This rule is issued under the Mango Promotion, Research, and Consumer Information Order (Order) [7 CFR part 1206]. The Order is authorized by the Commodity Promotion, Research, and Information Act of 1996 (Act) [7 U.S.C. 7411-7425].

The Office of Management and Budget (OMB) has waived the review process required by Executive Order 12866 for this action.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have a retroactive effect.

Section 524 of the Act provides that the Act shall not affect or preempt any other State or Federal law authorizing promotion or research relating to an agricultural commodity.

Under the Act, a person subject to an order may file a petition with the U.S. Department of Agriculture (Department) stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and requesting a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, the Department will issue a ruling on the petition. The Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of the Department's final ruling.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities that would be affected by this rule. The purpose of the RFA is to fit regulatory action to scale on businesses subject to such action, so that small businesses will not be disproportionately burdened.

The Small Business Administration defines small agricultural producers as those having annual receipts of no more than $750,000, and small agricultural service firms as those having annual receipts of no more than $7 million (13 CFR part 121). First handlers, importers, wholesalers, and retailers would be considered agricultural service firms. Currently, fewer than five first handlers and 193 importers are subject to assessment under the Order. The majority of producers would be considered small businesses. The majority of these first handlers and importers would be considered small businesses, while wholesalers and retailers would not.

First handlers and importers who market or import less than 500,000 pounds of mangos annually are exempt from the assessment. Mangos that are exported out of the United States are also exempt from assessment. In addition, domestic producers, foreign producers, wholesalers, and retailers are not subject to assessment under the Order, but such individuals are eligible to serve on the Board along with importers and first handlers.

Section 1206.30(c) of the Order requires that the Board review the volume and geographical distribution of mango production and imports at least once every five years. If warranted, the Board will recommend to the Department that membership on the Board be altered to reflect any changes in the volume and geographical distribution of mango production and imports.

The Order currently provides for a Board of 20 members including eight importers, one first handler, two domestic producers, seven foreign producers, and two non-voting wholesalers and/or retailers. At its November 16, 2010 meeting, the Board reviewed the volume and geographic distribution of mango production and imports from 2006 through 2009. Based on data from U.S. Customs and Border Patrol, the volume of mango imports to the U.S. declined from 666,772,761 pounds in 2006 to 627,271,605 pounds in 2009. The Board's eight importer seats are allocated based on the volume of mangos imported into each of the four Districts defined in the Order. The current allocation is two seats for District I, three seats for District II, two seats for District III, and one seat for District IV. The percentage of the total mango import volume imported into District I remained at 25 percent from 2006 to 2009. Imports into District II grew from 35 percent of the total in 2006 to 41 percent in 2009. Imports into District III fell from 28 percent of the total in 2006 to 23 percent in 2009. Imports into District IV fell from 12 percent of the total in 2006 to 11 percent in 2009. Much of the domestic mango production was adversely affected by hurricanes during the early 2000s. Accordingly, data provided by the Board shows that in 2006, no assessments were collected on domestic mangos, while in 2009 assessments were collected on 1,539,306 pounds of domestic mangos. After reviewing the data regarding mango imports and domestic production, the Board voted to recommend that no changes be made at this time to the number of importer, first handler, domestic producer, or foreign producer seats; or to the allocation of importer seats among the four districts.

At the same meeting, the Board voted to request elimination of the wholesaler/retailer positions from the Order. These positions were included so that the Board would include members with direct customer sales experience. The Board has made numerous attempts to nominate individuals to those positions; however, wholesalers and retailers are not interested in or do not have the time to serve on the Board. As a result, the two wholesaler/retailer positions have been vacant since 2008. These two positions do not represent assessment payers. If the wholesaler/retailer positions are eliminated, the Board would consist of a total of 18 members including eight importers, one first handler, two domestic producers, and seven foreign producers.

Nominations and appointments to the Board are conducted pursuant to sections 1206.31 and 1206.33 of the Order. Appointments to the Board are made by the Secretary from a slate of nominated candidates. Pursuant to section 1206.31 of the Order, candidates for the importer, first handler, and domestic producer positions are nominated by their peers. Nominations for the foreign producer positions are solicited from foreign mango producer organizations. The Board nominates the wholesaler/retailer members. The Order requires that two nominees be submitted for each vacant position.

In accordance with OMB regulation [5 CFR part 1320], which implements information collection requirements imposed by the Paperwork Reduction Act of 1995 [44 U.S.C. 3501 et seq. ], there are no new requirements contained in this rule. In fact, a decrease of 0.33 hours per year in the information collection burden for the mango program is expected. The information collection requirements have been previously approved by OMB under OMB control number 0581-0093.

The Department has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

The Order, which became effective November 3, 2004, is authorized under the Act and administered by the Board. The Order provides for a 20-member Board consisting of eight importers, one first handler, two domestic producers, seven foreign producers, and two non-voting wholesalers and/or retailers.

Under the Order, the Board administers a nationally coordinated program of promotion, research, and information designed to strengthen the position of mangos in the marketplace and to develop, maintain, and expand the demand for mangos in the United States. The program is financed by an assessment of 1/2 cent per pound on first handlers and importers who market or import 500,000 pounds or more of mangos annually. Under the Order, first handlers remit assessments directly to the Board, and assessments paid by importers are collected and remitted by U.S. Customs and Border Patrol.

Pursuant to section 1206.30(c) of the Order, at least once in each five-year period, the Board shall review the volume and geographical distribution of mango production and imports and, if warranted, make a recommendation to the Secretary to alter the Board's membership. On November 16, 2010, at its fall meeting, the Board voted to recommend that no changes be made to the importer, first handler, domestic producer, or foreign producer positions, but that the non-voting wholesaler/retailer positions be eliminated. If the wholesaler/retailer positions are eliminated, the Board's membership will be reduced from 20 to 18.

Accordingly, this action will amend the Order by removing the definition of retailer in section 1206.19, the definition of wholesaler in section 1206.24, and references to wholesalers and/or retailers in sections 1206.31 and 1206.32.

A proposed rule concerning this action was published in the Federal Register on March 14, 2011 [76 FR 13530]. Copies of the proposed rule were made available on the Internet by the Department and the Office of the Federal Register. In addition, AMS published a press release announcing the comment period. The proposed rule provided a 30-day comment period, which ended April 13, 2011. Twelve comments were received by the deadline.

In response to the proposed rule, USDA received 12 comments regarding the proposed amendment of the Order to eliminate two non-voting wholesaler/retailer positions on the Board. Of the 12 comments received, nine supported the proposed amendment and three did not support the proposed amendment.

A total of eight comments in support of the proposed amendment discussed the Board's reasons for requesting elimination of the wholesaler/retailer positions. Seven of the comments cited the potential for conflict of interest created by participation of wholesalers and/or retailers in Board meetings where decisions could be influenced by their business interests with individual Board members.

Five comments in favor of the proposed amendment mentioned the Board's retention of retail account managers who gather input from the retail sector and help the Board to develop appropriate programs. These commenters stated that having a dedicated team of retail account managers is an effective means of communicating with wholesalers and retailers.

Five comments expressed support for the elimination of the wholesaler/retailer positions on the basis that input from wholesalers and/or retailers can be obtained as needed through their ad hoc participation on the Board's committees. The Board's bylaws permit the Board's chairman to appoint committees that may include persons other than Board members. Subject to Board approval, committee chairmen are also permitted to appoint committee members who are not Board members.

Four commenters supported elimination of the wholesaler/retailer positions, stating that past wholesaler/retailer members struggled with the time and travel demands of Board membership and rarely attended Board meetings.

Three comments in favor of the proposed amendment stated that the funds used to service the wholesaler/retailer positions would be better spent on the Board's promotional programs.

One commenter agreed with the proposed rule without providing additional explanation.

Two commenters expressed opposition to the notion that representation on the Board is linked to the payment of assessments. The Order requires a review of the composition of the Board to be conducted every five years and states that the review is to be based on Board assessment records and statistics from USDA. The number of importer, first handler, and domestic producer seats, as well as the distribution of importer seats, is adjusted as needed based on the volume and geographic distribution of mango production and imports. In addition, the volume of imports for each country of origin is considered in appointments of foreign producer members. Because the volume handled or imported is linked to the value of assessments received by the Board, representation of importers, first handlers, domestic producers and foreign producers is necessarily linked to the payment of assessments. However, that is not the case for the wholesaler/retailer positions.

Two commenters expressed opposition to the proposed elimination of the wholesaler/retailer positions on the grounds that wholesalers and/or retailers could provide valuable insight to the Board. As stated above, the Board's bylaws permit the participation of non-members on the Board's committees. Thus the Board is able to seek input from wholesalers and/or retailers as needed.

One commenter expressed doubt that the Board has made sufficient efforts to secure nominees to fill the wholesaler/retailer positions. As discussed in the proposed rule, the Board has made numerous attempts to nominate individuals to those positions; however, wholesalers and retailers are either not interested in or do not have the time to serve on the Board.

One commenter recommended that wholesalers and/or retailers be given full voting rights on the Board. The question of whether or not wholesaler/retailer members should be permitted to vote is not considered in this rule as it is not relevant given the Board's inability to find wholesalers and/or retailers to serve on the Board. The same commenter also suggested that the Board consider adding consumer members. Currently, all Board meetings are open to the public, and any person has the opportunity to contact the Board at any time. As such, consumer participation in Board activities does not require amendment of the Order.

One comment objecting to the regulation of mangos was outside the scope of this rule.

The Department has considered all of the comments and is not making any changes to the proposed rule.

After consideration of all relevant material presented, the Board's recommendation, public comments and other information, it is hereby found that this rule, as published in the Federal Register [76 FR 13530] on March 14, 2011, is consistent with and will effectuate the purpose of the Act.

For the reasons set forth in the preamble, 7 CFR part 1206 is amended as follows:

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on March 29, 2011 (76 FR 17364), and proposed to supersede AD 2010-02-02, Amendment 39-16173 (75 FR 1697, January 13, 2010). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

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

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

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a Note within the AD.

We estimate that this AD will affect about 24 products of U.S. registry.

The actions that are required by AD 2010-02-02 and retained in this AD take about 1 work-hour per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the currently required actions is $85 per product.

We estimate that it will take about 1 work-hour per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $2,040, or $85 per product.

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

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

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this AD:

1. Is not a ”significant regulatory action” under Executive Order 12866;

2. Is not a ”significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov ; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

On March 18, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to establish Class E airspace at Brunswick Executive Airport, Brunswick, ME (75 FR 14824) Docket No. FAA-2011-0116. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Subsequent to publication, a typographical error was found in the controlled airspace radius mileage. This action will make the correction.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR Part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.

This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface at Brunswick, ME to provide controlled airspace required to support the standard instrument approach procedures developed for Brunswick Executive Airport. This action is necessary for the safety and management of IFR operations at the airport. Brunswick Executive Airport uses the same facilities as the former Brunswick Naval Air Station (NAS), which closed in September 2010 (see 75 FR 57848).

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.

This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Brunswick, ME.

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

On April 12, 2011, the FAA published in the Federal Register a notice of proposed rulemaking to amend controlled airspace at Newcastle, WY (76 FR 20281). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9U dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace extending upward from 700 feet above the surface, at Mondell Field Airport, to accommodate IFR aircraft using the RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations. The airport name is being changed from Mondell Field, to Mondell Field Airport, Newcastle, WY. With the exception of minor corrections made to the regulatory text at the request of the FAA's Aeronautical Products Office, this rule is the same as that proposed in the NPRM.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes additional controlled airspace at Mondell Field Airport, Newcastle, WY.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows:

On July 21, 2010, President Barack Obama signed the Dodd-Frank Act into law. 1 The Dodd-Frank Act was enacted, among other reasons, to promote the financial stability of the United States by improving accountability and transparency in the financial system. 2 The recent financial crisis demonstrated the need for enhanced regulation of the over-the-counter (“OTC”) derivatives markets, which have experienced dramatic growth in recent years  3 and are capable of affecting significant sectors of the U.S. economy. 4 Title VII of the Dodd-Frank Act (“Title VII”) establishes a regulatory regime applicable to the OTC derivatives markets by providing the Commission and the Commodity Futures Trading Commission (“CFTC”) with the tools to oversee these heretofore largely unregulated markets. The Dodd-Frank Act provides that the CFTC will regulate “swaps,” the Commission will regulate “security-based swaps,” and the CFTC and the Commission will jointly regulate “mixed swaps.”  5

Title VII amends the Exchange Act  6 to substantially expand the regulation of the security-based swap (“SB swap”) markets, establishing a new regulatory framework within which such markets can continue to evolve in a more transparent, efficient, fair, accessible, and competitive manner. 7 The Dodd-Frank Act amendments to the Exchange Act impose, among other requirements, the following: (1) Registration and comprehensive oversight of SB swap dealers (“SBSDs”) and major SB swap participants (“MSBSPs” and, collectively with SBSDs, “SBS Entities”);  8 (2) reporting of SB swaps to a registered SB swap data repository (“SDR”), to the Commission, and to the public;  9 (3) clearing of SB swaps through a registered clearing agency or through a clearing agency that is exempt from registration  10 if such SB swaps are of a type that the Commission determines is required to be cleared, unless an exemption or exception from such mandatory clearing applies;  11 and (4) if an SB swap is subject to the clearing requirement, 12 execution of the SB swap transaction on an exchange, on an SB swap execution facility (“SB SEF”) registered under section 3D of the Exchange Act, 13 or on an SB SEF that has been exempted from registration by the Commission under section 3D(e) of the Exchange Act, 14 unless no SB SEF or exchange makes such SB swap available for trading. 15 Title VII also amends the Exchange Act and the Securities Act of 1933  16 (“Securities Act”) to include “security-based swaps” in the definition of “security” for purposes of those statutes. 17 As a result, “security-based swaps” will be subject to the provisions of the Securities Act and the Exchange Act and the rules thereunder applicable to “securities.”  18 The Commission has proposed exemptions  19 under the Securities Act, the Exchange Act, and the Trust Indenture Act of 1939  20 (“Trust Indenture Act”) for SB swaps issued by certain clearing agencies satisfying certain conditions. 21 In addition, the Commission will take other actions to address certain SB swaps, such as providing guidance regarding—and where appropriate, temporary relief from—the various pre-Dodd Frank Act provisions that would otherwise apply to SB swaps on July 16, 2011, as well as extending existing temporary rules under the Securities Act, the Exchange Act, and the Trust Indenture Act for certain SB swaps. 22

The provisions of Title VII generally are effective on July 16, 2011 (360 days after enactment of the Dodd-Frank Act, referred to herein as the “Effective Date”), unless a provision requires a rulemaking. Specifically, if a Title VII provision requires a rulemaking, such provision will not necessarily go into effect on the Effective Date, but instead will go into effect “not less than” 60 days after publication of the related final rule or on July16, 2011, whichever is later. 23 A substantial number of Title VII provisions require a rulemaking and thus will not go into effect on the Effective Date. A number of Title VII provisions also expressly (or implicitly) apply only to “registered” persons. Until the related registration processes for such persons have been established by final Commission rules, and such persons have become registered pursuant to such rules, they will not be required to comply with these Title VII provisions. 24 Other provisions of Title VII impose requirements that require compliance by market participants as a result of, or in response to, Commission action other than rulemaking and thus do not impose a compliance obligation upon market participants in the absence of such Commission action.

In addition, Title VII provides the Commission with flexibility to establish effective dates beyond the minimum 60 days specified therein for Title VII provisions that require a rulemaking. 25 Furthermore, as with other rulemakings under the Exchange Act, the Commission may set compliance dates (which may be later than the effective dates) for rulemakings under the Title VII amendments to the Exchange Act. Together, this provides the Commission with the ability to sequence the implementation of the various Title VII requirements in a way that effectuates the policy goals of Title VII while minimizing unnecessary disruption or costs.

Title VII also includes certain provisions that authorize or direct the Commission to take specified action that, once undertaken, may impose compliance obligations upon market participants. 26 These provisions will become effective on the Effective Date, but, by their plain language, pertain to Commission action. Accordingly, these provisions do not require compliance by market participants on the Effective Date unless the relevant Commission action already has been undertaken. The Commission does not expect to complete all of the rulemaking it is directed to carry out pursuant to these provisions prior to the Effective Date.

In furtherance of the Dodd-Frank Act's stated objective of promoting financial stability in the U.S. financial system, the Commission intends to move forward expeditiously with the implementation of the new SB swap requirements in an efficient manner, while minimizing unnecessary disruption and costs to the markets. The Commission recognizes that many market participants will find compliance with Title VII to be a substantial undertaking. SB swap markets already exist, are global in scope, and have generally grown in the absence of regulation in the United States and elsewhere. In addition, the SB swap markets are interconnected with other financial markets, including the traditional securities markets. In order to comply with Title VII provisions and related rules, the Commission recognizes that market participants will need additional time to acquire and configure necessary systems or to modify existing practices and systems, engage and train necessary staff, and develop and implement necessary policies and procedures. 27 Furthermore, some of these changes cannot be finalized until certain rules are effective. Accordingly, it is necessary or appropriate to defer some of these tasks until certain rules are effective, as more fully described below.

In order to effectuate the purposes of Title VII, and in response to comments received from market participants, 28 the Commission is providing guidance as to the provisions of the Exchange Act added by Title VII with which industry compliance will be required as of the Effective Date. 29

In addition, and for the reasons discussed in this Order, the Commission is granting temporary exemptive and other relief that is necessary or appropriate in the public interest, and consistent with the protection of investors, from compliance with certain of those provisions of the Exchange Act with which compliance would otherwise be required as of the Effective Date. Generally, section 36 of the Exchange Act authorizes the Commission to conditionally or unconditionally exempt, by rule, regulation, or order, any person, security, or transaction (or any class or classes of persons, securities, or transactions) from any provision or provisions of the Exchange Act or any rule or regulation thereunder, to the extent such exemption is necessary or appropriate in the public interest, and is consistent with the protection of investors. 30 This exemptive authority is not available for certain specified provisions of the Exchange Act that relate to SB swaps. 31 Where such exemptive authority is not provided, the Commission is using other available authority to provide appropriate temporary relief.

Section 3C of the Exchange Act, added by section 763(a) of the Dodd-Frank Act, generally provides that, if an SB swap is required to be cleared, it is unlawful for any person to engage in such SB swap unless that person submits such SB swap for clearing to a clearing agency that is registered under the Exchange Act or to a clearing agency that is exempt from registration under the Exchange Act. 32 Table A below lists each provision of section 3C of the Exchange Act and identifies those with which compliance will be required on the Effective Date and those with which compliance will be triggered by registration of a person as a clearing agency, adoption of final rules, or other action by the Commission. 33 For the provisions with which compliance will be required on the Effective Date, Table A notes whether temporary relief from compliance is granted. The rationale and duration for such relief is explained in the text following the table. The table also includes provisions that authorize or direct the Commission to take specified action that, once undertaken, may impose compliance obligations upon market participants. 34 Unless otherwise noted in the table below, these provisions do not require compliance by market participants on the Effective Date.

As indicated in Table A, the Commission is providing temporary exemptive relief from compliance with section 3C(e)(1) of the Exchange Act  49 for market participants with reporting obligations under section 13A of the Exchange Act. 50

Section 3C(e)(1) of the Exchange Act requires the Commission to adopt rules that provide that “[s]ecurity-based swaps entered into before the date of enactment of this section [(‘pre-enactment SB swaps’)] shall be reported to a registered security-based swap data repository or the Commission no later than 180 days after the effective date of [section 3C of the Exchange Act].”  51 Section 3C of the Exchange Act becomes effective on July 16, 2011, and 180 days after that date is January 12, 2012.

