Federal Register Vol. 80, No.227,

We are issuing this final rule without prior notice and opportunity for comment. The Administrative Procedure Act (APA) exempts rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts” from the statutory requirement for prior notice and opportunity for comment. 5 U.S.C. 553(a)(2). However, FCIC is providing a 60-day comment period and we invite you to participate in this rulemaking by submitting written comments. We will consider the comments we receive and may conduct additional rulemaking based on the comments.

The Office of Management and Budget (OMB) has determined that this rule is not-significant for the purpose of Executive Order 12866 and, therefore, it has not been reviewed by OMB.

Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the collections of information in this rule have been approved by OMB under control number 0563-0085.

FCIC is committed to complying with the E-Government Act of 2002, 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.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.

It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Program requirements for the Federal crop insurance program are the same for all producers regardless of the size of their farming operation. For instance, all producers are required to submit an application and acreage report to establish their insurance guarantees and compute premium amounts, and all producers are required to submit a notice of loss and production information to determine the amount of an indemnity payment in the event of an insured cause of crop loss. Whether a producer has 10 acres or 1000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act authorizes FCIC to waive collection of administrative fees from limited resource farmers. FCIC believes this waiver helps to ensure that small entities are given the same opportunities as large entities to manage their risks through the use of crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have an impact on small entities, and therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).

This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.

This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.

This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC or action by FCIC to require the insurance provider to take specific action under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action against FCIC for judicial review may be brought.

This action is not expected to have a significant economic impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.

FCIC amends the Area Risk Protection Insurance Regulations (7 CFR part 407) by revising § 407.9 Area Risk Protection Insurance Policy and § 407.13 Forage Crop Insurance Provisions to be effective for the 2017 succeeding crop years. The revisions meet certain goals of ACRSI, which include elimination of duplicate information collection, simplification of producer reporting, and incorporating language contained in section 12305(b)(1)(B) of the 2014 Farm Bill prohibiting FCIC from offering the CAT level of coverage for any crops or grasses used for grazing.

Previously, changes made to the Federal crop insurance policies codified in the Code of Federal Regulations were required to be implemented through the rulemaking process. Such action was not required by the Administrative Procedures Act because contracts were exempt from notice and comment rulemaking and the crop insurance policy is a contract. However, a prior Secretary of Agriculture published a notice in the Federal Register stating that the Department of Agriculture would, to the maximum extent practicable, use the notice and comment rulemaking process when making program changes, including those involving contracts. FCIC has complied with this notice over the subsequent years. Recently, the current Secretary of Agriculture has published a notice in the Federal Register rescinding the prior notice, thereby making contracts again exempt from the notice and comment rulemaking process. However, FCIC values the input it receives through comments and has elected to solicit comments to this final rule. FCIC will consider all of the comments that are received and may conduct additional rulemaking based on the comments.

For these reasons, these policy changes are effective upon publication at the Office of the Federal Register.

The specific revisions to Area Risk Protection Insurance Policy (7 CFR 407.9) are as follows:

1. Section 8—FCIC is revising paragraph (e)(2). The current provisions regarding the insured's ability to revise an acreage report state that consent may only be provided if the information on the acreage report is clearly transposed, or the insured provides adequate evidence that the insurance company or someone from USDA has committed an error regarding the information on the acreage report. FCIC is revising this provision to include language that gives FCIC the flexibility through the Crop Provisions or through the Special Provisions to provide additional circumstances for which insureds may revise their acreage reports. This change is necessary due to changes in the ARPI Forage Crop Provisions stated below that allow acreage reports be revised when the acreage has suffered winterkill. FCIC is also revising the paragraph to improve readability.

The specific changes to ARPI Forage crop insurance provisions (7 CFR 407.13) are as follows:

1. Section 1—FCIC is revising the definition of “harvest.” The definition of “harvest” states “removal of the forage from the field, and rotational grazing.”

However, the 2014 Farm Bill prohibits FCIC from offering the CAT level of coverage for any crops or grasses used for grazing. Further, the Noninsured Crop Assistance Program (NAP) offers coverage at the CAT and additional levels of coverage. To avoid confusion between the benefits available, FCIC is removing the option to purchase coverage for grazing at the additional and CAT level of coverage so that forage producers are eligible for at least the CAT level of coverage offered under other USDA programs. Therefore, FCIC is removing the term “rotational grazing,” from the definition of “harvest” and removing the definition of “rotational grazing” so that FCIC can continue to offer the CAT level of coverage to forage producers who do not graze acreage.

2. Section 5—FCIC is moving the cancellation date, termination date and contract change date 60 days earlier: For the termination and cancellation dates, from November 30 to September 30, and for the contact change date, from August 31 to June 30. A goal under ACRSI is to establish one acreage reporting date for each commodity that will be used for USDA programs. For perennial forage, ACRSI established two commodities for perennial forage: an established stand and fall-seeded commodity; and a spring-seeded commodity. Each commodity requires its own acreage reporting date: One in the fall and one in the spring, respectively. In order to be insured under the ARPI forage policy, perennial forage must have an established stand for insurance to attach. Therefore, its acreage reporting date needs to be in the fall in order for its acreage reporting date to align with the acreage reporting date for established stand perennial forage insured under other plans of insurance. The acreage reporting date for established stand and fall-seeded perennial forage insured under other plans of insurance FCIC offers is set at November 15 or December 15, depending on the state. The fall date is necessary for the other perennial forage plans of insurance because those plans of insurance provide coverage for damage due to winterkill. Therefore, FCIC must require producers to report their acreage prior to the possibility of an occurrence of winterkill. In order to move the acreage reporting date, which is contained in the actuarial documents, from the current date of July 15 to November 15 or December 15, depending on the state, FCIC must also make adjustments in the Crop Provisions to these other program dates: cancellation and termination dates and the contract change date. This change will make the program dates for forage insured under ARPI consistent with the program dates for forage insured under other plans of insurance.

3. Section 6—FCIC is removing this section and add another in its place. The current section 6 addresses when premium is earned and payable, and overrides section 7(e) in the ARPI Basic Provisions. Basic Provisions section 7(e) states that premium is earned and payable at the time coverage begins, whereas section 6 of the Forage Crop Provisions states that premium is earned and payable on the acreage reporting date. Coverage for forage begins on the date the insurance company accepts the application, which is in the fall. Currently, premium for forage is not earned and payable at the time coverage begins, but rather on the acreage reporting date, which is approximately eight months after insureds submit their applications. Premium is earned and payable on the acreage reporting date because insureds have the opportunity at acreage reporting date to opt out of coverage if they can establish that their acreage was damaged by winterkill by reporting such acreage as uninsurable on the acreage report. Insureds do not owe premium on acreage damaged by winterkill if they report such acreage on the acreage report as uninsurable. Insureds do not know if their acreage is damaged by winterkill until mid-to-late spring. If insureds report such acreage as uninsurable, then they are not required to pay premium on that acreage. FCIC proposes to remove these provisions, which then makes section 7(e) of the Basic Provisions applicable. Therefore, premium will be earned and payable at the time coverage begins. This change will make forage insured under ARPI consistent with forage insured under the APH plan of insurance. As a result of another revision discussed below, insureds will have an opportunity to revise their acreage reports after the acreage reporting date to report their acreage damaged by winterkill as uninsurable acreage if they do not wish to insure that acreage and pay premium on it.

FCIC is adding a new section 6 titled “Report of Acreage.” The provisions in section 6 will allow insureds to submit a revised acreage report by a date specified in the Special Provisions if they want to report their acreage damaged by winterkill as uninsurable acreage. FCIC anticipates the date specified in the Special Provisions to be May 15. Without this provision, insureds would be required to insure and pay premium on acreage they currently are not required to insure under the ARPI Forage Crop Provisions.

Accordingly, as set forth in the preamble, the Federal Crop Insurance Corporation amends 7 CFR part 407 effective for the 2017 and succeeding crop years as follows:

This rule is issued under Marketing Order No. 959, as amended (7 CFR part 959), regulating the handling of onions grown in South Texas, 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 Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, South Texas onion handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable onions beginning August 1, 2015, and continue until amended, suspended, or 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. Such 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 increases the assessment rate established by the Committee for the 2015-16 and subsequent fiscal periods from $0.03 to $0.05 per 50-pound equivalent of onions.

