Background

On June 4, 2010, the Bureau of Industry and Security published a final rule that, inter alia, clarified language regarding certain performance criteria of turning machines covered by Export Control Classification Number (ECCN) 2B001 and replaced a subscript with a superscript to properly express exponentiation in the definition of Adjusted Peak Performance in a technical note at the end of Category 4 on the Commerce Control List (75 FR 31678, June 4, 2010). That notice contained two typographical errors. The first described the national security control for ECCN 2B001 as NS Column 1 on the EAR Country Chart (15 CFR part 738, Supp. No. 1). The correct national security control for ECCN 2B001 is NS Column 2. The second did not enclose the abbreviation “APP” in double quotation marks. This rule corrects both errors.

1. This rule is not a significant rule for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid Office of Management and Budget Control Number. This rule involves a collection of information that has been approved by the OMB under control number 0694-0088, which carries a burden hour estimate of 58 minutes to prepare and submit form BIS-748. Miscellaneous and recordkeeping activities account for 12 minutes per submission. BIS believes that this rule will make no change to the number of submissions or to the burden imposed by this collection.

3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132.

4. BIS finds that there is good cause under 5 U.S.C. 553(b)(3)(B) to waive the provisions of the Administrative Procedure Act requiring prior notice and the opportunity for public comment because these revisions are administrative in nature and do not affect the rights and obligations of the public; therefore allowing prior notice and comment on these rules is unnecessary. In addition, the 30-day delay in effectiveness required by 5 U.S.C. 553(d) is not applicable here because this rule is not a substantive rule, but merely makes technical changes to the regulations. No other law requires that notice of proposed rulemaking and an opportunity for public comment be given for this rule; therefore, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable.

This document contains amendments to 26 CFR part 1. On June 14, 2007, temporary regulations (TD 9330; 72 FR 32792) regarding the treatment of prepaid income under the built-in gain provisions of section 382(h) were published in the Federal Register . A notice of proposed rulemaking (NPRM) (REG-144540-06) cross-referencing to temporary regulations was published in the Federal Register for the same day (72 FR 32828). The temporary regulations provided that prepaid income is not recognized built-in gain (“RBIG”) for purposes of section 382(h). They further provided that prepaid income means any amount received prior to the change date that is attributable to performance occurring on or after the change date. Examples of prepaid income include, but are not limited to, income received prior to the change date that is deferred until the five year section 382 recognition period under section 455, § 1.451-5, or Rev. Proc. 2004-34 (2004-1 CB 991 (June 1, 2004)) (or any successor revenue procedure) ( see § 601.601(d)(2)(ii)( b )). These prepaid income provisions permit deferral in order to better match the taxpayer's income with the expenses incurred to earn that income and, as a result, to more clearly reflect the taxpayer's income both in the year of receipt and in the year of performance. The IRS and the Treasury Department therefore view such income to be properly attributable to the period when included in gross income, which may be within the recognition period. Accordingly, such income is not “attributable to periods before the change date” and so is not RBIG under section 382(h)(6)(A).

One comment was received and no public hearing was requested or held. The public comment focused on companies in the business of providing extended warranty coverage for automobiles or other products. The commenter presented an example under the facts of which the commenter argued that a portion of the prepaid income deferred to the recognition period should be treated as RBIG.

After giving consideration to the comment, the IRS and Treasury continue to believe that none of the prepaid income taken into account during the recognition period in the example should be RBIG. As noted above, where prepaid income is properly deferred from gross income under a permissible method of accounting, such deferral reflects a judgment that the income has not been earned, or, in the parlance of section 382(h)(6)(A), is not “attributable to” prior performance. The premise of this Treasury decision is that, for purposes of section 382, there is not a compelling policy underlying section 382(h) that warrants a different timing answer for the treatment of properly deferred prepaid income.

Accordingly, the proposed regulations set forth in the NPRM (REG-144540-06), which cross-referenced to the temporary regulations for their substance, are adopted with no substantive change by this Treasury decision, and the corresponding temporary regulations are removed.

It has been determined that this regulation is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. Pursuant to 5 U.S.C. 553(d)(3), it has been determined that good cause exists to dispense with a delayed effective date on grounds that this regulation, which is substantively identical to currently effective temporary regulations, merely continues to provide necessary guidance to taxpayers with respect to the treatment of prepaid income under the built-in gain provisions of section 382(h). It is hereby certified that these regulations will not have a significant economic impact on a substantial number of small entities. These regulations only apply in the rare circumstance in which a qualifying loss corporation that uses a particular accounting method undergoes an ownership change. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these final regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business.

The principal author of these regulations is Keith E. Stanley of the Office of Associate Chief Counsel (Corporate). Other personnel from the IRS and the Treasury Department participated in their development.

Background

This document amends the Procedure and Administration Regulations (26 CFR part 301) by adding rules under section 6404(g) relating to the suspension of interest, penalties, additions to tax, or additional amounts with respect to listed transactions or undisclosed reportable transactions. Section 3305 of the Internal Revenue Service Restructuring and Reform Act of 1998, Public Law 105-206 (112 Stat. 685, 743) (RRA 98), added section 6404(g) to the Code, effective for taxable years ending after July 22, 1998. Section 6404(g) generally suspends interest and certain penalties if the IRS does not contact a taxpayer regarding possible adjustments to the taxpayer's liability within a specified period of time. Section 903(c) of the American Jobs Creation Act of 2004, Public Law 108-357 (118 Stat. 1418, 1652) (AJCA), excepted from the general interest suspension rules any interest, penalty, addition to tax, or additional amount with respect to a listed transaction or an undisclosed reportable transaction, effective for interest accruing after October 3, 2004. Section 303 of the Gulf Opportunity Zone Act of 2005, Public Law 109-135 (119 Stat. 2577, 2608-09) (GOZA), modified the effective date of the exception from the suspension rules for certain listed and reportable transactions. Section 426(b) of the Tax Relief and Health Care Act of 2006, Public Law 109-432 (120 Stat. 2922, 2975), provided a technical correction regarding the authority to exercise the “reasonably and in good faith” exception to the effective date rules. Section 8242 of the Small Business and Work Opportunity Tax Act of 2007, Public Law 110-28 (121 Stat. 190, 200), extended the current eighteen-month period within which the IRS can, without suspension of interest, contact a taxpayer regarding possible adjustments to the taxpayer's liability to thirty-six months, effective for notices provided after November 25, 2007.

On June 21, 2007, the Treasury Department and the IRS published in the Federal Register temporary regulations (TD 9333), 2007-33 IRB 350 (72 FR 34176) and a notice of proposed rulemaking (REG-149036-04), 2007-33 IRB 365 (72 FR 34204) by cross-reference to temporary regulations. No written comments were received, and no public hearing was requested or held. Accordingly, the final regulations adopt the rules of the temporary regulations and the temporary regulations are removed. See § 601.601(d)(2)(ii)(b).

It has been determined that this Treasury decision is not a significant regulatory action as defined in Executive Order 12866. A regulatory assessment is therefore not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because these regulations do not impose a collection of information on small entities, the provisions of the Regulatory Flexibility Act (5 U.S.C. chapter 6) do not apply. Pursuant to section 7805(f) of the Internal Revenue Code, the NPRM by cross-reference to temporary regulations preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business and no comments were received.

The principal author of these regulations is Matthew Lucey of the Office of Associate Chief Counsel (Procedure and Administration).

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the permit application was not received in time to publish an NPRM followed by a final rule before the effective date.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property.

This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with a fireworks display. Based on the explosive hazards of fireworks, the Captain of the Port Sault Sainte Marie has determined that fireworks launches proximate to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, darkness punctuated by bright flashes of light, alcohol use, and debris falling into the water presents a significant risk of serious injuries or fatalities. Establishing a temporary safety zone to control vessel movement around the location of the launch platform will help ensure the safety of persons and property at this event and help minimize the associated risks.

A temporary safety zone is necessary to ensure the safety of spectators and vessels during the setup and launching of fireworks in conjunction with the Michigan Orthopaedic Society 50th Anniversary Fireworks display. The fireworks display will occur between 9:45 p.m. and 11 p.m. on June 19, 2010.

The safety zone will be enforced from 9 p.m. to 11 p.m. on June 19, 2010. The safety zone for the fireworks will encompass all waters of Lake Huron within a 500-foot radius of the fireworks launch site, approximately 460 yards south of Biddle Point, at position 45°50′32.82″ N., 084°37′03.18″ W: [DATUM: NAD 83].

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Sector Sault Sainte Marie, or his on-scene representative. The Captain of the Port or his on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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

This determination is based on the minimal time that vessels will be restricted from the zone and the zone is an area where the Coast Guard expects insignificant adverse impact to mariners from enforcement of the zone.

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

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

This rule will affect the following entities, some of which may be small entities: The owners and operators of vessels intending to transit or anchor in a portion of Lake Huron, Mackinac Island, Michigan, between 9 p.m. and 11 p.m. on June 19, 2010.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be in effect for two hours for one event. Vessel traffic can safely pass outside the safety zone during the event. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Sault Sainte Marie to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule establishes a safety zone and therefore paragraph (34)(g) of figure 2-1 applies. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) because the publishing of an NPRM would be impracticable and contrary to public interest since immediate action is needed to ensure the public's safety during construction activity. Delaying the implementation of the safety zone would subject the public to the hazards associated with the reconstruction of the transmission towers. The danger posed by marine traffic on the Columbia River makes safety zone regulations necessary to provide for the safety of construction support vessels, spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during construction. The Coast Guard will issue broadcast notice to mariners to advise vessel operators of navigational restrictions.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Due to the need for immediate action, the restriction of vessel traffic is necessary to protect life, property and the environment; therefore, a 30-day notice is impracticable. Delaying the effective date would be contrary to the safety zone's intended objectives of protecting persons and vessels involved in the event, and enhancing public and maritime safety

Wilson Construction Company (WCC) has been contracted to replace 12 power lines that cross the Columbia River and reconstruct four transmission towers on the banks of the Columbia River near Hermiston, Oregon between June 10, 2010 and October 31, 2011. The company will be using a helicopter to string the new lines and replace the towers. Due to the inherent dangers associated with this type of work, a safety zone is necessary to help ensure the safety of the workers involved as well as the maritime public in general.

The safety zone created by this rule encompasses all waters of the Columbia River between two lines: The east line starting at the north bank at 45° 56′ 16.5″ N/119° 19′ 24″ W then across the river to the south bank at 45° 55′ 47″ N/119° 19′ 07″ W and the west line starting at the north bank at 45° 56′ 05″ N/119° 19′ 48″ W and then across the river to the south bank at 45° 55′ 44″ N/119° 19′ 38″ W. Geographically this location is from the West bridge of I-82 east approximately 1,200 feet toward the McNary Dam.

The safety zone will be in effect from 10 a.m. on June 10, 2010 through 11:59 p.m. on October 31, 2011. All persons and vessels are prohibited from entering or remaining in the safety zone unless authorized by the Captain of the Port or his designated representative. Vessels will be allowed to transit through the safety zone during designated times throughout the duration as coordinated by the on-scene designated representative of the Captain of the Port.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. The Coast Guard has made this finding based on the fact that the Captain of the Port and/or his designated representative will allow maritime traffic to transit through the safety zone when it is safe to do so.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities some of which may be small entities: the owners and operators of vessels intending to operate in the area covered by the safety zone created in this rule between June 10, 2010 and October 31, 2011. The safety zone will not have a significant economic impact on a substantial number of small entities, however, because the Captain of the Port and/or his designated representative will allow maritime traffic to transit through the safety zone when it is safe to do so.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves the establishment of a temporary safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because any delay encountered in this regulation's effective date by publishing a NPRM would be contrary to public interest since immediate action is needed to provide for the safety of life and property on navigable waters. Additionally, this temporary safety zone will be enforced for approximately two hours on Sunday, July 4, 2010, while the fireworks display is in progress. This safety zone should have a minimal impact on transiting vessels because mariners are not precluded from using any portion of the waterway except the area within the safety zone.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Due to the need for immediate action, the restriction of vessel traffic is necessary to protect life, property, and the environment during the fireworks event; therefore, a 30-day notice is impracticable. Delaying the effective date would be contrary to the safety zone's intended objectives of protecting persons and vessels involved in the event, and enhancing public and maritime safety.

On July 4, 2010, the Cape Charles Fire Department will sponsor a fireworks display on the shoreline of the navigable waters of Cape Charles City Harbor centered on position 37°15′59″ N/076°01′12″ W (NAD 1983). Due to the need to protect mariners and spectators from the hazards associated with the fireworks display, such as the accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris, vessel traffic will be temporarily restricted within 420 feet of the fireworks launch site.

The Coast Guard is establishing a safety zone on the navigable waters of the Cape Charles City Harbor within the area bounded by a 420-foot radius circle centered on position 37°15′59″ N/076°01′12″ W (NAD 1983). This safety zone will be established in the vicinity of Cape Charles, VA, from 8 p.m. to 10 p.m. on July 4, 2010. In the interest of public safety, general navigation within the safety zone will be restricted during the specified date and times. Except for participants and vessels authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order. The Office of Management and Budget has not reviewed it under that Order. Although this regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) the zone is of limited size; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit the specified portion of the Cape Charles City Harbor from 8 p.m. to 10 p.m. on July 4, 2010. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: (1) This rule will be enforced for only two hours on July 4, 2010; (2) vessel traffic will be able to navigate safely around the zone without significant impact to their transit plans; and (3) before the effective period begins, we will issue maritime advisories.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction. This rule involves establishing a safety zone around a fireworks display and is expected to have no impact on the water or environment. This zone is designed to protect mariners and spectators from the hazards associated with aerial fireworks displays. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the permit application was not received in time to publish an NPRM followed by a final rule before the effective date and immediate action is necessary to prevent possible loss of life or property due to the potential hazards associated with the sea plane competition.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying this rule would be contrary to the public interest of ensuring the safety of spectators and vessels during this event and immediate action is necessary to prevent possible loss of life or property.

This temporary safety zone is necessary to ensure the safety of vessels and spectators from hazards associated with sea planes taking-off, flying and landing in the area. The Captain of the Port Sault Sainte Marie has determined an aircraft competition with sea planes flying and landing in close proximity to watercraft pose significant risk to public safety and property. The likely combination of large numbers of recreation vessels, congested waterways, alcohol use, and debris falling from the sky into the water presents a significant risk of serious injuries or fatalities. Establishing a safety zone to control vessel movement around the location of the competition and landing area will help ensure the safety of persons and property at these events and help minimize the associated risks.

A temporary safety zone is necessary to ensure the safety of spectators and vessels during the performance of flight maneuvers and water landings in conjunction with the Grand Marias Splash In. This event will occur between 2 p.m. and 5 p.m. on June 19, 2010.

The safety zone for the Grand Marais Splash-In will encompass the southern portion of West Bay. The zone will be bound to the north by a line beginning 100 feet south-southeast of the Lake Street Boat Launch, extending 5280 feet to the east on a true bearing of 080 degrees. The eastern boundary will then be formed by a line drawn to the shoreline on a true bearing of 170 degrees. The western and southern boundaries of the zone will be bound by the shoreline of West Bay. The zone is bound by the coordinates 46°40′22.98″ N/ 085°59′00.78″ W, 46°40′32.04″ N 085°57′46.14″ W and 46°40′19.68″ N 085°57′43.08″ W [DATUM: NAD 83], with the West Bay shoreline forming the South and West boundaries of the zone.

All persons and vessels shall comply with the instructions of the Coast Guard Captain of the Port or the designated on-scene representative. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Sector Sault Sainte Marie, or his on-scene representative. The Captain of the Port or his on-scene representative may be contacted via VHF Channel 16.

We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on 13 of these statutes or executive orders.

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

This determination is based on the minimal time of three hours that vessels will be restricted from the zone. The Coast Guard expects insignificant adverse impact to mariners from the zones' activation.

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

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

This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels intending to transit or anchor in a portion of Lake Superior off Grand Marais, Michigan between 2 p.m. and 5 p.m. on June 19, 2010.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: this rule will be in effect for three hours on one day, and the majority of marinas, piers and wharfs in the area are located on the northern shoreline of West Bay. The Safety Zone will allow vessels to move freely between these areas and Lake Superior. In the event that this temporary safety zone affects shipping, commercial vessels may request permission from the Captain of the Port Sault Sainte Marie to transit through the safety zone. The Coast Guard will give notice to the public via a Broadcast Notice to Mariners that the regulation is in effect.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small entities in understanding the rule so that they can better evaluate its effects on them and participate in the rulemaking process.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

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

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(g), of the Instruction because this rule involves the establishment of a temporary safety zone. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

On December 31, 2009, VA published a proposed rule in the Federal Register (74 FR 69304) to amend regulations in 38 CFR part 39 governing grants to States for Establishment, Expansion, and Improvement Projects and to implement through regulation new statutory authority to provide grants for Operation and Maintenance Projects, as authorized by the Act (Pub. L. 110-157), enacted on December 26, 2007. VA provided a 60-day comment period for the proposed rule that ended March 1, 2010. We received no comments. Based on the rationale set forth in the proposed rule, we are adopting the provisions of the proposed rule as a final rule with the following changes.

We made a non-substantive change to proposed §§ 39.35 and 39.85, so that those regulations refer to a Memorandum of Agreement, rather than a Notification of Award, to be consistent with the title of the corresponding VA Form 40-0895-11.

Also, although we proposed to update references to the architectural design codes that apply to grant applicants, we decided to update those references in a separate rulemaking. Therefore, we removed the references to the updated editions of the various codes in proposed § 39.63 and replaced them with references to the 2002 and 2003 editions of the codes, as appropriate, that were previously incorporated by reference into 38 CFR part 39. Similarly, we removed the references to the International Mechanical Code and International Plumbing Code in proposed § 39.63 and replaced them with references to the Uniform Mechanical Code and Uniform Plumbing Code, respectively, which were previously incorporated by reference into 38 CFR part 39. We did the same with an address from which copies of those two codes can be obtained. Therefore, the editions of codes that were previously incorporated by reference into 38 CFR part 39 will continue to be applicable to grant applicants until the references to the codes are updated or changed through rulemaking.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB), as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities; (2) create a serious inconsistency or interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this final rule have been examined, and it has been determined not to be a significant regulatory action under the Executive Order.

The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. This final rule will directly affect only State government entities and will not directly affect small entities. Therefore, pursuant to 5 U.S.C. 605(b), this final rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This final rule will have no such effect on State, local, or Tribal governments, or on the private sector.

This final rule at §§ 39.31, 39.32, 39.34, 39.81, 39.82, 39.84, 39.120, and 39.122 contains new collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). On December 31, 2009, in proposed rule published in the Federal Register, we requested public comments on the new collections of information. We received no comments. OMB has approved the additional collections in part 39 under OMB Control Number 2900-0559. We are adding a parenthetical statement after the authority citations to all of the sections in part 39 for which new collections have been approved so that the control number is displayed for each new collection.

The Catalog of Federal Domestic Assistance program number and title for this final rule is 64.203, State Cemetery Grants.

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, approved this document on June 7, 2010, for publication.

Issue 36 of the International Mail Manual was issued on May 11, 2009. It replaced all previous editions. Issue 36 of the IMM continues to serve the objectives of the Postal Service's Transformation Plans, the 2004-2008 Five-Year Strategic Plan, the Strategic Transformation Plan 2006-2010, and Vision 2013, Plan for 2009-2013 to enable the Postal Service to fulfill its long-standing mission of providing affordable, universal mail service. The Plans' key strategies include improving operational efficiency, supporting growth through added value to customers, and enhancing the Postal Service's performance-based culture.

In addition, Issue 36 sets forth specific changes such as: new mailing standards for authorized shipments of small packets to Cuba to align USPS® with U.S. Department of Commerce regulations; to expand the use of Priority Mail International® Flat Rate Envelopes and Boxes to Ascension and the Falkland Islands; reorganization of sections 260, 290, and 310 to clarify eligibility for M-bags; and, to codify the Postal Service Sure Money® (DineroSeguro®) service as one of its international money transfer services. Issue 36 also corrects various printing and format errors and omissions in the previous Issue.

The International Mail Manual is available to the public on a subscription basis only from: U.S. Government Printing Office, P.O. Box 979050, St. Louis, MO 63197-9000. The subscription price for one issue is currently $50 to addresses in the United States, and $70 to all foreign addresses. The IMM is also published and available to all users on the Internet at http://pe.usps.com.

I. What acronyms and abbreviations are used in this document? II. How does the Significant New Alternatives Policy (SNAP) program work? A. What are the statutory requirements and authority for the SNAP program? B. What are EPA's regulations implementing Section 612? C. How do the regulations for the SNAP program work? III. How does today's SNAP listing relate to the HCFC phaseout? A. Why is EPA issuing a SNAP listing of alternatives to hydrochlorofluorocarbon (HCFC)-22, HCFC-142b, and blends thereof? B. What happened during the most recent milestone in the HCFC phaseout? C. How does today's SNAP listing affect alternatives to HCFCs other than HCFC-22, HCFC-142b, and blends thereof? D. In servicing existing refrigeration or air-conditioning equipment, may I continue to use refrigerants, previously found acceptable by SNAP, that contain HCFC-22, HCFC-142b, and blends thereof? IV. What are my existing and new options for alternative refrigerants? V. What are my existing and new options for alternative foam blowing agents? VI. What are my existing and new options for alternative aerosol propellants? VII. What are my existing and new options for alternative sterilants? I. What acronyms and abbreviations are used in this document?

Below is a list of acronyms and abbreviations used in this document.

Section 612 of the Clean Air Act (CAA) requires EPA to develop a program for evaluating alternatives to ozone-depleting substances (ODS). EPA refers to this program as the SNAP program. The major provisions of Section 612 are:

Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I (e.g., chlorofluorocarbon, halon, carbon tetrachloride, methyl chloroform, methyl bromide, and hydrobromofluorocarbon) or class II (e.g., hydrochlorofluorocarbon) substance with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment, and (2) is currently or potentially available.

Section 612(c) requires EPA to publish a list of the substitutes unacceptable for specific uses and to publish a corresponding list of acceptable alternatives for specific uses. The list of acceptable substitutes is found at http://www.epa.gov/ozone/snap/lists/index.html and the lists of unacceptable substitutes, substitutes acceptable subject to use conditions and substitutes acceptable subject to narrowed use limits are found at 40 CFR part 82 subpart G.

Section 612(d) grants the right to any person to petition EPA to add a substance to, or delete a substance from, the lists published in accordance with section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.

Section 612(e) directs EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.

Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of such substances in key commercial applications.

Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.

On March 18, 1994, EPA published the original rule (59 FR 13044) establishing the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in the major industrial use sectors (40 CFR part 82, subpart G). These major industrial use sectors are: Refrigeration and air-conditioning; foam blowing; solvents cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors comprise the principal industrial sectors that historically consumed the largest volumes of ODS.

Section 612 of the CAA requires EPA to list as acceptable only those substitutes that do not present a significantly greater risk to human health and the environment as compared with other substitutes that are currently or potentially available.

Under the SNAP regulations, anyone who plans to market or produce a substitute to replace a class I or II ODS in one of the eight major industrial use sectors must provide notice to the Agency, including health and safety information on the substitute, at least 90 days before introducing it into interstate commerce. 1 This requirement applies to the person planning to introduce the substitute into interstate commerce, typically chemical manufacturers, but may also include importers, formulators, equipment manufacturers, or end-users  2 when they are responsible for introducing a substitute into commerce.

The Agency has identified four possible decision categories for substitutes: Acceptable; acceptable subject to use conditions; acceptable subject to narrowed use limits; and unacceptable. Use conditions and narrowed use limits are both considered “use restrictions” and are explained below. Substitutes that are deemed acceptable with no use restrictions (no use conditions or narrowed use limits) can be used for all applications within the relevant end-uses within the sector. Substitutes that are acceptable subject to use restrictions may be used only in accordance with those restrictions. It is a violation of the CAA and EPA's regulations to replace an ODS with a substitute listed as unacceptable, except for certain exceptions (e.g., test marketing, research and development) specified by the regulation.

After reviewing a substitute, the Agency may determine that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to minimize risks to human health and the environment. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of section 612 of the CAA and EPA's SNAP regulations.

For some substitutes, the Agency may permit a narrowed range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. The Agency requires a user of a narrowed use substitute to demonstrate that no other acceptable substitutes are available for their specific application by conducting comprehensive studies. EPA describes these substitutes as “acceptable subject to narrowed use limits.” A person using a substitute that is acceptable subject to narrowed use limits in applications and end-uses that are not consistent with the narrowed use limit, are using these substitutes in an unacceptable manner and are in violation of section 612 of the CAA and EPA's SNAP regulations.

The Agency publishes its SNAP program decisions in the Federal Register (FR). EPA first proposes decisions concerning substitutes that are deemed acceptable subject to use restrictions (use conditions and/or narrowed use limits), or for substitutes deemed unacceptable, to allow the public opportunity to comment. After consideration of the public comments, EPA publishes a final decision.

In contrast, EPA publishes decisions that substitutes are acceptable with no restrictions in “notices of acceptability” without first issuing a proposed decision. As described in the rule initially implementing the SNAP program (59 FR 13044), EPA does not believe that notice-and-comment rulemaking procedures are necessary to list alternatives that are acceptable without restrictions because such listings neither impose any sanction nor prevent anyone from using a substitute.

Many SNAP listings include “comments” or “further information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs. The “further information” classification does not necessarily include all other legal obligations pertaining to the use of the substitute. While the items listed are not legally binding under the SNAP program, EPA encourages users of substitutes to apply all statements in the “comments” or “further information” column in their use of these substitutes. In many instances, the information simply refers to sound operating practices that have already been identified in existing industry and/or building-codes or standards. Thus, many of the statements, if adopted, would not require the affected user to make significant changes in existing operating practices.

To date, EPA has listed many HCFCs as acceptable substitutes for class I ODS thus allowing their use as substitutes for CFCs and for halons under SNAP. As production and importation of HCFCs becomes more limited, availability of these substances for use in current end uses may be limited. 3 In addition, EPA's phaseout regulations contain some use restrictions for specific substances. In particular, per the most recent milestone in the HCFC phaseout, as of January 1, 2010, virgin HCFC-22 and HCFC-142b, and blends containing one or both of these compounds, may only be used as refrigerants to service existing equipment (minor exceptions apply: Please see details in B, below).

In previous SNAP notices, EPA has listed a number of acceptable substitutes for HCFC-22, HCFC-142b, and blends containing one or both of these chemical compounds (“blends thereof”). In today's SNAP listing, EPA is providing a comprehensive list of acceptable substitutes for HCFC-22, HCFC-142b, and blends thereof, generally those that have been previously found acceptable as substitutes, as well as HFO-1234ze in several additional end uses. This notice only addresses the refrigeration and air-conditioning, foam blowing, aerosols, and sterilants sectors. Because HCFC-22, HCFC-142b, and blends thereof have not traditionally been used to any significant extent in the fire suppression and explosion protection, solvent cleaning, tobacco expansion, and adhesives, coatings and inks sectors, we are not making listing decisions for substitutes in these sectors in this notice.

Under the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) and the CAA, HCFCs are considered transitional alternatives in the phaseout of CFCs and other class I ODS. HCFCs are less potent ozone depleters than are CFCs and other class I substances; however, they are still subject to both a global and domestic phaseout under the Montreal Protocol and the CAA. HCFCs will no longer be produced in or imported into the United States in accordance with a tiered phaseout that will culminate in the United States in 2030. Under CAA Section 610, the sale and distribution of, or offer for sale and distribution of certain uses of HCFCs in foam blowing and in aerosols or other pressurized dispensers is prohibited. Further, under CAA Section 605(a) and EPA's implementing regulations, use and introduction into interstate commerce (including sale of HCFCs) is or will be prohibited according to the schedule available in the rules cited below and at 40 CFR 82.16, with exceptions for: (1) HCFCs that have been used, recovered, and recycled; (2) HCFCs completely used up in a reaction to create other chemicals; and (3) HCFCs used in refrigeration equipment manufactured before specified dates.

In a December 10, 1993, rule (58 FR 65018), EPA established a `worst-first' approach for the HCFC phaseout; thus the HCFCs with higher ODPs were scheduled for phaseout earlier than those with lower ODPs. That rule announced an accelerated schedule for the phaseout of HCFC-22 and HCFC-142b, such that the production and import of HCFC-22 and HCFC-142b for use in new equipment would be banned as of January 1, 2010. Since 2003 (68 FR 2819), producers or importers of HCFC-22 and HCFC-142b have been required to hold allowances and importers of used HCFCs have been required to obtain prior approval of import on a per shipment basis. In a December 15, 2009, rule (74 FR 66412), EPA reduced the number of HCFC-22 and HCFC-142b allowances to meet and exceed the 2010 reduction step under the Montreal Protocol. That rule also clarified the use ban described in the 1993 rule and generally limited virgin HCFC-22 and HCFC-142b to use as refrigerants in the servicing of existing equipment. It established an exception for the use of HCFC-22 as a refrigerant in newly manufactured equipment where the components were manufactured prior to January 1, 2010, and are specified in a pre-2010 building permit or contract for use on a particular project, as well as temporary exceptions for the use of HCFC-22 in medical equipment and thermostatic expansion valves. For additional information on the HCFC phaseout, please see the rules promulgated on December 10, 1993 (58 FR 65018), January 21, 2003 (68 FR 2819), and December 15, 2009 (74 FR 66412).

This notice does not affect previous SNAP listings of acceptable alternatives to HCFC-141b, which was phased out of production in 2003, nor does it list alternatives to the remainder of HCFCs, such as HCFC-123, HCFC-124, HCFC-225ca, and HCFC-225cb, which will be phased out on a later schedule. EPA anticipates updating the lists of acceptable substitutes under SNAP before the production phaseout of other HCFCs.

We note that EPA recently received a petition concerning the listing of HFC-134a in various end uses. 4 We are still reviewing that petition and nothing in this notice should be construed as prejudging EPA's response to that petition.

HCFC-22, as well as some refrigerant blends containing HCFC-22 and/or HCFC-142b, have previously been found acceptable under SNAP for specified end uses. As noted above, these refrigerant blends, which appear in Table 1, below, may continue to be used in servicing existing equipment, i.e., equipment manufactured before January 1, 2010, in those end uses per the regulations at 40 CFR 82.15(g)(2)(i). (EPA defines the term “manufactured” for appliances at 40 CFR 82.3.)

While HCFC-22 and blends containing HCFC-22 and/or HCFC-142b may currently continue to be used to service existing refrigeration and air-conditioning equipment, EPA reiterates that HCFCs and HCFC blends are not long-term substitutes for ODS. EPA is considering whether current or potential substitutes are available that pose lower risk than these blends.

In the refrigeration and air-conditioning sector, EPA has previously found acceptable HCFC-22 and HCFC blends, including those containing HCFC-22 and HCFC-142b. To aid end users in the refrigeration and air-conditioning sector as they transition from use of these refrigerants, this section lists, by end use: (1) Refrigerants that EPA previously found acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b; and (2) refrigerants that EPA is newly finding acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. Where possible, refrigerants listed as acceptable in the refrigeration and air-conditioning section are identified by their designation per American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 34.

At the end of the decision for each end use, there is narrative comparing environmental, flammability, and toxicity information of the newly acceptable alternatives with other currently or potentially available alternatives. Flammable refrigerants are hazardous waste and must be disposed of consistent with regulations under the Resource Conservation and Recovery Act (RCRA). More environmental and health information is also available in the original SNAP rule of March 18, 1994, the notice of acceptability in which each substitute was first listed, or the sector table, which provides identification information, environmental information, flammability information, and toxicity and exposure data for each of the acceptable alternatives to HCFC-22 and blends containing HCFC-22 and/or HCFC-142b, in the refrigeration and air-conditioning sector. The sector table is available at http://www.epa.gov/ozone/snap/refrigerants/index.html .

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in household and light commercial air-conditioning and heat pumps:

• R-404A (new and retrofit equipment)

• R-407A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in household and light commercial air-conditioning and heat pumps:

• Ammonia absorption system (new equipment)

• Desiccant cooling (new equipment)

• Evaporative cooling (new equipment)

• HFC-134a (new equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22)  5 (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-437A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

Comparison to other refrigerants in the household and light commercial air-conditioning and heat pumps end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section A.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have 100-year integrated (100-yr) global warming potentials (GWPs)  6 relative to CO 2 ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407A is about 2110, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as hazardous air pollutants (HAPs) under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered volatile organic compounds (VOCs) under CAA regulations ( see 40 CFR 51.100(s)) addressing the development of state implementation plans (SIPs) to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.A.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources. 7

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that flammability risks posed by ammonia can be addressed by existing standards from the Occupational Safety and Health Administration (OSHA) and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8-hours, such as Workplace Environmental Exposure Limits (WEELs) from the American Industrial Hygiene Association (AIHA) or Threshold Limit Values (TLVs) from the American Conference of Government Industrial Hygienists (ACGIH). Ammonia has a Permissible Exposure Limit (PEL) of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the Material Safety Data Sheets (MSDSs) and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.A.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the household and light commercial air-conditioning and heat pumps end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in residential dehumidifiers:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in residential dehumidifiers:

• HFC-134a (new and retrofit equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5%by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-421A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-437A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

Comparison to other refrigerants in the residential dehumidifiers end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section B.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations ( see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.B.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.B.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the residential dehumidifiers end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in reciprocating and screw chillers:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in reciprocating and screw chillers:

• Ammonia absorption chillers or vapor compression with secondary loop (new equipment)

• Desiccant cooling (new equipment)

• Evaporative cooling (new equipment)

• HFC-134a (new and retrofit equipment)

• HFC-227ea (new equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

• Stirling cycle (new equipment)

Comparison to other refrigerants in the reciprocating and screw chillers end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section C.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations ( see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.C.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.C.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the reciprocating and screw chillers end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in centrifugal chillers:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in centrifugal chillers:

• Ammonia absorption chillers or vapor compression with secondary loop (new equipment)

• Desiccant cooling (new equipment)

• Evaporative cooling (new equipment)

• HFC-134a (new and retrofit equipment)

• HFC-227ea (new equipment)

• HFC-245fa (new and retrofit equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-423A (ISCEON 39TC) (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• Stirling cycle (new equipment)

• Water/lithium bromide (new equipment)

Comparison to other refrigerants in the centrifugal chillers end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section D.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.D.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8-hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. HFC-245fa exhibits moderate to low toxicity and has an 8-hour WEEL of 300 ppm. Water/lithium bromide absorption exhibits low toxicity. Lithium bromide (LiBr) has a 24-hour/day, 90 day Continuous Exposure Guidance Level (CEGL) value of 1 mg/m 3 from the National Research Council (NRC). Based on this CEGL, EPA recommends an 8-hour preliminary workplace exposure limit of 3 mg/m 3 . 8 EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs and CEGL) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry. Therefore, we find the newly listed substitutes (in IV.D.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the centrifugal chillers end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in industrial process air-conditioning:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in industrial process air-conditioning:

• Ammonia vapor compression or absorption systems (new equipment)

• Desiccant cooling (new equipment)

• Evaporative cooling (new equipment)

• HFC-134a (new and retrofit equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-423A (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

Comparison to other refrigerants in the industrial process air-conditioning end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section E.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.E.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8-hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.E.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the industrial process air-conditioning end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in industrial process refrigeration:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in industrial process refrigeration:

• Ammonia vapor compression or absorption-systems (new equipment)

• Desiccant cooling (new equipment)

• Evaporative cooling (new equipment)

• HC Blend A (OZ-12) (new and retrofit equipment)

• HC Blend B (original formulation of HC-12a) (new and retrofit equipment)

• HFC-134a (new and retrofit equipment)

• HFC-227ea (new equipment)

• HFE-7000  9 (new and retrofit equipment)

• HFE-7100  10 and HFE-7200  11 as secondary heat transfer fluid in not-in-kind systems (new equipment)

• Nitrogen direct gas expansion (new equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-290 (Propane) (new and retrofit equipment)

• R-407A and R-407B (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-423A (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-428A (new equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• R-600 (Butane) (new and retrofit equipment)

• R-744 (Carbon dioxide, CO 2 ) (new equipment)

• R-1270 (Propylene) (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• Stirling cycle (new equipment)

Comparison to other refrigerants in the industrial process refrigeration end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section F.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3610, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. The hydrocarbon substitutes that we are finding acceptable are at the low end of this range. Specifically, R-290, R-600, R-1270, and HC Blends A and B each have a GWP of about 5 or less. This in contrast with the GWPs of the previously listed substitutes, including the GWP of R-404A which is about 3920, the GWP of R-407C which is about 1770, the GWP of R-410A which is about 2090, the GWP of R-422A which is about 3140, and the GWP of R-507A which is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. The hydrocarbons R-290, R-600, and R-1270, as well as all components of HC Blends A and B, are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under these regulations. In comparison, one of the substitutes previously found acceptable in IV.F.1, above, (R-422A) contains a VOC component. Emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

Ammonia has an ASHRAE class 2 flammability classification or moderate flammability risk. EPA believes that the moderate flammability risks of ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry. Each of the newly listed hydrocarbons and hydrocarbon blends has an ASHRAE class 3 flammability classification. As early as the 1994 original SNAP rule, EPA noted that hydrocarbons were used in industrial process refrigeration, including specialized industrial applications such as oil refineries and chemical plants. EPA noted that these users were familiar with hydrocarbons, had safety procedures in place, and that their facilities were designed to comply with the safety standards required for managing flammable chemicals.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low when used according to standard practices for industrial processes and for industrial process refrigeration. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. HFE-7200 has an 8-hour manufacturer acceptable exposure limit (AEL) of 200 ppm and HFE-7000 has an 8-hour manufacturer AEL of 75 ppm. Within the industrial process refrigeration end use, such as at chemical or other industrial plants, proper exposure controls and ventilation are generally available as well as established protocols for handling potentially hazardous materials, and therefore overall occupational risk is mitigated. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs, and manufacturer AELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.F.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the industrial process refrigeration end use.

