Regulatory Certifications Executive Orders

This document does not meet the criteria for a significant regulatory action as specified by E.O. 12866. This action also has no federalism or tribal implications, and will not impose substantial unreimbursed compliance costs on States, local governments, or Indian tribal governments. Therefore, impact statements are not required under E.O. 13132 or 13175.

The Regulatory Flexibility Act is not applicable to this rule because neither the Secretary of Agriculture nor NRCS is required by 5 U.S.C. 553 or any other law to publish a notice of proposed rulemaking for the subject matter of this rule.

This rule will have no significant effect on the human environment and is categorically exempt under 7 CFR 1b.3(a)(6); therefore, neither an environmental assessment nor an environmental impact statement is required.

This rule does not contain reporting or recordkeeping requirements subject to the Paperwork Reduction Act.

Existing wetland conservation provisions in 7 CFR part 12 require that NRCS' certification of a wetland determination be completed according to procedures agreed to by the Army Corps of Engineers (COE), the Environmental Protection Agency (EPA), and the U.S. Fish and Wildlife Service. In 1994, the Departments of Agriculture and the Interior, the Army, and the Environmental Protection Agency entered into a Memorandum of Agreement (MOA) concerning the delineation of wetlands for purposes of Section 404 of the Clean Water Act (CWA) and Title XII of the Food Security Act of 1985 (FSA). The MOA was developed to streamline the wetland delineation process on agricultural lands, to promote consistency between the CWA and the FSA, and to provide predictability and simplification for USDA program participants. However, subsequent amendments to FSA and court decisions made the MOA and parts of 7 CFR 12.30 no longer applicable, and USDA and COE withdrew from the MOA in January 2005.

1996 amendments to FSA eliminated the concept of “abandonment” for prior converted (PC) cropland. As a result, land may be considered non-wetland for FSA compliance purposes, but considered wetland for CWA purposes. 2002 amendments to FSA prohibit NRCS from sharing confidential producer information, including geospatial information, to agencies outside USDA. This prohibits NRCS from providing wetland delineations and determinations to the COE and EPA for CWA permitting and enforcement. Finally, as a result of U.S. Supreme Court decisions, a wetland may be subject to FSA Compliance, but no longer regulated by the COE for CWA purposes. These inconsistencies in jurisdiction do not allow the two agencies to have consistent wetland determinations.

For the reasons stated in the preamble, USDA amends part 12 of Title 7 of the Code of Federal Regulations as set forth below:

The Reauthorization Act (Pub. L. 108-265; June 30, 2004) phased-in mandatory direct certification provisions with the Food Stamp Program  1 and made children participating in certain other programs categorically eligible for free school meals. In order to provide readers with a chronological account of direct certification, this preamble begins with a history of direct certification which includes a discussion of the relevant changes made in the Reauthorization Act. These amendments are intended to streamline the certification and verification processes by reducing paperwork for both program administrators and households by eliminating the need for submission of free and reduced priced meal applications by these households.

This rule is being issued as an interim rule as authorized by section 501(b) of the Reauthorization Act and because of the specific implementation dates therein. The Reauthorization Act also required that regulations be promulgated within two years of enactment which was 2006. In order to accommodate the statutory deadlines imposed for fully phasing-in direct certification with SNAP and to provide access to free meals to children newly added as categorically eligible, the Department implemented the non-discretionary provisions in the Reauthorization Act through guidance as discussed below. In addition, by issuing the guidance, the Department complied with the implementation requirements established in 501(a) of the Reauthorization Act. The delay in issuing this interim rule enabled the Department to develop it using data from the direct certification reports to Congress as well as address issues raised by State and local agencies about the direct certification process as implemented. The Department strongly supports providing any opportunity for public comment from interested parties, which is afforded through the interim rule process. Changes resulting from comments and from experience based on the interim rule would be implemented through a future final rule.

Until 1981 to receive free and reduced price meals or free milk for their children, households were required by statute to complete an application for free or reduced price meals or for free milk, providing income and household size information. The Omnibus Budget Reconciliation Act of 1981, Public Law 97-35, amended the Richard B. Russell National School Lunch Act (NSLA)  2 to include a number of changes to the free and reduced price meal eligibility process. One of those changes allowed submission of documentation showing participation in the Food Stamp Program. This was implemented by permitting households certified to receive benefits under the Food Stamp Program to provide their case number to schools in lieu of completing income information on the free and reduced price meal application. Thus, children who are members of households certified to receive food stamp benefits are “categorically eligible” for free school meals.

The School Lunch and Child Nutrition Amendments of 1986, Public Law 99-661, made further amendments to the NSLA to mandate categorical eligibility for free meals and a simplified verification of eligibility process for children in food stamp households and children in Aid to Families with Dependent Children (AFDC)  3 assistance units. Since the regulations had already been amended to allow simplified application and verification procedures for food stamp households, the regulations were revised to extend these provisions to AFDC households.

The Child Nutrition and WIC Reauthorization Act of 1989, Public Law 101-147, again amended the NSLA to respond to concerns expressed by program operators regarding the volume of paperwork associated with the Child Nutrition Programs. The NSLA authorized school officials to certify children eligible for free meals, without further application, based on documentation obtained directly from the appropriate State or local agency that the children are part of households receiving assistance under the Food Stamp Program or AFDC Program. This certification process is commonly referred to as “direct certification.”

Because the Food Distribution Program on Indian Reservations (FDPIR) is authorized by section 4 of the Food and Nutrition Act of 2008, 7 U.S.C. 2013, the same law authorizing SNAP, formerly the Food Stamp Program, and because eligible households on and near reservations have the option of participating in either SNAP or FDPIR, the Department extended the provisions on categorical eligibility and direct certification to include FDPIR households.

In 2004, the Reauthorization Act made several amendments to the NSLA to improve the integrity of the free and reduced price meal certification and verification processes, without hindering access of low-income children. Section 104 of the Reauthorization Act added section 9(b)(4) to the NSLA, 42 U.S.C. 1758(b)(4) to require local educational agencies to directly certify, without further application, any child who is a member of a household receiving benefits under SNAP. To facilitate this requirement, an agreement between the State agency administering SNAP and the State agency or agencies administering the school meals programs is required. The required direct certification with SNAP is in addition to the previous and still existing optional authority for direct certification with TANF and FDPIR.

In accordance with the Reauthorization Act, the requirement to directly certify children receiving benefits under SNAP was phased-in based on the enrollment of the local educational agency as follows—

In addition, the 2004 Reauthorization Act included provisions making children who are homeless, runaway, or migratory, as determined by the homeless coordinator for homeless or runaway children or by officials of the Migrant Education Program (MEP) for migratory children, categorically eligible for free meals, effective July 1, 2004. To ensure that the affected children could access free meal benefits as quickly as possible, the Department issued guidance to implement these statutory provisions. The pertinent memoranda are:

• July 19, 2004—Categorical Eligibility for Free Lunches and Breakfasts of Runaway, Homeless, and Migrant Youth: Reauthorization 2004 Implementation Memo SP 4;

• August 16, 2004—Categorical Eligibility for Free Lunches and Breakfasts for Migrant Children; and

• September 17, 2004—Guidance on Determining Categorical Eligibility for Free Lunches and Breakfasts for Youth Served under the Runaway and Homeless Youth Act.

Because of the benefits of direct certification relating to improving access and reducing paperwork, the Department felt that is was important to determine both the number of local educational agencies that were doing direct certification and what percentage of the total number of children eligible for free and reduced meals they represented. Studies and surveys conducted by FNS have indicated that, prior to School Year 2007-2008, a little more than 60 percent of local educational agencies were using direct certification. Please note that the majority of these studies were conducted prior to mandatory direct certification with SNAP. This data has given FNS a baseline to measure the success of mandatory direct certification with SNAP. Data for School Year 2009-2010 showed that 83 percent of local educational agencies conduct direct certification. Studies and sources include—

“Analysis of Verification Summary Data SY2004-05” (May 2006) which may be found at http://www.fns.usda.gov/oane/menu/Published/CNP/FILES/CNVerification.pdf;

“Preliminary Report on the Feasibility of Computer Matching in the National School Lunch Program” (January 2005) which may be found at http://www.fns.usda.gov/oane/menu/Published/CNP/FILES/NSLPDataMatch.pdf;

“Direct Certification in the National School Lunch Program—Impacts on Program Access and Integrity Study of Direct Certification in the National School Lunch Program” (October 2003, Economic Research Service, USDA, contracted study) which may be found at http://www.ers.usda.gov/Publications/EFAN03009;

“Study of Direct Certification in the National School Lunch Program” (September 2000) which may be found at http://www.fns.usda.gov/oane/menu/Published/CNP/FILES/directcert.pdf; and

“Direct Certification in the National School Lunch Program: State Implementation Progress Report to Congress” (December 2008) found at http://www.fns.usda.gov/oane/menu/Published/CNP/FILES/DirectCert08.pdf.

“Direct Certification in the National School Lunch Program: State Implementation Progress Report to Congress—October 2009” found at http://www.fns.usda.gov/ora/MENU/Published/CNP/FILES/NSLPDirectCertification2009.pdf.

“Direct Certification in the National School Lunch Program: State Implementation Progress School Year 2009-2010” found at http://www.fns.usda.gov/ora/menu/Published/CNP/FILES/DirectCert2010.pdf.

The studies cited in section II indicated that the methods commonly used for direct certification involve matching and non-matching processes. In the non-matching method, the States' assistance agencies generate lists or databases of TANF and SNAP households with school age children. The assistance agencies use the lists/databases to send households a letter that includes the necessary direct certification documentation. The letter instructs the household to provide the letter to the school if they want free meals or milk for their children. Children in households that provide the letters to the school or local educational agency are certified eligible for free meals or milk based on this documentation. This procedure is considered the “letter method.”

In the matching method, the State assistance agency databases/lists of SNAP or TANF households with school age children are matched at the State or local educational agency level against student enrollment databases or lists. Most systems involve a matching of two or three identifiers, such as the children's names and birth dates and/or addresses. Matching at the State level is generally automated, while matching at the local educational agency level may be a manual process, especially in smaller districts or those districts with fewer families receiving benefits from SNAP, TANF or FDPIR. Once eligible children have been identified through direct certification, their parents or guardians are notified, in writing by the local educational agency, that their children are eligible to receive free meals without any additional application. Further, these households are not subject to verification since the local educational agency has already documented that the child is a member of a household receiving other programs' benefits.

Typically, direct certification is conducted at or around the beginning of the school year. However, a number of States and local educational agencies have the capability of doing direct certification more frequently, on a monthly or even daily basis.

Households receiving assistance from SNAP, TANF or FDPIR may also submit an application with their case number(s) for the child(ren) on the free and reduced price meal or free milk application to establish their categorical eligibility for free meals or milk. The only other information needed on the application is each child's name and the signature of an adult household member. Should the application be selected for verification of eligibility, the household must submit proof of participation in SNAP, TANF or FDPIR in order to continue program participation.

All participating NSLP and School Breakfast Program (SBP) schools, including public and private non-profit schools and residential child care institutions (RCCIs), must implement the mandatory direct certification provisions for children who are members of households receiving benefits from the SNAP. RCCIs that operate a day school must conduct direct certification for day students. However, RCCIs that only have residential students are exempted from this requirement. Residential students would not receive SNAP benefits since they are residing in an institution. This exemption is found in this interim rule at paragraph 245.6(b)(1)(ii).

The administering entity for the private schools or RCCIs should contact their State agency to work out the logistics for obtaining information from the agency administering SNAP about the children enrolled in their schools. Please note when determining claiming percentages for Provision 2 or Provision 3, which are the special assistance certification and reimbursement alternatives permitted in § 245.9, direct certification is required only in base years. This provision may be found at paragraph 245.6(b)(1)(v).

As indicated earlier, the NSLA requires that all children in households receiving SNAP benefits be directly certified for free meals and paragraph 245.6(b) is amended by this rule to address mandatory direct certification of children receiving benefits from SNAP.

Because direct certification is a useful tool for schools and reduces paperwork and increases participation, the Department's ultimate goal for direct certification is for State and local educational agencies to have the capability to conduct on-going direct certification with SNAP, TANF and FDPIR through computer matching that provides the most current information about households receiving benefits from those programs. Once an on-going system becomes operational, the local educational agency would be able to promptly determine when children who were not already certified for free meal benefits become eligible, based on membership in a household recently approved for benefits from SNAP, TANF or FDPIR. The eligibility of children previously directly certified is not affected by more frequent direct certification because, once eligibility is established, it is in effect for the entire school year and up to thirty (30) operating days in the following school year.

To this end, this interim rule requires that local educational agencies conduct direct certification with SNAP at least three times during the school year (July 1 to June 30) beginning no later than School Year 2011-2012. This increased number of matching efforts has the potential to facilitate participation of children in the school meals programs. Of course, more frequent direct certification efforts are permissible and encouraged.

The efforts must be made at or around the beginning of the school year; three months after the beginning of the school year; and six months after the beginning of the school year. For example, if the school classes begin on August 15th, the initial direct certification effort would be in July or August; the second would be in October or November and the last in January or February. Direct certification efforts are required for children who were not initially directly certified and who are currently reduced price or paid. If the local educational agency has the capability, the status of any newly enrolled child must be checked for SNAP eligibility at the time of enrollment. If this is not possible, the household must be provided with an application so that the child's benefits are not delayed until the next scheduled direct certification update.

Any newly eligible children identified in matches made subsequent to the beginning of the school year must be certified for free meals and the local educational agency must promptly notify their parents or guardians in writing of the new status. This includes children who had been certified for reduced price meals but who are subsequently identified as receiving SNAP benefits. The requirement for the frequency of direct certification efforts with SNAP is found at paragraph 245.6(b)(3) of this interim rule. Please note direct certification with FDPIR and TANF remains optional. The authority for direct certification with FDPIR or TANF is found at paragraph 245.6(b)(2).

As discussed earlier, some State and local SNAP or other assistance agencies currently provide letters to households as their method of direct certification. The household takes the letter indicating its receipt of SNAP benefits to the local educational agency in lieu of an application. Studies show that states have been able to improve the effectiveness of their direct certification process by changing from the letter method to an electronic matching approach. Further, since the original availability of direct certification in the early 1990s, sharing information between SNAP and other assistance agencies and State/local educational agencies has become easier and more cost effective.

A 2007 study, Data Matching in the National School Lunch Program: 2005 Volume 1: Final Report, available at http://www.fns.usda.gov/oane/menu/Published/CNP/FILES/DataMatching-V1.pdf. discussed the effectiveness of the various direct certification methods. This study showed that States with mandatory statewide State-level matching had the highest rates of direct certification, with 74 percent of categorically certified children directly certified. The letter method resulted in a significantly lower rate of direct certification, with only 52 percent of categorically certified children.

Therefore, this interim rule requires, at paragraph 245.6(b)(1)(iii), that, in School Year 2011-2012, all State agencies phase out the letter method as their method for direct certification with SNAP. And for School Year 2012-2013, the letter method can no longer be used to conduct direct certification. This provision is consistent with the requirement in the Healthy, Hunger-Free Kids Act of 2010 (Pub. L. 111-296; December 13, 2010). All State agencies must have a method to exchange eligibility information from SNAP more directly with the local educational agency through some type of automated data-matching process. Currently, there are a range of systems in use. However, State and local agencies may continue to provide letters to families as a secondary method along with use of automated system, especially during the initial use of an automated system. The additional notification to families would help to ensure that they were aware of their children's categorical eligibility.

Please note that the use of the letter method only as a secondary method of identifying categorical eligibility only applies to SNAP. The letter method may continue to be used as the primary method for other sources of categorical eligibility.

Section 9(b)(12) of the NSLA provides for categorical eligibility for children who are members of households receiving assistance from SNAP, FDPIR, and TANF. The implementing regulations required that a child be a member of the household as determined by the assistance program in order to be categorically eligible for free school meals. For direct certification, this has been an individual match. For applications, each child had to have a case number listed in order to be categorically eligible. For consistency, we did not extend categorical eligibility to newly enrolled siblings in the subsequent school year.

We have heard from various program operators and other stakeholders that this interpretation is problematic administratively and unnecessarily omits eligible children from the direct certification process. For direct certification, school-age children from the same household who are not identified through the match are most likely receiving SNAP or other benefits but are not matched because of minor differences in the identifying information used in the match.

Individual eligibility also results in households with some children directly certified and others for whom an application must be submitted. If some of the children in the family are directly certified, the family may not realize until after school starts that an application is needed for their other children. This sometimes requires the family to pay for meals for the uncertified children until the application is submitted and approved.

For local educational agencies, maintaining different types of eligibility for direct certification and application-based records for the same household may be difficult. It also complicates reporting and may result in misleading information for determining verification sample sizes and other purposes.

Therefore, under this interim rule, if one or more children in the household is also a member of a family receiving assistance under SNAP, FDPIR or TANF, all school-aged children in the household are considered categorically eligible for free meals or free milk. This applies for both direct certification and applications with case numbers. The local educational agency must extend eligibility for free meals to all children that can be identified as members of a household on an application for free or reduced price meals or free milk. If the local educational agency does not have a prior application to refer to, school district enrollment records are acceptable to determine if there any additional children in the household who were not directly certified. For households submitting applications with case numbers for some children, the local educational agency must certify all children as categorically eligible for free meals and disregard income information. This requirement is found at § 245.2 (definition of “Documentation”), paragraph 245.6(b)(7) and paragraph 245.6(c)(5).

To facilitate mandatory direct certification of children receiving benefits from SNAP, the NSLA requires, at section 9(b)(4)(A), 42 U.S.C. 1758 (b)(4)(A), that the State agency responsible for administering SNAP and the State agency responsible for administering the school meals programs enter into an agreement to facilitate the mandatory direct certification with SNAP. The Reauthorization Act included a parallel conforming amendment in section 11(u) of the Food and Nutrition Act of 2008 (formerly the Food Stamp Act) 7 U.S.C. 2020(u).

As specified in the NSLA, the agreements were to be in place by July 1, 2005. In a memorandum dated April 19, 2005 (SP 14, Agreement Checklist for Direct Certification and Direct Verification of Children in Food Stamp Households; http://www.fns.usda.gov/cnd/governance/Reauthorization_Policy_04/Reauthorization_04/2005-04-19.pdf ), the Department provided guidance on initial items that the State agencies responsible for administering the school meals programs and the State agencies administering SNAP should include in the agreement. All State administering agencies, including those responsible for non-public schools or residential child care institutions, must have an agreement with the State agency administering SNAP. In order to fully support effective direct certification efforts, this interim rule requires that the agreement address how direct certification will be conducted, including frequency; what notification method(s) will be used; how use of the letter method will be phased-out as the primary method and what system will replace it; how the system and procedures will identify additional children in the household who are categorically eligible based on one household members' receipt of benefits; and other specifics needed to ensure efficient operation of direct certification.

The methods used to conduct direct certification can always be improved and expanded and should not be considered static. The more children who are identified as eligible through direct certification assists both families and local educational agencies by simplifying the certification process and by more accurately targeting free meal benefits.

As a result of this interim rule, the State agencies administering the school meals programs may need to amend their existing agreements with the State agencies responsible for SNAP to set up procedures to conduct more frequent direct certification. Because the addenda to the agreement would depend on the system used, State agencies must determine what amendments are needed. The requirement for the agreement is found at paragraph 245.6(b)(1)(iv) of this interim rule.

The Reauthorization Act also extended categorical eligibility and direct certification to additional programs for homeless, migrant and runaway children. 5 In most cases, we expect that these children will be certified through direct contact with official sources as discussed below. However, it is also possible that the families of some of these children might identify themselves through the free/reduced price application as categorically eligible. Paragraph 245.6(b)(5) of this interim rule specifies what documentation is needed to substantiate certification with appropriate officials. Officials responsible for free meal or free milk eligibility determinations are not responsible for making the determination that a child is homeless, migrant or a runaway. Rather, they are to coordinate with and accept the documentation from a person or agency authorized to make those determinations.

Section 107 of the Reauthorization Act amended the NSLA to extend categorical eligibility for free school meals to children who are homeless, as defined under section 725(2) of the McKinney-Vento Homeless Assistance Act 42 U.S.C. 11434a(2). The McKinney-Vento Homeless Assistance Act defines as homeless individuals those lacking a fixed, regular and adequate nighttime residence.

In accordance with requirements of the McKinney-Vento Homeless Assistance Act, each local educational agency must designate a local educational liaison for homeless children and youth. The local liaison serves as one of the primary contacts between homeless families and school staff and district personnel, shelter workers and other service providers. The shelter director or local educational liaison for homeless children and youth provides the necessary documentation for direct certification to be used by local educational agencies. A memorandum dated July 19, 2004, “SP 4 Categorical Eligibility for Free Lunches and Breakfasts of Runaway, Homeless and Migrant Youth ( http://www.fns.usda.gov/cnd/Governance/policy.htm ) advised State agencies of categorical free meal or free milk eligibility provisions relating to homeless children and youth mandated by the Reauthorization Act.

School officials must accept documentation which meets regulatory requirements and confirms that identified children are homeless from the local educational agency's liaison for homeless children. School officials also must accept a letter or other document from the director of the homeless shelter where the child resides. This provision is found at paragraph 245.6(b)(6)(ii). In addition, this interim rule provides at paragraph 245.6(b)(5) that documentation to substantiate free meal or milk eligibility includes the child's name or a list of names, a statement that certifying that the children are eligible for that program and the signature of the local educational liaison or the director of the homeless shelter and the date of the signature. This rule provides that documentation is acceptable in lieu of a free and reduced price meal or free milk application. We continue to encourage local educational agencies to identify and work with the local educational agency liaison for homeless children and with directors of homeless shelters where children may reside to expedite benefits to homeless children.

Section 107 of the Reauthorization Act made children served by a runaway and homeless youth grant program established under the Runaway and Homeless Youth Act (42 U.S.C. 5701 et seq. ) categorically eligible for free school meals. A child who is a runaway must be participating in a runaway and homeless youth grant program under the Runaway and Homeless Youth Act to be categorically eligible for free meal benefits and for direct certification. The Family and Youth Services Bureau (FYSB), part of the Administration on Children and Families of the United States Department of Health and Human Services, awards funding to local community agencies to offer services to young people and their families. There are three grant programs for runaways under that title—Basic Center Program, Transitional Living Program and the Street Outreach Program. The agencies receiving grants under these three programs are referred to as either FYSB grantees, or Runaway and Homeless Youth (RHY) service providers.

Additionally, the 2003 Reauthorization of the RHY Program directed FYSB to coordinate with local educational agency liaisons under the McKinney-Vento Homeless Assistance Act to assure that RHY are provided information about the educational services available to them and to ensure they receive support services guaranteed under the law. Therefore, the first source for documentation for these children is the local educational agency's homeless liaison.

This interim rule provides in paragraph 245.6(b)(5)(iii) that documentation to substantiate free meal or milk eligibility must consist, at a minimum, of the youth's name, or a list of names, a statement certifying that the children are eligible for that program, the signature of the McKinney-Vento local educational agency's liaison or the RHY service provider(s) and the date signed. Documentation which meets the regulatory requirements must be accepted in lieu of a free meal or milk application. It is important that schools/local educational agencies become familiar with their local RHY service providers and their McKinney-Vento local educational agency's liaison in order to facilitate the service of free school meals or milk for youth in the programs administered by the FYSB.

The Reauthorization Act extended categorical eligibility to migratory children as defined in section 1309 of the Elementary and Secondary Education Act of 1965 (ESEA). In general, a migrant child is one who has moved across local educational agency boundaries, within the last three years, to accompany or join a parent or guardian who has moved to seek or obtain temporary or seasonal work in agriculture or fishing. Please note, however, that it is not necessary for local educational agency personnel to apply the ESEA definition because there are State educational agency and local MEP staff who are responsible for identifying (and maintaining supporting documentation) for each eligible migrant child under ESEA.

As recognized in paragraph 245.6(b)(6)(ii) of this interim rule, local educational agencies will benefit from working directly with MEP coordinators or, where appropriate, the State MEP director, to identify migrant children and to document their eligibility for free school meals. Pursuant to paragraph 245.6(b)(5)(iii), local educational agencies must accept documentation that the children are migrant children from the MEP coordinator. Such documentation of migrant status to substantiate free meal eligibility may be a list that includes each child's name, a statement certifying that the children are eligible for that program, and the signature of the MEP coordinator or the State MEP director and the date of the signature. This list serves as documentation of categorical eligibility for or migrant children.

It is important that newly enrolled homeless, runaway and migrant children in the local educational agency be identified and certified for free meals or milk as promptly as possible. The Eligibility Guidance for School Meals Manual ( http://www.fns.usda.gov/cnd/Guidance/default.htm ) indicates that, to the extent possible, applications should be processed immediately. This includes determination of eligibility through sources such as the homeless liaison. Local educational agencies need to establish procedures with the coordinators/liaisons to assure they are notified when the coordinators/liaisons identify a new homeless, runaway or migrant child so these children may be promptly certified at any time during the school year. Children also may be determined eligible through the standard application process. If the child is not indentified through coordinators/liaisons and an application is not submitted, paragraph 245.6(d) of the existing regulations allows school officials to complete an application on the child's behalf noting the child is homeless, etc. and giving the source for his/her knowledge. This must be done only on a case-by-case basis.

This interim rule also adds as categorically eligible children who are enrolled as participants in Head Start programs authorized under the Head Start Act. Until enactment of the Improving Head Start for School Readiness Act of 2007 (Pub. L. 110-134), only children enrolled in Head Start who met that program's prescribed low-income criteria were categorically eligible for free school meals. However, section 29(c) of Public Law 110-134 amended section (9)(b)(12)(A)(iii) and section 17(c)(5) of the NSLA to extend categorical eligibility for free meals and free milk to all Head Start enrollees. The original policy on limited categorical eligibility was issued in a memorandum dated April 14, 1995 and the most recent policy was issued in a memorandum dated May 16, 2008, “SP-23-2008, CACFP 07-2008, SFSP 06-2008, Automatic Eligibility for Free Meal Benefits Extended to All Children Enrolled in Head Start” ( http://www.fns.usda.gov/cnd/Governance/policy.htm ). We are now incorporating the most recent statutory requirement into the regulations. Therefore, a definition of a Head Start child is added to § 245.2 and a definition of categorically eligible is added which states that children enrolled in Head Start are categorically eligible for free school meals.

Paragraph 245.6(b)(9) of this interim rule addresses the confidentiality of information obtained through the direct certification process and the prevention of overt identification of children eligible for free or reduced-price meals or free milk. This paragraph incorporates the provisions found in paragraph 245.6(b)(1) prior to the effective date of this rule. However, the wording has been revised to improve readability and to clarify that information obtained about the child's participation in SNAP, FDPIR or TANF must be used for direct certification purposes only and information regarding a child's eligibility status in the Child Nutrition Programs may be used or disclosed solely in accordance with the disclosure provisions in section 9(b)(6) of the NSLA.

The existing provision that schools are not required to provide application materials to children who were approved for free meals through the direct certification process was moved in this interim rule from paragraph 245.6(b)(2) to paragraph 245.6(b)(10).

The existing provision concerning the notification of households in writing of children determined eligible for free meals or free milk through the direct certification process was moved from paragraph 245.6(b)(2) to paragraph 245.6(c)(6)(ii). The current provision also requires that households have an opportunity to decline school meals benefits for their children. A written notice to the household is not required if the direct certification documentation is provided to the school by the household, such as a letter indicating receipt of benefits from SNAP. By providing the school with documentation, the household is indicating that they want free meals or milk for their children. Paragraph 245.6(c)(5) is also being revised in this interim rule to include the new categories of children (homeless, Head Start, runaways and migrants) who may be directly certified.

The following outlines changes, made by Public Law 108-265 and Public Law 110-134, which are addressed in § 245.2, Definitions, to reflect statutory amendments and for clarification purposes.

Categorically eligible—This rule adds a new definition, “Categorically eligible,” in § 245.2. “Categorically eligible” means that children are eligible for free meals or free milk, as applicable, based on the child's status as—

• A member of a household receiving assistance under SNAP or FDPIR or a member of a family receiving benefits under the TANF program;

• An enrollee in the Head Start Program;

• A runaway child served by grant programs established under the Runaway and Homeless Youth Act;

• A homeless child as defined under the McKinney-Vento Homeless Assistance Act; or

• A migratory child as specified under the Migrant Education Program.

Documentation—Paragraph (2) of the definition of “Documentation” in § 245.2 defines documentation for direct certification purposes as the name of the child; a statement certifying that the child is receiving assistance from SNAP, FDPIR or TANF program; information in sufficient detail to match the child attending school in the local educational agency; the signature of the appropriate SNAP, FDPIR, or TANF official; and the date. The definition also clarifies that when the signature is impracticable to obtain, such as in computerized operations providing an electronic signature, other arrangements may be accepted if the local educational agency has a method to ensure that a responsible official from the assistance program can attest to the accuracy of the information provided. This interim rule revises the definition of “Documentation” to address acceptable documentation from SNAP, FDPIR or TANF Program; acceptable documentation for children in a family with at least one member receiving benefits from SNAP, FDPIR or TANF; acceptable documentation for Head Start children, homeless and migrant children and runaway children who participate in the respective Federal program.

Head Start child, Homeless child, Migrant child and Runaway child—Definitions for each of these are added consistent with the intent of Section 107 of the Reauthorization Act.

Pursuant to section 12(a) of the NSLA and current regulations, local educational agencies agree to maintain files of currently approved and denied applications and documentation for direct certification as part of their agreement to administer the program at the school district level. Paragraph 210.9(b) is being revised by this rule to include the new categories of children who may be directly certified (i.e., homeless, certain runaway and migrant children and Head Start enrollees). The review requirements in paragraph 210.18(g) are also amended to add the new categories of children who may be directly certified. Paragraph 210.18(g)(1)(B) is also being amended to conform with changes made in the November 13, 2007, interim regulation (72 FR 63785) that established year-long eligibility for free and reduced price meals.

We are also using this opportunity to clarify the relationship between delayed implementation of Provision 2 as permitted in paragraph 245.9(b)(6)(ii) and use of a child's prior year's eligibility status for the first 30 operating days in the new school year (“carryover”) in paragraph 245.6(c)(2). Delayed implementation permits schools establishing claiming percentages for Provision 2 to charge participating students for meals in the first claiming period of the base year. This exception is permitted to assist schools in securing completed free and reduced price applications from households which might not otherwise submit an application if there is no charge for meals. With the State agency's approval, schools may delay implementing Provision 2 for a period not to exceed the first claiming period of the base year. When the carryover provision was added in the interim rulemaking dated November 13, 2007, (72 FR 63793), we did not address how it applied to delayed implementation. Therefore, we are revising paragraph 245.6(c)(2) to indicate that carryover is not required when schools are approved to use the delayed implementation in relation to Provision 2.

We are also making technical amendments to paragraph 210.18(g)(1)(i)(A)(3) to reflect the recent changes to the carryover provision that no longer permit the State agency to establish a different timeframe. Other technical changes are to correct an omission in the introductory text of paragraph 210.19(c) by adding a reference to paragraph 210.19(c)(iii), which was inadvertently left out, and to correct a citation in the definition of “School in severe need” in § 220.2 that should refer to paragraph 220.9(d), not paragraph 220.9(e).

We are also using this interim rule to correct a number of obsolete names, addresses, terms of usage, and spelling errors that may appear in parts 210, 215, 220, 225, 226, and 245.

As mandated by the Food, Conservation and Energy Act of 2008, effective October 1, 2008, the Food Stamp Program was renamed as the Supplemental Nutrition Assistance Program or SNAP. This interim rule amends parts 210, 215, 225, 226, and 245 to reflect this change.

