This interim rule is published pursuant to 7 U.S.C. 2008j as amended by section 11009 of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246) and will create a new part 63 in Title 7 of the Code of Federal Regulations for the establishment and function of the NSIIC.

This interim rule has been determined to be not significant for the purposes of Executive Order 12866 and therefore, has not been reviewed by the OMB.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State and local governments and the private sector. Under section 202 of the UMRA, the AMS generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures by State and local governments, in the aggregate, or by the private sector, of $100 million or more in any one year (2 U.S.C. 1532). When such a statement is needed for a rule, section 205 of the UMRA generally requires Federal agencies to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule (2 U.S.C. 1535). This rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State and local governments or the private sector of $100 million or more in any one year. Therefore, this rule is not subject to the requirements of sections 202 and 205 of the UMRA.

This interim rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have any retroactive effect. There are no administrative proceedings that must be exhausted before parties may file in court.

This interim rule has been reviewed under Executive Order 13132, Federalism, and has been determined that this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Assessment. The provisions contained in this rule would not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various levels of government.

In accordance with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the agency is required to examine the impact of regulatory actions on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened. AMS certifies that this rule will not have a significant impact on a substantial number of small entities as defined in the RFA.

The purpose of the NSIIC is to: (1) Promote strategic development activities and collaborative efforts by private and State entities to maximize the impact of Federal assistance to strengthen and enhance the production and marketing of sheep or goat products in the United States; (2) Optimize the use of available human capital and resources within the sheep or goat industries; (3) Provide assistance to meet the needs of the sheep or goat industry for infrastructure development, business development, production, resource development, and market and environmental research; (4) Advance activities that empower and build the capacity of the U.S. sheep or goat industry to design unique responses to the special needs of the sheep or goat industries on both a regional and national basis; and (5) Adopt flexible and innovative approaches to solving the long-term needs of the United States sheep or goat industry.

A Board of Directors will manage and be responsible for the general supervision of the structure of the NSIIC, with oversight from USDA. The Board is comprised of seven voting members, of whom four would be active producers of sheep or goats in the United States, two would have expertise in finance and management, and one would have expertise in lamb, wool, goat, or goat product marketing. The Secretary would appoint the voting members from nominations submitted by eligible organizations. There also would be two non-voting members on the Board, the Under Secretary of Agriculture for Rural Development (RD) and the Under Secretary of Agriculture for Research, Education, and Economics.

This rule provides opportunity for public, private, or cooperative organizations; associations, including corporations not operated for profit; federally recognized Indian Tribes; public or quasi-public agencies to be considered eligible entities to submit grant proposals to the Board. According to various sheep and goat association Web sites, there are approximately 215 regional, State, and national sheep and goat organizations located throughout the United States. In addition, according to the Department of the Interior's August 11, 2009, Federal Register (74 FR 40218); there are approximately 564 federally recognized American Indian Tribes in the United States.

According to the 2007 Census of Agriculture, there were 83,134 farms with sheep and lamb and 144,466 farms with goats in the United States. Thus, at least approximately 227,600 sheep, lamb and goat producers potentially would be eligible to serve on the four producer positions on the Board of NSIIC. Two positions on the Board are for persons with expertise in finance and management, while one position is for a person with expertise in lamb, wool, goat, or goat product marketing. It is estimated that not more than 10 national organizations would be eligible to nominate the voting members of the Board to the Secretary for appointment.

Most producers would be classified as small businesses under the criteria established by the Small Business Administration (13 CFR 121.201). The members of the national organizations would be expected to reflect this same size. The SBA defines small agricultural service firms as those whose annual receipts are less than $7 million, and small agricultural producers are defined as those having annual receipts of not more than $750,000 annually. With regard to persons who have expertise in finance and management or expertise in lamb, wool, goat, or goat product marketing, and other eligible entities, AMS does not have specific information on the number and size of all such persons or entities and requests comments providing pertinent information or data. Nonetheless, we would estimate that a number of such persons would be considered small entities.

The information collection burden is discussed in the following section.

In accordance with the PRA, this interim rule announces that AMS is requesting review and approval from OMB of a new information collection. AMS has based these estimates on industry research and experience with other boards and advisory committees. The proposed forms are necessary to appoint a Board to effectively carry out the requirements of the enabling legislation—including seating a Board. The nomination process is not expected to have a significant impact on persons affected. The overall impact of the NSIIC program under the Act is expected to be beneficial to sheep and goat industries.

The proposed forms have been carefully reviewed, and every effort has been made to minimize any unnecessary recordkeeping costs or requirements. Such information can be supplied without data processing equipment or outside technical expertise. There are no additional training requirements for individuals filling out reports to the Board. The forms would be simple and easy to understand and place as small a burden as possible on the person required to file the information. In addition, the information to be included on these forms is not available from other sources because such information relates specifically to individual producers or industry members who are nominated to the Board. Therefore, there is no practical method for collecting the required information without the use of these forms.

Title: National Sheep Industry Improvement Center.

OMB Number: 0581-NEW.

Expiration Date of Approval: 3 years from date of OMB approval.

Type of Request: Approval of a new information collection.

Abstract: The primary objective of the NSIIC is to assist U.S. sheep and goat industries by strengthening and enhancing the production and marketing of sheep, goats, and their products in the United States. The information collection requirements in the request are essential to carry out the intent of the enabling legislation.

AMS will accept nominations for membership on the Board from national organizations that (1) consist primarily of active sheep or goat producers in the United States and (2) have the primary interest of sheep or goat production in the United States. A nomination for appointment form would be submitted by such national organizations (who may submit more than one nominee) while a background information form and nominee's agreement to serve form would be submitted by each producer or industry member nominated to serve on the Board.

Estimate of Burden: The public reporting and recordkeeping burden for this collection of information is estimated to total 40 hours the first year and 16 hours each year after. We will submit a justification for change to report new burden hours added to form AD-755.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 0.5 hour per response.

Respondents: National organizations submitting nominations to the Board who (1) consist primarily of active sheep or goat producers in the United States and (2) have the primary interest of sheep or goat production in the United States.

Estimated number of Respondents: 10.

Estimated number of Responses per Respondent: 1 per year.

Estimated Total Annual Burden: 5 hours.

Estimate of Burden: Public reporting for this collection of information is estimated to average 0.5 hour per response for each producer or industry member nominated to serve on the Board.

Respondents: Sheep or goat producers; Persons with expertise in finance and management; and Persons with expertise in lamb, wool, goat, or goat marketing.

Estimated number of Respondents: (56 for initial nominations to the NSIIC Board, about 18 in the second year, about 18 in the third year).

Estimated number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 28 hours for the initial nominations to the NSIIC Board and approximately 9 hours annually thereafter.

Estimate of Burden: Public reporting for this collection of information is estimated to average .125 hours per response for each producer or industry member nominated to serve on the Board.

Respondents: Sheep or goat producers; Persons with expertise in finance and management; and Persons with expertise in lamb, wool, goat, or goat marketing.

Estimated Number of Respondents: (56 for initial nominations to the NSIIC Board, about 18 in the second year, about 18 in the third year).

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 7 hours for the initial nominations to the NSIIC Board and approximately 2.25 (rounded down to 2) hours annually thereafter.

Comments are invited on: (1) Whether the new collection of information is necessary for the proper performance of the functions of the NSIIC, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the new collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

The NSIIC was initially authorized under the Consolidated Farm and Rural Development Act (Act). The Act, as amended, was passed as part of the 1996 Farm Bill (Pub. L. 104-127). The initial legislation included a provision that privatized the NSIIC 10 years after its ratification or once the full appropriation of $50 million was disbursed. Subsequently, the NSIIC was privatized on September 30, 2006 (72 FR 28945).

In 2008, the NSIIC was re-established under Title XI of the Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246), also known as the 2008 Farm Bill. Section 11009 of the 2008 Farm Bill repealed the requirement in section 375(e)(6) of the Act to privatize the NSIIC. Additionally, the 2008 Farm Bill provided for $1,000,000 in mandatory funding for fiscal year 2008 from the Commodity Credit Corporation for the NSIIC to remain available until expended, as well as authorization for appropriations in the amount of $10 million for each of fiscal years 2008 through 2012.

The authorizing legislation established in the United States Department of the Treasury (Treasury) the NIISC Revolving Fund (Fund). The Fund is to be available to the NSIIC, without fiscal year limitation, to carry out the authorized programs and activities of the NSIIC. The law provides authority for amounts in the Fund to be used for direct loans, loan guarantees, cooperative agreements, equity interests, investments, repayable grants, and grants to eligible entities, either directly or through an intermediary, in accordance with a strategic plan submitted by the NSIIC to the Secretary. This rulemaking will establish the NSIIC and use of the Fund for making only grants to eligible entities.

The purpose of the NSIIC is to: (1) Promote strategic development activities and collaborative efforts by private and State entities to maximize the impact of Federal assistance to strengthen and enhance production and marketing of sheep or goat products in the United States; (2) Optimize the use of available human capital and resources within the sheep or goat industries; (3) Provide assistance to meet the needs of the sheep or goat industry for infrastructure development, business development, production, resource development, and market and environmental research; (4) Advance activities that empower and build the capacity of the U.S. sheep or goat industry to design unique responses to the special needs of the sheep or goat industries on both a regional and national basis; and (5) Adopt flexible and innovative approaches to solving the long-term needs of the United States sheep or goat industry.

The management of the NSIIC is vested in a Board that is appointed by the Secretary. The Secretary reviews and monitors compliance of the Board as provided under the Act and rules and regulations. The Board is composed of seven voting members, of whom four would be active producers of sheep or goats in the United States, two would have expertise in finance and management, and one would have expertise in lamb, wool, goat, or goat product marketing. The Board would also include two non-voting members, the Under Secretary of Agriculture for Rural Development (RD) and the Under Secretary of Agriculture for Research, Education, and Economics. The Secretary would appoint the voting members from nominations submitted by eligible organizations. A member's term of office shall be 3 years with a maximum of two terms. Board members shall initially serve staggered terms of 1, 2, or 3 years, as determined by the Secretary. Only national organizations that (1) consist primarily of active sheep or goat producers in the United States and (2) have the primary interest of sheep or goat production in the United States can make nominations to the Board. USDA will announce in a nationwide press release that USDA is accepting nominations from the aforementioned national organizations.

The Board will meet not less than once each fiscal year. Board members will not receive compensation for serving on the Board, but will be reimbursed for travel, subsistence, and other necessary expenses. The Board shall be responsible for general supervision of the NSIIC; review of any contract and grant to be made or entered into by the NSIIC and any financial assistance provided to the NSIIC; making final decision—by majority vote—on whether or not to provide grants to an eligible entity; and developing and establishing a budget plan and long-term operating plan to carry out the goals of the NSIIC.

The authorizing legislation establishes in the Treasury, the NSIIC Fund. The Fund is to be available to the NSIIC, without fiscal year limitation, to carry out the authorized programs and activities of the NSIIC. The law provides authority for amounts in the Fund to be used to carry out authorized program activities of the NSIIC.

This interim rule authorizes a grant only program to be administered by the NSIIC Board. Based on funding, the Board will periodically announce that proposals may be submitted to the Board for consideration from eligible entities. The Board would determine how funds would be allocated. Proposals submitted to the Board must be consistent with the purpose of the NSIIC, which are to: (1) Promote strategic development activities and collaborative efforts by private and State entities to maximize the impact of Federal assistance to strengthen and enhance the production and marketing of sheep or goat products in the United States; (2) Optimize the use of available human capital and resources within the sheep or goat industries; (3) Provide assistance to meet the needs of the sheep or goat industry for infrastructure development, business development, production, resource development, and market and environmental research; (4) Advance activities that empower and build the capacity of the U.S. sheep or goat industry to design unique responses to the special needs of the sheep or goat industries on both a regional and national basis; and (5) Adopt flexible and innovative approaches to solving the long-term needs of the United States sheep or goat industry.

Sections 63.1 through 63.13 define certain terms pertinent to nomination processes for establishment of a NSIIC Board.

Sections 63.100 through 63.112 include provisions relating to the Board. These provisions cover establishment and membership, certification of organizations, the nomination process, powers and duties of the Board and other pertinent information related to Board function and operation.

Section 63.200 details the establishment and purpose of the NSIIC.

Sections 63.300 through 63.301 detail the establishment and use of the Fund. Specifically, these sections detail the purposes for which the Board shall expend funds and how the Fund shall be managed. This interim rule permits the making of contracts and grants only.

Sections 63.400 through 63.402 pertain to the books and records of the Board and the NSIIC, which the Secretary has access to and outlines the responsibilities for confidentiality.

Sections 63.500 through 63.505 contain miscellaneous provisions necessary for the function of the NSIIC and the oversight of USDA.

Pursuant to 5 U.S.C. 553, it is found and determined upon good cause that it is impracticable and contrary to the public interest to give preliminary notice prior to putting this rule into effect in order to establish the Board and the NSIIC program at the earliest possible date consistent with the 2008 Farm Bill.

This rule is issued under Marketing Order No. 920, as amended (7 CFR part 920), regulating the handling of kiwifruit grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

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

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule revises the administrative rules and regulations contained in the order. The change will bring the regulations into conformance with recent amendments to the order removing language that is inconsistent with the amended order. The amendments and this change to the order's administrative rules and regulations were recommended by the committee and were submitted to USDA on August 15, 2008.

Section 920.12 of the order defines the boundaries of the grower districts into which the production area is divided. Section 920.31(l) authorizes the committee to redefine the district boundaries, with the approval of the Secretary, as appropriate to reflect shifts of kiwifruit production within the production area. Section 920.131 was added to the order's rules and regulations in 1995 (60 FR 7432; February 8, 1995) to specify updated district boundaries that reflected industry production trends at that time.

California kiwifruit growers recently voted to amend the order by redefining the districts into which the production area is divided. Section § 920.12, which previously provided for eight grower districts, will be amended effective August 1, 2010 (75 FR 37288; June 29, 2010). The amendment to § 920.12 provides that the California production area will be divided into three grower districts: District 1, to include Butte, Sutter, and Yuba Counties; District 2, to include Tulare County; and District 3, to include all other California counties not included in Districts 1 and 2. At that time, § 920.131, which specifies the boundaries for eight grower districts, will be inconsistent with the amended § 920.12. For this reason, this rule removes § 920.131 from the order's rules and regulations, effective August 1, 2010.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions so that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

Small agricultural service firms, which include handlers regulated under the order, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000. Small agricultural growers have been defined as those with annual receipts of less than $750,000.

There are approximately 30 handlers of kiwifruit subject to regulation under the order and approximately 220 growers of kiwifruit in the regulated area. Information provided by the committee indicates that the majority of California kiwifruit handlers and growers would be considered small entities according to the SBA's definition.

The order regulates the handling of kiwifruit grown in the state of California. At the time the order was promulgated, kiwifruit acreage was more widespread throughout California and there were many more growers involved in kiwifruit production. The order originally provided for eight grower districts within the production area, with one membership seat apportioned to each district, and an additional seat reallocated annually to each of the three districts with the highest production in the preceding year. The structure was designed to afford equitable representation for all districts on the committee.

Planted acreage has been gradually concentrated into two main regions in recent years. That, and the decline in the number of growers over time, prompted consolidation of the districts and reallocation of grower member seats through the formal rulemaking process. Under the amended order, the production area will be divided into three grower districts, and committee membership will be allocated proportionately among the districts based upon the previous five years' average production for each district. These changes are expected to better reflect the current composition of the industry.

This rule removes § 920.131 from the order's administrative rules and regulations, effective August 1, 2010. The section specifies the boundaries for eight grower districts. As such, it will be inconsistent with the amended § 920.12, which provides the boundaries for three grower districts.

The changes in this interim rule are necessary to conform with amendments to the order, which will become effective on August 1, 2010. No alternatives to this action are deemed appropriate.

Regarding the impact of this action on the affected entities, both large and small entities are expected to benefit from the change. The revision in this interim rule provides consistency between the amended marketing order and its administrative rules and regulations. The order amendment is expected to ensure that the interests of all large and small entities are represented appropriately during committee deliberations.

Committee meetings in which regulatory recommendations and other decisions are made are open to the public. All members are able to participate in committee deliberations, and each committee member has an equal vote. Others in attendance at meetings are also allowed to express their views.

At committee meetings held on January 30, 2008, April 22, 2008, and July 9, 2008, the committee voted unanimously to recommend amending the order by revising the grower districts into which the production area is divided. The committee's recommendations were submitted to AMS on August 15, 2008. Growers approved the amendment to redefine district boundaries in a referendum held in March 2010. The amendment will become effective August 1, 2010.

This rule will not impose any additional reporting or recordkeeping requirements on large or small kiwifruit handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at the following Web site: http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

This rule invites comments on changes to the administrative rules and regulations currently prescribed under the marketing order for California kiwifruit. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the committee's recommendations and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect, and that good cause exists for effectuating this rule on August 1, 2010, because: (1) August 1, 2010 is the beginning of the fiscal period and amendments to the order's district boundary provision will become effective on that date; (2) this action is necessary to make the order's administrative rules and regulations consistent with the amended order; and (3) this rule provides a 60-day comment period, and any written comments received will be considered prior to any finalization of this rule.

This rule is issued under Marketing Agreement and Order No. 924 (7 CFR part 924), regulating the handling of fresh prunes grown in designated counties in Washington and in Umatilla County, Oregon, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Washington-Oregon fresh prune handlers are subject to assessments. Funds to administer the order are derived from such assessments. For the 2009-2010 fiscal period, an assessment rate of $2.00 per ton of fresh prunes handled was approved by USDA, to continue in effect indefinitely unless modified, suspended, or terminated. This action suspends the reporting requirements and the assessment rate for the 2010-2011 fiscal period, which began April 1, 2010, both remaining suspended until reinstated or permanently terminated.

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

The Committee meets regularly to consider recommendations for modification, suspension, or termination of the Washington-Oregon fresh prune order's regulatory requirements, which have been issued on a continuing basis. Committee meetings are open to the public and interested persons may express their views at these meetings. The USDA reviews Committee recommendations, including information provided by the Committee and from other available sources, and determines whether modification, suspension, or termination of the regulatory requirements would tend to effectuate the declared policy of the Act.

This rule suspends § 924.236, which established an assessment rate of $2.00 per ton on or after April 1, 2009, and § 924.160, which implements assessment reporting requirements. On June 1, 2010, the Committee unanimously voted in favor of requesting that USDA terminate the order, and included a recommendation that the reporting and assessment requirements—the only regulatory activities still in effect at this time—be suspended while termination of the order is being processed by USDA under a separate regulatory action.

Section 924.41 of the order provides authority for the Committee to assess handlers for their pro rata share of the expenses authorized each fiscal period. Section 924.60 of the order authorizes the Committee to collect reports and other information as necessary for the Committee to perform its duties under the order. Section 924.236 implements the continuing assessment rate, while § 924.160 implements the requirement that handlers report specified information to the Committee prior to October 30 of each year. This report is used as a basis for the Committee's collection of assessments from handlers.

Marketing Order No. 924 has been in effect since 1960 and has provided the fresh prune industry in Washington and Oregon with authority for grade, size, quality, maturity, pack, and container regulations, as well as authority for inspection requirements. The order also authorizes production research and marketing research and development projects, as well as the necessary reporting and recordkeeping functions required for operation. Based on the Committee's recommendation, USDA suspended the order's handling regulations in May 2006. These handling regulations required that certain varieties of fresh prunes be inspected to ensure that they met minimum grade standards. The Committee believed that the costs of inspection outweighed the benefits provided from having the regulatory requirements in effect.

Following the regulatory suspension, the Committee continued to collect assessments in order to maintain its functionality. The Committee felt that it should continue to fund its full operational capability in order to gauge the merits of the handling regulation suspension. Therefore, when it recommended suspension of the handling regulations, the Committee also recommended the establishment of reporting requirements for the purpose of tracking shipments and collecting assessments. Prior to the handling regulation suspension, the Committee relied on the Federal-State Inspection Service to provide it with copies of the certificates that accompany each lot of inspected fresh prunes. The inspection certificates contained information necessary for the Committee to collect assessments from each of the regulated handlers. On May 10, 2006, a new section 924.160 and Committee form “Handler Statement for Washington-Oregon Fresh Prunes” were implemented pursuant to publication in the Federal Register (71 FR 26817). The Committee used this form to collect fresh prune shipment information and to monitor market and crop conditions, thus helping it to make a determination regarding the impact of non-regulation on the industry.

The Washington-Oregon fresh prune industry has been in decline for many years, with acreage and production trending downward. This contributed to the suspension of the handling regulations in 2006. Since the handling regulations were suspended, the Committee has taken the opportunity to evaluate the suspension's effect on the marketing of fresh prunes over the past four years. Based on its analysis, the Committee has determined that the regulatory suspension has not negatively impacted the marketing of fresh prunes. Thus, the Committee determined that there is no longer a need for the order, and recommended its termination at a meeting held in Prosser, Washington, on June 1, 2010.

In addition, the Committee determined that there is no need to continue collecting assessments and requiring reports for the sole purpose of maintaining its functionality, thus recommended that the assessment rate and reporting requirements be immediately suspended. This action will relieve the industry of the assessment and reporting burden during the pendency of the termination process.

The Committee recommended a budget of $6,085 for the remainder of the period leading to order termination. The budgeted amount was established on the basis of the amount remaining in the Committee's monetary reserve. The budget in its entirety will provide for such operating expenses as are necessary during the termination process.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are six handlers of Washington-Oregon fresh prunes subject to regulation under the order and approximately 56 fresh prune producers in the regulated area. Small agricultural service firms are defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000.

Based on information compiled by both the Committee and the National Agricultural Statistics Service, the average producer price for fresh prunes was approximately $385 per ton. With 4,260 tons of fresh prunes shipped from the Washington and Oregon productions areas in 2009, this equates to average producer revenue of about $30,000. In addition, AMS Market News Service reported that 2009 f.o.b. prices ranged from $12.00 to $18.00 per 30-pound container, thus the entire Washington-Oregon fresh prune industry handled less than $7,000,000 worth of prunes last season. In view of the foregoing, the majority of Washington-Oregon fresh prune producers and handlers may be classified as small entities.

This rule suspends the reporting requirements regarding the collection of information pertaining to shipments and assessments under the order. It also suspends the assessment rate of $2.00 per ton established for the period beginning April 1, 2009, and continuing until modified, suspended, or terminated by USDA. The Committee recommended a budget of expenditures of $6,085 for the period beginning on April 1, 2010, and ending with termination of the order. This budget is based on the Committee's monetary reserve balance on April 1, 2010. Major expenses for the budget period beginning on April 1, 2010, are for Committee travel, the financial review, and management compensation.

The Committee made the recommendation to suspend the reporting and assessment requirements as an adjunct to the recommendation to terminate the order. As such, the only other alternative would have been to continue to assess handlers and to require reports, options not considered practicable since additional funds are not required.

This action suspends the reporting and assessment obligations imposed on handlers. During any period when effective, assessments are applied uniformly on all handlers and some of the costs may be passed on to producers. This suspension of the reporting and assessment requirements reduces the burden on handlers and should also reduce the burden on producers.

This rule will not impose any additional reporting or recordkeeping requirements on either small or large prune handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

The Committee's meeting was widely publicized throughout the Washington-Oregon fresh prune industry and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the June 1, 2010, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. Additionally, interested persons are invited to submit comments on this interim final rule, including the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

This rule invites comments on the suspension of the reporting and assessment requirements prescribed under the Washington-Oregon fresh prune marketing order. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that this interim final rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) The Committee has recommended prompt termination of the marketing order regulating the handling of Washington-Oregon fresh prunes and no longer requires reports or assessment income; (2) this action is a relaxation in the order's regulatory requirements; (3) the Committee unanimously recommended these changes at a public meeting and interested parties had an opportunity to provide input; and (4) this rule provides a 60-day comment period and any comments received will be considered prior to finalization of this rule.

This rule is issued under Marketing Order No. 946, as amended (7 CFR part 946), regulating the handling of Irish potatoes grown in Washington, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

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

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule suspends the order's handling regulation for russet potato varieties for the 2010-2011 season. This rule allows the Washington potato industry to market russet potatoes without regard to the minimum quality, maturity, pack, marking, and inspection requirements currently prescribed under the Washington potato marketing order. It is intended that the suspension will apply to the season beginning on July 1, 2010, and continuing through June 30, 2011. The minimum quality, maturity, pack, marking, and inspection requirements will resume July 1, 2011, for the 2011-2012 season and continue unless modified, suspended, or terminated.

This rule also establishes a new reporting requirement for russet potatoes handled during the same 12 month period. As assessments will remain in effect on all fresh russet potatoes handled under the order, reporting requirements will allow the Committee to obtain information necessary to facilitate assessment collection.

Section 946.52 of the order authorizes the establishment of grade, size, quality, or maturity regulations for any variety or varieties of potatoes grown in the production area. Section 946.52 also authorizes regulation of the size, capacity, weight, dimensions, pack, and marking or labeling of the container, or containers, which may be used in the packing or handling of potatoes, or both. Section 946.51 further authorizes the modification, suspension, or termination of regulations issued under § 946.52. Section 946.60 provides that whenever potatoes are regulated pursuant to § 946.52 such potatoes must be inspected by the Federal State Inspection Program (FSIP), and certified as meeting the applicable requirements of such regulations.

Section 946.70 authorizes the Committee, with the approval of USDA, to require information from handlers that will enable the Committee to exercise its duties under the order.

Section 946.336 of the order's administrative rules and regulations prescribes the grade, size, quality, cleanness, maturity, pack, marking, and inspection requirements for fresh market Washington potatoes.

The Committee meets regularly to consider recommendations for modification, suspension, or termination of the regulatory requirements for Washington potatoes which have been issued on a continuing basis. Committee meetings are open to the public and interested persons may express their views at these meetings. The USDA reviews Committee recommendations, information submitted by the Committee, and other available information, and determines whether modification, suspension, or termination of the regulatory requirements would tend to effectuate the declared policy of the Act.

At its January 26, 2010, meeting, the Committee was asked to evaluate the benefits of handling regulations and mandatory inspection for Washington potatoes. As a consequence, the Committee formed a subcommittee that met on May 11, 2010, to consider the implications of regulatory and inspection requirement suspension. Subsequently, at its June 1, 2010, meeting, the Committee unanimously recommended suspending the handling regulation for russet potatoes for the period beginning July 1, 2010, and ending on June 30, 2011, as well as establishing a requirement that handlers report their russet potato shipments during this period to the Committee on a specially developed form.

Historically, an objective of the order's handling regulations has been to ensure that quality Washington potatoes enter the fresh market, thereby ensuring consumer satisfaction, increased sales, and improved returns to producers. While the industry continues to support quality as an important factor in maintaining sales, the Committee believes the cost of inspection (mandated when the handling regulations are in effect) may exceed the benefits derived from the russet potato quality regulations.

With russet potato prices reportedly at low levels in recent years, the Committee, as noted earlier, has been studying the possibility of reducing costs through the elimination of mandatory inspection. In evaluating the relative benefits of quality control versus a regulation-free market, some concern was expressed at the meeting that elimination of the quality requirements could result in low quality potatoes being shipped to the fresh market, thereby negatively affecting consumer demand. Also, there is some concern that overall quality of the product may decline, and that the Washington potato industry could lose russet potato sales to production areas that are covered by quality and inspection requirements. Furthermore, because russet potatoes comprise about 76 percent of the fresh market Washington potato crop, the Committee is concerned about future availability of inspection services if the FSIP reduced staff as a result of the decrease in the demand for their services. With these concerns in mind, and having the desire to explore the benefits of non-regulation, the Committee recommended that the suspension of the russet potato handling regulation be effective for a temporary period only. This will enable the Committee to study the impacts of the suspension and consider appropriate actions for ensuing seasons.

This rule permits handlers to ship russet potatoes without regard to minimum quality, maturity, pack, marking, and inspection requirements for the period July 1, 2010, through June 30, 2011. Although this rule provides russet potato handlers the opportunity to decrease their total costs by elimination of the expenses associated with mandatory inspection, it does not restrict handlers from seeking inspection on a voluntary basis. The Committee will evaluate the temporary regulatory suspension at its next meeting.

This action will result in the elimination of the monthly FSIP inspection report for russet potatoes. The Committee uses these monthly reports—compiled by the FSIP from inspection certificates—as a basis for assessment collection. During the suspension of the regulations for russet potatoes, the Committee will require handler reports specific to russet potato shipments in order to collect assessments and to compile statistics.

Therefore, a new § 946.143 Assessment reports is added to the administrative rules and regulations requiring each person handling russet type potatoes to submit a monthly report to the Committee containing the following information: (a) The name and address of the handler; (b) the date and quantity of russet potatoes shipped; (c) the assessment payment due; and (d) other information as may be requested by the Committee. The first report shall include all required information from the effective date of this rule through the end of the month in which the assessment report information is approved by the Office of Management and Budget.

Authorization to assess handlers enables the Committee to incur expenses that are reasonable and necessary to administer the program. This reporting requirement will enable the Committee to continue collecting the funds needed to cover necessary program costs. Although adding reporting requirements, this rule, through the suspension of the handling regulation and thereby inspection, is expected to reduce overall industry expenses.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are 45 handlers of Washington potatoes subject to regulation under the order (inclusive of the 33 russet potato handlers) and approximately 267 producers in the regulated production area. Small agricultural service firms are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $7,000,000, and small agricultural producers are defined as those having annual receipts of less than $750,000.

During the 2008-2009 marketing year, the Committee reports that 10,279,734 hundredweight of Washington potatoes were shipped into the fresh market. Based on the USDA Economic Research Service estimate that the 2008 average f.o.b. price for fresh domestic potatoes was $8.42 per hundredweight, the average gross returns for each of the 45 handlers was less than $2,000,000.

In addition, based on information provided by the National Agricultural Statistics Service, the average producer price for Washington potatoes for 2009 was $7.10 per hundredweight. The average gross annual producer revenue for each of the 267 Washington potato producers is therefore calculated to be approximately $273,356. In view of the foregoing, the majority of Washington potato producers and handlers may be classified as small entities.

This rule suspends the handling regulation and establishes reporting requirements for russet type potatoes for the period beginning July 1, 2010, and ending June 30, 2011. This change is expected to reduce overall industry expenses while providing the industry with the opportunity to explore alternative marketing strategies.

The authority for regulation is provided in § 946.52 of the order, while authority for reports and records is provided in § 946.70. In addition, the handling regulation is specified under § 946.336 of the order's administrative rules and regulations.

The Committee anticipates that this rule will not negatively impact small businesses. This rule will suspend minimum quality, maturity, pack, marking, and inspection requirements. Though inspections will not be mandated for russet potatoes handled under the order, handlers may at their discretion choose to have their potatoes inspected. Handlers are thus able to control costs—which are generally passed on to producers—based on the demands of their customers. The Committee reports that during the 2008-2009 season, the total cost of inspection—at $0.07 per hundredweight for the approximately 7,800,000 hundredweight of Washington russet potatoes shipped—was about $546,000. This is approximately $12,133 per handler.

The Committee discussed alternatives to this recommendation. Other than not recommending any changes to the regulations, the Committee considered temporarily suspending the handling regulation for all types of potatoes, not just russet type potatoes. However, the Committee believes that it is beneficial to the industry to maintain the handling regulation and inspection requirements for round type potatoes. The Committee reports that round type potatoes generally command premium prices. The Washington potato industry believes that the order's round potato quality regulations, in conjunction with mandatory inspections, are valuable marketing tools. Therefore, the Committee recommended suspending the handling regulation for russet potatoes only.

An alternative to establishing the reporting requirements would have been relieving handlers from paying assessments on shipments of russet potatoes. Approximately 76 percent of the fresh potato shipments in Washington are russet varieties (as opposed to round white and round red or long white type potatoes), thus the Committee determined that it would not be able to cover its cost of operation should shipments of russet potatoes not be assessed.

This rule establishes a monthly reporting requirement for russet potato handlers. The report will provide the Committee with information necessary to track shipments and collect assessments. While this rule establishes new reporting requirements for russet potato shipments, the suspension of the handling regulation for russet potatoes also eliminates the more frequent reporting requirements that were included under the safeguard requirements for russet potatoes shipped under the order's special purpose shipment exemptions (§ 946.336(d) and (e)). Under these paragraphs, handlers are required to provide detailed reports whenever they divert regulated potatoes for livestock feed, charity, seed, prepeeling, processing, grading and storing in specified counties in Oregon, and experimentation.

Therefore, any additional reporting or recordkeeping requirements on either small or large russet potato handlers are expected to be offset by the elimination of other reporting requirements currently in effect. In addition, the suspension of the handling regulation and inspection requirements for russet potatoes is expected to further reduce industry expenses.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

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

The Committee's meetings were widely publicized throughout the Washington potato industry and all interested persons were invited to participate in Committee deliberations. Like all committee meetings, the January 26, May 11, and June 1, 2010, meetings were public meetings, and all entities, both large and small, were able to express views on this issue. Further, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the additional burden has been merged into the information collection which is currently under review for renewal under OMB No. 0581-0178, Generic OMB Vegetable and Specialty Crops.

Title: Irish Potatoes Grown in Washington—Marketing Order No. 946.

OMB Number: 0581-0178.

Type of Request: Revision of a currently approved collection.

Abstract: The information collection requirements in this request are essential to carry out the intent of the Act, to provide the respondents the type of service they request, and to administer the Washington potato order, which has been operating since 1949.

On June 1, 2010, the Committee unanimously recommended suspending the order's handling regulation for russet variety potatoes for the period beginning July 1, 2010, and ending June 30, 2011. To ensure that the Committee obtains handler information that is necessary for operation of the order, the Committee also unanimously recommended establishing a new reporting requirement. Information will be reported on a new Committee form, Monthly Russet Fresh Potato Report, which will require handlers to report, on a monthly basis, the total quantity of russet potatoes handled during the season. The first report shall include all required information from the effective date of this rule through the end of the month in which the assessment report information is approved by the Office of Management and Budget.

The new report is needed by the Committee to compile information that is essential for the collection of handler assessments and to provide statistical information to the industry. The Committee previously used monthly reports from the FSIP to obtain this information; reports that will no longer be available due to the suspension of the russet potato handling regulation. This new report will help to ensure compliance with the order's provisions and assist the Committee and the USDA with oversight and planning.

The information collected will be used only by authorized representatives of USDA, including AMS, Fruit and Vegetable Programs regional and headquarters staff, and authorized Committee employees. Authorized Committee employees will be the primary users of the information and AMS the secondary user.

The request for approval of the new information collection under the order is as follows:

Monthly Russet Fresh Potato Report.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 5 minutes per response.

Respondents: Washington russet potato handlers.

Estimated Number of Respondents: 33.

Estimated Number of Responses per Respondent: 12.

Estimated Total Annual Burden on Respondents: 33 hours.

Comments: Comments are invited on: (1) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Comments should reference OMB No. 0581-NEW and the Washington potato order (Marketing Order No. 946), and be sent to USDA in care of the Docket Clerk at the previously mentioned address. All comments received will be available for public inspection during regular business hours at the same address.

All responses to this notice will be summarized and included in the request for OMB approval. All comments will become a matter of public record. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

This rule invites comments on a temporary change to the handling regulations and reporting requirements for russet potatoes under the Washington potato marketing order. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) Any changes resulting from this rule should be effective as soon as practicable because the Washington russet potato shipping season begins in July; (2) the Committee discussed and unanimously recommended these changes at a public meeting and all interested parties had an opportunity to provide input; (3) potato handlers are aware of this action and want to take advantage of relaxation of the handling regulations as soon as possible; and (4) this rule provides a 60-day comment period and any comments received will be considered prior to finalization of this rule.

This rule is issued under Marketing Agreement and Order No. 983, as amended (7 CFR part 983), regulating the handling of pistachios grown in California, Arizona, and New Mexico, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

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

The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.

This rule modifies the aflatoxin sampling and testing regulations currently prescribed under the order. It streamlines the aflatoxin sampling and testing procedures under the order's rules and regulations for pistachios to be shipped for domestic human consumption, while maintaining sufficient aflatoxin controls. It is expected to reduce handler operating costs by providing a uniform and consistent aflatoxin sampling and testing procedure for pistachios shipped to all market destinations. The Committee unanimously approved the recommended modifications at its meeting on April 6, 2010.

Section 983.50 of the pistachio marketing order provides authority for aflatoxin regulations that require pistachios to be sampled and tested for aflatoxin prior to being shipped for domestic human consumption.

Section 983.150 of the order's rules and regulations contains specific aflatoxin sampling and testing requirements and currently specifies that three test samples be drawn and prepared for all lots of inshell and shelled pistachios, regardless of lot size. The samples are then sent to USDA approved laboratories for analysis of aflatoxin content. Depending upon the analytical results of the first sample, up to two additional tests and averaging the results of all tests may be required to determine whether any lot may be certified as “negative” for aflatoxin. Handlers have the option to rework the lot prior to subsequent testing in order to meet the aflatoxin requirements.

When the order was promulgated in 2004, the aflatoxin sampling and testing regulations provided sufficient sampling and testing procedures for determining aflatoxin controls for pistachios shipped for domestic human consumption. These aflatoxin sampling and testing procedures allowed handlers to use similar operating procedures for both domestic and export shipments.

In March 2010, the European Commission (EC), the regulatory body of the European Union (EU), adopted a revised Codex Alimentarius Commission's (Codex) sampling plan as its regulation for the importation of tree nuts. Over the past few years, the percentage of U.S. pistachio crop being exported has increased significantly. Currently, more than 60 percent of the annual crop is exported, with slightly more than half of exports being shipped to the EU and requiring special testing and handling procedures. As a result, handlers face inconsistent operating procedures and increased operating costs as it has become necessary to use two different sampling and testing procedures: One for pistachios shipped for domestic human consumption and another for pistachios shipped to the EU.

In an effort to streamline operating procedures, while maintaining sufficient aflatoxin level controls, the Committee, at its April 6, 2010, meeting recommended decreasing the total weight of lot samples and increasing the weight of the test samples as specified in Table 1 for inshell pistachios and Table 2 for shelled pistachios under the order's administrative rules and regulations:

The Committee also recommended changing § 983.150 to specify that for pistachio lots of up to 4,400 pounds, one test sample will be created from a minimum number of incremental samples and analyzed. For lots exceeding 4,400 pounds, two test samples will be created from a minimum number of incremental samples and analyzed. If the aflatoxin level in the first sample is 10 parts per billion (ppb) or less, the lot may be certified “negative” for aflatoxin and may be shipped. If the aflatoxin level is 20 ppb or less, the handler may either rework the lot and draw new samples for analysis, or direct that the second sample be analyzed. If the averaged results of the two analyses are 15 ppb or less, the lot may be certified “negative” for aflatoxin and may be shipped. Any lots exceeding the specified aflatoxin levels fail, and must be reported to the Committee. Failing lots may be reworked or destroyed or disposed of as described in § 983.152.

Further, the Committee recommended removing unnecessary language from § 983.150(a). In addition, the Committee also recommended changing the term Chromatograph in § 983.150(d)(3) to correctly read as Chromatography.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.

There are approximately 29 handlers and 875 producers of pistachios in California, Arizona and New Mexico. Small business firms, which include handlers regulated under the order, have been defined by the Small Business Administration (SBA) (13 CFR 121.201) as those having annual receipts of less than $7,000,000. Small agricultural producers have been defined as those with annual receipts of less than $750,000.

Currently, about 72 percent of the California handlers ship less than $7,000,000 worth of pistachios on an annual basis and would therefore be considered small business firms under the SBA definition. Based on acreage, production, and grower prices reported by the Committee, the average annual revenue for small handlers is approximately $1,721,911. The industry has estimated that one of the Arizona handlers and all three New Mexico handlers would also be considered small businesses.

Data provided by the Committee regarding the size of the 2009 California crop indicates that approximately 630 California growers had 350,000 pounds or less of assessable dry weight of pistachios. Using the most recent grower price of $2.04 per pound for pistachios, it is estimated that 81 percent of California producers had receipts of approximately $714,000, which is less than $750,000, and thus would be considered small business according to the SBA definition. Although there is no official data available to date, as these states were recently added to the order and have not completed one full crop year for reporting purposes, the industry estimates that the majority of producers in Arizona and New Mexico would also be considered small businesses.

This rule modifies the aflatoxin sampling and testing regulations currently prescribed under the California, Arizona and New Mexico pistachio order. It streamlines the aflatoxin sampling and testing procedures under the order's rules and regulations for pistachios to be shipped for domestic human consumption while maintaining sufficient aflatoxin controls. It is expected to reduce handler operating costs by providing a uniform and consistent aflatoxin sampling and testing procedure for pistachios shipped to all market destinations.

The impact of this regulatory modification was discussed by the Committee at its April 6, 2010, meeting. It is anticipated that all producers and handlers will benefit from this action regardless of size and regardless of the market they ship into, as it streamlines handler operations and increases marketing flexibility. Reducing the number of required samples, the number of aflatoxin analyses, and the total weight of the lot samples, while increasing the weight of the test samples for each lot is expected to result in an estimated annual savings to the industry of approximately $18,000, including reductions of $900 for sampling, $1,400 for testing, $12,750 for labor, and $3,750 in shipping costs for those small handlers that do not do testing on site.

The Committee discussed alternatives to this action at their April 6, 2010, meeting, including continuing to operate under the current aflatoxin regulations. However, the Committee unanimously agreed that operating with the current multiple sampling and testing procedures based upon shipping destination would continue to be confusing to the industry and would continue to generate higher handler operating costs. The recommended modification is expected to eliminate any confusion with regard to operating procedures, streamline handling operations, and lower handler operating costs.

This action will not impose any additional reporting or recordkeeping requirements on either small or large pistachio handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.

AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.

In addition, USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this rule.

Further, the Committee's meeting was widely publicized throughout the pistachio industry and all interested persons were invited to attend the meeting and participate in Committee deliberations. Like all Committee meetings, the April 6, 2010, meeting was a public meeting and all entities, both large and small, were able to express their views on this issue. Finally, interested persons are invited to submit comments on this interim rule, including the regulatory and informational impacts of this action on small businesses.

A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at: http://www.ams.usda.gov/AMSv1.0/ams.fetchTemplateData.do?template=TemplateN&page=MarketingOrdersSmallBusinessGuide. Any questions about the compliance guide should be sent to Antoinette Carter at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

This rule invites comments on modifications to the aflatoxin regulations currently prescribed under the pistachio marketing order. Any comments received will be considered prior to finalization of this rule.

After consideration of all relevant material presented, including the Committee's recommendation, and other information, it is found that this interim rule, as hereinafter set forth, will tend to effectuate the declared policy of the Act.

Pursuant to 5 U.S.C. 553, it is also found and determined upon good cause that it is impracticable, unnecessary, and contrary to the public interest to give preliminary notice prior to putting this rule into effect and that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because: (1) These changes are necessary to provide consistency in handler operating procedures and to reduce handler operating costs; (2) handlers are aware of these changes, which were unanimously recommended by the Committee at a public meeting where interested parties had an opportunity to provide input; and (3) this rule provides a 60-day comment period, and any comments received will be considered prior to finalization of this rule.

Discussion

On November 2, 2009, we issued AD 2009-23-11, Amendment 39-16085 (74 FR 58195; November 12, 2009). That AD required actions intended to address an unsafe condition on the products listed above.

Since we issued AD 2009-23-11, Empresa Brasileira de Aeronáutica S.A. (EMBRAER) has issued service bulletin 500-27-0003, dated May 18, 2010. The service bulletin changes flap position 3 from 36 degrees to 26 degrees. The service bulletin also changes flap position 3 Vref airspeeds and landing distance correction factors. Consequently, accomplishing the service bulletin necessitates changes to the Abnormal Procedures section of the FAA-approved airplane flight manual (AFM). The AFM changes were not included as part of the service bulletin.

The AGÊNCIA NACIONAL DE AVIAÇÃO CIVIL—BRAZIL, which is the aviation authority for Brazil, has issued AD No.: 2009-10-01R2, dated July 28, 2010 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are issuing this AD because we evaluated all information provided by the State of Design Authority and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

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 have also required different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the AD. These requirements take precedence over those copied from the MCAI.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because the loss of airplane air data sensors heating may cause ice buildup on their surface. This condition may cause wrong pressure acquisitions, resulting in erroneous flight parameters indication to the flight crew. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2010-0733; Directorate Identifier 2010-CE-038-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this AD.

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

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

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

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

(1) Is not a “significant regulatory action” under Executive Order 12866;

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

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

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

Throughout this document, whenever “we”, “us”, or “our” is used, we mean the EPA.

EPA is approving revisions to the Texas SIP that pertain to regulations on reporting of emissions (emissions inventories) submitted by stationary sources of air pollutants and conformity of general Federal actions to SIPs. Revisions were adopted by the State of Texas on December 1, 1999, and submitted to EPA Region 6 on December 17, 1999. Additional revisions to the emissions inventory regulations were adopted on February 7, 2007, and submitted to EPA on February 26, 2007. Specifically we are approving:

• Revisions to 30 TAC 101.10 Emissions Inventory Requirements, submitted December 1999;

• Revisions to 30 TAC 101.30, Conformity of General Federal Actions to State Implementation Plans submitted December 1999; and

• The creation of Chapter 19, Electronic Reporting (30 TAC 19) submitted February 2007.

This approval does not address the revision of 30 TAC 101.1 (Definitions) and adding of 30 TAC 101.28 (Stringency Determination for Federal Operating Permits) which were submitted on December 17, 1999. The revisions to section 101.1 were later superceded by revisions adopted by Texas on September 26, 2001, and approved by EPA on November 14, 2001 (66 FR 57252). Because the December 17, 1999, revisions 101.1 were superceded by the 2001 submission which has already been approved, no action or review is needed here. EPA intends to take action on 30 TAC 101.28 at a later time. A more complete description of the revisions is available in the Technical Support Document (TSD) posted on www.regulations.gov.

We are approving the revisions pursuant to Section 110, part D of the CAA. The reporting of additional emissions and emissions-related data will help to achieve and continue to maintain the NAAQS in Texas. Regulated entities that submit emissions inventories will be allowed to do so electronically. Approving these revisions and the administrative changes to the general conformity rule will make the federal SIP consistent with the state's rules.

We are also making a ministerial correction to the table in 40 CFR 52.2270(c) to reflect the correct title of the EPA approved regulation in the Texas SIP. The ministerial correction applies to the table entry for Section 101.30, which should be titled “Conformity of General Federal Actions to State Implementation Plans”.

EPA is publishing this rule without prior proposal because we view this as a non-controversial amendment and anticipate no adverse comments. However, in the proposed rules section of this Federal Register publication, we are publishing a separate document that will serve as the proposal to approve the SIP revision if relevant adverse comments are received. This rule will be effective on September 21, 2010 without further notice unless we receive relevant adverse comment by August 23, 2010. If we receive relevant adverse comments, we will publish a timely withdrawal in the Federal Register informing the public that the rule will not take effect. We will address all public comments in a subsequent final rule based on the proposed rule. We will not institute a second comment period on this action. Any parties interested in commenting must do so now. Please note that if we receive adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, we may adopt as final those provisions of the rule that are not the subject of an adverse comment.

Section 110 of the CAA requires states to develop air pollution regulations and control strategies to ensure that air quality meets the national ambient air quality standards (NAAQS) established by EPA. NAAQS are established under section 109 of the CAA and currently address six criteria pollutants: Carbon monoxide (CO), nitrogen dioxide, ozone, lead (Pb), particulate matter (PM), and sulfur dioxide (SO2).

A SIP is a set of air pollution regulations, control strategies, other means or techniques, and technical analyses developed by the state, to ensure that the state meets the NAAQS. It is required by section 110 and other provisions of the CAA. A SIP protects air quality primarily by addressing air pollution at its point of origin. A SIP can be extensive, containing state regulations or other enforceable documents, and supporting information such as emissions inventories, monitoring networks, and modeling demonstrations. Each state must submit regulations and control strategies to EPA for approval and incorporation into the federally-enforceable SIP.

On December 17, 1999, the Governor of Texas submitted rules for inclusion into the SIP which amended regulations on emissions inventories submitted by stationary sources of air pollutants and conformity of general Federal actions to SIPs. The revisions to 30 TAC 101.10, emissions inventory requirements: (1) Allow the state to collect additional data related to emissions from stationary sources, (2) contain requirements for sources in regions that are in violation of a NAAQS to report typical daily emissions of carbon monoxide and ozone precursor gases during the winter and summer months, respectively, (3) delete a requirement to report allowable emissions in the emissions inventory report, (4) add a requirement for facilities to report actual emissions for the statewide annual inventory update if a change in operating conditions results in a change from the most recently submitted emissions data of at least 5 tons per year in total annual emissions of volatile organic compounds, NOX, CO, SO2, Pb, or PM, (5) require submission of calculations representative of emission producing processes where continuous emission monitoring system data is not available, and (6) remove obsolete language that referred to inventory requirements due in 1992 and 1993.

The revisions to the regulation on conformity of general federal actions to SIPs, (30 TAC 101.30), are non-substantive changes. Definitions in the regulation were moved to another part of the Texas Administrative Code (30 TAC 101.1, Definitions) or were deleted if they were already part of the Code.

On October 13, 2005 EPA published the final Cross Media Electronic Reporting Rule (CROMERR) in the Federal Register, (70 FR 59848). CROMERR establishes electronic reporting as an acceptable regulatory alternative to paper reporting and establishes requirements to assure that electronic documents are as legally dependable as their paper counterparts. Subpart D of the CROMERR requires states, tribal or local government agencies that receive or wish to receive electronic reports under their EPA-authorized programs to apply to EPA for a revision to those programs and get EPA's approval. On February 26, 2007 Texas submitted to EPA revisions to the emissions inventory reporting regulations. The revisions allow for electronic reporting of emissions consistent with CROMERR.

On October 14, 2008, the Texas Commission on Environmental Quality (TCEQ) submitted two applications to EPA for approval under CROMERR; one for their Net Discharge Monitoring Report (NetDMR) and the second, for the State of Texas Environmental Electronic Reporting System (STEERS) electronic document receiving systems for revision or modification of multiple authorized programs under 40 CFR parts 51, 60, 63, 70, 123, 142, 233-404, 271, 281, and 403. EPA approved the applications and published a Federal Register notice on April 27, 2009 (74 FR 19082) to allow electronic reporting for specific authorized programs under Title 40.

EPA has evaluated the state's submittals that pertain to (1) Reporting of emissions and emission-related data by stationary sources of air pollutants, (2) conformity of general Federal actions to SIPs, and (3) allowing electronic reporting into Texas' SIP, and have determined that they meet the applicable requirements of the CAA and EPA air quality regulations because they are consistent with EPA's requirements for emissions reporting, conformity, and electronic reporting. (For further information on our evaluation see the TSD for this action). This approval will make these revised regulations federally enforceable. Enforcement of the regulations in a state SIP before and after it is incorporated into the federally approved SIP is primarily a state responsibility. However, after the regulations are federally approved, we are authorized to take enforcement action against violators. Citizens are also offered legal recourse to address violations as described in Section 304 of the CAA. Approval will also help make the federally approved SIP consistent with state regulations.

For additional information on our evaluation please refer to the Technical Support Document found in the electronic docket.

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act 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 Clean Air Act. 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 Clean Air Act; 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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 21, 2010. 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. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On May 4, 2010 (75 FR 23640) the Environmental Protection Agency (EPA) proposed to conditionally approve New York's reasonably available control measure (RACM) analysis and New York's efforts to meet the reasonably available control technology (RACT) requirement. The reader is referred to that rulemaking action for a more detailed discussion of New York's RACT and RACM plans. EPA received no comments in response to the May 4, 2010 proposal. Therefore, in this action, EPA is conditionally approving New York's RACT and RACM plans.

On September 1, 2006, New York submitted its State-wide 8-hour ozone RACT SIP, which included a determination that many of the RACT rules currently contained in its SIP meet the RACT obligation for the 8-hour standard. On February 8, 2008, New York submitted two comprehensive 8-hour ozone SIPs—one for the New York portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT nonattainment area, entitled, “New York SIP for Ozone—Attainment Demonstration for New York Metro Area” and one for the Poughkeepsie nonattainment area, entitled, “New York SIP for Ozone—Attainment Demonstration for Poughkeepsie, NY Area.” The submittals included the 2002 base year emissions inventory, projection year emissions, attainment demonstrations, Reasonable Further Progress (RFP) plans, RACT analysis, RACM analysis, contingency measures, new source review and on-road motor vehicle emission budgets. These proposed SIP revisions were subject to notice and comment by the public and the State addressed the comments received on the proposed SIP revisions before adopting the plans and submitting them for EPA review and rulemaking action.

Included in New York's February 8, 2008 8-hour Ozone SIP submittal was a list of additional control measures identified by the State as RACT and RACM. The State committed to adopt additional control measures applicable to the following source categories: Adhesives and Sealants, Consumer Products, Portable Fuel Containers, Graphic Arts, Asphalt Formulation, Asphalt Paving Production, Portland Cement Plants, Glass Manufacturing, and NOx RACT.

Of the source categories identified by New York, the State adopted rules for Portable Fuel Containers on July 15, 2009, and for Consumer Products on September 30, 2009. New York submitted the Consumer Products rule (on October 21, 2009) and the Portable Fuel Container rule (on November 23, 2009) to EPA, for review and approval into the SIP. On May 28, 2010 (75 FR 29897), EPA approved New York's Consumer Products and Portable Fuel Container rules.

On April 15, 2010, New York submitted a letter committing to adopt the necessary control measures that will satisfy the RACT and RACM requirement by August 31, 2010, which is no more than one year from our final action on the RACT and RACM SIP submittals.

On August 25, 2009 (74 FR 42813), EPA proposed to disapprove New York's RACT and RACM plans. In that proposed rulemaking action, EPA made suggestions for how New York could correct the identified deficiencies and strengthen the 8-hour ozone SIP (see 74 FR 42819). As discussed in Section II, New York adopted and submitted for inclusion in the SIP two of the control measures it had adopted. On December 23, 2009, New York proposed adoption of all but one of the remaining additional control measures that it committed to adopt as satisfying the RACT and RACM requirement. On April 21, 2010, New York proposed adoption of that one remaining control measure. Based on this recent progress and on New York's April 15, 2010 letter committing to submit adopted RACT/RACM rules by August 31, 2010, EPA proposed a conditional approval of the RACT and RACM SIPs for the 8-hour ozone NAAQS on May 4, 2010. EPA has determined that New York should be able to meet this commitment because the State has already adopted rules for two of the source categories and proposed RACT/RACM provisions for all of the remaining source categories.

EPA is conditionally approving the moderate area RACM analysis for the New York portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT 8-hour ozone moderate nonattainment area as presented in the February 8, 2008 “New York SIP for Ozone—Attainment Demonstration for New York Metro Area” SIP submittal.

EPA is also conditionally approving the September 1, 2006 New York RACT analysis SIP submittal, supplemented on February 8, 2008 and September 16, 2008, which applies to the entire State and to the New York portion of the New York-Northern New Jersey-Long Island, NY-NJ-CT and the Poughkeepsie 8-hour ozone moderate nonattainment areas.

EPA is conditionally approving the RACT and RACM analyses for the 8-hour ozone NAAQS based on New York's letter committing to submit adopted RACT/RACM rules for several source categories by August 31, 2010. EPA has determined that New York should be able to meet this commitment because the State has already adopted rules for two of the source categories and proposed RACT/RACM provisions for all of the remaining source categories.

Under section 110(k)(4) of the Act, EPA may conditionally approve a plan based on a commitment from the State to adopt specific enforceable measures by a date certain, but not later than 1 year from the date of approval. If EPA conditionally approves the commitment in a final rulemaking action, the State must meet its commitment to adopt the identified regulations. If the State fails to do so, this action will become a disapproval upon the State's failure to meet its commitment. EPA will notify the State by letter that this action has occurred. If the conditional approval converts to a disapproval, the commitment will no longer be a part of the approved New York SIP. Upon notification to the State that the conditional approval has converted to a disapproval, EPA will publish a notice in the Federal Register notifying the public that the conditional approval automatically converted to a disapproval. If EPA disapproves the RACT and RACM SIP submittals, such action will start a sanctions and FIP clock (see section V). If the State meets its commitment, within the applicable time frame, the conditionally approved submission will remain a part of the SIP until EPA takes final action approving or disapproving the RACT and RACM submittals. If EPA approves the submittals, the RACT and RACM analyses will be fully approved into the SIP in their entirety.

The Act provides for the imposition of sanctions and the promulgation of a Federal Implementation Plan (FIP) if States fail to correct any deficiencies identified by EPA in a final disapproval action within certain timeframes.

If EPA disapproves a required SIP submittal or component of a SIP submittal, section 179(a) provides for the imposition of sanctions unless the deficiency is corrected within 18 months of the final rulemaking of disapproval. The first sanction would apply 18 months after EPA disapproves the SIP submittal if a State fails to make the required submittal. Under EPA's sanctions regulations, 40 CFR 52.31, the first sanction would be 2:1 offsets for sources subject to the new source review requirements under section 173 of the Act. If the State has still failed to submit a SIP for which EPA proposes full or conditional approval 6 months after the first sanction is imposed, the second sanction will apply. The second sanction is a limitation on the receipt of Federal highway funds. EPA also has authority under section 110(m) to sanction a broader area.

In addition to sanctions, if EPA finds that a State failed to submit the required SIP revision or disapproves the required SIP revision, or a portion thereof, EPA must promulgate a FIP no later than 2 years from the date of the finding if the deficiency has not been corrected.

This action is not a “significant regulatory action” under the terms of Executive Order (EO) 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under the EO.

This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., because this SIP conditional approval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new information collection burdens but simply conditionally approves certain State requirements for inclusion into the SIP. Burden is defined at 5 CFR 1320.3(b).

The Regulatory Flexibility Act (RFA) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements 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 not-for-profit enterprises, and small governmental jurisdictions. For purposes of assessing the impacts of today's rule on small entities, small entity is defined as: (1) A small business 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 final rule on small entities, I certify that this action will not have a significant impact on a substantial number of small entities. This rule does not impose any requirements or create impacts on small entities. This SIP conditional approval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new requirements but simply disapproves certain State requirements for inclusion into the SIP. Accordingly, it affords no opportunity for EPA to fashion for small entities less burdensome compliance or reporting requirements or timetables or exemptions from all or part of the rule. The fact that the Clean Air Act prescribes that various consequences (e.g., higher offset requirements) may or will flow from this conditional approval does not mean that EPA either can or must conduct a regulatory flexibility analysis for this action. Therefore, this action will not have a significant economic impact on a substantial number of small entities.

We continue to be interested in the potential impacts of this final rule on small entities and welcome comments on issues related to such impacts.

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. EPA has determined that the final conditional approval action does not include a Federal mandate that may result in estimated costs of $100 million or more to either State, local, or Tribal governments in the aggregate, or to the private sector. This action conditionally approves pre-existing requirements under State or local law, and imposes no new requirements. Accordingly, no additional costs to State, local, or Tribal governments, or to the private sector, result from this action.

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

This 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, because it merely conditionally approves certain State requirements for inclusion into the SIP and does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act. Thus, Executive Order 13132 does not apply to this action.

This action does not have Tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP EPA is conditionally approving would not 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. Thus, Executive Order 13175 does not apply to this action.

EPA interprets EO 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997). This SIP conditional approval under section 110 and subchapter I, part D of the Clean Air Act will not in-and-of itself create any new regulations but simply conditionally approves certain State requirements for inclusion into the SIP.

This final rule is not subject to Executive Order 13211 (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 Transfer and Advancement Act of 1995 (“NTTAA”), Public Law No. 104-113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.

The EPA believes this action is not subject to requirements of Section 12(d) of NTTAA because application of those requirements would be inconsistent with the Clean Air Act.

Executive Order (EO) 12898 (59 FR 7629 (Feb. 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 lacks the discretionary authority to address environmental justice in this final action. In reviewing SIP submissions, EPA's role is to approve or disapprove State choices, based on the criteria of the Clean Air Act. Accordingly, this action merely conditionally approves certain State requirements for inclusion into the SIP under section 110 and subchapter I, part D of the Clean Air Act and will not in-and-of itself create any new requirements. Accordingly, it 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.

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 Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 21, 2010. 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. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

On March 12, 2010, the State of Maryland requested a one-year attainment date extension for the Baltimore nonattainment area which is classified as moderate for the 1997 8-hour ozone NAAQS. The Baltimore nonattainment area consists of Anne Arundel, Baltimore, Carroll, Harford, and Howard Counties and Baltimore City. Since this area was classified as a moderate ozone nonattainment area, the statutory ozone attainment date, as prescribed by section 181(a) of the CAA, is June 15, 2010. The State of Maryland's request is that the attainment date be extended to June 15, 2011.

Section 172(a)(2)(C) of subpart 1 of the CAA provides for EPA to extend the attainment date for an area by one year if the State has complied with all the requirements and commitments pertaining to the area in the applicable implementation plan and no more than a minimal number of exceedances of the NAAQS has occurred in the attainment year. Up to two one-year extensions may be issued for a single nonattainment area. Section 181(a)(5) of subpart 2 contains a similar provision for the ozone NAAQS, but instead of providing for an extension where there has been a “minimal” number of exceedances, it allows an extension only if there is no more than one exceedance of the NAAQS in the year proceeding the extension year. However, the language in section 181(a)(5) reflects the form of the 1-hour ozone NAAQS and not the 1997 8-hour ozone NAAQS. 40 CFR 51.907 sets forth how sections 172(a)(2)(C) and 181(a)(5) apply to an area subject to the 1997 8-hour ozone NAAQS. Under 40 CFR 51.907, an area will meet the requirement of section 172(a)(2)(C)(ii) or 181(a)(5)(B) of the CAA pertaining to one-year extensions of the attainment date if:

(a) For the first one-year extension, the area's 4th highest daily 8-hour average in the attainment year is 0.084 parts per million (ppm) or less,

(b) For the second one-year extension, the area's 4th highest daily 8-hour value, averaged over both the original attainment year and the first extension year, is 0.084 ppm or less.

(c) For purposes of paragraphs (a) and (b) of this section, the area's 4th highest daily 8-hour average shall be from the monitor with the highest 4th highest daily 8-hour average of all the monitors that represent that area.

EPA's review of the actual ozone air quality data in the Air Quality System shows that the 4th highest daily average 8-hour ozone concentrations for the 2009 attainment year ozone season, for all monitors in the Baltimore moderate ozone nonattainment area are measured at 0.084 ppm or less (Table 1), as required by 40 CFR 51.907(a). The monitoring data has been quality controlled and quality assured.

EPA has determined that the requirements for a one-year extension of the attainment date have been fulfilled as follows:

(1) The State of Maryland has complied with all requirements and commitments pertaining to the area in the applicable ozone implementation plan; and

(2) The Baltimore nonattainment area's 4th highest daily 8-hour monitored value during the 2009 ozone season is 0.084 ppm or less.

Therefore, EPA approves Maryland's attainment date extension request for the Baltimore moderate ozone nonattainment area. As a result, the chart in 40 CFR 81.321 entitled “Maryland—Ozone (8-Hour Standard)” is being modified to reflect EPA's approval of Maryland's attainment date extension request.

EPA is approving the attainment date extension from June 15, 2010 to June 15, 2011 for the Baltimore nonattainment area, which is classified as moderate for the 1997 8-hour ozone NAAQS. 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 September 21, 2010 without further notice unless EPA receives adverse comment by August 23, 2010. 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 Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355 (May 22, 2001)). This action merely finds that an area has qualified for a one-year extension of the attainment date of a previously established NAAQS, and imposes no additional requirements. Accordingly, the Administrator certifies that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because this rule does not impose any additional enforceable duties, it 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). This rule also does not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal Government and Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it merely determines that each of two areas has attained a Federal standard, and does not alter the relationship or the distribution of power and responsibilities established in the CAA. This rule also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant.

This rule does not involve establishment of technical standards, and thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. As required by section 3 of Executive Order 12988 (61 FR 4729, February 7, 1996), in issuing this rule, EPA has taken the necessary steps to eliminate drafting errors and ambiguity, minimize potential litigation, and provide a clear legal standard for affected conduct. EPA has complied with Executive Order 12630 (53 FR 8859, March 15, 1988) by examining the takings implications of the rule in accordance with the “Attorney General's Supplemental Guidelines for the Evaluation of Risk and Avoidance of Unanticipated Takings” issued under the executive order.

Executive Order (EO) 12898 (59 FR 7629 (Feb. 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 it does not affect the level of protection provided to human health or the environment. The rulemaking does not affect the level of protection provided to human health or the environment because extending the attainment date does not alter the emission reduction measures that are required to be implemented in the Baltimore Area, which is classified as moderate nonattainment for the 1997 8-hour ozone standard. See 69 FR at 23909 (April 30 2004). Additionally, if the Baltimore Area were not granted an extension of its attainment date, EPA's recourse would be to initiate a reclassification of the Baltimore Area from its current classification of moderate nonattainment to serious nonattainment, pursuant to section 181(b)(2) of the CAA. Because the Baltimore area was formerly a severe nonattainment area under the revoked 1-hour ozone standard (see, 56 FR at 56773, November 6, 1991), it is required to continue to implement severe area requirements pursuant to EPA's interpretation of “anti-backsliding” provision of section 172(e) of the CAA. See 69 FR at 23973, April 30, 2004, South Coast Air Quality Management District v. EPA, 472 F.3d 882 (DC Cir. 2006), modified and rehearing den., 489 F.3d 1245 (DC Cir. 2007). The severe area requirements are more stringent than both the moderate and serious area requirements set forth in Title I, Part D, Subpart 2 of the CAA. Therefore, even if EPA were to not grant the attainment date extension and instead move to reclassify the area to serious nonttainment, no additional emission reduction measures would be required to implemented in the Baltimore area through a 181(b)(2) reclassification.

The extension of the attainment deadline for the 1997 8-hour ozone NAAQS does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

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(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0407 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 September 21, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2009-0407 by one of the following methods:

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

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

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

In the Federal Register of July 22, 2009 (74 FR 36200) (FRL-8425-8), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 7E7188) by IR-4, Rutgers University, 500 College Road, East, Suite 201W, Princeton, NJ 08540 (on behalf of Sellew and Associates, LLC, 84 Shadybrook Lane, Carlisle, MA 01741). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Trichoderma hamatum isolate 382. This notice referenced a summary of the petition prepared by the petitioner, IR-4 (on behalf of Sellew and Associates, LLC), which is available in the docket, http://www.regulations.gov. A comment was received on the notice of filing. EPA's response to this comment is discussed in Unit VII.C.

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

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

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

Trichoderma hamatum isolate 382 is a naturally occurring fungus that is found widely in soils, potting media, corn grits, and flour, as well as on root surfaces of various plants, decaying bark, fruits, and vegetables. Indeed, Trichoderma hamatum populations have been measured at levels between 1 x 104 and 1 x 108 colony-forming units (cfu) per gram dry weight of container media alone. As a pesticidal active ingredient, Trichoderma hamatum isolate 382 will be mixed with or applied to soilless potting media or compost mainly to induce systemic resistance to diseases of roots and aboveground plant parts. It may also suppress the activity of certain soilborne plant pathogens (including Pythium species, Phytophthora species, Fusarium species, Rhizoctonia solani, Sclerotium rolfsii, and Thielaviopsis basicola) and protect the foliage of some plant species from powdery mildew, Botrytis blight, Phytophthora blights, and dieback diseases (e.g., Botryosphaeria dieback) through competition for nutrients and space. No relationships are known between the Trichoderma genus and any pathogen of humans, animals, or plants. Most notably, Trichoderma hamatum isolate 382 is not considered a dermatophyte fungus in that it is not classified into any of the three genera (Microsporum, Epidermophyton, and Trichophyton) known to cause skin disease in animals and humans.

In conjunction with Experimental Use Permit 69006-EUP-1, which was effective from January 1, 1996 until January 1, 1998, a temporary exemption from the requirement of a tolerance was established previously for Trichoderma hamatum isolate 382 for use on selected ornamentals and vegetable bedding plants in or on the raw agricultural commodities broccoli, cabbage, cauliflower, cucumber, eggplant, lettuce, cantaloupe, pepper, tomato, and watermelon (61 FR 28580, June 5, 1996, FRL-5371-2). This temporary exemption expired on March 1, 1998. Although there are no currently existing tolerances or tolerance exemptions for Trichoderma hamatum species, there are permanent tolerance exemptions established for all food commodities for two strains of a closely related Trichoderma species: Trichoderma harzianum KRL-AG2 (ATCC #20847) strain T-22 under 40 CFR 180.1102 (64 FR 16856, April 7, 1999 FRL-6070-3) and Trichoderma harzianum strain T-39 under 40 CFR 180.1201 (65 FR 38753, June 22, 2000, FRL-6383-7).

The petitioner submitted Tier I mammalian toxicology data for the active ingredient, Trichoderma hamatum isolate 382. EPA has reviewed and found these data acceptable to support the establishment of a permanent exemption from the requirement of a tolerance for residues of Trichoderma hamatum isolate 382. These studies indicate that the active ingredient is not toxic, infective, and/or pathogenic to rats when administered by the oral, pulmonary, or injection routes of exposure and is only slightly irritating to the skin. Furthermore, even with extensive experimental uses in the mid- to late-1990s and subsequent compilation of data to support potential pesticide products, no Trichoderma hamatum isolate 382-related hypersensitivity incidents have been reported to EPA. The overall conclusions from these data are described in Unit III.B., while more in-depth synopses of the study results can be found in the risk assessments and Biopesticides Registration Action Document provided as references in Unit III.C.

1. Acute oral toxicity and pathogenicity - rat (Harmonized Test Guideline 885.3050; Master Record Identification Number (MRID No.) 455836-03). An acceptable acute oral and pathogenicity study demonstrated that Trichoderma hamatum isolate 382 was not toxic, infective, and/or pathogenic to rats when dosed at up to 3.9 x 108 cfu/animal (U.S. EPA 2009, 2010b, 2010c).

2. Acute pulmonary toxicity and pathogenicity - rat (Harmonized Test Guideline 885.3150; MRID Nos. 460106-02 and 469997-01). An acceptable acute pulmonary toxicity and pathogenicity study demonstrated that Trichoderma hamatum isolate 382 was not toxic, infective, and/or pathogenic to rats when dosed intratracheally at 1.3 x 107 cfu/animal (U.S. EPA 2009, 2010b, 2010c).

3. Acute injection toxicity and pathogenicity - rat (Harmonized Test Guideline 885.3200; MRID No. 475989-08). An acceptable acute injection toxicity and pathogenicity study demonstrated that Trichoderma hamatum isolate 382 was not toxic, infective, and/or pathogenic in rats when dosed intraperitoneally at 4.0 x 107 cfu/animal (U.S. EPA 2009, 2010b, 2010c).

4. Hypersensitivity incidents (Harmonized Test Guideline 885.3400). No hypersensitivity incidents involving Trichoderma hamatum isolate 382 and occurring during fermentation, processing, formulation, or research have been reported to the Agency. Any future hypersensitivity incidents must be reported per 40 CFR 158.2140 (U.S. EPA 2010c).

5. Acute oral toxicity (Harmonized Test Guideline 870.1100; MRID No. 475989-04), acute dermal toxicity (Harmonized Test Guideline 870.1200; MRID No. 475989-04), and acute inhalation toxicity (Harmonized Test Guideline 870.1300; MRID No. 475989-04). The Agency waived these acute toxicity data requirements based on Trichoderma hamatum isolate 382's ubiquitous presence in the environment (see Unit III.A.) and the absence of incidents of hypersensitivity, allergies, or other adverse effects, despite varying uses of Trichoderma hamatum isolate 382 since 1996 (e.g., research activities performed in accordance with the terms of an experimental use permit) (U.S. EPA 2009, 2010c).

6. Primary dermal irritation - rabbit (Harmonized Test Guideline 870.2500; MRID 475989-05). An acceptable primary dermal irritation study demonstrated that Trichoderma hamatum isolate 382 was slightly irritating to the skin of rabbits. The study resulted in a classification of Toxicity Category IV for this strain of Trichoderma hamatum (U.S. EPA 2009, 2010a, 2010c).

1. U.S. EPA. 2009. Review of Product Chemistry, Manufacturing Process, and Acute Toxicity Studies of the End Use Product (EP) Floraguard (EPA Reg. No. 74205-G) Containing the Active Ingredient (AI) Trichoderma hamatum isolate 382 (0.9%). Memorandum from I. Barsoum, Ph.D. and J. Kough, Ph.D. to A. Sibold dated December 14, 2009 (available as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).

2. U.S. EPA. 2010a. Review of the Registrant's Response to the Deficiencies Found by the Agency in Its Review of Product Chemistry, Manufacturing Process, and Acute Toxicity Studies of the Product Trichoderma hamatum isolate 382 (EPA Reg. No. 74205-G). Memorandum from I. Barsoum, Ph.D. and J. Kough, Ph.D. to A. Sibold dated April 27, 2010 (available as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).

3. U.S. EPA. 2010b. Review of Information to Support a Food Tolerance Determination for Trichoderma hamatum isolate 382 (ATCC# 20765), the Active Ingredient in Floraguard Related to Tolerance Petition (7E7188). Memorandum from J. Kough, Ph.D. to A. Sibold dated May 18, 2010 (available as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).

4. U.S. EPA. 2010c. Trichoderma hamatum isolate 382 Biopesticides Registration Action Document dated June 1, 2010 (available as “Supporting & Related Materials” within Docket Number EPA-HQ-OPP-2010-0489 at http://www.regulations.gov).

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

Dietary exposure to the microbial pesticide may occur (more likely through food than drinking water), but the lack of acute oral toxicity, infectivity, and/or pathogenicity, based on a toxicology test on rats presented in Unit III.B., is just one of several factors supporting the establishment of a permanent exemption from the requirement of a tolerance for residues of Trichoderma hamatum isolate 382.

1. Food. Dietary exposure to the microbial active ingredient is expected to be minimal. Trichoderma hamatum isolate 382 is only intended for directed application to or incorporation into soilless potting media or compost. These application methods are not conducive to residue accumulation in crops. Moreover, Trichoderma species live in soils and are unlikely to persist on plants. Any spores that end up on plants due to application as a pesticide would decrease over time as a result of weathering, desiccation, and ultraviolet radiation, which can kill even quiescent forms of the fungus. In the remote likelihood that the applied fungus grew on the edible portions of treated crops, the results of the toxicology testing demonstrated that no toxicity, infectivity, and/or pathogenicity in treated animals occurred, even when dosed with high levels of Trichoderma hamatum isolate 382 by the oral route of exposure (see additional discussion in Unit III.B.).

2. Drinking water exposure. Drinking water exposure is expected to be negligible because the microbial fungicide will not be applied to water. Further, Trichoderma hamatum isolate 382 is a soil microorganism and would not proliferate in aquatic environments. Moreover, the Agency believes that Trichoderma species within the soil will not likely percolate into water due to the large size of the fungal spores and the fact that they adhere readily to soil particles. Even in the unlikely event that dietary exposure occurs through drinking water, the results of the oral toxicology testing, as described in Unit III.B., demonstrated that no toxicity, infectivity, and/or pathogenicity in treated animals occurred.

Trichoderma hamatum isolate 382 is a naturally occurring microorganism and is ubiquitous in the environment. As a pesticidal active ingredient, Trichoderma hamatum isolate 382 will be applied to or incorporated into soilless potting media or compost predominantly in greenhouses. Although some applications may take place in residential areas, there is no evidence of any concern for inhalation or dermal toxicity at exposure levels several orders of magnitude higher than would be expected to be encountered by a typical residential end user (see Unit III.B.). Additionally, as anticipated given that there are no recognized relationships between the Trichoderma genus and any pathogen of humans and animals, there have been no reports of adverse effects to humans from inhalation or dermal exposure to this widespread fungus.

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 Trichoderma hamatum isolate 382 to share a common mechanism of toxicity with any other substances, and Trichoderma hamatum isolate 382 does not appear to produce a toxic metabolite as its mode against the target pests. For the purposes of this tolerance exemption action, therefore, EPA has assumed that Trichoderma hamatum isolate 382 does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database unless EPA determines that a different margin of safety will be safe for infants and children. Margins of exposure (safety), which are often referred to as uncertainty factors, are incorporated into EPA risk assessments either directly or through the use of a margin of exposure analysis, or by using uncertainty (safety) factors in calculating a dose level that poses no appreciable risk.

Based on the acute toxicity and pathogenicity data discussed in Unit III.B., as well as the ubiquity of Trichoderma hamatum isolate 382 in the environment without reported adverse effects to humans, EPA concludes that there is a reasonable certainty that no harm will result to the United States population, including infants and children, from aggregate exposure to the residues of Trichoderma hamatum isolate 382. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. The Agency has arrived at this conclusion because the data and information available on Trichoderma hamatum isolate 382 do not demonstrate toxic, pathogenic, and/or infective potential to mammals. Thus, there are no threshold effects of concern and, as a result, an additional margin of safety is not necessary.

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. In this context, EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations 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 Trichoderma hamatum isolate 382.

One comment, which specifically stated that the petition should be rejected without full testing for 20 years, was received in response to the notice of filing. The Agency notes that the data requirements do not require 20 years of testing, and no current information available to EPA suggests the need for 20 years worth of data to characterize the pesticide's toxicity, infectivity and/or pathogenicity. For the proposed uses of the microbial active ingredient (i.e., applications to or incorporation into soilless potting media or compost), the Agency has concluded that there is a reasonable certainty that no harm will result to the United States population, including infants and children, from aggregate exposure to the residues of Trichoderma hamatum isolate 382. Thus, under the standard in FFDCA section 408(c)(2), an exemption from the requirement of a tolerance for residues of Trichoderma hamatum isolate 382 is appropriate.

The Agency concludes that there is a reasonable certainty that no harm will result to the United States population, including infants and children, from aggregate exposure to residues of Trichoderma hamatum isolate 382. Therefore, an exemption is established for residues of Trichoderma hamatum isolate 382 in or on all food commodities when applied as a fungicide and used in accordance with good agricultural practices.

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

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

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

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

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0138 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 September 21, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described in ADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2009-0138, 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 April 8, 2009 (74 FR 15971) (FRL-8407-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 8E7504) by Dow AgroSciences, LLC, 9330 Zionsville Rd, Indianapolis, IN, 46268. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of TIPA (CAS No. 122-20-3) when used as an inert ingredient for use as a neutralizer in pesticide formulations applied to growing crops and raw agricultural commodities pre- and post-harvest. That notice referenced a summary of the petition prepared by Dow AgroSciences, LLC, 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 section 408(c)(2)(B) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for TIPA including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with TIPA 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 TIPA 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.

TIPA has low acute toxicity via the oral and dermal routes. It is moderately irritating to the skin and severely irritating to the eye. It is not a skin sensitizer.

A subchronic study was available in the dog. Following subchronic exposure to TIPA to dogs via the diet, no treatment related effects were noted up to the highest dose tested (288 milligrams/kilograms/day (mg/kg/day)).

A developmental study was available for review (rat) on the surrogate chemical, diisopropanolamine (DIPA). In this study maternal and offspring toxicity were not observed at the highest dose tested (1,000 mg/kg/day).

In a 1-generation reproduction toxicity study in rats with TIPA, no adverse clinical, histological, or reproductive effects were observed at the highest dose tested (M/F: 609/700 mg/kg/day).

Three mutagenicity studies (Ames test, mammalian gene mutation, and chromosome aberration) with TIPA were available for review. The results for these studies were negative.

TIPA is not expected to be carcinogenic since there were no triggers for carcinogenicity in the published study and a lack of systemic toxicity in the 1-generation reproduction study in rats as well as a negative response for mutagenicity. Also, TIPA is not listed as a carcinogen by ACGIH, IARC, NTP, or CA Prop 65.

Metabolism studies demonstrated that TIPA was rapidly and extensively absorbed with a minimum of 83% oral absorption. Virtually the entire absorbed dose was rapidly excreted primarily as unchanged TIPA in the urine of treated rats.

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 TIPA used for human risk assessment is shown in the Table below. The 90-day toxicity study in the dog was selected for all exposure scenarios and durations for this risk assessment. The rationale for selecting this study is as follows. There was no toxicity observed at the highest dose (272 mg/kg/day) tested in the 90-day dog study. Toxicity was not observed in the 1-generation reproduction toxicity study in the rat at 609 mg/kg/day, the highest dose tested. In a 14-day toxicity study via drinking water, the NOAEL was 1,200 mg/kg/day. Although, the 30-day toxicity study via drinking water in the rat has a NOAEL of 140 mg/kg/day, there is no detail provided for microscopic findings in various organs. In addition, these findings were not reproduced in the 1-generation reproduction toxicity study in the rat. Therefore, less confidence was placed on the 30-day toxicity study in the rat. Finally, based on an EPA retrospective analysis, it was concluded that the 90-day toxicity and the 1-year toxicity studies in the dog are comparable. Therefore, based on the overall weight of evidence, the toxicity study in the dog provided a good basis for establishing the chronic reference dose (cRfD).

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

i. Acute exposure. No adverse effects attributable to a single exposure of TIPA were seen in the toxicity databases. Therefore, an acute dietary risk assessment for TIPA 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 TIPA. 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. TIPA is not expected to be carcinogenic since there were no triggers for carcinogenicity in the published study and a lack of systemic toxicity in the 1-generation reproduction study in rats as well as a negative response for mutagenicity. Since the Agency has not identified any concerns for carcinogenicity relating to TIPA, a cancer dietary exposure assessment 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 TIPA, a conservative drinking water concentration value of 100 parts per billion 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).

TIPA 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 TIPA as inert ingredients. The TIPA inerts may be present in consumer personal (care) products and cosmetics (at concentrations up to 1%). 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 TIPA in pesticide formulations (outdoor scenarios) and TIPA in disinfectant-type uses (indoor scenarios). 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.

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

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 either the developmental study with DIPA or the one generation reproduction study with TIPA in the rat. There were no toxic effects observed in parents nor offspring in either study at the highest doses tested, 1,000 and 700 mg/kg/day, respectively. A developmental toxicity study in rabbits is not available in the database. However, the concern for the lack of this study is low because no systemic toxicity was observed at the limit dose in the developmental and reproduction studies in rats (700 mg/kg/day). Also, other studies in the database such as the 90-day toxicity study in the dog and the 14-day toxicity study via drinking water in the rat do not show significant systemic toxicity.

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 TIPA is adequate.

ii. There is no indication that TIPA is a neurotoxic or immunotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that DIPA or TIPA result in increased susceptibility in in utero rats in the prenatal developmental studies or in young rats in the 1-generation reproduction study, respectively.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on the assumptions of 100% crop treated and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to TIPA 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 TIPA.

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, TIPA 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 TIPA from food and water will utilize 22.9% 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 TIPA 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).

TIPA 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 TIPA.

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 679 for both adult males and females. Adult residential exposure combines high end dermal and inhalation handler exposure from indoor hand wiping with a high end post application dermal exposure from contact with treated lawns. EPA has concluded the combined short-term aggregated food, water, and residential exposures result in an aggregate MOE of 337 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 TIPA 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).

TIPA 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 TIPA.

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 1,114 for adult males and females. Adult residential exposure includes 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 387 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 TIPA is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. TIPA is not expected to be carcinogenic since there were no triggers for carcinogenicity in the published study and a lack of systemic toxicity in the 1-generation reproduction study in rats as well as a negative response for mutagenicity.

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 TIPA 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.

The Agency is not aware of any country requiring a tolerance for 2-Propanol, 1,1′,1′′-nitrilotris- nor have any CODEX Maximum Residue Levels (MRLs) been established for any food crops at this time.

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for TIPA (CAS No. 122-20-3) when used as an inert ingredient (used as a neutralizer) in pesticide formulations applied to growing crops and raw agricultural commodities pre- and post-harvest without limitation.

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) (Public Law 104-4).

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

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

EPA Region III is publishing this direct final Notice of Partial Deletion of portions of the Letterkenny Army Depot Southeastern (SE) Area and Letterkenny Army Depot Property Disposal Office (PDO) Area (Sites) from the National Priorities List (NPL). This partial deletion pertains to the soil and groundwater of parcels 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91. The NPL constitutes Appendix B of 40 CFR part 300, which is the Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). This partial deletion of the Letterkenny Army Depot SE and PDO Areas is proposed in accordance with 40 CFR 300.425(e) and is consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the National Priorities List. 60 FR 55466 (Nov. 1, 1995). As described in 300.425(e)(3) of the NCP, a portion of a site deleted from the NPL remains eligible for Fund-financed remedial action if future conditions warrant such actions.

Because EPA considers this action to be noncontroversial and routine, this action will be effective September 21, 2010 unless EPA receives adverse comments by August 23, 2010. Along with this direct final Notice of Partial Deletion, EPA is co-publishing a Notice of Intent for Partial Deletion in the “Proposed Rules” section of the Federal Register. If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely withdrawal of this direct final Notice of Partial Deletion before the effective date of the partial deletion and the partial deletion will not take effect. EPA will, as appropriate, prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Partial Deletion and the comments already received. There will be no additional opportunity to comment.

Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the parcels 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 of the Letterkenny Army Depot SE and PDO Areas and demonstrates how they meet the deletion criteria. Section V discusses EPA's action to partially delete the parcels from the NPL unless adverse comments are received during the public comment period.

The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the Commonwealth, whether any of the following criteria have been met:

i. Responsible parties or other persons have implemented all appropriate response actions required;

ii. All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or

iii. The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.

Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.

The following procedures apply to the deletion of parcels 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 of the Letterkenny Army Depot SE and PDO Areas:

(1) EPA has consulted with the Commonwealth of Pennsylvania prior to developing this direct final Notice of Partial Deletion and the Notice of Intent for Partial Deletion co-published in the “Proposed Rules” section of the Federal Register.

(2) EPA has provided the Commonwealth 30 working days for review of this notice and the parallel Notice of Intent for Partial Deletion prior to their publication today, and the Commonwealth, through the Pennsylvania Department of Environmental Protection (PADEP), has concurred on the partial deletion of the Sites from the NPL, with the condition that future use of the deleted parcels remains commercial/industrial.

(3) Concurrently with the publication of this direct final Notice of Partial Deletion, a notice of the availability of the parallel Notice of Intent for Partial Deletion is being published in a major local newspaper, The Chambersburg Public Opinion. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent for Partial Deletion of the Sites from the NPL.

(4) The EPA placed copies of documents supporting the partial deletion in the deletion docket and made these items available for public inspection and copying at the Sites' information repositories identified above.

(5) If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Partial Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Partial Deletion and the comments already received.

Deletion of a portion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a portion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a portion of a site from the NPL does not preclude eligibility for further response actions, should future conditions warrant such actions.

The following information provides EPA's rationale for deleting portions of the Sites from the NPL:

Letterkenny Army Depot (LEAD) is located in south-central Pennsylvania in Franklin County, 5 miles north of the Borough of Chambersburg. The Depot covers 19,243 acres, most of which is devoted to ammunition storage. LEAD was the subject of two listings on the National Priorities List (NPL). The first was for the Southeastern (SE) Area, and the second was for the Property Disposal Office (PDO) Area. These two areas are separated by a major groundwater/surface-water drainage divide. The industrial and maintenance areas, which are primarily located in the southeastern corner of LEAD, encompass approximately 2,500 acres and include warehousing, vehicle storage, administration, industrial/maintenance, recreational activities, and housing. The infrastructure of this area includes roads; permanent, semi-permanent, and temporary structures; and utilities. Approximately 1,235 acres at LEAD have been designated for “realignment” under the Base Realignment and Closure (BRAC) initiative. “Realignment” means that the mission at LEAD is changing and approximately 1,235 acres at LEAD have been designated for release and transfer (i.e., “to-be-excessed” or to transfer ownership). The BRAC area is concentrated in the southeastern portion of LEAD, but is located in both the PDO and SE Areas. The BRAC area is being transferred to the Letterkenny Industrial Development Authority (LIDA) in phases. To date, LEAD has completed three parcel transfer phases, covering 761 acres. The Phase I parcels were transferred in 1998. The Phase II parcels were transferred in 2002. The Phase III parcels were transferred in 2004.

LEAD was originally established as an ammunition storage facility, Letterkenny Ordnance Depot, in 1942. A vehicle maintenance program was started in 1947. In subsequent years additional missions were added and the facility was renamed the Letterkenny Army Depot in 1962. The principal missions at LEAD currently include maintenance, modification, storage, and demilitarization operations on tactical missiles, conventional ammunition, and tactical wheeled vehicles. Operations conducted at LEAD involved cleaning, stripping, plating, lubrication, demolition, chemical/petroleum transfer/storage, and washout/deactivation of ammunition. Many of these missions/activities involved the use and/or disposal of chlorinated solvents, primarily trichloroethene (TCE) and 1,1,1-trichloroethane (TCA), along with petroleum hydrocarbons and other solvents.

The Letterkenny Army Depot SE Area (EPA ID PA6213820503) was listed on the NPL in the final rule appearing in the 7/22/87 Federal Register (52 FR 27620-27642).

The Letterkenny Army Depot PDO Area (EPA ID PA2210090054) was listed on the NPL in the final rule appearing in the 3/13/89 Federal Register (54 FR 10512-10517).

The parcels to be deleted from the NPL are all in an area known as the Southern Martinsburg Shale Region (SMSR), which is an area underlain by the Martinsburg Shale. These parcels are located in both the SE Area and the PDO Area. All of these parcels have been transferred from the Army to the LIDA under the BRAC Act of 1995. These parcels have been incorporated into the Cumberland Valley Business Park which is a commercial/industrial business park. The property consists of industrial land, developed land, small stands of trees, open grassy areas, commercial recreational areas (golf course and community center), administration buildings, and former military housing. No wetlands are located within the parcels, and no Federal or state threatened or endangered species are known or suspected to exist within the parcels. Land located within an approximately 0.5-mile radius of the parcels includes industrial land to the north (including land to be retained by the Army), an industrial area to the east (other BRAC sites as well as land to be retained by the Army), agricultural land to the south, and industrial land to the west (other BRAC property). The parcels are accessible to the general public via Coffey Avenue, which was transferred to LIDA and is maintained by the local townships.

This partial deletion covers the following parcels: 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 (See Table 1).

Parcel 24, which includes Building 500 and adjacent lands, was identified through historical aerial photographs as having been used for open vehicle storage early in LEAD's operation (post World War II). Two test trenches were completed in this parcel, and one sample was analyzed for Target Analyte List (TAL) metals and total petroleum hydrocarbons (TPH). The only compound that exceeded the screening criteria was arsenic, which slightly exceeded the EPA Region III risk-based concentration (RBC). EPA and PADEP, along with the Army, as part of the BRAC Cleanup Team (BCT), agreed that the detected concentration did not warrant further remedial action for industrial use. Arsenic is a naturally occurring metal, and arsenic results obtained at LEAD are not inconsistent with the published background concentrations for this metal in Pennsylvania. Residential and child-intense use scenarios were not evaluated.

No evidence of soil contamination was identified for these two parcels and therefore no further work was necessary.

At the time of the RI/FS for the Phase I Parcels, it was believed that there was groundwater contamination underlying all of the Phase I parcels. The human health risk assessment showed unacceptable risk if groundwater contact and use were unrestricted. The FS evaluated institutional controls as a remedy to restrict the property for commercial and industrial use only and to prevent exposure to the underlying groundwater.

The Phase I Parcels ROD was signed in September 1998. The selected remedy in the Phase I ROD was institutional controls. This was a final remedy with respect to soils, and an interim remedy for groundwater. The selected remedy included the following components:

■ Restricting the property for commercial and industrial use only.

■ Not permitting soil excavation activities below a depth of 3 feet above the water table without prior approval of the Army.

■ Not permitting construction of any subsurface structure for human occupation without the prior approval of the Army, PADEP, and the EPA.

■ Restricting access or use of the groundwater underlying the property without the prior written approval of the Army, PADEP, and the EPA.

No evidence of soil contamination was identified for these three parcels and therefore no further work was necessary.

At the time of the Phase II transfer, it was believed that the groundwater underlying all of the Phase II parcels was contaminated with or potentially contaminated with volatile organic compounds. To expedite transfer, the Army and LIDA defined the Phase II parcels to exclude the groundwater. The Phase II parcels are defined to include only the surface structures and soil to a depth of 8 feet below ground surface (ft bgs), which is above the seasonal high groundwater table. The FS evaluated institutional controls as a remedy to prevent exposure to the underlying groundwater.

The Phase II Parcels ROD was signed in July 2001. The Phase II ROD determined that no action is necessary to protect public health or welfare, or the environment from the soil at parcels 2-53, 2-54 and 2-70. Because of the suspected groundwater contamination throughout the Phase II parcels, the selected interim remedy for groundwater in the Phase II ROD consisted of land use controls. The land use controls include the following restrictions:

■ Prohibiting soil excavation, digging, drilling, or other soil-disturbing activities below a depth of 3 ft above the water table without the prior approval of the Army.

■ Prohibiting access to or the use of the groundwater underlying the Phase II parcels without the prior approval of the Army, PADEP, and EPA.

■ Prohibiting construction of any subsurface structure for human occupation without the prior approval of the Army, PADEP, and EPA.

LIDA's final reuse plan calls for industrial/commercial use for the majority of the Phase II parcels. There are zoning restrictions imposed by Greene Township to preclude residential use of land that includes Parcels 2-53, 2-54, and 2-70. However, those restrictions are independent of the NPL status of the Site and are not a result of environmental contamination.

Parcel 3-89:

Parcel 3-89 comprises the majority of the Phase III parcels/SMSR area and is located in both the PDO and SE Areas. The parcel consists of approximately 191 acres on the northern side of Carbaugh Avenue and the western side of Coffey Avenue. Soil investigations were conducted at the Open Vehicle Storage Area, Former Uncurbed Aboveground Storage Tank (AST) North of Building 532, and the Backwash Discharge Area from the Water Treatment Plant. The soil investigations are summarized in the following paragraphs.

The OVSA comprises the majority of Parcel 3-89. From approximately 1947 and continuing until the spring of 1998, the OVSA site was used for the storage of military vehicles. The most recent past practice of storage required that the vehicles be drained of fluids (such as diesel fuel, oil, and other engine fluids) before being stored. However, interviews with former employees indicate that the vehicles were formerly stored “wet,” meaning that they were stored with the fluids still in the vehicle, and that the vehicles' fluids may have leaked onto the ground before they were refurbished.

Remedial Investigations were conducted at the OVSA site in 1998, 1999, and 2000. The investigations showed possible risks associated with elevated levels of a group of semivolatile organic compounds (SVOCs) referred to as polycyclic aromatic hydrocarbons (PAHs) in soil. An engineering evaluation/cost analysis (EE/CA) was written to evaluate the need for a removal action. Based on the EE/CA findings a Removal Action was conducted in 2000. The cleanup levels used for the removal action were developed based on a future commercial/industrial post-removal reuse of the site. Approximately 45,000 tons of soil contaminated with PAHs were excavated and disposed of at approved off-site waste disposal facilities. Confirmatory sampling conducted after the removal action showed that the remaining concentrations of PAHs were at or below risk-based standards. A post-removal risk assessment was performed assuming a future commercial/industrial use as well as a potential future residential (unrestricted) use. The risk assessment showed concentrations of chemicals found in site soils, sediments, surface water, and groundwater posed no unacceptable risks to people, plants, or animals based on current and future commercial/industrial reuse. Risks to people based on a theoretical future residential use are within acceptable limits.

This is a small site that consists of a former aboveground storage tank (AST) area. Initially, there was an uncurbed single-walled AST (275 gallons) located north of Building 532 that stored gasoline used to fuel golf carts. This single-walled AST was replaced by a double-walled AST. It is unknown how long the single-walled AST was in service. The soils near the uncurbed AST were not investigated prior to the change in ASTs. The double-walled AST was still in place at the time of the remedial investigation in 1999; however the double-walled AST has subsequently been removed because the golf course converted to electric golf carts.

An investigation was completed to determine if the operation of the former AST at the site had caused a release of contaminants to site soil. Soil sampling was performed in April 1999. Soil borings, soil sampling and analysis, data validation, and surveying were performed. The investigation results did not indicate any chemicals of concern (COCs) in soil and there were no potential sources of groundwater contamination found. Only two chemicals (acetone and lead) were identified as chemicals of potential concern (COPCs) based on a comparison of maximum chemical concentrations to the lowest regulatory residential benchmarks. However, the remedial investigation/risk assessment showed that concentrations of chemicals found in site soils pose no unacceptable risks to people based on current and likely future commercial/industrial use. Risks to people are also within acceptable limits based on a theoretical future residential use. There is minimal habitat available capable of sustaining plants and animals at this site; therefore, ecological risks were not evaluated.

This site is located in the eastern part of the parcel along Coffey Avenue, near the water treatment plant for the potable water supply. In the past, sediments that accumulated in the raw water line were flushed out in the western area of the site. In the past, fluffy material (referred to as “flocculant”), which primarily consists of suspended solids removed from the water during the treatment process, was discharged to the eastern area of the site for settling.

An investigation was completed to determine if the former water treatment plant flocculant and backwash sediment disposal practices had caused a release of contaminants to site soil and sediments. Field activities were performed in October 1998. Soil borings, soil and drainage ditch soil sampling and analysis, sediment sampling and analysis, data validation, and surveying were performed. The investigation results did not indicate any COCs in soil and there were no potential sources of groundwater contamination found. Various metals were identified as COPCs based on a comparison of maximum chemical concentrations to the lowest regulatory residential benchmarks. However, the remedial investigation/risk assessment showed that concentrations of chemicals found in site soils pose no unacceptable risks to people, plants, or animals based on current and likely future commercial/industrial uses. Risks to people are also within acceptable limits based on a theoretical future residential use.

Parcel 3-90 is approximately 8 acres in size and is located south of Carbaugh Avenue and west of Coffey Avenue. Parcel 3-90 is located in both the PDO and SE Areas. There are no structures on this parcel. This parcel is currently open land and has been an open area in the past with no apparent storage or industrial activities. No further work was necessary.

Parcel 3-91 is approximately 1.5 acres in size and is located east of Coffey Avenue and north of Texas/Innovation Avenue in the southeastern corner of the SMSR. Parcel 3-91 is located entirely within the SE Area. There are no structures on Parcel 3-91. This parcel consists entirely of the western portion of the Building 400 Series Fire Training Area (FTA) site where industrial activities occurred. The Building 400 Series FTA area had been reportedly used in the past for a short period of time as a fire-fighting training area where a large metal pan was placed on the ground and filled with various flammable liquids, which were ignited. There was no record of the exact location of the pan, years of use, or when or if the pan was removed from the area when training activities ended. Historical aerial photographs from 1949 and 1957 show several disturbed places in this area. Based on knowledge of typical fire-training activities at LEAD, materials burned at the site may have included waste oils. There were no structures or material/waste storage on the site at the time of the remedial investigation in 1998. The only structures in the vicinity of the site were several old barracks/office buildings, which are still located near the site.

An investigation was completed to determine if the former fire training activities had caused a release of contaminants to site soil. Field activities were performed in September 1998. A geophysical survey, test trenching, soil sampling and analysis, data validation, and surveying were performed. The investigation results did not indicate any COCs in soil and there were no potential sources of groundwater contamination found. One VOC (acetone), two SVOCs (PAHs), various metals, and polychlorinated dibenzo-p-dioxins/polychlorinated dibenzofurans (PCDDs/PCDFs) were identified as COPCs based on a comparison of maximum chemical concentrations to the lowest regulatory residential benchmarks. However, the remedial investigation/risk assessment showed that concentrations of chemicals found in site soils pose no unacceptable risks to people, plants, or animals based on current and likely future commercial-industrial use. Risks to people are also within acceptable limits based on a theoretical future residential use.

As stated above, all of the parcels in this partial deletion are in the SMSR. The SMSR contains an area of shale bedrock surrounded by downgradient limestone bedrock. This shale bedrock is generally more resistant to weathering than the surrounding limestone formations and therefore, forms the “highland” or elevated ridge areas. The SMSR straddles the boundary between the PDO and SE Area NPL Sites. Based on the geologic and topographic upgradient setting and the lack of industrial activities within the SMSR it was thought that the SMSR could be unaffected by the known and potential VOC sources located downgradient of the SMSR. Therefore a groundwater investigation was initiated in 1999 to prove that the SMSR was not impacted by any previous industrial activities at Letterkenny. Four rounds of groundwater sampling were conducted in late 1999 through 2000 and then in 2002. Results of the sampling showed that there is no VOC groundwater contamination in the SMSR. Without VOC groundwater contamination there is no potential for vapor intrusion risk throughout the SMSR. A screening level risk assessment showed that risks to people based on current and future commercial/industrial use are within acceptable limits. Risks to people based on a possible, but unlikely, residential use (including human consumption of site groundwater) are within acceptable limits. Based on the finding of no VOC contaminated groundwater, the PDO portion of the SMSR was redefined as PDO OU 7 and the SE portion was redefined as SE OU 13.

These parcels consist of land underneath parcels 2-53, 2-54, and 2-70, which were previously transferred as part of the Phase II BRAC property transfer at LEAD. These parcels consist of land starting 8 ft. below ground surface and extending to the center of the earth. They are located in the southern part of the SMSR/Phase III area within SE OU 13. As stated above, in the Phase II transfer, the entire land area was not originally transferred because it was thought the groundwater located underneath the land was potentially contaminated with VOCs. These parcels were investigated as part of the SMSR groundwater investigation described previously. The Army has completed its investigation and risk assessment for the SMSR groundwater and found no environmental concerns at the site. The top portions of these parcels were transferred with an interim remedy for groundwater consisting of restrictions on soil excavation and groundwater use because at that time it was thought that the groundwater underneath the parcels was contaminated. The Phase III ROD stated that the soil excavation and groundwater restrictions could be removed.

As stated above, all parcels subject to this partial deletion are part of the SMSR for Parcel 3-89, the Army, EPA, and PADEP have determined that risks to people, plants, and animals from potential contact with soils/sediments were acceptable at the OVSA, Former Uncurbed AST North of Building 532, and the Backwash Discharge Area sites and that no action is necessary to protect public health or welfare or the environment. For the OVSA site, this conclusion is based on the conditions of the site following the removal action that was performed in 2000 when PAH-contaminated soil was removed from the site. There were no environmental concerns in Parcels 3-90 and 3-91.

Based on the findings of the SMSR groundwater investigation, there is no VOC groundwater contamination and thus no unacceptable risks from groundwater in this area.

The Phase III ROD was signed in August 2003. Based on the results of the remedial investigations and risk assessments it was determined that No Further Action was necessary for the Phase III Parcels under CERCLA. The No Further Action remedy applies to the SMSR groundwater (PDO OU 7 and SE OU 13) and to the soils (PDO OU 6 and SE OU 8). In addition the ROD stated that no further action was necessary for the groundwater underlying Phase I Parcels 24, 27, 28 and Phase II Parcels, 2-53, 2-54, 2-70 and the underlying Parcels 2-53L, 2-54L, and 2-70L because they are a part of SE OU 13.

There are no response actions, cleanup goals, or operation & maintenance due to the No Further Action decision in the Phase III ROD for both soils and groundwater. Land use controls restrict the use of Phase I parcels to commercial and industrial use only and prohibit residential use.

EPA concurred with the Army's first Five-Year Review for the PDO Area on March 12, 2007. EPA concurred on the first Five-Year Review for the SE Area in November 2001 and the second Five-Year Review for the SE Area on June 24, 2008.

In the 2007 Five-Year Review for the PDO Area, it was determined that the No Further Action Remedy for PDO OU 7 and a portion of PDO OU 6 is still considered protective of human health and the environment. This Five-Year Review did not find any issues relating to the parcels included in this partial deletion.

In the 2008 Five-Year Review for the SE Area, it was determined that the No Further Action Remedy for SE OU 13 and a portion of SE OU 8 is still considered protective of human health and the environment. This Five-Year Review did not find any issues relating to the parcels included in this partial deletion.

Pursuant to CERCLA section 121(c) and the NCP, the next PDO Area five-year review will be conducted in 2012 and the next SE Area five-year review will be conducted in 2013 to ensure other OUs at each respective Superfund Site where waste was left in place are protective of human health and the environment.

Public participation activities have been satisfied as required in CERCLA section 113(k), 42 U.S.C. 9613(k), and CERCLA section 117, 42 U.S.C. 9617. Documents in the deletion docket which EPA relied on for recommendation of the deletion from the NPL are available to the public in the information repositories.

Public participation related to parcels in deletion package:

No further response action under CERCLA is appropriate. EPA has determined based on the investigations conducted at these parcels and documented by the 3 RODs described above, that the Army has implemented all appropriate response actions required. Through the previous PDO and SE areas five-year reviews, EPA has also determined that the Phase III Parcels No Further Action remedy is considered protective of human health and the environment and, therefore, taking of additional remedial measures is not necessary. Other procedures required by 40 CFR 300.425(e) are detailed in Section III.

The EPA, with concurrence dated March 2, 2010 of the Commonwealth of Pennsylvania through the Pennsylvania Department of Environmental Protection, has determined that all appropriate response actions under CERCLA have been completed. Therefore, EPA is deleting parcels 24, 27, 28, 2-53, 2-53L, 2-54, 2-54L, 2-70, 2-70L, 3-89, 3-90, and 3-91 of the Letterkenny Army Depot SE and PDO Areas Sites from the NPL.

Because EPA considers this action to be noncontroversial and routine, EPA is taking it without prior publication. This action will be effective September 21, 2010 unless EPA receives adverse comments by August 23, 2010. If adverse comments are received within the 30-day public comment period, EPA will publish a timely withdrawal of this direct final notice of partial deletion before the effective date of the partial deletion and it will not take effect. EPA will prepare a response to comments and continue with the deletion process on the basis of the notice of intent to partially delete and the comments already received. There will be no additional opportunity to comment.

In Title 47 of the Code of Federal Regulations, Parts 20 to 39, revised as of October 1, 2009, on page 148, § 24.232 is revised and on page 336, in § 27.50, paragraph (d) is revised to read as follows:

DoD, GSA and NASA published a document in the Federal Register of July 2, 2010 (75 FR 38684) amending FAR 52.204-11(d)(10). The amendment was incorrect.

As published, the interim rule contains a typographical error which needs to be corrected.

On June 30, 2010 (75 FR 37739), a temporary rule was published adjusting the FY 2010 Trimester 2 and 3 Loligo squid quotas. The temporary rule correctly revised the Trimester 3 quota from the initial quota of 16,461,920 lb (7,467 mt) to a new quota of 23,743,619 lb, but erroneously specified the metric equivalent as 13,770 mt. The corrected metric equivalent is 10,770 mt.

In rule FR Doc. 2010-15933 published on June 30, 2010, (75 FR 37739) make the following correction. On page 37739, in the third column, correct “(13,770 mt)” to read “(10,770 mt)”.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2010 Pacific ocean perch sideboard limit established for catcher/processors participating in the limited access or opt-out fisheries that are subject to sideboard limits in the Central GOA Rockfish Program in the Western Yakutat district is 1,099 metric tons (mt). The sideboard limit is established by the final 2010 and 2011 harvest specifications for groundfish of the GOA (75 FR 11749, March 12, 2010) and as posted as the 2010 Rockfish Program Catcher/Processor Sideboards at http://alaskafisheries.noaa.gov/sustainablefisheries/goarat/default.htm.

In accordance with § 679.82(d)(7)(i)(A), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2010 Pacific ocean perch sideboard limit established for catcher processors participating in the limited access or opt-out fisheries in the Western Yakutat district will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 999 mt, and is setting aside the remaining 100 mt as bycatch to support other anticipated groundfish fisheries. In accordance with § 679.82(d)(7)(ii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for the Pacific ocean perch sideboard limit established for catcher/processors participating in the limited access or opt-out fisheries in the Western Yakutat district of the Gulf of Alaska.

After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Pacific ocean perch sideboard limit for catcher/processors participating in the limited access or opt-out fisheries in the Western Yakutat district. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of July 19, 2010.

The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

This action is required by § 679.82 and is exempt from review under Executive Order 12866.