The bus and passenger train air-conditioning end use previously had substitutes listed as acceptable for HCFC-22 itself, but not as substitutes for blends containing HCFC-22 and/or HCFC-142b; this is reflected in category (1), below.

1. EPA previously found the following acceptable as substitutes for HCFC-22 in bus and passenger train air-conditioning:

• HFC-134a (new and retrofit equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-417A (new and retrofit equipment)

• R-422B and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in bus and passenger train air-conditioning:

• Evaporative cooling (new equipment)

• HFC-134a (new and retrofit equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-417A (new and retrofit equipment)

• R-422B and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

• Stirling cycle (new equipment)

Comparison to other refrigerants in the bus and passenger train air-conditioning end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section G.1 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3250, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920 and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

None of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. For each of these substitutes, EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.G.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the bus and passenger train air-conditioning end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in ice skating rinks:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in ice skating rinks:

• Ammonia vapor compression or absorption systems (new equipment)

• HFC-134a (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-407A and R-407B (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-423A (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-428A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

Comparison to other refrigerants in the ice skating rinks end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section H.2 are non-ozone depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3610, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-422A is about 3140. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations ( see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. In comparison, one of the substitutes previously found acceptable in IV.H.1, above, (R-422A) contains a VOC component. Emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry. Therefore, we find the newly listed substitutes (in IV.H.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the ice skating rinks end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in cold storage warehouses:

• R-404A (new and retrofit equipment)

• R-407A and R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

• R-428A (new and retrofit equipment)

• R-507A (new and retrofit equipment)

• R-744 (Carbon dioxide, CO 2 ) (new equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in cold storage warehouses:

• Ammonia vapor compression or absorption systems (new equipment)

• Desiccant cooling (new equipment)

• Evaporative cooling (new equipment)

• HFC-134a (new and retrofit equipment)

• HFC-227ea (new equipment)

• Pressure stepdown (new equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-407B (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-423A (ISCEON 39TC) (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• Self-chilling cans containing recycled CO 2 (not generating CO 2 via chemical reaction) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

• Stirling cycle

Comparison to other refrigerants in the cold storage warehouses end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section I.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, the GWP of R-422A is about 3140, the GWP of R-428A is about 3610, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. In comparison, two of the substitutes previously found acceptable in IV.I.1, above, (R-422A and R-428A) contain some VOC components. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. For each of these substitutes, EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry. Therefore, we find the newly listed substitutes (in IV.I.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the cold storage warehouse end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in refrigerated transport:

• R-404A (new and retrofit equipment)

• R-407A and R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-428A (new and retrofit equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in refrigerated transport:

• Cryogenic system using recaptured liquid CO 2 or liquid nitrogen (new equipment)

• Direct nitrogen expansion (new equipment)

• HFC-134a (new and retrofit equipment)

• R-125/134a/600a (28.1%/70.0%/1.9% by weight) (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-407B and R-407D (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

• Stirling cycle (new equipment)

Comparison to other refrigerants in the refrigerated transport end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section J.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407A is about 2110, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, the GWP of R-428A is about 3610, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. In comparison, one of the substitutes previously found acceptable in IV.J.1, above, (R-428A) contains some VOC components. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

None of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. For each of these substitutes, EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry. Therefore, we find the newly listed substitutes (in IV.J.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the refrigerated transport end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in retail food refrigeration:

• R-404A (new and retrofit equipment)

• R-407A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

• R-428A (new and retrofit equipment)

• R-507A (new and retrofit equipment)

• R-744 (Carbon dioxide, CO 2 ) (new equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in retail food refrigeration:

• Ammonia vapor compression with a secondary loop (new equipment)

• HFC-134a (new and retrofit equipment)

• HFE-7100 and HFE-7200 as secondary heat transfer fluid in not-in-kind systems (new equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-407B (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

Comparison to other refrigerants in the retail food refrigeration end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section K.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, the GWP of R-422A is about 3140, the GWP of R-428A is about 3610, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. In comparison, two of the substitutes previously found acceptable in IV.K.1, above, (R-422A and R-428A) contain some VOC components. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. HFE-7200 has an 8-hour manufacturer AEL of 200 ppm. For each of these substitutes, EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs, and manufacturer AEL) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.K.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the retail food refrigeration end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in commercial ice machines:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-428A (new and retrofit equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in commercial ice machines:

• Ammonia vapor compression or absorption-systems (new equipment)

• HFC-134a (new equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-407A and R-407B (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

• Stirling cycle (new equipment)

Comparison to other refrigerants in the commercial ice machines end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section L.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, the GWP of R-428A is about 3610, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. In comparison, one of the substitutes previously found acceptable in IV.L.1, above, (R-428A) contains some VOC components. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.L.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the commercial ice machines end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in household refrigerators and freezers:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-422A (ISCEON 79) (new and retrofit equipment)

• R-428A (new and retrofit equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in household refrigerators and freezers:

• Ammonia absorption systems (new equipment)

• HFC-134a (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-424A (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-427A (retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• RS-44 (2003 formulation) (new and retrofit equipment)

Comparison to other refrigerants in the household refrigerators and freezers end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section M.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, the GWP of R-422A is about 3140, the GWP of R-428A is about 3610, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. In comparison, two of the substitutes previously found acceptable in IV.M.1, above, (R-422A and R-428A) contain some VOC components. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of ammonia, none of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. EPA believes that the flammability risks posed by ammonia can be addressed by existing standards from OSHA and ASHRAE and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. Ammonia has a PEL of 50 ppm over 8 hours from OSHA. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.M.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the household refrigerators and freezers end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in vending machines:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in vending machines:

• HFC-134a (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

• Stirling cycle (new equipment)

Comparison to other refrigerants in the vending machines end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section N.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.N.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

None of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.N.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the vending machines end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in water coolers:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

• R-507A (new and retrofit equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in water coolers:

• HFC-134a (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-410B (new equipment)

• R-417A (new and retrofit equipment)

• R-421A and R-421B (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-426A (new and retrofit equipment)

• R-434A (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• RS-24 (2002 formulation) (new and retrofit equipment)

• SP34E (new and retrofit equipment)

Comparison to other refrigerants in the water coolers end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section O.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, the GWP of R-410A is about 2090, and the GWP of R-507A is about 3990. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.O.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

None of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, and PELs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.O.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the vending machines end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in very low temperature refrigeration:

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in very low temperature refrigeration:

• HFE-7100 and HFE-7200 as secondary heat transfer fluid in not-in-kind systems (new equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-422B and R-422C (new and retrofit equipment)

• R-744 (Carbon dioxide, CO 2 ) (new equipment)

Comparison to other refrigerants in the very low temperature refrigeration end use:

The newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b listed above in section P.2 are non-ozone-depleting, in contrast to HCFC-22 or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, and the GWP of R-410A is about 2090. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. None of the substitutes previously found acceptable in IV.P.1, above, contain VOCs. However, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

None of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b is flammable. The toxicity risks of the newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b are low. Most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. HFE-7200 has an 8-hour manufacturer AEL of 200 ppm. R-744 has a PEL of 5000 ppm. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs and AEL) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry.

Therefore, we find the newly listed substitutes (in IV.P.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the vending machines end use.

HFO-1234ze, 12 which was previously listed as a substitute for class I and class II ODS in several foam blowing end uses (September 30, 2009; 74 FR 50129) is today being listed as acceptable as a substitute for CFC-113, HCFC-22, and blends containing HCFC-22 and/or HCFC-142b, in the heat transfer end use. You may find the submission under Docket items EPA-HQ-OAR-2003-0118-0222 and EPA-HQ-OAR-2003-0118-0247 at http://www.regulations.gov. We note that EPA is also reviewing this substance through a Pre-Manufacture Notice (PMN) under the Toxic Substances Control Act (TSCA) and users will be subject under TSCA to any requirements established through the PMN process.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC blends, including those containing HCFC-22 and/or HCFC-142b, in non-mechanical heat transfer systems:

• HFC-4310mee (new and retrofit equipment)

• R-404A (new and retrofit equipment)

• R-407C (new and retrofit equipment)

• R-410A (new equipment)

2. EPA is newly finding the following acceptable as substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b in non-mechanical heat transfer systems:

• C6-perfluoroketone  13 (Novec TM 649) (new and retrofit equipment)

• HFC-245fa (new and retrofit equipment)

• HFE-7000 (new and retrofit equipment)

• HFE-7100 (new and retrofit equipment)

• HFE-7200 (new and retrofit equipment)

• HFO-1234ze (new and retrofit equipment)

• R-125/290/134a/600a (55.0%/1.0%/42.5%/1.5% by weight) (ICOR AT-22) (new and retrofit equipment)

• R-417A (new and retrofit equipment)

• R-422B, R-422C, and R-422D (new and retrofit equipment)

• R-438A (new and retrofit equipment)

• R-744 (Carbon Dioxide, CO 2 ) (new and retrofit equipment)

• Volatile Methyl Siloxanes  14 (new and retrofit equipment)

• Water (new and retrofit equipment)

3. EPA is newly finding the following acceptable as a substitute for CFC-113 in non-mechanical heat transfer systems:

• HFO-1234ze (new and retrofit equipment)

Comparison to other refrigerants in the non-mechanical heat transfer systems end use:

The newly listed substitutes for CFC-113, HCFC-22, and blends containing HCFC-22 and/or HCFC-142b listed above in section P.2 and 3 are non-ozone-depleting, in contrast to CFC-113, HCFC-22, or blends containing HCFC-22 and/or HCFC-142b. They are comparable to other acceptable substitutes for CFC-113, HCFC-22, and blends containing HCFC-22 and/or HCFC-142b in their lack of risk for ozone depletion. HFO-1234ze has no ODP. HFO-1234ze has a GWP of 6 and an atmospheric lifetime of approximately 2 weeks (Javadi et al., 2008). The newly listed substitutes have GWPs ranging from 0 to about 3390, comparable to or lower than that of other substitutes for CFC-113, HCFC-22, and blends containing HCFC-22 and/or HCFC-142b. For example, the GWP of HFC-4310mee is about 1640, the GWP of R-404A is about 3920, the GWP of R-407C is about 1770, and the GWP of R-410A is about 2090. The contribution of these refrigerants to greenhouse gas emissions is limited given the venting prohibition under section 608(c)(2) of the CAA and EPA's implementing regulations codified at 40 CFR 82.154(a)(1), which limit emissions of refrigerant substitutes.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. C6-perfluoroketone and HFO-1234ze are considered VOCs under CAA regulations ( see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. Some of the newly listed substitutes contain small amounts of components that are considered VOCs under those regulations. In comparison, none of the substitutes previously found acceptable in IV.Q.1, above, contain VOCs. EPA has received a petition to exempt HFO-1234ze from the definition of VOC for purposes of SIPs to attain and maintain the NAAQS on the basis that the chemical has a low photochemical reactivity. EPA intends to address the request through notice-and-comment rulemaking. Further, emissions of VOCs from refrigerant blends are expected to be small relative to the total emissions of VOCs from all sources.

With the exception of some of the volatile methyl siloxanes, none of the newly listed substitutes for CFC-113, HCFC-22, and blends containing HCFC-22 and/or HCFC-142b is flammable. Some volatile methyl siloxanes have flammability risks, and EPA believes that these will be addressed by existing standards from OSHA, ASHRAE, guidelines in the MSDSs, and other safety precautions common in the refrigeration and air-conditioning industry.

The toxicity risks of the newly listed substitutes for CFC-113, HCFC-22, and blends containing HCFC-22 and/or HCFC-142b are low. The potential health effects of HFO-1234ze at lower concentrations include drowsiness and dizziness. At sufficiently high concentrations, it may cause central nervous system depression or irregular heartbeat. HFO-1234ze could cause asphyxiation, if air is displaced by vapor in a confined space. The substitute may also irritate the lungs, skin or eyes or cause frostbite. These potential health effects are common to many refrigerants. EPA anticipates that users of non-mechanical heat transfer systems will take action consistent with the recommendations specified in the manufacturers' MSDSs for HFO-1234ze. EPA recommends a workplace AEL of 1,000 ppm on an 8-hour time-weighted average for HFO-1234ze. 15 EPA recommends a preliminary consumer exposure limit (acute) of 10,000 ppm on a 30-minute time-weighted average. Our risk screen found that workplace and consumer exposure, respectively, are likely to be well below these levels. 16

As for the other newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b, most of the blends contain HFC or hydrocarbon components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. C6-perfluoroketone has an 8-hour manufacturer AEL of 150 ppm, HFE-7200 has an 8-hour manufacturer AEL of 200 ppm, and HFE-7000 has an 8-hour manufacturer AEL of 75 ppm. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs, manufacturer AELs and EPA recommendation) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the refrigeration and air-conditioning industry. Therefore, we find the newly listed substitutes (in IV.P.2 and 3, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the non-mechanical heat transfer end use.

Historically, HCFC-22 and HCFC-142b, along with HCFC-141b, have been used as substitutes for CFC-11 and CFC-12 in foam blowing. HCFC-22 and HCFC-142b were originally found acceptable as substitutes for CFCs in all foam blowing end uses under the SNAP program (March 18, 1994; 59 FR 13084). In 2007, EPA found a number of foam blowing agents containing HCFCs unacceptable for use as substitutes for ODS, because alternatives exist with zero or lower ODPs. Specifically, EPA has found HCFC-22, HCFC-142b, and blends thereof unacceptable as substitutes for CFCs in the following end uses:

○ Rigid polyurethane and polyisocyanurate laminated boardstock;

○ Rigid polyurethane appliance;

○ Rigid polyurethane spray and commercial refrigeration, and sandwich panels;

○ Rigid polyurethane slabstock and other foams;

○ Polystyrene extruded insulation boardstock and billet;

○ Phenolic insulation board and bunstock;

○ Flexible polyurethane; and

○ Polystyrene extruded sheet

(40 CFR part 82 appendix Q to subpart G)

EPA has also found HCFC-22, HCFC-142b, and blends thereof unacceptable as substitutes for HCFC-141b in the following end uses:

○ Rigid polyurethane and polyisocyanurate laminated boardstock;

○ Rigid polyurethane appliance;

○ Rigid polyurethane spray and commercial refrigeration, and sandwich panels; and

○ Rigid polyurethane slabstock and other foams

(40 CFR part 82 appendix K to subpart G and 40 CFR part 82 appendix Q to subpart G)

Existing users of HCFC-22, HCFC-142b, and blends thereof, as of November 4, 2005, were allowed a transition period (which varied in time by end use and application) to switch to alternatives, depending on the specific use. The last of these transition periods ended January 1, 2010 (40 CFR part 82 appendix Q to subpart G).Corvette2008

Finally, EPA has found that HCFC-124 is unacceptable as a substitute for HCFC-123, HCFC-141b, HCFC-142b, HCFC-22, or blends thereof in all foam blowing end uses (40 CFR Part 82 Appendix K to Subpart G).

In the original SNAP rulemaking EPA addressed the use of blends in foam blowing applications. EPA determined that notification was not required for “use of blends or mixtures of substitutes listed as acceptable under the SNAP program in open-celled or closed-cell or semi-rigid end uses” but was required in the following end-uses: polyurethane and polyisocyanurate rigid laminated boardstock; polyurethane spray foam; polystyrene extruded boardstock and billet foams; phenolic foams; and polyolefin foams (59 FR 13084, March 18, 1994). Therefore, blends of acceptable substitutes are also acceptable substitutes for the following foam blowing end uses: rigid polyurethane, appliance; rigid polyurethane, commercial (including commercial foam and sandwich panels, but excluding spray foam); rigid polyurethane, slabstock; flexible polyurethane; polystyrene, extruded sheet; and integral skin polyurethane.

To aid end users as they transition from use of HCFC-22 and HCFC-142b, sections IV.A through K list, by end use: (1) Foam blowing agents that EPA previously found acceptable as substitutes for HCFC-22, HCFC-142b, or all HCFCs; and (2) foam blowing agents that EPA is newly finding acceptable as substitutes for HCFC-22, HCFC-142b, or blends thereof. At the end of the decision for each end use, there is narrative comparing environmental, flammability, and toxicity information of the newly acceptable alternatives with other currently or potentially available alternatives. Flammable blowing agents are hazardous waste when disposed and must be disposed of consistent with regulations under RCRA. More environmental information, flammability information, and toxicity and exposure data is also available in the original SNAP rule of March 18, 1994, the notice of acceptability in which each substitute was first listed, or the sector table for each of the acceptable alternatives to HCFC-22, HCFC-142b, and blends thereof, in the foam blowing sector. The sector table is available at http://www.epa.gov/ozone/snap/foams/index.html . The sector table also includes further identification information (including composition and trade names) for each substitute.

Due to the unique flammability concerns that affect listings in the spray foam application, for greater clarity this document separates listings for spray foam (section V.D) from listings for commercial refrigeration foam and sandwich panels (section V.C). Commercial refrigeration foam, spray foam, and sandwich panels together constitute the rigid polyurethane commercial refrigeration foam, spray foam, and sandwich panels end use. However, because of the heightened risk of using a flammable blowing agent when blowing spray foam, in most cases we have not listed flammable substitutes as acceptable in spray foam ( e.g., methyl formate and C3-C6 saturated light hydrocarbons), although we have found some acceptable for use in commercial refrigeration foam and in sandwich panels ( see April 11, 2000; 65 FR 19327, December 18, 2000; 65 FR 78977, August 21, 2003; 68 FR 50533, and September 30, 2009; 74 FR 50129). In limited circumstances, where the submitter of a specific substitute has supplied EPA with a safety training program for customers to address the flammability risks unique to spray foam, we have listed such flammable blowing agents as acceptable for spray foam applications (see December 6, 1999; 64 FR 68039 and October 1, 2004; 69 FR 58903).

HFO-1234ze, 17 which was previously listed as a substitute for class I and class II ODS in several foam blowing end uses (September 30, 2009; 74 FR 50129) is today being listed as a substitute for HCFC-22, HCFC-142b, and blends thereof in five other foam blowing end uses. You may find the submission under Docket items EPA-HQ-OAR-2003-0118-0222 and EPA-HQ-OAR-2003-0118-0246 at http://www.regulations.gov .

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in rigid polyurethane & polyisocyanurate laminated boardstock:

• Carbon dioxide, CO 2

• 2-chloropropane

• Ecomate TM

• Formacel® TI

• Formic acid

• HFC-134a

• HFC-152a

• HFC-245fa

• Methyl formate

• Transcend TM Technologies, as an additive to SNAP-approved blowing agents in blends making up to 5% by weight of the total foam formulation.

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in rigid polyurethane & polyisocyanurate laminated boardstock:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• HFO-1234ze

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the rigid polyurethane & polyisocyanurate laminated boardstock end use:

The newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section A.2 are non-ozone-depleting, in contrast to HCFC-22, HCFC-142b, or blends thereof. They are comparable to other acceptable substitutes for HCFC-22, HCFC-142b, and blends thereof in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to 794, comparable to or lower than that of other substitutes for HCFC-22, HCFC-142b, and blends thereof. For example, the GWP of HFC-134a is about 1430 and the GWP of HFC-245fa is about 1030.

None of the newly listed refrigerant substitutes contain any components that are defined as HAPs under the CAA. C3-C6 saturated hydrocarbons, HFO-1234ze, and some components of Exxsol blowing agents are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. EPA has received a petition to exempt HFO-1234ze from the definition of VOC for purposes of SIPs to attain and maintain the NAAQS on the basis that the chemical has a low photochemical reactivity. EPA intends to address the request through notice-and-comment rulemaking. Of the substitutes previously found acceptable in V.A.1, above, 2-chloropropane and formic acid are VOCs.

Among the newly listed substitutes for HCFC-22, HCFC-142b, or blends thereof, Exxol Blowing Agents, HFC-365mfc, and C3-C6 saturated hydrocarbons are flammable. Examples of other flammable foam blowing agents that we previously found acceptable in this end use include 2-chloropropane, Ecomate TM , formic acid, HFC-152a, and methyl formate. EPA believes that the flammability risks can be addressed by existing standards from OSHA, guidelines from the manufacturer, and other safety precautions common in the foam blowing industry.

The toxicity risks of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof are low. The potential health effects of HFO-1234ze at lower concentrations include drowsiness and dizziness. The substitute may also irritate the lungs, skin or eyes or cause frostbite. At sufficiently high concentrations, it may cause central nervous system depression or irregular heart beat. HFO-1234ze could cause asphyxiation, if air is displaced by vapor in a confined space. These potential health effects are common to many foam blowing agents. EPA anticipates that users in foam blowing end uses will take action consistent with the recommendations specified in the manufacturers' MSDSs for HFO-1234ze. EPA recommends a workplace AEL of 1,000 ppm on an 8-hour time-weighted average for HFO-1234ze, which is updated from our preliminary recommendation that accompanied the acceptability listing for HFO-1234ze in several other foam blowing end uses (74 FR 50129; September 30, 2009). 18 Our risk screen found that workplace exposure is likely to be well below that level. 19

As for the other newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b, HFC-365mfc, C3-C6 saturated light hydrocarbons, and Exxsol blowing agents contain components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from ACGIH. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs and EPA recommendation) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the foam blowing industry. Therefore, we find the newly listed substitutes (in V.A.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the rigid polyurethane & polyisocyanurate laminated boardstock end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in rigid polyurethane appliance foam:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• Formic acid

• HFC-134a

• HFC-152a

• HFC-245fa

• HFO-1234ze

• Methyl formate

• Transcend TM Technologies, as an additive to SNAP-approved blowing agents in blends making up to 5% by weight of the total foam formulation.

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in rigid polyurethane appliance foam:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

• Vacuum panels

Comparison to other foam blowing agents in the rigid polyurethane appliance foam end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.B.2, with the exception of vaccum panels, to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Vacuum panels have an ODP and GWP of 0, are not VOCs or HAPs, are non-flammable, and do not present toxicity concerns. Please see section V.A.2 for further information on the environmental and safety impacts of the newly listed alternatives compared to other available alternatives. For the reasons discussed above in this section and in section V.A.2, we find that the newly listed substitutes (in V.B.2, above) are acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the rigid polyurethane appliance foam end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in rigid polyurethane commercial refrigeration foam and sandwich panels:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• Formic acid

• HFC-134a

• HFC-152a

• HFC-245fa

• HFO-1234ze

• Methyl formate

• Transcend TM Technologies, as an additive to SNAP-approved blowing agents in blends making up to 5% by weight of the total foam formulation.

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in rigid polyurethane commercial refrigeration foam and sandwich panels:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• HFC-365mfc/HFC-245fa blends containing at least 5% HFC-245fa

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the rigid polyurethane commercial refrigeration foam and sandwich panels end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.C.2, with the exception of HFC-365mfc/HFC-245fa blends containing at least 5% HFC-245fa, to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Blends of HFC-365mfc/HFC-245fa containing at least 5% HFC-245fa are comparable to other acceptable substitutes for HCFC-22, HCFC-142b, or blends thereof in the rigid polyurethane commercial refrigeration foam and sandwich panels end use in their lack of risk for ozone depletion. In addition, these blends have average GWPs ranging from 870 to 960, comparable to or lower than other substitutes (e.g., the GWP of HFC-134a is about 1430 and the GWP of HFC-245fa is about 1030). HFC-365mfc and HFC-245fa are exempt from the definition of VOCs under CAA regulations addressing the development of SIPs to attain and maintain the national ambient air quality standards. HFC-365mfc is flammable. Examples of other flammable foam blowing agents that we previously found acceptable in this end use include Ecomate TM , formic acid, HFC-152a, and methyl formate. EPA believes the flammability risks can be addressed by existing standards from OSHA, guidelines from the manufacturer, and other safety precautions common in the foam blowing industry. With regard to toxicity, HFC-245fa has an 8-hour WEEL of 300 ppm. EPA anticipates that users will be able to meet the WEEL and will address potential health risks by following requirements and recommendations in the MSDS and other safety precautions common in the foam blowing industry. Please see section V.A.2 for further information on the environmental and safety impacts of the other newly listed alternatives compared to available alternatives.

For the reasons discussed above in this section and in section V.A.2, we find the newly listed substitutes (in V.C.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the rigid polyurethane commercial refrigeration foam and sandwich panels end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in rigid polyurethane spray foam:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• Formic acid

• HFC-134a

• HFC-152a

• HFC-245fa

• HFO-1234ze

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in rigid polyurethane spray foam:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc/HFC-245fa blends containing at least 5% HFC-245fa

Comparison to other foam blowing agents in the rigid polyurethane spray foam end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.D.2 to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Please see section V.A.2 for further information on the environmental and safety impacts of the newly listed alternatives compared to available alternatives. For the reasons above in this section and in section V.A.2, we find the newly listed substitutes (in V.D.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the rigid polyurethane spray foam end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in rigid polyurethane slabstock and other foams:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• Formic acid

• HFC-134a

• HFC-152a

• HFC-245fa

• Methyl formate

• Transcend TM Technologies, as an additive to SNAP-approved blowing agents in blends making up to 5% by weight of the total foam formulation.

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in rigid polyurethane slabstock and other foams:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• HFO-1234ze

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the rigid polyurethane slabstock and other foams end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.E.2 to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Please see section V.A.2 for further information on the environmental and safety impacts of the newly listed alternatives compared to available alternatives. For the reasons above and in V.A.2, we find the newly listed substitutes (in V.E.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the rigid polyurethane, slabstock and other foam end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in polystyrene extruded boardstock and billet:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® B

• Formacel® TI

• HFC-134a

• HFC-152a

• HFC-245fa

• HFO-1234ze

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in polystyrene extruded boardstock and billet:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the polystyrene extruded boardstock and billet end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.F.2 to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Please see section V.A.2 for further information on the environmental and safety impacts of the newly listed alternatives compared to available alternatives. For the reasons above and in section V.A.2, we find the newly listed substitutes (in V.F.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the polystyrene, extruded boardstock and billet end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in phenolic insulation board and bunstock:

• Carbon dioxide, CO 2

• Ecomate TM

• HFC-134a

• HFC-152a

• HFC-245fa

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in phenolic insulation board and bunstock:

• 2-chloropropane

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• HFO-1234ze

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the phenolic insulation board and bunstock end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.G.2, with the exception of 2-chloropropane, to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. 2-chloropropane is comparable to other acceptable substitutes for HCFC-22, HCFC-142b, and blends thereof in the phenolic insulation board and bunstock end use in its lack of risk for ozone depletion. Additionally, we estimate it has a GWP of 5 or less, comparable to or lower than that of other substitutes for HCFC-22, HCFC-142b, and blends thereof (e.g., the GWP of HFC-134a is about 1430, the GWP of HFC-245fa is about 1030, and the GWP of carbon dioxide is 1). 2-chloropropane is considered a VOC under CAA regulations addressing the development of SIPs to attain and maintain the national ambient air quality standards. 2-chloropropane is flammable, like the newly listed substitutes for HCFC-22, HCFC-142b, or blends thereof, Exxol Blowing Agents, HFC-365mfc, and C3-C6 saturated hydrocarbons. Examples of other flammable foam blowing agents that we previously found acceptable in this end use include Ecomate TM , HFC-152a, and methyl formate. EPA believes the flammability risks can be addressed by existing standards from OSHA, guidelines from the manufacturer, and other safety precautions common in the foam blowing industry. With regard to toxicity, EPA recommends a workplace exposure limit of 350 ppm on an 8-hour time-weighted average for 2-chloropropane (65 FR 37900, June 19, 2000). EPA anticipates users will be able to meet the recommended workplace exposure limit and will address potential health risks by following requirements and recommendations in the MSDS and other safety precautions common in the foam blowing industry. Please see section V.A.2 for further information on the environmental and safety impacts of the other newly listed alternatives compared to available alternatives. For the reasons above and in section V.A.2, we find the newly listed substitutes (in V.G.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the phenolic insulation board & bunstock end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in polystyrene, extruded sheet:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• HFC-134a

• HFC-152a

• HFC-245fa

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in polystyrene, extruded sheet:

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the polystyrene, extruded sheet end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.H.2 to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Please see section V.A.2 for further information on the environmental and safety impacts of the newly listed alternatives compared to available alternatives. For the reasons above and in section V.A.2, we find the newly listed substitutes (in V.H.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the polystyrene, extruded sheet end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in flexible polyurethane:

• Carbon dioxide, CO 2

• Ecomate TM

• HFC-134a

• HFC-152a

• HFC-245fa

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in flexible polyurethane:

• Acetone

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the flexible polyurethane end use:

We are finding all of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.I.2, with the exception of acetone, to also be acceptable in the rigid polyurethane and polyisocyanurate laminated boardstock end use. Acetone is comparable to other acceptable substitutes for HCFC-22, HCFC-142b, and blends thereof in its lack of risk for ozone depletion. Acetone has a GWP of 0.5, comparable to or lower than that of other substitutes for HCFC-22, HCFC-142b, and blends thereof (e.g., the GWP of HFC-134a is about 1430, the GWP of HFC-245fa is about 1030, and the GWP of carbon dioxide is 1). Acetone is exempt from the definition of VOC under CAA regulations addressing the development of SIPs to attain and maintain the national ambient air quality standards. Acetone is flammable, along with other substitutes for HCFC-22, HCFC-142b, or blends thereof, including Exxol Blowing Agents, HFC-365mfc, and C3-C6 saturated hydrocarbons. Examples of other flammable foam blowing agents that we previously found acceptable in this end use include Ecomate TM and HFC-152a. EPA believes that the flammability risks can be addressed by existing standards from OSHA, guidelines from the manufacturer, and other safety precautions common in the foam blowing industry. With regard to toxicity, acetone has an 8-hour ACGIH TLV of 500 ppm. EPA anticipates that users will be able to meet the TLV and will address potential health risks by following requirements and recommendations in the MSDS and other safety precautions common in the foam blowing industry. Please see section V.A.2 for further information on the environmental and safety impacts of the other newly listed alternatives compared to available alternatives. For the reasons above and in section V.A.2, we find the newly listed substitutes (in V.I.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the flexible polyurethane end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in polyolefin:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• HFC-134a

• HFC-152a

• HFC-245fa

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in polyolefin:

• Blends of HFC-152a and saturated light hydrocarbons (C3-C6)

• Chemical Blend A  20

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• HFO-1234ze

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the polyolefin end use:

The newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.J.2 are non-ozone-depleting, in contrast to HCFC-22, HCFC-142b, or blends thereof. They are comparable to other acceptable substitutes for HCFC-22, HCFC-142b, and blends thereof in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to 790, comparable to or lower than that of other substitutes for HCFC-22, HCFC-142b, and blends thereof. For example, the GWP of HFC-134a is about 1430 and the GWP of HFC-245fa is about 1030.

HFO-1234ze is currently considered a VOC, and Exxsol blowing agents and C3-C6 saturated hydrocarbons contain compounds that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. EPA has received a petition to exempt HFO-1234ze from the definition of VOC for purposes of SIPs to attain and maintain the NAAQS on the basis that the chemical has a low photochemical reactivity. EPA intends to address the request through notice-and-comment rulemaking. None of the acceptable substitutes previously listed in this end use are VOCs. However, HFO-1234ze, Exxsol blowing agents, and C3-C6 saturated hydrocarbons have lower overall environmental and health risk compared to other substitutes.

Among the newly listed substitutes for HCFC-22, HCFC-142b, or blends thereof, Exxol Blowing Agents, HFC-365mfc, and C3-C6 saturated hydrocarbons are flammable. Examples of other flammable foam blowing agents that we previously found acceptable in this end use include Ecomate  TM and HFC-152a. EPA believes the flammability risks can be addressed by following existing standards from OSHA, guidelines from the manufacturer, and other safety precautions common in the foam blowing industry.

The toxicity risks of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof are low. The potential health effects of HFO-1234ze at lower concentrations include drowsiness and dizziness. The substitute may also irritate the skin or eyes or cause frostbite. At sufficiently high concentrations, it may cause central nervous system depression or irregular heart beat. HFO-1234ze could cause asphyxiation, if air is displaced by vapor in a confined space. The substitute may also irritate the lungs, skin or eyes or cause frostbite. These potential health effects are common to many foam blowing agents. EPA anticipates that users in foam blowing end uses will take action consistent with the recommendations specified in the manufacturers' MSDSs for HFO-1234ze. EPA recommends a workplace AEL of 1,000 ppm on an 8-hour time-weighted average for HFO-1234ze, which is updated from our preliminary recommendation that accompanied the acceptability listing for HFO-1234ze in several other foam blowing end uses (74 FR 50129; September 30, 2009). Our risk screen found that workplace exposure is likely to be well below that level. 21

As for the other newly listed substitutes for HCFC-22 and blends containing HCFC-22 and/or HCFC-142b, HFC-365mfc, C3-C6 saturated light hydrocarbons and Exxsol blowing agents contain components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or TLVs from the ACGIH. EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs, manufacturer's recommendation, and EPA recommendation) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the foam blowing industry. For the above reasons, we find the newly listed substitutes (in V.J.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the polyolefin end use.

1. EPA previously found the following acceptable as substitutes for HCFC-22, HCFC-142b, blends thereof, or for all HCFCs in integral skin polyurethane:

• Carbon dioxide, CO 2

• Ecomate TM

• Formacel® TI

• Formic acid

• HFC-134a

• HFC-152a

• HFC-245fa

• Methyl formate

• Water

2. EPA is newly finding the following acceptable as substitutes for HCFC-22, HCFC-142b, and blends thereof in integral skin polyurethane:

• Acetone

• Electroset technology

• Exxsol blowing agents

• HFC-365mfc

• HFO-1234ze

• Saturated light hydrocarbons C3-C6 (e.g., propane, butane, isobutane, pentane, cyclopentane, hexane, cyclohexane)

Comparison to other foam blowing agents in the integral skin polyurethane end use:

The newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section V.K.2 are non-ozone-depleting, in contrast to HCFC-22, HCFC-142b, or blends thereof. They are comparable to other acceptable substitutes for HCFC-22, HCFC-142b, and blends thereof in their lack of risk for ozone depletion. The newly listed substitutes have GWPs ranging from 0 to 794, comparable to or lower than that of other substitutes for HCFC-22, HCFC-142b, and blends thereof. For example, the GWP of HFC-134a is about 1430 and the GWP of HFC-245fa is about 1030.

HFO-1234ze is currently considered a VOC, and Exxsol blowing agents and C3-C6 saturated hydrocarbons contain compounds that are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. EPA has received a petition to exempt HFO-1234ze from the definition of VOC for purposes of SIPs to attain and maintain the NAAQS on the basis that the chemical has a low photochemical reactivity. EPA intends to address the request through notice-and-comment rulemaking. An acceptable substitute previously listed in this end use that is a VOC is formic acid.

Among the newly listed substitutes for HCFC-22, HCFC-142b, or blends thereof, acetone, Exxol Blowing Agents, HFC-365mfc, and C3-C6 saturated hydrocarbons are flammable. Examples of other flammable foam blowing agents that we previously found acceptable in this end use include Ecomate TM , formic acid, and HFC-152a. EPA believes that the flammability risks can be addressed by existing standards from the OSHA, guidelines from the manufacturer, and other safety precautions common in the foam blowing industry.

The toxicity risks of the newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof are low. HFC-365mfc, C3-C6 saturated light hydrocarbons and Exxsol blowing agents contain components with workplace exposure limits of 500 to 1,000 ppm averaged over 8 hours, such as WEELs from the AIHA or threshold limit values (TLVs) from the ACGIH. EPA recommends a workplace AEL of 1000  22 ppm on an 8-hour time-weighted average for HFO-1234ze, which is updated from our preliminary recommendation that accompanied the acceptability listing for HFO-1234ze in several other foam blowing end uses (74 FR 50129, September 30, 2009). EPA anticipates that users will be able to meet the workplace exposure limits (WEELs, TLVs, PELs and EPA recommendation) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common in the foam blowing industry. For the above reasons, we find the newly listed substitutes (in V.K.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the integral skin polyurethane end use.

We previously found HCFC-22 and HCFC-142b acceptable as substitutes for CFC-11 in the aerosol propellant end use. In the aerosol propellants end use, the two HCFCs typically have not been blended.

Under the Nonessential Products Ban in Section 610 of the CAA, and EPA's regulations implementing that provision at 40 CFR subpart C, the sale and distribution or offer for sale and distribution of HCFCs in pressurized containers is banned. However, EPA regulations at 40 CFR 82.70 provide exceptions for a limited number of specific uses. For aerosol propellants, these include:

• Medical devices listed in 21 CFR 2.125(e);

• Mold release agents that contain HCFC-22 as a propellant where evidence of good faith efforts to secure alternatives indicates that, other than a class I substance, there are no suitable alternatives;

• Spinnerette lubricants/cleaning sprays used in the production of synthetic fibers, which contain class II substances for solvent purposes and/or contain class II substances for propellant purposes;

• Document preservation sprays which contain HCFC-22 as a propellant, but which contain no other class II substance and which are used solely on thick books, books with coated, dense or paper and tightly bound documents;

• Aerosol or pressurized dispenser cleaning fluid for electronic and photographic equipment which contains a class II substance that is sold or distributed to a commercial purchaser.

To aid end users in the aerosol propellants end use as they transition from use of HCFC-22, HCFC-142b, and blends thereof, this section lists: 1) Propellants that EPA previously found acceptable as substitutes for HCFC-22 and HCFC-142b; and 2) a propellant that EPA is newly finding acceptable as a substitute for CFC-11, HCFC-22, HCFC-142b, and blends thereof. At the end of the decision for the end use, there is narrative comparing environmental, flammability, and toxicity information of the newly acceptable alternative with other currently or potentially available alternatives. More environmental and health information is also available in the original SNAP rule of March 18, 1994, the notice of acceptability in which each substitute was first listed, or the sector table for each of the acceptable alternatives to HCFC-22, HCFC-142b, and blends thereof, in the aerosol propellants end use. The sector table is available at http://www.epa.gov/ozone/snap/aerosol/index.html . The sector table also includes further identification information (including composition and trade names) for each substitute.

1. EPA previously found the following acceptable as substitutes for HCFC-22 and HCFC-142b in aerosol propellants:

• Alternative processes (pumps, mechanical pressure dispensers, non-spray dispensers)

• Compressed gases (e.g., carbon dioxide, air, nitrogen, and nitrous oxide)

• Dimethyl ether

• HFC-125

• HFC-134a

• HFC-152a

• HFC-227ea

• Saturated light hydrocarbons, C3-C6 (e.g., propane, isobutane, n-butane)

2. EPA is newly finding the following acceptable as a substitute for CFC-11, HCFC-22, HCFC-142b, and blends thereof as an aerosol propellant:

• HFO-1234ze  23

HFO-1234ze is non-ozone-depleting in contrast to the ozone depleting substances which it replaces. In its lack of risk for ozone depletion, HFO-1234ze is comparable to other substitutes for HCFC-22 and HCFC-142b such as HFC-134a, HFC-152a, and compressed CO 2 . HFO-1234ze's 100-year GWP is 6, comparable to or lower than that of other substitutes for CFC-11, HCFC-22 and HCFC-142b. For example, the GWP of HFC-134a is about 1430, the GWP of HFC-152a is about 124, and the GWP of compressed CO 2 is 1.

Neither HFO-1234ze nor any of the previously acceptable substitutes in the propellant end use are HAPs. HFO-1234ze is currently considered a VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. Other acceptable substitutes in the propellant end use that are VOCs are dimethyl ether and the saturated light hydrocarbons (C3-C6). EPA has received a petition to exempt HFO-1234ze from the definition of VOC for purposes of SIPs to attain and maintain the NAAQS on the basis that the chemical has a low photochemical reactivity. EPA intends to address the request through notice-and-comment rulemaking.

HFO-1234ze is not flammable. The toxicity risks of HFO-1234ze are low. The potential health effects of HFO-1234ze at lower concentrations include drowsiness and dizziness. At sufficiently high concentrations, it may cause central nervous system depression or irregular heart beat. HFO-1234ze could cause asphyxiation, if air is displaced by vapor in a confined space. The substitute may also irritate the lungs, skin or eyes or cause frostbite. These potential health effects are common to many propellants. EPA anticipates that users in the propellant end use will take action consistent with the recommendations specified in the manufacturers' MSDSs for HFO-1234ze. EPA recommends a workplace exposure limit of 1,000 ppm on an 8-hour time-weighted average for HFO-1234ze. EPA recommends a preliminary consumer exposure limit (intermittent) of 420 ppm. Our risk screen found that workplace and consumer exposure, respectively, are likely to be well below these levels. 24 EPA anticipates that users will be able to meet the recommended workplace and consumer exposure limits and will address potential health risks by following requirements and recommendations in the MSDSs and labels and other safety precautions common in the aerosol industry. For the above reasons, we find HFO-1234ze acceptable because it does not pose a greater overall risk to human health and the environment than the other substitutes acceptable in the aerosol propellants end use.

Sterilants are chemicals, blends, or devices used to sterilize medical equipment. Many sterilants contain ethylene oxide (EtO) as a component. In this sector, EPA has previously found acceptable ethylene oxide blends containing a blend of HCFC-22 and/or HCFC-124. HCFC-142b has not been used in this sector.

To aid end users in the sterilant end use as they transition from use of ethylene oxide blends containing HCFC-22, this section lists: (1) Sterilants that EPA previously found acceptable as substitutes for ethylene oxide blends containing HCFC-22; and (2) sterilants that EPA is newly finding acceptable as substitutes for ethylene oxide blends containing HCFC-22.

At the end of the decision for the end use, there is narrative comparing environmental, flammability, and toxicity information of the newly acceptable alternative with other currently or potentially available alternatives. Flammable and highly reactive sterilants are hazardous waste when disposed. Sterilants must be registered by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) prior to use. Also, requirements of the Food and Drug Administration for medical devices apply to equipment using sterilants.

More environmental and health information is also available in the original SNAP rule of March 18, 1994, the notice of acceptability in which each substitute was first listed, or the sector table for each of the acceptable alternatives to ethylene oxide blends containing HCFC-22, in the sterilant end use. The sector table is available at http://www.epa.gov/ozone/snap/sterilants/index.html . The sector table also includes further identification information (including composition and trade names) for each substitute.

1. EPA previously found the following acceptable as substitutes for ethylene oxide blends containing HCFC-22 as sterilants:

• IoGas TM Sterilant Blends 1, 3, and 6 (blends of CF 3 I/CO 2 /EtO)

• Mini-Max® Cleaner

2. EPA is newly finding the following acceptable as substitutes for ethylene oxide blends containing HCFC-22 as sterilants:

• CO 2 /EtO

• Hydrogen peroxide gas plasma systems

• Peroxyacetic acid/hydrogen peroxide gas plasma systems

• Pure EtO

• Steam

The newly listed substitutes for HCFC-22, HCFC-142b, and blends thereof listed above in section VII.A.2. are non-ozone-depleting, in contrast to HCFC-22 blends. They are comparable to other acceptable substitutes for HCFC-22 blends in their lack of risk for ozone depletion. The newly listed substitutes have GWPs of one or less, comparable to or lower than that of other substitutes for HCFC-22 blends. For example, the GWP of the IoGas blends is less than one.

Peroxyacetic acid and ethylene oxide are considered VOCs under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the national ambient air quality standards. Ethylene oxide is a hazardous air pollutant under EPA regulations. EPA's National Emission Standards for Hospital Ethylene Oxide Sterilizers apply to this substance and blends that contain it ( see subpart WWWWW of 40 CFR part 63). EPA has previously found other blends containing ethylene oxide to be acceptable as sterilants. Further, blends that do not contain ethylene oxide are often still reactive.

Among the newly listed substitutes for HCFC-22 blends, pure ethylene oxide and peroxyacetic acid, a component in a peroxyacetic acid/hydrogen peroxide gas plasma system, are flammable. Hydrogen peroxide is not flammable per se, but is highly reactive and must be handled cautiously at the concentrations required for use in sterilization equipment. These sterilants should be used in equipment designed to reduce the risks of flammable or highly reactive chemicals. EPA believes that the flammability and reactivity risks can be addressed by existing standards from OSHA, NIOSH, and EPA, and/or by guidelines from the manufacturer, and other safety precautions common during sterilization.

The toxicity risks of the newly listed substitutes for HCFC-22 blends are comparable to the risks of the IoGas blends that EPA previously found acceptable as substitutes for blends of ethylene oxide and HCFCs. Ethylene oxide has an OSHA PEL of 1 ppm on an 8-hour time-weighted average and a NIOSH IDLH of 800 ppm (30-minute). This compound may be carcinogenic. Hydrogen peroxide, used in gas plasma systems, has an OSHA PEL of 1 ppm (8-hr TWA) and a NIOSH IDLH value of 75 ppm (30 min). Peroxyacetic acid, used together with hydrogen peroxide in gas plasma systems, has an AEGL-1 of 0.17 ppm from 10 min to 8 hours to avoid irritation and an AEGL-2 of 0.5 ppm from 10 min to 8 hours to avoid “irreversible or other serious, long-lasting adverse health effects * * *.” ( Acute Exposure Guideline Levels for Selected Airborne Chemicals, Committee on Acute Exposure Guideline Levels, National Research Council of the National Academies, 2009). EPA anticipates that users will be able to meet the workplace exposure limits (PELs, IDLHs, and AEGLs) and will address potential health risks by following requirements and recommendations in the MSDSs and other safety precautions common when working with sterilants. For the above reasons, we find the newly listed substitutes (in VII.A.2, above) acceptable because they do not pose a greater overall risk to human health and the environment than the other substitutes available in the end use.

You can find a complete chronology of SNAP decisions and the appropriate Federal Register citations from the SNAP section of EPA's Ozone Depletion Web site at http://www.epa.gov/ozone/snap/chron.html. This information is also available from the Air Docket ( see ADDRESSES section above for contact information).

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of 40 CFR part 174 through the Government Printing Office's e-CFR site at http://www.gpoaccess.gov/ecfr .

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0609 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 16, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0609, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of September 30, 2009 (74 FR 50196) (FRL-8433-3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 9F7561) by Syngenta Seeds, Incorporated, P.O. Box 12257, Research Triangle Park, NC 27709. The petition requested that 40 CFR part 174 be amended by establishing an exemption from the requirement of a tolerance for residues of Bacillus thuringiensis eCry3.1Ab protein in corn. This notice referenced a summary of the petition prepared by the petitioner Syngenta Seeds, Incorporated, which is available in the docket, http://www.regulations.gov . Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit VII.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....” Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency consider “available information concerning the cumulative effects of a particular pesticide's residues and other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Based on amino acid sequence homology and crystal structures, known Cry proteins have a similar three-dimensional structure comprised of three domains, Domain I, II, and III (Refs. 3, 5, 6 and 7). The toxin portions of Cry proteins are characterized by having five conserved blocks (CB) across their amino acid sequence. These are numbered CB1 to CB5 from the N-terminus to the C-terminus (Ref. 4). The sequences preceding and following these conserved blocks are highly variable and are designated as variable regions V1 to V6.

Syngenta Seeds, Incorporated developed Event 5307 maize ( Zea mays ) through Agrobacterium -mediated transformation (via plasmid vector PV-ZMIR245) to express eCry3.1Ab protein for use as a plant-incorporated protectant (PIP). This proposed PIP is a chimeric Bacillus thuringiensis protein, composed of portions of Cry1Ab and modified Cry3A proteins. The eCry3.1Ab protein was genetically engineered via exchanging the variable regions (V1 to V6) between the mCry3A and the Cry1Ab proteins for enhanced toxicity against western corn rootworm (WCR, Diabrotica virgifera ). The eCry3.1Ab protein consists of a fusion between the N-terminus (Domain I, Domain II, and a portion of Domain III) of mCry3 A and the C-terminus (a portion of Domain III and variable region 6) of Cry1Ab. The eCry3.1Ab protein is 654 amino acid residues in size and is approximately 73.7 kilodaltons.

Syngenta has submitted acute oral toxicity data demonstrating the lack of mammalian toxicity at high levels of exposure to the pure eCry3.1Ab protein. These data demonstrate the safety of the product at a level well above maximum possible exposure levels that are reasonably anticipated in the crop. Basing this conclusion on acute oral toxicity data without requiring further toxicity testing and residue data is similar to the Agency position regarding toxicity testing and the requirement of residue data for the microbial Bacillus thuringiensis products from which this PIP was derived (see 40 CFR 158.2130(d)(1)(i) and 158.2140(d)(7)). For microbial products, further toxicity testing and residue data are triggered by significant adverse acute effects in studies, such as the mouse oral toxicity study, to verify and quantify the observed adverse effects and clarify the source of these effects (Tiers II & III).

An acute oral toxicity study in mice (Master Record Identification Number MRID No. 477539-01) indicated that eCry3.1Ab is nontoxic. Two groups of 10 male and 10 female mice were orally dosed (via gavage) with 2,000 milligrams/kilograms bodyweight (mg/kg bwt) (eCry3.1Ab protein mg/kg bwt) of the eCry3.1Ab-0208 test substance, the microbial-produced eCry3.1Ab protein. All treated animals gained weight and had no test material-related clinical signs and no test material-related findings at necropsy. Since there were no significant differences between the test and control groups related to the oral administration of eCry3.1Ab-0208 test material, the eCry3.1Ab protein does not appear to cause any significant adverse effects at an exposure level of up to 2,000 mg/kg bwt and supports the finding that the eCry3.1Ab protein would be nontoxic to mammals.

When proteins are toxic, they are known to act via acute mechanisms and at very low dose levels (Ref. 8). Therefore, since no acute effects were shown to be caused by eCry3.1Ab, even at relatively high dose levels, the eCry3.1Ab protein is not considered toxic. Further, amino acid sequence comparisons showed no similarities between the eCry3.1Ab protein and known toxic proteins in protein databases that would raise a safety concern.

Since eCry3.1Ab is a protein, allergenic sensitivities were considered. Currently, no definitive tests exist for determining the allergenic potential of novel proteins. Therefore, EPA uses a “weight-of-the-evidence” approach where the following factors are considered: Source of the trait; amino acid sequence similarity with known allergens; prevalence in food; and biochemical properties of the protein, including in vitro digestibility in simulated gastric fluid (SGF) and glycosylation (as recommended by CAC 2003, see Ref. 2). Current scientific knowledge suggests that common food allergens tend to be resistant to degradation by acid and proteases; may be glycosylated; and present at high concentrations in the food.

1. Source of the trait . Bacillus thuringiensis is not considered to be a source of allergenic proteins.

2. Amino acid sequence . A comparison of the amino acid sequence of eCry3.1Ab with known allergens showed no significant overall sequence similarity or identity at the level of eight contiguous amino acid residues. This is the appropriate level of sensitivity to detect possible IgE epitopes without high false positive rates.

3. Prevalence in food . Preliminary expression level analysis shows that the eCry.1Ab protein is present at relatively low levels. Dietary exposure is expected to be correspondingly low. Expression in Event 5307 leaf is 35 parts per million ppm; root is 6 ppm; and pollen is 0.15 ppm. Thus, the expression has been shown to be in the parts per million range.

4. Digestibility . The eCry3.1Ab protein was rapidly digested in simulated mammalian gastric fluid containing pepsin at a pH of 1.2 at 37°C. Theestimated degradation rate (DT50) is less than 1 minute for eCry3.1Ab protein.

5. Glycosylation . The eCry3.1Ab protein expressed in corn was shown not to be glycosylated.

6. Conclusion . Considering all of the available information, EPA has concluded that the potential for eCry3.1Ab to be a food allergen is minimal.

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

The Agency has considered available information on the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances. First, with respect to other related substances, the eCry3.1Ab protein is a chimeric Bacillus thuringiensis protein, composed of portions of Cry1Ab and mCry3A proteins both of which are registered PIPs that were previously assessed as having a lack of mammalian toxicity at high levels of exposure. Exemptions from the requirement of a tolerance have been established for Cry1Ab in food and mCry3A in maize, (see 40 CFR 174.511, effective Apr. 25, 2007 and 40 CFR 174.505, effective Apr. 25, 2007, respectively). Second, and specific to the eCry3.1Ab protein, these considerations include dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for the PIP chemical residue and exposure from non-occupational sources. Exposure via the skin or inhalation is not likely since the PIP is contained within plant cells, which essentially eliminates these exposure routes or reduces these exposure routes to negligible. The amino acid homology assessment included similarity to known aeroallergens. It has been demonstrated that there is no evidence of occupationally-related respiratory symptoms, based on a health survey on migrant workers after exposure to Bt pesticides (Ref. 1). Exposure via residential or lawn use to infants and children is also not expected because the use sites for the eCry3.1Ab protein are all agricultural for control of insects. Oral exposure, at very low levels, may occur from ingestion of processed corn products and, potentially, drinking water.

However, oral toxicity testing done at a dose of 2 gm/kg showed no adverse effects. Furthermore, the expected dietary exposure from corn is several orders of magnitude lower than the amounts of eCry3.1Ab protein shown to have no toxicity. Therefore, even if negligible aggregate exposure should occur, the Agency concludes that such exposure would present no harm due to the lack of mammalian toxicity and the rapid digestibility demonstrated for the eCry3.1Ab protein.

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

Since eCry3.1Ab is not considered toxic, EPA has not found eCry3.1Ab protein to share a common mechanism of toxicity with any other substances, and eCry3.1Ab protein does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that eCry3.1Ab protein does not have a common mechanism of toxicity with other substances. Following from this, therefore, EPA concludes that there are no cumulative effects associated with eCry3.1Ab that need to be considered. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

The data submitted and cited regarding potential health effects for the eCry3.1Ab protein include the characterization of the expressed eCry3.1Ab protein in corn, as well as the acute oral toxicity, heat stability, and in vitro digestibility of the protein. The results of these studies were used to evaluate human risk, and the validity, completeness, and reliability of the available data from the studies were also considered.

As discussed more fully in Unit III. above, the acute oral toxicity data submitted supports the prediction that the eCry3.1Ab protein would be nontoxic to humans. Moreover, eCry3.1Ab showed no sequence similarity to any known toxin. Because of this lack of demonstrated mammalian toxicity, no protein residue chemistry data for eCry3.1Ab were required for a human health effects assessment. Even so, preliminary expression level analysis showed eCry3.1Ab protein is present at relatively low levels. Dietary exposure is expected to be correspondingly low.

In addition, since eCry3.1Ab is a protein, its potential allergenicity was also considered as part of the toxicity assessment. Data considered as part of the allergenicity assessment include that the eCry3.1Ab protein came from Bacillus thuringiensis, which is not a known allergenic source, showed no sequence similarity to known allergens, was readily degraded by pepsin, and was not glycosylated when expressed in the plant. Therefore, there is a reasonable certainty that eCry3.1Ab protein will not be an allergen.

Considered together, the lack of mammalian toxicity at high levels of exposure to the eCry3.1Ab protein and the minimal potential for that protein to be a food allergen demonstrate the safety of the product at levels well above possible maximum exposure levels anticipated in the crop.

Finally, and specifically in regards to infants and children, FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA determines that a different margin of safety will be safe for infants and children.

Based on its review and consideration of all the available information, as discussed in more detail above, the Agency concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of the eCry3.1Ab protein and the genetic material necessary for its production in corn. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has also concluded, again for the reasons discussed in more detail above, that there are no threshold effects of concern and, as a result, that an additional margin of safety for infants and children is unnecessary in this instance.

The Agency has determined that an analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. Nonetheless, a method for extraction and two test strip commercial kits to detect eCry3.1Ab protein via enzyme-linked immunosorbent assay analysis in corn have been submitted and are under review by the Agency.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. In this context, EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for eCry3.1Ab protein in corn.

One comment was received from an anonymous individual who objected in general terms to EPA's registration of any pesticides and its approval of any tolerance or tolerance exemption, claiming that no safety testing is required or undertaken. While the Agency understands that some individuals are opposed to all pesticide use, relavant data (discussed above) did serve as the basis for EPA's conclusion in this instance that there is a reasonable certainty of no harm from residues of Bacillus thuringiensis eCry3.1Ab protein in corn.

The Agency concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of eCry3.1Ab protein in corn and the genetic material necessary for its production. Therefore, a temporary exemption is established for residues of Bacillus thuringiensis eCry3.1Ab protein in or on corn.

1. Bernstein IL, Bernstein JA, Miller M, Tierzieva S, Bernstein DI., Lummus Z, Selgrade MK, Doerfler DL, Seligy VL. 1999. Immune responses in farm workers after exposure to Bacillus thuringiensis pesticides. Environmental Health Perspectives . 107(7):575-82.

2. CAC. 2003. Alinorm 03/34: Joint FAO/WHO Food Standard Programme. Codex Alimentarius Commission, Twenty-Fifth Session, 30 July 2003. Rome, Italy. Appendix III: Guideline for Conduct of Food Safety Assessments of Foods Derived from Recombinant-DNA Plants; Appendix IV: Annex on Assessment of Possible Allergenicity. Codex Alimentarius Commision, 47-60.

3. Ge A, Rivers D, Milne R, Dean DH. 1991. Functional Domains of Bacillus thuringiensis Insecticidal Crystal Proteins. Refinement of Heliothis virescens and Trichoplusiani Specificity Domains on Cry1A(c). Journal of Biological Chemistry . 266: 17954-17958.

4. Hofte H, Whitley HR. 1989. Insecticidal Crystal Proteins of Bacillus thuringiensis. . Microbiology Review . 53: 242-255.

5. Honee G, Convents D, Van Rie J, Jansens S, Peferoen M, Visser B. 1991. The C-Terminal Domain of the Toxic Fragment of a Bacillus thuringiensis Crystal Protein Determines Receptor Binding. Molecular Microbiology . 5: 2799-2806.

6. Li J, Carroll J, Ellar DJ. 1991. Crystal Structure of Insecticidal δ-Endotoxin from Bacillus thuringiensis at 2.5 A resolution. Nature . 353: 815-821.

7. Nakamura K, Oshie K, Shimizu M, Takada Y, Oeda K, Ohkawa H. 1990. Construction of Chimeric Insecticidal Proteins Between the 130-kDa and 135-kDa Proteins of Bacillus thuringiensis subsp. aizawai for Analysis of Structure-Function Relationship. Agricultural Biological Chemistry . 54: 715-724.

8. Sjoblad R D, McClintock JT, Engler R. 1992. Toxicological Considerations for Protein Components of Biological Pesticide Products. Regulatory Toxicology and Pharmacology . 15(1): 3-9.

This final rule establishes a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq. , nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000), do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr . To access the OPPTS harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/oppts and select “Test Methods and Guidelines.”

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0739 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 16, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES . Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2008-0739, by one of the following methods:

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line instructions for submitting comments.

• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

• Delivery : OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In the Federal Register of March 19, 2010 (75 FR 13277) (FRL-8813-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 9E7647) by the Joint Inerts Task Force, Cluster Support Team 13, EPA Company Number 84949, c/o CropLife America, 1156 15th St., NW., Suite 400, Washington, DC 20005. The petition requested that 40 CFR 180.910 and 40 CFR 180.930 be amended by establishing exemptions from the requirement of a tolerances for residues of sodium 1,4-dialkyl sulfosuccinates including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3); sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) when used as inert ingredients in pesticide formulations for pre-harvest and post-harvest uses, as well as, for application to animals. For ease of reading this document the sodium 1,4-dialkyl sulfosuccinates will be referred to as SDSS. That notice referenced a summary of the petition prepared by the Joint Inerts Task Force (JITF), Cluster Support Team Number 13 (CST 13), the petitioner, which is available in the docket, http://www.regulations.gov . No comments were received in the docket. However, the Agency received one comment by e-mail. The comment was received from a private citizen who opposed the authorization to sell any pesticide that leaves a residue on food. The Agency understands the commenter's concerns and recognizes that some individuals believe that no residue of pesticides should be allowed. However, under the existing legal framework provided by section 408 of the FFDCA EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute.

EPA previously published a final rule to establish a tolerance for SDSS under 40 CFR 180.920 in the Federal Register of July 8, 2009 (74 FR 32433) (FRL-8423-3). That final rule established a tolerance exemption for SDSS when used as an inert ingredient in pesticide formulations applied to growing crops only.

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

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

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

Consistent with section 408(c)(2)(A) of FFDCA, and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for SDSS including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with SDSS follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

SDSS have moderate to low acute oral toxicity and low dermal acute toxicity. There was no hazard identified in a combined repeat dose rat reproductive/developmental screening study at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) to either parental animals or their offspring. There is no concern for neurotoxicity, immunotoxicity or carcinogenicity for SDSS.

Specific information on the studies received and the nature of any observed effects caused by SDSS as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http:// www.regulations.gov in the document “Sodium 1,4-Dialkyl Sulfosuccinates (JITF CST 13 Inert Ingredients). Human Health Risk Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” pages 6-8 in docket ID number EPA-HQ-OPP-2008-0739.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level - generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD) - and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm .

There was no hazard identified in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats with SDSS at the limit dose of 1,000 mg/kg/day to either parental animals or their offspring. Thus, due to their low potential hazard and lack of a hazard endpoint, the Agency has determined that a quantitative risk assessment using safety factors applied to a POD protective of an identified hazard endpoint is not appropriate.

No mutagenicity, genotoxicity, or chronic toxicity data have been located for any of the SDSS. However, no structural alerts for genotoxicity or carcinogenicity were identified in a qualitative structure activity relationship (SAR) database, DEREK Version 11. In addition, data for similar compounds showed they are not mutagenic or carcinogenic. The primary alcohol mammalian metabolites of SDSS have been shown to be negative in the in vitro Ames test. Furthermore, a structurally similar compound that is also used as an inert ingredient, sodium dioctyl sulfosuccinate (CAS Reg. No. 577-11-7) was not mutagenic, or carcinogenic in a chronic rat study or a tumor promotion study. Based on the above, SDSS are not expected to be carcinogenic.

1. Dietary exposure from food and feed uses and drinking water . Since an endpoint for risk assessment was not identified, an exposure assessment for SDSS was not conducted. Any possible dietary exposure of SDSS from their use as inert ingredients in pesticide products would be through consumption of food to which pesticide products containing SDSS have been applied and through drinking water (from runoff).

2. From non-dietary exposure . The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

Since an endpoint for risk assessment was not identified, a quantitative residential exposure assessment for SDSS was not conducted. Residential exposures to SDSS may occur as a result of the use of pesticide products containing SDSS as inert ingredients (such as antimicrobial hard surface cleaners) as well as from other, nonpesticidal, residential use products containing SDSS.

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

EPA has not found SDSS to share a common mechanism of toxicity with any other substances, and SDSS does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that SDSS does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative .

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

The toxicity database for SDSS is adequate for FQPA assessment and the potential exposure is adequately characterized given the low toxicity of the chemical. There was no hazard identified in a combined repeat dose rat reproductive/developmental screening study at the limit dose of 1,000 mg/kg/day to either parental animals or their offspring. There is no concern for neurotoxicity, immunotoxicity or carcinogenicity for SDSS.

Based on this information, there is no concern, at this time, for increased sensitivity to infants and children to SDSS when used as inert ingredients in pesticide formulations for pre-harvest and post-harvest uses, as well as for application to animals, therefore a safety factor analysis has not been used to assess risk. For the same reason, EPA has determined that an additional safety factor is not needed to protect the safety of infants and children.

Given the lack of concern for hazard posed by SDSS, EPA concludes that there are no dietary or aggregate dietary/non-dietary risks of concern as a result of exposure to SDSS in food and water or from residential exposure.

Taking into consideration all available information on SDSS, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to SDSS under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 and 40 CFR 180.930 for residues of sodium 1,4-dialkyl sulfosuccinates including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3); sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) when used as an inert ingredient in pesticide formulations for pre-harvest and post-harvest uses, as well as, for application to animals, is safe under FFDCA section 408.

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

The Agency is not aware of any country requiring a tolerance for SDSS nor have any CODEX Maximum Residue Levels been established for any food crops at this time.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 and 40 CFR 180.930 for sodium 1,4-dialkyl sulfosuccinates including sodium 1,4-dihexyl sulfosuccinate (CAS Reg. No. 3006-15-3); sodium 1,4-diisobutyl sulfosuccinate (CAS Reg. No. 127-39-9); and sodium 1,4-dipentyl sulfosuccinate (CAS Reg. No. 922-80-5) when used as an inert ingredient in pesticide formulations for pre-harvest and post-harvest uses, as well as, for application to animals.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq ., nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the exemptions in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq .) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

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

This is a summary of the Commission's Memorandum Opinion and Order, MB Docket No. 05-10, adopted May 21, 2010, and released May 24, 2010. The full text of this Commission document is available for inspection and copying during normal business hours in the FCC Reference Information Center (Room CY-A257), 445 12th Street, SW., Washington, DC.

The complete text of this decision may also be purchased from the Commission's copy contractor, Best Copy and Printing, Inc., 445 12th Street, SW, Room CY-B402, Washington, DC 20554, 800-378-3160 or via the company's website, <http://www.bcpiweb.com>.

The Commission will not send a copy of this Memorandum Opinion and Order pursuant to the Congressional Review Act, see 5 U.S.C. 801(a)(1)(A), because the aforementioned petition for reconsideration was dismissed.

This document does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

Provisions of the Regulatory Flexibility Act of 1980 do not apply to this proceeding.

This interim final rule implements measures contained in Amendment 3, which was approved by NMFS on behalf of the Secretary of Commerce (Secretary) on March 23, 2010. A proposed rule to implement the measures contained in Amendment 3 published in the Federal Register on January 21, 2010 (75 FR 3434), with public comment accepted through February 22, 2010. Details concerning the development of Amendment 3 were contained in the preamble of the proposed rule and are not repeated here.

The January 21, 2010, proposed rule included proposed specifications for FY 2010 and 2011. The proposed specifications were included in Amendment 3 based on the best available scientific information available at the time the final Amendment 3 document was prepared by the Council. Specifically, the proposed specifications included the following: (1) ACL = 30,643 mt; (2) ACT = 22,982 mt; and (3) TAL = 9,427 mt. These proposed specifications derived from the scientific advice of the Council's Scientific and Statistical Committee (SSC) that the acceptable biological catch (ABC) for the skate complex should not exceed 30,643 mt. This recommendation was developed in September 2009 by the SSC, based on the best information considered appropriate for use at the time, which included data from the Northeast Fisheries Science Center (NEFSC) trawl surveys through spring 2008 for little skate, and through fall 2007 for all other species in the skate complex.

Although this was the best scientific information available at the time the Council prepared and submitted Amendment 3 for review by NMFS, in March 2010, the Council's SSC reconvened to reconsider its ABC recommendation for FY 2010 and 2011. The SSC reconsidered its ABC recommendation to incorporate the fall 2008 NEFSC trawl survey data, which had not been previously incorporated into the SSC's evaluation of an appropriate ABC for the skate complex. As a result of the inclusion of these additional data, which showed a marked increase in the availability of winter skates, the SSC revised its ABC recommendation from 30,643 mt to 41,080 mt. Based on the procedures in Amendment 3, a change in the SSC's ABC recommendation affects the specifications to be implemented, as follows: (1) The ACL is similarly increased to 41,080 mt; (2) the ACT increases to 30,810 mt; and (3) the TAL increases to 13,848 mt (the TAL also reflects an updated analysis by the Council's Skate Plan Development Team (PDT) on estimated discards of skates across all fisheries). The SSC presented its recommendation to revise the skate ABC at the April 28, 2010, meeting of the Council. At this meeting, the Council accepted the revised ABC and requested that NMFS incorporate this new scientific information into the implementation of Amendment 3. Therefore, consistent with the request of the Council, the final specifications implemented in this interim final rule reflect this new scientific information from the Council's SSC, as required under National Standard 2 of the Magnuson-Stevens Act (“any regulation promulgated to implement any such [fishery management] plan . . . shall be based upon the best scientific information available”). But, because the scientific basis for setting the FY 2010 and 2011 specifications changed between the publication of the proposed rule and the publication of this interim final rule, the final specifications are published as an interim final rule in order to provide the public with the opportunity to provide comment on the revised specifications.

For all skate species except barndoor, the B MSY proxy (biomass target; the biomass level at which maximum sustainable yield (MSY) can be attained on a continuing basis) is defined as the 75th percentile of the appropriate NEFSC trawl survey (autumn or spring) biomass index time series for that species: Autumn 1975-2007 for clearnose; spring 1982-2008 for little; autumn 1967-2007 for winter and rosette; and autumn 1963-2007 for smooth and thorny. For barndoor, the B MSY proxy remains unchanged as the average 1963-1966 autumn survey biomass index, because the survey did not catch barndoor skates during a protracted time period of years.

A skate species is considered overfished if its 3-year moving average survey biomass falls below one-half of its B MSY proxy value (biomass threshold). Therefore, because the current biomass indices for thorny and smooth skates are below their respective thresholds, they are considered overfished (Table 1). The current biomass for clearnose and rosette skates are above their respective biomass targets, so they are considered to be above B MSY . Winter, little, and barndoor skates are not overfished, but not completely rebuilt to their biomass targets (Table 1).

Fishing mortality reference points, defined by percentage changes in the survey biomass indices, remain unchanged. No skates are currently subject to overfishing, although thorny skate was considered to be subject to overfishing in 2007. The previous and revised biomass reference points are shown in Table 1, relative to the most recent survey biomass for each species.

The following final specifications differ from the specifications proposed in the January 21, 2010, proposed rule. The regulation at § 648.320(a)(7) regarding the annual review and specification process provides that “if the specifications published in the Federal Register differ from those recommended by the Council, the reasons for any differences must be clearly stated and the revised specifications must satisfy the criteria set forth in this section.” As explained above, the final specifications implemented in this interim final rule are based on the revised ABC recommendation of the Council's SSC. The proposed specifications were based on the best information available at the time the Council prepared Amendment 3, but this information changed as a result of the March 17, 2010, meeting of the SSC. Thus, these final specifications differ from those recommended by the Council in Amendment 3 to ensure that the final FY 2010 and 2011 specifications are based on the best available scientific information. Also, because these final specifications were calculated according to the procedures in Amendment 3, stemming from the revised ABC recommendation, the final specifications are determined to satisfy the criteria set forth in Amendment 3.

In each FY, the ACL for the skate complex will be set equal to the ABC recommended by the Council's SSC. Through FY 2011, the SSC has recommended an ABC based on the median catch/biomass exploitation rate of the skate complex multiplied by the 2005-2008 average survey biomass, which is 90.566 million lb (41,080 mt) per year. To account for management uncertainty, an ACT will be set at 75 percent of the ACL, or 67.924 million lb (30,810 mt) per year. Due to the difficulties in monitoring skate discards in all fisheries during a FY, a projection of total annual dead discards will be subtracted from the ACT to generate the TAL for the skate fisheries. After deducting an estimate of skate landings from vessels fishing solely in state waters (approximately 3 percent of the total landings), the remaining TAL for Federal waters in FY 2010 and 2011 will be 30.530 million lb (13,848 mt) per year.

The TAL will be allocated between the skate wing fishery and the skate bait fishery based on historic landings proportions. The skate wing fishery predominantly lands winter skate, while the bait fishery predominantly lands little skate. The skate wing fishery will receive 66.5 percent of the TAL, or 20.302 million lb (9,209 mt), and the skate bait fishery will receive 33.5 percent of the TAL, or 10.227 million lb (4,639 mt). Landings of skates will be monitored and allocated to the appropriate fishery quota through information currently required to be submitted by seafood dealers on a weekly basis.

Because this action was not effective at the start of the FY on May 1, 2010, all skate landings that accrue from May 1, 2010, until the date of implementation of this interim final rule will be counted against the respective skate wing and bait TALs for FY 2010, as described above. The rationale for this attribution of FY 2010 landings was explained in the January 21, 2010, proposed rule.

As part of the final specifications for FY 2010 and 2011, this interim final rule implements a possession limit for the skate wing fishery that differs from the possession limit in Amendment 3 and the proposed rule. The possession limit for the wing fishery is revised in order to reflect the change in TAL allocated to the wing fishery as a result of the ABC. Under Amendment 3, the wing fishery landings are assessed against a yearly TAL that is managed primarily through the use of a possession limit on landings designed to constrain landings such that the TAL is not exceeded. In Amendment 3, the proposed reduction in allowable landings in the wing fishery to the initial 13.821 million lb (6,269 mt) TAL required a substantial reduction in the possession limit, from the original limits of 10,000 lb (4,536 kg) wing weight for all trips less than 24 hr in duration (and 20,000 lb (9,072 kg) wing weight for all trips greater than 24 hr in duration) to the proposed limit of 1,900 lb (862 kg) wing weight for all trips, regardless of trip duration. Consistent with the new ABC recommendation, and the resultant increase in the wing fishery TAL from the 13.821-million-lb (6,269-mt) TAL in the proposed rule to the 20.302-million-lb (9,209-mt) TAL implemented in this interim final rule, the Skate PDT recently completed an analysis indicating that the proposed 1,900-lb (862-kg) wing possession limit should also be revised.

This change from the proposed rule is necessary to ensure that the management measure is based on the best available scientific information, and to provide an opportunity for the fishery to attain the TAL. Based on PDT analyses, if fishing patterns in FY 2010 and 2011 are similar to those in FY 2007-2009, the proposed 1,900-lb (862-kg) wing possession limit was expected to have constrained total wing landings to approximately two-thirds of the overall TAL, while potentially substantially increasing regulatory discards of marketable skates. An increase in the wing possession limit from the level initially proposed provides a greater likelihood that the fishery will have the opportunity to fully attain the TAL, and reduces the potential for a substantial increase in regulatory discards.

All vessels possessing, retaining, and landing skates will continue to be required to obtain a Federal open access skate permit. Subject to the additional restrictions described in the following sections, a possession limit of 5,000 lb (2,268 kg) wing weight (11,350 lb (5,148 kg) whole weight) is implemented for any vessels in possession of skates, unless the vessel is in possession of a Skate Bait Letter of Authorization (LOA). All skates landed in wing form or sold for use as food will accrue against the skate wing TAL. To ensure that the skate wing TAL is not exceeded, when 80 percent of the annual skate wing TAL is landed, the 5,000-lb (2,268-kg) skate wing possession limit will be reduced to 500 lb (227 kg) wing weight (1,135 lb (515 kg) whole weight) for the remainder of the FY. The purpose of this measure is to reduce incentives to target skates, but allow some incidental catches of skates to be landed, rather than discarded.

This rule retains the requirement that a vessel possessing a valid Federal skate permit must also fish under an Atlantic sea scallop, Northeast (NE) multispecies, or monkfish day-at-sea (DAS) in order to possess, retain, and land skates, unless that the vessel is otherwise exempted under § 648.80.

This action also implements an incidental skate trip limit of 500 lb (227 kg) wing weight, or 1,135 lb (515 kg) whole weight, for any vessel issued a Federal skate permit that is not fishing under a DAS.

A possession limit of 20,000 lb (9,072 kg) whole weight is implemented for vessels participating in the skate bait fishery that also possess a Skate Bait LOA. The existing requirements of the Skate Bait LOA will remain in effect, including the requirement to land skates in only whole form, to be sold only as bait, a maximum skate size limit of 23 inches (58 cm) total length, and a minimum participation period of 7 days. Vessels that do not possess a Skate Bait LOA, or that land any combination of whole skates and skate wings (even if the vessel possesses a Skate Bait LOA) are subject to the appropriate wing fishery possession limit. To help maintain a consistent market supply of bait skates, the skate bait TAL will be split into three quota periods per year. All skates landed in whole form that are sold for use as bait will accrue against the skate bait TAL. When 90 percent of the skate bait quota is harvested in each quota period, the possession limit will be reduced to the whole weight equivalent of the skate wing fishery possession limit until the start of the next period, whether it be 5,000 lb (2,268 kg) or 500 lb (227 kg) wing weight at the time.

The bait skate possession limit implemented in this interim final rule is the same as that recommended by the Council in Amendment 3 and in the proposed rule. Although the TAL allocated to the bait fishery is increased in this interim final rule from the level in Amendment 3 and the proposed rule, similar to the wing fishery TAL, the basis for establishing a possession limit for the bait fishery, and the level at which that possession limit was set, was different than for the wing fishery. Rather than an overall annual TAL, the bait fishery TAL is subdivided into three quota periods. When landings of bait skates are projected to reach 90 percent of the quota for each quota period, the bait fishery possession limit is reduced to the standing wing fishery possession limit, until the start of the next quota period. Because of concerns that derby-style fishing, in conjunction with the open-access nature of the bait fishery, could result in early “closures” of the bait fishery (so-called due to the larger volumes of bait skates needed to supply the bait market) that would disrupt the market for bait skates and have substantial negative consequences for the lobster fishery that is largely dependent on skates for bait, the 20,000-lb (9,072-kg) possession limit was suggested by members of the Council's Skate Industry Advisory Panel as a mechanism to control the pace at which the landings approached the quota period limits.

As an additional conservation measure, vessels declared to be fishing on a Northeast Multispecies Category B DAS will have a skate possession limit of 220 lb (100 kg) wing weight (500 lb (227 kg) whole weight).

If the annual TAL allocated to either fishery is exceeded by more than 5 percent in a given year, the possession limit trigger (80 percent in the wing fishery, 90 percent in the bait fishery) will be reduced by 1 percent for each 1-percent overage for that fishery. This measure is intended to help prevent repeated excessive TAL overages.

If it is determined that the ACL for the skate complex was exceeded in a given year, including landings and estimates of discards, then the ACL-ACT buffer (25 percent, initially) will be increased by 1 percent for each 1-percent overage. For example, if the ACL is exceeded by 5 percent, the ACL-ACT buffer will be increased to 30 percent in the subsequent fishing year, which is intended to effectively reduce allowable landings.

In place of the “Skate Baseline Review” process included in the original Skate FMP, the Skate PDT will convene annually to review skate stock status, fishery landings and discards, and determine if any AMs were triggered by fishing in the previous year. The annual review will also incorporate an assessment of changes to other fishery management plans that may impact skates, and determine if changes to skate management measures may be warranted. If changes to the Skate FMP are warranted, the Skate PDT could then recommend to the Council that changes to the skate management measures be made via specifications or framework adjustment. Specifications for the skate fisheries may be implemented for up to 2 years.

A Stock Assessment and Fishery Evaluation (SAFE) report for the skate complex will be completed every 2 years by the Skate PDT. The SAFE report will be the primary vehicle for the presentation of all updated biological and socio-economic information regarding the skate complex and its associated fisheries, and provide source data for any adjustments to the management measures that may be needed to continue to meet the goals and objectives of the FMP.

A total of 11 comments were received on the proposed rule and the amendment from 4 individuals (2 comments from the same individual), 3 industry groups, 2 state agencies (Massachusetts Division of Marine Fisheries (MADMF) and Rhode Island Department of Environmental Protection (RIDEM)), and the Council. Four commenters expressed either general or specific support for the management measures in Amendment 3, one commenter disagreed with NMFS's interpretation of certain provisions necessary to implement the amendment, and four commenters opposed the implementation of Amendment 3. One commenter appeared to be confused about which alternatives were selected by the Council in relation to those that NMFS included in the proposed rule. The comments opposing Amendment 3 and its proposed rule focused on the expected negative economic impacts of the Amendment, particularly the impacts associated with the proposed reductions in the TALs and the possession limits.

This section summarizes the principle comments contained in the individual comment letters that pertained to Amendment 3 and the proposed rule, and NMFS's response to those comments. Any comments received that were not specific to the management measures contained in the Amendment 3 proposed rule, or in the amendment document, are not responded to in this interim final rule.

Comment 1 : The Council noted that the regulatory text describing the AMs in § 648.323 required further clarification to clearly reflect the Council's intent. Specifically, the Council proposed that the term “next fishing year” with respect to the description of the AM to address TAL overages described in section 5.1.3.2 of the amendment, should refer to the year immediately following the year in which the TAL overage occurs. Additionally, the Council noted that the AM to adjust the ACL buffer if skate catches exceed the ACL would be applied in the second fishing year following the year in which the overage occurred, and requested that the language in § 648.323(b) be clarified to be consistent with the description provided in section 5.1.3.3 of the amendment.

Response : In this interim final rule, NMFS has revised § 648.323(b) so that it is clear that any adjustment of the ACL buffer made necessary due to an overage of the ACL would be implemented in the second year following the year for which the overage is determined to have occurred. However, with respect to the TAL overage issue raised by the Council, the amendment provides that, if upon review of the complete landings data from a FY it is determined that a TAL is exceeded by more than 5 percent, the trigger point at which the possession limit is reduced would be adjusted by the same percentage “in the next FY.” For example, if the skate wing TAL is exceeded by 10 percent in one FY, then the AM requires that the wing possession limit trigger would be changed from 80 percent of the wing TAL to 70 percent of the wing TAL. However, the FMP is vague as to the meaning of the “next” FY. Due to the time lags inherent in data collection, and the time necessary to ensure that complete data are used to determine whether a TAL has been exceeded, including time for late data to be collected and entered into the system, data processing, audits, and analysis, it typically would take several months after the end of a FY before NMFS would be able to determine the full extent to which a TAL may have been exceeded. Thus, in all discussions with the Council on this issue, NMFS staff advised the Council that it would not be practicable to make such an adjustment in the FY that immediately follows the year in which the overage occurred. However, in their comment letter on the proposed rule, the Council states that this was, in fact, their intent, and that such AMs should be imposed in the year immediately following the year in which the overage occurred.

In order to implement such a process, at least two rulemakings would be required: The first would be completed in advance of the start of a FY, and would establish the specifications based on the best available information at the time; and the second would be completed several months (potentially up to 6 months) after the start of the FY, to adjust the TAL trigger points to account for any overages determined to occur in the prior FY. This process, and the implications for disruption to the on-going FY, were never discussed by the Council nor analyzed in the Amendment 3 document. Therefore, under its authority at section 305(d) of the Magnuson-Stevens Act, NMFS retains the language that this AM would be implemented in the FY that follows the year in which the overage is identified (i.e., an overage in 2010 would be identified in 2011, once complete data on FY 2010 are available, and the AM would be implemented in FY 2012).

Comment 2 : The Council noted that section 5.1.5 of the amendment recommended that the skate bait fishery TAL be monitored based upon attributing skate landings by vessels with a valid, active Skate Bait LOA to the skate bait fishery, regardless of how those landings are classified by Federal dealers (i.e., as either food or bait). The Council's concern appears to be that dealers may misclassify skates landed in one form as another product form due to processing and/or marketing reasons. The Council further states that the monitoring method proposed by NMFS in § 648.322(a) may lack transparency and result in unexpected possession limit adjustments.

Response : NMFS disagrees that the TAL monitoring method proposed by the Council is the best approach to accurately monitoring the skate TALs being established through this amendment. Council and NMFS staff engaged in several discussions on this issue during the development of Amendment 3. As a result of those discussions, which involved NMFS staff experienced in monitoring landings of other NE fisheries, NMFS determined that using the product classification provided by Federal dealers, as required under § 648.7(a)(1)(i), is the most reliable approach to monitoring the skate TALs, because it most accurately reflects how the product is being utilized, versus the form (wing or whole) in which it was landed. Furthermore, the regulations deemed by the Council to be consistent with Amendment 3 clearly state that the dealer's product classification will be used to allocate skate landings to the appropriate TAL, not possession of the Skate Bait LOA as suggested by the Council in the comments on the proposed rule. Thus, the method described in the proposed rule to monitor skate landings is being implemented in this interim final rule.

Comment 3 : The Council further noted that a provision in § 648.322(b) of the proposed regulations would have exempted vessels targeting skate that also participate in an approved sector under the NE Multispecies FMP from the requirement to use either a NE multispecies, monkfish, or scallop DAS in order to land skate wings was not the intent of the Council in developing Amendment 3. The Council cites the baseline measure identified in section 4.16.1 of the original Skate FMP as evidence that the Skate FMP relies on the DAS mechanism in other fisheries to control access to the skate resource. The Council also notes that section 5.1.8 of Amendment 3 establishes a 500-lb (227-kg) whole weight (200-lb (91-kg) wing weight) possession limit for vessels fishing under a NE multispecies Category B DAS to prevent vessels from using these DAS to target skates because these DAS were originally intended under the NE Multispecies FMP to allow vessels to target stocks at “healthy” biomass levels, while Amendment 3 is intended to reduce skate fishing effort. The Council further cites inequity with non-sector vessels and concern over how the removal of the DAS requirement for sector vessels could increase targeting of skates by these vessels.

Response : The Council's Amendment 3 document is internally inconsistent with respect to this issue, stating that vessels targeting skates must be under a DAS in some sections and not in others. Furthermore, the regulations deemed by the Council to be consistent with Amendment 3 at its April 2009 meeting were silent on this issue. As a result, NMFS included a provision in the proposed rule to address the complicated interaction between the new NE multispecies sectors authorized by Amendment 16 and the skate fishery. However, given the Council's comments on this issue, it is clear that it did not intend for sector vessels to be exempt from DAS requirements for the purpose of targeting skate wings. Thus, it appears the regulations deemed by the Council to be consistent with Amendment 3 were consistent with its intent. Therefore, this interim final rule removes the sector provision in the proposed rule from the regulations. As a result, all vessels landing skate wings in excess of the proposed 500-lb (227-kg) (wing weight) incidental limit will be required to utilize a NE multispecies, monkfish, or scallop DAS. This change is consistent with the Council's comments on this issue, as well as similar comments made by MADMF.

Comment 4 : Three industry members and one industry group submitted comments recommending that some form of limited access or history-based allocations be developed and implemented for the bait skate fishery to mitigate the economic impacts of Amendment 3 and ensure a steady supply of bait for the lobster fishery. Three of these individuals specifically asked that such a provision be included in Amendment 3.

Response : This measure was not included nor specifically considered in Amendment 3, and, therefore, NMFS has no legal authority to establish such a measure as part of the implementation of Amendment 3. However, the Council is aware that some members of the bait skate fishery would like such a program, and on July 30, 2009, at the request of the Council, NMFS established a control date for the bait skate fishery for this purpose. The effect of this control date is to preserve the opportunity for the Council, should it elect at some time in the future to develop and implement a limited access program for the bait fishery that may distinguish participation before and after July 30, 2009. The Council may take up this issue at any time deemed appropriate.

Comment 5 : One individual, two industry groups, and two state agencies raised concerns about the TALs and possession limits proposed in Amendment 3. The commenters suggest that new scientific information indicates that the TALs proposed in the January 21, 2010, proposed rule, which would have represented substantial reductions from recent landings, along with the proposed possession limits, are unnecessary and would result in economic harm to the fishing industry dependent on skates. These commenters urged NMFS and the Council to incorporate this new scientific information as soon as possible and set FY 2010 total allowable catch and trip limits accordingly.

Response : The “new scientific information” referred to in the comment letters is the 2008 fall trawl survey data, which were reviewed by the SSC at its March 17, 2010, meeting. As explained earlier in this preamble, the SSC reconsidered the FY 2010-2011 ABC recommendation for the skate complex using the updated survey data, and provided a new ABC recommendation of 41,080 mt. Based on the recommendation of the SSC, the Skate PDT met on April 7, 2010, to discuss options for revising the trip limits for the wing fishery to achieve the new target TAL. Therefore, as urged by these commenters, this interim final rule revises the specifications in the proposed rule and implements final specifications that are consistent with the new scientific information. This interim final rule adjusts the ABC, associated TALs, and wing possession limit to be consistent with the most recent recommendation of the SSC, as requested by the Council.

Comment 6 : One individual submitted a comment opposing a bait trip limit lower than the amount he currently catches, and stated that the wing fishery should not be included in the bait fishery.

Response : This interim final rule implements a trip limit of 20,000 lb (9,072 kg) of whole skate for the skate bait fishery. Originally, the Council's preferred option had no trip limit for the bait fishery, but relied entirely on a seasonal quota to control landings. However, at the request of members of the bait fishery that serve on the Council's industry advisory panel, the Council adopted a 20,000-lb (9,072-kg) trip limit implemented in this interim final rule as a means of ensuring a steady supply of bait by preventing the seasonal quotas from being reached too quickly. Additionally, NMFS clarifies that the skate wing fishery is not considered part of the bait skate fishery. The Council and NMFS recognize the differences between these two fisheries and, through the Skate FMP, have adopted specific measures to manage these fisheries differently. This individual may be confused as to how the TALs for the skate wing fishery and the bait skate fishery are derived. An overall TAL is established for the NE skate complex, which is then split into specific TALs for the skate wing fishery and bait skate fishery based upon the percentages approved in Amendment 3 and implemented through this interim final rule.

