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6560 50 P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 63 [ OAR 2003 0197; FRL  ]

RIN 2060 AK09 Ethylene Oxide Emissions Standards for Sterilization Facilities AGENCY: Environmental Protection Agency ( EPA).

ACTION: Proposed decision; request for public comment.

SUMMARY: On December 6, 1994, we promulgated Ethylene Oxide Emission Standards for Sterilization Facilities ( 59 FR 62585). The national emission standards limit and control hazardous air pollutants ( HAP) that are known or suspected to cause cancer or have other serious health or environmental effects.

Section 112( f)( 2) of the Clean Air Act ( CAA) directs EPA to assess the risk remaining ( residual risk) after the application of national emission standards controls and revise as necessary to protect public health. Also, CAA section 112( d)( 6) requires us to review and to revise the national emission standards as necessary by taking into account developments in practices, processes, and control technologies. The proposal announces a decision and requests public comments on the residual risk assessment and technology review for the national emission standards. We 2 are proposing no further action at this time to revise the national emission standards.

DATES: Comments. Submit comments on or before [ INSERT DATE 60 45 DAYS AFTER DATE OF PUBLICATION OF THIS PROPOSED ACTION IN THE FEDERAL REGISTER], or 30 days after the date of any public hearing, if later.

Public Hearing. If anyone contacts the EPA requesting to speak at a public hearing by [ INSERT DATE 20 15DAYS AFTER DATE OF PUBLICATION OF THIS PROPOSED ACTION IN THE FEDERAL REGISTER], a A public hearing will be held on [ INSERT DATE 2815 DAYS AFTER DATE OF PUBLICATION OF THIS PROPOSED ACTION IN THE FEDERAL REGISTER] and if that date falls on a weekend, the hearing will be held the next business day.

ADDRESSES: Submit your comments, identified by Docket ID No. OAR 2003 0197 ( Legacy Docket A 88 03), by one of the following methods:

$ Federal eRulemaking Portal:

http:// www. regulations. gov. Follow the on line instructions for submitting comments.

$ Agency Website: http:// www. epa. gov/ edocket.

EDOCKET, EPA's electronic public docket and comment system, is EPA's preferred method for receiving comments. Follow the on line instructions for submitting comments.

$ E mail: a and r docket@ epa. gov $ Fax: ( 202) 566 1741 3 $ Mail: Air Docket, EPA, Mailcode: 6102T, 1200 Pennsylvania Avenue, NW, Washington, DC 20460.

Please include a total of two copies.

$ Hand Delivery: EPA, 1301 Constitution Avenue, NW,

Room B102, Washington, DC 20460. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No.

OAR 2003 0197 ( Legacy Docket A 88 03). The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http:// www. epa. gov/ edocket, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through EDOCKET, regulations. gov,

or e mail. The EPA EDOCKET and the federal regulations. gov websites are " anonymous access" systems, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e mail comment directly to EPA without going through EDOCKET or regulations. gov, your e mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on 4 the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.

Electronic files should avoid the use of special characters,

any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the EDOCKET index at http:// www. epa. gov/ edocket. Although listed in the index, some information is not publicly available, i. e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically in EDOCKET or in hard copy at the Air and Radiation Docket, EPA/ DC, EPA West, Room B102, 1301 Constitution Avenue, NW, Washington, DC. The Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is ( 202) 566 1744, and the telephone number for the Air and Radiation Docket is ( 202) 566 1742.

Public Hearing. If a The public hearing is held, it will begin at 10: 00 a. m. and will be held at the EPA 5 facility complex in Research Triangle Park, North Carolina,

or at an alternate facility nearby. Persons interested in presenting oral testimony or inquiring as to whether a public hearing is to be held must contact Mr. David Markwordt, Policy, Planning and Standards Group ( C439 04),

Emission Standards Division, EPA, Research Triangle Park, NC 27711, telephone ( 919) 541 0837 at least 2 days in advance of the hearing.

Persons interested in attending the public hearing should also call Mr. Markwordt to verify the time, date, and location of the hearing. The public hearing will provide interested parties the opportunity to present data, views,

or arguments concerning the proposed action. at least 2 days in advance of the hearing. See FOR FURTHER INFORMATION CONTACT section below for Mr. Markwordt's contact information. If no one contacts Mr. Markwordt in advance of the hearing with a request to present oral testimony at the hearing, we will cancel the hearing.

The public hearing will provide interested parties the opportunity to present data, views, or arguments concerning the proposed action.

FOR FURTHER INFORMATION CONTACT: For questions on the decision on the technology review, contact Mr. David Markwordt, EPA, Office of Air Quality Planning and Standards ( OAQPS), Emission Standards Division, Planning and Standards Group ( C439 04), Research Triangle Park, North Carolina 6 27711, telephone ( 919) 541 0837, facsimile number ( 919) 541 0942, electronic mail ( e mail) address:

" markwordt. david@ epa. gov." For questions on the residual risk analysis, contact Mr. Mark Morris, EPA, OAQPS, Emission Standards Division, Risk and Exposure Assessment Group ( C404 01), Research Triangle Park, North Carolina 27711,

telephone ( 919) 541 5416, facsimile number ( 919) 541 0840,

electronic mail ( e mail) address: " morris. mark@ epa. gov."

For additional information on this proposed decision, review the reports listed in the SUPPLEMENTARY INFORMATION section.

General and technical information. Mr. David Markwordt,

EPA, Office of Air Quality Planning and Standards, Emission Standards Division, Planning and Standards Group ( C439 04),

Research Triangle Park, North Carolina 27711, telephone ( 919) 541 0837, facsimile number ( 919) 541 0942, electronic mail ( e mail) address: " markwordt. david@ epa. gov."

Residual risk assessment information. Mr. Mark Morris,

EPA, OAQPS, Emission Standards Division, Risk and Exposure Assessment Group ( C404 01), Research Triangle Park, North Carolina 27711, telephone ( 919) 541 5416, facsimile number ( 919) 541 0840, electronic mail ( e mail) address:

" morris. mark@ epa. gov."

SUPPLEMENTARY INFORMATION:

Regulated Entities. The regulated categories and entities affected by the national emission standards include: 7 Category NAICS* Examples of regulated entities Industry.... 3841,3842........... 2834,5122,2831,2833. 2099,5149,2034,2035, 2046................ 7399,7218,8091...... Medical suppliers Pharmaceuticals Spice manufacturers Contract sterilizers * North American Information Classification System 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 the person listed in the preceeding FOR FURTHER INFORMATION CONTACT section.

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 proposed decision will also be available on the WWW through the Technology Transfer Network ( TTN). Following signature, a copy of the proposed 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. If more information 8 regarding the TTN is needed, call the TTN HELP line at ( 919)

541 5384.

Reports for Public Comment. We have prepared two summary memoranda covering the rationale for the proposed decision and the residual risk analyses. These memoranda are entitled: " Technology Review and Residual Risk Development for the Ethylene Oxide Commercial Sterilization NESHAP," and " Residual Risk Assessment for the Ethylene Oxide Commercial Sterilization Source Category." Both reports are in the Docket No. OAR 2003 0197 ( Legacy Docket A 88 03). See the preceding Docket section for docket information and availability.