The Commission is exercising its authority under section 36 of the Exchange Act  52 to exempt any person from having to report any pre-enactment SB swaps as set forth in the rules adopted by the Commission pursuant to section 3C(e)(1) of the Exchange Act  53 until six (6) months after an SDR that is capable of accepting the asset class of the pre-enactment SB swaps is registered by the Commission. The Commission finds that such exemption is necessary or appropriate in the public interest, and is consistent with the protection of investors, because, even after an SDR is registered, market participants will need additional time to establish connectivity and develop appropriate policies and procedures to be able to deliver information to the registered SDR. Therefore, under this exemption, no person will be required to report a pre-enactment SB swap in an asset class until six (6) months after an SDR that is capable of accepting SB swaps in that asset class has registered with the Commission. 54

The Commission also is exercising its authority pursuant to section 36 of the Exchange Act to grant a temporary exemption from section 3C(g)(5)(B) of the Exchange Act. 55 Section 3C(g)(5)(B) of the Exchange Act  56 permits a counterparty to an SB swap that is not subject to the mandatory clearing requirement to elect to clear its SB swap with an SBS Entity. The Commission finds that it is necessary or appropriate in the public interest, and consistent with the protection of investors to grant a temporary exemption to SBS Entities from section 3C(g)(5)(B) of the Exchange Act  57 because the Commission understands that there are currently no CCPs offering customer clearing of SB swaps and additional action by the Commission will be necessary to address segregation and other customer protection issues. Therefore, under this exemption, section 3C(g)(5)(B) of the Exchange Act  58 will not apply until the earliest compliance date set forth in any of the final rules regarding section 3C(b) of the Exchange Act. 59

In addition, the Commission is exercising its authority pursuant to section 36 of the Exchange Act to grant temporary exemptions from sections 3C(j)(1) and (2) of the Exchange Act. 60 Section 3C(j)(1) of the Exchange Act  61 requires that each registered clearing agency designate an individual to serve as a chief compliance officer. The chief compliance officer will be required to comply with the duties specified in section 3C(j)(2) of the Exchange Act, 62 as well as, following rulemaking, the reporting provisions of section 3C(j)(3) of the Exchange Act. 63 The Commission finds that it is necessary or appropriate in the public interest, and consistent with the protection of investors to grant temporary exemptions from sections 3C(j)(1) and (2) of the Exchange Act  64 because there is potential uncertainty regarding the duties of a chief compliance officer as required by section 3C(j)(2). 65 Therefore, under this exemption, no person will be required to comply with section 3C(j)(1) or (2) of the Exchange Act  66 until the earliest compliance date set forth in any of the final rules regarding section 3C(j)(2) of the Exchange Act. 67

With respect to the remaining provisions of section 3C of the Exchange Act, unless and until the Commission makes a determination that an SB swap is required to be cleared, section 3C of the Exchange Act, by its terms, does not require any SB swap to be cleared through a registered clearing agency or a clearing agency that is exempt from registration. 68 The Commission is required to adopt rules for clearing agencies' submissions to the Commission for review of SB swaps that clearing agencies seek to accept for clearing. 69 Thus, no SB swaps will be required to be submitted to the Commission for review until the compliance date set forth in such rules.

• Are there other provisions of section 3C of the Exchange Act for which the Commission should grant temporary exemptive relief? Please specify which provisions and provide a detailed explanation of why granting such exemption would be necessary or appropriate in the public interest, and consistent with the protection of investors.

Section 3D of the Exchange Act, added by section 763(c) of the Dodd-Frank Act, contains the provisions regarding the registration of SB SEFs and the core principles with which registered SB SEFs must comply. 70 Table B below lists each provision of section 3D of the Exchange Act and identifies those with which compliance will be required on the Effective Date and those with which compliance will be triggered by registration of a person as a SB SEF, adoption of final rules, or other action by the Commission. 71 For the provisions with which compliance will be required on the Effective Date, Table B notes whether temporary relief from compliance is granted. The rationale and duration for such relief is explained in the text following the table. The table also includes provisions that authorize or direct the Commission to take specified action that, once undertaken, may impose compliance obligations upon market participants. Unless otherwise noted in the table below, these provisions do not require compliance by market participants on the Effective Date.

As indicated in Table B, the Commission finds, pursuant to section 36 of the Exchange Act, 77 that it is necessary or appropriate in the public interest, and is consistent with the protection of investors, to grant temporary exemptions from sections 3D(a)(1) and 3D(c) of the Exchange Act. 78 Section 3D(a)(1) of the Exchange Act states that no person may operate a facility for the trading or processing of SB swaps unless the facility is registered as a SB SEF or as a national securities exchange under section 3D of the Exchange Act. 79 The temporary exemption from section 3D(a)(1) would allow an entity that trades SB swaps and is not currently registered as a national securities exchange, or that cannot yet register as a SB SEF because final rules for such registration have not yet been adopted, 80 to continue trading SB swaps during this temporary period without registering as a national securities exchange or SB SEF. 81 The Commission finds that such action is necessary or appropriate in the public interest, and consistent with the protection of investors, to facilitate the operation of entities that trade SB swaps so that these instruments can continue to be traded without the need for entities that trade such instruments to register as national securities exchanges before the Commission has put in place a registration regime for SB SEFs, at which time the entities that operate these facilities would be able to choose between registration as a national securities exchange and a SB SEF.

Section 3D(c) of the Exchange Act requires that a national securities exchange (to the extent that it also operates an SB SEF and uses the same electronic trade execution system for listing and executing trades of SB swaps on or through the exchange and the facility) identify whether electronic trading of such SB swaps is taking place on or through the national securities exchange or the SB SEF. 82 The temporary exemption from section 3D(c) of the Exchange Act  83 would avoid legal uncertainty regarding whether a national securities exchange is operating as a SB SEF until further guidance is available.

The temporary exemptions from sections 3D(a)(1) and 3D(c) of the Exchange Act  84 will expire on the earliest compliance date set forth in any of the final rules regarding registration of SB SEFs.

• Are there other provisions of section 3D of the Exchange Act for which the Commission should grant temporary exemptive relief? Please provide a detailed explanation of why granting such an exemption would be necessary or appropriate in the public interest, and consistent with the protection of investors.

Section 3E of the Exchange Act, added by section 763(d) of the Dodd-Frank Act, regulates the collection and handling of collateral that counterparties to SB swaps deliver to secure their obligations arising from such SB swaps and sets out certain rights of the counterparties who deliver such collateral. 85 Certain of these provisions require rulemaking by the Commission and thus will not require compliance on the Effective Date because the Commission will not have adopted a segregation rule by that date. Table C below lists each provision of section 3E of the Exchange Act and identifies those provisions that will require compliance on the Effective Date and those with which compliance will be triggered by the adoption of final rules or other action by the Commission. 86 For the provisions with which compliance will be required on the Effective Date, Table C notes whether temporary relief from compliance is granted. The rationale and duration for such relief is explained in the text following the table.

As indicated in Table C, the Commission is granting temporary exemptions from compliance with section 3E(f) of the Exchange Act for SBS Entities. 95 Section 3E(f) of the Exchange Act requires SBS Entities to segregate initial margin amounts delivered by their counterparties in uncleared SB swap transactions if requested to do so by such counterparties. 96 Such segregation would require the establishment of accounts in which to segregate collateral with independent third-party custodians. 97 The establishment of these accounts and the adoption of policies and procedures setting forth the proper collection and maintenance of collateral will require expenditures of resources and time. 98

The Commission finds that temporary exemption from section 3E(f) of the Exchange Act for SBS Entities is necessary or appropriate in the public interest, and is consistent with the protection of investors, because it would allow persons to register as an SBS Entity in accordance with the applicable registration requirements, once established, prior to expending resources to comply with the provisions of section 3E(f) of the Exchange Act as discussed above. 99 In addition, the Commission believes the exemption will give SBS Entities additional time to establish the necessary accounts and adopt the policies and procedures required by section 3E(f) of the Exchange Act. 100 Accordingly, the Commission is providing a temporary exemption pursuant to section 36 of the Exchange Act  101 from section 3E(f) of the Exchange Act  102 for SBS Entities. The temporary exemption will expire on the date upon which the rules adopted by the Commission to register SBSDs and MSBSPs become effective.

Section 3E(a) of the Exchange Act prohibits a person not registered as a broker, dealer, or SBSD from undertaking specified actions pertaining to the collection of margin associated with clearing an SB swap for an SB swap customer through a clearing agency. 103 Section 3E(a) of the Exchange Act requires that a person register with the Commission as a broker, dealer, or SBSD in order to comply with the provision. 104 Section 3E(b) of the Exchange Act obligates such persons to segregate initial margin amounts delivered by their counterparties in cleared SB swaps. 105 Sections 3E(c), (d), and (e) of the Exchange Act, 106 respectively, contain exceptions to section 3E(b) of the Exchange Act  107 permitting the commingling of funds for convenience in certain circumstances, prescribe certain obligations of the United States government in which margin collected may be invested, and contain other prohibitions on the use of margin.

The Commission is not granting exemptions from the requirements of sections 3E(a), (b), (c) or (e) of the Exchange Act. 108 Based on the Commission's experience in granting, and representations made by recipients of, previous exemptive orders for CCPs, the Commission understands that there are currently no CCPs offering customer clearing of SB swaps. 109 However, for CCPs that are planning to offer customer clearing of SB swaps before the compliance date for any of the final rules regarding registration of SBS Entities, the Commission will consider requests for relief from such CCPs on behalf of their participants from sections 3E(a), (b), and (e) of the Exchange Act, as appropriate, based on the applicable facts and circumstances. 110

• Under the stock-broker bankruptcy provisions of the Bankruptcy Code, 111 the description of which persons have the status as a customer of a broker-dealer with respect to their posted margin includes persons whose margin is required to be segregated. Given that reference to a segregation requirement, is any temporary exemption from section 3E(f) of the Exchange Act appropriate?

• Please explain the steps that must be taken for an SBSD to segregate initial margin for uncleared SB swap transactions. How long would it take to put in place such an arrangement with an independent third-party custodian? Would any existing documentation between the parties need to be amended?

• Are there other provisions of section 3E of the Exchange Act for which the Commission should consider granting a temporary exemption? Please specify the provision or provisions for which exemptions should be granted and provide a detailed explanation of why granting such exemptions would be necessary or appropriate in the public interest, and consistent with the protection of investors.

Section 9(j) of the Exchange Act, 112 added by 763(g) of the Dodd-Frank Act, includes a provision regarding the prevention of fraud, manipulation, and deception in connection with SB swaps. As indicated in Table D below, section 9(j) of the Exchange Act requires rulemaking. 113

FDA is announcing the availability of a guidance for small business entities entitled “Topical Acne Drug Products for Over-the-Counter Human Use—Revision of Labeling and Classification of Benzoyl Peroxide as Safe and Effective; Small Entity Compliance Guide.” This guidance summarizes the March 4, 2010, final rule regarding topical acne drug products for OTC use that makes the following changes to the OTC regulations:

• Adds benzoyl peroxide as a GRASE active ingredient in OTC topical acne drug products.

• Sets forth new warnings and a direction that must be included in labeling of OTC topical acne drug products that contain benzoyl peroxide.

• Revises labeling requirements for all OTC topical acne drug products to ensure consistency with the standardized drug facts formatting and requirements set forth in § 201.66 (21 CFR 201.66).

The guidance summarizes in table form the requirements for specific warnings and directions in the labeling that apply to all OTC acne drug products marketed under the monograph ( i.e., products that contain any of the active ingredients permitted under the OTC topical acne drug monograph, including benzoyl peroxide, resorcinol, resorcinol monoacetate, salicylic acid, and/or sulfur) (21 CFR part 333, subpart D)). The summaries include new warnings and a new “direction for use” required specifically for OTC topical acne products that contain benzoyl peroxide. The revised labeling requirements ensure that the labeling of OTC topical acne drug products is consistent with the standardized drug facts labeling content and format requirements in § 201.66.

FDA is issuing this small entity compliance guide as level 2 guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on the classification of benzoyl peroxide as GRASE in the OTC topical acne drug monograph, and revised labeling requirements for OTC topical acne products, as set forth in the final rule. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov .

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 delaying the effective date would be contrary to the public interest since immediate action is needed to ensure the safety of the event participants, patrol vessels, spectator craft and other vessels transiting the event area. The potential dangers posed by hydroplane speed boats, operating in speeds excess of 150 miles per hour, make special local regulations necessary. However, the Coast Guard will provide advance notifications to users of the effected waterways via marine information broadcasts, local notice to mariners, commercial radio stations and area newspapers. This regulation represents the re-scheduling of the event in order to de-conflict the event from another race that many competitors and a sponsor are involved in during the second weekend in August 2011 and to have the event take place close in time to the regularly scheduled dates of the event. In addition, publishing an NPRM is unnecessary because this event is an annual event which mariners should be aware of taking place, as it is noticed in the Federal Register . If mariners had concerns about this event taking place, they are on notice throughout the year of the event and can object to or comment about the event at any time. When the NPRM, including the table to § 100.501 listing all of the annual events, was made available for comment, there were no objections to this event.

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 the effective date would be contrary to the public interest since immediate action is needed to ensure the safety of the event participants, patrol vessels, spectator craft and other vessels transiting the event area. The potential dangers posed by hydroplane speed boats, operating in speeds excess of 150 miles per hour, make special local regulations necessary. However, the Coast Guard will provide advance notifications to users of the effected waterways via marine information broadcasts, local notice to mariners, commercial radio stations and area newspapers. This regulation represents the re-scheduling of the event in order to de-conflict the event from another race that many competitors and a sponsor are involved in during the second weekend in August 2011 and to have the event take place close in time to the regularly scheduled dates of the event. In addition, publishing an NPRM is unnecessary because this event is an annual event which mariners should be aware of taking place, as it is noticed in the Federal Register . If mariners had concerns about this event taking place, they are on notice throughout the year of the event and can object to or comment about the event at any time. When the NPRM, including the table to § 100.501 listing all of the annual events, was made available for comment, there were no objections to this event.

This event is annually held in August, scheduled to begin on the second Friday of August and anticipated to run through the Saturday and Sunday of that weekend. The regulation listing annual marine events within the Fifth Coast Guard District and their regulated dates is 33 CFR 100.501. A table to § 100.501 identifies marine events by Captain of the Port zone. This particular event, sponsored this year by the City of Hampton, Hampton Cup Regatta Racing Club and the Phoebus Civic Association, is listed at line No. 44.

This year, the Regatta was initially scheduled to take place on August 12-14, 2011. However, the event was rescheduled to take place one week earlier, on August 6-7, 2011. The date has changed due to participants and a sponsor being involved in another race during the second weekend in August. In order to deal with this conflict, the regatta date was pushed up one weekend in August 2011.

On August 6-7, 2011, the City of Hampton, Hampton Cup Regatta Racing Club and the Phoebus Civic Association will sponsor the “85th Hampton Cup Regatta” in the waters of Mill Creek, adjacent to Fort Monroe, Hampton, Virginia. The event will consist of approximately 75-100 hydroplane powerboats conducting high-speed competitive races in heats counter-clockwise around an oval racecourse on the water of the Mill Creek adjacent to Fort Monroe, Hampton, Virginia and Route 258 Mercury Highway Bridge. A fleet of spectator vessels is expected to gather near the event site to view the competition. Due to the need for vessel control during the event, the Coast Guard will temporarily restrict vessel traffic in the event area to provide for the safety of participants, spectators, and other transiting vessels. The special local regulation will be enforced from 11:30 a.m. to 5 p.m. August 6, 2011 and from 11:30 a.m. to 5 p.m. on August 7, 2011.

During this enforcement period, vessels may not enter the regulated area unless they receive permission from the Coast Guard Patrol Commander.

The Coast Guard will temporarily suspend the regulation listed at line No. 44 in Table to § 100.501 and will insert this new temporary regulation at Table to § 100.501 line No. 44a, in order to reflect the change in date for this event this year. This change is needed to accommodate the conflict in races during the second weekend in August 2011; because there is another race that many participants and a sponsor are involved with during the second week of August 2011, it was determined to shift the “85th Hampton Cup Regatta” to the first weekend in August 2011. No other portion of the Table to § 100.501 shall be affected by this regulation.

This special local regulation will restrict navigation in the regulated area during the marine event, from 11:30 a.m. to 5 p.m. on August 6, 2011 and from 11:30 a.m. to 5 p.m. on August 7, 2011. Except for persons or vessels authorized by the Coast Guard Patrol Commander, no person or vessel may enter or remain in the regulated area during the effective period. The regulated area is needed to control vessel traffic during the event to enhance the safety of participants in and spectators to the 85th Hampton Cup Regatta.

The enforcement period for this special local regulation will be from 11:30 a.m. to 5 p.m. on August 6, 2011 and from 11:30 a.m. to 5 p.m. on August 7, 2011. The Coast Guard, at its discretion, will allow the passage of vessels when races are not taking place. Except for participants and vessels authorized by the Captain of the Port or his Representative, no person or vessel may enter or remain in the regulated area.

In addition to notice in the Federal Register , the maritime community will be provided advance notification via the Local Notice to Mariners and marine information broadcasts.

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, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under that those Orders. Although this rule prevents traffic from transiting a portion of certain waterways during specified events, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, local radio stations and area newspapers so mariners can adjust their plans.

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.

The rule would affect the following entities, some of which might be small entities: the owners or operators of vessels intending to transit or anchor in this section of Mill Creek during the event from 11:30 a.m. to 6 p.m. on August 6 and from 11:30 a.m. to 6 p.m. on August 7, 2011.

Although this regulation prevents traffic from transiting a portion of Mill Creek during the event, this rule would not have a significant economic impact on a substantial number of small entities for the following reasons. This rule would be in effect for only a limited period. Vessel traffic will be able to transit the regulated area between heats, when the Coast Guard Patrol Commander deems it is safe to do so. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

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

Under 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 which do not individually or cumulatively have a significant effect on the human environment. This rule is categorically excluded, under figure 2-1, paragraph (34)(h), of the Instruction. This rule involves implementation of regulations within 33 CFR Part 100 that apply to organized marine events on the navigable waters of the United States that may have potential for negative impact on the safety or other interest of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, and sail board racing. Under figure 2-1, paragraph (34)(h), of the Instruction, an environmental analysis checklist and a categorical exclusion determination will be available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

Regulatory Information

On April 13, 2011, we published a notice of proposed rulemaking (NPRM) entitled: Special Local Regulation; Extreme Sailing Series Boston; Boston Harbor, Boston, Massachusetts, in the Federal Register (76 FR 20595). We received one comment on the proposed rule. No public meeting was requested, and none was held.

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 . The Coast Guard completed the public comment period for this rule and only received one comment on the rule which was positive in nature. The sponsor is unable to reschedule this event due the vast number of participants, scheduling, and to other activities being held in conjunction with the event. Establishing a special local regulation for the event will help ensure the safety of persons and property and minimize the associated risks by controlling vessel traffic and movement.

The legal basis for this rule is 33 U.S.C. 1233, which authorizes the Coast Guard to define Special Local Regulations.

Establishing a special local regulation for the event will help ensure the safety of persons and property and minimize the associated risks by controlling vessel traffic and movement.

This temporary special local regulation is necessary to ensure the safety of vessels, participants, and the public during the Extreme Sailing Series Boston regatta. The event will take place over the course of five days in Boston Harbor in the vicinity of Fan Pier. There will be two regulated areas associated with this event and they will be enforced immediately before, during, and after the regatta, from June 30th through July 4th, 2011, from 1 p.m. to 6 p.m. daily.

This rule is necessary to ensure the safety of vessels and spectators from the hazards associated with competitive sailing regattas. Without the rule, the combination of a large number of recreational vessels due to spectators, sailboats traveling at high speeds on the race course, and large numbers of spectators on the adjacent Fan Pier in close proximity to the water and in a small area of water, could easily result in serious injuries or fatalities.

All persons and vessels shall comply with the instructions of the COTP Boston or the designated on-scene representative. Entering into, transiting through, mooring or anchoring within the special local regulation area is prohibited unless authorized by the COTP Boston or the designated on-scene representative.

We received one comment and no changes have been made to the proposed rule.

The Boston Harbor Association, a non-profit, public interest organization, stated they attended two meetings regarding the plans for the Extreme Sailing Series. Having been at both meetings, the Boston Harbor Association believes that the proposed regulation restricting access to a portion of the waterway addresses the concerns discussed at the meetings, and write in support of the regulation as drafted. The Boston Harbor Association commends all parties for working together to promote activities which allow the public to enjoy Boston Harbor and the waterfront while minimizing impacts to port commerce and commercial boat operators.

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, as supplemented by Executive Order 13563, 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 determined that this rule is not a significant regulatory action for the following reasons: (1) The rule will be in effect for five hours per day for five days; (2) persons and vessels may still enter, transit through, anchor in, or remain within the regulated area if they obtain permission from the COTP or the designated representative; and (3) advance notification will be made to the maritime community via broadcast notice to mariners and Local Notice to Mariners (LNM).

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 enter, transit through, anchor in or remain within this regulated area during periods of enforcement.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: This rule will be enforced for a short duration and the race area within the Special Local Regulation area can be quickly collapsed at the discretion of the COTP, as necessary to allow for certain vessels greater than 65 feet in length to transit, provided the vessels have given a five-hour advance notice of their intended transit to the COTP. All other vessels not required to provide advance notification may transit within the Special Local Regulation area, with the exception of the race area, at all times while following the regulations in this rule.

Additionally, the race organizers will coordinate with industry and the Boston Pilots to provide minimal interruption of commercial vessel traffic during the enforcement periods.

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

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 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 that 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)(h), of the Instruction. This rule involves the establishment of a special local regulation. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

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 publishing a NPRM would be impracticable since immediate action is needed to protect the general public, levee system, vessels and tows from the hazards associated with rising flood water.

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 . Providing 30 days notice and delaying its effective date would be impracticable since immediate action is needed to protect the general public, levee system, vessels and tows from destruction, loss or injury due to the hazards associated with rising flood water.

Captain of the Port Morgan City, Louisiana has determined that there is a need to impose temporary safety restrictions for navigation on certain waterways due to unprecedented high water in conjunction with flood control and protection operations by the Army Corps of Engineers.

The Coast Guard is establishing a temporary safety zone imposing restrictions on the Gulf Intracoastal Waterway (GIWW) between West Harvey Lock Gulf West (WHL) mile markers (MM) 98.5 to 108.5 applicable to all commercial traffic. This will affect all East-West traffic through Morgan City on the GIWW. Vessels and tows may not enter this zone unless authorized by the Captains of the Port Morgan City.

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 will restrict access to the area, the effect of the rule will not be significant because notifications to the marine community will be made through broadcast notice to mariners, Local Notice to Mariners and Marine Safety Information Bulletins. Vessels and tows may request permission and comply with the necessary restrictions from the Captain of the Port Morgan City, or a designated representative, for passage through the temporary safety zone. Passage through the safety zone will be evaluated on a case-by-case-basis to minimize impact and protect the general public, levee system, vessels and tows from destruction, loss or injury due to the hazards associated with rising flood water.

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 through the safety zone from May 26, 2011 through July 31, 2011. This safety zone is not expected to have a significant economic impact on a substantial number of small entities because vessels and tows may request permission and the necessary restrictions from the Captain of the Port Morgan City, or a designated representative, for passage through the temporary safety zone.

If you are a small business entity and are significantly affected by this regulation, please contact LT Russell Pickering, Marine Safety Unit Morgan City, at (985) 380-5334.

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 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and 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 which 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 an emergency situation and will be in effect for over one week, but is not expected to result in any significant adverse environmental impact as described in NEPA.

An environmental analysis checklist and a categorical exclusion determination will be provided and made available at the docket as indicated in the ADDRESSES section.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

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 using the NPRM process. The Coast Guard received minimal notice that the Marine Corps demonstration, which did not allow for the time needed to publish a NPRM and provide for a comment period. Delaying this rule by publishing a NPRM would be impracticable and unnecessarily delay the scheduled demonstration. This rule is needed to protect vessels and mariners from the safety hazards associated with such a demonstration.

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 . The Coast Guard received minimal notice that the Marine Corps demonstration, which did not allow for a 30-day notice period. Delaying this rule by providing 30 days notice would be impracticable and unnecessarily delay the scheduled demonstration. Delaying the rule's effective date would be impracticable because immediate action is needed to protect vessels and mariners from the safety hazards associated with a demonstration of Marine Corps combat capabilities.

From June 23 through June 25, 2011 the USMC 3rd Battalion, 24th Marines will conduct a series of demonstrations of Marine Corps combat capabilities between Mile 180.0 and 179.0 on the Upper Mississippi River. This event presents safety hazards to the navigation of vessels between Mile 180.0 and 179.0, extending the entire width of the river. To provide for the safety of the public, the Coast Guard will temporarily restrict access to this section of the Upper Mississippi River during the scheduled demonstrations.

The Coast Guard is establishing a temporary safety zone for all waters of the Upper Mississippi River, Mile 180.0 to 179.0, extending the entire width of the river. Entry into this zone is prohibited to all vessels and persons except participants and those persons and vessels specifically authorized by the Captain of the Port Upper Mississippi River. This rule is effective from 12 noon on June 23, 2011 through 6 p.m. CDT on June 25, 2011. This rule will be enforced from 3:30 p.m. until 5 p.m. CDT on June 23 and 24, 2011, and 1:30 p.m. until 3 p.m. CDT on June 25, 2011. The Captain of the Port Upper Mississippi River will inform the public through broadcast notice to mariners of all safety zone requirements changes and enforcement periods.

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 will restrict access to this area, the effect of the rule is not significant because: (1) This rule will be in effect for a limited time period and notifications to the marine community will be made through local notice to mariners; and (2) vessels may be permitted to transit the area by the Captain of the Port Upper Mississippi River or designated representative.

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 Upper Mississippi River, Mile 180.0 to 179.0 after 12 noon on June 23, 2011 through 6 p.m. CDT on June 25, 2011. This safety zone will not have a significant economic impact on a substantial number of small entities because this rule will only be in effect for a limited period of time.

If you are a small business entity and are significantly affected by this regulation, please contact Chief Petty Officer Bryan Klostermeyer, Sector Upper Mississippi River at (314) 269-2566.

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 businesses. 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 or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

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

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

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

The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through the Office of Management and Budget, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., specifications of materials, performance, design, or operation; test methods; sampling procedures; and related management systems practices) that are developed or adopted by voluntary consensus standards bodies. This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this rule under 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 which 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 temporary safety zone to protect the public from the dangers associated with the scheduled demonstrations of Marine Corps combat capabilities. An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

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 publishing a NPRM would be impracticable since immediate action is needed to protect the general public, levee system, vessels and tows from the hazards associated with rising flood water on the Morgan City-Port Allen Route.

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 . Publishing a NPRM and delaying its effective date would be impracticable since immediate action is needed to protect the general public, levee system, vessels and tows from destruction, loss or injury due to the hazards associated with rising flood water on the Morgan City-Port Allen Route.

Captains of the Port Morgan City and New Orleans, Louisiana have determined that there is a need to close certain waterways contingent on the predicted river heights and currents. This temporary safety zone is needed to protect the general public, levee system, vessels and tows from destruction, loss or injury from flood waters and associated hazards.

The Coast Guard is establishing a temporary safety zone on the specified waters of the Gulf Intracoastal Water Way on the Morgan City-Port Allen Route from MM 0 to the Port Allen lock. Commercial vessels and tows may not enter this zone unless authorized by the Captains of the Port Morgan City or New Orleans.

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 will restrict access to the area, the effect of the rule will not be significant because notifications to the marine community will be made through broadcast notices to mariners and Local Notices to Mariners and Marine Safety Information Bulletins. Vessels requiring entry into or passage through the temporary safety zone may request permission from the Captains of the Port Morgan City or New Orleans, or a designated representative and entry will be evaluated on a case-by-case-basis to minimize impact and protect the general public, levee system, vessels and tows from destruction, loss or injury due to the hazards associated with rising flood water.

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 through the temporary safety zone from May 16, 2011 through July 31, 2011. This temporary safety zone is not expected to have a significant economic impact on a substantial number of small entities because vessels requiring entry into or passage through the temporary safety zone may request permission from the Captains of the Port Morgan City or New Orleans, or a designated representative.

If you are a small business entity and are significantly affected by this regulation, please contact LT Russell Pickering, Marine Safety Unit Morgan City, at (985) 380-5334.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 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 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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

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

We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and 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 which 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 an emergency situation and will be in effect for over one week, but is not expected to result in any significant adverse environmental impact as described in NEPA.

An environmental analysis checklist and a categorical exclusion determination will be provided and made available at the docket as indicated in the ADDRESSES section.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

On March 15, 2011, the Postal Service published and requested comments concerning a proposed revision of 39 CFR part 952, concerning the rules of practice in proceedings relative to false representation and lottery orders (76 FR 13937-13944). The proposed rules of procedure were intended to have the same general coverage as the existing rules. The proposed new rules, however, were updated, were more comprehensive than the existing rules, and were intended to reflect more precisely current practice. No comments were received in response to this request.

Accordingly, the Postal Service has determined to adopt the revision of 39 CFR part 952 as proposed, with minor non-substantive changes in paragraphing and punctuation. The revised rules will completely replace the existing rules of practice, and in accordance with section 952.2 will apply to all formal proceedings before the Postal Service under 39 U.S.C. 3005, including such cases instituted under prior rules of practice.

For the reasons stated in the preamble, the Postal Service revises 39 CFR part 952 to read as follows:

I. Background

On March 4, 2011, the Commonwealth of Virginia submitted a formal revision to its SIP. The SIP revision consists of amendments pertaining to the ambient air quality standards for NO 2 and related reference conditions. The CAA specifies that EPA must re-evaluate the appropriateness of its various air quality standards every five years. As part of the process, EPA reviewed the latest research and determined that revised standards for NO 2 were necessary to protect public health. EPA revised the level of the primary standard by setting a new 1-hour NO 2 standard at a level of 100 parts per billion (ppb) in order to protect against adverse health effects associated with short-term exposure to NO 2 . EPA also retained the current annual average NO 2 standard of 53 ppb in order to protect against adverse health effects associated with long-term exposure to NO 2 . EPA promulgated the more stringent primary NAAQS for NO 2 on February 9, 2010 (75 FR 6474).

On March 4, 2011, the Commonwealth of Virginia submitted a formal revision to its SIP. The SIP revision consists of amendments to the Commonwealth's existing regulations in order to update the list of appendices under documents incorporated by reference and to add the new primary 1-hour standard for NO 2 . The Commonwealth of Virginia's revision incorporates the revised NO 2 standard into the Code of Virginia (9VAC5 Chapter 30). This SIP revision amends regulation 5-30-70, “Oxides of nitrogen with nitrogen dioxide as the indicator” in order to specify that NO 2 is the indicator for oxides of nitrogen; limit the 53 ppb standard to the annual primary standard and change the unit of measurement from annual arithmetic mean concentration to annual average concentration; add the new primary 1-hour standard of 100 ppb; specify reference methods used to measure the standard; and specify how the primary annual and 1-hour standard and the secondary standard are attained.

In addition, this SIP revision amends regulation 5-20-21, “Documents incorporated by reference” by adding the new Appendix S to the list of Federal documents incorporated by reference. Appendix S was added to 40 CFR part 50 when the revised NO 2 standard was promulgated on February 9, 2010 (75 FR 6474).

In 1995, Virginia adopted legislation that provides, subject to certain conditions, for an environmental assessment (audit) “privilege” for voluntary compliance evaluations performed by a regulated entity. The legislation further addresses the relative burden of proof for parties either asserting the privilege or seeking disclosure of documents for which the privilege is claimed. Virginia's legislation also provides, subject to certain conditions, for a penalty waiver for violations of environmental laws when a regulated entity discovers such violations pursuant to a voluntary compliance evaluation and voluntarily discloses such violations to the Commonwealth and takes prompt and appropriate measures to remedy the violations. Virginias Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-1198, provides a privilege that protects from disclosure documents and information about the content of those documents that are the product of a voluntary environmental assessment. The Privilege Law does not extend to documents or information (1) that are generated or developed before the commencement of a voluntary environmental assessment; (2) that are prepared independently of the assessment process; (3) that demonstrate a clear, imminent and substantial danger to the public health or environment; or (4) that are required by law.

On January 12, 1998, the Commonwealth of Virginia Office of the Attorney General provided a legal opinion that states that the Privilege Law, Va. Code Sec. 10.1-1198, precludes granting a privilege to documents and information “required by law,” including documents and information “required by Federal law to maintain program delegation, authorization or approval,” since Virginia must “enforce Federally authorized environmental programs in a manner that is no less stringent than their Federal counterparts. * * *” The opinion concludes that “[r]egarding § 10.1-1198, therefore, documents or other information needed for civil or criminal enforcement under one of these programs could not be privileged because such documents and information are essential to pursuing enforcement in a manner required by Federal law to maintain program delegation, authorization or approval.”

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.”

Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law.

EPA is approving the Commonwealth of Virginia's SIP revision that adds the new 1-hour NO 2 NAAQS and updates the list of Federal documents incorporated by reference. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment. However, in the Proposed Rules section of today's Federal Register , EPA is publishing a separate document that will serve as the proposal to approve the SIP revision if adverse comments are filed. This rule will be effective on August 22, 2011 without further notice unless EPA receives adverse comment by July 22, 2011. If EPA receives adverse comment, EPA will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. EPA will address all public comments in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this rule does not have Tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on Tribal governments or preempt Tribal law.

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 22, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action pertaining to the Commonwealth of Virginia's adoption of the revised NO 2 standard of 100 ppb may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

Definitions

For the purpose of this document, we are giving meaning to certain words or initials as follows:

(i) The words or initials Act, CAA, or Clean Air Act mean or refer to the Clean Air Act, unless the context indicates otherwise.

(ii) The words EPA, we, us or our mean or refer to the United States Environmental Protection Agency.

(iii) The initials SIP mean or refer to State Implementation Plan.

(iv) The words Idaho and State mean the State of Idaho.

On July 18, 1997, EPA promulgated new NAAQS for 8-hour ozone and for fine particulate matter (PM 2.5 ). This action is being taken, in part, in response to the promulgation of the 1997 8-hour ozone and PM 2.5 NAAQS. Section 110(a)(1) of the CAA requires states to submit a SIP revision to address a new or revised NAAQS within 3 years after promulgation of such standards, or within such shorter period as EPA may prescribe. Section 110(a)(2) lists the elements that such new SIPs must address, as applicable, including section 110(a)(2)(D)(i), which pertains to interstate transport of certain emissions.

Section 110(a)(2)(D)(i) of the CAA requires that a SIP must contain adequate provisions prohibiting any source or other type of emissions activity within the state from emitting any air pollutant in amounts which will: (1) contribute significantly to nonattainment of the NAAQS in any other state; (2) interfere with maintenance of the NAAQS by any other state; (3) interfere with any other state's required measures to prevent significant deterioration of air quality; or (4) interfere with any other state's required measures to protect visibility. This action addresses the fourth prong, section 110(a)(2)(D)(i)(II).

In the CAA Amendments of 1977, Congress established a program to protect and improve visibility in the national parks and wilderness areas. See CAA section 169(A). Congress amended the visibility provisions in the CAA in 1990 to focus attention on the problem of regional haze. See CAA section 169(B). EPA promulgated regulations in 1999 to implement sections 169A and 169B of the Act. These regulations require states to develop and implement plans to ensure reasonable progress toward improving visibility in mandatory Class I Federal areas 1 (Class I areas). 64 FR 35714 (July 1, 1999); see also 70 FR 39104 (July 6, 2005) and 71 FR 60612 (October 13, 2006).

On October 25, 2010, the State of Idaho submitted to EPA a State Implementation Plan (SIP) revision addressing the interstate transport requirements for visibility for the 1997 ozone and PM 2.5 NAAQS, [see CAA § 110(a)(2)(D)(i)(II)], and the requirements of the regional haze program at 40 CFR § 51.308 (Regional Haze SIP submittal). On January 11, 2011, EPA published a notice in which the Agency proposed to approve the Idaho SIP revision as meeting the requirements of both section 110(a)(2)(D)(i)(II) of the CAA and the Regional Haze requirements set forth in sections 169A and 169B of the CAA and in 40 CFR 51.300-308, with the exception of Chapter 11, Idaho Reasonable Progress Goal Demonstration and Chapter 12, Long Term Strategy. 76 FR 1579 (Notice of Proposed Rulemaking or NPR). For Idaho's Reasonable Progress Goal Determination and Long-Term Strategy, EPA did not propose taking any action.

EPA received four comments on the proposed action to approve certain elements of the Idaho Regional Haze SIP submittal. A comment letter was received from the State of Idaho's Department of Environmental Quality (IDEQ). A comment was received from a private citizen. Adverse comments were received by two entities; The Amalgamated Sugar Company (TASCO) and the Wyoming Outdoor Council. The discussion below summarizes and responds to the comments received on EPA's proposed SIP action and explains the basis for EPA's final action.

Comment: IDEQ's letter related to a Tier II operating permit IDEQ had issued to The Amalgamated Sugar Company (TASCO) on September 7, 2010, that included the requirement to install and operate BART control technology and comply with the BART emission limitations. See the September 7, 2010, letter from IDEQ to TASCO issuing the Tier II Operating Permit No. T2-2009-0105, that was included in the Idaho Regional Haze SIP submittal. The comment explained that on October 12, 2011, TASCO appealed the Tier II permit and that IDEQ has entered into negotiations with TASCO to discuss alternative control measures that may be required at the TASCO Nampa facility in lieu of the BART conditions as outlined in the SIP submission. IDEQ and TASCO hope these negotiations will result in a revised Tier II permit, agreed to by both parties, that results in emissions controls that can be considered better than the BART currently in the SIP submission.

Response: EPA acknowledges the notification.

Comment: The comment supports Idaho's actions to improve visibility in Class I areas.

Response: EPA acknowledges the comment.

Comment 1a: TASCO requests the EPA defer further action of the Regional Haze SIP submittal. TASCO explains that it is actively negotiating with IDEQ to resolve its challenge to IDEQ's Tier II operating permit that was issued on September 7, 2010, imposing BART controls on the Riley Boiler at the TASCO Nampa facility. TASCO is hopeful that the negotiations will result in a revised BART determination and revised Tier II operating permit by May 2, 2011. Thus, in the commenter's view, final action on the TASCO portion of the Regional Haze SIP is premature, would ignore the ongoing negotiations between TASCO and IDEQ, and would cause unnecessary administrative burden for EPA, IDEQ, and TASCO because the company expects that a new/revised Tier II permit will be negotiated, issued and submitted to EPA. The commenter urges EPA to postpone final action on the Regional Haze SIP submittal pending the outcome of ongoing negotiations between TASCO and IDEQ and until EPA undertakes a complete reevaluation of the affordability of BART controls. 2

Response: TASCO suggests that instead of acting on the Regional Haze SIP submittal, EPA defer action until the ongoing negotiations between IDEQ and TASCO are completed and a revised BART determination for TASCO is submitted to EPA. Unfortunately, EPA cannot defer action on the Regional Haze SIP submittal. States were required to submit Regional Haze SIPs by December 17, 2007. As Idaho and a number of other states failed to meet this deadline, EPA issued a final rule finding that these states had failed to submit Regional Haze SIPs to EPA. 74 FR 2392 (January 15, 2009). Under the CAA, EPA must issue a Federal implementation plan (FIP) within two years of finding that a state has failed to make a required submission, unless the state submits a SIP and EPA fully approves the plan before promulgating a FIP. CAA section 110(c)(1). In addition, as described above, States are required to submit a SIP revision to address a new or revised NAAQS within three years after promulgation of such standards that contains adequate provisions to prevent emissions from within the state from interfering with other states' measures to protect visibility. Idaho failed to submit a complete SIP revision within 3 years of promulgation of the revised 1997 Ozone and PM 2.5 NAAQS as required by section 110(a)(1) and meeting the requirements of section 110(a)(2)(D)(i). EPA is under a court order to take final action approving the Idaho Regional Haze SIP submittal, or to otherwise take action to meet the requirements of section 110(a)(2)(D)(i)(II) regarding visibility, by June 21, 2011. See 76 FR 1581, fn 5. In addition, IDEQ submitted the Regional Haze SIP revision to EPA on October 25, 2010, and included the Tier II operating permit for TASCO. EPA is obligated to take action on that submittal unless or until such time as the State of Idaho withdraws that submittal and submits a SIP revision.

TASCO's suggestion that the Tier II operating permit will change as a result of its challenge or the ongoing negotiations is speculative. If and when a revised permit is issued sometime in the future, Idaho may submit it for EPA review and action, as appropriate. Such SIP revision must meet Federal requirements and policy on SIP revisions, including the Regional Haze rule requirement that an alternative BART determination must achieve greater reasonable progress than would be achieved through installation and operation of BART. See 40 CFR 51.308(e)(2). TASCO's comments concerning the affordability analysis are addressed below.

Comment 1.b.: TACSO also requests that EPA postpone action on the SIP for a few additional reasons. First, it states that due to confusion and threatened litigation over EPA's national inaction on the Regional Haze Rule, Idaho may be the first, or one of the first, states to obtain approval. Thus, in their view, postponement of Idaho's plan would not deviate from a national level of inactivity. TASCO questions the urgency to partially approve Idaho's Regional Haze SIP and suggests that based on the emission inventories from other states, Idaho should be a low priority.

TASCO also requests an explanation for the decision to only partially approve the Regional Haze SIP and urges EPA to postpone final action on Idaho's plan until other components are ready for EPA action.

Finally, in TASCO's view, postponement of final action is consistent with an Executive Order dated January 18, 2011 which reaffirms regulatory review principles. TASCO contends the Regional Haze SIP is out of step with current economic and political realities. Specifically the comment states that the appropriate focus for visibility improvements under the CAA should be emission reductions from significant contributors, such as natural fire and mobile sources. EPA's proposed partial approval, specifically the TASCO BART determination, “ignores significant contributors and over regulates the minor contribution of the Riley Boiler. The proposal is not consistent with either the substance not the spirit of President Obama's EO.”

Response: There is no confusion regarding litigation over CAA section 110(a)(2)(D)(i)(II), the visibility prong of interstate transport, which is a separate legal action from litigation over EPA inaction on Regional Haze SIPs under Section 169(A)&(B). Idaho submitted the Regional Haze SIP to meet two provisions in the CAA—sections 110 and 169. As explained above, EPA must take action to meet the requirements of CAA section 110(a)(2)(D)(i)(II) regarding visibility by June 21, 2011. EPA's approval of the BART measures in the Idaho Regional Haze SIP submittal fulfills this obligation. EPA notes that the existence of any confusion regarding the timeline for EPA action on the Regional Haze SIPs is irrelevant to the question of whether the Regional Haze SIP submittal meets the requirements of the CAA or the regional haze program and has no impact on the statutory deadlines by which EPA must act. EPA intends to propose action on the remaining elements of the Idaho Regional Haze SIP submittal as expeditiously as possible, but finds no reason to delay action on the BART provisions.

Regarding TASCO's comment that this SIP action should be a low priority based on emission inventories from other states, EPA notes that BART obligations and the deadlines for taking action under the CAA apply regardless of the state-to-state relative emission inventories. Under the Regional Haze Rule, each state is required to address its contribution to visibility impairment in Class I areas. See e.g. 40 CFR 51.308(d)(3). In addition, while the Regional Haze Rule requires states to identify all anthropogenic sources of visibility impairment in developing its long-term strategy, Congress placed special emphasis on the use of retrofit controls for certain sources, such as the TASCO facility's Riley Boiler. IDEQ accordingly carefully considered the use of such controls at TASCO and determined that controls were cost-effective, would improve visibility, and were an appropriate measure for assuring reasonable progress toward the national goal.

The Executive Order identified by the commenter, EO 13563, provides that “[o]ur regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation * * *. It must identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends * * *” While EPA's compliance with EO 13563 is not subject to judicial review, EPA has complied with the EO in this action approving IDEQ's Regional Haze SIP submittal. First, we note that EPA's Regional Haze Rules provide substantial flexibility to the states in meeting the BART requirements in the CAA while still ensuring that reasonable progress towards the national goal is made. Second, TASCO's argument that EPA has ignored the contribution of other sources to visibility impairment in approving IDEQ's BART determination misrepresents EPA's role in evaluating a state's BART determination. The CAA provides no basis for EPA to disapprove a BART determination as overly stringent because a state has ignored other sources of impairment in its SIP.

Comment 2: On September 7, 2010, IDEQ issued a Tier II operating permit to TASCO that imposed both SO2 and NOx BART controls on the Riley Boiler at the TASCO Nampa facility and on October 12, 2010, TASCO filed a contested petition with the IDEQ challenging the reasonableness of the SO2 and NOx BART controls selected. In its comments to EPA, TASCO summarized the basis for its challenge at the state level to the Tier II operating permits.

Comment 2a: IDEQ failed to consider the 5-factors required by the CAA in choosing BART for SO2 and NOx emissions including the degree of improvement in visibility from the use such technology and the cost of compliance.

Response: The Riley Boiler at TASCO, Nampa, is a BART-eligible source subject-to-BART. Contrary to the commenter's claim, and as fully described in the Federal Register notice, IDEQ did consider the 5-factors in its BART determination for particulate matter, SO2 and NOx. See 76 FR 1586-1589. After determining the available control technologies, the five factors are: 1) Cost of compliance; 2) Energy and non-air environmental impacts; 3) any pollution control equipment in use at the source; 4) the remaining useful life of the facility; 5) the degree of improvement in visibility which may reasonably be anticipated to result from the use of such technology.

Comment 2b: IDEQ solely relied on conservative modeling results and excluded other relevant evidence resulting in an unreasonable BART selection for TASCO's Riley Boiler.

Response: While its not clear if TASCO is suggesting that EPA should disapprove IDEQ's BART detemination on these grounds, we disagree that IDEQ relied solely on conservative modeling results. Air quality dispersion modeling was used by Idaho for two purposes: to identify sources subject to BART and to estimate visibility improvement resulting from implementation of technically feasible BART control options. In the context of this comment, TASCO does not appear to contest IDEQ's identification of sources subject to BART, but rather the projection of improvement in visibility from implementation of BART.

To provide a consistent determination of baseline to future conditions of source specific visibility impacts, Idaho correctly used dispersion modeling. See 76 FR 1585 and EPA's evaluation of WRAP modeling in EPA's WRAP TSD, Section 6.A. The model Idaho used is consistent with BART Guidelines Appendix Y, (III)(3) which recommends use of modeling for individual source attribution with the CALPUFF model. See Appendix F, BART Modeling Protocol of the SIP submittal, (p. 30) for the application of the CALPUFF model.

EPA approved the BART-subject Modeling Protocol that was used by Idaho, Oregon and Washington in their determinations of which BART eligible sources are subject to BART. EPA's evaluation of BART modeling can be found in the WRAP TSD, Section 7 (p. 51) and Appendix F of the Idaho Regional Haze SIP submittal, (p. F-30).

Comment 2c: Evidence overlooked by IDEQ to support a more reasonable outcome for TASCO BART: The Riley Boiler is located over 100 miles and in the opposite prevailing west to east wind direction from Hells Canyon, Eagle Cap, and Strawberry Mountain Wilderness Areas.

Response: Prevailing winds and distance do not necessarily determine the maximum visibility impact of a specific source. Many meteorological factors need to be considered in determining visibility impact, thus the use of dispersion modeling for determining impact. See 40 CFR 51, Appendix Y (BART Guidelines, Section III and Section IV.D, 5.

Dispersion modeling demonstrates maximum impact of TASCO Nampa emissions are in the Eagle Cap Wilderness Area. Commenter has not provided any additional information or evidence to refute that determination.

Comment 2d: The Riley Boiler is a small industrial boiler not subject to the mandatory approach of Appendix Y BART Guidelines.

Response: The commenter is correct that IDEQ was not required to follow the EPA BART Guidelines at 40 CFR part 51, Appendix Y in making its BART determination. However, as explained in the BART Guidelines, the Guidelines establish an approach to implementing the BART requirements in the Regional Haze Rule, and that EPA believes the procedures in the guidelines should be useful to the States in all BART determinations.

Comment 2e: The Riley Boiler is the only sugar beet processing factory subject to BART.

Response: Whether or not the Riley Boiler is the only U.S. sugar beet processing factory subject-to-BART is not relevant to the question of whether IDEQ reasonably concluded that the boiler met the definition of a BART-eligible source and that the boiler could reasonably be anticipated to cause or contribute to any visibility impairment at a Class I area. Fossil-fuel boilers of more than 250 MBtu/hr heat input are potentially subject to BART, regardless of the type of industrial facility at which they are located. As explained in the notice of proposed rulemaking, IDEQ followed the BART evaluation process to identify the BART-eligible sources within the state boundaries, and determined, based on its modeled impacts, that TASCO could be reasonably anticipated to contribute to visibility impairment at the Eagle Cap Wilderness Area. 76 FR 1586.

Comment 2f: TASCO states that the overall contribution of Idaho stationary sources to visibility impairment from SO2 and NOx is small. Most impairment in Idaho Class I areas originates from outside the State. The commenter also notes that the Riley Boiler accounts for only a very small fraction of SO2 and NOx emissions in Idaho.

Response: By definition, regional haze means visibility impairment that is caused by the emissions of air pollutants from numerous sources located over a wide geographic area. 40 CFR 51.301. As a result, to make reasonable progress towards the national goal, states may be required to control emissions from sources that account individually for only a small fraction of the total emissions contributing to visibility impairment. As required by the CAA and EPA's regulations, the state must undertake a BART determination for certain sources such as TASCO that are reasonably anticipated to cause or contribute to any visibility impairment. The percent contribution of a specific BART eligible source to total Statewide or region-wide emissions is not a factor in determining whether that source can be considered to contribute to visibility impairment. See 40 CFR 51.308(e). To assess whether the impact of a single source is sufficient to cause or contribute to visibility impairment at any Class I area, Idaho selected a contribution threshold of 0.5dv, the upper bound for such a threshold. See 70 FR 39104, 39161 (July 6, 2005). Given this, IDEQ determined that TASCO Nampa exceeded the 0.5dv threshold and therefore correctly determined that the facility is subject-to-BART. The Riley Boiler's relative percent contribution of SO2 and NOx emissions in Idaho is not a factor in determining whether it is exempt from meeting the BART obligations of 40 CFR 51.308(e).

Comment 2g: By relying on conservative modeling results, IDEQ failed to adjust its conclusions in light of TASCO's source apportionment modeling that suggests the IDEQ modeling greatly overestimates visibility impacts of the Riley boiler.

Response: TASCO did not provide the TASCO source apportionment modeling results referred to in its comments. Thus, EPA cannot evaluate the credibility of the TASCO modeling, nor the significance of results.

However, in EPA's view, Idaho appropriately used CALPUFF modeling, as recommended by the BART Guidelines (Appendix Y of the Regional Haze Rule) to determine visibility impacts from TASCO. The modeling was conducted in accord with the BART Modeling Protocol, “Modeling Protocol for Washington, Oregon, and Idaho: Protocol for the Application of the CALPUFF Modeling System Pursuant to the Best Available Retrofit Technology (BART) Regulation.” This protocol was developed by Region 10 states and EPA Region 10 to provide consistency in decision making across Idaho, Oregon, and Washington in assessing the absolute and relative contribution of sources of visibility impairment. By providing for consistent estimates, the use of CALPUFF and specific modeling protocols ensures that sources are assessed equitably across a region. See 76 FR 1586. See also response to comment 2.b. above.

Comment 2.h: IDEQ failed to consider the shutdown of three coal-fired pulp dryers at the Nampa facility in 2007.

Response: Contrary to the comment, IDEQ did consider TASCO's shutdown and replacement of three coal-fired pulp dryers in the Regional Haze SIP submittal. However, the shut-down of other units at a facility is not a consideration to be taken into account in a BART determination. The BART determination for the Riley Boiler must be made independent of other control activities at the TASCO Nampa facility or other TASCO facilities located in Idaho.

Idaho did account for the shutdown of the pulp dryers in their assessment of baseline conditions at the Eagle Cap Wilderness Area. Idaho used the CALPUFF model results and applied scenarios with both the pulp dryers operating and not operating. See Table 10-11 of the SIP Submittal which provides the visibility impact of three scenarios: baseline with pulp dryers operating, baseline with pulp dryers shutdown, and BART implementation for NO X and SO 2 on the Riley Boiler.

Shutdown of the pulp dryers resulted in a reduction in days over 0.5 dv over a three year period from 127 days to 97 days. Implementation of NO X and SO 2 BART reduced the number of days over 0.5 dv to 3 days. Implementation of BART results in a significantly greater improvement in visibility than just the shutdown of the pulp dryers.

Comment 2.i: IDEQ failed to consider the additional emission reductions from TASCO's Nyssa, Oregon, shutdown in 2005.

Response: TASCO Nyssa, Oregon facility is not located in Idaho and not subject to Idaho's jurisdiction. Oregon has recognized the emission reductions associated with the shutdown of the TASCO Nyssa facility in their Regional Haze SIP. See Oregon Regional Haze SIP, Chapter 10.

Comment 2.j. The comment states that the costs of compliance are significant and could adversely affect operations at the Nampa facility. Installation of BART will require $15 million capital and annual operating expenses of over $644,000.

Response: In the TASCO BART analysis in the SIP submittal, Appendix F, the capital cost and annual costs for SO 2 and NO X level BART control were presented as follows from Table 31 and Table 35 of Appendix F and TASCO BART Determination, Appendix D:

Idaho determined the cost effectiveness of all technically feasible BART control options for SO 2 and NO X based on these capital investment and annual operating expenses. See Table 31 and Table 35 of Appendix F, TASCO BART determination, of the SIP submittal. The final BART determination of Low NO X Burners with Over Fire Air (LNB/OFA) for NO X at a cost of $1270/ton is reasonable when compared to other BART determinations across the country. The final BART determination of Dry Flue Gas De-sulfurization (Dry FGD) for SO 2 with a cost of $2163/ton is also reasonable.

The cost estimates in the SIP submittal differ (are higher) from the cost estimates provided in TASCO's comment letter. As explained in more detail below, while not required to do so, at IDEQ's request, EPA conducted an evaluation of whether TASCO could afford the BART controls and determined that it could afford the controls and remain a viable entity. EPA's evaluation of whether TASCO could afford the BART level control technology was based on the higher cost numbers in the SIP submittal. The lower costs in the TASCO comment letter would suggest TASCO could more readily afford the BART controls.

Comment 2.k. The degree of visibility improvement anticipated from BART is not measurable and does not justify the significant cost.

Response: We disagree that the visibility improvement anticipated from the use of BART at TASCO is not measurable. As explained in response to Comment 2.g. above, Idaho used the recommended dispersion model, CALPUFF, with a modeling protocol that was developed by EPA, Region 10 and the States of Idaho, Oregon and Washington to determine the improvements in visibility from the installation and operation of BART control technology. That model demonstrates significant improvement in visibility in the Eagle Cap Wilderness Area and other Class I areas as a result of BART controls on the TASCO Nampa facility. Implementation of Dry FGD for SO 2 control will reduce the number of days with impairment greater than 0.5 dv in the Eagle Cap Wilderness Area from 97 to 51 days over a 3 year period (with the pulp dryers shutdown). Implementation of LNB/OFA for NO X control will reduce the number of days with impairment in the Eagle Cap Wilderness Area from 97 to 56 days over a 3 year period (with the pulp dryers shutdown). See Table 32 and Table 37, Appendix F of the Idaho Regional Haze SIP submittal and 76 FR 1585. Combined SO 2 and NO X BART control will reduce the number of days over a 0.5 dv from 97 to 3 days over a 3 year period (with the pulp dryers shutdown). See Table 38 of Appendix F for the Idaho Regional Haze SIP submittal. As explained in response to Comment 2.j. above regarding costs of compliance, the cost associated with installation and operation of BART at TASCO Nampa, are not excessive and are comparable to the costs for other BART determinations across the country.

Comment 3: TASCO comments that IDEQ's approach to the BART determination for the Monsanto/P4 facility confirms the flexibility, discretion and streamlining that states are afforded in the BART process. The comment points out that the BART-subject kiln at the Monsanto/P4 facility is a significantly larger emission source than TASCO's Riley Boiler and has greater visibility impacts, but that IDEQ determined and EPA proposed to approve a BART determination for Monsanto/P4 that is less rigorous and costly than TASCO's. The comment further states that the BART determination that EPA proposed to approve for Monsanto/P4 allows a significant increase in potentially visibility impairing NO X emissions while EPA also proposed to approve a BART determination for TASCO that reduces emissions overall. The comment also contrasted the visibility improvement days predicted to result from the BART controls at TASCO Nampa facility versus the less number of visibility improvement days predicted to result from the required emission controls at Monsanto/P4 facility.

Response: EPA does not view TASCO's comment as supporting more stringent regulation of Monsanto/P4, but rather as presenting an argument that it should not be required to install BART controls that achieve tighter limits or greater improvements in visibility than other BART facilities in Idaho. EPA disagrees that IDEQ should impose BART controls at TASCO based on the results of its BART determination at another facility. A BART determination is made on a case-by-case basis, which by definition is based on facility-specific considerations.

EPA disagrees that IDEQ provided flexibility to Monsanto/P4 in the BART determination for the Rotary Kiln that was not provided TASCO. Due to the nature of the process at Monsanto/P4 ( i.e. limited temperature range) and existing control technology for SO 2 and PM, no technically feasible control technology is available. Thus, BART for the Rotary Kiln is `no additional control' and no emission limitations were established in the Idaho issued operating permit. In contrast, the TASCO Riley Boiler is a traditional coal-fired industrial boiler and technically feasible control options exist and are cost-effective.

EPA does not understand TASCO's comment that there would be the potential for a 2198 t/yr increase in NO X emissions from the Rotary Kiln based on the Monsanto/P4 BART determination. Since no additional control was determined to be BART, there is no potential to increase emissions since the existing emission limitations and design parameters at the facility will limit the production of sintered phosphate ore and limit NO X emissions to these production levels.

4. Comment: TASCO stated that EPA's review of the costs of compliance and affordability of BART controls for the Riley Boiler was flawed:

Comment 4.a. TASCO comments that “EPA concluded that since the company could fund the significant expense, the selected BART controls were affordable and indicates that because the EPA focused on the company's “financial status and health,” as well as whether the company could afford the controls and “remain viable”, EPA applied an inappropriate and arbitrary standard of review under EPA's BART regulations and guidance. TASCO also states that “EPA observed in its analysis, for example, that TASCO failed to be proactive and set aside funding for BART. EPA commented that TASCO should have been aware that “a decision not to proactively address BART costs prior to the issuance of a permit could make funding the BART related costs difficult.” TASCO also commented that EPA placed `substantial weight' on the statements of TASCO's auditors that EPA's interpretation misconstrued the Auditor's report and “EPA conveniently relied upon the auditor's silence regarding the BART issues to support their flawed conclusion.”

Response: The EPA BART guidelines, specifically allow, but do not require, affordability to be considered when determining BART. 70 FR 3917. The BART Guidelines indicate that there may be unusual circumstances that justify consideration of the plant and economic effects of requiring the use of a given control technology. The Guidelines suggest that economic effects include the effect on product prices, market shares and profitability of the source and that where there are special circumstances that are determined to affect plant operations, conditions of the plant and economic impacts of requiring controls may be considered. Id. The guidelines do not require that a specific method be used to conduct an affordability analysis nor do they specify a specific standard of review.

Thus, when making a BART determination the State may take into account the economic effects of requiring a particular control technology and may consider any resulting economic effects that are determined to have a severe impact on the plant's or company's operations. In this case, TASCO indicated to IDEQ that affordability was a critical element in the BART determination and IDEQ subsequently requested EPA to conduct an affordability analysis.

After considering a variety of factors, EPA determined that TASCO could afford to fund the BART controls and explained its reasoning in a separate report that was provided to IDEQ. See Executive Summary (Exec. Sum.) of the Affordability Analysis of the Amalgamated Sugar Company LLC's Affordability Claim with Respect to the Best Available Retrofit Technology (BART) for the Riley Boiler at the NAMPA, Idaho facility, February 12, 2010. (Affordability Analysis) (The Executive Summary, included in Docket for this rulemaking, is available to the public but the Affordability Analysis itself contains information claimed as Confidential Business Information and is not available for public review.) 3

Regarding TASCO's concerns about EPA's statement that TASCO should have been aware that “a decision not to proactively address BART costs prior to the issuance of a permit could make funding the BART related costs difficult”, TASCO appears to have taken EPA's statements out of context. The discussion in EPA's Affordability Analysis about how TASCO appears to have handled its finances as it relates to any prospective funding of BART was historical in context. EPA is aware that TASCO had no financial or legal obligation to fund the BART costs prior to issuance of a permit and/or SIP by IDEQ, or a FIP by EPA, as indicated in the Executive Summary (See Affordability Analysis, p.2). Since this issue was historical in context, it provided background for, but did not form a basis to determining whether TASCO could afford paying for BART.

TASCO is correct in stating “EPA placed `substantial weight' on the statements of TASCO's auditors.” (Affordability Analysis, pp. 37-38). As explained in the Affordability Analysis, EPA recognized that the auditor should have considerable knowledge of TASCO's operations; TASCO, Snake River Sugar Company (SRSC) and grower's relationships; external conditions that could impact TASCO; BART cost estimates and TASCO's ability to continue as a going concern, and felt that the auditor would be well informed about the companies' financial condition. Affordability Analysis pp. 32-28. However, as is evident throughout the Affordability Analysis, the auditor's statements are but one piece of the information EPA considered in its affordability analysis. See Affordability Analysis Exec. Sum. P.2; and Part II.

Furthermore, a reading of Part 2, Section F in the Affordability Analysis in its entirety demonstrates that EPA did not rely on the auditor's silence regarding the specific BART costs to support the conclusion that TASCO could afford the BART controls, but rather identified specific audit related issues that in the first instance could be relevant in determining whether TASCO could, or could not afford the BART related costs. These audit related issues included: the entity continuing as a going concern; subsequent events as they relate to an audit; and the type of opinion (and its contents) expressed by the auditor. (Affordability Analysis, pp. 35-37) The Affordability Analysis demonstrates that EPA was cognizant of the possible implications regarding whether certain issues were, or were not explicitly addressed by the auditor in the company's audited financial statements. As the Affordability Analysis explains, “In addition, even where the audited financial statements and auditor's report do not provide explicit confirmation of the entity's claims, understanding why these issues are absent from the auditor's report and financial statements can also provide important insight with respect to analyzing the entity's claims.” (Affordability Analysis p.32)

Comment 4.b. TASCO comments that EPA ignored information from TASCO. More specifically, TASCO states “The effects that this expenditure would have on `profitability', `market share', `plant operations' and position relative to `competing plants' are clearly fundamental to the evaluation. EPA ignored information from TASCO on the unusual circumstances within the sugar beet industry and the effects on the Nampa plant operations and costs, including its ability to compete in the U.S. sugar market.” TASCO further states that to the extent TASCO's circumstances were considered, EPA's analysis considered the overall economics of TASCO, the company and its related entities, not the conditions at the Nampa facility or the economic effects of requiring controls there. The direct effects on TASCO's Nampa plant operations were underestimated or ignored by EPA. TASCO also comments that EPA dismissed the localized effects on the specific plant operations at Nampa and instead focused on an assessment of the TASCO business structure.

In commenter's view, EPA's notion of spreading cost throughout the Idaho sugar beet farmers is flawed and defies the realities of the sugar beet industry and TASCO's operations and underestimates the extent of the adverse impacts [of the BART determination]. TASCO states that reduced payments to growers in order to fund BART controls at Nampa will result in decreased acreage planted in sugar beets throughout Idaho. EPA unrealistically assumed that growers will continue to plant sugar beets, and ignored the declining trend in acreage planted in sugar beets.”

Referring to EPA's affordability analysis, TASCO commented that EPA failed to consider whether competing plants in the same industry are required to install BART controls and asserts that they know of no other plant in the sugar industry in the US that is required to install BART control and ignores information from TASCO about the uniqueness of imposing BART on a small industrial boiler relative to competing plants in the sugar beet industry.

Finally, TASCO described the closure of TASCO's Nyssa factory “as evidence of the vulnerability and actual impact of plant operations from diminished sugar beet acreage. TASCO also highlighted the 31% decline in sugar beet harvest between 2007 and 2008 and EPA downplayed these plant specific impacts, and emphasized other information to conclude that TASCO, the company, is economically stable.”

Response: In determining whether TASCO could afford the BART level controls, EPA considered a variety of information, including but not limited to information provided by TASCO. As explained in the Executive Summary, the analysis considered a number of factors including the estimated capital and operation and maintenance costs, the estimated BART compliance date, TASCO's ability to continue as a viable company, the business/financial relationship between TASCO and the Snake River Sugar Company (SRSC) and other factors. The analysis specifically included information provided by TASCO. (Exec. Sum. p. 2)

EPA encouraged TASCO to provide any additional substantive information to substantiate its claims regarding affordability. However, TASCO never provided specific documentation or information that substantively demonstrated how the BART costs would adversely impact the Nampa facility specifically or that substantively supported their affordability claim. For example, the company failed to provide information regarding the minimum annual input of sugar beets needed for each facility or how BART related costs would specifically impact the number of growers. The Analysis explained that “based on the available information, it appeared that TASCO's conclusion that less growers necessarily equals less revenue is not supported.” Affordability Analysis p. 25-26. The comments also failed to provide substantiated information regarding these items. Additionally, as mentioned in the Affordability Analysis, when making its initial affordability claim TASCO stated that “[a] very large consideration of this [BART determination] analysis is the ongoing viability of the Nampa facility and TASCO as a whole.” (Affordability Analysis p. 15) Thus, TASCO itself recognized the economic status of the company as a whole was relevant.

TASCO's comment also expressed concern with EPA's observation that TASCO could spread the cost of controls among sugar beet growers throughout Idaho. The comment stated that EPA unrealistically assumed that growers will continue to plant sugar beets, and ignored the declining trend in acreage planted in sugar beets. However the comment fails to substantiate its claims that reduced payments to growers would necessarily result in decreased acreage planted in sugar beets in Idaho or to refute EPA's assumptions. The Affordability Analysis indicated EPA's perspective on this issue and explained that a sugar beet grower faces a number of choices in deciding whether or not to grow sugar beets. EPA considered how charging the capital cost for BART controls to the growers could affect their decision to continue growing sugar beets. But, as explained, EPA cannot make any determination as to whether any capital cost charged to a grower will determine whether that grower decides not to grow sugar beets ( e.g., move from sugar beets to an alternative crop). EPA also refers to the Patterson study (2009) which compared sugar beets, at different price and yield levels, to alternative crops. Affordability Analysis, p. 27. Furthermore, the analysis also recognized that an additional factor a grower must take into consideration in deciding not to grow sugar beets is that “member grower who decides not to grow, i.e., to withdraw from the Cooperative (SRSC), would face a significant monetary charge from SRSC.” Id. Another implication is that the grower has crop alternatives though these other crops may not provide a long-term solution. Id. As part of its review EPA explained that “An analysis of the economics of growing sugar beets in southern Idaho, released in January 2009, provides important insight into recent sugar beet prices paid to growers:

Regarding TASCO's comment about the closure of the TASCO Nyssa, Oregon plant, in conducting the Affordability Analysis EPA considered and weighed all information it had available in coming to its conclusion. If it appears that EPA downplayed certain impacts, it is because there was additional substantive information as summarized above and described throughout its analysis that provided the basis for EPA's affordability conclusion, and TASCO did not provide substantive information to support its assertions. For example, with respect to TASCO's comment regarding the closing of the Nyssa factory: TASCO stated that “the economic benefit to the grower-owned Cooperative of running three factories compared to four is significant and cannot be ignored.” (Affordability Analysis p. 27.) TASCO did not provide plant specific substantive information that would enable EPA to validate TASCO's stated concerns about BART impacts to the Nampa factory and the other two factories, and to the growers, e.g., plant capacities, plant operating margins, etc.

Comment 4.c.: TASCO commented that the estimated cost of compliance will exceed $75,000 per grower that supplies sugar beets to the Nampa factory, based upon an estimated capital cost of $15,690,000. TASCO stated that this amount exceeds the estimated annual profit per grower which is conservatively $65,400.

Response: There are several parts to TASCO's comment. First, TASCO indicates that the $75,000 BART related cost per grower is charged to the Nampa growers as a one-time charge. However, when as part of its analysis EPA calculated BART capital costs to the growers (Nampa only growers, and to all growers), EPA amortized these costs over two different time periods based on information provided by TASCO. See Affordability Analysis p. 26; Table 6, p. 29; p. 36. Second, TASCO's most recent capital cost estimate ($15,690,000) is $2.11 million less than the capital cost EPA used for the Affordability Analysis ($17.8 million) which was based on TASCO's BART Analysis. See Regional Haze SIP submission, Appendix F, Table 31 and Table 35. Furthermore, the number of growers for the Nampa factory and in total—(see TASCO comments, footnote 8) are greater than those used in the Affordability Analysis. See TASCO comment footnote 8 compared to Affordability Analysis Table 6, p. 29. Mathematically this would indicate that any new calculations made using this latest information would mean lower BART related charges passed on to each grower. Third, as explained in EPA's analysis, allocating the BART capital costs only to the Nampa factory growers and not to all the growers is a business decision made by TASCO. Affordability Analysis p. 26. Using the TASCO figures provided in the comment, calculated for the two amortization periods of six years or nine years, the amortized BART capital cost to all growers would amount to less than $0.45 per ton of sugar beets or less than $0.30 per ton of sugar beets, respectively, and if the cost was the allocated only to the Nampa growers it would be approximately $1.75 and $1.17 respectively—amounts less than the figures indicated in EPA's original analysis. See Affordability Analysis Table 6.

Comment 4.d: EPA failed to consider whether competing plants in the same industry are required to install BART controls and asserts that they know of no other plant in the sugar industry that is required to install BART controls and ignores information from TASCO about the uniqueness of imposing BART on a small industrial boiler relative to competing plants in the sugar beet industry.

Response: The BART Guidelines provide that an affordability analysis may consider whether other competing plants in the same industry have been required to install BART controls. 70 FR 39171. However, in this instance EPA's analysis determined that regardless of the number of other facilities in this industry subject to BART, the cost for TASCO to implement the controls determined to be BART are affordable and would not significantly impact its continued economic viability. Additionally, as explained above, TASCO did not provide or substantiate its claims to demonstrate that it would operate at a competitive disadvantage and thus, EPA was not able to determine the relative competiveness between TASCO and other sugar beet processors.

Comment 5: TASCO's comment letter to EPA included statements regarding the additional information it has outlined for IDEQ in the negotiations with the State to resolve the Tier II operating permit challenge.

Response: This comment relates to the pending negotiations between TASCO and the State. At this point in time EPA does not know how IDEQ will evaluate or use the additional information provided to it. If the State revises the TASCO operating permit and submits it to EPA, at that time EPA will evaluate IDEQ's decision and the information upon which it is based.

Comment 1: The commenter requests that a BART determination be conducted and BART emission limitations be imposed for two additional sources in Idaho: Nu West/Agrium facility (Nu West) in Soda Springs and the J.R. Simplot Don Plant (J.R. Simplot) in Pocatello. The commenter asserts that given that the Nu West and J.R. Simplot plants are directly upwind and in close proximity to Wyoming Class I areas, it seems clear they should merit special attention through a requirement for the installation of BART. The data developed by the State of Wyoming for its draft Regional Haze SIP also make it clear that Idaho sources of air pollution are one of the most significant contributors to visibility impairing haze in Wyoming Class I areas. The commenter also suggests the 0.5 dv impact threshold used to determine whether a BART eligible source is subject to BART, was determined for only Class I areas located in Idaho. The comment then suggests concern that all seven Wyoming Class I areas, and especially the Bridger and Fitzpatrick Wilderness Areas, are directly downwind of these plants (Nu West and J.R. Simplot), and in quite close proximity to them. Thus, absent empirical data to the contrary, there should be no finding that the J.R. Simplot and Nu West plants are not significantly impacting Wyoming Class I areas.

Response: In determining which BART eligible sources would be subject to BART, Idaho considered all Class I areas within a 300 km radius of the source, including Class I areas outside the State boundary. Air quality dispersion modeling is the preferred technique to determine a single source's impact on any Class I area. See BART Guidelines, Section I.A. As discussed above, the modeling completed by Idaho demonstrates that BART-eligible sources located in Idaho, other than those identified in the SIP submittal as exceeding the BART contribution threshold, do not significantly impact Class I areas within a 300 km radius of the source, including Class I areas in Wyoming and Montana. Furthermore, IDEQ consulted with Wyoming (Wyoming Department of Environmental Quality) and other neighboring states regarding its emission reduction contribution. This consultation included the review of major contributing sources of air pollution, interstate transport of emissions, major emission sources believed to be contributing to visibility impairment, and whether any mitigation measures were needed. See Chapter 13.2.1 of the Idaho Regional Haze SIP submittal.

As explained in the Idaho Regional Haze SIP submission, Idaho considered whether these two BART eligible sources were subject-to-BART. See Regional Haze SIP submittal Appendix F, Table 3 for a discussion of the Nu West modeling to determine whether it met the threshold for being subject to BART. The modeling shows the impact of Nu West in Class I areas within a 300 km radius, including the Bridger and Fitzpatrick Wilderness Areas. The SIP submittal explains that over a three year period (2003-2005) there were no days where Nu West had an impact of greater than 0.5 dv, the Idaho threshold for sources being subject to BART. The greatest impact occurred in the Bridger Wilderness Area with a value of 0.051 dv, or approximately 1/10 the level of the `BART subject' threshold.

A discussion of the J.R. Simplot modeling to determine whether it met the threshold for being subject to BART can be found in the SIP submittal, Appendix F, Table 11 (page 198 of Appendix F of the SIP submittal). The modeling shows the impact of J.R. Simplot in Class I areas within a 300 km radius of the plant, including the Fitzpatrick Wilderness Area. Over a three year period (2003-2005) there were no days where J.R. Simplot had an impact of greater than 0.5 dv in the Fitzpatrick Wilderness Area.

The modeling showed that neither facility met the 0.5 dv contribution threshold. Therefore, IDEQ reasonably determined that neither Nu West nor J.R. Simplot were subject to BART. As explained in the proposed rulemaking EPA agreed with the State's determination in this regard.

Comment 2: The commenter believes that Region 10 should make good on its finding that the 0.5 dv threshold is not adequate to avoid the requirement for BART to be installed because there is likely no objective basis to claim that the J.R. Simplot and Nu West plants have “relatively limited impact on visibility” when it comes to Wyoming Class areas. If the greatest improvements due to BART being required on the Monsanto/P4 Plant are seen at the Teton Wilderness Area, it seems very likely that even greater benefits would be seen at the Bridger and Fitzpatrick Wilderness Areas if BART were required for the J.R. Simplot and Nu West plants. Consequently BART should be required for these sources of emissions.

Response: As explained above, the methods and process IDEQ used to determine that 0.5dv is an appropriate threshold to use to determine if an individual source is subject to BART are consistent with the Regional Haze Rule. For the reasons explained in the Federal Register notice describing the rationale for the proposed action, while Idaho failed to provide an adequate rationale for selecting the 0.5 dv threshold for determining BART eligible sources subject to BART, EPA determined that even with a more robust rationale the 0.5 dv threshold was acceptable. 76 FR 1585. Additionally, in reviewing the modeling results for Nu West and J.R. Simplot for determining whether they are subject to BART, it is apparent that Idaho would had to have established a threshold below 0.1 dv in order to include these additional sources subject to BART. A 1.0 dv change in visibility is usually a small but perceptible scenic change. (See Interagency Monitoring of Protected Visual Environments (IMPROVE) newsletter, Vol. 2 No. 1, Winter 1993). In EPA's view, generally a 0.1 dv threshold is unreasonable because the human eye could not perceive this change in visibility impairment and yet would require significant expenditure of resources to implement BART.

The Wyoming Regional Haze SIP submittal that was submitted to EPA Region 8 does not identify any sources in Idaho that significantly impact Class I areas in Wyoming. In developing the Reasonable Progress Goals for Class I areas in Wyoming, the Wyoming SIP relies on the consultation process in the WRAP for establishing emission reductions from sources located in Idaho. See Chapter 11.1 page 184 of the Wyoming SIP submittal.

EPA is approving the BART measures in the Idaho Regional Haze plan as meeting the requirements of section 110(a)(2)(D)(i)(II) of the CAA with respect to the 1997 8-hour ozone and 1997 PM 2.5 NAAQS. In addition, EPA is approving portions of the Idaho Regional Haze SIP, submitted on October 25, 2010, as meeting the requirements set forth in section 169A of the Act and in 40 CFR 51.308(e) regarding BART. EPA is also approving the Idaho submittal as meeting the requirements of 51.308(d)(2) and (4)(v) regarding the calculation of baseline and natural conditions for Craters of the Moon National Monument, Sawtooth Wilderness Area, and Selway-Bitterroot Wilderness Area, and the statewide inventory of emissions of pollutants that are reasonably anticipated to cause or contribute to visibility impairment in any mandatory Class I Federal Area.

Idaho has not demonstrated authority to implement and enforce IDAPA chapter 58 within “Indian Country” as defined in 18 U.S.C. 1151. 4 Therefore, EPA proposes that this SIP approval not extend to “Indian Country” in Idaho. See CAA sections 110(a)(2)(A) (SIP shall include enforceable emission limits), 110(a)(2)(E)(i) (State must have adequate authority under State law to carry out SIP), and 172(c)(6) (nonattainment SIPs shall include enforceable emission limits). This is consistent with EPA's previous approval of Idaho's prevention of significant deterioration (PSD) program, in which EPA specifically disapproved the program for sources within Indian Reservations in Idaho because the State had not shown it had authority to regulate such sources. See 40 CFR 52.683(b). It is also consistent with EPA's approval of Idaho's title V air operating permits program. See 61 FR 64622, 64623 (December 6, 1996) (interim approval does not extend to Indian Country); 66 FR 50574, 50575 (October 4, 2001) (full approval does not extend to Indian Country).

Acronyms and Abbreviations. The following acronyms and abbreviations are used in this document.

EPA published Subpart I: Electronics Manufacturing of the Greenhouse Gas Reporting Rule on December 1, 2010 (75 FR 74774). This subpart requires monitoring and reporting of greenhouse gas (GHG) emissions from electronics manufacturing. Included in the December 1, 2010 final rule are provisions allowing owners or operators of semiconductor manufacturing facilities the option of using and/or requesting the use of best available monitoring methods (BAMM) for specified parameters. Specifically, from January 1, 2011 to June 30, 2011, owners or operators may use BAMM for any parameter that cannot reasonably be measured according to the monitoring and QA/QC requirements of Subpart I without submitting a request to and receiving approval from the Administrator (40 CFR 98.94(a)(1)). To extend the use of BAMM to estimate emissions that occur beyond June 30, 2011, the December 1, 2010 final rule provides that owners and operators must submit a request to and receive approval from the Administrator consistent with the following:

• Requests for extension of the use of BAMM to estimate emissions that occur from July 1, 2011 through December 31, 2011 for parameters other than recipe-specific utilization and by-product formation rates for the plasma etching process type must have been submitted to EPA no later than February 28, 2011 (40 CFR 98.94(a)(2)).

• Requests for extension of the use of BAMM to estimate emissions that occur from July 1, 2011 through December 31, 2011 for recipe-specific utilization and by-product formation rates for the plasma etching process type must be submitted to EPA no later than June 30, 2011 (40 CFR 98.94(a)(3)).

• Requests for extension of the use of BAMM to estimate emissions beyond December 31, 2011 for unique and extreme circumstances must be submitted to EPA no later than June 30, 2011 (40 CFR 98.94(a)(4)).

Following the publication of subpart I in the Federal Register , the Semiconductor Industry Association (SIA) sought reconsideration of several provisions in the final rule, including the provisions relating to BAMM. In its Petition for Reconsideration dated January 31, 2011 (available in docket EPA-HQ-OAR-2009-0927), SIA stated that the BAMM provisions raise “substantive compliance issues.” In particular, SIA stated that the substantive compliance issues relate to the following aspects of the BAMM provisions: The requirement to recalculate and resubmit estimated emissions, the individual requirement-by-requirement BAMM request process, the documentation requirement, the timeframe for assembling the documentation, and the unique and extreme circumstances provision. More specifically, SIA stated that the individual requirement-by-requirement BAMM request process is cumbersome and unreasonably burdensome, and that the required documentation to support the request is excessive. Further, SIA stated that the deadlines for submitting the request to use BAMM were “unreasonable.” In particular, SIA stated that the June 30, 2011 deadline for the recipe-specific utilization and by-product formation rates was “not realistic” due to “serious technical infeasibility issues.” SIA also noted that the individuals who would be responsible for analyzing Subpart I, gathering information, and preparing the BAMM requests were the same individuals who would be working with EPA “towards mutually acceptable solutions and alternatives.”

EPA has concluded that pursuant to CAA section 307(d)(7)(B) it is appropriate to extend by three months the period in 40 CFR 98.94(a)(1), during which owners and operators have the option to use BAMM in 2011 without submitting a request for approval from the Administrator. EPA has also concluded that pursuant to CAA section 307(d)(7)(B) it is appropriate to extend by three months the deadlines in 40 CFR 98.94(a)(3)(i) and 98.94(a)(4)(i), by which owners and operators may submit a request for approval by the Administrator to use BAMM in 2011 for recipe-specific utilization and by-product formation rates (recipe-specific emission factors) for the plasma etching process type, and to use BAMM to estimate emissions that occur beyond December 31, 2011 for unique and extreme circumstances, respectively. Extending the deadlines will allow EPA additional time to consider comments and take final action on a proposal that EPA is also publishing today, as discussed in more detail in the following paragraphs.

In a separate action also published in today's Federal Register (please refer to the proposed rule Mandatory Reporting of Greenhouse Gases: Changes to Provisions for Electronics Manufacturing (Subpart I) to Provide Flexibility in docket EPA-HQ-OAR-2009-0927), EPA is proposing to allow the largest semiconductor facilities the option of calculating emissions using default utilization and by-production formation rates (default emission factors) already contained in Subpart I for the plasma etching process type for a limited time period instead of calculating emissions using directly measured recipe-specific emission factors during that time period. 1 The December 1, 2010 final rule provides that the largest semiconductor manufacturing facilities are required to calculate emissions for the plasma etching process type using only directly measured recipe-specific emission factors. Other semiconductor manufacturing facilities that manufacture wafers on 300 millimeters (mm) or less in diameter are required to calculate emissions for the plasma etching process type using default emission factors provided in Tables I-3 and I-4 of Subpart I.

In the separate action also published in today's Federal Register, EPA is proposing to allow the largest semiconductor facilities to use the same default emission factors already used by the other semiconductor manufacturing facilities that manufacture wafers on 300 mm or less in diameter during the initial years of implementation of Subpart I in response to concerns raised by SIA in their Petition for Reconsideration regarding the individual recipe measurement approach, that is, the requirement that the largest facilities develop and use recipe-specific emission factors for etch processes. More specifically, in their Petition, SIA stated that the individual recipe measurement approach is technically impractical, burdensome, threatens intellectual property, and would hamper innovation. SIA also stated its member companies' “strong desire to reach agreement with EPA on an alternative” to that measurement approach. By extending the dates by which a facility may use and/or request the use of BAMM in today's final action, EPA will have additional time to consider comments and take final action on provisions in the separate action to allow the largest semiconductor manufacturing facilities to use the default emission factors already contained in Subpart I in the initial years of implementation. In turn, this will provide a clear, consistent approach to compliance with Subpart I while EPA considers longer-term alternatives.

In today's final rule, EPA is taking no action on other issues raised by SIA in their Petition for Reconsideration. EPA is also taking no action at this time on issues raised by 3M Company in their January 28, 2011 Petition for Reconsideration of Subpart I.

Pursuant to Clean Air Act (CAA) section 307(d)(7)(B), EPA is extending the deadlines in 40 CFR 98.94(a)(1), 40 CFR 98.94(a)(3)(i), and 40 CFR 98.94(a)(4)(i) for three months; i.e., until September 30, 2011.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment. We are acting pursuant to CAA section 307(d)(7)(B) to extend these deadlines in part because we are considering a change to Subpart I, which would obviate the need to conduct a BAMM process for this aspect of the rule. In addition, we are extending these provisions to allow owners and operators of affected facilities additional time to assess their facilities to determine if it will be necessary for them to apply for BAMM for any other aspect of Subpart I beyond 2011 for unique and extreme circumstances. Because we cannot predict the outcome of today's proposed rule, we have concluded that a limited extension pending final action on that proposal is appropriate so that owners and operators of affected facilities would not incur additional costs associated with applying for BAMM in advance of our final decision on this issue. It would be impracticable to go through notice and comment rulemaking to extend an imminent deadline, and it is also unnecessary because section 307(d)(7)(B) does not require notice and comment for a three-month extension pending reconsideration. Thus, notice and public procedure are impracticable and unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B) in this instance.

This action is not a “significant regulatory action,” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and, therefore, not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). In addition, because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute ( see Section I of this preamble) it is not subject to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). In addition, this action does not impose any enforceable duty or contain any unfunded mandates as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with State officials, as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or involve special consideration of environmental justice related issues, as required by Executive Order 12898 (59 FR 7629, February 16, 1994). Further, because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ). This action also does not have Tribal implications because it will not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ). EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in the December 1, 2010 Federal Register document.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This rule will be effective June 30, 2011.

This Federal Register notice is available in the docket for the final rule titled “ Mandatory Reporting of Greenhouse Gases: Additional Sources of Fluorinated GHGs, ” published on December 1, 2010 at 98 FR 74774, under Docket ID No. EPA-HQ-OAR-2009-0927.

All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information may not be publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA's Docket Center, Docket ID No. EPA-HQ-OAR-2009-0927, Public Reading Room, EPA West Building, Room 3334, 1301 Constitution Avenue, Northwest, Washington, DC 20460. This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Air Docket Center is (202) 566-1741.

In addition to being available in the docket, an electronic copy of this Federal Register notice is also available on the World Wide Web at http://www.epa.gov/climatechange/emissions/ghgrulemaking.html.

For the reasons discussed in the preamble, title 40, chapter I, of the Code of Federal Regulations is amended as follows:

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

• Crop production (NAICS 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 site at http://www.gpoaccess.gov/ecfr.

Under FFDCA section 408(g), 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. 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-2010-0330 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 22, 2011. 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-2010-0330, 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 June 8, 2010 (75 FR 32466) (FRL-8827-8), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 0E7693) by FB Sciences, Inc., 153 N. Main Street, Ste. 100, Collierville, TN 38017. The petition requested that 40 CFR 180.910 and 180.930 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-methyl-2,4-pentanediol (CAS Reg. No.107-41-5) when used as an inert ingredient as a solvent in pesticide formulations applied to crops pre-harvest and post-harvest and to animals without limitations. That notice referenced a summary of the petition prepared by FB Sciences, Inc., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 2-methyl-2,4-pentanediol including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with 2-methyl-2,4-pentanediol 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. Specific information on the studies received and the nature of the adverse effects caused by 2-methyl-2,4-pentanediol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

2- methyl-2,4-pentanediol (CAS Reg. No. 107-41-5) is an aliphatic alcohol also known as: Hexylene glycol; diolane; and 1,1,3-trimethyltrimethylene-diol. Non-pesticidal uses of 2-methyl-2,4-pentanediol include use as a chemical intermediate, a selective solvent in petroleum refining, a component of hydraulic fluids, a solvent for inks, as an additive to cement, textile dye vehicles, a lubricant and fuel additive, and as an ingredient in cosmetics and hair care products. The Food and Drug Administration (FDA) has approved of the use of 2-methyl-2,4-pentanediol as an indirect food additive such as in adhesives in contact with food under 21 CFR parts 175-178.

2-methyl-2,4-pentanediol is not acutely toxic to rats via the oral route of exposure. An Organization for Economic Cooperation and Development (OECD)-SIDS (2001) report indicates LD 50 ranges from 2-4.47 g/kg. Acute dermal toxicity is low with dermal doses up to 2,000 milligrams/kilogram (mg/kg) that did not cause death (as cited in OECD-SIDS, 2001). It is irritating to the skin and eyes, but not a skin sensitizer in guinea pigs. It has low inhalation toxicity, with an LC 50 of 160 parts per million (ppm) (0.772 mg/L), which is in excess of the saturated vapor concentration.

In a 90-day subchronic toxicity study, 2-methyl-2,4-pentanediol was administered by oral gavage to rats at dose levels of 50, 150, or 450 mg/kg/bw/day. In this study the functional observational battery, blood chemistry, hematological parameters and histopathological examinations were conducted. A functional observational battery test gave no indication of neurotoxicity. In both sexes, hyperplasia, hyperkeratosis, inflammatory cell infiltration and edema of the mucosa and submucosa of the stomach were observed starting at 150 mg/kg/day. These changes were indicative of a local irritative effect resulting from the oral gavage procedure. Hepatocellular hypertrophy with increased liver weight was observed at 450 mg/kg/day in both sexes, and in males at 150 mg/kg/day. In the absence of degenerative or necrotic changes these findings were considered to be adaptive responses. At 150 and 450 mg/kg/day, increased kidney weights and increased incidence of acidophilic globules in the tubular epithelium in males were suggestive of male rat specific alpha-2-microglobulin nephropathy, which is not considered as an effect relevant to humans. Observed changes were either fully or partially reversible over the 4-week recovery period. There were no adverse effects on the reproductive organs. No effects were observed at 50 mg/kg/day. A NOAEL of 450 mg/kg/day was determined for systemic toxicity because the effects described were either produced by irritation from the oral gavage procedure, or were considered adaptive responses. A range-finding 14-day study gave similar results.

No guideline reproduction studies were available for assessment, however, no adverse effects on reproductive organs (including testes, prostate, seminal vesicles, epididymis, ovaries, vagina, and uterus) were observed in the 90-day gavage study in which rats were administered 2-methyl-2,4-pentanediol at doses up to 450 mg/kg/day. Therefore, OECD SIDS concluded that no additional studies are required under the SIDS program regarding fertility. EPA agrees with this conclusion by the OECD.

In a developmental toxicity study, pregnant rats were administered 30, 300, or 1,000 mg/kg/bw/day of 2-methyl-2,4-pentanediol by gavage in 5 mL/kg of vehicle on gestation days (GD) 6-15. The NOAEL for maternal toxicity was 300 mg/kg/day based on a statistically significant reduction in group mean body weight gain and food consumption at 1,000 mg/kg/day. There was a marginal, non-statistically significant reduction in fetal body weight at 1,000 mg/kg/day. Marginally higher incidences of fetal variations, some of which were statistically significant (occipitals incompletely ossified, 21.6%; extra thoracolumbar ribs, 18.7%; and hyoid arch not ossified, 18%), occurred at 1,000 mg/kg/day. A delay in the normal ossification process was also observed in fetuses, but this was considered by the study authors to be related to reduced maternal body weight gain at this dose level. The NOAEL and LOAEL for maternal and fetal developmental toxicity were determined to be 300 and 1,000 mg/kg/day, respectively.

In another developmental toxicity study, pregnant rats received 500, 1,200, or 1,600 mg/kg/bw/day of 2-methyl-2,4-pentanediol by gavage in 10 mL/kg of vehicle on GD 6-17. At 1,200 and 1,600 mg/kg/day, dams had ataxia and reductions in mean weight gain and food consumption. At the 1,600 mg/kg/day, pregnant rats had mean weight loss, and one female aborted prior to the end of the study. Maternal toxicity at these levels corresponds to decreased fetal body weights and gravid uterine weights. Additionally, at 1,600 mg/kg/day, there was one abortion and one whole litter resorption. However, the number of fetal malformations, such as increased incidence of skeletal variations (delayed ossification, extra ribs), was not significantly different from controls. A maternal NOAEL of 500 mg/kg/day was determined by the Agency, and the same NOAEL was determined in the study for fetal toxicity. These results support the results of a study described in this unit and indicate that 2-methyl-2,4-pentanediol has low potential for developmental toxicity.

2-methyl-2,4-pentanediol is not genotoxic in either mammalian or non-mammalian cells “in vitro.” It was negative for mutagenicity in the Ames test, yeast cell assay and hamster ovary cell assay.

Ten rats and a rabbit exposed to an aerosol of 2-methyl-2,4-pentanediol at a concentration of 0.7 mg/L (about 145 ppm) for 7 hr/day for 9 days survived with mild upper respiratory irritation. No histopathological effects were reported.

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.

No acute endpoint of concern was identified in the available toxicity studies. The endpoint of concern for the chronic reference dose (cRfD) was identified from the developmental toxicity study in rats. In this study, the NOAEL (500 mg/kg/day) was based on increased incidence of clinical signs, reductions in mean body weight gain and food consumption seen at the LOAEL of 1,200 mg/kg/day and above. This NOAEL was supported by the 90-day gavage toxicity study in rats (NOAEL 450 mg/kg/day; highest dose tested). There was a lower NOAEL (300 mg/kg/day) observed in the range finding study in rats based on a statistically significant reduction in group mean body weight gain and food consumption, and marginally higher incidences of fetal variations seen at the LOAEL of 1,000 mg/kg/day. The differences between the NOAELs of the range finding study and the developmental toxicity study in rats were considered due to artifacts of dose selection. An uncertainty factor 100X (10X for intraspecies variability and 10X interspecies extrapolation) was applied to the NOAEL. No additional uncertainty factor is necessary for use of the subchronic to chronic study because the effects were observed at the limit dose of 1,000 mg/kg/day and above. The FQPA factor for increased susceptibility of infant and children was reduced to 1X. Therefore, the cRfD is equal to population adjusted dose (cPAD). This endpoint and the dose was also used for dermal and inhalation exposure assessment for all exposure scenarios. Inhalation and dermal absorption was assumed to be 100%. This approach would provide a highly conservative estimate of risk via the dermal and inhalation routes of exposure.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to 2-methyl-2,4-pentanediol, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from 2-methyl-2,4-pentanediol in food as follows:

No acute endpoint of concern was identified in the database. Therefore, a quantitative acute dietary exposure assessment was not conducted.

i . Chronic exposure. In conducting the chronic dietary exposure assessments, EPA used food consumption information from the United States Department of Agriculture (USDA) [1994-1996 and 1998] Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data were submitted for 2-methyl-2,4-pentanediol. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentration of active ingredient in agricultural products is generally at least 50% of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100% of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

ii. Cancer. Chronic and carcinogenicity studies were not available on 2-methyl-2,4-pentanediol. There is no evidence that 2-methyl-2,4-pentanediol is carcinogenic. The Agency used a qualitative structure activity relationship (SAR) database, DEREK Version 11, to determine if there were structural alerts. No structural alerts were identified. In addition, it is negative for mutagenicity in mammalian and non-mammalian mutagenicity assays. 2-methyl-2,4-pentanediol is rapidly metabolized and excreted as glucuronates. Based on weight-of-evidence and low toxicity mentioned in this unit, 2-methyl-2,4-pentanediol is not expected to be carcinogenic. Since the Agency has not identified any concerns for carcinogenicity relating to 2-methyl-2,4-pentanediol, a dietary exposure assessment to evaluate cancer risk was not performed.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for 2-methyl-2,4-pentanediol, a conservative drinking water concentration value of 100 ppb based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. 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). No residential uses as a pesticide inert ingredient have been requested and none are expected. Although 2-methyl-2,4-pentanediol is used in cosmetics and hair care products, the Agency believes exposure and risk from these routes of exposure to be negligible. The FDA includes 2-methyl-2,4-pentanediol ( i.e., hexylene glycol) in its list of Indirect Additives Used in Food Contact Subtances. The exposure to 2-methyl-2,4-pentanediol through hair color use is considered minimal because it is a volatile chemical, treatment times are very short and absorption through the scalp is limited. Based on these considerations, the Agency concluded that there is no need to conduct aggregate exposure through use of consumer products. Further, there are no reliable data with which to estimate such exposures.

4. 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 2-methyl-2,4-pentanediol to share a common mechanism of toxicity with any other substances, and 2-methyl-2,4-pentanediol does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-methyl-2,4-pentanediol 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 Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. 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 FQPA Safety Factor (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.

2. Prenatal and postnatal sensitivity. The maternal and developmental effects were only observed at the limit dose of 1,000 mg/kg/day and above in the developmental toxicity study in rats. Maternal and fetal toxicity were mainly manifested as decreases in body weights. Marginally higher incidences of fetal variations were also observed at the limit dose or above. There were no guideline reproduction studies available on 2-methyl-2,4-pentanediol; however, no adverse effects on reproductive organs (including testes, prostate, seminal vesicles, epididymis, ovaries, vagina, and uterus) were observed at doses up to 450 mg/kg/day in a 90-day toxicity study in rats. In addition, the reproductive indices were not affected in the two available developmental toxicity studies in rats.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for 2-methyl-2,4-pentanediol is not complete but considered as adequate for FQPA assessment given the low toxicity of 2-methyl-2,4-pentanediol. No guideline reproduction studies were available for assessment; however, no adverse effects on reproductive organs (including testes, prostate, seminal vesicles, epididymis, ovaries, vagina, and uterus) were observed in the 90-day gavage study in which rats were administered 2-methyl-2,4-pentanediol at doses up to 450 mg/kg/day. Therefore, OECD SIDS concluded that no additional studies are required under the SIDS program regarding fertility. EPA is in agreement with the OECD conclusion. Chronic studies are also not available, but the concern for chronic toxicity is low given the low toxicity of 2-methyl-2,4-pentanediol.

ii. No evidence of clinical signs of neurotoxicity was observed in the available database. No evidence of neurobehavioral or neuropathology was seen in a 90-day toxicity study in rats. There is no indication that 2-methyl-2,4-pentanediol is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that 2-methyl-2,4-pentanediol results in increased susceptibility in rats (as described in this unit).

iv Immunotoxicity studies for 2-methyl-2,4-pentanediol were not available for review. However, there was no evidence of immunotoxicity in the available database.

v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 percent crop treated (PCT) and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to 2-methyl-2,4-pentanediol in drinking water. These assessments will not underestimate the exposure and risks posed by 2-methyl-2,4-pentanediol.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute (aPAD) and chronic (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, 2-methyl-2,4-pentanediol is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to 2-methyl-2,4-pentanediol from food and water will utilize 3.8% of the cPAD for the U.S. population and Children 1-2 yrs of age 12.5% cPAD, the population group receiving the greatest exposure. Based on the explanation in this unit, regarding residential use patterns, chronic residential exposure to residues of 2-methyl-2,4-pentanediol is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

A short-term adverse effect was identified; however, 2-methyl-2,4-pentanediol is not currently used as an inert ingredient in pesticide products that are registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure resulting from use as an inert ingredient in pesticidal formulations and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for 2-methyl-2,4-pentanediol.

For the reasons discussed in Unit IV.C.3., short-term aggregate exposure assessment was not conducted for non-pesticidal uses.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, 2-methyl-2,4-pentanediol is not currently used as an inert ingredient in pesticide products that are registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for 2-methyl-2,4-pentanediol. For the reasons discussed in Unit IV.C.3., intermediate term aggregate exposure assessment was not conducted for non-pesticidal uses.

5. Aggregate cancer risk for U.S. population. 2-methyl-2,4-pentanediol is not expected to pose a cancer risk to humans. Therefore, aggregate cancer risk was not performed.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to 2-methyl-2,4-pentanediol residues.

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.

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. 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 2-methyl-2,4-pentanediol.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 and § 180.930 for 2-methyl-2,4-pentanediol. (CAS Reg. No. 107-1-41-5) when used as an inert ingredient in pesticide formulations applied to crops and food animals without limitations.

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 tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

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) (Pub. L. 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).

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS 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 site at http://www.gpoaccess.gov/ecfr.

Under FFDCA section 408(g), 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. 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-2008-0474 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 22, 2011. 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-2008-0474, 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 July 9, 2008 (73 FR 39291) (FRL-8371-2), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 8E7355) by Huntsman, 10003 Woodloch Forest Drive, The Woodlands, TX 77380; Dow AgroSciences L.L.C., 9330 Zionsville Road, Indianapolis, Indiana 46268; Nufarm Americas Inc., 150 Harvester Drive, Suite 220, Burr Ridge, Illinois, 60527; BASF, 26 Davis Drive, Research Triangle Park, NC 27709; Stepan Company, 22 W. Frontage Road, Northfield, IL 60093; Loveland Products Inc., PO Box 1286, Greeley, CO 80632; and Rhodia Inc., CN 1500, Cranbury, New Jersey, 08512. The petition requested that 40 CFR 180.920 be amended by establishing an exemption from the requirement of a tolerance for residues of DEGEE (CAS Reg. No. 111-90-0) when used as an inert ingredient, as a solvent, stabilizer and/or antifreeze in pesticide formulations applied to growing crops and raw agricultural commodities pre-harvest without limitation. That notice referenced a summary of the petition prepared by Huntsman, Dow AgroSciences L.L.C., Nufarm Americas Inc., BASF, Stepan Company, Loveland Products Inc., and Rhodia Inc., the petitioners, which is available in the docket, http://www.regulations.gov. The Agency received one comment in response to the notice of filing.

Currently, there is a tolerance exemption for DEGEE under 40 CFR 180.920 when it is used as a deactivator for formulations used before the crops emerge from the soil and stabilizer. This document provides an assessment of the risk to human health and the environment for DEGEE when used as a pesticide inert ingredient as a solvent, stabilizer and/or antifreeze within pesticide formulations/products without limitation.

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 DEGEE including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with DEGEE 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. Specific information on the studies received and the nature of the adverse effects caused by DEGEE as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

The following toxicity data on DEGEE were summarized from these sources, the World Health Organization (WHO), National Toxicology Program (NTP), Hazardous Substances Data Base (HSDB) and BIBRA Toxicology Advisory and Consulting (1976, 2003, respectively). DEGEE has low acute toxicity via oral and dermal routes. It is moderately irritating to the skin and is mildly irritating to the eye. It is not a skin sensitizer.

Several subchronic studies with DEGEE were available in rodents, ferrets and pigs. In rodents, toxicity was primarily manifested in the kidneys and liver. Increased kidney weights, tubular dilatation and centrilobular hepatocyte enlargement were seen at doses > 2,500 milligrams/kilogram/day (mg/kg/day). In ferrets, effects in the kidney were also observed. The concentrating power of the kidney was decreased and water intake was decreased at > 2.0 milliliter (mL)/kg/day (2,240 mg/kg/day). Kidney and liver effects were also observed in pigs. Kidney weights were increased, tubular hydropic degeneration and enlarged centrilobular and midzonal hepatocytes with pyknotic nuclei and fatty infiltration were observed at > 500 mg/kg/day.

A subchronic inhalation study with DEGEE in the rat was also available. No effects were observed at doses up to 1.1 milligrams/liter (mg/L) (approximately 314 mg/kg/day).

Several chronic carcinogenicity studies with DEGEE were available in rodents. However, these studies were conducted with a limited number of animals and doses and a complete histopathological examination was not performed. Due to these deficiencies, a definitive conclusion regarding carcinogenicity of DEGEE cannot be made on the basis of these studies. However, there were no obvious tumors detected in mice and rats.

Developmental studies with DEGEE in rodents were available for review. Fetal susceptibility was not observed in these studies. Parental (mortality and reduced body weight) and offspring (reduced mean pup birth weight) toxicity were observed in mice at the high dose (2,500 mg/kg/day). In a developmental toxicity study in rats via the dermal route of exposure, maternal toxicity was manifested as decreased body weight at 6,615 mg/kg/day. Developmental toxicity was not observed at this dose. In an inhalation developmental toxicity study in rats, maternal and developmental toxicity were not observed up to 100 parts per million (ppm) (approximately 31 mg/kg/day).

Two reproduction toxicity studies were available for review with DEGEE in rodents. One study in rats reported that increased urinary protein, bladder calculi, epithelial necrosis of the renal tubules and cloudy swelling of hepatic tissue were observed in all animals at 920 mg/kg/day of DEGEE with less than 0.2% of ethylene glycol. The NOAEL in this study was 200 mg/kg/day. In another study in mice, offspring toxicity (decreased live pup weights, decreased absolute brain and liver weights) and parental toxicity (increase water intake and decreased body weight in males) occurred at 2,500 mg/kg/day. There were no effects on reproductive parameters in either study.

Several mutagenicity studies (Ames test, micronucleus assay and unscheduled DNA synthesis) with DEGEE were available for review. One Ames test reported ambiguous results, another reported positive results at high doses. However, in vivo assays (micronucleus and unscheduled DNA synthesis) reported negative results. Therefore, based on the weight of evidence, DEGEE is not considered mutagenic.

As noted, available long-term carcinogenicity studies were considered inadequate to fully assess DEGEE's potential to cause cancer; however, these studies in mice and rats do not report any tumors. DEGEE belongs to the glycol ether class of chemicals which include structurally similar chemicals ethylene glycol (EG) and diethylene glycol (DEG). EG and DEG have toxicities similar to DEGEE. Target organs of toxicity are the kidney and liver. There was no evidence of carcinogenicity in rats and mice when treated with EG (NTP). Bladder tumors were observed in rats treated with DEG at >1,500 mg/kg/day, however, these tumors were secondary to irritation from bladder stones. The resulting classification for EG and DEG was that they are not expected to pose a carcinogenic risk in humans. Therefore, the carcinogenicity data on EG and DEG were used to assess the cancer potential of DEGEE. Based on the lack of evidence of carcinogenicity potential for EG and DEG, lack of tumors in mice and rats with DEGEE, and the fact that DEGEE is not mutagenic, DEGEE is not expected to be carcinogenic to humans. Also, the established chronic reference dose/chronic population adjusted dose (cRfD/cPAD) (2.0 mg/kg/day) for DEGEE will be protective of effects leading to kidney damage and tumor formation seen at >1,500 mg/kg/day following DEG exposures.

Immunotoxicity studies for DEGEE were not available for review. However, DEGEE belongs to the glycol ethers class of chemicals. Immunotoxicity studies were available for ethylene glycol mono butyl ether (DEGBE), also a glycol ether differing in only one ethyl and butyl group from DEGEE. These data were used to assess the immunotoxic potential of DEGEE. Signs of potential immunotoxicity were not observed in any of the available studies for the surrogate chemical. Nor was there evidence of immunotoxicity potential in any of the studies submitted for DEGEE. Therefore, DEGEE is not expected to be immunotoxic.

Dermal absorption studies were available with DEGEE. In a study using human epidermal membranes, the absorption rate of DEGEE was 0.206 mg/cm 2 /hr.

The available metabolism data in an adult human revealed that 68% of the administered dose of DEGEE was excreted in the urine as (2-ethoxy) acetic acid. In a metabolism study in the rabbit, oral or subcutaneous exposure to DEGEE resulted in the excretion of glucuronic acid in the urine; the major part of the dose was oxidized.

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.

A summary of the toxicological endpoints for DEGEE used for human risk assessment is shown in the following table.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to DEGEE, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from DEGEE in food as follows:

i. Acute exposure. No adverse effects attributable to a single exposure of DEGEE were seen in the toxicity databases. Therefore, an acute dietary exposure assessment for DEGEE is not necessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data were submitted for DEGEE. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentrations of active ingredient in agricultural products are generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

iii. Cancer. As discussed above, the Agency has not identified any concerns for carcinogenicity relating to DEGEE, and, therefore, a dietary exposure assessment to assess cancer risk is unnecessary.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for DEGEE, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

3. 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).

DEGEE may be used in inert ingredients in products that are registered for specific uses that may result in residential exposure. A screening level residential exposure and risk assessment was completed for products containing DEGEE as inert ingredients. The Agency selected representative scenarios, based on end-use product application methods and labeled application rates. The Agency conducted an assessment to represent worst-case residential exposure by assessing DEGEE in pesticide formulations (Outdoor Scenarios) and DEGEE in disinfectant-type uses (Indoor Scenarios). The Agency is not aware of any use of DEGEE in hard surface cleaning products. However, this scenario was used for this assessment considering wide use of DEGEE in other products. Therefore, the Agency assessed the disinfectant-type products containing DEGEE using exposure scenarios used by the Antimicrobials Division in EPA's Office of Pesticide Programs to represent worst-case residential handler exposure. Further details of this residential exposure and risk analysis can be found at http://www.regulations.gov in the memorandum entitled: “JITF Inert Ingredients. Residential and Occupational Exposure Assessment Algorithms and Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations,” (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.

In addition to pesticidal uses for DEGEE, there are non-pesticidal uses for DEGEE. However, dermal and inhalation exposure are expected to be negligible; therefore, a quantitative exposure assessment was not conducted.

4. 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 DEGEE to share a common mechanism of toxicity with any other substances, and DEGEE does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that DEGEE 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 Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. 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 FQPA Safety Factor (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.

2. Prenatal and postnatal sensitivity. Fetal susceptibility was not observed in the developmental toxicity studies with DEGEE in the mouse. Developmental studies were available via the oral (mice), dermal (rats) and inhalation (rats) routes of exposure in rodents. Following oral exposure to DEGEE, maternal (mortality and reduced body weight) and offspring (reduced mean pup birth weight) toxicity were observed in mice at the high dose (2,500 mg/kg/day). Following dermal exposure to DEGEE, maternal toxicity was manifested as decreased body weight at 6,615 mg/kg/day in rats. Developmental toxicity was not observed at this dose. Following inhalation exposure to DEGEE, maternal and developmental toxicity were not observed up to 100 ppm (approximately 31 mg/kg/day) in rats. A developmental toxicity study in rabbits is not available in the database. However, the concern for the lack of this study is low because toxicity was observed near the limit dose in the developmental and reproduction studies in rodents (>920 mg/kg/day).

Evidence of increased fetal susceptibility was observed in a reproduction toxicity study in the mice. Offspring toxicity was manifested as decreased adjusted live pup weight and absolute brain weights and increased liver weights in the absence of parental toxicity. There is no concern for this increased susceptibility in mice because these pup effects were observed at a dose 2.5 times above the limit dose of 1,000 mg/kg/day and a clear NOAEL was established in the study. It is unclear if there is fetal susceptibility in the reproduction toxicity study in rats. In this study, it was stated that increased urinary protein, bladder calculi, epithelial necrosis of the renal tubules and cloudy swelling of hepatic tissue were observed in all animals at 920 mg/kg/day (NOAEL 200 mg/kg/day). It is not clear whether all animals referred in the study include both the parental and F1 animals or not. However, in any case the concern for fetal susceptibility is low because the aforementioned effects occured near the limit dose and the cRfD (2.0 mg/kg/day) will be protective of these effects.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for DEGEE is adequate for FQPA assessment. The following acceptable studies are available: Developmental and reproduction toxicity studies in mice and rats, subchronic and mutagenicity studies. A 2-generation reproduction toxicity study where tumors were evaluated is available. Also, chronic/carcinogenicity studies are available on a surrogate chemical, ethylene glycol. A developmental toxicity study in rabbits is not available in the database. However, the concern for the lack of this study is low because toxicity was observed at or above the limit dose in the developmental and reproduction studies in rodents.

ii. Signs of neurotoxicity were not observed in a reproduction toxicity study in rats. Decreased absolute brain weights were observed in the offspring at 2,500 mg/kg/day. However, a developmental neurotoxicity study is not required because decreased brain weights were observed above the limit dose (1,000 mg/kg/day), the effect occurred in the presence of maternal toxicity and the cRfD (2.0 mg/kg/day) will be protective of this effect. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is evidence that DEGEE results in increased fetal susceptibility in the multi-generation reproduction study in the mouse. However, the concern for fetal susceptibility is low because the effects seen in the offspring (adjusted live pup weight and absolute brain weights and increased liver weights) occur at 2,500 mg/kg/day (2.5times the limit dose), the effects occur in the absence of maternal toxicity, a clear NOAEL (1,250 mg/kg/day) was established and the cRfD (2.0 mg/kg/day) will be protective of these effects.

iv. Immunotoxicity studies for DEGEE were not available for review. However, DEGEE belongs to the glycol ethers class of chemicals. Immunotoxicity studies were available for ethylene glycol monobutyl ether, also a glycol ether. This data were used to assess the immunotoxic potential of DEGEE. Signs of potential immunotoxicity were not observed in any of the available studies for the surrogate chemical. Nor was there evidence of immunotoxicity potential in any of the studies submitted for DEGEE. Therefore, DEGEE is not expected to be immunotoxic.

v. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% crop treated (CT) and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to DEGEE in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by DEGEE.

Determination of safety section. EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, DEGEE is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to DEGEE from food and water will utilize 0.10% of the cPAD for the general U.S. population and 0.31% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in this unit, regarding residential use patterns, chronic residential exposure to residues of DEGEE is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

DEGEE is currently used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to DEGEE.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 264 for both adult males and females, respectively. Adult residential exposure combines high end dermal and inhalation handler exposure from homeowner mixer/loader/applicators using a trigger sprayer with a high end post application dermal exposure from contact with treated lawns. As the level of concern is for MOEs that are lower than 100, this MOE is not of concern. EPA has concluded that the combined short-term aggregated food, water, and residential exposures result in an aggregate MOE of 228 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's level of concern for DEGEE is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

DEGEE is currently used as an inert ingredient in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to DEGEE.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 777 for adult males and females. Adult residential exposure combines high end dermal and inhalation handler exposure from homeowner mixer/loader/applicators using a trigger sprayer with a high end post application dermal exposure from contact with treated lawns. EPA has concluded the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 267 for children. Children's residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's level of concern for DEGEE is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. DEGEE is not expected to pose a carcinogenic risk in humans based on the discussion in Unit IV.A.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to DEGEE residues.

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.

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. 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 DEGEE.

The comment was received from private citizens 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 Federal Food, Drug and Cosmetic Act (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 the statute.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.920 for DEGEE (CAS Reg. No. 111-90-0) when used as an inert ingredient (as a solvent, stabilizer and/or antifreeze within pesticide formulations/products without limitation) in pesticide formulations applied to growing crops and raw agricultural commodities pre-harvest.

This final rule establishes an exemption from 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 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, 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) (Pub. L. 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).

Therefore, 40 CFR chapter I is amended as follows:

I. General Information A. Does this action apply to me?

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 site at http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 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. 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-2011-0517 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 22, 2011. 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-2011-0517, 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 January 25, 2006 (71 FR 4135) (FRL-7750-4) for C 9 rich aromatic hydrocarbons, January 23, 2006 (71 FR 3512) (FRL-7750-3) for C 10-11 rich aromatic hydrocarbons, and February 1, 2006 (71 FR 5321) (FRL-7750-5) for C 11-12 rich aromatic hydrocarbons, EPA issued notices pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of pesticide petitions (PP 5E6935, 5E6934, and 4E6937 respectively) by ExxonMobil Chemical Company, 13501 Katy Freeway, Houston, TX 77079. The petitions requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of C 9 rich aromatic hydrocarbons (CAS Reg. No. 64742-95-6), C 10-11 rich aromatic hydrocarbons (CAS Reg. No. 64742-94-5), and C 11-12 rich aromatic hydrocarbons (CAS Reg. No. 64742-94-5) when used as inert ingredients (solvents) in pesticide formulations applied to raw agricultural commodities and growing crops under 40 CFR 180.910. Those notices referenced summaries of the petitions prepared by ExxonMobil, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notices of filing.

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 C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons 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.

C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are products of the petroleum distillation and refining process. These substances are various fractions of aromatic petroleum hydrocarbons with specific boiling point ranges and flash points. Each of the substances is comprised of a complex mixture of aromatic hydrocarbon molecules in the range of 9 to 12 carbon atoms. Since C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons differ only in the proportions of the various hydrocarbon molecules within the C 9 to C 12 range, they have similar physicochemical and toxicological properties and have therefore been assessed together.

C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons exhibit low acute toxicity by oral, inhalation and dermal routes (toxicity Category III or IV by all exposure routes). They are minimally irritating to eyes and skin and negative for dermal sensitization effects. Subchronic oral and inhalation toxicity studies indicate these substances to be relatively non-toxic. Reversible effects to the liver, thyroid, stomach, spleen, and urinary bladder were reported at mid and high doses in a subchronic oral toxicity study in rats. A developmental inhalation study in mice indicates no evidence of developmental effects or any adverse effects in maternal animals at dose levels below 715 milligrams/kilogram/day (mg/kg/day). An oral developmental study in rats indicates maternal effects (decreased body weight gain and food consumption) at the mid-dose (150 mg/kg/day) but no developmental effects at the highest dose tested (450 mg/kg/day). An inhalation reproduction study in rats indicates reduced body weight gain in parents and offspring at mid and high doses (715 and 2,145 mg/kg/day). Based on neurotoxicity studies, C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are not expected to cause any nervous system damage. Due to their complex, multi-constituent nature, there are no substance-specific absorption, metabolism, distribution and excretion studies done specifically on C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons. However, sufficient metabolism data are available on other aromatic hydrocarbons to show that as a class they are typically well-absorbed, widely distributed between tissues, extensively metabolized and rapidly excreted. C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are of low toxicological concern for developmental and reproductive effects, based on the available toxicity data, and are not expected to be carcinogenic.

Specific information on the studies received and the nature of the adverse effects caused by C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons 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 “Exemptions From the Requirement of a Tolerance for C9 Rich Aromatic Hydrocarbons, C10-11 Rich Aromatic Hydrocarbons, C11-12 Rich Aromatic Hydrocarbons,” at pp 5-17 in docket ID number EPA-HQ-OPP-2006-0517.

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.

A summary of the toxicological endpoints for C 9 rich aromatic hydrocarbons, C 10 - 11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons used for human risk assessment is shown in the following Table.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons in food as follows:

i. Acute exposure. In conducting the acute dietary exposure assessment for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons, EPA used food consumption information from the U.S. Department of Agriculture (USDA) [1994-1996 and 1998] Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data were submitted for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredients. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data can be found at http://www.regulations.gov in the document “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,” in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. The concentrations of active ingredient in agricultural products are generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product relative to that of the active ingredient.

Second, the conservatism of this methodology is compounded by EPA's decision to assume that, for each commodity, the active ingredient which will serve as a guide to the potential level of inert ingredient residues is the active ingredient with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA's assumption that all foods contain the inert ingredient at the highest tolerance level, i.e., EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner necessary to produce the highest residue legally possible for an active ingredient. In summary, EPA chose a very conservative method for estimating what level of inert residue could be on food, and then used this methodology to choose the highest possible residue that could be found on food and assumed that all food contained this residue. No consideration was given to potential degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typically one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to quantify actual residue levels in food is not available, the compounding of these conservative assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons, EPA used food consumption information from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, no residue data were submitted for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound chronic dietary exposure estimates for the subject inert ingredient. This approach is as described in Unit IV. C.1.i.

iii. Cancer. The Agency used a qualitative structure activity relationship (SAR) database, DEREK11, to determine if there were structural alerts suggestive of carcinogenicity. No structural alerts for carcinogenicity were identified. Therefore, a cancer dietary exposure assessment is not necessary to assess cancer risk.

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons, a conservative drinking water concentration value of 100 parts per billion (ppb) based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments. These values were directly entered into the dietary exposure model.

3. 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).

C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are not currently used as inert ingredients in pesticide products that are registered for any use patterns that involve residential uses nor are there any other non-pesticidal residential uses for these inert ingredients, thus no residential exposures to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are expected. The primary non-pesticidal uses of C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are as gasoline additives. Residential exposures to these substances as a result of their use as gasoline additives could occur via inhalation during refueling and from potential transport of gasoline containing C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons into groundwater. There are no reliable data upon which to quantitatively assess such exposures to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons; however, modeled data for other gasoline additives suggest that inhalation exposures would be at levels of <5 micrograms/kilogram/day, and that levels in groundwater would not exceed 0.2-16 ppb.

4. 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 C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons to share a common mechanism of toxicity with any other substances, and C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons do 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 Web site at http://www.epa.gov/pesticides/cumulative.

1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10×) 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 FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10×, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. The available mammalian toxicology database for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons is complete with respect to assessing increased susceptibility to infants and children. There were no adverse effects on the offspring of rats following prenatal and postnatal exposure in the OCSPP Harmonized Test Guideline 870.3700 oral developmental toxicity study at the highest dose tested of 450 mg/kg/day. In a 3-generation inhalation toxicity study in rats, reproductive effects were seen only at dose levels above that at which parental effects were noted.

3. Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1×. That decision is based on the following findings:

i. The toxicity database for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons is largely complete, missing only a developmental neurotoxicity study and an immunotoxicity study. EPA has determined that an additional uncertainty factor is not needed to account for the lack of these studies for the following reasons:

• There were no neurotoxic effects observed at the highest dose tested in a 90-day inhalation neurotoxicity study in rats with a C 9 aromatic hydrocarbon material. There is no evidence that C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

• There is no evidence that C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons result in increased susceptibility in in utero rats in the prenatal developmental studies or in young rats in a 3-generation reproduction study.

• An immunotoxicity study is not available; however, there is no evidence of immune system involvement in the available toxicity database for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons, therefore, there is no need to add additional UFs to account for the lack of an immunotoxicity study.

ii. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 percent crop treated (PCT) and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons in drinking water. These assessments will not underestimate the exposure and risks posed by C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons will occupy 2.8% of the aPAD for children (1 to 2 years old), the population group receiving the greatest exposure. Therefore, C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons from food and water will utilize 0.6% of the cPAD for children (1 to 2 years old), the population group receiving the greatest exposure. There are no residential pesticide uses for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons. As noted in Unit IV.C.3., non-pesticidal drinking water exposure to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons may be possible from potential transport of gasoline containing C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons into groundwater; however, those potential exposures are addressed by the use of a conservative drinking water concentration value of 100 ppb used to assess the contribution to drinking water for the chronic dietary risk assessments, therefore no further assessment of this potential exposure is needed.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). A short-term adverse effect was identified; however, C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are not currently used as inert ingredients in pesticide products that are registered for any use patterns that would result in short-term residential exposure. Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short-term risk for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons. As noted in Unit IV.C.3., there may be short-term inhalation exposures to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons when these substance are present as gasoline additives during gasoline refueling, however those exposures would be expected to be at levels at least three orders of magnitude below any level of concern and therefore have not been included in a quantitative short-term risk assessment.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). An intermediate-term adverse effect was identified; however, C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are not currently used as inert ingredients in pesticide products that are registered for any use patterns that would result in intermediate-term residential exposure. Intermediate-term risk is assessed based on intermediate-term residential exposure plus chronic dietary exposure. Because there is no intermediate-term residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess intermediate-term risk), no further assessment of intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating intermediate-term risk for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons.

5. Aggregate cancer risk for U.S. population. The Agency has not identified any concerns for carcinogenicity relating to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons and C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons are not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons residues.

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.

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. 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 MRLs for C 9 rich aromatic hydrocarbons, C 10-11 rich aromatic hydrocarbons, and C 11-12 rich aromatic hydrocarbons.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180. 910 for residues of C 9 rich aromatic hydrocarbons (CAS Reg. No. 64742-95-6), C 10-11 rich aromatic hydrocarbons (CAS Reg. No. 64742-94-5), and C 11-12 rich aromatic hydrocarbons (CAS Reg. No. 64742-94- 5) when used as inert ingredients in pesticide formulations applied to growing crops or to raw agricultural commodities after harvest.

This final rule establishes exemptions from tolerance under section 408(d) of FFDCA in response to petitions 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) (Pub. L. 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).

Therefore, 40 CFR chapter I is amended as follows:

EPA is publishing this rule without prior proposal because we view this as a non-controversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of today's Federal Register publication, we are publishing a separate document that will serve as the proposed rule to adopt the provisions in this Direct Final rule if adverse comments are filed. We will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. If we receive one or more adverse comments on this correction, we will publish a timely withdrawal in the Federal Register to notify the public that the amendment in this Direct Final rule that will not take effect. For further information about commenting on this rule, see the ADDRESSES section of this document.

Entities potentially affected by this action are the hazardous waste manifest printers subject to 40 CFR 262.21(f) of the RCRA hazardous waste regulations. States are not affected by the changes to the printing specifications unless they opt to print manifests. No states are currently printing these forms.

1. Tips for Preparing Your Comments. When submitting comments, remember to:

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

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

• Explain why you disagree, suggests alternatives, and substitute language for your requested changes.

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

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

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

• Explain your views as clearly as possible. Make sure to submit your comments by the comment period deadline identified.

This rule is authorized under Sections 1004 and 3002 of the Resource Conservation and Recovery Act (RCRA) of 1976, as amended, 42 U.S.C. 6903 and 6922.

Today's action amends 40 CFR 262.21(f)(4) in order to revise the regulatory language that currently requires that the manifest copy distribution notations (printed in the bottom right-hand corner of each page of the manifest) be printed only in red ink. EPA is amending this paragraph by revising it to read: “The manifest and continuation sheet must be printed in black ink that can be legibly photocopied, scanned, or faxed, except that the marginal words indicating copy distribution must be printed with a distinct ink color or with another method ( e.g., white text against black background in a text box, or, black text against grey background in a text box) that clearly distinguishes the copy distribution notations from the other text and data entries on the form.” This is the only manifest printing specification that we are revising in this Direct Final rule.

EPA adopted a nationally standardized manifest form during the promulgation of the March 4, 2005 Manifest Form Revisions Rule (70 FR 10776 et seq. ) in order to replace the various State manifest forms that were previously distributed to users by the RCRA authorized States. The March 2005 rule also established the Manifest Registry system to ensure that authorized printers: (1) Produced the manifest form and continuation sheet with unique manifest tracking numbers pre-printed on them; and (2) adhered to the prescribed Federal printing specifications. The Manifest Revisions Rule generally required in 40 CFR 262.21(f)(4) that the manifest form be printed in black ink, except that certain marginal notations identifying the copy distribution requirements must be printed in red ink on all six copies of the multi-paged form. EPA specified the red ink requirement for the copy distribution notations was based on comments received on the May 2001 proposed rule notice. That is, while a number of commenters agreed that manifest printers should use black ink to print the form, several commenters suggested that the marginal notations should appear in red ink, because that ink color would help call attention to the copy distribution requirements and distinguish them from the remainder of the printed form entries.

While the red ink requirement for the copy distribution notations seemed sensible when we promulgated the final rule in 2005, EPA now believes that the red ink requirement is too prescriptive, and may prevent printers from utilizing new printing processes and methods. For example, EPA recently received an application from a hazardous waste management company that wished to print its own manifest forms using laser printers mounted on its transport vehicles. While the applicant was able to comply with nearly all of the Manifest Registry application requirements and printing specifications prescribed in § 262.21(f), the applicant could not easily comply with the aforementioned red ink requirement, while printing and assembling manifests on its transport vehicles. This difficulty resulted because the laser printers proposed for use in this mobile application could not produce red print. The applicant demonstrated with this application, however, that it could easily implement a highlighting method that had the desired effect of setting off the copy distribution notations from the other printed entries on the form. This application provided a good example of how the requirement in § 262.21(f) for red ink was unnecessarily prescriptive, and that an amendment would make sense. EPA believes that today's amendment will allow manifest printers greater flexibility in complying with the printing specifications, without incurring any additional costs or compromising in any way the ability of the manifest forms to track hazardous waste shipments cradle-to-grave. EPA believes that this is a very minor and non-controversial change to the printing specifications, and therefore is an appropriate subject for a Direct Final rule.

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

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

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

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

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

OMB has determined that this rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). Accordingly, EPA did not submit this action to OMB for review.

This action does not impose any new information collection burden. This action provides additional flexibility to printers of the hazardous waste manifest by giving these printers additional options for printing in the margins of the manifest the copy distribution requirements for the form. While this action provides the printers with additional flexibility when printing the manifest form, it will impose no new information collection burdens on the generators, transporters, or treatment, storage, disposal, or recycling facilities that are required to use the manifest to track shipments of hazardous waste.

OMB has previously approved the information collection requirements contained in the existing manifest regulations at 40 CFR part 262, subpart B, under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control number 2050-0039. A copy of the OMB approved Information Collection Request (ICR) may be obtained from the Collection Strategies Division, U.S. EPA (2822T), 1200 Pennsylvania Ave., NW., Washington, DC 20460 or by calling (202) 566-1672.

Burden is defined at 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.

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

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

After considering the economic impacts of today's Direct Final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This rule consists only of a minor technical change to the manifest printing specifications, and the effect of this change is to make it easier for printers to comply with the manifest printing specification by providing additional options. Therefore, this rule does not impose any new burden or costs on printers or users of the manifest, including printers and users who are small entities as defined by the RFA. Since the rule will not have any significant adverse economic impact on small entities, the RFA does not require EPA to perform a regulatory flexibility analysis.

This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538 for State, local, or Tribal governments or the private sector.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of the regulatory actions on state, local, and Tribal governments and on the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures to state, local, and Tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed, section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objective of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective or least burdensome alternative if the Administrator publishes with the final rule an explanation why that alternative was not adopted.

Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including Tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.

This action does not contain any “Federal intergovernmental mandates” or any “Federal private sector mandates” subject to Title II of the UMRA. This Direct Final rule simply makes a minor change that allows hazardous waste manifest printers more flexibility in meeting the printing specifications for the hazardous waste manifest form. The Manifest Registry program under which printers may register to print the hazardous waste manifest is a voluntary Federal program. Currently, there are no states, local governments, or Tribal governments involved with printing the manifest, but even if such a governmental agency elected to print the manifest, it would do so by participating in the voluntary Manifest Registry Program. The UMRA generally excludes from the definition of “Federal intergovernmental mandate” and the definition of “Federal private sector mandate” those duties that arise from participation in a voluntary Federal program. Since all participants in the Manifest Registry for printers do so voluntarily, this action is not subject to the requirements of sections 202 or 205 of the UMRA. This action is also not subject to the requirements of section 203 of the UMRA, because it contains no regulatory requirements that might significantly or uniquely affect small governments. This action only affects hazardous waste manifest printers, and there are no small governments involved with printing the manifest. Thus, small governments are not significantly or uniquely affected by this action.

This action does not have Federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This action is only a minor regulatory change affecting the specifications under which hazardous waste manifest printers must print the manifest form. It does not impose substantial direct compliance costs. While the Federal printing specifications for manifest printers preclude States from requiring a different manifest form or different printing specifications, this preemptive effect arises under the RCRA consistency requirement for the manifest at 40 CFR 271.4 and from the uniformity requirements for the use of shipping papers under the Department of Transportation's Hazardous Materials transportation laws. The requirement for consistency and uniformity in the manifest, including the manifest printing specifications, was explained in the Manifest Revisions Rule that EPA published in the March 4, 2005 Federal Register (70 FR 10776). The minor change to the printing specifications announced in today's rule will provide some additional flexibility for manifest printers to print the copy distribution notations on the form.

Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249), requires EPA to develop a process to ensure “meaningful and timely input by Tribal officials in the development of regulatory policies that have Tribal implications,” as specified in Executive Order 13175. It will neither impose substantial direct compliance costs on Tribal governments, nor preempt Tribal law. This action has no effect on Tribal governments, as it only makes a minor change to the printing specifications that affect only entities printing the hazardous waste manifest. No Indian Tribes are involved with the printing of the hazardous waste manifest; nor are there any Indian Tribes with authorized Hazardous Waste regulatory programs that might have their own printing specifications for the hazardous waste manifest. Thus, Executive Order 13175 does not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997). This action is not economically significant within the meaning of Executive Order 12866. Further, the action amends an administrative requirement pertaining to the manifest form, so it does not give rise to any environmental health or safety risks that could disproportionately affect children.

This rule is not subject to Executive Order 13211, “Actions That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

Section 12(d) of the National Technology and Advancement Act of 1995 (NTTAA), Public Law No. 104—113, section 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards ( e.g., material specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through the OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This action amends the hazardous waste manifest printing specifications which are developed and maintained solely by EPA. When EPA initially published the manifest printing specifications in March 2005, there were no potentially applicable voluntary consensus standards for manifest printers. EPA decided to develop the current printing specifications, which now prescribe the standards applicable to manifest printers. With this action, EPA is retaining and amending the Federal standards developed in the 2005 Manifest Revisions Rule.

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this Direct Final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because this rule simply makes a minor change to the hazardous waste manifest printing specifications. No minority or low-income population will be affected by this change.

The Congressional Review Act, 5 U.S.C. 801 et. seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other information required by the Congressional Review Act to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register . Under this Act, a major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2). This Direct Final rule will be effective on August 22, 2011, unless EPA receives an adverse comment by July 22, 2011 and thereafter withdraws this direct final action.

40 CFR part 262 is amended as follows:

On September 13, 2010, the Secretary published in the Federal Register (75 FR 55503, September 13, 2010) an NPRM to revise and amend the Table by moving these vaccines to separate and distinct listings of the Table. The NPRM was issued pursuant to Section 2114(e) of the Act, which directs the Secretary to add to the Table, by rulemaking, coverage of additional vaccines which are recommended by the Centers for Disease Control and Prevention for routine administration to children.

The Department held a 6-month comment period, which ended on March 14, 2011, in connection with this NPRM. The Secretary received one non-substantive comment that was not responsive to the NPRM. A public hearing was held on March 4, 2011, as announced in the Federal Register (76 FR 8965, February 16, 2011), but no individual or organization appeared to testify.

Because the Secretary has not received any substantive comments, either written or oral, from any interested individual or organization on the proposals made in the NPRM, and because the Secretary continues to believe the advisability of effectuating such proposals, this final rule implements the proposals made in the NPRM. The rationale for all revisions were explained fully in the Preamble to the NPRM. For the reasons set forth in the NPRM, the Secretary amends the Table in this final rule.

Executive Order 12866, as amended by Executive Orders 13258 and 13422, directs agencies to assess all costs and benefits of available regulatory alternatives and, when rulemaking is necessary, to select regulatory approaches that provide the greatest net benefits (including potential economic, environmental, public health, safety, distributive and equity effects). In addition, under the Regulatory Flexibility Act, if a rule has a significant economic effect on a substantial number of small entities, the Secretary must specifically consider the economic effect of a rule on small entities and analyze regulatory options that could lessen the impact of the rule. Executive Order 12866, as amended by Executive Orders 13258 and 13422, requires that all regulations reflect consideration of alternatives, of costs, of benefits, of incentives, of equity, and of available information. Regulations must meet certain standards, such as avoiding an unnecessary burden. Regulations which are “significant” because of cost, adverse effects on the economy, inconsistency with other agency actions, effects on the budget, or novel legal or policy issues, require special analysis.

The Secretary has determined that no resources are required to implement the requirements in this final rule. Therefore, in accordance with the Regulatory Flexibility Act of 1980 (RFA), and the Small Business Regulatory Enforcement Fairness Act of 1996, which amended the RFA, the Secretary certifies that this final rule will not have a significant impact on a substantial number of small entities.

The Secretary has also determined that this final rule does not meet the criteria for a major rule as defined by Executive Order 12866, as amended by Executive Orders 13258 and 13422, and would have no major effect on the economy or Federal expenditures. The Secretary has determined that this final rule is not a “major rule” within the meaning of the statute providing for Congressional Review of Agency Rulemaking, 5 U.S.C. 801.

Similarly, it will not have effects on State, local, and Tribal governments and on the private sector such as to require consultation under the Unfunded Mandates Reform Act of 1995.

The Secretary has reviewed this final rule in accordance with Executive Order 13132 regarding federalism, and has determined that it does not have “federalism implications.” This final rule would not “have substantial direct effects on the States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.”

This final rule would not adversely affect the following family elements: Family safety, family stability, marital commitment; parental rights in the education, nurture and supervision of their children; family functioning, disposable income or poverty; or the behavior and personal responsibility of youth, as determined under section 654(c) of the Treasury and General Government Appropriations Act of 1999.

This final rule is technical in nature. Because the vaccines being added to the Table as separate categories are already included on the Table under Category XIII, this Table will have no effect on current or potential petitioners other than to help clarify which vaccines are covered by the VICP. This final rule would not prevent otherwise eligible individuals with claims of injuries or deaths allegedly resulting from the hepatitis A, trivalent influenza, meningococcal and human papillomavirus vaccines from filing claims with the VICP and would not otherwise affect such petitioners.

This final rule does not have any information collection requirements.

Accordingly, 42 CFR part 100 is amended as set forth below:

The NFIP enables property owners to purchase flood insurance which is generally not otherwise available. In return, communities agree to adopt and administer local floodplain management aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage as authorized under the NFIP, 42 U.S.C. 4001 et seq.; unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. However, some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue their eligibility for the sale of insurance. A notice withdrawing the suspension of the communities will be published in the Federal Register .

In addition, FEMA has identified the Special Flood Hazard Areas (SFHAs) in these communities by publishing a Flood Insurance Rate Map (FIRM). The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may legally be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year, on FEMA's initial flood insurance map of the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and public comment under 5 U.S.C. 553(b) are impracticable and unnecessary because communities listed in this final rule have been adequately notified.

Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.

National Environmental Policy Act. This rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Considerations. No environmental impact assessment has been prepared.

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This rule meets the applicable standards of Executive Order 12988.

Paperwork Reduction Act. This rule does not involve any collection of information for purposes of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

Accordingly, 44 CFR part 64 is amended as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 67 is amended as follows: