On January 16, 2009, President George W. Bush signed Executive Order 13488. Section 5 of the order states that “[i]ndividuals in positions of public trust shall be subject to reinvestigation under standards (including but not limited to the frequency of such reinvestigation) as determined by the Director of the Office of Personnel Management, to ensure their suitability for continuing employment.” Section 2 of the order defines the terms “Position of Public Trust” and “Suitability” by reference to 5 CFR part 731. Section 6(b) delegates to OPM the “authority to implement this order, including the authority to issue regulations and guidance governing suitability, or guidance related to fitness, as the Director determines appropriate.” Finally, section 6(a) states that “[a]n agency shall report to the Office of Personnel Management the nature and results of the background investigation and fitness determination (or later changes to that determination) made on an individual, to the extent consistent with law.”

E.O. 13488 is distinct from, but complementary to, E.O. 13467, which concerns, among other things, alignment, to the extent possible, of investigations and standards relating to suitability or fitness, eligibility for logical and physical access, eligibility to hold a sensitive position, eligibility for access to classified information, and, as appropriate, contractor employee fitness.

Public trust positions are those covered by 5 CFR part 731 that an agency head, under 5 CFR 731.106, has designated at a moderate or high risk level, based on the position's potential for adverse impact on the efficiency or integrity of the service. These positions may involve policy-making, major program responsibility, public safety and health, law enforcement duties, fiduciary responsibilities, or other duties demanding a significant degree of public trust, or access to or operation or control of financial records, with a significant risk for causing damage or realizing personal gain. Agencies designate public trust positions, and their risk levels, following OPM guidance and taking into account the specific duties of each position.

On November 3, 2009, OPM published, in the Federal Register at 74 FR 56747, a proposed rule to guide agencies in carrying out the new requirement to reinvestigate individuals in public trust positions under E.O. 13488. The public comment period ended on January 4, 2010. Several Federal Agency commenters indicated they were unable to provide an informed recommendation related to the frequency of reinvestigations without specific information regarding the scope of the reinvestigations. Thus, on November 5, 2010, OPM published a notice in the Federal Register at 75 FR 68222 reopening the comment period on the proposed rule. This notice provided additional information about the scope of reinvestigations for public trust positions to allow for further comment about reinvestigation frequency. In addition, OPM proposed revising the text of the proposed rule at 5 CFR 731.106(d)(2), to resolve an ambiguity regarding investigations that satisfy the public trust reinvestigation requirement, and solicited additional public comment on the revised text. The comment period on this second Federal Register notice ended on December 6, 2010.

In response to the original proposed rule and the reopener, OPM received comments from 8 agencies, 4 unions, and 5 individuals. OPM carefully considered comments received in response to the November 3, 2009, and November 5, 2010, Federal Register notices in the development of this final rule. The comments fell into one of the following categories: frequency of reinvestigations; impact on resources; timing of implementation of the reinvestigation cycle; reinvestigation requirements; alignment of reinvestigation standards; confusion regarding the term “assessment”; insufficiency of the information provided; breaks in service of less than 24 months; collective bargaining and labor relations; and miscellaneous. We have not addressed the remaining comments either because they concerned other suitability subparts not being revised or did not relate to suitability at all.

Many commenters voiced concerns about the frequency of public trust reinvestigations. One labor organization representative said OPM should withdraw the proposed rule and reissue it after providing the rationale for the reinvestigation, the number of Federal employees affected, the reinvestigation criteria, and a cost estimate for performing such investigations. Another labor organization commented that OPM should reconsider the need for periodic reinvestigations in the first place and, upon reexamination, recommend to the Administration that the Executive Order be rescinded. Other commenters stated that OPM should not issue a reinvestigation cycle requirement without first analyzing the actual need for, and effectiveness of, these investigations, their overall costs to the Government, and whether research exists that suggests 5 years is the most appropriate timeframe. A commenter recommended that reinvestigations be conducted every 10 or 15 years, and opined that it does not appear appropriate to require the same reinvestigation timeframes for public trust positions as for national security positions, considering the potential for harm to the United States. Another commenter recommended a frequency of 10 years, as OPM has not provided data to demonstrate that a more frequent reinvestigation cycle for public trust positions than for national security positions promotes the efficiency of the service. One commenter suggested the frequency be every 7 years as a cost-saving measure. Still another commenter recommended agencies be given additional flexibility so periodic background checks can be extended beyond a 5-year time limit or agencies be granted the flexibility to identify, based on their needs and knowledge of the positions, which ones require reinvestigations every 5 years, rather than imposing a blanket requirement for all positions. During the first comment period, one commenter stated that those positions that truly warrant periodic reinvestigations, such as supervisory and auditor positions, should be reinvestigated no more frequently than once every 5 years. However, during the second comment period, this same commenter stated those positions should be subject to periodic reinvestigations without mentioning a specific timeframe. A labor organization representative stated that, in making certain assumptions about the scope of the investigation, a frequency of every 10 years is sufficient. On the other hand, two commenters suggested that the time period for reinvestigations be lowered from 5 years to a frequency of every 2 or 3 years. Lastly, two commenters stated the policy change is appropriate considering the risk posed by public trust positions in their agency.

OPM did not adopt any of these recommendations. This rule is intended to satisfy E.O. 13488, which requires reinvestigations of public trust positions with a frequency as determined by the Director of the Office of Personnel Management. As described in the reopener, the investigative product for reinvestigations of employees occupying nonsensitive public trust positions will be the National Agency Check with Local Agency Check and Credit Check (NACLC) or Periodic Reinvestigation (PRI) depending on the level of public trust. As proposed, reinvestigations must occur frequently enough to ensure that continued employment of persons in public trust positions remains appropriate. The E.O. requires a meaningful determination of continuing suitability for employment. To be meaningful, a determination cannot reasonably be made with outdated information. Accordingly, we have decided to retain the 5-year reinvestigation requirement.

OPM chose the 5-year timeframe because it is consistent with the coverage period that has long been established as the minimum coverage period for suitability investigations. The National Agency Check with Written Inquiries (NACI) is the minimum required level of initial investigation and is required for low-risk positions. The coverage period for the NACI is 5 years and has historically been 5 years. Considering that a public trust position's potential adverse impact on the efficiency or integrity of the service is greater than that of low-risk positions, we believe 5 years is a reasonable timeframe for public trust reinvestigations. Further, if the scope of coverage for the original suitability investigation is 5 years, it follows that the reinvestigations should be completed within the same timeframe, at a minimum. Therefore, a less-frequent timeframe for reinvestigations has not been adopted.

E.O. 13467 requires OPM to consider efficiency and cost effectiveness in setting reinvestigative requirements as well. Regarding comments about the number of employees impacted and the costs associated with reinvestigations, we recognize that the number of employees who may be affected has a direct correlation to the cost of reinvestigations. However, it is difficult to arrive at an accurate number affected because of the evolving needs of agencies. Historical costs are, therefore, poor indicators of future costs. Agencies are responsible for assessing the position designations within their agencies and will know the number of employees to be reinvestigated and may, therefore, predict the cost based on the price of the required investigation. However, while we cannot allow too much time to go by between reinvestigations, we recognize the need to balance risk and cost. Therefore, we have chosen relatively low-cost investigative products, the NACLC and the PRI, to minimize the cost. As described below, we have also sought to reduce cost by aligning public trust and national security reinvestigation requirements. In addition, OPM commits to periodically assess the cost-effectiveness of the investigative products selected.

Commenters suggested that the frequency of public trust reinvestigations should be aligned with those required for clearance holders. We recognize the need for alignment to the extent possible. Therefore, in section 731.106(d)(2) of the final rule, as in the proposed rule, a reinvestigation for eligibility for access to classified information or to occupy a sensitive national security position may be sufficient to meet the requirements for a public trust reinvestigation. Likewise, in our proposed rule amending 5 CFR part 732, dated December 14, 2010, Designation of National Security Positions, the timeframe for reinvestigations is also set at 5 years for national security positions not requiring eligibility for access to classified information. We expect to publish the revised part 732 regulations in early 2012. In tandem, these provisions in parts 731 and 732 will ensure that one reinvestigation at least every 5 years will be sufficient to meet national security and public trust requirements, so that agencies will not have to bear the burden and expense of requesting multiple reinvestigations to meet separate requirements. A reinvestigation on a Special Sensitive or Critical Sensitive national security position will be sufficient to meet, the reinvestigation need of a High Risk public trust position. A reinvestigation on a Non-Critical Sensitive national security position will be sufficient to meet the reinvestigation need of a Moderate Risk public trust position.

A commenter suggested a 15-year timeframe is an appropriate frequency for reinvestigations for low-risk positions that are investigated with the National Agency Check with Inquiry Investigations (NACI's). However, this rule does not cover low-risk positions. It fulfills the requirements of E.O. 13488, which mandates that individuals who are in public trust positions, defined by 5 CFR part 731 as those designated as moderate and high risk, be reinvestigated. There is no government-wide requirement to conduct reinvestigations of employees in low-risk, nonsensitive positions.

During the initial comment period, a commenter suggested that OPM consider allowing additional flexibility following the first 5-year reinvestigation. The commenter suggested widening the window for subsequent reinvestigations to every 5-10 years at the discretion of the agency, depending on the nature of the position and its public trust level. During the second comment period, the same commenter suggested agencies be given discretion to stretch the reinvestigation period to 10 years. We did not adopt these recommendations. E.O. 13488 requires reinvestigations of individuals in public trust positions with a frequency determined by the Director of OPM, not by individual agencies. OPM has decided to require all agencies to follow the same reinvestigation schedule to promote consistency across the Federal Government. Further, 5 CFR 731.104 and 731.202 require reciprocal acceptance of prior suitability investigations and adjudications. A consistent reinvestigation cycle will promote reciprocity by giving gaining agencies confidence that they are accepting prior investigations and adjudications that were recent enough to have identified any serious issues that would have affected eligibility for continued employment.

A labor organization representative stated that longer intervals are needed between reinvestigations because it is a stressful and time-consuming process for the typical employee. However, reinvestigations must occur frequently enough if agencies are to carry out the purpose of Executive Order 13488 to ensure that continued employment of persons in public trust positions remains appropriate.

A commenter stated that clarification may be needed to ensure agencies understand the reinvestigation requirement is based on the completion date of the prior investigation. We agree and will provide clarification in the implementing guidance.

Many commenters made observations regarding the impact of reinvestigations on time, personnel, and financial resources. A commenter stated that large agencies with a high number of public trust positions would incur a heavy economic impact, while another commenter voiced concerns regarding the strain on personnel resources when taking on the additional reinvestigation requirements, since most employees in moderate-risk positions have not been reinvestigated. A commenter also voiced concern about OPM's Federal Investigative Services having the capacity to perform reinvestigations in a timely manner, while another commenter stated OPM will have major increases in costs and workload. Further, a labor organization representative commented that, since OPM does not know how many Federal employees will be subject to the regulation, no analysis of the program's cost has been provided. A labor organization representative further stated that, before the regulation can be properly evaluated, the costs must be examined. Another labor organization representative stated that OPM should postpone issuing the regulation until the number of employees affected by this regulation and the scope of the investigations that will be conducted are known. However, agencies also commented that such reinvestigations are necessary, and one commenter felt it was irrelevant to consider future investigation and resource capacities in the implementation of suitability policies and procedures.

OPM has not made changes to the rule as a result of these comments. While we agree that reinvestigations will take time and resources to accomplish, they are essential investments to ensure that continued employment of employees is appropriate. OPM's responses to comments about the cost and resource implications of the frequency of reinvestigations, the population affected, and the reinvestigation products selected, are addressed in greater detail above. OPM provides investigative services on a reimbursable basis, pursuant to a revolving fund established by Congress for this purpose, and is thus in a position to readily ensure that sufficient investigative resources are dedicated to meet the requirements of this rule.

During the first comment period, a commenter questioned whether the proposed regulation will allow effective and efficient use of time and resources if the regulations do not establish substantive regulatory standards for adjudicating public trust reinvestigations, and if agencies are unable to use suitability actions as the result of a reinvestigation. During the reopener, the commenter again voiced concerns that the proposed regulation does not meet the test of effectiveness and efficiency regarding the use of time and resources. The regulation is intended to satisfy E.O. 13488 which requires reinvestigations of public trust positions.

Because the Executive order requires a reinvestigation of “suitability for continuing employment” and defines “suitability” by reference to 5 CFR part 731, agencies should consider the substantive standards in § 731. 202, when evaluating the results of a public trust reinvestigation. However, a person's employment status will determine the applicable agency authority and procedures to be followed in any action taken based on the results of the reinvestigation. In most situations the subject of a reinvestigation will have been employed by his or her agency for more than 1 year following an appointment subject to investigation, and, in that context, only OPM could take a suitability action under 5 CFR part 731 and only under the limited circumstances described in § 731.105(d). Nonetheless, conduct that surfaces during a reinvestigation could form the basis for an adverse action under 5 CFR part 752. Whether to propose and take an adverse action on the basis of a public trust reinvestigation is a matter within the employing agency's discretion.

A commenter expressed concern that, given finite resources, security clearance cases are given first priority to ensure they meet the requirements of the law ( i.e., the timeliness requirements for security clearance adjudications in 50 U.S.C. 435b(g)). Further, the commenter stated that, with the implementation of the reinvestigation cycle for public trust positions, the timeliness of determinations based on public trust reinvestigations will only diminish unless Congress or the President requires them to be made within a specified timeframe. These comments did not make any specific recommendation as to the text of the rule. Accordingly, we did not make changes to the rule as a result of these comments. We note that E.O. 13488 requires individuals to be investigated with a frequency determined by the Director of OPM to ensure suitability for continued employment; and that to help achieve this objective the order requires agencies to report the results of background investigations to OPM. Section 731.206 of the final rule implements this reporting requirement, so that OPM can assess the timeliness of agency decisions. This regulation complements the reporting requirements in part 732 for national security investigations and adjudications, which also facilitate monitoring.

