Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on January 13, 2011 (76 FR 2279). That NPRM proposed to correct an unsafe condition for the specified products. MCAI Brazilian Airworthiness Directive 2009-11-01 states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

Goodrich requested that issuance of this AD be delayed until further notice pending completion of their ongoing investigations into the root cause of additional door stall events. The commenter anticipates that a reduced overhaul cycle might be required to mitigate future occurrences until a complete and final action is developed.

We disagree with the request to delay the AD. To delay this action would be inappropriate, in light of the identified unsafe condition. We might consider additional rulemaking action, however, if we receive new information indicating the need to change the AD. We have not changed the AD in this regard.

EMBRAER requested that post-modification part number (P/N) 4A4030-5 for the ERJ 170, and P/N 104003-2 for the ERJ 190, be included in the Applicability, Actions, and Parts Installation paragraphs of the NPRM (paragraphs (c), (g), and (i) respectively). The commenter made this request in response to reports of door stall caused by the forward escape slide of those part numbers post-modification using the version of the Goodrich service information cited in the NPRM.

We disagree with the request to add the part numbers. While we are aware of the reports of door stall caused by the forward escape slides with those other parts that had been modified per the Goodrich service information cited in the NPRM, we understand that the root cause of the door stall is still under investigation, as mentioned by the previous commenter. Further, we choose to not delay issuance of the AD as mentioned previously, because the known unsafe condition exists on the part numbers specified in the NPRM. When that investigation is complete we might take further rulemaking action. We have not changed the AD in this regard.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD as proposed.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect about 236 products of U.S. registry. We also estimate that it will take about 12 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $0 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $240,720, or $1,020 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on March 14, 2011 (76 FR 13539). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comments received.

JetBlue requested that, in addition to replacement of the pylon rear inboard and outboard internal shear pins, a detailed visual inspection of the pylon rear outboard and inboard external shear pins should be done to ensure that the external shear pins have no evidence of corrosion and corrosion products, or corrosion pitting. JetBlue found external shear pins with surface corrosion and pitting.

We disagree with the request. Embraer inspected the suspect external shear pins from JetBlue and found particles of sealant and other contaminants embedded in the inner surface, but there was no sign of corrosion or damage. The material of the external shear pin is corrosion-resistant stainless steel. No change has been made to the AD in this regard.

Embraer requested that paragraph (j) of the NPRM refer to EMBRAER Service Bulletin 190LIN-54-0001, dated June 21, 2010, rather than 190LIN-54-001.

We agree with the request and have made the change in paragraph (j) of this AD.

We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting the AD with the change described previously. We determined that this change will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 73 products of U.S. registry. We also estimate that it will take about 10 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $2,360 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $234,330, or $3,210 per product.

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on May 12, 2011 (76 FR 27617). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 27617, May 12, 2011) or on the determination of the cost to the public.

Bombardier Service Bulletin 84-27-50, Revision ‘D,' dated September 22, 2010, has been issued for clarification, but adds no new actions. We have updated the references in paragraphs (g), (h), (i), and (m) of this AD to include Bombardier Service Bulletin 84-27-50, Revision ‘D,' dated September 22, 2010. We have also updated Table 1 of this AD to allow credit for Bombardier Service Bulletin 84-27-50, Revision ‘C,' dated July 26, 2010.

We reviewed the relevant data, and determined that air safety and the public interest require adopting the AD with the changes described previously. We also determined that these changes will not increase the economic burden on any operator or increase the scope of the AD.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have required different actions in this AD from those in the MCAI in order to follow our FAA policies. Any such differences are highlighted in a NOTE within the AD.

We estimate that this AD will affect 66 products of U.S. registry. We also estimate the following costs to comply with this AD.

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

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

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

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

For the reasons discussed above, I certify this AD:

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

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

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

We prepared a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM, the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Form ID is filed by registrants, third party filers, or any of their respective agents, to whom the Commission previously has not assigned a Central Index Key (“CIK”) code, to request access codes in order to file in electronic format through EDGAR. EDGAR access codes include the CIK code, the CIK Confirmation Code (“CCC”), Password (“PW”), and Password Modification Authorization Code (“PMAC”). 1

Currently, Form ID does not differentiate applicants by specific type and simply lists as possible applicant types “filer,” “filing agent,” “training agent,” “transfer agent,” and “individual.” However, the number and type of persons that use EDGAR for submitting filings has increased since Form ID was first adopted by the Commission and may increase further following the adoption of various rules under the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”). 2 Accordingly, the Commission is amending Form ID to list specific persons as applicant types on the form in order to allow the form to be assigned for processing within the Commission based on the type of applicant.

The new applicant types include persons that currently file on EDGAR but who are not separately listed on Form ID, persons that currently file forms with the Commission in paper but who may be required to file on EDGAR in the future, and persons who will be required to meet certain new filing obligations under the Securities Exchange Act of 1934 (“Exchange Act”), including provisions added by the Dodd-Frank Act. The amendments to Form ID also include corresponding definitions for each new applicant type. 3 New applicants should select only one entity type when completing and submitting Form ID. 4 If an applicant qualifies as more than one of the applicant types listed on the form, it should select the applicant type related to the first filing it plans to submit on EDGAR. The access codes the applicant retrieves after Form ID is approved may be used to submit filings on EDGAR for any entity type (other than transfer agent) provided that such filing complies with all other applicable rules and regulations. 5 Persons that have previously filed Form ID applications with the Commission are not required to re-file Form ID as a result of these amendments.

As more fully described below, the following applicant types and applicable definitions are being added to Form ID: Investment Company, Business Development Company or Insurance Company Separate Account, Institutional Investment Manager (Form 13F Filer), Non-Investment Company Applicant under the Investment Company Act of 1940, Large Trader, Clearing Agency, Municipal Advisor, Municipal Securities Dealer, Nationally Recognized Statistical Rating Organization, Security-Based Swap Data Repository, Security-Based Swap Dealer and Major Security-Based Swap Participant, and Security-Based Swap Execution Facility.

Currently, a person that may fall within the applicant type of “Investment Company, Business Development Company or Insurance Company Separate Account,” “Institutional Investment Manager (Form 13F Filer),” or “Non-Investment Company Applicant under the Investment Company Act of 1940” may make submissions on EDGAR in electronic format without referencing the appropriate applicant type on Form ID. As such, the Commission is adding these specific applicant types to Form ID in order to facilitate processing of the form as filed by such persons. The applicant type of “Investment Company, Business Development Company or Insurance Company Separate Account” being added to Form ID includes persons that meet the definition of “investment company” in Section 3 of the Investment Company Act of 1940 (“Investment Company Act”)  6 or otherwise register an offering of their securities on a registration form adopted by the Commission under the Investment Company Act, including management companies (within the meaning of Sections 4 and 5 of the Investment Company Act), face-amount certificate companies (within the meaning of Section 2(a)(15) of the Investment Company Act), unit investment trusts (within the meaning of Section 4 of the Investment Company Act), business development companies (within the meaning of Section 2(a)(48) of the Investment Company Act), and insurance company separate accounts (including any separate account which would be required to be registered under the Investment Company Act except for the exclusion provided by Section 3(c)(11) of such Act and which files a registration statement on Form N-3 or Form N-4). The applicant type of “Institutional Investment Manager (Form 13F Filer)” includes any person that is required to file a Form 13F under Section 13(f) of the Exchange Act and the rules promulgated thereunder. 7 Finally, a “Non-Investment Company Applicant under the Investment Company Act of 1940” is descriptive of the type of Form ID applicant that is submitting an application seeking an order from the Commission for an exemption from one or more provisions of the Investment Company Act and the rules promulgated thereunder.

The applicant type “Large Trader” is being added to Form ID in order for these new registrants to retrieve EDGAR access codes and subsequently register with the Commission as a large trader in accordance with new Rule 13h-1 under the Exchange Act, which will become effective as of October 3, 2011. 8 The definition of “Large Trader” that is being added to Form ID cross-references the definition that was adopted by the Commission in Rule 13h-1.

Among other things, Title VII of the Dodd-Frank Act added new provisions to the Exchange Act that require clearing agencies that clear security-based swaps to register with the Commission. It also required that the Commission adopt rules with respect to security-based swap clearing agencies. 9 The Commission previously stated that it preliminarily believes that clearing agencies should in the future file compliance reports with the Commission in a tagged data format in accordance with the EDGAR database, which would utilize the existing EDGAR framework to provide electronic filings to the Commission. 10 The definition of “Clearing Agency” being added to Form ID cross-references the definition in Section 3(a)(23) of the Exchange Act. 11

Section 975 of the Dodd-Frank Act amended Section 15B of the Exchange Act to make it unlawful for “a municipal advisor to provide advice to or on behalf of a municipal entity or obligated person with respect to municipal financial products or the issuance of municipal securities, or to undertake a solicitation of a municipal entity or obligated person, unless the municipal advisor is registered.”  12 Municipal Advisors register with the Commission on Form MA-T. 13 This current form is temporary, however, with an expiration date of December 31, 2011. 14 On December 20, 2010, the Commission proposed rules relating to a permanent registration regime for municipal advisors. 15 The proposed permanent registration regime would require that an application for the registration of a municipal advisor must be filed electronically with the Commission on proposed new Forms MA or MA-I, as applicable, and the Commission is considering whether such applications should be filed through EDGAR. 16 The definition of “Municipal Advisor” on Form ID cross-references the definition in Section 15B(e)(4) of the Exchange Act. 17

A “Municipal Securities Dealer” currently registers with the Commission in paper format on Form MSD. 18 The definition of “Municipal Securities Dealer” being added to Form ID cross-references the definition in Section 3(a)(30) of the Exchange Act. 19

A Nationally Recognized Statistical Rating Organization (“NRSRO”) currently registers with the Commission in paper format on Form NRSRO  20 and files annual reports required under Rule 17g-3 of the Exchange Act. 21 The Commission has proposed amending these rules to require an NRSRO to use EDGAR in order to submit all future information and reports. 22 The definition of a “Nationally Recognized Statistical Rating Organization” that is being added to Form ID cross-references the definition in Section 3(a)(62) of the Exchange Act. 23

The Dodd-Frank Act provided the Commission with broad authority to adopt rules governing security-based swap data repositories (“SDRs”) and to develop additional duties applicable to these SDRs. The Commission proposed Rule 13n-1 under the Exchange Act to establish the procedures by which SDRs could apply to the Commission for registration. 24 This proposed rule provided that an application for the registration of an SDR must be filed electronically on proposed new Form SDR with the Commission. The definition of “Security-Based Swap Data Repository” being added to Form ID cross-references the definition in Section 3(a)(75) of the Exchange Act. 25

Section 761(a) of the Dodd-Frank Act amended Section 3(a) of the Exchange Act to add definitions for, among others, the terms “security-based swap dealer” and “major security-based swap participant.”  26 Section 15F of the Exchange Act, added by section 764(a) of the Dodd-Frank Act, establishes requirements for registration and comprehensive oversight of security-based swap dealers and major security- based swap participants. 27 The definition of “Major Security-Based Swap Participant” that is being added to Form ID cross-references the definition in Section 3(a)(67)(A) of the Exchange Act. 28 In addition, the definition of “Security-Based Swap Dealer” that is being added to Form ID cross-references the definition in Section 3(a)(71)(A) of the Exchange Act. 29

Section 761(a) of the Dodd-Frank Act amended Section 3(a) of the Exchange Act to add definitions for, among others, the term “security-based swap execution facility.”  30 In accordance with Section 763 of the Dodd-Frank Act, the Commission proposed Regulation SB SEF under the Exchange Act, which was designed to create a registration framework for security-based swap execution facilities (“SB SEFs”). 31 Proposed rule 801(a) in Regulation SB SEF would require the registration application for SB SEFs to be filed electronically in a tagged data format with the Commission on Form SB SEF. 32 The definition of a “Securities-Based Swap Execution Facility” that is being added to Form ID cross-references the definition found in Section 3(a)(77) of the Exchange Act. 33

The Commission believes that updating Form ID to add the above applicant types and related definitions will facilitate the processing of the form, including by routing Form ID filings to the appropriate internal office or division, and allow filers to promptly retrieve access codes and file in electronic format on EDGAR.

The Administrative Procedure Act (“APA”)  34 generally requires an agency to publish, before adopting a rule, notice of a proposed rulemaking in the Federal Register . 35 This requirement does not apply, however, to, “interpretive rules, general statements of policy, or rules of agency organization, procedure, or practice.”  36 Further, the APA also generally requires that an agency publish a rule in the Federal Register 30 days before the rule becomes effective. 37 This requirement, however does not apply where an agency finds good cause. 38

The Commission is amending Form ID to include new applicant types. These new applicant types are “Investment Company, Business Development Company or Insurance Company Separate Account,” “Institutional Investment Manager (13F Filer),” “Non-Investment Company Applicant under the Investment Company Act of 1940,” “Large Trader,” “Clearing Agency,” “Municipal Advisor,” “Municipal Securities Dealer,” “Nationally Recognized Statistical Rating Organization,” “Security-Based Swap Data Repository,” “Security-Based Swap Dealer and Major Security-Based Swap Participant,” and “Securities-Based Swap Execution Facility.” The sole purpose of including these new applicant types is to improve the Commission's internal procedures for processing filings, including routing Form ID filings to the appropriate internal office or division. Accordingly, the Commission finds that because the amendments relate solely to rules of agency organization, procedure or practice, publishing the changes for comment is unnecessary. 39

The APA also generally requires publication of a rule in the Federal Register at least 30 days before its effective date unless the agency finds otherwise for good cause. 40 As noted above, the amendments to Form ID are intended solely to improve the Commission's internal procedures for processing filings. These changes will not impose a new burden on any person to file the form with the Commission as the obligation to submit a Form ID arises from the requirement to make filings with the Commission through EDGAR in accordance with other rules and regulations issued by the Commission. Similarly, the amendments do not impose any burden on persons who have previously submitted a Form ID as these persons will not be required to re-file the Form ID to account for the inclusion of specific applicant types. These changes will allow the Commission to process Form IDs more efficiently and will reduce the likelihood of unnecessary delays in processing. For these reasons, the Commission finds good cause for these procedural amendments to take effect immediately.