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

I. Background A. What is the statutory authority for these actions? B. What is our approach for developing residual risk standards? C. What are the current standards? D. What are the results of the residual risk assessment? E. What are our conclusions regarding the need for more stringent standards under section 112( f)( 2)? F. How are we addressing GACT at Area Sources for purposes of Section 112( f)?

G. What are the results of the technology review?

II. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review B. Paperwork Reduction Act C. Regulatory Flexibility Act D. Unfunded Mandates Reform Act 9 E. Executive Order 13132: Federalism F. Executive Order 13175: Consultation and Coordination with Indian Tribal Governments G. Executive Order 13045: Protection of Children from Environmental Health & Safety Risks H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use I. National Technology Transfer Advancement Act I. Background A. What is the statutory authority for these actions?

Section 112 of the 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 national emission 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 10 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.

On December 6, 1994, 59 FR 62585, we promulgated national emission standards for Ethylene Oxide Commercial Sterilization and Fumigation Operations. In that final rule, we set MACT for major sources under section 112( d)( 2).

As for area sources, we established a MACT standard for certain emission points pursuant to section 112( d)( 2), and a GACT standard for other emission points pursuant to section 112( d)( 5).

The EPA is then required to Section 112( d)( 6) provides that EPA 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, first,

that EPA prepare a Report to Congress discussing ( among other things) methods of calculating risk posed ( or potentially 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 effects to persons in proximity to emitting sources, 11 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 phase.

Section 112( f)( 2) requires us to determine for each section 112( d) source category whether the national emission standards protect public health with an ample margin of safety. If the national emission standards 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,"

EPA must promulgate residual risk standards for the source category ( or subcategory) which as necessary to provide an ample margin of safety. The EPA must also adopt more stringent standards to prevent an adverse environmental effect ( defined in section 112( a)( 7) as " any significant and widespread adverse effect . . . to wildlife, aquatic life,

or natural resources . . .."), but must consider cost,

energy, safety, and other relevant factors in doing so.

Section 112( f)( 5) expressly provides, however, that EPA is not required to conduct any review under section 112( f)

or promulgate any emissions limitations under that subsection for any area source listed pursuant to section 12 112( c)( 3) for which EPA has issued GACT standards. Thus,

although EPA has discretion to conduct a residual risk review under section 112( f) for area sources for which it has established GACT, it is not required to do so. See CAA section 112( f)( 5).

B. What is our approach for developing residual risk standards?

Following our initial determination that the risk to the individual most exposed to emissions from a source in the category for the emissions category considered exceeds a 1 in 1 million lifetime excess cancer risk, our approach to developing residual risk standards is based on a two step determination of acceptable risk and ample margin of safety.

The first step, consideration of acceptable risk, is only a starting point for the analysis that determines the final standards. The second step determines the ample margin of safety which corresponds to the levels at which the standards are set.

The terms " individual most exposed," " acceptable level," and " ample margin of safety" are not specifically defined in the CAA. However, section 112( f)( 2)( B) retains EPA's interpretation of the terms " acceptable level" and " ample margin of safety" provided in our 1989 rulemaking ( 54 FR 38044, September 14,1989), However, CAA section 112( f)( 2)( B) refers positively to the interpretation of these terms in our 1989 rulemaking ( 54 FR 38044, September 13 1 This reading is confirmed by the Legislative History to CAA section 112( f); see, e. g., " A Legislative History of the Clean Air Act Amendments of 1990," vol. 1, page 877 ( Senate Debate on Conference Report).

2 Legislative History, vol. 1, p. 877, stating, ". . . [ T] the managers intend that the Administrator shall interpret this 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 Administrator's benzene regulations . . .."

3 " Residual Risk Report to Congress," March 1999, EPA 453/ R 99 001, page ES 11. at page ES 11, EPA 453/ R 99 001 ( March 1999). EPA prepared this Report to Congress in accordance with CAA section 112( f)( 1). The Report discusses ( among other things) methods of calculating risk posed ( or potentially posed) by sources after implementation of the NESHAP, the public health significance of those risks, the means and costs of controlling them, actual health effects to persons in proximity to emitting sources, and recommendations as 14, 1989)," National Emission Standards for Hazardous Air Pollutants ( NESHAP): Benzene Emissions from Maleic Anhydride Plants, Ethylbenzene/ Styrene Plants, Benzene Storage Vessels, Benzene Equipment Leaks, and Coke By Product Recovery Plants," ( Benzene NESHAP). We read CAA section 112( f)( 2)( B) as essentially directing EPA us to use the interpretation set out in that notice1 or to utilize approaches affording at least the same level of protection. 2 We likewise notified Congress in our " Residual Risk Report to Congress" its Residual Risk Report that we intended to use the Benzene NESHAP approach in making CAA section 112( f)

residual risk determinations. 3 14 to legislation regarding such remaining risk.

4 Id. at B 4. In the Benzene NESHAP ( 54 FR 38044 45, September 14,1989), we stated as an overall objective:

... i[ I] n protecting public health with an ample margin of safety, we strive to provide maximum feasible protection against risks to health from hazardous air pollutants by: ( 1) protecting the greatest number of persons possible to an individual lifetime risk level no higher than approximately 1 in 1 million; and ( 2) limiting to no higher than approximately 1 in 10 thousand [ i. e., 100 in a million] the estimated risk that a person living near a facility would have if he or she were exposed to the maximum pollutant concentrations for 70 years.

As explained more fully in our Residual Risk Report to Congress, these goals are not " rigid line[ s] for acceptability," but rather broad objectives to be weighed " with a series of other health measures and factors." 4 C. What are the current standards?

The Ethylene Oxide Emission Standards for Sterilization Facilities were promulgated on December 6,

1994 ( 59 FR 62585) and cover ethylene oxide, the only HAP emitted from the sterilization/ fumigation process. The national emission standards regulate both major and area sources; the emission points regulated are the main sterilization and aeration room vents. The standards for major sources require that sources reduce main sterilization and aeration room vent emissions by 99 percent. The standards for area sources require that 15 sources reduce main sterilization vent emissions by 99 percent.

During the development of the national emission standards, we estimated that there were approximately 188 facilities nationwide, of which 47 were major sources.

Usually, these operations are not located at facilities with other types of HAP emitting sources. The majority of sterilization facilities process on a contract basis, but some medical supply and spice manufacturers sterilize their own products. We estimated that the national emission standards would reduce emissions of ethylene oxide by 1,000 tons annually.

D. What are the results of the residual risk assessment?

As required by Pursuant to CAA section 112( f)( 2), we prepared a risk assessment to determine the residual risk posed by ethylene oxide sterilization facilities after implementation of the ethylene oxide national emission standards. The number of facilities in the source category has decreased since the development of the national emission standards for various reasons, including industry consolidation. We developed a list of 76 facilities that currently comprises both the entire major and area source categoryies, based on information primarily from the following three sources: ( 1) the 1999 National Emissions Inventory ( NEI), ( 2) the 2000 Toxics Release Inventory ( TRI), and ( 3) the Ethylene Oxide Sterilization Association 16 ( EOSA). We used these data sources for emissions and emission point release parameters in dispersion modeling.

As stated previously, consistent with Section 112( f)( 2), EPA must determine for each section 112( d)

source category whether the MACT standards protect public health with an ample margin of safety. Because MACT and GACT are both required of some area sources, risk attributed to GACT emission points are included in the over all modeled risks for MACT. Therefore, the risks presented below are higher than just those risks attributed solely to emission points for which we established MACT in 1994.