One commenter noted that the same resources used to meet new reinvestigation requirements are also used to make initial determinations for suitability and security for new hires. This commenter expressed concern about having sufficient resources to meet these requirements and suggested that the requirements will have an adverse impact on agencies' ability to meet the goals of OPM's Hiring Reform Initiative. As noted above, the re-investigation requirement was imposed by a 2009 Executive Order that requires reinvestigation of public trust positions. Therefore, we do not agree with this commenter's assessment of the impact on hiring reform. The hiring reform initiative is a comprehensive and integrated approach to Federal hiring that addresses workforce planning, recruitment, hiring process, security and suitability, and orientation. Moreover, this initiative assumes there are ongoing reform efforts to align investigative and adjudicative processes and also addresses various challenges throughout the hiring process, including limited resources. Agencies have known about the reinvestigation requirement for some time, now, and can be presumed to have anticipated its implementation.

A commenter inquired as to whether or not the proposed rule would create other changes to the investigation structure, the overall investigation process, or the types of investigations available that will ultimately impact agencies' workload. The final rule will not affect the structure of investigations, the process, or the types of investigation. However, OPM is assessing its investigative products as part of a Joint Security and Suitability Process Reform effort under E.O. 13467. Future Federal investigative standards resulting from this effort will use automated records to the extent possible and may impact the investigative structure and process. Other impacts on the investigative process may result from our proposed rule in 5 CFR part 732, dated December 14, 2010, Designation of National Security Positions, which prescribes time frames for national security reinvestigations.

One commenter indicated the regulation lacks clarity as to when the 5-year investigation period will begin following the rule's implementation, while other commenters suggested agencies be given flexibility to implement the reinvestigation cycle. OPM concurs and has added language to the rule stating that implementing guidance will be issued regarding time lines for implementing this regulation. Agencies will be afforded flexibility within the parameters set in that guidance.

One commenter suggested that the reinvestigation cycle be delayed until the new SF-85P, Questionnaire for Public Trust Positions, is published for agency use. This comment is beyond the scope of this regulation. This regulation is intended to satisfy E.O. 13488, which requires reinvestigations of public trust positions.

A commenter suggested delaying implementation of the reinvestigation cycle until OPM implements the tiered investigative model described in section 2.1(a) of E.O. 13467, where each successively higher level of investigation shall build upon, but not duplicate, the ones below it. We did not adopt this recommendation. Although OPM is working on the investigative standards contemplated by E.O. 13467, we do not believe the possibility of future changes to investigative products should affect the need to timely implement E.O. 13488. OPM has added language to this regulation at § 731.106(d)(1) stating that implementing guidance will be issued.

A labor organization representative expressed concern that this regulation will take effect without any prior notice to current Federal employees that informs them they may be subject to reinvestigations. This labor union representative also recommended that current employees be grandfathered under the old rules and the new rules apply only to future employees. This recommendation is not adopted as it does not satisfy the requirements of E.O. 13488, to conduct reinvestigations for all public trust positions. However, we do recognize the commenter's concern and have made revisions to the regulation at § 731.106(d)(3), requiring agencies to notify all current employees impacted by this rule of these new reinvestigation requirements.

The labor organization representative further commented that reinvestigations could result in employees being jeopardized for previously undisclosed past misconduct. OPM does not regard this as an effective argument against a reinvestigation requirement for public trust positions. Rather, the possibility that an employee may not always disclose past misconduct to the employing agency provides a sound reason for conducting such reinvestigations.

One commenter stated that the proposed language confuses reinvestigation requirements for national security positions with new reinvestigation requirements for public trust positions mandated by E.O. 13488. We disagree and did not make a change as a result of this comment. Rather, the separate authorities for reinvestigations for national security positions and public trust positions are outlined to ensure agencies avoid duplicate investigations where an existing investigation already satisfies the requirement.

In the Notice of Proposed Rulemaking dated November 3, 2009, the proposed language in § 731.106(d)(2) states: “If, prior to the next required reinvestigation, a separate investigation (or reevaluation) is conducted to determine a person's eligibility (or continued eligibility) for access to classified information or as a result of a change in risk level as provided in § 731.106(e), and that investigation is conducted at an equal or higher level than is required for a public trust reinvestigation, a new reinvestigation is not required. * * *” A commenter stated that the meaning of “at an equal or higher level” in § 731.106(d)(2) is unclear. We have reworded this paragraph to clarify that a new investigation is not needed if the previous investigation “meets or exceeds” the criteria required for a public trust reinvestigation.

A labor organization representative stated that it welcomed an indication that OPM intends the scope of reinvestigation for moderate-risk positions to be generally less intrusive and narrower in scope than the reinvestigation of employees in high-risk positions. It should be noted that the scope of the reinvestigation may be changed to meet needs such as a further assessment of character or conduct because of new information. A commenter suggested the use of automated reinvestigative database checks without a new investigative questionnaire. This suggestion is not feasible because the effectiveness of reinvestigations relies on updated information provided by the individual. However, OPM is considering the use of automated reinvestigative database checks in addition to a new investigative questionnaire.

One commenter recommended that 5 CFR part 731 be revised to provide general authority to take suitability actions, not only for limited situations currently described in part 731. The commenter believed this change would allow the suitability decision to remain with agency officials responsible for security, enhance consistency, and aid reciprocity. Another commenter recommended that OPM revise the regulations to allow agencies to take suitability actions whenever a new suitability investigation is conducted rather than limiting agency suitability actions to 1 year from the date an individual enters on duty. We did not accept these recommendations as they are beyond the scope of the proposed rule. Further, agencies' authority to take suitability actions is delegated by OPM under 5 U.S.C. 1104(a)(2), and cannot exceed the authority that OPM itself possesses. By regulation, OPM's own jurisdiction to take a suitability action against employees who have completed the first year of appointments subject to investigation is limited to those cases where the employee has committed falsification, deception or fraud in an examination or appointment; is disqualified under a statutory or regulatory bar to appointment; or has refused to testify when required to do so by Civil Service Rule V. See 5 CFR 731.103(g), 731.105(d). OPM does not interpret its suitability jurisdiction more broadly. Further, OPM declines to delegate to agencies the authority to take suitability actions against employees in these circumstances, because they are at the core of OPM's responsibility to protect the integrity of the competitive examining system and to impose government-wide debarments when appropriate. Moreover these are circumstances where there may be a conflict between OPM's and the agencies' interests, as recognized by 5 CFR 731.303(b).

One commenter stated that agencies should be delegated the authority to initiate subsequent reinvestigations based on changes in the position requirements and/or findings of misconduct. Another commenter asked why OPM doesn't issue a regulation moving this entire process to a “risk-based” process— i.e., requiring agencies to focus on the actual employees in public trust positions instead of requiring basically all employees to complete this periodic reinvestigation. A third commenter noted that OPM should issue implementing guidance allow public trust reinvestigations to be event-driven to resolve any new potentially adverse information. As previously stated, E.O. 13488 requires reinvestigations of all employees in public trust positions. If position requirements change, an agency should use OPM's Position Designation System to determine any new investigation requirement and subsequent reinvestigation requirements. As for event-driven situations or misconduct, another reinvestigation may or may not be appropriate. When the agency becomes aware of misconduct, it should take appropriate action. This may include fact-finding inquiries and an adverse action under 5 CFR part 752, if appropriate.

A commenter asked whether employees who have been employed for a long period of time will be subject to a less rigorous reinvestigation. Employees will not be subject to less rigorous reinvestigations simply because of their length of service. All public trust employees will be required to undergo reinvestigations at the level commensurate with their position designations.

A commenter stated that the agency conducting the reinvestigation does not appear to have authority under the proposed rule to take any negative action based upon a negative “assessment”. Another commenter asked what standards will be used to assess an employee's fitness after a reinvestigation. As noted above, since the Executive order requires a reinvestigation of “suitability for continuing employment” and defines “suitability” by reference to 5 CFR part 731, agencies should consider the substantive standards in § 731. 202, when evaluating the results of a public trust reinvestigation. As currently provided at 5 CFR 731.106(f), a person's employment status will determine the applicable agency authority and procedures to be followed in any action taken based on the results of the reinvestigation. If the character or conduct of an employee undermines the efficiency of the service, the agency may take an adverse action under 5 CFR part 752, if warranted. In addition, to provide further clarification as to the types of actions that can be taken against categories of probationary employees, we have modified the language in § 731.106(f) to include a reference to 5 CFR part 315 for appointees or 5 CFR part 359 for SES probationers.

A labor organization representative commented that the lack of a substantive need for a reinvestigation is illustrated by the narrow nature of the suitability action that could result from the reinvestigation. The labor organization representative further stated that there are better, less intrusive and more targeted ways to uncover and correct an employee's misconduct other than the “broad brush” of a reinvestigation. Another labor organization questioned the need to do reinvestigations when only a few investigations will uncover areas of concerns and most issues could not lead to disciplinary actions. We did not make changes to the rule as a result of these comments, which question the need for the Executive order rather than requesting a change to the proposed rule implementing the order.

A labor organization representative called on OPM to recommend to the Administration that it reexamine the need for reinvestigations for public trust positions. This comment is outside the scope of the rulemaking, so it cannot be considered by OPM as part of the rulemaking process.

A commenter stated that the rule should include a requirement that, prior to performing a reinvestigation, the employing agency must review and determine that the employee's position has been properly designated as to risk level. We did not adopt this recommendation, as agencies must use OPM's Position Designation System, and should re-designate positions as appropriate, such as when duties of the position change. OPM will not impose a requirement to review the position designation solely due to a pending reinvestigation. We note that our proposed amendment to 5 CFR 732.204 would require agencies to reassess the sensitivity designation of each national security position within a 24-month period. Proposed section 732.201(c) states that OPM will issue guidance under which an appropriate risk designation will automatically follow from the position's sensitivity designation. Agencies are free to reassess the risk designations of their nonsensitive public trust positions at the same time.

One commenter stated that it has a Continuous Evaluation Program (CEP) in place to identify, investigate, and adjudicate many of the same issues a public trust reinvestigation process would address. Further, the commenter suggested that focusing efforts on agency CEPs would reduce the need for more frequent reinvestigation cycles. Another commenter questioned whether or not there is redundancy between the reinvestigation and the FD-961 (Bioterrorism Preparedness Act: Entity/Individual Information) form. An investigation based on a CEP or the FD-961 that meets all requirements for reinvestigation or goes beyond those requirements may be sufficient. However, the commenters have not provided enough information about the content of the CEP or an FD-961 investigation; therefore, we are not able to determine if these investigations will satisfy the intended investigative requirement for public trust reinvestigations. These recommendations are not adopted because we do not have enough information to evaluate them.

A commenter recommended aligning fingerprinting requirements for periodic reinvestigations on public trust positions with those of reinvestigations for national security positions; and indicated that no fingerprinting is required in most periodic reinvestigations. Criminal checks will remain a critical component of reinvestigations, but whether or not fingerprinting for criminal checks will be required will be addressed in implementing guidance.

One commenter stated that it is using the National Agency Check with Inquiries (NACI) investigation in lieu of the Modified Background Investigation or Limited Background Investigation for moderate-risk public trust positions where the incumbent has no access to national security classified information. The NACI is not an appropriate level of investigation for Public Trust positions. OPM issued an October 2010 instruction to executive branch agencies regarding the appropriate investigations for moderate-risk public trust positions. The NACLC will be the reinvestigation required for moderate-risk public trust positions because it efficiently provides high-value information necessary to evaluate a person's continued suitability for a moderate-risk position. Future Federal investigative standards may redefine investigation and reinvestigation standards for public trust positions.

One commenter recommended OPM grant exemptions for reinvestigations on Minimum Background Investigations and revise the regulations to clarify or expand definitions of representative public trust position duties in 5 CFR 731.106. This recommendation is not adopted because the Executive order does not authorize OPM to grant exemptions from reinvestigation requirements, and because the definitions of representative public trust position duties are not within the scope of this rulemaking.

A commenter voiced a concern that OPM may propose that reinvestigations for moderate and high-risk positions be different from the continuous evaluation requirements (at the same tier level) approved in Federal Investigative Standards that were issued in December 2008, but never implemented. OPM declines to modify the rule to reference or align with standards that were not implemented. However, as previously noted, we recognize the need for alignment of reinvestigation requirements to the extent possible, and this alignment is reflected both in § 731.106(d)(2) of this final rule, and in proposed 5 CFR 732.203. Also as previously noted, new investigative standards are under development. The new investigative standards are targeted to be implemented in 2013.

Another commenter stated it is unclear why OPM is deferring establishing new investigative standards for public trust investigations until a later issuance, as this means that the rule offers little guidance on anything other than the frequency of reinvestigations. The commenter also stated that the rule cannot be implemented until guidance on the investigative standards is published. The purpose of this rulemaking is to prescribe the frequency of public trust reinvestigations. In the reopener, we also explained the investigative products we intend to use for public trust reinvestigations for non-sensitive positions: The NACLC and the PRI. Scope and coverage standards have already been established for these products. Investigations and adjudications have been proceeding throughout the period that OPM and other agencies have been working on alignment issues, and will continue to proceed after implementation of these regulations. OPM therefore disagrees with the commenter's assertion that introducing changes to the suitability rule that are required by Executive Order is somehow inappropriate or that there is insufficient guidance to implement the rule. Further, as alignment efforts move forward, new investigative standards and products will be developed, but it is neither necessary nor desirable to codify the scope and coverage standards for investigative products in permanent rules.

Some commenters stated that the term “assessment” caused confusion. One commenter suggested we use the term “decision” instead, as “assessment” implies observation and evaluation. Another commenter stated that OPM did not adequately explain why it is proposing to replace “determination” with “assessment.” The commenter recommended that the language remain as it is in the current rule and include new language that states what action must be taken as a result of a reinvestigation. A commenter recommended we change the term “assessment” back to “determination,” as this commenter believed that any final decision regarding an individual's continued suitability for Federal employment based upon a completed investigation should be called a “determination” for consistency across agencies. Another commenter recommended that OPM outline what happens after a completed suitability investigation (“determination”) and what happens after a completed reinvestigation (“assessment”). The commenter also stated that the term “assessment” needs to be further defined or explained. Only one commenter indicated that the term “assessment” clarified the process.

Since use of the term “assessment” has not provided clarification as intended, in § 731.106(d)(1) we have changed the term back to “determination,” to reflect the decision-making process associated with ensuring suitability for continuing employment. In the context of this rule, the “determination” is a decision as to whether or not to take a suitability action, adverse action, or probationary action, or to refer a case to OPM for adjudication, as appropriate. An adverse action, if taken, must meet statutory procedural requirements. E.O. 13488 does not require an agency to take an adverse action when it otherwise would not be warranted.

To provide further clarification as to the types of actions that can be taken against categories of employees, we have modified the language in § 731.106(f) to include a reference to 5 CFR part 315 for probationers or 5 CFR part 359 for Senior Executive Service (SES) probationers. We have also changed § 731.106(e) to include appointees as well as employees, as changes in risk levels can occur with respect to both.

Some labor organization representatives expressed concerns that sufficient information was not provided to enable them to comment in a meaningful fashion regarding the frequency of reinvestigation. We disagree. This rule was originally proposed on November 3, 2009, and reopened on November 5, 2010, to specifically solicit comments on the reinvestigation cycle. The new notice provided adequate information about the intended reinvestigation products. Despite continuing concerns expressed on lack of information, a number of substantive comments were still provided by these parties regarding frequency of reinvestigation.

Some commenters observed that the proposed rule does not contain language addressing how breaks in service affect investigative requirements. As a result, they recommended that OPM amend the proposed rule to clarify that a break in service of less than 24 months would not require a new investigation. They argued that this would support the goals of reciprocity and alignment between suitability and national security investigations. OPM agrees and has revised § 731.104(a) to clarify that a new investigation is not required when there has been a break in service of less than 24 months.

One agency commenter and a labor organization representative expressed the opinion that implementation of these regulations may require collective bargaining for employees in bargaining units prior to implementation. The commenters made no specific recommendations, so no changes were made to the rule.

A labor organization representative commented that implementation of these regulations will have a negative impact on labor relations and Federal employees and recommends that the National Council on Federal Labor-Management Relations review the rule and make recommendations to the President on whether to proceed with the rule. This labor organization representative also proposed that OPM hold the rule in abeyance until the President decides whether or not to proceed with it. The labor organization representative did not provide any additional information regarding the perceived negative impact on labor relations and Federal employees. We did not adopt these recommendations. The rulemaking is required by E.O. 13488. As long as the E.O. remains in place, there is no basis for OPM to submit this rule for the National Council's review or to hold it in abeyance. The proposed rule dated November 3, 2009, and the reopener dated November 5, 2010, were provided to all unions with Governmentwide consultation rights with OPM for their comments and recommendations regarding the rule. Additionally, agencies, members of the public, and other labor organizations were also provided an opportunity to comment on the proposed rule.

One commenter stated that a review should be made as to whether agencies will initiate adverse action proceedings should off-duty criminal conduct be discovered, when the conduct does not have a nexus to the service. OPM did not adopt this recommendation as it is outside the scope of this rule. However, as stated earlier, 5 CFR 731.106(f) currently provides that a person's employment status will determine the applicable agency authority and procedures to be followed in any action taken based on the results of the reinvestigation. This rule prescribes reinvestigation requirements, and cannot be read to amend the statutory standard for bringing an adverse action under 5 U.S.C. chapter 75. Under this standard an adverse action must have a nexus with the efficiency of the service.

One commenter stated that OPM's separate proposal to amend part 732 will, if adopted, have the effect of broadening the categories of position duties that are categorized as “sensitive” and, as a result, OPM should not make references in part 731 to the representative position duties of “public trust” positions. The definition of representative “public trust” position duties in 5 CFR 731.106(b) is not within the text that OPM proposed to amend in the rule, so the comment is outside the scope of the rulemaking. Nonetheless, we note that the commenter appears to assume that national security positions do not also have a public trust risk designation. This assumption is incorrect under § 731.106(b)(2). We also note that the commenter's statement about the possible effect of OPM's proposal to amend part 732 is speculative. As we noted in the Supplementary Information accompanying the notice of proposed rulemaking, the proposed rule contains text intended to address the risk of over-designating national security positions as well as the risk of under-designating such positions.

One commenter stated that directing agencies to make an “assessment” of whether findings of an investigation would justify an action against an employee will take the decision out of the personnel security arena and place it into the employee and labor relations arena. While we have agreed to retain the term “determination” instead of “assessment,” there is no intended change in how these actions are handled in an agency. OPM is aware that some agencies conduct suitability reviews as a human resources function, while other agencies conduct such reviews as a security function. It is not OPM's intent in this rulemaking to prescribe which internal component of an agency will conduct a function.

One commenter stated that, given the reporting requirement, the agency will have to complete the INV Form 79A, Report of Adjudicative Action on OPM Personnel Investigations. The agency further stated that this requirement will place the burden on personnel security divisions to report on actions that may be taken by other offices. While agencies have responsibilities to comply with this rule, it is up to each agency to determine how it will do so.

One commenter questioned why OPM doesn't issue a regulation regarding how employees can dispute the designation of their positions as public trust positions. This question is beyond the scope of the proposed rule, which is limited to the frequency of reinvestigations. However, because the position designation process is a discretionary agency decision, employees should consult with their agency human resources office regarding whether any administrative procedures are available to employees if they wish to dispute whether rules and regulations have been properly applied.

One commenter questioned how designations of public trust positions are made, and recommended that OPM clarify the definition of public trust position duties in its regulation. Designations of public trust positions and their risk levels are made by agencies following OPM guidance and taking into account the specific duties of each position. The comment that OPM should clarify the definition of public trust position duties in the rule cannot be considered because it addresses matters outside the scope of the rulemaking.

Finally, OPM is updating the authority citation for part 731 to include a reference to E.O. 13488. We also are making a correction to the citation format.

OPM has determined that this rule will not have a significant economic impact on a substantial number of small entities because they will apply only to Federal agencies and employees.

This rule has been reviewed by the Office of Management and Budget in accordance with E.O. 13563 and E.O. 12866.

This regulation will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant preparation of a Federalism Assessment.

This regulation meets the applicable standard set forth in section 3(a) and (b)(2) of Executive Order 12988.

This regulation will not result in the expenditure by State, local, or Tribal governments of more than $100 million annually. Thus, no written assessment of unfunded mandates is required.

This action pertains to agency management, personnel and organization and does not substantially affect the rights or obligations of non- agency parties and, accordingly, is not a “rule” as that term is used by the Congressional Review Act (Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA)). Therefore, the reporting requirement of 5 U.S.C. 801 does not apply.

This final regulatory action will not impose any additional reporting or recordkeeping requirements under the Paperwork Reduction Act.

Accordingly, OPM amends part 731, title 5, Code of Federal Regulations, as follows:

On August 2, 2011, the FAA published in the Federal Register a notice of proposed rulemaking (NPRM) to modify controlled airspace at Blythe, CA (76 FR 46212). Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Subsequent to publication, the FAA found that the boundaries for the controlled airspace needed to be adjusted; this action makes that adjustment.

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 designations listed in this document will be published subsequently in that Order.

This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace extending upward from 700 feet above the surface to accommodate IFR aircraft executing RNAV (GPS) standard instrument approach procedures at Blythe Airport. Also, the boundary coordinates in the regulatory text for the Class E 1,200-foot airspace area is adjusted to be in concert with the FAA's aeronautical database. This action is necessary for the safety and management of IFR operations. With the exception of editorial changes and the changes noted above, this rule is the same as that proposed in the NPRM.

The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this 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 rule, when promulgated, will 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 discusses the authority of 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 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 creates additional controlled airspace at Blythe Airport, Blythe, CA.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Background Authorization Validated End-User (VEU)

BIS amended the EAR in a final rule on June 19, 2007 (72 FR 33646), creating a new authorization for “validated end-users” (VEUs) located in eligible destinations to which eligible items may be exported, reexported, or transferred (in-country) under a general authorization instead of a license, in conformance with section 748.15 of the EAR. VEUs may obtain eligible items that are on the Commerce Control List, set forth in Supplement No. 1 to Part 774 of the EAR, without having to wait for their suppliers to obtain export licenses from BIS. Eligible items may include commodities, software, and technology, except those controlled for missile technology or crime control reasons.

The VEUs listed in Supplement No. 7 to Part 748 of the EAR were reviewed and approved by the U.S. Government in accordance with the provisions of section 748.15 and Supplement Nos. 8 and 9 to Part 748 of the EAR.

In a rule published in the Federal Register on October 19, 2007 (72 FR 59164), BIS designated National Semiconductor as a VEU and identified three of its facilities (NSC VEU facilities) as “Eligible Destinations,” thus authorizing exports, reexports, and transfers (in-country) of certain eligible items to the three eligible facilities under Authorization VEU. Due to a material change in the ownership and control of National Semiconductor, National Semiconductor asked that its VEU authorization be ended. Accordingly, consistent with section 748.15 of the EAR, BIS now amends Supplement No. 7 to Part 748 of the EAR to remove National Semiconductor from the list of approved VEUs and eligible destinations. As a result of this rule, National Semiconductor Corporation and the NSC VEU facilities at the following addresses are no longer authorized to receive items under Authorization VEU:

This amendment is made due to a material change in the ownership and control of National Semiconductor and is not the result of activities of concern by National Semiconductor or the NSC VEU facilities. This action does not establish any new license requirements or licensing policies for exports, reexports or transfers (in-country) of items to National Semiconductor. Rather, the license requirements set forth in the EAR continue to apply to this entity and its facilities. Parties seeking to export, reexport or transfer (in-country) items under the EAR to National Semiconductor or these facilities may now have to obtain a license to do so, depending on the item at issue.

All conditions and restrictions that applied to transactions that were undertaken pursuant to Authorization VEU prior to the effective date of this amendment that involved National Semiconductor or the NSC VEU facilities continue to apply to those transactions. These restrictions and conditions include any that were imposed on National Semiconductor or the NSC VEU facilities in connection with its eligibility for Authorization VEU, as established by BIS in its communications authorizing National Semiconductor's participation in the VEU program.

In a rule published in the Federal Register on October 19, 2007 (72 FR 59164), BIS designated SMIC as a VEU, thus authorizing certain specific exports, reexports and transfers (in-country) to five listed facilities of the company, including the SMIC AT2 facility. Due to a material change in the ownership and control of the SMIC AT2 facility, SMIC has requested that BIS remove that facility's VEU authorization. Accordingly, in this rule, BIS further amends Supplement No. 7 to Part 748 of the EAR to remove the SMIC AT2 facility and its address (8-8 Kexin Road, Export Processing Zone (West Area), Chengdu, China 611731) from the list of SMIC's authorized VEU facilities. This change leaves three SMIC facilities that are approved to receive eligible items under SMIC's VEU authorization.

As a result of this rule, the SMIC AT2 facility is no longer authorized to receive items under Authorization VEU. Thus, parties seeking to export, reexport, or transfer (in-country) items under the EAR to the SMIC AT2 facility may now need to obtain a license to do so, depending on the item at issue.

This amendment is made due to a material change in the ownership and control at the SMIC AT2 facility and is not the result of activities of concern by the SMIC AT2 facility or SMIC. SMIC remains a qualified participant in the VEU program, and thus exports, reexports and transfers (in-country) of the items controlled under the ECCNs listed in SMIC's entry in Supplement No. 7 to Part 748 of the EAR to the SMIC facilities listed in the same part may continue to be made under Authorization VEU. This action does not establish any new license requirements or licensing policies for exports, reexports or transfers (in-country) of items to the SMIC AT2 facility. Rather, the license requirements set forth in the EAR continue to apply to this entity and its facilities.

This amendment applies only to transactions under Authorization VEU involving the SMIC AT2 facility. All conditions and restrictions that applied to transactions that were undertaken pursuant to Authorization VEU prior to the effective date of this amendment, and that involved the SMIC AT2 facility, continue to apply to those transactions. These restrictions and conditions include any that were imposed on the SMIC AT2 facility in connection with its eligibility for Authorization VEU, as established by BIS in its communications authorizing the SMIC AT2 facility's participation in the VEU program.

Shipments of items removed from eligibility for export, reexport or transfer (in-country) under Authorization VEU ( i.e., under the designator VEU) as a result of this regulatory action that were on dock for loading, on lighter, laden aboard an exporting carrier, or en route aboard a carrier to a port of export, on November 9, 2011, pursuant to actual orders for export, reexport or transfer (in-country) to an eligible destination, may proceed to that destination under the previously applicable Authorization so long as they are exported, reexported or transferred (in-country) before November 25, 2011. Any such items not actually exported, reexported or transferred (in-country) before midnight, on November 25, 2011, require an individual license or other applicable authorization under the EAR.