Form ID, as in effect prior to these amendments, contains “collection of information” requirements within the meaning of the Paperwork Reduction Act of 1995 (“PRA”). 41 Specifically, there is a current approved collection of information for Form ID entitled “EDGAR Form ID” (Office of Management and Budget (“OMB”) Control No. 3235-0328). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

We do not believe that the amendments to Form ID necessitate an increase or decrease in the current PRA burden estimates for Form ID. Specifically, respondents to Form ID previously were required to indicate whether they are submitting the form as a “filer,” “filing agent,” “training agent,” “transfer agent,” or “individual.” The amendments we are adopting today simply add new applicant types to reflect persons that currently file on EDGAR but who are not separately listed on Form ID. These new applicant types include “Investment Company, Business Development Company or Insurance Company Separate Account,” “Institutional Investment Manager (Form 13F Filer),” “Non-Investment Company Applicant under the Investment Company Act of 1940,” “Large Trader,” “Clearing Agency,” “Municipal Advisor,” “Municipal Securities Dealer,” “Nationally Recognized Statistical Rating Organization,” “Security-Based Swap Data Repository,” “Security-Based Swap Dealer and Major Security-Based Swap Participant,” and “Securities-Based Swap Execution Facility.” Respondents will continue to be required to select an appropriate applicant type, with the sole difference being that that the list of options will increase.

The amendments to Form ID do not impose a new burden on any person to file the form with the Commission, nor do they impose any burden on persons who have previously submitted a Form ID as these persons will not be required to re-file the Form ID to account for the inclusion of specific applicant types. The sole change being effected by these amendments will be that new registrants will be asked to indicate a specific applicant type when completing the Form ID. To the extent that these new registrants will be required to register with the Commission and make filings on EDGAR in accordance with other Commission rules and regulations, the PRA burdens associated with those obligations will be accounted for in the context of those other rules and regulations.

The total estimated burden of filing a Form ID for a filer not currently subject to a requirement to file on EDGAR is 0.15 hours. For the reasons discussed above, we therefore believe that the overall information collection burden of Form ID would remain the same. As a result, we have not submitted the revisions to the collection of information to the Office of Management and Budget for review under 44 U.S.C. 3507(d) and 5 CFR 1320.11.

The amendments to Form ID update the form to reflect the increased use of the EDGAR database by various persons and institutions regulated by the Commission. Some of these entities currently file on EDGAR in electronic format and others may be required to file on EDGAR in the future. The amendments will facilitate the Commission's process for reviewing and processing the form and, consequently, the ability of filers to promptly retrieve the access codes needed to file on EDGAR. We do not believe these amendments will impose any significant costs on non-agency parties.

Section 23(a)  42 of the Exchange Act requires the Commission, when making rules and regulations under the Exchange Act, to consider the impact a new rule would have on competition. Section 23(a)(2) of the Exchange Act prohibits the Commission from adopting any rule that would impose a burden on competition not necessary or appropriate in furtherance of the purposes of the Exchange Act. Section 3(f) of the Exchange Act  43 and Section 2(c) of the Investment Company Act  44 require the Commission, when engaging in rulemaking that requires it to consider whether an action is necessary or appropriate in the public interest, to consider, in addition to the protection of investors, whether the action would promote efficiency, competition, and capital formation. We do not believe that the amendments to Form ID that reflect new entity applicant types will have any impact on competition.

We are adopting the amendments to Form ID under the authority in Section 19(a)  45 of the Securities Act, Sections 3(b), 46 13(a), 47 23(a), 48 and 35A  49 of the Exchange Act, Section 319  50 of the Trust Indenture Act of 1939 and Sections 30  51 and 38  52 of the Investment Company Act of 1940.

For the reasons set out in the preamble, the Commission amends title 17, chapter II, of the Code of Federal Regulations as follows.

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

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

Competitor Group is sponsoring the TriRock Triathlon, consisting of 2000 swimmers swimming a predetermined course. The sponsor will provide three safety vessels for this event. This safety zone is necessary to provide for the safety of the participants, crew, spectators, sponsor vessels, and other users of the waterway.

The Coast Guard is establishing a safety zone that will be enforced on September 11, 2011, from 7 a.m. to 10 a.m. The limits of the safety zone will be navigable waters of the San Diego Bay behind the San Diego Convention Center bound by the following coordinates including the marina; 32°42′16″ N, 117°09′58″ W to 32°42′15″ N, 117°10′02″ W then south to 32°42′00″ N, 117°09′45″ W to 32°42′03″ N, 117°09′40″ W.

This temporary safety zone is necessary to ensure unauthorized personnel and vessels remain safe by keeping clear during the bay swim. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port, or his designated representative.

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

This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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 Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under that those Orders.

This determination is based on the size and location of the temporary safety zone. Commercial vessels will not be hindered by the safety zone. Recreational vessels may be allowed to transit through the designated safety zone during the specified times if they request and obtain authorization from the Captain of the Port, or designated representative.

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

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

This rule will affect the following entities, some of which may be small entities: The owners or operators of vessels intending to transit or anchor in the aforementioned portion of the San Diego Bay from September 11, 2011, from 7 a.m. to 10 a.m.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In a final rule with comment period published in the Federal Register on August 25, 2011, the Postal Service provided new maximum limits for mailpieces containing equipment with lithium metal or lithium-ion batteries that were to be effective October 3, 2011. These revisions were consistent with recent amendments to the Universal Postal Union (UPU) Convention and regulations as announced in International Bureau Circulars 114 and 115, dated June 14, 2011, that affected UPU Convention Articles 15 and 16, Article RL 131 of the letter post regulations, and Article RC 120 of the parcel post regulations.

The withdrawal of the revisions is necessary because of a notice to the UPU from the International Civil Aviation Organization (ICAO) on August 19, 2011, requesting that the UPU delay implementation of the aforementioned amendment until the UPU revisions could be reviewed by the ICAO Dangerous Goods Panel, and if approved, incorporated into The Technical Instructions for the Safe Transport of Dangerous Goods by Air manual. Therefore, the UPU has informed its member countries that the date of newly adopted UPU amendments for lithium batteries will be the subject of further notice based on the decision of the panel and any changes to the ICAO Technical Instructions.

Accordingly, the Postal Service withdraws its final rule published on August 25, 2011. The Postal Service also withdraws the revision to 39 CFR 20.1 whereby a new section 135.6 was added to the Mailing Standards of the United States Postal Service, International Mail Manual (IMM®) to describe the new maximum limits for the outbound mailing of lithium batteries to international, or APO, FPO or DPO locations. The parallel changes that were to be made to other USPS publications are also withdrawn.

The EPA issued a PSD permit on May 27, 2011, to Avenal Power Center, LLC for the Avenal Energy Project, granting approval to construct a new 600-megawatt natural gas-fired combined-cycle power plant in Kings County, California. The EPA issued an administrative amendment to the permit on June 21, 2011, to correct typographical errors. The EPA's Environmental Appeals Board (EAB) received four petitions for review of the permit from the following entities within 30 days of the EPA's service of notice of the issuance of the permit: (1) El Pueblo Para El Aire y Agua Limpio; (2) Greenaction for Health & Environmental Justice; (3) Sierra Club and Center for Biological Diversity; and (4) Mr. Rob Simpson. The EAB denied review of these petitions on August 18, 2011. All conditions of the Avenal Power Center, LLC permit for the Avenal Energy Project, as amended on June 21, 2011, are final and effective. Pursuant to 40 CFR 124.19(f)(1), final agency action by EPA has occurred because of the exhaustion of the agency review procedures before the EAB. The EPA Administrator has delegated authority to the EAB to issue final decisions in PSD permit appeals filed under 40 CFR part 124. 40 CFR 124.2(a).

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 section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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-2011-0639 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 November 8, 2011. 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-2011-0639, 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for residues of mandipropamid, 4-chloro- N -[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-(2-propynyloxy)-benzeneacetamide, in or on basil, fresh at 20 parts per million (ppm) and basil, dried at 240 ppm. These time-limited tolerances expire on December 31, 2012.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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 * * *.”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

The Applicant stated that a new, destructive fungal pathogen, known as downy mildew ( Peronospora belbahrii ), has been identified in Illinois and it resulted in a 50% yield loss in basil production using registered alternatives. Illinois recently experienced some atypical weather conditions (high moisture and temperatures) that were conducive to the development and spread of the disease. The increase presence of the disease and the zero tolerance policy for downy mildew adopted by the distributors led basil grower to seek a spray program to maintain season-long control of this disease. The registered alternatives have been deemed inadequate for season-long control due to product application restrictions or lack of product efficacy. The Applicant stated that because of the favorable weather conditions and the inadequacy of the registered alternatives to achieve season-long control of the downy mildew, an emergency situation exists and significant economic losses will likely incur. Further, the Applicant asserts that without a suitable additional fungicide, such as mandipropamid, to address the issue, the future viability of basil industry in Illinois is threatened. After having reviewed the submission, EPA determined that an emergency condition exists for this State, and that the criteria for approval of an emergency exemption are met. EPA has authorized a specific exemption under FIFRA section 18 for the use of mandipropamid on basil for control of downy mildew in Illinois.

As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of mandipropamid in or on basil, fresh and basil, dried. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although these time-limited tolerances expire on December 31, 2012, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on basil, fresh and basil, dried after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by these time-limited tolerances at the time of that application. EPA will take action to revoke these time-limited tolerances earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because these time-limited tolerances are being approved under emergency conditions, EPA has not made any decisions about whether mandipropamid meets FIFRA's registration requirements for use on basil or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of mandipropamid by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Illinois to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for mandipropamid, contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT .

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 the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption request and the time-limited tolerances for residues of mandipropamid on basil, fresh at 20 ppm and basil, dried at 240 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.

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 mandipropamid used for human risk assessment is discussed in Unit III. of the final rule published in the Federal Register of January 16, 2008 (73 FR 2812) (FRL-8346-6).

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to mandipropamid, EPA considered exposure under the time-limited tolerances established by this action as well as all existing mandipropamid tolerances in 40 CFR 180.637. EPA assessed dietary exposures from mandipropamid in food as follows:

i. Acute exposure. No such effects were identified in the toxicological studies for mandipropamid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

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 relied upon permanent tolerance level residues established for mandipropamid and 100 percent crop treated (PCT) information for all agricultural commodities. An unrefined chronic exposure assessment that assumes 100 PCT was conducted for the proposed Section 18 uses of mandipropamid. The parent mandipropamid is the residue of concern for tolerance monitoring, and mandipropamid and its major aquatic degradates (SYN 500003 and SYN 5044851) for the risk assessment.

iii. Cancer. EPA has determined that mandipropamid is classified as “not likely to be a human carcinogen” based on the absence of treatment-related increases in tumors in the rat and mouse carcinogenicity studies. Therefore, an exposure assessment to evaluate cancer risk is unnecessary.

iv. Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for mandipropamid. Tolerance level residues and 100 PCT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for mandipropamid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of mandipropamid. 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 First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of mandipropamid for acute exposures are estimated to be 25.2 parts per billion (ppb) for surface water and 0.05 ppb for ground water. The estimated environmental concentrations (EECs) for the aquatic degradates SYN 500003 and SYN 504851 are estimated to be 2.32 and 8.99 ppb for surface water and 0.6 and 1.7 ppb for ground water, respectively. The combined level of mandipropamid and the degradates in surface water is 36.5 ppb.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 36.5 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).

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

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

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to mandipropamid and any other substances, and mandipropamid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that mandipropamid has 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 the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on 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 (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional SF when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is no evidence (quantitative or qualitative) of increased susceptibility and no residual uncertainties with regard to prenatal toxicity following in utero exposure to rats or rabbits (developmental studies) and prenatal and/or postnatal exposures to rats (reproduction study).

3. Conclusion. EPA has determined that reliable data show that 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 mandipropamid is complete except that EPA has determined that an immunotoxicity study is required as per the revised 40 CFR part 158. However, there is no need for an additional uncertainty factor while the immunotoxicity study is completed. The overall weight of evidence in terms of hematology, clinical chemistry, organ weights, and/or histopathology indicates that mandipropamid does not directly target the immune system. Therefore, EPA does not anticipate that conducting a functional immunotoxicity study will result in a lower point of departure than currently selected for the overall risk assessment. The immunotoxicity study should be conducted in conjunction with any future petition for the section 3 registration of mandipropamid.

ii. There is no indication that mandipropamid is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional uncertainty factors (UFs) to account for neurotoxicity.

iii. There is no evidence that mandipropamid 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 dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to mandipropamid 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 mandipropamid.

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. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, mandipropamid is not expected to pose an acute risk.

2. Chronic risk. There are no residential uses for mandipropamid, and therefore aggregate risk is equal to that from consumption of food and water. EPA has concluded that chronic exposure to mandipropamid from food and water will utilize 44% of the cPAD for (children 1 to 2 years of age) the population group receiving the greatest exposure, while the general U.S. population utilizes 26% of the cPAD.

3. Short-term and intermediate 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). Mandipropamid is not registered or proposed for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which was previously addressed.

4. Aggregate cancer risk for U.S. population. As explained in this unit, mandipropamid is not likely to be carcinogenic in 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 mandipropamid residues.

Adequate enforcement methodology (German Multi-residue Method DFG S-19) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 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 no specific Codex, Canadian or Mexican maximum residue limits (MRL) for mandipropamid in or on basil.

Therefore, time-limited tolerances are established for residues of mandipropamid, 4-chloro- N -[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-α-(2-propynyloxy)- benzeneacetamide, in or on basil, fresh at 20 ppm and basil, dried at 240 ppm. These tolerances expire on December 31, 2012.

This final rule establishes tolerances under sections 408(e) and 408(l)(6) of FFDCA. 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 in accordance with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) do not apply.

This 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. To access the harmonized test guidelines referenced in this document electronically, please go 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-2010-0496 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 November 8, 2011. 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-2010-0496, 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 October 22, 2010 (75 FR 65321) (FRL-8851-1), 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 0E7779) by IR-4, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR 180.227 be amended by establishing a tolerance for residues of the herbicide dicamba, 3,6-dichloro-o-anisic acid, and its metabolite 3,6-dichloro-5-hydroxy-o-anisic acid (5-OH dicamba), in or on teff, forage at 90.0 parts per million (ppm); teff, grain at 6.0 ppm; teff, straw at 30.0 ppm; and teff, hay at 40.0 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Helena Chemical Company, 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 tolerance expression for all established commodities to be consistent with current Agency policy. The reason for this change is 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 dicamba including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with dicamba follows.

In the Federal Register of April 2, 2008 (73 FR 17914) (FRL-8356-6), EPA published a final rule establishing tolerances for combined residues of the herbicide dicamba, 3,6-dichloro-o-anisic acid, and its metabolite, 3,6-dichloro-5-hydroxy-o-anisic acid in or on corn, sweet, forage at 0.50 ppm; corn, sweet, kernel plus cob with husks removed 0.04 ppm; and corn, sweet, stover at 0.50 ppm, based on EPA's conclusion that aggregate exposure to dicamba is safe for the general population, including infants and children. Since 2008, there have been no additional tolerance actions for dicamba.

As noted in this unit, the current action concerns a tolerance for dicamba on teff. Teff is an intermediate grass that is morphologically and taxonomically similar to other cereal grains, including wheat. It is used to make flour in a manner similar to wheat and other cereal grains. EPA recently assessed the proposed use of dicamba on teff. In that assessment, EPA determined that aggregate dicamba exposures and risks will not increase as a result of the addition of the proposed teff uses to the uses assessed as part of the 2008 rulemaking. Teff is not included in the Continuing Survey of Food Intakes by Individuals (CSFII). However, because it is used to make flour in a manner similar to wheat and other cereal grains, it will likely substitute in the diet for cereal grain foods which will contain similar residues of dicamba; therefore, a significant increase in dietary exposure to residues of dicamba from consumption of teff-containing foods will not occur. Furthermore, residues of dicamba in teff livestock feeds will be similar to those in other forages, hays, and silages for which tolerances of dicamba are currently established. As such, there would be no increase in the livestock dietary burden should teff be substituted in the livestock diet for other hays and silages; residues in meat, milk, poultry and eggs will remain the same.

Further information about EPA's risk assessment and determination of safety for this action can be found at http://www.regulations.gov in document “2,4-D and Dicamba: Petition for the Establishment of Tolerances on Teff; Request for Registration of Latigo (EPA Reg. No. 5905-564) on Teff.” in docket ID number EPA-HQ-OPP-2010-0496. Except as supplemented by the information described in this unit, EPA is relying on the safety finding in the 2008 rulemaking and the risk assessment underlying that action in establishing the tolerances for dicamba on teff, forage; teff, grain; teff, straw; and teff, hay. Further information regarding the safety finding for the last rulemaking can be found in the Federal Register of April 2, 2008 (73 FR 17917) (FRL-8356-6), at http://www.epa.gov/fedrgstr/EPA-PEST/2008/April/Day-02/p6674.htm.

For the 2008 rulemaking, the toxicity database was considered complete. However, recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing (OPPTS Guideline 870.7800) and acute and subchronic neurotoxicity testing (OPPTS Guideline 870.6200) for pesticide registration. The toxicity database for dicamba includes acceptable acute and subchronic neurotoxicity studies; therefore, the requirements for the neurotoxicity screening battery have been met. Additionally, an immunotoxicity study was recently submitted and is currently under review. A screening level review of this study indicates that no effects, including immunotoxic effects, were observed at the highest dose tested of approximately 307 milligrams/kilograms(mg/kg/day). This value is higher than the doses currently used for risk assessment; therefore, risk assessment endpoints will not change and the toxicity database is considered complete.

Based upon the 2008 rulemaking and the other information discussed in this unit, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children, from aggregate exposure to dicamba residues. Refer to the April 2, 2008 (73 FR 17914) (FRL-8356-6) Federal Register document, available at http://www.regulations.gov, for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register document in support of this action.

Adequate enforcement methodologies, Methods I and II—gas chromatography with electron capture detection (GC/ECD), are available to enforce the tolerance expression. The methods are published in the Pesticide Analytical Manual (PAM) Volume II. 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; e-mail 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 MRLs for dicamba in or on commodities associated with this action.

The EPA has revised the tolerance expression to clarify:

1. That, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of dicamba 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 dicamba, 3,6-dichloro-o-anisic acid, including its metabolites and degradates, in or on teff, forage at 90.0 ppm; teff, grain at 6.0 ppm; teff, straw at 30.0 ppm; and teff, hay at 40.0 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. To access the harmonized test guidelines referenced in this document electronically, please go 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-2010-0466 in the subject line on the first page of your. All requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before November 8, 2011. 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-2010-0466, 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 June 23, 2010 (75 FR 35801) (FRL-8831-3), 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 0F7708) by Makhteshim-Agan of North America, Inc., 4515 Falls of Neuse Road, Raleigh, NC 27609 as well as the filing of a pesticide petition (PP 0E7723) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. The IR-4 petition (PP 0E7723) requested that 40 CFR 180.598 be amended by establishing tolerances for residues of the insecticide novaluron, (N -[[[3-chloro-4-[1,1,2-trifluoro-2- (trifluoromethoxy)ethoxy] phenyl]amino] carbonyl]-2,6-difluorobenzamide), in or on corn, sweet, kernels plus cob with husks removed at 0.05 parts per million (ppm); corn, sweet, forage at 20 ppm; and corn, sweet, stover at 50 ppm and to increase the established livestock tolerances for residues of novaluron in or on milk from 1.0 to 1.5 ppm, and milk fat from 20 to 35 ppm, respectively. The Makhteshim-Agan petition (PP 0F7708) requested novaluron tolerances for all food commodities (other than those already covered by a higher tolerance as a result of use on growing crops) in food handling establishments where food products are held, processed or prepared at 0.01 ppm. That notice referenced a summary of the petitions prepared by Makhteshim-Agan of North America, 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 for PP 0F7708. Comments were received on the notice of filing for PP 0E7723. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the tolerances for sweet corn forage and determined it is not appropriate to raise the existing tolerances for milk and milk fat. The EPA also determined it is appropriate to revise several existing livestock commodities based on the proposed sweet corn use. The reasons for these changes are explained in Unit IV.D.

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

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

Novaluron has low acute toxicity via the oral, dermal, and inhalation routes. No ocular or dermal irritation was noted. Novaluron is not a dermal sensitizer. In subchronic and chronic toxicity studies, novaluron primarily produced hematotoxic effects (toxicity to blood) such as methemoglobinemia, decreased hemoglobin, decreased hematocrit, and decreased red blood corpuscles (RBCs or erythrocytes) that were associated with compensatory erythropoiesis. Increased spleen weights and/or hemosiderosis in the spleen were considered to be due to enhanced removal of damaged erythrocytes and not to an immunotoxic effect.

There was no maternal or developmental toxicity seen in the rat and rabbit developmental toxicity studies up to the limit doses. In the two-generation reproductive toxicity study in rats, both parental and offspring toxicity (increased spleen weights) were observed at the same dose. Reproductive toxicity (decreases in epididymal sperm counts and increase age at preputial separation in the F1 generation) was observed at a higher dose only in males.

Signs of neurotoxicity were seen in the rat acute neurotoxicity study at the limit dose, including clinical signs (piloerection, fast/irregular breathing), functional observation battery (FOB) parameters (head swaying, abnormal gait) and neuropathology (sciatic and tibial nerve degeneration). However, no signs of neurotoxicity or neuropathology were observed in the subchronic neurotoxicity study in rats or in any other subchronic or chronic toxicity study in rats, mice or dogs. Therefore, there is no concern for neurotoxicity resulting from exposure to novaluron.

There was no evidence of carcinogenic potential in either the rat or mouse carcinogenicity studies and no evidence of mutagenic activity in the submitted mutagenicity studies, including a bacterial ( Salmonella, E. coli ) reverse mutation assay, an in vitro mammalian chromosomal aberration assay, an in vivo mouse bone-marrow micronucleus assay and a bacterial DNA damage or repair assay. Based on the results of these studies, EPA has classified novaluron as “not likely to be carcinogenic to humans.”

Specific information on the studies received and the nature of the adverse effects caused by novaluron 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 “Novaluron: Human-Health Risk Assessment for Proposed Section 3 Uses on Sweet Corn and in Food—or Feed-Handling Establishments” at pages 53-56 in docket ID number EPA-HQ-OPP-2010-0466.

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 novaluron 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 novaluron, EPA considered exposure under the petitioned-for tolerances as well as all existing novaluron tolerances in 40 CFR 180.598. EPA assessed dietary exposures from novaluron 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.

No such effects were identified in the toxicological studies for novaluron; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA from 1994-1996 and 1998 Continuing Surveys of Food Intakes by Individuals (CSFII). As to residue levels in food, EPA conducted a partially refined dietary (food and drinking water) exposure and risk assessment for the proposed new uses on sweet corn and in food—and feed—handling establishments, all established uses, and drinking water using the DEEM-FCID (Dietary Exposure Evaluation Model-Food Commodity Ingredient Database), Version 2.03, which uses food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA incorporated average percent crop treated (PCT) data for apples, cabbage, cotton, pears, and potatoes, and utilized percent crop treated for new use PCT estimates for grain sorghum and sweet corn. 100 PCT was assumed for the remaining food commodities. Anticipated residues (ARs) for meat, milk, hog, and poultry commodities were calculated using average field trial residues, PCT estimates for sweet corn and grain sorghum, average PCT for apple and cotton, and assumed 100 PCT for sugarcane and cowpea seed.

The chronic analysis also incorporated average greenhouse trial residues for tomatoes; empirical processing factors for apple juice (translated to pear and stone fruit juice), cottonseed oil, dried plums, and tomato paste and puree; and DEEM default processing factors for the remaining processed commodities; and average field trial residues for all crops unless residues were less than LOQ (If residues were less than LOQ, the chronic analysis assumed 1/2 LOQ values)

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that novaluron 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.

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

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

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

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

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

The Agency estimated the PCT for existing uses as follows:

Apples at 15%; cabbage at 10%; cotton at 2.5%; pears at 10%; and potatoes at 2.5%.

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 estimated the PCT for new uses as follows:

Sweet corn at 59% and sorghum at 5%.

EPA utilized estimated PCT data in the chronic dietary risk assessment for the new use on sweet corn and sorghum, based on the market leader approach. Sorghum, though not new, was only registered 1 year ago. Since sorghum has been registered for such a relatively short period, EPA has sorghum to be a “new use” when estimating the PCT. The market leader approach is the comparison of the PCT with all chemicals of a specific type ( i.e., herbicide, insecticide, etc.) on a specific crop and choosing the highest PCT (market leader) as the PCT for the new use. This method of estimating a PCT for a new use of a registered pesticide or a new pesticide produces a high-end estimate that is unlikely, in most cases, to be exceeded during the initial 5 years of actual use. The predominant factors that bear on whether the estimated PCT could be exceeded are: The extent of the pest pressure on the crops in question; the pest spectrum of the new pesticide in comparison with the market leaders as well as whether the market leaders are well-established for this use; and resistance concerns with the market leaders.

Novaluron has a relatively narrow spectrum of activity compared to the market leaders. Additionally, there are no resistance or pest pressure issues identified for the use of novaluron on sweet corn. All information currently available has been considered for use on sweet corn, and EPA concludes that it is unlikely that the actual sweet corn PCT with novaluron will exceed the estimated PCT for new uses during the next 5 years.

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 novaluron may be applied in a particular area.

2. Dietary exposure from drinking water. The residues of concern in drinking water are novaluron and its chlorophenyl urea and chloroaniline degradates. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for novaluron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of novaluron. 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.

Estimated drinking water concentrations (EDWCs) were not generated for the food-and-feed handling establishment uses because the use pattern is not expected to result in the contamination of drinking water. Based on the Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) for parent novaluron in surface water; and the Screening Concentration in Ground Water (SCI-GROW) models for novaluron, chlorophenyl urea and chloroaniline in ground water, the EDWCs of novaluron, chlorophenyl urea, and chloroaniline for chronic exposures for non-cancer assessments are estimated to be 0.76 parts per billion (ppb), 0.89 ppb and 2.6 ppb, respectively, for surface water and 0.0056 ppb, 0.0045 ppb and 0.0090 ppb, respectively, for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. The highest drinking water concentrations were estimated for surface water. Of the three EDWC values for surface water, the chronic EDWC for the terminal metabolite chloroaniline, is the highest (assuming 100% molar conversion from parent to aniline). This is consistent with the expected degradation pattern for novaluron. Therefore, for chronic dietary risk assessment, the water concentration value for chloroaniline of 2.6 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). Novaluron is not currently registered for any specific use patterns that would result in residential exposure. However, the following uses that could result in residential exposures are pending registration and have been assessed: Indoor and outdoor uses for the control of roaches and crickets (crack and crevice and spot treatments) in residential areas such as homes and apartment buildings, and their immediate surroundings, and on modes of transportation.

There is a potential for exposure in residential settings during the application process for homeowners who use products containing novaluron. There is also a potential for exposure from entering novaluron-treated areas that could lead to exposures to adults and children. Both residential handler and post-application scenarios were assessed for the indoor use since this is believed to cover the outdoor perimeter treatment. Residential handler dermal and inhalation exposures were assessed for application via low-pressure handwands and trigger-pump sprayers.

Additionally exposure routes were assessed for post-application exposures for adults and children via inhalation and dermal routes and post-application incidental oral (hand-to-mouth) exposure for children (3 to < 6 years old). Additionally, a combined residential assessment that consisted of adult dermal and inhalation post-application exposures as well as children (3 to < 6 years old) dermal, inhalation, and oral (hand-to-mouth) post-application exposure was included which details of the residential risk exposure and risk assessment are contained in the EPA public docket EPA-HQ-OPP-2010-0466 at http://www.regulations.gov in document “Novaluron: Human-Health Risk Assessment for Proposed Section 3 Uses on Sweet Corn and in Food- or Feed-Handling Establishments” on pp. 28-37.

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 novaluron to share a common mechanism of toxicity with any other substances, and novaluron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that novaluron 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 prenatal and postnatal toxicology database for novaluron includes rat and rabbit prenatal developmental toxicity studies and a 2-generation reproduction toxicity study in rats. There was no evidence of increased quantitative or qualitative susceptibility following in utero exposure to rats or rabbits in the developmental toxicity studies and no evidence of increased quantitative or qualitative susceptibility of offspring in the reproduction study. Neither maternal nor developmental toxicity was seen in the developmental studies up to the limit doses. In the reproduction study, offspring and parental toxicity (increased absolute and relative spleen weights) were similar and occurred at the same dose; additionally, reproductive effects (decreases in epididymal sperm counts and increased age at preputial separation in the F1 generation) occurred at a higher dose than that which resulted in parental toxicity.

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 novaluron is complete except for immunotoxicity testing and a 90-day inhalation toxicity study. Recent changes to 40 CFR part 158 make immunotoxicity testing (OPPTS Guideline 870.7800) 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 effects were seen in the spleen in two studies, as explained in Unit III.A., EPA has concluded that novaluron does not directly target the immune system and the Agency does not believe that conducting a functional immunotoxicity study will result in a NOAEL lower than the regulatory dose for risk assessment; therefore, an additional database uncertainty factor is not needed to account for potential immunotoxicity. A 90-day inhalation toxicity study is requested for further characterization of inhalation risk. Due to the potential for repeated inhalation exposure anticipated from the proposed residential use pattern, there is concern for toxicity by the inhalation route. An inhalation study would provide a dose and endpoint via the route of exposure of concern ( i.e. route-specific study) and thus would avoid using an oral study and route-to-route extrapolation. Although a point of departure from an oral study was used to assess residential post-application inhalation risks for novaluron, the Agency does not believe this assessment is under-protective. The post-application inhalation MOEs calculated were all greater than 3,000, thus providing an ample margin of safety to account for any uncertainties in route-to-route extrapolation. Further, the MOE was calculated for post-application inhalation exposure and risk using the saturation concentration which is a very conservative approach. The saturation concentration represents what would occur if a large amount of chemical were spilled in a non-ventilated room and allowed to evaporate until equilibrium is reached.

ii. There were signs of neurotoxicity in the acute neurotoxicity study in rats, including clinical signs (piloerection, irregular breathing), functional observation battery (FOB) parameters (increased head swaying, abnormal gait), and neuropathology (sciateic and tibial nerve degeneration). However, the signs observed were not severe, were seen only at the limit dose (2000 mg/kg/day) and were not reproducible. No signs of neurotoxicity or neuropathology were observed in the subchronic neurotoxicity study in rats at similar doses, and no evidence of neuropathology was observed in subchronic and chronic toxicity studies in rats, mice, or dogs. In addition, no clinical signs were observed in the acute oral toxicity study (LD50 > 5,000 mg/kg). Therefore, novaluron does not appear to be a neurotoxicant, and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that novaluron 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 dietary food exposure assessments were performed using anticipated residues derived from reliable residue field trials and PCT assumptions for some commodities. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to novaluron in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers resulting from the proposed residential uses of novaluron. These assessments will not underestimate the exposure and risks posed by novaluron.

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. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, novaluron is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to novaluron from food and water will utilize 72% of the cPAD for children 1 to 2 years old, the population group receiving the greatest exposure. The residential exposure assessment was conducted using high-end estimates of use and potential exposure providing a conservative, health protective estimate of risk.

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).

There are potential short-term exposures from the pending residential uses for novaluron. The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to novaluron.

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 1,600 for the U.S. population and 290 for children 1-2 years old. Because EPA's level of concern for novaluron 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).

There are potential intermediate-term exposures from the pending residential uses for novaluron. The Agency has determined that it is appropriate to aggregate chronic exposure through food and water with intermediate-term residential exposures to novaluron.

Using the exposure assumptions described in this unit for intermediate-term exposures, EPA has concluded that the combined intermediate-term food, water, and residential exposures result in aggregate MOEs of 320 for U.S. population and 140 for children 1-2 years old. Because EPA's level of concern for novaluron 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 two adequate rodent carcinogenicity studies, novaluron 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 novaluron residues.

The following adequate enforcement methodologies (gas chromatography/electron-capture detection (GC/ECD) method and a high-performance liquid chromatography/ultraviolet (HPLC/UV) method) are available to enforce the tolerance expression. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 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 no Codex, Canadian, or Mexican maximum residue limits (MRLs) established for residues of novaluron in or on sweet corn, stover, forage and kernel plus cob with husks removed or for all food commodities based on the use of novaluron in food and feed handling establishments. Canada is currently in the process of reviewing the use of novaluron on sweet corn. The EPA and the Pest Management Regulatory Agency (PMRA) reviewed the sweet corn petition as a Joint Review Project and tolerance recommendations are in agreement at 0.05 ppm for sweet corn and kernel plus cob with husks removed. Additionally, PMRA proposed to increase its MRL for milk to 1.0 ppm from 0.5 ppm, and as a result the EPA and PMRA milk tolerances/MRLs will be in agreement. The PMRA does not recommend MRLs for livestock feed commodities and therefore will not establish MRLs for sweet corn stover and sweet corn forage.

EPA received one comment to the Notice of Filing that made a general objection to the presence of any novaluron residues on vegetable crops. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned on agricultural crops. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This citizen's comment appears to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework. The commenter also expressed concern that EPA's risk assessment for novaluron did no “combined testing” with other chemicals. EPA, however, does not require “combined testing” of a pesticide with other pesticides or other chemicals due to impracticality. With regard to the potential for cumulative effects from exposure to the pesticide and other substances with a common mechanism of toxicity, see the discussion of this issue in Unit III.C.4., Cumulative effects from substances with a common mechanism of toxicity.

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, EPA revised the proposed tolerance on corn, sweet, forage from 20 ppm to 16 ppm and determined no change to the existing milk and milk fat tolerances is needed.

Based on the proposed use on sweet corn, the revised reasonably balanced dietary burdens (RBDBs) for novaluron are 9.6 ppm for beef cattle, 18.3 ppm for dairy cattle, 2.4 ppm for poultry, and 2.5 ppm for swine. Accordingly, the Agency has determined it is appropriate to raise the existing tolerances for meat byproducts. However, no changes are necessary for the tolerances for secondary residues in/on cattle, goat, horse, sheep, poultry, and swine commodities. Additionally, commodity terms for hog, meat byproducts and poultry, meat byproducts are being revised.

Therefore, the tolerances for meat byproducts are being revised as follows: Cattle, meat byproducts, except kidney and liver from 0.60 ppm to 11 ppm; goat, meat byproducts, except kidney and liver from 0.60 ppm to 11 ppm; horse, meat byproducts, except kidney and liver from 0.60 ppm to 11 ppm; sheep, meat byproducts, except kidney and liver from 0.60 ppm to 11 ppm; hog, meat byproducts from 0.10 ppm to hog, meat byproducts, except kidney and liver to 1.5 ppm; and poultry, meat byproducts from 0.80 ppm to poultry, meat byproducts, except kidney and liver to 7.0 ppm.

Therefore, tolerances are established for residues of novaluron, (N-[[[3-chloro-4-[1,1,2-trifluoro-2- (trifluoromethoxy)ethoxy] phenyl]amino]carbonyl]-2,6-difluorobenzamide), in or on corn, sweet, kernels plus cob with husks removed at 0.05 ppm; corn, sweet, forage at 16 ppm; corn, sweet, stover at 50 ppm; cattle, meat byproducts, except kidney and liver at 11 ppm; goat, meat byproducts, except kidney and liver at 11 ppm; horse, meat byproducts, except kidney and liver at 11 ppm; sheep, meat byproducts, except kidney and liver at 11 ppm; hog, meat byproducts, except kidney and liver at 1.5 ppm; poultry, meat byproducts, except kidney and liver at 7.0 ppm; and Food/feed commodities (other than those covered by a higher tolerance as a result of use on growing crops) in food/feed handling establishments 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. To access the harmonized test guidelines referenced in this document electronically, please go 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-2010-0905 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 November 8, 2011. 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-2010-0905, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 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 February 4, 2011 (76 FR 6465) (FRL-8858-7), 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 0F7796) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 08540. PP 0F7796 was incorrectly reported and should have read PP 0E7796, the correct petition number. The petition requested that 40 CFR 180.142 be amended by establishing a tolerance for residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid), both free and conjugated, determined as the acid, in or on teff, bran at 4.0 parts per million (ppm); teff, forage at 25.0 ppm; teff, grain at 2.0 ppm; and teff, straw at 50.0 ppm. That notice referenced a summary of the petition prepared on behalf of IR-4 by Helena Chemical Company, the registrant, which is available in the docket, http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the tolerance expression for all established commodities to be consistent with current Agency policy. The reason for these changes is explained in Unit IV.D.

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

Consistent with 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 2,4-D including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with 2,4-D follows.

In the Federal Register of July 27, 2005 (70 FR 43298) (FRL-7726-8), EPA published a final reestablishing tolerances for combined residues of the herbicide 2,4-D (2,4-dichlorophenoxyacetic acid), in or on hops, wild rice, and soybeans, based on upon EPA's conclusion that aggregate exposure to 2,4-D is safe for the general population, including infants and children. Since 2005, there have been no additional tolerance actions for 2,4-D.

As noted in this unit, the current action concerns a tolerance for 2,4-D on teff. Teff is an intermediate grass that is morphologically and taxonomically similar to other cereal grains, including wheat. It is used to make flour in a manner similar to wheat and other cereal grains. EPA recently assessed the proposed use of 2,4-D on teff. In that assessment, EPA determined that aggregate 2,4-D exposures and risks will not increase as a result of the addition of the proposed teff uses to the uses assessed as part of the 2005 rulemaking. Teff is not included in the Continuing Survey of Food Intakes by Individuals (CSFII). However, because it is used to make flour in a manner similar to wheat and other cereal grains, it will likely substitute in the diet for cereal grain foods which will contain similar residues of 2,4-D; therefore, a significant increase in dietary exposure to residues of 2,4-D from consumption of teff-containing foods will not occur. Furthermore, residues of 2,4-D in teff livestock feeds will be similar to those in other forages, hays, and silages for which tolerances of 2,4-D are currently established. As such, there would be no increase in the livestock dietary burden should teff be substituted in the livestock diet for other hays and silages; residues in meat, milk, poultry and eggs will remain the same.

Further information about EPA's risk assessment and determination of safety for this action can be found at http://www.regulations.gov in document “2,4-D and Dicamba: Petition for the Establishment of Tolerances on Teff; Request for Registration of Latigo (EPA Reg. No. 5905-564) on Teff.” in docket ID number EPA-HQ-OPP-2010-0905. Except as supplemented by the information described in this unit, EPA is relying on the safety finding in the 2005 rulemaking and the risk assessment underlying that action in establishing tolerances for 2,4-D on teff, bran; teff, forage; teff, grain; and teff, straw. Further information regarding the safety finding for the last rulemaking can be found in the Federal Register of July 27, 2005 (70 FR 43307) (FRL-7726-8), at http://www.epa.gov/fedrgstr/EPA-PEST/2005/July/Day-27/p14886.htm.

For the 2005 rulemaking, the 2,4-D toxicity database was considered complete except for the submission of a developmental neurotoxicity study (DNT) and a repeat 2-generation reproduction study. The absence of these studies led EPA to retain an additional safety factor for the protection of infants and children as provided by FFDCA section 408(b)(2)(C). Additionally, recent changes to 40 CFR part 158 imposed new data requirements for immunotoxicity testing (OPPTS Guideline 870.7800) and acute and subchronic neurotoxicity testing (OPPTS Guideline 870.6200) for pesticide registration. All of these data requirements have now been met. The toxicity database for 2,4-D includes acceptable acute and subchronic neurotoxicity studies; therefore, the requirements for the neurotoxicity screening battery have been met. To address the other deficiencies, the registrant submitted an F1-extended 1-generation toxicity study in rats. This study has been reviewed and found acceptable, and fulfills the outstanding requirements for a DNT study, a repeat 2-generation reproduction study, and immunotoxicity testing. After review of these studies, EPA has concluded that they do not affect EPA's derivation of 2,4-D's acute reference dose (aRfD) or chronic reference dose (cRfD). It is likely, however, that in the future EPA will remove the additional safety factor for the protection of infants and children now that the 2,4-D database is complete. Thus, once a full reassessment of 2,4-D is completed, estimated risks are likely to decline substantially. However, because a full reassessment of 2,4-D risk taking into account the new studies has not been formally conducted, EPA is relying primarily on the 2005 rulemaking to support this action. Therefore, the safety finding for this action relies on the additional margin of safety provided by retaining the additional safety factor for protection of infants and children. For further information on EPA's review of these studies, information is available at http:// www.regulations.gov, in docket ID number EPA-HQ-OPP-2010-0905.

In the 2005 rulemaking, EPA relied upon data showing the percent of crops treated with 2,4-D in assessing chronic risk. In evaluating the proposed teff tolerances, EPA considered updated data on percent crop treated and has concluded that the updated data would increase the chronic risk estimates from the 2005 assessment for the general population and children 1-6 years old (the most sensitive subpopulation) by 2.2% and 3.1% of the cPAD, respectively. Because the chronic risk estimates for the 2005 assessment were well below the level of concern, these differences are considered insignificant.

Therefore, based upon the 2005 rulemaking and the other information discussed in this unit, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to 2,4-D residues. Refer to the July 27, 2005 (70 FR 43298) (FRL-7726-8) Federal Register document, available at http://www.regulations.gov, for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in the Federal Register document in support of this action.

Adequate enforcement methodology, a gas chromatography with electron capture detection (GC/ECD) method, designated as EN-CAS Method No. ENC-2/93, is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 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 MRLs for 2,4-D in or on any commodities associated with this action.

EPA received one comment to the Notice of Filing that made a general objection to proposed new tolerances and new tolerance exemptions for several chemicals, including 2,4-D. The commenter additionally noted that, “prior to approval of these or other chemicals in the food system the EPA must be confident that these will not cause harm” and “only long term studies can provide data on the health impact of exposure to these chemicals.” The commenter stated that none of the mentioned chemicals, including 2,4-D, should be permitted in food.

The Agency understands the commenter's concerns and recognizes that some individuals believe that certain pesticide chemicals should not be permitted in our food. However, the existing legal framework provided by section 408 of the FFDCA states that tolerances may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. When new or amended tolerances are requested for residues of a pesticide in food or feed, the Agency, as is required by section 408 of the FFDCA, estimates the risk of the potential exposure to these residues. The Agency has concluded after this assessment, which includes the consideration of long-term animal studies with 2,4-D, that there is a reasonable certainty that no harm will result from aggregate human exposure to 2,4-D and that, accordingly, the 2,4-D tolerances on teff are “safe.”

The EPA has revised the tolerance expression to clarify:

1. Tvided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of 2,4-D not specifically mentioned; and 2. Tcompliance 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 2,4-D (2,4-dichlorophenoxyacetic acid), including its metabolites and degradates, in or on teff, bran at 4.0 ppm; teff, forage at 25.0 ppm; teff, grain at 2.0 ppm; and teff, straw at 50.0 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:

This is a summary of the Order , DA 11-1432, adopted on August 24, 2011, and released on August 24, 2011 under delegated authority, with erratum released August 25, 2011. The full text of this document is available for public inspection and copying during regular business hours in the FCC Reference Center, Federal Communications Commission, 445 12th Street, SW., CY-A257, Washington, DC 20554. This document will also be available via ECFS ( http://www.fcc.gov/cgb/ecfs/ ). (Documents will be available electronically in ASCII, Word 97, and/or Adobe Acrobat.) The complete text may be purchased from the Commission's copy contractor, 445 12th Street, SW., Room CY-B402, Washington, DC 20554. To request this document in accessible formats (computer diskettes, large print, audio recording, and Braille), send an e-mail to fcc504@fcc.gov or call the Commission's Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

This final rule is being issued without prior notice and opportunity to comment pursuant to authority under the Administrative Procedures Act, 5 U.S.C. 553(b)(3)(B). The rule amendments adopted in this Order are nonsubstantive, editorial revisions of the Commission's rules pursuant to § 0.231 (b) of the Commission's rules, and merely delete obsolete rule provisions. The Commission finds good cause to conclude that notice and comment procedures are unnecessary and would not serve any useful purpose.

This document contains no new or modified information collection requirements. The rules contained herein have been analyzed with respect to the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. 3501, et seq. , and found to contain no new or modified form, information collection, and/or recordkeeping, labeling, disclosure, or record retention requirements, and will not increase or decrease burden hours imposed on the public. In addition, therefore, this Order does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, 44 U.S.C. 3506(c)(4). The Commission will send a copy of the Order in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act.

Because this Order is being adopted without notice and comment, the Regulatory Flexibility Act, 5 U.S.C. 601, et seq. , does not apply.

1. In this Order, we make several nonsubstantive, editorial revisions to parts 1, 73 and 76 of the Commission's rules. We make these revisions to delete certain rule provisions that are without current legal effect and obsolete.

2. Specifically, this Order removes Broadcast Applications and Proceedings rules part 1, subpart D of the Commission's rules, §§ 1.502 through 1.615 of the Commission's rules. This Order removes broadcast and cable rules, §§ 73.1910 and 76.209 of the Commission's rules, which reference the Commission's so-called “Fairness Doctrine.” This Order removes cable personal attack and political editorial rules, §§ 76.1612 and 76.1613 of the Commission's rules.

3. This Order removes the Commission's “Broadcast Flag” rules, part 73, subparts L and M, of the Commission's rules, §§ 73.8000 and 73.9000 through 73.9009 of the Commission's rules. This Order deletes the Commission's cable programming services (CPST) complaint process rules, §§ 76.950, 76.951, 76.953, 76.954, 76.955, 76.956, 76.957, 76.960, 76.961, 76.1402, 76.1605 and 76.1606 of the Commission's rules.

For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR parts 1, 73 and 76 as follows:

Background

On August 26, 2010, FRA issued a Notice of Proposed Rulemaking (NPRM) as a first step to the agency's promulgation of concrete crosstie regulations per the Congressional mandate contained in Section 403(d), of the Rail Safety Improvement Act of 2008 (Pub. L. 110-432, Division A) (RSIA). See 75 FR 52,490. On April 1, 2011, following consideration of written comments received in response to the NPRM, FRA published a final rule mandating specific requirements for effective concrete crossties, for rail fastening systems connected to concrete crossties, and for automated inspections of track constructed with concrete crossties. See 76 FR 18,073. FRA received two petitions for reconsideration in response to the final rule.

On May 5, 2011, the International Brotherhood of Teamsters, Brotherhood of Maintenance of Way Employes Division (BMWED) filed a petition for reconsideration (BMWED Petition) of the final rule and on May 27, 2011, the Association of American Railroads (AAR) filed a petition for reconsideration (AAR Petition) of the final rule. In order to provide sufficient time to fully consider both Petitions, FRA delayed the effective date of the final rule until October 1, 2011. See 76 FR 34,890 (June 15, 2011).

The specific issues raised by these petitioners and FRA's responses to their petitions, are discussed in detail below in the “Section-by-Section Analysis” portion of the preamble. The Section-by-Section analysis also contains a detailed discussion of each provision of the final rule which FRA has amended or clarified. The amendments contained in this document generally clarify requirements currently contained in the final rule or allow for greater flexibility in complying with the rule, and are within the scope of the issues and options discussed, considered, or raised in the NPRM.

The final rule provides that concrete crossties shall not be “broken through or deteriorated to the extent that prestressing material is visible.” 49 CFR 213.109(d)(1). AAR requests that FRA amend 49 CFR 213.109(d)(1) to state, “broken through or deteriorated to the extent outer prestressing strands are no longer in tension.” AAR Petition at 3-4. In proposing such language, AAR asserts that FRA is inconsistent with the specifications in 49 CFR 213.335(d)(1) for Class 6 track. See AAR Petition at 3. AAR argues that “FRA's concern is whether the prestressing material is in tension,” as demonstrated by the discussion in the final rule. AAR Petition at 3.

FRA declines to adopt AAR's recommendation to modify the language of 49 CFR 213.109(d)(1). The intent of 49 CFR 213.109(d)(1) is to ensure that concrete crossties with reinforcing strands that have lost their bond to the concrete are considered defective. This intent is clearly described in the preamble to the final rule. See 76 FR 18,077-18,079 (Apr. 1, 2011). While a concrete crosstie that is “broken through or deteriorated to the extent outer prestressing strands are no longer in tension” would be defective, the standard that AAR proposes is difficult to quantify in the field, as an inspector would have difficulty knowing if the prestressing strands are no longer in tension. AAR's proposal would add a qualifier to the standard, making the regulation more subjective and more difficult to enforce.

AAR suggests using the same standard for § 213.109(d)(1) as specified in § 213.335(d), for Class 6 track. Section 213.335(d) provides that the crosstie cannot be “so deteriorated that the prestress strands are ineffective or withdrawn into the tie at one end and the tie exhibits structural cracks in the rail seat or in the gage of track.” FRA believes that the standard adopted for lower speeds of track in § 213.109(d)(1) improves upon § 213.335(d) for lower classes of track by more clearly defining what it means to be “ineffective” and explaining how to find “structural cracks.” FRA notes that while further study would be needed to determine whether this clarifying language would also be appropriate in higher classes of track, any potential amendment to § 213.335(d) would be outside the scope of this proceeding, as modifications to the language in § 213.335(d) was neither raised in the NPRM, nor discussed in the final rule. However, FRA would be willing to address the language in § 213.335(d) in future updates to part 213.

AAR further states that FRA's position to reject the proposed phrase “completely broken through” for § 213.109 is unconvincing. See AAR Petition at 3. Contrary to this concern, FRA's intent was to simply provide consistency in the language used for wooden crossties and does not find it necessary to introduce ambiguity by adopting differing language without sufficient justification.

Although AAR is concerned with the situations where prestressing material is visible and yet not defective, FRA clearly explained in the preamble to the final rule in response to AAR's comment that FRA is not concerned with prestressing material being visible due to a wheel impact or due to the manufacturing process. See 76 FR 18,077-18,079 (Apr. 1, 2011). FRA thoroughly explained its intent in the preamble that by saying the material is “visible” it does not mean “a concrete tie being simply chipped due to wheel impact as opposed to actual deterioration.” 76 FR 18,077 (Apr. 1, 2011). FRA also clarified that it is “not concerned with reinforcing material that may be left visible on the end of a tie during the manufacturing process.” 76 FR 18,077 (Apr. 1, 2011). While this explanatory language is not in the rule text itself, it is clear that FRA intended to clarify in the preamble those prestress concrete crosstie conditions that are of concern to the agency. See Nov. 18, 2008, Concrete Crossties Task Force (CCTF) meeting document (TSCCTF08-1118-06 CONSENSUS WG & TF CLEAN Document For Concrete Crossties, “NOTE: FRA wants to describe pre-stress tie conditions, to be covered in the compliance manual or preamble”). As FRA adequately addressed AAR's comment to the NPRM in the preamble to the final rule, FRA declines to adopt AAR's proposed change to § 213.109(d)(1).

AAR argues that § 213.109(d)(6) should be amended to state: “[c]onfigured with less than two fasteners on the same rail except (i) as provided in § 213.127(c) and (ii) where the fastenings on two adjacent ties on class 1 and class 2 track provide the equivalent of the fastenings on one tie, in which case the two adjacent ties shall be counted as one tie.” AAR Petition at 5.

This issue was raised by AAR in previous comments and addressed by FRA in the final rule. AAR has provided nothing new to sway the agency's views on the issue. Thus, FRA is again declining to adopt the proposal. See 76 FR 18,077 (Apr. 1, 2011). In response to the issue, FRA has already stated the following:

As noted above, FRA believes that it responded to this issue adequately in the preamble to the final rule and that this issue is duplicative and need not be addressed. See 49 CFR 211.29(c). However, FRA would like to take this opportunity to further explain its reasoning. Although AAR argues that the rule text that disqualifies concrete crossties under the conditions described will impose a significant cost on the industry, FRA notes that it has not changed its enforcement policy in the final rule and those concrete crossties that are unable to hold fasteners would have been defective even prior to the issuance of the final rule. The final rule did not modify the existing requirement that any type of crosstie with a missing fastener is considered defective in part 213. The Track Safety Standards require that to be an effective crosstie, it must be able to hold fasteners that can restrain the rail. The crosstie, rail, and fasteners work together as a system to provide effective restraint. 1 FRA concedes that the BNSF Railway (BNSF), the only railroad known to FRA that utilizes defective crossties in this manner, will need to spend substantial funds to remediate any trackage that consists of these defective crossties. However, this cost is not a new cost as a result of the final rule, but merely the cost of compliance with part 213 as it existed prior to the final rule. Finally, amending the rule text is not an appropriate avenue to address one railroad's isolated and limited practice on approximately fifty miles of non-mainline track. 2 A more appropriate avenue would be for BNSF to seek a waiver from the FRA Railroad Safety Board, pursuant to the procedures contained in 49 CFR part 211. 3

AAR requests amending § 213.109(e)(1) to add “(50 inches in the case of concrete ties)” after “48 inches” and § 213.109(e)(3) to add “(25 inches in the case of concrete ties)” after “24 inches.” AAR Petition at 6.

The spacing requirements for crossties at rail joints contained at § 213.109(e), were not modified by the final rule. The specifications for crossties' spacing are based on providing sufficient support to a rail joint and are not dependent on the type of crosstie material used, whether the crossties are made of wood or concrete. For Class 1 and Class 2 track, the regulation provides that each rail joint shall be supported by at least one crosstie whose centerline is within 24 inches of each rail joint location. 49 CFR 213.109(e)(1). For Classes 3, 4, and 5, each rail joint shall by supported by either at least one non-defective crosstie within 18 inches of the joint, or have two crossties, one on each side of the rail joint, whose centerlines are within 24 inches of the rail joint. 49 CFR 213.109(e)(2), (3). The Track Safety Standards already allow for flexibility in the spacing of crossties. 4 Although it may be true that the industry spaces concrete crossties further apart than wooden crossties, all crossties, wood or concrete, must provide effective support for the rail joint.

AAR's suggestion does not appear to have been previously raised in the RSAC process or in any of the comments to the NPRM. Nor has AAR provided FRA with any data to support its contention that concrete crossties should be treated differently from wood crossties in this manner. Moreover, AAR has not provided any basis for why FRA must consider these additional facts, or explained why these facts were not presented to the Administrator within the allotted time. See 49 CFR 211.29(b). Thus, FRA is denying AAR's request. Furthermore, for the reasons noted above, FRA believes that the issue being raised by AAR is outside the scope of this proceeding and that it is inappropriate for FRA to address the issue at this late stage of the rulemaking proceeding.

AAR argues that “today's automated inspection equipment cannot measure rail seat deterioration at all, let alone within 1/8 of an inch.” AAR Petition at 5. Further, AAR states that “automated equipment is not capable of meeting the standard set forth in subsection 213.234(d).” AAR suggests deleting § 213.234(d), (e), and (h). See AAR Petition at 5.

Throughout the RSAC process, the parties agreed that automated inspections were a good approach to locating areas of rail seat deterioration. Indeed, the NPRM states that “[o]ther than automated inspection, there are currently no other tools capable of aiding in the detection of rail seat deterioration.” 75 FR 52,497 (Aug. 26, 2010). FRA is surprised that AAR asserts at this stage in the rulemaking process that the technology to perform these types of automated inspections does not exist.

Although AAR is technically correct that automated equipment cannot currently measure rail seat deterioration directly, today's automated equipment can indicate locations of rail seat deterioration. Rail seat deterioration is indicated as a result of interpolations and calculations from rail cant measurements. The rail cant measurements provide an indication to the designated § 213.7 person that the location should be field-verified. The railroad industry did not want to be limited to a requirement to locate rail seat deterioration through automated inspection using the rail cant method alone. In response to this concern, FRA removed the provision initially proposed in the NPRM requiring automated inspections of rail cant. Instead, FRA chose to use “a performance-based standard” for automated inspections that would indicate rail seat deterioration to the accuracy specified by § 213.234, or 1/8 of an inch, without mandating which technology should be used. See 76 FR 18,076-18,077, 18,080-18,081 (Apr. 1, 2011).

The design and practicality of all automated and autonomous geometry measurement systems is a supplement to visual inspection efforts toward identifying locations of greatest derailment risk. It has been FRA's objective and policy that on-the-ground visual verification must be done by inspectors to validate not only rail seat deterioration, but all track structure and geometry conditions discovered by automated means. A credible gage measurement restraint system (GRMS) is the preferred choice, however, only FRA's DOTX 218 is properly equipped to vertically and laterally load the rails into the crosstie seat area. FRA's other cars load vertically, but not necessarily completely load the rails laterally to “seat” the rail on the crosstie pad in all instances. FRA's rail profiling system (rail cant method) provides a highly accurate indication (advisory) of possible rail seat deterioration. FRA's safety strategy is to promptly identify rail seat deterioration locations with DOTX 217, 219, and 220 cars' onboard rail profiling systems, then re-inspect those areas indicating rail seat deterioration conditions. FRA's automated inspection vehicle uses rail cant to indicate areas of rail seat deterioration, to an accuracy level of within at least one degree of rail cant, which is equivalent to 1/8 of an inch of rail seat deterioration.

Additionally, there were presentations made at the CCTF meetings as part of the RSAC process, describing technologies that can detect or indicate rail seat abrasion. These included systems used by Georgetown Rail Equipment Company, Holland Company LP, and ENSCO, Inc. 5 Georgetown Rail Equipment Company represents that their “scanning” system utilizes laser imagery to “see” height differences of ties, scanning both the inside and outside of the crosstie. 6 FRA believes that BNSF may use this “scanning” system currently on parts of its concrete crossties trackage. AAR's Petition included geometry car reports for a track geometry car that operated over BNSF's Seadrift subdivision on December 14, 2010, measuring rail cant. See AAR Petition at 5, 25, 32. While FRA's system of calculating rail cant cannot technically “measure” rail seat deterioration, it does provide indications of rail seat deterioration. FRA realizes that the rule text is technically incorrect to require that an automated inspection measurement system “measure” rail seat deterioration to within 1/8 of an inch. FRA wishes to clarify that it is requiring the automated measurement system to “locate” rail seat deterioration. It is up to the railroad whether it will use rail cant to indicate locations of rail seat deterioration, to utilize the scanning capability that has been proven effective at detecting dangerous areas of rail seat deterioration, or to use any other demonstrated effective and accurate technology.

FRA also recognizes that detecting rail cant alone will not necessarily demonstrate all possible locations of rail seat deterioration. For example, FRA's geometry car will not find areas of rail seat deterioration that are due to compression forces from loads onto the crosstie. However, FRA's geometry car will locate rail seat deterioration due to rail cant in curved track, which are the hardest areas to detect manually. The automated inspection provision contained in § 213.234 was never intended to require railroads to detect all areas of rail seat deterioration, but rather to supplement manual visual inspections.

Automated inspection technology is able to detect rail seat deterioration to an accuracy of 1/8 of an inch, as demonstrated above. Furthermore, the Final Regulatory Impact Analysis explained in detail how FRA estimated the costs of possible upgrades to railroads' existing technology or equipment to detect rail seat deterioration. See document number 6 in the public docket of this proceeding, at 38. FRA believes that all Class 1 railroads, Class 2 railroads, intercity passenger railroads, and commuter railroads servicing a community greater than 50,000 people currently conduct automated geometry inspections of their track at frequencies roughly twice as great as those required in the final rule. Moreover, most major railroads with concrete crossties already perform automatic inspections to detect rail seat deterioration (either through the rail cant method or through the “scanning” method), and most of these railroads already have equipment that can measure within 1/8 of an inch of accuracy. 7 Thus, FRA denies AAR's request to delete the automated inspection requirements contained in § 213.234, but FRA clarifies that by requiring measurement of rail seat deterioration, FRA actually meant that the technology had to “indicate” rail seat deterioration. Consequently, FRA amends § 213.234(d) and (g) accordingly.

BMWED urges that FRA amend the final rule to require “exception report data to be provided to, or made readily available to, persons fully qualified under § 213.7, including track inspectors responsible for performing § 213.233 visual track inspection in between automated inspection cycles.” BMWED Petition at 5. To support its argument, BMWED cites to other provisions in the CFR that mandate focused dissemination and availability of reports. See BWMED Petition at 5-6.

FRA accepts BMWED's proposed amendment to the final rule. The final rule states that “[t]he automated inspection measurement system shall produce an exception report containing a systematic listing of all exceptions to § 213.109(d)(4), identified so that an appropriate person(s) designated as fully qualified under § 213.7 can field-verify each exception.” 49 CFR 213.234(e). The final rule requires that “[e]ach exception must be located and field-verified no later than 48 hours after the automated inspection” and “[a]ll field-verified exceptions are subject to all the requirements [of part 213].” 49 CFR 213.234(e). FRA notes that § 213.234(e) implicitly requires that persons fully qualified under § 213.7 and whose territories are subject to automated inspection under § 213.234 be provided with, or have ready access to a copy of the exception report, because without such information being disseminated, § 213.234(e) cannot be satisfied. In short, qualified persons under § 213.7 cannot logically field-verify exceptions found in the exception report without access to the exception report. Furthermore, it is in the best interest of the railroad to provide all track inspectors in the relevant territory with access to the exception report so that problem areas can be monitored and corrected. 8

It was FRA's intent in the final rule that the railroad would voluntarily provide all persons fully qualified under § 213.7 with a copy of the exception report, so that both a supervisor under § 213.7(a) and a track inspector under § 213.7(b) would have access to the report. It is expected that the designated § 213.7 person(s) would then act responsibly upon the information subject to the requirements in part 213, once verified, so that appropriate remedial action would be taken in a timely manner.

This issue was raised in the joint comments to the NPRM of the American Train Dispatchers Association (ATDA), Brotherhood of Locomotive Engineers and Trainmen (BLET), Brotherhood of Maintenance of Way Employees Division (BMWED), Brotherhood of Railroad Signalmen (BRS), and the United Transportation Union (UTU) (Labor) and addressed by FRA in the final rule. Labor representatives recommended that FRA mandate that a physical copy of the exception report be given to the person that the track owner has designated as being responsible for frequency inspections pursuant to § 213.233. In response, FRA declined to adopt Labor's recommendation, stating that it “refuses to interfere with a track owner's assignment process.” 76 FR 18,081 (Apr. 1, 2011). FRA clarified that it “agrees that it would be a best practice for the track owner to ensure that the person responsible for performing the frequency inspections required by § 213.233 be provided a copy of the exception report, as all field-verified exceptions are subject to all of FRA's Track Safety Standards.” 76 FR 18,081 (Apr. 1, 2011).

FRA intended to convey with its response to Labor's comment that it would not direct the manner in which a track owner communicates and assigns corrective action to a noncompliant condition among their personnel. The final rule requires that an exception report be created, but does not explicitly require that the report be given to a particular person, as long as a fully-qualified person under § 213.7 properly field-verifies any exceptions pursuant to the rule. Persons designated under § 213.7 must receive or have access to the exception report in order to comply with the provisions of the final rule. In other words, a designated qualified inspector is required by the final rule to receive any noncompliant rail seat deterioration reports, whether the reports are made accessible to or are physically handed to the person designated under § 213.7, for field-verification and repairs purposes.

While FRA addressed Labor's comments in the preamble to the final rule, BWMED's Petition modified Labor's recommendation by asking that FRA require that individuals performing frequency inspections be provided with a copy of the automated inspection report or that a copy of the automated inspection report be made readily available. With this alteration, FRA believes that BWMED's request becomes less burdensome on the railroads. Railroads have an incentive to make such automated inspection reports available to track inspectors performing frequency-based inspections because this practice could ensure compliance with the regulations and could prevent worsening track conditions with costlier repairs or potential accidents. If inspectors have been provided with all of the relevant information, inspectors can better monitor problematic areas. Further, as this is a good business practice, most Class 1 railroads already make these reports available to the relevant inspectors. Given that the benefits of making reports available to all inspectors in the territory outweigh the slight cost of requiring a railroad to make the report available, which many do already, FRA is amending the final rule to explicitly require that railroads make such reports available to all relevant § 213.7 persons. The marginal increase in cost of making the report available compared with the added benefit of allowing inspectors to note defects earlier justify adding this requirement.

To clarify FRA's original intent and to promote good industry practice, FRA amends § 213.234(e) to require that exception reports be provided to or are made available to all persons qualified under § 213.7 and whose territories are subject to the requirements of § 213.234.

BMWED asserts that “§ 213.234(d)(1) has the affect [sic] of adding up to an additional 1/8 of an inch to the proposed maximum depth of 1/2 inch rail seat deterioration prescribed under § 213.109(d)(4).” BMWED Petition at 2. Thus, BMWED requests that FRA “compensate for the 1/8 inch calibration variance” by requiring “the automated exception report [to] record all `exceptions' of 3/8 of an inch or greater, and that all such exceptions be subject to field verification under the provisions of § 213.234(e).” BMWED Petition at 2-3. BMWED contends that because of the 1/8 of an inch variance allowed by § 213.234(d)(1), exceptions may reach up to 5/8 of an inch before automated means would detect them. See BMWED Petition at 5.

FRA accepts BMWED's recommendation that railroads must flag locations identified as 3/8 of an inch or greater on the automated exception report, but FRA declines to require field-verification of those areas noted on the report that are less than 1/2 of an inch. This additional notation will serve as an alert to the inspectors of potential problem areas to observe. Generally, railroads already note locations on automated reports in advance of the 1/2 of an inch violation level. For example, BNSF already flags locations at 3/8 of an inch with an alert. Adding an “alert” to an automated exception report would be a simple and low-cost modification. For example, Rail Profile Measurement System (RPMS) instrumentation on FRA geometry cars are set to flag an advisory exception when the angle exceeds four degrees of negative or outward rail cant. See 76 FR 18,081 (Apr. 1, 2011). However, requiring field-verification of locations flagged below 1/2 of an inch would be inappropriate, as it would impose too high of a cost without a corresponding benefit to safety.

FRA estimates that there would be approximately eight times as many locations found at 3/8 of an inch than those found at 1/2 of an inch. This increase would result in eight times as many field-verifications, and would consequently represent a significant increase in the economic burden. Measurement errors are usually equally distributed as positive and negative, meaning that having a target of 3/8 of an inch would trigger exceptions that actually measure 1/4 of an inch as often as 1/2 of an inch. FRA notes that this would cause unneeded inspections for such false-positives at a high cost. However, there are potential cost savings, as the additional field-verification may result in the repair of an issue that would have been more costly to repair later or could have contributed to an accident. BMWED's Petition recommends that FRA adopt something higher than a minimum safety standard. If FRA takes violations before the railroad is noncompliant, it would be contrary to FRA's enforcement policy and would be interfering with the railroad's managerial discretion.

While railroads astutely demand higher than minimum standards, FRA only requires the minimum for safety purposes. A location indicating rail seat deterioration of 3/8 of an inch would likely fall within a railroad's maintenance standard to watch or to field-verify, but such field-verification will not be mandated by FRA. FRA agrees with BMWED that it would be a good practice and thus mandates that automated inspection equipment must note all locations indicating rail seat deterioration of 3/8 of an inch and greater on the report, yellow-flagging, or identifying “alerts” for, those areas identified between 3/8 and 1/2 of an inch, and red-flagging, or identifying “alarms” for, those areas identified at 1/2 of an inch and above. However, subjecting all areas 3/8 of an inch and above to field-verification would add significant cost burdens without a demonstrated safety benefit.

In light of the preceding discussion, a new paragraph is added to § 213.234(e) to require exception reports to note an “alert” for locations identified between 3/8 of an inch and 1/2 of an inch.

AAR asserts that “[r]ailroads traditionally concentrate training classes for their existing employees in the first half of the year, with training materials prepared during the second half of the previous year.” AAR Petition at 7. By postponing the applicability date of the formal training provision in § 213.234(h) to July 1, 2012, these requirements would comport with the railroads' standard training schedule.

In consideration of these typical railroad training cycles, FRA will extend the applicability date of § 213.234 to July 1, 2012. Accordingly, FRA amends 49 CFR 213.234(a).

Prior to issuing the April 1, 2011 final rule, FRA prepared and placed in the docket a regulatory analysis addressing the economic impact of the final rule. The rule was evaluated in accordance with existing policies and procedures and determined to be non-significant under both Executive Orders 12866 and 13563 and DOT policies and procedures. See 44 FR 11,034; February 26, 1979. For a more detailed discussion, see 76 FR 18,082. This response to the petitions for reconsideration of the final rule is likewise considered to be non-significant under both Executive Orders 12866 and 13563 and DOT policies and procedures. This regulatory action generally clarifies or makes technical amendments to the requirements contained in the final rule or allows for greater flexibility in complying with the rule.

The Regulatory Flexibility Act of 1980 (the Act) (5 U.S.C. 601 et seq. ) and Executive Order 13272 require a review of proposed and final rules to assess their impact on small entities. Prior to issuing the April 1, 2011 final rule, FRA prepared and placed in the docket a regulatory flexibility analysis which assessed the small entity impact by the rule. FRA certified in the final rule that it expects there will be no significant economic impact on a substantial number of small entities. For a more detailed discussion, see 76 FR 18,082. This response to the petitions for reconsideration of the final rule generally clarifies the requirements contained in the rule or allows for greater flexibility in complying with the rule. Consequently, FRA certifies that this regulatory action is not expected to have a significant economic impact on a substantial number of small entities.

The information collection requirements in this final rule and FRA's response to petitions of reconsideration are being submitted for approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq. The section that contains the one new and current information collection requirements is noted below, and the estimated burden time to fulfill each requirement is as follows:

All estimates include the time for reviewing instructions; searching existing data sources; gathering or maintaining the needed data; and reviewing the information. For information or a copy of the information collection submission sent to OMB, please contact Mr. Robert Brogan at 202-493-6292 or Ms. Kimberly Toone at 202-493-6132 or via e-mail at the following addresses: Robert.Brogan@dot.gov; Kimberly.Toone@dot.gov.

Organizations and individuals desiring to submit comments on the collection of information requirements should direct them to the Office of Management and Budget, Office of Information and Regulatory Affairs, 725 17th St., NW., Washington, DC 20503, attn: FRA Desk Officer. Comments may also be sent via e-mail to the Office of Management and Budget at the following address: oira_submissions@omb.eop.gov, mail to: victor.angelo@fra.dot.gov.

OMB is required to make a decision concerning the collection of information requirements contained in response to the petitions of reconsideration of this final rule between 30 and 60 days after publication of this document in the Federal Register . Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication.

FRA cannot impose a penalty on persons for violating information collection requirements which do not display a current OMB control number, if required. FRA intends to obtain current OMB control numbers for any new information collection requirements resulting from this rulemaking action prior to the effective date of this final rule. The OMB control number, when assigned, will be announced by separate notice in the Federal Register.

FRA has evaluated this action in accordance with its “Procedures for Considering Environmental Impacts” (FRA's Procedures) (64 FR 28,545, May 26, 1999) as required by the National Environmental Policy Act (42 U.S.C. 4321 et seq. ), other environmental statutes, Executive Orders, and related regulatory requirements. FRA has determined that this action is not a major FRA action (requiring the preparation of an environmental impact statement or environmental assessment) because it is categorically excluded from detailed environmental review pursuant to section 4(c)(20) of FRA's Procedures. 64 FR 28,547, May 26, 1999. In accordance with section 4(c) and (e) of FRA's Procedures, the agency has further concluded that no extraordinary circumstances exist with respect to this final rule that might trigger the need for a more detailed environmental review. As a result, FRA finds that this regulation is not a major Federal action significantly affecting the quality of the human environment.

Executive Order 13132, “Federalism” (64 FR 43,255, Aug. 10, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, the agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments or the agency consults with State and local government officials early in the process of developing the regulation. Where a regulation has federalism implications and preempts State law, the agency seeks to consult with State and local officials in the process of developing the regulation.

As stated in the preamble to the final rule, FRA has analyzed this final rule in accordance with the principles and criteria contained in Executive Order 13132. FRA has determined that this final rule has no federalism implications, other than the possible preemption of State laws under Sec. 20106. See 76 FR 18,083. This response to the petitions for reconsideration of the final rule generally clarifies the requirements contained in the rule or allows for greater flexibility in complying with the rule.

Pursuant to Sec. 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Sec. 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) [currently $140,800,000] in any 1 year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and tribal governments and the private sector. This response to the petitions for reconsideration of the final rule will not result in the expenditure, in the aggregate, of $140,800,000 or more in any one year, and thus preparation of such a statement is not required.

Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.” See 66 FR 28,355 (May 22, 2001). Under the Executive Order a “significant energy action” is defined as any action by an agency that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and notices of proposed rulemaking: (1)(i) That is a significant regulatory action under Executive Order 12866 or any successor order, and (ii) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (2) that is designated by the Administrator of the Office of Information and Regulatory Affairs as a significant energy action. FRA has evaluated this response to petitions for reconsideration of the final rule in accordance with Executive Order 13211, and has determined that this regulatory action is not a “significant energy action” within the meaning of the Executive Order.

Under the Administrative Procedure Act, an independent Notice of Proposed Rulemaking (NPRM) is not required when an agency, for good cause, finds “that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3)(B). FRA believes that it is making only technical changes, clarifications, and minor amendments in response to petitions for reconsideration of FRA's final rule. For this reason, and because FRA believes that it has provided sufficient opportunities for notice and comment through the NPRM, the final rule, and the petitions for reconsideration which were all contained in the public docket, publishing an independent NPRM is unnecessary.

Anyone is able to search the electronic form of all comments received into any of DOT's dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement published in the Federal Register on April 11, 2000 (Volume 65, Number 70, Pages 19477-78), or you may visit http://DocketsInfo.dot.gov.

In consideration of the foregoing, FRA amends part 213 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:

S7.1.3 of FMVSS No. 213 permits NHTSA to allow manufacturers of CRSs manufactured before August 1, 2010, to choose to have NHTSA test the CRSs with either the H2-6C dummy or the HIII-6C dummy when the CRS is subject to testing with a test dummy representative of a 6-year-old child. 1 NHTSA is amending S7.1.3 to permit manufacturers of currently-manufactured CRSs the choice of NHTSA testing their child restraints with either the H2-6C dummy or the HIII-6C dummy until further notice.

A supplemental notice of proposed rulemaking (SNPRM) preceding this final rule was published on November 24, 2010 (75 FR 71648, Docket No. NHTSA-2010-0158). This final rule is the first of two under the designation RIN 2127-AJ44. The second decisional document will be published later this year. 2

The agency adopted the HIII-6C into FMVSS No. 213 in a final rule  3 published in response to a mandate in the Transportation Recall Enhancement, Accountability and Documentation Act (the TREAD Act) (November 1, 2000, Public Law 106-414, 114 Stat. 1800) that required NHTSA undertake rulemaking on child restraint systems. Section 14 of the TREAD Act directed NHTSA to initiate a rulemaking for the purpose of improving the safety of child restraints by November 1, 2001, and to complete it by issuing a final rule or taking other action by November 1, 2002. Section 14 specified nine elements for consideration by NHTSA in improving child restraint safety, including considering whether to require the use of the HIII-6C and other Hybrid III ATDs in FMVSS No. 213 compliance tests.

Consistent with the TREAD Act, NHTSA decided in its rulemaking to adopt the HIII-6C into FMVSS No. 213. NHTSA considered the dummy to be “considerably more biofidelic” than its predecessor, the H2-6C dummy, and with enhanced potential to measure an array of impact responses never before measured by a child ATD, such as neck moments and chest deflections.

However, the agency acknowledged there was mixed acceptance by the commenters of the HIII-6C dummy. Some commenters believed that the HIII-6C exhibited large neck elongation in the FMVSS No. 213 test environment that resulted in chin-to-chest and head-to-knee contact and correspondingly high head injury criterion (HIC) values. In evaluating those comments, NHTSA carefully analyzed its test data of sled testing conducted with the HIII-6C, but found no data indicating that head-to-chest or head-to-knee impacts were an issue or were typical. 68 FR at 37644. Accordingly, the HIII-6C was adopted into the standard, with what was then considered to be sufficient lead time to enable manufacturers to become familiar with the dummy. The compliance date for the mandatory use of the HIII-6C dummy was set as August 1, 2005.

Eventually, after examining the performance of the HIII-6C in the FMVSS No. 213 environment, NHTSA extended the compliance date to August 1, 2010. 4 We reiterated our belief that the HIII-6C dummy is more biofidelic in its components than its predecessor the H2-6C, and that the HIII-6C also has more extensive instrumentation to measure impact responses such as forces, accelerations, moments and deflections, which are crucial in evaluating vehicle occupant protection systems. 5 Some CRS manufacturers have found the HIII-6C to be a satisfactory test instrument and are using the dummy to certify the compliance of their CRSs to FMVSS No. 213. These manufacturers are positioning the test dummy and measuring the head injury criterion (HIC) as currently required by FMVSS No. 213.

However, while the HIII-6C is an advanced test dummy with state-of-the-art capabilities and is being used to an extent today, NHTSA proposed  6 that the agency should complete ongoing efforts to improve the HIII-6C dummy to make it more useful as an FMVSS No. 213 test device before testing child restraints solely with this device. The HIII-6C dummy has a softer neck than the H2-6C, which results in slightly greater head excursion results and larger HIC values (chin-to-chest contact) than the H2-6C. This, coupled with the stiff thorax of the HIII-6C dummy, accentuates the HIC values recorded by the dummy.

Several measures are underway to improve the Hybrid III dummy (see discussion in 75 FR at 71660). Until such time the HIII-6C is improved, we proposed on November 24, 2010 that FMVSS No. 213 should be amended to permit NHTSA to allow manufacturers the option of specifying that NHTSA use either the H2-6C or the HIII-6C dummy to test the manufacturer's child restraints until further notice.

The agency received three comments on the November 24, 2010 proposal, from: the Juvenile Products Manufacturers Association (JPMA), Evenflo Company Inc. (Evenflo), and the Advocates for Highway Safety (Advocates).

JPMA and Evenflo expressed support for the proposal to reinstate the optional use of the H2-6C and HIII-6C dummies in compliance testing until such time that design issues with the HIII-6C dummy are addressed. JPMA noted that both the HIII-6C and H2-6C dummies are being used to test and certify CRS models to FMVSS No. 213 by various CRS manufacturers. Evenflo noted that the H2-6C has been used for many years to permit qualification of CRSs which have provided good crash protection for children in real world crashes. Both JPMA and Evenflo expressed support of NHTSA's effort to fully implement the HIII-6C dummy into FMVSS No. 213, but noted that it must not be done until the issues with this dummy are addressed.

Advocates stated that it generally opposes allowing alternative compliance options because it allows manufacturers to select the option that affords the widest degree of manufacturing latitude, not necessarily safety protection, and may lead to confusion and ambiguous results. However, it stated that in this particular case, in light of concerns expressed about the biofidelity of the HIII-6C dummy, it understands the necessity to extend the optional use of the H2-6C dummy. Nonetheless, Advocates requested that the period of the extension be limited, and better defined, than simply left open-ended to “until such time FMVSS [No.] 213 is further amended to specify otherwise,” as stated in the preamble of the SNPRM. Advocates suggested that a date certain be established for termination of the optional use of the H2-6C dummy in compliance testing.

For the reasons stated in the November 2010 SNPRM and after consideration of the comments on the proposed optional use of the H2-6C dummy, NHTSA has decided to adopt the proposed amendment to FMVSS No. 213 that allows, at the manufacturer's option, the use of either the H2-6C or the HIII-6C dummy in the agency compliance tests of child restraints.

We understand and generally concur with Advocates' concerns about the potential for compliance options to engender opportunities for confusion and ambiguity about compliance test results. For reasons such as those described by Advocates, NHTSA seeks to avoid incorporating compliance options into the FMVSSs whenever possible. However, in the case at hand, we have decided against establishing a termination date on the optional use of the H2-6C dummy.

As noted in the November 2010 SNPRM and earlier in this document, the agency has research projects underway to improve the capability of child dummies to assess CRS performance. 7 After the agency fully evaluates the new dummy, the improved HIII-6C dummy will be considered for incorporation into FMVSS No. 213 and 49 CFR Part 572. At that time, the agency will consider the mandatory use of the improved dummy in FMVSS No. 213 and the termination of the optional use of the H2-6C dummy in the agency's compliance tests. If a termination date were included in S7.1.3, as the termination date approached, CRS manufacturers using the H2-6C to certify their CRSs may question whether their continued use of the dummy is well-advised. If the HIII-6C dummy were not sufficiently improved by the termination date, as the termination date approached, all CRS manufacturers would again be faced with uncertainty about how NHTSA would test their child restraints. To avoid these uncertainties, we have decided against including a termination date for the optional use of the H2-6C dummy.

This final rule is effective on publication in the Federal Register . There is good cause for this effective date, as this final rule clarifies FMVSS No. 213 requirements as to how NHTSA will test child restraints and provides relief to manufacturers by allowing flexibility in the test dummy used in agency compliance tests of child restraints.

The agency has considered the impact of this rulemaking action under E.O. 12866, E.O. 13563, and the Department of Transportation's regulatory policies and procedures. This action was not reviewed by the Office of Management and Budget under E.O. 12866. This action is not “significant” under the Department of Transportation's regulatory policies and procedures (44 FR 11034; February 26, 1979). The final rule does not impose any new requirements on manufacturers that produce child restraint systems, but only reinstates a provision that allowed NHTSA to provide flexibility to manufacturers in directing NHTSA which test dummy (the H2-6C or the HIII-6C) to use in testing their restraints. The agency believes that the impact is so minimal as to not warrant the preparation of a full regulatory evaluation.

Pursuant to the Regulatory Flexibility Act, we have considered the impacts of this rulemaking action will have on small entities (5 U.S.C. 601 et seq. ). I certify that this rulemaking action will not have a significant economic impact upon a substantial number of small entities within the context of the Regulatory Flexibility Act.

The following is the agency's statement providing the factual basis for the certification (5 U.S.C. 605(b)). This final rule affects child restraint manufacturers. According to the size standards of the Small Business Association (at 13 CFR part 121.601), the small business size standard for manufacturers of “Motor Vehicle Seating and Interior Trim Manufacturing” (NAICS Code 336360) is 500 employees or fewer. Many child restraint manufacturers would be classified as small businesses under this standard. However, the final rule does not impose any new requirements on manufacturers that produce child restraint systems, but only reinstates a provision that allowed manufacturers flexibility in telling NHTSA which test dummy to use in testing their restraints. Accordingly, we have not prepared a Final Regulatory Flexibility Analysis.

NHTSA has examined today's rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and concluded that no additional consultation with States, local governments or their representatives is mandated beyond the rulemaking process. The agency has concluded that the rulemaking would not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. The rule would 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.”

NHTSA rules can preempt in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision: When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1). It is this statutory command by Congress that preempts any non-identical State legislative and administrative law addressing the same aspect of performance.

The express preemption provision described above is subject to a savings clause under which “[c]ompliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law.” 49 U.S.C. 30103(e). Pursuant to this provision, State common law tort causes of action against motor vehicle manufacturers that might otherwise be preempted by the express preemption provision are generally preserved. However, the Supreme Court has recognized the possibility, in some instances, of implied preemption of such State common law tort causes of action by virtue of NHTSA's rules, even if not expressly preempted. This second way that NHTSA rules can preempt is dependent upon there being an actual conflict between an FMVSS and the higher standard that would effectively be imposed on motor vehicle manufacturers if someone obtained a State common law tort judgment against the manufacturer, notwithstanding the manufacturer's compliance with the NHTSA standard. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle manufacturers will generally not be preempted. However, if and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted. See Geier v. American Honda Motor Co., 529 U.S. 861 (2000).

Pursuant to Executive Order 13132 and 12988, NHTSA has considered whether this rule could or should preempt State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation. To this end, the agency has examined the nature ( e.g., the language and structure of the regulatory text) and objectives of today's rule and finds that this rule, like many NHTSA rules, would prescribe only a minimum safety standard. As such, NHTSA does not intend that this rule would preempt state tort law that would effectively impose a higher standard on motor vehicle manufacturers than that established by today's rule. Establishment of a higher standard by means of State tort law would not conflict with the minimum standard adopted here. Without any conflict, there could not be any implied preemption of a State common law tort cause of action.

With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729; Feb. 7, 1996), requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) specifies whether administrative proceedings are to be required before parties file suit in court; (6) adequately defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.

Pursuant to this Order, NHTSA notes as follows. The issue of preemption is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court.

The Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. This action will not result in additional expenditures by state, local or tribal governments or by any members of the private sector. Therefore, the agency has not prepared an economic assessment pursuant to the Unfunded Mandates Reform Act.

Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This final rule does not impose any new collection of information requirements for which a 5 CFR part 1320 clearance must be obtained.

Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78).

We have considered the impacts of this final rule under the National Environmental Policy Act. This rulemaking action only reinstates a provision that allowed NHTSA to provide flexibility to manufacturers in directing NHTSA which test dummy (the H2-6C or the HIII-6C) to use in testing their restraints. This rulemaking does not require any change that would have any environmental impacts. Accordingly, no environmental assessment is required.

The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.

Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

• Have we organized the material to suit the public's needs?

• Are the requirements in the rule clearly stated?

• Does the rule contain technical language or jargon that isn't clear?

• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?

• Would more (but shorter) sections be better?

• Could we improve clarity by adding tables, lists, or diagrams?

• What else could we do to make the rule easier to understand?

If you have any responses to these questions, please send them to NHTSA.

In consideration of the foregoing, NHTSA amends 49 CFR part 571 as set forth below.

Table of Contents I. Background of the ESC Regulation A. Benefits of ESC B. ESC Final Rule C. September 2008 Amendment II. GTR and Petition for Reconsideration A. Global Technical Regulation B. Alliance's Petition for Reconsideration III. Discussion and Analysis of Petition A. ESC Control Identification B. Two-Part Telltales C. Lightweight Outriggers D. Effective Date IV. Rulemaking Analyses and Notices V. Regulatory Text I. Background of the ESC Regulation A. Benefits of ESC

Electronic stability control (ESC) systems use automatic computer-controlled braking of individual wheels to assist the driver in maintaining control in critical driving situations in which the vehicle is beginning to lose directional stability at the rear wheels (spin out) or directional control at the front wheels (plow out). NHTSA's crash data study of existing vehicles equipped with ESC demonstrated that these systems reduce fatal single-vehicle crashes of passenger cars by 55 percent and fatal single-vehicle crashes of light trucks and vans (LTVs) by 50 percent. 1 NHTSA estimates that ESC has the potential to prevent 56 percent of the fatal passenger car rollovers and 74 percent of the fatal LTV first-event rollovers that would otherwise occur in single-vehicle crashes. 2

On April 6, 2007, NHTSA published a final rule establishing Federal Motor Vehicle Safety Standard (FMVSS) No. 126, Electronic Stability Control Systems, which sets forth requirements for ESC systems on new light vehicles. 3 FMVSS No. 126 contains performance requirements that include both definitional and dynamic testing elements. These elements together ensure that ESC systems intervene properly to limit oversteer and understeer in order to provide the level of yaw (directional) stability associated with the high level of safety benefits observed in crash data studies of ESC-equipped vehicles. NHTSA adopted a phase-in schedule to implement this requirement such that all light vehicles manufactured on or after September 1, 2011 must be equipped with a complying ESC system.

FMVSS No. 126 also requires a standardized set of ESC telltales and controls. However, compliance with the telltale and control requirements was deferred until the end of the phase-in period. NHTSA concluded that it was not practicable to implement the telltale and control requirements under the phase-in schedule and was unwilling to delay the phase-in and the expected safety benefits for this reason alone. Accordingly, the provisions in FMVSS No. 126 dealing with telltales and controls are prefaced by the phrase “as of September 1, 2011.”

We received four petitions for reconsideration of the April 2007 final rule. Among the issues raised in the petitions were ones involving details of the requirements for controls and telltales. On September 22, 2008, we published a final rule (September 2008 reconsideration rule) that granted in part and denied in part the petitions. 4 Three of the issues we addressed are pertinent to the issues discussed in this petition for reconsideration of that rule.

First, we granted a petition by Porsche Cars North America, Inc. (Porsche) to allow two-part “ESC Off” telltales. The April 2007 final rule required both an ESC malfunction telltale identified by the ISO symbol for ESC or the abbreviation “ESC” and a second telltale to identify when an ESC system has been turned off by the driver. The second telltale was required to be identified by the ISO symbol for ESC with the word “Off” below it or by the words “ESC Off.” We considered allowing a two-part telltale in the April 2007 final rule, but decided against doing so because we thought that allowing a partial telltale would have created a conflict with the requirement that the ESC Off status be indicated by the ESC Off telltale whenever the driver has manually disabled the ESC system and that an ESC malfunction be indicated separately by the ESC malfunction telltale when an ESC malfunction occurs at the same time.

Porsche petitioned for reconsideration of the April 2007 final rule, stating that its ESC system is designed in a manner such that, in the rare case in which an ESC malfunction occurs after the system has been manually disabled, the system automatically disables the manual control functionality and extinguishes the word “Off' while continuing to illuminate the ESC symbol or abbreviation, thereby indicating the malfunction. Upon reconsideration, NHTSA decided to allow for a two-part telltale rather than requiring manufacturers to maintain separate telltales for ESC malfunction and “ESC Off.” In the September 2008 final rule, we explained that, if an ESC malfunction occurs after a driver has disabled ESC, requiring that both telltales illuminate at the same time, both telltales would communicate the same message to the driver: That the ESC functionality has been reduced or eliminated. Also, we noted our belief that it would be rare for an ESC system to malfunction after it has been manually disabled. Because of that, we believe that requiring both messages to display simultaneously is not necessary for safety. Accordingly, we amended S5.3.3 of FMVSS No. 126 to allow for a two-part “ESC Off” telltale.

Second, we received a petition from the Alliance of Automobile Manufacturers (Alliance) and the Association of International Automobile Manufacturers  5 seeking clarification that an ESC Off control could be included in a multi-function control that could be used to turn ESC off or on and could also be used to turn traction control off and to select an ESC “performance mode” would not be prohibited by FMVSS No. 126. We consider a multi-function control to be a switch or button that combines several functions. As provided by S5.4.3 (formerly S5.4.2), 6 an ESC control whose only purpose is to disable the ESC system or place it in a mode or modes in which it no longer satisfies the performance requirements must be labeled either with the ESC symbol plus the word “Off” or the phrase “ESC Off.” Paragraph S5.4.4 (formerly S5.4.3) creates an exception for a control used primarily for another function, such as a four-wheel drive low-range transfer case, that does not control the ESC system directly but has the ancillary effect of placing the ESC system in a mode that no longer satisfies the performance requirement. We agreed that a multi-function control was permissible, and we clarified S5.4.4 accordingly.

Third, the petition also raised the issue of the identification of multi-function controls and provided an example of a rotary multi-mode control, which is shown in Figure 1 below. We stated that an ESC Off control, regardless of whether it is contained in a multifunction control, must be labeled “ESC Off.” In the case of the example provided in Figure 1, we stated that such a control would not be permissible. In explaining that conclusion, we noted that the “ESC Off” label was not adjacent to the control because a lamp was located between the two, and that the control could be made to comply with FMVSS No. 101 by moving the lamp to the right side of the label.