FSIS implements the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ) to protect the health and welfare of consumers by preventing the distribution in commerce of meat or poultry products that are unwholesome, adulterated, or misbranded. To reduce the risk of foodborne illness from meat or poultry products, FSIS issued regulations on July 25, 1996, that require that federally inspected establishments adopt HACCP systems (61 FR 38806). These regulations require that federally inspected establishments adopt measures to prevent or control the occurrence of food safety hazards at each stage of the production process where such hazards are reasonably likely to occur.

The HACCP regulations in 9 CFR part 417 require that each establishment conduct a hazard analysis to determine the food safety hazards reasonably likely to occur in its production process and to identify the preventive measures the establishment can apply to control those hazards in the production of particular products (9 CFR 417.2(a)). Whenever a hazard analysis reveals one or more food safety hazards reasonably likely to occur in the production process, the HACCP regulations require that the establishment develop and implement a written HACCP plan, for each product, that includes specified measures to prevent, eliminate, or reduce to an acceptable level the effects of each hazard so identified (9 CFR 417.2(b)(1) and 9 CFR 417.2(c)). The regulations in 9 CFR 417.2(c) require, among other things, that the HACCP plan include CCPs at which such measures can be applied.

The HACCP regulations in 9 CFR part 417 also require that establishments validate the HACCP plan's adequacy to control the food safety hazards identified by the hazard analysis (9 CFR 417.4(a)). The regulations in 9 CFR 417.4(a)(1) prescribe requirements for the initial validation of an establishment's HACCP plan and require establishments to “conduct activities designed to determine that the HACCP plan is functioning as intended.” During this initial validation period, establishments are to “repeatedly test the adequacy of the CCPs, critical limits, monitoring and recordkeeping procedures, and corrective actions” prescribed in their HACCP plans (9 CFR 417.4(a)(1)). The regulations state that “[v]alidation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities” (9 CFR 417.4(a)(1)).

After an establishment has validated its HACCP plan, the regulations require that it conduct ongoing verification activities and reassess the HACCP plan at least annually or whenever a change occurs that could affect its hazard analysis or HACCP plan (9 CFR 417.4(a)(2) and 9 CFR 417(a)(3)).

The regulations in 9 CFR 417.5 require that establishments maintain certain records that document their HACCP plans. In addition to records associated with the HACCP plan itself, these records must include the written hazard analysis prescribed in 9 CFR 417.2(a), including supporting documentation (9 CFR 417.5(a)(1)).

Initial validation period. Validation is the process of demonstrating that a HACCP system, if operating as designed, can adequately control identified hazards to produce a safe product. As discussed above, the regulations in 9 CFR 417.4(a)(1) provide for an initial validation period during which meat and poultry product establishments are to conduct activities to validate their HACCP systems. Official meat and poultry product establishments that were in operation when FSIS issued its HACCP regulations in part 417 were required to conduct this initial validation when they became subject to part 417.

Since FSIS issued its HACCP regulations, meat and poultry product establishments have been required to conduct a hazard analysis and develop and validate a HACCP plan in accordance with 9 CFR 417.2 and 9 CFR 417.4 as a condition for receiving Federal inspection (9 CFR 304.3(b) and 9 CFR 381.22(b)). The regulations provide for the issuance of a conditional grant of inspection for a period not to exceed 90 days during which time the establishments are to complete their initial HACCP plan validation.

In addition, if an establishment decides to produce a new product for distribution in commerce, it is required to conduct a hazard analysis and develop a HACCP plan applicable to that product before introducing it into commerce (9 CFR 304.3(c) and 381.2(c)). The establishment is required to complete the initial validation of the new HACCP plan in accordance with 9 CFR 417.4 during a period not to exceed 90 days after the date the new product is produced for distribution in commerce.

HACCP system records reviews. The regulations in 9 CFR 417.4(a) identify certain activities that an establishment is required to complete to validate its HACCP plans. These regulations state, among other things, that validation is to encompass “reviews of the records, routinely generated by the HACCP system, in the context of the validation.” The “HACCP system” is defined as “[t]he HACCP plan in operation, including the HACCP plan itself” (9 CFR 417.1). Thus, HACCP plan validation under 9 CFR 417.4(a)(1) requires that an establishment conduct reviews of both the records required in the HACCP plan, as well as required records generated by the HACCP plan in operation.

The operation of a HACCP plan involves all activities performed by the establishment to prevent or control food safety hazards identified in the hazard analysis. An establishment may perform these activities as part of its HACCP plan or as part of a program that contains interventions or controls that could affect the hazard analysis but that may or may not be referenced in the HACCP plan. For example, an establishment may conduct activities to address an identified hazard as part of a prerequisite program or as part of a program to comply with specifications of a business customer. Because the results obtained under these programs could affect decisions made in the hazard analysis, an establishment is required to maintain records associated with these programs as supporting documentation for its hazard analysis (9 CFR 417.5(a)).

The written hazard analysis and supporting documentation are among the records required under 9 CFR 417.5 to document the HACCP plan and, as such, are also among the records “routinely generated by the HACCP system” subject to review for validation under 9 CFR 417.4(a)(1). Thus, if an establishment's supporting documentation for its hazard analysis includes records associated with a prerequisite program that provides for an intervention or process designed to prevent a hazard from being likely to occur, the records required for validation under 9 CFR 417.4(a)(1) would need to cover all documents associated with the prerequisite program. An establishment must assess whether these records demonstrate that the intervention or control provided for in the program can achieve results that support decisions in the hazard analysis that a hazard is not reasonably likely to occur because of the operation of the program.

Elements of validation. Validation under 9 CFR 417.4(a)(1) requires that establishments assemble two types of data: (1) The scientific or technical support for the judgments made in designing the HACCP system, and (2) evidence derived from the HACCP plan in operation to demonstrate that the establishment is able to implement the critical operational parameters necessary to achieve the results documented in the scientific or technical support.

Establishing and documenting the scientific or technical basis for the HACCP system requires that the establishment gather scientific or technical documentation demonstrating that the measures adopted in its HACCP system are effective in controlling identified food safety hazards. Scientific or technical support for a HACCP system may consist of Agency guidance documents, documented expert advice from processing authorities, an article from a peer-reviewed journal, a documented scientific study, documented results from a pathogen modeling program, or analogous information. To be effective, the scientific documentation should identify: (1) The hazard that the measures are intended to address; (2) the expected level of hazard reduction or prevention that the measures will achieve; (3) the critical operational parameters, such as time, temperature, humidity, and pH, that must be met for the measures to be effective; (4) the processing steps necessary to achieve the specified level of hazard reduction or prevention; and (5) how the processing steps can be monitored.

For example, for scientific support of its HACCP system, an establishment that processes beef carcasses may use a published journal article that describes the use of a lactic acid spray system as an antimicrobial intervention. To meet the first element of validation, the journal article should identify E.coli O157:H7 and other pathogens as the hazard that the lactic acid intervention is intended to address and should specify the level of pathogen reduction that the intervention is capable of achieving. The article should identify the critical operational parameters needed for the intervention to be effective, such as the design of the spray cabinet, the concentration of the lactic acid, the pressure at which the spray is delivered, the temperature of the acid at the point of delivery, and the temperature of the carcass when the acid is applied.

Once an establishment has satisfactorily documented the scientific or technical support for its HACCP system, the regulations require that it “repeatedly test the adequacy” of the various components of its HACCP plan in controlling identified hazards (9 CFR 417.4(a)(1)). This element of the validation process requires that the establishment demonstrate that the system will actually perform as expected. An establishment must develop data to demonstrate that it has and can routinely meet the scientifically documented parameters in its HACCP systems under in-plant conditions, i.e., with its own employees and equipment, and that its HACCP system, as implemented, is capable of achieving the expected results. Data used to support this in-plant demonstration may include in-plant observations, measurements, microbiological test results, documentation to demonstrate that employees have been properly trained regarding the important aspects of their duties, or other information to demonstrate that the establishment can implement the preventive or control measures, as written into the HACCP system, in a manner that achieves the intended food safety objective.

For example, an establishment that has incorporated the use of a lactic acid spray intervention described in a peer-reviewed journal article into its HACCP system will need to assemble documentation to demonstrate that it is capable of following the procedures in the same manner in which they are described in the study. To conduct the in-plant demonstration, the establishment will need to measure and record the results for all critical operational parameters identified in the study, such as the concentration of the lactic acid spray, the pressure of the spray, the temperature of the lactic acid, and the temperature of the carcass at the point of delivery. The lactic acid intervention will be validated if, at the end of 90 days, the establishment has assembled data demonstrating that the establishment is consistently meeting all critical operating parameters documented in the scientific study under in-plant conditions.

As discussed above, an establishment must validate all measures that it relies upon to prevent or control the hazards that it has identified in its HACCP system, whether the measures are part of the establishment's HACCP plan itself or part of a program that includes interventions or controls that affect the hazard analysis. Under FSIS's regulations, these measures are not considered to be validated until the establishment has satisfied both elements described above.

For example, an establishment that receives, grinds, or otherwise processes ground beef may determine that E. coli O157:H7 is not a hazard reasonably likely to occur in its production process because it has a prerequisite program incorporating purchase specifications that require that the establishment's suppliers apply validated interventions to address E. coli O157:H7 on the product that they send the establishment. The establishment may reference the documentation provided by the supplier as the support for the prerequisite program. However, the prerequisite program is not validated until the receiving establishment has documentation from each supplier, such as a letter of guarantee, that assures that the supplier employs CCPs that address E. coli O157:H7, describes those CCPs and the method of monitoring of them and provides certificates of analysis that specify the sampling method that the supplier uses and the results of that sampling. The receiving establishment should also do its own testing or visit the supplier's establishment to confirm that the supplier is executing the purchase specifications in a consistent and effective manner to ensure that the product the supplier sends does not contain detectable levels of E. coli O157:H7. If the receiving establishment visits the supplier, the receiving establishment should develop and maintain records that document the findings of such visits.

As noted in the preamble to the HACCP final rule, adequate validation needs to include both supporting scientific information as well as in-plant operational data to “* * * demonstrate not only that [the establishment's] HACCP plan is theoretically sound, but also that this establishment can implement it and make it work” (61 FR 38806, 38826).

FSIS developed an initial draft guidance document in 2010 to assist the industry, particularly small and very small establishments, in complying with the requirements for HACCP systems pursuant to 9 CFR 417.4. FSIS made this initial draft guidance available to the public in March 2010 by posting it on the FSIS Web site and announcing its availability in the Constituent Update. The Agency also mailed the guidance document to all federally-inspected meat and poultry product establishments.

The initial draft guidance described the types and sources of scientific information that establishments can use to meet the first element of the validation requirement, the scientific or technical support. It also described the types of observational data and in-plant measurements that establishments can use to meet the second element of validation, the in-plant demonstration. The guidance also explained that, in addition to gathering observational data, in-plant validation requires demonstrating that the array of interventions and process steps together in sequence are achieving the desired result. The guidance included an Appendix titled “Validation Examples for Raw Products and Processed Products” that provided examples on the kinds of data that establishments could use to meet the validation requirement.

With respect to the types of data that would be appropriate to demonstrate that an establishment's HACCP system was achieving the desired result, the initial draft guidance stated that:

“FSIS believes that microbiological testing that combines enumeration of indicators with the presence/absence of an identified pathogen in conjunction with monitoring critical parameters plays an important role in the initial validation of many interventions for biological food safety hazards. Microbiological testing data, where appropriate, can provide establishments information about whether the overall system of interventions can achieve the desired log reductions documented in the scientific supporting documentation. Establishments would need to provide support in instances where they believe microbiological testing data is not needed to demonstrate the effectiveness of the HACCP system in controlling biological food safety hazards. Once the operational effectiveness of each individual intervention is determined, the establishment can use microbiological testing data in conjunction with the data on the individual interventions to establish that the process as a whole results in the production of safe, unadulterated product. In this final part of step 2 initial in-plant validation, the establishment should pull together the data for each intervention and the data from microbiological testing at various points throughout the HACCP system to ensure that the multiple hurdle design of its entire HACCP system will result in the production of safe, unadulterated products. Failure to take these steps will raise questions whether the HACCP system has been adequately validated.”

An array of issues were raised in comments submitted in response to the initial draft guidance, particularly with respect to the guidance on the use of microbiological testing to validate the effectiveness of HACCP systems in controlling biological hazards. To address these issues, the Agency developed, and made available on its Web site, a supplemental fact sheet to assist small and very small meat and poultry establishments obtain information to support the scientific design of their HACCP systems ( http://www.fsis.usda.gov/Science/HACCP_Validation/index.asp ).

In addition, on June 14, 2010, FSIS held a public meeting to discuss the draft HACCP validation guidance and received input from stakeholders.

The transcripts of the July 2010 public meeting are available on the FSIS Web site at: http://www.fsis.usda.gov/PDF/Transcripts_HACCP_Validation_061410.pdf.

FSIS received over 2000 comments on its March 2010 draft guidance on HACCP validation from consumers of organic meat and poultry, small livestock producers and family farmers, small and very small meat or poultry processors, trade associations representing meat and poultry processors, trade associations representing animal producers, State Departments of Agriculture and other local or State government officials, academics, insurance companies, and consumer advocacy organizations.

FSIS has carefully considered the comments and re-evaluated its draft guidance in light of these comments. Based on this re-evaluation, FSIS has revised the draft guidance. Following is a brief summary and discussion of the major issues raised by the comments.

Comment: FSIS received a significant number of comments on the use of microbiological testing to validate a HACCP system. The majority of these comments objected to the requirements for microbiological testing as part of the in-plant demonstration component of validation. The comments stated that the benefit of collecting microbial data is unclear and is not justified by the significant financial burden that such testing would impose.

A number of comments stated that instead of requiring microbiological testing, the focus of in-plant validation should be on critical operating parameters. The comments asserted that a scientific study is the safest and most effective method to validate a process, and that the in-plant validation should be focused on collecting data to demonstrate that the establishment is properly implementing the procedures described in the scientific support, allowing establishments to focus on meeting the established parameters.

Response: FSIS agrees and has revised the draft guidance to remove the references to the use of in-plant microbiological testing as a necessary part of the in-plant demonstration component of the HACCP validation process. FSIS has concluded that a key focus of validation should be on the establishment's ability to achieve the scientifically supported critical operating parameters under in-plant conditions. A showing that the establishment can effectively achieve these parameters will satisfy the in-plant demonstration requirements of validation and fulfill the objectives of the HACCP regulations without imposing significant costs on small businesses.

Accordingly, the in-plant demonstration of validation will be considered effective when an establishment has demonstrated that it is capable of effectively implementing the critical operational parameters identified in the establishment's scientific or technical support.

Although references to microbiological testing in the initial in-plant validation phase have been removed from the revised compliance guidance, FSIS will continue to include establishments that are conducting the initial validation in the Agency's regulatory microbiological sampling programs. FSIS would question the adequacy of an establishment's HACCP system if regulatory samples analyzed by the Agency show non-compliance with microbiological standards.

Comment: Some comments pointed out that all parameters specified in an establishment's supporting scientific and technical documentation may not in fact be needed for the intervention or control measure to be effective. The comments asserted that meeting only the critical parameters necessary to successfully implement an intervention should be required as part of the in-plant demonstration.

Response: As noted above, FSIS has revised the guidance to focus on the critical operational parameters. The critical operating parameters are those that have been shown to influence the effectiveness of an intervention when variations occur. If some of the operational parameters described in the scientific support have been found to have no impact on the effectiveness of the intervention, there would be no need to monitor those operational parameters during the initial validation period.

Comment: Some comments suggested that FSIS create safe harbors for establishments in which they can operate without concerns about the validity of their process. The comments stated that the Agency should only request in-plant information from an establishment when the validity of the process is being questioned, or if the establishment is implementing a new or unique process.

Several comments submitted by the industry stated that HACCP plans are backed by scientific studies that have been conducted by a university, trade association, or a regulatory body. The comments stated that these scientific studies validate that an establishment's HACCP plan is capable of producing a safe product.

Response: Establishments may use established processing guidelines, such as Appendix A of the final rule “Performance Standards for the Production of Certain Meat and Poultry Products,” for their scientific support. The parameters established in these guidelines would be considered “safe harbors.” However, the establishment would still need to collect in-plant data to demonstrate that is capable of achieving the critical operational parameters documented in these processing guidelines to complete the validation.

The regulations that prescribe requirements for validation require that establishments “* * * repeatedly test the adequacy of the CCPs, critical limits, monitoring and recordkeeping procedures, and corrective actions” described in their HACCP plans (9 CFR 417.4(a)(1)). While a scientific study may demonstrate that the HACCP system is designed to effectively address the relevant hazards, additional in-plant monitoring and observation is needed to demonstrate that the system will function as designed. Thus, a scientific study on its own is not sufficient to validate an establishment's HACCP system.

Comment: One trade association asked how the Agency will work to ensure that small and very small plants have access to the scientific support mentioned in the guidance document.

Response: FSIS has posted a list of relevant journal articles by pathogen on its Web site ( http://www.fsis.usda.gov/Science/HACCP_Validation_Articles/index.asp ). The Agency is also developing a tutorial on understanding scientific and technical journal articles and identifying critical operational parameters. FSIS will post that material on the Web site when it is complete.

Comment: Several comments expressed concern about requiring that establishments implement regular, year-round microbiological testing, regardless of whether problems have been identified. The comments also expressed concern about the annual cost for ongoing in-plant testing.

Response: The concerns about ongoing or year-round testing expressed by the comments are related to the on-going verification that is required after the validation is complete. After an establishment completes the initial validation, it is required to conduct verification activities to demonstrate that it continues to achieve the critical operating parameters on an on-going basis. The draft guidance does note that these on-going verification procedures may need to include microbiological testing, although establishments may use a number of measures including ongoing communication with suppliers and third party audits, to support the HACCP system is functioning as intended on an ongoing basis.

Comment: Some comments submitted by trade associations representing meat and poultry processors stated that FSIS needs to ensure that its field personnel interpret the validation guidance in an accurate and consistent manner. The comments suggested that FSIS conduct workshops and training sessions on the validation guidance for industry and inspection personnel.

Response: FSIS will provide instructions to the field when it issues final guidance on HACCP validation. The Agency also will provide additional materials and supplemental training to ensure that the validation requirements are properly implemented.

Comment: Several comments emphasized the importance of recognizing that a “one size fits all” approach to regulatory requirements is not the most effective approach. Some comments suggested that FSIS should establish a separate set of requirements for small processors, or perhaps exempt small processors from the HACCP validation requirements.

Response: FSIS agrees that it is important to provide small and very small establishments the flexibility they need to comply with regulatory requirements. At the same time, in order to ensure that meat and poultry products are safe, wholesome, and accurately labeled, it is essential for all establishments to effectively validate their HACCP systems. The revised draft guidance provides small and very small plants the flexibility to choose the most appropriate procedures for them to achieve the requirements for HACCP validation. In addition, FSIS will continue to assist small and very small plants in meeting the regulatory requirements for HACCP through the Agency's ongoing small and very small plant outreach activities.

Comment: One industry commenter asked whether a company that owns more than one establishment can use the validation data gathered from one facility to validate the HACCP systems of other facilities owned by the same company.

Response: Both the initial guidance document and our revised draft guidance explain that if a company owns multiple establishments that conduct the same operations, the establishments may use the same scientific support for all establishments to satisfy the first element of validation. However, each establishment would need to conduct its own on-site study to demonstrate that it is capable of meeting the critical operational parameters in the scientific study. It is important that each establishment do so because variations exist from establishment to establishment, such as differences in equipment configurations or building structures, which could have an impact on the implementation of a measure documented in the scientific support.

After careful consideration of the comments submitted on the March 2010 initial draft guidance, the Agency revised its draft guidance on HACCP systems validation. Following is a summary of major areas that FSIS addressed when it revised the draft guidance.

Scientific Support. As part of its HACCP verification activities, in addition to the issues related to the in-plant demonstration described above, FSIS has identified instances in which an establishment's HACCP system design did not reflect the critical operational parameters documented in the scientific or technical support. Therefore, the revised draft guidance provides additional recommendations on measures that an establishment can take to ensure that its scientific or technical support is properly applied to its production process and the hazards identified in the hazard analysis. The guidance emphasizes that to be effective, the establishment's HACCP system design must relate and adhere to the specifications in the supporting documentation.

The revised draft guidance also discusses the five major types of scientific support. These include: (1) Published processing guidelines, e.g. Appendix A of the final rule “Performance Standards for the Production of Certain Meat and Poultry Products” and Appendix B, Compliance Guidelines for Cooling Heat-Treated Meat and Poultry Products (Stabilization); (2) a scientific article from a peer-reviewed journal; (3) a challenge or inoculated pack study that is designed to determine the lethality or stabilization of a process; (4) data gathered in-house; and (5) regulatory performance standards.

The revised draft guidance recommends that scientific support contain microbiological data that specifies the level of pathogen reduction that an intervention for a target pathogen identified in the hazard analysis will achieve. If this information is not provided, establishments will need to conduct or provide additional research to show that either the target pathogen would behave similarly to the microorganisms studied in the scientific support, or that the intervention will function as intended.

In-plant support. The revised draft guidance explains that to conduct an adequate in-plant demonstration, establishments need to identify the critical operating parameters documented in the scientific support. The draft guidance stresses that the critical operating parameters often will be in addition to the critical limit associated with the critical control points. The document provides that establishments should implement all of the critical operating parameters identified in the scientific support.

The draft document has also been revised to remove references the use of in-plant microbiological testing as a necessary part of the in-plant demonstration component of the HACCP validation process. Instead, the revised guidance emphasizes the importance of achieving the scientifically supported critical operating parameters under in-plant conditions.

Identifying critical operating parameters. The revised draft guidance contains a new Appendix, “ Guidance to Identify Critical Operational Parameters from Supporting Documentation,” that explains how establishments can apply journal articles to their own processes and how to identify in the journal article the essential or critical operating parameters. FSIS will post information on its Web site on how to identify critical operating parameters documented in a journal article. This Web posting will include examples of journal articles that have been broken down to identify the critical operating parameters.

FSIS shared the revised draft HACCP validation guidance with the National Advisory Committee on Meat and Poultry Inspection (NACMPI) at the committee's public meeting held on September 22-23, 2011. The draft compliance guidance that the Agency is making available through this Federal Register document reflects recommendations made by the NACMPI HACCP Systems Validation Sub-Committee. Most of the revisions recommended by NACMPI were to improve the clarity of the document. For example, in response to a NACMPI recommendation, the draft compliance guidance now clearly and concisely describes the distinction between validation and verification and explains how the establishment's HACCP plan reassessment fits into the process. The draft guidance reiterates that the establishment is required to reassess its HACCP plan annually and whenever changes occur that affect the hazard analysis or HACCP plan (9 CFR 417.2(a)). The draft guidance also makes clear that that to conduct an effective reassessment, establishments should review the records generated by the entire HACCP system and analyze these records to determine how the HACCP system is performing as a whole. Pre-requisite programs are a critical part of the environment in which HACCP plans function and are therefore an important part of any HACCP plan reassessment. FSIS also updated the guidance to include guidance for validating cooking instructions for ground poultry patties.

The NACMPI report is available on the FSIS Web site at: http://www.fsis.usda.gov/PDF/Validation_Issue_Paper_Final.pdf .

In addition to comments on the draft guidance document, the NACMPI also made recommendations on FSIS's implementation and verification activities after the Agency issues final validation guidance. The NACMPI recommended that FSIS “phase in” its activities to ensure that establishments have appropriately validated HACCP systems by focusing first on those product categories that present the greatest public health risk. The NACMPI also recommended that at their next annual reassessment, existing establishments should be expected to have determined whether they need to collect additional in-plant data to complete their validation or whether the data they have collected meet the validation requirements. FSIS believes that both recommendations have merit and requests comments on them.

The revised draft guidance document is available for public viewing in the FSIS docket room and on the FSIS Web site at http://www.fsis.usda.gov/Regulations_&_Policies/Compliance_Assistance/index.asp . FSIS again invites comments on the revised guidance document, as well as on the issues discussed in this Federal Register document. The Agency will also hold a public meeting to discuss the revised draft guidance and to solicit additional input on validation requirements.

After considering the public input and comments it receives on the revised draft guidance document, FSIS will issue a final guidance document on HACCP system validation and publish a Federal Register document to announce its availability. At that time, FSIS will also announce when Agency personnel will begin to take enforcement actions if it finds that an establishment has failed to conduct and document in-plant validation.

Until then, FSIS inspection personnel will continue to issue a noncompliance record (NR) if an establishment lacks the required scientific or technical support for its HACCP system, or if the scientific or technical support is inadequate. FSIS will also continue to issue an NOIE if, taken together with other relevant findings, an establishment's scientific or technical support is inadequate, and the Agency can support a determination that the establishment's HACCP system is inadequate for any of the reasons provided in 9 CFR 417.6.

FSIS will also continue to conduct Food Safety Assessments (FSAs). If, when conducting an FSA, an EIAO finds that an establishment has not completed the in-plant demonstration, the EIAO will note this finding in the FSA and inform the establishment. Until the enforcement date, FSIS will not issue NRs or take enforcement actions based solely on a finding that an establishment lacks in-plant validation data.

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this document, FSIS will announce it online through the FSIS Web page located at http://www.fsis.usda.gov/regulations/2012_Notices_Index/. FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS' policies, procedures, regulations, Federal Register notices, public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. Through the Listserv and Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at http://www.fsis.usda.gov/news_and_events/email_subscription/. Information is available about a variety of topics including recalls, exports, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and they have the option to password protect their accounts.

Concurrently with the publication of this notice of proposed rulemaking, the Ex-Im Bank OIG is publishing a new system of records notice that is subject to the Privacy Act of 1974, 5 U.S.C. 552a. The system is entitled, “EIB-35-Office of Inspector General Investigative Records”. The system of records is necessary in order for Ex-Im Bank OIG to carry out its investigative responsibilities pursuant to the Inspector General Act of 1978, as amended.

Ex-Im Bank is proposing to exempt this system, in part, from certain provisions of the Privacy Act. The OIG is responsible for conducting and supervising independent and objective audits, inspections, and investigations of the programs and operations of Ex-Im Bank. The OIG promotes economy, efficiency, and effectiveness within the Ex-Im Bank and prevents and detects fraud, waste, and abuse in its programs and operations. The OIG's Office of Investigations investigates allegations of criminal, civil, and administrative misconduct involving Ex-Im Bank employees, contractors, programs and activities. These investigations can result in criminal prosecutions, fines, civil monetary penalties, and administrative sanctions.

The new system of records assists the OIG with receiving and processing allegations of violation of criminal, civil, and administrative laws and regulations relating to Ex-Im Bank employees, contractors, and other individuals and entities associated with Ex-Im Bank. The system includes both paper investigative files and the “Inspector General Information System” (IGIS), an electronic case management and tracking information system, which also generates reports. IGIS allows the OIG to manage information provided during the course of its investigations, and, in the process, to facilitate its management of investigations and investigative resources.

The Privacy Act embodies fair information principles in a statutory framework governing the means by which the United States Government collects, maintains, uses, and disseminates personally identifiable information. The Privacy Act applies to information that is maintained in a “system of records.” A “system of records” is a group of any records under the control of an agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. Individuals may request their own records that are maintained in a system of records in the possession or under the control of Ex-Im Bank by complying with Ex-Im Bank Privacy Act regulations, 12 CFR part 404.

The Privacy Act requires each agency to publish in the Federal Register a description of the type and character of each system of records that the agency maintains, and the routine uses that are contained in each system in order to make agency recordkeeping practices transparent, to notify individuals regarding the uses to which personally identifiable information is put, and to assist individuals in finding such files within the agency.

The Privacy Act allows government agencies to exempt certain records from the access and amendment provisions. If an agency claims an exemption, however, it must issue a Notice of Proposed Rulemaking to make clear to the public the reasons why a particular exemption is claimed.

Ex-Im Bank is claiming exemptions from certain requirements of the Privacy Act for the “EIB-35-Office of Inspector General Investigative Records” because information in this system of records relates to official law enforcement activities. These exemptions are needed to protect information relating to Ex-Im Bank OIG activities from disclosure to subjects of investigations and others related to these activities.

Specifically, the exemptions are required to preclude subjects of investigations from frustrating the investigative process; to avoid disclosure of investigative techniques; to protect the identities and physical safety of confidential informants and law enforcement personnel; to ensure Ex-Im Bank OIG's ability to obtain information from third parties and other sources; to protect the privacy of third parties; to fulfill commitments made to protect the confidentiality of sources; and to safeguard confidential information. Disclosure of information to the subject of the inquiry could also permit the subject to avoid detection or apprehension.

The exemptions proposed here are standard law enforcement exemptions exercised by a large number of Federal law enforcement and intelligence agencies. In appropriate circumstances, where compliance would not appear to interfere with or adversely affect the law enforcement purposes of this system and the overall law enforcement process, the applicable exemptions may be waived on a case by case basis.

For the reasons stated in the preamble, Ex-Im Bank proposes to amend chapter IV of Title 12, Code of Federal Regulations, as follows:

We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2012-0425; Directorate Identifier 2011-NM-273-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

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

We received multiple reports of cracks of overwing frames on Model MD-80 airplanes, and one report each on Model MD-90-30 and Model 717 airplanes. The Model 717 airplane had accumulated 18,235 total flight hours and 14,542 total flight cycles. Due to similarity in frame design, the manufacturer determined the overwing frames at stations 674, 696, and 715 on Model 717 airplanes are susceptible to cracks. The cracks, caused by fatigue, originate in the upper radius of the frame inboard tab just below the floor. This condition, if not corrected, could result in a severed frame, which may increase the loading of adjacent frames and result in damage to the adjacent structure and consequent loss of structural integrity of the airplane.

The overwing frames on Model 717 airplanes have the same design as those installed on Model MD-80 and Model MD-90-30 airplanes. AD 2008-13-29, Amendment 39-15592 (73 FR 38883, July 8, 2008), addresses cracked overwing frames on Model MD-80 airplanes. AD 2010-05-04, Amendment 39-16213 (75 FR 8465, February 25, 2010), addresses cracked overwing frames on Model MD-90-30 airplanes.

We reviewed Boeing Alert Service Bulletin 717-53A0034, dated October 5, 2011. That service bulletin describes procedures for repetitive general visual and high frequency eddy current inspections to detect cracking of the overwing frames at stations 674, 696, and 715, left and right sides, and related investigative and corrective actions if necessary.

Related investigative actions include measuring crack length. Corrective actions include a blend-out repair, or replacing the cracked overwing frame with a new frame, depending on the results of the inspection.

For the repetitive inspections for cracking of the overwing frames, the service information specifies an interval not to exceed 9,300 flight cycles; except after accomplishing a replacement, the next inspection is within 20,000 flight cycles after the replacement.

We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of these same type designs.

This proposed AD would require accomplishing the actions specified in the service information described previously.

We estimate that this proposed AD affects 129 airplanes of U.S. registry.

We estimate the following costs to comply with this proposed AD:

We estimate the following costs to do any necessary replacements/repairs that would be required based on the results of the proposed inspections. We have no way of determining the number of aircraft that might need these replacements:

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

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

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

For the reasons discussed above, I certify this proposed regulation:

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

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

(3) Will not affect intrastate aviation in Alaska, and

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

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

Comments Invited

We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.

We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

The European Aviation Safety Agency (EASA), which is the Technical Agent for Italy, a Member State of the European Union, issued EASA AD No. 2009-0137, dated June 23, 2009, for the Agusta Model A109E helicopter to correct an unsafe electrical condition caused by an inadequately functioning circuit breaker that was not within design requirements. That EASA AD required installing a “BATT BUS” circuit breaker modification kit on the Model A109E helicopters. Based on the unsafe condition created by this circuit breaker as described in EASA AD No. 2009-0137, the FAA issued AD 2010-20-21 (75 FR 61341, October 5, 2010; Correction published at 75 FR 65224, October 22, 2010) to require installing a “BATT BUS” circuit breaker modification kit on Model A109E helicopters in the United States. Subsequently, EASA issued AD No. 2009-0264, dated December 15, 2009, to correct the same unsafe condition on the Agusta Model A109S helicopters due to the design commonality between the electrical power distribution system of the Model A109E and A109S helicopters. The FAA is now proposing to issue this AD for the Model A109S helicopters to correct this same unsafe condition.

These helicopters have been approved by the aviation authority of Italy and are approved for operation in the United States. Pursuant to our bilateral agreement with Italy, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD.

We are proposing this AD because we evaluated all information provided by EASA and determined that an unsafe condition exists and is likely to exist or develop on other products of the same type design.

Agusta has issued Bollettino Tecnico No. 109S-35, dated December 11, 2009 (BT), which specifies modifying and testing the “BATT BUS” circuit breaker installation. The EASA classified this BT as mandatory and issued AD No. 2009-0264, dated December 15, 2009, to ensure the continued airworthiness of these helicopters.

This proposed AD would require compliance with specified portions of the manufacturer's service bulletin including modifying the electrical power distribution system by installing a “BATT BUS” Circuit Breaker Modification Kit, part number 109-0824-73-107, and thereafter, testing for proper functioning of the electrical system.

This proposed AD does not reference the calendar date of June 30, 2010, which has already passed.

We estimate that this proposed AD would affect 15 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. It would take about 8 work-hours per helicopter to install the `BATT BUS' circuit breaker modification kit at an average labor rate of $85 per work-hour and required parts would cost about $471 per helicopter. Based on these figures, we estimate the total cost impact of the proposed AD on U.S. operators to be $17,265.

According to the service information of the production approval holder (PAH), some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage by the PAH. Accordingly, we have included all costs in our cost estimate.

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

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

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

For the reasons discussed, I certify this proposed regulation:

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

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

3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and

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

We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

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

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA 2012-0121 and Airspace Docket No. 12-AAL-2) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2012-0121 and Airspace Docket No. 12-AAL-2”. The postcard will be date/time stamped and returned to the commenter.

All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E airspace extending upward from 700 feet above the surface at Scammon Bay Airport, Scammon Bay, AK. Controlled airspace is necessary to accommodate aircraft using the new RNAV (GPS) standard instrument approach procedures at Scammon Bay Airport, Scammon Bay, AK. This action would enhance the safety and management of aircraft operations at the airport.

Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify controlled airspace at Scammon Bay Airport, Scammon Bay, AK.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA 2012-0274 and Airspace Docket No. 12-ANM-4) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2012-0274 and Airspace Docket No. 12-ANM-4”. The postcard will be date/time stamped and returned to the commenter.

All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's Web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Roundup Airport, Roundup, MT, to accommodate aircraft using new RNAV (GPS) standard instrument approach procedures at Roundup Airport. This action would enhance the safety and management of aircraft operations at Roundup Airport, Roundup, MT.

Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at Roundup Airport, Roundup, MT.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Comments Invited

Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.

Communications should identify both docket numbers (FAA Docket No. FAA 2012-0322 and Airspace Docket No. 12-AAL-3) and be submitted in triplicate to the Docket Management System (see ADDRESSES section for address and phone number). You may also submit comments through the Internet at http://www.regulations.gov.

Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2012-0322 and Airspace Docket No. 12-AAL-3”. The postcard will be date/time stamped and returned to the commenter.

All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.

An electronic copy of this document may be downloaded through the Internet at http://www.regulations.gov. Recently published rulemaking documents can also be accessed through the FAA's web page at http://www.faa.gov/airports_airtraffic/air_traffic/publications/airspace_amendments/.

You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the ADDRESSES section for the address and phone number) between 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. An informal docket may also be examined during normal business hours at the Northwest Mountain Regional Office of the Federal Aviation Administration, Air Traffic Organization, Western Service Center, Operations Support Group, 1601 Lind Avenue SW., Renton, WA 98057.

Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.

The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface at Unalakleet Airport, Unalakleet, AK. Controlled airspace is necessary to accommodate aircraft using the new RNAV (GPS) standard instrument approach procedures at Unalakleet Airport, and would enhance the safety and management of instrument flight rules operations at the airport.

Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.9V, dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify controlled airspace at Unalakleet Airport, Unalakleet, AK.

This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.

Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:

On March 9, 2007 (Exchange Act Release No. 55431, 72 FR 12862 (Mar. 19, 2007)), the Commission requested comment on proposed amendments to the Commission's net capital, customer protection, books and records, and notification rules for broker-dealers under the Exchange Act. 1 Specifically, the proposed amendments are designed to address several areas of concern regarding the financial requirements for broker-dealers. They also would update the financial responsibility rules and make certain technical amendments.

The Commission originally requested that comments on this proposal be received by May 18, 2007, and subsequently extended the public comment period to June 18, 2007. 2 The Commission is reconsidering these proposals presently. Given economic events since the rule amendments were proposed, as well as regulatory developments, comments received on the proposed amendments, the continuing public interest in the proposed amendments and the passage of time, the Commission believes that it would be appropriate to facilitate additional public comments on the proposed rule amendments. Accordingly, the Commission is reopening the public comment period for 30 days.

The Office of Science and Technology Policy (OSTP) is proposing regulations to govern its implementation of the Freedom of Information Act (FOIA), 5 U.S.C. 552, as amended. FOIA requires Federal agencies, as defined by the Act, to make official documents and other records available to the public upon request, unless the material requested falls under one of several statutorily prescribed exemptions. FOIA also requires agencies to publish rules stating the time, place, fees, and procedures to apply in making records available pursuant to a proper request. Further, Section 1803 of the Freedom of Information Reform Act of 1986 requires each agency to establish a system for recovering costs associated with responding to requests for information under FOIA. The Office of Management and Budget (OMB) has issued guidelines that set standard government-wide definitions for assessing and collecting FOIA fees (OMB Fee Guidelines). These proposed rules describe the structure of OSTP's FOIA Requester Service Center, prescribe methods of requesting records, explain the manner in which OSTP responds to records requests, and describe policies governing applicable fees.

The proposed regulations also incorporate the policies expressed in President Obama's January 21, 2009, Executive Memorandum on the Freedom of Information Act, Attorney General Holder's March 19, 2009, Memorandum for Heads of Executive Departments and Agencies, and OSTP's FOIA Improvement Plan, issued in response to these directives. As required by the President's January 2009 Executive Memorandum, agencies, including those entities within the Executive Office of the President that are subject to FOIA, must adopt a presumption in favor of disclosure (except where disclosure creates a “foreseeable harm” as described in the Department of Justice, Office of Information Policy's April 17, 2009, Guidance) and ensure that their FOIA operations treat requesters courteously and appropriately. In addition, each agency is required to provide FOIA requesters and the public in general with “citizen-centered” ways to learn about both the agency's FOIA procedures and how to receive agency records that are publicly available.

By implementing the provisions of the January 21, 2009, Executive Memorandum and Attorney General Holder's March 19, 2009, Memorandum to the Heads of Executive Departments and Agencies, these regulations will improve FOIA-related service and performance, thereby strengthening OSTP's compliance with FOIA. Accordingly, OSTP proposes these regulations implementing FOIA and submits them for public comment pursuant to 5 U.S.C. 552(a)(4)(A), (a)(6)(B)(iv), (a)(6)(D), (a)(6)(E), and 5 U.S.C. 553.

These regulations have been drafted and reviewed in accordance with Executive Order 12866, Regulatory Planning and Review, Section 1(b), Principles of Regulation. These regulations are not a significant regulatory action under Section 3(f) of Executive Order 12866.

OSTP has determined that the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., does not apply because these regulations do not contain any information collection requirements subject to approval by OMB.

These regulations meet the applicable standards set forth in Executive Order 12988, Civil Justice Reform.

These regulations will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, OSTP has determined that these regulations do not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

OSTP, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 605(b), has reviewed these proposed regulations and certifies that they will not have a significant economic impact on a substantial number of small entities because they pertain to administrative matters affecting the agency.

These regulations will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1501, et seq.

These regulations are not major regulations as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 804. They will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

OSTP has reviewed this action for purposes of the National Environmental Policy Act of 1969 (NEPA), 42 U.S.C. 4321-4347, and has determined that this action will not have a significant effect on the human environment.

Therefore, according to reasons stated in the preamble, the Office of Science and Technology Policy proposes to add 32 CFR part 2402 to read as follows:

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2012-0227), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov ) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Proposed Rule” and insert “USCG-2012-0227” in the “Keyword” box. Click “Search” then click on the balloon shape in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2012-0227” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one using one of the four methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

For information on facilities or services for individuals with disabilities or to request special assistance at the public meeting, contact LCDR Chris O'Neal at the telephone number or email address indicated under the FOR FURTHER INFORMATION CONTACT section of this notice.

On July 1, 2012 Cavalier Golf & Yacht Club will host a fireworks display on the shoreline of the navigable waters on Broad Bay in Virginia Beach, VA. The fireworks will be launched from a shore based platform centered on position 36°52′08″ N/076°00′46″ W (NAD 1983). Due to the need to protect mariners and spectators from the hazards associated with the fireworks display, such as the accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris, vessel traffic will be temporarily restricted on all navigable waters within 400 yard radius of the fireworks launch site.

The Captain of the Port Hampton Roads proposes to change the enforcement period of the safety zone for one recurring fireworks event within the Fifth Coast Guard District. This regulation applies to the July 4th fireworks event listed at (c)(4), in the Table to Sec. 165.506. The event will not be taking place on July 4th.

The Table to Sec. 165.506, event (c)(4), establishes the enforcement date for the fireworks event held in Virginia Beach, VA, on specified waters of the Broad Bay within the area bounded by 400 yard radius centered on position 36°52′08″ N/076°00′46″ W (NAD 1983). The area of the safety zone enforcement will not change; the date of enforcement of the safety zone will change. This temporary safety zone will be enforced in the vicinity of Virginia Beach, VA from 9:30 p.m. to 10 p.m. on July 1, 2012. In the interest of public safety, general navigation within the safety zone will be restricted during the specified date and times. Except for participants and vessels authorized by the Coast Guard Captain of the Port or his representative, no person or vessel may enter or remain in the regulated area.

We developed this proposed 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 proposed 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. Although this proposed regulation restricts access to the safety zone, the effect of this rule will not be significant because: (i) The safety zone will be in effect for a limited duration; (ii) the zone is of limited size; and (iii) the Coast Guard will make notifications via maritime advisories so mariners can adjust their plans accordingly.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed 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 proposed rule would not have a significant economic impact on a substantial number of small entities because the zone will only be in place for a limited duration and maritime advisories will be issued allowing the mariners to adjust their plans accordingly.

This proposed rule would affect the following entities, some of which might be small entities: the owners and operators of vessels intending to transit or anchor in that portion of the Broad Bay from 9:30 p.m. until 10 p.m. on July 1, 2012. This safety zone would not have a significant economic impact on a substantial number of small entities for the following reasons. This safety zone would be activated, and thus subject to enforcement, for only one-half hour in the evening, when vessel traffic is low. Although the safety zone would apply to the entirety of Broad Bay, traffic would be allowed to pass through the zone with the permission of the Captain of the Port Before the activation of the zone, we would issue maritime advisories widely available to users of the river.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact LCDR Hector Cintron, Waterways Management Division Chief, Sector Hampton Roads, Coast Guard; telephone 757-668-5581, email Hector.L.Cintron@uscg.mil. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

This proposed rule would call 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 proposed rule under that Order and have determined that it does not have implications for federalism.

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

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

This proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.

We have analyzed this proposed 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 made a preliminary determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. In accordance with the Coastal Zone Management Act, National Environmental Policy Act, and the Endangered Species Act an environmental consultation has been initiated with Virginia Department of Environmental Quality, Army Corps of Engineers, Virginia Marine Resource Commission, and The Department of Conservation and Recreation. Upon receipt of consultation comments all documentation will be made available in the docket where indicated under ADDRESSES . This proposed rule involves establishing a temporary safety zone. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

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

We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to http://www.regulations.gov and will include any personal information you have provided.

If you submit a comment, please include the docket number for this rulemaking (USCG-2012-0251), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online (via http://www.regulations.gov ) or by fax, mail, or hand delivery, but please use only one of these means. If you submit a comment online via www.regulations.gov, it will be considered received by the Coast Guard when you successfully transmit the comment. If you fax, hand deliver, or mail your comment, it will be considered as having been received by the Coast Guard when it is received at the Docket Management Facility. We recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go to http://www.regulations.gov, click on the “submit a comment” box and insert “USCG-2012-0251” in the “Keyword” box. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8 1/2 by 11 inches, suitable for copying and electronic filing. If you submit comments by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period and may change the rule based on your comments.

To view comments, as well as documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2012-0251” and click “Search.” You may also visit the Docket Management Facility in Room W12-140 on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc. ). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the Federal Register (73 FR 3316).

We do not now plan to hold a public meeting. But you may submit a request for one using one of the four methods specified under ADDRESSES . Please explain why you believe a public meeting would be beneficial. If we determine that one would aid this rulemaking, we will hold one at a time and place announced by a later notice in the Federal Register .

Fireworks display events are frequently held on or adjacent to navigable waters within the boundary of the Fifth Coast Guard District. For a description of the geographical area of each Coast Guard Sector—Captain of the Port Zone, please see 33 CFR 3.25.

This regulation proposes to temporarily change the enforcement period and regulated area for a safety zone for two annually recurring fireworks events, described at (b)(5) and (b)(21) of the Table to 33 CFR 165.506, that are normally scheduled to occur each year on June 14th and June and July—Saturday or Sunday before Independence Day holiday, respectively.

On June 16, 2012, the American Flag Foundation will sponsor their annual fireworks event. This event will take place in Baltimore, MD on the waters of the Patapsco River. The regulation at 33 CFR 165.506 is enforced annually for this event. Also, a fleet of spectator vessels is expected to gather near the event site to view the fireworks.

On July 3, 2012, the Tred Avon Yacht Club will sponsor their annual fireworks event. This event will take place in Oxford, MD on the waters of the Tred Avon River. The regulation at 33 CFR 165.506 is enforced annually for this event. Also, a fleet of spectator vessels is expected to gather near the event site to view the fireworks.

The Coast Guard proposes to temporarily change the enforcement period and geographic regulated area of the safety zone for two recurring fireworks events within the Fifth Coast Guard District. This regulation applies to the June 14th fireworks event listed at (b)(5) and the June and July—Saturday or Sunday before Independence Day holiday fireworks event listed at (b)(21), both in the Table to Sec. 165.506.

The Table to Sec. 165.506, event (b)(5), establishes the enforcement date and regulated area for the American Flag Foundation fireworks event held in Baltimore, MD. This regulation also temporarily changes the regulated area for the fireworks event. The position is changed to latitude 39°15′54″ N, longitude 076°34′40″ W (NAD 1983) and the distance is change to a 200-yard radius. The temporary safety zone will be enforced from 8 p.m. to 10:30 p.m. on June 16, 2012, and will restrict general navigation in the regulated area during the event. The American Flag Foundation, which is the sponsor for this event, holds this event annually. Except for participants and vessels authorized by the Coast Guard Captain of the Port Baltimore or the designated on-scene patrol personnel, no person or vessel will be allowed to enter or remain in the regulated area. This regulation is needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

The Table to Sec. 165.506, event (b)(21), establishes the enforcement date and regulated area for the Tred Avon Yacht Club fireworks event held in Oxford, MD. This regulation temporarily changes the regulated area for the fireworks event. The position is changed to latitude 38°41′24″ N, longitude 076°10′37″ W (NAD 1983). The temporary safety zone will be enforced from 8 p.m. to 10:30 p.m. on July 3, 2012, and will restrict general navigation in the regulated area during the event. The Tred Avon Yacht Club, which is the sponsor for this event, holds this event annually. Except for participants and vessels authorized by the Coast Guard Captain of the Port Baltimore or the designated on-scene patrol personnel, no person or vessel will be allowed to enter or remain in the regulated area. This regulation is needed to control vessel traffic during the event to enhance the safety of participants, spectators and transiting vessels.

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 proposed 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 would restrict access to these areas, the effect of this proposed rule will not be significant because: (i) The safety zones will only be in effect from 8 p.m. to 10:30 p.m. on June 16, 2012 and July 3, 2012, (ii) the Coast Guard will give advance notification via maritime advisories so mariners can adjust their plans accordingly, and (iii) although the safety zone will apply to the sections of the Patapsco River, Northwest Harbor (East Channel), and the Tred Avon River, vessel traffic will be able to transit safely around the safety zone.

Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have considered whether this proposed 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 proposed rule would not have a significant economic impact on a substantial number of small entities. This proposed rule will affect the following entities, some of which may be small entities: the owners or operators of vessels intending to operate, transit, or anchor in the specified portions of the Patapsco River, Northwest Harbor (East Channel), from 8 p.m. through 10:30 p.m. on June 16, 2012, and the Tred Avon River, from 8 p.m. through 10:30 p.m. on July 3, 2012. This proposed safety zone will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) The regulated areas are of limited size, (ii) this proposed rule will only be in effect for five hours total, and (iii) although the safety zone will apply to a section of the Patapsco River and Tred Avon River, vessel traffic will be able to transit safely around the safety zone. Before the enforcement period, the Coast Guard will issue maritime advisories widely available to users of the waterway, to allow mariners to make alternative plans for transiting the affected area.

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

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule so that they can better evaluate its effects on them and participate in the rulemaking. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact Mr. Ronald Houck, Sector Baltimore Waterways Management Division, Coast Guard; telephone 410-576-2674, email Ronald.L.Houck@uscg.mil. The Coast Guard will not retaliate against small entities that question or complain about this proposed rule or any policy or action of the Coast Guard.

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

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

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

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

We have analyzed this proposed 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 made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. A preliminary environmental analysis checklist supporting this determination is available in the docket where indicated under ADDRESSES . This proposed rule involves implementation of regulations at 33 CFR part 165 that establish safety zones on navigable waters of the United States for fireworks events. These safety zones are enforced for the duration of fireworks display events. The fireworks are launched from or immediately adjacent to navigable waters of the United States and may have potential for negative impact on the safety or other interest of waterway users and near shore activities in the event area. The category of activities includes fireworks launched from barges at or near the shoreline that generally rely on the use of navigable waters as a safety buffer.

This proposed rule is categorically excluded, under figure 2-1, paragraph (34)(g), of this instruction. This rule establishes a temporary safety zone to protect the public from fireworks fallouts and premature detonations. We seek any comments or information that may lead to the discovery of a significant environmental impact from this proposed rule.

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

In two submissions dated April 16, 2012, New York State Department of Environmental Conservation submitted two SIP revision requests. The first SIP revision requests that EPA include in New York's Regional Haze SIP the New York State legislation regulating the sulfur content of fuel oil, Bill Number S1145C, which amends the New York Environmental Conservation Law to include a new section 19-0325.

The second SIP revision requests that EPA take action on proposed SIP revisions from New York in parallel with the State's processing of the following draft Title V permits that the State intends to submit as SIP revisions to meet the BART requirement: Bowline Point Generating Station, Danskammer Generating Station, Kodak Operations at Eastman Business Park, Oswego Harbor Power Owens Corning Delmar Plant, and Syracuse Energy Corporation.

New York also requested processing of the following adopted Title V permits implementing BART for the following facilities: 59th Street Station [Con Ed], ALCOA Massena Operations (West Plant), Arthur Kill Generating Station [NRG], EF Barrett Power Station (NG), Holcim (US) Inc-Catskill Plant, International Paper Ticonderoga Mill, Lafarge Building Materials, Lehigh Northeast Cement Northport Power Station (NG), Ravenswood Generating Station [TC], Ravenswood Steam Plant [Con Edison], Roseton Generating Station [Dynegy], and Samuel A Carlson Generating Station [Jamestown Board of Public Utilities (BPU)].

These materials have been placed in the docket for our proposed action on the New York regional haze SIP submission, Docket ID No. EPA-R02-OAR-2012-0296.

EPA was aware that New York State intended to submit additional information relevant to the action EPA was proposing on New York's Regional Haze SIP. EPA, therefore, discussed in its proposal the possible actions EPA would take should this information be timely submitted. EPA included in the record the draft information that New York was in the process of finalizing and submitting as part of its SIP revision. EPA evaluated this draft information as part of the Agency's proposed action on New York's Regional Haze SIP.

EPA is notifying interested parties that EPA's final action will be based on the proposed rulemaking, the additional information identified in this notice of data availability, and an assessment of any public comments that may be received.

Portions of this SIP revision are being proposed under a procedure called parallel processing, whereby EPA proposes rulemaking action concurrently with the state's procedures for amending its regulations. If the proposed revision is substantially changed in areas other than those identified in the proposal, EPA will evaluate those changes and may publish another notice of proposed rulemaking. If no substantial changes are made other than those areas cited in the proposal, EPA will publish a final rulemaking on the revisions.

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When submitting comments, remember to:

i. Identify the document by docket ID number and other identifying information (subject heading, Federal Register date and page number).

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

iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.

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

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

vi. Provide specific examples to illustrate your concerns and suggest alternatives.

vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.

viii. Make sure to submit your comments by the comment period deadline identified.

This proposed rule provides a comment period of 60 days for any person to state an interest in retaining a tolerance or tolerance exemption proposed for revocation. If EPA receives a comment within the 60-day period to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(f), if needed. The order would specify data needed and the timeframes for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FFDCA.

EPA issues a final rule after considering comments that are submitted in response to this proposed rule. In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings.

EPA is proposing to revoke certain tolerances and to promulgate other tolerances with expiration dates, for the fungicide ziram, the herbicides butylate, clethodim, isopropyl carbanilate, methanearsonic acid, and primisulfuron-methyl; the insecticides dichlorvos, dicofol, methomyl, naled, and tralomethrin, and tolerance exemptions for the pesticides rotenone, derris, cube roots, and pine oil.

Section 321 of FFDCA defines a pesticide residue as including metabolites and degradates of the pesticide. Therefore, EPA is proposing to make minor revisions to the tolerance expressions for dicofol, methanearsonic acid, methomyl, and tralomethrin, in accordance with current Agency practice to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances. The revisions to the tolerance expressions do not substantively change the tolerance or, in any way, modify the permissible level of residues permitted by the tolerance.

In addition, EPA is proposing to revise the nomenclature of specific tolerances for butylate, methomyl, and tralomethrin, and remove expired tolerances for arsanilic acid, cyhexatin, ethion, fenthion, fonofos, lindane, orthoarsenic acid, phosphamidon, and triazamate. In addition, EPA is proposing to reinstate popcorn tolerances for metolachlor.

EPA is proposing to revoke certain tolerances because they are no longer needed or are associated with food uses that are no longer registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The proposed revocations for dichlorvos, naled, and pine oil are consistent with the recommendations in the dichlorvos, naled, and pine oil Reregistration Eligibility Decisions (REDs) of 2006. As part of the tolerance reassessment process, EPA is required to determine whether each of the amended tolerances meets the safety standard of FFDCA. The safety finding determination of “reasonable certainty of no harm” is discussed in detail in each RED. REDs recommend the implementation of certain tolerance actions, including modifications to reflect current use patterns, meet safety findings, and change commodity names and groupings in accordance with new EPA policy. Printed copies of many REDs may be obtained from EPA's National Service Center for Environmental Publications (EPA/NSCEP), P.O. Box 42419, Cincinnati, OH 45242-2419; telephone number: 1-800-490-9198; fax number: 1-513-489-8695; Internet at http://www.epa.gov/ncepihom and from the National Technical Information Service (NTIS), 5285 Port Royal Rd., Springfield, VA 22161; telephone number: 1-800-553-6847 or (703) 605-6000; Internet at http://www.ntis.gov. Electronic copies are available on the Internet for the dichlorvos, naled, and pine oil REDs at http://www.epa.gov/pesticides/reregistration/status.htm.

In REDs, Chapter IV on risk management, reregistration, and tolerance reassessment typically describes the regulatory position, cumulative safety determination, determination of safety for U.S. general population, and safety for infants and children. In particular, the human health risk assessment document which supports the RED describes risk exposure estimates and whether the Agency has concerns. EPA also seeks to harmonize tolerances with international standards set by the Codex Alimentarius Commission, as described in Unit III.

It is EPA's general practice to propose revocation of those tolerances for residues of pesticide active ingredients on crop uses for which there are no active registrations under FIFRA, unless any person in comments on the proposal indicates a need for the tolerance to cover residues in or on imported commodities or legally treated domestic commodities.

Certain tolerances pertaining to the pesticides subject to this proposal have expired due to previous EPA regulation setting expiration dates. Therefore, EPA is proposing to remove the expired tolerances from the Code of Federal Regulations. This rule only corrects the Code of Federal Regulations to conform with the fact that the tolerances already expired, and therefore EPA is not accepting comments regarding the expiration itself.

1. Arsanilic acid. Because the sole tolerance for the plant growth regulator arsanilic acid expired on February 28, 2001, EPA is proposing to remove it from 40 CFR 180.550, and remove that section in its entirety.

2. Butylate. In the Federal Register notice of July 28, 2010 (75 FR 44240) (FRL-8835-2), EPA published a notice of cancellation of pesticides for non-payment of year 2010 registration maintenance fees, which included the announcement of cancellations for both an end-use product registration and last technical chemical registration for butylate. The cancellation orders permitted the registrant to sell and distribute existing stocks of affected products until January 15, 2011, one year after the date on which the fee was due. Persons other than registrant are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products. In the Federal Register notice of January 26, 2011 (76 FR 4692) (FRL-8856-9), EPA published a notice of receipt of voluntary requests by registrants to cancel certain pesticide registrations, including an end-use registration for butylate, the last butylate product registered for use in the United States. In the Federal Register notice of March 23, 2011 (76 FR 16417) (FRL-8867-8), EPA issued a cancellation order which granted the requested cancellation for the last butylate registration and permitted the registrant to sell and distribute existing stocks of the affected product containing butylate for 1 year after the date of publication of the cancellation order in the Federal Register ; i.e., until March 23, 2012. Persons other than registrant are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products.

EPA believes that existing stocks are likely to be exhausted by March 23, 2013. Therefore, EPA is proposing to revoke the tolerances for butylate in 40 CFR 180.232(a) on corn, field, forage; corn, field, grain; corn, field, stover; corn, pop, forage; corn, pop, grain; corn, sweet, forage; and corn, sweet, kernel plus cob with husks removed; each with an expiration/revocation date of March 23, 2013.

Also, in order to conform to current Agency practice, EPA is proposing in 40 CFR 180.232(a) to revise the commodity terminology for “corn, pop, forage” to “corn, pop, stover.”

3. Clethodim. The commodity “soybean soapstock” is no longer considered by the Agency to be a significant animal feed item and therefore the tolerance is no longer needed. Consequently, EPA is proposing to revoke the tolerance in 40 CFR 180.458(a) on soybean, soapstock.

4. Cyhexatin. Because the sole tolerance for the insecticide cyhexatin expired on June 13, 2009, EPA is proposing to remove it from 40 CFR 180.144, and remove that section in its entirety.

5. Dichlorvos. On February 5, 1998 (63 FR 5907) (FRL-5743-9), EPA published a proposed rule in the Federal Register concerning a number of pesticide active ingredients and proposed tolerance actions, including the proposed revocation of the tomato tolerance for dichlorvos in 40 CFR 180.235 because there were no active registrations for use of dichlorvos on tomatoes in the United States, and therefore the tolerance was no longer needed. However, during the public comment period and as described in the final rule published in the Federal Register on October 26, 1998 (63 FR 57067) (FRL-6035-6), EPA received comment from the Canadian Horticultural Council (CHC). Consequently, EPA did not revoke the dichlorvos tolerance on tomato at that time. The CHC stated that revocation of the tomato tolerance would create a barrier to Canadian exports and requested that tolerances be maintained until pesticide alternatives were available to producers in Canada. EPA believes that there is no longer a need for the dichlorvos tolerance on tomato. Possible alternative insecticides such as fenpropathrin, deltamethrin, chlorantraniliprole, spinetoram, spinosad, permethrin, acetamiprid, imidacloprid, and lambda-cyhalothrin have both Canadian MRLs and U.S. tolerances on tomato or vegetable, fruiting, group 8, where a U.S. tolerance is at or exceeds the level of the corresponding Canadian MRL for the pesticide. Therefore, EPA is proposing to revoke the dichlorvos tolerance in 40 CFR 180.235(a)(1) on tomato, postharvest (residues expressed as naled).

6. Dicofol. As a result of on an agreement in principle signed by the EPA and the technical registrants of dicofol on May 17, 2011, registrants requested voluntary product cancellation and amendment. The cancellations included the last products containing dicofol registered for use in the United States. Dicofol registrants agreed to cease all production of dicofol as of May 17, 2011, cease all sales and distribution of dicofol end-use products by October 31, 2013, and amend end-use products to add a condition of registration that as of August 31, 2011, registrants will not sell or distribute dicofol end-use products that do not bear a prominent sticker prior to sale or distribution by the dicifol registrants that declares: “It is unlawful to use this product after October 31, 2016.”

In the Federal Register of June 22, 2011 (76 FR 36535) (FRL-8875-7), EPA announced its receipt of the requests from registrants to voluntarily cancel the last product registrations for use of dicofol in the United States. In the Federal Register of December 14, 2011 (76 FR 77824) (FRL-9326-5), EPA published a cancellation order in follow-up to the June 22, 2011 Notice of Receipt of Requests. The cancellation order allowed registrants of dicofol end-use products to sell and distribute existing stocks until October 31, 2013, persons other than the registrants to sell and distribute existing stocks until December 31, 2013, and use of existing stocks of any of the dicofol end-use products until October 31, 2016. Therefore, EPA is proposing to revoke the dicofol tolerances in 40 CFR 180.163(a)(1) on apple, wet pomace; bean, dry, seed; bean, succulent; butternut; caneberry subgroup 13A; chestnut; citrus, dried pulp; citrus oil; cotton, refined oil; cotton, undelinted seed; fruit, citrus, group 10; fruit, pome, group 11; fruit, stone, group 12; grape; grape, raisin; hazelnut; hop, dried cones; nut, hickory; nut, macadamia; pecan; peppermint, oil; peppermint, tops; spearmint, oil; spearmint, tops; strawberry; tea, dried; tea, plucked leaves; vegetable, cucurbit, group 9; vegetable, fruiting, group 8; and walnut; each with an expiration/revocation date of October 31, 2016.

Also, EPA is proposing to revoke the dicofol tolerances in 40 CFR 180.163(a)(2) on cattle, fat; cattle, liver; cattle, meat; cattle, meat byproducts, except liver; egg; goat, fat; goat, liver; goat, meat; goat, meat byproducts, except liver; hog, fat; hog, liver; hog, meat; hog, meat byproducts, except liver; horse, fat; horse, liver; horse, meat; horse, meat byproducts, except liver; milk, fat (reflecting 0.75 ppm in whole milk); poultry, fat; poultry, meat; poultry, meat byproducts; sheep, fat; sheep, liver; sheep, meat; and sheep, meat byproducts, except liver; each with an expiration/revocation date of October 31, 2016.

In addition, EPA is proposing to revise the section heading in 40 CFR 180.163 from “1,1-bis(4-chlorophenyl)-2,2,2-trichloroethanol” to “dicofol.” Also, in order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expressions for dicofol in 40 CFR 180.163(a)(1) and (a)(2) to read as set out in the proposed regulatory text at the end of this document.

7. Ethion. Because all the tolerances for the insecticide ethion expired on October 1, 2008, EPA is proposing to remove them from 40 CFR 180.173, and remove that section in its entirety.

8. Fenthion. Because all the tolerances for the insecticide fenthion expired, some on April 1, 2006 and some on April 1, 2003, EPA is proposing to remove them from 40 CFR 180.214, and remove that section in its entirety.

9. Fonofos. Because all the tolerances for the insecticide O -ethyl S -phenyl ethylphosphonodithioate, also known as fonofos, expired on December 31, 2002, EPA is proposing to remove them from 40 CFR 180.221, and remove that section in its entirety.

10. Isopropyl carbanilate. Because there have been no active registrations in the United States for isopropyl carbanilate (also called propham) since 1991, the interim tolerances are no longer needed and therefore should be revoked. Therefore, EPA is proposing to revoke the interim tolerances for isopropyl carbanilate in 40 CFR 180.319 on alfalfa, hay; clover, hay; grass, hay; alfalfa, forage; clover, forage; grass, forage; flax, seed; lentil; lettuce, head; lettuce, leaf; pea; safflower, seed; spinach; beet, sugar, roots; beet, sugar, tops; egg; cattle, fat; cattle, meat; cattle, meat byproducts; goat, fat; goat, meat; goat, meat byproducts; hog, fat; hog, meat; hog, meat byproducts; horse, fat; horse, meat; horse, meat byproducts; milk; sheep, fat; sheep, meat; sheep, meat byproducts; poultry, fat; poultry, meat; and poultry, meat byproducts.

11. Lindane. Because all the tolerances for the insecticide lindane expired on October 2, 2009, EPA is proposing to remove them from 40 CFR 180.133, and remove that section in its entirety.

12. Methanearsonic acid. As a result of an agreement in principle signed by the EPA and the technical registrants of the organic arsenicals on January 16 and February 5, 2009, registrants requested voluntary product cancellation and amendment. Some of the cancellations included the last products containing disodium methanearsonate (DSMA) registered for use in the United States, and cancellation and amendment of products for monosodium methanearsonate (MSMA) which would terminate its citrus, bearing and non-bearing, uses. In the Federal Register of July 8, 2009 (74 FR 32596) (FRL-8422-6), EPA announced its receipt of the requests and provided a public comment period. In the Federal Register of September 30, 2009 (74 FR 50187) (FRL-8437-7), EPA published a cancellation order in follow-up to the July 8, 2009, Notice of Receipt of Requests. The cancellation order prohibited registrants from selling or distributing existing stocks (with citrus uses) after December 31, 2009, and persons other than the registrants from selling or distributing existing stocks after December 31, 2010, but allowed their use until exhaustion. EPA believes that existing stocks (with citrus use) will be exhausted 2 years after December 31, 2010; i.e., by December 31, 2012. Therefore, EPA is proposing to revoke the tolerance in 40 CFR 180.289(a) for methanearsonic acid, from application of DSMA and MSMA, in or on fruit, citrus with an expiration/revocation date of December 31, 2012.

Also, in order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expression for methanearsonic acid in 40 CFR 180.289(a) to read as set out in the proposed regulatory text at the end of this document.

13. Methomyl. In the Federal Register notice of October 24, 2007 (72 FR 60364) (FRL-8153-3), EPA published a notice of receipt of voluntary requests for amendments by registrants to delete the grape use in methomyl registrations. In the Federal Register notice of December 8, 2010 (75 FR 76456) (FRL-8855-6), EPA issued a cancellation order granting the requested amendments to terminate use and permitted the registrant to sell and distribute existing stocks of the affected products containing methomyl for 18 months after the date of the cancellation order; i.e., until June 8, 2012. Persons other than the registrant are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products.

EPA believes that existing stocks will be exhausted by June 8, 2013. Therefore, EPA is proposing to revoke the tolerance for methomyl in 40 CFR 180.253(a) on grape with an expiration/revocation date of June 8, 2013.

In order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expressions for methomyl in 40 CFR 180.253(a) and (c) to read as set out in the proposed regulatory text at the end of this document.

Also, in order to conform to current Agency practice, EPA is proposing in 40 CFR 180.253(a) to revise the commodity terminology for “cucurbits” to “vegetable, cucurbit, group 9;” “orange, sweet” to “orange;” “pepper” to “pepper, bell” and “pepper, nonbell;” “sorghum, forage” to “sorghum, grain, forage;” “sorghum, grain” to “sorghum, grain, grain;” “soybean” to “soybean, seed;” “vegetable, fruiting” to “vegetable, fruiting, group 8;” and “vegetable, root” to “vegetable, root and tuber, group 1;” and to remove the “(N)” designation, which means negligible residues, wherever it appears in 40 CFR 180.253(a).

14. Metolachlor. In the Federal Register of September 17, 2008 (73 FR 53732) (FRL-8375-2), EPA finalized tolerance actions for specific active ingredients including metolachlor, for which the Agency completed a number of actions, including decreasing tolerance levels in 40 CFR 180.368(a)(1) on corn fodder and forage to 6.0 parts per million (ppm) and revising the commodity terminology of the tolerances on corn, grain to corn, field, grain; and corn, fodder to corn, field, stover and corn, sweet, stover. However, the Agency inadvertently omitted corn, pop, grain (previously covered by corn, grain) and corn, pop, stover (previously covered by corn, fodder) as part of the commodity terminology revisions for metolachlor in the final rule. Nor did the Agency include the popcorn tolerances for metolachlor in the Federal Register of August 8, 2007 (72 FR 44439) (FRL-8138-8) for the proposed rule. To remedy this inadvertent error and to cover existing popcorn registrations for metolachlor, the Agency proposes to correct the revisions and reinstate the tolerances in 40 CFR 180.368(a)(1) for corn, pop, grain at 0.10 ppm and corn, pop, stover at 6.0 ppm.

15. Naled. On February 5, 1998 (63 FR 5907)(FRL-5743-9), EPA published a proposed rule in the Federal Register concerning a number of pesticide active ingredients and proposed tolerance actions, including the proposed revocation of the lettuce tolerance for naled in 40 CFR 180.215 because there were no active registrations for use of naled on lettuce in the United States, and therefore the tolerance was no longer needed. However, during the public comment period and as described in the final rule published in the Federal Register on October 26, 1998 (63 FR 57067) (FRL-6035-6), EPA received comment from Valent USA Corporation, on behalf of Amvac Chemical Corporation, and the Canadian Horticultural Council (CHC). Consequently, EPA did not revoke the naled tolerance on lettuce at that time. Amvac requested that the lettuce tolerance be retained for import purposes and that it would support that import tolerance. However, recently, Amvac notified the Agency that it was no longer interested in supporting the lettuce tolerance for import purposes. The CHC stated that revocation of the lettuce tolerance would create a barrier to Canadian exports and requested that tolerances be maintained until pesticide alternatives were available to producers in Canada. EPA believes that there is no longer a need for the naled tolerance on lettuce. Possible alternative insecticides such as chlorantraniliprole, spinetoram, spinosad, permethrin, acetamiprid, imidacloprid, lambda-cyhalothrin, tebufenozide, and thiamethoxam have both Canadian MRLs and U.S. tolerances on lettuce, crop subgroup 4A (including lettuce), or vegetable, leafy, except brassica, group 4, where a U.S. tolerance is at or exceeds the level of the corresponding Canadian MRL for the pesticide. Therefore, EPA is proposing to revoke the naled tolerance in 40 CFR 180.215(a)(1) on lettuce.

16. Orthoarsenic acid. Because the sole tolerance for the defoliant orthoarsenic acid expired on July 1, 1995, EPA is proposing to remove it from 40 CFR 180.180, and remove that section in its entirety.

17. Phosphamidon. Because the sole tolerance for the insecticide phosphamidon expired on December 31, 2002, EPA is proposing to remove it from 40 CFR 180.239, and remove that section in its entirety.

18. Pine oil. Because there have been no active registrations in the United States for more than 10 years regarding the use of pine oil in honey and honeycomb, the exemption from the requirement of a tolerance for pine oil (also known as 1-methyl-4-isopropyl-1-cyclo-hexen-8-ol) residues in or on honey and honeycomb, when present as a result of its use as a deodorant at no more than 12 percent in formulation with the bee repellent butanoic anhydride applied in an absorbent pad over the hive, is no longer needed and therefore should be revoked. The revocation of the tolerance exemption is consistent with the recommendation in the pine oil RED of 2006. Consequently, EPA is proposing to revoke the tolerance exemption for pine oil in 40 CFR 180.1035 on honey and honeycomb.

19. Primisulfuron-methyl. Because there have been no active registrations for use of primisulfuron-methyl on sweet corn for more than 10 years and, for at least 10 years, active registrations have shown a label prohibition of its use on sweet corn, the tolerances on sweet corn are no longer needed. Therefore, EPA is proposing to revoke the tolerances in 40 CFR 180.452 on corn, sweet, forage and corn, sweet, stover.

20. Rotenone. In the Federal Register of July 28, 2010 (75 FR 44256) (FRL-8831-7), February 3, 2010 (75 FR 5643) (FRL-8807-6) and January 26, 2010 (75 FR 4072) (FRL-8808-2), EPA announced its receipt of requests for voluntary cancellation of certain pesticide registrations, including ones for rotenone (and other associated cube root resins) with agricultural uses, and provided public comment periods. In the Federal Register of March 23, 2011 (76 FR 16415) (FRL-8865-9), August 11, 2010 (75 FR 48669) (FRL-8839-9) and May 11, 2010 (75 FR 26227) (FRL-8822-4), EPA published cancellation orders in follow-up to the July 28, 2010, January 26, 2010 and February 3, 2010 Notice of Receipt of Requests, respectively. The cancellation order of March 23, 2010 allowed registrants to sell and distribute existing stocks until May 2011 and persons other than the registrants to sell, distribute, or use existing stocks until May 2011. The cancellation order of August 11, 2010 allowed registrants to sell and distribute existing stocks until August 11, 2011 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. The cancellation order of May 11, 2010 allowed registrants to sell and distribute existing stocks until May 11, 2011 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. EPA believes that existing stocks will be exhausted by August 11, 2012. Therefore, in 40 CFR 180.905, EPA is proposing to redesignate existing paragraph (b) as new paragraph (c) and recodify the tolerance exemptions for rotenone or derris or cube roots from existing paragraph (a) into newly designated paragraph (b) with expiration/revocation dates of August 11, 2012.

21. Tralomethrin. In the Federal Register of May 4, 2011 (76 FR 25334) (FRL-8870-5), November 17, 2010 (75 FR 70256) (FRL-8850-1), and November 10, 2010 (75 FR 69073) (FRL-8851-5), EPA announced its receipt of requests for voluntary cancellation of certain pesticide registrations, including ones for tralomethrin associated with agricultural and food/feed handling establishment uses, and provided public comment periods. In the Federal Register of July 8, 2011 (76 FR 40359) (FRL-8878-7) and February 25, 2011 (76 FR 10587) (FRL-8863-4), EPA published cancellation orders in follow-up to the May 4, 2011, and the November 17, 2010 and November 10, 2010 Notice of Receipt of Requests, respectively. The cancellation order of February 25, 2011 allowed registrants to sell and distribute existing stocks until February 25, 2012 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. The cancellation order of July 8, 2011 allowed registrants to sell and distribute existing stocks until July 9, 2012 and persons other than the registrants to sell, distribute, or use existing stocks until exhaustion. EPA believes that existing stocks will be exhausted by July 9, 2013. Therefore, EPA is proposing to revoke tralomethrin tolerances in 40 CFR 180.422(a)(1) on broccoli; cotton, undelinted seed; cotton, oil; lettuce, head; lettuce, leaf; soybean; and sunflower, seed; each with an expiration/revocation date of July 9, 2013. Also, in order to conform to current Agency practice, EPA is proposing in 40 CFR 180.422(a)(1) to revise the commodity terminology for “soybean” to read “soybean, seed.”

Also, EPA is proposing to revoke the tralomethrin tolerance in 40 CFR 180.422(a)(2) on food commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food-handling establishments at 0.02 ppm with an expiration/revocation date of July 9, 2013.

In addition, EPA is proposing to revoke the tralomethrin tolerance in 40 CFR 180.422(a)(3) on feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in feed-handling establishments at 0.02 ppm with an expiration/revocation date of July 9, 2013.

In order to describe more clearly the measurement of residues for tolerances and coverage of metabolites and degradates of a pesticide by the tolerances, EPA is proposing to revise the tolerance expressions for tralomethrin in 40 CFR 180.422(a)(1), (a)(2), and (a)(3) to read as set out in the proposed regulatory text at the end of this document.

22. Triazamate. Because the sole tolerance for triazamate expired on December 31, 2001, EPA is proposing to remove it from 40 CFR 180.536, and remove that section in its entirety.

23. Ziram. In the Federal Register notice of December 1, 2010 (75 FR 74714) (FRL-8854-3), EPA published a notice of receipt of voluntary requests for amendments by registrants to delete certain uses, including the last blackberry uses in ziram registrations. In the Federal Register notice of May 11, 2011 (76 FR 27317) (FRL-8871-2), EPA issued a cancellation order, which included granting the requested amendments to terminate the last ziram registrations for blackberry use and permitted the registrant to sell and distribute existing stocks of the affected products containing ziram for 12 months after the date of the cancellation order; i.e., until May 11, 2012. Persons other than the registrants are permitted to sell, distribute, and/or use existing stocks of products whose labels include the deleted uses until supplies are exhausted, provided that the use complies with the EPA approved label and labeling of the affected products.

EPA believes that existing stocks are likely to be exhausted by May 11, 2013. Therefore, EPA is proposing to revoke the tolerance for ziram in 40 CFR 180.116(a) on blackberry with an expiration/revocation date of May 11, 2013.

A “tolerance” represents the maximum level for residues of pesticide chemicals legally allowed in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a, as amended by FQPA of 1996, Public Law 104-170, authorizes the establishment of tolerances, exemptions from tolerance requirements, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore “adulterated” under FFDCA section 402(a), 21 U.S.C. 342(a). Such food may not be distributed in interstate commerce (21 U.S.C. 331(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under FIFRA (7 U.S.C. 136 et seq. ). Food-use pesticides not registered in the United States must have tolerances in order for commodities treated with those pesticides to be imported into the United States.

EPA's general practice is to propose revocation of tolerances for residues of pesticide active ingredients on crops for which FIFRA registrations no longer exist and on which the pesticide may therefore no longer be used in the United States. EPA has historically been concerned that retention of tolerances that are not necessary to cover residues in or on legally treated foods may encourage misuse of pesticides within the United States. Nonetheless, EPA will establish and maintain tolerances even when corresponding domestic uses are canceled if the tolerances, which EPA refers to as “import tolerances,” are necessary to allow importation into the United States of food containing such pesticide residues. However, where there are no imported commodities that require these import tolerances, the Agency believes it is appropriate to revoke tolerances for unregistered pesticides in order to prevent potential misuse.

Furthermore, as a general matter, the Agency believes that retention of import tolerances not needed to cover any imported food may result in unnecessary restriction on trade of pesticides and foods. Under FFDCA section 408, a tolerance may only be established or maintained if EPA determines that the tolerance is safe based on a number of factors, including an assessment of the aggregate exposure to the pesticide and an assessment of the cumulative effects of such pesticide and other substances that have a common mechanism of toxicity. In doing so, EPA must consider potential contributions to such exposure from all tolerances. If the cumulative risk is such that the tolerances in aggregate are not safe, then every one of these tolerances is potentially vulnerable to revocation. Furthermore, if unneeded tolerances are included in the aggregate and cumulative risk assessments, the estimated exposure to the pesticide would be inflated. Consequently, it may be more difficult for others to obtain needed tolerances or to register needed new uses. To avoid potential trade restrictions, the Agency is proposing to revoke tolerances for residues on crops for which FIFRA registrations no longer exist, unless someone expresses a need for such tolerances. Through this proposed rule, the Agency is inviting individuals who need these import tolerances to identify themselves and the tolerances that are needed to cover imported commodities.

Parties interested in retention of the tolerances should be aware that additional data may be needed to support retention. These parties should be aware that, under FFDCA section 408(f), if the Agency determines that additional information is reasonably required to support the continuation of a tolerance, EPA may require that parties interested in maintaining the tolerances provide the necessary information. If the requisite information is not submitted, EPA may issue an order revoking the tolerance at issue.

EPA proposes that these regulations become effective on the date of publication of the final rule in the Federal Register . With the exception of certain tolerances for butylate, dicofol, methanearsonic acid (and salts), methomyl, tralomethrin, and ziram, and tolerance exemptions for rotenone, derris, and cube roots for which EPA is proposing specific expiration/revocation dates, the Agency is proposing that these tolerance revocations and reinstatements, and revisions of tolerance nomenclatures and tolerance expressions become final on the date of publication of the final rule in the Federal Register . With the exception of the specific tolerances for which EPA is proposing expiration/revocation dates, the Agency believes that existing stocks of pesticide products labeled for the uses associated with the tolerances proposed for revocation have been completely exhausted and that treated commodities have cleared the channels of trade. EPA is proposing an expiration/revocation date of March 23, 2013 for all of the tolerances for butylate, October 31, 2016 for all of the tolerances for dicofol, December 31, 2012 for the methanearsonic acid tolerance on fruit, citrus, June 8, 2013 for the methomyl tolerance on grape, July 9, 2013 for all of the tolerances for tralomethrin, May 11, 2013 for the ziram tolerance on blackberry, and August 11, 2012 for the tolerance exemptions for rotenone (or derris or cube roots). The Agency believes that these revocation dates allow users to exhaust stocks and allows sufficient time for passage of treated commodities through the channels of trade. However, if EPA is presented with information that existing stocks would still be available and that information is verified, the Agency will consider extending the expiration date of the tolerance. If you have comments regarding existing stocks and whether the effective date allows sufficient time for treated commodities to clear the channels of trade, please submit comments as described under SUPPLEMENTARY INFORMATION .

Any commodities listed in this proposal treated with the pesticides subject to this proposal, and in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this unit, any residues of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of the Food and Drug Administration that:

1. The residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and

2. The residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates when the pesticide was applied to such food.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL for butylate, isopropyl carbanilate (also called propham), methanearsonic acid (and salts), metolachlor, naled, pine oil, primisulfuron-methyl, rotenone (or derris or cube roots), tralomethrin, clethodim in or on soybean soapstock, or for dichlorvos on tomato.

The Codex has not established a MRL for ziram per se, but has MRLs for total dithiocarbamates (which includes the dithiocarbamate ziram), determined as carbon disulfide. However, there is no MRL for total dithiocarbamates in or on blackberry.

The Codex has established a MRL for methomyl in or on grapes at 5 milligrams/kilogram (mg/kg). This MRL is the same as the tolerance established for methomyl on grapes in the United States.

The Codex has established MRLs for dicofol in or on cattle meat at 3 mg/kg, eggs at 0.05 mg/kg, poultry meat and cottonseed at 0.1 mg/kg, and cherries at 5 mg/kg. These MRLs and some others are the same as the tolerances established for dicofol in the United States.

The Codex has established MRLs for dicofol in or on various other commodities, including beans, dry at 0.1 mg/kg, citrus fruits at 5 mg/kg, hops, dry at 50 mg/kg, melons, except watermelon at 0.2 mg/kg, pecans and walnuts at 0.01 mg/kg, and peppers, summer squash, and tomato at 1 mg/kg. These MRLs are all covered by U.S. tolerances at higher levels. These MRLs are different than the tolerances established for dicofol in the United States because of differences in use patterns and/or good agricultural practices.

In this proposed rule, EPA is proposing to revoke specific tolerances established under FFDCA section 408. The Office of Management and Budget (OMB) has exempted this type of action (e.g., tolerance revocation for which extraordinary circumstances do not exist) from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this proposed rule has been exempted from review under Executive Order 12866 due to its lack of significance, this proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). This proposed rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any special considerations as required by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994); or OMB review or any other Agency action under Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency previously assessed whether revocations of tolerances might significantly impact a substantial number of small entities and concluded that, as a general matter, these actions do not impose a significant economic impact on a substantial number of small entities. This analysis was published on December 17, 1997 (62 FR 66020) (FRL-5753-1), and was provided to the Chief Counsel for Advocacy of the Small Business Administration. Taking into account this analysis, and available information concerning the pesticides listed in this proposed rule, the Agency hereby certifies that this proposed rule will not have a significant negative economic impact on a substantial number of small entities. In a memorandum dated May 25, 2001, EPA determined that eight conditions must all be satisfied in order for an import tolerance or tolerance exemption revocation to adversely affect a significant number of small entity importers, and that there is a negligible joint probability of all eight conditions holding simultaneously with respect to any particular revocation. (This Agency document is available in the docket of this proposed rule). Furthermore, for the pesticides named in this proposed rule, the Agency knows of no extraordinary circumstances that exist as to the present proposal that would change the EPA's previous analysis. Any comments about the Agency's determination should be submitted to the EPA along with comments on the proposal, and will be addressed prior to issuing a final rule. In addition, the Agency has determined that this action will not have a substantial direct effect on 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, entitled “Federalism” (64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” This proposed rule directly regulates growers, food processors, food handlers, and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). For these same reasons, the Agency has determined that this proposed rule does not have any “tribal implications” as described in Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.” This proposed rule will not have substantial direct effects on tribal governments, 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 in Executive Order 13175. Thus, Executive Order 13175 does not apply to this proposed rule.

Therefore, it is proposed that 40 CFR chapter I be amended as follows:

Background

On April 13, 2012, we proposed revisions to the regulations governing permits for take of golden eagles (Aquila chrysaetos) and bald eagles (Haliaeetus leucocephalus), where the take is associated with, but not the purpose of, an activity (see 77 FR 22267, April 13, 2012). We proposed to extend the maximum term for a programmatic permit from 5 to 30 years, if the permit incorporates conditions requiring implementation of additional measures to ensure the preservation of eagles, if needed. This change would facilitate the responsible development of renewable energy and other projects that will be in operation for many decades while being consistent with statutory mandates protecting eagles.

The proposed rule would amend the schedule of permit fees set forth at 50 CFR 13.11 to substantially increase the fees charged for processing programmatic permit applications for such long-term permits. The permit application processing fee is proposed to be $36,000. In addition, the regulations propose an “administration fee” based on the duration of the permits to recover our costs for monitoring and working with the permittees over the lives of the permits. The proposed administration fee ranges from $2,600 for permits with tenures of 5 years or less to $15,600 for 30-year permits. The regulations propose a reduced application processing fee of $5,000 for permit applications for small wind projects and other activities not expected to have significant effects on eagles.

The proposed rule also contains provisions that would allow permits to be transferred from one party to another and to clarify that programmatic permits issued under the Bald and Golden Eagle Protection Act (16 U.S.C. 668-668d) to Federal, State, tribal, or local governmental entities provide take authorization for persons acting under the jurisdiction of the permitted government agency under certain circumstances.

We are now extending the public comment period for the proposed rule to allow interested members of the public an additional opportunity to provide input. The comment period will close on July 12, 2012. If you have already submitted comments on the April 13, 2012, proposed rule, please do not resubmit them. We will fully consider all comments we receive when preparing a final determination on the proposed rule.

For more information about the proposed regulatory changes, please see the April 13, 2012, proposed rule, available on http://www.regulations.gov at Docket No. FWS-R9-MB-2011-0054 and on our Web site at: http://www.fws.gov/migratorybirds/BaldAndGoldenEagleManagement.htm.

You may submit your comments and supporting materials by one of the methods listed in ADDRESSES . We request that you submit comments by only one method. We will not consider comments sent by email or fax, or written comments sent to an address other than the one listed in ADDRESSES . If you submit a comment via http://www.regulations.gov, your entire comment—including any personal identifying information—will be posted on the Web site. If you submit a hardcopy comment that includes personal identifying information, you may request that we withhold this information from public review, but we cannot guarantee that we will be able to do so. We will post all hardcopy comments on http://www.regulations.gov.

Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection at http://www.regulations.gov, or by appointment, during normal business hours, by contacting the person listed above under FOR FURTHER INFORMATION CONTACT .

The Monkfish FMP is jointly managed by the Councils. The Councils have managed the fishery since 1999 primarily through the allocation of days-at-sea (DAS) and establishment of trip limits for both the directed (DAS) and incidental fisheries. While scientific evidence for stock structure remains equivocal, the fishery has been managed as two stocks divided by a boundary that bisects Georges Bank. Since 2007, both stock components have been determined by stock assessments to be rebuilt (above their respective biomass targets) and not subject to overfishing.

On November 30, 2010, the Councils published a Notice of Intent to prepare an amendment (Amendment 6) to the FMP to consider modifications to the management program that may include one of several catch shares management alternatives, including sectors or Limited Access Privilege Programs (LAPPs). Sectors are voluntary, self-selected groups of fishermen that are allocated a portion of the available catch. Sector management has already been adopted in the Northeast Multispecies FMP, and a substantial number of vessels that have limited access permits in the monkfish fishery also participate in groundfish sectors. LAPPs are a category of management approaches that provides a person or entity (for example, a community) the exclusive privilege to harvest a specific portion of a fishery's total allowable catch. LAPPs can include individual fishery quotas (IFQs) or community development quotas. Section 303A of the Magnuson-Stevens Act specified general requirements for LAPPs, including the requirement that such programs be approved in a referendum of eligible participants (as defined by the Councils) for New England fisheries.

The Councils are considering catch shares management in the monkfish fishery to address some operational considerations for vessels that participate in the monkfish fishery and also are members of groundfish sectors. NOAA's 2010 Catch Share Policy promotes catch shares management and encourages Councils to consider such programs, where appropriate, to achieve the conservation, social, and economic goals of sustainable fishery management.

Because some elements of catch share programs involve allocation of privileges based on historical performance in the fishery, including, in the case of LAPPs, eligibility to participate in the required referendum, on February 2 and February 16, 2012, the Councils requested that NMFS publish this ANPR announcing a control date in the monkfish fishery, in part to discourage speculative activity, including, but not limited to, increasing landings history, accumulation of fishing permits, or participation in the fishery solely for the purpose of qualifying to vote in the referendum.

The date of publication of this notification, May 9, 2012, shall be known as the “control date” for the monkfish fishery and may be used as a reference date for future management measures in determining how to treat fishing privileges or landings history acquired before this date and those acquired after this date, depending on the Councils' determinations on limiting control and ownership of such privileges and landings. The establishment of a control date, however, does not obligate the Councils to use this control date or take any action, nor does it prevent the Councils from picking another control date or imposing limits on permits acquired prior to the control date.

Accordingly, this notification is intended to promote awareness that the Councils may be developing management measures to address these concerns, to provide notice to the public that any current or future accumulation of fishing privilege interests in the monkfish fishery may be affected, restricted, or even nullified, and discourage speculative behavior in the market for fishing privileges while the Councils consider whether and how such limitations on accumulation of fishing privileges should be developed. Any measures the Councils are considering may require changes to the Monkfish FMP. Such measures may be adopted in a future amendment to the FMP, which would include opportunity for further public participation and comment.

If the Councils decide to propose a LAPP for the monkfish fishery, this control date may be used in determining eligibility for referendum voters. The Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) section 303A(c)(6)(D) requires that any IFQ program developed by the New England Fishery Management Council must be approved by a referendum. NMFS published guidelines for conducting a referendum on December 15, 2008 (73 FR 75968), that detailed the procedures for (1) determining procedures and voting eligibility requirements for IFQ program referenda, and (2) conducting such referenda in a fair and equitable manner. A referendum conducted on a proposed IFQ program in New England must be approved by more than 2/3 of those voting in the referendum among eligible permit holders and other eligible voters. Other eligible voters may include crew members who derive a significant portion of their income from the monkfish fishery.

This notification also gives the public notice that interested participants should locate and preserve records that substantiate and verify their ownership or control of monkfish permits and other fishing privileges in the monkfish fishery, as well as monkfish landings in Federal waters. Fishing privileges include, but are not limited to, vessels, fishing permits, DAS, and any other type of catch share.

This notification and control date do not impose any legal obligations, requirements, or expectation.