Using this the above noted information, we modeled ambient concentrations near these facilities and calculated the risk of possible chronic cancer and noncancer health effects and evaluated whether acute exposures might exceed relevant health thresholds. We found that individual lifetime cancer risks exceeded 1 in 1 million in areas near 44 of the 76 modeled sources, and approximately 250,000 people live in these areas. Individual lifetime cancer risks exceeded 10 in 1 million in areas near 19 sources,

and approximately 7,300 people live in these areas. The highest calculated individual lifetime cancer risk was 90

in 1 million at one facility.

An EPA assessment for ethylene oxide is currently under way. The EPA has not yet completed a full evaluation of the data on which it will determine an EPA cancer unit 17 risk estimate for ethylene oxide. When that evaluation is complete, the resulting unit risk estimate for ethylene oxide could be higher than the California EPA ( CalEPA)

cancer unit risk factor used in the risk assessment for the source category. The EPA is also developing an acute reference exposure value for ethylene oxide, which could be lower than the acute benchmarks used in the risk assessment. The schedule for both of these actions can be found at: http:// cfpub. epa. gov/ iristrac.

Under section 112( o)( 7) of the CAA, we are required to issue revised cancer guidelines prior to the promulgation of the first residual risk rule under section 112( f) ( an implication being that we should consider these revisions in the various residual risk rules). We have issued revised cancer guidelines and also supplemental guidance which deal specifically with assessing the potential added susceptibility from early life exposure to carcinogens.

The supplemental guidance provides an approach for adjusting risk estimates to incorporate the potential for increased risk due to early life exposures to chemicals that are thought to be carcinogenic by a mutagenic mode of action. We are currently evaluating the available scientific information associated with ethylene oxide to see if " age dependent adjustment factors" should be applied when assessing cancer risk for early life exposures which cause cancer through a mutagenic mode. If the scientific 18 information indicates that it is appropriate to apply age dependent adjustment factors, then we will reassess the risks from exposure to ethylene oxide prior to the promulgation of the final rule.

Estimated annual cancer incidence rates were also calculated from predicted individual cancer risks for the people reported to reside in the U. S. census blocks within the modeled area around each facility ( i. e., within 50 kilometers). For the 44 facilities for which estimated maximum individual cancer risk is greater than 1 in 1 million, the summed estimated annual cancer incidence is 0.01 cases per year. Across all 76 modeled facilities, the total estimated annual incidence is 0.04 cases per year.

We estimated that values presented here are incremental rates based on modeled concentrations and 2000 U. S. census data, and they should not be interpreted as actual cancer incidence rates derived from observations of disease occurrence over time ( such as cancer incidence rates that may be reported based on epidemiological studies).

The highest chronic noncancer hazard index was 0.03.

This means that the highest lifetime exposures to ethylene oxide were only 3 percent of the chronic noncancer reference concentration ( RfC). Finally, we found that acute exposures, which were calculated by assuming the maximum hourly emissions rate and worst case meteorological conditions, did not exceed any of the relevant health 19 thresholds for acute effects for ethylene oxide.

We are also required to consider an adverse impacts environmental effect to the environment ( e. g., ecological risks) as a part of a residual risk assessment. Regarding the inhalation exposure pathway for terrestrial mammals, we contend conclude that human toxicity values for the inhalation pathway are generally protective of terrestrial mammals. Because the maximum cancer and noncancer hazards to humans from inhalation exposure are relatively low, we expect there to be no significant and widespread adverse effects to terrestrial mammals from inhalation exposure to ethylene oxide from commercial sterilization facilities.

Some HAP which are persistent and bioaccumulative can also pose risks via pathways other than inhalation ( e. g.,

by depositing to the ground and entering the food chain).

The EPA has developed a list of persistent,

bioaccumulative, and toxic ( PBT) HAP based on information from the Pollution Prevention program, the Great Waters program, the TRI, and additional analysis conducted by the Office of Air Quality Planning and Standards. Ethylene oxide is not on the list of PBT. Consequently, we conclude the noninhalation risks to be minimal for this source category, and we conclude that a quantitative risk assessment for multipathway exposures is unnecessary.

The details of this analysis can be found in our " Memorandum: Data and Assumptions Used for the Screening 20 5 Although we conducted a risk assessment which included emissions from those vents for which we set GACT in 1994, we are exercising our discretion under section 112( f)( 5) not to undertake the 112 ( f)( 2) analysis for those GACT emission points. See CAA sections 112( f)( 2)( A),( B) and ( f)( 5). The discussion in this section of the preamble, therefore, is limited to those emission points for which we established MACT in 1994. level Residual Risk Analysis of the Commercial Ethylene Oxide Sterilizers and Fumigators Source Category" and the supporting " Memorandum: Residual Risk Assessment for Ethylene Oxide Commercial Sterilization Source Category."

See " Reports for Public Comment" in the SUPPLEMENTARY INFORMATION section above for information on obtaining these reports.

E. What are our conclusions regarding the need for more stringent standards under section 112( f)( 2)?

In the first step of the decision making process under section 112( f)( 2), the determination of acceptability, we note that the maximum individual excess lifetime cancer risk associated with any facility with MACT in the category is less than what we would normally consider as the upper limit of acceptable risk ( i. e., less than 100 in 1 million). 5 Therefore, we are satisfied that these sources represent acceptable risk without the need for further more stringent controls.

In the second step of the ample margin of safety framework under section 112( f)( 2), we consider setting standards at a level which may be equal to, or lower than, 21 the acceptable risk level and which protects public health with an ample margin of safety. In making the determination, we considered the estimate of health risk and other health information along with additional factors relating to the appropriate level of control, including costs and economic impacts of controls, technological feasibility, uncertainties, and other relevant factors.

Because our conservative risk estimates suggest facilities in the category continue to pose risks exceeding 1 in 1 million after the application of MACT, we considered additional controls, such as new technology or alternative controls, to reduce emissions and associated risks. In 2001, while investigating the safety issue associated with chamber exhaust vents, we did not find any new technology or alternative controls for any of the vents chamber,

sterilizer or aeration room vents. We also found no data to support the addition of down stream control devices to existing control means as a way of further reducing emissions. This discussion can be found in our " Memorandum: Technology Review and Residual Risk Data Development for the Ethylene Oxide Commercial Sterilization NESHAP." We concluded that further controls would not meaningfully reduce emissions at controlled from emission vents controlled with MACT at both major and area sources.

For uncontrolled vents at area sources, we concluded no additional control should be required because an ample 22 margin of safety ( considering cost, technical feasibility,

and other factors) has been achieved by the national emission standards.

While no additional control measures for controlled emission vents controlled with MACT have been identified that would result in a meaningful reduction of emissions,

we are aware of existing State rules which have control limits exceeding the 99 percent MACT requirement. The State of California's emissions reductions requirement for the main sterilizer vent is 99.9 percent; this requirement was enacted prior to promulgation of the Federal requirements.

We do not have data to confirm that all facilities are capable of achieving 99.9 percent on a continuous basis.

In 1994, in support of the Federal control limit, we concluded both rules are sufficiently stringent to require application of the same technologies. We concluded it reasonable to assume the same technologies perform similarly, i. e., those facilities outside of California are on average likely to achieve emissions reductions similar to those in California. We concluded that tightening the current standards would not meaningfully reduce risks.

The EPA requests comments specifically addressing our conclusion that the tightening of the current standards would not meaningfully reduce emissions or risks. Both EPA's and California's rules require a test to demonstrate 23 compliance with the emissions reductions limit and continuous monitoring of the control equipment to ensure proper operation and maintenance. Initial compliance tests are performed one time and on a very narrow set of operating conditions. The test results are too limited to determine if there are any meaningful differences in control technology lifetime performance associated with a 99 percent and 99.9 percent performance limit. Specifically, there are several questions on which we are requesting public comment:

Are there available test data demonstrating achievability of 99.9 percent emissions reductions on a continuous basis for the main sterilizer vent?

Are there available test data demonstrating a meaningful difference in lifetime control performance between the same technology when it is subject to either the 99 or 99.9 percent emissions reductions requirement?

Are there available test data demonstrating all similar existing control technology is capable of achieving 99.9 percent emissions reductions on a continuous basis?

Are there available data showing the variance in long term performance for similar technology complying with the 99 or 99.9 percent emissions reductions limit? 24

Are there additional costs associated with increasing the percent reduction from 99 to 99.9 percent?

In the original generally available control technology ( GACT) determination for area sources, no control requirements were established for aeration room vents and main sterilizer vents with less than 1 ton per year of ethylene oxide use due to the high cost ( 59 FR 10598 99).

There are two uncontrolled area sources with estimated risk exceeding 1 in 1 million with the highest cancer risk at 17 in 1 million. Controls would reduce risk at the plant with 17 in 1 million risk below 1 in 1 million risk at a cost effectiveness of approximately $ 50,000 per ton.

We also considered prohibiting the use of ethylene oxide for new facilities, which would necessitate the use of an alternative sterilization process. The Food and Drug Administration ( FDA) has primary authority to regulate the use of sterilization methods. The FDA issued guidance ( 510( k) Sterility Review Guidance K90 1, August 30, 2002 (" FDA Guidance")) to facilitate nontraditional sterilization methods. The FDA stated in the guidance that the FDA " has had little or no experience with these methods for achieving sterilization and is concerned about a manufacturer's ability to successfully use such methods without adversely affecting the sterility assurance level . . .." If the use of ethylene oxide were prohibited, manufacturers of products 25 requiring sterilization would have to reconsider the device and packaging material, its compatibility with the nontraditional sterilizing agent, the packaging configuration, the ability of the nontraditional sterilant to penetrate the packaging, the cost, and availability.

Because these nontraditional sterilization methods are less known, manufacturers would have to submit to FDA their validation data for review. Nontraditional sterilization operations cannot be used to sterilize materials until they have been validated. Prohibiting the use of ethylene oxide carries the risk of creating a void where some products may not be able to be sterilized until newer systems are designed and validated. Until such time as these nontraditional sterilization techniques may be used under FDA rules, these techniques are not considered available for the purpose of reducing emissions.

Radiation ( gamma and electron beam) can be used to sterilize many products. Radiation sterilization has been used for about half of the products sterilized in the U. S.

However, these sterilization techniques are limited in their applications. For example, gamma radiation has potentially damaging effects on products, particularly those products that contain polymers. And, radiation technology is completely different from chamber sterilization. Ethylene oxide and radiation technologies ( both gamma and e beam)

share no common equipment. Any conversion would involve 26 scrapping the ethylene oxide chambers and the related specialized equipment and systems, and likely displacing the existing workforce. Additionally, the ethylene oxide sterilization facility would not meet requirements for a radiation facility. To construct a radiation facility,

special shielding ( huge concrete/ lead shields) and storage pools need to be incorporated into the design of both the building and the process.

As stated previously, further controls for controlled emission vents controlled with MACT at both major and area sources do not meaningfully reduce emissions or the corresponding risks., and control requirements at uncontrolled area source vents would achieve minimal risk reduction at a very high cost. Further, the review has shown that both the noncancer and acute risks from this source category are below their relevant health thresholds.

As a result, we conclude 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 national emission standards.

Thus, we conclude that the level of risk resulting from the limits in the national emission standards is acceptable for this these source category categories, and that changes to the national emission standards are not required to satisfy section 112( f) of the CAA.

As discussed above, the EPA is developing a cancer unit 27 risk estimate for ethylene oxide that could be higher than the CalEPA value used in the risk assessment. If the EPA value becomes available before the promulgation of the final rule, and that value is higher than the value used in the risk assessment supporting this conclusion, we will reevaluate whether the risks are acceptable and whether an ample margin of safety has been achieved.

F. How are we addressing GACT at Area Sources for purposes of Section 112( f)?

As noted above, section 112( f)( 5) provides that EPA may, but is not required to, conduct any review under section 112( f) or promulgate any emissions limitations under that subsection for any area source for which an emissions standard is promugated as GACT. The CAA clearly permits EPA to review area source emissions under 112( f)( 2), even when the agency issued GACT standards under section 112( d)( 5)

during its initial review. What is less clear is what the approach should be when the agency has " mixed" its emission standards ( i. e., issued both MACT and GACT standards) for an area source category. In this instance, for example, EPA has issued MACT standards, under section 112( d)( 1), for sterilizer vents and chamber exhaust vents and GACT standards, under section 112( d)( 5), for aeration room vents.

This leaves open the question of which emissions points 28 should be reviewed under a subsequent section 112( f)( 2)

review. In this instance, EPA has undertaken an analysis under 112( f)( 2) for the area emissions standards that were issued as MACT standards, but the agency has exercised its discretion and chosen not perform an 112( f)( 2) analysis for those emissions points for which we established GACT. The agency may have other alternatives legally available,

however. For example, because the Administrator is not required to perform a residual risk analysis for any area source category when the agency has previously promulgated " an emissions standard" pursuant to 112( d)( 5), it is at least arguable that, by using the singular article " an",

Congress intended to permit the agency discretion to decline to review the area source category, in its entirety, under section 112( f)( 2) in appropriate " mixed" cases. The agency seeks comment on the agency's range of discretion under 112( f)( 5) and suggestions on what factors should guide future decisions about its approach in future rulemakings.

FG. What are the results of the technology review?

Section 112( d)( 6) of the CAA requires us to review and revise as necessary ( taking into account developments in practices, processes, and control technologies) emission standards promulgated under this section no less often than every 8 years. As described earlier in this preamble, 29 during the ample margin of safety analysis, which considered technical feasibility, cost, and emissions reductions, In the course of our review, we investigated emission control levels and the potential for additional emissions reductions from existing affected facilities within the ethylene oxide commercial sterilization source category. Because the three vents associated with these facilities, i. e., the main sterilization, aeration room, and chamber exhaust emission vents, are the same for both major and area sources, the conclusions concerning technology apply to both source categories. We found that additional controls for emission vents controlled with either MACT or GACT would achieve at best, such as new technology or other alternatives, would not meaningfully reduce risk minimal emission and risk reductions at a very high cost. In our review, we did not identify any significant developments in practices,

processes, or control technologies since promulgation of the national emission standards in 1994.

For new major sources affected facilities where MACT requires an emission reduction of 99%, we considered increasing the emissions reductions limit to 99.9 percent in the national emission standards. A new limit would only apply to affected new sources ( a new facility for the standards), while existing sources would still be subject to the current limits. As stated previously, we do not have data to confirm that facilities are capable of achieving 30 99.9 percent on a continuous basis. Therefore, the 99 percent emissions reductions requirement of the national emission standards is considered to be the best control level in practice nationally. We conclude that the new source standard for the emissions reductions limit should be kept the same as that for existing, and that no further revisions to the National Emission Standards for Ethylene Oxide Sterilization Facilities are needed.

In the original generally available control technology ( GACT) determination for new area sources, no control requirements were established due to the high cost ( 59 FR 10598 99). In our review, we did not identify any significant developments in practices, processes, or control technologies since promulgation of the national emission standards in 1994 which would reduce the costs of applying controls to new area sources.

Because the national emission standards continue to represent the best controls that can be implemented nationally, we are proposing not to revise the National Emission Standards for Ethylene Oxide Sterilization Facilities under CAA section 112( f) or 112( d)( 6).

II. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review Under Executive Order 12866 ( 58 FR 51735, October 4,

1993), EPA must determine whether a regulation is 31 " 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 government 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 or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

It has been determined that today's proposed decision is a " significant regulatory action" under the terms of Executive Order 12866 because it raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Therefore, today's proposed decision was submitted to OMB for review. However, today's proposed decision will result in no additional cost impacts beyond those estimated 32 for the current national emission standards. Changes made in response to OMB suggestions or recommendations will be documented in the public record.

B. Paperwork Reduction Act This action does not impose any new information collection burden under the provisions of the Paperwork Reduction Act, 44 U. S. C. et seq. Today's proposed decision will not change the burden estimates from those developed and approved for the national emission standards. In 1994,

OMB approved the information collection requirements for the national emission standards under the provisions of the Paperwork Reduction Act, 44 U. S. C. 3501 et seq., and assigned OMB control number 2060 0325, for ICR 1659.05.

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 33 disclose the information.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

The OMB control numbers for EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

EPA has established a public docket for this action,

which includes the ICR, under Docket ID number 2003 0197,

which can be found in www. epa. gov/ edocket. Today's proposed decision will not change the burden estimates from those developed and approved in 1994 for the national emission standards.

C. Regulatory Flexibility Act 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 impacts of today's proposed decision on small entities, small entity is defined as: ( 1) a small business whose parent company has fewer than 100 or 1,500 employees, or a maximum of $ 5 million to $ 18.5 34 million in revenues, depending on the size definition for the affected North American Industry Classification System ( NAICS) code; ( 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. It should be noted that the small business definition applied to each industry by NAICS code is that listed in the Small Business Administration ( SBA) size standards ( 13 CFR 121).

After considering the economic impacts of today's proposed decision on small entities, I certify that the decision will not have a significant economic impact on a substantial number of small entities. The proposed decision will not impose any requirements on small entities. Today's proposal announces a decision and requests public comments on the residual risk assessment and technology review for the national emission standards and imposes no additional burden on facilities impacted by the national emission standards. We are proposing no further action at this time to revise the national emission standards. We continue to be interested in the potential impacts of the proposed decision on small entities and welcome comments on issues related to such impacts.

D. Unfunded Mandates Reform Act 35 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 by State,

local, and tribal governments, in 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 36 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 today's proposed decision does not contain a Federal mandate that may result in expenditures of $ 100 million or more to State, local, and tribal governments in the aggregate, or to the private sector in any 1 year. Therefore, today's proposed decision is not subject to the requirements of sections 202 and 205 of the UMRA. In addition, today's proposed decision does not significantly or uniquely affect small governments because it contains no requirements that apply to such governments or impose obligations upon them. Therefore,

today's proposed decision is not subject to section 203 of the UMRA.

E. Executive Order 13132: Federalism 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 proposed decision does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132.

Thus, the requirements of the Executive Order do not apply to today's proposed decision.

F. Executive Order 13175, Consultation and Coordination with Indian Tribal Governments Executive Order 13175, entitled " Consultation and Coordination with Indian Tribal Governments" ( 65 FR 67249,

November 6, 2000), requires EPA to develop an accountable process to ensure " meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications." " 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 proposed decision does not have tribal implications. 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 proposed decision.

G. Executive Order 13045: Protection of Children from Environmental Health and Safety Risks 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 the Agency.

Today's proposed decision is not subject to the Executive Order because it is not economically significant as defined in Executive Order 12866 and because the Agency does not have reason to believe the environmental health or safety risk addressed by this action present a disproportionate risk to children. The public is invited to submit or identify peer reviewed studies and data, of which 39 the Agency may not be aware, that assessed results of early life exposure to ethylene oxide commercial sterilization facility emissions.

H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution, or Use Today's proposed decision is not a " significant energy action" as defined in Executive Order 13211 ( 66 FR 28355,

May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

Further, we have concluded that today's proposed decision is not likely to have any adverse energy impacts.

I. National Technology Transfer and Advancement Act of 1995 Under section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law No. 104 113,

all Federal agencies are required to use voluntary consensus standards ( VCS) in their regulatory and procurement 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, business practices) developed or adopted by one or more voluntary consensus bodies. The NTTAA requires Federal agencies to provide Congress, through annual reports to OMB, with explanations when the agency does not use available and applicable VCS.

Today's proposed decision does not involve technical 40 standards. Therefore, the requirements of the NTTAA are not applicable.

Ethylene Oxide Emissions Standards for Sterilization Facilities  Page 37 of 37 List of Subjects in 40 CFR Part 63 Environmental protection, Administrative practice and procedures, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.

Dated:

Stephen L. Johnson Administrator


[Federal Register Volume 87, Number 241 (Friday, December 16, 2022)]
[Proposed Rules]
[Pages 77044-77046]
[FR Doc No: 2022-27250]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1455; Airspace Docket No. 21-AWP-42]
RIN 2120-AA66

Proposed Amendment of Class D and E Airspace; Lemoore Naval Air
Station (NAS) (Reeves Field), CA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to modify the Class D and E surface
airspace at the airport, remove the Class E airspace designated as an
extension to a Class D or E surface area, remove the Class E airspace
extending from 1,200 feet above the surface, modify the Class E
airspace extending from 700 feet above the surface of the earth, and it
will also propose several administrative changes to update the
airport's legal description. This action would support the safety and
management of instrument flight rules (IFR) and visual flight rules
(VFR) operations at the airport.