Comment 7 : In addition to the comments above regarding the proposed TAL and possession limits, RIDEM also provided several other comments. The RIDEM questioned the rationale for imposing “drastic reductions” on the bait skate fishery, suggested that the proposed rule is contrary to the alternatives selected by the Council, and suggested that steps should be taken to address the seasonality of the bait skate fishery and the need for a steady supply of bait skates.

Response : NMFS is not proposing to implement an alternative not selected by the Council. RIDEM suggests that the Council selected alternative 1B for the wing fishery and alternative 4 for the bait fishery; however, the Amendment 3 document, and the Council record, clearly indicate that the Council's final decision was to select alternative 3B for the wing fishery, along with alternative 4 for the bait fishery. Alternative 1B would have required implementation of time and area closures for all fishing gear capable of catching skates, which would have included gear used in the sea scallop, monkfish, and groundfish fisheries. This alternative was not favored by either the Council or the fishing industry that provided comments to the Council during the development of Amendment 3.

As to the comments on the measures for the bait fishery, the Amendment 3 document clearly explains that the catch and landings of skates cannot be reliably distinguished by species, and that the best scientific advice from the Council's SSC is to establish catch limits (ABC, ACL, TALs) at the complex level (that is, inclusive of all seven skate species). Therefore, if the complex-level ABC is reduced, or discards of skates increase, then the resulting reduction in the overall skate TAL would necessitate a reduction in the TALs available to both the bait and wing fisheries. Also, RIDEM appears to misunderstand the specific actions proposed in Amendment 3 for the bait fishery. The proposed system of three quota periods (rather than a single annual quota) was designed precisely to maximize the probability of ensuring a steady supply of bait skates when most needed. The annual TAL is not divided equally among the three quota periods, but is allocated based on evidence of the seasonality of this fishery; in fact, 66.7 percent of the annual TAL is allocated to the quota period May-October, which is the season RIDEM indicates has the highest demand for bait skates. Also, the 20,000-lb (9,072-kg) possession limit proposed for the bait skate fishery was suggested initially by members of the bait skate fishing industry as a way to maintain a consistent supply of skates by controlling landings and avoiding a derby fishery.

At its April 2009 meeting, the Council reviewed the draft regulations and deemed them necessary and appropriate for implementation of Amendment 3, as required under section 303(c) of the Magnuson-Stevens Act. Technical changes to the regulations deemed necessary by the Secretary for clarity may be made, as provided under sections 304(b) and 305(d) of the Magnuson-Stevens Act. This interim final rule makes minor technical changes to the proposed rule to address an issue of clarity concerning ACL overages that was raised by the Council in its comments; to clarify the regulatory text concerning the Skate Bait LOA; and to correct an incorrect cross-reference in the proposed rule. These changes are listed below in the order in which they appear in the regulations.

In § 648.322(c), the wording “when a vessel is fishing pursuant to the terms of the authorization” is added to the introductory paragraph for clarity. Additionally, the last sentence under § 648.322(c)(4) is removed and a new § 648.322(c)(5) is added to more clearly reflect the conditions under which a vessel in possession of a Skate Bait LOA may retain skate wings.

In § 648.323(b), the phrase “in the subsequent fishing year” is revised to read “in the second fishing year following the fishing year in which the ACL overage occurred,” to more accurately reflect when the intended action will occur.

In § 648.323(c), the cross-reference to paragraph § 648.323(c) is corrected to read paragraph (d).

In addition to the changes identified above, and consistent with the requirement under National Standard 2 of the Magnuson-Stevens Act that “any regulation promulgated to implement any such [FMP] . . . shall be based upon the best scientific information available,” NMFS is implementing final specifications for FY 2010 and 2011 that differ from the proposed specifications. The authority for NMFS to deviate from the specifications included in Amendment 3 is provided at § 648.320(a)(7), which stipulates that the specifications published in the Federal Register may differ from those recommended by the Council, so long as the reasons for the differences are clearly stated and the revised specifications satisfy the criteria in the regulations. This regulation (§ 648.320(a)(7)) was deemed by the Council to be necessary and appropriate for the implementation of Amendment 3, and was included in the January 21, 2010, proposed rule. The scientific basis for the revised final specifications is provided earlier in the preamble to this interim final rule and is not repeated here. As part of the final specifications for FY 2010 and 2011, the following regulation has been revised.

In § 648.322(b)(1), the skate wing possession limit is revised to read “Up to 5,000 lb (2,268 kg) of skate wings (11,350 lb (5,148 kg) whole weight) per trip, except . . .”

The Administrator, Northeast Region, NMFS, determined that the management measures implemented by this interim final rule are necessary for the conservation and management of the NE skate fishery, and are consistent with the Magnuson-Stevens Act and other applicable laws.

This interim final rule has been determined to be not significant for purposes of Executive Order (E.O.) 12866.

The Council prepared an FEIS for Amendment 3. A notice of availability was published on January 22, 2010 (75 FR 3730). The FEIS describes the impacts of Amendment 3 measures on the environment. Most of these measures were designed to reduce skate landings. As a result, the impacts are primarily social and economic, as well as biological. In general, all biological impacts are expected to be positive. Although some of the economic and social impacts may be negative in the short term, particularly for vessels that have traditionally targeted or relied substantially on sales of skates, the long-term social and economic benefits of sustainable skate fisheries would be positive. In approving the Amendment 3 on March 23, 2010, NMFS issued a Record of Decision (ROD) identifying the selected alternatives. A copy of the ROD is available from NMFS (see ADDRESSES ).

The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive prior notice and the opportunity for public comment on the revised final specifications for FY 2010 and 2011 because it is unnecessary, impracticable, and would be contrary to the public interest. On January 21, 2010, NMFS published a proposed rule in the Federal Register for Amendment 3 to the Skate Complex FMP. This proposed rule included proposed specifications for FY 2010 and 2011 that were consistent with the best scientific information available at the time (i.e., the September 2009 recommendations of the Council's SSC) and that were derived according to the protocols in Amendment 3 for calculating an ACT and associated TALs based on the ABC recommendation. After the comment period on the proposed rule closed, but before this interim final rule was prepared, the Council's SSC reconvened in late March 2010 to consider newly available information regarding the status of the skate complex. As a result of this new information, the SSC revised its recommendation for the skate ABC for FY 2010 and 2011. At its April 28, 2010, meeting, the Council accepted the revised ABC and requested that NMFS incorporate this new scientific information into the implementation of Amendment 3. The final specifications implemented in this interim final rule are consistent with the new ABC recommendation, which is now considered to be the best scientific information available.

Providing an additional opportunity for public comment on the final specifications is unnecessary because the public was provided an opportunity to consider, and provide comments on, the changes to the specifications resulting from the revised ABC recommendation in advance of and during a public meeting of the Council held on April 28, 2010, and NMFS has fully considered those comments in modifying the specifications in this interim final rule.

The April 28, 2010, Council meeting was open to the public, and prior notice of this meeting was announced in the Federal Register on April 8, 2010 (75 FR 17901). The meeting notice explained that the Council's SSC would provide its report to the Council on the revised ABC recommendation for skates, and that the Council would consider taking action and potentially revising management measures for the skate fishery. Members of the skate fishing industry and the general public attended the meeting, and several provided comments to the Council on the issue at hand (i.e., revising the FY 2010 and 2011 specifications to be consistent with the new ABC recommendation). At that meeting, following an open public discussion, the Council adopted a motion to incorporate the new ABC from the SSC into Amendment 3 and adjust the skate wing possession limit. The motion passed unanimously, with one abstention. Also, based on the comments received on the proposed rule, and the public review by the Council of the new ABC and its implications for the FY 2010 and 2011 specifications, there is widespread expectation in the skate fishing industry that the specifications will be revised as soon as possible to reflect the new ABC. Therefore, providing an additional opportunity for public comment on the final specifications is unnecessary.

Providing an additional opportunity for public comment on the final specifications is impracticable and contrary to the public interest for two reasons: (1) FY 2010 began on May 1, 2010, and until these final specifications are implemented, there is significant uncertainty and confusion within the fishing industry regarding the regulations to which the fishery is currently subject, and as to the regulations that will be implemented for the remainder of FY 2010; and (2) until these final specifications are implemented, the fishery is subject to the less restrictive measures in place prior to Amendment 3, which are inconsistent with the best available scientific information on the status of the skate resource and could result in disruptions to the fishing industry. Amendment 3 to the Skate FMP represents a significant change in the management regime for the skate fishery. For one, Amendment 3 establishes an ACL and AMs consistent with the reauthorized Magnuson-Stevens Act. As part of the ACL and AM management structure, specific TALs are derived and allocated separately to the skate wing and bait skate segments of the skate fishery. A possession limit is imposed for the first time on the bait skate fishery, which will now operate under three seasonal quotas, with the potential for the possession limit to be reduced if the seasonal quota trigger threshold is reached. Although the skate wing fishery has operated under a possession limit prior to Amendment 3, the amendment proposed a significant reduction in this limit (and although higher than initially proposed, these final specifications implement a possession limit that remains substantially below the pre-Amendment 3 limits), and the wing fishery now faces further restrictions in allowable landings if the TAL trigger threshold is reached too early in the FY. These new measures are necessary for the conservation and management of the skate resources, and are required under the reauthorized Magnuson-Stevens Act. However, until this interim final rule, including the revised final specifications, is implemented, the fishery remains free to operate under the less restrictive pre-Amendment 3 regulations.

Continued operation under the less restrictive pre-Amendment 3 regulations for the time it would take to proceed with an additional proposed rule and opportunity for public comment would significantly increase the risk of substantial disruptions to the skate fishery and the businesses that depend upon it, due to unexpected reductions in possession limits if TAL trigger thresholds are reached earlier than planned. This could also have the effect of limiting the availability of skate products on the market to the detriment not only of skate vessels and dealers, but also of the entire southern New England lobster fishery, which depends almost entirely on skates for use as bait. As noted above, the FY began on May 1, 2010, and the fishery is currently operating under the less restrictive pre-Amendment 3 regulations, which include unlimited possession by the bait fishery and much higher possession limits by the wing fishery than allowed under this rule. However, all landings by the bait and wing fisheries that occur between May 1, 2010, and the effective date of this interim final rule will be counted against the respective fishery TALs once the TALs are implemented. If landings during this interim period exceed those that would be expected under the Amendment 3 measures, then it is likely that the TAL trigger thresholds may be reached earlier in the FY than planned or expected. This could result in disruptions not just to the skate fisheries, which would be subject to earlier than expected reductions in allowable landings, but also to the lobster fishery and the businesses that depend upon it, due to an unexpected reduction in the supply of lobster bait (which is the primary use of bait skates). The lobster fishery, in particular, depends upon a steady, consistent supply of bait skates year round. The measures in Amendment 3, with the bait skate TAL allocated across three quota periods, in combination with a 20,000-lb (9,072-kg) per trip possession limit, were carefully crafted in consultation with the fishing industry to minimize such disruptions. Delaying implementation of the final specifications even longer than has already occurred, in order to solicit additional public comments, would only increase the likelihood of early reductions in allowable landings and disruptions in the fishery that are contrary to the public's interest.

NMFS could not have completed prior notice and comment rulemaking on the final specifications for FY 2010 and 2011 any earlier, because the Council's SSC did not meet until late March 2010 to consider the newly available information on the skate resources, and did not present a final recommendation on the revised ABC until the April 28, 2010, Council meeting. The Council, similarly, did not take a position on incorporating this new ABC into the Amendment 3 specifications process until April 28, 2010, nor did the Council evaluate the analyses completed by its PDT regarding the need to modify the skate wing fishery possession limit to be consistent with the revised specifications until this time. Immediately following the conclusion of the April 2010 Council meeting, and the decisions and recommendations by the Council and its SSC therein, NMFS undertook to revise this interim final rule implementing Amendment 3 to ensure it remains consistent with the best available scientific information and the intent of the Council.

Although prior notice and comment have been waived for the final FY 2010 and 2011 specifications implemented in this rule, NMFS is publishing this rule as an interim final rule and providing an opportunity for additional public comment to be submitted for 30 days following publication. NMFS will consider any comments submitted and may further revise the final specifications based on the comments received.

NMFS, pursuant to section 604 of the Regulatory Flexibility Act (RFA), has prepared a FRFA in support of Amendment 3. The FRFA incorporates the IRFA, a summary of the significant issues raised by the public comments in response to the IRFA, NMFS's responses to those comments, and a summary of the analyses completed to support the action. A copy of the IRFA, RIR, and FEIS are available upon request (see ADDRESSES ). A summary of the IRFA was published in the proposed rule for this action and is not repeated here. A description of why this action was considered, the objectives of, and the legal basis for this rule is contained in the preamble to the proposed rule and this interim final rule and is not repeated here.

Eleven public comments were submitted on the proposed rule. Although none of these comments were specific to the IRFA, several commenters noted the negative economic effects of the proposed possession limit for the skate wing fishery in Amendment 3. NMFS has responded to these comments in the Comments and Responses section of this preamble. Several changes were made to the final specifications for FY 2010 and 2011 implemented in this interim final rule that are pertinent to some of the comments received. As described earlier in this preamble, the final specifications implemented in this action have been revised to be consistent with the most recent scientific information represented by the new ABC recommendation from the Council's SSC. Thus, consistent with several of the comments on the proposed rule, the final specifications for FY 2010 and 2011 are as follows: (1) An ABC and ACL = 41,080 mt; (2) an ACT = 30,810 mt; (3) a Federal waters TAL = 13,848 mt; (4) wing and bait TALs = 9,209 mt and 4,639 mt, respectively; and (5) a skate wing possession limit of 5,000 lb (2,268 kg) per day (wing weight).

All of the entities (fishing vessels) affected by this action are considered small entities under the Small Business Administration size standards for small fishing businesses ($4.0 million in annual gross sales). Therefore, there are no disproportionate effects on small versus large entities. Information on costs in the fishery is not readily available, and individual vessel profitability cannot be determined directly; therefore, expected changes in gross revenues were used as a proxy for profitability.

The participants in the commercial skate fishery were defined using Northeast dealer reports to identify any vessel that reported having landed 1 lb (0.45 kg) or more of skates during calendar year 2007. These dealer reports identified 542 vessels that landed skates in states from Maine to North Carolina out of 2,685 vessels that held a Federal skate permit.

This action does not introduce any new reporting, recordkeeping, or other compliance requirements. This interim final rule does not duplicate, overlap, or conflict with other Federal rules.

All of the alternatives considered in this action were developed by the Council based on input from members of the skate fishing industry that serve on the Council's industry advisory panel. Other than the no action alternative, of all the alternatives developed by the Council and considered in Amendment 3, the set of management measures implemented in this interim final rule represent those with the least economic impact on small entities. Based on the best available scientific information on the status of the skate complex, in order to be consistent with the requirements and intent of the ACL provisions of the reauthorized Magnuson-Stevens Act, as well as the National Standard 1 guidelines, the overall catch (inclusive of landings and dead discards) of skates must be reduced up to 26 percent from recent catch levels. All of the alternatives considered in Amendment 3, with the exception of the no action alternative, were designed to achieve this reduction in catch, albeit in different ways. But, because all of the relevant alternatives are designed around a catch reduction, there are economic impacts associated with them that would be borne by the fishing industry. The only alternative considered in Amendment 3 that would not result in any direct economic impacts on the skate fishing industry was the no action alternative; however, this alternative could not be implemented because it is inconsistent with the requirements and intent of the Magnuson-Stevens Act.

Alternatives 1A, 1B, 2, and 4 proposed time and/or area closures for bottom-tending fishing gears in the Gulf of Maine and Southern New England as a method to reduce skate catch in the NE multispecies, monkfish, and scallop fisheries primarily. These closures, however, would have restricted vessels from harvesting their more valuable target species. One reason the preferred alternative was selected (a combination of Alternatives 3B and 4) was that it did not include any time/area closures, and minimized the impact of the Skate FMP on other fisheries that only incidentally catch skates. The preferred alternative puts more focus on reducing only skate landings, and therefore skate revenues, rather than potentially reducing landings and revenues from higher valued species across a broader spectrum of New England fisheries, which would have had a direct economic impact on far more small entities than the preferred alternative. Because skates are a comparatively low value species, the preferred alternative focuses the anticipated economic impacts to the skate fishery, rather than on the NE multispecies, monkfish, or scallop fisheries.

The preferred alternative also attempts to minimize economic impacts by using a target TAC approach rather than a hard TAC approach. Under the target TAC alternatives, landings of skates are never completely prohibited as the TAC is approached. Possession limits will be reduced, but as incidental catch of skates is unavoidable in many fisheries, those catches could be converted to landings rather than to discards. Under the hard TAC alternatives, when the TAC was harvested, all skate catch would have to be discarded.

Dividing the skate bait fishery TAL into three seasons, as described in Alternative 4, in combination with the 20,000-lb (9,072-kg) per trip bait skate possession limit, is anticipated to minimize economic impacts on the skate bait fishery. Due to the market dynamics in the skate bait fishery and the need to fill bait orders for the lobster fishery, a bait fishery closure too early in the year could result in economic hardship for skate bait fishermen as well as lobster fishermen. The three seasonal quotas are intended to help ensure that any skate bait fishery closures would be short term, and landings would be able to continue late in the FY, allowing for a relatively constant supply of bait year round.

This interim final rule also implements revised final specifications for FY 2010 and 2011, consistent with the best scientific information available, as described above. These final specifications are substantially higher than the specifications described in the proposed rule and IRFA, and are expected to impose less significant costs to the fishing industry in the form of overall landings limits (TALs) 47 percent higher than initially proposed. Also, based in part on comments received on the proposed rule and relevant to the IRFA, this action increases the per-trip possession limit for the skate wing fishery from 1,900 lb (862 kg) to 5,000 lb (2,268 kg) wing weight. This measure will also minimize the economic impacts associated with this action on the participants of the wing fishery.

Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall explain the actions a small entity is required to take to comply with a rule. As part of this rulemaking process, a small entity compliance guide was prepared. The guide will be sent to all holders of permits issued for the Northeast skate fishery. In addition, copies of this interim final rule and guide (i.e., permit holder letter) are available from the Regional Administrator, NMFS (see ADDRESSES ).

Fisheries, Fishing, Recordkeeping and reporting requirements.