The South Texas onion marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers and handlers of South Texas onions. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2012-13 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on June 25, 2015, and unanimously recommended 2015-16 expenditures of $149,807 and an assessment rate of $0.05 per 50-pound equivalent of onions. Budgeted expenditures for the 2014-15 fiscal period were the same. The assessment rate of $0.05 is $0.02 higher than the rate currently in effect. With the 2015-16 crop estimated to be four million 50-pound equivalents, one million less than last year's estimate, the current assessment rate would be insufficient to cover the Committee's anticipated expenditures. Further, due to a crop failure during the 2014-15 season, the Committee has depleted its reserve funds. With the Committee's recommended $0.02 increase, assessment income should approximate $200,000. This should provide sufficient funds to cover anticipated 2015-16 expenses and add funds to the Committee's authorized reserve.

The major expenditures recommended by the Committee for the 2015-16 year include $50,000 for compliance, $37,050 for administrative, and $32,942 for management. Budgeted expenses for these items were the same in 2014-15.

The assessment rate recommended by the Committee was derived by considering anticipated expenses, expected shipments of South Texas onions, and the level of funds in reserve. As mentioned earlier, onion shipments for the year are estimated at four million 50-pound equivalents which should provide $200,000 in assessment income. Income derived from handler assessments, along with interest income, should be adequate to cover budgeted expenses. Funds in the reserve (currently $23,906) will be kept within the maximum permitted by the order (approximately two fiscal periods' expenses as authorized in § 959.43).

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2015-16 budget and those for subsequent fiscal periods would be reviewed and, as appropriate, approved by USDA.

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 rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses 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 60 producers of onions in the production area and approximately 20 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,000,000 (13 CFR 121.201).

According to Committee data and information from the National Agricultural Statistical Service (NASS), the average price for South Texas onions during the 2013-2014 season was around $12.00 per 50-pound equivalent and total shipments were approximately 4.4 million 50-pound equivalents. Based on this information and data on acreage and yield, the majority of South Texas onion producers would have annual receipts of less than $750,000. In addition, based on available information, more than 50 percent of South Texas onion handlers could be considered small businesses under SBA's definition. Thus, the majority of South Texas onion producers and handlers may be classified as small entities.

This rule increases the assessment rate established for the Committee and collected from handlers for the 2015-16 and subsequent fiscal periods from $0.03 to $0.05 per 50-pound equivalent of Texas onions. The Committee unanimously recommended 2015-16 expenditures of $149,807 and an assessment rate of $0.05 per 50-pound equivalent. The assessment rate of $0.05 is $0.02 higher than the 2012-13 rate. The quantity of assessable onions for the 2015-16 fiscal period is estimated at four million 50-pound equivalents. Thus, the $0.05 rate should provide $200,000 in assessment income and be adequate to meet this year's expenses.

The major expenditures recommended by the Committee for the 2015-16 fiscal period include $50,000 for compliance, $37,050 for administrative, and $32,942 for management. Budgeted expenses for these items were the same during the 2014-15 fiscal period.

With the 2015-16 crop estimated to be four million 50-pound equivalents, one million less than last year's estimate, the current assessment rate would be insufficient to cover the Committee's anticipated expenditures. Further, due to a crop failure during the 2014-15 season, the Committee has depleted its reserve funds. The Committee recommended the $0.02 increase to provide sufficient funds to cover anticipated 2015-16 expenses and add funds to the Committee's authorized reserve.

Prior to arriving at this budget and assessment rate, the Committee considered information from various sources, such as the Committee's Budget and Personnel Committee. Alternative expenditure levels were discussed by this group, based upon the relative value of various activities to the South Texas onion industry. The Committee ultimately determined that 2015-16 expenditures of $149,807 were appropriate, and the recommended assessment rate, along with interest income, would generate sufficient revenue to meet its expenses.

A review of historical information and preliminary information pertaining to the upcoming season indicates that the grower price for the 2015-16 season should average around $9.55 per 50-pound equivalent of onions. Therefore, the estimated assessment revenue for the 2015-16 fiscal period as a percentage of total grower revenue could be approximately 0.52 percent for the season.

This action increases the assessment obligation imposed on handlers. While assessments impose some additional costs on handlers, the costs are minimal and uniform on all handlers. However, these costs are offset by the benefits derived by the operation of the marketing order. In addition, the Committee's meeting was widely publicized throughout the South Texas onion industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the June 25, 2015, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 (Vegetable and Specialty Crops). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.

This rule imposes no additional reporting or recordkeeping requirements on either small or large South Texas onion 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.

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

A proposed rule concerning this action was published in the Federal Register on September 18, 2015 (80 FR 56399). Copies of the proposed rule were also mailed or sent via facsimile to all onion handlers. Finally, the proposal was made available through the Internet by USDA and the Office of the Federal Register. A 30-day comment period ending October 19, 2015, was provided for interested persons to respond to the proposal. No comments were received.

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/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Jeffrey Smutny at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

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

Pursuant to 5 U.S.C. 553, it also found and determined that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because the crop year began on August 1, 2015, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable onions handled during such period. Further, handlers are aware of this rule which was recommended at a public meeting. Also, a 60-day comment period was provided for in the proposed rule.

For the reasons set forth in the preamble, 7 CFR part 959 is amended as follows:

This rule is issued under Marketing Agreement No. 125 and Order No. 966, both as amended (7 CFR part 966), regulating the handling of tomatoes grown in Florida, 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 Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, Florida tomato handlers are subject to assessments. Funds to administer the order are derived from such assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable Florida tomatoes beginning August 1, 2015, and continue until amended, suspended, or 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. Such 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 decreases the assessment rate established for the Committee for the 2015-16 and subsequent fiscal periods from $0.0375 to $0.03 per 25-pound carton of tomatoes.

The Florida tomato marketing order provides authority for the Committee, with the approval of USDA, to formulate an annual budget of expenses and collect assessments from handlers to administer the program. The members of the Committee are producers of Florida tomatoes. They are familiar with the Committee's needs and with the costs for goods and services in their local area and are thus in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2013-14 and subsequent fiscal periods, the Committee recommended, and USDA approved, an assessment rate that would continue in effect from fiscal period to fiscal period unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other information available to USDA.

The Committee met on August 25, 2015, and unanimously recommended 2015-16 expenditures of $1,513,177 and an assessment rate of $0.03 per 25-pound carton of tomatoes. In comparison, last year's budgeted expenditures were $1,823,925. The assessment rate of $0.03 is $0.0075 lower than the rate currently in effect. The budget recommended for 2015-16 include decreases in education and promotion expenditures and personnel costs. The Committee recommended decreasing the assessment rate to more closely align assessment income to the lower budget.

The major expenditures recommended by the Committee for the 2015-16 year include $435,377 for salaries, $400,000 for education and promotion, and $400,000 for research. Budgeted expenses for these items in 2014-15 were $498,500, $750,000, and $300,000, respectively.

The assessment rate recommended by the Committee was derived by reviewing anticipated expenses, shipments, funds from block grants, interest income, and available reserves. Florida tomato shipments for the year are estimated at 33 million 25-pound cartons which should provide $990,000 in assessment income. Income derived from handler assessments, along with funds from the Committee's authorized reserve, interest income, and funds from block grants, will be adequate to cover budgeted expenses. Funds in the reserve (currently $1,136,195) will be kept within the maximum permitted by the order of not to exceed one fiscal period's expenses as authorized in § 966.44.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the Committee or other available information.

Although this assessment rate is effective for an indefinite period, the Committee will continue to meet prior to or during each fiscal period to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of Committee meetings are available from the Committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate Committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The Committee's 2015-16 budget and those for subsequent fiscal periods will be reviewed and, as appropriate, approved by USDA.

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 rule 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 businesses 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 100 producers of tomatoes in the production area and approximately 80 handlers subject to regulation under the marketing order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,000,000 (13 CFR 121.201).

Based on industry and Committee data, the average annual price for fresh Florida tomatoes during the 2014-15 season was approximately $10.58 per 25-pound container, and total fresh shipments for the 2014-15 season were approximately 36.5 million cartons. Based on the average price, about 80 percent of handlers could be considered small businesses under SBA's definition. In addition, based on production data, grower prices as reported by the National Agricultural Statistics Service, and the total number of Florida tomato growers, the average annual grower revenue is below $750,000. Thus, the majority of handlers and producers of Florida tomatoes may be classified as small entities.

This rule decreases the assessment rate established by the Committee and collected from handlers for the 2015-16 and subsequent fiscal periods from $0.0375 to $0.03 per 25-pound carton of tomatoes. The Committee unanimously recommended 2015-16 expenditures of $1,513,177 and an assessment rate of $0.03 per 25-pound carton. The assessment rate of $0.03 is $0.0075 lower than the 2013-14 rate. The quantity of assessable tomatoes for the 2015-16 season is estimated at 33 million cartons. Thus, the $0.03 rate should provide $990,000 in assessment income. Income derived from handler assessments, along with funds from the Committee's authorized reserve, interest income, and funds from block grants, will be adequate to cover budgeted expenses.

The major expenditures recommended by the Committee for the 2015-16 year include $435,377 for salaries, $400,000 for education and promotion, and $400,000 for research. Budgeted expenses for these items in 2014-15 were $498,500, $750,000, and $300,000, respectively. The Committee recommended a decrease in the assessment rate based on a reduction in expenditures for education and promotion, and personnel expenses.

Prior to arriving at this budget and assessment rate, the Committee considered information from various sources, such as the Committee Executive Subcommittee, Research Subcommittee, and Education and Promotion Subcommittee. Alternative expenditure levels were discussed by these groups, based upon the relative value of various activities to the tomato industry. The Committee ultimately determined that assessment revenue, along with grant funds, funds from reserves and interest income, would generate sufficient revenue to meet its expenses.

A review of historical information and preliminary information pertaining to the upcoming crop year indicates that the average grower price for the 2015-16 season may be around $10.50 per 25-pound carton of tomatoes. Therefore, the estimated assessment revenue for the 2015-16 crop year as a percentage of total grower revenue could be approximately 0.3 percent.

This action decreases the assessment obligation imposed on handlers. Assessments are applied uniformly on all handlers, and some of the costs may be passed on to producers. However, decreasing the assessment rate reduces the burden on handlers. In addition, the Committee's meeting was widely publicized throughout the Florida tomato industry and all interested persons were invited to attend the meeting and participate in Committee deliberations on all issues. Like all Committee meetings, the August 25, 2015, meeting was a public meeting and all entities, both large and small, were able to express 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.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178 Vegetable and Specialty Crops. No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This action imposes no additional reporting or recordkeeping requirements on either small or large Florida tomato 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.

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

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/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Jeffery Smutny at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the Committee and other available information, it is hereby found that this 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 2015-16 fiscal period began on August 1, 2015, and the marketing order requires that the rate of assessment for each fiscal period apply to all assessable Florida tomatoes handled during such fiscal period; (2) the Committee needs to have sufficient funds to pay its expenses which are incurred on a continuous basis and this action decreases the assessment rate for assessable tomatoes beginning with the 2015-16 fiscal period; (3) handlers are aware of this action which was unanimously recommended by the Committee at a public meeting and is similar to other assessment rate actions issued in past years; and (4) this interim rule provides a 60-day comment period, and all comments timely received will be considered prior to finalization of this rule.

For the reasons set forth in the preamble, 7 CFR part 966 is amended as follows:

This rule is issued under Marketing Agreement and Order No. 989, both as amended (7 CFR part 989), regulating the handling of raisins produced from grapes 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 Orders 12866, 13563, and 13175.

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the marketing order now in effect, California raisin handlers are subject to assessments. Funds to administer the order are derived from assessments. It is intended that the assessment rate as issued herein will be applicable to all assessable raisins beginning on August 1, 2015, and continue until amended, suspended, or 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. Such 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 increases the assessment rate established by the committee for the 2015-16 and subsequent crop years from $14.00 to $17.00 per ton of California raisins handled.

Sections 989.79 and 989.80, respectively, of the order provide authority for the committee, with the approval of USDA, to formulate an annual budget of expenses, and to collect assessments from handlers to administer the program. The members of the committee are producers and handlers of California raisins. They are familiar with the committee's needs and with costs for goods and services in their local area, and are, thus, in a position to formulate an appropriate budget and assessment rate. The assessment rate is formulated and discussed in a public meeting. Thus, all directly affected persons have an opportunity to participate and provide input.

For the 2010-11 and subsequent crop years, the committee recommended, and USDA approved, an assessment rate that would continue in effect from crop year to crop year unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the committee or other information available to USDA.

The committee met on June 11, 2015, and recommended an assessment rate increase from $14.00 per ton to $17.00 per ton by a unanimous vote. At this meeting, the committee also recommended a budget for the 2015-16 crop year, with recommended expenses and contingency reserve totaling $5,832,496. The vote on this recommendation was also unanimous. The assessment rate of $17.00 per ton is expected to generate assessment income of $5,832,496, which should be sufficient to fund the 2015-16 expenses.

As previously stated, the committee's budget for the 2015-16 crop year is $5,832,496, and the assessment rate is $17.00 per ton, which is $3.00 per ton higher than the rate currently in effect.

The major expenditures recommended by the committee for the 2015-16 crop year include: Salaries and employee-related costs of $1,402,906; administration costs of $610,000; compliance activities costs of $30,000; research and studies costs of $129,000; operation and maintenance costs of the generic marketing programs of $3,520,178; and a contingency of $355,503. Subtracted from these expenses is $215,091, which represents reimbursable costs for the shared management of the State marketing program.

In comparison, last year's approved budgeted expenditures included: Salaries and employee-related costs of $1,337,100; administration costs of $493,500; compliance activities costs of $30,000; research and studies costs of $85,000; operation and maintenance costs of the generic marketing programs of $3,296,800; and a contingency of $100,000. Reimbursable costs for the shared management of the State marketing program of $166,860 were subtracted, resulting in a total approved budget for the 2014-15 crop year of $5,175,540.

The committee believes that more funds should be spent in promoting raisins internationally, including China. For that reason, budgeted expenses in those endeavors have been increased: Research and studies costs increased from $85,000 for the 2014-15 crop year to $129,000 for the 2015-16 crop year; and operation and maintenance costs of generic marketing programs increased from $3,296,800 for the 2014-15 crop year to $3,520,178 for the 2015-16 crop year. In addition, the committee included a contingency fund for unexpected expenses and opportunities that may occur during the year.

The quantity of assessable raisins for 2015-16 crop year was estimated to be 343,088 tons. At the assessment rate of $17.00 per ton, the anticipated assessment income would be $5,832,496. Sufficient income should be generated at the higher assessment rate for the committee to meet its anticipated expenses.

Pursuant to § 989.81(a) of the order, any unexpended assessment funds from the crop year must be credited or refunded to the handlers from whom collected.

The assessment rate established in this rule will continue in effect indefinitely unless modified, suspended, or terminated by USDA upon recommendation and information submitted by the committee or other available information.

Although this assessment rate will be in effect for an indefinite period, the committee will continue to meet prior to or during each crop year to recommend a budget of expenses and consider recommendations for modification of the assessment rate. The dates and times of committee meetings are available from the committee or USDA. Committee meetings are open to the public and interested persons may express their views at these meetings. USDA will evaluate committee recommendations and other available information to determine whether modification of the assessment rate is needed. Further rulemaking will be undertaken as necessary. The committee's 2015-16 budget and those for subsequent crop years, would be reviewed and, as appropriate, approved by USDA.

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 rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of businesses 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 3,000 producers of California raisins and approximately 20 handlers subject to regulation under the marketing order. The Small Business Administration defines small agricultural producers as those having annual receipts less than $750,000, and defines small agricultural service firms as those whose annual receipts are less than $7,000,000. (13 CFR 121.201.)

Based upon shipment data and other information provided by the committee, it may be concluded that a majority of producers and approximately 18 handlers of California raisins may be classified as small entities.

This rule increases the assessment rate established for the committee and collected from handlers for the 2015-16 and subsequent crop years from $14.00 to $17.00 per ton of assessable raisins acquired by handlers.

The committee reviewed and identified the expenses that are reasonable and necessary to continue program operations during the 2015-16 crop year. The resulting recommended budget totals $5,832,496 for the 2015-16 crop year. This represents an overall increase from the 2014-15 budget, which totaled $5,175,540. The 2015-16 budget includes additional expenditures to fund increased promotional programs in export markets, and a contingency fund of $355,503, which provides a safety net to cover unexpected expenses and opportunities that present themselves during the 2015-16 crop year.

The quantity of assessable raisins for 2015-16 crop year was estimated to be 343,088 tons. At the assessment rate of $17.00 per ton, the anticipated assessment income would be $5,832,496. Sufficient income should be generated at the higher assessment rate for the committee to meet its anticipated expenses.

The major expenditures recommended by the committee for the 2015-16 crop year include: Salaries and employee-related costs of $1,402,906; administration costs of $610,000; compliance activities costs of $30,000; research costs of $129,000; operation and maintenance costs of generic marketing programs of $3,520,178; and a contingency of $355,503.

In comparison, last year's approved budgeted expenditures included: Salaries and employee-related costs of $1,337,100; administration costs of $493,500; compliance activities costs of $30,000; research costs of $85,000; operation and maintenance costs of generic marketing programs of $3,296,800; and a contingency of $100,000. The total budget approved for the 2014-15 crop year was $5,175,540.

The committee believes that more funds should be spent in promoting raisins internationally, including China. For that reason, expenses for research and promotion activities have been increased: Operation and maintenance costs of generic marketing programs increased from $3,296,800 for the 2014-15 crop year to $3,520,178 for the 2015-16 crop year, and research costs have increased from $85,000 for the 2014-15 crop year to $129,000 for the 2015-16 crop year. In order to fund these additional expenditures, the committee recommended an increased assessment rate.

Pursuant to § 989.81(a) of the order, any unexpended assessment funds from the crop year must be credited or refunded to the handlers from whom collected.

Prior to arriving at this budget and assessment rate, the committee considered information from various sources, such as the committee's Audit and Marketing Subcommittees. Alternative spending levels were discussed by the Marketing and Audit Subcommittees, which met on June 8, 2015 and June 11, 2015, to review the committee's financial operations.

The committee ultimately decided that the recommended budget and assessment rate were reasonable and necessary to properly administer the order.

A review of statistical data on the California raisin industry indicates that assessment revenue has consistently been less than one percent of grower revenue in recent years. With a $17.00 assessment rate, assessment revenue is expected to remain at less than one percent of grower revenue.

Regarding the impact of this action on affected entities, this action increases the assessment obligation imposed on handlers. While increased assessments impose additional costs on handlers regulated under the order, the rates are uniform on all handlers, and proportional to the size of their businesses. It is expected that these costs would be offset by the benefits derived from the operation of the order.

In addition, the meetings of the Audit and Marketing Subcommittees, and the full committee were widely publicized throughout the California raisin industry, and all interested persons were invited to attend the meetings and encouraged to participate in committee deliberations on all issues. Like all subcommittee and committee meetings, the June 8, 2015 and June 11, 2015, meetings were public meetings, and all entities, both large and small, were able to express views on this issue.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0178, “Vegetable and Specialty Crops.” No changes in those requirements are necessary as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.

This rule imposes no additional reporting or recordkeeping requirements on either small or large California raisin 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. As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final 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.

A proposed rule concerning this action was published in the Federal Register on September 2, 2015 (80 FR 53022). Copies of the proposed rule were mailed or sent via facsimile or email to all raisin handlers. Finally, the proposal was made available through the Internet by USDA and the office of the Federal Register. A 30-day comment period ending October 2, 2015, was provided for interested persons to respond to the proposal. Five comments were received: Four in support of the proposed rule and one opposed. The commenter in opposition questioned the use of funds for more committee travel and expressed concern that past trips have not increased sales. The commenter is also concerned that the increase would be at the expense of producers. This action increases the assessment obligation imposed on handlers. While some of these additional costs may be passed on to producers, the committee, which is comprised of producers and handlers, unanimously voted to increase the assessment rate. It is expected that the increase in costs would be offset by the benefits derived by the industry, as a whole. Accordingly, no change will be made to the rule as proposed.

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/rules-regulations/moa/small-businesses. Any questions about the compliance guide should be sent to Jeffrey Smutny at the previously mentioned address in the FOR FURTHER INFORMATION CONTACT section.

After consideration of all relevant material presented, including the information and recommendation submitted by the committee and other available information, it is hereby found that this 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 that good cause exists for not postponing the effective date of this rule until 30 days after publication in the Federal Register because handlers are already receiving 2015-16 raisin crop from growers, and the crop year began on August 1, 2015, and the marketing order requires that the assessment rate applies to all assessable raisins received during the 2015-16 and subsequent seasons. Further, handlers are aware of this rule which was recommended at a public meeting. Also, a 30-day comment period was provided for in the proposed rule.

For the reasons set forth in the preamble, 7 CFR part 989 is amended as follows:

In the rule that is the subject of this correction, the Agency revised 7 CFR 1956.101 as intended, but the Agency inadvertently did not make the correct conforming change in 7 CFR 1956.147. To correct this oversight, the Agency is “reserving” 7 CFR 1956.147 in its entirety. This correction has no substantive effect on how debts are settled under this part.

As published, the text that remains in 7 CFR 1956.147 after the March 13, 2015, rule may be misleading and cause confusion as a result of the changes made to 7 CFR 1956.101 in the March 13, 2015, rule.

Accordingly, 7 CFR 1956.147 is corrected by making the following correcting amendment:

Background on Viticultural Areas TTB Authority

Section 105(e) of the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. 205(e), authorizes the Secretary of the Treasury to prescribe regulations for the labeling of wine, distilled spirits, and malt beverages. The FAA Act provides that these regulations should, among other things, prohibit consumer deception and the use of misleading statements on labels and ensure that labels provide the consumer with adequate information as to the identity and quality of the product. The Alcohol and Tobacco Tax and Trade Bureau (TTB) administers the FAA Act pursuant to section 1111(d) of the Homeland Security Act of 2002, codified at 6 U.S.C. 531(d). The Secretary has delegated various authorities through Treasury Department Order 120-01, dated December 10, 2013, to the TTB Administrator to perform the functions and duties in the administration and enforcement of this law.

Part 4 of the TTB regulations (27 CFR part 4) authorizes TTB to establish definitive viticultural areas and regulate the use of their names as appellations of origin on wine labels and in wine advertisements. Part 9 of the TTB regulations (27 CFR part 9) sets forth standards for the preparation and submission of petitions for the establishment or modification of American viticultural areas (AVAs) and lists the approved AVAs.

Section 4.25(e)(1)(i) of the TTB regulations (27 CFR 4.25(e)(1)(i)) defines a viticultural area for American wine as a delimited grape-growing region having distinguishing features, as described in part 9 of the regulations, and a name and a delineated boundary, as established in part 9 of the regulations. These designations allow vintners and consumers to attribute a given quality, reputation, or other characteristic of a wine made from grapes grown in an area to the wine's geographic origin. The establishment of AVAs allows vintners to describe more accurately the origin of their wines to consumers and helps consumers to identify wines they may purchase. Establishment of an AVA is neither an approval nor an endorsement by TTB of the wine produced in that area.

Section 4.25(e)(2) of the TTB regulations (27 CFR 4.25(e)(2)) outlines the procedure for proposing an AVA and provides that any interested party may petition TTB to establish a grape-growing region as an AVA. Section 9.12 of the TTB regulations (27 CFR 9.12) prescribes standards for petitions for the establishment or modification of AVAs. Petitions to establish an AVA must include the following:

• Evidence that the area within the proposed AVA boundary is nationally or locally known by the AVA name specified in the petition;

• An explanation of the basis for defining the boundary of the proposed AVA;

• A narrative description of the features of the proposed AVA affecting viticulture, such as climate, geology, soils, physical features, and elevation, that make the proposed AVA distinctive and distinguish it from adjacent areas outside the proposed AVA boundary;

• The appropriate United States Geological Survey (USGS) map(s) showing the location of the proposed AVA, with the boundary of the proposed AVA clearly drawn thereon; and

• A detailed narrative description of the proposed AVA boundary based on USGS map markings.

TTB received a petition from Martha Cunningham, owner of the 3 Horse Ranch Vineyards, on behalf of the local grape growers and vintners, proposing the establishment of the “Eagle Foothills” AVA in Gem and Ada Counties, Idaho. The proposed AVA is immediately north of the city of Eagle and is approximately 10 miles northwest of the city of Boise. The Eagle Foothills AVA is located entirely within the established Snake River Valley AVA (27 CFR 9.208) and does not overlap with any other existing or proposed AVA. The original proposed name for the AVA was “Willow Creek Idaho.” However, TTB determined that the petition did not sufficiently demonstrate that the region is known by that name. Therefore, the petitioner submitted a request to change the proposed AVA name to “Eagle Foothills.”

The proposed Eagle Foothills AVA contains approximately 49,815 acres, with 9 commercially-producing vineyards covering a total of 67 acres distributed throughout the proposed AVA. The petition states that an additional 4 acres will soon be added to an existing vineyard and that an additional 7 commercial vineyards covering approximately 472 acres are planned within the next few years.

According to the petition, the distinguishing features of the proposed Eagle Foothills AVA are its topography, climate, and soils. The proposed AVA is located within the Unwooded Alkaline Foothills ecoregion of Idaho. This ecoregion is defined as an arid, sparsely populated region of rolling foothills, benches, and alluvial fans underlain by alkaline lake bed deposits. A network of seasonal creeks flowing southwesterly through the proposed AVA have created deep gulches and a rugged terrain that has a variety of slope aspects favorable to the vineyard owners. The elevation within the proposed AVA ranges from 2,490 feet to approximately 3,400 feet, with an average elevation of 2,900 feet. The high elevations enable cold air to drain from the proposed AVA and pool within the lower surrounding elevations, resulting in fewer damaging frosts within the proposed AVA. The cool climate and relatively short growing season are suitable for growing early- to mid-season varieties of grapes such as Chardonnay, Pinot Gris, and Riesling. The proposed AVA contains a variety of soils, but loams, sandy loams, coarse sandy loams, and stony loams are predominant and are notable for their large, irregularly shaped, coarse grains. Due to the grains' irregular shapes, “pockets” of oxygen form in the soil, which promote healthy root growth and allow for rapid water drainage.

Compared with the proposed AVA, the Emmett Valley and Payette River Plain to the north are lower, flatter, and have greater population density than the proposed AVA. Due to the lower elevations, the region to the north has a warmer climate and a longer growing season than the proposed AVA. The soils in the region to the north of the proposed AVA are derived from active flood plain alluvium. These soils have a finer, more uniform texture and greater water-holding capacity than the soils of the proposed Eagle Foothills AVA.

East of the proposed AVA is the mountainous region known as the Boise Front, which has higher elevations. Due to the higher elevations, the region to the east has a shorter growing season and cooler growing season temperatures than the proposed AVA. The soils of the Boise Front are predominantly composed of granite and volcanic materials and lack the sedimentary materials found in the soils of the proposed AVA.

The Boise River Plain is to the south of the proposed AVA, and this region has lower elevations, shallow slope plains, and a longer growing season than the proposed AVA. The soils in this region are similar to the soils north of the proposed AVA, in that they are derived from flood plain alluvium and are finer than the soils within the proposed Eagle Foothills AVA.

Finally, the region to the west is also within the Boise River Plain which, as mentioned previously, has a lower elevation and warmer temperatures, which provide longer growing seasons than are found within the proposed AVA. Furthermore, when compared to the proposed AVA, the soils in the region to the west are fine-grained and the bedrock has a greater depth.

TTB published Notice No. 150 in the Federal Register on April 14, 2015 (80 FR 19908), proposing to establish the Eagle Foothills AVA. In the notice, TTB summarized the evidence from the petition regarding the name, boundary, and distinguishing features for the proposed AVA. The notice also compared the distinguishing features of the proposed AVA to the surrounding areas. For a detailed description of the evidence relating to the name, boundary, and distinguishing features of the proposed AVA, and for a detailed comparison of the distinguishing features of the proposed AVA to the surrounding areas, see Notice No. 150.

In Notice No. 150, TTB solicited comments on the accuracy of the name, boundary, and other required information submitted in support of the petition. In addition, given the proposed Eagle Foothills AVA's location within the existing Snake River Valley AVA, TTB solicited comments on whether the geographic features of the proposed AVA sufficiently differentiate it from the existing Snake River Valley AVA. Finally, TTB requested comments on whether the geographic features of the proposed AVA are so distinguishable from the surrounding Snake River Valley AVA that the proposed Eagle Foothills AVA should no longer be part of the established AVA. The comment period closed on June 15, 2015. TTB received no comments in response to Notice No. 150.

After careful review of the petition, TTB finds that the evidence provided by the petitioner supports the establishment of the Eagle Foothills AVA. Accordingly, under the authority of the FAA Act, section 1111(d) of the Homeland Security Act of 2002, and part 4 of the TTB regulations, TTB establishes the “Eagle Foothills” AVA in Gem and Ada Counties in Idaho, effective 30 days from the publication date of this document.

TTB has also determined that the Eagle Foothills AVA will remain part of the established Snake River Valley AVA. As discussed in Notice No. 150, the proposed Eagle Foothills AVA is located along the eastern edge of the Snake River Valley AVA and shares the same broad characteristics of this AVA, in that both regions are semiarid and have vineyards that are planted on slopes to maximize sunlight exposure and minimize the risk of frost. However, the Eagle Foothills AVA receives several more inches of precipitation per year and has a slightly longer growing season. Additionally, the Snake River Valley AVA contains a large variety of diverse soils, unlike the proposed AVA which has fairly uniform soil characteristics throughout.

See the narrative description of the boundary of the Eagle Foothills AVA in the regulatory text published at the end of this final rule.

The petitioner provided the required maps, and they are listed below in the regulatory text.

Part 4 of the TTB regulations prohibits any label reference on a wine that indicates or implies an origin other than the wine's true place of origin. For a wine to be labeled with an AVA name or with a brand name that includes an AVA name, at least 85 percent of the wine must be derived from grapes grown within the area represented by that name, and the wine must meet the other conditions listed in 27 CFR 4.25(e)(3). If the wine is not eligible for labeling with an AVA name and that name appears in the brand name, then the label is not in compliance and the bottler must change the brand name and obtain approval of a new label. Similarly, if the AVA name appears in another reference on the label in a misleading manner, the bottler would have to obtain approval of a new label. Different rules apply if a wine has a brand name containing an AVA name that was used as a brand name on a label approved before July 7, 1986. See 27 CFR 4.39(i)(2) for details.

With the establishment of this AVA, its name, “Eagle Foothills,” will be recognized as a name of viticultural significance under § 4.39(i)(3) of the TTB regulations (27 CFR 4.39(i)(3)). The text of the regulation clarifies this point. Consequently, wine bottlers using the name “Eagle Foothills” in a brand name, including a trademark, or in another label reference as to the origin of the wine, will have to ensure that the product is eligible to use the AVA name as an appellation of origin.

The establishment of the Eagle Foothills AVA will not affect any existing AVA, and any bottlers using “Snake River Valley” as an appellation of origin or in a brand name for wines made from grapes grown within the Snake River Valley AVA will not be affected by the establishment of this new AVA. The establishment of the Eagle Foothills AVA will allow vintners to use “Eagle Foothills” and “Snake River Valley” as appellations of origin for wines made primarily from grapes grown within the Eagle Foothills AVA if the wines meet the eligibility requirements for the appellation.

TTB certifies that this regulation will not have a significant economic impact on a substantial number of small entities. The regulation imposes no new reporting, recordkeeping, or other administrative requirement. Any benefit derived from the use of an AVA name would be the result of a proprietor's efforts and consumer acceptance of wines from that area. Therefore, no regulatory flexibility analysis is required.

It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866 of September 30, 1993. Therefore, no regulatory assessment is required.

Dominique Christianson of the Regulations and Rulings Division drafted this final rule.

For the reasons discussed in the preamble, TTB amends title 27, chapter I, part 9, Code of Federal Regulations, as follows:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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-2010-0099 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 January 25, 2016. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0099, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

An exemption from the requirement of a tolerance for residues of the Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food commodities when applied pre-harvest and used in accordance with good agricultural practices was established and published in the Federal Register of February 15, 2012 (77 FR 8731) (FRL-9337-3). In the Federal Register of July 17, 2015 (80 FR 42462) (FRL-9929-13), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 4F8342) by bio-ferm GmbH, Technologiezentrum Tulln, Technopark 1, Tulln, 3430, Austria. The petition requested that 40 CFR 180.1312 be amended by expanding the current exemption to also include food commodities that are treated post-harvest. Therefore an exemption from the requirement of a tolerance for residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food commodities was proposed. The Notice of Filing referenced a summary of the petition prepared by the petitioner bio-ferm GmbH, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing.

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 FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption, 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, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

EPA evaluated the available toxicity and exposure data on Aureobasidium pullulans strains DSM 14940 and DSM 14941 and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. A full explanation of the data upon which EPA relied and its risk assessment based on that data can be found within the October 15, 2015, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) considerations for Aureobasidium pullulans strains DSM 14940 and DSM 14941”. This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941. Therefore, an exemption from the requirement of a tolerance is established for residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food commodities when used in accordance with label directions and good agricultural practices.

An analytical method is not required for enforcement purposes for the reasons contained in the October 15, 2015, document entitled “Federal Food, Drug, and Cosmetic Act (FFDCA) considerations for Aureobasidium pullulans strains DSM 14940 and DSM 14941” and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

This action establishes a tolerance exemption under FFDCA section 408(d) in response to a petition submitted to EPA. 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), such as the tolerance exemption in this action, 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 action 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 FFDCA section 408(n)(4). As such, EPA 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, EPA 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

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

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0640 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 January 25, 2016. 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 (excluding any Confidential Business Information (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 the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2014-0640, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

In the Federal Register of February 11, 2015, (80 FR 7559) (FRL-9921-94), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP) 4F8305 by BASF Corporation, 26 Davis Drive, P.O. Box 13528, Research Triangle Park, NC 27709-3528. The petition requested that 40 CFR 180.649 be amended by establishing tolerances for residues of the herbicide, saflufenacil (2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl) amino]sulfonyl]benzamide) and its metabolites, in or on pomegranate at 0.03 parts per million (ppm). That document referenced a summary of the petition prepared by BASF Corporation, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish 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. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 saflufenacil, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with saflufenacil follows.

EPA has evaluated the available toxicity data and considered its 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.

The effects observed following repeated oral exposures to saflufenacil are consistent with the proposed mode of toxicity involving inhibition of protoporphyrinogen oxidase (PPO) in mammals, resulting in disruption of heme biosynthesis. Toxicological effects from subchronic and chronic toxicity studies in rats, mice and dogs consisted of decreased hematological parameters (RBC, Ht, MCV, MCH, and MCHC) at approximately the same dose level (13-39 mg/kg/day), except in the case of the dog, where the effects were seen at a slightly higher dose (50-100 mg/kg/day). In line with the absorption, distribution, metabolism, and excretion (ADME) findings suggesting that male rats achieve a greater systemic exposure than females, males were the most sensitive sex in mice and rats, with LOAELs approximately 3-4X lower than their female counterparts. The hematological effects resulting from oral exposures to saflufenacil occurred around the same dose level from short- through long-term exposures without increasing in severity. Toxic effects were also seen in the liver (increased organ weight, centrilobular fatty change, lymphoid infiltrate) in mice, the spleen (increased organ weight and extramedullary hematopoiesis) in rats, and in both of these organs (increased iron storage in the liver and extramedullary hematopoiesis in the spleen) in dogs. These effects also occurred around the same dose level from short- through long-term exposures without a progression in severity.

Evidence for increased pre- and/or postnatal susceptibility was noted from the developmental toxicity studies in the rat and rabbit and in the 2-generation reproduction study in the rat. Decreased fetal body weights and increased skeletal variations occurred at doses (20 mg/kg/day) that were not maternally toxic in the developmental study in rats. Similarly, in rabbits, increased liver porphyrins in fetuses were observed at doses (200 mg/kg/day) that were not maternally toxic. In the 2-generation reproductive toxicity study in rats, there was evidence of increased qualitative susceptibility based on an increased number of stillborn pups, decreased pup viability and lactation indices, decreased pre-weaning body-weight and/or body-weight gain, and changes in hematological parameters at the same dose level as less severe maternal effects consisting of decrements in food intake, body-weight, body-weight gain, and changes in organ weights and hematological parameters indicative of anemia.

In an acute neurotoxicity (ACN) study in rats, a decrease in motor activity was observed on the day of dosing at the limit dose (2,000 mg/kg/day) in males only. However, the finding was not accompanied by any neuropathological changes and was considered a reflection of a mild and transient general systemic toxicity and not a substance-specific neurotoxic effect. In the subchronic neurotoxicity (SCN) study, systemic toxicity (anemia) was seen at 1,000 ppm (66.2 mg/kg/day) and 1,350 ppm (101 mg/kg/day) in males and females, respectively. There was no evidence of neurotoxicity or neuropathology in either the acute or subchronic neurotoxicity study.

In a 28-day dermal toxicity study in rats, saflufenacil did not induce any type of dermal or systemic toxicity up to the limit dose of 1,000 mg/kg bw/day.

Based on the results of acute toxicity studies, saflufenacil was ranked low for acute toxicity via the oral, dermal, and inhalation route of exposure. It was not classified as a dermal irritant or dermal sensitizer.

In a 28-day immunotoxicity study in mice, saflufenacil failed to induce toxicity specific to the immune system at the highest dose tested (i.e., 52 mg/kg bw/day).

Saflufenacil was weakly clastogenic in the in vitro chromosomal aberration assay in V79 cells in the presence of S9 activation; however, the response was not evident in the absence of S9 activation. It was neither mutagenic in bacterial cells nor clastogenic in rodents in vivo. Carcinogenicity studies in rats and mice showed no evidence of increased incidence of tumors at the tested doses. Saflufenacil is classified as “not likely carcinogenic to humans.”

Specific information on the studies received and the nature of the adverse effects caused by saflufenacil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document Saflufenacil. “Human Health Risk Assessment in Support of Tolerances for Residues in/on Pomegranate” pgs. 26-30 in docket ID number EPA-HQ-OPP-2014-0640.

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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

A summary of the toxicological endpoints for saflufenacil used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to saflufenacil, EPA considered exposure under the petitioned-for tolerances as well as all existing saflufenacil tolerances in 40 CFR 180.649. EPA assessed dietary exposures from saflufenacil in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

Such effects were identified for saflufenacil. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA; 2003-2008). As to residue levels in food, EPA used an unrefined approach by assuming that 100% of the crop is treated and that residues are present at the tolerance-level or at tolerance-levels adjusted to account for the residues of concern for risk assessment for all foods. EPA also used default processing factors using the Dietary Exposure Evaluation Model (DEEM) 7.8.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the same conservative assumptions that were used for the acute dietary assessment noted above.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that saflufenacil does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv. Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for saflufenacil. Tolerance-level residues and/or 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening-level water exposure models in the dietary exposure analysis and risk assessment for saflufenacil in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of saflufenacil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.

Based on the Tier 1 Rice Model and Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of saflufenacil for acute exposures are estimated to be 133 parts per billion (ppb) for surface water and 69.2 ppb for ground water.

The EDWCs for chronic exposures for non-cancer assessments are estimated to be 120 ppb for surface water and 51.5 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 133 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 120 ppb was used to assess the contribution to drinking water.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Saflufenacil is not registered for any specific use patterns that would result in residential exposure.

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 saflufenacil to share a common mechanism of toxicity with any other substances, and saflufenacil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that saflufenacil does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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. As discussed in III.A., there is evidence of increased pre- and/or postnatal susceptibility in the developmental toxicity studies in the rat and rabbit and in the 2-generation reproduction study in the rat. The concern for increased susceptibility following prenatal or postnatal exposure is low because clear NOAELs/LOAELs were established for the developmental effects seen in rats and rabbits as well as for the offspring effects seen in the 2-generation reproductive toxicity study. Further, the dose-response relationship for the effects of concern are also well characterized and being used for assessing risks. The point of departure for risk assessments would be protective of the developmental and offspring effects.

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

i. The toxicity database for saflufenacil is complete.

ii. There was no evidence of neurotoxicity or neuropathology in the acute and subchronic neurotoxicity study. The decrease in motor activity observed in the acute neurotoxicity study on the day of dosing at the limit dose (2,000 mg/kg/day) in males is considered a reflection of a mild and transient general systemic toxicity and not a substance-specific neurotoxic effect. No neurotoxic effects were seen in the sub-chronic neurotoxicity study.

iii. The concern for increased susceptibility following prenatal or postnatal exposure is low because clear NOAELs/LOAELs were established for the developmental effects seen in rats and rabbits as well as for the offspring effects seen in the 2-generation reproductive toxicity study. Further, the dose-response relationship for the effects of concern are also well characterized and being used for assessing risks. The POD for risk assessments would be protective of the developmental and offspring effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to saflufenacil in drinking water. These assessments will not underestimate the exposure and risks posed by saflufenacil.

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. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to saflufenacil will occupy less than 1% of the aPAD for all infants (<1-year old), the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to saflufenacil from food and water will utilize 20% of the cPAD for all infants (<1-year old) the population group receiving the greatest exposure. There are no residential uses for saflufenacil.

3. Short-term and intermediate-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). Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water. Since there are no registered or proposed residential uses for saflufenacil that would result in short or intermediate-term residential exposures, and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating short and intermediate-term risk for saflufenacil.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, saflufenacil is not expected to pose a cancer risk to humans.

5. 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 saflufenacil residues.

Adequate enforcement methodology (liquid chromatography/mass spectroscopy/mass spectroscopy (LC/MS/MS) Method D0603/02) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected].

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint 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 saflufenacil on pomegranate. Therefore, harmonization of MRLs and U.S. tolerances is not an issue at this time.

EPA received two comments to the docket, EPA-HQ-OPP-2014-0640; however, only one of these public submissions was in response to the Notice of Filing for PP# 4F8305, while the remaining comment pertained to an unrelated petition in the Federal Register notice. For PP# 4F8305, the commenter stated that they are in support of actions to set tolerance levels for pesticides on the food we eat and that we are taking a step in the right direction by making it safer for human consumption by placing more regulations on pesticide chemicals.

EPA agrees with the commenter and will continue to regulate pesticides under the legal framework provided by the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA) and Section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA), which allows EPA to assess the risk of pesticides and set tolerance levels for those pesticides on food commodities as deemed necessary to protect human health while still providing tools for growers so that they can meet the ever-growing food demands of this country and others.

Therefore, tolerances are established for residues of saflufenacil, (2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino]sulfonyl]benzamide) and its metabolites, in or on pomegranate at 0.03 ppm.

This action establishes a tolerance under FFDCA section 408(d) 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 action has been exempted from review under Executive Order 12866, this action 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 action 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 FFDCA section 408(d), 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 action 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 FFDCA section 408(n)(4). 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 action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

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 (NTTAA) (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, 40 CFR chapter I is amended as follows:

I. Public Participation

In a notice of proposed rulemaking published on August 13, 2015 (80 FR 48473), HHS invited interested persons or organizations to submit written views, recommendations, and data regarding the removal of part 80. We received no comments on this rule.

HHS promulgated part 80 of title 42 to facilitate Section 21(a)(1) of the Occupational Safety and Health (OSH) Act of 1970 (29 U.S.C. 670(a)(1)), which authorizes the Director of NIOSH to conduct educational programs to provide an adequate supply of qualified personnel to carry out the purposes of the OSH Act. Part 80 established tuition fees for such training, as authorized by 31 U.S.C. 483a (31 U.S.C. 9701, as revised by Public Law 97-258, September 13, 1982), which permits agencies to “prescribe regulations establishing the charge for service or thing of value provided by the agency.” In accordance with section 6 of Executive Order 13563, HHS conducted a retrospective analysis of its existing rules, determined Part 80 to be obsolete, and is hereby removing Part 80 from Title 42.

The provisions in Part 80 establish the NIOSH policies with respect to the charging of fees for direct training in occupational safety and health. Because NIOSH no longer offers direct training programs, these provisions are no longer needed. Removing Part 80 from Title 42 will have no effect on NIOSH procedures or practices, including the NIOSH funding of the Education and Research Centers for Occupational Safety and Health. This action is being done in accordance with Executive Order 13563, section 6, which requires that Federal agencies conduct retrospective analyses of existing rules. In conducting the analysis, HHS discovered that the Part 80 provisions were outdated.

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

This final rule has been determined not to be a “significant regulatory action” under section 3(f) of E.O. 12866. With this action, HHS is removing part 80 from title 42. Because this final rule is entirely administrative and does not affect the economic impact, cost, or policies of any activities authorized by title 42, HHS has not prepared an economic analysis and the Office of Management and Budget (OMB) has not reviewed this rulemaking.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., requires each agency to consider the potential impact of its regulations on small entities including small businesses, small governmental units, and small not-for-profit organizations. Because no substantive changes will be made to 42 CFR part 80 as a result of this action, HHS certifies that this rule has “no significant economic impact upon a substantial number of small entities” within the meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.).

The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on, and to obtain OMB approval of, any regulation that requires 10 or more people to report information to the agency or to keep certain records. This rule does not contain any information collection requirements; thus, HHS has determined that the PRA does not apply to this rule.

As required by Congress under the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS reported the promulgation of this rule to Congress prior to its effective date.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 et seq.) directs agencies to assess the effects of Federal regulatory actions on State, local, and Tribal governments, and the private sector “other than to the extent that such regulations incorporate requirements specifically set forth in law.” For purposes of the Unfunded Mandates Reform Act, this final rule does not include any Federal mandate that may result in increased annual expenditures in excess of $100 million by State, local or Tribal governments in the aggregate, or by the private sector.

This final rule has been drafted and reviewed in accordance with Executive Order 12988, “Civil Justice Reform,” and will not unduly burden the Federal court system. This rule has been reviewed carefully to eliminate drafting errors and ambiguities.

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

In accordance with Executive Order 13045, HHS has evaluated the environmental health and safety effects of this final rule on children. HHS has determined that the rule would have no environmental health and safety effect on children.

In accordance with Executive Order 13211, HHS has evaluated the effects of this final rule on energy supply, distribution or use, and has determined that the rule will not have a significant adverse effect.

Under Public Law 111-274 (October 13, 2010), executive Departments and Agencies are required to use plain language in documents that explain to the public how to comply with a requirement the Federal Government administers or enforces. HHS has attempted to use plain language in promulgating the final rule consistent with the Federal Plain Writing Act guidelines.

For the reasons discussed in the preamble and under the authorities 29 U.S.C. 671, 31 U.S.C. 9701, and 42 U.S.C. 216(b), the Department of Health and Human Services amends 42 CFR chapter I by removing part 80.

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

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

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

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

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

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

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

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

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

Accordingly, 44 CFR part 64 is amended as follows:

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

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

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

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

Regulatory Flexibility Act. The Administrator has determined that this rule is exempt from the requirements of the Regulatory Flexibility Act because the National Flood Insurance Act of 1968, as amended, Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed no longer comply with the statutory requirements, and after the effective date, flood insurance will no longer be available in the communities unless remedial action takes place.

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

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

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

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

Accordingly, 44 CFR part 64 is amended as follows:

This document announces that, on November 9, 2015, OMB approved the revised information collection requirements contained in the Commission's Report and Order, FCC 15-47, published at 80 FR 36163, June 23, 2015. The OMB Control Number is 3060-1211. The Commission publishes this document as an announcement of the effective date of the requirements. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 1-C823, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-1211 in your correspondence. The Commission will also accept your comments via email at [email protected].

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to [email protected] or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on November 9, 2015, for the revised information collection requirements contained in the Commission's rules at 47 CFR 96.17; 96.21; 96.23; 96.33; 96.35; 96.39; 96.41; 96.43; 96.45; 96.51; 96.57; 96.59; 96.61; 96.63; and 96.67. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Numbers is 3060-1211.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1211.

OMB Approval Date: November 9, 2015.

OMB Expiration Date: November 30, 2018.

Title: Sections 96.17; 96.21; 96.23; 96.33; 96.35; 96.39; 96.41; 96.43; 96.45; 96.51; 96.57; 96.59; 96.61; 96.63; and 96.67, Commercial Operations in the 3550-3650 MHz Band.

Form Number: Not applicable.

Type of Review: New information collection.

Respondents: Business or other for-profit entities, Not for profit institutions and State, Local or Tribal Governments.

Number of Respondents and Responses: 110,782 respondents; 136,432 responses.

Estimated Time per Response: 0-.5 hours.

Frequency of Response: One-time and on occasion reporting requirements; other reporting requirements—as needed basis for the equipment safety certifications, and consistently (likely daily) responses automated via the device.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this collection is contained in 47 U.S.C. 151, 152, 154(i), 154(j), 155(c), 302(a), 303, 304, 307(e), and 316.

Total Annual Burden: 37,977 hours.

Annual Cost Burden: $7,318,100.

Privacy Act Impact Assessment: No impact(s).

Nature and Extent of Confidentiality: There is no need for confidentiality with this collection of information. The information to be collected will be made available for public inspection. Applicants may request materials or information submitted to the Commission be given confidential treatment under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: The Federal Communications Commission (Commission) received approval for new OMB Control No. 3060-1211 from the Office of Management and Budget (OMB). The purpose of this proposal was to obtain OMB approval of rules applicable to 3550-3700 MHz (3.5 GHz) users and licensees and applicants for database administrators, as adopted by the Commission in a Report and Order (Report and Order) on April 17, 2015 (WT Docket No. 12-354; FCC 15-47). By the Report and Order, the Commission creates additional capacity for wireless broadband by adopting a new approach to spectrum management to facilitate spectrum sharing between commercial and federal users and among multiple tiers of commercial users. The order creates a Spectrum Access System (SAS), an online database that will manage and coordinate frequency use in the band through registration and other technical information. The SAS will use the information to assign frequencies, manage interference, and authorize spectrum use. The Commission will use the information to authorize the SAS Administrator(s) and ESC operator(s).

I. Background

NASA published a proposed rule in the Federal Register at 80 FR 48284 on August 12, 2015, to revise both the prescription for and text of the clause at 1852.223-70, which was retitled from “Safety and Health” to “Safety and Health Measures and Mishap Reporting” to emphasize the purpose of the clause—requiring contractors working at Federal facilities to have measures in place to protect the safety of their workers, other individuals working at the facility, and the public. To reduce the burden on contractors, the clause prescription was revised to require it in solicitations and contracts above the simplified action threshold and to require it only for contracts involving performance at a Federal facility. The applicability to subcontracts was also revised to apply to subcontracts above the simplified acquisition threshold where performance is at a Federal facility.

Paragraph (b) of the clause lists safety and occupational health measures, recognized by the Office of Safety and Health Administration and industry, as standards for both identifying workplace hazards and for developing a plan for prevention and control of those hazards. These measures include maintaining an effective worksite safety and health program with organized and systematic methods to—

1. Comply with Federal, State, and local safety and occupational health laws and with the safety and occupational health requirements of the contract;

2. Describe and assign the responsibilities of managers, supervisors, and employees;

3. Inspect regularly for and identify, evaluate, prevent, and control hazards;

4. Orient and train employees to eliminate or avoid hazards; and

5. Periodically review the program's effectiveness. Additionally, paragraph (b) added text concerning authorized Government representatives' rights to have access to and to examine the work site and related records under the contract in order to determine the adequacy of the Contractor's safety and occupational health measures. Paragraph (d) refers to NASA Procedural Requirement (NPR) 8621.1, Mishap and Close Call Reporting, Investigating, and Recordkeeping, which contains a listing and description of the types of mishaps (types A, B, C, or D) or close calls the contractor must report to the contracting officer. Paragraph (e) requires contractors to cooperate with any Government-authorized investigation by providing access to their employees and relevant information in their possession regarding the mishap or close call. Paragraph (f) states the Contracting Officer may notify the Contractor of any noncompliance with the health and safety requirements of the contract and require corrective action. If the contractor fails or refuses to take prompt corrective action, the Contracting Officer may—

(1) Invoke the stop-work order clause;

(2) Require the Contractor to remove and replace Contractor or subcontractor personnel who fail to comply with or violate applicable requirements;

(3) Record the Contractor's failure to comply in the appropriate databases of past performance; and

(4) Consider the Contractor's failure to comply in any responsibility determination or evaluation of past performance.

Paragraph (g) requires the prime contractor to include the clause in subcontracts over the simplified acquisition threshold when the work will be conducted completely or partly on federally-controlled facilities.

No public comments were received in response to the proposed rule. However, during internal deliberations a couple of minor changes were made. Section 1801.106(1) was revised to add new OMB control number 2700-1060, which was assigned for reporting requirements at NFS 1852.223-70. Additionally, paragraph (f)(1) of 1852.223-70 was revised to change the phrase “the Contracting Officer shall” to “the Contracting Officer will” and to remove the term “any necessary.” Paragraph (f) (2) was revised to remove “in addition to other remedies available to the Government” and add “the contracting officer may” with a list of four actions, previously listed in the proposed rule, enumerated and rephrased to clearly list the action to be taken: “invoke,” “require,” “record,” and “consider.” No other revisions were made to the proposed rule.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

NASA has prepared a Final Regulatory Flexibility Analysis (FRFA) consistent with the Regulatory Flexibility Act, 5 U.S.C. 601, et se., and is summarized as follows:

This rule revises NFS clause 1852.223-70 to reduce burden on contractors by (1) changing the applicability of the clause to only contracts over the simplified acquisition threshold and to only those performed on Federal facilities, and (2) by removing reporting requirements relating to mishap investigations and health and safety plans. The clause also provides guidance on specific safety and health measures the contractor must take when working on a Federal facility, and the remedies the Government may take for failure to maintain an effective safety and health program.

No comments were received on the initial regulatory flexibility analysis from small business concerns or other interested parties.

This rule will apply to small entities performing NASA contracts with an estimated value over the simplified acquisition threshold on Federal Facilities. The System for Award Management (SAM) data shows approximately 154 firms received contracts to which this clause will apply. Of those 154 firms, 84 were small businesses.

Two reporting requirements are contained in the rule. One is to notify the contracting officer of mishaps (types A, B, C, or D) or close calls as described in NASA Procedural Requirement (NPR) 8621.1, Mishap and Close Call Reporting, Investigating, and Recordkeeping. The other is to provide a quarterly report on the number of mishaps, specifying lost time frequency rate, number of lost time injuries, exposure, and accident/incident dollar losses. This information is collected so that NASA can analyze mishap data to look for mishap trends and determine ways to improve the safety of its workforce and high-value assets and reduce the risk to its missions. This mishap information would be initially collected by a company manager or supervisor. It may be reviewed by the firm's official responsible for safety, usually an occupational health and safety. Lost time frequency rate, number of lost time injuries, exposure, and accident/incident dollar losses reports would be prepared by a safety official.

The revisions to NFS clause 1852.223-70 are designed to reduce burden on contractors by reducing the applicability of the clause and reducing the paperwork burden. The information requested in the clause is essential to the NASA health and safety program. Further and differing compliance alternatives or reporting requirements or timetables for small entities are not feasible. Having an effective safety program is crucial to all businesses as it reduces injuries, lost time, property damage and creates a more safe and effective workplace for employees.

The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35). OMB has cleared this information collection requirement under OMB Control Number 2700-0160, titled: Safety and Health Measures and Mishap Reporting.

Accordingly, 48 CFR parts 1801, 1823 and 1852 are amended as follows:

I. Background

NASA published an interim rule in the Federal Register at 80 FR 51957 on August 27, 2015, to amend the NASA Federal Acquisition Regulation Supplement (NFS) to increase the NASA capitalization threshold from $100,000 to $500,000.

There were no public comments submitted in response to the interim rule. The interim rule has been converted to a final rule, without change.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

NASA does not expect this final rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et se. A final regulatory flexibility analysis has been performed and is summarized as follows:

The increase in the NASA capitalization threshold is expected to benefit NASA contractors by reducing the administrative burden associated with financial reporting of NASA property in the custody of contractors. The legal basis for this rule is 51 U.S.C. 20113(a).

The requirements under this rule will apply to any contract award (including contracts for supplies, services, construction, and major systems) that requires the use of Government property by contractors. According to NASA Property Records in FY 2014 there were 568 contracts that required reporting of Government property by NASA contractors. Of the 568 contracts, it is estimated that approximately 20% or 114 contracts were small businesses.

The rule does not duplicate, overlap, or conflict with any other Federal rules. No alternatives were identified that would meet the objectives of the rule.

The rule contains information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35; however, these changes to the NFS do not impose additional information collection requirements to the paperwork burden previously approved under OMB Control Number 2700-0017, entitled NASA Property In the Custody of Contractors and OMB Control No. 9000-0075, entitled Government Property.