The new name of the General Accounting Office, the Government Accountability Office (GAO), is made to paragraphs 225.6(h)(vii) and 226.10(d). This interim rule also replaces the term “handicap” with the term “disability” in paragraphs 225.8(g)(i), 225.15(e), 226.23(c)(5), 226.23(e)(2)(iv), and 226.23(h). Other corrections are a reference to CACFP in paragraph 226.23(e)(1)(iii)(E) and the spelling of “labeled” in paragraph 225.15(e).

Paragraph 245.3(b) is also revised to improve the readability of regulations and to delete a procedure applicable only to single child applications, which may no longer be used by local educational agencies.

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

This interim rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.

The 2004 Reauthorization Act requires local educational agencies to establish systems to directly certify SNAP participant children for free school meals no later than School Year 2008-2009. The Reauthorization Act also extends categorical eligibility and provides for the direct certification of certain homeless, migrant, or runaway children. This interim rule makes necessary changes to implement these statutory requirements.

The rule is expected to enhance access to the school meals and milk programs by needy children, decrease duplicative paperwork for households, decrease the administrative costs of processing and reviewing applications, and improve program integrity. Mandatory direct certification based on SNAP participation increased certifications for free school meals by an estimated 190,000 children in School Year 2008-2009. The interim rule's requirement that local educational agencies conduct direct certification at least three times per year beginning in School Year 2011-2012 may increase the number of children certified for free meals (for at least part of the school year) by an additional 270,000.

Direct certification increases the number of children certified to receive free school meals, which raises the cost of federal meal reimbursements to participating schools. State and local education, SNAP, and child welfare agencies also incur administrative costs associated with direct certification. Total meal reimbursement and administrative costs are estimated to have increased by more than $114 million over the five fiscal years from 2005 through 2009. (State SNAP and Child Nutrition Agencies begin to incur administrative costs in fiscal year 2005, the year prior to the mandatory implementation of direct certification by large LEAs under the terms of the 2004 Reauthorization Act.) The estimated ten-year cost of the rule, through FY 2014, is nearly $760 million. More than $730 million of this amount is the cost of Federal reimbursement to schools for free meals served to newly certified children.

This interim rule has been reviewed with regard to the requirements of the Regulatory Flexibility Act. It is certified that this interim rule will not have a significant economic impact on a substantial number of small entities. Determining children eligible for free meals or free milk by obtaining eligibility information directly from another agency will reduce duplicative paperwork for households who have already established their need for assistance to certain programs which serve low-income children and adults, and will streamline the free and reduced price application and certification process for schools. The provisions of this rule will enhance access to these programs by needy children. Although there may be some initial burdens associated with implementation of this rule, the burdens will not be significant and will be outweighed by the long-term benefits of direct certification and expanded categorical eligibility.

Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes a requirement for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, the Department generally must prepare a written statement, including a cost-benefit analysis. This is done for proposed and final rules that have Federal mandates which may result in expenditures of $100 million or more in any one year by State, local, or tribal governments, in the aggregate, or by the private sector. When this statement is needed for a rule, section 205 of the UMRA generally requires the Department to identify and consider a reasonable number of regulatory alternatives. It must then adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule.

This rule contains no Federal mandates of $100 million or more in any one year (under regulatory provisions of Title II of the UMRA) for State, local, and tribal governments or the private sector. Thus, this interim rule is not subject to the requirements of sections 202 and 205 of the UMRA.

The National School Lunch Program, Special Milk Program, School Breakfast Program Summer Food Service Program, and Child and Adult Care Food Program are listed in the Catalog of Federal Domestic Assistance under Nos. 10.555, 10.556, 10.553, 10.559 and 10.558, respectively. For the reasons set forth in the final rule in 7 CFR part 3015, subpart V, and final rule related notice at 48 FR 29114, June 24, 1983, these programs are included in the scope of Executive Order 12372, which requires intergovernmental consultation with State and local officials.

Executive Order 13132 requires Federal agencies to consider the impact of their regulatory actions on State and local governments. Where such actions have federalism implications, agencies are directed to provide a statement for inclusion in the preamble to the regulation describing the agency's considerations in terms of the three categories called for under section (6)(b)(2)(B) of Executive Order 13132.

Prior to drafting this rule, we received input from State and local agencies at various times. The Child Nutrition Programs (CNP) are State administered, federally funded programs. Staff from FNS' headquarters and regional offices had informal and formal discussions with State and local officials on an ongoing basis regarding program implementation and performance. This arrangement allows State and local agencies to provide feedback that helps form the basis for any discretionary decisions in this and other CNP rules. Additionally, we convened a meeting of representative Federal and State administrators of SNAP and CNP State directors to discuss their current direct certification procedures. Department officials have also provided overviews of the changes made in the certification process at meetings attended by local educational agency representatives, advocacy groups and other interested parties. These sessions provided FNS officials with insights into areas of concerns from these groups and allowed us to obtain background into how local and State administrators are currently doing certification and direct certification and how the statutory changes will affect these procedures.

State and local agencies are generally concerned about improving the integrity of the free and reduced price meal eligibility process without hindering access to the programs. They also are concerned about the paperwork and financial burdens placed on food service to determine free and reduced price meal eligibility and the initial cost of implementing direct certification.

The issuance of this regulation is required by amendments made to the Richard B. Russell National School Lunch Act by the Reauthorization Act. Prior to those amendments, program officials were permitted to directly certify children in households receiving benefits from SNAP, TANF and FDPIR. This rule now requires local educational agencies to directly certify children in households receiving benefits from SNAP and permits the direct certification of children in households receiving TANF or FDPIR benefits, as well as homeless, some runaway children and migrant children.

By extending categorical eligibility to all children in a family based on one (or more) children's receipt of SNAP, FDPIR or TANF benefits, access to free meals is improved and the application process streamlined for both families and local educational agencies. Integrity is also addressed in this provision because the large majority of these other children are otherwise income eligible for free meals or are actually receiving assistance from these programs but were not readily identified. Additionally, children whose eligibility is determined through the direct certification process are exempt from the verification of eligibility process which reduces the burden placed on households. The inclusion of all children in the family as categorically eligible if other children are identified through direct certification eliminates the need for an application and further reduces the number of applications subject to verification. Local educational agencies can reduce the number of applications/households that are subject to verification by using direct certification as much as possible. These amendments will reduce paperwork and financial burdens placed on local educational agencies.

This rule is intended to have a preemptive effect on any State law that conflicts with its provisions or that would otherwise impede its full implementation. To the extent the rule includes discretionary changes, the Department has established compliance timeframes which give due consideration to State agency processes for notification of customers and stakeholders for the implementation of the new procedures in local offices.

This interim rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is intended to have preemptive effect with respect to any State or local laws, regulations or policies which conflict with its provisions or which would impede its full implementation. This rule is not intended to have retroactive effect unless that is specified in the Effective Date section of the preamble of the rule. Before any judicial challenge to the provisions of this rule or the application of its provisions, all administrative procedures that apply must be followed. The only administrative appeal procedures relevant to this interim rule are the hearings that local educational agencies must provide for decisions relating to eligibility for free and reduced price meals and free milk (§ 245.7 for the NSLP, SBP, and SMP in schools).

FNS has reviewed this interim rule in accordance with the Department Regulations 4300-4, “Civil Rights Impact Analysis,” to identify any major civil rights impacts the rule might have on children on the basis of race, color, national origin, sex, age or disability. After a careful review of the rule's intent and provisions, FNS has determined that this interim rule facilitates the participation of all eligible participants and does not establish any new burdens.

USDA will undertake, within six months after this rule becomes effective, a series of Tribal consultation sessions to gain input from elected Tribal officials or their designees concerning the impact of this rule on Tribal governments, communities and individuals. These sessions will establish a baseline of consultation for future actions, should any be necessary, regarding this rule. Reports from these sessions for consultation will be made part of the USDA annual reporting on Tribal Consultation and Collaboration. USDA will respond in a timely and meaningful manner to all Tribal government requests for consultation concerning this rule and will provide additional venues, such as webinars and teleconferences, to periodically host collaborative conversations with Tribal leaders and their representatives concerning ways to improve this rule in Indian country.

The policies contained in this rule would not have Tribal implications that preempt Tribal law.

The Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35; see 5 CFR 1320), requires that the Office of Management and Budget (OMB) approve all collections of information by a Federal agency from the public before they can be implemented. Respondents are not required to respond to any collection of information unless it displays a current, valid OMB control number. This is a new collection. The new provisions in this rule, which do increase burden hours, affect the information collection requirements that will be merged into the National School Lunch Program, OMB Control Number #0584-0006, expiration date March 31, 2012, and the Determining Eligibility for Free and Reduced Price Meals, OMB Control #0584-0026, expiration date March 31, 2013. The current collection burden inventory for the National School Lunch Program (7 CFR 210) is 11,846,904; and the current collection burden inventory for Determining Eligibility for Free and Reduced Price Meals (7 CFR part 245) is 1,073,432. These changes are contingent upon OMB approval under the Paperwork Reduction Act of 1995. When the information collection requirements have been approved, FNS will publish a separate action in the Federal Register announcing OMB's approval.

Comments on the information collection in this interim rule must be received by June 24, 2011. Send comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for FNS, Washington, DC 20503. Please also send a copy of your comments to Lynn Rodgers-Kuperman, Chief, Program Analysis and Monitoring Branch, Child Nutrition Division, 3101 Park Center Drive, Alexandria, VA 22302. For further information, or for copies of the information collection requirements, please contact Lynn Rodgers-Kuperman at the address indicated above. Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the Agency's functions, including whether the information will have practical utility; (2) the accuracy of the Agency's estimate of the proposed information collection burden, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All responses to this request for comments will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

Title: Direct Certification and Certification of Homeless, Migrant and Runaway Children for Free School Meals.

OMB Number: 0584-NEW.

Expiration Date: Not Yet Determined.

Type of Request: New Collection.

Abstract: Under the mandatory direct certification process, the local educational agency (note: this term replaces the term school food authority for the purposes of determining eligibility for free or reduced price school meals) must directly certify, as eligible for free school meals, children who are members of a household that is receiving benefits from the Supplemental Nutrition Assistance Program (SNAP). In addition, they will continue to have the option of directly certifying children who are members of households receiving assistance under the Food Distribution Program on Indian Reservations (FDPIR), or Temporary Assistance for Needy Families (TANF) program. The local educational agency obtains documentation from the State or local agency administering SNAP, FDPIR or TANF. The documentation establishes children's automatic eligibility for free meals because of receipt of benefits from the SNAP, FDPIR or TANF. Direct certification is done in lieu of a family filing a free and reduced price application.

This interim rule also establishes categorical eligibility for free meals for children in other programs. These are—children enrolled in a Head Start program; children identified as homeless under the McKinney-Vento Homeless Assistance Act (42 U.S.C. 11434a (2)); children identified as migratory under section 1309 of the Elementary and Secondary Education Act of 1965 (20 U.S.C. 6399); and children identified as runaways receiving assistance under a program under the Runaway and Homeless Youth Act (42 U.S.C. 5701 et seq. ). These children are identified by officials responsible for administering these programs or by school officials responsible for identifying these children who are enrolled in their school districts. For example, each school district must have a local liaison who identifies homeless, runaway or migratory children. In addition, Head Start officials or representatives of the local Migrant Education Program may provide the names of eligible children.

For mandatory direct certification with SNAP, optional direct certification with FDPIR or TANF and eligibility determinations made for children who are categorically eligible based on Head Start participation and the other programs discussed above, the paperwork burden for the local educational agency is due to the requirement to obtain documentation and retain it for review purposes.

This interim rule will increase the recordkeeping burden on the current collection burden inventory for the National School Lunch Program, OMB Control Number #0584-0006, because local educational agencies will be required to retain additional records containing the names of children directly certified for National School Lunch Program. This interim rule will increase the recordkeeping burden and decrease the reporting burden on the current collection burden inventory for Determining Eligibility for Free and Reduced Price Meals, OMB Control #0584-0026, because State agencies must maintain additional agreements and fewer households will be required to complete an application form. The interim rule will not change the recordkeeping nor the reporting burden on the current collection burden inventory for School Breakfast Program, OMB Control #0584-0012, as those respondents participating in the School Breakfast Program also participate in the National School Lunch Program; thus the burden associated with the School Breakfast Program will be carried in the National School Lunch Program. The average burden per response and the annual burden hours are explained below and summarized in the charts which follow.

Respondents for this Interim Rule: Local Educational Agencies.

Estimated Number of Respondents for this Interim Rule: 20,948.

Estimated Number of Responses per Respondent for this Interim Rule: 4.

Estimated Total Annual Responses: 83,792.

Estimated Total Annual Burden on Respondents for this Interim Rule: 52,370.

Background

On March 31, 2008 (73 FR 17176), the NRC published a final rule in the Federal Register amending Title 10 of the Code of Federal Regulations, Part 26, “Fitness for Duty Programs.” The Commission updated the requirements in 10 CFR part 26 by reorganizing the rule and adding Subpart I, “Managing Fatigue.” Subpart I establishes requirements for managing worker fatigue at operating nuclear power plants, which was in response to a need for clear and enforceable requirements for the management of worker fatigue. Although the rule was effective on April 30, 2008, the NRC permitted an 18-month implementation period for Subpart I.

On September 3, 2010, the Nuclear Energy Institute (NEI) submitted a petition for rulemaking (PRM-26-5) (ML102590440). The NEI stated that “the new rule has resulted in consequences not originally envisioned when the rule was developed and that these consequences have diminished the safety benefits of the rule.” The NEI has stated that the unintended consequences stem from the minimum days off requirements, specifically § 26.205(d)(3) through § 26.205(d)(6), which create an undue level of complexity and inflexibility in managing worker fatigue. The NEI requested, among other changes, that 10 CFR part 26, Subpart I, be amended to replace the MDO requirements in § 26.205(d) with a performance-based objective, consisting of an average of 54 hours worked per week, averaged over a calendar quarter rather than over each shift cycle. The NEI also proposed changing the annual assessment in § 26.205(e)(1) to a quarterly assessment to provide a more frequent review of hours worked. The NEI proposed to eliminate the MDO requirements addressed at § 26.205(d)(3) through § 26.205(d)(6), while the work hour limits and break requirements (§ 26.205(d)(1)(i), § 26.205(d)(1)(ii), § 26.205(d)(1)(iii), § 26.205(d)(2)(i), and § 26.205(d)(2)(ii)), would remain unchanged and apply during on-line and outage periods.

Separate from PRM-26-5, on September 23, 2010, the NEI submitted a request for enforcement discretion regarding the MDO provisions of 10 CFR part 26 (ML102710208). The request reiterates the NEI's opinion that the regulations that govern fatigue management impede “many safety-beneficial practices at plant sites, adversely [impact] the quality of life of covered workers, and [result] in conflicts between rule requirements and represented bargaining unit agreements.” The letter requests that the NRC “exercise enforcement discretion from the [MDO] provisions of the rule” until the final disposition of PRM-26-5.

The NRC held three public meetings (November 18, 2010, January 6, 2011, and January 25, 2011), during which the staff and stakeholders discussed alternatives to the MDO requirements. Although some of the stakeholders were comfortable with the MDO requirements, most focused their discussion on the unintended consequences, which they claim have diminished the safety benefits of the rule, along with the need for an alternative that is simpler and would provide greater scheduling flexibility. The staff's goal was to develop an alternative approach that was responsive to the needs of stakeholders, would maintain clear and enforceable requirements, and would ensure that the effects of cumulative fatigue are appropriately managed by licensees.

Cumulative fatigue is caused by consecutive days of restricted or poor quality sleep caused by such things as shift-work, extended work days, and extended work weeks. Currently, Subpart I requires licensees to manage cumulative fatigue primarily by providing workers with a minimum number of days off over the course of a period not to exceed 6 weeks. The distribution of the days off during the 6-week period act to either prevent or mitigate fatigue. An alternative method for managing cumulative fatigue is to establish a requirement to limit actual hours worked. A limit on actual hours worked, when applied to schedules that require regular shift coverage, limits the number of work hours that can contribute to cumulative fatigue and provides indirect assurance of periodic days off for recovery rest. A schedule resulting in a weekly average of 54 hours worked, calculated using a rolling window of up to 6 weeks, is such a schedule. In general, most individuals that work their normal shift duration and receive only the minimum number of days off required under the current MDO requirements could average up to 54 hours per week. However, the NEI has indicated that implementation of the MDO requirements has reduced licensee scheduling flexibility and imposed a substantial administrative burden. By comparison, limiting work hours to an average of not more than 54 hours per week by using a rolling window of up to 6 weeks limits the number of consecutive weeks of extended work hours that an individual can work by using a comparable but simpler and more flexible requirement. In addition, this alternative eliminates the burden of tracking the number of days off that an individual receives in each shift cycle.

In summary, the maximum hours that can be worked under the alternative approach is comparable to the maximum hours worked under the current 10 CFR part 26 MDO requirements, except that the alternative approach provides for greater simplicity and flexibility. This alternative is only applicable to § 26.205(d)(3) and covered workers described in § 26.4(a). Neither the NEI's PRM-26-5 nor its enforcement discretion request offered any comparably effective alternatives for § 26.205(d)(4), § 26.205(d)(5), and § 26.205(d)(6), nor were any identified during the public meetings; therefore, the staff is taking no action in regard to those regulations.

The staff determined that replacing the current MDO requirements and requiring all licensees to adopt this interim alternative approach has the potential for introducing adverse consequences if those licensees satisfied with MDO requirements were forced to change. As a result, the interim enforcement policy would allow licensees to choose whether or not to implement this alternative approach. Licensees who properly implement this alternative approach will receive enforcement discretion for failing to meet the requirements of 10 CFR 26.205(d)(3).

Although the rolling schedule required under the alternative approach limits the number of consecutive extended work weeks and thereby limits the potential for cumulative fatigue, there are unusual potential circumstances where the average can be met and the schedule may be fatiguing; however, the industry has stated that these unusual schedules are improbable. Such schedules include having only one in every nine days off or consistently working the maximum allowable hours, which would likely result in cumulative fatigue. Nevertheless, the staff believes that this alternative approach, together with other aspects of the rule that will remain unchanged, will provide reasonable assurance that licensees manage cumulative fatigue consistent with the protection of public health, safety, and security. The staff will engage licensees during regularly scheduled public meetings in the coming months to identify problems and lessons learned from implementation of the alternative approach.

Licensees must inform the NRC of their intent to adopt the alternative approach, and must comply with all requirements of Subpart I, as applicable. The interim policy will remain in place until the NRC publishes a new final rule associated with the MDO requirements in 10 CFR part 26, subpart I.

The NRC is not requesting public comment on this alternative approach at this time; instead, the NRC will seek public comment on the effectiveness of this approach during the comment period for a proposed rule associated with the MDO requirements in 10 CFR part 26, subpart I.

This policy statement does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). Existing requirements were approved by the Office of Management and Budget (OMB), Approval Number 3150-0136.

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.

In accordance with the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.

Accordingly, the NRC Enforcement Policy is revised to read as follows:

CBP preclearance operations have been in existence since 1952. Preclearance facilities are established through the cooperative efforts of CBP, foreign government representatives, and the local facility authorities and are evidenced with signed preclearance agreements. Each facility is staffed with CBP officers responsible for conducting inspections and examinations in connection with preclearing passengers, crew, and their goods bound for the United States. Generally, travelers who are inspected at a preclearance facility are permitted to arrive at a U.S. domestic facility and exit the U.S. domestic terminal upon arrival or connect directly to a U.S. domestic flight without further CBP processing. Preclearance facilities primarily serve to facilitate low risk travelers, relieve passenger congestion at federal inspection facilities in the United States, and enhance security in the air environment through the screening and inspection of travelers prior to their arrival in the United States. In Fiscal Year 2010, over 14 million aircraft travelers were processed at preclearance locations. This figure represents more than 16 percent of all commercial aircraft travelers cleared by CBP in FY 2010.

The Agreement Between the Government of the United States of America and the Government of Ireland on Air Transport Preclearance was signed on November 17, 2008. Preclearance operations began in Dublin, Ireland on January 19, 2011. The Dublin preclearance station is open for use by commercial flights.

Section 101.5 of the CBP regulations (19 CFR 101.5) sets forth a list of CBP preclearance offices in foreign countries. This document amends this section to add Dublin, Ireland to the list of preclearance offices.

This amendment reflects the addition of a new CBP preclearance office that was established through a signed agreement between the United States and the Government of Ireland. Accordingly, pursuant to 5 U.S.C. 553(b)(B), notice and public procedure are unnecessary. For the same reason, pursuant to 5 U.S.C. 553(d)(3), a delayed effective date is not required.

Because no notice of proposed rulemaking is required, the provisions of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) do not apply. This amendment does not meet the criteria for a “significant regulatory action” as specified in Executive Order 12866.

This document is being issued in accordance with 19 CFR 0.2(a).

For the reasons set forth above, Part 101 of the Code of Federal Regulations (19 CFR part 101), is amended as set forth below.

The FD&C Act (21 U.S.C. 301 et seq. ), as amended by the 1976 Amendments (Pub. L. 94-295), the SMDA (Pub. L. 101-629), and the FDAMA (Pub. L. 105-115), established a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established three categories (classes) of devices, depending on the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Under section 513 of the FD&C Act, devices that were in commercial distribution before May 28, 1976 (the date of enactment of the 1976 Amendments), generally referred to as preamendments devices, are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.

Devices that were not in commercial distribution prior to May 28, 1976, generally referred to as postamendments devices, are classified automatically by statute (section 513(f) of the FD&C Act (21 U.S.C. 360c(f)) into class III without any FDA rulemaking process. Postamendment devices remain in class III and require premarket approval, unless the device is reclassified into class I or II, or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act (21 U.S.C. 360c(i)), to a predicate device that does not require premarket approval. The agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).

A preamendments device that has been classified into class III may be marketed, by means of premarket notification procedures, without submission of a premarket approval application (PMA) until FDA issues a final regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval.

Section 513(e) of the FD&C Act (21 U.S.C. 360c(e)) governs reclassification of classified preamendments devices. This section provides that FDA may, by rulemaking, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify a preamendments device. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. ( See, e.g., Holland Rantos v. United States Department of Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (DC Cir. 1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966)).

Reevaluation of the data previously before the agency is an appropriate basis for subsequent regulatory action where the reevaluation is made in light of newly available regulatory authority (see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v . FDA, 762 F. Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in “medical science.” (See Upjohn v. Finch, supra, 422 F.2d at 951). Regardless of whether data before the agency are past or new data, the “new information” to support reclassification under section 513(e)(1) of the FD&C Act must be “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act (21 U.S.C. 360c(a)(3)) and 21 CFR 860.7(c)(2). ( See, e.g., General Medical Co. v . FDA, 770 F.2d 214 (DC Cir. 1985); Contact Lens Assoc. v. FDA, 766 F.2d 592 (DC Cir.), cert. denied, 474 U.S. 1062 (1985)). FDA relies upon “valid scientific evidence” in the classification process to determine the level of regulation for devices. For the purpose of reclassification, the valid scientific evidence upon which the agency relies must be publicly available. Publicly available information excludes trade secret and/or confidential commercial information, e.g., the contents of a pending PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).

In accordance with section 513(e) of the FD&C Act and 21 CFR 860.130(b)(1), based on new information with respect to the device, FDA, on its own initiative, is reclassifying this device from class III to class II.

As discussed in the proposed rule, the agency issued a final rule classifying this device into class III (53 FR 23856, June 24, 1988). In August 1997, in response to FDA's order for the submission of information on the TOCE, two manufacturers submitted 515(i) summaries of safety and effectiveness information to the agency for the TOCE. FDA referred the 515(i) submissions to the General and Plastic Surgery Devices Panel (GPS Panel) for their recommendation on the requested reclassification. At a public meeting on November 17, 1998, the GPS Panel recommended that the device be retained in class III.

Since the 1998 GPS Panel meeting, three studies (two prospective and one retrospective) reported safe use and adequate healing of wounds using the TOCE. In addition, FDA has evaluated more than 20 years of clinical experience with the device and the agency's Medical Device Reports, and has found sufficient information to determine the risks to health associated with the use of this device and develop appropriate special controls.

As a result, in the Federal Register of April 6, 2006 (71 FR 17390), FDA proposed to reclassify the TOCE device from class III to class II. The device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores. Elsewhere in the Federal Register of April 6, 2006 (71 FR 17476), FDA announced the availability of the draft guidance document entitled “Class II Special Controls Draft Guidance Document: Topical Oxygen Chamber for Extremities,” which FDA intended to serve as the special control for this device type following the effective date of the final reclassification rule.

Interested persons were invited to comment until July 5, 2006, on the proposed regulation and special controls draft guidance document.

FDA received 11 comments on the proposed rule. The comments received discussed academic literature, clinical experiences, and patient outcomes that support the proposed reclassification's determinations of the safety and effectiveness of the TOCE device. The comments did not recommend any changes to the proposed regulation.

Based on the information discussed in the preamble to the proposed rule, the comments on the proposed rule, a review of the Manufacturer and User Facility Device Experience (MAUDE) database, and a review of current scientific literature, FDA concludes that special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness of TOCE. The agency is, therefore, reclassifying TOCE from class III (premarket approval) into class II (special controls) and issuing a final rule that revises 21 CFR 878.5650. Elsewhere in this issue of the Federal Register , FDA is announcing the availability of the guidance document entitled “Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,” which will serve as the special control for this device. Following the effective date of this final classification rule, any firm submitting a 510(k) premarket notification for a TOCE will need to address the issues covered in the special controls guidance. However, the firm need only show that its device meets the recommendations of the guidance or in some other way provides equivalent assurances of safety and effectiveness.

Section 510(m) of the FD&C Act (21 U.S.C. 360(m)) provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of the safety and effectiveness of the TOCE and, therefore, this device type is not exempt from premarket notification requirements.

The agency has determined under 21 CFR 25.34(b) that this reclassification action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this final rule is not a significant regulatory action under the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the final rule reclassifying this device from class III to class II will relieve all manufacturers of the device of the cost of complying with the premarket approval requirements of section 515 of the FD&C Act, it will impose no significant economic impact on any small entities, and it may permit small potential competitors to enter the marketplace by lowering their costs, and the agency certifies that the final rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $135 million, using the most current (2009) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this final rule to result in any 1-year expenditure that would meet or exceed this amount.

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State law conflicts with the exercise of Federal authority under the Federal statute.” Federal law includes an express preemption provision that preempts certain State requirements “different from or in addition to” certain Federal requirements applicable to devices. (See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic Inc., v. Lohr, 518 U.S. 470 (1996); Riegel v. Medtronic Inc., 128 S. Ct. 999 (2008)). The special controls established by this final rule create “requirements” for specific medical devices under 21 U.S.C. 360k, even though product sponsors have some flexibility in how they meet those requirements. See Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997).

This final rule contains no collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520) is not required. FDA concludes that the special controls guidance document identified by this rule contains information collection provisions that are subject to review and clearance by OMB under the PRA.

Elsewhere in this issue of the Federal Register , FDA is publishing a notice announcing the availability of the guidance document entitled, “Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities.” The notice contains an analysis of the paperwork burden for the guidance.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 878 is amended as follows:

DoD has determined this rulemaking meets the criteria for a direct final rule because it involves nonsubstantive changes dealing with DoD's management of its Privacy Progams. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register . A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.

It has been determined that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

It has been determined that Privacy Act rules for the Department of Defense impose no additional information collection requirements on the public under the Paperwork Reduction Act of 1995.

It has been determined that Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

It has been determined that Privacy Act rules for the Department of Defense do not have federalism implications. The rules do 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.

Accordingly, 32 CFR 321 is amended as follows:

Direct Final Rule and Significant Adverse Comments

DoD has determined this rulemaking meets the criteria for a direct final rule because it involves nonsubstantive changes dealing with DoD's management of its Privacy Progams. DoD expects no opposition to the changes and no significant adverse comments. However, if DoD receives a significant adverse comment, the Department will withdraw this direct final rule by publishing a notice in the Federal Register. A significant adverse comment is one that explains: (1) Why the direct final rule is inappropriate, including challenges to the rule's underlying premise or approach; or (2) why the direct final rule will be ineffective or unacceptable without a change. In determining whether a comment necessitates withdrawal of this direct final rule, DoD will consider whether it warrants a substantive response in a notice and comment process.

It has been determined that Privacy Act rules for the Department of Defense are not significant rules. The rules do not (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a sector of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in these Executive orders.

It has been determined that Privacy Act rules for the Department of Defense do not have significant economic impact on a substantial number of small entities because they are concerned only with the administration of Privacy Act systems of records within the Department of Defense.

It has been determined that Privacy Act rules for the Department of Defense impose no additional information collection requirements on the public under the Paperwork Reduction Act of 1995.

It has been determined that Privacy Act rulemaking for the Department of Defense does not involve a Federal mandate that may result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100 million or more and that such rulemaking will not significantly or uniquely affect small governments.

It has been determined that Privacy Act rules for the Department of Defense do not have federalism implications. The rules do 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.

Accordingly, 32 CFR part 323 is amended as follows:

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

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 . Any delay in the effective date of this rule would expose the public to the dangers posed when conducting a live practical exercise with a multi-agency underway response by United States Coast Guard, regional law enforcement, including SWAT and special tactics units, and fire department marine units.

The California Maritime Academy has requested that the Coast Guard enforce a temporary safety zone for operations during the Bay Ferry II Maritime Security Exercise from 5:50 a.m. until 12:10 p.m. on April 28, 2011. The Bay Ferry II Maritime Security Exercise is a multi-agency exercise that tests the proficiency of teams called upon in real life emergency situations onboard ferries or other vessels in the San Francisco Bay. The temporary safety zone will encompass General Anchorage 5 between the North and South Shipping Channels to the west and Southampton Shoal Channel to the east in San Francisco Bay. The temporary safety zone is needed to protect exercise participants and provide for the safety of the passenger ferry operators, first responders, their crews, and the public during the full scale security exercise from accidents or other causes of a similar nature.

The Coast Guard is establishing a temporary safety zone that will be enforced on April 28, 2011 from 5:50 a.m. until 12:10 p.m. The limits of the safety zone include the navigable waters of General Anchorage 5 between the North and South Shipping Channels to the west and Southampton Shoals Channel to the east in San Francisco Bay. The safety zone will be located at approximately 37°54′ N and 122°26′10″ W; 37°54′ N and 122°25′30″ W; 37°56′30″ N and 122°26′30″ W; and 37°56′30″ N and 122°25′50″ W (NAD 83).

The temporary safety zone is necessary to protect the public from exercise participants and provide for the safety of the United States Coast Guard, passenger ferry operators, first responders, and their crews during the full scale security exercise from accidents or other causes of a similar nature. Persons and vessels will be prohibited from entering into, transiting through, or anchoring within the temporary safety zone unless authorized by the Captain of the Port, or the Captain of the Port's designated representative.

The temporary safety zone will be enforced by Coast Guard patrol craft and San Francisco Harbor Police as authorized by the Captain of the Port. See 33 CFR 6.04-11, Assistance of Other Agencies.

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

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

Although this regulation will restrict access to the area, the effect of this rule will not be significant because: (1) The safety zone will be in effect for a limited period of time; (2) the Coast Guard will give advance notification via maritime advisories so mariners can adjust their plans accordingly, and (3) the size of the zone is at the minimum necessary to provide adequate protection for the United States Coast Guard, passenger ferry operators, first responders, their crews, and the public.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in General Anchorage 5 in the San Francisco Bay between 5:50 a.m. and 12:10 p.m. on April 28, 2011.

The temporary safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons. Vessel traffic can pass safely around the zone. Before the effective period, the Coast Guard will issue local notice to mariners (LNM) and broadcast notice to mariners (BNM) alerts via VHF-FM marine channel 16 before the safety zone is enforced.

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

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

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

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

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

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

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

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

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

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

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

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

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

An environmental analysis checklist and a categorical exclusion determination are available in the docket where indicated under ADDRESSES .

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

Regulatory Information

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because standard notice procedures are impracticable. Immediate action is necessary to ensure the safety of vessels, spectators, participants, and others in the vicinity of the marine event on the dates and times this rule will be in effect.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying the effective date would be impracticable, because immediate action is needed to ensure the public's safety.

Sea World is sponsoring the Sea World Fireworks, which will include a fireworks presentation from a barge in Mission Bay. Fireworks displays are scheduled to occur on various dates between April 2 and December 31, 2011. This temporary safety zone is necessary to provide for the safety of the crew, spectators, participants, and other vessels and users of the waterway.

The Coast Guard is establishing a temporary safety zone in support of Sea World Fireworks. It will be enforced from 8:45 p.m. to 10:15 p.m. on evenings with a fireworks show. Fireworks shows are currently scheduled for the following dates in 2011: April 2, 9, 16 and 23; May 28, 29 and 30; June 4 and 5, 11 and 12; June 16 through August 21; August 26, 27, and 28; September 3, 4, and 5; November 18; and December 9 and 31. If this schedule changes the Coast Guard will announce the changes via Broadcast Notice to Mariners no less than 24 hours before the event. The safety zone will cover a 600 foot radius surrounding the fireworks barge in approximate position 32°46′03″ N, 117°13′11″ W. The safety zone is necessary to provide for the safety of the crew, spectators, participants, and other vessels and users of the waterway. When this temporary safety zone is being enforced, persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

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

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

We expect the economic impact of this proposed rule to be so minimal that a full Regulatory Evaluation is unnecessary. This determination is based on the size and location of the temporary safety zone. Because of the location, commercial vessels will not be hindered by the safety zone. Recreational vessels will not be allowed to transit through the designated safety zone during the specified times, but the zone will only be enforced for approximately ninety minutes a night.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: the owners and operators of vessels wishing to transit through or anchor in the impacted portion of Mission Bay on the nights with Sea World fireworks shows.

This rule will not have a significant economic impact on a substantial number of small entities for the following reasons. Vessel traffic can pass safely around the safety zone. Before the effective period, the Coast Guard will publish a local notice to mariners (LNM) and will issue broadcast notice to mariners (BNM) alerts via marine channel 16 VHF before the safety zone is enforced.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

On January 26, 2011 (76 FR 4579), EPA published a notice of proposed rulemaking (NPR) for the Commonwealth of Virginia. The NPR proposed approval of Virginia's SIP revision pertaining to the NAAQS for lead and related reference conditions. The CAA specifies that EPA must re-evaluate the appropriateness of the NAAQS every five years. As part of the process, EPA reviewed the latest research and determined that revised standards for lead were necessary to protect public health and welfare. EPA revised the level of the primary lead standard to a level of 0.15 μg/m 3 to provide increased protection for children and other “at risk” populations. The secondary standard was also revised to a level of 0.15 μg/m 3 to afford increased protection for the environment. EPA promulgated the more stringent primary and secondary NAAQS for lead on November 12, 2008 (73 FR 66964). One adverse comment was submitted on EPA's January 26, 2011 NPR (76 FR 4579). A summary of the comment and EPA's response is provided in section IV of this document.

On September 27, 2010, the Commonwealth of Virginia submitted a formal revision to its SIP. The SIP revision consists of an amendment which includes the revised primary and secondary NAAQS for lead and related reference conditions. Virginia's revision incorporates the Federal lead standards into the Code of Virginia (9VAC5 Chapter 30). In addition, the list of appendices to 40 CFR Part 51 was updated under “Documents Incorporated by Reference” (9VAC5-20-21).

The following are the specific sections that are being modified or amended:

• 9VAC5-20-21: Documents Incorporated by Reference (modified)

• 9VAC5-30-15: Reference Conditions (modified)

• 9VAC5-30-80: Lead (amended)

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

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

Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that “[t]o the extent consistent with requirements imposed by Federal law,” any person making a voluntary disclosure of information to a state agency regarding a violation of an environmental statute, regulation, permit, or administrative order is granted immunity from administrative or civil penalty. The Attorney General's January 12, 1998 opinion states that the quoted language renders this statute inapplicable to enforcement of any Federally authorized programs, since “no immunity could be afforded from administrative, civil, or criminal penalties because granting such immunity would not be consistent with Federal law, which is one of the criteria for immunity.” Therefore, EPA has determined that Virginia's Privilege and Immunity statutes will not preclude the Commonwealth from enforcing its program consistent with the Federal requirements. In any event, because EPA has also determined that a state audit privilege and immunity law can affect only state enforcement and cannot have any impact on Federal enforcement authorities, EPA may at any time invoke its authority under the CAA, including, for example, sections 113, 167, 205, 211 or 213, to enforce the requirements or prohibitions of the state plan, independently of any state enforcement effort. In addition, citizen enforcement under section 304 of the CAA is likewise unaffected by this, or any, state audit privilege or immunity law. Other specific requirements and the rationale for EPA's proposed action are explained in the NPR and will not be restated here. As noted below, EPA received one comment on the NPR and it was not germane.

Comment: A small business owner expressed concern about having additional costs imposed upon individuals who work on lead paint-containing homes built before 1978. The commenter stated that the business climate cannot support another regulation and expressed concern about being able to remain in business with the adoption of this rule.

Response: This comment is not relevant to this rulemaking action. The commenter discusses lead as it relates to lead-containing paints and the requirement for its removal in homes built prior to 1978. This action imposes no requirements with respect to the removal of lead-containing paint from homes built prior to 1978. This action is concerned with the adoption of the 2008 lead NAAQS by the Commonwealth of Virginia into the Commonwealth's SIP.

EPA is approving Virginia's SIP revision for the lead NAAQS and related reference conditions, as well as the updated list of appendices to 40 CFR part 51 under documents incorporated by reference.

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 June 24, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action pertaining to Virginia's adoption of the revised lead standards of 0.15 μg/m 3 and related reference conditions may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

40 CFR Part 52 is amended as follows:

Each state has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.

Each state must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the SIP to EPA. Once these control measures and strategies are approved by EPA, after notice and comment, they are incorporated into the federally approved SIP and are identified in part 52 “Approval and Promulgation of Implementation Plans,” Title 40 of the CFR (40 CFR part 52). The full text of the state regulation approved by EPA is not reproduced in its entirety in 40 CFR part 52, but is “incorporated by reference.” This means that EPA has approved a given state regulation with a specific effective date. The public is referred to the location of the full text version should they want to know which measures are contained in a given SIP. The information provided allows EPA and the public to monitor the extent to which a state implements a SIP to attain and maintain the NAAQS and to take enforcement action if necessary.

The SIP is a living document which the state can revise as necessary to address the unique air pollution problems in the state. Therefore, EPA from time to time must take action on SIP revisions containing new and/or revised regulations as being part of the SIP. On May 22, 1997 (62 FR 27968), EPA revised the procedures for incorporating by reference, into the CFR, materials submitted by states in their EPA-approved SIP revisions. These changes revised the format for the identification of the SIP in 40 CFR part 52, streamlined the mechanisms for announcing EPA approval of revisions to a SIP, and streamlined the mechanisms for EPA's updating of the IBR information contained for each SIP in 40 CFR part 52. The revised procedures also called for EPA to maintain “SIP Compilations” that contain the federally approved regulations and source specific permits submitted by each state agency. These SIP Compilations are contained in 3-ring binders and are updated primarily on an annual basis. Under the revised procedures, EPA is to periodically publish an informational document in the rules section of the Federal Register when updates are made to a SIP Compilation for a particular state. EPA's 1997 revised procedures were formally applied to South Carolina on July 1, 1997 (62 FR 35441).

This action represents EPA's publication of the South Carolina SIP Compilation update, appearing in 40 CFR part 52. In addition, notice is provided for the following typographical corrections to Tables (c), (d), and (e) of paragraph 52.2120, as described below:

EPA has determined that today's action falls under the “good cause” exemption in the section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make an action effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). Today's administrative action simply codifies provisions which are already in effect as a matter of law in Federal and approved state programs and corrects typographical errors appearing the Federal Register . Under section 553 of the APA, an agency may find good cause where procedures are “impractical, unnecessary, or contrary to the public interest.” Public comment for this administrative action is “unnecessary” and “contrary to the public interest” since the codification (and typographical corrections) only reflect existing law. Immediate notice of this action in the Federal Register benefits the public by providing the public notice of the updated South Carolina SIP Compilation and notice of typographical corrections to the South Carolina “Identification of Plan” portion of the Federal Register .

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this administrative action is not a “significant regulatory action” and is therefore not subject to review by the Office of Management and Budget. This action is not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a significant regulatory action under Executive Order 12866. Because the Agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the APA or any other statute as indicated in the SUPPLEMENTARY INFORMATION section above, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C 601 et seq. ), or to sections 202 and 205 of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). In addition, this action does not significantly or uniquely affect small governments or impose a significant intergovernmental mandate, as described in sections 203 and 204 of UMRA.

This administrative action also does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

This administrative action also is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it is not economically significant. This administrative action does not involve technical standards; thus the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. The administrative action also does not involve special consideration of environmental justice related issues as required by Executive Order 12898 (59 FR 7629, February 16, 1994). This administrative action does not impose an information collection burden under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ). EPA's compliance with these Statutes and Executive Orders for the underlying rules are discussed in previous actions taken on the State's rules.

The Congressional Review Act (CRA) (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. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. Today's administrative action simply codifies (and corrects) provisions which are already in effect as a matter of law in Federal and approved state programs. 5 U.S.C. 808(2). These announced actions were effective when EPA approved them through previous rulemaking actions. 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 this action in the Federal Register . This update to South Carolina's SIP Compilation and correction of typographical errors is not a “major rule” as defined by 5 U.S.C. 804(2).

EPA has also determined that the provisions of section 307(b)(1) of the Clean Air Act pertaining to petitions for judicial review are not applicable to this action. This action is simply an announcement of prior rulemakings that have previously undergone notice and comment rulemaking. Prior EPA rulemaking actions for each individual component of the South Carolina SIP compilation previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action.

40 CFR part 52, is amended as follows:

Sections 111(d) and 129 of the CAA require submittal of plans to control certain pollutants (designated pollutants) at existing solid waste combustion facilities (designated facilities) whenever standards of performance have been established under section 111(d) for new sources of the same type, and EPA has established emission guidelines for such existing sources. A designated pollutant is any pollutant for which no air quality criteria have been issued, and which is not included on a list published under section 108(a) or section 112(b)(1)(A) of the CAA, but emissions of which are subject to a standard of performance for new stationary sources.

Standards of performance for new LMWC units and emission guidelines for all existing LMWC units (designated facilities) constructed on or before September 20, 1994, have been established by EPA. The emission guidelines were promulgated on December 19, 1995 (60 FR 65415), and amended most recently on May 10, 2006 (71 FR 27324). The emission guidelines are codified at 40 CFR part 60, subpart Cb.

Standards of performance for new SMWC units and emission guidelines for all existing SMWC units (designated facilities) constructed on or before August 30, 1999, have been established by EPA. The emission guidelines were promulgated on December 6, 2000 (65 FR 76384). The emission guidelines are codified at 40 CFR part 60, subpart BBBB.

Standards of performance for new HMIWI units and emission guidelines for all existing HMIWI units (designated facilities) constructed on or before June 20, 1996, have been established by EPA. The emission guidelines were promulgated on September 15, 1997 (62 FR 48348), and amended most recently on October 6, 2009 (74 FR 51366). The emission guidelines are codified at 40 CFR part 60, subpart Ce.

Standards of performance for new OSWI units and emission guidelines for all existing OSWI units (designated facilities) constructed on or before December 9, 2004, have been established by EPA. The emission guidelines were promulgated on December 16, 2005 (70 FR 74870), and amended most recently on January 22, 2007 (72 FR 2620). The emission guidelines are codified at 40 CFR part 60, subpart FFFF.

Federal regulations found in subpart B of 40 CFR part 60 establish procedures to be followed and requirements to be met in the development and submission of state plans for controlling designated pollutants at designated facilities. Federal regulations found in subpart A of 40 CFR part 62 provide the procedural framework for the submission of these plans. When designated facilities are located under the jurisdiction of a state, or local agency, the state or local agency must then develop and submit a plan for their respective jurisdiction for the control of the designated pollutants. However, the federal regulations found at 40 CFR 62.06 provide that if there are no existing sources of the designated pollutants within the state or local agency jurisdiction, the state or local agency may submit a letter of certification to that effect, or negative declaration, in lieu of a plan. The negative declaration exempts the state or local agency from the requirements to submit a plan for that designated pollutant.

EPA has received several negative declaration letters for Sections 111(d) and 129 source categories from state and local air pollution agencies. The Florida Department of Environmental Protection has determined that there are no existing OSWI units in its jurisdiction. The Louisville, Kentucky, Air Pollution Control District has determined that there are no existing LMWC, SMWC or OSWI units within its jurisdiction, Jefferson County, Kentucky. The South Carolina Department of Health and Environmental Control has determined that there are no existing LMWC or HMIWI units within its jurisdiction. The Forsyth County Environmental Affairs Department has determined that there are no existing LMWC, SMWC or OSWI units within its jurisdiction, Forsyth County, North Carolina. The Mecklenburg County Land Use and Environmental Services Agency has determined that there are no existing LMWC, SMWC or OSWI units within its jurisdiction, Mecklenburg County, North Carolina. The Western North Carolina Regional Air Quality Agency has determined that there are no existing LMWC, SMWC, HMIWI or OSWI units within its jurisdiction, Buncombe County, North Carolina. Pursuant to 40 CFR part 60, EPA is providing the public with notice of these negative declarations. Notice of these negative declarations will appear at 40 CFR part 62.

Under the CAA, the Administrator is required to approve a 111(d)/129 plan 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 111(d)/129 plan 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).

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 June 24, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's Federal Register , rather than file an immediate petition for judicial review of this direct final rule, so that EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2)).

40 CFR part 62 is amended as follows:

I. Background Information

The EPA published Subpart W: Petroleum and Natural Gas Systems of the Greenhouse Gas Reporting Rule on November 30, 2011, 40 CFR Part 98, Subpart W (75 FR 74458)(Subpart W). Included in the final rule were new provisions allowing owners or operators the option of using best available monitoring methods for specified parameters in 40 CFR 98.233. Subpart W provides that owners or operators wishing to use BAMM during 2011 for emissions sources listed in 40 CFR 98.234(f)(4)or 98.234(f)(5)(iv) must submit BAMM applications by April 30, 2011. In addition, subpart W provides that owners or operators with emissions sources listed in 40 CFR 98.234(f)(2) or 40 CFR 98.234(f)(3) have the option of using BAMM from January 1, 2011 to June 30, 2011 without submitting a request to the Administrator for approval to use BAMM; however to extend use of BAMM beyond June 30, 2011, those owners or operators must submit a request to the Administrator by April 30, 2011.

Following the publication of Subpart W in the Federal Register , several industry groups sought reconsideration of several provisions in the final rule, including the provisions requiring submittal of BAMM requests for use or extension of BAMM in calendar year 2011 by April 30, 2011, and the time period for which owners or operators of sources in 40 CFR 98.234(f)(2) or 40 CFR 98.234(f)(3) would not be required to submit a BAMM request to the Administrator for approval, i.e., January 1 through June 30, 2011.

By letter dated January 31, 2011, the American Petroleum Institute (API) stated that “[a]ggressive deadlines for BAMM are problematic for reporters who are attempting to monitor GHG emissions for the first time. In particular, the April 30, 2011 deadline for BAMM requests does not provide reporters sufficient time to identify the sources for which BAMM should be requested and gather the data that EPA requires be submitted with a BAMM request.” API, along with the Gas Processors Association (GPA), Interstate Natural Gas Association of America (INGAA), Chesapeake Energy Corporation (CEC)/American Exploration & Production Council (AXPC), stated that they would not be able to complete an initial assessment of their facilities to determine whether they would need BAMM by the deadline of April 30, 2011. Further, a subset of these petitioners further noted that the time period for which owners and operators were granted the optional use of BAMM without being required to submit a request to the Administrator for approval was insufficient for them to make the necessary assessment of their facilities to determine compliance with the rule.

EPA believes that pursuant to CAA section 307(d)(7)(B) it is appropriate to extend the deadlines in 40 CFR 98.234(f)(5)(iii)(A), 98.234(f)(5)(iv)(A), 98.234(f)(6)(i), and 98.234(f)(7)(i) by three months, to allow owners and operators additional time to assess which of their facilities would need to take advantage of the BAMM provisions of Subpart W for calendar year 2011. EPA also believes that pursuant to CAA section 307(d)(7)(B) it is appropriate to extend the deadlines, by three months, by which owners and operators of emission sources listed in 40 CFR 98.234(f)(2) or 40 CFR 98.234(f)(3), would have the option to use BAMM without submitting a request for approval from the Administrator to allow additional time to asses applicability of the rule provisions to their facilities. EPA is taking no action at this time on other issues raised by petitioners in their respective Petitions for Reconsideration and reserves the right to further consider those issues at a later time.

Pursuant to Clean Air Act (CAA) section 307(d)(7)(B), EPA is extending the deadlines in 40 CFR 98.234(f)(5)(iii)(A), 98.234(f)(5)(iv)(A), 98.234(f)(6)(i), and 98.234(f)(7)(i) for three months, i.e., until July 31, 2011.

Further, pursuant to CAA section 307(d)(7)(B) EPA is also extending the deadlines contained in 40 CFR 98.234(f)(2), 40 CFR 98.234(f)(3), 40 CFR 98.234(f)(5)(i), 40 CFR 98.234(f)(5)(ii), 40 CFR 98.234(f)(6), 40 CFR 98.234(f)(6)(ii)(D), 40 CFR 98.234(f)(6)(iii), 40 CFR 98.234(f)(7), and 40 CFR 98.234(f)(7)(iii) for three months, i.e., until September 30, 2011.

Section 553 of the Administrative Procedure Act, 5 U.S.C. 553(b)(B), provides that, when an agency for good cause finds that notice and public procedure are impracticable, unnecessary or contrary to the public interest, the agency may issue a rule without providing notice and an opportunity for public comment. EPA has determined that there is good cause for making today's rule final without prior proposal and opportunity for comment. We are acting pursuant to CAA section 307(d)(7)(B) to extend these deadlines in part because both the affected universe of facilities subject to the rule and the substantive requirements associated with the BAMM provisions in the rule could change as a result of this reconsideration process. In addition, we are extending these provisions to allow owners and operators of affected facilities additional time to appropriately assess their facilities to determine if it will be necessary for them to apply for BAMM during calendar year 2011. Because we cannot predict the resulting outcome of the reconsideration process with respect to BAMM, we think a limited extension during the duration of the administrative reconsideration process is appropriate so that owners and operators of affected facilities would not incur additional costs associated with applying for BAMM in advance of our final decision on this issue. It would be impracticable to go through notice and comment rulemaking to extend an imminent deadline and it is also unnecessary because section 307(d)(7)(B) does not require notice and comment for a three-month extension pending reconsideration. Thus, notice and public procedure are impracticable and unnecessary. EPA finds that this constitutes good cause under 5 U.S.C. 553(b)(B).

This action is not a ”significant regulatory action,” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and, therefore, not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). For this reason, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). In addition, because the agency has made a “good cause” finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute (See Section I. Background Information of this preamble) it is not subject to sections 202 and 205 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4). In addition, this action does not impose any enforceable duty or contain any unfunded mandates as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), or require prior consultation with State officials, as specified by Executive Order 12875 (58 FR 58093, October 28, 1993), or involve special consideration of environmental justice related issues, as required by Executive Order 12898 (59 FR 7629, February 16, 1994). Further, because the agency has made a “good cause” (See Section I. Background Information of this preamble) finding that this action is not subject to notice-and-comment requirements under the Administrative Procedure Act or any other statute, it is not subject to the regulatory flexibility provisions of the Regulatory Flexibility Act (5 U.S.C. 601, et seq. ). This action also does not have Tribal implications because it will not have a substantial direct effect on one or more Indian Tribes, on the relationship between the Federal government and Indian Tribes, or on the distribution of power and responsibilities between the Federal government and Indian Tribes, as specified by Executive Order 13175 (65 FR 67249, November 9, 2000). This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). The requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This action does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501, et seq. ). EPA's compliance with these statutes and Executive Orders for the underlying rule is discussed in the November 30, 2010 Federal Register document.

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefore, and established an effective date of April 30, 2011. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

This Federal Register notice is available in the docket for the final rule titled “Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems,” published on November 30, 2010 at 98 FR 74458, under Docket ID No. EPA-HQ-OAR-2009-0923.

All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information may not be publicly available, i.e., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at the EPA's Docket Center, Docket ID No. EPA-HQ-OAR-2009-0923, Public Reading Room, EPA West Building, Room 3334, 1301 Constitution Avenue, Northwest, Washington, DC 20004. This Docket Facility is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the Air Docket Center is (202) 566-1741.

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

For the reasons discussed in the preamble, the EPA amends 40 CFR parts 98 as follows: