing regulations noted by the second commenter), this section does not apply to foreign vessels that operate in “waters under U.S. jurisdiction” that are not “navigable waters of the United States.” OPA 90 extends coverage to such vessels.

Great Lakes and internal waters: One commenter asked the Coast Guard to address two questions. First, is a vessel that generally operates on the ocean, but occasionally operates in the Great Lakes or U.S. internal waters, subject to 33 CFR 151.15 on those occasions? Second, is a vessel operating under a foreign authority subject to 33 CFR 151.15 when it operates in the Great Lakes (presumably on the U.S. side of the international boundary) or in U.S. internal waters? We consider the answer to be “yes” in both cases, provided the vessel is not specifically exempted by 33 CFR 151.09(b).

Highways: Two commenters compared the regulation of marine commerce with highway regulations, saying it seems odd that the “most environmentally friendly” transportation system is held under microscopic examination while highway runoff from land based transportation is not. The Coast Guard notes that these comments are outside of the scope of the present rulemaking and beyond the jurisdiction of the Coast Guard's authority. We consider the required report on marine casualties to be essential to the Coast Guard's performance of its statutory duties for the protection of marine safety and the environment.

Inconsistent application: Four commenters complained that inconsistencies among Coast Guard officials in applying the reporting criteria are rampant. These comments are beyond the scope of this rulemaking; however, you can address comments or complaints about how reporting criteria are applied to United States Coast Guard Headquarters (G-MOA), 2100 Second Street, SW., Washington, DC 20593 or by e-mail at fldr-G-MOA@comdt.uscg.mil.

Procedure: One commenter said our proposed changes to 46 CFR 4.03-1(b) added or changed reporting requirements that were not identified in the original meeting notice or in the NPRM, and that were not justified by any discussion of need, goals, or alternatives considered. No reporting requirements were proposed in 46 CFR 4.03-1(b); the new proposed reporting requirements in 46 CFR 4.05 were discussed fully in the NPRM preamble. The NPRM proposed only one substantive change to 46 CFR 4.03-1(b): the addition of paragraph (b)(1)(xii), which adds any incident involving significant harm to the environment. That change also was amply discussed in the NPRM preamble. We also rewrote the section and changed some of the illustrations of events that would constitute a marine casualty or accident, but neither in the former 46 CFR 4.03-1 nor in the new version are these illustrations intended to limit the definition of a marine casualty or accident. It is true that former section 4.03-1 defined a marine casualty or accident to “mean any casualty or accident involving any vessel * * *” while the new version says that the term “applies to events caused by or involving a vessel” * * * However, dictionary definitions of “involving” include “to have an effect on,” so we do not think there is, and did not intend there to be, any substantive difference between the two versions of section 4.03-1 on this count. See Merriam-Webster Online, http://www.m-w.com , last checked on Aug. 19, 2005.

Recreational boaters: Two commenters complained that the regulatory burden imposed on industry by rulemakings like this one is not imposed on recreational boaters who, according to the commenters, do not need to be licensed, do not understand the rules of the road, and have nothing to lose from noncompliance with standards that apply to industry. The present rulemaking applies only to vessels covered by 33 CFR parts 151 and 153, and 46 CFR part 4. To the extent those parts do not apply to recreational boaters, those boaters remain subject to other Federal and State statutory and regulatory controls, including the casualty and accident reporting provisions of 33 CFR part 173.

Requiring other casualties: One commenter said we should amend the rule so that a written report is not required for any actual or potential discharge that does not involve some other marine casualty required to be reported under 46 CFR 4.05-1. We decline to adopt this recommendation because we think it would weaken the apparent intent of OPA 90 to equate “significant harm to the environment” with the other marine casualties listed in 46 U.S.C. 6101(a). In our view, the statute requires a report to be filed when any one of the listed casualties occurs. The requirement is not conditioned upon the presence of multiple events or aggravating factors.

Significant harm: Eight commenters asked for or suggested clarification on the meaning of “significant harm to the environment.” Five said that the Environmental Protection Agency's definition of significant harm (40 CFR 110.3) is neither reasonable nor appropriate for marine casualty considerations. These five said it is unreasonable that sheen coming from a properly greased but broken rudder stock would meet our proposed definition, as would an eyedropper discharge of diesel fuel or a drop of oil from a $20 hydraulic steering hose rupture, or any small amount of oil from a commercial source, but that the release of 4,999 lbs. of ammonium sulfate would not meet the definition. We believe 46 CFR 4.03-65 adequately and appropriately defines significant harm to the environment by referencing 40 CFR 110.3 and other existing regulations. The significance of an environmental marine casualty is not necessarily a function of the quantities discharged or of the reasons for the discharge. Information about the causes of a discharge, or measures taken to prevent or abate the discharge, can be given in the marine casualty report itself. Whether discharge of small amounts of ammonium sulfate should also constitute an environmental marine casualty is beyond the scope of this rulemaking.

Three commenters said the NPRM was directly inconsistent with recent Coast Guard initiatives to better align marine casualty investigation and reporting procedures with legitimate marine safety goals and with a Coast Guard policy against investigating minor incidents where reports provide little or no useful information for improving marine safety. We see no inconsistency. This rule aligns existing regulations with OPA 90's inclusion of significant harm to the environment in the list of reportable marine casualties under 46 U.S.C. 6101(a). This rule does not alter the Coast Guard's processing of marine casualty reports or our procedures for determining which reported marine casualties will be investigated.

One commenter said it will report all discharges or probable discharges, but that to require written reports for minor matters will be counterproductive to practical considerations and will not result in any meaningful protection of the environment. It may be that not all marine casualty reports will result in meaningful safety improvements, but reporting requirements are well established and help insure the timely availability of information that may prove critical, either to immediate response efforts or to longer term marine safety programs. This final rule simply extends those established requirements to environmental marine casualties.

One commenter said the Coast Guard should align the definition of “significant harm to the environment” with our existing definition of a major oil spill or chemical release, in lieu of any violation of the Clean Water Act. We note that amended 46 CFR 4.03-65 is aligned with several existing definitions of prohibited discharge. The amended regulation refers to the definition of harmful oil discharges in 40 CFR 110.3, to rules for determining reportable quantities of hazardous substances in 40 CFR part 117, to oil discharge limitations in 33 CFR 151.10 and 33 CFR 151.13, and to noxious liquid substance discharge limitations in 46 CFR 153.1126 and 153.1128.

One commenter suggested amending proposed 33 CFR 151.15(c)(1) by inserting “as set forth in 40 CFR 110.3” after “[a] discharge of oil,” and by inserting “in quantities equal to or exceeding, in any 24-hour period, the reportable quantity determined in 40 CFR part 117” after “hazardous substances.” Reports under § 151.15(c)(1) are required only when a discharge results from damage to the vessel (or its equipment), or from efforts to secure vessel safety or save a life at sea. The Coast Guard understands that under such emergency conditions, which may pose an imminent risk to vessel safety and human life, vessel personnel may be unable to devote their primary attention to avoidance or mitigation of environmental damage. However, precisely because these circumstances can give way to unintended environmental consequences, we think it is important to require reports even though the discharge may not rise to the levels specified in 40 CFR 110.3 or 40 CFR part 117.

Executive Order 12866, “Regulatory Planning and Review”, 58 FR 51735, October 4, 1993, requires a determination whether a regulatory action is “significant” and therefore subject to review by the Office of Management and Budget (OMB) and subject to the requirements of the Executive Order. This final rule is considered to be a “significant regulatory action” under Executive Order 12866. Accordingly, this final rule has been reviewed by OMB.

The following is a discussion of the expected costs and benefits of the rule.

We estimate that the rule imposes an additional 1,570 hours per year of annual paperwork requirements on the domestic industry. These paperwork requirements are further discussed under the collection-of-information section. Assuming one hour of staff time has a value of $45, an additional 1,570 hours equates to an aggregate domestic industry cost of $70,650 per year. Additionally, this rule will require an estimated 186 hours of annual paperwork requirements on foreign industry equating to $8,370. The total cost to industry, domestic and foreign, is estimated to be $79,020 annually for a total of 1,756 hours per year.

The measures in this rule are mandated by OPA 90. The primary benefit of this rule is the establishment of standardized reporting requirements that address the Coast Guard's need to track and investigate events that cause “significant harm to the environment.”

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

The estimated annual impact to U.S. industry of this rule is $70,650. The measures included in this proposed rule are mandated by OPA 90. Small entities involved in “significant harm to the environment” incidents will be required to prepare a form which will take approximately one hour of staff time to complete. One hour of staff time is valued at $45. Therefore, the cost per incident of this rule is $45. If a small entity is not involved in a “significant harm to the environment” incident, this rule will have zero cost.

Therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

Under § 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), the Coast Guard wants to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. The NPRM provided small businesses, organizations or governmental jurisdictions a Coast Guard contact to ask questions concerning this rule's provisions or options for compliance. We received no public comments in response to the NPRM regarding any impact on small entities. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please consult Lieutenant Commander Kelly Post, Project Manager, Office of Investigation and Analysis (G-MOA), Coast Guard, telephone 202-267-1418. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

This rule calls for a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5 CFR 1320.3(c), “collection of information” comprises reporting, recordkeeping, monitoring, posting, labeling, and other similar actions. The title and description of the information collections, a description of those who must collect the information, and an estimate of the total annual burden follow. The estimate covers the time for reviewing instructions, searching existing sources of data, gathering and maintaining the data needed, and completing and reviewing the collection.

This rule modifies an existing OMB-approved collection 1625-0001. A summary of the revised collection follows.

OMB Control Number: 1625-0001 [formerly 2115-0003].

Title: Marine Casualty Information & Periodic Chemical Drug and Alcohol Testing of Commercial Vessel Personnel.

Summary of the Collection of Information: The Marine Casualty Information portion of this Collection of Information requires foreign-flag tank vessels operating in the U.S. EEZ to report a marine casualty involving either “significant harm to the environment” or material damage affecting the seaworthiness or efficiency of a vessel. This collection also requires U.S.-flag vessels operating anywhere to report a marine casualty involving “significant harm to the environment”.

Need for Information: To help the Coast Guard track and investigate marine casualties that may result in significant harm to the environment, and lessen the effects by requiring timely notification needed to ensure a timely and appropriate pollution response clean-up.

Proposed Use of Information: Assist the Coast Guard's efforts to track and help determine the level of investigation needed for reportable marine casualties that may result in significant harm to the environment.

Description of the Respondents: All U.S.-flag vessel operators anywhere, or foreign-flag vessels in the navigable waters of the U.S., involved in a marine casualty involving an actual or probable discharge of oil, hazardous substances, marine pollutants, or noxious liquid substances, as well as foreign-flag tank vessels operating within the EEZ that are involved in a marine casualty resulting in either material damage affecting the seaworthiness or efficiency of the vessel or “significant harm to the environment” within the EEZ.

Number of Respondents: The total number of casualty events used to determine the change in annual paperwork requirements for this rule for both U.S.-flag vessels and foreign-flag tank vessels is 1,756. This number represents the 5-year average of U.S. flag-vessels pollution events (1,570) during the years 1993 through 1997 plus the 5-year average of marine casualty events for foreign-flag tank vessels operating in U.S. navigable waters, including the EEZ, of 186 events. The information was retrieved from the U.S. Coast Guard Marine Safety Management System Data Base. The existing OMB-approved number of respondents is 33,189. This rule will increase the number by 1,756. With this rule's submission we are also taking into account a program change of removing the Management Information System (MIS) respondents of 830 (See Chemical Testing final rule; USCG 2003-16414; February 11, 2004; 69 FR 6575). The total number of respondents is 34,115.

Frequency of Response: This rule will change existing reporting requirements by adding reports of “significant harm to the environment” incidents involving U.S.-flag vessels or marine casualty incidents involving foreign-flag tank vessels involved in a marine casualty resulting in material damage affecting the seaworthiness of the vessel or significant harm to the environment in waters subject to the jurisdiction of the U.S. including the EEZ. The existing OMB-approved number of responses is 181,089. This rule will increase the number by 1,756. With this rule's submission we are also taking into account a program change of removing the MIS responses of 830. The total number of responses is 182,015.

Burden of Response: Approximately one hour per form.

Estimated Total Annual Burden: The existing OMB-approved annual burden is 19,195 hours. This rule will increase the number by 1,756 hours. With this rule's submission we are also taking into account a program change of removing the MIS annual burden of 2,075 hours. The total annual burden is 18,876 hours.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), we have submitted a copy of this rule to the Office of Management and Budget (OMB) for its review of the collection of information. OMB has approved the collection. The section numbers are 33 CFR 151.15, 153.203 and 46 CFR 4.05-1. The corresponding approval number from OMB is OMB Control Number 1625-0001 [formerly 2115-0003].

You are not required to respond to a collection of information unless it displays a currently valid OMB control number.

A rule has implications for federalism under Executive Order 13132 if the rule has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. The law is well settled that States may not regulate in categories reserved for regulation by the Coast Guard. The law also is well settled that all of the categories covered in 46 U.S.C. 3306, 3703, 6101, 7101 and 8101 (design, construction, alteration, repair, maintenance, operation, equipping, personnel certification, manning and the reporting of marine casualties on vessels), and any other category in which Congress intended the Coast Guard to be the sole source of a vessel's obligations, are within the field foreclosed from regulation by the States. See United States v. Locke and Intertanko v. Locke , 529 U.S. 89, 120 S.Ct. 1135 (2000)). This final rule concerns the reporting of marine casualties, including the reporting of casualties causing significant harm to the marine environment. Because States may not regulate within this category, preemption under Executive Order 13132 is not an issue.

However, the determination that States are precluded from regulating in the category of marine casualty reporting does not impact the ability of a State to require reports of the discharge, or the substantial threat of a discharge of oil. Pursuant to Section 1018 of OPA 90, States retain their rights to impose additional requirements regarding reports of the discharge or substantial threat of a discharge of oil for the purpose of responding to the discharge or substantial threat of a discharge and instituting liability and compensation proceedings, providing those requirements do not touch on preempted categories described in the Locke decision. Therefore, present and future State discharge reporting requirements that do not touch on the preemptive marine casualty reporting category are unaffected by the Locke decision and this rule, so in that regard, this rule likewise has no implications for federalism.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, requires Federal agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector of more than $100 million in any one year (adjusted for inflation with 1995 base year). Before promulgating a rule for which a written statement is needed, section 205 of UMRA requires an agency to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome option that achieves the objective of the rule. Section 205 allows an agency to adopt an alternative, other than the least costly, most cost-effective, or least burdensome option if the agency publishes an explanation with the final rule.

This final rule will not result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector of more than $100 million in any one year. Therefore, the Coast Guard has not prepared a written assessment under UMRA.

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This final rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We considered the environmental impact of this final rule and concluded that, under figure 2-1, paragraph (34)(a), of Commandant Instruction M16475.1D, this final rule is categorically excluded from further environmental documentation. This rule will add a requirement to report marine casualties involving “significant harm to the environment” and for foreign flag tank vessels operating in waters subject to U.S. jurisdiction but beyond U.S. navigable waters to report material damage affecting the seaworthiness or efficiency of the vessel. A “Categorical Exclusion Determination” is available in the docket where indicated under ADDRESSES .

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Due to the immediate need for the protection of the maritime public, it is impracticable to publish a NPRM in advance. Thus, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Any delay in implementing this rule would be contrary to public interest since immediate action is needed to prevent vessels carrying petroleum products as cargo with a loaded draft of greater than five feet from transiting the area so as to avoid the potential hazards associated with a grounding of a vessel.

East Rockaway Inlet has experienced significant shoaling causing the channel to migrate towards the west. Water depths in the federal navigation channel have been reduced in some areas to as low as 5 feet. This channel was last dredged by the Army Corps of Engineers during the winter of 2004/2005. However, the shoaling in this area has reduced depths to a point where transit for vessels drawing greater than five feet increases the immediate risk of grounding. Therefore, the Coast Guard is relocating the channel buoys to the west to account for channel migration. The delay inherent in the NPRM process is contrary to the public interest and impracticable, as urgent action is needed to minimize the potential danger posed by the possibility of groundings of tankers and the potential resultant oil spills in and around this regulated navigation area. The effective period of this regulation will provide the Coast Guard with the necessary time to conduct notice and comment rulemaking in order to establish a permanent regulated navigation area in East Rockaway Inlet.

East Rockaway Inlet is on the South Shore of Long Island, in Nassau County, New York. The Inlet has experienced significant shoaling since dredging was completed in the late winter of 2004/2005, causing the channel to migrate towards the west. Water depths in the federal navigation channel have been reduced in some areas to as low as 5 feet. This channel was last dredged by the Army Corps of Engineers during the winter of 2004/2005. The channel buoys are being relocated to the west to account for channel migration. East Rockaway Inlet is frequented by small coastal tankers and tugs towing oil barges supplying two facilities: Sprague Energy Oceanside, located in Oceanside, Long Island, New York, a supplier of home heating oil for Long Island, New York, and Keyspan E.S. Barrett, an electrical power generation facility, located in Island Park, Long Island, New York. The shoaling in this area has reduced depths to a point where transit for vessels drawing greater than five feet increases the risk of immediate grounding, and the potential for a significant oil spill. Similar shoaling led to the grounding in late 2003 and in 2004 of small coastal tankers carrying home heating oil.

This rule will provide for the safety of vessel traffic in and around East Rockaway Inlet, Long Island, New York. This regulation establishes a temporary regulated navigation area (RNA) on the navigable waters of the East Rockaway Inlet in an area bounded by lines drawn from the approximate position of the Silver Point breakwater buoy (LLN 31500) at 40°34′56″ N, 073°45′19″ W, running north to a point of land on the northwest side of the inlet at position 40°35′28″ N, 073°46′12″ W, thence easterly along the shore to the east side of the Atlantic Beach Bridge, State Route 878, over East Rockaway Inlet, thence across said bridge to the south side of East Rockaway Inlet, thence westerly along the shore and across the water to the beginning. The rule described herein prohibits the transit of vessels carrying petroleum products as cargo with a loaded draft greater than five feet through the RNA. Operators of vessels carrying petroleum products as cargo with a loaded draft greater than five feet may submit a request to transit the regulated navigation area. The request must consist of a voyage plan that identifies acceptable parameters for transiting the RNA to the Captain of the Port, Long Island Sound. Parameters addressed shall include: Weather conditions for transit, restrictions due to state of tide, the loaded draft of the vessel, and minimum under keel clearance. The required general voyage plan must be submitted at least 48 hours prior to the vessel's first transit through the RNA. Vessels may only transit the RNA after receiving approval of the submitted voyage plan. This request and voyage plan need only be submitted one time for vessels operating in accordance with the approved plan. Vessel operators must submit any modifications, and receive approval thereof, from the Captain of the Port, Long Island Sound of any modifications to the approved voyage plan prior to transiting the RNA. Modifications to approved plans must be submitted to the COTP LIS at least 24 hours prior to the transit to which the modification applies. This RNA is in effect from 6 a.m. on November 29, 2005 until 11:59 p.m. on May 31, 2006.

Any violation of the RNA described herein, is punishable by, among others, civil and criminal penalties, in rem liability against the offending vessel, and license sanctions.

The Captain of the Port Long Island Sound will notify the maritime community of the requirements of this regulated navigation area via broadcast notifications and notifications in the local notice to mariners.

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

We expect the economic impact of this rule will be so minimal that a full Regulatory Evaluation under the regulatory policies and procedures of DHS is unnecessary. This regulation may have some impact on the public, but the potential impact will be minimized for the following reasons: The regulated navigation area limits only vessels carrying petroleum products as cargo with a loaded draft of greater than five feet; operators of vessels with a loaded draft of greater than five feet may request permission to transit the regulated navigation area from the Captain of the Port, Long Island Sound. Recreational and other maritime traffic is not prohibited from transiting this area.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels carrying petroleum products intending to transit or anchor in those portions of the East Rockaway Inlet covered by the regulated navigation area; and Sprague Energy Oceanside, located in Oceanside, Long Island, New York, a supplier of home heating oil, and Keyspan E.S. Barrett, an electrical power generation facility, located in Island Park, Long Island, New York, which receive the vessels affected by this regulated navigation area. For the reasons outlined in the Regulatory Evaluation section above, this rule will not have a significant impact on a substantial number of small entities.

If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES ) explaining why you think it qualifies and how and to what degree this rule would economically affect it.

Under subsection 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 [Pub. L. 104-121], the Coast Guard wants to assist small entities in understanding this rule so that they can better evaluate its effects on them and participate in the rulemaking process. If this rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call Lieutenant A. Logman, Chief, Waterways Management Division, Coast Guard Sector Long Island Sound, at (203) 468-4429.

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

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

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

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

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

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

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

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

To help the Coast Guard establish regular and meaningful consultation and collaboration with Indian and Alaskan Native tribes, we published a notice in the Federal Register (66 FR 36361, July 11, 2001) requesting comments on how to best carry out the Order. We invite your comments on how this rule might impact tribal governments, even if that impact may not constitute a “tribal implication” under the Order.

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies.

This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

The Coast Guard analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that there are no factors in this case that would limit the use of a categorical exclusion under section 2.B.2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2-1, paragraph (34)(g) from further environmental documentation. This rule fits the category selected from paragraph (34)(g), as it establishes a safety zone. An Environmental Analysis Checklist and Categorical Exclusion Determination are available for review at the location listed under ADDRESSES .

In title 40 of the Code of Federal Regulations, Part 60 (§ 60.1 to End), revised as of July 1, 2005, on page 167, in § 60.41c, correct the definition of “Annual capacity factor” to read as follows:

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

• Crop production (NAICS 111).

• Animal production (NAICS 112).

• Food manufacturing (NAICS 311).

• Pesticide manufacturing (NAICS 32532).

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

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ . To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http://www.epa.gpo/opptsfrs/home/guidelin.htm/.

In the Federal Register of June 22, 2004 (69 FR 31116) (FRL-7357-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 4E6831) by Syngenta Crop Protection, Inc., P.O. Box 18300, Greensboro, North Carolina, 27419-8300. This notice included a summary of the petition prepared by Syngenta Crop Protection, Inc., the petitioner. The petition requested that 40 CFR 180.560 for combined residues of the inert ingredient herbicide safener acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester and its acid metabolite (5-chloro-8-quinolinoxyacetic acid) be amended by:

1. Increasing the tolerance expressions in or on wheat, forage to 0.20 ppm and wheat, hay to 0.50 ppm,

2. Adding tolerance expressions for barley, grain, hay and straw at 0.10 ppm, and

3. By adding a reference to the active ingredient pinoxaden.

For ease of reading this document, acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester will be referred to as cloquintocet-mexyl. The Chemical Abstracts Service (CAS) Registry Number of cloquintocet-mexyl is 99607-70-2 and the CAS name is acetic acid, [(5-chloro-8-quinolinyl) oxy]-, 1-methylhexyl ester (9 CI).

One comment was received on the notice of filing from a private citizen questioning whether the Agency was going to use the most current and up-to-date information and data available when writing the final rule. In developing the final rule, EPA did evaluate the information and data submitted by the petitioner as well as more recent information that was available to the Agency.

In the final rule that EPA used to establish the existing tolerances under 40 CFR 180.560 ( Federal Register of June 22, 2000 (65 FR 38757; FRL-6592-4; PP7E4920), EPA determined that additional data (for plant and livestock metabolism, plant analytical methods, multiresidue methods, storage stability, crop field trials, processing studies, and rotational crops) were required before a permanent registration for cloquintocet-mexyl in or on wheat commodities could be established. Syngenta submitted data in response to the previous risk assessment. Assessments of human exposures and risks were conducted for acute and chronic dietary risk, exposure and risk to cloquintocet-mexyl residues in water, residential exposure and risk, aggregate risk, and exposure and risk to workers.

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

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see http://www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm .

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. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408(b)(2) of FFDCA, for a tolerance for combined residues of cloquintocet-mexyl and its acid metabolite on wheat, grain and straw at 0.10 ppm; wheat, forage at 0.20 ppm; wheat, hay at 0.50 ppm; barley, grain at 0.01 ppm; and barley, hay and straw at 0.10 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. Specific information on the studies received and the nature of the toxic effects caused by cloquintocet-mexyl as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are described in this section.

1. Acute toxicity . The acute toxicity data (see Table 1) indicated that cloquintocet-mexyl (CGA 185072) has low acute oral, dermal, and inhalation toxicity (Acute Toxicity Category III) and is slightly irritating to eyes. It is not a skin irritant. However, it is a skin sensitizer.

2. Subchronic and chronic toxicity . Available toxicity studies are described in Table 2.

i. Systemic toxicity . The primary target organs for subchronic exposure of cloquintocet-mexyl (CGA 185072) are the liver and the renal system. In a 90-day feeding study in rats, increased incidence of urinary bladder hyperplasia and increased serum bilirubin were observed in males at doses ≥ 1,000 ppm (equivalent to 64 mg/kg/day). This observation was supported by a 28-day oral gavage study in rats where renal papillary necrosis and inflammation with fibrosis were observed at doses ≥ 100 mg/kg/day. In a 28-day dermal toxicity study in rats, mottled or reddish livers accompanied by histopathological changes including necrosis and fibrosis were observed in two of five females exposed to 1,000 mg/kg/day of cloquintocet-mexyl (CGA 185072). In a 90-day feeding study in dogs, liver toxicity was evidenced by observations of liver necrosis and perivascular inflammatory cell infiltration. In the one-year dog study, increased relative liver weight and increased chronic interstitial nephritis were observed. It is notable that in the two-year chronic toxicity study in rats, no renal or liver toxicity was reported; however, there was an increase in lymphoid hyperplasia of the thymus in male rats and an increase in thyroid follicular epithelial hyperplasia in female rats at 73 mg/kg/day.

ii. Developmental/reproductive toxicity . There was no evidence of developmental or reproductive toxicity for cloquintocet-mexyl. The data demonstrate no increased sensitivity of rats or rabbits to in utero or early post-natal exposure to cloquintocet-mexyl (CGA 185072). NOAELs for maternal/parental toxicity were either less than or equal to the NOAELs for fetal or reproductive toxicity.

iii. Carcinogenicity . In accordance with the EPA Proposed EPA Weight-of-the-Evidence Categories , August 1999 cloquintocet-mexyl was classified as not likely to be a human carcinogen. Carcinogenicity studies in rats and mice did not show increased incidence of spontaneous tumor formation. With negative mutagenic test battery, it is suggested that cloquintocet-mexyl (CGA 185072) is not likely to be a human carcinogen.

iv. Mutagenicity . Studies indicate that cloquintocet-mexyl is not mutagenic in bacteria ( Salmonella typhimurium or Escherichia coli ) or cultured mammalian cells (Chinese hamster V79 lung fibroblasts). There is also no evidence of clastogenicity either in vitro or in vivo . Similarly, cloquintocet-mexyl did not induce unscheduled DNA synthesis (UDS) in primary rat hepatocytes.

v. Neurotoxicity . There is no evidence of neurotoxicity based on observations in toxicity studies. Acute and subchronic neurotoxicity studies are not available for cloquintocet-mexyl; additional neurotoxicity testing is not being required at this time.

vi. Metabolism . Metabolism studies in rats indicated that approximately 40% of the administered dose of cloquintocet-mexyl was absorbed through the gastrointestinal tract and subsequently excreted via the urine. Fecal excretion accounted for approximately 60% of the administered dose. The chemical was rapidly eliminated (more than 80% of the administered dose) via feces and urine within 48 hours post-dosing. Sex, dosing regime, and dose levels had little effect on the excretion pattern. Excretion patterns were similar between the biliary cannulated and non-cannulated animals indicating that there was no enterohepatic circulation of the chemical. Three days after administration, tissue radioactivity accounted for less than 0.3% of the administered dose (or was non-detectable) and was not detectable in the expired air. At day three post-dosing, most tissue residues of radioactivity were below the limit of detection. The major metabolic pathway of cloquintocet-mexyl was ester hydrolysis to yield 5-chloro-8-quinolinoxy acetic acid, the major metabolite in the fecal and urinary pools.

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

• Crop production (NAICS code 111)

• Animal production (NAICS code 112)

• Food manufacturing (NAICS code 311)

• Pesticide manufacturing (NAICS code 32532)

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

In addition to using EDOCKET (http://www.epa.gov/edocket/) , you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 180 is available on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/ .

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is establishing tolerances for combined residues of the miticide bifenazate, 1-methylethyl-2-(4-methoxy[1,1'-biphenyl]-3-yl hydrazinecarboxylate) and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester, expressed as bifenazate, in or on tart cherries at 5.0 parts per million (ppm); soybean seed at 1.5 ppm; soybean hulls at 20 ppm; soybean meal at 3.5 ppm; and soybean refined oil at 20 ppm. These tolerances will expire and are revoked on December 31, 2009. EPA will publish a document in the Federal Register to remove the revoked tolerances from the Code of Federal Regulations.

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

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

Section 18 of the FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” This provision was not amended by the Food Quality Protection Act of 1996 (FQPA). EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The state of Utah petitioned EPA to allow use of bifenazate on tart cherries to control phytophagous spider mites. EPA has determined that Utah tart cherry growers are likely to suffer significant economic losses due to pest infestation without use of bifenazate. Data submitted indicate that effective control has not been achieved using current registered products. In addition, the primary pesticide used for mite control in the past, propargite, has been relabeled for post-harvest use only. Bifenazate is necessary to prevent crop losses in the current year and to ensure tree vitality in the next year.

In a separate action, the state of Delaware petitioned EPA to allow use of bifenazate on soybeans to control two spotted spider mites. According to the applicant, there are two registered products, dimethoate and chlorpyrifos, which have some miticidal activity and are recommended for spider mite control in Delaware soybeans. EPA has determined that, in the event of hot, dry weather, mite populations could cause significant economic losses to soybean growers in Delaware, even in light of these alternatives.

EPA determined that bifenazate can be used with a reasonable certainty of no harm to humans or to the environment. Thus, EPA has authorized under FIFRA section 18 the use of bifenazate on tart cherries for control of phytophagous spider mites in Utah, and on soybeans for control of two spotted spider mites in Delaware. After having reviewed the submission, EPA concurs that emergency conditions exist for this State.

As part of its assessment of this emergency exemption, EPA assessed the potential risks presented by residues of bifenazate in or on tart cherries and soybeans. In doing so, EPA considered the safety standard in section 408(b)(2) of the FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of the FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of the FFDCA. Although these tolerances will expire and are revoked on December 31, 2009, under section 408(l)(5) of the FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on tart cherries and soybeans after that date will not be unlawful, provided the pesticide is applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these tolerances at the time of that application. EPA will take action to revoke these tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

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

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

Consistent with section 408(b)(2)(D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of bifenazate and to make a determination on aggregate exposure, consistent with section 408(b)(2) of the FFDCA, for a time-limited tolerance for combined residues of bifenazate in or on tart cherries at 5.0 ppm; soybean seed at 1.5 ppm; soybean hulls at 20 ppm; soybean meal at 3.5 ppm; and soybean refined oil at 20 ppm. EPA's assessment of the dietary exposures and risks associated with establishing the tolerance follows.

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

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

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

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

1. Dietary exposure from food and feed uses. Tolerances have been established (40 CFR 180.572) for the combined residues of bifenazate, in or on a variety of raw agricultural commodities. Tolerances on primary crops range from 0.1 ppm to 35 ppm on pome fruit, fruiting vegetable, cucurbit vegetable, tree nut, nectarine, peach, plum, grape, strawberry, cotton, hops, okra, peppermint, and spearmint. Tolerances have also been established in milk, ruminant meat, and ruminant meat byproducts at 0.02 ppm. Bifenazate is a selective miticide which controls the motile stage of mites either by direct contact or through contact with foliar residues. Risk assessments were conducted by EPA to assess dietary exposures from bifenazate in food as follows:

i. Acute exposure . Acute dietary risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. As indicated in Table 1 above, toxicological data for bifenazate do not identify any dose to the chemical which triggers a toxic effect based on an acute dose. As there were no toxic effects attributable to a single dose, an endpoint of concern was not identified to quantitate acute-dietary risk to the general population, to infants, to children or to the subpopulation females 13-50 years old. Therefore, there is no acute reference dose (aRfD) or acute population-adjusted dose (aPAD) for the general population or females 13-50 years old. An acute aggregate risk assessment was not performed because no acute risk is expected.

ii. Chronic exposure . In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model (DEEM TM ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994-1996 and 1998 nationwide Continuing Surveys of Food Intake by Individuals (CSFII) and accumulated exposure to the chemical for each commodity.

The chronic dietary exposure analysis was based on tolerance level residues excluding tomato and soybean (average field trial residues was assumed for these crops) and average percent crop treated information. DEEM TM (Version 7.76) default processing factors were used for some commodities. The analyses also included the chronic surface water point estimate generated using the Tier 1 model First Index Reservoir Screening Tool (FIRST) which assumed that 87% of the basin is cropped and 100% of the cropped area treated at the maximum rate (surface water chronic point estimate was greater than the ground water point estimate).

iii. Cancer . Bifenazate has been classified as “not likely” to be a human carcinogen.

iv. Anticipated residue and percent crop treated (PCT) information . Section 408(b)(2)(E) of the FFDCA 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 pursuant to section 408(f)(1) 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. For the present action, EPA will issue such Data Call-Ins for information relating to anticipated residues as is required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Such Data Call-Ins will be required to be submitted no later than 5 years from the date of issuance of this tolerance.

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

The Agency used average PCT information for several commodities.

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 bifenazate may be applied in a particular area.

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

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

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

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

Based on the FIRST and SCI-GROW models the EECs of bifenazate for chronic exposures are estimated to be 6.4 parts per billion (ppb) for surface water and < 0.001 ppb for ground water.

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

Bifenazate is currently registered for use on the following residential non-dietary sites: Ornamentals and non-bearing fruit trees. The risk assessment was conducted using the following exposure assumptions: Only short-term dermal and short-term inhalation exposure are expected for homeowner applicators. Post-application exposure is anticipated to be negligible and was not assessed.

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to bifenazate and any other substances and bifenazate 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 bifenazate has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.

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

You may be affected by this action if you manufacture (defined by statute at 15 U.S.C. 2602(7) to include import) chemical substances, including inorganic chemical substances, subject to reporting under the Inventory Update Rule (IUR) at 40 CFR part 710. Any use of the term “manufacture” in this document will encompass import, unless otherwise stated.

Potentially affected entities may include, but are not limited to:

Chemical manufacturers and importers subject to IUR reporting, including chemical manufacturers and importers of inorganic chemical substances (NAICS codes 325, 32411).

This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. To determine whether you or your business may be affected by this action, you should carefully examine the applicability provisions at 40 CFR 710.48. If you have any questions regarding the applicability of this action to a particular entity, consult the technical contact person listed under FOR FURTHER INFORMATION CONTACT .

In addition to using EDOCKET ( http://www.epa.gov/edocket/ ), you may access this Federal Register document electronically through the EPA Internet under the “ Federal Register ” listings at http://www.epa.gov/fedrgstr/ . A frequently updated electronic version of 40 CFR part 710 is available at E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr /.

1. Submitting CBI . Do not submit confidential business information (CBI) to EPA through EDOCKET, regulations.gov, or e-mail. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as CBI and then identify electronically within the disk or CD ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments . When submitting comments, remember to:

i. Identify the rulemaking by docket ID number and other identifying information (subject heading, Federal Register date, and page number).

ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.

iii. Explain why you agree or disagree; suggest alternatives, and substitute language for your requested changes.

iv. Describe any assumptions and provide any technical information and/or data that you used.

v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.

vi. Provide specific examples to illustrate your concerns, and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

EPA is required under TSCA section 8(b), 15 U.S.C. 2607(b), to compile and keep current an inventory of chemical substances manufactured or processed in the United States. This inventory is known as the TSCA Chemical Substances Inventory (the TSCA Inventory). In 1977, EPA promulgated a rule (42 FR 64572, December 23, 1977) under TSCA section 8(a), 15 U.S.C. 2607(a), to compile an inventory of chemical substances in commerce at that time. In 1986, EPA promulgated the initial IUR regulation under TSCA section 8(a) at 40 CFR part 710 (51 FR 21438, June 12, 1986) to facilitate the periodic updating of the TSCA Inventory and to support activities associated with the implementation of TSCA. In 2003, EPA promulgated extensive amendments to the IUR regulation (68 FR 848, January 7, 2003) (FRL-6767-4) (2003 Amendments) to collect manufacturing, processing, and use exposure-related information, and to make certain other changes. Minor corrections to the IUR regulation were made in July of 2004 (69 FR 40787, July 7, 2004) (FRL-7332-3).

TSCA section 8(a)(1) authorizes the EPA Administrator to promulgate rules under which manufacturers and processors of chemical substances and mixtures (referred to hereinafter as chemical substances) must maintain such records and submit such information as the Administrator may reasonably require. TSCA section 8(a) generally excludes small manufacturers and processors of chemical substances from the reporting requirements established in TSCA section 8(a). However, EPA is authorized by TSCA section 8(a)(3) to require TSCA section 8(a) reporting from small manufacturers and processors with respect to any chemical substance that is the subject of a rule proposed or promulgated under TSCA section 4, 5(b)(4), or 6, or that is the subject of an order under TSCA section 5(e), or that is the subject of relief that has been granted pursuant to a civil action under TSCA section 5 or 7. The standard for determining whether an entity qualifies as a small manufacturer for purposes of 40 CFR part 710 generally is defined in 40 CFR 704.3. Processors are not currently subject to the regulations at 40 CFR part 710.

The data reported under the IUR regulation are used to update the information maintained on the TSCA Inventory. EPA uses the TSCA Inventory and data reported under the IUR regulation to support many TSCA-related activities and to provide overall support for a number of EPA and other Federal health, safety, and environmental protection activities. The IUR regulation, as amended by the 2003 Amendments, requires U.S. manufacturers (including importers) of chemicals listed on the TSCA Inventory to report to EPA every 4 years the identity of chemical substances manufactured for a commercial purpose during the reporting year in quantities of 25,000 pounds or more at any single site they own or control. The IUR regulation generally excludes several categories of substances from its reporting requirements, i.e., polymers, microorganisms, naturally occurring chemical substances, and certain natural gas substances. Sites are required to report information such as company name, site location and other identifying information, identity and production volume of the reportable chemical substance, and manufacturing exposure-related information associated with each reportable chemical substance, including the physical form and maximum concentration of the chemical substance and the number of potentially exposed workers.

Manufacturers (including importers) of larger volume chemicals (i.e., 300,000 lbs. or more manufactured during the reporting year at any site) are additionally required to report certain processing and use information (40 CFR 710.52(c)(4)). This information includes process or use category, NAICS code, industrial function category, percent production volume associated with each process or use category, number of use sites, number of potentially exposed workers, and consumer/commercial information such as use category, use in or on products intended for use by children, and maximum concentration.

For the 2006 submission period, inorganic chemicals, regardless of production volume, are partially exempt (i.e., submitters do not report the processing and use information listed in 40 CFR 710.52(c)(4)). After the 2006 reporting period, the partial exemption for inorganic chemicals will no longer be applicable and submitters will report all information on inorganic chemical substances. In addition, specifically listed petroleum process streams and other specifically listed chemical substances are partially exempt, and manufacturers of such substances are not required to report processing and use information during the 2006 submission period as well as subsequent submission periods.

The 2003 Amendments established a partial exemption in 40 CFR 710.46(b)(2) for certain chemicals for which EPA has determined that the IUR processing and use information is of “low current interest.” The current list of chemical substances which are subject to the low current interest exemption are identified at 40 CFR 710.46(b)(2)(iv). Persons who manufacture or import chemical substances listed in 40 CFR 710.46(b)(2)(iv) are not required to report the processing and use information specified in 40 CFR 710.52(c)(4), but are required to comply with all other reporting obligations. The public may petition EPA to add a substance to, or delete a substance from, the list of chemicals partially exempt from reporting under 40 CFR 710.46(b)(2).

In determining whether the partial exemption should apply to a particular chemical substance, EPA will consider the totality of information available for the chemical substance in question, including but not limited to information associated with one or more of the following considerations (see 40 CFR 710.46(b)(2)(ii)):

It is important to note that the addition of a chemical substance to the partial exemption list will not necessarily be based on the potential risks of the chemical, but on the Agency's current assessment of the need for collecting IUR processing and use information for that chemical, based upon the totality of information considered during the petition review process. Additionally, interest in a chemical or a chemical's processing and use information may increase in the future, at which time EPA will reconsider the applicability of this partial exemption for those chemicals.

A petition to amend the list of chemicals partially exempt from reporting under 40 CFR 710.46(b)(2) (whether by adding or removing a chemical to or from the list) must be in writing, must identify the chemical in question, including a chemical identification number, and should provide sufficient information for EPA to determine whether collection of the information in § 710.52(c)(4) for the chemical in question is of low interest. In an earlier Federal Register document (70 FR 3658, January 26, 2005) (FRL-7332-2), EPA proposed to further amend the IUR regulations to clarify the petition requirements. In that document, EPA explained that a petition must include a written rationale or justification to support the assertion that collecting processing and use information for the chemical substance is of low current interest. In addition, the proposal clarifies that the petition must be accompanied by relevant documents, and include specific citations to information in those documents. The proposed amendments also provide that the petitioner's rationale must include sufficient information upon which the Agency can assess the current need for IUR processing and use information and can make a decision concerning the reporting of that information for the subject chemical. Finally, the proposal clarifies that the burden of proof is on the petitioner to demonstrate why a given chemical substance should be considered of low current interest. The proposed rule has not yet been finalized.

Through this action, EPA is amending the list of chemical substances that are partially exempt from reporting requirements under the IUR regulation. EPA received a petition requesting the addition of the following chemicals to the list of substances in § 710.46(b)(2)(iv) (Ref. 1):

• Aluminum, chlorodiethyl- (CASRN 96-10-6)

• Aluminum, triethyl- (CASRN 97-93-8)

• Aluminum, tris(2-methylpropyl)- (CASRN 100-99-2)

• Aluminum, dichloroethyl- (CASRN 563-43-9)

• Aluminum, trioctyl- (CASRN 1070-00-4)

• Aluminum, tributyl- (CASRN 1116-70-7)

• Aluminum, trihexyl- (CASRN 1116-73-0)

• Aluminum, hydrobis(2-methylpropyl)- (CASRN 1191-15-7)

• Aluminum, di-.mu.-chlorochlorotriethyldi- (CASRN 12075-68-2)

• Aluminum, trichlorotrimethyldi- (CASRN 12542-85-7)

EPA considered the information provided by the petitioner and determined that there is a low current interest in IUR processing and use information because exposure to these substances is not likely to occur due to their high and apparent reactivities, which require the use of preventive measures when handling the substances in order to eliminate the possibility of exposure or release. The reaction of these pyrophoric substances upon contact with air or water is very fast; the nature of the reaction is readily observable (i.e., flames); and the reaction results in a transformation of the aluminum alkyl into another chemical substance once exposed to water or air. Furthermore, use of these substances is very limited as intermediates in chemical synthesis. For all of these reasons, EPA determined that, at this time, collecting IUR processing and use information on these chemicals would not likely further our understanding of potential risks associated with them (Ref. 3).

EPA received 23 non-CBI reports for these 10 chemicals in the 2002 IUR submission period. Since the 23 reports represent only a portion of the total number of reports received, EPA is estimating that 25 reports over 300,000 lbs for these 10 chemicals will be received. Removing the requirement to report processing and use information for 25 reports results in a cost savings of $135,776 to $146,546 in the first reporting cycle and $108,621 to $117,237 in future reporting cycles (Ref. 5).

The Agency acknowledges that additional, unidentified information may exist. If you are in possession of information which is relevant to the Agency's decision to partially exempt the 10 substances listed in Unit II.D., please provide comments following the procedure listed in the ADDRESSES unit.

EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. This final rule will be effective on February 14, 2006 without further notice unless the Agency receives adverse comment by January 17, 2006. If EPA receives adverse comment on this rulemaking, the Agency will publish a timely withdrawal in the Federal Register and will publish a notice of proposed rulemaking in a future issue of the Federal Register . The Agency will address the comments as part of that proposed rulemaking.

The public version of the official record for this rulemaking is contained in two separate dockets that can be accessed as described in the ADDRESSES unit. Docket ID number EPA-HQ-OPPT-2005-0047 contains the main rulemaking record. Additionally, certain supporting records are contained in docket ID number EPA-HQ-OPPT-2004-0048, as identified in the listing contained in this unit. This record includes the documents located in the docket as well as the documents that are referenced in those documents.

1. Letter from Kim Boudreaux, Albemarle Corporation, to OPPT Document Control Officer, EPA, December 24, 2003. Docket document number EPA-HQ-OPPT-2004-0048-0002.

2. Letter from Kim Boudreaux, Albemarle Corporation, to OPPT Document Control Officer, EPA, April 1, 2005. Docket document number EPA-HQ-OPPT-2004-0048-0005.

3. USEPA, “IUR Petition Review Report for aluminum, chlorodiethyl- (CASRN 96-10-6); aluminum, triethyl- (CASRN 97-93-8); aluminum,tris(2-methylpropyl)- (CASRN 100-99-2); aluminum, dichloroethyl- (CASRN 563-43-9); aluminum, trioctyl- (CASRN 1070-00-4); aluminum, tributyl- (CASRN 1116-70-7); aluminum, trihexyl- (CASRN 1116-73-0); aluminum,hydrobis(2-methylpropyl)- (CASRN 1191-15-7); aluminum,di-.mu.-chlorochlorotriethyldi- (CASRN 12075-68-2); aluminum, trichlorotrimethyldi- (CASRN 12542-85-7),” April 25, 2005. Docket document number EPA-HQ-2004-0048-0007.

4. USEPA, “Cost Savings Estimate of Adding 10 Aluminum Alkyls to the 40 CFR 710.46(b)(2) Chemical Substance List,” OPPT, April 28, 2005.

This direct final rule implements minor changes to 40 CFR part 710, resulting in burden and cost reduction. Since this direct final rule does not impose any new requirements, it is not subject to review by the Office of Management and Budget (OMB) under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993).

This direct 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 .

Since this action makes minor changes to 40 CFR part 710, resulting in burden reduction, EPA certifies this action will not have significant economic impact on a substantial number of small entities. There will be no adverse impact on small entities resulting from this action.

This action does not 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).

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 action does not alter the relationships or distribution of power and responsibilities established by Congress.

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.” This direct final 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.

This action does not require OMB review or any other Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).

Because this direct final rule is exempt from review under Executive Order 12866 due to its lack of significance, this direct final rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001).

This 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).

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 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).

Therefore, 40 CFR chapter I is amended as follows:

This listing was proposed in the Federal Register of January 26, 2000 (65 FR 4217). Since that time, with the assistance of the International Association of Fish and Wildlife Agencies (IAFWA), we have conducted extensive discussions with the range States for alligator snapping turtle and map turtles, and have reviewed and considered all public comments received on the proposed rule. Our final decision reflects consideration of the information and opinions we have received.

The alligator snapping turtle ( Macroclemys [= Macrochelys ] temminckii ), the largest freshwater turtle in North America, is a member of the Family Chelydridae, Order Testudinata, Class Reptilia. This North American family includes two monotypic genera. The second genus is Chelydra, represented by the common snapping turtle ( Chelydra serpentina ). The nomenclatural history of the alligator snapping turtle is complex and continues to evolve. The species was first described in 1789 as Testudo planitia, but was placed in the genus Macrochelys by Gray in 1855. Although subsequent authors referred to the genus as Macrochelys, Smith (1955 in Ernst and Barbour 1972) refuted this placement and believed the alligator snapping turtle should be included in the genus Macroclemys. Lovich (1993) supported this approach. In 1995, Webb demonstrated that the genus Macrochelys has precedence over Macroclemys, and the Society for the Study of Amphibians and Reptiles adopted this revision in 2000 (Reed et al. 2002). However, for the purpose of this listing, we have decided to use Macroclemys as the primary genus name because most States and individuals know the species as Macroclemys and continue to use this nomenclature.

The alligator snapping turtle inhabits freshwater river systems and associated fluvial habitats such as lakes, canals, oxbows, swamps, ponds, and bayous throughout the Mississippi River Valley. It also occurs in the rivers and associated habitats of several drainage basins that flow into the Gulf of Mexico, from the Suwanee River, Florida, in the east to the western limits of the species' range in eastern Texas. The current distribution of M. temminckii includes the following States: Alabama, Arkansas, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Oklahoma, Tennessee, and Texas (Ernst and Barbour 1972).

Current research indicates significant range-wide genetic divergence of populations of the species among river drainages. Three genetically distinct subpopulations have been identified: the greater Mississippi River watershed, the Gulf Coastal rivers east of the Mississippi River, and the Suwanee River drainage system (Roman et al. 1999). Extirpation of any local population in one of the three drainage basins may lead to loss of genetic variability and vigor, the increased vulnerability of remaining populations to disease and predation, difficulties in obtaining appropriate founder stock for possible use in future recovery efforts, if needed, and loss of the species' unique function and role in the ecosystem.

Alligator snapping turtles are protected in some form by the majority of States within the species' distribution. However, levels of protection and conservation measures are not consistent from State to State. Regulatory programs for the alligator snapping turtle may include: prohibitions against take from the wild for both commercial and personal purposes; restrictions that ban only commercial harvest from the wild; regulations that prohibit possession, purchase, sale, transport, or export; inclusion on several State lists of endangered and threatened wildlife; and regulated commercial captive production (“farming”).

The alligator snapping turtle is believed to be significantly reduced in abundance throughout a substantial portion of its northern range (Roman et al. 1999). Previously, the species was considered for candidate status under the Endangered Species Act of 1973, as amended (Act). The World Conservation Union (IUCN) classifies the alligator snapping turtle as Vulnerable; according to IUCN criteria, this species will likely become Endangered in the future if the factors leading to its decline continue (IUCN 2000).

The alligator snapping turtle is declining throughout its range as a consequence of several known factors. Two of the leading factors contributing to loss of the species' native habitat are commercial and agricultural development of former bottomland hardwood forest and associated freshwater streams, as well as river and bankside modifications that alter or eliminate crucial nesting sites (Reed et al. 2002). Another major threat is over-collection of live adult turtles from the wild for human consumption and for export of live animals destined for the pet trade (Figure 1). Alligator snapping turtle hatchlings are sold in the domestic and international pet trade, whereas adult specimens are harvested for local human consumption and for use in the specialty meat trade within the United States. Based on the rapid rise in exports of alligator snapping turtles (Figure 1), we believe that a portion of the exports may be for the meat trade. Harvest and trade of mature, breeding adults can rapidly become unsustainable because of the alligator snapping turtle's life history and reproductive strategy. Intense collection over several decades has severely depleted many local populations and/or altered their demographic structure (Roman et al. 1999). Other threats to the alligator snapping turtle include water pollution that often results in the reduction of key prey species and bioaccumulation of industrial and agricultural toxins (Reed et al. 2002).

The alligator snapping turtle cannot sustain significant collection from the wild because of its life history traits (Galbraith et al. 1997). The species does not reach sexual maturity until 11-13 years of age in the wild, and a typical mature female only produces one clutch of eggs per year. A single clutch may comprise 8-52 eggs (Ernst and Barbour 1989). The alligator snapping turtle is characterized by low survivorship in early life stages, and delayed maturation, but surviving individuals may live many decades once they reach maturity. Therefore, the population dynamics of this species are extremely sensitive to the harvest of adult females. An adult female harvest rate of less than 2 percent per year is considered unsustainable, and harvest of this magnitude or greater will result in significant local population declines (Reed et al. 2002).

As noted above, harvest controls for the species vary by State agencies. Commercial harvest and trade are prohibited in most range States, although individual turtles may be taken from the wild for personal use in many States. The State of Louisiana now prohibits commercial harvest of alligator snapping turtles and limits recreational take to one turtle per day per licensed fisher under recent changes in state harvest regulations (Louisiana Department of Wildlife and Fisheries 2004). In addition, Louisiana closely regulates all captive breeding of alligator snapping turtles for domestic and international trade. The State of Mississippi permits trade in farm-reared alligator snapping turtles. Hatchling alligator snapping turtles offered for sale in the pet trade are often advertised as “captive-bred.” During the comment period, the State of Louisiana confirmed that many of the animals in trade are indeed captive-bred in the State. Louisiana turtle farms operate under strict statutes that require sanitary conditions, including testing for Salmonella prior to export (James H. Jenkins, Jr., Secretary, Louisiana Department of Wildlife and Fisheries, in litt. to the Service 2000).

We formerly believed that many exported hatchlings were derived from wild-collected eggs; however, recent information indicates that this practice is not as common as previously supposed (James H. Jenkins, Jr., Secretary, Louisiana Department of Wildlife and Fisheries, in litt. to the Service 2000). Prices for alligator snapping turtles vary greatly based on size, market demand, age, coloration, origin (wild-caught versus captive-bred), and condition. TRAFFIC-North America, the wildlife trade monitoring network, notes that most live adult alligator snapping turtles are exported to Japan and Hong Kong (Simon Habel, Director, TRAFFIC-North America, in litt. to the Service 2000).

Data collected by the Service's Office of Law Enforcement (OLE) indicate that the volume of trade in alligator snapping turtles has increased substantially in the past decade, from 290 specimens in 1989 to 23,780 specimens in 2000 (Figure 1). These data were obtained from OLE's database containing Declaration Forms 3-177, a declaration that must be filed by individuals and commercial businesses upon international importation or exportation of wildlife, including parts and products. We believe these data are minimum figures, because not all shipments that were exported were declared or recorded to the species level, particularly in the earlier years of the decade, and the data do not include illegal trade.

The declared origin of exported alligator snapping turtles began to shift during the late 1990s (Figure 2). In 1996, the majority of alligator snapping turtles presented for export were declared as having been harvested from the wild. As the turtle-farming industry has increased, so too have exports of farm-raised turtles, although dependence on wild-caught turtles has not

Regulations implemented under the authority of the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq. ) and the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) governing the harvest of BFT by persons and vessels subject to U.S. jurisdiction are found at 50 CFR part 635. The 2005 BFT fishing year began on June 1, 2005, and ends May 31, 2006. The final initial 2005 BFT specifications and General category effort controls (June 7, 2005; 70 FR 33033) established the following RFD schedule for the 2005 fishing year: All Fridays, Saturdays, and Sundays from November 18, 2005, through January 31, 2006, and Thursday, November 24, 2005, inclusive, provided quota remained available and the fishery was open. RFDs are intended to extend the General category BFT fishery late into the season and provide for a winter fishery in the southern Atlantic region.

Under 50 CFR 635.23(a)(4), NMFS may increase or decrease the General category daily retention limit of large medium and giant BFT over a range from zero (on RFDs) to a maximum of three per vessel to allow for maximum utilization of the quota for BFT. NMFS has taken multiple actions during the 2005 fishing year in an attempt to allow for maximum utilization of the General category BFT quota. On September 28, 2005 (70 FR 56595), NMFS adjusted the commercial daily BFT retention limit (on non-RFDs), in all areas, for those vessels fishing under the General category quota, to two large medium or giant BFT, measuring 73 inches (185 cm) or greater curved fork length (CFL), per vessel per day/trip, effective through January 31, 2006, inclusive, provided quota remained available and the fishery remained open. On November 9, 2005 (70 FR 67929), NMFS waived the previously designated RFDs for the month of November and adjusted the daily retention limit on those RFDs to two large medium or giant BFT.

On December 7, 2005 (70 FR 72724), NMFS adjusted the General category quota by conducting a 200 mt inseason quota transfer to the Reserve category, resulting in an adjusted General category quota of 708.3 mt. This action was taken to account for any potential overharvests that may occur in the Angling category during the 2005 fishing year (June 1, 2005 through May 31, 2006) and to ensure that U.S. BFT harvest is consistent with international and domestic mandates.

Based on a review of dealer reports, daily landing trends, available quota, weather conditions, and the availability of BFT on the fishing grounds, NMFS has determined that waiving three RFDs established for the month of December and increasing the General category daily BFT retention limit on those RFDs is warranted. Therefore, NMFS adjusts the General category daily BFT retention limits for December 16, 17, and 18, 2005, to two large medium or giant BFT per vessel. NMFS has selected these days to give enough advance notice to fishery participants and to assist the fishery access the available quota.

NMFS recognizes that catch rates have continued to be low so far this season however, they may increase rapidly, and to ensure equitable fishing opportunities in all areas and provide opportunities for a late winter General category BFT fishery, NMFS needs to carefully monitor and manage this fishery. Conversely, if catch rates continue to be low, some or all of the remaining previously scheduled RFDs may be waived as well.

The intent of this current adjustment is to provide reasonable opportunity to utilize landings quota of BFT while maintaining an equitable distribution of fishing opportunities to help achieve optimum yield in the General category BFT fishery, to collect a broad range of data for stock monitoring purposes, and to be consistent with the objectives of the HMS FMP.

NMFS selected the RFDs being waived after examining current fishing year catch and effort rates, previous fishing years catch and effort rates, predicted weather patterns over the next week, and the available quota for the 2005 fishing year. NMFS will continue to monitor the BFT fishery closely through dealer landing reports. Depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional retention limit adjustments are necessary to ensure available quota is not exceeded or, to enhance scientific data collection from, and fishing opportunities in, all geographic areas.

Closures or subsequent adjustments to the daily retention limits, if any, will be published in the Federal Register . In addition, fishermen may call the Atlantic Tunas Information Line at (888) 872-8862 or (978) 281-9260, or access the Internet at www.nmfspermits.com for updates on quota monitoring and retention limit adjustments.

The Assistant Administrator for Fisheries, NOAA (AA), finds that it is impracticable and contrary to the public interest to provide prior notice of, and an opportunity for, public comment on this action.

NMFS has recently become aware of increased availability of large medium and giant BFT on the fishing grounds. This increase in abundance provides the potential for the fishery to increase General category landings rates if participants are authorized to harvest two large medium or giant BFT per day on previously designated RFDs. The regulations implementing the 1999 Fishery Management Plan (FMP) for Atlantic Tunas, Swordfish, and Sharks provide for inseason retention limit adjustments to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Based on a review of recent information regarding the availability of BFT on the fishing grounds, dealer reports, daily landing trends, available quota, and weather conditions, NMFS has determined that this retention limit adjustment is warranted to increase access to available quota.

Delays in waiving the selected December RFDs, and thereby increasing the General category daily retention limit, would be contrary to the public interest. Such delays would adversely affect those General category vessels that would otherwise have an opportunity to harvest BFT on an RFD and would further exacerbate the problem of low catch rates. Limited opportunities to access the General category quota may have negative social and economic impacts to U.S. fishermen that depend on catching the available quota. For the General category, waiving of the selected December RFDs needs to be done as expeditiously as possible for the General category participants to be able to use the waived RFDs to take advantage of the adjusted retention limits and plan accordingly.

Therefore

This action is being taken under 50 CFR 635.23(a)(4) and is exempt from review under Executive Order 12866.