DATES: Comments must be received on or before January 30, 2023.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
1-800-647-5527, or<PHONE_NUMBER>. You must identify Docket No. FAA-
2022-1455; Airspace Docket No. 21-AWP-42, at the beginning of your
comments. You may also submit comments through the internet at
www.regulations.gov.
    FAA Order JO 7400.11G, Airspace Designations and Reporting Points,
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Raphell P. Taylor, Federal Aviation
Administration, Western Service Center, Operations Support Group, 2200
S 216th Street, Des Moines, WA 98198; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code (U.S.C.). 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. This rulemaking is promulgated under the authority
described in Subtitle VII, Part A, Subpart I, Section 40103. Under that
section, the FAA is charged with prescribing regulations to assign the
use of airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority, as it would amend Class D and E airspace at Lemoore NAS, CA,
to support the safety and management of IFR and VFR operations at the
airport.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in
triplicate to the address listed above. Persons wishing the FAA to
acknowledge receipt of their comments on this notice must submit with
those comments a self-addressed, stamped postcard on which the
following statement is made: ``Comments to Docket No. FAA-2022-1455;
Airspace Docket No. 21-AWP-42.'' The postcard will be date/time stamped
and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this notice may be changed in light of the
comments received. A report summarizing each substantive

public contact with FAA personnel concerned with this rulemaking will
be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at www.regultions.gov. Recently published rulemaking documents
can also be accessed through the FAA's web page at www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for the address and phone number)
between 9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined during normal
business hours at the Northwest Mountain Regional Office of the Federal
Aviation Administration, Air Traffic Organization, Western Service
Center, Operations Support Group, 2200 S 216th Street, Des Moines, WA
98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11G, Airspace
Designations and Reporting Points, dated August 19, 2022, and effective
September 15, 2022. FAA Order JO 7400.11G is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11G
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA is proposing an amendment to Title 14 CFR part 71 that
would modify the Class D and E surface areas, remove the Class E
airspace area designated as an extension to a Class D or Class E
surface area, remove the Class E airspace extending upward from 1,200
feet above the surface, and modify the Class E airspace extending
upward from 700 feet above the surface at Lemoore NAS.
    The radius of the Class D surface airspace should be increased to
5.4 miles (previously 5.2 miles), which would more appropriately
contain IFR departure operations while between the surface and the base
of adjacent controlled airspace.
    The Class E2 airspace should be modified to be coincident with the
Class D airspace legal description.
    The Class E4 airspace at the airport should be removed. The
proposed lateral boundaries of the Class D and E2 surface areas are
sufficient to contain IFR aircraft on instrument approaches when less
than 1,000 feet above the surface.
    The north and southeast extensions to the Class E5 airspace
extending upward from 700 feet above the surface are no longer needed
and should be removed. A Class E5 area extending upward from 700 feet
above the surface within a 7.9-mile radius airspace area about the
airport is sufficient to contain IFR arrivals descending below 1,500
feet above the surface and IFR departures to 1,200 feet above the
surface.
    The Class E5 airspace extending upward from 1,200 feet above the
surface at the airport should be removed as the area is already
contained within the Sacramento Class E domestic en route airspace, and
duplication is not necessary.
    Additionally, the FAA proposes administrative modifications to the
airport's legal descriptions. The term ``NAS'' is not associated with
the correct city information in the first line of the text header in
the Class D and E2 legal descriptions, and it should be removed. The
terms ``Notice to Airmen'' and ``Airport/Facility Directory'' in the
Class D and E2 airspace descriptions should be updated to read ``Notice
to Air Missions'' and ``Chart Supplement,'' respectively, to match the
FAA's current nomenclature. The airport name in the second line of the
legal description text headers should be corrected. The name
``LeMoore'' should be replaced with ``Lemoore,'' to more accurately
describe the airport. The third line of the text header currently
references the Lemoore NAS Tactical Air Navigation (TACAN) navigational
aid, but should list the airport's geographic coordinates instead, as
it simplifies the airspace's legal description. This line should read
``(lat. 36[deg]19'59'' N, long. 119[deg]57'08'' W).'' and the reference
to the Lemoore NAS TACAN should be removed, as it is no longer needed
to describe the airspace.
    Class D, E2, E4, and E5 airspace designations are published in
paragraphs 5000, 6002, 6004, and 6005, respectively, of FAA Order JO
7400.11G, dated August 19, 2022, and effective September 15, 2022,
which is incorporated by reference in 14 CFR 71.1. The Class D and
Class E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11, which is published yearly and
becomes effective on September 15. FAA Order JO 7400.11, Airspace
Designations and Reporting Points is published yearly and effective on
September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) is not a ``significant regulatory action''
under Executive Order (E.O.) 12866; (2) is not a ``significant rule''
under DOT regulatory policies and procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, would not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, Environmental Impacts: Policies and
Procedures, prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by Reference, Navigation (air).

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me, the FAA
proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(f), 106(g), 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11G, Airspace Designations and Reporting Points, dated August 19,
2022, and effective September 15, 20122 is amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

AWP CA D Lemoore, CA [Amended]

Lemoore NAS (Reeves Field), CA
    (Lat. 36[deg]19'59'' N, long. 119[deg]57'08'' W)

    That airspace extending upward from the surface to and including
2,700 feet MSL within a 5.4-mile radius of the airport. This Class D
airspace area is effective during the specific dates and times
established in advance by a Notice to Air Missions. The effective
date and time will thereafter be continuously published in the Chart
Supplement.
* * * * *

Paragraph 6002 Class E Airspace Areas Designated as a Surface Area.

* * * * *

AWP CA E2 Lemoore, CA [Amended]

Lemoore NAS (Reeves Field), CA
    (Lat. 36[deg]19'59'' N, long. 119[deg]57'08'' W)

    That airspace extending upward from the surface within a 5.4-
mile radius of the airport. This Class E airspace area is effective
during the specific dates and times established in advance by a
Notice to Air Missions. The effective date and time will thereafter
be continuously published in the Chart Supplement.
* * * * *

Paragraph 6004 Class E Airspace Areas Designated as an Extension to
a Class D or Class E Surface Area.

* * * * *

AWP CA E4 Lemoore NAS, CA [Removed]

Lemoore NAS (Reeves Field), CA
    (Lat. 36[deg]19'59'' N, long. 119[deg]57'08'' W)

Lemoore TACAN
    (Lat. 36[deg]20'39'' N, long. 119[deg]57'59'' W)

    That airspace extending upward from the surface within 1.8 miles
each side of the Lemoore TACAN 335[deg] and 357[deg] radials,
extending from the 5.2-mile radius of Lemoore NAS (Reeves Field) to
7 miles northwest and north of the TACAN, and within 1.8 miles each
side of the Lemoore TACAN 155[deg] radial, extending from the 5.2-
mile radius to 7 miles southeast of the TACAN.
* * * * *

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AWP CA E5 Lemoore, CA [Amended]

Lemoore NAS (Reeves Field), CA
    (Lat. 36[deg]19'59'' N, long. 119[deg]57'08'' W)

    That airspace extending upward from 700 feet above the surface
within a 7.9-mile radius of the airport.
* * * * *

    Issued in Des Moines, Washington, on December 8, 2022.
B.G. Chew,
Group Manager, Operations Support Group, Western Service Center.
[FR Doc. 2022-27250 Filed 12-15-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 77, Number 20 (Tuesday, January 31, 2012)]
[Notices]
[Page 4853]
[FR Doc No: 2012-2161]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

In the Matter of Airbee Wireless, Inc., Axial Vector Engine Corp.
(n/k/a Avec Corporation), and Exploration Drilling International, Inc.;
Order of Suspension of Trading

January 27, 2012.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Airbee Wireless, Inc. because it has not filed any periodic reports
since the period ended September 30, 2008.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Axial Vector Engine Corp. (n/k/a Avec Corporation) because it has not
filed any periodic reports since the period ended March 31, 2007.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Exploration Drilling International, Inc. because it has not filed any
periodic reports since the period ended September 30, 2008.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EST on January 27, 2012, through 11:59
p.m. EST on February 9, 2012.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. 2012-2161 Filed 1-27-12; 4:15 pm]
BILLING CODE 8011-01-P


Mission Statement for PPDC AZM Transition Issues Workgroup

EPA and USDA are committed to working towards a reasonable transition
for pesticide uses which have been cancelled or phased-out under FIFRA
and FQPA. To that end, EPA and USDA are co-sponsoring a workgroup on
transition issues under the auspices of the EPA Pesticide Program
Dialogue Committee (PPDC) -- an advisory committee chartered under the
Federal Advisory Committee Act (FACA). This AZM Transition Issues
Workgroup’s focus will be to provide advice (through the PPDC) to EPA
and USDA on the implementation of EPA’s decision to phase out the
remaining uses of the organophosphate, azinphos-methyl (AZM), over the
next few years. EPA expects that this phase-out will encourage and
facilitate transition to safer alternatives and reduce risks to
farmworkers, pesticide applicators, and aquatic ecosystems. EPA and USDA
want this workgroup to help focus our efforts on the key activities
needed for the successful transition.

The objectives and goals of this PPDC workgroup include:

1. Identifying a framework for reasonable transition towards lower risk
strategies, taking into account grower concerns over economic, trade and
regulatory barriers to adoption of alternatives;

2. Identifying ways to improve understanding of the critical grower
needs and perspectives of all stakeholders regarding the transition;

3. Identifying programs/mechanisms to provide reduced-risk pest
management strategies and techniques to growers – including chemical
and non-chemical alternatives to AZM;

4. Recommending ways to assist growers in their good faith efforts as
they try AZM alternatives and feasible, cost-effective techniques;

5. Fostering transparency and public participation in decision-making;
and,

6. Providing process recommendations to ensure that AZM transition
progress is tracked and assessed and reported back to the PPDC.


[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Page 76021]
[FR Doc No: 2010-30607]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-1940-DR; Docket ID FEMA-2010-0002]

Arizona; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Arizona (FEMA-1940-DR), dated October 4, 2010, and
related determinations.

DATES: Effective Date: November 22, 2010.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Arizona is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of October 4, 2010.

    The Hopi Tribe for Public Assistance. The following Catalog of
Federal Domestic Assistance Numbers (CFDA) are to be used for
reporting and drawing funds: 97.030, Community Disaster Loans;
97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster
Legal Services; 97.034, Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant; 97.048, Disaster Housing
Assistance to Individuals and Households in Presidentially Declared
Disaster Areas; 97.049, Presidentially Declared Disaster
Assistance--Disaster Housing Operations for Individuals and
Households; 97.050, Presidentially Declared Disaster Assistance to
Individuals and Households--Other Needs; 97.036, Disaster Grants--
Public Assistance (Presidentially Declared Disasters); 97.039,
Hazard Mitigation Grant.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2010-30607 Filed 12-6-10; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 152 (Thursday, August 7, 2014)]
[Notices]
[Page 46292]
[FR Doc No: 2014-18772]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Green and Hill Industries, Inc.; Order of Suspension of Trading

August 5, 2014.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Green and Hill Industries, Inc., d/b/a Ross' Gold, because of questions
regarding the accuracy of publicly available information about the
company's operations. Green and Hill Industries, Inc. is a Nevada
corporation with its principal place of business located in Toronto,
Ontario, Canada. Its stock is quoted on OTC Link, operated by OTC
Markets Group Inc., under the ticker: GHIL.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed company.
    Therefore, it is ordered, pursuant to Section 12(k) of the
Securities Exchange Act of 1934, that trading in the securities of the
above-listed company is suspended for the period from 9:30 a.m. EDT on
August 5, 2014, through 11:59 p.m. EDT on August 18, 2014.

    By the Commission.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-18772 Filed 8-5-14; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register Volume 87, Number 81 (Wednesday, April 27, 2022)]
[Proposed Rules]
[Pages 24903-24905]
[FR Doc No: 2022-08891]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-0434; Airspace Docket No. 19-AAL-69]
RIN 2120-AA66

Proposed Amendment of United States Area Navigation (RNAV) Route
T-260; Nome, AK

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend United States Area Navigation
(RNAV) T-route, T-260 in the vicinity of Nome, AK. The RNAV amendments
are necessary due to the planned decommissioning of the Tin City, AK,
(TNC) Non-Directional Beacons (NDB)/Distance Measuring Equipment (DME)
and the Point Hope, AK, (PHO) NDB. Both NDBs will decommission as part
of a large and comprehensive T-route modernization project for the
state of Alaska. Although the Tin City, AK, (TNC) NDB will
decommission, the co-located Distance Measuring Equipment (DME) will
remain for use within the National Airspace System (NAS).

DATES: Comments must be received on or before June 13, 2022.

ADDRESSES: Send comments on this proposal to the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590; telephone:
(800) 647-5527, or<PHONE_NUMBER>. You must identify FAA Docket No.
FAA-2022-0434; Airspace Docket No. 19-AAL-69 at the beginning of your
comments. You may also submit comments through the internet at https://www.regulations.gov.
    FAA Order JO 7400.11F, Airspace Designations and Reporting Points,
and

subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Rules and Regulations Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: Jesse Acevedo, Rules and Regulations
Group, Office of Policy, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. 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. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
the airspace necessary to ensure the safety of aircraft and the
efficient use of airspace. This regulation is within the scope of that
authority as it would expand the availability of RNAV in Alaska and
improve the efficient flow of air traffic within the NAS by lessoning
the dependency on ground based navigation.

Comments Invited

    Interested parties are invited to participate in this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (FAA Docket No.
FAA-2022-0434; Airspace Docket No. 19-AAL-69) and be submitted in
triplicate to the Docket Management Facility (see  ADDRESSES section
for address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Commenters wishing the FAA to acknowledge receipt of their comments
on this action must submit with those comments a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to FAA Docket No. FAA-2022-0434; Airspace Docket No. 19-AAL-69.'' The
postcard will be date/time stamped and returned to the commenter.
    All communications received on or before the specified comment
closing date will be considered before taking action on the proposed
rule. The proposal contained in this action may be changed in light of
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRM

    An electronic copy of this document may be downloaded through the
internet at https://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays. An informal docket may also be examined during normal
business hours at the office of the Western Service Center, Operations
Support Group, Federal Aviation Administration, 2200 South 216th St.,
Des Moines, WA 98198.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11F, Airspace
Designations and Reporting Points, dated August 10, 2021, and effective
September 15, 2021. FAA Order JO 7400.11F is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11F
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

Background

    In 2003, Congress enacted the Vision 100--Century of Aviation
Reauthorization Act (Pub L., 108-176), which established a joint
planning and development office in the FAA to manage the work related
to the Next Generation Air Transportation System (NextGen). Today,
NextGen is an ongoing FAA-led modernization of the nation's air
transportation system to make flying safer, more efficient, and more
predictable.
    In support of NextGen, this proposal is part of a larger and
comprehensive RNAV T-route modernization project in the state of
Alaska. The project's mission statement is ``to modernize Alaska's Air
Traffic Service route structure using satellite based navigation.
Development of new T-routes and optimization of existing T-routes will
enhance safety, increase efficiency and access, and will provide
enroute continuity that is not subject to the restrictions associated
with ground based airway navigation.'' As part of this project, the FAA
evaluated the existing Colored airway structure for: (a) Direct
replacement (i.e., overlay) with a T-route that offers a similar or
lower Minimum Enroute Altitude (MEA) or Global Navigation Satellite
System Minimum Enroute Altitude (GNSS MEA); (b) the replacement of the
Colored airway with a T-route in an optimized but similar geographic
area, while retaining similar or lower MEA; or (c) removal with no
route structure (T-route) restored in that area because the value was
determined to be insignificant.
    Industry and users have indicated a desire that the FAA transition
the Alaskan enroute navigation structure away from any dependency on
NDBs, and move to develop and improve the RNAV route structure. The FAA
believes this request is time sensitive given the increasing number of
NDBs that are currently and/or scheduled out of service, and the lack
of an NDB acquisition, maintenance, or sustainment program, which
forces aircraft flying under Instrument Flight Rules (IFR) that are
without de-icing protection to fly at higher MEAs, with the potentially
associated loss of safety.
    The FAA is proposing to amend RNAV T-route T-260. This proposed
action is necessary due to the planned decommissioning of the Tin City,
AK, (TNC) NDB and the Point Hope, AK, (PHO) NDB. Both NDBs will
decommission as part of the RNAV modernization effort for the state of
Alaska. The FAA proposes to replace the TNC and PHO, AK NDBs with the
FEDEV and VANTY waypoints (WPs), respectively. Although the TNC NDB
will decommission, the co-located DME will remain for use within the
NAS. Further, this proposed amendment action would improve the RNAV
satellite-based air traffic network in Alaska by planning for the
future connectivity of future RNAV T-routes.

The Proposal

    The FAA is proposing an amendment to 14 CFR part 71 to amend RNAV
route T-260 in the vicinity of Nome, AK in support of a large and
comprehensive T-route modernization project in the state of Alaska. The
proposed RNAV T-route amendment is described below.
    T-260: T-260 currently extends between the Point Hope, AK, (PHO)
NDB and the NOME, AK, (OME) VHF Omnidirectional Radar/Distance
Measuring Equipment (VOR/DME). The FAA proposes to replace the Point
Hope, AK (PHO) NDB and the Tin City, AK, (TNC) NDB/DME with the VANTY
and FEDEV WPs, respectively. The FAA also proposes to remove the COGNU,
AK, WP from the legal description due to it having less than a 1 degree
turn and is not required. As a result, T-260 would extend between the
VANTY, AK, WP and the Nome, AK, VOR/DME.
    United States Area Navigation Routes are published in paragraph
6011 of FAA Order JO 7400.11F dated August 10, 2021 and effective
September 15, 2021, which is incorporated by reference in 14 CFR 71.1.
The RNAV route listed in this document would be published subsequently
in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

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

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order JO
7400.11F, Airspace Designations and Reporting Points, dated August 10,
2021, and effective September 15, 2021, is amended as follows:

Paragraph 6011 United States Area Navigation Routes

* * * * *

T-260 Nome, AK (OME) to VANTY, AK [Amended]

Nome, AK (OME)                VOR/DME             (Lat. 64[deg]29'06.39'' N, long. 165[deg]15'11.43'' W)
FEDEV, AK                     WP                  (Lat. 65[deg]33'37.84'' N, long. 167[deg]55'18.90'' W)
VANTY, AK                     WP                  (Lat. 68[deg]20'40.64'' N, long. 166[deg]48'09.96 '' W)

* * * * *

    Issued in Washington, DC, on April 20, 2022.
Scott M. Rosenbloom,
Manager, Airspace Rules and Regulations.
[FR Doc. 2022-08891 Filed 4-26-22; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: October 9, 2007 (Volume 72, Number 194)]
[Notices]
[Page 57368-57369]
[DOCID:fr09oc07-121]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56589; File No. SR-NYSE-2007-85]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Temporary Waiver of the Specialist Marketing and Investor
Education Fee for Specialists in Certain Listed Investment Company
Units

October 1, 2007.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 25, 2007, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
The Exchange has designated this proposal as one establishing or
changing a due, fee, or other charge imposed by NYSE under Section
19(b)(3)(A)(ii) of the Act \3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 17 CFR 240.19b-4(f)(2).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes, for the period from August 1, 2007 to
December 1, 2007, to waive the Specialist Marketing and Investor
Education Fee (``Fee'') for those specialists in listed Investment
Company Units (``ICUs'') otherwise subject to such fee that have been
reallocated following the previous specialist's withdrawal from
registration as specialist in such ICUs.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. NYSE has substantially prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange currently imposes the Fee on Exchange specialists in
ICUs in circumstances where the Exchange undertakes to provide funds to
a third party for marketing and investor education in connection with
the listing of those ICUs (also known as exchange traded funds).\5\ The
Exchange states that the fee is imposed in a fair and equitable manner
on all specialists trading the securities subject to a third party fee
or payment.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 51872 (June 17,
2005), 70 FR 36683 (June 24, 2005) (SR-NYSE-2005-42).
---------------------------------------------------------------------------

    The amount paid by the specialists is calculated and apportioned
following each calendar quarter among the specialist units allocated
ICUs that are subject to an Exchange payment to third parties. This
amount represents five-sixths (83.33%) of the annual amount payable by
the Exchange, as apportioned for the quarter. Such amount is
apportioned to specialist units for each ICU that is subject to the
Fee, calculated based on the ``Notional NYSE ADV'' for each relevant
ICU. Notional NYSE ADV is defined as the average daily share volume on
the NYSE for the calendar quarter for the particular ICU multiplied by
the average consolidated closing price for the quarter for such ICU.
    One of the specialist units previously registered in a number of
the ICUs subject to the Fee notified the Exchange in July 2007 of its
intention to withdraw from registration as specialist from the Exchange
in all listed products. As a result, the Exchange was required to
reallocate these ICUs to other specialist units within a short time
frame following notification by the previous specialist unit. This
reallocation was accomplished on August 1, 2007. Under these
circumstances, given that the specialist firms, to which the ICUs were
reallocated on short notice, were not able to anticipate or budget for
the expense, the Exchange considered it necessary, appropriate, and
equitable to waive the Fee with respect to such reallocated ICUs for
the period August 1, 2007 to December 1, 2007.

2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with Section 6(b) of the Act,\6\ in general, and furthers the
objectives of Section 6(b)(4) of the Act,\7\ in particular, in that it
is designed to provide for the equitable allocation of reasonable dues,
fees, and other charges among Exchange members, issuers, and other
persons using the facilities of the Exchange.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f(b).
    \7\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change would
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    The foregoing proposed rule change has been designated as a fee
change pursuant to Section 19(b)(3)(A)(ii) of the Act \8\ and Rule 19b-
4(f)(2) \9\ thereunder, because it establishes or changes a due, fee,
or other charge imposed by the Exchange. Accordingly, the proposal will
take effect upon filing with the Commission. At any time within 60 days
of the filing of the proposed rule change, the Commission may summarily
abrogate such rule change if it appears to the Commission that such
action is necessary or appropriate in the public interest, for the
protection of investors, or otherwise in the furtherance of the
purposes of the Act.
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    \8\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \9\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NYSE-2007-85 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2007-85. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-NYSE-2007-85 and should be
submitted on or before October 30, 2007.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\10\
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    \10\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E7-19749 Filed 10-5-07; 8:45 am]

BILLING CODE 8011-01-P