Federal Register Vol. 80, No.114,

The information presented in this preamble is organized as follows:

USDA is amending 7 CFR part 3201 to incorporate statutory changes to section 9002 of the Farm Security and Rural Investment Act made by enactment of the Agricultural Act of 2014 on February 7, 2014.

USDA is amending 7 CFR 3201.2 by revising one definition and adding two new definitions for terms that are used in the Guidelines as a result of revisions to section 9002 made by the 2014 Farm Bill. USDA is revising the definition of “biobased product” to state that the term includes forest products that meet biobased content requirements, notwithstanding the market share the product holds, the age of the product, or whether the market for the product is new or emerging.

USDA is adding definitions for the terms “forest product” and “renewable chemical.” These terms were defined in the text of the 2014 Farm Bill and USDA is proposing to add them verbatim to the BioPreferred Program Guidelines.

USDA is also deleting the current definition of “forestry materials” from section 3201.2. USDA is deleting the existing definition of the term “forestry materials” because the newly defined term “forest product” is more appropriate and, thus, will generally replace the existing term.

USDA is also adding a new paragraph (b)(1)(iv) to section 3201.4 to require federal agencies to report the quantities and types of biobased products purchased. This new paragraph responds to specific language included in the 2014 Farm Bill and is intended to provide a means by which the effectiveness of the BioPreferred Program can be measured.

USDA is also adding a new paragraph (b)(4) to section 3201.4 “Procurement programs.” This new paragraph adds the 2014 Farm Bill requirement that federal procuring agencies establish a targeted biobased-only procurement requirement under which the procuring agency must issue a certain number of biobased-only contracts when the agency is purchasing products, or purchasing services that include the use of products, that are included in a biobased product category designated by the Secretary.

USDA is also adding paragraphs to section 3201.5 “Category designation” to expand the description of the procedures and considerations for designating product categories, including those product categories that were excluded from the BioPreferred Program under the previous mature market products exclusion. The Conference Report on the 2014 Farm Bill states: “It is the Managers' intention that all products in the program use innovative approaches in the growing, harvesting, sourcing, procuring, processing, manufacturing, or application of the biobased product.” USDA is, therefore, incorporating criteria to be used when evaluating whether biobased products meet the requirement to use “innovative approaches.”

The Guidelines for Designating Biobased Products for Federal Procurement (the Guidelines) are established under the authority of section 9002 of the Farm Security and Rural Investment Act of 2002 (the 2002 Farm Bill), as amended by the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill), and further amended by the Agricultural Act of 2014 (the 2014 Farm Bill), 7 U.S.C. 8102. (Section 9002 of the 2002 Farm Bill, as amended by the 2008 and the 2014 Farm Bills, is referred to in this document as “section 9002”).

As originally enacted, section 9002 provides for the preferred procurement of biobased products by federal agencies. USDA proposed the Guidelines for implementing this preferred procurement program on December 19, 2003 (68 FR 70730-70746). The Guidelines were promulgated on January 11, 2005 (70 FR 1792), and are contained in 7 CFR part 3201, “Guidelines for Designating Biobased Products for Federal Procurement.”

The Guidelines identify various procedures federal agencies are required to follow in implementing the requirements of section 9002. They were modeled in part on the “Comprehensive Procurement Guidelines for Products Containing Recovered Materials” (40 CFR part 247), which the Environmental Protection Agency (EPA) issued pursuant to the Resource Conservation Recovery Act (“RCRA”), 40 U.S.C. 6962.

On June 18, 2008, the 2008 Farm Bill was signed into law. Section 9001 of the 2008 Farm Bill included several provisions that amended the provisions of section 9002. USDA subsequently amended the Guidelines to incorporate those provisions of the 2008 Farm Bill (79 FR 44641).

The purpose of these amendments is to further revise the Guidelines to incorporate additional changes to section 9002 that were included in the 2014 Farm Bill. These revisions to the Guidelines will not affect products that have already been designated for federal procurement preference. Any changes necessary to the existing designation status of products will be established by future rule-makings.

As a result of public comments received on the proposed amendments to the Guidelines, USDA has made changes in finalizing the amendments. These changes are summarized in the remainder of this section. A summary of each comment received, USDA's response to the comment or group of related comments, and the rationale for any change made in the final rule is presented in section V.

USDA is finalizing the proposed definitions with no changes.

This section has been finalized as proposed.

In the final rule, USDA added a sentence at 3201.5(b)(2) to clarify that evidence of an innovative approach will not be restricted to only those innovative criteria listed in the Guidelines and that consideration of other evidence will be on a case by case basis.

USDA also revised the proposed language in paragraph (b)(2)(i) and (ii) to add the word “biobased” to the description of products or materials that qualify under the first two criteria and also added a paragraph (b)(2)(i)(C) stating that products meet the criteria if the biobased content of the product or material makes its composition different from products or material used for the same historical uses or applications.

This section has been finalized as proposed.

USDA solicited comments on the proposed amendments for 60 days ending on December 26, 2014. USDA received ten comments by that date. One of the comments was from an individual citizen, five were from industry trade groups, one was from a biobased product manufacturer, one was from an academic institution, and two were from federal agencies. The comments are presented below, along with USDA's responses, and are grouped by the Code of Federal Regulation (CFR) section numbers to which they apply.

Comment: Several commenters were supportive of USDA's efforts to include innovative forestry products in the BioPreferred Program and to encourage consumers to use biobased products. One commenter stated that this inclusion will “promote the use of sustainable materials,” enhance rural and national economic development, and “broaden the range of products included in the definition of “forest products” and “renewable chemicals.” ” Another commenter stated generally that the BioPreferred Program and its proposed changes are defined well.

Response: USDA appreciates the support of the commenters.

Comment: One commenter agreed with USDA's proposed definitions for “Biobased product” and “Forest product.” Another commenter stated that “biobased-only contracts” should be defined in the program Guidelines and provided a possible definition.

Response: USDA thanks the commenters for their input. Regarding the definition of “biobased-only contracts,” USDA's Office of Procurement and Property Management (OPPM) will take the issue to the Interagency Sustainable Acquisition and Materials Management Practices Workgroup (SAMM). USDA OPPM, as part of the SAMM, will work with other agencies to determine whether a definition of biobased-only contracts is needed.

Comment: One commenter stated that the definition of “Biobased product” should be modified to include renewable chemicals. The commenter stated that renewable chemicals are already included within the existing statutory and regulatory definition, and proposed that the regulatory definition needs to change to add “renewable chemical” so that the definition includes the words “intermediate ingredient, renewable chemical, or feedstock.”

Response: USDA's believes that when definitions of key BioPreferred Program terms are provided in the Farm Bill language authorizing the Program, those definitions should be used without changes. The proposed definition of “biobased product” is taken verbatim from Section 9001 of the 2014 Farm Bill. USDA agrees with the commenter that renewable chemicals are an important segment of biobased products and is adding a stand-alone definition of “renewable chemical” to the Guidelines to clarify the inclusion of these products in the BioPreferred Program. The definition of “biobased product” has not been revised, however, and is being finalized as proposed.

Comment: Three commenters stated that USDA should provide more guidance for federal agencies on how to establish the proposed targeted biobased-only procurement requirement and that USDA should specify what information this requirement needs to include. Two of the commenters stated that more guidance from USDA and clearer definition of “Biobased Procurement” would limit “significant differences in implementation,” “inconsistencies in the results of interagency assessment,” and “green washing.”

One commenter asked USDA to consider several questions, such as how it differs from other procurement programs, if it is only defined by having FAR Clause 52.223-1 or 52.223-2 in a contract, if buying a product with a “Biobased symbol” on GSA Advantage is enough, and if it excludes “other sustainability programs such as recycling or energy efficiency.” This commenter also asked for more details on “applicability, data sources, standard data collection methods and consistent analysis of data collected.”

Another commenter recommended that USDA work closely with the Sustainable Acquisition and Materials Management Practices Workgroup to provide guidance to federal agencies and their contractors on fulfilling the new reporting requirement. The commenter stated that this guidance should be “implemented via a policy directive from the Office of Management and Budget/OFPP [Office of Federal Procurement Policy]” such that overlapping reporting requirements and the reporting burden on federal agencies and their contractors are reduced.

Response: USDA appreciates the comments provided by these commenters and agrees with the commenters that communication, coordination, and guidance will be needed to fully implement the biobased-only contracts requirement as well as the collection and reporting of data regarding biobased purchases. While USDA is committed to working with federal agencies to develop and implement procedures for complying with the requirements of the 2014 Farm Bill and the BioPreferred Program, those efforts will be separate from the current efforts to finalize the amendments to the Program Guidelines. USDA OPPM will take this 2014 Farm Bill requirement for biobased-only contracts to the interagency Sustainable Acquisition and Materials Management Practices (SAMM) Workgroup. OPPM, as part of the SAMM, will work with other agencies to develop guidance. Specific questions regarding how the procurement programs should work will be addressed with Workgroup members rather than in the context of these Guideline amendments.

Comment: One commenter noted that this new reporting requirement creates an additional burden on federal agencies and their contractors because there is not an electronic means of effectively documenting this information at “the individual product level,” specifying that the Federal Procurement Data System is not designed to do so.

Another commenter stated that USDA should decide which data sources to use for collecting the annual biobased procurement results: “Federal Procurement Data System (FPDS), SAMM.gov, or General Services Administration and Defense Logistics Agency.” In addition, the commenter indicated that USDA should issue a standard method for how the data will be collected and analyzed and that USDA should conduct the data review via a third-party.

A third commenter stated that for the proposed reporting requirement to be successful, it should be “codified in the Federal Acquisition Regulation and a specific reporting portal (such as the Federal Procurement Data System—Next Generation or the System for Award Management [SAM]) should be identified for agencies” to report the data. This commenter urged USDA to “take additional steps” to make sure that federal agencies fulfill the reporting requirement. The commenter suggested implementing a new feature in SAM that would allow federal agencies to report quantities and types of biobased products that they purchased, because there is already a FAR clause in SAM that requires prime contractors to report product types and dollar values of biobased products that are purchased annually.

Response: USDA appreciates the comments and recommendations offered by the commenters on the recordkeeping and reporting requirements. USDA agrees with the commenters that communication, coordination, and guidance will be needed to fully implement the requirements for the collection and reporting of data regarding biobased purchases. Federal government-wide data on biobased product purchases are entered into the System for Award Management (SAM) by Contractors entering data into the BioPreferred portal. This is the automated procurement system that has officially been endorsed by the Chief Acquisition Officers Council, OFPP and the federal government agencies. USDA OPPM is using it to fulfill this requirement. Thus, while USDA is committed to working with federal agencies to develop and implement procedures for complying with the requirements of the 2014 Farm Bill and the BioPreferred Program, those efforts will be separate from the current efforts to finalize the amendments to the Program Guidelines.

Comment: Two commenters provided feedback on what reporting data federal agencies should provide to USDA regarding their annual biobased-only purchases. One commenter recommended that USDA should first establish a baseline for the rate of biobased procurement for federal agencies and then examine this rate after each year. The same commenter stated that after determining this baseline, USDA should work with agencies to set an annual percentage growth rate goal. Another commenter stated that the reporting requirement should specify biobased procurement quantities in “dollar values.”

Response: As discussed in the response to the previous comment, USDA appreciates the input from the commenters but does not believe that it is appropriate to make any revisions to the proposed amendments to the Guidelines. Federal government-wide data on biobased product purchases are entered into the System for Award Management (SAM) by Contractors entering data into the BioPreferred portal. This is the automated procurement system that has officially been endorsed by the Chief Acquisition Officers Council, OFPP and the federal government agencies. USDA OPPM is using it to fulfill this requirement. There will be an amendment to the FAR requesting that FAR Clause 52.223-2 be revised to add quantities. As presently written, it requires the Contractor to report on product types and dollars to the SAM. USDA OPPM will seek to amend it to add quantities.

Comment: Three commenters requested that USDA offer more details on how federal agencies should establish a set number of biobased-only contracts under this proposed requirement. One commenter inquired whether the goal for federal agencies to meet is a set number of contracts, a certain percentage of contracts with specific FAR clauses, or a certain value based on a total agency spend threshold. This commenter asked if specific service contracts should be targeted, as well. Another commenter suggested that instead of stating in proposed § 3201.4(b)(4) that a procuring agency should issue “a certain number of biobased-only contracts,” that the proposed rule should state that the agency should issue “a minimum of 20” biobased contracts “annually, unless a lower or higher number is justified by market research on the availability of products.” The same commenter suggested adding the following sentence at the end of the proposed rule § 3201.4(b)(4), “Each procuring agency shall report the number of biobased-only contracts issued annually and the types and dollar values of biobased products purchased directly under these contracts or used by contractors in carrying out the services provided under the contracts.” The third commenter advised that federal agencies should select a set amount of the current year's planned contracts to be biobased-only based on the previous year's purchase of products and services. The commenter also stated that, as an option, federal agencies could select the top 10 products based on their previous year's purchase of products and services to be biobased-only.

Response: USDA agrees with the commenters that additional guidance will be needed to fully implement the biobased-only contracts requirement. USDA will take this 2014 Farm Bill requirement for biobased-only contracts to the interagency SAMM Workgroup. USDA, as part of the SAMM, will work with other agencies to develop guidance. While USDA is committed to working with federal agencies to develop and implement procedures for complying with the requirements of the 2014 Farm Bill and the BioPreferred Program, those efforts will be separate from the current efforts to finalize the amendments to the Program Guidelines.

Comment: Three commenters expressed support for USDA for allowing forestry and other traditional biobased products to be eligible for participation in the BioPreferred Program. Of these three commenters, two expressed overall support for the proposed criteria for demonstrating innovative approaches as a means of evaluating all biobased products that may be eligible for participation in the BioPreferred Program. One of the commenters stated that these proposed criteria are “reasonable and provide companies submitting products a clear and consistent manner to demonstrate the innovative nature of their product” and that they also allow manufacturers the ability to demonstrate innovation for products that are not easily categorized in the options that USDA outlined. The other commenter stated that these proposed criteria “will help expand the use of biobased products.” The third commenter pointed out that USDA only requires reviewing information for the proposed criterion in § 3201.5(b)(2)(i) but not for any of the others; thus, the commenter asked what information USDA would review to “implement” the other proposed criteria. This commenter also questioned whether this proposed rule would be applied in a “multi-plant manufacturing scenario”: would it be applied at the product or at the manufacturing plant level, and would one plant's compliance be sufficient for all plants?

Response: USDA thanks the commenters for their support of, and participation in, the BioPreferred Program. In response to the one commenter's questions, the text that was proposed and is being finalized for paragraph (b)(2) identifies the criteria that USDA will use to determine a product's eligibility to participate in the Program. USDA has specified in the text that product manufacturers may be asked to provide documentation to verify their claims that they are meeting any one of the criteria. Submitting an EPD is one of the means available for manufacturers to demonstrate that their biobased products meet the “innovative approach” criteria. Various other types of documentation are also acceptable. In evaluating whether the criteria have been met, USDA will work with manufacturers on a case by case basis to determine the most appropriate documentation. Also, USDA review of information to determine eligibility to participate in the BioPreferred Program is product specific, but is independent of the actual manufacturing plant in which the product is produced. That is, if a manufacturer produces product A in two different locations and the product is otherwise identical, the manufacturer only has to apply for registration of their product once.

Comment: One commenter stated that the proposed rule in § 3201.5(b)(2) is unclear and asked if it should it be read with the current rule in § 3201.5(b)(1) or if it would be “used independently to designate products.” This commenter stated that the 2014 Farm Bill wording “implies the latter,” while the proposed rule “implies the former.” The commenter stated that a “federal preference program” should not endorse products on the grounds that they contain biobased ingredients and that they are “new and different” from the way products were manufactured historically instead of considering whether the products are better for the environment and human health, or perform better than those that are currently available. Additionally, this commenter recommended that USDA apply these proposed criteria in a manner such that federal agencies are not required to choose between a “biobased product that does not meet other federal purchasing requirements such as less-ozone-depleting” and a non-biobased product that meets these requirements within a particular product category when making purchasing decisions. This commenter was also concerned that the proposed criteria § 3201.5(b)(2) would “expand the reach” of the BioPreferred Program “beyond what was originally intended.” The commenter recommended that the proposed criterion for an Environmental Product Declaration (EPD) should merely supplement the product's participation in the BioPreferred Program, instead of being a requirement for it.

Response: The amendments that were proposed and are being finalized by this final rule revise paragraph (b)(2) but do not change existing paragraph (b)(1). Paragraph (b)(1) states that USDA will establish a minimum biobased content for designated product categories and that the product categories will be listed in subpart B of part 3201. While USDA understands the commenter's position regarding consideration of environment and human health impacts, the statutory requirements of the 2002 Farm Bill, as amended in the 2008 and 2014 Farm Bills, mandate that the BioPreferred Program promote and give a preference to the purchase of biobased products. USDA does not have the authority nor the resources to evaluate the life cycle environmental and human health impacts of biobased products compared to those of traditional petroleum based products. USDA does present manufacturer-supplied information regarding the performance of products in cases where the manufacturer provides such information. However, as with life cycle impacts, USDA does not have the statutory authority or the resources to independently investigate the performance of products that participate in the Program.

Comment: One commenter expressed concern that the paragraph in § 3201.5(b)(2) was written specifically for forestry products, which could cause issues for non-forestry ones. Thus, the commenter suggested clarifying the introductory paragraph in § 3201.5(b)(2) by adding the word “biobased” in front of “product” and “products.” The commenter also suggested clarifying § 3201.5(b)(2)(i) and (ii) to read:

Two additional commenters supported USDA in designating intermediate chemical categories according to “functional use” because it “offers transparent linkage to the established finished product categories of the Program, as well as recognizing their functional importance in the BioPreferred value chain.” Each commenter provided the same list of “priority” intermediate chemical categories based upon functional use.

Response: USDA agrees with the commenter that certain edits to the proposed language add clarity to the rule and, thus, will revise the proposed language for the final rule. However, USDA disagrees with the commenter's recommendation to include the statement that the manufacturing and processing criteria should be revised to specifically include processes that “add biobased content.” Many biobased products are made by replacing petroleum-based components of traditional products with biobased components, which could be characterized as adding biobased content, and these products would be covered by criterion (i)(C) in the commenter's edited paragraphs. Thus, there would be no benefit to adding a third item to the manufacturing and processing criterion.

Comment: One commenter provided USDA with two examples of a Type III EPD and noted that the EPD requires a product to meet “Product Category Rules.” The commenter pointed out that this information “may or may not be available and would require time to develop.” The commenter added that the “LCA related data” included in the EPD will assist in comparing products but inquired how federal agencies will use this data. Additionally, the commenter asked if there is an advantage to using this data as one means of defining “biobased purchasing.”

Response: USDA points out that the proposal did not make it a “requirement” that a manufacturer submit an Environmental Product Declaration (EPD) to participate in the BioPreferred Program. Submitting an EPD is one of the means available for manufacturers to demonstrate that their biobased products meet the “innovative approach” criteria. Various other types of documentation are also acceptable. USDA also agrees that not all manufacturers have EPDs for their products and that the completion of an EPD can be time consuming. The purpose of requesting documentation such as, but not limited to, an EPD is to demonstrate that the manufacturer meet Congress' intention that “all products in the program use innovative approaches in the growing, harvesting, sourcing, procuring, processing, manufacturing, or application of the biobased product.” Because not all manufacturers have performed an EPD, USDA does not believe that it would be beneficial to require this type of data in defining “biobased purchases” by federal agencies. USDA's position is that purchases of biobased products that have been accepted into the BioPreferred Program and are, thus, listed in the Program's Biobased product catalog are eligible to be counted as “biobased purchases.”

Comment: One commenter wanted USDA to take into account that a finished wood product may be sourced domestically or globally; thus, the commenter cautioned USDA that the criteria proposed in § 3201.5(b)(2)(iv) do not “inadvertently create a technical barrier to trade” and do not exclude imported wood products that were harvested and exported legally in the U.S. and in their country of origin. This commenter recommended that USDA recognize in the proposed rule that new certification schemes for forestry products develop every year; as such, the commenter encouraged USDA to include “new legality systems,” for example, the Voluntary Partnership Agreements under the European Union's Forest Law Enforcement, Governance and Trade Action Plan as another way to demonstrate innovation. In addition, the commenter advised USDA to be aware that the definitions for “legal, responsible, or certified sources” are not applied such that innovation in forestry management and certification are not considered. The commenter looked forward to “working closely with USDA” to help implement these rules.

Response: USDA agrees with the commenters that the proposed innovative criteria should not be considered as an all-inclusive list. USDA recognizes that sustainability advances are occurring worldwide and does not intend that new and valid certifications be excluded from consideration by the BioPreferred Program. In the final rule, USDA will clarify that evidence of an innovative approach will not be restricted to only those innovative criteria listed in the Guidelines and that consideration of other evidence will be on a case-by-case basis.

No comments were received on the revisions proposed for this section.

Executive Orders 13563 and 12866 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the final rule was not reviewed by the Office of Management and Budget.

Today's final rule amends the BioPreferred Program Guidelines to establish the regulatory framework for the designation of product categories that were previously excluded from the federal procurement preference because they were mature market products. The designation of such products is specifically required under the Agricultural Act of 2014, which states that the Guidelines shall: “(vi) Promote biobased products, including forest products, that apply an innovative approach to growing, harvesting, sourcing, procuring, processing, manufacturing, or application of biobased products regardless of the date of entry into the marketplace.”

This rule advances the objectives of the BioPreferred Program, as envisioned by Congress in the 2002, 2008 and 2014 Farm Bills, by expanding the scope of products that may be considered for federal procurement preference. The entry into the BioPreferred Program of biobased products that were previously considered to be mature market products will open a new federal market for biobased products that are designated by USDA and also provides newly developed biobased products to be publicized via the BioPreferred Web site. Thus, the rule is expected to increase demand for these products once designated, which, in turn, is expected to increase demand for those agricultural products that can serve as ingredients and feedstocks. This federal procurement preference will thus yield private benefits for businesses producing these ingredients and feedstocks.

Simultaneously, this action could reduce demand for products that do not receive federal procurement preference designation. Producers of biobased products, including intermediate ingredients and feedstocks, that are not so designated or producers of non-biobased products could face a loss of market share within federal procurement.

Manufacturers of biobased products will incur the actual costs of developing the biobased products as well as the costs to gather and submit the biobased product information for the BioPreferred Web site. The costs of developing and marketing new products are, in this case, a voluntary expense if manufacturers choose to pursue a share of the biobased product market.

Although this rule amends or establishes procedures for designating qualifying biobased product categories, no product categories are being designated today. The actual designation of biobased product categories under this program will be accomplished through future rulemaking actions and the effect of those rulemakings on the economy will be addressed at that time.

The RFA, 5 U.S.C. 601-602, generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

Although the BioPreferred Program ultimately may have a direct impact on a substantial number of small entities, USDA has determined that this final rule itself does not have a direct significant economic impact on a substantial number of small entities. This rule directly affects federal agencies, which are required to consider designated products for purchase. In addition, private sector manufacturers and vendors of biobased products voluntarily may provide information to USDA through the means set forth in this rule. However, the rule imposes no requirement on manufacturers and vendors to do so, and does not differentiate between manufacturers and vendors based on size. USDA does not know how many small manufacturers and vendors may opt to participate at this stage of the program.

As explained above, when USDA issues a proposed rulemaking to designate product categories for preferred procurement under this program, USDA will assess the anticipated impact of such designations, including the impact on small entities. USDA anticipates that this program will positively impact small entities that manufacture or sell biobased products. For example, once product categories are designated, this program will provide additional opportunities for small businesses to manufacture and sell biobased products to federal agencies. This program also will impact indirectly small entities that supply biobased materials to manufacturers. Additionally, this program may decrease opportunities for small businesses that manufacture or sell non-biobased products or provide components for the manufacturing of such products. It is difficult for USDA to definitively assess these anticipated impacts on small entities until USDA proposes product categories for designation. This rule does not designate any product categories.

This final rule has been reviewed in accordance with Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and does not contain policies that have implications for these rights.

This final rule has been reviewed in accordance with Executive Order 12988, Civil Justice Reform. This rule does not preempt State or local laws, is not intended to have retroactive effect, and does not involve administrative appeals.

This final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The provisions of this rule do not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various government levels.

This final rule contains no federal mandates under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, for State, local, and tribal governments, or the private sector. Therefore, a statement under section 202 of UMRA is not required.

For the reasons set forth in the Final Rule Related Notice for 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983), this program is excluded from the scope of the Executive Order 12372, which requires intergovernmental consultation with State and local officials. This program does not directly affect State and local governments.

This final 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 final rule will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 through 3520), the information collection under the Guidelines is currently approved under OMB control number 0503-0011.

USDA is committed to compliance with the E-Government Act, which requires Government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. USDA is implementing an electronic information system for posting information voluntarily submitted by manufacturers or vendors on the products they intend to offer for federal preferred procurement under each designated item. For information pertinent to E-Government Act compliance related to this rule, please contact Ron Buckhalt at (202) 205-4008.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, that includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. USDA has submitted 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.

For the reasons stated in the preamble, the Department of Agriculture is amending 7 CFR part 3201 as follows:

The information presented in this preamble is organized as follows:

USDA is amending 7 CFR part 3202 to incorporate the statutory changes to section 9002 of the Farm Security and Rural Investment Act made by enactment of the Agricultural Act of 2014 on February 7, 2014. USDA is also finalizing amendments that clarify the rules under which the voluntary labeling program operates. The remainder of this section presents a brief summary of the amendments to the existing voluntary labeling program rules and Section IV of this preamble presents more detailed discussions.

USDA is amending 7 CFR 3202.2 by deleting the definitions of “BioPreferred Product,” “Designated item,” and “Mature market products.” USDA is also revising the definitions of “Biobased product,” “Certification mark artwork,” and “Intermediate ingredient or feedstock” and adding new definitions for “Designated product category,” “Forest product,” “Qualified biobased product,” and “Renewable chemical.” These changes are being made to bring the voluntary labeling rule up to date with the BioPreferred Program Guidelines and the 2014 Farm Bill.

USDA is adding a paragraph and subparagraphs to section 3202.4 that describe the biobased content criteria for complex assemblies. Procedures for designating complex assemblies for the federal preferred procurement initiative have been added to the BioPreferred Program Guidelines and this final rule updates the voluntary labeling program rules to include these products.

USDA is also adding paragraphs to section 3202.4 to present the criteria for evaluating whether products use “innovative approaches.” The Conference Report on the 2014 Farm Bill states that “It is the Managers' intention that all products in the program use innovative approaches in the growing, harvesting, sourcing, procuring, processing, manufacturing, or application of the biobased product.” USDA is, therefore, adopting criteria to be used when evaluating whether biobased products meet the requirement to use “innovative approaches.”

USDA is amending paragraph (a)(1) to specifically address situations where a manufacturer seeks certification for a new product that is composed of the same biobased ingredients and has the same biobased content as a previously certified product. In these cases, where a new product for which certification is sought is composed of the same biobased ingredients and has the same biobased content as a product that has already been certified, the manufacturer may, in lieu of having the new product tested, self-declare the biobased content of the new product by referencing the tested biobased content of the certified product. Certification of the original product must have been obtained by either the manufacturer of the new product or by the supplier of the biobased ingredients used in the new product. This provision will result in reduced biobased content testing, and thus a cost savings, for manufacturers who use the same biobased ingredients to formulate products that differ in size or shape or that are marketed for different applications.

USDA is also amending paragraph (c)(5) to state that manufacturers wishing to change the name of their company or the name of a certified product must notify USDA in writing within 30 days of making such changes.

USDA is also amending paragraph (d)(2) to clarify that, although certifications do not have a predetermined expiration date, they are subject to mandatory periodic auditing activities and to suspension or revocation if biobased content violations are identified. USDA is amending this paragraph to allow for the revocation of a certification if it is discovered that certification was issued as a result of error(s) on the part of USDA during the approval process.

USDA is amending paragraph 3202.8(c)(3) to correct an error in a reference cited in the paragraph. The reference to 7 CFR part 3017 is incorrect. The appropriate references are 2 CFR part 417 and 48 CFR subpart 9.4.

USDA is adding a new section 3202.10(d) that identifies three auditing efforts that will be ongoing for the voluntary labeling program. The 2014 Farm Bill contained specific language authorizing USDA to perform auditing and compliance activities necessary to ensure that the label is used only on products that meet the established eligibility criteria.

USDA expects to conduct audits of the voluntary labeling program on an ongoing basis with audit activities conducted every other calendar year (bi-annually). Audit activities will include three stages and will be conducted in sequential order. Stage 1 was conducted in 2012, Stage 2 will be conducted in 2014, and Stage 3 will be conducted in 2016. In 2018, the sequence will start over with Stage 1.

Stage 1 auditing includes contacting all participants via email and requesting that they complete a “Declaration of Conformance Form.” Program participants are asked to confirm that they still manufacture the product and that the formulation and manufacturing processes remain the same.

Stage 2 auditing consists of a random sampling of certified products to confirm the accuracy of biobased content percentages claimed. The participants whose products are selected will be required to submit product samples to be tested by independent testing labs at USDA expense.

Stage 3 auditing requires manufacturers of products that have been certified for 5 years or more to have their products re-tested at their expense to confirm that the biobased content remains at or above the level at which the product was originally certified.

USDA believes that the audit program outlined above will be a valuable tool in ensuring the integrity of the program and compliance with the voluntary labeling program rules.

The Voluntary Labeling Program for Biobased Products was established under the authority of section 9002 of the Farm Security and Rural Investment Act of 2002 (the 2002 Farm Bill), as amended by the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill), and further amended by the Agricultural Act of 2014 (the 2014 Farm Bill), 7 U.S.C. 8102. (Section 9002 of the 2002 Farm Bill, as amended by the 2008 and the 2014 Farm Bills, is referred to in this document as “section 9002”).

Section 9002 establishes a program for preferred procurement of biobased products by federal agencies and a voluntary program for the labeling of biobased products. These two programs are referred to collectively by USDA as the BioPreferred® program.

Under the preferred procurement program, federal agencies and their contractors are required to purchase biobased products, as defined in regulations implementing the statute, that are within designated product categories when the cumulative purchase price of the products to be procured is more than $10,000 or when the quantities of functionally equivalent items purchased over the preceding fiscal year equaled $10,000 or more. The final rules under which the preferred procurement program operates are found at 7 CFR part 3201, “Guidelines for Designating Biobased Products for Federal Procurement.” In a separate rulemaking, the provisions of the Guidelines are being amended to reflect the provisions of the 2014 Farm Bill.

The final rules for the voluntary labeling program, under which USDA authorizes manufacturers and vendors of biobased products to use a “USDA Certified Biobased Product” label (hereafter referred to in this preamble as “the certification mark”), are found at 7 CFR part 3202. The voluntary labeling program is intended to encourage the purchase and use of biobased products by reaching beyond the federal purchasing community and promoting the purchase of biobased products by commercial entities and the general public. In establishing this program, USDA identified the criteria to determine those products on which the certification mark may be used and developed specific requirements for how the mark can be used. It is USDA's intent that the presence of the certification mark on a product will mean that the labeled product is one for which credible factual information is available as to the biobased content, consistently measured across labeled products by use of the American Society of Testing and Materials (ASTM) radioisotope test D6866.

On July 31, 2009, USDA published a proposed rule for the voluntary labeling program under the authority of section 9002 (74 FR 38296-01). The voluntary labeling program final rule was promulgated on January 20, 2011 (76 FR 3790-01).

On February 7, 2014, the 2014 Farm Bill was signed into law and included several provisions that amended the provisions of section 9002. The primary purpose of these rule amendments is to revise the voluntary labeling program final rule to incorporate changes to section 9002 that were included in the 2014 Farm Bill. USDA is also finalizing certain clarifying amendments to the program rules based on several years of operating experience. These amendments will not affect the status of products that have already been certified by USDA to display the certification mark. However, when Stage 3 of the auditing program (7 CFR part 3202, section 3202.10) is conducted in 2016, manufacturers whose product certification is at least 5 years old will incur additional costs of about $400 per certified product for biobased content re-testing.

As a result of public comments received on the proposed amendments to the Voluntary Labeling Program regulations, USDA has made changes in finalizing the amendments. These changes are summarized in the remainder of this section. A summary of each comment received, USDA's response to the comment or group of related comments, and the rationale for any change made in the final rule is presented in section V.

USDA is finalizing the proposed definitions with no changes.

USDA revised the proposed language in paragraph (c)(2) to add the word “biobased” to the description of products or materials that qualify under criterion 1 and also added a paragraph (iii) stating that products meet the criteria if the biobased content of the product or material makes its composition different from products or material used for the same historical uses or applications.

In the final rule, USDA added a sentence at 3202.4(c)(4) to clarify that evidence of an innovative approach will not be restricted to only those innovative criteria listed in the Guidelines and that consideration of other evidence will be on a case-by-case basis.

This section has been finalized as proposed.

This section has been finalized as proposed.

This section has been finalized as proposed.

USDA solicited comments on the proposed amendments for 60 days ending on December 26, 2014. USDA received eight comments by that date. One of the comments was from an individual citizen, five were from industry trade groups, one was from an academic institution, and one was from a biobased product manufacturer. The comments are presented below, along with USDA's responses, and are grouped by the Code of Federal Regulation (CFR) section numbers to which they apply.

Comment: One commenter expressed concern that the proposed amendments to the Voluntary Labeling Program will “reduce consumer protection.” The commenter did not specify which part of the proposed amendments she was referring to but stated that she expects the government to inform and protect her and not to create an easier process for “controversial production activities including ongoing use and further development of GMO's.”

Response: USDA appreciates the commenter's interest in the BioPreferred Program but disagrees with the idea that the proposed amendments might reduce consumer protection. The purpose of the voluntary labeling program is to inform the consumer regarding the biobased content of certified products. USDA does not make or specifically endorse any claims of performance nor consumer protection or risks. The BioPreferred Program also does not evaluate or investigate the use of genetically modified organisms (GMOs) and the use of such materials is neither defended nor endorsed by the Program.

Comment: Another commenter recommended including in the Voluntary Labeling Program biochar and the process used to produce this material. The commenter described briefly what biochar is and how it may be produced. In addition, the commenter provided USDA with a research paper that may provide background information on this material.

Response: USDA agrees with the commenter and notes that a biochar product has already been certified to display the label. No change to the proposed rule language is required in response to this comment.

Comment: One commenter stated their agreement with USDA's proposed definitions for “Biobased product,” “Certification mark artwork,” and “Forest product” and none of the commenters provided adverse comments.

Response: USDA appreciates the support of the commenters.

Comment: One commenter believed that a “federal preference program” should not endorse products on the grounds that they contain biobased ingredients and that they are “new and different” from the way products were manufactured historically instead of considering whether the products are better for the environment and human health, or perform better than those that are currently available.

Response: While USDA understands the commenter's position, the statutory requirements of the 2002 Farm Bill, as amended in the 2008 and 2014 Farm Bills, mandate that the BioPreferred Program promote and give a preference to the purchase of biobased products, particularly those using “innovative approaches.” USDA does not have the authority nor the resources to evaluate the life cycle environmental and human health impacts of biobased products compared to those of traditional petroleum based products. USDA does present manufacturer-supplied information regarding the performance of products in cases where the manufacturer provides such information. However, as with life cycle impacts, USDA does not have the statutory authority or the resources to independently investigate the performance of products that participate in the Program.

Comment: One commenter asked USDA whether this proposed rule would be applied in a “multi-plant manufacturing scenario”: Would it be applied at the product or at the manufacturing plant level, and would one plant's compliance be sufficient for all plants?

Response: USDA certification of biobased products to display the label is product specific, but is independent of the actual manufacturing plant in which the product is produced. That is, if a manufacturer produces product A in two different locations and the product is otherwise identical, the manufacturer only has to apply for certification once and the manufacturer may select a sample for biobased content testing from either manufacturing plant. USDA believes that this procedural question is adequately covered in the Program operating procedures and has not made changes to the actual rule language.

Comment: One commenter stated that calculating the biobased content of a complex assembly is complicated and recommended that USDA provide extra guidance via written communication or webinars for companies interested in receiving certification to display the USDA Certified Biobased Product label on products that would be considered complex assemblies. The commenter explained that because “complex products” have not yet been designated as a product category for federal procurement preference they should meet or exceed the default 25% minimum biobased content requirement to receive certification to display the USDA Certified Biobased Product label. The commenter stated that companies and stakeholders will need assistance from USDA to determine appropriate eligibility conditions to “support a proposed alternative applicable minimum biobased content.”

Response: USDA appreciates the support expressed by the commenter regarding the labeling of complex assemblies and agrees that additional guidance for applicants would be beneficial. As the labeling of complex assemblies is initiated, USDA will prepare training materials that will be provided to applicants. USDA routinely provides training and guidance materials to applicants seeking to certify their products and will expand the coverage of such materials as the BioPreferred Program expands. No revisions to the proposed rule language are expected as a result of this comment.

Comment: One commenter expressed concern that § 3202.4(c) was written specifically for forestry products, which may cause issues for non-forestry products. The commenter suggested clarifying the first paragraph in § 3202.4(c) by adding the word “biobased” in front of “product” and “products.” The commenter also suggested clarifying § 3202.4(c)(2)(i) and (ii) to read:

Response: USDA agrees with the commenter that certain edits to the proposed language add clarity to the rule and, thus, will revise the proposed language for the final rule. However, USDA disagrees with the commenter's recommendation to include the statement that the manufacturing and processing criteria should be revised to specifically include processes that “add biobased content.” Many biobased products are made by replacing petroleum-based components of traditional products with biobased components, which could be characterized as adding biobased content, and these products would be covered by criterion (i)(C) in the commenter's edited paragraphs. Thus, there would be no benefit to adding a third item to the manufacturing and processing criterion.

Comment: One commenter was concerned that the proposed criterion for an Environmental Product Declaration (EPD) would “expand the reach” of the BioPreferred Program “beyond what was originally intended.” This commenter added that the EPD should merely supplement the product's participation in the BioPreferred Program, instead of being a requirement for it.

A second commenter provided USDA with two examples of a Type III EPD and noted that the EPD requires a product to meet “Product Category Rules.” The commenter pointed out that this information “may or may not be available and would require time to develop.” The commenter added that the “LCA related data” included in the EPD will assist in comparing products but inquired how federal agencies will use this data. Additionally, the commenter asked if there is an advantage to using this data as one means of defining “biobased purchasing.”

Response: In response to both commenters, USDA points out that the proposal did not make it a “requirement” that a manufacturer submit an EPD to participate in the BioPreferred Program. Submitting an EPD is one of the means available for manufacturers to demonstrate that their biobased products meet the “innovative approach” criteria. Various other types of documentation are also acceptable. Also, in response to the second commenter, USDA agrees that not all manufacturers have EPDs for their products and that the completion of an EPD can be time consuming. The purpose of requesting documentation such as, but not limited to, an EPD is to demonstrate that the manufacturer meet Congress' intention that “all products in the program use innovative approaches in the growing, harvesting, sourcing, procuring, processing, manufacturing, or application of the biobased product.” Because not all manufacturers have performed an EPD, USDA does not believe that it would be beneficial to require this type of data in defining “biobased purchases” by federal agencies. USDA's position is that purchases of biobased products that have been accepted into the BioPreferred Program and are, thus, listed in the Program's Biobased product catalog are eligible to be counted as “biobased purchases.”

Comment: One commenter wanted USDA to take into account that a finished wood product may be sourced domestically or globally; thus, the commenter cautioned USDA that the criteria proposed in § 3202.4(c)(4) do not “inadvertently create a technical barrier to trade” and do not exclude imported wood products that were harvested and exported legally in the U.S. and their country of harvest. This commenter recommended that USDA recognize in the proposed rule that new certification measures for forestry products develop every year and encouraged USDA to include “new legality systems,” for example, the Voluntary Partnership Agreements under the European Union's Forest Law Enforcement, Governance and Trade Action Plan as another way to demonstrate innovation. In addition, the commenter advised USDA to be aware that the definitions for “legal, responsible, or certified sources are not applied in a manner that prevents innovation in forestry management and certification.” The commenter looked forward to “working closely with USDA” to help implement these rules.

Response: USDA agrees with the commenters that the proposed innovative criteria should not be considered as an all-inclusive list. USDA recognizes that sustainability advances are occurring worldwide and does not intend that new and valid certifications be excluded from consideration by the BioPreferred Program. In the final rule, USDA will clarify that evidence of an innovative approach will not be restricted to only those innovative criteria listed in the Guidelines and that consideration of other evidence will be on a case-by-case basis.

Comment: While one commenter specifically supported this section of the proposed rule, another expressed concern regarding a manufacturer's ability to waive testing via ASTM D6866 and to self-declare its product's biobased content by referencing the tested biobased content of a product that has already been certified if both products share the same biobased ingredients and biobased content. The commenter indicated that this approach would work smoothly if these products are made by the same manufacturer; however, “complications” could arise if the manufacturers are different. Thus, the commenter suggested that USDA clarify how manufacturers are supposed to proceed and recommended that USDA make sure this proposed approach does not cause the manufacturer of the initially certified product to have a disadvantage, as that manufacturer “would carry the entire burden and cost of testing.” Thus, the commenter stated that USDA should consider any obligations that the manufacturer of the initially certified product may have to check the biobased content of the new product before sharing its certification. The commenter added that because USDA has not provided guidance on the conditions in which certifications may be shared, USDA should be “proactive” in doing so to address any questions that manufacturers will have.

The same commenter stated appreciation for the proposed rule but recommended that USDA develop methods for downstream companies that use USDA Certified Biobased chemicals/products in their formulations. The commenter stated that companies that choose to blend USDA Certified Biobased chemicals/products in their products should be able to display the USDA Certified Biobased Product label.

Response: USDA agrees with the commenter that the “self-declare” procedure should not result in a situation where one manufacturer is relieved of the cost of testing the biobased content of their product at the expense of another manufacturer without permission. The proposed rule language restricts the use of this provision to (1) manufacturers seeking certification of additional products they manufacture that have the same formulation as a previously certified product and (2) manufacturers whose products are made from certified intermediate ingredients in those cases where the manufacturer of the certified intermediate ingredient gives permission to use the test results from their product. It is not OPPM's intention that one manufacturer be allowed to use the test results from another manufacturer without the approval and cooperation of the party who paid for the testing. USDA also points out that the commenter's statement regarding “downstream” companies is addressed by USDA plans to designate for federal procurement those finished products that are made from designated intermediate ingredients and feedstock materials. USDA does not believe the any changes in the proposed rule language are necessary as a result of this comment.

No comments were received on the revisions proposed for this section.

Comment: One commenter expressed support specifically for USDA's periodic auditing activities.

Response: USDA appreciates the commenter's support for the auditing plans as described in the proposed rule.

Executive Orders 13563 and 12866 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). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “non-significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the final rule was not reviewed by the Office of Management and Budget.

This final rule amends the voluntary labeling program rules to establish the regulatory framework for the labeling of products that were previously excluded from the program because they were mature market products. The designation of such products is specifically required under the Agricultural Act of 2014, which states that the Guidelines shall: “(vi) Promote biobased products, including forest products, that apply an innovative approach to growing, harvesting, sourcing, procuring, processing, manufacturing, or application of biobased products regardless of the date of entry into the marketplace.”

This rule advances the objectives of the BioPreferred Program, as envisioned by Congress in the 2002, 2008 and 2014 Farm Bills, by expanding the scope of products that may be certified to display the USDA Certified Biobased Product certification mark. The entry into the voluntary labeling program of biobased products that were previously considered to be mature market products provides newly developed biobased products the opportunity to be publicized via the BioPreferred Web site. Thus, the rule is expected to increase demand for these products, which, in turn, is expected to increase demand for those agricultural products that can serve as ingredients and feedstocks. This expansion of the voluntary labeling program will, thus, yield private benefits for businesses producing these ingredients and feedstocks.

Simultaneously, this action could reduce demand for competing products that are not eligible for the voluntary labeling program. Producers of biobased products, including intermediate ingredients and feedstocks, that are not certified for labeling or producers of non-biobased products could face a loss of market share within both the public and federal agencies. USDA does not have sufficient information on the expected extent of this potential loss of market share to assign a dollar value to this impact.

As part of the Stage 3 auditing process to be conducted during calendar year 2016, manufacturers of biobased products that have been certified for five or more years will be required to have their products biobased content re-tested. We estimate that the cost for product re-testing is about $300 to $400 per product. The labeling program was implemented in 2011 and only those products that were certified during 2011 will incur the re-testing cost of the Stage 3 audit to be conducted during 2016. There were 1,338 applications for certification received during 2011 and USDA estimates that 1,000 of the products represented by those applications continue to display the label under the original certification. Thus, the total estimated cost of the auditing effort to all manufacturers is expected to be, at most, $400,000 (1,000 products × $400 per test) during 2016. Considering that this total cost would be spread over several hundred manufacturers making these products and that no additional re-testing costs are expected until the year 2022, USDA believes that the cost to any one manufacturer is reasonable.

The RFA, 5 U.S.C. 601-602, generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.

Although the voluntary labeling program ultimately may have a direct impact on a substantial number of small entities, USDA has determined that this final rule itself will not have a direct significant economic impact on a substantial number of small entities. Private sector manufacturers and vendors of biobased products voluntarily may provide information to USDA through the means set forth in this rule. However, the rule imposes no requirement on manufacturers and vendors to do so, and does not differentiate between manufacturers and vendors based on size. USDA does not know how many small manufacturers and vendors may opt to participate in the voluntary labeling program. USDA anticipates that this program will positively impact small entities which manufacture or sell biobased products by allowing them to display the certification mark and to list their products in the BioPreferred Program Web site catalog. However, this program may decrease opportunities for small businesses that manufacture or sell non-biobased products or provide components for the manufacturing of such products. It is, however, not possible for USDA to definitively assess these anticipated impacts on small entities.

This final rule has been reviewed in accordance with Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and does not contain policies that have implications for these rights.

This final rule has been reviewed in accordance with Executive Order 12988, Civil Justice Reform. This rule does not preempt State or local laws, is not intended to have retroactive effect, and does not involve administrative appeals.

This final rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment. The provisions of this rule do not have a substantial direct effect on States or their political subdivisions or on the distribution of power and responsibilities among the various government levels.

This final rule contains no federal mandates under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), 2 U.S.C. 1531-1538, for State, local, and tribal governments, or the private sector. Therefore, a statement under section 202 of UMRA is not required.

For the reasons set forth in the Final Rule Related Notice for 7 CFR part 3015, subpart V (48 FR 29115, June 24, 1983), this program is excluded from the scope of the Executive Order 12372, which requires intergovernmental consultation with State and local officials. This program does not directly affect State and local governments.

This final 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 final rule will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 through 3520), the information collection under the voluntary labeling program is currently approved under OMB control number 0503-0020.

USDA is committed to compliance with the E-Government Act, which requires Government agencies, in general, to provide the public the option of submitting information or transacting business electronically to the maximum extent possible. USDA is implementing an electronic information system for posting information voluntarily submitted by manufacturers or vendors on the products they intend to offer for federal preferred procurement under each designated item. For information pertinent to E-Government Act compliance related to this rule, please contact Ron Buckhalt at (202) 205-4008.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, that includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. USDA has submitted 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.

For the reasons stated in the preamble, the Department of Agriculture is amending 7 CFR part 3202 as follows:

Section 7(m) of the Small Business Act (15 U.S.C. 636(m)) (“Act”) authorizes SBA's Microloan Program, which assists small businesses that need small amounts of financial assistance. Under the program, SBA makes direct loans to Intermediaries, as defined in § 120.701(e), that use the loan proceeds to make microloans to eligible borrowers. SBA is also authorized to make grants to Intermediaries to be used for marketing, management, and technical assistance.

On March 17, 2014, SBA published a proposed rule in the Federal Register in order to clarify certain program requirements that have caused confusion and in response to feedback from existing Intermediaries. The changes proposed by SBA included: (1) revising the definition of insured depository institution in § 120.701(d) to specifically include Federally-insured credit unions; (2) amending § 120.707(a) to allow Intermediaries to make loans to businesses with an Associate, as defined in § 120.10, who is currently on probation or parole, except in limited circumstances; (3) removing the requirement that Deposit Accounts, as defined in § 120.701(a), be interest-bearing; and (4) increasing the minimum number of microloans Intermediaries are required to close and fund each year. The proposed rule also included a technical amendment to conform the regulations to current statutory authority. The comment period was open until May 16, 2014.

A summary of the comments received on the four proposed changes follows. There were no comments on the technical amendment. The final rule also includes two additional technical amendments that remove provisions with expired statutory authority, as further described below.

SBA received 19 written comments on the proposed rule during the comment period. Three of the comments addressed issues unrelated to the proposed rule changes; the remaining 16 comments were carefully considered. Commenters included several trade associations/advocacy groups and Intermediaries currently participating in the Microloan program. In general, commenters were supportive of the proposed changes. A section-by-section discussion of the comments received and the changes made follows.

A. Use of Federally-Insured Credit Unions. SBA received six comments regarding the proposal to revise the definition of insured depository institution in § 120.701(d) to specifically include Federally-insured credit unions. This change would clarify that Federally-insured credit unions are approved depositories for Microloan Revolving Funds and Loan Loss Reserve Funds. Five of the commenters, including two national advocacy groups, fully supported the revision, citing the need for Intermediaries to be able to use financial institutions that best meet their needs. One commenter opposed the change based on an overall opinion that credit unions have a competitive advantage over banks.

SBA agrees that Microloan Program Intermediaries should be allowed to use the type of depository institution that best meets their needs, as long as the institution is federally insured. Proposed § 120.701(d) is adopted without change.

B. Expanded Eligibility. SBA received ten comments regarding the proposal to allow Intermediaries to make loans to businesses with an Associate who is currently on probation or parole, most of which were supportive of the change. One commenter indicated that SBA should better define a “crime involving fraud or dishonesty.” An industry organization requested that SBA clarify that the change would allow Intermediaries to choose to make loans to businesses with an Associate on probation or parole, but would not require Intermediaries to make such loans. The organization also indicated that one of its members felt that these particular microloans may call for a high level of collateralization. The organization also asked why this allowance was being made only for the Microloan program, and not for SBA's guaranteed business loan programs (7(a) and 504). Another commenter stated the need for a high level of trust in the borrower by the Intermediary.

Expanding eligibility for the Microloan Program will allow for increased creation of new businesses and will reduce the Federal barriers to successful reentry of formerly incarcerated individuals, who often have difficulty finding steady employment. The Agency developed this revision to the Microloan Program eligibility requirements as a result of a regulatory review conducted in connection with SBA's participation on the Federal Interagency Reentry Council. SBA's Microloan Program offers an opportunity for formerly incarcerated individuals who meet the Intermediaries' lending criteria to receive financing and technical assistance to start their own businesses.

Risk to the taxpayer is mitigated because the Intermediary makes lending decisions locally, and provides microborrowers with training and technical assistance to help them learn to manage, market, and grow their small businesses. Furthermore, unlike in SBA's 7(a) and 504 programs, microloans are not guaranteed by SBA. Intermediaries are responsible for ensuring that their borrowers repay, and Intermediaries are obligated to repay their loans to SBA regardless of the performance of the microloans funded using those loan proceeds.

SBA agrees that a clarified definition of “crime involving fraud or dishonesty” should be provided and will do so via updates to the Microloan Program Standard Operating Procedures (SOP 52 00), which provides details regarding Microloan Program operations. The SOP will provide examples of crimes involving fraud or dishonesty, such as larceny, theft, embezzlement, and forgery. As to the comment suggesting that loans to the expanded population would have to be highly collateralized due to the “inherent risk of recidivism,” there was no accompanying data or research provided by the commenter that demonstrated a higher level of risk of repayment in this community. As with all other microloans, Intermediaries that choose to make loans to this newly eligible population may follow their own policies and procedures, including the same collateral policies applicable to their other borrowers, as long as they do not conflict with Microloan Program requirements. In addition, while this change to the rule expands borrower eligibility, it does not impose any requirements on Intermediaries to make loans to this newly eligible population. Proposed § 120.707 is adopted without change.

C. Interest Bearing Deposit Accounts. SBA received seven comments regarding removal of the requirement that Microloan Revolving Funds and Loan Loss Reserve Funds be held in deposit accounts that are interest bearing. All were in full favor of removal of the restriction. The provision is adopted as proposed.

D. Increased Minimum Microloan Requirement. SBA received 13 comments regarding § 120.716, which proposed to increase the minimum number of loans that an Intermediary must make each Federal fiscal year from four loans to twelve loans, and also specifically stated that Intermediaries that do not meet the minimum loan requirement are not eligible to receive new grant funding.

One commenter questioned whether it would be possible for an Intermediary to meet the minimum loan requirement during the last years of the term of the Intermediary's SBA loan, when the loan balance may not support an additional twelve loans. SBA does not believe that this comment warrants a change in the final rule, for a number of reasons. The minimum loan requirement is an overall requirement, not one based on each SBA loan to an Intermediary. The majority of Intermediaries in the Microloan program have multiple outstanding SBA loans; therefore it is rare for an Intermediary to rely on only one SBA loan as the source of its Microloan funds.

A trade organization questioned SBA's proposal to establish an across the board 12 loan minimum threshold for all lenders and suggested that SBA consider looking at other indicators in addition to the volume of loans made, such as the total amount of loans made. SBA believes that number of loans, rather than dollar volume of loans, is the most appropriate indicator for the Microloan Program. The Act specifically states that one of the purposes of the Program is to enable Intermediaries “to provide small-scale loans, particularly loans in amounts averaging not more than $10,000.” (15 U.S.C. 636(m)(1)(A)(iii)(I)). In addition, the statute provides incentives, including lower costs of funds and additional grant funding, to Intermediaries that make smaller loans. Furthermore, despite the recent increase in the maximum microloan amount to $50,000, Congress did not similarly raise the average dollar amount threshold required to qualify for the incentives mentioned above.

Assuming the same number of loans per year, the volume of lending for an Intermediary with an average loan size of less than $10,000 is significantly less than the volume of lending for an Intermediary with an average loan size above $25,000. Therefore, SBA does not feel it is appropriate to measure Intermediaries based on volume of dollars loaned. Such a measure would disproportionally harm Intermediaries that make the smallest dollar loans and provide Intermediaries with an incentive to do larger loans. Given these facts, SBA believes that a standard based on number of loans is more consistent with Congressional intent than a standard based on dollar volume of loans.

The current minimum loan requirement is four loans per year. Proposed § 120.716 would have gradually increased the minimum loan requirement over a three-year period to twelve loans per year. Most of the commenters generally supported increasing the minimum number of microloans from the current requirement. Five commenters supported increasing the requirement to twelve loans per year, as proposed. Several commenters supported a smaller increase in the minimum loan requirement, such as six, eight or ten loans per year. Some commenters were concerned that rural Intermediaries, small Intermediaries, and Intermediaries serving smaller geographic areas would be unable to meet a twelve loan requirement, and would therefore become ineligible to receive grant funding. Several of these commenters recommended a prorated approach to grant funding so as not to penalize the microloan borrowers of Intermediaries that fail to make the minimum required number of loans.

In response to these comments, SBA has reduced the minimum loan requirement from twelve loans to ten loans and modified the rule to provide a corrective action process and possible eligibility for reduced grants for Intermediaries that make less than the minimum required number of loans. As in the proposed rule, there will be a gradual ramp-up period: six microloans in fiscal year 2016, eight microloans in fiscal year 2017, and ten microloans in fiscal year 2018 and thereafter. SBA also added a provision to clarify that the minimum loan requirement for fiscal year 2015 remains four microloans. Based on average loan data for active Intermediaries (i.e., Intermediaries that make at least four loans per year) over the past five years, approximately 61 active Intermediaries would need to increase loan production in order to meet the proposed rule requirement of twelve loans per year. Using this same data, 51 active Intermediaries would need to increase production to meet the requirement of ten loans per year. This represents a 16% decrease in the number of Intermediaries that will be affected by the new loan production requirement of ten loans per year. Section 120.716(a) has been revised to incorporate this lower minimum loan requirement.

In addition, SBA has revised § 120.716(b) to include a corrective action process for Intermediaries that do not meet the minimum loan requirement. SBA determines whether an Intermediary is eligible for grant funding based on the number of microloans made in the previous Federal fiscal year. Under the proposed rule, an Intermediary that did not make the minimum number of microloans in the previous year would be ineligible for any grant funds. In response to comments received on the proposed rule, SBA revised § 120.716(b) to allow Intermediaries that do not meet the minimum loan requirement to submit corrective action plans to SBA. An Intermediary that submits an acceptable corrective action plan may be awarded a reduced grant. This change makes it possible for Intermediaries that have not met the minimum loan requirement, but are taking steps to improve loan production, to still receive some grant funding. Conditions for reduced grants and details on corrective action plan submission requirements will be provided in the Microloan SOP.

Several commenters also pointed out that it could be difficult for a new Intermediary to make the required number of loans per year, and suggested an exception for these Intermediaries. In response to these comments, SBA revised § 120.716(a) to provide that a new Intermediary is not required to meet the minimum loan requirement during the year it enters the program.

Another commenter asked whether an Intermediary that has multiple loans from SBA is required to meet minimum loan requirements for each such SBA loan. The minimum loan requirement is an overall requirement; it does not increase based on the number of loans the Intermediary has outstanding from SBA.

An advocacy group that supported the proposed minimum loan requirement nonetheless raised a concern that an increase in the minimum loan requirement might create a gap in the availability of funds for businesses in need of larger loans in the $20,000 to $50,000 range, because Intermediaries would make more small-dollar loans in order to meet the requirements. SBA does not anticipate that Intermediaries with average loan sizes of $20,000 or more (which currently make up 39% of all Intermediaries) will significantly alter their lending practices as a result of the increased loan production requirements. Furthermore, none of the comments from current Intermediaries indicated that average loan sizes would be likely to change as a result of the increased loan requirement.

The final rule revises § 120.712(d), Intermediaries eligible to receive additional grant monies, to remove subparagraph (1), which provided additional grant eligibility for an Intermediary that makes at least 25 percent of its loans to small businesses located in or owned by residents of an Economically Distressed Area. The authority to provide additional grants to such Intermediaries expired on October 1, 1997. See Public Law 103-403, section 208(c). Under current statutory authority, only Intermediaries that maintain a microloan portfolio averaging $10,000 or less, defined as Specialized Intermediaries in § 120.701, are eligible to receive additional grant funding.

The final rule also removes the definition of Economically Distressed Area in § 120.701(b), because that term was only present in former § 120.712(c) and (d)(1). As stated above, subparagraph (1) of § 120.712(d) was removed because the statutory authority for the provision expired. Similarly, as stated in the proposed rule, the authority for § 120.712(c) was removed from the statute in 2010.

These additional technical amendments serve only to conform program regulations to current SBA statutory authority; they do not change existing Agency practice, nor do they have any effect on program participants.

The Office of Management and Budget (OMB) has determined that this final rule is a significant regulatory action for purposes of Executive Order 12866. However, this is not a major rule under the Congressional Review Act, 5 U.S.C. 800. A Regulatory Impact Analysis was published in the proposed rule. In summary, the regulatory objectives include: allowing Federally-insured credit unions to hold MRF and LLRF accounts; allowing any Microloan Program Intermediary to make a microloan (loan of $50,000 or less) to a business with an Associate who is on probation or parole; removing the requirement that the Microloan Revolving Fund (MRF) and Loan Loss Reserve Fund (LLRF) be held in interest bearing deposit accounts; increasing the minimum number of loans that an Intermediary must make annually in order to qualify for grant funding; and, adding technical amendments that conform the regulations to current statutory authority. No comments were received regarding the Regulatory Impact Analysis.

A description of the need for this regulatory action and the benefits and costs associated with this action, including possible distributional impacts that relate to Executive Order 13563, were included in the Regulatory Impact Analysis under Executive Order 12866. The changes would impact approximately 50 Microloan Intermediaries that generally make fewer than 10 loans per year but more than three loans. It is anticipated that the costs to the Intermediaries will be only those associated with the operating expenses associated with making and servicing an increased number of loans. SBA does not anticipate any impact on the program's subsidy model and believes that Intermediaries will continue to make prudent lending decisions. SBA also anticipates improved use of resources as more microloans are made.

Based on the analysis of the Federal Interagency Reentry Council from 2010 (http://csgjusticecenter.org/nrrc/facts-and-trends/) there are some 4.9 million probationers and parolees. Therefore, SBA believes that the regulatory changes will expand access to capital for people who are not easily employable, but who have the capacity to operate a small business, will reduce program costs, and better utilize taxpayer dollars.

This action meets applicable standards set forth in Sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have retroactive or preemptive effect.

SBA has determined that this final rule will not have substantial, direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, for the purpose of Executive Order 13132, SBA has determined that this final rule has no federalism implications warranting preparation of a federalism assessment.

Executive Order (E.O.) 13563 reaffirms the principles of E.O. 12866 while calling for improvements to promote predictability, reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13563 further emphasizes that regulations be based in the best available science and that the rulemaking process allow for public participation and the open exchange of ideas. This rule has been developed consistent with these requirements and is written with the idea of reducing the number and burden of regulations.

The Microloan Program operates through SBA lending partners, which are Intermediary lenders. Prior to publication of the proposed rule, the Agency presented the proposals in meetings which allowed it to reach the vast majority of Microloan Program participants and stakeholder trade associations. In this way, the Agency was able to gain valuable insight, guidance, and suggestions from interested parties.

As discussed above, in response to comments received, SBA is making a change in the final rule that will require Intermediaries that are not in compliance with the minimum loan standards to submit a corrective action plan to the Agency as a condition of receiving a grant. Section 120.716(b). However, this change does not impose a new reporting requirement. Currently, SBA may require microloan Intermediaries that are generally not in compliance with program requirements to submit a corrective plan outlining how the Intermediary intends to resolve its noncompliance issues. This requirement is covered under OMB-approved information collection number 3245-0365, SBA Lender, Microloan Intermediary, and NTAP Reporting Requirements.

The Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires administrative agencies to consider the economic impact of their actions on small entities, including small businesses, small nonprofit businesses, and small local governments. The RFA requires the Agency to prepare a regulatory flexibility analysis describing the economic impact that the rule will have on small entities, or certify that the rule will not have a significant economic impact on a substantial number of small entities.

SBA has determined that although the rulemaking will impact all of the approximately 145 Intermediaries, such impact will not be significant. All of the Intermediaries are small nonprofit or quasi-governmental entities. Approximately 63 existing Intermediaries (43 percent), including Intermediaries that are not currently active, will be required to increase loan production in order to meet new minimum lending requirements. To minimize hardship, SBA will increase the minimum lending requirement in a graduated fashion: six microloans in 2016, 8 microloans in 2017, and 10 microloans in 2018 and thereafter. This graduated increase will provide Intermediaries with time to ramp up loan production to meet the higher requirements. SBA anticipates that a small number of Intermediaries may choose to end their participation in the Microloan Program as a result of the new requirements. However, these entities are making so few loans, and generating such a small amount of revenue from these microloans, that exiting the program will not cause a significant economic impact for the Intermediaries or for potential borrowers. The 63 affected Intermediaries represent an estimated 315 total microloans for approximately $5.3 million, or 5 microloans per Intermediary. Over the past five years, the Microloan Program has averaged 4,180 microloans totaling $49.3 million. Therefore, even if all of the affected Intermediaries left the program, the impact would reduce microloan volumes by just 7.5 percent in terms of number of loans and 10.9 percent in terms of volume of loans. These estimates assume that all 63 impacted Intermediaries would leave the Program. SBA believes that the number of Intermediaries choosing to leave the Program would actually be significantly less, further reducing potential economic impact. In addition, although failure to meet the minimum loan requirement is grounds for an enforcement action under § 120.1425, SBA does not currently anticipate using the minimum loan requirement as the sole basis for taking enforcement actions against Intermediaries.

SBA estimates that entities leaving the program will lose approximately $23,000 in annual revenue associated with microloans that would have been made under the SBA Microloan Program. The $23,000 represents approximate annual interest and fee income for five microloans of $17,000. An organization making just five microloans a year is not sustainable and must rely on other sources of income to operate. Microloan Intermediaries average more than $1.25 million in annual revenues; $23,000 in lost revenue represents less than 2 percent of total annual revenues per affected Intermediary.

No comments were received regarding economic impact except that some small Intermediaries indicated concern that they would not be able to appropriately serve rural areas. This concern has been addressed in the final rule by reducing the minimum loan requirement from twelve loans to ten loans per year and providing a corrective action process by which Intermediaries that do not meet the minimum loan requirement may still be eligible for grant funding at a reduced amount. Accordingly, the SBA Administrator hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities.

For reasons stated in the preamble, the U.S. Small Business Administration amends 13 CFR part 120 as follows:

The Gulf of the Farallones National Marine Sanctuary (GFNMS) was designated in 1981 and was originally named the Point Reyes/Farallon Islands National Marine Sanctuary. The name was changed to Gulf of the Farallones National Marine Sanctuary on January 27, 1997 (62 FR 3788). In March 2015, NOAA expanded the sanctuary from approximately 1,282 square miles (968 square nautical miles) to approximately 3,295 square miles (2,488 square nautical miles)(80 FR 13078).

This document provides notice that pursuant to Section 304(b) of the National Marine Sanctuaries Act (16 U.S.C. 1434(b)), the final regulations for GFNMS and Cordell Bank National Marine Sanctuary published on March 12, 2015 (80 FR 13078) took effect after 45 days of continuous session of Congress beginning on March 12, 2015. Through this notice, NOAA is announcing the regulations became effective on June 9, 2015. The final rule published on March 12, 2015 postponed for 6 months the effective date for the discharge requirements in both expansion areas with regard to U.S. Coast Guard activities, starting on the day when the rest of the final rule became effective. Therefore the effective date for the discharge requirements in both expansion areas with regard to U.S. Coast Guard activities is December 9, 2015.

With this expansion, which extends the scope of the sanctuary well beyond the Farralon Islands, the existing name “Gulf of the Farallones” no longer adequately reflects the area's bioregion. The need to change the sanctuary's name was raised during the public hearings on the GFNMS expansion. Consequently, the GFNMS Sanctuary Advisory Council established a subcommittee to explore a potential new name for the expanded sanctuary. GFNMS staff, working with a team of marketing experts, then developed a list of 30 potential names and presented them to the subcommittee, which narrowed the list to three names for consideration by the full Advisory Council on November 19, 2014. On February 25, 2015, the Advisory Council recommended two options to the GFNMS Superintendent: (1) Keeping the name “Gulf of the Farallones National Marine Sanctuary” because the name is familiar and still represents one of the core elements of the sanctuary ecosystem; and (2) changing the name to the Greater Farallones National Marine Sanctuary to better capture the added features of the expanded sanctuary. After reviewing both of these recommendations carefully, NOAA decided on “Greater Farallones National Marine Sanctuary” to be more inclusive and representative of the expanded sanctuary.

This final rule has been determined to be not significant for purposes of the meaning of Executive Order 12866.

The Assistant Administrator of the National Ocean Service (NOS) finds good cause pursuant to 5 U.S.C. 553(b)(B) to waive the notice and comment requirements of the Administrative Procedure Act because this amendment is technical in nature, having no substantive impact, and no useful purpose would be served by providing notice and opportunity for comment under the Administrative Procedure Act. Nor is a 30-day delay in effective date required under 5 U.S.C. 553(d) due to the non-substantive nature of this technical amendment. NOAA has decided to make this document effective upon publication because public comment and delayed effectiveness are unnecessary.

Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are inapplicable. Therefore, a regulatory flexibility analysis is not required and has not been prepared.

Accordingly, for the reasons discussed in the preamble, the National Oceanic and Atmospheric Administration amends 15 CFR part 922 as follows:

Congress enacted the GPO in 1977 to reduce the Social Security spouse's benefit of workers who receive a government pension based on noncovered employment. A Social Security spouse's old-age benefit is a benefit that, under certain circumstances, the spouse, widow(er), mother, father, divorced spouse, or surviving divorced spouse of an insured person is entitled to receive. Congress created spouse's benefits to help people who depend on their working spouses for financial support, either because they did not work or did not work long enough to be entitled to their own Social Security retirement benefit.

Spouse's benefits are separate from the Social Security retirement benefits earned based on an individual's own earnings record. We base a spouse's benefit on the Social Security earnings record of an individual's current, deceased, or former spouse. The GPO does not apply to Social Security retirement or disability benefits that we base on an individual's own earnings.

Under the Social Security program, an individual who is entitled to more than one Social Security benefit at the same time does not receive the full amount of each benefit. For example, an individual who worked and paid Social Security taxes may be eligible for a retirement benefit based on his or her own earnings and may also be eligible for spouse's benefits based on another person's earnings. In this case, if the spouse's benefit is greater than the individual's retirement benefit, we will reduce the spouse's benefit by the amount of the individual's own retirement benefit. Therefore, the individual's own retirement benefit “offsets” the benefit amount paid as a spouse.

In certain instances, an individual may earn wages but not pay Social Security taxes. We call this noncovered work. This situation exists for some Federal, State, and local government employees who contributed to a government-employee pension plan and receive a government pension. Since these individuals did not pay Social Security taxes on their noncovered employment, they are not eligible for Social Security retirement benefits based on that work. However, they may be eligible for Social Security spouse's benefits.

Congress believed that individuals who received a government pension based on their own noncovered work would receive a “windfall” if they also received Social Security spouse's benefits that their government pension did not offset.1 To prevent this “windfall,” Congress passed the GPO provision in 1977.2 The GPO treats government workers similarly to individuals who worked in jobs that Social Security covered by reducing their Social Security spouse's benefit when they receive a government pension based on their own noncovered work.

Under the 1977 law, the GPO did not apply if Social Security covered the person's last day of government employment. The wording of this law allowed an individual to spend an entire career in a noncovered job and avoid the GPO by working in a covered job for only 1 day. To close this “last day loophole,” Congress enacted section 418 of the SSPA, Public Law 108-203, which amended the GPO provision of the Act. This amendment, made by section 418, requires that an individual's final 60 months of government work must be covered by both Social Security and the pension plan that provides the government pension in order to be exempt from the GPO. This amendment also phased out the “last day” loophole and provided a transitional rule that covered people whose last day of government employment occurred within 5 years of the enactment of SSPA.

For workers whose last day of State or local government employment occurred between March 2, 2004 and March 1, 2009, we will reduce the 60-month requirement by the total number of months that the worker served in covered employment on or before March 2, 2004. The worker must perform the remaining month(s) of service needed to fulfill this 60-month requirement after March 2, 2004. Therefore, even if a worker had 60 or more months of covered government service on or before March 2, 2004, that worker would still have to work his or her last month of covered government service after March 2, 2004.

The last 60-month requirement established by section 418 of the SSPA is similar to a requirement established by section 9007 of the OBRA 1987, Public Law 100-203. Section 9007 specified that Federal employees who transfer from the Civil Service Retirement System to the Federal Employees Retirement System must work for at least 60 months, taken together, in covered employment in order to avoid application of the GPO.

On August 3, 2007, we published an NPRM in the Federal Register at 72 FR 43202 proposing to revise our regulations to reflect the changes to the GPO made by section 418 of SSPA and section 9007 of the OBRA 1987. We are finalizing the changes announced in the NPRM, with the modifications noted below.

We re-worded and reorganized the proposed regulatory language to better explain how we apply the GPO rules. These changes make the regulations clearer and easier to understand. The language changes do not affect the substance of the regulation as proposed in our NPRM.

In the NPRM, we proposed replacing the words “receiving” and “received” with the word “payable.” We decided against this change. Variations of the term “receive” more clearly describe the fact that a government pension plan must pay a person a periodic benefit from for GPO to apply. Additionally, use of the term “receive” in this section maintains consistency throughout our regulations.

We simplified the language in proposed 404.408a(a)(1), and redesignated the section as 404.408a(a)(2).We redesignated proposed 404.408a(a)(1) as (a)(2) because we are adding a new 404.408a(a)(1). In the proposed rules, we used the terms “government pension” and “noncovered employment” without a definition. We also referred to an individual's “Social Security benefits as a wife, husband, widow, widower, mother or father, divorced or surviving divorced spouse” throughout proposed 404.408a(a), as well as in proposed 404.408a(b) and (d).

To simplify and clarify the rules, we added a definitional paragraph to 404.408a(a) for these terms. We defined the terms government pension and noncovered employment in 404.408a(a)(1)(i) and (a)(1)(ii) and added 404.408a(a)(2)(iii) to define “spouse's benefits,” which is a single term used to represent those beneficiaries affected by this section: Wives, husbands, widows, widowers, mothers, fathers, divorced or surviving divorced spouses. Using a single term to describe these groups simplifies our rules and makes them easier to understand. The addition of these terms does not change or affect the categories of beneficiaries affected or change the substance of the rules we proposed.

We simplified the language in proposed 404.408a(a)(3) and moved it to 404.408a(b)(6), except for the final sentence of (3)(ii).

We revised the final sentence of proposed 404.408a(a)(3)(ii) and moved it to 404.408a(a)(2).

We simplified the first sentence of proposed 404.408a(a)(4) and moved it to 404.408a(b)(6)(ii) to clarify that it applies to the last 60 months rule.

We simplified the second sentence of proposed 404.408a(a)(4) and moved it to 404.408a(a)(1)(ii) to clarify that it applies to all of § 404.408a.

We simplified the language of proposed 404.408a(d) and added provisions from proposed paragraph 404.408a(a)(5).

We revised the language of proposed 404.408a(b)(6) and moved it to 404.408a(b)(7).

We simplified formerly proposed 404.408a(a)(2) and moved it to 404.408a(b)(8) as a new exception.

On August 3, 2007, we published an NPRM in the Federal Register at 72 FR 43202 and provided the public with a 60-day comment period. We received one comment. We carefully considered the concerns expressed in this comment but did not make any changes to the final rule as a result of the comment.

Comment: A member of the public objected to the GPO, stating that government pensions are already larger than private pensions. The commenter opined that people who receive government pensions should not get extra payments since they already receive more than workers who lack pensions.

Response: We did not adopt this comment, which reflects a misunderstanding of the GPO. The GPO does not increase government pensions and it does not increase Social Security benefits. Instead, it reduces the Social Security spouse's benefit of workers who receive a government pension based on noncovered employment. Because our current regulations reflect the purpose of the GPO, people who receive government pensions are not receiving extra payments.

We consulted with the Office of Management and Budget (OMB) and determined that this final rule does not meet the criteria for a significant regulatory action under Executive Order 12866, as supplemented by Executive Order 13563 and was not subject to OMB review.

We certify that this final rule will not have a significant economic impact on a substantial number of small entities because it affects individuals only. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

This final rule imposes no reporting or recordkeeping requirements subject to OMB clearance.

For the reasons set out in the preamble, we amend 20 CFR chapter III, part 404, subpart E as follows:

Background

The final regulations (TD 9719) that are the subject of this correction is under section 446 of the Internal Revenue Code.

As published, the final regulations (TD 9719) contain an error that may prove to be misleading and is in need of clarification.

The Department published a notice of proposed rulemaking (NPRM) in the Federal Register at 80 FR 15951, Mar. 26, 2015. The Department invited public comment on the NPRM and the accompanying system notice (SORN). The comment period closed on April 27, 2015 for both the NPRM and the SORN. The Department received two comments from members of the public regarding this system's exemption from the access provisions of the Privacy Act. The Department adjudicated the comments. Both comments supported the approval of the regulation.

Pursuant to the authority vested in the Attorney General by 5 U.S.C. 552a and delegated to me by Attorney General Order 2940-2008, 28 CFR part 16 is amended as follows:

PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC's Web site (http://www.pbgc.gov).

The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for July 2015 and updates the asset allocation interest assumptions for the third quarter (July through September) of 2015.

The third quarter 2015 interest assumptions under the allocation regulation will be 2.32 percent for the first 20 years following the valuation date and 2.37 percent thereafter. In comparison with the interest assumptions in effect for the second quarter of 2015, these interest assumptions represent no change in the select period (the period during which the select rate (the initial rate) applies), a decrease of 0.39 percent in the select rate, and a decrease of 0.41 percent in the ultimate rate (the final rate).

The July 2015 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for June 2015, these interest assumptions represent an increase of 0.50 percent in the immediate annuity rate and are otherwise unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during July 2015, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:

Electronic and Facsimile Availability

This document and additional information concerning OFAC are available from OFAC's Web site (www.treasury.gov/ofac). Certain general information pertaining to OFAC's sanctions programs also is available via facsimile through a 24-hour fax-on-demand service, tel.: 202/622-0077.

Section 321 of the Antiterrorism and Effective Death Penalty Act of 1996, 18 U.S.C. 2332d (the “Act”), makes it a criminal offense for United States persons, except as provided in regulations issued by the Secretary of the Treasury, in consultation with the Secretary of State, to engage in financial transactions with the governments of countries designated under section 6(j) of the Export Administration Act of 1979, 50 U.S.C. App. 2405(j) (the “EAA”), as supporting international terrorism. To implement section 321 of the Act, OFAC promulgated the Terrorism List Governments Sanctions Regulations, 31 CFR part 596 (the “Regulations”), effective August 22, 1996. 61 FR 43462 (Aug. 23, 1996).

Section 596.201 of the Regulations provides that, except as authorized by regulations, orders, directives, rulings, instructions, licenses, or otherwise, no United States person, knowing or having reasonable cause to know that a country is designated under section 6(j) of the EAA as a country supporting international terrorism, shall engage in a financial transaction with the government of such country. Since the promulgation of the Regulations, paragraph (b) of § 596.201 has listed those countries that are currently designated under section 6(j) (“state sponsors of terrorism”).

Upon a determination that a country should be added to the list of state sponsors of terrorism, and also upon a rescission of such a determination, the State Department publishes the determination or rescission in the Federal Register and updates the list of State Sponsors of Terrorism on its Web site at http://www.state.gov/j/ct/list/c14151.htm. On May 28, 2015, the Secretary of State issued a Public Notice rescinding the designation of Cuba as a state sponsor of terrorism. 80 FR 31945 (June 4, 2015). OFAC is taking this opportunity to replace paragraph (b) of § 596.201 with information regarding state sponsor of terrorism determinations and rescissions in the Federal Register and a reference to the current list of state sponsors of terrorism maintained on the Web site of the Department of State. A conforming amendment also is made to the authority citation for the Cuban Assets Control Regulations, 31 CFR part 515, by removing the reference to 18 U.S.C. 2332d.

Because the Regulations involve a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.

The collections of information related to the Regulations are contained in 31 CFR part 501 (the “Reporting, Procedures and Penalties Regulations”). Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.

For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR parts 515 and 596 as set forth below:

The Coast Guard is issuing this final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Grand Trunk Western Railroad bridge, that once required draw operations in 33 CFR 117.633, was removed from the waterway in 1982. Therefore, the regulation is no longer applicable and shall be removed from publication. It is unnecessary to publish an NPRM because this regulatory action does not purport to place any restrictions on mariners but rather removes a restriction that has no further use or value. Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the Federal Register. The bridge has been removed from the waterway for 33 years and this rule merely requires an administrative change to the Code of Federal Regulations, in order to omit a regulatory requirement that is no longer applicable or necessary. The removal has already taken place and the removal of the regulation will not affect mariners currently operating on this waterway. Therefore, a delayed effective date is unnecessary.

The Grand Trunk Western Railroad drawbridge at the mouth of Spring Lake, mile 0.2, was removed in 1982. It has come to the attention of the Coast Guard that the governing regulation for this drawbridge was never removed subsequent to the removal of the bridge. The elimination of this drawbridge necessitates the removal of the drawbridge operation regulation, 33 CFR 117.633(d), that pertained to the former drawbridge.

The purpose of this rule is to remove the section of 33 CFR 117.633 that refers to the Grand Trunk Western Railroad drawbridge at the mouth of Spring Lake, mile 0.2, from the Code of Federal Regulations since it governs a bridge that has been removed.

The Coast Guard is amending the regulation in 33 CFR 117.633 by removing restrictions and the regulatory burden related to the draw operations for this bridge that is no longer in existence. The amendment removes the paragraph of the regulation governing the Grand Trunk Western Railroad drawbridge since the bridge has been removed from the waterway. This Final Rule seeks to update the Code of Federal Regulations by removing language that governs the operation of the Grand Trunk Western Railroad drawbridge, which in fact no longer exists. This change does not affect waterway or land traffic. This change does not affect nor does it alter the operating schedules in 33 CFR 117.633 that governs the remaining active drawbridges on the Grand River.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The Coast Guard does not consider this rule to be “significant” under that Order because it is an administrative change and does not affect the way vessels operate on the waterway.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will have no effect on small entities since this drawbridge has been removed and the regulation governing draw operations for this bridge is no longer applicable. There is no new restriction or regulation being imposed by this rule; therefore, the Coast Guard certifies under 5 U.S.C. 605(b) that this final rule will not have a significant economic impact on a substantial number of small entities.

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

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves amending 33 CFR 117.633 in the regulations to remove a drawbridge operating regulation for a drawbridge that no longer exists. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.

Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The town of Cape Charles has not held a Clam Slam Fireworks display in the past. However, this same location is used for other firework displays throughout the year as published in 33 CFR 165.506(c). The perimeter of the safety zone and the enforcement times remain the same as that from the table, only the day of the week will change. A Notice to Proposed Rulemaking was published on March 23, 2015 in the Federal Register (79 FR 19031).

The Coast Guard received one comment on the NPRM, which is addressed below in Section C. No request for a public meeting was received, and no meeting was held.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231; 33 CFR 1.05-1, 6.04-1, 160.5; Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to propose, establish, and define regulatory safety zones.

The purpose of this safety zone is to protect the event participants, patrol vessels, spectator craft and other vessels transiting navigable waters of the Chesapeake Bay from hazards associated with a fireworks display. The potential hazards to mariners within the safety zone include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris.

The Coast Guard received one comment that fully supported the proposed actions to put in place a safety zone for the Cape Charles Clam Slam Fireworks event.

The Captain of the Port of Hampton Roads will establish a safety zone on the waters of the Chesapeake Bay within a 350 yard radius of the center located near the shoreline at position 35°15′47″ N./076°01′29″ W. (NAD 1983), in the vicinity of Cape Charles Harbor in Cape Charles, Virginia. This safety zone will be enforced on August 1, 2015 between the hours of 9:30 p.m. and 10 p.m. Access to the safety zone will be restricted during the specified dates and times.

Except for vessels authorized by the Captain of the Port or his Representative, no person or vessel may enter or remain in the safety zone during the time frame listed. The Captain of the Port will give notice of the enforcement of the safety zone by all appropriate means to provide the widest dissemination of notice among the affected segments of the public. This will include publication in the Local Notice to Mariners and Marine Information Broadcasts.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. Although this safety zone restricts vessel traffic through the regulated area, the effect of this rule will not be significant because: (i) This rule will only be enforced for the limited size and duration of the event; and (ii) the Coast Guard will make extensive notification to the maritime community via marine information broadcasts so mariners may adjust their plans accordingly.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule affects the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in waters of the Chesapeake Bay in the vicinity of Cape Charles Harbor during the enforcement period.

This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) The safety zone is of limited size and duration, and (ii) Sector Hampton Roads will issue maritime advisories widely available to users of the Chesapeake Bay in the vicinity of Cape Charles Harbor allowing mariners to adjust their plans accordingly.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone. This rule is categorically excluded from further review under paragraph 34-(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard did not receive notice of planned salvage operations until May 15, 2015. Publishing a NPRM and delaying its effective date would be impracticable and contrary to public interest because immediate action is needed to protect the United States Navy divers, TUG LITTLE BULLY, BARGE SALONAN, other vessels, and mariners from the hazards associated with the salvage of CSS GEORGIA and recovery and transport of unexploded ordnance from Savannah River.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register for the same reasons discussed above.

The legal basis for the rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

The purpose of the rule is to ensure the safety of life and vessels on a navigable waterway of the United States during the salvage of CSS GEORGIA and recovery and transport of unexploded ordnance from Savannah River.

The Coast Guard is establishing this safety zone to facilitate the safe salvage of CSS GEORGIA and recovery and transport of unexploded ordnance from the Savannah River. The salvage operations and recovery of unexploded ordnance pose a danger to other vessels that may meet, pass or attempt to overtake the BARGE SALONAN in the narrow waterway of the Savannah River. This safety zone is necessary to protect the safety of lives and persons during salvage and recovery operations.

A moving and fixed safety zone will be established when the United States Navy commences dive and salvage operations and during the recovery and river transits with unexploded ordnance. During dive and salvage operations, no vessel may pass within 100 yards of BARGE SALONAN in approximate position 32-05′02.6 N., 081-02′21.6 W. in the area of Buoy 52A, unless authorized by the COTP Savannah or designated representative, and during recovery and transit of unexploded ordnances, no other vessel may meet or pass within 500ft of the United States Navy small boat carrying the ordnance, unless authorized by the COTP Savannah or a designated representative.

Entry into the safety zone is prohibited for all vessels unless specifically authorized by the Captain of the Port (COTP) Savannah or a designated representative. Coast Guard assets or designated representatives will enforce this safety zone, and coordinate vessel movements into the zone when safe to minimize the zone's impact on vessel movements. Persons or vessels desiring to enter, transit through, anchor in, or remain within the safety zone may contact the Captain of the Port Savannah by telephone at (912) 652-4353, or a designated representative via VHF radio on channel 16, to request authorization. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the Captain of the Port Savannah or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the Captain of the Port Savannah or a designated representative. The Coast Guard will provide notice of the safety zones by Broadcast Notice to Mariners, and on-scene designated representatives.

Due to fluctuations in tide and recovery operations based upon the best available information known at the time this rule was drafted, this rule is effective from June 22, 2015 until October 1, 2015. However, it will only be enforced during dive and salvage operations and transits of unexploded ordnance. The COTP Savannah or a designated representative will inform the public through broadcast notice to mariners of the enforcement periods for this safety zone.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

The economic impact of this rule is not significant for the following reasons: This safety zone will only be enforced during times of diving operations and the recovery and transit of unexploded ordnance on the Savannah River. Once salvage operations have ceased, the safety zone will be terminated. Dive and salvage operations are only expected to take place during day light hours and are expected to last a few hours a day. The receiving site for unexploded ordnance is only 14,000 feet from the CSS GEORGIA salvage site.

The Coast Guard has notified the Georgia Ports Authority and Savannah Pilots Association of the needs, conditions, and effective dates and times of the safety zone so that they may schedule arriving and departing vessels that may be affected by this safety zone to minimize shipping delays. The presence of other moored vessels is not expected to impede salvage operations, and sufficient channel width is anticipated while the dive and salvage operations are in effect so that other vessels may transit through the area.

Notifications of the enforcement periods of this safety zone will be made to the marine community through broadcast notice to mariners. Representatives of the COTP will be on-scene to coordinate the movements of vessels seeking to enter the safety zone. These representatives will authorize vessels to transit into the zone to the maximum safe allowable extent during salvage operations.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit the Savannah River while salvage operations have commenced. This safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: (1) The COTP Savannah may consider granting vessels permission to enter into the moving and fixed safety zone if conditions allow for such transit to be conducted safely, and (2) the Coast Guard will issue a broadcast notice to mariners informing the public of the safety zone.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

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

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

Table of Acronyms DHS Department of Homeland Security FR Federal Register NPRM Notice of Proposed Rulemaking A. Regulatory History and Information

On May 8, 2015, we published a notice of proposed rulemaking (NPRM) entitled “Safety Zone for Fireworks Display, Patapsco River, Inner Harbor; Baltimore, MD” in the Federal Register (80 FR 26511). We received no comments on the proposed rule. No public meeting was requested, and none was held. The permanent safety zones listed in the Table to 33 CFR 165.506 do not apply to this event.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Event planners did not provide the Coast Guard adequate advance notice of the event to allow 30 days after publication with an appropriate period for public comment. Notice for this event was submitted to the Coast Guard on April 14, 2015.

The legal basis and authorities for this rule are found in 33 U.S.C. 1231; 33 CFR 1.05-1 and 160.5; and Department of Homeland Security Delegation No. 0170.1., which collectively authorize the Coast Guard to propose, establish, and define regulatory safety zones. Fireworks displays are frequently held from locations on or near the navigable waters of the United States. The potential hazards associated with fireworks displays are a safety concern during such events. The purpose of this rule is to promote public and maritime safety during a fireworks display, and to protect mariners transiting the area from the potential hazards associated with a fireworks display, such as the accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. This rule is needed to ensure safety on the waterway before, during and after the scheduled event.

The Coast Guard received no comments in response to the NPRM. No public meeting was requested and none was held.

During the drafting of this rule, the Coast Guard became aware that the regulatory text published in the NPRM, describing the area of the safety zone as all waters of the Patapsco River within a 300 yards radius of a fireworks discharge barge, is not correct. The required area of the safety zone is less than that published in the NPRM. This rule corrects the area of the safety zone, as all waters of the Patapsco River within a 100 yards radius of a fireworks discharge barge.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.

Although this regulation would restrict access to this area, the effect of this proposed rule will not be significant because: (i) The safety zone will only be in effect from 8:30 p.m. through 10:30 p.m. on July 2, 2015, (ii) the Coast Guard will give advance notification via maritime advisories so mariners can adjust their plans accordingly, and (iii) although the safety zone will apply to certain portions of the Inner Harbor, smaller vessel traffic will be able to transit safely around the safety zone.

The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule may affect the following entities, some of which may be small entities: the owners or operators of vessels intending to operate or transit through or within, or anchor in, the safety zone during the enforcement period.

This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons stated under paragraph D.1., Regulatory Planning and Review.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule affects your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT, above.

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

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on 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. We have analyzed this rule under that Order and determined that this rule does not have implications for federalism.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

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

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

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

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

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

This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.

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

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves establishing a temporary safety zone for a fireworks display. The fireworks are launched from navigable waters of the United States and may negatively impact the safety or other interests of waterway users and near shore activities in the event area. The activity includes fireworks launched from barges near the shoreline that generally rely on the use of navigable waters as a safety buffer to protect the public from fireworks fallouts and premature detonations. This action is necessary to protect persons and property during the project. This rule is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

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

I. Background

On March 10, 2015 (80 FR 12604), EPA published a notice of proposed rulemaking (NPR) for revisions to the Pennsylvania SIP. In the NPR, EPA proposed approval of an update to the MVEBs, updates to the point and area source inventories, and general conformity budgets for the construction of the Bell Bend Nuclear Power Plant. The formal SIP revision was submitted by Pennsylvania on May 28, 2014.

Pennsylvania's SIP revisions revised the MVEBs for the Scranton/Wilkes-Barre Maintenance Area to reflect the use of the MOVES model; made updates to the point and area source inventories; and established general conformity budgets for the construction of the Bell Bend Nuclear Power Plant. A detailed discussion of the SIP revisions can be found in the SIP submittal, NPR, and technical support document (TSD) in this docket. The rationale for EPA's action is explained in the NPR and will not be restated here. No public comments were received on the NPR.

EPA is approving an update to the MVEBs for the Scranton/Wilkes-Barre Maintenance Area, updates to the point and area source inventories for NOX, and general conformity budgets for the construction of the Bell Bend Nuclear Power Plant as revisions to the Pennsylvania SIP.

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

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

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

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

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

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

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

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

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

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

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

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

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 14, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action.

This action which approves an update to the MVEBs for the Scranton/Wilkes-Barre Maintenance Area, updates to the point and area source inventories, and general conformity budgets for the construction of the Bell Bend Nuclear Power Plant may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR part 52 is amended as follows:

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 Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2014-0176 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 14, 2015. 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-2014-0176, 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 January 28, 2015 (80 FR 4525) (FRL-9921-55), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10683) by Exponent Inc., 1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036, on behalf of Huntsman Corporation, 8600 Gosling Road, The Woodlands, TX 77381. The petition requested that 40 CFR 180.910, 180.930, and 180.940 be amended by establishing an exemption from the requirement of a tolerance for residues of di-n-butyl carbonate (CAS Reg. No. 542-52-9) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial formulations in food-contact surface sanitizer products. That document referenced a summary of the petition prepared by Exponent Inc., on behalf of Huntsman Corp., the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based on a review of the data submitted in support of this petition, EPA has modified the exemption requested by limiting the amount of di-n-butyl carbonoate allowed in food contact sanitizing solutions to a maximum 15,000 ppm (1.5%). This limitation is based on the Agency's risk assessment which can be found athttp://www.regulations.gov in document “Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” in docket ID number EPA-HQ-OPP-2014-0176.

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

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

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

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

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by di-n-butyl carbonate as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Di-n-butyl carbonate acute toxicity testing indicate that it has low acute oral, dermal and inhalation toxicity (acute oral and dermal LD50 > 2,000 milligrams/kilogram (mg/kg); acute inhalation LC50 >8 mg/Liter (mg/L) and is non-irritating to the eyes and negative for dermal sensitization. Di-n-butyl carbonate is irritating to the skin. In a combined repeated dose toxicity study with the reproductive and developmental toxicity screening test, di-n-butyl carbonate was administered daily to rats by gavage. The di-n-butyl carbonate test material did not result in any test material related mortality or clinical observations in the parental animals. No effects were observed in the functional observational battery, hematology and clotting parameters, clinical chemistry parameters, or organ weights. No macroscopic findings related to the test item were observed. No histopathological effects were reported in neurological tissues (cerebrum, cerebellum, pons, peripheral nerve, spinal cord) (cervical, midthoracic and lumbar sections) or any immunological tissues (bone marrow, thymus, spleen, lymph nodes).

The NOAEL of di-n-butyl carbonate in rats is 500 mg/kg bw/day for parental animals (males and females) and 500 mg/kg bw/day for embryo-fetal toxicity. The LOAEL is 750 mg/kg bw/day based on decreased body weight gain in male and female paternal animals and embryo-fetal toxicity at 750 mg/kg bw/day as evidenced by increased pre- and post-implantation losses and decreased total number of pups.

If ingested di-n-butyl carbonate would be readily hydrolyzed by esterases in the gut to generate two molar equivalents of n-butanol and one molar equivalent of carbonic acid. EPA has stated for the n-butanol tolerance reassessment that once absorbed, n-butanol disappears rapidly from the blood. The carbonic acid rapidly dissociates into CO2 and water.

Di-n-butyl carbonate was negative in an OCSPP Harmonized Test Guideline Bacterial Reverse Mutation Assay (at concentrations ranging from 1.5 to 5,000 ug per plate); no positive mutagenic response was observed.

There are no carcinogenicity studies available for di-n-butyl carbonate. Based on predicted rapid metabolism and excretion, the lack of specific target organ toxicity in the OCSPP Harmonized Test Guideline 870.3650 study, the results of genotoxicity testing being negative, and a Quantitative Structure Activity Relationship (QSAR) expert model, DEREK Nexus, that indicates no structural alerts for carcinogenicity, di-n-butyl carbonate is not expected to be carcinogenic.

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

No acute toxicological endpoints have been identified for di-n-butyl carbonate; therefore no acute exposure assessments are warranted.

The overall NOAEL for di-n-butyl carbonate was established at 500 mg/kg/day. The chronic risk assessment for di-n-butyl carbonate is based on this endpoint and the chronic reference dose (cRfD) is therefore 5.0 mg/kg/day. The cRfD incorporates a 10X interspecies factor and a 10X intraspecies factor. Since the FQPA SF has been reduced to 1X, the cPAD is also 5.0 mg/kg/day.

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

The Agency assessed the dietary exposures to di-n-butyl carbonate as an inert ingredient for use in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock, as well as an inert ingredient for use in food-contact surface sanitizing solutions. In the case of dietary exposures to di-n-butyl carbonate as an inert ingredient used in pesticide formulations applied to growing crops, raw agricultural commodities, and livestock, a chronic dietary exposure assessment was conducted using the Dietary Exposure Evaluation Model/Food Commodity Intake Database (DEEM-FCID) TM, Version 3.16. EPA used food consumption information from the U.S. Department of Agriculture's National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was conducted from 2003 to 2008. As to residue levels in food, no residue data were submitted for di-n-butyl carbonate. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the case of the proposed use of di-n-butyl carbonate as an inert ingredient in food-contact sanitizing pesticide products, EPA has utilized a conservative, health-protective method of estimating dietary intake that is based upon conservative assumptions related to the amount of residues that can be transferred to foods as a result of the proposed use. This same methodology has been utilized by EPA in estimating dietary exposures to antimicrobial pesticides used in food-handling settings. A complete description of the approach used to assess dietary exposures resulting from food contact sanitizing solution uses of di-n-butyl carbonate can be found at http://www.regulations.gov in document “Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 12-23 in docket ID number EPA-HQ-OPP-2014-0176.

The exposures from food and food contact sanitizing are then added together for the final dietary exposure assessment.

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

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

There are no current or proposed residential uses for di-n-butyl carbonate; however, it is possible that di-n-butyl carbonate may be used as an inert ingredient in pesticide products. A highly conservative residential exposure assessment was performed in which it was assumed that all residential use pesticide products would contain di-n-butyl carbonate as an inert ingredient. A complete description of the approach used to assess possible residential exposures from di-n-butyl carbonate can be found in http://www.regulations.gov in document “Di-n-Butyl Carbonate; Human Health Risk Assessment and Ecological Effects Assessment to Support Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient in Pesticide Formulations,” pp. 16 in docket ID number EPA-HQ-OPP-2014-0176.

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 di-n-butyl carbonate to share a common mechanism of toxicity with any other substances, and di-n-butyl carbonate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that di-n-butyl carbonate 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 athttp://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. There is evidence for qualitative susceptibility in the OECD 422 study. In this study, embryo-fetal toxicity was manifested as evidenced by increased pre- and post-implantation losses and decreased total number of pups in the presence of maternal toxicity (decreased in body weights). However, considering the overall toxicity profile and the toxicity endpoints and doses selected for di-n-butyl carbonate, the degree of concern for the effects observed in the di-n-butyl carbonate reproductive and developmental toxicity screening study is low. There is a clear NOAEL for the offspring effects, and endpoints and regulatory doses were selected for use in the dietary risk assessment to be protective of these effects.

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

i. The toxicity database for di-n-butyl carbonate summarize the studies included in the database. EPA concludes that these data are sufficient for assessing the effects of di-n-butyl carbonate on infants and children.

ii. There is no indication that di-n-butyl carbonate is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. Although there is some evidence that di-n-butyl carbonate results in increased susceptibility in rats, the degree of concern for these effects is low for the reasons explained in Unit IV.D.2.

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 as well as conservative assumptions regarding exposures from food-contact sanitizer uses. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to di-n-butyl carbonate in drinking water. These assessments will not underestimate the exposure and risks posed by di-n-butyl carbonate.

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to di-n-butyl carbonate from food and water will utilize 21% of the cPAD for the U.S. population and 94% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short- and Intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). While di-n-butyl carbonate is not currently used as an inert ingredient in pesticide products that are registered for uses that could result in short- or intermediate-term residential exposure, it is possible that di-n-butyl carbonate could be used in such products and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with potential short-and intermediate-term residential exposures to n-butyl benzoate.

Using the exposure assumptions described in this unit for short-and intermediate-term exposures, EPA has concluded the combined food, water, and residential exposures result in aggregate short- and intermediate-term MOEs of 320 for adults and 100 for children (1-2 years old). EPA's level of concern for n-butyl benzoate is a MOE of 100 or below; however, these MOEs are not of concern based on the highly conservative assumptions made regarding residential and dietary exposures to n-butyl benzoate.

4. Aggregate cancer risk for U.S. population. As discussed in Unit IV.A., di-n-butyl carbonate 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 di-n-butyl carbonate residues.

An analytical method for enforcement purposes is not required for di-n-butyl carbonate in pesticide formulations which include uses on crops for pre- and post-harvest, and on animals, since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

An analytical method is also not required for enforcement purposes for di-n-butyl carbonate on food-contact surfaces in antimicrobial applications since the Agency is not establishing a numerical tolerance for residues of di-n-butyl carbonate in or on any food commodities. EPA is establishing a limitation on the amount of di-n-butyl carbonate that may be used in food-contact surface antimicrobial applications. That limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”), 7 U.S.C. 136 et seq. EPA will not register any food-contact surface antimicrobial applications for sale or distribution that contains greater than 15,000 ppm (1.5%) of di-n-butyl carbonate by weight.

Therefore, exemptions from the requirement of a tolerance is established under 40 CFR 180.910, 180.930, and 180.940(a) for di-n-butyl carbonate (CAS Reg. No. 542-52-9) when used as an inert ingredient (solvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals, and when used as an inert ingredient in antimicrobial formulations in food-contact surface sanitizer products at a maximum level in the end-use concentration of 15,000 ppm.

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

This 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:

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-2014-0161 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 14, 2015. 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-2014-0161, 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 May 23, 2014 (79 FR 29729) (FRL-9910-29), 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 4E8239) by Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road East, Suite 201 W, Princeton, NJ 08540. The petition requested that 40 CFR 180.412 be amended by establishing tolerances for combined residues of the herbicide sethoxydim 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one and its metabolites containing the 2-cyclohexen-1-one moiety (calculated as the herbicide sethoxydim) in or on raw agricultural commodities (RACs): Bushberry subgroup 13-07B at 5.0 parts per million (ppm); caneberry subgroup 13-07A at 5.0 ppm; berry, low growing subgroup 13-07H, except strawberry at 2.5 ppm; fescue forage at 6.0 ppm; fescue, hay at 4.0 ppm; fruit, citrus group 10-10 at 0.5 ppm; fruit, pome group 11-10 at 0.2 ppm; fruit, small, vine climbing subgroup 13-07F, except fuzzy kiwifruit at 1.0 ppm; rapeseed subgroup 20A at 35 ppm; sunflower subgroup 20B, except safflower, seed at 7.0 ppm; cottonseed subgroup 20C at 5.0 ppm; vegetable, bulb group 3-07 at 1.0 ppm; and vegetable, fruiting group 8-10 at 4.0 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. One comment was received on the notice of filing. EPA's response to this comment is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has made certain modifications, including revising certain petitioned-for tolerance levels, setting meal tolerances for various oilseed crop subgroups to cover potential processed commodities, and updating crop definitions as well as the tolerance expression for sethoxydim to conform to current EPA policies. The reasons for these changes are explained in Unit IV.D.

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 sethoxydim including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with sethoxydim follows.

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

Toxicological tests in animals (rats, mice, and dog) show that the target organ of sethodydim toxicity is the liver. Toxic effects are characterized by increased liver weight; hypertrophy; fatty degeneration; hepatocyte swelling; increased serum bilirubin, alkaline phosphatase, aspartate aminotransferase, and alanine aminotransferase levels; focal granulomatous inflammation; and eosinophilic foci. Liver toxicity was observed by exposure through both the oral and inhalation routes.

Findings other than liver toxicity were also observed. In a subchronic rat study, decreased body weight, body weight gain, and food efficiency were noted at a lower dose than liver toxicity. In a chronic dog toxicity study, increased hemosiderosis in the spleen and depressed myeloid erythropoiesis in the sternal bone marrow were observed. Interstitial fibrosis and heart failure cells in lung in female rats were observed in the chronic toxicity/carcinogenicity study in rats.

In the developmental rat study, maternal toxicity was observed, as evidenced by an irregular gait, decreased activity, excessive salivation, and anogenital staining at a dose greater than half the limit dose and at the limit dose. All clinical signs reported were transient, with the exception of the anogenital staining, which did not reverse.

Developmental toxicity occurred at the same dose as maternal toxicity in rats and included decreased fetal weights, filamentous tail, and lack of tail due to the absence of sacral and/or caudal vertebrae, and delayed ossification in the hyoids, vertebral centrum and/or transverse processes, sternebrae and/or metatarsals, and pubes. No maternal toxicity was noted in rabbits at 400 milligrams per kilogram (mg/kg)/day, and developmental toxicity was noted at 400 mg/kg/day (NOAEL = 320 mg/kg/day) as an increase in the incidence of incompletely ossified 6th sternebrae. In the reproduction study, no parental or reproductive toxicity was observed at 150 mg/kg/day (highest dose tested), but offspring toxicity was noted at this dose as decreased pup weight in the F1a, F1b, and F2b generation during lactation (no-observed-adverse-effect-level (NOAEL) = 30 mg/kg/day). There is a low concern for these findings, since the selected points of departure are protective; there is low concern for pre- and/or postnatal toxicity resulting from exposure to sethoxydim.

Dermal toxicity was not observed at the limit dose in a 21-day dermal study in rabbits. Based on the lack of sensitization in treated guinea pigs, sethoxydim is not a skin sensitizer. No eye or dermal irritation were noted in rabbits. No neurotoxicity or other toxicity was observed at the highest dose tested (207 mg/kg/day) in the subchronic neurotoxicity test in rats.

There was no evidence of carcinogenicity in rats and mice, and no evidence of genotoxicity. Sethoxydim is classified as “Not Likely to Be Carcinogenic to Humans.” Specific information on the studies received and the nature of the adverse effects caused by sethoxydim, as well as the NOAEL and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies, can be found at http://www.regulations.gov in document “Sethoxydim: Human Health Risk Assessment for Registration Review and to Support the Section 3 Registration of Proposed Uses on High Bush Blueberry and Fine Fescue Grasses”, dated February 3, 2015 at page 40 in docket ID number EPA-HQ-OPP-2014-0161-000x.

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

A summary of the toxicological endpoints for sethoxydim 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 sethoxydim, EPA considered exposure under the petitioned-for tolerances as well as all existing sethoxydim tolerances in 40 CFR 180.412. EPA assessed dietary exposures from sethoxydim 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 sethoxydim. In conducting the acute dietary exposure assessment for sethoxydim, EPA used the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This software uses 2003-2008 food consumption data from the U.S. Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). A partially refined acute analysis was performed based on tolerance-level residues; percent crop treated (PCT) estimates for most agricultural uses of sethoxydim were applied, and DEEM TM default processing factors were applied to account for processed commodities.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment for sethoxydim, EPA used DEEM-FCID Version 3.16 in which the software uses 2003-2008 food consumption data from the USDA's NHANES/WWEIA. A partially refined chronic dietary exposure assessment was conducted, which used PCT data, but the overall dietary assessment represents high-end exposure because tolerance-level residues were used for food and bounding modeled residues for drinking water. Anticipated residues (based on maximum theoretical diets) were used for livestock commodities.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that sethoxydim is not likely to 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. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such data call-ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

Section 408(b)(2)(F) of FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if:

• Condition a: The data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain the pesticide residue.

• Condition b: The exposure estimate does not underestimate exposure for any significant subpopulation group.

• Condition c: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

The Agency estimated the PCT for existing uses. For acute dietary risk assessment for sethoxydim the following maximum PCT estimates were used: Alfalfa 2.5%; almonds 5%; apples 2.5%; apricots 10%; artichokes 2.5%; asparagus 10%; beans, green 15%; blueberries 10%; broccoli 5%; cabbage 10%; caneberries 10%; canola 2.5%; cantaloupes 25%; carrots 5%; cauliflower 10%; celery 2.5%; cherries 2.5%; corn 2.5%; cotton 2.5%; cucumbers 10%; dry beans/peas 35%; eggplant 10%; fallow 2.5%; garlic 5%; grapefruit 2.5%; grapes 5%; hazelnuts 2.5%; lettuce 10%; oats 2.5%; onions 15%; oranges 5%; peaches 2.5%; peanuts 10%; pears 2.5%; peas, green 15%; pecans 2.5%; peppers 15%; pistachios 2.5%; plums/prunes 2.5%; potatoes 5%; pumpkins 10%; soybeans 2.5%; spinach 2.5%; squash 10%; strawberries 10%; sugar beets 5%; sunflowers 10%; sweet corn 5%; tobacco 10%; tomatoes 5%; walnuts 5%; watermelons 20%; wheat 2.5%.

For chronic dietary risk assessment, the following average PCT estimates for sethoxydim were used: Alfalfa 1%; almonds 2.5%; apples 1%; apricots 2.5%; artichokes 2.5%; asparagus 5%; beans, green 10%; blueberries 5%; broccoli 2.5%; cabbage 5%; caneberries 5%; canola 2.5%; cantaloupes 5%; carrots 2.5%; cauliflower 5%; celery 2.5%; cherries 2.5%; corn 1%; cotton 1%; cucumbers 5%; dry beans/peas 30%; eggplant 5%; fallow 1%; garlic 2.5%; grapefruit 2.5%; grapes 2.5%; hazelnuts 2.5%; lettuce 2.5%; oats 1%; onions 5%; oranges 2.5%; peaches 1%; peanuts 5%; pears 2.5%; peas, green 5%; pecans 2.5%; peppers 5%; pistachios 1%; plums/prunes 1%; potatoes 2.5%; pumpkins 5%; soybeans 1%; spinach 2.5%; squash 5%; strawberries 2.5%; sugar beets 2.5%; sunflowers 5%; sweet corn 2.5%; tobacco 5%; tomatoes 2.5%; walnuts 2.5%; watermelons 10%; wheat 1%.

In most cases, EPA uses available data from United States Department of Agriculture/National Agricultural Statistics Service (USDA/NASS), proprietary market surveys, and the National Pesticide Use Database for the chemical/crop combination for the most recent 6-7 years. EPA uses an average PCT for chronic dietary risk analysis. The average PCT figure for each existing use is derived by combining available public and private market survey data for that use, averaging across all observations, and rounding to the nearest 5%, except for those situations in which the average PCT is less than one. In those cases, 1% is used as the average PCT and 2.5% is used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk analysis. The maximum PCT figure is the highest observed maximum value reported within the recent 6 years of available public and private market survey data for the existing use and rounded up to the nearest multiple of 5%.

The Agency believes that the three conditions discussed in Unit III.C.1.iv. have been met. With respect to Condition a, PCT estimates are derived from Federal and private market survey data, which are reliable and have a valid basis. The Agency is reasonably certain that the percentage of the food treated is not likely to be an underestimation. As to Conditions b and c, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer-based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available reliable information on the regional consumption of food to which Sethoxydim may be applied in a particular area.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for sethoxydim in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of sethoxydim. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm.

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) Surface Water Calculator (SWCC Version 1.106), Surface Water Provisional Cranberry Model and Tier 1 mode of the Pesticide Root Zone Model Ground Water (PRZM GW), the estimated drinking water concentrations (EDWCs) of sethoxydim for acute exposures are estimated to be 79.6 parts per billion (ppb) for surface water and 0.565 ppb for ground water.

For chronic exposures for non-cancer assessments are estimated to be 13.9 ppb for surface water and 0.51 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 79.6 ppb was used to assess the contribution to drinking water.

For chronic dietary risk assessment, the water concentration of value 13.9 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).

Sethoxydim is currently registered for the following uses that could result in residential exposures: Turf (including lawns, golf courses, recreational parks, and sod farms) and ornamentals. Short-term exposure to sethoxydim may occur via the dermal and inhalation routes for adults using sethoxydim products in residential settings. Since no dermal hazard was identified, only inhalation exposures were assessed for residential applicators. In addition, children may potentially be exposed orally in post-application turf scenarios. Intermediate- or long-term exposures are not expected due to the intermittent nature of applications by homeowners.

EPA assessed residential exposure using the following assumptions: Since no dermal hazard was identified in the toxicity database for sethoxydim, a quantitative residential post-application dermal risk assessment is not required and was not completed. Post-application inhalation exposures while performing activities in previously treated turf or ornamentals are not expected, primarily due to the very low vapor pressure (1.6 × 10−7 mm Hg at 25 °C) and the expected dilution in outdoor air after an application has occurred. Therefore, post-application inhalation exposures were not assessed. The residential post-application assessment considers non-dietary incidental oral exposures only. Residential post-application exposures are generally considered to be intermittent and short-term in duration.

For the residential turf use scenario, post-application incidental oral exposure is assessed for children (1 to < 2 years old as the sentinel population). The turf use site assessed was residential lawn turf as exposures from that use are expected to be higher than any potential exposures from other turf uses (i.e., recreational parks, golf courses, or treated sod). The assessment was conducted assuming the maximum application rate (0.47 lbs ai/acre) and used unit exposure values and estimates for area treated or amount handled.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.

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

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

2. Prenatal and postnatal sensitivity. There is evidence of increased susceptibility of the young following exposure to sethoxydim in the rat and/or rabbit developmental and reproduction studies. To further assess these effects, the EPA performed a Degree of Concern Analysis in which sethoxydim was evaluated for potential developmental effects in the rat and rabbit. Maternal toxicity included transient clinical signs (irregular gait, decreased activity, excessive salivation, and anogenital staining) in rats at 650 mg/kg/day and at the limit dose. Decreased fetal body weight, delayed ossification, and malformations (filamentous tail; lack of tail) were observed in the rat at 650 mg/kg/day and at the limit dose. Maternal toxicity was not observed in rabbits, whereas an increased incidence of incompletely ossified 6th sternebrae was noted in fetuses at the high dose (400 mg/kg/day). Decreased body weight was observed in F1a, F1b, and F2b pups during lactation in the 2-generation reproduction study at 150 mg/kg/day (highest dose tested), while parental toxicity was not observed. The Agency concluded from the Degree of Concern Analysis that there was low concern for pre- and/or post-natal toxicity resulting from exposure to sethoxydim, because the chosen points of departure for risk assessment for each exposure scenario are protective for these effects.

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

i. The toxicity database for sethoxydim is complete.

ii. There was no clear evidence of neurotoxicity or neuropathology in the available studies, which include a subchronic neurotoxicity study. The acute neurotoxicity study and developmental neurotoxicity study requirements have been waived.

iii. There is evidence that sethoxydim results in increased susceptibility in in utero exposure to sethoxydim in the rabbit developmental toxicity study and following in utero and/or pre-/post-natal exposure in the 2-generation reproduction study in rats. However, there is low concern because the chosen points of departure for risk assessment for each exposure scenario are protective for these effects.

iv. There are no residual uncertainties identified in the exposure databases. The dietary exposure estimates were partially refined by incorporation of percent of crop treated assumptions; however, tolerance-level residue in food and upper-bound drinking water estimates based on modeling were used which are conservative assumptions. EPA used similarly conservative assumptions to assess post-application exposure of children, as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by sethoxydim.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions described in this unit for acute exposure, acute dietary risk estimates for the registered and proposed uses of sethoxydim will occupy 5.4% of the aPAD for the general U.S. population. The risk estimate for the most highly exposed subgroup, children 1-2 year old, was 8.6% of the aPAD.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to sethoxydim from food and water will utilize 27% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of sethoxydim is not expected.

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

Sethoxydim is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to sethoxydim. The short-term aggregate assessment for children 1-2 years old, the most exposed subpopulation group, includes post-application oral residential exposures from treated turf and chronic dietary exposure.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 4,000 that are below the EPA's level of concern for sethoxydim.

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

Because there is no intermediate-term exposure, sethoxydim is not expected to pose an intermediate-term risk.

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

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

An adequate gas chromatography/flame photometric detection GC/FPD method is available (Method I in PAM Vol. II) for determining the combined residues of sethoxydim and its metabolites containing the 3-alkyl substituted pentanedioic acid moiety in plant and livestock commodities which provides a 0.05 ppm limit of quantitation (LOQ).

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.

There are no Codex MRLs established for the residues of sethoxydim in/on raw agricultural or processed commodities.

One comment was received from a private citizen objecting to establishment of petitioned-for tolerances for residues of sethoxydim and a number of other pesticides on food items as these are “dangerous chemicals” and children are disproportionately exposed to health risks from their use. In addition, the commenter expressed concern about the potential for increased cancer rates in children due to pesticide exposures. The Agency understands the commenters' concerns regarding chemicals and their potential effects on humans. Pursuant to its authority under the FFDCA, and as discussed further in this preamble, EPA conducted a comprehensive assessment of sethoxydim, which included an assessment on the carcinogenic potential of sethoxydim. Based on its assessment of the available data, EPA has found that there is a reasonable certainty of no harm to humans, with special emphases on infants and children sensitivity, from aggregate exposure to sethoxydim based on a complete toxicological database and the potential exposure levels.

The tolerance for the bushberry subgroup 13-07B is based on the residue data on blueberry, the representative crop at 4.0 ppm and not the previously established tolerances for juneberry, lingonberry, and salal at 5.0 ppm. The juneberry, lingonberry, and salal tolerances were based on the translation of caneberry data, which are no longer relevant to these crops following updated crop grouping realignment. Moreover, EPA has determined that available data support a reduction in sethoxydim residue tolerance level for these crops from 5.0 ppm to 4.0 ppm.

Based on available data and the application of the OECD calculation procedures, EPA is establishing a tolerance of 7.0 ppm for fescue, forage, rather than 6.0 ppm as requested by the petitioner. This difference stems from the conclusion that only 4 independent grass trials were conducted instead of 5 (as assumed by IR-4).

In addition, for the requested rapeseed subgroup 20A and sunflower subgroup 20B crop group conversions, each RAC could potentially be processed into meal. Therefore, following the established meal tolerance of the representative crop, canola meal at 40 ppm for subgroup 20A and sunflower meal at 20 ppm for subgroup 20B, tolerances for the residues of sethoxydim are also required for translation to the following commodities: Calendula, meal at 20 ppm; castor oil plant, meal at 20 ppm; Chinese tallowtree, meal at 20 ppm; cuphea, meal at 40 ppm; echium, meal 40 ppm; euphoriba, meal at 20 ppm; evening primrose, meal at 20 ppm; flax seed, meal at 40 ppm; hare's ear mustard, meal at 40 ppm; jojoba, meal at 20 ppm; lesquerella, meal at 40 ppm; lunaria, meal at 40 ppm; meadowfoam, meal at 40 ppm; milkweed, meal at 40 ppm; mustard, meal at 40 ppm; niger seed, meal at 20 ppm; oil radish, meal at 40 ppm; poppy seed, meal at 40 ppm; rose hip, meal at 20 ppm; sesame, meal at 40 ppm; stokes aster, meal at 20 ppm; sweet rocket, meal at 40 ppm; tallowwood, meal at 20 ppm; tea oil plant, meal at 20 ppm; and vernonia, meal at 20 ppm. Additionally, an existing borage, meal tolerance at 10 ppm is being raised to 40 ppm.

Lastly, the Agency is updating the tolerance expressions for sethoxydim as follows to reflect current EPA policies: Tolerances are established for the herbicide sethoxydim, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-2) and its metabolites containing the 2-cyclohexen-1-one moiety, calculated as the stoichiometric equivalent of sethoxydim, in or on the commodities listed in the subsections.

Establishing a tolerance at 4.0 ppm for the expanded crop subgroup 13-07B results in reductions of the existing sethoxydim tolerance level for juneberry, lingonberry, and salal, which are each set individually at 5.0 ppm. In order to allow a reasonable interval for producers in the exporting member countries of the World Trade Organization's Sanitary and Phytosanitary Measures Agreement to adapt to the requirements of these modified tolerances, EPA is establishing an expiration date for those higher individual tolerances (for juneberry, lingonberry, and salal) of December 15, 2015. Those tolerances will remain in place for six months after the publication of this rule—and residues of sethoxydim may be present on juneberry, lingonberry, and salal at levels up to 5.0 ppm until their expiration date—in order to allow a reasonable interval for producers in exporting member countries to adapt to the reduced tolerances. After that 6-month period, those individual tolerances will expire, and residues of sethoxydim on juneberry, lingonberry, and salal will need to comply with the bushberry subgroup 13-07B tolerance, which includes those commodities and limits residues to 4.0 ppm.

Tolerances are established for the herbicide sethoxydim, including its metabolites and degradates, in or on the commodities listed below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of the herbicide 2-[1-(ethoxyimino)butyl]-5-[2-(ethylthio)propyl]-3-hydroxy-2-cyclohexen-1-one (CAS Reg. No. 74051-80-2) and its metabolites containing the 2-cyclohexen-1-one moiety, calculated as the stoichiometric equivalent of sethoxydim, in or on commodities: Berry, low growing, subgroup 13-07H, except strawberry at 2.5 ppm; borage, meal at 40 ppm; bushberry, subgroup 13-07B at 4.0 ppm; calendula, meal at 20 ppm; caneberry, subgroup 13-07A at 5.0 ppm; castor oil plant, meal at 20 ppm; Chinese tallowtree, meal at 20 ppm; cottonseed, subgroup 20C at 5.0 ppm; cuphea, meal at 40 ppm; echium, meal 40 ppm; euphorbia, meal at 20 ppm; evening primrose, meal at 20 ppm; fescue, forage at 7.0 ppm; fescue, hay at 4.0 ppm; flax seed, meal at 40 ppm; fruit, citrus, group 10-10 at 0.5 ppm; fruit, pome, group 11-10 at 0.2 ppm; fruit, small, vine climbing, subgroup 13-07F, except fuzzy kiwifruit at 1.0 ppm; hare's ear mustard, meal at 40 ppm; jojoba, meal at 20 ppm; lesquerella, meal at 40 ppm; lunaria, meal at 40 ppm; meadowfoam, meal at 40 ppm; milkweed, meal at 40 ppm; mustard, meal at 40 ppm; niger seed, meal at 20 ppm; oil radish, meal at 40 ppm; poppy seed, meal at 40 ppm; rapeseed, subgroup 20A at 35 ppm; rose hip, meal at 20 ppm; sesame, meal at 40 ppm; stokes aster, meal at 20 ppm; sunflower subgroup 20B, except safflower at 7.0 ppm; sweet rocket, meal at 40 ppm; tallowwood, meal at 20 ppm; tea oil plant, meal at 20 ppm; vegetable, bulb, group 3-07 at 1.0 ppm; vegetable, fruiting, group 8-10 to 4.0 ppm; and vernonia, meal at 20 ppm. In addition, upon establishment of the above tolerances, remove the following entries that are superseded by this action including: Blueberry; borage, seed; caneberry subgroup 13A; canola, seed; cotton, undelinted seed; crambe, seed; cranberry; cuphea, seed; echium, seed; flax, seed; fruit, citrus group 10; fruit, pome, group 11; gold of pleasure, seed; grape; hare's ear mustard, seed; lesquerella, seed; lunaria, seed; meadowfoam, seed; milkweed, seed; mustard, seed; oil radish, seed; okra; poppy, seed; rapeseed, seed; sesame, seed; sunflower, seed; sweet rocket, seed; vegetable, bulb group 3; and vegetable, fruiting group 8.

Finally, the individual tolerances for juneberry, lingonberry, and salal at 5.0 ppm will expire 6 months from the date of publication of this final rule in the Federal Register.

This action establishes tolerances 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 tolerances 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: