You may examine the 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 supplemental notice of proposed rulemaking (SNPRM) 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 SNPRM was published in the Federal Register on November 9, 2005 (70 FR 67939). That SNPRM proposed to require verifying the part and serial numbers of certain main landing gear (MLG) bogie beam pivot pins; replacing those pivot pins with new or overhauled pivot pins if necessary; and ultimately replacing all pivot pins with new, improved pivot pins. That SNPRM also proposed to require repetitive lubrications and inspections of the pivot pin, and related investigative and corrective actions if necessary.

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

The Boeing Company requests that the word “inspection” in the last sentence of paragraph (h) of the SNPRM be removed. Boeing notes that there are no inspection requirements in paragraph (h).

We agree. Paragraph (h) contains special lubrication requirements and no inspection requirements. Therefore, we have changed the final rule to clarify that doing the actions in paragraph (j) of the AD terminates the special lubrication requirements of paragraph (h), rather than the inspection requirements.

The Air Transport Association (ATA), on behalf of American Airlines, does not object to the proposed lubrication and terminating modification, but does not believe any of the three proposed inspection options are viable. ATA and American recommend that the FAA and the manufacturer develop a practical and effective interim action because the daily pin measurements are impractical to perform. ATA and American state that these measurements require accurate and unique tools, and they are also physically awkward. In addition, ATA and American believe that the second proposed option (the ultrasonic inspections) require unique tools and may provide faulty readings due to the stamped part number on the pin. ATA and American believe that these two options for inspections may lead to unnecessary flight cancellation. ATA and American also state that the third option (the detailed inspection) requires pin removal, and there is no value added in removing and reinstalling the old pin. American believes that airlines would prefer to replace the pins at the time of inspection, which may cause an industry shortage of pins.

We partially agree. We agree that ATA and American Airlines have valid concerns, and we recognize that the proposed inspections may not be suitable for each operator. For that reason we carefully considered a variety of inspection methods with varying levels of reliability and corresponding repeat intervals in order to ease the burden on operators. In fact, the manufacturer developed its service information with the participation of the ATA lead airline. Note that no single method is required in order to comply with the AD. By providing alternatives, we consider that a viable inspection method is available to operators. We disagree with re-developing interim actions because a variety of inspection methods have already been provided. If American Airlines wishes to use a new alternative inspection that provides an acceptable level of safety, American Airlines may request an approval of an alternative method of compliance in accordance with the procedures in paragraph letter (l) of this AD. In regard to the availability of pins, the manufacturer has assured us that sufficient new-material pins will be supplied within the replacement schedule of this AD, so an industry shortage of pins should not occur. Given that we have received 11 reports of failed pins since the issuance of the service information that is cited in this AD, interim inspections are necessary until these pins can be replaced. We have not changed the AD in this regard.

Japan Airlines notes that the terminating action provided in paragraph (j) of the NPRM is written on the airplane level rather than the component level. Japan Airlines requests that we include as a terminating action in the AD the installation of an overhauled MLG assembly with a new part number (P/N) 161T1145-5 pivot pin in accordance with Boeing 767 Component Maintenance Manual (CMM) 32-11-30, new bogie beam bushings in accordance with Boeing 767 CMM 32-11-50, and inner cylinder pivot bushings in accordance with Boeing 767 CMM 32-11-40. Japan Airlines believes that installing an overhauled MLG assembly with the new part number is the same action as Part 5 of Boeing Alert Service Bulletin 767-32A0199, Revision 2, dated May 26, 2005.

We partially agree. We infer that Japan Airlines wants to track AD compliance by tracking MLG modification status rather than tracking airplane status. We agree that installing an overhauled MLG assembly with a new part number (P/N) 161T1145-5 pivot pin, is the same as the terminating action provided in paragraph (j) of the NPRM; this action would bring the airplane into compliance. However, by regulation AD compliance is tracked at the airplane level rather than at the component level. For this reason we do not agree with the commenter's request. We have not changed the AD in this regard.

The Boeing Company states that the estimated costs in the SNPRM are incomplete and inaccurate. Boeing states that the costs do not reflect those in the manufacturer's service information. In addition, Boeing points out that the costs are a per-pin cost rather than a per-airplane cost.

We partially agree. The cost impact figures discussed in AD rulemaking actions represent only the time necessary to perform the specific actions actually required by the AD. These figures typically do not include incidental costs, such as the time required to gain access and close up, planning time, or time necessitated by other administrative actions. In this case, the costs include only the time to do the inspections, lubrications, and replacement. However, we have revised the last two rows of the Estimated Costs table to multiply by two the costs that were listed in the NPRM as “per pivot pin” to more accurately reflect the costs per airplane.

We have removed Note 2 of the NPRM, which gave a definition of a “detailed inspection.” Boeing Alert Service Bulletin 767-32A0199, Revision 2, now includes this definition.

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 857 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 Bombardier Model DHC-8-400 series airplanes. That NPRM was published in the Federal Register on February 8, 2006 (71 FR 6411). That NPRM proposed to require replacing all domed anchor nuts at all attachment locations of the upper fuel access panels of the center wing in the wet bay location with new nuts.

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 the telephone number in the FOR FURTHER INFORMATION CONTACT paragraph.

We have carefully reviewed the available data, and determined that air safety and the public interest require adopting the AD as proposed.

This AD will affect about 20 airplanes of U.S. registry. The required actions will take about 62 work hours per airplane, at an average labor rate of $65 per work hour. Required parts will cost about $300 per airplane. Based on these figures, the estimated cost of the AD for U.S. operators is $86,600, or $4,330 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 transport category airplanes. That NPRM was published in the Federal Register on January 25, 2006 (71 FR 4069). That NPRM proposed to require determining if the terminal fittings of the spars of the wings are made of 7079 aluminum alloy material. For any positive finding, the NPRM proposed to require doing repetitive inspections for cracks and corrosion of all exposed surfaces of the terminal fitting bores; doing repetitive inspections for cracks, corrosion, and other surface defects, of all exposed surfaces, including the flanges, of the terminal fitting; applying corrosion inhibiting compound to the terminal fittings; and repairing or replacing any cracked, corroded, or defective part with a new part. The NPRM also proposed to provide an optional terminating action for the repetitive inspections.

We provided the public the opportunity to participate in the development of this AD. We have considered the comment received. The commenter, Boeing, supports the NPRM.

We have carefully reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD as proposed.

This AD is considered to be interim action. The inspection reports that are required by this AD will enable the manufacturer to obtain better insight into the extent of the cracking and corrosion of the terminal fittings of the front and rear spars of the wings in the fleet, and to develop additional action if necessary to address the unsafe condition. If additional action is identified, we may consider further rulemaking.

There are about 302 airplanes of the affected design in the worldwide fleet. This AD will affect about 157 airplanes of U.S. registry. The determination of forging number/material identification will 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 AD for U.S. operators is $40,820, or $260 per airplane.

Accomplishing the fluorescent dye penetrant and detailed inspections, if required, will take about 16 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, we estimate the cost of the inspections to be $1,040 per airplane, per inspection cycle.

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 Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-120, -120ER, -120FC, -120QC, and -120RT airplanes. That NPRM was published in the Federal Register on January 25, 2006 (71 FR 4075). That NPRM proposed to require a one-time inspection of the interior of the internal elevator torque tube of each elevator control surface for oxidation and corrosion, and corrective actions.

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 carefully reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed.

This AD will affect about 108 airplanes of U.S. registry. The required actions will take about 3 work hours per airplane, at an average labor rate of $65 per work hour. Based on these figures, the estimated cost of this AD for U.S. operators is $21,060, or $195 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 Aerospatiale Model ATR42 airplanes and Model ATR72 airplanes. That NPRM was published in the Federal Register on January 19, 2006 (71 FR 3023). That NPRM proposed to require installing protective ramps on trim panel 110VU; and inspecting the protective guard of the standby pitch trim switch to determine if it is missing, damaged, or ineffective, and doing the corrective action 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 corrected the applicability in paragraph (c) of the AD to reidentify the modification as “ATR Modification 05450.”

We have revised the applicability in paragraph (f) of the AD to identify model designations as published in the most recent type certificate data sheet for the affected models.

We have carefully reviewed the available data 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.

This AD affects about 69 airplanes of U.S. registry. The required actions will take about 1 work hour per airplane, at an average labor rate of $65 per work hour. Required parts will cost about $465 per airplane. Based on these figures, the estimated cost of the AD for U.S. operators is $36,570, or $530 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.

Veterinary Specialties, Inc., 387 North Valley Ct., Barrington, IL 60010, has informed FDA that it has transferred ownership of, and all rights and interest in, NADA 65-107 for ENTROMYCIN (bacitracin methylene disalicylate and streptomycin sulfate) Powder to Alpharma Inc., One Executive Dr., Fort Lee, NJ 07024. Accordingly, the regulations are amended in 21 CFR 520.154b to reflect this change of sponsorship and a current format.

Following these changes of sponsorship, Veterinary Specialties, Inc., is no longer the sponsor of an approved application. Accordingly, 21 CFR 510.600(c) is being amended to remove the entries for Veterinary Specialties, Inc.

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.

(a) Specifications. Each gram of powder contains 200 units bacitracin methylene disalicylate and streptomycin sulfate equivalent to 20 milligrams of streptomycin.

(b) Sponsor. See No. 046573 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Administer 1 level teaspoonful per 10 pounds of body weight three times daily, mixed in a small quantity of liquid or feed.

(2) Indications for use. For the treatment of bacterial enteritis caused by pathogens susceptible to bacitracin and streptomycin such as Escherichia coli, Proteus spp., Staphylococcus spp., and Streptococcus spp., and for the symptomatic treatment of associated diarrhea.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Pennfield Oil Co., 14040 Industrial Rd., Omaha, NE 68144, filed a supplement to NADA 138-935 for PENNCHLOR (chlortetracycline) Type A medicated articles used for making medicated feeds for the treatment of various bacterial diseases of livestock. The supplemental NADA provides for a 0-day withdrawal time before slaughter when Type C medicated feeds containing chlortetracycline are fed to cattle. The application is approved as of February 28, 2006, and the regulations are amended in 21 CFR 558.128 to reflect the approval. The basis of approval is discussed in the freedom of information summary.

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

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

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

We did not publish a notice of proposed rulemaking (NPRM) for this regulation. Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing an NPRM. Logistical details surrounding the event were not finalized and presented to the Coast Guard in time to draft and publish an NPRM. As such, the event would occur before the rulemaking process was complete. Because of the dangers posed by the pyrotechnics used in this fireworks display, special local regulations are necessary to provide for the safety of event participants, spectator craft, and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event.

For the same reasons listed in the previous paragraph, 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 the effective date of this rule would expose mariners to the dangers posed by the pyrotechnics used in this fireworks display.

The San Francisco Giants are sponsoring a brief fireworks display on April 7, 2006 in the waters of San Francisco Bay near AT&T Park. The fireworks display is meant for entertainment purposes as a finale to conclude the 2006 San Francisco Giants' Opening Night baseball game. These special local regulations are being issued to establish a temporary regulated area in San Francisco Bay around the fireworks launch barge during loading of the pyrotechnics, during the transit of the barge to the display location, and during the fireworks display. This regulated area around the launch barge is necessary to protect spectators, vessels, and other property from the hazards associated with the pyrotechnics on the fireworks barge. The Coast Guard has granted the event sponsor a marine event permit for the fireworks display.

The Coast Guard is establishing temporary special local regulations on specified waters off of the San Francisco waterfront. During the loading of the fireworks barge, while the barge is being towed to the display location, and until the start of the fireworks display, the special local regulations apply to the navigable waters around and under the fireworks barge within a radius of 100 feet. During the 15-minute fireworks display, the area to which these special local regulations apply will increase in size to encompass the navigable waters around and under the fireworks barge within a radius of 1,000 feet. Loading of the pyrotechnics onto the fireworks barge is scheduled to commence at 1 p.m. on April 7, 2006, and will take place at Pier 50 in San Francisco. Towing of the barge from Pier 50 to the display location is scheduled to take place between 5:30 p.m. and 7:30 p.m. on April 7, 2006. During the fireworks display, scheduled to commence at approximately 9:30 p.m., the fireworks barge will be located approximately 1,000 feet off of Pier 48 in position 37°46′57.2″ N., 122°23′58.0″ W.

The effect of the temporary special local regulations will be to restrict general navigation in the vicinity of the fireworks barge while the fireworks are loaded at Pier 50, during the transit of the fireworks barge, and until the conclusion of the scheduled display. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area. These regulations are needed to keep spectators and vessels a safe distance away from the fireworks barge to ensure the safety of participants, spectators, and transiting vessels.

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.

Although this regulation prevents traffic from transiting a portion of San Francisco Bay during the event, the effect of this regulation will not be significant due to the small size and limited duration of the regulated area. The entities most likely to be affected are pleasure craft engaged in recreational activities and sightseeing. We expect the economic impact of this rule to be so minimal that a full Regulatory Evaluation is unnecessary.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule is not expected to have a significant economic impact on a substantial number of entities, some of which may be small entities. This rule may affect owners and operators of pleasure craft engaged in recreational activities and sightseeing. This rule will not have a significant economic impact on a substantial number of small entities for several reasons: (i) Vessel traffic can pass safely around the area, (ii) vessels engaged in recreational activities and sightseeing have ample space outside of the affected portion of San Francisco Bay to engage in these activities, (iii) this rule will encompass only a small portion of the waterway for a limited period of time, and (iv) the maritime public will be advised in advance of these special local regulations via public notice to mariners.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we offered to assist small entities in understanding the rule so that they could better evaluate its effects on them and participate in the rulemaking process. If the rule will affect your small business, organization, or government jurisdiction and you have questions concerning its provisions, options for compliance, or assistance in understanding this rule, please contact Lieutenant Junior Grade Jennifer Green, U.S. Coast Guard Sector San Francisco, at (510) 437-5873.

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

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

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

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

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

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

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

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

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

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.

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

A final “Environmental Analysis Check List” and a final “Categorical Exclusion Determination” will be available in the docket where indicated under ADDRESSES.

I. Table of Contents II. Summary of Action III. Authority IV. Public Participation A. Amendments to the I/M Performance Standards B. Amendments to Program Evaluation Requirements C. Amendments to Update SIP Submission Deadlines V. Discussion of Major Issues A. Impact on Existing I/M Programs B. Impact on Future I/M Programs VI. Economic Costs and Benefits VII. Statutory and Executive Order Review A. Executive Order 12866: Regulatory Planning and Review B. Reporting and Recordkeeping Requirement C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act E. Executive Order 13132: Federalism F. Executive Order 13084: Consultation and Coordination With Indian Tribal Governments G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution or Use I. National Technology Transfer and Advancement Act J. Congressional Review Act K. Petitions for Judicial Review II. Summary of Action

When the I/M rule was first published in November 1992, some of the deadlines were expressed relatively (e.g., “within X years of Y * * *”) while others were set as explicit dates (e.g., “no later than November 15, 1993 * * *”). Several of those explicit deadlines have since passed or otherwise been rendered irrelevant due to actions such as the revocation of the 1-hour ozone standard (the majority of deadlines contained in the original 1992 I/M rule were linked to the 1-hour standard and its associated milestones for attainment and interim progress). Today's action finalizes the revisions to the I/M rule that were proposed January 6, 2005 (70 FR 1314). These revisions are aimed at such timing-related references as submission dates, start dates, evaluation dates, and other milestones and/or deadlines and are being made to make the I/M rule relevant for those areas that will be newly required to begin I/M programs as a result of being designated and classified under the 8-hour ozone standard.

This action does not revise or establish new requirements for existing I/M programs that were established in response to the 1-hour ozone standard. In general, if an existing I/M area was not able to redesignate to attainment for the 1-hour ozone standard prior to revocation of that standard (and is also designated as non-attainment for the 8-hour standard, regardless of classification or subpart) then that area is required to continue implementing an I/M program until it has attained the 8-hour ozone standard under EPA's anti-backsliding regulations promulgated to facilitate transition from planning for the 1-hour to the 8-hour ozone standard. Readers interested in learning more about how the Clean Air Act's (Act or CAA) anti-backsliding provisions apply to I/M under the 8-hour standard should consult 40 CFR 51.905 (“Transition from the 1-hour NAAQS to the 8-hour NAAQS and anti-backsliding”) as well as the May 12, 2004 memorandum concerning exceptions to the general anti-backsliding policy for certain maintenance areas signed by Tom Helms and Leila Cook entitled “1-Hour Ozone Maintenance Plans Containing Basic I/M Programs,” a copy of which is contained in the docket for this rulemaking.

Upon becoming effective, today's action will: (1) Revise §§ 51.351 and 51.352 (the basic and enhanced I/M performance standards) to update the start date and model year coverage associated with specific elements of the basic and enhanced I/M performance standards as well as to set the benchmark comparison date(s) for performance standard modeling purposes that better reflects milestones associated with the 8-hour ozone standard; (2) revise § 51.353 (network type and program evaluation) to make the deadline for beginning the first round of program evaluation testing (which is currently listed as “no later than November 30, 1998”) a relative deadline keyed to the date of program start up; (3) amend § 51.360 (waivers and compliance via diagnostic inspection) so that the deadline for establishing full waiver limits for those basic I/M programs choosing to allow waivers (currently, “no later than January 1, 1998”) becomes “January 1, 1998, or coincident with program start up, whichever is later”; (4) update § 51.372 (state implementation plan submissions) to set the I/M SIP submission deadline for areas newly required to adopt I/M programs under the 8-hour ozone standard as 1 year after the effective date of today's action or 1 year after the effective date of designation and classification under the 8-hour standard (whichever is later); (5) update § 51.373 (implementation deadlines) to establish the implementation deadline for new I/M programs required under the 8-hour standard as 4 years after the effective date of designation and classification under the 8-hour ozone standard; and (6) revise § 51.373 (implementation deadlines) to clarify that the deadline for beginning OBD testing for areas newly required to implement I/M as a result of being designated and classified under the 8-hour ozone standard is “coincident with program start up.”

Authority for the rule changes being made as a result of today's action is granted to EPA by sections 182, 184, 187, and 118 of the Clean Air Act as amended (42 U.S.C. 7401, et seq.).

Written comments on the January 6, 2005 Notice of Proposed Rulemaking (NPRM) were received from three sources prior to the close of the public comment period on February 7, 2005. The commenters included two state environmental agencies and one I/M testing contractor. Several of the comments received fell well outside the scope of the January 6, 2005 proposal and often requested additional flexibility for existing I/M programs which EPA does not have the legal authority to grant under the Clean Air Act as it is currently written. These comments, while noted, will not be addressed in today's action. No comments were received on the proposed amendments to the basic I/M waiver requirements or implementation deadlines, and these amendments will therefore be finalized as proposed. (For more information on these amendments, please see the January 6, 2005 proposal, section IV(C), “Amendments to the Basic I/M Waiver Requirements,” and section IV(E), “Amendments to Update Implementation Deadlines.”) The remaining comments are summarized and responded to below, under the proposed revision(s) to which they apply.

EPA proposed to revise the basic I/M performance standard for areas newly required to implement a basic I/M program as a result of being designated and classified under the 8-hour ozone NAAQS as follows: (1) Start date: Four years after the effective date of designation and classification under the 8-hour ozone standard; 1 (2) emission test types: Model Year (MY) 1968-2000—idle, MY 2001 and newer—onboard diagnostic (OBD) check; (3) evaluation date: six years after the effective date of designation and classification under the 8-hour ozone standard rounded to the nearest July. All other basic I/M performance design elements remain the same as previously promulgated for 1-hour ozone non-attainment areas (see 40 CFR 51.352). For areas newly required to implement an enhanced I/M program as a result of being designated and classified under the 8-hour ozone NAAQS, EPA proposed establishing an 8-hour ozone enhanced I/M performance standard which assumes the same program design elements as the current low enhanced I/M performance standard defined at 40 CFR 51.351(g) but with the following exceptions: (1) Start date: four years after the effective date of designation and classification under the 8-hour ozone standard; (2) emission test types: MY 1968-2000—idle, MY 2001 and newer—onboard diagnostic (OBD) check; (3) evaluation dates: six years after the effective date of designation and classification under the 8-hour ozone standard rounded to the nearest July and the applicable attainment date (as defined under 40 CFR 51.903), also rounded to the nearest July.

Per the proposal, a state's program would be considered in compliance with the relevant 8-hour ozone I/M performance standard if it can demonstrate through modeling that the proposed program will achieve the same (or better) percent reduction in HC (and, for enhanced programs, NOX) as achieved by the performance standard model program based upon an evaluation date set to the six year anniversary of the effective date of the area's designation and classification under the 8-hour ozone standard, rounded to the nearest July. Areas required to implement enhanced I/M as a result of being designated and classified under the 8-hour ozone standard also must demonstrate through modeling that the same (or better) percent reduction as achieved under the six-year anniversary milestone above is still being achieved as of the first July following the area's applicable attainment date under the 8-hour ozone standard. The intent of these proposed amendments was to tie the performance standard deadlines to the date of an area's designation and classification under the 8-hour ozone standard and to provide areas newly required to implement I/M under that standard a level of flexibility comparable to that currently available to areas required to do I/M under the 1-hour ozone standard.

Both state commenters supported those elements of the proposal aimed at providing I/M areas flexibility to adopt I/M programs that rely primarily or wholly upon OBD-only testing of the OBD-equipped in-use fleet. One I/M contractor objected to the proposed revisions to the I/M rule's performance standard requirements. In their comments, the contractor claimed that EPA's proposed revisions would essentially eliminate the difference between basic and enhanced I/M. According to this commenter, as a result of EPA's proposal, the primary difference between the basic and enhanced performance standards would be that the basic performance standard would actually be more rigorous with regard to compliance and waiver rates—a difference which seemingly contradicts the clear meaning of the words “basic” and “enhanced,” and runs contrary to Congressional intent. According to this commenter, the enhanced performance standard (as proposed) would include only two enhancements relative to the basic performance standard: (1) The inclusion of on-road testing, as required by the CAA, and (2) the inclusion of visual inspections that are largely redundant for OBD-equipped vehicles. According to this commenter, the CAA requires all I/M programs (and, by implication, all I/M performance standards) to include OBD testing of OBD-equipped vehicles from MY 1996 and newer. Therefore, EPA's proposal to limit OBD testing coverage in the basic and enhanced performance standards to MY 2001 and newer vehicles is in direct contradiction of the clear language of the Act. The commenter concluded that EPA's proposed changes would artificially and unreasonably lower existing I/M performance standards.

EPA does not agree with the characterization that it's proposal essentially eliminates the difference between basic and enhanced I/M. Omitted from the differences cited in the comments provided is perhaps the most significant statutory difference between basic and enhanced I/M: The fact that enhanced I/M programs are required to include the testing of light-duty trucks while basic I/M programs are not. This is an important difference, especially in light of the significant growth in the light-duty truck and Sport Utility Vehicle (SUV) markets since passage of the Clean Air Act Amendments of 1990. It is because of this difference that the proposed enhanced I/M performance standard for 8-hour ozone non-attainment areas is and will continue to be significantly more stringent than the proposed basic I/M performance standard, even as the inclusion of OBD testing narrows the previous gap between I/M tailpipe test types.

EPA also does not agree with the claim that the CAA requires all I/M programs (and, by implication, all I/M performance standards) to include OBD testing of MY 1996 and newer, OBD-equipped vehicles. While the CAA does require all I/M programs to include OBD testing and the repair of vehicles that fail the OBD test, it does not specify model year coverage, nor does it suggest that I/M programs test all such vehicles without exception. Further, the statute does not explicitly require the inclusion of OBD testing as part of the performance standards. In fact, to require such comprehensive testing coverage in the performance standards would effectively bar states from exempting the newest such vehicles from testing, even though the statistical likelihood that such vehicles will fail the test and require repair is exceedingly small. Such a requirement would also all but eliminate the states' ability to otherwise tailor I/M programs to meet local needs. Lastly, suggesting that the CAA requires EPA to adopt the most rigorous performance standards possible ignores the Act's mandate that states be allowed flexibility in designing their I/M programs and also contradicts a DC Circuit Court's ruling in which the court found “* * * it clear that the statute does not mandate that the EPA set the most stringent possible annual performance standard. With its repeated emphasis on state flexibility, echoed in the legislative history, see S. Rep. No. 101-228, 101st Cong., 2d Sess. 39, reprinted in 1990 U.S.C.C.A.N. 3425, the statute appears to place a premium on state ability to shuffle aspects of the program to meet the EPA's requirements and individual state needs * * *. Implicitly, at least, Congress thus appears to have contemplated considerable EPA discretion in standard-setting” (Natural Resource Defense Council, Inc. v. EPA, 92-1535—DC Cir. 1994).

Given EPA's conclusion that the only objections raised with regard to this portion of EPA's proposal were inaccurate in both their substance and conclusions, today's action finalizes the January 6, 2005 I/M performance standard revisions as proposed.

Section 182(c)(3)(C) of the 1990 CAA requires that each state subject to enhanced I/M shall “biennially prepare a report to the Administrator which assesses the emission reductions achieved by the program required under this paragraph based upon data collected during the inspection and repair of vehicles. The methods used to assess the emission reductions shall be those established by the Administrator.” Section 51.353 of EPA's current I/M rule (network type and program evaluation) provides additional detail on how this requirement is to be met, including minimum sampling requirements and specific deadlines by which program evaluation testing must begin. Currently, § 51.353(c)(4) of the I/M rule specifies that the first round of program evaluation testing is to begin “no later than November 30, 1998,” which EPA proposed to change to “no later than 1 year after program start-up.”

Although EPA did not receive comment on the specific amendment proposed for this section of the I/M rule, one commenter did comment on program evaluation in general, requesting that EPA provide “* * * [c]larification of program evaluation and program evaluation sampling requirements, particularly as applied to programs utilizing test procedures specified in applicable performance standards (i.e. IM240 and/or OBD). Illinois is currently collecting mass emissions data (full-term IM240) on 0.1% of 1981 and newer vehicles, including 1996 and newer vehicles subject to OBD. This evaluation testing (particularly on OBD-equipped vehicles) has proven to be somewhat controversial and unpopular with vehicle owners.”

Given that the comment in question does not address the proposal under consideration, today's action will finalize the amendment as proposed. Concerning the request for additional guidance and clarification with regard to the program evaluation requirements in general—and with regard to OBD-equipped vehicles in particular—EPA will take this request into consideration in its development of future I/M guidance.

EPA proposed to update § 51.372 (State Implementation Plan submissions) to clarify that areas newly required to implement I/M as a result of being designated and classified under the 8-hour ozone standard are required to submit their I/M SIPs, whether basic or enhanced, within 1 year after the effective date of today's action, i.e., May 8, 2007. For areas newly designated as non-attainment under the 8-hour ozone standard after the effective date of today's action, EPA proposed that those areas submit their I/M SIPs within 1 year of the effective date of their designation and classification.

One state commenter objected to the proposed SIP submission deadlines, maintaining that EPA's publication schedule and the State's own administrative procedures requirements will make it all but impossible to promulgate the necessary regulations before the summer of 2007.

Based upon its experience with the submission of I/M SIPs in response to the 1990 Act's requirements for 1-hour I/M programs, EPA considers the proposed 1 year timeframe a reasonable amount of time in which to develop and submit an I/M SIP, given the states' need to secure legal authority, develop implementing regulations, provide notice-and-comment opportunity, etc. As noted by EPA both in it's general preamble published after the 1990 amendments to the Act and in the 1992 I/M rules (57 FR 13498, 13517 and 57 FR 52950, 52970, respectively) EPA has long believed that one year is an appropriate time period for states to obtain necessary legislative authority to adopt and submit an I/M program. EPA will therefore finalize this section of the January 6, 2005 notice as proposed.

Today's action does not change the requirements that currently apply to existing I/M programs adopted as a result of an area being classified under the 1-hour ozone standard. Readers interested in learning the conditions under which an existing 1-hour I/M program must continue operation under the 8-hour standard should consult 40 CFR 51.905 (“Transition from the 1-hour NAAQS to the 8-hour NAAQS and anti-backsliding”).2

Today's action is intended specifically for those areas which currently do not perform I/M testing, but will be required to do so as a result of being designated and classified under the 8-hour ozone standard. Upon becoming effective, these amendments will allow future I/M program areas the flexibility necessary to design from the ground up reasonable, cost effective, motorist-friendly I/M programs that take full advantage of advances in vehicle and vehicle-testing technology, as well as fleet turnover.

Today's action provides areas new to I/M under the 8-hour ozone standard the ability to adopt more cost effective and efficient programs than would otherwise be the case. This action will therefore lessen rather than increase the potential economic burden on states of implementing such programs. Furthermore, this rule does not affect existing state programs meeting the previously applicable requirements.

Under Executive Order 12866, (58 FR 51735; October 4, 1993) the Agency must determine whether the regulatory action is “significant” and therefore subject to OMB review and the requirements of the Executive Order. The Order defines significant “regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more, or otherwise adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof;

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, it has been determined that this final rule is a “significant regulatory action” within the meaning of the Executive Order. EPA has submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

This action does not impose any new information collection burden because it does not change the pre-existing information collection requirements for I/M programs. The Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations (40 CFR part 51, subpart S) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2060-0252, EPA ICR number 1613.02. A copy of the OMB approved Information Collection Request (ICR) may be obtained from Susan Auby, Collection Strategies Division; U.S. Environmental Protection Agency (2822T); 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by calling (202) 566-1672.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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

The Regulatory Flexibility Act generally requires an Agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedures Act or any other statute unless the Agency certifies the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business that is a small industrial entity as defined in the U.S. Small Business Administration (SBA) size standards. (See 13 CFR 121.); (2) a governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This rule will not impose any requirements on small entities. This action will impact States, not small entities. Furthermore, the action will lessen rather than increase the potential economic burden on the States of implementing such programs. In addition, States are under no obligation, legal or otherwise, to modify existing plans meeting the previously applicable requirements as a result of today's action.

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

EPA has determined that this action itself does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments, in the aggregate, or the private sector in any one year. The primary purpose of this action is to amend the existing Federal I/M regulations to provide flexibility in how the regulations cover areas newly designated non-attainment under the 8-hour ozone ambient air quality standards. Clean Air Act sections 182(b)(4) and 182(c)(3) require the applicability of I/M to such areas. Thus, although this action explains how I/M should be conducted, it merely implements already established law that imposes I/M requirements and does not itself impose requirements that may result in expenditures of $100 million or more in any year. The intention of this action is to improve the I/M regulation by implementing the rule in a more practicable manner and/or to clarify I/M requirements that already exist. None of these amendments impose any additional burdens beyond that already imposed by applicable federal law; thus, today's action is not subject to the requirements of sections 202 and 205 of the UMRA and EPA has not prepared a statement with respect to budgetary impacts.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. The Clean Air Act requires I/M to apply in certain non-attainment areas as a matter of law, and this action merely provides areas newly designated as non-attainment under the 8-hour ozone standard additional flexibility with regard to meeting their existing statutory obligations. Thus, Executive Order 13132 does not apply to this rule.

Executive Order 13175: “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 6, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” The phrase “policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.”

Today's amendments to the I/M rule do not significantly or uniquely affect the communities of Indian tribal governments. Specifically, today's action incorporates into the I/M rule flexible provisions addressing newly designated 8-hour ozone non-attainment areas subject to I/M requirements under the Act, and these provisions do 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. Accordingly, the requirements of Executive Order 13175 are not applicable to this action.

Executive Order 13045: “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, the Agency must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency.

Today's action is not subject to Executive Order 13045 because it is not economically significant within the meaning of Executive Order 12866 and does not involve the consideration of relative environmental health or safety risks.

This rule is not subject to Executive Order 13211, “Action Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355; May 22, 2001) because it will not have a significant adverse effect on the supply, distribution, or use of energy. Further, we have determined that this action is not likely to have any significant adverse effects on energy supply.

Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

Today's action does not involve technical standards. Therefore, the use of voluntary consensus standards does not apply to this action.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit this final rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the final rule in the Federal Register. This rule is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective on May 8, 2006.

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by June 6, 2006. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review, nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such a rule or action. This action may not be challenged later in proceeding to enforce its requirements. (See section 307(b)(2) of the Administrative Procedures Act.)

Regulated Entities. The regulated categories and entities affected by the national emission standards include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by the national emission standards. To determine whether your facility would be affected by the national emission standards, you should examine the applicability criteria in 40 CFR 63.360. If you have any questions regarding the applicability of the national emission standards to a particular entity, consult either the air permit authority for the entity or your EPA regional representative as listed in 40 CFR 63.13.

Worldwide Web (WWW). In addition to being available in the docket, an electronic copy of today's final decision will also be available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of the final decision will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at the following address: http://www.epa.gov/ttn/oarpg/. The TTN provides information and technology exchange in various areas of air pollution control.

Judicial Review. Under Clean Air Act (CAA) section 307(b)(1), judicial review of this final decision is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by June 6, 2006. Under section 307(d)(7)(B) of the CAA, only an objection to a rule or procedure raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by the final decision may not be challenged separately in civil or criminal proceedings brought to enforce these requirements.

Section 307(d)(7)(B) of the CAA further provides that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for us to convene a proceeding for reconsideration, “[i]f the person raising an objection can demonstrate to the EPA that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a copy to both the person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20004.

Outline. The information presented in this preamble is organized as follows:

Section 112 of the CAA establishes a comprehensive regulatory process to address hazardous air pollutants (HAP) from stationary sources. In implementing this process, we have identified categories of sources emitting one or more of the HAP listed in the CAA, and ethylene oxide sterilization facilities are identified as both major and area source categories. Section 112(d) requires us to promulgate national technology-based emission standards for sources within those categories that emit or have the potential to emit any single HAP at a rate of 10 tons or more per year or any combination of HAP at a rate of 25 tons or more per year (known as major sources), as well as for certain area sources emitting less than those amounts. These technology-based national emission standards for HAP (NESHAP) must reflect the maximum reductions of HAP achievable (after considering cost, energy requirements, and nonair health and environmental impacts) and are commonly referred to as maximum achievable control technology (MACT) standards. We promulgated the National Emission Standards for Ethylene Oxide Commercial Sterilization and Fumigation Operations Facilities at 59 FR 62585 on December 6, 1994 (Ethylene Oxide Sterilization NESHAP). As for area sources, we established MACT standards for certain emission points pursuant to section 112(d)(2) and generally available control technology (GACT) standards for other emission points pursuant to section 112(d)(5).

In what is referred to as the technology review, we are required under section 112(d)(6) of the CAA to review these technology-based standards no less frequently than every 8 years. Further, if we conclude that a revision is necessary, we have the authority to revise these standards, taking into account “developments in practices, processes, and control technologies.”

The residual risk review is described in section 112(f) of the CAA. Section 112(f)(2) requires us to determine for each section 112(d) source category, except area source categories for which we issued a GACT standard, whether the NESHAP protects public health with an ample margin of safety (AMOS). If the NESHAP for HAP “classified as a known, probable, or possible human carcinogen do not reduce lifetime excess cancer risks to the individual most exposed to emissions from a source in the category or subcategory to less than one in one million,” we must decide whether additional reductions are necessary to provide an ample margin of safety. As part of this decision, we may consider costs, technological feasibility, uncertainties, or other relevant factors. We must determine whether more stringent standards are necessary to prevent adverse environmental effect (defined in section 112(a)(7)) as “any significant and widespread adverse effect, which may reasonably be anticipated to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas,” but in making this decision we must consider cost, energy, safety, and other relevant factors.

We promulgated the Ethylene Oxide Sterilization NESHAP in 1994. On October 24, 2005 (70 FR 61406), we proposed not to revise the Ethylene Oxide Sterilization NESHAP and requested public comments on the residual risk and technology review for the Ethylene Oxide Sterilization NESHAP.

In our proposal, we presented the analysis and conclusions on residual risk and technology review, concluding that the maximum individual cancer risk for this source category already meets the level we generally consider acceptable, and that further control requirements would achieve, at best, minimal emission and risk reductions at a very high cost from emission vents controlled with MACT at both major and area sources. Further, the analyses showed that both the chronic noncancer and acute risks from this source category are below their respective relevant health thresholds, and that there are no adverse impacts to the environment (i.e., ecological risks). As a result, we concluded that no additional control should be required because an ample margin of safety (considering cost, technical feasibility, and other factors) has been achieved by the NESHAP MACT requirements for the ethylene oxide major and area source categories.

In the technology review, we concluded that additional controls at existing sources would achieve, at best, minimal emission and risk reductions at a very high cost. Additionally, we did not identify any significant developments in practices, processes, or control technologies since promulgation of the original standards in 1994 which represent the best controls that can be implemented nationally. Thus, we proposed no additional controls under the technology review under CAA section 112(d)(6).

We conclude in this rulemaking, as proposed, that there is not a need to revise the Ethylene Oxide Sterilization NESHAP under the provisions of CAA section 112(f) or 112(d)(6).

The proposal provided a 45-day comment period ending December 8, 2005. We received comments from eight commenters. Commenters included three State agencies, one State and local agency association, three industry trade associations, and one coalition of trade associations. We have considered the public comments as discussed below and did not find that the comments changed any of our determinations.

Comment: One commenter disagreed that EPA can utilize approaches different from that specified in the Benzene NESHAP. The commenter believes that EPA misinterpreted the CAA legislative history stating that EPA could read section 112(f)(2)(B) as directing it to use the interpretation set out in the Benzene NESHAP or use approaches affording the same level of protection. According to the commenter, EPA must use only the Benzene NESHAP approach and cannot use any other approach by relying on a Senate manager's statement that EPA should interpret the section 112(f)(2)(B) requirement to establish standards reflecting an ample margin of safety in a manner no less protective of the most exposed individual than the policy set forth in the Benzene NESHAP.

Response: In the proposed rule, EPA followed the approach set out in National Emission Standards for Hazardous Air Pollutants (NESAHP): Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene/Styrene Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By-Product Recovery Plants, 54 FR 38044 (September 14, 1989). EPA used the two-step decision process of first determining a level of acceptable risk followed by finding an ample margin of safety. As the commenter concedes EPA's approach is fully consistent with the Benzene NESHAP approach and therefore acceptable. Since, in this instance, EPA did not use any other approach, the comment is not applicable to this particular rulemaking.

Comment: One commenter stated that Congress was clear in requiring EPA to evaluate only the risks from an individual source category or subcategory in establishing residual risk standards. The commenter stated EPA should not include the risk from area sources in determining whether risks from the major source category exceeds the one-in-a-million risk trigger under section 112(f)(2) or in making judgments on acceptable risk and ample margin of safety for major sources.

Response: We listed separate source categories for major and area commercial sterilization facilities under section 112(c) of the CAA, and we agree with the commenter that a separate determination of acceptable risk and ample margin of safety should be made for each source category under section 112(f) of the CAA. Our risk assessment for commercial sterilization facilities includes risk estimates for all known sources, including mostly major sources and the area sources with the highest emissions. Only two area sources have estimated cancer risk greater than 1 in 1 million (highest is 20 in 1 million), and no area sources have modeled ethylene oxide concentrations near the reference concentration. For additional information on our risk assessment of area sources see section III.2.

In the preamble to the proposed rule, we stated that risks were acceptable considering all known sources (major and area sources) and that an ample margin of safety was achieved without control requirements beyond those in the current standards. Although the preamble to the proposed rule does not discuss separate determinations of acceptability and ample margin of safety for major and areas source categories, our conclusions would not have changed whether we had considered all sources together, or separately for major sources and area sources.

Comment: One commenter stated that EPA did not comprehensively consider the plants' impacts because it did not consider all HAP emissions or all source categories at the facilities. The commenter stated that in considering only a portion of the facilities' emissions, the determination of low-risk is based on a distorted and unrealistic view of their impact. The commenter included an example of a facility that uses and emits methyl bromide from its sterilization operations.

Response: In general, there is much less co-location of commercial sterilization operations with other industrial processes than there is for the typical source category. Many facilities are contract sterilizers with no co-location. In some cases, there is co-location of commercial sterilizers with other processes, such as pharmaceuticals production. We do not have sufficiently detailed information to analyze the possibility of controls on the various specific sources within a facility but outside the commercial sterilizer source category. As a result, we could not evaluate the existing levels of control or the potential for applying additional controls at the facilities where HAP emissions from other sources contribute to the risk. Therefore, we did not consider emissions from co-located sources in our decision to require no additional controls because we did not have the control cost and feasibility data necessary to do so. Our position on the potential consideration of co-located source categories is fully discussed in the coke oven final rule (70 FR 19995-19998).

Regarding emissions of methyl bromide, we searched the 1999 National Emissions Inventory (NEI) for the 76 identified ethylene oxide sterilization facilities to determine which emit both ethylene oxide and methyl bromide. According to the NEI data base, only two of the facilities emit both HAP. One of the facilities emits so little methyl bromide that the risk estimates would not be significantly different if methyl bromide were considered. The other facility emits more methyl bromide than ethylene oxide (about 2 to 3 times as much). However, because there is no cancer unit risk estimate for methyl bromide, the emissions of methyl bromide would not affect our cancer risk estimate (3 in 1 million). Considering effects other than cancer, the reference concentration for chronic inhalation exposures to methyl bromide is approximately six times lower than that of ethylene oxide. Consequently, the methyl bromide emissions could result in an increase in our estimate of the hazard index for the facility by as much as a factor of 20 (assuming similar source release parameters like stack height, etc.). This is not a concern because our current estimate of the hazard index is 0.001, and a factor greater than 1000 would be necessary before a hazard index of 1 would be exceeded. Therefore, even considering these emissions would not change our regulatory decision.

Comment: One commenter stated EPA should not conduct a separate technology review for ethylene oxide sources under section 112(d)(6). The commenter believes that once EPA has made a residual risk determination under section 112(f), emissions from the category are “safe,” and the Agency must find a revision of the MACT standard under section 112(d)(6) is unnecessary. Another commenter urges EPA to avoid expenditure of resources by conducting further analysis geared to tightening control requirements when an AMOS has already been provided by a protective standard.

Response: As discussed in the preamble to the proposed rule, we performed a separate technology review for both the area and major source categories under section 112(d)(6), but recommended no changes to the NESHAP. It is possible that future advances in control technologies for this source category could allow for meaningful emission reductions at a reasonable cost. We believe that the technology review required under section 112(d)(6) was appropriate here.

Comment: One commenter believes that there is no mechanism to revisit section 112(f) assessments and, therefore, that the risk assessment should be corrected to account for reasonably foreseeable changes that could result in increased risk, such as new residences being built closer to the facility, or increases in actual emissions within the current permit limitations.

Response: We disagree with the commenter's assertion that there is no mechanism to revisit risks from the source category, and that, therefore, the risk assessment must include consideration of foreseeable changes that may occur in the future. We have the authority to revisit (and revise, if necessary) any rulemaking if there is sufficient evidence that changes within the affected industry or significant improvements to science suggests the public is exposed to significant increases in risk as compared to the risk assessment prepared for the rulemaking (e.g., CAA section 301).

Comment: One commenter stated that EPA has discretion to not regulate MACT or GACT area sources under section 112(f). One commenter stated that EPA has the discretion under section 112(f)(5) of the CAA to avoid residual risk analysis for area sources subject to GACT, regardless of whether such sources are subject to both MACT and GACT under section 112(d). The commenter reasoned that since the CAA does not require residual risk analysis of area sources subject to GACT only, area sources subject to more stringent requirements under both MACT and GACT should also not require analysis. Two commenters stated that EPA should not omit sources subject to GACT from the residual risk analysis because it could result in serious underestimation of the health risks from area sources. One commenter believes that both section 112(d) and 112(f) of the CAA were satisfied when area sources were addressed under section 112(d)(5); since GACT controls alone would have been sufficient for EPA to avoid a residual risk review, clearly requiring both MACT and GACT controls obviates the need for any further Agency review of these area sources under both 112(d) and 112(f).

Response: For area source ethylene oxide sterilizers, EPA issued MACT standards under section 112(d)(2) for sterilizer vents and chamber exhaust vents and GACT standards for aeration room vents. EPA undertook a section 112(f)(2) analysis for area source emissions standards that were issued as MACT standards and exercised its discretion under section 112(f)(5) to not do an 112(f)(2) analysis for those emission points for which GACT standards were established. EPA appreciates the responses to its question regarding the range of discretion that the Agency has under section 112(f)(5) and will consider the points made by commenters in developing future relevant proposals. However, for purposes of this rulemaking, EPA believes that it exercised its discretion appropriately by conducting a 112(f)(2) analysis for those emission points subject to MACT standards.

Comment: Two commenters stated that EPA must use the best available science to establish a cancer unit risk estimate for ethylene oxide, and that it is scientifically indefensible for EPA to use the California Environmental Protection Agency cancer unit risk factor in risk assessments when more recent epidemiological data exist. One commenter states that the basis for the California unit risk factor (mononuclear leukemia in female rats) is not relevant to humans. One commenter states that a sound scientific estimate of the cancer unit risk for ethylene oxide has been derived by Kirman, et al. 1 based partly on two epidemiological studies 2 3 that include exposure estimates for more than 20,000 workers. Two commenters stated that EPA should plan to reevaluate the risks associated with this source category whenever the new cancer risk estimate is made final, regardless of whether or not the final rule has been published.

Response: In estimating potential excess cancer risk associated with ethylene oxide sterilizers, EPA has considered all available, credible, and relevant information. In 1985, the EPA health assessment for ethylene oxide 4 concluded, based on the information available at that time, that ethylene oxide is “probably carcinogenic to humans,” and derived a cancer unit risk estimate. California EPA subsequently relied on the EPA assessment in developing their cancer unit risk estimate using the same rat study as basis.5 6 The California EPA assessment received concurrence from their Scientific Review Panel.7 In 1994, the International Agency for Research on Cancer categorized ethylene oxide in their Group 1 (Carcinogenic to Humans). In 2000, the United States Department of Health and Human Services revised its listing for ethylene oxide to “known to be a human carcinogen” in the Ninth Report on Carcinogens.8 Support for this listing includes epidemiological evidence from studies of workers exposed to ethylene oxide and animal studies. Cancer in both human and animal studies has included multiple sites, including reported associations with leukemia.9

Regulated Entities. The regulated categories and entities affected by the national emission standards for hazardous air pollutants (NESHAP) include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by the Magnetic Tape NESHAP. To determine whether your facility would be affected by the Magnetic Tape NESHAP, you should examine the applicability criteria in 40 CFR part 63.701(a) of subpart EE (NESHAP for Magnetic Tape Manufacturing Operations). If you have any questions regarding the applicability of the Magnetic Tape NESHAP to a particular entity, contact Mr. Leonard Lazarus, U.S. EPA, Office of Enforcement and Compliance Assurance, Office of Compliance, Air Compliance Branch (2223A), Ariel Rios Building, 1200 Pennsylvania Avenue, NW., Washington, DC 20460; telephone number: (202) 564-6369; fax number: (202) 564-0050; e-mail address: lazarus.leonard@epa.gov.

World Wide Web (WWW). In addition to being available in the docket, an electronic copy of today's final action will also be available on the World Wide Web through the Technology Transfer Network (TTN). Following signature, a copy of the final action will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at the following address: http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control.

Judicial Review. Under section 307(b)(1) of the CAA, judicial review of this final decision is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by June 6, 2006. Under section 307(d)(7)(B) of the CAA, only an objection to a rule or procedure raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by the final decision may not be challenged separately in civil or criminal proceedings brought to enforce these requirements.

Section 307(d)(7)(B) of the CAA further provides that “only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for us to convene a proceeding for reconsideration, “if the person raising an objection can demonstrate to the EPA that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to us should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a copy to both the person(s) listed in the preceding FOR FURTHER INFORMATION CONTACT section, and the Associate General Counsel for the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave., NW., Washington, DC 20004.

Outline. The information presented in this preamble is organized as follows:

Section 112 of the Clean Air Act (CAA) establishes a two-stage regulatory process to address emissions of hazardous air pollutants (HAP) from stationary sources. In the first stage, after EPA has identified categories of sources emitting one or more of the HAP listed in the CAA, section 112(d) calls for us to promulgate national technology-based emission standards for sources within those categories that emit or have the potential to emit any single HAP at a rate of 10 tons or more per year or any combination of HAP at a rate of 25 tons or more per year (known as “major sources”), as well as for certain “area sources” emitting less than those amounts. These technology-based standards must reflect the maximum reductions of HAP achievable (after considering cost, energy requirements, and non-air health and environmental impacts) and are commonly referred to as maximum achievable control technology (MACT) standards. For area sources, CAA section 112(d)(5) provides that, in lieu of MACT, the Administrator may elect to promulgate standards or requirements which provide for the use of generally available control technologies or management practices, and such standards are commonly referred to as generally available control technology (GACT) standards.

The EPA is then required to review these technology-based standards and to revise them “as necessary, taking into account developments in practices, processes and control technologies,” no less frequently than every 8 years.

The second stage in standard-setting is described in section 112(f) of the CAA. This provision requires that EPA prepare a Report to Congress describing, among other things, methods of estimating risks posed by sources after implementation of the MACT standards, the public health significance of those risks, the means and costs of controlling them, actual health risks to persons in proximity to emitting sources, and recommendations as to legislation regarding such remaining risk. The EPA prepared and submitted this report (“Residual Risk Report to Congress,” EPA-453/R-99-001) in March 1999. The Congress did not act on any of the recommendations in the report, triggering the second stage of the standard-setting process, the residual risk stage. Section 112(f)(2) requires us to determine for each section 112(d) source category, except area source categories for which we issued a generally available control technology standard, whether the NESHAP protects public health with an ample margin of safety. If the NESHAP for HAP “classified as a known, probable, or possible human carcinogen do not reduce lifetime excess cancer risks to the individual most exposed to emissions from a source in the category or subcategory to less than one in one million,” we must decide whether additional reductions are necessary to provide an ample margin of safety. As a part of this decision, we may consider costs, technological feasibility, uncertainties, or other relevant factors. We must determine whether more stringent standards are necessary to prevent an adverse environmental effect (defined in section 112(a)(7) as “any significant and widespread adverse effect, which may reasonably be anticipated to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas”), but in making this decision we must consider cost, energy, safety, and other relevant factors.

On December 15, 1994, we promulgated the NESHAP for Magnetic Tape Manufacturing Operations (59 FR 64580) and required existing sources to comply with the NESHAP by December 15, 1996.

The Magnetic Tape NESHAP covers HAP emissions from surface coatings used in the manufacture of magnetic and optical recording media used in audio, video, computer and magnetic stripe tape and disks. The emission units regulated by the Magnetic Tape NESHAP are storage tanks, mix preparation equipment, coating operations, waste handling devices, condenser vents in solvent recovery, particulate transfer operations, wash sinks for cleaning removable parts, equipment for flushing fixed lines, and wastewater treatment operations. The Magnetic Tape NESHAP regulates only those sources located at major sources. During the development of the NESHAP, we identified 25 existing magnetic recording media and magnetic stripe facilities, of which 14 were considered major and, therefore, subject to the NESHAP. Currently, there are only six magnetic tape manufacturing facilities remaining in the United States, all of which are major.

In general, the current NESHAP requires an overall HAP control efficiency of at least 95 percent for emissions from each solvent storage tank, piece of mix preparation equipment, coating operation, waste handling device, or condenser vent in solvent recovery. If an incinerator is used to control these emissions points, an outlet HAP concentration of no greater than 20 parts per million by volume by compound may be met, instead of achieving 95 percent control, as long as the efficiency of the capture system is 100 percent. If a coating with a HAP content no greater than 0.18 kilograms per liter (1.5 pounds per gallon) of coatings solids is used, that coating operation does not require further control.

Several solvents and particulate HAP are used in the magnetic tape manufacturing industry. Currently, the solvents used to the greatest extent are methyl ethyl ketone (MEK) and the HAP toluene, and the particulate HAP are cobalt and cobalt compounds. At the time of promulgation of the NESHAP, however, the solvents in use included MEK, cyclohexanone, acetone, and isopropyl alcohol and the HAP toluene, methyl isobutyl ketone, toluene diisocyanate, ethylene glycol, methanol, xylenes, ethyl benzene, and acetaldehyde; and the particulate HAP included chromium, cobalt, and their respective compounds. Several of these compounds are no longer used in the industry. The compound MEK and the HAP toluene are used at all facilities. At the time of promulgation of the magnetic tape NESHAP, MEK was a listed HAP, and we estimated that HAP emissions, including MEK and toluene, would be reduced by 2,080 megagrams per year (Mg/yr) (2,300 tons per year (tpy)) from a baseline of 4,060 Mg/yr (4,470 tpy). Methyl ethyl ketone was later delisted by EPA in 70 FR 75047, December 19, 2005.

As required by section 112(f)(2) of the CAA, we prepared a risk assessment to determine the residual risk posed by magnetic tape manufacturing operations after implementation of the NESHAP. We compiled a list of the six magnetic tape manufacturing facilities still in operation in the United States based on inventory information we gathered from a number of manufacturing facilities and State environmental program offices (e.g., whether these facilities were still operating and manufacturing magnetic tape).

The major compounds emitted by the magnetic tape manufacturing source category are MEK and the HAP toluene, which comprise 97 percent, by tpy, of all emissions in the source category. The six magnetic tape manufacturing facilities have MEK and HAP emissions ranging from 3.9 to 214 Mg/yr (4.3 to 236 tpy). At the time of proposal, MEK was a listed HAP, and the nationwide annual HAP emissions, including MEK and toluene, were estimated to be 468 Mg/yr (516 tpy). Methyl ethyl ketone has since been delisted.

Using these data, we modeled exposure concentrations surrounding the six facilities, calculated the risk of possible chronic cancer and noncancer health effects, evaluated whether acute exposures might exceed relevant health thresholds, and investigated human health multipathway and ecological risks.

The emissions data used in the residual risk assessment represent actual levels of emissions for the base year. We have no reason to believe that there is a substantial amount of over control compared to what is allowed under the MACT standard. Therefore, the results of the risk assessment represent our approximation of the maximum risks which would be allowed under compliance with the NESHAP.

Consistent with the tiered modeling approach described in the Residual Risk Report to Congress of March 1999 (EPA-453/R-99-001), the risk assessment for this source category started with a simple assessment, which used health-protective assumptions in lieu of site-specific data. The results demonstrated negligible risks for potential chronic cancer, chronic noncancer, and acute noncancer health endpoints. Also, no significant human health multipathway or ecological risks were identified. Had the resulting risks been determined to be non-negligible, a more refined analysis with site-specific data would have been necessary.

The assessment is described in detail in the memorandum “Residual Risk Assessment for the Magnetic Tape Manufacturing Source Category,” available in the docket. Since our assessment shows that sources subject to the Magnetic Tape Manufacturing NESHAP pose maximum lifetime excess cancer risks which are significantly less than 1 in 1 million, EPA concluded that public health is protected with an ample margin of safety, and since noncancer health risks and ecological risks were also found to be insignificant for this source category, EPA is not obligated to adopt standards under section 112(f) of the CAA. Because risks contributed by MEK are a negligible part of the overall risk, the delisting of MEK has essentially no effect on the risk assessment performed for the proposed rule.

Section 112(d)(6) of the CAA requires EPA to review, and revise as necessary (taking into account developments in practices, processes, and control technologies), emission standards promulgated under section 112 no less often than every 8 years. As we stated in the preamble to the Coke Ovens residual risk rule (70 FR 20009), and as discussed below, the facts underlying a section 112(f) determination should be key factors in making any subsequent section 112(d)(6) determinations. For this and several other source categories, we were under consent decree deadlines to complete both the section 112(d)(6) technology review and the section 112(f)(2) residual risk analysis by the same date. As a result, we conducted the two reviews concurrently and did not have the results of the section 112(f)(2) analysis before we began the section 112(d)(6) technology review.

We reviewed available information about the industry, talked with industry representatives, and contacted several facilities in the industry to investigate available emission control technologies and the potential for additional emission reductions. We did not identify any additional control technologies beyond those that are already in widespread use within the source category (e.g., carbon adsorbers, condensers). The only developments identified involve improvements in the performance of existing technologies or increased frequency of inspections and testing, which would achieve only small incremental emission reductions. However, we did discover that new product developments (optical recording media and solid state recording media) may eventually supplant magnetic tape, but these media are not considered magnetic tape and would not be covered under the Magnetic Tape NESHAP. Therefore, our investigation did not identify any significant developments in practices, processes, or control technologies in the magnetic tape manufacturing industry since promulgation of the original standards in 1994. We undertook the technology assessment for this source category consistent with our policy in the Coke Ovens residual risk rule (70 FR 20008-20009).

On October 24, 2005, based on the findings from our residual risk and technology review, we proposed no further action to revise the NESHAP (70 FR 61417) and requested public comment.

Today's final action responds to public comments received on the proposed action and announces our final decision not to revise the standards.

In the proposed action, we requested public comment on our residual risk review and our technology review and on issues of delisting the source category and conducting future technology reviews. By the end of the public comment period, comments from five entities had been received. A summary of these comments and EPA's responses are provided in the sections below.

Comment: Three commenters supported EPA's decisions for the magnetic tape source category. The commenters supported EPA's conclusion that no changes to the existing NESHAP for magnetic tape manufacturing were required to satisfy the requirements of section 112(f). The commenters noted that EPA correctly reviewed the magnetic tape sources, followed the tiered risk assessment approach described in its Residual Risk Report to Congress, and, using a conservative methodology, determined that no source in the category had a maximum individual cancer risk exceeding the 1-in-1-million level for triggering promulgation of a residual risk standard under section 112(f).

Two of the commenters stated that EPA was correct to focus its section 112(f) residual risk analysis on the sources in the magnetic tape source category subject to section 112(d) requirements, and not consider risk from outside that source category. According to the commenters, the statutory language and construction of section 112(f) shows that Congress was directing EPA to perform residual risk analyses for individual source categories.

Response: We acknowledge the commenters' support for our health-protective methodology and our conclusions in the proposed notice. However, we do not agree that our section 112(f) residual risk analyses must always focus only on the sources in the category subject to section 112(d) requirements or that Congress intended to limit all residual risk analyses to the individual source categories in question. As we stated in the preamble to the Coke Ovens residual risk rule, “EPA disagrees that section 112(f) precludes EPA from considering emissions other than those from the source category or subcategory entirely.” Rather, we have concluded that, when the statutory risk trigger is exceeded, the two-step approach set forward in the Benzene NESHAP remains the approach that we should follow in determinations under section 112(f). At the first step, when determining “acceptable risk,” we will consider risks that result from emissions from the source category only. However, during the second step, we must determine whether additional reductions should be required to protect public health with “an ample margin of safety.” One of the factors that we can consider in this second step is environmental levels of HAP due to emissions from sources outside the source category being assessed. This could include ambient background concentrations of HAP, as well as co-location of other emission sources that augment the identified risks from the source category.

At proposal, we requested comment on whether it would be appropriate to delist the magnetic tape source category under section 112(c)(9) based on the possibility that HAP emissions from the source category would be sufficiently low even in the absence of MACT standards.

Comment: One commenter opposed delisting the magnetic tape source category, stating that if the source category was delisted, there would be nothing to prevent sources from increasing their HAP emissions substantially or changing their processes to emit new HAP, resulting in HAP levels unacceptable to public health and the environment. The commenter indicated that such an approach ignores the possibility that HAP emissions were reduced to an acceptable level because of the MACT requirements and that emissions could increase again without the MACT standard in place. Furthermore, the commenter believed that Congress did not intend for the residual risk review to result in delisting of regulated source categories; if Congress had wanted to make delistings dependent on or linked to the outcome of the residual risk process, it would have specifically mandated this in the CAA, which it did not.

Two commenters argued that delisting a source category does not affect the applicability of an existing NESHAP and cited the delisting action following the Asbestos NESHAP as support for their argument. They also noted that EPA said in its proposal that no further section 112(d)(6) reviews are required unless there is a significant change to the source category. Consequently, the commenters saw no benefit in delisting the magnetic tape source category. However, they were not opposed to such an action.

One commenter supported delisting the magnetic tape source category under the authority of section 112(c)(9) based on EPA's finding of negligible risks (0.01 in 1 million). The commenter stated that EPA's request for comment implied that it interpreted the CAA to allow delisting on the basis of low risk only before a MACT standard is issued; however, section 112(c)(9) provides EPA with the authority to delist a source category whenever the Administrator makes a determination that the risks are below the risk criteria in the CAA and does not limit this authority to sources not yet subject to a MACT or GACT standard. According to the commenter, limiting EPA's discretion to delist source categories prior to issuing MACT or GACT standards also conflicts with the required sequence of duties under section 112, which does not require EPA to conduct a risk analysis until a residual risk evaluation is required 8 years after MACT standards are issued; consequently, EPA is unlikely to have sufficient data on which to base a delisting decision until many years after MACT standards have been promulgated. Furthermore, the commenter stated it is possible that source categories found to be low-risk after MACT standards were imposed may have been low-risk before the standards were imposed, especially magnetic tape facilities, where the risk assessment showed risks two orders of magnitude below the statutory criteria for delisting under section 112(c)(9). Finally, the commenter noted that if EPA was concerned that the source category would exceed risk levels if MACT controls were not applicable, it could use section 112(c)(9) to keep in place those MACT requirements needed to sustain the low-risk determination and delisting. According to the commenter, those requirements could be established as part of the delisting decision and maintained in the title V permit, as was done in the NESHAP for Plywood and Composite Wood Products.

Response: Based on our risk assessment of the magnetic tape source category, we have concluded that these sources are low-risk and, therefore, that no further standards are required to protect public health with an ample margin of safety or to protect the environment. However, we agree with the commenter who argues that this conclusion is based, at least in part, on the fact that the MACT requirements for these sources limit HAP emissions. Further, we disagree with the comment that delisting will not affect the viability of the existing NESHAP. The commenter cited the delisting action following the Asbestos NESHAP as support for their argument, noting that the applicability of that rule was not affected by delisting. However, the Asbestos NESHAP was established under part 61, which is not directly relevant in this situation since the Magnetic Tape NESHAP is a part 63 rule. If we delist this source category, it is our conclusion that existing magnetic tape sources would no longer be subject to the NESHAP and, thus, HAP emissions would no longer be limited by this rule. If sources begin emitting HAP at levels exceeding those allowed under the NESHAP, risks could increase, and the basis for our finding that the source category is low-risk could be compromised. We have already documented that emissions from magnetic tape manufacturing operations were substantially higher at promulgation, compared to more recent emissions estimates (after the standards were implemented). As noted in the October 24, 2005 proposal (70 FR 61419) and previously in this action, HAP emissions at promulgation were estimated to be 4,060 Mg/yr (4,470 tpy), while HAP emissions in 2000 were estimated to be 468 Mg/yr (516 tpy)—a difference of almost 90 percent, some of which is due to compliance with the MACT standard and some of which is due to 19 plant closures since 1994. These HAP emissions estimates include MEK, which has since been delisted as a HAP. More recent information suggests that the delisting of MEK may result in one plant reducing its emissions to below the major source levels. If the potential-to-emit limit for this facility is below the major source threshold due to the delisting of MEK, it would become an area source and as such would no longer be subject to the magnetic tape manufacturing NESHAP. Nonetheless, since compliance with the MACT standard is part of the basis for our low-risk determination, we believe that our policy objectives are best served if we do not delist the magnetic tape source category.

Contrary to one commenter's contention, we did not intend to imply through our request for comments that we interpret section 112(c)(9) of the CAA to apply only before a MACT standard has been promulgated. We were simply seeking comment on the use of section 112(c)(9) after the MACT standard. However, for the reasons presented above, we have decided not to use section 112(c)(9) to delist the magnetic tape source category.

The Agency would like to remove the burden of the repetitive review of Section 112 standards for low risk source categories. At the same time, we think it is appropriate to maintain the MACT controls, in this case. We plan to further investigate approaches for removing low-risk source categories from the Section 112 universe while maintaining MACT-level controls. An example of a similar approach is found in the Plywood and Composite Wood Products MACT where we allow a subcategory of facilities to reduce emissions to acceptable risk levels through Title 5 permits and remove them from the MACT universe.

At proposal, we requested comment on “the notion that, barring any unforeseeable circumstances which might substantially change this source category or its emissions, we would have no obligations to conduct future technology reviews under CAA section 112(d)(6).” We suggested this approach because of the low-risk finding for this source category under section 112(f).

Comment: One commenter disagreed that low risk from a source category at this time should absolve EPA of its obligation to conduct future technology reviews. The commenter stated that, without periodic reviews of source categories and technology in the future reviews, EPA would not be aware of any technologies that have been developed or any “unforeseeable circumstances” related to the source category to which EPA refers in the notice. Furthermore, the commenter believed that Congress did not intend for the residual risk review to result in the removal of EPA's obligation to conduct future technology reviews under section 112(d)(6); if Congress had wanted to make technology reviews dependent on or linked to the outcome of the residual risk process, it would have specifically mandated this in the CAA, which it did not.

Three commenters stated that EPA has no obligation to conduct a technology review in the case of Magnetic Tape. According to the commenters, because the residual risk provisions of the CAA were not triggered by the magnetic tape source category's remaining low risk, even an initial technology review was unnecessary. The commenters noted that EPA only used the results of the section 112(f)(2) residual risk analysis to conclude that future section 112(d)(6) technology reviews would not be required. The commenters stated that EPA's use of a formal technology review as the basis for its conclusion under section 112(d)(6) that the NESHAP did not need to be revised was inconsistent with EPA's prior stated position in the Coke Ovens residual risk rule (70 FR 20009) on determining the need for a technology review under section 112(d)(6). One commenter stated that if the Coke Ovens criteria for when a technology review is not “necessary” under the CAA are sound for subsequent technology reviews, then they are also sound for initial reviews, as in the case of Magnetic Tape. Another commenter stated that, where the ample margin of safety set in the residual risk rule is largely based on cost or technical feasibility, then further future review under section 112(d)(6) may remain viable, and additional controls may not be precluded if feasible, cost-effective control measures are identified in the future.

Response: We stated in the preamble to the Coke Ovens residual risk rule that if the ample margin of safety analysis for the section 112(f) standard is not based at all on the availability or cost of particular control technologies, then advances in air pollution control technology should not justify revising the MACT standard pursuant to section 112(d)(6) because the section 112(f) standard would continue to assure an adequate level of safety. We agree that a technology review is required every 8 years. However, if the ample margin of safety analysis for a section 112(f) standard shows that remaining risk for non-threshold pollutants falls below 1 in 1 million and for threshold pollutants falls below a similar threshold of safety, then further revision should not be needed because an ample margin of safety has already been assured. In these situations, it is difficult to conceive of a case where the development of new technology, or of inexpensive control strategies, would cause us to require additional requirements for a source category. If the availability and/or costs of technology are part of the rationale for the ample margin of safety determination, it is reasonable to conclude that changes in those costs or in the availability of technology could alter our conclusions regarding the ample margin of safety. For this reason, we agree with the comment that subsequent technology reviews would be appropriate and revisions may also be appropriate if the ample margin of safety established by the residual risk process considers cost or technical feasibility.

We disagree with the comment that we should not have conducted an initial technology review under section 112(d)(6) for the magnetic tape source category. As we noted in the preamble to the Coke Ovens residual risk rule, we believe that the findings that underlie a section 112(f) determination should be key factors in making any subsequent section 112(d)(6) determinations. As indicated by the inclusion of the word “subsequent” in this rationale, we believe that we are obligated to perform the initial section 112(d)(6) analysis. The timing requirements for the initial section 112(d)(6) analysis coincide with those for the residual risk analysis. Thus, it is appropriate for us to conduct both analyses at the same time and for the results of the risk analysis to impact future section 112(d)(6) technology reviews, even though these results do not negate either the need to perform the initial review or the need to perform subsequent reviews under section 112(d)(6).

Comment: Three commenters stated that action is not necessarily required under section 112(d)(6) even if a residual risk rule does not reduce cancer risks for all persons to a level below 1 in 1 million. Two of the commenters noted that EPA had already rejected such a “bright line” approach under section 112(f) in the Coke Ovens residual risk rule; instead, it serves as a trigger point to evaluate whether additional reductions are necessary to provide an ample margin of safety. The third commenter cited the legislative history of the 1990 amendments to the CAA as support that Congress had rejected provisions requiring sources to meet a 1-in-1-million standard. According to this commenter, EPA's proposed interpretation of section 112(d)(6) of requiring successive reviews unless sources achieve this risk level implies that sources must meet a 1-in-1-million standard to avoid future regulation, and if Congress had intended this “technology-based” downward revision of the standard, there would have been no need for section 112(f).

Noting that EPA's risk estimates are upper bound estimates that likely overstate risks, the first two commenters stated that a “bright line” approach should not be employed under section 112(d)(6) any more than it should be employed under section 112(f); instead, they stated that EPA should make determinations of whether a technology review is necessary on a case-by-case basis for each category.

The third commenter stated that section 112(d)(6) should be more appropriately viewed as a regulatory backstop authority, similar to the case-by-case “MACT hammer” provisions of section 112(j), to ensure that available advances in technology will be applied in the event EPA fails to issue residual risk standards under section 112(f). The commenter stated that once EPA has established a residual risk standard under section 112(f) that is “acceptable” or “safe” and protective with an “ample margin of safety,” then it must find that a separate revision of the MACT standard under section 112(d)(6) is not necessary.

Response: We agree with the commenters who indicated that it would be sufficient not to revise MACT standards citing section 112(d)(6) even if cancer risks are greater than or equal to 1 in 1 million. For example, it may be the case that a technology review is performed, but no change in the standard results from that review. In the preamble to the residual risk rule for Coke Ovens, we have applied a similar logic to the need for subsequent technology revisions under section 112(d)(6). As we stated in the Coke Ovens rule, if the ample margin of safety analysis for a section 112(f) standard shows that the remaining risk for non-threshold pollutants falls below 1 in 1 million and for threshold pollutants falls below a similar threshold of safety, then further revision would not be needed because an ample margin of safety has already been assured.

Comment: One commenter strongly recommended that EPA carefully lay out the context and framework of the residual risk program in the determination for each source category. The commenter stated that this was especially important because of the unique nature of the program compared to other EPA programs with which the public is familiar.

The commenter specifically recommended that EPA mention the two-stage regulatory process (MACT and residual risk) used to control HAP emissions from major stationary sources and to determine whether the MACT technology controls provide an ample margin of safety. The commenter noted that the residual risk program is different from other EPA programs, in that additional controls will be necessary for only some of the listed categories of sources, because in some cases, the cancer risk will be less than the 1-in-1-million trigger, or, if it is greater, EPA may determine that the current emission level provides the public with an ample margin of safety.

The commenter also recommended that EPA put into the proper context the relatively small contribution of major stationary sources to the risks from air toxics—about 11 percent in 1999 and expected to be even smaller as sources come into compliance with the latest MACT rules.

Finally, the commenter recommended that EPA present the risks from air toxics in context with the risks from ambient (criteria) air pollutants to make clear to the public how the air toxics risk estimates are much more conservative and to avoid any misperceptions by the public that the risk estimates for ambient air pollutants are comparable to the risk estimates for air toxics. Without a program of public education on this issue, the commenter indicated the public may incorrectly believe that the ample margin of safety decisions in the residual risk rules are less stringent than EPA knows them to be, resulting in public lawsuits against EPA's decisions or overregulation by EPA to compensate for the gap in public knowledge. The commenter recommended that EPA include preamble language in future EPA decisions describing the criteria it used to determine the ample margin of safety and presenting the incremental risk/incremental cost approach in the fuller context for the residual risk program.

Response: We agree that it is important to provide context for any residual risk rule. In the preamble of the current rule, we describe the MACT program and its impact on the magnetic tape source category. We also describe our statutory authority and our obligations to assess risks to human health and the environment under section 112(f) of the CAA, as well as the requirement to further regulate categories of sources if any of the estimated individual cancer risks exceed the statutory trigger level of 1 in 1 million.

We agree that our risk assessment for the magnetic tape source category appropriately contains a number of health-protective assumptions, resulting in a screening assessment that is designed to overestimate, rather than underestimate, risks. The results demonstrate negligible risks for potential chronic cancer, chronic noncancer, and acute noncancer health endpoints. Also, no significant human health multipathway or ecological risks were identified. Had the resulting risks been determined to be non-negligible, a more refined analysis with site-specific data would have been conducted. Such an assessment would be more data-intensive; however, it would also present a more accurate estimate of risks which could then be used as the basis for regulatory action. However, since the findings of the screening risk assessment for the magnetic tape source category were negative (i.e., the statutory cancer risk trigger level was not exceeded), it was not necessary to conduct a more refined risk assessment using more site-specific data. Since these activities were not relevant to this action, a complete discussion of them in the context of a full discussion of the residual risk program was not deemed necessary or appropriate. The details of our risk assessment can be found in the docket in the memo titled, “Residual Risk Assessment for the Magnetic Tape Manufacturing Source Category.”

Comment: According to one commenter, EPA should not have relied on the outdated unit cancer risk value for acrylonitrile contained in EPA's Integrated Risk Information System (IRIS) in conducting its residual risk assessment of the magnetic tape manufacturing industry. Although EPA concluded that there were no issues to be addressed regarding acrylonitrile because the facility emitting acrylonitrile presented a potential cancer risk of only 1 in 100 million, the commenter stated that it was inappropriate for EPA to use the acrylonitrile value in IRIS in its assessment because EPA was already aware the value was severely out-of-date. According to the commenter, the IRIS profile itself indicates that there are one or more significant new studies based on a screening-level review of the more recent toxicology literature. The commenter also noted that EPA was aware that numerous new studies had been conducted on assessing the cancer risk from acrylonitrile because its staff were briefed on an assessment of those new studies, received copies of the assessment report, and attended a peer review meeting on the report. The commenter also noted that a summary of the cancer assessment was published in October 2005.

Response: We agree that our IRIS assessment for acrylonitrile does not consider studies published after 1991, and we are currently developing an assessment that includes newer information. Our staff reviewed the assessment referenced by the commenter and determined that it has several weaknesses. First, the assessment concludes that the mode of action (MOA) is nonlinear, but does not provide evidence or analysis sufficient to demonstrate nonlinearity or to identify a nonlinear MOA. The independent peer panel that reviewed this assessment noted that the data do not allow unequivocal determination of acrylonitrile's MOA(s), and could not rule out a genotoxic MOA. Given the negligible contribution of the acrolitrile risk estimates in this assessment, we determined that it was reasonable and protective to continue to use linear low-dose extrapolation. Second, the assessment provides a supplemental linear unit risk value but bases it upon animal data rather than human data, despite the fact that adequate human data were available. Using these human data would have produced a higher inhalation unit risk estimate (i.e., closer to the current IRIS assessment value). Third, the linear unit risk value came from a reanalysis of animal data already considered in EPA's 1991 IRIS assessment for inhalation carcinogenicity, and rejected because better human data were available even then. For these reasons we concluded that the commentor's study should not be used in lieu of the current IRIS assessment.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA must determine whether a regulatory action is “significant” and, therefore, subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Executive Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, OMB has notified EPA that it considers this a “significant regulatory action” within the meaning of the Executive Order. The EPA has submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

This action does not impose any information collection burden. It will not change the burden estimates from those previously developed and approved for the existing NESHAP. However, OMB has previously approved the information collection requirements contained in the existing regulation (59 FR 64580, December 15, 1994) under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501, et seq.) and has assigned OMB control number 2060-0326 (EPA ICR No. 1678.05). A copy of the OMB approved Information Collection Request (ICR) may be obtained from Susan Auby, by mail at the Office of Environmental Information, Collection Strategies Division, U.S. EPA (2822T), 1200 Pennsylvania Avenue, NW., Washington, DC 20460, by e-mail at auby.susan@epa.gov, or by calling (202) 566-1672. A copy may also be downloaded off the Internet at http://www.epa.gov/icr. Include the ICR or OMB number in any correspondence.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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

The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

For purposes of assessing the impact of today's final action on small entities, a small entity is defined as: (1) A small business whose parent company has fewer than 500 to 1,000 employees, depending on the size definition for the affected NAICS code (as defined by Small Business Administration size standards); (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impact of today's final action on small entities, EPA has concluded that this final action will not have a significant economic impact on a substantial number of small entities. The final action will not impose any requirements on small entities. We are taking no further action at this time to revise the NESHAP.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law No. 104-4, establishes requirements for Federal agencies to assess the effect of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation of why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

The EPA has determined that the final action does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and tribal governments in the aggregate, or for the private sector in any 1 year. The rule imposes no enforceable duty on State, local, or tribal governments, or the private sector. Thus, today's final action is not subject to the requirements of sections 202 and 205 of the UMRA. In addition, EPA has determined that the final action contains no regulatory requirements that might significantly or uniquely affect small governments, because it contains no requirements that apply to such governments or impose obligations upon them. Therefore, the final action is not subject to the requirements of section 203 of the UMRA.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are 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.” Today's final action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. None of the affected facilities are owned or operated by State or local governments. Thus, Executive Order 13132 does not apply to the final action.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” The final action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effect 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 today's final action.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under Executive Order 12866 and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by EPA.

The final action is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866, and because EPA does not have reason to believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

The final action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not an economically significant regulatory action under Executive Order 12866.

Under section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law No. 104-113, § 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities, unless to do so would be inconsistent with applicable law or otherwise impractical. The VCS are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when EPA does not use available and applicable VCS.

The final action does not involve technical standards. Therefore, EPA is not considering the use of any voluntary consensus standards.

The Congressional Review Act, 5 U.S.C. 801, et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing the final action and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the final action in the Federal Register. The final action is not a “major rule” as defined by 5 U.S.C. 804(2). The effective date of this final action is April 7, 2006.

Regulated Entities. The regulated categories and entities affected by the NESHAP include:

This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by the NESHAP. To determine whether your facility would be affected by the NESHAP, you should examine the applicability criteria in 40 CFR 63.400(a) of subpart Q (IPCT NESHAP). If you have any questions regarding the applicability of the NESHAP to a particular entity, contact either the air permit authority for the entity or your EPA regional representative as listed in 40 CFR 63.13 of subpart A (General Provisions).

World Wide Web (WWW). In addition to being available in the docket, an electronic copy of today's final action will also be available on the WWW through the Technology Transfer Network (TTN). Following the Administrator's signature, a copy of the final action will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules at: http://www.epa.gov/ttn/oarpg. The TTN provides information and technology exchange in various areas of air pollution control.

Judicial Review. Under section 307(b)(1) of the Clean Air Act (CAA), judicial review of the final action is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit by June 6, 2006. Under section 307(d)(7)(B) of the CAA, only an objection to the final action amendment that was raised with reasonable specificity during the period for public comment can be raised during judicial review. Moreover, under section 307(b)(2) of the CAA, the requirements established by the final action may not be challenged separately in any civil or criminal proceedings brought by EPA to enforce the requirements.

Outline. The information presented in this preamble is organized as follows:

Section 112 of the CAA establishes a comprehensive regulatory process to address hazardous air pollutants (HAP) from stationary sources. In implementing this process, we have identified categories of sources emitting one or more of the HAP listed in the CAA, and industrial process cooling towers are identified as one such source category. Section 112(d) requires us to promulgate national technology-based emission standards for sources within those categories that emit or have the potential to emit any single HAP at a rate of 10 tons or more per year or any combination of HAP at a rate of 25 tons or more per year (known as major sources), as well as for certain area sources emitting less than those amounts. These technology-based NESHAP must reflect the maximum reductions of HAP achievable (after considering cost, energy requirements, and non-air health and environmental impacts) and are commonly referred to as maximum achievable control technology (MACT) standards.

In what is referred to as the technology review, we are required under section 112(d)(6) of the CAA to review these technology-based standards no less frequently than every 8 years. Further, if we conclude that a revision is necessary, we have the authority to revise these standards, taking into account “developments in practices, processes, and control technologies.”

The residual risk review is described in section 112(f) of the CAA. Section 112(f)(2) requires us to determine for each section 112(d) source category, except area source categories for which we issued a generally available control technology standard, whether the NESHAP protects public health with an ample margin of safety. If the NESHAP for HAP “classified as a known, probable, or possible human carcinogen do not reduce lifetime excess cancer risks to the individual most exposed to emissions from a source in the category or subcategory to less than one in one million,” we must decide whether additional reductions are necessary to provide an ample margin of safety. As part of this decision, we may consider costs, technological feasibility, uncertainties, or other relevant factors. We must determine whether more stringent standards are necessary to prevent adverse environmental effect (defined in CAA section 112(a)(7) as “any significant and widespread adverse effect, which may reasonably be anticipated to wildlife, aquatic life, or other natural resources, including adverse impacts on populations of endangered or threatened species or significant degradation of environmental quality over broad areas.”), but in making this decision we must consider cost, energy, safety, and other relevant factors.

On September 8, 1994 (59 FR 46350), we promulgated the IPCT NESHAP and required existing sources to comply with the rule requirements by March 8, 1996.

Cooling towers are devices that are used to remove heat from a cooling fluid, typically water, by contacting the fluid with ambient air. The IPCT source category includes cooling towers that are used to remove heat that is produced as an input or output of chemical or industrial processes. The IPCT source category also includes cooling towers that cool industrial processes in combination with heating, ventilation, and air conditioning (HVAC) systems. The IPCT NESHAP applies specifically to IPCT that use chromium-based water treatment chemicals and are located at major sources of HAP emissions. Standards to control chromium emissions from cooling towers that cool HVAC systems exclusively (comfort cooling towers) were promulgated under section 6 of the Toxic Substances Control Act (55 FR 222, January 3, 1990).

The primary industries that use IPCT include petroleum refineries, chemical manufacturing plants, primary metals processing plants, glass manufacturing plants, rubber products manufacturing plants, tobacco products manufacturing plants, and textile manufacturing plants. When the IPCT NESHAP were promulgated, we estimated that there were approximately 6,945 IPCT located at these plants nationwide, and that approximately 260 of these IPCT used chromium-based water treatment chemicals. We estimated that the IPCT NESHAP would reduce emissions of chromium compounds from these facilities by 22.7 megagrams per year (Mg/yr) (25 tons per year (tpy)) by prohibiting the use of chromium-based water treatment chemicals in IPCT. In addition, we estimated that the NESHAP would prevent emissions of 1.6 Mg/yr (1.8 tpy) of chromium compounds from the 870 new IPCT projected by the 5th year of the standards (1998).

When the NESHAP were promulgated, we had no information that indicated that HAP other than chromium compounds were emitted from IPCT. Consequently, we did not address emissions of other HAP in the IPCT NESHAP.

As required by section 112(f)(2) of the CAA, we prepared a risk assessment to determine the residual risk posed by IPCT after implementation of the NESHAP. To evaluate the residual risk for the IPCT source category, we identified the HAP emitted from IPCT and, as a discretionary matter in this instance, estimated worst-case emission rates for each of those HAP. These worst-case emission rates were used, along with facility parameters representing an actual facility, to perform the risk assessment.

Because the IPCT NESHAP prohibits the use of chromium-based water treatment chemicals in IPCT, we believe that chromium compound emissions from IPCT have been eliminated by the NESHAP. In assessing the residual risk for the source category, however, we also considered emissions of other HAP from IPCT.

In the absence of process leaks or malfunctions, the chemical species that are emitted from IPCT consist of the naturally-occurring constituents of the cooling water and any substances that are added to the cooling water. To determine what other HAP may be emitted from IPCT, we first contacted suppliers of cooling water treatment chemicals for information on cooling water additives that either contain HAP or form HAP, which could be emitted from IPCT. Then, we conducted a literature search for information on emissions from cooling towers. The information collected from the water treatment chemical suppliers and through the literature search indicated that some biocides used to treat industrial cooling water either contain HAP or form HAP that can be emitted from IPCT. These HAP include chloroform, methanol, and ethylene thiourea.

Industrial process cooling towers typically use one and not all of the biocides that release the three listed HAP at any given time. Therefore, IPCT emit no more than one of the three listed HAP. We estimated worst-case emission rates for chloroform, methanol, and ethylene thiourea based on the range of concentrations of these constituents in cooling water and the model plants developed for the IPCT NESHAP. We used these emission rates to model exposure concentrations surrounding those sources, calculated the risk of possible chronic cancer and noncancer health effects, evaluated whether acute exposures might exceed relevant health thresholds, and investigated human health multipathway and ecological risks.

Consistent with the tiered modeling approach described in the “Residual Risk Report to Congress” (EPA-453/R-99-001), the risk assessment for this source category started with a simple assessment which used conservative assumptions in lieu of site-specific data. The results demonstrated negligible risks for potential chronic cancer, chronic noncancer, and acute noncancer health endpoints. Also, no significant human health multipathway or ecological risks were identified. Had the resulting risks been determined to be non-negligible, a more refined analysis with site-specific data would have been necessary. The assessment is described in detail in the memorandum “Residual Risk Assessment for the Industrial Process Cooling Source Category,” which is available in the docket.

Since our assessment shows that sources subject to the IPCT NESHAP pose maximum lifetime excess cancer risks which are significantly less than 1 in 1 million, EPA concluded that public health is protected with an ample margin of safety, and since noncancer health risks and ecological risks were also found to be insignificant for this source category, EPA is not obligated to adopt standards under section 112(f) of the CAA.

Section 112(d)(6) of the CAA requires EPA to review, and revise as necessary (taking into account developments in practices, processes, and control technologies), emission standards promulgated under section 112 no less often than every 8 years. As we stated in the preamble to the Coke Ovens residual risk rule (70 FR 20009, April 15, 2005), and as discussed below, the facts underlying a section 112(f) determination should be key factors in making any subsequent section 112(d)(6) determinations. For this and several other source categories, we were under consent decree deadlines to complete both the section 112(d)(6) technology review and the section 112(f)(2) residual risk analysis by the same date. As a result, we conducted the two reviews concurrently and did not have the results of the section 112(f)(2) analysis before we began the section 112(d)(6) technology review.

For the IPCT source category, the emission standards imposed an absolute prohibition on the use of chromium-based water treatment chemicals in IPCT. As the emission standards imposed for this particular source are already at the most stringent level, no more stringent standards could be imposed. Nor has EPA received any evidence which would justify a downward revision of the standards. In the residual risk analysis discussed above, EPA has considered risks for HAP emissions that are not currently subject to emission standards but are attributable to the source category or subcategory. Since the risk from other HAP emitted from IPCT due to the addition of water treatment chemicals was determined to be very low and the emission standards already preclude the use of chromium-based water treatment chemicals, we concluded that no further controls are necessary under 112(d)(6).

On October 24, 2005 (70 FR 61411), based on the findings from our residual risk and technology review, we proposed no further action to revise the NESHAP and requested public comment.

Today's final action responds to public comments received on the proposed action and announces our final decision to amend the applicability section of the rule.

In the proposed action, we requested public comment on our residual risk review and our technology review and on issues of delisting the source category and conducting future technology reviews. By the end of the public comment period, comments from nine entities had been received. A summary of the major comments and EPA's responses are provided below in sections II.B.1 through II.B.7 of this preamble.

Comment: Two commenters urged EPA to carefully lay out the context and framework of the Residual Risk Program to ensure that the public understands the program and can adequately evaluate EPA's decisions regarding residual risk. The commenters identified several specific aspects of the program, which they believe need to be conveyed to the public. Among those, they included: the success of the MACT program in controlling HAP emissions; further regulatory steps are not required if EPA determines that existing MACT standards have provided an ample margin of safety; and the public can be assured that residual risk rules will provide such a margin of safety in those cases where the standard has not achieved an ample margin of safety. The commenters also stated that it is important for EPA to put the risks associated with major stationary sources in the proper context. The commenters stated that major stationary sources account for only a small percentage of the estimated cancer risk from HAP nationwide. In addition, they urged EPA to present risk from air toxics in context with the risks from other forms of air pollution. Specifically, they pointed out that the unit risk factors assigned to air toxics are much more conservative than the factors assigned to criteria pollutants. As a result, risk estimates for criteria pollutants should not be compared to estimates of risk based on HAP emissions from stationary sources subject to NESHAP.

Response: We agree that it is important to provide context for any residual risk rule. In this preamble, we describe the MACT program and its impact on the IPCT source category. We also describe our statutory authority and our obligations to assess risks to human health and the environment under section 112(f) of the CAA, as well as the requirement to further regulate categories of sources if any of the estimated individual cancer risks exceed the statutory trigger level of 1 in 1 million.

The risks posed by any individual major stationary source depend upon a number of factors, including emission rates at the source, proximity of exposed populations to the emission source, the specific HAP emitted, local meteorological conditions, and terrain conditions surrounding the source. Therefore, the relative contribution of a particular major stationary source to individual risk levels in its vicinity will vary dramatically depending on the local conditions at and around that specific source. This variability is not captured by the national average contribution of major sources to population risk levels mentioned by the commenter, whereas the risk assessments we perform for the purposes of evaluating residual risk are designed specifically to capture localized individual risks associated with individual sources.

We agree that our screening risk assessment for the IPCT source category appropriately contains a number of health-protective assumptions and uses health-protective inhalation risk values. The overall result is a screening assessment that is designed to overestimate, rather than underestimate, risks. The commenters make the seemingly contradictory arguments that we should both present risks from air toxics in the context of those from criteria pollutants and that it is inappropriate to make direct comparisons between assessments of risk for air toxics and criteria pollutants. Given the different goals of the residual risk program and the criteria pollutant program, we agree with their second point that estimates of risk generated for air toxics are not directly comparable to those generated for criteria pollutants.

Comment: Four commenters expressed support for EPA's tiered approach to evaluating residual risk by first performing a screening assessment, followed by a refined assessment. One commenter commented that, if a screening risk assessment based on conservative assumptions showed that risks are negligible, no further assessments or actions should be taken. All four commenters stated that EPA must proceed with the refined approach unless, as was the case for IPCT, the worst-case screening assessment indicates that the risk is less than 1 in 1 million. One commenter stated that in evaluating the residual risk for IPCT, EPA correctly used the same approach used for the 1989 Benzene NESHAP (40 CFR part 61, subpart Y).

Response: We acknowledge the commenters' support of our general approach to risk assessment and agree that, had risks from the IPCT exceeded the statutory trigger of 1 in 1 million cancer risk or exceeded a similar level of protection for threshold effects, we would have conducted a more refined assessment.

Comment: Three commenters stated that, when presenting the results of the initial screening assessment, it is important for EPA to explain the conservative nature of the assumptions and the limitations of this approach to avoid any misperceptions by the public. Two of the commenters added that otherwise, the public may mistakenly believe that the contribution to risk from major stationary sources is much greater. The commenters also encouraged EPA to use the most accurate emission data and models to ensure accurate risk assessments and to avoid mischaracterizing the risk from the regulated sources. One commenter added that site-specific data should be used in residual risk assessments when possible.

Response: We agree that our risk assessment for IPCT contains a number of health-protective assumptions resulting in a screening assessment that is designed to overestimate, rather than underestimate, risks. However, the health-protective assumptions incorporated into this screening risk assessment are appropriate because we are generalizing the results from a single model facility to all cooling towers in the source category. We designed this approach to ensure that the model facility presents at least as much risk as the worst-case actual facility. Then, by demonstrating that risks from our worst-case model facility are low, we can easily conclude that risks from IPCT at any actual facility will also be low.

The details of our risk assessment can be found in the memorandum titled, “Residual Risk Assessment for the Industrial Process Cooling Towers Source Category,” which is available in the docket. As indicated above, a number of health-protective assumptions are incorporated into the assessment. For example, we based the configuration of our model facility on one of the largest and highest-emitting actual facilities in the IPCT source category. We estimated worst-case emission rates for this facility by assuming that it emitted methanol, ethylene thiourea, and chloroform from its cooling towers even though it is unlikely that any actual towers would emit more than one of these HAP. We assumed that individuals are exposed to IPCT emissions for 24 hours per day and 365 days per year for 70 years although the activity patterns of actual individuals would decrease exposure. Finally, we assumed that people lived at locations very close to the cooling towers. Often, these locations would actually be within the facility's fenceline, where no one actually resides. This combination of health-protective assumptions is appropriate for the IPCT assessment because it allows us to generalize the low-risk finding from a single model source to all sources in the category. If we had not been able to use this approach to make the low-risk finding, we would indeed have collected more refined, site-specific data to develop a more precise risk assessment, but, in this situation, that step was not necessary.

Comment: Four commenters agreed with EPA's approach of considering the risk associated with the specific sources regulated by the NESHAP and not considering co-located sources. Two of the commenters noted that the risk attributed to co-located sources will be evaluated when the appropriate source category is reviewed under section 112(f) of the CAA. The commenters stated that section 112(f) clearly indicates that Congress intended the residual risk assessment for a specific source category to focus on the source category, as defined in the rulemaking under section 112(d), and not to encompass other source categories.

Response: We agree with commenters that the risks attributable to sources collocated with IPCT will be evaluated when the appropriate category is reviewed under section 112(f). We do not agree that our section 112(f) residual risk analyses must always focus only on the source category as defined in the rulemaking under section 112(d) or that Congress intended to limit all residual risk analyses to the individual source categories in question. As we stated in the preamble to the Coke Ovens residual risk rule (70 FR 19998, April 15, 2005), “EPA disagrees that section 112(f) precludes EPA from considering emissions other than those from the source category or subcategory entirely.” Rather, we have concluded that, when the statutory risk trigger is exceeded, the two-step approach set forth in the preamble to the Benzene NESHAP (54 FR 38044, September 14, 1989) remains the approach that we should follow in determinations under section 112(f). At the first step, when determining “acceptable risk,” we will consider risks that result from emissions from the source category only. However, during the second step, we must determine whether additional reductions should be required to protect public health with “an ample margin of safety.” EPA believes that one of the “other relevant factors” that may be considered in this second step is co-location of other emission sources that augment the identified risks from the source category. In the case of coke ovens, this included the consideration of co-located source categories that are integral parts of the same industrial activity. Additional information regarding co-located sources and 112(f) requirements is provided in the preamble to the coke oven residual risk rule (70 FR 19996).

Comment: Three commenters responded to our request for comment on the approach to evaluating residual risk when no pre-existing NESHAP requirement exists for the HAP emissions. For example, in the case of IPCT, the residual risk assessment considered three HAP that were not regulated under the NESHAP. The commenters agreed with EPA's approach, stating that it is appropriate to evaluate and control emissions of other HAP if those HAP pose an unacceptable level of risk.

Response: We acknowledge the commenters' support of our approach to evaluating residual risk by considering all HAP emitted by the regulated source category. Section 112(f) requires EPA to determine if an ample margin of safety has been provided for the source category and as part of that determination we identified other HAP that are emitted from the source category.

Comment: Five commenters responded to our request for comment on the possibility of subcategorizing source categories for the purpose of satisfying the residual risk requirements specified in section 112(f)(2) of the CAA. All five commenters supported the concept of subcategorizing source categories characterized by a broad range of risk levels. Four of the commenters noted that section 112(c) gives EPA broad discretion in creating and modifying categories and subcategories of sources. By subcategorizing, EPA can distinguish between lower risk subcategories and those categories for which additional control is warranted. One of the commenters pointed out that emission characteristics, which vary by subcategory, define the risk of adverse health and environmental impacts. Therefore, establishing separate subcategories on the basis of risk would be consistent with, and would best achieve, the overall statutory mandate of section 112 of the CAA. The same commenter stated that Congress provided a mechanism and criteria for subcategorizing with respect to risk in sections 112(c)(9)(B)(i) and (ii) to preclude overregulating sources that can meet consistent low-risk criteria. Four of the commenters believed that subcategorizing with respect to residual risk would encourage sources to develop site-specific approaches for reducing risk in order to avoid additional regulatory control, work practices, and associated permitting costs. One commenter stated that the intent of Congress was that EPA should focus MACT standards and residual risk requirements on those sources that present a risk of concern. Two of the commenters cited the “Residual Risk Report to Congress” (EPA-453/R-99-001), which supports the concept of regulating only those sources within a source category associated with unacceptable risk. Three of the commenters commented that sources within a lower risk subcategory would still be subject to the NESHAP and would have to continue complying with the standard in order to maintain its low-risk status. The commenters further explained that, even if EPA decides not to subcategorize based on risk, residual risk standards should focus only on the subset of sources that poses unacceptable risk.

Response: We acknowledge the commenters' support for subcategorizing based on risk in order to satisfy section 112(f)(2) of the CAA. For the IPCT source category, our risk assessment indicated that all sources in the category are low-risk. Therefore, there is no need, in the present case, to subcategorize based on risk or any other criteria.

Comment: One commenter commented on our conclusion that emissions of chlorine from IPCT are unlikely under normal operating conditions. We based this conclusion on discussions with water treatment chemical suppliers and information presented in several technical publications on water treatment, all of which clearly stated that chlorine emissions occur only under acidic conditions (i.e., pH of 3.0 or less), and IPCT water treatment programs are designed to maintain alkaline conditions (i.e., pH of 7.5 to 9.0) in the cooling water. The commenter stated that IPCT that are treated with chlorine gas (Cl2) experience significant flash-off of molecular chlorine. He noted that one facility estimated that chlorine emissions from flash-off amounted to 18 percent of the chlorine gas used to treat the cooling water in an IPCT, and that annual emissions of chlorine from the IPCT were estimated to be 18.2 tons. The commenter did not provide documentation for that estimate. However, he did cite a report prepared by the University of Texas for the Texas Natural Resource Conservation Commission (TNRCC), “Emission Inventory for Atomic Chlorine Precursors in Southeast Texas,” which supports his comments regarding chlorine emissions due to flash-off from IPCT. The TNRCC Report also states that the greater the pH, the greater the flash-off rate, which may appear to contradict our conclusion regarding the relationship between pH and Cl2 emissions from IPCT.

Response: As noted above, the commenter did not provide documentation for the estimate of 18.2 tpy of chlorine emissions from a single IPCT. We assume that the basis for that estimate was the TNRCC Report. We reviewed the TNRCC Report, as well as the primary references used as the basis for the chlorine emission estimates presented in the report. Based on our review, we maintain our conclusion that emissions of Cl2 from IPCT are not likely to occur under normal operating conditions.

With respect to the discrepancy between our conclusions regarding emissions of chlorine from IPCT, the statement by the commenter, and the information presented in the TNRC Report, there are two issues that must be resolved: (1) Which chlorine species are emitted from IPCT, and (2) what is the relationship between those emissions and the pH of the cooling water.

When gaseous chlorine is added to cooling water, it dissociates to form hypochlorous acid (HClO), hydrogen (H+), and chloride (Cl−) ions. The HClO further dissociates to form hypochlorite (ClO−) and H+ ions. With respect to the chlorine species emitted, the TNRCC Report presents estimates assuming that chlorine emissions are entirely in the form of Cl2. The Report does not provide the basis for this assumption, but does note that “* * * chlorine may be released as HClO, Cl2, or in other chemical forms * * *” The Report later states that emissions “* * * may be in the form of HOCl rather than Cl2.” Apparently, because the focus of the TNRCC Report was the magnitude of the emissions rather than the form of the chlorine emitted, the researchers did not attempt to determine which chlorine species would be emitted. The primary references cited in the TNRCC Report regarding chlorine emissions from IPCT are two journal articles from 1984 by Holzwarth, et al. The introduction to the first of those articles explains that chlorine gas added to cooling water “* * * immediately reacts with water to form HOCl and HCl.” All of the subsequent discussion and calculations in both papers regarding flash-off are in terms of HOCl and other non-Cl2 chlorine compounds. In fact, Cl2 is not mentioned again in either article. In other words, the Holzwarth articles support our conclusion that chlorine is not emitted from IPCT in the form of Cl2.

With respect to the relationship between pH and emissions of chlorine species, we do not argue that emissions from flash-off may increase with increasing pH. However, our assessment concluded that these emissions would be entirely in the form of HOCl and not as Cl2. The studies by Holzwarth, et al. also support this conclusion, that emissions of HOCl increase with increasing pH, while emissions of Cl2 decrease with increasing pH.

In summary, we believe our conclusions regarding emissions of Cl2 from IPCT are correct. Neither the commenter, nor the references cited by the commenter provide any basis for concluding otherwise.

Comment: Six commenters responded to our request for comment on the issue of delisting the IPCT source category in light of the results of the residual risk assessment. Two of the commenters opposed delisting the source category; one of the commenters supported delisting; and the other commenters, although not opposed to delisting, found no compelling reason to do so. One of the commenters who opposed delisting stated that delisting the source category would not be appropriate because such action would allow owners and operators of IPCT to revert back to using chromium water treatment chemicals. The commenter also noted that delisting the source category would require State and local agencies to amend their rules accordingly. Because there would not be a NESHAP to adopt by reference, State and local agencies would be required to develop and adopt their own regulations on IPCT. In addition, the commenter pointed out that some regulatory agencies are prevented from adopting rules that are more stringent than Federal requirements. In those cases, States and local agencies would have no legal means of preventing IPCT owners and operators from resuming the use of chromium water treatment chemicals in IPCT.

The other commenter who opposed delisting stated that, if the source category were delisted, there would be nothing to prevent sources from increasing their HAP emissions substantially or changing their processes to emit new HAP, either of which could result in HAP levels that are unacceptable to public health and the environment. He noted that such action would disregard the possibility that HAP emissions have been reduced to an acceptable level because of the NESHAP.

Three of the commenters were not opposed to delisting the IPCT source category, but remarked that there was no compelling reason to do so. The commenters noted that, even though the IPCT NESHAP does not apply to any existing sources, it is possible for the rule to apply to sources in the future. The commenters gave the example of an area source, which operated an IPCT using chromium water treatment chemicals and later became a major source. Once the facility became a major source, it would be subject to the NESHAP and would have to discontinue the use of chromium water treatment chemicals. The commenters stated that, on the other hand, delisting a source category does not affect the applicability of an existing NESHAP. The commenters explained that the applicability of the Asbestos NESHAP (40 CFR part 61, subpart M) was unchanged after the source category was delisted. Finally, the commenters pointed out that none of the applicability requirements of 40 CFR part 63 standards (i.e., NESHAP) depend on source category listing.

One of the commenters supported delisting the IPCT source category. The commenter stated that our request for comment on this issue implied that we interpreted section 112(c)(9) of the CAA to apply only before a MACT standard has been promulgated. According to the commenter, section 112(c)(9) grants EPA the authority to delist a source category whenever the Administrator determines that the risks meet the established criteria. The commenter noted that delisting source categories based on risk prior to establishing standards under section 112(d) actually would conflict with the sequence of EPA's duties under section 112, which requires EPA to evaluate residual risk 8 years after promulgation. In addition, the commenter pointed out that EPA would likely not have sufficient data to fully assess the risk until several years after a standard had been in place. Finally, if EPA were to delist the source category, section 112(c)(9) could still be used to establish requirements to ensure that the risk remains within acceptable levels if EPA were to conclude that the risk associated with the source category could become unacceptable in the future.

Response: Based on our risk assessment of the IPCT source category, we have concluded that these sources are low-risk and, therefore, that no further standards are required to protect public health with an ample margin of safety or to protect the environment. However, we agree with the commenter who argues that this conclusion is based, at least in part, on the fact that the MACT requirements for these sources prevent IPCT from using chromium-based water treatment strategies. Further, we disagree with the comment that delisting would not affect the existing NESHAP. The commenter cited the delisting action following the Asbestos NESHAP as support for their argument, noting that the applicability of that rule was not affected by delisting. However, the Asbestos NESHAP was established under 40 CFR part 61, which is not directly relevant in this situation since the IPCT NESHAP is a 40 CFR part 63 rule. If we delist this source category, it is our opinion that existing facilities with IPCT would no longer be subject to the NESHAP and would not be banned from using chromium. If any sources reverted to using chromium, risks could increase, and the basis for our finding that the source category is low-risk would be compromised. Thus, since compliance with the MACT standard is part of the basis for our low-risk determination, we believe our policy objectives are best served if we do not delist the IPCT source category. However, as long as the NESHAP exists and prohibits the use of chromium-based water treatment chemicals, we agree with the commenters who suggest that IPCT sources no longer using these chemicals should not be subject to this NESHAP. Therefore, we are amending the applicability section of the rule to clarify that sources no longer using chromium-based water treatment chemicals are not subject to this NESHAP. The NESHAP remains in effect, and any source that uses chromium-based water treatment chemicals will be subject to the rule and in violation.

Contrary to one commenter's contention, we do not interpret section 112(c)(9) of the CAA to apply only before a MACT standard has been promulgated, although that is expected to be the situation in which it is most likely exercised. We agree that section 112(c)(9) grants EPA the authority to delist a source category when the Administrator determines that risks meet the established criteria, including after promulgation of a MACT standard.

The Agency would like to remove the burden of the repetitive review of Section 112 standards for low risk source categories. At the same time, we think it is appropriate to maintain the MACT controls in this case. We plan to further investigate approaches for removing low-risk source categories from the Section 112 universe while maintaining MACT-level controls. An example of a similar approach is found in the Plywood and Composite Wood Products MACT where we allow a subcategory of facilities to reduce emissions to acceptable risk levels through Title 5 permits and remove them from the MACT universe.

Comment: One commenter remarked that EPA should not have conducted an initial technology review of the IPCT source category. The commenter explained that once a residual risk determination indicates the risk is acceptable, EPA must find that revising the standard under CAA section 112(d)(6) is not necessary. The commenter stated that the legislative history of the CAA demonstrates that Congress rejected imposing controls beyond levels considered to be safe and protective of public health because those controls would impose regulatory costs without any public health benefit. The commenter stated that, if Congress had intended EPA to conduct technology reviews regardless of the outcome of the residual risk assessment, there would be no need for CAA section 112(f). The commenter believes that technology reviews under section 112(d)(6) were meant to be regulatory backstop authority for residual risk reviews, similar to the MACT hammer provision in section 112(j) of the CAA. That is, if EPA failed to address the residual risk for a source category, section 112(d)(6) authority could be used to ensure that advances in technology could still be applied to the source category.

Response: We disagree with the comment that we should not have conducted an initial technology review under CAA section 112(d)(6) for the IPCT source category. The timing requirements for the initial analysis under section 112(d)(6) coincide with those for the residual risk analysis. Thus, it is appropriate for us to conduct both analyses at the same time. Although the results of the risk analysis may impact future section 112(d)(6) technology reviews, these results do not negate the need to perform the initial review. Additional information regarding the relationship between residual risk standards and 112(d)(6) review requirements is provided in the preamble to the Coke Oven residual risk rule (70 FR 20008, April 15, 2005).

Comment: Seven commenters responded to our request for comment on continuing technology reviews every 8 years for source categories subject to NESHAP, as required by section 112(d)(6) of the CAA. Four commenters stated that EPA should not use a “bright line approach” in determining the need for technology reviews under section 112(d)(6) of the CAA. For example, the decision of whether or not to perform a technology review should not be based on a 1-in-1-million risk level, as is the case for residual risk. One of those commenters stated that discontinuing technology reviews would be contrary to the requirements of the CAA. The commenter noted that the phrase “* * * every 8 years” implies a continuum rather than a single action, and if Congress had intended the technology review to be a one-time requirement, it would have used other language in the CAA. As an example of a one-time requirement, the commenter cited CAA section 112(n)(1), which states that “The Administrator shall conduct, and transmit to Congress not later than 4 years after the date of enactment * * *” The other commenter who opposed discontinuing technology reviews remarked that, without future reviews, it is unlikely that EPA would know what new technologies have been developed or know of any unforeseeable circumstances that might substantially change the source category or its emissions.

Three of the commenters stated that, by implementing residual risk requirements under section 112(f) or determining that residual risk requirements are not warranted, EPA completes its obligation to conduct technology reviews under section 112(d)(6) of the CAA. Thus, once the residual risk has been evaluated and the appropriate action taken, technology reviews are no longer required. However, the commenters also stated that later technology reviews may be appropriate if the ample margin of safety established by the residual risk process is based largely on cost or technical feasibility, and feasible, cost-effective controls are identified in the future. Four of the commenters stated that technology reviews under section 112(d)(6) should not provide for a continuing technology ratchet based on the availability of new technology. Instead, technology reviews should be conducted in the context of providing an ample margin of safety under section 112(f) of the CAA.

Response: We agree that a technology review is required every 8 years for emission standards under 112(d) or if new standards are issued pursuant to 112(f). However, if the ample margin of safety analysis for a section 112(f) standard shows that remaining risk for non-threshold pollutants falls below 1 in 1 million and for threshold pollutants falls below a similar threshold of safety, then further revision would not be needed because an ample margin of safety has already been assured. Additional information regarding the relationship between residual risk standards and 112(d)(6) review requirements is provided in the preamble to the Coke Oven residual risk rule (70 FR 20008, April 15, 2005).

Comment: Four commenters commented that technology reviews under section 112(d)(6) should be limited to emission standards already established under section 112(d). Three of the commenters stated that, although it is appropriate to evaluate and control emissions of other HAP not regulated by the NESHAP under section 112(f), such HAP should not be considered under the section 112(d)(6) technology review.

Response: The emission standards imposed a prohibition on the use of chromium-based water treatment chemicals in IPCT. Since the risk from other HAP emitted from IPCT due to the addition of water treatment chemicals was determined to be very low and the emission standards already preclude the use of chromium-based water treatment chemicals, we concluded that no further controls are necessary under either 112(f) or 112(d)(6). As stated previously, section 112(d)(6) requires that the emission standard be reviewed and revised as necessary no less often than every 8 years. Additional information regarding the relationship between residual risk standards and 112(d)(6) review requirements is provided in the preamble to the residual risk for coke ovens (70 FR 20008, April 15, 2005).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA must determine whether a regulatory action is “significant” and, therefore, subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

Pursuant to the terms of Executive Order 12866, OMB has notified EPA that it considers this a “significant regulatory action” within the meaning of the Executive Order. EPA has submitted this action to OMB for review. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

The final rule amendment does not impose any information collection burden. It will not change the burden estimates from those previously developed and approved for the existing NESHAP. OMB has previously approved the information collection requirements contained in the existing regulation (40 CFR part 63, subpart Q) under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501, et seq. (OMB control number 2060-0268). However, this information collection request has been discontinued because the information requested in the original regulation is no longer needed.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR part 63 are listed in 40 CFR part 9.

EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with this final rule amendment.

For purposes of assessing the impacts of today's final rule amendment on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

After considering the economic impacts of today's final rule amendment on small entities, EPA has concluded that this final action will not have a significant economic impact on a substantial number of small entities. The final rule amendment does not impose any requirements on small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

The EPA has determined that the final rule amendment does not contain a Federal mandate (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector because it imposes no enforceable duty on any State, local, or tribal governments or the private sector. Thus, today's final amendment is not subject to the requirements of sections 202 and 205 of the UMRA. In addition, EPA has determined that the final amendment contains no regulatory requirements that might significantly or uniquely affect small governments, because it contains no requirements that apply to such governments or impose obligations upon them.

Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government.”

Today's final amendment does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. Thus, Executive Order 13132 does not apply to the final amendment.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” The final amendment does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to today's final amendment.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) is determined to be “economically significant” as defined under Executive Order 12866 and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by EPA.

The final amendment is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866 and because EPA does not have reason to believe the environmental health or safety risks addressed by this action present a significant disproportionate risk to children.

The final amendment is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001) because it is not an economically significant regulatory action under Executive Order 12866.

As noted in the proposed rule, section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards (VCS) in its regulatory activities, unless to do so would be inconsistent with applicable law or otherwise impractical. The VCS are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by VCS bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency does not use available and applicable VCS. The final amendment does not involve technical standards. Therefore, EPA is not considering the use of any VCS.

The Congressional Review Act, 5 U.S.C. 801, et seq., as added by the Small Business Regulatory Enforcement Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing the final rule and other required information to the United States Senate, the United States House of Representatives, and the Comptroller General of the United States prior to publication of the final rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register.This action is not a “major rule” as defined by 5 U.S.C. 804(2). The final amendment is effective on April 7, 2006.

Regulated Entities. Categories and entities potentially regulated by this action include:

This list is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. To determine whether your facility is regulated by this action, you should examine the applicability criteria in section 63.8985 of the final rule. If you have questions regarding the applicability of this action to a particular entity, consult your State or local agency (or EPA Regional Office) described in the preceding FOR FURTHER INFORMATION CONTACT section.

Worldwide Web (WWW). In addition to being available in the docket, an electronic copy of today's action is available on the WWW through the Technology Transfer Network (TTN). Following signature, a copy of the final amendments will be posted on the TTN's policy and guidance page for newly proposed or promulgated rules http://www.epa.gov/ttn/oarpg.

Judicial Review. Under section 307(b) of the Clean Air Act (CAA), judicial review of the final rule is available only by filing a petition for review in the U.S. Court of Appeals for the District of Columbia Circuit on or before June 6, 2006. Only those objections to the final rule which were raised with reasonable specificity during the period for public comment may be raised during judicial review. Moreover, under CAA section 307(b)(2), the requirements established by today's final action may not be challenged separately in any civil or criminal proceeding we bring to enforce these requirements.

Section 307(d)(7)(B) of the CAA further provides that “only an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for EPA to convene a proceeding for reconsideration, “if the person raising an objection can demonstrate to EPA that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration to EPA should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, Ariel Rios Building, 1200 Pennsylvania Ave., NW., Washington, DC 20460, with a copy to both the person(s) listed in the FOR FURTHER INFORMATION CONTACT section, and the Director of the Air and Radiation Law Office, Office of General Counsel (Mail Code 2344A), U.S. EPA, 1200 Pennsylvania Ave, NW., Washington, DC 20004.

Outline. The information in this preamble is organized as follows:

Section 112 of the CAA requires EPA to list categories and subcategories of major sources and area sources of hazardous air pollutants (HAP) and to establish NESHAP for the listed source categories and subcategories. Hydrochloric acid production and fume silica production were listed as source categories under the production of inorganic chemicals group on EPA's initial list of major source categories published in the Federal Register on July 16, 1992 (57 FR 31576).1 On September 18, 2001, we combined these two source categories for regulatory purposes under the production of inorganic chemicals group and renamed the source category as HCl production (66 FR 48174). Major sources of HAP are those that have the potential to emit greater than 9.07 megagrams per year (Mg/yr) (10 tons per year (tpy)) of any one HAP or 22.68 Mg/yr (25 tpy) of any combination of HAP.

The final rule was published in the Federal Register on April 17, 2003 (68 FR 19076). The final rule contains emission limitations and standards applicable to HCl and chlorine (Cl2). These limits apply to each new or existing HCl process vent, HCl storage tank, HCl transfer operation, and leaks from equipment in HCl service located at a major source of HAP. Following promulgation of the final rule, EPA became aware of certain aspects of the applicability provisions, emission standards, and testing, maintenance, and reporting requirements that required clarification along with several omissions and typographical errors in the final rule that required correction. On August 24, 2005, we published proposed amendments (70 FR 49530) to address these issues and sought public comment on the proposed amendments. Today's action finalizes those clarifications and corrections. The preamble to the proposed amendments discussed the availability of technical support documents, which described in detail the information gathered during the standards development process.

We received four public comment letters on the proposed amendments. The commenters represent HCl producers and industrial trade associations. All of the comments have been carefully considered, and, where appropriate, changes have been made for the amendments to the final rule.

We are finalizing amendments to 40 CFR part 63, subpart NNNNN, to change the applicability provisions, to clarify testing, monitoring, and reporting requirements, and to correct inadvertent omissions and typographical errors. A summary of each of the amendments to 40 CFR part 63, subpart NNNNN, and the rationale for each is presented below.

In order to avoid regulatory overlap, the HCl Production NESHAP exempt certain HCl production facilities that are part of other source categories and subject to other Federal standards. We intended the HCl Production NESHAP to cover only those HCl production facilities that were not subject to any other NESHAP and not to cover those HCl production facilities that were subject to other NESHAP. Today's final amendments adjust the applicability provisions to rectify three situations that came to our attention after promulgation of the HCl Production NESHAP in which this intent was not satisfied.

First, the final amendments will address the HCl Production NESHAP's exemptions for HCl production facilities that are subject to certain other regulations, including 40 CFR part 63, subpart EEE (the Hazardous Waste Combustors NESHAP), and 40 CFR 266.107, subpart H (regulations issued under the Resource Conservation and Recovery Act governing the Burning of Hazardous Wastes in Boilers and Industrial Furnaces). As worded in the final rule, the exemptions were overly broad, because neither of the above final rules covers emissions of HCl from HCl storage tanks, HCl transfer operations, or leaks from equipment in HCl service at these facilities. This leaves these emission points not subject to any Federal standards, which was not our intent. Therefore, we are amending subpart NNNNN of 40 CFR part 63 to exempt facilities that are subject to subpart EEE of 40 CFR part 63 or subpart H of 40 CFR part 266 and that meet the applicability requirements of subpart NNNNN from only the HCl process vent provisions of subpart NNNNN, rather than from all of the requirements of subpart NNNNN. Because the purpose of 40 CFR 63.8985(b) and (c) is to provide exemptions from all of the requirements of subpart NNNNN for entire HCl production facilities subject to certain other rules, we are removing 40 CFR 63.8985(b)(4) and (c)(3) to eliminate the overly broad exemptions and instead are adding new paragraphs to 40 CFR 63.9000(c) to accomplish the exemptions. The purpose of 40 CFR 63.9000(c) is to exempt certain emission streams from subpart NNNNN. Under 40 CFR 63.9000(c), plants that are subject to subpart EEE of 40 CFR part 63 or subpart H of 40 CFR part 266 and that meet the other applicability provisions of subpart NNNNN would be affected sources under subpart NNNNN but would be exempt from the process vents provisions of subpart NNNNN.

Second, the amendments revise the HCl Production NESHAP's exemptions for specific emission streams to eliminate duplicative regulation. Some emission points that are not themselves subject to subpart EEE of 40 CFR part 63 have their emissions controlled under subpart EEE because their emissions are routed directly through equipment that is subject to subpart EEE (e.g., an HCl process vent emission stream routed to a hazardous waste combustor (HWC) for use as supplemental combustion air). Currently, these emissions (e.g., from the combustor) are regulated by both subpart EEE and subpart NNNNN of 40 CFR part 63. To rectify this situation, we are adding a new paragraph to 40 CFR 63.9000(c) to include an emission stream-specific exemption for HCl process vents, HCl storage tanks, and HCl transfer operations that are routed directly to HWC units subject to subpart EEE. This means that HCl production facility emission streams that are routed to subpart EEE HWC units are exempt from the requirements of subpart NNNNN.

Finally, the amendments remove the HCl Production NESHAP's exemption for HCl production facilities subject to 40 CFR 264.343(b), subpart O (Incinerators), which will no longer be necessary. A combustor that burns hazardous waste and meets the subpart NNNNN of 40 CFR part 63 definition of an HCl production facility would be defined as a halogen acid furnace (currently subject to 40 CFR 266.107, subpart H, and that will be subject to 40 CFR part 63, subpart EEE, on the compliance date (October 14, 2008) of EPA's final rule promulgated on October 12, 2005 (70 FR 59402)), not an incinerator (subject to 40 CFR 264.343(b), subpart O). As discussed above, we are amending the applicability provisions of the HCl Production NESHAP to properly address HCl production facilities that are subject to 40 CFR part 266, subpart H. Therefore, the exemption for 40 CFR part 264, subpart O, is no longer necessary, and we are removing 40 CFR 63.8985(c)(2), which provided this exemption. Consequently, we are incorporating the exemption provided in 40 CFR 63.8985(c)(1) into 40 CFR 63.8985(c), and, thus, removing 40 CFR 63.8985(c)(1).

We are clarifying the meaning of “equipment in HCl service,” which is defined in the HCl Production NESHAP as “each pump, compressor, agitator, pressure relief device, sampling connection system, open-ended valve or line, valve, connector, and instrumentation system that contains 30 weight percent or greater of liquid HCl or 5 weight percent or greater of gaseous HCl at any time” (40 CFR 63.9075). This definition could be interpreted to include equipment that is located at the same plant site as an “HCl production facility” (40 CFR 63.8985(a)(1)) but is not part of the HCl production facility. We intended to include only equipment that meets the above definition and is located within an HCl production facility. Therefore, we are amending the definition of “equipment in HCl service” in 40 CFR 63.9075 to clarify that the definition applies only to equipment within an HCl production facility.

The HCl Production NESHAP specify the emission limits for existing and new HCl process vents, HCl storage tanks, and HCl transfer operations in two forms—a percent reduction and an outlet concentration—and allows HCl production facilities to comply with either one. However, the wording of the emission limits could be construed to require the use of an add-on control device even when an emission point meets the outlet concentration emission limit without an add-on control device. It was not our intent to require add-on control devices when they are unnecessary for compliance. Although a percent reduction emission limit would need to be achieved through the use of an add-on control device, we recognize that an outlet concentration emission limit could be achieved through other means (e.g., process changes, pollution prevention). Therefore, we are amending table 1 to subpart NNNNN of 40 CFR part 63 to clarify that it is not necessary to use an add-on control device in order to meet the outlet concentration form of the emission limits. In addition, we are amending tables 3 and 5 to subpart NNNNN to specify the sampling port location and continuous compliance requirements, respectively, for sources that are not equipped with an add-on control device. Also, we are amending 40 CFR 63.9015(a) to require that emission points meeting the outlet concentration limits without the use of a control device conduct subsequent performance tests when process changes are made that could reasonably be expected to change the outlet concentration. Finally, we are amending 40 CFR 63.9050 by adding paragraph (c)(9), which specifies that compliance reports must include verification that no process changes that could reasonably be expected to change the outlet concentration have been made since the last performance test.

The HCl Production NESHAP are silent on the issue of how maintenance is to be conducted on HCl storage tank control devices. This could lead to uncertainty over whether an HCl storage tank would need to be emptied before the associated control device could be disconnected for maintenance purposes. It was not our intent that an HCl storage tank would need to be emptied prior to maintenance because the standing losses associated with a full or partially-full HCl storage tank are low, when compared to the emissions that occur from filling and emptying the tank. To clarify our intent, we are amending 40 CFR 63.9000, by adding paragraph (d), to allow HCl production facilities to perform planned routine maintenance on each HCl storage tank control device for up to 240 hours per year without emptying the contents of the tank. During this time, the storage tank emission limitations would not apply. Also, we are amending 40 CFR 63.9050, by adding paragraph (c)(10), and 40 CFR 63.9055, by adding paragraph (b)(6), to specify the reporting and recordkeeping requirements for planned routine maintenance events. These provisions are consistent with other NESHAP to which plant sites containing HCl production facilities may be subject.

The HCl Production NESHAP require the submission of a Notification of Compliance Status (NOCS) to the Administrator when a performance test is conducted (40 CFR 63.9045(a), table 7 to subpart NNNNN of 40 CFR part 63, and 40 CFR 63.9(h)). It could be interpreted that 40 CFR 63.9045(e) and (f) require the submission of a separate NOCS for each performance test that is conducted (e.g., on each emission point). It is more efficient and no less effective for HCl production facilities to submit one NOCS for the entire affected source, rather than one NOCS for each emission point tested, and it was not our intent to require unnecessary paperwork. Therefore, we are amending 40 CFR 63.9045 to change the submission procedures for NOCS. We will allow NOCS to be submitted within 240 calendar days of the compliance dates for subpart NNNNN of 40 CFR part 63. The final amendments allow for the submission of only one NOCS per affected source because the notification is due 60 days after all performance tests are required to be conducted. We are also amending table 7 to subpart NNNNN to reflect this change to the NOCS submission procedures.

The HCl Production NESHAP require submission of the initial site-specific monitoring (40 CFR 63.9005(d)) and LDAR (LDAR; table 1 to subpart NNNNN of 40 CFR part 63) plans to the Administrator with a source's NOCS. The final rule does not, however, specify when or how revisions to these plans should be submitted, only that they should be submitted (40 CFR 63.9055(b)(5)). Submission of revisions to these plans is most efficiently done in conjunction with the semi-annual compliance report required by 40 CFR 63.9050. Therefore, we are amending 40 CFR 63.9050(c) by adding paragraph (c)(8) to require submission of revisions to site-specific monitoring plans and LDAR plans with semi-annual compliance reports, if revisions have been made during the reporting period.

We are adding an exemption which was inadvertently omitted from the HCl Production NESHAP. In the preamble to the final rule (68 FR 19082), we indicated that we would include an exemption for HCl production facilities subject to 40 CFR 63.994, subpart SS. Because this exemption was not included in the final rule text, we are amending the rule to include it. Because we are removing 40 CFR 63.8985(b)(4), we are replacing it with the exemption for 40 CFR 63.994, subpart SS.

We are removing the phrase “/Cl2” from 40 CFR 63.8990(b)(4) to reflect a change made between the proposed rule and the final rule which was retained incorrectly in the final rule. The proposed rule used the term “in HCl/Cl2 service,” but we wrote this term as “equipment in HCl service” in the final rule. We are making the same change in the first column of table 1, item 4, to subpart NNNNN of 40 CFR part 63.

We are correcting an inaccurate reference in 40 CFR 63.9025(a) regarding operating parameters. The reference should be to 40 CFR 63.9020(e), which requires operating parameters to be established, rather than to 40 CFR 63.9020(d). This was a typographical error in the final rule.

We are correcting an inaccurate reference in the definition of “HCl production facility” in 40 CFR 63.9075. The reference to 40 CFR 63.8985(a)(i) should be to 40 CFR 63.8985(a)(1) because 40 CFR 63.8985(a)(i) does not exist. This was a typographical error in the final rule.

This section includes discussion of the significant comments received on the proposed amendments, particularly where we made changes to address those comments in the amendments to the final rule. For a complete summary of all the comments received on the proposed rule and our responses to them, refer to the “RESPONSE TO SIGNIFICANT PUBLIC COMMENTS Received in response to Proposed amendments to National Emission Standards for Hazardous Air Pollutants: Hydrochloric Acid Production” in Docket ID No. EPA-HQ-OAR-2002-0057. The docket also contains the actual comment letters and supporting documentation developed for the final amendments.

Comment: One commenter recommends that EPA need not include proposed 40 CFR 63.9000(c)(4) as proposed 40 CFR 63.9000(c)(5) is more inclusive and includes the conditions addressed in 40 CFR 63.9000(c)(4).

Response: EPA agrees with the concept put forward by the commenter and has reworded paragraph (c)(4) to encompass the language proposed in paragraphs (c)(4), (c)(5), and (c)(6).

Comment: Two commenters request that EPA clarify the change provisions in proposed 40 CFR 63.9015(a) to explain that the provisions to retest process vent emissions should be tied to a change that could cause an increase in emissions rather than, as currently worded, “whenever process changes are made that could reasonably be expected to change the outlet concentration.” A similar change was requested to the language in 40 CFR 63.9050(c)(9).

Response: EPA agrees with the commenters and has made the suggested changes. This language is consistent with other rulemaking actions.

Comment: One commenter requests that EPA define “temporary process changes,” in proposed 40 CFR 63.9015(a) to be changes of less than 1 year in duration where the owner/operator believes that the source will continue to demonstrate compliance without changing the compliance demonstration method.

Response: EPA disagrees with the commenter. As mentioned in the previous response, without emissions test data, no one can determine the effect of a change—temporary or not—on an existing facility. Moreover, the commenter errs by excluding the term “unintentional” in discussing “temporary process changes.” As written, the final rule identifies “unintentional, temporary process changes” (emphasis added) as not being process changes. Surely a process change lasting up to 1 year could not be considered unintentional. Absent any information as to the length of time “unintentional temporary” process changes should or could last, we have not revised the final rule.

Comment: One commenter believes that the requirement to measure the pH of the scrubber water as provided in 40 CFR 63.9020(e)(1) and Table 5 to subpart NNNNN is an inappropriate operational parameter and should be removed from the final rule. The commenter believes that monitoring the water flow of the scrubber is a sufficient measurement of scrubber performance, as seen during performance testing. The Pesticide Active Ingredient Production NESHAP (40 CFR 63.1366(b)(ii)) allows for either minimum liquid flow rate or pressure drop to be chosen as operating parameters during the period in which the scrubber is controlling HAP from an emission stream and only requires the measurement of pH if a caustic scrubber is being used. The commenter believes that a rule change is more efficient than going through the alternative monitoring request process.

Response: EPA disagrees with the commenter's suggestion to replace monitoring of the scrubber water effluent pH with monitoring of the minimum liquid flow rate or pressure drop only. Apart from directly measuring HCl emissions, monitoring of the outlet pH of the scrubber water, as well as the water flow rate into the scrubber, provides the most complete depiction of parametric monitoring and best measure for process control. Parametric monitoring that provides a less certain depiction, and corresponding level of process control, would include scrubber water outlet pH monitoring and flow monitoring. The least-certain depiction, and corresponding level of process control, would arise from monitoring only the scrubber water flow. Although such least-certain monitoring may be appropriate under certain circumstances, sources subject to the HCl production NESHAP may rely on techniques other than once-through scrubber water use. In order not to prescribe any control technique, source owners or operators are able to choose an approach that works best for them. The Pesticide NESHAP cited by the commenter differs from the HCl NESHAP and what is applicable for sources subject to the Pesticide NESHAP may not be relevant for sources subject to the HCl Production NESHAP. Further, the commenter fails to note that other standards that regulate HCl emissions require the monitoring of effluent pH. A more comparable example is that of 40 CFR part 63, subpart EEE, National Emission Standards for Hazardous Air Pollutants for Hazardous Waste Combustors. In this NESHAP, where the HCl production process is very similar to that of the HCl Production NESHAP, monitoring of effluent pH is required whenever a wet scrubber, water or caustic, is used (40 CFR 63.1209(o)(3)(iv)).

EPA is unaware of any difficulty faced by source owners or operators subject to the HCl Production NESHAP in getting approval for alternative monitoring as suggested by the commenter. In fact, at least two HCl Production NESHAP source owners/operators have demonstrated a need for an alternative monitoring technique, requested approval for such technique, and received approval for that technique by the Regional offices.

Comment: Two commenters request that the provision allowing the use of engineering evaluations in lieu of emission testing, as proposed in 40 CFR 9020(e)(3), be amended to include process vents as well as the currently proposed allowance for storage tanks and transfer operations. The commenters note that EPA has historically allowed such assessments for process vents in other NESHAP (e.g., 40 CFR 63.1258(b)(3)(i); 40 CFR 63.1365(c)(3)(i)(A); 40 CFR 63.1426(f)) and continues to support the use of design evaluations (40 CFR 63.2450(h)).

Response: EPA disagrees with the commenters' suggestion. The standards cited by the commenters all deal primarily with organic HAP, with HCl occurring in more limited quantities, as opposed to the primacy of HCl emissions encountered in the HCl Production NESHAP. The commenters provide no data to support their contention about use of engineering evaluations in lieu of emissions testing for HCl and Cl2 for the process vents. Design values as supplied by such engineering evaluations may be appropriate for small emitters (i.e., those below the NESHAP applicability level) as was done for at least some of the cited NESHAP, but substantial, uncontrolled emissions “ such as those that could come from process vents—should be measured.

Again, EPA feels that a more comparable example is the Hazardous Waste Combustor NESHAP (40 CFR part 63, subpart EEE). In this standard (40 CFR 63.1207(m)), conservative engineering evaluations are allowed in lieu of emissions testing for sources that can comply with the emission standards assuming all chlorine in the feed is emitted as total chlorine (HCl + Cl2)—if the maximum theoretical emission concentration does not (cannot) exceed the emission standards, emissions testing is waived. However, HCl production furnaces could not comply with this waiver of the emission test because they rely on wet scrubbers/absorbers to produce HCl product and control emissions of HCl/Cl2. We believe this situation is analogous to that encountered in the HCl Production NESHAP where we have allowed engineering evaluations to be utilized for those emission sources that could possibly emit below the emission standard (i.e., the storage tanks and transfer operations) but have required emission testing for the emission sources that are not likely to emit below the standard without the use of a control device (i.e., the process vents).

Comment: Two commenters request that EPA clarify the deadline for compliance with the final rule and the dates when the initial reports are due in 40 CFR 63.9050(b)(1) and (2), believing that there could be confusion among the various entities affected by the rule concerning the submittal date for the first compliance report. They suggest that the rule language specifically state that January 31, 2007, is the date on which the first compliance report is due.

Response: EPA agrees that the wording could be confusing and has added clarification to the language of the regulation to indicate that, for sources in existence on April 17, 2006, the initial compliance period ends June 30, 2006, and the initial compliance report is due on July 31, 2006.

Comment: Two commenters expressed concern about the planned maintenance advance notification requirements in proposed 40 CFR 63.9050(c)(10)(ii) in that planned maintenance schedules are subject to change with little or no notice. One of the commenters believes that a facility could, in good faith, report advance plans of maintenance to the permit authority and EPA but then, due to an unforeseen change of plans, not conduct the planned maintenance on the proposed schedule or identify additional, required work that was not in the maintenance plan. The commenter believes that EPA should not establish a regulation where a decision is required to respond to plant-specific conditions that have no impact on emissions becomes a regulatory enforcement matter. The commenter believes that EPA already has sufficient authority through the existing startup, malfunction, and shutdown (SSM) provisions to review such maintenance activities without requiring the additional reporting required by 40 CFR 63.9050(c)(10)(ii). The other commenter requests that tracking of compliance with any needed notification requirements only be included in the required periodic reports (as proposed in 40 CFR 63.9050(c)(10)(i)) or that such reporting not be required unless a deviation of a monitoring condition or an exceedances of an emission limit occurs during the periodic reporting period. One commenter believes that the proposed requirement is overly burdensome and unnecessary. Further, the commenter states that it is not aware of any other NESHAP that requires advance reporting of anticipated planned routine maintenance activities on emission control devices.

Response: EPA disagrees with the commenters. In adding this requirement, EPA was responding to concerns that the rule language was unclear on whether an HCl storage tank would need to be emptied before the associated control device could be disconnected for maintenance purposes. In the proposed amendments to the final rule, EPA provided language that allowed owners/operators to perform maintenance on each HCl storage tank for up to 240 hours per year without emptying the storage tank. During this period, the storage tank emissions would not apply. The notification requirement was included to ensure that the recipient of the periodic reports is aware of planned maintenance activities related to the HCl storage tanks, including the type of maintenance to be performed and the duration of the maintenance (which would be the length of time during which the emission standards would not apply). Further, EPA does not believe that an out-of-compliance period should suddenly become a “maintenance period.” EPA does not see the dilemma the commenters believe themselves subject to. If a planned maintenance period does not occur, EPA sees no harm or liability for having reported it. EPA recognizes that planned maintenance activities may, on occasion, not occur as scheduled. In cases where an owner/operator had included planned maintenance in a periodic report but the maintenance did not occur, EPA would expect that the owner/operator would merely explain the situation in the next periodic report. EPA understands that occasionally additional unplanned maintenance needs are discovered in the course of a planned maintenance and believes that the regulations are sufficiently flexible to accommodate such circumstances. EPA believes that 240 hours is sufficient time to effect maintenance on HCl storage tank control devices. However, should planned maintenance on such devices require 240 or greater hours per year, the owner/operator would be required to drain the HCl storage tank or comply with the emission limits without the control device in-place.

Comment: One commenter expressed concern about changes made to item 4 in table 1 to subpart NNNNN where the term “and new” sources was added to the existing language. The commenter believes that this change was not discussed in the preamble to the proposed amendments and that this addition significantly broadens the impact of the rule and should be justified.

Response: Item 4 in table 1 to subpart NNNNN only addressed leaking equipment at existing sources. EPA acknowledges that it was an oversight in the regulatory language in the final rule to omit leaking equipment at new sources and, so as a technical correction, added “and new” to the language of item 4 in the proposed amendments. The text of the final rule preamble related to the emission limitations and work practice standards (68 FR 19079) provides discussion for process vents, storage tanks, and transfer operations at both new and existing sources. However, for leaking equipment, the text only states “[f]or leaking equipment, the final rule includes a work practice standard.” EPA believes that the lack of distinction between leaking equipment at new and existing sources is indication that the final rule applies to both situations. EPA sees no reason to omit new sources from having to address leaking equipment and does not agree with the commenter's concern about this adjustment “significantly” broadening the impact of the final rule.

The changes incorporated as a result of the final rule amendments do not change any of the impacts presented in the preamble to the final rule which was published at 68 FR 19076 (April 17, 2003).

Under EO 12866 (58 FR 51735; October 4, 1993), EPA must determine whether the regulatory action is “significant” and, therefore, subject to review by the Office of Management and Budget (OMB) and the requirements of the EO. The EO defines a “significant regulatory action” as one that is likely to result in a rule that may:

(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlement, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the EO.

It has been determined that today's action is not a “significant regulatory action” under the terms of EO 12866 and is, therefore, not subject to OMB review.

OMB has approved the information collection requirements in the 2003 NESHAP for HCl production under the requirements of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., and has assigned OMB control number 2060-0529. At proposal, EPA prepared a revision to the currently approved information collection request (ICR), and made it available for public comment. Most of the final rule amendments are not expected to have an impact on the ICR burden. However, the ICR was revised because two of the final rule amendments are expected to change the burden slightly. The exemption for individual emission streams that are routed to 40 CFR part 63, subpart EEE, hazardous waste combustors is expected to decrease the reporting and recordkeeping burden for some sources. The routine maintenance allowance is expected to increase the reporting and recordkeeping burden for all sources. Overall, the total annual reporting and recordkeeping burden is expected to be 733 hours (1 percent) lower than for the final rule. No comments were received on the revised ICR or burden estimates.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

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

EPA has determined that it is not necessary to prepare a regulatory flexibility analysis in connection with today's action.

For purposes of assessing the impacts of today's amendments on small entities, small entity is defined as (1) a small business as defined by the Small Business Administration's regulations at 13 CFR 121.202; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. The small business size standard for the affected industries (NAICS 325181, Alkalies and Chlorine Manufacturing; and NAICS 325188, All Other Basic Inorganic Chemical Manufacturing) is a maximum of 1,000 employees for an entity.

After considering the economic impacts of today's final rule amendments on small entities, EPA has concluded that today's action will not have a significant economic impact on a substantial number of small entities. The final rule amendments will not impose any requirements on small entities.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments and the private sector. Under UMRA section 202, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more in any 1 year. Before promulgating an EPA rule for which a written statement is needed, UMRA section 205 generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of UMRA section 205 do not apply when they are inconsistent with applicable law. Moreover, UMRA section 205 allows EPA to adopt an alternative other than the least-costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under UMRA section 203 a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

Today's final amendments contain no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, or Tribal governments. EPA has determined that the final amendments do not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any 1 year. Thus, today's final amendments are not subject to the requirements of UMRA sections 202 and 205.

Executive Order 13132 (64 FR 43255; August 10, 1999) requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the EO 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.”

The final rule amendments do not have federalism implications. They will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in EO 13132. None of the affected facilities are owned or operated by State governments. Thus, EO 13132 does not apply to the final amendments.

Executive Order 13175 (65 FR 67249; November 6, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications.” The final rule amendments do not have Tribal implications, as specified in EO 13175. They 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. No Tribal governments own facilities subject to the HCl Production NESHAP. Thus, EO 13175 does not apply to the final amendments.

EO 13045 (62 FR 19885; April 23, 1997) applies to any rule that: (1) Is determined to be “economically significant” as defined under EO 12866, and (2) concerns an environmental health or safety risk that EPA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, EPA must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by the Agency. EPA interprets EO 13045 as applying only to regulatory actions that are based on health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. The final rule amendments are not subject to EO 13045 because they are based on technology performance and not on health or safety risks.

Today's action is not subject to EO 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355; May 22, 2001) because it is not a significant regulatory action under EO 12866.

As stated in the proposed rule, section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) of 1995 (Pub. L. 104-113; 15 U.S.C 272 note), directs EPA to use voluntary consensus standards in their regulatory and procurement activities unless to do so would be inconsistent with applicable law or otherwise impracticable. Voluntary consensus standards are technical standards (such as material specifications, test methods, sampling procedures, or business practices) developed or adopted by one or more voluntary consensus bodies. The NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. The final rule amendments do not involve changes to the technical standards in the final rule. Therefore, EPA is not considering the use of any voluntary consensus standards in the final amendments.

The Congressional Review Act (CRA), 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 my take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the comptroller General of the United States. EPA will submit a report containing the final rule amendments 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 final rule amendments in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. The final rule amendments are not a “major rule” as defined by 5 U.S.C. 804(2). The final rule amendments will be effective April 7, 2006.

Throughout this document wherever “we,” or “our” are used we mean EPA. On July 21, 2004 (69 FR 43522), we published a final rulemaking announcing our approval of the redesignation of the Hazelwood SO2 Nonattainment Area and the Monongahela River Valley Unclassifiable Area, located in the Allegheny Air Basin in Allegheny County to attainment of the NAAQS for SO2 and approved a combined maintenance plan for both areas as a State Implementation Plan (SIP) revision. This action pertained to the redesignation of the Hazelwood and Monongahela River Valley areas (V.(B)(1) and V.(B)(2), respectively, of part 81, section 81.339, to attainment. This action was not intended to affect the area within a two-mile radius of the Bellevue monitor (V.(B)(3), or the remaining portions of the Allegheny County Air Basin (V.(B)(4). In the July 21, 2004 rulemaking document, these areas were inadvertently removed in the Pennsylvania SO2 Table in part 81, section 81.339. Therefore, this correction action restores the entries which were inadvertently removed.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. We have determined that there is good cause for making today's rule final without prior proposal and opportunity for comment because we are merely correcting an incorrect citation in a previous action. Thus, notice and public procedure are unnecessary. We find that this constitutes good cause under 5 U.S.C. 553(b)(B).

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). Because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedures Act or any other statute as indicated in the SUPPLEMENTARY INFORMATION section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), or to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA. This rule also 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, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it 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 governments, as specified by Executive Order 13132 (64 FR 43255, August 10, 1999). This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This technical correction action does not involve technical standards; thus the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The rule also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). In issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct, as required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996). EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1998) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order. This rule does not impose an information collection burden under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

The Congressional Review Act (5 U.S.C. 801 et seq.), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA had made such a good cause finding, including the reasons therefore, and established an effective date of April 7, 2006. 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 correction to 40 CFR 81.339 for Pennsylvania is not a “major rule” as defined by 5 U.S.C. 804(2).

FMVSS No. 114, Theft protection, specifies vehicle performance requirements intended to reduce the incidence of crashes resulting from theft and accidental rollaway of motor vehicles. The standard applies to all passenger cars, and to trucks and multipurpose passenger vehicles with a GVWR of 4536 kilograms (10,000 pounds) or less. The standard first became effective on January 1, 1970.1 The purpose of the standard was to prevent crashes caused by unauthorized use of unattended motor vehicles. Thus, the standard sought to ensure that the vehicle could not be easily operated without the key, and that the vehicle operator would not forget to remove the key from the ignition system upon exiting the vehicle.

In response to the problem of accidental rollaway crashes resulting from children inadvertently moving the automatic transmission lever to a neutral position when a stationary vehicle is parked on a slope, NHTSA later amended FMVSS No. 114 to require that the automatic transmission lever be locked in the “park” position before the key can be removed from the ignition system.2 Subsequently, NHTSA amended these new requirements to permit an override device that would enable the vehicle operator to remove the key without the transmission being locked in “park,” and to move the transmission lever without using the key, under certain circumstances. The purpose of these override provisions was to address certain situations when it may be necessary to remove the key without shifting the transmission lever because the vehicle has become disabled.3

While FMVSS No. 114 evolved to address not only theft protection, but also accidental rollaway prevention, the terminology used in the regulatory text has remained unchanged since its introduction more than 35 years ago. However, theft protection technology has advanced considerably during that time. As a result, certain provisions of the Standard have become increasingly ambiguous when applied to modern theft protection technology not contemplated by the Standard when it first went into effect.

For example, a number of vehicles now feature electronic systems. Typically, this involves a card or a similar device that is carried in an occupant's pocket or purse. The card carries an electronic code that acts as the key when it is transmitted to the vehicle's onboard locking system. The vehicle has a sensor that automatically unlocks the door and allows the vehicle operator to activate the engine, when it receives the code. The code-carrying device (i.e., card or otherwise) never has to leave the vehicle operator's pocket or purse and is not inserted into the ignition module.

In response to manufacturers' requests, NHTSA issued a series of interpretation letters explaining how the Standard applied to various key-locking systems that did not utilize conventional keys, but instead relied on electronic codes to lock and unlock the vehicle, and to enable engine activation.

As noted above, the agency has received several requests for legal interpretation of the requirements of FMVSS No. 114, as they apply to key-locking systems using various remote access devices. In response, the agency has stated that the electronic code transmitted from a remote device to the vehicle can be considered a “key” for the purposes of FMVSS No. 114.4 We have also elaborated on how other provisions of the standard apply to electronic codes. For example, the agency stated that the narrow provisions related to electrical failure do not apply to electronically coded cards or other means used to enter an electronic key code into the locking system because those provisions were specifically crafted in the context of traditional keys.5 We also explained that systems using an electronic code instead of conventional key would satisfy the rollaway prevention provisions if the code remained in the vehicle until the transmission gear is locked in the “park” position.

We have followed our interpretation of the definition of “key” in addressing other issues related to FMVSS No. 114. However, instead of continuing to rely on interpretations, and possibly facing additional questions in the future, the agency believes that it is appropriate to amend the regulatory text of FMVSS No. 114 so that it better correlates to modern antitheft technology and better reflects the agency's interpretation of the existing requirements.

In order to prevent accidental rollaways, the Standard currently requires that, for vehicles with automatic transmission, the transmission lever must be locked in “park” before the vehicle operator could remove the key.6 However, the Standard also allows an optional “override device” which permits removal of the key without the automatic transmission being locked in “park.” The standard currently specifies that this override device “* * * must be covered by a non-transparent surface which, when installed, prevents sight of and activation of the device * * *” and that “* * * The covering surface shall be removable only by use of a screwdriver or other tool.”

On October 29, 2002, NHTSA received a petition from VW asking the agency to amend S4.2.2(a) by removing provisions related to the override device covering. VW argued that these provisions are unnecessarily design-restrictive. VW indicated that there are other ways to ensure that the override device is not engaged inadvertently. Specifically, VW suggested that the agency allow an override device that requires using a tool to activate the override device while simultaneously removing the key.

The agency decided to grant the petitioner's request because we tentatively agreed that regulatory text related to the override device cover was unnecessarily design-restrictive. However, instead of addressing only the limited issues raised by VW, our NPRM took a broader approach and proposed to amend and reorganize the regulatory text of FMVSS No. 114 so that it better correlates to modern antitheft technology and reflects the agency's interpretation of the existing requirements. That proposal was published on August 17, 2005 and is discussed in further detail below.7

In the NPRM, the agency proposed to reorganize the regulatory text of the Standard. For clarity, the requirements related to theft protection would be separated from the requirements intended to prevent accidental rollaway. We also sought to clarify the regulatory text in order to avoid terminology that was unnecessarily design-restrictive. The specifics of the proposal were as follows:

1. We proposed to revise the paragraphs explaining the Standard's scope and purpose to better reflect its goal of reducing the incidence of crashes resulting from theft and also accidental rollaway of motor vehicles. This change has no substantive significance because the Standard already addresses both safety concerns, and should not be viewed as broadening the scope of the current requirements.

2. We proposed to revise the definition of “key” such that it makes it appropriate not only for conventional keys but also electronic codes and other potential means of unlocking and operating the vehicle. We believe that the new definition is broad enough to include not only electronic codes but also other technologies, including, for example, fingerprint recognition.

3. We proposed to substitute the term “gear selection control” for the term “transmission shift lever.”

4. We proposed to amend the requirement that the override device required by S4.2.1 of the current Standard be covered by a non-transparent surface. We proposed allowing an override device that requires using a tool to activate the override device while simultaneously removing the key, as an alternative to covering the device. We believe that requiring the use of a tool in order to activate this type of override device would involve sufficient complexity to prevent possible inadvertent activation by a child.8

5. We proposed to amend the override provisions of the current S4.2.2 to allow manufacturers greater flexibility in designing their override devices and to allow manufacturers the choice to use electronic theft prevention devices, such as immobilizers, instead of using steering locks, if they desire. The current Standard allows only override systems that prevent steering before the key can be released or the transmission lever can be shifted. The agency previously indicated that this requirement ensured that the theft protection aspects of the standard remained intact even in certain situations where the vehicle was disabled.9 After further evaluating this aspect of our requirements, we concluded that an override device that would prevent forward self-mobility (such as an immobilizer) instead of steering would be just as effective. As explained in our September 24, 2004 interpretation letter to a party who requested confidentiality:

We received two comments in response to the NPRM, from VW and the Alliance of Automobile Manufacturers (Alliance). VW generally supported the proposal and urged the agency to “* * * publish a Final Rule enacting the amendments as soon as possible with an effective date 60 days following publication of the Final Rule as proposed in the preamble.” Alliance strongly supported the NPRM, and agreed with NHTSA that the Standard had become outdated as a result of technological advances in theft protection. However, Alliance identified one proposed change that, it believed, was inconsistent with the agency's intent not to propose changes that would impose new substantive requirements on vehicle manufacturers.

By way of background, S4.5 of FMVSS 114 currently reads, in relevant part, as follows:

As the regulatory text indicates, the agency does not specify the type of warning that must be activated when the key is in the ignition, and the driver's door is open. By contrast, the proposed S5.1.3 specifies that a warning must be audible. Alliance argued that specifically requiring an audible warning will prohibit compliance via possible future technologies such as haptic feedback, unique visuals, etc.” The Alliance requested that the requirement for an audible warning be deleted in the final rule.

After carefully considering the comments, we decline to make the change requested by Alliance for the following reasons. First, the agency is not aware of any vehicles complying with the requirement of S4.5 in any manner except for an audible warning. Alliance did not indicate that any of their members have vehicles currently in production that would not comply with the requirements of the proposed regulatory text. Therefore, adopting the proposed change in the regulatory text would not require any changes in the current fleet. Second, we believe that with respect to S4.5, the current regulatory text is unnecessarily broad. This is because a warning must be sufficient to catch a driver's attention before he or she exits the vehicle without the keys. For example, a visual dashboard telltale might be insufficient to accomplish this goal. We believe that it is necessary to carefully examine the alternatives to audible warnings in order to make sure that they are effective in reducing likelihood of drivers leaving their keys in the vehicle. Finally, there is nothing in the regulation to prevent a manufacturer from using another type of warning in addition to the required audible warning.

This final rule was not reviewed under Executive Order 12866, “Regulatory Planning and Review.” The agency has considered the impact of this proposal under the Department of Transportation's regulatory policies and procedures, and has determined that it is not significant.

This final rule amends and reorganizes the regulatory text of 49 CFR 571.114 so that it better correlates to modern theft protection technology and better reflects the agency's interpretation of the existing requirements. Additionally, this document makes certain provisions of 49 CFR 571.114 less restrictive. Vehicle manufacturers will not have to make any changes to their vehicles as a result of this rule. The impacts of this rule are so minor that we determined that a separate regulatory evaluation is not needed.

The agency has analyzed this final rule in accordance with the principles and criteria set forth in Executive Order 13132. This rule would not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132.

Executive Order 13045 (62 FR 19885, April 23, 1997) applies to any rule that: (1) is determined to be “economically significant” as defined under E.O. 12866, and (2) concerns an environmental, health or safety risk that NHTSA has reason to believe may have a disproportionate effect on children. If the regulatory action meets both criteria, we must evaluate the environmental health or safety effects of the planned rule on children, and explain why the planned regulation is preferable to other potentially effective and reasonably feasible alternatives considered by us.

This final rule is not subject to the Executive Order 13045 because it is not economically significant as defined in E.O. 12866 and does not involve decisions based on environmental, safety or health risks having a disproportionate impact on children.

This final rule does not have any retroactive effect. Under 49 U.S.C. 21403, whenever a Federal motor vehicle safety standard is in effect, a State may not adopt or maintain a safety standard applicable to the same aspect of performance which is not identical to the Federal standard, except to the extent that the state requirement imposes a higher level of performance and applies only to vehicles procured for the State's use. 49 U.S.C. 21461 sets forth a procedure for judicial review of final rules establishing, amending or revoking Federal motor vehicle safety standards. That section does not require submission of a petition for reconsideration or other administrative proceedings before parties may file suit in court.

The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.) requires agencies to evaluate the potential effects of their final rule on small businesses, small organizations and small governmental jurisdictions. I have considered the possible effects of this rulemaking action under the Regulatory Flexibility Act and certify that it will not have a significant economic impact on a substantial number of small entities.

This final rule amends and reorganizes the regulatory text of 49 CFR 571.114 so that it better correlates to modern theft protection technology and better reflects the agency's interpretation of the existing requirements. Vehicle manufacturers, or any other small businesses, will not have to make any changes to their products as a result of this rule.

Under the Paperwork Reduction Act of 1995, a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This final rule does not include any new information collection requirements.

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) directs us to use voluntary consensus standards in our regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. The NTTAA directs us to provide Congress, through OMB, explanations when we decide not to use available and applicable voluntary consensus standards.

There are no available voluntary consensus standards that are equivalent to FMVSS No. 114.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) 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 ($120.7 million as adjusted annually for inflation with base year of 1995).

The requirements of this final rule will not result in costs of $120.7 million or more to either State, local, or tribal governments, in the aggregate, or to the private sector.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

Please note that anyone is able to 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 DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78), or you may visit http://dms.dot.gov.

NHTSA has analyzed this final rule for the purposes of the National Environmental Policy Act. The agency has determined that implementation of this action will not have any significant impact on the quality of the human environment.

Under 49 U.S.C. Chapter 301, Motor Vehicle Safety (49 U.S.C. 30101 et seq.), the Secretary of Transportation is responsible for prescribing motor vehicle safety standards that are practicable, meet the need for motor vehicle safety, and are stated in objective terms.12 “Motor vehicle safety standard” means a minimum performance standard for motor vehicles or motor vehicle equipment.13 When prescribing such standards, the Secretary must consider all relevant, available motor vehicle safety information.14 The Secretary must also consider whether a proposed standard is reasonable, practicable, and appropriate for the types of motor vehicles or motor vehicle equipment for which it is prescribed and the extent to which the standard will further the statutory purpose of reducing traffic accidents and associated deaths.15 The responsibility for promulgation of Federal motor vehicle safety standards is delegated to NHTSA.16

In this final rule, the agency carefully considered these statutory requirements.

First, this final rule reflects the agency's careful consideration and analysis of all existing regulatory provisions in FMVSS No. 114, as well as relevant letters of interpretation related to that standard. In developing the substantive provisions of the standard over the years, the agency considered all relevant, available motor vehicle safety information, including available research, testing results, and other information related to various technologies. This final rule amends and reorganizes the regulatory text of FMVSS No. 114 so that it better correlates to modern theft protection technology and reflects the agency's interpretation of the existing requirements. The new language does not impose any new substantive requirements on vehicle manufacturers.

Second, to ensure that the requirements of FMVSS No. 114 are practicable (as well as consistent with our safety objectives), the agency evaluated the cost, availability, and suitability of the standard's provisions, both when initially adopted and during subsequent amendments. As noted above, the changes resulting from this final rule are administrative in nature and would not impact the costs and benefits of the standard. In sum, we believe that this final rule is practicable and would maintain the benefits of Standard No. 114.

Third, the regulatory text following this preamble is stated in objective terms in order to specify precisely what performance is required and how performance will be tested to ensure compliance with the standard. The language of the standard has been modified to improve clarity or to incorporate existing interpretations, again without changing the substance of the existing requirements.

Fourth, we believe that this final rule would meet the need for motor vehicle safety by clarifying the safety standard, thereby making it easier for regulated parties to comply with all applicable requirements.

Finally, we believe that this final rule is reasonable and appropriate for motor vehicles subject to the applicable requirements. As discussed elsewhere in this notice, the modifications to the standard are administrative in nature. They do not affect the substance of the requirements or the bases for those requirements, as articulated in earlier rulemakings. Accordingly, we believe that this final rule is appropriate for vehicles that are subject to FMVSS No. 114 because it furthers the agency's objective to reduce the incidence of crashes resulting from theft and accidental rollaway of motor vehicles.

On June 12, 2001, we received a petition from the Environmental Protection and Information Center (EPIC), Center for Biological Diversity, and WaterKeepers Northern California requesting that we list the green sturgeon as threatened or endangered under the ESA and that critical habitat be designated for the species concurrently with any listing determination. On December 14, 2001, we provided notice of our 90-day finding that the petition presented substantial scientific information indicating that the petitioned action may be warranted and requested information to assist with a Status Review to determine if green sturgeon warranted listing under the ESA (66 FR 64793). To assist in the Status Review, we formed a Biological Review Team (BRT) comprised of scientists from our Northwest and Southwest Fisheries Science Centers and from the United States Geological Survey (USGS). We also requested technical information and comments from state and tribal co-managers in California, Oregon, and Washington, as well as from scientists and individuals having research or management expertise pertaining to green sturgeon from California and the Pacific Northwest. The BRT considered the best available scientific and commercial information, including information presented in the petition and in response to our request for information concerning the status of and efforts being made to protect the species (66 FR 64793; December 14, 2001). After completion of the Status Review (Adams et al., 2002), we determined on January 23, 2003 (68 FR 4433), that green sturgeon is comprised of two DPSs that qualify as species under the ESA: (1) a northern DPS consisting of populations in coastal watersheds northward of and including the Eel River (“Northern DPS”); and (2) a southern DPS consisting of coastal and Central Valley populations south of the Eel River, with the only known spawning population in the Sacramento River (“Southern DPS”). After consideration of a variety of information to assess risk factors, including abundance, fishing impacts, and habitat modification, destruction, and loss, we determined that neither DPS warranted listing as threatened or endangered (68 FR 4433). Uncertainties in the structure and status of both DPSs led us to add them to the Species of Concern List (formerly the candidate species list; 69 FR 19975; April 15, 2004).

On April 7, 2003, EPIC (and others) challenged our “not warranted” finding for green sturgeon. The U.S. District Court for the Northern District of California issued an order on March 2, 2004, which set aside our “not warranted” finding and remanded the matter to us for redetermination of whether green sturgeon is in danger of extinction throughout all or a significant portion of its range, or is likely to become so within the foreseeable future, because the Court was not satisfied with our examination of whether purported lost spawning habitat constituted a significant portion of either DPS' range. We reestablished the BRT and asked the BRT to consider recent scientific and commercial information available regarding the biological status of green sturgeon and to assist us in assessing the viability of the species throughout all or a significant portion of its range. We published a notice on June 18, 2004, soliciting new information beyond that considered in the previous Status Review and listing determination (69 FR 34135). Following the close of this public comment period on August 17, 2004, we convened the BRT to draft an updated Status Review and distribute the updated Status Review to co-managers (i.e., States of Washington, Oregon and California, Yurok and Hoopa Tribes, U.S. Fish and Wildlife Service (FWS), and the California Bay-Delta Program) for their review and comment. This updated Status Review was finalized on February 22, 2005.

In a Federal Register notice published on April 6, 2005 (70 FR 17386), we reaffirmed our earlier determination that the northern green sturgeon DPS does not warrant an ESA listing, but that this DPS should remain on the Species of Concern List due to remaining uncertainty in the status of, and threats faced by, the Northern DPS. We, however, revised our previous “not warranted” finding for the Southern DPS and proposed to list it as threatened under the ESA based on: (1) New information showing that the majority of spawning adults are concentrated into one spawning river (i.e., Sacramento River), thus increasing the risk of extirpation due to catastrophic events; (2) information that threats have remained severe since the first Status Review and have not been adequately addressed by conservation measures currently in place; (3) new information showing evidence of lost spawning habitat in the upper Sacramento and Feather Rivers; and (4) fishery-independent data exhibiting a negative trend in juvenile green sturgeon abundance. We also solicited comments and new or additional information regarding the status of, and critical habitat for, the Southern DPS to help develop a final listing determination and possible designation of critical habitat and ESA Section 4(d) regulations in subsequent rule-making.

A thorough account of green sturgeon biology and life history may be found in the previous determination (68 FR 4433; January 23, 2003), in the Status Review and Update (Adams et al., 2002, 2005), and in the Proposed Rule to list the Southern DPS of green sturgeon as threatened under the ESA (70 FR 17386; April 6, 2005).

Section 4 of the ESA (16 U.S.C. 1533) and implementing regulations (50 CFR part 424) set forth the procedures for adding species to the Federal list of threatened and endangered species. Section 4 requires that listing determinations be based solely on the best scientific and commercial data available, without consideration of possible economic or other impacts of such determinations, after having conducted a status review of the species and considering conservation efforts being made to protect the species. After assessing a species's level of extinction risk and identifying factors that have led to its decline, we then assess existing efforts being made to protect the species to determine if those measures ameliorate the risks faced by the species. In judging the efficacy of existing protective efforts, we rely on the joint NMFS-FWS “Policy for Evaluation of Conservation Efforts When Making Listing Decisions” (“PECE;” 68 FR 15100; March 28, 2003).

A public hearing was held on July 6, 2005, and the public comment period closed on July 27, 2005. We received 32 comments by fax, standard mail and e-mail. Thirteen of the commenters urged us to withdraw its proposal to list the Southern DPS as threatened. Ten of the commenters urged us to list the Southern DPS as endangered, not threatened, under the ESA, to revise our previous “not warranted” finding for the Northern DPS, and to invoke ESA Section 9 take prohibitions and designate critical habitat for listed entities immediately. One commenter expressed mixed views of our proposal to list the Southern DPS as threatened. Eight commenters provided no opinion on our listing determinations, but requested that we exempt certain captive populations of green sturgeon from threatened status and forthcoming ESA protections.

Comment 1: Several commenters felt that we did not have enough information to proceed with a listing and thus our proposal was arbitrary and capricious.

Response: The ESA requires that listing decisions be based solely on the best scientific and commercial data available and, therefore, does not specify a minimum level of proof required to proceed. The question as to whether there is sufficient information is an issue addressed as part of the listing decision, and the BRT makes scientific recommendations to NMFS through its Status Review and Updates that inform the listing decision. In our December 14, 2001, 90-day finding (66 FR 64793), we solicited information from the state and tribal co-managers, as well as from scientists and individuals with research or management expertise pertaining to green sturgeon from California and the Pacific Northwest, to assist with the green sturgeon Status Review. We also solicited any new information from the public since the 2001 solicitation (69 FR 34135; June 18, 2004) to assist us in updating our Status Review. On January 27, 2005, we distributed the Status Review Update to our co-managers for review. All of the information obtained during these solicitations was considered and used in developing our proposed and final listing determinations.

The BRT reiterated its recommendation that the Southern green sturgeon DPS is likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range. This recommendation was made after considering the best available information on the loss of historical habitat, the concentration of the spawning population into a single location, the trend in the salvage data, and the cumulative risk from a number of different threats in the Sacramento River and Delta system.

We concluded that the blockage of green sturgeon by dams from their original spawning grounds substantially increased extinction risk. Green sturgeon historically spawned in higher-elevation, diverse habitats in multiple rivers within the range of the Southern DPS. Construction of dams and associated impoundments, which have altered temperature and hydrologic regimes and simplified instream habitats compared to their natural spawning grounds, are believed to have substantially decreased spawning success.

The concentration of spawning into a single remaining habitat greatly increases the potential for catastrophic extinction of green sturgeon within the Southern DPS, even if green sturgeon populations were sustainable in this habitat in the long-term. The possibility of extirpation due to a catastrophic event was dramatically demonstrated by the 1991 Cantara herbicide spill. Nineteen thousand gallons of the herbicide metam sodium were released from a derailed train compartment into the Sacramento River killing nearly all aquatic life within a 45-mile segment of the river (http://www.cantaratrustees.org/spill.htm).

The green sturgeon salvage data imply a substantial decline in population numbers (see response to Comment 3 below). We remain concerned about the cumulative amount of risk to green sturgeon from a number of threats in the Sacramento River and Delta system. These threats were reviewed in the green sturgeon Status Review and Update. We are also concerned about how these different threats interact in their influence on green sturgeon. A number of ecological indicators, such as the recent collapse of the pelagic food web in the Delta, suggest that there are serious problems within the ecosystem upon which green sturgeon depend for an important portion of their life cycle. Recent unpublished reports, public presentations, and press releases by the California Department of Fish and Game (CDFG) indicate that many of the Delta's fish species have declined to the lowest levels ever recorded (http://science.calwater.ca.gov/pdf/workshops/IEP_POD_2005WorkSynthesis-draft_111405.pdf)