Since August 21, 2001, the Export Administration Act (the Act) has been in lapse and the President, through Executive Order 13222 of August 17, 2001 (3 CFR, 2001 Comp., p. 783 (2002)), as extended most recently by the Notice of August 12, 2011, 76 FR 50661 (August 16, 2011), has continued the EAR in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222.

1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. This rule involves collections previously approved by the Office of Management and Budget (OMB) under Control Number 0694-0088, “Multi-Purpose Application,” which carries a burden hour estimate of 43.8 minutes to prepare and submit form BIS-748; and for recordkeeping, reporting and review requirements in connection with Authorization VEU, which carries an estimated burden of 30 minutes per submission. This rule is expected to result in a decrease in license applications submitted to BIS. Total burden hours associated with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA) and OMB Control Number 0694-0088 are not expected to increase significantly as a result of this rule.

Notwithstanding any other provisions of law, no person is required to respond or to be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.

3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.

4. There is good cause under 5 U.S.C. 553(b)(B) to waive the provisions of the Administrative Procedure Act (APA) requiring prior notice and the opportunity for public comment because, specific to this rule, they are unnecessary, impracticable, and contrary to the public interest.

In determining whether to grant or revoke VEU designations, a committee of U.S. Government agencies evaluates a variety of information, the nature and terms of which are set forth in 15 CFR part 748, supplement No. 8. The criteria for evaluation by the committee are set forth in 15 CFR 748.15(a)(2). The information, commitments, and criteria for this extensive review were all established through the notice of proposed rulemaking and public comment process (71 FR 38313, July 2, 2006, and 72 FR 33646, June 19, 2007). Thus, authorization of a VEU is similar to granting a license: To receive authorization VEU, an application must be submitted on behalf of an entity; the entity must be found to meet certain previously identified criteria; and the application must be approved. Because the authorization granted by BIS pursuant to 15 CFR 748.15 is similar to that granted to exporters for individual licenses, which do not undergo public review when they are approved, denied, revoked, or amended, allowing public review and comments to this rule is unnecessary.

Publication of this rule in other than final form is unnecessary because the procedure for revocation of a VEU or facility from the Authorized VEU list is similar to the license revocation procedure, which does not undergo public review. During the revocation procedure, the U.S. Government analyzes confidential business information according to set criteria to determine whether a given authorized VEU entity remains eligible for VEU status. Revocation may, as in this case, be the result of a material change in circumstance at the VEU or the VEU's authorized facility. Examples of such a material change include changes in the operational status of a VEU facility or changes in the end-use of the products produced at the facility. Such changes may result in a VEU or VEU facility no longer meeting the eligibility criteria for Authorization VEU, and may thus lead the U.S. Government to modify or revoke VEU authorization. VEUs or VEU facilities that undergo material changes that result in their no longer meeting the criteria to be eligible VEUs must, according to the VEU program, have their VEU status revoked. Here, National Semiconductor requested removal from the VEU program and SMIC requested that BIS remove the SMIC AT2 facility from the VEU program due to material changes in ownership and control. Consequently, BIS is removing National Semiconductor from the list of “Validated End-Users” and “Eligible Destinations” and removing the SMIC AT2 facility from “Eligible Destinations” in the EAR. Public comments on whether to make these removals are unnecessary.

Additionally, allowing for prior public notice and comment on this rule may be impracticable and contrary to the public interest. The EAR advance U.S. national security, foreign policy, and economic objectives by ensuring an effective export control system. In accordance with the pre-set criteria, the U.S. Government reviews each VEU and its facilities to ensure that exports, reexports and transfers (in-country) of specified items to these entities are consistent with such objectives. Accordingly, VEUs and their facilities may receive through export, reexport or transfer (in-country) items that would otherwise require a license and transaction-specific review, in part due to national security concerns. However, the VEU and listed facility here are no longer eligible to receive items under Authorized VEU, and in order to protect national security, the restrictions of the EAR must be in place as soon as possible. Allowing public comments on this rule would hinder the ability of BIS to enforce the EAR's restrictions on exports without a license to the listed facilities. Thus public comment on this rule is both impracticable, because allowing such comment would prevent BIS from undertaking its statutory duties, and contrary to the public's national security interests.

In addition, BIS finds good cause to waive the requirement of 5 U.S.C. 553(d)(3) to delay the effectiveness of this regulation, because such a delay is contrary to the public's interest. When the U.S. Government has been notified of or has identified a material change in circumstances that warrants revocation or modification of VEU status for an end-user or a facility of an end-user, there is a need to quickly alert the public that the facility is no longer authorized as a recipient of items under Authorization VEU. Delaying this action's effectiveness could result in items that otherwise require licenses being exported, reexported, or transferred (in-country), license-free, to an ineligible facility, at risk to national security. Accordingly, it would be contrary to the public interest to delay this rule's effectiveness.

No other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this final rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under the APA or by any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable and no regulatory flexibility analysis has been prepared.

Accordingly, part 748 of the EAR (15 CFR parts 730-774) is amended as follows:

Section 126.1(v) is added to set out U.S. policy on arms exports to the Republic of the Sudan, in accordance with UN Security Council resolutions imposing an arms embargo and recent political developments in Sudan. UNSC resolution 1556, adopted July 30, 2004, imposes an arms embargo on non-governmental entities and individuals operating in Darfur, with certain exceptions. Subsequently, UNSC resolution 1591, adopted on March 29, 2005, expanded the arms embargo to all parties to the N'djamena Ceasefire Agreement, including the Government of the Republic of Sudan. UNSC resolution 1945, adopted on October 14, 2010, reaffirmed and strengthened the arms embargo. Accordingly, it is the policy of the United States to deny licenses or other approvals for exports or imports of defense articles and defense services destined for or originating in the Republic of the Sudan. The exceptions, as provided in the referenced resolutions, are for (1) Supplies and related technical training and assistance to monitoring, verification, or peace support operations, including those authorized by the UN or operating with the consent of the relevant parties; (2) supplies of non-lethal military equipment intended solely for humanitarian, human rights monitoring, or protective uses, and related technical training and assistance; (3) personal protective gear for the personal use of United Nations personnel, human rights monitors, representatives of the media, and humanitarian and development workers and associated personnel; and (4) assistance and supplies provided in support of implementation of the Comprehensive Peace Agreement. Licenses submitted pursuant to these exceptions will be considered on a case-by-case basis.

Sections 126.1(c) and (d) are revised to change “Sudan” to “The Republic of the Sudan.”

On July 9, 2011, the Republic of South Sudan declared independence from Sudan and was recognized as a sovereign state by the United States. The policy of denial as it applies to the Republic of the Sudan does not apply to the Republic of South Sudan. Licenses or other approvals for exports or imports of defense articles and defense services destined for or originating in the Republic of the South Sudan will be considered on a case-by-case basis.

The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from § 553 (Rulemaking) and § 554 (Adjudications) of the Administrative Procedure Act. Since the Department is of the opinion that this rule is exempt from 5 U.S.C. 553, it is the view of the Department of State that the provisions of § 553(d) do not apply to this rulemaking. Therefore, this rule is effective upon publication. The Department also finds that, given the national security issues surrounding U.S. policy towards the Republic of the Sudan, notice and public procedure on this rule would be impracticable, unnecessary, or contrary to the public interest; for the same reason, the rule will be effective immediately. See 5 U.S.C. 808(2).

Since this amendment is not subject to 5 U.S.C. 553, it does not require analysis under the Regulatory Flexibility Act.

This amendment does not involve a mandate that will 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 year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.

This amendment has been found not to be a major rule within the meaning of the Small Business Regulatory Enforcement Fairness Act of 1996.

This amendment 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, it is determined that this amendment does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this amendment.

The Department is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules governing the conduct of this function are exempt from the requirements of Executive Order 12866. However, the Department has reviewed the proposed rule to ensure its consistency with the regulatory philosophy and principles set forth in the Executive Order.

The Department of State has reviewed the proposed amendment in light of sections 3(a) and 3(b) (2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.

The Department of State has considered this rule in light of Executive Order 13563, dated January 18, 2011, and affirms that this regulation is consistent with the guidance therein.

The Department has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not pre-empt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.

This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35.

Accordingly, for the reasons set forth above, Title 22, Chapter I, Subchapter M, part 126 is amended as follows:

On June 29, 2011, we published a notice of proposed rulemaking (NPRM) entitled Special Local Regulations and Safety Zones; Recurring Events in Captain of the Port New York Zone in the Federal Register (76 FR 125). We received no comments on the proposed rule. No public meeting was requested and none was held.

The legal basis for the proposed rule is 33 U.S.C. 1225, 1226, 1231, 1233; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define regulatory safety zones and special local regulations.

Swim events, fireworks displays, and marine events are held on an annual recurring basis on the navigable waters within the COTP New York Zone. In the past, the Coast Guard has established special local regulations, regulated areas, and safety zones for these annual recurring events on a case by case basis to ensure the protection of the maritime public and event participants from the hazards associated with these events. The Coast Guard has not received public comments or concerns regarding the impact to waterway traffic from these annually recurring events.

This rule will consistently apprise the public in a timely manner through permanent publication in Title 33 of the Code of Federal Regulations. The TABLES in this regulation list each annual recurring event requiring a regulated area as administered by the Coast Guard.

By establishing a permanent regulation containing these annual recurring events, the Coast Guard would eliminate the need to establish temporary rules for events that occur on an annual basis, thereby, limiting the costs associated with cumulative regulations.

This rulemaking has removed, added, and consolidated regulations that better meet the Coast Guard's intended purpose of ensuring safety during these events.

The Coast Guard is adding 33 CFR 100.150 and consolidating sections 33 CFR 165.161, 165.162, 165.166, 165.168, 165.170 into a new section, 33 CFR 165.160. The rule applies to the annual recurring events listed in the attached Tables in the COTP New York Zone. The Tables provide the event name, and type, as well as locations of the events. The specific times, dates, regulated areas, and enforcement period for each event will be provided through the Local Notice to Mariners, Broadcast Notice to Mariners and online at http://homeport.uscg.mil/newyork or through a Notice of Enforcement published in the Federal Register .

During enforcement periods, the safety zones in TABLE 1 to § 165.160 will be enforced from 6 p.m. to 1 a.m. each day a barge with a “Fireworks—Stay Away” sign on the port and starboard side is on-scene or a “Fireworks—Stay Away” sign is posted on land adjacent to the shoreline, in a location listed in the TABLE 1 to § 165.160. Vessels may enter, remain in, or transit through these safety zones during this time frame if authorized by the COTP New York or the designated representative.

The particular size of the safety zones established for each event will be reevaluated on an annual basis in accordance with Navigational and Vessel Inspection Circular (NVIC) 07-02, Marine Safety at Firework Displays, the National Fire Protection Association Standard 1123, Code for Fireworks Displays (30-yard distance per inch of diameter of the fireworks mortars), and other pertinent regulations and publications.

This regulation will prevent vessels from transiting areas specifically designated as special local regulations or safety zones during the periods of enforcement to ensure the protection of the maritime public and event participants from the hazards associated with the listed annual recurring events. Only event sponsors, designated participants, and official patrol vessels will be allowed to enter regulated areas. Spectators and other vessels not registered as event participants may not enter the safety zones without the permission of the COTP or the designated representative.

The Coast Guard made the following changes to the published NPRM regulatory text:

Safety zones listed in Table 1 to § 165.160 have been reordered and renumbered to more accurately reflect their geographical locations. In the published NPRM regulatory text, the Rumson, NJ, Safety Zone and the Red Bank, NJ, Safety Zone were listed under the heading “New York Harbor” in Table 1 to § 165.160 and numbered as 2.16 and 2.17. They are now listed under the “Navesink River” heading in Table 1 to § 165.160 and numbered 7.2 and 7.3 respectively.

Keyport, NJ, Safety Zone was not included in the NPRM and is now listed under the heading “Navesink River” and numbered as 7.1. Since The Coast Guard has previously established a temporary safety zone at this location in the past and has not received public comments or concerns regarding the impact to waterway traffic, we decided it should be included in this recurring events regulation.

In the regulatory text under § 165.160(a), the existing text reads as follows: “Notifications of exact dates and times of the enforcement period will be made to the local maritime community through the Local Notice to Mariners and Broadcast Notice to Mariners or through a Notice of Enforcement in the Federal Register well in advance of the events”. We revised the text to help the public better understand our intentions regarding notification of enforcement of the safety zones.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, 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 rule to be minimal. Although this regulation may have some impact on the public, the potential impact will be minimized for the following reasons:

The Coast Guard has previously promulgated safety zones or special local regulations, in accordance with 33 CFR Parts 100 and 165, for all event areas contained within this regulation and has not received notice of any negative impact caused by any of the safety zones or special local regulations. By establishing a permanent regulation containing all of these events, the Coast Guard will eliminate the need to establish individual temporary rules for each separate event that occurs on an annual basis, thereby limiting the costs of cumulative regulations.

Vessels will only be restricted from safety zones and special local regulation areas for a short duration of time. Vessels may transit in portions of the affected waterway except for those areas covered by the regulated areas. Notifications of exact dates and times of the enforcement period will be made to the local maritime community through the Local Notice to Mariners and Broadcast Notice to Mariners or through a Notice of Enforcement in the Federal Register . No new or additional restrictions would be imposed on vessel traffic.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: Owners or operators of vessels intending to transit, fish, or anchor in the areas where the listed annual recurring events are being held.

The rule would not have a significant economic impact on a substantial number of small entities for the following reasons: Vessels will only be restricted from safety zones and special local regulation areas for a short time; vessels may transit in portions of the affected waterway except for those areas covered by the regulated areas; the Coast Guard has promulgated safety zones or special local regulations in accordance with 33 CFR parts 100 and 165 for all event areas in the past and has not received notice of any negative impact caused by any of the safety zones or special local regulations; notifications of exact dates and times of the enforcement period will be made to the local maritime community through the Local Notice to Mariners and Broadcast Notice to Mariners or through a Notice of Enforcement in the Federal Register . No new or additional restrictions would be imposed on vessel traffic.

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

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

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

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

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

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

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

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

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

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

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

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

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR Parts 100 and 165 as follows:

On June 28, 2011, we published a notice of proposed rulemaking (NPRM) entitled: Special Local Regulations and Safety Zones; Recurring Events in Captain of the Port Boston Zone, in the Federal Register (76 FR 37690). We did not receive any comments on the proposed rule. No public meeting was requested, and none was held.

The legal basis for this rule is 33 U.S.C. 1226, 1231, 1233; 46 U.S.C. Chapter 454, 701, 3306, 3703; 50 U.S.C. 191, 195; Public Law 107-295, 116 Stat. 2064; and Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to define regulatory safety zones and SLRs.

Marine events are annually held on a recurring basis on the navigable waters within the Coast Guard COTP Boston Zone. These events include fireworks displays, swim events, and other marine events. In the past, the Coast Guard has established SLRs, regulated navigation areas, and safety zones for these events individually to ensure the protection of the maritime public and event participants from the hazards associated with these marine events. Issuing individual regulations annually has proved to be administratively cumbersome.

This rule will significantly relieve administrative overhead and consistently apprise the public in a timely manner through permanent publication in Title 33 of the Code of Federal Regulations. The Tables in this regulation list each recurring marine event requiring a regulated area as administered by the Coast Guard.

By establishing a permanent regulation containing these events, the Coast Guard will eliminate the need to establish temporary rules for events that occur on an annual basis. This limits the unnecessary burden of continually establishing temporary rules every year.

This rulemaking amends, removes, and adds regulations that better meet the Coast Guard's intended purpose of ensuring safety during these events.

The Coast Guard has also identified a number of events in 33 CFR part 100 which would be more appropriately located in 33 CFR part 165. This rule amends local regulations contained in 33 CFR part 100 to move firework displays to part 165, a citation that better meets the Coast Guard's intended purpose of ensuring safety during these events.

The Coast Guard has promulgated safety zones or SLRs for these areas in the past, and has not received public comments or concerns regarding the impact to waterway traffic from these annually recurring events.

The Coast Guard is revising section 33 CFR 100.114, and adding sections 33 CFR 100.130, and 33 CFR 165.118. The changes remove nine outdated regulated areas and establish 43 new permanent regulated areas. The rule applies to each recurring marine event listed in the attached TABLES in the Coast Guard COTP Boston Zone. The TABLES provide the event name, sponsor, and type, as well as approximate dates and locations of the events. Notifications will be made to the local maritime community through the Local Notice to Mariners and/or Broadcast Notice to Mariners well in advance of the events. If the event does not have a date listed, then exact dates and times of the enforcement period will be announced through a Notice of Enforcement in the Federal Register .

The particular size of the safety zones established for each event will be reevaluated on an annual basis in accordance with Navigational and Vessel Inspection Circular (NVIC) 07-02, Marine Safety at Firework Displays, the National Fire Protection Association Standard 1123, Code for Fireworks Displays (70-foot distance per inch of diameter of the fireworks mortars), and other pertinent regulations and publications.

This regulation prevents persons and vessels from transiting areas specifically designated as SLRs or safety zones during the periods of enforcement to ensure the protection of the maritime public and event participants from the hazards associated with listed marine events. Only event sponsors, designated participants, and official patrol vessels will be allowed to enter safety zones and SLR areas. Spectators and other vessels not registered as event participants may not enter the regulated areas without the permission of the COTP or the designated representatives.

All persons and vessels shall comply with the instructions of the COTP Boston or the designated on-scene representative. Entering into, transiting through, mooring or anchoring within the regulated areas is prohibited unless authorized by the COTP Boston or the designated on scene representative.

We did not receive any comments to the proposed rule.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, 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.

The Coast Guard determined that this rule is not a significant regulatory action for the following reasons: vessels will only be restricted from safety zones and SLR areas for a short duration of time unless otherwise noted; vessels may transit in portions of the affected waterway except for those areas covered by the safety zones; the Coast Guard has promulgated safety zones or SLRs in accordance with 33 CFR parts 100 and 165 for all event areas in the past and has not received notice of any negative impact caused by any of the safety zones or SLRs. Reasonable notifications will also be made by Local Notice to Mariners (LNM) and Broadcast Notice to Mariners (BNM) well in advance of the events.

The effect of this action simply establishes locations or the approximate dates on which the existing regulations would be enforced and consolidates them within one regulation. No new or additional restrictions would be imposed on vessel traffic.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule will affect the following entities, some of which may be small entities: owners or operators of vessels intending to transit, fish, or anchor in the areas where marine events are being held. For the reasons outlined above, this rule would not have a significant impact on a substantial number of small entities.

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

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

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

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

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

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

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

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

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

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

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

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

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

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR parts 100 and 165 as follows:

Norfolk and Southern Railroad Corporation, who owns and operates the Neuse River Railroad Bridge, mile 34.2, at New Bern, NC, requested a temporary deviation from the current operating regulations to facilitate repairs to the main mechanism of the bridge.

Under the regular operating schedule, the swing bridge opens on signal as required by 33 CFR 117.5. In the closed position to vessels, the bridge has no available vertical clearance.

To facilitate repairs, the swing span will be closed to vessels requiring an opening from 9 a.m. on November 15, 2011 until and including 6 p.m. on November 17, 2011. There are no alternate routes for vessels transiting this section of the Neuse River.

The majority of the vessels that transit through this bridge during this time of year are recreational with intermittent tug and barge traffic.

The Coast Guard has carefully coordinated the restrictions with commercial and recreational waterway users. The Coast Guard will inform all users of the waterway through our Local and Broadcast Notice to Mariners of the closure periods for the bridge so that vessels can arrange their transits to minimize any impacts caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the draw must return to its original operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Union Pacific Railroad has requested a temporary deviation from the operating schedule for the swing span bridge across the Calcasieu River, mile 36.4, at Westlake, Calcasieu Parish, Louisiana. The swing span bridge has a vertical clearance of 1.07 feet above mean high water, elevation 3.56 feet Mean Gulf Level in the closed-to-navigation position.

In accordance with 33 CFR 117.5, the bridge currently opens on signal for the passage of vessels. This deviation allows the swing span of the bridge to remain closed-to-navigation from 8 a.m. through 6 p.m. on Thursday, November 10, Thursday, November 17, and Thursday, November 24, 2011. The swing span of the bridge will open for the passage of vessels from 12 noon to 1 p.m. on Thursday, November 17 and Thursday, November 24, 2011.

The closures are necessary in order to remove the existing structural steel, shafts, and gears; and to install two new main drive motors, gears, and wiring on both sides of the pivot pier of the turn span. This maintenance is essential for the continued operation of the bridge. Notices will be published in the Eighth Coast Guard District Local Notice to Mariners and will be broadcast via the Coast Guard Broadcast Notice to Mariners System.

Navigation on the waterway is minimal at the bridge site. The very limited commercial traffic at the bridge site consists of commercial tugs with tows. There are only two companies that transit above the bridge. The bridge will be able to open for emergencies if necessary. There are no alternate waterway routes available. Based on experience and coordination with waterway users, it has been determined that these closures will not have a significant effect on vessels that use the waterway.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Norfolk Southern Corporation, who owns and operates this single-leaf bascule drawbridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.997(e) to facilitate laying new rail.

Under the current operating schedule, the bridge shall be left in the open position at all times and will only be lowered for the passage of trains and to perform periodic maintenance. The Norfolk Southern #7 Bridge, at AIWW mile 5.8, across the Elizabeth River (Southern Branch) in Chesapeake, VA, has a vertical clearance in the closed position to vessels of 7 feet above mean high water.

To facilitate laying new rail, the drawbridge will be maintained in the closed-to-navigation position from 7 a.m. to 5 p.m. on November 28 and 29, 2011. The bridge normally operates in the open position with several vessels transiting a week. Coordination with waterway users has been completed.

The Coast Guard will inform the users of the waterway through our Local and Broadcast Notices to Mariners of the opening restrictions of the draw span to minimize transiting delays caused by the temporary deviation. There are no alternate routes available but vessels may pass between 5 p.m. and 7 a.m. Mariners able to pass under the bridge in the closed position may do so at any time and the bridge is able to open for emergencies. Mariners are advised to proceed with caution.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period.

This deviation from the operating regulations is authorized under 33 CFR 117.35.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing an NPRM is impracticable and contrary to public interest since immediate action is needed to minimize potential danger to the public during the event. The Coast Guard did not receive notification of date change for this event in sufficient time to issue an NPRM and hold a comment period for this rulemaking. The potential dangers posed by fallout from pyrotechnic fireworks displays to vessel traffic transiting the waterway makes this safety zone necessary to provide for the safety of spectator craft and other vessels transiting the event area. For the safety concerns noted, it is in the public interest to have these regulations in effect during the event. The Coast Guard will issue broadcast notice to mariners to advise vessel operators of navigational restrictions. On scene Coast Guard and local law enforcement vessels will also provide actual notice to mariners.

Under 5 U.S.C. 553(d)(3), and for the same reasons, the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date would be contrary to the public interest, since immediate action is needed to ensure the safety of the event participants, spectator craft and other vessels transiting the event area.

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 temporarily changes the enforcement period and geographic location of the safety zone for one recurring marine event, described at (d)(10) of the Table to 33 CFR 165.506, that is normally scheduled to occur each year on the 4th Monday in November. This year, the event will take place on the 4th Saturday, November 26, 2011.

On November 26, 2011, the North Carolina Holiday Flotilla at Wrightsville Beach, NC, will sponsor the “2011 NC Holiday Flotilla boat parade and fireworks”. The event will take place near Wrightsville Beach, NC, on the waters of Motts Channel and Banks Channel. The regulation at 33 CFR 165.506 is enforced annually for this event. The event will consist of approximately 40 sailboats and powerboats participating in a parade in the vicinity of the Wrightsville Beach, NC, and conclude with a fireworks display. Also, a fleet of spectator vessels is expected to gather near the event site to view the parade and fireworks. To provide for the safety of participants, spectators, and transiting vessels, the Coast Guard will temporarily restrict vessel traffic in the event area from 5:30 p.m. to 8:30 p.m. on November 26, 2011. The regulation at 33 CFR 165.506 will be enforced for the duration of the event. Vessels may not enter the regulated area unless they receive permission from the Coast Guard Patrol Commander.

The Coast Guard is temporarily changing the enforcement period and geographic location of the safety zone for this recurring event within the Fifth Coast Guard District. This regulation applies to only one marine event listed at (d)10 in the Table to § 165.506.

The Table to § 165.506, event (d)10 establishes the enforcement date and geographic location for the “North Carolina Holiday Flotilla”. This regulation temporarily changes the enforcement date from the fourth Monday in November to Saturday, November 26, 2011 and the location to latitude 34°12′19″ N, longitude 077°48′16″ W. The temporary safety zone will be enforced from 5:30 p.m. to 8:30 p.m. on November 26, 2011, and will restrict general navigation in the regulated area during the event. The North Carolina Holiday Flotilla, which is the sponsor for this event, holds this event annually; however, they have changed the date of the event for 2011 so that it is outside the scope of the existing enforcement period. Except for participants and vessels authorized by the Coast Guard Patrol Commander, no person or vessel will be allowed to enter or remain in the regulated area. These regulations are 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 rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of that Order or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under that Order. It is not “significant” under the regulatory policies and procedures of the Department of Homeland Security (DHS).

Although this rule prevents traffic from transiting a portion of Motts Channel and Banks Channel during the specified event, the effect of this regulation will not be significant due to the limited duration that the regulated area will be in effect and the extensive advance notifications that will be made to the maritime community via marine information broadcasts, local radio stations and area newspapers so mariners can adjust their plans accordingly. Additionally, this rulemaking does not change the permanent regulated areas that have been published in 33 CFR 165.506, Table to § 165.506. In some cases vessel traffic may be able to transit the regulated area when the Coast Guard Patrol Commander deems it is safe to do so.

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

The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities. This rule would affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in Motts Channel or Banks Channel where this event is being held. This regulation will not have a significant impact on a substantial number of small entities because it will be enforced only during the event that will be patrolled by the Coast Guard patrol commander. The Captain of the Port will ensure that small entities are able to operate in the areas where events are occurring when it is safe to do so. In some cases, vessels will be able to safely transit around the regulated area at various times, and, with the permission of the Patrol Commander, vessels may transit through the regulated area. Before the enforcement period, the Coast Guard will issue maritime advisories so mariners can adjust their plans accordingly.

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

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

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

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

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

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

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

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

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

We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” under Executive Order 12866, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

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

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

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

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0093 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0093, by one of the following methods:

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

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

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

In the Federal Register of March 29, 2011 (76 FR 17374) (FRL-8867-4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP 0E7815) by Monsanto Company, 1300 I Street NW., Suite 450 East, Washington, DC 20005. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of amides, C 5 -C 9 , N-[3-(dimethylamino) propyl]; (CAS Reg. No. 1044764-00-2) and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl]; (CAS Reg. No. 1044764-06-8) when used as an inert ingredient (surfactants) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That notice referenced a summary of the petition prepared by Monsanto Company, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

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

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

Consistent with section 408(c)(2)(A) of FFDCA, and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] follows.

EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.

Acute studies revealed low oral and dermal toxicity (OPPTS Harmonized Test Guidelines 870.1100 and 870.1200). When tested on rabbits, the chemical was shown to be mildly irritating to the skin and severely irritating to the eyes (OPPTS 870.2500 and 870.2400). Skin sensitization studies in guinea pigs showed that amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] was not a skin sensitizer (OPPTS 870.2600).

Several repeat dose studies were conducted on amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] (OPPTS 870.3050 and 870.3700). A 28-day range finding study on rats showed no evidence of toxicity at doses up to 300 milligrams/kilograms/day (mg/kg/day). Systemic toxicity ( e.g., lower body weight gain, food consumption, and effects on red blood cells) were noted at 800 and 1,000 mg/kg/day. Females in the 800 mg/kg/day group also had lower organ weights of the liver, spleen, and thymus.

A second range finding study administered the test substance to female rats on gestation days 6-19. All females in the 1,000 mg/kg/day group were found dead or euthanized in extremis by gestation day 8. In the 500 mg/kg/day group, two females were euthanized in extremis. Females in this group exhibited clinical signs of toxicity ( e.g., rales, increased respiration, gasping, dilated pupils, salivation, and body weight gains). There were no test-substance related clinical findings noted up to150 mg/kg/day. Intrauterine growth and survival were unaffected at dose levels up to 500 mg/kg/day. No external malformations or developmental variations were noted in this study. The maternal and developmental NOAELs for this study were 150 and 500 mg/kg/day, respectively.

A dietary combined 90-day/Reproductive and Developmental Toxicity Screening study in rats did not show evidence of toxicity at exposures up to 175 mg/kg/day (OPPTS 870.3650/3100). At the high-dose (600 mg/kg/day), systemic toxicity was exhibited by clinical findings, lower mean body weights, body weight gains, and food consumption for males, toxicology phase females, and reproductive phase females. Lower ovary, uterus, and pituitary weights were noted for the 600 mg/kg/day reproductive phase females. In addition, lower litter size, number of pups born, implantation sites, and mean pup body weights were noted in the 600 mg/kg/day group in the presence of excessive maternal toxicity. Therefore, the systemic, reproductive, and developmental NOAELs were considered to be 175 mg/kg/day.

No carcinogenicity studies are available for the inert ingredients amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl]. The Agency used a qualitative structure activity relationship (SAR) database ( i.e., DEREK Version 11) to determine if there were structural alerts suggestive of carcinogenicity. No structural alerts were identified for the parent nor its potential major metabolite dimethylaminopropylamine (DMAPA). Based on these results and the negative findings in both the mutagenicity (OPPTS 870.5100) and clastogenicity (OPPTS 870.5395) studies along with the lack of evidence of specific target organ toxicity, the Agency concluded that these inert ingredients have low potential to be carcinogenic.

Functional observational battery (home cage, handling, open field, neuromuscular, and physiological observations) and locomotor activity (no remarkable shifts in the pattern of habituation) were recorded for Sprague-Dawley rats treated with 600 mg/kg/day of the test substance and no test-related effects were observed. Although possible evidence of neurotoxicity was observed in the OPPTS 870.3700 study at 500 mg/kg/day (dilated pupils) and 1,000 mg/kg/day (dilated pupils and clonic convulsions) these clinical signs were considered to be due to generalized toxicity and not of neurologic origin. The Point of Departure (POD) of 175 mg/kg/day used in this risk assessment is protective of the effects seen at these dose levels.

The proposed primary route of metabolism is believed to generate DMAPA which is marketed as an inert ingredient in pesticide formulations. DMAPA (as an inert) has been recently evaluated by the Agency and an exemption from tolerance under 40 CFR 180.920 and 180.930 was established.

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

The POD used in the risk assessment for short-term, intermediate-term, and chronic routes of exposure ( i.e., oral, dermal, and inhalation) was from the OPPTS Harmonized Test Guideline 870.3650 toxicity study in rats. The NOAEL is 175 mg/kg/day and the LOAEL is 600 mg/kg/day based on body weight decreases and food consumption for both sexes and lower absolute and relative-to-brain ovary, uterus, and pituitary weights for the reproductive phase females. A 100 fold uncertainty factor was used for the chronic exposure (10X interspecies extrapolation, 10X for intraspecies variability and 1X Food Quality Protection Act (FQPA) factor).

The residential, occupational, and aggregate level of concern (LOC) is for MOEs that are less than 100 and is based on 10X interspecies extrapolation, 10X for intraspecies variability and 1X FQPA factor.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl], EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] in food as follows:

The I-Dietary Exposure Evaluation Model (DEEM) is a highly conservative model with the assumption that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation between the active and inert ingredient (if any) and that the concentration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient. The model assumes 100 percent crop treated (PCT) for all crops (every food eaten by a person each day has tolerance-level residues).

2. Dietary exposure from drinking water. For the purpose of the screening level dietary risk assessment to support this request for an exemption from the requirement of a tolerance for amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl], a conservative drinking water concentration value of 100 parts per billion based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entered into the dietary exposure model.

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

These inerts may potentially be added to pesticide formulations that are used around the home ( i.e., fungicides/insecticides/herbicides). Although there are no known or anticipated residential uses for these inert ingredients, in order to be protective of any future uses, a screening level exposure assessment was performed using high-end exposure scenarios for outdoor residential uses. The Agency selected representative scenarios, based on end-use product application methods and labeled application rates.

The mixer/loader/applicator high exposure outdoor scenarios evaluated were Liquid products: Low Pressure Handwand; Liquid products: Hose End Sprayer; and Ready to Use (RTU): Trigger Pump Sprayer Applications.

The Agency believes that the handler scenarios assessed represent worse-case exposures and risks resulting from the use of outdoor pesticide products containing these inert ingredients in residential environments.

Post application high end outdoor residential exposures ( i.e., Dermal exposure to treated lawns (adults/children), Hand-to-Mouth activity for toddlers on treated lawns (children), Object-to-Mouth activity for toddlers on treated lawns (children), and Soil ingestion from treated soil (children)) were also evaluated.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] to share a common mechanism of toxicity with any other substances. Amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] may produce the metabolite DMAPA. The toxicity of this metabolite is addressed in the database. For the purposes of this tolerance action, therefore, EPA has assumed that amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] do not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. Reproductive and developmental effects were evaluated in a 90-day study conducted on Sprague-Dawley (CD) rats. No evidence of toxicity was noted at exposure levels of 15, 50, and 175 mg/kg/day. Systemic toxicity including lower mean body weights, body weight gains, and food consumption for both sexes and lower absolute and relative-to-brain ovary, uterus, and pituitary weights for the reproductive phase females was exhibited at 600 mg/kg/day. In addition, lower mean live litter size on PND 0, number of pups born and implantation sites, and lower mean pup weights were noted in the 600 mg/kg/day group. Therefore, the systemic, reproductive, and developmental NOAELs are considered to be 175 mg/kg/day. All reproductive and developmental effects were noted in the presence of excessive maternal toxicity; therefore, there was no evidence of increased susceptibility in infants and children.

In addition, an Organization for Economic Cooperation and Development (OECD) 421 reproduction and developmental toxicity screening test using the metabolite dimethylaminopropylamine in Sprague-Dawley rats resulted in parental toxicity at 200 mg/kg/day based on decreased body weight gain and clinical signs (respiratory sounds and piloerection). Reproductive and developmental toxicity were not observed at any dose level.

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

i. The toxicity database for amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] is adequate for assessing the sensitivity to infants and children.

ii. There is no indication that amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] are neurotoxic chemicals and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Although possible evidence of neurotoxicity was observed in OPPTS 870.3700 as indicated in the 500 mg/kg/day group (dilated pupils) and the 1,000 mg/kg/day group (dilated pupils and clonic convulsions), these clinical signs were considered to be due to generalized toxicity and not of neurologic origin.

iii. There is no evidence that amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] results in increased susceptibility in in utero rats.

iv. There are no residual uncertainties identified in the exposure databases. The food and drinking water assessment is not likely to underestimate exposure to any subpopulation, including those comprised of infants and children. The food exposure assessments are considered to be highly conservative as they are based on the use of the highest tolerance level from the surrogate pesticides for every food and 100 PCT is assumed for all crops. EPA also made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] in drinking water. EPA used similarly conservative assumptions to assess post application exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl].

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] are not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] from food and water will utilize 35.7 percent of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are currently no known residential uses for amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl]. Since there are no current or proposed residential uses, chronic exposure is not expected; however, inert ingredients are used in a variety of formulations and have the potential to be used in residential products. A screening level assessment was conducted for residential exposure and the risk was below the Agency level of concern.

Although there is a potential for amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] to produce the metabolite dimethylaminopropylamine (DMAPA), which is currently approved under 40 CFR 180.920 and 180.930, EPA does not anticipate any risk concerns from aggregate exposure to DMAPA for the following reasons:

i. Evidence from toxicology studies indicates that metabolization of amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl], to DMAPA does not occur in significant amounts. The parent chemicals ( i.e., amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl]) have a larger and more complete toxicity database which resulted in a higher no observed adverse effect level (NOAEL) than the metabolite, DMAPA. The POD NOAEL selected for all exposure scenarios for amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] is 175 mg/kg/day versus the NOAEL of 50 mg/kg/day for DMAPA. If DMAPA is a major metabolite of amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] then the toxicity endpoints for amides, C 5 -C 9 , N-[3-(dimethylamino)propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino)propyl] and DMAPA would be comparable.

ii. The previous risk assessment of metabolite DMAPA (as inert ingredient) indicates that any marginal increase in DMAPA exposure as a result of the use of amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] would not alter the DMAPA risk significantly nor change EPA's conclusion regarding the safety of DMAPA. [ Federal Register August 5, 2009 (74 FR 38924) (FRL-8430-2)]

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] have the potential to be used as inert ingredients in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl].

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and proposed high-end residential exposure scenarios result in aggregate MOEs greater than 100. Because EPA's level of concern for amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] have the potential to be used as inert ingredients in pesticide products that are registered for uses that could result in intermediate-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl].

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and proposed high-end residential exposure scenarios result in aggregate MOEs greater than 100. Because EPA's level of concern for amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] is a MOE of 100 or below, these MOEs are not of concern.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in various mutagenicity studies, the lack of a target organ in any of the toxicity studies conducted, and the lack of structural alerts suggestive of carcinogenicity in the structural activity database DEREK Version 11, amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] are not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl] residues.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

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 U.N. 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 amides, C 5 -C 9 , N-[3-(dimethylamino) propyl] or amides, C 6 -C 12 , N-[3-(dimethylamino) propyl].

Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180. 910 for amides, C 5 -C 9 , N-[3-(dimethylamino) propyl]; (CAS Reg. No 1044764-00-2) and amides, C 6 -C 12 , N-[3-(dimethylamino) propyl]; (CAS Reg. No. 1044764-06-8) when used as inert ingredients (surfactants) in pesticide formulations applied pre- and post-harvest.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or Tribal governments, on the relationship between the national government and the States or Tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination With Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L.104-4).

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010]-0876 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0876, by one of the following methods:

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

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

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

In the Federal Register of December 15, 2010 (75 FR 78241) (FRL-8853-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 0E7772, 0F7770, 0F7771) by Cheminova A/S, c/o Cheminova, Inc. 1600 Wilson Blvd., Arlington, VA 22209. The petitions requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide flutriafol, including its metabolites and degradates, in or on banana, whole (import tolerance) at 0.50 parts per million (ppm) (PP 0E7772). Corn, field, forage at 4.0 ppm; corn, field, stover at 6.0 ppm; corn, field, grain at 0.01 ppm; corn, field, flour at 0.03 ppm; corn, field, oil at 0.07 ppm; corn, field, meal at 0.03 ppm; corn, pop, stover at 6.0 ppm; corn, pop, grain at 0.01 ppm; grape at 1.1 ppm; grape, raisin at 2.5 ppm; peanut at 0.08 ppm; peanut, hay at 18 ppm; fruit, pome (Crop Group 11) at 0.60 ppm; fruit, stone (Crop Group 12) at 0.80 ppm; beet, sugar, root at 1.5 ppm; beet, sugar, tops at 2.5 ppm; beet, sugar, refined at 0.70 ppm; beet, sugar, molasses at 1.0 ppm; beet, sugar, dried pulp at 1.0 ppm; wheat, forage at 25 ppm; wheat, hay at 9.0 ppm; wheat, straw at 6.0 ppm; wheat, grain at 0.15 ppm; wheat, grain, bran at 0.20 ppm; wheat, grain, germ at 0.20 ppm; barley, hay at 9.0 ppm; barley, straw at 6.0 ppm; barley, grain at 0.15 ppm; barley, grain, bran at 0.20 ppm; buckwheat, grain at 0.15 ppm; oats, forage at 25 ppm; oats, hay at 9.0 ppm; oats, straw at 6.0 ppm; oats, grain at 0.15 ppm; oats, grain, bran at 0.20 ppm; rye, forage at 25 ppm; rye, straw at 6.0 ppm; rye, grain at 0.15 ppm; cattle, liver at 0.12 ppm; goat, liver at 0.12 ppm; horse, liver at 0.12 ppm; sheep, liver at 0.12 ppm; and milk at 0.02 ppm (PP 0F7771). The petition also requested that the 40 CFR part 180 be amended by establishing tolerances for the indirect or inadvertent residues of the fungicide flutriafol, including its metabolites and degradates, in or on sweet corn, field corn and cotton raw agricultural commodities (corn, sweet, forage at 0.05 ppm; corn, sweet, stover at 0.09 ppm; corn, sweet, kernels plus cob with husks removed at 0.01 ppm; corn, field, forage at 0.10 ppm; corn, field, stover at 0.07 ppm; corn, field, grain at 0.01 ppm; cotton, undelinted seed at 0.01 ppm; and cotton, gin byproducts at 0.05 ppm) grown in fields previously planted with soybeans that were treated with flutriafol (PP 0F7770). That notice referenced a summary of the petitions prepared by Cheminova A/S, c/o Cheminova, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA raised the requested tolerance levels for direct application to grape; peanut; fruit, stone, group 12-10; and rotational crop tolerances for corn, sweet, forage. EPA lowered tolerance levels for direct application to banana (import); grape, raisin; fruit, pome, group 11-09; beet, sugar; and rotational crop tolerances for corn, sweet, stover; corn, field, forage; and cotton, gin byproducts. EPA is not granting, at this time, tolerances for direct application to beet, sugar, top; peanut, hay; beet, sugar, refined; beet, sugar, molasses; beet, sugar, dried pulp; milk; corn, field, forage; corn, field, stover; corn, field, grain; corn, field, flour; corn, field, refined oil; corn, field, meal; corn, pop; corn, pop, stover; wheat, forage; wheat, hay; wheat, straw; wheat, grain; wheat, bran; wheat, germ; triticale, grain; barley, hay; barley, straw; barley, grain; barley, grain, bran; buckwheat, grain; oat, forage; oat, hay; oat, straw; oat, grain; oat, grain, bran; rye, forage; rye, straw; and rye, grain. The reasons for these changes are explained in Unit IV.C.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flutriafol including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flutriafol follows.

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

Flutriafol has high oral acute toxicity in the mouse. It has low acute toxicity via the oral, dermal and inhalation routes in rats. Flutriafol is minimally irritating to the eyes and is not a dermal irritant. Flutriafol was not shown to be a skin sensitizer when tested in guinea pigs.

Short-term, subchronic, and chronic toxicity studies in rats, mice, and dogs identified the liver as the primary target organ of flutriafol. Hepatotoxicity was first evident in the subchronic studies (rats and dogs) in the form of increases in liver enzyme release (alkaline phosphatase), liver weights, and histopathology findings ranging from hepatocyte vacuolization to centrilobular hypertrophy and slight increases in hemosiderin-laden Kupffer cells. It is noteworthy that with chronic exposures, there are no indications of progression of liver toxicity in any of the species tested. After over 1 year of exposure, hepatotoxicity in rats, dogs, and mice took the form of:

1. Minimal to severe fatty changes;

2. Bile duct proliferation/cholangiolarfibrosis;

3. Hemosiderin accumulation in Kupffer cells;

4. Centrilobular hypertrophy, and

5. Increases in alkaline phosphatase release.

Specific information on the studies received and the nature of the adverse effects caused by flutriafol as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document “Flutriafol: Human Health Risk Assessment for Proposed Uses on Corn, Grapes, Peanuts, Pome Fruit (Crop Group 11), Stone Fruit (Crop Group 12), Sugar Beets, Wheat, Barley, Triticale, Buckwheat, Oats, Rye, Teosinte and Imported Bananas” at page 40 in docket ID number EPA-HQ-OPP-2010-0876.

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

A summary of the toxicological endpoints for flutriafol used for human risk assessment is shown in the following Table.

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 those engaged in the following activities:

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

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0456 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0456, by one of the following methods:

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

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

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

In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-1), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0F7713) by Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.555 be amended by establishing tolerances for residues of the fungicide trifloxystrobin, benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3- (trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl ester), in or on alfalfa, forage at 0.01 parts per million (ppm) and alfalfa, hay at 0.01 ppm. That notice referenced a summary of the petition prepared by Bayer CropScience, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for trifloxystrobin including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with trifloxystrobin follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Trifloxystrobin exhibits very low toxicity following single oral, dermal and inhalation exposures. It is a strong dermal sensitizer. In repeated dose tests in rats, the liver is the target organ for trifloxystrobin; toxicity is induced following oral and dermal exposure for 28 days. There is no evidence of increased susceptibility following prenatal exposure to rats and rabbits and postnatal exposures to rats. Trifloxystrobin was determined not to be carcinogenic in mice or rats following long-term dietary administration. Trifloxystrobin is positive for mutagenicity in Chinese Hamster V79 cells, albeit at cytotoxic dose levels. However, trifloxystrobin is negative in the remaining mutagenicity studies.

Specific information on the studies received and the nature of the adverse effects caused by trifloxystrobin as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of June 11, 2010 (75 FR 33190) (FRL-8829-2).

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

A summary of the toxicological endpoints for trifloxystrobin used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of June 11, 2010 (75 FR 33190).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to trifloxystrobin, EPA considered exposure under the petitioned-for tolerances as well as all existing trifloxystrobin tolerances in 40 CFR 180.555. EPA assessed dietary exposures from trifloxystrobin in food as follows:

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

Such effects were identified for trifloxystrobin. In estimating acute dietary exposure for females 13-49 years old, EPA conducted an analysis using the Dietary Exposure Evaluation Model (DEEM TM 7.81), which used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998, Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). EPA used tolerance level residues. EPA assumed all commodities with established or proposed tolerances were treated with trifloxystrobin.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998, CSFII to be included in DEEM. As to residue levels in food, EPA used tolerance level residues for all commodities with the exception of apples, oranges and grapes. For these commodities EPA used anticipated residues from field residue trials. EPA assumed all commodities with established or proposed tolerances were treated with trifloxystrobin.

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

iv. Anticipated residue and percent crop treated (PCT) information. Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and information on the anticipated residue levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. For the present action, EPA will issue such Data Call-Ins as are required by FFDCA section 408(b)(2)(E) and authorized under FFDCA section 408(f)(1). Data will be required to be submitted no later than 5 years from the date of issuance of these tolerances.

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS), GENeric Estimated Exposure Concentration (GENEEC), and/or Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of trifloxystrobin plus its major degradation product, CGA-321113 for the proposed alfalfa use are less than those previously estimated in the revised EDWCs for turf use.

Acute and chronic exposures are estimated to be 47.99 parts per billion (ppb) and 47.31 ppb for surface water, respectively. Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

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

Trifloxystrobin is currently registered for the following uses that could result in residential exposures: Ornamentals and turfgrass. EPA assessed residential exposure under the following exposure scenarios: Adult post-application dermal exposure; and children's post-application dermal and/or hand to mouth exposure. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

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

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

2. Prenatal and postnatal sensitivity. There is no indication of increased susceptibility of rat or rabbits to trifloxystrobin. In the prenatal developmental study in rats, there was no developmental toxicity at the limit dose. In the prenatal developmental study in rabbits, developmental toxicity was seen at a dose that was higher than the dose that caused maternal toxicity. In the 2-generation reproduction study, there was no offspring toxicity at the highest dose tested.

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

i. The toxicity database for trifloxystrobin is complete except for neurotoxicity and immunotoxicity testing. Recent changes to 40 CFR part 158 make neurotoxicity and immunotoxicity testing required for pesticide registration; however, the existing data are sufficient for endpoint selection for exposure/risk assessment scenarios, and for evaluation of the requirements under the FQPA. Although acute and subchronic neurotoxicity and immunotoxicity studies are needed to complete the database, there are no concerns for immunotoxicity or neurotoxicity based on the results of the existing studies. The toxicological database for trifloxystrobin does not show any evidence of treatment-related effects on the immune system. There was a decrease in the incidence of hemosiderosis in the spleen of F0 and F1 parental males and females in the 2-generation reproduction study. The effect was not seen in any other toxicity studies, and it was not a primary effect on the spleen. This decrease may indicate a decrease of red blood cell turnover; but it is not an effect on the immune system. Further, there was no evidence of neurotoxicity at the limit dose in an unacceptable acute neurotoxicity study or in the other subchronic and chronic studies in the database. EPA does not believe that conducting neurotoxicity or immunotoxicity studies will result in a dose less than the points of departure already used in this risk assessment and an additional database uncertainty factor (UF) for potential neurotoxicity and/or immunotoxicity does not need to be applied.

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

iii. There is no evidence that trifloxystrobin results in increased susceptibility in in utero rats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The acute and chronic dietary food exposure assessments utilize existing and proposed tolerance level residues and 100 PCT information for all commodities, except for apples, oranges, and grapes which utilized anticipated residues for the chronic dietary assessment. By using these screening-level assessments with minor refinement, actual exposures/risks from residues in food will not be underestimated. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to trifloxystrobin in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by trifloxystrobin.

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

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. With the exception of the sub-population females 13-49 years, no adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to trifloxystrobin will occupy <2% of the aPAD for females 13-49 years old.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to trifloxystrobin from food and water will utilize 34% of the cPAD for the general U.S. population and 64% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of trifloxystrobin is not expected.

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

Trifloxystrobin is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to trifloxystrobin.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 1,100 for adults (dermal residential + dietary food and drinking water exposures); 650 for children 1-2 years (dermal residential + dietary food and drinking water exposures); and 120 for children 1-2 years (incidental oral + dietary food and drinking water exposures). Because EPA's level of concern for trifloxystrobin is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Trifloxystrobin is not expected to pose an intermediate-term risk based on a short soil half-life (approximately 2 days).

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

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

Adequate enforcement methodologies (gas chromatography with nitrogen phosphorus detection (GC/NPD), Method AG-659A and liquid chromatography with tandem mass spectrometry detection (LC/MS/MS), Method No. 200177) are available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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 U.N. 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 trifloxystrobin in or on alfalfa forage or alfalfa hay. Also, since Canada does not establish tolerances for livestock feed items, no Canadian MRLs have been established for these commodities.

Therefore, tolerances are established for residues of trifloxystrobin, benzeneacetic acid, (E,E)-α-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl) phenyl]ethylidene]amino]oxy]methyl]-methyl ester), in or on alfalfa, forage at 0.01 ppm and alfalfa, hay at 0.01 ppm.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

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

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2010-0619 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0619, by one of the following methods:

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

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

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

In the Federal Register of August 11, 2010 (75 FR 48667) (FRL-8840-6), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 0E7738) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.449 be amended by establishing tolerances for residues of the insecticide abamectin (avermectin B 1 ), a mixture of avermectins containing greater than or equal to 80% avermectin B 1a (5-O- demethyl avermectin A 1 ) and less than or equal to 20% avermectin B 1b (5-O-demethyl 25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A 1 ) and its delta-8,9-isomer, in or on bean, dry, seed at 0.01 parts per million (ppm); chive, dried leaves at 0.07 ppm; chive, fresh leaves at 0.01 ppm; and onion, bulb, subgroup 3-07A at 0.01 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Syngenta Crop Protection, Inc., the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA has revised the proposed tolerance for chive, dried leaves. Additionally, the Agency has revised the tolerance expression for all established commodities to be consistent with current Agency policy. The reasons for these changes are explained in Unit IV.C.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for abamectin (avermectin) including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with abamectin (avermectin) follows.

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

Abamectin (avermectin) has moderate to high acute toxicity by the oral route, high acute toxicity by the inhalation route, and low acute toxicity by the dermal route. It is slightly irritating to the skin, but is not an ocular irritant or a dermal sensitizer. The main target organ for abamectin (avermectin) is the nervous system. Neurotoxicity and developmental effects were detected in multiple studies and species of test animals. Signs of neurotoxicity were reported in studies of rats, mice, and dog and included decreases in foot splay reflex, mydriasis, curvature of the spine, decreased fore- and hind-limb grip strength, tip-toe gate, tremors, ataxia, or spastic movements of the limbs. Decreased body weight was also one of the most frequent findings. Severe effects, including death and morbid sacrifice, were noted in studies with rats and mice following repeated exposures.

Increased qualitative and/or quantitative susceptibility was seen in prenatal developmental toxicity studies in mice and rabbits, and the reproductive toxicity and developmental neurotoxicity studies in rats. Developmental data indicate that the most sensitive effect of abamectin (avermectin) on fetuses is the increase in the incidence of cleft palates in mice and rabbits in the presence of no or minimal maternal toxicity. No maternal or developmental toxicity was seen in the prenatal developmental toxicity study in rats.

The rat reproductive toxicity studies (two 1-generation reproduction studies and a 2-generation reproduction study) noted decreased pup body weights and/or survival at lower dose levels than those that caused parental toxicity. The developmental neurotoxicity studies in rats noted pup mortality and/or decreased body weights in the absence of maternal toxicity; there were no signs of neurotoxicity noted. In both the rat reproduction and a developmental neurotoxicity study, the data clearly indicated that the decrease in pup body weight seen at one dose level rapidly progressed to death at the next higher tested dose level. Oncogenicity and mutagenicity studies provide no indication that abamectin (avermectin) is carcinogenic or mutagenic; abamection (avermectin) has been classified as “not likely to be carcinogenic to humans.”

Specific information on the studies received and the nature of the adverse effects caused by abamectin (avermectin) as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document: “Abamectin. Human Health Risk Assessment for Proposed Uses on the Bulb Onion Subgroup 3-07A, Chives, and Dry Beans,” pp. 54-58 in docket ID number EPA-HQ-OPP-2010-0619.

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

A summary of the toxicological endpoints for abamectin (avermectin) used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to abamectin (avermectin), EPA considered exposure under the petitioned-for tolerances as well as all existing abamectin (avermectin) tolerances in 40 CFR 180.449. EPA assessed dietary exposures from abamectin (avermectin) in food as follows:

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

Such effects were identified for abamectin (avermectin). In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA utilized tolerance level residues for the proposed crops and okra and anticipated residues for the remaining commodities. Empirical processing factors and percent crop treated (PCT) data were also used, when available.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA utilized tolerance level residues for the proposed crops and okra, and average residues from field trials for the remaining crops. Empirical processing factors and PCT were also used, when available.

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

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

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

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

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

• Condition C: Data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area.

In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by FFDCA section 408(b)(2)(F), EPA may require registrants to submit data on PCT.

For the acute dietary assessment, the maximum PCT for existing uses were estimated as follows:

Almonds, 75%; apples, 10%; apricots, 5%; avocados, 60%; cantaloupes, 30%; celery, 65%; cherries, 2.5%; cotton, 20%; cucumbers, 10%; grapefruit, 80%; grapes, 25%; honeydew, 35%; lemons, 55%; lettuce, 20%; oranges, 45%; peaches, 2.5%; pears, 80%; pecans, 2.5%; peppers, 25%; potatoes, 2.5%; prunes, 10%; pumpkins, 10%; spinach, 45%; squash, 10%; strawberries, 45%; tangerines, 65%; tomatoes, 20%; walnuts, 20%; and watermelons, 10%.

For the chronic dietary assessment, the average PCT for existing uses were estimated as follows:

Almonds, 50%; apples, 5%; apricots, 5%; avocados, 40%; cantaloupes, 15%; celery, 40%; cherries, 1%; cotton, 5%; cucumbers, 5%; grapefruit, 60%; grapes, 10%; honeydew, 20%; lemons, 35%; lettuce, 10%; oranges, 25%; peaches, 1%; pears, 70%; pecans, 1%; peppers, 10%; potatoes, 1%; prunes, 2.5%; pumpkins, 2.5%; spinach, 20%; squash, 5%; strawberries, 30%; tangerines, 60%; tomatoes, 10%; walnuts, 10%; and watermelons, 5%.

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

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

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

Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of abamectin (avermectin) for acute exposures are estimated to be 2.3 parts per billion (ppb) for surface water and 1.6 × 10 − 3 ppb for ground water, and for chronic exposures for non-cancer assessments are estimated to be 1.3 ppb for surface water and 1.6 × 10 − 3 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For acute dietary risk assessment, the water concentration value of 2.3 ppb was used to assess the contribution to drinking water. For chronic dietary risk assessment, the water concentration of value 1.3 ppb was used to assess the contribution to drinking water.

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

Abamectin (avermectin) is currently registered for the following uses that could result in residential handler and postapplication exposures: Granular baits used to treat lawns and indoor crack and crevice dust products. EPA assessed residential exposure using the following assumptions: Adults were assessed for short- and intermediate-term residential handler and postapplication exposures (dermal and inhalation). Children were assessed for short- and intermediate-term postapplication dermal, inhalation, and incidental ingestion exposures (hand-to-mouth and object-to-mouth). Recreational exposures to turf are expected to be similar to, or less than, those described above, and were therefore not assessed. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found abamectin (avermectin) to share a common mechanism of toxicity with any other substances, and abamectin (avermectin) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that abamectin (avermectin) does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

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

2. Prenatal and postnatal sensitivity. The abamectin (avermectin) toxicity database is adequate to evaluate potential increased susceptibility of infants and children, and includes developmental toxicity studies in rat, mice, and rabbits; two 1-generation rat reproductive toxicity studies in rat; a 2-generation reproductive toxicity study in rat; and two developmental neurotoxicity studies in rat. No developmental effects were seen in the rat developmental toxicity study. However, increased quantitative susceptibility was noted in the prenatal developmental toxicity studies in mice and rabbits, the rat reproductive toxicity studies, and the developmental neurotoxicity studies in rat.

3. Conclusion. In previous abamectin (avermectin) risk assessments, the 10x FQPA safety factor was retained as a database uncertainty factor for the lack of a developmental neurotoxicity study. Two developmental neurotoxicity studies have now been submitted and reviewed and the findings in these studies were considered in the identification of toxicological points of departure and uncertainty/safety factors.

EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X for the acute dietary assessment and 3X for all assessments other than acute dietary. That decision is based on the following findings:

i. For all risk assessments involving repeated exposures to abamectin (avermectin), EPA determined that a 3x safety factor would be appropriate, based on the severity of effects (decrease in pup body weight and mortality) and the steepness of the dose-response curve seen in the developmental neurotoxicity study and three reproductive toxicity studies in the rat. These studies have documented a very narrow dose range from NOAEL (0.12 mg/kg/day) to adverse effect (0.2 mg/kg/day) to severe adverse effect (0.4 mg/kg/day). Dose spacing is commonly greater than 2x between NOAEL and LOAEL, and the 3x difference between the NOAEL and the dose that induced mortality in the pups in the developmental neurotoxicity study provides little margin of safety for the severity of the effects seen.

Retaining an additional 3x FQPA safety factor effectively provides a 10x margin between the dose which causes death (0.4 mg/kg/day) and the NOAEL adjusted by the additional safety factor (0.12 mg/kg/day/3x = 0.04 mg/kg/day). A dose spacing of 10x between a NOAEL and LOAEL is as broad, if not broader, than the dose spacing generally used in animal testing and thus removes the residual concern of the steepness of the dose-response curve and the severe effects noted.

Additionally, this adjusted point of departure (0.04 mg/kg/day) would address the concerns for the increased susceptibility seen at higher doses in the 2-generation reproduction study in rats (LOAEL = 0.4 mg/kg/day), prenatal developmental study in mice (LOAEL = 0.75 mg/kg/day), the prenatal developmental toxicity study in rabbits (LOAEL = 2 mg/kg/day), and the 1-generation rat reproduction study (LOAEL = 0.2 mg/kg/day).

With respect to acute dietary exposure, the endpoint selected for risk assessment is based on mydriasis observed in dogs. The EPA determined that the additional 3x factor applied to chronic and other exposure scenarios is not applicable to acute exposure for the following reasons:

a. The concerns noted for steepness of the dose-response curve and the severity of effects were not seen in the studies where mydriasis occurred.

b. The reduced body weights noted in studies following repeated exposure to abamectin (avermectin) are not a single dose effect.

c. The increased susceptibility seen in the prenatal developmental toxicity studies, reproductive toxicity studies, and the developmental neurotoxicity studies were seen at a dose lower (LOAEL 0.2 mg/kg/day) than the dose (LOAEL 1.0 mg/kg/day) that caused mydriasis.

Therefore, EPA has determined that it would be appropriate if the FQPA SF were reduced to 1X for the acute dietary assessment.

ii. The toxicity database for abamectin (avermectin) is complete, except for immunotoxicity testing. Recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing (OPPTS Guideline 870.7800) for pesticide registration. However, the toxicity database for abamectin (avermectin) provides no indication of immunotoxicity and abamectin (avermectin) does not belong to a class of chemicals that would be expected to be immunotoxic. EPA does not believe that conducting an immunotoxicity study will result in a NOAEL less than the NOAELs of 0.5 mg/kg/day and 0.12 mg/kg/day already set for abamectin (avermectin) acute and repeated exposures, respectively, and an additional uncertainty factor is not needed to account for potential immunotoxicity.

iii. Signs of neurotoxicity ranging from decrease in foot splay reflex, mydriasis ( i.e., excessive dilation of the pupil), curvature of the spine, decreased fore- and hind-limb grip strength, tip-toe gate, tremors, ataxia, or spastic movements of the limbs were reported in various studies with different durations of abamectin (avermectin) exposure in rats, mice, and dogs. However, the results of two submitted rat developmental neurotoxicity studies did not show any evidence of neurotoxicity.

iv. There are no residual uncertainties identified in the exposure databases. The acute and chronic dietary exposure assessments were refined and utilized tolerance level or anticipated residues, default or empirical processing factors, and PCT estimates. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to abamectin (avermectin) in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by abamectin (avermectin).

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

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to abamectin (avermectin) will occupy 30% of the aPAD for infants less than 1 year old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to abamectin (avermectin) from food and water will utilize 50% of the cPAD for children 1-2 years old the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of abamectin (avermectin) is not expected.

3. Short- and intermediate-term risk. Short- and intermediate-term aggregate exposure takes into account short- and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Abamectin (avermectin) is currently registered for uses that could result in short- and intermediate-term residential exposures, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short- and intermediate-term residential exposures to abamectin (avermectin).

Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in aggregate MOEs of 1200 for the general population and 500 for children 1-2 years old. Because EPA's level of concern for abamectin (avermectin) is a MOE of 300 or below, these MOEs are not of concern.

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

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

Adequate enforcement methodologies are available in Pesticide Analytical Manual II (PAM II) for citrus and processed fractions (Method I), ginned cottonseed (Method IA), and bovine tissues and milk (Method II). Additionally, Method M-073 and M-936-95-2 have been validated by the Agency and submitted for inclusion in PAM II as enforcement methods. These five methods are adequate for enforcement of the tolerances on plants and livestock.

Method M-073 and M-936-95-2 may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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 U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

There are currently no Codex MRLs for abamectin (avermectin) on commodities associated with this petition.

Based upon review of the data supporting the petition, EPA revised the proposed tolerance for chive, dried leaves from 0.07 ppm to 0.02 ppm. EPA revised the tolerance level based on analysis of the residue field trial data using the Agency's Tolerance Spreadsheet in accordance with the Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial Data. Additionally, the Agency has revised the tolerance expression to clarify:

1. That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of abamectin (avermectin) not specifically mentioned; and

2. That compliance with the specified tolerance levels is to be determined by measuring only the specific compounds mentioned in the tolerance expression.

Therefore, tolerances are established for residues of abamectin (avermectin), avermectin B 1 [a mixture of avermectins containing greater than or equal to 80% avermectin B 1a (5- O -demethyl avermectin A 1 ) and less than or equal to 20% avermectin B 1b (5- O -demethyl-25-de(1-methylpropyl)-25-(1-methylethyl) avermectin A 1 )] and its delta-8,9-isomer, in or on onion, bulb, subgroup 3-07A at 0.01 ppm; chive, fresh leaves at 0.01 ppm; chive, dried leaves at 0.02 ppm; and bean, dry, seed at 0.01 ppm. This regulation additionally removes the time-limited tolerances on bean, lima, seed at 0.005 ppm; and onion, bulb at 0.005 ppm, as they will be superseded by permanent tolerances.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

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

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

Therefore, 40 CFR chapter I is amended as follows:

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

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0583 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0583, by one of the following methods.

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

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

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

In the Federal Register of Friday, August 26, 2011 (76 FR 53372) (FRL-8884-9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 1E7875) filed by Akzo Nobel Surface Chemistry LLC, 909 Mueller Avenue, Chattanooga, TN 37406. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer; CAS Reg. No. 111740-36-4. That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments.

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

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW of 1,884 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW1,000, and the polymer does not contain any reactive functional groups.

Thus, methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer.

For the purposes of assessing potential exposure under this exemption, EPA considered that methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer is 1,884 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

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

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. 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 U.N. 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 methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer.

Accordingly, EPA finds that exempting residues of methacrylic acid-methyl methacrylate-polyethylene glycol monomethyl ether methacrylate graft copolymer from the requirement of a tolerance will be safe.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes, or otherwise have any unique impacts on local governments. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

Although this action does not require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population.

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

Therefore, 40 CFR chapter I is amended as follows:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2011-0333 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 9, 2012. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0333, by one of the following methods.

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

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

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

In the Federal Register of July 6, 2011 (79 FR 39358) (FRL-8875-6), EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP 1E7835) filed by AkzoNobel Surface Chemistry LLC, 909 Mueller Ave., Chattanooga, TN 37406. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of methacrylic acid sodium salt (CAS No. 1260001-65-7). This tolerance exemption uses the common chemical name methacrylic polymer, also known as 2-Propenoic acid, 2-methyl-, telomer with 2-ethylhexyl 2-propenoate, 2-propanol and sodium 2-methyl-2-[(1-oxo-2-propen-1-yl) amino]-1-propanesulfonate (1:1), sodium salt; CAS Reg. No. 1260001-65-7. That notice included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency received 2 comments from private citizens who opposed the authorization to sell any pesticide that leaves a residue on food. The Agency understands the commenter's concerns and recognizes that some individuals believe that no residue of pesticides should be allowed. However, under the existing legal framework provided by section 408 of FFDCA, EPA is authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by the statute.

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

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

Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Methacrylic polymer conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers.

1. The polymer is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment.

2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen.

3. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii).

4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize.

5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption.

6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons.

Additionally, the polymer also meets as required the following exemption criteria specified in 40 CFR 723.250(e).

7. The polymer's number average MW of 2,900 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups (See 40 CFR 723.250(e) for more information on reactive functional groups).

Thus, methacrylic polymer meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to methacrylic polymer.

For the purposes of assessing potential exposure under this exemption, EPA considered that methacrylic polymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of methacrylic polymer is 2,900 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since methacrylic polymer conform to the criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

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

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of methacrylic polymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

Based on the conformance to the criteria used to identify a low-risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of methacrylic polymer.

There are currently no existing exemptions from a tolerance for methacrylic polymer.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. 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 U.N. 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 methacrylic polymer.

Accordingly, EPA finds that exempting residues of methacrylic polymer from the requirement of a tolerance will be safe.

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

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

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes, or otherwise have any unique impacts on local governments. Thus, the Agency has determined that Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4).

Although this action does not require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994), EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. As such, to the extent that information is publicly available or was submitted in comments to EPA, the Agency considered whether groups or segments of the population, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticide discussed in this document, compared to the general population.

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

Therefore, 40 CFR chapter I is amended as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

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

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

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

Accordingly, 44 CFR part 67 is amended as follows: